Insertion catheter system for inserting and positioning a radially compressed heart valve stent into the body of a patient and for placing the heart valve stent in an implantation location in the heart of the patient
The delivery catheter system enables precise, minimally invasive implantation of heart valve prostheses with sequential stent arch release, addressing complex implantation and mispositioning issues, ensuring correct placement and reducing surgical risks.
Patent Information
- Authority / Receiving Office
- WO · WO
- Patent Type
- Applications
- Current Assignee / Owner
- DEVIE MEDICAL GMBH
- Filing Date
- 2025-12-18
- Publication Date
- 2026-07-02
AI Technical Summary
Existing medical devices for transvascular implantation of heart valve prostheses with self-expanding stents face challenges such as complex and time-consuming implantation procedures, incorrect positioning, difficulty in correcting mispositioning without major surgery, and the risk of irreversible anchoring stent placement, especially in the aortic arch, which requires a 180° change with a small radius.
A delivery catheter system with a handle that allows sequential release of anchoring/compartmenting/positioning arches of the stent from cranial to caudal, reducing the catheter's circumference and enabling precise placement of the stent at the implantation site, even in the ascending aorta, using a catheter system with a handle that controls the release sequence.
Facilitates predictable, minimally invasive implantation of heart valve prostheses with reduced risk of mispositioning and irreversible anchoring, allowing for correction without major surgery, and accommodating various heart valve conditions, including low or no calcification and infected valves.
Smart Images
Figure EP2025088000_02072026_PF_FP_ABST
Abstract
Description
[0001] December 18, 2025 devie medical GmbH A / FIG-025-PC TR
[0002] INTRODUCTION CATHETTER SYSTEM FOR INTRODUCING AND POSITIONING A RADIALLY COMPRESSED CARDIOLATING TENTS INTO THE BODY OF A PATIENT AND FOR PLACING THE CARDIOLATING TENTS IN AN IMPLANTATION SITE IN THE HEART OF THE PATIENT
[0003] Description
[0004] The present invention relates to an insertion catheter system for inserting and positioning a stent, in particular a self-expanding stent, especially a heart valve stent, into the body of a patient and for placing the stent in a desired implantation site, in particular in the heart of the patient.
[0005] The invention further relates to a medical device for the treatment of heart valve stenosis and / or heart valve insufficiency, in particular aortic valve insufficiency in a patient, wherein the medical device comprises the aforementioned delivery catheter system and a stent, in particular a self-expanding stent, which is received or can be received in a catheter tip of the delivery catheter system.
[0006] The invention further relates to a medical device for treating inflammation of the inner lining of the heart (endocarditis), in particular bacterial endocarditis, in a patient, wherein the medical device comprises the aforementioned delivery catheter system and a stent, in particular a self-expanding stent, which is received or can be received in a catheter tip of the delivery catheter system.
[0007] In medical technology, efforts have long been underway to treat heart valve insufficiency, such as aortic valve insufficiency (i.e., inadequate closure of the aortic valve and the resulting backflow of blood from the aorta into the left ventricle), non-surgically—that is, without surgery in the true sense—using a catheter-based implant via a transaortic interventional approach. Various delivery systems and stent systems, including the MEISSNER BOLTE A / FIG-025-PC 2, have been used in this context.
[0008] Various advantages and disadvantages have been proposed, some of which can also be introduced transarterially into a patient's body via a catheter insertion system.
[0009] In all transcatheter implantable heart valve systems, a self-expanding or balloon-expandable stent system is inserted transvenously or transarterially to the heart valve being treated. Such a stent system consists, for example, of a self-expanding anchoring stator to which the actual heart valve prosthesis is attached, preferably at the proximal retention area of the anchoring stator.
[0010] However, with existing medical devices known from the prior art, a disadvantage is that the implantation procedure of the stent system with the attached heart valve prosthesis is relatively complicated, difficult, and time-consuming. Apart from the complex implantation of the heart valve prosthesis into the insufficient native heart valve, the medical devices used inherently carry the risk of incorrect positioning, which cannot be corrected without a major surgical procedure.
[0011] In medical technology, there is a need for a delivery system for the transvascular implantation of a heart valve prosthesis with a self-expanding stent. This delivery system should allow for a predictable, minimally invasive implantation of the heart valve prosthesis and eliminate the need for a heart-lung machine during the procedure. This would make the surgical intervention particularly cost-effective and, more importantly, reduce the patient's physical and psychological stress. In particular, medical devices for the implantation of heart valve prostheses are needed that can also be used in patients who, for example, cannot undergo surgery with the aid of a heart-lung machine due to illness or age.
[0012] This also applies to operations in which heart valve prostheses with stent systems are implanted using so-called balloon catheter systems. MEISSNER BOLTE A / FIG-025-PC 3
[0013] In this context, it is also problematic that with the systems already known from the state of the art, with which a heart valve prosthesis can be implanted in the patient's body in a minimally invasive manner, mispositioning of the heart valve prosthesis or the associated anchoring stent can often only be avoided by a particularly experienced doctor.
[0014] While it is known to insert an anchoring stent with an attached heart valve prosthesis into a patient's body via the aorta to the heart, whereby upon reaching the implantation site in or on the heart, self-expansion of the anchoring stent is initiated by external manipulation, which should lead to secure fixation and exact positioning of the heart valve prosthesis, such anchoring stents are generally no longer easily explantable or correctable in terms of their position after their expansion.
[0015] Accordingly, with the known systems there is a fundamental risk that if, for example, due to a mistake by the treating physician or due to other circumstances, the self-expansion of the anchoring stent with the attached heart valve prosthesis is initiated in a non-optimal position, this position can only be corrected accordingly by means of a major, especially surgical, intervention, which often has to be performed on the open heart.
[0016] Through this expansion, the anchoring stent stretches so that it can adhere to the aortic wall in the area of the native, diseased valve and, if necessary, be securely fixed there using additional structures. Simultaneously, the heart valve prosthesis unfolds at the proximal end of the anchoring stent, allowing it to take over the function of the native (insufficient) heart valve.
[0017] Such an anchoring stent with a heart valve prosthesis is described, for example, in publication WO 2004 / 019825 Al.
[0018] With this type of anchoring stent, support brackets are located on the proximal side.
[0019] Positioning brackets designed to be inserted into pockets of a patient's native heart valve, allowing the anchoring stent to be positioned using these MEISSNER BOLTE A / FIG-025-PC 4
[0020] Support brackets can be positioned. The known anchoring stent also incorporates so-called commissural brackets, which, together with the support brackets, clamp parts of the old heart valve after the anchoring stent has deployed, so that the anchoring stent can be positioned and fixed as a result of this clamping effect.
[0021] Although the support brackets formed on the anchoring stent can improve the positioning of the heart valve prosthesis to be implanted, the risk of implantation failure and unsatisfactory or non-functionality of the heart valve prosthesis remains. For example, it may become apparent during the procedure that the dimensions of the heart valve prosthesis or the anchoring stent are not optimal for the patient. Even if, in such a case, the respective proximal support brackets are first attached to the anchoring stent, the prosthesis may still not function correctly.
[0022] If the positioning stent is in its expanded state, removal (explantation) or repositioning of the anchoring stent with the heart valve prosthesis is no longer possible, or there is an increased risk of mortality for the respective patient.
[0023] Another problem with such procedures is the aortic arch in the human body, which must be penetrated during insertion via the aorta. This requires a change of direction of approximately 180° with a relatively small radius of about 50 mm when moving the catheter tip and the catheter itself, without damaging the vessel wall.
[0024] An introduction catheter system for introducing a self-expanding heart valve stent into the body of a patient and for placing the heart valve stent in a desired implantation site in the patient's heart is known, for example, from publication WO 2008 / 138584 Al.
[0025] This state of the art also relates to a corresponding medical device for the treatment of heart valve stenosis and / or heart valve insufficiency, in particular aortic valve insufficiency in a patient.
[0026] The provision is that the heart valve stent, which is inserted into the catheter tip of the delivery catheter system, is located in the catheter tip of the MEISSNER BOLTE A / FIG-025-PC 5
[0027] The heart valve stent, once inserted into the delivery catheter system, has an initial (compressed) shape and an expanded shape outside the catheter tip or in the implanted state. Upon release of the heart valve stent from the catheter tip of the delivery catheter system known from the prior art, the anchoring / positioning arches of the heart valve stent are released first. These released anchoring / positioning arches engage in the leaflets of the native heart valve to position the heart valve stent at the implantation site. Subsequently, the main body of the heart valve stent, and in particular its retention arches or retaining clips, are released from the catheter tip.
[0028] The system known, for example, from WO 2008 / 138584 Al has several disadvantages. Firstly, the heart valve stent known from WO 2008 / 138584 Al has a relatively large cross-section in its compressed state, because the heart valve stent has various functional components, in particular the aforementioned anchoring / positioning arches and the retention arches.
[0029] In cases of aortic valve insufficiency and / or an infected heart valve, a secure and orthotopic placement of the heart valve stent released from the catheter tip of the delivery catheter system can only be achieved if the anchoring / positioning arches, which must engage in the leaflets of the native heart valve, have a minimum length of 5 to 25 mm.
[0030] However, this presents the problem that anchoring / positioning arches of this size cannot simultaneously turn from cranial (distal) to caudal (proximal) at the implantation site, i.e., in the ascending aorta, because the ascending aorta does not usually offer enough space in terms of diameter or cross-sectional area for this.
[0031] Based on this problem, the present invention aims to provide a delivery catheter system with which a stent, in particular a heart valve stent, can be deployed even in the region of, for example, the ascending aorta, wherein the stent, in particular a heart valve stent, has corresponding anchoring / positioning arcs that fold from the catheter tip of the delivery catheter system from cranial to caudal. MEISSNER BOLTE A / FIG-025-PC 6
[0032] This problem is solved in particular by an insertion catheter system according to independent claim 1, wherein advantageous further developments of the insertion catheter system according to the invention are specified in the dependent claims.
[0033] Accordingly, the invention relates in particular to an insertion catheter system for inserting a radially compressed stent, in particular a heart valve stent, into the body of a patient and for placing the stent at an implantation site, in particular in the heart of the patient.
[0034] The stent has a base body, particularly a lattice-shaped one, with a proximal end and an opposing distal end, and at least two attachment / anchoring / compartmentalizing / positioning arches. Compartmental arches can be particularly advantageous in stents for use in / with drug-eluting valve prostheses (DEVs), in order to separate the tissue or material to be treated from the bloodstream by means of the at least two compartmental arches and to release one or more drugs in this separated compartment for pharmacological treatment.
[0035] The fixing / anchoring, compartmentalizing, and positioning arches are specifically designed to engage in the pockets of a native heart valve when the stent is implanted, thus positioning and holding the stent body at the implantation site in the patient's heart.
[0036] At the implantation site, the stent can be transformed from its compressed form into an expanded form, whereby in the implanted state of the stent it exists in its expanded form.
[0037] According to the invention, it is particularly provided that the at least two fastening / anchoring / compartmenting / positioning arcs are aligned cranially in the compressed form of the stent towards the distal end region of the base body and caudally in the expanded form of the stent towards the proximal end region of the base body.
[0038] With regard to the delivery catheter system according to the invention, it is provided that this is a catheter system through which the stent in its compressed MEISSNER BOLTE A / FIG-025-PC 7
[0039] The catheter system has a form that can be inserted into the patient's body, a catheter tip provided at the proximal end of the catheter system in which the stent can be received in its compressed form, and a handle provided at the distal end of the catheter system with which the catheter tip can be manipulated.
[0040] The insertion catheter system according to the invention is characterized in particular by the fact that the handle has actuating means which interact with the catheter tip in such a way that, when the actuating means are actuated, the at least two fastening / anchoring / compartmenting / positioning arcs of the stent can be successively released step by step from the catheter tip according to a predetermined or definable sequence of events.
[0041] A sequential release of the at least two anchoring / compartmenting / positioning arcs of the stent from cranial to caudal is possible with this invention through a modification of the delivery catheter. The term 'sequential release' here implies that the predetermined or definable sequence of events not only has a specific order, but can also be interrupted and thus temporally controlled, for example, by means of the handling mechanism.The invention thus allows the design and use, in particular, of heart valve prostheses equipped with corresponding fastening / anchoring / compartmenting / positioning arches, which do not have the disadvantage that the fastening / anchoring / compartmenting / positioning arches must be inserted caudally next to the heart valve body even before release (for example, in the insertion state) and thus increase the diameter of the heart valve prosthesis.
[0042] The present invention allows the fastening / anchoring / compartmenting / positioning arches to fold down sequentially only during release from the introducer catheter, so that the fastening / anchoring / compartmenting / positioning arches are oriented cranially in the insertion state, thus reducing the circumference of the introducer catheter. MEISSNER BOLTE A / FIG-025-PC 8
[0043] The invention thus allows the production of radially smaller insertion catheters despite the insertion of heart valve prostheses with the above-mentioned versatile indication spectrum (low or no calcification, infected heart valves) and thus enables an expanded therapy concept.
[0044] According to implementations of the insertion catheter system according to the invention, the catheter tip has a fixing device for releasably fixing at least in particular the proximal end region of the base body in the catheter tip and a receiving device for at least partially or partially receiving at least the distal end region of the base body and at least the end regions of the at least two fastening / anchoring / compartmenting / positioning arcs.
[0045] The receiving device may have a first distal receiving section, in particular designed in a sleeve-like or sleeve-like manner, for receiving at least part or area at least the end regions of the at least two fastening / anchoring / compartmenting / positioning arches.
[0046] In addition, the receiving device may also have a proximal second receiving section, in particular designed in a sleeve-like or tube-like form, for receiving at least part or area of the stent's base body.
[0047] In this context, it is advantageous that the handle has at least one first actuating means assigned to the first receiving section and, if necessary, a second actuating means assigned to the second receiving section, wherein the first actuating means interacts with the first receiving section in such a way that, when the first actuating means is actuated, a predetermined or definable longitudinal displacement of the first receiving section relative to the fixing device, particularly in the distal direction, can be effected, and wherein the second actuating means interacts with the second receiving section in such a way that, when the second actuating means is actuated, a predetermined or definable longitudinal displacement of the second receiving section relative to the fixing device, particularly in the proximal direction, can be effected.
[0048] According to embodiment variants of the aforementioned realizations of the insertion catheter system according to the invention, it is provided that the second MEISSNER BOLTE A / FIG-025-PC 9
[0049] The receiving section is located at a proximal end of the catheter tip, and the first receiving section is positioned between the second receiving section and the handle.
[0050] In this context, it is conceivable that the second receiving section can be moved away from the handle in the longitudinal direction of the catheter tip relative to the fixation device when the second actuating means is activated, while the first receiving section can be moved towards the handle in the longitudinal direction of the catheter tip relative to the fixation device when the first actuating means is activated.
[0051] Furthermore, there are design variants that release the several receiving devices, which are particularly sleeve-shaped or sleeve-like, simultaneously or sequentially in a coupled movement, whereby the coupling can be designed with a time delay and can be implemented mechanically and temporally controllable via the handling.
[0052] To gradually release the at least two fixation / anchoring / compartmenting / positioning arches from the catheter tip, the first recording section can be designed such that, starting from a state in which each end area of the at least two fixation / anchoring / compartmenting / positioning arches is at least partially or partially covered by the first recording section, and when the first recording section moves relative to the fixation device in a distal direction, the at least partial or partial covering of the end area of one of the at least two fixation / anchoring / compartmenting / positioning arches by the first recording section is initially removed.With further movement of the first recording section relative to the fixation device in a distal direction, the at least partial or area-by-area coverage of the end area of a further fixing / anchoring / compartmenting positioning arch by the first recording section is then eliminated.
[0053] In this context, it is conceivable that the proximal end region of the first receiving section is designed as an obliquely cut and preferably straight hollow cylinder, in particular a circular hollow cylinder. MEISSNER BOLTE A / FIG-025-PC 10
[0054] Alternatively, the proximal end region of the first recording section can be designed as a beveled and preferably straight hollow cylinder, in particular a circular hollow cylinder, with at least two transverse cutting planes.
[0055] Alternatively, the proximal end region of the first receiving section can be designed as a preferably straight hollow cylinder, in particular a circular hollow cylinder, wherein the edge surrounding the proximal base surface of the hollow cylinder is three-dimensional and in particular non-uniformly three-dimensional.
[0056] Alternatively, the proximal end region of the first receiving section can be designed as a preferably straight hollow cylinder, in particular a circular hollow cylinder, wherein at least one recess or window area is formed in the proximal side surface of the hollow cylinder.
[0057] It is conceivable that the at least one recess or window area formed in the proximal side of the hollow cylinder is designed in such a way that an end area of at least one of the at least two fixing / anchoring / compartmenting / positioning arcs can pass through this at least one recess or window area when the first receiving section is moved in a distal direction relative to the fixing device.
[0058] It is also conceivable that the at least one recess or window area formed in the proximal outer surface of the hollow cylinder is designed such that an end area of at least one of the at least two fastening / anchoring / compartmenting / positioning arcs can pass through this recess or window area when the first receiving section is rotated relative to the fixing device. In embodiments, the rotation can be adjustable up to a certain fixed or definable angle, or the rotation can be blocked for a purely translational movement, or it can be designed as a combination of translational and rotational movement resulting in a helical relative movement. MEISSNER BOLTE A / FIG-025-PC 11
[0059] According to implementations of the insertion catheter system according to the invention, the distal end region of the second receiving section has a shape that is at least partially or partially complementary to the shape of the proximal end region of the first receiving section.
[0060] According to implementations of the insertion catheter system according to the invention, it is provided that the second receiving section covers the fixation device in a radial direction, and wherein the covering of the fixation device by the second receiving section is lifted or can be lifted by a movement of the second receiving section in a proximal direction relative to the fixation device.
[0061] According to implementations of the inventive insertion catheter system, the fixation device has a crown with at least one projecting element which is designed and configured to interact with the proximal end region of the stent via a releasable engagement with a retaining element provided on the proximal region of the stent, for example in the form of a retaining eyelet.
[0062] In particular, in the insertion catheter system according to the invention, the catheter tip is rotationally symmetrical and preferably has a rounded shape.
[0063] The invention further relates to a medical device for treating a heart valve affected by inflammation and / or infection or for treating a heart valve defect, in particular heart valve insufficiency or heart valve stenosis, wherein the medical device comprises an introduction catheter system of the aforementioned type according to the invention and a stent, in particular a heart valve stent, which is received or can be received in the catheter tip of the introduction catheter system.
[0064] It is provided that the stent has a base body, in particular a grid-shaped one, with a proximal end region and an opposing distal end region, and at least two anchoring / compartmenting / positioning arcs attached to the base body, which are specifically designed to engage in the leaflets of a native heart valve when the stent is implanted, thus ensuring the MEISSNER BOLTE A / FIG-025-PC 12
[0065] The stent body is positioned and held in place at the implantation site in the patient's heart. At the implantation site, the stent can be transformed from its compressed to an expanded form, existing in its expanded state when implanted. The at least two fixation / positioning arches are oriented cranially towards the distal end of the stent body in its compressed state and caudally towards the proximal end of the stent body in its expanded state.
[0066] According to implementations of the medical device according to the invention, the stent is designed such that, when the attachment / anchoring / compartmenting / positioning arcs of the stent are released step by step, the respective released attachment / anchoring / compartmenting / positioning arc preferably folds itself from cranial to caudal in such a way that, in the folded-over state of the attachment / anchoring / compartmenting / positioning arc, it points in the direction of the proximal end region of the base body of the stent.
[0067] Preferably, the stent is made of a shape memory material, in particular a nickel-titanium alloy.
[0068] Furthermore, it is preferably provided that the at least two fastening / anchoring / compartmenting positioning arcs of the stent are integrally formed with the base body of the stent.
[0069] In particular, the medical device further comprises a replacement heart valve, especially a percutaneous or surgical replacement heart valve, which is attached to the stent.
[0070] The invention is described in more detail below with reference to the accompanying drawings and exemplary embodiments.
[0071] Shown: MEISSNER BOLTE A / FIG-025-PC 13
[0072] FIG. 1A, B each schematically and in a side view the proximal end region of the first receiving section of a first exemplary embodiment of the insertion catheter system according to the invention;
[0073] FIG. 2A, B each schematically and in a side view the proximal end region of the first receiving section of a second exemplary embodiment of the insertion catheter system according to the invention;
[0074] FIG. 3A, B each schematically and in a side view the proximal end region of the first receiving section of a third exemplary embodiment of the insertion catheter system according to the invention; and
[0075] FIG. 4 each schematically shows sectional views of an exemplary embodiment of the insertion catheter system according to the invention in a sequence explaining the release of a stent.
[0076] Figures 1A and 1B schematically show the proximal end region of the first receiving section of a first exemplary embodiment of the insertion catheter system according to the invention. In this embodiment, the proximal end region of the first receiving section is designed as an obliquely cut, straight hollow cylinder, in particular a circular hollow cylinder.
[0077] An alternative embodiment is shown in FIG. 2A, B. In detail, the proximal end region of the first receiving section is designed as a straight hollow cylinder, in particular a circular hollow cylinder, wherein the edge surrounding the proximal base surface of the hollow cylinder is three-dimensional and in particular non-uniformly three-dimensional.
[0078] Figures 3A and 3B show a further embodiment in which the proximal end region of the first receiving section is designed as a straight hollow cylinder, in particular a circular hollow cylinder, with several recesses or window areas formed in the proximal outer surface of the hollow cylinder. The recesses or window areas formed in the proximal outer surface of the hollow cylinder are each designed as follows: MEISSNER BOLTE A / FIG-025-PC 14
[0079] that an end area of a fixing7anchoring7compartmenting7positioning arc can pass through this when the first recording section is moved distally relative to the fixing device.
[0080] FIG. 4 shows schematic sectional views of an exemplary embodiment of the insertion catheter system according to the invention in a sequence explaining the release of a stent.
[0081] Specifically, the illustration in FIG. 4 shows a sequence of a release process of a self-expanding stent with two schematically shown retaining arcs.
[0082] The invention is not limited to the embodiments shown in the drawings, but results from a combination of all the features disclosed herein.
Claims
December 18, 2025 devie medical GmbH A / FIG-025-PC TR / lj INTRODUCTION CATHETTER SYSTEM FOR INTRODUCING AND POSITIONING A RADIALLY COMPRESSED CARDIOLATING TENTS INTO THE BODY OF A PATIENT AND FOR PLACING THE CARDIOLATING TENTS IN AN IMPLANTATION SITE IN THE HEART OF THE PATIENT Patent claims 1. Delivery catheter system for introducing and positioning a radially compressed stent, in particular a heart valve stent, into the body of a patient and for placing the stent at an implantation site, in particular in the heart of the patient, wherein the stent has a base body, in particular a lattice-shaped, with a proximal end region and an opposing distal end region, and at least two attachment / positioning / anchoring arcs attached to the base body, which are in particular designed to engage in the leaflets of a native heart valve in the implanted state of the stent and thus to position and hold the base body of the stent at the implantation site in the heart of the patient, wherein the stent can be converted from its compressed form to an expanded form at the implantation site, wherein in the implanted state of the stent it is in its expanded form.wherein the at least two fixing / anchoring7compartmenting7positioning arcs are oriented cranially towards the distal end of the base body in the compressed form of the stent and caudally towards the proximal end of the base body in the expanded form of the stent, and wherein the delivery catheter system comprises the following: a catheter system through which the stent, in its compressed form, can be inserted into the patient's body; a catheter tip provided at the proximal end of the catheter system, in which the stent can be received in its compressed form; and MEISSNER BOLTE A / FIG-025-PC 2 a handle provided at the distal end of the catheter system, with which the catheter tip can be manipulated, wherein the handle has actuating means which interact with the catheter tip in such a way that, when the actuating means are actuated, the at least two fastening / anchoring / compartmentalizing / positioning arcs of the stent can be successively released from the catheter tip step by step according to a predetermined or definable sequence of events.
2. Insertion catheter system according to claim 1, wherein the catheter tip has a fixing device for releasably fixing at least the proximal end region of the base body in the catheter tip and a receiving device for at least partially or partially receiving at least the distal end region of the base body and at least the end regions of the at least two attachment / anchoring / compartmenting / positioning arcs, wherein the receiving device has a first distal receiving section, in particular designed in a sleeve-like or sleeve-like form, for at least partially or partially receiving at least the end regions of the at least two attachment / anchoring / compartmenting / positioning arcs and a proximal second receiving section, in particular designed in a sleeve-like or sleeve-like form, for at least partially or partially receiving the base body of the stent, wherein the handle has at least one first actuating means associated with the first receiving section and one second actuating means associated with the second receiving section, wherein the first actuating means interacts with the first receiving section in such a way that, when the first actuating means is actuated, a predetermined or definable longitudinal displacement of the first receiving section relative to the fixing device, particularly in the distal direction, can be effected, and wherein the second actuating means interacts with the second receiving section in such a way that, when the second actuating means is actuated, a predetermined or definable MEISSNER BOLTE A / FIG-025-PC 3 Longitudinal displacement of the second recording section relative to the fixation device, particularly in the proximal direction, can be effected.
3. Insertion catheter system according to claim 2, wherein the second receiving section is located at a proximal end region of the catheter tip and the first receiving section is located between the second receiving section and the handle, wherein the second receiving section is movable away from the handle in the longitudinal direction of the catheter tip relative to the fixation device when the second actuating means is actuated, and wherein the first receiving section is movable towards the handle in the longitudinal direction of the catheter tip relative to the fixation device when the first actuating means is actuated.
4. Insertion catheter system according to claim 2 or 3, wherein, for the gradual release of the at least two attachment / anchoring / compartmental / positioning arches from the catheter tip, the first recording section is designed such that, starting from a state in which each end region of the at least two attachment / anchoring / compartmental / positioning arches is at least partially or partially covered by the first recording section, and upon movement of the first recording section relative to the fixation device in a distal direction, the at least partial or partial covering of the end region of one of the at least two attachment / anchoring / compartmental / positioning arches by the first recording section is initially removed,wherein, during a further movement of the first recording section relative to the fixation device in a distal direction, the at least partial or area-by-area coverage of the end region of a further fixing / anchoring / compartmenting / positioning arch by the first recording section is eliminated.
5. Insertion catheter system according to claim 2 or 3, wherein, for the gradual release of the at least two attachment / anchoring / compartmental / positioning arches from the catheter tip, the first receiving section is designed such that MEISSNER BOLTE A / FIG-025-PC 4 Starting from a state in which each end region of the at least two fastening / anchoring / compartmenting / positioning arches is at least partially or partially covered by the first recording section, and during a rotational movement of the first recording section relative to the fixing device about the longitudinal axis, the at least partial or partial covering of the end region of one of the at least two fastening / anchoring / compartmenting / positioning arches by the first recording section is initially removed, wherein during a further rotational movement of the first recording section relative to the fixing device in a distal direction, the at least partial or partial covering of the end region of another fastening / anchoring / compartmenting / positioning arch by the first recording section is removed.
6. Insertion catheter system according to claims 4 and 5, wherein the proximal end region of the first receiving section is designed as an obliquely cut and preferably straight hollow cylinder, in particular a circular hollow cylinder.
7. Insertion catheter system according to claims 4 and 5, wherein the proximal end region of the first receiving section is designed as a beveled and preferably straight hollow cylinder, in particular a circular hollow cylinder, with at least two transverse cutting planes.
8. Insertion catheter system according to claims 4 and 5, wherein the proximal end region of the first receiving section is designed as a preferably straight hollow cylinder, in particular a circular hollow cylinder, wherein the edge surrounding the proximal base surface of the hollow cylinder is three-dimensional and in particular non-uniformly three-dimensional.
9. Insertion catheter system according to claims 4 and 5, wherein the proximal end region of the first recording section is a preferably straight hollow cylinder, in particular circular MEISSNER BOLTE A / FIG-025-PC 5 hollow cylinder, wherein at least one recess or window area is formed in the proximal side surface of the hollow cylinder.
10. Insertion catheter system according to claim 9, wherein the at least one recess or window area formed in the proximal side of the hollow cylinder is designed such that an end area of at least one of the at least two attachment / anchoring / compartmenting / positioning arcs can pass through this at least one recess or window area when the first receiving section is moved in a distal direction relative to the fixation device.
11. Insertion catheter system according to any one of claims 2 to 10, wherein the distal end region of the second recording section has a shape that is at least partially or partially complementary to the shape of the proximal end region of the first recording section.
12. Insertion catheter system according to one of claims 2 to 11, wherein the second receiving section covers the fixing device in a radial direction, and wherein the covering of the fixing device by the second receiving section is removed or can be removed by a movement of the second receiving section in a proximal direction relative to the fixing device.
13. Insertion catheter system according to any one of claims 2 to 12, wherein the fixation device has a crown with at least one projecting element which is designed and configured to be complementary to a retention element provided on the proximal region of the stent, for example in the form of a retention eyelet, and engages with the proximal end region of the stent via a releasable engagement to cooperate. MEISSNER BOLTE A / FIG-025-PC 6 14. Insertion catheter system according to any one of claims 1 to 13, wherein the catheter tip is rotationally symmetrical and preferably has a rounded shape.
15. Medical device for treating a heart valve affected by inflammation and / or infection or for treating a heart valve defect, in particular heart valve insufficiency or heart valve stenosis, wherein the medical device comprises an introduction catheter system according to one of the preceding claims and a stent, in particular a heart valve stent, received or receptible in the catheter tip of the introduction catheter system, wherein the stent has a base body, in particular a lattice-shaped one, with a proximal end region and an opposing distal end region, and at least two attachment / anchoring / compartmentation / positioning arcs attached to the base body, which are in particular designed to engage in the leaflets of a native heart valve in the implanted state of the stent and thus to position and hold the base body of the stent at the implantation site in the patient's heart.wherein the stent can be transformed from its compressed form to an expanded form at the implantation site, wherein in the implanted state the stent is in its expanded form, wherein the at least two attachment / anchoring / compartmenting / positioning arches are oriented cranially towards the distal end of the base body in the compressed form of the stent and caudally towards the proximal end of the base body in the expanded form of the stent.
16. Medical device according to claim 15, wherein the stent is designed such that, during the stepwise release of the stent's fixation / anchoring / compartmentation / positioning arcs, the respective released fixation / anchoring / compartmentation / positioning arc preferably folds itself automatically from cranial to caudal such that, in the folded-over state, the fixation / anchoring / compartmentation / positioning arc points towards the proximal end region of the stent's base body. MEISSNER BOLTE A / FIG-025-PC 7 17. Medical device according to claim 15 or 16, the stent is made of a shape memory material, in particular a nickel-titanium alloy.
18. Medical device according to one of claims 15 to 17, wherein the at least two fastening / anchoring / compartmenting / positioning arcs of the stent are integrally formed with the base body of the stent.
19. Medical device according to any one of claims 15 to 18, wherein the medical device further comprises a replacement heart valve, in particular a percutaneous or surgical replacement heart valve, which is attached to the stent.