Percutaneous heart valve

• US 10,456,277 B2
• Filed: 05/18/2018
• Issued: 10/29/2019
• Est. Priority Date: 11/10/2005
• Status: Active Grant

• Current Assignee: Edwards Lifesciences CardiAQ LLC (Edwards Lifesciences Corporation)
• Original Assignee: Edwards Lifesciences CardiAQ LLC (Edwards Lifesciences Corporation)
• Inventors: Quadri, Arshad
• Primary Examiner(s): Wolf, Megan Y
• Application Number:
  US15/984,027
• Publication Number:
  US 20180263795A1
• Time in Patent Office: 529 Days
• Field of Search: None
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2/915 with bands having a meander structure, adjacent bands being connected to each other
• CPC Class Codes: A61F 2002/8483 Barbs
• CPC Class Codes: A61F 2002/8486 provided on at least one of the ends
• CPC Class Codes: A61F 2002/91541 Adjacent bands are arranged out of phase
• CPC Class Codes: A61F 2002/91558 connected peak to peak
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2230/0013 Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2230/0054 V-shaped

Abstract

A method of delivering a percutaneous heart valve is disclosed. The percutaneous heart valve includes an expandable frame having a plurality of cells and a valve seated inside the expandable frame. The heart valve also includes a proximal anchoring portion and a distal anchoring portion having a plurality of distal anchors. After expansion, the proximal anchoring portion extends distally and a portion of each distal anchor extends proximally. A portion of each distal anchor is positioned radially outwardly from the frame and extends in a direction that is substantially parallel with the longitudinal axis. Proximal portions of the distal anchors are preferably spaced apart by less than two cell lengths from a distal portion of the proximal anchoring portion. During deployment, radial expansion of the frame draws the proximal anchoring portion and the distal anchors into closer proximity with body tissue positioned therebetween.

Claims

1. A method of deploying a percutaneous heart valve into a body cavity having an opening surrounded by surrounding body tissue, the method comprising:

delivering a percutaneous heart valve to the body cavity in a collapsed configuration, the percutaneous heart valve comprising;

an expandable frame comprising a proximal end and a distal end and a longitudinal axis extending therethrough, the expandable frame comprising a plurality of cells configured to permit the frame to radially expand and collapse between the collapsed configuration and an expanded configuration;

a valve seated inside the expandable frame;

a proximal anchoring portion; and

a distal anchoring portion comprising a plurality of distal anchors; and

radially expanding the expandable frame to the expanded configuration within the opening, wherein, when the percutaneous heart valve is in the expanded configuration;

the proximal anchoring portion extends at least partially distally;

at least a portion of each distal anchor extends proximally to a proximalmost portion of the distal anchor positioned radially outward from the frame, the proximalmost portions extending in a direction that is more parallel with the longitudinal axis than with a transverse axis perpendicular to the longitudinal axis;

at least one of the plurality of distal anchors bends radially outwardly before bending to extend toward the proximal anchoring portion; and

the proximalmost portions of the plurality of distal anchors are spaced apart by less than two cell lengths from a distalmost portion of the proximal anchoring portion;

wherein radially expanding the expandable frame draws the proximal anchoring portion and the plurality of distal anchors closer together with the surrounding body tissue positioned between the proximal anchoring portion and the plurality of distal anchors.

2. The method of claim 1, wherein:

when the frame is in the expanded configuration within the opening, the proximal anchoring portion is positioned on a first side of the surrounding body tissue and the distal anchors are positioned on a second side of the surrounding body tissue opposite the first side; and

upon movement of the frame within the opening in a proximal direction, the distal anchors longitudinally engage the second side of the surrounding body tissue with a proximally-facing surface of the proximalmost portions of the distal anchors which are positioned radially outward from the frame.

3. The method of claim 1, wherein, when the frame is in the expanded configuration within the opening:

the proximal anchoring portion is positioned on a first side of the surrounding body tissue and the distal anchors are positioned on a second side of the surrounding body tissue opposite the first side; and

the proximalmost portions of the distal anchors engage the second side of the surrounding body tissue at a location radially outward of the opening.

4. The method of claim 1, wherein the proximal anchoring portion comprises a plurality of circumferentially spaced anchoring tips positioned radially outward from the frame when the frame is in the expanded configuration.

5. The method of claim 4, wherein when the frame is in the expanded configuration within the opening, the plurality of circumferentially spaced anchoring tips of the proximal anchoring portion extend at least partially distally toward a first side of the surrounding body tissue.

6. The method of claim 1, further comprising forming the cells, the proximal anchoring portion, and the distal anchoring portion by laser cutting.

7. The method of claim 1, wherein each of the plurality of distal anchors are connected to distal ends of cells of the frame.

8. The method of claim 7, wherein, when the frame is in the expanded configuration, the distal ends of each cell to which the distal anchors are attached are in a position spaced radially outward relative to a portion of the frame located proximal to the distal ends of each cell to which the distal anchors are attached.

9. The method of claim 7, wherein, when the frame is in the expanded configuration, the plurality of distal anchors bend radially outwardly to a position spaced radially outward relative to a portion of the frame located proximal to the distal ends of the cells to which the distal anchors are attached, the at least one distal anchor being attached to the distal end of the cell, at least a portion of the at least one distal anchor extending generally parallel to the longitudinal axis.

10. The method of claim 1, wherein a distalmost portion of the proximal anchoring portion and the proximalmost portions of the plurality of distal anchors are sized to pinch first and second sides of the surrounding body tissue together after the radially expanding.

11. The method of claim 1, wherein the body cavity comprises a native aortic valve.

12. A method of deploying a percutaneous heart valve within a body cavity having an opening surrounded by surrounding body tissue, the method comprising:

delivering a percutaneous heart valve to the body cavity in a collapsed configuration, the percutaneous heart valve comprising;

an expandable frame comprising a proximal end and a distal end and a longitudinal axis extending therethrough, the expandable frame comprising a plurality of cells configured to permit the frame to radially expand and collapse for deployment within the opening of the body cavity between the collapsed configuration and an expanded configuration;

a valve seated inside the expandable frame;

a proximal anchoring portion; and

a distal anchoring portion comprising a plurality of distal anchors, each distal anchor comprising an attached end connected to the frame, a free end, and a bend between the attached end and the free end; and

radially expanding the expandable frame to the expanded configuration within the opening, wherein, when the percutaneous heart valve is in the expanded configuration;

the proximal anchoring portion extends at least partially distally;

at least a portion of each distal anchor extends proximally to a proximalmost portion of the distal anchor positioned radially outward from the frame, the proximalmost portions extending in a direction that is more parallel with the longitudinal axis than with a transverse axis perpendicular to the longitudinal axis; and

the proximalmost portions of the distal anchors are spaced apart by less than two cell lengths from a distalmost portion of the proximal anchoring portion;

wherein the radially expanding the expandable frame draws the proximal anchoring portion and the distal anchors closer together with the surrounding body tissue positioned between the proximal anchoring portion and the plurality of distal anchors.

13. The method of claim 12, wherein, when the frame is in the expanded configuration, at least a portion of the distal anchors between the attached end and the bend extends radially outward.

14. The method of claim 13, wherein, when the frame is in the expanded configuration, each bend orients a portion of the distal anchor immediately after the bend in a direction more parallel with the longitudinal axis than a portion of the distal anchor immediately before the bend.

15. The method of claim 12, wherein:

when the frame is in the expanded configuration within the opening, the proximal anchoring portion is positioned on a first side of the surrounding body tissue and the distal anchors are positioned on a second side of the surrounding body tissue opposite the first side; and

upon movement of the frame within the opening in a proximal direction, the plurality of distal anchors longitudinally engage the second side of the surrounding body tissue with a proximally-facing surface of the proximalmost portions of the distal anchors which are positioned radially outward from the frame.

16. The method of claim 12, wherein, when the frame is in the expanded configuration within the opening:

the proximal anchoring portion is positioned on a first side of the surrounding body tissue and the plurality of distal anchors are positioned on a second side of the surrounding body tissue opposite the first side; and

the proximalmost portions of the plurality of distal anchors engage the second side of the surrounding body tissue at a location radially outward of the opening.

17. The method of claim 12, wherein the proximal anchoring portion comprises a plurality of circumferentially spaced anchoring tips positioned radially outward from the frame when the frame is in the expanded configuration.

18. The method of claim 17, wherein when the frame is in the expanded configuration within the opening, the plurality of circumferentially spaced anchoring tips of the proximal anchoring portion extend at least partially distally toward a first side of the surrounding body tissue.

19. The method of claim 12, wherein the body cavity comprises a native aortic valve.