Modular endograft devices and associated systems and methods

• US 9,572,652 B2
• Filed: 12/01/2010
• Issued: 02/21/2017
• 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., Sosnowski, Stephen, Rizk, Isa, Fulkerson, John, Logan, John
• Primary Examiner(s): WEISBERG, AMY REGINA
• Application Number:
  US12/958,367
• Publication Number:
  US 20110130824A1
• Time in Patent Office: 2,274 Days
• Field of Search: 623 111- 113, 623/1.35, 623/1.136, 623/1.44, 623/1.16, 606/200
• US Class Current: 1/1
• 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 method of repairing an aneurysm in an aorta of a human patient, the method comprising:

advancing a first endograft device to a target site in the aorta 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 that together define a substantially D-shaped cross-section;

advancing a second endograft device to the target site in the aorta, 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 that together define a substantially D-shaped cross-section, wherein the first and second endograft devices are positioned independently of one another;

longitudinally staggering a superior end of the first septal wall of the first frame of the first endograft device with respect to a superior end of the second septal wall of the second frame of the second endograft device within the aorta to accommodate the naturally anatomically variable orientation of renal arteries of the patient; and

deploying the staggered 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, wherein after deployment the first and second septal walls press against each other to form a septum between the first and second lumens with the superior ends of the first and second septal walls longitudinally staggered, and wherein the first and second outer walls press against a vessel wall of the aorta.

2. The method of claim 1, further comprising:

percutaneously introducing the first endograft device into the aorta via a first blood vessel; and

percutaneously introducing the second endograft device into the aorta via a second blood vessel different than the first blood vessel.

3. The method of claim 1 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 14 F.

4. The method of claim 1 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 comprises transforming the first and second ribs from a low-profile configuration with a first length and a first diameter to an expanded configuration with a second length shorter than the first length and a second diameter greater than the first diameter,

wherein the first and second ribs are arranged circumferentially about longitudinal axes of the first and second frames and, when deployed, project outwardly from the first and second frames, respectively, such that the first and second ribs mate with each other along the first and second septal walls.

5. The method of claim 1 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.

6. The method of claim 1 wherein the first cover includes an opening defined within, and entirely bounded by, 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 renal artery of the patient, the renal artery having transverse fluid flow relative to a longitudinal axis of the aorta, and wherein the opening allows blood to flow through the first lumen and to the renal artery.

7. The method of claim 1 wherein longitudinally staggering the ends of the first and second frames comprises longitudinally offsetting the superior end of the first frame from the superior end of the second frame by at least 5 mm.

8. The method of claim 1 wherein longitudinally staggering the ends of the first and second frames comprises treating an abdominal aortic aneurysm proximal to a short aortic neck by forming a sealing area between the first outer wall and the aorta that is larger than a sealing area of the second outer wall and the aorta.

9. The method of claim 1 wherein:

the first cover of the first frame is defined by a single layer of first cover graft material, wherein the first cover has a first cover outer surface and a first cover inner surface with the first cover graft material extending continuously therebetween;

the second cover of the second frame is defined by a single layer of second cover graft material, wherein the second cover has a second cover outer surface and a second cover inner surface with the second cover graft material extending continuously therebetween;

the first cover outer surface substantially conforms to the first frame when the first frame is in an expanded state;

the second cover outer surface substantially conforms to the second frame when the second frame is in an expanded state; and

the first and second covers contact each other at the first and second septal walls.

10. The method of claim 1 wherein longitudinally staggering the ends of the first and second frames comprises longitudinally offsetting the superior end of the first cover from the superior end of the second cover by at least 5 mm.

11. The method of claim 1 wherein:

the step of advancing the first endograft device to the target site includes simultaneously advancing the first frame and the first cover together, and

the step of advancing the second endograft device to the target site includes simultaneously advancing the second frame and the second cover together.

12. The method of claim 1 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.

13. The method of claim 12 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.

14. A method of treating an abdominal aortic aneurysm (AAA) of a human patient, the method comprising:

positioning a first endograft device in an abdominal aorta of the patient 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, wherein the first superior portion comprises a first braided frame with a convexly curved first outer wall and a first septal wall that define a substantially D-shaped cross-section, with at least a portion of the first braided frame having a first cover extending about the circumference of the first braided frame;

positioning a second endograft device in the abdominal aorta of the patient 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 longitudinally offset relative to the first braided frame of the first endograft device, and such that a free end portion of the first braided frame projects distally beyond the superior end of the second endograft device, wherein—

a second inferior portion of the second endograft device extends at least partially through the aneurysm,

the second superior portion comprises a second braided frame with a convexly curved second outer wall and a second septal wall that define a substantially D-shaped cross-section, the second braided frame defining the superior end of the second endograft device, with at least a portion of the second braided frame having a second cover extending about the circumference of the second braided frame, and

the second endograft device is positioned independently of 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,

wherein the free end portion of the first braided frame projecting distally beyond the superior end of the second superior portion at least substantially maintains the substantially D-shaped cross-section, and

wherein the septal wall of the first braided frame has the first cover thereon, the septal wall and its first cover projecting distally beyond the superior end of the second endograft device and its second cover after the first and second endograft devices are deployed.

15. The method of claim 14 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.

16. The method of claim 14 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.

17. The method of claim 14 wherein:

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

the second endograft device has a second cover attached to the second braided frame, 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 braided frame at the entrance of a first renal blood vessel of the patient and positioning the first end portion of the second braided frame at the entrance of a second renal blood vessel of the patient longitudinally offset from the first renal blood vessel, and

wherein the first and second endograft devices are staggered with respect to a longitudinal axis of the abdominal aorta in a manner to approximate the offset between the first and second renal arteries of the patient.

18. The method of claim 14, further comprising:

positioning a first limb such that a distal portion of the first limb is coupled to the first inferior portion of the first endograft device and a proximal portion of the first limb is in a first iliac artery of the patient; and

positioning a second limb such that a distal portion of the second limb is coupled to the second inferior portion of the second endograft device and a proximal portion of the second limb is in a second iliac artery of the patient.

19. The method of claim 14 wherein:

the first endograft has a first cover on the first braided frame, the first cover having a single layer of material;

the second endograft has a second cover on the second braided frame, the second cover having a single layer of material; and

the first and second covers press against each other at the septum.

20. The method of claim 14 wherein the first cover of the septal wall of the first braided frame projects distally beyond the second cover of the second endograft device by at least 5 mm.

21. The method of claim 14 wherein:

the step of positioning the first endograft device includes simultaneously positioning the first braided frame and the first cover together, and

the step of advancing the second endograft device includes simultaneously positioning the second braided frame and the second cover together.

22. A method of treating an aneurysm in an abdominal aorta of a human patient, the method comprising:

positioning a superior portion of a first endograft device in the aorta between the aneurysm and a first renal artery of the patient, wherein the superior portion of the first endograft device has a substantially D-shaped cross-section;

positioning a superior portion of a second endograft device in the aorta between the aneurysm and a second renal artery of the patient offset from the first renal artery of the patient, wherein the superior portion of the second endograft device has a substantially D-shaped cross-section;

sealing an outer wall of the superior portion of the first endograft device to a first portion of the aorta at least partially superior to the second renal artery of the patient and inferior to the first renal artery of the patient;

sealing an outer wall of the superior portion of the second endograft device to a second portion of the aorta offset from the first portion of the aorta and inferior to both the first and second renal arteries of the patient, wherein the first and second endograft devices each comprise a braided stent extending from a superior end to an inferior end of the corresponding endograft device, with the superior portions of the first and second endograft devices having covers extending from their superior ends and circumferentially enclosing the braid of the braided stent; and

sealing a septal wall of the superior portion of the first endograft device to a septal wall of the superior portion of the second endograft device such that a superior end of the septal wall of the first endograft device is longitudinally offset from a superior end of the septal wall of the second endograft when the outer walls of the superior portions of the first and second endograft devices are sealed to their respective first and second portions of the aorta.

23. The method of claim 22, further comprising:

advancing the first and second endograft devices to the aorta in a low-profile configuration, wherein the first and second endograft devices each comprise a braided frame having at least one anchor integrated with the braided frame such that the anchor retracts against the braided frame in the low-profile configuration; and

deploying the first and second endograft devices to an expanded configuration, wherein, upon expansion of the braided frames, the anchors self-deploy and project outwardly from the braided frames.

24. The method of claim 22 wherein:

the first endograft comprises a first cover on the braided frame of the first endograft device;

the second endograft comprises a second cover on the braided frame of the second endograft device;

the first and second covers each have a single layer of material; and

the first and second covers are sealed together at the septal walls of the superior portions of the first and second endograft devices.

25. The method of claim 22 wherein the cover of the first endograft device projects distally beyond the cover of the second endograft device by at least 5 mm.

26. The method of claim 22 wherein:

the step of positioning the superior portion of the first endograft device includes simultaneously positioning the braided stent and cover of the first endograft device together as a unit, and

the step of positioning the superior portion of the second endograft device includes simultaneously positioning the braided stent and cover of the second endograft device together as a unit.

27. A method of treating an aneurysm in an aorta of a human patient, the method comprising:

positioning at least a segment of a first superior portion of a first endograft device in the aorta before the aneurysm, wherein the first superior portion has a substantially D-shaped cross-section, and wherein the first endograft device comprises—

a first braided frame extending from a superior end of the first endograft device to an inferior end of the first endograft device, and

a first cover on the first braided frame, the first cover circumferentially enclosing at least a portion of the first braided frame and having an outer surface that substantially conforms to the first braided frame when the first braided frame is in an expanded state;

positioning at least a segment of a second superior portion of a second endograft device in the aorta before the aneurysm, wherein the second superior portion has a substantially D-shaped cross-section, and wherein the second endograft device comprises—

a second braided frame extending from a superior end of the second endograft device to an inferior end of the second endograft device, and

a second cover on the second braided frame, the second cover circumferentially enclosing at least a portion of the second braided frame and having an outer surface that substantially conforms to the second braided frame when the second braided frame is in an expanded state;

at least partially deploying the first superior portion of the first endograft device within the aorta, wherein, during deployment, the first endograft device expands to a first cross-sectional area via inherent outward spring force of the first braided frame;

constricting the first superior portion of the first endograft device to a second cross-sectional area less than the first-cross sectional area;

repositioning the first superior portion within the aorta while the first superior portion is constricted to the second cross-sectional area;

deploying the first superior portion of the first endograft device within the aorta after constriction; and

deploying the second superior portion of the second endograft device within the aorta such that the first and second superior portions form a sealed septum between the first and second endograft devices, and such that the first cover of the first endograft device at the septum extends superior to the second cover of the second endograft device at the septum after deployment.

28. The method of claim 27 wherein the first cover of the first endograft device extends superior to the second cover of the second endograft device by at least 5 mm.

29. The method of claim 27 wherein:

the step of positioning at least a segment of the first superior portion of the first endograft device includes simultaneously positioning the first braided frame and the first cover together; and

the step of positioning at least a segment of the second superior portion of the second endograft device includes simultaneously positioning the second braided frame and the second cover together.

30. A method of treating an aneurysm in an aorta of a human patient, the method comprising:

advancing a first endograft device through a left iliac artery of the patient;

advancing a second endograft device through a right iliac artery of the patient;

positioning a first superior portion of the first endograft device in the aorta proximate a right renal artery of the patient;

positioning a second superior portion of the second endograft device in the aorta proximate a left renal artery of the patient such that the first and second endograft devices cross each other within the aorta;

deploying the first endograft device such that at least a segment of the first superior portion seals with a right portion of the aorta proximate the right renal artery and a first inferior portion of the first endograft device seals to a portion of the left iliac artery; and

deploying the second endograft device such that at least a segment of the second superior portion seals with a left portion of the aorta proximate the left renal artery and a second inferior portion of the second endograft devices seals to a portion of the right iliac artery, and such that the second endograft device abuts the first at a septum, with one of the first and second endograft devices extending superiorly beyond the other of the first and second endograft devices at the septum after deployment.

31. A method of treating an aneurysm in an aorta of a human patient, the method comprising:

positioning a first superior portion of a first endograft device in the aorta proximate to the aneurysm, wherein the first superior portion has a first frame and a first graft material over the first frame, and wherein the first superior portion has a substantially D-shaped cross-section defined by a convexly curved first outer wall and a first septal wall;

positioning a second superior portion of a second endograft device in the aorta proximate to the aneurysm, wherein the second superior portion has a second frame and a second graft material over the second frame, and wherein the second superior portion has a substantially D-shaped cross-section defined by a convexly curved second outer wall and a second septal wall;

longitudinally staggering a superior terminus of the first graft material and a superior terminus of the second graft material such that the superior termini of the first and second graft material are longitudinally offset from each other along the first and second septal walls; and

sealing the longitudinally staggered first and second graft materials together at the first and second septal walls to form a sealed septum wherein the superior termini of the first and second graft material are longitudinally offset from each other along the first and second septal walls after the first and second graft materials are sealed together at the first and second septal walls.

32. The method of claim 31 wherein:

the first graft material substantially conforms with the first frame when the first frame is in an expanded state; and

the second graft material substantially conforms with the second frame when the second frame is in the expanded state.

33. The method of claim 31 wherein the superior termini of the first and second graft material are longitudinally offset from each other along the first and second septal walls by at least 5 mm.

34. The method of claim 31 wherein:

the step of positioning the first superior portion of the first endograft device includes simultaneously positioning the first frame and the first graft material together; and

the step of positioning the second superior portion of the second endograft device includes simultaneously positioning the second frame and the second graft material together.