METHODS AND DEVICES FOR ENDOVASCULAR EMBOLIZATION

1 . A vascular 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.

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 expandable tubular frame is in an expanded configuration.

7 . An endovascular occlusion device, comprising an expandable occlusive element for expansion within and occlusion of a vessel, the occlusive element having an expansion ratio of at least about 5:1.

8 . A delivery system for delivering an occlusion device, the delivery system comprising:

an outer catheter;

an inner catheter axially movable within the outer catheter, the inner catheter configured to deliver the occlusion device out of the outer catheter, wherein the occlusion device comprises:

an expandable structure configured to move between an unexpanded configuration and an expanded configuration, the expandable structure having a proximal portion, a middle portion, and a distal portion,

wherein the expandable structure has an expansion ratio of at least about 5:1,

and wherein the occlusion device is configured to prevent substantially all fluid from flowing past the occlusion device when the occlusion device is in the expanded configuration in the vessel.

9 . The delivery system of claim 8 , further comprising a support tube axially disposed between the outer catheter and the inner catheter.

10 . The delivery system of claim 8 , wherein the outer catheter includes an inner diameter of less than or equal to about 2 mm.

11 . The delivery system of claim 8 , wherein the inner catheter is configured to carry the expandable structure on a distal portion of the inner catheter.

12 . The delivery system of claim 8 , wherein the inner catheter releasably engages at least one of the proximal end or the distal end of the expandable structure.

13 . A method of occluding a vessel, the method comprising:

advancing a delivery system over a guidewire in the vessel;

deploying a single occlusion device from the delivery system, the single occlusion device having at least one closed end and an occlusive membrane extending across at least the closed end, wherein the single occlusion device has an expansion ratio of at least about 5:1.

14 . The method of claim 13 , wherein a diameter of the expandable structure in the unexpanded configuration is less than or equal to about 2 mm.

15 . The method of claim 13 , wherein the delivery system comprises an outer catheter having an inner diameter of less than or equal to about 2 mm.

16 . The method of claim 13 , wherein positioning the delivery system comprises advancing the delivery system over a guide wire.

17 . An endovascular occlusion device for occluding blood flow through a vessel, comprising:

an expandable frame; and

a membrane carried by the frame;

wherein the frame and the membrane are dimensioned for deployment from a tube having an inside diameter of no more than about 2 mm, and are expandable to a diameter of at least about 8 mm following deployment from the tube; and the membrane has a porosity which achieves a reduction in blood flow of at least about 80% within 5 minutes of deployment from the tube in a blood vessel.

18 . An endovascular occlusion device as in claim 17 , configured to achieve a reduction in blood flow of at least about 80% within 2 minutes of deployment from the tube in a blood vessel.

19 . An endovascular occlusion device as in claim 18 , configured to achieve a reduction in blood flow of at least about 80% within 1 minute of deployment from the tube in a blood vessel.

20 . An endovascular occlusion device as in claim 17 , configured to achieve total occlusion within 5 minutes of deployment from the tube in a blood vessel.

21 . An endovascular occlusion device as in claim 20 , configured to achieve total occlusion within 1 minute of deployment from the tube in a blood vessel.

22 . An endovascular occlusion device as in claim 17 , having an expansion ratio of at least about 6:1.

23 . An endovascular occlusion device as in claim 17 , having an expansion ratio of at least about 7:1.

24 . An endovascular occlusion device as in claim 17 , deliverable over an 0.018 inch guidewire.

25 . An endovascular occlusion device as in claim 17 , wherein the device has an average COP across a diameter of 2.5 mm to 8.0 mm of between about 30 mmHg and about 140 mmHg.

26 . An endovascular occlusion device for achieving mechanical occlusion of blood flow in a vessel, without requiring biological processes to achieve occlusion, comprising:

an expandable support structure, carrying a porous membrane, wherein the membrane is configured to obstruct blood flow through the vessel when the support structure is in an expanded configuration; the membrane having an average pore size of no more than about 100 microns.

27 . An endovascular occlusion device as in claim 26 , wherein the membrane comprises an average pore size of no more than about 50 microns.

28 . An endovascular occlusion device as in claim 26 , wherein the membrane comprises an average thickness of no more than about 30 microns.

29 . An endovascular occlusion device as in claim 26 , wherein the occlusion device is deliverable from a lumen having an inside diameter of no more than about 2 mm.

30 . An endovascular occlusion device as in claim 29 , wherein the occlusion device is deliverable from a lumen having an outside diameter of less than or equal to about 1.67 mm.

31 . An endovascular occlusion device as in claim 26 , deliverable over an 0.018 inch guidewire.

32 . An endovascular occlusion device as in claim 26 , wherein the device has an average COP across a diameter of 2.5 mm to 8.0 mm of between about 30 mmHg and about 140 mmHg.

33 . An endovascular occlusion device for occluding blood flow through a vessel, the occlusion device comprising a frame that is expandable through a range from a first, compressed diameter to a second, maximum expanded diameter, wherein the range of expansion is sufficient to occlude blood vessels having inside diameters anywhere within the range from about 2.5 mm to about 8 mm.

34 . An endovascular occlusion device as in claim 33 , wherein the range of expansion is sufficient to occlude blood vessels having inside diameters anywhere within the range from about 2.5 mm to about 8 mm.

35 . An endovascular occlusion device as in claim 33 , wherein the first, compressed diameter is small enough that the occlusion device is deployable from a lumen having an inside diameter of no more than about 2 mm.

36 . An endovascular occlusion device as in claim 35 , wherein the first, compressed diameter is small enough that the occlusion device is deployable from a lumen having an outside diameter of less than or equal to about 1.67 mm.

37 . An endovascular occlusion device as in claim 36 , having an expansion ratio of at least about 6:1.

38 . An endovascular occlusion device as in claim 37 , having an expansion ratio of at least about 7:1.

39 . An endovascular occlusion device as in claim 33 , deliverable over an 0.018 inch guidewire.

40 . An endovascular occlusion device as in claim 33 , wherein the device has an average COP across a diameter of 2.5 mm to 8.0 mm of between about 30 mmHg and about 140 mmHg.

41 . A low crossing profile, high dynamic range endovascular occlusion device having an opening for receiving a guidewire therethrough, the occlusion device expandable from a first diameter for transvascular navigation within a deployment catheter to a deployment site, to a second diameter for occluding a vessel following deployment from the catheter, wherein the catheter has a diameter of no greater than about 5 French and the expansion ratio is at least about 6×.

42 . A low crossing profile, high dynamic range endovascular occlusion device as in claim 41 , wherein the expansion ratio is at least about 8×.

43 . A low crossing profile, high dynamic range endovascular occlusion device as in claim 41 , comprising an expandable frame and an occlusion membrane.

44 . An endovascular occlusion deployment system for navigating tortuous vasculature to deploy an occlusion device at a target site in a vessel, comprising:

an elongate, flexible tubular body, having a proximal end, a distal end, and a diameter of no more than about 5 French; and

an occlusion device releasably carried in the distal end of the tubular body, the occlusion device having an expansion ratio of at least about 5 to 1;

wherein the distal end is advanceable to the trackability target vessel as determined by the test protocol identified in Trackability Protocol described herein.

45 . A low crossing profile, high dynamic range endovascular occlusion device with low elongation, the occlusion device expandable from a first diameter for transvascular navigation within a deployment catheter to a deployment site, to a second diameter for occluding a vessel following deployment from the catheter, wherein the catheter has a diameter of no greater than about 5 French, the occlusion device has an expansion ratio of at least about 5×, and the elongation of the device between the first diameter and the second diameter is no more than about 20%.

46 . A migration resistant endovascular occlusion device for occluding blood flow through a vessel, comprising:

an expandable frame comprising an upstream lobe and a downstream lobe separated by a neck portion; and

a membrane carried by the frame;

wherein the frame and membrane are dimensioned for deployment from a tube having an inside diameter of no more than about 2 mm, and are expandable to a diameter of at least about 8 mm following deployment from the tube; and

wherein the occlusion device exhibits a migration of less than about 5 mm in 10 minutes as determined by the test protocol identified in Migration Protocol described herein.

47 . An endovascular occlusion deployment system with contrast injection capability, for navigating tortuous vasculature to deploy an occlusion device at a target site in a vessel, comprising:

an elongate, flexible tubular body, having a proximal end, a distal end, and a diameter of no more than about 5 French; and

an occlusion device releasably carried in the distal end of the tubular body, the occlusion device having an expansion ratio of at least about 5 to 1; and

a contrast injection port on the body, proximal to the occlusion device;

wherein the contrast injection port permits injection of contrast while the occlusion device is in an expanded configuration and prior to release of the occlusion device from the tubular body.

48 . 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; and

a porous membrane carried by the upstream lobe.

49 . An endovascular occlusion device as in claim 48 , wherein the downstream lobe comprises a concave configuration, concave in a direction facing away from the upstream lobe.

50 . An endovascular occlusion device as in claim 49 , wherein the upstream lobe comprises a plurality of side wall struts.

51 . An endovascular occlusion device as in claim 50 , wherein the side wall struts carry the membrane.

52 . An endovascular occlusion device as in claim 48 , wherein the valve comprises a collapsible tube extending from the neck portion into the upstream lobe.

53 . An endovascular occlusion device as in claim 48 , wherein the downstream lobe comprises a plurality of side wall struts.

54 . An endovascular occlusion device as in claim 48 , 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.

55 . An endovascular occlusion device as in claim 54 , wherein blood pressure on the concave side of the upstream lobe generates an axially distal force on the neck portion.

56 . The endovascular occlusion device as in claim 48 , having an expansion ratio of at least about 6:1.

57 . The endovascular occlusion device as in claim 48 , having an expansion ratio of at least about 7:1.

58 . The endovascular occlusion device as in claim 48 , 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.

59 . The endovascular occlusion device as in claim 48 , wherein the device is configured to occlude at least about 90 percent of flow through a vessel when the expandable tubular frame is in an expanded configuration.

60 . An endovascular occlusion device as in claim 48 , configured to achieve a reduction in blood flow of at least about 80% within 2 minutes of deployment from the tube in a blood vessel.

61 . An endovascular occlusion device as in claim 60 , configured to achieve a reduction in blood flow of at least about 80% within 1 minute of deployment from the tube in a blood vessel.

62 . An endovascular occlusion device as in claim 61 , configured to achieve total occlusion within 5 minutes of deployment from the tube in a blood vessel.

63 . An endovascular occlusion device as in claim 62 , configured to achieve total occlusion within 1 minute of deployment from the tube in a blood vessel.

64 . An endovascular occlusion device deployment system, comprising the endovascular occlusion device of claim 51 , 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.

65 . A method of occluding a vessel, comprising the steps of:

deploying an anchoring lobe of an occlusion device in a vessel, without occluding blood flow;

thereafter deploying an occlusion lobe of the device in the vessel to occlude blood flow;

wherein the anchoring lobe is downstream of the occlusion lobe.

66 . A method of occluding a vessel as in claim 65 , additionally comprising evaluating the position of the occlusion device in the vessel prior to the deploying an occlusion lobe step.

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

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

the support structure defining a first axially outwardly facing concavity when in the enlarged configuration, the concavity having an upstream opening and a downstream end;

a guidewire opening in the downstream end; and

a collapsible tube extending from the guidewire opening in an upstream direction into the concavity.

68 . An endovascular occlusion device as in claim 67 , further comprising a membrane carried by the support structure.

69 . An endovascular occlusion device as in claim 68 , wherein the support structure additionally comprises a downstream lobe.

70 . An endovascular occlusion device as in claim 69 , wherein the downstream lobe comprises a plurality of struts spaced apart when in the enlarged configuration, to provide a plurality of openings therethrough.

71 . An endovascular occlusion device as in claim 70 , wherein the struts define a second concavity, facing in an opposite direction from the first, upstream facing concavity.

72 . A vascular occlusion device, comprising:

a frame comprising a proximal lobe and a distal lobe separated by a hub;

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

a hinge on the hub, to permit relative lateral deflection of the proximal and distal lobes to allow the frame to conform to a curved vessel; and

an embolic membrane carried by the proximal lobe.

73 . A vascular occlusion device as in claim 72 , wherein the hinge comprises at least one slot in a side wall of the hub.

74 . A vascular occlusion device as in claim 72 , wherein the hinge comprises a spiral slot in a side wall of the hub.

75 . A vascular occlusion device as in claim 72 , further comprising a guidewire lumen extending through the hub.

76 . A vascular occlusion device as in claim 75 , further comprising an occluder for occluding the guidewire lumen.

77 . A vascular occlusion device as in claim 76 , wherein the occluder comprises a membrane configured to occlude the guidewire lumen following removal of a guidewire.

78 . A vascular occlusion device as in claim 77 , wherein the occluder comprises a tubular membrane having a central lumen for removably receiving a guidewire.

79 . A vascular occlusion device as in claim 78 , wherein the tubular membrane is connected to the embolic membrane.

80 . A vascular occlusion device as in claim 78 , wherein the tubular membrane is integrally formed with the embolic membrane.

81 . A vascular occlusion device as in claim 78 , wherein the tubular membrane has a first end which is anchored with respect to the hub, and a free end spaced apart from the anchored end.

82 . A vascular occlusion device as in claim 81 , wherein the tubular membrane is invertible, such that the free end can be moved between the distal lobe and the proximal lobe.

83 . A vascular occlusion device as in claim 81 , wherein the distal lobe has a distal landing zone and a proximal tapered zone which tapers radially inwardly in the proximal direction to permit retraction of the distal lobe into a tubular sheath.

84 . A vascular occlusion device as in claim 72 , wherein the embolic membrane is concave in the proximal direction.

85 . A vascular occlusion device as in claim 84 , wherein the embolic membrane extends along an axis between a distal apex and a proximal opening, and the length of the membrane measured along the axis is no more than about 50% of the length of the device.

86 . A vascular occlusion device as in claim 85 , wherein the length of the membrane measured along the axis is no more than about 40% of the length of the device.

87 . A vascular 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.