Suture lock and integrated delivery system

Abstract

The invention relates to a suture lock and an integrated delivery system. A suture lock for holding a tensioning suture in a tensioned state includes a housing having first and second through holes extending between a distal surface and a proximal surface, which are laterally separate, the housing having a side hole passing through and adjacent to the proximal surface, the side hole communicating with the first through hole; a trap within the first through-hole adapted to move longitudinally through the first through-hole, the trap having an opening; an anchor wire passing through a proximal portion of the first through hole through the side hole; wherein the suture lock has an open configuration in which the opening of the trap is at least partially outside the first through-hole, tensioning the suture through the opening of the suture and the second through-hole of the housing, freely translatable relative to the trap and the second through-hole of the housing, and a locked configuration in which the opening of the trap is within the first through-hole, the tensioning suture is held by the trap against translation in the tortuous configuration.

Description

[0001] This application is a divisional application of the invention patent application entitled "Device for placing and securing annuloplasty band", with an international application date of May 14, 2019, an international application number of PCT / US2019 / 032216, and a national application number of 201980047144.3. Technical Field

[0002] The present disclosure relates to devices and methods for delivering therapeutic devices in vivo, such as around the heart. In particular, devices for placing, tensioning, and locking therapeutic devices, such as annuloplasty bands, are disclosed. This invention was made in the performance of a cooperative research and development agreement with the National Institutes of Health, an agency of the Department of Health and Human Services. The U.S. Government has certain rights in this invention. Background Art

[0003] Devices for treating secondary tricuspid or mitral regurgitation have been proposed. As an example, a compression band delivered around the atrioventricular (AV) groove of the heart has been previously disclosed (see U.S. application serial number 62 / 580,033, the entirety of which is incorporated herein by reference). The compression applied to the heart by the band reduces the size of the stretched tricuspid and / or mitral annulus. In a particular example, the compression band includes a flexible mesh that can be shortened in length and, as it shortens, its cross-sectional diameter expands. This expansion distributes the compressive force more widely along the AV groove and minimizes the risk of obstructing flow through the coronary arteries or veins. The compression band is shortened using one or more tensioning sutures or threads passed through the central lumen of the band. When the suture(s) are pulled, the two ends of the band are brought toward each other. As greater tension is applied, the length of the band shortens and its diameter expands.

[0004] In certain embodiments, the suture(s) may be threaded through the locking device. During band tensioning, the suture(s) may be pulled or otherwise moved through the locking device. Once it has been determined that a satisfactory amount of tension has been applied, the locking device holds the suture(s) in its tensioned state or position. Thus, the band is maintained in its tensioned state, supplying compression to the heart in the AV groove.

[0005] Such locking devices may be difficult to use in cardiac environments and locations, particularly if the heart is approached in a minimally invasive manner (e.g., via venous and / or arterial access to the right atrial appendage). The locking device must be small, suitable for use in vivo for a substantial period of time, suitable for maintaining tension on the suture(s) as needed, and capable of remote placement and activation. In addition, minimally invasive devices for placing bands, for applying tension to the suture(s) and locking the sutures, and for making these items easily released may be desired. The following device embodiments meet the needs of locking the suture(s) in place, manipulating the tensioned suture(s), anchoring, setting and releasing the locking device, and releasing the tensioned suture(s) as may be desired. Summary of the invention

[0006] Embodiments of devices for minimally invasive surgery are shown, among other things, including providing tension on an implanted device. For example, an annuloplasty band for a heart may require tension to be applied thereto by an attached tensioning suture and maintained during the treatment procedure. Embodiments of tensioning devices, suture locks, and delivery devices are disclosed herein.

[0007] An embodiment of a tensioning device for applying tension on a tensioning suture such as one connected to an annuloplasty band may include a tubular outer member having a lumen and a distal opening of the lumen, the tubular outer member having an end surface surrounding the distal opening. A first wire having an end portion around which the tensioning suture is passed is within the lumen such that the end portion extends beyond the distal opening. A second wire has an end loop between two leg portions and is within the lumen such that at least a portion of the leg portions is within the lumen and the end loop is outside of the tubular outer member beyond the distal opening. In an extended configuration, the end portion of the first wire extends beyond the end loop of the second wire. The tensioning suture is one of: (a) passed under the end loop of the second wire and (b) passed through the end loop such that pulling the second wire engages the tensioning suture and pulls the tensioning suture. The first wire anchors the tensioning suture relative to the second wire during pulling. To prevent the tensioning suture from being pulled into the lumen, the diameter of the lumen may be equal to or slightly larger than the sum of the diameters of the portions of the first and second wires within the lumen.

[0008] In a particular embodiment, the lumen of the outer member has an inner diameter, and wherein the end collar is larger than the inner diameter of the lumen (the end collar has a maximum transverse dimension larger than the inner diameter of the lumen). The first wire may have a straight end portion that passes through the end collar of the second wire, and may include a bend in or near the end portion to prevent the first wire from being withdrawn prematurely. In an extended configuration in such cases, the tensioning suture passes around the end portion of the first wire between the end collar of the second wire and the end face of the tubular outer member. The first wire may be retracted relative to the second wire. In this retracted configuration, the end portion of the first wire does not extend through the end collar of the second wire, but is below the end collar so that the tensioning suture can come out from between the end collar and the end face of the tubular outer member. In other embodiments, the end portion of the first wire may have a looped end portion that connects at least one leg, and in an extended configuration, at least a portion of the end collar of the second wire is between the end face of the tubular outer member and at least a portion of the looped end portion of the first wire. The tensioning suture passes through the end loop of the second wire and passes around the at least one leg of the first wire below the looped end portion of the first wire. In this case, the first wire can be retracted relative to the second wire. In this retracted configuration, the looped end portion of the first wire can be retracted relative to the second wire so that the tensioning suture does not pass around the at least one leg of the first wire or the looped end portion.

[0009] An embodiment of a suture lock for holding a tensioning suture in a tensioned state may include a housing having a first through hole and a second through hole that are separated laterally and extend between a distal surface and a proximal surface. The housing may also have a side hole through the side surface and adjacent to the proximal surface, the side hole being connected to the first through hole. A snare having an opening is within the first through hole and is adapted to move longitudinally through the first through hole. In an embodiment having a side hole, an anchor wire may pass through a proximal portion of the first through hole and through the side hole. The suture lock has an open configuration, wherein the opening of the snare is at least partially outside the first through hole, and the tensioning suture passes through the opening of the suture and the second through hole of the housing. The suture can freely translate relative to the snare and the second through hole of the housing. In the locked configuration, the opening of the snare is within the first through hole, and the tensioning suture is held by the snare in a zigzag configuration to prevent translation.

[0010] In a particular example, the capture is a flat body and the opening is a middle eyelet that allows the tensioning suture to pass through. The capture may include an upper eyelet for attaching to a portion of the tensioning suture and a lower eyelet for accommodating a trigger wire. The trigger wire may include a ball fixed to the end of the wire, the ball fitting into the lower eyelet of the capture, so that pulling the trigger wire and the ball will pull the capture through the first through hole of the housing. An embodiment of the capture may have at least one tab connected to the proximal portion of the capture and extending from the proximal portion. In an open configuration, the at least one tab is bent toward the body of the capture through the wall of the first through hole of the housing and remains biased against the wall. In a locked configuration, the at least one tab exceeds the proximal surface of the housing and pivots outward from the capture so that the at least one tab prevents the capture from retracting into the first through hole. In such an example, the capture may include two lateral tabs, which, in an open configuration, are bent toward the body of the capture in the plane of the capture. Alternatively or additionally, at least one tab can extend out of the plane of the capture device so that in the open configuration, the at least one tab is bent toward the plane of the capture device, and in the locked configuration, the at least one tab is pivoted away from the plane of the capture device. Other examples of the capture device include a filament, and the opening is a loop in the filament. The housing can include an insert in the first through hole so that in the locked configuration, the tensioning suture engages the insert.

[0011] Embodiments of an integrated delivery system for an annuloplasty band may include: a delivery sheath; a pusher catheter within the delivery sheath and having an internal lumen; a suture lock (such as the embodiments described above) connected to a distal end of the pusher catheter; an annuloplasty band within the delivery sheath beside the pusher catheter and having a tensioning suture; and a tensioning device (such as the embodiments described above) for applying tension to the tensioning suture within the lumen of the pusher catheter and proximal to the suture lock. A first end or loop of the tensioning suture is secured to a portion of the suture lock, a middle portion of the tensioning suture passes through the suture lock, and a second end or loop of the tensioning suture is connected to the tensioning device.

[0012] In certain embodiments, the lumen of the pusher catheter includes a proximal portion having a first inner diameter and an end chamber having a second inner diameter larger than the first inner diameter. The suture lock can fit in the end chamber of the pusher catheter. The suture lock can include a proximal side hole, and the pusher catheter can include a side hole in the distal end, wherein the two sides remain at least overlapping. Safety and / or anchoring wires can extend through the side holes of the suture lock and the side holes of the pusher catheter to keep the suture lock and the pusher catheter together. A trigger wire can be connected to the suture lock, and the suture lock is moved to a locking configuration by the trigger wire to lock the tensioning suture in the suture lock. The trigger wire and the safety and / or anchoring wire can extend through the lumen of the pusher catheter.

[0013] Specific features of embodiments of the tensioner assembly may include any or all of the following. A tubular outer member or sleeve is used to allow bidirectional control of the end of the tensioning suture, i.e., the suture can be pushed and pulled. The ability to push the suture may be important because it allows the tension on the suture and around the annuloplasty band to be released without worrying about frictional resistance within the pusher and delivery sheath. The size of the inner diameter of the tubular member or sleeve is designed to prevent the tensioning suture from being pulled into the sleeve. If the release wire is in place, the retaining wire retains the end of the tensioning suture loop. The release wire or loop locks or anchors the tensioning suture in place relative to the retaining wire, but easily releases the suture when it is withdrawn from the retaining wire. Using a release wire in the shape of a loop prevents the withdrawal of the release wire without applying a threshold amount of tension to the release wire to cause the loop to collapse back into the sleeve. The rounded end of the release wire (whether a straight wire or a loop) makes it atraumatic or less likely to gouge the interior of other delivery system structures.

[0014] Specific features of embodiments of the suture lock assembly may include any or all of the following. The housing shape may fit or nest in the end of the pusher catheter. The locking suture uses a capture method, whereby the suture is pulled into the clamping point and a tortuous (e.g., S-shaped) arrangement is formed in the suture to lock the suture. The housing may have a conical surface or chamfer on the entry point of the capture and the suture, allowing the lock to be engaged on the capture with minimal pulling force or engaged on the housing with minimal pushing force. The housing may have a through hole (separated from the hole of the capture) for smoothly passing the tensioning suture through the lock and into the lumen of the pusher below. An embodiment of the capture may have an eyelet at the top of the capture for fixedly attaching one of the ends of the belt (e.g., via a portion of the tensioning suture), and an intermediate eyelet for passing the tensioning suture. These eyelets may be polished to provide a smooth edge to prevent cutting of the sutures passing through them. The bottom eyelet of the capture may limit a ball mounted to the end of the trigger wire, which can be released from the lock when the capture is pulled far enough into the housing. The catch may have a width expansion at its top to prevent the catch from sliding all the way through the housing. A set of one or more latch tabs may be provided on the catch that emerge from the bottom of the housing and widen as the catch is pulled downward. Such latch tabs are positioned so that they emerge from the bottom of the housing before the trigger ball can escape from the catch. Side holes in the housing may provide attachment points for anchoring the lock to the pusher guide tube and preventing the catch from prematurely passing downward through the housing and locking the lock's wire.

[0015] The delivery method may include one or more of the following steps in the order indicated or in another order that the user may prefer. The annuloplasty band is initially loaded onto a delivery frame that is initially loaded into a delivery sheath at a location distal to the suture lock and pusher catheter. The delivery sheath is pulled back to expose the frame, or the frame is extended from the delivery sheath, causing the frame and band to expand and encircle the heart. The band still loaded on the frame is tensioned by sliding the tensioner downward within the pusher catheter while the tensioning suture is held or locked to the tensioner by the tensioner. Once the excess band slack is tightened, the delivery frame is withdrawn alongside the pusher catheter. The tension on the band is adjusted by further positioning the tensioner (pulling or pushing the tensioning suture), such as by sliding the tensioner toward or away from the suture lock and annuloplasty band within the pusher catheter. With the appropriate tension set, the safety / anchor wire is pulled, which unlocks the lock trigger wire or otherwise allows its use, thereby enabling the lock to be locked. Pulling the safety / anchor wire also allows the suture lock to be released from the pusher catheter. The lock trigger wire is then pulled, causing the capture to move further into the housing and pull the tensioning suture to the locked position. Pulling the trigger wire latches the capture in place and allows the ball at the end of the trigger wire to escape. Alternatively, the lock trigger wire can be held in place and the pusher catheter advanced to push the lock housing forward while the capture remains in place, resulting in the same lock, latch, and trigger wire release. The release wire or loop is pulled from the tensioner, causing the tensioning suture to be released from the tensioner. The delivery sheath is withdrawn, leaving the band, tensioning suture, and lock in the body. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] Figure 1 is a perspective view of an embodiment of a tensioning device according to the present disclosure.

[0017] Figure 2 is a perspective view of an embodiment of a tensioning device according to the present disclosure.

[0018] Figure 3 is a perspective view of an embodiment of a suture lock device according to the present disclosure, with a tensioning suture in an open or unlocked state.

[0019] Figure 4 It is in locked state Figure 3 A perspective view of an embodiment of the present invention.

[0020] Figure 5 yes Figure 3 A partial cross-sectional view of an embodiment of the present invention.

[0021] Figure 6 yes Figure 4 A partial cross-sectional view of an embodiment of the present invention.

[0022] Figure 7 is from Figure 6 Observed from the left Figure 6 A partial cross-sectional view of an embodiment of the present invention.

[0023] Figure 8 yes Figure 3 A perspective view of an embodiment of a housing of an embodiment.

[0024] Fig. 9 yes Figure 8 A cross-sectional view of an embodiment of the present invention.

[0025] Fig.10 yes Figure 3 A perspective view of an embodiment of a capture device of an embodiment.

[0026] Fig.11 yes Fig.10 A side elevation view of an embodiment of the present invention.

[0027] Fig.12 It can be used with Figure 8 A perspective view of an embodiment of a capture device for use with an embodiment of a housing.

[0028] Fig.13 is a cross-sectional view of an embodiment of a suture lock device according to the present disclosure, wherein the tensioning suture is in an open or unlocked state.

[0029] Fig.14 is a partial cross-sectional view of an embodiment of an integrated delivery system for a medical device, shown in this embodiment as an annuloplasty band, and including the structures shown in the previous figures.

[0030] Fig.15 and Fig.16 yes Figure 3 A partial cross-sectional view of an embodiment showing the trigger and safety / anchor wire structures. DETAILED DESCRIPTION

[0031] Although the present disclosure may be embodied in many different forms, for the purpose of promoting an understanding of the principles of the present disclosure, reference will now be made to the embodiments shown in the accompanying drawings, and specific language will be used to describe the embodiments. However, it will be understood that it is not intended to limit the scope of the present disclosure thereby. It will generally be appreciated by those skilled in the art to which the present disclosure relates that any changes and further modifications in the described embodiments and any further applications of the principles of the present disclosure as described herein will be considered.

[0032] Turning now to the accompanying drawings, Figure 1 An embodiment of a tensioning device 20 for applying tension to a suture 22 is shown in FIG. The suture 22 is attached to a compression band ( Fig.14), the compression band is placed or is intended to be placed in or near the AV groove of the heart. In certain embodiments, when the band is so placed, pulling on suture 22 or otherwise applying tension to the suture results in (1) a compressive force on the band, which acts to compress the heart, and (2) a shortening of the length of the band and a simultaneous widening of the tubular band, which acts to protect veins, arteries, or other heart structures.

[0033] The device 20 can be placed in a minimally invasive manner, for example, through a sheath or catheter as described below, and connected to the suture 22. In a particular embodiment, the device 20 directly engages the suture 22, and can be so engaged before the compression band is placed around the heart. The device 20 includes a tube or sleeve 30, a first release and anchoring wire 32, and a second retaining wire 34. The tube 30 serves as a retainer and channel for the wires 32, 34, and has a lumen 36 through which the wires 32, 34 extend. In a particular embodiment, the tube 30 is made of a flexible material that can pass through a path through the vascular system without kinking. Exemplary materials include nitinol or stainless steel. The inner diameter of the tube 30 can be very small, for example, just large enough to accommodate the wires 32, 34, so as to prevent or limit the tensioning suture 22 from being pulled into the end of the tube 30. The end 38 of the tube 30 can have a rounded leading edge to minimize the risk of the end 38 gouging the interior of the components (such as the pusher catheter (discussed below)) through which the tensioner 20 moves. The wires 32, 34 may be biocompatible, such as Nitinol or stainless steel.

[0034] exist Figure 1 The wire 32 in the embodiment of the embodiment is a straight member having an opening 40 extending to the tube 30 and an end portion 42 passing through the opening. As used herein, "wire" indicates an elongated thin member having a stiffness sufficient to apply tension to the suture 22, as described herein. It can be made of metal or other substances having such properties. The entire or part 42 of the wire 32 can have a constant diameter. In the embodiment shown, the maximum width of the part 42 (or the entire wire 32) is substantially less than the width of the lumen 36 of the tube 30, for example, half the width of the lumen 36 or less. In the embodiment shown, the wire 32 is centrally positioned within the lumen 36 or at the opening 40 of the lumen 36 and serves as a central anchor or support for the suture 22.

[0035] In the illustrated embodiment, the wire 32 is straight throughout, including the end portion 42. Alternatively, the wire 32 can include a bend in the end portion 42 or lead out of the straight end portion 42. For example, a bend can be heat-set in a portion of the wire 32 as a boundary of the end portion 42, and the bend can be positioned beyond the end 38, i.e., exposed from the lumen 36. As described herein, in the initial configuration or when the tensioner 20 is in a mode suitable for tensioning the suture 22, the bend can position at least a portion of the end 42 above the end 38 of the tube 30. In this way, the bend and / or the end portion 42 help prevent premature or accidental retraction of the wire 32, as discussed further below. In certain examples, the bends may form planar angles in the wire 32, such as obtuse, right, or acute angles, but obtuse angles (e.g., greater than 135 degrees) may be preferred so that the wire 32 (or end portion 42) does not damage or interfere with the interior of the tube 30, other portions of the tensioner 20, and / or the delivery sheath or other components therein (as discussed further below). In other embodiments, more complex bends (or more than one bend) may be placed in the wire 32, such as a partial spiral (pigtail) or other curved shapes.

[0036] exist Figure 1 In the embodiment of the present invention, the wire 34 is a looped member. In a specific embodiment, the wire 34 has a collar 50 between two leg portions 52, 54. The collar 50 is shown as open in the illustrated embodiment, with a gap 56 between the leg portions 52, 54. In other embodiments, the collar 50 can be closed, wherein the leg portions 52, 54 are bonded to each other (e.g., welded or glued together) or wrapped or twisted together. The collar 50 in this embodiment extends out of the tube 30, that is, beyond the opening 40, and can have a maximum outer width measured between the outer surfaces of the opposite parts of the collar 50, which is greater than the inner diameter of the opening 40 or greater than the outer diameter of the tube 30 at or near the end face 38. In such embodiments, the size of the collar 50 prevents the collar 50 from being pulled into the tube 30 through the opening 40. As shown, the collar 50 can be in a plane that is inclined or perpendicular to the central axis of the wire 32 and / or the lumen 36. One or two of the leg portions 52, 54 extend into the lumen 36. Such leg portions 52 and / or 54 may extend through the entire tube 30 or may be operably connected to a control device (not shown).

[0037] In this embodiment of the device 20, a first or straight wire 32 extends centrally (or approximately so) within the lumen 36 of the tube 30. The wire 32 also extends through the loop 50 of the wire 34. That is, the loop 50 passes around at least a portion of the wire 32, and one or both leg portions 52, 54 extend into the lumen beside at least a portion of the wire 34. The tensioning suture 22, which is connected to the compression band at both ends, has a loop or bight 60 that engages the device 20. In the embodiment shown, the suture 22 extends around the wire 32 under the loop 50 of the wire 34 (i.e., between the loop 50 and the end 38 of the tube 30), and comes out again under the loop 50. As shown in FIG. Figure 1 As shown, loop 50 of wire 34 is generally passed around one side of wire 32, and loop 60 of suture 22 is generally passed around the other side of wire 32. Thus, suture 22 cannot be removed from device 20 unless (1) wire 32 is removed, or (2) suture 22 is cut or separated from the compression band.

[0038] In operation, as described above, the loop 60 of the tensioning suture 22 passes under and around the loop 50 of the wire 34 and is effectively locked to the device 20. A handle (not shown) is connected to the tube 30 and the wire 32, and in some embodiments, to the wire 34, so as to allow the user to advance and retract the tube 30, the wire 32, and / or the wire 34. To adjust the tension, the user operates the handle to control the position of the tube 30, the wire 32, and the wire 34 individually or in combination. For example, retracting at least the wire 34, preferably with the tube 30 and possibly the wire 32 as a unit will pull the suture 22 together with the wire 34. The loop 50 of the wire 34 engages with the loop 60 of the suture 22, and because the suture 22 is secured to the compression band and looped around the wire 32, the suture 22 is pulled together with the wire 34. The rigid nature of the tube 30 allows for bidirectional control of the position of the suture 22, i.e., the tube 30 (and / or the wires 32, 34) can pull and push the loop 60 and suture 22 ( Fig.14 ). That is, advancing the tube 30 allows the end 38, alone or in combination with the loop 50 of the wire 34, to engage the suture 22 and move it forward. For example, advancing the tube 30 can allow the loop 60 of the suture 22 to be clamped between the surface 38 of the tube 30 and the loop 50 of the wire 34, and when the tube 30 and the wire 34 move forward, the suture 22 also moves forward. If the suture 22 is already under tension, this tension can be reduced by advancing the tube 30 and / or the wire 34.

[0039] Once the appropriate amount of tension is applied to the suture 22 by retracting the wire 34 and / or the tube 30, the tension can be locked using a suture lock as described below or by another suitable locking mechanism. When locked, the suture 22 is released from the device 20 by pulling the wire 32 into or through the lumen 36 of the tube 30. In the embodiment where the wire 32 includes a bend as discussed above, the bend increases the resistance to withdrawal, thereby providing some protection against premature or accidental release. For example, the engagement between the end portion 42 and the end 38 and / or the wire 34 caused by the bend can provide a slight resistance that the pulling of the wire 32 must overcome. Pulling the wire 32 straightens it at or near the bend (e.g., reducing or eliminating the bend), and allows the wire 32 to move through or into the lumen 36 of the tube 30. In the embodiment where the wire 32 is operably connected to the handle (not shown), the operator operates the handle to retract the wire 32 while maintaining the position of the wire 34 and the tube 30. Once the leading end of wire 32 passes through loop 60 of suture 22 (and / or through loop 50 of wire 34 ), suture 22 is free to pass between loop 50 and tube 30 and is released from device 20 .

[0040] It will be appreciated that the device 20 can be a stand-alone device or a part of a stand-alone device, or can be a component of another device. For example, the structure and features discussed above with respect to the device 20 can be packaged within a delivery device for a compression band, such as the embodiments of an integrated placement device discussed below, having the device 20 behind the compression band and a locking mechanism for retaining the suture 22. Once the compression band and associated locking mechanism are delivered from the delivery device, operation of the device 20 to tension the suture 22 can occur.

[0041] In summary, the use of the tensioner 20 with its tube 30 allows for bidirectional control of the ends of the tensioned suture 22, i.e., the suture can be pushed and pulled. The ability to push the suture 22 can be important because it allows the release of tension around the annuloplasty band without concern for frictional resistance within the delivery device (e.g., the pusher catheter and / or delivery sheath discussed below). If the release trigger wire 32 is in place, the retaining trigger collar 50 retains the collar 60 of the tensioned suture 22. The release trigger wire 32 or trigger collar that locks the tensioned suture 22 in place easily releases the suture 22 when the wire 32 is pulled back or withdrawn. The ends of the release trigger wire 32 are rounded to make it atraumatic or less likely to gouge the interior of other delivery system structures (as discussed below). The release trigger can use a looped shape to prevent withdrawal without applying a threshold amount of tension to cause the collar to collapse back into the tube 30.

[0042] In a related embodiment, a tensioning device 20' is shown. In most respects, device 20' is identical to device 20. The primary difference is that the wire 32 of device 20 is replaced by a looped wire 32', such that device 20' has two looped wires 32' and 34'. In this embodiment, tube 30' is identical to tube 30, having a central lumen 36'. Wire 34' includes a loop 50', which in this embodiment may be in a plane parallel to the central axis of lumen 36'. In this embodiment of device 20', wire 32' (having loop 33' and leg portions 35' and 37') extends centrally (or substantially so) within lumen 36' of tube 30'. Wire 32' (or specifically, one or both leg portions 35', 37') may include one or more bends as described above with respect to wire 32, and in certain embodiments, the bend(s) may divert or bend loop 33' away from wire 34'. Wire 34' also extends into or through lumen 36' beside wire 32' so that loop 50' and loop 33' are adjacent to each other and generally parallel to each other. Tensioning suture 22' connected to the compression band has loop 60' engaged with device 20'. In the illustrated embodiment, suture 22' extends through loop 50' of wire 34', around the lower portion (and / or legs 35', 37') of loop 33' of wire 32', and back through loop 50'. As in Figure 2 As seen in the example of FIG. 2 , the diameter of loop 60 ′ of suture 22 ′ is smaller than the diameter or maximum width of loop 33 ′ of wire 32 ′. Thus, suture 22 ′ cannot be removed from device 20 ′ unless (1) wire 32 ′ is removed, or (2) suture 22 ′ is cut or separated from the compression band.

[0043] The operation of the embodiment of the device 20' is substantially the same as the illustrated embodiment of the device 20. At least the wire 32', and in the particular example the tube 30' and the combination of the wires 32' and 34' are retracted or advanced (e.g., by a handle not shown) to control the position of the loop 60' of the tensioned suture 22'. As discussed above, retracting the device 20' (or an appropriate portion thereof) pulls the suture 22' to place it in tension, and advancing the device 20' reduces the tension and / or repositions the suture 22'. When the operator is ready to release the suture 22', e.g., when the appropriate tension is applied and locked into the suture 22', the wire 32' is pulled through the loop 60' of the suture 22', thereby allowing the suture 22' to easily slide out through the loop 50' of the wire 34'.

[0044] The wire 32' is preferably heat set or otherwise configured so that the radius of curvature of its loop 33' is greater than the radius of curvature of the loop 50' holding the wire 34'. In this way, when assembling the device 20' itself or incorporating it into another device (e.g., a delivery system for a compression band as discussed above), it is more difficult for the wire 34' to be inadvertently pulled through the suture 22' or into the lumen 36'. Another advantage of using a looped wire 32' instead of a straight wire 32 is that the loop 33', which is the leading end or terminal end of the wire 32', is more atraumatic than the terminal end of a straight wire 32.

[0045] Lock concept

[0046] Now go to Figures 3 to 13 , shows an embodiment of a suture lock 80 that allows a suture 22 (e.g., as discussed herein) to be attached to a compression band ( Fig.14 ) ) slides freely through the suture lock in the unlocked state, but permanently restricts the movement of the suture 22 when locked. In the illustrated embodiment, the lock 80 includes two components: a housing member 82 and a catcher member 84. The catcher 84 is assembled into the housing 82 and can move within the housing, which will be discussed further below. The suture 22 passes through the catcher 84 and the housing 82 and is movable relative to both when the lock 80 is unlocked. The lock 80 is locked by moving the catcher 84 relative to the housing 82 so as to grasp or clamp the suture 22.

[0047] The illustrated embodiment of the housing 82 is rigid and generally cylindrical in shape with an external step 90 that changes the diameter of the housing 82 from a narrow region 92 to a wider region 94. The narrow region 92 allows the housing 82 to engage or fit into a pusher catheter ( Fig.14 ). The fit may be a tight fit that stabilizes the position of the lock 82 during delivery and provides countertraction when the suture 22 is pulled through the lock 80 during tensioning of the suture 22. The lock 80 also includes a first through hole 96 that accommodates the capture 84, and a second through hole 98 that provides a passage for a portion of the suture 22 through the housing 82. A small side hole 100 is provided in the housing 82, which serves as an anchor point for a safety line that anchors both the lock 80 and the compression band to the pusher catheter and thereby prevents premature activation of the lock 80.

[0048] The through hole 96 extends from the upper or distal surface 102 of the housing 82 to the lower or proximal surface 104. In the illustrated embodiment, the hole 96 is straight (i.e., linear) and is bounded by a wall 106. As a specific example, the hole 96 can have a central longitudinal axis that is perpendicular to both the upper surface 102 (end in the wider region 94) and the lower surface 104 (end in the narrow region 92) and parallel to the cylindrical side surfaces of the narrow region 92 and the wider region 94. In this embodiment, the hole 96 is oblong, having a first transverse dimension that is smaller than a second transverse dimension, the transverse dimensions being perpendicular to each other. In a specific example, the hole 96 is generally in the shape of a rounded rectangle, with opposing side flat surfaces and corner quarter cylindrical surfaces.

[0049] In the illustrated embodiment where the first and second transverse dimensions are constant, the wall 106 has a lower or proximal portion 106a. Adjacent to the upper surface 102, the hole 96 widens in both transverse dimensions in the illustrated embodiment and in a particular example has a conical wall portion or chamfer 106b that widens from the wall portion 106a within the housing 82 to a larger diameter at the upper surface 102. The widened portion 106b: limits or eliminates sharp corners, particularly 90 degree corners, which may damage the suture 22 or provide stress points on the suture; and provides easy access to the suture 22, as further described below. As will be further described below, the size of the transverse dimensions is designed to accommodate the capture device 84, and in particular embodiments, the larger transverse dimension can be twice the smaller transverse dimension.

[0050] The through hole 98 is an oblong hole in the illustrated embodiment, having a wall 110 having two flat or planar middle portions 110a and two end semi-cylindrical portions 110b. The smaller transverse dimension is measured between the planar portions 110a, and the larger transverse dimension is measured between the centers of the portions 110b. In a particular embodiment, the larger transverse dimension of the hole 98 is the same or approximately the same as the larger transverse dimension of the wall portion 106a of the hole 96. The smaller transverse dimension of the hole 98 may also be the same or approximately the same as the smaller transverse dimension of the hole 96. The hole 98 extends from the upper surface 102 to the lower surface 104. The hole 98 and its wall 110 are separated from the hole 96 and its wall 106 so that no part of the holes 96, 98 overlaps or intersects. In this embodiment, the hole 98 has a central longitudinal axis parallel to the central longitudinal axis of the hole 96 and perpendicular to the surfaces 102, 104. The hole 96 may have corners at the surfaces 102, 104, or may be beveled or otherwise processed to minimize the corners.

[0051] The hole 100 is in the narrow region 92 of the housing 82, adjacent to but not intersecting the lower surface 104. In the illustrated embodiment, the hole 100 has a cylindrical wall 112 and extends from the outer surface of the housing 82 to the hole 96. In the illustrated embodiment, the hole 100 has a central longitudinal axis that is perpendicular to the hole 96 and parallel to the surfaces 102, 104. The inner diameter of the hole 100 can be small, for example just large enough to pass a trigger wire or other control mechanism.

[0052] The catcher 84 has a thin planar body 120 in the illustrated embodiment, having first and second ends 122, 124 and a middle portion 126. Opposing planar surfaces 128, 130 extend through the ends 122, 124 and portion 126. The end 122 has a dome-shaped head 132 having rounded end corners 134 and being wider than the middle portion 126. In the illustrated embodiment, the head portion 132 meets the middle portion 126 on both sides at a sharp step or boss 136 having a surface 138 that is perpendicular to the middle portion 126 and generally facing the end 124. The head portion 132 includes an oblong or elliptical upper eyelet 140 and, in a particular embodiment, has upper and lower planar surfaces 142a, 142b between circular or cylindrical surfaces 144a, 144b. The eyelet 140 extends all the way through the head portion 132 , from the surface 128 to the surface 130 , through openings in each surface.

[0053] The middle portion 126 has two straight sides 146 extending from a respective boss 136 toward the end 124. A sharp step or boss 148 is embedded from each side 146. A middle eyelet 150 extends through the middle portion 126 through an opening in each surface 128, 130. In the illustrated embodiment, the eyelet 150 is in the shape of a rectangle (e.g., a square) with rounded corners. In a particular embodiment, the eyelet 150 is located closer to the boss 136 than to the boss 148, and in one example, the edge of the eyelet 150 closest to the end 124 is one-third to two-fifths of the way from the boss 136 to the boss 148. The lower eyelet 154 is at least partially in the middle portion 126. In the illustrated embodiment, the eyelet 154 is circular and extends all the way through the body 120 through the opening in the surfaces 128, 130. The eyelet 154 may intersect the plane of the boss 148 (see, for example, Fig.11 ).

[0054] The end portion 124 includes a tail portion 160 that includes tabs 162, 164. The tabs 162, 164 are generally L-shaped, each having a respective tip 166 extending from the body 120 and a respective leg 168 extending from the tip 166. In the illustrated embodiment, each leg 168 is linear and extends from the tip 166 away from (e.g., obliquely relative to) the central longitudinal axis of the body 120 and toward the end portion 122. As shown in the drawings (e.g., Figure 10 to Figure 11 ), each leg 168 defines a respective channel 170 between itself and the body 120. For example, such channels 170 may be parallel to their respective legs 168, with an outlet 172 between the legs 168 and the adjacent boss 148. In such an embodiment, the portion of the body 120 adjacent the legs 168 and the boss 148 is substantially V-shaped. Fig.11 As best seen in FIG. 1 , the eyelet 154 can be at least partially located within the V-shaped portion of the body 120, and one or both ends 166 can engage the body 102 at the apex of the V-shaped portion. The tabs 162, 164 can pivot toward and away from the central longitudinal axis of the body 120, for example, about the respective ends 166 or the points where the respective legs 168 meet their ends 166, as will be discussed further below.

[0055] In the illustrated embodiment, the body 120 is a linear plate in which the eyelets 140, 150, and 154 are cut and polished to smooth their respective edges and limit the possibility of damage to the suture 22. In certain embodiments, the tabs 162, 164 are formed by cuts into the body 120 that form the channel 170. In other embodiments, the body 120 can be formed by molding or other processes. As with the housing 82, the capture 84 can be made of a rigid biocompatible material such as stainless steel, titanium, a strong polymer, or a similar substance or compound.

[0056] The capture device 84 fits within the aperture 96 of the housing 82 and is movable from an open position in which at least a portion of the eyelet 140 and the eyelet 150 are exposed above the surface 102 of the housing 82 and a locked position in which the tabs 162, 164 extend from the surface 104 of the housing 82 and are locked relative to the surface. The respective widths of the various portions of the capture device 84 are selected to allow such movement and locking of the suture lock 80. In one example, the width W of the intermediate portion 126 of the body 120 is less than or equal to the inner diameter of the aperture 96 of the housing 82 (or the larger dimension between the opposing portions of the wall 106b). The tabs 162, 164 have a maximum width (e.g., adjacent the respective bosses 148) in an unstressed or unfolded state that is greater than the inner diameter of the aperture 96 of the housing 82 (or the larger dimension between the opposing portions of the wall 106b). The width of the head portion 132 of the body 120 is greater than the width of the portion 106 b of the aperture 96 , but may be equal to or less than the size of the chamfered or conical portion 106 a of the aperture 96 .

[0057] In certain embodiments, the bottom eyelet 154 of the catch 84 constrains or retains a ball mounted to the end of the trigger wire (see, e.g., Fig.14 222, 224 in the housing 82). A portion of the wire may pass along the through hole 96 of the housing 82 along with the catch 84. As the wire is pulled, the ball secured to its end forces the catch 84 further down into the hole 96. When the catch 84 has been sufficiently pulled through the housing 82, the ball passes through the bottom surface 104 of the housing 82. In a particular example, the ball passes through the bottom surface 104 at the same time or after the tabs 162, 164 pass through the surface 104 and expand to lock the catch 84 relative to the housing 82. Thus, the wire and ball can be removed from the suture lock 80 and withdrawn by the placement device. A separate wire (e.g., Fig.14 220 ) to retain or help retain the lock 80 to the delivery device and / or prevent the capture device 84 from passing down through the housing 82 prematurely.

[0058] Thus, the capture 84 has a top eyelet 140 for anchoring to the band, a second middle eyelet 150 that allows free passage of the tensioning suture 22 in the unlocked state but restricts the movement of the tensioning suture 22 in the locked state, and a bottom eyelet 154 for lock activation with the trigger wire. The width of the capture 84 increases slightly near its top to prevent the capture 84 from being pulled completely through the housing 82. At the bottom of the capture 84, there is a pair of tabs 162, 164 that extend wider than the capture body 126 and pop out to latch the capture 84 in place when the capture 84 is pulled to its lowest or most proximal position and the tabs 162, 164 extend below the bottom surface 104 of the housing 82. The top eyelet 140 and the middle eyelet 150 are preferably electropolished or mechanically polished to round the edges and allow the suture to pass smoothly without cutting or tearing the suture.

[0059] Tension suture path and lock activation

[0060] In use, a tensioning suture 22 is passed from an annuloplasty band to which it is attached through a central eyelet 150 of the capture device 84 and into the through hole 98 of the housing 82. The band is attached, for example, by the opposite ends of the suture 22 to an eyelet 140 in the head portion 132 of the capture device 84. The suture 22 extends through the entirety of the hole 98 and to or toward a tensioning device, such as the embodiments of the device 20 described above. In the unlocked state (e.g., Figure 3 to Figure 4 ), the capture 84 is positioned relative to the housing 82 so that the intermediate eyelet 150 avoids the surface 102 of the housing 82 (e.g., is completely above the surface). The suture 22 can freely and smoothly translate through the eyelet 150 and the through hole 98 so that the suture 22 can be placed in a tensioned state as described above. The tabs 162, 164 are located within the through hole 96 and are forced inwardly relative to the V-shaped portion of the body 120 by the inner wall 106 of the through hole 96. In that case, one or both channels 170 are partially or completely closed or narrowed from an unstressed state, and the tabs 162, 164 are biased against the inner wall 106 of the hole 96.

[0061] To put it in a locked state (e.g. Figures 5 to 7), the capture 84 is pulled or otherwise forced through the housing 82. In the illustrated embodiment, the capture 84 is forced at least to the extent that the edge of the middle eyelet 150 (e.g., the edge closest to the head portion 132) moves past the surface 104 of the housing 82 as the capture 84 pulls the tensioned suture 22 into the through hole 96, and the tabs 162, 164 move past the surface 104 of the housing 82. By pulling the suture 22 into the hole 96 (reaching or passing through the chamfered or conical portion 106a), the capture 84 and the housing 82 force it into a 180-degree bend, an S-shape, or a similar tortuous configuration. The suture 22 is thus clamped between the capture 84 (e.g., the edge of the eyelet 150 and / or the surfaces 128, 130 of the body 120) and the inner wall 106 of the hole 96. As discussed above, embodiments of the aperture 96 may include a chamfered or tapered portion 106a that allows for a smooth transition of the suture 22 from an unlocked state to a locked state (e.g., allowing the lock to engage with a capture with minimal pulling force and / or engage with a housing with minimal pushing force) and minimizes damage to the suture 22 during the locking process. As previously described, in the illustrated embodiment, the tabs 162, 164 move past the surface 104 of the housing 82 to reach the locked position. As the tabs 162, 164 pass through the surface 104, the inward force acting on the tabs 162, 164 through the inner wall 106 of the aperture 96 is released, and the tabs 162, 164 move outward and open or expand the channel 170. As shown in FIG. Figure 5 and Figure 7 As shown, the open tabs 162 , 164 extend above the surface 104 of the housing 82 , thereby preventing the catch 84 from retracting into the aperture 96 of the housing 82 and ensuring that the lock 80 remains locked.

[0062] Other embodiments of the locking device are contemplated. For example, a suture lock 80' has a housing 82, and a catch 84' that is similar or identical to the catch 84, differing primarily in at least one intermediate tab 162'. In this embodiment, the tab 162' is cut from or formed in the body 120', but is bent out of the plane of the body 120'. The tab 162' extends a distance away from the body 120' such that when the catch 84' is inserted into the hole 96 of the housing 82, it is at least partially forced inward by the inner wall 106 of the hole 96, thereby creating a bias in the tab 162'. Similar to the action of the catch 84, when the catch 84' moves sufficiently through the hole 96 to allow the tab 162' to exit from the housing 82 (i.e., when the tab 162' passes the surface 104 of the housing 82), the tab 162' pops out a distance sufficient to cause at least a portion of the tab 162' to abut the surface 104. Similar to the tabs 162 , 164 , this embodiment with the tab 162 ′ provides a latch that is retracted or restrained when within the housing 82 , but pops out after being exposed from the housing 82 to prevent the catch 84 ′ from moving back into the housing 82 .

[0063] The catch 84' includes a rectangular (e.g., square) middle eyelet 150' substantially as described with respect to the catch 84. In this embodiment, the upper eyelet 140' is circular, and the lowermost eyelet 178' is rectangular (e.g., square) and communicates with the slot 170' formed by the outward bending of the tab 162'. In the illustrated embodiment, another circular eyelet 154' is between the lowermost eyelet 178' and the middle eyelet 150'. This additional eyelet 154' can be used in the same manner and for the same purpose as the lower eyelet 154 of the catch 84.

[0064] exist Fig.13 In the illustrated embodiment of the suture lock 80", the capture 84" is not formed by a planar body or plate, but rather by a filament 180". The housing 82" includes a through hole 96", similar to the above-described hole 96, having a conical or chamfered portion 106a", and a constant size (e.g., a rectangle with constant cross-sectional dimensions, or a cylindrical) portion 106b". In this embodiment, the maximum width of the constant size portion (e.g., the diameter of the cylindrical portion) is less than twice the width of the suture 22. The filament 180" is doubled or otherwise formed into a loop 182". When the suture 22 passes through the loop 182" and then downwardly through the hole 98 of the housing 82" (which in this embodiment is the same as the hole 98 of the housing 82), the loop 182" of the capture 84" corresponds to the eyelet 150 of the capture 84.

[0065] The operation of this embodiment is similar to that of the lock 20 and the capture 84 in that the suture is tensioned by pulling the suture 22 via the loop 182". Pulling on the filament 180" causes the loop 182" to move into or further through the hole 96". The loop 182" pulls the bight in the suture 22 into the hole 96", thereby wedging the bight (whose diameter is twice the diameter of the suture 22) against the walls of the conical / chamfered portion 106a" (which can be the upper half of the hole 96") and / or the constant diameter portion 106b" of the through hole 96". The bight in the suture 22 is thereby pressed by the walls of the hole 96", thereby locking the suture 22 in the housing 82" in a tensioned state. In a particular embodiment, the housing 82" may include an insert or boss 184" within the hole 96" that acts as a catch for the loop of the suture 22. When the loop is pulled beyond the insert 184", the suture 22 is held not only by compression of the walls of the hole 96", but also by the edge(s) of the insert 184" resting against the sides of the loop in the suture 22. In another embodiment, no internal insert 184" is provided, but the loop of the suture 22 is pulled through an opening of the hole 96" in the lower surface 104" of the housing 82". The edge(s) of the opening provide friction or pressure to resist the ability of the loop of the suture 22 to pass back through the opening in the surface 104".

[0066] Integrated delivery components

[0067] An integrated delivery assembly 200 is also provided, an embodiment of which is Fig.14 In this embodiment, the delivery assembly 200 is designed to be operated within an access catheter or sheath, such as a pericardial access sheath 202, which serves as a conduit between the femoral vein access site and the pericardial cavity through a hole in the right atrial appendage. The embodiment shown includes a delivery band B (already in Fig.14 and a pusher catheter 206. Fig.14 , the heart is not shown for simplicity, but the band B will be delivered around the heart using the frame 204. As described above, an embodiment of the suture lock 80 is shown coupled to the pusher catheter 206, wherein the tensioning suture 22 is part of or attached to the band B and extends through the lock 80. An embodiment of the tensioner 20 is within the pusher catheter 206 and below the lock 80, and is connected to the suture 22, as discussed herein.

[0068] The sheath 202 can be part of the assembly 200 and introduced or placed when the band B is placed or other aspects of the assembly 200 are used, or the sheath 202 can be a separate component that is placed at a different time or for a different purpose and then used to pass the band B through other aspects of the assembly 200. As described, the sheath 202 can be a pericardial access sheath, at least with an inner diameter that allows the components of the assembly 200 to pass easily as a unit.

[0069] The pusher catheter 206 is a tubular member within the sheath 202 and has a lumen 210 that has a generally constant diameter in the illustrated embodiment but widens at a distal end 212. The distal end 212 includes a ledge or boss 214 that widens the lumen 210 from a mid-region to the end 212 to form a chamber 216 in the end 212 that is generally defined by the ledge 214 and sidewalls 218. The chamber 216 is sized to accommodate a portion of the suture lock 80, such as the lower narrowing or insertion portion 92 (e.g., Figure 3 ), thereby allowing the suture lock 80 to nest or be seated in the chamber 216. The pusher catheter 206 is preferably made of a material with good column strength that resists compression when a compressive force is applied. The preferred material is vinyl. The lock 80 can be fitted or squeezed into at least a portion of the chamber 216, for example, by the grip of the end 212 of the catheter 206 on the suture lock 80.

[0070] The illustrated embodiment of the catheter 206 includes a side hole 219 in the wall surrounding the chamber 216. When the suture lock 80 is placed in the catheter 206, the hole 219 is intended to be close to or adjacent to the side hole 100 of the housing 82 of the suture lock 80. The catheter 206 can be moved at least longitudinally within the sheath 202 to push the suture lock 80 and associated structures out of the sheath 202 and / or adjust the position of the suture lock 80 or other structures during placement or operation of the assembly 200. The catheter 206 can also be moved laterally and / or rotationally relative to the sheath 202, which may be necessary during use and / or this may be allowed by other structures within the sheath 202 (such as the frame 204).

[0071] The suture lock 80 includes a housing 82 and a capture 84 arranged in the illustrated embodiment as discussed above, but it should be understood that other embodiments or portions of the suture lock as disclosed herein may be used. The distal end of the capture 84 is secured or connected to the band B, for example, by tying the end of the suture 22 secured to one end of the band B to the capture 84. In a particular embodiment, the end of the suture 22 from one end of the band B can be looped around the head portion 132 of the capture 84 through the eyelet 140 and tied. The suture 22 passes through the band B. The suture 22 extends from the other end of the band B and passes through a second larger eyelet (e.g., the middle eyelet 150) in the capture 84, and enters and passes through the hole 98 through the housing 82, and enters the chamber 216 or another portion of the lumen 210 of the pusher catheter 206.

[0072] The tensioner assembly 20 is within the lumen 210 and proximal to the suture lock 80 , and the tensioner assembly may be or include any of the structures or embodiments discussed above. As previously described, the tensioner 20 is used to control the position of the free end of the tensioned suture 22 .

[0073] In this embodiment, the assembly 200 includes a pair of trigger wires 220, 222 that control the function of the suture lock 80. In certain embodiments, the wires 220, 222 are made of nitinol or stainless steel. The safety and anchoring trigger wire 220, shown extending through the lumen 210 on the left side of the pusher catheter 206, prevents the capture 84 from being pulled into the housing 82 and limits premature movement of the tensioned suture 22. It is also used to anchor the lock housing 82 to the pusher catheter 206. The wire 220 passes through the housing 82 of the suture lock 80, thereby entering the lower end of the hole 96 (wherein the capture 84 resides), and exits the housing 82 via the side hole 100. The wire 220 then passes through the side hole 219 of the pusher catheter 206, thereby effectively pinning the housing 82 of the suture lock 80 to the pusher catheter 206. In certain embodiments (e.g., Fig.16 ), the wire 220 can extend partially or completely around the outside of the catheter 206 and can be made of a strong shape memory material such as Nitinol. Because the wire 220 enters the through hole 96 for the capture 84, it prevents or limits the capture 84 from moving proximally through the hole 96 before the wire 220 is removed, thereby preventing the lock 80 from locking.

[0074] The locking trigger wire 222 is as described above in the context of the suture lock 80. In the illustrated embodiment, the wire 222 is just to the right of the safety and anchoring trigger wire 220. The wire 222 has a small ball 224 welded or otherwise secured to its distal end, and the ball 224 nests in the lower eyelet 154 in the capture 84. Figure 15 to Figure 16In the example of the embodiment of the present invention, the wire 222 includes a support or plate 226 having a hole 228 in which a ball 224 is fixed, and a groove 230 through which the safety wire 220 extends so as to prevent or limit the distal travel of the support 226 and the capture device 84. The ball 224 is fixed in the hole 228 so that when the suture lock 80 is assembled and unlocked, at least a portion (e.g., half or more) extends from the hole 228 into the eyelet 154. The ball 224 is preferably radiopaque or otherwise visible on a fluoroscopic or other imaging system so that the user can confirm the positioning and / or engagement of the suture lock 80 during surgery.

[0075] After the safety / anchor trigger wire 220 is pulled out (removed from holes 219 and 100 and out of the housing 82 of the suture lock 80 so that it does not block or restrict the capture 84 and / or support 226), the wire 222 is moved relative to the lock 80, such as by pulling on the wire 222 or by holding the wire 22 stable as the lock 80 is pushed forward by the catheter 206. The ball 224 nested in the capture 84 pulls the capture 84 (and the support 226, if any) through the hole 96 and deeper into the housing 82. In certain examples, the wire 222 can be partially manipulated (as described above) to pin the suture 22 to the housing 82 (e.g., against (one or more) surfaces 106a) without completely locking. The proximal portion of the suture 22 can be loosened (e.g., Figures 3 to 6 The filament 222 is then pulled further, thereby pulling this slack in the suture 22 into the housing 82 (e.g., into the lumen 96) to fully lock the suture. Providing this slack allows full locking to occur without over-tensioning the suture 22, thereby reducing or eliminating the risk of rupture of the suture 22. As discussed above, the capture 84 pulls the tensioned suture 22 into the housing 82 with it, thereby locking the suture 22 into the suture lock 80. The tabs 162, 164 (e.g., Figure 5 , Figure 7 ) pop out once they pass through the bottom surface 104 of the housing 82, thereby preventing the capture device 84 from returning distally through the hole 96 and releasing the suture 22.

[0076] As the capture 84 is pulled downward, the ball 224 is exposed below the housing 84 and out of the eyelet 154 of the capture 84. The ball 224 (and the support 226, if any) may eventually pass through the housing 82. With the ball 224 free from the capture 84 and the wire 220 previously removed, the suture lock 80 and the locked suture 22 may be released from the catheter 206. With the band B placed around the heart and the suture 22 appropriately tightened for treatment, the assembly 200 may be removed from the treatment site. Fluoroscopy or other imaging methods may be used during surgery to confirm the placement and engagement of the band B and / or suture lock 80.

[0077] In a particular method of using the assembly 200, the band B is first loaded onto the delivery frame 204. The frame 204 and band B are initially loaded into the delivery sheath 202 at a location distal to the pusher catheter 206 and the suture lock 80 disposed in the distal end of the pusher catheter 206. The frame 204 and band B are exposed from the delivery sheath 202, such as by moving the frame 204 out of the distal end of the delivery sheath 202 or by pulling the sheath 202 back relative to the frame 204. Once exposed, the frame 204 is expanded, and the user surrounds the heart with the frame 204 and annuloplasty band B.

[0078] In certain embodiments, band B is tensioned while still loaded on frame 204. As described above, tensioner 20 is slid proximally within pusher catheter 206 (e.g., Fig.14 , downward), while the tensioning suture 22 is locked to the tensioner 20 or otherwise held by the tensioner. For example, the tensioner 20 pulls the suture 22 through the hole 98 of the housing 82 and the eyelet 150 of the catch 84 of the suture lock 80. As desired by the user, tension is applied to configure the band B (to which the suture 22 is attached) to compress, for example, around and / or on a particular portion of the heart without damaging the vessel or other cardiac structures. Once the slack in band B is taken up, the delivery frame 204 is withdrawn from within band B and into the sheath 202 alongside the pusher catheter 206. The tension on the suture 22, and therefore band B, can be adjusted by further positioning of the tensioner 20. For example, sliding the tensioner 20 distally relative to the catheter 206 and the sheath 202 (as shown in FIG. 1 ) may be performed. Fig.14 206 and sheath 202 will increase the tension to tighten band B.

[0079] Once the appropriate tension for the desired treatment is established in the suture 22, the safety / anchor trigger wire 220 is pulled through the side hole 219 of the catheter 206 and the side hole 100 of the housing 82 so that the distal end of the wire 22 is within the lumen 210 of the catheter 206. When the wire 220 no longer prevents the capture 84 from moving further into the housing 82, the suture lock 80 can be set. The lock trigger wire 222 is pulled, thereby pulling the capture 84 further proximally into the housing 82. The capture 84 (and in the illustrated embodiment, the edge(s) of the eyelet 150) pulls the tensioned suture 22 into a locked position, such as into the hole 96 of the housing 82 to place the suture 22 in a zigzag configuration and / or wedge the suture 22 relative to the capture 84 and the wall(s) 106 of the hole 96 of the housing 82. As described above, tabs 162, 164 latch capture 84 in place and ball 224 at the distal end of wire 222 escapes from capture 84. As an alternative to pulling wire 222 to move capture 84 through housing 82, wire 222 may be moved relative to catheter 206 by holding it in place and advancing pusher catheter 206.

[0080] With band B placed, tension applied thereto via suture 22, and the tension locked via suture lock 80, tensioner 20 is released from suture 22. In the illustrated embodiment, the release line and / or loops 32, 33' (as discussed above) are pulled from tensioner 20. Suture 22 is thereby released from tensioner 20. Delivery sheath 202 and pusher catheter 206, frame 204, and / or tensioner 20 therein are withdrawn from the treatment site, leaving band B, tensioned suture 22, and suture lock 80 in the body. It will be appreciated that the components of assembly 200 may be withdrawn earlier after their use has been completed, rather than waiting for completion of all steps. For example, once frame 204 is withdrawn from band B as described above, it may be removed from delivery sheath 202 and the body at that time, rather than after suture 22 is released from tensioner 20.

[0081] The assembly 200 also provides a method for withdrawing the band B from the patient before locking and after the band B has been placed around the heart, for example, if there is an error, emergency, or other indication that the band B should be removed. In one example, once the decision to remove the band B has been made, the tensioning suture 22 is released from the tensioner 20, and the tensioner 20 can be withdrawn along or out of the pusher catheter 206 and / or delivery sheath 202. The suture lock 80 remains anchored to the pusher catheter 206 by the wire 222, and the ball 224 remains engaged to the catch 84 of the suture lock 80. That is, neither of the trigger wires 220, 222 is pulled from the suture lock 80. The delivery sheath 202, as well as the pusher catheter 206 and the suture lock 80 connected to the catheter 206, is then withdrawn, causing the tensioning suture 22 to release from the through hole 98 of the housing 82 and the eyelet 150 of the catch 84 of the suture lock 80. The connection between suture 22 and upper eyelet 140 of capture 84 is maintained so that retraction of suture lock 80 (and ball 224 and wire 222 keeping capture 84 attached to housing 82) pulls band B through assembly 200 around the heart and out of the body.

[0082] It will be appreciated that the features disclosed above can be connected directly or through an intermediate structure to an operating handle or system located outside the patient. Thus, the wires 32 and / or 34 of the tensioner 20, and in some embodiments, the tube 30 of the tensioner 20, can extend through the pusher catheter 206 and / or the delivery sheath 202 directly or via other structures to the handle, so that the wires 32, 34 and / or the tensioner 20 as a whole can be retracted or extended as desired by the operator. Similarly, the wires 220, 222 can extend through the pusher catheter 206 and / or the delivery sheath 202 (directly or via other structures) to the same or different handle, so that the wires 220, 222 can be appropriately retracted by the operator. Such a handle or separate item can be used to place the band B and withdraw the frame 204.

[0083] Although the present disclosure has been described and illustrated in detail in the drawings and the foregoing description, its features are considered to be illustrative rather than restrictive, and it should be understood that only selected embodiments have been shown and described, and it is desired to protect all equivalents, changes and modifications that fall within the spirit of the present disclosure as defined herein or in the appended claims. It will be understood that the features specifically described with respect to one or more specific structures or embodiments may be incorporated into other structures or embodiments disclosed herein or used in other ways with other structures or embodiments.

[0084] The following numbered clauses list specific embodiments that may be useful in understanding the present invention:

[0085] 1. A tensioning device for applying tension to a tensioning suture connected to an annuloplasty band, comprising:

[0086] a tubular outer member having a lumen and a distal opening of the lumen, the tubular outer member having an end surface surrounding the distal opening;

[0087] a first wire having an end portion around which the tensioning suture is passed, the first wire being within the lumen such that the end portion extends beyond the distal opening;

[0088] a second wire having an end collar between the two leg portions, the second wire being within the lumen such that at least a portion of the leg portions are within the lumen and the end collar is exterior to the tubular outer member beyond the distal opening;

[0089] wherein in an extended configuration, the end portion of the first wire extends beyond the end loop of the second wire, and wherein the tensioning suture one of: passes under and through the end loop of the second wire such that pulling the second wire engages the tensioning suture and pulls the tensioning suture, and wherein the first wire anchors the tensioning suture relative to the second wire during the pulling.

[0090] 2. The tensioning device of clause 1, wherein the lumen has an inner diameter, and wherein the end collar has a maximum transverse dimension that is greater than the inner diameter of the lumen.

[0091] 3. A tensioning device according to any one of clauses 1 or 2, wherein the first wire has a straight end portion and passes through the end collar of the second wire, and wherein in the extended configuration, the tensioning suture passes around the end portion of the first wire between the end collar of the second wire and the end face of the tubular outer member.

[0092] 4. A tensioning device according to clause 3, wherein the first wire is retractable relative to the second wire, and wherein in the retracted configuration, the end portion of the first wire does not extend through the end collar of the second wire, but is below the end collar so that the tensioning suture can exit between the end collar and the end surface of the tubular outer member.

[0093] 5. A tensioning device according to any one of clauses 1 to 4, wherein the end portion of the first wire includes a looped end portion joining at least one leg, and wherein in the extended configuration, at least a portion of the end loop of the second wire is between the end surface of the tubular outer member and at least a portion of the looped end portion of the first wire, and wherein the tensioning suture passes through the end loop of the second wire and around the at least one leg of the first wire under the looped end portion of the first wire.

[0094] 6. The tensioning device of clause 5, wherein the first wire is retractable relative to the second wire, and wherein in the retracted configuration, the looped end portion of the first wire is retracted relative to the second wire such that the tensioning suture does not bypass the at least one leg or the looped end portion of the first wire.

[0095] 7. A tensioning device according to any one of clauses 1 to 6, wherein the diameter of the lumen is equal to or slightly larger than the sum of the diameters of the portions of the first and second wires within the lumen, so that the tensioning suture is not pulled into the lumen.

[0096] 8. A suture lock for maintaining a tensioned suture in a tensioned state, comprising:

[0097] A housing having a first through hole and a second through hole extending between a distal surface and a proximal surface, wherein the first through hole and the second through hole are separated in a transverse direction, and the housing having a side hole passing through the side surface and adjacent to the proximal surface, wherein the side hole is in communication with the first through hole;

[0098] a catcher within the first through-hole and adapted to move longitudinally through the first through-hole, the catcher having an opening;

[0099] an anchoring wire passing through a proximal portion of the first through hole and through the side hole;

[0100] The suture lock has an open configuration and a locked configuration, wherein in the open configuration, the opening of the capture device is at least partially outside the first through hole, and the tensioning suture passes through the opening of the suture and the second through hole of the shell and is able to translate freely relative to the capture device and the second through hole of the shell, and in the locked configuration, the opening of the capture device is within the first through hole and the tensioning suture is held by the capture device in a zigzag configuration to prevent translation.

[0101] 9. The suture lock of clause 8, wherein the capture is a flat body and the opening is a central eyelet that allows the tensioning suture to pass through, the capture comprising an upper eyelet for attachment to a portion of the tensioning suture and a lower eyelet for receiving a trigger wire.

[0102] 10. The suture lock of clause 9, wherein the trigger wire includes a ball secured to an end of the trigger wire, the ball fitting into the lower eyelet of the capture device such that pulling the trigger wire and ball pulls the capture device through the first through hole of the housing.

[0103] 11. A suture lock according to any one of clauses 8 to 10, wherein the capture device includes at least one tab, the at least one tab being connected to a proximal portion of the capture device and extending from the proximal portion, such that in the open configuration, the at least one tab is bent toward the body of the capture device through the wall of the first through hole of the housing and is held biased against the wall, and in the locked configuration, the at least one tab extends beyond the proximal surface of the housing and pivots outwardly from the capture device, such that the at least one tab prevents the capture device from retracting into the first through hole.

[0104] 12. The suture lock of clause 11, wherein the capture includes two transverse tabs that, in the open configuration, are bent in the plane of the capture toward the body of the capture.

[0105] 13. The suture lock of clause 11, wherein the at least one tab extends out of the plane of the capture device such that in the open configuration, the at least one tab bends toward the plane of the capture device and in the locked configuration, the at least one tab pivots away from the plane of the capture device.

[0106] 14. The suture lock of any one of clauses 8 to 13, wherein the capture device comprises a filament and the opening is a loop in the filament.

[0107] 15. The suture lock of any one of clauses 8 to 13, wherein the housing comprises an insert in the first through hole, wherein in the locked configuration the tensioning suture engages the insert.

[0108] 16. An integrated delivery system for an annuloplasty band comprising:

[0109] delivery sheath;

[0110] a pusher catheter having an internal lumen within the delivery sheath;

[0111] a suture lock connected to the distal end of the pusher catheter;

[0112] an annuloplasty band having a tensioning suture within the delivery sheath alongside the pusher catheter; and

[0113] a tensioning device for applying tension to the tensioning suture within the lumen of the pusher catheter and proximal to the suture lock,

[0114] wherein a first end of the tensioning suture is fixed to a portion of the suture lock, a middle portion of the tensioning suture passes through the suture lock, and a second end of the tensioning suture is connected to the tensioning device.

[0115] 17. The system of clause 16, wherein the lumen of the pusher catheter comprises a proximal portion having a first inner diameter and an end chamber having a second inner diameter greater than the first inner diameter, and wherein the suture lock fits within the end chamber of the pusher catheter.

[0116] 18. A system according to any of clauses 16 or 17, wherein the suture lock is a suture lock according to claim 8.

[0117] 19. A system according to any of clauses 16 to 18, wherein the suture lock includes a proximal side hole and the pusher catheter includes a side hole in the distal end, wherein the side hole of the suture lock and the side hole of the pusher catheter at least overlap, and the system further includes a safety / anchor wire extending through the side hole of the suture lock and the side hole of the pusher catheter to hold the suture lock and the pusher catheter together.

[0118] 20. The system of clause 19, further comprising a trigger wire connected to the suture lock, wherein the tensioning suture is locked within the suture lock by the trigger wire, the trigger wire and the safety / anchor wire extending through the lumen of the pusher catheter.

Claims

1. A suture lock for maintaining a tensioned suture in a tensioned state, comprising: A housing having a first through hole and a second through hole extending between a distal surface and a proximal surface, wherein the first through hole and the second through hole are separated in a transverse direction, and the housing having a side hole passing through the side surface and adjacent to the proximal surface, wherein the side hole is in communication with the first through hole; a catcher within the first through-hole and adapted to move longitudinally through the first through-hole, the catcher having an opening; an anchoring wire passing through a proximal portion of the first through hole and through the side hole; The suture lock has an open configuration and a locked configuration, wherein in the open configuration, the opening of the capture device is at least partially outside the first through hole, and the tensioning suture passes through the opening of the suture and the second through hole of the shell and is able to translate freely relative to the capture device and the second through hole of the shell, and in the locked configuration, the opening of the capture device is within the first through hole and the tensioning suture is held by the capture device in a zigzag configuration to prevent translation.

2. The suture lock of claim 1 , wherein the capture is a flat body and the opening is a middle eyelet that allows the tensioning suture to pass through, the capture comprising an upper eyelet for attaching to a portion of the tensioning suture and a lower eyelet for accommodating a trigger wire.

3. The suture lock of claim 2, wherein the trigger wire includes a ball secured to an end of the trigger wire, the ball fitting into the lower eyelet of the capture device such that pulling the trigger wire and ball pulls the capture device through the first through hole of the housing.

4. A suture lock according to claim 2, wherein the capture device includes at least one tab, which is connected to a proximal portion of the capture device and extends from the proximal portion, so that in the open configuration, the at least one tab is bent toward the body of the capture device through the wall of the first through hole of the shell and is maintained biased against the wall, and in the locked configuration, the at least one tab extends beyond the proximal surface of the shell and pivots outward from the capture device, so that the at least one tab prevents the capture device from retracting into the first through hole.

5. The suture lock of claim 4, wherein the capture includes two lateral tabs that, in the open configuration, are bent in the plane of the capture toward the body of the capture.

6. A suture lock according to claim 4, wherein the at least one tab extends out of the plane of the capture device so that in the open configuration, the at least one tab bends toward the plane of the capture device, and in the locked configuration, the at least one tab pivots away from the plane of the capture device.

7. The suture lock of claim 1, wherein the capture comprises a filament and the opening is a loop in the filament.

8. The suture lock of claim 1, wherein the housing includes an insert in the first through hole, wherein in the locked configuration, the tensioned suture engages the insert.

9. An integrated delivery system for an annuloplasty band, comprising: delivery sheath; a pusher catheter having an internal lumen within the delivery sheath; a suture lock connected to the distal end of the pusher catheter; an annuloplasty band having a tensioning suture, the annuloplasty band being within the delivery sheath alongside the pusher catheter; as well as a tensioning device for applying tension to the tensioning suture within the lumen of the pusher catheter and proximal to the suture lock, wherein a first end of the tensioning suture is fixed to a portion of the suture lock, a middle portion of the tensioning suture passes through the suture lock, and a second end of the tensioning suture is connected to the tensioning device.

10. The system of claim 9 wherein the lumen of the pusher catheter comprises a proximal portion having a first inner diameter and an end chamber having a second inner diameter greater than the first inner diameter, and wherein the suture lock fits within the end chamber of the pusher catheter.

11. The system of claim 9, wherein the suture lock is the suture lock of claim 1.

12. The system of claim 9 wherein the suture lock comprises a proximal side hole and the pusher catheter comprises a side hole in the distal end, wherein the side hole of the suture lock and the side hole of the pusher catheter at least overlap, and wherein the system further comprises a safety / anchor wire extending through the side hole of the suture lock and the side hole of the pusher catheter to hold the suture lock and the pusher catheter together.

13. The system of claim 12, further comprising a trigger wire connected to the suture lock, by which the tensioning suture is locked within the suture lock, the trigger wire and the safety / anchor wire extending through the lumen of the pusher catheter.

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