Rolled minimally-invasive heart valves and methods of use

• US 20020138138A1
• Filed: 03/23/2001
• Published: 09/26/2002
• Est. Priority Date: 03/23/2001
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Yang, Jibin
• Granted Patent: US 6,733,525 B2
• Time in Patent Office: Days
• US Class Current: 623/2.18
• 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 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/848 having means for fixation to the vessel wall, e.g. barbs
• CPC Class Codes: A61F 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: A61F 2/92 Stents in the form of a rolled-up sheet expanding after insertion into the vessel , e.g. with a spiral shape in cross-section
• 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 2250/006 modular
• CPC Class Codes: Y10S 623/90 Stent for heart valve

Abstract

Expandable heart valves for minimally invasive valve replacement surgeries are disclosed. The valves are rolled into a first, contracted configuration for minimally invasive delivery and then unrolled or unfurled at the implantation site. One- and two-piece stents may be used in conjunction with a plurality of flexible leaflet-forming membranes. The one-piece stents may include an annulus anchoring section, a sinus section with the membranes attached over sinus apertures, and a rigid outflow section. The two-piece stent may include a primary stent to provide a tubular base at the annulus, and a secondary stent having the membranes that couples within the primary stent. Lockout tabs to secure the stents in their expanded shapes are provided. Also, alignment structure may be provided to ensure concentric unfurling. Anchoring barbs at the stent edges or in the stent body secure the valve within the annulus. Methods of implantation are also provided.

Claims

1. A prosthetic heart valve suitable for minimally invasive delivery, comprising:

a generally sheet-like stent body having a first, contracted configuration in which the stent body is spirally-wound about an axis such that at least one winding of the stent body surrounds another winding, and a second, expanded configuration in which the stent body is substantially unwound and at least partly forms a tube centered about the axis and sized to engage an annulus of a patient'"'"'s heart valve; and

a plurality of flexible, biocompatible membranes incorporated into the stent body to form heart valve leaflets in the second configuration.

2. The heart valve of claim 1, wherein the stent body comprises a primary stent coupled to a secondary stent that at least partially fits within the primary stent.

3. The heart valve of claim 2, wherein the membranes are incorporated into the secondary stent.

4. The heart valve of claim 1, wherein the stent body is formed of a single stent.

5. The heart valve of claim 1, wherein the stent body has a plurality of sinus apertures and an outer edge of each biocompatible membrane fastens around the edge of an aperture.

6. The heart valve of claim 5, wherein the sinus apertures are generally semi-circular.

7. The heart valve of claim 5, wherein the sinus apertures are generally oval.

8. The heart valve of claim 5, wherein the outer edge of each membrane is folded over to contact an inner surface of the stent body adjacent an edge of the associated aperture.

9. The heart valve of claim 1, further including at least one guide to insure concentricity of the sheet-like stent body about the axis during a conversion between the first, contracted configuration to the second, expanded configuration.

10. The heart valve of claim 9, wherein the stent body defines a pair of opposed side edges that generally mate in the second, expanded configuration, and a pair of opposed end edges that extend between the side edges, and the at least one guide comprises a tab extending generally radially along each one of the end edges.

11. The heart valve of claim 9, wherein the at least one guide comprises a tab extending generally radially from the stent body and a cooperating slot in the stent body circumferentially spaced from and axially aligned with the tab, the tab being configured to enter and be retained within the slot during the conversion between the first, contracted configuration to the second, expanded configuration.

12. The heart valve of claim 1, wherein the stent body defines a pair of opposed side edges that generally mate in the second, expanded configuration, the stent body further including lockout structure to retain the opposed side edges in mating engagement.

13. The heart valve of claim 12, wherein the lockout structure comprises tabs formed adjacent one of the side edges and apertures formed adjacent the other of the side edges that are sized to receive and retain the tabs.

14. The heart valve of claim 12, wherein the lockout structure both prevents further expansion of the stent body and contraction from the expanded tubular shape.

15. The heart valve of claim 1, further including at least one anchoring barb extending radially outward from the stent body in the second, expanded configuration.

16. The heart valve of claim 15, wherein the stent body defines a pair of opposed side edges that generally mate in the second, expanded configuration, and a pair of opposed end edges that extend between the side edges, and wherein the anchoring barb extends from one of the end edges.

17. The heart valve of claim 1, wherein the stent body is formed of a single stent having an anchoring section on an inflow end, a sinus section, and an outflow section, the sinus section being between the anchoring section and outflow section and having apertures for receiving flexible biocompatible membranes that form the occluding surfaces of the valve.

18. The heart valve of claim 17, wherein each biocompatible membrane fastens around the edge of an aperture.

19. The heart valve of claim 18, wherein the sinus apertures are generally semi-circular and the outer edge of each membrane is folded over to contact an inner surface of the stent body adjacent an edge of an aperture.

20. The heart valve of claim 17, wherein the outflow section flares outward from the sinus section.

21. The heart valve of claim 20, wherein the outflow section includes an apertured lattice, mesh or grid pattern.

22. A method of prosthetic heart valve implantation, comprising:

providing a prosthetic heart valve in a spirally-wound contracted configuration;

delivering the prosthetic heart valve in its contracted configuration through a delivery tube to a heart valve annulus; and

unfurling the prosthetic heart valve from its contracted configuration to an expanded configuration that engages the heart valve annulus.

23. The method of claim 22, wherein the prosthetic heart valve comprises a single stent body having a plurality of flexible, biocompatible membranes incorporated therein that form heart valve leaflets in the expanded configuration.

24. The method of claim 22, wherein the prosthetic heart valve comprises a two-piece stent body with a primary stent and a secondary stent, and wherein the steps of delivering and unfurling comprise delivering and unfurling the primary stent first and then delivering and unfurling the secondary stent within the primary stent.

25. The method of claim 24, further including guiding the secondary stent into unfurling position within the primary stent using one or more guidewires.

26. The method of claim 22, further including anchoring the prosthetic heart valve in its expanded configuration to the heart valve annulus.

27. The method of claim 22, wherein the native heart valve leaflets of the heart valve annulus are left in place and the step of unfurling causes the prosthetic heart valve to contact and outwardly compress the native leaflets.

28. The method of claim 22, wherein the step of unfurling further includes ensuring that the prosthetic heart valve remains generally concentric about a single axis.

29. The method of claim 22, further including the step of locking the prosthetic heart valve in its expanded configuration.