CN116801838A - Tissue remodeling systems and methods - Google Patents

Abstract

Systems and methods for remodeling tissue, such as heart tissue. In some configurations, the systems and methods involve reshaping a mitral valve of a patient. The system and method may include a first tissue anchor, a second tissue anchor, a suture extending between the tissue anchors, and a suture lock securing the suture or securing a length of the suture relative to at least one of the tissue anchors. The system and method may further comprise a suture trimmer capable of trimming excess portions of the suture. In some configurations, the suture lock is reversible to allow for iterative adjustment of the remodeling. In some configurations, the tissue anchor includes one or more features, such as one or more barbs, to inhibit removal of the tissue anchor from an implantation site within tissue.

Description

Tissue remodeling systems and methods

Technical Field

The present disclosure relates to systems and methods for remodeling tissue. In particular, the present disclosure relates to systems and methods for heart valve remodeling (such as mitral valve remodeling).

Description of the Related Art

A heart valve is located at the outlet of each of the four ventricles. The heart valve operates as a one-way valve to prevent blood flow in the wrong direction. Each valve has a set of petals, called leaflets or cusps. Valve regurgitation is when blood leaks through an incompletely closed valve, allowing blood to flow in both directions during contraction. Regurgitation may be caused by abnormalities in the valve leaflet itself (known as primary regurgitation), such as valve prolapse, damaged chordae, rheumatic fever, endocarditis, trauma, or congenital heart defects. On the other hand, in secondary regurgitation, the valve itself is intact, and only the surrounding structure of the valve leaflet insertion is abnormal, resulting in regurgitation. Examples of secondary reflux are history of heart attacks, cardiomyopathy, prolonged use of certain drugs, radiation, atrial fibrillation, etc. Regurgitation may lead to congestive heart failure, the most common hospitalization diagnosis in the united states. Symptoms of congestive heart failure include fatigue, shortness of breath, swelling of the feet and legs. Valve regurgitation results in a vicious circle of heart failure, arrhythmia and exacerbation of cardiomyopathy (heart muscle weakness), resulting in more regurgitation.

Historically, open surgical valve repair or replacement has been used to treat diseases such as regurgitation. Recently, catheter-based techniques have been developed and introduced into the clinical practice of mitral valve repair. In general, repair is believed to be superior to valve replacement to restore leaflet coaptation.

Disclosure of Invention

The systems, methods, and devices described herein have innovative aspects, none of which are indispensable or solely responsible for their desirable attributes. Without limiting the scope of the claims, some advantageous features will now be summarized.

One aspect of the present disclosure relates to a system for mitral valve remodeling that includes a first tissue anchor and a second tissue anchor. The first tissue anchor is configured to be implanted into tissue at a first location at or near an annulus of a mitral valve of a patient. The first tissue anchor includes an anchor portion, a driving portion, and a suture mounting portion. The anchor portion engages tissue and is implanted by rotation about a longitudinal axis of the first tissue anchor. The drive portion is rotatably fixed relative to the anchor portion and is configured to removably engage with a drive member of the catheter. The suture mounting portion is rotatable relative to the anchor portion and the drive portion and is located between the drive portion and the anchor portion along the longitudinal axis. The second tissue anchor is configured to be implanted in tissue at a second location opposite the first location at or near the annulus of the mitral valve. The second tissue anchor includes an anchor portion, a driving portion, and a suture mounting portion. The anchor portion engages tissue and is implanted by rotation about a longitudinal axis of the second tissue anchor. The drive portion is rotatably fixed relative to the anchor portion and is configured to removably engage with a drive member of the catheter. The suture mounting portion is rotatable relative to the anchor portion and the drive portion and is located between the drive portion and the anchor portion along the longitudinal axis. The suture has a tensioning portion extending between a first suture mounting location on the suture mounting portion of the first tissue anchor and a second suture mounting location on the suture mounting portion of the second tissue anchor. The suture mounting portions of the first and second tissue anchors rotate to align with each other in response to tension applied to the suture.

In one embodiment, each of the first and second suture mounting locations of the first and second tissue anchors includes a channel that receives a suture, with a tensioning portion of the suture extending from an end of the channel that is relatively closer to the anchor portion.

In one embodiment, the suture lock is configured to fix a portion of the suture relative to the second tissue anchor to fix a length of a tensioned portion of the suture between the first tissue anchor and the second tissue anchor.

In one embodiment, a suture lock includes a first portion and a second portion movable relative to the first portion, wherein a locking portion of a suture is captured between the first portion and the second portion.

In one embodiment, the first portion includes a channel, wherein the locking portion of the suture passes through the channel.

In one embodiment, the first portion of the suture lock is configured to contact a suture mounting portion of the second tissue anchor to secure a length of a tensioning portion of the suture.

In one embodiment, when the suture lock is in contact with the second tissue anchor, the passage of the suture lock is aligned with the passage of the second suture mounting location of the second tissue anchor.

In one embodiment, the first portion of the suture lock is rotationally fixed relative to the second portion.

In one embodiment, the threaded fastener is configured to move the first portion of the suture lock relative to the second portion.

In one embodiment, the threaded fastener is configured to move the first portion of the suture lock toward and away from the second portion.

In one embodiment, the suture cutter is configured to cut a suture.

In one embodiment, the suture cutter includes a tip having an axial slot and a radial passage, wherein the axial slot intersects the radial passage, wherein the suture passes through the radial passage, and a blade movable within the slot to cut the suture.

In one embodiment, the anchor portion includes one or more barbs.

In one embodiment, each of the barbs includes a tubular element having an angled end with a tip positioned radially outward.

One aspect of the present disclosure relates to a system for implanting a tissue anchor into cardiac tissue of a patient. The system includes a delivery catheter including an anchor delivery tip. The tip includes a fixed portion and a rotatable portion. The fixation portion includes a suture channel having a first end and a second end. The rotatable portion includes a drive portion. The system also includes a tissue anchor including an anchor portion, a driving portion, and a suture mounting portion. The anchor portion engages heart tissue and is implanted by rotation about a longitudinal axis of the tissue anchor. The drive portion is rotatably fixed relative to the anchor portion and is configured to removably engage the drive portion of the catheter. The suture mounting portion is rotatable relative to the anchor portion and the drive portion. The suture is secured to the suture mounting portion. The tissue anchor is configured to engage the delivery catheter, and a driving portion of the tissue anchor engages the driving portion of the delivery catheter. The suture extends through a suture channel of the distal end of the delivery catheter such that the suture can be tensioned to prevent rotation of a suture mounting portion of the tissue anchor when the rotatable portion of the distal end of the delivery catheter is rotated to rotate the driving portion and the anchor portion of the tissue anchor, thereby implanting the tissue anchor in cardiac tissue.

In one embodiment, the suture channel of the fixed portion is located radially outward of the rotatable portion.

In one embodiment, the suture mounting portion is located between the driving portion and the anchor portion.

In one embodiment, the delivery catheter includes a distal tip cap configured to surround the tissue anchor prior to deployment.

In one embodiment, the distal tip cap includes a slot through which the suture passes from the exterior of the distal tip cap to the interior of the distal tip cap, enabling the suture to be secured to the suture mounting portion.

In one embodiment, the distal tip cap includes a slit extending from the slot to a distal end of the distal tip cap, wherein the slit is configured such that the suture can move from the slot, through the slit, and separate from the distal tip cap when the tissue anchor is deployed from the delivery catheter.

In one embodiment, the anchor portion includes one or more barbs.

In one embodiment, each of the barbs includes a tubular element having an angled end with a tip positioned radially outward.

One aspect of the present disclosure relates to a tissue anchor comprising an anchor portion comprising a helical thread configured to be implanted in body tissue by rotation about a longitudinal axis of the tissue anchor. The tissue anchor further includes a driving portion rotatably fixed relative to the anchor portion. The drive portion is configured to removably engage with the drive member of the catheter such that rotation of the drive member rotates the drive portion and the anchor portion of the tissue anchor. The tissue anchor further includes a suture mounting portion rotatable relative to the anchor portion and the drive portion. The suture mounting portion is configured to be connected to a suture at a suture mounting location. The suture mounting portion is configured to rotate to align the suture mounting location with a direction of a force of the suture. The suture mounting portion is located between the drive portion and the anchor portion along the longitudinal axis.

In one embodiment, the helical thread of the anchor portion is a helical coil defining a hollow interior space.

In one embodiment, the helical coil comprises a circular cross-sectional shape.

In one embodiment, the drive portion defines a radially outwardly facing drive surface configured to engage a drive member of the catheter.

In one embodiment, the drive portion includes a square cross-sectional shape defining a radially outwardly facing drive surface.

In one embodiment, the suture mounting portion has a peripheral surface about a longitudinal axis of the tissue anchor, the peripheral surface defining a geometric center of the suture mounting portion, wherein the rotational axis of the suture mounting portion is spaced from the geometric center.

In one embodiment, the suture mounting locations are located on opposite sides of the geometric center from the rotational axis.

In one embodiment, the suture mounting location includes a passage extending through the suture mounting portion in a direction substantially aligned with a longitudinal axis of the tissue anchor.

In one embodiment, the length of the anchor portion along the longitudinal axis is greater than the length of one or both of the drive portion and the suture mounting portion.

In one embodiment, the length of the driving portion is greater than the length of the suture mounting portion.

In one embodiment, the anchor portion includes one or more barbs.

In one embodiment, each of the barbs includes a tubular element having an angled end with a tip positioned radially outward.

One aspect of the present disclosure relates to a tissue anchor comprising an anchor portion comprising a helical thread configured to be implanted in body tissue by rotation about a longitudinal axis of the tissue anchor. The tissue anchor further includes a driving portion rotatably fixed relative to the anchor portion. The drive portion is configured to removably engage with the drive member of the catheter such that rotation of the drive member rotates the drive portion and the anchor portion of the tissue anchor. The tissue anchor further includes a suture mounting portion rotatable relative to the anchor portion and the drive portion. The suture mounting portion is configured to be connected to a suture at a suture mounting location. The suture mounting portion is configured to rotate to align the suture mounting location with a direction of a force of the suture. The suture mounting portion is located above the anchor portion along the longitudinal axis. The suture mounting portion has a first end surface and a second end surface opposite the first end surface. The second end surface is closer to the anchor portion than the first end surface along the longitudinal axis. The suture mounting portion is configured such that the suture extends from the tissue anchor at or below the second end surface.

In one embodiment, the suture mounting portion is positioned proximate to the anchor portion.

In one embodiment, the helical thread of the anchor portion is a helical coil defining a hollow interior space.

In one embodiment, the helical coil comprises a circular cross-sectional shape.

In one embodiment, the drive portion defines a radially outwardly facing drive surface configured to engage a drive member of the catheter.

In one embodiment, the drive portion includes a square cross-sectional shape defining a radially outwardly facing drive surface.

In one embodiment, the suture mounting portion has a peripheral surface about a longitudinal axis of the tissue anchor, the peripheral surface defining a geometric center of the suture mounting portion, wherein the rotational axis of the suture mounting portion is spaced from the geometric center.

In one embodiment, the suture mounting locations are located on opposite sides of the geometric center from the rotational axis.

In one embodiment, the suture mounting location includes a passage extending through the suture mounting portion from the first end surface to the second end surface in a direction substantially aligned with the longitudinal axis of the tissue anchor.

In one embodiment, the length of the anchor portion along the longitudinal axis is greater than the length of one or both of the drive portion and the suture mounting portion.

In one embodiment, the length of the driving portion is greater than the length of the suture mounting portion.

In one embodiment, the anchor portion includes one or more barbs.

In one embodiment, each of the barbs includes a tubular element having an angled end with a tip positioned radially outward.

One aspect of the present disclosure relates to a suture lock for a tissue remodeling system. The suture lock includes a first portion including a base flange and a hub extending in an axial direction from the base flange. The base flange includes a suture channel configured to receive a suture of a tissue remodeling system. The suture lock also includes a second portion including an end wall and at least one sidewall defining a space to slidably engage the hub of the first portion. The end wall and the at least one side wall are configured to prevent rotation of the first portion when the hub is positioned within the space. The second portion further includes a clamping surface positioned adjacent an end of the suture channel of the base flange and configured to clamp a portion of the suture against the base flange to lock the suture relative to the suture lock. The second portion is movable toward and away from the first portion to selectively clamp and release the suture.

In one embodiment, the at least one sidewall includes a first sidewall and a second sidewall, wherein the first sidewall and the second sidewall are parallel and spaced apart from each other to receive the hub therebetween.

In one embodiment, the first portion includes a threaded cavity extending in an axial direction within the hub and the second portion includes an opening in the end wall, the suture lock further including a threaded fastener passing through the opening and threadably engaging the threaded cavity, wherein the threaded fastener is configured to move the first portion toward the second portion in response to rotation in the first direction and to allow the first portion to move away from the second portion in response to rotation in the second direction.

One aspect of the present disclosure relates to a method of reshaping a mitral valve. The method includes implanting a first tissue anchor at a first location at or near an annulus of a mitral valve of a patient using at least one catheter. The method further includes implanting a second tissue anchor at a second location opposite the first location at or near an annulus of a mitral valve of the patient using the at least one catheter. The method further includes extending a suture between the first tissue anchor and the second tissue anchor and moving the first tissue anchor and the second tissue anchor toward each other using the suture. The method includes securing a tensioned length of suture between a first tissue anchor and a second tissue anchor using a suture lock capable of locking using at least one catheter. The method further includes observing the function of the mitral valve and, if desired, unlocking the suture lock, increasing or decreasing the suture tension length, and relocking the suture lock.

In one embodiment, the method further comprises cutting the excess portion of the suture using a suture cutter.

One aspect of the present disclosure relates to a method of tensioning a suture of a mitral valve remodeling system. The method includes slidably engaging a suture lock with a suture, an end of the suture secured to a first tissue anchor implanted at a first location at or near the annulus of the mitral valve and slidably engaged with a second tissue anchor implanted at a second location at or near the annulus of the mitral valve. The method further includes sliding the suture lock along the suture toward the second tissue anchor using the catheter until the suture lock contacts the second tissue anchor. The method further includes applying a pulling force to the suture while holding the suture lock in contact with the second tissue anchor to tension a portion of the suture extending between the first tissue anchor and the second tissue anchor.

In one embodiment, the method further comprises locking the suture lock to the suture to maintain tension in a portion of the suture extending between the first tissue anchor and the second tissue anchor.

In one embodiment, the method further comprises disengaging the catheter from the suture lock after the suture lock is locked to the suture.

One aspect of the present disclosure relates to a tissue anchor having an anchor portion including a helical thread configured to be implanted in body tissue by rotation in a first direction about a longitudinal axis of the tissue anchor. The one or more barbs are configured to permit rotation of the tissue anchor in a first direction and to inhibit rotation of the tissue anchor in a second direction opposite the first direction. The tissue anchor further includes a driving portion rotatably fixed relative to the anchor portion. The drive portion is configured to removably engage with the drive member of the catheter such that rotation of the drive member rotates the drive portion and the anchor portion of the tissue anchor. The tissue anchor further includes a suture mounting portion configured to be connected to a suture at a suture mounting location.

In one embodiment, the suture mounting portion is rotatable relative to the anchor portion and the drive portion.

In one embodiment, the suture mounting portion is configured to rotate to align the suture mounting location with a direction of a force of the suture.

In one embodiment, the suture mounting portion is located between the drive portion and the anchor portion along the longitudinal axis.

In one embodiment, the one or more barbs include a plurality of barbs spaced apart from one another along the length of the helical thread.

In one embodiment, each of the one or more barbs includes an angled end having a tip positioned radially outward on the barb.

In one embodiment, the angled end has an angle between 30 degrees and 60 degrees.

In one embodiment, each of the one or more barbs is or includes a tubular element secured to a helical thread.

In one embodiment, the tubular element is straight.

In one embodiment, the tubular element defines an internal passageway having a diameter that is greater than the diameter of the helical thread to allow the tubular element to be advanced along the helical thread during manufacture.

Drawings

Reference numerals may be reused throughout all the figures to indicate general correspondence between reference elements. The drawings are provided to illustrate example embodiments described herein and are not intended to limit the scope of the disclosure.

FIG. 1 is a perspective view of a mitral valve remodeling system implanted in a mitral valve of a patient.

Fig. 2 is a perspective view of a tissue anchor of the system of fig. 1.

Fig. 2A is a side elevational view of the tissue anchor of fig. 2.

Fig. 2B is a top plan view of the suture mounting portion of the tissue anchor of fig. 2.

Fig. 3 is a perspective view of a suture lock of the system of fig. 1.

Fig. 4 is a cross-sectional view of the suture lock of fig. 3.

Fig. 5 is a view of a guide catheter and a delivery catheter for implantation of the system of fig. 1.

Fig. 6 is a perspective view of the delivery catheter of fig. 5.

Fig. 7 is a perspective view of a first tissue anchor implanted at a first location in a mitral valve of a patient.

Fig. 8 is a perspective view of a second tissue anchor implanted at a second location in a mitral valve of a patient.

Fig. 8A is a partial cross-sectional view of the tip of a delivery catheter for delivering a tissue anchor.

Fig. 9 is a perspective view of a suture lock placed in a second position in a patient's mitral valve.

Fig. 9A is a cross-sectional view of the tip of a delivery catheter for delivering a suture lock.

Fig. 10 is a perspective view of the excess portion of the suture being trimmed.

Fig. 11 is a process flow of a method for implanting and optionally adjusting a mitral valve remodeling system.

Fig. 12A is a perspective view of a portion of an alternative delivery catheter having a distal tip cap in which a tissue anchor is stored.

Fig. 12B shows the tissue anchor deployed from the distal tip cap with the suture extending through the slot in the distal tip.

Fig. 12C shows a suture passing through a slit in the distal tip cap.

Fig. 13 shows an alternative tissue anchor having multiple barbs on the anchor portion.

Fig. 14 shows a tissue anchor and a suture lock configured to be secured to the tissue anchor separately from a suture.

Fig. 15 illustrates a remodeling system having a blocking element configured to retain a portion of a suture and suture lock relative to an associated tissue anchor.

Detailed Description

Embodiments of the system, components, and method of assembly and manufacture will now be described with reference to the drawings, in which like numerals refer to the same or similar elements throughout. While several embodiments, examples and illustrations are disclosed below, those of ordinary skill in the art will understand that the invention described herein extends beyond the specifically disclosed embodiments, examples and illustrations and may include other uses and obvious modifications and equivalents of the invention. The terminology used in the description presented herein is not intended to be interpreted in any limited or restrictive manner simply because it is being used in conjunction with a detailed description of certain specific embodiments of the invention. In addition, embodiments of the invention may include several novel features and no single feature is solely responsible for its desirable attributes or necessary to practicing the invention described herein.

Certain terminology may be used in the following description for reference purposes only and is therefore not intended to be limiting. For example, terms such as "above" and "below" refer to directions in the drawings to which reference is made. Terms such as "front", "rear", "left", "right", "rear" and "side" describe the orientation and/or location of portions of a component or element within a consistent but arbitrary frame of reference which is made clear by reference to the text and associated drawings describing the component or element in question. Furthermore, terms such as "first," "second," "third," and the like, may be used to describe separate components. Such terminology may include the words specifically mentioned above, derivatives thereof and words of similar import.

The percutaneous techniques described in this disclosure aim to treat valve regurgitation by structurally altering the heart to increase leaflet coaptation. The technique is applicable to any atrioventricular valve (mitral and tricuspid valves) of the heart. The concept of repair is a ring-shaped approach to valve repair.

One or more embodiments of the techniques described in this disclosure have several advantages over currently commercially available or currently developed experimental techniques. These advantages include one or more of the following:

1. In one or more embodiments, the disclosed techniques allow for personalized reduction of regurgitation depending on the underlying pathology and valve size (in particular, where the anchors are placed and how much chords are tethered). From a practical point of view, the disclosed technology eliminates the need for hospitals to access a wide range of differently sized devices. The essentially only equipment required is the delivery catheter, anchors and chords.

2. The disclosed techniques may be conceptually particularly useful for a population of patients that have not been studied to date, such as patients with secondary mitral regurgitation due to atrial lesions or patients with tricuspid regurgitation due to pacemaker or defibrillator leads. However, one or more embodiments of the disclosed technology may also prove effective in secondary mitral regurgitation due to ventricular disease, or even in selected cases of primary mitral regurgitation.

3. In one or more embodiments, the disclosed techniques can be used as an adjunct to the prior art (edge-to-edge repair) in the presence or in anticipation of suboptimal results.

4. A further advantage of one or more embodiments of the disclosed technology is its ability to allow other future catheter-based valve repair or replacement strategies due to the ability to sever the repair chords.

5. As with most percutaneous repair strategies, one or more embodiments of the disclosed technology are expected to have shorter recovery times and better safety than open surgical repair or replacement.

6. The simplicity of comparing the disclosed technology with other currently available or tested prosthetic devices is surprising. The program time and learning curve may be advantageous due to their simple design.

7. Finally, the smaller access of the delivery system of one or more embodiments of the disclosed technology may eliminate concern for residual iatrogenic atrial septal defects following percutaneous transseptal access for mitral valve repair and allow for easy access via the right internal jugular vein for repair of the tricuspid valve.

These figures illustrate systems and methods for stabilizing or remodeling tissue. Preferably, the disclosed systems and methods are configured for remodeling soft tissue, such as cardiac tissue. The systems and related methods shown are configured for reshaping a mitral valve. However, the system, components thereof, and/or associated methods may be used for other purposes or may be modified for other applications. For example, the disclosed systems, components, or methods may be modified for stabilizing or reshaping other soft (e.g., muscle or connective tissue) or hard (e.g., bone) body tissue.

The illustrated system is configured for percutaneous transvascular delivery using one or more catheters or other suitable catheters. However, in alternative arrangements or applications, the system or components thereof as disclosed or modified by those skilled in the art may be delivered to or installed at the desired body location in other ways (e.g., through the use of direct methods).

Overview of the system

The illustrated system 100 for reshaping a mitral valve includes a first tissue anchor 102, a second tissue anchor 104, a suture 106, and a suture lock 110. Suture 106 extends between first tissue anchor 102 and second tissue anchor 104. The suture 106 may be fixed relative to the first and second tissue anchors 102, 104 to fix the distance between the tissue anchors 102, 104. The distance between the anchors 102, 104 may be adjusted to achieve a desired level of performance of the mitral valve. Suture lock 110 secures suture 106 relative to second tissue anchor 104 to maintain a desired distance between anchors 102, 104.

The first tissue anchor 102 is implanted in cardiac tissue of the patient at a first location 112, which may be at or near a mitral valve 114. The second tissue anchor 104 is implanted at a second location 116, which may be at or near the mitral valve 114. Preferably, the first tissue anchor 102 and the second tissue anchor 104 are each implanted at or near the annulus 120 of the mitral valve 114. Preferably, each of the tissue anchors 102, 104 is positioned sufficiently close to the annulus 120 such that the tissue has sufficient strength to support the tissue anchors 102, 104 without tearing or otherwise being damaged under normal or expected conditions.

In the arrangement shown, the first and second tissue anchors 102, 104 or the first and second locations 112, 116 are located on opposite sides of the mitral valve 114. Specifically, the first tissue anchor 102 is located on the posterior leaflet 122 and the second tissue anchor 104 is located on the anterior leaflet 124. However, these positions may also be reversed. The first tissue anchor 102 may be located within or at or near the central region of the posterior leaflet 122 in a direction along the sealing edge 126 of the mitral valve 114. The second tissue anchor 104 may be located in or near a central region or midpoint of the anterior/posterior leaflet 124 in a direction along the sealing edge 126 of the mitral valve 114.

Suture 106 has a first end 130 secured to first tissue anchor 102. As used herein, unless otherwise indicated, the term suture may refer to any suitable wire capable of connecting the tissue anchors 102, 104 and maintaining the tissue anchors 102, 104 at an adjusted separation distance (e.g., not stretched) under the expected conditions and over the expected lifetime of the system 100. Suture 106 extends from first tissue anchor 102 to second tissue anchor 104. The suture 106 engages the second tissue anchor 104 such that relative movement between the suture 106 and the second tissue anchor 104 is permitted. In the illustrated configuration, the suture 106 slides within or relative to the second tissue anchor 104. The length of the suture 106 between the tissue anchors 102, 104 can be adjusted to achieve a desired distance between the tissue anchors 102, 104. The distance between the tissue anchors 102, 104 may be adjusted to achieve a desired level of remodeling of the mitral valve 114 or a desired performance of the mitral valve 114.

Suture lock 110 may be secured at a desired location along the length of the portion of suture 106 not located between tissue anchors 102, 104. The suture lock 110 may contact the second tissue anchor 104 to limit the length of the suture 106 located between the tissue anchors 102, 104. When the suture 106 is used to remodel the mitral valve 114 by moving the first position 112 closer to the second position 116, the elasticity of the tissue of the mitral valve 114 will exert a force in a direction tending to move the anchors 102, 104 apart, thereby tensioning the portion of the suture 106 between the first tissue anchor 102 and the second tissue anchor 104. Thus, this portion of suture 106 may be referred to herein as a tension length 132. Thus, in some configurations, suture lock 110 is held against second tissue anchor 104 by tension of tension length 132 of suture 106. The suture lock 110 secures only the maximum separation distance of the first and second tissue anchors 102, 104, but permits the tissue anchors 102, 104 to move closer to each other.

In some configurations, suture lock 110 is reversible, as described further below. That is, suture lock 110 may be secured at a location along the length of suture 106 to define a desired tension length 132. The performance of the mitral valve 114 can then be observed, and if desired, the suture lock 110 can be released from the suture 106, moved to another location, and again secured to the suture 106 to define a different tension length 132. This process may be repeated until a desired level or performance of remodeling of mitral valve 114 is obtained.

Tissue anchor

In some configurations, the tissue anchors 102, 104 are identical or substantially identical to each other. Thus, a first tissue anchor 102 is described. The second tissue anchors 104 may be identical or substantially identical, or may be another suitable arrangement.

The illustrated tissue anchor 102 includes an anchor portion 140, a drive portion 142, and a suture mounting portion 144 disposed along a longitudinal axis 148 of the tissue anchor 102. In some configurations, suture mounting portion 144 is positioned adjacent to anchor portion 140. In the illustrated configuration, suture mounting portion 144 is located between anchor portion 140 and drive portion 142 along longitudinal axis 148.

The anchor portion 140 is configured to be implanted into tissue. Preferably, the anchor portion 140 is configured to be implanted into soft tissue (such as heart tissue). In some configurations, the anchor portion 140 is a threaded member that is implanted by rotation about the longitudinal axis 148. The anchor portion 140 is shown to include a helical member 150. The helical member 150 comprises an elongated member having a circular cross-section that is wrapped around the longitudinal axis 148 to define an elongated hollow space 152 extending along the longitudinal axis 148. The anchor portion 140 defines a length 151 sufficient to secure the anchor portion 140 in a desired tissue.

The driving portion 142 is configured to be engaged by a catheter or other implantation tool to allow implantation of the tissue anchor 102. The driving part 142 is fixed to rotate together with the anchor part 140 such that rotation of the driving part 142 causes rotation of the anchor part 140.

The drive portion 142 includes a drive surface 154 configured to engage a drive member of the catheter. In the arrangement shown, the shape of the drive surface 154 is non-circular. In the arrangement shown, the drive surface 154 is defined by an outwardly facing surface of the drive portion 142. The drive surface 154 is configured to engage an inwardly facing surface of a drive member of the catheter. The illustrated drive surface 154 has a square shape in a plane perpendicular to the longitudinal axis 148. However, other shapes may be used. Further, although the drive surface 154 is shown as an outwardly facing surface, the drive surface 154 may be defined by an inwardly facing surface of a tool cavity, for example.

The drive portion 142 defines a length 156 sufficient to permit the drive portion 142 to be engaged by a tool, such as a drive member of a catheter. In some configurations, the length of the drive surface 154 is equal to the length 156 of the drive portion 142.

Suture mounting portion 144 is movable relative to one or both of anchor portion 140 and drive portion 142. In some configurations, suture mounting portion 144 is movable relative to both anchor portion 140 and driving portion 142. In the arrangement shown, suture mounting portion 144 is rotatable relative to one or both of anchor portion 140 and drive portion 142. Preferably, the suture mounting portion 144 is rotatable about a longitudinal axis 148 of the tissue anchor 102.

In some configurations, suture mounting portion 144 includes a cylindrical body portion 158 having a relatively small length 160 or dimension extending along longitudinal axis 148. In some configurations, length 160 is less than diameter 162 or a largest dimension in a direction perpendicular to longitudinal axis 148. The body portion 158 includes a cylindrical sidewall 164 defining a peripheral surface of the body portion. The cylindrical sidewall 164 surrounds the longitudinal axis 148 and preferably extends in a direction parallel to the longitudinal axis. The cylindrical sidewall 164 defines a center point or axis 168. Preferably, the center point or axis 168 is offset from the longitudinal axis 148 of the tissue anchor 102.

Suture mounting portion 144 includes a suture mounting location 170 configured to connect to, engage with, or otherwise support a suture, wire, or other tension member. The suture mounting location 170 allows the suture 106 to extend from the tissue anchor 102 in a generally perpendicular direction relative to the longitudinal axis 148. As used herein, a suture 106 extending in a generally perpendicular direction means that the suture 106 is oriented closer to the perpendicular direction than the parallel direction.

In some configurations, suture mounting location 170 is configured to allow suture mounting portion 144 and tissue anchor 102 to slide over suture 106. In the arrangement shown, suture mounting location 170 includes a channel 172 that extends through body portion 158 of suture mounting portion 144 from a first surface 174 to a second surface 176. The first surface 174 is closer to the driving portion 142 and the second surface 176 is closer to the anchor portion 140. In some configurations, the channel 172 extends in a direction generally parallel to the longitudinal axis 148. The channel 172 of the first tissue anchor 102 allows the suture 106 to be tied or otherwise secured to the first tissue anchor 102. The channel 172 of the second tissue anchor 104 allows the second tissue anchor 104 to slide along the suture 106 such that the tension length 132 can be adjusted. As used herein, unless otherwise indicated, the term connecting may encompass both cases when used to describe the interaction between suture 106 and suture mounting portion 144.

Preferably, the channel 172 is located on a side of the center point or axis 168 opposite the longitudinal axis 148. Thus, a portion of the body portion 158 including the channel 172 is oriented in the direction of force on the suture 106. The body portion 158 protrudes from the longitudinal axis 148 a greater distance on the side of the channel 172 than on the opposite side of the channel 172. In the arrangement shown, suture 106 extends from the end of channel 172 closest to anchor portion 140. This arrangement advantageously positions the suture 106 close to the tissue surface to inhibit or reduce tilting of the tissue anchor 102 when the suture 106 is tensioned.

In some configurations, the length 151 of the anchor portion 140 is greater than one or both of the length 156 of the drive portion 142 and the length 160 of the suture mounting portion 144. In the arrangement shown, the length 151 of the anchor portion 140 is greater than both the length 156 of the drive portion 142 and the length 160 of the suture mounting portion 144. In some configurations, the length 156 of the drive portion 142 is greater than the length 160 of the suture mounting portion 144.

Suture lock

Suture lock 110 includes a first portion or base 180. A second portion or cap 182 of suture lock 110 is movable relative to base 180 along a longitudinal axis 184 of suture lock 110. The base 180 and cap 182 are rotationally fixed relative to one another. The threaded fastener 186 passes through an opening 190 in the cap 182 and engages a threaded cavity 192 of the base 180. Rotation of the threaded fastener 186 in a first direction moves the cap 182 toward the base 180, and rotation of the threaded fastener 186 in a second, opposite direction moves the cap 182 away from the base 180. Thus, the suture lock 110 can clamp the locking portion 188 of the suture 106 between the base 180 and the cap 182, release the suture 106 to allow adjustment of the position of the suture lock 110 relative to the suture 106, and then re-clamp the suture 106.

The base 180 and cap 182 include cooperating structures that inhibit or prevent relative rotation. The cooperating structures may be one or more flat surfaces or non-circular surfaces relative to the longitudinal axis 184.

In the arrangement shown, the base 180 is generally cylindrical in shape. The base 180 includes a protruding portion in the form of a central hub 200 defining at least one non-circular surface (e.g., a planar surface 202). In the arrangement shown, the hub 200 defines a pair of planar surfaces 202 spaced apart from one another on opposite sides of the longitudinal axis 184. The illustrated base 180 is symmetrical about a longitudinal axis 184. Thus, the planar surface 202 as shown is equidistant from the longitudinal axis 184. As used herein with respect to a structure that inhibits or prevents rotation, a non-circular surface is a surface in which the surface may cooperate with another surface to inhibit or prevent rotation about longitudinal direction 184. For example, such surfaces may include flat or curved surfaces having a curvature about a center that is not located on the longitudinal axis 184.

The planar surfaces 202 each have at least one component extending in a direction parallel to the longitudinal axis 184. In the arrangement shown, the planar surfaces 202 are each oriented parallel to the longitudinal axis 184. Thus, the planar surface 202 permits axial movement of the cap 182 relative to the base 180 but inhibits or prevents rotational movement of the cap 182 relative to the base 180.

Each of the planar surfaces 202 is formed by a cut-out portion of a cylindrical workpiece that extends only partially through the workpiece in the longitudinal direction such that the base 180 further includes at least one flange portion or base flange 204. In the arrangement shown, the base 180 includes a pair of flange portions, which are referred to hereinafter as flanges 204 for convenience. Each flange 204 defines a shoulder surface or shoulder 206 adjacent the planar surface 202. The shoulder 206 provides a stop surface to limit axial movement of the cap 182 along the longitudinal axis 184. Shoulder 206 also provides a surface upon which suture 106 may be clamped, as described further below.

The cap 182 is generally cylindrical in shape, with the central cutout defining a space 210 that receives a portion of the base 180. Specifically, the space 210 receives the hub 200 of the base 180. The illustrated cap 182 defines an end wall portion 212 and a pair (e.g., first and second) of depending sidewall portions 214 that cooperate to define the space 210. The end wall portion 212 defines an opening 190 through which the threaded fastener 186 passes. The first and second sidewall portions 214 each define a surface 216 that cooperates with one of the planar surfaces 202 to inhibit or prevent relative rotation between the base 180 and the cap 182. The surface 216 may be non-circular. In the arrangement shown, the surface 216 of the sidewall portion 214 is flat. Thus, in the arrangement shown, both the surface 202 and the surface 216 of the base 180 are planar. However, other arrangements are possible in which only one of the surfaces 202, 216 is planar, or in which neither surface 202, 216 is planar, but are otherwise configured to cooperate with each other to inhibit or prevent rotation between the base 180 and the cap 182. The illustrated planar surface 216 of the cap 182 is in sliding contact with the planar surface 202 of the base 180 to permit axial movement and inhibit or prevent rotational movement of the cap 182 relative to the base 180.

The end of the sidewall portion 214 opposite the end wall portion 212 terminates in an outwardly or radially extending flange 220. The portion of the sidewall portion 214 adjacent the flange 220 defines a planar surface 222. The planar surfaces 222 are parallel to each other in the arrangement shown, but may be non-parallel in other configurations. A planar surface 222 is positioned radially inward from the outermost extent of flange 220 to define a stop surface or shoulder 224. The flat surface 222 may be utilized such that a tool (e.g., a catheter) may hold the cap 182 against rotation while rotating the threaded fastener 186 to move the base 180 and the cap 182 toward or away from each other along the longitudinal axis 184.

As described above, the suture 106 may be captured or clamped between the base 180 and the cap 182. Suture 106 may be captured or clamped between flange 204 of base 180 and corresponding flange 220 of cap 182. In some configurations, one or both of the base 180 and the cap 182 include suture retaining features configured to retain the suture 106 to the base 180 and/or the cap 182 or at least inhibit or prevent the suture 106 from completely separating from the base 180 and/or the cap 182. In the arrangement shown, at least one of the flanges 204 of the base 180 includes a suture channel 226 configured to receive the suture 106. However, in other arrangements, at least one of the flanges 220 of the cap 182 or both the flange 204 of the base 180 and the flange 220 of the cap 182 may include suture passages 226.

In the arrangement shown, suture channel 226 extends from end surface 230 through flange 204 to shoulder surface 206. In some configurations, the channel 226 extends in a direction generally parallel to the longitudinal axis 184. As used herein, substantially parallel means that the channels 226 are oriented closer to parallel than perpendicular. The channel 226 allows the suture 106 to remain to the base 180 of the suture lock 110. The channel 226 allows the tissue anchor 110 to slide along the suture 106. The channel 226 retains a portion of the suture 106 between the flange 204 of the base 180 and the flange 220 of the cap 182 such that the suture 106 may be selectively clamped by movement of the cap 182 toward the base 180.

The threaded fastener 186 may be or may be similar to a socket head cap screw. The threaded fastener 186 has a threaded shaft portion or shaft 232 and a head portion or head 234. The head 234 has a diameter or cross-sectional size that is larger than the shaft 232. The head 234 may define one or more surfaces configured to engage a tool. In the arrangement shown, the head 234 defines a tool cavity 236, such as a hexagonal tool cavity. The shaft 232 passes through the opening 190 of the cap 182 and engages the threaded cavity 192 of the base 180. The head 234 contacts the end wall portion 212 of the cap 182 to retain the cap 182 on the base 180. As previously described, contact between the head 234 and the end wall portion 212 allows the threaded fastener 186 to selectively move the cap 182 toward the base 180 to clamp the suture 106 or allow the cap 182 to move away from the base 180 to release the suture 106.

Delivery catheter

As previously described, the system 100 utilizes one or more catheters to deliver and implant or install components of the system 100 within a desired anatomy of a patient, such as the mitral valve 114 of the heart in the illustrated application. The catheter may be a steerable catheter, as is known in the art. In some embodiments, the system 100 includes an anchor delivery catheter 250 configured to deliver one or both of the tissue anchors 102, 104 from outside the patient's body into the patient's heart. The delivery catheter 250 is configured to implant the tissue anchors 102, 104 into a desired tissue of a patient, such as the mitral valve 114.

The delivery catheter 250 includes an elongate catheter body or tube 252. A handle 254 may be connected to the outer end of the tube 252 and may be configured to allow a user to control the delivery catheter 250. The delivery end of the tube 252 inserted into the patient includes a tip 256 configured to engage the tissue anchors 102, 104. The illustrated tip 256 has a first portion 260 and a second portion 262. The first portion 260 is a fixed portion that is secured to the tube 252 in a rotationally fixed manner. The second portion 262 is a rotatable portion that is rotatable relative to the first portion 260 and thus relative to the tube 252.

Delivery catheter 250 includes a drive element configured to selectively rotate second portion 262 of tip 256. In the arrangement shown, the drive element is an elongate drive shaft 264 that extends from the handle 254 through the tube 252 to the second portion 262 of the tip 256. The drive shaft 264 is coupled to the second portion 262 of the tip 256 such that torque may be transferred from the drive shaft 264 to the second portion 262 of the tip 256. Thus, rotation of the drive shaft 264 causes rotation of the second portion 262 of the tip 256. Rotation of the drive shaft 264 may be actuated by the handle 254, such as via a dial or knob 266 or other suitable control member. The handle 254 in fig. 7 is not shown to scale.

The diameter or cross-sectional dimension of the first portion 260 of the tip 256 may be greater than the diameter or cross-sectional dimension of the second portion 262 of the tip 256 and/or the tube 252. Preferably, the diameter or cross-sectional dimension of the first portion 260 of the tip 256 is greater than the diameter or cross-sectional dimension of the second portion 262 of the tip 256 and the tube 252. First portion 260 of tip 256 may include a suture channel 270 configured to receive suture 106. Suture channel 270 may extend generally in the axial direction of delivery catheter 250. Preferably, the delivery catheter 250 is a "quick-exchange" catheter in which the suture 106 passes through only a small portion of the catheter 250 and is otherwise external to the catheter 250. In the illustrated configuration, suture 106 passes only through suture channel 270 of tip 256 and is entirely external to tube 252.

The second portion 262 of the tip 256 defines an engagement portion configured to engage the tissue anchors 102, 104 and transfer torque from the second portion 262 of the tip 256 to the tissue anchors 102, 104. In the illustrated arrangement, the second portion 262 of the tip 256 defines a tool cavity 272 configured to receive the driving portion 142 of the tissue anchors 102, 104. The tool cavity 272 and the drive portion 142 each have non-circular cross-sectional shapes that are complementary to one another. In the arrangement shown, each of the tool cavity 272 and the drive portion 142 has a square cross-sectional shape. Thus, the driving portion 142 of the tissue anchors 102, 104 can be slid into the tool cavity 272 of the second portion 262 of the tip 256. Accordingly, the tissue anchors 102, 104 can be selectively engaged and disengaged from the tip 256 of the delivery catheter 250. In addition, rotation of the second portion 262 of the tip 256 causes rotation of the drive portion 142 of the tissue anchors 102, 104.

The illustrated system 100 also includes a suture lock delivery conduit 280 configured to deliver and mount the suture lock 110. The delivery catheter 280 may be similar to the delivery catheter 250 that delivers the tissue anchors 102, 104. The delivery catheter 280 is shown to include an elongate catheter body or tube 282. A handle 284 may be connected to the outer end of the tube 282 and may be configured to allow a user to control the delivery catheter 280. The delivery end of the tube 282 inserted into the patient includes a tip 286 configured to engage the suture lock 110. The tip 286 is secured to the tube 282 in a rotationally fixed manner.

The diameter or cross-sectional dimension of the tip 286 may be greater than the diameter or cross-sectional dimension of the tube 282. Tip 286 can include a suture channel 290 configured to receive suture 106. Suture channel 290 may extend generally in the axial direction of delivery catheter 280. Preferably, the delivery catheter 280 is a "quick-exchange" catheter in which the suture 106 passes through only a small portion of the catheter 280 and is otherwise external to the catheter 280. In the illustrated configuration, the suture 106 passes through only the suture channel 290 of the tip 286 and is entirely external to the tube 282.

Tip 286 defines an engagement portion configured to engage suture lock 110. In particular, tip 286 is configured to retain cap 182 of suture lock 110 and inhibit or prevent rotation of cap 182, such that threaded fastener 186 may be rotated relative to cap 182 to move base 180 toward or away from cap 182. In the arrangement shown, tip 286 defines a cavity 292 configured to receive cap 182 of suture lock 110. The cavity 292 includes an engagement surface 294 that engages the planar surface 222 of the cap 182 of the tissue anchor 110. Accordingly, cap 182 of suture lock 110 may be slid into cavity 292 of tip 286. Accordingly, cap 182 of suture lock 110 may be selectively engaged and disengaged with tip 286 of delivery catheter 280. Additionally, tip 286 may hold cap 182 of suture lock 110 against rotation.

Delivery catheter 250 includes a drive element configured to selectively rotate threaded fastener 186 of suture lock 110. In the arrangement shown, the drive element is an elongated drive shaft 296 that extends from the handle 284 through the tube 282 to the tip 286. The drive shaft 296 carries a drive element (such as a drive tip or drive tool 298) configured to transfer torque from the drive shaft 296 to the threaded fastener 186. In the arrangement shown, the driving tool 298 has a shape complementary to the tool cavity 236 of the threaded fastener 186. Thus, rotation of the drive shaft 296 causes rotation of the threaded fastener 186. Rotation of the drive shaft 296 may be actuated by the handle 284, such as via a dial or knob 300 or other suitable control member. The handle 284 in fig. 9 is not shown to scale.

Suture trimmer

The system 100 can also include a suture trimmer 350 configured to sever or trim excess portions of the suture 106. In the arrangement shown, suture trimmer 350 includes an elongated catheter body or tube 352. A handle 354 may be connected to the outer end of the tube 352 and may be configured to allow a user to control the suture trimmer 350. The trimmed end of tube 352 inserted into the patient includes a distal end 356 configured to trim suture 106.

The illustrated tip 356 has a first portion 360 and a second portion 362. The second portion 362 is axially movable relative to the first portion 360. The first portion 360 supports or houses a cutting blade 364. The second portion 362 is configured to receive and retain the suture 106 for cutting by the cutting blade 354. Second portion 362 defines a suture channel 366 configured to receive suture 106. Suture channel 366 extends in a radial or substantially radial direction of tube 352. That is, suture channel 366 may extend in a radial direction or in a direction that is oblique to the longitudinal axis of tube 352.

The illustrated second portion 362 of the tip 356 also includes a slot 370 configured to receive the cutting blade 364 as the second portion 362 moves axially toward the first portion 360. Slot 370 intersects suture channel 366. Thus, when suture 106 is positioned within suture channel 366, cutting blade 364 can be moved into slot 370 to cut suture 106 by movement of second portion 362 of tip 356 toward first portion 360. In the arrangement shown, the slot 370 extends through the end of the second portion 362 of the tip 356. However, in other arrangements, the slot 370 may have a closed end. In other arrangements, the second portion 362 of the tip may be fixed and the blade 364 may be configured to move.

Suture trimmer 350 includes an actuator for moving second portion 362 toward first portion 360 to advance cutting blade 364 into slot 370. In the illustrated arrangement, suture trimmer 350 includes an actuation wire or shaft 372. An actuation wire 372 extends from the handle 354 to the second portion 362 of the tip 356. A user control element, such as a button, knob, dial, or lever 374, may be located on the handle 374 and coupled to the actuation wire 372. The control element 374 may exert a pulling force on the actuation wire 372 that tends to move the second portion 362 of the tip 356 in an axial direction toward the first portion 360. Thus, cutting blade 364 is advanced through slot 370 to cut suture 106. The handle 354 in fig. 10 is not shown to scale.

Advantageously, the arrangement shown allows the suture 106 to be trimmed at a location proximate to the suture lock 110. Thus, a relatively short length of excess suture 106 remains within the patient. For example, if slot 370 is centered in tube 352 or end 356 and suture channel 366 is oriented in a radial direction of tube 352 or end 356, the excess portion of suture 106 may be equal to or less than the radius of end 356, such as second portion 362 of end 356. Thus, the second portion 362 of the tip 356 may be configured to have a diameter or cross-sectional dimension that is less than one or both of the first portion 360 of the tip 356 and the tube 352.

Method

The components of the system 100 may be delivered to the patient's mitral valve 114 by any suitable method. In some configurations, components of the system 100 are directed to the left atrium via a transseptal approach, wherein an incision is made in the atrial portion of the septum to allow access from the right atrium, such as via the inferior or superior vena cava. The guide catheter 310 may be guided to the left atrium by any suitable method, such as any transvascular method known in the art. The guide catheter 310 may be configured to receive the delivery catheters 250, 280.

In one implantation method of the system 100, the suture 106 is attached to the first tissue anchor 102 by any suitable arrangement or method, as indicated by block 400. For example, the suture 106 may be passed through the passage 172 of the suture mounting location 170 of the first tissue anchor 102 and tied to itself using a suitable knot. Preferably, suture 106 extends from second surface 176 of anchor portion 140 such that suture 106 is positioned adjacent to tissue of mitral valve 114.

At block 402, the first tissue anchor 102 may be loaded onto the delivery catheter 250. For example, suture 106 may be passed through suture channel 270 of first portion 260 of end 256 of catheter 250. Suture 106 may be passed through channel 270 in a direction from tip 256 toward tube 252. The driving portion 142 of the first tissue anchor 102 can be inserted into the tool lumen 272 of the tip 256 of the catheter 250.

At block 404, the delivery catheter 250 may be used to deliver the first tissue anchor 102 to the first location 112. For example, the delivery catheter 250 may be passed through the guide catheter 310 to the first location 112 using a suitable guiding technique. During delivery, the suture 106 may be tensioned to help maintain the first tissue anchor 102 in engagement with the tip 256.

At block 406, the first tissue anchor 102 is implanted at the first location 112. For example, knob 266 may be used to rotate drive shaft 264, which rotates second portion 262 of tip 256 of catheter 250. Rotation of the second portion 262 in turn rotates the drive portion 142 and the anchor portion 140 of the first tissue anchor 102. Rotation of the anchor portion 140 screws the first tissue anchor 102 into the tissue of the mitral valve 114 at the first location 112. Tension may be maintained on the suture 106 to inhibit or prevent rotation of the mounting portion 144 of the first tissue anchor 102, which may prevent the suture 106 from wrapping around the delivery catheter 250.

At block 408, the delivery catheter 250 is withdrawn from the guide catheter 310, leaving the first tissue anchor 102 in place at the first location 112 of the mitral valve 114. Suture 106 may be removed from end 256 of delivery catheter 250.

At block 410, the second tissue anchor 104 may be loaded onto the delivery catheter 250. For example, the suture 106 may be passed through the suture channel 172 of the second tissue anchor 104. Suture 106 may be passed through suture channel 172 in a direction from second surface 176 to first surface 174 such that suture 106 is positioned adjacent tissue of mitral valve 114. Suture 106 may be passed through suture channel 270 of first portion 260 of end 256 of catheter 250. Suture 106 may be passed through channel 270 in a direction from tip 256 toward tube 252. The driving portion 142 of the second tissue anchor 104 can be inserted into the tool lumen 272 of the tip 256 of the catheter 250.

At block 412, the delivery catheter 250 may be used to deliver the second tissue anchor 104 to the second location 116. For example, the delivery catheter 250 may be passed through the guide catheter 310 to the second location 116 using a suitable guiding technique. During delivery, the suture 106 may be tensioned to help maintain the second tissue anchor 102 in engagement with the tip 256.

At block 414, the second tissue anchor 104 is implanted at the second location 116. For example, knob 266 may be used to rotate drive shaft 264, which rotates second portion 262 of tip 256 of catheter 250. Rotation of the second portion 262 in turn rotates the drive portion 142 and the anchor portion 140 of the second tissue anchor 104. Rotation of the anchor portion 140 screws the second tissue anchor 104 into the tissue of the mitral valve 114 at the second location 116. Tension may be maintained on the suture 106 to inhibit or prevent rotation of the mounting portion 144 of the second tissue anchor 104, which may prevent the suture 106 from wrapping around the delivery catheter 250.

At block 416, the delivery catheter 250 is withdrawn from the guide catheter 310, leaving the second tissue anchor 104 in place at the second location 116 of the mitral valve 114. Suture 106 may be removed from end 256 of delivery catheter 250.

At block 418, suture lock 110 may be loaded onto delivery catheter 280. For example, the suture 106 may be passed through a suture channel 226 of the base 180 of the suture lock 110. Suture 106 may be passed through suture channel 226 in a direction from end surface 230 to shoulder surface 206. Suture 106 may be passed through suture channel 290 of distal end 286 of delivery catheter 280. A driving tool 298 may be inserted into the tool cavity 236 of the threaded fastener 186. Cap 182 may be inserted into lumen 292 of tip 286 of delivery catheter 280.

At block 420, suture lock 110 may be delivered to second location 116 using delivery catheter 280. For example, the delivery catheter 280 may be passed through the guide catheter 310 to the second location 116 using a suitable guiding technique. During delivery, suture 106 may be tensioned to help maintain suture lock 110 in engagement with tip 286.

At block 422, the tension length 132 of the suture 106 may be adjusted. For example, the end surface 230 of the suture lock 110 may be positioned against the first surface 174 of the suture mounting portion 144 of the second tissue anchor 104. The suture 106 may be pulled and the column strength of the delivery catheter 280 may hold the second tissue anchor 104 and suture lock 110 in place. Accordingly, the suture 106 may be pulled through the respective suture passages 172, 226, 290 of the second tissue anchor 104, the suture lock 110, and the distal end 286 of the catheter 280. Thus, the first tissue anchor 102 is pulled toward the second tissue anchor 104 and the tension length 132 decreases. Suture 106 may also be released and the inherent elasticity of the tissue of mitral valve 114 may increase tension length 132.

Once the desired tension length 132 has been reached, the suture lock 100 may be locked to secure the suture 106 relative to the suture lock 110 at block 424. For example, knob 300 may be used to rotate drive shaft 296. Rotation of drive shaft 296 rotates drive tool 298, which rotates threaded fastener 186 of suture lock 110. Rotation of the threaded fastener 186 causes the base 180 and cap 182 of the suture lock 110 to move toward each other, thereby clamping the suture 106 between the shoulder surface 206 of the base 180 and the flange 220 of the cap 182.

Once suture lock 110 has been locked, but before delivery catheter 280 has been removed from suture lock 100, performance or operation of mitral valve 114 may be monitored by any suitable imaging procedure at block 430.

At block 426, delivery catheter 280 may be withdrawn, leaving suture lock 110 in place. For example, catheter tip 286 and driving tool 298 may be removed from cap 182 and threaded fastener 186, respectively, and delivery catheter 280 may be withdrawn from guide catheter 310.

At block 428, excess portions of suture 106 may be trimmed. For example, suture 106 may be passed through suture channel 366 of suture trimmer 350. The end of suture trimmer 350 including tip 356 can be inserted into guide catheter 310 and advanced to second location 116. Tip 356 slides along suture 106 such that the end of suture 106 remains outside the patient. Suture 106 may guide end 356 of suture trimmer 350 to suture lock 110. Once end 356 of suture trimmer 350 is positioned adjacent suture lock 110, control element 374 can be actuated to advance cutting blade 364 and cut suture 106 within slot 370. The outer end of the suture 106 may be held to maintain tension in the excess portion of the suture 106, allowing for easier cutting.

As described above, the system 100 is configured such that the tension length 132 may be set, the operation of the mitral valve 114 monitored, and the tension length 132 changed if desired. This process may be repeated until the desired result is achieved.

Optionally, returning to block 430, once suture lock 110 has been locked, but before delivery catheter 280 has been removed from suture lock 100, the performance or operation of mitral valve 114 may be monitored by any suitable imaging procedure.

Optionally, at block 432, if adjustment is desired, suture lock 110 may release suture 106 to allow adjustment of tension length 132. For example, knob 300 may be used to rotate drive shaft 296 and drive tool 298 in a counter-clockwise direction (or in a direction opposite to that used to clamp suture 106). Rotation of the drive tool 298 rotates the threaded fastener 186, which allows the cap 182 to move away from the base 180. Thus, the suture 106 is no longer clamped between the cap 182 and the base 180 and is permitted to move relative to the suture lock 110 and the second tissue anchor 104.

The tension length 132 may be adjusted as described above with respect to block 422. Once the desired tension length 132 is obtained, the suture 106 may be locked as described with respect to block 424. The method may then return to block 430 to permit further monitoring and, if desired, further adjustment. If the desired operation or performance of the mitral valve 114 has been achieved, the method may move to block 426 and block 428 to release the suture lock 110 and trim the suture 106, as described above.

Tissue anchor cap

Fig. 12A-12C illustrate an alternative delivery catheter 250 having a distal tip cap 500 at the distal end or delivery end of a catheter tube 252. The cover 500 may be configured to house (e.g., cover) the tissue anchors 102, 104 to inhibit or prevent the tissue anchors 102, 104 from damaging tissue (e.g., vasculature or heart tissue) prior to deployment. The cap 500 may be attached (such as glued or otherwise secured) to or around the end 256 of the catheter tube 252 at the connection 501. The cover 500 may be generally tubular in form and may define an interior space that receives the tissue anchors 102, 104. The cap 500 may have an open distal end through which the tissue anchors 102, 104 may be deployed.

The cover 500 includes a through hole in the form of a slot 502 that passes through a sidewall of the cover 500 in a radial direction. The slot 502 receives the suture 106 such that the suture 106 may pass from the exterior of the cover 500 to the interior of the cover 500. As described above, the suture 106 engages the tissue anchors 102, 104 initially located within the cover 500 prior to deployment. Thus, the suture 106 is positioned outside of the catheter tube 252 and through the slot 502 to engage the tissue anchors 102, 104, as shown in FIG. 12B.

The cap 500 also includes a slit 504 extending longitudinally from the slot 502 to a distal or free end of the cap 500. The slit 504 passes completely through the side wall of the cover 500. Thus, when the tissue anchors 102, 104 are deployed from the cover 500, the suture 106 can pass from the slot 502 through the slit 504, allowing the suture 106 to be separated or disengaged from the cover 500 and the catheter 250. Fig. 12C shows suture 106 passing through slit 504.

This arrangement advantageously provides protection for the tissue anchors 102, 104 and protects other tissue from the sharp ends of the tissue anchors 102, 104 until deployment. The cover 500 also allows the suture 106 to be simply disengaged from the cover 500. The cover 500 may be constructed of any suitable material or combination of materials. For example, the cap 500 may be constructed from one or more suitable medical grade polymeric materials. The cap 500 may be implemented with the system 100 or components of the system 100 described with respect to fig. 1-11 (such as the delivery catheter 250 of fig. 1-11). Alternatively, the catheter 250 of fig. 12A-12C may be used with the system 100 of fig. 1-11.

Tissue anchor with barbs

Fig. 13 illustrates an alternative tissue anchor 102 that provides improved intra-tissue retention relative to the tissue anchors 102, 104 described above. The tissue anchor 102 of fig. 13 is similar to the prior art tissue anchors 102, 104, and thus, like reference numerals are used to refer to like or corresponding parts or features. The alternative tissue anchor 102 is described in the context of differences relative to the previously described tissue anchors 102, 104. It may be assumed that any components or features of the alternative tissue anchor 102, not described in detail, are the same as or similar to components or features of the tissue anchors 102, 104, or may have another suitable arrangement. Further, the tissue anchor 102 of fig. 13 may replace either or both of the tissue anchors 102, 104 in the systems and methods described above.

The illustrated tissue anchor 102 includes an anchor portion 140, a drive portion 142, and a suture mounting portion 144 disposed along a longitudinal axis 148 of the tissue anchor 102. In the illustrated configuration, suture mounting portion 144 is located between anchor portion 140 and drive portion 142 along longitudinal axis 148.

As described above, the anchor portion 140 is configured to be implanted into soft tissue (such as heart tissue). The illustrated anchor portion 140 includes a helical member 150 implanted by rotation (e.g., clockwise rotation) about the longitudinal axis 148. The helical member 150 comprises an elongated member having a circular cross-section that is wrapped around the longitudinal axis 148 to define an elongated hollow space 152 extending along the longitudinal axis 148.

The anchor portion 140 of the tissue anchor 102 of fig. 13 includes at least one barb 600 or other like protrusion configured to resist rotation (e.g., counterclockwise rotation) of the anchor portion 140 in a direction tending to remove the tissue anchor 102 from tissue. Preferably, the anchor portion 140 includes a plurality of barbs 600 spaced apart from one another along the length of the helical member 150 and/or along the longitudinal axis 148. In the arrangement shown, the anchor portion 140 includes three barbs 600. However, other numbers of barbs 600 may be used, such as, but not limited to, one, two, four, five, six, or more barbs 600. The number of barbs 600 may be selected to provide a desired amount of resistance to remove the tissue anchor 102 for the intended use.

Each barb 600 is configured to permit implantation of the tissue anchor 102 with a first level of resistance and to inhibit removal of the tissue anchor 102 with a second level of resistance greater than the first level of resistance. For example, each barb 600 may be configured to permit rotation in the direction of implantation (e.g., clockwise rotation) to permit implantation of the tissue anchor 102 and resist rotation in the direction of removal (e.g., counterclockwise rotation). In some configurations, each barb 600 includes an end 602 configured to engage tissue to resist rotation of the anchor portion 140 of the tissue anchor 102 in the removal direction. In some configurations, the end 602 is an angled end that is oriented at an angle relative to a tangential direction of the location on the spiral member 150 where the barb 600 is disposed. The angled end 602 is oriented such that the tip 603 is positioned radially outward on the barb 600. With this arrangement, barb 600 allows rotation in the direction of implantation (e.g., clockwise rotation) and resists rotation in the opposite direction of removal (e.g., counterclockwise rotation).

In some configurations, each barb 600 is formed from or includes a tubular element or tube 604. The tube 604 may define an internal passage having a diameter and/or cross-sectional area that is equal to or slightly larger than the diameter and/or cross-sectional area of the helical member 150. The tube 604 may be formed separately from the screw member 150 and assembled thereto. Preferably, the tube 604 is configured to be movable along the screw member 150 such that the tube 604 can be assembled to the screw member 150. For example, the tube 604 can be pushed onto the end of the helical member 150 and advanced along the helical member toward the drive portion 142 and suture mounting portion 144 of the tissue anchor 102. Tube 604 may be secured at a desired location along helical member 150 by any suitable arrangement or method. For example, tube 604 may be an interference fit with helical member 150 and/or may be secured by, for example, but not limited to, brazing, welding, or an adhesive.

In some configurations, the tube 604 may be straight or linear. The angled end 602 may define an angle relative to a longitudinal axis 606 of the tube 604. In some configurations, the tube 604 may be curved along its length. In this configuration, the angle of the angled end 602 may be measured relative to an axis that passes through the geometric center of the cross-section of the tube 604 and is oriented perpendicular to the cross-sectional plane. In some configurations, the angle may be between 20 degrees to 70 degrees, 30 degrees to 60 degrees, 40 degrees to 50 degrees, or about 45 degrees.

Although barb 600 is shown as being formed from a member that is formed separately from spiral member 150, other suitable methods or structures for forming barb 600 may be used. For example, barb 600 may be integrally formed with spiral member 150. In some configurations, the spiral member 150 may be formed with barbs 600 in place, such as by a forming or three-dimensional printing process. In other configurations, the work piece used to form the spiral member 150 may be grooved or cut such that barbs 600 are formed when the work piece is wound to form the spiral shape of the spiral member 150. Alternatively, the barb 600 may be formed by grooving or cutting the spiral member 150 after it is provided in a spiral form. Furthermore, although the barbs 600 are shown as being integral with and rotating with the spiral member 150, in other configurations, the barbs 600 or other anti-rotation features may be individually deployed and/or engaged once the tissue anchor 102 has been implanted by a suitable actuation device (e.g., push rod).

As in the tissue anchors 102, 104 described above, the driving portion 142 of the tissue anchor 102 of fig. 13 is configured to engage a catheter or other implantation tool to permit implantation of the tissue anchor 102. The driving part 142 is fixed to rotate together with the anchor part 140 such that rotation of the driving part 142 causes rotation of the anchor part 140.

As in the tissue anchors 102, 104 described above, the suture mounting portion 144 of the tissue anchor 102 of fig. 13 can be rotated relative to one or both of the anchor portion 140 and the drive portion 142. Preferably, the suture mounting portion 144 is rotatable about a longitudinal axis 148 of the tissue anchor 102. Suture mounting portion 144 includes a suture mounting location 170 configured to connect to, engage with, or otherwise support a suture, wire, or other tension member. The suture mounting location 170 allows the suture 106 to extend from the tissue anchor 102 in a generally perpendicular direction relative to the longitudinal axis 148.

In the arrangement shown, suture mounting location 170 includes a channel 172 that extends through body portion 158 of suture mounting portion 144 from a first surface 174 that is closer to drive portion 142 to a second surface 176 that is closer to anchor portion 140. In some configurations, the channel 172 extends in a direction generally parallel to the longitudinal axis 148. The channel 172 of the tissue anchor 102 allows the suture 106 to be tied or otherwise securely fastened to the first tissue anchor 102 or allows the tissue anchor 102 to slide along the suture 106 such that the tension length 132 (fig. 1) can be adjusted, as described above. Thus, the tissue anchor 102 of fig. 13 may perform the functions of either of the previously described tissue anchors 102, 104.

The tissue anchor 102 of fig. 13 provides increased resistance to removal from tissue via one or both of direct pullout or withdrawal by rotation. Thus, in at least some instances, preferably, in any of the systems or methods described herein, one or both of the previously described tissue anchors 102, 104 are replaced with the tissue anchor of fig. 13 to provide increased resistance to removal from the tissue in which the tissue anchor 102 is implanted. Accordingly, any of the tissue anchors 102, 104 described herein can be replaced or otherwise modified by the tissue anchor 102 of fig. 13 to include barbs or other protrusions or features that increase retention.

Suture lock retention

In some cases, it may be desirable to retain the suture lock 110 relative to one of the tissue anchors 102, 104. For example, where suture 106 is severed, it may be desirable to prevent suture lock 110 from being unconstrained or free floating within the heart or other organ or anatomical location. In some cases, further intervention may be desirable in lieu of the remodeling system 100. Such interventions may include additional valve repair or valve replacement. Implementation of these further interventions may require cutting the suture to reduce or eliminate the effects of the remodeling system 100. In the remodeling system 100 shown in fig. 1, the suture lock 110 is not permanently coupled to the associated tissue anchor 104, but is held in place against the tissue anchor 104 by the tension of the suture 106. Once the suture 106 is severed, the suture lock 110 is no longer held in place relative to the tissue anchor 104 and is able to move within the patient's anatomy. To avoid this, certain embodiments of the remodeling system 100 may be configured to retain the suture lock 110 relative to another component of the system 100, which is preferably an implant component (e.g., one of the tissue anchors 102, 104) that is fixed within the anatomy of the patient. Suture lock 110 may be coupled directly or indirectly with respect to an associated component (e.g., tissue anchors 102, 104).

As shown in fig. 14, suture lock 110 may be configured to be secured to tissue anchors 102, 104. In particular, the suture lock 110 may be directly secured to the tissue anchors 102, 104. In the arrangement shown, the suture lock 110 is configured to be directly secured to the suture mounting portions 144 of the tissue anchors 102, 104. For example, the suture lock 110 may be a clamp (such as a chuck or collet) that surrounds the suture 106 and is configured to apply a clamping force to the suture 106 when the suture lock 110 is secured to the tissue anchors 102, 104. However, the clamping force and coupling to the tissue anchors 102, 104 may also be accomplished separately.

In the illustrated arrangement, suture lock 110 includes an externally threaded surface 700 configured to engage an internally threaded surface (not shown) of channel 172 of tissue anchors 102, 104. The external threaded surface 700, the internal threaded surface, or both may be tapered or include tapered portions, or another suitable arrangement may be provided such that the suture lock 110 grips the suture 106 as the suture lock 110 is advanced into the channel 172 to couple the suture 106 to the suture lock 110 and the suture lock 110 to the tissue anchors 102, 104. Advantageously, with this arrangement, if the suture 106 is severed, the suture lock 110 remains secured to the tissue anchors 102, 104. Because the tissue anchors 102, 104 are firmly implanted, the suture lock 110 also remains fixed in place within the patient's anatomy.

Fig. 15 illustrates another retaining arrangement for securing suture lock 110. In particular, the arrangement of fig. 15 is configured to use a portion of the suture 106 to retain the suture lock 110 adjacent to the associated tissue anchor 104. In the arrangement shown, a stop element, stop element or blocking element 750 (such as a metal band or ferrule) is secured to the suture 106 between the tissue anchors 102, 104 or on the opposite side of the suture mounting portion 144 of the associated tissue anchor 104 from the suture lock 110. The blocking element 750 is configured to not pass through the passage 172 of the tissue anchor 104 (see fig. 2B and 14). Thus, once severed, a portion of suture 106 passing through passage 172 is secured to tissue anchor 104 by blocking element 750 on one end and suture lock 110 on the other end, each of which cannot pass through passage 172.

The blocking element 750 may be any suitable structure that is securable to a suture and cannot pass through the channel 172. In the arrangement shown, the blocking element 750 is a metal strip that is placed over the suture 106 and may be crimped or otherwise secured in place at a particular location on the suture 106. Preferably, in the delivery method described above, the metal band 750 is threaded onto the suture 106 prior to threading the second tissue anchor 104 and suture lock 110 onto the suture 106. However, the metal strap 750 may also be attached after delivery of the two tissue anchors 102, 104 (including after delivery of the suture lock 110). Preferably, the metal band 750 is crimped after it has been moved to the implantation site. The metal band 750 may be crimped after the second tissue anchor 104 is delivered or implanted. In some cases, metal band 750 may be crimped after the entire remodeling system 100 is implanted and adjusted.

The position of metal strap 750 on suture 106 may affect the extent to which suture lock 110 is permitted to move. That is, the length of suture 106 between suture lock 110 and metal strip 750 affects or defines the extent to which suture lock 110 permits movement. Accordingly, it may be desirable for the metal strap 750 to be as close as possible or physically close to the tissue anchor 104 associated with the suture lock 110.

As indicated above, the blocking element 750 may be or include suitable structures other than a metal strip. For example, the blocking element 750 may be any type of clip having a body portion that is large enough to prevent the body portion from passing through the channel 172 of the tissue anchor. Other suitable blocking elements 750 may include retaining portions or functions that allow the blocking element 750 to be secured in place on the suture 160, as well as blocking portions or functions that prevent the blocking element 750 from passing through the channel 172 of the tissue anchor 104.

Conditional language as used herein, wherein like "may," "capable," "may," "might," "for example," etc., unless expressly stated otherwise or as otherwise understood from the context, is generally intended to convey that certain embodiments comprise certain features, elements and/or states, and other embodiments do not comprise certain features, elements and states. Thus, such conditional language is not generally intended to imply that features, elements, and/or states are in any way required for one or more embodiments.

The term "plurality" refers to two or more of an item. Recitation of amounts, dimensions, sizes, formulations, parameters, shapes, and other characteristics should be interpreted as if the term "about" or "approximately" preceded the amount, dimension, size, formulation, parameter, shape, or other characteristics. The term "about" or "approximately" means that the amounts, dimensions, sizes, formulations, parameters, shapes and other characteristics need not be exact, but may be approximated and/or larger or smaller, as desired, reflecting acceptable tolerances, conversion factors, rounding off, measurement error and the like, as well as other factors known to those of skill in the art. Recitation of amounts, dimensions, sizes, formulations, parameters, shapes, and other characteristics should be interpreted as if the term "substantially" were prior to the recited amounts, dimensions, sizes, formulations, parameters, shapes, or other characteristics. The term "substantially" means that the characteristic, parameter or value described is not necessarily to be achieved precisely, but rather that the quantity may deviate or vary, including, for example, tolerances, measurement errors, measurement accuracy limitations and other factors known to those of skill in the art, without excluding the effect that the characteristic is intended to provide.

Numerical data may be expressed or presented herein in a range format. It is to be understood that such range format is used merely for convenience and brevity and thus should be interpreted flexibly to include not only the numerical values explicitly recited as the limits of the range, but also to include all the individual numerical values or sub-ranges encompassed within that range as if each numerical value and sub-range is explicitly recited. By way of illustration, a numerical range of "1 to 5" should be construed to include not only the explicitly recited values of about 1 to about 5, but also to include individual values and subranges within the specified range. Accordingly, included within this numerical range are individual values such as 2, 3, and 4, as well as subranges such as "1 to 3", "2 to 4", and "3 to 5". This same principle applies to ranges reciting only one numerical value (e.g., "greater than 1") and applies regardless of the breadth of the range or the nature of the description.

For convenience, multiple items may be presented in a common list. However, these lists should be considered as if each member of the list is individually identified as a separate and unique member. Thus, without an opposite indication, individual members without this list should be interpreted as virtually equivalent to any other member of the same list based solely on their presentation in a common group. Furthermore, where the terms "and" or "are used in conjunction with a list of items, they are to be construed broadly, wherein any one or more of the listed items may be used alone or in combination with other listed items. The term "optionally" refers to the selection of one of two or more alternatives, and is not intended to limit the selection to only the listed alternatives or to only one of the listed alternatives at a time unless the context clearly indicates otherwise.

The application may also be said broadly to consist in the parts, elements and features referred to or indicated in the specification of the application, individually or collectively, in any or all combinations of two or more of said parts, elements or features.

It should be noted that various changes and modifications to the presently preferred embodiments described herein will be apparent to those skilled in the art. Such changes and modifications can be made without departing from the spirit and scope of the present application and without diminishing its attendant advantages. For example, the various components may be repositioned as desired. Accordingly, such changes and modifications are intended to be included within the scope of the present application. Furthermore, not all features, aspects, and advantages are required to practice the application. Accordingly, it is intended that the scope of the application be limited only by the claims appended hereto.

Claims (15)

1. A system for implanting a tissue anchor into cardiac tissue of a patient, the system comprising:

a delivery catheter comprising an anchor delivery tip, the tip comprising a fixed portion comprising a suture channel having a first end and a second end and a rotatable portion comprising a drive portion;

A tissue anchor comprising an anchor portion, a drive portion, and a suture mounting portion, wherein the anchor portion engages the cardiac tissue and is implanted by rotation about a longitudinal axis of the tissue anchor, wherein the anchor portion of the tissue anchor comprises one or more barbs, wherein the drive portion is rotatably fixed relative to the anchor portion and is configured to removably engage the drive portion of the catheter, wherein the suture mounting portion is rotatable relative to the anchor portion and the drive portion;

a suture secured to the suture mounting portion;

wherein the tissue anchor is configured to engage with the delivery catheter, the driving portion of the tissue anchor engaging with the driving portion of the delivery catheter;

wherein the suture extends through the suture channel of the tip of the delivery catheter such that the suture can be tensioned to prevent rotation of the suture mounting portion of the tissue anchor when the rotatable portion of the tip of the delivery catheter is rotated to rotate the drive portion and the anchor portion of the tissue anchor, thereby implanting the tissue anchor in the heart tissue.

2. The system of claim 1, wherein the suture channel of the fixed portion is located radially outward of the rotatable portion.

3. The system of claim 1, wherein the suture mounting portion is located between the drive portion and the anchor portion.

4. The system of claim 1, wherein the delivery catheter comprises a distal tip cap configured to surround the tissue anchor prior to deployment.

5. The system of claim 4, wherein the distal tip cap includes a slot through which the suture passes from an exterior of the distal tip cap to an interior of the distal tip cap such that the suture can be secured to the suture mounting portion.

6. The system of claim 5, wherein the distal tip cap comprises a slit extending from the slot to a distal end of the distal tip cap, wherein the slit is configured such that the suture can be moved from the slot, through the slit, and separated from the distal tip cap when the tissue anchor is deployed from the delivery catheter.

7. The system of claim 1, wherein each of the barbs comprises a tubular element having an angled end, a tip of the angled end being positioned radially outward.

8. A method of reshaping a mitral valve, the method comprising:

implanting a first tissue anchor at a first location at or near an annulus of a mitral valve of a patient using at least one catheter;

implanting a second tissue anchor at a second location opposite the first location at or near the annulus of the mitral valve of the patient using the at least one catheter;

extending a suture between the first and second tissue anchors and moving the first and second tissue anchors toward each other using the suture;

securing a tensioned length of the suture between the first tissue anchor and the second tissue anchor using a suture lock lockable using the at least one catheter;

observing the function of the mitral valve and, if necessary, unlocking the suture lock, increasing or decreasing the tension length of the suture, and relocking the suture lock;

the suture lock is permanently attached directly or indirectly to one of the first and second tissue anchors.

9. A tissue anchor, the tissue anchor comprising:

an anchor portion comprising a helical thread configured to be implanted in body tissue by rotation in a first direction about a longitudinal axis of the tissue anchor;

One or more barbs configured to permit rotation of the tissue anchor in the first direction and to inhibit rotation of the tissue anchor in a second direction opposite the first direction;

a drive portion rotatably fixed relative to the anchor portion, the drive portion configured to removably engage with a drive member of a catheter such that rotation of the drive member rotates the drive portion and the anchor portion of the tissue anchor;

a suture mounting portion configured to be connected to a suture at a suture mounting location.

10. The tissue anchor of claim 9 wherein the suture mounting portion is rotatable relative to the anchor portion and the drive portion.

11. The tissue anchor of claim 10, wherein the suture mounting portion is configured to rotate to align the suture mounting location with a direction of the suture force.

12. The tissue anchor of claim 11, wherein the suture mounting portion is located between the drive portion and the anchor portion along the longitudinal axis.

13. The tissue anchor of any one of claims 9-12, wherein the one or more barbs include a plurality of barbs spaced apart from one another along the length of the helical thread.

14. The tissue anchor of any one of claims 9-13, wherein each of the one or more barbs includes an angled end having a tip positioned radially outward on the barb.

15. The tissue anchor of any one of claims 9-14, wherein each of the one or more barbs is or includes a tubular element secured to the helical thread.