METHOD AND APPARATUS FOR THE TREATMENT OF LARGE AND GIANT VASCULAR DEFECTS
Devices and methods for treatment of a patient's vasculature with some embodiments configured for delivery with a microcatheter for treatment of the cerebral vasculature of a patient. Some embodiments may include the deployment of multiple permeable shell devices within a single vascular defect.
1 . A method of treating a patient, comprising:
providing a plurality of devices for treatment of a patient's vasculature, each device comprising:
a self-expanding resilient layer including a proximal end, a distal end, a longitudinal axis and further including a plurality of elongate resilient filaments with a woven structure secured relative to each other along at least one of the proximal ends and distal ends thereof, and a radially constrained elongated state configured for delivery within a microcatheter, and an expanded relaxed state including a globular configuration;
advancing a first device for treatment of a patient's vasculature in a constrained elongated state to a vascular defect within the patient's vasculature, the vascular defect including an interior volume within a patient's vasculature;
deploying the first device for treatment of a patient's vasculature within the vascular defect within the patient's vasculature such that the resilient layer of the first device for treatment of a patient's vasculature self-expands to its expanded state within the interior volume of the vascular defect;
advancing at least one additional device for treatment of a patient's vasculature in a constrained elongated state to the vascular defect within the patient's vasculature; and
deploying the at least one additional device for treatment of a patient's vasculature within the vascular defect within the patient's vasculature such that the resilient layer of the at least one additional device for treatment of a patient's vasculature self-expands to its expanded state.
2 . The method of claim 1 wherein advancing at least one additional device for treatment of a patient's vasculature comprises advancing a device for treatment of a patient's vasculature having a size that is different from the size of the first device for treatment of a patient's vasculature.
3 . The method of claim 1 wherein advancing the first device for treatment of a patient's vasculature to a vascular defect comprises advancing the first device for treatment of a patient's vasculature to an aneurysm within the patient's vasculature.
4 . The method of claim 1 wherein advancing the first device for treatment of a patient's vasculature to a vascular defect comprises advancing a first device for treatment of a patient's vasculature to an aneurysm that is sized to block a neck of the aneurysm from within the interior volume of the aneurysm within the patient's vasculature.
5 . The method of claim 4 further comprising advancing a microcatheter past the first device for treatment of a patients vasculature and neck of the aneurysm and deploying the at least one additional device for treatment of a patient's vasculature within the interior volume of the aneurysm.
6 . The method of claim 1 wherein the step of deploying at least one additional device for treatment of a patient's vasculature is repeated until up to about 10 devices for treatment of a patient's vasculature have been deployed within the vascular defect.
7 . The method of claim 1 wherein advancing any of the devices for treatment of a patient's vasculature comprises advancing a resilient layer including a plurality of elongate resilient filaments with a woven structure forming at least one open end at either the proximal end or the distal end of the self-expanding resilient layer.
8 . The method of claim 1 wherein advancing any of the devices for treatment of a patient's vasculature comprises advancing a resilient layer including a plurality of elongate resilient filaments with a woven structure forming at least one open end at either the proximal end or the distal end of the self-expanding resilient layer with the open end being bounded by a folded portion of the elongate filaments.
9 . The method of claim 1 wherein advancing any of the devices for treatment of a patient's vasculature comprises advancing a resilient layer including a plurality of elongate resilient filaments with a woven structure forming at least one open end at either the proximal end or the distal end of the self-expanding resilient layer with the open end being bounded by filament ends which are heat formed to one or more adjacent filament ends.
10 . A device for treatment of a patient's vasculature, comprising:
a self-expanding resilient permeable shell having a proximal end, a distal end, a longitudinal axis and further comprising:
a plurality of elongate resilient filaments with a woven structure and forming at least one open end at either the proximal end or the distal end of the self-expanding resilient permeable shell, wherein the open end is formed by one or more filament ends having a folded configuration,
a radially constrained elongated state configured for delivery within a microcatheter with the thin woven filaments extending longitudinally from the proximal end to the distal end radially adjacent each other along a length of the filaments, and
an expanded relaxed state with a globular and longitudinally shortened configuration relative to the radially constrained state with the woven filaments forming the self-expanding resilient permeable shell in a smooth path radially expanded from the longitudinal axis between the proximal end and distal end including a plurality of openings in the shell formed between the woven filaments, the largest of said openings being configured to allow blood flow through the openings at a velocity below a thrombotic threshold velocity.
11 . The device of claim 10 wherein filaments of the resilient permeable shell comprise a transverse dimension or diameter that is about 0.0007 inches to about 0.004 inches.
12 . The device of claim 10 wherein the resilient permeable shell comprises about 70 to about 360 filaments extending from the first end to the second end.
13 . The device of claim 10 wherein a major transverse dimension of the resilient permeable shell in a relaxed expanded state is about 4 mm to about 30 mm.
14 . The device of claim 10 wherein the radial stiffness of the filaments is about 0.02 lbf to about 0.23 lbf.
15 . The device of claim 10 wherein the plurality of openings formed between the woven filaments measure about 0.075 mm to about 0.30 mm in diameter.
16 . The device of claim 10 wherein the device further comprises an inner structure of filamentary members disposed within an interior volume of the resilient permeable shell.
17 . A device for treatment of a patient's vasculature, comprising:
a self-expanding resilient permeable shell having a proximal end, a distal end, a longitudinal axis and further comprising:
a plurality of elongate resilient filaments with a woven structure and forming at least one open end at either the proximal end or the distal end of the self-expanding resilient permeable shell, wherein the open end is formed by one or more filament ends heat-formed to one or more additional filament ends,
a radially constrained elongated state configured for delivery within a microcatheter with the thin woven filaments extending longitudinally from the proximal end to the distal end radially adjacent each other along a length of the filaments, and
an expanded relaxed state with a globular and longitudinally shortened configuration relative to the radially constrained state with the woven filaments forming the self-expanding resilient permeable shell in a smooth path radially expanded from the longitudinal axis between the proximal end and distal end including a plurality of openings in the shell formed between the woven filaments, the largest of said openings being configured to allow blood flow through the openings at a velocity below a thrombotic threshold velocity.
18 . The device of claim 17 wherein filaments of the resilient permeable shell comprise a transverse dimension or diameter that is about 0.0007 inches to about 0.004 inches.
19 . The device of claim 17 wherein the resilient permeable shell comprises about 70 to about 360 filaments extending from the first end to the second end.
20 . The device of claim 17 wherein a major transverse dimension of the resilient permeable shell in a relaxed expanded state is about 4 mm to about 30 mm.
21 . The device of claim 17 wherein the radial stiffness of the filaments is about 0.02 lbf to about 0.23 lbf.
22 . The device of claim 17 wherein the plurality of openings formed between the woven filaments measure about 0.075 mm to about 0.30 mm in diameter.
23 . The device of claim 17 wherein the device further comprises an inner structure of filamentary members disposed within an interior volume of the resilient permeable shell.
24 . A method of treating a vascular site of a patient, the vascular site including an interior volume and a neck or ostium, comprising:
advancing a first tubular catheter to the vascular site;
advancing a second tubular catheter to a position adjacent the neck or ostium of the vascular site;
advancing a first device in a constrained elongated state through an inner lumen of the first tubular catheter to the vascular site;
deploying the first device at the vascular site adjacent the neck or ostium of the vascular site such that the first device self-expands to its relaxed expanded state;
advancing a second device for treatment of a patient's vasculature through an inner lumen the second catheter to the vascular site, the second device for treatment of a patient's vasculature comprising a self-expanding resilient permeable shell including a proximal end, a distal end, a longitudinal axis and further including a plurality of elongate resilient filaments with a woven structure secured relative to each other along at least one of the proximal ends and distal ends thereof, a radially constrained elongated state configured for delivery within a microcatheter, and an expanded relaxed state; and
deploying the second device for treatment of a patient's vasculature inside the vascular site such that the second device for treatment of a patient's vasculature self-expands to its relaxed expanded state.
25 . The method of claim 24 wherein the first device is deployed in a manner configured to retain the second device for treatment of a patient's vasculature within the interior volume of the vascular site.
26 . The method of claim 24 wherein the first device is deployed after placement of the second catheter but before the deployment of the second device for treatment of a patient's vasculature such that the second device is deployed using a jailing technique.
27 . The method of claim 24 wherein advancing a first device in a constrained elongated state through an inner lumen of the first tubular catheter to the vascular site comprises advancing a stent, coil, flow diverter, or resilient permeable shell.