Handling device

Abstract

The present disclosure relates to a handling device for a guidewire. The handling device comprises a housing configured such that the guidewire extends at least partially through the housing, a valve for receiving the guidewire such that the guidewire passes through the valve in a longitudinal direction. The valve and the housing are arranged such that the guidewire exits the housing through the valve, and a holder is positioned outside the housing and configured to grasp the guidewire outside the housing.

Description

[0001] Handling device

[0002] Technical Field

[0003] The present disclosure relates to a handling device for a guidewire . Further, the present disclosure concerns a catheter assembly comprising the handling device , and a thrombectomy or atherectomy assembly comprising the catheter assembly .

[0004] Background

[0005] In connection with the handling of a guidewire , it is often desirable to capture and / or fix the guidewire so as to avoid inadvertent repositioning or shi fting of the guidewire during a procedure . However, during the procedure , it may be desired to change the relative position between the guidewire and another entity, such as a medical device , e . g . a catheter . Therefore , it may be necessary to manipulate the guidewire during the procedure , such as to fix the guidewire relative to the medical device or to move the guidewire relative to the medical device . Often, a second user or assistant is necessary to assist the primary user with the handling of the guidewire .

[0006] Summary

[0007] The present disclosure aims at improving prior art devices with respect to avoidance of errors and mistakes in connection with the guidewire and at improving the handling of the guidewire .

[0008] According to the present disclosure , a handling device for a guidewire is provided, wherein the handling device comprises a housing configured such that the guidewire extends at least partially through the housing, a valve for receiving the guidewire such that the guidewire passes through the valve in a longitudinal direction, wherein the valve and the housing are arranged such that the guidewire exists / leaves the housing via / through the valve , and a holder provided / positioned outside / external to the housing and directly or indirectly (via other entities connecting the holder and the housing) on a housing surface , and configured to grasp / capture / hold the guidewire outside the housing .

[0009] Accordingly, a valve separates the inside of the housing from the outside , and the guidewire extends from inside of the housing to the outside via the valve . Outside the housing ( external to the inside of the housing, i . e . not in an inner lumen defined by the housing) , a holder is positioned, the holder positioned at the housing and configured to grasp / capture the guidewire outside the housing ( external to the inside of the housing, i . e . not in an inner lumen defined by the housing) , so as to hold the guidewire . Hence , the holder is ( directly or indirectly) connected to the housing, but is positioned outside of a housing lumen .

[0010] As the guidewire is held outside housing, visual inspection of the guidewire in the holder may be facilitated, at least to some extent . Also , the handling in connection with the guidewire , i . e . capturing of the guidewire , may be improved, as the holder can be accessed from the outside and manipulation in connection with holding of the guidewire is improved . Hence , by placing the holder outside the housing and grasping the guidewire outside of the housing, the handling of the guidewire may be less prone to errors . In particular, it may be visually detected and identi fied i f the guidewire is inappropriately held in the holder . Also , a user may precisely and immediately intervene i f an inappropriate capture of the guidewire or an inadvertent release of the guidewire out of the holder is detected . Generally, the holder grasps the guidewire, which means that the guidewire is held by the holder or captured by the holder. The holder does not necessarily fix the guidewire completely, i.e. prohibit any movement, but holding of the guidewire may allow for some movement of the guidewire relative to the holder, in particular if a force to move the guidewire relative to the holder is exerted on the guidewire, such as by the user's hands.

[0011] At the same time, the valve may reliably separate the inside of the housing from the outside, which means that the exit of the guidewire from the inside of the housing to the outside is not prone to leakage. Thus, by way of the valve, a reliable use of the handling device is supported.

[0012] Inside the housing, blood and / or clot may be present, and it may need to be avoided that blood leaks out of the housing. This is a main purpose of the valve. Generally, the valve may be regarded as providing a seal while allowing the guidewire to exit the housing via the valve.

[0013] The valve may additionally contribute to holding / grasping of the guidewire. In particular, when the holder switches from holding to releasing the guidewire or vice versa, a contribution of the valve to the holding of the guidewire may be expedient. Accordingly, by way of the holder and the valve, sufficient fixation or restriction of movement of the guidewire may be achieved. For example, if the user does not grasp the guidewire, the valve may hold the guidewire in place .

[0014] As the holder is connected to the housing (such as to a surface of the housing) , the holder is directly or indirectly positioned on the housing and is held by the housing. Accordingly, it may not be necessary for a second user (e.g. surgeon) or assistant to assist the primary user (e.g. surgeon) with the handling of the guidewire during a procedure , such as with holding of the guidewire . Speci fically, another guidewire holder freely held in the hand of an assistant may no longer be necessary . However, it may nevertheless be desired to have an assistant or second user assisting the primary user during a procedure in connection with the guidewire .

[0015] Optionally, the valve is a haemostasis valve . Such valves are configured to control blood flow or fluid comprising blood . Such valves assist in appropriate sealing of the inside of the housing relative to the outside .

[0016] Optionally, the holder and the valve are arranged relative to each other such that a virtual connecting line between the holder and the valve extends along the longitudinal direction . In other words , the holder and the valve may be aligned along the longitudinal direction . As the guidewire passes through the valve in a longitudinal direction, the alignment of the holder and the valve along the longitudinal direction supports that the guidewire , which extends between the holder and the valve , extends straight in the longitudinal direction . This improves the handling, makes it less complicated and less prone to kinks in the guidewire .

[0017] Optionally, the valve is positioned at a rear side of the handling device . During use , the handling device has a rear side which can be identi fied as the side pointing away from the subj ect ( e . g . patient ) during use , e . g . , away from the treatment area, towards the user . A front side of the handling device may be defined as the side facing towards the subj ect during use , and is opposite to the rear side . The valve at the rear side of the handling device supports a straight extension of the guidewire through the handling device , as the guidewire usually enters the handling device , in particular the housing thereof , at the front side . In some embodiments , a holder facilitating a straight extension of the guidewire is preferable . This may mean that the holder is located such that the guidewire is not bent between the housing, the valve and / or the holder. Also, this may mean that the guidewire is not bent by the holder, e.g. inside the holder .

[0018] The valve is, optionally, configured to open towards the outside of the housing. Further optionally, the valve is configured to open substantially in the longitudinal direction, towards the outside of the housing. This may mean that the valve opens towards the holder. This is preferable as the guidewire passes through the valve in the longitudinal direction, so that the guidewire passes through the valve on a straight line (e.g. without bends) . As the guidewire opens towards the outside, the valve can open if the pressure inside the housing is too high. As such, the valve may also or simultaneously act as a pressure release valve for releasing high pressure inside the housing.

[0019] Optionally, the holder is positioned behind the valve, when viewed in the longitudinal direction during use. As the holder is positioned outside of the housing, while the valve separates the housing from the outside, and the valve is positioned at a rear side of the device, the holder may be positioned behind the valve, meaning further rearwards of the handling device. In this regard, the holder may be regarded as further away from the subject than the valve during use. When viewed from the user during use, i.e. during a procedure, the holder is positioned upstream of the valve (e.g., closer to the user) , which means that when viewed in the longitudinal direction during use, the guidewire is, firstly, held in the holder and, secondly, passes through the valve .

[0020] Optionally, the holder is indirectly arranged on the outer surface of the housing. Hence, the holder does not need to be directly placed on the outer surface of the housing, but the holder may be indirectly positioned on the outer surface of the housing . The holder may be fixed to the housing such that the holder may not be freely movable relative to the housing . Such arrangement may facilitate use of the holder, as the holder does not need to be held by the user or an assistant , but is held by the housing .

[0021] Optionally, the holder is manually manipulatable . Accordingly, the holder may have two di f ferent configurations , such as an open configuration in which the guidewire may be inserted or moved relative to the holder, and a closed configuration in which the guidewire is captured by the holder . Manipulation means that the configuration of the holder is changed with the user ' s hand ( s ) . This facilitates easy handling of the holder .

[0022] Optionally, the holder is configured to hold the guidewire through a friction fit . A friction fit is a measure to grasp / capture the guidewire while avoiding kinking or other damage to the guidewire when it is held by the holder . Friction or form fits are conceivable .

[0023] The holder may generally be stationary relative to the housing, but parts of the holder may move so as to facilitate capturing and releasing of the guidewire .

[0024] Optionally, the holder is configured to be manipulated to switch between an open configuration in which the guidewire is moveable relative to the housing, and a closed configuration in which the guidewire is restricted to move relative to the housing or the holder .

[0025] Accordingly, handling of the guidewire and of the holder is improved . Speci fically, a user can choose to switch from the open to the closed or from the closed to the open configurations as needed . In the closed configuration, the guidewire does not need to be completely fixed relative to the holder, but it may be suf ficient to only restrict the movement between the guidewire and the holder, without completely prohibiting a relative moveability . Speci fically, a restriction of the movement may mean that forces between the guidewire and the holder need to be overcome to move the guidewire relative to the holder while the holder is in the closed configuration .

[0026] Optionally, the holder comprises two opposing surfaces for catching or grasping the guidewire between these opposing surfaces . Two opposing surfaces , speci fically i f arranged such that the interface between the surfaces extends in the longitudinal direction, allow for ef ficient and reliable grasping of the guidewire .

[0027] Optionally, the holder comprises an elastic part , such as a rubber, and is configured such that the holder restricts movement of the guidewire through contact between the elastic part and the guidewire . In this embodiment , the guidewire is held by elastic parts , such as two opposing surfaces comprising elastic material . The elastic properties of the elastic part support a friction fit of the guidewire within the holder, wherein, at the same time , external forces may allow for movement of the guidewire relative to the handling device . Hence , by way of the external forces , a friction fit between the elastic part and the guidewire can be overcome , or at least frictional forces can be compensated by manual interaction .

[0028] Optionally, the holder comprises a biased actuator configured to fix the guidewire by way of the bias and to release the guidewire by way of actuation . By way of the bias , the guidewire is grasped by the actuator and maintained in the closed configuration of the holder . An open configuration of the holder is achieved i f the actuator is actuated so as to overcome the bias and to release the guidewire . This represents a convenient way to allow for manual manipulation of the holder so as to switch from the open to the closed configuration, i.e. from a captured or fixed guidewire to a substantially freely moveable guidewire.

[0029] Optionally, the actuator is manually releasable. In an embodiment, the bias originates from a spring, and by manually pressing an actuator, the spring is compressed so that the bias is overcome and the guidewire is released.

[0030] Optionally, the valve has at least two flaps and is configured to have a closed configuration in which the flaps enclose the guidewire at least partially. The valve may have two flaps, and for example, may be a duckbill valve. Other embodiments of a valve having more than two flaps are conceivable, such as cross-valve, a duckbill-umbrella- combination valve, or the like. Alternative valves are also possible, such as a dilatable valve, a Tuohy Borst valve, or the like. Accordingly, the valve is configured to appropriately seal the inside of the housing from the outside .

[0031] The valve is, optionally, configured to open towards the outside of the housing if the pressure inside the housing exceeds a predetermined pressure. Accordingly, the valve may serve a second purpose, namely as a pressure equalization means. Specifically, if the valve is configured to open at a specific, predetermined pressure, such pressure representing a threshold for the housing to withstand, the valve serves as pressure equalization means.

[0032] Optionally, in particular if the valve is configured to open when a predetermined pressure is exceeded, the handling device may be free from another, i.e. a second valve, in particular free from another haemostasis valve.

[0033] The handling device may be a handle or at least a part of a handle. Accordingly, the handling device is configured to be held by the user in his / her hand . Speci fically, the handling device may be a reusable part of a handle .

[0034] Optionally, the handle is configured for bimanual operation by a single user . This means that the handle may allow for the use by a single person having two hands , in particular without the need for an assistant or second user .

[0035] Speci fically, in an embodiment , this may mean that the holder is configured to be manipulated by a single hand of the user, the user holding in one hand the handle and with the other hand manipulating the guidewire and the holder .

[0036] The present disclosure also concerns a catheter assembly comprising the handling device of the disclosure . The catheter assembly comprises the guidewire and a catheter . The catheter is connected to the handling device substantially at a side of the housing opposite of the valve . Put di f ferently, the catheter is connected to the handling device at the front side of the housing, while the valve is at the rear side of the housing . In other words , the valve and the catheter are provided at opposite sides of the handling device and of the housing thereof .

[0037] Optionally, the valve is positioned at a rear side of the housing and the catheter extends / pro j ects from the housing at a front side of the housing . This means that the guidewire can basically follow a straight line from the catheter, at least where the catheter extends from the housing, to the valve .

[0038] The present disclosure also concerns a thrombectomy or atherectomy assembly, further comprising a rotatable helix extending at least partially within the catheter . By way of the rotatable helix, blood and clot can be aspirated and conveyed from the treatment area towards the outside . Optionally, the guidewire is receivable within the rotatable helix and inside the catheter . A stator and optionally a rotor may be provided at a distal end of the catheter ; the stator stationary to the catheter, the rotor rotatable relative to the catheter . Optionally, the rotor and the stator each comprise an opening for aspiration of blood and / or clot .

[0039] Brief Description of Drawings

[0040] Fig . la schematically depicts a handle , according to one or more embodiments of the present disclosure ;

[0041] Fig . lb schematically depicts an open configuration of the valve of Fig . la ;

[0042] Fig . 1c schematically depicts a handle , according to one or more embodiments of the present disclosure .

[0043] Figs . 2a, 2b, 2c and 2d schematically depict embodiments of a holder of the present disclosure .

[0044] Fig . 3 schematically depicts a valve , according to one or more embodiments of the present disclosure .

[0045] Fig . 4 shows an atherectomy or thrombectomy system, according to one or more embodiments of the present disclosure .

[0046] Fig . 5 shows a distal end of a catheter of an atherectomy assembly, according to one or more embodiments of the present disclosure .

[0047] Fig . 6a to 6c schematically depict engagement mechanisms of the disclosure .

[0048] Detailed Description Fig. la generally depicts a handle 1 according to one or more embodiments. Such handle 1 may include a handling device la for a guidewire 2. The handling device la may be a singleuse device or may be reusable. In Fig. la, the handle 1 consists of the handling device la.

[0049] In Fig. 1c, the handle 1 comprises the upper handling device la and additionally a lower, second part lb. The handling device la of the handle 1 of Fig. lb may be disposable, and the reusable, second part lb may be removably coupled to the handling device la, so as to form the handle 1 in Fig. 1c. The following disclosure not only applies to a handle 1, but equally to a handling device la forming the handle 1 together with a second part lb.

[0050] The handle 1 comprises a housing 3, wherein the guidewire 2 extends at least partially through the housing 3. A valve 4 receives the guidewire 2 such that the guidewire 2 passes through the valve 4 in a longitudinal direction L. The valve

[0051] 4 and the housing 3 are arranged such that the guidewire 2 exits / enters the housing 3 through the valve 4. The valve 4 is coupled to the housing 3. The valve 4 may be captured and surrounded by the housing 3. The valve 4 may be regarded as forming a part of surface of the housing 3.

[0052] A holder 5 is positioned outside the housing 3 and configured to grasp the guidewire 2 outside the housing 3. The holder 5 is positioned on an outer surface 3a of the housing 3. The holder 5 may be integral with the housing 3, while the holder

[0053] 5 is outside of the housing.

[0054] As can be seen in Fig. la, the holder 5 is positioned rearwards to the valve 4, i.e. further to the left side in Fig. 1. The valve 4 is positioned at a rear side R of the handling device 1. As such, the holder 5 is positioned behind the valve 4, when viewed in a longitudinal direction L during use, by the user. Put differently, when looking in the direction opposite to the L direction, the holder 5 is in front of the valve 4 .

[0055] The valve 4 may be a haemostasis valve , which seals the inside of the housing 3 from the outside . The housing 3 may define a lumen of the housing 3 , i . e . a lumen inside the housing 3 . The lumen is sealed by the valve 4 .

[0056] The handle 1 as shown in Fig . la is free from another valve and does in particular not comprise another haemostasis valve than the valve 4 .

[0057] The handle 1 may be held by a user with a single hand . The holder 5 may be manipulated with the other hand of the user . Accordingly, the handle 1 may be configured such that a single user can hold the handle and manipulate the holder 5 with his / her hands . However, also an assistant may take care of the manipulation of the holder and the handling of the guidewire .

[0058] Fig . la also shows a catheter 11 , the catheter 11 emerging / exiting from the housing 3 at its front side F . Accordingly, the catheter 11 is connected to the handling device at the side of the housing 3 which is opposite to the valve 4 . Put di f ferently, the valve 4 is positioned at the rear side R of the housing 3 and the catheter 11 extends from the housing 3 at the front side F .

[0059] The guidewire 2 extends from the outermost rear part of the housing 3 through the holder 5 and through the housing 3 , wherein at the front end of the housing 3 , the guidewire 2 runs within the catheter 11 .

[0060] As indicated in Fig . la, the holder 5 and the valve 4 extend along the longitudinal direction L . They are both positioned on a virtual connecting line V extending along the longitudinal direction L, as indicated in Fig . lb . In other words, the holder 5 and the valve 4 are positioned one after the other.

[0061] Optionally, a distance or gap between the holder 5 and the valve 4 is about 5 to 30 mm, further optionally between 8 to 15 mm. In one embodiment, the distance may be about 10 mm.

[0062] Figs. 2a-2c show a number of embodiments of the holder 5. Specifically, the holder 5 is positioned on an outer surface 3a of the housing 3 and is directly or indirectly arranged on the outer surface 3a of the housing 3. As such, the holder 5 may be integral with the outer surface 3a of the housing 3. The holder 5 may be in direct contact with the outer surface 3a, as shown in Fig. 2d. The holder 5 may be indirectly connected to the outer surface 3a of the housing 3 via posts 20, as shown in Fig. 2a, 2b and 2c. The holder 5 may be glued, welded or the like to the housing 3.

[0063] In Fig. 2a, the holder 5 is arranged on the outer surface 3a of the housing 3, via the posts 20. The holder 5 includes two opposing surfaces 6, wherein the guidewire 2 runs between these opposing surfaces 6. In Fig. 2a, the open configuration of the holder 5, i.e. of the opposing surfaces 6, is shown. Here, the opposing surfaces 6 are angled relative to one another. In the closed configuration of this holder 5 (shown in Fig. 2b) , the opposing surfaces 6 are closed and opposite to each other. The opposing surfaces 6, thus, capture the guidewire 2 along the longitudinal direction L. The transition between the open and closed configurations of the holder 5 may be initiated manually. For example, the user may squeeze the opposing surfaces 6 together for closing the holder 5 and capturing the guidewire 2 by the holder 5.

[0064] The holder 5 establishes a friction fit to hold the guidewire 2 in place or to at least reduce its moveability relative to the holder 5. Friction may occur between the opposing surfaces 6 and the guidewire 2 , when the opposing surfaces 6 are opposite to each other in the closed configuration depicted in Fig . 2b, with the guidewire 2 between the opposing surfaces 6 .

[0065] The holder 5 can switch between the open configuration in which the guidewire 2 is moveable relative to the housing 3 , and the closed configuration in which the guidewire 2 is restricted to move relative to the housing 3 . The holder 5 can be manipulated to switch between the open and closed configurations , in particular manually manipulatable . E . g . the user may manually squeeze the opposing surfaces 6 .

[0066] Fig . 6a to 6c schematically depict exemplary mechanisms to fix and maintain the holder 5 in a closed configuration, i . e . to avoid inadvertent return to the open configuration . The guidewire 2 is not shown in these figures .

[0067] Fig . 6a shows the opposing surfaces 6 in the open configuration, wherein one of the opposing surfaces 6 comprises a clasp 24 at its outermost end . The clasp 24 engages , i f the opposing surfaces 6 are closed, the other opposing surface 6 and thus avoids that the opposing surfaces 6 are inadvertently opened . It is , of course , possible to release the engagement between the clasp 24 and the other opposing surface 6 upon manual interaction .

[0068] Alternatively, as shown in Fig . 6b, instead of the clasp 24 , fastener buttons 25 may be provided at the opposing surfaces 6 . Fig . 6b shows two pairs of fastener buttons 25 , each pair consisting of a fastener button 25a on one opposing surface 6 and a counterpart 25b on the other opposing surface 6 . The fastener button 25a and the counterpart 25b engage with each other upon manual compression and can be separated manually again . As a further alternative, as shown in Fig. 6c, the housing 3 may have a groove 26 in the outer surface 3a. The groove 26 is configured to accommodate at least partially the holder 5, i.e. its opposing surfaces 6, in the closed configuration and to, thus, bias the opposing surfaces 6 towards each other. This maintains the closed configuration of the holder 5, as shown in Fig. (2) of Fig. 6c: The holder 5 may comprise (e.g. elastic) posts 20 attached to the bottom of the groove 26. At least one opposing surface 6 comprises a tag 27. The tag 27 projects from the groove 26 when the holder 5 is received in the groove 26 and, thus, facilitates manual retraction of the holder 5 out of the groove 26 and return to the open configuration (shown in Fig. (1) of Fig. 6c) .

[0069] In the embodiment of Fig. 2c, the holder 5 comprises two opposing surfaces 6 (pads) which catch the guidewire 2 inbetween. Fig. 2c depicts the holder 5 when looking in the longitudinal direction L. The opposing surfaces 6 each comprise an elastic part 7 (such as rubber) , wherein the elastic part is in contact with the guidewire 2. Hence, the elastic part sandwiches the guidewire 2 inbetween. This may increase the friction between the opposing surfaces 6 and the guidewire 2. In this configuration, the holder 5 may not need to have an open configuration but may only have the closed configuration as shown in Fig. 2c, wherein the guidewire 2 is guided along a slit or passage through the elastic parts 7.

[0070] Alternatively or additionally, the opposing surfaces 6 may establish an S-path in the view shown in Fig. 2c. In this regard, the straight line representing a substantially planar interface between the two opposing surfaces 6 shown in Fig. 2c would be S-shaped. in an S-shaped embodiment, no elastic material may be needed.

[0071] The embodiment of Fig. 2d shows a biased actuator 8 configured to hold the guidewire 2 by way of the bias and to release the guidewire 2 by way of actuation. The biased actuator 8 may comprise a biasing member 9 and a first surface 21 against which the biasing member 9 is urged . The biasing member 9 is connected to a second surface 22 at the end of the biasing member 9 . Hence , the first 21 and second 22 surfaces may engage the guidewire 2 when the surfaces 21 and 22 are pressed against each other . The biasing member 9 is a spring and acts on the guidewire 2 by pressing the guidewire 2 against the surface 21 . The actuator 8 does not directly engage the guidewire 2 , but the actuator 8 may indirectly engage the guidewire 2 via the spring 9 . When the actuator 8 is pressed downwards , the spring 9 is compressed and no longer presses the guidewire 2 against that surface 21 . Accordingly, the guidewire 2 is free to move relative to the actuator 8 and the holder 5 . In this embodiment , there may be an opening 23 , such as a slot , for loading the guidewire 2 into the actuator 8 , optionally sideways , i . e . perpendicular to the extension of the guidewire 2 .

[0072] Fig . 3 shows a valve 4 within the outer surface 3a of the housing 3 . The valve 4 has two flaps 10 and is configured to have a closed configuration, as shown in Fig . 3 , in which the flaps 10 enclose around the guidewire 2 . The guidewire 2 may be surrounded completely or may be surrounded at least partially by the flaps 10 . For example , the flaps 10 may be hal f-circles , as shown in Fig . 3 . The flaps 10 may ensure the guidewire 2 is entirely captured by the flaps 10 , so that the valve 4 is substantially closed and sealed so as to avoid leakage out of the housing 3 despite the presence of the guidewire 2 through the valve 4 .

[0073] The valve 4 is configured to open towards the outside of the housing 3 . Fig . la shows the valve 4 in the closed configuration .

[0074] Fig . lb shows the valve 4 in the open configuration, wherein the ends of the flaps 4a, 4b of the valve 4 have been pivoted in the direction opposite the longitudinal direction L . The valve 4 may open at a specific threshold pressure inside the housing 3. If the pressure inside the housing 3 exceeds a predetermined pressure, the valve 4 can open and, accordingly, act as a pressure equalization means. For example, (relative) threshold pressures may be between 0.2 to 2.0 bar, optionally at about 0.5 bar, above the ambient pressure (i.e. above 1 bar) .

[0075] Fig. 4 shows a thrombectomy or atherectomy system, wherein a catheter 11 and its distal end Ila are indicated. The guidewire 2 exits the catheter 11 at the catheter's distal end Ila. The handle 1 is formed by the housing 3. In embodiments, a motor 13 is positioned within the handle 1 (the second part lb of the handle, if the handle comprises a reusable part) . In some embodiments, the system includes a control unit 14, which is optionally separate from the handle 1, or may be housed within the handle 1. An optional foot switch 15 is also shown in Fig. 4. Part of the thrombectomy or atherectomy assembly is also a collection bag 16 for collecting the removed tissue and bodily fluid.

[0076] The motor 13 is for rotating a helix 12 of the catheter assembly. Fig. 5 shows the helix 12 extending through the catheter 11. Accordingly, the rotatable helix 12 extends at least partially within the catheter 11. The guidewire 2 is received within the helix 12 and inside the catheter 11.

[0077] At the catheter's distal end Ila, a stator 19 and a rotor 17 are provided. The rotor 17 is rotatable around the stator 19. Both the rotor 17 and the stator 19 have an opening, wherein the opening 18 of the rotor 17 is shown in Fig. 5. Through these openings, clot and blood can be aspirated.

[0078] During a treatment, the following steps may be performed:

[0079] - Getting access to the subject's vasculature, introducing the guidewire and placing it beyond the treatment area, placing the catheter 11 at the targeted position, i.e. the treatment area.

[0080] - Move the catheter 11 over the guidewire 2. The guidewire 2 will be pushed through the valve 4. During this step, the guidewire 2 will not be clamped in the holder 5.

[0081] - When reaching the starting position for the treatment with the catheter 11, the guidewire 2 can be clamped in the holder 5. After clamping the guidewire 2, it should be ensured that the guidewire 2 can be pushed further distal (the guidewire 2 will move together with the catheter 11) . Optionally, the holder 5 may be released by manipulating the holder 5 so as to achieve the open configuration of the holder 5 and to move the guidewire 2 and the handle 1 / handling device la relative to each other, in particular to move the guidewire 2 relative to the catheter 11. To do so, the user may manipulate the holder 5 by manually opening the opposing surfaces 6 of the embodiment of Fig. 2a / 2b; or by pressing the actuator 8 of the embodiment of Fig. 2d.

[0082] - Perform the treatment. Continuously check the progress, i.e. the position, of the catheter 11 and of the guidewire 2. If the guidewire 2 is located too far distal, open the holder 5 and retract the guidewire 2 to the desired position. Then close the holder 5 and continue with the treatment.

[0083] - After finishing the treatment, open the holder 5 and retract the catheter 11 while keeping the guidewire 2 in its position. Alternatively, the holder 5 can remain closed and the guidewire 2 can be retracted together with the handle 1 (i.e. with the catheter 11) .

[0084] Reference signs

[0085] 1 handle la handling device lb second part of handle

[0086] 2 guidewire

[0087] 3 housing

[0088] 3a outer surface of housing

[0089] 4 valve

[0090] 4a, b flaps

[0091] 5 holder

[0092] 6 opposing surfaces

[0093] 7 elastic part / rubber

[0094] 8 actuator

[0095] 9 biasing member

[0096] 10 flap

[0097] 11 catheter

[0098] I la distal end

[0099] 12 helix

[0100] 13 motor

[0101] 14 control unit

[0102] 15 foot switch

[0103] 16 collection bag

[0104] 17 rotor

[0105] 18 opening

[0106] 19 stator

[0107] 20 post

[0108] 21 first surface

[0109] 22 second surface

[0110] 23 slot

[0111] 24 clasp

[0112] 25a, b fastener button and counterpart

[0113] 26 groove

[0114] 27 tag

[0115] V virtual connecting line L longitudinal direction

[0116] R rear side

[0117] F front side

Claims

AMENDED CLAIMS received by the International Bureau on 13 March 2024 (13.03.2024)1. Thrombectomy or atherectomy assembly comprising a catheter assembly having a handling device for a guidewire, the handling device (1) comprising: a housing (3) configured such that the guidewire (2) extends at least partially though the housing (3) , a valve (4) for receiving the guidewire (2) such that the guidewire (2) passes though the valve (4) in a longitudinal direction (L) , the valve (4) and the housing (3) arranged such that the guidewire (2) exits the housing (3) though the valve (4) , a holder (5) provided outside of the housing (3) and connected to the housing (3) and configured to hold the guidewire (2) outside the housing (3) , the thrombectomy or atherectomy assembly further comprising a guidewire (2) and a catheter (11) , wherein the catheter (11) is connected to the handling device (1) substantially at a side of the housing (3) opposite the valve (4) and further comprising a rotatable helix (12) extending at least partially within the catheter (11) .

2. Thrombectomy or atherectomy assembly of claim 1, wherein the valve is a haemostatis valve.

3. Thrombectomy or atherectomy assembly of claim 1 or 2, wherein a virtual connecting line (V) between the holder (5) and valve (4) extends along the longitudinal direction (L) .

4. Thrombectomy or atherectomy assembly of any of the preceding claims, wherein the valve (4) is positioned at a rear side (R) of the handling device (1) .

5. Thrombectomy or atherectomy assembly of any of the preceding claims, wherein the valve (4) is configured to open25AMENDED SHEET (ARTICLE 19)towards the outside of the housing, optionally substantially in the longitudinal direction (L) .

6. Thrombectomy or atherectomy assembly of any of the preceding claims, wherein the holder (5) is positioned behind the valve (4) , when viewed in the longitudinal direction (L) during use.

7. Thrombectomy or atherectomy assembly of any of the preceding claims, wherein the holder (5) is directly or indirectly arranged on the outer surface (3a) of the housing (3) .

8. Thrombectomy or atherectomy assembly of any of the preceding claims, wherein holder (5) is manually manipulatable between an open configuration and a closed configuration .

9. Thrombectomy or atherectomy assembly of any of the preceding claims, wherein the holder (5) is configured to hold the guidewire (2) by means of a friction fit.

10. Thrombectomy or atherectomy assembly of any of the preceding claims, wherein the holder (5) is configured to be manipulated to switch between an open configuration in which the guidewire (2) is moveable relative to housing (3) , and a closed configuration in which the guidewire (2) is restricted from movement relative to the housing (3) .

11. Thrombectomy or atherectomy assembly of any of the preceding claims, wherein the holder (5) comprises two opposing surfaces (6) for catching the guidewire (2) inbetween .

12. Thrombectomy or atherectomy assembly of any of the preceding claims, wherein the holder (5) comprises an elastic part (7) , optionally comprising rubber, and is configured such that the holder (5) restricts movement of the guidewire26AMENDED SHEET (ARTICLE 19)(2) through contact between the elastic part and the guidewire .

13. Thrombectomy or atherectomy assembly of any of the preceding claims, wherein the holder (5) comprises a biased actuator (8) configured to fix the guidewire (2) by way of the bias and to release the guidewire (2) by way of actuation .

14. Thrombectomy or atherectomy assembly of claim 13, wherein the biased actuator (8) is manually releasable, optionally to compress a biasing member (9) , such as spring.

15. Thrombectomy or atherectomy assembly of any of the preceding claims, wherein the valve (4) has at least two flaps (10) and is configured to have a closed configuration in which the flaps (10) enclose the guidewire (2) at least partially .

16. Thrombectomy or atherectomy assembly of any of the preceding claims, wherein the valve (4) is configured to open towards the outside of the housing (3) if the pressure inside the housing (3) exceeds a predetermined pressure.

17. Thrombectomy or atherectomy assembly of any of the preceding claims, wherein the handling device (1) is free of another valve, in particular free of another haemostasis valve .

18. Thrombectomy or atherectomy assembly of any of the preceding claims, the handling device being at least a part of a handle, optionally a re-useable part of a handle.

19. Thrombectomy or atherectomy assembly of any of the preceding claims, wherein the handle is configured for bimanual operation by a single user.27AMENDED SHEET (ARTICLE 19)20. Thrombectomy or atherectomy assembly of one of the preceding claims, wherein the valve (4) is positioned at the rear side (R) of the housing (3) and the catheter (11) extends from the housing (3) at a front side (F) .

21. Thrombectomy or atherectomy assembly of one of the preceding claims, wherein the guidewire (2) is receivable within the rotatable helix (12) and inside the catheter (11) .

22. Thrombectomy or atherectomy assembly of one of the preceding claims, further comprising a stator (19) having an opening at a distal end (Ila) of the catheter (11) for aspiration of blood and / or clot, optionally further comprising a rotor (17) rotatable relative to the stator, the rotor comprising an opening for aspiration of blood and / or clot .28AMENDED SHEET (ARTICLE 19)

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