Method of securing an intralumenal frame assembly

• US 9,480,560 B2
• Filed: 01/31/2013
• Issued: 11/01/2016
• Est. Priority Date: 09/29/2009
• Status: Active Grant

• Current Assignee: Edwards Lifesciences CardiAQ LLC (Edwards Lifesciences Corporation)
• Original Assignee: Edwards Lifesciences CardiAQ LLC (Edwards Lifesciences Corporation)
• Inventors: Quadri, Arshad, Ratz, J. Brent, Michiels, Robrecht
• Primary Examiner(s): Sharma, Yashita
• Assistant Examiner(s): Preston, Rebecca
• Application Number:
  US13/755,406
• Publication Number:
  US 20130144378A1
• Time in Patent Office: 1,370 Days
• Field of Search: None
• US Class Current: 1/1
• 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 2/2439 Expansion controlled by filaments
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2210/0076 multilayered, e.g. laminated structures
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• 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 2230/0054 V-shaped
• CPC Class Codes: A61F 2250/0039 differing in diameter
• CPC Class Codes: A61F 2250/006 modular
• CPC Class Codes: A61F 2250/0069 Sealing means
• CPC Class Codes: A61F 2250/0071 breakable or frangible

Abstract

A method is disclosed of enhancing the securing of an intralumenal frame assembly to intralumenal tissue at an in situ target location. The method can comprise delivering an intralumenal frame assembly mounted on a delivery device to a treatment location. The intralumenal frame can be deployed to expand in situ so that anchors on the intralumenal frame atraumatically grasp intralumenal tissue at the target location. A radially inward force can be exerted on the frame assembly to cause the proximal and distal anchors to grasp more forcefully the intralumenal tissue.

Claims

1. A method of delivering an intralumenal frame assembly to a native mitral valve, the native mitral valve having a native mitral valve annulus, the method comprising:

delivering the intralumenal frame assembly mounted on a delivery device to the native mitral valve while the intralumenal frame assembly is in a radially compacted state, wherein a tether at least partially encircles a portion of the intralumenal frame assembly during delivery, the tether configured to radially restrain a portion of the intralumenal frame assembly, the intralumenal frame assembly comprising;

a frame having a proximal end, a distal end and a middle portion and a longitudinal axis extending between the proximal and distal ends, the frame comprising a foreshortening portion comprising foreshortening cells, the foreshortening portion configured to be located within a plane of the native mitral valve annulus when the frame is expanded at the native mitral valve; and

a plurality of proximal and distal anchors configured to atraumatically engage tissue on opposite sides of the native mitral valve annulus upon deployment of the intralumenal frame assembly; and

deploying the intralumenal frame assembly so that the foreshortening portion of the frame expands within the plane of the native mitral valve annulus while the intralumenal frame assembly remains tethered with a first end and a second end of the tether extending proximally past the proximal end of the frame;

wherein after the intralumenal frame assembly has been fully deployed at the native mitral valve, a diameter of the middle portion of the frame is greater than a diameter of the proximal end of the frame, the proximal anchors are located on a first side of the plane of the native mitral valve annulus and the distal anchors are located on a second side of the plane of the native mitral valve annulus.

2. The method of claim 1, wherein the tether fits loosely around the intralumenal frame assembly when the intralumenal frame assembly is in the radially compacted state on the delivery device.

3. The method of claim 2, wherein, upon deploying the intralumenal frame assembly, the tether radially restrains a portion of the intralumenal frame assembly.

4. The method of claim 1, wherein the tether is adjusted while the intralumenal frame assembly is located at the native mitral valve.

5. The method of claim 4, wherein the tether is adjusted to reduce a circumference of the portion of the intralumenal frame assembly.

6. The method of claim 1, further comprising engaging tissue on a left ventricular side of the native mitral valve annulus with the plurality of distal anchors.

7. The method of claim 1, further comprising removing the tether from the intralumenal frame assembly.

8. The method of claim 1, wherein the tether encircles an entire circumference of the intralumenal frame assembly.

9. The method of claim 1, wherein the tether encircles the foreshortening portion.

10. The method of claim 1, wherein the plurality of proximal anchors comprise ends which extend towards the distal end of the frame.

11. The method of claim 10, wherein the plurality of distal anchors comprise ends which extend towards the proximal end of the frame.

12. A method of delivering an intralumenal frame assembly to a native mitral valve, the native mitral valve having a native mitral valve annulus, the method comprising:

delivering the intralumenal frame assembly mounted on a delivery device to the native mitral valve while the intralumenal frame assembly is in a radially compacted state, wherein a tether at least partially encircles a portion of the intralumenal frame assembly during delivery, the tether configured to radially restrain a portion of the intralumenal frame assembly, the intralumenal frame assembly comprising;

a frame having a proximal end, a distal end and a middle portion and a longitudinal axis extending between the proximal and distal ends, the frame comprising a foreshortening portion comprising foreshortening cells, the foreshortening portion configured to be located within a plane of the native mitral valve annulus when the frame is expanded at the native mitral valve; and

a plurality of proximal and distal anchors configured to atraumatically engage tissue on opposite sides of the native mitral valve annulus upon deployment of the intralumenal frame assembly; and

deploying the intralumenal frame assembly so that the foreshortening portion of the frame expands within the plane of the native mitral valve annulus while the intralumenal frame assembly remains tethered with a first end and a second end of the tether extending proximally past the proximal end of the frame;

wherein after the intralumenal frame assembly has been fully deployed at the native mitral valve, wherein a diameter of the middle portion is greater than a diameter of the distal end, the proximal anchors are located on a first side of the plane of the native mitral valve annulus and the distal anchors are located on a second side of the plane of the native mitral valve annulus.

13. The method of claim 12, wherein the tether fits loosely around the intralumenal frame assembly when the intralumenal frame assembly is in the radially compacted state on the delivery device.

14. The method of claim 13, wherein, upon deploying the intralumenal frame assembly, the tether radially restrains a portion of the intralumenal frame assembly.

15. The method of claim 12, wherein the tether is adjusted while the intralumenal frame assembly is located at the native mitral valve.

16. The method of claim 12, further comprising removing the tether from the intralumenal frame assembly.

17. The method of claim 12, further comprising engaging tissue on a left ventricular side of the native mitral valve annulus with the plurality of proximal anchors.

18. A method of delivering an intralumenal frame assembly to a native valve, the native valve having a native valve annulus, the method comprising:

delivering an intralumenal frame assembly mounted on a delivery device to the native valve while the frame assembly is in a radially compacted state, wherein a tether is disposed about a portion of the intralumenal frame assembly, the tether having a first end and a second end extending proximally away from the intralumenal frame assembly, the tether being attached to the delivery device, the intralumenal frame assembly comprising;

a frame having a proximal end, a distal end and a middle portion and a longitudinal axis extending between the proximal and distal ends;

deploying the intralumenal frame assembly so that the frame expands in the native valve annulus to a first diameter; and

after deploying the intralumenal frame assembly to the first diameter, exerting a radially inward force on the frame using the tether via the delivery device, wherein exerting a radially inward force on the frame reduces a diameter of the frame to a second diameter less than the first diameter to reduce a radial load on the native valve annulus and mitigate risk of enlargement of the native valve annulus.

19. The method of claim 18, wherein the intralumenal frame assembly further comprises a plurality of anchors configured to atraumatically engage tissue on a side of the native valve annulus upon deployment of the intralumenal frame assembly.

20. The method of claim 18, wherein exerting the radially inward force on the frame using the tether comprises tensioning the tether around the frame.