Collapsible-expandable prosthetic heart valves with structures for clamping native tissue

• US 10,426,604 B2
• Filed: 04/16/2015
• Issued: 10/01/2019
• Est. Priority Date: 09/28/2007
• Status: Active Grant

• Current Assignee: St. Jude Medical (Abbott Laboratories Incorporated)
• Original Assignee: St. Jude Medical (Abbott Laboratories Incorporated)
• Inventors: Braido, Peter N.
• Primary Examiner(s): Mathew, Seema
• Application Number:
  US14/688,357
• Publication Number:
  US 20150216657A1
• Time in Patent Office: 1,629 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 2/2433 using balloon catheter
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0078 hyperboloidal

Abstract

A prosthetic heart valve is designed to be circumferentially collapsible for less invasive delivery into the patient. At the implant site the valve re-expands to a larger circumferential size, i.e., the size that it has for operation as a replacement for one of the patient'"'"'s native heart valves. The valve includes structures that, at the implant site, extend radially outwardly to engage tissue structures above and below the native heart valve annulus. These radially outwardly extending structures clamp the native tissue between them and thereby help to anchor the prosthetic valve at the desired location in the patient.

Claims

1. A prosthetic heart valve, comprising

a unitary stent having a length in a longitudinal direction between an inflow end and an outflow end, the inflow end of the stent having an inflow edge, the stent being formed of metal and including a plurality of closed perimeter, diamond-shaped cells, the stent having a collapsed condition and an expanded condition, the inflow end of the stent having a first circumference in the expanded condition of the stent and the outflow end of the stent having a second circumference larger than the first circumference in the expanded condition of the stent;

an expandable and collapsible valve element mounted within the stent and connected to the stent by sutures;

a skirt connected to the stent and extending continuously from a skirt inflow end that extends in a circumferential direction around the inflow edge of the stent to a skirt outflow end, the skirt having a length in the longitudinal direction that is less than the length of the stent so that the skirt outflow end is positioned at a spaced distance from the outflow end of the stent; and

a sealing ring disposed in the circumferential direction around the inflow edge of the stent and around an outside of the skirt, the sealing ring extending in the longitudinal direction from a lower end located at a first distance from the outflow end of the stent to an upper end located at a second distance from the outflow end of the stent, the second distance being less than the first distance, the upper end being farther from the outflow end of the stent than the spaced distance, the sealing ring being positioned on the stent to impede paravalvular leakage, the stent, the valve element, the skirt and the sealing ring collectively forming a valve assembly that is collapsible and expandable along the entire length of the stent.

2. The prosthetic heart valve as claimed in claim 1, wherein the sealing ring comprises a material selected from the group consisting of tissue, fabric and a polymer.

3. The prosthetic heart valve as claimed in claim 1, wherein the skirt is disposed around the outside of the stent.

4. The prosthetic heart valve as claimed in claim 1, wherein the stent is self-expanding.

5. The prosthetic heart valve as claimed in claim 1, wherein the stent is balloon expandable.

6. The prosthetic heart valve as claimed in claim 1, wherein the inflow end of the stent in the expanded condition is sized and shaped for implantation in the native aortic valve annulus of a patient.

7. The prosthetic heart valve as claimed in claim 1, wherein the valve element has a length in the longitudinal direction that is less than a length of the stent from the inflow end to the outflow end.

8. The prosthetic heart valve as claimed in claim 1, wherein the stent includes a plurality of closed cells disposed around a circumference of the stent, each of the closed cells having an area, the area of each of the closed cells at the outflow end of the stent being greater than the area of each of the closed cells at the inflow end of the stent.

9. The prosthetic heart valve as claimed in claim 1, wherein the skirt includes a polymer.

10. The prosthetic heart valve as claimed in claim 9, wherein the valve element is formed from tissue.

11. A prosthetic heart valve, comprising

a unitary stent having a length in a longitudinal direction between an inflow end and an outflow end, the inflow end of the stent having an inflow edge, the stent including a plurality of closed perimeter, diamond-shaped cells, the stent having a collapsed condition and an expanded condition;

a collapsible and expandable valve element mounted within the stent and connected to the stent by sutures; and

a skirt connected to the stent and extending continuously from a skirt inflow end that extends in a circumferential direction around the inflow edge of the stent to a skirt outflow end, the skirt having a length in the longitudinal direction that is less than the length of the stent so that the skirt outflow end is positioned at a spaced distance from the outflow end of the stent, the skirt having a chamber disposed in the circumferential direction around the inflow edge of the stent and extra sealing capacity to prevent paravalvular leakage, the stent, the valve element and the skirt collectively forming a valve assembly that is collapsible and expandable along the entire length of the stent.

12. The prosthetic heart valve as claimed in claim 11, wherein the chamber is disposed around an outside of the stent.

13. The prosthetic heart valve as claimed in claim 11, wherein the inflow end of the stent has a first circumference in an expanded condition of the stent and the outflow end of the stent has a second circumference larger than the first circumference in the expanded condition of the stent.