Prosthetic heart valve configured to receive a percutaneous prosthetic heart valve implantation

• US 9,314,335 B2
• Filed: 09/19/2008
• Issued: 04/19/2016
• Est. Priority Date: 09/19/2008
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Konno, Mark
• Primary Examiner(s): Sweet, Thomas J
• Assistant Examiner(s): SCHALL, MATTHEW WAYNE
• Application Number:
  US12/234,559
• Publication Number:
  US 20100076548A1
• Time in Patent Office: 2,769 Days
• Field of Search: 623/1.15, 623/2.1, 623/2.11, 623/2.12, 623/2.17, 623/2.18, 623/2.36, 623/2.37
• 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 2/2412 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 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2442 Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• 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 2230/0034 D-shaped
• CPC Class Codes: A61F 2250/001 for adjusting a diameter
• CPC Class Codes: A61F 2250/0071 breakable or frangible

Abstract

The invention is a prosthetic heart valve, and associated methods therefore, configured to replace a native heart valve, and having a support frame configured to be reshaped into an expanded form in order to receive and/or support an expandable prosthetic heart valve therein. The prosthetic heart valve may be configured to have a generally rigid and/or expansion-resistant configuration when initially implanted to replace a native valve (or other prosthetic heart valve), but to assume a generally non-rigid and/or expanded/expandable form when subjected to an outward force such as that provided by a dilation balloon.

Claims

1. A prosthetic heart valve comprising:

a support structure having a circumference and configured to plastically transform from a generally rigid configuration to a generally non-rigid configuration when subjected to a dilation force from within the circumference of no more than 4 atmospheres, wherein the support structure comprises a plurality of segments connected in end-to-end fashion and passing about and defining the circumference, wherein adjacent segments are secured via connections which prevent separation of adjacent segments, wherein the connections comprise seams, wherein at least one of the connections is configured to separate at the corresponding seam to form a gap across which no rigid structure extends to connect the respective adjacent segments on either side of the seam when the support structure is subjected to the dilation force from within the circumference of no more than 4 atmospheres; and

a valve portion comprising a plurality of leaflets, wherein each leaflet has base edges, and the leaflets are secured around the circumference of the support structure with adjacent leaflets positioned in base-edge-to-base-edge fashion, and each leaflet base edge coincides and aligns circumferentially with a seam of the support structure;

wherein in the substantially rigid configuration the support structure defines a valve orifice and maintains the valve leaflets in proper alignment so that the valve leaflets properly open and close to permit blood flow in one direction and prevent blood flow in the opposite direction through the valve orifice.

2. The prosthetic heart valve of claim 1, wherein the connections comprise at least one of a weld, solder, or adhesive.

3. The prosthetic heart valve of claim 1, wherein the support structure is configured to break into two or more sections when subjected to the dilation force of no more than 4 atmospheres.

4. A prosthetic heart valve comprising:

a metal stent support structure having a first structure end and a second structure end and having a circumference and configured to radially expand from a first configuration to a second configuration when subjected to a dilation force of no more than 4 atmospheres, wherein the first configuration is an unexpanded configuration wherein the support structure passes 360 degrees in circular form about the prosthetic heart valve with the first structure end secured to and adjacent the second structure end, and the second configuration is a radially expanded configuration wherein the support structure passes less than 360 degrees about the prosthetic heart valve and the first structure end is separated from the second structure end by a gap with no rigid structural connection crossing the gap to join the first structure end to the second structure end; and

a valve portion having multiple leaflets;

wherein the prosthetic heart valve comprises a valve orifice having a valve orifice area and a valve inlet, wherein in the first configuration the support structure completely encircles the valve inlet and prevents enlargement of the valve orifice area, wherein when the support structure is in the first configuration the support structure maintains the valve leaflets in proper alignment to open and close to permit blood flow in one direction through the valve orifice but prevent blood flow in the opposite direction through the valve orifice, and the prosthetic heart valve is configured for the valve orifice area to be enlarged from the first configuration to the second configuration by separating the first structure end from the second structure end when the prosthetic heart valve is subjected to the dilation force of no more than 4 atmospheres.

5. The prosthetic heart valve of claim 4, wherein the prosthetic heart valve is configured for the valve orifice area to be enlarged by more than 10% when the prosthetic heart valve is subjected to the dilation force of no more than 4 atmospheres.

6. The prosthetic heart valve of claim 4, wherein the prosthetic heart valve is configured for the valve orifice area to be enlarged by more than 20% when the prosthetic heart valve is subjected to the dilation force of no more than 4 atmospheres.

7. The prosthetic heart valve of claim 4, wherein the first structure end is secured to the second structure end by at least one connection comprising adhesive, solder, or weld to define a seam in the metal support structure, wherein the connection is configured to break when the prosthetic heart valve is subjected to the dilation force of no more than 4 atmospheres.

13. The prosthetic heart valve of claim 4, wherein the support structure comprises a plurality of segments defining the circumference of the support structure, the segments also defining a lumen passing around the circumference of the support structure, wherein in the first configuration of the support structure adjacent segments are connected to each other via seams, wherein one or more of the seams is configured to rupture and thereby permit adjacent segments to separate with no rigid structures connecting adjacent segments when the prosthetic heart valve is subjected to a dilation pressure of no more than 4 atmospheres, and wherein the prosthetic heart valve further comprises:

an elastic member configured to pull at least two adjacent segments toward each other, wherein the elastic member passes through the lumen and around the circumference of the support structure.

14. The prosthetic heart valve of claim 13, wherein one or more of the seams are configured to rupture and thereby permit adjacent segments to separate when the prosthetic heart valve is subjected to a dilation pressure of no more than 1 atmosphere.

8. A method of repairing a patient'"'"'s heart function, comprising:

providing a first prosthetic heart valve having an implanted configuration, wherein the first prosthetic heart valve comprises a support frame provided in a substantially rigid configuration and comprising a circular metal support ring passing 360 degrees around the first prosthetic heart valve and having a first support ring end and a second support ring end, wherein the first support ring end is secured to and adjacent the second support ring end to form a first seam in the support ring, with the support frame configured to transform from the substantially rigid configuration to a substantially non-rigid configuration when subjected to a dilation force of no more than 4 atmospheres, wherein in the substantially non-rigid configuration the first support ring end is separated from the second support ring end by a gap and no rigid structure crosses the gap to secure the first support ring end to the second support ring end, the first prosthetic heart valve further comprising a valve portion configured, when the first prosthetic heart valve is in the implanted configuration, to open and close to permit blood flow in a first direction through the first prosthetic heart valve, and to prevent blood flow in an opposite direction through the first prosthetic heart valve; and

implanting the first prosthetic heart valve in a native heart valve annulus, wherein at the conclusion of the implantation procedure the first prosthetic heart valve remains in the native heart valve annulus in the implanted configuration with the support form in the substantially rigid configuration and with the valve portion opening and closing to permit blood flow in the first direction through the first prosthetic heart valve and to prevent blood flow in the opposite direction through the first prosthetic heart valve.

9. The method of claim 8, further comprising:

providing a second prosthetic heart valve, wherein the second prosthetic heart valve is radially expandable; and

deploying a second prosthetic heart valve within the first prosthetic heart valve.

10. The method of claim 9, wherein the second prosthetic heart valve is provided positioned on an expandable balloon, and wherein deploying the second prosthetic heart valve within the first prosthetic heart valve further comprises:

positioning the expandable balloon and second prosthetic heart valve within the first prosthetic heart valve; and

dilating the first prosthetic heart valve by inflating the expandable balloon within the first prosthetic heart valve to no more than 4 atmospheres to thereby cause the support frame of the first prosthetic heart valve to assume the substantially non-rigid configuration.

11. The method of claim 10, wherein dilating the first prosthetic heart valve comprises inflating the expandable balloon within the first prosthetic heart valve to no more than 1 atmosphere.

12. The method of claim 8, wherein the support frame of the first prosthetic heart valve is configured to transform from the substantially rigid configuration to the substantially non-rigid configuration when subjected to a dilation force of 1 atmosphere or less.