Cardiac repair device

Abstract

A catheter device for implanting an anchor system in soft tissue and a method for using the catheter device to repair soft tissue are disclosed. The catheter device (2000) comprises a grasping device (2006) for grasping soft tissue (12), the grasping device (2006) being configured to move between a closed configuration in which the soft tissue (12) is grasped and an open configuration in which the soft tissue (12) is not grasped, the grasping device (2006) comprising a grasping device control member (2040) configured to move the grasping device (2006) between the closed configuration and the open configuration, and an anchor system deployment mechanism configured to deploy an anchor system (200) into the soft tissue (12) when the soft tissue (12) is grasped by the grasping device (2006). The gripping device (2006) includes a gripping device locking mechanism (2050) configured to lock the gripping device (2006) in a releasable closed position while the anchor system (200) is being deployed.

Description

Technical Field

[0001] The present invention relates to a catheter device for implanting an anchor system in soft tissue and a method of using the catheter device for repairing soft tissue, and more particularly to a catheter device for repairing the heart by implanting such an anchor system into the heart valve leaflets to fix artificial chordae tendineae, but not limited thereto.

Background Art

[0002] Chordae tendineae are cord-like tendons that connect the papillary muscles to the tricuspid and mitral valves within the heart. These valves are composed of valve leaflets and control blood flow and blood pressure within the heart by opening and closing in accordance with the heartbeat. Mitral valve disease is an important issue for cardiac surgeons and cardiologists. In developed countries, mitral regurgitation has become the main pathophysiological disease of the mitral valve. One of the most important causes of mitral regurgitation is the prolapse of one mitral valve leaflet. Pathological abnormalities that require repair are rupture or other degenerative changes in the chordae tendineae, valve leaflets, and other related structures. When the chordae tendineae of the mitral valve are not damaged, the valve leaflets of the mitral valve open and close synchronously, preventing valve leakage. Normal chordae tendineae can rupture acutely, causing acute decompensation in the form of heart failure. This usually results in an emergency situation that requires prompt medical intervention. In addition, damage to the chordae tendineae can occur slowly, including rupture or elongation due to a degenerative process, causing mitral valve leakage or regurgitation.

[0003] Surgical repair of the mitral valve is relatively standardized by resection of the prolapsed valve leaflet and / or implantation of a novel artificial chordal tendon to control the movement of the valve leaflet. Furthermore, a mitral valve ring is often placed to reduce the size of the mitral valve annulus. Surgical replacement of ruptured or elongated mitral chordae tendineae is very effective in removing or minimizing mitral regurgitation. This procedure is currently performed using open chest surgery. This surgery requires the use of cardiopulmonary bypass and cardiac arrest. While this surgical approach works well, it is a highly invasive procedure that can lead to serious complications, prolonged hospitalization, and considerable costs. Therefore, a less invasive approach is preferable. Similarly, a less invasive approach would be preferable for treating the tricuspid valve, which, like the mitral valve, can be susceptible to tricuspid valve disease.

[0004] Insertion of the mitral valve cusp has been performed using a minimally invasive surgical approach that enters the heart through the apex. This technique was developed by Neochord Inc. (trademark) and is described, for example, in International Publication No. 2012 / 167120, but still requires surgical incision, and the chordae tendineae are not typically inserted into the papillary muscles where they should be fixed.

[0005] International Publication No. 2008 / 101113 describes another example of a system for cardiac repair, including the implantation of artificial chordae tendineae. In the described method, an anchor can be attached to the papillary muscle and connected to the mitral valve leaflet by artificial chordae tendineae, sutures, and clips. The clips allow for adjustment of the length of the artificial chordae tendineae. A complex multi-step process is required to implant the papillary muscle anchor and sutures and join them together. The papillary muscle anchor is formed from a memory metal such as nitinol and has a "flowering" shape with sharp "petals" for hooking the anchor into body tissue. The flowering shape is flattened into a tubular shape and held within a tube that passes through the heart. The tube and anchor are then pressed against the papillary muscle, pushing the anchor out of the tube so that the petals perforate the muscle and fold outward through the muscle, firmly securing the anchor to the muscle tissue. In a subsequent surgical procedure, the artificial chordae tendineae are attached to the anchor. Next, in a further step, the suture is attached to the valve leaflet, and this suture is joined to the chordae tendineae by a clip. The suture is attached to the valve leaflet by placing a vacuum port near the valve leaflet, pulling it through the vacuum port, and puncturing it.

[0006] While this technique can avoid open-heart surgery, it will be understood that it still requires a series of relatively complex steps. An increase in the number of required steps increases the risk. Furthermore, the complexity of the device poses a risk of implanted components loosening and causing injury to the patient through embolism. In particular, clips may detach from anchors. Furthermore, as suggested, using sutures with additional clips may not be able to accurately simulate the natural chordae tendineae, and therefore may not be able to effectively repair the heart valve.

[0007] In its previous international patent application No. 2016 / 042022, the applicant disclosed a catheter device for implanting artificial chordae tendineae to repair heart valves. The catheter device of international publication No. 2016 / 042022 includes a mechanical grasping device for grasping the leaflets of a heart valve, with the leaflet anchor housed within the grasping device. The valve leaflet anchor can be formed from a flexible material such as nitinol and, in its deployed configuration, has a hook-like shape that allows it to hook onto objects. When constrained, for example, within the valve leaflet anchor channel of a gripping device, it can elastically deform into a folded configuration. The hook is straightened when the valve leaflet anchor is in its folded configuration. When the valve leaflet anchor is gripped by the gripping device, the valve leaflet anchor is pushed out of the gripping device, the hook is driven through the valve leaflet anchor, and at the same time returns to its elastically deployed configuration, fixing the valve leaflet anchor within the valve leaflet.

[0008] The device described in International Publication No. 2016 / 042022 also uses papillary muscle anchors with a nearly identical arrangement of foldable hooks. The papillary muscle anchor is held within the catheter device's tube in a folded configuration. As the hook is delivered into the heart wall and pushed out of the tube, it elastically returns to its unfolded configuration, thereby securing the papillary muscle anchor to the muscle. This papillary muscle anchor includes a locking ring that acts as a locking mechanism, clamping the artificial chordae tendineae when no force is applied. The locking ring is elastically deformable, allowing the chordae tendineae to be released from the locking mechanism to adjust their length.

[0009] In another prior international patent application, No. 2020 / 109596, the applicant disclosed further improvements to the catheter device disclosed in International Publication No. 2016 / 042022, and related new improvements. One area of ​​the improvements focused on the functionality of the mechanical grasping device. The apparatus described in International Publication Nos. 2016 / 042022 and International Publication Nos. 2020 / 109596 represents considerable progress in this field, but it has been found that further improvements in design may be beneficial. This disclosure relates in various respects to new features of the apparatus design disclosed in International Publication No. 2016 / 042022 and International Publication No. 2020 / 109588. [Overview of the project] [Problems that the invention aims to solve]

[0010] The object of the present invention is to provide an improved catheter device for implanting an anchor system in soft tissue, more preferably cardiac tissue. [Means for solving the problem]

[0011] A catheter device for implanting an anchor system in soft tissue is provided in a first aspect of the present invention. The catheter device is a gripping device for grasping soft tissue, comprising: a gripping device configured to move between a closed state in which soft tissue is grasped and an open state in which soft tissue is not grasped; a control member of the gripping device configured to move the gripping device between the closed state and the open state; and an anchor system deployment mechanism configured to deploy the anchor system into the soft tissue when grasped by the gripping device, wherein the gripping device is configured to lock the gripping device in the closed state so as to be releaseable during the deployment of the anchor system.

[0012] During the implantation of an anchor system into soft tissue, the deployment force used to deploy the anchor system may inadvertently open the gripping device. If the gripping device opens unintentionally, it can cause malfunction. For example, this could result in the anchor system being mispositioned within the soft tissue after insertion, or in unnecessary trauma to the soft tissue during implantation. To prevent the gripping device from opening unintentionally, a greater force can be applied via the gripping device's control member to keep the gripping device closed. However, this may increase the risk of trauma to the soft tissue when gripped, and may also increase the risk of malfunction of the delivery device during the operation of the gripping device.

[0013] Accordingly, the present invention provides a catheter device comprising a locking mechanism for a gripping device configured to lock the gripping device in a closed position so that it can be released during the deployment of the anchor system. By using the gripping device's locking mechanism, rather than the control member of the gripping device itself or directly, to keep the gripping device closed during deployment, it may be possible to reduce the force required to keep the gripping device arm closed. This is because the locking mechanism of the gripping device may provide a certain amount of force (i.e., a locking force) that resists the opening of the gripping device compared to the control member of the gripping device that opens and closes the gripping device. In other words, the locking mechanism of the gripping device can increase the load required to open the gripping device when it is closed, thereby reducing the force that needs to be provided by the control member of the gripping device to prevent the gripping device from accidentally opening during the deployment of the anchor system. This can improve the stability of soft tissue when it is grasped by a gripping device during the deployment of the anchor system.

[0014] The gripping device is preferably a mechanical gripping device. The catheter device may include a housing portion, which extends from the proximal end to the distal end. The gripping device may include a gripping device arm coupled to the housing portion. The gripping device arm may be configured to move between a closed position in which soft tissue is gripped and an open position in which soft tissue is not gripped. The gripping device control member may be configured to move the gripping device arm between the closed and open positions. The gripping device locking mechanism may be configured to lock the gripping device arm in the closed position so that it can be released while the anchor system is deployed.

[0015] Preferably, the gripping arm is rotatably connected to the housing and configured to rotate to move between a closed and an open position. However, in other configurations, the gripping arm may be slidably connected to the housing and configured to move between a closed and an open position by translation or sliding.

[0016] The control member of the gripping device may be a control wire, a control rod, or a control piston. The control member of the gripping device may be any suitable member for moving the gripping device arm between an open and a closed position.

[0017] The gripping device, or in particular the gripping device arm of the gripping device, may generally comprise a gripping device surface facing the housing part, and the soft tissue is gripped between this gripping device surface and the housing part. The gripping device arm can comprise a gripping device surface and a lever part configured to be separated from the housing part. The lever part may be connected, for example, directly or indirectly to the control member of the gripping device.

[0018] The gripping device, in particular the gripping device arm of the gripping device, comprises a hinge. The gripping device may be movable about the hinge. For example, the gripping device arm can be rotatably coupled to the housing part about the hinge. The hinge may be located between the gripping device surface and the lever part. The gripping device arm is hinged to the housing part, and the actuation of the lever part causes the gripping device arm to rotate about the hinge.

[0019] The gripping device, in particular the gripping device arm of the gripping device, may be joined to the housing part using a pin joint, and the pin forms the axis of rotation of the gripping device arm. The pin joint may be a rotary joint or a hinge joint, that is, the pin or cylindrical member has meshing features that couple the control member of the gripping device, and the pin forms the axis of rotation of the joint.

[0020] The control member of the gripping device can be configured to operate the locking mechanism of the gripping device. That is, the control member of the gripping device can be configured to operate the gripping device (for example, the gripping device arm) and the locking mechanism of the gripping device.

[0021] By providing a control member of the gripping device that can be used to open and close the gripping device and engage the locking mechanism of the gripping device, the configuration of the catheter device can be made simpler and more compact. For example, when operating the gripping device using only one control input, it is possible to prevent malfunction related to multiple control inputs, such as twisting or entanglement of the control wire. To achieve the complete operation of the grasping device, only one control wire routing of the grasping device is required, so the catheter device can be made more compact or simpler.

[0022] The catheter device may include a single control member of the grasping device for operating the grasping device and the locking mechanism of the grasping device. The catheter device may include a single routing for accommodating the control member of the grasping device. When the locking mechanism of the grasping device is in the closed configuration, it can be configured to releasably lock the grasping device at one of a plurality of positions. Each position can be different or can define a changing distance or separation of the grasping device for accommodating soft tissue, for example, between the grasping device arm and the housing portion.

[0023] By providing a locking mechanism of the grasping device that enables it to be locked at a plurality of positions when the grasping device is in the closed configuration, soft tissue of various sizes and thicknesses can be stably grasped by the grasping device. The locking mechanism of the grasping device may be configured to lock the grasping device arm at or towards the end of the lever portion on the tip side with respect to the rotation center of the grasping device arm. Locking the grasping device arm at a distance away from the rotation center of the grasping device arm can provide a larger locking force moment to counteract the deployment force applied to the grasping device arm.

[0024] The locking mechanism of the grasping device includes a link member that connects the control member of the grasping device to the grasping device arm and a lock member that is fixedly attached to the housing portion. The link member is configured to engage with the lock member to releasably lock the grasping device arm. The link member can be connected to the grasping device arm at a position on the tip side of the rotation center of the grasping device arm, for example, at the end of the lever portion or towards the end thereof. The link member may include a first locking portion, and the locking member may include a second locking portion. The first locking portion and the second locking portion are configured to be complementary or to fit together so that the link member can engage with the locking member.

[0025] The link member is used to transmit control input from the gripping device's control member to the gripping device arm and to enable a releaseable lock of the gripping device arm when it is in the closed position. The link member may be located within a groove or channel. The link member may be constrained by the groove or channel so that its movement is within a desired plane of motion.

[0026] The locking member is used to selectively prevent the movement of the link member. The locking member is fixed to the housing so that the link member and the gripping device arm cannot move relative to the housing when the link member engages with the locking member. In other words, the gripping device arm remains locked in place. The locking member may include a large rack and a small rack. The large rack may be fixed to the housing. The small rack may be fixed to the large rack. The small rack may define or include a second locking portion.

[0027] Alternatively, the locking member may be fixed to the housing and have a single structure that defines or constitutes a second locking portion. The locking member may define an opening configured to facilitate connection of the base end of the housing portion to the tip end of the housing portion. The opening can facilitate hinge connection.

[0028] The locking member may be equipped with a ratchet gear rack, and the link member may be equipped with a projection configured to engage with the ratchet gear rack. In other words, the locking mechanism of the gripping device may be a ratchet gear rack mechanism. A ratchet gear rack generally comprises multiple toothed members or projections. The ratchet gear rack extends along the surface of the locking member. The projection extends from the link member and may be a toothed member. The projection is complementary to the ratchet gear rack. The link member may function as a pawl. That is, the projection may be configured to prevent or prevent the reverse movement of the link member when the link member engages with the ratchet gear rack.

[0029] The ratchet gear rack may be configured to prevent the link member from moving the gripping device arm from a closed position to an open position, or from moving it between a closed position and an open position. The link member may be configured to engage with a locking member at multiple positions. Each position can control the separation of the gripping device arm from the housing when it is in the closed position. For example, each step or toothed member within a ratchet gear rack can define the position or spacing of the gripping device arms relative to the housing. Thus, the spacing of the gripping device arms relative to the housing can be controlled by the way or position in which the link member engages with the locking member.

[0030] The link member may have multiple protrusions. By providing multiple protrusions, the link member can engage with the locking member more easily. Therefore, since there are multiple stable positions for the link member to engage with the locking member, providing multiple protrusions can improve the control resolution of the locking mechanism of the gripping device.

[0031] Multiple projections on the link member may be configured to engage simultaneously with the locking member. By providing multiple projections configured to engage simultaneously with the locking member, the link member may be configured to engage the locking member with multiple projections. This can increase the locking force of the locking mechanism of the gripping device. In some configurations, the link member may comprise a sprag or multiple sprags. The locking member may define a race. The locking mechanism of the gripping device may therefore comprise a sprag clutch mechanism.

[0032] One or more sprags may be configured to engage with the race. Depending on the shape of each of the sprags, when one or more sprags engage with the race, the link member can prevent the gripping device arm from moving from a closed position to an open position. The sprag may be subject to reverse-reverse protection or may be prevented from reversing by a race. In this configuration, it is preferable that the link member is fixed to the control member of the gripping device. That is, the link member is fixed to the control member of the gripping device so as not to move. In this configuration, the link member may be formed integrally with the locking member of the gripping device.

[0033] The position in which one or more sprags engage with the race can control the position or separation from the housing portion to which the gripping device arm is locked when in the closed position. The materials of one or more sprags and laces may be selected to obtain the desired locking force. For example, one or more sprags and laces may be made of steel. Alternatively, the laces may be lined with a high-friction material such as polymer, rubber, or rubber composite material. Sprags may also be made from high-friction materials such as polymers, rubber, or rubber composites. One or more sprags and / or races may be made of steel and may be coated within one or more layers of the aforementioned high-friction materials.

[0034] The link member may comprise a first end connected to the gripping device arm and a second end connected to the control member of the gripping device. The link member may be a separate component from the control member of the gripping device, or the link member may be formed integrally with the control member of the gripping device, i.e., as part of the control member of the gripping device. The first end of the link member is generally preferably movably connected to the gripping device arm and rotatably connected to the gripping device arm. The gripping device arm may have a pin or projection, and the first end of the link member may have an opening. The opening may be configured to receive a pin.

[0035] The control member of the gripping device may include a joint member. The joint member may be located at the tip of the control member of the gripping device. A link member can be coupled to the control wire of the gripping device via the joint member. The joint member may be an integral part of the control member of the gripping device, or it may be a separate part fixed to or attached to the control member of the gripping device. The first end of the link member may be rotatably connected to the gripping device arm, and the second end of the link member may be rotatably connected to the control member of the gripping device.

[0036] The joint member may have an opening, and the second end may also have an opening. Each opening may be connected via a pin extending through the opening. Alternatively, the second end of the link member may be rotatably coupled to the joint member via a hinge joint. The second end of the link member may define a socket or cup configured to receive a cylindrical member of the joint member. The cylindrical member may be configured to engage with the link member via a snap-fit ​​engagement or any other suitable mechanism to facilitate rotational coupling.

[0037] The locking mechanism of the gripping device may include a contact portion. The contact portion is configured to prevent the first end of the link member from crossing the axis extending between the second end of the link member and the rotation center of the gripping device arm when the gripping device arm moves between a closed and an open position. The contact portion can define the maximum distance between the gripping device arm and the housing portion, i.e., the widest position. In other words, the contact portion can limit the range of motion of the gripping device arm.

[0038] By providing a contact portion, it is possible to prevent the gripping device arm from extending excessively. If the gripping device arm extends excessively, there is a risk that the gripping device arm will lock out in the open position. Therefore, by providing a contact portion, the gripping device arm can move more smoothly between the closed and open positions. The contact portion may be a projection extending from the first end of the link member, and the projection is configured to contact the shoulder region of the gripping device arm when the gripping device arm is in an open position.

[0039] The contact portion is formed on or attached to a link member and moves with the link member. The shoulder region is close to the first end of the link member and is preferably formed on the surface of the lever portion of the gripping device arm. The contact portion is configured to engage with the shoulder region when the gripping device arm is in its most open position in the open configuration. The contact portion may be a support column located within the housing portion, and the support column is configured to contact the link member when the gripping device arm is in the open position.

[0040] The contact portion is fixed to the link member. The support column may extend between opposing surfaces within the housing portion, or it may be a projection formed on or fixed to each surface of the housing portion. The link member is configured to engage with the support column when the gripping device arm is in its most open position in the open configuration. In other configurations, the contact portion may be a projection extending from the second end of the link member. The contact portion may be configured to contact the joint member or engagement surface of the control member of the gripping device when the gripping device arm is in the open configuration.

[0041] In other configurations, the link member may be formed integrally with the control member of the gripping device. The link member may be rotatable relative to the control member of the gripping device via an elastic joint or spring mechanism. The link member may be biased to deform toward the gripping arm, that is, to deform away from the axis extending between the second end of the link member and the center of rotation of the gripping arm when the gripping arm moves between the closed and open configurations. This prevents the link member from stretching excessively.

[0042] Alternatively, the first end of the link member may be rotatably coupled to the gripping device arm, or the second end of the link member may be fixed to the control member of the gripping device. The link member is fixed to the control member of the gripping device so as not to move relative to the control member of the gripping device. The link member may be formed integrally with the control member of the gripping device. Alternatively, the link member may be fixedly coupled to the control member of the gripping device, for example, by adhesive or welding. The link member may include a socket or recess configured to receive a wire guide member.

[0043] The first end of the link member may have an opening that is rotatably connected to a pin of the gripping device arm, with a gap between the pin and the opening. The opening is wider than the pin, and a clear gap or void exists between the pin and the opening. Thus, the link member is configured to transmit the control input from the control member of the gripping device to the gripping device arm with a certain amount of play or backlash.

[0044] By providing a gap between the opening itself and the pin, smoother control of the link member can be achieved when engaging with the locking member. The pin may be equipped with a cap or fixing portion to prevent the link member from disengaging from the gripping device arm.

[0045] In some configurations, the locking member may comprise a first rack portion and a second rack portion. The second rack portion may comprise or define a second locking portion, and the first rack portion may be fixed to the housing portion. The second rack portion may be connected to the first rack portion by an elastic mechanism. The elastic mechanism may elastically bias the second rack portion toward the base end or so as to readily engage with the link member.

[0046] The locking member may be configured to deform when force is applied by the control member of the gripping device. The link member may slide along the locking member or move relative to the locking member when the locking member is deformed. Such a mechanism allows for smoother control of the link member when engaged with the control mechanism of the gripping device. In some configurations, the link member may include a spring member extending from the link member, and the first locking portion is located at the end of the spring member.

[0047] The first end of the spring member may be fixed to the link member. The first locking portion may be located on or at the second end of the spring member, the second end of the spring member being opposite to the first end. By providing the first locking portion at the end of the spring member, it is possible to introduce elasticity to the extent that allows the first locking portion to easily engage with the second locking portion.

[0048] The second end of the spring member may be movably connected to the link member. The second end of the spring member may be connected to the link member by, for example, a hinge joint. By movably connecting the second end of the spring member to the link member, additional support can be provided to the first locking portion located at the end of the spring member, while also providing elasticity to the first locking portion. The anchor system deployment mechanism may be configured to hold and / or guide the anchor system during deployment into soft tissue. The anchor system deployment mechanism may include an anchor deployment tube that holds and guides a portion of the anchor system.

[0049] The anchor system deployment mechanism may be configured to deploy the anchor system from the anchor system deployment mechanism in a direction extending from the proximal end of the catheter device toward the tip of the catheter device. The catheter device may include a linear rod for deploying the anchor system from an anchor system deployment mechanism.

[0050] The catheter device may be equipped with an anchor system, which is located within an anchor system deployment mechanism. The anchor system deployment mechanism may define an anchor system tube. The anchor system may be configured to deploy from the anchor system tube. The opening of the anchor system deployment mechanism may be provided with an opening in which the anchor system is deployed by being pushed out from an opening at the end of the anchor system tube. The opening is positioned to come into contact with soft tissue during deployment.

[0051] The anchor system is preferably a soft tissue anchor system, that is, an anchor system for implantation in soft tissue. The soft tissue anchoring system may comprise a U-shaped fabric body having a base and at least two arm portions extending from the base, each arm portion being configured to fold toward the base, so that when in use, the soft tissue is sandwiched between the base and each of the arm portions.

[0052] By providing a fabric body that includes two or more arm portions extending from the same base, the anchor system can come into contact with a larger surface area of ​​body tissue when implanted, thus improving stability and / or tissue growth during implantation. Furthermore, by providing a foldable arm portion attached via the base, the base itself can provide an even larger surface area for connecting the anchor system and the valve leaflets during implantation. A U-shaped anchor system, i.e., an anchor system having at least two arm portions, may offer improved performance compared to a single arm portion.

[0053] Therefore, the soft tissue anchoring system described above may offer improved anchoring strength compared to known anchoring systems that have a single arm and / or fixing member and / or use different design features. Furthermore, the use of a fabric body compared to a rigid body such as a metal body can reduce the damage to body tissue caused by the anchor during and / or after implantation. The fabric body better complements the surface of the body tissue it contacts, and therefore spreads the force exerted on the body tissue over a wider area, reducing the trauma suffered by the body tissue at the implantation site.

[0054] The folding of the arm portion towards the base can be thought of as a bellows motion. Therefore, the arm portion may also be configured to meander towards the base so that body tissue is trapped between the base and the arm portion during use. The fabric body, formed from a woven material, may be arranged to fold or bellows naturally due to the adaptability of the woven material. However, in some configurations, the arm portion may include folding lines, constricted portions, and / or weakened portions configured to assist in the folding and / or bellowing of the arm portion.

[0055] In one configuration, each arm can be configured to fold toward the base due to the action of tension lines passing through the arm and the base. When two arm sections are used, each arm can have its own tension line. Thus, the tension lines can be advantageously configured to fold the arm toward the base when a tensile force is applied to the tension line. It will be understood that each tension line can act as an embedded string (i.e., the tension line can be an artificial chordal line).

[0056] The tension wire is preferably fixed to the arm at the end of the arm closer to the tip than the base. Therefore, when tension is applied to the tension wire, the entire arm may be configured to fold toward the base. The position through which the tension wire passes can sometimes facilitate the folding of the arm. For example, when the tension wire is pulled, it may also pull on the hole in the arm through which the tension wire passes. This biases the arm to fold depending on the position of the tension wire in the arm.

[0057] The anchor system is preferably configured so that tension is applied to a portion of the tension line passing through the base. This configuration facilitates the overall folding of the arm. The arm and base can accommodate tension wires up to three or four times. This configuration allows for wider spacing between the holes in the fabric body through which the tension wires pass, or for shortening the fabric body itself. Compared to the anchor size, each of these configurations provides a wider folded portion of the fabric body, improving the stability of the anchor system during implantation. Using a shorter fabric body may also reduce the overall size of the soft tissue anchor system, thus improving its packaging within the delivery device / system for implantation.

[0058] The soft tissue anchoring system may include artificial chordae tendineae. That is, the fabric body may be combined with artificial chordae tendineae. The artificial chordae tendineae may be fixedly joined to the tension lines so that the relative position between the tension lines and the artificial chordae tendineae does not change. Artificial chordae tendineae may be slidably joined to a portion of the tension line passing through the base. The artificial chordae tendineae may be positioned to apply tension to the tension line.

[0059] Alternatively, the artificial chordae tendineae may be slidably joined to the tension lines by any suitable knot, such as a restraining knot. Or, the artificial chordae tendineae may be slidably joined to the tension lines by an intermediate member, such as an eyelet, through which the tension lines pass and which is connected to the artificial chordae tendineae. Artificial chordae tendineae may be joined to the fabric body via their bases using any suitable fastening configuration.

[0060] Tension lines and / or artificial chordal lines may be formed from suture material. Each arm section is equipped with an end cap fixed to the tip end of each arm section relative to the base, and each end cap has an opening configured to engage with a wire guide member, thereby embedding a U-shaped fabric body within the soft tissue. By providing an end cap with an opening configured to engage with a wire guide member for embedding the fabric body, the arm can be manipulated so that it is embedded through body tissue. For example, the wire guide member can push the arm in the engagement direction so that it passes through body tissue.

[0061] Furthermore, by using a wire guide member to guide the arm through body tissue instead of a needle through which the arm extends, the hole in the body tissue through which each arm passes does not need to be as large as the hole required for the needle or other conduit through which the arm passes. In other words, the size of the opening is constrained solely by the geometric shape of the fabric body. In contrast, the size of the opening required for implantation via a needle is always constrained by the size of the needle, which is always larger than the member being deployed. This can reduce trauma at the implantation site.

[0062] The catheter device may include a wire guide member for deploying the soft tissue anchor system. The anchor system may include tension lines (for example, as described above). The tension lines may be fixed to the end cap or extend from its central portion, and in use, the end cap is configured to extend in a plane parallel to the surface of the body tissue when embedded in soft tissue and to extend under the tension of the tension lines as it passes through the tissue in a direction away from the surface.

[0063] Each end cap may have a pointed tip. The pointed tip may be configured to perforate body tissue; for example, the pointed tip may perforate body tissue when power is applied to the end cap by a wire guide member. The tip of the end cap may be located at the end of the end cap on the tip side of the arm portion (i.e., the end on the tip side of the opening configured to engage with the wire guide member).

[0064] Each end cap may comprise an outer tubular member and an inner tubular member, the inner tubular member being configured to be received by the outer tubular member. That is, the inner tubular member may be nested within the outer tubular member and / or concentric with the outer tubular member. The inner tubular member may define an opening configured to engage with a wire guide member. The outer and inner tubular members may be configured to sandwich, crimp, and / or clamp the tip of the arm portion, thereby securing the end cap to the arm portion. Adhesive may be used additionally or as an alternative to secure the end cap to the arm portion.

[0065] The inner tubular member may have a flared inlet that defines an opening configured to engage with a wire guide member. The flared inlet is understood to be part of the inner tubular member defining the opening, and the circumferential length of the inner tubular member is understood to be longer than the rest of the inner tubular member. The flared opening can be configured to fit with a corresponding portion of the wire guide member. That is, the flared opening may be complementary in shape to the shoulder region, i.e., the protruding portion, of the wire guide member to be drilled. The flared inlet's inclined surface may be complementary to the shoulder region, i.e., the bulge, of the wire guide member. The flared inlet improves contact between the wire guide member and the end cap when the fabric body is embedded.

[0066] The outer tubular member may have a pointed tip. The inner tubular member may have a blind hole for receiving a wire guide member. The tension wires can be secured to end caps. Each end cap can be configured to receive the tension wires between the inner and outer tubular members. The tension wires can be secured to each end cap by crimping, swaging, clamping, bonding, and / or by sandwiching the tension wires between the inner and outer tubular members. The tension wires can also be secured by sewing or by tying them to the tubular members.

[0067] The outer tubular member may have an opening formed in its side wall, which is configured to receive tension lines. The opening may be formed in the central region of the end cap, and more preferably, the opening may be formed toward the tip of the end cap. Each end cap may be configured to extend collinearly with the respective arm portion while embedded in and / or pulled out of the U-shaped fabric body. Each end cap may be configured to extend parallel to the plane of each fold of the respective arm portion when a tensile force is applied to the tension line.

[0068] The arm portion may be fixed to the end of the end cap on the base end side of the arm portion, and the tension wire may be fixed toward the central region and / or tip of the end cap on the tip side of the arm portion, so that the tension applied by the arm portion and / or tension wire can generate torque in the end cap.

[0069] Therefore, when the wire guide member engages with the end cap, the end cap straightens and extends substantially in line with the arm. This facilitates the embedding of the arm of the fabric body into body tissue. When the tension wire is subjected to tensile force and thus the arm is folded, the tension wire may rotate the end cap parallel to the folding of the arm and therefore parallel to the surface of the body tissue into which the arm is folded. This facilitates the fixation of the arm to the body tissue and minimizes the protrusion of the end cap from the body tissue during embedding. For example, the end cap rotates in a "T" shape perpendicular to the tension line, so that the tension line is perpendicular to the surface of the tissue and the length of the end cap is parallel to the surface of the tissue, thereby preventing the end cap from passing through the tissue.

[0070] The wire guide member may be the linear rod. Alternatively, the soft tissue anchoring system may include an anchor having a folded position and an unfolded position, comprising a plurality of hooks for engaging with soft tissue, the anchor being made of an elastic material and being able to be elastically deformed into the folded position by the application of a restraining force and returning to the unfolded position when no restraining force is applied. Anchors having a hook structure may be valve leaflet anchors as described in International Publication No. 2016 / 042022 or International Publication No. 2020 / 109596.

[0071] The gripping device may have multiple serrated sections for gripping soft tissue. The gripping device arm itself may have one or more serrated sections. The serrated teeth can be positioned on a first portion of the gripping device arm configured to face the opening of the anchor system deployment mechanism, and on a second portion of the gripping device arm configured to face the housing portion.

[0072] The serrated portion can increase the contact area between the soft tissue and the gripping device. Therefore, by providing a serrated portion surrounding the gripping device in this way, the gripping device can provide improved gripping contact between itself and the soft tissue. For example, the serrations can effectively surround the surface of the gripping device arm configured to contact the soft tissue in a circumferential direction. Thus, the soft tissue can be better supported by the gripping device when gripped.

[0073] Furthermore, the housing portion may include a plurality of serrated portions formed on its surface and configured to face the gripping device arm. Providing serrated portions on both the gripping device arm and the housing can further improve the gripping force of the gripping device arm on the valve leaflet. The serrated portion is preferably blunted to minimize trauma to soft tissue when grasped. The serrated portion may be unevenly and / or uniformly distributed teeth on the surface of the grasping device arm and / or the housing of the catheter device. The serrated portion increases its surface area compared to, for example, a flat surface. The gripping device may include an internal space configured to receive the anchor system during its deployment. The internal space may be formed within the gripping device arm.

[0074] The internal space may be configured to receive the arm portion and / or end cap and wire guide member deployed from the anchor system deployment mechanism. The internal space is open to the surface of the gripping device arm configured to contact soft tissue and is bounded by the side walls of the gripping device arm. The internal space facilitates the complete extension of anchor deployment members such as straight rods and wire guide members, and allows the arm portion and / or end cap to fully pass through the valve leaflet, or the hook forming portion to fully pass through the valve leaflet, thereby ensuring secure embedding in soft tissue.

[0075] The internal space may comprise a first internal space configured to receive a first wire guide member or a first hook forming portion, and a second internal space configured to receive a second wire guide member or a second hook forming portion. The openings of the first and second internal spaces may be separated by gripping portions configured to contact the valve leaflets. Providing gripping portions increases the surface area of ​​the soft tissue in contact with the gripping device arms, thereby improving the stability of the soft tissue when embedding multiple arm portions and / or end caps or hook forming portions into the soft tissue.

[0076] The anchor system deployment mechanism, or another part of the catheter device holding the anchor deployment mechanism, can be configured to remove the wire guide member and / or apply tension to the tension wire to position the arm and / or end cap in the final position, where, for example, the arm is folded and / or the end cap rotates to align with the surface of the body tissue.

[0077] The anchor system may be held within a curtain or sheath in the catheter device, for example, within the anchor system deployment mechanism. The sheath may be configured to deflect or collapse during deployment to assist in the deployment of the anchor system, particularly the deployment of soft tissue anchor systems having a fabric body from the catheter device. The sheath can reduce friction between the anchor system and the catheter device during the deployment of the anchor system from the catheter device.

[0078] The sheath may be a thin, tubular sheath. If the anchor system includes a fabric body, a sheath can be used to hold the fabric body. If the anchor system includes a tubular cap member / end cap, the tubular cap member / cap may be held outside or inside the sheath. The sheath may be housed within the anchor system deployment mechanism.

[0079] The sheath may be attached to or secured to the anchor system deployment mechanism so as not to be released from the catheter device during deployment of the anchor system from the catheter device. The anchor deployment mechanism may include an anchor deployment tube that holds and guides parts of the anchor system, such as an arm section and / or end cap, and a wire guide member or hook forming section.

[0080] When a U-shaped fabric body and multiple arm sections, such as two arm sections, are used, or when a hook structure is used, the anchor deployment tube may comprise a pair of tubes, one for each arm section and its corresponding wire guide member or hook forming section, and the joint between the tubes allows a connecting bridge of the fabric from the base between the arm sections to be stretched between the tubes, or the base of an anchor having a hook forming section to be stretched between the tubes. For example, there may be slots along the tube for the connecting bridge or base to slide.

[0081] The sheath may be held within the anchor deployment tube, or it may extend to a tube housing the end cap / hook forming portion. The anchoring system may be a leaflet anchoring system, the soft tissue is the heart valve leaflet, and the catheter device is for implanting the leaflet anchoring system into the heart valve leaflet to fix the artificial chordae tendineae. The anchor system deployment mechanism may be configured to implant the valve leaflet anchor system into the cardiac valve leaflet by perforating the leaflet from the atrial side. The valve leaflet may be a mitral valve leaflet or a tricuspid valve leaflet.

[0082] Previous catheter devices, as described in International Publication Nos. 2016 / 042022 and 2020 / 109596, generally aimed to implant a leaflet anchor system into the heart valve leaflet by perforating the leaflet from the ventricular side rather than the atrial side. However, this application recognizes that catheter devices implanting the leaflet anchor system from the atrial side of the leaflet offer many advantages, which are not present when the leaflet anchor system is implanted from the ventricular side of the heart valve leaflet.

[0083] When implanted from the ventricular side of the valve leaflet, the leaflet anchor system may need to be positioned toward the edge of the leaflet to provide sufficient support to the leaflet. In contrast, when implanted from the atrial side of the valve leaflet, the leaflet anchor system may provide adequate support to the leaflet edge when implanted toward the leaflet edge or toward the annulus of the leaflet.

[0084] The choice of implantation site for leaflet anchors can depend on several factors and may be patient-specific. By implanting the leaflet anchor system on the atrial side of the leaflet, surgeons can choose where to implant the leaflet anchors more flexibly. Specifically, they can implant the leaflet anchors at the edge of the leaflet, in the annulus of the leaflet, or between the edge and the annulus, thus offering greater flexibility.

[0085] Tissues closer to the valve annulus, rather than those closer to the edges of the valve leaflets, may be less susceptible to trauma related to the implantation of valve leaflet anchors. For example, the tissue near the valve annulus may be thicker than the tissue near the valve margin. The tissue near the valve annulus has a higher capacity to withstand the tension associated with artificial chordae tendineae when they are under tension during the heart cycle. By implanting the leaflet anchor system from the atrial side, it is possible to implant the system closer to the annulus of the heart's valve leaflets while still providing sufficient support to the edges of the leaflets.

[0086] When artificial chordae tendineae are used to prevent regurgitation of the valve leaflets (mitral regurgitation or tricuspid regurgitation), the chordae tendineae are usually fixed at two ends, one end located in the papillary muscle of the heart and the other end located in the valve leaflet anchoring system. Therefore, when a valve leaflet anchor system is implanted into the valve leaflet from the ventricular side, the chordae tendineae extend to the papillary muscle without providing any support to the end of the valve leaflet, that is, the end of the leaflet that is swaying. However, when the leaflet anchor system is implanted into the leaflet from the atrial side, the chordae tendineae may extend along the atrial surface of the leaflet and, before descending into the ventricle, may extend beyond the edge of the leaflet to the implantation site within the papillary muscle. Thus, by implanting anchors near the valve annulus, these chordae tendineae can support the oscillating edges of the valve. Furthermore, it may be possible to better replicate the function of the chordae tendineae located near the edges of the valve leaflets of the heart valve.

[0087] The leaflet anchoring system is positioned to be deployed, and artificial chordae tendineae may be in contact with the atrial side of the heart valve leaflet between the leaflet anchor and the edge of the heart valve leaflet. If a leaflet anchoring system is implanted from the atrial side, it can be understood that when artificial chordae tendineae are implanted, they can provide support to the wobbly edges of the leaflet when implanted on the atrial side, considering that they descend from the atrial side through the leaflet beyond its edges to the ventricular side. This may be particularly beneficial when treating wobbly leaflets.

[0088] The conventional catheter devices described in International Publication Nos. 2016 / 042022 and International Publication Nos. 2020 / 109596 generally require the precise implantation of a valve leaflet anchor system within the valve leaflet to provide sufficient support to the edges of the valve leaflets. Since a valve leaflet anchor system does not provide any further support to the edge of the valve leaflet other than the embedding of the anchor system itself, the amount of support provided to the edge of the valve leaflet is determined by the embedding position of the anchor. Therefore, the embedding of the valve leaflet anchor system may need to be more precise to ensure proper support for the edges of the valve leaflets.

[0089] However, when the leaflet anchor system is implanted on the atrial side of the leaflet, the artificial chordae tendineae come into contact with the edge of the leaflet, providing further support to the edge of the leaflet regardless of whether the leaflet anchor system is implanted toward the edge of the leaflet or toward the atrial annulus of the leaflet. Therefore, the implantation position of the leaflet anchor system of the present invention does not need to be so precise. This means that while the implantation position of the leaflet anchor may change due to leaflet movement during the heart cycle, the negative impact on the overall support provided by the leaflet anchor may be reduced, potentially leading to more efficient implantation of the leaflet anchor system.

[0090] The aforementioned anchor system tube may also be a leaflet anchor system tube. The opening of the leaflet anchor system tube may be positioned to contact the atrial side of the heart's valve leaflet during deployment. By positioning the opening of the valve leaflet anchor system tube in contact with the atrial side of the heart's valve leaflet during deployment, the implantation of the valve leaflet anchor system from the atrial side of the leaflet can be facilitated. For example, positioning the opening in contact with the atrial side ensures proper placement, positioning, and deployment of the anchor system.

[0091] The valve leaflet anchor system may be configured to be pushed out from the valve leaflet anchor system deployment mechanism from the proximal end of the catheter device toward the tip of the catheter device. The catheter device may include the aforementioned linear rod for deploying the leaflet anchor system. The linear rod may be configured to push the leaflet anchor system out of the leaflet anchor system deployment mechanism. The linear rod may also be the wire guide member.

[0092] The catheter device may include a housing portion consisting of two parts that extend from the proximal end of the catheter device toward the tip of the catheter device along the length of the catheter device. The housing portion may consist of two parts. The two-part housing portion may include a proximal end of the catheter device and a distal end located on the distal side of the proximal end. The gripping device, the control member of the gripping device, and the first anchor system deployment mechanism may be located at the proximal end of the two-part housing portion, the first anchor system deployment mechanism being an anchor system deployment mechanism, and the distal end of the two-part housing portion may include a second anchor system deployment mechanism configured to deploy the second anchor system into further soft tissue by moving the second anchor system outward in the distal direction relative to the distal end.

[0093] The two-part housing may be configured to be positioned simultaneously between the papillary muscle and the cardiac valve leaflet during use of the catheter device. The gripping device arm may be provided at the base end of the two-part housing and may be rotatably coupled to the catheter device. The gripping device arm may be rotatably coupled via any of the mechanisms described above.

[0094] The two-part housing can be formed from two tubular sections of any suitable material, i.e., a medically appropriate material. Stainless steel or Nitinol may be used for the two-part housing. Alternatively, composite materials such as carbon fiber or glass fiber reinforced PEEK can be used. Catheter devices can be formed by such combinations of materials, and the materials of different parts of the device are selected according to the required characteristics of those parts. A material that allows ultrasound to pass through while simultaneously possessing sufficient strength is preferred. Carbon-reinforced PEEK fully meets these requirements and also allows for injection molding of its components, thereby reducing manufacturing costs. Fiber-reinforced plastics are typically invisible on X-rays. Therefore, strategically placed radiopaque markers on all components can be used to determine the relative positions and orientations of catheter device components on X-rays, serving as supplementary information to ultrasound images.

[0095] A flexible joint may be positioned between the base and tip of the housing portion of the two parts. The flexible joint allows the centerline of the tip to be angled relative to the centerline of the base. The flexible joint includes a hinge element, where, for example, the tip of a two-part housing is connected to the base via a pivot mechanism or an elastically deformable element. For example, the two parts of the housing may be a composite or metal part joined together by the hinge element.

[0096] The first anchor system may be a leaflet anchor system, where the soft tissue is the heart valve leaflet, and the second anchor system may be a papillary muscle anchor system, where the further soft tissue is the papillary muscle. Thus, the first anchor system deployment mechanism may be a leaflet anchor system deployment mechanism, and the second anchor system may be a papillary muscle anchor system deployment mechanism. The catheter device may be for repairing the heart by implanting the leaflet anchor system and the papillary muscle anchor system to fix artificial chordae tendineae. The leaflet anchor system may be either the soft tissue anchor system or the leaflet anchor system described above.

[0097] The papillary muscle anchor system can be housed within the tip of the housing before deployment. The papillary muscle anchor system may have a cross-section similar to that of the tip of the housing. For example, both may have a tubular shape when the anchor system is held at the tip. As described above, the anchor system comprises an anchor having a folding configuration and an unfolding configuration, allowing the anchor pin to form a hook within the body tissue during the deployment of the papillary muscle anchor. The papillary muscle anchor system deployment mechanism may take a form similar to that of International Publication No. 2016 / 042022 or International Publication No. 2020 / 109596.

[0098] In one example, the papillary muscle anchor deployment mechanism includes a first wire or rod for pushing the papillary muscle anchor in the tip direction relative to the tip of the two-part housing. A second wire or rod may further be present for releasing the papillary muscle anchor from the papillary muscle anchor deployment mechanism, disengaging the papillary muscle anchor from the catheter device after the papillary muscle anchor has been implanted in body tissue, i.e., the papillary muscle and / or tissue adjacent to the papillary muscle.

[0099] A papillary muscle anchor may have chordae tendineae attached to the papillary muscle anchor and may include a locking mechanism such as a locking ring as described in International Publication No. 2016 / 042022 or International Publication No. 2020 / 109596, the locking mechanism being for clamping the chordae tendineae when no force is applied to the locking mechanism. The locking ring may be elastically deformable to release the chordae tendineae from the locking mechanism for adjustment of the length of the chordae tendineae. The papillary muscle anchor system deployment mechanism may include a locking ring holder for holding the locking ring in its elastically deformed position, and the papillary muscle anchor system deployment mechanism may be arranged to selectively withdraw the locking ring holder from the locking ring, thereby locking the chordae tendineae in place after deployment of the papillary muscle anchor and after any necessary adjustment of the length of the chordae tendineae.

[0100] A second aspect of the present invention provides a method for using a catheter device of the first aspect for the repair of soft tissue, the method comprising the steps of: moving a gripping device from a closed position to an open position; bringing the surface of the gripping device into contact with soft tissue; moving the gripping device from an open position to a closed position to grip the soft tissue; engaging the locking mechanism of the gripping device; and deploying the anchor system into the soft tissue.

[0101] This method may include the steps of moving the gripping device arm from a closed position to an open position, bringing the surface of the gripping device arm into contact with soft tissue, and moving the gripping device arm from an open position to a closed position to grip the soft tissue between the gripping device arm and the housing. The method of the second embodiment may have one or more features corresponding to the features of the catheter apparatus of the first embodiment. Accordingly, the above description of the catheter apparatus of the first embodiment, including but not limited to all technical advantages and alternative embodiments, may be equally applicable to the method of the second embodiment. [Brief explanation of the drawing]

[0102] Herein, specific exemplary embodiments of the present invention will be described, merely as examples, with reference to the accompanying drawings. [Figure 1] This diagram shows the procedure for inserting a catheter device through the mitral valve. [Figure 2] This diagram shows the gripping of the mitral valve leaflet using a single gripping device arm. [Figure 3] This is a close-up view of the valve during the placement of valve leaflet anchors connected to artificial chordae tendineae. [Figure 4] This diagram shows the withdrawal of the treatment catheter portion of the device and the adjustment of the chordae tendineae length using an optional adjustment catheter. [Figure 5] This diagram shows the withdrawal of the catheter device after a valve leaflet anchor has been implanted into the atrial surface of the valve leaflet. [Figure 6] This diagram shows a catheter device positioned to implant valve leaflet anchors into the atrial surface of the valve leaflets of the heart valve. [Figure 7] This diagram shows the fabric body anchor system. [Figure 8] This is a detailed diagram of the end cap of the fabric body anchor system. [Figure 9A] This figure shows the fabric body anchor system being embedded into the mitral valve leaflets. [Figure 9B] This diagram shows the fabric anchor system after implantation into the mitral valve leaflet, viewed from a lateral ventricular view. [Figure 10A] This figure shows an alternative end cap arrangement for the fabric body anchor system being embedded in the mitral valve leaflet. [Figure 10B] Figure 10A is a detailed diagram showing the arrangement of the end caps of the fabric body anchor system. [Figure 11A] These are various schematic diagrams of soft tissue anchor systems housed within the delivery shaft of a catheter device. [Figure 11B] These are various schematic diagrams of soft tissue anchor systems housed within the delivery shaft of a catheter device. [Figure 11C] These are various schematic diagrams of soft tissue anchor systems housed within the delivery shaft of a catheter device. [Figure 12] This is a cross-sectional view of the proximal end of the catheter device housing. [Figure 13] This is a cross-sectional view of the housing of the gripping device for a catheter device. [Figure 14A] This is a perspective view of the locking mechanism of the gripping device. [Figure 14B] The exploded view shows the components of the locking mechanism of the gripping device. [Figure 14C] The exploded view shows the components of the locking mechanism of the gripping device. [Figure 15A] Figure 14 is a cross-sectional view of a modified example of the locking mechanism of the gripping device. [Figure 15B] Figure 14 is a cross-sectional view of a modified example of the locking mechanism of the gripping device. [Figure 16] This is a cross-sectional view of the locking mechanism of a gripping device that serves as an alternative to a catheter device. [Figure 17A] This is a cross-sectional view of the locking mechanism of a gripping device that serves as an alternative to a catheter device. [Figure 17B] This figure shows a more detailed modified configuration of the locking mechanism of the gripping device shown in Figure 17A. [Figure 17C] This figure shows a more detailed modified configuration of the locking mechanism of the gripping device shown in Figure 17A. [Figure 17D] This figure shows a more detailed modified configuration of the locking mechanism of the gripping device shown in Figure 17A. [Figure 17E] This figure shows a more detailed modified configuration of the locking mechanism of the gripping device shown in Figure 17A. [Figure 18] Cross-sectional view of the locking mechanism of an alternative grasping device for catheter devices. [Figure 19A] This is a cross-sectional view of the locking mechanism of a gripping device that serves as an alternative to a catheter device. [Figure 19B] Figure 19A shows the modified link member of the locking mechanism of the gripping device. [Modes for carrying out the invention]

[0103] The following description details one or more features of the catheter apparatus of the present invention that are consistent with and can be combined with the preceding description. The following embodiments discussed herein should not be viewed in isolation, nor are they intended to be limiting, but should be viewed in the context of the whole of this disclosure, with reference to the accompanying drawings.

[0104] The catheter device shown here is proposed for non-surgical (intravascular) insertion of the chordae tendineae of the mitral valve to address mitral regurgitation caused by prolapse of the mitral valve leaflet 12. The drawings show different forms of catheter devices 2 for this purpose, but it will be understood that the general principle for inserting one or more artificial chordae tendineae 14 into the heart with respect to the implantation of leaflet anchors 10 and papillary muscle anchors 9 is the same for each device. The artificial chordae tendineae 14 are fixed to the prolapsed leaflets 12 and papillary muscles 26, thereby recreating the normal anatomical structure. Both the leaflet anchors 10 and papillary muscle anchors 9 are positioned using a single catheter device 2. The length of the chordae tendineae 14 can be adjusted using the same catheter device 2 to eliminate mitral regurgitation. Thus, such catheter devices enable a single minimally invasive endovascular procedure used to repair the mitral valve, offering significant advantages compared to previous systems that required more invasive procedures and / or multiple operations.

[0105] An endovascular approach is preferred, and therefore the device can be used with this approach; however, it should be noted that the device may be used in different procedures, including more invasive ones. Many advantages remain, and it may be beneficial to use the device in situations where a more invasive procedure is advantageous. In addition, as stated above, the catheter device of the present invention may be used for purposes other than the treatment of mitral regurgitation, and this disclosure is not limited in this respect.

[0106] The catheter device 2 described below can be used to insert the chordae tendineae of the mitral valve through the venous system, starting from the femoral vein in the groin. The catheter is then advanced to the right atrium. Next, the left atrium is accessed via a so-called transatrial septal puncture, after which a larger guiding catheter is advanced into the left atrium. Subsequently, catheter device 2 for cardiac repair is introduced into the left atrium through the guiding catheter.

[0107] Using X-ray and ultrasound guidance, the catheter device is positioned and the mitral valve leaflets 12 are grasped, and artificial chordae tendineae 14 are attached using leaflet anchors 10, as described in more detail below. The artificial chordae tendineae 14 are then attached to the papillary muscles 26 using papillary muscle anchors 9. Here, the length of the chordae tendineae may be adjusted to eliminate any mitral regurgitation. Next, any excess chordae tendineae are cut, and the entire catheter is withdrawn. Ultrasonography and Doppler imaging are used to perform the procedure and monitor the results. Successful use of this endovascular technique will dramatically reduce the invasiveness, complications, and costs of mitral valve repair.

[0108] Further details regarding the structure and function of the catheter device are described below with reference to the drawings. The procedure for using one form of the device can be summarized as follows. 1) Using the standard Seldinger technique, insert the femoral vein and introduce the guiding catheter. 2) The guiding catheter is advanced to the right atrium under X-ray guidance. 3) After penetrating the atrial septum, it is guided by X-ray and transesophageal echocardiography into the left atrium. 4) The precise location of the left atrium entrance is verified to ensure proper positioning for insertion of the guiding catheter and therapeutic catheter. The entrance opening of the atrial septum is dilated, and the guiding catheter is advanced into the left atrium. 5) The treatment catheter device 2 is advanced through the guiding catheter and positioned in the left atrium above the mitral valve. 6) The prolapsed segment of the mitral valve leaflet 12 is positioned using ultrasound, the treatment catheter device 2 is advanced into the left ventricle, and the grasping device 6 of the treatment catheter device 2 is positioned to grasp the prolapsed segment. 7) After the escape segment is grasped and its correct position is ensured, the valve leaflet anchor 10 is embedded in and secured to the valve leaflet 12. 8) The connection to the valve leaflet anchor is attempted while still attached to catheter device 2, and if the connection is sufficient, the tip of the catheter is advanced further into the left ventricle. 9) The papillary muscle anchor 9 is pushed out into the papillary muscle 26 region and out of its housing 8, thereby opening the papillary muscle anchor 9 inward into the papillary muscle 26. 10) If the gripping device 6 is still gripping the valve leaflet 12, the gripping device 6 is released. 11) The length of the artificial chordae tendineae 14 is adjusted until mitral regurgitation is eliminated. 12) Withdraw catheter device 2 from papillary muscle anchor 9 and confirm the disappearance of mitral valve regurgitation again by echocardiography. 13) The artificial chordae tendineae 14 are locked in place by the papillary muscle anchors 9. 14) The extra chordae tendineae 14 are cut. 15) If necessary, additional artificial chordae tendineae may be placed. 16) The catheter device is completely withdrawn and removed from the vascular system.

[0109] Figures 1 to 6 show an exemplary catheter device 2 disclosed in International Publication No. 2020 / 109596. The catheter device 2 disclosed in International Publication No. 2020 / 109596 is used to implant a leaflet anchor 10 in combination with an artificial chordae tendineae 14 from the ventricular side of the mitral valve leaflet 12, but many of the features and / or components of the exemplary catheter device 12 may be compatible with the catheter device 102 of the present invention, or may be modified according to the teachings of the present invention so that a leaflet anchor 110 in combination with an artificial chordae tendineae 114 can be implanted into the leaflet 12 from the atrial side of the leaflet 12, as shown in Figures 5 and 6.

[0110] Figure 1 shows a guiding catheter 22 used to guide the catheter device 2 to the desired location in the heart, extending through the mitral valve and thus between the two valve leaflets 12. The catheter device 2 consists of four distinct main parts: a movable catheter, a gripping device housing 4, a gripping device 6, and a papillary muscle anchor housing 8 that holds a papillary muscle anchor 9. The gripping device housing 4 and the papillary muscle anchor housing 8 can form the proximal 4 and aproximal 8 of the two-part housing section. The movable catheter can be replaced with an alternative configuration using a maneuverable sheath around the movable catheter and flexible tubing within the maneuverable catheter. This can be replaced with an alternative configuration that uses a movable sheath around the movable catheter and a flexible tube inside the movable catheter.

[0111] Figure 1 shows a front view of an example of a catheter device with the gripping device 6 in a closed state. Some gripping devices 6 use a single gripping device arm 30 to grip the valve leaflet 12 against the gripping device housing 4. The gripping device 6 is part of a valve leaflet anchor deployment mechanism for deploying the valve leaflet anchor 10 and attaching it to the valve leaflet 12 of the heart. In the example shown, the gripping device 6 includes a valve leaflet anchor tube for housing the valve leaflet anchor 10 before deployment. When the gripping device 6 grips the valve leaflet 12, the valve leaflet anchor 10 is pushed out of the valve leaflet anchor tube, penetrates the valve leaflet 12, and can be fixed in place within the valve leaflet 12.

[0112] The valve leaflet anchor 10 is connected to an artificial chordae tendineae 14. The artificial chordae tendineae 14 enters the papillary muscle anchor housing 8, passes through the lock segment 28 of the papillary muscle anchor, and through the locking and cutting segments. The artificial chordae tendineae 14 can be attached to a wire that runs along the catheter to the outside (to make adjustments smoother). Since the wire is pushed through the catheter, the chordae tendineae can be shortened during the procedure by pulling or lengthening them. The two parts, the gripping device housing (base end) 4 and the papillary muscle anchor housing (tip end) 8, may have a diameter of approximately 6-7 mm and a length of approximately 30 mm.

[0113] Figure 2 shows the configuration of a gripping device mechanism 6 in which a single gripping device arm grips the valve leaflet 12, with the gripping device arm holding the valve leaflet 12 relative to the gripping device housing 4. A raised surface on the gripping device arm 30 may be provided to assist in gripping the valve leaflet 12. 3D ultrasound and / or other available sources may be used to verify that the gripping device mechanism 6 has gripped the correct portion of the valve leaflet 12.

[0114] The gripping device mechanism 6 can be opened and closed the number of times necessary to grip the right-side portion of the valve leaflet 12. Opening and closing is facilitated by a system in which one wire pulls the gripping device mechanism 6 to open it, and another wire pulls it to close it. Once the position of the gripping device mechanism 6 is confirmed, the valve leaflet anchor 10 can be pushed out from the end of the valve leaflet anchor tube by pulling a wire at the other end of the catheter. Figure 3 shows an enlarged view of the valve leaflet anchor 10 positioned within the valve leaflet 12.

[0115] If the physician is not satisfied with the connection during the examination (for example, if the movement of anchor 10 is too large and / or if there is not enough resistance to apply force to the chordae tendineae), the valve leaflet anchor 10 can be retracted and positioned in a different location. With the valve leaflet anchor 10 embedded in the valve leaflet 12, the papillary muscle anchor housing 8 at the end of the treatment catheter is positioned on the papillary muscle 26 (not shown).

[0116] As the tip of the tip 8 comes into contact with body tissue and further force is applied, the reaction force from the body tissue eventually exceeds the force that holds the papillary muscle anchor 9 in place. At this point, the tissue is pressed flat beneath the base of the tip 8, maximizing the likelihood that all the pins 62 of the papillary muscle anchor 9 will be correctly positioned within the tissue. Force is then applied to the papillary muscle anchor 9, causing the ends of the pins 62 to move beyond the tip of the tip 8 and come into contact with body tissue. This may be done via additional force from the rod or wire 60 to the papillary muscle anchor 9, or by extending the adjustment catheter 21, or by applying pre-tension to the papillary muscle anchor 9 (or friction between the adjustment catheter 21 and the tip 8), which is held by friction with the tip until the force of the body tissue acting on the tip 8 sufficiently changes the balance of force with friction and the papillary muscle anchor 9 pops out like a paper stapler. When the papillary muscle anchor 9 is ejected, the pin 62 folds to form a hook shape on the unrestrained papillary muscle anchor 9, thereby engaging with the body tissue 26. At this point, the connection can be tested by the operator through tensile testing and / or visually confirmed by X-ray and / or ultrasound. If the connection is insufficient, attempt to improve the connection between the papillary muscle anchor 9 and the body tissue 26 by pulling the papillary muscle anchor 9 back to the tip 8 and repositioning it.

[0117] Figure 4 shows the following steps. The main parts 4 and 8 of the adjustment catheter device are retracted to minimize their impact on the moving valve leaflet 12. The adjustment catheter 21 remains attached to the papillary muscle anchor 9. The length of the artificial chordae tendineae 14 can be adjusted using an external wire. The length is continuously adjusted and the function of the valve leaflet 12 is monitored. The length of the artificial chordae tendineae 14 can be shortened by pulling the chordae tendineae wire back through the catheter. The length can also be increased by pushing the chordae tendineae wire, which loosens the artificial chordae tendineae 14 and allows the movement of the valve leaflet 12 to pull it out from the adjustment catheter 21. The small size of the adjustment catheter 21 means that the effect of the catheter device on the function of the valve leaflet 12 is minimized. The correct length of the artificial chordae tendineae 14 is confirmed by 3D ultrasound and / or other available sources.

[0118] Once the correct length is confirmed, the catheter device is removed from the papillary muscle anchor 9. This process also locks the artificial chordae tendineae 14 in place, cuts off any excess, and retains the excess within the catheter, which is then expelled from the body when the catheter is removed. The lock segment 28 of the papillary muscle anchor 9 is held open by a cutting piece (not shown). The lock segment 28 is a band of the papillary muscle anchor 9 that can be bent to create a gap for the artificial chordae tendineae 14 to pass through. In the natural shape of the papillary muscle anchor 9, when no force is applied, this lock segment 28 fits tightly with the rest of the anchor 9, thereby holding the artificial chordae tendineae 14 in place. The lock segment 28 is held open until the artificial chordae tendineae 14 is the correct length. The cutting piece cuts the artificial chordae tendineae 14, which is pulled against the blade when the adjustment process is complete.

[0119] The catheter device 2 disclosed in International Publication No. 2016 / 042022 and International Publication No. 2020 / 109596, respectively, implants a leaflet anchor 10 from the ventricular side of the leaflet 12. As shown in Figure 4, the artificial chordae tendineae 14 thus descend from the leaflet 12 from the ventricular surface of the leaflet 12 to the papillary muscle 26. Several benefits are associated with implanting the leaflet anchor 10 or the soft tissue anchor system discussed below, and thus the artificial chordae tendineae 14, on the ventricular side of the leaflet 12, as discussed in International Publication No. 2016 / 042022 and International Publication No. 2020 / 109596, respectively.

[0120] However, there may be situations in which it is advantageous to implant a leaflet anchor 110, and therefore an artificial chordae tendineae 114, from the atrial side of the leaflet 12. For example, as shown in Figure 4, the artificial chordae tendineae 14 descends to the papillary muscle 26 without providing additional support to the edge 13 of the valve leaflet 12. When implanted from the ventricular side of the valve leaflet 12, the artificial chordae tendineae 14 does not provide additional support to the edge 13 of the valve leaflet 12. Therefore, the implanted artificial chordae tendineae 14 may not be able to replicate the action of the chordae tendineae at the edge 13 of the valve leaflet 12 with the desired accuracy.

[0121] Implanting the leaflet anchor 10 from the ventricular side of the leaflet 12 also requires more precise placement of the leaflet anchor 10. Since no additional support is provided to the edge 13 of the leaflet 12, the placement of the leaflet anchor 10 determines the extent to which the edge 13 of the leaflet 12 is supported and / or fixed by the leaflet anchor 10. In contrast, the placement of a leaflet anchor 110 implanted from the atrial side of the leaflet 12 is less precise because the artificial chordae tendineae 114 provide additional support to the edge 13 of the leaflet 12 as it passes from the atrium to the ventricle of the heart.

[0122] Figure 5 shows the withdrawal of the guiding catheter 122 and tip 108 of the catheter device 102 after the artificial chordae tendineae 114 has been implanted in the papillary muscle 26 using the papillary muscle anchor 109, and also after the artificial chordae tendineae 114 has been implanted in the cardiac valve leaflet 12 using the valve leaflet anchor 110. The adjustment catheter 121 is shown in place before its withdrawal. The length of the artificial chordae tendineae 114 can be adjusted as needed in the illustrated configuration.

[0123] Figure 5 shows a configuration similar to that shown in Figure 4, but with a leaflet anchor 110 implanted from the atrial side of the leaflet 12, rather than from the ventricular side. As seen in Figure 2, the artificial chordae tendineae 114 extends from the base of the leaflet anchor 110 and is attached toward the edge 13 of the leaflet. The artificial chordae tendineae 114 takes the shortest possible path to the papillary muscle 26 into which the other end is implanted, whether under tension or not, so that the artificial chordae tendineae 114 contacts the atrial side of the leaflet 12 and descends beyond the edge 13 of the leaflet 12. Thus, the artificial chordae tendineae 114 implanted on the atrial side of the leaflet 12 provides additional support to the edge 13 of the leaflet 12.

[0124] The artificial chordae tendineae 114 can include regions with varying cross-sectional areas along its length. By increasing the cross-sectional area of ​​the artificial chordae tendineae 114 in a particular section, the artificial chordae tendineae 114 can increase its contact area with the heart valve leaflets 12. Thus, the force applied to the valve leaflets 12 by the artificial chordae tendineae 114 can be distributed more uniformly, and any pinching of the valve leaflets 12 that the artificial chordae tendineae 114 could cause can be avoided.

[0125] The artificial chordae tendineae 114 has a flat cross-section at the proximal end of the valve leaflet 12, that is, the long axis of the cross-sectional area of ​​the artificial chordae tendineae 114 is parallel to the surface of the valve leaflet 12. In an alternative configuration, the artificial chordae tendineae 114 is formed from multiple sutures, increasing the contact area between the artificial chordae tendineae 114 and the atrial surface of the valve leaflet 12. To implant the valve leaflet anchor 110 into the heart valve leaflet 12 from the atrial side, the valve leaflet anchor deployment mechanism and the gripping device housing 106 of the catheter device 102 are positioned as shown in Figure 6.

[0126] Figure 6 shows a catheter device 102 comprising a gripping device housing 106, a gripping device arm 130, and artificial chordae tendineae 114, the artificial chordae tendineae 114 being attached to a valve leaflet anchor 110 or a soft tissue anchor system described later, and being fed through the body of the catheter device 102. In these diagrammatic examples, the leaflet anchor 110 is housed within the body of the catheter device 102 and deployed by being pushed out from a leaflet anchor tube 138 located within the body of the catheter device 102. The leaflet anchor tube 138 is functionally similar to the leaflet anchor tube described above. The leaflet anchor tube 138 is positioned within the body of the catheter device 102 so that when the leaflet 12 is grasped between the gripping device arm 130 and the body of the catheter device 102, the leaflet anchor 110 can be deployed from the leaflet anchor tube 138 toward the atrial side of the leaflet 12. Thus, the leaflet anchor 110 is deployed within the leaflet 12, as shown in Figure 5.

[0127] In the configuration shown in Figure 6, the leaflet anchor tube 138 extends in a direction along the body of the catheter device 102 or the gripping device arm 130, with the opening of the leaflet anchor tube 138 opening toward the tip of the catheter device 102. As the catheter device 102 approaches the leaflet 12 and papillary muscle 26 from above the leaflet 12, that is, as described above, approaching from the papillary muscle, i.e., the left atrium, the opening of the leaflet anchor tube 138 is positioned to align with the atrial surface of the leaflet 12, and as a result the leaflet anchor 110 is embedded in the atrial surface of the leaflet 12.

[0128] The catheter devices disclosed in International Publication No. 2016 / 042022 and International Publication No. 2020 / 109596, respectively, used a U-rod to deploy the leaflet anchor. However, catheter device 102 uses a linear rod to deploy the leaflet anchor 110. The linear rod extends from the proximal end of catheter device 102 into the leaflet anchor tube 138, and the leaflet anchor 110 can be deployed on the atrial side of the leaflet 12. The anchor system can be deployed by using the end of the linear rod located within the valve leaflet anchor tube 138 and pushing it out from an opening facing the tip of the valve leaflet anchor tube 138. The linear rod is flexible and, for example, can bend or flex when extending within the valve leaflet anchor tube 138, and can be stretched so that it can be pushed into and pulled out of the valve leaflet anchor tube 138 without elongation. The linear rod is made of a material that can be deformed to a high degree of elasticity to allow bending of the bendable portion. Suitable materials include shape memory materials, such as shape memory metals such as nitinol. Using a shape memory metal can make the linear rod more rigid, which means that force transmission with the linear rod is more efficient. Alternatively, the linear rod can be made from several types of materials to achieve the required properties.

[0129] The following features are discussed in relation to catheter device 102, which is discussed in connection with Figures 5 and 6, but the following features are discussed in connection with Figures 1 to 4, and it will be understood that they are similar to catheter device 2, as disclosed in International Publication No. 2016 / 042022 and International Publication No. 2020 / 109596, respectively. In the configurations shown in Figures 1 to 6, the leaflet anchors 10 and 110 unfold from a folded configuration to an unfolded configuration (for example, for their containment within the leaflet anchor tube). In the unfolded configuration, the hook-shaped structure 40 unfolds so that the leaflet anchor 10 is secured within the leaflet 12. These hook-shaped structures, when in a folded configuration, extend collinearly with the valve leaflet anchor tube 138 and are used to puncture the valve leaflet 12 during the implantation of the valve leaflet anchor 10.

[0130] The soft tissue anchor system 200 can be used in place of the valve leaflet anchor 10. The soft tissue anchor system 200 is shown in Figures 7 to 10. Figure 7 shows a soft tissue anchor system 200 comprising a U-shaped fabric body 201. The U-shaped fabric body 201 comprises a base 202 and two arm portions 204 extending from the base 202. A narrow waist portion 203 extends between the base 202 and each arm portion 204. A soft tissue anchor system 200 comprising multiple arm portions 204 connected by a single base 202 can increase the surface area of ​​the anchor system 200 on both sides of the body tissue when engaged with it. This can improve the stability of the anchor system 200 when embedded in body tissue.

[0131] The U-shaped fabric body 201 is used to secure artificial chordae tendineae 214, positioned toward the base 202, to body tissue. As it is a fabric body, it will be understood that the U-shaped fabric body 201 is formed primarily from a soft material. The U-shaped fabric body 201 may be functionally comparable to cotton yarn. As shown in Figure 7, the base 202 includes a shape-retaining structure 205 embedded therein, such as a nitinol wire frame. The shape-retaining structure 205 can help the base 202 maintain its shape over time and / or provide additional lateral support to body tissue when embedded. The arm portion 204 may also optionally include a reinforcing element 206.

[0132] The U-shaped fabric body 201 also includes tension wires 214'. Each arm portion 204 has a portion of the tension wire 214' passing through the arm portion 204 and the base portion 202, with this passage extending from the arm portion 204 at the tip of the base portion 202 to the base portion 202. Each portion of the tension wire 214' is fixed toward the tip of the arm portion 204, but otherwise it can move freely along the arm portion 204 and within the through hole 207 formed in the base portion 202.

[0133] Each arm portion 204 is configured to fold toward the base 202 by the action of a tension wire 214' passed through the arm portion 204. In other words, when a tensile force is applied to the tension wire 214', it can fold the arm portion 204 toward the base 202. To put it another way, the tension wire 214' passed through the arm portion 204 is one example of a means for folding each arm portion 204 toward the base 202 so that body tissue is sandwiched between the base 202 and each of the arm portions 204 during use. Since the U-shaped fabric body 201 is made mainly of soft material, if the tension wire 214' is actuated from the tip of the arm portion 204 rather than where it is fixed to the arm portion 204, the arm portion 204 will fold (i.e., fold toward the base 202).

[0134] Furthermore, an end cap 208 is positioned at the end of the arm portion 204, which is the tip portion relative to the base portion 202. The end cap 208 is a rigid structure that assists in embedding the U-shaped fabric body 201 into the body tissue and also assists in maintaining the engagement of the U-shaped fabric body 201 with the body tissue. Figure 8 shows a closer view of detail A' in Figure 7. The portion of the tension wire 214' that passes through the arm portion 204 is fixed to the tip of the arm portion 214' via an end cap 208. In the embodiments shown in Figures 7 and 8, each end of the tension wire 214' is received and fixed therein by the opening 211 of the end cap 208. Each end cap 208 also has an opening 210 for receiving the wire guide member 218. The use of an end cap 208 that receives a wire guide member 218 for embedding the anchor system 200 simplifies embedding because it is not necessary to embed the fabric body 201 from inside the hollow needle. Therefore, a narrower puncture member can be used to deploy the soft tissue anchor system 200, thus reducing trauma to the embedding site.

[0135] Figures 9A and 9B show a soft tissue anchor system 200 embedded in the mitral valve leaflet 12 of the heart. The base 202 is positioned to contact the atrial surface 12A of the valve leaflet 12, and the foldable arm portion 204 (as shown in Figure 9B) is positioned to contact the ventricular surface 12B of the valve leaflet 12. Thus, the valve leaflet 12 is sandwiched between the base 202 and the arm portion 204 when in use.

[0136] As shown in Figure 9B, the artificial chordae tendineae 214 provides a tensile force to the tension wire 214', indicated by arrow T, thereby pulling its fixed end toward the base 202. This causes the arm 204 to fold into the folded position. The artificial chordae tendineae 214 can be joined to the tension wire 214' via any suitable fastening means, such as a knot or an eyelet. In the embodiment shown in Figure 9B, the artificial chordae tendineae 214 is joined to the tension wire 214' via a knot 215.

[0137] Referring here to Figure 9A, a pair of wire guide members 218 are used to embed the U-shaped fabric body 201. Each wire guide member 218 is received by an opening 210 in an end cap 208. The wire guide members 218 are used to push the end cap 208 into a puncture engagement with the valve leaflet 12, allowing the U-shaped fabric body 201 to engage with the valve leaflet 12 through the valve leaflet 12. In this configuration, the end cap 208 extends substantially colinearly with the arm portion 204. The wire guide members 218 can then be withdrawn once the U-shaped fabric body 201 is embedded in the valve leaflet 12.

[0138] The wire guide member 218 shown in Figure 10A passes through the end cap 208 and is used to puncture the valve leaflet 12, while simultaneously pushing the end cap 208 through the valve leaflet 12. In the configuration shown in Figure 9A, the wire guide member 218 includes a puncture section 219. The puncture section 219 has a tip configured to puncture the valve leaflet 12 during the implantation of the soft tissue anchor system 200. Thus, in the configuration shown in Figure 9A, the wire guide member 218 can be considered the puncturing wire guide member 218. The opening 210 of the end cap 208 extends considerably along the entire length of the end cap 208, allowing the passage of the puncturing wire guide member 218. To assist in the operation of the end cap 208, the wire guide member 218 includes a thicker control section 220. The shoulder portion 221 is located between the thin puncture section 219 and the thicker control section 220 and is configured to engage with a complementary portion of the end cap 208. By transmitting force to the end cap 208 in this manner, the arm portion 204 is pulled through the embedded portion formed by each puncture section 219 of the wire guide member 218.

[0139] Alternatively, as shown in Figures 10A and 10B, the tip 209 of the end cap 208 closer to the arm portion 204 is pointed so that the end cap 208 can puncture the valve leaflet 12. When the tip 209 of the end cap 208 is pointed, the wire guide member 218 is used to transmit force to the end cap 208, puncturing the valve leaflet 12 and pulling the arm portion 204 through the embedded portion formed in the valve leaflet 12 by the pointed tip 209 of the end cap 208. By using the soft tissue anchoring system 200 described above, the catheter device 102 may be adapted to replace the valve leaflet anchoring tube 138 shown in Figures 1 to 6 with an alternative anchor deployment mechanism, such as a tube of a different design for holding and guiding the arm portion of the fabric body when the arm portion is embedded in the valve leaflet.

[0140] Figures 11A to 11C schematically illustrate how the soft tissue anchor system 200 of Figures 7 to 10 can be housed in and deployed from a catheter device. Although each of Figures 11A to 11C shows only the proximal end 1004 of the catheter device, it will be readily apparent that such a proximal end 1004 can be mounted within the catheter device, as described in relation to any of Figures 1 to 6.

[0141] Figure 11A shows the end cap 208 of the soft tissue anchor system 200, which is housed within a channel or groove 1208 and deploys from the proximal end 1004 of the catheter device. The proximal end 1004 functions as a gripping device housing 1006, and therefore the channel 1208 faces the gripping device arm 1030, and as illustrated in Figure 11B, when the valve leaflet 12 is gripped by the gripping device arm 1030, the end cap 208 can be deployed from the channel 1208 by the operation of the respective wire guide members 218.

[0142] The proximal end 1004 of the catheter device also provides a housing 1201 for the U-shaped fabric body 201. Figure 11C shows the U-shaped fabric body 201 when housed within the housing 1201. The housing 1201 for the U-shaped fabric body also faces the gripping device arm 1030, allowing the U-shaped fabric body 201 to be embedded in the gripped valve leaflet 12. The U-shaped fabric body 201 is positioned within a narrow, tubular sheath, or curtain, inside the housing 1201. The sheath acts to reduce friction experienced by the U-shaped fabric body 201 from the housing 1201 while the soft tissue anchor system 200 is deployed from the catheter device. The sheath can flex or compress during deployment to assist in the deployment of the fabric body 201.

[0143] The U-shaped fabric body housing 1201 is open to a channel 1208 for an end cap 208, allowing the arm portion 204 to extend between the end cap channel 1208 and the U-shaped fabric body housing 1201. This configuration facilitates the smooth deployment of the soft tissue anchor system 200 into the valve leaflet 12 grasped from the proximal end portion 1004 of the catheter device.

[0144] Figure 12 shows the catheter device 1000, in particular the proximal end 1004 of the housing of the catheter device 1000. The proximal end 1004 functions as a gripping device housing 1006 and also functions as a housing for an anchoring system, such as a valve leaflet anchoring system that can be deployed from the valve leaflet anchoring system tube 1138. The gripping device housing 1006 is equipped with a gripping device arm 1030, which is a single gripping device arm 1030 in the illustrated configuration. Also provided are a wire guide member 1118, i.e., a control wire configured to deploy the valve leaflet anchor system from the valve leaflet anchor system tube 1138, and a control wire 1040 for a single gripping device, i.e., a control wire configured to actuate the gripping device arm 1030 of the gripping device housing 1006.

[0145] The gripping device arm 1030 includes a plurality of serrated portions 1032. The serrated portions 1032 increase the contact area between the valve leaflet 12 and the gripping device arm 1030 when the gripping device arm 1030 is used to grip the valve leaflet 12 between the proximal end 1004 of the housing of the catheter device 1000 and the gripping device arm 1030 itself. The serrated portions 1032 face the opening of the valve leaflet anchor system tube 1138. The proximal end 1004 of the housing also includes a plurality of serrated teeth 1004A formed on the surface facing the gripping device arm 1030.

[0146] The gripping device arm 1030 also includes an internal space 1034. The internal space 1034 is formed on the surface of the gripping device arm 1030 facing the valve leaflet anchor system tube 1138. The internal space 1034 is configured to receive the wire guide member 1118 and the valve leaflet anchor system during deployment of the valve leaflet anchor system to the valve leaflet 12. The internal space 1034 facilitates the full extension of the wire guide member 1118 during embedding of the anchor system into soft tissue. As shown in the figure, the internal space 1034 defines an opening through the gripping device arm 1030. In other configurations, the internal space 1034 can be a cavity formed on the surface of the gripping device arm 1030.

[0147] The gripping device arm 1030 is rotatably coupled to the proximal end 1004 of the housing, which in this configuration is achieved by a hinge 1036. The gripping device arm 1030 also includes a lever portion 1038. The gripping device control wire 1040 is configured to actuate the gripping device arm 1030 via the lever portion 1038. The gripping device control wire 1040 applies force to the lever portion 1038, thereby generating a moment around the hinge 1036. Accordingly, the gripping device arm 1030 rotates around the hinge 1036 in response to the control input. In this way, the gripping device arm 1030 is capable of rotating away from and around the proximal end 1004 of the housing of the catheter device 1000.

[0148] During use, the gripping device arm 1030 is rotated away from the housing by pulling the gripping device control wire 1040 (i.e., by pulling the gripping device control wire 1040 toward the proximal end, or by returning it to the delivery catheter used to deliver the catheter device 1000). The catheter device 1000 is positioned so that the gripping device arm 1030 can grip the valve leaflet 12. The gripping device arm 1030 is then used to grip the valve leaflet 12 by pushing the gripping device control wire 1040 (i.e., by pushing the gripping device control wire 1040 toward the tip or from the delivery catheter into the catheter device 1000). The valve leaflet 12 is firmly and stably gripped by applying a force F1 through the gripping device control wire 1040, and the gripping device arm 1030 can be kept closed.

[0149] With the valve leaflet 12 held in place, the valve leaflet anchor system can then be deployed from the valve leaflet anchor system tube 1138 by applying a deployment force F2 via the wire guide member 1118. The deployment force F2 causes the valve leaflet anchor system to puncture the valve leaflet 12, thereby embedding it into the valve leaflet 12.

[0150] During the embedding of the valve leaflet anchor system into the valve leaflet 12, the application of the unfolding force F2 by the wire guide member 1118 generates a moment around the hinge 1036 that acts to open the gripping device arm 1030. This may cause the valve leaflet 12 to not be stably and firmly gripped within the gripping device housing 1006. To prevent the gripping device arm 1030 from opening during the implantation of the valve leaflet anchor system, a greater force can be applied via the gripping device control wire 1040. However, applying a greater force may increase the risk of trauma to the valve leaflet 12 and surrounding body tissues, and may also increase the risk of malfunction within the catheter device 1000.

[0151] Accordingly, embodiments of the present invention provide a catheter device equipped with a locking mechanism for the gripping device. The locking mechanism for the gripping device is configured to maintain the gripping device arm in a closed position when gripping the valve leaflet 12 during the embedding of the anchor system into the valve leaflet 12, in particular when an unfolding force F2 is applied by the wire guide member 1118. In particular, embodiments of the present invention envision a configuration in which a control wire for the gripping device is used to control the position of both the gripping device arm and the locking mechanism for the gripping device.

[0152] The catheter devices described herein may have one or more features of the types of catheter devices 2, 1002 described above in relation to Figures 1 to 12, the gripping device housing or gripping devices 6, 106, 1006 shown in these figures being replaced by gripping device arms described below and in relation to the remaining figures, and other modifications will be apparent to those skilled in the art.

[0153] The catheter devices illustrated in or described in relation to the remaining figures are for implanting anchors, such as anchors combined with lines, into soft tissue, and more specifically, can be used as catheter devices for surgical repair of mitral valve leaflets, and the catheter devices are used to attach artificial chordae tendineae to grasped heart valve leaflets during repair. This type of restoration is described in both International Publication No. 2016 / 042022 and International Publication No. 2020 / 109588, and is mentioned above in relation to Figures 1 to 12.

[0154] Figure 13 shows the proximal end 2004 of a catheter device 2000 according to one embodiment of the present invention. The catheter device 2000 has the same form and structure as the catheter device 1000 shown in Figure 12, and the same reference numerals indicate the same features. The catheter device 2000 includes a gripping device locking mechanism 2050. The gripping device locking mechanism 2050 is configured to maintain the gripping device arm 2030 in a closed position when, for example, the gripping device arm 2030 is coplanar with, in contact with, or being pulled by, the proximal end portion 2004 of the housing when gripping the valve leaflet 12. The gripping device control wire 2040 is configured to open and close the gripping device arm 2030, and also to operate the gripping device locking mechanism 2050.

[0155] When the locking mechanism 2050 of the gripping device is engaged, it can provide a certain amount of force to resist the opening of the gripping device arm 2030. The resisting force is provided in a direction having a principal component that is perpendicular to, or substantially perpendicular to, the direction in which the control wire 2040 of the gripping device applies force F1 to the gripping device arm 2040. The resisting force is also provided away from the pivot point of the gripping device arm 2040 (for example, around the hinge 2036 or other suitable pivoting means) to provide a larger resisting force moment to counteract the unfolding force F2 applied to the anchoring system.

[0156] Therefore, the locking mechanism 2050 of the gripping device can prevent or significantly resist the opening of the gripping device arm 2030 during the embedding of the valve leaflet anchor system. For example, if a force F1 of 10N is applied by the control wire 2040 of the gripping device to keep the gripping device arm 2030 in a closed position, the gripping device arm 2030 may not open if the unfolding force F2 is 37N or less. This is in contrast to a configuration without the gripping device locking mechanism 2050, where, when a force F1 of 10N is applied by the locking member 1040 of the gripping device, the gripping device arm 1030 may open due to a deployment force F2 of 3N. Therefore, by using the locking mechanism 2050 of the gripping device, the ability to prevent the gripping device arm 2030 from opening unintentionally under the action of the deployment force F2 can be greatly improved.

[0157] By using the locking mechanism 2050 of the gripping device to maintain the gripping device arm in a closed position, the force applied by the control wire 2040 of the gripping device when gripping the valve leaflet 12 can be reduced. In other words, the locking mechanism 2050 of the gripping mechanism can increase the load required to open the gripping device arm 2030 when it is closed, thereby reducing the force that needs to be provided by the control wire 2040 of the gripping mechanism to prevent the gripping device arm 2030 from opening unintentionally. This may improve the stability of the valve leaflet 12 within the gripping device housing 2006 during the deployment of the valve leaflet anchoring system.

[0158] Furthermore, by providing a gripping device control wire 2040 that can be used to open and close the gripping device arm 2030 and engage the gripping device locking mechanism 2050, the configuration of the catheter device 2000 can be kept simpler and more compact. For example, operating the gripping device housing 2006 using only one control input can prevent malfunctions that may occur with multiple control inputs. Since only one gripping device control wire lumen is required to provide full operation of the gripping device housing 2006, the catheter device 2000 can be made more compact or simpler.

[0159] In this embodiment, the gripping device control wire 2040 is used to open and close the gripping device arm 2030, but in other embodiments, the gripping device control wire 2040 may be replaced with an alternative gripping device control member, such as a gripping device control rod, a gripping device control piston, or other suitable member for controlling the gripping device arm. In this embodiment, the locking mechanism 2050 of the gripping device comprises a link member 2052 and a locking member 2056. The link member 2052 comprises a first end 2054A and a second end 2054B. The link member 2052 is rotatably coupled to the gripping device arm 2030 at its first end 2054A and to the gripping device control wire 2040 at its second end 2054B. The gripping device arm 2030 is rotatably coupled to the link member 2052 toward the end of the lever portion 2038. The gripping device control wire 2040 is rotatably coupled to the link member 2052 via a joint member 2042. The joint member 2042 facilitates the connection between the link member 2052 and the gripping device control wire 2040. The locking member 2056 is fixed to the proximal end 2004 of the catheter device 2000 within the gripping device housing 2006. In this embodiment, the locking member 2056 is fixed toward the tip end 2008 of the housing of the catheter device 2000.

[0160] The link member 2052 includes a first locking portion 2053, and the locking member 2056 includes a second locking portion 2057. The first locking portion 2053 is configured to engage with the second locking portion 2057 when the locking mechanism 2050 of the gripping device is engaged. As shown in Figure 13, in this embodiment, the first locking portion 2053 and the second locking portion 2057 each have a plurality of complementary teeth. The second locking mechanism 2057 is or acts as a ratchet gear rack, and the first locking mechanism 2053 is a plurality of teeth or projections configured to engage with the ratchet gear rack, with the link member 2052 functioning as a pawl. Thus, the locking mechanism 2050 of the gripping device can be considered a ratchet gear rack mechanism.

[0161] Since the first and second locking portions 2053 and 2057 are equipped with multiple complementary teeth, the gripping device arm 2030 can be locked in multiple positions. In this embodiment, the multiple positions are multiple discrete positions. In the most open position, the gripping device arm 2030 is at a distance of approximately 2.8 mm from the adjacent surface of the base end 2004 of the housing. When closed, the gripping device arm 2030 abuts against the adjacent surface of the base end 2004 of the housing. In this position, the serrated teeth 2032 of the gripping device arm 2030 engage with the serrated teeth 2004A of the adjacent surface of the base end 2004 of the housing.

[0162] By providing a locking mechanism 2050 for the gripping device that allows the gripping device arm 2030 to be locked in multiple positions, valve leaflets 12 or other soft tissues of various sizes and thicknesses can be stably gripped by the gripping device arm 2030. During use, the gripping device control wire 2040 is configured to close the gripping device arm 2030. When the gripping device arm 2030 is closed, or when the valve leaflet 12 is gripped in the desired position, the gripping device control wire 2040 is operated to move the link member 2052 to engage with the locking member 2056. The teeth of the first locking part 2053, i.e., the link member 2052l, engage with the second locking part 2057, i.e., the ratchet gear rack. The ratchet gear rack prevents the movement of the pawl (i.e., the link member 2052), thereby preventing the gripping device arm 2030 from opening when the locking mechanism 2050 of the gripping device is engaged.

[0163] Figures 14A to 14C show the locking mechanism 2050 of the gripping device and its components in more detail. Figure 14B shows the locking member 2056 in more detail. In this embodiment, the locking member 2056 comprises a large rack 2056A and a small rack 2056B. The small rack 2056B is attached to the large rack 2056A via two pins 2056D and 2056E with a diameter of 10,000 (0.254 mm). The small rack 2056B is provided with a second locking portion 2057, i.e., multiple teeth. The large rack 2056A facilitates the attachment of the small rack 2056B to the gripping device housing 2006. The large rack 2056A can be welded or bonded to the gripping device housing 2006 and is provided with an opening 2056C for accommodating the hinge fixation of the proximal end 2004 of the housing to the tip 2008 of the housing of the catheter device 2000. In other embodiments, the locking member 2056 can be formed from a single rack with a second locking portion 2057, as shown, for example, in Figure 14.

[0164] Figure 14C shows the link member 2052 in more detail. The link member 2052 is connected to the gripping device control wire 2040 via a pin 2054C with a diameter of 18,000 mm (0.457 mm) at its second end 2054B. At its first end 2054A, and also referring to Figure 15A, the link member 2054 is connected to the gripping device arm 2030 via a pin or projection 2039 extending from the lever portion 2038.

[0165] Figures 15A and 15B illustrate two alternative configurations for the catheter device 2000 according to embodiments of the present invention. In each configuration, contact portions 2055 and 2059 are provided. The contact portions 2055 and 2059 are configured to prevent the gripping device arm 2030 from overextending and locking out in the open position, and to allow smoother movement of the gripping device arm 2030. In each configuration, the contact portions 2055 and 2059 prevent the first end 2054A (i.e., the end to which the link member 2052 is rotatably attached to the gripping arm 2030) from intersecting the axis or plane C-C' extending between the second end 2054B of the link member 2052 and the hinge 2036 of the gripping arm 2030 when the gripping arm 2030 moves between the open and closed positions.

[0166] Referring to Figure 15A, the link member 2042 includes a contact portion 2055. The contact portion 2055 is a projection extending from the first end 2054A of the link member 2052. The contact portion 2055 is configured to contact the surface of the lever portion 2038, i.e., the shoulder region 2038A, when the gripping device arm 2030 is opened. The contact portion 2055 prevents the gripping device arm 2030 from opening further when the contact portion 2055 contacts the lever portion 2038 of the gripping device arm 2030. Therefore, the contact portion 2055 is configured to contact the shoulder region 2038A of the lever portion 2038 when the gripping device arm 2030 is in its most open position or in its most open form.

[0167] Referring to Figure 15B, the contact portion 2059 is a column or bar located within the gripping device housing 2006. The contact portion 2059 is configured to prevent the gripping device arm 2030 from opening further by restricting the translation of the link member 2042, that is, by contacting the link member 2052 when the gripping device arm 2030 opens. Figure 16 shows an alternative locking mechanism 2050 for the gripping device. The locking mechanism 2050 for the gripping device differs in that a link member 2052 is fixed to the control wire 2040 of the gripping device via a hinge joint. The joint member 2042 of the control wire 2040 of the gripping device comprises a cylindrical member 2043 that engages with the second end 2054B of the link member 2052 via a snap-fit ​​engagement.

[0168] The link member 2052 also includes a contact portion 2055, which in this embodiment is a projection extending from the second end portion 2054B, as shown in Figure 16. The contact portion 2055 is configured to contact the joint member 2042, thereby preventing excessive extension of the gripping device arm 2030. Figures 17A to 17E show the modified locking mechanism 2050 of the gripping device. In each configuration, the link member 2052 is rotatably attached to the gripping device arm 2030 at a first end 2054A, but instead is fixed to the gripping device control wire 2040 at a second end 2054B. Thus, the link member 2052 does not rotate relative to the gripping device control wire 2040.

[0169] The link member 2052 is attached to the gripping device arm 2030 via a pin 2039 of the gripping device arm extending from the lever portion 2038. The pin 2039 passes through an opening formed in the first end 2054A of the link member 2052. In this embodiment, the opening is wider than the pin 2039 so that there is a gap or clearance between the pin 2039 and the opening. Thus, the link member 2052 is configured to transmit control input from the gripping device control wire 2040 to the gripping device arm 2030 with a degree of play or backlash. Such operation can provide smoother control of the first locking portion 2053 when engaged with the locking mechanism 2053 of the gripping device.

[0170] In some embodiments, the link member 2052 can be an integral component of the gripping device's control wire 2040. For example, the link member 2052 can be permanently fixed to the gripping device's control wire 2040 via welding or adhesive. In the embodiment shown in Figure 17A, the gripping device's control wire 2040 and the link member 2052 are formed as a single structure such that the link member 2052 is a fixed part of the gripping device's control wire 2040. In other embodiments, the link member 2052 can be fixedly coupled to the gripping device's control wire 2040 via a fixed connection. For example, the link member 2052 may have a socket for receiving the gripping device's control wire 2040. In the embodiments shown in Figures 17B and 17C, the gripping device's control wire 2040 is connected to the link member 2052 so as to be fixed via an interlocking fit.

[0171] In some embodiments, the link member 2052 may have a first locking portion 2053 having a single tooth or projection, as shown in Figure 17B, or in other embodiments, the link member 2052 may have a first locking portion 2053 having multiple teeth or projections, as shown in Figure 17C. Providing multiple teeth can improve the control resolution of the link member 2052 because there are multiple stable positions for the link member 2052 to engage with the locking member 2056.

[0172] Figures 17D and 17E show further modified configurations for the locking mechanism 2050 of the gripping device. In each configuration, the locking member 2056 comprises a first rack 2056D and a second rack 2056E. The first rack 2056D is used to secure the locking member 2056 to the proximal end 2004 of the housing of the catheter device 2000. The second rack 2056E, in the illustrated embodiment, comprises a second locking portion 2057 having a plurality of teeth. The second rack 2056E is fixed to the first rack 2056D via an elastic mechanism 2056F; that is, the second rack 2056E is elastically fixed to the first rack 2056D. The second rack 2056E is elastically biased to extend in the direction of the base end.

[0173] During use, the control wire 2040 of the gripping device can apply force toward the tip when closing the gripping device arm 2030. In this way, the link member 2052 can be forcibly engaged with the second rack 2056E of the locking member 2056. The link member 2052 may also deform the elastic mechanism 2056F, thereby compressing the second rack 2056E toward the tip. This movement changes the angle of the second locking portion 2057, allowing the link member 2052 to slide along the locking member 2056. When the gripping device arm 2030 is closed to the desired extent, the force applied by the gripping device control wire 2040 can be relieved. Next, the elastic mechanism 2056F causes the second rack 2056E to spring back, allowing the first locking portion 2053 of the link member 2052 to engage with the second locking portion 2057 of the locking member 2056.

[0174] Referring to Figure 17D, in some embodiments, the elastic mechanism 2056F comprises a flat spring formed by cutting the locking member 2056. In this embodiment, the locking member 2056 is cut from a single piece of metal. Thus, the first rack 2056D and the second rack 2056E are either integrally formed or a single structure.

[0175] Figure 17E shows an alternative elastic mechanism 2056F. The elastic mechanism 2056F comprises a spring member extending between the first rack 2056D and the second rack 2056E. The second rack 2056E is connected to the first rack 2056D by the spring member via a rotatable joint 2056G.

[0176] Figure 18 shows a locking mechanism 2050 of an alternative gripping device equipped with a sprag clutch. The first locking portion 2053 of the link member 2052 contains a sprag, and the second locking portion 2057 of the locking member 2056 defines a race. The sprag is formed to prevent the link member 2052 from reversing when the sprag engages with the race. The reversing force of the sprag clutch depends on the frictional force between the first locking portion 2053 and the second locking portion 2057. A control wire 2040 of the gripping device generates a contact force Fn between the first locking portion 2053 and the second locking portion 2057. The frictional resistance force Fr is generated in the opposite direction to the opening direction of the gripping device arm 2030. This prevents the gripping device arm 2030 from opening, or at least increases the force required to unintentionally open the gripping device arm 2030 during the embedding of the anchor system. Due to the shape of the sprag, the gripping device locking mechanism 2050 resists opening the gripping device arm 2030 more than it resists closing the gripping device arm 2030.

[0177] The frictional force generated when the locking mechanism of the gripping device engages depends on the coefficient of friction of the material used to form the engagement surfaces of the first locking portion 2053 and the second locking portion 2057. When steel is used for both locking portions 2053 and 2057, the coefficient of friction is approximately 0.1 to 0.3. The frictional force can be increased by using appropriate alternative materials. In this embodiment, the first locking portion 2053 of the link member 2052 comprises a single sprag. However, in other embodiments, the first locking portion 2053 may comprise a plurality of sprags configured to engage simultaneously with the second locking portion 2057, each at the same time.

[0178] Figure 19A shows a locking mechanism 2050 of another alternative gripping device equipped with a ratchet gear rack mechanism. The first locking portion 2053 is a toothed projection mounted on a link member via a spring member 2059A. The second locking portion 2057 is a ratchet gear rack. The spring member 2059A is a curved leaf spring. The first end of the spring member 2059A is connected to the link member 2052 toward the second end 2054B, and the first locking portion 2053 is located at the second end opposite the spring member 2059A. During use, the control wire 2040 of the gripping device applies a force toward the tip, moving the first locking portion 2053 to engage with the second locking portion 2057. The spring member 2059A may introduce a degree of alignment that allows the first locking portion 2053 to engage more easily with the second locking portion 2057.

[0179] Figure 19B shows a modified form of the link member 2052 in Figure 20A. In this modification, the first end of the spring member 2059A is connected to the second end 2054B of the link member 2052, and the second end of the spring member 2059A is connected to the first end 2054A of the link member 2052 via a hinge joint. The hinge joint comprises a cylindrical member 2059B that fits into a socket 2059C via a snap-fit ​​engagement. The hinge joint can provide additional support to the spring member 2059A during the engagement of the first locking portion 2053 to the second locking portion 2057, because when the locking mechanism 2050 of the gripping device is engaged, force is transmitted both through the spring member 2059A itself and through the hinge joint.

Claims

1. A catheter device for implanting an anchor system into soft tissue, A gripping device configured to grasp soft tissue and move between a closed state in which the soft tissue is grasped and an open state in which the soft tissue is not grasped, A control member for a gripping device configured to move the gripping device between a closed state and an open state, The system comprises an anchor system deployment mechanism configured to deploy the anchor system within the soft tissue when the soft tissue is grasped by the gripping device, The catheter device is characterized by comprising a locking mechanism for the gripping device, which is configured to lock the gripping device in a closed position so that it can be released while the anchor system is deployed.

2. The catheter device according to claim 1, wherein the control member of the gripping device is configured to operate the locking mechanism of the gripping device.

3. The catheter device according to claim 1 or 2, wherein the locking mechanism of the gripping device is configured to lock the gripping device in a releaseable position to one of a plurality of positions when it is in the closed position.

4. It has a housing portion that extends from the base to the tip, The catheter device according to claim 1, 2, or 3, wherein the gripping device comprises a gripping device arm connected to the housing portion.

5. The locking mechanism of the gripping device comprises a link member that connects the control member of the gripping device to the gripping device arm, and a locking member fixedly attached to the housing portion. The catheter device according to claim 4, wherein the link member is configured to engage with a locking member to releasably lock the gripping device arm.

6. The catheter device according to claim 5, wherein the locking member comprises a ratchet gear rack, and the linking member comprises a projection configured to engage with the ratchet gear rack.

7. The catheter device according to claim 6, wherein the link member comprises a plurality of protrusions configured to engage with the ratchet gear rack.

8. The catheter device according to claim 5, 6, or 7, wherein the first end of the link member is rotatably coupled to the gripping device arm, and the second end of the link member is rotatably coupled to the control member of the gripping device.

9. The locking mechanism of the gripping device includes a contact portion, The catheter device according to claim 8, wherein the contact portion is configured to prevent the first end of the link member from crossing the axis extending between the second end of the link member and the rotation center of the gripping device arm when the gripping device arm moves between a closed and an open position.

10. The catheter device according to claim 9, wherein the contact portion is a projection extending from the first end of the link member, and the projection is configured to abut against the shoulder region of the gripping device arm when the gripping device arm is in an open position.

11. The catheter device according to claim 9, wherein the contact portion is a support column disposed within the housing portion, and the support column is configured to contact the link member when the gripping device arm is in the open position.

12. The catheter device according to claim 5, 6, or 7, wherein the first end of the link member is rotatably connected to the gripping device arm, and the second end of the link member is fixed to the control member of the gripping device.

13. The catheter device according to claim 12, wherein the first end of the link member has an opening rotatably connected to a pin of a gripping device arm, and there is a gap between the pin and the opening.

14. The catheter device according to any one of claims 1 to 13, wherein the gripping device comprises a plurality of serrated portions for gripping soft tissue.

15. The catheter device according to any one of claims 1 to 14, wherein the gripping device comprises an internal space configured to receive the anchor system during deployment of the anchor system.

16. Furthermore, the catheter device according to any one of claims 1 to 15, comprising a soft tissue anchor system disposed within the anchor system deployment mechanism.

17. The catheter device according to claim 16, wherein the soft tissue anchoring system comprises a U-shaped fabric body having a base and at least two arm portions extending from the base, and each arm portion is configured to fold toward the base so that soft tissue is sandwiched between the base and each of the arm portions when in use.

18. Each arm portion is provided with an end cap fixed to the end of each arm portion relative to the base, and each end cap has an opening configured to engage with a wire guide member for embedding the U-shaped fabric body into the soft tissue, and the catheter device further incidentally comprises such a wire guide member for deploying the soft tissue anchor system, according to claim 17.

19. The catheter device according to any one of claims 1 to 18, wherein the anchor system is a valve leaflet anchor system, the soft tissue is a valve leaflet of the heart, and the catheter device is for implanting the valve leaflet anchor system into the valve leaflet of the heart to fix an artificial chordae tendineae.

20. The catheter device has a housing portion consisting of two parts that extend along the length of the catheter device from the proximal end to the tip of the catheter device, Here, the housing portion, which consists of two parts, comprises a proximal end located at the proximal end of the catheter device and a distal end located on the distal side of the proximal end. The catheter device according to any one of claims 1 to 17, wherein the gripping device, the control member of the gripping device, and the first anchor system deployment mechanism are arranged at the base end of a housing portion consisting of two parts, the first anchor system deployment mechanism is the anchor system deployment mechanism, the tip of the housing portion consisting of two parts comprises a second anchor system deployment mechanism, and the second anchor system deployment mechanism is configured to deploy the second anchor system into further soft tissue by moving the second anchor system outward in the tip direction relative to the tip.

21. The catheter device according to claim 20, wherein the first anchoring system is a valve leaflet anchoring system, the soft tissue is a valve leaflet of the heart, the second anchoring system is a papillary muscle anchoring system, the further soft tissue is a papillary muscle, and the catheter device is for repairing the heart by implanting the valve leaflet anchoring system and the papillary muscle anchoring system to fix an artificial chordae tendineae.

22. A method for using a catheter device according to any one of claims 1 to 21 for the repair of soft tissue, A process of moving the gripping device from a closed position to an open position, A step of bringing the surface of the gripping device into contact with soft tissue, A step of moving the gripping device from an open position to a closed position to grasp soft tissue, The process of engaging with the locking mechanism of the gripping device, A method for using a catheter device, including the step of deploying an anchor system into soft tissue.

Images