Two-part expandable heart valve

• US 7,947,072 B2
• Filed: 05/16/2007
• Issued: 05/24/2011
• Est. Priority Date: 03/23/2001
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Yang, Jibin, Walsh, Brandon G., Pease, Matthew L.
• Primary Examiner(s): McDermott; Corrine
• Assistant Examiner(s): MILLER, CHERYL L
• Application Number:
  US11/749,722
• Publication Number:
  US 20070255398A1
• Time in Patent Office: 1,469 Days
• Field of Search: 623/1.24, 623/1.26, 623 21- 24, 623/900, 623/1.17, 623/1.22
• US Class Current: 623/1.26
• 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 two-part prosthetic heart valve, comprising:

an expandable tubular primary stent sized to contact a heart valve annulus in an expanded state and having a first plurality of discrete mating features, wherein the tubular primary stent comprises a 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 from within;

an expandable secondary stent configured to be coupled to the primary stent and having a second plurality of discrete mating features that mate with the first plurality of discrete mating features on the primary stent;

a plurality of valve leaflets attached to the secondary stent for occluding blood flow in one direction; and

a plurality of guidewires each threaded through the secondary stent and then coupled to the primary stent for ensuring proper rotational alignment during advancement of the secondary stent toward the primary stent so that the first and second pluralities of discrete mating features on both the primary stent and secondary stent engage each other.

2. The two-part prosthetic heart valve of claim 1, wherein the expandable secondary stent has a tubular mesh portion and a scalloped wireform portion, wherein the valve leaflets attach to the wireform portion.

3. The two-part prosthetic heart valve of claim 2, wherein the tubular mesh portion is configured to fit within and couple to the tubular primary stent while the wireform portion extends out of an outflow end of the primary stent.

4. The two-part prosthetic heart valve of claim 1, wherein the second plurality of discrete mating features on the secondary stent comprise coupling tabs and the first plurality of discrete mating features on the primary stent comprise coupling apertures.

5. The two-part prosthetic heart valve of claim 1, wherein the valve leaflets include separate leaflets cut from bovine pericardium and the secondary stent has a scalloped wireform portion on an outflow end thereof, the wireform portion having alternating arcuate cusps and upstanding commissures that support the separate leaflets.

6. The two-part prosthetic heart valve of claim 1, wherein the expandable secondary stent comprises a 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 tubular primary stent from within.

7. The two-part prosthetic heart valve of claim 1, wherein the tubular primary stent is balloon expandable.

8. The two-part prosthetic heart valve of claim 1, wherein the secondary stent is balloon expandable.

9. A two-part prosthetic heart valve, comprising:

an expandable tubular primary stent sized to contact a heart valve annulus in an expanded state and having a first plurality of discrete mating features;

an expandable secondary stent configured to be coupled to the primary stent and having a second plurality of discrete mating features that mate with the first plurality of discrete mating features on the primary stent, wherein the expandable secondary stent comprises a 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 tubular primary stent from within;

a plurality of valve leaflets attached to the secondary stent for occluding blood flow in one direction; and

a plurality of guidewires each threaded through the secondary stent and then coupled to the primary stent for ensuring proper rotational alignment during advancement of the secondary stent toward the primary stent so that the first and second pluralities of discrete mating features on both the primary stent and secondary stent engage each other.

10. A method of delivering a two-part prosthetic heart valve, comprising:

providing an expandable tubular primary stent sized to contact a heart valve annulus in an expanded state and having a first plurality of discrete mating features;

providing an expandable secondary stent configured to be coupled to the primary stent and having a second plurality of discrete mating features that mate with the first plurality of discrete mating features on the primary stent to couple the secondary stent thereto, wherein the expandable secondary stent comprises a 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 tubular primary stent from within;

providing a plurality of guidewires each threaded through the secondary stent and then coupled to the primary stent to ensure proper rotational alignment between the secondary stent and the primary stent;

expanding the primary stent within the heart valve annulus; and

advancing the secondary stent along the guidewires so that the first and second pluralities of discrete mating features on both the primary stent and secondary stent engage each other and the secondary stent couples to the primary stent.

11. A method of delivering a two-part prosthetic heart valve, comprising:

providing an expandable tubular primary stent sized to contact a heart valve annulus in an expanded state and having a first plurality of discrete mating features, wherein the tubular primary stent comprises a 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 from within;

providing an expandable secondary stent configured to be coupled to the primary stent and having a second plurality of discrete mating features that mate with the first plurality of discrete mating features on the primary stent to couple the secondary stent thereto;

providing a plurality of guidewires each threaded through the secondary stent and then coupled to the primary stent to ensure proper rotational alignment between the secondary stent and the primary stent;

expanding the primary stent within the heart valve annulus; and

advancing the secondary stent along the guidewires so that the first and second pluralities of discrete mating features on both the primary stent and secondary stent engage each other and the secondary stent couples to the primary stent.

12. The method of claim 11, wherein the secondary stent has a tubular mesh portion and a scalloped wireform portion and wherein a valve member is attached to the wireform portion for occluding blood flow in one direction.

13. The method of claim 12, wherein the tubular mesh portion is configured to couple to the tubular primary stent while the wireform portion extends out of an outflow end of the primary stent.

14. The method of claim 12, wherein the valve member includes separate leaflets cut from bovine pericardium and the secondary stent has a scalloped wireform portion on an outflow end thereof, the wireform portion having alternating arcuate cusps and upstanding commissures that support the separate leaflets.

15. The method of claim 11, wherein the second plurality of discrete mating features on the secondary stent comprise coupling tabs and the first plurality of discrete mating features on the primary stent comprise coupling apertures.

16. The prosthetic heart valve delivery method of claim 11 wherein the expandable secondary stent comprises a 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 tubular primary stent from within.

17. The prosthetic heart valve delivery method of claim 11, wherein the tubular primary stent is balloon expandable.

18. The prosthetic heart valve delivery method of claim 11, wherein the secondary stent is balloon-expandable.