Prosthesis having a radiopaque element

Abstract

The present invention relates to a prosthesis (10) intended to be implanted at an implantation site, comprising i) at least one fabric called the base fabric (2) having at least one apertured surface (3), ii) and at least one patch (4) provided with at least one barb (5) projecting from one of its surfaces and grippingly fastening said patch to said apertured surface of said base fabric at a specific place on said surface, said patch comprising at least one radiopaque element. The invention also relates to a kit comprising a fabric and a patch.

Claims

1. A prosthesis comprising: i) at least one base fabric having at least one apertured surface which promotes penetration of cells into the base fabric and cell recolonization of the prosthesis after implantation, ii) and a plurality of repositionable gripping fabrics separate from the at least one base fabric, each repositionable gripping fabric in the form of a disc having a first apertured surface, a second surface opposite the first surface, at least one radiopaque element, and at least one barb projecting from the second surface of the repositionable gripping fabric and designed to grippingly fasten the repositionable gripping fabric to a first specific place on the at least one apertured surface of the at least one base fabric and is easily removed therefrom so as to be repositioned and refastened on a second specific place on the at least one apertured surface of the at least one base fabric, wherein each gripping fabric has an area ranging from 0.5 to 6 cm.sup.2 and the first apertured surface promotes penetration of cells and preserves the cell recolonization of the prosthesis when the second surface of the gripping fabric is grippingly fastened to the apertured surface of the base fabric.

2. The prosthesis according to claim 1, wherein the at least one base fabric has two apertured surfaces and one or more repositionable gripping fabrics are grippingly fastened to each of the two apertured surfaces.

3. The prosthesis according to claim 1, wherein the at least one base fabric is a knit.

4. The prosthesis according to claim 1, wherein the at least one barb is formed from a yarn made of a radiopaque material and constitutes the at least one radiopaque element of each repositionable gripping fabric.

5. The prosthesis according to claim 1, wherein the at least one radiopaque element includes one or more radiopaque monofilament yarns forming each gripping fabric.

6. The prosthesis according to claim 1, wherein the at least one radiopaque element is in the form of a coating made of radiopaque material deposited on at least one surface of each repositionable gripping fabric.

7. The prosthesis according to claim 1, wherein the at least one radiopaque element is in the form of a coating made of radiopaque material deposited on a surface of each of the repositionable gripping fabrics by plasma-enhanced chemical vapor deposition.

8. The prosthesis according to claim 1, wherein the plurality of repositionable gripping fabrics includes four repositionable gripping fabrics, each repositionable gripping fabric grippingly fastened to a corner of the base fabric.

9. The prosthesis according to claim 1, wherein the at least one base fabric is a three-dimensional knit.

10. A kit comprising: at least one base fabric having at least one apertured surface which promotes penetration of cells into the base fabric and cell recolonization of the prosthesis, and, a plurality of repositionable gripping fabrics separate from the at least one base fabric, each repositionable gripping fabric in the form of a disc having a first apertured surface, a second surface opposite the first surface, at least one radiopaque element and at least one barb projecting from the second surface of each repositionable gripping fabric, said at least one barb designed for grippingly fastening each repositionable gripping fabric to at a first specific place on the at least one apertured surface of the at least one base fabric and easily removed therefrom so as to be repositioned and refastened on a second specific place on the at least one apertured surface of the at least one base fabric, wherein each gripping fabric has an area ranging from 0.5 to 6 cm.sup.2 and the first apertured surface promotes penetration of cells and preserves the cell recolonization of the prosthesis when the second surface of the gripping fabric is grippingly fastened to the apertured surface of the base fabric.

11. A prosthesis comprising: i) at least one base fabric having at least one apertured surface which promotes penetration of cells into the base fabric and cell recolonization of the prosthesis after implantation, and ii) a plurality of planar repositionable gripping fabrics separate from the at least one base fabric, each planar repositionable gripping fabric having a first apertured surface, a second surface opposite the first surface, at least one radiopaque element, and at least one barb projecting from the second surface of the repositionable gripping fabric and designed to grippingly fasten the second surface of the repositionable gripping fabric to a first specific place on the at least one apertured surface of the at least one base fabric and is easily removed therefrom so as to be repositioned and refastened on a second specific place on the at least one apertured surface of the at least one base fabric, wherein the first apertured surface of the gripping fabric promotes penetration of cells and preserves the cell recolonization of the prosthesis when the second surface of the gripping fabric is grippingly fastened to the apertured surface of the base fabric.

Description

(1) The advantages of the present invention will become more clearly apparent in the light of the following description and the appended drawings in which:

(2) FIG. 1 is a top view of a kit according to the invention;

(3) FIG. 2 is a cross-sectional view of a patch of a prosthesis according to the invention; and

(4) FIG. 3 is a top view of a prosthesis according to the invention.

(5) Referring usefully to FIG. 1, a kit according to the present invention is shown in general by the reference 1. The kit 1 comprises a base fabric in the form of a piece of fabric 2 of rectangular overall shape. This piece of fabric 2 may have an area ranging from 4 to 1600 cm.sup.2 and may advantageously be used for repairing an abdominal wall hernia. The piece of fabric 2 has two surfaces, an apertured surface 3 of which is visible in the figure.

(6) Such a fabric with at least one apertured surface may be obtained using the following method: a three-dimensional knit is produced on a 22-gauge Raschel knitting machine using six needle-guide bars threaded one full/one empty with polyethylene terephthalate (PET) multifilament yarns (50 dtex; 22 filaments), using the following schemes, according to ISO 11676:

(7) Bar 1: 1.2.1.1/1.0.1.1/1.2.1.1/1.0.1.1/1.2.2.2/3.2.2.2/1.2.2.2/3.2.2.2//

(8) Bar 2: 1.2.2.2/3.2.2.2/1.2.2.2/3.2.2.2/1.2.1.1/1.0.1.1/1.2.1.1/1.0.1.1//

(9) Bar 3: 0.1.0.1/0.0.0.0//

(10) Bar 4: 0.1.0.1/0.0.0.0//

(11) Bar 5: 1.1.0.1/1.1.2.1/1.1.0.1/1.1.2.1/2.2.2.3/2.2.2.1/2.2.2.3/2.2.2.1//

(12) Bar 6: 2.2.2.3/2.2.2.1/2.2.2.3/2.2.2.1/1.1.0.1/1.1.2.1/1.1.01/1.1.2.1//

(13) Bars 1 and 2 form one surface of the fabric, bars 5 and 6 form the opposite surface of the fabric and bars 3 and 4 form the spacer linking the two surfaces together.

(14) Such a construction results in a three-dimensional knit having openings measuring about 2.51.7 mm on both its surfaces.

(15) FIG. 1 also shows four patches 4 each taking the overall form of a disc. Each of these patches is provided with barbs 5 projecting perpendicular to one of their surfaces, as shown in FIG. 2, which is a cross-sectional view of a patch 4.

(16) In this example, the patches 4 are made of a gripping fabric obtained in the following manner: a knit is produced on a 24-gauge weft knitting machine using 3 needle-guide bars. Bars 1 and 2, intended to form the body of the gripping fabric, are threaded one full/one empty with 0.09 mm diameter polyethylene terephtalate (PET) monofilament yarns according to the following schemes, according to ISO 11676:

(17) Bar 1: 1.0/0.1//

(18) Bar 2: 4.5/1.0//.

(19) Bar 3, intended to form the monofilament lap resulting in the barbs is threaded 1 full/3 empty with a 0.15 mm diameter polylactic acid (PLA) monofilament yarn according to the following scheme, according to ISO 11676:

(20) Bar 3: 3.4/0.0/2.1/5.5//.

(21) The barbs are then produced by melting the loops of the lap produced by bar 3 according to the method described in WO 01/81667.

(22) Both surfaces of the gripping fabric are then coated with gold by plasma-enhanced chemical vapour deposition (PECVD).

(23) Next, the resulting coated gripping fabric is cut into four patches: these patches may have an area ranging for example from 0.5 to 6 cm.sup.2, depending on the desired radiopacity for the radiography.

(24) FIG. 3 shows a prosthesis 10 according to the invention produced from the kit 1 of FIG. 1. To produce the prosthesis 10, the four patches 4, with the barbs 5 directed towards the apertured surface 3 of the piece of base fabric 2, have simply been applied and pressure exerted thereon. The four patches 4 were applied at specific places on the apertured surface 3 of the base fabric, namely each at one corner of the base fabric 2, so that the surgeon can easily determine the position of the prosthesis by radioscopy once said prosthesis has been implanted. The position of the prosthesis 10 within the patient's body may thus be checked several weeks or months after implantation.

(25) The prosthesis 10 was thus produced in a simple and particularly rapid manner. It may especially be produced easily by the surgeon himself just before implantation.

(26) In a non-illustrated embodiment, the four patches may each comprise a yarn made of radiopaque material defining a particular shape, for example a circle, a cross, a triangle and so on, so that the surgeon may determine exactly which corner of the prosthesis is positioned at which place.