Valve prosthesis for implantation in body channels

• US 9,421,095 B2
• Filed: 03/26/2009
• Issued: 08/23/2016
• Est. Priority Date: 03/27/2008
• Status: Active Grant

• Current Assignee: Genomnia Srl
• Original Assignee: Genomnia Srl
• Inventors: Butera, Gianfranco
• Primary Examiner(s): Woznicki, Jacqueline
• Application Number:
  US12/411,870
• Publication Number:
  US 20090254176A1
• Time in Patent Office: 2,707 Days
• Field of Search: 623/1.24, 623/2.14, 623/2.17, 623/2.18, 623/2.11, 623/2.1, 623/2.12
• US Class Current: 1/1
• CPC Class Codes: A61F 2/2403 with pivoting rigid closure members check valves with hinged closure members in general F16K15/03
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2415 Manufacturing methods
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2475 Venous valves
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0067 conical
• CPC Class Codes: A61F 2250/0082 specially designed for children, e.g. having means for adjusting to their growth

Abstract

The present invention regards a valve prosthesis (1; 40; 50; 60) comprising a stent (2) and characterized in that it comprises a valve (3) arranged in said stent (2) and bound thereto in at least one pre-established zone so that it can be deformed between a closed state in which said valve (3) is fully spread out in the stent (2), thus blocking the passage of a body fluid, and an open state in which said valve (3), due to the pressure of said body fluid, is substantially collapsed on an inner wall of said stent (2), thus permitting the flow of said body fluid. The invention also regards a method for making said valve prosthesis.

Claims

1. A cardiac valve prosthesis comprising:

a stent, which is cylindrical and expandable from a compressed state for percutaneous implantation, to an expanded state for anchoring to a vessel, said stent including a distal end and a proximal end located at terminal ends of said stent, and formed from a plurality of longitudinal rectilinear elements abutting a plurality of, separate and distinct, crossed transverse elements whereby each of said crossed transverse elements traverse and cross each of said longitudinal rectilinear elements, and each of said longitudinal rectilinear elements extend continuously from said distal end to said proximal end substantially parallel to a longitudinal axis of said stent;

a plurality of sutures; and

a triangular cardiac valve having a first side and second side both extending from an apex of said valve to an opposite base of said valve, said valve arranged in said stent and being bound to said stent in a pre-established zone along said longitudinal rectilinear elements and said crossed transverse elements by said sutures at a plurality of suture points along said first side and said second side of said valve thereby binding said valve to said longitudinal rectilinear elements and said crossed transverse elements, wherein said valve is connected to said stent in said pre-established zone along at least two junction lines tracking said first and second sides of said valve whereby said junction lines form an acute angle with each other at a position proximal to said apex of said valve.

2. The cardiac valve prosthesis according to claim 1, wherein said valve in said expanded state has a substantially triangular longitudinal section and rounded corners.

3. The cardiac valve prosthesis according to claim 2, wherein said valve has a curvature of a concave surface as said valve extends from said apex to said base.

4. The cardiac valve prosthesis according to claim 2, wherein said valve in said expanded state exhibits a slope at an angle of 35-50°

with reference to a longitudinal axis of said stent.

5. The cardiac valve prosthesis according to claim 4, wherein said valve exhibits said slope with reference to the longitudinal axis of said stent of about 45°

.

6. The cardiac valve prosthesis according to claim 1, wherein said valve is made of a biocompatible synthetic material.

7. The cardiac valve prosthesis according to claim 6, wherein said material is ePTFE.

8. The cardiac valve prosthesis according to claim 1, wherein said stent is made of a metal or plastic material.

9. The cardiac valve prosthesis according to claim 1, wherein said stent has an inner coating, an outer coating, or both said inner coating and said outer coating of biocompatible material.

10. The cardiac valve prosthesis according to claim 1, wherein said stent has a flaring at said proximal end, at said distal end, or at both said proximal end and said distal end.

11. The cardiac valve prosthesis according to claim 1, wherein said stent has an inner or outer coating of ePTFE.

12. The cardiac valve prosthesis according to claim 1, wherein said crossed transverse elements extend substantially perpendicular to said longitudinal rectilinear elements.

13. The cardiac valve prosthesis according to claim 12, wherein said crossed transverse elements extend in a zig-zag manner.

14. A method for making a cardiac valve prosthesis according to claim 1, wherein the method comprises the steps of:

providing a stent of material expandable from a compressed state to a fully expanded state, said stent including a distal end and a proximal end located at terminal ends of said stent, and formed from a plurality of longitudinal rectilinear elements abutting a plurality of, separate and distinct, crossed transverse elements whereby each of said crossed transverse elements traverse and cross each of said longitudinal rectilinear elements, and each of said longitudinal rectilinear elements extend continuously from said distal end to said proximal end substantially parallel to a longitudinal axis of said stent;

providing a triangular cardiac valve of biocompatible or biological material, said valve having a first side and a second side both extending from an apex of said valve to an opposite base of said valve; and

suturing said valve to said stent in a pre-established zone along said longitudinal rectilinear elements and said crossed transverse elements at a plurality of suture points along said first side and said second side of said valve thereby binding said valve to said longitudinal rectilinear elements and said crossed transverse elements, wherein said valve is connected to said stent in said pre-established zone along two junction lines tracking said first and second sides of said valve whereby said junction lines form an acute angle with each other at a position proximal to said apex of said valve.

15. The method according to claim 14, wherein said valve is made from a sheet of thickness in the range of 0.08 mm-1.12 mm.

16. The method according to claim 14, wherein said crossed transverse elements extend substantially perpendicular to said longitudinal rectilinear elements.

17. The method according to claim 16, wherein said crossed transverse elements extend in a zig-zag manner.