PERCUTANEOUS HEART VALVE

• US 20170020695A1
• Filed: 10/10/2016
• Published: 01/26/2017
• 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
• Granted Patent: US 9,974,669 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• 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 percutaneous heart valve for deployment within a body cavity is described. The percutaneous heart valve includes an expandable frame having a plurality of cells adapted for allowing the frame to expand and collapse. A one-way valve is positioned within the expandable frame. The frame includes a proximal anchoring portion and a distal anchoring portion. The distal anchoring portion includes a plurality of distal anchors, each distal anchor having at least a portion positioned radially outwardly from the frame and extending in a direction that is substantially parallel with a longitudinal axis. The distal anchors preferably bend radially outwardly before bending to extend toward the proximal anchoring portion. Radial expansion of the frame causes the proximal and distal anchoring portions to move closer together for capturing body tissue therebetween, thereby anchoring the percutaneous heart valve to the body tissue.

Claims

1. A percutaneous heart valve configured to be deployed within a body cavity having an opening surrounded by surrounding body tissue, 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;

a valve seated inside the expandable frame;

a proximal anchoring portion, wherein when the frame is in an expanded configuration, the proximal anchoring portion extends at least partially distally; and

a distal anchoring portion comprising a plurality of distal anchors, wherein when the frame is in an expanded configuration;

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 distal anchors bends radially outwardly along a first portion before bending to extend toward the proximal anchoring portion along a second portion; 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; and

wherein the frame is configured such that radial expansion of the frame within the opening causes the proximal anchoring portion and the distal anchors to draw closer with the surrounding body tissue positioned between the proximal anchoring portion and the distal anchors.

2. The heart valve of claim 1, wherein:

when the frame is in an expanded configuration within the opening, the proximal anchoring portion is configured to be positioned on a first side of the surrounding body tissue and the distal anchors are configured to be 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 are configured to 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 heart valve of claim 1, wherein, when the frame is in an expanded configuration within the opening:

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

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

4. The heart valve 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 an expanded configuration.

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

6. The heart valve of claim 1, wherein the cells, the proximal anchoring portion and the distal anchoring portion are formed by laser cutting.

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

8. The heart valve of claim 7, wherein, when the frame is in an 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 heart valve of claim 1, wherein, when the frame is in an expanded configuration, the 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 distal anchors each having a first portion attached to the distal ends of the cells and a second portion extending more proximally than the first portion, the second portion extending generally parallel to the longitudinal axis.

10. The heart valve of claim 1, wherein a distalmost portion of the proximal anchoring portion and the proximalmost portions of the distal anchors are sized to pinch the first and second sides of the surrounding body tissue together when the frame is in the expanded configuration.

11. A percutaneous heart valve configured to be deployed within a body cavity having an opening surrounded by surrounding body tissue, 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;

a valve seated inside the expandable frame;

a proximal anchoring portion, wherein when the frame is in an expanded configuration, the proximal anchoring portion extends at least partially distally; 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, wherein when the frame is in an expanded configuration;

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; and

wherein the frame is configured such that radial expansion of the frame within the opening causes the proximal anchoring portion and the distal anchors to draw closer with the surrounding body tissue positioned between the proximal anchoring portion and the distal anchors.

12. The heart valve of claim 11, wherein, when the frame is in an expanded configuration, at least a portion of the distal anchors between the attached end and the bend extends radially outward.

13. The heart valve of claim 12, wherein, when the frame is in an expanded configuration, the 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.

14. The heart valve of claim 11, wherein:

when the frame is in an expanded configuration within the opening, the proximal anchoring portion is configured to be positioned on a first side of the surrounding body tissue and the distal anchors are configured to be 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 are configured to 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.

15. The heart valve of claim 11, wherein, when the frame is in an expanded configuration within the opening:

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

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

16. The heart valve of claim 11, wherein the proximal anchoring portion comprises a plurality of circumferentially spaced anchoring tips positioned radially outward from the frame when the frame is in an expanded configuration.

17. The heart valve of claim 16, wherein when the frame is in an expanded configuration within the opening, the anchoring tips of the proximal anchoring portion extend at least partially distally toward the first side of the surrounding body tissue.

18. A percutaneous heart valve, comprising:

a self-expanding cylindrical frame having a collapsed configuration and an expanded configuration, the frame comprising a plurality of opposing prongs, the prongs adapted to substantially conform to a shape of the cylindrical frame when the frame is in the collapsed condition; and

a valve seated inside the expandable frame;

wherein the opposing prongs are adapted to bend outwardly and move closer together as the frame expands for engaging surrounding body tissue.

19. The heart valve of claim 18, wherein the opposing prongs are arranged in facing pairs.

20. The heart valve of claim 19, wherein the opposing prongs bend outwardly away from the cylindrical frame and then bend to extend in a direction substantially parallel with a longitudinal axis of the cylindrical frame when in the expanded configuration.