MODULAR ENDOGRAFT DEVICES AND ASSOCIATED SYSTEMS AND METHODS

• US 20110130819A1
• 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: Rizk, Isa, Cragg, Andrew H., Fulkerson, John, Logan, John, Sosnowski, Stephen
• Application Number:
  US12/958,374
• Publication Number:
  US 20110130819A1
• Time in Patent Office: Days
• US Class Current: 623/1.2
• 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 having a smaller cross-sectional dimension than the first superior portion, and a first lumen through the first superior and first inferior portions, the first superior portion having a convexly curved first outer wall and a first septal wall that define a substantially D-shaped cross-section;

a second endograft device having a second superior portion, a second inferior portion having a smaller cross-sectional dimension than the second superior portion, and a second lumen through the second superior and second inferior portions, the second superior portion having a convexly curved second outer wall and a second septal wall that define a substantially D-shaped cross-section; and

wherein the first and second endograft devices are configured to self-expand into an expanded configuration via inherent hoop force of the first and second endograft devices such that 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 and second septal walls are convexly curved, and wherein:

the first outer wall and the first septal wall define a first complex ellipsoid in which 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 in which the second outer wall has the first radius and the second septal wall has the second radius; and

the self-expansion of the first and second endograft devices produces opposing forces between first and second septal walls in the expanded configuration.

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.

5. The modular endograft system of claim 1 wherein the inferior portions have a substantially circular cross-section.

6. 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; and

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 mated with the first circumferential ribs along at least a portion of the first and second septal walls.

7. 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.

8. The modular endograft system of claim 7 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.

9. The modular endograft system of claim 1 wherein the first endograft device has a first alignment marker and the second endograft device has a second alignment marker, wherein the first and second alignment markers are configured to indicate at least one of a rotational orientation and longitudinal position of the first and second endograft devices relative to each other.

10. The modular endograft device of claim 1 wherein:

the first endograft device has a first braided frame 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; and

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.

11. 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 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 a longitudinal axis of the first and second lumens.

12. A modular endograft system, comprising:

a first endograft device having a first superior portion with a first distal section, a first inferior portion, and a first lumen through the first superior and first inferior portions, the first superior portion having a convexly curved first outer wall and a first septal wall that define a substantially D-shaped cross-section;

a second endograft device having a second superior portion with a second distal section, a second inferior portion, and a second lumen through the second superior and second inferior portions, the second superior portion having a convexly curved second outer wall and a second septal wall that define a substantially D-shaped cross-section; and

wherein the first and second endograft devices are longitudinally staggered with respect to each other such that the first distal section of the first endograft device is positioned superiorly relative to the second distal section of the second endograft device.

13. The modular endograft system of claim 12 wherein:

the first endograft device has a first frame and a first cover attached to the first frame, the first cover having a first inferior terminus and a first superior terminus, and the first frame having a first end extending distally beyond the first superior terminus of the first cover, wherein the first end of the first frame defines the first distal section of the first endograft device; and

the second endograft device has a second frame and a second cover attached to the second frame, the second cover having a second inferior terminus and a second superior terminus, and the second frame having a first end extending distally beyond the second superior terminus of the second cover, wherein the first end of the second frame defines the second distal section of the second endograft device.

14. The modular endograft system of claim 13 wherein the first ends of the first and second frames have openings through which blood can flow laterally relative to a longitudinal axis of the first lumen and second lumens.

15. The modular endograft device of claim 12 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 in which 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 in which the second outer wall has the first radius and the second septal wall has the second radius; and

the self-expansion of the first and second endograft devices produces opposing forces between first and second septal walls in a expanded configuration.

16. The modular endograft system of claim 15 wherein the pressure between the first and second septal walls is substantially uniform along the septum.

17. The modular endograft system of claim 12 wherein the first and second septal walls are at least substantially straight.

18. The modular endograft system of claim 12 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.

19. The modular endograft system of claim 18 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 then the first radius of curvature.

20. The modular endograft system of claim 12 wherein:

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

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

21. A modular endograft system comprising:

a first endograft device having a first superior portion, a first inferior portion having a smaller cross-sectional dimension than the first superior portion, a first braided frame, and a first lumen through the first superior and first inferior portions, the first superior portion having a substantially D-shaped cross-section;

a second endograft device having a second superior portion, a second inferior portion having a smaller cross-sectional dimension than the second superior portion, a second braided frame, and a second lumen through the second superior and second inferior portions, the second superior portion having a substantially D-shaped cross-section;

wherein the first and second braided 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 superior portions press against each other and form a septum between the first and second lumens.

22. The modular endograft system of claim 21 wherein the first and second braided frames are woven from a wire such that each longitudinal segment of each frame supports adjacent longitudinal segments along the length of each frame.

23. The modular endograft system of claim 22 wherein each longitudinal segment of the frame influences the radial expansion or contraction of the adjacent longitudinal segment of the frame.

24. The modular endograft system of claim 21 wherein the first and second septal walls are convexly curved, and wherein:

the first superior portion includes a convexly curved first outer wall and a convexly curved first septal wall, 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 superior portion includes a convexly curved second outer wall and a convexly curved second septal wall, wherein the second outer wall has the first radius and the second septal wall has the second radius; 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.

25. The modular endograft system of claim 21 wherein the first endograft device has a first alignment aid and the second endograft device has a second alignment aid, and 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.

26. The modular endograft system of claim 21 wherein:

the first endograft device further includes a first tapered transition portion between the first superior portion and the first inferior portion, wherein the transition portion is configured to maintain substantially laminar blood flow through the first lumen in an expanded configuration; and

the second endograft device further includes a second tapered transition portion between the second superior portion and the second inferior portion, wherein the second transition portion is configured to maintain substantially laminar blood flow through the second lumen in an expanded configuration.

27. The modular endograft system of claim 21 wherein the first endograft device has a first cover attached to a portion of the first frame, and the first cover having a first opening, and wherein the first opening allows blood to flow laterally relative to the first lumen.

28. The modular endograft system of claim 21 wherein:

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

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

29. A method of treating an aneurysm located in a primary vessel before a bifurcation into a first vessel and a second vessel, comprising:

positioning a first endograft device relative to the aneurysm such that at least a segment of a first superior portion of the first endograft device is positioned superior to the aneurysm and a first inferior portion of the first endograft device extends at least partially through the aneurysm, the first superior portion having a convexly curved first outer wall and a first septal wall that define a substantially D-shaped cross-section;

positioning a second endograft device relative to an aneurysm such that at least a segment of a second superior portion of the second endograft device is positioned superior to the aneurysm and a second inferior portion of the second endograft device extends at least partially through the aneurysm, the second superior portion having a convexly curved second outer wall and a second septal wall that define a substantially D-shaped cross-section, and wherein the second endograft device is positioned independently of positioning the first endograft device;

deploying the first endograft device from a first catheter and deploying the second endograft device from a second catheter such that the first and second superior portions self-expand to an expanded configuration in which the first and second septal walls press against each other via an inherent spring force to form a septum between the first and second lumens.

30. The method of claim 29 wherein the first septal wall is convexly curved in a direction opposite the first outer wall and the second septal wall is convexly curved in a direction opposite the second outer wall, and wherein deploying the first and second endograft devices comprises urging the convexly curved first and second septal walls together.

31. The method of claim 30 wherein urging convexly the curved first and second septal walls together results in a more uniform distribution of pressure between the first and second septal walls compared to straight first and second septal walls.

32. The method of claim 29 wherein positioning the first and second endograft devices independently of each other comprises staggering the first superior portion of the first endograft device relative to the second superior portion of the second endograft device such that a portion of the first septal wall is positioned superior relative to a distal terminus of the second septal wall.

33. The method of claim 29 wherein:

the first catheter has a maximum cross-sectional dimension of 5 mm and the first outer wall of the first superior portion of the first endograft device has a radius of curvature not less than 10 mm after being deployed from the first catheter; and

the second catheter has a maximum cross-sectional dimension of 5 mm and the second outer wall of the second superior portion of the second endograft device has a radius of curvature not less than 10 mm after being deployed from the second catheter.

34. The method of claim 29 wherein:

the first catheter has a maximum cross-sectional dimension of 5 mm and the first outer wall of the first superior portion of the first endograft device has a radius of curvature not less than 10 mm after being deployed from the first catheter; and

the second catheter has a maximum cross-sectional dimension of 5 mm and the second outer wall of the second superior portion of the second endograft device has a radius of curvature not less than 10 mm after being deployed from the second catheter.

35. The method of claim 29 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 along the primary blood vessel, and 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, wherein the first and second openings allow blood to flow laterally relative to a longitudinal axis of the first lumen and second lumen; and

deploying 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 first and second endograft devices are staggered with respect to a longitudinal axis of the primary vessel.