Patent Description:
Thrombectomy devices employing a thrombus capture body and a thrombus blocking body are known from <CIT> and <CIT> and comprise an elongated catheter member having a distal part and a proximal part, a thrombus blocking body disposed on the distal part of the catheter member and radially expansible between a contracted orientation and an expanded, thrombus-blocking, orientation, a thrombus capture body disposed on the distal part of the catheter member in an axially spaced-apart relationship to the thrombus blocking body, and radially expansible between a contracted orientation and an expanded, thrombus-capture, orientation having an open leading end for receipt of thrombus, deployment means actuable to deploy and retract the thrombus capture body and thrombus blocking body, and control means operable to provide relative movement between the thrombus capture body and the thrombus blocking body. Specifically, the actuation means of these devices is designed to maintain the thrombus capture body in a stationary position, while moving the thrombus blocking body towards the thrombus capture body. While these devices have shown limited success with removal of short thrombus from blood vessels, they do not adequately remove longer thrombus. This problem is illustrated in Comparative Figures A and B, which shows a blood vessel B containing a long thrombus C, and a device of the prior art located for removal of the thrombus. Actuation of the device causes the blocking member D to move in the direction of arrow E (Fig. A), while the thrombus capture body F remains stationary. It can be seen from <FIG>that, due to the length of the thrombus C, movement of the thrombus blocking member D does not translate to thrombus being pushed into the capture body F, but rather causes the thrombus C to clog up. <CIT> describes a similar thrombectomy device to those described above. <FIG> of this document describes a device having a distal collapsible collector assembly <NUM> that in use is pulled towards the proximal collector assembly <NUM>. A problem associated with this device is that the circumferential edge of the collector <NUM> would catch on any obstacles causing the collector to flare.

<CIT> describes an expansible shearing catheter for thrombus removal. In one embodiment (Fig. <NUM>), the device comprises an expansible occlusion member located distally of the shearing basket that is configured to prevent flow downstream beyond the occlusion member and is located a distance distally of the thrombus. Treatment of the lesion involves pushing the shearing catheter downstream towards and into contact with the thrombus, where the action of the outer basket and inner rotating basket cause the break-up of the thrombus. The use of this embodiment does not involve compression of thrombus between the occlusion body and shearing basket; rather, the occlusion body is located during use a distance from the thrombus and functions to occlude blood flow downstream of the thrombus. <CIT> describes a clot treatment device having an expandable cage with a rotatable core wire attached to the cage at its distal end. <CIT> discloses a thrombectomy device having proximal and distal expandable engaging elements.

It is an object of the invention to overcome at least one of the above mentioned problems.

The Applicant has discovered that the device according to <CIT> in which the shearing basket is located proximal of the thrombus and during use is consequently pushed into contact with the thrombus by an elongated control arm, suffers from reduced force being imposed on the thrombus by the thrombus capturing body due to the bending flexibility of the elongated body. Additionally there is the risk of the control arm buckling during use due to the length of the arm and the stresses applied to the arm when it is pushing the shearing basket into contact with the thrombus. Additionally, in applications when the shearing basket is pushed downstream in the vessel, where the vessel progressively tapers outwardly, the effectiveness of the shearing basket decreases due to the increasing diameter of the vessel. The Applicant has overcome the problems with the device of <CIT>, and the devices of the other prior art documents mentioned above, by providing a thrombectomy device according to the preamble of Claim <NUM>, and in which the thrombus capture body is located distally of the thrombus blocking body. The invention is defined in claims <NUM> and <NUM>. Further embodiments of the invention are defined in the dependent claims.

An embodiment of the invention is illustrated in <FIG>. As the thrombus capture body is located distally of the thrombus blocking body, and as the elongated control arm is operably connected to a leading end of the thrombus capture body, this results in the thrombus capture body being pulled by its leading end into contact with the thrombus. This has the effect of reducing the compression forces exerted on the control arm, and reduces the risk of the control arm bucking. In addition, in applications where the catheter is introduced into a vessel in a downstream direction, the use of a thrombectomy device having a capture body located distally of the blocking body has the advantage that during use the movement of the capture body will be upstream, where the vessel progressively narrows, thereby maintaining contact between the capture body and the wall of the vessel.

Accordingly, in a first aspect, there is provided a thrombectomy device for removing matter from a body lumen, the device comprising:.

In one embodiment, the device includes a control mechanism adapted to vary the force applied by one or both of the thrombus capture cage or blocking body against the vessel wall.

In one embodiment, the control mechanism comprises a biasing element adapted to bias the thrombus capture cage or blocking body into an expanded orientation. This helps maintain contact between the cage and vessel wall, irrespective of whether the cage is being advanced downstream or upstream in the vessel.

In one embodiment, the thrombus capture cage or blocking body are self-expanding.

In one embodiment, the thrombus blocking body is shaped to dovetail with the leading end of the thrombus capture cage. This arrangement facilitates movement of thrombus into the capture cage, and helps ensure that all thrombus is forced into the cage.

In one embodiment, the blocking body is adapted for deformation or reconfiguration upon application of an external force to a shape suitable for dovetailing with the leading end of the cage.

In one embodiment, the external force is the thrombus capture cage abutting the blocking body. In one embodiment, the blocking body includes an axial extension configured to effect deformation or reconfiguration of the blocking body while the capture cage and blocking body are spaced-apart.

In another aspect, the disclosure provides a thrombectomy device for removing matter from a body lumen, the device comprising:.

Preferably, the device comprises rotation means operable to rotate the thrombus capture body about an axis of the catheter member. The Applicant has found that both axial and rotational movement of the capture member achieves better removal of thrombus from the lumen of the vessel. Preferably, the actuation means is operable to rotate the capture member independently of the blocking member.

The cage may be disposed on the distal part of the catheter member either proximally or distally of the thrombus blocking body. Suitably, the cage is located distally of the thrombus capture member.

Typically, the cage comprises an open leading end for receipt of thrombus. The open leading end may comprise a braid or mesh with a mesh size dimensioned to allow thrombus pass into the cage. Preferably, the cage has a substantially closed trailing end, which can be for example a braid or mesh having a mesh size dimensioned for capture of thrombus. In a preferred embodiment, the cage comprises an open leading end comprising a braid or mesh with a mesh size dimensioned to allow thrombus pass into the cage and a substantially closed trailing end comprising a braid or mesh having a mesh size dimensioned for capture of thrombus. The terms "leading end" means the end of the cage facing the blocking member, and the "trailing end" means the end of the cage opposite the leading end.

The thrombus macerator typically comprises a device configured to rotate, for example one or more rotating elements such as wires or brushes configured to come into contact with thrombus located within the cage and dislodge the thrombus and/or break-up the thrombus into smaller particles.

The thrombus extractor may be an extractor tube having an open end disposed within the capture body and adapted to remove thrombus that has gathered within the cage. In one embodiment, the device comprises suction means configured to extract thrombus from the cage through the extractor tube. In another embodiment, the extractor may be a helical screw that extends longitudinally along the catheter member and is configured to deliver thrombus from within the capture body to a proximal end of the device. In another embodiment, the device comprises suction means and a helical screw.

Ideally, the cage comprises a thrombus macerator and a thrombus extractor disposed within the cage. Preferably, the macerator is disposed closer to the trailing end of the cage than the extractor.

Preferably, the cage comprises a circumferential edge configured to scrape thrombus from the body lumen. Typically, the circumferential edge extends radially around the cage. Typically, the circumferential edge extends around the cage at its widest point. Examples of cages having a circumferential edge are described in <CIT>.

Suitably, the blocking body comprises a cage. Ideally, the blocking body comprises a cage having a leading end configured to prevent ingress of thrombus into the cage. The leading may comprise a fine mesh. In another embodiment, the blocking body is an inflatable balloon. In one embodiment, the blocking body is dimensioned to "dove-tail" or overlap in an axial and radial direction with such leading end of the cage. The blocking body may be deformed or reconfigured to allow such overlapping or dove-tailing dimensions before, during or after the engagement of the capturing body and the blocking body. This may be achieved through suitable compliance of the blocking body and or inverting of the blocking body or other means of adjusting the blocking body so that it is capable of achieving an overlap od dove-tail with the capturing body. Embodiments of the blocking body may include radial expansible inflatable bodies or foam, polymer or metallic structures that have sufficient compliance to overlap the capturing body radially and axially during engagement. These embodiments ensures that thrombus located between the cage and the blocking body is forced into the cage by movement of the cage and blocking body together into a dovetail arrangement.

Preferably, the cage is self-expanding. This means that the cage is biased into an expanded configuration and biased to bear against the wall of the lumen. Thus, the cage applies a force (rather than a displacement) against the wall of the lumen and can reduce in size when it encounters an obstruction. The device may include a control mechanism configured to apply a controlled radial force against the wall of the lumen. This may be achieved through the use of shape memory materials such as NiTi alloys and / or through the use of other metal, polymers including but not limited to CoCr, Steel, Ti alloys for construction of the capturing body and or the blocking body. Where this encounters an obstruction, the capture cage navigates through the obstruction.

Typically, the device comprises vibration means including vibration actuation means configured to vibrate at least one of the thrombus capture body, thrombus blocking body, or the catheter body.

Preferably, the vibration means comprises:.

Suitably, the device includes a macerator comprising a rotating macerator member, wherein the vibrational rotating member is operatively connected to the rotating macerator member for rotation therewith.

Typically, the vibrational rotating member is adapted to rotate about an axis that is offset with respect to the longitudinal axis by means of providing sufficient clearance (<FIG>) within the tube that it rotates. Preferably the vibrational rotating member rotates at an angular velocity that is at or close to the catheter's natural frequency such that it resonates. Additionally, a portion of the catheter including the capture body and the blocking body may be induced to resonate.

Alternatively, the vibrational rotating member may be adapted to have a mass imbalance about the central rotation axis, causing vibration (<FIG>). Another alternative is to have a cam feature forcing displacement from the central rotation axis. This may occur at high frequency, causing vibration (both <FIG> could be considered cam features) or at lower frequencies where displacement is more controlled. The device may also comprise a combination of these features that cause vibration, displacement.

The device comprises deployment means actuable to deploy and retract the capture body and the blocking body. Typically, the control means is configured to deploy and retract the capture and blocking bodies independently of each other. In another embodiment, the control means is configured to deploy and retract the capture and blocking bodies together. Various mechanisms for deploying and retracting capture and blocking bodies in catheters are known to the skilled person. For example, when one of the bodies is a cage, two control arms can be employed, a first arm that is connected to a distal end of the cage and a second arm that is connected to a proximal end of the cage, wherein movement of one of the arms relative to the other causes deployment or retraction of the cage. This arrangement is described in <CIT>. In another embodiment, in which one of the bodies is a balloon, a control fluid pumped through a lumen in the catheter can be employed to deploy and retract the balloon. The control fluid may be a liquid or a gas. In another embodiment, the cage, blocking body or both are self-expanding, and in which the deployment means comprises a restraining sheath adapted to cover at least a part of the catheter member and retain the cage, blocking body, or both, in a retracted orientation, whereby removal of the sheath allows the cage, blocking body, or both, expend.

In one embodiment, the capture body, the cage, or both are self-expanding.

In one embodiment, control means adapted to vary the force applied by one or both of the capture or blocking body against the vessel wall is provided. Typically, the control means comprises biasing means (for example a spring means, a constant force spring, a deformable resilient member, or through pneumatic or hydraulic actuation) for biasing each body into an expanded orientation.

The device also includes means for delivering a fluid along the catheter member and releasing the fluid into the cage or between the cage and blocking member or in the blocking member. Thus, the catheter member may comprise a lumen that extends substantially along the length of the catheter member and having a proximal end configured to receive fluid and a distal end configured to release fluid within the cage or between the cage and the blocking member. In one embodiment, the lumen is formed between control arms for the cage. In another embodiment, the device comprises an external sheath in which the catheter member is at least partially disposed within the sheath, wherein the fluid delivery lumen is disposed between the sheath and catheter member.

While not specifically claimed, also described is a method of removing thrombus from a body lumen, which method employs a device according to the invention, the method comprising the steps of: inserting the device having both capture and blocking body in a collapsed orientation into the body lumen containing a thrombus, adjusting the axial or radial position of the device along the body lumen such that one of the capture body and blocking body is located distally of the thrombus and the other of the capture body and blocking body is located proximally of the thrombus, expanding the capture body and blocking body, and moving the thrombus capture body axially towards the thrombus blocking member, whereby thrombus is forced into the thrombus capture member through the open leading end.

The method can include a step of actuating the macerator or extractor during movement of the capture body towards the blocking body.

The method can include a step of actuating the macerator and extractor during movement of the capture body towards the blocking body.

The device can comprise vibration means, wherein the method includes a step of actuating the vibration means during movement of the capture body towards the blocking body.

The invention provides a device suitable for removing matter such a thrombus, especially long thrombus, from a body lumen such as a blood vessel, especially large or tapered blood vessels. The device find particular application in removing thrombus from large or tapered blood veins.

"Thrombus" should be understood to mean a solid or semi-solid or viscous fluid mass, typically attached to a wall of a blood vessel or lumen. "Long thrombus" should be understood to mean a thrombus having an axial length of at least two or three times the vessel diameter.

"Body lumen" primarily means a blood vessel such as a vein or artery but may include other lumen associated with the lymph, respiratory, urology or GI system. Preferably, the body lumen is as large or tapered vein, examples of which include the femoral, iliac and popliteal veins or vena cava, pulmonary veins.

"Thrombus capture body" means a hollow body capable of being expanded or contacted and having a leading end (the end facing the blocking body) that has apertures dimensioned for receipt of thrombus into the body and a trailing end (the end opposite the leading end) that is closed or has apertures dimensioned for receipt of thrombus. The leading end is inwardly tapering and is connected to the control arm at or close to its apex, such that movement of the control arm pushes or pulls (depending on whether the capture body is located distally or proximally of the blocking body) the capture body axially along the body lumen. The capture body may be a cage. The cage may comprise a mesh or braid structure, having a mesh or braid at the leading end configured for receipt of thrombus, and a finer mesh at the trailing end. The apertures/mesh/braid at the trailing end may be configured to allow small particles of thrombus pass out of the cage and retain larger particles of thrombus. The capture body may be formed by a plurality of longtitudinal structural elements (<FIG>), or one or more radial winding elements, or a combination of the two.

"Radially expansible" as applied to the cage or blocking body means that the body is expansible between a contracted orientation and an expanded orientation. Generally the bodies are contracted (collapsed) when they are being inserted and removed from a body lumen, and expanded when the are positioned on either side of a thrombus.

"Move the thrombus capture body axially towards the thrombus blocking member" means that the capture body is moved relative to the body lumen towards the blocking body.

The terms "leading end" and "trailing end" should be understood in the context of the intended direction of axial movement of the cage towards the blocking member. The leading end faces the blocking member, and the trailing end is the opposite end of the cage to the leading end.

"Thrombus macerator" should be understood to mean means operable to break thrombus into smaller particles. Various macerators are envisaged for example macerators having rotating elements that are intended to come into contact with thrombus located within the capture body, for example rotating brushes or blades.

"Thrombus extractor" should be understood to mean a means operable to remove thrombus from the capture body. This may include an extractor tube having an open end disposed within the cage, and optionally suction means configured to apply a negative pressure to the open end of the tube. Other extractors include augers or helical screws.

"Dovetail with the leading end of the thrombus capture cage" means that an end of the blocking body facing the capture cage overlaps with the leading end of the cage in an axial and radial direction. This is shown in <FIG> and <FIG>. In <FIG>, the blocking body when deployed has a shape configured to dovetail with the cage. In <FIG>, the blocking body has a leading portion that abuts the cage and forces the body to deform into a shape adapted for dovetailing with the cage. In a preferred embodiment, the end of the blocking body inverts (as shown in <FIG>). Generally, the shape configured to dovetail with the leading end of the cage is funnel shape.

"Circumferential edge" means an edge that is disposed at least partly circumferentially around the capture body and is configured to cut or shear thrombus from the wall of the body lumen. The edge may be a blade or a wire or a series thereof, for example. The edge is located adjacent to an open end of the capture body such that thrombus dislodged from the wall of the lumen will pass into the open leading end of the capture body.

"Vibration means" should be understood to mean means operable to cause period or random oscillation in the capture body, blocking body, or distal end of the longitudinal catheter member.

The invention will be more clearly understood from the following description of some embodiments thereof, given by way of example only, in which:.

Referring to <FIG>, there is illustrated a thrombectomy device according to the invention and comprising an elongated catheter member <NUM>, a proximal blocking body <NUM> (in this case an inflatable balloon), and a thrombus capture body in the form of a cage <NUM> having an inwardly tapering trailing end <NUM> having a fine mesh and the inwardly tapering leading end <NUM> having a coarse mesh that is adapted for receipt of thrombus into the cage. The device also comprises an extractor tube <NUM> having an open end disposed distal, proximal or within the cage <NUM>, and an extractor in the form of a helical screw <NUM> disposed within the extractor tube and having a distal macerator disposed within the cage <NUM>. A control arm <NUM> is provided for axial movement of the cage <NUM> and is operably connected to the leading end <NUM> of the cage <NUM> to ensure that when the cage is being moved towards the blocking body <NUM> it is pulled from the leading end <NUM> - this helps prevent the cage flaring when it encounters an obstruction. A second control arm <NUM> is attached to the trailing end <NUM> of the cage. Relative movement of the conrol arms <NUM> and <NUM> provides for expansion or contraction of the cage <NUM>. A blocking body control arm <NUM> may also provided for movement of the blocking body axially along the body lumen.

Referring to <FIG>, there is illustrated a thrombectomy device according to an alternative embodiment in which parts identified with reference to the previous embodiment are assigned the same reference numerals. In this embodiment, the cage <NUM> is located proximally of the blocking body <NUM>, and a macerator in the form of wires <NUM> is provided on a rotatable control arm <NUM> forward of the extractor tube <NUM>, whereby rotation of the control arm <NUM> causes the wires to rotate and macerate thrombus within the cage in the proximity of the wires. In this embodiment, suction means or rotation of a screw (not shown) is provided to extract macerated thrombus from the cage through the extractor tube <NUM>. The control <NUM> is operably connected to the leading end <NUM> of the cage <NUM> for movement of the cage again ensuring that the cage is pushed from its leading end <NUM>.

The use of the devices of the various embodiments involve common steps, namely insertion of the device into the vessel in which the thrombus is located, in which both capture and blocking body are in a non-deployed, contracted, orientation. Typically, the devices will be advanced along the vessel along a guidewire which is inserted first by the surgeon. The device is advanced along the vessel until the distal body (cage or blocking body, depending on whether the configuration of <FIG> is employed) has passed through and beyond the thrombus, and the proximal body is located within or proximally of the thrombus. Once in this position, the radially expansible capture and blocking body will be deployed on each side of the thrombus or segment of the thrombus, and the cage is advanced towards the blocking body while the blocking body is kept stationary in an axial direction. The macerator or extractor will be actuated during movement of the capture body so that thrombus captured within the cage is macerated within the cage and extracted from the cage along the catheter body and out of the body.

It will be appreciated that the use of a macerator or extractor allows the device remove long thrombus, as the thrombus collected in the cage during use is continually removed from the cage either by the extractor or it is flushed out of the cage by body fluid. This is not achieved with the devices of the prior art. Moreover, the configuration of the device where the cage has a leading end that is attached to the control arm, ensures that the device will not snag or flare when it encounters an obstruction, but can be pulled past the obstruction.

Referring now to <FIG>, an example method of removing thrombus from a blood vessel will be explained in more detail:.

The device of the disclosure also preferably comprises a cone shaped capture device such that the thrombus is forced into a position close to the cenral axis postion of the catheter where the thrombus is macerated and extracted.

The device of the disclosure also preferably comprises a vibration mechanism that is configured to vibrate the device, the catheter member, or one or both of the capture or blocking body. The vibration mechanism may be employed with devices having one or two radially expansible bodies. The purpose of the vibration mechanism is to cause the catheter or each cage forming part of the device vibrate against the walls of the vessel, which has been shown to improve the removal of thrombus from the walls of blood vessels. <FIG> show a number of different embodiments of the vibration mechanism, all of which employ a rotatable member that is unbalanced, or eccentric, with respect to a longtitudinal axis of the device. Other methods of vibrating the catheter member or capture body will be apparent to a person skilled in the art.

In a first embodiment (<FIG>), the device <NUM> comprises a cage <NUM> and a helical member <NUM> arranged on a rotating shaft <NUM> extending longtitudinally along the device <NUM>. A length <NUM> of the helical member <NUM> and shaft <NUM>, disposed within the catheter member <NUM>, is disposed along an axis that is displaced with respect to the longtitudinal axis of the catheter member, resulting in the length of the helical member <NUM> and shaft <NUM> rotating eccectrically with respect to the longtitudinal axis of the catheter, and thereby causing vibration of the cage. Vibration of the cage helps dislodge thrombus from the walls of the vessel, and thereby assists in removal of thrombus from the vessel.

In a second embodiment (<FIG>), in which parts described with reference to the previous embodiment are assigned the same reference numerals, a coil <NUM> or a number of coils of the helical screw <NUM> is configured eccentrically with respect to the shaft <NUM>, thereby causing vibration of the helical member and consequently vibration of the device including the catheter or each cage forming part of the device.

<FIG> shows a vibration mechanism comprising a cam <NUM>, and is displacement and not weight/force based. Rotation of the cam <NUM> around the centre point <NUM> causes the cage to vibrate in a cyclical manner. High speed rotation cause more significant vibration.

In a forth embodiment (<FIG>), which is similar to the embodiment of <FIG>, the vibration mechanism comprises an unbalanced weight <NUM> configured to rotate about a longtitudinal axis of the catheter member. Rotation of the unbalanced weight causes the cage to vibrate during use.

As described above, various means for deploying the cage and blocking body may be employed, for example pneumatic or hydraulic expansion of balloons or the use of control arms attached to each end of the cage or blocking body, where relative movement of the arms causes the cage or blocking body to expand or collapse. In another embodiment, illustrated in <FIG>, the deployment means comprises a retaining sheath <NUM> shows an embodiment of the device of the invention in which a sheath <NUM> is provided that covers the elongated catheter member <NUM> and keep the cage <NUM> and blocking body (not shown) in an unexpanded orientation. In this embodiment, the device can be actuated to withdraw the sheath thereby allowing the cage and blocking body expand (deploy) to their expanded configuration. Use of this deployments means requires that the cage and blocking body are self-expanding, for example due to an inherent property of the cage or body, for example elasticity.

As described above, the device of the invention may also be employed to deliver liquid agent, for example a thrombolytic agent which can break down thrombus, to the vessel lumen. This may be achieved in a number of different ways including:.

Generally, the liquid agent would be injected into the delivery lumen, which may be any of the above. Alternatively, the liquid agent may be delivered slowly by means of a drip feed, or may be delivered in a number of different ways, for example through a hollow distal arm (which has the advantage of being capable of delivering liquid agent distally of the cage), through a lumen formed between the distal arm and the proximal arm (also referred to as the extractor tube), or through a lumen formed between the proximal arm and the outer sheath.

<FIG> shows an alternative embodiment of the device (similar to the device of <FIG>) in which parts identified with reference to the previous embodiments are assigned the same reference numerals. In this device, the blocking body <NUM> is dimensioned to "dove-tail" or overlap in a radial and axial direction with the inwardly tapering leading end <NUM> of the cage <NUM>. Thus, when the body <NUM> and cage <NUM> are brought together, they can abut closely thus forcing thrombus into the cage <NUM> for maceration or extraction. The blocking body may deform or be actuated to deform to achieve this overlapping configuration. In this embodiment, a lumen for delivery of thrombolytic agent is provided between the blocking body control arm <NUM> and the control arm <NUM> of the cage <NUM>.

<FIG> shows an alternative embodiment of the device in which parts identified with reference to the previous embodiments are assigned the same reference numerals. In this embodiment, the blocking body is adapted to deform into a dovetailing shape upon engagement with the capture body <NUM>. Specifically, the blocking body has an axial extension that projects towards the capture body, and engagment between the leading end of the capture body and the projection causes the blocking body to invert from the shape shown in <FIG> to the shpa eshown in <FIG>. In use the body and cage may then be brought together into a dovetailing arrangement (as shown in <FIG>) or they may be maintained in a spaced-apart, nonoverlapping, arrangement.

In another embodiment, the capturing body and the blocking body may operatively connected to elongated catheter member <NUM> and or control arm <NUM>. Inversion or collapsing of the blocking body or the capturing body causes the distance between the capturing body and the blocking body to be reduced such that they can abut closely thus forcing thrombus into the cage <NUM> for maceration or extraction. In another embodiment, the inversion or collapsing of the blocking body or the capturing body causing the distance between the capturing body and the blocking body to be reduced such that the thrombus is engaged or trapped between the blocking body and capturing body for subsequent extraction from the body.

Claim 1:
A thrombectomy device for removing matter from a body lumen, the device comprising:
an elongated catheter member (<NUM>) having a distal part and a proximal part;
an axially stationary thrombus blocking body (<NUM>) disposed on the distal part of the catheter member (<NUM>) and radially expansible between a contracted orientation and an expanded, thrombus-blocking, orientation;
a thrombus capture cage (<NUM>) disposed on the distal part of the catheter member (<NUM>) in an axially spaced-apart relationship to the axially stationary thrombus blocking body (<NUM>), and radially expansible between a contracted orientation and an expanded, thrombus-capture, orientation;
deployment means (<NUM>) actuable to deploy and retract the thrombus capture cage (<NUM>) and thrombus blocking body (<NUM>), and
an elongated control arm (<NUM>) connected to the thrombus capture cage (<NUM>),
wherein
the thrombus capture cage (<NUM>) is located distally of the axially stationary thrombus blocking body (<NUM>) and a thrombus extractor (<NUM>) and/or macerator mechanism (<NUM>) is disposed within the thrombus capture cage (<NUM>) and wherein the thrombus capture cage (<NUM>) comprises an inwardly tapering leading end (<NUM>) facing the axially stationary blocking body (<NUM>) having apertures for receipt of thrombus into the capture cage (<NUM>) and the elongated control arm (<NUM>) is operably connected to the leading end (<NUM>) of the thrombus capture cage (<NUM>) to pull the thrombus capture cage (<NUM>) axially proximally along the body lumen towards an abutting configuration with the axially stationary thrombus blocking body (<NUM>).