Method of securing a prosthesis

• US 9,433,514 B2
• Filed: 01/09/2012
• Issued: 09/06/2016
• 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): Sweet, Thomas J
• Assistant Examiner(s): WOLF, MEGAN YARNALL
• Application Number:
  US13/346,593
• Publication Number:
  US 20120179239A1
• Time in Patent Office: 1,702 Days
• Field of Search: 623/1.15, 623/1.16, 623/1.36
• 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 method of securing a prosthesis atraumatically to body tissue can include one or more of the following steps. A prosthesis can be delivered into a patient. The prosthesis may include an expandable frame. The frame can be expanded within a body cavity of the patient. Expansion of the frame can causes respective ends of both proximal prongs and distal prongs to draw closer together to grasp native tissue between the respective ends of the proximal prongs and distal prongs.

Claims

1. A method of securing a prosthesis to a native heart valve, comprising:

delivering a prosthesis into a patient, the prosthesis comprising;

an expandable frame extending along a longitudinal axis between a proximal end and a distal end, the expandable frame comprising a first and second row of cells;

a plurality of spaced-apart proximal anchors connected to the frame at the first row of cells;

a plurality of spaced-apart distal anchors connected to the frame at the second row of cells; and

a replacement valve seated within the frame; and

expanding the frame within the native heart valve of the patient with the replacement valve seated within the frame, wherein expansion of the frame causes the proximal anchors and the distal anchors to draw closer together with body tissue positioned between the proximal anchors and the distal anchors, wherein when the frame is in an expanded configuration;

each distal anchor of the plurality of distal anchors extends proximally to a proximal most portion of the distal anchor that is positioned radially outward from the frame;

the proximal most portions of the distal anchors extend in a direction that is more parallel with the longitudinal axis than with a transverse axis perpendicular to the longitudinal axis;

the proximal most portions of the distal anchors are spaced apart from the proximal anchors by less than two cell lengths; and

at least one of the distal anchors bends radially outwardly before bending to extend longitudinally toward the plurality of spaced-apart proximal anchors.

2. The method of claim 1, wherein when the frame is in an expanded configuration, each proximal anchor of the plurality of proximal anchors extends distally to a distal most portion of the proximal anchor that is positioned radially outward from the frame.

3. The method of claim 2, wherein when the frame is in an expanded configuration, each proximal anchor extends distally in a direction that is more parallel with the longitudinal axis than with a transverse axis perpendicular to the longitudinal axis.

4. The method of claim 2, wherein the proximal most portions of the distal anchors and the distal most portions of the proximal anchors are spaced apart by less than one cell length when the frame is in the expanded configuration.

5. The method of claim 1, wherein the distal anchors are connected to the frame only at locations on the frame distal to the proximal most portions of the distal anchors.

6. The method of claim 1, wherein distal most portions of the proximal anchors and proximal most portions of the distal anchors are generally collinearly aligned.

7. The method of claim 1, wherein expanding the frame comprises expanding the frame by self-expansion.

8. The method of claim 1, wherein expanding the frame further comprises foreshortening at least a portion of the frame.

9. The method of claim 1, wherein each distal anchor of the plurality of distal anchors is connected to the frame in a distal portion of a cell, and wherein with respect to such cells having distal anchors, expanding the frame causes the distal portion of such cells to extend further radially outward than a proximal portion of such cells.

10. The method of claim 1, wherein after expanding the frame within the native heart valve of the patient, body tissue spaced radially outward from the frame and positioned between the proximal anchors and the distal anchors is pinched between the proximal and distal anchors.

11. The method of claim 1, wherein the proximal anchors and the distal anchors are atraumatic.

12. The method of claim 1, wherein at least one of the distal anchors extends from a distal portion of a cell.

13. The method of claim 12, wherein the at least one distal anchor extends from a corner of the distal portion of the cell.

14. A method of securing a prosthesis to a native heart valve, comprising:

delivering a prosthesis into a patient, the prosthesis comprising;

an expandable frame extending along a longitudinal axis between a proximal end and a distal end, the expandable frame comprising a plurality of cells;

a proximal anchoring portion connected to the frame;

a plurality of spaced-apart distal anchors connected to the frame; and

a replacement valve seated within the frame; and

expanding the frame within the native heart valve of the patient with the replacement valve seated within the frame, wherein expansion of the frame causes the proximal anchoring portion and the distal anchors to draw closer together with body tissue positioned between the proximal anchoring portion and the distal anchors, wherein when the frame is in an expanded configuration;

each distal anchor of the plurality of distal anchors extends proximally to a proximal most portion of the distal anchor that is positioned radially outward from the frame;

the proximal most portions of the distal anchors extend in a direction that is more parallel with the longitudinal axis than with a transverse axis perpendicular to the longitudinal axis;

the proximal most portions of the distal anchors are spaced apart from the proximal anchoring portion by less than two cell lengths; and

each distal anchor of the plurality of distal anchors is connected to the frame within a cell; and

with respect to such cells having distal anchors, expanding the frame causes a distal portion of such cells to extend further radially outward than a proximal portion of such cells and wherein each distal anchor extends only from the distal portion of such cells in a direction generally parallel with the longitudinal axis toward the proximal anchoring portion, and

wherein each such cell comprises only one anchor.

15. The method of claim 14, wherein the distal anchors are atraumatic.

16. The method of claim 14, wherein after expanding the frame within the native heart valve of the patient, body tissue spaced radially outward from the frame and positioned between the proximal anchoring portion and the distal anchors is pinched between the proximal anchoring portion and the distal anchors.

17. The method of claim 14, wherein each distal anchor of the plurality of distal anchors is generally equally spaced between sides of corresponding cells.

18. The method of claim 14, wherein at least one distal anchor extends from a corner of the distal portion of a corresponding cell.

19. The method of claim 18, wherein the at least one distal anchor extends from a distal most corner of the corresponding cell.

20. The method of claim 14, wherein at least one of the distal anchors bends radially outwardly before bending to extend longitudinally toward the proximal anchoring portion.