Catheter device including an over-travel stop mechanism and / or a re-cover limiting mechanism

Abstract

The invention relates to a catheter device (1) for implanting a medical implant (2). According to the invention, the catheter device (1) comprises an actuating element (5) configured to move together with a balloon (4) of the catheter device and to be manually operated to bring the actuating element (5) from a first state to a second state, wherein the catheter device (1) further comprises a first stop (6) configured to limit the movement of the actuating element (5) and the balloon (4) in a first direction, such as a proximal direction (P), when the actuating element (5) is in the first state, and / or a second stop (7) configured to limit the movement of the actuating element (5) and the balloon (4) in a second direction, such as a distal direction (D), when the actuating element (5) is in the first state, thereby preventing the balloon (4) from being pressed against the catheter tip (8) of the catheter device (1) and / or the balloon stop (31) of the catheter device (1).

Description

Technical Field

[0001] The present invention relates to catheter devices for implanting medical implants, in particular prosthetic heart valves, such as aortic prosthetic heart valves. Background Art

[0002] Such catheter devices generally include a capsule for receiving an implant, such as a self-expanding aortic artificial heart valve, when the implant is in a contracted / curled state. The capsule covers an implant (such as a self-expanding aortic artificial heart valve) placed on a connector, which is connected to the inner sheath / shaft of the catheter device, while the capsule is connected to the outer sheath / shaft. The sliding of the outer sheath / shaft relative to the inner sheath / shaft allows the capsule to move relative to the inner sheath / connector, thereby allowing the self-expanding medical implant to be deployed and release the implant from the connector. In particular, medical implants such as artificial heart valves such as aortic artificial heart valves can be partially deployed and can be retracted into the capsule for repositioning the implant so that it is located at a suitable implantation position. Re-inserting the medical implant into the capsule is generally referred to as "re-sheathing". However, only when the medical implant is still connected to the catheter device, it is possible to re-sheath.

[0003] For example, moving the balloon too far in the proximal direction may result in an undesired release of the medical implant, while moving the balloon too far in the distal direction may introduce overstroke in the coaxial sheath / shaft of the catheter device, which may increase the stiffness of the sheath / shaft and / or result in component misalignment (e.g., the balloon moves over the catheter tip and, e.g., the cross profile changes). In addition, in some cases, component compression may occur.

[0004] In view of the above, if the catheter device has an alternative arrangement, the same applies, which means that moving the balloon too far in the distal direction may lead to an undesired release of the medical implant, while moving the balloon too far in the proximal direction may introduce overtravel in the coaxial sheath / shaft of the catheter device, which may increase the stiffness of the sheath / shaft and / or lead to component misalignment. Furthermore, in some cases, component compression may also occur in this situation. Summary of the invention

[0005] The problem to be solved by the present invention is therefore to provide a catheter device capable of preventing the occurrence of at least one of the above-mentioned difficulties and ideally allowing prevention of unwanted release of the implant, thereby allowing controlled re-sheathing and avoiding the introduction of said "over-travel" and / or misalignment of the catheter device components.

[0006] Among other things, this problem is solved by the catheter device proposed in the present disclosure. Preferred embodiments are set forth in the following description. Other embodiments of the present invention can be derived from the following consecutively numbered embodiments.

[0007] A catheter device for implanting a medical implant is disclosed, comprising:

[0008] - self-expanding medical implants, such as self-expanding aortic prosthetic heart valves,

[0009] - connectors for holding medical implants,

[0010] - a balloon configured to cover the medical implant when the medical implant is connected to the connector, thereby preventing the medical implant from being released from the connector, wherein the balloon is movable in a first direction relative to the medical implant for deploying the medical implant and for releasing the medical implant from the connector, and wherein the balloon is movable in a second direction (e.g., a distal direction) for re-covering the medical implant before the medical implant is released from the connector.

[0011] In the context of the present invention, the first direction may be the distal direction, whereas the second direction is the opposite, ie the proximal direction.

[0012] According to the present invention, the catheter device comprises an actuating element configured to move with the balloon and to be manually operated to bring the actuating element from a first state to a second state, wherein the catheter device further comprises:

[0013] a first stop configured to limit movement of the actuating element and the balloon in a second direction (e.g. distal direction) when the actuating element is in the first state, thereby preventing the balloon from being pressed against the catheter tip of the catheter device and / or the balloon stop of the catheter device, and configured to allow the actuating element to move past the first stop when the actuating element is in the second state, thereby pressing the balloon against the catheter tip and / or the balloon stop; and / or

[0014] - A second stop configured to limit movement of the actuating element and the capsule in a first direction (e.g., a proximal direction) when the actuating element is in the first state, thereby preventing the medical implant from being released from the connector, and configured to allow the actuating element to move past the second stop when the actuating element is in the second state, thereby allowing the medical implant to be fully deployed and released from the connector.

[0015] The invention thus provides in each case a defined limit which forces the user to consciously overcome the respective limit. In this way, an undesired release or the risk of introducing an overtravel in the system is substantially prevented. The catheter device according to the invention may comprise only one or two of these stops.

[0016] As described above, a general object of the present invention is to allow additional travel paths for a catheter shaft system including a balloon, and therefore an implant, particularly if the catheter shaft system has been bent as described above; for example during re-sheathing.

[0017] In particular, according to one embodiment, a symmetrical button design can be employed that is integrated into the force flow in conjunction with a hard stop coupled to a coaxial sheath / shaft of a catheter device. This concept, as well as other embodiments described herein, can be applied to overtravel stops / limiting mechanisms and re-wrapping limiting mechanisms of the device, which will be described in more detail below.

[0018] Throughout the text, the terms "sheath (one or more)" and "shaft (one or more)" can be used interchangeably. However, in some cases and in the context of the present invention, an "axle" may also be referred to as a "sheath", while a "sheath" does not necessarily have to be configured as a "shaft".

[0019] In the framework of the present invention, thus relating to a catheter device / catheter system, the term "distal" refers to that part or component of the system which is away from the handle of the catheter device or the physician operating the catheter device, whereas the term "proximal" refers to those parts or components which are close to the handle or close to the physician.

[0020] According to an embodiment of the catheter device, the catheter device also includes an outer sheath / shaft connected to the balloon, which extends along the longitudinal axis of the catheter device and surrounds the inner cavity of the outer sheath / shaft, and an inner sheath / shaft extending along the longitudinal axis, wherein the inner sheath / shaft is arranged in the inner cavity of the outer sheath and connected to a connector for supporting / holding the medical implant.

[0021] In addition, according to an embodiment of the catheter device, the catheter device includes a handle for moving the capsule relative to the medical implant, wherein the handle includes a handle core and a rotatable member arranged on the handle core, wherein the rotatable member is operably connected to the capsule, in particular through an outer sheath / shaft, so that the capsule moves in a first direction (e.g., a proximal direction) so that when the rotatable member rotates along the first rotational direction, the capsule is gradually removed from the medical implant, and when the rotatable member rotates along an opposite second rotational direction, the capsule moves back along a second direction (e.g., a distal direction) to re-cover the medical implant.

[0022] According to an embodiment, the handle further comprises a gripping portion for manually holding the handle, wherein the gripping portion is rigidly connected to the handle core.

[0023] Furthermore, according to an embodiment of the catheter device, the actuation element comprises a through hole having a first diameter in the first state of the actuation element and a second, larger diameter in the second state of the actuation element, wherein the handle core preferably extends through the through hole.

[0024] According to an embodiment of the catheter device, the second stop is arranged on the handle core, wherein when the balloon moves in the first direction (e.g. the proximal direction), the actuating element is configured to hit the second stop when the actuating element is in the first state, and to be allowed to move past the second stop in the first direction (e.g. the proximal direction) when the actuating element is in the second state. This is because in the first state, the inner diameter is not sufficient to allow the actuating element to pass the second stop, which is only possible when the actuating element is in the second state (i.e. comprising a larger second diameter).

[0025] In addition, according to an embodiment of the catheter device, the balloon is operably connected to the rotatable member such that when the actuating element hits the second stop, the implant is in a partially expanded state and can be re-wrapped by rotating the rotatable member in a second rotational direction, and such that when the actuating element moves past the second stop in a first direction (e.g., a proximal direction), the medical implant is fully expanded and released from the connector.

[0026] Furthermore, in one embodiment, the first stop is arranged on the handle core, wherein when the capsule moves in a second direction (e.g., a distal direction), the actuating element is configured to hit the first stop when the actuating element is in a first state, and to be allowed to move past the first stop in the second direction (e.g., a distal direction) when the actuating element is in a second state.

[0027] Furthermore, in one embodiment, the balloon is operably connected to the rotatable member such that the distal end of the balloon contacts the catheter tip of the catheter device and such that when the actuating element hits the first stop (and when the medical implant is arranged on / connected to the connector), the balloon completely covers the medical implant and such that when the actuating element moves past the first stop in a second direction (e.g., distal direction), the balloon presses against the catheter tip and / or the balloon stop.

[0028] Furthermore, according to an embodiment of the catheter device, the actuating element comprises a movable first member having a first opening and a movable second member having a second opening, wherein the two movable members are arranged side by side such that an overlapping area of ​​the openings of the two movable members forms a through hole of the actuating element. Furthermore, in particular, each of the two movable members is configured to be manually moved from a first position to a second position, wherein when the first and second members are in the respective first positions, the actuating element is in a first state and the through hole of the actuating element comprises a first diameter, and wherein when the first and second members are in the respective second positions, the actuating element is in a second state and the through hole of the actuating element comprises a second, larger diameter.

[0029] Furthermore, according to an embodiment of the catheter device, each of the two movable members comprises a first part and a relative second part, wherein the respective first part forms a manually pushable button, and wherein the two movable members are arranged relative to each other such that the first part of the first movable member faces the second part of the second movable member, and such that the second part of the first movable member faces the first part of the second movable member.

[0030] Furthermore, according to an embodiment of the catheter device, the catheter device comprises a first spring, e.g. a coil spring, arranged between a first portion of the first movable member and a second portion of the second movable member, and wherein the catheter device comprises a second spring, e.g. a coil spring, arranged between a first portion of the second movable member and a second portion of the first movable member, such that the two first portions (pushable buttons) can be manually pushed toward each other to overcome the restoring force generated by the first and second springs to move the movable members from a first position to their second position.

[0031] Furthermore, according to an embodiment of the catheter device, the first portion of the first movable member includes a recess (e.g., a circular groove) for receiving the first end of the first spring, and wherein the second portion of the second movable member includes a recess (e.g., a circular groove) for receiving the second end of the first spring. Similarly, in one embodiment, the first portion of the second movable member includes a recess (e.g., a circular groove) for receiving the first end of the second spring, and wherein the second portion of the first movable member includes a recess (e.g., a circular groove) for receiving the second end of the second spring. In particular, in the case where a coil spring is used for the first and second springs, the circular groove facilitates holding the ends of the respective springs (e.g., in a form-fitting manner).

[0032] In addition, according to an embodiment of the catheter device, each of the two movable members includes at least one flat guide surface, wherein the at least one flat guide surface of the first movable member is configured to slide along the at least one flat guide surface of the second movable member when the two movable members move from their respective first positions to their respective second positions.

[0033] Furthermore, according to an embodiment, each of the two movable members comprises at least one recess, such as a slot, into which at least one flat guide surface of the other movable member engages, in particular in order to prevent the two movable members from separating when they slide against each other.

[0034] In addition, according to an embodiment of the catheter device, the balloon is connected to a rotatable member via an outer sheath / shaft, wherein the rotatable member includes a first internal thread engaged with an external thread formed on a handle core, so that when the rotatable member rotates in a first rotational direction, the rotatable member and the balloon move in a first direction (e.g., a proximal direction), and when the rotatable member rotates in a second rotational direction, the rotatable member and the balloon move in a second direction (e.g., a distal direction).

[0035] In addition, according to one embodiment, the catheter device includes a sliding member to which the inner sheath is connected (the sliding member is in turn connected to the connector), wherein the sliding member is arranged in the inner cavity of the handle core and includes an external thread, which is configured to engage with a second internal thread of the rotatable member, so that when the rotatable member rotates in a first rotational direction, the sliding member and the connector (medical implant) move in a second direction (e.g., a distal direction), and so that when the rotatable member rotates in the second rotational direction, the sliding member and the connector (medical implant) move in a first direction (e.g., a proximal direction).

[0036] Furthermore, according to a preferred embodiment, the medical implant is an artificial heart valve, such as an aortic artificial heart valve, which may include the self-expanding stent for carrying the artificial valve. Furthermore, the valve may include valve leaflets (e.g., three valve leaflets) that may be connected to the stent. The valve leaflets may be formed by biological tissue.

[0037] Thus, in one embodiment, the artificial heart valve is configured to replace the aortic heart valve. Preferably, the catheter device is a TAVI / TAVR catheter device, i.e., a catheter device for transcatheter aortic valve implantation (TAVI) or transcatheter aortic valve replacement (TAVR), respectively. Here, the catheter device can be configured to deliver the artificial heart valve transfemorally (on the thigh) or transapically (through the heart wall) or subclavian (under the clavicle) or directly aortically (through a minimally invasive surgical incision into the aorta) or transostially (through a vein on the thigh from a temporary hole in the aorta near the navel). BRIEF DESCRIPTION OF THE DRAWINGS

[0038] In the following embodiments of the present invention, further features and advantages of the present invention will be described with reference to the accompanying drawings, in which:

[0039] Figure 1 A schematic diagram of an embodiment of a catheter system according to the invention is shown, the catheter system comprising a first stop and an actuating element for forming an overtravel limitation, wherein Figure 1 In the embodiment of the present invention, the overtravel limit has not been reached, allowing free movement between the inner and outer sheaths of the catheter device;

[0040] Figure 2 Shows Figure 1a device wherein an overtravel limit has been reached such that the balloon contacts a balloon stop connected to the inner sheath and an end of the balloon contacts a catheter tip of the device;

[0041] Figure 3 Shows Figure 1 and 2 Schematic plan view of an actuation element shown in , wherein the actuation element is in a first state and is thus capable of engaging with a stop member of a catheter device to provide, for example, overtravel limitation;

[0042] Figure 4 The second state is shown Figure 3 an actuating element, wherein the actuating element has an enlarged inner diameter so as to be able to pass through a stopper of the catheter device;

[0043] Figure 5 Shows Figure 1 and Figure 2 Device, wherein here the actuating element is exemplarily moved in the distal direction past a stop defining an overtravel limit, so that the inner sheath and the outer sheath are stressed;

[0044] Figure 6 Another embodiment of a catheter device according to the present invention is shown, the catheter device including first and second stops providing an overtravel limit and a rewrapping limit, wherein the rewrapping limit is reached and further movement of the balloon in an exemplary proximal direction is not possible without releasing the medical implant;

[0045] Figure 7 Shows Figure 6 An embodiment wherein the re-wrapping limitation is overcome such that the sheath can be moved until complete release of the medical implant is accomplished;

[0046] Figure 7 a shows an example of a medical implant in the form of an exemplary aortic prosthetic heart valve, which can be implanted with a catheter device according to the invention;

[0047] Figure 8 A handle of an embodiment of a catheter device according to the invention is shown, the handle comprising a first stop defining an overtravel limit, a second stop defining a rewrapping limit, and an actuation element comprising a button for passing the respective limit;

[0048] Fig. 9 Shows Figure 8 Details of the handle shown;

[0049] Fig.10 An embodiment of an actuating element of a catheter device according to the invention is shown;

[0050] Fig.11A further embodiment of an actuating element of a catheter device according to the invention is shown, comprising an increased guide surface; and

[0051] Fig.12 A further embodiment of an actuation element of a catheter device according to the invention is shown, which actuation element comprises a guide surface (see emphasized parts therein). DETAILED DESCRIPTION

[0052] Figure 1 A method for implanting a medical implant 2 (e.g. Fig. 7A The catheter device 1 also includes a device for holding the medical implant 2 ( Figure 1 The present invention relates to a connector 3 (not shown in the figure), and a capsule 4, which is configured to cover the medical implant 2 when the medical implant 2 is arranged on the connector 3, thereby preventing the medical implant from being released from the connector 3, wherein the capsule 4 can be moved in a proximal direction P relative to the medical implant 2, for unfolding the medical implant 2 and for releasing the medical implant 2 from the connector 3, and wherein the capsule 4 can be moved in a distal direction D, for re-wrapping the medical implant 2 before the medical implant 2 is released from the connector 3.

[0053] The catheter device 1 preferably includes an outer sheath / shaft 10 having a distal end connected to the balloon 4. The outer sheath / shaft 10 extends along the longitudinal axis x of the catheter device 1 and surrounds the lumen 11 of the outer sheath / shaft 10. The catheter device 1 preferably also includes an inner sheath / shaft 12 extending along the longitudinal axis x, wherein the inner sheath / shaft 12 is arranged in the lumen 11 of the outer sheath / shaft 10 and is connected to the connector 3. The connector 3 in turn can be connected to the catheter tip 8 by a conduit 32. In particular, the catheter tip 8 can include an opening formed in the distal end of the catheter tip 8, so that a guidewire for guiding the catheter device 1 during implantation of the implant 2 can extend in the guidewire lumen included by the inner sheath 12 and the conduit 32, and exit the guidewire lumen via the opening of the catheter tip 8. In particular, the coaxial sheaths / shafts 10, 12 are flexible so that they can follow the tortuous route of the blood vessel through which the implant is transported to the implantation site.

[0054] Furthermore, the catheter device 1 comprises an actuating element 5 configured to move together with the balloon 4 and to be manually operated to bring the actuating element 5 from the first state to the second state, and a first stop 7 configured to limit the movement of the actuating element 5 and the balloon 4, exemplarily in the distal direction D, when the actuating element 5 is in the first state, so as to prevent the balloon 4 from pressing against the catheter tip 8 of the catheter device 1 and / or against the balloon stop 31 of the catheter device 1. Furthermore, the first stop 7 is configured to allow the actuating element 5 to move past the first stop 7 in the distal direction D when the actuating element 5 is in the second state, so as to press the balloon 4 against the catheter tip 8 and / or the balloon stop 31, which introduces loads into the coaxial sheaths 10, 12.

[0055] Thus, the first stop 7 defines an overtravel limit when the inner jacket 10 and the outer jacket 12 are in a defined position relative to each other.

[0056] In particular, the catheter device 1 / balloon 4 is closed when the distal end 4a of the balloon 4 contacts the proximal portion of the catheter tip 8, which corresponds to the position when the actuating element 5 contacts the first stop 7 (see Figure 2 ). The special configuration here is that the capsule stopper 31 and the capsule 4 also meet at this position.

[0057] like Figures 1 to 4 As shown, the actuating element 5 may include two first parts 51a, 52a, which form buttons 51a, 52a (so-called "safety buttons"), which can be assembled in a mirror-symmetrical manner. The overlap between the two movable annular members 51, 52 forming the two buttons 51a, 52a creates a through hole 50, through which the handle core 130 of the handle 13 of the catheter device 1 can be guided. The two buttons 51a, 52a can be spring-loaded so that they are always tightly located on the surface of the handle (e.g., the rotatable member 131), corresponding to the first state of the actuating element 5. When the actuating element 5 abuts against the first stop 7, the buttons 51a, 52a can be pushed toward each other to increase the inner diameter of the through hole 50 (the second state of the actuating element 5), so that they can pass over the larger outer diameter of the first stop 7 formed on the handle core 130 (see Figure 4 ).

[0058] like Figures 1 to 4 as well as Figures 10 to 12 As shown, each of the two movable members 51, 52 arranged side by side to create a through hole 50 when overlapping between the respective openings 510, 520 of the respective members 51, 52 further includes a second portion 51b, 52b opposite to the respective first portion 51a, 52a.

[0059] In this regard, the two movable members 51, 52 of the actuating element 5 are positioned relative to each other such that the first portion 51a of the first movable member 51 faces the second portion 52b of the second movable member 52, and such that the second portion 51b of the first movable member 51 faces the first portion 52a of the second movable member 52 (at Figures 10 to 12 , components 51, 52 are shown separately and not arranged side by side).

[0060] In order to force the movable members 51, 52 to adopt the first position corresponding to the smaller inner diameter D1 of the through hole 50 (the first state of the actuating element 5), see e.g. Figure 3 and Figure 4 , the actuating element 5 comprises a first spring 53 (e.g. a coil spring) arranged between a first portion 51a of the first movable member 51 and a second portion 52b of the second movable member 52, and a second spring 54 (e.g. a coil spring) arranged between the first portion 52a of the second movable member 52 and the second portion 51b of the first movable member 51, so that the two first portions 51a, 52a forming the push buttons 51a, 52a of the actuating element 5 can be manually pushed toward each other to move each of the two movable members 51, 52 from its first position to the second position against the restoring force generated by the first and second springs 53, 54. In the second position corresponding to the second state of the actuating element 5 (see Figure 4 ), the through hole 50 of the actuating element includes a larger inner diameter D2, which allows the actuating element 5 to pass through the first stopper 7 (or the second stopper 6 further described below).

[0061] The springs 53 , 54 can also be formed by a rubber element or by an extruded part having high elasticity.

[0062] like Figure 5 As shown, manipulating the actuation element 5 (e.g., pushing buttons 51a, 52a in the above embodiment) allows the actuation element 5 to overcome the overtravel limit / first stop 7. In this configuration, the distal end 4a of the balloon 4 does not move on the catheter tip 8 due to the balloon stop 31, but a mechanical load is introduced into the sheath 10, 12.

[0063] In addition, the second stopper 6 can be used with the same principle (see, for example, Figure 6 ) produces a limiter for maximum expansion of the implant 2 (see, for example Fig. 7A ), until a point of no return, which is generally referred to as the "rewrap limit". Until this point / limit, the implant 2 can be rewrap, i.e., the balloon 4 can be fully moved over the partially deployed implant 2 for another deployment attempt or for withdrawal of the implant 2.

[0064] The re-envelopment limit is determined when the inner sheath 12 and the outer sheath 10 are in a defined position relative to each other. The actuating element 5 can be moved on the catheter device handle 13 and defines the relative position between the inner sheath / shaft 12 and the outer sheath / shaft 10. In the event that the actuating element 5 reaches the re-envelopment limit, no further movement / deployment of the implant is possible. In this position, the prosthetic connector 3 is still within the implant capsule 4 and the fastening elements 23 (e.g., eyelets) of the implant are still connected (see FIG. Figure 6 , 7A ) to connector 3.

[0065] like Figure 6 As shown, the second stop 6 can be used to achieve re-wrapping limitation, wherein when the actuator element 5 is in the first state, the second stop 6 is suitable for limiting the movement of the actuator element 5 and the capsule 4, exemplarily in the proximal direction P, thereby preventing the medical implant 2 from being released from the connector 3, and is configured to allow the actuator element 5 to move past the second stop 6 when the actuator element 5 is in the second state, thereby allowing the medical implant 2 to be fully deployed and released from the connector 3.

[0066] In particular, if combined Fig. 7A of Figure 6 As shown, in order to allow partial deployment of the medical implant 2 and optional re-wrapping of the medical implant 2, the capsule 4 includes a portion (e.g., distal portion 4a) configured to cover a fastening element 23 (e.g., an eyelet) of the implant 2 when the actuating element 5 contacts the second stop 6, the fastening element 23 engaging with the recess 30 of the connector 3. In particular, the fastening element 23 can be connected to a stent 20 of the implant 2, which carries an artificial valve 21 (e.g., from biological tissue) including a leaflet 23.

[0067] If the capsule 4 is now completely moved away from the fastening elements 23 arranged in the corresponding recesses 30 of the connector 3, so that the portion 4a of the capsule 4 no longer covers the fastening elements 23, the fastening elements 23 are released and automatically disengage from the recesses 30 of the connector 3, and the medical implant 2 assumes its fully deployed state. Such automatic disengagement can be produced by the self-expansion properties of the medical implant 2 / in particular the stent 2, wherein the fastening elements 23 move away from the connector 3 and disengage from the connector 3 due to the self-expansion properties as soon as the capsule 4 (in particular the portion 4a of the capsule 4) no longer covers the fastening elements 23 and thus no longer holds them in a fixed position relative to the connector 3.

[0068] The complete deployment and release of the implant 2 can be achieved by bringing the actuating element 5 from the first state to the second state, so that its through hole 50 comprises a larger second inner diameter D2, which allows the actuating element 5 to move past the second stop 6, for example in the proximal direction P. Figure 7 shown.

[0069] Figure 8 Details of an embodiment of a catheter device 1 according to the present invention are shown, wherein a first stop 7 and a second stop 6 for providing overtravel limitation and re-wrapping limitation and an actuating element 5 for engaging the stops 6, 7 are arranged on a handle 13 of the catheter device 1, which handle 13 is suitable for moving the balloon 4.

[0070] like Figure 8 As shown, the handle 13 includes a handle core 130 and a rotatable member 131 arranged on the handle core 130, wherein the rotatable member 131 is operably connected to the capsule 4 via the outer sheath 10, so that when the rotatable member 131 rotates along a first rotation direction R1, the capsule 4 exemplarily moves along a proximal direction P and is thereby withdrawn from the medical implant 2, and so that when the rotatable member 131 rotates in an opposite second rotation direction R2, the capsule 4 moves back in a distal direction D to re-cover the medical implant 2.

[0071] In order to engage / pass the stops 6, 7, the actuating element 5 is arranged on the rotatable member 131, wherein the buttons 51a, 52a of the actuating element 5 are accessible via corresponding openings in the rotatable member 131, so that they can be manually pushed to bring the actuating element 5 from the first state to the second state (e.g. against the action of the springs 53, 53). In addition, the handle core 130 extends through the through hole 50 of the actuating element 5.

[0072] Outer sheath 10 Figure 8 Not shown, but connected to the rotatable member 131 (eg via a bearing) at the connection region 90 .

[0073] Furthermore, the handle 13 preferably includes a static grip portion 132 for manually holding the handle 13 , wherein the grip portion 132 is connected to the handle core 130 .

[0074] In particular, the second stop 6 is arranged on the handle core 130 and can be formed as a protrusion of the handle core 130, wherein the actuating element 5 is configured to hit the second stop 6 when the capsule 4 moves exemplarily along the proximal direction P and the actuating element 5 is in a first state (i.e., including a smaller inner diameter D1), and wherein when the capsule 4 moves in the proximal direction P and the actuating element 5 is in the second state (i.e., including a larger inner diameter D2), the actuating element 5 is allowed to move past the second stop 6 in the proximal direction P.

[0075] As previously described, the capsule 4 is operably connected to the rotatable member 131 such that when the actuating element 5 hits the second stop 6 (re-wrapping limit), the implant 2 is in a partially deployed state and can be re-wrapped by rotating the rotatable member 131 along the second rotational direction R2, and such that when the actuating element 5 moves past the second stop 6, exemplarily in the proximal direction P, the medical implant 2 is fully deployed and released from the connector 3.

[0076] Preferably, the first stop member 7 is also arranged on the handle core 130 and can be formed as a protrusion of the handle core 130, wherein the actuating element 5 is configured to hit the second stop member 7 when the capsule 4 moves along the distal direction D exemplarily and the actuating element 5 is in a first state (i.e., including a smaller inner diameter D1), and wherein when the capsule 4 moves along the distal direction D and the actuating element 5 is in a second state (i.e., including a larger inner diameter D2), the actuating element 5 is allowed to move along the distal direction D past the second stop member 7.

[0077] With regard to the overtravel limit 7, the capsule 4 is operatively connected to the rotatable member 131 so that when the actuating element 5 hits the second stop 7, the distal end 4a of the capsule 4 contacts the catheter tip 8 and the capsule 4 completely covers the medical implant 2 (see Figure 2 ), and so that when the actuating element 5 is moved exemplarily in the distal direction D past the second stop 7, the balloon 4 is pressed against the catheter tip 8 and / or the balloon stop 31 (see Figure 5 ).

[0078] In particular, in order to move the capsule 4 using the rotation of the rotatable member 131, the capsule 4 is connected to the rotatable member 131 via the outer sheath / shaft 10 (and the connecting area 90), wherein the rotatable member 131 includes a first internal thread 80 engaged with an external thread 81 formed on the handle core 130, so that when the rotatable member 131 is rotated in the first rotational direction R1, the rotatable member 131 moves together with the capsule 4 in the proximal direction P, and when the rotatable member 131 is rotated in the second rotational direction R2, the rotatable member 131 moves together with the capsule 4 in the distal direction D (see Figure 8 ).

[0079] In order to also move the inner sheath 12, according to Figure 8 and Fig. 9 , the catheter device 1 may include a sliding member 133 to which the inner sheath 12 is connected (e.g. at the proximal connection area 91), wherein the inner sheath 12 is in turn connected to the connector 3 (and therefore to the implant 2 when the implant 2 is still connected to the connector 3).

[0080] The sliding member 133 is arranged in the inner cavity 130a of the handle core 130 and includes an external thread 83, which is configured to engage with the second internal thread 82 of the rotatable member 131, so that when the rotatable member 131 rotates along the first rotation direction R1, the sliding member 133 and the connector 3 connected to the inner sheath / shaft 12 move exemplarily in the distal direction D, and when the rotatable member 131 rotates along the second rotation direction R2, the sliding member 133 and the connector 3 move exemplarily in the proximal direction P.

[0081] In addition, for example Fig. 9 As shown, the projection 9 may be formed by the handle core 130 between the stops 6 , 7 , which is however not mandatory for the function of the stops 6 , 7 , but provides a benefit during manipulation of the rotatable member 131 during surgery.

[0082] In particular, due to said protrusions 9, when the rotatable member 131 of the handle 13 is at the overtravel limit 7, the buttons 51a, 52a of the actuating element 5 are lifted relative to the outer surface of the rotatable member 131. This gives the user / physician the impression that the actuating element 5 can be activated to provide an overtravel travel distance if necessary.

[0083] During deployment, the rotatable member 131 travels on the protrusion 9 of the handle core 130. As the buttons 51a, 52a move on the increased diameter of the protrusion 9, they must expand the inner diameter between the two buttons 51a, 52a. As a result, the height of the buttons 51a, 52a is reduced compared to the surface of the rotatable member. The buttons 51a, 52a are now at the same level of this surface, so activation of the buttons 51a, 52a is impossible (whether consciously or unconsciously).

[0084] When the rotatable member 131 reaches the re-covering limit 6, the buttons 51a, 52a are again located on the smaller outer diameter of the handle core 130. As a result, they reduce the inner diameter of the actuating element 5, and the buttons 51a, 52a are lifted above the outer surface of the rotatable member. This indicates to the user that activation of the buttons 51a, 52a is feasible to overcome the re-covering limit 6 for complete implant / prosthesis release.

[0085] In general, the restrictor functional principles (restrictor mechanisms) disclosed herein can be used with catheters with or without foreshortening compensation.

[0086] In particular, Fig.10 The basic functional principle of the two movable components 51, 52 of the actuating element 5 is shown. Fig.10As shown, the first and second parts 51a, 52b of the movable members 51, 52 facing each other; 52a, 51b preferably include a circular groove 55, which receives the end of the corresponding spring 53, 54 in a form-fitting manner (see, for example Figure 3 ).

[0087] In order to further improve the guidance of the buttons 51a, 52a relative to each other so that they do not tend to separate or tilt when engaging the stoppers 6, 7, each movable member 51, 52 (see Fig.11 and Fig.12 ) comprises flat guide surfaces 61, 62, wherein the flat guide surfaces 61, 62 are configured to slide along each other when the two movable members 51, 52 move from their respective first positions to their respective second positions. Furthermore, according to an embodiment, each of the two movable members 51, 52 comprises a recess 71, 72 into which the guide surface of the other movable member engages. In this way, the recesses 71, 72 prevent the members 51, 52 from separating.

[0088] The present invention provides a significant advantage in that the overtravel limit and / or the rewrap limit are consciously set and the user is thereby aware of potential performance changes and can decide whether to allow further movement of the respective components if desired. Furthermore, the capsule stop avoids an increase in cross-profile or component damage since relative movement is inhibited and stress is introduced only into the sheath.

[0089] From the above disclosure, it will be readily understood by a person skilled in the art that different applications of the subject matter of the invention are conceivable, in particular by suitable catheter configurations, wherein a self-expanding medical implant is released from a catheter comprising an inner shaft and an outer shaft with an implant socket, and the medical implant is anchored / connected to / on the inner shaft, such that it can be recaptured as long as the medical implant is only released to a certain point and is fully released only when a certain point is exceeded.

[0090] For example, where the medical implant is a stent graft or stent graft, where repositionability is advantageous, a corresponding delivery catheter embodying the inventive subject matter would be of value to the skilled artisan.

[0091] Furthermore, the present subject matter may be applicable to the delivery of closed systems such as LAA, PFO, ASD, VSD, etc., or to catheter-based delivery of implantable leadless pacemakers or implantable pressure sensors.

[0092] Thus, in the context of the present invention, the medical implant itself does not necessarily have to be self-expanding, it only requires at least some attachment / connection means between the implant and the corresponding catheter, provided that the implant is released when a certain point is exceeded.

[0093] In view of all the foregoing disclosures, the present invention also relates to the following consecutively numbered embodiments:

[0094] 1. A catheter device (1) for implanting a medical implant (2), comprising:

[0095] - medical implants (2),

[0096] - a connector (3) for holding the medical implant (2),

[0097] a capsule (4) configured to cover the medical implant (2) when the medical implant (2) is arranged on the connector (3) so as to prevent the medical implant from being released from the connector (3), wherein the capsule (4) is movable in a first direction (P) relative to the medical implant (2) for deploying the medical implant (2) and for releasing the medical implant (2) from the connector (3), and wherein the capsule (4) is movable in a second direction (D) for re-covering the medical implant (2) before the medical implant (2) is released from the connector (3)

[0098] It is characterized in that

[0099] The catheter device (1) comprises an actuating element (5) configured to move together with the balloon (4) and to be manually operated to bring the actuating element (5) from a first state to a second state, wherein the catheter device (1) further comprises:

[0100] - a first stopper (7) configured to limit the movement of the actuating element (5) and the capsule (4) in the second direction (D) when the actuating element (5) is in the first state, thereby preventing the capsule (4) from pressing against the catheter tip (8) of the catheter device (1) and / or the capsule stopper (31) of the catheter device (1), and configured to allow the actuating element (5) to move past the first stopper (7) when the actuating element (5) is in the second state, thereby pressing the capsule (4) against the catheter tip (8) and / or the capsule stopper (31);

[0101] and / or

[0102] - a second stopper (6) configured to limit the movement of the actuating element (5) and the capsule (4) in the first direction (P) when the actuating element (5) is in the first state, thereby preventing the medical implant (2) from being released from the connector (3), and configured to allow the actuating element (5) to move past the second stopper (6) when the actuating element (5) is in the second state, thereby allowing the medical implant (2) to be fully deployed and released from the connector (3).

[0103] Throughout the specification, and in the context of the present invention, the first direction may be the proximal direction P, and the second direction may be the opposite direction thereto, ie, the distal direction D, and vice versa.

[0104] Therefore, those skilled in the art will readily appreciate that the first direction is the proximal direction P and the second direction is the distal direction D, which is preferably applicable to the delivery of medical implants, such as artificial aortic heart valves that are not delivered transapically.

[0105] In contrast, those skilled in the art will readily appreciate that the first direction is the distal direction and the second direction is the proximal direction, which is preferably applicable to transapical delivery of medical implants such as artificial aortic heart valves.

[0106] 2. The catheter device according to embodiment 1 is characterized in that the catheter device (1) also includes an outer sheath (10), which extends along the longitudinal axis (x) of the catheter device (1) and surrounds the inner cavity (11) of the outer sheath (10), wherein the distal end of the outer sheath (10) is connected to the bag (4), and wherein the catheter device (1) also includes an inner sheath (12) extending along the longitudinal axis (x), wherein the inner sheath (12) is arranged in the inner cavity (11) of the outer sheath (10) and connected to the connector (3).

[0107] 3. A catheter device according to embodiment 1 or 2, characterized in that the catheter device (1) includes a handle (13) for moving the capsule (4) relative to the medical implant (2), wherein the handle (13) includes a handle core (130) and a rotatable member (131) arranged on the handle core (130), wherein the rotatable member (131) is operably connected to the capsule (4), so that when the rotatable member (131) rotates in a first rotational direction (R1), the capsule (4) moves in a first direction (P) to be extracted from the medical implant (2), and when the rotatable member (131) rotates in a second rotational direction (R2), the capsule (4) moves back in a second direction (D) to re-cover the medical implant (2).

[0108] 4. A catheter device according to one of the aforementioned embodiments, characterized in that the actuating element (5) includes a through hole (50), which has a first diameter (D1) in a first state of the actuating element (5) and a larger second diameter (D2) in a second state of the actuating element (5), wherein the handle core (130) preferably extends through the through hole (50).

[0109] 5. A catheter device according to embodiment 3 or 4, characterized in that a second stopper (6) is arranged on the handle core (130), wherein the actuating element (5) is configured to hit the second stopper (6) when the capsule (4) moves in a first direction (P) and the actuating element (5) is in a first state, and wherein, when the capsule (4) moves in the first direction (P) and the actuating element (5) is in a second state, the actuating element (5) is allowed to move past the second stopper (6) in the first direction (P).

[0110] 6. A catheter device according to one of embodiments 3 to 5, characterized in that the balloon (4) is operably connected to a rotatable member (131) so that when the actuating element (5) hits the second stopper (6), the medical implant (2) is in a partially deployed state, and the medical implant (2) can be re-wrapped by rotating the rotatable member (131) in a second rotational direction (R2), and so that when the actuating element (5) moves in the first direction (6) past the second stopper (6), the medical implant (2) is fully deployed and released from the connector (3).

[0111] 7. A catheter device according to one of embodiments 3 to 6, characterized in that a first stopper (7) is arranged on a handle core (130), wherein the actuating element (5) is configured to hit the first stopper (7) when the capsule (4) moves in a second direction (D) and the actuating element (5) is in a first state, and wherein, when the capsule (4) moves in the second direction (D) and the actuating element (5) is in a second state, the actuating element (5) is allowed to move past the first stopper (7) in the second direction (D).

[0112] 8. A catheter device according to one of embodiments 3 to 7, characterized in that the capsule (4) is operably connected to a rotatable member (131) so that the distal end (4a) of the capsule (4) contacts the catheter tip (8), and when the actuating element (5) hits the first stop (7), the capsule (4) completely covers the medical implant (2), and when the actuating element (5) moves past the first stop (7) in a second direction (D), the capsule (4) is pressed against the catheter tip (8) and / or the capsule stop (31).

[0113] 9. A catheter device according to embodiments 4 to 8, characterized in that the actuating element (5) includes a movable first member (51) including a first opening (510) and a movable second member (52) including a second opening (520), wherein the two movable members (51, 52) are arranged side by side so that the overlapping area of ​​the openings (510, 520) forms a through hole (50) of the actuating element (5), and wherein each of the two movable members (51, 52) is configured to be manually moved from a first position to a second position, wherein when the first and second members (51, 52) are located in the corresponding first positions, the actuating element (5) is in a first state and the through hole (50) includes a first diameter (D1), and wherein when the first and second movable members (51, 52) are located in the corresponding second positions, the actuating element (5) is in a second state and the through hole (50) includes a second diameter (D2).

[0114] 10. A catheter device according to embodiment 9, characterized in that each of the two movable members (51, 52) includes a first part (51a, 52a) and a relative second part (51b, 52b), wherein the corresponding first part (51a, 52a) forms a manually pushable button, and wherein the two movable members (51, 52) are arranged relative to each other so that the first part (51a) of the first movable member (51) faces the second part (52b) of the second movable member (52), and so that the second part (51b) of the first movable member (51) faces the first part (52a) of the second movable member (52).

[0115] 11. A catheter device according to embodiment 10, characterized in that the catheter device (1) includes a first spring (53) arranged between a first part (51a) of a first movable member (51) and a second part (52b) of a second movable member (52), and wherein the catheter device (1) includes a second spring (54) arranged between a first part (52a) of the second movable member (52) and a second part (51b) of the first movable member (51), so that the two first parts (51a, 52a) can be manually pushed toward each other to overcome the restoring force generated by the first and second springs (53, 54) to move each of the two movable members (51, 52) from its first position to its second position.

[0116] 12. A catheter device according to embodiment 11, characterized in that the first part (51a) of the first movable member (51) includes a recess (55) for receiving the first end of the first spring (53), and wherein the second part (52b) of the second movable member (52) includes a recess (55) for receiving the second end of the first spring (53), and wherein the first part (52a) of the second movable member (52) includes a recess (55) for receiving the first end of the second spring (54), and wherein the second part (51b) of the first movable member (51) includes a recess (55) for receiving the second end of the second spring (54).

[0117] 13. A catheter device according to one of embodiments 9 to 12, characterized in that each of the two movable members (51, 52) includes a flat guide surface (61, 62), wherein the flat guide surfaces (61, 62) are configured to slide along each other when the two movable members (51, 52) move from their respective first positions to their respective second positions.

[0118] 14. A catheter device according to one of embodiments 2 to 13, characterized in that the balloon (4) is connected to a rotatable member (131) via an outer sheath (10), wherein the rotatable member (131) includes a first internal thread (80) engaged with an external thread (81) formed on a handle core (130), so that the rotatable member (131) moves in a first direction (P) together with the balloon (4) when rotating in a first rotation direction (R1), and so that the rotatable member (131) moves in a second direction (D) together with the balloon (4) when rotating in a second rotation direction (R2).

[0119] 15. A catheter device according to one of embodiments 2 to 14, characterized in that the catheter device (1) includes a sliding member (133) connected to the connector via an inner sheath (12), wherein the sliding member (133) is arranged in an inner cavity (130a) of the handle core (130) and includes an external thread (83), which is configured to engage with a second internal thread (82) of the rotatable member (131), so that when the rotatable member (131) rotates along a first rotation direction (R1), the sliding member (133) and the connector (3) move along a second direction (D), and when the rotatable member (131) rotates along the second rotation direction (R2), the sliding member (133) and the connector (3) move along the first direction (P).

[0120] 16. The catheter device according to one of embodiments 1 to 15, wherein the first direction is the proximal direction P and the second direction is the distal direction D.

[0121] 17. The catheter device according to one of embodiments 1 to 15, wherein the first direction is the distal direction D and the second direction is the proximal direction P.

Claims

1. A catheter device (1) for implanting a medical implant (2), comprising: - medical implants (2), - a connector (3) for holding the medical implant (2), a capsule (4) configured to cover the medical implant (2) when the medical implant (2) is arranged on the connector (3) so as to prevent the medical implant from being released from the connector (3), wherein the capsule (4) is movable in a first direction (P) relative to the medical implant (2) for deploying the medical implant (2) and for releasing the medical implant (2) from the connector (3), and wherein the capsule (4) is movable in a second direction (D) for re-covering the medical implant (2) before the medical implant (2) is released from the connector (3) It is characterized in that The catheter device (1) comprises an actuating element (5) configured to move together with the balloon (4) and to be manually operated to bring the actuating element (5) from a first state to a second state, wherein the catheter device (1) further comprises: - a first stopper (7) configured to limit the movement of the actuating element (5) and the capsule (4) in the second direction (D) when the actuating element (5) is in the first state, thereby preventing the capsule (4) from being pressed against the catheter tip (8) of the catheter device (1) and / or the capsule stopper (31) of the catheter device (1), and configured to allow the actuating element (5) to move past the first stopper (7) when the actuating element (5) is in the second state, thereby pressing the capsule (4) against the catheter tip (8) and / or the capsule stopper (31); and - a second stopper (6) configured to limit the movement of the actuating element (5) and the capsule (4) in the first direction (P) when the actuating element (5) is in the first state, thereby preventing the medical implant (2) from being released from the connector (3), and configured to allow the actuating element (5) to move past the second stopper (6) when the actuating element (5) is in the second state, thereby allowing the medical implant (2) to be fully deployed and released from the connector (3).

2. The catheter device according to claim 1, characterized in that The catheter device (1) further comprises an outer sheath (10) extending along the longitudinal axis (x) of the catheter device (1) and surrounding an inner cavity (11) of the outer sheath (10), wherein the distal end of the outer sheath (10) is connected to the balloon (4), and wherein the catheter device (1) further comprises an inner sheath (12) extending along the longitudinal axis (x), wherein the inner sheath (12) is arranged in the inner cavity (11) of the outer sheath (10) and connected to the connector (3).

3. The catheter device according to claim 2, characterized in that The catheter device (1) includes a handle (13) for moving the capsule (4) relative to the medical implant (2), wherein the handle (13) includes a handle core (130) and a rotatable member (131) arranged on the handle core (130), wherein the rotatable member (131) is operably connected to the capsule (4), so that when the rotatable member (131) rotates in a first rotation direction (R1), the capsule (4) moves in a first direction (P) to be withdrawn from the medical implant (2), and when the rotatable member (131) rotates in a second rotation direction (R2), the capsule (4) moves back in a second direction (D) to re-cover the medical implant (2).

4. The catheter device according to claim 3, characterized in that The actuating element (5) comprises a through hole (50) having a first diameter (D1) in a first state of the actuating element (5) and a larger second diameter (D2) in a second state of the actuating element (5), wherein the handle core (130) extends through the through hole (50).

5. The catheter device according to claim 3, characterized in that The second stopper (6) is arranged on the handle core (130), wherein the actuating element (5) is configured to hit the second stopper (6) when the capsule (4) moves in the first direction (P) and the actuating element (5) is in the first state, and wherein, when the capsule (4) moves in the first direction (P) and the actuating element (5) is in the second state, the actuating element (5) is allowed to move past the second stopper (6) in the first direction (P).

6. The catheter device according to claim 3, characterized in that The capsule (4) is operably connected to the rotatable member (131) so that when the actuating element (5) hits the second stop (6), the medical implant (2) is in a partially deployed state, and the medical implant (2) can be re-wrapped by rotating the rotatable member (131) in a second rotational direction (R2), and so that when the actuating element (5) moves past the second stop (6) in the first direction (6), the medical implant (2) is fully deployed and released from the connector (3).

7. The catheter device according to claim 3, characterized in that The first stopper (7) is arranged on the handle core (130), wherein the actuating element (5) is configured to hit the first stopper (7) when the capsule (4) moves in the second direction (D) and the actuating element (5) is in the first state, and wherein, when the capsule (4) moves in the second direction (D) and the actuating element (5) is in the second state, the actuating element (5) is allowed to move past the first stopper (7) in the second direction (D).

8. The catheter device according to claim 3, characterized in that The capsule (4) is operably connected to the rotatable member (131) so that the distal end (4a) of the capsule (4) contacts the catheter tip (8) and when the actuating element (5) hits the first stop (7), the capsule (4) completely covers the medical implant (2) and so that when the actuating element (5) moves past the first stop (7) in a second direction (D), the capsule (4) is pressed against the catheter tip (8) and / or the capsule stop (31).

9. The catheter device according to claim 4, characterized in that The actuating element (5) comprises a movable first member (51) comprising a first opening (510) and a movable second member (52) comprising a second opening (520), wherein the two movable members (51, 52) are arranged side by side so that an overlapping area of ​​the openings (510, 520) forms a through hole (50) of the actuating element (5), and wherein each of the two movable members (51, 52) is configured to be manually moved from a first position to a second position, wherein when the first and second members (51, 52) are located in respective first positions, the actuating element (5) is in a first state and the through hole (50) comprises a first diameter (D1), and wherein when the first and second movable members (51, 52) are located in respective second positions, the actuating element (5) is in a second state and the through hole (50) comprises a second diameter (D2).

10. The catheter device according to claim 9, characterized in that Each of the two movable members (51, 52) comprises a first part (51a, 52a) and an opposing second part (51b, 52b), wherein the respective first part (51a, 52a) forms a manually pushable button, and wherein the two movable members (51, 52) are arranged relative to each other so that the first part (51a) of the first movable member (51) faces the second part (52b) of the second movable member (52), and so that the second part (51b) of the first movable member (51) faces the first part (52a) of the second movable member (52).

11. The catheter device according to claim 10, characterized in that The catheter device (1) includes a first spring (53) arranged between a first part (51a) of the first movable member (51) and a second part (52b) of the second movable member (52), and wherein the catheter device (1) includes a second spring (54) arranged between a first part (52a) of the second movable member (52) and a second part (51b) of the first movable member (51), so that the two first parts (51a, 52a) can be manually pushed toward each other to overcome the restoring force generated by the first and second springs (53, 54) to move each of the two movable members (51, 52) from its first position to its second position.

12. The catheter device according to claim 11, characterized in that The first portion (51a) of the first movable member (51) includes a recess (55) for receiving the first end of the first spring (53), and wherein the second portion (52b) of the second movable member (52) includes a recess (55) for receiving the second end of the first spring (53), and wherein the first portion (52a) of the second movable member (52) includes a recess (55) for receiving the first end of the second spring (54), and wherein the second portion (51b) of the first movable member (51) includes a recess (55) for receiving the second end of the second spring (54).

13. The catheter device according to claim 9, characterized in that Each of the two movable members (51, 52) comprises a flat guide surface (61, 62), wherein the flat guide surfaces (61, 62) are configured to slide along each other when the two movable members (51, 52) move from their respective first positions to their respective second positions.

14. The catheter device according to claim 3, characterized in that The capsule (4) is connected to the rotatable member (131) via the outer sheath (10), wherein the rotatable member (131) includes a first internal thread (80) engaged with an external thread (81) formed on the handle core (130), so that the rotatable member (131) moves in a first direction (P) together with the capsule (4) when rotating in a first rotation direction (R1), and moves in a second direction (D) together with the capsule (4) when rotating in a second rotation direction (R2).

15. The catheter device according to any one of claims 3 to 14, characterized in that The catheter device (1) includes a sliding member (133) connected to the connector through the inner sheath (12), wherein the sliding member (133) is arranged in the inner cavity (130a) of the handle core (130) and includes an external thread (83), which is configured to engage with the second internal thread (82) of the rotatable member (131), so that when the rotatable member (131) rotates along the first rotation direction (R1), the sliding member (133) and the connector (3) move along the second direction (D), and when the rotatable member (131) rotates along the second rotation direction (R2), the sliding member (133) and the connector (3) move along the first direction (P).

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