Two-layer surgical prosthesis for soft tissue replacement

FIELD: medicine.

SUBSTANCE: invention refers to medicine. What is described is a prosthesis, particularly for treating hernias and/or abdominal hernias by the intraperitoneal introduction, containing a fibre mesh of a non-absorbable and biologically compatible polymer material having lumens enabling tissue engraftment, and a sheet of polymer material possessing the barrier properties and having poor adhesion to sensible organs and tissues. The sheet is applied on the mesh and coupled therein to form a layered structure. The sheet is attached to the mesh by means of a number of connective fibres adjoining each other with a gap making max. 5 mm. Each fibre has a number of attachment points to the mesh at a distance of max. 15 mm, and each fibre section between the two adjoining attachment points projects from the mesh surface facing the sheet and welded to the sheet.

EFFECT: prosthesis has reduced weight for reduction of the inflammatory reaction and abdominal rigidity, and improved patient's comfort and quality of life.

10 cl, 3 dwg

 

The present invention relates to a surgical prosthesis for replacement of soft tissues, in particular for the treatment of hernias and/or abdominal hernia, or defects of the abdominal wall, by intraperitoneal injection.

More specifically, this prosthesis contains a grid of fibers and non-absorbable biocompatible polymeric material having openings that allow the germination of the fabric and the sheet of polymeric material having barrier properties and having a weak adhesion to sensitive organs and tissues, and the sheet placed on the grid and connected with her for the formation of the layered structure.

In operation, the prosthesis is implanted so that the grid was in contact with the abdominal wall, strengthen and stimulate fibroblastic reaction, and the barrier layer were in contact with internal organs to minimize sticking.

Known prosthesis of this type is described in U.S. patent No. 6270530. In this prosthesis grid is connected with the sheet with the help of one of the intermediate grid, which is sewn to the first grid on the one hand and preplavljena to the barrier sheet to another using a process based on the creation of high temperature and pressure.

The presence of one of the intermediate grid makes the design of the prosthesis rather thick, hard and heavy. As a result, its hard to turn for the introduction of br is used cavity, using a trocar (i.e. instrument, which, after creation of pneumoperitoneum makes possible the introduction of surgical instruments through the holes made in the abdominal wall), which limits opportunities for implantation. In addition, a large amount of material present in these prostheses, contrary to the concept of "less is more"made U.Klinge and V.Schumpelick in the "Prosthetic implants for hernia repair" BJS, Vol.90 (12), Dec.2003:1457-1458. According to this concept, the quantity and quality of the inflammatory response directly correlates with the number of implanted prosthetic material and the surface area in contact with tissue of the body. In particular, this inflammatory response is the cause of the formation of scar tissue, which covers the grid, giving it rigidity and causing discomfort and pain to the patient.

Therefore, the objective of the present invention to provide an improved prosthesis in comparison with the known prostheses.

According to the invention results from the surgical prosthesis for replacement of soft tissues, in particular for the treatment of hernias and/or abdominal hernias by intraperitoneal injection containing the grid, made from fibers of polypropylene having openings that allow the germination of the fabric, and a sheet made of stretched polytetrafluoroethylene having barrier is foistware and having weak adhesion to sensitive organs and tissues, moreover, the sheet placed on the grid and connected with her for the formation of the layered structure through a set of connective fibers arranged next to each other with a gap constituting not more than 5 mm, and each of the connecting fiber has many places of attachment to the grid with a distance between them of not more than 15 mm, and each fiber span between two adjacent seats of attachment is on the surface of the grid facing the sheet, and problable to the sheet.

Connective fibers may be made from polypropylene.

The ratio of the diameters of the connecting fibers and the fibers forming the mesh may be in the range between 1.1 and 2.

Connective fibers can be located next to each other with a gap constituting not more than 3 mm, and preferably between 1 and 2 mm Connective fibers can be located, essentially, with the same clearances.

Stretches the connective fibers between two adjacent seats of attaching the fiber to the grid can have a length of not more than 10 mm and preferably between 5 and 9 mm of the Specified line segments connecting fibers can have essentially the same length, so the insertion of various connective fibers are arranged in rows parallel to each other and essentially perpendicular to the adjacent line segments to connect the sustained fashion fibers.

The sheet may be connected with the connecting fibers by hot rolling.

The prosthesis can have only the mesh and sheet, United connective fibers.

In the prosthesis according to the invention the connective fibers act as spacer elements located between the mesh and the sheet to prevent damage to the grid and/or integrity of the barrier film during the process of fusing them with the sheet and prevent overlap of openings of the grid. At the same time, the connective fibers have mass and stiffness, much smaller than the intermediate mesh or other connecting means, which simplifies handling of the prosthesis and improves the flexibility of the prosthesis according to the invention.

Therefore, the design created prosthesis allows the implant to trim it to the required shapes and sizes without any damage and loss of fibers grid collapsed for introduction into the abdominal cavity using a trocar, and easy to spread it on the anatomical site of implantation.

After implantation of the prosthesis according to the invention has such elasticity and strength so that, for example, to provide a response that is compatible with normal physiological responses and anatomical and biomechanical dynamics of the abdominal wall without separation of the grid from the sheet and/or without a perforated sheet mesh.

Approximately t Lina prosthesis according to the invention lies in the range between 0.4 and 0.6 mm, the weight per unit area of the surface lies in the range between 60 and 100 g/m2and the tensile strength is greater than the maximum intra-abdominal pressure measured using the principle of hydrostatics Pascal and equal to 16 N/cm, as determined Klinge u, Klosterhalfen Century, Conze j, and others in the "Modified mesh for hernia repair that is adapted to the discrimination of abdominal wall", Eur J Surg 164:951-960, 1998.

In General, the prosthesis according to the invention has a smaller thickness, which allows to embed it using a trocar having small dimensions and reduced weight to reduce the inflammatory response and rigidity of the abdominal wall and improve comfort and quality of life of the patient.

Other advantages and features of the present invention will become apparent from the following detailed description which is given with reference to the attached drawings, given solely as a non-limiting example, which depicts the following:

figure 1 is a view in partial mirovom prosthesis according to the invention;

2 is a top view in an enlarged scale of the grid, forming part of the prosthesis depicted in figure 1;

3 is a view in section in an enlarged scale along the line III-III in figure 1.

Surgical prosthesis for replacement of soft tissues, in particular for the treatment of hernias and/or abdominal hernias by intraperitoneal injection, contains a grid 10 of non-absorbable fibers Biologicheskie compatible synthetic polymer material such as polypropylene, having openings that allow the germination of the fabric, and a sheet 12 of polymeric material having barrier properties and poor adhesion to sensitive organs and tissues of the body, such as a stretched polytetrafluoroethylene. The sheet 12 placed on the grid 10 and is connected with it many connective fibers 14 for the formation of the layered structure.

The material used for the connecting fibers 14 may, for example, be monovacancy polypropylene.

Connective fibers 14 are located next to each other, preferably, essentially, with the same gaps 16, constituting not more than 5 mm, preferably not more than 3 mm and even more preferably from 1 to 2 mm.

Each fiber 14 has many places 18 attached to the grid 10, the distance between which is less than 15 mm and preferably not more than 10 mm, so that these segments 20 of the fiber 14 between two adjacent seats 18 are attached to the surface of the grid 10 in the direction of the sheet 12. Preferably all the segments 20 of the fibers 14 have the same length between 5 and 9 mm in such a way that such places 18 attach different fibers 14 are arranged in rows 22, parallel to each other and essentially perpendicular to the adjacent segments 20 of the fibers 14.

Preferably, the diameter of the connecting fibers 14 is larger than the diameter of the fibers is etki 10, so the ratio of these diameters is in the range between 1.1 and 2. Approximately the diameter of the connecting fibers 14 is in the range between 160 and 200 μm, while the diameter of the fibers of the mesh 10 is between 100 and 140 μm.

In addition to snap to the grid 10 of the connecting fibers 14 problemsets to the sheet 12 on the protruding portion of the valve 20, which act as bridges between adjacent seats 18 attachment. The fusion is performed using conventional procedures, for example, through the combined effects of high temperature and pressure during hot rolling. During the last and later when using the connective fibers 14 hold the mesh 10 at a distance from the sheet 12, not allowing gaps, which are essential to the germination of the tissue to be closed, preventing perforation of sheet fiber mesh 10 that will violate its integrity.

In General provides linked the design of the prosthesis, which is resistant to tearing and delamination, as well as elastic and flexible.

It is clear that the scope of the present invention and its variants implementation and design elements can vary significantly in relation to the described and illustrated embodiments which have been given solely as an example, without deviation from the scope of the invention defined by pilage the second formula.

1. Surgical prosthesis for replacement of soft tissues, in particular, for the treatment of hernias and/or abdominal hernias by intraperitoneal injection containing the grid, made from fibers of polypropylene having openings that allow the germination of the fabric, and a sheet made of stretched polytetrafluoroethylene having barrier properties and poor adhesion to sensitive organs and tissues, and the sheet placed on the grid and connected with her for the formation of the layered structure through a set of connective fibers arranged next to each other with a gap constituting not more than 5 mm, and each of the connecting fiber has many places of attachment to the grid with distance between them of not more than 15 mm, and each fiber span between two adjacent seats of attachment is on the surface of the grid facing the sheet, and problable to the sheet.

2. The prosthesis according to claim 1, in which the connective fibers made from polypropylene.

3. The prosthesis according to claim 1 or 2, in which the ratio of the diameters of the connective fibers and the fibers forming the mesh is in the range between 1.1 and 2.

4. The prosthesis according to claim 1 or 2, in which the connective fibers are located next to each other with a gap constituting not more than 3 mm, and preferably between 1 and 2 mm.

5. The prosthesis according to claim 1 or 2, in which the connective fibers in Berlin the wife, essentially, with the same clearances.

6. The prosthesis according to claim 1 or 2, which stretches the connective fibers between two adjacent seats attaching fibers to the grid have a length of not more than 10 mm and preferably between 5 and 9 mm

7. The prosthesis according to claim 1, in which all of these stretches the connective fibers have essentially the same length, so the insertion of various connective fibers are arranged in rows parallel to each other and essentially perpendicular to the adjacent segments of the connecting fibers.

8. The prosthesis according to claim 1 or 2, which has a thickness in the range between 0.4 and 0.6 mm

9. The prosthesis according to claim 1 or 2, in which the sheet is connected with the connecting fibers by hot rolling.

10. The prosthesis according to claim 1 or 2, containing only the mesh and sheets connected by the connecting fibers.



 

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5 cl, 4 ex, 4 dwg

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2 cl, 1 ex, 3 dwg

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FIELD: medicine.

SUBSTANCE: invention relates to medical equipment, namely to implantable device. Implantable device for application in human and/or animal body aimed at closing or partial closing openings of defects, cavities, canals, ducts in organs, etc. or creation of specified connecting opening between walls, organs, cavities, etc., has bearing structure. Primary form of bearing structure has larger ratio of length to transverse dimension along axis, and secondary form - smaller ratio of length to transverse dimension along axis. Bearing structure includes proximal section and distal section and has form of lattice and/or cloth and/or canvas and/or mesh. At least one section in secondary form contains two parts, one of which is the first to extend from primary form into secondary form and folds in direction from the other section onto the second part, directed towards said other section. Folded part folds back inside implanted device. Said device is used as vessel filter and/or device for removal of foreign particles, or as stent.

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26 cl, 172 dwg

FIELD: medicine, pharmaceutics.

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26 cl, 1 dwg, 8 ex

FIELD: medicinal equipment.

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EFFECT: higher efficiency.

20 cl, 8 dwg

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