Embolization device and a method of using the same

Abstract

A method of filling an aneurysm space within the abdominal aorta is disclosed. The method involves placing a prosthesis in the abdominal aorta; delivering a fillable bladder in a deflated state into the aneurysm space using a catheter; placing a filler tube in fluid communication with an inflow port of the fillable bladder. The fillable bladder comprises a bladder seal surrounding the fillable bladder and the bladder seal has a first side, a second side, a third side, and a fourth side. The first side is symmetric with the second side with respect to a first axis of the fillable bladder and the third side is symmetric with the fourth side with respect to a second axis of the fillable bladder. The first axis is perpendicular to the second axis. The method further involves filling the fillable bladder with a filling agent and removing the filler tube.

We claim: 
     
         1 . A device for filling an abnormal void within a body, comprising:
 a fillable body having a fillable space defined by an inner surface of the fillable body;   a first tube comprising a filler tube, wherein at least a portion of the inner surface of the fillable body surrounds at least a portion of the first tube; and   a second tube,   wherein the fillable body is deliverable over a guidewire to the abnormal void,   wherein at least a portion of the fillable body is positionable in the abnormal void,   wherein the fillable space is fillable with a hardenable or solidifiable filling agent,   wherein the fillable body has a filled configuration and an unfilled configuration,   wherein the fillable space has a larger volume in the filled configuration than in the unfilled configuration,   wherein the fillable body has a body wall and the first tube has a first tube wall, wherein at least a first portion of the body wall is expandable at least outward relative to the first tube wall in a first direction, wherein the at least a first portion of the body wall has a first portion first segment and a first portion second segment, wherein when the fillable body is in the filled configuration the first portion first segment is a first distance from the first tube wall and the first portion second segment is a second distance from the first tube wall, wherein the second distance is greater than the first distance, wherein when the fillable body is in the unfilled configuration the first portion first segment is closer to the first tube wall than the first distance and the first portion second segment is closer to the first tube wall than the second distance, wherein the at least a first portion defines at least a portion of the inner surface of the fillable body and surrounds at least a portion of the first tube wall, and wherein the at least a first portion of the body wall is expandable away from the second tube,   wherein at least a portion of the first tube is parallel to a fillable body central axis when the fillable body is in the unfilled configuration, and   wherein the fillable body is sized to fit the abnormal void when in the filled configuration.   
     
     
         2 . The device of  claim 1 , wherein at least a second portion of the body wall is expandable at least outward relative to the fillable body central axis in a second direction different from the first direction, wherein the at least a second portion of the body has a second portion first segment and a second portion second segment, wherein when the fillable body is in the filled configuration the second portion first segment is a third distance from the fillable body central axis and the second portion second segment is a fourth distance from the fillable body central axis, wherein the fourth distance is less than the third distance, wherein when the fillable body is in the unfilled configuration the second portion first segment is closer to the fillable body central axis than the third distance and the second portion second segment is closer to the fillable body central axis than the fourth distance, and wherein the at least a second portion defines at least a portion of the inner surface of the fillable body and surrounds at least a portion of the fillable body central axis. 
     
     
         3 . The device of  claim 2 , wherein the first direction is opposite the second direction. 
     
     
         4 . The device of  claim 2 , wherein the third and fourth distances are each less than or greater than each of the first and second distances. 
     
     
         5 . The device of  claim 2 , wherein the fillable body is configured to expand when the filling agent is delivered to the fillable space. 
     
     
         6 . The device of  claim 2 , wherein the fillable body has a port in fluid communication with a filling agent source and the fillable space when the filling agent is delivered to the fillable body. 
     
     
         7 . The device of  claim 6 , wherein the filler tube is connectable to the port. 
     
     
         8 . The device of  claim 7 , wherein the filling agent comprises at least one of a therapeutic agent, diagnostic agent, radiopaque agent and a binding agent. 
     
     
         9 . The device of  claim 8 , wherein the filled configuration is shaped for a specific abnormal void to minimize the risk that the fillable body would pass into a bloodstream and become an embolus after it is filled with the filling agent when in the abnormal void. 
     
     
         10 . The device of  claim 9 , wherein the fillable body has a seal at a longitudinal end of the fillable body. 
     
     
         11 . A device for filling an abnormal void within a body, comprising:
 a fillable body having a fillable space defined by an inner surface of the fillable body;   a first tube comprising a filler tube, wherein at least a portion of the inner surface of the fillable body surrounds at least a portion of the first tube; and   a second tube,   wherein the fillable body is deliverable over a guidewire to the abnormal void,   wherein at least a portion of the fillable body is positionable in the abnormal void,   wherein the fillable space is fillable with a hardenable or solidifiable filling agent,   wherein the fillable body has a filled configuration and an unfilled configuration,   wherein the fillable space has a larger volume in the filled configuration than in the unfilled configuration,   wherein the fillable body comprises a body wall having a body wall first section,   wherein the body wall first section is expandable at least outward relative to a fillable body central axis in a first direction, wherein when the fillable body is in the filled configuration the body wall first section is a first distance from the fillable body central axis, wherein when the fillable body is in the unfilled configuration the body wall first section is closer to the fillable body central axis than the first distance, and wherein the at least a first portion of the body wall is expandable away from the second tube,   wherein at least a portion of the first tube is parallel to a fillable body axis that extends from a first longitudinal end of the fillable body to a second longitudinal end of the fillable body when the fillable body is in the unfilled configuration, and   wherein the fillable body is sized to fit the abnormal void when in the filled configuration.   
     
     
         12 . The device of  claim 11 , wherein the body wall further comprises a body wall second section, wherein the body wall second section is expandable at least outward in a second direction relative to a first tube central axis, wherein the second direction is different from the first direction, wherein when the fillable body is in the filled configuration the body wall second section is a second distance from the first tube central axis, and wherein when the fillable body is in the unfilled configuration the body wall second section is closer to the first tube central axis and the first tube central axis than the second distance. 
     
     
         13 . The device of  claim 12 , wherein the fillable body is configured to expand when the filling agent is delivered to the fillable space. 
     
     
         14 . The device of  claim 12 , wherein the fillable body has a port in fluid communication with a filling agent source and the fillable space when the filling agent is delivered to the fillable body. 
     
     
         15 . The device of  claim 14 , wherein the filler tube is connectable to the port. 
     
     
         16 . The device of  claim 15 , wherein the filling agent comprises at least one of a therapeutic agent, diagnostic agent, radiopaque agent and a binding agent. 
     
     
         17 . The device of  claim 16 , wherein the filled configuration is shaped for a specific abnormal void to minimize the risk that the fillable body would pass into a bloodstream and become an embolus after it is filled with the filling agent when in the abnormal void. 
     
     
         18 . The device of  claim 17 , wherein the fillable body has a seal at a longitudinal end of the fillable body. 
     
     
         19 . A device for filling an abnormal void within a body, comprising:
 a fillable body having a fillable space defined by an inner surface of the fillable body;   a filler tube, wherein at least a portion of the inner surface of the fillable body surrounds at least a portion of the filler tube; and   a tube structure having a tube structure outer surface;   wherein the fillable body is deliverable over a guidewire to the abnormal void,   wherein at least a portion of the fillable body is positionable in the abnormal void,   wherein the fillable space is fillable with a hardenable solidifiable filling agent,   wherein the fillable body has a filled configuration and an unfilled configuration,   wherein the fillable space has a larger volume in the filled configuration than in the unfilled configuration,   wherein at least a first portion of the fillable body is expandable at least outward relative to a filler tube central axis in a first direction, wherein when the fillable body is in the filled configuration the first portion is a first distance from the filler tube central axis, wherein when the fillable body is in the unfilled configuration the first portion is closer to the filler tube central axis than the first distance, and wherein when the fillable body is in the filled configuration the first portion of the fillable body contacts at least a portion of the tube structure outer surface,   wherein at least a second portion of the fillable body is expandable at least outward relative to the filler tube central axis in a second direction different from the first direction, wherein when the fillable body is in the filled configuration the second portion is a second distance from the filler tube central axis, wherein when the fillable body is in the unfilled configuration the second portion is closer to the filler tube central axis than the second distance, and   wherein the fillable body is sized to fit the abnormal void when in the filled configuration.   
     
     
         20 . The device of  claim 19 , wherein the first and second directions are opposite to one another, wherein the fillable body is configured to expand when the filling agent is delivered to the fillable space, wherein the fillable body has a port in fluid communication with a filling agent source and the fillable space when the filling agent is delivered to the fillable body, wherein the filler tube is connectable to the port, wherein the filling agent comprises at least one of a therapeutic agent, diagnostic agent, radiopaque agent and a binding agent, and wherein the filled configuration is shaped for a specific abnormal void to minimize the risk that the fillable body would pass into a bloodstream and become an embolus after it is filled with the filling agent when in the abnormal void.