VALVE ASSEMBLY FOR CRIMP PROFILE

• US 20160030172A1
• Filed: 10/14/2015
• Published: 02/04/2016
• Est. Priority Date: 06/29/2012
• Status: Active Grant

• Current Assignee: St. Jude Medical Cardiology Division Incorporated (Abbott Laboratories)
• Original Assignee: St. Jude Medical Cardiology Division Incorporated (Abbott Laboratories)
• Inventors: Braido, Peter N., Coyle, Daniel, Johnson, Mary, Schraut, Julia A., Buesseler, Ryan, Daly, Jacob John
• Granted Patent: US 10,470,880 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2415 Manufacturing methods
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2002/9505 having retaining means other than an outer sleeve, e.g. male-female connector between stent and instrument
• CPC Class Codes: A61F 2002/9511 the retaining means being filaments or wires
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: Y10T 29/49405 Valve or choke making
• CPC Class Codes: Y10T 29/49925 Inward deformation of aperture or hollow body wall
• CPC Class Codes: Y10T 29/49936 Surface interlocking
• CPC Class Codes: Y10T 29/4994 Radially expanding internal tube

Abstract

A method of assembling a prosthetic heart valve includes providing a collapsible and expandable stent having an annulus section and an aortic section. The annulus section has a first diameter in a relaxed condition and a second diameter less than the first diameter in a collapsed condition. A constraint is applied to the stent to constrain the annulus section to a predetermined diameter between the first and second diameters. Applying a cuff and/or a plurality of leaflets to the stent in the constrained condition enables less material to be used. The resultant prosthetic valve is therefore able to be collapsed to a smaller diameter for introduction into a patient.

Claims

1. (canceled)

2. A method of assembling a prosthetic heart valve, comprising:

providing a collapsible and expandable stent having an annulus section, the annulus section having a first annulus diameter in a relaxed condition and a second annulus diameter less than the first annulus diameter in a collapsed condition;

applying an annular constraint around a circumference of the stent to constrain the annulus section to a predetermined annulus diameter between the first annulus diameter and the second annulus diameter;

assembling at least one of a cuff or a plurality of leaflets to the constrained annulus section to form a prosthetic heart valve; and

removing the constraint from the stent prior to implantation of the prosthetic heart valve within a native valve annulus.

3. The method of claim 2, wherein the stent further includes an aortic section having a first aortic diameter in the relaxed condition and a second aortic diameter less than the first aortic diameter in the collapsed condition, and the step of applying the constraint constrains the aortic section to a predetermined aortic diameter between the first aortic diameter and the second aortic diameter.

4. The method of claim 3, wherein the constraint comprises a first suture tied to the annulus section of the stent to constrain the diameter of the annulus section to the predetermined annulus diameter and a second suture tied to the aortic section of the stent to constrain the diameter of the aortic section to the predetermined aortic diameter.

5. The method of claim 2, wherein the predetermined annulus diameter is between about 85% and about 95% of the first annulus diameter.

6. The method of claim 2, wherein the constraint comprises at least one drawstring to constrain the diameter of the annulus section.

7. The method of claim 6, wherein the at least one drawstring comprises a first suture tied to the annulus section of the stent to constrain the diameter of the annulus section to the predetermined annulus diameter.

8. The method of claim 7, wherein the removing step includes cutting the first suture to release the annulus section to an unconstrained annulus diameter between the predetermined annulus diameter and the first annulus diameter.

9. The method of claim 2, wherein the constraint comprises at least one ring disposed about a circumference of the stent to constrain the diameter of the stent.

10. The method of claim 2, wherein the constraint comprises a first ring disposed about the annulus section of the stent and a second ring disposed about the aortic section of the stent.

11. The method of claim 10, wherein the first ring and the second ring are coupled together by a helical portion.

12. The method of claim 11, further comprising rotating the constraint with respect to the stent to facilitate the assembling step.

13. A constraint for assembling a prosthetic heart valve including a collapsible and expandable stent having an annulus section, the annulus section having a first annulus diameter in a relaxed condition and a second annulus diameter less than the first annulus diameter in a collapsed condition, the constraint comprising:

a cylindrical body having a proximal opening, a distal opening, and a lumen defined between the proximal opening and the distal opening and sized to constrain the annulus section to a predetermined annulus diameter between the first annulus diameter and the second annulus diameter, the body further comprising at least one window configured and arranged to permit assembly of the prosthetic heart valve therethrough.

14. The constraint of claim 13, wherein the at least one window comprises three triangular windows evenly spaced about the circumference of the constraint.

15. The constraint of claim 13, wherein the constraint further comprises a cone portion at the distal opening.

16. The constraint of claim 13, further comprising cutouts in the body spaced to facilitate assembly of the prosthetic heart valve.

17. The constraint of claim 13, wherein the constraint further comprises at least two rings and a plurality of struts coupled to the at least two rings, the plurality of struts defining the at least one window.

18. The constraint of claim 17, wherein the constraint comprises three rings.

19. A method of assembling a prosthetic heart valve, comprising:

providing a collapsible and expandable stent having an annulus section and an aortic section, the annulus section having a first annulus diameter in a relaxed condition and second annulus diameter less than the first annulus diameter in a collapsed condition;

cooling the stent to a temperature below a predetermined temperature at which the diameter of the annulus section decreases to a predetermined diameter between the first and second diameters; and

assembling at least one of a cuff or a plurality of leaflets to the cooled stent to form a prosthetic heart valve.

20. The method of claim 19, wherein the step of cooling the stent comprises placing the stent within a cooled air box.

21. The method of claim 19, wherein the predetermined temperature is below the austenite transition temperature.