Device for repairing atrioventricular heart valves

Abstract

The present invention relates to the field of minimally invasive surgical and interventional cardiology devices for cardiac valve repair. In particular, it relates to an instrument for minimally invasive repair of atrioventricular cardiac valves, mitral cardiac valves, and tricuspid cardiac valves, as well as a corresponding method. In particular, the instrument includes a first tube having a tube axis defining an axis; a leaflet grasping structure disposed in the distal portion of the first tube and adjacent to the first tube, the leaflet grasping structure including a body and jaws that are movable relative to the body; wherein the jaws include a first abutment surface facing proximally, and the body includes a second abutment surface facing distally; the instrument further includes a needle, wherein the needle is hollowed out and forms an inner tube, and wherein the needle is releasable from the first tube and axially movable relative to the body, whereby the leaflet grasping structure is capable of clamping the leaflets of the cardiac valve between the first and second abutment surfaces; and wherein the jaws are formed to allow the needle to extend through the jaws when the leaflets are clamped.

Description

Technical Field

[0001] The present invention relates to the field of minimally invasive surgical and interventional cardiology devices for cardiac valve repair. In particular, it relates to instruments for minimally invasive repair of atrioventricular cardiac valves, mitral cardiac valves or tricuspid cardiac valves, and corresponding methods. Background Art

[0002] Prolapse of the mitral valve leaflets into the left atrium and resulting valvular insufficiency can lead to severe cardiac dysfunction. One cause of such prolapse is that the tendons (chordae tendineae) that connect the mitral valve leaflets to the papillary muscles via the left ventricle are damaged. Such damage may be the result of, for example, myocardial infarction, tissue degeneration or infectious diseases.

[0003] Repair of such prolapse requires reattachment of one or more leaflets to the papillary muscles, for example via synthetic fibers such as fibers. Such methods according to the prior art require suturing the implant to the papillary muscle. The first drawback of such a repair process is that it is only possible when the heart is not active, so surgical repair requires the heart to stop and bleed, while using extracorporeal circulation. The second drawback is that the success of the surgery depends to a large extent on the skills of the surgeon. Another drawback is that the fibers sutured to the leaflets may cause long-term damage.

[0004] Most of the laparoscopic and minimally invasive techniques and tools developed cannot meet the requirements for mitral valve repair on a beating heart. Although certain annuloplasty techniques and instruments that can suture an annuloplasty ring as part of vascular repair or coronary artery bypass surgery can be used in conjunction with a beating heart, these annuloplasty procedures.

[0005] WO2009 / 052528A2 relates to a device for performing minimally invasive leaflet repair using a clamping mechanism adapted to grasp and release valve leaflets in a beating heart. Thus, the instrument includes a needle assembly and a suture cartridge. Before starting the surgery, the sutures to be used must be passed through the openings on the cartridge assembly. The mechanism performed by the instrument includes pulling the sutures through the leaflets and tightening the first suture using prolene sutures. Subsequently, each suture must be fixed to the epicardium near the ventriculotomy using knots and swabs. The complete mechanism is time-consuming and error-prone. In addition, the method based on suture characteristics has the drawback that suturing is difficult in minimally invasive surgery and thus it is generally difficult to achieve sufficient and reliable stability.

[0006] WO2017 / 066890A2 discloses an atrioventricular heart valve repair device and corresponding method, in which the device implements a leaflet grasping mechanism. The leaflet grasping mechanism includes a first arm having a proximally facing abutment surface and a second arm having a distally facing abutment surface, wherein the arms are movable relative to each other such that a leaflet can be grasped and clamped between the first and second abutment surfaces. It has been found that this configuration causes problems during echocardiographic positioning and placement of the device. In addition, the control mechanism is rather complex.

[0007] Although these inventions represent significant progress over open heart techniques for heart valve repair, further improvement of these techniques would be beneficial. Summary of the Invention

[0008] The object of the present invention is to provide a device for repairing atrioventricular heart valves, in particular mitral or tricuspid heart valves, and a corresponding method, which device and method overcome the disadvantages of prior art devices and methods and ensure easy implantation, are also suitable for transcatheter procedures and provide a reliable and well tissue - compliant repair. Transcatheter procedures are performed in a minimally invasive manner on a beating heart, and during the procedure the leaflets must be kept stationary, and the device and method should provide a solution for this. In particular, it should be possible to easily check the orientation and position of the device using echocardiography.

[0009] These objects are achieved by the present invention as defined in the claims. According to one aspect of the present invention, there is provided a device implementing a leaflet grasping mechanism by a leaflet gripping structure. The leaflet grasping mechanism includes a first proximally facing abutment surface and a second distally facing abutment surface, wherein these abutment surfaces are movable relative to each other such that a leaflet is grasped and clamped between the first abutment surface and the second abutment surface. The device is suitable for transcatheter procedures.

[0010] The present invention relates to a device for minimally invasive repair of atrioventricular heart valves, which device includes a first tube having a tube axis defining an axis, and a leaflet grasping structure disposed in a distal portion of the first tube and adjacent to the first tube. The leaflet grasping structure may include a body and jaws, whereby the leaflet grasping structure is capable of clamping a leaflet of a heart valve between a first and a second abutment surface. Thus, the jaws are movable relative to the body and include a first proximally facing abutment surface. The body includes a second distally facing abutment surface. The device may also include a needle, in particular a hollow needle forming an inner tube. The needle may be released from the first tube and is axially movable relative to the body. The body and the jaws have a channel formed to allow the needle to extend therethrough when a leaflet is clamped. The channel may have a non - centered position relative to the tube axis. This position of the channel is selected to allow the needle to pierce the leaflet relatively far from the leaflet edge. The device according to the present invention is particularly suitable for transcatheter procedures.

[0011] One embodiment relates to an instrument in which the jaws are axially movable along a straight axis. Thus, the axis is defined by the tube axis. This means that the jaws and the body can be separated by the movement of the jaws in the axial direction (the jaws move away from the body; distal movement). Of course, the jaws and the body can also be connected or joined by the movement of the jaws in the axial direction (towards the body, proximal movement). This can be used to grasp the leaflets of a valve.

[0012] The needle of the instrument is hollowed out to form a needle tube (referred to herein as the "inner tube"). Inside the needle, a tendon and a part of an implant, for example, can be arranged. The tendon can be pre-mounted on the implant part with a fixed or adjustable length. For example, the adjustable length can be achieved by a sliding knot. Alternatively, the tendon may have to be mounted on the implant part or one of the implant parts in a separate method step. The present invention relates to embodiments in which the hollow needle of the instrument is arranged inside the leaflet grasping structure and is axially movable relative to the leaflet grasping structure for release from the inside. Thus, the grasping structure has a channel in which the hollow needle can be arranged inside the channel or can be advanced through the inside of the channel. The channel can at least partially continue the lumen of the first tube and extend through the body and the jaws parallel to the tube axis. The channel part in the body and the jaws can cooperate such that in the closed position of the leaflet grasping structure, the lumen is continuous. When the leaflet is clamped between the first and second abutting surfaces, the hollow needle can be advanced through the lumen of the channel in the leaflet grasping structure to pierce the leaflet.

[0013] The body of the instrument according to the present invention may further include a corresponding part that can be released from the first tube and is axially movable relative to the body. The corresponding part includes a second abutting surface facing distally, and the second abutting surface can be pressed against the first abutting surface by a force directed in the distal direction. One embodiment relates to an instrument according to the present invention, in which the hollow needle is arranged inside the corresponding part and is capable of moving axially relative to the corresponding part to be released from the inside of the corresponding part to pierce the leaflet when the leaflet is clamped between the first and second abutting surfaces. The corresponding part can be straight relative to the axis and can move in a straight axial direction.

[0014] In an alternative embodiment, the grasping structure does not have a corresponding part of the body, but the body itself forms a corresponding part by having a second abutting surface facing distally.

[0015] In each case, the grasping of the leaflet can be accomplished by relative movement of the jaws and a part (body; separate corresponding part) having a second abutment surface. Generally, the body and the jaws can be arranged to open and close again. Thus, the jaws can move axially in both directions (forward and backward) or at least in one direction (away from the body) relative to the body. Additionally, in the presence of a corresponding part, the corresponding part can move axially in both directions (forward and backward) or at least in one direction (towards the jaws). Alternatively, the body and the jaws can be formed to only close. In this case, the body and the jaws are configured to be introduced into the patient's body in an open form (at a distance), and one of the jaws and the body or a part of the body (such as the corresponding part) can move axially towards the other part.

[0016] The second abutment surface can be constituted by a pressing pad formed by the distal end surface of the corresponding part, which can be released from the first tube and / or the body and is axially movable relative to the body. The corresponding part or at least its distal part can be, for example, substantially tubular (cylindrical) or have the shape of a slotted tube to release the needle when the leaflet is clamped. The corresponding part can also have a rectangular, pentagonal or hexagonal cross-sectional area.

[0017] The pressing pad formed by the corresponding part or by the body itself can have a circular outer contour or can also be angular (such as rectangular or pentagonal or hexagonal, etc.). The pressing pad can be provided with a buffer pad especially at its distal end to prevent tissue damage. The needle channel within the grasping structure can be located within the body (and, if applicable, its corresponding part) and the jaws. The dimensions of the channels located in the jaws and the body are adapted to each other such that the distally facing abutment surface and the proximally facing abutment surface of the jaws (in the leaflet grasping position) are substantially overlapping, while the axial continuation of the inner cavity within the corresponding part coincides with the innermost part of the channel so that the needle released from within the corresponding part when the corresponding part is pressed against the jaws is not obstructed. More specifically, when the grasping structure is in the closed position, the mouths of the channel body part and the channel jaw part are substantially coincident, except for a slight axial offset due to the thickness of the grasped leaflet.

[0018] More specifically, the hollow needle of the instrument can be arranged inside the body and is axially movable relative to the body to be released from within the body (including, if applicable, the corresponding part) to pierce the leaflet when the leaflet is clamped between the first and second abutment surfaces. The instrument, especially the leaflet grasping structure, is formed such that the needle in the fully extended position protrudes from the distal end of the leaflet grasping structure, especially from the distal opening of the jaws. This is very important for being able to place the implant in the correct manner, especially for placing the distal part of the implant in the ventricle (such as the papillary muscle) through a trans-femoral (retrograde) procedure.

[0019] In an embodiment, the first and / or second abutment surfaces are structured. The structures may be selected to increase the grip of the grasping mechanism. Thus, the structures may include notches, corrugations, pyramids or truncated pyramids. It is particularly suitable to construct the abutment surfaces in such a way that complementary structures occur on both surfaces. Thus, the first and second abutment surfaces may cooperate with each other.

[0020] In an embodiment, the first and second abutment surfaces (in the clamping position) define a plane perpendicular to the tube axis. The abutment surfaces may also be formed to define a plane that forms an angle between 20° and 90°, and preferably between 30° and 80°, with the tube axis. Non-planar (curved) abutment surfaces are also possible.

[0021] In an embodiment, the first and second abutment surfaces include at least two different portions, each portion matching a corresponding opposite portion of the respective surface. The surface structures of these portions may be different. For example, only one portion has a surface structure, such as corrugations or pyramids, while the other portions are formed by smooth surfaces. Additionally or alternatively, when the surfaces are adjacent to each other, these portions may differ in terms of the angle formed by the tube axis and the plane defined by the opposite portions of the surface. One embodiment relates to first and second abutment surfaces that are formed to include two portions and a third portion disposed between the two portions. The two portions define a plane that forms an angle of 90° or nearly 90° with the tube axis, and the third portion defines a plane that forms an angle between 30° and 75° with the tube axis. This embodiment facilitates lobule grasping by providing a large surface area for lobule grasping and an optimized grip. Thus, the abutment surfaces that define a plane inclined to the tube axis help increase the area of the lobule to be grasped. The three-part structure of the abutment surfaces or any other structure where the abutment surfaces are not perpendicular to the axis is particularly suitable for increasing the distance between the area to be grasped and the lobule edge.

[0022] Another embodiment of the present invention relates to an instrument, wherein the grasping structure comprises at least one folding structure, such as a folding bracket such as a wire loop or a wire bracket, to support the process of bringing the gripper into the correct orientation relative to the leaflet and / or to increase the area of the leaflet that can be grasped and / or to stabilize the leaflet after grasping. Such a folding feature may be attached to the body and / or the jaws, so as to be in the same horizontal plane as the adjacent surface. For example, the folding structure may be a folding bracket attached to the jaws or attached to the body. Alternatively, the grasping structure may comprise two folding brackets. These may be in the form of wire loops, one fixed to the jaws and one fixed to the body. Another possibility is two folding brackets, both fixed to the body or the jaws to form a support structure. If more than one folding bracket is attached, preferably, these wire brackets are completely fixed parallel to the plane formed by the first and second adjacent surfaces in the closed position. Thus, preferably, in the closed position, the adjacent surfaces and the optional one or more folding brackets define the same plane. In addition, the folding bracket may be arranged to fold against the grasping structure, for example at least partially in a recess of the grasping structure, and may swing out, for example, before or during the opening of the grasping structure when released from the outer tube.

[0023] The instrument according to the present invention may further comprise an anchor carrier arranged within the inner tube of the needle and axially movable relative thereto, the anchor carrier being configured to carry at least a portion of an implant that is fixed or capable of being fixed to an artificial tendon. In an embodiment, the implant comprises a distal implant portion and a proximal implant portion and a tendon, wherein the tendon is configured to connect and, for example, connect the proximal and distal implant portions in an assembled state. In a tubular member (which may be a hollow needle or an implant cannula within a hollow needle), the distal implant portion and the proximal implant portion are arranged side by side, the proximal implant portion being arranged, for example, proximal to the distal implant portion, such that as long as the anchor carrier is within the tubular member, the tubular member prevents the proximal implant portion from detaching from the anchor carrier. In particular, the anchor carrier may axially extend within the tubular member from proximal to the proximal implant portion to at least the distal end of the proximal implant portion and may have a distal foot (stop feature) that prevents the proximal implant portion from slipping distally as long as it is within the tubular member. For example, the anchor carrier may comprise an anchor receiving recess (seat) located proximal to the distal foot.

[0024] Such implants are described in WO2017 / 066888 and systems comprising such anchor carriers are described in WO2017 / 066889. In an embodiment, the instrument or kit according to the present invention may comprise an implant as described and claimed in WO2017 / 06688 and / or an anchor carrier system as described and claimed in WO2017 / 066889.

[0025] The grasping structure including the body and the jaws can be made of metal, alloys such as stainless steel, or polymeric materials such as polyetheretherketone (PEEK). Preferably, the grasping structure (especially the polymeric grasping structure) includes at least one marker made of a radiopaque material. This at least one marker helps to track or visualize the position of the grasping structure using X-rays. Alternatively, a radiopaque polymeric material can be used to fabricate the grasping structure. The polymeric material can be made radiopaque by coupling molecules containing dense atoms (such as iodine-containing molecules) to the polymer backbone. The high radiopacity of the polymeric material can alternatively be achieved by combining a polymeric resin and a powdery radiopaque agent of uniformly shaped particles with a specific particle size distribution (such as dense metal powder or barium sulfate (BaSO4)).

[0026] There may also be markers attached to the body and / or the jaws and suitable for using X-rays to track the opening and closing of the grasping structure. The markers can be formed as strips, bands, dots, or patches within the grasping structure, or attached to the grasping structure. The markers can also be formed as small antennas or wire loops and attached to the grasping structure. These loops or antennas can protrude from the grasping structure and use echography to increase visibility. In particular, they can easily determine the orientation (azimuthal position) around the axis during operation, considering the generally required rotationally cylindrical overall shape of the grasping device (due to the rotationally cylindrical shape during the transcatheter method), which would otherwise be difficult to determine.

[0027] Generally, the markers can be made of radiopaque polymers, alloys, or metals, such as platinum-iridium alloy or tantalum.

[0028] An embodiment of the grasping structure includes notches or slots where the markers can be attached. The markers can be adhered by an adhesive. Preferably, at least one marker (or notch) is located on the lateral side of the body, and at least one is located on the lateral side of the jaws. These markers (or notches) are preferably located near or along the edge of the adjacent surface and parallel to it. This allows the operator (such as a surgeon) to determine the orientation of the grasping structure. Using X-rays, the markers can further show whether the grasping structure is closed or open and the width of the opening. The preferred form of the marker (or notch) is a curved or banana-shaped strip.

[0029] In an embodiment, the surface of the grasping structure or a part of the surface of the grasping structure has a textured surface finish, including, for example, raised microstructures or striated portions. The microstructures curve or are rounded outwardly like the exterior of a sphere or a circle. Another embodiment of the present invention relates to a grasping structure, wherein the average roughness Ra of at least a part of the surface of the grasping structure is between 1 micrometer and 40 micrometers, preferably between 5 micrometers and 20 micrometers. Thus, the surface roughness, which is a component of the surface texture, is quantified by the deviation of the true surface normal direction from its ideal form. The arithmetic mean roughness Ra is the arithmetic mean of the filtered roughness profile and is also the most widely used one-dimensional roughness parameter, which is determined by the deviation around the center line within the evaluation length.

[0030] The present invention also relates to a kit, which includes an instrument and an implant suitable for being implanted by the instrument, so as to repair an atrioventricular heart valve, in particular by replacing damaged (ruptured) chordae tendineae. Thus, the implant is preferably designed as described herein. In a further embodiment, at least the proximal implant portion and, for example, two / all implant portions can be carried by an anchor carrier, which can be surrounded by a hollow needle and possibly an additional cannula within the hollow needle. Thus, the kit can include at least two of the following: an instrument, an anchor carrier with or without a sheath, a catheter, and an implant (with or without artificial tendons). A kit including elements in a separate or pre-assembled or assembled manner can be provided.

[0031] In particular, the proximal implant portion can be assembled with the anchor carrier such that once the proximal implant portion and its mounted anchor carrier portion are outside the tubular member, it can be disengaged and automatically released (e.g., without any active mechanism causing the release), and thus only needs to be removed from the tubular member.

[0032] For example, the anchor carrier can axially extend proximally from the proximal implant portion within the tubular member to at least the center of the proximal implant portion and, for example, at least extend to its distal end or farther than its distal end. In particular, the anchor carrier can extend over the entire (proximal-distal) length of the proximal implant portion, for example, substantially as described in WO2017 / 066889.

[0033] In an embodiment, the anchor carrier can form a seat for the proximal implant portion, and once the proximal implant portion is released from the tubular member, the proximal implant portion can be disengaged from the seat by moving radially, i.e., the seat faces a radial opening but axially blocks the second implant portion as long as it is held in the seat by the tubular member.

[0034] The seat for this purpose may have a structure adapted to the shape of the proximal implant part in the initial (undeployed) state. In particular, the anchor carrier may have a distal foot portion with a channel for the tendon and a seat (also referred to herein as the shaft) proximal thereto, where the cross-section is reduced to accommodate the proximal implant part. Near the seat, the anchor carrier may have a propulsion portion having a larger cross-section than the seat, so that as long as the second implant part remains in the seat and has not been released, the propulsion movement of the anchor carrier will also push the second implant part forward.

[0035] If, in addition to the proximal implant part, the anchor carrier also carries a distal implant part, these may be arranged side by side with each other, with the proximal implant part being arranged proximal to the distal implant part. As long as the anchor carrier is within the inner tube or tube piece, the inner tube or the sleeve piece within the inner tube can prevent the proximal implant part from detaching from the anchor carrier.

[0036] As described above, the grasping structure includes a channel arranged such that a hollow needle can advance through the channel, so that at least a part of the needle can project distally beyond the grasping structure. The first abutment surface may be constituted by the area around the innermost part of the channel on the proximally facing surface of the jaw. And the second abutment surface may be constituted by the area around the innermost part of the channel on the distally facing surface of the body.

[0037] The channel is preferably further formed in such a way that, for example, a tendon extending between the released distal implant part (which will be released distally to the jaw when grasping the leaflet; implanted within the ventricle or ventricular tissue) and the proximal implant part (which will be released on the atrial side of the leaflet, for example as an anchor on the leaflet) can be released by extending therethrough and by lateral (radial) relative movement. Thus, the channel can be at least partially open to one side (unless otherwise stated, the "side" or "lateral" in this text is used to denote the direction radially with respect to the tube axis). Thus, the channel can extend to the side surface of the grasping structure. Thus, the channel can be connected to the side surface by, for example, a slit-shaped recess. Thus, the grasping structure can include a slit between the side surface and the channel for advancing the hollow needle. Thus, the present invention relates to an instrument in which the channel opens to a single lateral side.

[0038] The opening (recess) of the channel to a single lateral side or the recess of the channel can only be located within the jaw. In this case, the recess or slit preferably extends along the entire length of the jaw.

[0039] Alternatively, it may also pass through a part of the body and extend from the body to the distal end of the jaw. Thus, the recess extends along the entire length of the jaw and the distal part of the body. This allows a part of the implant to be released distally of the leaflet while another part can be released proximally of the leaflet when the leaflet is grasped. The recess may optionally be relatively narrow, but the recess may have a wider implant release portion at the position where the proximal implant portion is released when the leaflet is clamped. The width of the recess or its implant release portion may be between 0.4 mm and 0.8 mm or even extend to the entire width of the channel, and the diameter of the channel may be between 1.2 mm and 2 mm, preferably between 1.4 mm and 1.8 mm.

[0040] To guide the needle when the leaflet is pierced, especially in embodiments with a relatively wide recess (or recess implant release portion) that opens laterally to the side, the device may further include a needle guide tube that surrounds the needle and is guided within the channel. Such a needle guide tube is at least partially independent of the body and the jaw and is axially movable independently of the needle, and can be retracted relative to the needle to release the proximal implant portion.

[0041] Thus, a specific embodiment of the present invention relates to an instrument for minimally invasive repair of atrioventricular heart valves, wherein the instrument includes a first tube having a tube axis defining an axis and a leaflet grasping structure disposed in the proximal portion of the first tube and adjacent to the first tube. The leaflet grasping structure includes a body and jaws, wherein the jaws are movable relative to the body and include a first adjacent surface facing proximally, and the body includes a second adjacent surface facing distally, such that the leaflet grasping structure can clamp the leaflets of the heart valve between the first and second adjacent surfaces. The instrument further includes a needle, wherein the needle is hollowed out to form an inner tube and is releasable from the first tube and axially movable relative to the body. The body and jaws of the embodiment have a channel with a recess that extends to the side surface, wherein the recess passes through the distal portion of the body and the entire jaw.

[0042] The body and jaws of the instrument can work together to jointly form a grasping device. Thus, the jaws are movable relative to the body. This movement can be generated by an operator through an operating structure (such as an operating rod). In an embodiment, the operating rod is a push-pull wire. In other embodiments, the operating rod is a screw. One embodiment relates to an instrument as described herein that includes an operating rod adapted to operate the axial movement of the jaws and adjust the distance between the body and the jaws. Alternatively, the movement can be facilitated by a cable such as made of nitinol, and the cable can be partially surrounded by a threaded sleeve such as made of stainless steel. At the distal end of the rod or cable, a stop can be attached. The stop attaches the cable or rod to the jaw and allows the axial movement of the jaw to be facilitated by the movement of the cable or rod.

[0043] To ensure that only the jaws move axially, the instrument may include at least one guide rod (stabilizing rod) and in particular at least two stabilizing rods. At least one guide rod or at least two guide rods may be arranged to extend parallel to the screw (and the tube axis). The (multiple) guide rods may be movable relative to the jaws and / or the body part to ensure a guided axial movement, but in contrast to the operating structure (such as an operating lever), it is not provided to be operable from the outside (from the handle part).

[0044] The instrument according to the invention is suitable for transcatheter procedures for repairing heart valves. Thus, the instrument according to the invention may further include a guiding catheter that surrounds the first tube and provides a catheter leading to the first tube to reach the heart valve to be treated. Another additional tube of the instrument may be a steerable catheter. Steerable or deflectable catheters are known in the field of minimally invasive surgery. It is also possible to make the inner tube steerable. Thus, the instrument according to the invention may further include or be provided as a kit together with a handle and a transseptal steerable catheter.

[0045] For use in transcatheter procedures, it is advantageous if the instrument according to the invention can have a channel for a guide wire. Thus, the invention relates to an instrument including a wire gripping structure. A guide wire is a device for entering narrow spaces in the body (such as an obstructed valve or passage) or for assisting in the insertion, positioning, and movement of a catheter (known as the Seldinger technique for transfemoral puncture). Thus, the invention relates to such embodiments in which the body and the jaws further include a guide wire channel adapted to engage the guide wire. The guide wire channel is, for example, centered within the gripping structure. Alternatively, depending on the available space, the guide wire channel may be eccentrically arranged. The guide wire channel extends parallel to the tube axis from the proximal end of the body to the distal end of the jaws (if it is arranged centrally and coincides therewith).

[0046] An embodiment of the present invention relates to an instrument for minimally invasive repair of atrioventricular heart valves. The instrument includes a first tube having a tube axis defining an axial direction and a leaflet grasping structure disposed in the distal portion of the first tube and adjacent to the first tube. The leaflet grasping structure includes a body and jaws that are movable relative to the body; wherein the jaws include a first abutment surface facing proximally and the body includes a second abutment surface facing distally; the instrument further includes a needle, wherein the needle is hollowed out to form an inner tube, and wherein the needle is releasable from the first tube and movable relative to the body in the axial direction, whereby the leaflet grasping structure is capable of clamping the leaflets of the heart valve between the first and second abutment surfaces, and wherein the grasping structure has a channel that is not centered relative to the tube axis and is formed to allow the needle to extend through the channel while clamping the leaflets. In the embodiment, the channel opens to a single lateral side. The instrument of the embodiment further includes an operating rod and at least one stabilizing rod. The operating rod is adapted to operate the axial movement of the jaws and adjust the distance between the body and the jaws. The stabilizing rod is arranged to extend parallel to the operating rod. The body and jaws of the embodiment may further include channels suitable for incorporating a guide wire.

[0047] The hollow needle can be made of metal, such as stainless steel. The hollow needle can be formed to be suitable for piercing leaflets and ventricular tissue, such as papillary muscles or the free wall of the ventricle. Thus, the hollow needle may have a sharp distal end. Additionally, advantageously, the hollow needle has a certain flexibility. Therefore, the hollow needle can include a laser-cut portion adjacent proximally to the sharp end. Thus, the distal end of the hollow needle can be inclined relative to the tube axis. In an embodiment, the hollow needle is cut twice at different slopes. The distal portion of the cut defines a plane forming an angle of 25 to 35° with the tube axis, and the proximal portion defines a plane forming an angle of 15 to 22° with the tube axis. Within the laser-cut portion, the hollow needle includes a radial laser incision that does not cover the entire circumference of the needle (the incision is described as an open ring).

[0048] In an embodiment, the needle has a sharp distal end and a laser-cut portion (for flexibility) proximally therefrom. The laser-cut portion can be up to 30 cm long and can start from 3 cm to 10 cm proximally to the distal end of the needle. After the laser-cut portion, a polyimide tube can be added, and its length can reach the handle of the instrument.

[0049] The handle used by the surgeon to operate the instrument may include a depth indicator to control the distance of the deployed needle. Additionally or alternatively, the needle can include at least one marker that indicates the penetration depth and can be monitored by an imaging method.

[0050] Due to the described method, the device can be a fully passive structure, enabling it to be implanted into a beating heart without any active power source, except for the surgeon pulling and pushing the wire and manipulating the steerable catheter. In particular, there is no need for an active ejection of parts such as the implant part or similar components. This allows the surgeon to have good control over the operation.

[0051] In an embodiment, the device and in particular the hollow needle of the device includes an implant part with a pre-assembled or pre-assemblable configuration. In particular, the implant part may include a distal implant part anchored in ventricular tissue such as muscle tissue and a proximal implant part fixed to the leaflet and arranged, for example, proximal to the leaflet, where the tendon extends through a perforation of the leaflet to the distal implant part.

[0052] In an embodiment, the proximal implant part can be configured to lie flat on the surface of the leaflet tissue, and the tendon extends from the proximal implant part through the leaflet tissue and through the ventricle to the distal implant part. For this purpose, the proximal implant part may, for example, include a flat distal-facing abutment surface (facing distally in the implanted state, i.e., facing the side to which the tendon extends). In particular, the proximal implant part can be configured to be located only on the leaflet and thus fixed thereto - while the proximal implant part does not have any fastening mechanism extending within or through the leaflet.

[0053] Without any additional fastening mechanism (such as sutures) or artificial fastening device, only by an implant designed to include a distal-facing abutment surface located on the leaflet tissue, in particular by the tendon extending through the leaflet tissue and the ventricle to the distal implant part, possibly assisted by a distal-facing structure on the abutment surface, the proximal implant part can be held on the leaflet. This structure includes parts that project into the tissue without penetrating it, and / or is serrated relative to it to prevent movement. In particular, the proximal implant part will be placed only on one side of the leaflet after implantation and, for example, does not extend through the leaflet. The side on which the proximal implant part is located on the leaflet tissue is the upper side of the leaflet facing the atrium.

[0054] To bring the leaflet grasping structure from the closed position to the open position or vice versa, the device may include a cable pulling mechanism. Such a mechanism may, for example, include a wire appropriately guided along a first tube and the body and the jaws, which are appropriately connected to the wire to pull or push it.

[0055] Of course, other variants are possible. This includes the possibility that one or more springs automatically bring the leaflet grasping structure into the open position, and an active mechanism such as a cable pulling mechanism is provided to bring it back to the closed position.

[0056] A spring mechanism can also be used to bring the grasping structure into the closed position and hold it there. Such a spring mechanism can be located anywhere in the device, such as in the handpiece held by the operator, or it can be located within the outer tube inserted into the body. This optional spring mechanism for closing the leaflet grasping structure has two possible advantages: First, it can automatically close the grasping structure. Second, it applies a controlled and constant force on the leaflets when the leaflets are fixed.

[0057] In an embodiment, the instrument includes a feedback indicator that shows whether the leaflet grasping structure has grasped the leaflets. Such an indicator can include, for example, an optical device such as an optical waveguide that defines an optical path to the rear of the distal end, and the optical path is interrupted when the leaflets are grasped.

[0058] It has been found that the grasping structure described herein has excellent visibility in echocardiography compared to prior art devices. Accordingly, the present invention provides an instrument that offers the possibility of providing good orientation using echocardiography.

[0059] The present invention also relates to a method of replacing or supplementing damaged natural chordae tendineae of a human or animal heart by using a device as described herein. The features related to the instrument described herein may also pertain to this method and vice versa. In particular, the method may include the following steps:

[0060] - Providing an instrument that includes:

[0061] ο A first tube having a tube axis defining an axial direction;

[0062] ο A leaflet grasping structure located at the distal portion of the first tube and adjacent to the first tube, the leaflet grasping structure including a body and jaws that are movable relative to the body;

[0063] ο Wherein the jaws include a first abutting surface facing proximally, and the body includes a second abutting surface facing distally;

[0064] ο The instrument further includes a needle, wherein the needle is hollowed out to form an inner tube, and wherein the needle is releasable from the first tube and axially movable relative to the body;

[0065] ο Thereby, the leaflet grasping structure is capable of clamping the leaflets of the heart valve between the first and second abutting surfaces;

[0066] ο And wherein the grasping structure has a channel formed to allow the needle to extend therethrough when the leaflets are clamped, and the channel may have a non-centered position relative to the tube axis;

[0067] - Pushing the tube from the ventricular side towards the leaflets of the heart atrioventricular valve,

[0068] - clamping the leaflet between the first and second abutment surfaces;

[0069] -Use a hollow needle to puncture the leaflet while clamping it;

[0070] - securing the artificial tendon to the clamped leaflet; and

[0071] - Remove the first tube and leaflet grasping structure.

[0072] The step of fixing the artificial tendon may refer to a method comprising the following steps:

[0073] - A system is provided, which is arranged in a hollow needle of the device or in an inner tube in the needle, the system comprising:

[0074] o a tubular member having an outer distal end,

[0075] o a distal implant portion arranged in the tubular member,

[0076] o tendons, which are artificial or allograft or xenograft tendons arranged in a tubular member,

[0077] o a proximal implant portion disposed in the tubular member, and

[0078] o an anchor carrier arranged in the tubular element,

[0079] o the distal implant portion and the proximal implant portion are arranged side by side in the tubular member,

[0080] o the proximal implant portion is assembled with the anchor carrier within the tubular member such that the tubular member prevents the proximal implant portion from being removed from the anchor carrier as long as the anchor carrier is within the tubular member,

[0081] - advancing a hollow needle with a tubular member from the atrial side to a leaflet of an atrioventricular valve of the heart, puncturing the leaflet and advancing the hollow needle through the punctured leaflet and tissue within the ventricle, such as a papillary muscle;

[0082] - releasing the tubular member from the needle and releasing the distal implant portion from the tubular member, thereby implanting the distal implant portion into the tissue;

[0083] - retracting the tubular member (with the needle) and releasing the proximal implant portion proximal to the atrial leaflet; and

[0084] - remove the tubular piece,

[0085] - wherein the proximal implant part and the distal implant part are connected by a tendon in the system, or the method comprises the additional step of connecting the proximal and distal implant parts by a tendon.

[0086] Specifically, the present invention can provide minimally invasive treatment or repair of atrioventricular heart valves. The method particularly includes a transcatheter valve repair method. The present invention is thus compatible with different access points to the (beating) heart and is directed to different access points, such as transapical and particularly the transfemoral approach. Typically, valve replacement requires open-chest surgery through a "sternotomy" in which the chest is surgically separated. The transcatheter procedure can be done through a very small opening, leaving all the sternum in place. Thus, the transcatheter procedure provides a beneficial treatment option for patients considered at medium or high risk for standard valve replacement surgery, while also providing the additional benefit of faster recovery in most cases. BRIEF DESCRIPTION OF THE DRAWINGS

[0087] The principles and embodiments of the present invention will be described below in conjunction with the drawings. Like reference numerals in the drawings refer to the same or similar elements. The drawings show:

[0088] Figure 1 is a schematic view of an instrument having a grasping structure, including a body, jaws, and corresponding parts.

[0089] Figure 2 is Figure 1 a schematic view of the instrument in which the corresponding parts have been moved axially towards the jaws.

[0090] Figure 3 is Figure 1 a schematic view of the instrument in which the needle has been moved axially through the jaws.

[0091] Figure 4 is a schematic view of an instrument having a grasping structure according to the present invention, the grasping structure including a body and jaws.

[0092] Figure 5 is according to Figure 4 a schematic view of the instrument in which the view has been changed.

[0093] Figure 6 is according to Figure 4 a schematic view of the instrument in a closed configuration.

[0094] Figure 7 is according to Figure 4 a schematic view of the instrument in which the needle passes through the jaws.

[0095] Figures 8A to 8C is Figure 4 a schematic view of the instrument in an open configuration in a perspective view with a different orientation.

[0096] Figures 9A to 9C is a schematic view of an instrument according to the present invention, in which first and second adjacent surfaces define a plane inclined to the tube axis.

[0097] Figure 10A and Figure 10B are two representations of the grasping structure, including a support line and a lateral groove for connecting the marker strip.

[0098] Figure 11 is a schematic view of the body as part of an instrument according to the present invention, showing a lateral groove for marking.

[0099] Figure 12 is a schematic view of a jaw as part of an instrument according to the present invention, showing a lateral groove for marking.

[0100] Figure 13 and Figure 14 are grasping structure configurations with an antenna in open and closed configurations;

[0101] Figures 15 to 17 is the body of an alternative grasping structure and the grasping structure in two different states;

[0102] Figure 18 and Figure 19 is Figures 15 to 17 a variant of the grasping structure with a marker; and

[0103] Figure 20 and Figure 21 are grasping structures with a winged folding structure, in folded-in and folded-out configurations respectively. Detailed Description

[0104] The following more detailed description of the instrument embodiments is representative of exemplary embodiments of the present technology, where like components are always denoted by the same reference numerals. Standard medical reference planes and descriptive terms are used in this specification. In particular, proximal means towards the torso, or in the case of an inanimate object towards the user, while distal means away from the torso, or in the case of an inanimate object away from the user.

[0105] Figures 1 to 3 Shows an exemplary embodiment of a grasping structure as part of an instrument for repairing an atrioventricular heart valve. Figure 1 Shows the grasping structure 3 including the body 4 and the jaws 5 in the open position. The grasping structure can be formed as a bullet tip gripper (bullet tip grasping structure). The length of the grasping structure can be from 0.75 cm to 1.2 cm. The jaws can be formed as a distal nose cone tip capable of advancing on two rails to form a grasping opening. As Figure 2 shown, the body includes a second abutment surface 7 formed by a pressure pad located at the distal end of a corresponding part 19 that can be released from the body, as Figure 2 shown. The pressure pad can move axially towards the jaws to grasp and fix the leaflets. From Figure 3As can be seen, the hollow needle 8 forming the inner tube 9 can be advanced from the proximal end of the grasping structure (inside a first tube not shown in Figures 1 to 3 ) through the body, corresponding part, and the channels within the jaws to protrude from the grasping structure. When inserting the needle, it can pierce the grasped leaflet. Inside the needle, the implant can be arranged such that at least a part (distal implant part) of the implant can be implanted distally to the leaflet. The corresponding part can be formed to have a tubular or elongated base with an angular cross-section and a channel for the hollow needle. The pressing pad at the distal end of the corresponding part can be circular, having at least one incision for slicing on the guide rail.

[0106] Figure 4 to FIGS. 8 and Figures 8A to 8C show exemplary embodiments of the instrument 1 according to the present invention. The instrument is shown in different perspective views. The proximal end of the body 4 is attached to the first tube 2. The grasping structure 3, the needle 8, and the implant can be operated through the first tube. This tube may be an implant catheter. To access the heart, the instrument may include an additional outer catheter (e.g., a transseptal and guiding catheter) which can, for example, enter the right atrium through a suitable vein and from there enter the left atrium, and from there the body attached to the first tube 2 is further deployed into the left atrium to grasp the leaflet together with the jaws. The tube can be a braided sheath having a flexible part at the distal front end and a manipulation part at the proximal end. For example, it may be a Pebax catheter including a distal flexible part, providing appropriate column strength and stiffness. The first tube can provide depth translation through the transseptal and guiding catheter, thus providing alignment with the trajectory of the heart valve (e.g., the mitral valve). The first tube may also include at least one marker band, such as a platinum band.

[0107] Compared with the Figures 1 to 3 shown structure, in the Figure 4 to FIGS. 8, Figures 8A to 8C embodiment and the embodiments described below, there is no separate corresponding part that can advance relative to the body, but the body 4 itself serves as the corresponding part by including a distally facing second abutment surface 7.

[0108] The body 4 may include a channel 20 for the hollow needle 8 and a (central) guide wire channel 16 for the guide wire. The guide wire channel continues within the jaws 5 (see Figure 8C and FIG. 8D; the jaw guide wire channel part 116 is aligned with the body guide wire channel part 16). The channel 20 for the hollow needle also continues within the jaws through the jaw part 120 of the channel. When held between the first and second abutment surfaces, this channel allows the hollow needle to pass through the body and the jaws and pierce the leaflet, and a part of the implant can be released and implanted into the ventricular tissue (see below).

[0109] In Figure 4 to FIGS. 8, Figures 8A to 8CIn an embodiment, the channel (more specifically, the jaw portion 120 of the channel) has a slit-shaped lateral opening 13. After implanting at least the distal portion of the implant, the opening allows the release of an artificial tendon attached to the implant portion carried by the hollow needle. After the needle is withdrawn, the artificial tendon can be released from the gripping structure by lateral movement.

[0110] The gripping structure includes a mechanism for moving the jaws axially relative to the body. The mechanism includes an operating structure such as an operating lever and may further include one or more guide rods 15 (guide rails).

[0111] In many embodiments, the operating structure is an operating lever (which may have a bendable dimension and can thus also be regarded as an operating wire) that is axially moved directly by the operator from the outside. Alternatively, as shown, the movement can be facilitated by a screw 14. In this alternative mechanism, the operator causes the axial movement by rotating the screw. The advantage of the embodiment with a screw is that it allows for a more precise determination of the axial position without the need for feedback through monitoring, but the disadvantage is that it can sometimes be difficult to transmit the rotational (twisting) movement over a relatively long distance (e.g., up to 1 meter) through a tube.

[0112] Generally, although for illustrative purposes most figures show an operating structure in the form of a screw, the direct axial movement of an operating lever (operating wire) as well as an operating structure in the form of a screw or other operating structures are options in all embodiments of the present invention.

[0113] The length of the gripping structure in the open configuration may be from 25 mm to 40 mm. Thus, the opening width is from 8 mm to 15 mm, preferably 12 mm, the length of the body is from 10 mm to 20 mm, and the length of the jaws may be from 4 mm to 10 mm. The diameter of the gripping structure can be between 4.5 mm and 8 mm.

[0114] Figure 6 The gripping structure is shown in a closed or near-closed configuration. The leaflets can be clamped and held between the second adjacent surface 7 of the body 4 and the first adjacent surface 6 of the jaws 5.

[0115] Figure 7 The gripping structure is shown in a closed or near-closed configuration, and a hollow needle 8 is advanced to project distally from the jaws 5. The hollow needle has a sharp distal end 17.

[0116] The first adjacent surface 6 and the second adjacent surface 7 define a plane. In Figure 4 to FIGS. 8, Figures 8A to 8C in the illustrated embodiment, this plane forms a 90° angle with the tube axis. In alternative embodiments, see the embodiments described below, the angle can also be smaller.

[0117] As Figure 8A and Figure 8BAs can also be seen in other figures, the first abutment surface 6 and / or the second abutment surface 7 can be structured by surface structures 106, 107 having a protrusion / indentation pattern. Exemplarily, small pyramids with square bases are shown as surface structures 106, 107. The surface structures 106, 107 can be formed complementary. This means that in the case where the gripping structure is in the closed configuration, the structures cooperate with each other. Thus, these structures allow for enhanced gripping, but in the closed configuration, there is no risk of other structures being accidentally pinched, except for the lobules, since no open space is left between the body 4 and the jaws 5.

[0118] Figures 9A to 9C Another embodiment of the gripping structure 3 forming part of the instrument 1 according to the invention is shown.

[0119] The first difference between the embodiment described above and Figures 9A to 9C the embodiment is that the abutment surfaces 6, 7 parallel to each other are not at right angles to the axis 10, but at least have portions that are not perpendicular thereto. In particular, in Figures 9A to 9C the embodiment, at the location where the channel for the hollow needle 8 passes through the abutment surface, the abutment surface is not perpendicular to the axis.

[0120] In the specifically depicted embodiment, the first abutment surface and the second abutment surface each comprise three portions. In the closed position ( Figure 9A ), the respective portions of these abutment surfaces thus define three planes. Two planes form an angle of 90° or close to 90° with the tube axis. The plane defined by the intermediate portion connecting the perpendicular portions forms an angle β, for example, between 25 and 80° with the tube axis. The hollow needle 8 is pushed through the abutment surface within this portion that defines a plane inclined with respect to the tube axis.

[0121] Other shapes of the abutment surfaces other than perpendicular are possible, including locally curved surfaces.

[0122] One possible feature of the embodiment with abutment surfaces not perpendicular to the axis is also shown in Figure 9B . The plane 206 defined by the abutment surface near the channel for the hollow needle is not parallel to the plane 117 defined by the distal end 17 of the needle 8. Thus, when the needle pierces the gripped lobule, the distal end of the needle does not rest flat against the lobule, but rather, for example, the tip first pierces the lobule.

[0123] In particular, the intermediate plane 117 defined by the distal end can be inclined in a direction different from the inclination direction of the plane 206 defined by the abutment surface around the channel (which is the intermediate plane of the channel opening in the abutment surface) with respect to the axis, and for example, inclined in a substantially opposite direction, as shown in the illustrated embodiment.

[0124] The hollow needle 8 may include a laser cut portion 18 proximal to the sharp distal end. Such a portion includes a plurality of incisions in an otherwise cylindrical body, increasing the flexibility of the needle and allowing an implant portion to be implanted into ventricular tissue such as the ventricular wall or papillary muscle. The laser cuts extend circumferentially around the needle in the form of open rings. Thus, the incisions may have the form of circular arcs. Preferably, the laser cuts in the form of circular arcs are arranged alternately such that the positions of the uncut portions on each circle are different.

[0125] The hollow needle 8 shown is in the advanced position such that the distal end of the hollow needle projects beyond the distal end of the jaws 5. The anchor carrier or implant carrier 11 is located within the needle and is surrounded by an optional implant cannula 12 or, alternatively, directly by the needle. The implant cannula 12 and the implant carrier may be advanced to project distally from the needle. The implant carrier is designed to accommodate the implant portion. The implant may be released after removal of the implant cannula. The implant carrier may have at least a lateral seat 61 for the proximal implant portion. Its distal portion serves as a foot portion 62 for preventing the proximal implant portion from slipping out of the implant cannula 12 as long as the proximal implant portion is within the implant cannula 12 (or, if there is no implant cannula 12 at least within the hollow needle 8).

[0126] The implant cannula and the implant carrier may be made of nitinol and may also include a laser cut portion that may be formed in the same manner as the laser cut portion of the hollow needle.

[0127] Figures 9A to 9C Another feature of the embodiment is the index markings, which may be implemented in any embodiment independently of the other features described with reference to these figures. The body 4 includes a slot 21 for a marking strip and the jaws 5 include a slot 22 for another marking strip. The slots may be located near the edge of the adjacent surface and may be curved. In these slots, strips of radio-opaque material or material that produces good contrast in echocardiography (ultrasonography) may be attached. For example, strips made of platinum-iridium alloy may be glued in these slots. Such strips look like two hooks under X-rays and allow determination of the orientation of the grasping structure and whether the grasping structure is open and to what extent it is open.

[0128] Figure 10A and Figure 10B each show a representation of another embodiment of the grasping structure 3 as part of an instrument according to the invention. Figure 10A shows the grasping structure in the closed form, Figure 10B shows the grasping structure in the open position.

[0129] In addition to the features described above, the grasping structure further includes a folding bracket, such as wire bracket 23. The folding bracket or other folding structure is configured to fold and project radially outward from the cylindrical volume defined by the outer surfaces of the body and the jaws, and project, for example, from an outer catheter (such as a transseptal guiding catheter). The folding structure can automatically fold, for example, when released from such an outer catheter, when the grasping structure is opened, and / or upon a triggering action initiated by an operator.

[0130] The folding bracket increases the effective area for cooperating with the leaflets, thus facilitating the grasping of the leaflets. It can fold out from the jaws or the body. These two options can also be combined. In particular, in order to be able to support the leaflets, the wire can increase the area of at least one adjacent surface.

[0131] In the depicted embodiment, the folding bracket is a wire bracket composed of, for example, two wires. In the open position, the wires support the grasped leaflets, thereby facilitating the grasping of the leaflets. The wire bracket can be composed of a wire loop or two parallel-connected wires. Such wires may be bent at the free ends. The wire bracket of two wires is preferably arranged to include a gap between the two wires, which is aligned with the recess 13 of the channel 120 to allow the release of the tendon from the needle device.

[0132] The wire bracket can be arranged to be in close contact with the grasping structure in the closed position but project in the open position. Thus, the free ends of the wires attached to the jaws can be located in the bracket recess 123 within the body. When the jaws move away from the body, the wires are pulled out and unfolded or sprung open. The wire bracket can be made of a material with a shape memory effect, such as nitinol. Alternatively, the wires can be made of a radiopaque material or contain radiopaque markers.

[0133] Figure 10A and Figure 10B Another feature of the embodiment of and the embodiments described below is the absence of a screw for causing axial movement of the jaws relative to the body, and this further feature can be implemented independently of the other features of this embodiment. Alternatively, one or both of the rods 15 used as guide rods can be connected to a push-pull operating mechanism (basically a push-pull wire) and thus also used for operation.

[0134] Figure 11 A diagram of the body 4 of the grasping structure including a channel 16 for a guide wire and a channel 20 for a hollow needle is shown. In addition to the adjacent surface 7, the body includes a groove 21. A radiopaque marker can be incorporated within the groove 21. There may be a similar groove on the other side of the body. The groove can be 3 to 8 millimeters long, 0.15 to 0.5 millimeters deep, and the width is between 1.5 and 4 millimeters.

[0135] Figure 12 A diagram of the jaws 5 of the grasping structure, which are equipped for cooperation with Figure 11The body fitting shown. The jaws include a channel for the hollow needle, the channel having a recess 13 such that the channel opens towards the top. In addition to the adjacent surfaces, the jaws include a groove 22. A radiopaque marker can be incorporated within the groove 21. There may be a similar groove on the other side of the jaws. The groove can be 3 mm to 8 mm long, 0.15 mm to 0.5 mm deep and between 1.5 mm and 4 mm wide.

[0136] Figure 13 and Figure 14 respectively show variants of the embodiments of FIGS. 9 to Figure 12 in the closed and open states of the gripping structure. Compared to the previously described embodiments, the gripping structure includes a folding structure in the form of at least one folding antenna. In Figure 13 and Figure 14 's embodiments, it includes two folding antennas, both antennas being laterally attached to the body. The antennas protrude radially from the body and / or the jaws in the unfolded state to increase visibility when applying echography. Much like the wire stent of the above type, such an antenna can be arranged in such a way that it is closely attached to the gripping structure in the closed position but can protrude in the open position. The free end of the antenna can also be located in a corresponding recess, such as the antenna recess 151 in the jaws. When the gripping structure is opened from the outer catheter or when the jaws move away from the body, the antennas are folded out. In addition, the antennas can be made of a material having a shape memory effect such as nitinol and / or made of a radiopaque material or contain radiopaque markers.

[0137] In the embodiments described above Figures 4 to 14 's, by forming a slit-shaped recess in the jaws, the channel for the hollow needle opens towards a single lateral side, while the (proximal) body does not have such a feature. To release the proximal implant portion, the proximal implant portion (e.g., carried by an anchor carrier, as Figures 9A to 9C shown) must be opened from the body. If the proximal implant portion is located proximal to the lobule, the opening can be performed after the lobule has been released from the gripping structure.

[0138] The embodiments described below Figures 15 to 19 are equipped for the option of releasing the proximal anchor while the lobule is still being gripped. This enables additional control by the operator (i.e., both are possible): releasing the proximal implant portion while the lobule is still being gripped, or releasing the proximal implant portion after releasing the lobule.

[0139] To this end, not only the channel portion 120 in the jaw but also the main body channel portion 20 opens to the lateral side (i.e., the same side as the jaw channel portion) through the main body 4 having a recess 24 extending from the distal end. In the depicted embodiment, the recess has a narrow distal recess portion 25 and a wider proximal recess portion 26 serving as the implant release portion. The length (axial extension) and width of the recess or its implant release portion 26 (if present) are sufficient to release the proximal implant portion therefrom. In particular, the opening angle α of the main body recess portion or its implant release portion can be at least 45° or at least 60° or at least 80° or greater. This length is greater than the length of the proximal implant portion and thus greater than the length of the anchoring bearing seat portion 61.

[0140] Another optional feature is illustrated in Figure 16 and Figure 17 . That is, the hollow needle 8 is surrounded by the needle guide tube 71. During the forward (toward the distal end) movement of the needle, the needle guide tube surrounds the needle 8 substantially up to its distal end so as to pierce the lobule while clamping the lobule. The needle guide tube 71 then retracts to release the proximal implant portion. Even if the lobule exerts mechanical resistance to the forward movement / piercing and even if the proximal recess portion is relatively wide, the needle guide tube 71 ensures that the needle is guided toward and into the jaw channel portion.

[0141] Figure 18 and Figure 19 show possible positions of markings that can be used to ensure that the axial positions of the anchor carrier 11 and the implant release portion 26 are properly adjusted for implant release, even if the device is too flexible for the operator to precisely define the relative positions sufficient to open the proximal anchor only based on the markings on the handle device. In FIG. 84, the main body 4 includes a circumferential (extending 280° in the depicted embodiment) marking 84 whose axial position defines the axial position of the central anchor carrier marking 85. According to a second option, the distal anchor carrier marking 86 can be aligned with the side markings 81, 82 of the main body 4 and / or the jaw 5, and the side markings 81, 82 are present in the marking grooves 21, 22 described above.

[0142] Figure 20 and Figure 21 The embodiment of Figure 20 and Figure 21 includes a folding structure formed by the wing member 160 that can be folded out from the main body to assist in orienting the grasping structure relative to the lobule, especially as visible by echography and / or radiography. Depending on the position and structure, in embodiments different from those shown in Figure 20) The wing-like member 160 is received in the seat portion 161 so as not to project radially outwardly from the cylindrical volume defined by the outer surfaces of the body and the jaws, while in the deployed state ( Figure 21 ) they project radially outwardly from this cylindrical volume. The folding process can occur automatically when the gripping structure is released from the outer tube into which it is guided.

Claims

1. An instrument for minimally invasive repair of atrioventricular heart valves, the instrument comprising: A tubular device defining an axis and an axial direction; A leaflet grasping structure, the leaflet grasping structure comprising a body and jaws; Wherein the jaws include a first adjacent surface facing proximally and the body includes a second adjacent surface facing distally; The instrument further includes a needle, wherein the needle is hollowed out to form an inner tube, and wherein the needle is axially movable relative to the body, Thereby, the leaflet grasping structure is capable of clamping the leaflets of the heart valve between the first adjacent surface and the second adjacent surface; And wherein the body and the jaws have a channel formed to allow the needle to extend therethrough when the leaflets are clamped; Wherein the channel opens to the lateral side by means of jaws including lateral recesses or slits.

2. The instrument according to claim 1, wherein the position of the channel is not centered relative to the axis.

3. The instrument according to claim 1 or 2, wherein the jaws are axially movable relative to the body.

4. The instrument according to claim 1, wherein the instrument further includes an anchor carrier disposed within the inner tube and axially movable relative to the inner tube, the anchor carrier being configured to carry at least a portion of an implant that is fixed or capable of being fixed to an artificial tendon.

5. The instrument according to claim 4, configured for a distal implant portion and a proximal implant portion arranged beside each other, the proximal implant portion being arranged proximally of the distal implant portion, wherein the anchor carrier forms an anchoring seat portion configured to carry the proximal implant portion of the implant.

6. The apparatus according to claim 5, wherein The inner tube or a sleeve member within the inner tube prevents the proximal implant portion from detaching from the anchor carrier as long as the anchor carrier is received within the anchoring seat portion and within the inner tube or sleeve member.

7. The instrument according to any one of claims 4 to 6, wherein the anchor carrier includes markers for determining the position by echocardiography and / or radiography, and wherein the body and / or the jaws include markers for determining the position by echocardiography and / or radiography for determining the relative position of the anchor carrier with respect to the body and / or the jaws.

8. The instrument according to claim 1 or 2, or any one of claims 4 - 6, wherein the channel has a body channel and a jaw channel aligned with the body channel, wherein the jaw channel opens to the lateral side along its entire axial length.

9. The instrument according to claim 8, wherein the distal portion of the body channel also opens to the lateral side.

10. The instrument according to claim 9, wherein the channel opens to the lateral side by means of a recess having a distal recess portion and a proximal implant release portion proximal thereto, wherein the implant release portion of the recess extends within the body, and wherein the implant release portion of the recess is wider than the distal recess portion.

11. The instrument according to claim 10, wherein the distal recess portion has a first sub - portion extending in the jaws and a second sub - portion extending in the body distal to the implant release portion.

12. The instrument according to claim 9, wherein the opening angle α of the implant release portion that opens the channel to the lateral side is at least 45°.

13. The instrument according to any one of claims 1 or 2, or claims 4 - 6, or claims 8 - 12, further comprising a needle guide which is a tube surrounding the hollow needle and received within the channel.

14. The instrument according to any one of claims 1 or 2, or claims 4 - 6, or claims 8 - 12, wherein the channel opens on a single lateral side.

15. The instrument according to any one of claims 1 or 2, or claims 4 - 6, or claims 8 - 12, wherein the first adjacent surface and the second adjacent surface define at least one plane at an angle other than 90° to the tube axis at a position around the mouth of the channel in the first and second adjacent surfaces.

16. The instrument according to claim 15, wherein the distal end of the needle defines a needle distal plane at an angle other than 90° to the axis, and wherein the needle distal plane is inclined in a different direction from the plane defined by the first adjacent surface and the second adjacent surface.

17. The instrument according to any one of claims 1 or 2, or claims 4 to 6, further comprising an operating mechanism adapted to operate the axial movement of the jaws relative to the body and to adjust the distance between the body and the jaws, wherein the operating mechanism comprises a push - pull rod or a screw.

18. The instrument according to claim 17, further comprising at least one guide rod configured to prevent non - axial movement of the jaws relative to the body.

19. The instrument according to any one of claims 1 or 2, or claims 4 to 6, wherein the body and the jaws further comprise a guide wire channel adapted to engage a guide wire.

20. The instrument according to any one of claims 1 or 2, or claims 4 to 6, wherein the needle has a sharp distal end and a laser - cut portion proximal thereto.

21. The instrument according to any one of claims 1 or 2, or claims 4 to 6, wherein the tubular device comprises a first tube, wherein the leaflet - grasping structure is provided at the distal portion of the first tube and adjacent to the first tube, and wherein the needle can be released from the first tube and can move axially relative to the body.

22. The instrument according to any one of claims 1 or 2, or claims 4 to 6, wherein the tubular device comprises an outer catheter configured as a guiding catheter, the size of the outer catheter being designed to accommodate the leaflet - grasping structure inside the outer catheter.

23. The instrument according to any one of claims 1 or 2, or claims 4 to 6, wherein each of the jaws and the body includes a marker for determining the relative position of the jaws and the body by echography and / or radiography.

24. The instrument according to any one of claims 1 or 2, or claims 4 to 6, further comprising a folding structure configured to fold out and, when folded out, project radially outwardly from a cylindrical volume defined by the outer surfaces of the body and the jaws.

25. The instrument according to claim 24, wherein the folding structure is a folding bracket that extends over a region of at least one of the adjacent surfaces.

26. A kit comprising an instrument according to any one of the preceding claims, and further comprising an implant having a proximal implant portion, a distal implant portion, and a tendon connected or configured to connect the proximal implant portion and the distal implant portion.

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