Soft Tissue Anchor System for Cardiac Repair

Abstract

Disclosed herein are various soft tissue anchor systems for cardiac repair, catheter devices for implanting the soft tissue anchor systems in cardiac tissue, methods for implanting the soft tissue anchor systems in soft body tissue, and methods for manufacturing the soft tissue anchor systems. A soft tissue anchor system (200) for implantation in soft body tissue (12) to hold an artificial line (214) comprises a U-shaped woven body (201) having a base portion (202) and at least two arms (204) extending from the base portion (202), each arm portion (204) configured to fold towards the base portion (202) such that, in use, the body tissue (12) is sandwiched between the base portion (202) and each arm portion (204).

Description

[Technical field]

[0001] The present invention relates to a soft tissue anchor system for implantation into soft body tissue to retain a line. [Background technology]

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

[0003] Mitral valve disease presents a significant challenge to cardiac surgeons and cardiologists. Mitral regurgitation has become the major pathophysiological condition of the mitral valve in developed countries. One of the most important causes of regurgitation is the prolapse of one of the mitral valve leaflets. The pathological abnormality requiring repair is rupture or other degenerative changes of the chordae, leaflets or other associated structures. If the chordae remain intact, the mitral valve leaflets open and close synchronously to prevent valve leakage. Normal chordae can rupture suddenly, causing acute decompensation in the form of heart failure. This usually results in an emergency condition requiring prompt intervention. Damage to the chordae can also occur more slowly, including rupture or elongation due to degenerative processes, causing the mitral valve to leak or regurgitate.

[0004] Surgical repair of the mitral valve has become relatively standardized, using resection of the prolapsed leaflets and / or implantation of new artificial chordal lines to control leaflet movement. In addition, mitral rings are frequently placed to reduce the size of the mitral annulus. Surgical replacement of ruptured or elongated chordal is highly effective in eliminating or minimizing mitral regurgitation. This procedure is currently performed using open-heart surgery techniques. This requires the use of cardiopulmonary bypass and arrest of the heart. Although this surgical approach works well, it is a highly invasive procedure that can cause serious complications, prolonged hospital stays, and substantial costs. Thus, a less invasive approach would be preferable. Similarly, a less invasive approach would be preferable for the treatment of the tricuspid valve, which can suffer from tricuspid valve disease, just like the mitral valve.

[0005] Insertion of the chordae for the mitral valve leaflets has been performed using a minimally invasive surgical technique that enters the heart through the apex. This technique has been developed by Neochord and is described, for example, in WO 2012 / 167120, but still requires a surgical incision and the chordae are not inserted into the papillary muscles where they would normally be fixed.

[0006] WO 2008 / 101113 describes another example of a system for cardiac repair, including the implantation of an artificial chordae line. In the described method, an anchor can be attached to the papillary muscle and is connected to the leaflets of the mitral valve by an artificial chordae line, sutures and clips. The clips allow for adjustment of the length of the artificial chordae line. A complex multi-step process is required to implant the papillary anchor and sutures and to join them to each other. The papillary anchor is formed from a shape memory alloy, such as Nitinol, and has a "blooming" shape with sharp "petals" to hook the anchor to body tissue. This blooming shape is flattened into a tube and held in a tube that is threaded into 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 petals pierce the muscle and fold outwards through the muscle, securely attaching the anchor to the muscle tissue. In a subsequent surgical procedure, an artificial chordae line can be attached to the anchor. Then, in a further step, a suture is attached to the leaflet, which is joined to the chordae by a clip. The suture is attached to the leaflet by placing a vacuum port near the leaflet and drawing it into the vacuum port, where it can be punctured.

[0007] It will be appreciated that although this technique avoids open heart surgery, it still requires a relatively complicated sequence of steps. The number of steps required increases the risks. Furthermore, the complexity of the device means that there is a risk that the parts implanted in the body may come loose and injure the patient by emboli. In particular, the clips may come loose from their anchors. It is also believed that the use of sutures with additional clips, as proposed, may not effectively repair the heart valve, as they do not closely simulate the natural chordae.

[0008] In a prior patent application, WO 2016 / 042022, the applicant disclosed a catheter device for implanting an artificial chordae line to repair a heart valve. The catheter device of WO 2016 / 042022 includes a mechanical gripper device for gripping a leaflet of a heart valve with a leaflet anchor housed within the gripper. The leaflet anchor can be formed, for example, from a flexible material, such as Nitinol, that has a grapple hook shape in a deployed configuration and can be elastically deformed to a folded configuration when restrained within a leaflet anchor channel in the gripper device. The hooks straighten when the leaflet anchor is in the folded configuration. Once the leaflet is gripped by the gripper device, the leaflet anchor can be pushed out of the gripper to drive the hooks through the leaflet while they elastically return to the deployed configuration, thereby securing the leaflet anchor within the leaflet.

[0009] The device described in WO 2016 / 042022 also uses a nipple anchor with a similar configuration of foldable hooks. The nipple anchor is held in a tube of the catheter device in a folded configuration and can be pushed out of the tube by the hooks being pushed into the heart wall while they elastically return to the deployed configuration, thereby securing the nipple anchor to the muscle. The nipple anchor includes a locking ring that acts as a locking mechanism for fastening the artificial chord line when no force is applied. The locking ring can be elastically deformed to adjust the length of the chord line to release the line from the locking mechanism.

[0010] In another prior patent application, WO 2020 / 109588, the applicant disclosed further improvements to the catheter device disclosed in WO 2016 / 042022 and new developments related thereto. One area of ​​improvement focuses on the design of the leaflet anchor. The leaflet anchor disclosed therein was designed to increase the surface area of ​​the leaflet anchor that contacts the leaflet upon implantation and to minimize the trauma suffered by the leaflet during implantation.

[0011] Other anchoring systems are also known, for example from U.S. Patent Application Publication No. 2009 / 0076547, which discloses a tissue anchor including a single elongated strip having a folded portion. The elongated strip is delivered from a tubular member that passes through the tissue. A suture is extended through the elongated strip and looped back. When tension is applied by the suture, the elongated strip folds around the tissue.

[0012] Although the devices of WO 2016 / 042022 and WO 2020 / 109588 have provided significant advances in the field, it has been found that further improvements in design may be advantageous. The present disclosure relates to new features that build upon the designs of the devices disclosed in WO 2016 / 042022 and WO 2020 / 109588 in various aspects. Summary of the Invention

[0013] It is an object of the present invention to provide an improved anchor system for implantation in soft body tissue, and more preferably cardiac tissue.

[0014] According to the present invention there is provided herein a soft tissue anchor system as described in the second aspect, a catheter device as described in the fourth and fifth aspects, a method of implanting a soft tissue anchor system according to an eighth aspect into body tissue, and a method of manufacturing a soft tissue anchor system according to a ninth aspect.

[0015] According to a first aspect of the present invention there is provided a soft tissue anchor system for implantation into soft body tissue to secure an artificial line, comprising a line and a tubular cap member, an end of the line being secured to the tubular cap member and extending from a central portion thereof such that, in use, the tubular cap member, when implanted in the soft body tissue, extends in a plane parallel to a surface of the soft body tissue and is configured to extend under tension of the line as it passes through the tissue in an outward direction from that surface, the tubular cap member comprising an opening configured to receive a wire guide member for passing the tubular cap member through the soft body tissue during implantation.

[0016] By providing the tubular cap member with an opening configured to receive a wire guide member for passing the tubular cap member through the soft body tissue during implantation, the tubular cap member can be manipulated so that it can pass through the soft body tissue in a narrow configuration. For example, the wire guide member can push the tubular cap member in an insertion direction so that the tubular cap member passes through the soft body tissue in the narrow configuration. In other words, the opening can facilitate engagement between the wire guide member and the tubular cap member, such that the tubular cap member can be held end-forward and then passed through the soft body tissue in a direction parallel to its axis. Passing the tubular cap member through the soft body tissue in this manner can minimize trauma at the implantation site of the soft tissue anchor system.

[0017] Moreover, by driving the tubular cap member through the body tissue using a wire guide member, rather than a needle or delivery catheter passing through the body tissue from which the soft tissue anchors are deployed, the bore in the body tissue through which the tubular cap member passes does not need to be as large as the bore required for the needle or other conduit that houses the soft tissue anchor system to pass through. That is, the size of the implantation site in the body tissue (i.e., the opening formed during implantation) is constrained only by the geometry of the tubular cap member, or other portion of the soft tissue anchor system, passing through the soft body tissue. In comparison, the size of the opening required for implantation through a needle is always constrained by the size of the needle, which is always larger than the member being deployed. This can reduce trauma to the implantation site.

[0018] Once the tubular cap member has passed through the soft body tissue, the wire guide member can be withdrawn. Then, in use, tension is again applied through the line passing through the soft body tissue from the point where the tubular cap member passed through the soft body tissue, pulling the tubular cap member against the soft body tissue so that it extends in a plane parallel to the soft body tissue. The line may then extend through the soft body tissue, with the tubular cap member contacting the soft body tissue over a maximum surface area, preventing the tubular cap member from being withdrawn back through the implantation site.

[0019] Thus, the soft tissue anchor system of this aspect can be implanted into soft body tissue such that during implantation, the resulting contact force between the tubular cap member and the soft body tissue secures the artificial cord line to the soft body tissue in a manner that minimizes the size of the implantation site and, therefore, the resulting trauma.

[0020] Thus, when the wire guide member engages the tubular cap member, a configuration is provided in which the tubular cap member is straight and extends in line. This allows the tubular cap member to be easily embedded in soft body tissue. Then, when the line is subjected to a force, the line can rotate the tubular cap member to be parallel to the surface of the body tissue for central fixation with the tubular cap member. This can facilitate fixation of the tubular cap member to the soft body tissue because under tension, the tubular cap member can be rotated perpendicular to the line in a "T" configuration, with the line perpendicular to the surface of the body tissue and the length of the tubular cap member parallel to the surface of the body tissue, preventing movement of the tubular cap member through the soft body tissue (similar to how a treasury tag remains fixed when in use).

[0021] The tubular cap member, in combination with the lines, can be thought of as a "T-bar" anchor given its deployed "T" configuration.

[0022] The tubular cap member may be an elongate tubular body with a hollow for receiving the wire guide member. The opening / hollow may extend completely along the entire length of the tubular cap member or may alternatively include a blind hole opening / hollow.

[0023] The tubular cap member can include a first end, a second end distal to the first end, and a sidewall extending between the first and second ends. The opening can be disposed in the first end of the tubular cap member. The second end of the tubular cap member can define a tip of the tubular cap member, the tip being configured to be inserted into soft body tissue.

[0024] The central portion of the tubular cap member may be considered to be the portion of the tubular cap member located about the geometric center of the tubular cap member (i.e., the center point along the longitudinal axis of the tubular cap member), which portion includes less than 30% of the length of the tubular cap member, less than 40% of the length of the tubular cap member, less than 50% of the length of the tubular cap member, or less than 60% of the length of the tubular cap member. The central portion of the tubular cap member may be considered to include the "middle third" of the length of the tubular cap member. In other words, the central portion of the tubular cap member may include any point on the tubular cap member that is closer to the geometric center of the tubular cap member than either the first end or the second end.

[0025] The tubular cap member may be formed from a suitably rigid biocompatible material capable of retaining its shape, such as stainless steel, titanium, engineering plastics or Nitinol.

[0026] The lines may be considered tension lines because, in use, when embedded, they apply tension to the tubular cap member.

[0027] The line may be formed from a suture material. The line may be an artificial line. Alternatively, the line may be secured to the artificial line by any suitable fastening arrangement, such as a knot or a looped engagement.

[0028] As discussed above, the ends of the lines are secured to the tubular cap member with the lines extending from a central portion of the tubular cap member. The location of the points from which the lines extend from the tubular cap member along the central portion of the tubular cap member provides a stable configuration for maintaining the "T" configuration during implantation.

[0029] In some examples, the line may be substantially central, ie, extend substantially centrally from the center of the tubular cap member (eg, coincident with the geometric center of the tubular cap member).

[0030] In other examples, the line may extend asymmetrically and thus extend from a point along the tubular cap member more toward the first end or the second end of the tubular cap member (but still within a central portion of the tubular cap member).

[0031] For example, an asymmetrical arrangement can position a point from which the line extends from the tubular cap member distal to the opening (i.e., toward the tip of the tubular cap member). Having the line extend from a point located toward the tip of the tubular cap member can facilitate torqueing the tubular cap member into a "T" configuration. However, in other preferred examples, the point from which the line extends from the tubular cap member can be proximal to the opening of the tubular cap member (i.e., closer to the opening of the tubular cap member than the tip). Having the line extend from a point located toward the opening of the tubular cap member can better distribute the contact force exerted by the tubular cap member when implanted and extending in a plane parallel to the surface of the body tissue under tension of the line. The end cap can have a smaller projected area closer to its tip (e.g., due to a taper and / or bevel at the tip) and the tubular cap member can have a larger projected area closer to the opening (e.g., due to tapering / widening of the tubular cap member toward the opening). Thus, locating the point at which the line extends from the tubular cap member proximal to the opening can result in a more balanced distribution of the contact forces exerted by the profile of the tubular cap member as it extends in a plane parallel to the surface of the body tissue.

[0032] Thus, the line can extend from a central portion of the tubular cap member to which it is secured, substantially to the center of the tubular cap member, as described above, toward the first end of the tubular cap member, or toward the second end of the tubular cap member.

[0033] The manner in which the end of the line is secured to the tubular cap portion can cover the length of the tubular cap member. For example, a length of the end of the line may be wrapped circumferentially around the tubular cap member or a portion thereof, and this length of the line additionally extends along the axial length of the tubular cap member (i.e., in a spiral or coil). The line extending from the tubular cap member may extend from this coiled portion of the line. Alternatively, the length of the end of the line or a portion thereof secured to the tubular cap member may extend substantially axially along the tubular cap member or a portion thereof. The line extending from the tubular cap member may extend from this length of the line.

[0034] The end of the line may be secured to a central portion of the tubular cap member. However, the end of the line need not be limited to being secured to a central portion of the tubular cap member, so long as the line extends from the central portion of the tubular cap member. Thus, in another phrase, the soft tissue anchor system may be thought of as having an end of the line secured to a central portion of the tubular cap member, and this particular description of the end of the line refers to the portion of the line that first extends from the tubular cap member (i.e., is the "end" portion of the line that determines the location along the tubular cap member where tension can be applied to the tubular cap member by the line in use).

[0035] The wire guide member received by the opening is adapted to pass the tubular cap member through soft body tissue during implantation. In other words, the wire guide member is adapted to fix the soft tissue anchor system in the body tissue by passing the tubular cap member through the soft body tissue during implantation. As a result of the tubular cap member passing through the soft body tissue, the soft tissue anchor system is embedded in the body tissue and the artificial line is fixed.

[0036] The tubular cap member may be a unitary component (e.g., a hollow tube) and the lines are tied or otherwise secured to the tubular cap member. The tubular cap member may be formed as a unitary component by laser cutting or machining Nitinol or stainless steel.

[0037] Alternatively, the tubular cap member may comprise an outer tubular member and an inner tubular member, the outer tubular member configured to receive the inner tubular member. That is, the inner tubular member may be nested within and / or concentric with the outer tubular member. The inner tubular member may define an opening configured to receive the wire guide member.

[0038] The inner tubular member may include a flared inlet defining an opening configured to receive the wire guide member. The flared inlet is understood to be a portion of the inner tubular member that defines the opening, where the circumferential extent of the inner tubular member increases relative to the remainder of the inner tubular member.

[0039] Preferably, the flared entrance includes an angled surface to facilitate guiding the wire guide member into the inner tubular member, which may be preferred when the wire guide member is not received by the opening in the tubular cap member prior to implantation.

[0040] The flared inlet may be configured to mate with a corresponding portion of the wire guide member. That is, the flared inlet may be complementary to the shape of, for example, a shoulder region or a bulge of the wire guide member. The sloping surface of the flared inlet may be complementary to, for example, a shoulder region or a bulge of the wire guide member. The flared inlet may improve contact between the wire guide member and the tubular cap member during embedding of the fabric body.

[0041] The inner tubular member may be retained within the outer tubular member via a press fit and / or mating notches. The inner tubular cap member may also, or alternatively, be retained within the outer tubular member via a crimping action.

[0042] The flared inlet may be configured to position the inner tubular member within the outer tubular member. An end of the inner tubular member proximal to the opening may mate with the outer tubular member via a mating notch, a press fit, and / or a crimp connection. The flared inlet may provide a press fit between the inner tubular member and the outer tubular member. An end of the inner tubular member distal to the opening may also mate with the outer tubular member via a mating notch, a press fit, and / or a crimp connection. Providing at least two retention areas or points may improve retention strength of the inner tubular member within the outer tubular member.

[0043] The outer tubular member can include a shoulder region distal to the opening configured to mate with the inner tubular member, which can facilitate positioning of the inner tubular member within the outer tubular member such that the opening defined by the inner tubular member is properly positioned over the end of the tubular cap member.

[0044] The tubular cap member can be configured to receive a line between the inner and outer tubular members. The line may be secured to the tubular cap member by crimping, swaging, clamping, gluing and / or sandwiching the line between the inner and outer tubular members. The line can also be secured by suturing it or tying it to the tubular members.

[0045] The outer tubular member may include a sidewall and an opening (i.e., aperture) formed in the sidewall, the opening receiving the line. An end of the line may be secured to the tubular cap member between the outer tubular member and the inner tubular member. The aperture may be formed in a central region of the outer tubular member, thereby facilitating extension of the line from, and optionally securing of, the end of the line to, the central portion of the tubular cap member.

[0046] The outer tubular member may include a groove extending from the opening toward the opening. The groove may be configured to receive the line during implantation. Thus, the profile of the line during implantation may be embedded in the tubular cap member and thereby at least partially contained within the profile of the tubular cap member, thereby minimizing the size of the implantation site and further reducing trauma during implantation.

[0047] The tubular cap member can include a tip configured to pierce body tissue, the tip being disposed at an end of the tubular cap member distal to the opening configured to receive the wire guide member, and the tip may be configured to pierce body tissue when a driving force is applied to the tubular cap member by the wire guide member.

[0048] The tip may include a conical tip, i.e. a tip having rotational symmetry about the longitudinal axis of the tubular cap member.

[0049] Alternatively, the tip may have a rotationally asymmetric shape about the longitudinal axis of the tubular cap member. The use of a rotationally asymmetric tip shape for the tip can facilitate the tip having a higher draft angle relative to the plane of its point (i.e., the plane of its shear edge). The use of a tip with a higher draft angle can reduce the force required for the tip to pierce soft body tissue and therefore the trauma experienced at the implantation site during implantation.

[0050] To this end, the tip may include a beveled surface, which is understood to define a single plane, i.e., a plane where the surface of the bevel is ground (e.g., a ground surface) or formed in any other manner.

[0051] The bevel surface can define a surface of a pointed end. The bevel surface can have a draft of greater than 50°, greater than 60°, greater than 70°, or greater than 80° relative to a radial surface of the tubular cap member. The bevel surface can have a draft of less than 10°, less than 20°, less than 30°, or less than 40° relative to a longitudinal axis of the tubular cap member.

[0052] The point may include a single beveled surface and may be described as a beveled tip or a chisel tip.

[0053] Alternatively, the tip may include two lancet faces in addition to the bevel face. The lancet face may be adjacent to the bevel face, preferably symmetrically. Each of the bevel face and the lancet face is understood to define a respective surface (such as a ground surface). Such a tip shape may be described as a lancet point tip. Thus, the tip may be a lancet tip.

[0054] In configurations where the opening configured to receive the wire guide member includes a blind hole or blind hole hollow, the tip can be considered a pointed stylet, and in configurations where the opening configured to receive the wire guide member extends completely through the tubular cap member (such a configuration simplifies manufacture of the tubular cap member), the tip can be considered a pointed cannula.

[0055] The tip may be a retractable tip. The tip of the tubular cap member may have a first position in which the tip is a tip, i.e. the tip is deployed, and a second position in which the tip is a blunt and / or rounded tip, i.e. the tip is retracted. The second position may be a rest position of the retractable tip. The retractable tip may be biased from the second position to the first position via engagement of the wire guide member and the tubular cap member.

[0056] The outer tubular member can define a tip. If the tip is permanently present, the inner tubular member can include a blind hole that receives the wire guide member. If the tip is a retractable tip, the inner tubular member can be hollow such that the wire guide member can actuate the retractable tip and / or any suitable deployment mechanism.

[0057] Alternatively, the tubular cap member may include a blunt and / or rounded tip, the blunt and / or rounded tip located at an end of the tubular cap member distal from the opening configured to receive the wire guide member.

[0058] Having a blunt and / or rounded tip reduces the risk of laceration and / or further trauma to body tissue caused by the tubular cap member upon implantation or otherwise.

[0059] The outer tubular member and the inner tubular member each define an opening extending along their entire length, i.e., they are hollow along their entire length. The inner tubular member may be configured to pass a piercing section of the wire guide member and may be configured to abut a shoulder or bulge of the wire guide member. A wire guide member including a piercing section configured to pierce body tissue during implantation of the anchoring system may be considered a piercing wire guide member.

[0060] By allowing the penetrating wire guide member to pass through the inner tubular member, the tubular cap member can include a blunt and / or rounded tip while still allowing for puncture of body tissue during implantation of the anchoring system. Additionally, by providing the inner tubular member configured to abut a shoulder or bulge on the wire guide member, adequate contact for manipulation of the arms through the penetrating wire guide member can be achieved.

[0061] Moreover, the use of a tubular cap member suitable for use with a puncture wire guide member can further reduce trauma to the implantation site because the puncture section of the wire guide member can have a smaller diameter than, for example, the hollow needle member that makes the incision for implantation.

[0062] The inner tubular member may extend from the outer tubular member and may define a distal end of the tubular cap member. This configuration provides a gradual transition between the inner and outer tubular members at the distal end of the tubular cap member, which may facilitate smoother passage of the tubular cap member through body tissue during implantation.

[0063] Alternatively, the outer tubular member may include a tapered portion located at the distal end of the tubular cap member, i.e., the distal end of the tubular cap member may be defined by the outer tubular member, and the end of the inner tubular member may be housed within the outer tubular member. This configuration provides a continuous transition between the distal end of the tubular cap member and the outer tubular member located at the distal end of the tubular cap member, which may facilitate smoother passage of the tubular cap member through body tissue during implantation.

[0064] The soft tissue anchor system can include a woven body having a base portion and arm portions extending from the base portion, the arm portions configured to fold toward the base portion in use such that body tissue is sandwiched between the base portion and the arm portions, and a tubular cap member secured to ends of the arm portions distal to the base portion.

[0065] In other words, viewed from another aspect of the invention there is provided a soft tissue anchor system for implantation in soft body tissue for anchoring an artificial line, comprising a fabric body having a base portion and arms extending from the base portion, the arms being configured to be folded towards the base portion such that in use body tissue is sandwiched between the base portion and the arms, the arms comprising a tubular cap member secured to ends of the arms distal to the base portion, an end of the line being secured to the tubular cap member and extending from a central portion thereof such that in use the tubular cap member extends in a plane parallel to a surface of the soft body tissue when implanted in the soft body tissue and is configured to extend under tension of the line as it passes through the tissue in a direction outward from that surface, the tubular cap member being configured to receive a wire guide member for implanting the anchor in the body tissue and to pull the arms through the body tissue during implantation.

[0066] By providing a fabric body in combination with a tubular cap member, the anchoring system may be able to contact a larger surface area of ​​body tissue when implanted and therefore may have improved stability and / or improved tissue ingrowth upon implantation. Additionally, by providing foldable arm portions attached via the base portion, it may further be possible for the base portion itself to provide a larger surface area for connecting the anchoring system with soft body tissue upon implantation.

[0067] Additionally, the use of a fabric body as compared to a rigid body such as a metal body can reduce damage to body tissue caused by the anchor during and / or after implantation. The fabric can better complement the surface of the body tissue it contacts, thus distributing the forces exerted on the body tissue over a larger area and reducing the trauma experienced by the body tissue at the implantation site.

[0068] The folding of the arms towards the base can be considered as a bellows motion, and therefore the arms may also be configured to bellow towards the base such that in use, body tissue is sandwiched between the base and the arms.

[0069] A fabric body formed from a fabric material may be naturally arranged to fold and / or bellow due to the conformable nature of the fabric, however, in some configurations, the arms may include fold lines, constrictions, and / or weakened portions configured to assist in the folding and / or bellows movement of the arms.

[0070] It will be appreciated that the tubular cap member is secured to the ends of the arms distal to the base portion such that the arms are configured to be pulled through the soft body tissue as the tubular cap member passes through the soft body tissue during implantation.

[0071] The tubular cap member may be considered an "end cap," for example, with respect to how the tubular cap member may form the capped end of the arm portion.

[0072] The arm portion can be secured toward and / or to the opening in the tubular cap member, i.e., at the end of the tubular cap member distal to the tip of the tubular cap member (i.e., the end of the tubular cap member in the direction of insertion during implantation).

[0073] The outer tubular member and the inner tubular member may be configured to sandwich, crimp, and / or clamp the distal ends of the respective arms therebetween to secure the tubular cap member to the arms. An adhesive may additionally or alternatively be used to secure the tubular cap member to the arms.

[0074] The outer tubular member may include a groove, channel, opening, or other suitable feature for guiding the arms between the outer tubular member and the inner tubular member. The groove, channel, opening, or other suitable feature may be formed in circumferential alignment with the opening in the line, and may also be formed at or toward the opening configured to receive the wire guide member. Providing the line and arms in alignment with one another may improve stability of the soft tissue anchor system when implanted in soft body tissue.

[0075] By fixing the arms towards the opening of the tubular cap member and fixing the line to a central portion of the tubular cap member, it can be easier to apply a torque to the tubular cap member when the line is under tension, thereby allowing the tubular cap member to lie flat against the soft body tissue during implantation.

[0076] Securing the arms towards and / or at the opening of the tubular cap member can also facilitate retrieval of the tubular cap member. For example, tension on the line can be relieved as the tubular cap member is retrieved. The arms / fabric body can then be pulled to apply tension. As a result of this tension, a torque can be applied to the tubular cap member, causing it to rotate so that it extends in a plane perpendicular to the surface of the soft body tissue (e.g., so that it extends collinearly with the line). The tubular cap member can then be pulled and / or guided back through the soft body tissue. This configuration can thus facilitate retrieval of the tubular cap member in a manner that also minimizes any trauma to the body tissue during retrieval.

[0077] Alternatively, an opening formed in a sidewall of the outer tubular member that receives the line may receive the arm, and thus, securing of the arm and line to the tubular cap member may be simultaneous.

[0078] Alternatively, the outer tubular member may not include a flared entrance defining a channel for guiding the arms between the outer and inner tubular members and / or an opening configured to receive the wire guide member, as may be preferred in configurations where the wire guide member is received by the opening in the end cap prior to implantation. As a result, the tubular cap member may be made shorter and / or thinner (i.e., narrower in diameter) and therefore more compact for configurations where the wire guide member does not need to be guided into engagement with the tubular cap member during implantation.

[0079] The fabric body may be formed from a single layer of fabric or multiple layers of fabric. In this context, a fabric may be considered a material formed as a woven fabric made from threads or thread-like forms. One possible material is polyester fabric, other materials include fabrics of PET, UHMPE, EPTFE, PTFE, etc. The fabric body may be formed from any suitable flexible, conformable and biocompatible material. The fabric body may be formed by laser cutting existing materials or any other suitable manufacturing technique.

[0080] When the line is secured to the artificial line, it is secured to the artificial line behind the base, i.e. distal to the tubular cap member, and not between the tubular cap member and the base. In other words, the line may have a first end joined to the tubular cap member and a second end extending from the base, having a length at least greater than the length of the fabric body. This second end, located past the base, can then be secured to the artificial line.

[0081] The arm portion may be configured to fold towards the base portion by action of a line threaded through the arm portion and the base portion, and thus the line may be configured to cause the arm portion to fold towards the base portion when tension is applied to the line.

[0082] When tension is applied to the line, the entire arm portion may collapse under tension in the line toward the base portion because the line is secured to the tubular cap member and threaded through the arm portion.

[0083] The location through which the line is routed can facilitate the folding of the arms. For example, when the line is pulled, it can pull into holes in the arms through which the tension line is routed. Thus, the arms can be biased to collapse for each location through which the tension line is routed.

[0084] Preferably, the anchoring system is configured such that tension is applied to the portion of the line that is threaded through the base portion, which can facilitate folding of the entire arm portion.

[0085] The line may be threaded through the arm and base portions only three or four times. This configuration may facilitate the holes in the fabric body through which the line is threaded being spaced further apart and / or a shorter fabric body being utilized. Relative to the size of the anchor, each of these configurations may provide a wider folded portion of the fabric body that improves the stability of the anchor system upon implantation. Using a shorter fabric body may also reduce the overall size of the soft tissue anchor system, thus improving its packaging within a delivery device / system for implantation.

[0086] Additionally or alternatively, the arms may be configured to fold toward the base due to the presence of a backbone formed from a resilient material. The resilient material may be a shape memory metal such as Nitinol. The backbone may be in contact with at least each arm and may also be in contact with the base. The backbone may be embedded in or interwoven with the fabric body and / or sandwiched between layers of the fabric body.

[0087] The backbone can include a folded configuration and an unfolded configuration. The backbone can be held in the unfolded configuration by application of a restraining force. In the unfolded configuration, the arms can extend outwardly from the base. Upon removal of the restraining force, the backbone can return to a folded portion in which the backbone includes one or more folds. The arms occupy the same shape as the backbone due to the contact between them. Thus, the backbone can be a resiliently biased backbone configured to bias the arms towards the base to fold.

[0088] If a backbone is utilized, the lines may be threaded only through the arms or may extend adjacent to the creases formed in the arms when they are folded.

[0089] As discussed above, (i) the configuration in which the line is threaded through the arm portion, and (ii) the configuration in which the base portion and backbone are formed from an elastic material, can each be considered as different means for folding the arm portion toward the base portion.

[0090] In other words, viewed from another aspect of the invention there is provided a soft tissue anchor system for implantation in soft body tissue for anchoring an artificial line, comprising a fabric body having a base portion and arms extending from the base portion, and means for folding the arms towards the base portion such that in use body tissue is sandwiched between the base portion and the arms, the arms comprising a tubular cap member secured to ends of the arms distal to the base portion, an end of the line being secured to the tubular cap member and extending from a central portion thereof such that, in use, the tubular cap member extends in a plane parallel to a surface of the soft body tissue when implanted in the soft body tissue and is configured to extend under tension of the line as it passes through the tissue in a direction outward from that surface, the tubular cap member being configured to receive a wire guide member for implanting the anchor in the body tissue and to draw the arms through the body tissue during implantation.

[0091] In alternative terms, the means for folding the arm portion towards the base portion may be considered equally as a mechanism for folding the arm portion towards the base portion, and / or a folding mechanism configured to fold the arm portion towards the base portion, including at least one of: (i) a configuration in which a line is threaded through the arm portion; and (ii) a configuration in which the base portion and the backbone are formed from an elastic material, without departing from the above aspects.

[0092] The tubular cap member may be configured to extend collinearly with the arms during implantation and / or retrieval of the fabric body. The tubular cap member may also be configured to extend parallel to the plane of each fold of the arms when tension is applied to the line.

[0093] As discussed above, the arms may be secured to an end of the tubular cap member proximal to the arms (e.g., the end where the opening is located) and the lines extend from a central region of the tubular cap member. Thus, tension exerted by the arms and / or lines during implantation may apply a torque to the tubular cap member to facilitate transition of the tubular cap member from a configuration in which it extends collinearly with the arms to a configuration in which it extends in a plane parallel to the folds of the arms and / or the surface of the soft body tissue.

[0094] Thus, when the wire guide member engages the tubular cap member, the tubular cap member straightens and extends in a line with the arms. This allows the arms of the fabric body to be easily embedded in the body tissue. When the line is under tension, thus folding the arms, the tension can rotate the tubular cap member to be parallel to the fold of the arms and therefore parallel to the surface of the body tissue on which the arms are folded. This can facilitate the fixation of the arms to the body tissue and can also minimize the profile of the tubular cap member protruding from the body tissue during embedding. For example, the tubular cap member can be rotated perpendicular to the tension line in the aforementioned "T" configuration, such that the line is perpendicular to the surface of the body tissue and the length of the tubular cap member parallel to the surface of the body tissue, preventing the movement of the tubular cap member through the body tissue. When the fabric body portion is retrieved from the body tissue, for example by being pulled from the distal direction of the tubular cap member, the tension acting through the arms can self-correct the tubular cap member from a parallel position to extend in a line with the arms during retrieval. Thus, by connecting the arms at their ends to the tubular cap member, tension from the arms tends to straighten the tubular cap member (e.g., from the "T" configuration described above), thereby allowing the tubular cap member to align with the arms and thus with the holes through the body tissue. This can facilitate retrieval and minimize any trauma to the body tissue during retrieval.

[0095] The fabric body may optionally include a reinforcing member defining a plurality of holes through which the tension lines are threaded. The reinforcing member may be implemented, for example, as a tension member that provides additional tensile strength to the fabric body. The reinforcing member may be considered the backbone of the fabric body and may preferably include a shape complementary to the fabric body. The tension lines may preferably be threaded through the reinforcing member in addition to the fabric body. The reinforcing member may define holes through which the tension lines are threaded.

[0096] The reinforcing member may be embedded in the fabric body. The reinforcing member may be interwoven with the fabric body. The reinforcing member may be sandwiched between layers of the fabric body.

[0097] The reinforcing member may be at least one high tensile strength line woven into the fabric to take excessive tensile loads that may be applied to the fabric during embedding, retraction, or along its life cycle.

[0098] The reinforcing members can strengthen the fabric body and provide additional support at the points where the tension lines are passed through the fabric body, as well as optionally where the tubular cap members are attached, and at any points along the length of the fabric where the fabric narrows, thus improving the structural integrity of the fabric body.

[0099] The fabric body may be a U-shaped fabric body having a base portion and at least two arms extending from the base portion, each arm portion having a tubular cap member secured to an end of the arm portion distal to the base portion.

[0100] In other words, viewed from another aspect, there is provided a soft tissue anchor system for implantation into soft body tissue to hold an artificial line, the soft tissue anchor system comprising: a line; a U-shaped fabric body having a base portion and at least two arms extending from the base portion, each arm portion configured to be folded towards the base portion in use such that body tissue is sandwiched between the base portion and each arm portion; and a tubular cap member secured to an end of each arm portion distal to the base portion, the end of the line being secured to each tubular cap member and extending from a central portion thereof such that, in use, each tubular cap member extends in a plane parallel to a surface of the soft body tissue when implanted in the soft body tissue and is configured to extend under tension of the line as the line passes through the tissue in a direction outward from that surface, the tubular cap member comprising an opening configured to engage a wire guide member for implanting the U-shaped fabric body into the body tissue.

[0101] By providing a fabric body including at least two arms extending from the same base, the anchoring system may be able to contact a larger surface area of ​​body tissue when implanted and therefore may have improved stability and / or improved tissue ingrowth when implanted. Furthermore, by providing foldable arms attached via the base, the base itself may further be able to provide a larger surface area for connecting the anchoring system with the leaflets when implanted. A U-shaped anchoring system, i.e., a U-shaped anchoring system with at least two arm options, may provide improved performance compared to a single arm.

[0102] Thus, soft tissue anchor systems as described above may have improved fixation strength compared to known anchor systems that include a single arm and / or fixation member and / or use different design features.

[0103] In the examples herein using at least two arms, the U-shaped body is said to result from the U-shape formed by the base and the two arms. However, it is understood that this simply refers to the unit structure of the fabric body having two arms, and the shape will be different when more arms are present. For example, a fabric body including three arms can be considered as a W-shaped body, and the W-shaped body includes two U-shaped units. Thus, the anchoring system may include a fabric body including multiple U-shaped units so that a fabric body of an appropriate size can be achieved for the desired purpose of the soft tissue anchoring system.

[0104] The base portion can define the maximum width of the U-shaped fabric body, i.e., the base portion can be the widest portion of the fabric body.

[0105] The base portion may include a pair of wings which may extend wider than the outermost edges of the arms.

[0106] By providing a base portion that has an increased width, or at least a greater width compared to the arm portions, the base portion can be configured to provide greater lateral support to the fabric body upon implantation within body tissue.

[0107] When the anchoring system is in use, the base may be implanted on the atrial side of the leaflet if retention is required during heartbeat. In this regard, increased lateral support to the atrial location may be beneficial to achieve comprehensive support of the leaflet. When the base is on the atrial side, the arm(s) are on the ventricular side. They act to hold the anchoring system in place and provide some support, while the atrial portion (base) is more active in carrying the forces exerted on the leaflet by blood flow during heart contraction (systole).

[0108] The base portion may include a shape-retaining member configured to increase lateral stiffness of the base portion and to maintain a planar extent of the base portion or a 3D shape that conforms to the shape of the leaflet / anatomical structure.

[0109] By reinforcing the base portion with a shape-retaining member, the base portion can provide greater lateral support to the body tissue into which the fabric body is implanted. Furthermore, tension forces experienced by the fabric body during implantation when retaining an artificial line can be more evenly distributed across the base portion when a shape-retaining member is provided, thereby improving the stability of the fabric body during implantation.

[0110] The shape-retaining member may be formed from a resilient material. The base portion can include a folded configuration and an unfolded configuration, the shape-retaining member configured to bias the base portion from the folded configuration to the unfolded configuration upon removal of the restraining force. The base portion may be substantially planar in the unfolded configuration.

[0111] The shape-retaining member may be embedded in, interwoven with, and / or sandwiched between layers of the base portion.

[0112] The base portion may be formed by folding a portion of the fabric body over to sandwich the shape-retaining member therebetween. The shape-retaining member and / or the folded portion of the fabric body may be secured in place by adhesive, ultrasonic welding, welding or other suitable fastening means.

[0113] The shape-retaining member may include a fluorescent marker, which may aid in localization of the fabric body by imaging during implantation and / or retrieval.

[0114] The shape-retaining members may be formed from a shape-retaining metal such as stainless steel, titanium, nitinol, etc. The shape-retaining members may be formed by laser cutting or by shaping wires formed from similar materials.

[0115] The base portion can provide a surface for retrieval of the fabric body after implantation. The fabric body can be retrieved by pulling the arms out of the body tissue by grasping the base portion and pulling the base portion away from the body tissue. The shape-retaining member can make retrieval even easier, as the shape-retaining member can help distribute tension across the base portion during retrieval.

[0116] The shape-retaining member of the base can also act as a stop while the arms are being pulled through tissue by the guidewire, preventing the arm(s) from extending too far through the valve leaflets during deployment; in that way, the base in combination with the shape-retaining member can act to limit how far the deployment wire can advance during deployment.

[0117] The base portion may be configured to be gripped by a snare, and optionally the base portion may be located using a fluorescent marker. For example, the snare may encircle the arms that extend from the base portion first on the same side of the body tissue as the base portion when implanted. The snare may then be tightened so that the snare grips the base portion upon retraction. A pair of wings may provide a wide surface of the base portion along which the base portion may be gripped by the snare.

[0118] The base portion combined with the shape-retaining member can aid in placing the soft tissue anchor system in locations over larger areas of the leaflet (narrow and deep) while still achieving leaflet support.

[0119] The fabric body may include a thin body extending between the base portion and / or each arm portion. Upon implantation, the thin body may be aligned with the soft body tissue such that the thin body is surrounded by the soft body tissue at the implantation site. The thin body may be configured to be longer than the thickness of the soft body tissue in which the soft tissue anchoring system is to be implanted. For example, the length of the thin body may be at least 1 mm greater, at least 2 mm greater, or at least 3 mm greater. The length of the thin body may be 1-3 mm. The thin body may be considered similar to a portion of the arm portion, such that the arm portion(s) include a thin body at the end of the arm portion(s) proximal to the base portion, or alternatively may be considered a respective portion of itself as described above. The thin body may stabilize the implantation of the base portion adjacent to the body tissue. This feature may also help hold the arm portion(s) in place prior to tensioning the line.

[0120] Each arm may be provided with its own respective line, which may be an artificial line, i.e. a line acting as an implantable tether, and the lines may be secured to the central region of each tubular cap member as described above.

[0121] For example, in some configurations where the soft tissue anchor comprises at least two arms, the artificial line may be a line for one of the arms, and for the remaining arms, additional lines may be utilized, each secured (in sliding or immovable engagement) to the artificial line. Additionally or alternatively, two of the arms may comprise a reciprocal line, which is joined to the line of another arm adjacent to the artificial line / base. A first end of the line may be joined to the tubular cap member of the first arm, and a second end of the line may be joined to the tubular cap member of the second arm. A central portion of the line may then be secured to the artificial line / any other line.

[0122] If the line is threaded through the arm(s), each arm(s) may be provided with a hole in the base, a hole in the thin body, and at least one hole in the arm. The hole in the thin body may be located closer to the base than the arm (i.e., the hole may be located proximal to the base). This arrangement may improve compression of the fabric body around the soft body tissue, as locating the hole in the thin body proximal to the base encourages the base to fold / fold towards the arm(s) toward the soft body tissue, thus improving stability of the anchor system upon implantation.

[0123] If no thin body is provided, then for each arm(s), a hole in the base and at least two holes in the arm may be provided.

[0124] It will be appreciated that the above-described features of the arm(s) and base may be applicable to soft tissue anchor systems comprising one arm, as well as soft tissue anchor systems comprising at least two arm portions.

[0125] As discussed above, the artificial line may be joined to a portion of the line distal to the end fixed to the central portion. In some configurations, the artificial line may be slidably joined to a portion of the line threaded through the base portion. The artificial line may be configured to apply tension to the line.

[0126] The artificial line may be slidably joined to the line by any suitable knot, for example a bridle knot, or alternatively, by an intermediate member, such as an eyelet connected to the artificial line, through which the tension line passes.

[0127] By allowing the artificial line to slide relative to the tension line, the point at which tension is applied to the tension line can naturally adjust as tension is applied. This can help to spread the distribution of tension across each arm so that each arm is properly retracted. Additionally, such a configuration can facilitate implanting the fabric body in body tissue at an angle relative to the artificial line.

[0128] Alternatively, the artificial line may be fixedly attached to the line so that the relative position of the line and the artificial line does not change.

[0129] Instead of comprising a U-shaped fabric body, the soft tissue anchor system may comprise a plurality of "T-bar" anchors as described above. For example, the soft tissue anchor system may comprise at least two T-bar anchors, each configured to receive a wire guide member. The T-bar anchors may be joined to each other in line so as to be connected thereby.

[0130] In other words, according to another aspect of the present invention there is provided a soft tissue anchor system for implantation into soft body tissue to secure an artificial line, comprising a line and a plurality of tubular cap members, an end of the line secured to each tubular cap member and extending from a central portion thereof such that, in use, each tubular cap member, when implanted in the soft body tissue, extends in a plane parallel to a surface of the soft body tissue and is configured to extend under tension of the line as it passes through the tissue in an outward direction from that surface, each tubular cap member comprising an opening configured to receive a wire guide member for passing the tubular cap member through the soft body tissue during implantation.

[0131] In use, each opening may be configured to receive a respective wire guide member such that each tubular cap member is simultaneously implanted in body tissue. Alternatively, in use, each opening may be configured to receive mutual wire guide members such that each tubular cap member is sequentially implanted in body tissue.

[0132] Each T-bar anchor may be provided with its own respective line. Each line may be an artificial line, i.e. a line acting as an implantable tether. Alternatively, a line may be fixed to each tubular cap member / T-bar anchor.

[0133] For example, in some configurations where the soft tissue anchor comprises at least a T-bar anchor, the artificial line may be the line for one of the T-bar anchors, and for the remaining T-bar anchors, additional lines may be utilized, each secured (in sliding or immovable engagement) to the artificial line. Additionally or alternatively, two of the T-bar anchors may comprise an interline, which is joined to the artificial line / line of another T-bar anchor. A first end of this interline may be joined to the tubular cap member of the first T-bar anchor, and a second end of the line may be joined to the tubular cap member of the second T-bar anchor. The central portion of the line may then be secured to the artificial line / any other line. The interline may also be considered a fixation between any line also connected to the tubular cap member.

[0134] The tension line may include a plurality of bridle lines, each bridle line associated with a respective tubular cap member (i.e., an end of each bridle line is secured to a respective tubular cap member).

[0135] Each bridle line is preferably connected to a common bridle point that is configured to place each bridle line under tension when the soft tissue anchor system is embedded in the soft body tissue and the bridle point is itself under tension, i.e., the bridle point is configured to place each bridle line under tension as it passes through the tissue in a direction outward from the surface of the soft body tissue and when the bridle point is itself under tension.

[0136] By providing a configuration with multiple bridle lines each under tension resulting from a common bridle point, the tubular cap members of the soft tissue anchor can each be subjected to tension that pulls them toward a plane or axis that intersects the bridle point, in the direction of the tension applied to the bridle point. This can drive each tubular cap member toward one another to capture, collect, and / or pinch any excess body tissue located between the tubular cap members upon implantation. This configuration can thus restore the shape of the soft body tissue and / or provide additional structural support to the body tissue.

[0137] A configuration with multiple bridle lines, each connected to a common bridle point, may be particularly advantageous when the soft body tissue is a heart valve leaflet. It has been found that reshaping of the leaflet tissue resulting from the capture of excess leaflet tissue as described above produces similar results to the resection of the leaflet. Resection is a common surgical step in existing methods of heart valve repair, in which a surgeon resects a damaged section of the heart valve and sutures the remaining tissue edges together. Resection is often performed when excess leaflet tissue is present. However, by providing a line configuration that includes a bridle point and multiple bridle lines, the need for the resection step can be eliminated. This can simplify the overall surgical procedure.

[0138] In the described embodiment, the lines may be considered to be in a bridle configuration, which comprises a plurality of bridle lines. An end (i.e., a first end) of each bridle line is secured to and extends from a central portion of a respective tubular cap member such that, in use, each tubular cap member is configured to extend in a plane parallel to the surface of the soft body tissue when embedded in the soft body tissue and to be under the tension of the bridle line as it passes through the tissue in an outward direction from the surface. Each bridle line is further secured at a second end to a bridle point, or alternatively to another tubular cap member to which the central portions of the bridle lines are connected at a common bridle point.

[0139] The bridle point may be a fixed bridle point such that the bridle lines cannot move relative to the bridle point at the connection. The bridle point may be a fixed knot, an eye plate, or other suitable fastener.

[0140] Alternatively, the bridle point may be a slidable bridle point so that the bridle lines can move relative to the bridle point at the connection. The bridle lines may be self-adjusting as described above. The bridle point may be a bridle knot with a single inter-line providing multiple bridle lines.

[0141] The artificial line may be connected to the bridle point and may be configured to apply tension to the bridle point, i.e., place the bridle point under tension.

[0142] The artificial line may form one of the bridle lines. The remaining bridle lines may be joined to the artificial line at bridle points located along the artificial line.

[0143] The bridle point is preferably positioned to provide each of a plurality of bridle lines on a first side of the bridle point with a single tension and / or artificial line located on a second side of the bridle point opposite the first side, such a configuration may provide a more consistent distribution of tension from the bridle point to each of the bridle lines.

[0144] The multiple bridle lines may be comprised of two bridle lines, in which case the bridle configuration may comprise a Y-shaped configuration.The multiple bridle lines may be comprised of three bridle lines, in which case the bridle configuration may comprise a trifurcated configuration.

[0145] According to a second aspect of the present invention there is provided a soft tissue anchor system for implantation into soft body tissue to retain an artificial line, the soft tissue anchor system comprising a U-shaped woven body comprising a base portion and at least two arms extending from the base portion, each arm portion configured to be folded towards the base portion such that in use body tissue is sandwiched between the base portion and each arm portion.

[0146] By providing a fabric body including two or more arms extending from the same base, the anchoring system may be able to contact a larger surface area of ​​body tissue when implanted and therefore have improved stability and / or improved tissue ingrowth when implanted. Furthermore, by providing a foldable arm(s) attached via the base, it may further be possible for the base itself to provide a larger surface area for connecting the anchoring system with the valve leaflets when implanted. A U-shaped anchoring system, i.e., a U-shaped anchoring system having at least two arms, may provide improved performance compared to a single arm.

[0147] Thus, soft tissue anchor systems as described above may have improved fixation strength compared to known anchor systems that include a single arm and / or fixation member and / or use different design features.

[0148] Additionally, the use of a fabric body as compared to a rigid body such as a metal body can reduce damage to body tissue caused by the anchor during and / or after implantation. The fabric can better complement the surface of the body tissue it contacts, thus distributing the forces exerted on the body tissue over a larger area and reducing the trauma experienced by the body tissue at the implantation site.

[0149] The folding of the arms towards the base can be thought of as a bellows motion, and therefore the arms may also be configured to bellow towards the base such that in use, body tissue is sandwiched between the base and the arms.

[0150] A fabric body formed from a fabric material may be naturally arranged to fold and / or bellow due to the conformable nature of the fabric, however, in some configurations, the arms may include fold lines, constrictions, and / or weakened portions configured to assist in the folding and / or bellows movement of the arms.

[0151] In one configuration, the arm portion may be configured to fold toward the base portion by the action of a tension line threaded through the arm portion and the base portion. If two arm portions are used, each may have its own tension line. Thus, the tension line may advantageously be configured to cause the arm portion to fold toward the base portion when tension is applied to the tension line. It will be appreciated that each tension line may act as an implantable cord (i.e., the tension line may be an artificial line).

[0152] The tension line is preferably secured to the arm at an end of the arm distal to the base, and may thus be configured such that when tension is applied to the tension line, the entire arm collapses towards the base.

[0153] The locations through which the tension lines are routed can facilitate the folding of the arms. For example, when a tension line is pulled, it can pull into holes in the arms that the tension line is routed through together. Thus, the arms can be biased to collapse for each location through which the tension line is routed.

[0154] Preferably, the anchoring system is configured such that tension is applied to the portion of the tension line(s) that is routed through the base portion. This configuration can facilitate folding of the entire arm portion.

[0155] The line may be threaded through the arm and base portions only three or four times. This configuration may facilitate the holes in the fabric body through which the line is threaded being spaced further apart and / or a shorter fabric body being utilized. Relative to the size of the anchor, each of these configurations may provide a wider folded portion of the fabric body that improves the stability of the anchor system upon implantation. Using a shorter fabric body may also reduce the overall size of the soft tissue anchor system, thus improving its packaging within a delivery device / system for implantation.

[0156] The soft tissue anchoring system may comprise an artificial line, i.e. the fabric body may be combined with an artificial line.

[0157] The artificial line may be fixedly attached to the line so that the relative position of the line and the artificial line does not change.

[0158] The artificial line may be slidably joined to the portion of the tension line that is threaded through the base portion. The artificial line may be arranged to apply tension to the tension line.

[0159] Alternatively, the artificial line may be slidably joined to the tension line by any suitable knot, for example a bridle knot. Alternatively, the artificial line may be slidably joined to the tension line by an intermediate member, such as a grommet connected to the artificial line, through which the tension line passes.

[0160] By allowing the artificial line to slide relative to the tension line, the point at which tension is applied to the tension line can naturally adjust as tension is applied. This can help to spread the distribution of tension across each arm so that each arm is properly retracted. Additionally, such a configuration can facilitate implanting the fabric body in body tissue at an angle relative to the artificial line.

[0161] The fabric body may optionally include a reinforcing member defining a plurality of holes through which the tension lines are threaded. The reinforcing member may be implemented, for example, as a tension member that provides additional tensile strength to the fabric body. The reinforcing member may be considered the backbone of the fabric body and may preferably include a shape complementary to the fabric body. The tension lines may preferably be threaded through the reinforcing member in addition to the fabric body. The reinforcing member may define holes through which the tension lines are threaded. The reinforcing member may be embedded in the fabric body. The reinforcing member may be interwoven with the fabric body. The reinforcing member may be sandwiched between layers of the fabric body.

[0162] The reinforcing member may be at least one high tensile strength line woven into the fabric to take excessive tensile loads that may be applied to the fabric during embedding, retraction, or along its life cycle.

[0163] The reinforcing members can strengthen the fabric body and provide additional support at the points where tension lines are threaded through the fabric body, as well as optionally at the points where end caps are attached, and at any points along the length of the fabric where the fabric narrows, thus improving the structural integrity of the fabric body.

[0164] Additionally or alternatively, the arms may be configured to fold toward the base due to the presence of a backbone formed from a resilient material. The resilient material may be a shape memory metal such as Nitinol. The backbone may be in contact with at least each arm and may also be in contact with the base. The backbone may be embedded in or interwoven with the fabric body and / or sandwiched between layers of the fabric body.

[0165] The backbone can include a folded configuration and an unfolded configuration. The backbone can be held in the unfolded configuration by application of a restraining force. In the unfolded configuration, the arms can extend outwardly from the base. Upon removal of the restraining force, the backbone can return to a folded portion in which the backbone includes one or more folds. The arms occupy the same shape as the backbone due to the contact between them. Thus, the backbone can be a resiliently biased backbone configured to bias the arms towards the base to fold.

[0166] If a backbone is utilized, the lines may be threaded through the arms.

[0167] As discussed above, (i) the configuration in which the line is threaded through the arm portion, and (ii) the configuration in which the base portion and backbone are formed from an elastic material, can each be considered as different means for folding the arm portion toward the base portion.

[0168] In other words, according to another aspect of the present invention there is provided a soft tissue anchor system for implantation into soft body tissue to retain a line, the soft tissue anchor system comprising a U-shaped woven body comprising a base portion and at least two arms extending from the base portion, and means for folding each arm portion towards the base portion such that, in use, body tissue is sandwiched between the base portion and each arm portion.

[0169] In alternative terms, the means for folding the arm portion towards the base portion may be considered equally as a mechanism for folding the arm portion towards the base portion, and / or a folding mechanism configured to fold the arm portion towards the base portion, including at least one of: (i) a configuration in which a line is threaded through the arm portion; and (ii) a configuration in which the base portion and the backbone are formed from an elastic material, without departing from the above aspects.

[0170] The artificial line may be joined to the fabric body via the base portion using any suitable fastening arrangement.

[0171] The tension lines and / or artificial lines may be formed from suture material.

[0172] Each arm may include an end cap secured to an end of each arm distal to the base, and each end cap may include an opening configured to engage a wire guide member for implanting the fabric body in body tissue, and the end cap may be considered a tubular cap member.

[0173] By providing an end cap that includes an opening configured to engage a wire guide member for implanting the fabric body, the arms can be manipulated so that they can be implanted through body tissue, for example, the wire guide member can push the arms in their engagement direction so that they pass through body tissue.

[0174] Furthermore, by using a wire guide member to guide the arms through the body tissue, rather than a needle from which the arms are deployed, the bodily tissue hole through which each arm passes does not need to be as large as the hole required for the needle or other conduit containing the arm to pass through; that is, the size of the opening is constrained only by the geometry of the fabric body. In comparison, the size of the opening required for needle-based implantation is always constrained by the size of the needle, which is always larger than the deploying member. This can reduce trauma at the implantation site.

[0175] The anchoring system can include a tension line (e.g., as described above) that can be secured to the end cap and extend from a central portion thereof such that, in use, the end cap is configured to extend in a plane parallel to a surface of the soft body tissue when embedded in the tissue and to be under tension of the line as it passes through the tissue in a direction outward from the surface.

[0176] The end cap can include a first end, a second end distal to the first end, and a sidewall extending between the first and second ends. The opening can be disposed in the first end of the end cap. The second end of the end cap can define a tip of the tubular cap member, the tip configured to be inserted into soft body tissue.

[0177] The central portion of the end cap can be considered to be the portion of the end cap located about the geometric center of the end cap (i.e., the center point along the longitudinal axis of the end cap), which portion includes less than 30% of the length of the end cap, less than 40% of the length of the end cap, less than 50% of the length of the end cap, or less than 60% of the length of the end cap. The central portion of the end cap can be considered to include the "middle third" of the length of the end cap. In other words, the central portion of the end cap can include any point on the end cap that is closer to the geometric center of the end cap than either the first end or the second end.

[0178] In some examples, the line may be substantially central, that is, extend substantially centrally from the center of the end cap (eg, coincident with the geometric center of the end cap). In other examples, the line may extend asymmetrically, and thus extend from a point along the end cap more toward the first end or the second end of the end cap (but still within a central portion of the end cap).

[0179] For example, the asymmetric arrangement can be a point from which the line extends from the end cap distally from the opening (i.e., toward the tip of the end cap). Having the line extend from a point located toward the tip of the end cap can facilitate torqueing the end cap into a "T" configuration. However, in other preferred examples, a point from which the line extends from the end cap proximally to the opening (i.e., toward the opening of the end cap). Having the line extend from a point located toward the opening of the end cap can better distribute the contact force exerted by the end cap when implanted and extending in a plane parallel to the fold / body tissue surface under tension of the line. The end cap can have a smaller projected area closer to the tip (e.g., due to a taper and / or bevel at the tip). The end cap can have a larger projected area closer to the opening (e.g., due to no taper / end cap widening toward the opening). Thus, by locating the point at which the line extends from the end cap proximal to the opening, a more balanced distribution of the contact forces exerted by the profile of the tubular cap member as it extends in a plane parallel to the fold / body tissue surface can be achieved.

[0180] Thus, the line can extend from a central portion of the end cap to which it is secured, substantially to the center of the end cap, toward the first end of the end cap, or toward the second end of the end cap, as described above.

[0181] The manner in which the end of the line is secured to the end cap can cover the length of the end cap. For example, the length of the end of the line may be wrapped circumferentially around the end cap or a portion thereof, and this length of the line additionally extends along the axial length of the end cap (i.e., in a spiral or coil). The line extending from the end cap may extend from this coiled portion of the line. Alternatively, the length of the end of the line or a portion thereof secured to the end cap may extend substantially axially along the end cap or a portion thereof. The line extending from the end cap may extend from this length of the line.

[0182] The end of the line may be secured to a central portion of the end cap. However, the end of the line need not be limited to being secured to a central portion of the end cap, provided that the line extends from the central portion of the end cap. Thus, in another phrase, the soft tissue anchor system may be thought of as having the end of the line secured to a central portion of the end cap, and this particular description of the end of the line refers to the portion of the line that first extends from the end cap (i.e., is the "end" portion of the line that determines the location along the end cap where tension can be applied to the end cap by the line in use).

[0183] The end cap may include an outer tubular member and an inner tubular member configured to be received by the outer tubular member (i.e., the inner tubular member may be nested within and / or concentric with the outer tubular member). The inner tubular member may define an opening configured to engage the wire guide member.

[0184] The outer tubular member and the inner tubular member may be configured to sandwich, crimp, and / or clamp the distal ends of the respective arms therebetween to secure the end caps to the arms. An adhesive may additionally or alternatively be used to secure the end caps to the arms.

[0185] In one configuration, the outer tubular member and the inner tubular member each define an opening extending along their entire length, i.e., they are hollow along their entire length. The inner tubular member can be configured to pass a piercing section of the wire guide member and can be configured to abut a shoulder or bulge of the wire guide member. A wire guide member including a piercing section configured to pierce body tissue during implantation of the anchoring system can be considered a piercing wire guide member.

[0186] By allowing the penetrating wire guide member to pass through the inner tubular member, the end cap can include a blunt and / or rounded tip while still allowing for puncture of body tissue during implantation of the anchoring system. Additionally, by providing the inner tubular member configured to abut a shoulder or bulge on the wire guide member, proper contact for manipulation of the arms through the penetrating wire guide member can be achieved.

[0187] Moreover, the use of an end cap suitable for use with a puncture wire guide member can further reduce trauma to the implantation site because the puncture section of the wire guide member can have a smaller diameter than, for example, the hollow needle member that makes the incision for implantation.

[0188] The inner tubular member may extend from the outer tubular member and may define a distal end of the end cap. This configuration provides a gradual transition between the inner and outer tubular members at the distal end of the end cap, which may facilitate smoother passage of the end cap through body tissue during implantation.

[0189] Alternatively, the outer tubular member may include a tapered portion located at the tip of the end cap, i.e., the tip of the end cap may be defined by the outer tubular member, and the end of the inner tubular member may be housed within the outer tubular member. This configuration provides a continuous transition between the tip of the end cap and the outer tubular member located at the tip of the end cap, which may facilitate smoother passage of the end cap through body tissue during implantation.

[0190] The inner tubular member may include a flared inlet defining an opening configured to engage the wire guide member, the flared inlet being understood to be a portion of the inner tubular member defining the opening, the circumferential extent of the inner tubular member increasing relative to the remainder of the inner tubular member.

[0191] Preferably, the flared entrance includes an angled surface to facilitate guiding the wire guide member into the inner tubular member, which may be preferred when the wire guide member is not received by the opening in the tubular cap member prior to implantation.

[0192] The flared entrance may be configured to mate with a corresponding portion of the wire guide member. That is, the flared entrance may be complementary to the shape of a shoulder region or bulge of the piercing wire guide member. The beveled surface of the flared entrance may be complementary to, for example, a shoulder region or bulge of the wire guide member. The flared entrance may improve contact between the wire guide member and the end cap during implantation of the fabric body.

[0193] The inner tubular member may be retained within the outer tubular member via a press fit and / or mating notches. The inner tubular cap member may also, or alternatively, be retained within the outer tubular member via a crimping action.

[0194] The flared inlet may be configured to position the inner tubular member within the outer tubular member. An end of the inner tubular member proximal to the opening may mate with the outer tubular member via a mating notch, a press fit, and / or a crimp connection. The flared inlet may provide a press fit between the inner tubular member and the outer tubular member. An end of the inner tubular member distal to the opening may also mate with the outer tubular member via a mating notch, a press fit, and / or a crimp connection. Providing at least two retention areas or points may improve retention strength of the inner tubular member within the outer tubular member.

[0195] The outer tubular member can include a shoulder region distal to the opening configured to mate with the inner tubular member, which can facilitate positioning of the inner tubular member within the outer tubular member such that the opening defined by the inner tubular member is properly positioned over the end of the tubular cap member.

[0196] The tip of the end cap distal to the base may be a blunt and / or rounded tip. Having a blunt and / or rounded tip reduces the risk of laceration and / or further trauma to body tissue caused by the end cap upon implantation or otherwise.

[0197] The tip of the end cap may be located at the end of the end cap distal to the arm (ie, the end of the end cap distal to the opening configured to engage the wire guide member).

[0198] In an alternative configuration, each end cap may include a tip that may be configured to pierce body tissue, for example, when a driving force is applied to the end cap by the wire guide member.

[0199] The tip of the end cap may be located at the end of the end cap distal to the arm (ie, the end of the end cap distal to the opening configured to engage the wire guide member).

[0200] The tip may include a conical tip, i.e. a tip having rotational symmetry about the longitudinal axis of the tubular cap member.

[0201] Alternatively, the tip may have a rotationally asymmetric shape about the longitudinal axis of the tubular cap member. The use of a rotationally asymmetric tip shape for the tip can facilitate the tip having a higher draft angle relative to the plane of its point (i.e., the plane of its shear edge). The use of a tip with a higher draft angle can reduce the force required for the tip to pierce soft body tissue and therefore the trauma experienced at the implantation site during implantation.

[0202] To this end, the tip may include a beveled surface, which is understood to define a single plane, i.e., a plane where the surface of the bevel is ground (e.g., a ground surface) or formed in any other manner.

[0203] The bevel surface can define a surface of a pointed end. The bevel surface can have a draft of greater than 50°, greater than 60°, greater than 70°, or greater than 80° relative to a radial surface of the tubular cap member. The bevel surface can have a draft of less than 10°, less than 20°, less than 30°, or less than 40° relative to a longitudinal axis of the tubular cap member.

[0204] The point may include a single beveled surface and may be described as a beveled tip or a chisel tip.

[0205] Alternatively, the tip may include two lancet faces in addition to the bevel face. The lancet face may be adjacent to the bevel face, preferably symmetrically. Each of the bevel face and the lancet face is understood to define a respective surface (such as a ground surface). Such a tip shape may be described as a lancet point tip. Thus, the tip may be a lancet tip.

[0206] In configurations where the opening configured to receive the wire guide member includes a blind hole or blind hole hollow, the tip can be considered a pointed stylet, and in configurations where the opening configured to receive the wire guide member extends completely through the tubular cap member (such a configuration simplifies manufacture of the tubular cap member), the tip can be considered a pointed cannula.

[0207] The tip may be a retractable tip. The tip of the end cap may have a first position in which the tip is a sharp tip, i.e. the tip is deployed, and a second position in which the tip is a blunt and / or rounded tip, i.e. the tip is retracted. The second position may be a rest position of the retractable tip. The retractable tip may be biased from the second position to the first position via engagement of the wire guide member with the end cap.

[0208] The outer tubular member can define a tip. If the tip is permanently present, the inner tubular member can include a blind hole that receives the wire guide member. If the tip is a retractable tip, the inner tubular member can be hollow such that the wire guide member can actuate the retractable tip and / or any suitable deployment mechanism.

[0209] The tension line may be secured to the end cap. The end cap may be configured to receive the tension line between the inner tubular member and the outer tubular member. The tension line may be secured to the end cap by crimping, swaging, clamping, gluing and / or sandwiching the tension line between the inner tubular member and the outer tubular member. The tension line may also be secured by suturing it or tying it to the tubular member.

[0210] The outer tubular member can include an opening formed in a sidewall, the opening configured to receive the tension line. The opening may be formed in a central region of the end cap, and more preferably, the opening may be formed toward the tip of the end cap.

[0211] Each end cap may be configured to extend collinearly with a respective arm during embedding and / or retrieval of the U-shaped fabric body. Each end cap may also be configured to extend parallel to the plane of each fold of a respective arm when tension is applied to the tension line.

[0212] The arms may be secured to the ends of the end caps proximal to the arms, and the tension lines may be secured toward a central region of the end cap and / or toward a distal tip relative to the arms, such that tension applied by the arms and / or tension lines can apply a torque to the end caps.

[0213] Thus, when the wire guide member engages the end cap, the end cap straightens and extends in a line with the arms. This allows the arms of the fabric body to be easily embedded in the body tissue. When the tension line is under tension, thus folding the arms, the tension line can rotate the end cap to be parallel to the fold of the arms and therefore parallel to the surface of the body tissue on which the arms are folded. This can facilitate the fixation of the arms to the body tissue and can also minimize the profile of the end cap protruding from the body tissue during embedding. For example, the end cap can be rotated perpendicular to the tension line in a "T" configuration, with the tension line perpendicular to the surface of the body tissue and the length of the end cap parallel to the surface of the body tissue, preventing movement of the end cap through the body tissue. When the fabric body portion is retrieved from the body tissue, for example by being pulled from the distal direction of the end cap, the tension acting through the arms can self-correct the end cap from a parallel position to extend in a line with the arms during retrieval. Thus, by connecting the arms at their ends to the end caps, tension from the arms will tend to straighten the end caps (e.g., from the "T" configuration described above), thereby allowing the end caps to align with the arms and therefore with the holes through the body tissue. This can facilitate retrieval and minimize any trauma to the body tissue during retrieval.

[0214] The end cap may be formed of a suitably rigid biocompatible material capable of retaining its shape, such as stainless steel, titanium, engineering plastics, or nitinol. The end cap may be a single component (e.g., a hollow tube) with the tension lines tied or secured to the tube. The end cap may be formed as a single component by laser cutting or machining nitinol or stainless steel.

[0215] The outer tubular member of each end cap may include a groove, channel, opening, or other suitable feature for guiding the arms between the outer tubular member and the inner tubular member. The groove, channel, opening, or other suitable feature may be formed in circumferential alignment with an opening or aperture in the line, and may also be formed at or toward an opening configured to receive a wire guide member. Providing the line and arms in alignment with one another may improve stability of the soft tissue anchor system when implanted in soft body tissue.

[0216] By fixing the arms towards the opening in the end cap and fixing the line to the central portion of the tubular cap member, it is possible to easily apply a torque to the end cap when the line is under tension, thereby allowing the end cap to lie flat against the soft body tissue during implantation.

[0217] Securing the arms towards and / or at the opening of the end cap can also facilitate retrieval of the end cap. For example, tension on the line can be relieved upon retrieval of the soft tissue anchor system. The arms / fabric body can then be pulled to apply tension. As a result of this tension, a torque can be applied to the end cap, causing it to rotate so that it extends in a plane perpendicular to the surface of the soft body tissue (e.g., so that it extends collinearly with the line). The tubular cap member can then be pulled and / or guided back through the soft body tissue. This configuration can thus facilitate retrieval of the end cap during retrieval of the soft tissue anchor system, so as to minimize any trauma to the body tissue during retrieval.

[0218] Alternatively, an opening formed in the sidewall of the outer tubular member that receives the line may receive the arm, and thus, securing of the arm and line to the end cap may be simultaneous.

[0219] Alternatively, the outer tubular member may not include a flared entrance defining a channel for guiding the arms between the outer and inner tubular members and / or an opening configured to receive the wire guide member, as may be preferred in configurations where the wire guide member is received by an opening in the end cap prior to implantation. As a result, the end cap may be made shorter and / or thinner (i.e., narrower in diameter) and therefore more compact for configurations where a wire guide member does not need to be guided into engagement with the end cap during implantation.

[0220] The fabric body may be formed from a single layer of fabric or multiple layers of fabric. In this context, a fabric may be considered a material formed as a woven fabric made from threads or thread-like forms. One possible material is polyester fabric, other materials include fabrics of PET, UHMPE, EPTFE, PTFE, etc. The fabric body may be formed from any suitable flexible, conformable and biocompatible material. The fabric body may be formed by laser cutting existing materials or any other suitable manufacturing technique.

[0221] In the examples herein using at least two arms, the U-shaped body is said to result from the U-shape formed by the base and the two arms. However, it is understood that this simply refers to the unit structure of the fabric body having two arms, and the shape will be different when more arms are present. For example, a fabric body including three arms can be considered as a W-shaped body, and the W-shaped body includes two U-shaped units. Thus, the anchoring system may include a fabric body including multiple U-shaped units so that a fabric body of an appropriate size can be achieved for the desired purpose of the soft tissue anchoring system.

[0222] The base portion may be the widest portion of the fabric body, i.e., the base portion may define the maximum width of the fabric body.

[0223] The base portion may include a pair of wings which may extend wider than the outermost edges of the arms.

[0224] By providing a base portion that has an increased width, or at least a greater width compared to the arm portions, the base portion can be configured to provide greater lateral support to the fabric body upon implantation within body tissue.

[0225] When the anchor is in use, the base may be implanted on the atrial side of the leaflet if retention is required during heartbeat. In this regard, increased lateral support to the atrial location may be beneficial to achieve comprehensive support of the leaflet. When the base is on the atrial side, the arms are on the ventricular side. They act to hold the anchor system in place and provide some support, but the atrial portion (base) is more active in carrying the forces exerted on the leaflet by blood flow during heart contraction (systole).

[0226] The base portion may include a shape-retaining member. The shape-retaining member may be configured to increase the rigidity of the base portion. The shape-retaining member may be configured to maintain a planar extent of the base portion or a 3D shape that conforms to the shape of the valve leaflet / anatomical structure.

[0227] By reinforcing the base portion with a shape-retaining member, the base portion can provide greater lateral support to the body tissue into which the fabric body is implanted. Furthermore, tension forces experienced by the fabric body during implantation when retaining an artificial line can be more evenly distributed across the base portion when a shape-retaining member is provided, thereby improving the stability of the fabric body during implantation.

[0228] The shape-retaining member may be formed from a resilient material. The base portion can include a folded configuration and an unfolded configuration, the shape-retaining member configured to bias the base portion from the folded configuration to the unfolded configuration upon removal of the restraining force. The base portion may be substantially planar in the unfolded configuration.

[0229] The shape-retaining member may be embedded in, interwoven with, and / or sandwiched between layers of the base portion.

[0230] The base portion may be formed by folding a portion of the fabric body over to sandwich the shape-retaining member therebetween. The shape-retaining member and / or the folded portion of the fabric body may be secured in place by adhesive, ultrasonic welding, welding or other suitable fastening means.

[0231] The shape-retaining member may include a fluorescent marker, which may aid in localization of the fabric body by imaging during implantation and / or retrieval.

[0232] The shape-retaining members may be formed from a shape-retaining metal such as stainless steel, titanium, nitinol, etc. The shape-retaining members may be formed by laser cutting or by shaping wires formed from similar materials.

[0233] The base portion can provide a surface for retrieval of the fabric body after implantation. The U-shaped fabric body can be retrieved by pulling the arms out of the body tissue by grasping the base portion and pulling the base portion away from the body tissue. The shape-retaining member can further facilitate retrieval because the shape-retaining member can help distribute tension across the base portion during retrieval.

[0234] The shape-retaining member of the base can also act as a stop while the arms are being pulled through tissue by the guidewire, preventing the arms from extending too far through the valve leaflets during deployment; in that way, the base in combination with the shape-retaining member can act to limit how far the deployment wire can advance during deployment.

[0235] The base portion may be configured to be gripped by a snare, and optionally the base portion may be located using a fluorescent marker. For example, the snare may encircle the arms that extend from the base portion first on the same side of the body tissue as the base portion when implanted. The snare may then be tightened so that the snare grips the base portion upon retraction. A pair of wings may provide a wide surface of the base portion along which the base portion may be gripped by the snare.

[0236] The arms may include a thin body extending between the base and each arm. Upon implantation, the thin body may be aligned with the soft body tissue such that the thin body is surrounded by the soft body tissue at the implantation site. The thin body may be configured to be longer than the thickness of the soft body tissue in which the soft tissue anchor system is to be implanted. For example, the length of the thin body may be at least 1 mm or at least 2 mm or at least 3 mm. The length of the thin body may be between 1 and 3 mm. Each thin body may be considered as a portion of a respective arm, such that each arm includes a thin body at the end of the arm proximal to the base, or alternatively may be considered as a respective part of itself as described above. The thin body may stabilize the implantation of the base adjacent to the body tissue. This feature may also help hold the arms in place prior to tensioning the tension lines.

[0237] Each arm may be provided with its own respective line. For example, in some configurations where the soft tissue anchor comprises at least two arms, the artificial line may be the line for one of the arms, and for the remaining arms additional lines may be utilized, each secured (in sliding or immovable engagement) to the artificial line. Additionally or alternatively, two of the arms may comprise a reciprocal line, which is joined to the artificial line / line of another arm adjacent to the base. A first end of the line may be joined to the end cap of the first arm, and a second end of the line may be joined to the end cap of the second arm. The central portion of the line may then be secured to the artificial line / any other line.

[0238] If the line is threaded through the arms, each arm may be provided with a hole in the base, a hole in the narrow body, and at least one hole in the arm. The hole in the narrow body may be located closer to the base than the respective arm (i.e., the hole may be located proximal to the base). This arrangement may improve compression of the fabric body around the soft body tissue, as locating the hole in the narrow body proximal to the base encourages folding of the base towards / folding towards the soft body tissue. Thus, the stability of the anchor system during implantation may be improved.

[0239] If no thin body is provided, then for each arm(s), a hole in the base and at least two holes in the arm may be provided.

[0240] The base portion combined with the shape-retaining member can aid in placing the soft tissue anchor system in locations over larger areas of the leaflet (narrow and deep) while still achieving leaflet support.

[0241] The tension line may include multiple bridle lines, each bridle line associated with a respective arm portion (i.e., threaded through a base portion and associated with a respective arm portion).

[0242] Each bridle line is preferably connected to a common bridle point which is configured to place each bridle line under tension when tension is applied to the bridle point, i.e. the bridle point is configured to apply tension to each bridle line when the bridle point is itself under tension.

[0243] By providing a configuration with multiple bridle lines each under tension resulting from a common bridle point, the arms (and / or end caps, if present) of the soft tissue anchor can each be subjected to tension that pulls them toward a plane or axis that intersects the bridle point, in the direction of the tension applied to the bridle point. This can drive each arm toward one another to capture, collect, and / or pinch any excess body tissue located between the arms upon implantation. This configuration can thus restore the shape of the soft body tissue and / or provide additional structural support to the body tissue.

[0244] A configuration with multiple bridle lines, each connected to a common bridle point, may be particularly advantageous when the soft body tissue is a heart valve leaflet. It has been found that reshaping of the leaflet tissue resulting from the capture of excess leaflet tissue as described above produces similar results to the resection of the leaflet. Resection is a common surgical step in existing methods of heart valve repair, in which a surgeon resects a damaged section of the heart valve and sutures the remaining tissue edges together. Resection is often performed when excess leaflet tissue is present. However, by providing a line configuration that includes a bridle point and multiple bridle lines, the need for the resection step can be eliminated. This can simplify the overall surgical procedure.

[0245] In the described embodiment, the lines may be considered to be in a bridle configuration, which comprises a plurality of bridle lines, each threaded through each of the arm sections and the base section (and each bridle line may have its end secured to a respective end cap), each bridle line configured to fold each arm section towards the base section when tension is applied to the bridle lines by the bridle points, each bridle line connected to the bridle points at a location on the base section opposite the arm sections.

[0246] The bridle point may be a fixed bridle point such that the bridle lines cannot move relative to the bridle point at the connection. The bridle point may be a fixed knot, an eye plate, or other suitable fastener.

[0247] Alternatively, the bridle point may be a slidable bridle point so that the bridle lines can move relative to the bridle point at the connection. The bridle lines may be self-adjusting as described above. The bridle point may be a bridle knot with a single inter-line providing multiple bridle lines.

[0248] The artificial line may be connected to the bridle point and may be configured to apply tension to the bridle point, i.e., place the bridle point under tension.

[0249] The artificial line may form one of the bridle lines. The remaining bridle lines may be joined to the artificial line at bridle points located along the artificial line.

[0250] The bridle point is preferably positioned to provide each of a plurality of bridle lines on a first side of the bridle point with a single tension and / or artificial line located on a second side of the bridle point opposite the first side, such a configuration may provide a more consistent distribution of tension from the bridle point to each of the bridle lines.

[0251] The multiple bridle lines may be comprised of two bridle lines, in which case the bridle configuration may comprise a Y-shaped configuration.The multiple bridle lines may be comprised of three bridle lines, in which case the bridle configuration may comprise a trifurcated configuration.

[0252] In a variation of the soft tissue anchor system of the second embodiment, the soft tissue anchor system may include only one arm rather than at least two thereof, and it is contemplated that certain advantages may be achieved with only one arm and using other features such as end caps, as discussed above.

[0253] Thus, according to another aspect, there is provided a soft tissue anchor system for implantation into soft body tissue to retain a line, the soft tissue anchor system comprising a woven body including a base portion and at least one arm portion extending from the base portion, each arm portion configured to be folded towards the base portion in use such that body tissue is sandwiched between the base portion and each arm portion, each arm portion comprising an end cap secured to an end of each arm portion distal to the base portion, each end cap configured to receive a wire guide member for implanting the anchor into body tissue and to pull the arm portion through the body tissue during implantation.

[0254] The soft tissue anchor system of any of the above aspects may be a valve anchor system for implantation into a heart valve leaflet for securing a prosthetic chordae line. The heart valve leaflet may be a mitral valve leaflet or a tricuspid valve leaflet.

[0255] According to a third aspect of the present invention there is provided a soft tissue anchor system for implantation into soft body tissue for anchoring an artificial line, the soft tissue anchor system comprising a plurality of anchor members and a bridle arrangement comprising a plurality of bridle lines and a common bridle point, each bridle line being associated with a respective anchor member and connected to the common bridle point, the bridle points being configured to place each bridle line under tension when the soft tissue anchor system is embedded within the soft body tissue and the bridle points are themselves under tension, such that each anchor member is driven towards an axis that intersects the bridle point and in the direction in which tension is applied to the bridle points.

[0256] By providing a bridle configuration with multiple bridle lines each under tension resulting from a common bridle point, the anchor members of the soft tissue anchor system can each be subjected to a tension that pulls them toward a plane or axis that intersects the bridle point, in the direction of the tension applied to the bridle point. This can drive each anchor member toward one another to capture, collect, and / or pinch any excess body tissue located between the anchor members upon implantation. This configuration can thus restore the shape of the soft body tissue and / or provide additional structural support to the body tissue.

[0257] A bridle configuration comprising multiple bridle lines each connected to a common bridle point may be particularly advantageous when the soft body tissue is a heart valve leaflet. It has been found that reshaping of the leaflet tissue resulting from the capture of excess leaflet tissue as described above produces similar results as resection of the leaflet. Resection is a common surgical step in existing methods of heart valve repair, in which a surgeon resects a damaged section of the heart valve and sutures the remaining tissue edges together. Resection is often performed when excess leaflet tissue is present. However, by providing a line configuration including a bridle point and multiple bridle lines, the need for the resection step can be eliminated. This can simplify the overall surgical procedure.

[0258] The soft tissue anchoring system may be a leaflet anchoring system. The soft body tissue may be a leaflet heart valve. The prosthetic line may be a prosthetic chordae line.

[0259] Each anchor member may be configured to pass through soft body tissue, and the bridle lines pass through the soft body tissue, and the bridle points may be configured to place each bridle line under tension as it passes through the tissue in a direction outward from the surface of the body tissue and when the bridle points are themselves under tension.

[0260] The bridle point may be a fixed bridle point such that the bridle lines cannot move relative to the bridle point at the connection. The bridle point may be a fixed knot, an eye plate, or other suitable fastener.

[0261] Alternatively, the bridle point may be a slidable bridle point so that the bridle lines can move relative to the bridle point at the connection. The bridle lines may be self-adjusting as described above. The bridle point may be a bridle knot with a single inter-line providing multiple bridle lines.

[0262] The artificial line may be connected to the bridle point and may be configured to apply tension to the bridle point, i.e., place the bridle point under tension.

[0263] The artificial line may form one of the bridle lines. The remaining bridle lines may be joined to the artificial line at bridle points located along the artificial line.

[0264] The bridle point is preferably positioned to provide each of a plurality of bridle lines on a first side of the bridle point with a single tension and / or artificial line located on a second side of the bridle point opposite the first side, such a configuration may provide a more consistent distribution of tension from the bridle point to each of the bridle lines.

[0265] The multiple bridle lines may be comprised of two bridle lines, in which case the bridle configuration may comprise a Y-shaped configuration.The multiple bridle lines may be comprised of three bridle lines, in which case the bridle configuration may comprise a trifurcated configuration.

[0266] Each anchor member may be a tubular cap member. The tubular cap members may be as described above, for example according to the first aspect.

[0267] Each anchor member may be an arm and / or an end cap. The arm and / or end cap may be in the form as described above, for example according to the second aspect.

[0268] The multiple anchor members may include a tubular cap member and arms and / or end caps.

[0269] Although the soft tissue anchor systems of the above-described aspects may have particular advantages and applications in the treatment of the heart, unless otherwise specified, their applications should not be considered limited to the treatment of soft cardiac tissue.

[0270] The soft tissue anchor system may be deployed via a suitable deployment device, preferably a catheter device. The deployment device may include an anchor deployment mechanism that holds and / or guides the soft tissue anchor system during deployment, e.g., during puncture of the body tissue and implantation of the arm portion(s) of the fabric body. The anchor deployment mechanism, or another part of the catheter device that holds the anchor deployment mechanism, may also act to remove the wire guide member(s) and / or pull the tension line to place the arm portion(s) and end cap(s) in their final position, e.g., with the arm portion(s) folded and the end cap(s) rotated to seat along the surface of the body tissue.

[0271] Thus, according to a fourth aspect of the present invention there is provided a catheter device for implanting a soft tissue anchor system in cardiac tissue comprising a housing section extending from a distal end of the catheter device along a length of the catheter device towards a proximal end of the catheter device, and a soft tissue anchor according to any of the previous aspects located within the housing section.

[0272] The catheter device of the fourth aspect may have one or more features corresponding to the features of the soft tissue anchor system of the previous aspect of the invention. Thus, the above description of the soft tissue anchor system of the previous aspect, including but not limited to all technical advantages and alternative embodiments, may be equally applicable to the catheter device of the fourth aspect.

[0273] The catheter device can include a wire guide member(s) for deploying the soft tissue anchor system from the housing section. If the soft tissue anchor system includes an end cap(s), the catheter device can include a wire guide member(s) that engages with the opening.

[0274] The wire guide member may include a shoulder and the housing section may include a stop configured to mate with the shoulder, thereby limiting distal movement of the wire guide member within the housing section.

[0275] By limiting the distal translation of the wire guide member, excessive tension in the wire guide member can be prevented during implantation of the soft tissue anchor system. For example, if the catheter device experiences curvature during delivery to the implantation site, the path of the wire guide member can be shortened or lengthened relative to the longitudinal axis of the catheter device. Thus, by limiting the distal translation of the wire guide member within the housing compartment, the final deployed length of the wire guide member can be better controlled. This can be particularly advantageous when multiple wire guide members are used to ensure that the wire guide members extend to the same final length to facilitate stable and symmetrical implantation of the end cap and / or arms into body tissue.

[0276] Thus, the wire guide member may include a shoulder (i.e., a first shoulder) for limiting the distal translation range of the wire guide member within the housing compartment and a corresponding portion / shoulder area (i.e., a second shoulder) configured to mate / engage with the end cap(s) for implanting the anchor system into body tissue.

[0277] According to a fifth aspect of the present invention, there is provided a catheter device for implanting a soft tissue anchor system in cardiac tissue, the soft tissue anchor system comprising: a housing section extending from a distal end of the catheter device along a length of the catheter device towards a proximal end of the catheter device; and a soft tissue anchor system comprising a plurality of anchor members; and a deployment system configured to simultaneously implant each of the anchor members into cardiac tissue, the deployment system comprising a plurality of wire guide members, each wire guide member comprising a guide portion located at a distal end thereof and configured to engage a respective anchor member, the deployment system configured to maintain coplanar alignment between the guide portions of the plurality of wire guide members during implantation of the anchor members.

[0278] When implanting a soft tissue anchor system comprising multiple anchor members into cardiac tissue, the inventors have recognized that it may be desirable to simultaneously implant each of the anchor members into the cardiac tissue. Simultaneous implantation of the anchor members can improve the stability of the implanted system because the anchor members can be deployed in the same, more controlled manner. Additionally, simultaneous implantation of the anchor members can reduce the complexity of the implantation procedure.

[0279] However, the inventors have further recognized that during delivery of the soft tissue anchor system to the heart via the catheter device, the delivery shaft of the catheter device may experience curvature due to the curvature of the blood vessel through which the catheter device traverses. Such curvature may result in various components of the catheter device having to traverse different distances depending on the radius of curvature the catheter device experiences during delivery to the heart. This may present a problem for the wire guide members used to embed the anchor members of the soft tissue anchor system into the heart tissue. If one wire guide member traverses a longer distance than the other wire guide members, the anchor members each deployed by the respective wire guide members may not embed simultaneously in the heart tissue because the wire guide members may become asymmetrically tensioned or positioned during delivery to the heart. This may affect the ability of the deployment system to simultaneously embed the anchor members into the heart tissue.

[0280] The deployment system is thus configured to maintain coplanar alignment between the guide portions of the multiple wire guide members during implantation of the anchor members. Thus, regardless of the curvatures that the wire guide members each independently undergo during delivery, the ends of the wire guide members that ultimately manipulate the anchor members during implantation remain aligned such that the anchor members are implanted simultaneously. By controlling the coplanar alignment of the guide portions of the wire guide members, any possible deflection of the wire guide members due to different curvatures can be restored prior to engagement with their respective anchor members.

[0281] By simultaneously implanted, it will be understood that the anchor member is implanted into the cardiac tissue at the same time that the anchor member itself is implanted into the cardiac tissue during the same action or movement.

[0282] Guide portions are understood to be coplanar when equivalent points or portions thereof, such as the ends of the wire guide member itself, lie substantially in the same plane as one another, said plane being defined perpendicular to the longitudinal axis of the catheter device or the wire guide member itself. Guide members may be considered to be coplanar when they coincide with the same plane or when they lie within the same plane with a tolerance of less than 0.5 mm, less than 1.0 mm or less than 1.5 mm.

[0283] Each wire guide member has a proximal end and a distal end. The portion located at the distal end is a guide portion configured to engage a respective anchor member, as described above. Each wire guide member may also include a control portion extending from the guide portion and located toward and / or at the proximal end.

[0284] The guide portion may include a tip configured to pierce cardiac tissue during implantation. Alternatively, the guide portion may be configured to be received by an opening in the anchor member such that the guide portion provides a driving force to the anchor member that itself pierces the cardiac tissue.

[0285] The control portion may be thicker, i.e., have a larger diameter, than the guide portion. The control portion generally extends from the housing of the catheter device through the delivery shaft of the catheter device. The control portion may extend to the delivery handle of the catheter device, which is located at the proximal end of the catheter device.

[0286] The guide portion may have a diameter (i.e., outer diameter) of about 0.3 mm. The control portion may have a diameter (i.e., outer diameter) of about 0.5 mm.

[0287] Each wire guide member may include a bulge.

[0288] The bulge portion is preferably located between the guide portion and the control portion and has a larger diameter than both the guide portion and the control portion.

[0289] The bulge may have a diameter (ie, outer diameter) of about 0.8 mm. The bulge may have a diameter of 0.6 mm to 0.9 mm.

[0290] The bulge may have a length approximately equal to its diameter. The bulge may have a length of about 0.8 mm.

[0291] The bulge has a bulbous shape, preferably including a central portion that defines a maximum diameter of the bulge, and two tapered / transition portions located on either side of the central portion.

[0292] Each wire guide member may be movable between a first configuration and a second configuration, where in the first configuration the bulge is configured to engage a first obstacle configured to limit translation of the wire guide member in a proximal direction and where in the second configuration the wire guide member is configured to engage a respective anchor member.

[0293] By limiting the translation of the wire guide member in the proximal direction, the wire guide member is prevented from being asymmetrically retracted into the delivery shaft of the catheter device during deployment (e.g., due to tension stretching experienced during delivery due to curvature). The first obstacle also provides a reference point from which the coplanar alignment of the wire guide members can be restored or maintained during delivery of the catheter device to the heart. For example, the guide portions of the wire guide members can each be coplanarly aligned with one another when the bulge abuts the first obstacle. The coplanar alignment of the guide portions of the wire guide members can be restored by automatically or manually moving each of the wire guide members to the first configuration. Thus, the first obstacles themselves are, by definition, in coplanar alignment with one another.

[0294] The first obstruction can define a channel or groove through which the control portion can pass but not the guide portion.

[0295] The first obstruction may be an abutment located at a proximal portion of the housing section.

[0296] By locating the first obstruction proximally of the housing, the point at which coplanar alignment may be maintained or restored is located distal to any portion of the wire guide member that may undergo bending during delivery.

[0297] The guide portions of the plurality of wire guide members are configured to be aligned in the same plane when the bulging portions abut against the first obstacle.

[0298] The abutment portion may be complementary in shape to the bulge portion such that the bulge portion is configured to mate with the abutment portion in the first configuration.

[0299] In the second configuration, the bulge may be configured to abut a complementary portion of the anchor member.

[0300] The complementary portion may be a tapered / transition portion of the bulge.

[0301] Thus, the bulge may provide a surface or portion over which the wire guide member may provide a driving force to the anchor member.

[0302] The bulge itself may function as a shoulder configured to engage a flared inlet of a tubular cap member or end cap, as described in the first and second aspects and any associated aspects, respectively.

[0303] Alternatively, in the second configuration, the bulge portion may be configured to abut a second abutment portion located at a distal portion of the housing section, the second abutment portion configured to limit translation of the wire guide member in the distal direction.

[0304] By providing a second abutment at the distal portion of the housing section, excessive tension on the wire guide member during implantation of the soft tissue anchor system can be prevented.

[0305] The second abutment portion may include a channel or groove through which the control section and guide portion may pass, but not the bulge.

[0306] In such an arrangement, the bulge may be located within the control portion rather than between the control portion and the guide portion.

[0307] The wire guide member may include a shoulder extending between the control and the guide portion. The shoulder can define an angled transition between the control and the guide portion. The shoulder can be configured to abut or engage a complementary portion of the anchor member, thereby providing a driving force to the anchor member during implantation.

[0308] The deployment system can be configured to passively maintain coplanar alignment between the guide portions by manually restoring the guide portions to fall within a common plane. For example, a user can pull on each of the wire guide members following delivery of the catheter device to the cardiac tissue, with each of the first obstacles providing a surface for restoring the coplanar alignment.

[0309] Alternatively, the deployment system can be configured to actively maintain coplanar alignment between the guide portions by automatically restoring the guide portions to lie in a common plane.

[0310] The deployment system can include a spring device. Each wire guide member can be connected to the spring device. The spring device can be configured to automatically restore coplanar alignment between the guide portions of the plurality of wire guide members during delivery of the catheter device to the heart. The spring device can be an example of a device configured to actively maintain coplanar alignment between the guide portions.

[0311] The spring device can provide one or more control inputs to the multiple wire guide members.

[0312] Preferably, the spring device is configured to bias each wire guide member into the first configuration.

[0313] By providing a spring device configured to bias each wire guide member into the first configuration, the deployment system can automatically restore coplanar alignment between the guide portions of the wire guide members during delivery of the catheter device to the heart.

[0314] The spring arrangement may comprise a plurality of spring members each selectively connected to a respective wire guide member, and each spring member may be configured to provide a restoring force to a respective wire guide member.

[0315] The spring device can be configured to adjust the relative tension between each of the wire guide members to maintain coplanar alignment of the guide members despite any deflection or misalignment of the control during delivery of the catheter device.

[0316] The spring device may include a tension adjustment mechanism for relieving tension in each wire guide member and a tension restorer for relieving or balancing the relative tension between each wire guide member. The tension adjustment mechanism may relieve tension experienced by any wire guide member that is under tension due to bending or curvature, which may be experienced as a pulling force due to a first obstacle preventing the wire guide member from being retracted into the delivery shaft. The tension restorer may relieve tension by adjusting the lateral force on each of the wire guide members, i.e., the force applied in a direction extending perpendicular to the longitudinal extent of the wires in the spring device. Thus, the tension restorer may relieve any tension by the bow tension principle, where a change in the lateral displacement of the wires increases or decreases the longitudinal tension of the wire guide members.

[0317] The spring device can be located within the delivery handle of the catheter device.

[0318] The multiple wire guide members can be configured to be translated simultaneously by a single control input. The single control input can be configured to selectively engage the multiple wire guide members. Once coplanar alignment of the wire guide members is restored (or provided that the coplanar alignment of the wire guide members is maintained) during delivery of the catheter device, equal and / or symmetrical longitudinal translation results in equal and therefore simultaneous manipulation of the wire guide members to simultaneously implant the anchor members.

[0319] The single control input can include a first gear set configured to transmit a translation input and a second gear set configured to translate each of the wire guide members. The first gear set is complementary to and selectively engageable with the second gear set. Prior to implantation, when the catheter device is delivered to the cardiac tissue, the gears preferably engage with each other. The first gear set is simultaneously operable such that each of the wire guide members are simultaneously translated by the single control input.

[0320] The spring device can be configured to be selectively disconnected from the plurality of wire guide members prior to controlling and / or engaging a single control input. The spring device may be configured to be selectively reconnected, for example, prior to retracting the catheter device.

[0321] The spring arrangement may be provided as part of a single control input.

[0322] Each anchor member may be a tubular cap member of the soft tissue anchor system.

[0323] The soft tissue anchor system may be the soft tissue anchor system according to the first aspect. Thus, the catheter device of the fifth aspect may have one or more features corresponding to the features of the soft tissue anchor system of the first and other related aspects of the invention.

[0324] Each anchor member may be an end cap of a soft tissue anchor system.

[0325] The soft tissue anchor system may be the soft tissue anchor system according to the second aspect. Thus, the catheter device of the fifth aspect may have one or more features corresponding to the features of the soft tissue anchor system of the second and other related aspects of the present invention.

[0326] The soft tissue anchor system may be the soft tissue anchor system according to the third aspect. Thus, the catheter device of the fifth aspect may have one or more features corresponding to the features of the soft tissue anchor system of the third aspect and other related aspects of the present invention.

[0327] Thus, the above description of the soft tissue anchor system of the previous aspect, including but not limited to all technical advantages and alternative embodiments, may be equally applicable to the catheter device of the fifth aspect.

[0328] The following features may be characteristic of the catheter device of the fourth and / or fifth aspect of the invention.

[0329] The catheter device may include an anchor deployment mechanism that holds and / or guides the soft tissue anchor system during deployment, e.g., during puncture of the body tissue and implantation of the arm(s) of the fabric body. The anchor deployment mechanism, or another portion of the catheter device that holds the anchor deployment mechanism, may also act to remove the wire guide member(s) and / or pull the tension line to place the arm(s) and / or end cap(s) in their final position, e.g., with the arm(s) folded and / or the end cap(s) rotated to seat along the surface of the body tissue.

[0330] The soft tissue anchor system can be held within a curtain or sheath within the catheter device. The sheath can be configured to flex or crumple during deployment to aid in the deployment of the soft tissue anchor system from the catheter device. The sheath can reduce friction between the soft tissue anchor system and the catheter device during deployment of the soft tissue anchor system from the catheter device.

[0331] The sheath may be a thin tubular sheath.

[0332] If the flexible tissue anchor system comprises a fabric body, the sheath can be used to hold the fabric body. If the flexible tissue anchor system comprises a tubular cap member / end cap, the member / cap can be held outside or within the sheath.

[0333] The sheath may be housed within the anchor deployment mechanism.

[0334] The sheath may be attached or secured to the anchor deployment mechanism so that it does not become dislodged from the catheter device during deployment of the soft tissue anchor system from the catheter device.

[0335] The anchor deployment mechanism can include an anchor deployment tube that holds and guides part(s) of the soft tissue anchor system, such as the arm(s) and / or end cap(s), and a wire guide member(s).

[0336] When multiple arms, such as a U-shaped fabric body and two arms, are used, the anchor deployment tube may comprise a pair of tubes, one for each arm and its respective wire guide member, with the joints between the tubes allowing a connecting bridge of fabric from the base between the arms to span between the tubes. For example, there may be a slot along the tube for the connecting bridge to slide over.

[0337] Similarly, if a soft tissue anchor system is used that includes two tubular cap members / T-bar anchors, each connected via an interline (e.g., a single line extending between the central portions of each of the two tubular cap members joined to the artificial line at the central portion of the line, or, e.g., two lines each connected to the central portions of the respective tubular cap members and fixed distally to each other relative to their ends), the anchor deployment tubes can similarly include a pair of tubes, one for each tubular cap member (i.e., T-bar anchor) and its respective wire guide member. There can also be joints between the tubes that allow the interline / fixation between the two lines between the two T-bar anchors to span between the tubes. For example, there may be slots along the tabs for the interline / fixation to slide.

[0338] The sheath may be retained within the anchor deployment tube and may extend to a tube that houses the end cap / tubular cap member.

[0339] The soft tissue anchor system can be a leaflet anchor deployed via a catheter device. One possible catheter device is a device configured to repair the heart by implanting an artificial chord line, whereby the soft tissue anchor system acts as a leaflet anchor for joining the artificial chord line to the leaflet of the heart. In one example, the catheter device includes 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, a leaflet anchor (including a soft tissue anchor system) for placement at the leaflet of the heart valve, the leaflet anchor being arranged to couple to the artificial chord line, and a leaflet anchor deployment mechanism for deploying and attaching the leaflet anchor to the leaflet of the heart.

[0340] The leaflet anchor deployment mechanism can include a mechanical gripper device for gripping the leaflets of the heart valve and a leaflet anchor tube for housing the leaflet anchor prior to deployment within body tissue, the gripper device and leaflet anchor being configured such that, in use, when the gripper device grips the leaflet, a soft tissue anchor system can be pushed out of the leaflet anchor tube to puncture the leaflet and deploy the anchor as described elsewhere herein, thereby securing the fabric body within the leaflet.

[0341] The mechanical gripper device can include a gripper arm rotatably coupled to the body of the catheter device such that the gripper arm can rotate relative to the catheter device to move an outer end of the gripper arm outwardly from the body of the catheter device.

[0342] The gripper arm can include a slot formed in a base of the gripper arm, and the gripper arm can be rotatably coupled to the body of the catheter device via the slot such that the gripper arm is configured to translate outwardly from the body, this translation being included / in addition to the rotational movement of the gripper arm described above.

[0343] By allowing the gripper arms to translate outwardly from the body, space between the body of the catheter device and the gripper arms can be provided and adjusted, which can improve the gripping of the grasped leaflet. For example, leaflets can have a thickness of 1-3 mm in humans, therefore, allowing the gripper arms to translate outwardly from the body of the catheter device to accommodate leaflets of various thicknesses can improve the contact of the leaflet between the body of the catheter device and the gripper arms.

[0344] Additionally, by providing a means by which the gripper arms can translate outwardly from the body of the catheter device, the entire gripper arm face may ungrip the gripped leaflet in one translational motion, such that the leaflet / soft body tissue may then be more smoothly disengaged by the gripper arms before being rotated to completely release the leaflet from between the body of the catheter device and the gripper arms.

[0345] The leaflet anchor tube may be formed within the body of the catheter device, and the leaflet anchor may thus be configured to be deployed from the body of the catheter device towards the gripper arms that grip the leaflet.

[0346] The gripper arm can include a plurality of serrations configured to increase a contact area between the leaflet and the gripper arm. The serrations can be located on a first portion of the gripper arm configured to face the opening of the leaflet anchor tube and on a second portion of the gripper arm configured to face the body of the catheter device.

[0347] By providing serrations surrounding the gripper arms in this manner, the gripper arms may improve the gripping contact between themselves and the valve leaflet. For example, the serrations may effectively circumferentially surround the face of the gripper arms that is configured to contact the valve leaflet. Thus, the leaflet may be better supported by the gripper arms.

[0348] The body can also include a plurality of serrations formed on a surface configured to face the gripper arms. Providing serrations on both the gripper arms and the body of the catheter device can further enhance the force with which the gripper arms grip the valve leaflets.

[0349] The serrations are preferably blunted to minimize trauma to the leaflets when gripped. The serrations may be uneven and / or uniformly distributed undulations in the surface of the gripper arms and / or the body of the catheter device that increase the surface area of ​​that body, e.g., compared to a flat / planar surface.

[0350] The gripper arms can include an interior space configured to receive the arm portion(s) and / or end cap(s) and wire guide member(s) deployed from a leaflet anchor tube formed within the body of the catheter device. The interior space can open to a face of the gripper arms configured to contact the leaflet and can be bounded by a sidewall of the gripper arms.

[0351] The interior space can facilitate full extension of the wire guide member(s) so that the arm(s) and / or end cap(s) pass completely through the valve leaflets and are thus securely embedded in the soft body tissue.

[0352] The interior space may include a first interior space configured to receive a first wire guide member and a second interior space configured to receive a second wire guide member. Openings of the first interior space and the second interior space may be separated by a gripper configured to contact the leaflet. Providing a gripper may increase a surface area of ​​the leaflet that contacts the gripper arms, thus increasing stability of the leaflet during implantation of the multiple arms and / or end caps within the leaflet.

[0353] In an exemplary embodiment, the leaflet anchor tube is positioned to implant the leaflet anchor into the leaflet of a heart valve, which may be a mitral or tricuspid leaflet, by puncturing the leaflet from the atrial side of the leaflet.

[0354] The device allows for easy gripping of the leaflets and firm attachment of the new chordae to the leaflets without the need for complex procedures involving the use of vacuum and sutures as in WO 2008 / 101113. The mechanical gripper device can be opened and closed several times as necessary to release and re-engage the leaflets until the desired position is reached with the anchor in place.

[0355] The prior catheter devices of WO 2016 / 042022 and WO 2020 / 109596 generally attempted to implant leaflet anchors in the leaflets of a heart valve by puncturing the leaflet from the ventricular side of the leaflet rather than the atrial side of the leaflet. However, the applicant has recognized that a catheter device that implants a leaflet anchor from the atrial side of the leaflet offers several advantages that may not be present if the leaflet anchor is implanted from the ventricular side of the leaflet of a heart valve.

[0356] When implanted from the ventricular side of the leaflet, the leaflet anchor may need to be positioned towards the edge of the leaflet to provide adequate support to the flail leaflet In contrast, when implanted from the atrial side of the leaflet, the leaflet anchor may provide adequate support to the leaflet edge if the leaflet anchor is implanted towards the leaflet edge or towards the leaflet annulus.

[0357] The selected location of implantation of the leaflet anchor may depend on several factors and may be patient specific: Implanting the leaflet anchor on the atrial side of the leaflet may provide the surgeon with greater flexibility in choosing where to implant the leaflet anchor, i.e., toward the edge of the leaflet, toward the annulus of the leaflet, or between the leaflets.

[0358] Tissue of the leaflet closer to the annulus, rather than toward the leaflet edge, may be less susceptible to trauma associated with implantation of a leaflet anchor. Tissue toward the leaflet annulus may be thicker than tissue toward the leaflet edge, for example. Tissue toward the leaflet annulus may be better able to withstand tension associated with the prosthetic chordae line during the cardiac cycle if the line is in tension.

[0359] By implanting the leaflet anchor from the atrial side, it may be possible for the leaflet anchor to be implanted closer towards the annulus of the heart leaflet while still providing sufficient support to the edges of the leaflet.

[0360] When artificial chordae lines are used to prevent leaflet regurgitation (i.e. mitral or tricuspid regurgitation), the lines are generally fixed at two ends, one end located at / in the papillary muscle of the heart and the other end located at the anchor of the leaflet. Thus, when the leaflet anchor (soft tissue anchor system) is implanted in the leaflet from the ventricular side, the line extends to the papillary muscle without providing any support to the leaflet edge, i.e. the fluttering edge of the leaflet. However, when implanted in the leaflet from the atrial side, the line extends along the atrial surface of the leaflet and can extend beyond the leaflet edge before descending into the ventricle to its implantation location in the papillary muscle. In this way, the line can support the fluttering edge of the leaflet by the anchor implanted towards the leaflet annulus. This can also better reproduce the action of the chordae tendineae located towards the edge of the leaflet of the heart valve.

[0361] The leaflet anchor (soft tissue anchor system) may be configured to be deployed such that the prosthetic chordae lines contact the atrial side of the heart valve leaflet between the leaflet anchor and the edge of the heart valve leaflet.

[0362] It will be appreciated that if the leaflet anchor is implanted from the atrial side, the artificial chordae line can provide support to the fluttering edge when implanted on the atrial side of the leaflet, given that when the line is implanted it passes over the edge of the leaflet and down through the leaflet valve from the atrial side to the ventricular side, which can be particularly beneficial when treating fluttering leaflets.

[0363] The catheter devices prior to WO 2016 / 042022 and WO 2020 / 109596 may generally require precise implantation of leaflet anchors (soft tissue anchor systems) into the leaflets to provide adequate support to the leaflet edges. Because the leaflet anchors do not provide any additional support to the leaflet edges beyond their own implantation, the anchor's implantation location determines how much support is provided to the leaflet edges. Thus, more precise implantation of the leaflet anchors may be required to ensure adequate support to the leaflet edges.

[0364] However, due to the contact of the artificial chordae lines with the edge of the leaflet when the leaflet anchor is implanted on the atrial side of the leaflet, the implantation location of the leaflet anchor of the present invention does not need to be as precise because additional support is provided to the edge of the leaflet whether the leaflet anchor is implanted toward the edge of the leaflet or toward the atrial annulus of the leaflet. This may result in more efficient implantation of the leaflet anchor because leaflet movement during the cardiac cycle, which may change the implantation location of the leaflet anchor, has less adverse effect on the overall support provided by the leaflet anchor.

[0365] The artificial chordae lines may have a varying cross-sectional area. The artificial chordae lines may have a first cross-sectional area at a distal end of the leaflet anchor and / or may be configured to be located at / within the papillary muscle. The artificial chordae lines may have a second cross-sectional area at an end proximal to and / or attached to the leaflet anchor (soft tissue anchor system).

[0366] The first cross-sectional area and the second cross-sectional area may be different. The second cross-sectional area may be a rectangular cross-sectional area. The second cross-sectional area may be an elliptical cross-sectional area. The major axis of the second cross-sectional area may be configured to be parallel to the atrial surface of the leaflet anchor. The second cross-sectional area may be larger than the first cross-sectional area. The first cross-sectional area may be circular.

[0367] By providing the artificial chordae line with a second cross-sectional area as described above, the surface area of ​​the artificial line in contact with the atrial side of the valve leaflet can be increased, and therefore the artificial chordae line can provide a greater degree of support to the flail valve leaflet when implanted.

[0368] The artificial chordae line may include multiple sutures. Multiple sutures can increase the contact area between the artificial chordae line and the atrial side of the leaflet, such that a greater degree of support is provided to the flail leaflet by the artificial chordae line. Additionally, redundancy is introduced such that if one of the multiple sutures fails, one or more of the multiple sutures can still be successfully implanted.

[0369] The catheter device includes a housing section extending from a distal end to a proximal end of the catheter device. The distal-most end of the catheter device may be where the artificial cord line is typically implanted, while the proximal end may be located at the opposite end of the catheter device. The catheter device may generally be inserted into the body in a direction aligned with the extension direction of the catheter device from the proximal end to the distal end.

[0370] The leaflet anchor (soft tissue anchor system) may be configured to be deployed by pushing it out of an opening in the end of the leaflet anchor tube, the opening being configured to contact the atrial side of the heart valve leaflet during deployment.

[0371] Contacting the opening of the leaflet anchor tube with the atrial side of the heart leaflet during deployment can facilitate implantation of the leaflet anchor from the atrial side of the leaflet, for example, contacting the opening with the atrial side can ensure proper placement, localization and deployment of the anchor as it transitions from its resiliently folded configuration to its deployed configuration.

[0372] The leaflet anchor (soft tissue anchor system) may be configured to be pushed out of the leaflet anchor deployment mechanism from the proximal end of the catheter device towards the distal end of the catheter device.

[0373] The catheter device can include a straight rod for deploying the leaflet anchor. The straight rod can be configured to push the leaflet anchor out of the leaflet anchor deployment mechanism. The straight rod can be the wire guide member(s).

[0374] Previous devices disclosed in WO 2016 / 042022 and WO 2020 / 109596 each taught a U-shaped rod to push the leaflet anchor out of the leaflet anchor deployment mechanism. The U-shaped rod was necessary in each of these prior art devices due to the leaflet anchor being deployed on the ventricular side of the leaflet, i.e., underneath the leaflet. However, in the device of the present invention, the leaflet anchor (soft tissue anchor system) can be configured to be embedded on the atrial side of the leaflet. Thus, the leaflet is approached from above, and thus the leaflet anchor is deployed distally of the catheter device. In other words, the leaflet anchor is deployed in the same direction as the catheter device approaches the leaflet of the heart.

[0375] Thus, a linear rod can be used. A linear rod, being straight, may generally be easier to manufacture. A linear rod may also be easier to place within a catheter device along with any other number of wires, rods, etc. for manipulating other components located at the distal end of the catheter device. Thus, a linear rod may facilitate the manufacture of a catheter device, especially when compared to previous U-shaped rod designs. The wire guide member(s) may function as a linear rod.

[0376] The catheter device can generally approach the implantation location from the atrial side of the heart rather than the ventricular side of the heart due to known techniques for inserting the catheter device into the heart. That is, upon approach, the distal end of the catheter device is directed toward the atrial side of the leaflets of the heart. Thus, to facilitate deployment of the leaflet anchor on the atrial side of the leaflet (whose surface faces toward the proximal end of the catheter device), the leaflet anchor can be pushed out of the leaflet anchor deployment mechanism from the proximal end of the catheter device toward the distal end of the catheter device.

[0377] The leaflet anchor tube may be formed within the body of the catheter device. The leaflet anchor tube may not be formed within the gripper device. The openings in the leaflet anchor tube may be located on a surface of the body of the catheter device such that the leaflet anchor may be deployed from the body of the catheter device. The openings may be located such that the leaflet anchor may be deployed from the circumferential and / or lateral surfaces of the catheter device.

[0378] As also described above, the gripper arms can include an interior space configured to receive the arm portion(s) and / or end cap(s) and wire guide member(s) deployed from a leaflet anchor tube formed within the body of the catheter device. The interior space may open to a face of the gripper arms configured to contact the leaflet and be bounded by a sidewall of the gripper arms.

[0379] The leaflet anchor tube may extend generally along the length of the body of the catheter device, and may also have a component that extends along a radius of the catheter device such that the leaflet anchors may be deployed from locations on the circumference of the catheter device.

[0380] Applicants have recognized that forming the leaflet anchor tubes within the body of the catheter device, rather than within a gripper device, may provide a number of previously unknown advantages.

[0381] WO 2020 / 109596 and WO 2016 / 042022 contemplate catheter devices with gripper arms, in which a leaflet anchor tube is formed within the gripper arm of the device. Thus, the gripper arm is longer than the leaflet anchor of the prior art device so that the leaflet anchor tube can be accommodated within the gripper arm. The extended length of the gripper arm to accommodate the leaflet anchor and the deployment location from the gripper arm can effectively reduce the range of depth at which the leaflet anchor can be embedded into the leaflet.

[0382] When the leaflet anchor tube is formed within the body of the catheter device, the gripper arms can be shorter in length than the leaflet anchor when in the folded configuration. This is possible because the leaflet anchor (soft tissue anchor system) is not housed within the gripper arms. A shorter gripper arm can grip the leaflet more tightly than a longer gripper arm when the same force is applied to the gripper arm. When the leaflet anchor is deployed within the leaflet at a location approximately adjacent to the distal end of the gripper arm, the moment of force associated with deployment of the anchor can be reduced when using a shorter gripper arm. Thus, the leaflet can be held more firmly in place during implantation of the anchor.

[0383] Additionally or alternatively, the length of the leaflet anchor may not be constrained by the length of the gripper arms. Thus, when the leaflet anchor tube is formed within the body of the catheter device, a leaflet anchor that is longer than the length of the gripper arms may be utilized. A longer leaflet anchor may be able to secure and / or support a larger portion of the leaflets of the heart when implanted compared to a shorter anchor.

[0384] The gripper arm can be positioned to mate with an opening in the leaflet anchor tube. The leaflet anchor tube can be formed in the body such that a surface of the gripper arm mates with the opening in the leaflet anchor tube when the gripper arm is held against the body of the catheter. The opening in the leaflet anchor tube can mate with a distal end of the gripper arm. The opening in the leaflet anchor tube can mate with a surface of the gripper arm located toward the distal end of the gripper arm.

[0385] By positioning the gripper arms to match the openings of the leaflet anchor tube, the leaflet anchor may be more reliably deployed at a desired location within the heart. For example, when the gripper arms grip the leaflet, the leaflet may be held between the gripper arms and the leaflet anchor tube, such that the leaflet anchor (soft tissue anchor system) may be deployed within the leaflet at the gripped location. The gripper arms positioned against the proximal side of the leaflet may provide resistance to the leaflet as the anchor is deployed, such that the leaflet is properly restrained during deployment.

[0386] Alternatively, the leaflet anchor tube may be housed within the gripper arm, with the opening of the leaflet anchor tube being at the end of the gripper arm and facing towards the distal end of the catheter.

[0387] It will be appreciated that in this configuration, the gripper arm may be hinged towards the proximal end of the catheter device with the distal end of the gripper arm facing towards the distal end of the catheter device. Thus, in contrast to the gripper arms disclosed in WO 2016 / 042022 and WO 2020 / 109596, the gripper arm may be oriented such that the leaflet anchor (soft tissue anchor system) is configured to be deployed distally of the catheter rather than proximally.

[0388] The opening of the leaflet anchor tube located in the gripper arm may be configured to mate with a complementary surface of the body of the catheter device. In this manner, when the leaflet is gripped by the gripper arm, the body of the catheter device can provide resistance to the leaflet as the anchor (soft tissue anchor system) is deployed, such that the leaflet is properly restrained during deployment.

[0389] The gripper arms can be configured to grip the leaflet such that the leaflet anchor tube is positioned to embed the leaflet anchor toward the annulus of the leaflet The gripper arms can be configured in this manner when the leaflet anchor tube is formed within the body or gripper arms of the catheter device.

[0390] For example, the gripper arms can grip the leaflet such that the opening of the leaflet anchor tube is located toward the annulus of the leaflet. When the leaflet anchor tube is positioned within the body of the catheter device, the gripper arms can grip the leaflet from the ventricular side such that the distal end of the gripper arm contacts the leaflet at or toward the ventricular annulus of the leaflet and the opening of the leaflet anchor tube is located at or toward the annulus of the leaflet on the atrial side. When the leaflet anchor tube is positioned on the gripper arms, the gripper arms can grip the leaflet from the atrial side such that the distal end of the gripper arm contacts the leaflet at or toward the atrial annulus of the leaflet and the opening of the leaflet anchor tube is located at or toward the atrial annulus of the leaflet.

[0391] The gripper arms may additionally or alternatively be configured to grip the leaflet such that the leaflet anchor tube is positioned to embed the leaflet anchor toward an edge of the leaflet The gripper arms may be configured in this manner when the leaflet anchor tube is formed within the body or gripper arms of the catheter device.

[0392] The catheter device may include a hinge mechanism for the gripper arms that is integrally formed with the material of the body and rotates outwardly from the body by elastic deformation of the material.

[0393] A single wire can be provided to actuate the gripper arm by bending the hinge mechanism to rotate the end of the gripper arm outwardly from the body, and when no force is applied to the wire, the gripper arm resiliently returns to its rest position.

[0394] The gripper arms can be actuated using a single wire or multiple wires. Advantages can be obtained if the hinge mechanism for the gripper arms is integrally formed with the material of the body and rotates outwardly from the body by elastic deformation of the material. The gripper arms and hinge mechanism may be integrally formed with the material of the body. Alternatively, the gripper arms may include separately formed arm sections, such as milled or laser cut pieces, with the separate arm sections attached to the hinge mechanism of the body, for example by gluing or welding.

[0395] In some examples, the body of the catheter device may be formed from an elastic metal such as Nitinol, and the hinge is provided by an elastic joint formed in the elastic metal. In that case, a single wire may be used to elastically deform the gripper arm by bending the elastic joint with the body to rotate the end of the gripper arm outward from the body, and when the force on the wire is removed, the gripper arm elastically returns to its rest position. The advantage of this is that the elastic force of the gripper arm can hold the gripper arm in place against the body of the catheter device when the force is released from the wire, without the need to pull a separate wire to firmly hold the grip on the valve leaflet. However, a second wire may be implemented as a backup if necessary.

[0396] In other examples, the body of the catheter device may be formed from a composite material such as carbon or glass reinforced PEEK. The gripper arm may then be joined to the body of the catheter device using a pin joint, with the pin forming the axis of rotation of the gripper arm. The pin joints referred to herein may be revolute or hinge joints, i.e., with features that mate with a pin or cylindrical member joining the members, with the pin forming the axis of rotation of the joint.

[0397] Alternatively, or in addition, the gripper arms can be heat set in a "super closed" configuration, which allows the gripper arms to grip tissue towards the body of the device.

[0398] To form the gripper arms and hinges integrally with the body of the catheter device, the body of the catheter may include an outer tube, with the gripper arms formed as articulation sections of the outer tube. Some form of slits and / or patterns can be formed in the tube to provide a weakened hinge section that allows bending of the gripper arms without plastic deformation.

[0399] In an alternative configuration, a hinged gripper arm can be used. In that case, the gripper arm may be milled and actuation in that case can be done with a spring to close and a wire to open, or vice versa, or with two wires (one to open and one to close). A pulley cut into the device can be used to redirect the pulling force from the pull wire.

[0400] The gripping surfaces of the gripper arms can be configured to frictionally hold the leaflets, for example, the gripping surfaces can use a material with a high coefficient of friction and / or the gripping surfaces can have a texture or surface profile to increase friction, such as a raised or sawtooth profile.

[0401] The housing section may be a two-piece housing section. The catheter device may comprise a two-piece 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 two-piece housing section comprising a distal section at the distal end of the catheter device and a proximal section located proximal to the distal section, the leaflet anchor deployment mechanism being at the proximal section of the housing section, a papilla anchor deployment mechanism at the distal section of the housing section for deploying a papilla anchor for attachment to a papillary muscle, the papilla anchor deployment mechanism being configured to deploy the papilla anchor by moving the papilla anchor distally outward relative to the distal section, and a flexible joint disposed between the proximal and distal sections of the two-piece housing section, the flexible joint allowing a centerline of the distal section to be tilted relative to a centerline of the proximal section.

[0402] The two-part housing section may be configured to be simultaneously positioned between the papillary muscle and the leaflets of the heart valve during use of the catheter device.

[0403] The gripper arm may be provided at a proximal portion of the two-part housing section and may be rotatably coupled to the catheter device. The gripper arm may be rotatably coupled via any of the mechanisms described above.

[0404] The two-part housing section may be formed of two tubular sections of any suitable material, i.e. medically suitable material. Stainless steel or Nitinol may be used. Alternatively, composite materials such as carbon fiber or glass fiber reinforced PEEK may be used. The catheter device may be formed by a combination of such materials, the materials of the different parts of the device being selected according to the required properties of those parts. Materials that allow ultrasound to pass through and at the same time have sufficient strength are preferred, carbon reinforced PEEK meets these requirements well and also allows injection molding of the components, lowering manufacturing costs. Fiber reinforced plastics are usually not visible on x-rays, therefore radiopaque markers strategically placed within all components can be used to determine the position and orientation of the device component(s) relative to each other on x-rays as complementary information to ultrasound imaging.

[0405] The flexible joint can include a hinge element, for example, a distal portion of a two-part housing section is coupled to a proximal portion via a pivot mechanism or via an elastically deformable element. For example, the two parts of the housing section can be composite or metal parts coupled together by a hinge element.

[0406] The nipple anchor can be housed within the distal portion of the housing section prior to its deployment. The nipple anchor can have a cross-section similar to the distal portion of the housing section. For example, when the anchor is held within the distal portion, both may have a tubular configuration. As described above, the anchor can have a folded configuration and a deployed configuration that allows the pin of the anchor to form a hook-like shape within the body tissue during deployment of the nipple anchor. The nipple anchor deployment mechanism may take a form similar to that of WO2016 / 042022 or WO2020 / 109596.

[0407] In one example, the nipple anchor deployment mechanism includes a first wire or rod for pushing the nipple anchor distally against 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 to disengage the nipple anchor from the catheter device after implantation into body tissue, i.e., tissue of the papillary muscle and / or tissue adjacent to the papillary muscle.

[0408] The nipple anchor may have a sore line attached thereto and may include a locking mechanism, such as a locking ring as in WO 2016 / 042022 or WO 2020 / 109596, for clamping the sore line when no force is applied to the locking mechanism. The locking ring may be capable of elastically deforming to adjust the length of the sore line to release the line from the locking mechanism. The nipple anchor deployment mechanism may include a locking ring holder for holding the locking ring in its elastically deformed position, the nipple anchor deployment mechanism being configured to selectively withdraw the locking ring holder from the locking ring, such that the sore line can be locked in place after deployment of the nipple anchor and any necessary adjustment of the length of the sore line.

[0409] The leaflet anchor deployment mechanism can allow for retraction and repositioning of the leaflet anchor (soft tissue anchor system) after the anchor has been deployed within the leaflet via an ejector unit having a gripping device having a first configuration arranged to allow deployment of the leaflet anchor into the leaflet without disengaging the leaflet anchor from the ejector unit, and a second configuration in which the leaflet anchor is reversibly released from the ejector unit, where in the first configuration the gripping device of the ejector unit grips a proximal end of the leaflet anchor while a distal end of the leaflet anchor is allowed to be embedded into the leaflet unhindered by the gripping device, and in the second configuration the gripping device of the ejector unit is disengaged from the leaflet anchor.

[0410] The leaflet anchor (soft tissue anchor system) can be retracted into the retraction tube / catheter by pulling on the chordae tendineae so that the leaflet anchor collapses into the retraction tube. The retraction tube may be placed over chordae tendineae that are only attached to the leaflet (with the device removed) or over leaflet anchors that are positioned in a poor location (partially engaged, free-floating, tangled, etc.). The retraction tube may be a deflectable shaft with or without a flexible section at the tip (which allows the tip to find the leaflet anchor base and allows retraction). Alternatively, the retraction shaft may be a flexible tube positioned to engage the base of the leaflet anchor.

[0411] According to a sixth aspect of the present invention there is provided a method of implanting a soft tissue anchor system according to the first aspect comprising engaging a tubular cap member using a wire guide member, pushing the tubular cap member through the body tissue using the wire guide member, withdrawing the wire guide member and applying tension to the line as it passes through the tissue in a direction outward from its surface such that the tubular cap member seats in the soft body tissue.

[0412] The method of the sixth aspect of the invention may have one or more features corresponding to the features of the soft tissue anchor system of the first aspect of the invention. Thus, the above description of the soft tissue anchor system of the first aspect, including but not limited to all technical advantages and alternative embodiments, may be equally applicable to the method of the sixth aspect.

[0413] According to a seventh aspect of the present invention there is provided a method of manufacturing a soft tissue anchor system according to the first aspect, the method comprising creating a tubular cap member and fixing a line to the tubular cap member with the line extending from a central portion of the tubular cap member.

[0414] Making the tubular cap member may include machining an outer tubular member, machining an inner tubular member, securing a line between the outer tubular member and the inner tubular member, and fitting the inner tubular member to the outer tubular member.

[0415] Alternatively, where the tubular cap member is a single monolithic component, fabricating the tubular cap member may include laser cutting or machining the tubular cap member from a single piece of Nitinol or stainless steel.

[0416] The method of the seventh aspect of the invention may have one or more features corresponding to the features of the soft tissue anchor system of the first aspect of the invention. Thus, the above description of the soft tissue anchor system of the first aspect, including but not limited to all technical advantages and alternative embodiments, may be equally applicable to the method of the seventh aspect.

[0417] According to an eighth aspect of the present invention there is provided a method of implanting a soft tissue anchor system according to the second aspect into soft body tissue comprising engaging each arm portion using a respective wire guide member, pushing each arm portion into body tissue using a respective wire guide member, withdrawing each wire guide member and folding each arm portion towards the base portion such that the body tissue is sandwiched between the base portion and each arm portion.

[0418] The method of the eighth aspect of the present invention may have one or more features corresponding to the features of the soft tissue anchor system of the second aspect of the present invention. Thus, the above description of the soft tissue anchor system of the second aspect, including but not limited to all technical advantages and alternative embodiments, may be equally applicable to the method of the eighth aspect.

[0419] According to a ninth aspect of the present invention there is provided a method of manufacturing a soft tissue anchor system according to the second aspect, the method comprising creating a U-shaped fabric body and configuring each arm portion to be folded.

[0420] Creating the U-shaped fabric body may include laser cutting a fabric. The fabric may be selected from the group consisting of polyester, PET, UHMPE, EPTFE, PTFE, and the like.

[0421] The method of the ninth aspect of the present invention may have one or more features corresponding to the features of the soft tissue anchor system of the second aspect of the present invention. Thus, the above description of the soft tissue anchor system of the second aspect, including but not limited to all technical advantages and alternative embodiments, may be equally applicable to the method of the ninth aspect.

[0422] According to a tenth aspect of the present invention there is provided a method of implanting a soft tissue anchor system in soft tissue according to the third aspect, the method comprising embedding each anchor member in soft body tissue and tensioning each of the bridle lines by applying tension to a common bridle point.

[0423] According to an eleventh aspect of the present invention there is provided a method of manufacturing a soft tissue anchor system according to the third aspect, the method comprising connecting each bridle line to a respective anchor member and connecting each bridle line to a common bridle point.

[0424] According to a twelfth aspect of the present invention there is provided a method of repairing the heart by implanting an artificial cord line comprising using a catheter device of the third or fourth aspect to implant a soft tissue anchor system.

[0425] The method of the twelfth aspect of the invention may have one or more features corresponding to the features of the catheter device of the third or fourth aspect of the invention. Thus, the above description of the catheter device of the third and / or fourth aspect, including without limitation all technical advantages and alternative embodiments, may be equally applicable to the method of the twelfth aspect.

[0426] Some exemplary embodiments of the present invention will now be described, by way of example only, with reference to the accompanying drawings, in which: [Brief description of the drawings]

[0427] [Figure 1] 1A-1D illustrate a procedure for inserting a catheter device through the mitral valve. [Diagram 2] FIG. 1 illustrates the operation of a mechanical gripping mechanism using two gripper arms. [Diagram 3] FIG. 1 illustrates the operation of a mechanical gripping mechanism using two gripper arms. [Figure 4]FIG. 1 illustrates the operation of a mechanical gripping mechanism using two gripper arms. [Diagram 5] FIG. 1 illustrates the operation of a mechanical gripping mechanism using two gripper arms. [Figure 6] FIG. 1 illustrates the operation of a mechanical gripping mechanism using two gripper arms. [Figure 7] FIG. 13 illustrates gripping of the mitral valve leaflets by one gripper arm. [Figure 8] 13A-13D illustrate deployment of leaflet anchors in a device using an ejector device. [Figure 9] 13A-13D illustrate deployment of leaflet anchors in a device using an ejector device. [Figure 10] 13A-13D illustrate deployment of leaflet anchors in a device using an ejector device. [Figure 11] 13A-13D illustrate deployment of leaflet anchors in a device using an ejector device. [Figure 12] 13A-13D illustrate deployment of leaflet anchors in a device using an ejector device. [Figure 13] FIG. 13 shows a close-up view of the valve during deployment of leaflet anchors coupled to artificial chordae lines. [Figure 14] FIG. 13 illustrates movement of the distal end of a catheter device into a papillary muscle for placement of a papillary anchor. [Figure 15] FIG. 13 illustrates withdrawal of the treatment catheter portion of the device and adjustment of chord length with an optional adjustment catheter. [Figure 16] FIG. 13 shows an example of a hook for an anchor through which a suture is threaded. [Figure 17] FIG. 13 shows an example of a hook for an anchor through which a suture is threaded. [Figure 18] 1A-1C illustrate a folded configuration of an example nipple anchor. [Figure 19] 1A-1D illustrate a deployed configuration of an example nipple anchor. [Figure 20]13A-13D illustrate withdrawal of the catheter device after implantation of leaflet anchors into the atrial surfaces of the leaflets of the heart valve. [Figure 21] FIG. 1 illustrates a catheter device positioned to implant leaflet anchors in the atrial surfaces of the leaflets of a heart valve. [Figure 22] 1A-1C show alternative configurations of a catheter device positioned to implant leaflet anchors on the atrial surfaces of the leaflets of a heart valve. [Figure 23] 1A-1D show a modified gripper device for gripping the leaflets of a heart valve in a non-deployed configuration. [Figure 24] 1A-1D show a modified gripper device for gripping the leaflets of a heart valve in a deployed configuration. [Diagram 25] FIG. 1 illustrates a fabric anchoring system. [Figure 26] FIG. 13 is a detailed view of the end cap of the fabric anchoring system. [Figure 27A] 13A-13C show the fabric anchor system during implantation into the mitral valve leaflets. [Figure 27B] FIG. 13 shows a fabric anchor system after implantation into the mitral valve leaflets from a lateral view of the ventricle. [Figure 27C] FIG. 13 shows the fabric anchor system after implantation into the mitral valve leaflets from a lateral atrium view. [Figure 28] FIG. 13 shows the end caps of the fabric anchoring system each engaged with a wire guide member. [Figure 29A] 13A-13C illustrate alternative end cap configurations of the fabric anchoring system during implantation into the mitral valve leaflet. [Figure 29B] FIG. 29B is a detailed view of the end cap configuration of the fabric anchoring system shown in FIG. 29A. [Figure 30A] 13A-13C show alternative end cap configurations for the fabric anchoring system. [Figure 30B] 13A-13C show alternative end cap configurations for the fabric anchoring system. [Figure 31A]13A-13C show alternative end cap configurations for the fabric anchoring system. [Figure 31B] 13A-13C show alternative end cap configurations for the fabric anchoring system. [Figure 32A] 13A-13C show alternative end cap configurations for the fabric anchoring system. [Figure 32B] 13A-13C show alternative end cap configurations for the fabric anchoring system. [Figure 33A] 13A-13C show alternative end cap configurations of the fabric anchoring system in a first configuration. [Figure 33B] FIG. 33B illustrates the end cap arrangement of FIG. 33A in a second configuration. [Diagram 34] FIG. 13 shows a wire guide member engaged with an end cap of a fabric anchoring system. [Figure 35A] 1A-1D show a prototype fabric anchor system at various stages during implantation. [Figure 35B] 1A-1D show a prototype fabric anchor system at various stages during implantation. [Figure 35C] 1A-1D show a prototype fabric anchor system at various stages during implantation. [Figure 35D] 1A-1D show a prototype fabric anchor system at various stages during implantation. [Figure 35E] 1A-1D show a prototype fabric anchor system at various stages during implantation. [Fig. 35F] 1A-1D show a prototype fabric anchor system at various stages during implantation. [Figure 35G] 1A-1D show a prototype fabric anchor system at various stages during implantation. [Fig. 35H] 1A-1D show a prototype fabric anchor system at various stages during implantation. [Fig. 35I] 1A-1D show a prototype fabric anchor system at various stages during implantation. [Figure 36A] FIG. 1 is a schematic diagram of a U-shaped fabric anchor system. [Figure 36B] FIG. 36B is a plan view showing a prototype of the fabric anchoring system shown in FIG. 36A. [Figure 36C] FIG. 36B is a plan view showing a prototype of the fabric anchoring system shown in FIG. 36A. [Figure 37A] FIG. 1 is one of various schematic diagrams of a soft tissue anchor system housed within a delivery shaft of a catheter device. [Figure 37B] FIG. 1 is one of various schematic diagrams of a soft tissue anchor system housed within a delivery shaft of a catheter device. [Figure 37C] FIG. 1 is one of various schematic diagrams of a soft tissue anchor system housed within a delivery shaft of a catheter device. [Figure 38] FIG. 13 shows the retraction mechanism of the fabric anchor system. [Figure 39A] 13A-13C show steps for retrieving the fabric anchoring system. [Figure 39B] 13A-13C show steps for retrieving the fabric anchoring system. [Figure 39C] 13A-13C show steps for retrieving the fabric anchoring system. [Figure 39D] 13A-13C show steps for retrieving the fabric anchoring system. [Diagram 40] 13A-13C show alternative end cap configurations. [Diagram 41] FIG. 13 is a plan view of a prototype soft tissue anchor system. [Diagram 42] 13A-13C show alternative end cap configurations. [Figure 43A] 13A-13D show an alternative soft tissue anchor system during a step of implantation into soft body tissue. [Figure 43B]13A-13D show an alternative soft tissue anchor system during a step of implantation into soft body tissue. [Figure 43C] 13A-13D show an alternative soft tissue anchor system during a step of implantation into soft body tissue. [Fig. 43D] 13A-13D show an alternative soft tissue anchor system during a step of implantation into soft body tissue. [Diagram 44] FIG. 13 illustrates a wire guide member having a bulge received by a tubular cap member. [Diagram 45] 1 is a schematic diagram showing a deployment system for implanting a pair of anchor members. [Figure 46A] FIG. 1 illustrates a soft tissue anchor system implanted in the mitral valve leaflets. [Figure 46B] FIG. 46B shows the soft tissue anchor system of FIG. 46A under tension on the line. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0428] The following description details one or more features consistent with and combinable with the above description of the anchoring system. The following embodiments described herein should not be viewed in isolation, are not intended to be limiting, and should be viewed in the context of the present disclosure as a whole, including in light of the accompanying drawings.

[0429] The catheter device presented herein is proposed for non-surgical (endovascular) insertion of mitral chordae to address mitral regurgitation caused by the prolapse of the leaflets 12 of the valve. The figures show different forms of catheter device 2 for this purpose, but it will be understood that the general principle is the same for each device with respect to the implantation of leaflet anchors 10, which are described further below and can be replaced by any of the soft tissue anchor systems according to the invention, and papillary anchors 9 for inserting one or more artificial chordae lines 14 into the heart. The artificial chordae line(s) 14 are fixed to the prolapsed leaflets 12 and the papillary muscles 26, thereby recreating the normal anatomy. A single catheter device 2 is used to place both leaflet anchors 10 (or soft tissue anchor systems as described further below) and papillary anchors 9. Again, the same catheter device 2 can be used to adjust the length of the chordae 14 to eliminate mitral regurgitation. Such catheter devices thus enable the use of a single minimally invasive endovascular procedure to repair the mitral valve, offering a significant advantage over previous systems that required more invasive procedures and / or multiple surgeries.

[0430] It should be noted that while an endovascular approach is preferred and thus the device can be used for this approach, the device can of course be used in different procedures, including more invasive procedures. Many advantages remain and it may be beneficial to use the device in situations where a more invasive procedure would be beneficial. In addition, as noted above, aspects of the design of the nipple anchor 9 or soft tissue anchor system described below can be used for anchors for other purposes, and the disclosure is not intended to be limited in this respect.

[0431] The catheter device 2 described below can be used to insert the mitral valve chordae through the venous system, starting from the femoral vein in the groin. The catheter is advanced into the right atrium. Access to the left atrium is then obtained by a so-called transseptal puncture, after which a larger guiding catheter is advanced into the left atrium. The catheter device 2 for cardiac repair is then introduced into the left atrium through the guiding catheter.

[0432] X-ray and ultrasound guidance are used to position the device, and the mitral valve leaflets 12 are grasped and the artificial chordae lines 14 are attached using either the self-expanding leaflet anchors 10, or the soft tissue anchor system described below, as described in more detail below. The artificial chordae lines 14 are then attached to the papillary muscles 26 using papillary anchors 9. At this point, the chordae lengths can be adjusted to eliminate mitral regurgitation. Excess chordae are then cut and all catheters are withdrawn. Echo and Doppler imaging are used to perform the procedure and monitor the results. Successful use of this endovascular technique dramatically reduces the invasiveness, complications and cost of mitral valve repair.

[0433] Further details regarding the structure and function of the device are described below with reference to the drawings. The procedure for using one form of the device can be summarized as follows. 1) The femoral vein is entered using standard Seldinger technique and a guiding catheter is introduced. 2) The guiding catheter is advanced into the right atrium under X-ray guidance. 3) Enter the left atrium after puncturing the interatrial septum and guided by X-ray and transesophageal echocardiography. 4) The correct location of the entry site in the left atrium is verified to ensure proper alignment for insertion of the guiding and treatment catheters. The entry hole in the interatrial septum is dilated and the guiding catheter is advanced into the left atrium. 5) The therapeutic catheter device 2 is advanced through the guiding catheter and positioned in the left atrium above the mitral valve. 6) The prolapse segment of the mitral valve leaflet 12 is located by 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 grasp the prolapse segment. 7) After the prolapse segment has been grasped and properly positioned, the leaflet anchor 10 is pushed through the leaflets 12, allowing them to open and be secured in place, or a soft tissue anchor system, as described below, is deployed. 8) The connection of the valve leaflet to the anchor can be tested while it remains attached to the catheter device 2 via the ejector unit 36, and if the connection is sufficient, the distal end of the catheter is advanced further into the left ventricle. 9) The nipple anchor 9 is pushed into the area of ​​the papillary muscle 26 and pushed out of its housing 8, thereby opening the nipple anchor 9 inside the papillary muscle 26. 10) If the gripper 6 is still gripping the leaflet 12, it is released, for example by releasing the leaflet anchor 12 from the ejector unit 36. 11) Adjust the length of the artificial chordae line 14 until mitral regurgitation is eliminated. 12) The catheter device 2 is withdrawn from the nipple anchor 9, and elimination of mitral regurgitation is again confirmed by echocardiography. 13) Lock the position of the artificial cord line 14 at the nipple anchor 9. 14) Cut off excess cable line 14. 15) Additional cord lines may be placed if necessary. 16) The catheter device is completely withdrawn and removed from the vasculature.

[0434] 1-19 show an exemplary catheter device 2 as disclosed in WO 2020 / 109596. Although the catheter device 2 disclosed in WO 2020 / 109596 is used to implant a leaflet anchor 9 in combination with an artificial chordae line 14 from the ventricular side of the mitral valve leaflet 12, many of the features and / or components of the exemplary catheter device 12 may be compatible with the catheter device 102 of the present invention or may be modified in accordance with the teachings of the present invention such that a leaflet anchor 110 in combination with an artificial chordae line 114 may be implanted in the leaflet 12 from the atrial side of the leaflet 12, as shown in FIGS.

[0435] FIG. 1 shows a guide catheter 22 that was used to steer the catheter device 2 to a required position in the heart that extends through the mitral valve and thus lies between the two valve leaflets 12. The catheter device 2 is composed of four distinct main parts, namely, a steerable catheter, a gripper housing 4, a gripper device 6, and a nipple anchor housing 8 that holds a nipple anchor 9. The gripper housing 4 and nipple anchor housing 8 may form the proximal portion 4 and distal portion 8 of a two-part housing section having a central flexible expansion joint 34, as shown in FIGS. 2-6, 14, and 20-22. It should therefore be understood that the procedure shown in FIG. 1 (and similarly in FIGS. 7, 13, and 15) may use this configuration for the gripper housing (proximal portion) 4 and nipple anchor housing (distal portion) 8. The steerable catheter may be replaced with an alternative configuration that uses a steerable sheath around the steerable catheter and a flexible tube within the steerable catheter.

[0436] FIG. 1 shows a front view of one exemplary catheter device with the gripper device 6 in a closed state. Some configurations of the gripper device 6 use a single gripper arm 30 to grip the leaflet 12 against the gripper housing portion 4, as shown in FIG. 7. In other configurations, the gripper device 6 uses two gripper arms 30, 32, as shown in FIGS. 2-6, to allow the gripper device 6 to grip the leaflet 12 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 or a soft tissue anchor system, described below, and attaching it to the leaflet 12 of the heart. In the illustrated example, the gripper device 6 includes a leaflet anchor tube 38 for receiving the leaflet anchor 10 in a folded configuration prior to deployment. In an exemplary embodiment, the leaflet anchor tube 38 is within the (first) gripper arm 30, as seen, for example, in FIGS. 2 and 4. Once the gripper device 6 has gripped the leaflet 12, the leaflet anchor 10 may be pushed out of the leaflet anchor tube 38 to pierce the leaflet 12 and form the leaflet anchor 10 into a deployed configuration such that the hook-like formation 40 of the leaflet anchor 10 may secure it within the leaflet 12. Alternatively, a soft tissue anchor system as described below may be implanted by piercing the leaflet as shown in the subsequent figures.

[0437] The leaflet anchor 10 or soft tissue anchor system described below is connected to the artificial chordae line 14, which can be seated in a narrow channel that extends along the surface of the first gripper arm 30 (e.g., as shown in Figures 8-12), through the nipple anchor housing 8, and to the nipple anchor 9 (e.g., as shown in Figures 20-22). The channel can be slightly smaller than the diameter of the artificial chordae line 14 and / or have a thin shielding structure (not shown). This allows the artificial chordae line 14 to be seated in place due to a friction fit. The artificial chordae line 14 enters the nipple anchor housing 8, passes through the nipple anchor locking section, and through the locking cut piece. The artificial chordae line 14 can be attached to a wire that runs back along the entire catheter to the outside (to make adjustments easier). The wire can be pushed through the catheter, allowing the wire to shorten the chordae by pulling, or to lengthen the chordae during the procedure.

[0438] The two-piece housing section having the gripper 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.

[0439] 2-6 show the steps of movement of the gripper mechanism 6 in the example with two gripper arms 30, 32 as described above. This gripper mechanism 6 is part of a housing section that also includes a flexible expansion joint that allows the papillary anchor housing 8 (distal part) to be moved towards the papillary muscle 26 after the leaflet 12 has been gripped by the gripper mechanism 6. In this example, to grip the leaflet 12, the first gripper arm 30 is rotated to move its end 42 outward from the body of the catheter device, this rotation being enabled via a weakened area 44 in the tubular form of the body. It can be seen that the leaflet anchor tube 38 is seated inside the first gripper arm 30, the end of the leaflet anchor tube 38 having an opening at the end 42 of the first gripper arm 30. With the first gripper arm 30 open, the second gripper arm 32 is free to rotate to move its end 46 outward from the body. In this example, the second gripper arm 32 rotates about a hinge formed by a pin 48 located in a hole in the proximal part 4 of the two-part housing section, although it will be understood that a similar final positioning of its end 46 can be achieved by a sliding motion. With the second gripper arm 32 folded outward, the first gripper arm 30 can close so that the two ends 42, 46 come into contact at a point spaced apart from the body of the device, thereby gripping the leaflet 12. With the leaflet 12 in place, the leaflet anchor 10 can be moved outwardly from the leaflet anchor tube 38 and embedded, such as via a mechanism with an ejector unit 36 ​​as described below in connection with Figures 8-12, with the final positioning of the leaflet anchor 10 being similar to that shown in Figure 13.

[0440] Figure 7 shows an alternative form of gripper mechanism 6 which grips the leaflet 12 using a single gripper arm which holds the leaflet 12 against the gripper housing 4. This can also use the ejector unit 36 ​​mechanism of Figures 8-12.

[0441] Raised surfaces on the gripper arm(s) 30, 32 may be provided to assist the gripper arms in gripping the leaflet 12. 3D ultrasound and / or other available sources may be used to confirm that the gripper mechanism 6 has gripped the correct portion of the leaflet 12. The gripper mechanism 6 can be opened and closed as many times as necessary to grip the correct portion of the leaflet 12. Opening and closing can be facilitated by a system that allows one wire to pull the gripper mechanism 6 open and one wire to pull the gripper mechanism 6 closed. As discussed above, different configurations of wires and / or rods can be used to control the example having two gripper arms 30, 32. Once the position of the gripper mechanism 6 is confirmed, the leaflet anchor 10 can be pushed out of the end of the leaflet anchor tube 38, such as by pulling on a wire at the other end of the catheter. FIG. 13 shows a close-up view of the leaflet anchor 10 positioned within the leaflet 12 with the hook-like formation 40 engaged with the leaflet 12.

[0442] As mentioned above, an ejector unit 36 ​​may be used as shown in Figures 8-12. By using the ejector unit 36, the leaflet anchor deployment mechanism allows for retraction and repositioning of the leaflet anchor 10 after deployment of the anchor 10 into the leaflet 12. This is accomplished via the ejector unit 36 ​​including a grasping device 50 having a first configuration as shown in Figures 8 and 9 and a second configuration as shown in Figures 10 and 11.

[0443] If during an examination the physician is not satisfied with the connection (e.g., if there is too much movement of the anchor 10 and / or there is not enough resistance to the forces on the line), the leaflet anchor 10 can be retracted and placed in another location.

[0444] A groove 52 is provided in the wall of the leaflet anchor tube 38 to guide the ejector unit 36. The groove 52 ensures that the ejector unit 36 ​​remains in a single orientation relative to the tube 38 while moving along the tube. The groove 52 can set a maximum limit on the range of movement of the ejector unit 36, thus preventing it from moving too far in either direction, out or into the leaflet anchor tube 38. The ejector unit 36 ​​has a guide pin 56 for engaging with the groove 52. A constriction 54 in the groove 52 is provided to act as an indicator to inform the practitioner that the ejector unit 36 ​​has reached a certain position. The size of the guide pin 56 and the width of the constriction 54 are set such that engagement of the pin 56 with the constriction 54 in the groove 52 requires increased force before further movement can occur, thus providing tactile feedback to the operating physician.

[0445] The leaflet anchor deployment mechanism of Figures 8-12 also includes a line pusher 58 for guiding the artificial chordae line 14 in and out of the leaflet anchor tube 38 during deployment of the anchor 10. The line pusher 58 guides the artificial chordae line out of the leaflet anchor tube 38 so that it is more easily accessible for subsequent manipulations such as tightening the line 14 or pulling on the implanted leaflet anchor 10 to test the connection. The line pusher 58 is actuated during the deployment operation of the leaflet anchor 10, and this actuation is triggered when the leaflet anchor 10 is released from the ejector unit 36. This causes the line pusher 50 to be released as the ejector unit 36 ​​retracts from the implanted leaflet anchor 10.

[0446] In the illustrated example, the line pusher 58 transitions from a constrained to an unconstrained state and moves radially outward to push the line 14, and this radially outward movement is permitted, with the line pusher being released when the constraint from the leaflet anchor 10 is removed. The line pusher 58 is an arm that extends axially forward from the ejector unit towards the leaflet anchor 10 and radially outward from the leaflet anchor tube 38 when at rest with no applied force.

[0447] The papillary anchor housing 8 at the end of the treatment catheter is placed on the papillary muscle 26 by embedding the leaflet anchor 10 or a soft tissue anchor system, described below, in the leaflet 12. This can be done as shown in FIG. 14 by using a flexible expansion joint 34. In this example, the flexible expansion joint 34 is formed by a flexible serpentine section cut into the tubular shape of the body. The flexible expansion joint 36 is integrally formed with the tubular distal part 8, which provides the papillary anchor housing 8, and with the tubular proximal part 4, which provides the gripper housing 4. Furthermore, the tubular form of the gripper housing 4 can include integrally formed gripper arms 30, with weakened portions 44 of the tube providing the hinge. The flexible expansion joint 34 can be stretched by wires and / or rods 60 (or via the adjustment catheter 21, which can also push out the papillary anchor 9) that can apply a force that stretches the elastic element of the joint 34. This stretching is used to move the nipple anchor 9 within its housing section 8 to position it against or near the papillary muscle 26, as the wire / rod with nipple anchor 8 within the distal housing section 8 moves with the housing 8 as the joint 34 stretches. This may be due to friction between the nipple anchor 9 (or nipple anchor pusher tube) and the inner surface of the distal part 8 of the housing section. The position may be confirmed by 3D ultrasound and / or other available sources.

[0448] As the distal end of distal section 8 meets the tissue and further force is applied, the reaction force from the tissue eventually overcomes the force holding nipple anchor 9 in place, at which point the tissue is pressed flat under the base of distal section 8, giving the greatest opportunity to accurately position all pins 62 of nipple anchor 9 within the tissue, and then force can be applied to nipple anchor 9 such that the ends of pins 62 move beyond the distal end of distal section 8 to meet the tissue. This may be done via additional force on nipple anchor 9 from rod or wire 60, or by stretching adjustment catheter 21, or by pretension on nipple anchor 9, which is held by friction with the distal section (or friction between adjustment catheter 21 and distal section 8), until the force from the tissue on distal section 8 sufficiently changes the balance of forces with friction such that nipple anchor 9 is released in a manner similar to a paper stapler. Once nipple anchor 9 is released, pins 62 fold and form into a hook-shaped unconstrained nipple anchor 9, thereby engaging tissue 26. At this point, the connection can be pull tested by the practitioner and / or visually verified with x-ray and / or ultrasound. If the connection is poor, the nipple anchor 9 can be pulled back to the distal portion 8 and repositioned to attempt to improve the attachment of the anchor 9 to the body tissue 26.

[0449] Figure 15 shows a possible next step. The main parts of the device 4, 8 are retracted to minimize the impact on the moving leaflets 12. The adjustment catheter 21 can remain in the papilla anchor 9. The length of the artificial chordae line 14 can be adjusted with a wire from the outside. The length is continuously adjusted and the function of the leaflets 12 is monitored. The length of the artificial chordae line 14 can be shortened by pulling the chordae wire back through the catheter. The length can also be increased by pushing the chordae wire, which relaxes the artificial chordae line 14 and allows the movement of the leaflets 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 leaflets 12 is minimized. The appropriate length of the artificial chordae line 14 is confirmed by 3D ultrasound and / or other available sources.

[0450] Once the correct length is confirmed, the device is disengaged from the nipple anchor 9. This process also locks the artificial cord line 14 in place and cuts off any excess that is held in the catheter and will be pulled out of the body when the catheter is removed. The locking segment 28 of the nipple anchor 9 is held open by a cutting piece (not shown). The locking segment 28 is a band of the nipple anchor 9 that can bend to open a gap for the artificial cord line 14 to pass through. In the natural shape of the nipple anchor 9, when no force is applied, this locking segment 28 fits closely with the rest of the anchor 9, thus holding the artificial cord line 14 in place. The locking segment 28 is held open until the artificial cord line 14 is the correct length. The cutting piece cuts the artificial cord line 14 which is pulled against the blade when the adjustment process is complete.

[0451] 16-19 include further details of the nipple anchor 9, including its hook 62 formed by the curved pin 62. FIGS. 8 and 9 show one possible configuration of the hook 62 having a central slit 64 and a series of holes 66 through which a suture 68 is threaded. As discussed above, the suture 68 and holes 66 allow the hook 62 to better engage body tissue during healing while also allowing the material of the hook 62 to remain connected to the body of the nipple anchor 9 in the event of breakage. FIG. 16 shows the folded / constrained shape of the hook 62, which is also the shape of the tines formed on the tubular section during manufacture of the anchor 9, prior to heat setting to form the curve. FIG. 17 shows the curved, i.e., deployed / unconstrained, configuration of the hook 62.

[0452] Figures 18 and 19 show one example of a complete nipple anchor 9, again shown in a folded (Figure 18) and deployed (Figure 19) configuration. This nipple anchor 9 includes a hook 62 having an opening in the form of a slit 64, which may provide better engagement with the healing body and increased surface area without loss of flexibility.

[0453] The catheter device 2 disclosed in each of WO 2016 / 042022 and WO 2020 / 109596 implants the leaflet anchor 10 from the ventricular side of the leaflet 12. Thus, as shown in FIG. 15 , the artificial chordae lines 14 descend from the leaflet 12 from the ventricular surface of the leaflet 12 to the papillary muscle 26. As discussed in each of WO 2016 / 042022 and WO 2020 / 109596, there are several advantages associated with implanting the leaflet anchor 10, or soft tissue anchor system described below, and thus the artificial chordae lines 14, on the ventricular side of the leaflet 12.

[0454] However, there may be situations in which it is advantageous to implant the leaflet anchors 110 or soft tissue anchor system described below, and therefore the artificial chordae lines 114, from the atrial side of the leaflet 12. For example, as seen in FIG. 15, the artificial chordae lines 14 descend to the papillary muscles 26 without providing any additional support to the edges 13 of the leaflet 12. When implanted from the ventricular side of the leaflet 12, the artificial chordae lines 14 do not provide additional support to the edges 13 of the leaflet 12. Thus, the implanted artificial chordae lines 14 may not replicate as accurately as desired the action of the chordae tendineae that are located toward the edges 13 of the leaflet 12.

[0455] Implanting leaflet anchor 10, or a soft tissue anchor system, described below, from the ventricular side of leaflet 12 also requires more precise placement of leaflet anchor 10. Because no additional support is provided to edge 13 of leaflet 12, the placement of leaflet anchor 10 determines the extent to which edge 13 of leaflet 12 is supported and / or secured by leaflet anchor 12. In contrast, because artificial chordae lines 114 provide additional support to edge 13 of leaflet 12 as it enters the ventricle from the atrium of the heart, placement of leaflet anchor 110, or a soft tissue anchor system, described below, implanted from the atrial side of leaflet 12 can be less precise.

[0456] 20 illustrates the withdrawal of the guide catheter 122 and the distal portion 108 of the catheter device 102 when the artificial chordae lines 114 have been implanted in the papillary muscles 26 using the papillary anchors 109 and the artificial chordae lines 114 have also been implanted in the leaflets 12 of the heart valve using the leaflet anchors 110 or a soft tissue anchoring system described below. The adjustment catheter 121 is shown in position prior to its withdrawal. The length of the artificial chordae lines 114 can be adjusted as needed in the configuration shown.

[0457] FIG. 20 illustrates a leaflet anchor 110 similar to the arrangement shown in FIG. 15, but implanted from the atrial side of the leaflet 12 instead of the ventricular side. As seen in FIG. 2, the artificial chordae lines 114 extend from the base of the leaflet anchor 110 to which they are attached toward the leaflet edge 13. Because the artificial chordae lines 114 are under tension or otherwise take the shortest possible path to the papillary muscle 26 in which their other ends are implanted, the artificial chordae lines 114 contact the atrial side of the leaflet 12 and descend over and into the edge 13 of the leaflet 12. Thus, the artificial chordae lines 114 implanted on the atrial side of the leaflet 12 provide additional support to the edge 13 of the leaflet 12.

[0458] The artificial cord lines 114 may include regions of varying cross-sectional area along their length. By increasing the cross-sectional area of ​​the artificial cord lines 114 at a particular cross-section, the area of ​​contact of the artificial cord lines 114 with the heart valve leaflets 12 may be increased. Thus, the force exerted by the artificial cord lines 114 on the leaflets 12 may be more evenly distributed, avoiding any pinching of the leaflets 12 that the artificial cord lines 114 may cause.

[0459] The artificial chordae lines 114 include a flattened cross-section proximal to the leaflets 12, i.e., such that the long axis of the cross-sectional area of ​​the artificial chordae lines 114 is parallel to the surface of the leaflets 12. In an alternative configuration, the artificial chordae lines 114 can be formed from multiple sutures to increase the contact area between the artificial chordae lines 114 and the atrial surface of the leaflets 12.

[0460] To implant the leaflet anchor 110 into the heart valve leaflet 12 from the atrial side, the leaflet anchor deployment mechanism and gripper housing 106 of the catheter device 102 are positioned as shown in either FIG. 21 or FIG.

[0461] FIG. 21 shows a catheter device 102 with a gripper housing 106, a gripper arm 130, and an artificial chordae line 114 attached to a leaflet anchor 110 or a soft tissue anchor system, described below, routed through the body of the catheter device 102. In the example of these figures, the leaflet anchor 110 is housed in the body of the catheter device 102 and deployed by pushing it out of a leaflet anchor tube 138 located within the body of the catheter device 102. The function of the leaflet anchor tube 138 is similar to the leaflet anchor tube 38 described above. The leaflet anchor tube 138 is positioned in the body of the catheter device 102 such that when the leaflet 12 is gripped between the gripper arm 130 and the body of the catheter device 102 (as shown in FIG. 7), the leaflet anchor 110 can be deployed from the anchor tube 138 to the atrial side of the leaflet 12. Thus, the leaflet anchor 110 is deployed into the leaflet 12 as shown in FIG. 20. Through the use of the soft tissue anchor system described below, the catheter device 102 can be adapted to replace the leaflet anchor tubes 138 of these figures with alternative anchor deployment mechanisms, such as tubes of different design for holding and guiding the arm(s) of the fabric body as they are implanted into the leaflets.

[0462] FIG. 22 shows an alternative configuration of the catheter device 102 including the gripper housing 106, gripper arms 130, and the artificial chordae line 114 attached to the leaflet anchor 110. Although not shown, the artificial chordae line is routed through the gripper arms 130 and the body of the catheter device 102 so that the artificial chordae line 114 can be deployed from the catheter device 102 once the line 114 has been adjusted after implantation. The leaflet anchor 110 is contained within a leaflet anchor tube 110 disposed within the gripper arms 130, with the opening of the leaflet anchor tube 138 disposed at the distal end of the gripper arms 130. As shown in FIG. 20, the gripper arms 130 are rotated from the proximal end of the catheter device 102 so that the opening of the leaflet anchor tube 138 is disposed adjacent the atrial aspect of the leaflet 12 so that the leaflet anchor 110 can be deployed to the atrial side of the leaflet 12. This can also be adapted for use with a deployment configuration for the soft tissue anchor system described below.

[0463] In both the configurations shown in Figures 21 and 22, the components of catheter device 102 may function similarly to the components described in connection with Figures 1-19. Leaflet anchor tube 138 operates generally similarly to leaflet anchor tube 38 described in connection with Figures 6-12. Gripper device 106 functions similarly to gripper device 6 described in connection with Figures 2-6. Papilla anchor 109 is similar to leaflet anchor 9 described above.

[0464] 21 and 22 , and as described above, the leaflet anchor tube 138 extends in a direction along the body or gripper arm 130 of the catheter device 102 such that the opening of the leaflet anchor tube 138 opens towards the distal end of the catheter device 102. Thus, when the catheter device 102 approaches the leaflets 12 and papillary muscles 26 from above, i.e., from the left atrium as described above, the opening of the leaflet anchor tube 138 is positioned to coincide with the atrial surface of the leaflet 12 such that the leaflet anchor 110 can be embedded into the atrial surface of the leaflet 12.

[0465] The catheter devices taught in WO 2016 / 042022 and WO 2020 / 109596 used U-rods to deploy the leaflet anchors. However, the catheter device 102 uses a linear rod to deploy the leaflet anchor 110. This configuration can also be utilized for deployment of the soft tissue anchor system described below. The linear rod extends from the proximal end of the catheter device 102 into the leaflet anchor tube 138, so that the leaflet anchor 110 or the soft tissue anchor system described below can be deployed on the atrial side of the leaflet 12. The linear rod can be deployed by pushing it out of the distal facing opening of the leaflet anchor tube 138 using the end of the linear rod disposed in the leaflet anchor tube 138. The linear rod is flexible so that it can bend or bend into the gripper arm 130 when bent, for example, from the body of the catheter device 102 shown in FIG. 22, and is stretchable so that it can be pushed into and retracted from the leaflet anchor tube 138 without stretching. As shown in FIG. 22, once the leaflet anchor tube 138 is placed in the gripper arm 130, the elastic properties of the linear rod can help restore the gripper arm 130 to the closed position, i.e., flush with the body of the catheter device. The linear rod is made from a material that has the ability to deform highly elastically to allow bending of the bendable section. Suitable materials include shape memory materials, for example shape memory metals such as Nitinol. Using a shape memory metal also means that the linear rod can be made stiff, making the transmission of forces by the linear rod more efficient. Alternatively, the linear rod can be made from several types of materials to achieve the required properties.

[0466] The following features will be described in relation to catheter device 102 as described in relation to Figures 20-22, but it will be understood that the following features are similarly compatible with catheter device 2 as described in relation to Figures 1-19 and disclosed in each of WO 2016 / 042022 and WO 2020 / 109596.

[0467] 23 and 24 show an alternative configuration of the gripper device 106. The gripper device 106 includes a gripper arm 130 in combination with a gripper lever 132. At rest, i.e., in a non-deployed configuration, the gripper lever 132 is biased such that the gripper lever sits flush with the main housing of the catheter device 102, as shown in FIG. 41. The gripper lever 132 is disposed between the gripper arm 130 and the body of the catheter device 102, such that the gripper lever 132 cannot be actuated outwardly from the body of the catheter device 102 without first opening the gripper arm 130, as shown in FIG.

[0468] The gripper lever 132 is fixed at an end adjacent to where the gripper arm 130 is rotated from. The other end of the gripper lever 132 is free to move relative to the body of the catheter device 102. The free end of the gripper lever 132 is attached to a wire or rod 134 that extends through the body of the catheter device 102 and pushes against the free end of the gripper lever 132. Thus, when pushed, the rod 134 actuates the gripper lever 132 to a deployed configuration. In the deployed configuration, the free end of the gripper lever 132 is positioned to meet the gripper arm 130. Thus, in use, the valve leaflet 12 can be gripped between the gripper arm 130 and the gripper lever 132.

[0469] The combined gripping action of the gripper arms 130 and the gripper levers 132 can help ensure that the leaflets 12 are accurately gripped. The gripper arms 130 can open so that the gripping surfaces 136 of the gripper arms 130 meet the leaflets 12. Without additional support, movement of the leaflets 12 during the cardiac cycle can cause the leaflets 12 to move outward from the gripper arms 130 when the gripper arms 130 are closed. However, the present configuration of the gripper device 106 deploys the gripper levers 132 before the gripper arms 130 are closed. Thus, the leaflets 12 are secured between the gripper levers 132 and the gripper arms 130 before the gripper arms 130 are closed. Finally, the gripper levers 132 and the gripper arms 130 can be withdrawn with the leaflets 12 still secured such that the leaflets 12 are secured in a desired position between the gripper arms 130 and the body of the catheter device 102 when the gripper arms 130 are in the closed position. Leaflet anchor 110 may then be deployed to the desired location. Thus, providing gripper lever 132 may help increase the likelihood of successfully gripping leaflet 12 and ensure correct positioning of leaflet anchor 110, or a soft tissue anchor system as described further below, within leaflet 12 during implantation of leaflet anchor 110, or a soft tissue anchor system as described further below.

[0470] The gripper lever 132 may include several indentations or teeth along its length, which may aid in gripping the leaflet 12. The indentations or teeth increase the frictional hold of the gripper lever 132, so that the leaflet 12 is less likely to be accidentally released from the gripper arm 130 and gripper lever 132 when it is gripped. The gripper lever 132 is generally flexible so that it can be held at the end where the gripper arm 130 rotates and pushed at the free end by the rod 134 to meet the gripper arm 130. The gripper lever 132 and rod 134 may each be formed from a suitable elastic yet stretchable material, such as Nitinol or stainless steel. The gripper lever 132 may be secured to the body and rod 134 of the catheter device 102 by welding or gluing the components together.

[0471] Although the gripper lever 132 is described herein as being flush with the body of the catheter device 102 when unconstrained and contacting the gripping surface 136 when within the rod 134, the gripper lever 132 may alternatively be flush with the gripping surface 136 of the gripper arm 130 when unconstrained. Thus, when the rod 134 pulls on the free end of the gripper lever 132, the gripper lever 132 opens outwardly from the gripper arm 130. The leaflet 12 may then be gripped between the open gripper lever 132 and the open gripper arm 130. Thus, when the rod 134 is released, the gripper lever 132 returns to its unconstrained position, thus gripping the leaflet 12 between itself and the gripper arm 130. Biasing the gripper lever 132 to grip the leaflet 12 when no force is applied may result in a more secure and / or reliable retention of the leaflet 12.

[0472] As briefly mentioned above, embodiments of the present invention relate to a soft tissue anchor system as described herein. The soft tissue anchor system described herein may be used in a catheter device 2 of the type described above in connection with Figures 1-24, and to that end, the leaflet anchors 10, 110 shown in those figures may be replaced with the soft tissue anchor system described below and in connection with the remaining figures, with other modifications apparent to those skilled in the art.

[0473] The soft tissue anchor systems shown in or discussed in connection with the remaining figures are for implantation into soft body tissue, and more specifically may be used as leaflet anchor systems for use in surgical repair of mitral valve leaflets, where the leaflet anchor system is used to attach a prosthetic line to the leaflets of the heart during repair. This type of repair is discussed in both WO 2016 / 042022 and WO 2020 / 109588, and as described above in connection with Figures 1-24.

[0474] However, in contrast to the concepts disclosed in WO '022 and WO '588, in some embodiments the anchoring system uses a fabric-type construction in which two arms of a U-shaped fabric body pass through body tissue and then fold accordion-like to sandwich the body tissue between the base portion of the U-shaped fabric body and each arm portion of the U-shaped fabric body.

[0475] 25 shows a soft tissue anchor system 200 including a U-shaped fabric body 201 according to the present invention. The U-shaped fabric body 201 comprises a base portion 202 and two arm portions 204 extending from the base portion 202. A thin body portion 203 extends between the base portion 202 and each respective arm portion 204. The soft tissue anchor system 200 comprising multiple arm portions 204 connected by a single base portion 202 can increase the surface area of ​​the anchor system 200 on both sides of the body tissue when engaged with the body tissue. This can improve the stability of the anchor system 200 when embedded in the body tissue.

[0476] The U-shaped fabric body 201 is used to secure the artificial cord line 214 disposed toward the base portion 202 to the body tissue. It will be understood that being a fabric body, the U-shaped fabric body 201 is formed primarily from soft materials. The U-shaped fabric body 201 may be functionally equivalent to a pledget. In some embodiments, as shown in FIG. 25, the base portion 202 includes a shape-retaining feature 205 embedded therein, such as a Nitinol wire frame or the like. The shape-retaining feature 205 can help the base portion 202 retain its shape over time and / or provide additional lateral support to the body tissue when implanted. The arm portion 204 can also be optionally provided with a reinforcing element 206.

[0477] The U-shaped fabric body 201 also includes a tension line 214'. Each arm 204 includes a portion of the tension line 214' threaded through the arm 204 and the base 202, with the line extending from the end of the arm 204 distal to the base 202 to the base 102. Each portion of the tension line 214' is fixed toward the distal end of the arm 204, but is otherwise free to move along the arm 204 relative to a thread hole 207 formed in the base 202.

[0478] Each arm portion 204 may be configured to fold toward the base portion 202 by the action of a tension line 214' threaded through the arm portion 204. That is, the tension line 214' can cause the arm portion 204 to fold toward the base portion 202 when tension is applied to the tension line 214'. In other words, the tension line 214' threaded through the arm portion 204 is an example of a means for folding each arm portion 204 toward the base portion 202 such that body tissue is sandwiched between the base portion 202 and each arm portion 204 during use. Because the U-shaped textile body 201 is formed primarily from a soft material, the arm portion 204 is folded in an accordion-like manner (i.e., folded toward the base portion 202) as a result of the actuation of the tension line 214' from an end distal to where the portion of the line 214' is fixed to the arm portion 204.

[0479] Additionally, an end cap 208 is disposed on the end of the arm portion 204 distal to the base portion 202. The end cap 208 is a rigid structure that aids in embedding the U-shaped woven body 201 into body tissue and helps maintain the U-shaped woven body 201 in engagement with the body tissue.

[0480] FIG. 26 shows a closer view of Detail A' of FIG. 25. The portion of the line 214' threaded through the arm 204 is secured to the distal end of the arm 214' via the end cap 208. In the embodiment shown in FIGS. 25 and 26, each respective end of the tension line 214' is received by and secured within an opening 211 in each respective end cap 208. Each end cap 208 also includes an opening 210 for receiving a wire guide member 218, as described in more detail below. The use of end caps 208 to receive a wire guide member 218 for implanting the anchoring system 200 can facilitate easier implantation since the fabric body 201 does not need to be implanted from within a hollow needle. Thus, a narrower piercing member can be used to deploy the soft tissue anchoring system 200, thereby reducing trauma to the implantation site.

[0481] Figures 27A, 27B and 27C show a soft tissue anchor system 200 implanted in a mitral valve leaflet 12 of the heart. The base portion 202 is positioned to contact the atrial surface 12a of the leaflet 12 and the bellows-like arm portions 204 (as in Figures 27B and 27C) are positioned to contact the ventricular surface 12b of the leaflet 12. Thus, the leaflet 12 is sandwiched between the base portion 202 and the arm portions 204 in use.

[0482] 27B and 27C, the artificial cord line 214 provides tension to the tension line 214', as indicated by arrow T, thereby drawing its fixed end toward the base portion 202. This causes the arm portion 204 to collapse into a bellows-contracted position.

[0483] The artificial rope line 214 may be joined to the tension line 214' via any suitable fastening means, such as a knot or eyelet. In the embodiment shown in Figure 27B, the artificial line 214 is joined to the tension line 214' via a knot 215.

[0484] 27A and also 29A and 29B, to embed the U-shaped fabric body 201, a pair of wire guide members 218 are utilized. The wire guide members 218 are each received by an opening 210 in the end cap 208. The wire guide members 218 are used to push the end cap 208 through the leaflet 12 and into piercing engagement with the leaflet 12 such that the U-shaped fabric body 201 engages the leaflet 12. In this configuration, the end cap 208 extends in line with the arm portions 204. The wire guide members 218 can then be retracted once the U-shaped fabric body 201 is embedded into the leaflet 12. As a result of withdrawing the wire guide member 218, the end cap 208 can return to an orientation perpendicular to the arm portion 204 when at rest, or parallel to the folding plane of the arm portion 204 when the arm portion 204 is folded (e.g., as in Figures 27B and 27C).

[0485] Figure 28 shows the end cap 208 in further detail when engaged with the wire guide member 218. The end cap 208 has a tip 209 which is a blunt or rounded tip 209 in each of Figures 25-28. Providing a blunt or rounded tip 209 can reduce the risk of tearing or abrasion of the leaflet 12 by the end cap 208 becoming embedded in the leaflet 12.

[0486] The wire guide member 218 shown in Figures 27A and 28 passes through the end cap 208 and is itself used to pierce the leaflet 12 while pushing the end cap 208 through the leaflet 12. In the configuration shown in Figures 27A and 28, the wire guide member 218 includes a piercing section 219. The piercing section 219 includes a distal tip configured to pierce the leaflet 12 during implantation of the soft tissue anchor system 200. Thus, in the configuration shown in Figures 27A and 28, the wire guide member 218 can be considered a piercing wire guide member 218. The opening 210 in the end cap 208 extends substantially along the entire length of the end cap 208 to allow the piercing wire guide member 218 to pass therethrough. To aid in manipulation of the end cap 208, the wire guide member 218 includes a thicker control section 220. A shoulder 221 is disposed between the thinner piercing section 219 and the thicker control section 220 and is configured to engage a complementary portion of the end cap 208. As a result of transmitting force to the end cap 208 in this manner, the arm portion 204 is pulled through an implantation site formed by each piercing section 219 of the wire guide member 218.

[0487] However, in other configurations not shown, the wire guide member 218 may comprise a first hollow shaft that is used to push against the end cap 208, with a second puncture wire passing through the hollow shaft to puncture tissue. This configuration provides more degrees of freedom, but also includes more components.

[0488] 29A and 29B, in some embodiments, the tip 209 of the end cap 208 distal to the arms 204 is pointed, allowing the end cap 208 to pierce the leaflet 12. When the tip 209 of the end cap 208 is pointed, the wire guide member 218 is used to transfer force to the end cap 208 to pierce the leaflet 12 and to pull the arms 204 through an implantation site created in the leaflet 12 by the pointed tip 209 of the end cap 208.

[0489] 30-32 show various configurations of end cap 208 having a blunt or rounded tip 209. In each configuration, end cap 208 comprises an outer tubular member 208a and an inner tubular member 208b. The inner tubular member 208b is received by the outer tubular member 208a such that the inner tubular member 208b is concentrically nested within the outer tubular member 208a. The outer tubular member 208a and the inner tubular member 208b each define an opening extending along their length such that the resulting end cap 208 can receive a wire guide member 218 and, in each configuration shown in FIGS. 30-32, the puncture section 219 can pass completely through the end cap 208. The inner tubular member 208b defines an opening 210 for receiving the wire guide member 218.

[0490] The outer tubular member 208a defines an opening 211 for receiving a tension line 214' and a notch or groove 212 to facilitate connection of the arm portion 204 of the U-shaped fabric body 201 to the end cap 208. The notch 212 can aid in positioning the arm portion 204 relative to the end cap 208 such that the opening 210 in the end cap 208 is not blocked or obstructed by the end cap 208.

[0491] As shown in each of FIGS. 30-32, tension line 214' and arm 204 are received between outer tubular member 208a and inner tubular member 208b. Arm 204 extends along inner tubular member 208b, while tension line 2124' is wrapped around inner tubular member 208a. Tension line 214' and arm 204 are secured between outer tubular member 208a and inner tubular member 208b by crimping outer tubular member 208a. Thus, outer tubular member 208a is made from a crimpable material such as stainless steel, titanium, and the like. Inner tubular member 208b is formed from a shape-retaining material such as Nitinol, stainless steel, titanium, and the like. In the embodiment shown here, outer tubular member 208a has an outer diameter of 1.0-1.1 mm and a length of 3 mm.

[0492] In each of Figures 30-32, the shape of the wire guide member 218 is shown in further detail. As described above, the wire guide member 218 comprises a control section 220 for transmitting a driving force to the end cap 208, a puncture section 219 for puncturing the valve leaflet 12, and a shoulder 221 extending therebetween. In the embodiment shown here, the control section 220 has a diameter of 0.4 mm and the puncture section 219 has a diameter of 0.3 mm. The shoulder 221 is sloped, thus defining a transition between the control section 220 and the puncture section 221.

[0493] Turning specifically to the first configuration shown in Figures 30A and 30B, the end cap 208 has a blunt tip 209. The inner tubular member 208b and the outer tubular member 208a are misaligned such that the inner tubular member 208b extends beyond the tip 209 of the outer tubular member 208a and seats below the opening in the outer tubular member 208a. Thus, a step transition is defined between the inner tubular member 208b and the outer tubular member 208a at the opening 210 in the end cap 208. This transition provides a surface for a shoulder 221 of the wire guide member 218 to dock with and thereby transmit a driving or pushing force to the end cap 208.

[0494] In a second configuration shown in FIGS. 31A and 31B, the end cap 208 includes a rounded tip 209. Thus, the tip 209 of the outer tubular member 208a is itself tapered or rounded. Providing a taper or flare to the tip 209 of the outer tubular member 208a may help provide an interference fit to maintain the inner tubular member 208b within the outer tubular member 208a. Additionally, the inner tubular member 208a includes a flared entrance 208c that defines the opening 210 and seats flush with the opening of the outer tubular member 208a. The flared entrance 208c has a shape complementary to the shoulder 221 of the wire guide member 218 to facilitate docking of the wire guide member 218 with the end cap 208.

[0495] In a third configuration, shown in Figures 32A and 32B, the inner tubular member 208b also includes a flared inlet 208c that seats flush with the opening of the outer tubular member 208a. However, in the third configuration, the inner tubular member 208a does not extend beyond the tip 209 of the outer tubular member 208a. Instead, the inner tubular member 208b abuts the inner surface of the tip 209 of the outer tubular member 209a. Thus, the tip of the end cap 208 is completely defined by the tip 209 of the outer tubular member 208a. Thus, the end cap 208 has a smooth tip 209 that passes through the leaflets 12 during implantation.

[0496] 33A and 33B show another alternative configuration of the end cap 208. FIG. 33A shows the end cap 208 in a first configuration in which the wire guide member 218 is not docked or engaged with the end cap 208. In the first configuration, the tip 209 of the end cap 208 is blunt or rounded. However, when the wire guide member 218 engages the end cap 208 through the opening 208, the tip 209 of the end cap 208 becomes pointed and is capable of puncturing the leaflets 12. Thus, in the configuration shown in FIG. 33A and 33B, the tip 209 of the end cap 208 is a retractable tip 209.

[0497] 34 illustrates another embodiment in which the wire guide member 218' is separate from the puncture wire member 219'. The puncture wire member 219' is positioned to pass through both the end cap 208 and the wire guide member 218'. The puncture wire member 219' is forced through the leaflet 12 to puncture it, and acts as a guide for the end cap 208 and the wire guide member 218' which engages the end cap 208. The wire guide member 218' thus acts to press the end cap 208 over the thinner puncture wire member 219' such that the end cap 208 and the arms 204 attached thereto pass through, and are thus embedded in, the leaflet 12.

[0498] 35A-35I show the soft tissue anchor system 200 at various stages during implantation within the valve leaflet 12. The illustrated soft tissue anchor system 200 includes an end cap 208 having a wire guide member 218 with a piercing section 219 therethrough, however, it will be readily appreciated that the general stages of implantation discussed herein are applicable to the various embodiments of the soft tissue anchor system 200 described herein.

[0499] First, the wire guide members 218 engage each end cap 208 of the soft tissue anchor system 200. The wire guide members 218 exert a force which results in piercing the leaflet 12 and pulling the arms 204 through the leaflet 12. In this embodiment, the piercing section 219 of the wire guide members 218 first pierces the leaflet 12 and the end caps 208 are pushed through the implantation site by the action of the control section 220. Figure 35A shows the arms 204 of the fabric anchor body 201 first passing through the leaflet 1 from the atrial side.

[0500] The wire guide member 218 is then manipulated so that the arms 204 pass completely through the leaflet 12, as shown in Figure 35B. The arms 204 pass completely through the leaflet 12 when the base 202 is seated adjacent to or in contact with the leaflet 12, as shown in Figures 35C and 35D. The narrow body 203 of the arms 204 is aligned with the leaflet 12 when the arms 204 are fully embedded therein.

[0501] Once the arms 204 are implanted into the leaflet 12 , the wire guide member 218 is withdrawn so that it is no longer engaged with the end cap 208 and is then guided back through the leaflet 12 via the implantation site of the arms 204 .

[0502] Tension T is then applied to tension line 214' by pulling on artificial line 214 with wire guide member 218 retracted. As shown in Figures 35C and 35D, artificial line 214 is secured to tension line 214' via a bridle knot 215. The bridle knot allows relative movement between artificial line 214 and tension line 214'. Tension T is applied in a direction outward from the surface of leaflet 12.

[0503] Application of tension T causes tension line 214' to be pulled back through leaflet 12. The position of knot 215 relative to leaflet 12 changes accordingly, resulting in knot 215 moving away from base 202 (as shown in FIG. 35E).

[0504] As tension line 214' retracts, it folds arm 204 towards base 202 such that leaflet 12 is sandwiched between folded arm 204 and base 202. The bellows motion of arm 204 is shown in Figures 35F-35H. Because tension line 214' is attached to end cap 208 via a central opening 211 formed in the wall of end cap 208 and arm 204 is joined to end cap 208 towards opening 210 for receiving wire guide member 218, end cap 208 is driven in a plane parallel to crease / surface 12b of leaflet 12, further aiding in folding arm 204 at the crease.

[0505] Finally, as shown in FIG. 35I, the folds of the arms 204 and the end caps 208 themselves lie in a plane parallel to the surfaces 12b of the leaflets 12.

[0506] Figures 36A-C are provided to illustrate various configurations of soft tissue anchor system 200 comprising a U-shaped fabric body 201. Figure 36A is a schematic diagram of soft tissue anchor system 200 and is provided as a useful juxtaposition to Figures 36B and 36C, which each show a prototype of soft tissue anchor system 200 comprising a U-shaped fabric body 201.

[0507] The U-shaped fabric body 201 can be formed from a single piece of fabric that defines arm portions 204, narrow body portion 203, and base portion 202, as shown in Figure 36B. To form base portion 202, a portion of fabric body 201 can be folded back onto itself, and a shape-retaining member 205 can optionally be sandwiched therebetween, as shown in Figure 36B.

[0508] 36C shows two prototype soft tissue anchor systems 200 according to an embodiment of the present invention. One anchor system 200 includes a shape-retaining member 205 (see prototype A) and the other does not (see prototype B). Prototype B is a shorter length of about 16 mm, while prototype A is longer. Thus, the length of the arm portion 204 can be varied during the manufacture of the U-shaped fabric body 201.

[0509] Figures 37A-37C show generally how a soft tissue anchor system 200 according to an embodiment of the invention may be received by and deployed from a catheter device. Although each of Figures 37A-37C shows only a proximal portion 1004 of a catheter device, it will be readily appreciated that such a proximal portion 1004 may be implemented within a catheter device as described in connection with any of Figures 1-24.

[0510] 37A shows the end cap 208 of the soft tissue anchor system 200 housed in a channel or groove 1208 for deployment from a proximal portion 1004 of a catheter device. The proximal portion 1004 functions as a gripper housing 1006, such that the channel 1208 faces the gripper arms 1030 such that the end cap 208 can be deployed from the channel 1208 by actuation of the respective wire guide members 218 once the leaflet 12 has been gripped by the gripper arms 1030, as shown in FIG.

[0511] The proximal portion 1004 of the catheter device also provides a housing 1201 for the U-shaped fabric body 201. Figure 37C shows the U-shaped fabric body 201 when housed in the housing 1201. The U-shaped fabric body housing 1201 also faces the gripper arms 1030 so that the U-shaped fabric body 201 can be embedded into the gripped leaflet 12.

[0512] The U-shaped fabric body 201 is disposed within a thin tubular sheath or curtain within the housing 1201. The sheath acts to reduce friction that the U-shaped fabric body 201 experiences from the housing 1201 during deployment of the soft tissue anchor system 200 from the catheter device. The sheath may flex or crumple during deployment to aid in the deployment of the fabric body 201.

[0513] The U-shaped fabric housing 1201 opens into a channel 1208 for the end cap 208 such that the arm portion 204 can extend between the end cap channel 1208 and the U-shaped fabric housing 1201. This configuration can thus facilitate smooth deployment of the soft tissue anchor system 200 from the proximal portion 1004 of the catheter device and into the grasped leaflet 12.

[0514] 38 shows a retrieval mechanism for a soft tissue anchor 200 comprising a U-shaped fabric body 201. The retrieval mechanism comprises a retrieval shaft 1300 and a snare 1302. The retrieval shaft is threaded over the artificial line 214 and the snare 1302 is used to capture the fabric body 201 by engaging the base portion 202. The snare 1302 can be a custom or pre-fabricated component. A fluorescent marker (not shown) is used to position the snare 1302. Once the base portion 202 is captured, tension is released on the tension line 214' so that the soft tissue anchor system 200 can be retrieved by pulling on the base portion 202, thereby deploying the arms 204 as they are pulled back through the leaflets 12.

[0515] 39A-39D show steps for retrieving the prototype soft tissue anchor system 20. When no tension is applied via tension line 214', base portion 202 is allowed to pull away from leaflet 12. As a result, arms 204 are pulled back through leaflet 12 and so deploy. Straightening arms 204 results in self-righting of end cap 208 so that end cap 208 extends collinear with arms 204, preferably perpendicular to surface 12b of leaflet 12. Finally, end cap 208 is moved back through leaflet 12.

[0516] 40 illustrates an alternative configuration of end cap 208 including pointed end 209. End cap 208 includes an outer tubular member 208a with an opening 211 formed in its wall for receiving tension line 214' and a notch 212 to facilitate attachment of end cap 208 to arm portion 204 of fabric body 201. Nested within outer tubular member 208a is inner tubular member 208b which defines an opening for receiving wire guide member 218.

[0517] The tip 209 includes a bevel surface 209a. The bevel surface 209a defines a surface on which the bevel of the tip 209 is formed. The tip 209 also includes two lancet surfaces 209b symmetrically disposed on either side of the bevel surface 209a. Such a configuration of the tip 209 can reduce the force required to puncture the leaflet 12 during implantation of the soft tissue anchor system 200, thereby reducing the trauma experienced during implantation.

[0518] 41 shows a top view of a prototypic soft tissue anchor system 200. The end cap 208 includes a pointed end 209, and the knot 215 used to secure the tension line 214' to the prosthetic line 215 is a locking knot 215, preventing the tension line 214' from moving relative to the prosthetic line 215. Although the soft tissue anchor system 200 according to this embodiment is provided without the shape-retaining member 205 and the stiffening element 206, in various embodiments such a soft tissue anchor system 200 may be provided with these features.

[0519] For each arm portion 204, tension lines 214' are threaded through holes 207' formed in arm portion 204, holes 207" formed in thin body portion 203, and holes 207"' formed in the base portion. This configuration, by locating hole 207" in thin body portion 203 with hole 207" oriented toward base portion 202, can encourage base portion 202 and arm portions 204 to collapse toward the soft body tissue, which can improve compression of fabric body 201 around the soft body tissue, thereby improving stability of soft tissue anchor system 200 during implantation.

[0520] 42 illustrates an alternative configuration of the end cap 208. In this configuration, the end cap 208 includes an outer tubular member 208a including a pointed end 209, an opening 211 for receiving a tension line 214', and a notch 212 for receiving an arm portion 204 of the fabric body 201. The end cap 208 also includes an inner tubular member 208b nested within the outer tubular member 208a. The inner tubular member 208b includes a flared entrance 208c that defines an opening 210 for receiving a wire guide member 218.

[0521] The outer tubular member 208a, in this embodiment, is configured to retain the inner tubular member 208b with a press fit. The end of the inner tubular member 208b distal to the flared inlet 208c is configured to mate with a complementary notch in the outer tubular member 208a such that the inner tubular member 208b is retained with an interference fit. Additionally, the flared inlet 208c of the inner tubular member 208b is positioned to abut an inner wall or surface of the outer tubular member 208a, thereby again reinforcing the press fit.

[0522] According to an embodiment of the present invention, the end cap 208 described above may be used by itself as part of the soft tissue anchor system 200. When the end cap 208 is used by itself as an anchor member, it may be considered as a tubular cap member 208. Thus, a soft tissue anchor system 200 according to the present invention may not necessarily be provided with a U-shaped fabric body 201, or may not be provided with a fabric body at all.

[0523] 43A-43D show soft tissue anchor system 200 including tubular cap member 208 and tension line 214' during various steps of implantation into valve leaflet 12. Although tubular cap member 208 shown in Figures 43A-43D and described herein has a structure as described in connection with Figure 42, it will be readily understood that the general principles and teachings of implantation of tubular cap member 208 are applicable to any of the end caps 208 described above.

[0524] In this embodiment, the soft tissue anchor system 200 includes only a single tubular cap member 208 and tension line 214' associated with the tubular cap member 208. However, in other embodiments, the tubular cap member 208 may be provided with a fabric body including an arm portion and a base portion. Multiple tubular cap members 208 may also be used as part of the same soft tissue anchor system without departing from the installation steps described in connection with Figures 43A-43D.

[0525] To embed the soft tissue anchor system 200 within the leaflet 12, a wire guide member 218 engages the tubular cap member 208 through the opening 210. The wire guide member 218 is then used to push the tubular cap member 208 into the leaflet 12 such that the tubular cap member 208 pierces the leaflet 12, as shown in FIG.

[0526] The wire guide member 218 continues to apply a driving force to the tubular cap member 208 such that the tubular cap member 208 passes completely through the valve leaflets 12, as shown in FIG. 43B.

[0527] The wire guide member 218 is then withdrawn, leaving the tubular cap member 208 suspended on the opposite side of the leaflet 12 from where it was implanted (see FIG. 43C). The tension line 214' remains extending through the implantation site 12c.

[0528] Finally, tension T is applied to tension line 214' in a direction outward from surface 12a in which tubular cap member 208 is embedded. As a result of the application of tension T, tubular cap member 208 extends in a plane parallel to leaflet surface 12b, and in this embodiment directly abuts this surface 12b, as shown in FIG.

[0529] As shown in FIG. 42 and FIG. 43A-D, the opening 211 from which the tension line 214′ extends is located closer toward the opening 210 for receiving the wire guide member 218, rather than toward the tip 209 of the tubular cap member 208. Toward the tip 209, the tubular cap member 208 has a smaller projected area due to being narrower. Thus, by positioning the tension line 214′ toward the opening 210 (where the tubular cap member 208 has a larger projected area due to being wider), the tubular cap member 208 may be able to contact the surface 12b of the leaflet 12 with an equal projected area on either side of the tension line 214′, resulting in a more stable abutment of the leaflet surface 12b with the tubular cap member 208.

[0530] FIG. 44 shows a wire guide member 218 for implanting an anchor member according to an embodiment of the present invention being received by an anchor member. In the illustrated embodiment, the anchor member is a tubular cap member 208. However, the anchor member may alternatively be an end cap 208 of an arm portion 204. The wire guide member 218 comprises a guide section, which in the embodiment shown here is a piercing section 219, and a control section 220. However, in other embodiments, the guide section may simply be a thinner wire section configured to be received by the tubular cap member 208 having a pointed end 209 for piercing soft tissue. The control section 220 is thicker than the piercing section 219. A bulge 221′ is provided between the control section 220 and the piercing section 219. The bulge 221′ is wider in diameter than both the control section 220 and the piercing section 219.

[0531] The bulge 221' is configured to engage with the flared entrance 208c of the tubular cap member 208 such that the wire guide member 218 can provide a driving force to the tubular cap member 208 during implantation of the soft tissue anchor system 200. The bulge 221' is also configured to engage with a complementary abutment 1021 located in a catheter device for implanting the soft tissue anchor system 200, as described below in connection with FIG.

[0532] Figure 45 shows a schematic representation of a deployment system 300 for implanting the soft tissue anchor system 200 in the valve leaflets 12. The deployment system 300 belongs to a catheter device 2, such as the catheter device of the form described in connection with any of Figures 1 to 24. The soft tissue anchor system 200 comprises a number of anchor members, which in the embodiment shown here are end caps 208 of the soft tissue anchor system 200 comprising a U-shaped fabric body 201. However, in other embodiments, they may be tubular cap members 208 as described in connection with Figures 43A-43D.

[0533] During delivery of the catheter device to an implantation site, such as a valve leaflet 12, the wire guide members 218 may undergo a curvature due to curvature of the delivery shaft of the catheter device. A first wire guide member 218 disposed toward the inside of the curvature experiences a first radius of curvature R1. A second wire guide member 218 disposed toward the outside of the curvature experiences a second, different radius of curvature R2. The second radius of curvature R2 is greater than the first radius of curvature R1. Thus, the second wire guide member 218 must traverse a greater distance than the first wire guide member 218 to reach the respective end cap 208.

[0534] In a preferred embodiment of the invention, each end cap 208 of a single fabric body 201 is simultaneously implanted into the soft body tissue 12. However, if one wire guide member 218 traverses a greater distance than the other, the end caps 208 do not necessarily have to be simultaneously implanted into the soft body tissue 12. Thus, in the embodiment shown here, the catheter device includes a deployment system 300 configured to simultaneously deploy each end cap 208 into the valve leaflets 12.

[0535] Deployment system 300 comprises a plurality of wire guide members 218 and an abutment 1021. Abutment 1021 acts to prevent each wire guide member 218 from being retracted more than a certain distance into the catheter device, and thus acts to provide an obstacle that limits proximal translation of wire guide member 218 by abutting bulge 221′ as wire guide member 218 is retracted proximally (i.e., into the delivery shaft).

[0536] The abutments 1021 are located at the proximal portion 1004 of the housing of the catheter device. They are therefore located after any possible deflection of the wire guide member 218 within the delivery shaft and can therefore restore the coplanar alignment of the wire guide member 218. The deployment system 300 of this embodiment also includes a spring device 230, which in this embodiment is located in the delivery handle of the catheter device, but may be located elsewhere in other embodiments. The spring device 230 is configured to bias the wire guide member 218 toward / in a proximal direction to the delivery shaft. Thus, the spring device 230 biases the bulge portion 221' toward the abutment portion 1021.

[0537] Regardless of the deflection of the wire guide members 218 within the delivery shaft, the wire guide members 218 are aligned coplanarly at their distal ends (i.e., the ends that engage with the end cap members 208), allowing the wire guide members 218 to move simultaneously with the same translational input to achieve simultaneous embedding of the end caps 208 with which they each engage.

[0538] 46A shows a soft tissue anchor system 200 implanted in a mitral valve leaflet 12 of a heart. The soft tissue anchor system 200 is implanted from the atrial side such that the base 202 of the soft tissue anchor system 200 is adjacent to the atrial surface of the leaflet 12. Thus, the lines 214, 214' of the soft tissue anchor system 200 descend beyond the free edge of the leaflet 12. The lines 214, 214 can provide support to the leaflet edges in this configuration.

[0539] 46B shows the soft tissue anchor system 200 from the ventricular side of the leaflet 12. The arms 204 are adjacent to the ventricular surface 12b of the leaflet 12, and the end cap 208 lies in a plane parallel to the ventricular surface 12b due to the line 214' being under tension.

[0540] FIG. 46B illustrates in more detail the tension acting on the lines 214, 214'. The tension line 214' can be considered to include multiple bridle lines. Each bridle line 214' is threaded through a respective arm 204 and connected to a respective end cap 208. Each bridle line 214' is then connected to be secured at a common bridle point 215, which as shown in FIG. 46B is a securement knot 215. The artificial line 214 is also connected to the bridle point 215 and extends in an outward direction from the leaflet 12.

[0541] A single tension F1 is applied to the artificial line 214. For ease of explanation, the tension F1 can be considered as the application of tension in a single vertical direction. The application of tension F1 places the bridle point 215 under tension. Because the bridle point 215 is connected to multiple bridle lines 214', this tension is also applied to each bridle line 214'. However, because the bridle point 215 provides a common location from which each bridle line 214' branches or branches, the resulting tension F2 acting on each bridle line 214' has a horizontal component and a vertical component. This is a result of the bridle point 215 distributing the tension F1 across each bridle line 214' and is a result of the overall Y-shaped configuration of the artificial line 214 and the tension line 214'.

[0542] As a result of tension F2 having a tension component perpendicular to the single tension F1 applied to the bridle point 215, the arms 204 and end cap 208 are subjected to a horizontally acting tension F3. This tension F3 acts to pull the arms 204 and end cap 208 toward a plane that intersects both the bridle point 215 and the direction in which the single tension F1 is applied. Thus, the arms 204 and end cap 208 may act to pinch and pull the tissue of the leaflet 12 together. Thus, the overall effect of tension F3 may "capture" excess tissue of the leaflet 12 located between the arms 204 and end cap 208, thereby restoring the shape of the leaflet 12 and / or providing additional structural support to the leaflet structure 12.

[0543] It has been found that the reshaping of the leaflet 12 tissue resulting from the capture of excess leaflet tissue as described above produces results similar to leaflet resection. Resection is a common surgical step in existing methods of heart valve repair, in which a surgeon resects a damaged section of the heart valve and sutures the remaining tissue edges together. Resection is often performed when excess leaflet tissue is present. However, by providing a line configuration including bridle points 215 and multiple bridle lines 214', the need for the resection step can be eliminated. This can simplify the overall surgical procedure.

[0544] The design of the fabric body 201 of the soft tissue anchor system 200 can be modified prior to manufacture, for example, by adjusting the dimensions of the base portion 202 and arm portions 204, or by adjusting the number of arm portions 204 and respective end caps 208 included in the design, to facilitate capture of the desired amount of leaflet tissue and therefore provide the appropriate "cutting" effect.

[0545] The following sections describe features and embodiments of the invention that may or may not be currently claimed in this application, but may form the basis of future claims, amendments or divisional applications.

[0546] 1. A soft tissue anchor system for implantation into soft body tissue to retain an artificial line, comprising: A U-shaped fabric body having a base portion and at least two arm portions extending from the base portion; means for folding each arm portion towards the base portion such that in use body tissue is sandwiched between the base portion and each arm portion; 1. A soft tissue anchor system comprising:

[0547] 2. The means for folding each arm portion toward the base portion includes a tension line passing through each of the arm portions and through the base portion; Item 1 , the soft tissue anchor system of claim 1 , wherein the tension line is configured to fold each arm portion toward the base portion when tension is applied to the tension line.

[0548] 3. The soft tissue anchor system of claim 2, wherein the tension line is fixed to each arm at the end of the arm distal to the base.

[0549] 4. Equipped with artificial lines, the artificial line is slidably joined to a portion of the tension line that is threaded through the base portion; 4. The soft tissue anchor system of claim 2 or 3, wherein the artificial line is configured to apply tension to the tension line.

[0550] 5. The soft tissue anchor system of claim 2, 3 or 4, wherein the fabric body comprises a reinforcing member.

[0551] 6. Each arm includes an end cap secured to an end of each arm distal to the base; 6. The soft tissue anchor system of any one of claims 1 to 5, wherein each end cap includes an opening configured to engage a wire guide member for embedding the U-shaped fabric body in body tissue.

[0552] 7. Each end cap comprises an outer tubular member and an inner tubular member, the outer tubular member configured to receive the inner tubular member; Item 7. The soft tissue anchor system of item 6, wherein the inner tubular member defines an opening configured to engage with the wire guide member.

[0553] 8. The inner tubular member includes a flared entrance defining an opening configured to engage the wire guide member; Optionally, the flared entrance is configured to mate with a corresponding portion of the wire guide member.

[0554] 9. The soft tissue anchor system of any of clauses 6, 7, or 8, wherein the outer tubular member includes a tapered portion located at the tip of the end cap.

[0555] 10. A soft tissue anchor system according to any one of paragraphs 6 to 9, wherein the tip of the end cap distal to the base portion is a blunt and / or rounded tip.

[0556] 11. A tip of the end cap distal to the base is a pointed tip configured to pierce body tissue; Optionally, the tip includes a beveled surface; or Optionally, the tip is a retractable tip such that the tip of the end cap is blunt and / or rounded at rest, and the tip becomes sharp when the wire guide member engages the end cap. A soft tissue anchor system as described in any of paragraphs 6 to 9.

[0557] 12. The outer tubular member includes a sidewall and an opening formed in the sidewall, the opening receiving the line; and / or Item 12. The soft tissue anchor system of any one of items 6 to 11, wherein the tension line is secured to each end cap by crimping, clamping, and / or sandwiching the tension line between the outer tubular member and the inner tubular member.

[0558] 13. A soft tissue anchor system according to any of paragraphs 6 to 12, wherein the tension lines are secured to each end cap in a central region and / or toward the tip of the end cap distal to the base portion.

[0559] 14. Each end cap is configured to extend collinearly with a respective arm portion during implantation and / or retrieval of the U-shaped fabric body; Item 14. The soft tissue anchor system of item 13, wherein each end cap is configured to extend parallel to the plane of each fold of the respective arm portion when tension is applied to the tension line.

[0560] 15. The soft tissue anchor system according to any one of claims 1 to 14, wherein the base portion defines the maximum width of the U-shaped fabric body.

[0561] 16. A soft tissue anchor system according to any one of items 1 to 15, wherein the base portion is provided with a shape-retaining member configured to increase the lateral rigidity of the base portion.

[0562] 17. The soft tissue anchor system is a leaflet anchor system for implantation into the cardiac valve leaflets to hold prosthetic chordae lines; Optionally, the heart valve is a mitral valve.

[0563] 18. A catheter device for implanting a soft tissue anchor system in cardiac tissue, 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; a soft tissue anchor system according to any one of claims 1 to 17 located within a housing compartment; A catheter device comprising:

[0564] 19. A catheter device as described in paragraph 18, comprising a wire guide member for deploying a soft tissue anchor system.

[0565] 20. The wire guide member includes a shoulder; 20. The catheter device of claim 19, wherein the housing section includes a stop configured to mate with the shoulder and thereby limit distal translation of the wire guide member within the housing section.

[0566] 21. A leaflet anchor for placement in a leaflet of a heart valve, the leaflet anchor being a soft tissue anchor according to any one of claims 1 to 20, the leaflet anchor being configured to be coupled to an artificial line; a leaflet anchor deployment mechanism for deploying the leaflet anchor and attaching it to the leaflet of the heart valve; Item 21. A catheter device according to item 20, comprising:

[0567] 22. A mechanical gripper device for gripping the leaflets of a heart valve; a leaflet anchor tube for housing the leaflet anchor prior to deployment in body tissue; Equipped with 22. The catheter device of claim 21, wherein the gripper device and the leaflet anchors are configured such that, in use, when the gripper device grips a leaflet, the leaflet anchor system can be pushed out of the leaflet anchor tube to puncture the leaflet and deploy the anchors to be embedded in the leaflet.

[0568] 23. The catheter device of claim 22, wherein the mechanical gripper device includes a gripper arm rotatably coupled to a body of the catheter device such that the gripper arm is configured to rotate relative to the catheter device to move an outer end of the gripper arm outwardly from the body of the catheter device.

[0569] 24. The catheter device of claim 23, wherein the gripper arm includes a slot formed in a base of the gripper arm, the gripper arm being rotatably coupled to the body via the slot such that the gripper arm is configured to translate outwardly from the body of the catheter device.

[0570] 25. A method for embedding the soft tissue anchor system according to any one of items 1 to 17 into soft body tissue, comprising: engaging each arm portion with a respective wire guide member; pushing each arm into body tissue using a respective wire guide member; withdrawing each respective wire guide member; folding each arm portion toward the base portion such that the body tissue is sandwiched between the base portion and each arm portion; A method comprising:

[0571] 26. A soft tissue anchor system for implantation into soft body tissue to retain a line, comprising: A U-shaped fabric body having a base portion and at least two arm portions extending from the base portion; means for folding each arm portion towards the base portion such that in use body tissue is sandwiched between the base portion and each arm portion; 1. A soft tissue anchor system comprising:

[0572] 27. The soft tissue anchor system of claim 26, wherein each arm includes an end cap secured to an end of the arm distal to the base, each end cap configured to receive a wire guide member for implanting the anchor in body tissue and to pull the arm through body tissue during implantation.

[0573] 28. A soft tissue anchor system for implantation into soft body tissue to retain a line, comprising: A fabric body including a base portion and at least one arm portion extending from the base portion; means for folding each arm towards the base such that, in use, body tissue is sandwiched between the base and each arm; Equipped with A soft tissue anchor system, wherein each arm includes an end cap secured to an end of each arm distal to the base, each end cap configured to receive a wire guide member for implanting the anchor in body tissue and for pulling the arm through the body tissue during implantation.

[0574] 29. The soft tissue anchor system of claim 28, wherein the fabric body is a U-shaped fabric body having a base portion and at least two arm portions extending from the base portion.

[0575] 30. The soft tissue anchor system of claim 27, 28, or 29, wherein each end cap has an opening configured to receive a wire guide member, the openings being located at an end of the end cap proximal to the arm portion.

[0576] 31. A soft tissue anchor system according to any of paragraphs 27 to 30, wherein each end cap has a pointed tip at an end of the end cap distal to the arm portion, the pointed tip being configured to pierce body tissue.

[0577] 32. The end cap is made from a resilient material and is configured to move from a rest configuration to an engaged configuration upon receiving the wire guide member; In the rest configuration, the tips are retracted such that the ends of the end caps distal to the arms are blunt; 32. The soft tissue anchor system of claim 31, wherein in the engaged configuration, the pointed portion extends such that the end of the end cap distal to the arm portion is pointed.

[0578] 33. A soft tissue anchor system according to any of paragraphs 27 to 29, wherein each end cap includes a hollow conduit extending therethrough, the hollow conduit being configured to receive a puncture wire guide member for embedding the anchor in body tissue.

[0579] 34. The hollow conduit comprises a first portion proximal to the arm and a second portion distal to the arm; a radius of the first portion is greater than a radius of the second portion, and a shoulder is defined between the first portion and the second portion; Item 34. The soft tissue anchor system of item 33, wherein the hollow conduit is configured to receive a penetrating wire guide member, the shoulder is configured to dock with the penetrating wire guide member, and the second portion is configured to allow the penetrating tip of the penetrating wire guide member to pass through.

[0580] 35. A soft tissue anchor system according to any one of paragraphs 27 to 30, 33 and 34, wherein the tip of the end cap distal to the arm portion is blunt and / or rounded.

[0581] 36. Each end cap is configured to extend colinearly with the arm portion when receiving a wire guide member; Item 36. The soft tissue anchor system of any one of items 27 to 35, wherein each end cap is configured to be positioned substantially flush with each fold of the respective arm portion when the arm portion is folded.

[0582] 37. The means for folding each arm portion includes a respective line and / or a respective portion of a line passing through each arm portion and the base portion; Each line and / or portion of a line is fixed to an end of a respective arm distal to the base; Item 37. The soft tissue anchor system of any of items 26 to 36, wherein each line and / or portion of the line is configured to fold the respective arm portion toward the base portion when tension is applied to the line and / or portion of the line.

[0583] 38. The anchoring system of paragraph 37, wherein the fabric body includes a backbone portion embedded therein, the backbone portion defining holes in the arm portions through which respective portions of the line are threaded.

[0584] 39. The anchor system according to any one of items 26 to 38, wherein the anchor is a leaflet anchor for implantation into the mitral valve leaflet to hold an artificial chordae line.

[0585] 40. The anchor system of any one of paragraphs 26 to 39, wherein the base portion has a wire frame embedded therein, the base portion defining the widest portion of the pledget.

[0586] 41. A method for embedding the anchor system according to any one of items 26 to 40, pushing each arm into body tissue using a respective wire guide member; withdrawing each respective wire guide member; folding each arm portion toward the base portion such that the body tissue is sandwiched between the base portion and each arm portion; A method comprising:

[0587] 42. A soft tissue anchor system for implantation into soft tissue to secure an artificial line, comprising: Line, A tubular cap member; Equipped with A soft tissue anchor system, wherein an end of the line is secured to the tubular cap member and extends from a central portion thereof such that, in use, the tubular cap member is configured to extend in a plane parallel to a surface of the soft body tissue when implanted in the soft body tissue and to extend under tension of the line as it passes through the tissue in a direction outward from that surface, the tubular cap member comprising an opening configured to receive a wire guide member for passing the tubular cap member through the soft body tissue during implantation.

[0588] 43. A tubular cap member comprising an outer tubular member and an inner tubular member, the outer tubular member being configured to receive the inner tubular member; 43. The soft tissue anchor system of claim 42, wherein the inner tubular member defines an opening configured to receive the wire guide member.

[0589] 44. The soft tissue anchor system of claim 43, wherein the inner tubular member includes a flared entrance defining an opening configured to receive the wire guide member.

[0590] 45. The soft tissue anchor system of claim 44, wherein the flared entrance is configured to mate with a corresponding portion of the wire guide member.

[0591] 46. ​​The outer tubular member includes a sidewall and an opening formed in the sidewall, the opening receiving the line; 46. ​​The soft tissue anchor system of claim 43, 44 or 45, wherein the end of the line is secured to the tubular cap member between the outer tubular member and the inner tubular member.

[0592] 47. A soft tissue anchor system described in any of paragraphs 42 to 26, wherein the tubular cap member includes a pointed end configured to puncture body tissue, the pointed end being disposed at an end of the tubular cap member distal to an opening configured to receive a wire guide member.

[0593] 48. The soft tissue anchor system of claim 47, wherein the tip includes a beveled surface.

[0594] 49. A soft tissue anchor system described in any of paragraphs 42 to 46, wherein the tubular cap member has a blunt and / or rounded tip, the blunt and / or rounded tip being located at an end of the tubular cap member distal to an opening configured to receive a wire guide member.

[0595] 50. A fabric body having a base portion and an arm portion extending from the base portion, the arm portion is configured to be folded toward the base portion such that, in use, body tissue is sandwiched between the base portion and the arm portion; Item 50. The soft tissue anchor system according to any one of items 42 to 49, wherein the tubular cap member is fixed to an end of the arm portion distal to the base portion.

[0596] 51. The arm portion is configured to be folded toward the base portion by the action of a line passing through the arm portion and the base portion; Item 51. The soft tissue anchor system of any one of items 42 to 50, wherein the line is configured to fold the arm portion toward the base portion when tension is applied to the line.

[0597] 52. The tubular cap member is configured to extend collinearly with the arm portion during implantation and / or retrieval of the fabric body; 52. The soft tissue anchor system of claim 50 or 51, wherein the tubular cap member is configured to extend parallel to the plane of each fold of the arm portion when tension is applied to the line.

[0598] 53. The fabric body is a U-shaped fabric body having a base portion and at least two arm portions extending from the base portion; 53. The soft tissue anchor system of claim 50, 51 or 52, wherein each arm includes a tubular cap member secured to an end of the arm distal to the base.

[0599] 54. A soft tissue anchor system according to any one of claims 42 to 53, wherein the base portion defines the maximum width of the U-shaped fabric body.

[0600] 55. A soft tissue anchor system according to any one of items 42 to 54, wherein the line is an artificial line.

[0601] 56. Equipped with artificial lines, the artificial line is joined to a portion of the line distal to the end fixed to the central portion; Item 55. The soft tissue anchor system according to any one of items 42 to 54, wherein the artificial line is configured to apply tension to the line.

[0602] 57. A plurality of tubular cap members are provided; the tension line comprises a plurality of bridle lines, each bridle line being associated with a respective tubular cap member; Item 58. The soft tissue anchor system of any of items 42 to 57, wherein each bridle line is connected to a common bridle point, the bridle point being configured to place each bridle line under tension when it passes through the soft body tissue in a direction outward from the surface of the tissue and when the bridle point is itself under tension.

[0603] 58. A soft tissue anchor system according to any one of items 42 to 57, which is a valve leaflet anchor system for implantation into a heart valve leaflet to secure an artificial chord line.

[0604] 59. A catheter device for implanting a soft tissue anchor system in cardiac tissue, 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; A soft tissue anchor system according to any one of items 42 to 58, located within a housing compartment; A catheter device comprising:

[0605] 60. The soft tissue anchor system includes a plurality of tubular cap members, and the catheter device includes a deployment system configured to simultaneously implant each of the tubular cap members into cardiac tissue; The deployment system includes a plurality of wire guide members, each wire guide member including a guide portion located at a distal end thereof and configured to engage a respective tubular cap member; Item 60. The catheter device of item 59, wherein the deployment system is configured to maintain coplanar alignment between the guide portions of the multiple wire guide members during implantation of the tubular cap member.

[0606] 61. Each wire guide member has a bulge portion; 61. A catheter device as described in paragraph 60, wherein each wire guide member is movable between a first configuration and a second configuration, and in the first configuration the bulge is configured to engage with a first obstacle configured to limit translation of the wire guide member in a proximal direction, and in the second configuration the wire guide member is configured to engage with a respective tubular cap member.

[0607] 62. The catheter device described in paragraph 61, wherein the first obstacle is an abutment located in the proximal portion of the housing section.

[0608] 63. The catheter device of paragraph 61 or 62, wherein in the second configuration, the bulge is configured to abut a complementary portion of the tubular cap member.

[0609] 64. The catheter device of paragraphs 61, 62 or 63, wherein the deployment system includes a spring device configured to bias each wire guide member into the first configuration.

[0610] 65. A catheter device as described in paragraph 59, comprising a wire guide member that engages the opening.

[0611] 66. The wire guide member includes a shoulder; Item 66. The catheter device of item 65, wherein the housing section includes a stop configured to mate with the shoulder and thereby limit distal translation of the wire guide member within the housing section.

[0612] 67. A leaflet anchor for placement in a leaflet of a heart valve, the leaflet anchor being a soft tissue anchor according to any one of claims 1 to 66, the leaflet anchor being configured to be coupled to an artificial line; a leaflet anchor deployment mechanism for deploying the leaflet anchor and attaching it to the leaflet of the heart valve; Item 67. The catheter device according to any one of Items 59 to 66, comprising:

[0613] 68. A mechanical gripper device for gripping the leaflets of a heart valve; a leaflet anchor tube for housing the leaflet anchor prior to deployment in body tissue; Equipped with Item 68. The catheter device of item 67, wherein the gripper device and leaflet anchor are configured such that, in use, when the gripper device grips a leaflet, the leaflet anchor system can be pushed out of the leaflet anchor tube to puncture the leaflet and deploy the anchor to be embedded in the leaflet.

[0614] 69. A catheter device as described in paragraph 68, wherein the mechanical gripper device includes a gripper arm rotatably coupled to the body of the catheter device, such that the gripper arm is configured to rotate relative to the catheter device to move an outer end of the gripper arm outwardly from the body of the catheter device.

[0615] 70. The catheter device of claim 69, wherein the gripper arm includes a slot formed in a base of the gripper arm, the gripper arm being rotatably coupled to the body via the slot such that the gripper arm is configured to translate outwardly from the body of the catheter device.

[0616] 71. A method for implanting a soft tissue anchor system according to any one of paragraphs 42 to 58, engaging a tubular cap member with a wire guide member; pushing the tubular cap member through the body tissue using the wire guide member; withdrawing the wire guide member; applying tension to the line as it passes through the tissue in an outward direction from the surface thereof so that the tubular cap member seats against the soft body tissue; A method comprising:

[0617] 72. A method for producing a soft tissue anchor system according to any one of paragraphs 42 to 58, comprising: Creating a tubular cap member; fastening the line to the tubular cap member with the line extending from a central portion of the tubular cap member; A method comprising:

[0618] 73. A soft tissue anchor system for implantation into soft body tissue to retain an artificial line, the anchor comprising: A U-shaped fabric body having a base portion and at least two arm portions extending from the base portion, A soft tissue anchor system, wherein each arm is configured to fold toward the base such that, in use, body tissue is sandwiched between the base and each arm.

Claims

1. 1. A soft tissue anchor system for implantation in soft body tissue to retain an artificial line, said anchor comprising: A U-shaped fabric body having a base portion and at least two arm portions extending from the base portion, A soft tissue anchor system, wherein each arm portion is configured to fold toward the base portion such that, in use, the body tissue is sandwiched between the base portion and each arm portion.

2. a tension line passing through the arm portion and the base portion; 10. The soft tissue anchor system of claim 1, wherein the tension line is configured to fold each arm portion toward the base portion when tension is applied to the tension line.

3. 3. The soft tissue anchor system of claim 2, wherein the tension line is secured to each arm at an end of the arm distal to the base.

4. 3. The soft tissue anchor system of claim 2, wherein the tension line is threaded through the arm portion and the base portion only four times.

5. the tension line includes a plurality of bridle lines, each bridle line associated with a respective arm; 3. The soft tissue anchor system of claim 2, wherein each bridle line is connected to a common bridle point, the bridle point configured to place each bridle line under tension when a tension force is applied to the bridle point.

6. The artificial line is provided, The soft tissue anchor system of claim 2 , wherein the artificial line is configured to apply the tension.

7. each arm including an end cap secured to an end of each arm distal to the base; The soft tissue anchor system of any one of claims 1 to 6, wherein each end cap includes an opening configured to engage a wire guide member for implanting the U-shaped fabric body into the body tissue.

8. Each end cap comprises an outer tubular member and an inner tubular member, the outer tubular member configured to receive the inner tubular member; The soft tissue anchor system of claim 7 , wherein the inner tubular member defines the opening configured to engage the wire guide member.

9. the inner tubular member includes a flared entrance defining the opening configured to engage the wire guide member; 8. The soft tissue anchor system of claim 7, optionally wherein the flared entrance is configured to mate with a corresponding portion of the wire guide member.

10. the outer tubular member includes a sidewall and an opening formed in the sidewall; the opening receives the tension line; and / or 8. The soft tissue anchor system of claim 7, wherein an end of the tension line is secured to each end cap between the outer tubular member and the inner tubular member.

11. a tip of the end cap distal to the base portion is a pointed tip configured to pierce the body tissue; 8. The soft tissue anchor system of claim 7, optionally wherein the pointed end comprises a beveled surface.

12. each end cap configured to extend collinearly with a respective arm portion during implantation and / or retrieval of the U-shaped fabric body; 8. The soft tissue anchor system of claim 7, wherein each end cap is configured to extend parallel to a plane of each fold of the respective arm when tension is applied to the tension line.

13. 10. The soft tissue anchor system of claim 1, wherein the base portion defines a maximum width of the U-shaped fabric body.

14. 10. The soft tissue anchor system of claim 1, wherein the U-shaped fabric body comprises a narrow body portion extending between the base portion and each arm portion.

15. 10. The soft tissue anchor system of claim 1, wherein the soft tissue anchor system is a leaflet anchor system for implantation in a heart valve leaflet to retain an artificial chordae line.

16. 1. A catheter device for implanting a soft tissue anchor system in cardiac tissue, comprising: a housing section extending from the distal end of the catheter device along the length of the catheter device toward the proximal end of the catheter device; a soft tissue anchor system according to claim 1 located within the housing compartment; A catheter device comprising:

17. each arm includes an end cap secured to an end of each arm distal to the base, each end cap including an opening configured to engage a wire guide member for implanting the U-shaped fabric body into the body tissue; a deployment system configured to simultaneously implant each of the end caps into the cardiac tissue; the deployment system includes a plurality of wire guide members, each wire guide member including a guide portion located at a distal end thereof and configured to engage a respective end cap; 17. The catheter device of claim 16, wherein the deployment system is configured to maintain coplanar alignment between the guide portions of the plurality of wire guide members during implantation of the end cap.

18. Each wire guide member includes a bulge portion; 18. The catheter device of claim 17, wherein each wire guide member is movable between a first configuration and a second configuration, wherein in the first configuration the bulge is configured to engage a first obstruction configured to limit proximal translation of the wire guide member, and in the second configuration the wire guide member is configured to engage a respective end cap.

19. the first obstruction is an abutment located at a proximal portion of the housing section; and / or In the second configuration, the bulge is configured to abut a complementary portion of the end cap; and / or 20. The catheter device of claim 18, wherein the deployment system comprises a spring device configured to bias each wire guide member into the first configuration.

20. 17. The catheter device of claim 16, comprising a wire guide member for deploying the soft tissue anchor system.

21. the wire guide member includes a shoulder; 21. The catheter device of claim 20, wherein the housing section includes a stop configured to mate with the shoulder and thereby limit distal translation of the wire guide member within the housing section.

22. a leaflet anchor for placement in a leaflet of a heart valve, the leaflet anchor being the soft tissue anchor system, the leaflet anchor being configured to be coupled to the prosthetic line; and a leaflet anchor deployment mechanism for deploying and attaching the leaflet anchor to the leaflet of the heart; 17. The catheter device of claim 16, comprising:

23. a mechanical gripper device for gripping the leaflets of the heart valve; a leaflet anchor tube for housing the leaflet anchor prior to deployment within the body tissue; Equipped with 23. The catheter device of claim 22, wherein the gripper device and the leaflet anchors are configured such that, in use, when the gripper device grips the valve leaflet, the leaflet anchor system can be pushed out of the leaflet anchor tube to puncture the valve leaflet and deploy the anchors to be embedded in the valve leaflet.

24. 24. The catheter device of claim 23, wherein the mechanical gripper device includes a gripper arm rotatably coupled to a body of the catheter device such that the gripper arm is configured to rotate relative to the catheter device to move an outer end of the gripper arm outward from the body of the catheter device.

25. 25. The catheter device of claim 24, wherein the gripper arm includes a slot formed in a base of the gripper arm, the gripper arm being rotatably coupled to the body via the slot such that the gripper arm is configured to translate outwardly from the body of the catheter device.

26. 10. A method of implanting the soft tissue anchor system of claim 1 into soft body tissue, comprising: engaging each arm portion with a respective wire guide member; pushing each arm portion into the body tissue using the respective wire guide member; withdrawing each respective wire guide member; folding each arm portion toward the base portion such that the body tissue is sandwiched between the base portion and each arm portion; A method comprising:

27. 10. A method of manufacturing the soft tissue anchor system of claim 1, comprising: Producing the U-shaped fabric body; Each arm portion is configured to be foldable. A method comprising:

28. 28. The method of claim 27, wherein the step of producing the U-shaped fabric body comprises laser cutting fabric.

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