Systems and methods for tissue remodeling

Abstract

The invention relates to a system and method for tissue remodeling. Systems and methods for remodeling tissue, such as cardiac tissue. In some configurations, the systems and methods involve reshaping a mitral valve of a patient. Systems and methods may include a first tissue anchor, a second tissue anchor, a suture extending between the tissue anchors, and at least one suture lock that secures the suture or fixes the length of the suture relative to the tissue anchors. The systems and methods may also include a suture trimmer that may trim an excess portion of the suture. In some configurations, the suture lock is reversible to allow for iterative adjustment of the reshaping.

Description

[0001] This application is a divisional application. The application date of the original application is July 14, 2020, the application number is 2020800630052, and the name of the invention is “Systems and methods for tissue remodeling”. Background Art Technical Field

[0002] The present disclosure relates to systems and methods for remodeling tissue. In particular, the present disclosure relates to systems and methods for remodeling heart valves, such as mitral valve remodeling.

[0003] Description of related fields

[0004] Heart valves are located at the exit of each of the four heart chambers. Heart valves act as one-way valves to prevent blood from flowing in the wrong direction. Each valve has a set of flaps, called leaflets or cusps. Valve regurgitation is when blood leaks through a valve that is not completely closed, allowing blood to flow in both directions during contraction. Regurgitation can be caused by abnormalities in the leaflets themselves (called primary regurgitation), such as valve prolapse, damaged chordae tendineae, rheumatic fever, endocarditis, trauma, or congenital heart defects. On the other hand, in secondary regurgitation, the valve itself is intact and only the surrounding structures into which the leaflets insert are abnormal, causing regurgitation. Examples of secondary regurgitation are a history of heart attack, cardiomyopathy, long-term use of certain medications, radiation, atrial fibrillation, etc. Regurgitation can lead to congestive heart failure, which is the most common hospitalization diagnosis in the United States. Symptoms of congestive heart failure include fatigue, shortness of breath, and swelling of the feet and legs. Valvular regurgitation can lead to a vicious cycle of heart failure, arrhythmias, and worsening cardiomyopathy (weakening of the heart muscle), which causes more regurgitation.

[0005] Historically, open surgical valve repair or replacement was performed to treat diseases such as regurgitation. Recently, catheter-based techniques have been developed and introduced into clinical practice for repairing the mitral valve. In general, repair is considered superior to valve replacement to restore coaptation of the leaflets. Summary of the invention

[0006] The systems, methods and devices described herein have innovative aspects, no single one of which is essential or solely responsible for their desirable attributes.Without limiting the scope of the claims, some advantageous features will now be summarized.

[0007] One aspect of the present disclosure relates to a system for mitral valve remodeling, comprising a first tissue anchor and a second tissue anchor. The first tissue anchor is configured to be implanted in tissue at a first position at or near the annulus of a patient's mitral valve. The first tissue anchor comprises an anchoring portion, a driving portion, and a suture mounting portion. The anchoring portion engages tissue and is implanted by rotating around the longitudinal axis of the first tissue anchor. The driving portion is rotatably fixed relative to the anchoring portion and is configured to removably engage with a driving member of a catheter. The suture mounting portion is rotatable relative to the anchoring portion and the driving portion and is located between the driving portion and the anchoring portion along the longitudinal axis. The second tissue anchor is configured to be implanted in tissue at a second position at or near the annulus of the mitral valve opposite to the first position. The second tissue anchor comprises an anchoring portion, a driving portion, and a suture mounting portion. The anchoring portion engages tissue and is implanted by rotating around the longitudinal axis of the second tissue anchor. The driving portion is rotatably fixed relative to the anchoring portion and is configured to removably engage with a driving member of a catheter. The suture mounting portion is rotatable relative to the anchoring portion and the drive portion and is located between the drive portion and the anchoring portion along the longitudinal axis. The suture has a tensioning portion extending between a first suture mounting position on the suture mounting portion of the first tissue anchor and a second suture mounting position on the suture mounting portion of the second tissue anchor. The suture mounting portions of the first tissue anchor and the second tissue anchor rotate to align with each other in response to tension applied to the suture.

[0008] In embodiments, each of the first and second suture installation locations of the first and second tissue anchors includes a channel for receiving a suture, wherein a tensioning portion of the suture extends from an end of the channel relatively closer to the anchoring portion.

[0009] In embodiments, the suture lock is configured to secure a portion of the suture relative to the second tissue anchor to fix a length of the tensioned portion of the suture between the first tissue anchor and the second tissue anchor.

[0010] In an embodiment, a suture lock includes a first portion and a second portion movable relative to the first portion, wherein a lock portion of the suture is captured between the first portion and the second portion.

[0011] In an embodiment, the first portion includes a channel, wherein the lock portion of the suture passes through the channel.

[0012] In embodiments, the first portion of the suture lock is configured to contact the suture mounting portion of the second tissue anchor to fix the length of the tensioned portion of the suture.

[0013] In embodiments, when the suture lock is in contact with the second tissue anchor, the channel of the suture lock is aligned with the channel of the second suture installation location of the second tissue anchor.

[0014] In an embodiment, the first portion of the stitch lock is rotationally fixed relative to the second portion.

[0015] In an embodiment, the threaded fastener is configured to move a first portion of the stitch lock relative to a second portion.

[0016] In an embodiment, the threaded fastener is configured to move the first portion of the stitch lock toward and away from the second portion.

[0017] In an embodiment, the suture cutter is configured to cut a suture.

[0018] In an embodiment, the suture cutter includes a tip having an axial slot and a radial channel, wherein the axial slot intersects the radial channel, wherein the suture passes through the radial channel, and the suture cutter further includes a blade movable within the slot to cut the suture.

[0019] Aspects of the present disclosure relate 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 stationary portion and a rotatable portion. The stationary portion includes a suture channel having a first end and a second end. The rotatable portion includes a drive portion. The system further includes a tissue anchor including an anchor portion, a drive portion, and a suture mounting portion. The anchor portion engages cardiac tissue and is implanted by rotating 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 with a 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 with the delivery catheter, wherein the drive portion of the tissue anchor engages with the drive portion of the delivery catheter. The suture extends through a suture channel at the tip of the delivery catheter so that the suture can be tensioned to prevent the suture mounting portion of the tissue anchor from rotating when the rotatable portion of the tip of the delivery catheter is rotated to rotate the drive portion and anchor portion of the tissue anchor to implant the tissue anchor into the cardiac tissue.

[0020] In an embodiment, the suture channel of the stationary portion is located radially outward of the rotatable portion.

[0021] In an embodiment, the suture mounting portion is located between the actuation portion and the anchoring portion.

[0022] In an embodiment, the delivery catheter includes a distal tip covering configured to surround the tissue anchor prior to deployment.

[0023] In an embodiment, the distal tip cover includes a slot, wherein a suture passes through the slot from the exterior of the distal tip cover to the interior of the distal tip cover so that the suture can be secured to the suture mounting portion.

[0024] In an embodiment, the distal tip cover includes a slit extending from the slot to the distal end of the distal tip cover, wherein the slit is configured such that a suture can be moved from the slot, through the slit, and separated from the distal tip cover when the tissue anchor is deployed from the delivery catheter.

[0025] Aspects of the present disclosure relate to a tissue anchor comprising an anchoring portion comprising a helical thread configured to be implanted in body tissue by rotating around a longitudinal axis of the tissue anchor. The tissue anchor further comprises a drive portion rotatably fixed relative to the anchoring portion. The drive portion is configured to removably engage with a drive member of a catheter so that rotation of the drive member rotates the drive portion and the anchoring portion of the tissue anchor. The tissue anchor further comprises a suture mounting portion, which is rotatable relative to the anchoring portion and the drive portion. The suture mounting portion is configured to be connected to a suture at a suture mounting position. The suture mounting portion is configured to rotate so that the suture mounting position is aligned with the direction of force of the suture. The suture mounting portion is located between the drive portion and the anchoring portion along the longitudinal axis.

[0026] In an embodiment, the helical thread of the anchoring portion is a helical coil defining a hollow interior space.

[0027] In an embodiment, the helical coil comprises a circular cross-sectional shape.

[0028] In an embodiment, the drive portion defines a radially outwardly facing drive surface configured to engage a drive member of the catheter.

[0029] In an embodiment, the drive portion comprises a square cross-sectional shape defining a radially outwardly facing drive surface.

[0030] In embodiments, the suture mounting portion has a peripheral surface surrounding the longitudinal axis of the tissue anchor, the peripheral surface defining a geometric center of the suture mounting portion, wherein the axis of rotation of the suture mounting portion is spaced apart from the geometric center.

[0031] In an embodiment, the suture installation location is on the opposite side of the geometric center from the axis of rotation.

[0032] In embodiments, the suture installation location includes a channel extending through the suture installation portion in a direction substantially aligned with the longitudinal axis of the tissue anchor.

[0033] In an embodiment, the length of the anchoring portion along the longitudinal axis is greater than the length of one or both of the actuation portion and the suture mounting portion.

[0034] In an embodiment, the length of the actuation portion is greater than the length of the suture mounting portion.

[0035] Aspects of the present disclosure relate to a tissue anchor comprising an anchoring portion comprising a helical thread configured to be implanted in body tissue by rotating around a longitudinal axis of the tissue anchor. The tissue anchor further comprises a drive portion rotatably fixed relative to the anchoring portion. The drive portion is configured to removably engage with a drive member of a catheter so that rotation of the drive member rotates the drive portion and the anchoring portion of the tissue anchor. The tissue anchor further comprises a suture mounting portion rotatable relative to the anchoring portion and the drive portion. The suture mounting portion is configured to be connected to a suture at a suture mounting position. The suture mounting portion is configured to rotate so that the suture mounting position is aligned with the direction of force of the suture. The suture mounting portion is located above the anchoring portion along the longitudinal axis. The suture mounting portion has a first end face and a second end face opposite to the first end face. The second end face is closer to the anchoring portion along the longitudinal axis than the first end face. The suture mounting portion is configured so that the suture extends from the tissue anchor at or below the second end face.

[0036] In an embodiment, the suture mounting portion is located proximate to the anchoring portion.

[0037] In an embodiment, the helical thread of the anchoring portion is a helical coil defining a hollow interior space.

[0038] In an embodiment, the helical coil comprises a circular cross-sectional shape.

[0039] In an embodiment, the drive portion defines a radially outwardly facing drive surface configured to engage a drive member of the catheter.

[0040] In an embodiment, the drive portion comprises a square cross-sectional shape defining a radially outwardly facing drive surface.

[0041] In embodiments, the suture mounting portion has a peripheral surface surrounding the longitudinal axis of the tissue anchor, the peripheral surface defining a geometric center of the suture mounting portion, wherein the axis of rotation of the suture mounting portion is spaced apart from the geometric center.

[0042] In an embodiment, the suture installation location is on the opposite side of the geometric center from the axis of rotation.

[0043] In embodiments, the suture installation location includes a channel extending through the suture installation portion from the first end surface to the second end surface in a direction substantially aligned with the longitudinal axis of the tissue anchor.

[0044] In an embodiment, the length of the anchoring portion along the longitudinal axis is greater than the length of one or both of the actuation portion and the suture mounting portion.

[0045] In an embodiment, the length of the actuation portion is greater than the length of the suture mounting portion.

[0046] Aspects of the present disclosure relate to a suture lock for a tissue remodeling system. The suture lock includes a first portion including a base flange and a hub extending axially from the base flange. The base flange includes a suture channel configured to accommodate sutures of the tissue remodeling system. The suture lock also includes a second portion including an end wall and at least one side wall that defines a space that slidably engages the hub of the first portion. The end wall and the at least one side wall are configured to prevent the first portion from rotating when the hub is positioned in the space. The second portion further includes a clamping surface that is located near the end of the suture channel of the base flange and is configured to clamp a portion of the suture against the base flange to secure the suture relative to the suture lock. The second portion can move toward and away from the first portion to selectively clamp and release the suture.

[0047] In an embodiment, the at least one side wall includes a first side wall and a second side wall, wherein the first side wall and the second side wall are parallel and spaced apart from each other to receive the hub therebetween.

[0048] In an embodiment, the first portion includes an axially extending threaded cavity in the hub and the second portion includes an opening in the end wall, the stitch lock further including a threaded fastener passing through the opening and threadingly engaging the threaded cavity, wherein the threaded fastener is configured to move the first portion toward the second portion in response to rotation in a first direction and to allow the first portion to move away from the second portion in response to rotation in a second direction.

[0049] Aspects of the present disclosure relate to a method for reshaping a mitral valve. The method includes implanting a first tissue anchor at a first location at or near a mitral valve annulus of a patient using at least one catheter. The method further includes implanting a second tissue anchor at a second location at or near a mitral valve annulus of the patient opposite the first location using at least one catheter. The method also includes extending a suture between the first tissue anchor and the second tissue anchor and using the suture to move the first tissue anchor and the second tissue anchor toward each other. The method includes fixing a tensioned length of the suture between the first tissue anchor and the second tissue anchor using a suture lock, which suture lock can be locked using at least one catheter. The method further includes observing the function of the mitral valve and, if necessary, unlocking the suture lock, increasing or decreasing the tensioned length of the suture, and relocking the suture lock.

[0050] In an embodiment, the method further comprises cutting an excess portion of the suture using a suture cutter.

[0051] Aspects of the present disclosure relate to a method for tensioning a suture of a mitral valve remodeling system. The method includes slidably engaging a suture lock with a suture having an end fixed to a first tissue anchor implanted at a first location at or near the mitral valve annulus and slidably engaging a second tissue anchor implanted at a second location at or near the mitral valve annulus. The method further includes using a catheter to slide the suture lock along the suture toward the second tissue anchor until the suture lock contacts the second tissue anchor. The method also includes applying tension to the suture while maintaining contact between the suture lock and the second tissue anchor to tension the portion of the suture extending between the first tissue anchor and the second tissue anchor.

[0052] In embodiments, the method further comprises locking a suture lock onto the suture to maintain tension on the portion of the suture extending between the first tissue anchor and the second tissue anchor.

[0053] In an embodiment, the method further comprises disengaging the catheter from the stitch lock after the stitch lock is locked onto the suture. BRIEF DESCRIPTION OF THE DRAWINGS

[0054] Reference numerals may be reused throughout the drawings to indicate a general correspondence between reference elements.The drawings are provided to illustrate example implementations described herein and are not intended to limit the scope of the present disclosure.

[0055] Figure 1 is a perspective view of a mitral valve remodeling system implanted in a patient's mitral valve.

[0056] Figure 2 yes Figure 1 Perspective view of the tissue anchor of the system.

[0057] Figure 2A yes Figure 2 Side view of a tissue anchor.

[0058] Figure 2B yes Figure 2 A top view of the suture mounting portion of a tissue anchor.

[0059] Figure 3 yes Figure 1 Perspective view of the stitch lock system.

[0060] Figure 4 yes Figure 3 Cross-sectional view of a suture lock.

[0061] Figure 5 Is implanted Figure 1 View of the guide catheter and delivery catheter used in the system.

[0062] Figure 6 yes Figure 5 Perspective view of a delivery catheter.

[0063] Figure 7 is a perspective view of a first tissue anchor implanted at a first location in a mitral valve of a patient.

[0064] Figure 8 is a perspective view of a second tissue anchor implanted at a second location in a mitral valve of a patient.

[0065] Fig. 8A is a partial cross-sectional view of the tip of a delivery catheter for delivering a tissue anchor.

[0066] Fig. 9 is a perspective view of a suture lock placed at a second location in a mitral valve of a patient.

[0067] Fig. 9A is a cross-sectional view of the tip of a delivery catheter used to deliver a suture lock.

[0068] Fig.10 is a perspective view of the excess portion of the seam being trimmed.

[0069] Fig.11 A process flow diagram of a method for implanting and optionally adjusting a mitral valve remodeling system.

[0070] Fig. 12A is a perspective view of a portion of an alternative delivery catheter having a distal tip covering in which a tissue anchor is stowed.

[0071] Fig. 12B A tissue anchor is shown deployed from the distal tip covering with a suture extending through a slot in the distal tip.

[0072] Fig. 12C The suture is shown passing through the slit in the distal tip covering. DETAILED DESCRIPTION

[0073] Embodiments of systems, components, and assembly and manufacturing methods will now be described with reference to the accompanying drawings, wherein the same reference numerals refer to the same or similar elements throughout. Although several embodiments, examples, and descriptions are disclosed below, it will be understood by those of ordinary skill in the art that the invention described herein extends beyond the specifically disclosed embodiments, examples, and descriptions, and may include other uses of the invention and obvious modifications and equivalents thereof. The terms used in the descriptions presented herein are not intended to be interpreted in any limited or restrictive manner simply because they are used in conjunction with the detailed descriptions of certain specific embodiments of the invention. In addition, embodiments of the present invention may include several novel features, and no single feature is solely responsible for its desired attributes or is essential to practicing the invention described herein.

[0074] Certain terms may be used in the following description for reference purposes only and are 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 position of parts of a component or element within a consistent but arbitrary reference system, which can be clearly accomplished by reference to the text and related drawings describing the component or element in question. In addition, terms such as "first," "second," "third," etc. may be used to describe individual components. Such terms may include the words specifically mentioned above, their derivatives, and words of similar meaning.

[0075] The percutaneous technique described in this application is designed to treat valvular regurgitation by structurally altering the heart to increase leaflet coaptation. The technique can be applied to the atrioventricular valves of the heart (mitral and tricuspid). The concept of repair is an annular approach to valve repair.

[0076] One or more embodiments of the technology described in this application have several advantages over currently commercially available or currently developed experimental technologies. These advantages include one or more of the following:

[0077] 1. In one or more embodiments, the disclosed technology allows for personalized regurgitation reduction based on the underlying pathology and valve size (specifically, where the anchor is placed and how much the cable is tethered). From a practical perspective, the disclosed technology eliminates the need for hospitals to acquire a large number of devices of different sizes. Essentially the only equipment required is the delivery catheter, anchor, and cable.

[0078] 2. The disclosed technology may conceptually be particularly helpful in patient populations that have not been studied to date, such as those with secondary mitral regurgitation due to atrial disease 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.

[0079] 3. In one or more embodiments, the disclosed techniques can be used as an adjunct to existing techniques (edge-to-edge repair) in situations where suboptimal results exist or are expected.

[0080] 4. A further advantage of one or more embodiments of the disclosed technology is that it can allow for other, future catheter-based valve repair or replacement strategies due to the ability to cut the repair cord.

[0081] 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 profiles compared to open surgical repair or replacement.

[0082] 6. The simplicity of the disclosed technology is striking when compared to other currently available or tested repair devices. Due to its simple design, the operation time and learning curve may be favorable.

[0083] 7. Finally, the smaller entry of the delivery system of one or more embodiments of the disclosed technology may eliminate concerns about residual iatrogenic atrial septal defects after percutaneous, transseptal access for mitral valve repair and allow easy access via the right internal jugular vein for tricuspid valve repair.

[0084] The accompanying drawings illustrate systems and methods for stabilizing or reshaping tissue. Preferably, the disclosed systems and methods are configured for reshaping soft tissue, such as cardiac tissue. The illustrated systems and associated methods are configured for reshaping a mitral valve. However, the systems, 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.

[0085] The system shown is configured for percutaneous pervascular delivery using one or more catheters or other suitable conduits. However, in alternative arrangements or applications, the system or its components as disclosed or modified by those skilled in the art can be delivered to or installed at a desired body location by other means (e.g., by using direct access).

[0086] System Overview

[0087] 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. The suture 106 extends between the first tissue anchor 102 and the second tissue anchor 104. The suture 106 can be secured relative to the first tissue anchor 102 and the second tissue anchor 104 to fix the distance between the tissue anchors 102, 104. The distance between the anchors 102, 104 can be adjusted to achieve a desired level of performance of the mitral valve. The suture lock 110 secures the suture 106 relative to the second tissue anchor 104 to maintain the desired distance between the anchors 102, 104.

[0088] The first tissue anchor 102 is implanted at a first location 112 in the patient's heart tissue, which may be at or near the 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 so that under normal or expected conditions, the tissue has sufficient strength to support the tissue anchors 102, 104 without tearing or otherwise being damaged.

[0089] In the illustrated arrangement, the first tissue anchor 102 and the second tissue anchor 104, or the first position 112 and the second position 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 in a central region along the direction of the sealing edge 126 of the mitral valve 114 or at or near the midpoint of the posterior leaflet 122. The second tissue anchor 104 may be located in a central region along the direction of the sealing edge 126 of the mitral valve 114 or at or near the midpoint of the anterior / posterior leaflets 124.

[0090] The suture 106 has a first end 130 secured to the first tissue anchor 102. As used herein, the term suture may refer to any suitable thread capable of connecting the tissue anchors 102, 104 and, unless otherwise specified, maintaining the tissue anchors 102, 104 at an adjusted separation distance (e.g., without stretching) under expected conditions and for the expected life of the system 100. The suture 106 extends from the first tissue anchor 102 to the second tissue anchor 104. The suture 106 engages the second tissue anchor 104 so as to allow relative movement between the suture 106 and the second tissue anchor 104. In the illustrated configuration, the suture 106 slides within or relative to the second tissue anchor 104. The length of the suture 106 located 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 can be adjusted to achieve a desired level of remodeling of the mitral valve 114 or a desired performance of the mitral valve 114 .

[0091] The suture lock 110 can be secured in a desired position along the length of the portion of the suture 106 that is not located between the tissue anchors 102, 104. The suture lock 110 can 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 reshape 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 apply a force in a direction tending to move the anchors 102, 104 apart, thereby tensioning the portion of the suture 106 located between the first tissue anchor 102 and the second tissue anchor 104. Therefore, this portion of the suture 106 may be referred to herein as a tensioning length 132. Therefore, in some configurations, the suture lock 110 is retained against the second tissue anchor 104 by the tension of the tensioning length 132 of the suture 106. The stitch lock 110 merely fixes the maximum separation distance of the first and second tissue anchors 102, 104, but allows the tissue anchors 102, 104 to move closer to each other.

[0092] In some configurations, as further described below, the stitch lock 110 is reversible. That is, the stitch lock 110 can be secured in one position along the length of the suture 106 to define a desired tensioned length 132. The performance of the mitral valve 114 can then be observed, and if necessary, the stitch lock 110 can be released from the suture 106, moved to another position and secured to the suture 106 again to define a different tensioned length 132. This process can be repeated until the desired level of remodeling or performance of the mitral valve 114 is achieved.

[0093] Tissue anchors

[0094] In some configurations, the tissue anchors 102, 104 are identical or substantially identical to one another. Thus, a first tissue anchor 102 is described. The second tissue anchor 104 can be identical or substantially identical, or can be another suitable arrangement.

[0095] The illustrated tissue anchor 102 includes an anchor portion 140, an actuation portion 142, and a suture mounting portion 144 disposed along a longitudinal axis 148 of the tissue anchor 102. In some configurations, the suture mounting portion 144 is located proximate to the anchor portion 140. In the illustrated configuration, the suture mounting portion 144 is located between the anchor portion 140 and the actuation portion 142 along the longitudinal axis 148.

[0096] The anchoring portion 140 is configured to be implanted in tissue. Preferably, the anchoring portion 140 is configured to be implanted in soft tissue, such as cardiac tissue. In some configurations, the anchoring portion 140 is a threaded member that is implanted by rotating around a longitudinal axis 148. The anchoring portion 140 shown includes a spiral member 150. The spiral member 150 includes an elongated member having a circular cross-section that is wound around the longitudinal axis 148 to define an elongated hollow space 152 extending along the longitudinal axis 148. The anchoring portion 140 defines a length 151 sufficient to secure the anchoring portion 140 in the desired tissue.

[0097] The drive portion 142 is configured to be engaged by a catheter or other implantation tool to allow implantation of the tissue anchor 102. The drive portion 142 is fixed for rotation with the anchor portion 140 such that rotation of the drive portion 142 causes rotation of the anchor portion 140.

[0098] The drive portion 142 includes a drive surface 154 configured to engage with a drive member of a catheter. In the illustrated arrangement, the shape of the drive surface 154 is non-circular. In the illustrated arrangement, the drive surface 154 is defined by an outwardly facing surface of the drive portion 142. The drive surface 154 is configured to engage with an inwardly facing surface of a drive member of a catheter. The drive surface 154 shown has a square shape in a plane perpendicular to the longitudinal axis 148. However, other shapes may also be used. In addition, although the drive surface 154 shown is an outwardly facing surface, the drive surface 154 may be defined by, for example, an inwardly facing surface of a tool cavity.

[0099] The drive portion 142 defines a length 156 that is sufficient to allow the drive portion 142 to be engaged by a drive member of a tool, such as a catheter. In some configurations, the length of the drive surface 154 is equal to the length 156 of the drive portion 142 .

[0100] The suture mounting portion 144 is movable relative to one or both of the anchor portion 140 and the drive portion 142. In some configurations, the suture mounting portion 144 is movable relative to both of the anchor portion 140 and the drive portion 142. In the illustrated arrangement, the suture mounting portion 144 is rotatable relative to one or both of the anchor portion 140 and the drive portion 142. Preferably, the suture mounting portion 144 is rotatable about the longitudinal axis 148 of the tissue anchor 102.

[0101] In some configurations, the suture mounting portion 144 includes a cylindrical body portion 158 having a relatively small length 160 or dimension extending along the longitudinal axis 148. In some configurations, the length 160 is less than the diameter 162 or the largest dimension in a direction perpendicular to the longitudinal axis 148. The body portion 158 includes a cylindrical sidewall 164 that defines an outer 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 148. 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.

[0102] The suture mounting portion 144 includes a suture mounting location 170 that is configured to connect, engage, or otherwise support a suture, wire, or other tensioning member. The suture mounting location 170 allows the suture 106 to extend from the tissue anchor 102 in a direction that is generally perpendicular to the longitudinal axis 148. As used herein, the suture 106 extending in a generally perpendicular direction means that the suture 106 is oriented closer to a perpendicular direction than a parallel direction.

[0103] In some configurations, the suture mounting location 170 is configured to allow the suture mounting portion 144 and the tissue anchor 102 to slide over the suture 106. In the illustrated arrangement, the suture mounting location 170 includes a channel 172 extending through the body portion 158 of the suture mounting portion 144 from a first surface 174 to a second surface 176. The first surface 174 is closer to the drive 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 perpendicular to the longitudinal axis 148. The channel 172 of the first tissue anchor 102 allows the suture 106 to be tied or otherwise fixedly 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 so that the tensioning length 132 can be adjusted. As used herein, the term connected when used to describe the interaction between the suture 106 and the suture mounting portion 144 may encompass both situations unless otherwise specified.

[0104] Preferably, the channel 172 is located on the 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 the force acting on the suture 106. The body portion 158 protrudes a greater distance from the longitudinal axis 148 on the side of the channel 172 than on the side opposite the channel 172. In the illustrated arrangement, the suture 106 extends from the end of the channel 172 closest to the 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.

[0105] In some configurations, the length 151 of the anchor portion 140 is greater than one or both of the length 156 of the actuation portion 142 and the length 160 of the suture mounting portion 144. In the illustrated arrangement, the length 151 of the anchor portion 140 is greater than both the length 156 of the actuation portion 142 and the length 160 of the suture mounting portion 144. In some configurations, the length 156 of the actuation portion 142 is greater than the length 160 of the suture mounting portion 144.

[0106] Seam lock

[0107] The stitch lock 110 includes a first portion or base 180. A second portion or cap 182 of the stitch lock 110 is movable relative to the base 180 along a longitudinal axis 184 of the stitch lock 110. The base 180 and the cap 182 are rotationally fixed relative to each other. A 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 stitch lock 110 can clamp the lock 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 stitch lock 110 relative to the suture 106, and then re-clamp the suture 106.

[0108] The base 180 and the cap 182 include cooperating structures that inhibit or prevent relative rotation. The cooperating structures can be one or more flat surfaces or non-circular surfaces relative to the longitudinal axis 184.

[0109] In the illustrated arrangement, the base 180 is generally cylindrical in shape. The base 180 includes a protruding portion in the form of a central hub 200 that defines at least one non-circular surface (e.g., a flat surface 202). In the illustrated arrangement, the hub 200 defines a pair of flat surfaces 202 spaced apart from each other on opposite sides of the longitudinal axis 184. The illustrated base 180 is symmetrical about the longitudinal axis 184. Thus, the illustrated flat surfaces 202 are equidistant from the longitudinal axis 184. As used herein with respect to structures that inhibit or prevent rotation, a non-circular surface is a surface in which a surface can cooperate with another surface to inhibit or prevent rotation about a longitudinal axis 184. Such a surface may include, for example, a flat surface or a curved surface having a curvature about a center that is not located on the longitudinal axis 184.

[0110] The flat surfaces 202 each have at least a portion extending in a direction parallel to the longitudinal axis 184. In the illustrated arrangement, the flat surfaces 202 are each oriented parallel to the longitudinal axis 184. Thus, the flat surfaces 202 allow the cap 182 to move axially relative to the base 180, but inhibit or prevent rotational movement of the cap 182 relative to the base 180.

[0111] Each flat surface 202 is created by a section of a cylindrical workpiece that extends only partially through the workpiece in the longitudinal direction, such that the base 180 also includes at least one flange portion or base flange 204. In the illustrated arrangement, the base 180 includes a pair of flange portions, which for convenience are hereinafter referred to as flanges 204. Each flange 204 defines a shoulder surface or shoulder 206 adjacent the flat surface 202. The shoulders 206 provide a stop surface to limit axial movement of the cap 182 along the longitudinal axis 184. The shoulders 206 also provide a surface against which the suture 106 can be clamped, as described further below.

[0112] The cap 182 is generally cylindrical in shape with a 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 cap 182 shown defines an end wall portion 212 and a pair (e.g., first and second) of depending side wall portions 214 that cooperate to define the space 210. The end wall portion 212 defines the opening 190 through which the threaded fastener 186 passes. The first and second side wall portions 214 each define a surface 216 that cooperates with one of the flat 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 illustrated arrangement, the surface 216 of the side wall portion 214 is flat. Therefore, in the illustrated arrangement, both the surface 202 and the surface 216 of the base 180 are flat. However, other arrangements are possible in which only one of the surfaces 202, 216 is flat, or in which neither of the surfaces 202, 216 is flat but is otherwise configured to cooperate with one another to inhibit or prevent rotation between the base 180 and the cap 182. The flat surface 216 of the cap 182 is shown in sliding contact with the flat surface 202 of the base 180 to allow axial movement and inhibit or prevent rotational movement of the cap 182 relative to the base 180.

[0113] The end of the side wall portion 214 opposite the end wall portion 212 terminates in an outwardly or radially extending flange 220. The portion of the side wall portion 214 adjacent the flange 220 defines a flat surface 222. The flat surfaces 222 are parallel to each other in the illustrated arrangement, but may be non-parallel in other configurations. The flat surface 222 is positioned radially inward from the outermost extent of the flange 220 to define a stop surface or shoulder 224. The flat surface 222 can be utilized so that a tool (e.g., a catheter) can retain the cap 182 from rotating while the threaded fastener 186 is rotated to move the base 180 and the cap 182 toward or away from each other along the longitudinal axis 184.

[0114] As described above, the suture 106 can be captured or clamped between the base 180 and the cap 182. The suture 106 can be captured or clamped between the flange 204 of the base 180 and the corresponding flange 220 of the cap 182. In some configurations, one or both of the base 180 and the cap 182 include a suture retention feature that is configured to retain the suture 106 to the base 180 and / or the cap 182 or at least inhibit or prevent complete separation of the suture 106 from the base 180 and / or the cap 182. In the illustrated arrangement, at least one of the flanges 204 of the base 180 includes a suture channel 226 configured to accommodate the suture 106. However, in other arrangements, at least one of the flanges 220 of the cap 182 or both of the one or more flanges 204 of the base 180 and the one or more flanges 220 of the cap 182 can include a suture channel 226.

[0115] In the illustrated arrangement, the suture channel 226 extends from the end face 230 through the flange 204 to the shoulder surface 206. In some configurations, the channel 226 extends in a direction generally parallel to the longitudinal axis 184. As used herein, generally parallel means that the channel 226 is oriented closer to a parallel direction than a perpendicular direction. The channel 226 allows the suture 106 to be retained on 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, so that the suture 106 can be selectively clamped by moving the cap 182 toward the base 180.

[0116] The threaded fastener 186 may be or may be similar to a hexagon socket head bolt. The threaded fastener 186 has a threaded shank portion or shank 232 and a head portion or head 234. The head 234 has a larger diameter or cross-sectional size than the shank 232. The head 234 may define one or more surfaces configured to engage a tool. In the illustrated arrangement, the head 234 defines a tool cavity 236, such as a hexagonal tool cavity. The shank 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 hold the cap 182 on the base 180. As previously described, the 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.

[0117] Delivery catheter

[0118] As previously described, the system 100 utilizes one or more catheters to deliver and implant or install the components of the system 100 within the desired anatomical structure of the patient, such as the mitral valve 114 of the heart in the illustrated application. The catheter can be a steerable catheter known in the art. In some implementations, 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 to the patient's heart. The delivery catheter 250 is configured to implant the tissue anchors 102, 104 into the desired tissue of the patient, such as the mitral valve 114.

[0119] The delivery catheter 250 includes an elongated catheter body or tube 252. A handle 254 can be connected to the outer end of the tube 252 and can 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 that is configured to engage the tissue anchors 102, 104. The tip 256 shown has a first portion 260 and a second portion 262. The first portion 260 is a stationary portion 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 therefore relative to the tube 252.

[0120] The delivery catheter 250 includes a drive element that is configured to selectively rotate the second portion 262 of the tip 256. In the illustrated arrangement, the drive element is an elongated drive rod 264 that extends from the handle 254 through the tube 252 to the second portion 262 of the tip 256. The drive rod 264 is coupled to the second portion 262 of the tip 256 in a manner such that torque can be transferred from the drive rod 264 to the second portion 262 of the tip 256. Thus, rotation of the drive rod 264 causes rotation of the second portion 262 of the tip 256. Rotation of the drive rod 264 can be actuated by the handle 254, such as via a dial or knob 266 or other suitable control member. Figure 7 The handle 254 in FIG. 2 is not shown to scale.

[0121] The first portion 260 of the tip 256 may have a diameter or cross-sectional dimension that is greater than the diameter or cross-sectional dimension of the second portion 262 of the tip 256 and / or the tube 252. Preferably, the first portion 260 of the tip 256 has a diameter or cross-sectional dimension that is greater than the diameter or cross-sectional dimension of both the second portion 262 of the tip 256 and the tube 252. The first portion 260 of the tip 256 may include a suture channel 270 configured to accommodate the suture 106. The suture channel 270 may extend generally along the axial direction of the delivery catheter 250. Preferably, the delivery catheter 250 is a "rapid exchange" type catheter, in which the suture 106 passes only through a small portion of the catheter 250, and is otherwise external to the catheter 250. In the illustrated configuration, the suture 106 passes only through the suture channel 270 of the tip 256 and is completely external to the tube 252.

[0122] The second portion 262 of the tip 256 defines an engagement portion that is 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 that is configured to receive the drive portion 142 of the tissue anchors 102, 104. The tool cavity 272 and the drive portion 142 each have a non-circular cross-sectional shape that complements each other. In the illustrated arrangement, each of the tool cavity 272 and the drive portion 142 has a square cross-sectional shape. Therefore, the drive portion 142 of the tissue anchors 102, 104 can slide into the tool cavity 272 of the second portion 262 of the tip 256. Therefore, the tissue anchors 102, 104 can be selectively engaged and disengaged with the tip 256 of the delivery catheter 250. Additionally, rotation of the second portion 262 of the tip 256 causes rotation of the drive portion 142 of the tissue anchors 102 , 104 .

[0123] The illustrated system 100 also includes a suture lock delivery catheter 280 configured to deliver and install the suture lock 110. The delivery catheter 280 can be similar to the delivery catheter 250 that delivers the tissue anchors 102, 104. The illustrated delivery catheter 280 includes an elongated catheter body or tube 282. A handle 284 can be connected to the outer end of the tube 282 and can 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.

[0124] The tip 286 may have a diameter or cross-sectional dimension that is greater than the diameter or cross-sectional dimension of the tube 282. The tip 286 may include a suture channel 290 configured to receive the suture 106. The suture channel 290 may extend generally along the axial direction of the delivery catheter 280. Preferably, the delivery catheter 280 is a "rapid exchange" type catheter, in which the suture 106 passes only through a small portion of the catheter 280, and is otherwise external to the catheter 280. In the illustrated configuration, the suture 106 passes only through the suture channel 290 of the tip 286 and is entirely external to the tube 282.

[0125] The tip 286 defines an engagement portion that is configured to engage the suture lock 110. Specifically, the tip 286 is configured to retain the cap 182 of the suture lock 110 and inhibit or prevent the cap 182 from rotating, so that the threaded fastener 186 can rotate relative to the cap 182 to move the base 180 toward or away from the cap 182. In the illustrated arrangement, the tip 286 defines a cavity 292 configured to receive the cap 182 of the suture lock 110. The cavity 292 includes an engagement surface 294 that engages the flat surface 222 of the cap 182 of the tissue anchor 110. Therefore, the cap 182 of the suture lock 110 can slide into the cavity 292 of the tip 286. Therefore, the cap 182 of the suture lock 110 can be selectively engaged and disengaged with the tip 286 of the delivery catheter 280. In addition, the tip 286 can retain the cap 182 of the suture lock 110 from rotating.

[0126] The delivery catheter 250 includes a drive element configured to selectively rotate the threaded fastener 186 of the suture lock 110. In the illustrated arrangement, the drive element is an elongated drive rod 296 that extends from the handle 284 through the tube 282 to the tip 286. The drive rod 296 carries a drive element, such as a drive tip or drive tool 298, that is configured to transfer torque from the drive rod 296 to the threaded fastener 186. In the illustrated arrangement, the drive tool 298 has a shape that is complementary to the tool cavity 236 of the threaded fastener 186. Thus, rotation of the drive rod 296 causes rotation of the threaded fastener 186. Rotation of the drive rod 296 can be actuated from the handle 284, such as via a dial or knob 300 or other suitable control member. Fig. 9 The handle 284 in FIG. 2 is not shown to scale.

[0127] Seam trimmer

[0128] The system 100 may also include a suture trimmer 350 configured to cut or trim excess portions of the suture 106. In the illustrated arrangement, the 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 trimming end of the tube 352 inserted into the patient includes a tip 356 configured to trim the suture 106.

[0129] The tip 356 shown 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 hold the suture 106 to be cut by the cutting blade 354. The second portion 362 defines a suture channel 366 configured to accommodate the suture 106. The suture channel 366 extends in a radial or substantially radial direction of the tube 352. That is, the suture channel 366 can extend in a radial direction or in a direction oblique to the longitudinal axis of the tube 352.

[0130] The second portion 362 of the tip 356 shown also includes a slot 370, which is configured to receive a cutting blade 364 when the second portion 362 moves axially toward the first portion 360. The slot 370 intersects with the suture channel 366. Therefore, when the suture 106 is located in the suture channel 366, the cutting blade 364 can move into the slot 370 to cut the suture 106 by the movement of the second portion 362 of the tip 356 toward the first portion 360. In the illustrated arrangement, the slot 370 extends through the end of the second portion 362 of the tip 356. However, in other arrangements, the slot 370 can have a closed end. In other arrangements, the second portion 362 of the tip can be stationary and the blade 364 can be configured to move.

[0131] The suture trimmer 350 includes an actuator for moving the second portion 362 toward the first portion 360 to advance the cutting blade 364 into the slot 370. In the illustrated arrangement, the suture trimmer 350 includes an actuating wire or rod 372. The actuating 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 joystick 374, can be located on the handle 374 and coupled to the actuating wire 372. The control element 374 can exert a pulling force on the actuating wire 372, tending to move the second portion 362 of the tip 356 in an axial direction toward the first portion 360. As a result, the cutting blade 364 is advanced through the slot 370 to cut the suture 106. Fig.10 The handle 354 in FIG. 3 is not shown to scale.

[0132] Advantageously, the arrangement shown allows trimming of the suture 106 at a location proximal to the suture lock 110. As a result, a relatively short length of excess suture 106 is left in the patient. For example, if the slot 370 is located in the center of the tube 352 or the tip 356 and the suture channel 366 is oriented in a radial direction of the tube 352 or the tip 356, the excess portion of the suture 106 can be equal to or less than the radius of the tip 356, such as the second portion 362 of the tip 356. Thus, the second portion 362 of the tip 356 can be configured to have a smaller diameter or cross-sectional size than one or both of the first portion 360 of the tip 356 and the tube 352.

[0133] method

[0134] The components of the system 100 can be delivered to the patient's mitral valve 114 by any suitable method. In some configurations, the components of the system 100 are delivered 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 vena cava or the superior vena cava. The guide catheter 310 can be delivered to the left atrium by any suitable method, such as any transvascular approach known in the art. The guide catheter 310 can be configured to receive the delivery catheter 250, 280.

[0135] In one method of implanting 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 can be passed through the channel 172 of the suture mounting location 170 of the first tissue anchor 102 and tied to itself using a suitable knot. Preferably, the suture 106 extends from the second surface 176 of the anchoring portion 140 so that the suture 106 is located adjacent to the tissue of the mitral valve 114.

[0136] At block 402, the first tissue anchor 102 can be loaded onto the delivery catheter 250. For example, the suture 106 can be passed through the suture channel 270 of the first portion 260 of the tip 256 of the catheter 250. The suture 106 can be passed through the channel 270 in a direction from the tip 256 toward the 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.

[0137] 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 engaged with the tip 256.

[0138] At box 406, the first tissue anchor 102 is implanted at the first location 112. For example, the knob 266 can be used to rotate the drive rod 264, which rotates the second portion 262 of the tip 256 of the catheter 250. The rotation of the second portion 262, in turn, rotates the drive portion 142 and the anchor portion 140 of the first tissue anchor 102. The rotation of the anchor portion 140 spirals the first tissue anchor 102 into the tissue of the mitral valve 114 at the first location 112. Tension can be maintained on the suture 106 to inhibit or prevent rotation of the mounting portion 144 of the first tissue anchor 102, which can prevent the suture 106 from being entangled around the delivery catheter 250.

[0139] 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. The suture 106 may be removed from the tip 256 of the delivery catheter 250.

[0140] At block 410, the second tissue anchor 104 can be loaded onto the delivery catheter 250. For example, the suture 106 can be passed through the suture channel 172 of the second tissue anchor 104. The suture 106 can be passed through the suture channel 172 in a direction from the second surface 176 to the first surface 174 so that the suture 106 is located near the tissue of the mitral valve 114. The suture 106 can be passed through the suture channel 270 of the first portion 260 of the tip 256 of the catheter 250. The suture 106 can be passed through the channel 270 in a direction from the tip 256 toward the tube 252. The drive portion 142 of the second tissue anchor 104 can be inserted into the tool lumen 272 of the tip 256 of the catheter 250.

[0141] 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 using a suitable guiding technique to the second location 116. During delivery, the suture 106 may be tensioned to help maintain the second tissue anchor 102 engaged with the tip 256.

[0142] At box 414, the second tissue anchor 104 is implanted at the second location 116. For example, the knob 266 can be used to rotate the drive rod 264, which rotates the second portion 262 of the tip 256 of the catheter 250. The rotation of the second portion 262, in turn, rotates the drive portion 142 and the anchor portion 140 of the second tissue anchor 104. The rotation of the anchor portion 140 spirals the second tissue anchor 104 into the tissue of the mitral valve 114 at the second location 116. Tension can be maintained on the suture 106 to inhibit or prevent rotation of the mounting portion 144 of the second tissue anchor 104, which can prevent the suture 106 from being entangled around the delivery catheter 250.

[0143] 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. The suture 106 may be removed from the tip 256 of the delivery catheter 250.

[0144] At block 418, the suture lock 110 can be loaded onto the delivery catheter 280. For example, the suture 106 can be passed through the suture channel 226 of the base 180 of the suture lock 110. The suture 106 can be passed through the suture channel 226 in a direction from the end surface 230 to the shoulder surface 206. The suture 106 can be passed through the suture channel 290 of the tip 286 of the delivery catheter 280. The drive tool 298 can be inserted into the tool cavity 236 of the threaded fastener 186. The cap 182 can be inserted into the cavity 292 of the tip 286 of the delivery catheter 280.

[0145] At block 420, the suture lock 110 may be delivered to the second location 116 using the 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, the suture 106 may be tensioned to help maintain the suture lock 110 engaged with the tip 286.

[0146] At frame 422, the tension length 132 of the suture 106 can be adjusted. For example, the end surface 230 of the suture lock 110 can be positioned against the first surface 174 of the suture mounting portion 144 of the second tissue anchor 104. The suture 106 can be pulled and the column strength of the delivery catheter 280 can retain the second tissue anchor 104 and the suture lock 110 in place. Therefore, the suture 106 can be pulled through the respective suture channels 172, 226, 290 of the second tissue anchor 104, the suture lock 110, and the tip 286 of the catheter 280. As a result, the first tissue anchor 102 is pulled toward the second tissue anchor 104 and the tension length 132 is reduced. The suture 106 can also be released and the inherent elasticity of the tissue of the mitral valve 114 can increase the tension length 132.

[0147] At block 424, once the desired tensioning length 132 is reached, the stitch lock 100 can be locked to securely fix the suture 106 relative to the stitch lock 110. For example, the knob 300 can be used to rotate the drive rod 296. The rotation of the drive rod 296 rotates the drive tool 298, which rotates the threaded fastener 186 of the stitch lock 110. The rotation of the threaded fastener 186 causes the base 180 and the cap 182 of the stitch 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.

[0148] At box 430 , once the stitch lock 110 has been locked, but before the delivery catheter 280 has been removed from the stitch lock 110 , the performance or operation of the mitral valve 114 may be monitored by any suitable imaging procedure.

[0149] At box 426, the delivery catheter 280 can be withdrawn, leaving the suture lock 110 in place. For example, the catheter tip 286 and the drive tool 298 can be removed from the cap 182 and the threaded fastener 186, respectively, and the delivery catheter 280 can be withdrawn from the guide catheter 310.

[0150] At frame 428, the excess portion of the suture 106 can be trimmed. For example, the suture 106 can be passed through the suture channel 366 of the suture trimmer 350. The end of the suture trimmer 350 including the tip 356 can be inserted into the guide catheter 310 and advanced to the second position 116. The tip 356 slides along the suture 106 so that one end of the suture 106 remains outside the patient's body. The suture 106 can guide the tip 356 of the suture trimmer 350 to the suture lock 110. Once the tip 356 of the suture trimmer 350 is located adjacent to the suture lock 110, the control element 374 can be actuated to advance the cutting blade 364 within the slot 370 and cut the suture 106. The outer end of the suture 106 can be retained to maintain the tension of the excess portion of the suture 106, thereby allowing easier cutting.

[0151] As described above, the system 100 is configured such that the tensioning length 132 can be set, the operation of the mitral valve 114 monitored, and if necessary, the tensioning length 132 can be changed. This process can be repeated until the desired result is achieved.

[0152] Optionally, returning to box 430 , once the stitch lock 110 has been locked, but before the delivery catheter 280 has been removed from the stitch lock 100 , the performance or operation of the mitral valve 114 may be monitored by any suitable imaging procedure.

[0153] Optionally, at block 432, if adjustment is desired, the suture lock 110 can release the suture 106 to allow adjustment of the tension length 132. For example, the knob 300 can be used to rotate the drive rod 296 and the drive tool 298 in a counterclockwise direction (or opposite to the direction used to clamp the suture 106). The rotation of the drive tool 298 rotates the threaded fastener 186, which allows the cap 182 to move away from the base 180. As a result, the suture 106 is no longer clamped between the cap 182 and the base 180 and is allowed to move relative to the suture lock 110 and the second tissue anchor 104.

[0154] The tension length 132 may be adjusted as described above with respect to box 422. Once the desired tension length 132 is achieved, the suture 106 may be locked as described with respect to box 424. The method may then return to box 430 to allow for further monitoring and, if necessary, further adjustment. If the desired operation or performance of the mitral valve 114 has been achieved, the method may move to boxes 426 and 428 to release the suture lock 110 and trim the suture 106, as described above.

[0155] Tissue anchor covering

[0156] Figures 12A-12C An optional delivery catheter 250 is illustrated having a distal tip covering 500 located at the distal or delivery end of the catheter tube 252. The covering 500 can be configured to contain (e.g., cover) tissue anchors 102, 104 to inhibit or prevent the tissue anchors 102, 104 from damaging tissue (e.g., vasculature or cardiac tissue) prior to deployment. The covering 500 can be connected to (e.g., bonded or otherwise secured to) or surround the tip 256 of the catheter tube 252 at a connection 501. The covering 500 can be generally tubular in form and can define an interior space that receives the tissue anchors 102, 104. The covering 500 can have an open distal end through which the tissue anchors 102, 104 can be deployed.

[0157] The cover 500 includes a through hole in the form of a slot 502 that passes through the side wall of the cover 500 in a radial direction. The slot 502 accommodates the suture 106 so that the suture 106 can pass from the outside of the cover 500 to the inside of the cover 500. As described above, the suture 106 engages the tissue anchors 102, 104 that are initially located within the cover 500 prior to deployment. Thus, the suture 106 is located outside the catheter tube 252 and passes through the slot 502 to engage the tissue anchors 102, 104, as described above. Fig. 12B shown.

[0158] The covering 500 also includes a slit 504 that extends longitudinally from the slot 502 to the distal or free end of the covering 500. The slit 504 extends completely through the side wall of the covering 500. Thus, when the tissue anchors 102, 104 are deployed from the covering 500, the suture 106 can pass from the slot 502 through the slit 504, thereby allowing the suture 106 to be separated or detached from the covering 500 and the catheter 250. Fig. 12C Suture 106 is shown passing through slit 504 .

[0159] 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 covering 500 also allows for easy detachment of the suture 106 from the covering 500. The covering 500 can be constructed of any suitable material or combination of materials. For example, the covering 500 can be constructed of one or more suitable medical grade polymer materials. The covering 500 can be constructed of any suitable medical grade polymer materials. Figure 1-11 (For example Figure 1-11 The system 100 or components of the system 100 described herein may be implemented together with a delivery catheter 250. Optionally, Figures 12A-12C The catheter 250 can be connected with Figure 1-11 for use with system 100.

[0160] Unless expressly stated otherwise, or as otherwise understood from the context of use, conditional language used herein, such as "may," "likely," "may," "could," and "may" are generally intended to convey that some embodiments include, while other embodiments do not include, certain features, elements, and / or states. Thus, such conditional language is generally not intended to imply that one or more embodiments require a feature, element, and / or state in any way.

[0161] The term "plurality" refers to two or more of an item. The description of quantity, size, size, formulation, parameter, shape and other characteristics should be interpreted as if the term "about" or "approximately" precedes the quantity, size, size, formulation, parameter, shape or other characteristics. The term "about" or "approximately" means that the quantity, size, size, formulation, parameter, shape and other characteristics do not need to be precise, but can be approximate and / or larger or smaller as needed, which reflects acceptable tolerances, conversion factors, rounding, measurement errors, etc. and other factors known to those skilled in the art. The description of quantity, size, size, formulation, parameter, shape and other characteristics should also be interpreted as if the term "substantially" precedes the quantity, size, size, formulation, parameter, shape or other characteristics. The term "substantially" means that the listed characteristics, parameters or values ​​do not need to be precisely achieved, but rather that deviations or changes, including, for example, tolerances, measurement errors, measurement precision limitations and other factors known to those skilled in the art may appear in an amount that does not exclude the effect that the characteristic is intended to provide.

[0162] Numerical data can be expressed or presented in range format herein.It should be understood that this range format is used only for convenience and simplicity, and should therefore be flexibly interpreted as not only including the numerical values ​​explicitly listed as range limits, but also all individual numerical values ​​or sub-ranges included in the range, as if each numerical value and sub-range were explicitly stated.As an illustration, the numerical range of "1 to 5" should be interpreted as not only including the explicitly listed values ​​of about 1 to about 5, but also should be interpreted as also including the single value and sub-range within the indicated range.Therefore, the numerical range includes individual values, such as 2, 3 and 4, and sub-ranges, such as "1 to 3", "2 to 4" and "3 to 5" etc.The same principle applies to the range of only one numerical value (e.g., "greater than 1") and regardless of the breadth of the range or the characteristics described, it should be applicable.

[0163] For convenience, multiple items may be presented in a common enumeration. However, these enumerations should be interpreted as if each member of the enumeration were individually identified as a separate and unique member. Therefore, in the absence of contrary indications, no single member of such enumeration should be interpreted as being de facto equivalent to any other member of the same enumeration based solely on its presentation in a common group. In addition, when the terms "and" and "or" are used with enumerations of items, they should be interpreted broadly, because any one or more of the listed items can 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 those listed alternatives or only one listed alternative at a time, unless the context clearly indicates otherwise.

[0164] The present invention may also be broadly said to consist of any or all combinations of two or more of the parts, elements and features mentioned or indicated in the specification of the present application, either individually or collectively.

[0165] It should be noted that various changes and modifications to the currently preferred embodiments described herein will be apparent to those skilled in the art. Such changes and modifications may be made without departing from the spirit and scope of the present invention and without reducing the attendant advantages thereof. For example, various components may be repositioned as desired. Therefore, it is intended that these changes and modifications be included within the scope of the present invention. In addition, not all features, aspects, and advantages are necessary to practice the present invention. Therefore, the scope of the present invention is intended to be limited only by the appended claims.

Claims

1. A tissue anchor, comprising: an anchoring portion including helical threads configured to be implanted into body tissue by rotation about a longitudinal axis of the tissue anchor; a drive portion rotatably fixed relative to the anchor portion, the drive portion being configured to removably engage 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 rotatable relative to the anchoring portion and the actuation portion, the suture mounting portion configured to be coupled to a suture at a suture mounting location, wherein the suture mounting portion is configured to rotate to align the suture mounting location with a direction of force of the suture; Wherein the suture mounting portion is located between the driving portion and the anchoring portion along the longitudinal axis.

2. The tissue anchor of claim 1, wherein the helical thread of the anchoring portion is a helical coil defining a hollow interior space.

3. The tissue anchor of claim 2, wherein the helical coil comprises a circular cross-sectional shape. 4 . The tissue anchor of claim 1 , wherein the drive portion defines a radially outwardly facing drive surface configured to engage the drive member of the catheter.

5. The tissue anchor of claim 4, wherein the drive portion comprises a square cross-sectional shape defining the radially outwardly facing drive surface.

6. A tissue anchor according to claim 1, wherein the suture mounting portion has an outer peripheral surface surrounding the longitudinal axis of the tissue anchor, the outer peripheral surface defines a geometric center of the suture mounting portion, and wherein the rotation axis of the suture mounting portion is spaced apart from the geometric center.

7. The tissue anchor of claim 6, wherein the suture mounting location is located on an opposite side of the geometric center from the axis of rotation.

8. The tissue anchor of claim 1, wherein the suture mounting location comprises a channel extending through the suture mounting portion in a direction substantially aligned with a longitudinal axis of the tissue anchor.

9. The tissue anchor of claim 1, wherein a length of the anchoring portion along the longitudinal axis is greater than a length of one or both of the actuation portion and the suture mounting portion.

10. The tissue anchor of claim 9, wherein the length of the actuation portion is greater than the length of the suture mounting portion.

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