VASCULAR REMODELING DEVICE

• US 20120143237A1
• Filed: 12/06/2011
• Published: 06/07/2012
• Est. Priority Date: 12/06/2010
• Status: Active Grant

• Current Assignee: Covidien LP (Medtronic Plc)
• Original Assignee: Tyco Healthcare Group LP (Medtronic Plc)
• Inventors: SHRIVASTAVA, Sanjay, CAM, Anh, LOSORDO, Michael Louis, MA, Jianlu, NGUYEN, Luong, WAINWRIGHT, John, ZHAO, Xiaoling
• Granted Patent: US 8,915,950 B2
• Time in Patent Office: Days
• US Class Current: 606/194
• 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 17/12145 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 17/12168 having a mesh structure A61B17/1214 takes precedence
• CPC Class Codes: A61B 17/12172 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 2017/00867 shape memory effect
• CPC Class Codes: A61B 2017/1209 detachable by electrical current or potential, e.g. electroactive polymer
• 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 2/966 with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
• CPC Class Codes: A61F 2002/823 Stents, different from stent-grafts, adapted to cover an aneurysm
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• CPC Class Codes: A61F 2230/0034 D-shaped
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0069 cylindrical
• CPC Class Codes: A61F 2230/0093 Umbrella-shaped, e.g. mushroom-shaped

Abstract

Described herein are vascular remodeling devices that include a proximal section, an intermediate section, and a distal section. During deployment, the proximal section can expand from a compressed delivery state to an expanded state and anchors the device in an afferent vessel of a bifurcation. The distal section expands from the compressed delivery state to an expanded state that may be substantially planar, approximately semi-spherical, umbrella shaped, or reverse umbrella shaped. The distal section is positioned in a bifurcation junction across the neck of an aneurysm or within an aneurysm. The intermediate section allows perfusion to efferent vessels. Before or after the device is in position, embolic material may be used to treat the aneurysm. The distal section can act as a scaffolding to prevent herniation of the embolic material. The device can be used for clot retrieval with integral distal embolic protection.

Claims

1. A method of treating an aneurysm at a junction of a bifurcation having an afferent vessel and efferent vessels, 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 device in a compressed state, the device comprising;

a proximal section configured to anchor in an afferent vessel;

an intermediate section configured to allow perfusion to efferent vessels; and

a distal section configured to act as a scaffolding to inhibit herniation of objects out of a neck of a bifurcation aneurysm;

expanding the distal section from the compressed state to a radially expanded state at the junction of the bifurcation, wherein a distal end of the distal section moves radially outwardly and proximally relative to the proximal section, and a proximal end of the distal section moves radially inwardly and distally relative to the proximal section.

2. The method of claim 1, further comprising expanding the proximal section within an afferent vessel proximal to the bifurcation after expanding the distal section.

3. The method of claim 1, further comprising inserting embolic material into the aneurysm.

4. The method of claim 3, wherein inserting the embolic material comprises inserting the embolic material from the catheter.

5. The method of claim 3, wherein inserting the embolic material comprises inserting the material through a lumen defined by the expanded distal section.

6. The method of claim 3, wherein inserting the embolic material is before expanding the distal section.

7. The method of claim 3, wherein inserting the embolic material is after expanding the distal section.

8. The method of claim 3, wherein inserting the embolic material is during expanding the distal section.

9. The method of claim 3, wherein inserting the embolic material comprises inserting embolic coils.

10. The method of claim 3, wherein inserting the embolic material comprises inserting embolic fluid.

11. The method of claim 1, further comprising retrieving the distal section at least partially back into the catheter, and redeploying the distal section.

12. The method of claim 1, wherein expanding the distal section comprises releasing the device from the catheter.

13. The method of claim 12, wherein releasing the device from the catheter comprises mechanical detachment.

14. The method of claim 12, wherein releasing the device from the catheter comprises electrolytic detachment.

15. The method of claim 1, wherein the aneurysm comprises a basilar tip aneurysm.

16. The method of claim 1, wherein the intermediate section comprises a plurality of struts and wherein each of the plurality of struts comprises a distal portion coupled, at a coupling, to the distal section at a region between a proximal end of the distal section and a distal end of the distal section.

17. The method of claim 16, wherein, while expanding the distal section, the distal portion moves radially outwardly to define, when expanded, an outermost cross-sectional dimension that is greater than an outermost cross-sectional dimension of the proximal section.

18. The method of claim 16, wherein, while expanding the distal section, the proximal portion moves to an axial location substantially aligned with the coupling.

19. The method of claim 16, wherein, while expanding the distal section, the proximal portion moves radially inwardly to define, when expanded, an innermost cross-sectional dimension that is less than an innermost cross-sectional dimension of the proximal section.

20. The method of claim 16, wherein, while expanding the distal section, the proximal portion defines a first lumen sized smaller than a second lumen defined by the proximal section.

21. The method of claim 16, wherein, while expanding the distal section, the distal section pivots about the coupling to expand radially.

22. The method of claim 16, wherein, while expanding the distal section, (i) a distal portion of the distal section is configured to move radially inwardly and proximally relative to the coupling and (ii) a proximal portion of the distal section is configured to move radially outwardly and distally relative to the coupling.

23. The method of claim 22, wherein, while expanding the distal section, the proximal portion moves radially outwardly to define, when expanded, an outermost cross-sectional dimension that is greater than an outermost cross-sectional dimension of the proximal section.

24. The method of claim 22, wherein, while expanding the distal section, the distal portion moves radially inwardly to define, when expanded, an innermost cross-sectional dimension that is less than an innermost cross-sectional dimension of the proximal section.

25. The method of claim 22, wherein, while expanding the distal section, the distal portion defines a first lumen sized smaller than a second lumen defined by the proximal section.

26. The method of claim 22, wherein the distal section pivots about the coupling when expanding the distal section.

27. The method of claim 1, wherein the distal section is expanded within the aneurysm.

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

advancing a catheter proximate to the junction of the bifurcation, the catheter at least partially containing a device in a compressed state, the device comprising;

a proximal section configured to anchor in an afferent vessel;

an intermediate section comprising a plurality of struts configured to allow perfusion to efferent vessels; and

a distal section configured to act as a scaffolding to inhibit herniation of objects out of a neck of a bifurcation aneurysm;

wherein each of the plurality of struts comprises a distal portion coupled, at a joint, to the distal section at a region of the distal section between a proximal end of the distal section and a distal end of the distal section;

expanding the distal section from the catheter at the junction of the bifurcation, wherein each of the proximal end and the distal end pivots about the joint, such that the distal section at least partially everts.

29. The method of claim 28, further comprising releasing the proximal section from the catheter, whereby the proximal section self-expands to conform to the afferent vessel;

and

30. The method of claim 28, further comprising inserting embolic material into the aneurysm.

31. The method of claim 30, wherein inserting the embolic material is before deploying the distal section.

32. The method of claim 30, wherein inserting the embolic material is after deploying the distal section.

33. The method of claim 30, wherein inserting the embolic material is during deploying the distal section.

34. The method of claim 30, wherein inserting the embolic material comprises inserting embolic coils.

35. The method of claim 30, wherein inserting the embolic material comprises inserting embolic fluid.

36. The method of claim 28, further comprising retrieving the distal section at least partially back into the catheter and subsequently expanding the distal section a second time.

37. The method of claim 28, wherein expanding the distal section comprises releasing the device from the catheter.

38. The method of claim 37, wherein releasing the device from the catheter comprises mechanical detachment.

39. The method of claim 37, wherein releasing the device from the catheter comprises electrolytic detachment.

40. The method of claim 30, wherein inserting the embolic material comprises deploying the embolic material from the catheter.

41. The method of claim 28, wherein the aneurysm comprises a basilar tip aneurysm.

42. The method of claim 28, wherein the distal section is expanded within the aneurysm.