VASCULAR REMODELING DEVICE

• US 20120290067A1
• Filed: 05/11/2012
• Published: 11/15/2012
• Est. Priority Date: 05/11/2011
• Status: Active Grant

• Current Assignee: Covidien LP (Medtronic Plc)
• Original Assignee: Tyco Healthcare Group LP (Medtronic Plc)
• Inventors: Cam, Anh, Losordo, Michael Louis, Ma, Jianlu, Zhao, Xiaoling
• Granted Patent: US 8,956,399 B2
• Time in Patent Office: Days
• US Class Current: 623/1.12
• CPC Class Codes: A61B 17/12031 complete occlusion
• 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: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/844 folded prior to deployment
• 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 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/915 with bands having a meander structure, adjacent bands being connected to each other
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/954 for placing stents or stent-grafts in a bifurcation
• CPC Class Codes: A61F 2/966 with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
• 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 2002/821 Ostial stents
• CPC Class Codes: A61F 2002/823 Stents, different from stent-grafts, adapted to cover an aneurysm
• CPC Class Codes: A61F 2230/0076 ellipsoidal or ovoid
• CPC Class Codes: A61F 2240/001 Designing or manufacturing processes
• CPC Class Codes: A61F 2250/0039 differing in diameter
• CPC Class Codes: Y10T 29/4998 Combined manufacture including applying or shaping of fluent material

Abstract

Described herein are flexible implantable devices or stents that can conform to the shape of vessels of the neurovasculature. In some embodiments, the devices can direct blood flow within a vessel away from an aneurysm or limit blood flow to the aneurysm. In some embodiments, a vascular remodeling device includes a first section and a protruding section. During deployment, the device expands from a compressed configuration to an expanded configuration. The first section anchors the device in an afferent vessel and/or in an efferent vessel of a bifurcation and the protruding section is positioned in the junction of the bifurcation having an aneurysm and across the neck of the aneurysm or at least partially within the aneurysm.

Claims

1. A vascular stent, comprising:

a proximal section having a first cross-sectional dimension and being configured to anchor in an afferent vessel of a bifurcation proximate to an aneurysm, the proximal section comprising a tubular shape that defines a proximal lumen;

a distal section having a second cross-sectional dimension and being configured to be positioned in an efferent vessel of the bifurcation, the distal section comprising a tubular shape that defines a distal lumen; and

a protruding section, between the proximal and distal sections, having a third cross-sectional dimension, the protruding section (i) being configured to abut an ostium of the aneurysm when the protruding section is positioned at the bifurcation, (ii) defining an intermediate lumen in fluid communication with the proximal and distal lumens, and (iii) having a strut pattern that is substantially the same as strut patterns of the proximal and distal sections;

wherein the proximal, distal and protruding sections are expandable from a compressed configuration to an expanded configuration.

2. The stent of claim 1, wherein the protruding section is configured to inhibit dislodgment of objects out of the aneurysm.

3. The stent of claim 1, wherein the strut patterns of the proximal, distal, and protruding sections define substantially similar cell sizes.

4. The stent of claim 1, wherein cell sizes of the strut pattern in the protruding section are configured to allow perfusion of fluid to efferent vessels.

5. The stent of claim 1, wherein the proximal, distal, and protruding sections comprise nonuniform cross-sectional dimensions when the stent is unconstrained.

6. The stent of claim 1, wherein the protruding section comprises an irregular-shaped cross-section.

7. The stent of claim 1, wherein the protruding section is expandable to a further expanded configuration, the further expanded configuration defining a fourth cross-sectional dimension greater than the third cross-sectional dimension.

8. The stent of claim 1, wherein the proximal, distal, and protruding sections comprise woven filaments.

9. The stent of claim 1, wherein at least one of the proximal, distal, and protruding sections is self-expandable.

10. The stent of claim 1, wherein at least one of the proximal and distal sections comprises a first material and the protruding section comprises a second material different from the first material.

11. The stent of claim 1, further comprising (i) a first intermediate section, between the proximal and protruding sections, having a first taper, from the proximal section to the protruding section, and (ii) a second intermediate section, between the distal and protruding sections, having a second taper, from the distal section to the protruding section, the first taper having a different degree of tapering than the second taper.

12. The stent of claim 11, wherein the second taper has a steeper degree of tapering than does the first taper.

13. The stent of claim 1, wherein the protruding section bulges radially outward along substantially an entire circumference of the device.

14. The stent of claim 1, wherein a bulge of the protruding section provides a generally asymmetrical profile.

15. The stent of claim 1, wherein at least a portion of the protruding section comprises a lower filament density than at least one of another portion of the protruding section, the proximal section, and the distal section.

16. A method of treating an aneurysm at a junction of a bifurcation having first and second efferent vessels, comprising:

advancing a catheter to the first efferent vessel of the bifurcation;

advancing, relative to and within the catheter, a stent in a compressed configuration, the stent comprising (i) a proximal section having a first cross-sectional dimension and a tubular shape that defines a proximal lumen, (ii) a distal section having a second cross-sectional dimension and a tubular shape that defines a distal lumen; and

(iii) a protruding section, between the proximal and distal sections, having a third cross-sectional dimension and defining an intermediate lumen in fluid communication with the proximal and distal lumens, the protruding section having a strut pattern that is substantially the same as struts patterns of the proximal and distal sections;

expanding, to an expanded configuration, the proximal and distal sections to anchor the stent in the efferent and an afferent vessel; and

expanding the protruding section at the bifurcation, such that the protruding section abuts an ostium of the aneurysm and inhibits dislodgment of objects out of the aneurysm;

wherein, after the expanding steps, the proximal, intermediate, and distal lumens provide a substantially unobstructed path for fluid flow from the afferent vessel to the first efferent vessel and the strut pattern of the protruding section permits fluid flow to the second efferent vessel.

17. The method of claim 16, wherein at least one of the proximal, distal, and protruding sections self-expands.

18. The method of claim 16, further comprising withdrawing the stent at least partially back into the catheter after a portion of the stent has been advanced out of the catheter.

19. The method of claim 16, further comprising inserting embolic material into the aneurysm.

20. The method of claim 19, wherein the embolic material is inserted into the aneurysm before sections of the stent are expanded.

21. The method of claim 19, wherein the embolic material is inserted into the aneurysm after sections of the stent are expanded.

22. The method of claim 21, wherein the embolic material is inserted into the aneurysm through a wall of the stent defined by the strut pattern of the protruding section.

23. A method of manufacturing a vascular device, comprising:

forming a substantially tubular stent having a substantially similar strut pattern throughout the stent;

shape setting the stent to form (i) a proximal section having a first cross-sectional dimension and a proximal lumen and (ii) a distal section having a second cross-sectional dimension and a distal lumen; and

shape setting the stent to form a protruding section, between the proximal and distal sections, having a third cross-sectional dimension greater than the first and second cross-sectional dimensions, wherein the proximal section is configured to anchor in an afferent vessel of a bifurcation comprising an aneurysm, the protruding section is configured to be positioned at the bifurcation and to act as a scaffolding to inhibit dislodgment of objects out of the aneurysm by abutting an ostium of the aneurysm, and the distal section is configured to be positioned in an efferent vessel of the bifurcation;

wherein the proximal, intermediate, and distal lumens are configured to provide a substantially unobstructed fluid flow path from the afferent vessel to the efferent vessel.

24. The method of claim 23, wherein the forming comprises cutting a tube.

25. The method of claim 23, wherein the forming comprises cutting a sheet and shape setting the sheet into a substantially tubular shape.

26. The method of claim 23, wherein the forming comprises weaving a plurality of wires and shape setting the plurality of wires into a substantially tubular shape.

27. The method of claim 23, wherein the strut pattern defines substantially similar cell sizes.

28. The method of claim 23, further comprising shape setting (i) a first intermediate section, between the proximal and protruding sections, having a first taper, from the proximal section to the protruding section, and (ii) a second intermediate section, between the distal and protruding sections, having a second taper, from the distal section to the protruding section, the first taper having a different degree of tapering than the second taper.

29. The method of claim 28, wherein the second tapered portion is formed to have a steeper degree of tapering than does the first tapered portion.