Low profile heart valve and delivery system

• US 10,206,774 B2
• Filed: 01/26/2016
• Issued: 02/19/2019
• Est. Priority Date: 12/23/2003
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Salahieh, Amr, Brandt, Brian D., Morejohn, Dwight P., Haug, Ulrich R., Dueri, Jean-Pierre, Valencia, Hans F., Geshlider, Robert A., Krolik, Jeff A.
• Primary Examiner(s): Dukert, Brian
• Application Number:
  US15/006,227
• Publication Number:
  US 20160135951A1
• Time in Patent Office: 1,120 Days
• 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 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2439 Expansion controlled by filaments
• CPC Class Codes: A61F 2002/9528 for retrieval of stents
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• 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 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0065 toroidal, e.g. ring-shaped, doughnut-shaped
• CPC Class Codes: A61F 2230/0078 hyperboloidal
• CPC Class Codes: A61F 2250/006 modular

Abstract

Apparatus for endovascularly replacing a patient'"'"'s heart valve, including: a delivery catheter having a diameter of 21 french or less; an expandable anchor disposed within the delivery catheter; and a replacement valve disposed within the delivery catheter. The invention also includes a method for endovascularly replacing a heart valve of a patient. In some embodiments the method includes the steps of: inserting a catheter having a diameter no more than 21 french into the patient; endovascularly delivering a replacement valve and an expandable anchor to a vicinity of the heart valve through the catheter; and deploying the anchor and the replacement valve.

Claims

1. A replacement heart valve, comprising:

an expandable anchor configured for delivery to a vicinity of a patient'"'"'s heart valve, the expandable anchor having a body section defining a lumen extending therethrough from an upstream end to a downstream end;

a plurality of valve leaflets coupled to the expandable anchor; and

a leaflet engagement structure coupled to the downstream end of the expandable anchor and extending toward the upstream end of the expandable anchor;

wherein the expandable anchor further includes a skirt section coupled to the upstream end of the expandable anchor;

wherein the skirt section extends radially outward from the body section when the replacement heart valve is in a deployed configuration.

2. The replacement heart valve of claim 1, wherein the replacement heart valve is configured to sandwich a native valve leaflet of the patient'"'"'s heart valve between the expandable anchor and the leaflet engagement structure when the replacement heart valve is in a deployed configuration.

3. The replacement heart valve of claim 1, wherein the leaflet engagement structure is configured to engage a native valve leaflet of the patient'"'"'s heart valve, thereby providing positive registration of the expandable anchor relative to the native valve leaflet.

5. The replacement heart valve of claim 1, wherein the leaflet engagement structure includes a plurality of tissue-engaging elements.

6. The replacement heart valve of claim 1, wherein at least a portion of the leaflet engagement structure is disposed radially outward of the body section.

7. The replacement heart valve of claim 6, wherein a majority of the leaflet engagement structure is disposed radially outward of the body section.

8. The replacement heart valve of claim 1, wherein the expandable anchor is configured to shift between a collapsed configuration and an expanded configuration.

9. The replacement valve of claim 8, wherein the expandable anchor is configured to reversibly shift between the collapsed configuration and a partially-expanded configuration.

10. The replacement heart valve of claim 1, further including a delivery tool comprising:

a delivery sheath adapted to transport the expandable anchor therein; and

a plurality of actuation elements;

wherein the plurality of actuation elements is releasably coupled to the expandable anchor.

11. The replacement heart valve of claim 10, wherein the plurality of actuation elements is adapted to apply an axially directed force on the expandable anchor to deploy the expandable anchor after the expandable anchor is outside of the delivery sheath.

12. The replacement heart valve of claim 1, wherein the plurality of valve leaflets is configured to move between an open configuration and a closed configuration.

13. The replacement heart valve of claim 1, further including a seal disposed along an outwardly-facing surface of the expandable anchor.

14. The replacement heart valve of claim 1, wherein the plurality of valve leaflets is disposed within the lumen of the body section.

4. A replacement heart valve, comprising:

an expandable anchor configured for delivery to a vicinity of a patient'"'"'s heart valve, the expandable anchor having a body section defining a lumen extending therethrough from an upstream end to a downstream end;

a plurality of valve leaflets coupled to the expandable anchor; and

a leaflet engagement structure coupled to the downstream end of the expandable anchor and extending toward the upstream end of the expandable anchor;

wherein the expandable anchor further includes a skirt section coupled to the upstream end of the expandable anchor;

wherein the skirt section is configured to seal against a wall on an upstream side of the patient'"'"'s heart valve.