Patent Description:
Referring first to <FIG>, the mitral valve <NUM> controls the flow of blood between the left atrium <NUM> and the left ventricle <NUM> of the human heart and, similarly, the tricuspid valve <NUM> controls the flow of blood between the right atrium and the right ventricle. For example, after the left atrium <NUM> receives oxygenated blood from the lungs via the pulmonary veins, the mitral valve <NUM> permits the flow of the oxygenated blood from the left atrium <NUM> into the left ventricle <NUM>. When the left ventricle <NUM> contracts, the oxygenated blood that was held in the left ventricle <NUM> is delivered through the aortic valve <NUM> and the aorta <NUM> to the rest of the body. Meanwhile, the mitral valve should close during ventricular contraction to prevent any blood from flowing back into the left atrium.

When the left ventricle contracts, the blood pressure in the left ventricle increases substantially, which serves to urge the mitral valve closed. Due to the large pressure differential between the left ventricle and the left atrium during this time, a large amount of pressure is placed on the mitral valve, leading to a possibility of prolapse, or eversion of the leaflets of the mitral valve back into the atrium. A series of chordae tendineae <NUM> therefore connect the leaflets of the mitral valve to papillary muscles located on the walls of the left ventricle, where both the chordae tendineae and the papillary muscles are tensioned during ventricular contraction to hold the leaflets in the closed position and to inhibit them from extending back towards the left atrium. This helps prevent backflow of oxygenated blood back into the left atrium. The chordae tendineae <NUM> are schematically illustrated in both the heart cross-section of <FIG> and the top view of the mitral valve of <FIG>.

A general shape of the mitral valve and its leaflets as viewed from the left atrium is shown in <FIG>. Commissures <NUM> are located at the ends of the mitral valve <NUM> where the anterior leaflet <NUM> and the posterior leaflet <NUM> come together. Various complications of the mitral valve can potentially cause physical problems, including fatal heart failure. One form of valvular heart disease is mitral valve leak or mitral regurgitation, characterized by abnormal leaking of blood from the left ventricle through the mitral valve back into the left atrium. This can be caused, for example, by dilation of the left ventricle and/or mitral valve annulus causing the native mitral leaflets not to coapt completely, resulting in a leak or regurgitation. This can also lead to problems with the native leaflets, and/or weakening of (or other problems with) the chordae tendineae and/or papillary muscles, which can in turn lead to mitral regurgitation. In these circumstances, it may be desirable to repair the mitral valve or to replace the functionality of the mitral valve with that of a prosthetic heart valve.

However, there has been limited research devoted to developing commercially available ways to replace a mitral valve through catheter implantation and/or other minimal or less invasive procedures, instead of via open-heart procedures. This may stem from mitral valve replacement being more difficult than aortic valve replacement in respects not accounted for by aortic valve replacement technology, for example, due to the non-circular physical structure of and more difficult access to the mitral annulus. Since transcatheter aortic valve technology is more developed, it could be beneficial to adapt similar circular valve prostheses for mitral applications.

A prominent obstacle for mitral valve replacement is effective anchoring or retention of the valve at the mitral position, due to the valve being subject to a large cyclic load. Especially during ventricular contraction, the movement of the heart and the load or pressure on the valve can combine to shift or dislodge an inadequately anchored prosthetic valve. In addition, the movement and rhythmic load can easily fatigue the implant, leading to fractures or other damage to the implant. Even a slight shift in the alignment of the valve may lead to the blood flow through the valve being negatively affected. Meanwhile, puncturing the tissue in or around the mitral valve annulus to better anchor the implanted valve can lead to unintended perforation of the heart and patient injury.

Another issue with mitral and tricuspid valve replacement is the size and shape of the native annulus. For example, a circular or cylindrical replacement valve similar to replacement aortic valves may not fit the mitral position. A replacement valve that is too small or the wrong shape may cause leaks around the implanted valve (i.e., paravalvular leak), if a good seal is not established around the valve. A replacement valve that is too large may stretch out and damage the native annulus. Furthermore, the presence of the chordae tendineae and other anatomy can form obstructions that make it more challenging to adequately anchor a device at the mitral position. Also, significant variations in anatomy of a mitral and/or tricuspid valve from patient to patient make it difficult to have a solution that will work for all or at least a wide variety of patients. <CIT> discloses various systems and devices associated with the placement of a dock or anchor for a prosthetic mitral valve. The anchor may take the form of a helical anchor having multiple coils.

The claimed invention is defined in independent claim <NUM> and relates to a delivery device for delivering an anchoring device to a native valve of a patient's heart. Some preferred configurations of the claimed invention are defined in dependent claims <NUM> to <NUM>. Also described herein are related aspects, examples, embodiments and arrangements useful for understanding the claimed invention, and which do not necessarily constitute embodiments of the claimed invention. The subject-matter for which protection is sought is defined by the claims.

Methods for treatment of the human or animal body by surgery or therapy practiced on the human or animal body, de jure excluded from patentability under Art. <NUM>(c) EPC, are not claimed and their description is left to facilitate understanding of the invention.

One way to apply circular or cylindrical transcatheter valve technology (e.g., as may be used with aortic valve replacement) to non-circular valve replacement (e.g., mitral valve replacement, tricuspid valve replacement, etc.) would be to use an anchor (e.g., a coiled anchor, helical anchor, mitral anchor, etc.) or docking device/docking station that forms or otherwise provides a more circular or cylindrical docking site at the native valve position (e.g., mitral valve position) to hold such prosthetic valves.

The anchoring or docking devices themselves can be designed for delivery via a transcatheter approach. One such anchoring or docking device is a coil or anchor that includes a helically shaped region that has a plurality of turns defining a circular or cylindrical inner space for docking the prosthesis or bioprosthesis, e.g., THV. In this manner, existing expandable transcatheter valves developed for the aortic position, or similar valves that have been slightly modified to more effectively replicate native valve function (e.g., native mitral valve function), could be more securely implanted in such a docking device/station positioned at the native valve annulus (e.g., native mitral annulus).

The docking device/station can first be positioned at the native valve annulus, and thereafter, the prosthesis (e.g., valve implant or transcatheter heart valve) can be advanced and positioned through the docking device/station while in a collapsed position, and can then be expanded, for example, via self-expansion (e.g., in the case of valves that are constructed with NiTi or another shape memory material), balloon expansion, or mechanical expansion, so that the frame of the prosthetic valve pushes radially against the docking device/station and/or tissue between the two to hold the valve in place.

Preferably, the docking device/station can also be delivered minimally or less invasively, for example, via the same or similar approaches (e.g., transcatheter approaches) as used for delivery of a prosthetic valve (e.g., a transcatheter heart valve), so that a completely separate procedure is not needed to implant the docking device/station prior to delivery of the prosthetic valve. Such docking devices can also potentially be used at any of the heart's native valves, for example, at the tricuspid, pulmonary, or aortic positions, to provide more secure implantation of prosthetic valves at those sites as well.

Deployment tools can be used to deliver these anchors or anchoring devices (e.g., coiled or helical anchoring devices) to an implant site prior to delivery of the THV, to provide a more stable foundation or support structure into or against which the THV can be expanded or otherwise implanted. For example, a guide sheath and/or delivery catheter can be advanced through a patient's vasculature, so that a distal end of the delivery catheter is positioned at or near the implant site. The anchor or docking device can then be advanced through and/or out of the delivery catheter and transitioned and/or adjusted to a desired shape and position at the implant site. Optionally, a shape of the distal region of the delivery catheter can also be bent, angled, or otherwise adjusted to facilitate easier or more proper positioning of the anchor or docking device at the implant site. A handle of the delivery catheter can be designed to allow a practitioner or other end user to easily control the shape and/or movements of the distal region of the delivery catheter.

An advancement tool or mechanism (e.g., a pusher tool) can be part of a system for delivering the anchoring or docking device and can be used to physically push or otherwise advance the anchoring or docking device through and/or out of the delivery catheter. Pusher tools or other pushing mechanisms that provide an easy and effective way to advance an anchoring device through a delivery catheter to an implant site are described. Optionally, the pusher tool can also facilitate retraction and/or retrieval of the helical anchor back into the delivery catheter, for example, to reposition or remove the anchoring/docking device.

Delivery devices and systems for delivering a coiled anchoring device to a native valve annulus of a patient's heart can include various features, including those described in various locations in this disclosure. The anchoring device can be configured to secure a prosthetic heart valve at the native valve annulus. The delivery devices and systems can include a delivery catheter having a longitudinal axis and a distal region configured or adjustable/transitionable to curve in a plane (e.g., in a plane that intersects the longitudinal axis).

The delivery devices and systems can also include a pusher tool. The pusher tool can have a pusher (e.g., comprising a pusher wire, pusher tube, etc.) connectable (indirectly or directly) to the delivery catheter on a side opposite the distal region of the delivery catheter. For example, the delivery catheter can include a handle or be attached/connected to a handle that is connected or connectable to the pusher tool and/or pusher. Optionally, the pusher tool and/or pusher does not need to connect directly or fixedly to the catheter handle or delivery catheter, but can merely have the pusher or pusher wire inserted therethrough.

The pusher tool includes a body and a pusher. The body is configured to be rotationally fixed relative to the delivery catheter. The pusher tool includes a control (e.g., knob, button, tab, input, etc.) connected to the body and the pusher (e.g., a pusher wire or tube). In one embodiment, the control is a knob rotatable relative to the body, and the pusher is connected to the knob. The pusher (e.g., pusher wire or pusher tube) is configured to extend through the body to the delivery catheter, and to move translationally and/or axially in the delivery catheter when the control is actuated (e.g., when the knob is rotated relative to the body) to move an anchoring device that is held in the delivery catheter.

Methods of delivering a docking device or anchoring device (e.g., a helical or coiled anchoring device) to a native valve of a patient's heart can include a variety of steps, including steps disclosed in various locations in this disclosure. For example, the methods can include obtaining and/or providing an anchoring device/docking device (e.g., a coiled or helical anchoring device), a delivery catheter, a guide sheath, a pusher tool and/or pusher, and/or various systems, devices, and/or other components. The anchoring device can be configured to secure a prosthetic heart valve at the native valve.

In one example, the methods include positioning a distal region of a delivery catheter in an atrium of the heart, adjusting or transitioning the delivery catheter to a first position and/or configuration where the distal region of the delivery catheter curves at least partially around the native valve and/or positioning a distal opening of the delivery catheter at or near a commissure of the native valve.

A pusher or pusher wire/tube is used to push all or part, such as a first portion (e.g., an encircling turn/coil and functional turns/coils), of the anchoring device out of the distal opening of the delivery catheter and into a ventricle of the heart. This can be done while holding the delivery catheter at the first position. The guide sheath, delivery catheter, pusher tool/pusher can be fixed or held in position at a proximal end by locking or securing the proximal end or a handle/body at the proximal end in a stabilizer (e.g., a stabilization device).

Where the pusher or pusher wire/tube includes a pusher tool having a knob (or other control) that can move and/or control the pusher or pusher wire/tube, the methods include rotating the knob (or otherwise actuating a control) of the pusher tool in a first direction to advance the pusher or pusher wire/tube distally through the delivery catheter while the delivery catheter is held at the first position. As the knob is rotated (or control is actuated) and the pusher or pusher wire/tube is advanced distally, the pusher or pusher wire/tube can push all or part, such as a first portion (e.g., an encircling turn/coil and functional turns/coils), of the anchoring device out of the distal opening of the delivery catheter and into the ventricle. This can include pushing the anchoring device through the commissure of the native valve, if the distal opening is positioned on the atrial side of the commissure.

Where the previous step only involves using the pusher or pusher tube/wire to push a first portion out of the distal end of the catheter (e.g., while the delivery catheter is held stationary), the methods then involve releasing a second portion (e.g., a stabilization coil/turn or atrial coil/turn) of the anchoring device from the delivery catheter. This can be done in a variety of ways. For example, the pusher tool, pusher, and/or pusher wire/tube can be locked or fixed in position (e.g., by locking or fixing a proximal end thereof, such as in a stabilizer, and/or by locking/holding/maintaining the knob in position), while the delivery catheter is pulled or retracted proximally. This can hold the anchoring device in position (e.g., because it abuts the stationary pusher or pusher wire/tube) while unsheathing it from the delivery catheter. If a guide sheath is used, the guide sheath can also be locked/fixed in position (e.g., in the stabilizer) while the delivery catheter is retracted.

Optionally, if the system is so configured, rotating a body of the pusher in a direction opposite to the first direction while holding a position of the knob (e.g., wherein the body of the pusher and the delivery catheter are rotationally fixed relative to one another such that the knob holds a position of the anchoring device at the native valve while the rotation of the body also rotates the distal region of the delivery catheter) causes proximal movement of the delivery catheter to release the second portion of the anchoring device from the distal opening of the delivery catheter into the atrium.

In one embodiment, delivery devices and systems for delivering an anchoring or docking device to a native valve annulus of a patient's heart comprise a delivery catheter and a pusher tool. The delivery catheter has at least one lumen (e.g., a first lumen) and can have multiple lumens, e.g., <NUM>-<NUM> lumens. The pusher tool comprises a pusher or pusher wire or tube. The pusher tool can also include a suture or line (e.g., a connecting or retrieval suture/line) and/or a suture or line lock or locking mechanism. The pusher tool can also include a rotatable member. The pusher or pusher wire or tube is slideably received within the first lumen. The pusher or pusher wire or tube has a distal portion and a proximal portion, and can have a lumen (e.g., a pusher lumen or second lumen) extending from the proximal portion to the distal portion.

The suture or line lock or locking mechanism can have any of the features/components described in various locations in this disclosure. For example, the suture/line lock or locking mechanism can be attached to the proximal portion of the pusher or pusher wire or tube. The suture or line (e.g., retrieval suture or line) can extend through the lumen (e.g., pusher lumen/second lumen) from the suture or line lock or locking mechanism to the docking device to connect the anchoring or docking device to the pusher tool.

The suture/line lock or locking mechanism can include a rotatable member connected to the suture or line (e.g., the retrieval suture or line). The rotatable member can be lockable in position in a variety of ways, for example, the rotatable member can have a first position (e.g., a locked or non-rotational position) that locks the amount of suture or line (e.g., the retrieval suture or line) that extends from the lock or locking mechanism and can have a second position (e.g., a movable or rotational position) that allows the amount of retrieval suture or line that extends from the lock or locking mechanism to be increased or decreased.

Methods of delivering an anchoring or docking device to a native valve of a patient's heart can include additional steps. For example, a distal region of a delivery catheter can be positioned in an atrium of the heart. The anchoring/docking device can be positioned or located within the delivery catheter. A pusher (e.g., a pusher wire or tube) of a pusher tool can be advanced distally through the delivery catheter, such that the pusher pushes and/or pulls the anchoring/docking device within and/or into or out of the delivery catheter (e.g., the pusher tool can be used to push the anchoring/docking device axially or distally within and/or out of the delivery catheter, and the pusher tool can be used to pull/retract the anchoring/docking device axially or proximally into and/or within the delivery catheter). The docking device can be connected to the pusher tool by a connector, e.g., a suture or line (e.g., optionally, using a suture/line lock or locking mechanism the same as or similar to those described in various locations in this disclosure). A member (e.g., a rotatable member) of the pusher tool can be rotated to change the amount of the suture extending from the pusher tool.

A replacement valve, for example, at the mitral or tricuspid position, can be held more securely through the use of a separate anchoring/docking device that provides a more stable docking site for the replacement valve. The anchoring/docking device is delivered through a delivery catheter, and a pusher tool or other pushing mechanism is used to provide easier control in advancing, retracting, positioning, and/or repositioning of the anchoring device at the implant site. The pusher tool can include a pusher, such as a pusher wire or pusher tube.

A pusher or pusher wire/pusher tube can be configured to extend through any of the delivery catheters disclosed herein. The pusher wire/tube can have a plurality of sections, and each of the plurality of sections can have a different stiffness. A first section of the of the pusher wire/tube can have a first stiffness, a second section of the pusher wire/tube can have a second stiffness, and a third section of the pusher wire/tube can have a third stiffness. The stiffness of the first section can be less than the stiffness of the second section, which can be less than the stiffness of the third section. The pusher wire/tube can be constructed of hypotube, polymer tube, coil pipe, coil spring, flexible tube, wire, rod, etc. One or more sections (e.g., the third section) of a pusher tube can be constructed of an uncut hypotube. One or more sections (e.g., the first section, second section, and/or third section) of a pusher tube can be constructed of a hypotube having interrupted cuts. The frequency and/or size of the interrupted cuts can change along the length of the hypotube. The pusher wire/tube can further include a cover (e.g., a polymer cover, fabric cover, etc.).

In one embodiment, the pusher tool includes a distal portion and a proximal portion, a lumen extending from the proximal portion to the distal portion, and an opening at the distal portion. A line or suture (e.g., a retrieval line/suture) extends through the lumen to connect the pusher tool to a proximal end of a docking device. The line/suture (e.g., retrieval line) can be threaded through a hole near the proximal end of the docking device thereby connecting the docking device to the pusher tool. The line/suture (e.g., retrieval line) can be threaded from the distal end of the pusher tool back through the central lumen to a proximal region of the pusher tool. First and second ends of the retrieval line can be connected to the proximal portion of the pusher tool. The pusher tool can further include a pusher or pusher wire/tube. The pusher or pusher wire/tube can have a distal end comprising a braided layer. The pusher tool can have a pusher or pusher wire/tube that includes a distal end having a soft layer. The pusher tool can further have a pusher or pusher wire/tube that includes a distal end having a rounded or curved tip region.

The pusher tool can further comprise a suture or line lock or locking mechanism, which can have any of the features/components described in various locations in this disclosure. In one embodiment, the lock or locking mechanism includes a body having a first portion, a second portion extending away from a central region of the first portion, and a rotatable member connected to and rotatable relative to the first portion of the body. The lock or locking mechanism can further include a handle at a first end of the body that extends from a side of the first portion of the body. The handle can facilitate turning the rotatable member relative to the first portion of the body. The lock or locking mechanism further includes an engagement feature at a second end of the body opposite the handle, wherein the engagement feature connects at least one end of the line/suture to the body. The lock or locking mechanism can further include a bore extending through the second portion of the body and connecting the first portion of the body with a distal opening of the body. The bore creates a pathway from the second portion of the body to the first portion of the body, wherein the pathway can allow the line to engage the rotatable member. The line/suture is anchorable using the engagement feature. Rotating the handle can be used to adjust an amount of the line that is wound around the rotatable member. The lock or locking mechanism can further include a window in the second portion that exposes a portion of the line. The lock or locking mechanism can further include a seal cap connected to the second portion of the body.

Further features and advantages of the invention will become apparent from the description of embodiments using the accompanying drawings. In the drawings:.

The following description and accompanying figures, which describe and show certain embodiments, are made to demonstrate, in a non-limiting manner, several possible configurations of systems, devices, apparatuses, components, methods, etc. that may be used for various aspects and features of the present disclosure. As one example, various systems, devices/apparatuses, components, methods, etc. are described herein that may relate to mitral valve procedures. However, specific examples provided are not intended to be limiting, e.g., the systems, devices/apparatuses, components, methods, etc. can be adapted for use in other valves beyond the mitral valve (e.g., in the tricuspid valve).

Disclosed herein are embodiments of deployment tools that are intended to facilitate implantation of prosthetic heart valves at one of the native mitral, aortic, tricuspid, or pulmonary valve regions of a human heart, as well as methods of using the same. The prosthetic valves can be expandable transcatheter heart valves ("THVs"). The deployment tools can be used to deploy anchoring or docking devices that provide a more stable docking site to secure prosthetic valve (e.g., THVs) at the native valve region. The deployment tools include a pusher tool or mechanism that facilitates easier and more accurate delivery and positioning of the anchoring device at the implant site, so that the anchoring devices and the THVs anchored thereto can function properly after implantation.

An example of an anchor/anchoring device/docking device is shown in <FIG>, though other configurations or variations are also possible. Anchoring or docking device <NUM> is a coil that is substantially helical or includes coils that are helical with a plurality of turns extending along a central axis of the docking device <NUM>, where the coil(s) can have various differently sized and shaped sections. The docking device <NUM> is configured to best fit at the mitral and tricuspid positions, but can be shaped similarly or modified in other embodiments for better accommodation at other native valve positions as well. <CIT> and <CIT> include additional examples and details of anchors/anchoring devices/docking devices that can be used with the systems, devices, apparatuses, methods, etc. in this disclosure.

The docking device <NUM> includes a central region/portion <NUM> with approximately three full coil turns having substantially equal inner diameters. The turns of the central region <NUM> provide the main landing or holding region for holding the THV upon implantation, and are therefore sometimes referred to as the functional coils of the anchoring device <NUM>, since the properties of these coils contribute most to the retention of the valve prosthesis relative to the docking device <NUM> and the native anatomy. A size of the coils of the central region <NUM> is generally selected to be slightly smaller than the outer diameter of the THV after expansion, to generate a sufficient radial forces or tension between the central region and the THV to fix them relative to one another and/or pinch native tissue (e.g., native leaflets and/or chordae) therebetween.

The docking device <NUM> is positionable in the native valve annulus (e.g., native mitral or tricuspid valve annulus) by rotating or cork-screwing a distal or leading tip (e.g., from the right or left atrium) through the native valve annulus (e.g., into the right or left ventricle). Since the size of the coils of the central region <NUM> is kept relatively small, the docking device <NUM> further includes a distal or lower region/portion <NUM> that forms a leading or encircling coil/turn (e.g., a leading ventricular coil) of the docking device <NUM>. The lower region <NUM> has a diameter that is greater than the diameter of the central region <NUM> so that the distal tip is positioned wider relative to the central axis of the docking device <NUM>, in order to more easily navigate the distal tip of the docking device around the features of the native anatomy, such as the chordae tendineae. When the distal tip is navigated around the desired anatomy, the remaining coils, which are smaller, can be guided around the same features, thereby encircling and corralling the anatomical features slightly inwardly. The lower region <NUM> can be kept relatively short to reduce flow disturbances.

The anchoring or docking device can optionally include a low-friction sleeve, e.g., a PTFE sleeve, that fits around all or a portion (e.g., the leading and/or functional turns) of the anchoring or docking device. For example, the low-friction sleeve can include a lumen in which the anchoring or docking device (or a portion thereof) fits. The low-friction sleeve can make it easier to slide and/or rotate the anchoring or docking device into position with less-friction and being less likely to cause abrasions or damage to the native tissue than the surface of the anchoring or docking device. The low-friction sleeve can be removable (e.g., by pulling proximally on the sleeve while holding a pusher and the docking device in place) after the anchoring or docking device is in position in the native valve, e.g., to expose the surface of the anchoring or docking device, which can be or include portions configured (porous, braided, large surface area, etc.) to promote tissue ingrowth.

The docking device <NUM> also includes an enlarged proximal or upper region <NUM> that makes up a stabilization coil (e.g., an atrial coil) of the docking device. The enlarged upper region <NUM> is sized and shaped to abut or push against the walls of native anatomy (e.g., the walls of a chamber of the heart or atrium), in order to improve the ability of the docking device <NUM> to stay in its desired position once it has been delivered to the implant site and prior to implantation of the THV. The docking device <NUM> can optionally also include a generally vertical extension <NUM> connecting the central region <NUM> and the upper region/portion <NUM>, and serving as a vertical spacer for spacing apart and forming a vertical gap between the upper region <NUM> and the other portions of the docking device <NUM>. In this manner, the amount of the docking device <NUM> that pushes against the native annulus can be reduced, thereby reducing stress on the native tissue. The docking device <NUM> can also have one or more through holes <NUM> at or near a free proximal end of the upper region <NUM>. The through holes <NUM> can serve, for example, as an attachment site for a delivery tool such as a pusher tool, pull wire, suture, etc..

Other embodiments of docking devices can have more or less turns in each of the described regions, or some regions (e.g., the enlarged upper region <NUM>) can be omitted altogether. In some cases, widths or thicknesses of the coil of the docking device can also be varied along the length of the docking device, based for example, on desired strengths and curvatures of certain coil regions. In some embodiments, additional layers, for example, a high friction cover layer, can also be added to the docking device to facilitate more effective delivery and/or implantation/retention. Meanwhile, while a direction of the turns of the docking device <NUM> are arranged for counter-clockwise advancement into the ventricle, the coils can optionally be wound in the opposite direction to facilitate clockwise advancement instead.

The docking device <NUM> is generally flexible, and can be made of or include, for example, a shape memory material, so that the coils of the docking device <NUM> can be straightened for delivery through a delivery catheter. For mitral applications, the docking device <NUM> can be delivered to the mitral position, for example, transatrially from the left atrium, transseptally through the atrial septum, or via one of various other known access points or procedures (e.g., transapically, etc.).

Various methods and steps can be used for delivering a docking device to a native heart valve. For example, <CIT> and <CIT> describe various methods and steps that can be used. Also, <FIG> show steps of an exemplary method that can be used for delivering a docking device <NUM> to the mitral position using a transseptal approach, where a delivery system/device <NUM> is advanced through the atrial septum of the heart. Referring first to <FIG>, the interatrial septum can be punctured, for example, at the fossa ovalis, and a larger guide sheath <NUM> of the delivery system/device <NUM>, which for example, houses and protects delivery catheter <NUM>, can first be advanced through the puncture hole and into the left atrium. In <FIG>, a distal region of a delivery catheter <NUM> is advanced out of a distal opening of the guide sheath <NUM> positioned in the left atrium in a substantially straight or unactuated configuration. In tricuspid procedures, it is generally unnecessary to puncture, cross, or advance through the septum.

Thereafter, when in a desired region or first chamber of the heart (e.g., right or left atrium), as shown in <FIG>, the distal region of the delivery catheter <NUM> itself can be bent or otherwise actuated to prepare for delivery of the docking device <NUM>. The distal region of the delivery catheter <NUM> can take various shapes based, for example, on the shape of the anchoring or docking device, the delivery site, and/or the patient's anatomy. For example, the delivery catheter <NUM> in <FIG> delivers the docking device <NUM> in a clockwise direction near the A1P1 commissure.

In one embodiment, for example, as shown in <FIG>, the distal region of the delivery catheter <NUM> includes a first substantially straight portion <NUM> extending from the guide sheath <NUM>, followed distally by a shallow curved portion <NUM> to bend the distal region of the delivery catheter <NUM> towards the mitral plane. The shallow curved portion <NUM> is followed by a circular portion <NUM> that curves in a counter-clockwise direction (or optionally a clockwise direction) around and substantially planar to the native annulus (e.g., mitral or tricuspid annulus) to provide a general delivery path for the docking device <NUM>. Distal to the circular portion <NUM> can further be a flexible end portion <NUM> that can be angled or pointed slightly downwards. The flexible end portion <NUM> can be used to point the distal opening of the delivery catheter <NUM> downwards towards and/or into a commissure, for example, commissure A3P3 of the mitral valve, to facilitate easier advancement of the docking device <NUM> into another or second chamber of the heart (e.g., the left ventricle or right ventricle). The distal opening can be positioned adjacent the commissure and the anchoring or docking device pushed out of the opening and through the commissure, or the distal opening can be positioned at or just past the commissure such that the anchoring or docking device is pushed out of the opening directly into the second chamber.

The delivery catheter <NUM> can include multiple control or pull wires (e.g., <NUM>-<NUM> pull wires) arranged and configured such that applying tension to the control/pull wires causes the distal region of the delivery catheter <NUM> to curve and/or shape as desired. In one embodiment, at least two control/pull wires run through a wall of the delivery catheter and terminate at different locations in the distal region such that each control/pull wire causes a different portion of the distal region to curve when tensioned or pulled. The wires can be pulled directly or have controls (e.g., handles, tabs, knobs, buttons, inputs, and/or other components) for imparting tension and/or relaxing tension of the control wires/pull wires.

Referring again to <FIG>, after the distal region of the delivery catheter <NUM> has been actuated to a delivery position, a first stage of coil delivery can be performed, where the docking device <NUM> is extruded or pushed out from a distal opening of the delivery catheter <NUM>, through the native valve (e.g., mitral or tricuspid valve, such as through a commissure of the valve), and into the second chamber or left ventricle. The distal end of the docking device <NUM> can then be rotated around to encircle at least some of the anatomy in the second chamber or ventricle (e.g., leaflets and/or chordae) to corral the anatomy within the coils of the docking device <NUM>. This advancement of the docking device <NUM> through and/or out of the delivery catheter <NUM> can be accomplished, for example, with a pusher tool <NUM> according to embodiments of the invention, as will be described in more detail below. During delivery, the docking device <NUM> can be held in the delivery catheter <NUM> in a straightened or relatively straight configuration for easier maneuverability through the delivery catheter <NUM>. Thereafter, as the docking device <NUM> exits the delivery catheter <NUM>, the docking device <NUM> can return to its original or shape-memory coiled or curved shape.

After a desired amount of the docking device <NUM> has been advanced into the second chamber of the heart (e.g., left or right ventricle), the rest of the docking device <NUM> can then be deployed or released into the first chamber of the heart (e.g., left or right atrium) during a second stage of coil delivery. <FIG> shows one method of releasing the upper portion or stabilization coil/turn (e.g., atrial portion) of the docking device <NUM> into the first chamber (e.g., left or right atrium). In <FIG>, the distal region of the delivery catheter <NUM> is pulled and/or rotated backwards, while the docking device <NUM> is held at substantially the same position and orientation, until the entire docking device <NUM> is released from the delivery catheter <NUM>. For example, when the docking device <NUM> is advanced clockwise out of the delivery catheter <NUM> as shown in <FIG>, the delivery catheter can thereafter be pulled (and/or rotated counter-clockwise), as shown in <FIG>, to release the upper portion or stabilization coil/turn (e.g., atrial portion) of the docking device <NUM> therefrom. The pusher tool <NUM> can be adjusted during this procedure to extrude and/or push out the anchoring or docking device <NUM> from the delivery catheter <NUM> and/or pull/retract the delivery catheter while a position of the docking device <NUM> relative to the native anatomy (e.g., mitral or tricuspid anatomy) is maintained. In this manner, a lower portion (e.g., ventricular position) of the docking device <NUM> does not have to be adjusted or readjusted during or after delivery of the upper portion (e.g., atrial portion) of the docking device <NUM>. Various other methods of releasing the upper portion of the docking device <NUM> can also be employed in other embodiments.

After the docking device <NUM> is fully deployed and adjusted to a desired position at the implant site, any connections between the pusher tool <NUM> and the docking device <NUM> (e.g., connection sutures) can be detached, and the delivery device <NUM> can be removed from the implant site. <FIG> shows a cross-sectional view of a portion of a patient's heart with the docking device <NUM> implanted at the mitral position and prior to delivery of the THV. The enlarged upper portion/region or stabilization turn/coil <NUM> of the docking device <NUM> pushes against the first chamber walls (e.g., atrial walls) to help temporarily hold the docking device <NUM> at a desired position. The THV is then advanced through and expanded in the docking device <NUM>. The THV can be advanced using the same or a different delivery catheter.

<FIG> shows a cross-sectional view of a portion of the heart with both the docking device <NUM> and a THV <NUM> finally implanted at the mitral position. Similar positioning can be accomplished in the tricuspid valve. Generally, the THV <NUM> will have an expandable frame structure <NUM> that houses a plurality of valve leaflets <NUM> (e.g., artificial and/or pericardial leaflets). The expandable frame structure <NUM> can, for example, be self-expanding, mechanically expandable, or balloon expandable. Upon expansion, radial pressures between the THV <NUM> and the docking device <NUM>, as well as with the surrounding anatomy, securely hold the entire assembly in place at the native valve position (e.g., mitral or tricuspid position).

As discussed above, <FIG> shows a perspective view of a distal section of the delivery catheter <NUM> in an exemplary actuated delivery state, but other actuated delivery states are possible. Control or actuation of the distal section of the delivery catheter <NUM> can be accomplished, for example, through various controls that are integrated into a handle that is connected to a proximal end of the delivery catheter <NUM>. <FIG> shows a perspective view of an embodiment of a catheter handle <NUM> connected to the delivery catheter <NUM>. The catheter handle <NUM> includes an elongated main body that is connected to the delivery catheter <NUM> at its distal end 420a. The main body of the catheter handle <NUM> provides a central lumen or tubular bore extending therethrough (not shown) that is connected to the delivery catheter <NUM>, to provide access to the delivery catheter <NUM> from a proximal end 420b of the catheter handle <NUM>.

The catheter handle <NUM> can further include two controls <NUM>, <NUM> configured to adjust the shape or otherwise actuate the distal region of the delivery catheter <NUM>, for example, to the configuration shown in <FIG> or another configuration with two regions/portions curved in different dimensions. A first control <NUM> can be arranged in the form of a knob that can rotate around the catheter handle <NUM> (e.g., coaxial with the handle), and can control, for example, an internal threaded member (not shown) that increases or decreases the tension in a first control wire or pull wire connected to a first region (e.g., a first distal region) of the delivery catheter <NUM>. The first control knob <NUM> (or optionally the second control knob <NUM>)) can be used to adjust the shallow curved portion <NUM> for aligning the first region of the delivery catheter <NUM> with the plane of the native valve annulus for example, the mitral plane. Meanwhile, a second control <NUM> can also be arranged in the form of a knob that can also rotate around the catheter handle <NUM> (e.g., coaxial with the handle). The second control knob <NUM> can control another internal threaded member (not shown) that increases or decreases the tension in a second control wire or pull wire that is connected to a second region (e.g., a second distal region or a region distal to or distally adj acent to the first region) of the delivery catheter <NUM>, for example, to bend the circular portion <NUM> around the native valve annulus. In this manner, the handle can independently control the degree of flexion or actuation in multiple dimensions (e.g., in each of the shallow curved portions <NUM> and the circular portion <NUM>), for more precise positioning and delivery of the docking device <NUM>. Additional control wires or pull wires are also possible as discussed previously, and these can be similar to those discussed here and can be controlled with additional controls or knobs similar to controls <NUM>, <NUM> or with the same controls.

The handle can, optionally, also include one or more indicators, such as indicators 422a, 424a, that respectively identify an amount of flexion or actuation of the delivery catheter <NUM> effected by each of the controls (e.g., by controls <NUM>, <NUM>). The indicators 422a, 424a, can each be, for example, a window that is integrated into the catheter handle <NUM>, with a level indicator and a key which identifies how much each control is actuating the delivery catheter <NUM>. In some embodiments, a position of an internal feature associated with the controls <NUM>, <NUM>, for example, the internal threaded members which translate axially relative to the catheter handle <NUM> when one of the controls <NUM>, <NUM> is turned, can also serve as a level indicator through the indicators 422a, 424a. In this manner, the delivery catheter <NUM> can be more precisely controlled or adjusted. In some embodiments, a third controller is also included to control the distal end portion <NUM>, or the control of the distal end portion <NUM> can be integrated into one of the existing controllers, for example, the second control <NUM>.

The catheter handle <NUM> can also include additional features. For example, in <FIG>, the catheter handle <NUM> includes a collet mechanism <NUM> that can lock, for example, a position of a pusher body, a pusher wire, or other component relative to the catheter handle <NUM>. In <FIG>, the proximal end 420b of the handle further includes a proximal seal and flushing port <NUM> to facilitate easy flushing of the handle, delivery catheter <NUM>, and/or other components of the delivery device <NUM>. In other embodiments, a handle for controlling the delivery catheter <NUM> can include any of various other features which can assist in facilitating more precise and/or better handling of the delivery catheter <NUM>.

While the above features of the catheter handle <NUM> facilitate the control of the distal region of the delivery catheter <NUM> in preparation for delivering the docking device <NUM>, another tool or mechanism can be used to physically advance and retract the docking device <NUM> through the delivery catheter <NUM> and/or maintain its position.

<FIG> shows a perspective view of an exemplary pusher tool <NUM>, and <FIG> shows a perspective and partial cross-sectional view of the pusher tool <NUM> of <FIG>. The pusher tool <NUM> in <FIG> and <FIG> is presented schematically, and it is to be understood that a pusher tool <NUM> can either be an entirely separate tool from the catheter handle described above with respect to <FIG>, or in some embodiments, can be integrally formed with or combined with other embodiments of catheter handles. For example, in some embodiments, the catheter handle <NUM> in <FIG> can be designed to have an integrated pusher mechanism with features similar to or the same as the pusher mechanism discussed below, so that a separate pusher tool is not needed.

Referring to <FIG> and <FIG>, an exemplary pusher tool <NUM> can include a handle body <NUM>, a knob <NUM>, and/or a pusher wire or tube <NUM>. While various features/components and arrangements are described as examples, all the described features/components and arrangements are not required. For example, one embodiment can have a handle body <NUM> and a knob <NUM> that can rotate relative to each other to cause translational or axial movement of these components relative to each other, while another embodiment may not have one or both of these features and/or these features may not be arranged for relative axial or translational movement. One embodiment can just have a knob that rotates a rotational member and a pusher wire/tube that can wrap/wind on or off the rotational member to extend or retract in the delivery catheter. The pusher tool could also have a body with a fixed relationship to the pusher wire/tube that does not involve rotation or winding. The pusher tool can be connectable or not connectable to the delivery catheter.

As shown in the illustrated example in <FIG>, the handle body <NUM> can have an elongated and generally cylindrical profile. A central bore <NUM> can extend from a proximal end of the handle body <NUM> towards a distal end of the handle body <NUM>. The central bore <NUM> can define a generally cylindrical space within the handle body <NUM>, into which a base <NUM> of the knob <NUM> can extend. The distal end of the central bore <NUM> can be closed, and can have a portion <NUM> that is also substantially cylindrical, with a reduced diameter compared to that of the rest of the central bore <NUM>. In addition, between the portion <NUM> and the other portions of the central bore <NUM>, an engagement feature <NUM>, such as a projection or a groove, can be formed at an inner wall of the handle body <NUM>. The portion <NUM> of the bore <NUM> and/or the engagement feature <NUM> can be utilized to help attach the handle body <NUM> with the knob <NUM>.

The handle body <NUM> can, optionally, also define a tunnel or pathway <NUM> that connects the central bore <NUM> with the distal end of the handle body <NUM>. The tunnel <NUM> can include a first region <NUM> that extends substantially tangentially from the cylindrical profile of the central bore <NUM> (see, e.g., <FIG>), and can include a second region <NUM> that turns from the first region <NUM> towards the distal end of the handle body <NUM>, to provide a pathway for the pusher or pusher wire <NUM> to run from the central bore <NUM> to the distal end of the handle body <NUM>. As can also be seen in <FIG>, in some embodiments, an inner wall of the handle body <NUM> can also include a guiding key <NUM>, which can be a small projection, to guide the movement of the knob <NUM> relative to the handle body <NUM>. Meanwhile, at the distal end of the handle body <NUM>, a bore, luer, or other structural feature <NUM> can be provided for attaching and fixing the handle body <NUM> to other parts of the delivery device <NUM>, for example, to a delivery catheter <NUM> or a catheter handle <NUM>. In some embodiments, the body of the handle shell <NUM> is a monolithic piece, while in other embodiments, the handle body <NUM> can be multiple pieces, for example, two halves that can be assembled together.

Meanwhile, the knob <NUM> of the pusher or pusher tool <NUM> can include a base <NUM>, an enlarged head region <NUM> at one end for easier handling and rotating by a practitioner or other end user, and a knob support <NUM> at an opposite end for connecting the knob <NUM> to the handle body <NUM>. The base <NUM> of the knob <NUM> can be substantially cylindrical and sized for insertion into the central bore <NUM> of the handle body <NUM>. A diameter of the base <NUM> can be slightly smaller than a diameter of the central bore <NUM>, so that the base <NUM> fits snugly in, and can still turn or rotate while positioned in, the central bore <NUM>.

Near a distal end of the base <NUM> of the knob <NUM>, a slot or canal <NUM> can be formed in an exterior surface of the base <NUM> and can extend multiple times around the exterior surface of the base <NUM> in a spiraling or helical manner. The slot <NUM> can be sufficiently sized to hold the pusher or pusher wire <NUM> therein, so that the pusher wire <NUM> also wraps around the base <NUM> of the knob <NUM> in a spiraling or helical manner while held in the slot <NUM>. In some cases, the spiraling shape the pusher wire <NUM> is held in is similar to a shape and size of the docking device <NUM> (e.g., of a portion of the docking device <NUM>) when the docking device <NUM> is deployed, which can facilitate easier shaping of the pusher wire <NUM> through the curved distal portions of the delivery catheter <NUM> during delivery of the docking device <NUM>. Furthermore, when the handle body <NUM> and the knob <NUM> are connected, the slot <NUM> can be positioned fully within the central bore <NUM> of the handle body <NUM>. Therefore, due to a snug fit between the central bore <NUM> of the handle body <NUM> and the base <NUM> of the knob <NUM>, the slot <NUM> can be substantially enclosed by the handle body <NUM> and the knob <NUM>, so that portions of the pusher wire <NUM> that are held in the slot <NUM> are entirely supported in all radial directions around a central axis of the pusher tool <NUM>, preventing the pusher wire <NUM> from spreading out of or otherwise escaping the slot <NUM> of the knob <NUM>, and ensuring proper functionality of the pusher tool <NUM>.

Meanwhile, as can best be seen in <FIG>, a plurality of ribs <NUM> can be formed in the knob <NUM> that extend transversely into the slot <NUM>. In the embodiment shown, the ribs <NUM> are arranged in pairs that extend from opposite sides of the slot <NUM> towards one another, and a plurality of such pairs of ribs <NUM> are positioned at intervals along at least part of the length of the slot <NUM>. In other embodiments, other rib arrangements can be formed in the slot <NUM>, so long as the pusher wire <NUM> can extend through the slot <NUM> past each of the ribs <NUM>. The ribs <NUM> increase a friction or abutting force between the pusher wire <NUM> and the knob <NUM>, which results in a higher pushing ability or force that the pusher wire <NUM> can impart on the docking device <NUM>, when compared for example, to a pusher tool where the only push force or abutting force is applied at a proximal end of the pusher wire by the pusher tool.

At one end of the base <NUM>, the knob <NUM> can have an enlarged head region <NUM>. The enlarged head region <NUM> can be adapted for easy handling and rotation by a practitioner or other end user. In the embodiment shown, the enlarged head region <NUM> is also cylindrical, with a diameter that is greater than a diameter of the base <NUM>, and includes a plurality of longitudinal ribs or gripping features for improved grip. The enlarged head region <NUM>, in other embodiments, can be designed with different shapes and sizes, so long as safe and easy handling and manipulation of the knob <NUM> relative to the handle body <NUM> can be achieved.

Referring back to <FIG>, the knob support <NUM> shown is a cylindrical or tubular piece that extends away from the base <NUM> of the knob <NUM> on a side opposite the enlarged head region <NUM>, with a diameter that is less than the diameter of the base <NUM>. The knob support <NUM> can connect the knob <NUM> to the handle body <NUM>. For example, the knob support <NUM> can be sized to fit inside the smaller distal portion <NUM> of the central bore <NUM> of the handle body <NUM>, and can have a circumferentially extending groove <NUM> that is configured to engage the projecting engagement feature <NUM> of the handle body <NUM>, to prevent the knob support <NUM>, as well as the rest of the knob <NUM>, from falling out or disconnecting from the handle body <NUM>. In some embodiments, the locations of the groove and projection can be switched, or other engagement features can be utilized, so long as the knob <NUM> can freely turn relative to the handle body <NUM>. The knob support <NUM> can be axially movable relative to the rest of the knob <NUM>, so that the knob <NUM> can still move axially relative to the handle body <NUM> in order to maintain alignment of the respective pathways for the pusher wire <NUM>. The knob support <NUM> can extend, for example, into a bore formed at a distal end of the base <NUM> of the knob <NUM>, and an additional engagement feature (not shown) holds the knob support <NUM> and the rest of the knob <NUM> together. In one embodiment, the knob support <NUM> is formed monolithically with the rest of the knob <NUM>, where the engagement between the knob support <NUM> and the handle body <NUM> can be modified to allow the knob support <NUM> to also move axially relative to the handle body <NUM>.

The pusher or pusher wire <NUM> can connect the docking device <NUM> to the rest of the pusher tool <NUM>, and can be the part or one of the parts that physically pushes or otherwise deploys, and in some embodiments, pulls or otherwise retrieves, the docking device <NUM> relative to the delivery catheter <NUM>. As can be seen most clearly in <FIG>, the exemplary pusher wire <NUM> in the figure is shown as being constructed as a spring wire formed by a compact and fully contracted spring. Respective diameters of the physical wire that forms the spring, as well as of the structure of the pusher wire <NUM> as a whole, can be selected to give the pusher wire <NUM> enough flexibility to wrap around and turn together with the knob <NUM>, and with enough stiffness to push and/or resist retraction of the docking device <NUM> during deployment of the docking device <NUM>, while avoiding portions of the pusher wire <NUM> collapsing longitudinally inside either the tunnel <NUM> of the handle body <NUM> or the slot <NUM> of the knob <NUM>. In embodiments where the pusher wire <NUM> is constructed as a spring wire, the surface of the pusher wire <NUM> can also provide additional engagement features that interact with the ribs <NUM> in the slot <NUM>, which can further enhance the pushing force of the pusher tool <NUM>.

Optionally, pushers or pusher wires/tubes can be constructed in any of various different manners. For example, the pusher or pusher wire/tube can be constructed with or include a polymer tube, can be a laser cut hypotube with a polymer cover, can be a coil pipe or spring, or can be constructed with or include any other form of flexible tube, so long as axial pressures can be applied against the pusher or pusher wire/tube with minimal or no axial compression, so that the pushing of the docking device <NUM> is not compromised by the construction of the pusher or pusher wire <NUM>.

In one embodiment, illustrated in <FIG>, an exemplary pusher or pusher tube/wire <NUM>' is constructed using a hypotube that is laser cut or otherwise cut to provide for multiple sections (e.g., three sections) with different flexibility. The pusher <NUM>' illustrated by <FIG> can be used separately from the pusher tool <NUM> illustrated by <FIG>. A first section <NUM>' can be formed with an uncut hypotube, so that the first section <NUM>' forms a stiffest portion of the pusher or pusher tube <NUM>'. A second section <NUM>' adjacent to the first section <NUM>' can be formed by cutting a hypotube with an interrupted cut, and the interrupted cut can, optionally, have axial intervals that decrease in a direction from the first section <NUM>' towards a third section <NUM>'. In this manner, the second section <NUM>' is stiffer in a region closer to the first section <NUM>', where the intervals between the cuts are larger, and more flexible towards the third section <NUM>', where the intervals between the cuts are smaller. Lastly, the third section <NUM>' can be formed by cutting the hypotube with an interrupted cut (e.g., an interrupted cut that stays constant at a small interval), so that the third section <NUM>' is the most flexible of the three sections of the pusher or pusher tube <NUM>'. In this or a similar manner, a pusher or pusher tube <NUM>' can be customized so that some portions provide for stronger support, while other portions allow for more flexibility, for example, portions of the pusher <NUM>' near the distal tip which maneuver through the distal turns of the delivery catheter <NUM>. In other embodiments, different flexible sections can be formed in various different manners. In some embodiments, a small portion near the distal end of the pusher <NUM>' can be left uncut, to impart extra strength to the distal tip <NUM>' of the pusher <NUM>'.

Referring now to <FIG>, a pusher or pusher wire/tube <NUM> has a distal end <NUM> that is constructed in an atraumatic manner. Either the pusher/pusher wire <NUM> discussed with respect to <FIG> or the pusher/pusher tube <NUM>' discussed with respect to <FIG>, or any other pusher or pusher wire/tube, can employ a distal end <NUM> similar to or the same as that shown in <FIG>. An atraumatic tip portion can be formed, for example, by adding an additional braided or other comparatively soft layer <NUM> to the distal end <NUM>, and/or by forming a rounded or otherwise more curved tip region, to prevent damage to the docking device <NUM>, any connecting sutures, the delivery catheter <NUM>, and/or the patient's anatomy.

Furthermore, in some embodiments, the docking device <NUM> can be physically attached or connected to the distal end <NUM> of the pusher <NUM>, <NUM>', in order to maintain connection and/or enable retrieval or pulling of the docking device <NUM> relative to the delivery catheter <NUM>. As shown in <FIG>, the pusher <NUM> (or <NUM>') can be formed with a central lumen <NUM> extending therethrough and an opening <NUM> at the distal tip of the pusher <NUM>. Lumen <NUM> and opening <NUM> can provide a passageway through which a retrieval or connecting line (e.g., a retrieval or connecting suture) or other connecting feature can pass, in order to connect the pusher or pusher wire/tube to a proximal end of the docking device <NUM>. As shown in <FIG>, a connecting or retrieval line/suture <NUM> can be threaded through lumen <NUM>, out of opening <NUM>, and through a hole near the proximal end of the docking device <NUM>, to connect the docking device <NUM> to the pusher <NUM>. The retrieval line/suture <NUM> can be threaded from the distal end <NUM> of the pusher <NUM> back through the central lumen <NUM>, and up to a proximal region of the pusher tool <NUM>. In one embodiment, the two ends of the retrieval line/suture <NUM> can be anchored at or connected to a handle or other portion of the pusher tool <NUM>, for example, to a locking knob <NUM> located on the enlarged head region <NUM> of the knob <NUM> (see, e.g., <FIG>). The locking knob <NUM> can provide easy access to the ends of the retrieval line/suture <NUM>, where for example, severing the retrieval or connecting line/suture <NUM> and/or pulling one side of the retrieval line/suture <NUM> until the retrieval line/suture <NUM> passes out of the through hole <NUM> on the docking device <NUM> disconnects the docking device <NUM> from the pusher or pusher wire/tube.

In another embodiment, shown in <FIG>, an exemplary locking knob or exemplary suture/line lock or locking mechanism is shown. The suture locking mechanism or line locking mechanism <NUM> in <FIG> can be a component that is added to an existing assembly, for example, an assembly that does not have an integrated suture locker. In some embodiments, the suture/line lock or locking mechanism <NUM> itself is integrated with other portions of a pusher or pusher tool <NUM>. The suture/line locker <NUM> can be used without the pusher tool <NUM> illustrated by <FIG>. For example, the suture locker <NUM> can be used with the pusher or pusher tube <NUM>' illustrated by <FIG>, without the pusher tool illustrated by <FIG>. The suture lock or locker <NUM> can include a generally T-shaped body having a first portion <NUM> and a second portion <NUM> that extends away from a central region of the first portion <NUM>.

A rotatable member <NUM> can be connected through and rotatable relative to the first portion <NUM> of the body, and can have a handle <NUM> at one end that extends outside of the first portion <NUM> of the body. The handle <NUM> can facilitate turning or rotating of the rotatable member <NUM> relative to the first portion <NUM> of the body. On an end of the rotatable member <NUM> opposite the handle <NUM>, an engagement feature <NUM> can be provided for anchoring or holding one or more ends of the connecting or retrieval line/suture <NUM> thereto. Meanwhile, a bore <NUM> can extend through the second portion <NUM> of the body to connect the first portion <NUM> of the body with a distal opening of the body. The bore <NUM> can create a suture route or pathway that allows the retrieval line/suture <NUM> to extend through the second portion <NUM> to the first portion <NUM> of the body, where the retrieval line/suture <NUM> can engage the rotatable member <NUM>. Here, the retrieval line/suture <NUM> can be passed through or over the rotatable member <NUM>, and can be anchored using the engagement feature <NUM>. When the retrieval line/suture <NUM> is anchored to the rotatable member <NUM>, the rotatable member <NUM> can act as a spool for the retrieval line/suture <NUM>, such that rotating the handle <NUM> adjusts an amount of the retrieval line/suture <NUM> that is wound around the rotatable member <NUM>, for increasing or decreasing a workable length and/or tension of the retrieval line/suture <NUM>. A slot/window/cut-out <NUM> can be formed in the suture/line locking mechanism <NUM> (e.g., in the second portion <NUM>), and the retrieval/connecting line/suture <NUM> can form a loop with one end or portion of the suture or loop extending over, across, and/or through the slot/window/cut-out <NUM>, such that the portion is exposed in the slot/window/cut-out <NUM> and can be cut by running a knife/scalpel along the slot/window/cut-out. Cutting the line/suture in this manner can break the loop and/or release the line/suture such that it can be withdrawn and pulled out from the docking device <NUM>, thereby releasing the docking device <NUM>.

Latching and/or other locks/locking mechanisms can also be incorporated into the suture/line locking mechanism <NUM> for maintaining a position or tension of the retrieval line/suture <NUM>. In some embodiments, the suture/line lock or locking mechanism <NUM> further includes a seal cap <NUM> for connecting the suture/line lock or locking mechanism <NUM> to other components of the delivery device <NUM>, and for example, for maintaining homeostasis through the delivery device <NUM> when the delivery device <NUM> is in use.

Referring back to <FIG> and <FIG>, when the respective parts of the pusher tool <NUM> are assembled together, complementary features between the various components also help facilitate a smoother and more robust operation of the pusher tool <NUM>. For example, a first region <NUM> of the tunnel <NUM> in the handle body <NUM> is positioned to be aligned with the slot <NUM> of the knob <NUM>, and to extend at a tangent to the spiraling wrapping direction of the slot <NUM>. In this manner, the pusher or pusher wire/tube <NUM> can extend, advance, and retract seamlessly between the slot <NUM> on the knob <NUM> and the first region <NUM> of the tunnel <NUM> in the handle body <NUM>, without any turns or direction changes between the components.

Additionally, guiding key <NUM> on handle body <NUM> can also be positioned along the spiraling wrapping direction of the slot <NUM>, for example, slightly distally to the opening into the first region <NUM> of the tunnel <NUM>. The guiding key <NUM> can be configured, sized and shaped to allow the guiding key <NUM> to extend into the slot <NUM>, and allow the slot <NUM> to slide over the guiding key <NUM>. When the guiding key <NUM> is positioned slightly distally to the first region <NUM> of the tunnel <NUM> into which the pusher wire <NUM> extends, portions of the slot <NUM> that reach the guiding key <NUM> are empty and do not hold the pusher or pusher wire/tube <NUM>. In this manner, the guiding key <NUM> can act as a track or guide for the axial positioning of the knob <NUM> relative to the handle body <NUM>, and prevent excess axial shifting therebetween. In this manner, the guiding key <NUM> can always ensure that the slot <NUM> is concentered and axially aligned with the tangential first region <NUM> of the tunnel <NUM> when the knob <NUM> is turned. The design of the pusher tool <NUM> also facilitates storing of a relatively long pusher or pusher wire/tube <NUM> in a relatively compact space in handle body <NUM>. For example, in one embodiment, a handle with a length of only about <NUM> can house and deploy a pusher or pusher wire/tube <NUM> with a functional length or travel length of up to <NUM>.

Operation of the pusher tool in an exemplary method will now be described in connection with delivery of a docking device to a native mitral valve, with reference to <FIG>. The pusher tool <NUM> shown is intended to be used together with a catheter handle, for example, catheter handle <NUM>, which can be locked together with at least the handle body <NUM> of the pusher tool <NUM>. In some embodiments, the handle body <NUM> of the pusher tool <NUM> is integrally formed with the catheter handle <NUM>. However, in each embodiment, the handle body <NUM> of the pusher tool <NUM> and catheter handle <NUM> can be coupled together, so that the catheter handle <NUM>, the delivery catheter <NUM>, and the handle body <NUM> of the pusher tool <NUM> are rotated concurrently. Therefore, when the knob <NUM> of the pusher <NUM> is held stationary, rotation of the catheter handle <NUM> will cause the distal region of the delivery catheter <NUM> to rotate, while simultaneously also rotating the handle body <NUM> of the pusher tool <NUM> relative to the knob <NUM>, resulting in either advancing or retracting of the pusher or pusher wire/tube <NUM> relative to the delivery catheter <NUM> depending on the direction of rotation. This arrangement provides for full control of the docking device <NUM> relative to the delivery catheter <NUM> during both deployment and retrieval of the docking device <NUM>.

Referring now to <FIG>, after the distal region of the delivery catheter <NUM> has been actuated or adjusted to an appropriate delivery configuration, the handle body <NUM> of the pusher tool <NUM> (and the catheter handle <NUM> if one is present) can be held stationary or fixed while the knob <NUM> is rotated, for example, in a clockwise direction relative to the other portions of the delivery device <NUM>. Rotation of the knob <NUM> can unwrap the pusher or pusher wire/tube <NUM> from the slot <NUM> of the knob <NUM> (see, e.g., <FIG>) and advance the pusher or pusher wire/tube <NUM> through the dedicated passageway formed by the tunnel <NUM> and out of the distal end of the handle body <NUM>. This shifts the pusher or pusher wire/tube <NUM> distally relative to the delivery catheter <NUM>, and consequently pushes the distal end of the pusher or pusher wire/tube <NUM> against the proximal end of the docking device <NUM> to advance the docking device <NUM> distally out of the distal opening of the delivery catheter <NUM>. As described above, the docking device <NUM> can be released from or pushed out of the delivery catheter <NUM> at an orientation that is substantially coincident with, or angled slightly downward relative to, the plane of the native valve annulus, and is then advanced through the native valve. For example, in the mitral valve, the docking device <NUM> is advanced through a commissure of the valve, and into the left ventricle. Optionally, all or only a first portion of the anchoring/docking device is advanced and/or deployed at the native valve or native annulus in this way.

The various anchoring/docking devices, delivery catheters, and/or guide sheaths described in various locations in this disclosure can include one or more radiopaque markers to aid in delivery and proper positioning of the anchoring/docking device, delivery catheter, and/or guide sheath. For example, viewing the relative movement and location of a radiopaque marker on the anchoring/docking device and a radiopaque marker on the delivery catheter can indicate when a predetermined or first portion (e.g., the encircling turn/coil and/or some or all of the functional turns/coils) of the anchoring/docking device has been pushed out of the delivery catheter and into the native annulus. In one example, an operator can rotate the knob and/or advance the pusher wire/tube such that the pusher wire/tube advances the anchoring/docking device until the predetermined or first portion of the anchoring/docking device has been deployed into the native annulus by watching the relative movement of the radiopaque marker on the anchoring/docking device and the radiopaque marker on the delivery catheter (e.g., watching for when they are aligned, which can indicate the first portion has been properly deployed from the delivery catheter).

Once a desired amount or the predetermined or first portion of the anchoring/docking device (which can be determined with the use of one or more radiopaque markers on the docking device and/or delivery catheter as discussed above) of the docking device <NUM> has been advanced into the chamber of the heart or ventricle (e.g., left ventricle or right ventricle) and the predetermined or first portion (e.g., the ventricular coils or encircling and/or functional coils) of the docking device <NUM> have been positioned satisfactorily or at the native annulus, a second portion (e.g., a stabilization coil/turn or atrial coil/turn) of the anchoring device can be delivered or deployed from the delivery catheter. This can be done in a variety of ways.

For example, the knob <NUM> and/or pusher tool can be held stationary or fixed, so that the pusher or pusher wire/tube <NUM> is held at a fixed position. In this manner, the ventricular coils of the docking device <NUM>, which is connected to or secured relative to the pusher wire/tube <NUM>, can also be held in place without losing a desired position. The pusher tool, pusher, and/or pusher wire/tube can be locked or fixed in position (e.g., by locking or fixing a proximal end thereof, such as in a stabilizer, and/or by locking/holding/maintaining the knob in position), while the delivery catheter is pulled or retracted proximally. This can hold the anchoring device in position (e.g., because the anchoring/docking device abuts the stationary pusher or pusher wire/tube) while the delivery catheter is retracted thereby unsheathing the second portion of the anchoring/docking device from the delivery catheter. If a guide sheath is used, the guide sheath can also be locked/fixed in position (e.g., in the stabilizer) while the delivery catheter is retracted. The pusher tool, delivery catheter, and/or guide sheath can be configured and/or arranged to be separately movable with respect to each other and separately securable in a stabilizer or other locking/stabilization mechanism.

In <FIG>, with the reference to the mitral valve, another method of retracting the delivery catheter is shown. While the knob <NUM> is held fixed, if appropriately configured, the handle body <NUM> of the pusher tool <NUM> (and the catheter handle <NUM> if one is present) can be rotated relative to the knob <NUM> in a direction opposite to the direction that the knob <NUM> was rotated, for example, in a counter-clockwise direction in the instant embodiment, causing the distal region of the delivery catheter <NUM> to also rotate in the same direction. The system and devices can be configured such that this rotational motion causes translational motion of the delivery catheter proximally to retract the delivery catheter from off the anchoring/docking device. Since the docking device <NUM> is held in place when the delivery catheter <NUM> is rotated, the delivery catheter <NUM> can be retracted relative to the docking device <NUM>, thereby releasing the second portion or atrial turn(s) of the docking device <NUM> from the delivery catheter <NUM>, without the docking device <NUM> advancing any further into the left ventricle or retracting back into the left atrium.

The handle body <NUM> of the pusher tool <NUM> can also be rotated relative to the knob <NUM>, which as best seen in <FIG> and <FIG>, will also result in release and further distal advancement of the pusher or pusher wire/tube <NUM> from the pusher tool <NUM>. The amount of advancement of the pusher or pusher wire/tube <NUM> can correspond substantially to the length of the docking device <NUM> that is released into the left atrium, so that the pusher or pusher wire/tube <NUM> provides sufficient slack to replace the length of the docking device <NUM> that was held in the delivery catheter <NUM> prior to deployment of the atrial turns, to further facilitate holding of the docking device <NUM> in place during this process.

Connection of the docking device <NUM> to the pusher or pusher wire/tube <NUM> via the retrieval line <NUM> (e.g., a retrieval suture) can also facilitate pulling of the docking device <NUM>, for example, to readjust or retrieve the docking device <NUM> from the implant site. Such retrieval is possible during any stage of delivery of the docking device <NUM>, and can be accomplished in similar manner as deployment of the docking device <NUM>. For example, if adjustment of the ventricular coils of the docking device <NUM> is desired, the position of the docking device <NUM> can be retracted or pulled backwards by rotating the knob <NUM> in the opposite direction to advancement, for example, counter-clockwise in this embodiment. In one embodiment, to hold the docking device <NUM> at the same position, while retracting a proximal portion (e.g., part of the stabilization coil/turn or atrial coil/turn) of the docking device <NUM> back into the delivery catheter <NUM>, the handle body <NUM> of the pusher tool <NUM> or the knob can be rotated in the opposite direction to advancement (e.g., clockwise in this embodiment). Partial or full retrieval of the docking device into the delivery catheter is possible.

Once the docking device <NUM> has been delivered to a desired position, the retrieval line/suture <NUM> can be released, for example, with the locking knob <NUM> or the suture/line locking mechanism <NUM> (e.g., by cutting along slot/window/cut-out <NUM> to cut a portion of the suture), the docking device <NUM> can be separated from the pusher wire/tube <NUM>, and the delivery device <NUM> can be removed from the implant site. The THV <NUM> can then be delivered to and expanded in the docking device <NUM> to complete the valve replacement procedure.

The delivery device <NUM> can be configured for delivering different shaped and oriented docking devices in other embodiments. For example, while the above example discusses clockwise advancement of the docking device <NUM>, the docking device <NUM> can be adapted for delivering a coil anchor that is advanced counter-clockwise as well, for example, the docking device <NUM> shown in <FIG>. In this arrangement, rotation of the respective parts would be in the opposite direction to the method discussed in <FIG>. For example, the knob <NUM> would be rotated in a counter-clockwise direction to advance the docking device <NUM> out of the delivery catheter <NUM>, while the knob would be rotated clockwise to retract the docking device <NUM> back into and/or further into the delivery catheter.

<FIG> illustrate an exemplary embodiment of a system <NUM> (which can include the same or similar features/components as system <NUM>) for delivering a docking device <NUM> to a native valve of a patient's heart. The system <NUM> includes a guide sheath <NUM> which houses and protects a delivery catheter <NUM>, which can be similar to or the same as the sheath <NUM> and the delivery catheter <NUM>, previously described. The delivery catheter <NUM> includes an open distal end <NUM> and central lumen <NUM>. The system <NUM> also includes a pusher tool <NUM> and a pusher or pusher wire/tube <NUM>, which can be the same as or similar to or the same as the pusher or pusher wire/tube <NUM>, <NUM>', previously described.

The pusher wire/tube <NUM> includes a proximal end <NUM> fixedly attached to the pusher tool <NUM> and a distal end <NUM> having a device abutment surface <NUM>. The pusher wire/tube <NUM> can include a central lumen <NUM> extending through the pusher wire/tube <NUM> from the proximal end <NUM> to the distal end <NUM>. The central lumen <NUM> can be open at the proximal end <NUM> via a proximal opening <NUM> and can be open at the distal end via a distal opening <NUM>.

The docking device <NUM> can include a proximal end <NUM> having one or more holes <NUM> extending transversely through the proximal end <NUM>. The system <NUM> can include a retrieval line/suture <NUM> that connects the docking device <NUM> to the pusher tool <NUM>. The retrieval line/suture <NUM> can extend from the pusher tool <NUM>, through the proximal opening <NUM>, through the central lumen <NUM>, out of the distal opening <NUM>, through the hole <NUM> in the docking device <NUM> and return to the pusher tool <NUM> along the same path (e.g., forming a loop). Thus, the retrieval line/suture <NUM> can have a first leg <NUM> and a second leg <NUM> extending from the pusher tool <NUM> to the docking device <NUM>.

The pusher tool <NUM> can include a suture/line locking mechanism the same as or similar to suture/line locking mechanism <NUM>. For example, pusher tool <NUM> can include a rotatable member <NUM> (e.g., the same as or similar to rotatable member <NUM> of suture/line locking mechanism <NUM> or the rotatable member can take any other form), which the retrieval line/suture <NUM> may wind around. By rotating the rotatable member <NUM>, the amount of the retrieval line/suture <NUM> that extends from the pusher tool <NUM> can be lengthened or shortened. As shown in <FIG>, the rotatable member <NUM> can be rotated such that the retrieval line/suture <NUM> draws the proximal end <NUM> of the docking device <NUM> against the device abutment surface <NUM>. In this position, the docking device <NUM> is held securely against the pusher wire/tube <NUM> such that the docking device <NUM> and the pusher wire/tube <NUM> move in unison. In this manner, movement of the pusher tool <NUM> relative to the delivery catheter <NUM> along the longitudinal axis A (<FIG>) of the system <NUM> can move the docking device <NUM> within the central lumen <NUM> of the delivery catheter <NUM>.

As shown in <FIG>, the pusher tool <NUM> and the pusher wire/tube <NUM> can be advanced relative to the delivery catheter <NUM> such that the docking device <NUM> is advanced out of the central lumen <NUM> and past the open distal end <NUM> of the delivery catheter <NUM>. The retrieval line/suture <NUM>, however, remains in tension such that the proximal end <NUM> of the docking device <NUM> is held against the device abutment surface <NUM> of the pusher wire/tube <NUM>.

As shown in <FIG>, once the docking device <NUM> has been pushed out of the delivery catheter <NUM> by the pusher or pusher wire/tube <NUM>, the pusher tool <NUM> can create slack in the retrieval line/suture <NUM> by allowing out additional length of the retrieval line/suture <NUM>. When tension in the retrieval line/suture <NUM> has been removed, the proximal end <NUM> of the docking device <NUM> is no longer held in engagement with the device abutment surface <NUM> of the pusher wire/tube <NUM>. During delivery, the docking device <NUM> can be held in the delivery catheter <NUM> in a relatively straight configuration for easier maneuverability through the delivery catheter <NUM>. After exiting the delivery catheter <NUM> and tension in the retrieval line/suture <NUM> is removed, the docking device <NUM> can return to its original coiled or curved shape and placement of the docking device <NUM> can be completed.

Since, however, the retrieval line/suture <NUM> remains connected to the docking device <NUM>, the docking device <NUM> can be retrieved or readjusted from the implant site by retracting the retrieval line/suture <NUM> back through the central lumen <NUM> of the pusher wire/tube <NUM> until the proximal end <NUM> of the docking device <NUM> is pulled into abutment with the device abutment surface <NUM> of the pusher wire/tube <NUM>. The pusher wire/tube <NUM> can then be pulled back through the central lumen <NUM> of the delivery catheter <NUM> and, if necessary, the docking device <NUM> can be wholly or partially pulled into the delivery catheter <NUM> for removal or replacement.

If the docking device <NUM> is properly implanted, the docking device <NUM> can be disconnected from the retrieval line/suture <NUM>, such as for example, by cutting or severing the retrieval line/suture <NUM> or a portion thereof. Once the docking device <NUM> is disconnected from the retrieval line/suture <NUM>, the pusher tool <NUM> and retrieval line/suture <NUM> can be withdrawn, leaving the docking device <NUM> in place. For example, one end of the retrieval line/suture <NUM> may be cut at or near the rotatable member <NUM> (e.g., in a slot/window/cut-out the same as or similar to slot/window/cut-out <NUM>). Once the end is cut, the rotatable member <NUM> can be rotated to draw the cut end down the pusher wire/tube <NUM> to the hole <NUM>, through the hole <NUM>, and back into the pusher wire/tube <NUM> to permanently release the docking device <NUM>. In another embodiment, both or either of the ends of the retrieval line/suture <NUM> may be cut with either end being drawn through the hole <NUM> to release the docking device <NUM>.

The pusher tool <NUM> can be configured in a variety of ways. Any tool capable of advancing the docking device <NUM> through the delivery catheter <NUM> while allowing controlled deployment and retrieval of the docking device <NUM> can be used. Referring to <FIG> and <FIG>, as shown in the illustrated exemplary embodiment, the pusher tool <NUM> includes a body <NUM> having a forward portion <NUM> adapted to receive and fixedly attach to the proximal end <NUM> of the pusher wire/tube <NUM> and a rearward portion <NUM> including a suture/line locking mechanism <NUM>, which can be the same as or similar to the suture/line locking mechanism <NUM> described above. The body <NUM> can be generally elongated and can include a pathway <NUM> (<FIG>) extending from the forward portion <NUM> to the suture/line locking mechanism <NUM>. The body <NUM> and pathway <NUM> can be formed as a single unitary structure or can be formed from a plurality of attached components and fittings. The number and type of components and fittings can vary in different embodiments.

The forward portion <NUM> can fixedly attach to the proximal end <NUM> of the pusher or pusher wire/tube <NUM> in any suitable manner, such as a friction fit, a threaded connection, adhesives, fasteners, or other suitable connections. As shown in the illustrated embodiment, the forward portion <NUM> can include a first connector <NUM> having a bore <NUM> sized to closely receive the proximal end <NUM> of the pusher wire/tube <NUM> such that the central lumen <NUM> of the pusher wire/tube <NUM> can communicate with the pathway <NUM> in the body <NUM>. As shown in the illustrated embodiment, the central lumen <NUM> can be coaxially aligned with the pathway <NUM> along an axis B (<FIG>) of the pathway <NUM>.

As shown in the illustrated exemplary embodiment, the first connector <NUM> can be attached to a flush fitting <NUM>. The first connector <NUM> may attach to the flush fitting <NUM> by any suitable manner, such as a friction fit, a threaded connection, adhesives, fasteners, or other suitable connections. As shown in the illustrated embodiment, the flush fitting <NUM> can be a T-fitting having a flush port <NUM> in fluid communication with the pathway <NUM>. The flush port <NUM> can be connected to or connectable to a flushing system <NUM> (<FIG>) for introducing a flushing fluid, such as saline, for example, into the pathway <NUM>. A sealing assembly <NUM> (<FIG>) can be provided in the flush fitting <NUM>, or otherwise between the flush fitting and the locking mechanism <NUM>, to prevent flushing fluid from entering the locking mechanism <NUM>.

The suture/line locking mechanism <NUM> can be attached to the rest of the body <NUM> of the pusher tool <NUM> in any suitable manner, such as a friction fit, a threaded connection, adhesives, fasteners, or other suitable connections. As shown in the illustrated embodiment, the suture/line locking mechanism <NUM> can be attached to the flush fitting <NUM> via a second connector <NUM> and a sealing cap <NUM>. In one exemplary embodiment, the connector <NUM> and sealing cap <NUM> allow the suture/line locking mechanism <NUM> to swivel relative to the remainder of the body <NUM>. The second connector <NUM> can include a distal end <NUM> that is received within a bore <NUM> of the flush fitting <NUM>, a proximal end <NUM> that is received within a bore <NUM> on the suture/line locking mechanism <NUM>, and a rearward facing shoulder <NUM> positioned between the distal end <NUM> and the proximal end <NUM>.

The sealing cap <NUM> can include a first end <NUM> that threadably engages the flush fitting <NUM> and a second end <NUM> having a bore <NUM> which the second connector <NUM> extends through. The shoulder <NUM> can abut an inner surface <NUM> of the sealing cap <NUM> adjacent the bore <NUM> to attach the second connector <NUM> to the flush fitting <NUM>. While the sealing cap <NUM> swivels, the distal end <NUM> presses against a gasket, which closes and seals the path of the retrieval line/suture <NUM>.

The suture/line locking mechanism <NUM> can be configured in a variety of ways. Any mechanism capable of anchoring the retrieval line/suture <NUM>, controlling the deployment and the retrieval of the retrieval line/suture <NUM>, and locking the retrieval line/suture <NUM> at a set deployment can be used. Referring to <FIG>, in one embodiment, the suture/line locking mechanism <NUM> includes a body <NUM> (which can be generally T-shaped) having a first portion <NUM> and a second portion <NUM> that extends away from a central region of the first portion <NUM>. The rotatable member <NUM> is received in the first portion <NUM> and rotatable about an axis C relative to the first portion <NUM> of the body <NUM>.

The second portion <NUM> can include a bore <NUM> for receiving the proximal end <NUM> of the second connector <NUM>. The bore <NUM> can extend the suture pathway <NUM> through the second portion <NUM> of the body <NUM> to the rotatable member <NUM> in the first portion <NUM> of the body <NUM>.

The second portion <NUM> can include a slot, window, or cut-out <NUM> (e.g., the same as or similar to slot/window/cut-out <NUM>) that provides access to the bore <NUM> from the exterior of the second portion <NUM>. The slot/window/cut-out <NUM> can be configured in a variety of ways. For example, the location, the size, and the shape of the slot/window/cut-out <NUM> can vary for different embodiments. Any opening that provides access to the bore <NUM> such that a user may access the retrieval line/suture <NUM> within the bore <NUM> can be used. In the illustrated embodiment, the slot/window/cut-out <NUM> is formed as a semi-circular, vertical channel.

A divider <NUM> can be positioned within the bore <NUM> adjacent the slot/window/cut-out <NUM>. The divider <NUM> can be configured in a variety of ways. Any structure that separates the two legs of the retrieval line/suture <NUM> within the bore <NUM> allowing one of the legs to be presented in the slot/window/cut-out <NUM> can be used. In the illustrated embodiment, the divider <NUM> is a dowel pin arranged vertically in the bore <NUM> and sized and positioned such that one leg of the retrieval line/suture <NUM> can pass on one side of the divider <NUM> and the other leg of the retrieval line/suture <NUM> can pass on the opposite side of the divider <NUM>.

As shown in the illustrated embodiment, the first portion <NUM> can be formed by a generally cylindrical sidewall <NUM> defining a bore <NUM> extending from a first end <NUM> of the first portion <NUM> to a second end <NUM> opposite the first end <NUM>. In some embodiments, however, the first portion <NUM> can be shaped other than cylindrical. The first portion <NUM> can include a radial lip <NUM> extending from the exterior of the cylindrical sidewall <NUM> proximate the first end <NUM>.

The suture/line locking mechanism <NUM> can also include components or structure for locking the rotational position of the rotatable member <NUM> relative to the first portion <NUM>. The components or structure can be configured in a variety of ways. Any components or structure capable of locking the rotational position of the rotatable member <NUM> relative to the first portion <NUM> can be used, such as for example, a splined connection. As shown in the illustrated embodiment, the first end <NUM> of the first portion <NUM> can include a gear-shaped first opening <NUM> in an end wall <NUM> of the first end <NUM>. The first opening <NUM> can be axially aligned with the bore <NUM> along the axis C. The gear shape of the opening <NUM> can be formed by alternating radially extending projections <NUM> and recesses <NUM> spaced circumferentially around the first opening <NUM>. As will be described in detail below, the projections <NUM> can act as stops that prevent rotation of the rotatable member <NUM>. The number and size of the projections <NUM> and recesses <NUM> can vary in different embodiments. As shown in the illustrated embodiment, the gear shape of the opening <NUM> can be formed by nine alternating projections <NUM> and recesses <NUM>. Each projection <NUM> and each recess <NUM> can be about <NUM> degrees apart from the next projection and recess, respectively.

The first end <NUM> can include a counter-bore <NUM> adjacent the first opening <NUM>. The counter-bore <NUM> can be coaxially aligned with the bore <NUM> but can have a larger diameter than the bore <NUM>. The first portion <NUM> of the suture/line locking mechanism <NUM> can also include a hole <NUM> that extends through the cylindrical sidewall <NUM> opposite and coaxial with the bore <NUM> of the second portion <NUM>.

The second end <NUM> of the first portion <NUM> can include a second opening <NUM> opposite the first opening <NUM> and coaxial with the bore <NUM>. The second opening <NUM> can have the same size and shape as the bore <NUM> or can have a different size and shape. As shown in the illustrated embodiment, the second end <NUM> can include a tapered or beveled exterior edge <NUM>.

One or more stops <NUM> can be positioned between the hole <NUM> and the second opening <NUM> along the inner surface of the sidewall <NUM>. The one or more stops <NUM> can be configured in a variety of ways, such as for example, the shape, size, and number of stops. Any structure capable of restricting axial movement of the rotatable member <NUM> can be used. As shown in the illustrated embodiment, the one or more stops <NUM> can include a pair of dowel pins. For example, the first portion <NUM> can include a pair of offset bores <NUM> (<FIG>), each sized to receive one of the stops <NUM> and extending through the first portion <NUM> to form two recessed grooves <NUM> along an inner surface of the bore <NUM> opposite each other. When received in the offset bores <NUM>, the stops <NUM> reduce the cross-sectional size of the bore <NUM> to create a choke-point.

The rotatable member <NUM> of the suture/line locking mechanism <NUM> can be configured in a variety of ways. Any configuration capable of engaging the retrieval line/suture <NUM> to deploy and retrieve the retrieval line/suture <NUM> can be used. For example, the rotatable member <NUM> can be configured such that manually rotating the rotatable member <NUM> winds or unwinds the retrieval line/suture <NUM> from around a portion of the rotatable member. As shown in the illustrated embodiment, the rotatable member <NUM> can include a handle <NUM> and a stem <NUM> extending from the handle <NUM>. The handle <NUM> can be positioned at one end of the rotatable member <NUM> and extend outside of the first portion <NUM> of the T-shaped body <NUM>. The handle <NUM> can be configured in a variety of ways. Any configuration that facilitates turning or rotating of the rotatable member <NUM> relative to the first portion <NUM> of the T-shaped body <NUM> can be used.

The stem <NUM> can be generally cylindrical and sized to be received within the bore <NUM> of the first portion <NUM>. As shown in the illustrated embodiment, the stem <NUM> can include a proximal portion <NUM> adjacent the handle <NUM>, a first reduced diameter portion <NUM> adjacent the proximal portion <NUM>, a second reduced diameter portion <NUM> separated from the first reduced diameter portion <NUM> by a radial lip <NUM>, and a distal end portion <NUM> adjacent the second reduced diameter portion <NUM>. The stem <NUM> can include an inner passage <NUM> extending axially from the proximal portion <NUM> through the distal end portion <NUM> to form an opening <NUM> in the distal end portion <NUM>.

The proximal portion <NUM> can include a radially extending projection <NUM> (<FIG>). The projection <NUM> is configured to interact with the gear-shaped first opening <NUM>. In particular, the projection <NUM> is sized to be received within one of the recesses <NUM> between two of the projections <NUM>. The projection <NUM> can be configured in a variety of ways. For example, the projection <NUM> can be integrally formed with the stem <NUM> or can be a separate component that is attached, or otherwise connected, to the rotatable member <NUM>. As shown in the exemplary embodiment, the stem <NUM> can include a radially extending bore <NUM> proximate the handle <NUM> that receives the projection <NUM> in the form of a dowel pin.

The first reduced diameter portion <NUM> can include a cross-bore <NUM> that communicates with the inner passage <NUM>. In the illustrated embodiment, the cross-bore <NUM> extends through the first reduced diameter portion <NUM> generally perpendicular to the longitudinal axis C and has the same or similar diameter to the pathway <NUM>. In some embodiments, however, the cross-bore <NUM> may be shaped, sized, and oriented differently.

As shown in <FIG>, the rotatable member <NUM> can include an anchoring or engagement feature <NUM> for anchoring or holding one or more ends of the retrieval line/suture <NUM>. The anchoring or engagement feature <NUM> can be configured in a variety of ways. Any feature capable of anchoring or holding one or more ends of the retrieval line/suture <NUM> can be used. As shown in the illustrated embodiment, the anchoring or engagement feature <NUM> can be cylindrical or generally cylindrical and can be sized to be received in the inner passage <NUM> at the distal end portion <NUM> of the rotatable member <NUM>. The anchoring or engagement feature <NUM> can include a pair of passages <NUM> extending generally parallel to the inner passage <NUM>. Each of the passages <NUM> can be sized to receive an end of the retrieval line/suture <NUM>. In some embodiments, the anchoring or engagement feature <NUM> can include more or less than a pair of passages <NUM>.

Referring to <FIG>, when assembled, the stem <NUM> of the rotatable member <NUM> can be slideably and rotatably received within the bore <NUM> of the first portion <NUM> of the suture/line locking mechanism <NUM> and the handle <NUM> extends from the first end <NUM>. The cross bore <NUM> of the rotatable member <NUM> can be in communication with the pathway <NUM> and the anchoring or engagement feature <NUM> can be positioned in the inner passage <NUM> at the distal end portion <NUM> of the rotatable member <NUM>.

The first leg <NUM> and the second leg <NUM> of the retrieval line/suture <NUM> can extend from the docking device <NUM>, through the pusher or pusher wire/tube <NUM>, through the pathway <NUM>, and into the rotatable member <NUM> via the cross-bore <NUM>. From the cross-bore <NUM>, the first leg <NUM> and the second leg <NUM> of the retrieval line/suture <NUM> can enter the inner passage <NUM> and extend along the inner passage <NUM> to the anchoring or engagement feature <NUM> at the distal end portion <NUM>. At the anchoring or engagement feature <NUM>, the first leg <NUM> of the retrieval line/suture <NUM> can extend through one of the pair of passages <NUM> and the second leg <NUM> of the retrieval line/suture <NUM> can extend through the other of the pair of passages <NUM>. Once through the passages <NUM>, the first leg <NUM> and the second leg <NUM> can be anchored in place, such as for example, by being tied together or knotted at their ends.

In one embodiment, as the first leg <NUM> and the second leg <NUM> of the retrieval line/suture <NUM> extend through the pathway <NUM> past the divider <NUM>, the first leg <NUM> of the retrieval line/suture <NUM> passes along one side of the divider <NUM> and the second leg <NUM> passes along the opposite side of the divider <NUM> such that the divider <NUM> separates the two legs <NUM>,<NUM>.

The stem <NUM> of the rotatable member <NUM> can be positioned within the bore <NUM> such that the second reduced diameter portion <NUM> is adjacent the recessed grooves <NUM> on the inner surface of the bore <NUM>. The stops <NUM>, when inserted in the recessed grooves <NUM>, extend, at least partly, into the second reduced diameter portion <NUM> and between the radial lip <NUM> and the distal end portion <NUM> of the stem <NUM>. Thus, axial movement of the rotatable stem <NUM> of the rotatable member <NUM> within the bore <NUM> can be limited by the stops <NUM>.

The rotatable member <NUM> can be axially moveable within the bore <NUM> between a first position and a second position. The suture/line locking mechanism <NUM> can include a biasing member <NUM> that biases the rotatable member <NUM> to the first position. The biasing member <NUM> can be configured in a variety of ways. Any biasing member capable of biasing the rotatable member <NUM> to the first position can be used. As shown in the illustrated embodiment, the biasing member <NUM> can be a spring positioned between the radial lip <NUM> and an underside surface <NUM> of the handle <NUM> to bias the handle <NUM> away from the T-shaped body <NUM>.

Referring to <FIG>, in the illustrated first position, the distal end portion <NUM> of the stem <NUM> engages the stops <NUM> to prevent further upward axial movement of the rotatable member <NUM>. The cross-bore <NUM> is positioned to communicate with the pathway <NUM>. In the illustrated embodiment, the cross-bore <NUM> is coaxially aligned with the pathway <NUM>. In some embodiments, however, the cross-bore <NUM> need not be coaxially aligned with the pathway <NUM> in the first position.

At the proximal portion <NUM> of the stem <NUM>, the projection <NUM> can be positioned in one of the plurality of recesses <NUM> between adjacent projections <NUM>. Thus, the radially extending projections <NUM> can prevent rotation of the rotatable member <NUM> by engaging the projection <NUM>. The first position, therefore, can be a locked position.

Referring to <FIG>, in the illustrated second position, the rotatable member <NUM> is moved downward relative to the T-shaped body <NUM> against the bias of the biasing member <NUM>. The radial lip <NUM> engages the stops <NUM> to prevent further downward axial movement of the rotatable member <NUM>. The cross-bore <NUM>, while not aligned with the pathway <NUM>, is still positioned to communicate with the pathway <NUM>. At the proximal portion <NUM> of the stem <NUM>, the projection <NUM> is positioned in the counter bore <NUM> of the first portion <NUM> below the plurality of recesses <NUM> and radially extending projections <NUM> of the first opening <NUM> (see <FIG>). Thus, the rotatable member <NUM> is able to rotate about the axis C. The second position, therefore, is a rotatable position.

In operation, a user can move the handle <NUM> to the second position, for example, by pushing it downward relative to the T-shaped body <NUM>. In the second position, the rotatable member <NUM> can be rotated by the handle <NUM>. Rotating the rotatable member <NUM> in a first direction, such as for example, clockwise, can wind a portion of the retrieval line/suture <NUM> around the first reduced diameter portion <NUM> of the stem <NUM>; thus, retrieving or reducing the amount of retrieval line/suture <NUM> that extends from the suture/line locking mechanism <NUM>. Rotating the rotatable member <NUM> in a second direction opposite the first direction, such as for example, counterclockwise, can unwind a portion of retrieval line/suture <NUM> from first reduced diameter portion <NUM> of the stem <NUM>; thus, deploying or increasing the amount of retrieval line/suture <NUM> that extends from the suture/line locking mechanism <NUM>. In one embodiment, to lock the amount of retrieval line/suture <NUM> that has been deployed, the user can release the handle <NUM> allowing the biasing member <NUM> to move the rotatable member <NUM> to the first position; thus preventing the rotatable member <NUM> from rotating. Locking the retrieval line/suture <NUM> by wrapping the retrieval line/suture <NUM> around the rotatable member <NUM> and preventing the rotatable member <NUM> is a friction locking method that reduces the risk of the retrieval line/suture <NUM> tearing when compared to locking methods which are based on clamping the retrieval line/suture <NUM>, especially with thin retrieval lines/sutures.

To release the docking device <NUM> from the retrieval line/suture <NUM>, the first leg <NUM>, the second leg <NUM>, or both legs of the retrieval line/suture <NUM> can be cut at the slot/window/cut-out <NUM> in the second portion <NUM> of the body <NUM>. For example, in the illustrated embodiment, since the first leg <NUM> and the second leg <NUM> of the retrieval line/suture <NUM> are separated in the pathway <NUM> adjacent the slot/window/cut-out <NUM> by the divider <NUM>, only a single leg is presented at the slot/window/cut-out <NUM>, with the other leg being positioned behind the divider <NUM>. The single leg in front of the divider <NUM>, therefore, can be cut without concern for cutting the other leg. Once one of the first or the second leg <NUM>, <NUM> is cut, the cut or severed end of the retrieval line/suture <NUM> can be pulled through the central lumen <NUM> toward the docking device <NUM>, through the hole <NUM> in the docking device <NUM> to release the docking device <NUM>, and back through the central lumen <NUM> of the pusher wire. This can be accomplished by in a number of ways. For example, the handle <NUM> can simply be pressed down and rotated to wind the retrieval line/suture <NUM> onto the stem <NUM>. Or, the suture/line locking mechanism <NUM> can be disconnected from the pusher tool <NUM> by disconnecting the first end <NUM> of the sealing cap <NUM> from the flush fitting <NUM>. Since the retrieval line/suture <NUM> is attached to the suture/line locking mechanism <NUM>, removing the suture/line locking mechanism <NUM> from the rest of the pusher tool <NUM> will pull the retrieval line/suture <NUM> through the hole <NUM> and disconnects the docking device <NUM>.

Optionally, the various pushers (e.g., pusher wires, pusher tubes, etc.) described herein can have a coating over and/or inside it, e.g., the pushers can have an interior lumen lined by PTFE to allow a line (e.g., a suture) to be atraumatically actuated through the lined lumen.

The various manipulations and controls of the systems and devices described above can be automated and/or motorized. For example, the controls or knobs described above can be buttons or electrical inputs that cause the actions described with respect to the controls/knobs above. This can be done by connecting (directly or indirectly) some or all of the moving parts to a motor (e.g., an electrical motor, pneumatic motor, hydraulic motor, etc.) that is actuated by the buttons or electrical inputs. For example, the motor can be configured, when actuated, to cause the control wires or pull wires described herein to tension or relax to move the distal region of the catheter. Additionally or alternatively, the motor could configured, when actuated, to cause the pusher to move translationally or axially relative to the catheter to cause an anchoring or docking device to move within and/or into or out of the catheter. Automatic stops or preventative measures could be built in to prevent damage to the system/device and/or patient, e.g., to prevent movement of a component beyond a certain point.

Additional systems, devices, components, methods, etc. are described in <CIT>, and titled "DEPLOYMENT TOOLS AND METHODS FOR DELIVERING AN ANCHORING DEVICE FOR A PROSTHETIC VALVE AT A NATIVE VALVE ANNULUS" and the related PCT Patent Application Serial No. <CIT>.

Furthermore, while only transseptal delivery of the docking device <NUM> has been discussed in detail, the tools and methods can be modified in other embodiments for other delivery procedures, for example, transatrial or transapical delivery. In addition, as has been discussed, while embodiments of the docking device <NUM> and delivery devices have generally been discussed above with respect to valve replacement at the mitral position, similar docking devices and delivery methods can also be applied at other valve sites as well, for example, at the tricuspid, pulmonary, or aortic valve positions. Docking devices similar to or the same as those discussed above, when applied to valves other than the mitral valve, can also provide a more secure landing zone for THVs at those sites as well.

Claim 1:
A delivery device (<NUM>) for delivering an anchoring device (<NUM>) to a native valve annulus of a patient's heart, where the anchoring device (<NUM>) is usable to secure a prosthetic heart valve at the native valve annulus, the delivery device (<NUM>) comprising:
a delivery catheter (<NUM>) having a distal region configured such that it can transition from a first shape to a second shape different from the first shape, the second shape being curved; and
a pusher tool (<NUM>), the pusher tool (<NUM>) comprising:
a body (<NUM>) rotationally fixable relative to the delivery catheter (<NUM>);
a control (<NUM>) connected to the body (<NUM>); and
a pusher (<NUM>) connected to the control (<NUM>);
wherein the pusher (<NUM>) is configured to extend through the body (<NUM>) to the delivery catheter (<NUM>), and to move translationally in the delivery catheter (<NUM>) when the control (<NUM>) is actuated, to move the anchoring device (<NUM>) within and/or out of the delivery catheter (<NUM>).