Endoluminal device having enhanced affixation characteristics

• US 20060100684A1
• Filed: 12/27/2005
• Published: 05/11/2006
• Est. Priority Date: 02/26/2003
• Status: Active Grant

• Current Assignee: Lifeshield Sciences LLC (Acacia Research Corporation)
• Original Assignee: Lifeshield Sciences LLC (Acacia Research Corporation)
• Inventors: Elliott, Christopher J.
• Granted Patent: US 8,663,316 B2
• Time in Patent Office: Days
• US Class Current: 623/1.200
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/848 having means for fixation to the vessel wall, e.g. barbs
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2002/065 Y-shaped blood vessels
• CPC Class Codes: A61F 2002/077 having means to fill the space between stent-graft and aneurysm wall, e.g. a sleeve
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0071 spherical
• CPC Class Codes: A61F 2230/0076 ellipsoidal or ovoid
• CPC Class Codes: A61F 2230/008 paraboloidal
• CPC Class Codes: A61F 2250/0039 differing in diameter

Abstract

An endoluminal device for affixation to a wall of a body lumen having a neck region defined by a relatively narrow width and a shoulder region that diverges from the neck region to a relatively wider width. The device comprises a bulbous portion having a shoulder portion with a diameter profile that conforms to the shoulder region of the lumen, and a converging diameter portion sized not to conform to the body lumen diameter profile. In some embodiments, a plurality of affixation members in an area of the device that typically extends from a distal end of the device through the shoulder portion. In one embodiment, the device comprises an endograft for repair of an aneurysm, such as an abdominal aortic aneurysm (AAA).

Claims

1. An endoluminal device for affixation to a wall of a body lumen, the body lumen having a neck region defined by a relatively narrow width and a lumen shoulder region that diverges from the neck region to a relatively wider width, the device comprising a device shoulder portion, comprising part of a bulbous portion, and a device neck located adjacent the bulbous portion, the device shoulder portion having a device diameter profile sized to conform to a lumen diameter profile of the shoulder region for deployment in the shoulder region, the device neck having a first diameter, and the bulbous portion having a length characterized by a diverging and converging diameter greater than the first diameter along the bulbous portion length, the device having a diameter profile in said converging diameter part of said bulbous portion length sized not to conform to the body lumen diameter profile.

2. The endoluminal device of claim 1, wherein the device comprises a compressed configuration and a radially expanded configuration, the device neck having a first radial self-expansion force and the device shoulder portion having a second radial self-expansion force less than the first radial expansion force.

3. The device of claim 1, wherein the bulbous portion of the device comprises a stent having at least one superelastic section and at least one plastically deformable section.

4. The device of claim 1 further comprising a plurality of affixation members at least on part of the device shoulder portion.

5. The endoluminal device of claim 4, wherein the affixation members comprise hooks, barbs, or other members that project radially outward from the device.

6. The endoluminal device of claim 4, wherein the device has a distal end adapted to be positioned in an upstream portion of the lumen and the plurality of affixation members are disposed in an area of the device extending proximally from the distal end of the device through the device shoulder portion.

7. The endograft of claim 6, wherein the area in which the plurality of affixation members are disposed extends axially to a maximum diameter portion of the device shoulder portion.

8. The endoluminal device of claim 1, wherein the device comprises a stent.

9. The device of claim 8, wherein the stent comprises at least one superelastic section and at least one plastically deformable section.

10. The device of claim 1, wherein the shoulder portion of the device comprises a stent having at least one superelastic section and at least one plastically deformable section.

11. The endoluminal device of claim 1, wherein the device comprises an endograft comprising a stent that is at least partially covered or lined with a graft material.

12. The endoluminal device of claim 11, wherein the endograft is adapted to repair an aneurysm.

13. The endoluminal device of claim 12, wherein the endograft is adapted to repair an abdominal aortic aneurysm (AAA).

14. The endoluminal device of claim 13, wherein the neck region includes a renal neck at a distal end of the aneurysm and the device shoulder portion is positioned proximal the renal neck at the lumen shoulder region.

15. The endoluminal device of claim 13, wherein the neck region includes an iliac neck at a proximal end of the aneurysm and the device shoulder portion is positioned distally of the iliac neck.

30. The endograft of claim 1, wherein the device converging diameter length comprises a tapered or step-change diameter.

16. An endoluminal device adapted to repair an abdominal aortic aneurysm (AAA) for affixation to a wall of a body lumen, the body lumen having a renal neck region, defined by a relatively narrow width, and a renal shoulder region that diverges from the renal neck region at a distal end of the aneurysm and an iliac neck region, defined by a relatively narrow width, and an iliac shoulder region that diverges from the iliac neck region at a proximal end of the aneurysm, the device comprising:

a device distal shoulder portion, the device distal shoulder portion having a diameter profile sized to conform to the renal shoulder region for deployment in the renal shoulder region;

one or more device proximal shoulder portions, each device proximal shoulder portions for deployment in the iliac shoulder region, each device proximal shoulder portion having a diameter profile sized to conform to the corresponding iliac shoulder region, wherein the distal shoulder portion is part of a distal bulbous portion and each of the one or more proximal shoulder portions are part of a corresponding proximal bulbous portion; and

a device neck corresponding to each shoulder portion located adjacent each bulbous portion, each device neck having a first diameter, and each bulbous portion having a length characterized by a diverging and converging diameter greater than its corresponding first diameter along each bulbous portion length, the device having a diameter profile in each of said converging diameter part of said bulbous length sized not to conform to the body lumen diameter profile.

17. The device of claim 16 further comprising a plurality of affixation members at least on part of the device distal shoulder portion and on part of the one or more device proximal shoulder portions.

18. The endoluminal device of claim 16, wherein the device distal shoulder portion and the one or more device proximal shoulder portions comprise a non-modular device.

19. The endoluminal device of claim 16, wherein the device distal shoulder portion and the one or more device proximal shoulder portions comprise a modular device.

20. The endoluminal device of claim 19, wherein a first modular component comprises the device distal shoulder portion and a first device proximal shoulder portion, and a second modular component comprises a second device proximal shoulder portion.

21. An endograft for repair of an abdominal aortic aneurysm (AAA) having a lumen wall, the endograft comprising a stent at least partially lined or covered by a graft material and having a distal end comprising a distal neck having a first diameter and a first bulbous portion located proximally of the distal neck and having a proximally diverging then converging diameter greater than the first diameter, the endograft having a diameter profile in said converging diameter part of said bulbous portion length sized not to conform to the body lumen diameter profile, at least the distal neck and part of the first bulbous portion comprising a plurality of affixation members that project radially outward from the device for affixation to the lumen wall of the AAA.

22. The endograft of claim 21, wherein the plurality of affixation members are disposed in an area that extends axially from a distal end of the endograft to at least an intermediate location in the first bulbous portion.

23. The endograft of claim 22, wherein the area in which the plurality of affixation members are disposed extends axially to a maximum diameter portion of the first bulbous portion.

24. The endograft of claim 21 having a compressed configuration and a radially expanded configuration, the device neck having a first radial self-expansion force and the first bulbous portion having a second radial self-expansion force less than the first radial self-expansion force.

25. The endograft of claim 21 further comprising a proximal end comprising at least one proximal neck having a second diameter and an additional corresponding bulbous portion located distally of the proximal neck and having a distally diverging then converging diameter greater than the second diameter, at least the proximal neck and part of the additional corresponding bulbous portion comprising a plurality of affixation members that project radially outward from the device for affixation to the lumen wall of the AAA.

26. The endograft of claim 25 comprising two proximal necks and two additional corresponding bulbous portions, each proximal neck and additional corresponding bulbous portion for deployment adjacent an iliac neck region of the AAA.

27. The endograft of claim 25, wherein the distal neck and first bulbous portion comprise a first modular component and the proximal neck and additional corresponding bulbous portion comprises a second modular component.

28. The endograft of claim 26, wherein the distal neck and first bulbous portion comprise a first modular component, and each proximal neck and additional corresponding bulbous portion comprise additional modular components.

29. The endograft of claim 26, wherein the distal neck, first bulbous portion, one proximal neck, and one additional corresponding bulbous portion comprise a first modular component, and another proximal neck and additional corresponding bulbous portion comprise a second modular component.