Catheter system and method for closing at least one perivalvular leak

Abstract

A catheter system (1, 1 ') for interventional procedures within a patient's heart, vasculature and / or an implant (42) secured at a patient's heart or vasculature (50, 51, 52) is described, comprising a bendable and / or steerable extension arm (12) and a guide sheath (10) having a distal section, which allows for precise and effective localization of perivalvular leaks and deployment of occlusion members. The extension arm is fixed at a distal end of the distal section of the guide sheath, or is configured to move along the guide sheath such that the extension arm protrudes from the distal end of the distal section in an operative position, where the extension arm has a lumen through which the guidewire (17) can be manipulated and which defines a longitudinal axis (15), where the catheter system further comprises at least one alignment member (20, 120, 220, 320, 420, 520), where the alignment member (20, 120, 220, 320, 420, 520) is configured to align the guidewire (17) to the extension arm (20, 120, 220, 320, 420, 520). And an alignment member having a collapsed state and configured to be deployed to a deployed state in which the alignment member is attached to the guide sheath at a predetermined position within the distal section but proximally from a distal end thereof, or the alignment member is configured to advance along the guide sheath to a predetermined position within the distal section, wherein the alignment component comprises a plurality of struts (21, 28) distributed over a circumference, and wherein each strut of the plurality of struts extends at least in sections into a radial direction and / or is inclined with respect to the longitudinal axis in the deployed state, thereby creating a radially outwardly directed force and supporting the alignment component on the heart, vasculature and / or implant of the patient. Furthermore, a method for closing at least one perivalvular leak (53) is interpreted.

Description

Technical Field

[0001] The present invention relates to a catheter system for interventional procedures in a patient's heart, vascular system and / or an implant fixed to the patient's heart or vascular system, and to a method for closing at least one paravalvular leak in the heart, vascular system and / or in the transition area between the heart or vascular system and an implant fixed to the patient's heart or vascular system using the catheter system. Background Art

[0002] Cardiovascular disease refers to a class of diseases involving the heart or blood vessels (arteries and veins), and includes stenotic heart valves, where the valve does not open sufficiently to allow adequate forward flow of blood through the valve, and / or incompetent heart valves, where the valve does not close completely. An effective therapy for these conditions is valve replacement, which can be achieved through interventional or endovascular procedures such as percutaneous valve replacement. Paravalvular leak (PVL) is a complication associated with the implantation of prosthetic heart valves, which may also occur in other implants containing valves. PVL or paraprosthetic leak refers to the passage (leakage) of blood between the structure of the implant containing the valve and the tissue of the heart or vasculature in which the implant with the valve is fixed, due to lack of proper sealing. PVL may lead to blood backflow or blood clotting in the area of ​​the implant, bringing the risk of heart failure, hemolytic anemia, and infective endocarditis. Severe paravalvular aortic regurgitation is believed to be a key cause of prosthetic valve dysfunction. Significant PVL can be treated surgically or by transcatheter deployment of an occluding member. The latter is particularly offered to patients with isolated PVL or those with very high surgical risk.

[0003] Document US2016 / 0367120A1 discloses a catheter with a distal cardioscope for detecting and repairing leaks around replacement valves in the heart. The catheter including the distal cardioscope is inserted into the heart through an introducer sheath placed through the apex of the heart, and is navigated through the left ventricle and reaches the periphery of the aortic valve ring. The optical window of the cardioscope enables visualization of the positioning of the distal end of the catheter relative to the valve, and it is possible to visualize the leak itself. For each PVL, a line is passed through the leaking part, and an occluder device is deployed along the line to repair the PVL. This method appears to be dangerous for patients with a higher surgical risk due to comorbidities and requires sophisticated imaging techniques.

[0004] Document US2019 / 0374326 A1 discloses a deployable material selected from the group consisting of a hydrogel, a sponge and a foam and a film adjacent to and containing the deployable material, wherein the deployable material is activated by exposure to a fluid or a foaming agent. However, regarding this method, a cost-effective way is needed to identify the PVL that needs to be closed. Summary of the invention

[0005] It is therefore an object of the present invention to provide a catheter system and to provide a method for closing at least one paravalvular leak which allow reliable and effective placement of an occluding member optimized for sealing a PVL, which does not require, for example, complex imaging techniques.

[0006] The abovementioned problem is solved by a catheter system having the features of claim 1 and a method for closing at least one paravalvular leak having the features of claim 12 .

[0007] In particular, the above-mentioned problem is solved by a catheter system for interventional procedures in a patient's heart, vasculature and / or an implant fixed in the patient's heart or vasculature, the catheter system comprising a bendable and / or steerable extension arm and a guide sheath having a distal section, wherein the extension arm is fixed at the distal end of the distal section of the guide sheath, or is configured to move along the guide sheath so that it protrudes from the distal end of the distal section in an operating position, wherein the extension arm has an inner cavity through which a guidewire can be manipulated and defines a longitudinal axis, wherein the catheter system also includes at least one alignment component, which has a retracted state and is configured to be expanded to an expanded state, wherein the alignment component is attached to the guide sheath at a predetermined position in the distal section but proximally from its distal end, or the alignment component is configured to be attached to the predetermined position in the distal section as it advances along the guide sheath. The catheter system may also include at least one guidewire in the inner cavity of the extension arm and a blocking member in contact with the distal guidewire section and / or the distal guidewire end of the at least one guidewire. The alignment component may include a plurality of struts distributed around a circumference, wherein each of the plurality of struts in the deployed state at least partially extends in a radial direction and / or is inclined relative to the longitudinal axis, thereby generating a radially outwardly directed force and supporting the alignment component on the patient's heart, vasculature and / or implant. Additionally or alternatively, the alignment component may include an expandable structure, such as a balloon, to allow blood perfusion. The alignment component may be an annular balloon.

[0008] The above-mentioned catheter system is used to find and identify the location of leaks in the heart, vascular system and / or in the transition area between the heart or vascular system and the implant in an accurate and effective manner, and easily and reliably position the sealing member in the leak at the identified location to close the leak.

[0009] The catheter system includes a guide sheath (e.g., a tubular member) and an extension arm, which is fixed at the distal end of the distal section of the guide sheath or extends from the distal end of the guide sheath in an operating position. The extension arm can also be formed as a tubular member to provide an inner cavity through which the guide wire can be manipulated. The guide sheath also defines a longitudinal axis, which can correspond to the longitudinal axis of the extension arm when the extension arm is straight. The catheter system can also include an outer sheath with an inner cavity, such as a tubular member, in which the guide sheath and the retracted alignment component are guided to a target area within the patient's heart or vascular system. The guide sheath can be configured to pass through an implant fixed in the heart or vascular system.

[0010] The extension arm can be bendable and / or steerable and / or rotatable, for example, at the distal section near the distal end and / or at the distal end, so as to provide a flexible extension arm. The distal end can form an outlet port. The steerable extension arm can have the following advantages: the distance between the longitudinal axis of the guide sheath and the distal end of the extension arm can be adjusted, thereby allowing the diameter of the implant, the patient's vascular system or the heart to be adjusted separately. The extension arm can be operated from the proximal end of the catheter system, for example, by a steering line, and thereby provide the flexibility of finding and identifying the position of leakage in the transition area between the heart, the vascular system and / or the heart or the vascular system and the implant. The extension arm can have a preset shape, such as a J-shape or a U-shape, and can be straightened during the system advances to the target area by the vascular system. Straightening can occur from the inside or from the outside by a rigid guide wire. When the straightening force is removed by the relative axial displacement between the extension arm and the straightening device, the extension arm will adopt a preset J-shape or a U-shape. The steerable section can be formed, for example, by laser cutting a hypotube, and the steering line can be used to control the bending and direction of the extension arm. Any suitable type of steerable catheter structure can be adopted at the bendable and / or steerable distal section of the extension arm. In one embodiment, the guide sheath can be bent at least 120 °, so that the leakage positioned backward (that is, proximally) from the distal end of the extension arm can be identified by the guide sheath. In one embodiment, the extension arm can be rotated manually or automatically around its longitudinal axis relative to the guide sheath, so as to provide further flexibility and manipulability, so as to identify leakage and close them. In one embodiment, the extension arm is configured to make it rotatable during the leakage position in the transition zone between the heart, the vascular system and / or the heart or the vascular system and the implant. If the extension arm is attached to the distal end of the guide sheath to form the distal part of the guide sheath, a rotatable connection between the guide sheath and the extension arm may be required. The motor for actuating the rotation can be arranged at the rotatable connection. If the extension arm is attached to the distal end of the guide sheath, the structure may be rotated relative to the guide sheath, for example by controls at the proximal portion of the system (handle, robot, etc.).The tubular extension arm may provide an exit port at its distal end.

[0011] At least one alignment component has a retracted state and an expanded state, and the at least one alignment component can be expanded from the retracted state to the expanded state. In addition, at least one alignment component is attached to the guide sheath at a predetermined position in the distal section but proximally from its distal end, or the alignment component is configured to be advanced along the guide sheath to the predetermined position in the distal section. Therefore, the alignment component has a predetermined distance (relative to the longitudinal direction) from the extension arm and does not interfere with the function of the implant, at which distance the PVL can be identified, but defines the position of the extension arm in the heart, vasculature and / or implant, as shown below. The alignment component is realized by a member including a strut, wherein at least a portion of the strut extends at least segmentally in the radial direction and / or is inclined relative to the longitudinal axis. The alignment component is neither expandable nor balloon. Therefore, the alignment component may include a plurality of struts distributed on a circumference, wherein in the expanded state, each of the plurality of struts extends at least segmentally in the radial direction and / or is inclined relative to the longitudinal axis, thereby generating a radially outwardly directed force and supporting the alignment component on the patient's heart, vasculature and / or implant. In one embodiment, the length of the struts can be adapted to the patient's anatomy and / or the size of the implant.

[0012] The catheter system may include one alignment component or two or more alignment components, wherein two or more alignment components are provided, which are arranged side by side along the longitudinal axis of the guide sheath. The at least one alignment component is used as a stabilizing and centering device in the expanded state of the catheter system, in particular its distal end, which is achieved by the radial force provided by a plurality of struts. Therefore, in one embodiment, the alignment component is configured to maintain the distal end of the guide sheath in a predetermined position, such as a roughly central position or a position with a preset distance from the central position relative to the surrounding heart, vascular system or implant. Therefore, the position of the extension arm fixed to the distal end of the guide sheath or protruding from the distal end of the guide sheath in the operating position is also stabilized and centered (at the central position or at a preset distance from the central position). Wherein, the operating position is the position of the extension arm, wherein the extension arm is configured to find and identify the leakage position in the transition area between the heart, vascular system and / or the heart or vascular system and the implant, and position the blocking member at the identification position in the leakage, thereby closing the leakage. For example, the alignment component may be positioned within the inflow section or outflow section of a heart valve prosthesis such that the alignment component is positioned a distance from the artificial heart valve so as not to interfere with the function of the heart valve, particularly its leaflets.

[0013] Different embodiments refer to different configurations of the at least one alignment component. In one embodiment, the alignment component comprises, in the deployed state, at least two spoke-like struts extending radially from the guide sheath, and at least one segment of a ring, circle, ellipse (in one embodiment, a complete ring, circle, ellipse), etc., connected and attached to the outer ends (ends pointing away from the longitudinal axis) of the at least two struts.

[0014] In another embodiment, the alignment component, in the expanded state, includes at least two struts extending obliquely outward from the inner wall of the guide sheath, and at least a portion of a ring, circle, or ellipse (in one embodiment, a complete ring, circle, or ellipse) connected and attached to the outer ends (ends pointing away from the longitudinal axis) of the at least two struts.

[0015] In another embodiment, the alignment component comprises a distal sleeve and a proximal sleeve, both attached to the guide sheath, and at least two struts, each strut extending between the distal sleeve and the proximal sleeve and having a curved form having one or more bends extending outwardly from the longitudinal axis in the expanded state (e.g. forming a spiral) such that together they achieve a bulbous or cylindrical outer form. In the collapsed state, the at least two struts extend parallel to the longitudinal axis. In one embodiment of the last embodiment described above, two of the at least two struts can be fixed to connecting members at the distal ends of the struts, wherein such connecting members are configured (relative to the struts) such that they also provide radial forces to the heart, vasculature or implant. For example, as described above, at least one alignment component can be positioned within an inflow segment, an outflow segment and / or the ascending aorta of a heart valve prosthesis. In one embodiment, the alignment component has an outer diameter in the expanded state in the range of 20 mm to 50 mm so as to be supported by the patient's heart, vasculature and / or implant, for example, by a heart valve chamber, a patient's main vasculature (such as the aorta or a heart valve prosthesis).

[0016] In one embodiment, the catheter system also includes at least one guide wire in the lumen of the extension arm. In one embodiment, a float is attached to the distal end of the guide wire. The float can be used to identify the location of a leak in the heart, vascular system, and / or in a transition region between the heart or vascular system and the implant, as described in detail below. In one embodiment, the float can be implemented as a balloon, which can be expanded, for example, with a solution comprising a radiopaque contrast agent. Alternatively, an umbrella-type float can be used.

[0017] The occluding member can be used to close the identified leak in the heart, vascular system and / or implant or at the transition area between the heart or vascular system and the implant. The occluding member can be advanced to the target area using an occluding catheter and an occluding guidewire, wherein the occluding catheter moves on the occluding guidewire. Any type of occluding member is suitable for closing the identified leak. In one embodiment, a coil-type occluding member (i.e., an occluding member including a coil) can be used. The coil can have a contracted or expanded configuration. The coil can, for example, adopt a (bilobed) dumbbell shape in the expanded configuration. The coil can expand the sealing material and / or fix the sealing material at the treatment site. Alternatively, the coil can cause sealing by thrombosis on the coil. In another embodiment, a stent-based occluding member can be used. For example, a self-expanding or balloon-expandable stent can be used to place and fix the sealing material in the identified leak. The self-expanding frame can be advantageous and allows better adaptation to the size and shape of the identified leak.

[0018] In one embodiment, the system can be preassembled, including a sealing member delivery catheter preassembled in a guide sheath, and the sealing member delivery catheter serves as a space holder / expander during introduction of the system into the vascular system. This provides several advantages: it facilitates surgery because fewer processing steps are required, it improves the safety of the surgery because fewer components are directly exposed to the catheterization room environment, which reduces the risk of contamination by particles and / or infectious agents, and it reduces the number of required components, thereby reducing manufacturing costs, storage space, and environmental impact. In one embodiment, various sealing members of different types, sizes, and / or shapes can be selected based on the size and shape of a specific identified leak. An expander may be required for initial placement of the guide sheath.

[0019] In one embodiment, an additional occluding body delivery catheter may be provided separately. After the first occluding member is placed, the guide sheath (and, if applicable, the guide wire) is left in place and only the used empty occluding member delivery catheter is removed. The (new) second occluding member delivery catheter is then introduced through the same guide sheath catheter and the closure procedure is performed at the second identified leak. Further leaks can be sealed accordingly.

[0020] Regarding the materials of the components of the system, the struts of the alignment component may include or consist of a shape memory material, such as Nitinol. The guide sheath, extension arms, float, and occluding member may be made of a biocompatible material (suitable for use with a catheter). The biocompatible material may be a suitable polymer, metal, and / or metal alloy.

[0021] The above objects are further solved by a method of closing a paravalvular leak at a transition area between a native heart valve structure and a heart valve prosthesis using the above catheter system.

[0022] This method for closing at least one paravalvular leak in a target area of ​​the heart, vasculature and / or a transition area between the heart or vasculature and an implant fixed at the heart or vasculature of a patient, preferably using a catheter system as described above, may have the following steps:

[0023] - advancing the distal section of the introducer sheath to the target area with the alignment feature in the retracted state,

[0024] - deploying the alignment member at a predetermined position within the distal section of the guide sheath relative to the implant and / or the heart or the vasculature, such that the alignment member is supported at the implant, the heart and / or the vasculature,

[0025] - using a curved and / or steered extension arm fixed at or protruding from the distal end of the distal section of the guide sheath to find and identify the location of the leak within the heart, vasculature and / or in the transition area between the heart or vasculature and the implant,

[0026] - Advancing the occluding member through the extension arm to the leak at the identified location using, for example, a guidewire.

[0027] The location of the leak may be identified using a float attached to the distal end of the guidewire and monitoring the tension acting on the guidewire and / or extension arm.

[0028] During the search for the location of a leak within the heart, the vasculature, and / or in the transition area between the heart or the vasculature and the implant, the extension arm may be rotated.

[0029] The sealing member may be positioned within the leak at the identified location.

[0030] The above method steps and elements used by the method were partly described with respect to a catheter system. Reference is therefore made to the above explanations.

[0031] In one embodiment, a guidewire, for example, having an atraumatic tip, is advanced to the target area before the guide sheath is advanced to the target area. The catheter system is then advanced to the target area over the guidewire. In one embodiment, the guidewire lumen is separate from the guide sheath lumen. In another embodiment, the guidewire lumen is arranged in the center of the catheter system, within the guide sheath, and the guidewire used to place and advance the catheter system in the target area can further be used as a guidewire for placing the occlusion member after the extension arm is deployed.

[0032] In one embodiment, the location of the leak is identified using a float attached to the distal end of the guidewire and monitoring the tension acting on the guidewire or the force that deforms the extension arm. The method is based on the observation that there is a strong flow at the location of the PVL, and if the float is placed in this flow (also called the PVL jet), the strong flow exerts a force on the float attached to the guidewire. A force sensor detects the tension acting on the guidewire or the deformation of the extension arm. In an alternative embodiment, the leak is identified using a flow sensor disposed at the distal end of the extension arm that identifies the PVL jet. In one embodiment, in the case of a steerable extension arm, the steering mechanism can be actuated by an automated mechanism to place the distal opening of the extension arm at a location where the strongest flow occurs, for example, in the center of the PVL jet.

[0033] In one embodiment, the system may include a detector module in addition to the floating member combined with the force sensor, which detector module is configured to identify the location of a leak within the heart, the vascular system and / or within a transition region between the heart or vascular system and the implant, wherein the detector module may include, for example, an optical sensor, a force sensor, a pressure sensor and / or a flow sensor.

[0034] In one embodiment of the method, the extension arm is rotated manually or automatically during the search for the location of the leak within the heart, the vasculature and / or within the transition area between the heart or the vasculature and the implant.

[0035] In one embodiment, the occluding member is positioned within the leak at the identified location, thereby closing the leak. The occluding member can be advanced over a guidewire to the location of the leak using an occluder catheter within an introducing sheath and an extension arm.

[0036] In a final step, the catheter system is removed from the patient's heart and / or vasculature.

[0037] In one embodiment, the above method can be automated using an electronic control unit (ECU) connected to a catheter system having a processor. The ECU includes an algorithm that implements the method steps explained above and below. A needle-type movement of the extension arm along the circumference of a circle, including, for example, a predefined bend or turn, is automatically performed. This step can be actuated by a mechanism that rotates the extension arm at a specific continuous speed or in incremental steps. The needle-type incremental movement can be triggered by a predefined signal of the patient's heart cycle, for example, so that a) the distal end of the extension arm is moved (e.g., rotated) when the valve is closed, or b) the distal end of the extension arm is moved (e.g., rotated) when the valve is open. Embodiment a) allows the extension arm (and, if applicable, the float) to be moved into the PVL jet, and detects at which angular position the PVL jet exists and how strong the PVL jet is. Embodiment b) allows detection of whether there is a jet at a specific angular position. However, due to the phase of the heart cycle at that point in time, moving at a continuous speed may carry the risk of missing a leak when the leak passes through and there is no flow through the leak. In one embodiment, the extension arm movement can be triggered after each cycle or a predetermined number of cycles left between each movement. In alternative embodiments, the movement may also be performed independently of the patient's cardiac cycle.In one embodiment, the rotation step increments may be in the range from 1° to 90°, preferably in the range from 5° to 60°, more preferably in the range from 15° to 45°.

[0038] In one embodiment, the catheter system can automatically place the distal end of the extension arm near the upstream opening (PVL) of the leak and align it with the flow axis of the leak by using the position data identified by the catheter system to locate the leak. In addition, an automatic steering system integrated and / or connected to the catheter system can be used to place the distal end of the extension arm at this position. Once this position is taken, a guide wire carrying a blocking member can be advanced into the leak and optionally through the leak (automatically or manually), or a blocking member delivery catheter can be advanced over the guide wire to place the blocking member.

[0039] In one embodiment, at least one radiopaque marker may be attached to various components of the system to facilitate the method by improving visibility and indicating key locations (such as the end of the extension arm, the axial position of the alignment component, the perimeter of the alignment component, the occluding member, the float, etc.). BRIEF DESCRIPTION OF THE DRAWINGS

[0040] The various features and advantages of the present invention may be more readily understood with reference to the following detailed description and the embodiments shown in the accompanying drawings.

[0041] Figure 1 The distal end of a first embodiment of a catheter system is depicted in side view;

[0042] Figure 2 A second embodiment of the catheter system is shown in side view with the alignment component in a deployed state;

[0043] Figure 3 Shown in side view Figure 2 An embodiment wherein the alignment member is in a retracted state;

[0044] Figure 4 Visualize from top view Figure 1 An alignment component of an embodiment;

[0045] Figure 5 A second embodiment of an alignment component is shown in top view;

[0046] Figure 6 A third embodiment of an alignment component is depicted in side view;

[0047] Figure 7 A distal section of a third embodiment of a catheter system is shown in side view with an alignment component in a deployed state;

[0048] Figure 8 Depicted in a side view in a contracted state Figure 7 Embodiments of

[0049] Fig. 9 The distal end of a fourth embodiment of a catheter system is shown in side view with an alignment component in a deployed state;

[0050] Fig.10 The distal end of a fifth embodiment of a catheter system is shown in side view with an alignment component in a deployed state;

[0051] Fig.11 Visualize in side view Figure 1 Embodiments of a catheter system and a stent for a prosthetic aortic valve prosthesis;

[0052] Figure 12-14 Three steps of an embodiment of a method for closing at least one PVL at a transition area between a heart and a prosthetic aortic valve are shown in side view; and

[0053] Figure 15-18 Four steps of another embodiment of a method for closing at least one paravalvular leak at a prosthetic aortic valve are shown in top view. DETAILED DESCRIPTION

[0054] Figure 1The distal portion of a catheter system 1 according to a first embodiment is shown. The catheter 1 has an elongated tubular guide sheath 10 and a steerable and / or bendable tubular extension arm 12, which can be connected to a handle including a steering mechanism at the proximal end (not shown). As a result, the catheter can control the deflection of the distal end 13 of the extension arm 12, for example 180°. This can be achieved, for example, by constructing a catheter with a shaft (e.g., made of metal) with a special cutting pattern (embedded or coated with a polymer) that allows more bending in a certain direction, and by using a pull wire that is attached distally and extends proximally until the control element. By tightening the pull wire, the catheter is then bent. The extension arm 12 can also be moved in the longitudinal direction and can be rotated relative to the guide sheath 10. Furthermore, at the distal section of the guide sheath 10, the catheter system 1 comprises an alignment component 20 in the deployed state, the alignment component 20 having three radially extending struts 21 attached to the guide sheath 10 and one strut 22 extending circularly around the extension arm 12 and the longitudinal axis 15 of the guide sheath 10. The circular strut 22 is fixed to the outer end of each radial strut 21. The alignment component 20 is located at a distance d from the distal end of the guide sheath 10 (see Figure 1 One possibility of attaching the alignment member 20 to the guide sheath is in a continuous line which would extend between the shafts 10 and 12 and exit through an opening in the shaft 10 (e.g. Figure 6 as shown), or for example by welding or gluing it to the shaft 10.

[0055] Figure 2 and Figure 3 The second embodiment of the catheter system 1 ′ shown in FIG. Figure 1 The embodiment of the present invention is a device of the present invention, but additionally comprises an outer sheath having a distal portion 31 and a proximal portion 32, wherein the proximal portion 32 forms a chamber 33 having a larger inner diameter and outer diameter than the proximal section of the proximal portion 32 of the outer sheath for receiving the retracted alignment member 20. The distal portion 31 of the outer sheath is formed so that it realizes an atraumatic tip. The atraumatic tip of the distal portion 31 serves as an insertion aid and can be retracted and removed after the distal end of the catheter system is advanced to the target area. Figure 2 The deployed state of the alignment member 20 is shown, the alignment member 20 being released from the outer sheath by retracting the proximal portion 32 from the distal portion 31 . Figure 3 The collapsed state of the alignment component 20 is depicted, wherein the chamber 33 formed by the outer sheath covers the collapsed alignment component 20, which is folded. The folding can be similar to TAVI when the prosthesis is loaded or recaptured after partial release. When the self-expanding structure (e.g., made of a shape memory material such as Nitinol) is captured in the capsule, the structure is compressed. Depending on the cutting pattern and the type of capture of the structure, a compressed structure arrangement is formed. In addition, the extension arm is retracted into the guide sheath 10.

[0056] exist Figure 4 and Figure 5 Two embodiments of alignment components 20, 120 are compared in FIG. Figure 4 Shows Figures 1 to 3 The alignment member 20 of the embodiment of the catheter system of the present invention comprises three radial struts 21 of equal length, so that the guide sheath 10 is centered in the center of the circular struts 22. Figure 5 In the illustrated embodiment of the alignment feature 120, the guide sheath 10 is positioned off-center of the circular struts 22 achieved by the radial struts 21 of varying lengths. This configuration may be advantageous if the patient's anatomy does not allow for a centered position of the guide sheath 10.

[0057] Fig.11 Two positions are shown, such as Figure 1 The alignment feature 20 shown may be positioned relative to an implant in the form of a heart valve prosthesis, such as that implanted by transcatheter aortic valve implantation (TAVI). Fig.11 Only the stent-like structure 40 supporting the artificial heart valve is shown. Fig.11 In FIG. 1 , two possible positions of the alignment component 20 within the inflow section and the outflow section of the heart valve prosthesis are indicated by dashed lines, where it does not interfere with the function of the leaflets of the heart valve prosthesis. Alternatively, the alignment component is positioned outside the implant and supported directly by the patient's heart or vascular system, such as Figure 12 to Figure 14 shown (see below).

[0058] and Figure 4 and Figure 5 Compared with the embodiment, Figure 6 , another alignment component 220 is shown having a similar circular strut 22. In addition, the circular strut 22 is attached to a curved strut 25, which is attached to the inner surface of the guide sheath 10. Each curved strut 25 includes an inclined section at its distal end, which extends obliquely to the longitudinal axis 15 of the extension arm 12 and the guide sheath 10.

[0059] exist Figure 7 and Figure 8 3 shows another embodiment of the alignment member 320. In this embodiment, the alignment member 320 includes a distal sleeve 26 and a proximal sleeve 27, wherein the proximal sleeve 27 is fixed at the guide sheath 10, and the distal sleeve 26 can move in the longitudinal direction relative to the proximal sleeve 27. The distal sleeve 26 and the proximal sleeve 27 are connected by three struts 28. Figure 8 The retracted state of the alignment member 320 is shown, wherein the three struts 28 are parallel to the longitudinal axis 15 (see Figure 1) extends, and wherein the alignment component is covered by a tubular one-piece outer sheath 35. Figure 7 The deployed state is shown, in which the outer sheath 35 is retracted and the three struts 28 are bent so that together they achieve a bulbous form.

[0060] Fig. 9 Another embodiment of the alignment member 420 is shown in Figure 7 and Figure 8 This embodiment includes a distal tip 26' instead of a distal sleeve 26 to which struts 28 are attached. Fig. 9 Shows the expanded state.

[0061] Fig.10 Another similar embodiment of an alignment member 520 in an expanded state is shown in FIG. A portion of the strut 28 is attached to the distal end 26 ', such as Fig. 9 Another part (e.g., two struts 28) is attached to a distal pad 29, which is accommodated to the central distal tip 26' at a predetermined radial distance, wherein the alignment component 520 shown includes two of these pads 29. The alignment component 520 includes at least two such pads 29. Each pad 29 is supported at the inner wall of the heart, vascular system, or implant. The pad 29 is a cylindrical or cuboid element including the material.

[0062] Figure 12 to Figure 14 Steps of an embodiment of a method for closing a PVL at a transition area between a native heart valve structure 50 and an implant forming a heart valve prosthesis, more specifically, a prosthetic aortic valve 42, are shown.

[0063] First, a guidewire, preferably with a soft tip, is advanced through the vascular access site, the aorta 51 and the prosthetic aortic valve 42 into the left ventricle 52. Then, as Figure 1 The catheter system 1 shown is advanced over the guidewire until the distal tip of the guide sheath 10 is placed in the area of ​​the prosthetic aortic valve 42. Figures 12 to 14 As shown, the alignment component 20 of the catheter system is deployed in and / or in the ascending aorta 51. By means of the alignment component 20, the distal end of the catheter system has a clearly defined centered position relative to the prosthetic aortic valve 42, thereby providing greater reliability for the method for closing the PVL and allowing the prosthetic aortic valve 42 to function properly during the procedure. Alternatively, the alignment component can be deployed in the inflow tract of the prosthetic aortic valve 42. In the next step, as Fig.12As shown, the extension arm 12 is deployed from the center of the prosthetic aortic valve 42 to the periphery of the valve and forms a bend of about 180° to allow identification and positioning of the occluding member from the ventricular side of the prosthetic aortic valve 42. The extension arm may be rotatable and / or steerable, alternatively, it may be pre-shaped. Fig.12 In the next step shown, the float 18 is deployed from the extension arm 12, wherein the float 18 is attached to the float guidewire 17. The guidewire 17 and / or the extension arm 12 are connected to a force sensor (not shown) located at the proximal end of the catheter system. By rotating the extension arm about its longitudinal axis 15, it is detected whether the PVL jet force deforms the extension arm 12 and / or acts on the guidewire 17, thereby identifying a leak. This means that the extension arm 12 moves along the periphery of the prosthetic aortic valve 42 until the float 18 is captured by the blood flow and carried through the PVL, which is detected by the force sensor. The position of the extension arm 12, for which the force sensor provides a deformation signal, is maintained for subsequent steps of the catheter system 1. In the next step, an occluder delivery catheter having an occluding member 19 at its distal end is advanced along the float guidewire 17 through the guide sheath 10 and the extension arm 12, and ultimately through the PVL (see Fig.14 ). Now, the occluding member 19 is deployed in the PVL, and the float 18 and float guidewire 17 are removed from the vascular system. Alternatively, the float 18 and the distal portion of the float guidewire 17 are separated from the proximal section of the float guidewire 17 and remain at the PVL site and attached to the occluding member 19. Finally, after the entire circumference of the prosthetic aortic valve 42 is investigated for possible PVL, the delivery component, i.e., the catheter system 1, is also removed from the patient's vascular system.

[0064] about Figures 15 to 18, another embodiment of a method for closing a PVL is explained. First, a guidewire, preferably having an atraumatic tip, is advanced through a vascular access site, the aorta, and a prosthetic aortic valve into the left ventricle. Then, a catheter system 1 including a central guide sheath 10 is advanced over the guidewire until the distal tip is placed in the area of ​​the prosthetic aortic valve. In one embodiment, the catheter system 1 has a guidewire lumen that is separate from the lumen of the guide sheath 10, and the guidewire lumen has a distal exit port that is located at a position where the guidewire also exits along the valve flow axis into the left ventricle when the extension arm 12 is deployed. In another embodiment, the guidewire lumen is arranged in the center of the catheter system, and the guidewire used to place the catheter system can be further used as a guidewire for placing a closure member after the extension arm 12 is deployed. In the next step, the alignment component 20 is deployed in the inflow tract of the prosthetic aortic valve 42 and / or in the ascending aorta. In the next step, the extension arm 12 is deployed from the center of the prosthetic aortic valve 42 to the periphery of the valve and forms a bend of about 180° to allow the occluding member 56 to be positioned from the ventricular side of the prosthetic aortic valve 42. Then, by rotating the extension arm 12 and / or by manipulating the steering mechanism, the extension arm moves along the periphery of the prosthetic aortic valve 42, such as Figures 15 to 18 The extension arm 12 includes a PVL jet detector in the region of the outlet port at the distal end of the extension arm 12, which detects the flow and / or force of the PVL jet on the catheter during diastole and provides a signal to show the user when the outlet port of the catheter at the end of the extension arm 12 is near a leak 53 caused by Fig.16 Or indicated by arrow 55 in 18. In an alternative embodiment, where the extension arm 12 is steerable, the steering mechanism can be actuated by an automatic mechanism to place the distal opening of the extension arm 12 at a location where the strongest flow occurs, such as in the center of the PVL jet. When the extension arm 12 is positioned at the location of the leak 53, an occluder guidewire including an atraumatic tip can be advanced from the ventricular side through the leak into the aortic root, and optionally further into the ascending aorta. Now, the occluder delivery catheter is advanced along the occluding guidewire through the leak 53 within the guide sheath and the extension arm. The occluding member 56 is deployed in the leak 53, thereby closing the leak 53 (see Fig.17 Then, the extension arm 12 is further rotated along the periphery of the prosthetic aortic valve 42 to further search for the second leaking portion 53 (see Fig.18 ). After inspecting the entire circumference of the prosthetic aortic valve 42 and closing any detected leaks, the occluder guidewire, occluder delivery catheter, catheter system, and guidewire are removed from the patient's vasculature.

[0065] As shown in the above-described embodiments, the catheter system allows for accurate and effective positioning of the PVL and deployment of an occluding member in the PVL to seal a leak.

Claims

1. A catheter system (1, 1') for an interventional procedure in a patient's heart, vascular system and / or an implant (42) fixed to the patient's heart or vascular system (50, 51, 52), comprising a bendable and / or steerable extension arm (12) and a guide sheath (10) having a distal section, wherein: The extension arm is fixed at the distal end of the distal section of the guide sheath, or is configured to move along the guide sheath so that the extension arm protrudes from the distal end of the distal section in an operative position, wherein the extension arm has an inner lumen and defines a longitudinal axis (15) through which a guide wire (17) can be manipulated, wherein the catheter system also includes at least one alignment component (20, 120, 220, 320, 420, 520), the at least one alignment component having a retracted state and configured to be expanded to an expanded state, wherein the alignment component is attached to the guide sheath at a predetermined position within the distal section but proximally from the distal end of the guide sheath, or the alignment component is configured to be advanced along the guide sheath to the predetermined position within the distal section, wherein the catheter system also includes at least one guide wire (17) located within the inner lumen of the extension arm and a blocking member (19) in contact with the distal guide wire section and / or distal guide wire end of the at least one guide wire.

2. The catheter system according to claim 1, wherein: The alignment feature is configured to position the distal end of the introducer sheath to a predetermined position, such as a substantially central position or a position a preset distance from the central position, relative to the surrounding heart, the vasculature, or the implant.

3. The catheter system according to any one of the preceding claims, wherein: The system also includes a detector module, which is configured to identify the location of a leak within the heart, the vascular system and / or in a transition area between the heart or the vascular system and the implant, wherein the detector module may include, for example, an optical sensor, a force sensor, a pressure sensor and / or a flow sensor.

4. The catheter system according to any one of the preceding claims, wherein: The alignment feature includes a self-deployable structure and / or a mechanically deployable structure.

5. The catheter system according to any one of the preceding claims, wherein The blocking member (19) comprises a coil.

6. The catheter system according to any one of the preceding claims, wherein: The alignment member has an outer diameter in the range of 20 mm to 50 mm in the deployed state.

7. The catheter system according to any one of the preceding claims, wherein: The extension arm can be rotated and / or steered relative to the guide sheath about its longitudinal axis, either manually or automatically.

8. A catheter system according to any one of the preceding claims, wherein: The guide sheath is bendable through at least 120°.

9. The catheter system according to any one of the preceding claims, wherein: The alignment component comprises a plurality of struts (21, 28) distributed on the circumference, wherein each of the plurality of struts in the deployed state at least partially extends in a radial direction and / or is inclined relative to the longitudinal axis, thereby generating a force directed radially outwards.

10. The catheter system according to any one of the preceding claims, wherein: The alignment component includes a circular support (22) and at least a portion of a spoke-shaped support (21).

11. The catheter system according to any one of the preceding claims, wherein: The catheter system further comprises a float (18) attached to a distal guidewire end of the at least one guidewire.

12. A method for closing at least one paravalvular leak in a target area of ​​the heart, vasculature and / or a transition area between the heart or vasculature and an implant fixed to the heart or vasculature of a patient, comprising the following consecutive steps: - Advancing a guidewire through a vascular access site, the aorta, or a prosthetic aortic valve into the left ventricle of the patient's heart, - advancing a distal section of a guide sheath of a catheter system over said guide wire to a target area, wherein, The alignment component of the catheter system is in a retracted state, preferably the catheter system is a catheter system according to any one of claims 1 to 11, - deploying the alignment member at a predetermined position within the distal section of the guide sheath relative to the implant and / or the heart or the vasculature, such that the alignment member is supported at the implant, the heart and / or the vasculature, - using a bendable and / or steerable extension arm fixed at or protruding from the distal end of the distal section of the guide sheath to identify the location of the leak in the heart, in the vasculature and / or in the transition area between the heart or the vasculature and the implant, and - Using a guide wire, advance a blocking member through the lumen of the extension arm to the leak at the identified location and block the leak.

13. The method according to claim 12, wherein: The location of the leak is identified by using a float attached to the distal end of the guidewire.

14. The method according to claim 12 or 13, wherein: When searching for the location of a leak, the extension arm is rotated within the heart, the vasculature and / or in the transition area between the heart or the vasculature and the implant.

15. The method according to any one of claims 12 to 14, wherein: The tension acting on the guidewire and / or the extension arm is monitored.

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