Patent Description:
Embolisation devices may be deployed in the vasculature at a particular location by a medical practitioner so as to promote blood clot formation and ultimately occlude the blood vessel. Typically, an embolisation device is pushed through a guide (delivery) catheter in a distal direction using a delivery wire until a point of deployment within a bodily lumen is reached. Once the device reaches the required point of deployment, the device is deployed from the guide catheter.

In some cases, the embolisation device may need to be recaptured after deployment from the delivery catheter, for example if the final position of the embolisation device within the bodily lumen is incorrect and needs to be re-adjusted.

In cases where the embolisation device must be recaptured, the delivery catheter must be moved back over the embolisation device.

The embolisation device may comprise a group of flexible bristles that extend radially outwardly and longitudinally in a direction opposite to the delivery direction of the embolisation device (i.e. a proximal direction). As the delivery catheter is moved over the embolisation device in the distal direction, the movement of the delivery catheter along the bristles can cause some or all of the flexible bristles in this group move longitudinally in the distal direction. Recapture of the embolisation device can therefore cause the proximally-orientated bristles to extend instead in the distal direction, leading to misalignment of the bristles. Such a misalignment can reduce the effectiveness of the embolisation device, such as increasing the time to occlusion of a blood vessel.

In view of the above, there is a need for an improved embolisation device which is able to be recaptured without causing damage to the proximally-oriented bristles, or without reorienting them.

<CIT> discloses an embolisation device for promoting clot formation in a bodily lumen and having a collapsed delivery configuration for delivery of the embolisation device into, and retrieval of the embolisation device from, the bodily lumen and an expanded deployed configuration for anchoring the embolisation device in the bodily lumen. The embolisation device comprises a tubular cage having a collapsed delivery configuration and an expanded deployed configuration. The embolisation device further comprises an embolisation member disposed in the tubular cage, the embolisation member comprising a stem and a plurality of flexible bristles extending outwardly from the stem, the plurality of flexible bristles having a collapsed delivery configuration and an expanded deployed configuration. The embolisation device is configured such that as the tubular cage is transitioned from its expanded deployed configuration to its collapsed delivery configuration the plurality of flexible bristles is urged by the tubular cage from the expanded deployed configuration of the flexible bristles to the collapsed delivery configuration of the flexible bristles.

<CIT> discloses a device for delivery into a body lumen having a longitudinally extending stem and a plurality of bristles extending generally radially outwardly from the stem. The device includes at least two different groups or types of bristles.

According to a first aspect, there is provided an apparatus comprising an embolisation device for promoting clot formation in a bodily lumen, the embolisation device comprising a core and a plurality of flexible bristles extending outwardly from the core, the bristles having a collapsed delivery configuration and an expanded deployed configuration in which the bristles extend at least radially outwardly from the core to contact the lumen and to anchor the device in the lumen, and a delivery catheter, wherein: the embolisation device is configured to be delivered in a distal direction from the delivery catheter to the lumen; in the expanded deployed configuration, a set of the flexible bristles extend radially outwardly from the core and longitudinally in a proximal direction opposite to the distal direction; and the apparatus further comprises a recapture mechanism, actuatable independently of the movement of the delivery catheter over the bristles, for moving the set of flexible bristles to a lower radial profile than in the expanded deployed configuration before the delivery catheter is moved over the set of flexible bristles.

According to a second aspect, there is provided an embolisation system comprising the embolisation device of the first aspect; and a delivery element for delivering the embolisation device to a bodily lumen through the delivery catheter; wherein the recapture mechanism is actuatable to decrease the radial profile the set of flexible bristles to a radial profile smaller than an inner radius of the distal tip of the delivery catheter.

According to a third aspect, there is provided a method of manufacturing an apparatus comprising an embolisation device for promoting clot formation in a bodily lumen, the embolisation device comprising a core and a plurality of flexible bristles extending outwardly from the core, the bristles having a collapsed delivery configuration and an expanded deployed configuration in which the bristles extend at least radially outwardly from the core to contact the lumen and to anchor the device in the lumen, the method comprising: providing a delivery catheter; providing a core; providing a set of flexible bristles configured to extend radially outwardly from the core and longitudinally in a proximal direction opposite to a direction in which the embolisation device is configured to be delivered from a delivery catheter; and providing a recapture mechanism, actuatable independently of the movement of the delivery catheter over the bristles, for moving the set of bristles to a lower radial profile than an expanded deployed configuration of the set of bristles before the delivery catheter is moved over the set of flexible bristles.

To enable better understanding of the present disclosure, and to show how the same may be carried into effect, reference will now be made, by way of example only, to the accompanying drawings, in which:.

Throughout this disclosure the term 'embolisation device' may refer to a device which may be permanently or semi-permanently implanted in a bodily lumen. Accordingly, the 'embolisation device' may be configured to be disposed within the bodily lumen for a period of time, such as a number of days, or disposed in the lumen indefinitely. To this end, the 'embolisation device' may be configured to be selectively detached from a delivery element so that it may be implanted in the bodily lumen in isolation.

Throughout this disclosure the term 'bodily lumen' may refer to the inside space within a tubular structure of the human or animal body. The 'bodily lumen' may be, for example, an artery or vein.

Throughout this disclosure the term 'contracted delivery configuration' of an element may refer to a configuration of the element which has a smaller radial extent than an expanded deployed configuration of the element.

Throughout this disclosure the term 'to anchor' may refer to partly or fully securing an element in a position.

Throughout this disclosure, the term 'core' may refer to an element which acts as a backbone for the device. The term 'stem' may refer to an elongate element which extends longitudinally along the length of the embolisation device to act as a backbone for the device, and has a significantly smaller radial extent than the further elements of the embolisation device (for example, the plurality of flexible bristles). The stem may extend along substantially the whole longitudinal extent of the plurality of flexible bristles (e.g. when the embolisation device is in an unrestrained configuration, contracted delivery configuration and/or expanded deployed configuration). The stem may extend along substantially the whole length of the embolisation device.

In any of the examples described herein, the term 'bristle' may refer to an elongate strand of material formed substantially a single piece. The 'bristle' may be a resilient bristle. The resilient bristle may be biased towards a particular curvature.

Throughout this disclosure, the term 'radially outwardly' does not exclude the element additionally extending in the longitudinal direction of the device. For example, the plurality of flexible bristles may extend radially outwardly and longitudinally from the stem.

Through this disclosure, the term 'radial profile' may refer to a radial extent in a particular direction radially outwardly from the stem of the embolisation device. For example, the embolisation device has a lower radial extent in the contracted delivery configuration than in the expanded deployed configuration.

The plurality of flexible bristles may have a contracted configuration in the contracted delivery configuration. The plurality of flexible bristles may have an expanded configuration in the expanded deployed configuration. The plurality of bristles may extend radially outwardly from the stem in a plurality of circumferential directions about the stem.

In the expanded configuration, the plurality of flexible bristles may be configured to anchor the device in the bodily lumen. The plurality of flexible bristles may be configured to provide substantially all of the anchoring force for the embolisation device in the bodily lumen.

In the expanded configuration, the plurality of flexible bristles may be configured to contact the bodily lumen.

In the contracted delivery configuration, the plurality of flexible bristles extending outwardly from the stem are contracted such that radial extent of the device is less than the radial extent of the expanded deployed configuration of the element. In the contracted delivery configuration, the device fits inside the delivery catheter.

The bristles may be made of a flexible material such as stainless steel, Elgiloy or Nitinol. Other suitable materials may also be used, such as any suitable polymer or any other shape memory metal or metal alloy. The flow restrictor may be a membrane or a thin film membrane made of a self-expanding material such as a polymer, stainless steel or Nitinol. The core may be made of stainless steel or other suitable material and may comprise a twisted wire from which the bristles extend and on which the flow restrictor is mounted. The stem may alternatively comprise a hollow tube wherein the walls of the hollow tube hold the radially extending bristles in place. For example, the tube may be formed from a heat shrinkable material. Alternatively or additionally, the bristles may be held by the stem using other means such as adhesives.

The diameter of an individual flexible bristle may range from about <NUM> (<NUM> inches) to about <NUM> (<NUM> inches). For example, the diameter of an individual flexible bristle may be about <NUM> (<NUM> inches), about <NUM> (<NUM> inches) or about <NUM> (<NUM> inches). The overall radial diameter of the expanded flexible bristles may range from about <NUM> to about <NUM>.

A flow restrictor may be a membrane made from thin film Nitinol, thin film PTFE, a thin film elastomer such as polyurethane or any other type of suitable biocompatible material. The membrane <NUM> may have a thickness of about <NUM> to about <NUM> and a radial diameter of about <NUM> to about <NUM>. For example, the diameter of the membrane <NUM> may be about <NUM>, about <NUM> or about <NUM>. Furthermore, the membrane <NUM> may be non-permeable or semi-permeable.

<FIG> shows an exemplary embolization device <NUM> in an unconstrained configuration. The embolization device <NUM> comprises a plurality of flexible bristles 40a, 40b having deployed and collapsed configurations. The device may comprise a series of segments (for example, two) wherein the bristles 40a of at least one segment 30a are configured to point distally when deployed in a bodily lumen, and the bristles 40b of at least one segment 30b are configured to point proximally when deployed in a bodily lumen. In some cases, there is only a proximal segment 30a and distal segment 30b. The bristles of each segment 30a, 30b extend radially outwardly from a core, and more specifically stems 20a, 20b.

A proximally pointing segment is defined as a segment in which the bristles point proximally. The proximally pointing segment 30a may comprise a flow restrictor <NUM>. The flow restrictor may be a cone-shaped membrane open at the proximal end or may be another shape such as disc shaped. The flow restrictor <NUM> comprises a hole (not shown) through which the stem 20a passes such that the flow restrictor <NUM> is mounted on the stem 20a. A distally pointing segment is defined as a segment in which the bristles point distally. The flow restrictor <NUM> may alternatively be present on the distally pointing segment and may be a cone-shaped membrane open at the distal end or may be another shape such as a disc shape.

In some examples, at least one segment, such as in the illustrated case the proximal segment 30a, incorporates a flow restrictor <NUM>. The flow restrictor <NUM> is configured to restrict blood flow in the vessel when the device <NUM> is deployed.

In some examples a series of radiopaque markers divides the proximally pointing segment 30a and the distally pointing segment 30b, such as the radiopaque marker <NUM> shows in <FIG>. The radiopaque marker <NUM> may alternatively be positioned proximally to the most proximal segment or distally to the most distal segment, or in between segments. The device may comprise one or more markers <NUM>. There may be a proximal marker (not depicted) positioned proximal to the proximal bristle segment 30a, a distal marker (not depicted) distal to the distal segment 30b, and/or an intermediate marker <NUM> positioned between the proximal bristle segment and the distal segment. In other examples, the device does not comprise any markers.

In some examples the bristles 40a, 40b are formed on respective stems 20a, 20b. In the illustrated example the stems 20a, 20b comprise a twisted metal wire which securely holds the bristles in the twists of the wire. The stems 20a, 20b may alternatively comprise a hollow tube wherein the walls of the hollow tube hold the radially extending bristles in place. For example, the tube may be formed from a heat shrinkable material or a meltable material. Alternatively or additionally, the bristles may be held by the stem using other means such as adhesives.

The stems 20a, 20b may be separately formed and joined by an articulating, flexible or non-articulating joint. For example, in the illustrated example the stems 20a, 20b are connected via the radiopaque marker <NUM> which is securely fastened to the stems 20a, 20b and which is made of an inflexible material. Alternatively, the marker <NUM> may merely be a radiopaque band situated at a location on one of the stems or the joint, and the stems 20a, 20b may be joined by an articulating joint <NUM> such as that shown in <FIG>, a flexible joint <NUM> such as the flexible tube <NUM> of <FIG> which comprises slots to accommodate bending of the tube, or an inflexible joint <NUM> such as that shown in <FIG> which may be a crimping connector. In other examples, the bristle segments may be formed on a single stem and the stem may be more or less flexible at the section joining the bristle segments.

In one case the embolization device comprises only a single proximal segment 30a and a single distal segment 30b. The proximal segment 30a and the distal segment 30b in one case are mounted on a single common stem. The stem 20a of the proximal segment 30a and the stem 20a of the distal segment 30b may form parts of the same continuous stem.

In the case where the device comprises more than two segments, the connection between the two most proximal segments may be stiffer than the distal connections. The distal connections may generally comprise a hinge.

In one example, a flow restrictor <NUM> comprising a flexible membrane is present in at least one of the segments. The membrane may comprise a disc of thin film material. The flexibility of the membrane means its orientation is controlled by the orientation of the adjacent bristles - in the illustrated example, if the adjacent bristles 40a are forced to point distally the membrane will adjust its configuration accordingly. Thus, if the membrane is deployed from a collapsed condition, such as from within a catheter, the bristles will cause it to open up to an expanded configuration. The membrane may also be placed proximal or distal to the segment.

Optionally, the membrane may comprise lines along which the membrane preferentially collapses when it is in the collapsed configuration, so that folding of the membrane in the collapsed configuration is controlled in a predictable manner.

In one case, the embolization device <NUM> comprises at least two segments. In one configuration the flow restrictor <NUM> is in the most proximal segment. This is shown in an unconstrained state schematically in <FIG>. In the configuration shown the flow restrictor <NUM> is located within the proximal segment 30a with bristles 40a both proximal and distal to the flow restrictor <NUM>. In some cases, there may be a distal flow restrictor (not shown), and there may be any number of flow restrictors provided on the embolization device.

The flow restrictor <NUM> may have an outer dimension which is less than an outer dimension of the plurality of anchoring bristles. The flow restrictor may be connected to the stem. In some examples the flow restrictor may have a central hole that is an interference fit on the stem. The central hole in the flow restrictor is preferably smaller than the stem on which it is mounted. The central hole in the flow restrictor may have a diameter which is smaller than the diameter of the stem prior to assembly of the device.

The device <NUM> has a collapsed configuration to facilitate delivery through a catheter. By placing the flow restrictor <NUM> within the bristles 40a of the segment 20a, i.e. with bristles proximal and distal to it, it is protected from damage while the implant is being collapsed or pushed through a catheter. Furthermore, any friction between the catheter and the flow restrictor <NUM> is reduced.

In one configuration, the implant is collapsed such that the bristles 40a of the most proximal segment 30a point proximally, while the bristles 40b of the distal segment 30b or segments point distally. Since the flow restrictor orientation is controlled by the orientation of the bristles, if the flow restrictor <NUM> is within the proximal segment, it will also point proximally. This is shown schematically in <FIG>, with the device <NUM> shown in a collapsed delivery configuration within a delivery catheter <NUM>.

A distal end <NUM> of the catheter <NUM> is positioned at a target location within a bodily lumen, and the embolization device <NUM> is delivered from the catheter <NUM> into the bodily lumen from the distal end. For example, a delivery element (not shown) may be used to push the embolization device <NUM> through the delivery catheter <NUM>. The delivery element may be moved distally relative to the delivery catheter <NUM> to deliver the embolization device <NUM> from the distal end <NUM>.

<FIG> shows the embolization device <NUM> in an expanded deployed configuration within a bodily lumen <NUM>, after being delivered from the distal end <NUM> of the delivery catheter <NUM>. The plurality of flexible bristles anchor the embolization device <NUM> to the bodily lumen <NUM>. A set of bristles 40a are configured to extend radially outwardly from the core and longitudinally in a proximal direction opposite to the distal direction
It can be seen from <FIG> that once the proximal segment 30a is in the expanded deployed configuration, it is difficult to recapture the embolisation device <NUM>. In particular, if the delivery catheter <NUM> is advanced over the proximal bristle segment 30a, the bristles of the proximal segment 30a are forced by the delivery catheter <NUM> into a distal orientation. This can cause damage to the bristles and unwanted reorientation of the bristles. Thus, recapture and redeployment of the embolisation device <NUM> affects the correct functioning of the device in its redeployed position.

<FIG> shows an apparatus comprising an embolisation device <NUM> for promoting clot formation in a bodily lumen <NUM>. The embolisation device <NUM> is shown in an expanded deployed configuration. The embolisation device <NUM> comprises a core <NUM>, more specifically a stem, and a plurality of flexible bristles 400a, 400b, extending outwardly from the core <NUM>, the bristles 400a, 400b having a collapsed delivery configuration and an expanded deployed configuration in which the bristles 400a, 400b extend at least radially outwardly from the core <NUM> to contact the lumen <NUM> and to anchor the device in the lumen <NUM>. The outer portion of the bristles 400a, 400b contact the wall of the lumen <NUM>. The embolisation device <NUM> is configured to be delivered in a distal direction from a delivery catheter <NUM>. In the expanded deployed configuration shown in <FIG>, a set of flexible bristles 400a extend radially outwardly from the core <NUM> and longitudinally in a proximal direction P opposite to the distal direction. The apparatus further comprises a recapture mechanism <NUM> for moving the set of flexible bristles 400a to a lower radial profile than in the expanded deployed configuration. More particularly, the recapture mechanism <NUM> moves the set of flexible bristles 400a to the lower radial profile before the delivery catheter <NUM> is moved over the set of flexible bristles 400a. As such, the recapture mechanism <NUM> is an active recapture mechanism actuatable independently of the movement of the delivery catheter <NUM> over the bristles 400a. It is noted that the embolisation device <NUM> may comprise any of the features of the examples described with reference to <FIG> (type of core, any number of bristle segments, flow restrictor, type of joint between bristle segments and so on). The distally-extending bristles 400b and the flow restrictor <NUM> may be considered as optional.

In the embodiment shown in <FIG>, the apparatus comprises a mesh <NUM> mounted on the core <NUM> and connected to the set of bristles 400a radially outwardly from the core <NUM>. The mesh <NUM> may be fixedly mounted to the core <NUM> (e.g. by welding or adhesive or a frictional fit) or it may be slidably mounted to the core <NUM>. The set of bristles 400a may be fixedly connected to the mesh <NUM> (e.g. by welding or adhesive to the mesh <NUM> at points on the bristles 400a radially outwardly from the core <NUM>), or may be slidably connected to the mesh <NUM> (for example the bristles 400a may pass through holes in the mesh <NUM> from one longitudinal side of the mesh <NUM> to the other longitudinal side of the mesh <NUM>. The mesh <NUM> is configured to be retracted by the recapture mechanism <NUM> in the proximal direction P. In doing so, the bristles 400a are pulled in the proximal direction P and move to a lower radial profile as shown in <FIG>.

In the embodiment show in <FIG>, the recapture mechanism <NUM> comprises a sliding element <NUM> slidably mounted on the core <NUM> proximal to the set of bristles 400a and coupled to the mesh <NUM> via linking elements <NUM> (for example metallic or polymer wires whose respective ends are attached to the sliding element <NUM> and the mesh <NUM>). The sliding element <NUM> may be, for example, a collar, tube, ring or similar slidably mounted on the core <NUM>. The sliding element <NUM> is connected to an elongate element <NUM> (for example a wire, line, ribbon, or similar element configured to extend inside the delivery catheter along some or all the length of the delivery catheter) which extends through the delivery catheter <NUM> and is retractable by a user of the apparatus by a control mechanism. In all embodiments disclosed herein, the control mechanism may be any mechanism which is controllable by the user to retract (and optionally advance) the elongate element(s) through the delivery catheter. For example, the control mechanism may comprise a spool connected to the proximal end of the elongate element(s), rotatable by the user, either manually or by a motor, to wind the elongate element(s). As the elongate element(s) are wound, the elongate element(s) are retracted. The elongate element <NUM> may instead be retracted manually by the user by pulling a proximal end of the elongate element <NUM> in a proximal direction. The elongate element may be, for example, made of nitinol.

In some embodiments, the embolisation device <NUM> comprises a detach element <NUM> which is configured to removably connect to a delivery element <NUM>. In all embodiments disclosed herein, the detach element <NUM> may be any element which removably connects the embolisation device <NUM> to the delivery element <NUM>. The detach element <NUM> may for example be a male or female screw thread on the embolisation device <NUM> configured to removably attach to a counterpart female or male screw thread on the delivery element <NUM>. The detach element <NUM> may be an electrolytic element (formed of, e.g. formed of platinum, stainless steel, nitinol and/or cobalt chromium) configured to disintegrate upon application of an electric current delivered to the electrolytic element via the delivery element <NUM>. The detach element <NUM> may be a connector between the embolisation device <NUM> and the delivery element <NUM> which is configured to break after a predetermined number of rotations. In all embodiments disclosed herein, the delivery element <NUM> may be any elongate element such as a wire, line or ribbon configured to extend through the delivery catheter <NUM>. The delivery element <NUM> is operable to push the embolisation device <NUM> through the delivery catheter <NUM>. The embolisation device <NUM> is deployed to the expanded deployed configuration by moving the delivery element <NUM> distally relative to the delivery catheter (for example by holding the delivery catheter <NUM> and pushing the delivery element <NUM> or by holding the delivery element <NUM> and pulling the delivery catheter). If the embolisation device <NUM> has been deployed in the bodily lumen <NUM> (for example as shown in <FIG>) and must be recaptured, a user of the apparatus may actuate the recapture mechanism <NUM> by retracting the elongate element <NUM> in the proximal direction P (and holding the delivery element <NUM> in place), which retracts the sliding element <NUM> and therefore the mesh <NUM> via the linking elements <NUM>. Doing so causes the bristles 400a to be moved to a lower radial profile as shown in <FIG>. The delivery catheter <NUM> may then be advanced over the bristles 400a without causing damage to the bristles 400a or reorienting them. The recapture mechanism <NUM> may be configured to decrease the radial profile of the set of flexible bristles 400a to a radial profile smaller than an inner radius R of the delivery catheter <NUM> so that they do not abut the delivery catheter <NUM> when being recaptured.

Once the embolisation device <NUM> is recaptured, the delivery catheter <NUM> may be repositioned and the embolisation device <NUM> may be redeployed (for example as shown in <FIG>, at a different position in the lumen <NUM>). The recapture mechanism <NUM> may be reversed (i.e. advanced) to redeploy the bristles 400a or the bristles 400a may have a stiffness which reverse (i.e. advance) the recapture mechanism <NUM> such that the bristles are redeployed if the recapture mechanism <NUM> is not being actuated. The elongate element <NUM> may be detached from the sliding element <NUM> and the delivery element <NUM> may be detached from the detach element <NUM>. The elongate element <NUM> and the delivery element <NUM> may be configured to detach by any suitable detachment mechanism. For example, the elongate element <NUM> and/or the delivery element <NUM> may comprise a male or female screw thread configured to connect to a corresponding female or male screw thread of the sliding element <NUM>/detach element <NUM>. Accordingly, the elongate element <NUM> and/or delivery element <NUM> may be rotated in order to detach from the embolisation device. Alternatively, the elongate element <NUM> and/or the delivery element <NUM> may be attached to the sliding element <NUM> and detach element <NUM>, respectively, and configured to break after a predetermined number of twists/rotations of the element so that they detach from the embolisation device <NUM>. In another alternative, the elongate element <NUM> and/or delivery element <NUM> may be attached to the sliding element <NUM>/detach element <NUM> by an electrolytic element which is operable to disintegrate by electrolysis in the bodily lumen by applying an electric current to the electrolytic element. The electrolytic element may be formed of platinum, stainless steel, nitinol and/or cobalt chromium.

<FIG> shows the apparatus when the elongate element <NUM> and delivery element <NUM> have been detached from the embolisation device <NUM>. The delivery catheter <NUM>, elongate element <NUM> and delivery element <NUM> may then be removed and the embolisation device <NUM> is deployed.

In embodiments where the mesh <NUM> is slidably connected to both the stem <NUM> and the bristles 400a, the elongate element <NUM> may remain connected to the mesh <NUM> when being retracted. In particular, the elongate element <NUM> may retract the sliding element <NUM> and the mesh <NUM> off the embolisation device <NUM> such that the mesh <NUM> is removed from the embolisation device <NUM> when it is deployed. Accordingly, the mesh <NUM> may remain part of the embolisation device <NUM> when implanted in the lumen <NUM> or it may be removed completely.

The mesh <NUM> may also be connected to a flow restricting membrane <NUM> attached to the core <NUM>, having a collapsed delivery configuration and an expanded deployed configuration. In the expanded deployed configuration, the flow restricting membrane <NUM> extends radially outwardly and longitudinally in a proximal direction P opposite to the distal direction, and the recapture mechanism <NUM> may also be configured to move the flow restricting membrane <NUM> to a lower radial profile than in the expanded deployed configuration. In the embodiment shown in <FIG>, the flow restricting membrane <NUM> is attached to the mesh (e.g. by welding or adhesive) and is therefore also retracted to a lower radial profile when the mesh <NUM> is retracted. In other embodiments the flow restricting membrane is not present or is not connected to the mesh <NUM>, and may be configured to extend longitudinally in a distal direction.

For any embodiments disclosed herein, the mesh <NUM> may be made of a woven metal or polymer. The mesh <NUM> may be made of a shape memory material such as nitinol. The mesh <NUM> may be made of a heat-shrinkable material or a meltable polymer, and may be heat-shrunk or melted onto the bristles such that the bristles 400a are securely attached to the mesh <NUM>. Alternatively, the bristles may be attached to the mesh <NUM> by welding or adhesive. Preferably, the radial profile of the mesh <NUM> in an unconstrained configuration is less than the inner radius of the delivery catheter <NUM>.

Once again, the apparatus comprises a mesh <NUM> mounted on the core <NUM> and connected to the set of bristles <NUM> radially outwardly from the core <NUM>. The mesh <NUM> may be fixedly mounted to the core <NUM> (e.g. by welding or adhesive or a frictional fit) or it may be slidably mounted to the core <NUM>. The set of bristles 400a may be fixedly connected to the mesh <NUM> (e.g. by welding or adhesive to the mesh <NUM> at points on the bristles 400a radially outwardly from the core <NUM>), or may be slidably connected to the mesh <NUM> (for example the bristles 400a may pass through holes in the mesh <NUM> from one longitudinal side of the mesh <NUM> to the other longitudinal side of the mesh <NUM>. The mesh <NUM> is configured to be retracted by the recapture mechanism <NUM> in the proximal direction P and moved to a lower radial profile.

In the embodiment shown in <FIG>, the recapture mechanism <NUM> comprises one or more retractable elongate elements <NUM> attached to the mesh <NUM> and therefore coupled to the bristles 400a via the mesh <NUM>. The elongate elements <NUM> traverse the length of the delivery catheter <NUM> and are operable to be retracted by a user via a control mechanism.

Again, the embolisation device <NUM> may comprise a detach element <NUM> configured to removably connect to a delivery element <NUM>. The delivery element <NUM> is operable to deliver the embolisation device through the delivery catheter <NUM> as described with reference to <FIG>. If the embolisation device <NUM> has been deployed in the bodily lumen <NUM> but must be recaptured, a user of the apparatus may actuate the recapture mechanism <NUM> by retracting the elongate elements <NUM> in the proximal direction P (and holding the delivery element <NUM> in place) which retracts the mesh <NUM>. Doing so causes the bristles 400a to be moved to a lower radial profile (shown in <FIG>). The delivery catheter <NUM> may then be advanced over the bristles 400a without causing damage to the bristles 400a or reorienting them. The recapture mechanism <NUM> may be configured to decrease the radial profile of the set of flexible bristles 400a to a radial profile smaller than an inner radius of the delivery catheter <NUM> so that they do not abut the delivery catheter <NUM> when being recaptured. Again, once recaptured, the embolisation device <NUM> may be redeployed at a new position in the lumen <NUM>. The recapture mechanism <NUM> may be reversed (i.e. advanced) to redeploy the bristles 400a or the bristles 400a may have a stiffness which reverse i.e. advance the recapture mechanism <NUM> such that the bristles are redeployed if the recapture mechanism <NUM> is not being actuated. The elongate elements <NUM> may be detached from the mesh <NUM> and the delivery element <NUM> may be detached from the detach element <NUM>. The elongate elements <NUM>/delivery element <NUM> may be removably connected to the mesh <NUM>/detach element <NUM> by any suitable mechanism. For example, as described above, they may be connected via a screw mechanism, or configured to break off from the mesh <NUM>/detach element <NUM> after a predetermined number of twists/rotations, or they may be attached to the mesh <NUM>/detach element <NUM> via an electrolytic element configured to disintegrate upon application of an electric current through the elongate elements <NUM>/delivery element <NUM>.

As in the case of the embodiments described with reference to <FIG>, in embodiments where the mesh <NUM> is slidably connected to both the stem <NUM> and the bristles 400a, the elongate elements <NUM> may remain connected to the mesh <NUM> when being retracted. In particular, the elongate elements <NUM> may retract the mesh <NUM> off the embolisation device <NUM> such that the mesh <NUM> is removed from the embolisation device <NUM> when it is deployed. Accordingly, the mesh <NUM> may remain part of the embolisation device <NUM> when implanted in the lumen <NUM> or it may be removed completely.

The mesh <NUM> may be made of a metal or polymer. The mesh <NUM> may be made of a shape memory material such as nitinol. The mesh <NUM> may be made of a heat-shrinkable material or a meltable polymer, and may be heat-shrunk or melted onto the bristles such that the bristles 400a are securely attached to the mesh <NUM>. Alternatively, the bristles may be attached to the mesh <NUM> by welding or adhesive.

In the embodiment shown in <FIG>, the apparatus does not comprise a mesh. Rather, the recapture mechanism <NUM> comprises a sliding element <NUM> slidably mounted on the core <NUM> proximal to the set of bristles 400a and coupled to the bristles 400a via linking elements <NUM> (for example wires whose respective ends are attached to the sliding element <NUM> and the bristles 400a). The linking elements <NUM> may each be fixedly attached to one or more bristles at a point radially outwardly from the core <NUM>, or they may be slidably connected to the bristles (for example the linking elements may comprise loops slidably receiving one or more bristles 400a through the loops). The sliding element <NUM> may be, for example, a collar slidably mounted on the core <NUM>. The sliding element <NUM> is connected to an elongate element <NUM> which extends through the delivery catheter <NUM> and is retractable by a user of the apparatus via a control mechanism.

Again, the embolisation device <NUM> may comprise a detach element <NUM> configured to removably connect to a delivery element <NUM>. The delivery element <NUM> is operable to deliver the embolisation device through the delivery catheter <NUM> as described with reference to <FIG>.

If the embolisation device <NUM> has been deployed in the bodily lumen <NUM> but must be recaptured, a user of the apparatus may actuate the recapture mechanism <NUM> by retracting the elongate element <NUM> in the proximal direction P (and holding the delivery element <NUM> in place) which retracts the sliding element <NUM>. Doing so pulls the linking elements <NUM> in a proximal direction, which causes the bristles 400a to be moved to a lower radial profile (shown in <FIG>). The delivery catheter <NUM> may then be advanced over the bristles 400a without causing damage to the bristles 400a or reorienting them. The recapture mechanism <NUM> may be configured to decrease the radial profile of the set of flexible bristles 400a to a radial profile smaller than an inner radius of the delivery catheter <NUM> so that they do not abut the delivery catheter <NUM> when being recaptured. Again, once recaptured, the embolisation device <NUM> may be redeployed at a new position in the lumen <NUM>. The recapture mechanism <NUM> may be reversed (i.e. advanced) to redeploy the bristles 400a or the bristles 400a may have a stiffness which reverse (i.e. advance) the recapture mechanism <NUM> if the recapture mechanism <NUM> such that the bristles are redeployed is not being actuated. The elongate element <NUM> may be detached from the sliding element <NUM> and the delivery element <NUM> may be detached from the detach element <NUM>. The elongate element <NUM>/delivery element <NUM> may be removably connected to the sliding element <NUM>/detach element <NUM> by any suitable mechanism. For example, as described above, they may be connected via a screw mechanism, or configured to break off from the sliding element <NUM>/detach element <NUM> after a predetermined number of twists/rotations, or they may be attached to the sliding element <NUM>/detach element <NUM> via an electrolytic element configured to disintegrate upon application of an electric current through the elongate element <NUM>/delivery element <NUM>.

In embodiments where the linking elements <NUM> are slidably connected to the bristles 400a, the elongate element <NUM> may remain connected to the sliding element <NUM> when the elongate element <NUM> is retracted. In particular, the elongate element <NUM> may slide the linking elements <NUM> off the bristles 400a and the sliding element <NUM> off the core <NUM> (and over detach element <NUM>) such that the sliding element <NUM> and linking elements <NUM> are removed from the embolisation device <NUM> when it is deployed. Accordingly, the sliding element <NUM> and linking elements <NUM> may remain part of the embolisation device <NUM> when implanted or may be removed completely.

The linking elements <NUM> may be attached to the bristles by welding or adhesive, or by a heat shrinkable or meltable material, and the heat shrinkable material may be heated or melted to be secured to the bristles 400a. For example, as shown in <FIG>, the linking elements <NUM> and one or more bristles 400a may extend through a heat-shrinkable material <NUM>. For example, the heat-shrinkable material may be a tube, with the linking element <NUM> extending through the lumen defined by the tube wall of the material <NUM>, and one or more bristles may extend through the tube wall. When heat is applied to the material <NUM>, the material <NUM> shrinks to hold the linking element <NUM> and one or more bristles 400a securely. It is noted that any two components of the embolisation systems disclosed herein may be connected by such a heat shrinkable material, or via a meltable material which is melted around the components to securely attached them to each other.

The linking elements <NUM> may also be connected to a flow restricting membrane <NUM> attached to the core <NUM>, having a collapsed delivery configuration and an expanded deployed configuration. In the expanded deployed configuration, the flow restricting membrane <NUM> extends radially outwardly and longitudinally in a proximal direction P opposite to the distal direction, and the recapture mechanism <NUM> may also be configured to move the flow restricting membrane <NUM> to a lower radial profile than in the expanded deployed configuration. In the embodiment shown in <FIG>, the flow restricting membrane <NUM> is attached to one or more of the linking elements <NUM> (e.g. by welding or adhesive) and is therefore also retracted to a lower radial profile when the sliding element <NUM> is retracted. In other embodiments the flow restricting membrane <NUM> is not present or is not connected to the mesh <NUM>, and may be configured to extend longitudinally in a distal direction.

In the embodiment shown in <FIG>, the recapture mechanism <NUM> comprises a plurality of retractable elongate elements <NUM> which are each directly coupled to one or more of the bristles 400a at a point radially outwardly of the core <NUM>. The elongate elements <NUM> may be slidably coupled or attached to the bristles 400a. For example, the elongate elements <NUM> may comprise loops slidably receiving one or more bristles 400a through the loops. For example, as shown in <FIG>, an elongate element <NUM> comprises a loop <NUM> which slidably receives one or more bristles 400a. The elongate elements traverse the length of the delivery catheter <NUM> and are operable to be retracted by a user via a control mechanism.

The embolisation device <NUM> may comprise a detach element <NUM> configured to removably connect to a delivery element <NUM>. The delivery element <NUM> is operable to deliver the embolisation device through the delivery catheter <NUM> as described with reference to <FIG>.

If the embolisation device <NUM> has been deployed in the bodily lumen <NUM> but must be recaptured, a user of the apparatus may actuate the recapture mechanism <NUM> by retracting the elongate elements <NUM> in the proximal direction P (and holding the delivery element <NUM> in place) which retracts the bristles 400a and causes the bristles 400a to be moved to a lower radial profile (shown in <FIG>). The delivery catheter <NUM> may then be advanced over the bristles 400a without causing damage to the bristles 400a or reorienting them. The recapture mechanism <NUM> may be configured to decrease the radial profile of the set of flexible bristles 400a to a radial profile smaller than an inner radius of the delivery catheter <NUM> so that they do not abut the delivery catheter <NUM> when being recaptured. Again, once recaptured, the embolisation device <NUM> may be redeployed at a new position in the lumen <NUM>. The recapture mechanism <NUM> may be reversed (i.e. advanced) to redeploy the bristles 400a or the bristles 400a may have a stiffness which reverse (i.e. advance) the recapture mechanism <NUM> such that the bristles are redeployed if the recapture mechanism <NUM> is not being actuated. The elongate elements <NUM> may be detached from the bristles 400a and the delivery element <NUM> may be detached from the detach element <NUM>. The elongate elements <NUM>/delivery element <NUM> may be removably connected to the bristles 400a/detach element <NUM> by any suitable mechanism. For example, as described above, they may be connected via a screw mechanism, or configured to break off from the bristles 400a/detach element <NUM> after a predetermined number of twists/rotations, or they may be attached to the bristles 400a/ detach element <NUM> via an electrolytic element configured to disintegrate upon application of an electric current through the elongate elements <NUM>/delivery element <NUM>. In embodiments where the elongate elements <NUM> are slidably connected to the bristles 400a, the elongate elements <NUM> may retract so that they slide off the bristles 400a the elongate elements <NUM> are removed from the embolisation device <NUM> when it is deployed.

The elongate elements <NUM> may each be attached to one or more of the bristles by welding or adhesive, or the elongate elements <NUM> may comprise a heat shrinkable or meltable material, and may be heated or melted to be secured to the bristles 400a.

The elongate elements <NUM> may also be connected to a flow restricting membrane <NUM> attached to the core <NUM>, having a collapsed delivery configuration and an expanded deployed configuration. In the expanded deployed configuration, the flow restricting membrane <NUM> extends radially outwardly and longitudinally in a proximal direction P opposite to the distal direction, and the recapture mechanism <NUM> may also be configured to move the flow restricting membrane <NUM> to a lower radial profile than in the expanded deployed configuration. In the embodiment shown in <FIG>, the flow restricting membrane <NUM> is attached to one or more of the elongate elements <NUM> (e.g. by welding or adhesive) and is therefore also retracted to a lower radial profile when the elongate elements are retracted. In other embodiments the flow restricting membrane <NUM> is not present or is not connected to the mesh <NUM>, and may be configured to extend longitudinally in a distal direction.

In any of the embodiments of <FIG>, the recapture mechanism <NUM> may be connected to the mesh <NUM> at a plurality of points distributed circumferentially about the mesh (for example the attachment points of the linking elements <NUM> or elongate elements <NUM> may be distributed about the mesh such that the retracting force of the mechanism is distributed about the mesh. This configuration avoids preferentially pulling the mesh <NUM> by the recapture mechanism <NUM> on one radial side of the embolisation device (for example if a single connection to the mesh exists on one radial side of the mesh).

In the embodiment shown in <FIG>, the apparatus comprises a collar <NUM> slidably mounted on the core <NUM> distally to the set of bristles 400a. The recapture mechanism <NUM> is configured to retract the collar <NUM> in the proximal direction. Doing so moves the collar <NUM> in a proximal direction, over the bristles 400a, which in turn causes the bristles to be push proximally and move to a lower radial profile. In some embodiments, the collar <NUM> may be a resiliently expandable material, for example an elastic material. The collar <NUM> may comprise materials such as Nylon and/or polyethylene.

In the embodiment shown in <FIG>, the recapture mechanism <NUM> comprises a sliding element <NUM> slidably mounted on the core <NUM> proximal to the set of bristles 400a and coupled to the collar <NUM> via linking elements <NUM> (for example wires whose respective ends are attached to the sliding element <NUM> and the collar <NUM>). The sliding element <NUM> may be, for example, a collar slidably mounted on the core <NUM>. The sliding element <NUM> is connected to an elongate element <NUM> which extends through the delivery catheter <NUM> and is retractable by a user of the apparatus via a control mechanism.

If the embolisation device <NUM> has been deployed in the bodily lumen <NUM> (for example as shown in <FIG>) and must be recaptured, a user of the apparatus may actuate the recapture mechanism <NUM> by retracting the elongate element <NUM> in the proximal direction P (and holding the delivery element <NUM> in place), which retracts the sliding element <NUM> and therefore the collar <NUM> via the linking elements <NUM>. Doing so causes the bristles 400a to be moved to a lower radial profile as shown in <FIG>. The delivery catheter <NUM> may then be advanced over the bristles 400a without causing damage to the bristles 400a or reorienting them. The recapture mechanism <NUM> may be configured to decrease the radial profile of the set of flexible bristles 400a to a radial profile smaller than an inner radius of the delivery catheter <NUM> so that they do not abut the delivery catheter <NUM> when being recaptured.

Once recaptured, the embolisation device <NUM> may be redeployed at a new position in the lumen <NUM>. The recapture mechanism <NUM> may be reversed (i.e. advanced) to redeploy the bristles 400a or the bristles 400a may have a stiffness which reverse (i.e. advance) the recapture mechanism <NUM> such that the bristles are redeployed if the recapture mechanism <NUM> is not being actuated. The elongate element <NUM> may be detached from the sliding element <NUM> and the delivery element <NUM> may be detached from the detach element <NUM>. The elongate element <NUM>/delivery element <NUM> may be removably connected to the sliding element <NUM>/detach element <NUM> by any suitable mechanism. For example, as described above, they may be connected via a screw mechanism, or configured to break off from the sliding element <NUM>/detach element <NUM> after a predetermined number of twists/rotations, or they may be attached to the sliding element <NUM>/detach element <NUM> via an electrolytic element configured to disintegrate upon application of an electric current through the elongate element <NUM>/delivery element <NUM>.

Alternatively, the elongate element <NUM> may not be removable from the sliding element <NUM>, and once the embolisation device <NUM> is correctly deployed, the elongate element can be completely retracted, the sliding element <NUM> and collar <NUM> sliding off the embolisation device (the sliding element <NUM> may be sized to slide over the detach element <NUM>). Accordingly, the sliding element <NUM> and collar <NUM> may remain part of the implanted embolisation device <NUM> or may be removed completely from the implanted device.

In the embodiment shown in <FIG>, the embolisation device <NUM> comprises a flow restricting membrane <NUM>. In the expanded deployed configuration, the flow restricting membrane <NUM> extends radially outwardly and longitudinally in a proximal direction P opposite to the distal direction, and the recapture mechanism <NUM> may also be configured to move the flow restricting membrane <NUM> to a lower radial profile than in the expanded deployed configuration. In other embodiments the flow restricting membrane <NUM> is not present or is located distally to the collar <NUM>, and may be configured to extend longitudinally in a distal direction.

In the embodiment shown in <FIG>, the apparatus comprises a collar <NUM> slidably mounted on the core <NUM> distally to the set of bristles 400a. The recapture mechanism <NUM> is configured to retract the collar <NUM> in the proximal direction. Doing so moves the collar <NUM> in a proximal direction, over the bristles 400a, which in turn causes the bristles to be pushed proximally and move to a lower radial profile. In some embodiments, the collar <NUM> may be a resiliently expandable material, for example an elastic material. The collar <NUM> may comprise materials such as Nylon and/or polyethylene.

In the embodiment shown in <FIG>, the recapture mechanism <NUM> comprises one or more retractable elongate elements <NUM> attached to the collar <NUM>. The elongate elements <NUM> traverse the length of the delivery catheter <NUM> and are retractable by a user via a control mechanism.

If the embolisation device <NUM> has been deployed in the bodily lumen <NUM> (for example as shown in <FIG>) and must be recaptured, a user of the apparatus may actuate the recapture mechanism <NUM> by retracting the elongate elements <NUM> in the proximal direction P (and holding the delivery element <NUM> in place), which retracts the collar <NUM>. Doing so causes the bristles 400a to be moved to a lower radial profile, similar to that shown in <FIG>. The delivery catheter <NUM> may then be advanced over the bristles 400a without causing damage to the bristles 400a or reorienting them. The recapture mechanism <NUM> may be configured to decrease the radial profile of the set of flexible bristles 400a to a radial profile smaller than an inner radius of the delivery catheter <NUM> so that they do not abut the delivery catheter <NUM> when being recaptured.

Once recaptured, the embolisation device <NUM> may be redeployed at a new position in the lumen <NUM>. The recapture mechanism <NUM> may be reversed (i.e. advanced) to redeploy the bristles 400a or the bristles 400a may have a stiffness which reverse (i.e. advance) the recapture mechanism <NUM> such that the bristles are redeployed when the recapture mechanism <NUM> is not being actuated. The elongate elements <NUM> may be detached from the collar <NUM> and the delivery element <NUM> may be detached from the detach element <NUM>. The elongate elements <NUM>/delivery element <NUM> may be removably connected to the collar <NUM>/detach element <NUM> by any suitable mechanism. For example, as described above, they may be connected via a screw mechanism, or configured to break off from the collar <NUM>/detach element <NUM> after a predetermined number of twists/rotations, or they may be attached to the collar <NUM>/detach element <NUM> via an electrolytic element configured to disintegrate upon application of an electric current through the elongate elements <NUM>/delivery element <NUM>.

Alternatively, the elongate elements <NUM> may not be removable from the collar <NUM>, and once the embolisation device <NUM> is correctly deployed, the elongate elements <NUM> can be completely retracted, the collar <NUM> sliding off the embolisation device <NUM>. Accordingly, the collar <NUM> may remain part of the implanted embolisation device <NUM> or may be removed completely from the implanted device.

In the embodiments shown <FIG>, the recapture mechanism <NUM> may be connected to the collar <NUM> as a plurality of points distributed circumferentially about the collar <NUM> (for example the attachment points of the linking elements <NUM> or elongate elements <NUM> may be distributed about the core such that the retracting force of the mechanism is distributed about the collar <NUM>). This configuration avoids preferentially pulling the collar by the recapture mechanism <NUM> on one radial side of the embolisation device (for example if a single connection to the collar exists on one radial side of the collar).

In any of the embodiments disclosed herein, the some or all of the bristles may comprise hooks or other protrusions <NUM> (see <FIG>) which increase the surface friction of the bristles, inhibiting the retracting mechanism from becoming disconnected from the bristles.

Whilst in the illustrated embodiments, the embolisation device <NUM> is shown as having a detach element <NUM> at a proximal end of the embolisation device <NUM>, it will be appreciated that in other embodiments the embolisation device may not comprise a detach element. For example, in any of the embodiments described herein, the embolisation device may not comprise detach element <NUM> and the embolisation device <NUM> may be pushed through the delivery catheter <NUM> using a pusher <NUM>, which abuts the proximal end of the embolisation device <NUM>, but which is not attached to the embolisation device (for example as shown in <FIG>).

Furthermore, in any of the embodiments described herein, the apparatus may comprise a sliding detach element <NUM> which is both the detach element <NUM> and sliding element <NUM>, as illustrated in <FIG>. In particular, the sliding element <NUM> of any embodiment, in conjunction with the elongate element <NUM>, may be used to deliver the embolisation device <NUM> to the body lumen <NUM>. The embolisation device may comprise stopping elements <NUM> (e.g. protrusions or sections of core <NUM> of a larger diameter) distally and/or proximally to the sliding detach element <NUM> to restrict the extent which the sliding detach element <NUM> may translate along the core <NUM>.

The elongate element <NUM> is operable to push the embolisation device <NUM> through the delivery catheter <NUM>. The embolisation device <NUM> is deployed to the expanded deployed configuration by moving the elongate element <NUM> distally relative to the delivery catheter <NUM> (for example by holding the delivery catheter <NUM> and pushing the elongate element <NUM> or by holding the elongate element <NUM> and pulling the delivery catheter <NUM>). If the embolisation device <NUM> has been deployed in the bodily lumen <NUM> (for example as shown in <FIG>) and must be recaptured, a user of the apparatus may actuate the recapture mechanism <NUM> by retracting the elongate element <NUM> in the proximal direction P, which retracts the sliding element <NUM> and therefore the mesh <NUM> via the linking elements <NUM>. In particular, the retracting mechanism is still able to be retracted due to the opposing anchoring force of the deployed embolisation device within the lumen <NUM>. Doing so causes the bristles 400a to be moved to a lower radial profile. The delivery catheter <NUM> may then be advanced over the bristles 400a without causing damage to the bristles 400a or reorienting them. The recapture mechanism <NUM> may be configured to decrease the radial profile of the set of flexible bristles 400a to a radial profile smaller than an inner radius R of the delivery catheter <NUM> so that they do not abut the delivery catheter <NUM> when being recaptured. Once recaptured, the embolisation device <NUM> may be redeployed at a new position in the lumen <NUM>. The recapture mechanism <NUM> may be reversed (i.e. advanced) to redeploy the bristles 400a or the bristles 400a may have a stiffness which reverse (i.e. advance) the recapture mechanism <NUM> such that the bristles are redeployed if the recapture mechanism <NUM> is not being actuated. The elongate element <NUM> may be detached as described in the above embodiments. Further, if proximal protrusion <NUM> is not provided, all of the components of the recapture mechanism <NUM> (e.g. including the mesh <NUM> or the collar <NUM>) may be completely removed from the implanted device, as described in the embodiments above.

The apparatuses disclosed herein may be provided by the following method:.

The step of providing a recapture mechanism may comprise slidably or fixably connecting the set of bristles to the recapture mechanism.

The recapture mechanism may be connected to the bristles by a heat shrinkable material (for example the elongate elements <NUM> or linking elements <NUM> may be connected to the bristles <NUM> and/or mesh <NUM> by a heat shrinkable material analogous to the configuration shown in <FIG>) and the step of providing the recapture mechanism may comprise slidably receiving the set of bristles through the heat shrinkable material, and heat shrinking the material. Alternatively, the recapture mechanism may be connected to the bristles by a meltable material and the step of providing the recapture mechanism may comprise slidably receiving the set of bristles through the meltable material, and melting the material.

As has been described above, it will be appreciated that there are numerous formulations of the recapture mechanism. It will be appreciated that the recapture mechanism can be any mechanism which is configured to move the set of proximally-extending bristles to a lower radial profile than in the expanded deployed configuration before the delivery catheter is moved over the set of bristles.

All of the above are fully within the scope of the present disclosure and are considered to form the basis for alternative embodiments in which one or more combinations of the above described features are applied, without limitation to the specific combination disclosed above.

Claim 1:
An apparatus comprising:
an embolisation device (<NUM>) for promoting clot formation in a bodily lumen (<NUM>), the embolisation device (<NUM>) comprising a core (<NUM>) and a plurality of flexible bristles (400a, 400b) extending outwardly from the core (<NUM>), the bristles (400a, 400b) having a collapsed delivery configuration and an expanded deployed configuration in which the bristles (400a, 400b) extend at least radially outwardly from the core (<NUM>) to contact the lumen (<NUM>) and to anchor the device (<NUM>) in the lumen (<NUM>), and
a delivery catheter (<NUM>), wherein:
the embolisation device (<NUM>) is configured to be delivered in a distal direction from the delivery catheter (<NUM>) to the lumen (<NUM>);
in the expanded deployed configuration, a set of the flexible bristles (400a) extend radially outwardly from the core (<NUM>) and longitudinally in a proximal direction opposite to the distal direction; and
the apparatus further comprises a recapture mechanism (<NUM>),
characterised in that
the recapture mechanism (<NUM>) is actuatable independently of the movement of the delivery catheter (<NUM>) over the bristles (400a, 400b), for moving the set of flexible bristles (400a) to a lower radial profile than in the expanded deployed configuration before the delivery catheter (<NUM>) is moved over the set of flexible bristles (400a).