Multiple Layer Filamentary Devices for Treatment of Vascular Defects

Abstract

Embolic implants, delivery systems and methods of manufacture and delivery are disclosed. The devices can be used for aneurysm treatment and/or parent vessel occlusion. Implant designs offer low profile compressibility for delivery to neurovasculature, while maintaining other necessary features such as density for occlusion purposes and desirable radial strength characteristics.

1 . An embolic device for treatment a patient's vasculature, comprising:
 resilient NiTi alloy braid forming an inner structure and an outer structure, the structures further comprising a plurality of wires in the braid, the wires secured relative to each other at either or both of proximal and distal ends thereof,   the device being adapted to compress into a compressed state for delivery through a catheter and self-expand and longitudinally shorten into an expanded state upon release from constraint,   wherein the braid is of a density configured to occlude blood flow at endovascular sites through thrombosis, and   the inner structure is disposed within the outer structure.   
     
     
         2 . The device of  claim 1 , wherein the inner and outer structures are contiguous with one another. 
     
     
         3 . The device of  claim 1 , wherein the wire ends are secured using a hub, band, or wrap. 
     
     
         4 . The device of  claim 1 , wherein the wire is between about 0.0008 inches and about 0.003 inches in diameter. 
     
     
         5 . The device of  claim 1 , wherein braid of the outer structure comprises at least about 48 wires. 
     
     
         6 . The device of  claim 1 , wherein the number of wires in the braid of the outer structure is selected from the group consisting of: 64, 72, 96, 128, or 144 wires. 
     
     
         7 . The device of  claim 1 , wherein braid of the inner structure comprises at least about 48 wires. 
     
     
         8 . The device of  claim 1 , wherein the number of wires in the braid of the inner structure is selected from the group consisting of: 64, 72, 96, 128, or 144 wires. 
     
     
         9 . The device of  claim 1 , wherein the ball shape has a diameter between about 4 to about 12 mm. 
     
     
         10 . The device of  claim 1 , wherein the wires in the braid are secured at both the proximal and distal ends thereof. 
     
     
         11 . The device of  claim 1 , wherein a proximal end of the inner structure is secured to a proximal end of the outer structure. 
     
     
         12 . The device of  claim 1 , wherein the plurality of wires are of two different diameters. 
     
     
         13 . The device of  claim 12 , wherein the different diameter wires are uniformly interlaced in the braid. 
     
     
         14 . The device of  claim 12 , having a generally spherical or heart shape in the expanded state. 
     
     
         15 . The device of  claim 1 , wherein, in the expanded state, a gap is present between the inner and outer structures adjacent a distal end of the device. 
     
     
         16 . The device of  claim 15 , wherein a radiopaque marker is present across the gap. 
     
     
         17 . A method of treating a patient, comprising:
 providing a device for treatment of a patient's vasculature;   advancing the device to a treatment site within a patient's vasculature in a constrained elongated state; and   deploying the device within a vascular defect at the treatment site within the patient's vasculature such that an outer structure and an inner structure of the device self-expand to respective expanded states with an internal gap between a distal end of the inner structure and an inner surface at a distal end of the outer structure.   
     
     
         18 . The method of  claim 17 , wherein the device comprises a plurality of wires having wire ends that are secured at either or both of proximal and distal ends of the device using a hub, band or wrap. 
     
     
         19 . The method of  claim 17 , wherein a plurality of wires in the device are of two different diameters. 
     
     
         20 . The method of  claim 17 , wherein the device comprises:
 an outer structure having a proximal end, a distal end, a longitudinal axis and further including a plurality of elongate, resilient, braid filaments secured relative to each other at proximal and distal ends thereof, wherein the outer structure has a radially constrained elongated state configured for delivery within a catheter, and an expanded relaxed state with a longitudinally shortened configuration relative to the radially constrained state, and   an inner structure of braid filaments disposed within an interior volume of the outer structure and secured relative to each other at least the proximal ends thereof, wherein the inner structure has a radially constrained elongated state which is shorter than the outer structure in its radially constrained state and which has an expanded relaxed state with a longitudinally shortened configuration relative to the radially constrained state.   
     
     
         21 . An embolic device for treatment of a patient's neurovasculature, comprising:
 an outer layer of braided resilient NiTi alloy wires;   an inner layer of braided resilient NiTi alloy wires, wherein the braid layers are adapted to compress to a compressed state for delivery through a catheter and self-expand to an expanded state upon release from constraint, the inner braid layer is disposed within the outer braid layer, is shorter than the outer layer and defines an enclosed volume, and the inner and outer braid layers meet at an end of the device; and   a hub at an opposite end of the device, said hub holding only the outer braid layer.   
     
     
         22 . The device of  claim 21 , wherein the braid is of a density configured to occluding blood flow at endovascular sites through thrombosis. 
     
     
         23 . The device of  claim 21 , wherein the wire is between about 0.0008 inches and about 0.003 inches in diameter. 
     
     
         24 . The device of  claim 21 , wherein braid of the outer layer comprises at least about 48 wires. 
     
     
         25 . The device of  claim 21 , wherein the number of wires in the braid of the outer layer is selected from the group consisting of: 64, 72, 96, 128, or 144 wires. 
     
     
         26 . The device of  claim 21 , wherein braid of the inner layer comprises at least about 48 wires. 
     
     
         27 . The device of  claim 21 , wherein the number of wires in the braid of the inner layer is selected from the group consisting of: 64, 72, 96, 128, or 144 wires. 
     
     
         28 . The device of  claim 21 , wherein the outer braid layer forms a shape having a diameter between about 4 mm and about 12 mm in the expanded state. 
     
     
         29 . The device of  claim 21  or  claim 22 , wherein the plurality of wires are of two different diameters. 
     
     
         30 . The device of  claim 23 , wherein the different diameter wires are uniformly interlaced in the braid. 
     
     
         31 . A method of treating a patient, comprising:
 providing a device for treatment of a patient's vasculature as described in  claim 21 ;   advancing the device to a treatment site within a patient's vasculature in a constrained elongated state; and   deploying the device within a vascular defect at the treatment site within the patient's vasculature such that an outer structure and an inner structures of the device self-expand to respective expanded states with unsecured ends of the inner structure independent of the outer braid layer hub.   
     
     
         32 . The method of  claim 31 , wherein the plurality of wires are of two different diameters. 
     
     
         33 . 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 secured relative to each other at proximal ends and distal ends thereof,   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; and   an inner structure of filamentary members disposed within the resilient permeable shell.   
     
     
         34 . The device of  claim 33  wherein filaments of the resilient permeable shell comprise a transverse dimension or diameter that is about 0.001 inches to about 0.004 inches. 
     
     
         35 . The device of  claim 33  wherein filaments of the inner structure comprise a transverse dimension or diameter that is less than about 0.001 inches. 
     
     
         36 . The device of  claim 33  wherein the resilient permeable shell comprises about 70 to about 300 filaments extending from the first end to the second end. 
     
     
         37 . The device of  claim 33  wherein the inner structure comprises about 70 to about 300 filaments extending from a first end to the second end. 
     
     
         38 . The device of  claim 33  wherein a major transverse dimension of the resilient permeable shell in a relaxed expanded state is about 4 mm to about 30 mm. 
     
     
         39 . The device of  claim 33  wherein the filaments of the inner structure comprise a woven structure forming an enclosed volume. 
     
     
         40 . The device of  claim 39  wherein the inner structure comprises:
 a radially constrained elongated state configured for delivery within a microcatheter with the thin woven filaments of the inner structure extending longitudinally from a proximal end to a 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 a 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. 
 
     
     
         41 . The device of  claim 39  wherein a proximal end of the inner structure is secured to a proximal end of the permeable shell. 
     
     
         42 . The device of  claim 33  wherein the filaments of the permeable shell comprise at least two different transverse dimensions. 
     
     
         43 . The device of  claim 33  wherein the filaments of the inner structure comprise at least two different transverse dimensions. 
     
     
         44 . 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 secured relative to each other at proximal ends and distal ends thereof,   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 a major transverse diameter, 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, and including a plurality of openings in the shell formed between the woven filaments; and   wherein the diameter of the permeable shell in an expanded state, number of all filaments and diameter of the small filaments are configured such that the average opening size of the permeable shell in an expanded state is less than about 0.016 inches with the average opening size defined by the expression (1.7/N T )(πD−N T /2×d W ) where D is a diameter of the permeable shell in the expanded state in inches, N T  is the total number of filaments in the permeable shell, and d W  is the diameter of the smallest filaments in inches; and   an inner structure of filamentary members disposed within the resilient permeable shell.   
     
     
         45 . The device of  claim 44  wherein the filaments of the inner structure comprise a woven structure forming an enclosed volume. 
     
     
         46 . The device of  claim 44  wherein the inner structure comprises:
 a radially constrained elongated state configured for delivery within a microcatheter with the thin woven filaments of the inner structure extending longitudinally from a proximal end to a 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 a 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. 
 
     
     
         47 . The device of  claim 45  wherein a proximal end of the inner structure is secured to a proximal end of the permeable shell. 
     
     
         48 . The device of  claim 44  wherein the filaments of the permeable shell comprise at least two different transverse dimensions. 
     
     
         49 . 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 secured relative to each other at proximal ends and distal ends thereof,   a radially constrained elongated state configured for delivery within a microcatheter with the 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 a major transverse diameter, 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, and including a plurality of openings in the shell formed between the woven filaments; and   wherein the diameter of the permeable shell in an expanded state, number and diameter of large filaments and number and diameter of small filaments are configured such that the permeable shell in a constrained state has an outer transverse diameter of less than about 0.04 inches defined by the expression 1.48((N l d l +N s d s   2 )) 1/2  where N l  is the number of largest filaments in the permeable shell, N s  is the number of smallest filaments in the permeable shell, d l  is the diameter of the largest filaments in inches, and d s  is the diameter of the smallest filaments in inches; and   an inner structure of filamentary members disposed within the resilient permeable shell.   
     
     
         50 . The device of  claim 49  wherein the filaments of the inner structure comprise a woven structure forming an enclosed volume. 
     
     
         51 . 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 secured relative to each other at proximal ends and distal ends thereof,   a radially constrained elongated state configured for delivery within a microcatheter with the 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 a major transverse diameter, 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, and including a plurality of openings in the shell formed between the woven filaments;   wherein the diameter of the permeable shell in an expanded state, number and diameter of large filaments and number and diameter of small filaments are configured such that the permeable shell in an expanded state has a radial stiffness of about 0.014 lbf to about 0.284 lbf defined by the expression (1.2×10 6  lbf/D 4 )(N/d 1   4 +N s d s   4 ) where D is a diameter of the permeable shell in the expanded state in inches, N l  is the number of large filaments in the permeable shell, N s  is the number of small filaments in the permeable shell, d l  is the diameter of the largest filaments in inches, and d s  is the diameter of the smallest filaments in inches; and   an inner structure of filamentary members disposed within the resilient permeable shell.   
     
     
         52 . The device of  claim 51  wherein the filaments of the inner structure comprise a woven structure forming an enclosed volume. 
     
     
         53 . The device of  claim 52  wherein the inner structure comprises:
 a radially constrained elongated state configured for delivery within a microcatheter with the thin woven filaments of the inner structure extending longitudinally from a proximal end to a 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 a 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. 
 
     
     
         54 . The device of  claim 52  wherein a proximal end of the inner structure is secured to a proximal end of the permeable shell. 
     
     
         55 . The device of  claim 51  wherein the filaments of the permeable shell comprise at least two different transverse dimensions. 
     
     
         56 . A device for treatment of a patient's vasculature, comprising:
 a self-expanding resilient permeable structure having a proximal end, a distal end, a longitudinal axis, a radially constrained elongated state configured for delivery within a microcatheter, and an expanded relaxed state with a globular and longitudinally shortened configuration relative to the radially constrained state and extending from the longitudinal axis between the proximal end and distal end; the permeable structure comprising:   a plurality of elongate resilient filaments secured relative to each other at either or both proximal and distal ends of the structure, the filaments forming:   a resilient self-expanding permeable shell having proximal and distal ends and defining a cavity; and   at least one inner structure disposable within the shell cavity, with the resilient filaments forming the at least one inner structure terminating at a hub disposed at the proximal end of the permeable structure.   
     
     
         57 . The device of  claim 56 , wherein the length of the inner structure in its radially constrained state is about 40% to about 90% the length of the permeable shell in its radially constrained state. 
     
     
         58 . The device of  claim 56 , wherein the shell generally has a truncated sphere or heart-like vertical cross-sectional shape. 
     
     
         59 . The device of  claim 56 , wherein at least about 80% of the volume of the at least one inner structure is contained within a proximal half of the shell. 
     
     
         60 . 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 secured relative to each other at proximal ends and distal ends thereof,   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; and   an inner structure of filamentary members disposed within an interior volume of the resilient permeable shell and comprising:   a plurality of elongate resilient filaments with a woven structure secured relative to each other at distal ends thereof and secured to each other and to the proximal ends of the filaments of the permeable shell at proximal ends thereof,   a radially constrained elongated state which is shorter than the permeable shell in its radially constrained state and which is 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.   
     
     
         61 . The device of  claim 60  wherein the largest of the openings in the permeable shell are configured to allow blood flow through the openings at a velocity below a thrombotic threshold velocity. 
     
     
         62 . The device of  claim 60  wherein the length of the inner structure in its radially constrained state is less than about 90% the length of the permeable shell in its radially constrained state. 
     
     
         63 . The device of  claim 62  wherein the length of the inner structure in its radially constrained state is about 40% to about 90% the length of the permeable shell in its radially constrained state. 
     
     
         64 . The device of  claim 60  wherein filaments of the resilient permeable shell comprise a transverse dimension or diameter that is about 0.001 inches to about 0.004 inches. 
     
     
         65 . The device of  claim 60  wherein filaments of the inner structure comprise a transverse dimension or diameter that is less than about 0.001 inches. 
     
     
         66 . The device of  claim 60  wherein filaments of the resilient permeable shell comprise a transverse dimension or diameter that is about 0.0004 inches to about 0.001 inches. 
     
     
         67 . The device of  claim 60  wherein the resilient permeable shell comprises about 70 to about 300 filaments extending from the first end to the second end. 
     
     
         68 . The device of  claim 60  wherein the inner structure comprises about 70 to about 300 filaments extending from a first end to the second end. 
     
     
         69 . The device of  claim 60  wherein a major transverse dimension of the resilient permeable shell in a relaxed expanded state is about 4 mm to about 30 mm. 
     
     
         70 . The device of  claim 60  wherein the filaments of the inner structure comprise a woven structure forming an enclosed volume. 
     
     
         71 . The device of  claim 60  wherein the filaments of the permeable shell comprise at least two different transverse dimensions. 
     
     
         72 . A method of treating a patient, comprising:
 providing 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 including a plurality of elongate resilient filaments with a woven structure secured relative to each other at proximal ends and distal ends thereof, a radially constrained elongated state configured for delivery within a microcatheter, and an expanded relaxed state with a globular and longitudinally shortened configuration relative to the radially constrained, and   an inner structure of filamentary members disposed within an interior volume of the resilient permeable shell which includes a plurality of elongate resilient filaments with a woven structure secured relative to each other at least the proximal ends thereof, which has a radially constrained elongated state which is shorter than the permeable shell in its radially constrained state and which has an expanded relaxed state with a globular and longitudinally shortened configuration relative to the radially constrained state;   advancing the device to a treatment site within a patient's vasculature in a constrained elongated state; and   deploying the device within a vascular defect at the treatment site within the patient's vasculature such that the permeable shell and inner structure self-expand to their respective expanded states with an internal gap between a distal end of the inner structure and an inner surface at a distal end of the permeable shell.   
     
     
         73 . The method of  claim 72  wherein the internal gap is about 5% to about 40% of a longitudinal height of the device in an expanded state. 
     
     
         74 . The method of  claim 72  wherein the inner structure filaments are secured at the distal end thereof. 
     
     
         75 . The method of  claim 72  wherein filaments of the inner structure comprise a woven structure forming a substantially enclosed volume. 
     
     
         76 . A method of treating a patient, comprising:
 providing 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 including a plurality of elongate resilient filaments with a woven structure secured relative to each other at proximal ends and distal ends thereof, a radially constrained elongated state configured for delivery within a microcatheter, and an expanded relaxed state with a globular and longitudinally shortened configuration relative to the radially constrained, and   an inner structure of filamentary members disposed within an interior volume of the resilient permeable shell and secured to the permeable shell at an end thereof, the inner structure including a plurality of elongate resilient filaments with a woven structure secured relative to each other at least the proximal ends thereof, which has a radially constrained elongated state which is shorter than the permeable shell in its radially constrained state and which has an expanded relaxed state with a longitudinally shortened configuration relative to the radially constrained state;   advancing the device to a treatment site within a patient's vasculature in a constrained elongated state; and   deploying the device within a vascular defect at the treatment site within the patient's vasculature such that the permeable shell and inner structure self-expand to their respective expanded states with a free unsecured end of the inner structure longitudinally shortening independently of the permeable shell structure.   
     
     
         77 . The method of  claim 76  wherein a longitudinal length of the inner structure of the device in a collapsed state is less than about 90% of the longitudinal length of the permeable shell in a collapsed state. 
     
     
         78 . The method of  claim 76  wherein the inner structure has a globular shape defining a substantially closed volume. 
     
     
         79 . The device of  claim 76  wherein the filaments of at least one of either the permeable shell or the inner structure comprise at least two different transverse dimensions.