Multiple layer filamentary devices or treatment of vascular defects

Abstract

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 a permeable shell and inner structure configured to occlude blood flow therethrough.

1 . 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.   
     
     
         2 . The device of  claim 1  wherein filaments of the resilient permeable shell comprise a transverse dimension or diameter that is about 0.001 inches to about 0.004 inches. 
     
     
         3 . The device of  claim 1  wherein filaments of the inner structure comprise a transverse dimension or diameter that is less than about 0.001 inches. 
     
     
         4 . The device of  claim 1  wherein the resilient permeable shell comprises about 70 to about 300 filaments extending from the first end to the second end. 
     
     
         5 . The device of  claim 1  wherein the inner structure comprises about 70 to about 300 filaments extending from a first end to the second end. 
     
     
         6 . The device of  claim 1  wherein a major transverse dimension of the resilient permeable shell in a relaxed expanded state is about 4 mm to about 30 mm. 
     
     
         7 . The device of  claim 1  wherein the filaments of the inner structure comprise a woven structure forming an enclosed volume. 
     
     
         8 . The device of  claim 7  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. 
 
     
     
         9 . The device of  claim 7  wherein a proximal end of the inner structure is secured to a proximal end of the permeable shell. 
     
     
         10 . The device of  claim 1  wherein the filaments of the permeable shell comprise at least two different transverse dimensions. 
     
     
         11 . The device of  claim 1  wherein the filaments of the inner structure comprise at least two different transverse dimensions. 
     
     
         12 . 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.   
     
     
         13 . The device of  claim 12  wherein the filaments of the inner structure comprise a woven structure forming an enclosed volume. 
     
     
         14 . The device of  claim 12  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. 
 
     
     
         15 . The device of  claim 13  wherein a proximal end of the inner structure is secured to a proximal end of the permeable shell. 
     
     
         16 . The device of  claim 12  wherein the filaments of the permeable shell comprise at least two different transverse dimensions. 
     
     
         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 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.   
     
     
         18 . The device of  claim 17  wherein the filaments of the inner structure comprise a woven structure forming an enclosed volume. 
     
     
         19 . 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 l d l   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.   
     
     
         20 . The device of  claim 19  wherein the filaments of the inner structure comprise a woven structure forming an enclosed volume. 
     
     
         21 . The device of  claim 20  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. 
 
     
     
         22 . The device of  claim 20  wherein a proximal end of the inner structure is secured to a proximal end of the permeable shell. 
     
     
         23 . The device of  claim 19  wherein the filaments of the permeable shell comprise at least two different transverse dimensions. 
     
     
         24 . 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.   
     
     
         25 . The device of  claim 24 , 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. 
     
     
         26 . The device of  claim 24 , wherein the shell generally has a truncated sphere or heart-like vertical cross-sectional shape. 
     
     
         27 . The device of  claim 24 , wherein at least about 80% of the volume of the at least one inner structure is contained within a proximal half of the shell. 
     
     
         28 . 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. 
   
     
     
         29 . The device of  claim 28  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. 
     
     
         30 . The device of  claim 28  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. 
     
     
         31 . The device of  claim 30  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. 
     
     
         32 . The device of  claim 28  wherein filaments of the resilient permeable shell comprise a transverse dimension or diameter that is about 0.001 inches to about 0.004 inches. 
     
     
         33 . The device of  claim 28  wherein filaments of the inner structure comprise a transverse dimension or diameter that is less than about 0.001 inches. 
     
     
         34 . The device of  claim 28  wherein filaments of the resilient permeable shell comprise a transverse dimension or diameter that is about 0.0004 inches to about 0.001 inches. 
     
     
         35 . The device of  claim 28  wherein the resilient permeable shell comprises about 70 to about 300 filaments extending from the first end to the second end. 
     
     
         36 . The device of  claim 28  wherein the inner structure comprises about 70 to about 300 filaments extending from a first end to the second end. 
     
     
         37 . The device of  claim 28  wherein a major transverse dimension of the resilient permeable shell in a relaxed expanded state is about 4 mm to about 30 mm. 
     
     
         38 . The device of  claim 28  wherein the filaments of the inner structure comprise a woven structure forming an enclosed volume. 
     
     
         39 . The device of  claim 28  wherein the filaments of the permeable shell comprise at least two different transverse dimensions. 
     
     
         40 . 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.   
     
     
         41 . The method of  claim 40  wherein the internal gap is about 5% to about 40% of a longitudinal height of the device in an expanded state. 
     
     
         42 . The method of  claim 40  wherein the inner structure filaments are secured at the distal end thereof. 
     
     
         43 . The method of  claim 40  wherein filaments of the inner structure comprise a woven structure forming a substantially enclosed volume. 
     
     
         44 . 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.   
     
     
         45 . The method of  claim 44  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. 
     
     
         46 . The method of  claim 44  wherein the inner structure has a globular shape defining a substantially closed volume. 
     
     
         47 . The device of  claim 44  wherein the filaments of at least one of either the permeable shell or the inner structure comprise at least two different transverse dimensions.