Rolled minimally invasive heart valves

• US 7,276,084 B2
• Filed: 09/02/2003
• Issued: 10/02/2007
• Est. Priority Date: 03/23/2001
• Status: Expired due to Term

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Walsh, Brandon G., Pease, Matthew L., Yang, Jibin
• Primary Examiner(s): McDermott; Corrine
• Assistant Examiner(s): Miller; Cheryl
• Application Number:
  US10/653,843
• Publication Number:
  US 20060173537A1
• Time in Patent Office: 1,491 Days
• Field of Search: 623/1.16, 623/1.17, 623/1.22, 623/1.24, 623/1.26, 623/1.44, 623 21- 219, 623/900
• US Class Current: 623/2.14
• 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 to annulus of a patient'"'"'s heart valve, comprising:

a spirally-wound sheet-like stent body defining a flow axis and an inflow end and an outflow end spaced along the axis; and

a plurality of separate biocompatible membranes attached to the stent body along curvilinear cusps and commissures on the stent body that are generally axially extending toward the outflow end, with a free edge of each membrane extending between the commissures.

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 having a generally tubular anchoring section on the inflow end, a sinus section, and a generally tubular outflow section, the sinus section being between the anchoring section and the outflow section and the biocompatible membranes being attached to the stent body in the sinus section.

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

6. The heart valve of claim 1, wherein the stent body has a plurality of sinus apertures having edges defined by the cusps and commissures and an outer edge of each biocompatible membrane fastens around th edge of a sinus aperture.

7. The heart valve of claim 6, wherein the outer edge of each membrane is folded over to contact an inner surface of the stent body adjacent the edge of the associated sinus aperture.

8. 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 a first spirally-wound configuration to a second, spirally-unwound configuration.

9. The heart valve of claim 8, wherein the stent body defines a pair of opposed side edges that generally mate in the second 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.

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

11. The heart valve of claim 10, wherein the lockout structure both prevents further expansion of the stent body and contraction from a spirally-unwound configuration of the stent body.

12. The heart valve of claim 1, further including at least one anchoring barb extending radially outward from the stent body n a spirally-unwound configuration of the stent body.

13. The heart valve of claim 12, wherein the stent body defines a pair of opposed side edges that generally mate in the spirally-unwound configuration of the stent body, and a pair of opposed end edges that extend between the side edges and wherein the at least one anchoring barb extends from one of the end edges.

14. The heart valve of claim 1, wherein the plurality of separate biocompatible membranes are made of bovine pericardium.

15. The heart valve of claim 1, wherein the stent body is made of a nickel-titanium alloy.

16. The heart valve of claim 1, wherein the stent body converts between a first, spirally-wound configuration to a second, spirally-unwound configuration and includes a ratchet type of lockout structure to enable size adjustment of the spirally-unwound configuration.

33. The heart valve of claim 1, wherein the stent body includes a ratchet type of lockout structure to enable size adjustment of the second, expanded configuration.

17. A prosthetic heart valve suitable for minimally invasive delivery to an annulus of a patient s heart valve, 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 overlaps 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 the patient'"'"'s heart valve annulus; and

a plurality of flexible, biological tissue membranes attached to the stent body to form heart valve leaflets in the second configuration, an outer edge of each leaflet being attached to the stent body along a curvilinear path defined by generally axially-extending commissures on either side of a curvilinear cusp, the commissures of each leaflet converging with commissures of adjacent leaflets, each leaflet having a free edge remaining unattached to permit the leaflets to billow inward upon blood flow in one direction along the axis such that the free edges of adjacent leaflets coapt with each other and occlude blood flow in the one direction.

18. The heart valve of claim 17, wherein the stent body comprises a primary stent coupled to a secondary stent that at least partially fits within the primary stent.

19. The heart valve of claim 18, wherein the membranes are incorporated into the secondary stent.

20. The heart valve of claim 17, wherein the stent body is formed of a single stent.

21. The heart valve of claim 17, wherein the stent body is formed of a single stent having a generally tubular anchoring section on an inflow end, a sinus section, and a generally tubular outflow section, the sinus section being between the anchoring section and the outflow section and the flexible, biological tissue membranes being attached to the stent body in the sinus section.

22. The heart valve of claim 17, wherein the stent body has a plurality of sinus apertures and the outer edge of each biological tissue membrane fastens around the edge of an aperture.

23. The heart valve of claim 22, 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.

24. The heart valve of claim 17, further including at least one guide on the stent body 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.

25. The heart valve of claim 24, wherein the stent body defines a pair of opposed side edges that generally mate in the second, expanded configuration, and 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.

26. The heart valve of claim 24, 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 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.

27. The heart valve of claim 17, 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.

28. The heart valve of claim 27, wherein the lockout structure both prevents further expansion of the stent body and contraction from the second, expanded configuration.

29. The heart valve of claim 17, further including at least one anchoring barb extending radially outward from the stent body in the second, expanded configuration.

30. The heart valve of claim 29, 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 at least one anchoring barb extends from one of the end edges.

31. The heart valve of claim 17, wherein the biological tissue is bovine pericardium.

32. The heart valve of claim 17, wherein the stent body is made of a nickel-titanium alloy.