MODULAR ENDOGRAFT DEVICES AND ASSOCIATED SYSTEMS AND METHODS

• US 20110130824A1
• Filed: 12/01/2010
• Published: 06/02/2011
• Est. Priority Date: 12/01/2009
• Status: Active Grant

• Current Assignee: Lombard Medical Limited (MicroPort Scientific Corp.)
• Original Assignee: Altura Medical, Inc. (Lombard Medical, Inc.)
• Inventors: Cragg, Andrew H., Fulkerson, John, Rizk, Isa, Logan, John, Sosnowski, Stephen
• Granted Patent: US 9,572,652 B2
• Time in Patent Office: Days
• US Class Current: 623/1.15
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/89 the wire-like elements comprising two or more adjacent rings flexibly connected by separate members
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2002/061 provided with means for allowing access to secondary lumens
• CPC Class Codes: A61F 2002/067 modular
• CPC Class Codes: A61F 2002/072 Encapsulated stents, e.g. wire or whole stent embedded in lining
• CPC Class Codes: A61F 2002/8486 provided on at least one of the ends
• CPC Class Codes: A61F 2230/0034 D-shaped
• CPC Class Codes: A61F 2250/0039 differing in diameter

Abstract

Modular endograft devices and associated systems and methods are disclosed herein. In several embodiments, an endograft system can include a first endograft device and a second endograft device that each include an integrated frame, a cover and a lumen within the cover. Each endograft device further includes a superior portion and an inferior portion. The superior portion can have a convexly curved outer wall and a septal wall. The first and second endograft devices can be configured to extend into a low-profile configuration with a first cross-sectional dimension and a first length and self-expand into an expanded configuration with a second cross-sectional dimension greater than the first cross-sectional dimension and a second length less than the first length. In the expanded configuration, the septal walls can press against each other and form a septum between the lumens of the first and second endograft devices.

Claims

1. A modular endograft system, comprising:

a first endograft device having an integrated first frame (“

first frame”

), a first cover attached to the first frame, and a first lumen within the first cover, wherein the first frame and the first cover have a first superior portion and a first inferior portion, and the first superior portion has a first outer wall and a first septal wall;

a second endograft device having an integrated second frame (“

second frame”

), a second cover attached to the second frame, and a second lumen within the second cover, wherein the second frame and the second cover have a second superior portion and a second inferior portion, the second superior portion having a second outer wall and a second septal wall; and

wherein the first and second endograft devices are configured to be extended into a low-profile configuration with a first cross-sectional dimension and a first length and self-expand to an expanded configuration with a second cross-sectional dimension greater than the first cross-sectional area and a second length less than the first length such that in the expanded configuration the first and second septal walls press against each other and form a septum between the first and second lumens.

2. The modular endograft system of claim 1 wherein:

the first cover has a first superior terminus and the second cover has a second superior terminus;

the first frame includes a first end portion extending distally from the first superior terminus of the first cover, wherein the first end portion is configured to allow transverse fluid flow relative to a longitudinal axis of the first lumen; and

the second frame includes a first end portion extending distally from the second superior terminus of the second cover, wherein the second end portion is configured to allow transverse fluid flow relative to a longitudinal axis of the second lumen.

3. The modular endograft system of claim 1 wherein:

the first cover has a first inferior terminus and the second cover has a second inferior terminus;

the first frame includes a second end portion extending proximally from the first inferior terminus of the first cover, wherein the second end portion is configured to allow transverse blood flow relative to a longitudinal axis of the first lumen; and

the second frame includes a second end portion extending proximally from the second inferior terminus of the second cover, wherein the second end portion is configured to allow transverse fluid flow relative to a longitudinal axis of the second lumen.

4. The modular endograft system of claim 1 wherein:

the first and second frames each include a continuous wire woven in a braid, wherein the wire crosses itself at a braid angle.

5. The modular endograft system of claim 4 wherein:

the first frame includes a first superior terminus, a first inferior terminus, and wherein the wire reverses direction at the first superior terminus to form a first plurality of loops and reverses direction at the first inferior terminus to form a second plurality of loops; and

the second frame includes a second superior terminus, a second inferior terminus, and wherein the wire reverses direction at the second superior terminus to form a first plurality of loops and reverses direction at the second inferior terminus to form a second plurality of loops.

6. The modular endograft system of claim 4 wherein the wire is unbound where it crosses itself.

7. The modular endograft system of claim 4 wherein:

the first superior portion has a cross-sectional dimension of at least 20 mm in the expanded configuration and a cross-sectional dimension of at most 5 mm in the low-profile configuration; and

the second superior portion has a cross-sectional dimension of at least 20 mm in the expanded configuration and a cross-sectional dimension of at most 5 mm in the low-profile configuration.

8. The modular endograft system of claim 4 wherein the braid angle is from approximately 30°

to approximately 45°

.

9. The modular endograft system of claim 5 wherein the wire has a diameter from approximately 0.0070 inch to approximately 0.0140 inch and the first plurality of loops includes no more than eight loops and the second plurality of loops includes no more than eight loops.

10. The modular endograft system of claim 4 wherein the first and second frames each include a superior terminus and an inferior terminus, the wire is one of a plurality of wires, and wherein individual wires terminate at staggered points between the superior and inferior termini of the first and second frames.

11. The modular endograft system of claim 10 wherein the superior portion of the frame has a greater number of wires in the braid than the inferior portion of the frame.

12. The modular endograft system of claim 1 wherein:

the first cover has a first superior terminus and a first inferior terminus and the second cover has a second superior terminus and a second inferior terminus;

the first cover is attached over the first frame at the first superior terminus and the first inferior terminus of the first cover, wherein the first cover and the first frame are configured such that the first cover substantially conforms to the first frame in the expanded configuration; and

the second cover is attached over the second frame at the second superior terminus and the second inferior terminus of the second cover, wherein the second cover and the second frame are configured such that the second cover substantially conforms to the second frame in the expanded configuration.

13. The modular endograft system of claim 1 wherein:

the first cover includes a plurality of first ribs, the first ribs protruding radially from the first frame in the expanded configuration and being extendable longitudinally in the low-profile configuration;

the second cover includes a plurality of second ribs, the second ribs protruding radially from the second frame in the expanded configuration and being extendable longitudinally in the low-profile configuration; and

wherein the first ribs on the first septal wall mate with the second ribs at the second septal wall in the expanded configuration.

14. The modular endograft system of claim 1 wherein:

the first cover limits radial expansion of the first frame in the expanded configuration; and

the second cover limits radial expansion of the second frame in the expanded configuration.

16. The modular endograft system of claim 1 wherein:

the first and second superior portions of the first and second endografts, respectively, include alignment aids on opposing first and second septal walls, the alignment aids being configured to cross one another when the first and second septal walls form the septum.

17. The modular endograft system of claim 16 wherein each of the alignment aids diagonally cross the first and second septal walls, and wherein the first and second alignment aids form an “

X”

indicator when the first and second septal walls at the septum.

18. The modular endograft system of claim 16, wherein:

the first cover has a first superior terminus and the second cover has a second superior terminus;

the first alignment aid terminates at the first superior terminus of the first cover; and

the second alignment aid terminates at the second superior terminus of the second cover.

19. The modular endograft system of claim 1 wherein:

the first endograft device includes at least one anchor projecting radially from the first outer wall of the first frame in the expanded configuration; and

the second endograft device includes at least one anchor projecting radially from the second outer wall of the second frame in the expanded configuration.

20. The modular endograft system of claim 19 wherein the first and second anchors are retracted in the low-profile configuration and project inferiorly from the first and second outer walls in the expanded configuration.

21. The modular endograft system of claim 1 wherein the first cover includes an opening at the first outer wall through which blood can flow laterally across the first lumen.

22. The modular endograft system of claim 1 wherein:

the first and second lumens have a first cross-sectional dimension at the first and second superior portions and a second cross-sectional dimension less than the first cross-sectional dimension at the first and second inferior portions;

the first endograft device further includes a first transition portion between the first superior portion and the first inferior portion, the first transition portion tapering the first lumen from the first cross-sectional dimension to the second cross-sectional dimension and being configured to maintain substantially laminar blood flow through the first lumen in the expanded configuration; and

the second endograft device further includes a second transition portion between the second superior portion and the second inferior portion, the second transition portion tapering the second lumen from the first cross-sectional dimension to the second cross-sectional dimension and being configured to maintain substantially laminar blood flow through the second lumen in the expanded configuration.

23. The modular endograft system of claim 1 wherein the first and second outer and septal walls are convexly curved, and wherein:

the first outer wall and the first septal wall define a first complex ellipsoid, the first outer wall having a first radius, and the first septal wall having a second radius greater than the first radius;

the second outer wall and the second septal wall define a second complex ellipsoid, the second outer wall having the first radius, and the second septal wall having the second radius greater than the first radius; and

the first and second complex ellipsoids have a substantially D-like shape and relative forces between first and second septal walls in the expanded configuration are substantially uniform along the septum.

15. The modular endograft system of 1 wherein:

the first cover includes a first superior terminus and a first inferior terminus, and at least one of the first superior terminus and the first inferior terminus is zigzagged; and

the second cover includes a second superior terminus and a second inferior terminus, and at least one of the second superior terminus and the second inferior terminus is zigzagged.

24. A modular endograft system, comprising:

a first endograft device having a first frame, a first cover, and a first lumen within the first cover, wherein the first frame and the first cover have a first superior portion and a first inferior portion, and the first superior portion has a convexly curved first outer wall and a first septal wall;

a second endograft device having a second frame, a second cover, and a second lumen within the second cover, wherein the second frame and the second cover have a second superior portion and a second inferior portion, the second superior portion having a convexly curved second outer wall and a second septal wall;

wherein the first and second frames are configured to have substantially continuous longitudinal support along the superior and inferior portions of the first and second endograft devices, respectively; and

wherein the first and second septal walls press against each other and form a septum in an expanded configuration between the first and second lumens.

25. The modular endograft system of claim 24 wherein the first and second frames are braided frames woven from a wire such that each longitudinal segment of each frame supports adjacent longitudinal segments along the length of each frame.

26. The modular endograft system of claim 25 wherein each longitudinal segment of the frame influences the radial expansion or contraction of the adjacent longitudinal segment of the frame.

27. The modular endograft system of claim 25 wherein the first and second frames each include a superior terminus and an inferior terminus, and a wire crossing itself at a braid angle, and wherein the wire reverses direction at the superior terminus to form a first plurality of loops and reverses direction at the inferior terminus to form a second plurality of loops the wire.

28. The modular endograft system of claim 27 wherein the wire crosses itself at a braid angle between approximaly 30°

and approximately 45°

.

30. The modular endograft system of claim 24 wherein:

the first and second superior portions have a cross-sectional dimension of at least 20 mm in the expanded configuration and a cross-sectional dimension of at most 5 mm in the low-profile configuration.

31. The modular endograft system of claim 24 wherein the first endograft device has a first alignment aid and the second endograft device has a second alignment aid, wherein the first and second alignment aids are configured to indicate a rotational orientation and a longitudinal position of the first and second endograft devices relative to each other.

32. The modular endograft system of claim 24 wherein the first and second endograft devices each include at least one anchor at the superior portion, wherein the anchor protrudes radially from the outer wall in an expanded configuration and constricts in a low-profile configuration.

33. The modular endograft system of claim 24 wherein at least a portion of the first and second covers have a plurality of circumferential ribs projecting radially from the first and second frames, respectively, and wherein the circumferential ribs at the first septal wall of the first endograft device are configured to mate with the circumferential ribs at the second septal wall of the second endograft device at the septum.

34. The modular endograft system of claim 24 wherein the first cover includes an opening at the first outer wall, wherein the blood can flow laterally through the opening across the first lumen.

35. The modular endograft system of claim 24 wherein the first and second septal walls are convexly curved, and wherein:

the first and second outer walls and the first and second septal walls define first and second complex ellipsoids, respectively, the first and second outer walls having a first radius, and the first and second septal walls having a second radius greater than the first radius;

the first and second complex ellipsoids have a substantially D-like shape and relative forces between first and second septal walls in the expanded configuration are substantially uniform along the septum;

the first and second lumens have a first cross-sectional dimension at the first and second superior portions and a second cross-sectional dimension less than the first cross-sectional dimension at the first and second inferior portions; and

the first and second endograft devices each include a transition portion between the superior portion and the inferior portion, the transition portion tapering the lumen from the first cross-sectional dimension to the second cross-sectional dimension and being configured to maintain substantially laminar blood flow through the lumen in the expanded configuration.

29. The modular endograft system of 28 wherein:

the first and second covers each include a superior terminus and an inferior terminus, and at least one of the superior and inferior termini of the cover conforms to the braid angle.

36. A method of repairing an aneurysm in a primary blood vessel before the primary blood vessel bifurcates into a first blood vessel and a second blood vessel, the method comprising:

advancing a first endograft device through the first blood vessel to a target site in the primary blood vessel to a target site before the aneurysm, wherein the first endograft device includes a first frame, a first cover, and a first lumen within the first cover, wherein the first frame and the first cover have a first superior portion and a first inferior portion, the first superior portion having a first outer wall and a first septal wall;

advancing a second endograft device through the second blood vessel to the target site, wherein the second endograft device includes a second frame, a second cover, and a second lumen within the second cover, wherein the second frame and the second cover have a second superior portion and a second inferior portion, and the second superior portion having a second outer wall and a second septal wall;

deploying the first and second endograft devices at the target site such that the first and second endograft devices self-expand to an expanded configuration via inherent hoop forces in the first and second frames such that the first and second septal walls press against each other to form a septum between the first and second lumens, the first and second outer walls press against a vessel wall of the primary blood vessel; and

wherein the first and second endograft devices are positioned independently of one another.

37. The method of claim 36 wherein positioning the first and second endograft devices independently comprises:

positioning the first superior portion of the first endograft device in a first desired position; and

positioning the second superior portion of the second endograft device in a second desired position, wherein the first desired position is longitudinally offset from the second desired position along the primary vessel.

38. The method of claim 36, further comprising:

loading the first endograft device in a first catheter, wherein the first endograft device is extended in a low-profile configuration;

loading the second endograft device in a second catheter, wherein the second endograft device is extended in a low-profile configuration;

percutaneously introducing the first endograft device into the first blood vessel; and

percutaneously introducing the second endograft device into the second blood vessel.

39. The method of claim 36 wherein the first and second endograft devices have a cross-sectional dimension no less than 20 mm in the expanded configuration, and wherein the first and second catheters are no larger than 12 F.

40. The method of claim 36 wherein the first endograft device includes a first alignment aid at the first septal wall, wherein the second endograft device includes a second alignment aid at the second septal wall, the first and second alignment aids comprising a radiopaque material, and wherein deploying the first and second endograft devices further includes:

radiographically positioning the first and second alignment aids such that the first and second alignment aids are opposite another;

viewing the first and second alignment aids in the orthogonal plane; and

crossing the first and second alignment aids such that the first and second septal walls can form the septum.

41. The method of claim 40 wherein the first and second alignment aids diagonally cross the first and second septal walls, respectively, and wherein crossing the first and second alignment aids forms an “

X”

indicator.

42. The method of claim 36 wherein the first cover includes first ribs on the first septal wall and the second cover includes second ribs at the second septal wall, and wherein deploying the first and second endograft devices further comprise mating the first and second ribs.

43. The method of claim 36 wherein the first cover attaches over at least a portion of the first frame, the second cover attaches over at least a portion of the second frame, and deploying the first and second endograft devices further comprises:

restricting radial expansion of the first frame with the first cover; and

restricting radial expansion of the second frame with the second cover.

44. The method of claim 36 wherein the first cover includes an opening at the first outer wall of the first superior portion, and wherein deploying the first and second endograft devices further comprises:

positioning the opening at an entrance of a third blood vessel, the third blood vessel having transverse fluid flow relative to a longitudinal axis of the primary blood vessel, and wherein the opening allows blood to flow through the first lumen and to the third blood vessel.