VALVE PROSTHESIS FOR IMPLANTATION IN BODY CHANNELS

• US 20090254176A1
• Filed: 03/26/2009
• Published: 10/08/2009
• Est. Priority Date: 03/27/2008
• Status: Active Grant

• Current Assignee: Genomnia Srl
• Original Assignee: ab medica SpA
• Inventors: Butera, Gianfranco
• Granted Patent: US 9,421,095 B2
• Time in Patent Office: Days
• US Class Current: 623/1.240
• 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 characterised 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. Valve prosthesis comprising a stent and characterised in that it comprises a valve arranged in said stent and bound thereto in at least one pre-established zone so that it can be deformed between a closed state in which said valve is entirely spread out in the stent, thus blocking the passage of a body fluid, and an open state in which said valve, due to the pressure of said body fluid, is substantially collapsed on an inner wall of said stent, thus permitting the flow of said body fluid.

2. Valve prosthesis according to claim 1, characterised in that said valve has a monocusp sail-like form in its spread out state, with substantially triangular longitudinal section and with rounded corners.

3. Valve prosthesis according to claim 2, characterised in that said valve has a curvature of its concave surface towards the base of said monocusp sail-like form.

4. Valve prosthesis according to claim 2, characterised in that said valve is arranged tilted with reference to the longitudinal axis of the stent by an acute angle with respect to such axis in the range of 35°

-50°

, preferably 45°

.

5. Valve prosthesis according to claim 1, characterised in that said valve is made of a biocompatible synthetic material.

6. Valve prosthesis according to claim 5, characterised in that said material is ePTFE.

7. Valve prosthesis according to claim 1, characterised in that said stent is composed of a lattice having longitudinal elements and transverse elements crossed with each other, said lattice being expandable from a compressed state to a state of maximum expansion.

8. Valve prosthesis according to claim 7, characterised in that said stent is made of a metal or plastic material.

9. Valve prosthesis according to claim 7, characterised in that said stent has an inner and/or outer coating of biocompatible material, preferably ePTFE.

10. Valve prosthesis according to claim 7, characterised in that said stent has a flaring at a respective proximal end portion and/or distal end portion.

11. Valve prosthesis according to claim 1, characterised in that, in said pre-established zone, the valve is connected to the stent along at least two junction lines extended in the longitudinal direction of the stent and forming an acute angle with each other.

12. Valve prosthesis according to claim 11, characterised in that, in said pre-established zone, the valve is connected to the stent along two junction lines, essentially V-shaped, extended in the longitudinal direction of the stent.

13. Valve prosthesis according to claim 1, characterised in that said valve is bound, in said pre-established zone of the stent, by means of affixing continuous or separate points, by glue positioning or by means of moulding.

14. Valve prosthesis according to claim 13, characterised in that said valve is bound to said stent by means of the application of a plurality of suture points along two junction lines extended in the longitudinal direction between the apex and the base, said suture points binding the valve to corresponding longitudinal elements or transverse elements of the lattice composing the stent and/or at intersections between said longitudinal or transverse elements.

15. Method for making a valve prosthesis according to claim 1, the method being characterised in that it comprises the steps of:

providing a stent of material expandable from a compressed state to a fully expanded state,

making a valve of biocompatible synthetic material or providing a biological material valve,

coupling said valve in at least one pre-established zone of said stent in its fully expanded state so that the valve can be deformed between a closed state in which said valve is fully spread out in the stent, thus blocking the passage of a body fluid, and an open state in which said valve, due to the pressure of said body fluid, is substantially collapsed on an inner wall of said stent, thus permitting the flow of said body fluid.

16. Method according to claim 15, characterised in that said valve has monocusp sail-like form and is made from a sheet of thickness in the range of 0.08 mm-1.12 mm.

17. Method according to claim 15, characterised in that, in said pre-established zone, the valve is connected to the stent along at least two junction lines extended in the longitudinal direction of the stent and forming an acute angle with each other.

18. Method according to claim 17, characterised in that, in said pre-established zone, the valve is connected to the stent along two junction lines, essentially V-shaped, extended in the longitudinal direction of the stent.

19. Method according to claim 17, characterised in that the valve is coupled to the stent by means of application of a plurality of suture points along two junction lines extended in the longitudinal direction between the apex and the base of said monocusp sail-like form, said suture points binding the valve to corresponding longitudinal or transverse elements of the lattice composing the stent and/or at intersections between said longitudinal elements and transverse elements.