Prosthesis for hernia repair

• US 10,646,321 B2
• Filed: 12/20/2016
• Issued: 05/12/2020
• Est. Priority Date: 01/25/2016
• Status: Active Grant

• Current Assignee: Sofradim Production
• Original Assignee: Sofradim Production
• Inventors: Francois, Sebastien, Therin, Michel, Prost, Nicolas
• Primary Examiner(s): Wilson, Kaylee R
• Application Number:
  US15/384,435
• Publication Number:
  US 20170209251A1
• Time in Patent Office: 1,239 Days
• CPC Class Codes: A61F 2/0063 Implantable repair or support meshes, e.g. hernia meshes
• CPC Class Codes: A61F 2002/0068 having a special mesh pattern
• CPC Class Codes: A61F 2002/009 for hindering or preventing attachment of biological tissue of bone tissue onto implantable joints A61F2002/30932
• CPC Class Codes: A61F 2210/0076 multilayered, e.g. laminated structures
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• CPC Class Codes: A61F 2230/0019 rectangular
• CPC Class Codes: A61F 2240/00 Manufacturing or designing of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
• CPC Class Codes: A61F 2250/0051 differing in tissue ingrowth capacity, e.g. made from both ingrowth-promoting and ingrowth-preventing parts

Abstract

The present invention relates to a prosthesis (1) for hernia repair comprising a reinforcement layer (2), a first barrier layer (3) of anti-adhesion material covering at least a part of a surface of the reinforcement layer, and a second barrier layer of anti-adhesion material covering a remaining part of the surface of the reinforcement layer, the second barrier layer being formed of one or more flap member(s) (4).

Claims

1. A prosthesis for treating a hernia defect in an abdominal wall comprising:

at least one reinforcement layer comprising a biocompatible porous material, said at least one reinforcement layer including a first surface intended to face the abdominal wall and a second surface opposite said first surface, said at least one reinforcement layer being delimited by an outer edge,

at least one first barrier layer comprising a biocompatible anti-adhesion material, said at least one first barrier layer including a first surface and a second surface opposite said first surface of the at least one first barrier layer, the first surface of the at least one first barrier layer covering substantially a central part of an area of the second surface of said at least one reinforcement layer, the second surface of said at least one first barrier layer being intended to face the abdominal cavity, said at least one first barrier layer being delimited by an outer edge,

at least one second barrier layer, said at least one second barrier layer being shaped and dimensioned so as to cover at least a part of a remaining area of the second surface of said at least one reinforcement layer that is not covered by the at least one first barrier layer, said at least one second barrier layer comprising one or more flap members, each of the one or more flap members being formed of a piece of sheet of biocompatible anti-adhesion material, and having at least an outer edge attached to the second surface of the at least one reinforcement layer and a free inner edge, wherein the outer edge of the one or more flap members is spaced from the outer edge of the at least one first barrier layer with at least one protected space on the at least one reinforcement layer positioned therebetween.

2. The prosthesis of claim 1, wherein the one or more flap members include at least a first flap member having a form of an annular band, an outer edge of said first flap member being substantially attached to the second surface of the at least one reinforcement layer along the outer edge of said at least one reinforcement layer.

3. The prosthesis of claim 2, wherein the one or more flap members further comprises at least a second flap member, an outer edge of said second flap member being substantially attached to the second surface of the at least one reinforcement layer along a line located between the outer edge of the at least one reinforcement layer and the outer edge of the at least one first barrier layer.

4. The prosthesis of claim 3, wherein said second flap member has a form of a second annular band, said first and second flap members being concentrically positioned one with respect to the other, so that the outer edge of said second flap member is substantially attached to the second surface of the at least one reinforcement layer along a line substantially parallel to the outer edge of the reinforcement layer, said line being located between the outer edge of the at least one reinforcement layer and the outer edge of the at least one first barrier layer.

5. The prosthesis of claim 3, wherein the one or more flap members further comprises a third flap member having an outer edge, each of said second and third flap member having a form of a tape portion, the respective outer edges of said second and third flap members being substantially attached to the second surface of the at least one reinforcement layer along line(s) located between the outer edge of the at least one reinforcement layer and the outer edge of the at least one first barrier layer, said line(s) being intended to be positioned in regards of a vicinity of edges of the hernia defect.

6. The prosthesis of claim 2, wherein the outer edge of the first flap member is spaced from the outer edge of the second flap member with a first protected space on the at least one reinforcement layer positioned therebetween and the outer edge of the second flap member is spaced from the outer edge of the at least one first barrier layer with a second protected space on the at least one reinforcement layer positioned therebetween.

7. The prosthesis of claim 2, wherein said at least one second barrier layer consists in said first flap member.

8. The prosthesis of claim 2, wherein the outer edge of said first flap member is attached along the outer edge of said at least one reinforcement layer in a continuous way.

9. The prosthesis of claim 2, wherein the outer edge of said first flap member is attached to the second surface of the at least one reinforcement layer so as to define an attaching line which is offset towards a center of the prosthesis from about 0.5 to about 2 cm from the outer edge of said at least one reinforcement layer.

10. The prosthesis of claim 2, wherein the outer edge of said first flap member is attached to the second surface of the at least one reinforcement layer so as to define an attaching line which is offset towards a center of the prosthesis from about 1 cm from the outer edge of said at least one reinforcement layer.

11. The prosthesis of claim 1, wherein the outer edge of said one or more flap members is attached to the second surface of the at least one reinforcement layer by attaching means selected from the group comprising ultrasonic welding, hot compression welding, gluing and combinations thereof.

12. The prosthesis of claim 1, wherein the addition of each area of the one or more flap members amounts altogether to a total area of the one or more flap members which is less than 120% of the remaining area of the second surface of said at least one reinforcement layer that is not covered by the first barrier layer.

13. The prosthesis of claim 1, wherein said at least one second barrier layer is provided with markings intended to indicate to a surgeon where to locate one or more fixing means for fixing the prosthesis to the abdominal wall.

14. The prosthesis according to claim 13, wherein said markings are colored spots located on a surface of said at least one second barrier layer intended to face the abdominal cavity.

15. The prosthesis according to claim 14, wherein said markings are regularly spaced from one another along a perimeter of said at least one second barrier layer.

16. The prosthesis of claim 1, wherein the free inner edge of said one or more flap members is provided with one or more projecting tabs intended to help a surgeon lift said one or more flap members from said at least one reinforcement layer.

17. The prosthesis of claim 1, wherein a smallest dimension of a shape of the piece of sheet of anti-adhesion material forming the one or more flap members ranges from about 1 cm to 4 cm.

18. The prosthesis of claim 17, wherein the smallest dimension of the shape of the piece of sheet of anti-adhesion material forming the one or more flap members ranges from about 2 cm to 3 cm.

19. The prosthesis of claim 1, wherein the one or more flap members forming the at least one second barrier layer provided on a surface facing the at least one reinforcement layer or the at least one first barrier layer with a tacky layer of biocompatible materials capable of sticking to said at least one reinforcement layer or at least one first barrier layer.

20. The prosthesis of claim 1, wherein the free inner edge overlaps the outer edge of the at least one first barrier layer.

21. The prosthesis of claim 3, wherein the at least one protected space includes at least a first protected space and a second protected space, and wherein the outer edge of the first flap member is spaced from the outer edge of the second flap member with the first protected space on the at least one reinforcement layer positioned therebetween, and the outer edge of the second flap member is spaced from the outer edge of the at least one first barrier layer with the second protected space on the at least one reinforcement layer positioned therebetween.