MODULAR ENDOGRAFT DEVICES AND ASSOCIATED SYSTEMS AND METHODS

• US 20110130826A1
• 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, Logan, John, Sosnowski, Stephen, Cragg, Andrew H., Fulkerson, John
• Application Number:
  US12/958,383
• Publication Number:
  US 20110130826A1
• 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 cuff having a proximal end portion and a distal end portion;

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 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 outer wall and a second septal wall; and

wherein the first and second endograft devices are configured such that the first and second outer walls of the first and second endograft devices press against the cuff and the first and second septal walls exert opposing forces toward one another to fix the cuff to the first and second lumens.

2. The modular endograft system of claim 1 wherein the cuff has a substantially circular cross section and at least one of the proximal and distal end portions of the cuff is flared radially outward.

3. The modular endograft system of claim 1 wherein the cuff includes a cuff frame having a proximal terminus and a distal terminus and a sleeve radially inward from the cuff frame, wherein the sleeve extends over the proximal and distal termini of the cuff frame.

4. The modular endograft system of claim 1 wherein:

the cuff includes a sleeve and a cuff frame at least partially enclosing the sleeve;

the sleeve bifurcates the cuff into a first cuff lumen and a second cuff lumen; and

the first superior portion of the first endograft device contacts the first cuff lumen and the second superior portion of the second endograft device contacts the second cuff lumen.

5. The modular endograft system of claim 1 wherein the first and second superior portions of the first and second endograft devices, respectively, project distally beyond the distal end portion of the cuff such that portions of the first and second outer walls of the endograft devices affix to an adjacent vessel wall.

6. The modular endograft system of claim 1 wherein:

the first superior portion of the first endograft device includes a convexly curved first outer wall having a first radius and a convexly curved first septal wall having a second radius greater than the first radius such that the first superior portion has a D-like cross-section;

the second superior portion of the second endograft device includes a convexly curved second outer wall having the first radius and a convexly curved second septal wall having the second radius such that the second superior portion has a D-like cross-section;

wherein the first and second outer walls press against the cuff device in an expanded configuration; and

the first and second septal walls press against each other in the expanded configuration and form a septum, and the convex curvature of the first and second septal walls results in a substantially uniform distribution of pressure along the septum.

7. The modular endograft system of claim 6 wherein:

the first septal wall and the first outer wall are joined at curved corners;

the second septal wall and the second outer wall are joined at curved corners; and

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

to approximately 100°

at the septum in the expanded configuration.

8. The modular endograft system of claim 1, further comprising at least one anchor coupled to an exterior of the cuff, wherein the anchor protrudes radially from the cuff in an expanded configuration and constricts in a low-profile configuration.

9. The modular endograft system of claim 1 wherein the first and second endograft devices include at least one anchor at the first and second superior portions, wherein the anchor protrudes radially from the superior portions in an expanded configuration.

10. The modular endograft system of claim 1 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, wherein the second alignment aid crosses the first alignment aid when the first and second septal walls of the first and second endograft devices, respectively, oppose one another such the first and second septal walls form a septum.

11. The modular endograft system of claim 1 wherein:

the cuff includes a first cuff alignment aid and a second cuff alignment aid;

the first endograft device includes a first alignment aid at the first outer wall, wherein the first alignment aid crosses the first cuff alignment aid when the first outer wall opposes the cuff; and

the second endograft device includes a second alignment aid at the second outer wall, wherein the second alignment aid crosses the second cuff alignment aid when the second outer wall opposes the cuff.

12. 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 transitional portion is configured to maintain substantially laminar blood flow through the first lumen in an expanded configuration;

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 transitional portion is configured to maintain substantially laminar blood flow through the second lumen in the expanded configuration; and

the cuff further includes a transitional cuff portion at the proximate end portion, the tapered cuff portion being substantially conformal to the first and second tapered transitional portions.

13. The modular endograft system of claim 1 wherein the first and second endograft devices each include a frame having 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.

14. The modular endograft system of claim 13 wherein the first and second endograft devices each further include a cover over at least a portion of the frame, the cover having circumferential ribs protruding radially from the frame such that opposing circumferential ribs of the first and second septal walls mate in the expanded configuration.

15. A modular endograft system, comprising:

a cuff having a cuff frame and a sleeve attached to the cuff frame, wherein the cuff frame and the sleeve have a proximal end portion and a distal end portion;

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 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 convexly curved 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 expand to an expanded profile configuration with a second cross-sectional dimension greater than the first cross-sectional dimension such that in the expanded configuration the first and second septal walls are urged toward each other and form a septum between the first and second lumens and the first and second outer walls press against an interior of the cuff.

16. The modular endograft system of claim 15 wherein at least one of the proximal and distal end portions of the cuff frame is flared radially outward.

17. The modular endograft system of claim 16 wherein the sleeve extends over proximal and distal ends of the cuff frame such that the sleeve attaches to the cuff frame when the cuff presses against vessel walls.

18. The modular endograft system of claim 15 wherein the sleeve includes a first cuff lumen configured to receive the first endograft device and a second cuff lumen configured to receive the second endograft device.

19. The modular endograft system of claim 15 wherein the first and second endograft devices are staggered longitudinally relative to the first and second lumens such that the first superior portion includes a free end portion projecting distally beyond the second superior portion of the second endograft device.

20. The modular endograft system of claim 15 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 to form a first plurality of loops and reversing direction at the inferior terminus to form a second plurality of loops

21. The modular endograft system of claim 20 wherein the braid angle is from approximately 30°

to approximately 45°

.

22. The modular endograft system of claim 20 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.

23. The modular endograft system of claim 15 wherein the first and second covers extend over the first and second frames, and wherein the first and second covers limit at least one of radial expansion and longitudinal contraction of the first and second frames, respectively, in the expanded configuration.

24. The modular endograft system of claim 15 wherein:

at least a portion of the sleeve is radially inward from the cuff frame, and wherein the sleeve includes ribs protruding radially inward from the cuff frame;

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

wherein the first and second ribs interface with the ribs of the sleeve in the expanded configuration.

25. The modular endograft system of claim 15, further comprising at least one anchor protruding radially outward from an exterior of the cuff.

26. The modular endograft system of claim 15 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.

27. 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 cuff through the first blood vessel to a target site in the primary blood vessel before the aneurysm, the cuff having a substantially circular cross-section;

deploying the cuff at the target site such that the cuff presses against a vessel wall of the primary blood vessel;

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

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

deploying the first and second endograft devices at the target site such that the first and second endograft devices expand to an expanded configuration via inherent spring forces in the first and second endograft devices such that first and second septal walls of the first and second endograft devices, respectively, press toward each other and form a septum between the first and second endograft devices, and wherein first and second outer walls of the first and second endograft devices, respectively, sealably press against an interior surface of the cuff; and

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

28. The method of claim 27 wherein positioning the first and second endograft devices independently comprises:

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

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

29. The method of claim 27, 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.

30. The method of claim 29 wherein the first and second endograft devices have a cross-sectional dimension no less than 20 mm in the dilated configuration, and wherein the first and second catheters are no larger than 12 F.

31. The method of claim 27 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 can form the septum.

32. The method of claim 31 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.

33. The method of claim 27 wherein the cuff includes a cuff frame and an internal sleeve having ribs protruding radially inward from the cuff frame, the first and second endograft devices each include a cover having a plurality of circumferential ribs at least at the first and second septal and outer walls of the first and second endograft devices, respectively, 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; and

interfacing the circumferential ribs at the first and second outer walls with the ribs of the internal sleeve.

34. The method of claim 27 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.

35. The method of claim 27 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 cuff and the first and second endograft devices further includes:

at least substantially sealing the cuff with an arterial wall of the aorta;

at least substantially sealing the first inferior portion with an interior arterial wall of the first common iliac artery; and

at least substantially sealing the second inferior portion with an interior arterial wall of the second common iliac artery.

36. The method of claim 27 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;

deploying the cuff comprises positioning the cuff proximal to the third and fourth blood vessels; 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 third and fourth blood vessels are in fluid communication with blood flow through the first and the second lumens.