Patent Description:
Such a catheter device usually comprises a capsule for receiving the implant when the latter is in a collapsed state, e.g., a crimped prosthetic heart valve such as a prosthetic aortic heart valve. The capsule covers the implant (e.g. a prosthetic aortic heart valve) that is positioned on a support element connected to an inner sheath of the catheter device while the capsule is connected to an outer sheath (the inner and outer sheaths may also be denoted as inner and outer shafts of the catheter).

Retraction of the outer sheath with respect to the inner sheath allows displacing the capsule with respect to the inner sheath and the support element so as to deploy and release said implant. With the catheter device of the present invention, an implant like a prosthetic aortic heart valve may be, e.g., only partially released and can be retracted into the capsule for the purpose of re-positioning the implant so that it can be deployed at a proper implantation site in a next attempt. Reinserting the implant into the capsule is commonly termed "resheathing" and is for example achievable by providing a connection of the implant to a connector connected to the inner sheath of the catheter device.

Catheter devices of the aforementioned kind, particularly for implantation of a self-expanding transcatheter aortic valve replacement (TAVR) prosthesis (or TAVI prosthesis), are challenging in multiple aspects. A typical drawback is the fact that during recapturing of the TAVI/TAVR implant the catheter is exposed to high axial loads. In challenging anatomies or disadvantageous circumstances, these loads can plastically deform the sheaths of the catheter, which can affect a resheathing of the implant to the extend that the capsule can no longer completely cover the implant. However, the withdrawal of the device from the implantation site/body is only considered safe if the capsule is fully closed, i.e., properly aligned with the catheter tip so that no gap is present between the tip and a distal edge of the capsule.

Typically, safety buttons are known in the prior art which are used to limit the uncovering of the prosthesis. Mechanisms of this kind are for instance described in <CIT>, <CIT>, <CIT>, <CIT>, <CIT> and <CIT>.

<CIT> describes a prosthesis delivery system comprising a handle assembly with a first control mechanism; a second control mechanism; and a decoupling mechanism; and a delivery catheter with an outer shaft controlled by the first control mechanism; and
a prosthesis containing a capsule.

Based on the above, a problem to be solved by the present invention is to provide a catheter device, particularly a TAVI/TAVR catheter device for a self-expanding aortic valve prosthesis, that allows implanting an implant, particularly a prosthetic heart valve, in particular a self-expanding aortic valve prosthesis, with the ability to allow proper closing of the capsule for the purpose of covering the implant during a resheathing procedure even in case of a permanent compression of the outer sheath and/or a permanent elongation of the inner sheath due to axial loads that have acted on the catheter device during implantation of the implant.

This problem is solved by a catheter device having the features of claim <NUM>. Further embodiments are stated in the sub claims and are also described further below.

According to claim <NUM>, a catheter device for implanting a medical implant is disclosed, wherein the catheter device comprises:.

During recapturing of the TAVI/TAVR implant, the catheter is exposed to high axial loads. In challenging anatomies or disadvantageous circumstances, these loads can plastically deform the sheaths of the catheter, particularly said inner and outer sheaths. To ensure that the entire implant can still be covered by the capsule, additional travel of the potentially deformed outer sheath is required. Advantageously, this additional travel can be locked and enabled using the locking element. In addition, the mechanism preferably enables automatic resetting of the locking element after use and it may also provide feedback to the user that the locking element has been deactivated or reactivated.

Advantageously, the invention enables a further movement of the capsule in the distal direction so as to compensate the resulting length mismatch between the outer and inner sheath. With this additional travel, that is also denoted as "overtravel", the outer sheath can be moved further in the distal direction than its original start position.

Furthermore, in the case that the sheaths do not deform in the procedure, the user could potentially close the capsule too far which would result in a sharp edge on the distal end. Therefore, the present invention comprises a locking element so that the overtravel is only available when the locking element is moved to the second state. The activation and deactivation of the compensation feature is thus safe, detectable and reversible.

In the framework of the present invention, the notion "distal" refers to a portion or components of the catheter device that is remote from the handle or from the physician that operates the catheter device while the notion "proximal" refers to those portions or components that are closer to the handle or closer to the physician.

According to a preferred embodiment of the catheter device according to the present invention, the locking element is configured to set a limit to the movement of the traveler in the distal direction such that the capsule completely covers the implant when the traveler has reached this limit and the inner and the outer sheath have not yet been permanently deformed during usage of the catheter and each comprise their initial length in the direction of the longitudinal axis.

According to a further preferred embodiment, in the second state, the locking element is configured to allow further movement of the traveler and therewith of the capsule in the distal direction such that the implant is completely coverable by the capsule despite a permanent compression of the outer sheath or a permanent elongation of the inner sheath. Without the possibility of said further movement (i.e. overtravel) of the capsule, a gap between the catheter tip and the capsule could not be closed properly so that a resheathing procedure could not be successfully completed or would bear the risk of injuring the patient.

Furthermore, according to an embodiment of the present invention, the handle of the catheter device comprises an elongated rod that is slidable along the longitudinal axis, wherein when the locking element is in its first state, the rod is configured to be pressed by the traveler against the locking element to limit the movement of the traveler (and therefore of the capsule) in the distal direction, wherein a first spring element connected to the traveler is arranged between the traveler and the rod and is pretensioned against the rod when the traveler presses against the locking element.

Preferably, the rod comprises a proximal end portion having a concave face side to enclose a front side of the traveler in a form-fitting fashion when the traveler presses against the rod via said face side of the proximal end portion of the rod.

According to a further embodiment, the locking element is configured to release the rod when the locking element is moved from the first state to the second state, wherein the rod is pushed in the distal direction by means of the pretensioned first spring element that is allowed to expand when the locking element sets the rod free in the second state.

Furthermore, according to an embodiment, when the locking element is in the second state, the further movement (so-called overtravel) of the traveler in the distal direction caused by further rotation of the deployment knob in the first rotation direction pushes the rod against a stop provided on the handle which prevents any further movement of the traveler and therewith of the capsule in the distal direction. Now, the first spring element is pretensioned by the traveler against the rod, and a second spring element is pretensioned by the rod against a guiding member of the handle, which guiding member is configured to guide the sliding movement of the rod along the longitudinal axis and also forms said stop for the rod.

According to a further embodiment of the catheter device, the handle comprises an actuating element configured to be manually actuated by a user, wherein the actuating element is operatively connected to the locking element, wherein the locking element is moved from the first state to the second state when the actuating element is actuated by the user. Particularly, the actuating element can be integrally connected to the locking element. Particularly, the actuating element can be a pushable button, wherein actuating the actuating element corresponds to manually pushing the button which causes the locking element to transition from the first state to the second state.

According to yet another embodiment of the catheter device, the handle comprises a third spring element, wherein the third spring element is configured to be pretensioned against the locking element when the latter is moved from the first state to the second state. The third spring element thus provides a restoring force that allows moving the locking element back from the second state to the first state as will be described further below.

According to a further embodiment, the locking element comprises an opening having a narrow portion and an adjacent wider portion, wherein the rod comprises a distal portion comprising a narrow section having a diameter that is smaller than a diameter of an adjacent proximal portion of the rod (that connects to the proximal end portion of the rod) so that the rod forms a step, particularly a circumferential step, at said narrow section, wherein when the locking element is in the first state said narrow section of the rod is arranged in the narrow portion of the opening of the locking element and the rod is configured to be pressed by the traveler against the locking element with said step to prevent the movement of the traveler in the distal direction.

According to a further embodiment, when the locking element is moved from the first state to the second state, the rod becomes arranged in the wider portion of the opening of the locking element so that the step of the rod is allowed to move through the wider portion of the opening of the rod by the action of the pretensioned first spring element when the latter expands.

The deactivated locking element that allows movement of the rod in the distal direction in the second state can be automatically transferred back into the first state using the pretensioned third spring element when the capsule is opened again, i.e. by moving the outer sheath via the traveler in the proximal direction.

Particularly, when the traveler pushes the rod against the stop (which means that the maximal overtravel of the capsule has been realized) or when the second spring element is pretensioned, moving the traveler and therewith the capsule in the proximal direction (to again deploy the implant) causes the pretensioned second spring element to move the rod in the proximal direction, too, such that said narrow section of the rod moves back into the opening of the locking element at a certain position of the traveler which allows the third spring element to move the locking element back into the first state in which said section of the rod is in turn arranged in the narrow portion of the opening of the locking element.

The locking element has now returned to the first state and will limit further movement of the capsule in the distal direction until it is again moved to the second state by manually actuating, e.g. pushing, the actuating element (e.g. pushable button).

According to a further embodiment of the present invention, the deployment knob is rotatably supported on the guiding member of the handle that forms the stop for the rod and is also configured to guide the movement of the rod along the longitudinal axis.

In the following, further features and advantages of the present invention are described in detail with reference to the Figures which show preferred embodiments of the catheter device according to the present invention, wherein.

The present invention enables further travel of a capsule <NUM> of a catheter device <NUM> so that the capsule <NUM> can properly resheath a partially deployed implant <NUM> even in case an outer and inner sheath <NUM>, <NUM> of the catheter device <NUM> have been permanently deformed due to axial loads during the implantation procedure.

The principle mechanism of the invention is illustrated in <FIG> and will be explained below in context with functions of the handle <NUM> and other components of the catheter device <NUM>.

Particularly, <FIG> shows a distal portion of an embodiment of a catheter device <NUM> according to the present invention, which comprises a handle <NUM> that can be used to control functions of the catheter device <NUM>. The handle is e.g. illustrated in <FIG> and will be described in more detail further below. The catheter device <NUM> is configured to position a medical implant <NUM>, particularly a prosthetic heart valve prosthesis such as a prosthetic aortic heart valve at an implantation site (e.g. anulus of a native aortic valve that is to be replaced). As indicated in <FIG>, the implant <NUM> can comprise a self-expanding stent <NUM> with a tissue-based valve that can comprise three valve leaflets connected to the stent <NUM>. <FIG> shows the stent <NUM> in a crimped state, wherein the leaflets (not shown in <FIG>) can be made out of a biological tissue. The stent <NUM> preferably comprises a plurality of interconnected struts <NUM>, so that the stent <NUM> forms a circumferential scaffold comprising a plurality of lateral openings. The catheter device <NUM> can facilitate prosthesis delivery as well as axial positioning and angular orienting. Furthermore, the handle <NUM> can enable partial deployment, full deployment and recapturing (resheathing) of the medical implant / prosthetic heart valve <NUM>.

Particularly, the handle <NUM> can be adapted to manipulate, particularly steer, four sheaths <NUM>, <NUM>, <NUM>, and <NUM> as shown in <FIG>, namely: an inner sheath <NUM> (also denoted as inner shaft <NUM>) enclosing a guidewire lumen <NUM>, a deflection sheath <NUM> (also denoted as deflection shaft <NUM>) enclosing the inner sheath <NUM>, an outer sheath <NUM> (also denoted as outer shaft <NUM>) enclosing the inner sheath <NUM> and the deflection sheath <NUM>, as well as a stabilizing sheath <NUM> (also denoted as stabilizing shaft or short "stabilizer" <NUM>) enclosing a proximal section of the inner sheath <NUM>, deflection sheath <NUM> and outer sheath <NUM>. Particularly, each sheath <NUM>, <NUM>, <NUM> forms a tubular member.

As indicated in <FIG>, the deflection sheath <NUM> can be deflected with a pulling member such as a pull wire <NUM> (for example a stainless-steel wire) that can be connected to a distal end section 60a of the deflection sheath <NUM>. The pull wire <NUM> is arranged in a lumen of the deflection sheath <NUM>. The deflection sheath <NUM> can comprise lateral openings so that the deflection sheath can be deflected by tensioning the pull wire <NUM>. Particularly, in this way, the deflection sheath <NUM> can be deflected beyond <NUM>°. In the letter case, the deflection sheath comprises a u-shaped distal end section 60a.

The inner and the outer sheath <NUM>, <NUM> can be moved relative to the deflection sheath <NUM> (and relative to the stabilizing sheath <NUM>). Additionally, the outer sheath <NUM> can be moved relative to the inner sheath <NUM>. The stabilizing sheath <NUM> is stationary and fixed to a grip portion <NUM> of the handle <NUM> (cf. The stabilizing sheath <NUM> does only bridge the movements of the other sheaths <NUM>, <NUM>, <NUM> to the anatomy of the patient and/or an introducer, if necessary. Particularly, the deflection sheath <NUM> is shorter than the inner and the outer sheath <NUM>, <NUM>. Further, a capsule <NUM> can be connected to a distal end 10a of the outer sheath <NUM> (e.g. via a capsule connector <NUM>, cf. <FIG>), wherein the capsule <NUM> can be larger in diameter (perpendicular to the longitudinal axis x along which the sheaths <NUM>, <NUM>, <NUM>, <NUM> extend) than a proximal section of the outer sheath <NUM>.

For delivery using the catheter device <NUM>, the medical implant <NUM>, here an aortic prosthetic heart valve <NUM>, is placed on a support element <NUM> that is connected to a distal end section 20a of the inner sheath <NUM> and covered by the capsule <NUM>. The support element <NUM> can be connected to the inner sheath <NUM> via a connector <NUM> to which the heart valve prosthesis <NUM> is releasably connectable for delivery to an implantation site when it is arranged in the capsule <NUM>. The guidewire lumen <NUM> can be formed by a tubing <NUM> that protrudes out of the inner sheath <NUM> at the distal end 20a of the inner sheath <NUM>, extends through the connector <NUM> and support element <NUM>, and connects to a catheter tip <NUM> to which the tubing <NUM> is connected. Furthermore, the catheter tip <NUM> can comprise an opening <NUM> formed in a distal end 24a of the catheter tip <NUM>, so that the guidewire can exit the guidewire lumen <NUM> via said opening <NUM> (cf. <FIG> and <FIG>).

The movements and functions of the catheter device <NUM> can be realized with the handle <NUM> of the catheter device <NUM> (cf. <FIG>), to this end, the handle <NUM> can comprise:.

The handle <NUM> can further comprise actuating means for achieving a simultaneous movement of the inner and outer sheath <NUM>, <NUM> as well as for deflecting the sheaths <NUM>, <NUM> using the deflection sheath <NUM> and pull wire <NUM>.

Preferably, the knob <NUM> is rotatable about the longitudinal axis x of the catheter device <NUM>, along which axis x the handle <NUM> extends.

Furthermore, the grip portion <NUM> comprises an opening 71c at a distal end 71a of the grip portion <NUM> through which all sheaths <NUM>, <NUM>, <NUM>, <NUM> extend into the handle <NUM> at the distal end 71a of the grip portion <NUM> (the sheaths are not shown in <FIG>).

For deflecting the deflection sheath <NUM>, an actuating means such as a deflection knob can be provided on the handle <NUM> that can be operatively connected to a distal end section 60a of the deflection sheath <NUM> via the pull wire <NUM>, so that the deflection sheath <NUM> and thereby the inner and the outer sheath <NUM>, <NUM> are deflected, i.e. bent, to adjust an angular orientation of the medical implant <NUM> when the deflection knob is rotated about the longitudinal axis x which causes tensioning or loosening of the pull wire <NUM> depending on the direction of the rotation.

Further, for moving the inner and the outer sheath <NUM>, <NUM> simultaneously, the handle <NUM> can comprise a guiding member (also denoted as handle core) <NUM> (cf. <FIG>) that is movable with respect to the grip portion <NUM> along the longitudinal axis x, wherein the inner and the outer sheath <NUM>, <NUM> are connected to the guiding member <NUM>, and an actuating means such as an axial positioning knob can be operatively connected to the guiding member <NUM> such that the inner and the outer sheath <NUM>, <NUM> are simultaneously moved with the guiding member <NUM> with respect to the grip portion <NUM> (and with respect to the deflection sheath <NUM> and stabilizing sheath <NUM>) along the longitudinal axis x when the axial positioning knob is rotated about the longitudinal axis x.

Further, the handle <NUM> comprises a traveler <NUM> (also denoted as outer sheath hub), wherein the outer sheath <NUM> is connected to the traveler <NUM>, and wherein the deployment knob <NUM> is operatively connected to the traveler <NUM> such that the traveler <NUM> and thereby the outer sheath <NUM> are moved along the longitudinal axis x with respect to the inner sheath <NUM>, and so as to deploy the medical implant <NUM> when the deployment knob <NUM> is rotated in a first rotation direction of the deployment knob <NUM> (cf.

If the physician is satisfied with the positioning of the catheter device <NUM>, deployment of the prosthesis <NUM> is started by the physician. In this regard, an axial movement of the outer sheath <NUM> (and therewith of the capsule <NUM> and implant <NUM>) in the proximal direction P relative to all other sheaths <NUM>, <NUM>, <NUM> and the grip portion <NUM> of handle <NUM> releases the implant <NUM>; e.g. a prosthetic aortic heart valve. This movement of the outer sheath <NUM> can be controlled by means of the deployment knob <NUM> (cf. <FIG>), wherein rotation of the deployment knob <NUM> moves the traveler <NUM> to which the outer sheath <NUM> is connected. The movement of the outer sheath <NUM> and therewith of the capsule <NUM> in the proximal direction P releases the implant <NUM>.

For releasing the implant <NUM> based on the above-described movement of the outer sheath <NUM> and capsule <NUM>, the connector <NUM> connected to a distal end 20a of the inner sheath <NUM> can comprise a recess <NUM>, wherein the at least one fastening element <NUM> of the medical implant <NUM> is engaged with the at least one recess <NUM> as long as the capsule <NUM> covers the at least one recess <NUM> of the connector <NUM> and the at least one fastening element <NUM> that engages with the at least one recess <NUM> when the prosthetic heart valve <NUM> is arranged on the support <NUM> (cf. The at least one fastening element <NUM> can be formed by a portion of the self-expandable stent <NUM> of the prosthetic heart valve <NUM>. Particularly, as shown in <FIG>, the at least one fastening element <NUM> can be connected to at least one strut <NUM> of the stent <NUM> at a proximal end of the stent <NUM>. For example, the stent <NUM> can comprise three such fastening elements <NUM>. In this case, the connector <NUM> comprises three corresponding recesses <NUM>.

Once the capsule <NUM> is completely removed from the implant <NUM> and does no longer cover the at least one fastening element <NUM> and the corresponding recess <NUM> of the connector <NUM> (cf. lower part of <FIG>) the at least one fastening element <NUM> disengages with the connector <NUM> due to the self-expanding property of the implant <NUM> / stent <NUM>, which releases the implant <NUM> at the implantation site. After complete deployment and release of the implant <NUM> from the catheter device <NUM>, resheathing of the implant <NUM> is no longer possible.

In case the implant <NUM> is only partially deployed and still connected to the connector <NUM>, resheathing of the implant <NUM> is possible. However, due to high axial loads acting on the inner and outer sheath <NUM>, <NUM> during the implantation procedure, the sheaths <NUM>, <NUM> can become permanently deformed in the direction of the longitudinal axis x during operation of the catheter device <NUM>. This usually corresponds to a compression of the outer sheath <NUM> and an elongation of the inner sheath <NUM>; which means that it is no longer possible to properly close the capsule <NUM>, i.e., to completely cover the implant <NUM> with the capsule <NUM>. Typically, a gap can result between the tip <NUM> and a distal edge of the capsule <NUM> which means that the resheathing cannot be properly completed.

In order to prevent this outcome, the present invention provides the capsule <NUM> with an additional travel which is denoted as overtravel and corresponds to a further movement of the capsule <NUM> in the distal direction D past the initial limit of the capsule <NUM>.

As shown in <FIG>, in order to achieve this additional travel, the movement of the outer sheath <NUM> and therewith of the capsule <NUM> is coupled via e.g. the traveler <NUM> to an elongated rod <NUM> of the handle <NUM>.

With the axial movement in the distal direction D during closing of the capsule <NUM>, the rod <NUM> is reaching a rigid barrier in form of a locking element <NUM> which is inhibiting further axial travel of the rod <NUM> and therewith of the traveler <NUM> in the distal direction D. A first spring element <NUM> between the traveler <NUM> and the rod <NUM> is loaded in this position (cf.

The locking element <NUM> can be configured to allow passage of the rod <NUM> through an opening <NUM> and can be configured to comprise a push button <NUM> for moving the locking element <NUM> perpendicular to the longitudinal axis x/ distal direction D. The pushing of the locking element <NUM> loads the third spring element <NUM>. Once the barrier <NUM> is removed, the rod <NUM> is pushed forward by the pretensioned first spring element <NUM>. According to an embodiment of the present invention, the unloading of the first spring element <NUM> is audible and the change in position of the push button <NUM> is visible (cf.

Subsequently, the user can move the traveler <NUM> and therewith the outer sheath <NUM> and capsule <NUM> forward in the distal direction D and the rod <NUM> moves further through the opening <NUM> of the locking element/barrier <NUM>. Using this overtravel, the user carefully closes the capsule <NUM> (capsule <NUM> properly aligned with the atraumatic tip <NUM> in a gapless fashion) and thereby pretensions the first spring element <NUM> as well as the second spring element <NUM> (cf.

In the next step, in case the user is satisfied with the repositioned implant, the user is releasing the implant <NUM> again. The outer sheath <NUM> is moved in the opposite direction (proximal direction P) and the implant <NUM> is deployed. After this second deployment it is possible that the user needs to resheath the prosthesis again. Therefore, the already used locking mechanism must be re-activated.

This lock reactivation is achieved by means of the second and third spring element <NUM>, <NUM>. Starting from <FIG>, the traveler <NUM> that connects to the outer sheath <NUM> and capsule <NUM> is now being moved in the proximal direction P (i.e. to the left). This allows the second spring element <NUM> to force the rod <NUM> to follow the traveler <NUM>. Once the rod <NUM> has traveled past the locking element / barrier <NUM>, the third spring element <NUM> pushes the locking element / barrier <NUM> back into the locked position (first state). According to an embodiment, the relaxation of the third spring element <NUM> is audible and the position change of the locking element / barrier <NUM> is visible via the push button <NUM>. With this mechanism, the lock/unlock cycle can be repeated.

This mechanism can be integrated in various ways into a handle <NUM> of a catheter device <NUM>. In the following an embodiment of such an integration is described with reference to <FIG>.

As shown in <FIG> in conjunction with <FIG> and <FIG>, the catheter device <NUM> comprises an outer sheath <NUM> extending along a longitudinal axis x of the catheter device <NUM> and surrounding a lumen <NUM> of the outer sheath <NUM>, an inner sheath <NUM> extending along the longitudinal axis x, wherein the inner sheath <NUM> is arranged in the lumen <NUM> of the outer sheath <NUM> and connected to a support element <NUM> for supporting the medical implant <NUM>, a capsule <NUM> connected to a distal end 10a of the outer sheath <NUM> for covering the medical implant <NUM> when the medical implant <NUM> is arranged on the support element <NUM>, a handle <NUM> comprising: a grip portion <NUM> for manually holding the handle <NUM>, a rotatable deployment knob <NUM>, and a traveler <NUM>, wherein the outer sheath <NUM> (cf. <FIG>, not shown in <FIG>) is connected to the traveler <NUM>, wherein the deployment knob <NUM> comprises a helical groove <NUM> formed in an inside <NUM> of the deployment knob <NUM>, wherein the traveler <NUM> engages into the helical groove <NUM> of the deployment knob <NUM> such that the traveler <NUM> and thereby the outer sheath <NUM> are moved in a proximal direction P along the longitudinal axis x with respect to the inner sheath <NUM> when the deployment knob <NUM> is rotated in a first rotation direction R1, so that the capsule <NUM> is pulled away from the medical implant <NUM> in the proximal direction P to deploy the medical implant <NUM>, and such that the traveler <NUM> and thereby the outer sheath <NUM> are moved in the distal direction D along the longitudinal axis x with respect to the inner sheath <NUM> when the deployment knob <NUM> is rotated in an opposite second rotation direction R2 (cf. <FIG>), so that the capsule <NUM> is moved over the medical implant <NUM> to cover the medical implant <NUM>. Furthermore, the handle <NUM> comprises a locking element <NUM> that is configured to be moved from a first to a second state, wherein the locking element <NUM> limits a movement of the traveler <NUM> and therewith of the capsule <NUM> in the distal direction D in the first state, and wherein the locking element <NUM> allows further movement of the traveler <NUM> and therewith of the capsule <NUM> in the distal direction D in the second state. Particularly, the inner sheath (cf. <FIG>, not shown in <FIG>) is stationary during the deploy/resheath cycle which can include an unlock/lock cycle.

As stated above, the deploy traveler <NUM> is connected to the outer sheath <NUM> and is moved in axial direction x by the rotation of the deployment knob <NUM>. On the front side 76a of the traveler <NUM>, a first spring element <NUM> is connected to the traveler <NUM> that protrudes from the front side 76a in the distal direction D and moves with the traveler <NUM> (cf.

Particularly, the traveler <NUM> moves in the distal direction D (to the right) until it reaches an elongated slidable rod <NUM> that is also denoted as overtravel traveler. The state depicted in <FIG> and <FIG> essentially corresponds to the state shown in <FIG>.

When the traveler <NUM> has reached the rod <NUM> as shown in <FIG>, the front side 76a is particularly enclosed in a form-fitting manner by a concave face side of a proximal end portion 81a of the rod <NUM>. The first spring element <NUM> is therefore fully loaded, i.e., pretensioned against the rod <NUM>. The second spring element <NUM> that surrounds the rod <NUM> is not yet loaded since the rod <NUM> is stopped by the locking element <NUM> as shown in <FIG>.

<FIG> shows a side (left) and a front (right) view of the lock mechanism. The rod <NUM> is pushed in the distal direction D by the traveler <NUM>/first spring element <NUM> (not visible in <FIG>). The locking element <NUM> is blocking the path of the rod <NUM>, wherein a third spring element <NUM> below the locking element <NUM> is holding the locking element <NUM> in the default first state corresponding to the locked state of the locking element <NUM>.

Particularly, the locking element <NUM> comprises an opening <NUM> having a narrow portion 802a and an adjacent wider portion 802b. Correspondingly, the rod <NUM> comprises a distal portion comprising a narrow section 81b having a diameter that is smaller than a diameter of an adjacent proximal portion of the rod <NUM> so that the rod <NUM> forms a step 81c (e.g. a circumferential step) at said section 81b, wherein when the locking element <NUM> is in the first (locked) state said narrow section 81b of the rod <NUM> is arranged in the narrow portion 802a of the opening <NUM> and the rod <NUM> cannot be moved further through the opening <NUM> since the step 81c butts against the locking element <NUM>, namely against an edge of the narrow portion 802a of the opening <NUM>.

According to <FIG>, the additional travel of the traveler <NUM> / capsule <NUM> is activated by pushing down a top side <NUM> of the locking element <NUM> which forms a push button <NUM>. The corresponding downward movement of the locking element <NUM> arranges the rod <NUM> in the wider portion 802b of the opening <NUM> which clears the path for the rod <NUM> to travel through, since the wider portion 802b comprises a diameter that does not allow blocking of the step 81c of the rod <NUM>.

Now, with the locking element <NUM> being in the second (open) state, the traveler's <NUM> first spring element <NUM> pushes the rod <NUM> forward through the opening <NUM> of the locking element <NUM>. Particularly, the user can hear/feel the jump of the rod <NUM> as feedback for successful unlocking. Due to the button <NUM>/locking element <NUM> being pushed into the second state, the third spring element <NUM> is now loaded.

The elongated rod <NUM> can now travel freely through the wider portion 802b of the opening <NUM> of the locking element <NUM>. The distal movement of the deploy traveler <NUM> (overtravel) can be used by rotating the deployment knob <NUM> further in the first rotation direction R1 until the first spring element <NUM> and the second spring element <NUM> are fully compressed or the rod <NUM> hits a stop <NUM> provided on the handle <NUM>.

Particularly, the locking element <NUM> being in the second (unlocked) state allows a specific extra overtravel. According to an embodiment, this overtravel is in the range from <NUM> to <NUM>. Particularly, the overtravel amounts to <NUM> in an embodiment. <FIG> shows the maximum overtravel/possible further movement of the capsule <NUM>. In this case the first and the second spring element <NUM>, <NUM> are fully compressed and the rod <NUM> reaches the stop <NUM>.

Particularly, as shown in <FIG>, the rod <NUM> is guided by a guiding member <NUM> that is also denoted as handle core <NUM>. The guiding member <NUM> comprises an elongated hole <NUM> into which the rod <NUM> extends and which guides the rod <NUM> upon its movement long the longitudinal axis x. A bottom <NUM> of the hole <NUM> forms the hard stop for the rod <NUM>. The second spring element <NUM> that surrounds the rod <NUM> butts with a first end 810a against a circumferential step <NUM> formed on an internal surface of the hole <NUM>, and with a second end 810b against the proximal end portion 81a of the rod <NUM>. In this way, the pretensioned second spring element <NUM> can push the rod <NUM> in the proximal direction P in case the traveler <NUM> is moved back in the proximal direction P with the locking element <NUM> being in the second (open) state.

After successful recapturing of the implant <NUM> with the help of the overtravel of the capsule <NUM>, the user opens the capsule <NUM> (i.e. moves it proximal) for a second deploy attempt. The deploy traveler <NUM> then moves in the proximal direction (to the left in <FIG>) and the second spring element <NUM> ensures that the entire rod <NUM> is moving proximal, too. If the traveler <NUM> reaches the initial position before the overtravel activation, the narrow section 81b of the rod <NUM> is aligned with the opening <NUM> of the locking element <NUM> again. The third spring element <NUM> can thus push the locking element <NUM> back up in its original position (first state). This means that the narrow section 81b of the rod shifts to the narrow portion 802a of the opening <NUM> of the locking element <NUM> such that the rod <NUM> presses with its step 81c against the locking member <NUM> in case an attempt to move the traveler <NUM> further distal is made. The locking element / mechanism <NUM> can now be reused.

Particularly, the movement of the locking element <NUM> is visible as well as audible.

Claim 1:
A catheter device (<NUM>) for implanting a medical implant (<NUM>), comprising:
- an outer sheath (<NUM>) extending along a longitudinal axis (x) of the catheter device (<NUM>) and surrounding a lumen (<NUM>) of the outer sheath (<NUM>),
- an inner sheath (<NUM>) extending along the longitudinal axis (x), wherein the inner sheath (<NUM>) is arranged in the lumen (<NUM>) of the outer sheath (<NUM>) and connected to a support element (<NUM>) for supporting the medical implant (<NUM>) or to a connector (<NUM>),
- a capsule (<NUM>) connected to a distal end (10a) of the outer sheath (<NUM>) for covering the medical implant (<NUM>) when the medical implant (<NUM>) is arranged on the support element (<NUM>) or the connector (<NUM>),
- a handle (<NUM>) comprising: a grip portion (<NUM>) for manually holding the handle (<NUM>), a rotatable deployment knob (<NUM>), and a traveler (<NUM>), wherein the outer sheath (<NUM>) is connected to the traveler (<NUM>), wherein the deployment knob (<NUM>) comprises a helical groove (<NUM>) formed in an inside (<NUM>) of the deployment knob (<NUM>), wherein the traveler (<NUM>) engages into the helical groove (<NUM>) of the deployment knob (<NUM>) such that the traveler (<NUM>) and thereby the outer sheath (<NUM>) are moved in a proximal direction (P) along the longitudinal axis (x) with respect to the inner sheath (<NUM>) when the deployment knob (<NUM>) is rotated in a first rotation direction (R1), so that the capsule (<NUM>) is pulled away from the medical implant (<NUM>) in the proximal direction (P) to deploy the medical implant (<NUM>), and such that the traveler (<NUM>) and thereby the outer sheath (<NUM>) are moved in the distal direction (D) along the longitudinal axis (x) with respect to the inner sheath (<NUM>) when the deployment knob (<NUM>) is rotated in an opposite second rotation direction (R2), so that the capsule (<NUM>) is moved over the medical implant (<NUM>) to cover the medical implant (<NUM>), wherein the handle (<NUM>) comprises a locking element (<NUM>) that is configured to be moved from a first to a second state, wherein the locking element (<NUM>) limits a movement of the traveler (<NUM>) and therewith of the capsule (<NUM>) in the distal direction (D) in the first state, and wherein the locking element (<NUM>) allows a further movement of the traveler (<NUM>) and therewith of the capsule (<NUM>) in the distal direction (D) in the second state.