Systems, devices, and methods for treating heart valves

Abstract

Systems, assemblies, and methods for treating valve regurgitation and other valve problems are described. Prosthetic valves can have integrated coverings or flanges. Prosthetic valves can have inflow ends attached to an annular frame and flanges designed to extend outwardly therefrom. Docking devices can be used to repair or reshape native heart valves and secure prosthetic heart valves in a particular location and position relative to the native heart valve. Delivery systems can be used to deploy docking devices into the heart, including lubricious sleeves in the delivery system. Packaging and storage systems suitable for the delivery systems are described.

Description

[0001] Cross-reference to related applications

[0002] This application claims the benefits of U.S. Provisional Application Serial No. 62 / 908,402, entitled "Systems, Devices, and Methods for Treating Heart Valves," filed September 30, 2019, and U.S. Provisional Application Serial No. 62 / 858,875, entitled "Systems, Devices, and Methods for Treating Heart Valves," filed June 7, 2019; the disclosures of which are incorporated herein by reference in their entirety. Technical Field

[0003] This disclosure relates to systems and methods for treating valvular regurgitation and / or other valvular problems. Background Technology

[0004] Artificial heart valves can be used to treat valvular heart disease. Natural heart valves (aortic, pulmonary, tricuspid, and mitral valves) play a vital role in ensuring an adequate supply of blood to flow forward through the cardiovascular system. The effectiveness of these heart valves can be reduced due to congenital factors, inflammation, infection, and other conditions. This can ultimately lead to serious cardiovascular damage or death.

[0005] Transcatheter techniques can be used to deliver and implant artificial heart valves using a flexible catheter in a less invasive manner than open-heart surgery. In this technique, the artificial valve can be mounted in a coiled state on the distal portion of a flexible catheter and advanced through the patient's blood vessels until the artificial valve reaches the implantation site. The valve at the distal end of the catheter can then be expanded to its functional size at the site of a defective natural valve, such as by inflating a balloon with the valve attached. Alternatively, the valve can have a resilient, self-expanding stent or frame that expands the valve to its functional size as it is advanced from a delivery sheath at the distal end of the catheter. Optionally, the valve can have a mechanically expandable frame, or the valve can have a combination of expansion mechanisms, such as balloon-expandable, self-expanding, and / or mechanically expandable portions.

[0006] In theory, transcatheter heart valves (THVs) are sized or shaped appropriately to be placed inside native mitral and tricuspid valves. However, mitral and tricuspid valve anatomies can vary from person to person, and it can be difficult to properly size and shape the valve for many patients. Additionally, when treating valve insufficiency, the surrounding tissue can not be strong enough to hold certain types of valves in place as needed. It would be beneficial to have docking systems and / or devices that secure the prosthetic valve in place and appropriate delivery systems that ensure safe and effective delivery. Additionally, the shape of the native valve can allow for paravalvular leakage (i.e., blood flow around the prosthetic valve) around the prosthetic valve. Accordingly, solutions that increase the efficiency of prosthetic valve placement and reduce paravalvular leakage would be beneficial. SUMMARY

[0007] This summary is intended to provide examples and is not intended to limit the scope of the application in any way. For example, any feature of the examples included in this summary is not required by the claims unless expressly recited by the claims. This specification discloses exemplary embodiments of prosthetic valves, expansion docking devices for prosthetic valves, delivery devices for docking devices, and packaging for delivery devices. Docking devices, catheters, and handles can be configured in a variety of ways. Also, described features can be combined in a variety of ways. Various features and steps as described elsewhere in this disclosure can be included in the examples summarized here.

[0008] In some embodiments, the systems and / or devices herein include a docking device (e.g., an anchor or the like), a delivery system, a prosthetic or implantable heart valve, a pusher device, other components, or a combination of one or more of these. The docking device, delivery system, prosthetic valve, etc. can be the same as or similar to those described below or elsewhere herein.

[0009] In one representative embodiment, a suture lock assembly for a delivery system of an implantable medical device can include a spool configured to receive a suture and including a gear, a turnable handle coupled to the spool and configured to rotate the spool and the gear, a pawl configured to engage with teeth of the gear and allow the gear, the spool, and the handle to rotate in only one direction, and an orientation selector coupled to the pawl and movable between two positions, each of the two positions corresponding to a different rotational direction of the gear, the orientation selector configured to pivot the pawl to adjust an orientation of the pawl relative to the gear and adjust the rotational direction of the gear.

[0010] In some embodiments, the pawl is pivotable between a first orientation that only allows the gear to rotate in a first direction and a second orientation that only allows the gear to rotate in a second, opposite direction. In some embodiments, the first direction is counterclockwise and the second direction is clockwise.

[0011] In some embodiments, the pawl is held in the first orientation and the second orientation by a spring plunger engaged with the pawl at a back side of the pawl, and wherein in the first orientation the pawl is disposed on a first side of the spring plunger and in the second orientation the pawl is disposed on a second side of the spring plunger.

[0012] In some embodiments, the pawl includes two teeth spaced apart from each other and disposed on a front side of the pawl, and the two teeth of the pawl are configured to engage with the teeth of the gear.

[0013] In some embodiments, the suture locking assembly further includes a hard stop disposed within a housing of the suture locking assembly, the gear and the pawl disposed within the housing, and the pawl is configured to engage with one of the hard stops when the gear is rotated in a direction opposite to a selected rotation direction set by the orientation selector.

[0014] In some embodiments, the suture locking assembly further includes a housing including a top housing and a bottom housing coupled to each other, the gear and the pawl disposed within a space disposed between the top housing and the bottom housing. The rotatable handle and the orientation selector can extend outwardly from the top housing. The top housing can include a first icon indicating a relaxed position of the orientation selector and a second icon indicating a tensioned position of the orientation selector, and wherein the orientation selector is movable between a first of the two positions pointing to the first icon and a second of the two positions pointing to the second icon.

[0015] In some embodiments, the suture locking assembly further includes a release rod including a suture cutting location disposed at a distal end of the release rod, the release rod configured to receive a suture through an interior of the release rod and through the suture cutting location, the suture extending from a spool.

[0016] In some embodiments, the release rod includes one or more support ribs disposed on a central portion of the release rod, the central portion disposed between the distal end and a proximal end of the release rod.

[0017] In some embodiments, the distal end of the release rod is shaped to form a first keyed connection with an adapter of a delivery system, and the proximal end of the release rod is shaped to form a second keyed connection with a bottom housing of the suture locking assembly, wherein the spool is disposed within an interior of the bottom housing.

[0018] In some embodiments, the suture locking assembly further comprises a flush port coupled to the bottom housing and extending outwardly therefrom in a direction opposite to a direction in which the release lever extends from the bottom housing.

[0019] In some embodiments, the suture locking assembly further comprises a plurality of annular sealing elements, including: a first annular sealing element disposed about a distal end portion of the release lever proximate to the suture cutting location; and a second annular sealing element disposed about a proximal end portion of the release lever between the release lever and a bottom housing of the suture locking assembly in a radial direction, wherein the spool is disposed within the bottom housing. In some embodiments, the plurality of annular sealing elements further comprises a third annular sealing element disposed about a portion of the spool and between the portion of the spool and the bottom housing.

[0020] In some embodiments, a proximal end of the release lever is bonded to the bottom housing of the suture locking assembly.

[0021] In some embodiments, the release lever comprises a divider disposed within the suture cutting location, wherein the divider is configured to separate two strands of suture extending longitudinally through the release lever and expose only one of the two strands of suture to an exterior of the suture locking assembly at the suture cutting location.

[0022] In some embodiments, the spool comprises a gap in a flange disposed about a bottom of the spool, and the rotatable handle comprises an indicator on an outer surface thereof configured to track a number of turns applied to the spool and position the gap.

[0023] In some embodiments, the gap is disposed proximate to one or more apertures disposed within the spool, the one or more apertures configured to extend suture from an interior of the spool to an outer surface of the spool, the outer surface of the spool configured to receive suture thereon.

[0024] In some embodiments, the rotatable handle is coupled to the spool via a central screw extending longitudinally through the rotatable handle and the spool, and the suture locking assembly can further comprise one or more friction pads disposed about the central screw proximate to a central portion of the spool; and a friction nut coupled to the central screw below a lower friction pad of the one or more friction pads. The one or more friction pads can be configured to increase friction on the central screw to stop rotation of the central screw and the rotatable handle when tension in the suture increases above a predetermined threshold.

[0025] In some embodiments, the suture locking assembly further comprises a pin-based clutch system including a spring plunger extending longitudinally through and coupled to a portion of the rotatable handle, the spring plunger including an end portion extending into the gear and configured to extend into and cooperate with a plurality of detents arranged in an outward-facing surface of the gear to allow the gear to be rotated by the rotatable handle. The spring plunger can be configured to slide out of the detents in response to a tension in the suture exceeding a predetermined threshold.

[0026] In another representative embodiment, a delivery system for delivering a docking device to a native valve annulus of a heart of a patient can include an outer shaft and a sleeve shaft at least partially arranged within the outer shaft. The sleeve shaft can include a distal section configured to cover the docking device, the distal section comprising a flexible material having a lubricious outer surface, and a proximal section comprising a rigid material and including a tubular portion and a cut portion having an open U-shaped cross-section. The delivery system can further include a pusher shaft at least partially arranged within the outer shaft, the pusher shaft including a main tube arranged inside the sleeve shaft in a radial direction relative to a central longitudinal axis of the delivery system, an annular housing encircling a proximal end portion of the main tube and spaced apart from an outer surface of the main tube in the radial direction, and a proximal extension connected to the main tube and extending proximally from a proximal end of the main tube proximal of the housing, the proximal extension comprising a flexible material and extending along a portion of an inner surface of the cut portion of the proximal section of the sleeve shaft.

[0027] In some embodiments, the pusher shaft further includes an annular plug arranged within the annular housing at a proximal end of the housing and encircling the main shaft, wherein the plug includes a crescent-shaped portion extending through and filling a first portion of an annular space arranged between the main tube and the housing.

[0028] In some embodiments, the annular space includes a second portion that is open and unfilled by the plug, wherein the proximal section of the sleeve shaft is configured to slide within the annular space, and wherein the cut portion of the proximal section is configured to slide through the second portion of the annular space.

[0029] In some embodiments, the tubular portion of the proximal section has an end face at an interface between the tubular portion and the cut portion, the end face being arranged orthogonal to the central longitudinal axis, and the plug is configured to engage with the end face of the proximal section and prevent further travel of the sleeve shaft in a proximal axial direction.

[0030] In some embodiments, the sleeve shaft further includes an intermediate section arranged between the distal portion and the proximal portion of the sleeve shaft, the intermediate section forming a transition between the flexible material of the distal portion and the rigid material of the proximal portion.

[0031] In some embodiments, the sleeve shaft further comprises a flexible polymer jacket forming an outer surface of the distal section and the intermediate section, the flexible polymer jacket comprising a flexible material; an inner liner forming an inner surface of each of the distal section and the intermediate section; and a rigid tube comprising a first section forming the entire proximal section and a second section forming a proximal portion of the intermediate section.

[0032] In some embodiments, the rigid tube is a metal tube, wherein the second section comprises a plurality of apertures disposed about a perimeter of the rigid tube along the second section, and wherein the rigid tube is coupled to the inner liner and the flexible polymer jacket via a bond between the inner liner and the flexible polymer jacket through the plurality of apertures.

[0033] In some embodiments, the delivery system further comprises a handle assembly comprising a handle portion and a hub assembly extending proximally from a proximal end of the handle portion, wherein the outer shaft extends distally from a distal end of the handle portion, and wherein the hub assembly comprises an adapter having a straight section coupled to the suture lock assembly and a branch section coupled to the sleeve actuation handle.

[0034] In some embodiments, the proximal extension of the pusher shaft extends into and through a portion of the branch section of the adapter.

[0035] In some embodiments, the delivery system further comprises a first irrigation port coupled to the branch section of the adapter and fluidly coupled to a lumen of the proximal extension of the pusher shaft. In some embodiments, the delivery system further comprises a second irrigation port coupled to the branch section distally of the first irrigation port and fluidly coupled to a lumen formed between an outer surface of the proximal extension and an inner surface of the branch section.

[0036] In some embodiments, the delivery system further comprises a first irrigation port coupled to a proximal end of the suture lock assembly and fluidly coupled to an internal lumen of the proximal extension of the pusher shaft and a second irrigation port coupled to the branch section distally of the first irrigation port and fluidly coupled to a lumen formed between an outer surface of the proximal extension and an inner surface of the branch section.

[0037] In some embodiments, the cutting portion of the sleeve shaft extends into and is coupled to the sleeve actuation handle.

[0038] In some embodiments, the pusher shaft and the sleeve shaft are coaxial with one another along a central longitudinal axis of the delivery system, and each of the sleeve shaft and the pusher shaft are configured to slide axially along the central longitudinal axis relative to the outer shaft.

[0039] In some embodiments, the distal section of the main shaft of the pusher shaft includes a plurality of cutouts therein, the cutouts spaced apart from one another along the length of the distal section, wherein the plurality of cutouts are configured to increase the flexibility of the distal section of the main shaft. In some embodiments, the spacing between adjacent cutouts of the plurality of cutouts varies along the length of the distal section, and wherein the spacing between adjacent cutouts increases from the distal end to the proximal end of the distal section.

[0040] In another representative embodiment, a delivery system for delivering a docking device to a native valve annulus of a heart of a patient includes a handle portion, an outer shaft extending distally from a distal end of the handle portion, a sleeve shaft extending through an interior of the outer shaft and configured to cover the docking device, a pusher shaft including a main shaft extending through an interior of the sleeve shaft, and a hub assembly extending proximally from a proximal end of the handle portion. The hub assembly can include an adapter coupled to the handle portion and including a first section and a second section branching from the first section, wherein a portion of the pusher shaft extends into the second section and a proximal section of the sleeve shaft extends through the first section, a suture lock assembly coupled to a proximal end of the second section and configured to adjust tension in a suture extending from the suture lock assembly through the pusher shaft to the docking device, a first irrigation port coupled to the second section and fluidly coupled to a first fluid flow lumen disposed within the interior of the pusher shaft and fluidly coupled to a second fluid flow lumen disposed between the sleeve shaft and the docking device, and a second irrigation port coupled to the second section and fluidly coupled to a third fluid flow lumen disposed between the outer shaft and the sleeve shaft.

[0041] In some embodiments, the delivery system further includes a sleeve actuation handle disposed at the proximal end of the first section and coupled to an end of the proximal section of the sleeve shaft, the sleeve actuation handle configured to adjust an axial position of the sleeve shaft relative to the outer shaft.

[0042] In some embodiments, the first fluid flow lumen extends through an interior of a proximal extension of the pusher shaft and an interior of the main shaft of the pusher shaft, the main shaft coupled to the proximal extension and extending through an interior of the outer shaft, and the proximal extension extending through a portion of the outer shaft and into the second section.

[0043] In some embodiments, the first fluid flow lumen extends to a distal end of the pusher shaft, the distal end disposed adjacent to but spaced apart from a proximal end of the docking device when the docking device is disposed within the outer shaft.

[0044] In some embodiments, the second irrigation port is coupled to a third fluid flow lumen via an annular cavity disposed between an outer housing of the push rod shaft and a main tube of the push rod shaft, and a fourth fluid flow lumen formed between an outer surface of the proximal extension and an inner surface of the second section, the fourth fluid flow lumen fluidly coupled to the annular cavity. In some embodiments, the third fluid flow lumen is disposed between an inner surface of the outer shaft and a distal portion of the sleeve shaft, the distal portion configured to cover the docking device when the docking device is disposed inside the outer shaft and implanted at the native valve annulus.

[0045] In some embodiments, the delivery system further comprises a third irrigation port coupled to the handle portion and fluidly coupled to the annular cavity.

[0046] In some embodiments, the delivery system further comprises a grommet disposed within and through a diameter of the second section between a location where the first irrigation port is coupled to the second section and a location where the second irrigation port is coupled to the second section. The grommet is configured to fluidly separate the first fluid flow lumen and the third fluid flow lumen from each other.

[0047] In some embodiments, the first irrigation port and the second irrigation port are connected to a single fluid source. In some embodiments, the single fluid source is an infusion pump, and wherein the infusion pump is coupled to the first irrigation port and the second irrigation port via a Y-connector.

[0048] In some embodiments, the first irrigation port and the second irrigation port are connected to different fluid sources.

[0049] In some embodiments, the first irrigation port is directly coupled to the second section of the adapter proximal to the second irrigation port and distal to the suture locking assembly.

[0050] In some embodiments, the first irrigation port is part of the suture locking assembly and is disposed at a proximal end of the suture locking assembly.

[0051] In some embodiments, the delivery system further comprises a hemostatic seal disposed within a first section of the adapter proximal to the sleeve actuation handle, wherein the hemostatic seal comprises an opening that encircles a cut portion of a sleeve shaft of the sleeve actuation handle extending through the first section to the sleeve actuation handle, the hemostatic seal configured to seal around the cut portion of the sleeve shaft. In some embodiments, the delivery system further comprises a locking cap assembly disposed on the first section around the hemostatic seal, the locking cap assembly configured to apply inward pressure to the hemostatic seal and lock axial translation of the sleeve shaft relative to a remainder of the hub assembly.

[0052] In some embodiments, the push rod shaft is configured to deploy the docking device from the interior of the distal portion of the outer shaft upon reaching the native valve annulus and to arrange the docking device within the outer shaft during navigation of the delivery system to the native valve annulus, and the distal end of the sleeve shaft is spaced apart from the distal end of the outer shaft within the outer shaft.

[0053] In some embodiments, the docking device is configured to receive and secure the prosthetic heart valve at the native valve annulus.

[0054] In one representative embodiment, a method of delivering a docking device to a native valve of a heart can include: deploying the docking device from a distal end of a delivery system, the docking device being covered by a distal section of a sleeve shaft of the delivery system, the docking device including a coil extending along a central axis and including a central region having a plurality of turns, a leading turn extending from a first end of the central region, and a stabilizing turn extending from an opposite second end of the central region, wherein a covering extends around and along a top turn of the central region, the top turn being arranged at the second end of the central region; positioning the covered docking device at the native valve such that the covering of the top turn of the central region passes through and plugs a middle commissure of the native valve, at least a portion of the leading turn is positioned in a ventricle of the heart, and at least a portion of the stabilizing turn is positioned in an atrium of the heart; and after positioning the covered docking device, retracting the sleeve shaft in a proximal direction to uncover the docking device.

[0055] In some embodiments, deploying the docking device from the distal end of the delivery system includes pushing the covered docking device out of an outer shaft of the delivery system with a push rod shaft of the delivery system.

[0056] In some embodiments, retracting the sleeve shaft to uncover the docking device includes moving a sleeve actuation handle in a proximal direction.

[0057] In some embodiments, the method can further include maintaining a position of the push rod shaft while retracting the sleeve shaft to uncover the docking device, and after uncovering the docking device, retracting the push rod shaft into the outer shaft of the delivery system.

[0058] In some embodiments, the method can further include, during deployment of the covered docking device and positioning of the covered docking device at the native valve, flushing a plurality of lumens of the delivery system, the plurality of lumens including a first lumen arranged between the distal section of the sleeve shaft and the docking device and a second lumen arranged between the outer shaft of the delivery system and the sleeve shaft.

[0059] In some embodiments, flushing the first lumen includes: providing the flushing fluid to a push rod shaft lumen extending through a push rod shaft from a proximal end of the push rod shaft disposed within a branch section of the hub assembly to a distal end of the push rod shaft, wherein the suture lock is coupled to the branch section, to a distal end of the push rod shaft disposed proximate to but spaced apart from a proximal end of the docking device; and flowing the flushing fluid through the push rod shaft lumen and into and through the first lumen.

[0060] In some embodiments, the flushing fluid is provided to the push rod shaft lumen via a flushing port coupled to the branch section distally of the suture lock.

[0061] In some embodiments, the flushing fluid is provided to the push rod shaft lumen via a flushing port that is part of the suture lock and disposed at a proximal end of the suture lock.

[0062] In some embodiments, flushing the second lumen includes providing the flushing fluid to a first cavity formed between an outer surface of the push rod shaft and an inner surface of the passageway of the branch section, flowing the flushing fluid from the first cavity into a second cavity formed between an outer housing of the push rod shaft and a main tube of the push rod shaft, and flowing the flushing fluid from the second cavity to the second lumen.

[0063] In some embodiments, the method can further include disposing a distal tip of the distal section of the sleeve shaft to extend a distance beyond a distal end of the docking device in a distal direction during deployment and positioning of the covered docking device.

[0064] In some embodiments, the method can further include deploying the prosthetic heart valve inside a central region of the docking device.

[0065] In another representative embodiment, a method for providing a flushing fluid to a delivery system configured to deliver a docking device to a native valve of a heart can include: flowing the flushing fluid through an internal push rod shaft lumen extending through an internal push rod shaft to a distal end of the internal push rod shaft, wherein the push rod shaft is disposed coaxially with and at least partially within a sleeve shaft of the delivery system, the sleeve shaft and the push rod shaft are disposed within an outer shaft of the delivery system, the outer shaft extending distally from a handle assembly of the delivery system, the sleeve shaft including a distal section that surrounds and covers a distal section of the docking device; flowing the flushing fluid from the push rod shaft lumen into a sleeve shaft lumen formed between an outer surface of the docking device and an inner surface of the distal section of the sleeve shaft; and flowing the flushing fluid through a delivery shaft lumen formed between an outer surface of the sleeve shaft and an inner surface of the outer shaft.

[0066] In some embodiments, flowing the flushing fluid through the pusher shaft lumen and into the sleeve shaft lumen and through the delivery shaft lumen includes continuously flowing the flushing fluid from a common fluid source to the pusher shaft lumen, the sleeve shaft lumen, and the delivery shaft lumen.

[0067] In some embodiments, flowing the flushing fluid through the pusher shaft lumen and into the sleeve shaft lumen and through the delivery shaft lumen includes continuously flowing the flushing fluid from a first fluid source to the pusher shaft lumen and the sleeve shaft lumen and continuously flowing the flushing fluid from a separate second fluid source to the delivery shaft lumen.

[0068] In some embodiments, flowing the flushing fluid through the pusher shaft lumen and into the sleeve shaft lumen and through the delivery shaft lumen occurs during advancing a distal portion of the delivery system to a native valve and positioning a docking device covered by the sleeve shaft at the native valve, wherein the distal portion of the delivery system includes the docking device disposed therein.

[0069] In some embodiments, flowing the flushing fluid through the pusher shaft lumen and into the sleeve shaft lumen and through the delivery shaft lumen occurs prior to inserting the delivery device into a patient, during preparing the delivery device for an implantation procedure.

[0070] In some embodiments, flowing the flushing fluid through the delivery shaft lumen includes flowing the flushing fluid from a first flushing port coupled to the passage of the hub assembly of the delivery system to a first cavity formed between an outer surface of the pusher shaft and an inner surface of the passage, flowing the flushing fluid from the first cavity into a second cavity disposed between an inner surface of the outer housing of the pusher shaft and an outer surface of the main tube of the pusher shaft, and flowing the flushing fluid from the second cavity to the delivery shaft lumen.

[0071] In some embodiments, flowing the flushing fluid through the delivery shaft lumen includes flowing the flushing fluid from the first flushing port coupled to the passage and in direct fluid communication with the first cavity into the first cavity.

[0072] In some embodiments, flowing the flushing fluid through the pusher shaft lumen and into the sleeve shaft lumen includes flowing the flushing fluid from a second flushing port into the pusher shaft lumen, the second flushing port coupled to the passage proximally of a location at which the first flushing port is coupled to the passage and in direct fluid communication with the pusher shaft lumen.

[0073] In some embodiments, the method can further include maintaining the flow of flushing fluid from the first flushing port into the first cavity separate from the flow of flushing fluid from the second flushing port into the pusher shaft lumen.

[0074] In some embodiments, a docking device for docking a prosthetic valve at a native heart valve includes a coil extending along a central axis, the coil including a leading coil, a central region, and a stabilizing coil, wherein the central region has a plurality of turns having substantially equal inner diameters, the leading turns extend from one end of the central region and have a diameter greater than the diameter of the central region, and the stabilizing turns have a diameter greater than the diameter of the central region and extend from the leading turns from an opposite end of the central region.

[0075] In some embodiments of the docking device, the stabilizing turns are designed to form three points of contact in the native anatomy.

[0076] In some embodiments of the docking device, the stabilizing turns are designed to seat in a position lower than the central region in free space, thereby lifting the central region.

[0077] In some embodiments of the docking device, the stabilizing turns have a diameter greater than the diameter of the opening of the native mitral valve, but small enough to rest on the mitral valve plane.

[0078] In some embodiments of the docking device, the stabilizing turns are configured to form a loop around a deployed prosthetic valve.

[0079] In some embodiments of the docking device, the central region has at least three complete turns.

[0080] In some embodiments of the docking device, the stabilizing turns have a covering to form a seal against the prosthetic valve.

[0081] In some embodiments of the docking device, the covering is and / or includes a foam.

[0082] In some embodiments of the docking device, the covering is and / or includes a woven structure, such as a nitinol woven structure and / or a covered nitinol woven structure (e.g., covered in cloth, fabric, polymer, foam, etc.).

[0083] In some embodiments of the docking device, the covering has holes sized to be non-traumatic to the native tissue and allow tissue ingrowth into the covering.

[0084] In some embodiments of the docking device, the docking device further includes a soft covering over the entire length of the coil to reduce friction and maintain retention for the prosthetic valve.

[0085] In some embodiments of the docking device, the soft covering includes multiple layers of ePTFE bonded together.

[0086] In some embodiments of the docking device, the bonding is intermittent to increase the tackiness of the soft covering.

[0087] In some embodiments of the docking device, the central region form includes at least 3 turns, including a proximal turn, a distal turn, and at least 1 intermediate turn, wherein the proximal turn is the turn closest to the stabilizing turn, and the distal turn is the turn closest to the guiding turn, and wherein the central region forms a generally hourglass structure, wherein the diameter of the distal turn and the proximal turn is greater than the diameter of the at least 1 intermediate turn.

[0088] In some embodiments of the docking device, the central region form includes at least 3 turns, including a proximal turn, a distal turn, and at least 1 intermediate turn, wherein the proximal turn is the turn closest to the stabilizing turn, and the distal turn is the turn closest to the guiding turn, and wherein the central region forms a generally hourglass structure, wherein the diameter of the distal turn and the proximal turn is greater than the diameter of the at least 1 intermediate turn.

[0089] In some embodiments of the docking device, the docking device includes a flange formed by joining the stabilizing turn with the next adjacent turn in the central region using a cloth.

[0090] In some embodiments of the docking device, the coil includes a radiopaque marker.

[0091] In some embodiments of the docking device, the radiopaque marker is located at a quarter turn around the guiding turn.

[0092] In some embodiments, an implantable prosthetic heart valve includes an annular frame having an inflow end and an outflow end and being radially collapsible and expandable between a radially collapsed configuration and a radially expanded configuration, the frame defining an axial direction extending from the inflow end to the outflow end; a leaflet structure positioned within and secured to the frame; and a flange attached to the inflow end of the annular frame and designed to extend outwardly therefrom.

[0093] In some embodiments, the implantable prosthetic heart valve has a flange composed of and / or including a memory material (e.g., a shape memory alloy, a shape memory metal, nitinol, etc.).

[0094] In one embodiment of the implantable prosthetic heart valve, the flange is made of and / or includes nitinol.

[0095] In some embodiments of the implantable prosthetic heart valve, the flange is attached to the annular frame by a cloth interposer.

[0096] In some embodiments of the implantable prosthetic heart valve, the implantable prosthetic heart valve further includes a skirt attached to an outer surface of the annular frame.

[0097] In some embodiments of the implantable prosthetic heart valve, the skirt is composed of and / or includes at least one of a foam and a cloth.

[0098] In some embodiments of the implantable prosthetic heart valve, the foam is at least one selected from the group consisting of polyurethane and polyurethane-poly carbonate matrix.

[0099] In some embodiments of the implantable prosthetic heart valve, the skirt is expandable.

[0100] In some embodiments of the implantable prosthetic heart valve, the skirt comprises both cloth and foam.

[0101] In some embodiments of the implantable prosthetic heart valve, the annular frame comprises a memory material that combines with or is positioned under the skirt to assist in expansion of the skirt, which is made of cloth and foam.

[0102] In some embodiments of the implantable prosthetic heart valve, the skirt has a larger diameter near the inflow end of the prosthetic valve than near the outflow end of the prosthetic valve.

[0103] In some embodiments of the implantable prosthetic heart valve, the skirt has a pocket for placement of embolic material.

[0104] In some embodiments of the implantable prosthetic heart valve, the pocket has an aperture to allow insertion of embolic material.

[0105] In some embodiments of the implantable prosthetic heart valve, the pocket has a permeable or semi-permeable covering to allow fluid exchange between the embolic material and native blood.

[0106] In some embodiments of the implantable prosthetic heart valve, the embolic material is selected from the group consisting of hydrogel, ethylene-vinyl alcohol dissolved in dimethyl sulfoxide, and n-butyl cyanoacrylate.

[0107] In some embodiments, a system for implanting a docking device at a native valve includes a delivery catheter, an elongated coiled docking device having an end portion, a push rod shaft disposed in the delivery catheter and coupled to the end portion of the coiled docking device, and a sleeve shaft coaxially positioned with the push rod shaft and disposed between the delivery catheter and the push rod shaft, wherein the system is configured such that the push rod shaft and the sleeve shaft operate in parallel.

[0108] In some embodiments of the system for implanting a docking device at a native valve, the sleeve shaft includes a distal section, an intermediate section, and a proximal section, wherein the distal section forms a lubricating sleeve that covers the docking device, and the proximal section is used to actuate the position of the lubricating sleeve.

[0109] In some embodiments of the system for implanting a docking device at a native valve, the lubricating sleeve is and / or comprises a low-friction material.

[0110] In some embodiments of the system for implanting a docking device at a native valve, the lubricating sleeve has a hydrophilic coating.

[0111] In some embodiments of the system for implanting a docking device at a native valve, the lubricating sleeve has a hydrogel coating.

[0112] In some embodiments of the system for implanting a docking device at a native valve, the proximal section is rigid and has a cutout to allow access to the push rod shaft.

[0113] In some embodiments of the system for implanting a docking device at a native valve, the distal section and the intermediate section are flexible and each is constructed from a polymer and a woven structure.

[0114] In some embodiments of the system for implanting a docking device at a native valve, the polymer is and / or includes a polyether-amide block copolymer or a blend of two or more polyether-amide block copolymers.

[0115] In some embodiments of the system for implanting a docking device at a native valve, the woven is and / or includes stainless steel.

[0116] In some embodiments of the system for implanting a docking device at a native valve, the distal section has a high density woven.

[0117] In some embodiments of the system for implanting a docking device at a native valve, the intermediate section has a lower density woven than the distal section.

[0118] In some embodiments of the system for implanting a docking device at a native valve, the push rod shaft includes a main hypotube having a distal end affixed to the docking device and a proximal end opposite the distal end, a housing, a plug, and a proximal extension at which the housing extends coaxially with the main hypotube and the sleeve shaft, the proximal extension being welded to the proximal end of the main hypotube using the plug, and the proximal extension being disposed between the catheter and the sleeve shaft, and wherein the proximal extension extends from the proximal end of the main hypotube.

[0119] In some embodiments of the system for implanting a docking device at a native valve, the proximal extension is constructed from a flexible material.

[0120] In some embodiments of the system for implanting a docking device at a native valve, the housing and the plug are welded to the main hypotube to allow the cutout portion of the sleeve shaft to slide between the main hypotube and the housing.

[0121] In some embodiments of the system for implanting a docking device at a native valve, the system for implanting a docking device at a native valve further includes a handle assembly.

[0122] In some embodiments of the system for implanting a docking device at a native valve, the handle assembly includes a generally Y-shaped connector.

[0123] In some embodiments of the system for implanting a docking device at a native valve, the Y-shaped connector has a branch and a straight section, wherein the sleeve shaft extends to an end of the straight section and the proximal extension extends to the branch.

[0124] In some embodiments of the system for implanting a docking device at a native valve, the handle assembly further includes an irrigation port.

[0125] In some embodiments of the system for implanting a docking device at a native valve, the irrigation port is configured such that a plurality of lumens formed between the catheter, the sleeve shaft, and the pushrod shaft can be simultaneously irrigated from a single port.

[0126] In some embodiments of the system for implanting a docking device at a native valve, the handle assembly includes a hemostatic seal located in the formed straight portion and having a first end located proximate an opening of the sleeve shaft shape.

[0127] In some embodiments of the system for implanting a docking device at a native valve, the sleeve shaft has a laser cut portion forming a generally U-shaped structure and the opening has a U-shaped shape.

[0128] In some embodiments of the system for implanting a docking device at a native valve, the handle assembly further includes a first rigid grommet located on one end of the hemostatic seal and a second rigid grommet located on a second end of the hemostatic seal.

[0129] In some embodiments of the system for implanting a docking device at a native valve, the first and second rigid grommets apply pressure inward on the hemostatic seal to form a seal between the hemostatic seal and the sleeve shaft.

[0130] In some embodiments of the system for implanting a docking device at a native valve, the handle assembly further includes a locking cap assembly.

[0131] In some embodiments of the system for implanting a docking device at a native valve, the locking cap assembly allows for adjustment of the inward pressure between the first and second rigid grommets and the hemostatic seal to secure the sleeve shaft.

[0132] The present disclosure provides methods for delivering an implant to a native valve of a heart. The methods can be used to deliver any of the implants described herein, including the docking devices described herein. In some embodiments, the methods can include positioning a selected docking device at a native valve of a heart such that at least a portion of a leading turn of the docking device is positioned in a ventricle of the heart and around one or more leaflets of the native valve. In certain embodiments, implantation of the docking device can be used to reshape one or more tissues in the heart to repair the function of the native valve. In some embodiments, the methods can include delivering a docking device to a native mitral valve to repair the left ventricle and associated heart function. In some embodiments, the methods can reduce the annulus diameter and apply tension on the chordae. In some embodiments, the methods can further include performing an edge-to-edge repair of native leaflets of the native mitral valve, such as by attaching a clip to attach a free edge of an anterior mitral leaflet to a free edge of a posterior mitral leaflet.

[0133] In some embodiments, the methods can include delivering an implantable prosthetic heart valve within the docking device after positioning the docking device at a desired location at a native valve of a heart. The methods can be used to deliver any of the implantable prosthetic heart valves described herein. In some embodiments, a suitable implantable prosthetic heart valve that can be used in the methods can have a ring-shaped frame having an inflow end and an outflow end that are radially collapsible and expandable between a radially collapsed configuration and a radially expanded configuration, the frame defining an axial direction extending from the inflow end to the outflow end; a leaflet structure positioned within the frame and secured thereto; and a flange attached to the inflow end of the ring-shaped frame and designed to extend outwardly therefrom. In certain embodiments, the methods can further include positioning the implantable prosthetic heart valve in the radially collapsed configuration within the docking device, and expanding the implantable prosthetic heart valve from the radially collapsed configuration to the radially expanded configuration such that a radially outward pressure is applied by the frame of the implantable prosthetic heart valve onto at least a portion of the central region of the docking device.

[0134] In some aspects, the present disclosure further provides methods of delivering an implant using the delivery systems described elsewhere herein. In certain embodiments, a delivery system suitable for use in the methods can include a delivery catheter; a docking device having end portions at end portions of a stabilizing turn positioned opposite the central region; a push rod shaft disposed in the delivery catheter and coupled to the end portions of the docking device; and a sleeve shaft coaxially positioned with the push rod shaft and disposed between the delivery catheter and the push rod shaft. In some embodiments, the delivery system can be configured such that the push rod shaft and the sleeve shaft operate in parallel. In certain embodiments, the positioning step of the methods can include pushing the docking device out of the catheter with the push rod shaft.

[0135] In various embodiments, the method can be performed on a living animal or on an inanimate cadaver, a cadaveric heart, a simulator (e.g., a simulated body part, tissue, etc.), a humanoid avatar, etc.

[0136] The foregoing and other objects, features and advantages of the disclosed technology will become more apparent from the following detailed description, which proceeds with reference to the accompanying drawings. BRIEF DESCRIPTION OF DRAWINGS

[0137] FIG. 1 A schematic cross-sectional view of a human heart is shown in accordance with various embodiments.

[0138] FIG. 2 A schematic top view of the mitral annulus of a heart is shown in accordance with various embodiments.

[0139] FIG. 3A A perspective view of an embodiment of a prosthetic heart valve with a flange is shown in accordance with various embodiments.

[0140] FIG. 3B A side view of an embodiment of a prosthetic heart valve with a flange is shown in accordance with various embodiments.

[0141] FIG. 3C A perspective view of an example embodiment of a prosthetic heart valve with commissure flanges is shown in accordance with various embodiments.

[0142] FIG. 4A-FIG. 4C A view of an example embodiment of a prosthetic heart valve with a covering is shown in accordance with various embodiments.

[0143] FIG. 5A-FIG. 5F A view of an example embodiment of a prosthetic heart valve with a sculpted covering is shown in accordance with various embodiments.

[0144] FIG. 6A A side view of an embodiment of a prosthetic heart valve with a woven cloth covering is shown in accordance with various embodiments.

[0145] FIG. 6B A side view of an embodiment of a prosthetic heart valve with a hybrid covering is shown in accordance with various embodiments.

[0146] FIG. 6C-FIG. 6E A view of an embodiment of a prosthetic heart valve with an edge covering is shown in accordance with various embodiments.

[0147] FIG. 7A-FIG. 7C A view of a prosthetic heart valve with a flexible flange support is shown in accordance with various embodiments.

[0148] FIG. 8 A prosthetic heart valve with outward struts is shown in accordance with various embodiments.

[0149] FIG. 9A A top view of an example embodiment of a docking device or core of a docking device having three points of contact in the left atrium is shown, in accordance with various embodiments.

[0150] FIG. 9B and FIG. 9C A side view of an example embodiment of a docking device or core of a docking device having three points of contact in the left atrium is shown, in accordance with various embodiments.

[0151] FIG. 10A and FIG. 10B A top view of an example embodiment of a docking device having a flattened stabilizing or atrial turn is shown, in accordance with various embodiments.

[0152] FIG. 10C and FIG. 10D A side view of an example embodiment of a docking device or core of a docking device having a flattened stabilizing or atrial turn is shown, in accordance with various embodiments.

[0153] FIG. 11A A top view of an example embodiment of a hybrid docking device or core of a hybrid docking device is shown, in accordance with various embodiments.

[0154] FIG. 11B and FIG. 11C A side view of an example embodiment of a hybrid docking device or core of a hybrid docking device is shown, in accordance with various embodiments.

[0155] FIG. 12A-FIG. 12D A top view of an example embodiment of a docking device having a covering over a stabilizing or atrial turn is shown, in accordance with various embodiments.

[0156] FIG. 12E A perspective view of an example embodiment of a docking device having a covering over a functional turn is shown, in accordance with various embodiments.

[0157] FIG. 12F A cross-sectional view of a first portion of a covering of a docking device of FIG. 12E , in accordance with various embodiments.

[0158] FIG. 12G A cross-sectional view of a second portion of a covering of a docking device of FIG. 12E , in accordance with various embodiments.

[0159] FIG. 12H A top view or plan view of a mitral valve with leaflets closed and coapted and indicating major anatomical landmarks and indicating chart lines of features of a docking device of FIG. 12E , in accordance with various embodiments.

[0160] FIG. 13A A schematic diagram showing an example embodiment of a docking device with a cover is shown, in accordance with various embodiments.

[0161] FIG. 13B-FIG. 13C A cross-sectional view showing an example embodiment of a docking device with a cover is shown, in accordance with various embodiments.

[0162] FIG. 14A And FIG. 14B A cross-sectional view showing an example embodiment of a docking device with a soft cover is shown, in accordance with various embodiments.

[0163] FIG. 14C An elongated linear view with a schematic diagram showing a soft cover, in accordance with various embodiments.

[0164] FIG. 15A And FIG. 15B A side view showing an example embodiment of a docking device with an hourglass shape in the central region, in accordance with various embodiments.

[0165] FIG. 15C And FIG. 15D A side view showing an example embodiment of a docking device with a barrel shape in the central region, in accordance with various embodiments.

[0166] FIG. 16 A perspective view showing an example embodiment of a docking device with a flange at the stable or atrial turn, in accordance with various embodiments.

[0167] FIG. 17A An example embodiment of a sleeve shaft is shown, in accordance with various embodiments.

[0168] FIG. 17B A side cross-sectional view of the sleeve shaft of FIG. 17A is shown.

[0169] FIG. 17C A detail view of a portion of the sleeve shaft of FIG. 17B is shown, showing an interface between different materials of the sleeve shaft.

[0170] FIG. 17D A side view showing an example embodiment of a flexible polymer jacket of the sleeve shaft of FIG. 17B is shown.

[0171] FIG. 17E A side view showing an example embodiment of a more rigid tube portion of the sleeve shaft of FIG. 17B is shown.

[0172] FIG. 18 An example embodiment of a layered construction of a lubricating sleeve is shown, in accordance with various embodiments.

[0173] FIG. 19 a side view cross-section of an example embodiment of a flexible tip of a sleeve shaft is shown. FIG. 17B

[0174] FIG. 20A a side view of an example embodiment of a proximal section of a sleeve shaft is shown, in accordance with various embodiments.

[0175] FIG. 20B a perspective view of an example embodiment of a more rigid tube portion of a proximal section of a sleeve shaft is shown, in accordance with various embodiments.

[0176] FIG. 20C a perspective view of an example embodiment of an interface between a tube portion of a sleeve shaft and an inner liner at a proximal section of the sleeve shaft is shown, in accordance with various embodiments. FIG. 20B

[0177] FIG. 20D a perspective view of an example embodiment of an outer flexible polymer layer disposed on a tube portion and an inner liner at a proximal section of a sleeve shaft is shown, in accordance with various embodiments. FIG. 20C

[0178] FIG. 21A a first side view cross-section of an example embodiment of a push rod shaft is shown, in accordance with various embodiments.

[0179] FIG. 21B a second side view cross-section of an example embodiment of a push rod shaft is shown, in accordance with various embodiments.

[0180] FIG. 21C a detail view of a distal end of a push rod shaft is shown. FIG. 21B

[0181] a proximal end view of a push rod shaft is shown. FIG. 21D FIG. 21B a side view of a tube portion of a push rod shaft is shown.

[0182] FIG. 21E FIG. 21B a side view of a housing of a push rod shaft is shown.

[0183] FIG. 21F an end view of a plug of a push rod shaft is shown. FIG. 21B

[0184] an example embodiment of a sleeve shaft and a push rod shaft that cooperate with one another is shown, in accordance with various embodiments. FIG. 21G FIG. 21B

[0185] FIG. 22A-FIG. 22C

[0186] FIG. 23A ​​​​​​​​A side view of an example embodiment of a proximal extension of a push rod shaft is shown in accordance with various embodiments.

[0187] FIG. 23B A perspective view of a push rod shaft including a proximal extension of FIG. 23A is shown.

[0188] FIG. 24A A portion of a handle assembly of a delivery system for a docking device is shown in accordance with example embodiments.

[0189] FIG. 24B An example embodiment of a delivery system for a docking device is shown.

[0190] FIG. 25 An example embodiment of an irrigation plate is shown in accordance with various embodiments.

[0191] FIG. 26A and FIG. 26B An example embodiment of a hemostatic seal is shown in accordance with various embodiments.

[0192] FIG. 27A An example embodiment of a portion of a handle assembly for a delivery system including a suture lock and a sleeve handle is shown in accordance with various embodiments.

[0193] FIG. 27B A perspective view of a suture lock of FIG. 27A disconnected from a branch of a handle assembly is shown.

[0194] FIG. 27C An exploded view of a suture lock of FIG. 27A is shown.

[0195] FIG. 28A A side view of an embodiment of a suture lock of FIG. 27A-FIG. 27C including an irrigation port at a proximal end of the suture lock is shown.

[0196] FIG. 28B A perspective view of a detail portion of a suture lock of FIG. 27A-FIG. 27C showing a release knob and an internal release lever.

[0197] FIG. 28C A side cutaway view of a release lever of a suture lock of FIG. 28B is shown.

[0198] FIG. 28D A perspective view of a release lever of FIG. 28B and FIG. 28C is shown.

[0199] FIG. 28E A perspective view of a release lever of FIG. 28B-FIG. 28DA detailed cross-sectional view of the suture cut section of the release lever.

[0200] FIG. 29A-FIG. 29E Example embodiments of an orientation mechanism for a suture locking member, according to various embodiments, are shown.

[0201] FIG. 30A-FIG. 30C Example embodiments of a suture cutting and removal mechanism according to various embodiments are shown.

[0202] FIG. 31A and FIG. 31B Example embodiments of a coil holder according to various embodiments are shown.

[0203] FIG. 32A-FIG. 32C Methods for expanding a cover on a docking device according to various embodiments are shown.

[0204] FIG. 33 A perspective view of an example embodiment of a sleeve shaft is shown, which covers the docking device and extends to the outside of the delivery conduit of the delivery system.

[0205] FIG. 34 It shows that from FIG. 33 The delivery system deploys the docking device and removes the sleeve shaft from the docking device, then surrounds the push rod shaft with the sleeve shaft.

[0206] FIG. 35 A side sectional view of a portion of the handle assembly and the fluid flow through the lumen of the handle assembly are shown.

[0207] FIG. 36 It shows FIG. 35 A more detailed perspective sectional view of the handle assembly and the fluid flow through the lumen of the handle assembly.

[0208] FIG. 37 A perspective sectional view of a portion of a delivery system is shown, which includes push rod shafts and sleeve shafts arranged coaxially with each other, and fluid flow through lumens arranged between the coaxial members.

[0209] FIG. 38 A schematic diagram of fluid flow through a lumen in the distal portion of a delivery system is shown, the delivery system including a push rod shaft, a sleeve shaft, and a docking device arranged in the outer shaft of the delivery system.

[0210] FIG. 39 This is a flowchart of a method for delivering a docking device to a natural heart valve and implanting the docking device and an associated artificial heart valve at the natural valve. Detailed Implementation

[0211] Disclosed herein are various systems, devices, methods, etc. that include anchoring or docking devices that can be used in conjunction with expandable prosthetic valves (e.g., transcatheter heart valves (THVs)) at native valve annuli (e.g., mitral or tricuspid annuli) in order to more safely implant and secure the prosthetic valves at the implant site. The anchoring / docking devices according to embodiments of the present application provide or form a more circular and / or more stable anchoring site, landing zone, or implant zone at the implant site in which the prosthetic valve can be expanded or otherwise implanted. Many of these docking devices and prosthetic valves have circular or cylindrical valve frames or stents that can be expanded or otherwise implanted into locations having a naturally circular cross-section. However, other embodiments of the docking devices and prosthetic valves have other geometries (e.g., elliptical, ovoid, longitudinally curved, etc.) that are better suited for non-circular and / or non-cylindrical anatomical structures. In addition to providing an anchoring site for the prosthetic valve, the anchoring / docking devices can be sized and shaped to cinch or pull radially inward on the native valve (e.g., mitral, tricuspid, etc.). In this manner, one of the primary causes of valve regurgitation (e.g., functional mitral regurgitation) (especially heart (e.g., left ventricular enlargement, etc.) and / or annular enlargement and subsequent prolapse from the native valve (e.g., mitral, etc.)) can be at least partially compensated for or counteracted. Some embodiments of the anchoring or docking devices further include features that are shaped and / or modified, for example, to better maintain the position or shape of the docking device during and / or after expansion of the prosthetic valve therein. By providing such anchoring or docking devices, replacement valves can be more safely implanted and maintained at various valve annuli, including at mitral annuli that do not have a naturally circular cross-section.

[0212] Reference is first made to FIG. 1 and 2 The mitral valve 10 controls the flow of blood between the left atrium 12 and the left ventricle 14 of the human heart. After the left atrium 12 receives oxygenated blood from the lungs via the pulmonary veins, the mitral valve 10 allows the oxygenated blood to flow from the left atrium 12 into the left ventricle 14. When the left ventricle 14 contracts, the oxygenated blood that remains in the left ventricle 14 is delivered to the rest of the body through the aortic valve 16 and the aorta 18. At the same time, the mitral valve should close during ventricular contraction to prevent any backflow of blood into the left atrium.

[0213] When the left ventricle contracts, the blood pressure in the left ventricle rises significantly, which serves to urge the mitral valve to close. Because of the large pressure differential between the left ventricle and the left atrium during this time, a great deal of pressure is exerted on the mitral valve, leading to the possibility of the mitral valve leaflets prolapsing or evertin back into the atrium. Thus, a series of chordae 22 connect the mitral valve leaflets to the papillary muscles located on the left ventricular wall, where the chordae and papillary muscles are both taut during ventricular contraction to hold the leaflets in the closed position and prevent them from extending back into the left atrium. This helps to prevent the backflow of oxygenated blood into the left atrium. In FIG. 1 cross-sectional view of a heart and FIG. 2 a top view of a mitral valve, the chordae 22 are shown schematically.

[0214] The overall shape of the mitral valve and its leaflets, as viewed from the left atrium, is shown in FIG. 2 . The commissure 24 is at the end where the anterior leaflet 26 and posterior leaflet 28 of the mitral valve 10 come together. Various complications of the mitral valve can potentially lead to fatal heart failure. One form of valvular heart disease is mitral valve leakage or mitral regurgitation, which is characterized by the abnormal leakage of blood from the left ventricle through the mitral valve back into the left atrium. This can be caused, for example, by left ventricular dilation causing the native mitral valve leaflets to not fully coapt, by damage to the native leaflets, or by weakening (or destruction) of the chordae and / or papillary muscle tendons. In these cases, it can be necessary to repair the mitral valve or replace the function of the mitral valve with a prosthetic heart valve.

[0215] The field of transcatheter aortic valve replacement has developed more and achieved wider success than transcatheter mitral valve replacement. This difference is due in part to the fact that replacement of the mitral valve is more difficult in many ways than replacement of the aortic valve, such as, for example, due to the non-circular physical structure of the mitral valve, the subvalvular anatomy and the difficulty of accessing the valve. In addition, the mitral valve often lacks calcification, limiting the ability of the prosthetic valve to anchor within the mitral valve.

[0216] One of the most prominent obstacles to mitral valve replacement is effectively anchoring or holding the valve at the location of the mitral valve due to the large cyclic loads that the valve is subjected to. Another problem with mitral valve replacement, as noted above, is the size and shape of the native mitral annulus, as shown in FIG. 2The aortic valve is more rounded or more cylindrical than the mitral valve. Also, both the mitral and tricuspid valves are larger and more elongated in shape than the aortic valve, making them more difficult and non- routine sites for implanting replacement valves having a generally round or cylindrical valve frame. If a good seal around the valve is not established, a circular artificial valve that is too small can result in leakage around the implant (i.e., paravalvular leakage), while a circular artificial valve that is too large can cause the narrower portion of the native mitral annulus to stretch and damage. Moreover, in many cases, the need for aortic valve replacement arises due to, for example, aortic valve stenosis, in which the aortic valve is narrowed due to calcification or other hardening of the native leaflets. Thus, the aortic annulus generally forms a tighter, stiffer, and more stable anchoring site for an artificial valve than the mitral annulus, which is both larger and non- circular compared to the aortic annulus. The case of mitral regurgitation is unlikely to provide such a good anchoring site. Also, the presence of chordae tendineae and other anatomical structures at the mitral valve location can create obstacles that make it more challenging to anchor a device sufficiently at the mitral valve location.

[0217] Other obstacles to effective replacement of the mitral valve can arise from the relatively large circulatory load borne by the mitral valve, and the need to establish a sufficiently strong and stable anchoring and retention. Also, even a slight shift in alignment of the valve can still result in blood flow through the valve or other portions of the heart that are obstructed or otherwise negatively affected.

[0218] Embodiments of prosthetic valves

[0219] A prosthetic valve according to an example embodiment is shown in FIG. 3A to FIG. 6B The general structure, methods of manufacture, and methods of use of various prosthetic heart valves that can be adapted for use with the anchoring / docking devices herein are described at least in U.S. Patent No. 10,195,025 entitled “Prosthetic Heart Valve”; U.S. Patent Publication No. US 2018 / 0206982 entitled “Covered Prosthetic Heart Valve”; and U.S. Patent Application No. 16 / 252,890 entitled “Covered Prosthetic Heart Valve”, the disclosure of each of the above-mentioned patent documents is incorporated herein by reference in its entirety.

[0220] FIG. 3A and FIG. 3BAn example prosthetic valve 30 having a flange 32 is shown that is attached to the atrial (inflow end) 34 of the prosthetic valve 30 and extends radially outward 360°. In many of these embodiments, the flange 32 is designed to rest on the plane of the native valve, such as the plane of the native mitral valve, tricuspid valve, etc. The flange 32 of some embodiments is designed to facilitate flow through the prosthetic valve 30 to prevent and / or reduce paravalvular leakage. FIG. 3C A prosthetic valve 30 is shown that includes flanges 32 and 32' designed to cover only the commissures of the mitral valve rather than covering the entire plane of the mitral valve. Flanges 32 and 32' that cover only the commissures can advantageously reduce the crimped or compressed size of the valve for a narrower profile during delivery, but can require repositioning or adjustment of the prosthetic valve 30 during deployment. In various embodiments, the flange 32 (or flanges 32 and 32') is made of a resilient material that can be crimped onto a catheter for delivery. In certain embodiments, the flange 32 (or flanges 32 and 32') is made of and / or includes a memory material that can be compressed or manipulated and return to a particular shape once the force is removed. One example of a memory material is Nitinol (or NiTi), but other shape memory alloys or shape memory metals can also be used. The memory material can be formed as a braid or frame that can be compressible and return to its formed shape (e.g., flange) once released from the catheter. In some embodiments, the flange 32 is attached to the frame of the prosthetic valve via a cloth intermediary 36.

[0221] Turning to FIG. 4A to FIG. 4B , an example embodiment of a prosthetic valve 40 is shown that includes a covering 42 (such as a skirt) on the outer surface of the prosthetic valve 40. In covered embodiments, the covering can be designed and / or configured to prevent paravalvular leakage between the prosthetic valve 40 and the native valve, to protect the native anatomy, to facilitate tissue ingrowth, and / or designed / configured for other purposes. Due to the generally D-shaped form of the mitral valve (see FIG. 2 ) and the relatively large annulus compared to the aortic valve, the covering 42 acts as a seal around the prosthetic valve 40 (e.g., when the size of the valve is designed to be smaller than the size of the annulus) and allows the native leaflets to glideably engage with the prosthetic valve 40. In various embodiments, the covering 42 is constructed of a material that can be crimped for transcatheter delivery of the prosthetic valve and expandable to prevent paravalvular leakage around the prosthetic valve. Examples of possible materials include foam, cloth, fabric, one or more polymers, and / or encapsulated materials such as encapsulated hydrogels. In certain embodiments, as shown in FIG. 4, the covering 42 is attached to the frame of the prosthetic valve 40 via a cloth intermediary 44. FIG. 4AAs shown, the cover is attached via loop-over-stitching 63, while other embodiments will utilize edge cover strips 65 with radial, horizontal stitching, as shown. FIG. 4B The edge cover strips 65 of many embodiments are constructed of any suitable material that is biocompatible and non-traumatic to native tissue, including: ePTFE, bovine pericardium, porcine pericardium, equine pericardium, woven PTFE (polytetrafluoroethylene), knitted PTFE, braided PTFE, polyurethane, electrospun ePTFE, impregnated thermoplastic, sprayed thermoplastic, other organic tissue, other non-organic tissue, and combinations thereof.

[0222] Turning to FIG. 4C The cover solution of some embodiments (e.g., in cloth, fabric, etc.) will form a pocket 46, such as a cup or a purse shape, to allow for the insertion, injection, or encapsulation of embolic material after the valve is placed, and to allow for free fluid exchange with native blood. Certain embodiments that include a pocket include one or more holes 44 in the layer of the cover to allow the outer layer to inflate during heart contraction. In some embodiments, the encapsulated material can provide an attractive inflation mechanism. Certain embodiments inflate by receiving blood from the atrial side of the prosthetic valve. In additional embodiments, the holes 44 or ports allow for the insertion of embolic material with limited exposure to native blood, while further embodiments fully or nearly fully encapsulate the embolic material. In some encapsulated embodiments, the skirt can have a permeable or semi-permeable cover to allow for fluid exchange between the encapsulated material and blood. In some embodiments, the embolic material is injected through a catheter or syringe. Further embodiments use monofilament warping and / or buckling to expand the pocket. Reference is made herein to FIG. 8 Examples of monofilament warping are further discussed.

[0223] In many embodiments, the embolic material will be a hydrogel. Some hydrogels expand at body temperature; thus, selecting a body temperature expandable hydrogel allows the patient's natural heat to provide expansion of the hydrogel around the prosthetic valve, thereby preventing paravalvular leakage. Further embodiments will have a hydrogel that expands by absorbing fluid, such as blood. In such embodiments, the hydrogel can be inserted into the skirt prior to valve deployment, and the presence of blood after deployment will allow the hydrogel to expand. Additional embodiments will utilize a precipitating composition, such as ethylene vinyl alcohol (EVOH) dissolved in dimethyl sulfoxide (DMSO). Certain EVOH-DMSO compositions are known in the art, including LIQUID EMBOLIC SYSTEM TM ( Micro Therapeutics, Inc., Irvine, CA, USA) formulation 18 (6% EVOH), 34 (8% EVOH), HD-500 (20% EVOH) or blends thereof. In such embodiments, the EVOH-DMSO composition is inserted into the skirt after or during valve deployment. The DMSO in these compositions will be carried away by the blood, leaving the EVOH, which forms a plug to prevent paravalvular leakage.

[0224] In certain embodiments, the embolic material can be n-butyl cyanoacrylate. Some suitable embolic materials can be liquid alkyl-2-cyanoacrylate monomers that form flexible polymers that can form a bond with soft tissue when contacted with ionic media (e.g., water / blood). These isolated liquid monomers are non-tacky, radiolucent, and can polymerize rapidly. In certain embodiments, the embolic material can be a multi-component formulation including cyanoacrylate and a radiopaque material, ethiodized oil, or both. In some embodiments, the additional component can extend the polymerization time, make the liquid opaque, and allow visualization under fluoroscopy. Certain n-butyl cyanoacrylates are known in the art, including n-Butyl-2-cyanoacrylate liquid embolic system (DePuy Synthes, Raynham, MA, USA).

[0225] In further embodiments, the embolic material can include one or more radiopaque materials that provide visualization under fluoroscopy. In certain embodiments, the radiopaque material can comprise one or more salts, compounds, or nanoparticles containing iodine, barium, tantalum, bismuth, or gold. In some embodiments, the radiopaque material can be tantalum powder.

[0226] Embodiments comprising a foamed solution provide a covering that is attached to the exterior of the valve frame in order to provide a substantial amount of paravalvular leak solution while maintaining a low crimped profile, enabling the device to be delivered via a catheter. In certain embodiments, one or more foamed materials can be used to achieve a low device profile when crimped and provide for expansion of the mitral valve site and a soft, smooth surface to interact with the native mitral valve. Possible foamed materials include polyethylene terephthalate, polyurethane, and polyurethane- polycarbonate matrices for long-term implantation. Foams can be more advantageous than cloth coverings because foams are generally able to compress to a smaller crimped profile and the amount of swelling in the mitral valve is more effective in reducing the amount of paravalvular leak based on the increased volume of the foam. Additionally, foams can be very compliant and atraumatic to the junction of the mitral valve anatomy. Other advantages of foams include tissue ingrowth and echogenicity. Because foams are generally more porous than other materials, the advantage of tissue ingrowth occurs and the porosity can allow for better or enhanced tissue ingrowth. Improved echogenicity is advantageous because it allows a user such as a physician, cardiologist, surgeon, or other medical professional to view the placement of the prosthetic valve based on the location of the foam expansion.

[0227] As FIG. 5A-FIG. 5F shown, the covering of the prosthetic valve can be further altered to allow for changes in the inflow and outflow portions of the prosthetic valve (e.g., as shown previously, the shape does not have to always be perfectly cylindrical). In these figures, frame 50 has a covering 52 that is machined, heat molded, or otherwise manufactured to allow for a shape of larger outer diameter at inflow portion 54. As FIG. 5A-FIG. 5F shown, various embodiments will have certain shapes. Some embodiments will have a generally conical shape, as FIG. 5A shown, with a larger outer diameter at inflow portion 54 that tapers down to a smaller outer diameter at outflow portion 56. Another group of embodiments will have a curved and tapered covering 52, such as in FIG. 5B , where the covering 52 is wider near inflow portion 54 and has a generally curved tapering toward outflow portion 56.

[0228] Additional embodiments have a generally hourglass shape, such as the shape shown in FIG. 5C to FIG. 5E . As FIG. 5C shown, some embodiments will have a larger outer diameter at inflow portion 54 and outflow portion 56, while having a narrower outer diameter at the middle portion 58 of the prosthetic valve 50. Another shape of covering 52 used in some embodiments is shown in FIG. 5DSome embodiments are shown in FIG. 1, where the covering 52 is slightly retracted from the inflow portion 54 of the prosthetic valve 50 and has a larger outer diameter toward the inflow portion 54; additionally, the covering 52 has a larger outer diameter at the outflow portion 56 and a smaller outer diameter at a location 58 proximate the outflow portion 56. FIG. 5E Embodiments are shown where the covering 52 has a constriction 53 designed to prevent compression of the foam from affecting the volume and / or shape of the first portion 57. Because the constriction 53 is designed to prevent the first portion 57 from being compressed, the constriction 58 can be located anywhere along the body to achieve this goal. For example, the constriction 53 can be proximal to the inflow portion (as shown), or it can be located near the outflow portion 56, or in an intermediate location between the outflow portion 56 and the inflow portion 54. In many of these embodiments, the constriction 53 is a machined slit. In many embodiments with the constriction 53, the overall shape of the covering 52 is cylindrical (e.g., similar to FIG. 4A ), while many embodiments will add contours or other shapes to the covering 52. For example, as shown in FIG. 5E , the first portion 57 has a gradually increasing thickness from the inflow portion 54, while the second portion 59 has a generally curved taper toward the outflow portion 56.

[0229] Turning to FIG. 5F , further embodiments of the prosthetic valve 50 will have a generally mushroom-shaped covering 52, where the covering 52 has a first portion 57 that has a curved increase in thickness from the inflow portion 54 toward the location 58. The covering 52 will also have a second portion 59 that extends from the location 58 toward the outflow portion 56, which has a generally cylindrical shape.

[0230] Note that while some embodiments are shown in FIG. 5A to FIG. 5F with circular sutures, while other embodiments are shown with edge strips and radially horizontal sutures, these illustrations are not meant to limit the type of sutures to any particular embodiment, and many embodiments will have circular sutures or edge strips independent of the shape of the covering 52 on the prosthetic valve 50.

[0231] Turning to FIG. 6AMany embodiments of the covered valve 60 have a cover made of a woven fabric or textile having a plurality of floating yarn segments 61 (e.g., protruding or bulging segments). Details of exemplary covered valves having a plurality of floating yarn segments 61 are further described in U.S. Patent Pre-Publication Nos. US 2019 / 0374337 A1, US 2019 / 0192296 A1, and US 2019 / 0046314 A1, the entire disclosure of which is incorporated herein by reference for all purposes. In some embodiments, the floating segments are separated by one or more horizontal bands 63. In many embodiments, the horizontal bands 63 are constructed via leno weave, which improves the strength of the woven structure. In some embodiments of the woven fabric, the vertical fibers (e.g., extending along the longitudinal axis of the valve 60) comprise yarns or other fibers with a high expansion level, such as textured weft yarns, while the horizontal fibers in the leno weave (e.g., extending circumferentially around the valve 60) comprise low expansion yarns or fibers.

[0232] The floating yarn segment 61 can be heat-set to achieve the desired size and texture, for example, to make it softer and more textured. Texture can be achieved by twisting, heat-setting, and untwisting the constituent fibers of the ply / yarn used in segment 61, thereby allowing the fibers to retain their deformed, twisted shape and producing a fluffy fabric. In some embodiments, the floating yarn segment 61 may be formed from textured PET yarn without any weave structure. In some embodiments, the covering of the covered valve 60 may be heat-shrinkable to achieve stretchability between 80-160%.

[0233] In various embodiments, the woven fabric, when assembled and under tension (e.g., when longitudinally stretched over the compressed valve 60 prior to valve 60 delivery), resembles a greige fabric. As the valve 60 is deployed and expands, the tension on the floating portion 61 is relieved, thereby allowing the floating portion 61 to expand. In many embodiments, the number and size of the floating portions 61 are optimized to provide a degree of expansion to prevent paravalvular leakage across the mitral valve plane (e.g., with a higher level of expansion thickness) and / or a lower curl profile (e.g., for valve delivery), as further described in U.S. Patent Pre-Publication Nos. US 2019 / 0374337 A1, US 2019 / 0192296 A1, and US 2019 / 0046314 A1. Additionally, the band 63 may be optimized to allow attachment of the covering to the valve based on the specific size or location of the strut or other structural elements on the valve.

[0234] In some embodiments, the covered valve 60 (e.g., as...) FIG. 6B (As shown) has a hybrid covering 62, which can include multiple different types of coverings working together. FIG. 6BIn the illustrated example, the first portion 64 of the hybrid covering 62 proximate the inflow portion 66 of the valve 60 includes a foam or other expandable material, while the second portion 68 of the hybrid covering 62 proximate the outflow portion 69 of the valve 60 includes a woven cloth or fabric, which can have one or more expandable portions 61. Further, in FIG. 6B the foam or other expandable material has a larger expanded profile at the inflow portion to increase the ability to form a seal and prevent paravalvular leakage around the mitral plane. This foam cloth hybrid skirt advantageously achieves a low profile when the valve is crimped due to the compressibility of the foam / expandable material and the low profile ability of the woven cloth. The expanded valve expands radially outward at the inflow end to allow for good paravalvular sealing.

[0235] Additionally, FIG. 6B variations on the edge covering 65 are shown. In particular, in many embodiments, the edge covering 65 will have a series of openings 67 FIG. 6C-FIG. 6E ) placed in the edge covering 65. In certain embodiments, the openings are formed via die cutting, laser cutting, stamping, or any other method of forming openings in the material of the edge covering 65. Turning to FIG. 6C and FIG. 6D which show perspective views of the inflow portion 66 FIG. 6C ) and the outflow portion 69 FIG. 6D ) of the valve 60. As can be seen from these figures, the edge covering 65 will have openings 67 on both ends of the prosthetic valve in many embodiments. Further, FIG. 6E a perspective view from the inside of the outflow portion 69 is shown, which shows the edge covering 65 with a series of openings 67. As FIG. 6E shown, the frame 63 of the prosthetic valve of many embodiments has angled struts, which allow for compressibility around a catheter or other delivery device. The openings 67 are cut so that they align between the apexes in the frame 63. By placing the openings between the apexes, the edge covering 65 will not protrude when the prosthetic valve of certain embodiments is crimped around a catheter or other delivery device, thereby minimizing the outer diameter of the crimped valve.

[0236] FIG. 3A-FIG. 6E Various embodiments shown in FIGS. 1-3 are described as foam and / or woven cloth, additional embodiments are constructed from materials that are capable of providing the same effect, including woven PET, knitted PET, woven PET, woven PTFE, knitted PTFE, woven PTFE, ePTFE membrane, electrospun ePTFE, thermoplastic membrane, impregnated thermoplastic, sprayed thermoplastic, foam, and combinations thereof.

[0237] In some embodiments, the prosthetic valve with a covering will utilize a material placed under and / or in conjunction with the covering that can be compressed or manipulated and return to a specific shape once the force is removed. FIG. 7A to FIG. 7B Flange support structure 71 is shown to allow the covering to expand to its full position. Specifically, FIG. 7A to FIG. 7B Flange support structure 71 is shown secured to frame 63 of many embodiments. In many embodiments, flange support structure 71 is secured near inflow portion 72 and at mid position 73 of frame 63. In some embodiments, the securing is done via stitching, welding, or any other suitable method for securing flange support structure 71 to frame 63. In many embodiments, flange support structure 71 has a series of windows 75 that allow flange support structure 71 to protrude radially outward from frame 63 and allow the covering to expand to its full position. FIG. 7C Embodiments of a prosthetic valve are shown with flange support structure 71 crimped onto a delivery device such as a catheter. In FIG. 7C In particular, compressing frame 63 and flange support structure 71 does not drastically increase the outer diameter of crimped frame 63 (double arrow). Flange support structure 71 can be constructed of any suitable material, such as a material that is biocompatible and / or non-traumatic to natural tissue. In certain embodiments, flange support structure 71 is constructed of ePTFE. Additionally, the number of windows 75 placed in flange support structure 71 can be any number that is capable of allowing flange support structure 71 to protrude outward from frame 63. In some embodiments, 8 windows will be cut, but additional embodiments will have 10, 12, 16, 24, or more windows.

[0238] Additional embodiments such as FIG. 8 Additional embodiments are shown with outward struts 77 placed on frame 63 of many embodiments that expand via single filament buckling and / or flexing. In many of these embodiments, outward struts 77 are constructed of a memory material such as Nitinol that can aid in the elastic expansion of the covering, placed under or incorporated into a foam or cloth / fabric covering. Any number of outward struts 77 of many embodiments can be placed at locations that allow the covering to expand. Some embodiments will place outward struts 77 at 3 locations around frame 63, while additional embodiments will place outward struts 77 at 4, 6, or 8 locations around frame 63. In some embodiments, two outward struts 77 are joined to frame 63 at approximately the same location and expand outward in a generally V-shape outward from frame 63, while other embodiments will have a single outward strut 77 at specific locations that expand outward from frame 63. Although outward struts 77 are shown as being placed on frame 63, additional embodiments will have outward struts 77 placed on flange support structure 71. FIG. 8expansion at the atrial or inflow side of frame 63, but similar mechanisms are used to expand the pocket cover in the ventricular or outflow side of frame 63 (e.g., FIG. 4C ) to assist in expansion of the pocket for encapsulation of blood or embolic material.

[0239] It is noted that FIG. 3A to FIG. 8 the embodiments shown are illustrative and are not meant to exclude or limit any other embodiments unless the features shown are not combinable. For example, several embodiments will combine the flange support structures shown such as FIG. 7A to FIG. 7C with the foam cover shown such as FIG. 4A to FIG. 6A any one of FIG. 3A to FIG. 3C and / or the flanges shown in any one of

[0240] Docking device

[0241] Anchor / docking devices (e.g., docking members) according to example embodiments of the present application are shown in FIG. 9A to FIG. 16 and include a coiled shape. Certain docking devices in the atrioventricular position can migrate more distally or more deeply into the ventricular deployment of the docking device than desired. It can be beneficial to avoid excessive “docking member drop-off” to help avoid paravalvular leakage, for example, sealing the docking device and the prosthetic valve seal higher on the native leaflet can help prevent paravalvular leakage that can occur when lower on the chordae. Additionally, a higher placement position (e.g., by avoiding docking member drop-off) can help long-term stability of the valve, as the leaflet is thicker and stronger near the annulus than it is distal to it, thus anchoring at or near the annulus is expected to be stronger and provide long-term stability. Also, a higher placement position of the prosthetic valve can help avoid wear of the valve on the native tissue (e.g., friction on the native leaflet and / or chordae) by making it less likely for the prosthetic valve to rub against the leaflet and / or chordae.

[0242] Paravalvular leakage can be caused by a variety of reasons, including cases where the native valve annulus is too large compared to the prosthetic valve; commissure leaflets are too short and / or damaged; implantation of the docking device does not fully capture the native leaflets; the crossing of the docking device from one side of the valve to the other causes a small gap (e.g., at the commissure); the prosthetic valve is placed off-center, anterior, posterior, and / or medial to the native valve; and / or certain patient anatomical abnormalities (e.g., cleft, disease associated with degenerative mitral regurgitation, etc.). Various embodiments of the present disclosure are designed to compensate for, avoid, reduce, and / or eliminate many of these issues, including by maintaining a dock up on both sides of the native mitral valve (thereby reducing and / or inhibiting docking piece drop-off by keeping the docking piece and prosthetic valve close to the native valve annulus plane), by creating a better seal around the prosthetic valve, by creating a better seal on the native valve annulus, etc. For example, FIG. 9A-FIG. 9C Versions of the docking piece or core of the docking piece are shown that are configured to provide one or more points of contact or areas of contact between the docking piece and the left atrial wall, such as at least three points of contact of the left atrium or full contact on the left atrial wall, while FIG. 10A-FIG. 10C Versions of the docking piece or core of the docking piece are shown that are configured to provide one or more points of contact or areas of contact between the docking piece and the left atrial wall, such as at least three points of contact of the left atrium or full contact on the left atrial wall, while FIG. 11A-FIG. 11C Versions of the docking piece or core of the docking piece are shown that are configured to provide one or more points of contact or areas of contact between the docking piece and the left atrial wall, such as at least three points of contact of the left atrium or full contact on the left atrial wall, while FIG. 9A to FIG. 11C In the example shown in FIG. 1, docking device 70 includes a coiled or wound portion having a plurality of turns extending along a central axis of docking device 70. The coiled or wound portion can be continuous and can extend generally helically in sections of various different sizes and shapes, as described in more detail below. FIG. 9A to FIG. 11C Docking device 70 shown in FIG. 1 can be configured to fit at the mitral valve location, but in other embodiments can be shaped and / or adapted similarly or differently to better accommodate at other native valve locations, such as the tricuspid valve. Advantageously, the geometry of the docking devices of the present disclosure provides engagement with the native anatomy that can provide increased stability and reduce relative motion between the docking device, the prosthetic valve docked therein, and the native anatomy. Reducing this relative motion can prevent material degradation of components of the docking device and / or the prosthetic valve docked therein, and can prevent damage / injury to the native tissue.

[0243] The docking device 70 of many embodiments includes a central region 80 having one coil, coiled portion, or multiple coils (e.g., 2 coils, 3 coils, 4 coils, between 2-5 coils, or more). The coiled portions or coils of the central region 80 can have similar sizes and shapes, or different sizes and / or shapes. In some implementations, the central region 80 includes three or about three full turns of a coil having substantially equal inner diameters. The central region 80 of the docking device 70 serves as a primary landing zone or holding region for holding an expandable prosthetic valve when the docking device 70 and the valve prosthesis are implanted in a patient. In some embodiments, the docking device 70 has a central region 80 with more or less than three turns of a coil depending, for example, on the patient’s anatomy, the desired vertical contact between the docking device 70 and the valve prosthesis (e.g., a transcatheter heart valve or THV), and / or other factors. The coiled portions or one or more coils of the central region 80 can also be referred to as “functional coils” or “functional turns” because the properties of these coils have the greatest impact on the amount of holding force generated between the valve prosthesis, the docking device 70, and the native mitral valve leaflets and / or other anatomical structures.

[0244] Various factors can contribute to the total holding force between the docking device 70 and the prosthetic valve held therein. One primary factor is the number of turns included in the functional coils, while other factors include, for example, the inner diameter of the functional coils, the frictional forces (e.g., between the coils and the prosthetic valve), and the strength of the prosthetic valve and the radial force exerted by the valve on the coils. The docking device can have a variety of numbers of coils and / or turns. The number of functional turns can range from a half turn to 5 turns, or from a full turn to 5 turns, or even more. In one embodiment having three full turns, an additional half turn is included in the ventricular portion of the docking device. In another embodiment, there can be a total of three full turns in the docking device. In one embodiment, there can be a half to three-quarters of a turn or a half to three-quarters of a circle in the atrial portion of the docking device. While ranges of turns are provided, as the number of turns in the docking device is reduced, the size and / or material of the wire from which the coils are made can also be changed to maintain an appropriate holding force. For example, in a docking device having fewer coils, the diameter of the wire can be larger and / or the diameter of the functional coil(s) turn(s) can be larger. There can be multiple coils in the atrium and ventricle.

[0245] The size of the one or more functional coils or coils of the central region 80 is typically selected based on the size of the desired THV to be implanted in a patient. Generally, the inner diameter 90 of the functional coil(s) (e.g., the inner diameter of the coils of the central region 80 of the docking device 70) will be less than the outer diameter of the expandable heart valve so that when the prosthetic valve is expanded in the docking device, additional radial tension or retention force will act between the docking device and the prosthetic valve to hold the prosthetic valve in place. The retention force required for proper implantation of the prosthetic valve varies based on the size of the prosthetic valve and the ability of the assembly to handle mitral pressures of about 180 mm Hg. For example, based on hemodynamic data using a prosthetic valve with an expanded outer diameter of 29 mm, at least 15.8 N of retention force can be required between the docking device and the prosthetic valve in order to securely hold the prosthetic valve in the docking device and resist or prevent valve regurgitation or leakage. However, under this example, to meet this 15.8 N retention force requirement on a statistical reliability basis, the target average retention force should be substantially higher, such as about 30 N.

[0246] In many embodiments, when the difference between the outer diameter of the prosthetic valve in its expanded state and the inner diameter of the functional coils is less than about 5 mm, the retention force between the docking device and the valve prosthesis decreases dramatically because the reduced size difference can be too small to generate sufficient retention force between the components. For example, in one embodiment, when a prosthetic valve with an expanded outer diameter of 29 mm is expanded in a set of coils with an inner diameter of 24 mm, the observed retention force is about 30 N, but when the same prosthetic valve is expanded in a set of coils with an inner diameter of 25 mm (e.g., only 1 mm larger), the observed retention force drops significantly to only 20 N. Thus, in certain embodiments, in order to generate sufficient retention force between the docking device and a 29 mm prosthetic valve, the inner diameter of the functional coils (e.g., the coils of the central region 10 of the docking device 1) should be 24 mm or less. Generally, the inner diameter of the functional coils (e.g., the central region 80 of the docking device 70) should be selected to be at least about 5 mm less than the prosthetic valve selected for implantation, although other features and / or characteristics (e.g., friction enhancing features, material characteristics, etc.) can be used to provide better retention force using other size ranges, as various factors can affect the retention force.

[0247] However, the diameter of the functional coil should be selected based on a consideration and balancing of multiple factors to achieve optimal results. For example, the native anatomy between the mitral annulus at the mitral plane and the papillary muscle heads forms a generally trapezoidal shape, and the tissue of the mitral leaflets is thicker near the mitral plane and thinner below the mitral plane. A smaller diameter of the central region 80 can encourage the docking device 70 to be installed lower than desired below the mitral plane (a similar effect can also be observed at the tricuspid valve). This can result in a suboptimal anchoring position of the prosthetic valve when docking occurs at a location where the mitral leaflets are thinner. Thus, a size, diameter, and other features that help hold the prosthetic valve higher on the leaflets can be beneficial. Additionally, the size of the inner diameter of the functional coil or central region 80 can also be selected to pull the native anatomy closer together in order to at least partially compensate for or counteract the valve regurgitation that results from the native valve annulus stretching out due to, for example, left ventricular enlargement.

[0248] It is noted that the desired holding force discussed above applies to embodiments of mitral valve replacement. Thus, other embodiments of docking devices for replacement of other valves can have different size relationships based on the holding force needed to replace the valve at those respective locations. Additionally, the size differences can also vary, for example, based on the materials used for the valve and / or docking device, whether there are any other features that prevent the functional coil from expanding or enhance friction / locking, and / or based on other various other factors.

[0249] In embodiments where the docking device 70 is used at the mitral valve location, the docking device can first be advanced and delivered to the native mitral annulus and then set at the desired location before implanting the prosthetic heart valve. In some embodiments, the docking device 70 is flexible and / or made of a shape memory material so that the coils of the docking device 70 can also be straightened for delivery via a transcatheter method. In some embodiments, the coils are made of another biocompatible material, such as stainless steel. Certain same catheters and other delivery tools can be used for the delivery of the docking device 70 and the prosthetic valve without having to perform separate preparation steps, thereby simplifying the implantation procedure for the end user.

[0250] Because the functional coils / turns or coil / turns of the central region 80 of the docking device 70 are relatively small in diameter (e.g., in one embodiment, the inner diameter of the central region 80 can be between about 21-24 mm (e.g., ± 2 mm) or another diameter that is less than the prosthetic valve and / or native valve annulus) in order to increase retention with the prosthetic valve, it can be difficult to advance the docking device 70 around the existing leaflets and / or chordae tendinae to the desired position relative to the native mitral annulus. This is especially true if the entire docking device 70 has the same small diameter as the central region 80. Thus, the docking device 70 can have a distal region or lower region 82 that includes and / or consists of a leading coil / turn (sometimes referred to as a wrap-around turn or a leading ventricular coil / turn) of the docking device 70 that has a lower diameter that is greater than the diameter of the functional coils / turns or coils / turns of the central region 80.

[0251] The features of the native anatomy (especially in the left and right ventricles) have variable sizes. For example, the native mitral valve anatomy can have a maximum width in the long axis of about 35 mm to 45 mm. The diameter or width of the wrap-around turn or leading coil / turn (e.g., ventricular coil / turn) of the lower region 82 can be selected to be larger to more easily navigate the distal or leading end 84 of the docking device 70 around and around the features of the native anatomy (e.g., leaflets and / or chordae tendinae).

[0252] Various sizes and shapes are possible, e.g., in one embodiment, the diameter can be any size from 25 mm to 75 mm. The term “diameter” as used in this disclosure does not require that the coil / turn be a complete or perfectly shaped circle, but is generally used to refer to the maximum width across opposite points of the coil / turn. For example, with respect to the leading coil / turn, the diameter can be measured from the distal end 84 to the opposite side as if the lower region or leading coil / turn 82 formed a complete one turn, as shown by the diameter 91 in FIG. 9A Alternatively, this diameter can be considered to be twice the radius of curvature of the leading coil / turn. In various embodiments, the diameter 91 of the lower region 82 is sufficient to wrap around the anatomical features within the ventricle, including the mitral valve leaflets and chordae tendinae, such that the inner diameter of the lower region 82 is equal to or greater than the inner diameter of the central region 80 (e.g., FIG. 10AThe illustrated diameter 90). Other embodiments are designed to be atraumatic to other ventricular anatomies, including walls or septums within the ventricle. As such, the diameter 91 of the lower region 82 is small enough to not contact the walls or septums. In certain embodiments, the diameter 91 of the lower region 82 is in the range of about 33-37 mm (e.g., ± 2 mm). In one embodiment, the lower region 82 of the docking device 70 (e.g., the lead coil / turn) has a diameter 91 of 43 mm or about 43 mm (e.g., ± 2 mm), in other words, the radius of curvature at the lead coil / turn can be 21.5 mm or about 21.5 mm (e.g., ± 2 mm). In other embodiments, the diameter 91 of the lower region 82 of the docking device 70 is in the range of 28-38 mm, 30-36 mm, 31-35 mm, 32-34 mm, or 32.5-33.5 mm (e.g., a radius of curvature in the range of 16.25-16.75 mm).

[0253] The lead coil / turn having a larger size than the functional coils can help more easily guide the coils around the geometry of the chordae tendinae and / or guide the coils through the geometry of the chordae tendinae, and most importantly, properly around both native leaflets of a native valve (e.g., a native mitral valve, tricuspid valve, etc.). Once the distal tip 84 navigates around the desired native anatomy, the remaining coils of the docking device 70 can also be guided around the same feature. In some embodiments, the size of the other coils can be sufficiently reduced such that the corralled anatomical feature is pulled radially inward or slightly radially inward. At the same time, the length of the enlarged lower region 82 or lead coil / turn can remain relatively short to prevent or avoid obstruction or interference with blood flow along the ventricular outflow tract by the lower region 82 or lead coil / turn. For example, in one embodiment, the enlarged lower region 82 or lead coil / turn extends for only about half a coil or turn. With the lower region 82 or lead coil / turn having a relatively short length, when the prosthetic valve is expanded into the docking device 70 and the coils of the docking device 70 begin to slightly loosen due to the size difference between the docking device and the prosthetic valve, the lower region 82 or lead coil / turn can also be pulled in and slightly displaced. Under this example, after the prosthetic valve is expanded, the lower region 82 or lead coil / turn can be similar in size and substantially aligned with the functional coils of the docking device 70, rather than continuing to protrude from the functional coils, thereby reducing any potential flow interference. Other docking device embodiments can have a longer or shorter lower region depending on the particular application.

[0254] In various embodiments, FIG. 9A to FIG. 1The docking device 70 shown in FIG. 1 also includes an enlarged proximal or upper region 86 that includes and / or consists of stabilizing coils / turns of the docking device 70 (e.g., which can be atrial coils / turns). During transitional or intermediate stages of the implantation procedure, i.e., during the time between deployment and release of the docking device 70 and final delivery of the prosthetic valve, the coils can shift and / or move from their desired position or orientation, e.g., due to regular heart function. Shifting of the docking device 70 can potentially result in less safe implantation, misalignment, and / or other positioning issues of the prosthetic valve. A stabilizing feature or coil can be used to help stabilize the docking device in the desired position. For example, the docking device 70 can include an upper region 86 having enlarged stabilizing coils / turns (e.g., enlarged atrial coils / turns having a larger diameter 92 and / or 94 than the functional coils) that are intended to be positioned in the circulatory system (e.g., in the left atrium) such that they can stabilize the docking device. For example, the upper region 86 or stabilizing coils / turns can be configured to abut or push against the wall of the circulatory system (e.g., against the wall of the left atrium) in order to improve the ability of the docking device 70 to stay in its desired position prior to implantation of the prosthetic valve.

[0255] The stabilizing coils / turns (e.g., atrial coils / turns) at the upper region 86 of the docking device 70 in the illustrated embodiment can extend for about one full turn or revolution and terminate at a proximal end 88. In other embodiments, the stabilizing coils / turns (e.g., atrial coils) can extend for more or less than one turn or revolution, depending on, for example, the desired amount of contact between the docking device and the circulatory system (e.g., between the docking device and the wall of the left atrium) in each particular application. The radial size of the stabilizing coils / turns (e.g., atrial coils) at the upper region 86 can also be significantly larger than the size of the functional coils in the central region 80, such that the stabilizing coils / turns (e.g., atrial coils or atrial turns) flare out or extend sufficiently outward to contact the wall of the circulatory system (e.g., the wall of the left atrium). Additionally, the stabilizing coils / turns of various embodiments will be configured to be less abrasive to the native tissue and / or anatomy. For example, the surface texture can be made smoother and / or softer, such that movement of the docking device against the native anatomy will not damage the native tissue.

[0256] The proximal tip 88 shown in these figures also includes an eyelet or hole. The eyelet at the proximal tip will be used to secure the docking device 70 to the delivery system (as described below) through various means including sutures. As such, various embodiments that include an eyelet at the proximal tip 88 will utilize different shapes and sizes of the eyelet. As such, some embodiments will use a larger eyelet while other embodiments will use a smaller eyelet. Additionally, in certain embodiments, the shape will vary such that some embodiments will have a circular eyelet while other embodiments will use a D-shaped eyelet. Furthermore, various embodiments will not have an eyelet as shown, but will have a hole drilled in the docking device itself, such as a laser-drilled hole.

[0257] Turning to FIG. 9A to FIG. 9C , these figures represent the docking device, but also represent the core that can be covered and / or added to form the docking device. The stabilizing coil 86 is designed to create a plane formed by at least three points of contact in the atrium. The three anchor points or points of contact are the posterior frame of the native valve (e.g., mitral valve, etc.), the anterior wall of the atrium, and the atrial appendage of the atrium or lateral frame of the native valve. This plane formed by the three points of contact will be parallel to the plane of the native valve, which will maintain the docking device in parallel to the native valve plane. In some embodiments, the diameter of the stabilizing coil is desirably larger than the annulus, the native valve plane, and the atrium to better stabilize, but the stabilizing coil is flexible and has a thin cross-section to prevent damage to the patient’s atrium from long-term placement of the docking device 70.

[0258] Suitable materials for the docking device include nitinol cores with core sizes ranging from about 0.3 mm to about 1 mm. The flexible core will allow the stabilizing coil to adapt to various atrial shapes and sizes. Additionally, in some embodiments with a three-point contact design as shown in FIG. 9B and FIG. 9C , the stabilizing coil is designed to cross the functional coil lower or down when unconstrained (e.g., when not installed into a patient’s native valve). This can advantageously lift the functional coil (central region 80) relative to the native anatomy, the plane of the native valve, and the leaflets when implanted. For example, when deployed in the atrium, the stabilizing coil crossing proximally from the central region or functional coil to distally of the central region / functional coil or toward distally of the central region / functional coil pushes down on the atrium and / or native valve plane to move or bias the central region / functional coil higher up on the ventricular side of the valve and higher up under the leaflets.

[0259] With regard to FIG. 10A to FIG. 10D , these figures represent the docking device, but also represent the core that can be covered and / or added to form the docking device. In FIG. 10A-FIG. 10DIn some embodiments, the docking device 70 is designed with a flat stabilizing coil 86 that seats on the plane of the native valve (e.g., on the native mitral valve plane or the native tricuspid valve plane). In these embodiments, the stabilizing coil 86 is designed to be larger than the opening of the native valve (e.g., mitral or tricuspid valve), but not so large that the stabilizing coil 86 does not seat on the plane of the native valve. The stabilizing coil 86 can form a continuous curve as shown, or can flare outward or bias toward the atrial wall as shown, thereby utilizing the posterior shelf to prevent the docking device 70 from falling into the ventricle prior to deployment of the prosthetic or artificial valve therein. Additionally, in certain flat embodiments, the stabilizing coil will have a smooth covering to prevent trauma to the native anatomy in areas that exhibit relative motion (e.g., the area where the docking device 70 traverses from the atrium to the ventricle through the mitral valve). FIG. 10A FIG. 10B

[0260] Turning to FIG. 11A to FIG. 11C , these figures represent docking devices, but also represent the core that can be covered and / or added to form a docking device. In FIG. 11A to FIG. 11C , a hybrid docking design is shown that is configured to improve the prevention and / or inhibition of paravalvular leakage. In this hybrid docking device 70 embodiment, the stabilizing coil 86 is designed to form a tighter ring around the deployed prosthetic valve, thereby helping to seal the valve and prevent paravalvular leakage. In some embodiments, this sealing effect is maximized by having the docking device core radially offset outward from the maximum valve outer diameter (OD) plus half the radius of the docking device cross-section. In some embodiments, the stabilizing coil 86 allows for a maximum outer diameter (e.g., optimal contact with the atrium) to also help with docking device drop-off prior to prosthetic valve deployment. Additionally, in some embodiments, the docking device is configured such that after prosthetic valve deployment, the stabilizing coil will be flush with the outer diameter of the implanted and expanded prosthetic valve. This hybrid design can be manufactured to rely on different prosthetic valve outer diameters to prevent paravalvular leakage tightly around the prosthetic valve. For example, the docking device can be designed to accommodate valves with an outer diameter of about 30 mm or about 34 mm, or any diameter in between. Additionally, the docking device 70 can be sized to handle prosthetic valves with outer diameters ranging from about 20 mm to about 50 mm.

[0261] ​​In some embodiments, the various docking devices herein are configured to have a small enough cross-section during delivery to fit within a catheter / sleeve / sheath of a delivery device (discussed in more detail below), but to expand after deployment to maximize OD and form an improved seal around the prosthetic valve after implantation. Additionally, some embodiments include and / or utilize materials configured to optimize tissue ingrowth (e.g., having pores and / or other openings sized to provide more available surface area to help facilitate such ingrowth). In some embodiments, the pores and / or openings are about 30-1000 pm in size, which can facilitate optimal tissue ingrowth. Tissue ingrowth can improve the seal and better integrate with native valve anatomy to stabilize the docking device and prosthetic valve and prevent wear and / or damage over time. In certain embodiments, the docking device can include a material having openings (e.g., pores) sized in the range of about 400-800 pm, 500-750 pm, 500-660 pm, 600-650 pm, or 625-650 pm.

[0262] The various docking devices herein can also incorporate additional modifications to the central region 80 (e.g., functional coils) and / or stabilizing coils (e.g., elements 86) in FIG. 9A to FIG. 11C to improve the functionality of the docking device. Examples of some such additional modifications are shown in FIG. 9A to FIG. 11C . FIG. 12A to FIG. 16

[0263] FIG. 12A to FIG. 12G Examples of possible coverings 100 are shown that can be placed over the docking device (e.g., the docking device 10 in FIG. 9A to FIG. 11C ​All or only a portion of the docking device 70 shown or shown elsewhere herein can be covered by the covering 100 to form a seal against the prosthetic valve and reduce paravalvular leakage. In many embodiments, the covering 100 covers primarily or only the stabilizing turns / coils (e.g., atrial turns / coils) or a portion thereof. In some embodiments, the covering 100 is attached on the atrial turns and extends in the central region toward the functional turns and / or over a portion of the functional turns. In some embodiments, the covering 100 is attached on the functional turns and extends toward the atrial turns. Certain embodiments have the covering 100 only over the functional turns. In some embodiments, the covering 100 extends over the entirety of the docking device 70. When over the stabilizing coils / turns or atrial coils / turns, the covering 100 can help cover the atrial side of the atrioventricular valve to prevent and / or inhibit blood from leaking through the native leaflets, commissures, and / or the exterior periphery of the prosthetic valve by stopping blood in the atrium from flowing in the atrium-to-ventricle direction without flowing through the prosthetic valve. In some embodiments, the covering 100 is configured to have a compressed configuration for delivery to the heart valve through the vasculature with a narrow profile and an expanded configuration in which the covering 100 is expanded to a larger outer diameter (which can advantageously help prevent and / or or inhibit paravalvular leakage).

[0264] In some embodiments, the covering 100 can expand to a diameter of about 5 mm (e.g., ±4 mm) to prevent and / or inhibit paravalvular leakage. In some embodiments, the covering 100 is configured to expand such that an improved seal is formed closer to and / or against the prosthetic valve in which it is deployed (such as described above with respect to FIG. 11A to FIG. 11C In some embodiments, the covering 100 is configured to prevent and / or inhibit leakage of the docking device 70 at locations where the docking device 70 crosses between the leaflets of the native valve (e.g., without the covering 100, the docking device can push the leaflets apart at the leaflet crossing points and allow leakage at that point (e.g., along the docking device or its sides), but the covering 100 can be configured to expand to cover and / or fill in any openings at that point and inhibit leakage along the docking device.

[0265] In some embodiments, for example, as FIG. 12AAs shown, the cover 100 may include and / or be composed of expandable foam. In some embodiments, the cover includes and / or is composed of expandable foam as a memory foam, such that when the curling pressure is removed before delivery of the docking device 70, the foam will expand into a specific shape or a specific preset shape. Examples of such foams are polyethylene terephthalate (PET), polyurethane, and polyurethane-polycarbonate matrices. In some embodiments, the foam is configured to expand the cross-sectional diameter of the docking device 70 such that the cross-sectional diameter in the region of the cover is 2 mm to 7 mm. Additionally, in some embodiments utilizing foam, the foam includes sufficiently large pores to be non-invasive to natural anatomical structures and allow tissue to grow inward.

[0266] In some embodiments, the cover 100 includes an expandable, non-foam structure on the docking device 70. For example, such as FIG. 12B As shown, the cover 100 may include a woven structure on the docking device 70. Prior to deployment of the docking device 70, the woven structure may be stretched within the sleeve or cover, but after deployment, the woven structure may be allowed to expand to its maximum possible diameter to form a seal. In some embodiments, the woven structure is a woven shape memory material (e.g., shape memory alloy, shape memory metal, nitinol, etc.) that is shape-set and / or pre-configured to expand into a specific shape and / or size when unconstrained and deployed at the natural valve.

[0267] exist FIG. 12C In some embodiments, the covering 100 comprises multiple layers of the same and / or different materials. In these embodiments, the covering (such as a woven structure, foam, or expandable non-foam structure) may be covered by a second covering 102. In these embodiments, the second covering 102 is designed to be non-invasive to natural tissue and / or promote tissue ingrowth into the second covering 102 and possibly the first covering 100. The second covering may be made of any suitable material, including foam, fabric, textile, and / or polymer, which is flexible to allow the first covering 100 and the second covering 102 to compress and expand.

[0268] Movement between the docking device 70 and the covering 100 can cause trauma to natural tissue; therefore, several embodiments of the docking device 70 incorporate means to restrict movement, thereby reducing the risk of trauma to natural tissue. [Go to...] FIG. 12D An embodiment of a covered docking device with woven stabilizing coils 86 is shown. In, for example... FIG. 12DIn the illustrated embodiment, the woven texture on the stabilizing coil 86 of the docking member can interact with the covering 100 that surrounds the stabilizing coil 86. By creating an interaction between the stabilizing coil 86 and the covering 100, movement of the docking device 70 can be reduced, thereby limiting trauma to the native tissue.

[0269] In FIG. 12E , an embodiment of a docking device 70 is shown with a covering 100 over the functional coil in the central region of the docking device. Similar to the example shown in FIG. 12B , the covering 100 can include a woven structure on the docking device 70. The woven structure can be stretched inside a sleeve or covering prior to deployment of the docking device 70, but can be allowed to expand to its maximum possible diameter to form a seal after deployment. In some embodiments, the woven structure is a woven shape memory material (e.g., shape memory alloy, shape memory metal, nitinol, etc.) that is shape set and / or pre-configured to expand into a particular shape and / or size when unconstrained and when deployed at a native valve. As FIG. 12E shown, the docking device 70 can have an extension 140 that is generally located between a central region 142 having functional turns and an upper region 144 having atrial turns. As described elsewhere herein, the docking device 70 can have a lower region 146 having surrounding turns with a larger diameter relative to the functional turns in the central region 142. In FIG. 12E , the extension 140 is made up of or includes a vertical portion of the coil that extends substantially parallel to the central axis of the docking device 70. In some embodiments, the extension 140 can be angled relative to the central axis of the docking device 70, but will generally serve as a vertical or axial spacer that spaces adjacent connecting portions of the docking device 70 in a vertical or axial direction, thus creating a vertical or axial gap between the coil portions on either side of the extension 140 (e.g., a gap can be created between the upper or atrial side and the lower or ventricular side of the docking device 70). In certain embodiments, the extension 140 is intended to be positioned at or near the anterolateral commissure AC when the docking device 70 is implanted, with the covering 100 spanning the mitral annulus plane and positioned such that a portion of the covering 100 is positioned in the posteromedial commissure PC. Additional details of an exemplary shape of the docking device 70 with an extension 140 can be seen in U.S. Pre-Grant Patent Publication No. US 2018 / 0055628 Al, which is incorporated herein in its entirety for all purposes.

[0270] Turning to FIG. 12E, showing an embodiment of the docking device 70 in which the cover 100 extends over the top functional turn of the central region. In such embodiments, the cover 100 can help cover the ventricular side of the atrioventricular valve to prevent and / or inhibit blood leakage through the native leaflets, commissures, and / or the outer periphery of the prosthetic valve by impeding blood flow in the atrium in the atrium-to-ventricle direction without flowing through the artificial valve. Similar to the example shown in FIG. 12B , the cover 100 can include a woven structure on the docking device 70. The woven structure can be stretched inside a sleeve or cover prior to deployment of the docking device 70, but can be allowed to expand to its maximum possible diameter to form a seal after deployment. In some embodiments, the woven structure is a woven shape memory material (e.g., shape memory alloy, shape memory metal, Nitinol, etc.) that is shape set and / or pre-configured to expand into a particular shape and / or size when unconstrained and deployed at the native valve. In some embodiments, the cover 100 is attached on the atrial turn and extends in the central region toward the functional turn and / or over a portion of the functional turn. In some embodiments, the cover 100 is attached on the functional turn and extends toward the atrial turn. In further embodiments, the cover 100 can be attached to the docking device core at both ends of the cover 100 and have a free-floating portion between them. Additionally, the cover 100 can include and / or consist of an expandable foam. In some embodiments, the cover includes and / or consists of an expandable foam that is a memory foam such that upon removal of the crimping pressure prior to delivery of the docking device 70, the foam will expand into a particular shape or a particular pre-set shape, similar to the example in FIG. 12A .

[0271] FIG. 12F and FIG. 12G shows different arrangements of various components that can be integrated on or around the stabilizing coil 86 of many embodiments. In particular, FIG. 12F shows a cross-section of the stabilizing coil 86 as well as the cover 100 and the second cover 102. As shown, with the expansion of the cover 100 and the second cover 102, a cavity 104 is formed between the stabilizing coil 86 and the covers 100, 102. Also shown is the construction of the atrial turn including a core 106, which can be, for example, a NiTi core, or a core made of or including one or more of a variety of other biocompatible materials. FIG. 12F Also shown is a tubular layer 108 that provides a padding-type layer for cushioning the atrial turn from native tissue. In certain embodiments, the tubular layer 108 is composed of ePTFE. FIG. 12FA woven layer 110 is further shown placed on the tubular layer 108. As described above, the woven layer 110 is designed to interact with the covering 100 to limit motion and / or limit trauma to the native tissue. It is noted that, FIG. 12F Various options can be utilized in the construction of the docking device of various embodiments, and the particular arrangement is illustrative of only some embodiments. As such, many embodiments will not have all of the components shown in the construction of the docking device. FIG. 12F

[0272] In some embodiments, FIG. 12F The cross-sections shown in the loops can be achieved in FIG. 12B-FIG. 12D In addition, in some embodiments, the stabilizing loop 86 can have two portions, a first portion having a cross-section as shown in FIG. 12F and an adjacent second portion having a cross-section as shown in FIG. 12G In addition to not including the woven layer 110, the cross-section shown in FIG. 12G may be the same as the cross-section shown in FIG. 12F In some embodiments, as shown in FIG. 12E The area of the covering 100 can be divided into two portions (as shown by the dashed lines), including a first portion extending in the direction of arrow 12F and a second portion extending in the opposite direction as shown by arrow 12G. The first portion can have a cross-section as shown in FIG. 12F and the second portion can have a cross-section as shown in FIG. 12G In certain embodiments, the total cross-sectional diameter of the first portion having a cross-section as shown in FIG. 12F may be smaller than the total cross-sectional diameter of the second portion having a cross-section as shown in FIG. 12G One potential advantage of these embodiments is a reduced likelihood of LVOT (left ventricular outflow tract) obstruction due to the reduced cross-sectional diameter of the portion of the covering 100, 102 that occurs in the left ventricle below the anterior leaflet.

[0273] FIG. 12H A circumferential span 130 around the mitral annulus is shown, which generally illustrates an exemplary extent of the covering 100 that can be included in certain embodiments of the docking device 70. FIG. 12H A plan view of the mitral valve, with the posterior portion down and the anterior portion up. In a healthy heart, the annulus of the mitral valve MV creates a shape and tension of the anatomy such that the posterior leaflet PL and the anterior leaflet AL join in the orifice of flow, creating a tight junction under peak systolic pressure or cardiac contraction pressure, as shown in FIG. 12H ​As shown. The mitral valve MV annulus has a posterior aspect attached to the posterior leaflet (PL) and an anterior aspect attached to the anterior leaflet (AL). The places where the leaflets meet on opposite medial and lateral sides of the annulus are called lobular commissures: the anterolateral commissure (AC) and the posteromedial commissure (PC). The posterior leaflet, starting from the anterior commissure, extends counterclockwise to the posterior commissure, dividing into three scallops or cusps, sometimes designated P1, P2, and P3. The posterior scallops P1, P2, and P3 define specific arcs around the posterior periphery of the annulus, which can vary depending on a variety of factors, including actual measurements of the posterior lobular scallops of the mitral valve and surgeon's preference. However, typically, the principal axis 122 of the mitral valve annulus intersects with both the first posterior scallop P1 and the third posterior scallop P3 approximately at the commissures AC and PC, while the minor axis 124 intersects with the intermediate posterior scallop P2 and roughly bisects it. FIG. 12H As shown, the anterior leaflet also has scallops or regions labeled A1, A2, and A3. The anterior leaflet AL of the mitral valve is attached to the fibrous portion FA of the mitral annulus, which occupies approximately one-third of the total periphery of the mitral annulus. The muscular portion of the mitral annulus constitutes the remainder of the mitral annulus, to which the posterior leaflet PL is attached. The anterior fibrous annulus FA (with its two ends called fibrous triangles T) forms part of the central fibrous body of the heart. The anterior commissure AC and posterior commissure PC are located just posterior to each fibrous triangle. The fibrous mitral annulus FA is closely abutted or adjacent to the aorta AV (particularly the left coronary sinus LCS and non-coronary sinus NCS). The central fibrous body is highly resistant to elongation; therefore, most of the dilation of the mitral annulus occurs in the posterior two-thirds of the annulus, or around the muscular mitral annulus. With or without the additional covering 102, the covering 100 can be provided on the docking device 70 at implantation at the desired length, which has a circumferential span 130. In some embodiments, the covering 100 may extend from a first radial angular position 134 in the left ventricle through the PC and into the left atrium, and extend to a second radial angular position 136 in the left atrium. FIG. 12H In the diagram, the first angular position 134 is shown as a point between PC and AC, but in other embodiments, the circumferential span 130 may further extend around the annulus toward or across AC, or may extend around the annulus at a smaller radial angle, such as... FIG. 12H An example angular position 138 is shown in the figure.

[0274] In various embodiments, the first radial angular position can be at one of various positions relative to the anatomy of the mitral annulus upon implantation. In some embodiments, the first radial angular position 134 can be at a radial angular position corresponding to a point in Al, a point in A2, or a point in A3. In certain embodiments, the first radial angular position 134 is below the A2 region of the AL upon implantation, which can provide the advantage of reducing the risk of LVOT obstruction. In some embodiments, the first angular position 134 is selected to avoid overlap with the adjacent aortic valve structures of the left coronary sinus LCS and the non-coronary sinus NCS. In other embodiments, the first radial angular position 134 can be at a point representing a percentage of the circumferential distance from the PC to the AC (in the counterclockwise direction shown in FIG. 12H about 10%, about 20%, about 30%, about 40%, about 50% (about midway through A2, about the point of intersection with the short axis 124), about 60%, about 70%, about 80%, about 90%, or about 100% (at about the AC).

[0275] In various embodiments, the second radial angular position 136 can be at one of various positions relative to the anatomy of the mitral annulus upon implantation. In some embodiments, the second radial angular position 136 can be at the radial angular position 132 at or near the AC. In other embodiments, the second radial angular position 136 can be at a point in PI, a point in P2, or a point in P3. In yet other embodiments, the second radial angular position 136 can be at a point representing a percentage of the circumferential distance from the PC to the AC (in the clockwise direction shown in FIG. 12H about 10%, about 20%, about 30%, about 40%, about 50% (about midway through P2, about the point of intersection with the short axis 124), about 60%, about 70%, about 80%, about 90%, or about 100% (at about the AC). In further embodiments, the covering 100 can extend all the way to the radial angular position 132 of the AC and up onto the portion of the extension 140 of the docking device 70 that extends into the left atrium.

[0276] In certain embodiments, the first radial angular position 134 and the second radial angular position 136 can be selected such that the covering 100 forms a complete circumferential span around the MV. In some embodiments, both radial angular positions 134, 136 can be at or near the AC. In certain embodiments, the first radial position 134 can be selected such that, as shown in FIG. 12H the covering 100 extends counterclockwise in the left ventricle beyond the second radial angular position 136 such that the covering 100 is implanted with a total radial angular length that exceeds one complete circumference of the MV.

[0277] In some embodiments, a sleeve or sheath is provided to prevent the cover 100 from expanding prior to the deployment of the docking device 70. This additional sleeve or sheath may be integrated into the delivery system and / or delivery device (e.g., as will be referred to below). FIGS. 17A-20D , FIGS. 22A-22C , FIGS. 24A-24B and FIGS. 33-34 (As described). In some embodiments, the sleeve or sheath may be a biodegradable or bioabsorbable material, such that the sleeve or sheath will degrade over a period of time after deployment without requiring additional manufacturing of the delivery device or user withdrawal of the sleeve or sheath. In these cases, the sleeve or sheath may be more like a coating on a cover. In embodiments using a bioabsorbable sleeve, the material may be designed to biodegrade over a period of time sufficient to allow for the deployment and / or redeployment of the docking device 70 and / or the artificial valve without hindering the work of physicians, surgeons, or other medical professionals in deploying the docking device 70 or the artificial valve.

[0278] In such FIGS. 12A-12G In some embodiments of the docking device with cover 100 shown, the cover is made of the following materials: woven NiTi, woven NiTi covered with woven PET, woven NiTi covered with woven PET, woven NiTi covered with knitted PET, woven NiTi covered with an ePTFE film, woven NiTi covered with electrospun ePTFE, woven NiTi immersed in an elastomer, woven NiTi sprayed with an elastomer, and woven NiTi between thermocompressed layers of a thermoplastic film. The composite woven material comprises one or more of the following: foam, PET fabric, PET woven cloth, PET knitted cloth, composite woven material having NiTi and PET yarns, woven PET covered with woven PET, braided PET, knitted PET, ePTFE film, electrospun ePTFE, composite woven material having NiTi and PET yarns impregnated in or sprayed with an elastomer, composite woven material having NiTi and PET yarns between thermoplastic film heat-compressed layers, or combinations thereof. In some embodiments, the composite woven material may include a woven composite material having 48 yarn ends, wherein 30 yarn ends comprise PET and 18 yarn ends comprise NiTi. In further embodiments, the cover 100 may be impregnated with growth factors to stimulate or promote inward tissue growth, such as transforming growth factor α (TGF-α), transforming growth factor β (TGF-β), basic fibroblast growth factor (bFGF), vascular endothelial growth factor (VEGF), and combinations thereof.

[0279] Various docking devices herein can include a braided or woven texture or covering on various surfaces of the docking device. For example, a docking device having a braided or woven texture or covering on the central region or functional coil can beneficially help increase the amount of friction between the docking device, native anatomy, and / or prosthetic heart valve when the prosthetic heart valve is deployed in the docking device, which can help improve retention. This can also provide a greater surface area for tissue ingrowth. While these textures provide benefits such as better prosthetic valve retention, the texture can also cause unnecessary friction on the native anatomy when the docking device is in place at the native valve, which can slow deployment of the docking device and / or can cause damage to the native anatomy. In some embodiments, the braided or woven texture or covering is part of and / or tightly against an outer wall of the docking device to maintain a low profile and safe position. In some embodiments, the braided or woven texture or covering includes an ePTFE covering and / or a PET covering.

[0280] FIGS. 13A-13C A schematic and cross-sectional view showing a portion of an example docking device configured to improve retention between the docking device and a replacement valve is shown. FIG. 13A A portion of three turns of the docking device 70, such as the central region 80, is shown, while FIG. 13B A cross-sectional view of the docking device 70 is shown. The docking device 70 includes a main coil or core 1102, which can be, for example, a NiTi coil / core, or a coil / core made of or including one or more of various other biocompatible materials. The docking device 70 further includes a covering 1104 covering the coil / core 1102. The covering 1104 can be made of or include a high-friction material, such that when the expandable valve is expanded in the docking device 70, an increased amount of friction is created between the valve and the covering 1104 to retain the shape of the docking device and prevent or inhibit the docking device 70 from loosening. In some embodiments, the covering also or alternatively increases the amount of friction between the docking device and the native leaflets and / or prosthetic valve to help retain the relative positions of the docking device, leaflets, and / or prosthetic valve. In some embodiments, the covering 1104 is made of one or more high-friction materials placed over the coil / core 1102. In some embodiments, the covering 1104 is made of or includes a PET weave.

[0281] In additional embodiments, the covering 1104 is made of an ePTFE tube (e.g., FIG. 13CThe ePTFE tube is porous, providing a cushioned, packed layer for the struts or other portions of the frame of the expandable valve to dig into, improving the engagement between the valve and the docking device 70. At the same time, the PET layer provides additional friction to the native valve leaflets as the prosthetic valve expands, and the struts or other portions of the valve frame exert outward pressure on the docking device 70. These features can work together to increase the radial force between the docking device 70 and the native leaflets and / or the prosthetic valve, thereby also increasing the retention force and preventing the docking device 70 from coming loose.

[0282] In other embodiments, the covering 1104 can be made of one or more other high-friction materials that cover the coil 1102 in a similar manner. The choice of material or materials used to make the covering 1104 can also facilitate rapid tissue ingrowth. Additionally, in some embodiments, the outer surface of the frame of the replacement valve can also be covered with a cloth material or other high-friction material to further increase the frictional force between the docking device and the valve, further reducing or preventing the docking device from coming loose. The friction provided by the covering can provide a coefficient of friction greater than 1. The covering can be made of ePTFE and can be a tube that covers the coil, and can be smooth or can have holes (or be woven or have other structural features that provide greater accessible surface area like holes) to facilitate tissue ingrowth. When the ePTFE tube is smooth, the covering can also have a PET weave on the ePTFE tube. The outermost surface of the covering or weave on the covering can be any biocompatible material that provides friction, such as a biocompatible metal, silicone tube, or PET. The hole size in the ePTFE can be in the range of 30 to 100 microns. In embodiments with a PET covering on top of the ePTFE, the PET layer can be attached only to the ePTFE covering and not directly to the coil of the docking device. The ePTFE tube covering can be attached to the docking device coil at the proximal and distal ends of the covering. The ePTFE tube covering can also be laser welded to the coil or forged to secure it in place to the coil, including using radiopaque markers placed outside of the ePTFE tube covering or PET weave as forging material.

[0283] The covering 1104 can be added to any docking device described herein and can cover all or a portion of the docking device. For example, the covering can be configured to cover only the functional coil, the guide coil, the stabilizing coil, or only a portion of one or more of these coils (e.g., only a portion of the functional coil).

[0284] FIGS. 14A-14CAn embodiment is shown that utilizes a smooth and / or soft cover 1200 on the core 1202 of the docking device to reduce friction while maintaining the holding force for the artificial valve. In some embodiments, the soft cover 1200 is expanded polytetrafluoroethylene (ePTFE), but other materials are also possible. FIG. 14A In the core 1202, the core is surrounded by two layers, which can be two layers of ePTFE. The outer layer 1204 can be low-density ePTFE, which allows the artificial valve to embed itself into the ePTFE, thereby providing retention force for the artificial valve. Additionally, the inner layer 1206 can be higher-density ePTFE, which prevents the ePTFE from breaking apart and clustering at the distal and proximal ends of the docking device during deployment (e.g., ...). FIGS. 9A-11C (Items 21 and 31). An exemplary low-density ePTFE can be approximately 0.2 g / cm³. 3 ePTFE. An exemplary higher-density ePTFE could be with a density of approximately 1.3 g / cm³. 3 1.4g / cm 3 1.5g / cm 3 1.6g / cm 3 1.7g / cm 3 1.8g / cm 3 1.85g / cm 3 Or 1.9g / cm 3 The ePTFE. In some embodiments using two layers of soft and / or smooth coverings, the core diameter will be approximately 0.84 mm (e.g., ±0.5 mm), while in some embodiments it will have a core diameter of at least 0.83 mm. Additionally, in some embodiments, the outer diameter of the inner layer 1206 will be approximately 1.34 mm (e.g., ±1 mm). Furthermore, the outer diameter of the outer layer 1104 will be 3.1 mm (e.g., ±1 mm). In some embodiments, the outer diameter of the outer layer 1204 will not exceed 3.1 mm.

[0285] In some embodiments, the soft and / or smooth covering utilizes a three-layer approach, such as... FIG. 14B As shown. In the three-layer example, the intermediate layer 1208 of ePTFE has an intermediate layer of ePTFE between the inner layer 1206 and the outer layer 1204. In some embodiments, the intermediate layer 1208 will utilize ePTFE having a higher density than the outer layer 1204 but a lower density than the inner layer 1206. For example, as FIG. 14B The three-layer embodiment shown can have approximately 0.2 g / cm³. 3 The outer layer of ePTFE is 1204, with a density of approximately 1.3 g / cm³. 3 Approximately 1.9 g / cm³ 3 The inner layer of ePTFE is 1206, and the density used is approximately 0.2 g / cm³. 3about 1.9 g / cm 3 In some embodiments using two layers of soft and / or smooth coverings, the core diameter will be about 0.84 mm (e.g., ± 0.5 mm), while some embodiments will have a core diameter of at least 0.83 mm. Additionally, the outer diameter of the inner layer 1206 of some embodiments will be about 1.34 mm (e.g., ± 1 mm). Also, the outer diameter of the middle layer 1208 of some embodiments will be about 1.62 mm (e.g., ± 1 mm), while the outer diameter of the outer layer 1204 will be 3.1 mm (e.g., ± 1 mm) in various embodiments. In some embodiments, the outer diameter of the outer layer 1204 will be no greater than 3.1 mm.

[0286] Some embodiments of ePTFE including multiple layers to form a soft and / or smooth covering will bond the layers together across the length of the covering and / or docking device. However, additional embodiments will use an intermittent bonding pattern to increase the tackiness of the covering, such as shown in FIG. 14C In FIG. 14C , the length of a docking device having a smooth and / or soft covering is shown. Bonding 1210 at various locations along the length of the soft covering 1200 is shown. In various embodiments, the distance between the bonding can be every 5 mm, 8 mm, or 12 mm. In some embodiments, the bonding can be at variable distances to adjust the properties along the length of the docking device.

[0287] The size and shape of the functional coil of the docking devices herein can be similar or the same, or can vary in size and / or shape. Turning to FIGS. 15A-15D , variations of the functional coil of the docking device 70 are shown. In FIG. 15A and FIG. 15B , the central region 80 has a generally hourglass shape in the functional coil, such that the functional coil has a larger inner diameter at the inflow portion 1302 and outflow portion 1304 of the central region 80, and a smaller inner diameter at the intermediate location 1306. Conversely, FIG. 15C and FIG. 15D show the central region 80 having a generally barrel shape, with a larger inner diameter at the intermediate location 1306, and a smaller inner diameter at the inflow portion 1302 (e.g., atrial or proximal) and outflow portion 1304 (e.g., ventricular or distal). FIGS. 15A-15D The hourglass and / or barrel design of

[0288] FIGS. 15A-15DThe hourglass and barrel shapes of the docking device can be formed in a variety of ways, including by forming the docking device 70 with a uniform cross-section from the proximal end 88 to the distal end 84, but the shape of the central region 80 maintains the hourglass or barrel shape as shown in FIGS. 15A-15D respectively. Another way to form these shapes is to vary the cross-section from the proximal end 88 to the distal end 84 such that the inner diameter in the central region 80 has the hourglass or barrel shape. Additionally, the number of functional coils can be increased to form FIG. 15A the hourglass or barrel shape. For example, some embodiments of the hourglass shape will utilize a 3-coil central region 80 (as shown in FIG. 15B ), with the distal-most and proximal-most functional coils having a larger inner diameter, and the middle coil having a relatively smaller inner diameter, while other embodiments can utilize a 5-coil central region 80 (as shown in FIG. 15C ), and still other embodiments will use 7 coils or more in the central region 80, with the inner diameter of the middle coils having a more gradual change between the larger diameters of the proximal-most and distal-most functional coils. Conversely, embodiments of the barrel shape will utilize a similar number of coils as described for the hourglass shape, including a 3-coil version FIG. 15D ), a 5-coil version FIG. 16 , or 7 coils or more; however, it should be noted that the barrel shape will increase the inner diameter of the middle coils relative to the distal-most and proximal-most functional coils. Furthermore, these examples of 3-coil, 5-coil, and 7-coil are for illustration only, and should not be interpreted as limiting the number of coils to an odd number of coils, nor to only these examples.

[0289] In some embodiments, the docking devices herein can further incorporate flanges 1402 on the stabilizing coils of the docking device 70, for example as shown in FIG. 16 . In FIGS. 12A-16 , the stabilizing coils 86 have a piece of cloth or other fabric connected to the next adjacent turn 1404 in the central region 80. This piece of cloth will act as a flange 1402 to reduce paravalvular leakage and / or increase the amount of blood flowing through the prosthetic valve.

[0290] In some embodiments, the various docking devices described herein include one or more transmissive markers along the length of the docking device. For example, transmissive markers may be placed at the distal end in some embodiments, and some embodiments include transmissive markers at a location approximately one-quarter turn of the coil passing through the docking device. Additional embodiments include multiple transmissive markers located throughout the docking device. For example, transmissive markers may be placed every 25 mm, 29 mm, 30 mm, 34 mm, or further, which medical professionals can use to identify the amount of expansion of the functional turn diameter, such as when an artificial valve is subsequently deployed in the docking device. The transmissive marker strips may be laser-welded to the coil, or the transmissive markers may be placed on the outside of an ePTFE tube cover or PET fabric and then forged into the material to secure it in place to the coil.

[0291] It should be noted that various embodiments will include several features, such as references FIGS. 15A-15D The features described herein, and all combinations of these features considered herein, are excluded unless some features are mutually exclusive and / or physically incompatible (e.g., having...). Delivery system (Hourglass and barrel-shaped docking devices). Additionally, although the terms stabilizing coil / turn and atrial coil / turn are used together or interchangeably herein, it should be noted that docking devices can also be used in other locations where a similar shape would be advantageous, and the use of these terms does not imply limitation of the embodiments described herein to atrial deployment.

[0292] FIGS. 9A-16

[0293] Some embodiments involve anchoring elements / docking devices (such as those referenced above) FIG. 24B The described docking device is a delivery system and / or device for delivering one of the docking devices to the heart and / or natural valves of an animal, human, or cadaver, a cadaveric heart, an anthropomorphic phantom, and / or a simulation / simulator. Such devices include transcatheter devices that can be used to guide the delivery of the docking device through a vascular system.

[0294] exist FIGS. 9A-16 An exemplary delivery system 2220 configured to deliver a docking device 2232 to a target implantation site is illustrated. In some embodiments, the docking device 2232 may be as described above. FIG. 24B One of the described docking devices. The delivery system may include a handle assembly 2200 and an outer shaft (e.g., a delivery conduit) 2260 extending distally from the handle assembly 2200. The handle assembly 2200 may include a handle 2222, which includes one or more knobs, buttons, wheels, or the like. For example, in some embodiments, such as FIG. 24BAs shown, handle 2222 can include knobs 2224 and 2226, which can be configured to control flexing of the delivery system (e.g., outer shaft 2260). Further details regarding delivery systems configured to deliver docking devices to target implant sites, such as delivery system 2220, can be found in U.S. Patent Publication Nos. US 2018 / 0318079, US 2018 / 0263764, and US 2018 / 0177594, all of which are incorporated herein by reference in their entireties.

[0295] During delivery of certain docking devices at a target implant site, there is a risk that the docking device will become captured, caught, and / or obstructed by natural portions of the anatomy, such as on the heart wall, trabeculae, native leaflets, chordae tendinae, etc., due to a variety of factors, such as friction against the natural anatomy, catching of the distal or terminal end in trabeculae and / or chordae, size difference between the inner diameter of the functional turn of the docking device and the outer diameter of the native leaflet, etc. Some docking devices have a braided or woven texture and / or covering on the surface of the docking device to increase friction. This friction can make it difficult to advance the docking device around this natural anatomy. Furthermore, the diameter of the native leaflet can be as high as about 55 mm, while the functional turn of the docking device is typically designed to be much smaller (e.g., as low as about 22 mm). When the functional turn of the docking device is small, the native leaflet can push out over the docking device, increasing the frictional force between the native leaflet and the docking device.

[0296] Once the docking device encounters such an obstacle, the physician, surgeon, or other medical professional can need to retract the docking device into the delivery system (e.g., catheter-based device) and then attempt to deploy the docking device again. This trial-and-error approach can result in damage to the native tissue due to the texture or weave present on the docking device rubbing against and / or capturing portions of the tissue and dragging them back into the catheter-based delivery system, which can damage or obstruct the catheter-based delivery system. Furthermore, this can extend the amount of time of the deployment procedure.

[0297] To overcome these challenges, it is desirable to provide a docking device that has a lubricated outer surface (e.g., such as on the functional turn and / or other portions), but once properly positioned and during subsequent deployment of the prosthetic valve therein, also has a higher friction functional coil / turn. In some embodiments, this is achieved through a temporary lubricated sleeve or sheath that can be placed over the docking device during delivery and can be retracted from the docking device after the docking device is in the desired location / site. In some embodiments, the lubricated or low-friction sleeve / sheath can be incorporated into the transvascular and catheter-based delivery systems, such as FIG. 24B delivery system 2220 of U.S. Patent Publication No. US 2018 / 0318079.

[0298] Embodiments of delivery systems including a lubricating sleeve, such as delivery system 2220, can include one, some, or all of the following features: a kink-resistant sleeve that is permanently lubricated, capable of withstanding multiple cycles of repositioning (e.g., greater than 30 cycles); a sleeve that can be simultaneously advanced into the anatomy with the docking device but moved independently of the docking device and pushrod shaft of the delivery system; a sleeve that more easily loops around the mitral valve leaflets and reduces the risk of damaging the mitral valve anatomy; a sleeve that can be retracted prior to releasing the docking device without affecting the position of the docking device; a sleeve that does not significantly increase the length of the delivery system and / or the cross-section of the docking device; a sleeve that does not increase the deployment force or retraction force of the docking device; a sleeve that is ergonomic and does not significantly increase the number of procedural steps or include simultaneous steps; a delivery system that allows continuous flushing of the sleeve lumen and the sleeve outer lumen to avoid thrombus formation; and a sleeve that has radial strength to compress a paravalvular leak solution (e.g., a foam or a weave as described above) on the docking before retracting the sleeve. To include a retractable sleeve for covering the docking device, certain embodiments include two primary shafts for delivering the docking device that can be actuated independently of one another: a pushrod shaft that pushes the docking device into place; and a sleeve shaft that actuates a lubricating sleeve around the docking device in a manner that minimizes the increase in the outer diameter of the delivery system. In many embodiments, the two shafts extend coaxially inside the delivery catheter.

[0299] For example, in some embodiments, the delivery system 2220 can include a pushrod shaft 2238 and a sleeve shaft (not visible in FIG. 24B ) coaxially located within an outer shaft 2260, and each shaft has a portion that extends into the handle assembly 2200. The pushrod shaft 2238 can be configured to deploy the docking device 2232 from inside a distal portion of the outer shaft 2260 when the target implant site is reached, and the sleeve shaft can be configured to cover the docking device while inside the delivery system 2220 and while implanted at the target implant site. Further, the delivery system 2220 can be configured to adjust the axial position of the sleeve shaft to remove the sleeve portion (e.g., distal segment) of the sleeve shaft from the docking device 2232 after implantation at the target implant site, as further explained below. As shown in FIG. 24A , during delivery, the docking device 2232 can be coupled to the delivery system via a release suture 2236 (or other retrieval line including a wire, yarn, or other material that can be configured to be tied around the docking device and cut away) that extends through the pushrod shaft 2238. As further explained below with reference to FIGS. 27A-30C and FIG. 24A , the release suture 2236 can extend through the delivery system 2220, through an inner lumen of the pushrod shaft 2238, to a suture lock assembly 2206 of the delivery system 2220. As further explained below with reference to FIGS. 17A-23B , FIGS. 33-34and FIG. 24B Let's discuss more details about the pushrod shaft and sleeve shaft.

[0300] The handle assembly 2200 may further include a hub assembly 2230 having a suture locking assembly (e.g., a suture lock member) 2206 and a sleeve handle 2234 attached thereto. The hub assembly may be configured to control the push rod shaft and sleeve shaft of the delivery system 2220, while the sleeve handle 2234 may control the position of the sleeve shaft relative to the push rod shaft. In this way, operation of the various components of the handle assembly 2200 can actuate and control the operation of components arranged within the outer shaft 2260. In some embodiments, the hub assembly 2230 may be coupled to the handle 2222 via a connector 2240.

[0301] The handle assembly 2200 may further include one or more flushing ports to supply flushing fluid to one or more lumens disposed within the delivery system 2220 (e.g., annular lumens disposed between coaxial components of the delivery system 2220) to reduce potential thrombosis. FIG. 24A The image shows one embodiment of the delivery system 2220 including three flushing ports (e.g., flushing ports 2210, 2216, and 2218). Further details of these flushing ports and the components of the handle assembly 2200 are referenced below. Sleeve shaft discuss.

[0302] FIGS. 17A-20D

[0303] exist FIG. 24B The image shows an example sleeve shaft 1500 according to various embodiments, which can be used in docking device delivery systems (such as...) FIG. 17A This is implemented within the delivery system 2220. Other variations of the sleeve shaft, having only some of the features shown in these figures and / or additional features not shown, are also possible. In some embodiments, such as FIG. 24A As shown, the sleeve shaft 1500 includes three sections: a distal or sleeve section 1502, which includes a lubricating sleeve covering the docking device during deployment; a proximal section 1504, which is used for actuating or moving the sleeve position; and an intermediate section 1506 connecting the distal section 1502 and the proximal section 1504. A portion of the proximal section 1504 may be arranged in the handle assembly (see reference below). FIGS. 35-37 and FIG. 17D (To be discussed further). Furthermore, sections 1502, 1504, and 1506 of the sleeve shaft 1500 can be formed from various components and / or materials, including a flexible polymer sheath 1516 (…). FIG. 17E ), more rigid pipe 1530 ( FIG. 17B Lining 1540 ( FIG. 17C , FIG. 19 ,FIG. 20C and FIG. 17D The sleeve shaft 1500 may include a distal segment 1502 and a middle segment 1506, and a liner 1540 may extend along and form the inner surfaces of the distal segment 1502 and the middle segment 1506, and a tube 1530 may form a proximal segment 1504, a portion of which extends into the proximal portion of the middle segment 1506. In this way, each of the distal segment 1502, proximal segment 1504, and middle segment 1506 of the sleeve shaft 1500 may comprise different layers and material compositions, as further explained below.

[0304] Because the distal segment 1502 is configured to cover the docking device, the distal segment in various embodiments can be flexible, have a low durometer (e.g., hardness), and have a hydrophilic coating. In some embodiments, the hydrophilic coating acts as a lubricating surface to improve ease of surrounding the natural anatomy, reduce the risk of damage to the natural anatomy, and reduce procedure time. A lubricating sleeve can cover higher friction areas of the docking device during implantation. Additionally, as described above, the distal segment 1502 can serve as a cover for perivalvular leakage schemes that may exist on the docking device, such as foam or fabric. Because the distal segment 1502 serves as a sleeve or cover for the docking device, in many embodiments it can be formed into a tubular structure (e.g., as shown in the image). FIG. 17B As shown, and discussed further below). The tubular structure includes an inner diameter sufficient to surround the docking device and an outer diameter not much larger than the diameter of the docking device. For example, in some embodiments, the inner diameter of the distal portion 1502 of the sleeve shaft 1500 is approximately 2.4 mm (e.g., ±0.3 mm), while the outer diameter is approximately 3.4 mm (e.g., ±0.5 mm). In some embodiments, the inner diameter is 2.4 mm ±0.1 mm, while the outer diameter is 3.4 mm ±0.2 mm. Furthermore, in some embodiments, the length of the distal portion 1502 is sufficient to cover the entire length of the docking device from its distal end to its proximal end. In some embodiments, the distal portion 1502 will be longer than the docking device to allow some space to cover the connection area of ​​the docking device or to provide additional space for increased flexibility or any other reasonable purpose. For example, in some embodiments, during delivery, the distal end (or tip) 1512 of the distal portion 1502 may extend beyond the distal end of the docking device (in FIG. 33The designation is 1514; however, in an alternative embodiment, the distal end of the docking device may be located further from the distal end 1512, thereby providing a more non-invasive end to the distal segment 1502 of the sleeve shaft 1500, which may be bent, compressed, deformed, or otherwise shaped as it navigates around the natural structure of the implantation site of the docking device. This is referred to below. FIG. 18 Further explanation. In some embodiments, the length of the distal segment 1502 will be approximately 400 mm (e.g., ±10 mm). In some embodiments, the length of the distal segment 1502 may be in the range of 385 mm to 415 mm.

[0305] like FIG. 19 As shown, in some embodiments, the distal segment 1502 includes a plurality of different components. In some embodiments, the distal segment 1502 is constituted by a flexible polymer 1602 on a supporting fabric 1604. The flexible polymer 1602 (which may be part of a polymer sheath 1516) may be selected from a variety of elastomeric materials, while the fabric needs to be supportive and flexible, including high-density fabrics (measured in picks per inch; for example, 80 ppi, 90 ppi, or the like). In some embodiments, the fabric 1604 may be constructed of metal such as nitinol or stainless steel. In some embodiments, the fabric 1604 may be a stainless steel fabric with a density of about 90 ppi. In some embodiments, the flexible polymer may be a polyether-amide block copolymer or a blend of two or more polyether-amide block copolymers. The flexible polymer may have a Shore D hardness measured according to ISO 868:2003, which is between about 20 and about 40, between about 20 and about 30, about 22, or about 25. In some embodiments, the flexible polymer may have a flexural modulus measured according to ISO 178:2010, which is between about 10 MPa and about 80 MPa, between about 10 MPa and about 25 MPa, between about 10 MPa and about 20 MPa, between about 10 MPa and about 15 MPa, between about 10 MPa and about 12 MPa, about 10 MPa, about 11 MPa, about 12 MPa, about 13 MPa, about 14 MPa, or about 15 MPa. In some embodiments, the flexible polymer may be... Classes 2533, 3533, 4033, 4533, 4533 and 5513 (Arkema SA, France) and A blend of one or more of the following: Grade E40 (Evonik Industrial AG, Germany). In some embodiments, the flexible polymer may be... 2533.

[0306] Additional embodiments of the distal section 1502 can include an inner layer (e.g., an inner liner) 1606 to provide against an inner layer of the docking device (which can be part of the inner liner 1540), which can be made of various polymeric materials such as PTFE. Finally, in some embodiments, a hydrophilic coating 1608 such as a hydrogel is applied on the outside of the sleeve if the flexible polymer 1602 is not sufficiently lubricious. The hydrophilic coating can serve various purposes such as allowing the docking device with the sleeve to navigate more easily around native valve anatomy without significant friction. Additionally, the hydrophilic compound increases echogenicity, so the sleeve can be visualized using ultrasound. Furthermore, the distal section 1502 of some embodiments can include radiopaque material to increase the ability to visualize the sleeve during deployment of the docking device, as described in more detail below with reference to FIGS. 18-20. FIG. 18 Further described.

[0307] Although FIG. 17B One exemplary construction of the distal section 1502 is shown, but other embodiments can utilize a cut (such as laser cut) higher durometer material. In such laser cut and higher durometer material embodiments, the cut can allow the distal section 1502 to be more pliable and flexible, while the higher durometer material can provide integrity to the distal section.

[0308] Additionally, the distal section 1502 of the sleeve shaft 1500 of various embodiments includes a distal tip 1520, as FIG. 19 shown and described in more detail in FIG. 19 If the distal tip 1520 contacts an obstruction, the distal tip 1520 can incorporate a thinner and / or softer material to help deflect the sleeve. In some embodiments, the distal tip 1520 is also tapered such that it has a smaller diameter at its distal tip 1512. As FIG. 19 shown in FIG. 17, in some embodiments, the inner liner 1540 can not extend to the distal end 1512, such that the distal end portion of the distal tip 1520 is composed only of the flexible polymer (e.g., the flexible polymer material of the polymer jacket 1516). Furthermore, several embodiments incorporate radiopaque material in the distal tip 1520 to increase the visibility of the distal tip 1520 of the sleeve shaft 1500 during deployment from the delivery system (e.g., at the target implant site). In some embodiments, as FIG. 19 shown in FIG. 18, the radiopaque material can be in the form of one or more marker bands 1552, which are embedded within the polymer jacket 1516 and spaced apart from the distal end 1512. In some embodiments, the metal braid or woven portion of the polymer jacket 1516 can terminate a distance before the distal end of the marker bands 1552, such as in the range of 1-5 mm, 2-4 mm, 3 mm, or other distance. FIG. 17Dposition 1554 as shown in FIG. 15. In some embodiments, the radiopaque material of the marker band 1552 is platinum-iridium marker, while other embodiments will utilize a portion of a flexible polymer loaded with bismuth or BaS04, 60% BaS04.

[0309] The middle section 1506 of the sleeve shaft 1500 of various embodiments is used to provide column strength to push and retract the distal section 1502 with the docking member after the docking device is wrapped around the native valve anatomy and navigates the patient's anatomy from the point of insertion of the delivery system to the heart. Thus, the middle section 1506 of various embodiments can be both flexible and have a woven polymer shaft. Additionally, in some embodiments, the middle section 1506 can comprise a flexible polymer with a varying durometer along its length, as described further below with reference to FIGS. 16A-16C. FIG. 17D The middle section 1506 of many embodiments can be constructed from a flexible polymer on a support weave. In certain embodiments, the flexible polymer can be a polyether-amide block copolymer or a blend of two or more polyether-amide block copolymers. The flexible polymer can have a Shore D hardness, measured according to ISO 868:2003, of between about 35 and about 70, between about 45 and about 65, between about 50 and 60, or about 55. In some embodiments, the flexible polymer can have a flexural modulus, measured according to ISO 178:2010, of between about 75 MPa and about 400 MPa, between about 100 MPa and about 250 MPa, between about 150 MPa and about 200 MPa, between about 160 MPa and about 180 MPa, between about 160 MPa and about 170 MPa, about 160 MPa, about 165 MPa, about 170 MPa, about 175 MPa, about 180 MPa, or about 185 MPa. In certain embodiments, the flexible polymer can be grades 4033, 4533, 5533, 6333, 4533, and 7033 (Arkema S.A., France) and grades E40, E47, E55, E58, and E62 (Evonik Industries AG, Germany) or a blend of two or more. In some embodiments, the flexible polymer can be 5533. In other embodiments, the flexible polymer can be E55. The braid can be a braid having the same density as the distal section 1502 (e.g., 80 ppi, 90 ppi, or the like) or having a lower density (e.g., 60 ppi). Additionally, in some embodiments, the intermediate section 1506 is a tubular structure adapted and / or configured to enable the sleeve shaft to be operable on the pushrod shaft. As a tubular structure, the inner diameter can be about 2.25 mm (e.g., ± 0.3 mm) while the outer diameter is about 3.0 mm (e.g., ± 0.5 mm). In some embodiments, the inner diameter is 2.21 mm while the outer diameter is 3.07 mm. In various embodiments, the length of the intermediate section will be sufficient to navigate through the patient’s anatomy. In many embodiments, the length of the intermediate section will be about 940 mm (e.g., ± 50 mm).

[0310] In some embodiments, the distal section 1502 and the intermediate section 1506 are formed as a single continuous unit having varying properties (e.g., size, polymer, braid, etc.) along the length of the single unit. For example, FIG. 17D An exemplary embodiment of a flexible polymer jacket (or covering) 1516 and its relative position on the above-described sections of the sleeve shaft 1500 is shown. The polymer jacket 1516 can be included on and / or at least partially form the distal section 1502 and the intermediate section 1506 of the sleeve shaft 1500. FIG. 17D The dashed line in FIG. 15A shows the proximal section 1504 of the sleeve shaft 1500, which does not include the flexible polymer jacket. In some embodiments, as described above, the polymer jacket 1516 can include the same flexible polymer (e.g., ) of different grades or durometers along its length. In other words, the polymer jacket 1516 can have varying (e.g., increasing) durometers (also referred to as Shore durometers) along its length from its distal end 1518 to its proximal end 1522.

[0311] As an example, the distal section 1502 can include a flexible polymer (e.g., The possible grades and Shore D hardness of the distal segment 1502 have been discussed above. The portion of the polymer sheath 1516 forming the intermediate segment 1506 may include: a first portion 1524 comprising the same flexible polymer having a second hardness greater than the first hardness of the distal segment 1502 (e.g., less flexible); and a second portion 1526 comprising the same flexible polymer having a third hardness greater than the second hardness (e.g., less flexible). The possible grades and Shore D hardness of the intermediate segment 1506 have been discussed above. In some embodiments, the first hardness may be about 20 to about 24, the second hardness may be about 50 to about 60, and the third hardness may be about 55 to about 65. Thus, the polymer sheath 1516 may increase in hardness and decrease in flexibility towards its proximal end 1522. In alternative embodiments, the polymer sheath 1516 may include a higher hardness than... FIGS. 9A-11C The diagram shows segments with varying hardness. For example, in some embodiments, the portion forming the intermediate segment 1506 of the polymer sheath 1516 may include two or more segments with different hardnesses (e.g., three segments, each with a different hardness).

[0312] In some embodiments, the liner 1540 may be disposed along the inner surface of the polymer sheath 1516 in the distal segment 1502 and the intermediate segment 1506. As described above, in some embodiments, the liner 1540 may comprise a thin layer of polymer (such as PTFE). The polymer materials of the inner layer 1540 and the polymer sheath 1516 may be configured to bond to each other.

[0313] The proximal section 1504 of the sleeve shaft is designed to be more rigid and provides column strength for use with a mating device (e.g., mating device 70, such as...). FIGS. 21A-21G (As shown) the middle section 1506 and the distal section 1502 are pushed, and the distal section 1502 is retracted after the docking device surrounds the natural anatomical structure to actuate the position of the lubrication sleeve. When the sleeve shaft 1500 of various embodiments surrounds the push rod shaft (e.g., as further described below) FIG. 17E When the push rod shaft 1900 is in operation, this structure can be shaped and configured as a generally tubular structure and is more rigid. For example, the proximal section 1504 can be formed from a relatively rigid tube 1530, such as FIG. 17E As shown. In some embodiments, tube 1530 may be constructed of a surgical-grade metal such as stainless steel. In some embodiments, tube 1530 may be a thiocyanate tube.

[0314] The tube 1530 may include a first segment 1532 (which may form the entirety of the proximal segment 1504) and a second segment 1534, the second segment 1534 extending into the intermediate segment 1506 (see...).FIG. 20B and FIG. 24A As further explained below, the first section 1532 includes a cut portion 1508 that is not a complete circle in cross-section (in a plane orthogonal to the central longitudinal axis 1501 of the sleeve shaft 1500) (e.g., is open and does not form a closed tube). The remainder of the tube 1530 can be tubular (e.g., a closed tube with a relatively circular cross-section). As further explained below, the second section 1534 can be configured to facilitate bonding between an inner liner 1540 disposed on an inner surface of the second section 1534 and a polymer jacket 1516 disposed on an outer surface of the second section 1534.

[0315] As a tubular structure, the tube 1530 of various embodiments can have an inner diameter of about 2.4 mm (e.g., ± 0.3 mm), while an outer diameter can be about 3.0 mm (e.g., ± 0.5 mm). In some embodiments, the inner and outer diameters of the tube 1530 can vary over the length of the tube 1530. For example, in some embodiments, the proximal end 1536 of the tube 1530 can have an inner diameter of 2.21 mm (± 0.02 mm) and an outer diameter of 3.07 mm (± 0.02 mm). In some embodiments, the distal end 1538 of the tube 1530 can have an inner diameter of 2.67 mm (± 0.3 mm) and an outer diameter of 2.87 mm (± 0.3 mm).

[0316] As noted above, the first section 1532 of the tube 1530 can include a cut portion 1508 proximal to the proximal end 1536. As further explained below, the cut portion 1508 can be configured to allow the proximal extension 1910 of the push rod shaft 1900 to extend out of a void space 1544 formed in the cut portion 1508 (e.g., to extend out of the cut portion 1508) and to diverge at an angle relative to the cut portion 1508 into a branch 2204 of the hub assembly 2200 (e.g., the suture lock 2206 can be connected at one end of the branch 2204, as shown below). FIG. 35 , FIG. 36 and FIG. 20A As shown in FIGS. 15A-15C, the cut portion 1508 of the sleeve shaft 1500 extends into the hub assembly 2200 of the handle assembly 2200, and a portion of the push rod shaft 1900 (e.g., the proximal extension 1910) extends along the inner surface of the cut portion 1508. The cut (e.g., open) profile of the cut portion 1508 can allow the proximal extension 1910 of the push rod shaft 1900 to extend out of a void space 1544 formed in the cut portion 1508 (e.g., to extend out of the cut portion 1508) and to diverge at an angle relative to the cut portion 1508 into a branch 2204 of the hub assembly 2200 (e.g., the suture lock 2206 can be connected at one end of the branch 2204, as shown in FIG. 15C). FIG. 20B and FIG. 24A As shown in FIGS. 15A-15C, the cut portion 1508 of the sleeve shaft 1500 extends into the hub assembly 2200 of the handle assembly 2200, and a portion of the push rod shaft 1900 (e.g., the proximal extension 1910) extends along the inner surface of the cut portion 1508. The cut (e.g., open) profile of the cut portion 1508 can allow the proximal extension 1910 of the push rod shaft 1900 to extend out of a void space 1544 formed in the cut portion 1508 (e.g., to extend out of the cut portion 1508) and to diverge at an angle relative to the cut portion 1508 into a branch 2204 of the hub assembly 2200 (e.g., the suture lock 2206 can be connected at one end of the branch 2204, as shown in FIG. 15C). FIG. 20A As such, the push rod shaft 1900 and the sleeve shaft 1500 can operate parallel to one another, and the overall length of the delivery system in which the sleeve shaft 1500 and the push rod shaft 1900 are incorporated can be kept similar or only slightly longer than previous delivery systems that did not incorporate a sleeve.

[0317] In some embodiments, the cut portion 1508 can have a generally U-shaped cross-section, where a portion of the entire tubular structure is removed. For example, the cut portion 1508 can form an open passageway or channel. In various embodiments, a laser can be used to cut the cut portion 1508, although any other means for removing a portion of the tubular structure can be used. Example embodiments of the shape of the cut portion 1508 can be seen in FIG. 20B and FIG. 20A However, in alternative embodiments, different portions of the perimeter of the tube 1530 can be removed / cut to form the cut portion 1508 as compared to that shown in FIG. 20B and FIG. 20A

[0318] An end face 1545 (e.g., exposed) is formed (e.g., at the interface between the cut portion 1508 and the remainder of the first section 1532) on the entire tubular portion of the first section 1532. The end face 1545 can be disposed normal to the longitudinal center axis 1501 and can be configured to share contact with the face of a stop element (e.g., plug 1906) of a push rod shaft (e.g., as shown in FIG. 20B and FIG. 22B The end face 1545 can be disposed normal to the longitudinal center axis 1501 and can be configured to share contact with the face of a stop element (e.g., plug 1906) of a push rod shaft (e.g., as shown in FIG. 17E as further explained below).

[0319] As shown in FIG. 20C the second section 1534 of the tube 1530 can include a plurality of apertures 1546 configured to enable the coupling of a proximal end of a second portion 1526 of a polymer jacket 1516 disposed on an outer surface of the second section 1534 to an inner liner 1540 disposed on an inner surface of the second section 1534. For example, as shown in FIG. 20C the inner liner 1540 can extend along the inner surface of the second section 1534 to an edge 1556 of the second section 1534 that forms the interface between the first section 1532 and the second section 1534 of the tube 1530. However, in FIG. 20D the inner liner 1540 and the second section 1534 of the tube 1530 are not coupled together. As shown in FIG. 20D the polymer jacket 1516 can be backflowed on the outer surface of the second section 1534 and coupled to the inner liner 1540 through the apertures 1546. Thus, in FIG. 17E the second section 1534 of the tube 1530 is sandwiched between the polymer jacket 1516 and the inner liner 1540.

[0320] ​For example, the polymers of the outer jacket 1516 and the inner liner 1540 can not be able to bond (e.g., adhere) directly to the material (e.g., metal) of the tube 1530, but can bond to each other. Thus, the size and shape of each aperture 1546 and the relative arrangement of the apertures 1546 on the second section 1534 can be selected to allow the outer polymer jacket 1516 to be securely bonded to the inner liner 1540 through the second section 1534 of the tube 1530 arranged between the outer polymer jacket 1516 and the inner liner 1540. In this way, the tube 1530 can be fixed to the polymer jacket 1516 and the inner liner 1540.

[0321] In some embodiments, each of the plurality of apertures 1546 can extend through the entire thickness of the tube 1530. In some embodiments, the apertures 1546 can be formed as through holes (e.g., through apertures) that are punched or cut through the entirety of the second section 1534 of the tube 1530. In this way, in some embodiments, at each axial location of one of the visible apertures 1546, another aperture 1546 can be positioned 180 degrees around the perimeter of the tube 1530 from the visible aperture 1546. For example, as shown in FIG. 15B, the second section 1534 can include 28 apertures 1546, with adjacent groups of apertures 1546 offset 90 degrees from each other. FIG. 17E FIG. 17E In some embodiments, along the length of the second section 1532, in the axial direction, the apertures can be spaced apart from each other by a first (center-to-center) distance 1548, and each group of apertures 1546 at the same axial location can be spaced apart from an adjacent group of apertures 1546 by a second distance 1550. In some embodiments, the first distance 1548 is about 3 mm, and the second distance 1550 is 1.5 mm. In some embodiments, the first distance 1548 is in the range of 2.5 mm to 3.5 mm, and the second distance 1550 is in the range of 1.0 mm to 2.0 mm. In some embodiments, the second distance 1550 is half of the first distance 1548. In alternative embodiments, different numbers of apertures 1546 and / or relative spacing and arrangement between the apertures 1546 than shown above and described above are possible while still providing sufficient bonding between the inner liner 1540 and the polymer jacket 1516. FIG. 17C

[0322] ​​In some embodiments, the orifices 1546 can be circular with a diameter in the range of 0.5 to 1.5 mm, 0.8 mm to 1.2 mm, or 0.95 to 1.05 mm. In some embodiments, the diameter of the orifices 1546 can be approximately 1.0 mm. In some embodiments, the orifices 1546 can have another shape, such as an oval, square, rectangle, star, triangle, or the like. The diameter or width of each orifice 1546 can be selected so that the flexible polymeric sheath 1516 can backflow over the outer surface of the tube 1530, flow into the orifices 1546, and bond securely to the inner liner 1540 disposed on the inner surface of the tube 1530 at the interface between the middle section 1506 and the proximal section 1504, as FIG. 20A shown in the detail view 1510.

[0323] In some embodiments, as FIGS. 21A-21G shown, a grommet 1804 can be located within the tubular portion of the distal portion 1504 of the sleeve shaft 1500 to form a seal between the sleeve shaft 1500 and a push rod shaft (e.g., a push rod shaft 1900 as Pusher shaft shown, as further explained below) that extends through the sleeve shaft 1500. According to some embodiments, the seal formed by the grommet 1804 is to prevent fluid from being flushed through the delivery system to backflow or find a lower resistance path than intended through another lumen, as further explained below.

[0324] FIGS. 21A-21G

[0325] Examples of push rod shafts 1900 that can be used in a delivery system of a docking device, such as the delivery system 2220 of FIGS. 23A-23B and FIG. 24B are shown in accordance with various embodiments. FIG. 21A FIG. 21B shows four main components of the push rod shaft 1900, while FIG. 21C shows a more detailed embodiment of the push rod shaft 1900. A side view of an exemplary distal end of the push rod shaft 1900 is shown in FIG. 21D , and a proximal end view of the push rod shaft 1900 is shown in FIGS. 21E-21G . FIG. 21E shows some individual components of the push rod shaft 1900, including a main tube (which can be a hypotube in some embodiments) 1902 FIG. 21F , an outer shell 1904 FIG. 21G , and a plug 1906 FIGS. 23A-23B . FIGS. 22A-22C ​A view of a portion of the push rod shaft 1900 is shown, in which the housing 1904, the main tube 1902, and the proximal extension 1910 of the push rod shaft 1900 engage / interface with each other. These figures of the push rod shaft 1900 show a central longitudinal axis 1901, which can be coaxial with the central longitudinal axis 1501 of the sleeve shaft 1500 and the outer shaft 2260 of the delivery system, as shown in the following references. FIGS. 21A-21G Further explanation.

[0326] like FIGS. 23A-23B As shown, the example push rod shaft 1900 may include four sections or components: a main tube (e.g., a shaft) 1902 for advancing and retracting the docking device (such as one of the docking devices described herein) and housing a release suture that secures the docking device to the push rod shaft; a housing 1904; a housing 1904 that surrounds the push rod shaft 1900 and allows locking of the shaft and provides a hemostatic seal on the push rod shaft without interfering with the movement of the sleeve shaft; a plug 1906 that connects the main tube 1902 to the housing 1904 and serves as a stop for the sleeve shaft; and a proximal extension 1910 (e.g., FIG. 24B As shown in the best embodiment, it allows the push rod shaft to extend from the inside of the sleeve shaft to the outside of the sleeve shaft, thereby allowing the two shafts to be actuated in parallel and reducing the overall length of the delivery system.

[0327] The supervisor 1902 can be delivered from the outer axis of the delivery system (e.g., FIG. 24A The distal end of the outer shaft 2260 shown extends to the handle assembly of the delivery system (e.g., FIG. 24B and FIG. 35 In the handle assembly 2200). For example, as FIG. 36 and FIG. 21A As shown, and further described below, the proximal portion 1912 of the push rod shaft 1900 includes the interface between the main tube 1902, the housing 1904, the plug 1906, and the proximal extension 1910 (e.g., FIG. 21B , FIG. 21D and FIG. 21E As shown in the diagram, the proximal portion 1912 of the push rod shaft 1900 can be arranged within or near the hub assembly of the handle assembly (e.g., hub assembly 2230). Thus, the main tube 1902 can be an elongated tube extending along most of the delivery system.

[0328] In some embodiments, the main tube 1902 can be a hypotube. Hypotubes are can be used to deploy components of a docking device, and have been previously described in U.S. Patent Publication No. 2018 / 0318079, entitled “Deployment systems, tools, and methods for delivery an anchoring device for a prosthetic valve,” the entire disclosure of which is incorporated herein by reference in its entirety. In some embodiments, the main tube 1902 can comprise a biocompatible metal, such as stainless steel.

[0329] In various embodiments, the main tube 1902 (which is shown in more detail in FIG. 21E FIG. 19B) is a relatively rigid tube that provides column strength for actuating deployment of a docking device. The main tube 1902 can have a distal end 1914 at a point of interface with a docking device and a proximal end 1916 to which a proximal extension 1910 is attached (as discussed further below).

[0330] In some embodiments, as shown in FIG. 21E FIG. 19B, the main tube 1902 can have a distal section 1918 in which a plurality of cuts 1920 are included, which provide increased flexibility of the main tube 1902 out of its distal end. Thus, the distal section 1918 can be referred to as a flexible section or portion of the main tube 1902. In some embodiments, the cuts 1920 can be laser cuts formed by laser cutting into a surface (e.g., an outer surface) of the main tube 1902. In alternative embodiments, the cuts 1920 can be another type of cut formed by another cutting process (e.g., into an outer surface of the main tube 1902 via etching, scoring, through-cutting, etc.). The width and depth of the cuts 1920 can be configured to increase the flexibility of the main tube 1902. In some embodiments, each cut 1920 can be a through-cut that penetrates the entire main tube 1902 (e.g., from one side to the other in a direction perpendicular to the central longitudinal axis 1901). In some embodiments, the width of each cut 1920 can be approximately 0.05 mm. In some embodiments, the width of each cut 1920 can be in a range of 0.03 mm to 0.08 mm.

[0331] In some embodiments, the spacing between adjacent cuts 1920 can vary along the length of the distal section 1918. For example, as shown in FIG. 21EAs shown, adjacent cuts 1920 can be arranged closest together at the distal end 1914, and the spacing between adjacent cuts 1920 can increase from the distal end 1914 to the proximal end of the distal segment 1918. In some embodiments, the cuts 1920 can be formed as a spiral that cuts into (and through) the outer surface of the distal segment 1918 of the main tube 1902. Therefore, in these embodiments, the spacing or distance between adjacent cuts 1920 can be defined as the pitch of the cuts. In exemplary embodiments, as... FIG. 21E As shown, the first portion 1922 of the distal segment 1918 may have a spacing in the range of 0.4 mm to 0.64 mm, the second portion 1924 of the distal segment 1918 may have a spacing in the range of 0.64 mm to 1.2 mm, the third portion 1926 of the distal segment 1918 may have a spacing of 1.2 mm, and the fourth portion 1928 of the distal segment 1918 may have a spacing in the range of 1.2 mm to 3.0 mm. In some embodiments, the spacing of the first portion 1922 may increase along its length from 0.4 mm (at its distal end 1914) to 0.64 mm, the spacing of the second portion 1924 may increase along its length from 0.64 mm to 1.2 mm, the spacing of the third portion 1926 may be approximately 1.2 mm along its length, and the spacing of the fourth portion 1928 may increase along its length from 1.2 mm to 3.0 mm. It should be noted that the aforementioned spacing value of the distal segment 1918 is exemplary, and other spacings are also possible, wherein the spacing value can be selected to give the main tube 1902 increased flexibility at its distal end 1914 and decreased flexibility along the length of the distal segment 1918. In this way, the distal segment 1918 can be configured to flex and / or bend together with the outer axis 2260 of the delivery system as the delivery system navigates through the patient's internal lumen to reach the target implantation site.

[0332] In some embodiments, the main tube 1902 may include one or more portions or segments, each including a plurality of orifices 1934 configured to allow the bonding of an external flexible polymer layer (e.g., a cover or sheath) disposed along a portion of the outer surface of the main tube 1902 to a liner disposed along the inner surface of the main tube 1902 (e.g., similar to orifice 1546 of the sleeve shaft 1500). Simultaneously, the orifices 1934 may be configured to provide rigidity to the push rod shaft 1900.

[0333] FIG. 21EEmbodiments of the main tube 1902 shown in FIG. 19 include a first section 1930 and a second section 1932 spaced apart from one another, each of the first section 1930 and the second section 1932 including one or more apertures 1934 (e.g., through holes extending from an outer surface of the main tube 1902 and through the outer surface to an inner surface of the main tube 1902) extending through a thickness of the main tube 1902. The apertures 1934 can be spaced apart around a perimeter of the main tube 1902. In some embodiments, as shown in FIG. 19A, each aperture 1934 can extend through an entirety of the main tube 1902, resulting in two apertures 1934 arranged 180 degrees apart from one another around the perimeter of the main tube 1902. Further, in some embodiments, as shown in FIG. 19B, adjacent sets of apertures 1934 can be offset 90 degrees from one another (e.g., the first section 1930 can include 20 apertures). FIG. 21E FIG. 17E

[0334] The size and / or shape of each aperture 1934 and the number of apertures 1934 and spacing between the apertures 1934 in each of the first section 1930 and the second section 1932 can be selected to allow the main tube 1902, disposed between an outer flexible polymer layer and an inner liner, to bond (e.g., adhere) the outer flexible polymer layer to the inner liner and still provide rigidity to the putter shaft 1900. For example, in some embodiments, the apertures 1934 can be circular with a diameter in a range of 0.4 mm to 0.6 mm. In some embodiments, the apertures 1934 can be approximately 0.5 mm in diameter. In some embodiments, the apertures 1934 can have another shape, such as oblong, square, rectangular, star-shaped, triangular, or the like.

[0335] In some embodiments, along a length of the first section 1930 and the second section 1932, in an axial direction, the apertures can be spaced apart from one another at a first (center-to-center) distance 1952, and each set of apertures 1934 at the same axial location can be spaced apart from an adjacent set of apertures 1934 at a second distance 1954. In some embodiments, the first distance 1952 is approximately 2 mm, and the second distance 1550 is approximately 1.0 mm. In some embodiments, the first distance 1952 is in a range of 1.5 mm to 2.5 mm, and the second distance 1954 is in a range of 0.5 mm to 1.5 mm. In some embodiments, the second distance 1954 is half of the first distance 1952. In alternative embodiments, different numbers of apertures 1934 and / or relative spacing and arrangement between the apertures 1934 than shown in FIGS. 19A and 19B and described above are possible while still providing sufficient bonding between the inner liner and the outer polymer while providing rigidity to the putter shaft 1900. FIG. 21E

[0336] As shown in FIG. 19C, the main tube 1902 can include a first section 1930 and a second section 1932 spaced apart from one another, each of the first section 1930 and the second section 1932 including one or more apertures 1934 extending through a thickness of the main tube 1902. The apertures 1934 can be spaced apart around a perimeter of the main tube 1902. In some embodiments, as shown in FIG. 19C, each aperture 1934 can extend through an entirety of the main tube 1902, resulting in two apertures 1934 arranged 180 degrees apart from one another around the perimeter of the main tube 1902. Further, in some embodiments, as shown in FIG. 19D, adjacent sets of apertures 1934 can be offset 90 degrees from one another (e.g., the first section 1930 can include 20 apertures). FIG. 21E ​​​As shown, the second section 1932 is arranged at the proximal end 1916 of the main tube 1902 and includes fewer orifices 1934 than the first section 1930. However, in alternative embodiments, the second section 1932 can include more orifices 1934 than FIG. 21E shown. In some embodiments, the first section 1930 can include 20 orifices 1934 and the second section 1932 can include 8 orifices. In other embodiments, the first section 1930 can include more or less than 20 orifices 1934 and the second section 1932 can include more or less than 8 orifices 1934.

[0337] As FIG. 21B shown, the main tube 1902 can include a third section 1936 arranged between and extending between the first section 1930 and the second section 1932 that does not include any orifices 1934.

[0338] FIG. 21B An exemplary embodiment of the material and components of the shaft 1900 is shown. As FIG. 18 shown, the shaft 1900 can include an inner liner 1938 that covers the inner surface of the main tube 1902 and forms the inner surface of the proximal extension 1910. In some embodiments, the inner liner 1938 can extend along the entire length of the shaft 1900. The inner liner can be the same as or similar to the inner layer 1606 FIG. 21B shown). In some embodiments, the inner liner can include PTFE. Further, in some embodiments, the thickness of the inner liner 1938 can be in the range of 0.012 mm to 0.064 mm.

[0339] Additionally, in some embodiments, a portion of the shaft 1900 can include a polymeric layer (also referred to as an outer covering or sheath) 1940. The polymeric layer can be a flexible polymer, as further explained below. In some embodiments, the outer polymeric layer 1940 is arranged on and along a fourth section 1942 of the main tube 1902 that includes the distal section 1918 and the first section 1930 of the fourth section 1942, while the third section 1936 of the main tube 1902 does not include the outer polymeric layer 1940 FIG. 21E and FIG. 21C ). In some embodiments, the outer polymeric layer 1940 is also included on the second section 1932 of the main tube 1902 and forms an outer layer of the proximal extension 1910. For example, the proximal extension 1910 can include the inner liner 1938 and the outer polymeric layer 1940.

[0340] The outer polymer layer 1940 can be backflowed over the cutout 1920 and the aperture 1934. In certain embodiments, the outer polymer layer 1940 can include a polyether-amide block copolymer or a blend of two or more polyether-amide block copolymers. The polymer of the outer polymer layer 1940 can have a Shore D hardness measured according to ISO 868 of between about 60 to about 75, between about 65 to about 75, between about 70 to 75, or about 72. In some embodiments, the outer polymer layer 1940 can have a flexural modulus measured according to ISO 178:2010 of between about 350 MPa to about 550 MPa, between about 450 MPa to about 550 MPa, between about 500 MPa to about 550 MPa, between about 500 MPa to about 525 MPa, between about 510 MPa to about 520 MPa, about 500 MPa, about 505 MPa, about 510 MPa, about 515 MPa, about 520 MPa, or about 525 MPa. In certain embodiments, the outer polymer layer 1940 can be Arkema S.A. (France) and a blend of one or two or more of Pebax® grades E62, E72, and EX9200 (Evonik Industries AG, Germany). In some embodiments, the outer polymer layer 1940 can be 7233. In other embodiments, the outer polymer layer 1940 can be EX9200.

[0341] In some embodiments, the main tube 1902 can have a uniform inner diameter ranging from about 1.0 mm to about 1.34 mm from its distal end 1914 to its proximal end 1916, while the outer diameter can vary between about 1.8 to 2.0 mm (e.g., ± 0.2 mm) in the proximal and distal sections.

[0342] An exemplary embodiment of the distal tip 1942 of the pusher shaft 1900 is shown in FIG. 21A In some embodiments, the distal tip 1942 includes a more flexible polymer tip or a distal portion 1944 that includes a flexible polymer. In some embodiments, the polymer distal portion 1944 can include the same flexible material as and / or be continuous with the outer polymer layer 1940. Thus, the polymer distal portion 1944 of the distal tip 1942 can be backflowed over the distal end 1942 of the main tube 1902 and bonded to the inner liner 1938.

[0343] As FIG. 21B , FIG. 21D and FIGS. 22A-22CAs shown, the inner diameter 1948 of the outer casing 1904 is larger than the outer diameter 1950 of the main pipe 1902, thereby forming an annular cavity 1946 between the main pipe 1903 and the outer casing 1904 (in the radial direction). Thus, the proximal portion 1504 of the sleeve shaft 1500 can slide within the annular cavity (e.g., space) 1946, as shown below. FIG. 38 Further described. Additionally, in the hub assembly, flushing fluid supplied to the lumen on the exterior of the proximal extension 1910 can flow through the annular cavity 1946 and exit the distal end of the housing, as indicated by arrow 3202, to enter the lumen between the sleeve shaft 1500 and the outer shaft 2260 of the delivery system. FIGS. 35-38 The delivery shaft cavity 3216 shown below is referenced. FIG. 21F Further discussion is needed.

[0344] A side view of an exemplary embodiment of the housing 1904 of the push rod shaft 1900 is shown in FIG. 21F As shown in the diagram. The housing 1904 may include a distal segment 1960, a middle segment 1962, and a proximal segment 1964. The distal segment 1960 may be formed of an inner liner 1938 and an outer polymer layer 1966. In some embodiments, the outer polymer layer 1966 may include one of the flexible polymers described herein, such as... In some embodiments, the outer polymer layer 1966 may be of the same or a different grade than the outer polymer layer 1940 of the main shaft 1902. And / or has the same or different hardness as the outer polymer layer 1940. For example... FIG. 21F As shown, the distal end 1968 of the housing 1904 may have a rounded edge. The rounded edge of the distal end 1968 and the more flexible nature of the distal segment 1960 (due to its composition of an inner liner 1938 and an outer polymer layer 1966, rather than a more rigid tube) together provide a more non-invasive distal end to the housing 1904, thereby reducing or preventing wear on the inner surface of the outer shaft (e.g., outer shaft 2260) of the delivery system surrounding the housing 1904.

[0345] The intermediate segment 1962 of the outer casing 1904 may include an inner liner 1938, an outer polymer layer 1966, and a more rigid tube 1968 disposed between the inner liner 1938 and the outer polymer layer 1966 (in the radial direction). In some embodiments, the tube 1968 may include a metal, such as stainless steel. In some embodiments, the tube 1968 may be a thiocyanate tube. As described above, the tube 1968 may include a plurality of orifices 1970 extending through the entire thickness of the tube 1968, similar to the orifices 1934 of the main tube 1902. As described above, the size, number, and arrangement of the orifices 1970 can be selected to provide rigidity to the second segment 1962 while also allowing the outer polymer layer 1966 to flow through the orifices 1970 and form a strong bond with the inner liner 1938. In some embodiments, the diameter of the orifices 1970 may be in the range of 1.0 to 1.4 mm. In some embodiments, the diameter of the orifices 1970 may be approximately 1.2 mm.

[0346] The proximal section 1964 of the housing 1904 may include a tube 1968 without any orifices. Furthermore, as... FIGS. 35-37 As shown, the proximal segment 1964 does not include the outer polymer layer 1966 or the inner liner 1938. (As...) FIG. 21A As shown, the proximal segment 1964 of the housing 1904 may extend into and / or enter the hub assembly 2230 at a location angled away from and away from the cut portion 1508 of the sleeve shaft 1500, near the proximal extension 1910 of the push rod shaft 1900. The proximal end 1905 of the proximal segment 1964 of the housing 1904 may be configured as a receiving plug 1906, as further described below.

[0347] The plug 1906 can be configured to be disposed within the annular cavity 1946 at the proximal end 1905 of the housing 1904 (e.g. FIG. 21B , FIG. 21D , FIG. 23B and FIG. 21A As shown). In some embodiments, the plug 1906 may have a length 1907 extending in the direction of the central longitudinal axis 1901 (as shown). FIG. 21G (As shown). In some embodiments, the length 1907 is in the range of 3.0 mm to 9.0 mm, 4.0 mm to 8.0 mm, 5.0 mm to 7.0 mm, or 5.5 mm to 6.5 mm. In some embodiments, the length 1907 is approximately 6.0 mm.

[0348] The plug 1906 can be configured to "insert" or fill a portion of the annular cavity 1946 at the proximal end 1905, while leaving the remainder of that portion of the annular cavity open to receive the cut portion 1508 of the sleeve shaft 1500 therein. For example, as FIG. 21AAs shown in the end view, in some embodiments, the plug 1906 of the push rod shaft 1900 may include an annular portion 1972 and a crescent-shaped portion 1974 extending radially outward from one side of the annular portion 1972. The inner diameter 1976 of the annular portion 1972 can be selected such that the annular portion 1972 surrounds the outer surface of the main shaft 1902, and the outer diameter 1978 of the crescent-shaped portion 1974 can be selected such that the crescent-shaped portion 1974 fills the annular space 1946. For example, the inner diameter 1976 can be selected to be slightly larger than the outer diameter 1950 of the main shaft 1902, while the outer diameter 1978 can be selected to be slightly smaller than the inner diameter 1948 of the housing 1904 (e.g., ...). FIG. 20A (As shown). In some embodiments, the inner diameter 1976 is approximately 1.81 mm, while the outer diameter 1978 is approximately 3.42 mm. The arc length of the crescent-shaped portion 1974 can be in the range of 60 to 140 degrees, 80 to 120 degrees, 90 to 110 degrees, or 95 to 105 degrees.

[0349] In various embodiments, the housing 1904 and plug 1906 are welded to the main pipe 1902 to allow for the cutting portion 1508 of the sleeve shaft. FIG. 20B and FIG. 21D It slides between the main body 1902 and the outer casing 1904. For example, as... FIG. 23A As shown, the first weld 1980 can secure the annular portion 1972 of the plug 1906 to the spindle 1902, and the second weld 1982 can secure the crescent-shaped portion 1972 of the plug 1906 to the housing 1904. In some embodiments, each of the welds 1980 and 1982 can be a tack weld that does not extend along the entire mating surface between the plug 1906 and the spindle 1902 and the housing 1904.

[0350] In some embodiments, the proximal extension 1910 is in FIG. 23A and 23B As shown in the image. Pusher shaft and sleeve shaft assembly and 23B A proximal extension 1910 extending from the proximal end of the main tube 1902 and the housing 1904 is shown. As described above, the proximal extension 1910 provides flexibility to the push rod shaft 1900, allowing it to extend from the interior of the sleeve shaft (e.g., the cut portion 1508) to the exterior of the sleeve shaft, thereby allowing parallel actuation of the two shafts. In many embodiments, as described above, the proximal extension 1910 may be made of a flexible polymer. In some embodiments, the flexible polymer is a polyether-amide block copolymer or a blend of two or more polyether-amide block copolymers, such as... Grades 2533, 3533, 4033, 4533, 5533, 6333, 7033, and 7233 (Arkema SA, France) and Models E40, E47, E55, E62, E72 and EX9200 (Evonik Industrial AG, Germany).

[0351] FIG. 24B

[0352] As described above, the push rod shaft 1900 and the sleeve shaft 1500 can be used at least in a delivery system (e.g., FIGS. 22A-22C The delivery system 2220) is coaxial with each other within its outer shaft 2260 (e.g., the conduit portion). FIG. 33 An assembly diagram showing the arrangement of the push rod shaft 1900 and the sleeve shaft 1500 within the outer shaft 2260 of the delivery system. Additionally, FIG. 34 and FIG. 33 This is a perspective view showing an exemplary docking device 70 deployed from the outer shaft 2260 of the delivery system and covered by the distal (or sleeve) portion 1502 of the sleeve shaft 1500. FIG. 34 ) and the exemplary docking device 70 after the sleeve shaft 1500 has retracted into the outer shaft 2260. FIGS. 22A-22C ).

[0353] like FIG. 33 , FIG. 34 and FIGS. 22A-22C As shown, the sleeve shaft 1500 can be configured to cover (e.g., surround) the docking device 70, and the push rod shaft 1900 and sleeve shaft 1500 together can be configured to deploy the docking device 70 from the outer shaft 2260 of the delivery system upon reaching the target implantation site. As further described below, FIG. 33 , FIG. 34 and FIG. 22A The different stages of the implantation process are shown.

[0354] FIG. 22B and FIG. 22A This illustrates how the proximal section 1504 (including the cut portion 1508) of the sleeve shaft 1500 passes through the proximal portion 1912 of the push rod shaft 1900 within the annular cavity 1946 between the main tube 1902 and the housing 1904. Specifically, FIG. 33An example of the first configuration of the pushrod shaft 1900 and the sleeve shaft assembly prior to or during deployment of the docking device 70 is shown, where the sleeve shaft 1500 is disposed on the docking device 70 and the end face 1545 of the tube 1530 is positioned away from the plug 1906. During deployment of the docking device 70 from the outer shaft 2260 of the delivery system, the pushrod shaft 1900 and the sleeve shaft 1500 can move in the axial direction with the docking device 70. For example, actuation of the pushrod shaft 1900 to push the docking device 70 and move it out of the outer shaft 2260 can also cause the sleeve shaft 1500 to move with the pushrod shaft 1900 and the docking device 70. In this way, the docking device 70 can remain covered by the distal section 1502 of the sleeve shaft 1500 during the process of pushing the docking device 70 into the location of the target implant site via the pushrod shaft 1900, as well as FIG. 22A after the docking device 70 is implanted at the target implant site.

[0355] In some embodiments, as shown in FIG. 17B the outer shaft 2260 can have a first inner diameter 2104 at a distal end portion of the outer shaft 2260 and a second inner diameter 2106 at a more proximal end portion of the outer shaft 2260. The second inner diameter 2106 can be larger than the first inner diameter 2104 in order to accommodate the wider housing 1904 therein.

[0356] Additionally, as introduced above with reference to FIG. 33 and as shown in FIG. 33 , during delivery and implantation of the covered docking device 70 at the target implant site, the distal tip 1512 of the distal section 1502 of the sleeve shaft 1500 can extend distal to the distal end 1514 of the docking device 70 (e.g., beyond the distal end 1514 of the docking device 70), providing a more atraumatic tip for the distal section 1502 of the sleeve shaft 1500. In some embodiments, the distance between the distal tip 1512 of the sleeve shaft 1500 and the distal end 1514 of the docking device 70 can be in the range of about 3 mm to about 1 mm, about 2 mm to about 1.2 mm, or about 1.7 mm to about 1.4 mm during implantation at the target implant site and prior to retraction of the sleeve shaft 1500 from the docking device 70. As shown in FIG. 22B , in some embodiments, the distal end 1514 of the docking device 70 can be disposed proximate to or just distal to the marker band 1552 of the sleeve shaft 1500.

[0357] FIG. 22B A second configuration of the pushrod shaft 1900 and the sleeve shaft 1500 assembly is shown after deployment of the docking device 70 from the outer shaft 2260 at the target implant site and retraction of the sleeve shaft 1500 from the implanted docking device 70. As shown in FIG. 22BAs shown, after the docking device 70 is inserted into the target implantation site, the sleeve shaft 1500 can be pulled out from the docking device 70 and retracted into the outer shaft 2260 at the desired position. In some embodiments, such as FIG. 34 As shown, when end face 1545 comes into contact with plug 1906, it can prevent sleeve shaft 1500 from retracting further into the delivery system.

[0358] FIG. 34 The sleeve shaft 1500 is shown removed from the docking device, leaving the docking device 70 uncovered. FIG. 24A As shown, the distal end 1512 of the sleeve shaft 1500 can be arranged proximal to the distal end of the push rod shaft 1900 (e.g., retracted from the distal end of the push rod shaft 1900), the distal end of the push rod shaft 1900 still being connected to the end of the docking device 70 via suture 2236. As further explained below, after the docking device 70 is inserted into the target implantation site and the distal portion 1502 of the sleeve shaft 1500 is removed from the covering docking device, the suture locking assembly of the delivery system (e.g., ...) can be used to lock the device. FIGS. 27A-29D The suture locking assembly 2206 and / or shown FIG. 22C The suture locking element 2700 shown disconnects the docking device 70 from the delivery system by cutting the suture 2236.

[0359] Go to FIGS. 35-38 Some embodiments include a sealing mechanism 1908 located on the main pipe 1902 of the push rod shaft 1900 in some embodiments. In some embodiments, the sealing mechanism 1908 forms a seal between the main pipe 1902 of the push rod shaft 1900 and the sleeve shaft 1500 to prevent fluid from being flushed through the system to flow back or find a lower resistance path through another lumen (see below). FIG. 20A (Further description). Some embodiments will use a washer made of plastic, rubber, PTFE, PBAX, or another suitable material, which is placed on the main pipe 1902 of the push rod shaft 1900. In embodiments using a washer, the washer is joined in place by fusing it to the main pipe 1902, while some embodiments will use glue or other adhesives to adhere the washer. Additional embodiments will manufacture the main pipe 1902 to include a bump or protrusion on the main pipe 1902 extending toward the sleeve shaft 1500 as a sealing mechanism 1908, while some embodiments will form a bump or protrusion on the sleeve shaft 1500 extending toward the main pipe 1902 as a sealing mechanism. Some embodiments will include multiple sealing mechanisms 1908 to form a seal between the main pipe 1902 of the push rod shaft 1900 and the sleeve shaft 1500 in any combination of bumps and / or washers. In addition to one or more sealing mechanisms 1908, additional embodiments will further include a washer positioned proximal to the sleeve shaft 1500 (e.g., Processing systemgasket 1804).

[0360] FIG. 24B

[0361] As described above, the delivery system (e.g., FIG. 24B The delivery system 2220) can include a handle assembly 2200 configured to control the operation of the delivery system including the pushrod shaft and the sleeve shaft. The handle assembly can be configured in various ways with one or more of various components, handles, hubs, connectors, knobs, shafts, etc. An example embodiment of a complete handle assembly 2200 is shown in FIG. 24A FIG. 22A, as described above. As shown and introduced above, the handle assembly 2200 of some embodiments includes a hub assembly 2230, which in some embodiments can include a Y-connector (e.g., adapter) having a straight section (e.g., straight channel) 2202 and at least one branch (e.g., branch channel) 2204 (although in some embodiments it can include more than one branch). FIG. 24B In some embodiments, a suture lock assembly (e.g., suture lock) 2206 can be attached to the branch 2204, and a sleeve actuation handle 2208 (which can be similar to the sleeve handle 2234 of

[0362] In some embodiments, a suture lock assembly (e.g., suture lock) 2206 can be attached to the branch 2204, and a sleeve actuation handle 2208 (which can be similar to the sleeve handle 2234 of FIG. 24B The hub assembly 2230 can be adapted and configured to allow the proximal extension 1910 of the pushrod shaft 1900 (or another similar pushrod shaft) to extend to the suture lock assembly 2206 arranged at the end of the branch 2204, while the cutting portion 1508 of the sleeve shaft 1500 extends to the sleeve actuation handle 2208 arranged at the end of the straight section 2202. With this configuration, the medical professional can perform the deployment of the docking device (e.g., FIGS. 9A-12G the docking device 2232 and / or FIG. 22C and 22A- FIGS. 22A-22C the docking device 70) of

[0363] The sleeve shaft and push rod shaft assemblies can be configured to work together such that they can move simultaneously together (e.g., by moving the entire hub assembly 2230 forward and / or backward in the axial direction) when the docking device is deployed and positioned at the natural valve, but they can also move independently, so that the push rod shaft 1900 can hold the docking device in place when the sleeve shaft 1500 is retracted from the docking device (e.g., by holding the hub assembly 2230 in place relative to the outer shaft 2260 of the delivery system and / or other components of the delivery system and / or the docking device, while pulling the sleeve actuation handle 2208 proximally to retract the sleeve). As described above and ​ As shown, the sleeve shaft 1500 and the push rod shaft 1900 may be coaxial along some, all, or most of the delivery system to jointly facilitate the operation.

[0364] The handle assembly 2200 may include one or more flushing ports capable of flushing various lumens (e.g., annular spaces between components such as coaxial shafts) arranged between axially extending parts of the delivery system. For example, as... FIG. 38 As shown, it illustrates the distal portion of a delivery system (e.g., delivery system 2220) including a push rod shaft (e.g., push rod shaft 1900) and a sleeve shaft (e.g., sleeve shaft 1500) arranged within the outer shaft 2260 of the delivery system, and various lumens configured to receive flushing fluid during delivery and implantation procedures are formed between the docking device 70, push rod shaft 1900, sleeve shaft 1500, and outer shaft 2260. A first push rod shaft lumen 3210 may be formed within the push rod shaft (e.g., within the main tube 1902). The push rod shaft lumen 3210 may receive flushing fluid from a first fluid source that may be fluidly coupled to a portion of the handle assembly (e.g., branch 2204, as further described below). The flushing fluid flow 3204 through the push rod shaft lumen 3210 may travel along the length of the main tube 1902 of the push rod shaft 1900 to the distal end 1914 of the push rod shaft 1900. FIG. 38As shown, because the distal end 1914 of the pusher shaft 1900 can be spaced apart from the proximal end of the docking device 70, at least a portion of the flush fluid flow 3204 can flow as flush fluid flow 3208 into a first portion of the second sleeve shaft lumen 3212 disposed between the outer surface of the docking device 70 and the inner surface of the distal section 1502 of the sleeve shaft 1500. Further, in some embodiments, a portion of the flush fluid flow 3204 can also flow as flush fluid flow 3206 into a second portion of the sleeve shaft lumen 3214 disposed between the outer surface of the pusher shaft 1900 and the inner surface of the sleeve shaft 1500. In this way, the same first fluid source can provide flush fluid to each of the pusher shaft lumen 3210, the first portion of the sleeve shaft lumen 3212, and the second portion of the sleeve shaft lumen 3214 via the pusher shaft lumen 3210.

[0365] Also as FIG. 38 shown, a third delivery shaft lumen 3216 can be formed in an annular space between the inner surface of the outer shaft 2260 and the outer surface of the sleeve shaft 1500. The delivery shaft lumen 3216 can receive flush fluid from one or more second fluid sources, which can be fluidly coupled to a portion of the handle assembly (e.g., the branch 2204 and / or the handle 2222, as described further below), and can generate a flush fluid flow 3202 that flows through the delivery shaft lumen 3216 to the distal end of the outer shaft 2260.

[0366] Flushing the above lumens is important to prevent thrombus formation on and around the docking device and other concentric components of the delivery system during deployment of the docking device from the delivery system and implantation of the docking device at the target implant site. To flush these lumens, various embodiments will have one or more flush (irrigation) ports disposed on and / or coupled to the handle assembly 2200 of the delivery system. FIG. 24A , FIG. 24B , FIG. 28A , FIG. 35 and FIG. 36 different embodiments of possible flush port arrangements configured to provide flush fluid to the lumens described above with reference to FIG. 38 . Additionally, FIG. 37 shows flush fluid flowing through a portion of the delivery system disposed between the hub assembly 2230 (as shown in FIG. 24A , FIG. 35 and FIG. 36 ) and the distal end portion of the delivery system (as shown in FIG. 38 ).

[0367] In a first embodiment of the flush port arrangement, the handle assembly 2200 can include two flush ports arranged on a branch 2204 of the hub assembly 2230 (which can be referred to as a suture lock branch), with one flush port providing a flush fluid flow 3204 to the pusher shaft lumen 3210 and the other flush port providing a flush fluid flow 3202 to the delivery shaft lumen 3216. For example, the two flush ports on the branch 2204 can include a first flush port 2210 and a second flush port 2216, with the first flush port 2210 arranged on the branch 2204 proximal to the second flush port 2216. In some embodiments, the second flush port 2216 can be positioned on the branch 2204 more proximally or more distally than shown in FIG. 24A , FIG. 35 and FIG. 36 .

[0368] As shown in FIG. 24A , FIG. 35 and FIG. 36 , the first flush port 2210 has an internal flow lumen that is fluidly connected to the internal cavity 2250 in the branch 2204. An open proximal end 2252 of the proximal extension 1910 of the pusher shaft 1900 can be fluidly coupled to and / or arranged within the internal cavity 2250 (as shown in FIG. 24A , FIG. 35 and FIG. 36 ). As described above, the proximal extension 1910 extends through the branch 2204, into the straight section 2202 of the hub assembly 2230, and connects to the main tube 1902 of the pusher shaft FIG. 36 . Thus, the pusher shaft lumen 3210 is formed by and within the main tube 1902 and the proximal extension 1910. In this way, the flush fluid flow 3204 from the first flush port 2210 enters the pusher shaft lumen 3210 at the proximal end 2252 of the proximal extension 1910 and continues into and through the entire main tube 1902 of the pusher shaft to the distal end 1914 (as shown in FIG. 38 .

[0369] The second flush port 2216 has an internal flow lumen that is fluidly connected to an elongated space or cavity 2254 (which can be annular along at least a portion of the cavity) that encircles the exterior of the proximal extension 1910 within the branch 2204 and extends into the straight section 2202 in the space between the inner surface of the cut portion 1508 of the proximal section 1504 of the sleeve shaft 1500 and the proximal extension 1910. Thus, the flush fluid flow 3202 from the second flush port 2216 can enter the cavity 2254 and flow through the cavity 2254 around the proximal extension 1910 and into the annular cavity 1946 (FIG. 37 ). As explained above with reference to FIG. 21A and FIG. 22A , the flush fluid flow 3203 can flow through the annular cavity 1946 and exit the distal end of the housing 1904 to enter the delivery shaft 3216 lumen, as indicated by the arrows 3202 in FIG. 21A and FIG. 22A .

[0370] In some embodiments, as shown in FIG. 24B and FIG. 35 , the delivery shaft lumen 3216 can be provided with additional flush fluid from a third flush port 2218, in addition to fluid from the second flush port 2216, the third flush port 2218 fluidly coupled to the annular cavity 1946 downstream of (e.g., distal of) the plug 1906. In this way, in some embodiments, supplemental flush fluid 3218 can combine with the flush fluid flow 3202 and be supplied to the delivery shaft lumen 3216. In some embodiments, as shown in FIG. 24B and FIG. 35 , the third flush port 2218 can be disposed on a portion of the handle 2222. In alternative embodiments, the third flush port 2218 can be disposed at a more distal location on the handle than shown in FIG. 24B and FIG. 35 . In some embodiments, the third flush port 2218 can not be used during an implantation procedure, but instead can only be used to flush the delivery shaft lumen 3216 prior to insertion of the delivery system into the patient. In some embodiments, the delivery system can not include the third flush port 2218.

[0371] Various embodiments of the hub assembly 2230 of the first embodiment including the above-described flush port arrangement can include a grommet 2211 between the two flush ports within the branch 2204 to create separate and distinct fluid flow lumens on the branch 2204 fed by the two flush ports (e.g., the first flush port 2210 and the second flush port 2216 shown in FIG. 24A , FIG. 35 and FIG. 36 , or the first flush port 2210 and the third flush port 2218 shown in FIG. 28AThe illustrated second flush port 2216 and flush port 2806). For example, the grommet 2211 can be configured as a disc having a single (e.g., in some embodiments, centered) hole configured to tightly receive the proximal extension 1910 therein. The grommet 2211 can not include any additional holes, and can be further configured to provide a seal between the inner cavity 2250 and the cavity 2254. As a result, all flush fluid flow 3204 into the inner cavity 2250 from the first flush port 2210 (or alternatively, from the flush port 2806, as further described below) can enter the pusher shaft lumen 3210 without entering the cavity 2254 and flowing to the delivery shaft lumen 3216. Likewise, all flush fluid flow 3202 into the cavity 2254 from the second flush port 2216 can enter the annular cavity 1946 and the delivery shaft lumen 3216.

[0372] In a second embodiment of the flush port arrangement, the handle assembly 2200 can include two flush ports arranged on the branch 2204 of the hub assembly 2230 (which can be referred to as a suture lock branch), with one flush port providing flush fluid flow 3204 to the pusher shaft lumen 3210 and the other flush port providing flush fluid flow 3202 to the delivery shaft lumen 3216. However, in the second embodiment, the flush port providing flush fluid flow 3204 to the pusher shaft lumen 3210 can be arranged at the proximal end of the branch 2204, at one end of the suture lock assembly (e.g., the suture lock assembly 2206 of FIG. 24A and FIG. 24B the suture lock assembly 2700 of FIG. 27A-FIG. 29D ). For example, as illustrated in FIG. 28A , the flush fluid flow 3204 can be provided via a flush port 2806 arranged at the proximal end of the suture lock assembly 2700. In this way, the flush fluid flow 3204 can be provided to the pusher shaft lumen 3210 via a flush port (e.g., the flush port 2806) having a flow lumen arranged parallel to (rather than perpendicular to, as illustrated in FIG. 24A , FIG. 24B , FIG. 35 and FIG. 36 the pusher shaft lumen 3210.

[0373] Flush port arrangement embodiments with multiple flush ports (such as the first and second embodiments described above) can be supplied with flush fluid independently (e.g., using two separate fluid supply sources) or together with a common fluid supply source. For example, in some embodiments, each flush port (e.g., first flush port 2210 and second flush port 2216 or flush port 2806 and second flush port 2216) can be supplied with flush fluid from two separate infusion pumps (one fluidly coupled to each flush port) or another set of fluid sources. In alternative embodiments, a single infusion device (e.g., pump) 3220 can be connected to multiple flush ports, such as by connecting a single fluid line to a Y-connector 3222 of the multiple flush ports, as... FIG. 35 As shown. FIG. 35 As shown, fluid is supplied from the same source (e.g., infusion pump 3220) to the first flush port 2210 and the second flush port 2216. In some embodiments, the infusion pump 3220 may supply fluid to the flush port 2806 and the second flush port 2216.

[0374] It may be desirable to balance the flushing fluid flow between lumens, such that the flow rate of flushing fluid in each lumen is equal. However, in some embodiments, the flushing fluid flow through the push rod shaft lumen 3210 may have increased resistance relative to the delivery shaft lumen 3216. In one example, this increased resistance may be due to the covering (e.g., FIG. 12A-FIG. 12D The narrower flow cavity and / or friction between the cover 100 and the sleeve section of the sleeve shaft (e.g., sleeve 1502 in FIG. 17) is a contributing factor. As an example, additional flushing ports can be added to supplement the flow to the push rod shaft cavity 3210 to equalize the flow rates between the cavities. As another example, two separate infusion devices can be used to provide the desired flushing fluid flow rates to the push rod shaft cavity 3210 and the delivery shaft cavity 3216. As yet another example, when using a single infusion device to supply both flushing ports, the resistance in the delivery shaft cavity 3216 can be increased to equalize the relative resistance between the delivery shaft cavity 3216 and the push rod shaft cavity 3210. For example, in some embodiments, the flow rate of fluid received by the delivery shaft cavity 3216 and the push rod shaft cavity 3210 from the single infusion device 3220 can be changed by altering the inner diameter of one or both of the flush port cavities (e.g., reducing the diameter of the inner cavity of the second flush port 2216 relative to the first flush port 2210), the diameter of the branch portion of the Y-connector 3222, or the diameter of another component used to change the relative flow rate to the cavity 2254 (feed delivery shaft cavity 3216) and the push rod shaft cavity 3210.

[0375] In this manner, it can be desirable to balance the fluid flow resistance between and / or to the pusher shaft lumen 3210 and the delivery shaft lumen 3216 such that both of these lumens receive equal flushing fluid flow from a single source (e.g., a single infusion device 3220). Various embodiments can include varying the resistance of one or more components in one of the two flow paths (e.g., the pusher shaft lumen flow path or the delivery shaft lumen flow path) and / or providing one or more devices that meter the uniform flow rate of flushing fluid into each of the pusher shaft lumen 3210 and the delivery shaft lumen 3216. Thus, the flushing fluid flow into these two lumens can be controlled by any means known in the art to ensure that the flow rates in the lumens are equal based on their relative resistance. Furthermore, during an implantation procedure, there is a difference in the flow resistance within and between each of the pusher shaft lumen 3210 and the delivery shaft lumen. Thus, it can be desirable to deliver flushing fluid to these lumens separately (e.g., via separately controlled flow sources) or via a single infusion device 3220 with a mechanism for balancing the resistance between the lumens (and providing a target flow rate).

[0376] Some embodiments can include a mechanism (such as a sensor, an alarm, or the like) for detecting when the flow rate of flushing fluid falls below a preset threshold flow rate within one or more lumens (e.g., the pusher shaft lumen and the delivery shaft lumen) that receive the flushing fluid. For example, the infusion device can have an alarm to alert a medical professional or user of a flow obstruction, which can be caused by a thrombus occluding the system. A thrombus can cause a stroke if it is dislodged during installation of the docking device. Additionally, a thrombus can increase the force experienced during removal of the distal portion of the sheath shaft 1502 from the docking device due to increased friction between the sheath and the docking device. As one example, the use of two infusion devices allows certain embodiments to identify when a thrombus is formed in one or more lumens, including when a gasket or other sealing mechanism (e.g., the gasket 1804 shown in FIG. 20 and the sealing mechanism 1908 shown in FIG. 19B) is used to prevent cross-lumen flow. Further embodiments utilize a single infusion device connected to multiple flushing ports and use a flow sensor connected to the flow line (and / or an alarm) to notify a medical professional of a change in flow rate, which can indicate an obstruction, such as a thrombus. FIG. 22C

[0377] ​In a third embodiment of the flush port arrangement, the handle assembly 2200 can include a single flush port arranged on the branch 2204 of the hub assembly 2230 that is configured to provide both flush fluid flows 3204 to the pusher shaft lumen 3210 and flush fluid flow 3202 to the delivery shaft lumen 3216. For example, certain configurations are able to flush all of the lumens described above with only one flush line, such as the first flush port 2210 (or alternatively, FIG. 28A the flush port 2806 shown in FIG. 28) in the branch 2204. In such embodiments, the single flush port can provide fluid to two separate lumens (the pusher shaft lumen 3210 and the delivery shaft lumen 3216) by incorporating the flush plate 2300 (shown in FIG. 29) into the branch 2204 perpendicular to the flow path through the pusher shaft lumen 3210 and the cavity 2254. For example, in some embodiments, the flush plate 2300 can be arranged in the branch 2204 as shown in FIG. 25 FIG. 30 (e.g., in place of the gasket 2211 and without the second flush port 2216), or further arranged downstream of the gasket as shown in FIG. 36

[0378] FIG. 25 A flush plate 2300 that can be used in various embodiments is shown. As shown in FIG. 25 FIG. 29, the flush plate 2300 can have openings or apertures 2301a, 2301b, and 2301c cut into it to equalize the resistance between the various lumens. The openings / apertures 2301a, 2301b, and 2301c cut into the flush plate 2300 are designed to equalize the flow of flush fluid from the apertures into each lumen, ensuring that sufficient flush fluid flow is provided to both the pusher shaft lumen 3210 and the delivery shaft lumen 3216.

[0379] Returning to FIG. 24A In some embodiments, a hemostatic seal, such as the hemostatic seal 2400 shown in FIG. 26A and FIG. 26B is used to seal around the cutting portion 1508 of the proximal section 1504 of the sleeve shaft 1500 near the sleeve actuation handle 2208. FIG. 26A A hemostatic seal 2400 according to various embodiments is shown. As shown in FIG. 26A FIG. 31, the hemostatic seal 2400 can have an opening 2406 shaped as a cross-section of the cutting section 1508 of the sleeve shaft 1500, such as a U-shape or an incomplete (e.g., partial) torus, configured to receive the cutting portion 1508 therein and seal on all sides of the sleeve shaft 1500. FIG. 26B A hemostatic seal 2400 in operation and arranged within the straight section 2202 of the hub assembly 2230 according to many embodiments is shown. In some embodiments, as shown in​FIG. 26B As shown, two rigid washers 2402 and 2404 can support each end of the hemostatic seal 2400. The rigid washers 2402, 2404 can have the same profile as the hemostatic seal 2400 to maintain the integrity of the hemostatic seal 2400. In several embodiments, the rigid washers 2402, 2404 apply pressure inward onto the hemostatic seal 2400 to ensure a seal between the hemostatic seal 2400 and the cutting portion 1508 of the sleeve shaft 1500. Returning to FIG. 24A The hemostatic seal 2400 can be located near the sleeve actuation handle 2208, such as at the point 2212 in many embodiments. By placing the hemostatic seal 2400 near the sleeve actuation handle 2208, some embodiments incorporate a locking cap assembly 2214 into the handle assembly 2200 to allow for adjustment of the inward pressure applied on the hemostatic seal in order to lock and / or secure the sleeve shaft 1500 (e.g., from axial translation relative to the hub assembly 2230 and the rest of the pushrod shaft 1900) by applying additional pressure on the sleeve shaft.

[0380] As FIG. 24A and FIG. 24B shown and introduced above, the delivery system can include a suture locking assembly 2206 located on the branch 2204 of the hub assembly 2230 of the handle assembly 2200. FIG. 27A-FIG. 29D An embodiment of a ratchet suture lock 2700 of the suture locking assembly 2206 of the delivery system 2220 that can be used as FIG. 24A and FIG. 24B shown and introduced above, the delivery system can include a suture locking assembly 2206 located on the branch 2204 of the hub assembly 2230 of the handle assembly 2200. FIG. 27A An embodiment of a ratchet suture lock 2700 of the suture locking assembly 2206 of the delivery system 2220 that can be used as

[0381] As FIG. 27A shown, additional embodiments of the hub assembly including the suture lock 2700 include an irrigation line 2216 to allow for irrigation of one or more lumens within the delivery device (e.g., the delivery shaft lumen 3216) to maintain hemostasis within the delivery device and / or to sterilize the delivery device (as described above with reference to FIG. 35-FIG. 38 FIG. 24A and FIG. 24B ​Similar to the system shown, a medical professional deploys the docking device by manipulating the position of the handle assembly 2200 and retracts the sleeve by pulling the sleeve actuation handle 2208 backward, adding only one additional step. The sleeve assembly and push rod assembly can be configured to work together such that when the docking device is deployed and positioned at the natural valve (e.g., by moving the entire hub assembly 2230 and / or the Y-connector forward and / or backward), the sleeve assembly and push rod assembly can move simultaneously together. However, the sleeve assembly and push rod assembly can also move independently so that when the sleeve is retracted from the docking device (e.g., by holding the hub assembly and / or the Y-connector in place relative to the main axis of the delivery system and / or other components of the delivery system and / or the docking device while pulling the sleeve actuation handle 2208 proximally to retract the sleeve), the push rod / push rod shaft can hold the docking device in place. As described above, the sleeve shaft and push rod shaft can be coaxial with some, all, or most of the delivery system to facilitate joint operation.

[0382] like FIG. 27A-FIG. 28A and FIG. 29C As shown, the suture locking member 2700 in many embodiments includes a rotator 2702 (also referred to as a rotatable handle) to increase and decrease the suture 2812 (in FIG. 28B-FIG. 28D (as shown in the diagram) tension, suture 2812 extends from suture locking member 2700, passes through branch 2204 and through delivery system to connect to docking device (e.g., similar to FIG. 24B and FIG. 34 The release suture 2236 is shown.

[0383] In many embodiments, the suture 2812 is wound around the spool 2930 of the suture locking member 2700. FIG. 27C , FIG. 29C and FIG. 29D A rotator (e.g., a handle) 2702 may be coupled to a spool 2930 so that rotating the rotator 2702 in a given direction will adjust (e.g., increase or decrease) the tension on the suture 2812 passing through the delivery device (e.g., delivery system 2220). Providing tension or slack to the suture 2812 by rotating the rotator 2702 (thereby rotating the spool 2930) can respectively bring the docking device closer to or further away from the delivery system.

[0384] like FIG. 27BAs shown, in some embodiments, the rotator 2702 may include one or more gripping portions or grips that make it easier (e.g., via a user's hand) to grip the rotator 2702 without slipping. For example, the rotator 2702 may include a first gripping portion 2703 arranged around the periphery of the rotator and configured to be gripped by a user during rotation of the rotator 2702. In some embodiments, the first gripping portion 2703 may include multiple ridges to increase the traction of the grip and make it easier to grip. The rotator 2702 may further include a second gripping portion 2701 arranged on the top surface of the rotator 2702. Furthermore, in some embodiments, the first gripping portion 2703 and / or the second gripping portion 2701 may include a material with lower stiffness (e.g., reduced stiffness).

[0385] In some embodiments, the suture locking member 2700 may further include a directional control mechanism, which may include a directional selector 2704 (e.g., as shown in the figure). FIG. 27A-FIG. 27C (In the form of a switch shown), the orientation selector 2704 allows a physician or other user to select whether to increase or decrease the slack in the suture 2812 passing through the delivery device. For example, the orientation selector 2704 in various embodiments would allow the physician or other user to select a direction (e.g., increase or decrease tension), which would allow the rotator 2702 to rotate only in one direction to prevent the physician or other user from making a wrong orientation.

[0386] For example, such as FIG. 27C and FIG. 29A As shown, the spool 2930 may include a gear 2902 that can engage with a pawl 2904, which allows the gear 2902 to rotate, thereby causing the rotator 2702 and the spool 2930 to rotate in only one direction. The direction of rotation of the rotator 2702 depends on the orientation of the pawl 2904, which is controlled by the orientation selector 2704. In some embodiments, such as FIG. 27A and FIG. 27C As shown, the top housing 2710 may include a first icon 2706 indicating the relaxed position of the orientation selector 2704 and a second icon 2708 indicating the tensioned position of the orientation selector 2704.

[0387] like FIG. 29A As shown, in some embodiments, the orientation control mechanism may be a ratchet mechanism that restricts the orientation movement of the physician or other user from the rotator 2702. FIG. 27B , FIG. 27C and FIG. 29AAs shown, gear 2902 is attached to rotator 2702, while pawl 2904 is attached to orientation selector 2704. Pawl 2904 can be designed to mesh with teeth 2910 of gear 2902 such that gear 2902 can only rotate in one direction at a time. When pawl 2904 is actuated (e.g., pivoted) to a certain position (e.g., tensioned or relaxed), spring plunger 2906 engages the back of pawl 2904, thereby holding pawl 2904 in the selected orientation / position (as shown, for example, in FIG. 27C and FIG. 29A As shown, when meshing in one direction, one or more teeth 2908 of pawl 2904 interact with teeth 2910 on gear 2902. Additionally, detents 2912 can be formed to prevent bi-directional movement of pawl 2904, thereby allowing gear 2902 to only move in one direction. Detents 2912 can be configured in a variety of ways, including making them part of top housing 2710, or adding extra material (e.g., pins, spacers, etc.) inside housing 2710 to prevent bi-directional movement of pawl 2904.

[0388] FIG. 29E To illustrate FIG. 29A an example operation of the orientation control mechanism shown in FIGS. 27A-27B, a chart 2950 is shown. As shown in FIG. 29E when orientation selector 2704 is in the relaxed position (e.g., as shown in FIG. 27A when rotator 2702 is rotated counterclockwise, pawl 2904 is pushed clockwise by gear 2902 to allow rotation (as shown in block 2952 of chart 2950). When teeth 2910 of gear 2902 pass teeth 2908 of pawl 2904, spring plunger 2906 pushes pawl 2904 counterclockwise to mesh with the next tooth of gear 2902. When rotator 2702 is rotated clockwise (e.g., with orientation selector 2704 in the relaxed position), gear 2902 rotates pawl 2904 counterclockwise until it hits the hard detent 2912 on top housing 2710 (e.g., as shown in FIG. 29A and block 2954 of chart 2950). As described above, this hard detent 2912 stops spool 2930 from rotating further and stops the load from rotating instead of teeth 2908 of pawl 2904. When orientation selector 2704 is moved to the tensioned position, due to the same mechanism as described above for the relaxed position, spool 2930 can only rotate clockwise (as shown in blocks 2956 and 2958 of chart 2950). In some embodiments, hard detent 2912 is designed to mesh while spring plunger 2906 is still engaged with pawl 2904, which can prevent a feeling of slack in orientation selector 2704 when at rest.

[0389] FIG. 29B-FIG. 29DAdditional embodiments of directional control mechanisms for suture lock including a clutch system, such as suture lock 2700, are shown. The clutch system can be configured to limit the amount of tension that can be applied to a suture (e.g., suture 2812) and avoid potential damage or degradation to the delivery system and / or docking device.

[0390] Turning to FIG. 29B In accordance with some embodiments, a directional control mechanism with a clutch is shown that disengages the spool 2930 from the rotator 2702 and uses a friction pad to transfer torque from the rotator 2702 to the spool 2930. In particular, FIG. 29B A side cutaway view of a portion of a suture lock (e.g., suture lock 2700) is shown in which a rotator 2702 is connected to a center screw 2916 and a friction control nut 2918 is connected near the distal end of the center screw 2916. The center screw 2916 extends through the center of the spool 2930 and is coupled to the spool 2930. Friction pads 2920 are disposed around the center screw 2916 above and below a central portion of the spool 2930 such that rotating the rotator 2702 too far in one direction will cause the friction on the center screw 2916 to increase such that further rotation is prevented. For example, when the tension in the suture reaches a predetermined threshold, the increased friction from the friction pads 2920 can prevent the spool 2930 from being rotated when the rotator 2702 is turned.

[0391] In alternative embodiments, as FIG. 29C-FIG. 29DAs shown, this figure illustrates a pin-based clutch system used in some embodiments. In such an embodiment, a spring plunger 2922 transmits torque from a rotator 2702 to a spool 2928 (which may be similar to spool 2930). The spring plunger 2922 rests in (e.g., engages with) a pawl 2924 in a gear 2926 (gear 2926 may be similar to and used similarly to gear 2902) to allow the drive of the spool 2928 to increase or decrease the tension in the suture. The pawl 2924 may be arranged in an outward-facing surface of the gear 2926, in which lines orthogonal to the outward-facing surface are arranged perpendicular to the gear's facing surface, which includes the gear teeth. Under a designed suture tension (e.g., tension above a predetermined threshold), the spring plunger 2922 may slide out of one of the pawls and move to an adjacent (e.g., the next) pawl 2924. Thus, when the rotator 2702 rotates beyond a certain point, the spring plunger 2922 retracts, preventing further rotation of the rotator 2702 and reducing deterioration of the docking device and / or delivery system due to excessive tension applied to the suture. Deterioration of the docking device and / or delivery system is only at risk when tension is applied to the suture. Therefore, the pawl 2924 can be designed to slide only in the tensioned configuration and not in the relaxed configuration.

[0392] Return to FIG. 27A-FIG. 27C and FIG. 28A-FIG. 28B In some embodiments, the suture locking member may include a connector or connection portion to attach the suture locking member 2700 to the handle assembly (e.g., FIG. 27A The handle assembly 2200). For example, the suture locking member 2700 may include a release lever 2820 that extends into and is coupled to the bottom housing 2712 of the suture locking member 2702. FIG. 27B-FIG. 28C In some embodiments, the release lever 2820 is attached to the bottom housing 2712 (e.g., via adhesive, welding, or other non-removable fixing method). FIG. 27B and FIG. 28A-FIG. 28C As shown, the release knob 2802 may be arranged around a portion of the release lever 2820 adjacent to the connection portion 2822 of the bottom housing 2712. The release knob 2802 may be configured to connect the suture locking member 2700 to the adapter 2270 of the delivery system. As described above, in some embodiments, such as FIG. 27A As shown, adapter 2270 may include a branch 2204 and a straight portion 2202. For example, a release knob 2802 may be screwed onto end 2272 of adapter 2270 to secure the suture locking member 2700 to adapter 2270. In some embodiments, the shape, size, and / or configuration of adapter 2270 may differ from... FIG. 27AThe illustrated embodiment, and can vary based on the delivery system, where the suture lock 2700 is configured to attach to (and be used with) the delivery system.

[0393] For example, in some embodiments, when the teeth of the release knob 2802 engage both the end 2272 of the adapter 2270 (or another adapter of the delivery system) and the release lever 2820, the suture lock 2700 is coupled to the delivery system and the suture cutting section 2804 is covered by the adapter 2270 (as shown in FIG. 27A 、 FIG. 28B and FIG. 28C ). In some embodiments, once the docking device (or other implant) is positioned in the desired location for release from the delivery system, the release knob 2802 can be unscrewed toward the bottom housing 2712, and the suture lock 2700 can be pulled proximally away from the adapter (e.g., delivery system adapter) 2270 to expose the suture cutting section 2804. In alternative embodiments, rotation of the release knob 2802 toward the bottom housing 2712 can expose the suture cutting section 2804 without the need to pull the entire suture lock 2700 away from the adapter 2270.

[0394] The suture cutting section 2804 allows the user or practitioner to cut the suture 2812 through the length of the delivery system (e.g., as shown by the suture 2236 in FIG. 24B and FIG. 34 to allow the docking device to be disconnected from the delivery system when installed in the heart or heart analog.

[0395] In some embodiments, once the suture 2812 is wrapped around the docking device or implant (e.g., as shown in FIG. 24B and FIG. 34 ) and is extended through the delivery system, through the release lever 2820 (including across the suture cutting section 2804, as shown in FIG. 28B ), and into the bottom housing 2712, the two suture ends of the suture 2812 can be threaded through two apertures 2932 disposed in the bottom end of the spool 2930 (or 2928 of FIG. 29D ), and then tied together to complete the loop. As shown in FIG. 29D , the spool 2928 (or 2930) can include a gap 2934 in the flange of the bottom of the spool 2928, which can prevent the suture 2812 from being crushed during assembly of the top housing 2710 and the bottom housing 2712.

[0396] In some embodiments, as shown in FIG. 27A , the rotator 2702 can include an indicator 2714 to track the number of turns applied and to position the spool gap 2934.

[0397] In many embodiments, as shown in FIG. 28C and FIG. 28D , the suture 2812 extends longitudinally through the release lever 2820 of the suture lock 2700, and the two strands of the suture are separated to span the divider 2814 disposed in the suture cutting section 2804. Various embodiments use the divider 2814 to separate the strands of the suture 2812 so that the user or practitioner can cut only one strand to release the docking device from the delivery device. For example, as shown in FIG. 28D the exposed portion of the suture 2812 can then be cut by a cutting mechanism, such as the cutting mechanism of FIG. 30A-FIG. 30C . Once the suture is cut, it can be removed from the delivery system, and the suture lock 2700 is reattached to the adapter 2270 of the delivery system by twisting the release knob 2802 onto the adapter 2270.

[0398] Additional embodiments maintain a seal within the suture lock 2700 to prevent leakage of blood, saline, or other fluids through the system by using multiple annular sealing elements (e.g., O-rings) 2816a-c. For example, as shown in FIG. 27C , FIG. 28C , FIG. 29B and FIG. 29C , the suture lock 2700 can include a first distal release lever O-ring 2816a( FIG. 27C and FIG. 28C ), a second proximal release lever O-ring 2816b( FIG. 27C and FIG. 28C ), and a spool O-ring 2816c( FIG. 27C , FIG. 29B and FIG. 29C). These O-rings 2816a-c can be configured to seal the suture path when the suture lock 2700 is assembled, allowing hemostasis when connected to a properly sealed delivery system. The spool O-ring 2816c can prevent leakage through the end of the suture path. The proximal release lever O-ring 2816b can prevent leakage between the release lever 2820 and the bottom housing 2712. In some embodiments, this allows the adhesive or other bonding agent that bonds the release lever 2820 to the bottom housing 2712 to only act as a bonding agent and not require a sealing function. The distal release lever O-ring 2816a can prevent leakage between the release lever 2820 and the delivery system adapter 2270 when the release knob 2802 is engaged. The release knob 2802 can be designed such that when there is any thread engagement with the adapter 2270, the distal release lever O-ring 2816a seals the suture lock mechanism (e.g., there can be no variable seal depending on how tight the release knob is). In some embodiments, there can be a hole in the bottom housing 2712 to act as a leak path in the event the seal deteriorates.

[0399] As introduced above with reference to FIG. 38 , additional embodiments of the suture lock 2700 include a flush port 2806 to allow flushing of one or more lumens within the delivery device to reduce thrombus formation between components of the delivery system, maintain hemostasis within the delivery device, and / or sterilize the delivery device. The flush port 2806 allows certain embodiments of the delivery device to independently flush lumens if a single flush line is occluded and / or hemostasis is not maintained within the delivery device. In certain embodiments, the flush port 2806 is an open port to allow constant flow through the delivery device, while certain embodiments have a self-sealing flush port 2806 such that the practitioner can introduce fluid into the delivery device as needed without constant flow. As shown in FIG. 28A , the flush port 2806 allows additional flush lines to be connected similar to multiple flush ports, such as FIG. 24B , and discussed above.

[0400] Turning to FIG. 28B and FIG. 28D , some embodiments of the suture lock 2700 have a segment that is keyed to prevent rotation of the suture lock 2700 about the handle assembly, preventing twisting of the suture and / or increasing practitioner accessibility. Keying of certain suture lock 2700 components can be achieved in various ways, including by creating a specific non-circular shape in the component, using a pin, groove, or any other method to maintain a non-rotational fit between the suture lock 2700 and the outer housing or handle assembly. For example, in some embodiments, as shown in FIG. 28BAs shown, either end of the release lever can be shaped to form a keyed connection 2808a and 2808b between the release lever 2820 and the bottom housing 2712 and between the release lever 2820 and the adapter 2270, respectively. For example, the proximal end 2824 of the release lever 2820 can be shaped to form the first keyed connection 2808a, and the distal end 2826 of the release lever 2820 can be shaped to form the second keyed connection 2808b.

[0401] In some embodiments, as FIG. 28D shown, the release lever 2820 can include one or more support ribs 2828 disposed on a central portion of the release lever, the central portion disposed between the distal end 2826 and the proximal end 2824 of the release lever 2820. For example, in some embodiments, the support ribs 2828 can include a plurality of axially extending ribs 2828 disposed around the perimeter of the release lever 2820 on either side of a central ring element 2830 extending around the perimeter of the release lever 2820.

[0402] FIG. 30A-FIG. 30C Cutting and suture removal systems used in various embodiments are shown. Such embodiments allow a user to cut and remove sutures, such as the suture 2812 shown in FIG. 28B-FIG. 28E without disrupting the hemostasis of the system, or relying on a scalpel or other cutting method to cut the suture. In particular, FIG. 30A a resting position is shown in which the cutting actuator 3002 is attached to the blade 3004, and the suture removal actuator 3006 is attached to the loop 3008 or hook, which is attached to the suture 2812. FIG. 30B cutting the suture 2812 by pressing down on the cutting actuator 3002 to cut the suture 2812, thereby severing the suture 2812. FIG. 30C removing the suture by removing the suture removal actuator 3006, which pulls the suture 2812 within the delivery device using the loop 2008.

[0403] Packaging for delivery system

[0404] As noted above, many embodiments utilize a coating, a lubricious coating, and / or a hydrophilic coating, such as a hydrogel, on the lubricious sleeve that covers the docking device. In some embodiments, the docking device itself can have a coating. After manufacture, the docking device and delivery system are shipped for use. During shipping or storage, the environment can change over time, such as with different weather patterns and / or geographic locations. These environmental changes can include changes in humidity. However, many hydrophilic coatings can absorb moisture from the environment. During shipping or storage of the delivery device, the hydrophilic coating can undergo one or more dry-wet cycles. Due to the dry-wet cycles, the hydrophilic coating on adjacent coils can stick together. Other coatings can also be prone to sticking together on adjacent coils. When the docking device is prepared or loaded into a delivery system for use, the coils sticking together can be problematic. As such, certain embodiments of the present invention are directed to packaging for delivery systems and docking devices as discussed herein.

[0405] Turning to FIG. 31A and FIG. 31B , a coil holder 3100 according to various embodiments is shown. As shown in FIG. 31A , a series of fins 3102 protrude from a central post 3104. In many embodiments, the fins 3102 separate individual turns or coils of a docking device or a sleeved docking device. By separating the individual coils or turns from one another, the coils will not be able to stick together even if they undergo dry-wet cycles during storage or shipping or in other situations. Adjacent fins 3102 in various embodiments are separated by a sufficient distance to allow a single turn of a sleeved docking device to be placed between them. Additionally, the coil holder 3100 of many embodiments includes a central opening 3106 formed in the central post 3104. In several embodiments, the central opening 3106 can be used to attach the coil holder 3100 to an outer package, which can have complementary protrusions on which the coil holder 3100 can be stacked using the central opening 3106. In some embodiments, the coil holder 3100 includes a central opening having an irregular shape, such as a winged circle, as shown in FIG. 31B , or another feature that will prevent the coil holder 3100 from rotating in an outer package. Additionally, the coil holder 3100 can be made of any material suitable for maintaining the separation of the individual coils and preventing sticking or coalescence of the coils, including plastics and polymers, such as acetal homopolymers.

[0406] The coil holder 3100, when installed in an outer package, can be placed in a low point or receptacle formed in the outer package. In some embodiments, the packaging of the coil holder 3100, as well as the position and alignment, are configured to allow for the preparation and loading of a docking device with a sleeve (e.g., retracting the sleeve and docking device into an outer catheter or outer sheath of a delivery system) without the need to remove the delivery device from the outer package or to allow for the preparation and loading of a docking device with a sleeve while the delivery device is in its packaged position.

[0407] Method

[0408] The present disclosure provides methods for delivering an implant to a native valve of a heart. The methods can be used to deliver any of the implants described herein, including those having non-limiting FIG. 7A to FIG. 16 The docking device shown in FIG. 1 1 and further described elsewhere herein. The method can include positioning a selected docking device at a native valve of a heart such that at least a portion of the leading turn of the docking device is located in a ventricle of the heart and around one or more valve leaflets of the native valve. In some embodiments, the implantation of the docking device can be used to reshape one or more tissues in the heart to repair the function of the native valve. In certain embodiments, the method can include delivering the docking device to a native mitral valve to repair the left ventricle and associated heart function. In further embodiments, the method can reduce the annulus diameter and apply tension on the chordae. In still further embodiments, the method can further include performing an edge-to-edge repair of native leaflets of the native valve, such as by attaching a clip to attach a free edge of an anterior mitral valve leaflet to a free edge of a posterior mitral valve leaflet.

[0409] In some embodiments, the method can include delivering an implantable prosthetic heart valve within the docking device after positioning the docking device at the native valve of the heart in a desired position. The method can be used to deliver any of the implantable prosthetic heart valves described herein, including those having non-limiting FIG. 3AThe valves shown in Figure 6 and further described elsewhere herein. In some embodiments, a suitable implantable artificial heart valve that can be used in this method may have an annular frame having an inlet and an outlet end that are radially collapsible and expandable between a radially collapsed configuration and a radially expanded configuration, the frame defining an axial direction extending from the inlet end to the outlet end; leaflet structures positioned within and fixed thereto within the frame; and a flange attached to the inlet end of the annular frame and designed to extend outward therefrom. In some embodiments, the method may further include positioning the implantable artificial heart valve in the radially collapsed configuration within a docking device and expanding the implantable artificial heart valve from the radially collapsed configuration to the radially expanded configuration, such that the frame of the implantable artificial heart valve applies radially outward pressure to at least a portion of the central region of the docking device.

[0410] In some respects, this disclosure further provides for the use of delivery systems described elsewhere herein, including those having their non-limiting Figure 17- FIG. 29E and FIG. 33-FIG. 38 The methods for delivering docking devices using delivery systems of various aspects are illustrated. In some embodiments, a delivery system suitable for use in this method may include: a delivery conduit; a docking device having an end portion at the end of a stabilizing turn positioned relative to a central region; a push rod shaft disposed in the delivery conduit and coupled to the end portion of the docking device; and a sleeve shaft coaxially positioned with and disposed between the delivery conduit and the push rod shaft. In some embodiments, the delivery system may be configured such that the push rod shaft and the sleeve shaft operate in parallel. In some embodiments, the positioning step of the method may include pushing the docking device out of the conduit using the push rod shaft. In some embodiments, the positioning step of the method may include holding the docking device in place using the push rod as the sleeve and / or conduit retracts from the docking device.

[0411] FIG. 39 A flowchart of a method 3300 for delivering a docking device to a natural valve of the heart and implanting the docking device and an associated artificial heart valve at the natural valve is shown. Method 3300 begins at 3302 and may include advancing a distal portion of a delivery system to the natural valve of a patient's heart, the delivery system being configured to deliver and implant the docking device, which is disposed within the distal portion and covered by a distal segment of the sleeve shaft of the delivery system. The delivery system may be one of the delivery systems described herein, including those referenced above. FIG. 17A-FIG. 29EThe delivery system components described. The docking device can include a coil extending along a central axis and including a central region having a plurality of turns, a leading turn extending from a first end of the central region, and a stabilizing turn extending from an opposite second end of the central region, in which a covering extends around and along a top turn of the central region, the top turn being disposed at the second end of the central region. For example, in some embodiments, the docking device can be as described herein with reference to FIG. 9A-FIG. 12E One of the docking devices described. Further, in some embodiments, the covering that extends around and along a top turn of the central region can be as described herein with reference to FIG. 12E The covering 100 shown. In some embodiments, the native valve can be a mitral valve of a heart.

[0412] At 3304, the method 3300 can include deploying the docking device from a distal end of the delivery system, the docking device being covered by the distal section of the sleeve shaft of the delivery system. As described herein with reference to FIG. 17A-FIG. 29E and FIG. 33-FIG. 37 Deploying the docking device can include pushing the covered docking device out of the outer shaft of the delivery system with the pushrod shaft of the delivery system. For example, pushing the docking device out of the outer shaft with the pushrod shaft can include actuating the pushrod shaft to extend out of the outer shaft of the delivery system distally (in an axial direction) in response to a user moving the hub assembly and / or handle assembly in a distal direction. As a result, both the pushrod shaft and the sleeve shaft can be moved axially out of the outer shaft together in the distal direction.

[0413] At 3304, the method can further include positioning the covered docking device at a native valve (e.g., the mitral valve 10 shown in FIG. 1 and FIG. 2 such that the covering of the top turn of the central region passes through and plugs into / against the middle commissure (e.g., the inferior right commissure 24 shown in FIG. 2 at least a portion of the leading turn is located in a ventricle of the heart (e.g., the left ventricle 14 shown in FIG. 1 and at least a portion of the stabilizing turn is located in an atrium of the heart (e.g., the left atrium 12 shown in FIG. 1

[0414] As described above and shown in FIG. 33 and FIG. 17B During advancement, deployment, and positioning of the covered docking device, the distal tip of the distal section of the sleeve shaft can extend distally of the distal end of the docking device (e.g., beyond the distal end of the docking device), thereby providing the distal section of the sleeve shaft with an atraumatic tip that deforms and bends as it navigates around the native anatomy.

[0415] ​The method at 3306 can include flushing one or more lumens of the delivery system during deployment. The one or more lumens can include a first lumen disposed between a distal section of the sleeve shaft and the docking device, and a second lumen disposed between the outer shaft of the delivery system and the sleeve shaft, as described above with reference to FIGS. 19A-19B. FIG. 38

[0416] In some embodiments, flushing the first lumen can include providing the flushing fluid to a pushrod shaft lumen extending from a proximal end of a pushrod shaft disposed within a branch section of the hub assembly to a distal end of the pushrod shaft, where the suture lock is coupled to the branch section, the distal end being disposed proximate to but spaced apart from the proximal end of the docking device. Flushing the first lumen can further include flowing the flushing fluid through the pushrod shaft lumen and into and through the first lumen. In some embodiments, the flushing fluid can be provided to the pushrod shaft lumen via a flushing port coupled to the branch section distally of the suture lock. In alternative embodiments, the flushing fluid can be provided to the pushrod shaft lumen via a flushing port that is part of the suture lock and disposed at a proximal end of the suture lock.

[0417] In some embodiments, flushing the second lumen can include providing the flushing fluid to a first cavity formed between an outer surface of the pushrod shaft and an inner surface of the channel of the branch section (e.g., cavity 2254 shown in FIG. 22A), flowing the flushing fluid from the first cavity into a second cavity formed between the outer housing of the pushrod shaft and the sleeve shaft (e.g., cavity 1946 shown in FIG. 19A), and flowing the flushing fluid from the second cavity to the second lumen. FIG. 36 FIG. 37 In some embodiments, as described above, flushing the lumens of the delivery device can additionally occur in the process of preparing the delivery device for the implantation procedure prior to inserting the delivery device into the patient.

[0418] In some embodiments, as described above, flushing the lumens of the delivery device can additionally occur in the process of preparing the delivery device for the implantation procedure prior to inserting the delivery device into the patient.

[0419] At 3308, the method 3300 can include, after positioning the covered docking device, retracting the sleeve shaft in the proximal direction to expose the docking device. In some embodiments, retracting the sleeve shaft to expose the docking device can include moving a sleeve actuation handle of the delivery system in the proximal direction. The method at 3308 can further include maintaining a position of the pushrod shaft while retracting the sleeve shaft to expose the docking device, and retracting the pushrod shaft into the outer shaft of the delivery system after exposing the docking device.

[0420] The method 3300 can continue to 3310 to release (e.g., disconnect) the docking device from the delivery system. As described herein, the delivery system can include a suture lock assembly (e.g., suture lock 2206 of FIG. 22A and / or FIG. 24A FIG. 27A-FIG. 29E ​​​suture lock 2700), which includes a suture cutting location for cutting the suture (or other retrieval line), that extends from the suture lock through the delivery system and loops around one end of the docking device. In some embodiments, as referenced above with respect to FIG. 27A to FIG. 30C The method can include, at 3310, exposing the suture cutting location of the suture lock and cutting the suture using a cutting mechanism, such as FIG. 30A-FIG. 30C the mechanism shown), and then pulling the suture out of and away from the docking device. As a result, the docking device can be disconnected from the delivery system.

[0421] At 3312, the method 3300 can include deploying an artificial heart valve (e.g., one of the valves shown) inside the implanted docking device, as described herein. FIG. 3A-FIG. 8

[0422] A method of delivering a docking device according to certain embodiments is shown in FIG. 32A-FIG. 32C A method of delivering a docking device according to certain embodiments is shown in FIG. 32A Delivery of a docking device including a cover 100 is shown. In particular, FIG. 32A The sleeve or distal section is shown initially retracted into the delivery device. However, the cover 100 is not fully expanded and extends over a portion of the pusher shaft 1900. In this way, FIG. 32B The sleeve or distal section 1502 is shown partially reinserted to push the cover 100 into an expanded form, and FIG. 32C The sleeve or distal section is shown fully retracted into the delivery device with the cover 100 in the expanded form and no longer covering the pusher shaft 1900.

[0423] Additional steps described anywhere herein can also be added, and the systems and components described herein can be used with these methods. Any and all methods, operations, steps, etc. described herein can be performed on a living animal or an inanimate cadaver, cadaver heart, simulator (e.g., having a simulated human body part, tissue, etc.), anthropomorphic phantom, etc.

[0424] General considerations

[0425] For the purposes of this specification, certain aspects, advantages, and novel features of the embodiments of the present disclosure are described herein. The disclosed methods, apparatus, and systems should not be construed as limiting in any manner. Instead, the present disclosure is directed to all novel and non-obvious features and aspects of the various disclosed embodiments, alone and in various combinations and sub-combinations with one another. The methods, apparatus, and systems are not limited to any particular aspect or feature or combination of features, nor do the disclosed embodiments require the presence of any particular advantage or solve any problem.

[0426] ​Although the operations of some of the disclosed embodiments are described in a particular, sequential order for convenient presentation, it should be understood that this manner of description encompasses rearrangement, save for particular language that might follow in subsequent descriptions. For example, operations described sequentially can in some cases be rearranged or performed concurrently. Moreover, for the sake of simplicity, the attached figures can not show the various ways in which the disclosed methods can be used in conjunction with other methods. Additionally, the description sometimes uses terms like "provide" or "achieve" to describe the disclosed methods. These terms are high-level abstractions of the actual operations that are performed. The actual operations that correspond to these terms can vary depending on the particular implementation and are readily discernible by one of ordinary skill in the art.

[0427] As used in this application and in the claims, the singular forms “a,” “an,” and “the” include the plural forms unless the context clearly dictates otherwise. Additionally, the term “include” means “comprise.” Further, the terms “coupled” and “associated” generally mean electrically, electromagnetically, and / or physically (e.g., mechanically or chemically) coupled or linked, and do not exclude the presence of intermediate elements between coupled or associated items absent specific contrary language.

[0428] In the context of the present application, the terms “inferior” and “superior” are used interchangeably with the terms “inflow” and “outflow,” respectively. Thus, for example, the inferior end of a valve is its inflow end, while the superior end of a valve is its outflow end.

[0429] As used herein with respect to delivery systems, docking devices, and prosthetic heart valves, the term “proximal” refers to a position, direction, or portion of a device that is closer to a user and / or closer to a handle of a delivery system disposed outside a patient’s body and further from an implantation site. As used herein, the term “distal” refers to a position, direction, or portion of a device that is further from a user and / or a handle of a delivery system and closer to an implantation site. Thus, for example, proximal movement of a device is movement of the device toward a user, while distal movement of a device is movement of the device away from a user. Unless otherwise specifically defined, the terms “longitudinal” and “axial” refer to an axis that extends in a proximal and distal direction. Further, the term “radial” refers to a direction that is arranged perpendicular to the axis and points along a radius from a center of an object in which the axis is located at the center, such as a central longitudinal axis of a delivery system.

[0430] In view of the many possible embodiments to which the principles of the disclosed technology can be applied, it should be recognized that the embodiments shown are only preferred examples, and should not be taken as limiting the scope of the present disclosure. Rather, the scope of the present disclosure is broader than the embodiments, and encompasses all changes and modifications to the embodiments that would be obvious to one of ordinary skill in the art in light of the disclosure.

Claims

1. A suture lock assembly for a delivery system of an implantable medical device, characterized by Comprising: a spool configured to receive a suture and comprising a gear; a rotatable handle coupled to the spool and configured to rotate the spool and gear; a pawl configured to engage with teeth of the gear and allow the gear, spool, and handle to rotate in only one direction; and an orientation selector coupled to the pawl and movable between two positions, each of the two positions corresponding to a different direction of rotation of the gear, the orientation selector configured to pivot the pawl to adjust an orientation of the pawl relative to the gear and adjust the direction of rotation of the gear, wherein the pawl is pivotable between a first orientation that allows the gear to rotate in only a first direction and a second orientation that allows the gear to rotate in only a second, opposite direction, and wherein the pawl is held in the first orientation and the second orientation by a spring plunger that engages with the pawl at a back side of the pawl, and wherein the pawl is disposed on a first side of the spring plunger in the first orientation and on a second side of the spring plunger in the second orientation.

2. The suture locking assembly according to claim 1, wherein wherein the first direction is counterclockwise and the second direction is clockwise.

3. The suture locking assembly according to claim 1, wherein wherein the pawl comprises two teeth spaced apart from each other and disposed on a front side of the pawl, and wherein the two teeth of the pawl are configured to engage with teeth of the gear.

4. The suture locking assembly according to any one of claims 1 to 3, wherein further comprising a hard stop disposed within a housing of the suture locking assembly, the gear and pawl disposed within the housing, and wherein the pawl is configured to engage with one of the hard stops when the gear is rotated in a direction opposite the selected direction of rotation set by the orientation selector.

5. The suture locking assembly of any of claims 1-3, wherein further comprising a housing comprising a top housing and a bottom housing coupled to each other; the gear and pawl disposed within a space between the top and bottom housings; and the rotatable handle and the orientation selector extending outward from the top housing, wherein the top housing comprises a first icon indicating a relaxed position of the orientation selector and a second icon indicating a tensioned position of the orientation selector, and wherein the orientation selector is movable between a first position of the two positions pointing at the first icon and a second position of the two positions pointing at the second icon.

6. The suture locking assembly of any of claims 1-3, wherein further comprising a release lever comprising a suture cutting location disposed at a distal end of the release lever, the release lever configured to receive a suture through an interior of the release lever and through the suture cutting location, the suture extending from the spool.

7. The suture locking assembly according to claim 6, wherein wherein the release lever comprises one or more support ribs disposed on a central portion of the release lever, the central portion disposed between the distal end and a proximal end of the release lever.

8. The suture locking assembly according to claim 6, wherein wherein a distal end of the release rod is shaped to form a first keyed connection with an adapter of the delivery system, and a proximal end of the release rod is shaped to form a second keyed connection with a bottom housing of the suture locking assembly, wherein the spool is disposed within an interior of the bottom housing.

9. The suture locking assembly according to claim 8, wherein further comprising a flush port coupled to the bottom housing and extending outwardly therefrom in a direction opposite to a direction in which the release rod extends from the bottom housing.

10. The suture locking assembly according to any one of claims 7 to 9, wherein further comprising a plurality of annular sealing elements including a first annular sealing element disposed around a distal end portion of the release rod proximate to the suture cutting location, and a second annular sealing element disposed around a proximal end portion of the release rod, the second annular sealing element disposed between the release rod and the bottom housing of the suture locking assembly in a radial direction, wherein the spool is disposed within the bottom housing.

11. The suture locking assembly according to claim 10, wherein wherein the plurality of annular sealing elements further comprises a third annular sealing element disposed around a portion of the spool and disposed between the portion of the spool and the bottom housing.

12. The suture locking assembly according to any one of claims 7 to 9 and 11, wherein wherein a proximal end of the release rod is integrated to the bottom housing of the suture locking assembly.

13. The suture locking assembly according to any one of claims 7 to 9 and 11, wherein wherein the release rod comprises a divider disposed within the suture cutting location, wherein the divider is configured to separate two strands of suture extending longitudinally through the release rod and expose only one of the two strands of suture to an exterior of the suture locking assembly at the suture cutting location.

14. The suture locking assembly according to any one of claims 7 to 9 and 11, characterized in that wherein the spool comprises a gap in a flange disposed around a bottom of the spool, and wherein the rotatable handle comprises an indicator on an outer surface thereof, the indicator configured to track a number of turns applied to the spool and position the gap.

15. The suture locking assembly according to claim 14, wherein wherein the gap is disposed proximate to one or more orifices disposed within the spool, the one or more orifices configured to extend the suture from an interior of the spool to an outer surface of the spool, the outer surface of the spool configured to receive the suture thereon.

16. The suture locking assembly of any of claims 7-9, 11 and 15, wherein wherein the rotatable handle is coupled to the spool via a central screw extending longitudinally through the rotatable handle and the spool, the suture locking assembly further comprising one or more friction pads disposed around the central screw proximate to the central portion of the spool, and a friction nut coupled to the central screw below a lower friction pad of the one or more friction pads, and wherein the one or more friction pads are configured to increase friction on the central screw to stop rotation of the central screw and the rotatable handle when a tension in the suture increases above a predetermined threshold.

17. The suture locking assembly of any of claims 1-3, 7-9, 11, and 15, wherein Further comprising a pin-based clutch system including a spring plunger extending longitudinally through and coupled to a portion of the rotatable handle, the spring plunger of the pin-based clutch system including an end extending into the gear and configured to extend into and mate with a plurality of detents arranged in an outward-facing surface of the gear to allow the gear to be rotated by the rotatable handle, and wherein the spring plunger is configured to slide out of the detents in response to tension in the suture being above a predetermined threshold.

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