Methods and devices for endovascular embolization

• US 9,681,876 B2
• Filed: 07/31/2014
• Issued: 06/20/2017
• Est. Priority Date: 07/31/2013
• Status: Active Grant

• Current Assignee: Embolic Acceleration, LLC
• Original Assignee: EMBA Medical Limited
• Inventors: Cragg, Andrew H., Logan, John, Naglreiter, Brett E., Green, Nicholas A., Gamez, Victor M., Arp, Scott R., Espinosa, Alejandro
• Primary Examiner(s): Anderson, Gregory
• Assistant Examiner(s): LAUER, CHRISTINA C
• Application Number:
  US14/449,037
• Publication Number:
  US 20150039017A1
• Time in Patent Office: 1,055 Days
• CPC Class Codes: A61B 17/12031 complete occlusion
• CPC Class Codes: A61B 17/12036 partial occlusion
• CPC Class Codes: A61B 17/12109 in a blood vessel
• 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 17/12177 comprising additional materials, e.g. thrombogenic, having filaments, having fibers or being coated
• CPC Class Codes: A61B 2017/00526 Methods of manufacturing
• CPC Class Codes: A61B 2017/00778 Operations on blood vessels A61B2017/22097, A61B2017/320741 take precedence
• CPC Class Codes: A61B 2017/00995 having a thin film
• CPC Class Codes: A61B 2017/1205 Introduction devices
• CPC Class Codes: A61B 2017/12054 Details concerning the detachment of the occluding device from the introduction device
• CPC Class Codes: A61B 2017/22082 after introduction of a substance
• CPC Class Codes: A61F 2/01 Filters implantable into blood vessels
• CPC Class Codes: A61F 2002/018 made from tubes or sheets of material, e.g. by etching or laser-cutting

Abstract

The present disclosure describes an occlusion device and methods of delivering the occlusion device. The occlusion device can include an expandable structure configured to move between an unexpanded configuration and an expanded configuration. The expandable structure can be configured to have an expansion ratio of at least about 5:1. Further, the occlusion device can be configured to prevent substantially all fluid from flowing past the occlusion device when the occlusion device is in the expanded configuration in the vessel.

Claims

1. An endovascular occlusion device, comprising:

a frame comprising a proximal embolic zone and a distal anchoring zone separated by a hub;

the proximal and distal zones self-expandable from a constrained diameter to an unconstrained diameter of at least about 500% of the constrained diameter;

a guidewire lumen through the hub, to permit placement over a guidewire; and

a valve in communication with the guidewire lumen,

wherein the valve comprises a collapsible tube extending from the hub into the proximal embolic zone, the collapsible tube being collapsible under blood pressure when the guidewire is removed from the hub.

2. The endovascular occlusion device as in claim 1, having an expansion ratio of at least about 6:

1.

3. The endovascular occlusion device as in claim 1, having an expansion ratio of at least about 7:

1.

4. The endovascular occlusion device as in claim 1, having an unconstrained expanded diameter of at least about 1.5 mm and which can be deployed from a 0.7 mm or smaller inside diameter lumen.

5. The endovascular occlusion device as in claim 1, having an unconstrained expanded diameter of at least about 6.0 mm and which can be deployed from a 0.7 mm or smaller inside diameter lumen.

6. The endovascular occlusion device as in claim 1, wherein the device is configured to occlude at least about 90 percent of flow through a vessel when the frame is in an expanded configuration.

7. The endovascular occlusion device of claim 1, wherein the hub is flexible to allow bending between the proximal and distal zones.

8. The endovascular occlusion device of claim 1, wherein the hub is a rigid tube.

9. The endovascular occlusion device of claim 1, wherein the hub is partially expandable.

10. An endovascular occlusion device for mechanical occlusion of blood flow in a vessel, comprising:

a support structure, expandable from a reduced cross section for transluminal navigation to an enlarged cross section for occluding a vessel;

an upstream lobe on the support structure, separated from a downstream lobe by a neck portion;

a guidewire lumen extending through the neck portion;

the upstream lobe comprising a concave configuration which is concave in a direction away from the downstream lobe;

a valve in the guidewire lumen the valve comprising a collapsible tube extending from the neck portion into the upstream lobe; and

a porous membrane carried by the upstream lobe,

wherein the upstream lobe occludes blood flow and the downstream lobe permits blood flow.

11. An endovascular occlusion device as in claim 10, wherein the occlusion device has an expansion ratio of at least about 5:

1.

12. An endovascular occlusion device as in claim 10, wherein the downstream lobe comprises a concave configuration, concave in a direction facing away from the upstream lobe.

13. An endovascular occlusion device as in claim 12, wherein the upstream lobe comprises a plurality of side wall struts.

14. An endovascular occlusion device as in claim 13, wherein the side wall struts carry the membrane.

15. An endovascular occlusion device deployment system, comprising the endovascular occlusion device of claim 14, oriented on an elongate, flexible deployment catheter having a proximal end and a distal end such that the upstream lobe faces the proximal end of the catheter.

16. An endovascular occlusion device as in claim 10, wherein the downstream lobe comprises a plurality of side wall struts.

17. An endovascular occlusion device as in claim 10, wherein following deployment in an artery with the upstream lobe in an anatomically proximal orientation, blood pressure on the concave side of the upstream lobe generates a radially outward force from the upstream lobe against the artery wall.

18. An endovascular occlusion device as in claim 17, wherein blood pressure on the concave side of the upstream lobe generates an axially distal force on the neck portion.

19. An endovascular occlusion device as in claim 10, having an expansion ratio of at least about 6:

1.

20. An endovascular occlusion device as in claim 10, having an expansion ratio of at least about 7:

1.

21. An endovascular occlusion device as in claim 10, having an unconstrained expanded diameter of at least about 6.0 mm and which can be deployed from a 1 mm or smaller inside diameter lumen.

22. An endovascular occlusion device as in claim 10, wherein the device is configured to occlude at least about 90 percent of flow through a vessel when the support structure is in an expanded configuration.

23. An endovascular occlusion device as in claim 10, configured to achieve a reduction in blood flow of at least about 80% within 2 minutes of deployment in a blood vessel.

24. An endovascular occlusion device as in claim 23, configured to achieve a reduction in blood flow of at least about 80% within 1 minute of deployment in a blood vessel.

25. An endovascular occlusion device as in claim 24, configured to achieve total occlusion within 5 minutes of deployment in a blood vessel.

26. An endovascular occlusion device as in claim 25, configured to achieve total occlusion within 1 minute of deployment in a blood vessel.