Repositioning of prosthetic heart valve and deployment

• US 9,039,759 B2
• Filed: 08/23/2011
• Issued: 05/26/2015
• Est. Priority Date: 08/24/2010
• 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 Nicholas
• Primary Examiner(s): Houston, Elizabeth
• Assistant Examiner(s): LYNCH, ROBERT A
• Application Number:
  US13/215,901
• Publication Number:
  US 20120053681A1
• Time in Patent Office: 1,372 Days
• Field of Search: 623/1.26, 623/2.1, 623/2.11, 623/2.17, 623/2.18, 623/2.19, 623/2.36, 623/2.38, 623/900, 623/904
• US Class Current: 623/2.11
• 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 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 closed cells disposed continuously in annular rows around a circumference of the stent from the proximal end to the distal end, each of the cells having a diamond shape formed by a plurality of struts, 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 points disposed in the annulus section, each of the commissure points 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 points, the valve assembly including a plurality of leaflets connected to the plurality of commissure points;

the plurality of commissure points being spaced from the distal end of the stent by a selected distance such that the prosthetic valve can be partially deployed from a delivery device at a target site by withdrawing a portion of a sheath of the delivery device from around the prosthetic valve, and the valve assembly can function as intended while the distal end of the stent is held within the sheath of the delivery device in a manner that enables resheathing.

2. The prosthetic heart valve of claim 1, wherein the selected distance is about two-thirds of the length of the stent from the proximal end to the distal end.

3. The prosthetic heart valve of claim 1, wherein the plurality of leaflets have an open condition in which the leaflets are spaced apart from one another to define a flow passageway through the stent, and a closed condition in which the leaflets coapt to occlude the flow passageway, the leaflets being disposed completely within the annulus section in both the open and closed conditions.

4. The prosthetic heart valve of claim 1, wherein the valve assembly further comprises a cuff disposed only in the annulus section.

5. The prosthetic heart valve of claim 4, wherein the cuff is disposed on a lumenal surface of the annulus section.

6. The prosthetic heart valve of claim 4, wherein the cuff is disposed on an ablumenal surface of the annulus section.

7. The prosthetic heart valve of claim 4, wherein the plurality of leaflets are coupled to the stent.

8. The prosthetic heart valve of claim 1, wherein the plurality of leaflets includes three leaflets.

9. The prosthetic heart valve of claim 1, wherein the plurality of leaflets includes two leaflets.

10. The prosthetic heart valve of claim 1, further comprising sutures connecting the plurality of leaflets to the plurality of commissure points.

11. A prosthetic heart valve, comprising:

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 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 from the proximal end to the distal end, each of the cells having a diamond shape formed by a plurality of struts, 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, the aortic section having a second expanded cross-section larger than the first expanded cross-section, and the transition section having an expanded cross-section which transitions from the first expanded cross-section to the second expanded cross-section;

the stent including a plurality of commissure points disposed at a juncture between the annulus section and the transition section, each of the commissure points 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 points, the valve assembly including a plurality of leaflets connected to the plurality of commissure points;

the plurality of commissure points being spaced from the distal end of the stent by a selected distance such that the prosthetic valve can be partially deployed from a delivery device at a target site by withdrawing a portion of a sheath of the delivery device from around the prosthetic valve, and the valve assembly can function as intended while the distal end of the stent is held within the sheath of the delivery device in a manner that enables resheathing.

12. A prosthetic heart valve, comprising:

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 closed cells disposed continuously in annular rows around a circumference of the stent from the proximal end to the distal end, each of the cells having a diamond shape formed by a plurality of struts, 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 an unconstrained shape and the aortic section having a second expanded cross-section larger than the first expanded cross-section;

the stent including a plurality of commissure points disposed in the annulus section, each of the commissure points 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 points, the valve assembly including a plurality of leaflets connected to the plurality of commissure points, the plurality of leaflets having an open condition in which the leaflets are spread apart from one another to define a flow passageway through the stent, and a closed condition in which the leaflets form coaptation sections to occlude the flow passageway, the coaptation sections occluding the flow passageway both when the annulus section has the unconstrained shape and when the annulus section is distorted from the unconstrained shape.

13. The prosthetic heart valve of claim 12, wherein, in the closed condition, the coaptation sections are oriented substantially parallel to a longitudinal axis of the stent.

14. The prosthetic heart valve of claim 13, wherein each coaptation section has a length in a direction from a free-edge of a leaflet toward the stent, the length being between about 1 mm and about 5 mm.

15. The prosthetic heart valve of claim 13, wherein, in the closed condition, each of the plurality of leaflets forms a belly contour before converging at the coaptation section.

16. The prosthetic heart valve of claim 13, wherein, in the closed condition, each of the plurality of leaflets forms a flat belly before converging at the coaptation section.

17. 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 closed cells disposed continuously in annular rows around a circumference of the stent from the proximal end to the distal end, each of the cells having a diamond shape formed by a plurality of struts, 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 points disposed in the annulus section, each of the commissure points 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 points;

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

further withdrawing the sheath so as to fully deploy the prosthetic heart valve.

18. The method of claim 17, wherein partially deploying the prosthetic heart valve includes withdrawing the sheath to uncover only the annulus section of the heart valve and fully deploying the heart valve includes withdrawing the sheath to uncover both the annulus section and the aortic section of the heart valve.

19. The method of claim 17, wherein the valve assembly includes a plurality of leaflets connected to the plurality of commissure points, the plurality of leaflets having an open condition in which the leaflets are spaced apart from one another to define a flow passageway through the stent, and a closed condition in which the leaflets coapt to occlude the flow passageway and the plurality of leaflets can fully coapt when the heart valve is partially deployed at the target site.

20. The method of claim 19, wherein the plurality of leaflets are capable of forming coaptation sections to occlude the flow passageway, the coaptation sections occluding the flow passageway both when the annulus section has an unconstrained shape and when the annulus section is distorted from the unconstrained shape.

21. 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 closed cells disposed continuously in annular rows around a circumference of the stent from the proximal end to the distal end, each of the cells having a diamond shape formed by a plurality of struts, 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 points disposed in the annulus section, each of the commissure points 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 points;

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.

22. The method of claim 21, further comprising withdrawing the sheath so as to fully deploy the prosthetic heart valve.

23. 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 closed cells disposed continuously in annular rows around a circumference of the stent from the proximal end to the distal end, each of the cells having a diamond shape formed by a plurality of struts, 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 points disposed in the annulus section, each of the commissure points 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 points;

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.

24. The method of claim 23, wherein introducing the delivery device to the target site includes introducing the delivery device to a target site in vitro.

25. The method of claim 23, wherein introducing the delivery device to the target site includes introducing the delivery device to a target site in a mammal.

26. The method of claim 23, wherein introducing the delivery device to the target site includes introducing the delivery device to a target site in a human patient.

27. 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 closed cells disposed continuously in annular rows around a circumference of the stent from the proximal end to the distal end, each of the cells having a diamond shape formed by a plurality of struts, 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 points disposed in the annulus section, each of the commissure points 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 points, the valve assembly including a plurality of leaflets connected to the plurality of commissure points,

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

28. 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 closed cells disposed circumferentially in annular rows around a circumference of the stent from the proximal end to the distal end, each of the cells having a diamond shape formed by a plurality of struts, 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 points disposed in the annulus section, each of the commissure points 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 points, the valve assembly including a plurality of leaflets connected to the plurality of commissure points,

the sheath being movable from a first configuration in which the sheath is partially withdrawn from around the prosthetic valve to expose the commissure points 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.