Heart repair device

Abstract

A catheter device (2) is provided for implanting an anchor (9) into body tissue to attach a wire (14) to the body tissue. The catheter device (2) comprises: a housing section (4), (8) extending from the distal end of the catheter device (2) along the length of the catheter device (2) toward the proximal end of the catheter device, the housing section (4), (8) comprising a distal portion (8) at the distal end of the catheter device (2) and a proximal portion (4) located proximal to the distal portion (8). An anchor deployment mechanism (106), (110) is provided at the distal portion (8) of the housing section (4), (8) for deploying the anchor (9) to attach the anchor (9) to the body tissue. The anchor (9) is maintained in its stowed position by an anchor deployment mechanism (106), (110) in the distal portion (8) before deployment, and the anchor (9) includes a plurality of hooks (62) for engaging with body tissue and having a folded position and an unfolded position, wherein the anchor (9) is made of an elastic material so that the hooks (62) can be elastically deformed to the folded position by applying a restraining force and will return to the unfolded position when no restraining force is applied, and wherein the hooks (62) are maintained in the folded position while the anchor (9) is in the stowed position within the distal portion (8). The distal portion (8) of the housing (4), (8) has a non-circular shape (118), (117) for engaging with a corresponding non-circular form (28), (108) of the anchor (9) and / or the anchor deployment mechanism (106), (110), so that: when the anchor (9) is retained in the distal portion (8), due to the engagement between the non-circular shape (118), (117) and the non-circular form (28), (108), the movement of the anchor (9) is limited relative to the rotation of the anchor (9) around the longitudinal axis of the distal portion (8).

Description

[0001] The present invention relates to various parts of a device for implanting an artificial chordae line to repair a heart valve, and related methods. The present disclosure also includes an anchor for implantation in body tissue, which can be used for heart repair.

[0002] The chordae tendineae are cord-like tendons that connect the papillary muscles to the tricuspid and mitral valves in the heart. These valves are made up of leaflets that open and close as the heart beats to control blood flow and blood pressure within the heart.

[0003] Mitral valve disease presents a significant challenge to cardiac surgeons and cardiologists. Mitral regurgitation has become the most important mitral valve pathophysiological condition in developed countries. One of the most important causes of regurgitation is prolapse of one of the mitral valve leaflets. The pathological abnormality that requires repair is a rupture or other degenerative change in the chordae, leaflets, or other associated structures. When the chordae remain intact, the mitral valve leaflets open and close synchronously and in a manner that prevents valve leakage. Normal chordae may rupture acutely, resulting in acute decompensation in the form of heart failure. This often results in an emergency situation that requires rapid intervention. Damage to the chordae may also occur more slowly, including rupture or elongation due to degenerative processes, resulting in leakage or regurgitation in the mitral valve.

[0004] Surgical repair of the mitral valve has become relatively standardized, with resection of the prolapsed leaflets and / or implantation of new artificial cables to control leaflet movement. In addition, a mitral valve annulus is often placed to shrink the size of the mitral valve annulus. Surgical replacement of broken or elongated cables is highly effective in eliminating or minimizing mitral regurgitation. Currently, the procedure is performed using open heart surgical techniques. This requires the use of cardiopulmonary bypass and cardiac arrest. This surgical approach, while working well, is a highly invasive procedure that can cause serious complications, long hospital stays, and considerable expense. Therefore, a less invasive approach would be preferred.

[0005] Insertion of mitral valve leaflet cords has been accomplished using a minimally invasive surgical approach that enters the heart through the apex of the heart. This technique was developed by Neochord Ltd and described, for example, in WO 2012 / 167120, but still requires a surgical incision and the cords cannot be inserted into the papillary muscles where they would normally be secured.

[0006] WO 2008 / 101113 describes another example of a system for repairing a heart, including the implantation of an artificial cable. In the described method, an anchor can be attached to a papillary muscle and connected to the leaflet of a mitral valve by an artificial cable, suture and a clip. The clip allows the length of the artificial cable to be adjusted. A complex multi-stage process is required to implant the papillary anchor and suture and join them together. The papillary anchor is formed of a memory metal (e.g., nitinol) and has a "flower-like" shape with sharp "petals" for hooking the anchor to body tissue. The flower-like shape is flattened into a tubular shape and is retained in a tube that enters the heart. The tube and anchor are then pressed against the papillary muscle, and the anchor is pushed out of the tube so that the flap pierces the muscle and folds outward through the muscle to provide a firm connection between the anchor and the muscle tissue. In a subsequent surgical procedure, an artificial cable can be attached to the anchor. Then in a further step, a suture is attached to the leaflet and the suture is joined to the cable by a clip. The suture is attached to the leaflet by positioning a vacuum port adjacent to the leaflet and pulling it into the vacuum port where the suture can be pierced.

[0007] It will be appreciated that this technique, while avoiding open heart surgery, still requires a relatively complex series of steps. The number of steps required increases the risk. Furthermore, the complexity of the device means that there is a risk that the implanted portion may become loose and injure the patient due to embolism. In particular, the clip may become loose from the anchor. It is also believed that the use of a suture with an attached clip, as proposed, may not be effective in repairing a heart valve, as it will not closely mimic the natural cord.

[0008] In an earlier patent application WO2016 / 042022, the applicant disclosed a catheter device for implanting an artificial cable to repair a heart valve. The catheter device of WO2016 / 042022 includes a mechanical clamping device for grasping a heart valve leaflet, and the leaflet anchor is accommodated in the clamp. The leaflet anchor can be formed of a flexible material (e.g., nitinol), has a grappling hook shape in an unfolded configuration, and can be elastically deformed into a folded configuration, for example, when constrained in a leaflet anchor channel in the clamping device. When the leaflet anchor is in the folded configuration, the hooks are straightened. When the leaflet is clamped by the clamping device, the leaflet anchor can be pushed out of the clamp to drive the hook through the leaflet, while they elastically return to the unfolded configuration, thereby fixing the leaflet anchor in the leaflet.

[0009] The device described in WO2016 / 042022 also uses a papillary anchor with a substantially similar arrangement of foldable hooks. The papillary anchor is held within the tube of the catheter device in a folded configuration and can be pushed out of the tube by means of the hooks being driven through the papillary muscle while elastically returning to the unfolded configuration, thereby securing the papillary anchor to the muscle. The papillary anchor includes a locking ring acting as a locking mechanism for clamping an artificial cord when no force is applied. The locking ring can be elastically deformed to release the cord from the locking mechanism for adjusting the length of the cord.

[0010] While the device of WO2016 / 042022 provides a significant advance in the field, it has been found that further improvements to the design may be advantageous. The present disclosure relates to novel features of the design and construction of the device disclosed in WO2016 / 042022 in various aspects.

[0011] According to the present invention there is provided a catheter device as discussed in the fourth aspect.

[0012] From a first aspect, the present invention provides a catheter device for repairing a heart by implanting an artificial cable, the catheter device comprising: a leaflet anchor for placement in a leaflet of a heart valve, wherein the leaflet anchor is arranged to be connected to the artificial cable; and a leaflet anchor deployment mechanism for deploying the leaflet anchor to attach it to the leaflet of the heart, wherein the leaflet anchor deployment mechanism comprises a mechanical clamping device for grasping the leaflet of the heart valve, wherein the clamping device comprises a leaflet anchor tube for accommodating the leaflet anchor in a folded configuration; the clamping device and the leaflet anchor are arranged so that in use, when the clamping device grasps the leaflet, the leaflet anchor can be pushed out of the leaflet anchor tube to pierce the leaflet and form the leaflet anchor into an unfolded configuration, so that the hook-shaped configuration of the leaflet anchor can fix the leaflet anchor in use. in this leaflet; wherein the mechanical clamping device includes a first clamping arm and a second clamping arm, the first clamping arm being rotatably connected to the body of the catheter device so that the first clamping arm can be rotated relative to the catheter device to move the outer end of the first clamping arm away from the body of the catheter device, and the second clamping arm being rotatably and / or slidably connected to the body of the catheter device so that the second clamping arm can be rotated and / or slidable relative to the body of the catheter device to move the outer end of the second clamping arm away from the body of the catheter device; and wherein the first clamping arm and the second clamping arm are arranged so that: they can move to contact each other at a point spaced apart from the body of the catheter device.

[0013] This arrangement can provide various advantages. For example, in an arrangement where the second gripper arm is rotatably coupled to the body of the catheter device and / or in an arrangement where the second gripper arm can react to sufficiently high forces from the first gripper arm, then using two gripper arms allows the leaflet to be clamped between the two arms at a point spaced from the body, rather than only enabling the leaflet to be clamped between a single gripper arm and the body, which is the arrangement described in WO2016 / 042022. Using two gripper arms in this manner can additionally or alternatively help stabilize a flail leaflet, which is a leaflet segment without a functional cord that can flail into the atrium and is difficult to grasp with prior art devices. For example, the leaflet tends to move upward, which makes it difficult to grasp the leaflet using a single gripper arm alone. Thus, in this regard, the second gripper arm can be considered a "leaflet motion inhibitor" because it can help stabilize the flail motion of the leaflet during the cardiac cycle. The use of a second clamp arm may also allow for a more horizontal clamping / contact surface (i.e., more perpendicular to the body of the catheter device), which is beneficial both in terms of constraining the orientation of the body, which is typically inserted above the leaflets, and has further advantages relative to the exemplary embodiment in which the leaflet anchors are implanted using the same apparatus as the papillary anchors. Specifically, the use of two clamp arms with a more perpendicular clamping position may facilitate the use of the apparatus to perform the process of implanting both the leaflet anchors and the papillary anchors while the apparatus remains in one position. It should be understood that the clamp arms need not be rigid structures, but may be flexible as desired to achieve their desired operation.

[0014] In some examples, the use of two clamp arms allows the movement of the leaflet to be restricted between the two clamp arms at a point spaced apart from the body. Thus, at (and near) the point where the first clamp arm and the second clamp arm can contact each other, when a leaflet is present, they will engage with the leaflet and restrict its movement. The leaflet tends to move upward, which may make it difficult to grasp the leaflet using a single clamp arm alone. Therefore, in this regard, the second clamp arm can be considered a "leaflet motion inhibitor" because it can help stabilize the flail motion of the leaflet during the cardiac cycle. Therefore, in this embodiment, the second clamp arm can be slidably moved away from the body of the catheter device to contact the top of the leaflet. The catheter device can be moved downward so that the first clamp arm can then be rotatably moved away from the body of the catheter device without contacting the leaflet or the second clamp arm before rotating back toward the leaflet or the second clamp arm. When the first clamp arm rotates back into the body, it then contacts the second clamp arm, which may be a flexible arm, for example, to confine the leaflet between the two. In this case, the contact made by the first clamp arm against the second clamp arm may be a slidable contact, allowing the first clamp arm to rotate back toward the body while maintaining restraint on the leaflet. The first clamp arm then grasps the leaflet between itself and the body of the catheter device. Therefore, when the first clamp arm is withdrawn to clamp the leaflet between the first clamp arm and the body, similar to what is described for a single clamp arm in WO2016 / 042022, the second clamp arm confines the leaflet and prevents it from sliding out, and the presence of the second clamp arm therefore ensures that the leaflet is captured in the first clamp arm. Use of a second clamp arm will also allow for a more horizontal clamping surface (i.e., more perpendicular to the body of the catheter device), which is beneficial both in terms of constraining the orientation of the body, which is typically inserted from above the leaflets, and has further advantages relative to the exemplary embodiment in which the leaflet anchor is implanted using the same apparatus as the papillary anchor. Specifically, use of two clamp arms with a more perpendicular contact position can facilitate use of the apparatus for performing the procedure of implanting both the leaflet anchor and the papillary anchor while the apparatus remains in one position. It should be understood that the clamp arms need not be rigid structures, but can be flexible as needed to achieve their desired operation.

[0015] The improved design can also allow the majority of the device to be made of a resilient metal (e.g., nitinol or stainless steel), and this in turn can allow a repeatable and inexpensive production method. Alternatively, the majority of the device can be made of a composite material, wherein a selection portion is suitably formed of an elastic material such as nitinol or stainless steel. Composite materials can include, for example, glass reinforced PEEK or carbon reinforced PEEK (CRF PEEK). Composite materials can have the advantage of improved imaging from ultrasound to allow monitoring during any process using a catheter device. Although composite materials may not be visible in x-ray imaging, radioactive markers or opaque contrast markers can be strategically located on the device to provide such imaging. Composite materials can also be used for injection molding of the parts of a catheter device as needed.

[0016] It will be appreciated that the leaflet anchor deployment mechanism of this aspect, as well as providing its own advantages, may also be combined in conjunction with the catheter device of the aspect described below. Thus, it may be used to deploy the leaflet anchor in the device of the second aspect, for example placing the leaflet anchor deployment mechanism in the proximal portion of the two-part housing section. Alternatively or additionally, it may be combined with the use of an ejector unit as disclosed with respect to this sixth aspect.

[0017] Capturing the leaflet with a flail can be challenging because it can move "up" and "down" during a heartbeat. The clamping device of this aspect is equipped with an additional clamp arm to address this problem. Both clamp arms are movable relative to the body of the catheter device. In some examples, the first clamp arm is used to surround the second clamp arm so that the first clamp arm must be rotated a certain amount away from the body of the catheter device before the second clamp arm is able to freely rotate and / or slide throughout its full range of motion. It is possible that the second clamp arm can only move relative to the body of the catheter device once the first clamp arm is opened to a certain extent.

[0018] The leaflet anchor tube may be housed within the first clamp arm or the second clamp arm. The leaflet anchor is deployed by pushing the leaflet anchor out of an opening at the end of the leaflet anchor tube, which is at the end of the corresponding clamp arm. In these exemplary embodiments, the leaflet anchor tube is within the first clamp arm, which may also surround the second clamp arm as discussed above.

[0019] The two gripper arms may be individually operable to allow independent movement. Alternatively, they may be connected so that they move simultaneously similar to a "tweezers" mechanism. Using two gripper arms may allow the upper gripper arm (which may be the second gripper arm) to form a "top" for the leaflet, reducing movement and making grasping easier, particularly when the leaflet is a complete flail. Another advantage is that the grasping action is more horizontal than vertical, i.e., more perpendicular to the body of the catheter device rather than parallel thereto.

[0020] In one example, the first clamp arm can be arranged to open by rotating away from the body 45 degrees or more, and preferably rotated to an obtuse angle to open. The second clamp arm can be arranged to be surrounded by the first clamp arm when the first clamp arm is closed, and once the first clamp arm is opened, the second clamp arm can swing outward and / or slide from the body of the catheter device. In the case of the second clamp arm rotating, the second clamp arm can then rotate in a rotation direction opposite to the first clamp arm and can be arranged so that the rotation brings the end of the second clamp arm into the movement path of the end of the first clamp arm. Compared with the rotation center of the second clamp arm, the rotation center of the first clamp arm can be spaced apart along the length of the body of the catheter device. It should be noted that the rotation center may not be fixed, because there may be some deformation of the device during the rotation process, such as the first clamp arm can be rotated by the bending of the flexible section of the material, which can cause the movement of the rotation center according to the degree of bending. Where the second gripper arm slides, it may slide to move its end outwardly from the body of the catheter device and into the path of movement of the end of the first gripper arm.

[0021] The gripper arm can be moved by pulling one or more wires, which can be connected to a plurality of lever arms coupled to the gripper arm. With the second gripper arm open (i.e., rotated or slid outwardly from the body) and its end spaced from the body, such as where the second gripper arm extends at an angle between 45-90 degrees from the body, the first gripper arm can be rotated in a closing direction toward the end of the second gripper arm so that the first gripper arm moves to contact a portion of the second gripper arm.

[0022] In some examples, the clamping device can capture the leaflet and / or limit its movement by engagement (contact) of the two clamp arms, which can be accomplished by rotation of one or both arms. The second clamp arm can also move independently during the clamping action. The two clamp arms can move so that the clamping surface of the second clamp arm engages with the clamping surface of the first clamp arm.

[0023] The gripping device can capture the leaflet by first constraining the leaflet between the contact point between the second gripper arm and the first gripper arm. The first gripper arm can then be rotated closed, i.e., rotated toward the body of the catheter device, so that the first gripper arm successfully grasps the constrained leaflet. The second gripper arm can be fixedly held in place during the movement of the first gripper arm.

[0024] For a clamp arm that receives a leaflet anchor tube, which may be a first clamp arm, the clamping surface may be a clamping platform located around the opening of the leaflet anchor tube. When the leaflet is clamped between the two clamp arms or between a clamp arm and the body of the catheter device, the leaflet anchor is placed, for example using any of the techniques discussed above, and then the clamping device is opened, for example by rotating the first clamp arm away from the second clamp arm and / or the body of the catheter device. Where the device of this aspect is combined with the device of the sixth aspect and where an ejector unit is therefore present, the attachment of the leaflet may be tested after opening the clamping device to ensure proper placement of the leaflet anchor in the leaflet before the leaflet anchor is released from the ejector unit.

[0025] The second gripper arm may be actuated with two wires, allowing the physician to move the second gripper arm in two rotational or sliding directions to assist in the grasping process.

[0026] The second clamp arm (i.e., leaflet motion inhibitor) can be a flexible member and / or can include a wire. The wire can be formed of an elastic material so that the wire can be contained, accommodated, stored and / or covered in the cavity of the body of the catheter device when not in use. The elastic material can be, for example, nitinol or stainless steel. This advantageously allows the user of the device to decide whether it is desired to use the second clamp arm during placement of the leaflet anchor.

[0027] The leaflet motion inhibitor comprising an elastic wire can be in an elastically deformed state when stored in the cavity. However, when the leaflet motion inhibitor moves away from the body of the catheter device, the leaflet motion inhibitor can return to an undeformed state. The leaflet motion inhibitor can slide out of the cavity to move its end away from the body of the catheter device.

[0028] The leaflet motion inhibitor may include a plurality of shapes and / or arrangements capable of inhibiting flail of the leaflet when the leaflet motion inhibitor is in its undeformed state to ensure engagement of the leaflet between the first and second clamp arms.

[0029] In one example, the second clamp arm can be a looped nitinol wire that is pushed out of the proximal end of the device by pushing the two proximal wire ends toward the distal end of the device, the looped wire extending from the proximal end of the clamp housing. The loop in the wire can advantageously stabilize the leaflet motion inhibitor as it engages the leaflets. The wire loop can encompass a large surface area that aids in leaflet engagement.

[0030] The wire loop may also prevent the leaflet motion inhibitor from being fully withdrawn into the catheter device. That is, the wire loop may engage with a feature of the cavity (e.g., a pin) such that the distal end of the wire is always outside of and / or flush with the body of the catheter device. Thus, for a leaflet motion inhibitor that includes a wire, a portion of the wire and / or an end of the wire may be outside of / flush with the outer surface of the proximal portion of the body of the catheter device.

[0031] In another example, the second clamp arm can be an open-ended and / or slack wire, i.e., a wire in which at least one end is located outside the body of the catheter device when the catheter device is in an undeformed state. The wire, being open-ended and not forming a loop, can help prevent the leaflet from becoming entangled in the leaflet motion inhibitor. In this arrangement, the leaflet motion inhibitor can include multiple bends and / or curves parallel to the plane of the leaflet, which advantageously increases the engagement surface area between the leaflet motion inhibitor and the leaflet. In order to prevent the leaflet motion inhibitor from being completely withdrawn into the catheter device, the wire can include a wire stop at its end, which is a feature that makes the wire stop wider and / or larger than the cavity.

[0032] When the leaflet motion inhibitor comprises a wire and at least one end of the wire is configured to be outside the body of the catheter device, the leaflet motion inhibitor may undesirably pierce and / or damage the leaflet or surrounding tissue when the second clamp arm slides out and / or moves away from the body of the catheter device. In order to prevent such adverse effects, the bends and / or curves of the wire can be formed so that the ends of the wire are configured to point in a direction away from the leaflet. For example, the ends of the wire can be bent away from the surface of the leaflet, or can point in a direction opposite to the direction in which the second clamp arm will be moved. Additionally and / or alternatively, the ends of the wire may include a soft tip to reduce the chance of piercing surrounding tissue.

[0033] In one example, the undeformed shape of the leaflet can include a spiral that forms a large engagement surface between the leaflet and the second clamp arm. The spiral can also be formed so that the end of the wire located outside the body of the catheter device is located at the center of the spiral. Advantageously, this reduces the possibility of the end of the wire piercing and / or damaging surrounding tissue because the end of the wire is less exposed.

[0034] The cavity in which the leaflet motion inhibitor is stored may include a channel, path and / or conduit extending along the length of the catheter device parallel to the main axis of the catheter. However, where the cavity meets the mechanical clamping device, the cavity may be angled toward the outer surface of the body of the catheter device so that the leaflet motion inhibitor can slide out of the cavity to engage the leaflets. The cavity may be angled so that the leaflet motion inhibitor leaves the cavity perpendicular to the surface of the body of the catheter device.

[0035] The wire component of the leaflet motion inhibitor can be a ready-made wire, such as a guide wire, which can be easily used in cardiac intervention. Therefore, the operator of the catheter device can then select the wire that they find suitable for inhibiting leaflet motion during surgery. In other words, different wires of the same predetermined size can be implemented with different hardness and / or tip structures (i.e., bends, curves and / or loops) as needed. For example, if the first wire does not work as expected, a second wire with similar or different characteristics can be used. In this way, the leaflet motion inhibitor may not be permanently stored in the cavity of the catheter device, but can be selected from a storage device and inserted into the port of the catheter device during a particularly challenging procedure. The method has the further advantage that it can use wire components that have been granted regulatory approval and / or wire components that are familiar to users from other types of cardiac interventions.

[0036] The first gripper arm can be actuated with a single wire or with multiple wires. Advantages can be obtained if the articulation mechanism of the first gripper arm is formed integrally with the material of the body and is rotated away from the body by elastic deformation of the material. The first gripper arm and the articulation mechanism can be formed integrally with the material of the body. Alternatively, the first gripper arm can comprise a separately formed arm section, for example a milled or laser cut piece, wherein the separate arm section is attached to the articulation mechanism of the body, for example by gluing or welding.

[0037] In a slightly different arrangement, the second gripper arm can be attached to the base of the first gripper arm (somewhere near the rotation "axis") . The second gripper arm can be a resilient material such as Nitinol. In the default configuration, the second gripper arm can follow the gripping surface (inner surface) of the first gripper arm with a slight pressure toward the gripping surface of the first gripper arm, where the pressure is caused by tension in the material of the second gripper arm. This arrangement can be compared to "reverse" tweezers that require a force to open it. The reverse tweezers follow the movement of the first gripper arm unless there is a force to pull it apart, which force can, for example, be in the form of a wedge or pull wire placed between the first and second gripper arms.

[0038] In some examples, the body of the catheter device may be formed from a resilient metal such as Nitinol, with the hinge being provided by an elastic joint formed in the resilient metal. In this case, a single wire may be used to elastically deform the first clamp arm by bending the elastic joint with the body to rotate the end of the first clamp arm away from the body, with the first clamp arm elastically returning to its resting position once no force is applied to the wire. This has the advantage that when the force is released from the wire, the elastic force of the first clamp arm may hold it in place against the second clamp arm without the need to pull a separate wire to keep the clamp on the leaflet secure. However, a second wire may be implemented as a back-up if desired.

[0039] In other examples, the body of the catheter device can be formed of a composite material, such as carbon or glass-reinforced PEEK. The first clamp arm can then be connected to the body of the catheter device using a pin joint, the pin forming the axis of rotation of the first clamp arm. Similarly, when the second clamp arm includes an elastic metal sheet, the rotatable element of the arm can be formed by another pin joint located on the surface of the body of the catheter device. The pin joint mentioned here can be a rotary joint or an articulated joint, that is, it includes the interengaging features of a pin or cylindrical member connecting the member, and the pin forms the axis of rotation of the joint. The movement of the second clamp arm can then be controlled by one or more pull wires, as described above. When the second clamp arm includes a single wire as described above, a cavity can be formed to pass through the composite material to allow the leaflet motion inhibitor to enter and exit the catheter device.

[0040] Alternatively or additionally, the first gripper arm may be heat set into a "more than closed" configuration. This will allow the first gripper arm to grasp tissue toward the body of the device as well as toward the second gripper arm.

[0041] In order to form the first gripper arm and hinge integrally with the body of the catheter, the body of the catheter may include an outer tube, wherein the first gripper arm is formed as a hinged portion of the outer tube. Several forms of slits and / or patterns may be formed in the tubing to provide a weakened hinge section that allows the first gripper arm to bend without plastic deformation.

[0042] In an alternative arrangement, an articulated gripper arm may be used. In this case, the first gripper arm may be milled, in which case actuation may be done with a spring for closing and a wire for opening (or vice versa), or with two wires (one for opening and one for closing). A pulley cut into the device may be used to redirect the pulling force from the wire.

[0043] One or both of the gripping surfaces may be arranged to retain the leaflet by friction. For example, one or more of the gripping surfaces may use a material having a high coefficient of friction and / or the gripping surfaces may have a texture or surface profile for increasing friction, such as a ridged or sawtooth profile. The end of the leaflet anchor tube typically opens into one of the gripping surfaces. The leaflet anchor tube may take the form of a generally cylindrical channel that is sized to be slightly larger than the leaflet anchor in its folded configuration.

[0044] The leaflet anchor may be formed of a resilient material and arranged so that it assumes an unfolded configuration when no force is applied and is resiliently deformable to a folded configuration when constrained within the leaflet anchor tube, for example.Other possible features of the leaflet anchor are discussed at various points below.

[0045] Advantageously, the leaflet anchor may be placed into the leaflet from below (i.e., from the side where the papillary muscles are located). To facilitate the preferred placement of the leaflet anchor from below, the catheter device may be arranged so that the open end of the leaflet anchor tube is at the proximal end of the clamp device (the "upper" end when in the heart in the above defined orientation), and the leaflet anchor may be pushed out of a channel moving from the distal end toward the proximal end of the catheter device. Thus, the end of the first clamp arm may also have the end of the leaflet anchor tube, and this may be arranged to guide the leaflet anchor in a direction extending toward the proximal end of the catheter device. In some embodiments, the catheter device includes a U-shaped rod for deploying the leaflet anchor, as discussed further below.

[0046] In some examples, the second gripper arm can be cut out of the body of the catheter device in a similar manner as the first gripper arm, such as from a portion of the body at a side of the body opposite the first gripper arm. The second gripper arm can have a cut feature in its base to allow a tight bend to be pulled out of the device, and can also be thermoformed to increase stiffness.

[0047] In an example using a mechanical hinge for the first gripper arm, the catheter device body can be made from a resilient metal such as Nitinol, while the first gripper arm itself is milled from another separately formed stainless steel. Alternatively, the body can be milled with the gripper arm cut from a resilient metal, or the entire device can be milled or manufactured by additive manufacturing.

[0048] The leaflet anchor tube may be heat treated with a flat section on its inner end that extends beyond the rotational "center" of the first gripper arm. This may act as a lever for pulling the first gripper arm open.

[0049] The second clamp arm can be cut from a sheet of metal, such as nitinol, and placed in the body of the catheter device in an elastically deformed state. This deformation can be purely to allow the arm to take a smaller profile for insertion into the body, so that once it is in the body, it will expand into an undeformed state. Alternatively, for example, once the second clamp arm is in the body, some elastic deformation can be maintained so that it will hold itself in place by elastic force and / or so that it can automatically unfold by elastic unfolding when the first clamp arm is opened. The second clamp arm can be formed with a heat setting having, for example, a slight curve or a convex curve to increase rigidity and or provide a clamping surface. A corrugated or barbed edge can be provided to enhance the clamping strength of the clamping device. In addition, or alternatively, a slit can be placed on the surface of the second clamp arm to provide different flexural properties. In some examples, the hinge mechanism for the second clamp arm is formed in the main device by using two holes, wherein a pin is formed in the second clamp arm, and the pin fits into the hole. This can be assembled by inserting the second gripper arm with elastic deformation as described above, and by allowing the second gripper arm to fully or partially expand to a position where the pin engages the hole to form a hinge. A wire may be attached to the second gripper arm to move it up and down, or the wire may be one-way spring loaded and pulled the other way.

[0050] When the dual arm clamp of this aspect is combined with the second aspect and its flexible joint, then in one example, the two-part housing segment of the second aspect is made from a single tubing segment cut to the desired shape, the first clamp arm is disposed in the proximal portion of the two-part housing segment forming the body of the catheter device, and the first clamp arm is advantageously cut from the same tubing segment. In this way, many features of the catheter device can be formed from a single tubing segment, for example from laser cut Nitinol. Alternatively, the two-part housing segment of the second aspect is made from two parts connected with a hinge, as described above, and in this case, the catheter device can be formed from a combination of materials (possibly including composite materials).

[0051] Viewed from a second aspect, the invention provides a catheter device for implanting a leaflet anchor and a papillary anchor into a heart as part of a procedure for implanting a synthetic cable extending between the leaflet anchor and the papillary anchor, the catheter device comprising:

[0052] a two-part housing section extending from a distal end of the catheter device along the length of the catheter device toward a proximal end of the catheter device, the two-part housing section being arranged to be placed between a papillary muscle and a leaflet of the heart during use of the catheter device, and comprising a distal portion at the distal end of the catheter device and a proximal portion located proximally of the distal portion;

[0053] a leaflet anchor deployment mechanism at a proximal portion of the housing segment for deploying the leaflet anchor attached to the leaflet of the heart;

[0054] a papillary anchor deployment mechanism at the distal portion of the housing segment for deploying a papillary anchor attached to the papillary muscle, wherein the papillary anchor deployment mechanism is arranged to deploy the papillary anchor by moving the papillary anchor outwardly in a distal direction relative to the distal portion; and

[0055] A flexible joint is located between the proximal portion and the distal portion of the two-part housing section, wherein the flexible joint allows a centerline of the distal portion to be angled relative to a centerline of the proximal portion.

[0056] The device of this aspect provides a new method of inserting a papillary anchor that allows a physician to implant the leaflet and papillary anchor without having to move the device after first placing the leaflet anchor or after positioning the device in preparation for placement of the leaflet anchor / grasping the leaflet (in the latter case, the papillary anchor is placed first). Compared to the device described in WO2016 / 042022, the catheter does not have to be moved to a different orientation or position within the heart before placing the papillary anchor. Instead, the flexible joint allows the distal portion to be angled toward the papillary muscle region without the rest of the catheter device moving. The flexibility of the joint can also allow the distal end of the distal portion to be pushed more evenly against the papillary muscle, i.e., ensuring that it is pressed more evenly against the body tissue across the entire cross-section of the distal end. This in turn ensures effective implantation of the papillary anchor because it can engage with the body tissue around the entire cross-section.

[0057] The device thus reduces the risk of entanglement and minimizes the time required for the implantation procedure. A method of placing an anchor is described in WO2016 / 042022, but the design of the papillary anchor deployment mechanism and its housing requires greater care to ensure that all anchor pins engage well with body tissue. It should be noted here that in this document the term "pin" is used interchangeably with the term "hook" and in each case describes the same element of the anchor.

[0058] Alternatively, the flexible joint may also be extendable. Thus, a flexible and extendable joint may be present between the proximal portion and the distal portion of the two-part housing segment. The flexible and extendable joint may allow the distal portion to move away from the proximal portion via extension of the joint, thereby extending the distal end of the catheter device further into the heart. In this way, the device may be extended to move the distal portion of the housing segment together with the papillary anchor in a direction toward the papillary muscle region, while the remainder of the catheter device does not move. The elasticity of the flexible (and extendable) joint may act to avoid excessive forces on body tissue, reduce the risk of trauma during implantation, and help ensure uniform pressing forces on the extension and flexible mechanisms working in combination.

[0059] The nipple anchor may be comprised of a plurality of pins arranged to form a hook in the body tissue when the anchor moves away from the distal portion of the shell segment into the deployed configuration. In some examples, a nipple anchor similar to the design of WO2016 / 042022 may be used. In other examples, the nipple anchor may have other features as described below, such as slits along the pins. The proposed second aspect of the device may also be used with other types of anchors that need to be placed a certain distance apart, such as screw anchors or barbed anchors.

[0060] As described above, by adding a flexible joint between the two portions of the housing segment, a more reliable deployment and lower chance of entanglement can be achieved. The flexibility of the joint also helps the device to travel through bends in the catheter because it is divided into two shorter straight sections that can bend relative to each other, rather than one long rigid section. The flexible joint allows the centerline of the distal portion to be angled relative to the centerline of the proximal portion, and these centerlines can be aligned with the centerline of the catheter when the device is stationary. It should be understood that the device will have a prismatic shape, typically cylindrical, so the centerline can be along the center of the cross-section of the prism. During use of the device, the centerline of the proximal portion of the housing segment can remain aligned with the centerline of the adjacent portion of the catheter supporting the housing segment, while the centerline of the distal portion can be angled differently.

[0061] The optional feature of the extendable joint also allows the distal part to move away from the proximal part, thereby the distal end of the catheter device is further extended into the body / heart, and therefore it has the telescopic effect of the total length of the two-part housing section. In the case of using a flexible and extendable joint, this can have two separate mechanisms to provide required flexibility and extensibility. Therefore, the mechanism for bending between the two parts can be arranged, and the separate mechanism for extending by a certain form of telescopic effect. In this case, the telescopic effect can be arranged by a sliding sleeve, by a foldable or hinged structure, and / or by an elastic foldable structure. In other examples including exemplary embodiments shown herein, a flexible and extendable joint can have a single "flexible" part that provides flexibility and extension function. This can be, for example, a foldable and / or elastic foldable structure, for example a bellows arrangement (as having a flexible drinking straw) or a structure with one or more foldable coils and / or waveforms, for example a spiral spring or a group of parallel tortuous paths.

[0062] The two-part shell section can be formed by two tubular sections of any suitable material (i.e., medically appropriate material). Stainless steel or Nitinol can be used. In an alternative, a composite material, such as carbon fiber or glass fiber reinforced PEEK, can be used. The catheter device can be formed by a combination of such a material with materials of different parts of the device (selected according to the required properties of these parts). It is preferred to allow the passage of ultrasound and at the same time have sufficient strength, carbon reinforced PEEK meets these requirements well, and will also allow injection molding of the components, which reduces manufacturing costs. Fiber reinforced plastics are generally invisible on X-rays, so non-transmissive markers placed strategically in all components can be used to determine the position and orientation of the device components relative to each other on X-rays as supplementary information for ultrasound imaging.

[0063] In some exemplary embodiments, the flexible element is formed by providing a foldable form in the wall of a tube made of a flexible and elastic material (e.g., nitinol or another shape memory metal). Laser cutting can be used to provide the desired form. The extendable and flexible joint can be cut in any suitable pattern to achieve the desired functionality. For example, it can be formed as a regular (e.g., spiral) spring. The extendable and flexible joint can be cut asymmetrically to achieve the desired flexible pattern and asymmetrical force during contact between the distal end and the wall of the heart. Thin-walled silicone elements are possible alternatives to tubes cut into a foldable form. For example, a thin-walled silicone tube that can be stretched to many times its original length. In this case, the silicon tube portion can be connected to the clamp segment and the papillary anchoring segment via an appropriate support bracket.

[0064] The flexible and extendable joint can be extended during the process for inserting the papillary anchor, as discussed further below. It can also be extended independently or placed under compressive tension prior to insertion and then released (making the device longer, thereby pushing against the heart wall).

[0065] The flexible and extendable features may also be used alone, i.e., not directly in conjunction with placement of the leaflet anchors. Thus, the procedure may be divided into two stages, one for attaching the sutures to the leaflets and one for placement of the papillary anchors. When these steps are done separately, it may be advantageous to use a telescoping tube to provide all or part of the extendable functionality, as this approach may allow the device to be shorter.

[0066] The joint may have mechanical shielding inside and / or outside to prevent wires, cables or tissue from being pinched. This may be in the form of a flexible membrane that is stretched with the extendable joint, such as a thin sleeve located outside the joint. The membrane may be a silicone membrane fixed to the outside of the unit above and below the joint. For example, it may be fixed with an adhesive. Alternatively, a flexible layer of silicone (or other flexible material) may be overmolded onto the flexible joint to reduce the risk of pinching during joint movement. Fabric covering techniques similar to those used to cover esophageal stents or stent grafts may be applied to the joint.

[0067] In some examples using a flexible and extendable joint, when the flexible and extendable joint is compressed, the joint may be covered by a section of tubing that extends all the way to the distal end of the catheter device. This may be, for example, a thin wall Nitinol tube. This allows the extendable joint to be completely covered during its entire length of travel. The cover tube may reduce the amount of flex in the device, so additional flexible sections may be added just above where the cover tube is attached to the device, such as by cutting a pattern. The cover tube may be welded or glued to the body of the device.

[0068] The delivery handle used by the operator to control the device can be coupled in such a way that when the lower section of the device is extended, the artificial cable line is extended so as to keep the cable under proper tension regardless of how much the lower section of the device is extended. Additionally or alternatively, a constant tension device such as a constant force spring can be provided in the delivery handle to achieve proper tensioning of the cable and thus remove any slack in the cable line. Removing slack from the cable by keeping the line in a taut state can prevent entanglement between the cable itself and any other components of the device.

[0069] This flexible and extendable joint can be formed as a "spring configuration" that is extended by default, compressed, or somewhere in between to allow for different arrangements of movement / functionality. It can also be partially heat set stretched, which can allow for reduced material usage.

[0070] The leaflet anchor and / or leaflet anchor deployment mechanism may be similar to the leaflet anchor and / or leaflet anchor deployment mechanism of WO2016 / 042022.Alternatively or additionally, the leaflet anchor and leaflet anchor deployment mechanism may have features as described below.

[0071] The nipple anchor is housed within the distal portion of the housing segment prior to its deployment. The nipple anchor may have a similar cross-section to the distal portion of the housing segment. For example, both may have a tubular shape when the anchor is retained in the distal portion. As described above, the anchor may have a folded configuration and an unfolded configuration, allowing the pin of the anchor to form a hook within body tissue during deployment of the nipple anchor. The nipple anchor deployment mechanism may take a form similar to that of WO2016 / 042022, and / or it may have additional or alternative features as described below.

[0072] In one example, the nipple anchor deployment mechanism includes a first wire or rod for pushing the nipple anchor in a distal direction relative to the distal portion of the two-part housing section. There may additionally be a second wire or rod for releasing the nipple anchor from the nipple anchor deployment mechanism so as to disengage the nipple anchor from the catheter device after implanting the nipple anchor in the body tissue (i.e., tissue of the papillary muscle and / or tissue adjacent to the papillary muscle).

[0073] The nipple anchor may have a cable attached thereto and may include a locking mechanism, such as a locking ring as in WO2016 / 042022 and as discussed below, for clamping the cable when no force is applied to the locking mechanism. The locking ring is resiliently deformable to release the cable from the locking mechanism for adjusting the length of the cable. The nipple anchor deployment mechanism may include a locking ring retainer for retaining the locking ring in its resiliently deformed position, the nipple anchor deployment mechanism being arranged to selectively withdraw the locking ring retainer from the locking ring so that the cable can be locked in place after the nipple anchor is deployed and after any desired adjustment of the length of the cable is made. The locking ring retainer may have a Z-shape as described below.

[0074] The flexible joint may comprise a hinge element, for example wherein the distal portion of the two-part housing segment is coupled to the proximal portion via a pivot mechanism or via an elastically deformable element. For example, the two portions of the housing segment may be composite or metal components coupled together by a hinge element.

[0075] In some examples, the flexible joint is controlled via one or more wires (e.g., nitinol or stainless steel wire). There may be wires that allow the angle of the flexible joint to be controlled by pushing and / or pulling. There may be three wires distributed in the support section in the shell segment and / or attached to the flexible joint, for example to achieve complex movement, such as when the joint is also extendable. These wires can be arranged so that when one or more wires are pushed or pulled, the movement of the distal portion of the shell segment will be controlled. For example, they can change the angle or extension of the flexible and extendable joint. The three wires can be arranged to be used by pushing or releasing so as to extend the device to retrieve the placed nipple anchor while still keeping the leaflet in the clamp. The wires can also be arranged to angle the distal portion more perpendicular to the heart wall for more optimized placement of the nipple anchor.

[0076] In some examples, the hinge element may be controlled via one or more hinge pull wires. The hinge pull wires may be in the form of one or more of the above-mentioned wires. The hinge pull wires configured to control the hinge element may be arranged to be located inside the catheter device and / or pass through the front of the catheter device (wherein "front" refers to the side of the catheter device axis where the leaflet anchor deployment mechanism can be located). The hinge pull wires configured to control the hinge element may also be arranged so that they are radially offset from the central axis of the catheter device, that is, so that they are close to the wall of the catheter device rather than the central axis of the catheter device.

[0077] When the hinge pull wire configured to control the hinge element is arranged as described above, the hinge pull wire can be used as a deflection wire, that is, the hinge pull wire can be configured so that: when the distal portion of the two-part housing segment is angled relative to the proximal portion of the two-part housing segment by using the hinge pull wire, the hinge pull wire can deflect the device axis of the catheter device in the same direction as the direction in which the hinge element of the flexible joint is angled. This can have the effect of increasing the force acting on the heart wall during the deployment of the nipple anchor from the catheter device. During the operation of the hinge pull wire, the actuation of the hinge element and the deflection of the device axis can be sequential or simultaneous. For example, during the operation of the hinge pull wire, the device axis can be deflected while the hinge element is bent, or during the operation of the pull wire, first the hinge element can be bent and secondly the device axis can be deflected. In addition, when the hinge pull wire is actuated, the device axis of the catheter device can be turned in a target direction. This advantageously helps to ensure that the distal portion of the two-part housing segment is perpendicular to the target wall of the heart during the deployment of the nipple anchor.

[0078] In some examples, a flexible (and optionally extendable) joint is cut with a laser from an elastic tube (e.g., a Nitinol tube, which also serves as a structural component of the entire catheter device) so that the tube also forms the distal and proximal portions of the two-part housing section. Different types of patterns can be applied to the edge of the tube facing the tissue to achieve different friction and / or potential "hooks" to keep the device stable during implantation, one example being a wavy pattern edge or a flange with increased surface facing the tissue. To avoid pinching the new cable, a sheath can be implemented to cover the suture within the joint, wherein the suture sheath can be retracted / opened once placement of the anchor is confirmed.

[0079] An example of using the catheter device of the second aspect may include the following steps: (1) first placing the device close to the final placement position; (2) angling the flexible joint to move the distal portion toward the papillary muscle, and the wire / rod within the distal portion moves with the papillary anchor, for example due to friction between the papillary anchor (or papillary anchor push tube) and the inner surface of the distal portion of the shell segment; (3) the distal end of the distal portion meets body tissue, and when force is applied, the reaction force from the body tissue eventually exceeds the force holding the papillary anchor in place, at which point the tissue is flattened below the base of the device, thereby giving the greatest chance of correctly placing all pins in the tissue, and force can be applied to the anchor so that the ends of the pins are The distal end of the distal portion is then moved beyond to meet the body tissue, which can be accomplished by applying additional force on the anchor by a rod or wire, or advantageously, this can be accomplished by pre-tensioning the anchor, which is maintained by friction with the distal portion until the force from the body tissue on the distal portion changes the balance of forces sufficiently under friction so that the papillary anchor pops out (similar to a stapler); (4) the papillary anchor pin is folded and formed into a hook shape of the unconstrained papillary anchor to engage the body tissue, at which point the connection can be tested by the operator by pulling, and / or visually confirmed on X-ray and / or ultrasound; (5) if the connection is not satisfactory, the papillary anchor can be pulled back into the device and repositioned to try to improve the connection between the anchor and the body tissue. The same device can also implant a leaflet anchor, which can be performed after implanting the papillary anchor, or optionally before implanting the papillary anchor. During implantation of the papillary anchor, the leaflet anchor deployment mechanism can be used to clamp the leaflet with or without the leaflet anchor deployed.

[0080] It should be understood that the operation of the catheter device of the second aspect for implanting the nipple anchor can be compared to a stapler, as the force on the end of the device (when pushed) will drive the nipple anchor away from the end and into the material adjacent to the end similar to a stapler. In a typical example, once the device is in place and the leaflet is secured (e.g., in a holder as in WO2016 / 042022, or as discussed below), the nipple anchor can be placed, and if placement of the nipple anchor is approved, the leaflet anchor can be placed, if not, the leaflet can be separated and the nipple anchor retracted for re-placement. The flexible joint in the center of the device also improves movement through the catheter, particularly through arcs, as it can more easily pass through curves as two shorter components connected to the flexible joint.

[0081] In some examples, actuation of the leaflet anchors can be coupled to papillary anchor deployment, meaning that the leaflets and papillary anchors can be deployed at least partially simultaneously. This can make the procedure easier and / or faster.

[0082] From a third aspect, the present invention provides an anchor system, which includes an anchor for implantation in body tissue to hold a line, the anchor including a plurality of hooks for engaging with body tissue and having a folded configuration and an unfolded configuration, wherein the anchor is made of an elastic material so that it can be elastically deformed into the folded configuration by applying a restraining force, and will return to the unfolded configuration when the restraining force is not applied, wherein the end of each of the hooks includes a pointed tip, and wherein the pointed tip is formed to bend toward the central axis of the anchor when the anchor is in the folded configuration.

[0083] It should be understood that for hooks that engage with body tissue, the tip of each hook must be able to pierce the target body tissue. Therefore, the end of the tip is generally sharp and / or pointed. By requiring the tip of the hook to bend toward the central axis of the anchor when the anchor is in the folded configuration, that is, the end of the tip is spaced inwardly at some other part of the hook, the end of the tip is advantageously not in contact with the inner surface of the container device that provides the restraining force that elastically deforms the anchor. For example, if the container device that constrains the anchor in the folded configuration is a tubular device, the tip will bend away from the inner surface of the tubular device so that the end of the tip does not contact the inner surface. On the contrary, the smoother part of the hook will be tangential to the inner surface and is the contact point between the hook of the anchor and the container device. Therefore, in the folded configuration, the outermost part of the anchor can be the part of the hook that is spaced from the end of the tip of the hook, and the tip is located inside these outermost parts and extends toward the central axis of the anchor. Therefore, the tip of each hook cannot scrape and / or scratch the inner wall of the container device that constrains the anchor. This prevents damage to the container device and avoids the risk of producing scrapings of container tube material that may be undesirably deposited in the area of ​​the target body tissue. Although small deposits of material may appear negligible, scrapings may cause bleeding and / or may cause embolism, which may lead to a stroke.

[0084] The anchor may be made of a resilient metal, such as Nitinol or stainless steel, while the containment device may be made of a composite material, such as a material comprising a matrix with reinforcing fibers or particles, such as carbon reinforced (CRF) PEEK. It should be understood that the metal of the anchor may easily damage the composite material of the containment device.

[0085] The anchor system may comprise the container means together with the anchor. Thus, the anchor system may comprise a container means holding the anchor in a folded configuration, wherein the tip of the anchor is bent inwardly away from the container means. The container means may provide a constraint around the outer circumference of the folded configuration of the anchor, and it may be a tubular container means as discussed above, such as a circular tube.

[0086] Another advantage created by having the ends bent toward the central axis of the anchor when the anchor is in the folded configuration is that less force is required to eject the anchor from the containment device during implantation in body tissue. By having a smooth point of contact between the anchor and the inner surface of the containment device, the coefficient of friction between the anchor and the device is reduced. Thus, less force is required to eject the anchor during implantation.

[0087] When the anchor is in a folded configuration, the curvature of the tips towards the central axis of the anchor may be described as at least one of, for example, a reverse bend, an opposite bend or an S-shaped bend. In other words, in the folded configuration, the hook may include a first curved portion extending towards the central axis of the anchor. The hook and the tip may then bend away from the central axis of the anchor in a second curved portion before the tip is formed to bend back towards the central axis of the anchor in a third curved portion. Thus, the curvature of the hooks may be such that they have at least one inflection point.

[0088] Advantageously, the curvature of the anchor helps pull the anchor into body tissue during implantation and thus reduces the force required to push the anchor during implantation. The curvature of the anchor provides a "spring-back" force as the anchor unfolds from its folded configuration to its unfolded configuration, wherein the curvature of the hook of the anchor helps pull the anchor through body tissue. Anchors having hooks that do not bend back toward the central axis of the anchor when in the folded configuration do not exhibit this advantageous effect.

[0089] Unless a large amount of axial force is applied to the anchor during implantation, anchors having hooks that do not bend back toward the central axis when in the folded configuration tend to bend back immediately to their unfolded configuration without penetrating the tissue any particular distance. However, anchors having hooks whose tips are formed to bend toward the central axis will tend to penetrate the body tissue a greater distance before the tips begin to bend outward from the central axis when the tips are moved to their unfolded configuration. Therefore, a reduced axial force needs to be applied to the anchor from the containment device to cause initial penetration of the anchor, and in some cases, this may be forceless in the case of deployment of the anchor for pulling it into the tissue as long as the distal end of the containment device is in contact with the surface of the body tissue. The resilient force of the anchor produced by the inward bending of the tips promotes the trajectory of the hooks of the anchor, which cause the anchor to move along a deeper curve into the tissue, thereby causing the described pulling effect.

[0090] When the anchor is in the unfolded configuration, the hook may extend away from the central axis of the anchor in a grappling hook type shape. Thus, the anchor may be configured such that when moving from the folded configuration to the unfolded configuration, the tip moves outwardly away from the central axis of the anchor. In the unfolded configuration, the hooks may have a curvature with at least one inflection point, for example the direction of curvature of the hook may be reversed at the tip. Thus, the unfolded configuration of the hook may have a first curved portion having a first direction of curvature extending along most of the length of the hook, followed by a second curved portion having a direction of curvature opposite to that at the tip of the hook. This form may be used to ensure that when folded into the folded configuration, the tip will bend inwardly towards the central axis as described above.

[0091] The curvature of the hook of the anchor in its unfolded configuration as described above advantageously increases the planar extent of the anchor and therefore increases the surface area covered by the anchor when deployed. When the anchor, once implanted, covers a larger surface area of ​​tissue, the forces of the anchor acting on the tissue are likewise spread out over a larger area. This reduces the strain on the body tissue into which the anchor is implanted. This is particularly advantageous when implanting the anchor into lower mass or weaker body tissue.

[0092] The anchor may include a body portion from which the hooks extend. For example, the body portion may include a tubular wall from which the hooks extend (e.g., from the end of the tubular wall). Thus, in the case where the curve is in a folded configuration, a first curved portion may extend from the tubular wall, followed by other curved portions that further extend from the tubular wall. In an exemplary embodiment, the hooks extend from the body portion with a smooth curvature in both the unfolded configuration and the folded configuration. In this case, there is no step change in curvature at or near the point where the hook engages the body portion (e.g., the tubular wall). The hooks may extend from the body portion with an initial curve having a tangent that is aligned with the axial extent of the body portion in both the unfolded configuration and the folded configuration. The curvature of the hook may not include a step change at all, such that it is always a continuous curve without sharp corners.

[0093] The curvature of these tips can result in the end of each hook being configured to be perpendicular to the surface of the body tissue in a folded configuration, that is, when the anchor is implanted in the body tissue, the ends of these tips can be pressed into the body tissue so as to initially pierce the body tissue in a direction perpendicular to the surface of the body tissue. Typically, this will involve at least the distal portion of the tip being parallel to the longitudinal axis of the anchor and / or parallel to the direction of movement of the anchor when implanted. Advantageously, by having the ends of the hooks perpendicular to the body tissue, less force is required to implant the anchor into the body tissue. This is because the force that pushes the anchor into the tissue is being transferred to the ends of the tips (where the initial implantation will occur) has a higher conversion. In addition, by requiring the ends of the hooks to be perpendicular to the body tissue in which the anchor is to be implanted, alignment of the anchor with the body tissue will be easier.

[0094] Similarly, the curvature of the tips can result in the tip of each hook being configured to be angled with the surface of the body tissue in the folded configuration, i.e., when the anchor is implanted in the body tissue, the end of the tip can be pressed into the body tissue to initially pierce the body tissue in a direction that is angled inwardly with the central axis of the anchor / at an acute angle with the surface of the body tissue. Thus, when in the folded configuration, the tip can be bent toward the central axis, and at least the end of the tip can extend diagonally toward the central axis. The angle of curvature of the tip can be any value in the range of 0 to 30 degrees with the normal to the surface of the body tissue in which the anchor is to be implanted. In various embodiments, the curvature of the tip can take values ​​ranging from 0 to 5 degrees, 0 to 10 degrees, 0 to 15 degrees, 0 to 20 degrees, 0 to 25 degrees, or 5 to 15 degrees. Advantageously, by slightly angling the tip of the anchor with the body tissue, less axial force is required to fully implant the anchor in the body tissue. The force can be applied to the anchor by the anchor container tube, which includes a plurality of wires and / or rods for applying the axial force. This is because the resilient force provided by the hook of the anchor helps pull the anchor into the body tissue. When initially implanted in body tissue, the resilient force exhibited by the hook of the anchor increases according to the degree to which the tip of the anchor bends inwardly.

[0095] Thus, it will be appreciated that the angle of the tip to the surface of the body tissue into which the anchor is to be implanted may be considered to reduce the force required to fully implant the anchor into the body tissue.

[0096] The tip of the hook may include a tapered section extending to a pointed tip for piercing body tissue. The tips may also include a widened section before the tapered section, wherein the widened section is wider than the front portion of the hooks. The shape of the tip of each hook may be a teardrop, leaf and / or petal shape. That is, the tip may include a generally oval shape including a pointed tip for engaging body tissue. The shape of the tip may be such that the widest portion of the tip is wider than the width of the front portion of the hook, wherein the point has a width narrower than the width of the hook.

[0097] The shape of the tip such that the tip is generally wider than the rest of the hook can advantageously help strengthen the engagement of the anchor with the body tissue. When tissue regrowth occurs around an implanted anchor, tissue can regrow around the hook extending through the body tissue. Because the widest portion of the tip of each hook is wider than the width of the leading portion of the hook, greater force is required to remove the implanted anchor after tissue regrowth has occurred, while the shape of the tip itself forms a further anchoring feature.

[0098] It will be appreciated that the anchor of this aspect may be used as a leaflet anchor or a papillary anchor.

[0099] The anchor may further include: the hooks are formed with a plurality of openings along their length. By adding openings in the anchor hooks, hooks of greater width may be used, thereby increasing holding strength while still allowing for significant deformation between the folded and unfolded configurations without any plastic deformation. The increased surface area of ​​the larger width hooks also aids in the distribution of deployment forces. The openings may also enhance healing by allowing tissue to grow between the slits, forming a more reliable connection between the anchor and the tissue over time, rather than the tissue forming a "protective sheath" that can be more easily pulled out, as is the case with solid hooks.

[0100] Advantages arise if the anchor can releasably hold a line such as a cable, and so the anchor may include a locking mechanism for clamping the line when no force is applied, and being resiliently deformable to release the line from the locking mechanism to adjust the length of the line. This may use a locking ring as described below.

[0101] In some examples, the opening in the hook includes a plurality of holes (e.g., a plurality of holes having a diameter of approximately 0.2-0.4 mm) that are connected to a suture, wherein a single length of the suture passes through several of the plurality of holes, or through all of the plurality of holes. The suture may be knotted at each hole. The suture may be, for example, a Dyneema suture (or other similar suture, such as Dacron). Elastic materials such as Nitinol may be susceptible to fatigue fracture during high cyclic loads (including cyclic loads that would be generated by a beating heart). By using a suture that passes through a plurality of holes, the failsafe of the anchor pin may be increased. If the hook of the anchor breaks, the anchor is still held together by the suture, which reduces the risk of embolism while also providing additional time for tissue ingrowth. Therefore, even if the anchor breaks early, it will not embolize, and it will still be able to maintain some force because even if one or more hooks break, the expanded anchor will be too large to be pulled through its entry hole. Using sutures in this manner will also form more "openings" for tissue growth to pass through. The plurality of holes may be circular holes made in addition to other openings in the hooks, such as circular holes made in addition to the slits as discussed below.

[0102] As an alternative to using sutures passed through the opening, the anchor may include an overmold that may be placed around the entire anchor, but it is possible that the sharp tip of the hook is not included. A suitable material for such an overmold is ePTFE. Another alternative is to use a woven fabric bag that surrounds the anchor. Both of these solutions will prevent the anchor from embolizing if there is a break in the anchor. Using ePTFE also provides the added benefit of tissue ingrowth.

[0103] The anchor can be formed from a tube that is cut to provide tines extending from one end of the tube, which are then bent and heat set to form the hooks and tips. The openings can be cut into the tines before or after the tines are bent, but typically before the tines are bent so that there is only one cutting stage. An additional benefit of using an opening associated with this construction is that a small diameter pipe becomes more flexible with an opening in the center because the arc of the pipe is divided into two smaller arcs. As a result, the wider portion of the narrow tube can be safely used to make the tines, which again provide additional strength. As a result of the increased retention and increased flexibility, the anchor hooks are subject to less fatigue loads, which in turn allows the implant to last longer.

[0104] These openings can be formed as a series of holes, or as slits that extend along the length of the tines and thus along the curve of the hook. The advantage of using slits is that each hook consists of two "legs", which means that a break in one "leg" does not mean that it will embolize, and the anchor is still held in place by the other leg. At the same time, the new "V" shaped legs will grow into the tissue more effectively than a straight "broken" hook without any slits or other openings, further reducing the risk of embolism.

[0105] These openings may include multiple smaller slits in rows or with different types of patterns (e.g., zigzag, barbed, or wavy patterns). Along the length of the hook, small holes with different patterns may be formed, either instead of or in addition to the slits. This may provide additional retention as tissue grows through the holes. It may also allow sutures to be passed through the hooks for added security in the event of a break as described above. The slits may also extend beyond the ends of the hooks, where they engage into the base of the anchor, which may be a tubular portion as discussed above, thereby making the base more flexible as well. In some examples, the slits may be cut as a single laser track. Circular openings may be added at the ends of such cuts to prevent high strain points.

[0106] In one example, the anchor is cut from a tube made of a resilient metal such as nitinol or stainless steel. Laser cutting can be used. This can involve cutting tines as described above, which can be heat-set into a curve. The anchor can be heat treated and / or electropolished. Before the anchor is electropolished, beveled edges can be introduced into certain portions of the anchor. The openings can include barbed or wavy profiles along the edges of the openings (e.g., along the edges of the slits). When slits are used, the slotted hooks can be heat-set into a configuration in which they have an increased distance when deployed. Then, when the pin is straight (when the barbs face each other), the barb profile can be hidden. In this example, when the anchor becomes a non-constrained configuration, the slits move apart and the barb profile is engaged.

[0107] In various aspects, the invention extends to the use of the above-described catheter devices and anchors, in particular the use of these devices in the process of implanting an artificial cable into the heart. In addition, the invention extends to the manufacture of the above-described catheter devices and anchors, including the various method steps described above, such as laser cutting from a tube. For any anchor or other laser cut part discussed herein, a beveled edge may be introduced prior to electropolishing the laser cut part (e.g., anchor). The features of the third aspect and other optional features discussed above may be combined with the other aspects discussed above and below, so that the anchors of these other aspects have hooks formed according to the third aspect.

[0108] Viewed from a fourth aspect, the present invention provides a catheter device for implanting an anchor into body tissue to attach a line to the body tissue, the catheter device comprising:

[0109] a housing section extending from a distal end of the catheter device along a length of the catheter device toward a proximal end of the catheter device, the housing section comprising a distal portion at the distal end of the catheter device and a proximal portion located proximally of the distal portion;

[0110] an anchor deployment mechanism at the distal portion of the housing segment for deploying an anchor attached to the body tissue, wherein the anchor deployment mechanism is arranged to deploy the anchor from a stowed position of the anchor by moving the anchor outwardly in the distal direction relative to the distal portion;

[0111] the anchor being retained in its stowed position by the anchor deployment mechanism in the distal portion prior to deployment, wherein the anchor is for implantation in the body tissue to retain a line, the anchor comprising a plurality of hooks for engagement with the body tissue and having a folded position and an unfolded position, wherein the anchor is made of an elastic material such that the hooks can be elastically deformed to the folded position by application of a restraining force and will return to the unfolded position when the restraining force is not applied, and wherein the hooks are retained in the folded position when the anchor is in the stowed position within the distal portion;

[0112] wherein the distal portion of the housing has a non-circular shape for engaging with a corresponding non-circular form of the anchor and / or the anchor deployment mechanism such that: when the anchor is retained in the distal portion, movement of the anchor is limited relative to rotation of the anchor about the longitudinal axis of the distal portion due to the engagement between the non-circular shape and the non-circular form.

[0113] By this arrangement, the interaction of the non-circular shape of the distal portion with the non-circular form of the anchor or anchor deployment mechanism ensures that the anchor has the desired orientation when it is in the distal portion. At least with reference to a certain amount of force that the anchor and the catheter device may be exposed to during normal use, the rotation of the anchor is limited and advantageously can be prevented. Typically, constraints are provided by the interlocking of the non-circular form in the non-circular shape, and its design tolerances meet the appropriate manufacturing technology, materials and design principles. These non-circular elements can take any shape that is not circular. Some options are discussed below. The non-circular nature of the shape / form can be achieved by modifying the circular form, such as by adapting it to a keyed joint, where the key or keyway contributes to the non-circular portion of the shape. The catheter device can be used to implant the anchor in the heart, and the anchor can be a papillary anchor for implantation in the papillary muscle, wherein the line is, for example, an artificial cable line, such as a line used to repair the heart in the case of chordae tendineae failure. Therefore, the rotation constraint can be designed to resist the force that may attempt to rotate the anchor undesirably during the use of the catheter device in the heart, or the force generated when retrieving the delivered anchor to find the correct orientation of the anchor before retraction. Further features of the catheter device for implanting an anchor in the heart will be discussed below, and it will be appreciated that the catheter device of the fourth aspect may be combined with the other features set out below.

[0114] The non-circular shape can be a shape formed around a recess for accommodating the anchor and the anchor deployment mechanism within the interior of the distal portion, wherein the anchor is in the stowed position. The non-circular shape can include a funnel-shaped shape at its distal end. This can allow the guided engagement of the anchor and the anchor deployment mechanism. For example, the non-circular shape can gradually widen as it approaches the distal end of the distal portion. The outer shape of the distal portion can be a different shape, for example it can be a tubular shape with a form similar to the outer portion of the rest of the catheter device (such as a circular tube). Advantageously, by using an outer shape different from the inner non-circular shape, the thickness of the wall of the distal portion can vary. Alternatively or additionally, the non-circular shape within the interior of the distal portion can be placed eccentrically, i.e., off-center, so as to produce a variable thickness of the wall of the distal portion. The thicker section of the wall can better accommodate other features of the catheter device, such as a cable channel. By utilizing the varying thickness in this way, such features can be increased without increasing the overall width / diameter of the catheter device. Therefore, in some examples, the thicker section of the wall of the distal portion includes a cable channel. The cable channel may be a slit along the length of the distal portion, which may also effectively function to increase the elasticity of the distal portion, thereby allowing the distal portion to flex as it receives the anchor and anchor deployment mechanism.

[0115] The anchor may include a locking mechanism having an elastically deformable locking segment, as discussed further below. Alternatively, the locking mechanism may take another form, for example, via a plurality of parts that move in a rotational or linear direction, so as to capture or constrain the movement of the line, for example, by an interference fit. The locking mechanism may be used to lock the line in place after the anchor is deployed. The anchor deployment mechanism may be arranged to keep the locking segment in a deformed position when the anchor is retracted in the distal portion, and advantageously, when the locking segment is in the deformed position, the locking segment may take a non-circular form, wherein this non-circular form engages with a portion of the non-circular shape of the distal portion of the catheter device. Therefore, the portion of the non-circular shape of the distal portion of the catheter device may be arranged to engage with an anchor having a deformed locking segment, wherein, when the anchor is in the distal portion, the various non-circular elements engage with each other, thereby limiting the rotation of the anchor in the distal portion. In one example, the locking segment is tubular when it is not deformed and can be aligned with the tubular wall of the anchor, and the deformation of the locking segment causes it to move out of alignment with the tubular wall of the anchor and thus form a non-circular form for engaging with the associated portion of the non-circular shape of the distal portion. The anchor can have a circular tubular wall, and the deformed locking segment has a non-circular form of an oval shape, wherein a portion of the locking segment protrudes outwardly beyond the tubular wall of the anchor. In this case, the distal portion of the catheter segment can have a corresponding oval cross-section, or some other non-circular cross-section, to complement the cross-section of the anchor with the deformed locking segment. Therefore, the distal portion can include a first tubular recess having this non-circular cross-section, wherein the first tubular recess is formed to abut against a second tubular recess to accommodate a portion of the anchor wall located proximal to the locking segment. Therefore, the second tubular recess can have a circular tubular form, which is arranged to fit concentrically around the anchor wall proximal to the locking segment. Other optional features of the locking mechanism of the anchor are discussed below.

[0116] The distal end of the anchor and / or the distal portion may be arranged to elastically deform during engagement of the anchor with the distal portion so as to allow guided engagement. Engagement of the anchor may thus be accomplished by the ability of the anchor and / or the distal end to handle some misalignment by elastic flexure. The anchor may be inherently flexible due to its formation from an elastic material. The distal end may be adapted to allow some degree of flexure, for example by using a slit extending from the tip along the length of the distal end in a proximal direction.

[0117] The anchor deployment mechanism may include an adjustment housing that holds the anchor during deployment and facilitates adjustment of a line attached to the anchor. The adjustment housing may also include a cutter for cutting the line when the anchor has been successfully deployed in a desired position, wherein the line is adjusted to an appropriate length. In some examples, the exterior of the adjustment housing has a non-circular form, and a portion of the non-circular shape of the distal portion of the catheter device may be arranged to engage with the exterior of the adjustment housing, wherein corresponding non-circular elements engage with each other, thereby limiting the rotation of the adjustment housing, and thus helping to prevent the anchor from rotating due to the anchor being attached to the adjustment housing when the anchor is in the distal portion. The exterior of the adjustment housing may have a non-circular form at its proximal end (i.e., opposite to the distal end of the adjustment housing that is coupled to the anchor), wherein the distal portion of the catheter device has a shape for receiving the non-circular form. In this case, the proximal end of the adjustment housing may advantageously have a tapered shape, such as via a curved, chamfered or inclined edge, so as to allow a smooth and guided engagement of the proximal end with a corresponding portion of the non-circular form of the distal portion.

[0118] The shaft can accommodate the cutter (and the wire for operating the cutter) and the adjustment housing, and the shaft can be composed of two cavities: a cable (i.e., wire) cavity and a cutter wire cavity. The structure can be reinforced with a braid around the cable cavity. The braid can include a laser-cut hypotube, which increases the tensile and compressive strength of the shaft. The laser-cut hypotube can be welded directly on the head of the cutter. This ensures a strong bond between the cutter and the laser-cut hypotube, which allows the papillary anchor to be retrieved more reliably when the anchor needs to be adjusted and / or re-expanded. The braided composite conduit can be arranged outside the laser-cut hypotube to form a wire cavity. Kevlar wire or a wire of similar material can be arranged along the length of the shaft to increase the tensile strength of the shaft. The components and conduits arranged in the shaft can be embedded in a soft polymer, including but not limited to Pebax (e.g., by Pebax reflux), to allow sufficient flexibility of the shaft. The composite conduit can also be anchored in the distal end to prevent the conduit from being torn out of the soft polymer during the actuation of the cutter wire. The composite tubing may be anchored in the distal end with, for example, a flat ribbon coil, a stainless steel hypotube loop, or a collar.

[0119] The anchor and the adjustment housing can be arranged to engage with each other in the required orientation and prevent relative rotation. In this article, as mentioned above, the rotation is limited in the torsion direction along the axis of the catheter device, that is, the purpose is to correctly orient the anchor relative to the rotation around the longitudinal axis of the catheter device. However, it is advantageous to allow some relative rotation during the engagement of the anchor and the adjustment housing to ensure correct alignment without the risk of getting stuck. Therefore, the anchor and the adjustment housing can each have a circular portion for concentric engagement with each other, which includes a key joint to ensure correct alignment during the concentric arrangement. Therefore, one of the anchor and the adjustment housing can include a key feature, and the other includes a keyway for accommodating the key feature. The funnel-shaped / conical shape at the beginning of the keyway can be used to allow some misalignment and guided rotation before the key feature engages with the keyway.

[0120] The distal portion may have a non-circular shape that is arranged to engage with both the non-circular form of the anchor (such as the deformed locking segment discussed above) and the non-circular form of the adjustment housing (such as the outer portion discussed above). Thus, the non-circular shape of the distal portion may be a complex shape having a first portion for engaging with the anchor and a second portion for engaging with the adjustment housing. This may have additional advantages over using each element alone, as both engagements contribute to limiting rotation of the anchor within the distal portion. The two engagements combined may also have additional advantages through different features of the parts involved, such as different degrees of stiffness of the anchor compared to the adjustment housing (where the anchor is more easily elastically deformed); and / or a greater degree of flexibility during the mating of the non-circular shape and the non-circular form, such as by a greater difference in the size of the non-circular form of the distal portion fitting around the anchor than the non-circular form of the distal portion fitting around the adjustment housing and / or greater flexibility of the distal end of the distal portion, such as by using a slit as described above.

[0121] In some examples, the anchor is formed of an elastic material having a relatively flexible configuration, such as the anchor described further below, and the anchor is more easily elastically deformed than the adjustment housing, which may include a solid portion having a less flexible configuration, and / or may be formed of a less elastic material. For example, the anchor may have a relatively thin wall formed of a flexible metal (e.g., Nitinol), and the adjustment housing may be a solid shape, and / or have a thicker wall formed of a rigid material (e.g., stainless steel, a polymer material, or a composite material (e.g., CRF PEEK)). Thus, during reengagement of the anchor with the distal portion, engagement of the non-circular form of the anchor with the associated portion of the non-circular shape of the distal portion may be accomplished by elastic deformation of the distal end of the anchor and / or the distal portion to cope with relatively high degrees of rotational misalignment, while reengagement of the adjustment housing with the distal portion is reengagement of the non-circular form of the adjustment housing with the associated portion of the non-circular shape of the distal portion.

[0122] It may be desirable to move the anchor back from an unfolded configuration to a folded, stowed configuration during use, for example, if initial deployment does not provide a sufficiently secure connection between the anchor and body tissue. The catheter device may be arranged to facilitate reengagement of the anchor and the anchor deployment mechanism with the distal portion by firstly allowing reengagement of the anchor with the distal portion to correct relatively large rotational misalignments via the non-circular form of the anchor and / or the elasticity of the distal portion of the housing, and secondly allowing the exterior of the adjustment housing to reengage with the distal portion to apply a greater constraint to prevent rotation of the anchor within the distal portion due to the more rigid form of the adjustment housing. A first portion of the non-circular shape of the distal portion of the catheter device may extend a first distance in the distal direction from the fully stowed position of the anchor toward the distal end of the device. A second portion of the non-circular shape of the distal portion of the catheter device may extend a second distance in the distal direction from the fully stowed position of the adjustment housing toward the distal end of the device. To facilitate the above two-stage reengagement process, the first distance may be greater than the second distance, so that the first portion is greater than the second distance by a third distance. In an exemplary arrangement, the first distance may be in the range of 4-8 mm and the second distance may be in the range of 2-5 mm.

[0123] Thus, the anchor can be resiliently engaged with the distal portion at the third distance, thereby providing some correction to the alignment of the rotational orientation of the anchor before the adjustment housing engages the second portion of the distal portion at the second distance. When the adjustment housing engages the second portion of the distal portion at the second distance, the anchor is further advanced along the first distance, remaining engaged with the non-circular shaped first portion of the distal portion.

[0124] The adjustment housing may form an anchor holder that is connected to the anchor when the anchor is stowed and during deployment, and releases the anchor after the anchor is successfully deployed. The exterior of the anchor holder may have a non-circular form, and this may provide the non-circular form of the adjustment housing discussed above for engagement with the distal portion. The anchor holder may be provided in two parts that interlock, relative rotation between the two parts being prevented by corresponding non-circular shapes, which may include flat surfaces for correct alignment. The two parts of the anchor holder may include a piston for engaging with the anchor and a piston housing for retaining the piston, the piston being actuable to slide relative to the piston housing.

[0125] The piston may comprise a piston wedge for engaging with a deformable element of the anchor, which is advantageously a locking segment as described above. The piston wedge may be a wedge-shaped segment at the distal end of the piston. The wedge-shaped segment advantageously facilitates engagement with the locking segment and likewise disengages from the locking segment due to the shape of the locking segment. The piston wedge may be arranged to be pushed between the locking segment and the wall of the anchor to elastically deform the locking segment, advantageously forming a non-circular form of the locking segment and opening the locking segment to allow adjustment of the line. In this case, the piston wedge engages with the locking segment when the anchor is in the stowed position. The piston wedge may be a two-legged fork with an opening that allows the pipeline to pass between the two legs (tines) of the fork.

[0126] The piston wedge may engage with the locking segment without contacting any other wall of the nipple anchor. Thus, the anchor holder and anchor may be arranged such that when the piston wedge is engaged, it is spaced apart from the wall of the anchor. By advantageously requiring the piston wedge to contact the locking segment of the anchor alone and not any other wall of the anchor, the piston wedge is subject to less friction from the anchor. In this way, during deployment of the anchor from the catheter device, the anchor may be deployed without the piston wedge moving with the anchor, thereby ensuring the locking of the locking segment. The placement of the piston in the anchor holder may act as a cantilever that prevents the piston wedge from being pulled towards the wall of the anchor due to the elastic force of the locking segment. The piston and therefore the piston wedge may be made of a suitably rigid material so that the piston wedge does not bend due to the reaction force generated by the cantilever action of the piston and the force exerted on the piston wedge by the locking segment acting in the opposite direction.

[0127] The piston may include a cutter of the adjustment housing, wherein this cutter is arranged to cut the line when the piston is withdrawn from the anchor. The cutter on the piston may be a cutting surface arranged to interact with a surface of the piston housing so as to cut the line, for example via a shearing action. Thus, in the case of a piston wedge, when the locking segment returns to its undeformed position and clamps the rope to the anchor wall, the retraction of the piston may allow the line to be locked in place at the anchor while the line is simultaneously cut by the cutter. In this way, once the anchor is correctly placed and the length of the line is as desired, the piston facilitates the adjustment and cutting process.

[0128] An inner cam may be provided to assist in holding the anchor locking segment in an open position. The inner cam may have an unexpanded configuration, in which the cam fits inside the locking segment in an undeformed state of the locking segment, and an expanded configuration, in which the cam fits inside the locking segment in a deformed state, i.e. the non-circular form discussed above. The cam may have an opening at its center, which is wider in the expanded configuration than in the unexpanded configuration. The piston may be provided with a cam wedge, which is used to push the opening of the cam to the wider state and thereby expand the cam. In addition to the piston wedge discussed above, a cam wedge may be provided so that a single piston has a forked form at its distal end, wherein at least one tine of the fork provides a cam wedge and at least one tine of the fork provides a piston wedge. The cam may be arranged to assist in opening the locking segment, and where present, it may also be used to secure the anchor to the adjustment conduit. The cam may be held in place by a cam retainer on the adjustment housing.

[0129] The catheter device may include a mechanism for controlling the movement of the adjustment housing relative to the distal portion, such as for pushing the adjustment housing and the anchor outwardly from the distal portion in a distal direction to deploy the anchor. The mechanism may include an adjustment catheter located within the housing of the catheter device, wherein the adjustment catheter may be moved forward or backward along the length of the catheter device to advance or retract the adjustment housing. Movement of the adjustment housing may be controlled using wires and / or rods, wherein movement is performed manually or computer controlled via a control system arranged to be placed outside the body.

[0130] The catheter device may include a mechanism for controlling the movement of the piston relative to the piston housing. This may include a line and / or rod of a suitable type. The mechanism may be arranged to slide the piston outward from the piston housing so that the anchor is moved away from the piston housing. The mechanism may further be arranged to pull the piston back into the piston housing so that the piston is disengaged from the anchor or the anchor is pulled back toward the piston housing together with the piston. It should be understood that in order to complete the deployment of the anchor after the line has been properly placed and adjusted, the piston should be withdrawn from the anchor to thereby disengage, such as by removing the wedge from the locking segment in the presence of the locking segment. However, if it is determined that the anchor is not correctly placed, the user may decide to pull the anchor back toward the piston housing so that the anchor is subsequently pulled back into the distal portion together with the adjusting housing, thereby withdrawing the anchor from the body tissue and folding the hook back to the folded stowed position.

[0131] In order to prevent the cutter from exceeding its desired range of motion, the cutter can be equipped with two stop features arranged at the upper and lower ends of the cutter. In order to prevent the cutter from moving further than its upper position in the housing, the cutter wire can pass through the housing and / or the cutter to stop the cutter in the upper position. Even if the cutter wire breaks, since the cutter and the wire attached to the cutter to operate it are both contained in the housing, the cutter and the wire attached to the cutter to operate it cannot be detached from the upper end of the housing. In order to prevent the cutter from moving further than its lower position in the housing, a cam or an inner cam can be used as a lower position stop feature.

[0132] The adjustment housing can include a latch, which is used to engage with the housing section of the catheter device to prevent the adjustment housing from moving relative to the catheter device, and this can be used to provide a fastened state in which the anchor cannot be released. When the catheter device is turned to the deployment position, this safe state can be beneficial, such as being turned through a blood vessel to reach the heart as in the following example. The latch can pivot around an axis extending along the longitudinal axis of the catheter device so as to allow the latch to swing into engagement and disengagement with the housing section, such as engaging in a recess or groove formed in the housing section. A line or rod for actuating the latch can be included, such as a line (preventing the latch from moving to maintain a fixed state until the line is removed). The latch can be elastic and biased toward the disengagement position so that when the line is removed and the latch is released, the latch moves to the disengagement position under the influence of a spring force.

[0133] In some examples, the anchor is provided with a locking mechanism that clamps the cable when no force is applied and can be elastically deformed to release the cable for adjusting the length of the cable during implantation. As described above, the locking mechanism may include an elastically deformable locking segment. The locking segment may be formed in the wall of the anchor and separated from the wall by one or more slits. The anchor may be arranged so that: when no force is applied, the slits are closed without gaps or with relatively narrow gaps to clamp the wire, and when appropriate force is applied to the locking segment and / or the wall, the locking segment and / or the wall will elastically deform to widen the opening provided by the slit so that the wire is released. The anchor may have a tubular body section, in which case the locking segment may be formed in the wall of the tube. The locking segment may be a band with parallel slits on both sides, so that the band can be pulled away from the plane with the wall by applying force to open the slits. Advantageously, such movement of the locking segment may produce a non-circular form for the anchor. Such a locking segment may be kept open by sliding a retainer into the slit, such as the piston described above.

[0134] The shell segment can be formed by one or more tubular segments, which are made of any suitable material (i.e., medically appropriate material). Stainless steel or Nitinol can be used. Polymer materials are also an option. In an alternative, composite materials such as carbon fiber or glass fiber reinforced PEEK can be used. The catheter device can be formed by a combination of such materials, and the materials of the different parts of the device are selected according to the required properties of these parts. It is preferred to allow ultrasound to pass through and at the same time have sufficient strength. Carbon reinforced PEEK meets these requirements well and will also allow injection molding of components, which reduces manufacturing costs. Fiber reinforced plastics are generally invisible on X-rays, so non-transmissive markers placed strategically in all components can be used to determine the position and orientation of device components relative to each other on X-rays as supplementary information for ultrasound imaging.

[0135] As described above, the catheter device can be used to implant an anchor in the heart, and the anchor can be a papillary anchor for implantation in a papillary muscle, wherein the wire is, for example, an artificial cable. The catheter device can also be arranged to implant a leaflet anchor in the heart together with the papillary anchor as part of a procedure for implanting an artificial cable extending between the leaflet anchor and the papillary anchor. Thus, the catheter device can further include a leaflet anchor and a leaflet anchor deployment mechanism.

[0136] Thus, the shell segment can be a two-part shell segment, which is arranged to be placed between the papillary muscles and the leaflets of the heart during use of the catheter device, and the two-part shell segment includes a distal portion at the distal end of the catheter device and a proximal portion located on the proximal side of the distal portion; wherein the distal portion retains the papillary anchor deployment mechanism (i.e., the anchor and adjustment shell as described above), and the proximal portion retains the leaflet anchor deployment mechanism.

[0137] The leaflet anchor and / or leaflet anchor deployment mechanism may be similar to the leaflet anchor and / or leaflet anchor deployment mechanism of WO2016 / 042022.Alternatively or additionally, the leaflet anchor and leaflet anchor deployment mechanism may have features as described below.

[0138] An example of using the catheter device of the fourth aspect may include the following steps: (1) first placing the device close to the final placement position; (2) moving the distal portion toward the body tissue that will receive the anchor; (3) the distal end of the distal portion meets the body tissue, and when force is applied, the reaction force from the body tissue eventually exceeds the force holding the anchor in place, at which point the tissue is flattened under the base of the device, thereby giving the greatest chance of correctly placing all the hooks of the anchor in the tissue, and force can be applied to the anchor so that the ends of the hooks then move beyond the ends of the distal portion to meet the body tissue, which can be achieved by the rod or wire at the anchor. and / or additional force on the anchor deployment mechanism, or advantageously this can be accomplished by pre-tensioning the anchor which is maintained by friction with the distal portion until the force from the body tissue on the distal portion changes the balance of forces sufficiently under friction to cause the anchor to pop out (similar to a stapler); (4) the anchor hook deploys and forms into the hook shape of a non-constrained anchor, thereby engaging the body tissue, at which point the connection can be tested by an operator by pulling, and / or visually confirmed on X-ray and / or ultrasound; (5) if the connection is not satisfactory, the anchor can be pulled back into the device and repositioned to attempt to improve the connection between the anchor and the body tissue.

[0139] Viewed from a fifth aspect, the present invention provides a method of implanting an anchor into body tissue using the catheter device of the fourth aspect, the method comprising: deploying the anchor into the body tissue using an anchor deployment mechanism. Advantageously, the method may include: testing the connection of the anchor before the anchor is disengaged from the anchor deployment mechanism and the catheter device. In the event that the deployment of the anchor is unsatisfactory, the method may include: withdrawing the anchor from the body tissue and moving the anchor together with the anchor deployment mechanism back into the distal portion, wherein the non-circular shape of the distal portion engages with the corresponding non-circular form of the anchor and / or the anchor deployment mechanism so that once the anchor is returned to its stowed configuration within the distal portion, the anchor is in the correct orientation. The method may include using a device having any other features discussed below in conjunction with other device and method aspects of the present disclosure.

[0140] From a sixth aspect, the present invention provides a catheter device for implanting a leaflet anchor during a process of implanting an artificial cable into the heart, the catheter device comprising: a leaflet anchor for attachment to a leaflet of the heart; and a leaflet anchor deployment mechanism for deploying the leaflet anchor; wherein the leaflet anchor deployment mechanism allows the leaflet anchor to be retracted and repositioned via an ejector unit having a grasping device after the anchor is deployed into the leaflet, the grasping device having a first configuration and a second configuration, the first configuration being arranged to allow the leaflet anchor to be deployed into the leaflet without disengaging the leaflet anchor from the ejector unit, in the second configuration, the leaflet anchor is reversibly released from the ejector unit; wherein, in the first configuration, the grasping device of the ejector unit grasps the proximal end of the leaflet anchor, while the distal end of the leaflet anchor is not obstructed by the grasping device to enable it to be implanted in the leaflet; and wherein, in the second configuration, the grasping device of the ejector unit is disengaged from the leaflet anchor.

[0141] The leaflet anchor can be retracted along with the retraction tube / catheter by pulling on the cable so that the leaflet anchor is folded within the retraction tube. The retraction tube can be placed on top of the cable that is only attached to the leaflet (in the event that the device is removed) or a leaflet anchor that is placed in an awkward position (partially engaged, free floating, wrapped, etc.). The retraction tube can be a deflectable shaft with or without a flexible section on the tip (which allows the tip to find the base of the leaflet anchor to allow retraction). Alternatively, the retraction shaft can be a flexible tube that is arranged to engage with the base of the leaflet anchor. In either configuration, a marker band in the tip is required before applying tension to the cable to confirm that the retraction tube is at the base of the leaflet anchor to prevent any undesirable damage to the implant or native tissue.

[0142] Another alternative to retracting the leaflet anchor when it is free floating (not attached to anything) is to tighten the cable until the leaflet anchor can be folded within the papillary anchor housing either at the distal end or through an opening in the papillary anchor housing wall.

[0143] As will be seen from a review of WO2016 / 042022, in this previous proposal, once the gripper of the leaflet anchor deployment mechanism holds the leaflet, the leaflet anchor is pushed out, and after being pushed out, the leaflet anchor cannot be retrieved with the same mechanism. Although the leaflet anchor can be retrieved with the device of WO2016 / 042022, only one relatively complicated way is described to do this, and it involves a separate retrieval catheter. For the catheter device of the sixth aspect, in order to give the physician additional control, an "ejector unit" is introduced that allows the leaflet anchor deployment mechanism to deploy and also retrieve the leaflet anchor.

[0144] It will be appreciated that the features of the device of the sixth aspect may be combined with the features of the second aspect, thereby achieving the advantages of each aspect. Furthermore, there is a synergy in this combination, as the ability to remove and replace the leaflets is combined with the benefit of the ability to hold the catheter device in place at the leaflets while inserting the papillary anchors through the use of a flexible and optionally extendable joint. This allows the physician to check for maximum flexibility in the connection before inserting both anchors and requiring any significant movement of the device away from its position at the leaflet anchors. The device may also be moved from the leaflet anchor placement position to accommodate other means of papillary anchoring or its surroundings.

[0145] The telescopic shaft holding the device may be fitted with 4 pull wires so that the distal end may be moved to locate the correct valve position for anchor placement.

[0146] The leaflet anchor may be formed of a flexible material, have a hook-like shape in an unfolded configuration, and be capable of elastically deforming into a folded configuration, for example when constrained by the leaflet anchor deployment mechanism. The material of the leaflet anchor may be nitinol. The shape of the leaflet anchor may include a hook that is straightened when the leaflet anchor is in a folded configuration. The hook-like shape of the unfolded configuration may be, for example, a grappling hook shape. The leaflet anchor may have a form similar to WO2016 / 042022, and / or may have the features described below. In an exemplary embodiment, the leaflet anchor and the leaflet anchor deployment mechanism may be arranged such that: when the leaflet anchor is pushed out of the leaflet anchor deployment mechanism, this may drive the hooks through the leaflet, while the hooks elastically return to the unfolded configuration, thereby fixing the leaflet anchor in the leaflet.

[0147] In an exemplary device, after placement of the leaflet anchor, the cable is located in a groove in the device, and tension on the cable (shortening the cable) can be used to release the cable from the groove in which it is located. Removing slack in the system can reduce the chance of the cable being entangled in the device (thus causing complications). An example of a device to reduce slack would be some kind of constant tension device, such as a constant force spring. The constant tension device can be disposed in the delivery handle of the device.

[0148] The ejector unit may be placed inside the leaflet anchor deployment mechanism, inside the leaflet anchor. With this arrangement, when the ejector unit and the leaflet anchor are inside the leaflet anchor deployment mechanism, the ejector unit holds the leaflet anchor, wherein the gripping device is in a first configuration. The leaflet anchor deployment mechanism may deploy the anchor to implant it in the leaflet. In exemplary embodiments, the gripping device may be arranged to remain in the first configuration during this deployment process, wherein the ejector unit is arranged to move to the second configuration only after the leaflet anchor is implanted. With the leaflet anchor implanted, the gripping device may be used to test the connection of the anchor to the leaflet by applying a force from the ejector unit to the leaflet anchor while the gripping device is in the first configuration. Another way to test the connection is to assess the leaflet motion compared to blood flow, wherein the leaflet is attached to the leaflet anchor and thereby held to the catheter device, i.e., before releasing the leaflet anchor. If the leaflet anchor is well engaged, the movement of the leaflet will be more restricted than if it is not well engaged. Subsequently, with the ejector unit moved into the second configuration, the capture device of the ejector unit is opened, at which time the physician can further test the connection of the anchor to the leaflet, for example by applying tension to the cable line. If the physician is not satisfied (for example, if there is too much movement of the anchor and / or insufficient resistance to apply force on the line), the leaflet anchor can be retracted and placed in another position. If the capture device is not changed from the first configuration during the test, the latter process can be performed by reversing the deployment of the ejector unit and leaflet anchor, for example by pulling those parts back into the leaflet anchor deployment mechanism. If the second configuration is used before determining that the connection of the anchor is insufficient, the anchor is retracted, first the ejector unit is moved back to the first configuration, so that the capture device reengages the leaflet anchor, and then the deployment of the ejector unit and leaflet anchor is reversed, for example by pulling those parts back into the leaflet anchor deployment mechanism.

[0149] Use of the device of the sixth aspect reduces the risk of a poorly connected leaflet anchor requiring the procedure to be aborted and restarted, and this reduced risk has significant benefits for the efficiency of the procedure as well as the health of the patient. In addition, the retractable feature may allow the physician to more easily load and reload the catheter device with the leaflet anchor. If multiple cables need to be placed during a single surgical procedure, a reloading operation may be necessary. The method steps during the assembly of the device will also be improved.

[0150] In some examples, prior to deployment, both the leaflet anchor and the ejector unit are housed within a leaflet anchor tube of a leaflet anchor deployment mechanism, with the ejector unit being located further inside the leaflet anchor deployment mechanism than the anchor. The leaflet anchor tube may have a shape that is complementary to the shape of the leaflet anchor, i.e., has a similar cross-sectional shape. In some examples, both the leaflet anchor and the tube have a circular cross-section, with the leaflet anchor in a deformed configuration and placed into the tube. As described above, the leaflet anchor may be deployed into a hook-like shape, in which case the leaflet anchor may include a hook extending from a tubular body section. The ejector unit may also have a shape that is complementary to the shape of the leaflet anchor, i.e., has a similar cross-sectional shape, and thus this may also be a circular cross-section.

[0151] The leaflet anchor tube has an opening that can be directed toward the leaflet. The opening may not be at the distal end of the catheter device as a whole. In fact, the opening of the leaflet anchor tube may advantageously be directed toward the proximal end of the catheter device so that the leaflet anchor can be easily inserted through the leaflet from the base of the leaflet, which is required for the effective implantation of an artificial cord of a papillary anchor extending from the leaflet anchor to the papillary muscle. The leaflet anchor tube may be within a clamp arrangement as disclosed in WO2016 / 042022 and / or may have the features described below. Thus, the leaflet anchor deployment mechanism may include a clamp for clamping the leaflet during deployment of the leaflet anchor. Advantages may be provided if the catheter device combines the ejector unit of this aspect proposed with a clamp different from that of WO2016 / 042022 as described below, i.e., wherein the leaflet anchor is deployed with the clamp at an angle relative to the body of the catheter device.

[0152] In an arrangement using a leaflet anchor tube, the leaflet anchor can be arranged to be deployed by advancing the leaflet anchor and ejector unit along the tube, the leaflet anchor having a pin at its distal end that forms a hook into a hook-like shape when the pin exits the opening of the leaflet anchor tube. This can be done while the leaflet is clamped in the clamp of the leaflet anchor deployment mechanism as described above. As described above, once the leaflet anchor is implanted, the connection can be tested with respect to position and retention strength. If necessary, the leaflet anchor can then be pulled back into the leaflet anchor tube to release it from the leaflet. If the connection of the anchor is acceptable, the ejector unit can be advanced further to release the leaflet anchor.

[0153] Thus, in some examples, the change from the first configuration to the second configuration can be actuated by movement of the ejector unit along the leaflet anchor tube, for example by allowing the capture device to open when it reaches a specific position in the tube. In one example, the ejector unit has a constrained configuration as the first configuration, and an unconstrained configuration as the second configuration. In the first configuration, the ejector unit holds the leaflet anchor with a capture device, which can, for example, include two or more capture hooks arranged to engage with the leaflet anchor at the end of the leaflet anchor. In one possible arrangement, the capture hook has an end that engages with a hole formed in the leaflet anchor, preferably relative to the proximal end of the leaflet anchor in the distal direction of the leaflet anchor tube. The capture device can engage and disengage with the leaflet anchor via radial movement relative to the leaflet anchor tube. Thus, the constrained first configuration can involve the wall of the leaflet anchor tube to prevent outward radial movement of the capture device (e.g., capture hook), thereby forcing the ejector unit to remain engaged with the leaflet anchor. In the unconstrained second configuration, the capture device releases the leaflet anchor, e.g., via movement of separate capture hooks. The transition from the first configuration to the second configuration may occur by moving the ejector unit to a point where the constraint from the wall of the leaflet anchor tube is removed, so that the capture device opens, e.g., by outward radial movement of the capture hooks. This may be caused by parts of the ejector unit moving out of the leaflet anchor tube, i.e., out of the opening at the distal end of the tube, or may be caused by parts of the ejector unit moving into alignment with the cutout in the wall of the leaflet anchor tube.

[0154] The movement of the leaflet anchor and the ejector unit within the leaflet anchor deployment mechanism (e.g., along the leaflet anchor tube described above) can be actuated by wires and / or rods. A wire can be provided for pulling the ejector unit so as to retract the ejector unit. After successful implantation of the leaflet anchor or as part of the retraction of the leaflet anchor, it may be necessary to retract the ejector unit to allow it to be reimplanted. As described above, since the leaflet anchor tube can be toward the proximal end of the catheter device, the retraction of the ejector unit requires a pulling force toward the distal end of the device, so the wire for retraction can bypass a pulley or the like. The rod can be used for the deployment of the leaflet anchor, i.e., for moving the ejector unit along the leaflet anchor tube toward the opening at the distal end of the tube together with the leaflet anchor. In order to allow the thrust to be directed toward the proximal end of the catheter device, the rod can be a U-shaped rod. This can be arranged as described in WO2016 / 042022. The rod used for deployment is also capable of applying a pulling force for retraction, so the rod can be used alone. Alternatively, the rod can be used for deployment, while the wire as described above is used for retraction. In another alternative, the ejector unit may be moved by providing two wires and pulleys for movement in two directions. The U-shaped rod may be made of heat set or bent wire. Having one or more bends to form the U-shape and the shape of the push leaflet anchor.

[0155] A groove for guiding the ejector unit may be provided in the wall of the leaflet anchor tube. The groove may ensure that the ejector unit maintains a single orientation relative to the tube as it moves up and down. Alternatively or additionally, the groove may set a maximum limit to the range of movement of the ejector unit and may thereby prevent the ejector unit from moving too far out of or into the leaflet anchor tube in any direction. The ejector unit may be provided with a guide pin for engaging with the groove. Advantageously, a narrowing in the groove may be provided to act as an indicator so that the operator knows when the ejector unit has reached a certain position. The size of the guide pin and the width of the narrowing may be set so that engagement of the pin with the narrowing in the groove will require an increased force before further movement can take place, thereby providing tactile feedback to the surgeon.

[0156] In one example, a force feedback mechanism, such as a narrowing portion, is provided to indicate that the leaflet anchor has moved to the deployed position, but the ejector unit is still in the first configuration so that the anchor is still retractable. In this case, once the ejector unit is further pushed (e.g., so that the guide pin exceeds the narrow section), the ejector unit can be moved to the second configuration so that the leaflet anchor will be released from the ejector unit. Therefore, in one example, once there is a movement beyond the actuation point of the force feedback mechanism, such as when the guide pin passes through the narrowing portion in the above example, the constrained portion of the ejector unit (e.g., the above-mentioned catch) can be released from their constraints. Alternatively or in addition, there may be a feedback mechanism in the operating handle of the catheter device, which can indicate the position of the ejector unit, for example, by changing the force or by a visual indicator. In an alternative to the guide pin and narrowing slot system, another form of force feedback mechanism can act on the guide pin, such as a "shear pin" suture that breaks at a given point with a given load.

[0157] The leaflet anchor deployment mechanism may include a wire pusher for directing the wire away from and away from the leaflet anchor deployment mechanism during leaflet anchor deployment. When the device is in use, there may be a wire attached to the leaflet anchor. The wire may be arranged to form the artificial cable after implantation of the leaflet anchor, or to allow the artificial cable to be attached to the leaflet anchor. The wire may be a suture, such as a Goretex ePTFE suture. Advantageously, the wire pusher directs the wire away from the leaflet anchor deployment mechanism so that it can be more easily accessed for subsequent steering, such as for tightening the wire or for pulling the implanted leaflet anchor to test the connection. The wire pusher can be actuated during the deployment action of the leaflet anchor, and in some examples, the wire pusher is actuated when the leaflet anchor is released from the ejector unit. Thus, the wire pusher can be released when the ejector unit is withdrawn from the implanted leaflet anchor. The wire pusher can be transitioned from a constrained state to an unconstrained state in a manner similar to the above-described grabber, and thus the wire pusher can move radially outward to push the wire out, wherein the radial outward movement is allowed and the wire pusher is released once the constraint is removed. When the ejector unit is pulled back into the leaflet anchor deployment mechanism, the constraint can be from the leaflet anchor, and thus the constraint can be removed. In this case, the wire pusher can be an arm that extends axially forward from the ejector unit toward the leaflet anchor when at rest and without applying force, and extends radially outward from the leaflet anchor tube. Prior to the leaflet anchor deployment, the arm of the wire pusher is resiliently bent to place its distal end within the leaflet anchor so that it is constrained and cannot move to its radially outward position until the leaflet anchor and the ejector unit move apart. In some examples, as the ejector unit continues to be retracted into the leaflet anchor deployment mechanism, the wire pusher can remain in its unconstrained state, with the wire pusher and the wire being pushed out of a slit in the leaflet anchor deployment mechanism, such as a slit along the leaflet anchor tube.

[0158] The catheter device of the sixth aspect may also be provided with a papillary anchor and a papillary anchor deployment mechanism for deploying the papillary anchor to attach to the papillary muscle. The papillary anchor deployment mechanism may be arranged to deploy the papillary anchor by moving the papillary anchor outward in a distal direction relative to the distal portion. The papillary anchor deployment mechanism may be arranged in a two-part shell segment as discussed above with reference to the second aspect, in which case the leaflet deployment mechanism may be in the proximal portion of the two-part shell segment. Alternatively, the papillary anchor deployment mechanism may be similar to that described in WO2016 / 042022. In some examples, actuation of the leaflet anchor may be connected to the papillary anchor deployment, meaning that the leaflet and the papillary anchor may be arranged to be at least partially deployed simultaneously, for example by actuation of a single control line or rod. This may make the procedure easier and / or faster.

[0159] The nipple anchor deployment mechanism may include a lock that prevents the nipple anchor from prematurely ejecting, which may occur if the outer shaft (holding the device) is compressed while the inner nipple anchor deployment shaft is stretched or maintained at its original length while the outer shaft is shortened, thereby pushing the nipple anchor out of its housing. The lock may be an ejection tab that holds the anchor adjustment and ejector mechanism in place, which tab may be operated with torque, push or pull of a wire or suture. The actuation wire / suture may be guided through the holder housing and supported there or in the nipple housing, alternatively anchored in the anchor deployment mechanism itself. In a second configuration, the locking mechanism may be located within the nipple anchor deployment mechanism and actuated by a wire running within the adjustment catheter. As described above, wires and / or rods may be used to deploy and / or retract the ejector unit. In another variation, the ejector unit may be moved via a sliding sheath that engages with a lug on the ejector unit. The sheath may fit around the leaflet anchor tube. The sheath may be a partial tube, such as a three quarter tube, that extends around the leaflet anchor conduit. This arrangement may also be referred to as a "sled" or a "linear motion bearing". The sheath will push against a lug of the ejector unit as it moves. The sheath may be actuated by one or more wires or rods that may be connected to the sheath by a swivel joint. For example, there may be one or more wires that can be pulled or pushed by an operator. Nitinol wire may be used. When pulled or pushed, the sheath translates along the outside of the leaflet anchor tube, such as toward the opening of the tube and pushes the ejector unit via the lug. The lug may be a guide pin in a groove as discussed above.

[0160] The ejector unit and / or the leaflet anchor can be produced from a resilient metal (e.g., nitinol). The ejector unit and / or the leaflet anchor can be a laser-cut, heat-set, and electropolished metal tube. The guide pin and / or lug (if present) can be welded in place after assembly, for example, by laser welding. The catch of the ejector unit can be heat-set or laser-welded in place, and they can have any suitable shape for engaging with the leaflet anchor. The leaflet anchor tube can be attached to the leaflet anchor deployment mechanism, for example, to the clamp, by welding, brazing, or gluing, or it can be cut from a solid piece by subtractive manufacturing. Additive manufacturing techniques can also be used. Additional tubes can also be set next to the leaflet anchor tube, for example, for providing fluid flow or for covering wires. There can be a clamp tip at the end of the leaflet anchor tube, which extends laterally around the leaflet anchor tube to form a clamping platform that cooperates with the relative clamp element of the leaflet anchor deployment mechanism. The clamping platform can be formed by filling one end of the clamp with resin. The leaflet anchor tube can have an attached lever arm, such as a heat-set (or flattened) flat section or a curved section, wherein the lever arm is stretched through the axis of rotation of the clamp (which can move during movement of the clamp arm) to attach a wire for opening and / or closing the clamp.

[0161] The leaflet anchor tube may be laser welded to the holder tube segment within the cable slit.Additional features of possible holder arrangements may be similar to those disclosed in WO2016 / 042022 and / or may be set forth as follows.

[0162] From a seventh aspect, the present invention provides an anchor for implantation in body tissue to hold a thread, the anchor comprising a plurality of hooks for engaging with body tissue and having a folded position and an unfolded position, wherein the anchor is made of an elastic material so that: it can be elastically deformed to the folded position by applying a restraining force, and will return to the unfolded position when no restraining force is applied, and wherein the hooks are formed with openings along their length.

[0163] It should be understood that the anchor of this aspect can be used as a leaflet anchor or a papillary anchor. By adding openings in the anchor hook, a larger width hook can be used, thereby increasing the holding strength, while still allowing significant deformation between the folded configuration and the unfolded configuration without any plastic deformation. The increased surface area of ​​the larger width hook also helps distribute the deployment force. The openings can also enhance healing by allowing tissue to grow between the slits, forming a more reliable connection between the anchor and the tissue over time, rather than the tissue forming a "protective sleeve" that can be pulled out more easily, as is the case with solid hooks.

[0164] It will be appreciated that the anchor of this aspect, as well as providing its own advantages, may also be synergistically combined with the catheter device of the above aspect. Thus, an anchor having a hook with an opening may be used for the leaflet anchor and / or the papillary anchor of the above aspect.

[0165] Advantages arise if the anchor can releasably hold a line (e.g. a cable line), and therefore the anchor may further include a locking mechanism for clamping the line when no force is applied and being resiliently deformable to release the line from the locking mechanism to adjust the length of the line. This may use a locking ring as described below.

[0166] In some examples, the opening in the hook includes a plurality of holes (e.g., a plurality of holes having a diameter of approximately 0.2-0.4 mm) that are connected to sutures, wherein a single length of suture passes through all of several or more of the plurality of holes. The sutures may be knotted at each hole. The sutures may be, for example, Dyneema sutures (or other similar sutures, such as Dacron). Elastic materials such as Nitinol may be susceptible to fatigue fracture during high cyclic loads (including cyclic loads that would be generated by a beating heart). By using sutures that pass through a plurality of holes, the failsafe of the anchor pin may be increased. If the hook of the anchor breaks, the anchor is still held together by the sutures, which reduces the risk of embolism while also providing additional time for tissue ingrowth. Therefore, even if the anchor breaks early, it will not embolize, and it will still be able to maintain some force because even if one or more hooks break, the expanded anchor will be too large to be pulled through its entry hole. Using sutures in this manner will also create more "openings" for tissue growth to pass through. The plurality of holes may be circular holes made in addition to other openings in the hooks, such as circular holes made in addition to the slits as discussed below.

[0167] As an alternative to using sutures passed through the opening, the anchor may include an overmold that may be placed around the entire anchor, but it is possible that the sharp tip of the hook is not included. A suitable material for such an overmold is ePTFE. Another alternative is to use a woven fabric bag that surrounds the anchor. Both of these solutions will prevent the anchor from embolizing if there is a break in the anchor. Using ePTFE also provides the added benefit of tissue ingrowth.

[0168] The anchor can be formed from a tube that is cut to provide tines extending from one end of the tube, which are then bent and heat set to form the hooks. The openings can be cut into the tines before or after the tines are bent, but typically before the tines are bent so that there is only one cutting stage. An additional benefit of using an opening associated with this construction is that a small diameter pipe becomes more flexible with an opening in the center because the arc of the tube is divided into two smaller arcs. As a result, a wider portion of a narrow tube can be safely used to make the tines, which again provide additional strength. As a result of the increased retention and increased flexibility, the anchor hooks are subject to less fatigue loads, which in turn allows the implant to last longer.

[0169] These openings can be formed as a series of holes, or as slits that extend along the length of the tines and thus along the curve of the hook. The advantage of using slits is that each hook consists of two "legs", which means that a break in one "leg" does not mean that it will embolize, and the anchor is still held in place by the other leg. At the same time, the new "V" shaped legs will grow into the tissue more effectively than a straight "broken" hook without any slits or other openings, further reducing the risk of embolism.

[0170] These openings may include multiple smaller slits in rows or with different types of patterns (e.g., zigzag, barbed, or wavy patterns). Along the length of the hook, small holes with different patterns may be formed, either instead of or in addition to the slits. This may provide additional retention as tissue grows through the holes. It may also allow sutures to be passed through the hooks for added security in the event of a break as described above. The slits may also extend beyond the ends of the hooks, where they engage into the base of the anchor, which may be a tubular portion as discussed above, thereby making the base more flexible as well. In some examples, the slits may be cut as a single laser track. Circular openings may be added at the ends of such cuts to prevent high strain points.

[0171] In one example, the anchor is cut from a tube made of a resilient metal such as Nitinol. Laser cutting can be used. This can involve cutting tines as described above, which can be heat set into a curve. The anchor can be heat treated and / or electropolished. Before the anchor is electropolished, chamfered edges can be introduced into certain portions of the anchor. The openings can include barbed or wavy profiles along the edges of the openings (e.g., along the edges of the slits). When slits are used, the slotted hooks can be heat set into a configuration in which they have an increased distance when deployed. Then, when the pin is straight (when the barbs face each other), the barb profile can be hidden. In this example, when the anchor becomes a non-constrained configuration, the slits move apart and the barb profile is engaged.

[0172] In various aspects, the present invention extends to the use of the above-described catheter devices and anchors, particularly the use of these devices in the process of implanting an artificial cable into the heart. In addition, the present invention extends to the manufacture of the above-described catheter devices and anchors, including the various method steps described above, such as laser cutting from a tube. For any anchor or other laser cut part discussed herein, a beveled edge can be introduced before electropolishing the laser cut part (e.g., anchor).

[0173] Viewed from an eighth aspect, the present invention provides a method of using the catheter device of the second aspect for implanting both a leaflet anchor and a papillary anchor in a heart during a procedure for implanting an artificial cord extending between the leaflet anchor and the papillary anchor, wherein the method comprises: deploying the leaflet anchor into the leaflet using a leaflet anchor deployment mechanism; tilting the flexible joint so as to bring the papillary anchor deployment mechanism into close proximity with the papillary muscle (optionally, alternatively or additionally, extending the joint if the joint is extendable); and deploying the papillary anchor into the papillary muscle using the papillary anchor deployment mechanism. The method may include using a device having any of the other features discussed above with reference to any of the various device aspects and / or the method features discussed below. The method may include testing the connection of the leaflet anchor prior to deploying the papillary anchor, for example by testing as described above.

[0174] From a ninth aspect, the present invention provides a method of using the catheter device of the sixth aspect for implanting a leaflet anchor in a heart during a procedure for implanting an artificial cable, the method comprising: deploying the leaflet anchor into the leaflet using a leaflet anchor deployment mechanism, wherein the ejector unit is initially maintained in its first configuration; and later moving the ejector unit to a second configuration, thereby releasing the leaflet anchor. Advantageously, the method may include: testing the connection of the leaflet anchor before moving the ejector unit from the first configuration to the second configuration, for example by testing as described above. The method may include: if the connection of the leaflet anchor is found to be insufficient, maintaining the ejector unit in the first configuration, retracting the leaflet anchor into the leaflet anchor deployment mechanism using the ejector unit, and then re-deploying the leaflet anchor using the leaflet anchor deployment mechanism before testing the connection again. This may be repeated until sufficient connection is obtained, at which point the ejector unit should be moved from the second configuration to release the leaflet anchor. The method may include using a device having any of the other features discussed above with reference to any of the various device aspects, and / or method features as discussed above with respect to the second or eighth aspects or other aspects below.

[0175] From a tenth aspect, the present invention provides a method of using the catheter device of the first aspect to repair a heart by implanting an artificial cable, the method comprising: moving the second gripper arm away from the body of the catheter device; moving the first gripper arm away from the body of the catheter device; at least one of the following: rotating the first gripper arm to contact the second gripper arm to grasp the leaflet at a point spaced apart from the body of the catheter device; rotating the first gripper arm to contact the second gripper arm to constrain the leaflet before rotating the gripper arm to grasp the leaflet between the first gripper arm and the body of the catheter device; and pushing the leaflet anchor out of the leaflet anchor tube to pierce the leaflet and form the leaflet anchor into an unfolded configuration so that the hook-like configuration of the leaflet anchor secures the leaflet anchor in the leaflet. The method may include using a device having any of the other features discussed above with reference to any of the various device aspects, and / or method features as discussed in the method aspects herein.

[0176] From the eleventh aspect, the present invention provides a method for fixing an artificial cable to the heart using the anchor of the seventh aspect, the method comprising implanting the anchor into the tissue of the heart using an anchor deployment device. The anchor can be used as a papillary anchor, and the method therefore includes using a papillary anchor deployment mechanism. Alternatively, the anchor can be used as a leaflet anchor, and the method therefore includes using a leaflet anchor deployment mechanism. The method may include using a device having any of the other features discussed above with reference to any of the various device aspects, and / or method features as discussed in the method aspects of this article. The method may include testing the connection of the anchor to the heart tissue, for example by testing as described above.

[0177] From a twelfth aspect, the present invention provides a method of manufacturing the catheter device of the second aspect, the method comprising forming a flexible and optionally extendable joint by cutting of an elastic metal tube. Optionally, the same elastic metal tube is also used to form the distal and proximal portions of the two-part body section, so that the two-part body section is formed integrally with the flexible joint. Nitinol tubes can be used, and / or the cutting step can use laser cutting. The laser cut tube can be electropolished after cutting to remove any sharp edges.

[0178] Being able to form the device of the second aspect using the method of the twelfth aspect is believed to provide particular benefits, although it should be noted that other manufacturing methods as described above may be used. The method of the twelfth aspect may comprise providing the catheter device with any of the features discussed above with reference to the various device aspects.

[0179] From a thirteenth aspect, the present invention provides a method for manufacturing an ejector unit for a catheter device of the sixth aspect, the method comprising: forming the tines into a resilient metal tube by cutting; and deforming the ends of the tines by heat setting to form a hook-shaped configuration. The ejector unit may be provided with the features discussed above in conjunction with the optional features of the sixth aspect. The manufacturing method may comprise providing a catheter device as in the sixth aspect and inserting the ejector unit into the catheter device together with a leaflet anchor. Nitinol tubes may be used, and / or the cutting step may use laser cutting. The laser cut tube may be electropolished after cutting to remove any sharp edges.

[0180] From the fourteenth aspect, the present invention provides a method for manufacturing the catheter device of the first aspect, the method comprising forming the hinge of the first clamp arm integrally with the body of the catheter device by cutting an elastic metal tube. Optionally, the method may include forming the first clamp arm (including the hinge) integrally with the body. Being able to form the device of the first aspect in this way is considered to provide particular benefits, although it should be noted that other manufacturing methods as described above can be used. Nitinol tubes can be used, and / or the cutting step can use laser cutting. The laser cut tube can be electropolished after cutting to remove any sharp edges. The method of the twelfth aspect may include the catheter device being provided with any of the features discussed above with reference to various device aspects. The method can be combined with the method of the twelfth aspect to form a single integral body section, wherein the hinge of the first clamp arm (and optionally the remainder of the first clamp arm) is formed in the same integral section as the two-part shell section, and the distal part and the proximal part are connected by a flexible joint.

[0181] Viewed from a fifteenth aspect, the present invention provides a method of manufacturing the anchor of the seventh aspect, the method comprising: forming the tines as a resilient metal tube by cutting; forming an opening in the tines; and deforming the tines into a hook shape and heat setting them to form a hook with an opening. The anchor may be provided with the features discussed above in connection with the optional features of the seventh aspect. Being able to form the anchor of the seventh aspect in this way is believed to be of particular benefit, although it should be noted that other methods of manufacture as described above may be used. Nitinol tubes may be used, and / or the cutting step may use laser cutting. The laser cut tube may be electropolished after cutting to remove any sharp edges.

[0182] In any of the aspects discussed above, the leaflet anchor can be formed of an elastic material and arranged so that: it assumes an unfolded configuration when no force is applied, and can be elastically deformed to the folded configuration, for example when it is constrained within the leaflet anchor tube. The leaflet anchor can be made of a shape memory material, such as a shape memory metal. Nitinol can be used for the leaflet anchor. In some exemplary embodiments, the leaflet anchor is made of a laser cut Nitinol tube. The anchor can be subjected to electropolishing after laser cutting to remove undesirable rough or sharp edges. These edges can be beveled before electropolishing to introduce greater curvature, such as when sutures or wires can be placed against these edges when the anchor is used.

[0183] An exemplary form of a leaflet anchor for any of the above aspects is a grappling hook shape when it is in an unfolded configuration. Thus, the leaflet anchor may include a straight central axis having a plurality of hooks radially spaced about the axis. When in a folded configuration, the hooks will be straightened. The leaflet anchor may be conveniently manufactured by cutting a tube to form tines at one end, then bending the tines into hooks, with the other end of the tube forming a shaft. The shaft may have a relatively small diameter compared to the radial extent of the hooks in the unfolded configuration. For example, the shaft may have a diameter that is 30% or less (e.g., 20% or less) of the maximum radial extent of the hooks. In one example, the diameter of the shaft is 1-2 mm, and the hooks extend over a diameter of about 5-25 mm. If a shape memory material such as Nitinol is used, the tines may be bent and heat set into a grappling hook shape after laser cutting the Nitinol tube.

[0184] The leaflet anchor may be provided with one or more sheaths of a biocompatible material, such as a sheath of ePTFE, around the hooks. The material may be placed around most of the hooks, leaving the ends of the hooks free so as not to interfere with piercing body tissue. A single sheath may be used to provide coverage for both hooks through an incision that allows the sheath to extend through the center of the anchor and be threaded onto the two hooks on either side of the anchor. Such a sheath may be a tube having one or more openings along one side of the tube, wherein the sheath bridges the center of the anchor, thereby allowing the two hooks to be threaded into the openings at either side of the center. A method of making such a sheathed hook may include inserting the hook of the anchor into one or more sheaths, such as by threading the hook into one or more ePTFE tubes. An additional advantage of this method is that a synthetic cord may be threaded around the sheath, locking it in place in the center of the anchor. This would not be possible if the hooks were threaded with separate tubes and / or sheaths, and this allows for easier conventional manipulation of the wire.

[0185] From a sixteenth aspect, the present invention provides an anchor for implantation in body tissue to hold a line, the anchor comprising: an elastic material formed to have an unfolded configuration for placement within the body tissue and a folded configuration for use prior to deployment of the anchor, and arranged to allow the anchor to be placed into an anchor tube prior to deployment; wherein the anchor is arranged to be elastically deformed into the folded configuration by application of a restraining force, and to return to the unfolded configuration when no restraining force is applied; wherein when the anchor is in the unfolded configuration, the anchor has an elongated configuration comprising two anchor pins extending in opposite directions to either side of a center of the anchor, and when the anchor is in the folded configuration, the two pins both extend in the same direction; and wherein the ends of the pins are arranged to penetrate the body tissue.

[0186] It has been found that in some cases, some types of body tissue (e.g., the leaflets of the heart) do not heal as effectively as other types of body tissue (e.g., the heart wall). Therefore, in some cases, it is beneficial to provide an anchor designed to cause minimal damage to the body. Such a non-invasive anchor can provide advantages, particularly if the form of the anchor allows body tissue to grow easily around it. The slender form of the proposed anchor can allow minimal damage to thin body tissue such as the leaflets, while also allowing close contact with the tissue after implantation so that the tissue can grow around the anchor. The close contact and growth of tissue around the anchor means that the anchor prevents rotation and translation once it is implanted. When used as a leaflet anchor, the ends of the anchor pins can pierce the leaflets and pass through the leaflets during implantation, and when the anchor presents an unfolded configuration, the slender form will pass through the leaflets, with the outer portions of the two pins on one side of the leaflets, and the center of the anchor and the center portions of the two pins on the opposite side of the leaflets. This allows minimal trauma to the leaflets, with a relatively large surface area of ​​the pins placed against the surface of the leaflets after implantation. Additionally, the anchor can have a thin profile, which is more ideal for implantation into a thin body such as a leaflet.

[0187] It should be understood that the anchor of this aspect can be used as a leaflet anchor or for other forms of tissue, such as for a papillary anchor, although in the examples herein it is used as a leaflet anchor, as described below. The anchor can be included in an anchor deployment mechanism, which in turn can be part of a catheter device. In particular, the anchor can be disposed within a leaflet anchor deployment mechanism, such as in a catheter device for placing an artificial cable into the heart, including catheter devices of the type discussed above with reference to various device aspects. Thus, the anchor tube can be a leaflet anchor deployment tube of the above-described device.

[0188] The unfolded configuration is an elongated configuration comprising two anchor pins extending in opposite directions to either side of the center of the anchor, and the elongated form may be a generally straight shape. In the folded configuration, both pins extend in the same direction, and in some examples, the folded configuration has a U-shape. The ends of the pins are arranged to pierce the body tissue, and thus the ends may be sharp sections, having a pointed shape and / or sharp edges.

[0189] In one example, the anchor is formed by an elongated plate having a curve across its width. The elongated plate may, for example, have an aspect ratio of at least 5:1, for example an aspect ratio between 5:1 and 15:1. Typically, the length of the anchor (in the unfolded configuration) may be 5-10 mm. The curvature across the width serves to increase the stiffness of the anchor and thus increase the force with which the anchor pushes back toward the unfolded configuration. Once the anchor is folded, the curvature becomes flat, which means that further folding requires only relatively little force. When the anchor material is flat, the original curvature affects the amount of elastic strain in the anchoring material, which in turn affects the elastic force that forces the anchor to return to the unfolded configuration. For a plate thickness in the range of 0.05 to 0.5 mm, a typical radius of curvature may be in the range of 1-5 mm. In order to obtain a curved plate, the anchor may be formed by a deformed and heat-set flat plate. Alternatively, the curved plate may be provided as a section cut from a tube of the desired curvature. The latter method may involve fewer manufacturing steps because a pre-existing tubular section may be used to provide the required curvature.

[0190] In an alternative example, the anchor is formed of a tubular body having a weakened section at the center of its length to allow elastic bending of the tube. In this case, the end of the pin can be provided by a diagonal cut across the tube, leaving a sharp tip similar to the sharp tip on a hollow needle. The weakened section at the center of the length of the tube can be provided by cutting one or more openings in the tube. In this example, the length to diameter ratio of the tubular body can be at least 5:1, for example the length to width ratio is between 5:1 and 15:1. Typically, the length of the anchor (in the unfolded configuration) can be 5-10 mm. The tube wall thickness is 0.05-0.5 mm.

[0191] The anchor may be formed from a resilient metal, for example a shape memory metal such as Nitinol.

[0192] The anchor may include cutouts or edges shaped to alter bending properties, and / or to enhance tissue growth, and / or to prevent horizontal movement once placed. For example, slits, holes, barbs, depressions or ridges may be used. Features may be present to prevent lateral or rotational movement of the anchor after implantation. Thus, ridges or other features as listed above may be provided along the length of the anchor pin to inhibit lateral movement of the pin when in contact with body tissue. There may be an opening in the pin having the above features combined with the opening in the hook of the anchor of the sixth aspect. Such an opening may be formed as discussed above with respect to the method of making the anchor of the seventh aspect.

[0193] The anchor can have a coating or covering for promoting growth in body tissue and in particular for improving ingrowth in cardiac tissue. The coating or covering can cover the main part of the anchor but leave the ends of the pins exposed. An exemplary material for such a coating or covering is ePTFE. Another possibility is Dacron. Other biocompatible materials can be used. The anchor can be covered in a sheath of biocompatible material (e.g., an ePTFE sheath), which can be assembled by passing the anchor through a tube of material with the anchor in an unfolded configuration. Fabric or braided materials can be used. ePTFE has excellent ingrowth in cardiac tissue and has been well demonstrated in cardiac surgery. An anchor covered with ePTFE may grow into the leaflets, further increasing retention strength and additionally reducing the chance of embolism.

[0194] Where a sheath of material is used, sutures may be attached to the anchor, for example by threading sutures through holes in the sheath and anchor. This helps prevent the cover from being inverted or pulled into a "bundle", as well as reducing the chance of embolism if the anchor breaks, as the sheath and sutures hold the parts of the broken anchor together.

[0195] There is a synthetic cord attached to the anchor. The cord may be glued, knotted or threaded multiple times through the anchor to be attached, the cord may also be attached in two locations by a ring or the like to distribute the force and prevent horizontal movement if pulled at an angle. One or more injection molded parts may be used to reduce wear between the cord and the metal part of the anchor in the attachment point of the synthetic cord. The benefit of using two attachment points with injection molded protection around the cord entry point is that the cord entry point once placed prevents horizontal movement of the anchor.

[0196] As described above, the anchor may be included in an anchor deployment mechanism, which in turn may be part of a catheter device. In one example, this is a catheter device for implanting an anchor during a process of implanting an artificial cable into a heart, the catheter device comprising: an anchor, an anchor deployment mechanism for deploying the anchor, and an ejector unit for releasably grasping the anchor. The ejector unit may be releasably attached to the anchor at the center of the anchor. In some examples, the anchor deployment mechanism allows the anchor to be retracted and repositioned after being deployed into body tissue via the ejector unit, wherein the ejector unit has a grasping device having a first configuration and a second configuration, the first configuration being arranged to allow the anchor to be deployed into body tissue without the anchor being detached from the ejector unit, and in the second configuration, the anchor is reversibly released from the ejector unit; wherein in the first configuration, the grasping device of the ejector unit grasps the center of the anchor while the pin of the anchor is not blocked by the grasping device to enable the anchor to be implanted into the body tissue; and wherein, in the second configuration, the grasping device of the ejector unit is detached from the anchor.

[0197] It will be appreciated that the ejector unit of this example may take a form similar to that described above with respect to the fourth aspect. Thus, the structure and function of the ejector unit may be as discussed above, and the ejector unit and the deployment mechanism may interact as discussed above. The deployment mechanism may include an anchor tube like the leaflet anchor tube described above. The anchor may be a leaflet anchor.

[0198] The anchor may be provided with a tab or recess at its centre on either side of the width of the anchor to allow a gripping means of the ejector unit to better engage the anchor, for example by means of a corresponding hook or opening to engage the tab or hook to engage the recess.

[0199] From the seventeenth aspect, the present invention provides a method for manufacturing an anchor according to the sixteenth aspect, the method comprising: forming an anchor from an elastic material, wherein the anchor is in an unfolded configuration. The method may include forming the anchor as a curved plate or from a tubular body as described above. When the anchor is formed from a curved plate, the method may include cutting the curved plate from a tube of the same radius as the desired curve. It has been found that this provides a direct way to manufacture the curved profile required for the anchor. Alternatively, the anchor may be cut from a flat plate and then heat-set into a curved shape. The method may include providing a sheath of biocompatible material, such as a sheath of ePTFE, around the elastic material of the anchor. The method may include inserting the pin of the anchor into the sheath, such as threading the anchor into an ePTFE tube. This can be done by passing one end of the first pin through the sheath and pulling the elongated form of the anchor through the sheath. The sheath may surround the center of the anchor and most or all of the two pins, so that the ends of the pins are exposed. Alternatively, the sheath may surround most of the two pins, wherein the ends of the pins are exposed and have an opening at the center to allow the anchor to bend with less restriction from the sheath. The shape of the sheath is similar to that of the grapnel-shaped anchor described above.

[0200] Viewed from an eighteenth aspect, the present invention provides a method of securing an artificial cable to a heart using the anchor of the sixteenth aspect, the method comprising implanting the anchor into the tissue of the heart using an anchor deployment device. The anchor may be used as a papillary anchor, the method thus comprising using a papillary anchor deployment mechanism. Alternatively, the anchor may be used as a leaflet anchor, the method thus comprising using a leaflet anchor deployment mechanism. The method may include using a device having any of the other features discussed above with reference to any of the various device aspects, and / or method features discussed above in other method aspects. The method may include testing the connection of the anchor to the cardiac tissue, for example by testing as described above.

[0201] With respect to any of the aspects discussed above, it is advantageous that the leaflet anchor can be placed into the leaflet from below (i.e., from the side where the papillary muscles are located) so that the new artificial cable can pull the leaflet downward. However, the most convenient route into the heart involves a catheter that enters from above the leaflet. To facilitate placement of the leaflet anchor from below, the catheter device of any of the above aspects can be arranged so that the open end of the leaflet anchor tube is at the proximal end (the "upper" end, when in the heart in the orientation defined above) of the clamping device, and the leaflet anchor can be pushed out of the tube from the distal end of the catheter device toward the proximal end. The catheter device may include a U-shaped rod for deploying the leaflet anchor. This can be a U-shaped piece at the end of the wire used to actuate the leaflet anchor. Alternatively, it can be a U-shaped rod attached to a separate wire at one end of the U. In either arrangement, the free end of the U abuts the end of the leaflet anchor and is arranged to push the anchor toward the proximal end of the catheter device when the wire is pulled. The U-shaped rod should be sufficiently rigid to maintain its shape when pulled under the action of the force applied to the anchor. The ball may be placed at the free end of the U-shaped rod to allow it to best engage with the leaflet anchor (or with the ejector unit, if present). In this way, the leaflet may be pierced from below.

[0202] When the leaflet anchor tube is in a clamp arm (e.g., the first clamp arm), the U-shaped rod can extend into the clamp arm. In this case, the U-shaped rod needs to be sufficiently resilient to bend when the clamp arm is opened and closed. The U-shaped rod can have a flexible section, such as a section with a narrowed cross-section, to assist the bending movement. The U-shaped rod can also or alternatively be made of a suitable elastic material, which can be Nitinol. Advantageously, the elasticity of the U-shaped rod can act as a spring to return the clamp arm to the closed position.

[0203] Alternatively, the U-shaped rod wire can be made so that it does not need to bend when the clamp is opened, if the end of the U-shaped rod is small enough not to contact the wall of the leaflet anchor tube when the clamp is rotated, then it does not have to bend when the clamp is opened. This advantageously allows for a larger operating angle without being limited by the requirement to allow the U-shaped rod to deflect.

[0204] The catheter device of any of the above aspects may include a synthetic cable attached to the leaflet anchor. A hole or eyelet may be provided in the leaflet anchor for attaching the synthetic cable. In some exemplary embodiments, the cable is connected in the catheter device to a wire that enables it to be pulled or pushed. The use of such a wire allows the cable to be shortened and lengthened. The synthetic cable may be Suture or other suitable biocompatible material, such as thin nitinol wire, ultra-high molecular weight polyethylene (UHMWPE) wire, or a composite wire including a tough core (such as nitinol) or a high-strength suture and an outer coating (such as PTFE or ePTFE). The artificial cable may include an ePTFE suture tube that can be passed through a Dyneema core. The Dyneema core can be the same suture as the suture passed through the leaflet anchor described above. In addition, the ePTFE-Dyneema tube configuration of the artificial cable can be connected to the wire (preferably nitinol) at the opposite end of the leaflet anchor, for example, by passing the nitinol wire into the ePTFE tube together with the Dyneema core. The ePTFE tube and the Dyneema wire can then be attached to the nitinol wire by crimping, gluing or similar methods to allow the new artificial cable to be adjusted with minimal friction. This adjustment can be accomplished by adjusting the catheter. In some exemplary embodiments, the catheter device also retains a papillary anchor for attachment to the papillary muscle. The synthetic cable can extend from the leaflet anchor to the papillary anchor. In some embodiments, the synthetic cable connects the two anchors directly together without an intervening clip as in WO 2008 / 101113. This means that the synthetic cable can more closely mimic the natural cable and therefore be more effective in repairing the heart.

[0205] The adjustment catheter may have a stainless steel wire in its wall to allow it to apply a sufficiently strong pulling force to retract the nipple anchor. The adjustment catheter may further have one or more small cavities in the wall that allow actuation of the adjustment and cutting mechanism. A stainless steel flange may be attached to one or both ends of the shaft and this may be mechanically bonded to the shaft itself and the stainless steel wire in the wall of the shaft by, for example, welding, knotting, glue or material reflow, alternatively, the stainless steel wire in the shaft wall may form a loop around a feature in the stainless steel flange (which may be connected to an adjustment housing or may form part of an adjustment housing, such as a piston housing of an anchor holder of the type described above). The stainless steel flange may be laser welded to the nipple anchor cutting and adjustment mechanism.

[0206] According to any of the above aspects, the nipple anchor may be formed of an elastic material and may be arranged so that it assumes an unfolded position when no force is applied and can be elastically deformed to a folded position, for example when constrained within a nipple anchor housing of the catheter device. The device may be arranged so that the nipple anchor can be pushed out of the nipple anchor housing so as to pierce the papillary muscle with the hooks and securely engage the anchor with the muscle when the hooks are curled into the unfolded position. The nipple anchor may be made of a shape memory material, such as a shape memory metal. Nitinol is a preferred material for the nipple anchor. In a preferred embodiment, the nipple anchor is made of a laser cut Nitinol tube.

[0207] The papillary anchor may include a plurality of hooks for piercing and engaging tissue of the papillary muscle. Similar to the leaflet anchor, a grappling hook shape is possible, but a preferred design of the papillary anchor uses a tube segment that is slightly wider relative to the extent of the hooks. Thus, in some exemplary embodiments, the papillary anchor includes a tube segment with a plurality of hooks extending from one end of the tube, wherein the hooks extend over a diameter that is less than three times the diameter of the tube, such as approximately twice the diameter of the tube.

[0208] Similar to the leaflet anchor, the papillary anchor can be conveniently manufactured by cutting a tube to form tines at one end and then bending the tines into hooks, with the other end of the tube forming the body of the anchor. If a shape memory material such as Nitinol is used, the tines can be bent and heat set into a hook-like shape after laser cutting the Nitinol tube. The anchor can be electropolished after laser cutting to remove undesirable rough or sharp edges.

[0209] In any of the above aspects and optional features, when present, the papillary anchor may be provided with a mechanism for releasably clamping the synthetic cable. In one example, the papillary anchor is provided with a locking mechanism that clamps the cable when no force is applied and can be elastically deformed to release the cable for adjusting the length of the cable during implantation. This means that after the leaflet anchor and the papillary anchor are implanted, the new cable can be appropriately tightened while monitoring cardiac function to ensure that the repair is effective, and the cable can then be clamped by releasing the force on the anchor. After implantation, since the locking mechanism clamps the cable when no force is applied, the cable will be held between the leaflet and the papillary muscle at the correct tension. The papillary anchor can be laser cut prior to electropolishing. Introducing a bevel at the edge of the anchor can reduce the friction of the cable against its edge during adjustment of its length.

[0210] The locking mechanism may comprise an elastically deformable locking segment formed in the wall of the anchor and separated from the wall by one or more slits. The anchor may be arranged such that when no force is applied, the slits are closed with no gap or with a relatively narrow gap so as to clamp the wire, and when an appropriate force is applied to the locking segment and / or the wall, the locking segment and / or the wall will elastically deform to widen the opening provided by the slit so that the wire is released. The anchor may have a tubular body section, in which case the locking segment may be formed in the wall of the tube. The locking segment may be a band with parallel slits on both sides, such that the band may be pulled out of plane with the wall by applying a force so as to open the slits.

[0211] Such a locking section can be held open by sliding a retainer into the slit. The anchor can be used in a system comprising an anchor housing for holding the anchor in the unfolded position prior to implantation, a retainer for holding the locking mechanism open, a wire, and an anchor attached to the wire. The retainer can include a Z-shaped fork with prongs for insertion into the slit. Use of a Z-shaped fork can allow the path of the suture within the anchor housing to have a suitable curve.

[0212] It is considered important to use electropolishing to mitigate the risk of wear and / or cutting and to provide an anchor that can be securely clamped without cutting. For papillary anchors, the friction on the edge of the anchor experienced by the synthetic cord when its length is adjusted can be reduced due to the laser cutting beveling of the edge prior to electropolishing. Therefore, for a method comprising laser cutting a tube, and for an apparatus comprising a laser cut tube element, such as a laser cut anchor, electropolishing is advantageously used after laser cutting.

[0213] Certain exemplary embodiments of the present invention will now be described, by way of example only, and with reference to the accompanying drawings, in which:

[0214] Figure 1 A procedure for inserting a catheter device through the mitral valve is shown;

[0215] Figures 2 to 6 The action of a mechanical gripping mechanism using two gripper arms is shown;

[0216] Figure 7 shows grasping of a mitral valve leaflet by one of the grasper arms;

[0217] Figures 8 to 12 Deployment of a leaflet anchor in a device using an ejector device is shown;

[0218] Fig.13 shows a close up view of the valve during placement of the leaflet anchor, which is coupled to the synthetic cable;

[0219] Fig.14 The distal end of the catheter device is shown moved toward the papillary muscle for placement of the papillary anchor;

[0220] Fig.15 The withdrawal of the treatment catheter portion of the device and the adjustment of the cable length with an optional adjustment catheter are shown;

[0221] Fig.16 and Fig.17 An example of a hook for an anchor threaded with suture is shown;

[0222] Fig.18 and Fig.19 An example folded and unfolded configuration of a nipple anchor is shown;

[0223] Fig. 20 is a section through the lower (distal) portion of the body of the catheter device, showing how the body portion fits within the papillary anchor deployment mechanism;

[0224] Fig.21 Shown is the Fig. 20 Exemplary arrangements of the routing of synthetic cables and other cables within a papillary anchor deployment mechanism;

[0225] Fig. 22 Is has Fig. 20 The papillary anchor deployment mechanism and Figures 2 to 6 A cross section of an example of a clamping mechanism in FIG. 1 including one possible route of a synthetic cable between a nipple anchor and a first clamp arm.

[0226] Fig.23 is a cross-section of a leaflet anchor deployment mechanism using a leaflet anchor having a straight form when deployed;

[0227] Fig.24 Shows Fig.23 a leaflet anchor and ejector unit in which the leaflet anchor tube is omitted;

[0228] Fig.25 Shows the expanded Fig.23 of leaflet anchor;

[0229] Fig.26 A cover is shown around the anchor. Fig.23 of leaflet anchor;

[0230] Fig. 27 and Fig.28 An alternative form of straight anchor is shown in an unfolded configuration and a folded configuration;

[0231] Fig.29 Shown is a modified version of the Figures 4 to 6 The catheter device is similar to the catheter device;

[0232] Fig.30 Another example of an adjustment and cutting catheter is shown along with the papillary anchor;

[0233] Fig.31 is a side view of another example of a two-part housing segment for a catheter device;

[0234] Fig.32 Shown in different views Fig.32 Two-part shell section;

[0235] Fig.33 Another example of a catheter device is shown having a cross section through a housing section thereof;

[0236] Fig.34 Shows Fig.33 a distal portion of a housing segment of the device;

[0237] Fig.35 include Fig.33 perspective, side and cross-sectional views of the anchor and adjustment housing of the device, with housing sections omitted to show details of the anchor in the stowed position;

[0238] Fig.38 Shows something like Fig.37 A cross section in which the anchor is in an expanded, unfolded state;

[0239] Fig.39 and Fig.40 Shows Figures 35 to 38 Further details of the regulating housing;

[0240] Fig.41 and Fig.42 An inner cam of the adjustment housing is shown;

[0241] Fig.43 yes Fig.33 An exploded view of the various parts of the catheter device;

[0242] Fig.44 is a side elevation view of the anchor and adjustment housing, wherein the anchor is in an expanded, unfolded state;

[0243] Fig.45 A non-circular shape in the distal portion of the device including an engagement funnel is shown;

[0244] Fig.46 is a side view of the catheter device showing how the hinge pull wires are arranged;

[0245] Fig.47A and Fig.47B An exemplary self-locking knot that can be used to attach sutures and / or synthetic cords to a leaflet anchor is shown;

[0246] Fig.48A and Fig.48B Two different perspective views showing a piston wedge engaged with a locking segment, the piston wedge not in contact with the inner wall of the anchor;

[0247] Fig.49A The anchor is shown in a folded position with the tip extending outwardly, and Fig.49B An anchor with an inwardly extending tip is shown in a folded position;

[0248] Fig.50A Shown in unfolded position Fig.49A The anchor, Fig.50BShown in unfolded position Fig.49B Anchor;

[0249] Fig.51 A device handle capable of operating a catheter device is shown;

[0250] Fig.52A A dual-arm gripper is shown with the two gripper arms in an open configuration and Fig.52B The two gripper arms of the gripper device are shown closed together;

[0251] Fig.53A and Fig.54A A gripping device is shown passing through a model leaflet valve with a leaflet motion inhibitor above the leaflet and a first gripper arm gripping from below (not shown);

[0252] Fig.53B and 54B The clamping device is shown passed under the leaflet valve, with the leaflet motion inhibitor still above the leaflet, and the first clamper arm clamping from below (not shown);

[0253] Fig.53C and Fig.54C A gripping device for gripping a leaflet is shown, wherein a leaflet motion inhibitor grips the leaflet from above and a second arm grips the leaflet from below (not shown); and

[0254] Fig.55A , Fig.55B and Fig.55C An alternative arrangement for a leaflet motion inhibitor is shown.

[0255] The catheter device proposed herein is proposed for non-surgical (intravascular) insertion of a mitral valve cord to address mitral regurgitation caused by prolapse of the leaflets 12 of the valve. The figures show different forms of catheter devices 2 used for this purpose, but it should be understood that the general principles of each device are the same in terms of implanting leaflet anchors 10 and papillary anchors 9 in order to insert one or more artificial cords 14 into the heart. The artificial cords 14 are fixed to the prolapsed leaflets 12 and papillary muscles 26, thereby reconstructing normal anatomy. A single catheter device 2 is used to place the leaflet anchors 10 and papillary anchors 9. Using the same catheter device 2, the length of the cord 14 can be adjusted again to eliminate mitral regurgitation. Therefore, the new device is able to repair the mitral valve using a single minimally invasive intravascular procedure, providing significant advantages over earlier systems that required more invasive procedures and / or multiple operations.

[0256] It should be noted that while the endovascular approach is preferred and the device is therefore capable of using that approach, the device can certainly be used for different procedures, including more invasive procedures. Many of the advantages will be retained, and it is beneficial to use the device in situations where a more invasive procedure is required. In addition, it is contemplated that aspects of the design of the papillary anchor 9, as described above, can be used for anchors for other purposes, and the present disclosure is not intended to be limited in this regard.

[0257] The catheter device 2 described below can be used to insert the mitral valve cord through the venous system, starting from the femoral vein in the groin. The catheter is advanced to the right atrium. Reaching the left atrium is then achieved by a so-called transseptal puncture, after which a larger guide catheter is advanced into the left atrium. The catheter device 2 for cardiac repair is then introduced into the left atrium through the guide catheter.

[0258] The device is positioned using X-ray and ultrasound guidance, and as explained in more detail below, the mitral valve leaflets 12 are grasped and the new synthetic cord 14 is attached using the self-expanding leaflet anchors 10. The synthetic cord 14 is then attached to the papillary muscles 26 using the papillary anchors 9. Advantageously, Figures 2 to 6 , Fig.14 and Figure 20 to Figure 22 The catheter device shown in can be used to place the papillary anchor 9 while the leaflet 12 is still captured by the device. The cable length can now be adjusted to eliminate any mitral regurgitation. The excess cable is then cut and all catheters are withdrawn. The procedure is performed and the results monitored using echo and Doppler imaging. The successful use of this endovascular technology will greatly reduce the invasiveness, complications and costs of mitral valve repair.

[0259] The structure and function of the device are described in more detail below with reference to the accompanying drawings. The process of using one form of the device can be summarized as follows:

[0260] 1) The femoral vein was accessed using a standard transfemoral puncture (Seldinger technique) and a guiding catheter was introduced.

[0261] 2) The guide catheter is advanced into the right atrium under X-ray guidance.

[0262] 3) After crossing the atrial septum, enter the left atrium under X-ray and transesophageal echo guidance.

[0263] 4) Verify the correct location of the access site in the left atrium to ensure proper alignment of the guide catheter and treatment catheter insertion. The access hole in the atrial septum is dilated and the guide catheter is advanced into the left atrium.

[0264] 5) The treatment catheter device 2 is advanced through the guide catheter and positioned in the left atrium above the mitral valve.

[0265] 6) The prolapsed segment of the mitral valve leaflet 12 is located using ultrasound, and the treatment catheter device 2 is advanced into the left ventricle, and the gripper 6 of the treatment catheter device 2 is placed in position to grip the prolapsed segment. Advantageously, this can use a gripper 6 having two gripper arms 30, 32, as described below with reference to Figures 2 to 6 discussed in more detail.

[0266] 7) The prolapsed segment is clamped and after ensuring the correct position, the leaflet anchor 10 is pushed through the leaflet 12, allowing it to open and secure the leaflet 12.

[0267] 8) The connection of the leaflet anchor 10 can be tested while the leaflet anchor 10 remains attached to the catheter device 2 via the ejector unit 36, as described below with reference to Figures 8 to 12 As discussed further, and if the connection is adequate, the distal end of the catheter is advanced further into the left ventricle, advantageously using a Figures 2 to 6 and Fig.14 The flexible and extendable joint 34 shown in FIG. 1 or the flexible and extendable joint 34 shown in FIG. Fig.31 and Fig.32 The flexible joint shown in FIG. 8 is used to angle the joint without extending it until the distal end contacts the papillary muscle 26 or surrounding tissue.

[0268] 9) The papillary anchor 9 is pushed into the area of ​​the papillary muscle 26 and pushed out of its housing 8 , so that the papillary anchor 9 is opened inside the papillary muscle 26 .

[0269] 10) If the gripper 6 still grasps the leaflet 12, the leaflet 12 is then released, for example by releasing the leaflet anchor 12 from the ejector unit 36, as described below with reference to Figures 8 to 12 discussed.

[0270] 11) Adjust the length of the artificial cable 14 until the mitral valve regurgitation is eliminated.

[0271] 12) The catheter device 2 is pulled back from the papillary anchor 9 and the elimination of mitral regurgitation is reconfirmed by echocardiography.

[0272] 13) The position of the artificial cable 14 is locked at the nipple anchor 9.

[0273] 14) Cut the excess cable 14.

[0274] 15) Additional artificial cables may be placed if necessary.

[0275] 16) The catheter device is fully withdrawn and removed from the vascular system.

[0276] Figure 1A guide catheter 22 is shown which has been used to steer a catheter device 2 to a desired position within the heart, the catheter device 2 extending proximally through the mitral valve and thus between the two leaflets 12. The catheter device 2 consists of four different main parts: a steerable catheter, a holder housing 4, a holder device 6 and a nipple anchor housing 8 holding a nipple anchor 9. Advantageously, the holder housing 4 and the nipple anchor housing 8 may form a proximal portion 4 and a distal portion 8 of a two-part housing section having a central flexible and extendable joint 34, such as Figures 2 to 6 , Fig.14 as well as Figure 20 to Figure 22 Therefore, it should be understood that Figure 1 (and also in Figure 7 , Fig.13 and Fig.15 The procedure shown in FIG. 4 may use this arrangement for the holder housing (proximal portion) 4 and the papillary anchor housing (distal portion) 8. The steerable catheter may be replaced by an alternative arrangement using a steerable sheath surrounding the steerable catheter and a flexible tubing within the steerable catheter.

[0277] Figure 1 1 shows a front view of an exemplary catheter device, wherein the clamping device 6 is closed. Some arrangements of the clamping device 6 use a single clamp arm 30 that clamps the leaflet 12 against the clamp housing portion 4, such as Figure 7 In other arrangements, the clamping device 6 uses two clamping arms 30, 32, such as Figures 2 to 6 1, so as to allow the leaflet 12 to be grasped between the two gripper arms 30, 32 at a point spaced apart from the body of the catheter device. The gripper device 6 is part of a leaflet anchor deployment mechanism for deploying the leaflet anchor 10 to attach it to the heart leaflet 12. The gripper device 6 includes a leaflet anchor tube 38 for accommodating the leaflet anchor 10 in a folded configuration prior to deployment. In an exemplary embodiment, the leaflet anchor tube 38 is in the (first) gripper arm 30, e.g. Figure 2 and Figure 4 When the gripping device 6 grasps the leaflet 12 , the leaflet anchor 10 can be pushed out of the leaflet anchor tube 38 to pierce the leaflet 12 and form the leaflet anchor 10 into an unfolded configuration such that the hook-like configuration 40 of the leaflet anchor 10 secures it in the leaflet 12 .

[0278] The leaflet anchor 10 is connected to a synthetic cable 14, which may be located within a narrow channel extending along the surface of the first clamp arm 30 (e.g., as shown in FIG. Figures 8 to 12 ) and via the nipple anchor housing 8 to the nipple anchor 9 (e.g., as Figure 20 to Figure 22The passage may be slightly smaller than the diameter of the new synthetic cable 14 and / or have a thin shielding structure (not shown). This allows the synthetic cable 14 to be held in place due to a friction fit. The new synthetic cable 14 enters the nipple anchor housing 8 and passes through the nipple anchor locking section, through the locking and cutting member 18, and through the Z-shaped fork 20. Figure 20 to Figure 22 Describe these parts in more detail. A new synthetic cord 14 can be attached to the cord that goes all the way back to the outside along the catheter (to make the adjustment smoother). Because the cord can be pushed through the catheter, it allows the cord to be shortened by pulling or lengthening it during surgery.

[0279] The two-part housing section with the holder housing (proximal portion) 4 and the nipple anchor housing (distal portion) 8 may be approximately 6-7 mm in diameter and approximately 30 mm in length.

[0280] Figures 2 to 6 The steps of movement of the clamping mechanism 6 in an example with two clamping arms 30, 32 as described above are shown. The clamping mechanism 6 is part of a housing segment which also comprises a flexible and extendable joint which allows the papillary anchor housing 8 (distal portion) to be moved towards the papillary muscle 26 after the leaflet 12 has been grasped by the clamping mechanism 6. In this example, in order to grasp the leaflet 12, the first clamping arm 30 is rotated to move its end 42 away from the body of the catheter device, the rotation being achieved by a weakened area 44 of the tubular form of the body. It can be seen that the leaflet anchor tube 38 is located inside the first clamping arm 30, the end of which has an opening at the end 42 of the first clamping arm 30. With the first clamping arm 30 open, the second clamping arm 32 is free to rotate to move its end 46 out of the body. In this example, the second gripper arm 32 rotates about a hinge formed by a pin 48 which is placed in a hole in the proximal portion 4 of the two-part housing section, but it will be appreciated that a similar final placement of its end 46 may be achieved by a sliding movement. With the second gripper arm 32 folded outward, the first gripper arm 30 may be closed so that the two ends 42, 46 are in contact at a point spaced from the body of the device. This allows grasping of the leaflet 12. With the leaflet 12 in place, the leaflet anchor 10 may be moved out of the leaflet anchor tube 38 to be retracted, for example, by moving the leaflet anchor 10 as described below with respect to the Figures 8 to 12 The described mechanism with ejector unit 36 ​​implants the leaflet anchor 10, and the final positioning of the leaflet anchor 10 is similar to Fig.13 shown.

[0281] Figure 7 An alternative form of gripping mechanism 6 is shown which grasps the leaflet 12 with a single gripper arm which holds the leaflet against the gripper housing 4. This can also be used Figures 8 to 12 The ejector unit 36 ​​mechanism.

[0282] Ridged surfaces may be provided on the gripper arms 30, 32 to assist them in gripping the leaflet 12. 3D ultrasound and / or other available sources may be used to confirm that the gripper mechanism 6 has grasped the correct portion of the leaflet 12.

[0283] The gripping mechanism 6 can be opened and closed as many times as needed to grab the right portion of the leaflet 12. This opening and closing can be facilitated by a system that allows one wire to pull the gripping mechanism 6 open and one wire to pull the gripping mechanism 6 closed. As described above, different arrangements of wires and / or rods can be used to control the example with two gripper arms 30, 32. Once the position of the gripping mechanism 6 is determined, the leaflet anchor 10 can be pushed out of the end of the leaflet anchor tube 38, for example, by pulling the wire at the other end of the catheter. Fig.13 A close up view of the leaflet anchor 10 placed in the leaflet 12 is shown with the hook-like formation 40 engaged with the leaflet 12 .

[0284] As mentioned above, you can use Figures 8 to 12 The ejector unit 36 ​​is shown. Using the ejector unit 36, the leaflet anchor deployment mechanism allows the leaflet anchor 10 to be retracted and repositioned after the anchor 10 is deployed into the leaflet 12. This is achieved by the ejector unit 36, which includes: a grasping device 50, which has a Figure 8 and Fig. 9 The first configuration shown and Fig.10 and Fig.11 The second configuration is shown.

[0285] In the first configuration, the grasping device is arranged to allow the leaflet anchor 10 to be deployed into the leaflet 12 without disengaging the leaflet anchor 10 from the ejector unit 36. Thus, the grasping device 50 (which in this example comprises two grabbers 50 as shown) grips the leaflet anchor 10 and is able to move along the leaflet anchor tube 38 from the ejector unit 36 ​​to the ejector unit 36. Figure 8 The fully stowed position shown in FIG. Fig. 9 The anchor 10 is shown in the deployed position without releasing the anchor 10. When the grabber 50 is constrained within the leaflet anchor tube 38, the grabber 50 remains on the leaflet anchor 10. The ejector unit 36 ​​is thus arranged so that it remains in the first configuration while the leaflet anchor 10 is implanted. With the leaflet anchor 10 implanted, the grabber 50 and the ejector unit 36 ​​can be used to test the connection of the leaflet anchor 10 to the leaflet 12, for example by applying a force from the ejector unit to the leaflet anchor when the grabber 50 is in the first configuration.

[0286] When there is no longer any constraint from the leaflet anchor tube 38, for example when the grab hook 50 is Fig.10When the movement is shown beyond the end of the tube, the grasping device 50 moves to the second configuration. Thus, if the connection has been tested and the physician decides to release the leaflet anchor 10, they can further advance the ejector unit 36, which moves it to the second configuration. In this second configuration, the grasping device 50 of the ejector unit 36 ​​is disengaged from the leaflet anchor 10.

[0287] If the physician is not satisfied with the connection during testing (e.g., if the anchor 10 has too much movement and / or insufficient resistance to forces on the wire), the leaflet anchor 10 can be retracted and placed in another position. If the capture device 50 is not changed from the first configuration during this test, the latter process can be performed by reversing the deployment of the ejector unit 36 ​​and the leaflet anchor 10 (e.g., by pulling those parts back into the leaflet anchor deployment mechanism). If the second configuration is used before determining that the connection of the anchor is not suitable, the anchor 10 is retracted, the ejector unit 36 ​​should first be moved back to the first configuration so that the capture device 50 reengages the leaflet anchor 10, and then the deployment of the ejector unit 36 ​​and the leaflet anchor 12 is reversed, such as by pulling those parts back into the leaflet anchor tube 38.

[0288] A groove 52 is provided in the wall of the leaflet anchor tube 38 for guiding the ejector unit 36. The groove 52 ensures that the ejector unit 36 ​​maintains a single orientation relative to the tube 38 as it moves along the tube. The groove 52 can set a maximum limit to the range of movement of the ejector unit 36 ​​and thus prevent it from traveling too far in either direction out of or into the leaflet anchor tube 38. The ejector unit 36 ​​has a guide pin 56 for engaging with the groove 52. A narrowed portion 54 in the groove 52 is provided to serve as an indicator to let the operator know when the ejector unit 36 ​​has reached a particular position. The size of the guide pin 56 and the width of the narrowed portion 54 are set so that the engagement of the pin 56 with the narrowed portion 54 in the groove 52 will require an increased force before further movement can be made, thereby providing tactile feedback to the surgeon.

[0289] Figures 8 to 12 The leaflet anchor deployment mechanism of the present invention also includes a wire pusher 58, which is used to guide the synthetic cable wire 14 out of and away from the leaflet anchor tube 38 during deployment of the anchor 10. The wire pusher 58 guides the synthetic cable wire away from the leaflet anchor tube 38 so that it can be more easily accessed for subsequent steering, such as for tightening the wire 14 or for pulling the implanted leaflet anchor 10 to test the connection. The wire pusher 58 is actuated during the deployment action of the leaflet anchor 10, and the actuation is triggered when the leaflet anchor 10 is released from the ejector unit 36. Therefore, when the ejector unit 36 ​​is withdrawn from the implanted leaflet anchor 10, the wire pusher 50 is released.

[0290] In the example shown, the wire pusher 58 transitions from a constrained state to an unconstrained state and moves radially outward to push the wire 14 out, wherein the radial outward movement is permitted and the wire pusher is released once the constraint from the leaflet anchor 10 is removed. The wire pusher 58 is an arm that extends axially forward from the ejector unit toward the leaflet anchor 10 without the application of force and extends radially outward from the leaflet anchor tube 38 when it is at rest. Prior to deployment of the leaflet anchor 10, the arm of the wire pusher 58 is resiliently bent to place its distal end within the leaflet anchor 10, as shown in FIG. Figure 8 and Fig. 9 As shown, it is constrained and cannot move to its radially outward position until the leaflet anchor 10 and ejector unit 36 ​​move apart, as shown. Fig.11 Best shown. Fig.12 As shown, the wire pusher 58 remains in its unconstrained state as the ejector unit 36 ​​continues to be retracted into the leaflet anchor tube 38 , and the wire pusher 58 , as well as the wire 14 , are pushed out of the slit in the leaflet anchor tube 38 .

[0291] With the leaflet anchor 10 implanted in the leaflet 12, the papillary anchor housing 8 at the end of the treatment catheter is then placed onto the papillary muscle 26. By using a flexible and extendable joint 34, this can be done as Fig.14 . In this example, the flexible and extendable joint 34 is formed by a flexible curved section cut into the tubular form of the body. Advantageously, the flexible and extendable joint 36 is integrally formed with the tubular distal portion 8 providing the papillary anchor housing 8 and the tubular proximal portion 4 providing the holder housing 4. More advantageously, the tubular form of the holder housing 4 may include an integrally formed holder arm 30, wherein the weakened section 44 of the tube provides a hinge. The flexible and extendable joint 34 may be extended by means of a wire and / or rod 60 (or via an adjustment catheter 21, which may also push the papillary anchor 9 out), which wire and / or rod 60 may apply a force to stretch the elastic element of the joint 34. The extension is used to move the papillary anchor 9 within its housing portion 8 to place the papillary anchor 9 against or near the papillary muscle 26, because the wire / rod moves with the housing 8 together with the papillary anchor 8 within the distal housing portion 8 as the joint 34 is extended. This may be due to friction between the papillary anchor 9 (or papillary anchor push tube) and the inner surface of the distal portion 8 of the housing segment. The position may be determined by 3D ultrasound and / or other available sources.

[0292] When the distal end of the distal portion 8 encounters body tissue, and as further force is applied, the reaction force from the body tissue eventually exceeds the force holding the nipple anchor 9 in place, at which point the tissue is flattened below the base of the distal portion 8 giving the greatest chance of properly placing all of the pins 62 of the nipple anchor 9 in the tissue, and force can be applied to the nipple anchor 9 so that the ends of the pins 62 subsequently move beyond the distal end of the distal portion 8 to contact the body tissue. This can be accomplished by additional force from the rod or wire 60 acting on the nipple anchor or extending the adjustment catheter 21, or advantageously, this can be accomplished by pre-tensioning force applied to the nipple anchor 9 (or friction between the adjustment catheter 21 and the distal portion 8), which is maintained by friction with the distal portion until the force from the body tissue on the distal portion 8 changes the balance of forces with sufficient friction so that the nipple anchor 9 pops out in a manner similar to a stapler. When the nipple anchor 9 pops out, the pins 62 fold and form into the hook shape of the unconstrained nipple anchor 9, thereby engaging the body tissue 26. At this point, the connection can be pulled by the operator and / or visually confirmed on X-ray and / or ultrasound. If the connection is not satisfactory, the papillary anchor 9 can be pulled back into the distal portion 8 and repositioned to try to improve the connection of the anchor 9 to the body tissue 26.

[0293] Fig.15 Possible subsequent steps are shown. The main parts 4, 8 of the device are retracted to minimize the impact on the moving leaflet 12. The adjustment catheter 21 can be retained at the papillary anchor 9, and the adjustment catheter can include a Z-shaped fork 20 at its distal end, such as Figure 20 to Figure 22 As shown. The length of the artificial cable 14 can be adjusted with a wire from the outside. The length is continuously adjusted and the function of the leaflet 12 is monitored. The length of the artificial cable 14 can be reduced by pulling the cable back through the catheter. The length can also be increased by pushing the cable, which will relax the artificial cable 14 and allow movement of the leaflet 12 to pull it out of the adjustment catheter 21. The small size of the adjustment catheter 21 means that the impact of the device on the function of the leaflet 12 is minimized. The correct length of the artificial cable 14 is determined using 3D ultrasound and / or other available sources.

[0294] When the correct length is determined, the device is then disengaged from the nipple anchor 9. This procedure also locks the synthetic cord 14 in place and cuts off any excess which remains in the catheter and is withdrawn from the body when the catheter is removed. Figure 20 to Figure 22Further details including the Z-shaped fork 20 and the cutting piece 18 are described below. The Z-shaped fork is used to hold open the locking section 28 of the nipple anchor 9. The locking section 28 is a band of the nipple anchor 9 that can be bent to open a gap for the synthetic cable 14 to pass through. In the natural shape of the nipple anchor 9, when no force is applied, this locking section 28 fits tightly with the rest of the anchor 9, so it will hold the synthetic cable 14 in place. The Z-shaped fork 20 is used to hold the locking section 28 open until the synthetic cable 14 is the correct length. The cutting piece 18 cuts the synthetic cable 14 that is pulled against the blade when the adjustment process is completed.

[0295] Figures 16 to 19 More details of the nipple anchor 9 are included, including its hook 62 formed by bending the pin 62. Fig.16 and Fig.17 One possible form of hook 62 is shown having a central slit 64 and a series of holes 66 through which sutures 68 are passed. As described above, the sutures 68 and holes 66 can allow the hook 62 to better engage with body tissue during healing, as well as maintain the material of the hook 62 connected to the body of the nipple anchor 9 in the event of a break. Fig.16 The folded / constrained shape of the hook 62 is shown, which is also the shape of the tines formed in the tubular section during manufacture of the anchor 9 before being heat set to form the curve. Fig.17 The hook 62 is shown in a bent form, ie, an unfolded / unconstrained form.

[0296] Fig.18 and Fig.19 An example of a whole nipple anchor 9 is shown, again showing the folding ( Fig.18 ) and unfolded ( Fig.19 The nipple anchor 9 comprises a hook 62 having an opening in the form of a slit 64 which provides various advantages as described above, including better engagement with the body during healing and increased surface area without loss of flexibility.

[0297] The device may include a safety line 72 for preventing the nipple anchor 9 from being dislodged into the body if not properly placed. Once locking and cutting have been completed and the nipple anchor 9 is seen to be fixed to the papillary muscle 26 and the leaflet anchor 10, the safety line 72 is cut.

[0298] In order to deploy the leaflet anchor, a U-shaped rod can be used. The U-shaped rod 30 is housed within the clamp arm 30 and partially within the main part of the catheter, wherein the free end of the U is used to push the leaflet anchor 10 (and the ejector unit 36, when present) along the leaflet anchor tube 38. The U-shaped rod has a bendable section so that the clamp can be opened and closed when the U-shaped rod is inside. Advantageously, the bendable section can be used as a spring to apply a restoring force to return the clamp arm 30 to the closed position. The U-shaped rod is made of a material with a high degree of elastic deformation ability to allow bending of the bendable section. Suitable materials include shape memory materials, such as shape memory metals such as nitinol. Shape memory metals also have the advantage that the U-shaped rod can be made rigid, which makes it more efficient to transmit force with the U-shaped rod. The U-shaped rod can be composed of a thin nitinol wire and a tube on the outside of the wire to make the U-shaped section more rigid. Alternatively, the U-shaped rod can be made of several types of materials to achieve the desired properties.

[0299] As described above, when guiding the device and confirming the correct position of the leaflet 12 within the clamping device 6, imaging techniques such as 3-D ultrasound or fluoroscopy can be used. To help this, the echogenic properties of the device can be improved by sandblasting, mechanical texturing, or special coatings (e.g., echogenic polymer coatings). The clamping device 6 can also be provided with a detection system to confirm the position of the leaflet 12 within the clamp 6. In an improved clamp (not shown), a fluid-based sensor system is provided. This uses holes on the clamping surface of the clamp housing 4. These holes are connected to a fluid source, such as a contrast agent from a syringe, through a tube. When the clamp clamps the leaflet (or other tissue), the hole will be blocked by tissue that prevents fluid flow. This can be used to determine whether the leaflet is in the correct position to deploy the leaflet anchor. The device can be constructed with different numbers of holes, such as three or four, where a combination of open and closed holes is used to determine the position of the leaflet / tissue within the clamp 4. If four valves are placed in a square pattern, two closed valves and two open valves can indicate the correct position of the leaflet. In one example, the sensor system includes one to four fluid channels that can be located in the instrument wall, opposite the gripper arm, alternatively in the gripper arm tip. The channels connect to ports on the instrument handle where they can be injected with contrast media that can be visible on an echocardiogram or fluoroscopy. The lack (or reduction) of visible fluid and / or increased resistance to injecting fluid in both channels tells the operator that the leaflet is properly positioned before the leaflet anchor is deployed.

[0300] In another example, a pump with a monitoring circuit continuously pumps a small amount of water through the tubes of the sensor. The detection circuit can detect a pressure increase or change in the volume passing through each tube, which can indicate which tubes are blocked and to some extent how thick the tissue of the leaflet actually is (thinner tissue tends to cause smaller pressure increases relative to thicker tissue). The monitor device can, for example, be equipped with a simple LED that turns green if the leaflet is properly clamped. This will give the physician further confirmation (in addition to ultrasound) that they have captured the leaflet correctly, which ultimately leads to a higher success rate for the procedure. In a slightly different embodiment, the pump can be programmed to slowly pump fluid in and out of the tubes, which does not require additional fluid if the procedure takes a long time.

[0301] The device may include a suture / wire management system to prevent tangling. The suture may be held within the slit or tube until everything is ready to release the suture, which will reduce the chance of entanglement. The suture slit in the papillary housing 8 may be equipped with a one-way "suture valve" self-cut from the nitinol tube, which will prevent the native cord from entering the cord channel.

[0302] The synthetic cable 14 can be attached to the anchor in several ways. For example, with a cable through hole with a knot, welding or glue. The synthetic cable 14 can be made of Suture material or thin nitinol wire. The preferred embodiment uses Because it is easier to cut once the length is adjusted. The synthetic cord 14 has a diameter of about 0.1-0.6 mm. The leaflet anchor 10 has a diameter of about 1-2 mm and a length of about 4-6 mm (when straight).

[0303] The leaflet anchor pin can be cut into several different profiles to achieve different strengths and / or faster healing. Since the leaflet anchor 10 is cut from the tube using laser cutting, different shapes are easily produced. The anchor pin can, for example, have straight edges (minimum friction) or profiles for increased friction, such as smooth or sharp serrations, or barbed profiles. The shape of the anchor can vary depending on the needs of the procedure. Different anchor designs are available for the physician to choose based on their assessment of the patient.

[0304] As with the leaflet anchor pins, the papillary anchor pins can be cut into several different shapes to achieve different pull-out strengths and / or faster healing. The anchor pins can, for example, have straight edges (minimum friction) or profiles for increased friction, such as smooth or sharp serrations, or barbed profiles. The shape of the anchor can vary depending on the needs of the procedure. Different anchor designs are available for the physician to choose based on their assessment of the patient.

[0305] Figure 20 to Figure 22The interaction of the nipple anchor 9 with the cable and cutting element 18 of the catheter device is shown. The cutting element 18 is made of a suitable biocompatible material, preferably cut with a laser, and sharpened by grinding away some material. The material can be, for example, stainless steel, titanium or a titanium alloy. Nitinol can also be used. The Z-shaped fork 20 is used to hold the locking segment 28 open to provide space for the cable between the locking ring in the nipple anchor 9 and the locking segment 28.

[0306] As described above, once the nipple anchor 9 is placed and the delivery device is retracted, the cable length is adjusted using the cable wire 14. During the analysis of the length, an optional cable lock (not shown) can be pulled to gently clamp the synthetic cable wire 14 in a temporary adjustment state, which will otherwise hold the wire from the outside. Once the correct length is reached, the locking wire 70 is pulled, which bends / retracts the Nitinol Z-shape 20 and locks the cable in place by releasing the locking segment 28. The cutting member 18 is then pulled and its Nitinol blade engages the synthetic cable wire 14 and one strand of the nipple anchor retainer suture 72. The nipple anchor 9 is now free of the adjustment and cutting devices 18, 20.

[0307] The use of a Z-shaped Nitinol prong 20 to hold the locking segment 28 open allows a very gentle bend in the suture / cable path. It also allows the suture to exit the device in line with the holder opening. This is important to obtain the best possible loading conditions on the nipple anchor (the cable exits the anchor in the correct position for optimal holding strength).

[0308] In one embodiment, the cutter 18 is made of thin sheet Nitinol that allows the blade to be pulled around a curved surface to allow for a minimal footprint of a relatively long sliding action component (which can, for example, be pulled perpendicular to the cutting surface, taking up less space). The Z-shaped fork 20 can be made of a laser cut, heat-set Nitinol sheet part, where certain sections can be thinned to obtain different thicknesses and flex along the section. A simple temporary wire lock can be added that, when pulled, will gently squeeze the cable 14 to maintain its temporary adjustment length, and also hold the wire connected to the cable 14 on the outside (not shown). Note that the support inside the adjustment device 21 is not shown. If the anchor 9 needs to be retrieved, a bevel cut on the top of the adjustment "box" will allow the device to find the anchor 9.

[0309] In one embodiment, the push-out tube connected to the papillary anchor 9 contains several markings that can be used as rough reference points on the distance between the papillary anchor and the leaflet anchor, which can allow the physician to roughly adjust the cable before making the final adjustment, as they usually have an idea of ​​what the final cable length should be.

[0310] In order to prevent the cutter 18 from exceeding its desired range of motion, the cutter 18 can be equipped with two stop features arranged at the upper and lower ends of the cutter 18. In order to prevent the cutter 18 from moving further than its upper position in the housing, the cutter wire can pass through the housing and / or the cutter to stop the cutter 18 in the upper position. Even if the cutter wire breaks, since the cutter 18 and the wire attached to the cutter operating it are both contained in the housing, the cutter and the wire attached to the cutter operating it cannot be detached from the upper end of the housing. In order to prevent the cutter 18 from moving further than its lower position in the housing, a cam can be used.

[0311] The shaft of the portion of the catheter device 2 that accommodates the cutter 18 and the adjustment device 21 (not shown) can be constructed with two lumens: a cable lumen and a cutter lumen. The construction can be strengthened by braiding around the cable lumen (the shaft can also include any lumen required to accommodate the pull wire for operating the device, which can also be strengthened by braiding). In addition to braiding, a line made of Kevlar or other similar materials can be implemented in a structure extending along the length of the shaft to increase the tensile strength of the device 2. Additionally or alternatively, a composite tube can be positioned around the lumen. The components and conduits of the shaft can also be embedded in a soft polymer, such as Pebax (for example, by Pebax reflux), to allow sufficient winding. The composite conduit can also be anchored in the distal end to prevent the conduit from being torn out of the soft polymer during the actuation of the cutter line. The composite conduit can be anchored in the distal end with, for example, a flat ribbon coil, a stainless steel sea wave tube ring, or a stainless steel sleeve ring.

[0312] The braid surrounding the cable lumen may include a laser cut hypotube that increases the tensile and compressive strength of the shaft construction. The laser cut hypotube may be "bend-tailored" so that different sections have different flexibility patterns to accommodate the desired movement of the shaft. The laser cut hypotube may also be welded directly to the head of the cutter 18. The secure bond between the cutter head and the laser cut hypotube allows for more reliable retrieval of the papillary anchor if readjustment is required. A braided composite tubing may be disposed outside of the laser cut hypotube to form a line lumen.

[0313] In some cases, natural cords may be a problem with the device. There is a risk of contamination if one of the existing cords gets stuck in the hole provided for the exit of the new synthetic cord 14. One way to eliminate this is to have a one-way cord exit so that the synthetic cord 14 can only exit the device and not enter, although this feature is not necessary.

[0314] Inside the nipple housing 8 there may be a small notch in the wall to hold the pin of the nipple anchor 9 and prevent the nipple anchor 9 from rotating so that the pin can be folded outwards in the opening for the new cord 14 .

[0315] As mentioned above, one form of anchor is a grappling hook shape. Another possibility that has particular advantages for the leaflet anchor 10 is an anchor having an elongated shape, such as a slender straight body or an elongated tubular form. An example of such an anchor 10 is shown in Figure 23 to Figure 28 The elongated anchor 10 may be used in place of the above-described grappling hook-shaped anchor 10 and thus may be used, for example, in a catheter device and paired with a papillary anchor, such as Figures 1 to 22 shown.

[0316] Figure 23 to Figure 26 One advantageous form of elongate anchor 10 for use as a leaflet anchor 10 is shown. Figure 23 to Figure 26 The leaflet anchor 10 has an unfolded configuration for placement within body tissue, such as Fig.25 and Fig.26 As shown, and the folded configuration used before the anchor 10 is deployed, as Fig.23 and Fig.24 38. The unfolded configuration is U-shaped and allows the anchor 10 to be placed into the anchor tube 38 prior to deployment using a mechanism similar to the leaflet anchor deployment mechanism described above. Thus, the exemplary embodiment uses an ejector unit 36 ​​that grasps the leaflet anchor 10 via a grasping device 50, and the ejector mechanism 36 also includes a suture pusher (thread pusher) 58. The anchor 10 is attached to a synthetic cable 14, which in turn may be attached to a papillary anchor as described above. The function and structure of the leaflet anchor deployment mechanism are generally as described above, except that the anchor has a different form as shown.

[0317] The elongated leaflet anchor 10 can be elastically deformed to have a Fig.23 and Fig.24 The U-shaped folded configuration shown, Fig.23 A cross section including the leaflet anchor tube 38 is shown, and Fig.24 The leaflet anchor tube 38 is shown in a folded configuration with the leaflet anchor tube 38 omitted from the drawings. The elongated leaflet anchor 10 includes two pins 82 that form U-shaped arms in the folded configuration. At the end of each pin 82 there is a sharp pointed tip 84. The fold of the U is centered at the center 80 of the anchor, which is where the synthetic line 14 is attached. The ejector unit 36 ​​grabs the elongated leaflet anchor 10 on either side of the center 80 by hook-like arms 50 similar to those described above. The anchor elongated leaflet 10 is held in the U shape by applying a restraining force from the walls of the leaflet anchor tube 38, and will return to the unfolded configuration when no restraining force is applied, which occurs when the elongated leaflet anchor 10 has been pushed out of the end of the leaflet anchor tube 38. Fig.25 This configuration is shown in which the ejector unit 36 ​​has also been moved to its second configuration in order to release the elongated leaflet anchor 10. As described above, the ejector unit 36 ​​may have the form and function described above, for example in combination with Figures 8 to 12In the unfolded configuration, the elongated leaflet anchor 10 straightens into an elongated configuration in which two anchor pins 82 extend in opposite directions from each other, preferably parallel and opposite to each other, with one pin 82 on either side of the center 80 to which the wire 14 is attached.

[0318] Thus, when the elongated leaflet anchor is in its folded U-shape and it is advanced beyond the end of the leaflet anchor tube 38 via the leaflet anchor deployment mechanism, the end 84 of the anchor pin 82 will pierce and pass through the leaflet 12. As the center 80 of the elongated leaflet anchor 10 approaches and then passes over the end of the anchor tube 38, it will straighten into a Fig.25 Thus, when the elongated leaflet anchor 10 assumes the unfolded configuration, the elongated form will pass through the leaflet 12 with the outer portions of the two pins 82 on one side of the leaflet 12 and the center 80 of the elongated leaflet anchor 10 and the center portions of the two pins 82 on the opposite side of the leaflet 12.

[0319] Fig.26 A possible further advantageous feature is shown in which the elongated leaflet anchor 10 is surrounded by an ePTFE sheath 86. The purpose of the ePTFE sheath 86 is to promote tissue growth into and around the anchor during healing, as well as to protect the anchor 10 and allow it to remain as a single piece in the event of a break. The sheath 86 is attached to the body of the anchor 10 by sutures.

[0320] exist Fig.23 In an example of , the anchor is formed from an elongated plate having a curve across its width. The curvature across the width serves to increase the stiffness of the anchor and therefore the force with which the anchor is pushed back towards the unfolded configuration. Once the anchor is folded, the bottom curvature will become flat, meaning that further folding requires only relatively little force. When the anchor material is flat, the original curvature affects the amount of elastic strain in the anchoring material, which in turn affects the elastic force that forces the anchor to return to the unfolded configuration. For plate thicknesses in the range of 0.05 to 0.5 mm, typical radii of curvature may be in the range of 1-5 mm. In order to obtain a curved plate, the anchor may be formed from a flat plate that is deformed and heat set. Alternatively, the curved plate may be provided as a section cut from a tube of the desired curvature. The latter approach may involve fewer manufacturing steps because pre-existing tubular sections may be used to provide the required curvature.

[0321] In an alternative example, Fig. 27 and Fig.28 As shown, the elongated leaflet anchor 10 may be formed of a tubular body having a weakened section at its center 80 to allow for elastic bending of the tube. Figure 23 to Figure 26Like the elongated leaflet anchor 10, the elongated leaflet anchor 10 can be folded into a U-shape and unfolded into an elongated generally straight form, and it will be appreciated that it can be unfolded through the leaflet anchor tube 38 and ejector unit 36 ​​as described above. To provide the sharp tip 84 of the pin 82, a diagonal cut is then made through the tube so that the sharp tip 84 is similar to the sharp tip on a hollow needle. The weakened section at the center 80 of the tube can be provided by cutting one or more openings in the tube, such as in Fig. 27 and Fig.28 as shown in .

[0322] Fig.29 Another possible feature of the catheter device is shown. This is a sliding cable holder 88, which can be used to pass the synthetic cable 14 through the flexible and extendable joint 34 and down to the path of the nipple anchor 9 in the distal portion 8 of the housing. The sliding cable holder 88 is fixed in place relative to the proximal end of the device and therefore does not move relative to the proximal portion 4 when the flexible and extendable joint 34 is extended. It then slides relative to the distal portion 8 of the housing. The sliding cable holder 88 reduces the risk of the synthetic cable 14 being clamped in the flexible and extendable joint 34. As best seen in the lower enlarged section, the sliding cable holder 88 includes a channel 90 that holds the synthetic cable 14. In addition, as best seen in the upper right view, in which the housing is omitted, the sliding cable holder 88 has a profile formed with side rails that are used to guide the sliding movement.

[0323] In addition, the sliding cable holder 88 can reduce the risk of the line 14 being caught in any other flexible joints (e.g., the flexible hinged section in the proximal housing portion 4 that moves with the clamp arm 30). A suture push-out device can be provided to allow the user to selectively push the synthetic cable 14 out of the channel 90 of the sliding cable holder 88. In this case, a thin line can be placed under the synthetic cable 14 in the channel 90, and the thin suture is connected to a small sliding wedge so that when it is pulled, the wedge moves within the channel 90 to push the synthetic cable 14 out of the channel 90. This feature allows the user to select the point at which the synthetic cable 14 is released from the device, which further reduces the risk of entanglement.

[0324] A thin thread may also be used to separate an initially closed channel by breaking along a weak point or by spreading a tube around a slit. This may mean that the synthetic cord 14 is initially closed, but when the thread is pulled, the protective cover opens or is otherwise removed from the outer surface of the channel 90 and allows the synthetic cord 14 to escape from the channel 90 or be pushed out by a suture push-out device.

[0325] Fig.30An alternative way of arranging an adjustment and cutting catheter 21 having multiple features with a nipple anchor 9 is shown. The arrangement shown holds the wire clamping mechanism in an open position, secures the nipple anchor 9 to the adjustment catheter 21 and provides a way to cut excess wire 14.

[0326] The inner cam 91 can hold the nipple anchor locking segment 28 in an open position, i.e., the slit is open, and the cam 91 advantageously performs several tasks simultaneously. The cam 91 can open the slit of the locking segment 28 and secure the nipple anchor 9 to the adjustment catheter 21. In addition, the cutting portion 94 can be engaged to the cam wedge 95, which holds the cam 91 in an open position, allowing the excess synthetic cable 14 to be cut with the same movement. This reduces the need for a line passing through the adjustment catheter 21. The cam 91 is held in place and supported by a retainer that prevents the cam from twisting and / or bending when actuated. The adjustment housing 92 can have a protruding feature or interference fit around its perimeter that snaps into place with a support bracket in the distal portion of the device to allow the adjustment catheter 21 to extend the flexible and adjustable joint 34 and then push the nipple anchor 9 out once the tissue on the distal portion 8 of the catheter device applies an appropriate amount of counterpressure.

[0327] In this example, the nipple anchor 9 locking section 28 is held open by an internal cam 91. The cam 91 has a rest position ( Fig.30 Not shown, but note that in the following Fig.41 and Fig.42 A similar arrangement exists in ) and an open position, such as Fig.30 As shown, when the cam 91 is in its open position, the nipple anchor 9 and the locking segment 28 are held open by applying a restraining force internally. The cam 91 is held in place by a housing 92, which structurally supports the cam 91 during its travel. In addition, the adjustment housing 92 contains a wire channel 93 and a slide channel 99 for a combined cutting and cam wedge 96 / 95. When the cam wedge 95 engages with the wedge groove 98 of the cam, the anchor locking ring 28 is held open, and the synthetic line 14 can then pass relatively freely through the wire channel 93 and through the open locking ring 28. Once the wire 97 connected through the attachment hole 100 in the cutting wedge 96 is pulled, the wedge 95 disengages from the wedge groove 98 and the cam 91 returns to its rest position, clamping the wire 14 and releasing the nipple anchor 9 from the adjustment housing 92. During or immediately after the release of the cam 91, the cutter 94 engages with the wire 14. The cam 91 and the cutting wedge 96 can have a cylindrical shape to accommodate close tolerance machining. One or both of the cutting edges may also be equipped with flat or rounded blades.An additional two-legged fork structure (not shown) connected to a wedge 96 that holds the locking segment 28 open may also be included to ensure that the locking segment 28 of the anchor is fully open while the suture 14 is adjusted.

[0328] The adjustment housing 92 may have protruding features or interference fits (not shown) around its periphery that snap into place with features in the distal portion 8 of the device to allow the adjustment catheter 20 to extend the flexible and adjustable joint 34 and then push out the nipple anchor 9 once the tissue 26 on the distal portion 8 of the device applies the appropriate amount of counter pressure. It should be understood that Fig.30 The arrangement may be combined with any of the previous embodiments for holding the catheter device in place or other arrangements for retaining the nipple anchor 9 and for operating the locking ring 28.

[0329] The adjustment housing 92 may have a recess (not shown) for a locking tab (not shown) that holds the nipple anchor 9 in place to prevent it from popping out prematurely as previously described. The locking mechanism may be a tab connected to the torque line that locks into the nipple anchor 9. Suitable locking mechanisms may include those described below with reference to Figures 34 to 36 The latch of the device.

[0330] Fig.31 and Fig.32 A variant of the design of a two-part housing section of the catheter device 2 is shown. Fig.31 is a side view of the housing section with the angled flexible joint 34 ′ and the clamping device 6 opened. Fig.32 A two-part shell section is shown in a straight configuration in which the cable channel 90' can be seen. This design for the two-part shell section can be used in place of the flexible and extendable version described above, with the other features of the device remaining the same. It has been found that it is possible to reliably accomplish the implantation of two anchors in a single procedure using such a device, wherein the flexible joint 34' allows the distal end to be angled toward the papillary muscle 26 for implantation of the papillary anchor 9 without the use of an extension at the distal end. This variation also illustrates the possibility of using different materials, as the two-part shell section and the holder can be formed from a composite material such as fiber reinforced PEEK, which can also be a variation of other arrangements applied to the catheter device 2 described above. This type of composite material can give the device greater visibility via ultrasound imaging during image-guided surgery, wherein the visibility can optionally be further enhanced by the addition of reflection enhancing features, such as using a recess 102 as shown. The two parts of the two-part shell section are joined by a hinge element 104, which can be actuated via one or more wires (see Fig.46 ). The pull wire that actuates the device can advantageously be passed around the hinge element, which provides a low friction transition in the pulling direction. Other features of the device can be similar to those described above, such as the clamping mechanism 6 and the anchor deployment system.

[0331] Fig.33There is shown a cross-sectional view of another example of a catheter device 2. As can be seen, the holder arms 30 are engaged with the holder housing 4 in a closed position, ready for the leaflet anchor 10 to be deployed.

[0332] The leaflet anchor channel in the holder arm 30 can be manufactured with one or more anti-rotation grooves 122 in the form of one or more slits or grooves 122 extending along the interior of the leaflet anchor channel in the holder arm 30. When engaged with a suitable engagement mechanism (not shown), the grooves 122 help prevent rotation of the leaflet anchor 10 during its deployment. In this example, at least one tip of the hook of the leaflet anchor 10 slides within the groove 122, preventing the leaflet anchor 10 from rotating. A non-circular oval shape (not shown) can also be used to prevent unwanted rotation of the leaflet anchor 10.

[0333] The regulating catheter 21 passes through Fig.33 of the catheter device 2 and enters the distal end of the catheter device 2. As described above, the adjustment catheter 21 is capable of controlling the extension of the flexible joint 34 by means of the wire and / or rod 60. The same wire and / or rod 60 also pushes out the nipple anchor 9 for deployment. As described above, the nipple anchor 9 includes a plurality of pins 62 (which form a plurality of hooks in a non-constrained configuration), and further includes a locking segment 28 disposed within the wall of the nipple anchor 9. The nipple anchor 9 is housed within a nipple anchor housing 8. The adjustment housing 92 is further housed within the nipple anchor housing 8. The adjustment housing includes a piston 110, an anchor retainer 106, and a cam 91. In order to prevent unwanted deployment of the nipple anchor 9, a deployment locking mechanism 111 using a latch 113 may be disposed within the nipple anchor housing 8, such as Fig.34 As shown. The deployment lock mechanism 111 is actuated via a locking spring acting on a latch 113 and a deployment lock wire 112. The latch 113, the locking spring, and the deployment lock wire 112 can be formed of a suitable elastically deformable alloy (e.g., Nitinol). The latch 113 engages with a recessed groove 115 of the nipple anchor housing 8 to lock the adjustment housing 92 in place relative to the housing 8. The deployment lock wire 112 can be located within the adjustment catheter 21 for operating the latch 113. The deployment lock wire 112 extends from the latch 113 to the proximal end of the catheter device 2. The deployment lock wire 112 can also be enclosed in a flexible tube (not shown) that can help facilitate reengagement of the deployment lock wire with the latch 113 if desired.

[0334] Fig.35 The deployment locking mechanism 111 is shown in a locked position without the nipple anchor housing 8. A retaining pin 116 permanently constrains one end of the latch 113 into engagement with the nipple anchor housing 8 and acts as a pivot for the latch 113. The deployment locking wire 112 temporarily constrains the other end of the latch 113 into engagement with the chamfered cavity 114 of the anchor retainer 106, which covers the end of the nipple anchor 9 opposite its hook.

[0335] like Fig.36 As shown, the deployment lock wire 112 can be retracted. Once retracted, the deployment lock wire 112 no longer constrains the latch 113 to engage with the chamfered cavity 114 of the anchor holder 106. The locking spring can then move the latch 113 as described below.

[0336] exist Fig.36 , the latch 113 merely rests within the chamfered cavity 114 of the anchor holder 106 without the constraint from the deployment lock wire 112. When forward pressure from the wire and / or rod 60 within the adjustment catheter 21 is operated, forward pressure is applied to the anchor holder 106 and the nipple anchor 9, which in turn releases the anchor holder 106 from the latch 113. This is achieved due to the shape of the chamfered cavity 114 deflecting the latch 113 during the deployment movement. Advantageously, if the operator of the catheter device 2 wishes to reengage the deployment lock mechanism 111 with the anchor holder 106; the chamfer on the proximal end of the anchor holder 106 can deflect the latch 113 to reengage the chamfered cavity 114 in its resting position. The deployment lock wire 112 can then reengage the latch 113. In this way, the deployment lock mechanism 111 can be appropriately engaged and disengaged as needed to allow or prevent deployment of the nipple anchor 9.

[0337] It should be appreciated that the lock deployment line 112 may be used to constrain the latch 113 to the chamfered cavity 114, whereby the latch 113 alternatively has an undeformed position whereby it is not at rest within the chamfered cavity 114. However, if the latch 113 is in an open configuration when at rest, the ability to reengage the deployment locking mechanism 111 may be lost.

[0338] Fig.37 A cross-sectional view of the nipple anchor 9 is shown with the adjustment housing 92 mounted on top when not deployed. An anchor holder 106, a piston 110 and a cam 91 are contained within the adjustment housing 92. The piston 110 includes a fork wedge structure 95 configured to elastically deform the cam 91 and the nipple anchor 9, and a cutting wedge 96 configured to cut the cable 14 in conjunction with the cutting section 94 of the anchor holder 106. The fork wedge can be considered to have two main parts: a cam wedge, wherein at least one tine of the fork wedge 95 is used to open the cam 91; and a piston wedge, wherein at least one tine of the fork wedge 95 is used to open the locking segment 28. When the piston wedge and the locking segment are engaged, the tip of the piston wedge advantageously helps to deflect the locking segment 28, making engagement / deployment of the anchor 9 with the piston wedge easier. When the cam 91 is engaged with the fork wedge 95, the cam 91 elastically deforms the locking mechanism 28 of the nipple anchor 9 to an open position. In Fig.37In the configuration shown, the open locking mechanism 28 and the positioning of the piston 110 within the adjustment housing 92 allow the cable 14 to slide through with minimal friction. The cable 14 is attached to the leaflet anchor 10 (not shown) above the nipple anchor 9. In this configuration, the length of the cable can be easily adjusted. The piston 110 is ideally characterized by a piston wire position 97 that allows a pull wire (not shown) to be attached to the piston 110. The pull wire is ideally arranged to pass through the adjustment catheter 21 (in a separate cavity in the adjustment catheter 21) without passing through a path adjacent to the cutting wedge 96 and cutting section 94. When the piston pull wire is pulled, the piston 110 slides in a direction away from the nipple anchor 9.

[0339] Fig.38 A cross-sectional view of the nipple anchor 9 is shown when deployed, with the adjustment housing 92 mounted on top. During deployment, the piston 110 is slidably moved away from the nipple anchor 9. In this way, the piston's fork wedge 95 is no longer engaged with the cam 91 and the locking segment 28. The cam 91 is no longer elastically deformed and the cam 91 and the locking segment 28 of the nipple anchor 9 return to their resting / undeformed position. In this way, the cable 14 is locked in place and its length is no longer adjustable. At the same time, when the locking mechanism 28 returns to its undeformed position, the cutting section 94 and the cutting wedge 96 cut the cable 14. Thus, in one movement, the nipple anchor 9 can be deployed and the cable 14 is properly attached in place. By placing the piston cable in the piston cable position 97 above the cutting position, the piston cable can be avoided from being cut in the same action and thus the device is fully operational if readjustment is required.

[0340] In order to prevent the piston 110 from exceeding its desired range of motion, the piston 110 may be equipped with two stop features arranged at the upper and lower ends of the piston 110. In order to prevent the piston 110 from moving further than its upper position in the housing 92, a cutter wire (not shown) may be passed through the housing and / or the piston to stop the piston 110 in the upper position. Even if the cutter wire breaks, the piston 110 and the wire attached to the piston 110 operating it cannot be detached from the upper end of the housing 92 because both the piston 110 and the wire attached to the piston 110 operating it are contained within the housing 92. The cam 91 prevents the piston 110 from moving further than its lower position in the housing 92.

[0341] Figures 39 to 42 The interaction of the adjustment housing 92 with the nipple anchor 9 is shown in more detail.

[0342] Fig.39An adjustment housing 92 is shown mounted on top of the nipple anchor 9 when the hook of the nipple anchor 9 is unconstrained. The adjustment housing 92 can be formed of a material such as stainless steel or a composite material such as CRF PEEK or a combination in which the cutting edge can be stainless steel and the structural components can be composite materials. The fork wedge 95 of the piston 110 (which includes three legs in this embodiment, but can include one or more legs or tines) engages the locking mechanism 28 of the nipple anchor 9. The fork wedge 95 prevents the locking mechanism 28 from returning to its undeformed position and thus allows adjustment of the cable 14 passing through it. The cutting wedge 96 is disposed on one of the tines corresponding to the fork wedge 95.

[0343] Fig.40 The adjustment housing 92 is shown without the nipple anchor 9. The adjustment housing 92 includes the anchor holder 106, the piston 110 and the cam 91. The adjustment housing 92 is in an adjustment configuration, shown by the piston 110 engaging the cam 91 via the fork wedge 95 to elastically deform the cam 91 to the wide position. Fig.40 Also shown is the engagement portion 108 of the anchor holder 106. The engagement portion 108 is shaped so that it fits within the nipple anchor housing in a particular orientation, thereby restricting rotation.

[0344] Fig.41 9 is a bird's eye view of the cam 91 engaged with the nipple anchor 9 in a deformed position. The deformation is a result of the piston 110 engaging the cam 91 via the cam wedge portion of the fork wedge 95. The deformation of the cam 91 constrains the locking mechanism 28 of the nipple anchor to exhibit an ovoid shape. The ovoid shape of the locking mechanism 28 not only allows the strap 14 to pass through the locking mechanism 28 with minimal friction, but also creates a shape for the nipple anchor 9 that can be used to limit the rotation of the nipple anchor 9 when the nipple anchor 9 is disposed within the nipple anchor housing 8.

[0345] Fig.42 is a bird's eye view of the cam 91 in its undeformed position. In this configuration, the piston 110 is not engaged with the cam 91. Thus, the cam 91 is not engaged with the locking mechanism 28 of the nipple anchor 9. The locking mechanism 28 matches the tubular shape of the nipple anchor 9 when undeformed.

[0346] Fig.43 Two perspective views of the nipple anchor 9 with the adjustment housing 92 mounted on top, and three perspective views of the nipple housing 8 are shown. The engagement portion 108 of the anchor holder 106 features an oval cross-section with beveled edges. During the insertion of the nipple anchor 9 into the nipple anchor housing 8, the curved inner shape of the nipple anchor housing 8 deflects the engagement portion 108 due to the complementary curved shape. Thus, the nipple anchor 9 orients itself so that the oval shape of the locking segment 28 will then engage with the complementary inner shape of the nipple anchor housing 8.

[0347] exist Fig.43 , from the distal end of the nipple anchor housing 8, the internal shape of the nipple anchor housing 8 can be clearly seen. Towards the proximal end, the shape complementary to the engagement portion of the anchor housing 106 tapers from an oval shape complementary to the locking mechanism 28. The funnel shape helps deflect the engagement portion 108 of the anchor housing 106, making it easy to achieve the correct orientation for inserting the nipple anchor 9 into the nipple anchor housing 8. The funnel shape allows relatively large rotational misalignments to be corrected before the anchor holder 106 engages with the corresponding slot in the nipple anchor housing 8, which greatly limits rotational movement.

[0348] The specific shape of the locking mechanism 28, the engagement portion 108 of the anchor holder 106, and the internal shape of the nipple anchor housing 8 limit the rotation of the nipple anchor 9. Limiting the possible rotation of the nipple anchor 9 advantageously ensures proper alignment of the nipple anchor 9 with the target deployment position. In addition, the engagement portion 108 of the anchor holder 106 can have a chamfered feature to help make it easier to insert the anchor holder 106 into the distal portion 8 of the catheter device 2.

[0349] Limiting rotation of the nipple anchor 9 may also help prevent twisting of the cable 14 , the lock deployment line 112 , the piston pull line, and the wire / rod 60 used to deploy the nipple anchor 9 .

[0350] A plurality of wires for deploying the nipple anchor 9, such as a locking deployment wire 112, a piston pull wire, and a wire / rod 60, are provided in the distal portion 8 of the catheter device 2 to ensure proper function of the device 2. However, since the distal portion 8 of the catheter device 2 is actuable to bend and / or extend, slack may be introduced into some or all of the wires / rods used within the device 2 to operate various components thereof. This may result in wire entanglement, which may affect proper function of the device 2. In order to ensure that the wires / rods remain taut, a constant tension device may be used within the device 2. The constant tension device may be provided in a handle for operating the device 2. Examples of constant tension devices include, but are not limited to, constant force springs.

[0351] The constant tension device as described above can also be implemented for use with a U-shaped rod wire 30 disposed in the proximal portion 4 of the catheter device 2, which is still easy to spool due to the bending or turning of the axis of the device 2. Similarly, the constant tension device as described above can be implemented for use with the synthetic cord 14 when the synthetic cord 14 is disposed in the device 2 before adjustment and deployment.

[0352] Fig.44Another view of the nipple anchor 9 is shown when the piston 110 is engaged with the cam 91. The locking mechanism 28 is elastically deformed and protrudes from the wall of the nipple anchor 9. The oval shape of the protrusion serves to limit the rotation of the nipple anchor 9 within the nipple anchor housing 8. The inclined shape of the engagement portion 108 can also be seen, which assists in the deflection of the anchor holder 106 to ensure the correct orientation when the nipple anchor 9 is inserted into the nipple anchor housing 8. The key joint arrangement 120 can also be seen, which serves to guide the alignment of the nipple anchor 9 when the nipple anchor 9 is engaged with the anchor holder 106 of the adjustment housing 92. The circular tubular form of the exemplary nipple anchor 9 fits to the outer cylinder of the distal portion of the anchor holder 106 in a concentric arrangement. The cutout in the nipple anchor 9 can interlock with the protrusion on the anchor holder 106 to provide the key joint 120. It should be understood that the opposite arrangement of the cutout and protrusion can also be used.

[0353] Fig.45 108, further details of a possible advantageous feature of the distal portion 8 of the housing are shown. In this case, the housing includes a non-circular mating recess 118 in the nipple anchor housing 8, which may be formed to allow engagement with the oval shape of the locking segment 28, as discussed above. In order to allow guided engagement of the nipple anchor 9 with the anchor housing 108, a funnel-shaped section 117 is provided to facilitate rough alignment of the nipple anchor 9. Once engagement is complete, the keyway 118 prevents any rotation of the non-circular shaped nipple anchor 9 and / or anchor retainer 106 while it slides further along the nipple anchor housing 8 (i.e., the distal portion 8 of the housing). Fig.45 Another feature best seen in the nipple anchor housing 8 is the presence of a cable channel 124 that runs along the length of the nipple anchor housing 8. The channel 124 allows room for the cable wire 14 to be placed. Since it is formed via a slit along the length of the nipple anchor housing 8, it also acts to reduce the stiffness of the nipple anchor housing 8, thereby allowing some elastic deformation when the anchor 9 is engaged / reengaged. Advantageously, the cable channel 124 is placed in a thicker section 126 of the wall of the nipple anchor housing 8, which is formed due to the non-circular shape of the depression within the housing 8 and the eccentric placement of the non-circular shape, i.e., eccentric relative to the center of the outer shape of the nipple anchor housing 8.

[0354] Fig.46How a hinge pull wire 204 is arranged for actuating a hinge element 104 of a flexible joint 34' of a catheter device 2. Although a single hinge pull wire 204 is shown in the figures, more than one hinge pull wire 204 may be used to achieve the desired operation of the hinge element 104 of the flexible joint 34'. The hinge pull wire 204 passes through the shaft of the catheter device 2, through the proximal portion 4 of the two-part housing section and reaches the hinge element 104, which is configured to angle the centerline of the distal portion 8 of the catheter device relative to the centerline of the proximal portion 4. As described above, the hinge pull wire 204 that actuates the device can advantageously pass around the hinge element 104, which provides a low friction transition in the pulling direction.

[0355] As in Fig.46 As can be seen in the figure, the hinge wire 204 is offset from the center relative to the catheter device 2 and is instead arranged near the wall of the catheter device 2. Therefore, the hinge wire 204 is guided to be located inside the front side of the device 2, that is, the side of the catheter device 2 where the mechanical clamping device 6 is arranged. In order to angle the distal portion 8 of the catheter device 2, the hinge wire 204 is pulled. By positioning the hinge wire 204 inside the front side of the device 2, the axis of the catheter device 2 is also deflected in the direction in which the distal portion 8 is angled relative to the proximal portion 8. During the operation of the hinge wire 204, the actuation of the hinge element 104 and the deflection of the device 2 can be sequential or simultaneous. For example, during the operation of the hinge wire, the device axis can be deflected at the same time as the hinge element is bent, or during the operation of the wire, first, the hinge element can be bent, and secondly the device axis can be deflected. Advantageously, when the distal portion 8 of the device 2 is angled, the axis of the device 2 can therefore be turned by the hinge wire 204. Additionally, this helps ensure that the distal portion 8 is positioned perpendicular to the target wall of the heart during anchor deployment.

[0356] Fig.47A and Fig.47B An exemplary knot is shown that can be used to attach a synthetic cord 14 to a leaflet anchor 10. The leaflet anchor 10 can be in accordance with any of the embodiments of the leaflet anchor 10 discussed herein. The knot particularly shown is self-locking, i.e., a stable knot is formed when tension is applied from the end of the synthetic cord 14 that is not attached to the leaflet anchor 10. The exemplary self-locking knot shown in the figures can increase the tensile strength of the leaflet anchor 10 connection by up to 2.5 times compared to the tensile strength of an anchor 10 implementing a conventional knot.

[0357] An anchor hole 65 located in the base of the anchor 10 accommodates the knot. The hole 65 allows for many threading patterns that impart a significant amount of friction to the synthetic cord 14. The friction imparted by the leaflet anchor 10 reduces the variation of the synthetic cord 14 slipping out of the anchor hole 65. Over time, tissue grows inward within the anchor base, thus the knot improves the strength of the knot over time.

[0358] like Fig.48A and Fig.48B As shown, the piston wedge of the piston 110 can be arranged so that the piston wedge never contacts the inner wall 9' of the nipple anchor 9. When the locking segment 28 is required to be in the open position (for example, to adjust the synthetic line length 14), the piston wedge engages the locking segment 28 and does not engage the nipple anchor wall 9'. Advantageously, there is less friction between the piston 110 and the nipple anchor 9 because there is less contact surface area between the piston wedge and the nipple anchor wall 9' than if the piston wedge were in contact with the wall 9'. Therefore, during deployment of the nipple anchor from the anchor holder 110, the piston wedge does not move with the anchor 9, thereby ensuring that the piston wedge is disengaged from the locking segment 28 in the desired manner.

[0359] Still refer to Fig.48A and Fig.48B In the illustrated embodiment, due to the elasticity of the locking segment 28, the locking segment 28 exerts a contact force on the piston wedge, which may cause the piston 110 to move so that the piston wedge contacts the nipple anchor wall 9'. To overcome this undesirable force, the piston 110 is arranged in the anchor holder 106 so that the piston 110 acts as a cantilever, thereby preventing the piston wedge from being pulled toward the nipple anchor wall 9'. To ensure that the piston wedge does not bend toward the locking segment 28 due to the reaction force of the cantilever action (provided by the piston 110 in response to the force applied by the locking segment 28), the piston 110 and the piston wedge may be made of a suitably rigid material. As will be readily appreciated, as Fig.48A and Fig.48B The piston 110 of the illustrated embodiment is compatible with any other embodiment involving the piston 110 and its features discussed herein.

[0360] As described herein, it may be necessary to pull the wire, rod and / or suture to operate and / or adjust in the catheter device 2. Some operations that these components are designed to perform may require limited force. In order to help the operator of the device 2 know when such force is applied to these components, a clutch can be used, and when a certain torque is released, the clutch releases. In various embodiments, it is valuable to allow the operator to know when the clutch is engaged. When the clutch is therefore a ratchet clutch, the operator can be notified that the clutch is engaged because the clutch produces an audible click. The type of clutch that can be implemented in the present invention is not limited to a ratchet clutch, and can actually be any known clutch compatible with the embodiments described herein. For example, an O-ring squeeze clutch can be implemented. In this example, when a certain torque is reached, the clutch releases to prevent further force from being applied to the wire, rod and / or suture engaged therewith.

[0361] like Fig.49A and Fig.49B As shown, anchor 9 is in a folded configuration. Fig.49AThe anchor 9 is shown with a tip 160 that is not curved towards the central axis of the anchor 9, Fig.49B The anchor 9 is shown having a tip 160 ′ that is bent towards the central axis of the anchor 9 . Fig.50A and Fig.50B It is shown how the hook 62 of the anchor 9 is shaped in the unfolded configuration. Fig.50A It shows that Fig.49A The tip 160 is in an unfolded configuration, while Fig.50B It shows that Fig.49B The unfolded configuration of the curved tip 160'.

[0362] focus on Fig.49B The anchor 9 shown includes a plurality of hooks 62 extending from the base 109 of the anchor to the distal end of the anchor. The end of each hook 62 includes a tip 160'. The hook may also have an opening 64 extending along its length. The tip 160' is bent toward the central axis of the anchor 9 so that when the anchor 9 is constrained by the restraining force of the container device (e.g., the distal portion 4 of the catheter device 2 as described above) in its folded configuration, Fig.49B The tip 64 of the container tube does not contact the inner wall of the container device at its tip. Instead, the contact point between the container tube and the anchor 9 is a tangential contact between the tip 160' and / or the hook 62, so that a smoother portion creates contact between the anchor 9 and the container device. When a smoother contact is formed, less force is required to eject the anchor 9 from its housing during implantation into the target body tissue. In addition, the inward curvature of the tip 160' prevents abrasions and / or scraping between the tip 160' and the inner surface of the container device. This in turn prevents the generation of scrapings of the material from which the container device is made, which scrapings may be deposited in the area surrounding the target body tissue, which may otherwise cause bleeding and / or embolism that may cause a stroke. The generation of scrapings is most prevalent when the container device is made of a softer material than the anchor 9. For example, this problem occurs when the container device is made of CRF PEEK and the anchor 9 is made of Nitinol or stainless steel.

[0363] As in Fig.49B 9, the curvature of the tip 160' that bends back toward the central axis of the anchor 9 can help ensure that the tip 160 is perpendicular to the surface of the target body tissue in which the anchor is to be implanted. This minimizes the axial force required to implant the anchor 9 because the force pushing the anchor 9 into the body tissue is more effectively transmitted to the tip 160' of the anchor 9. The force pushing the anchor 9 can be applied by an anchor container tube that includes a plurality of wires and / or rods 60 as described above. The anchor 9 can be deployed via a mechanism as described herein with reference to other figures, such as a mechanism including an anchor retainer 106 and / or a piston 110 as discussed above.

[0364] Although Fig.49BThe curvature of the tip 160' seen in the figure is shown as being vertical, but it will be understood that the tip 160' of the anchor 9 can be angled relative to the surface of the target body tissue in which the anchor is to be implanted, i.e., curved toward the central axis of the anchor 9. Thus, the curvature of the tip 160' can be in the range of 0 to 30 degrees from the normal to the surface of the target body tissue in which the anchor 9 is to be implanted. In various embodiments, the curvature of the tip 160' can take values ​​ranging from 0 to 5 degrees, 0 to 10 degrees, 0 to 15 degrees, 0 to 20 degrees, 0 to 25 degrees, or 5 to 15 degrees.

[0365] During implantation, the curvature of the hook 62 and the tip 160' of the anchor 9 assists in pulling the anchor 9 through the target body tissue. This effect is achieved due to the "rebound" force exhibited by the anchor 9 when it is deployed from its folded configuration to its unfolded configuration. When the tip 160' exhibits a curvature toward the central axis of the anchor 9, the hook 62 is pulled through the tissue during deployment of the anchor 9. As a result, the force required during implantation of the anchor 9 into the target body tissue is reduced. It should be appreciated that the advantages obtained by angling the tip 160' of the anchor 9 relative to perpendicular to the surface of the body tissue for implantation are taken into account, so that the force required to implant the anchor can be effectively reduced.

[0366] Unless a large amount of axial force is applied to the anchor 9 during implantation, the anchor 9 will not be deformed in the collapsed configuration (e.g. Fig.49A The anchor 9 of the hook 62 that does not bend back toward the central axis (as shown) tends to bend immediately back to its unfolded configuration (as shown Fig.50A ) without penetrating the target body tissue to any particular distance. However, when the tip 160 'of the hook 62 is moved to its unfolded configuration (as shown), the hook 62 is moved to its unfolded configuration (as shown). Fig.50B Before the tip of the tip begins to bend outward from the central axis (as shown in FIG. Fig.49B and 50B The anchor 9 with the hook 62 of the tip 160' will tend to penetrate a greater distance into the target body tissue because the inward curvature of the tip 160' causes the first penetration of the tissue to be inward and / or parallel to the axis of the anchor 9. Therefore, a reduced axial force needs to be applied to the anchor 9 from the container device to cause the initial penetration of the anchor 9, and in some cases, as long as the distal end of the container device is in contact with the surface of the target body tissue, there may be no force acting on the deployment of the anchor 9 to act to pull it into the tissue. The resilient force of the anchor 9 caused by the inward curvature of the tip 160' promotes the trajectory of the hook 62 of the anchor 9, which causes the anchor 9 to move along a deeper curve into the tissue, thereby causing the pulling effect described.

[0367] The curvature of the tip 160' that prevents contact between the tip of the tip 160' and the inner surface of the container tube can be best described as follows. Fig.49BIn the folded configuration, the hook 62 has a first curvature extending toward the central axis of the anchor 9. Then, the hook 62 and the tip 160 have a second curvature extending away from the central axis of the anchor 9. Finally, there is a third curvature where the tip 160' bends back toward the central axis of the anchor 9 so that the tip of the tip 160' is angled away from the inner surface of the container tube that applies the restraining force. In this way, the curvature of the hook 62 exhibits at least one inflection point. In other words, the curvature of the tip 160 and / or the hook 62 can be described as at least one of a reverse curvature, an opposite curvature, or an S-shaped curvature.

[0368] When in the unfolded configuration, such as Fig.50B As shown, the hooks 64 extend away from the central axis of the anchor 9 in a grabber-type shape. In the unfolded configuration, these hooks have a curvature with at least one inflection point, and the direction of the curvature of the hook is reversed at the tip 160', having the same shape as that used for Fig.50A Alternative shapes of anchors 9 with different curvatures, as shown by comparison Fig.50A and Fig.50B The surrounding part can be seen.

[0369] If you can also Fig.50A and Fig.50B As seen in Fig.50B The hook 62 of the anchor 9 shown in the unfolded configuration covers more than in Fig.50A The greater planar extent of the hook 62 of the anchor 9 shown in the unfolded configuration of FIG. By requiring the tip 160' to bend as described above when deployed, the surface area covered by the unfolded anchor 9 is increased. This spreads the force applied by the anchor 9 to the body tissue into which it is to be implanted over a greater area and thus reduces the strain on the tissue during implantation of the anchor.

[0370] like Fig.49A , Fig.49B , Fig.50A and Fig.50B As shown, the tips 160, 160' can be shaped so that the widest portion of the tips 160, 160' is wider than the front portion of the hook 62. When tissue re-grows around the anchor 9 once implanted, the tissue can re-grow around the hook 62 extending through the body tissue. Since the widest portion of the tips 160, 160' is wider than the front portion of the hook 62, a greater force is required to remove the implanted anchor 9. This advantageously strengthens the implantation of the anchor 9.

[0371] The shape of the tip 160, 160' can be described as a teardrop, leaf or petal shape. That is, the tip 160, 160' includes a generally oval body having a pointed tip for engaging body tissue during implantation of the anchor 9. The oval body is preferably adjacent to the hooks 62, with the pointed tip at the distal end of the anchor 9.

[0372] Although the shape of the tip 160, 160' is as described above Fig.49A , Fig.49B , Fig.50A and Fig.50B 1 , but the tip 160, 160' may alternatively include a taper extending from the hook 62 to the end of the tip 160, 160'.

[0373] Although in Fig.49A , Fig.49B , Fig.50A and Fig.50B 9, but the anchor 9 may include any other features applicable to the anchor 9 discussed herein. For example, the opening 64 need not be limited to the opening 64 shown in the drawings. In addition, the base 109 of the anchor 9 may include a locking segment 28 as described herein.

[0374] Fig.51 A device handle 200 for operating and controlling a catheter device 2 and a steerable introducer (not shown) for the catheter device are shown. The device handle 200 includes a frame 202 on which one or more carriages 206, 206', 206". The carriages 206, 206', 206" provide a plurality of supports to which one or more operating handles 220, 221, 222 can be mounted. The operating handles 220, 221, 222 are in turn used to actuate one or more pull wires contained within a pull wire sheath 224 of the catheter device 2 to control the function of the catheter device 2 as described above. The pull wire sheath 224 can be a catheter, such as a 24 French catheter or any other size suitable for use with the catheter device. The pull wire disposed within the pull wire sheath 224 can pass through the wall of the pull wire sheath 224 or be disposed along its center, as required by the desired function of the pull wire. The pull wire sheath 224 can be steerable and can therefore be a steerable catheter.

[0375] Fig.51The rack 202 shown in FIG. 1 includes a base structure to which at least two supports are mounted. A first support 203a is located at a distal end of the rack 202, while a second support 203b is located at a proximal end of the rack 202. The supports 203a, 203b provide a mounting surface for a track 203c. Although it can be seen that the second support 203b is located at a greater elevation from the surface of the rack 202 than the first support 203a, it can be readily appreciated that a variety of support shapes and structures may be used to provide a mounting surface for the track 203c. The track 203c provides a support structure onto which the carriages 206, 206', 206" can be slidably mounted. It will be readily appreciated that a variety of suitable arrangements of the rack 202 can be implemented in the device handle 200 of the catheter device 2. For example, the rack 202 can include more than two supports 203a, 203b, and the track 203c can take a variety of configurations, as long as the carriages 206, 206', 206" can be slidably mounted on the track 203c.

[0376] Although in Fig.51 Three carriages 206, 206', 206" are shown in the figure, but any number of carriages 206, 206', 206" may be used in the device handle 200 as appropriate. Attention is now directed to a single carriage 206, which is formed from a single sheet of metal. The carriage 206 includes a curved shape, with a first portion of the carriage 206 being perpendicular to a second portion of the carriage 206. The first carriage portion may lie in a plane parallel to the plane of the track 203c and include a plurality of legs that allow the carriage 206 to be slidably mounted to the track 203c. The carriage 206 may then be clamped to the rail 203c using thumb screws 207 to prevent the carriage 206 from moving from its desired position. Thus, in Fig.51 During assembly (and vice versa for disassembly) of the delivery handle 200 shown, the carriage 206, 206', 206" can be slid from the proximal end of the frame 202 onto the track 203c. The thumb screws 207, 207', 207" are then tightened to clamp the carriage 206, 206', 206" in their respective positions. Advantageously, this allows the carriage 206, 206', 206" to be installed and / or removed from the frame 202 without the use of any special tools. These components of the device handle 200 can then be relatively easily removed for sterilization after any operation or procedure.

[0377] Still referring to the single carriage 206, the second portion of the single sheet of metal may be perpendicular to the first portion. The second portion may include a groove of semicircular, oval or any other suitable cross-section at its end farthest from the bend in the carriage 206, to which a plurality of clamping devices may be attached. The second portion of the carriage 206 may also include a flange disposed adjacent to the groove, the flange being configured to receive a thumb screw 217. These clamping devices may include a plurality of washers, O-rings and / or clamps that themselves provide support for the cable sheath 224 and the operating handles 220, 221, 222. In addition to or as an alternative to washers, O-rings and / or clamps, a plurality of disks 216, 216', 216" including circular grooves may be arranged around the cable sheath 224 and positioned on the grooves of the respective carriages 206, 206', 206". A thumb screw 217, 217', 217" may pass through the flange of each carriage 206, 206', 206" to limit the rotation of each disc 217, 217', 217" and, therefore, constrain the rotation of the cable sheath 224 if desired.

[0378] Now turn to Fig.51 220, 221, and 222, a plurality of spacers and washers, O-rings, and / or clamps rigidly hold the operating handles 220, 221, 222 in their desired positions along the pull wire sheath 224. The spacers and washers, O-rings, and / or clamps themselves may also be disposed around the pull wire sheath 224. Although three delivery handles 220, 221, 222 are shown mounted on the delivery handle 200, it is readily understood that any number of delivery handles 220, 221, 222 may be mounted in the delivery handle 200 to achieve the desired operation of the catheter device 2 and the associated introducer.

[0379] Of interest is the illustrated operating handle 220 mounted between the first carriage 206 and the second carriage 206', which may include a plurality of gears and / or dials 226a, 226b, 226c. Each gear and / or dial 226a, 226b, 226c may control the actuation of a pull wire disposed in a pull wire sheath 224. The operating handle 220 is used, for example, to control the steering action of the steerable guide by a pull wire actuated by any one of the gears and / or dials 226a, 226b, 226c, and is part of a steering control mechanism or a torsion control mechanism for the steerable guide.

[0380] The arrangement of the operating handles 220, 221, 222 can be changed to accommodate the user's preferences and to coincide with the desired procedure. For example, instead of controlling the wire for the steerable introducer, the pull wire actuated by any of the gears and / or dials 226a, 226b, 226c can be (but not limited to) the pull wire 204 that operates the hinge element 104 of the catheter device 2, etc. Similarly, the gears, dials and other control inputs for the operating handles 221 and 222 can control various elements of the catheter device 2. In one arrangement, the proximal operating handle 220 controls the advancement of the steerable introducer and the catheter device 2, the intermediate operating handle 221 controls various functions of the catheter device 2 related to the capture of the leaflets and the implantation of the leaflet anchors, and the proximal operating handle 222 controls further operations related to the implantation of the synthetic cable 14, such as the adjustment and / or cutting of the cable 14. Additionally, the relative positions of the operating handles 220, 221, 222 on their respective carriages 206, 206', 206" can be varied to move elements of the device at the distal end of the 24French 224, for example to slide the proximal carriage 206" to advance the papillary anchor 9 and thereby implant it into the papillary muscle.

[0381] In order to indicate the amount of tension and / or deflection applied to each pull wire controlled by the gears and / or dials 226a, 226b, 226c of the catheter device, a plurality of indicators 227a, 227b, 227c may also be provided on the outer surface of the operating handle 220. These may be used as feedback indicators to indicate to the operator of the catheter device 2 how much tension is currently applied to the pull wires and their current behavior / positioning. These indicators 227a, 227b, 227c may be used in addition to and / or in place of the various clutch configurations discussed above.

[0382] Although the functionality of the operating handles has been discussed with respect to only a single operating handle 220 , it will be readily appreciated that some or all of the features discussed herein may be applied to the other operating handles 221 , 222 of the delivery handle 200 .

[0383] Fig.52A and Fig.52BThe body of the catheter device 2 is shown. The body includes a proximal portion 4 and a distal portion 8, which are connected to each other at a hinge element 104. The distal portion 4 can accommodate the nipple anchor 9 as discussed above and as shown in the previous figures. The hinge element 104 can operate as discussed above with reference to the flexible joint and as shown in the previous figures. The guide wire 1 passes through the catheter device 2 and extends out of the distal portion 8. The body of the catheter device 2 can be formed of a composite material, such as glass reinforced PEEK or carbon reinforced PEEK. The proximal portion 4 of the catheter device 2 can be connected to the steerable catheter of the catheter device 2 by reflowing the polymer at the location of the joint.

[0384] Focusing on the proximal portion 4 of the catheter device 2, the mechanical clamping device 6 can be seen. The mechanical clamping device 6 comprises a first clamping arm 30 and a second clamping arm 32, wherein the mechanical clamping device 6 is according to one of the previously discussed embodiments. Fig.52A A first clamp arm 30 and a second clamp arm 32 are shown moved away from the body of the catheter device 2. The mechanical clamp device 6 can be configured so that the first clamp arm 30 moves to meet the second clamp arm 32. The first clamp arm 30 can move until contact is formed between the two arms 30, 32. With the second clamp arm 32 configured to be placed on top of the leaflet 10 to inhibit its movement, the first clamp arm 30 can then be rotatably moved back into the proximal portion 4 of the body of the catheter device 2. In this way, the first clamp arm 30 is able to grasp the constrained leaflet 10 between itself and the body of the catheter device 2. According to any of the embodiments discussed above, the leaflet anchor 10 can be housed within the first clamp arm 30.

[0385] like Fig.52A and Fig.52B As shown, the second clamp arm 32 can be a leaflet motion inhibitor 32 including a wire loop. The wire can be made of a suitable elastic material, such as nitinol or stainless steel. Therefore, when the leaflet motion inhibitor 32 is not housed in the body of the catheter device 2, the leaflet motion inhibitor 32 is in an undeformed state. The elasticity of the leaflet motion inhibitor 32 allows the leaflet motion inhibitor 32 to inhibit the movement of the leaflets 10 during the cardiac cycle, while allowing the first clamp arm 30 to contact the leaflet motion inhibitor 32 without damaging the leaflets 10 constrained between the two arms 30, 32. When the leaflet motion inhibitor 32 contacts the first clamp arm 30, the elasticity of the leaflet motion inhibitor 32 allows the leaflet motion inhibitor 32 to be deformed. Fig.52B The bend shown helps to avoid any pinching of the leaflet 10, which could result in damage to the leaflet 10 when the leaflet 10 is constrained.

[0386] The leaflet motion inhibitor 32 can be received within a lumen (not shown) of the catheter device 2. When received within the lumen, the leaflet motion inhibitor 32 comprises an elastically deformed state. The lumen can extend parallel to the main axis of the catheter device 2 before being angled to encounter the surface of the proximal portion 4 adjacent to the location of the mechanical clamping device 6. The lumen can be angled so that the leaflet motion inhibitor is angled, such as Fig.52A and Fig.52B shown.

[0387] The loop formed in the loop of the wire can prevent the leaflet motion inhibitor 32 from being fully withdrawn into the catheter device 2. For example, the end of the cavity can feature a pin that extends through the opening of the cavity located at the surface of the proximal portion 4. When the pin is slidably moved into the catheter device, the loop of the wire can engage with the pin, thereby preventing the leaflet motion inhibitor 32 from being further withdrawn into the catheter device 2. Thus, the loop of the wire can be moved from a position flush with the outer surface of the proximal portion 4 to a position away from the body of the catheter device 2, such as Fig.52A and Fig.52B shown.

[0388] Fig.53A , Fig.53B and Fig.53C The leaflet motion inhibitor 32 is shown engaged with the leaflets 12 of the model mitral valve at various stages of its operation. For example, the catheter device 2 can enter the mitral valve from a top-down approach (i.e., from the left atrium into the left ventricle). Fig.53A As shown, the leaflet motion inhibitor 32 slides out of its cavity and engages the top surface of the leaflet 12. The ring extends over a suitably large distance so that there is sufficient contact between the leaflet 12 and the leaflet motion inhibitor 32. The first gripper arm 30 remains closed. The catheter device 2 is then moved downward through the mitral valve before the first gripper arm 20 is rotated outward away from the body of the catheter device 2, as shown in FIG. Fig.53B As shown. Finally, the first clamp arm 30 can be moved toward the leaflet motion inhibitor 32 so that the leaflet 12 is firmly restrained by the mechanical clamp device 6 by the contact force between the leaflet motion inhibitor 32 and the first clamp arm 30. The contact can be a slidable contact so that in the mechanical clamp device 6, before the leaflet 10 is subsequently captured between the first clamp arm 30 and the body of the catheter device 2, the first clamp arm 30 can then be rotated back toward the body of the catheter device 2, and the leaflet 10 is still restrained. The leaflet anchor 10 (as in the previous figures) can then be deployed and implanted in the leaflet 12, wherein the movement of the leaflet 12 is inhibited during the clamping movement.

[0389] Although Fig.53A , Fig.53B and Fig.53CA leaflet motion inhibitor 32 comprising a ring of wire is shown, but the leaflet motion inhibitor 32 may include a variety of shapes and / or arrangements to achieve its intended function. For example, Fig.54A , Fig.54B and Fig.54C An alternative embodiment of a leaflet motion inhibitor 32' is shown, which comprises an open-ended wire segment, the ends of which are located outside the body of the catheter device 2. As described above, Fig.54A , Fig.54B and Fig.54C The overarching principle of the leaflet motion inhibitor 32' shown in FIG. Fig.53A , Fig.54B and Fig.54C The overarching principle of the leaflet motion inhibitor 32 shown in FIG.

[0390] In order to prevent the leaflet motion inhibitor 32' comprising a single wire segment from being completely withdrawn into the catheter device 2 when it is slidably moved back into the cavity that accommodates it, a wire stopper (not shown) may be provided at the end of the wire located outside the body of the catheter device 2. It should be understood that the wire stopper needs to have a shape that is appropriately larger than the opening formed by the cavity so that the wire stopper cannot be accommodated within the cavity.

[0391] When the leaflet motion inhibitor 32' is withdrawn into the cavity, the leaflet motion inhibitor 32' will elastically deform from its undeformed state to its elastically deformed state.For example, the wire may straighten and may take on the shape of the cavity in which it is received.

[0392] Fig.54A , Fig.54B and Fig.54C The leaflet movement inhibitor 32' shown in includes a spiral shape toward the end of the wire. The spiral shape provides a larger surface area for engagement with the leaflet 12. In addition, the end of the wire can be located at the center of the spiral. This closes the end of the wire, making it less likely that the end of the wire will pierce and / or damage the tissue it contacts. The spiral shape can be described as a pigtail shape. When a restraining force is applied (i.e., by the inner wall of the cavity), the wire can straighten, but when the restraining force is removed (i.e., the wire is moved out of the cavity and the end of the wire moves away from the body of the catheter device), the wire can be coiled into the spiral shape shown in the accompanying drawings.

[0393] Fig.55A , Fig.55B and Fig.55CAlternative arrangements of leaflet motion inhibitors 32' are shown, each of which can be implemented similarly to the examples described above. As shown in the figures, the leaflet motion inhibitor 32' can include multiple bends and / or curves that increase its effective surface area for engagement with the leaflet 12. In its undeformed state, the line segment shows the bends and / or curves it forms. However, when withdrawn into the cavity, it should be understood that the elastic wire deforms and straightens to assume a shape complementary to the structure of the cavity. Including open-ended wires (such as Figures 54A to 55C The leaflet motion inhibitor 32' of FIG. 1 (shown) may include a soft tip at the end of the wire to reduce the likelihood of the wire piercing and / or damaging surrounding tissue (eg, leaflet 12).

[0394] The wire components of the leaflet motion inhibitors 32, 32' can be off-the-shelf wires, such as guide wires, which are readily available for cardiac interventions. Thus, the operator of the catheter device 2 can then select a wire that they find suitable for inhibiting the movement of the leaflet 12 during surgery. In other words, different wires of the same predetermined size can be implemented with different hardnesses and / or tip structures (i.e., bends, curves and / or loops), as needed. For example, if the first wire does not work as desired, a second wire with similar or different properties can be used. In this way, the leaflet motion inhibitors 32, 32' may not be stored in the cavity of the catheter device 2, but rather may be selected from a storage device and inserted into the port of the catheter device 2 during a particularly challenging insertion of the leaflet anchor 10 into the leaflet 12.

Claims

1. A catheter device for implanting a papillary anchor into a heart to attach an artificial cable to the heart, the catheter device comprising: a housing section extending from a distal end of the catheter device along a length of the catheter device toward a proximal end of the catheter device, the housing section comprising a distal portion at the distal end of the catheter device and a proximal portion located proximally of the distal portion; an anchor deployment mechanism at the distal portion of the housing segment for deploying the nipple anchor to attach the nipple anchor to the heart, wherein the anchor deployment mechanism is arranged to deploy the nipple anchor from a stowed position of the nipple anchor by moving the nipple anchor outwardly in the distal direction relative to the distal portion; the nipple anchor being held in its stowed position by the anchor deployment mechanism in the distal portion prior to deployment, wherein the nipple anchor is for implantation in a papillary muscle to hold the synthetic cord, the nipple anchor comprising a plurality of hooks for engagement with the body tissue and having a folded position and an unfolded position, wherein the nipple anchor is made of an elastic material such that the hooks can be elastically deformed to the folded position by application of a restraining force and will return to the unfolded position when no restraining force is applied, and wherein the hooks are held in the folded position when the nipple anchor is in the stowed position within the distal portion; Wherein, the distal portion of the shell has a non-circular shape for engaging with a corresponding non-circular form of the nipple anchor and / or the anchor deployment mechanism, so that: when the nipple anchor is retained in the distal portion, due to the engagement between the non-circular shape and the non-circular form, the movement of the nipple anchor is limited relative to the rotation of the nipple anchor around the longitudinal axis of the distal portion.

2. The catheter device according to claim 1, wherein The non-circular shape is a shape formed within the interior of the distal portion around a recess for accommodating the nipple anchor and the anchor deployment mechanism when the nipple anchor is in the stowed position.

3. The catheter device according to claim 1 or 2, wherein: The nipple anchor includes a locking mechanism having an elastically deformable locking segment for locking the synthetic cable in place after the nipple anchor is deployed, wherein the anchor deployment mechanism is arranged to: when the nipple anchor is retracted within the distal portion, maintain the locking segment in a deformed position, and wherein, when the locking segment is in the deformed position, the locking segment adopts a non-circular form that engages with a portion of the non-circular shape of the distal portion of the catheter device.

4. The catheter device according to claim 3, wherein: When the locking segment is not deformed, the locking segment is tubular and aligned with the tubular wall of the nipple anchor, and the deformation of the locking segment causes the locking segment to move out of alignment with the tubular wall of the nipple anchor and form the non-circular form that engages with the associated portion of the non-circular shape of the distal portion.

5. The catheter device according to claim 4, wherein: The nipple anchor has a circular tubular wall, wherein the deformed locking segment has a non-circular form having an oval shape, wherein portions of the locking segment protrude outwardly beyond the tubular wall of the nipple anchor; And wherein the distal portion of the catheter device includes a corresponding oval shape as part of its non-circular shape.

6. The catheter device of claim 1, wherein: The distal end of the nipple anchor and / or the distal portion is arranged to be elastically deformed during engagement of the nipple anchor with the distal portion so as to allow guided engagement.

7. The catheter device of claim 1, wherein: The anchor deployment mechanism and / or the distal end of the distal portion may have a varying width to guide engagement.

8. The catheter device of claim 1, wherein: The anchor deployment mechanism includes an adjustment housing that retains the nipple anchor during deployment and facilitates adjustment of the wire.

9. The catheter device of claim 8, wherein: The exterior of the adjustment housing has a non-circular form, and a portion of the non-circular shape of the distal portion of the catheter device is arranged to engage the exterior of the adjustment housing to limit rotation of the adjustment housing.

10. The catheter device according to claim 8 or 9, wherein: The nipple anchor and the adjustment housing are arranged to engage with each other via circular portions for concentric engagement with each other, the circular portions comprising a keyed joint to ensure proper alignment during the concentric arrangement.

11. The catheter device according to claim 8 or 9, wherein: The distal portion has a non-circular shape arranged to engage with both the non-circular form of the nipple anchor and the non-circular form of the adjustment housing, wherein the non-circular shape of the distal portion has a first portion for engaging with the nipple anchor and a second portion for engaging with the adjustment housing.

12. The catheter device of claim 11, wherein: The catheter device is arranged so that: during the re-engagement of the nipple anchor with the distal part, the engagement of the non-circular form of the nipple anchor with the relevant part of the non-circular shape of the distal part is achieved by elastic deformation of the nipple anchor and / or the distal end of the distal part so as to cope with a relatively high degree of rotational misalignment, and during the re-engagement of the adjustment shell with the distal part, the engagement of the non-circular form of the adjustment shell with the relevant part of the non-circular shape of the distal part is achieved by less elastic deformation or no elastic deformation.

13. The catheter device of claim 11, wherein: The catheter device is arranged to: first, correct relatively large rotational misalignment by allowing reengagement of the nipple anchor with the distal portion via the relatively high elasticity of the non-circular form of the nipple anchor, and secondly, reengage the exterior of the adjustment shell with the distal portion to prevent the nipple anchor from rotating within the distal portion due to the relatively more rigid form of the adjustment shell compared to the nipple anchor, thereby facilitating reengagement of the nipple anchor and the anchor deployment mechanism with the distal portion.

14. The catheter device of claim 11, wherein: The first portion of the non-circular shape of the distal portion of the catheter device extends a first distance in the distal direction from the fully retracted position of the nipple anchor toward the distal end of the device; the second portion of the non-circular shape of the distal portion of the catheter device extends a second distance in the distal direction from the fully retracted position of the adjustment shell toward the distal end of the device; and the first distance is greater than the second distance.

15. The catheter device of claim 8, wherein: The adjustment housing forms an anchor holder, which is connected to the nipple anchor when it is stowed and during deployment; wherein the anchor holder releases the nipple anchor after the nipple anchor is successfully deployed; the anchor holder is arranged in at least two parts, the at least two parts are interlocked, and relative rotation between the two parts is prevented by the corresponding non-circular shape.

16. The catheter device of claim 15, wherein: The two parts of the anchor holder include a piston for engaging with the nipple anchor and a piston housing for retaining the piston, the piston being actuatable for sliding movement relative to the piston housing.

17. The catheter device of claim 16, wherein: The piston includes a cutter for cutting the wire once the nipple anchor has been successfully deployed in the desired position, wherein the wire is adjusted to the appropriate length.

18. The catheter device of claim 17, wherein: The cutter and / or the piston holder include one or more stops that act as stop features to prevent the cutter from moving beyond an upper position and / or a lower position within the device.

19. The catheter device of claim 16, wherein: The piston comprises a piston wedge for engaging with an elastically deformable locking section of the nipple anchor, the piston wedge being arranged to be pushed between the locking section and a wall of the nipple anchor to elastically deform the locking section.

20. The catheter device of claim 19, wherein: The piston wedge includes a tapered shape at a distal end to facilitate engagement and disengagement with the locking segment.

21. The catheter device of claim 19, wherein: The anchor retainer and the nipple anchor are arranged such that when the piston wedge is engaged with the locking segment, the piston wedge is spaced apart from a wall of the nipple anchor.

22. The catheter device of claim 19, wherein: An inner cam is configured as part of the anchor retainer to help maintain the anchor locking segment in an open position; and wherein the inner cam has an unexpanded configuration and an expanded configuration, wherein the cam fits inside the locking segment in an undeformed state of the locking segment and the cam fits inside the locking segment in the deformed state.

23. The catheter device of claim 22, wherein: The cam has an opening at its center which is wider in the expanded configuration than in the unexpanded configuration, and the piston is provided with a cam wedge for pushing the opening of the cam to a wider state and thereby expanding the cam.

24. The catheter device of claim 23, wherein: The piston has a forked form at its distal end, at least one tine of the fork providing the cam wedge and at least one tine of the fork providing the piston wedge.

25. The catheter device of claim 8, comprising a mechanism for controlling movement of the adjustment housing relative to the distal portion, the mechanism comprising an adjustment catheter located within the housing of the catheter device, wherein: The adjustment conduit may be moved forward or backward along the length of the conduit device to advance or retract the adjustment housing.

26. The catheter device of claim 8, wherein: The adjustment housing includes a latch for engaging with a housing section of the catheter device to prevent movement of the adjustment housing relative to the catheter device.

27. The catheter device of claim 26, wherein: The latch may be pivotable about an axis extending along the longitudinal axis of the catheter device to allow it to be swung into and out of engagement with the housing segments and includes a wire or rod therein for actuating the latch.

28. The catheter device of claim 27, wherein: The wire or rod blocks movement of the latch to maintain a secured condition until the wire or rod is removed, at which time the latch is free to move to a position where it is disengaged from the housing segments.

29. A catheter device according to claim 27 or 28, wherein The latch is sprung and biased toward a disengaged position such that when the latch is released, the latch moves to the disengaged position under the action of a spring force.

30. The catheter device of claim 1, wherein: The outer shape of the distal portion is a shape different from the non-circular shape such that the thickness of the wall of the distal portion varies; And wherein the thicker section of the wall of the distal portion includes a cable channel.

31. The catheter device of claim 1, wherein: The housing segment is formed from one or more tubular segments made from stainless steel, Nitinol, a polymeric material, or a composite material.

32. The catheter device of claim 7, wherein: The distal end of the anchor deployment mechanism and / or the distal portion is funnel-shaped.

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