Repositioning of prosthetic heart valve and deployment

• US 9,775,707 B2
• Filed: 04/17/2015
• Issued: 10/03/2017
• Est. Priority Date: 02/01/2011
• Status: Active Grant

• Current Assignee: St. Jude Medical Cardiology Division Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: St. Jude Medical Cardiology Division Incorporated (Abbott Laboratories Incorporated)
• Inventors: Alkhatib, Yousef F., Braido, Peter N.
• Primary Examiner(s): LYNCH, ROBERT A
• Application Number:
  US14/689,212
• Publication Number:
  US 20150216659A1
• Time in Patent Office: 900 Days
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• 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 2/243 Deployment by mechanical expansion
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2472 Devices for testing
• CPC Class Codes: A61F 2/9517 handle assemblies therefor
• CPC Class Codes: A61F 2002/9534 for repositioning of stents
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0066 stapled
• 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 2230/0013 Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2230/0021 square
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/008 paraboloidal
• CPC Class Codes: A61F 2240/008 Means for testing implantable prostheses
• CPC Class Codes: A61F 2250/0039 differing in diameter

Abstract

A collapsible prosthetic heart valve includes a stent and a valve assembly. The stent has an annulus section with a relatively small cross-section, and an aortic section with a relatively large cross-section. The valve assembly, including a cuff and a plurality of leaflets, is secured to the stent in the annulus section such that the valve assembly can be entirely deployed in the native valve annulus and function as intended while at least a portion of the aortic section is held by the delivery device in a manner that allows for resheathing. The configuration of the prosthetic valve is such that the valve leaflets can fully coapt and the valve can function properly even when the stent and/or valve assembly become distorted upon deployment or use.

Claims

1. A prosthetic heart valve, comprising:

a collapsible and expandable stent extending in a longitudinal direction between a proximal end and a distal end, the stent including an annulus section adjacent the proximal end, an aortic section adjacent the distal end, a plurality of commissure features disposed in the annulus section, and a plurality of closed cells disposed continuously in annular rows around a circumference of the stent, each of the cells having a shape formed by a plurality of struts;

a collapsible and expandable valve assembly disposed within the annulus section between the proximal end of the stent and the plurality of commissure features, the valve assembly including a plurality of leaflets connected to the plurality of commissure features; and

a cuff disposed in the annulus section, the cuff covering the entirety of each of the cells in a proximal annular row of cells and the entirety of selected ones of the cells in an annular row of cells adjacent to the proximal annular row, the selected cells being positioned between one of the commissure features and the cells in the proximal annular row of cells, the cuff having a distal edge including a zig-zag pattern of peaks pointing toward the proximal end of the stent alternating with peaks pointing toward the distal end of the stent, the peaks pointing toward the distal end of the stent including a first group of peaks extending a first distance toward the distal end of the stent alternating with a second group of peaks extending a second distance toward the distal end of the stent, the second distance being less than the first distance.

2. The prosthetic heart valve as claimed in claim 1, wherein the struts at the proximal end of the stent form a zig-zag pattern of peaks pointing toward the proximal end of the stent alternating with peaks pointing toward the distal end of the stent, and the cuff has a proximal edge including a zig-zag pattern of peaks pointing toward the proximal end of the stent alternating with peaks pointing toward the distal end of the stent, the cuff being disposed in the annulus section so that the proximal edge of the cuff is aligned with the struts at the proximal end of the stent.

3. The prosthetic heart valve as claimed in claim 1, wherein each of the peaks in the first group of peaks has a free end aligned in a radial direction of the stent with one of the commissure features.

4. The prosthetic heart valve as claimed in claim 1, wherein each of the commissure features is disposed between a cell in one annular row and another cell in an adjacent annular row.

5. A prosthetic heart valve, comprising:

a collapsible and expandable stent extending in a longitudinal direction between a proximal end and a distal end, the stent including an annulus section adjacent the proximal end, an aortic section adjacent the distal end, a transition section between the aortic section and the annulus section, and a plurality of closed cells disposed continuously in annular rows around a circumference of the stent;

a plurality of commissure features disposed at a juncture between the annulus section and the transition section, each of the commissure features being disposed at an intersection of four of the closed cells;

a collapsible and expandable valve assembly disposed within the annulus section between the proximal end of the stent and the plurality of commissure features, the valve assembly including a plurality of leaflets connected to the plurality of commissure features; and

a cuff disposed in the annulus section, the cuff having a distal edge including a zig-zag pattern of peaks pointing toward the proximal end of the stent alternating with peaks pointing toward the distal end of the stent, the peaks pointing toward the distal end of the stent including a first group of peaks extending a first distance toward the distal end of the stent and a second group of peaks extending a second distance toward the distal end of the stent, the second distance being less than the first distance.

6. The prosthetic heart valve as claimed in claim 5, wherein the cuff has a scalloped proximal edge.

7. The prosthetic heart valve as claimed in claim 5, wherein the four cells include two cells in one of the annular rows, a cell in an annular row adjacent one side of the one annular row and a cell in an annular row adjacent an opposite side of the one annular row.

8. The prosthetic heart valve as claimed in claim 5, wherein the stent has a length from the proximal end to the distal end, and the plurality of commissure features are positioned at a distance from the distal end, the distance being about ⅔

of the length.

9. The prosthetic heart valve as claimed in claim 5, wherein the peaks in the first group of peaks alternate with the peaks in the second group of peaks.

10. The prosthetic heart valve as claimed in claim 5, wherein each of the peaks in the first group of peaks has a free end aligned in a radial direction of the stent with one of the commissure features.

11. A method of deploying a prosthetic heart valve at a target site, the method comprising:

introducing a delivery device to the target site, the delivery device housing a prosthetic heart valve in a collapsed condition and having an outer sheath surrounding the prosthetic heart valve, the prosthetic heart valve including a collapsible and expandable stent having a proximal end, a distal end, an annulus section adjacent the proximal end, an aortic section adjacent the distal end, a plurality of cells having a closed shape disposed continuously in annular rows around a circumference of the stent from the proximal end to the distal end, each of the cells being formed by a plurality of struts and having a first end pointing toward the distal end of the stent and a second end pointing toward the proximal end of the stent, the first end of each cell in a group of cells in the annulus section being connected directly to the second end of an adjacent cell, the stent including a plurality of commissure features disposed in the annulus section, each of the commissure features being disposed entirely between the first end of one cell in one annular row and the second end of another cell in an adjacent annular row, and a collapsible and expandable valve assembly disposed entirely within the annulus section between the proximal end of the stent and the plurality of commissure features;

withdrawing the sheath a first distance to partially deploy the prosthetic heart valve at the target site, the prosthetic heart valve being deployed from the proximal end of the stent toward the distal end of the stent such that the valve assembly is fully deployed at the first distance and can function as intended while the distal end of the stent is held within the sheath of the delivery device;

resheathing the prosthetic heart valve; and

withdrawing the sheath the first distance to again partially deploy the prosthetic heart valve at the target site, the prosthetic heart valve being deployed from the proximal end of the stent toward the distal end of the stent such that the valve assembly is fully deployed at the first distance and can function as intended while the distal end of the stent is held within the sheath of the delivery device.

12. The method of claim 11, further comprising withdrawing the sheath so as to fully deploy the prosthetic heart valve.

13. A method of testing the operability of a prosthetic heart valve at a target site, the method comprising:

introducing a delivery device to the target site, the delivery device housing a prosthetic heart valve in a collapsed condition and having an outer sheath surrounding the prosthetic heart valve, the prosthetic heart valve including a collapsible and expandable stent having a proximal end, a distal end, an annulus section adjacent the proximal end, an aortic section adjacent the distal end, a plurality of cells having a closed shape disposed continuously in annular rows around a circumference of the stent from the proximal end to the distal end, each of the cells being formed by a plurality of struts and having a first end pointing toward the distal end of the stent and a second end pointing toward the proximal end of the stent, the first end of each cell in a group of cells in the annulus section being connected directly to the second end of an adjacent cell, the stent including a plurality of commissure features disposed in the annulus section, each of the commissure features being disposed entirely between the first end of one cell in one annular row and the second end of another cell in an adjacent annular row, and a collapsible and expandable valve assembly disposed entirely within the annulus section between the proximal end of the stent and the plurality of commissure features;

withdrawing the sheath a first distance to partially deploy the prosthetic heart valve at the target site, the prosthetic heart valve being deployed from the proximal end of the stent toward the distal end of the stent such that the valve assembly is fully deployed at the first distance and can function as intended while the distal end of the stent is held within the sheath of the delivery device; and

assessing valve function when the prosthetic heart valve is partially deployed and resheathing the prosthetic heart valve.

14. The method of claim 13, wherein introducing the delivery device to the target site includes introducing the delivery device to a target site in vitro.

15. The method of claim 13, wherein introducing the delivery device to the target site includes introducing the delivery device to a target site in a mammal.

16. The method of claim 13, wherein introducing the delivery device to the target site includes introducing the delivery device to a target site in a human patient.

17. A system, comprising:

a delivery device having a valve-receiving compartment and a sheath slidable relative to the valve-receiving compartment; and

a prosthetic heart valve disposed in the valve-receiving compartment, the prosthetic heart valve including a collapsible and expandable stent having a proximal end, a distal end, an annulus section adjacent the proximal end, an aortic section adjacent the distal end, and a plurality of cells having a closed shape disposed continuously in annular rows around a circumference of the stent from the proximal end to the distal end, each of the cells being formed by a plurality of struts and having a first end pointing toward the distal end of the stent and a second end pointing toward the proximal end of the stent, the first end of each cell in a group of cells in the annulus section being connected directly to the second end of an adjacent cell, the annulus section having a first expanded cross-section and the aortic section having a second expanded cross-section larger than the first expanded cross-section, the stent including a plurality of commissure features disposed in the annulus section, each of the commissure features being disposed entirely between the first end of one cell in one annular row and the second end of another cell in an adjacent annular row, and a collapsible and expandable valve assembly disposed entirely within the annulus section between the proximal end of the stent and the plurality of commissure features, the valve assembly including a plurality of leaflets connected to the plurality of commissure features,

the sheath being withdrawn from around the prosthetic valve to expose the commissure features, wherein the valve assembly is free to operate as intended in a portion of the stent not retained by the sheath.

18. A system, comprising:

a delivery device having a valve-receiving compartment and a sheath slidable relative to the valve-receiving compartment; and

a prosthetic heart valve disposed in the valve-receiving compartment, the prosthetic heart valve including a collapsible and expandable stent having a proximal end, a distal end, an annulus section adjacent the proximal end, an aortic section adjacent the distal end, and a plurality of cells having a closed shape disposed circumferentially in annular rows around a circumference of the stent from the proximal end to the distal end, each of the cells being formed by a plurality of struts and having a first end pointing toward the distal end of the stent and a second end pointing toward the proximal end of the stent, the first end of each cell in a group of cells in the annulus section being connected directly to the second end of an adjacent cell, the annulus section having a first expanded cross-section and the aortic section having a second expanded cross-section larger than the first expanded cross-section, the stent including a plurality of commissure features disposed in the annulus section, each of the commissure features being disposed entirely between the first end of one cell in one annular row and the second end of another cell in an adjacent annular row, and a collapsible and expandable valve assembly disposed entirely within the annulus section between the proximal end of the stent and the plurality of commissure features, the valve assembly including a plurality of leaflets connected to the plurality of commissure features,

the sheath being movable from a first configuration in which the sheath is partially withdrawn from around the prosthetic valve to expose the commissure features so that the valve assembly is free to operate as intended in a portion of the stent not retained by the sheath, and a second configuration in which the sheath substantially completely covers the stent and the valve assembly is incapable of operating as intended.