Collapsible prosthetic heart valves

• US 10,292,813 B2
• Filed: 12/07/2016
• Issued: 05/21/2019
• Est. Priority Date: 09/26/2007
• Status: Active Grant

• Current Assignee: St. Jude Medical (Abbott Laboratories Incorporated)
• Original Assignee: St. Jude Medical (Abbott Laboratories Incorporated)
• Inventors: Braido, Peter N., McCarthy, Andrea L., Figueiredo, Rubem L., Schraut, Julia
• Primary Examiner(s): Gherbi, Suzette J
• Application Number:
  US15/371,384
• Publication Number:
  US 20170079789A1
• Time in Patent Office: 895 Days
• Field of Search: 623 21- 219
• CPC Class Codes: A61F 2/2403 with pivoting rigid closure members check valves with hinged closure members in general F16K15/03
• 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 2/2415 Manufacturing methods
• 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 2/89 the wire-like elements comprising two or more adjacent rings flexibly connected by separate members
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• 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 2230/0006 circular
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0069 cylindrical

Abstract

Prosthetic heart valves, which are collapsible to a relatively small circumferential size for less invasive delivery into a patient and which then re-expand to operating size at an implant site in the patient, include a collapsible/expandable stent-like supporting structure and various components of flexible, sheet-like material that are attached to the supporting structure. For example, these sheet-like other components may include prosthetic valve leaflets, layers of buffering material, cuff material, etc. Improved structures and techniques are provided for securing such other components to the stent-like supporting structure of the valve.

Claims

1. A prosthetic heart valve, comprising:

an annularly collapsible and re-expandable supporting structure extending from an inflow end having a bottom edge to an outflow end, the supporting structure having a flared section at the inflow end and another section adjacent the flared section;

a plurality of leaflets disposed inside the supporting structure and operative to allow blood flow from the inflow end to the outflow end, but to substantially block blood flow from the outflow end to the inflow end; and

a structure of material having a first portion disposed on a luminal surface of the supporting structure adjacent the inflow end and a second portion disposed on an abluminal surface of the supporting structure, the second portion covering at least a portion of the flared section and having a first end relatively far from the outflow end of the supporting structure and a second end closer to the outflow end of the supporting structure than the first end, the first portion being joined to the second portion at the bottom edge and the second portion being joined to the supporting structure at the second end.

2. The prosthetic heart valve as claimed in claim 1, wherein the first portion and the second portion of the structure of material are formed from the same material.

3. The prosthetic heart valve as claimed in claim 1, wherein the first portion of the structure of material is formed from biological tissue.

4. The prosthetic heart valve as claimed in claim 3, wherein the first portion of the structure of material is formed from pericardial tissue.

5. The prosthetic heart valve as claimed in claim 1, wherein the supporting structure is self-expanding.

6. The prosthetic heart valve as claimed in claim 1, wherein the second portion of the structure of material covers all of the flared section and a portion of the another section.

7. A prosthetic heart valve, comprising:

an annularly collapsible and re-expandable supporting structure extending from an inflow end to an outflow end, the supporting structure having a flared section at the inflow end;

a plurality of leaflets disposed inside the supporting structure and operative to allow blood flow from the inflow end to the outflow end, but to substantially block blood flow from the outflow end to the inflow end, each of the leaflets including a pair of end members, a free edge and a secured line portion extending between the end members and opposite the free edge, a pair of the end members from each adjacent pair of the leaflets being joined to one another and to the supporting structure; and

a structure of material having a first portion disposed on a luminal surface of the supporting structure adjacent the inflow end and a second portion disposed on an abluminal surface of the supporting structure, the second portion covering at least a portion of the flared section and being formed from a polyester fabric.

8. A prosthetic heart valve, comprising:

an annularly collapsible and re-expandable supporting structure extending from an inflow end to an outflow end, the supporting structure having a flared section at the inflow end and another section adjacent the flared section;

a plurality of leaflets disposed inside the supporting structure and operative to allow blood flow from the inflow end to the outflow end, but to substantially block blood flow from the outflow end to the inflow end; and

a structure of material having a first portion disposed on a luminal surface of the supporting structure adjacent the inflow end and a second portion disposed on an abluminal surface of the supporting structure, the second portion covering at least a portion of the flared section, the second portion having a first end relatively far from the outflow end of the supporting structure and a second end closer to the outflow end of the supporting structure than the first end, the second portion being joined to the supporting structure at the second end.

9. A prosthetic heart valve, comprising:

an annularly collapsible and re-expandable supporting structure extending from an inflow end to an outflow end, the supporting structure having a flared section at the inflow end and another section adjacent the flared section;

a plurality of leaflets disposed inside the supporting structure and operative to allow blood flow from the inflow end to the outflow end, but to substantially block blood flow from the outflow end to the inflow end; and

a structure of material having a first portion disposed on a luminal surface of the supporting structure adjacent the inflow end and a second portion disposed on an abluminal surface of the supporting structure, the second portion covering at least a portion of the flared section, the second portion having a first end relatively far from the outflow end of the supporting structure and a second end closer to the outflow end of the supporting structure than the first end, the second portion being joined to the first portion at the second end.

10. A prosthetic heart valve, comprising:

an annularly collapsible and re-expandable supporting structure extending from an inflow end to an outflow end, the supporting structure having a flared section at the inflow end and another section adjacent the flared section;

a plurality of leaflets disposed inside the supporting structure and operative to allow blood flow from the inflow end to the outflow end, but to substantially block blood flow from the outflow end to the inflow end, each of the leaflets including a pair of end members, a free edge and a secured line portion extending between the pair of end members and opposite the free edge, a pair of the end members from each adjacent pair of the leaflets being joined to one another and to the supporting structure; and

a structure of material having a first portion disposed on a luminal surface of the supporting structure adjacent the inflow end and a second portion disposed on an abluminal surface of the supporting structure, the second portion covering at least a portion of the flared section.

11. A prosthetic heart valve, comprising:

an annularly collapsible and re-expandable supporting structure extending from an inflow end having a bottom edge to an outflow end, the supporting structure having a flared section at the inflow end and another section adjacent the flared section;

a plurality of leaflets disposed inside the supporting structure and operative to allow blood flow from the inflow end to the outflow end, but to substantially block blood flow from the outflow end to the inflow end; and

a structure of material having a first portion disposed on a luminal surface of the supporting structure adjacent the inflow end and a second portion disposed on an abluminal surface of the supporting structure, the second portion covering at least a portion of the flared section and having a first end relatively far from the outflow end of the supporting structure and a second end closer to the outflow end of the supporting structure than the first end, the first portion being joined to the second portion at the bottom edge and at the second end.

12. A prosthetic heart valve, comprising:

an annularly collapsible and re-expandable supporting structure extending from an inflow end having a bottom edge to an outflow end, the supporting structure having a flared section at the inflow end and another section adjacent the flared section;

a plurality of leaflets disposed inside the supporting structure and operative to allow blood flow from the inflow end to the outflow end, but to substantially block blood flow from the outflow end to the inflow end, each of the leaflets including a pair of end members, a free edge and a secured line portion extending between the pair of end members and opposite the free edge, a pair of the end members from each adjacent pair of the leaflets being joined to one another and to the supporting structure; and

a structure of material having a first portion disposed on a luminal surface of the supporting structure adjacent the inflow end and a second portion disposed on an abluminal surface of the supporting structure, the second portion covering at least a portion of the flared section, the first portion being joined to the second portion at the bottom edge.