Prosthesis for atraumatically grasping intralumenal tissue and methods of delivery

• US 9,730,791 B2
• Filed: 03/05/2014
• Issued: 08/15/2017
• Est. Priority Date: 03/14/2013
• Status: Active Grant

• Current Assignee: Edwards Lifesciences CardiAQ LLC (Edwards Lifesciences Corporation)
• Original Assignee: Edwards Lifesciences CardiAQ LLC (Edwards Lifesciences Corporation)
• Inventors: Ratz, J. Brent, Pesce, Luca, Quadri, Arshad
• Primary Examiner(s): SWEET, THOMAS
• Assistant Examiner(s): Schutte, Wade P
• Application Number:
  US14/197,590
• Publication Number:
  US 20140277390A1
• Time in Patent Office: 1,259 Days
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2250/0039 differing in diameter
• CPC Class Codes: A61F 2250/006 modular
• CPC Class Codes: A61F 2250/0069 Sealing means

Abstract

A prosthesis can comprise an expandable frame, a plurality of distal anchors and a plurality of proximal anchors. The anchors can extend outwardly from the frame. The frame can be configured to radially expand and contract for deployment within a body cavity. The frame and anchors can have one of many different shapes and configurations. For example, when the frame is in an expanded configuration, the proximal anchors can extend a significant distance away from the exterior of the frame, such as a length equal to or greater than about one half the diameter of the frame. As another example, the anchors can have looped ends.

Claims

1. A prosthesis configured to grasp intralumenal tissue when deployed within a body cavity, the prosthesis comprising:

an expandable frame portion comprising a proximal end and a distal end and a longitudinal axis extending therethrough, the expandable frame portion comprising a plurality of foreshortening cells configured to collapse radially for delivery and to expand radially upon deployment, the expandable frame portion being configured to longitudinally foreshorten upon radial expansion;

a plurality of proximal anchors extending from the expandable frame portion and expandable from a collapsed configuration to an expanded configuration, wherein in the expanded configuration, each proximal anchor extends proximally away from the proximal end of the expandable frame portion and then turns to extend radially outwardly from the expandable frame portion;

a plurality of distal anchors extending from the expandable frame portion and expandable from a collapsed configuration to an expanded configuration, wherein in the expanded configuration, each distal anchor extends distally away from the distal end of the expandable frame portion and then turns to extend proximally, each distal anchor extending to an end positioned radially outward from the expandable frame portion; and

a skirt comprising;

a distal portion extending along an exterior of the expandable frame portion and the distal anchors; and

a proximal portion sized to extend along at least a portion of the plurality of proximal anchors, wherein an end of the proximal portion is positioned further radially outward from the longitudinal axis than the ends of the distal anchors wherein the entirety of the proximal portion of the skirt is spaced distally from the proximal end of the expandable frame portion;

wherein the proximal anchors and distal anchors are separated by the plurality of foreshortening cells such that the proximal anchors and distal anchors are configured to be drawn closer together along the longitudinal axis when the expandable frame portion foreshortens; and

wherein each distal anchor extends distally from the expandable frame portion along a first segment, the first segment being substantially parallel with the longitudinal axis.

2. The prosthesis of claim 1, wherein at least some of the proximal anchors and/or distal anchors comprise looped ends.

3. The prosthesis of claim 1, wherein all of the plurality of proximal anchors and the plurality of distal anchors comprise looped ends.

4. The prosthesis of claim 2, wherein at least some of the anchors comprising looped ends are connected to the expandable frame portion at a first base and a second base spaced apart from each other.

5. The prosthesis of claim 2, wherein at least some of the anchors comprising looped ends are connected to the expandable frame portion by a single strut.

6. The prosthesis of claim 1, wherein the expandable frame portion, the plurality of proximal anchors and the plurality of distal anchors are formed from a single piece of material.

7. The prosthesis of claim 1, wherein the ends of at least some of the proximal anchors and/or distal anchors are substantially parallel with the longitudinal axis when the expandable frame portion is at least partially expanded and the proximal and distal anchors are in their expanded configurations.

8. The prosthesis of claim 1, wherein the ends of at least some of the proximal anchors are substantially perpendicular with the longitudinal axis when the expandable frame portion is at least partially expanded and the proximal anchors are in their expanded configurations.

9. A replacement mitral valve comprising the prosthesis of claim 1, wherein when the expandable frame portion is in an expanded configuration, the expandable frame portion is positionable within a native mitral valve annulus such that:

the distal anchors are positionable within the ventricle and have portions that extend generally proximally toward a ventricular side of the native mitral valve annulus.

10. The replacement mitral valve of claim 9, wherein the distal anchors are positionable within the ventricle and extend proximally to ends spaced distally from the native mitral valve annulus.

11. The replacement mitral valve of claim 9, wherein the distal anchors are positionable within the ventricle and extend proximally to ends that engage the native mitral valve annulus.

12. The replacement mitral valve of claim 9, wherein the proximal anchors atraumatically engage tissue on an atrial side of the native mitral valve annulus.

13. The prosthesis of claim 1, wherein each proximal anchor turns to extends distally after extending proximally from the proximal end of the expandable frame portion.

14. The prosthesis of claim 1, wherein each proximal anchor comprises a cell which extends proximally away from the proximal end of the expandable frame portion and then turns to extend radially outwardly from the expandable frame portion.

15. The prosthesis of claim 1, wherein in the expanded configuration, each of the plurality of distal anchors is bent to extend radially outwardly away from the first segment along a second segment and is then bent to extend proximally along a third segment.

16. The prosthesis of claim 1, wherein adjacent proximal anchors extend from a same corner of a foreshortening cell.

17. The prosthesis of claim 1, wherein the expandable frame portion comprises a first row of foreshortening cells and a second row of foreshortening cells, wherein the one or more foreshortening cells of the first row comprise a shape which is different from a shape of one or more of the foreshortening cells of the second row.

18. The prosthesis of claim 1, wherein the proximal anchors are each connected to the expandable frame portion at a first base and a second base spaced apart from each other and wherein a longitudinal strut extends between at least one of the proximal anchors.

19. The prosthesis of claim 1, wherein the plurality of distal anchors are approximately equally spaced around a periphery of the expandable frame portion.

20. A prosthesis configured to grasp intralumenal tissue when deployed within a native mitral valve, the prosthesis comprising:

an expandable frame portion comprising a proximal end and a distal end and a longitudinal axis extending therethrough, the expandable frame portion comprising a plurality of foreshortening cells configured to collapse radially for delivery and to expand radially upon deployment;

a proximal anchoring portion extending from the expandable frame portion and expandable from a collapsed configuration to an expanded configuration, wherein when the proximal anchoring portion is in an expanded configuration;

at least a portion of the proximal anchoring portion extends proximally; and

at least a portion of the proximal anchoring portion extends radially outwardly in a direction generally perpendicular to the longitudinal axis, the portion of the proximal anchoring portion that extends radially outwardly being sized and shaped to contact an atrial side of a native valve annulus;

a distal anchoring portion extending from the expandable frame portion and expandable from a collapsed configuration to an expanded configuration, the distal anchoring portion comprising a plurality of distal anchors which are each connected to the expandable frame portion at a first base and a second base spaced apart from each other, wherein when the distal anchoring portion is in an expanded configuration;

at least a portion of each distal anchor extends radially outward from the expandable frame portion; and

at least one distal anchor comprises at least one bend, the end of the at least one distal anchor extending toward the proximal end of the expandable frame portion; and

a skirt annularly positioned around an exterior of the expandable frame portion to create an axial barrier to fluid flow exterior to the expandable frame portion when deployed within the body cavity, the skirt comprising;

a first portion sized and shaped to extend along and follow the shape of the exterior of expandable frame portion when the expandable frame portion is in an expanded configuration, the first portion having a proximal end and a distal end,

a second portion configured to be positioned radially between the expandable frame portion and the distal anchoring portion when the expandable frame portion is in an expanded configuration, the second portion extending from the distal end of the first portion and extending at least along an inwardly facing surface of the distal anchoring portion; and

a third portion extending radially outward from the expandable frame portion when the expandable frame portion is in an expanded configuration, the third portion extending radially outward from a location spaced from the proximal end of the expandable frame portion, the third portion extending from the proximal end of the first portion and extending along at least a portion of the plurality of proximal anchors, wherein an end of the third portion is positioned further radially outward from the longitudinal axis than the ends of the distal anchors; and

a plurality of locking tabs extending proximally, wherein when the expandable frame portion is in an expanded configuration the plurality of locking tabs extend proximally of the expandable frame portion and the proximal anchoring portion.

21. The prosthesis of claim 20, wherein the expandable frame portion is configured to longitudinally foreshorten upon radial expansion and wherein the proximal anchoring portion and at least the plurality of anchors of the distal anchoring portion are separated by the plurality of foreshortening cells such that the proximal anchoring portion and at least the plurality of anchors of the distal anchoring portion are configured to be drawn closer together along the longitudinal axis when the expandable frame portion foreshortens.

22. The prosthesis of claim 20, wherein the third portion of the skirt extends in a direction generally perpendicular to the longitudinal axis.

23. The prosthesis of claim 20, wherein the third portion of the skirt forms an annular ring.

24. The prosthesis of claim 20, wherein the entirety of the third portion of the skirt is positioned distal of proximal ends of the foreshortening cells.

25. A prosthesis configured to grasp intralumenal tissue when deployed within a native mitral valve, the prosthesis comprising:

an expandable frame portion comprising a proximal end and a distal end and a longitudinal axis extending therethrough, the expandable frame portion comprising a proximal row of foreshortening cells and a distal row of foreshortening cells, the foreshortening cells configured to collapse radially for delivery and to expand radially upon deployment, the expandable frame portion being configured to longitudinally foreshorten upon radial expansion;

a plurality of proximal anchors extending from the expandable frame portion and expandable from a collapsed configuration to an expanded configuration, each of the proximal anchors extending from junctions between the proximal row of foreshortening cells, wherein in an expanded configuration, ends of the plurality of proximal anchors are positioned radially outwardly relative from the expandable frame portion and extend in a direction substantially perpendicular to the longitudinal axis, the ends being axially positioned distal of the proximal end of the expandable frame portion;

a plurality of distal anchors extending from the expandable frame portion and expandable from a collapsed configuration to an expanded configuration, each of the distal anchors connected to a base at a distal portion of the distal row of foreshortening cells, wherein in an expanded configuration, ends of the plurality of distal anchors are positioned radially outwardly relative from the expandable frame portion and the axial length between the base and the ends is less than a length of the cells of the distal row when in an expanded configuration; and

a skirt annularly positioned around an exterior of the expandable frame portion to create an axial barrier to fluid flow exterior to the expandable frame portion when deployed within the body cavity, the skirt comprising;

a generally cylindrical portion having a proximal end and a distal end; and

a ring-shaped portion extending radially outward from the frame at a location axially spaced from the proximal end to prevent axial flow of fluid around an exterior of the prosthesis, the ring-shaped portion comprising an inner edge extending from the proximal end of generally cylindrical portion of the skirt, the ring-shaped portion extending radially outwardly from the inner edge to an outer edge;

wherein the proximal anchors and distal anchors are configured to be drawn closer together along the longitudinal axis when the expandable frame portion foreshortens.

26. The prosthesis of claim 25, wherein the expandable frame portion comprises a plurality of longitudinally extending struts, wherein one or more of the longitudinally extending struts extends distally from an apex of a foreshortening cell and comprises at least one eyelet extending through the longitudinally extending strut for attaching a valve to the expandable frame.