MODULAR ENDOGRAFT DEVICES AND ASSOCIATED SYSTEMS AND METHODS

• US 20110130825A1
• Filed: 12/01/2010
• Published: 06/02/2011
• Est. Priority Date: 12/01/2009
• Status: Abandoned Application

• Current Assignee: Altura Medical, Inc. (Lombard Medical, Inc.)
• Original Assignee: Altura Medical, Inc. (Lombard Medical, Inc.)
• Inventors: Cragg, Andrew H., Fulkerson, John, Rizk, Isa, Logan, John, Sosnowski, Stephen
• Application Number:
  US12/958,381
• Publication Number:
  US 20110130825A1
• 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 a first superior portion, a first inferior portion, and a first lumen through the first superior and inferior portions, wherein the first superior portion has a first superior terminus, a first outer wall, and a first septal wall;

a second endograft device having a second superior portion, a second inferior portion, and a second lumen through the second superior and inferior portions, wherein the second superior portion has a second superior terminus, a second outer wall, and a second septal wall;

wherein the first and second septal walls of the first and second endograft devices press against one another and form a septum; and

wherein the first superior terminus of the first endograft device is superior to the second superior terminus of the second endograft device such that the first and second endograft devices are longitudinally staggered and a free end portion of the first superior portion is positioned distally beyond the second superior terminus.

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

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

the second outer wall and the second septal wall define a second complex ellipsoid, wherein the second outer wall has the first radius and the second septal wall has the second radius;

the first and second complex ellipsoids have a substantially D-shaped cross section; and

the first and second endograft devices are configured to self-expand via an inherent spring force such that the first and second septal walls exert opposing forces against each other.

3. The modular endograft system of claim 2 wherein the opposing forces between the first and second septal walls are substantially uniform along the septum.

4. The modular endograft system of claim 1 wherein the first and second septal walls are at least substantially straight along the septum and the free end portion of the first superior portion is at least substantially longitudinally aligned with the first septal wall at the septum.

5. The modular endograft system of claim 4 wherein the first endograft device has an integrated, self-expanding frame configured to have integrated, continuous support longitudinally along the frame such that each area of the frame influences the radial expansion or contraction of an adjacent area of the frame.

6. The modular endograft system of claim 1 wherein the first and second inferior portions have a substantially circular cross-section.

7. The modular endograft system of claim 1 wherein:

the first endograft device has a first frame and a first cover attached to the first frame, the first cover having a plurality of first circumferential ribs;

the second endograft device has a second frame and a second cover attached to the second frame, the second cover having a plurality of second circumferential ribs; and

wherein the first and second circumferential ribs interface at the septum.

8. The modular endograft system of claim 1 wherein:

the first septal wall is convexly curved in an opposite direction relative to the first outer wall, and the first septal wall and the first outer wall are joined at curved corners; and

the second septal wall is convexly curved in an opposite direction relative to the second outer wall, and the second septal wall and the second outer wall are joined at curved corners.

9. The modular endograft system of claim 8 wherein:

the first outer wall and the second outer wall each have a first radius of curvature;

the first septal wall and the second septal wall each have a second radius of curvature greater than the first radius of curvature; and

the curved corners have a radius of curvature less than the first radius of curvature, and wherein the curved corners form an angle from approximately 60°

to approximately 100°

at the septum in an expanded configuration.

10. The modular endograft system of claim 1 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.

11. The modular endograft system of claim 1 wherein:

the first endograft device has a first braided frame configured to have a spring force that self-expands radially outward from a constricted profile to an expanded profile and a first cover attached to the first braided frame, the first cover having a first inferior terminus and a first superior terminus, and the first braided frame having a first end extending distally beyond the first superior terminus of the first cover and second end extending proximally beyond the first inferior terminus of the first cover;

the second endograft device has a second braided frame configured to have a spring force that self-expands radially outward from a constricted profile to an expanded profile and a second cover attached to the second braided frame, the second cover having a second inferior terminus and a second superior terminus, and the second braided frame having a first end extending distally beyond the second superior terminus of the second cover and a second end extending proximally beyond the second inferior terminus of the second cover; and

wherein the first ends of the first and second frames include openings through which blood can flow laterally relative to the first and the second lumens.

12. The modular endograft system of claim 11, wherein the first and second braided frames are woven from wire such that each longitudinal segment of each frame supports adjacent longitudinal segments along the length of each frame.

13. The modular endograft system of claim 1 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 the expanded configuration and constricts in a low-profile configuration.

14. The modular endograft system of claim 1 wherein:

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 a first cross-sectional dimension at the superior portion to a second cross-sectional dimension less than the first cross-sectional dimension at the inferior portion, wherein the transition portion is 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 at the second superior portion to the second cross-sectional dimension at the second inferior portion, wherein the second transition portion is configured to maintain substantially laminar blood flow through the second lumen in the expanded configuration.

15. The modular endograft system of claim 1 wherein:

the first endograft device has a first frame and a first cover attached to a portion of the first frame, the first frame comprising an open braided wire, and the first cover having a first opening at the first outer wall;

the second endograft device has a second frame and a second cover attached to the second frame, the second frame comprising an open braided wire, and the second cover having a second opening at the second outer wall; and

wherein the first and second openings allow blood to flow laterally relative to the first and second lumens.

16. The modular endograft system of claim 1 wherein:

the first endograft device has a first frame and a first cover attached to a portion of the first frame, the first frame comprising an open braided wire, and the first cover having a first opening at the first inferior portion, and wherein the first opening allows blood to flow laterally through the first opening relative to the first lumen.

17. A modular endograft system, comprising:

a first endograft device having a 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 convexly curved first outer wall and a first septal wall;

a second endograft device having a 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 convexly curved second outer wall and a second septal wall;

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

wherein the first and second endograft devices are longitudinally staggered with respect to the each other in the expanded configuration such that the first frame includes a first free end portion projecting distally beyond the second superior portion of the second endograft device.

18. The modular endograft system of claim 17 wherein the first and second frames each include a superior terminus, an inferior terminus, and a continuous wire woven in a braid, the wire crossing itself at a braid angle, and the wire reversing direction at the superior terminus of the frame to form a first plurality of loops and reversing direction at the inferior terminus of the frame to form a second plurality of loops

19. The modular endograft system of claim 18 wherein the braid angle is from approximately 30°

to approximately 45°

.

20. The modular endograft system of claim 17 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.

21. The modular endograft system of claim 17 wherein the first and second covers extend over the first and second frames, respectively, and wherein the first and second covers are configured to limit radial expansion and longitudinal contraction of the first and second frames in the expanded configuration.

22. The modular endograft system of claim 17 wherein:

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

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

wherein the first and second ribs interface at the septum in the expanded configuration.

23. The modular endograft system of claim 17 wherein:

the first and second superior portions 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.

24. The modular endograft system of claim 17 wherein:

the first frame comprising an open braided wire and the first cover having a first opening at the first outer wall;

the second frame comprising an open braided wire, and the second cover having a second opening at the second outer wall; and

wherein the first and second openings allow blood to flow laterally relative to a longitudinal axis of the first lumen and second lumens.

25. The modular endograft system of claim 24 wherein the first cover of the first endograft device has a third opening at the first inferior portion, and wherein the third opening allows blood to flow laterally through the third opening from the first lumen.

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

advancing a first endograft device through the first blood vessel to a target site in the primary blood vessel before the aneurysm;

advancing a second endograft device through the second blood vessel to the target site independently of advancing the first endograft device through the first blood vessel;

deploying the first and second endograft devices at the target site by separately expanding the first and second endograft devices to an expanded configuration such that opposing portions of first and second septal walls of the first and second endograft devices, respectively, press against each other to form a septum between the first and second endograft devices; and

wherein a first superior portion of the first endograft device is longitudinally staggered relative to a second superior portion of the second endograft device such that a free end portion of the first superior portion projects distally beyond a terminus of the second endograft device.

27. The method of claim 26, 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.

28. The method of claim 27 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.

29. The method of claim 26 wherein the first endograft device includes a first alignment aid at the first septal wall and 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 oppose one 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 form the septum.

30. The method of claim 29 wherein the first and second alignment aids diagonally cross the first and second septal walls, and wherein the first and second alignment aids form an “

X”

indicator at the septum.

31. The method of claim 26 wherein the first and second endograft devices each include a frame and a cover, at least a portion of the cover being attached over the frame, and at least a portion of the cover having a plurality of circumferential ribs projecting radially from the frame, and wherein deploying the first and second endograft devices further comprises:

interfacing the circumferential ribs at the first septal wall with the circumferential ribs at the second septal wall at the septum; and

interfacing the circumferential ribs at the first and second outer walls with a vessel wall of the primary blood vessel.

32. The method of claim 26 wherein the first and second endograft devices each include a cover attached over at least a portion of a frame, and deploying the first and second endograft devices further comprises restricting radial expansion of the frames with the covers.

33. The method of claim 26 wherein the primary blood vessel is an aorta and the first blood vessel is a first common iliac artery and the second blood vessel is a second common iliac artery, and wherein deploying the first and second endograft devices further includes:

at least substantially sealing a proximal end of a first inferior portion of the first endograft device with an arterial wall of the first common iliac artery; and

at least substantially sealing a proximal end of a second inferior portion of the second endograft device with an arterial wall of the second common iliac artery.

34. The method of claim 26 wherein the first septal wall is convexly curved in a direction opposite a first outer wall of the first endograft device and a second septal wall of the second endograft device is convexly curved in a direction opposite the second outer wall, and wherein deploying the first and second endograft devices comprises urging opposing portions of the convexly curved first and second septal walls together.

35. The method of claim 34 wherein urging convexly the curved first and second septal walls together results in a substantially uniform distribution of pressure between the opposing portions of the first and second septal walls.

36. The method of claim 26 wherein the primary blood vessel includes a third blood vessel and a fourth blood vessel branching from the primary blood vessel before the aneurysm, the third and fourth blood vessels being longitudinally offset from one another relative to the primary blood vessel, and wherein:

the first endograft device has a first braided frame and a first cover coupled to the first braided frame, the first cover having a first inferior terminus and a first superior terminus, and the first braided frame having a first end extending distally beyond the first superior terminus of the first cover and second end extending proximally beyond the first inferior terminus of the first cover, wherein the first and second end portions include openings through which blood can flow laterally relative to a longitudinal axis of the first lumen;

the second endograft device has a second braided frame and a second cover attached to the second braided frame, the second cover having a second inferior terminus and a second superior terminus, and the second braided frame having a first end extending distally beyond the second superior terminus of the second cover and a second end extending proximally beyond the second inferior terminus of the second cover, wherein the first and second end portions include openings through which blood can flow laterally relative to a longitudinal axis of the second lumen; and

staggering the first and second endograft devices comprises positioning the first end portion of the first frame at the entrance of the third blood vessel and positioning the first end portion of the second frame at the entrance of the fourth blood vessel such that the third and fourth blood vessels are in fluid communication with blood flow through the first and the second lumens.

37. The method of claim 26 wherein the primary blood vessel includes a third blood vessel and a fourth blood vessel branching from the primary blood vessel before the aneurysm, the third and fourth blood vessels being longitudinally, offset from one another relative to the primary blood vessel, and wherein:

the first endograft device includes a first frame and a first cover attached to a portion of the first frame, the first frame comprising an open braided wire, and the first cover having a first opening at the first outer wall;

the second endograft device includes a second frame and a second cover attached to the second frame, the second frame comprising an open braided wire, and the second cover having a second opening at the second outer wall, wherein the first and second openings allow blood to flow laterally relative to a longitudinal axis of the first and second lumens; and

staggering the first and second endograft devices comprises positioning the first opening of the first frame at the entrance of the third blood vessel and positioning the second opening of the second frame at the entrance of the fourth blood vessel such that the third and fourth blood vessels are in fluid communication with blood flow through the first and the second lumens.

38. The method of claim 26 wherein the first blood vessel includes a third blood vessel branching from the first blood vessel after the aneurysm, and wherein:

the first endograft device includes a first frame and a first cover attached to a portion of the first frame, the first frame comprising an open braided wire, and the first cover having a first opening at the first inferior portion; and

the method further comprises positioning the first opening of the first frame at the entrance of the third blood vessel such that blood from the first lumen flows laterally through the first opening to the third blood vessel.

39. The method of claim 26 wherein the first and second endograft devices include first and second frames, respectively, and the first and second frames are configured to provide continuous support such that the free end portion at least substantially aligned with the first septal wall at the septum.