VASCULAR REMODELING DEVICE

• US 20100023105A1
• Filed: 07/21/2009
• Published: 01/28/2010
• Est. Priority Date: 07/22/2008
• Status: Active Grant

• Current Assignee: Covidien LP (Medtronic Plc)
• Original Assignee: Micro Therapeutics, Inc. (Medtronic Plc)
• Inventors: Shrivastava, Sanjay, Slee, Earl, Lu, Wenfeng, Schuman, Victoria, Levy, Elad Israel, Huynh, Andy
• Granted Patent: US 9,179,918 B2
• Time in Patent Office: Days
• US Class Current: 623/1.200
• CPC Class Codes: A61B 17/12022 Occluding by internal devices, e.g. balloons or releasable wires plugging an opening in the wall of an organ A61B17/0057; occluders for the cervical canal A61F6/146; vas deferens occluders A61F6/20
• CPC Class Codes: A61B 17/12113 within an aneurysm
• CPC Class Codes: A61B 17/12118 for positioning in conjunction with a stent
• CPC Class Codes: A61B 17/1214 Coils or wires
• CPC Class Codes: A61B 17/12172 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 2017/12054 Details concerning the detachment of the occluding device from the introduction device
• CPC Class Codes: A61B 2017/12063 electrolytically detachable
• CPC Class Codes: A61F 2/86 Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/954 for placing stents or stent-grafts in a bifurcation
• CPC Class Codes: A61F 2002/065 Y-shaped blood vessels
• CPC Class Codes: A61F 2002/823 Stents, different from stent-grafts, adapted to cover an aneurysm
• CPC Class Codes: A61F 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0071 spherical

Abstract

A generally spherical vascular remodeling device is permanently positionable at a junction of afferent and efferent vessels of a bifurcation having an aneurysm. After positioning the device at the junction to substantially conform the device to the shape of the junction, the device acts as a scaffolding to inhibit herniation of objects out of the aneurysm and the device permits perfusion to the efferent vessels. Positioning the device may include deployment and mechanical or electrolytic release from a catheter. Embolic material may be inserted in the aneurysm before or after positioning the device. The device may have a first end, a second end substantially opposite to the first end, and a plurality of filaments extending between and coupled at the first end and the second end. Such devices may be football shaped, pumpkin shaped, or twisted. The device may include a plurality of loops forming a generally spherical shape.

Claims

1. A method of treating an aneurysm at a bifurcation having an afferent vessel and efferent vessels having a junction, the aneurysm having a neck and a fundus, the method comprising:

advancing a catheter proximate to the junction of the bifurcation, the catheter at least partially containing a generally spherical vascular remodeling device in a compressed state;

positioning the device at the junction of the bifurcation; and

withdrawing the catheter and leaving the device at the junction of the bifurcation, wherein the device acts as a scaffolding to inhibit herniation of objects out of the neck of the aneurysm and wherein the device permits perfusion of fluid to the efferent vessels.

2. The method of claim 1, wherein the bifurcation is a neurovascular bifurcation.

3. The method of claim 1, wherein the device substantially conforms to a shape of the junction.

4. The method of claim 1, wherein positioning the device comprises:

deploying the device from the catheter; and

expanding the device.

5. The method of claim 4, wherein the device comprises a plurality of filaments comprising a self-expanding or a shape-memory material and wherein expanding the device comprises allowing the device to expand towards an uncompressed state.

6. The method of claim 4, wherein positioning the device further comprises, after expanding the device, releasing the device from the catheter.

7. The method of claim 6, wherein releasing the device comprises mechanically releasing the device from the catheter.

8. The method of claim 6, wherein releasing the device comprises electrolytically releasing the device from the catheter.

9. The method of claim 6, further comprising:

after expanding the device, retracting the device into the catheter;

redeploying the device from the catheter; and

re-expanding the device.

10. The method of claim 1, further comprising, after positioning the device, inserting embolic material in the fundus of the aneurysm, the objects comprising the embolic material.

11. The method of claim 1, further comprising, before positioning the device, inserting embolic material in the fundus of the aneurysm, the objects comprising the embolic material.

12. The method of claim 1, wherein a ratio of fundus width to neck width is greater than about 2 to 1.

13. The method of claim 1, wherein neck width is greater than about 4 mm.

14. A generally spherical remodeling device comprising:

a first end;

a second end substantially opposite to the first end; and

a plurality of filaments extending between the first end and the second end and coupled at the first end and the second end,

wherein the device is configured

to be positioned at a junction of a neurovascular bifurcation comprising at least one afferent vessel, efferent vessels, and an aneurysm having a neck,

to act as a scaffolding to inhibit herniation of objects out of the neck of the aneurysm, and

to permit perfusion of fluid to the efferent vessels.

15. The device of claim 14, wherein the device is generally football-shaped, the first end extending outwardly and the second end extending outwardly.

16. The device of claim 14, wherein the device is generally pumpkin-shaped, the first end extending outwardly and the second end extending inwardly.

17. The device of claim 14, wherein the filaments comprise shape-memory material.

18. The device of claim 14, wherein at least one of the filaments comprises a radiopaque material.

19. The device of claim 14, wherein at least one of the filaments comprises a radiopaque material at least partially wrapped around a self-expanding material.

20. The device of claim 14, wherein at least one of the filaments comprises a self-expanding material with a radiopaque core or a radiopaque coating.

21. The device of claim 14, wherein porosity distally increases between the second end and an approximate midpoint and wherein porosity distally decreases between the midpoint and the first end.

22. The device of claim 14, wherein the filaments are longitudinally angled at the second end.

23. The device of claim 14, further comprising a radiopaque marker proximate to at least one of the first end and the second end.

24. The device of claim 14, further comprising a first radiopaque marker proximate to the first end and a second radiopaque marker proximate to the second end.

25. The device of claim 14, wherein the plurality of filaments comprises between about 6 filaments and about 12 filaments.

26. A remodeling device comprising a plurality of loops forming a generally spherical shape, wherein the device is configured to be positioned at a junction of a neurovascular bifurcation having an aneurysm, wherein the device is configured to act as a scaffolding to inhibit matter from herniating out of the aneurysm, and wherein the device is configured to permit perfusion of blood to efferent vessels of the bifurcation.