Embolisation systems

Abstract

A bristle device 8 for delivery into a body lumen comprises a longitudinally extending stem 1 and a plurality of bristles extending generally outwardly from the stem for anchoring the device in a body lumen. There may be at least two bristle segments 96 and there are flexible sections 95 between the segments 96. The flexible sections 95 articulate to enable the device to pass through a catheter placed in a tortuous anatomy or to be deployed in a curved vessel, or across a bifurcation. In some cases at least some of the bristle segments 96 are spaced-apart to accommodate bending of the bristles.

What is claimed is: 
     
         1 . An embolisation bristle device for promoting clot formation in a body lumen comprising a stem and a plurality of flexible bristles extending generally radially outwardly from the stem, the bristles having a contracted delivery configuration and a deployed configuration in which the bristles extend generally radially outwardly of the stem to anchor the device in a lumen, the device comprising one or more segments, each of which comprises a group of the plurality of bristles, further comprising a flow restrictor having a contracted delivery configuration and an expanded deployed configuration, wherein the flow restrictor comprises a membrane, and wherein at least some of the bristles are configured to urge the flow restrictor into the deployed configuration from the delivery configuration, and at least a portion of the membrane is located between bristles of the group on both sides of the restrictor. 
     
     
         2 . The embolisation bristle device of  claim 1 , wherein the flow restrictor is located at a proximal end of the device and/or at a distal end of the device. 
     
     
         3 . The embolisation bristle device of  claim 1 , wherein the bristle device is configured to be attached to a delivery wire via a screw mechanism. 
     
     
         4 . The embolisation bristle device of  claim 1 , wherein the membrane is made of PTFE, Nylon, PET, PEEK, Polyurethane, Polypropylene, Silicon or a Dacron mesh. 
     
     
         5 . The embolisation bristle device of  claim 1 , wherein the membrane is comprised of a film, weave, braid or fabric construction. 
     
     
         6 . The embolisation bristle device of  claim 1 , wherein at least one of the one or more segments has a segment bristle density from 100 to 1000 per centimetre of segment length. 
     
     
         7 . The embolisation bristle device of  claim 1 , wherein at least one of the one or more segments has a segment diameter from 3 to 24 mm. 
     
     
         8 . The embolisation bristle device of  claim 1 , wherein at least one of the one or more segments has a segment length of less than 8 mm. 
     
     
         9 . The embolisation bristle device of  claim 1 , wherein the stem is formed by a twisted wire. 
     
     
         10 . The embolisation bristle device of  claim 9 , wherein the twisted wire is made from stainless steel and has a diameter of 0.508 mm or less. 
     
     
         11 . The embolisation bristle device of  claim 1 , further comprising a plurality of bristle segments and flexible sections between at least some of the bristle segments such that bending within the embolisation bristle device is taken up primarily by the flexible sections. 
     
     
         12 . An embolisation bristle device loading system comprising:
 an embolisation device comprising a stem and a plurality of flexible bristles extending generally radially outwardly from the stem, the bristles having a contracted delivery configuration and a deployed configuration in which the bristles extend generally radially outwardly of the stem to anchor the device in a lumen, the device comprising one or more segments, each of which comprises a group of the plurality of bristles, further comprising a flow restrictor having a contracted delivery configuration and an expanded deployed configuration, wherein the flow restrictor comprises a membrane, and wherein at least some of the bristles are configured to urge the flow restrictor into the deployed configuration from the delivery configuration, and at least a portion of the membrane is located between bristles of the group on both sides of the restrictor;   a loading tube; and   a loading element for loading the embolisation device into the loading tube.   
     
     
         13 . The embolisation bristle device loading system of  claim 12 , further comprising a taper or a funnel to aid loading of the bristle device into the loading tube and/or a delivery catheter, and, wherein the taper or funnel comprises an extension of the loading tube. 
     
     
         14 . The embolisation bristle device loading system of  claim 12 , wherein the loading tube comprises a re-orientation means for re-orientating at least some of the bristles of the bristle device as the bristle device is passing through the loading tube. 
     
     
         15 . The embolisation bristle device loading system of  claim 14 , wherein the re-orientation means comprises at least one hole in the wall of the loading tube through which the bristles may temporarily extend radially outwardly for transition from a first configuration in which the bristles are aligned at a first angle to the longitudinal axis of the loading tube and a second configuration in which the bristles are aligned at a second angle to the longitudinal axis of the loading tube. 
     
     
         16 . A method for loading an embolisation bristle device into a delivery catheter comprising the steps of:
 providing the embolisation device according, a loading tube and a loading element, wherein the embolisation device comprises a stem and a plurality of flexible bristles extending generally radially outwardly from the stem, the bristles having a contracted delivery configuration and a deployed configuration in which the bristles extend generally radially outwardly of the stem to anchor the device in a lumen, the device comprising one or more segments, each of which comprises a group of the plurality of bristles, further comprising a flow restrictor having a contracted delivery configuration and an expanded deployed configuration, wherein the flow restrictor comprises a membrane, and wherein at least some of the bristles are configured to urge the flow restrictor into the deployed configuration from the delivery configuration, and at least a portion of the membrane is located between bristles of the group on both sides of the restrictor;   using the loading element, delivering the embolisation device into the loading tube; and   using the loading element, delivering the embolisation device into a delivery catheter.   
     
     
         17 . The method of  claim 16 , wherein the flow restrictor is located at a proximal end of the device and/or at a distal end of the device. 
     
     
         18 . The method of  claim 16 , wherein the bristle device is configured to be attached to a delivery wire via a screw mechanism. 
     
     
         19 . The method of  claim 16 , wherein the membrane is made of PTFE, Nylon, PET, PEEK, Polyurethane, Polypropylene, Silicon or a Dacron mesh. 
     
     
         20 . The method of  claim 16 , wherein the membrane is comprised of a film, weave, braid or fabric construction.