Vascular remodeling device

• US 9,179,918 B2
• Filed: 07/21/2009
• Issued: 11/10/2015
• Est. Priority Date: 07/22/2008
• Status: Active Grant

• Current Assignee: Covidien LP (Medtronic Plc)
• Original Assignee: Covidien LP (Medtronic Plc)
• Inventors: Levy, Elad Israel, Slee, Earl, Shrivastava, Sanjay, Schuman, Victoria, Huynh, Andy, Lu, Wenfeng
• Primary Examiner(s): PELLEGRINO, BRIAN E
• Application Number:
  US12/506,945
• Publication Number:
  US 20100023105A1
• Time in Patent Office: 2,303 Days
• Field of Search: 606/151, 606/191, 606/194, 606/198, 606/200, 623/1.11, 623/1.35, 623/902, 623/903
• US Class Current: 1/1
• 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;

expanding the device from the compressed state to an uncompressed state at the junction of the bifurcation;

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, wherein the device permits perfusion of fluid to the efferent vessels, and

after the expanding the device, the withdrawing the catheter, and the leaving the device, inserting the objects in the fundus of the aneurysm, the objects comprising coils;

wherein the device comprises a first filament junction and a second filament junction substantially opposite to the first filament junction along a longitudinal axis, and a plurality of filaments, each of the plurality of filaments comprising a middle segment extending an entire distance from the first filament junction to the second filament junction, the middle segments forming the entirety of a generally spherical shape, each of the plurality of filaments having a first end region and a second end region, the first end regions coupled to each other forming the first filament junction, and the second end regions coupled to each other forming the second filament junction;

wherein the device further comprises a first sleeve around the first end regions at the first filament junction and extending outside an outer periphery of the generally spherical shape along the longitudinal axis;

wherein the device further comprises a second sleeve around the second end regions at the second filament junction and extending outside the outer periphery of the generally spherical shape along the longitudinal axis;

wherein the middle segments are unattached to one another between the first filament junction and the second filament junction; and

wherein, when the device is left at the bifurcation junction after the expanding, the plurality of filaments extend continuously in a direction along the longitudinal axis from the first end region to the second end region, with no longitudinal reversal of direction.

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 bifurcation.

4. The method of claim 1, wherein the plurality of filaments comprise a self-expanding or a shape-memory material and wherein expanding the device comprises allowing the device to expand towards the uncompressed state.

5. The method of claim 1, further comprising releasing the device from the catheter after expanding the device.

6. The method of claim 5, wherein releasing the device comprises mechanically releasing the device from the catheter.

7. The method of claim 5, wherein releasing the device comprises electrolytically releasing the device from the catheter.

8. The method of claim 5, further comprising:

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

redeploying the device from the catheter; and

re-expanding the device.

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

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

11. 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, the device comprising;

a plurality of filaments having (i) a plurality of middle segments, each having an entire length extending from a proximal end to a distal end, the proximal end and the distal end extending outwardly to form a generally spherical shape having an outer periphery, the plurality of middle segments being unattached to each other between the proximal ends to the distal ends (ii) a plurality of proximal segments proximal to the middle segments and being coupled together at the proximal location outside the outer periphery of the generally spherical shape, and (iii) a plurality of distal segments distal to the middle segments and being coupled together at the distal location outside the outer periphery of the generally spherical shape and substantially opposite to the proximal location along a longitudinal axis of the device;

a proximal sleeve positioned around the plurality of proximal segments at the proximal location; and

a distal sleeve positioned around the plurality of distal segments at the distal location;

expanding the device from the compressed state to an uncompressed state at the junction of the bifurcation;

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

after expanding the device, withdrawing the catheter, and leaving the device at the junction of the bifurcation, inserting the embolic coils through the device and into the fundus of the aneurysm.

12. The method of claim 11, wherein the device is substantially devoid of a covering, mesh, or other material between the filaments, thereby allowing fluid to flow substantially unimpeded there through.

13. The method of claim 11, wherein each of the filaments has a substantially rectangular cross section.

14. The method of claim 11, wherein the generally spherical shape is a twisted sphere.

15. The method of claim 14, wherein the twisted sphere is formed by the proximal end relative to the distal end.