PROSTHETIC VALVLE FOR INTRALUMINAL IMPLANTATION

• US 20100145438A1
• Filed: 12/08/2008
• Published: 06/10/2010
• Est. Priority Date: 12/08/2008
• Status: Active Grant

• Current Assignee: Hector Daniel Barone
• Original Assignee: Hector Daniel Barone
• Inventors: BARONE, HECTOR DANIEL
• Granted Patent: US 8,591,573 B2
• Time in Patent Office: Days
• US Class Current: 623/2.100
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/008 paraboloidal
• CPC Class Codes: A61F 2250/006 modular
• CPC Class Codes: A61F 2250/0069 Sealing means

Abstract

A prosthetic valve assembly configured to be intraluminally implanted into a lumen of a patient to replace a native deficient valve, the valve assembly comprising an outer support for expanding and anchoring against a lumen wall of the patient, a core valve support made of a collapsible and self-expanding material to expand and anchor into the outer support once anchored against the lumen wall, and a plurality of flexible leaflets fixed to the core valve support in a manner that the leaflets are independent from the outer support.

Claims

1. A prosthetic valve assembly for intraluminal implantation into a lumen of a patient for replacing a native deficient valve, the valve assembly comprising:

an outer balloon expandable support made of a collapsible material and configured to be expanded for anchoring against a lumen wall of the patient and forming a waist section,

a core valve support comprising a collapsible and self-expanding support ring configured to be anchored in the outer balloon expandable support once expanded, the support ring including a plurality of flexible posts upwardly extending from the ring, the core valve support being configured to be collapsed for intraluminal implantation and being configured to expand into the lumen and the outer balloon expandable support once the outer balloon expandable support is anchored against the lumen wall, and

a plurality of flexible leaflets pivotally connected to the collapsible and self-expanding support ring and posts and configured to move between an open position for permitting a blood flow through the valve assembly and a close position for preventing a backflow through the valve assembly.

2. The valve assembly of claim 1, wherein said outer balloon expandable support comprises a radially expandable stent.

3. The valve assembly of claim 1, wherein said waist section is an inextensible section formed in the outer balloon expandable support and configured to be located at an anatomical valve section of the lumen.

4. The valve assembly of claim 3, wherein said inextensible section comprises an inextensible ring.

5. The valve assembly of claim 4, wherein said inextensible ring comprises an inextensible thread.

6. The valve assembly of claim 4, wherein said inextensible ring comprises an inextensible wire.

7. The valve assembly of claim 1, wherein said collapsible and self-expanding support ring includes anchoring means for anchoring the support ring to the outer balloon expandable support.

8. The valve assembly of claim 7, wherein said anchoring means is anchored in the waist section of the outer balloon expandable support when the core valve support is anchored within the outer balloon expandable support and once the outer balloon expandable support is anchored against the lumen wall.

9. The valve assembly of claim 8, wherein said anchoring means comprises a “

C”

cross-section formed in the collapsible and self-expanding support ring with the “

C”

cross-section being open towards the waist section and configured to be coupled to the waist section once the support ring is radially expanded against the outer balloon expandable support.

10. The valve assembly of claim 8, wherein said anchoring means comprises a “

V”

cross-section formed in the collapsible and self-expanding support ring with the “

V”

cross-section being open towards the waist section and configured to be coupled to the waist section once the support ring is radially expanded against the outer balloon expandable support.

11. The valve assembly of claim 8, wherein said anchoring means comprises a plurality of tongues radially outwardly extending from the collapsible and self-expanding support ring with the tongues being open towards the waist section and configured to be coupled to the waist section once the support ring is radially expanded against the outer balloon expandable support.

12. The valve assembly of claim 7, wherein said posts and support ring are an integral collapsible piece with each post having a flexible distal free end.

13. The valve assembly of claim 12, wherein said posts and support ring are made of a shape memory material.

14. The valve assembly of claim 13, wherein said material of the posts and support ring is nitinol.

15. The valve assembly of claim 13, wherein said material of the posts and support ring is stainless steel.

16. The valve assembly of claim 12, wherein each one of the plurality of leaflets has a valley portion thereof fixed to a corresponding portion of the support ring and at least one crest portion thereof fixed at least to the flexible distal free end of a corresponding post.

17. The valve assembly of claim 1, wherein the plurality of leaflets comprises three leaflets.

18. The valve assembly of claim 16, wherein the leaflets are made of natural tissue.

19. The valve assembly of claim 16, wherein the leaflets are made of synthetic material.

20. The valve assembly of claim 16, wherein the support ring is covered by a liner and the leaflets are fixed to the liner.

21. The valve assembly of claim 20, wherein the liner defines said anchoring means.

22. The valve assembly of claim 1, wherein the outer balloon expandable support and the core valve support include respective radio opaque marks for correct positioning purposes.

23. The valve assembly of claim 1, wherein the outer balloon expandable support is provided, at the waist section thereof, with a sealing material to seal against the annulus wall of the patient.