Systems, devices and methods for treating heart valves

Abstract

To provide a delivery system for ensuring safe and effective delivery.SOLUTION: Systems, assemblies, and methods for treating valve regurgitation and other valve problems are described. The prosthetic valve may have an integrated cover or flange. The prosthetic valve can have a flange that is attached to and designed to extend outwardly from the inflow end of the annular frame. The docking device can be used to repair or reshape a native heart valve and to secure a prosthetic heart valve in a particular location and position relative to the native heart valve. A delivery system, including a smooth sleeve on the delivery system, can be used to deploy the docking device into the heart. A packaging and storage system suitable for the delivery system is described.SELECTED DRAWING: Figure 24B

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of U.S. Provisional Patent Application No. 62 / 908,402, filed September 30, 2019, entitled "Systems, Devices, and Methods for Treating Heart Valves," and U.S. Provisional Patent Application No. 62 / 858,875, filed June 7, 2019, entitled "Systems, Devices, and Methods for Treating Heart Valves," the disclosures of which are incorporated by reference herein in their entireties.

[0002] The present disclosure relates to systems and methods for treating valvular regurgitation and / or other valvular problems. [Background technology]

[0003] Prosthetic heart valves can be used to treat valvular diseases of the heart. The natural heart valves (aortic, pulmonary, tricuspid, and mitral) perform a critical function in ensuring proper antegrade flow of blood supply through the cardiovascular system. These heart valves can become ineffective due to congenital, inflammatory, infectious, and other conditions. Such conditions can ultimately lead to serious cardiovascular damage or death.

[0004] Transcatheter techniques can be used to introduce and implant prosthetic heart valves using flexible catheters in a less invasive manner than open-heart surgery. In this technique, the prosthetic valve can be loaded in a crimped state onto the end portion of a flexible catheter and advanced through the patient's blood vessels until the valve reaches the implantation site. The valve at the distal end of the catheter can be expanded to its functional size at the site of the incompetent native valve, such as by inflating a balloon on which the valve is loaded. Alternatively, the valve can have a resilient, self-expanding stent or frame at the distal end of the catheter that expands the valve to its functional size when advanced from a delivery sheath. Optionally, the valve can have a mechanically expandable frame, or the valve can have a combination of expansion mechanisms, such as balloon-expandable, self-expandable, and / or mechanically expandable portions.

[0005] Transcatheter heart valves (THVs) can theoretically be appropriately sized or shaped to be placed inside the native mitral and tricuspid valves. However, the anatomy of the mitral and tricuspid valves can vary considerably from person to person, making it difficult to properly size and shape the valve for many patients. Furthermore, if the valve is inadequately treated, the surrounding tissue may not be strong enough to hold a particular type of valve in the desired position. It would be beneficial to have a docking system and / or device to secure the prosthetic valve in the proper position, as well as an appropriate delivery system to ensure safe and effective delivery. Additionally, the shape of the native valve may allow paravalvular leakage around the prosthetic valve (i.e., blood flow bypassing the prosthetic valve). Therefore, solutions to increase the efficiency of prosthetic valve placement and to reduce paravalvular leakage would be beneficial. [Prior art documents] [Patent documents]

[0006] [Patent Document 1] U.S. Patent No. 10,195,025 [Patent Document 2] US Patent Application Publication No. 2018 / 0206982 [Patent Document 3] U.S. Patent Application Serial No. 16 / 252,890 [Patent Document 4] U.S. Pre-grant Application Publication No. 2019 / 0374337(A1) [Patent Document 5] U.S. Pre-grant Application Publication No. 2019 / 0192296(A1) [Patent Document 6] U.S. Pre-grant Application Publication No. 2019 / 0046314(A1) [Patent Document 7] U.S. Pre-grant Application Publication No. 2018 / 0055628(A1) [Patent Document 8] US Patent Application Publication No. 2018 / 0318079 [Patent Document 9] US Patent Application Publication No. 2018 / 0263764 [Patent Document 10] US Patent Application Publication No. 2018 / 0177594 Summary of the Invention [Means for solving the problem]

[0007] This summary is meant to provide examples and is not intended to limit the scope of the invention in any way. For example, a feature included in the examples of this summary is not required by a claim unless the claim explicitly calls out that feature. This description discloses exemplary embodiments of a prosthetic valve, a docking station for the prosthetic valve, a delivery device for the docking station, and packaging for the delivery device. The docking station, catheter, and handle can be constructed in a variety of ways. Also, the described features can be combined in a variety of ways. Various features and steps described elsewhere in this specification may be included in the examples summarized here.

[0008] In some embodiments, the systems and / or apparatuses herein comprise a docking device (e.g., tether, etc.), a delivery system, a prosthetic or implantable heart valve, a pushing device, other components, or a combination of one or more of these. The docking device, delivery system, prosthetic valve, etc. may be the same as or similar to those described below or elsewhere herein.

[0009] In one exemplary embodiment, a suture locking assembly for a delivery system for an implantable medical device may include a spool configured to receive a suture and including a gear; a rotatable handle coupled to the spool and configured to rotate the spool and gear; a pawl configured to engage teeth on the gear and allow rotation of the gear, spool, and handle in only one direction; and a direction selection device coupled to the pawl and movable between two positions, each corresponding to a different direction of rotation of the gear, the direction selection device configured to adjust the orientation of the pawl relative to the gear and pivot the pawl to adjust the direction of rotation of the gear.

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

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

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

[0013] In some embodiments, the suture locking assembly further comprises hard stops disposed within a housing of the suture locking assembly, the gear and pawl being disposed within the housing, and the pawl being configured to interface with one of the hard stops when the gear is rotated in a direction that is opposite to the selected direction of rotation established by the direction selection device.

[0014] In some embodiments, the suture locking assembly further includes a housing including upper and lower housings coupled to one another, the gear and pawl being disposed in a space disposed between the upper and lower housings. The rotatable handle and the direction selection device can extend outward from the upper housing. The upper housing can include a first icon indicating a loose position of the direction selection device and a second icon indicating a tensioned position of the direction selection device, the direction selection device being movable between a first of two positions pointing toward the first icon and a second of two positions pointing toward the second icon.

[0015] In some embodiments, the suture locking assembly further comprises a release bar having a suture cut location disposed at a distal end thereof, the release bar configured to receive a suture through an interior of the release bar and across the suture cut location, the suture extending from the spool.

[0016] In some embodiments, the release bar comprises one or more support aids disposed in a central portion of the release bar, the central portion being disposed between the distal and proximal ends of the release bar.

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

[0018] In some embodiments, the suture lock assembly further comprises an irrigation port coupled to the lower housing and extending outwardly from the lower housing in a direction opposite to the direction that the release bar extends from the lower 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 bar proximate the suture cutting location and a second annular sealing element disposed about a proximal end portion of the release bar, the second annular sealing element being radially disposed between the release bar and a lower housing of the suture locking assembly, the spool being disposed within the lower 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 lower housing.

[0020] In some embodiments, the proximal end of the release bar is adhered to the lower housing of the suture lock assembly.

[0021] In some embodiments, the release bar includes a divider disposed within the suture cutting position, the divider configured to separate two lines of suture extending longitudinally through the release bar and expose only one of the two lines of suture outside the suture locking assembly at the suture cutting position.

[0022] In some embodiments, the spool includes a gap in a flange disposed around the bottom of the spool, and the rotatable handle includes an indicator on its outer surface configured to track the number of turns applied to the spool and to locate the gap.

[0023] In some embodiments, the gap is positioned adjacent to one or more openings disposed in the spool, the one or more openings configured to route the suture from an interior of the spool to an exterior surface of the spool configured to receive the suture.

[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 lock assembly may further include one or more friction pads disposed around the central screw adjacent a central portion of the spool, and a friction nut coupled to the central screw below a lower one of the one or more friction pads, The one or more friction pads are configured to increase friction at the central screw to stop rotation of the central screw and rotatable handle when tension on the suture increases beyond a predetermined threshold.

[0025] In some embodiments, the suture lock assembly further includes a pin-based clutch system extending longitudinally through a portion of the rotatable handle and including a spring plunger coupled to the portion of the rotatable handle, the spring plunger having an end extending into the gear configured to extend into and mate with a plurality of detents disposed on an outwardly facing surface of the gear to allow rotation of the gear by the rotatable handle. The spring plunger can be configured to slide out of the detents in response to a tension on the suture exceeding a predetermined threshold.

[0026] In another exemplary embodiment, a delivery system for delivering a docking device to a native valve annulus of a patient's heart may include an outer shaft and a sleeve shaft at least partially disposed within the outer shaft. The sleeve shaft may include a distal section configured to cover the docking device and including a flexible material with a smooth outer surface, and a proximal section including a rigid material and including a tubular portion and a cutting portion, the cutting portion having an open U-shaped cross-section. The delivery system may further include a pusher shaft at least partially disposed within the outer shaft, the pusher shaft including: a main tube disposed within the sleeve shaft in a radial direction relative to a central longitudinal axis of the delivery system; an annular outer shell surrounding a proximal end portion of the main tube and spaced radially from the outer surface of the main tube; and a proximal extension coupled to the proximal end of the main tube proximally of the outer shell and extending proximally from the proximal end of the main tube, the proximal extension including a flexible material and extending along a portion of an inner surface of the cutting portion of the proximal section of the sleeve shaft.

[0027] In some embodiments, the pusher shaft further comprises an annular plug disposed within the annular outer shell at the proximal end of the shell and surrounding the main tube, the plug comprising a crescent-shaped portion extending across and filling a first portion of the annular space disposed between the main tube and the outer shell.

[0028] In some embodiments, the annular space is open and includes a second portion that is not filled by the plug, the proximal section of the sleeve shaft is configured to slide within the annular space, and 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 the interface between the tubular portion and the cutting portion, the end face being disposed perpendicular to the central longitudinal axis, and the plug is configured to interface with the end face of the proximal section and stop the sleeve shaft from advancing further axially proximally.

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

[0031] In some embodiments, the sleeve shaft further comprises a flexible polymer jacket forming the outer surface of the distal section and the intermediate section, the flexible polymer jacket comprising a flexible material, an inner liner forming the inner surface of each of the distal section and the intermediate section, and a rigid tube including 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, the second section comprises a plurality of openings disposed around the circumference of the rigid tube along the second section, and the rigid tube is bonded to the inner liner and the flexible polymer jacket through the plurality of openings via an adhesive connection between the inner liner and the flexible polymer jacket.

[0033] In some embodiments, the delivery system further includes a handle assembly comprising a handle portion and a hub assembly extending proximally from a proximal end of the handle portion, the outer shaft extending distally from a distal end of the handle portion, and the hub assembly comprising an adapter with a straight section coupled to the suture locking assembly and a bifurcated 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 bifurcation section of the adapter.

[0035] In some embodiments, the delivery system further comprises a first flushing port coupled to the bifurcation section of the adapter and fluidly coupled to an internal lumen of the proximal extension of the pusher shaft, hi some embodiments, the delivery system further comprises a second flushing port coupled to the bifurcation section distal to the first flushing port and fluidly coupled to a lumen formed between an outer surface of the proximal extension and an internal surface of the bifurcation section.

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

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

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

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

[0040] In another exemplary embodiment, a delivery system for delivering a docking device to a native valve annulus of a patient's heart comprises a handle portion, an outer shaft extending distally from a distal end of the handle portion, a sleeve shaft extending through the interior of the outer shaft and configured to cover the docking device, a pusher shaft comprising a main tube extending through the interior of the sleeve shaft, and a hub assembly extending proximally from a proximal end of the handle portion. The hub assembly may include an adapter coupled to the handle portion and including a first section and a second section branching from the first section, with a portion of the pusher shaft extending into the second section and a proximal section of the sleeve shaft extending through the first section; a suture lock assembly coupled to the proximal end of the second section and configured to adjust tension on a suture extending from the adapter through the pusher shaft to the docking device; a first flushing port coupled to the second section and fluidly coupled to a first fluid flow lumen disposed within the pusher shaft and a second fluid flow lumen disposed between the sleeve shaft and the docking device; and a second flushing 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 comprises a sleeve actuation handle disposed at the proximal end of the first section and coupled to the end of the proximal section of the sleeve shaft, the sleeve actuation handle configured to adjust the axial position of the sleeve shaft relative to the outer shaft.

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

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

[0044] In some embodiments, the second flushing port is fluidly coupled to the third fluid flow lumen via an annular cavity disposed between the outer shell of the pusher shaft and the main tube of the pusher shaft and a fourth fluid flow lumen formed between the outer surface of the proximal extension and the inner surface of the second section, the fourth fluid flow lumen being fluidly coupled to the annular cavity. In some embodiments, the third fluid flow lumen is disposed between the inner surface of the outer shaft and a distal portion of the sleeve shaft, the distal portion being configured to cover the docking device while the docking device is disposed within 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 includes a gasket disposed within and spanning a diameter of the second section between where the first flushing port is coupled to the second section and where the second flushing port is coupled to the second section, the gasket being configured to fluidly separate the first and third fluid flow lumens.

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

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

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

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

[0051] In some embodiments, the delivery system further comprises a hemostatic seal disposed in the first section of the adapter proximate the sleeve actuation handle, the hemostatic seal comprising an opening surrounding a cut portion of the sleeve shaft 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 in the first section around the hemostatic seal, the locking cap assembly configured to apply inward pressure to the hemostatic seal to lock axial translation of the sleeve shaft relative to the remainder of the hub assembly.

[0052] In some embodiments, the pusher shaft is configured to deploy the docking device from inside the distal end portion of the outer shaft upon reaching 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 while the docking device is positioned within the outer shaft during guidance of the delivery system into the native valve annulus.

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

[0054] In one exemplary embodiment, a method for delivering a docking device to a native valve of a heart may include the steps of: deploying the docking device from a distal end of a delivery system, wherein the docking device is covered by a distal section of a sleeve shaft of the delivery system, the docking device comprising a coil extending along a central axis and including a central region including 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, the covering extending along and around the top turn of the central region, the top turn being disposed at the second end of the central region; positioning the covered docking device on the native valve such that the covering of the top turn of the central region occludes across a midcomissure of the native valve, at least a portion of the leading turn being positioned in a ventricle of the heart and at least a portion of the stabilizing turn being positioned in an atrium of the heart; and, after the step of positioning the covered docking device, retracting the sleeve shaft proximally to reveal 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 over the outer shaft of the delivery system with a pushing shaft of the delivery system.

[0056] In some embodiments, retracting the sleeve shaft to reveal the docking device includes moving a sleeve actuation handle proximally.

[0057] In some embodiments, the method may further include the steps of maintaining the position of the pushing shaft while retracting the sleeve shaft to reveal the docking device, and, after revealing the docking device, retracting the pushing shaft back into the outer shaft of the delivery system.

[0058] In some embodiments, the method may further include, between the steps of deploying the coated docking device and positioning the coated docking device at the native valve, flushing multiple lumens of the delivery system, including a first lumen disposed between the 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.

[0059] In some embodiments, the step of flushing the first lumen includes providing flushing fluid to a pusher shaft lumen extending through the pusher shaft from a proximal end of the pusher shaft disposed in a bifurcation section of the hub assembly to which the suture lock is coupled to a distal end of the pusher shaft, the distal end being disposed adjacent to but spaced apart from the proximal end of the docking device; and flowing the flushing fluid through the pusher shaft lumen and into the first lumen and through the first lumen.

[0060] In some embodiments, irrigation fluid is provided to the pusher shaft lumen through an irrigation port coupled to the bifurcation section distal to the suture lock.

[0061] In some embodiments, irrigation fluid is provided to the pusher shaft lumen through an irrigation port that is part of the suture lock and is located at the proximal end of the suture lock.

[0062] In some embodiments, the step of flushing the second lumen includes providing a flushing fluid to a first cavity formed between the outer surface of the pusher shaft and the inner surface of the conduit in the branched section, flowing the flushing fluid from the first cavity to a second cavity formed between the outer shell of the pusher shaft and the main tube of the pusher shaft, and flowing the flushing fluid from the second cavity to the second lumen.

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

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

[0065] In another representative embodiment, a method for providing irrigation fluid to a delivery system configured to deliver a docking device to a native valve of a heart may include the steps of: flowing irrigation fluid through an inner pusher shaft lumen extending through the interior of a pusher shaft of the delivery system to a distal end of the pusher shaft, the pusher shaft being coaxially disposed within and at least partially within a sleeve shaft of the delivery system, the sleeve shaft and pusher shaft being disposed within an outer shaft of the delivery system extending distally from a handle assembly of the delivery system, the sleeve shaft including a distal section that surrounds and covers the docking device within the outer shaft; flowing the irrigation fluid from the pusher 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 irrigation fluid through a delivery shaft lumen formed between the outer surface of the sleeve shaft and the inner surface of the outer shaft.

[0066] In some embodiments, flowing the irrigation fluid through the pusher shaft lumen and into the sleeve shaft lumen and flowing the fluid through the delivery shaft lumen comprises flowing the irrigation fluid sequentially from a common fluid source into the pusher shaft lumen, the sleeve shaft lumen, and the delivery shaft lumen.

[0067] In some embodiments, the steps of flowing the irrigation fluid through the push shaft lumen and into the sleeve shaft lumen and flowing the fluid through the delivery shaft lumen include sequentially flowing the irrigation fluid from a first fluid source into the push shaft lumen and the sleeve shaft lumen and sequentially flowing the irrigation fluid from a separate second fluid source into the delivery shaft lumen.

[0068] In some embodiments, the steps of flowing the irrigation fluid through the pusher shaft lumen into the sleeve shaft lumen and flowing the fluid through the delivery shaft lumen are performed while advancing the distal end portion of the delivery system, on which the docking device is located, toward the native valve and positioning the docking device at the native valve while covered by the sleeve shaft.

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

[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 a conduit of a hub assembly of the delivery system into a first cavity formed between an outer surface of the pusher shaft and an inner surface of the conduit, flowing the flushing fluid from the first cavity to a second cavity disposed between an inner surface of an outer shell of the pusher shaft and an outer surface of a main tube of the pusher shaft, and flowing the flushing fluid from the second cavity into the delivery shaft lumen.

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

[0072] In some embodiments, flowing the flushing fluid through the push shaft lumen and into the sleeve shaft lumen includes flowing the flushing fluid into the push shaft lumen from a second flushing port coupled to the conduit in direct fluid communication with the push shaft lumen, proximal to where the first flushing port is coupled to the conduit.

[0073] In some embodiments, the method may further include maintaining a flow of irrigation fluid from the first irrigation port to the first cavity separately from a flow of irrigation fluid from the second irrigation port to the pusher shaft lumen.

[0074] In some embodiments, a docking device for docking a prosthetic valve in a native heart valve comprises a coil extending along a central axis and including a leading coil, a central region, and a stabilizing coil, the central region carrying a plurality of turns having substantially equal inner diameters, the leading turn extending from one end of the central region and having a diameter larger than that of the central region, and the stabilizing turn having a diameter larger than that of the central region and extending from an end of the central region opposite the leading turn.

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

[0076] In some embodiments of the docking device, the stabilization turns are designed to lie lower in free space than the central region, thereby elevating the central region.

[0077] In some embodiments of the docking device, the stabilizing turns have a diameter that is larger than the opening of the native mitral valve, but small enough to bear against the plane of the mitral valve.

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

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

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

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

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

[0083] In some embodiments of the docking device, the covering possesses pores sized to be atraumatic to native tissue and to allow tissue ingrowth into the covering.

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

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

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

[0087] In some embodiments of the docking device, the central region configuration comprises at least three turns including a proximal turn, a distal turn, and at least one intermediate turn, wherein the proximal turn is the turn closest to the stabilizing turn and the distal turn is the turn closest to the leading turn, the central region forming a generally hourglass-shaped structure, and the distal turn and the proximal turn having a larger diameter than the at least one intermediate turn.

[0088] In some embodiments of the docking device, the central region configuration comprises at least three turns including a proximal turn, a distal turn, and at least one intermediate turn, wherein the proximal turn is the turn closest to the stabilizing turn and the distal turn is the turn closest to the leading turn, the central region forming a generally barrel-shaped structure, and the at least one intermediate turn having a larger diameter than the distal turn and the proximal turn.

[0089] In some embodiments of the docking device, the docking device comprises a flange created by connecting the stabilization turn to the next adjacent turn in the central region using fabric.

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

[0091] In some embodiments of the docking device, the radiopaque marker is located one-quarter turn around the leading turn.

[0092] In some embodiments, an implantable prosthetic heart valve comprises an annular frame having an inflow end and an outflow end, the annular frame being radially collapsible and expandable between a radially collapsed configuration and a radially expanded configuration, the annular 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 outward from the inflow end.

[0093] In some embodiments, the implantable prosthetic heart valve has a flange constructed from and / or including a memory material (eg, a shape memory alloy, a shape memory metal, Nitinol, etc.).

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

[0095] In some embodiments of the implantable prosthetic heart valve, the flange is attached to the annular frame with a fabric medium.

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

[0097] In some embodiments of the implantable prosthetic heart valve, the skirt is constructed from and / or comprises at least one of foam and fabric.

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

[0101] In some embodiments of the implantable prosthetic heart valve, the annular frame includes a memory material integrated with or positioned under the skirt to assist in the expansion of the skirt, which is fabricated using fabric and foam.

[0102] In some embodiments of the implantable prosthetic heart valve, the skirt possesses 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 carries a pocket for placement of embolic material.

[0104] In some embodiments of the implantable prosthetic heart valve, the pocket possesses a hole to allow for the insertion of embolic material.

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

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

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

[0108] In some embodiments of the system for implanting a docking device in a native valve, the sleeve shaft comprises a distal section, an intermediate section, and a proximal section, the distal section forming a smooth sleeve that covers the docking device, and the proximal section being used to actuate the position of the smooth sleeve.

[0109] In some embodiments of a system for implanting a docking device in a native valve, the lubricious sleeve is and / or includes a low friction material.

[0110] In some embodiments of the system for implanting a docking device in a native valve, the lubricious sleeve carries a hydrophilic coating.

[0111] In some embodiments of a system for implanting a docking device in a native valve, the lubricious sleeve carries a hydrogel coating.

[0112] In some embodiments of the system for implanting a docking device in a native valve, the proximal section is rigid and possesses a cutout portion to allow access to the pusher shaft.

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

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

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

[0116] In some embodiments of the system for implanting a docking device in a native valve, the distal section possesses a dense braid.

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

[0118] In some embodiments of the system for implanting a docking device in a native valve, the pusher shaft comprises a main hypotube having a distal end secured to the docking device and a proximal end opposite the distal end, an outer shell, a plug, and a proximal extension, the outer shell extending coaxially with the main hypotube and the sleeve shaft and welded to the proximal end of the main hypotube using the plug and positioned between the catheter and the sleeve shaft, and the proximal extension extending from the proximal end of the main hypotube.

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

[0120] In some embodiments of the system for implanting a docking device in a native valve, the shell and plug are welded to the main hypotube so that the cut portion of the sleeve shaft can be slid between the main hypotube and the outer shell.

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

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

[0123] In some embodiments of the system for implanting a docking device in a native valve, the Y-shaped connector has a straight section and a branched section, with the sleeve shaft extending to the end of the straight section and the proximal extension extending to the end of the branched section.

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

[0125] In some embodiments of the system for implanting a docking device in a native valve, the flushing port is configured so that multiple lumens formed between the catheter, the sleeve shaft, and the pusher shaft can be flushed simultaneously from a single port.

[0126] In some embodiments of the system for implanting a docking device in a native valve, the handle assembly is positioned in the formed straight section and includes a hemostatic seal having a first end positioned proximal to the opening in the form of a sleeve shaft.

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

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

[0129] In some embodiments of the system for implanting a docking device in a native valve, the first rigid washer and the second rigid washer apply inward pressure to 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 in a native valve, the handle assembly further comprises a locking cap assembly.

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

[0132] The present disclosure provides methods for delivering an implant to a native valve of the 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 on a native valve of the heart such that at least a portion of the leading turns of the docking device are positioned around one or more leaflets of the native valve in a ventricle of the heart. In certain embodiments, implantation of the docking device can act to reshape one or more tissues in the heart to restore function of the native valve. In some embodiments, the methods can include delivering the docking device to the native mitral valve to restore left ventricle function in relation to the heart. In some embodiments, the methods can reduce the diameter of the annulus and apply tension to the chordae. In some embodiments, the methods can further include performing an edge-to-edge repair on the native leaflets of the native mitral valve, such as by attaching a clip to attach the free edge of the anterior mitral leaflet to the free edge of the posterior mitral leaflet.

[0133] In some embodiments, the method may include delivering an implantable prosthetic heart valve into the docking device after the docking device is positioned on the heart's native valve at a desired location. The method 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 method includes an annular frame with an inflow end and an outflow end that is radially collapsible and expandable between a radially collapsed configuration and a radially expanded configuration, the annular frame defining an axial direction extending from the inflow end to the outflow end, a leaflet structure positioned within the frame and secured to the frame, and a flange designed to be attached to the inflow end of the annular frame and extend outward from the inflow end. In certain embodiments, the method may further include the steps of positioning the implantable prosthetic heart valve in a radially collapsed configuration within the docking device, and expanding the implantable prosthetic heart valve from the radially collapsed configuration to a radially expanded configuration such that a radially outward pressure is applied by the frame of the implantable prosthetic heart valve to at least a portion of a central region of the docking device.

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

[0135] In various embodiments, the methods may be performed in a living animal or a non-living cadaver, a cadaver heart, a simulator (e.g., a simulated body part, tissue, etc.), an anthropomorphic skeleton, or the like.

[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 explanation of the drawings]

[0137] [Figure 1] 1 is a schematic cross-sectional view of a human heart, according to various embodiments. [Figure 2] 1 is a schematic top view of a mitral valve annulus of a heart, according to various embodiments. [Figure 3A] 1A-1C are perspective views of an embodiment of a prosthetic heart valve carrying a flange, according to various embodiments. [Figure 3B] 1A-1C are side views of an embodiment of a prosthetic heart valve carrying a flange, according to various embodiments. [Figure 3C] 1A-1C are perspective views of example embodiments of prosthetic heart valves bearing commissural flanges, according to various embodiments. [Figure 4A] 1A-1C are diagrams of example embodiments of prosthetic heart valves bearing coverings, according to various embodiments. [Figure 4B] 1A-1C are diagrams of example embodiments of prosthetic heart valves bearing coverings, according to various embodiments. [Figure 4C] 1A-1C are diagrams of example embodiments of prosthetic heart valves bearing coverings, according to various embodiments. [Figure 5A] 10A-10C are diagrams of example embodiments having engraved overlays, according to various embodiments. [Figure 5B] 10A-10C are diagrams of example embodiments having engraved overlays, according to various embodiments. [Figure 5C] 10A-10C are diagrams of example embodiments having engraved overlays, according to various embodiments. [Figure 5D] 10A-10C are diagrams of example embodiments having engraved overlays, according to various embodiments. [Figure 5E] 10A-10C are diagrams of example embodiments having engraved overlays, according to various embodiments. [Figure 5F] 10A-10C are diagrams of example embodiments having engraved overlays, according to various embodiments. [Figure 6A] 1A-1C are side views of an embodiment of a prosthetic heart valve having a woven fabric covering, according to various embodiments. [Figure 6B] 1A-1C are side views of embodiments of prosthetic heart valves bearing hybrid coverings, according to various embodiments. [Figure 6C] 1A-1C are views of an embodiment of a prosthetic heart valve having a rim covering, according to various embodiments. [Figure 6D] 1A-1C are views of an embodiment of a prosthetic heart valve having a rim covering, according to various embodiments. [Figure 6E] 1A-1C are views of an embodiment of a prosthetic heart valve having a rim covering, according to various embodiments. [Figure 7A] 1A-1C are diagrams of a prosthetic heart valve having a flexible flange support, according to various embodiments. [Figure 7B] 1A-1C are diagrams of a prosthetic heart valve having a flexible flange support, according to various embodiments. [Figure 7C] 1A-1C are diagrams of a prosthetic heart valve having a flexible flange support, according to various embodiments. [Figure 8] 1A-1C are diagrams of a prosthetic heart valve having outward-extending struts, according to various embodiments. [Figure 9A] 1 is a top view of an example embodiment of a docking device or core of a docking device with three points of contact in the left atrium, according to various embodiments. [Figure 9B] 1 is a side view of an example embodiment of a docking device or core of a docking device with three points of contact in the left atrium, according to various embodiments. [Figure 9C] 1 is a side view of an example embodiment of a docking device or core of a docking device with three points of contact in the left atrium, according to various embodiments. [Figure 10A]FIG. 10 is a top view of an example embodiment of a docking device with flat stabilization or atrial wrapping, according to various embodiments. [Figure 10B] FIG. 10 is a top view of an example embodiment of a docking device with flat stabilization or atrial wrapping, according to various embodiments. [Figure 10C] 1A-1C are side views of example embodiments of docking devices or cores for docking devices with flat stabilization or atrial wrapping, according to various embodiments. [Figure 10D] 1A-1C are side views of example embodiments of docking devices or cores for docking devices with flat stabilization or atrial wrapping, according to various embodiments. [Figure 11A] 1 is a top view of an example embodiment of a hybrid docking device or core of a hybrid docking device, according to various embodiments. [Figure 11B] 1 is a side view of an example embodiment of a hybrid docking device or core of a hybrid docking device, according to various embodiments. [Figure 11C] 1 is a side view of an example embodiment of a hybrid docking device or core of a hybrid docking device, according to various embodiments. [Figure 12A] 1A-1C are top views of example embodiments of docking devices carrying a covering on the stabilizing or atrial wrap, according to various embodiments. [Figure 12B] 1A-1C are top views of example embodiments of docking devices carrying a covering on the stabilizing or atrial wrap, according to various embodiments. [Figure 12C] 1A-1C are top views of example embodiments of docking devices carrying a covering on the stabilizing or atrial wrap, according to various embodiments. [Figure 12D] 1A-1C are top views of example embodiments of docking devices carrying a covering on the stabilizing or atrial wrap, according to various embodiments. [Figure 12E] 1A and 1B are perspective views of example embodiments of docking devices having coatings on their functional windings, according to various embodiments. [Figure 12F] 12E is a cross-sectional view of a first portion of an envelope of the docking device of FIG. 12E, according to various embodiments. [Figure 12G] 12F is a cross-sectional view of a second portion of the envelope of the docking device of FIG. 12E according to various embodiments. [Figure 12H] 12E is a top or plan view of a mitral valve with the leaflets closed and coapted, indicating key anatomical landmarks and diagram lines that indicate features of the docking device of FIG. 12E, in accordance with various embodiments. [Figure 13A] 1 is a perspective view of an example embodiment of a docking device carrying an enclosure, according to various embodiments. [Figure 13B] 1 is a cross-sectional view of an example embodiment of a docking device having an enclosure, according to various embodiments. [Figure 13C] 1 is a cross-sectional view of an example embodiment of a docking device having an enclosure, according to various embodiments. [Figure 14A] 1 is a cross-sectional view of an example embodiment of a docking device having a soft covering, according to various embodiments. [Figure 14B] 1 is a cross-sectional view of an example embodiment of a docking device having a soft covering, according to various embodiments. [Figure 14C] 1 is a schematic close-up diagram of a soft covering bond according to various embodiments. [Figure 15A] 1A-1C are side views of example embodiments of docking devices possessing an hourglass shape in a central region, according to various embodiments. [Figure 15B] 1A-1C are side views of example embodiments of docking devices possessing an hourglass shape in a central region, according to various embodiments. [Figure 15C] 1A-1C are side views of example embodiments of docking devices that possess a barrel shape in a central region, according to various embodiments. [Figure 15D] 1A-1C are side views of example embodiments of docking devices that possess a barrel shape in a central region, according to various embodiments. [Figure 16]1A-1C are perspective views of example embodiments of docking devices having flanges on the stabilizing or atrial wrap, according to various embodiments. [Figure 17A] 1A-1C are diagrams of example embodiments of sleeve shafts, according to various embodiments. [Figure 17B] FIG. 17B is a cross-sectional side view of the sleeve shaft of FIG. 17A. [Figure 17C] FIG. 17C is a detailed view of a portion of the sleeve shaft of FIG. 17B showing the interface between the different materials of the sleeve shaft. [Figure 17D] FIG. 17C is a side view of an example embodiment of a flexible polymer jacket of the sleeve shaft of FIG. 17B. [Figure 17E] FIG. 17C is a side view of an example embodiment of a stiffer tube portion of the sleeve shaft of FIG. 17B. [Figure 18] 1A-1C are diagrams of example embodiments of layer structures of a lubricious sleeve, according to various embodiments. [Figure 19] 17C is a side cross-sectional view of an example embodiment of a flexible tip for the sleeve shaft of FIG. 17B. [Figure 20A] 10A-10C are side views of example embodiments of proximal sections of sleeve shafts, according to various embodiments. [Figure 20B] 10A-10C are perspective views of example embodiments of stiffer tube portions of the proximal section of the sleeve shaft, according to various embodiments. [Figure 20C] 20C is a perspective view of an example embodiment of an interface between the tube portion of FIG. 20B and an inner liner at a proximal section of a sleeve shaft, according to various embodiments. [Figure 20D] 20D is a perspective view of an example embodiment of an outer flexible polymer layer disposed over the tube portion at the proximal section of the sleeve shaft and the inner liner of FIG. 20C, according to various embodiments. [Figure 21A] 1 is a cross-sectional view of a first side of an example embodiment of a pusher shaft, according to various embodiments. [Figure 21B] FIG. 10 is a cross-sectional view of a second side of an example embodiment of a pusher shaft, according to various embodiments. [Figure 21C]FIG. 21C is a detailed view of the distal end of the pusher shaft of FIG. 21B. [Figure 21D] FIG. 21C is a view of the proximal end of the pusher shaft of FIG. 21B. [Figure 21E] FIG. 21C is a side view of the tube portion of the pusher shaft of FIG. 21B. [Figure 21F] FIG. 21C is a side view of the outer shell of the pusher shaft of FIG. 21B. [Figure 21G] FIG. 21C is an end view of the plug of the pusher shaft of FIG. 21B. [Figure 22A] 10A-10C are diagrams of example embodiments of an interoperating sleeve shaft and pusher shaft, according to various embodiments. [Figure 22B] 10A-10C are diagrams of example embodiments of an interoperating sleeve shaft and pusher shaft, according to various embodiments. [Figure 22C] 10A-10C are diagrams of example embodiments of an interoperating sleeve shaft and pusher shaft, according to various embodiments. [Figure 23A] 12A-12C are side views of example embodiments of proximal extensions of pusher shafts, according to various embodiments. [Figure 23B] 23B is a perspective view of a pusher shaft including the proximal extension of FIG. 23A. FIG. [Figure 24A] 1A-1C are diagrams of example embodiments of a portion of a handle assembly for a delivery system for a docking device, according to various embodiments. [Figure 24B] FIG. 1 is a diagram of an example embodiment of a delivery system for a docking device. [Figure 25] 1A-1C are diagrams of example embodiments of cleaning plates, according to various embodiments. [Figure 26A] 1A-1C are diagrams of example embodiments of hemostatic seals, according to various embodiments. [Figure 26B] 1A-1C are diagrams of example embodiments of hemostatic seals, according to various embodiments. [Figure 27A] 1A-1C are views of an example embodiment of a portion of a handle assembly for a delivery system including a suture lock and a sleeve handle, according to various embodiments. [Figure 27B]FIG. 27B is a perspective view of the suture lock of FIG. 27A decoupled from the branch of the handle assembly. [Figure 27C] FIG. 27B is an exploded view of the suture lock of FIG. 27A. [Figure 28A] 27A-27C, including a flushing port at the proximal end of the suture lock. FIG. [Figure 28B] FIG. 27D is a perspective view of a detailed portion of the suture lock of FIGS. 27A-27C, showing the release knob and internal release bar. [Figure 28C] FIG. 28C is a side cross-sectional view of the release bar of the suture lock of FIG. 28B. [Figure 28D] FIG. 28D is a perspective view of the release bar of FIGS. 28B and 28C. [Figure 28E] FIG. 28D is a detailed cross-sectional view of the suture cutting portion of the release bar of FIGS. 28B-28D. [Figure 29A] 10A-10C are views of example embodiments of directional mechanisms for suture locks, according to various embodiments. [Figure 29B] 10A-10C are views of example embodiments of directional mechanisms for suture locks, according to various embodiments. [Figure 29C] 10A-10C are views of example embodiments of directional mechanisms for suture locks, according to various embodiments. [Figure 29D] 10A-10C are views of example embodiments of directional mechanisms for suture locks, according to various embodiments. [Figure 29E] 10A-10C are views of example embodiments of directional mechanisms for suture locks, according to various embodiments. [Figure 30A] 10A-10C are diagrams of example embodiments of suture severing and removal mechanisms, according to various embodiments. [Figure 30B] 10A-10C are diagrams of example embodiments of suture severing and removal mechanisms, according to various embodiments. [Figure 30C] 10A-10C are diagrams of example embodiments of suture severing and removal mechanisms, according to various embodiments. [Figure 31A] 1A-1C are diagrams of example embodiments of coil holders, according to various embodiments. [Figure 31B]1A-1C are diagrams of example embodiments of coil holders, according to various embodiments. [Figure 32A] 10A-10C illustrate methods for extending a covering over a docking device, according to various embodiments. [Figure 32B] 10A-10C illustrate methods for extending a covering over a docking device, according to various embodiments. [Figure 32C] 10A-10C illustrate methods for extending a covering over a docking device, according to various embodiments. [Figure 33] 10A and 10B are perspective views of an example embodiment of a sleeve shaft covering a docking device that extends over the delivery catheter of a delivery system. [Figure 34] 34 is a view of the sleeve shaft surrounding the pusher shaft after the docking device has been deployed from the delivery system of FIG. 33 and the sleeve shaft has been removed from the docking device. [Figure 35] FIG. 10 is a side cross-sectional view of a portion of the handle assembly and fluid flow through the lumen of the handle assembly. [Figure 36] 36 is a perspective cross-sectional view of a more detailed portion of the handle assembly of FIG. 35 and fluid flow through the lumens of the handle assembly. [Figure 37] FIG. 1 is a perspective cross-sectional view of a portion of a delivery system including a pusher shaft and a sleeve shaft arranged coaxially with one another and fluid flow through a lumen disposed between the coaxial components. [Figure 38] 1 is a schematic diagram of fluid flow through the lumen of a distal end portion of a delivery system, the delivery system comprising a pusher shaft disposed on its outer shaft, a sleeve shaft, and a docking device. [Figure 39] 1 is a flow diagram of a method for delivering a docking device to a native valve of a heart and implanting the docking device and associated prosthetic heart valve in the native valve. DETAILED DESCRIPTION OF THE INVENTION

[0138] Disclosed herein are various systems, devices, methods, etc., including anchoring or docking devices that can be used in conjunction with an expandable prosthetic valve (e.g., a transcatheter heart valve (THV)) in a native valve annulus (e.g., a mitral or tricuspid annulus) to more securely implant and retain the prosthetic valve at the implantation site. Anchoring / docking devices according to embodiments of the present invention provide or form a more circular and / or suitable anchoring site, landing zone, or implantation zone at the implantation site where the prosthetic valve can be expanded or implanted. Many of these docking devices and prosthetic valves have circular or cylindrically shaped valve frames or stents that can be expanded or implanted into locations with a naturally circular cross-section. However, additional embodiments of docking devices and prosthetic valves have other shapes (e.g., oval, oval, elongated, curved, etc.) that are more suited to non-circular and / or non-cylindrical anatomy. In addition to providing an anchoring site for the prosthetic valve, the anchoring / docking device can be sized and shaped to clamp or pull the anatomy of the native valve (e.g., mitral valve, tricuspid valve, etc.) radially inward. In this manner, one of the major causes of valve regurgitation (e.g., functional mitral regurgitation), specific hypertrophy of the heart and / or annulus (e.g., left ventricular hypertrophy, etc.), and the resulting stretching of the native valve (e.g., mitral valve) annulus can be at least partially counteracted or countered. Some embodiments of the anchoring or docking device further include features that are shaped and / or modified to, for example, better retain the position or shape of the docking device during and / or after expansion of the prosthetic valve. By providing such an anchoring or docking device, replacement valves can be more securely implanted and retained in various valve annuli, including mitral annuli that do not have a naturally shaped cross-section.

[0139] 1 and 2, a mitral valve 10 controls the flow of blood between the left atrium 12 and the left ventricle 14 of a 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 to the left ventricle 14. When the left ventricle 14 contracts, the oxygenated blood held in the left ventricle 14 is delivered to the rest of the body through the aortic valve 16 and the aorta 18. However, the mitral valve must close during ventricular contraction to prevent blood from flowing back into the left atrium.

[0140] When the left ventricle contracts, blood pressure in the left ventricle increases substantially, causing the mitral valve to close. Due to the pressure difference between the left ventricle and the left atrium during this time, a large degree of pressure is exerted on the mitral valve, potentially causing prolapse or eversion of the mitral valve leaflets back into the atrium. Therefore, a series of chordae tendineae 22 connect the mitral valve leaflets to the papillary muscles located in the wall of the left ventricle, and both the chordae tendineae and the papillary muscles are tensioned to hold the leaflets in a closed position during ventricular contraction and prevent the leaflets from extending back toward the left atrium. This helps prevent backflow of oxygenated blood back into the left atrium. The chordae tendineae 22 are shown schematically in both the cross-section of the heart in FIG. 1 and the top view of the mitral valve in FIG. 2.

[0141] The general shape of the mitral valve and its leaflets as viewed from the left atrium is shown in FIG. 2. A commissure 24 is located at the end of the mitral valve 10 where the anterior leaflet 26 and posterior leaflet 28 come together. Various complications of the mitral valve can potentially cause fatal heart failure. One form of heart valve disease is mitral valve leak or mitral valve regurgitation, which is characterized by abnormal leakage of blood from the left ventricle back into the left atrium through the mitral valve. This can be caused, for example, by left ventricular distention, which causes the native mitral valve leaflets to not fully coapt and result in leakage; by damage to the native valve leaflets; or by weakening (or damage to) the chordae tendineae and / or papillary muscles. In these situations, it may be desirable to repair the mitral valve or replace its functionality with that of a prosthetic heart valve.

[0142] The field of transcatheter aortic valve replacement has grown significantly more than transcatheter mitral valve replacement and has achieved widespread success. This difference is due to the fact that mitral valve replacement is more challenging than aortic valve replacement in many respects, including, for example, the non-circular physical structure of the mitral valve, the anatomy of the mitral valve subannulus, and more difficult access to the valve. Additionally, the mitral valve often lacks calcification, limiting the ability of a prosthetic valve to anchor within it.

[0143] One of the most significant obstacles to mitral valve replacement is effectively anchoring or retaining the valve in the mitral position because the valve is subjected to significant cyclical loads. As previously mentioned, another problem with mitral valve replacement is the size and shape of the native mitral valve annulus, as seen in Figure 2. The aortic valve is more circular or cylindrical in shape than the mitral valve. Additionally, both the mitral and tricuspid valves are larger and more elongated in shape than the aortic valve, making them more challenging and unconventional sites for implanting replacement valves with generally circular or cylindrical valve frames. A prosthetic valve that is too small can result in leakage around the implant (i.e., paravalvular leakage) if a good seal is not established around the valve, while a prosthetic valve that is too large can stretch and damage the narrower portions of the native mitral valve annulus. Furthermore, in many cases, the need for aortic valve replacement arises due to aortic valve stenosis, in which the aortic valve narrows due to, for example, calcification or other sclerosis of the native valve leaflets. Therefore, the aortic annulus generally provides a more compact, rigid, and stable anchoring site for a prosthetic valve than the mitral annulus, which is larger and more non-circular. Instances of mitral regurgitation are unlikely to provide such a good anchoring site. Additionally, the presence of chordae tendineae and other anatomical structures at the mitral valve level can create obstacles that make properly anchoring a device at the mitral valve much more difficult.

[0144] Other obstacles to effective mitral valve replacement can result from the large cyclic loads experienced by the mitral valve, which require establishing sufficiently strong and stable anchorage and retention, and even slight misalignments in valve alignment can result in obstruction or other adverse effects on blood flow through the valve or other parts of the heart.

[0145] Prosthetic Valve Embodiments Prosthetic valves according to example embodiments are shown in Figures 3A-6B. While specific examples of prosthetic heart valves are discussed herein, the general structure, methods of manufacture, and methods of use of various prosthetic valves that may 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 Application Publication No. 2018 / 0206982, entitled "Covered Prosthetic Heart Valve," and U.S. Patent Application No. 16 / 252,890, entitled "Covered Prosthetic Heart Valve," the disclosures of each of which are incorporated by reference herein in their entireties.

[0146] 3A and 3B show an example prosthetic valve 30 according to various embodiments, in which a flange 32 is attached to the atrium (inflow end) 34 of the prosthetic valve 30 and extends radially outward 360°. In many of these embodiments, the flange 32 is designed to bear against the plane of the native valve, such as the plane of the native mitral valve or tricuspid valve. The flange 32 in some embodiments is designed to encourage flow through the prosthetic valve 30 to prevent and / or reduce paravalvular leakage. FIG. 3C shows a prosthetic valve 30 with flanges 32 and 32′ designed to cover only the commissures of the mitral valve rather than the entire plane of the mitral valve. Flanges 32 and 32′ that cover only the commissures can beneficially reduce the retracted or compressed size of the valve due to a slimmer profile during delivery, but may require repositioning or adjustment of the prosthetic valve 30 during deployment. In various embodiments, flange 32 (or flanges 32 and 32′) is made from a resilient material that can be compacted in a catheter for delivery. In certain embodiments, flange 32 (or flanges 32 and 32′) is made from and / or includes a memory material that can be compressed or manipulated and returns to a particular shape when the force is removed. An example of a memory material is nitinol (or NiTi), although other shape memory alloys or metals may be used. The memory material may be formed into a weave or frame that is compressible and returns to its formed shape (e.g., flange) when released from the catheter. In some embodiments, flange 32 is attached to the frame of the prosthetic valve via a fabric medium 36.

[0147] 4A-4B , exemplary embodiments of a prosthetic valve 40 are shown having a covering 42, such as a skirt, on its outer surface. 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 promote tissue ingrowth, and / or for other purposes. Due to the generally D-shape of the mitral valve (see FIG. 2 ) and its relatively large annulus compared to the aortic valve, the covering 42 acts as a seal around the prosthetic valve 40 (e.g., when the valve is sized smaller than the annulus) and allows for smooth coaptation of the native valve leaflets against the prosthetic valve 40. In various embodiments, the covering 42 is made of a material that can be collapsed for transcatheter delivery of the prosthetic valve and can be 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, the covering is attached via looped stitches 63, as shown in Figure 4A, while additional embodiments utilize edge covering strips 65 with radial horizontal stitches, as shown in Figure 4B. The edge covering strips 65 of many embodiments are constructed from any suitable material that is biocompatible and atraumatic to native tissue, including ePTFE, bovine pericardium, porcine pericardium, equine pericardium, woven PTFE, knitted PTFE, braided PTFE, polyurethane, electrospun ePTFE, dipped thermoplastics, sprayed thermoplastics, other organic tissues, other non-organic tissues, and combinations thereof.

[0148] Referring to FIG. 4C , some embodiments of the covering (e.g., cloth, fabric, etc.) solution form a pocket 46, such as a cup- or bag-shaped pocket, to allow insertion, injection, or encapsulation of embolic material after valve deployment and allow free exchange of fluid with native blood. Certain pocket-containing embodiments include one or more holes 44 in the covering layer to expand the outer layer during cardiac contraction. In some embodiments, the encapsulated material may provide an expansion mechanism. Certain embodiments expand by receiving blood from the atrial side of the prosthetic valve. In additional embodiments, holes 44 or ports allow insertion of embolic material with limited exposure to native blood, while further embodiments completely or nearly completely encapsulate the embolic material. In some encapsulated embodiments, the skirt can possess a permeable or semi-permeable covering to allow fluid exchange between the embolic material and blood. In some embodiments, the embolic material is injected through a catheter or syringe. Further embodiments use warping and / or buckling of the monofilament to expand the pocket. An example of monofilament warping is discussed further herein in connection with FIG.

[0149] In some embodiments, the embolic material is a hydrogel. Some hydrogels expand at body temperature; therefore, by selecting a body temperature expandable hydrogel, the patient's natural heart can provide expansion of the hydrogel around the prosthetic valve, preventing paravalvular leakage. Further embodiments possess hydrogels that expand upon absorbing fluids, such as blood. In such embodiments, the hydrogel can be inserted into the skirt prior to deployment of the valve, and the presence of blood after deployment will cause the hydrogel to expand. Additional embodiments utilize precipitating compositions, such as ethylene vinyl alcohol (EVOH) dissolved in dimethyl sulfoxide (DMSO). Certain EVOH-DMSO compositions are known in the art, including ONYX® LIQUID EMBOLIC SYSTEM™ (Micro Therapeutics, Inc., Irvine, California, USA) formulations of ONYX® 18 (6% EVOH), ONYX® 34 (8% EVOH), ONYX® HD-500 (20% EVOH), or mixtures thereof. In such embodiments, the EVOH-DMSO composition is inserted into the skirt after or during valve deployment. The DMSO in these compositions is carried away by the blood, leaving the EVOH behind, thereby forming an embolism and preventing paravalvular leaks.

[0150] In certain embodiments, the embolic material can be n-butyl cyanoacrylate. Some suitable embolic materials can be alkyl-2-cyanoacrylate monomers that, upon contact with ionic media (e.g., water, blood), form flexible polymers capable of forming adhesions to soft tissues. These liquid monomers, once isolated, are non-sticky, radiolucent, and rapidly polymerize. In certain embodiments, the embolic material can be a multi-component formulation including a cyanoacrylate and a radiopaque material, iodized poppy oil ethyl ester, or both. In some embodiments, additional components can increase polymerization time and render the liquid agent opaque, allowing visualization under fluoroscopy. Certain n-butyl cyanoacrylates are known in the art, including the TRUFILL® n-butyl-2-cyanoacrylate (n-BCA) liquid embolic system (DePuy Synthes Companies, Raynham, Massachusetts, USA).

[0151] In further embodiments, the embolic material may include one or more radiopaque materials that provide visualization under fluoroscopy. In certain embodiments, the radiopaque material may include one or more salts, compounds, or nanoparticles containing iodine, barium, tantalum, bismuth, or gold. In some embodiments, the radiopaque material may be tantalum powder.

[0152] Embodiments incorporating a foam solution provide a covering attached to the exterior of the valve frame to provide a substantial paravalvular leak solution while maintaining a small, collapsed profile that allows the device to be delivered via a catheter. In certain embodiments, one or more foam materials can be used to achieve a small device profile during collapse, provide expansion at the mitral valve, and provide a soft, smooth surface to interface with the native mitral valve. Possible foam materials include polyethylene terephthalate, polyurethane, and polyurethane-polycarbonate matrices intended for long-term implantation. Foams can be advantageous over fabric coverings because they can typically be compressed to a smaller collapsed profile, and the amount of expansion at the mitral valve is substantially more effective in reducing the amount of paravalvular leak due to the increased volume of the foam. Foams can also be highly conformable and atraumatic to the mitral valve anatomy. Additional benefits of foams include tissue ingrowth and echogenicity. The tissue ingrowth benefit occurs because foams are typically more porous than other materials, and porosity can better or allow for improved tissue ingrowth. The improved echogenicity is advantageous because it allows users, such as physicians, cardiologists, surgeons, and other medical professionals, to see the placement of the prosthetic valve based on where the foam expands.

[0153] The covering for a prosthetic valve can be further modified to allow for variations in the inflow and outflow portions of the prosthetic valve (e.g., the shape need not always be perfectly cylindrical, as shown previously), as seen in FIGS. 5A-5F. In these figures, a frame 50 possesses a covering 52 that is machined, thermoformed, or fabricated into a desired shape to allow for a larger outer diameter at the inflow portion 54. Various embodiments will possess specific shapes, as shown in FIGS. 5A-5F. Some embodiments possess a generally conical shape, as shown in FIG. 5A, having a larger outer diameter at the inflow portion 54 and gradually tapering to a smaller outer diameter at the outflow portion 56. Another set of embodiments possesses a curved, tapering covering 52, such as that in FIG. 5B, in which the covering 52 is thicker near the inflow portion 54 and possesses a generally curved taper toward the outflow portion 56.

[0154] Additional embodiments possess a generally hourglass shape, such as those shown in Figures 5C-5E. As shown in Figure 5C, some embodiments possess larger outer diameters at the inflow and outflow portions 54, 56, while possessing a narrower outer diameter at the mid-portion 58 of the prosthetic valve 50. Another shape of the covering portion 52 used in some embodiments is shown in Figure 5D, in which the covering portion 52 is set back slightly from the inflow portion 54 of the prosthetic valve 50 and possesses a larger outer diameter toward the inflow portion 54. Additionally, the covering portion 52 possesses a larger outer diameter at the outflow portion 56 and a smaller outer diameter at a location 58 proximal to the outflow portion 56. Figure 5E shows an embodiment in which the covering portion 52 possesses a constriction 53 designed to prevent foam compression from affecting the volume and / or shape of the first portion 57. Because the constriction 53 is designed to prevent compression of the first portion 57, the constriction 53 may be located anywhere along the body to achieve this purpose. For example, the constriction 53 can be adjacent to the inlet portion (as shown), or it can be located adjacent to the outlet portion 56, or it can be located at an intermediate location between the outlet portion 56 and the inlet portion 54. In many of these embodiments, the constriction 53 is a machined slit. In many embodiments with a constriction 53, the overall shape of the covering portion 52 is cylindrical (e.g., similar to FIG. 4A), although many embodiments will add contours or other shapes to the covering portion 52. For example, as shown in FIG. 5E, the first portion 57 has a gradual increase in thickness from the inlet portion 54, and the second portion 59 has a generally curved taper toward the outlet portion 56.

[0155] 5F, a further embodiment of prosthetic valve 50 has a covering portion 52 with a generally mushroom shape, with covering portion 52 having a first portion 57 with a curved increase in thickness from inflow portion 54 toward location 58. Covering portion 52 also has a second portion 59 extending from location 58 toward outflow portion 56 and having a generally cylindrical shape.

[0156] It should be noted that while some of the embodiments shown in Figures 5A-5F are shown with looped stitches and other embodiments are shown with edge strips and radial horizontal stitches, these illustrations are not meant to limit the type of stitching to any particular embodiment, and many embodiments will possess looped stitches or edge strips, independent of the shape of the covering portion 52 on the prosthetic valve 50.

[0157] 6A , some embodiments of covered valve 60 have a covering made from a woven cloth or fabric having multiple float regions 61 (e.g., protruding or puff regions). Details of exemplary covered valves with multiple float regions 61 are further described in U.S. Pre-Grant Application Publication Nos. 2019 / 0374337(A1), 2019 / 0192296(A1), and 2019 / 0046314(A1), the disclosures of which are incorporated herein in their entirety for all purposes. In certain embodiments, the float regions are separated by one or more horizontal bands 63. In many embodiments, the horizontal bands 63 are constructed via a 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 possessing a large degree of expansion, such as bulky weft yarns, while the horizontal fibers in a leno weave (e.g., extending circumferentially around the valve 60) comprise yarns or fibers with a small degree of expansion.

[0158] The float yarn region 61 can be heat set to achieve a desired size and texture, e.g., to make it softer and more textured. Bulk can be achieved by twisting, heat setting, and untwisting the constituent fibers of the yarn / thread used in region 61 so that the fibers retain their deformed and twisted shape, creating a bulky fabric. In some embodiments, the float yarn region 61 can be formed from textured PET without a woven structure. In certain embodiments, the covering portion of the covered valve 60 can be heat shrunk to achieve a stretchability between 80-160%.

[0159] In various embodiments, the woven fabric resembles greige fabric when assembled and tensioned (e.g., when stretched longitudinally in a compressed valve 60 prior to delivery of the valve 60). When the valve 60 is deployed and expanded, the tension on the floats 61 is relaxed, allowing the floats 61 to expand. In many embodiments, the number and size of the floats 61 are optimized to provide a degree of expansion to prevent paravalvular leakage across the plane of the mitral valve (e.g., to have a greater degree of expansion thickness) and / or to provide a smaller collapsed profile (e.g., for valve delivery), as further described in U.S. Pregrant Application Publication Nos. 2019 / 0374337(A1), 2019 / 0192296(A1), and 2019 / 0046314(A1). Band 63 may also be optimized to allow attachment of the covering to the valve based on the particular size or location of the struts or other structural elements in the valve.

[0160] In some embodiments, a covered valve 60 (e.g., as shown in FIG. 6B ) possesses a hybrid covering 62 that may comprise multiple different types of coverings working together. In the example shown in FIG. 6B , a first portion 64 of the hybrid covering 62 near the inflow portion 66 of the valve 60 comprises a foam or other expandable material, while a second portion 68 of the hybrid covering 62 near the outflow portion 69 of the valve 60 comprises a woven cloth or fabric that may have one or more expandable portions 61. Additionally, in FIG. 6B , the foam or other expandable material has a larger expanded profile in the inflow portion to increase its ability to form a seal and prevent paravalvular leakage around the plane of the mitral valve. Due to the compressibility of the foam / expandable material combined with the low-profile capabilities of the woven fabric, this foam-fabric hybrid skirt beneficially achieves a low profile when the valve is retracted. The expanded valve extends radially outward at the inflow end to enable a good paravalvular seal.

[0161] FIG. 6B also illustrates variations in the edge covering 65. Specifically, the edge covering 65 in many embodiments has a series of apertures 67 disposed therein (FIGS. 6C-6E). In certain embodiments, the apertures can be created via die cutting, laser cutting, punching, or any other method of creating apertures in the material of the edge covering 65. Looking at FIGS. 6C and 6D, a perspective view of the inflow portion 66 (FIG. 6C) and a perspective view of the outflow portion 69 (FIG. 6D) are shown. As can be seen in these figures, the edge covering 65 will have apertures 67 at both ends of the prosthetic valve in many embodiments. Additionally, FIG. 6E illustrates a perspective view from inside the outflow portion 69, illustrating the edge covering 65 with a series of apertures 67. As shown in FIG. 6E, the frame 63 of the prosthetic valve in many embodiments has angled struts that allow for compressibility around a catheter or other delivery device. The openings 67 are cut to line up between the apexes in the frame 63. By locating the openings between the apexes, when the prosthetic valve of certain embodiments is crimped around a catheter or other delivery device, the edge covering 65 does not bulge, thereby minimizing the outer diameter of the crimped valve.

[0162] While the various embodiments shown in Figures 3A-6F are described as being of foam and / or woven fabric, additional embodiments are constructed from materials that can provide the same effect, including woven PET, knitted PET, braided PET, woven PTFE, knitted PTFE, braided PTFE, ePTFE membrane, electrospun ePTFE, thermoplastic membrane, dipped thermoplastic, sprayed thermoplastic, foam, and combinations thereof.

[0163] In some embodiments, prosthetic valves with coverings utilize a material disposed under and / or incorporated into the covering that can be compressed or manipulated and return to a specific shape when the force is removed. FIGS. 7A-7B show a flange support structure 71 that allows the covering to expand to its full position. Specifically, FIGS. 7A-7B show the flange support structure 71 secured to the frame 63 in many embodiments. In some embodiments, the flange support structure 71 is secured at a mid-section 73 of the frame 63 near the inflow section 72. In some embodiments, securing is accomplished via stitching, welding, or any other suitable method for securing the flange support structure 71 to the frame 63. In some embodiments, the flange support structure 71 possesses a series of windows 75 that allow the flange support structure 71 to bulge radially outward from the frame 63, allowing the covering to expand to its maximum position. FIG. 7C shows an embodiment of a prosthetic valve with the flange support structure 71 in a collapsed position within a delivery device, such as a catheter. In FIG. 7C , the compressed frame 63 and flange support structure 71 do not significantly increase the outer diameter (double-headed arrow) of the retracted frame 63. The flange support structure 71 may be constructed from any suitable material, such as one that is biocompatible and / or atraumatic to native tissue. In certain embodiments, the flange support structure 71 is constructed from ePTFE. Additionally, the number of windows 75 disposed in the flange support structure 71 may be any number that allows the flange support structure 71 to bulge outward from the frame 63. In some embodiments, eight windows are cut, although additional embodiments possess 10, 12, 16, 24, or more windows.

[0164] In additional embodiments, such as that shown in FIG. 8 , outward struts 77 are positioned on the frame 63 in many embodiments, expanding via warping and / or buckling of the monofilament. In many of these embodiments, the outward struts 77 are constructed from a memory material, such as Nitinol, and are placed under or incorporated into the foam or cloth / fabric, where the memory material can assist in the resilient expansion of the covering. In many embodiments, any number of outward struts 77 can be positioned at a predetermined location to allow for expansion of the covering. While some embodiments position the outward struts 77 in three locations around the frame 63, additional embodiments position the outward struts 77 in four, six, or eight locations around the frame 63. In some embodiments, two outward struts 77 are coupled to the frame 63 at approximately the same location and extend outward from the frame 63 in a generally V-shaped configuration, while other embodiments have a single outward strut 77 at a specific location extending outward from the frame 63. While Figure 8 illustrates expansion on or near the atrial or inflow side of frame 63, a similar mechanism is used to expand the pocket covering on the ventricular or outflow side of frame 63 to assist in expanding the pocket to contain blood or embolic material (see Figure 4C).

[0165] It should be noted that the embodiments shown in Figures 3A-8 are exemplary and are not meant to be exclusive or limiting in any other embodiments where the illustrated features are not incombinable. For example, some embodiments incorporate a foam covering such as that shown in any of Figures 4A-6A and / or a flange support structure such as that shown in Figures 7A-7C with a flange as shown in any of Figures 3A-3C.

[0166] Docking Device Tethering / docking devices (e.g., docks) according to example embodiments of the invention are shown in FIGS. 9A-16 and may have a coiled shape. It is possible that certain docking devices in the atrioventricular position may migrate farther or deeper into the ventricle after deployment of the docking device than desired. Avoiding excessive “dock drop” can be beneficial to help avoid paravalvular leaks, for example, sealing the docking device and prosthetic valve together higher on the native leaflets to prevent paravalvular leaks that may occur if the docking device is placed lower on the chordae tendineae. Higher placement (e.g., by avoiding dock drop) can also aid in long-term valve stability because the leaflets are thicker and more robust near the annulus than at their distal ends, which is believed to provide stronger anchoring at or near the annulus and provide longer-term stability. Additionally, higher placement of the prosthetic valve can help avoid abrasion of the valve against native tissue (e.g., against the native valve leaflets and / or chordae) by reducing the likelihood of the prosthetic valve rubbing against the leaflets and / or chordae.

[0167] Paravalvular leaks can occur for several reasons, including when the native annulus is too large compared to the prosthetic valve, when the commissural leaflets are too short and / or damaged, when implantation of the docking device does not fully capture the native leaflets, when traversal of the docking device from one side of the valve to the other results in a small gap (e.g., at the commissures), when the prosthetic valve is positioned too laterally, anteriorly, posteriorly, and / or medially, and / or when there is an anatomical abnormality in a particular patient (e.g., a cleft, one associated with degenerative mitral regurgitation, etc.). Various embodiments of this disclosure are designed to offset, avoid, reduce, and / or eliminate many of these problems, including by maintaining dock-up on both sides of the native mitral valve (thus reducing and / or preventing dock drop by maintaining the dock and prosthetic valve closer to the plane of the native annulus), by creating a better seal around the prosthetic valve, by creating a better seal above the native annulus, etc. For example, Figures 9A-9C show versions of a dock or dock core configured to provide one or more points or regions of contact between the dock and the left atrial wall, such as at least three contact points in the left atrium or complete contact with the left atrial wall; Figures 10A-10C show a flat dock or flat dock core whose atrial portion lies in the plane of the mitral valve; and Figures 11A-11C show a hybrid dock or hybrid dock core in which stabilizing or atrial turns create a ring around the deployed prosthetic valve to seal the valve and reduce paravalvular leakage. In the example of Figures 9A-11C, the docking device 70 includes a coil or coiled portion with multiple turns extending along the central axis of the docking device 70. The coil or coiled portion can be continuous or extend in a generally helical manner with various differently sized and shaped sections, as described in more detail below. The docking device 70 shown in Figures 9A-11C can be configured to fit in the mitral valve position, but in other embodiments, it can be similarly or differently shaped and / or adapted for better accommodation in other native valve positions, such as in the tricuspid valve.Advantageously, the docking device configuration of the present disclosure can provide engagement with native anatomy that can provide increased stability and reduced relative motion between the docking device, the prosthetic valve docked thereto, and the native anatomy. Such reduced relative motion can prevent material degradation of the docking device and / or the prosthetic valve components docked thereto, and can prevent damage / trauma to the native tissue.

[0168] The docking device 70 of many embodiments comprises a central region 80 with a coil, coiled portion, or multiple coils (e.g., two coils, three coils, four coils, between two and five coils, or more). The coiled portions or coils of the central region 80 can be of similar size and shape, or can vary in size and / or shape. In some implementations, the central region 80 comprises three or approximately three complete coil turns having substantially equal inner diameters. The central region 80 of the docking device 70 serves as a primary landing or holding area for holding the expandable prosthetic valve when the docking device 70 and valve prosthesis are implanted into the patient's body. In some embodiments, the docking device 70 has a central region 80 with more or fewer coil turns, depending, for example, on the patient's anatomy, the degree of vertical contact desired 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 coils of the central region 80 may also be referred to as "functional coils" or "functional turns" because the properties of these coils contribute most to the magnitude of the retention force generated between the valve prosthesis, the docking device 70, and the native mitral valve leaflets and / or other anatomical structures.

[0169] Various factors can contribute to the overall retention force between the docking device 70 and the prosthetic valve retained therein. A primary factor is the number of turns included in the functional coil, but other factors include, for example, the inner diameter of the functional coil, frictional forces (e.g., between the coil and the prosthetic valve), and the strength of the prosthetic valve and the radial force the valve exerts on the coil. The docking device can have various numbers of coils and / or turns. The number of functional turns can range from slightly more than half a turn to five turns, from one full turn to five turns, or more. In one embodiment with 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, the atrial portion of the docking device can have one-half to three-quarters of a turn, or one-half to three-quarters of a circle. Although a range of turns is provided, as the number of turns in a docking device is reduced, the dimensions and / or material of the coil and / or wire from which the coil is made may also vary to maintain adequate retention. For example, the diameter of the wire may be larger and / or the diameter of the turns of the functional coil in a docking device with fewer coils may be larger. There may be multiple coils in the atrium and ventricle.

[0170] The size of the functional coil or coils in the central region 80 is generally selected based on the size of the desired THV to be implanted into the patient. Generally, the inner diameter 90 of the functional coil / turn (e.g., the coil / turn in the central region 80 of the docking device 70) is smaller than the outer diameter of the expandable heart valve, so that when the prosthetic valve is expanded in the docking device, an additional radial pulling or retention force acts 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 assembly's ability to handle mitral valve pressures of approximately 180 mmHg. For example, based on hemodynamic data using a prosthetic valve with an expanded outer diameter of 29 mm, a retention force of at least 15.8 N may be required between the docking device and the prosthetic valve to securely hold the prosthetic valve in the docking device and to resist or prevent valve regurgitation or leakage. However, under this example, to meet the 15.8N holding force requirement with any substantial reliability, the target average holding force must be substantially greater, for example, approximately 30N.

[0171] In many embodiments, the retention force between the docking device and the valve prosthesis is significantly reduced when the difference between the outer diameter of the prosthetic valve in its expanded state and the inner diameter of the functional coil is less than about 5 mm, because the reduced size difference may be too small to create sufficient retention force between the components. For example, in one embodiment, when a prosthetic valve with an expanded outer diameter of 29 mm was expanded in a set of coils with an inner diameter of 24 mm, the observed retention force was about 30 N, but when the same prosthetic valve was expanded in a set of coils with an inner diameter of 25 mm (e.g., only 1 mm larger), the retention force was observed to drop significantly to only 20 N. Therefore, in some embodiments, to create sufficient retention force between the docking device and a 29 mm prosthetic valve, the inner diameter of the functional coil (e.g., the coil in the central region 10 of the docking device 1) should be 24 mm or less. Often, the inner diameter of the functional coil (e.g., central region 80 of docking device 70) should be selected to be at least about 5 mm smaller than the prosthetic valve selected for implantation, however, various factors can affect retention, so if other sizes or size ranges are used, other features and / or characteristics (e.g., friction-enhancing features, material properties, etc.) can be used to provide better retention.

[0172] However, the diameter of the functional coil should be selected based on a consideration and balancing of several factors to achieve optimal results. For example, the native anatomy between the mitral valve annulus and the papillary muscle heads in the plane of the mitral valve forms a rough trapezoid, and the tissue of the mitral valve leaflets is thicker near the mitral valve plane and thinner below the mitral valve plane. A smaller diameter in the central region 80 may cause the docking device 70 to be placed further below the mitral valve plane than desired (a similar effect may be observed in the tricuspid valve). When docking occurs where the mitral valve leaflets are thinner, this may result in a suboptimal anchoring position for the prosthetic valve. Therefore, size, diameter, and other features that help retain the prosthetic valve higher in the leaflets may be beneficial. Additionally, the size of the inner diameter of the functional coil or central region 80 may be selected to draw the native anatomy closer together to at least partially counteract or neutralize valvular regurgitation caused by stretching of the native annulus as a result of, for example, left ventricular enlargement.

[0173] It is noted that the desired retention forces discussed above are applicable to embodiments for mitral valve replacement. As such, other embodiments of the docking device used for replacement of other valves may have different sizing relationships based on the desired retention forces for the valve replacement in their respective positions. The sizing differences may also vary based on the materials used for the valve and / or docking device, for example, whether there are any other features to prevent functional coil expansion or to enhance friction / locking, and / or a variety of other factors.

[0174] In embodiments in which the docking device 70 is used in the mitral valve position, the docking device can be first advanced and delivered to the native mitral valve annulus and then set in place prior to implantation of the prosthetic heart valve. In some embodiments, the docking device 70 is flexible and / or made from a shape-memory material so that the coil of the docking device 70 can be straightened for delivery via a transcatheter approach. In some embodiments, the coil is made from other biocompatible materials, such as stainless steel. The same catheter and other delivery tools can be used for delivery of both the docking device 70 and the prosthetic valve without the need to perform separate preparation steps, simplifying the implantation procedure for the end user.

[0175] Because the functional coil / turn or turns of the central region 80 of the docking device 70 are kept relatively small in diameter (e.g., the central region 80 in one embodiment may have an inner diameter of approximately 21-24 mm (e.g., ±2 mm) or another diameter smaller than the prosthetic valve and / or native annulus) to increase retention with the prosthetic valve, it may be difficult to advance the docking device 70 around the existing leaflets and / or chordae tendineae and to a desired position relative to the native mitral annulus. This is especially true if the entire docking device 70 is made to have the same small diameter as the central region 80. As such, the docking device 70 can have a distal or lower region 82 that includes and / or consists of a leading coil / turn (sometimes referred to as a surrounding turn or leading ventricular coil / turn) of the docking device 70, the distal or lower region 82 having a diameter that is greater than the diameter of the functional coil / turn or coil / turn of the central region 80.

[0176] Native anatomy features have varying dimensions, particularly in the right and left ventricles. For example, the native mitral valve anatomy may have a maximum width in the long axis of approximately 35 mm to 45 mm. The diameter or width of the surrounding turns or leading coil / turn (e.g., ventricular coil / turn) in the lower region 82 may be selected to be larger to more easily guide the distal or leading tip 84 of the docking device 70 around features of the native anatomy (e.g., the valve leaflets and / or chordae tendineae) and surround the native anatomy.

[0177] Various sizes and shapes are possible; for example, in one embodiment, the diameter can be anywhere from 25 mm to 75 mm. The term "diameter" as used in this disclosure does not require the coil / turn to be a complete or perfectly formed circle, but is generally used to refer to the maximum width across the coil / turn from one point to the other. For example, for a leading coil / turn, the diameter may be measured from the distal tip 84 to the other end as if the lower region or leading coil / turn 82 formed a complete turn, as shown as diameter 91 in FIG. 9A. Alternatively, the diameter may 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 surround anatomical features within the ventricle, including the leaflets and chordae of the mitral valve, 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., diameter 90 shown in FIG. 10A). Further embodiments are designed to be atraumatic to other ventricular anatomy, including the intraventricular wall or septum, such that the diameter 91 of the lower region 82 is small enough not to contact the wall or septum. In certain embodiments, the diameter 91 of the lower region 82 ranges from approximately 33 to 37 mm (e.g., ±2 mm). In one embodiment, the lower region 82 (e.g., the leading coil / turn) of the docking device 70 has a diameter 91 of 43 mm or approximately 43 mm (e.g., ±2 mm); stated another way, the radius of curvature of the leading coil / turn can be 21.5 mm or approximately 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 of 16.25-16.75 mm).

[0178] Having a leading coil / turn with dimensions larger than the functional coil can help guide the coil more easily around and / or through the shape of the chordae tendineae, and most importantly, around both native valve leaflets of a native valve (e.g., native mitral valve, tricuspid valve, etc.). Once the distal tip 84 is guided around the desired native anatomy, the remaining coils of the docking device 70 can be guided around the same feature. In some embodiments, the size of the other coils can be small enough to pull the surrounded biologic features radially inward or slightly radially inward. Meanwhile, the length of the enlarged lower region 82 or leading coil / turn can be kept relatively short to prevent or avoid obstructing or interfering with blood flow along the ventricular outflow tract by the lower region 82 or leading coil / turn. For example, in one embodiment, the enlarged lower region 82 or leading coil / turn extends across only about half of the annulus or turn. With the lower region 82 or leading coil / turn having this relatively short length, when the prosthetic valve is expanded into the docking device 70 and the coils of the docking device 70 begin to unravel slightly due to the size difference between the docking device and the prosthetic valve, the lower region 82 or leading coil / turn can also be retracted and shift slightly. Under this example, after expansion of the prosthetic valve, the lower region 82 or leading coil / turn can be similar in size and substantially line up with the functional coils of the docking device 70 rather than continuing to protrude away from the functional coils, thereby reducing potential flow disturbances. Other docking device embodiments can have longer or shorter lower regions depending on the specific application.

[0179] In various embodiments, the docking device 70 shown in FIGS. 9A-11 includes a stabilizing coil / turn (which may be, for example, an atrial coil / turn) of the docking device 70 and / or also includes an enlarged proximal or upper region 86 consisting of the stabilizing coil / turn. During temporary or intermediate stages of the implantation procedure, i.e., the time between deployment and release of the docking device 70 and final delivery of the prosthetic valve, the coil may be displaced and / or displaced from its desired position or orientation, for example, by normal cardiac function. Displacement of the docking device 70 could potentially result in less reliable implantation, displacement, and / or other positioning issues with the prosthetic valve. Stabilizing features or coils can be used to help stabilize the docking device in the desired position. For example, docking device 70 may include upper region 86 with enlarged stabilizing coils / turns (e.g., enlarged atrial coils / turns having larger diameters 92 and / or 94 than the functional coils) intended to be positioned in the circulatory system (e.g., the left atrium) so that they can stabilize the docking device. For example, upper region 86 or the stabilizing coils / turns may be configured to abut or press against the wall of the circulatory system (e.g., the wall of the left atrium) to improve the ability of docking device 70 to remain in a desired position prior to implantation of the prosthetic valve.

[0180] The stabilization coil / turn (e.g., atrial coil / turn) in the upper region 86 of the docking device 70 in the illustrated embodiment can extend for approximately one full turn or rotation, terminating at the proximal tip 88. In other embodiments, the stabilization coil / turn (e.g., atrial coil) can extend for more or fewer turns or rotations, depending, for example, on the degree of contact desired between the docking device and the circulatory system (e.g., the left atrium) in each particular application. The radial size of the stabilization coil / turn (e.g., atrial coil) in the upper region 86 can also be significantly larger than the size of the functional coil in the central region 80, such that the stabilization coil / turn (e.g., atrial coil or atrial turn) flares or extends outward sufficiently to contact the wall of the circulatory system (e.g., the wall of the left atrium). Additionally, the stabilization coil / turn of various embodiments is configured to reduce rubbing against native tissue and / or anatomy. For example, the surface texture may be made smoother and / or softer so that movement of the docking device relative to the native anatomy does not damage the native tissue.

[0181] The proximal tip 88, as shown in these figures, also includes an eyelet or eyelet. The eyelet at the proximal tip is used to secure the docking device 70 to a delivery system through various means, including sutures (as described below). Various embodiments that include an eyelet at the proximal tip 88 thereby utilize eyelets of different shapes and sizes, with some embodiments utilizing larger eyelets while others use smaller eyelets. Also, the shape varies in certain embodiments, with some embodiments having round eyelets while others utilizing D-shaped eyelets. Furthermore, various embodiments, such as those shown, do not have eyelets but rather have holes drilled in the docking device itself, such as laser-drilled holes.

[0182] 9A-9C, these figures depict the docking device, but also depict core materials that may be coated and / or added to form the docking device. The stabilization coil 86 is designed to create a plane formed by at least three points of contact in the atrium. These three anchoring locations or points of contact are the posterior shelf of the native valve (e.g., the mitral valve), the anterior wall of the atrium, and either the atrial appendage or the lateral shelf of the native valve. This plane formed by the three points of contact is parallel to the plane of the native valve, which will maintain a docking position parallel to the plane of the native valve. In some embodiments, the diameter of the stabilization coil is desirably larger than the valve annulus, the plane of the native valve, and the atrium for better stabilization, but the stabilization coil is flexible with a thin, weak cross-section to prevent damage to the patient's atrium over long-term placement of the docking device 70.

[0183] Suitable materials for the docking device include a nitinol core, with core sizes ranging from approximately 0.3 mm to approximately 1 mm. A flexible core allows the stabilization coil to conform to the varying shapes and sizes of the atria. In some embodiments with a three-point-of-contact design, such as those shown in Figures 9B and 9C, the stabilization coil is designed to sit lower in free space than the functional coil when unconstrained (e.g., not placed on the patient's native valve), or to cross downward over the functional coil. This can beneficially elevate the functional coil (central region 80) relative to the native anatomy, the plane of the native valve, and the valve leaflets when implanted. For example, a stabilization coil that crosses from the proximal side of the central region or functional coil to or toward the distal side of the central region / functional coil, when deployed in the atrium, presses down in the plane of the atrium and / or native valve, causing the central region / functional coil to lift or urge upward so that it is higher on the ventricular side of the valve and higher under the valve leaflets.

[0184] 10A-10D, these figures depict a docking device, but also depict core materials that may be coated and / or added to form the docking device. In FIGS. 10A-10D, docking device 70 is designed with a flat stabilization coil 86 that lies in the plane of the native valve (e.g., in the plane of the native mitral valve or the plane of the native tricuspid valve). In these embodiments, stabilization coil 86 is designed to be larger than the opening of the native valve (e.g., the mitral or tricuspid valve), but not so large that the stabilization coil 86 is not in the plane of the native valve. The stabilization coil 86 can form a continuous curve, such as that shown in FIG. 10A, or can be flared or biased toward the posterior wall of the atrium, as seen in FIG. 10B, thereby utilizing a posterior shelf to prevent docking device 70 from dropping into the ventricle prior to deployment of a prosthetic or prosthetic valve therein. Also, in certain flat embodiments, the stabilization coil has a smooth cover to prevent trauma to native anatomy in areas that exhibit relative motion (e.g., where the docking device 70 crosses from the atrium to the ventricle through the mitral valve).

[0185] 11A-11C, these figures depict a docking device, but also depict core materials that may be coated and / or added to form the docking device. In FIGS. 11A-11C, a hybrid dock design configured to improve paravalvular leak prevention and / or suppression is shown. In this hybrid docking device 70 embodiment, the stabilization coil 86 is designed to create a tighter annulus around the deployed prosthetic valve, thereby helping to seal the valve and prevent paravalvular leaks. In some embodiments, this sealing effect is maximized by offsetting the dock core radially outward from the maximum valve outer diameter plus half the cross-section of the docking device. In some embodiments, the stabilization coil 86 allows for the maximum outer diameter (e.g., optimal contact with the atrium) to aid in docking drop prior to prosthetic valve deployment. Additionally, in some embodiments, the docking device is configured such that the stabilization coil is implanted and flush with the outer diameter of the expanded prosthetic valve after prosthetic valve deployment. This hybrid design can be manufactured to accommodate different prosthetic valve outer diameters to prevent paravalvular leakage around the prosthetic valve. For example, the docking device can be designed to accept valves with an outer diameter of approximately 30 mm or approximately 34 mm, or any diameter therebetween. The diameter of the docking device 70 can also be adjusted to accommodate prosthetic valves with outer diameters ranging from approximately 20 mm to approximately 50 mm.

[0186] In some embodiments, the various docking devices herein have a sufficiently small cross-section during delivery to fit inside the catheter / sleeve / sheath of the delivery device (discussed in more detail below), but are configured to expand after deployment to maximize the OD after implantation and create an improved seal around the prosthetic valve. Some embodiments also comprise and / or utilize materials configured to optimize tissue ingrowth (e.g., with pores and / or other openings to provide a larger available surface area to help encourage such ingrowth). In some embodiments, the pores and / or openings are approximately 30 μm to 1000 μm in size, which can encourage optimal tissue ingrowth. Tissue ingrowth can enable improved sealing and better integration with the native valve anatomy to stabilize the docking device and prosthetic valve and prevent chafing and / or damage over time. In certain embodiments, the docking device may comprise a material having openings (eg, pores) with sizes in the range of about 400-800 μm, 500-750 μm, 500-660 μm, 600-650 μm, or 625-650 μm.

[0187] Various docking devices herein may also incorporate additional modifications to the functional coil (e.g., central region 80 in FIGS. 9A-11C) and / or stabilizing coil (e.g., section 86 in FIGS. 9A-11C) to improve the functionality of the docking device. Examples of some such additional modifications are shown in FIGS. 12A-16.

[0188] 12A-12G show examples of possible coverings 100 that can be disposed on all or only a portion of a docking device (e.g., docking device 70 as shown in FIGS. 9A-11C or elsewhere herein) to form a seal on the prosthetic valve and reduce paravalvular leakage. In many embodiments, covering 100 covers predominantly or only a portion of the stabilization turn / coil (e.g., atrial turn / coil). In some embodiments, covering 100 is attached to the atrial turn and extends toward the functional turn in a central region and / or extends in a portion of the functional turn. In some embodiments, covering 100 is attached to the functional turn and extends toward the atrial turn. Certain embodiments possess covering 100 only in the functional turn. In some embodiments, covering 100 extends across the entire docking device 70. When in the stabilizing coil / turn or the atrial coil / turn, the covering 100 can help cover the atrial side of the atrioventricular valve to prevent and / or inhibit blood leakage through the native valve leaflets, commissures, and / or around the outside of the prosthetic valve by preventing blood in the atrium from flowing in the atrium in a direction from the atrium to the ventricle other than 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 in a thin profile, and an expanded configuration in which the covering 100 is expanded to a larger outer diameter (which can beneficially help prevent and / or inhibit paravalvular leakage).

[0189] In some embodiments, the covering 100 can expand to a diameter of approximately 5 mm (e.g., ±4 mm) to prevent and / or inhibit paravalvular leakage. In some embodiments, the covering 100 is configured to expand so that an improved seal is formed closer to and / or against the currently deployed prosthetic valve (such as that previously described in FIGS. 11A-11C). In some embodiments, the covering 100 is configured to prevent and / or inhibit leakage where the docking device 70 crosses between the leaflets of the native valve (e.g., without the covering 100, the docking device might push the leaflets apart at the crossing location, allowing leakage at that location (e.g., along the docking device or its sides), but the covering 100 can be configured to expand to cover and / or fill any openings at that location and inhibit leakage along the docking device).

[0190] In some embodiments, the covering 100 may comprise and / or consist of an expandable foam, as shown, for example, in FIG. 12A . In some embodiments, the covering comprises and / or consists of an expandable foam that is a memory foam so that it expands to a specific or preset shape upon removal of the collapse pressure prior to delivery of the docking device 70. Examples of such foams include 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 to 2 mm to 7 mm in the region of the covering. Alternatively, in some embodiments utilizing a foam, the foam is atraumatic to native anatomy and has pores large enough to allow tissue ingrowth.

[0191] In some embodiments, the covering 100 comprises a non-foam structure that is expandable over the docking device 70. For example, as shown in FIG. 12B , the covering 100 may comprise a braided structure over the docking device 70. The braided structure may be stretched inside the sleeve or covering before deployment of the docking device 70, but after deployment, the braided structure may be allowed to expand to its maximum possible diameter to create a seal. In some embodiments, the braided structure is a braided shape memory material (e.g., a shape memory alloy, a shape memory metal, Nitinol, etc.) that has a set shape and / or is pre-configured to expand to a particular shape and / or size when unconstrained and deployed in the native valve.

[0192] 12C, the covering 100 in some embodiments comprises multiple layers of the same and / or different materials. In these embodiments, the covering (braided, foam, or expandable non-foam structure) may be covered with a second covering 102. In these embodiments, the second covering 102 is designed to be atraumatic to native tissue and / or to promote tissue ingrowth into the second covering 102 and possibly the covering 100. The second covering may be constructed from any suitable material, including foam, cloth, fabric, and / or polymer, that is flexible to allow compression and expansion of the first covering 100 and second covering 102.

[0193] Movement between the docking device 70 and the sheath 100 can cause trauma to the native tissue, so some embodiments of the docking device 70 incorporate means for limiting movement, thereby reducing the risk of trauma to the native tissue. Looking to FIG. 12D , an embodiment of a sheathed docking device with a braided stabilizing coil 86 is shown. In embodiments such as that shown in FIG. 12D , the braided texture in the dock's stabilizing coil 86 can interact with the sheath 100 that surrounds the stabilizing coil 86. By creating an interaction between the stabilizing coil 86 and the sheath 100, movement of the docking device 70 can be reduced, limiting trauma to the native tissue.

[0194] In FIG. 12E, an embodiment of the docking device 70 is shown with the covering 100 in a functional coil in the central region of the docking device. As in the example shown in FIG. 12B, the covering 100 can comprise a braided structure over the docking device 70. The braided structure can be stretched inside the sleeve or covering before deployment of the docking device 70, but after deployment, the braided structure can be allowed to expand to its maximum possible diameter to create a seal. In some embodiments, the braided structure is a braided shape-memory material (e.g., a shape-memory alloy, a shape-memory metal, Nitinol, etc.) that has a set shape and / or is pre-configured to expand to a particular shape and / or size when unconstrained and deployed in the native valve. As shown in FIG. 12E, the docking device 70 can have an extension 140 positioned substantially between a central region 142 having functional windings and an upper region 144 having atrial windings. As described elsewhere herein, docking device 70 may have a lower region 146 having surrounding turns with a larger diameter relative to the functional turns in central region 142. In FIG. 12E , extension 140 is made from or comprises a vertical section of a coil that extends substantially parallel to the central axis of docking device 70. In some embodiments, extension 140 may be angled relative to the central axis of docking device 70, but generally serves as a vertical or axial spacer that separates adjacent connecting portions of docking device 70 in the vertical or axial direction, such that a vertical or axial gap is formed between the coil portions on either side of extension 140 (e.g., a gap may be formed between the upper or atrial side and the lower or ventricular side of docking device 70). In certain embodiments, the extension portion 140 is intended to be positioned at or near the anterior lateral commissure AC when the docking device 70 is implanted, with the covering portion 100 positioned across the plane of the mitral annulus so that a portion of the covering portion 100 is positioned at the posterior medial commissure PC.Additional details of exemplary configurations of the docking device 70 having the extension portion 140 can be found in U.S. Pre-Grant Application Publication No. 2018 / 0055628(A1), the entirety of which is incorporated herein for all purposes.

[0195] In FIG. 12E, an embodiment of the docking device 70 is shown with the covering 100 extending over the functional turns of the central region. In such an embodiment, the covering 100 can help cover the ventricular side of the atrioventricular valve to prevent and / or inhibit blood from leaking through the native valve leaflets, commissures, and / or around the outside of the prosthetic valve by preventing blood in the atrium from flowing in a direction from the atrium to the ventricle other than through the prosthetic valve. As in the example shown in FIG. 12B, the covering 100 can comprise a braided structure over the docking device 70. The braided structure can be stretched inside the sleeve or covering before deployment of the docking device 70, but after deployment, the braided structure can be allowed to expand to its maximum possible diameter to create a seal. In some embodiments, the braided structure is a braided shape memory material (e.g., shape memory alloy, shape memory metal, nitinol, etc.) that has a set shape and / or is pre-configured to expand to a particular shape and / or size when unconstrained and deployed in the native valve. In some embodiments, the covering 100 is attached to the atrial turn and extends toward the functional turn in a central region and / or extends over a portion of the functional turn. In some embodiments, the covering 100 is attached to the functional turn and extends toward the atrial turn. In further embodiments, the covering 100 can be attached to the docking device core at both ends of the covering 100 and have a free-floating portion therebetween. The covering 100 can also comprise and / or consist of an expandable foam. In some embodiments, the covering portion comprises and / or consists of expandable foam that is memory foam so that it expands to a specific shape or a specific preset shape upon removal of the contracting pressure prior to delivery of the docking device 70, as in the example in FIG. 12A.

[0196] 12F and 12G illustrate different arrangements of various components that may be integrated onto or around the stabilization coil 86 of many embodiments. Specifically, FIG. 12F illustrates a cross-section of the stabilization coil 86 with the covering 100 and second covering 102. As shown, as covering 100 and second covering 102 expand, a cavity 104 forms between the stabilization coil 86 and coverings 100, 102. Also illustrated is the structure of the atrial winding, which includes a core 106, which may be, for example, a NiTi core or a core made from or including one or more of a variety of other biocompatible materials. FIG. 12F also illustrates a tubular layer 108 to provide a cushioning padding layer so that the atrial winding is atraumatic to native tissue. In certain embodiments, the tubular layer 108 is constructed from ePTFE. FIG. 12F further illustrates a braided layer 110 disposed over tubular layer 108. As previously described, braided layer 110 is designed to interact with covering 100 to limit movement and / or trauma to native tissue. It should be noted that FIG. 12F illustrates various options available in the construction of the docking devices of various embodiments, and the specific arrangements are merely illustrative of some embodiments. Accordingly, some embodiments may not necessarily possess all of the components shown in FIG. 12F when constructing the docking device.

[0197] In some embodiments, the cross-section of FIG. 12F may be implemented in the coil shown in FIGS. 12B-12D. Additionally, in some embodiments, the stabilization coil 86 may have two sections, a first section having the cross-section shown in FIG. 12F and an adjacent second section having the cross-section shown in FIG. 12G. The cross-section shown in FIG. 12G may be the same as the cross-section shown in FIG. 12F except that it does not include the braided layer 110. In some embodiments, as shown in FIG. 12E, the region of the covering 100 may be divided into two sections (as indicated by the dotted line), including a first section extending in the direction of arrow 12F and a second section extending in the opposite direction as indicated by arrow 12G. The first section may have the cross-section shown in FIG. 12F, while the second section may have the cross-section shown in FIG. 12G. In certain embodiments, the first section having the cross-section shown in FIG. 12F may have an overall cross-sectional diameter that is smaller than the overall cross-sectional diameter of the second section having the cross-section shown in FIG. 12G. One potential advantage of these embodiments is that the potential for LVOT obstruction is reduced due to the reduced cross-sectional diameter of the portion of the covering 100, 102 that resides in the left ventricle below the anterior leaflet.

[0198] FIG. 12H shows a circumferential extent 130 around the mitral valve annulus, generally illustrating an example extent of the covering portion 100 that may be included in certain embodiments of the docking device 70. FIG. 12H is a plan view of the mitral valve with the posterior portion facing down and the anterior portion facing up. In a healthy heart, the annulus of the mitral valve MV creates an anatomical shape and tension such that, at maximum contraction or systolic pressure, the posterior leaflet PL and the anterior leaflet AL coapt at the flow orifice, forming a tight coaptation, as seen in FIG. 12H. The annulus of the mitral valve MV has a posterior surface to which the posterior leaflet PL attaches and an anterior surface to which the anterior leaflet AL attaches. Where the leaflets meet midway, the lateral sides of the annulus are called leaflet commissures, i.e., the anterior commissure AC and the posteromedial commissure PC. The posterior leaflet is divided into three scallops or cusps, sometimes identified as P1, P2, and P3, starting from the anterior commissure and continuing counterclockwise to the posterior commissure. The posterior scallops P1, P2, and P3 encircle a specific arc around the periphery of the posterior surface of the annulus, which may vary depending on various factors, including the actual measurement of the posterior mitral valve leaflet scallops and surgeon preference. However, as a general rule, the long axis 122 of the mitral annulus intersects both the first and third posterior scallops P1 and P3, approximately at the commissures AC and PC, and the short axis 124 intersects and roughly bisects the middle posterior scallop P2. The anterior leaflet is also characterized by scallops or regions labeled A1, A2, and A3, as indicated in Figure 12H. The anterior leaflet AL of the mitral valve is attached to the fibrous portion FA of the annulus, which makes up approximately one-third of the total annular circumference. The muscular portion of the annulus constitutes the remainder of the annulus, to which the posterior leaflet PL is attached. The anterior fibrous annulus (FA), whose two ends are called the fibrous trigone (T), forms part of the central fibrous body of the heart. The anterior commissure (AC) and posterior commissure (PC) are located immediately posterior to each fibrous trigone. The fibrous mitral annulus (FA) is aligned with or adjacent to the aortic valve (AV), specifically the left coronary sinus (LCS) and the noncoronary sinus (NCS). The central fibrous body is fairly resistant to stretch; therefore, most of the expansion of the mitral annulus occurs in the posterior two-thirds of the annulus or around the muscular mitral annulus.Covering portion 100, with or without additional covering portions 102, can be provided on docking device 70 with a desired length at implantation having a circumferential extent 130. In some embodiments, covering portion 100 can extend from a first radial angular position 134 in the left ventricle, through the PC into the left atrium, and to a second radial angular position 136 in the left atrium. In FIG. 12H, first radial angular position 134 is shown at a point between the PC and the AC, but in other implementations, circumferential extent 130 can extend further around the annulus, toward or beyond the AC, or can extend less than a radial angle around the annulus, as shown as exemplary angular position 138 in FIG. 12H.

[0199] The first radial angular position 134, upon implantation, can be at one of a variety of locations relative to the mitral valve annulus anatomy in various embodiments. In some embodiments, the first radial angular position 134 can be at a radial angular position corresponding to a point at A1, a point at A2, or a point at A3. In certain embodiments, upon implantation, the first radial angular position 134 is below the A2 region of the AL, which can provide the advantage of reducing the risk of LVOT obstruction. In some embodiments, the first radial angular position 134 is selected to avoid overlap with adjacent aortic valve structures in the left coronary sinus LCS and non-coronary sinus NCS. In other embodiments, the first radial angular position 134 may be at a point representing a percentage of the circumferential distance from PC to AC (counterclockwise in FIG. 12H) of about 10%, about 20%, about 30%, about 40%, about 50% (approximately halfway through A2 at the point intersected by the minor axis 124), about 60%, about 70%, about 80%, about 90%, or about 100% (approximately AC).

[0200] The second radial angular position 136 can be at one of a variety of locations relative to the anatomy of the mitral valve annulus in various embodiments upon implantation. In some embodiments, the second radial angular position 136 can be at a radial angular position 132 at or near the AC. In other embodiments, the second radial angular position 136 can be at a point at P1, a point at P2, or a point at P3. In still other embodiments, the second radial angular position 136 can be at a point representing about 10%, about 20%, about 30%, about 40%, about 50% (approximately halfway between P2 at the point intersected by the minor axis 124), about 60%, about 70%, about 80%, about 90%, or about 100% (approximately the AC) of the circumferential distance from the PC to the AC (in a clockwise direction as shown in FIG. 12H ). In a further embodiment, the covering portion 100 can extend all the way up to the radial angular position 132 of the AC onto the portion of the extension portion 140 of the docking device 70 that extends into the left atrium.

[0201] 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 extent 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 a portion of the covering 100 in the left ventricle extends counterclockwise beyond the second radial angular position 136, as seen in FIG. 12H , such that the covering 100 is implanted with an overall radial angular length longer than one complete circumference of the MV.

[0202] In some embodiments, a sleeve or sheath is provided to prevent the covering 100 from expanding until the docking device 70 is deployed. This additional sleeve or sheath can be incorporated into the delivery system and / or delivery device (e.g., such as those described below with reference to FIGS. 17A-20D, 22A-22C, 24A-24B, and 33-34). In some embodiments, the sleeve or sheath can be a biodegradable or bioabsorbable material so that it degrades over a period of time after deployment without additional requirements in the manufacture of the delivery device or in the user's retraction of the sleeve or sheath. In these cases, the sleeve or sheath can be rather a coating on the covering. In embodiments using a bioabsorbable sleeve, the material can be designed to biodegrade over a period of time sufficient to allow deployment and / or redeployment of the docking device 70 and / or prosthetic valve without interfering with the physician, surgeon, or other medical personnel's efforts to deploy the docking device 70 or prosthetic valve.

[0203] In some embodiments of docking devices with a covering 100, such as those shown in FIGS. 12A-12G, the covering can be made of a material selected from the group consisting of braided NiTi, braided NiTi covered with braided PET, braided NiTi covered with woven PET, braided NiTi covered with braided PET, braided NiTi covered with ePTFE membrane, braided NiTi covered with electrospun ePTFE, braided NiTi soaked with elastomer, braided NiTi sprayed with elastomer, braided NiTi between heat compressed layers of thermoplastic membrane, foam, The covering 100 may be made from PET braid, PET woven cloth, PET knitted cloth, a composite braided material with NiTi and PET yarns, a composite braided material with NiTi and PET yarns covered with one or more of braided PET, woven PET, braided PET, ePTFE membrane, electrospun ePTFE, a composite braided material with NiTi and PET yarns dipped or sprayed with elastomer, a composite braided material with NiTi and PET yarns between heat-compressed layers of thermoplastic membrane, or a combination thereof. In certain embodiments, the composite braided material may comprise a braided composite having 48 yarn ends, 30 of which comprise PET and 18 of which comprise NiTi. In further embodiments, the covering 100 may be impregnated with growth factors to stimulate or promote tissue ingrowth, such as transforming growth factor alpha (TGF-α), transforming growth factor beta (TGF-β), basic fibroblast growth factor (bFGF), vascular endothelial growth factor (VEGF), and combinations thereof.

[0204] Various docking devices herein may include a woven or braided texture or coating on various surfaces of the docking device. For example, a docking device with a woven or braided texture or coating on the central region or functional coil can beneficially help increase friction between the docking device, the native anatomy, and / or the prosthetic heart valve when the prosthetic heart valve is deployed in the docking device, which can help improve retention. This can also provide greater surface area for tissue ingrowth. While these textures provide benefits such as better retention for the prosthetic valve, the textures can also cause undesirable friction in the native anatomy while the docking device is positioned on the native valve, which can slow deployment of the docking device and / or cause damage to the native anatomy. In some embodiments, the woven or braided texture or coating is part of and / or is firmly attached to the outer wall of the docking device to maintain a low profile and to secure the location. In some embodiments, the woven or braided texture or coating comprises an ePTFE coating and / or a PET coating.

[0205] 13A-13C show schematic cross-sectional views of a portion of an example docking device configured to improve retention between the docking device and a replacement valve. FIG. 13A shows a portion of three turns (e.g., central region 80) of docking device 70, while FIG. 13B shows a cross-sectional view of docking device 70. Docking device 70 includes a main coil or core 1102, which may be, for example, a NiTi coil / core or a coil / core made from or including one or more of a variety of other biocompatible materials. Docking device 70 further includes a covering 1104 covering coil / core 1102. The covering 1104 may be made from or include a high-friction material so that when the expandable valve is expanded in the docking device 70, an increased degree of friction is generated between the valve and the covering 1104 to retain the shape of the docking device 70 and to prevent or inhibit / resist unraveling of the docking device 70. In some embodiments, the covering also or alternatively increases the degree of friction between the docking device and the native valve leaflets and / or prosthetic valve to help maintain the relative positions of the docking device, leaflets, and / or prosthetic valve. In some embodiments, the covering 1104 is made from one or more high-friction materials disposed over the coil wire / core 1102. In some embodiments, the covering 1104 is made from or includes a PET braid.

[0206] In additional embodiments, covering portion 1104 is made of or includes a PET braid over an ePTFE tube (e.g., 1106 in FIG. 13C ), which serves as a core for covering portion 1104. The ePTFE tube is porous and provides a padded layer to cushion the struts or other portions of the expandable valve frame for implantation, improving engagement between the valve and docking device 70. Meanwhile, the PET layer provides additional friction against the leaflets of the native valve when the prosthetic valve is expanded 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 valve leaflets and / or prosthetic valve, thereby also increasing retention force and preventing the docking device 70 from unraveling.

[0207] In other embodiments, the covering 1104 may be made from one or other high-friction materials that coat the coil 1102 in a similar manner. The material selected to make the covering 1104 may also promote rapid tissue ingrowth. Also, in some embodiments, the outer surface of the replacement valve frame may be coated with a fabric or other high-friction material to further increase the friction between the docking device and the valve, thereby further reducing or preventing the docking device from unraveling. The friction provided by the covering may provide a coefficient of friction greater than 1. The covering may be made from ePTFE, which may be a tube covering the coil, and may be smooth or have holes to promote tissue ingrowth (or may be braided or have other structural features that provide a larger accessible surface area, as holes do). The covering may have a PET braid over the ePTFE tube when the ePTFE tube is smooth. The outermost surface of the covering or the braid over the covering may be any biocompatible material that provides friction, such as a biocompatible metal, silicone tubing, or PET. The pore size in the sheath can range from 30 to 100 microns. In embodiments with a PET sheath over ePTFE, the PET layer can only be attached to the ePTFE sheath and not directly to the docking device coil. The ePTFE sheath can be attached to the docking device coil at the proximal and distal ends of the sheath. The ePTFE sheath can be laser welded to the coil or crimped to the coil to hold it in place, including using radiopaque markers placed on the outside of the ePTFE sheath or PET braid as crimping material.

[0208] The covering portion 1104 can be added to any of the docking devices described herein and can cover all or a portion of the docking device. For example, the covering portion can be configured to only cover the functional coil, the leading coil, the stabilization coil, or only a portion of one or more of these (e.g., only a portion of the functional coil).

[0209] 14A-14C illustrate embodiments utilizing a smooth and / or soft covering 1200 over a core 1202 of a docking device to reduce friction while maintaining retention for the prosthetic valve. In a specific embodiment, the soft covering 1200 is expanded polytetrafluoroethylene (ePTFE), although other materials are possible. In FIG. 14A, the core 1202 is surrounded by two layers, which may be two layers of ePTFE. The outer layer 1204 may be low-density ePTFE, which allows the prosthetic valve to be embedded in the ePTFE, thus providing retention for the prosthetic valve. Additionally, the inner layer 1206 may be a higher-density ePTFE that prevents tearing or shifting of the ePTFE at the distal and proximal ends of the docking device during deployment (e.g., items 21 and 31, FIGS. 9A-11C). An exemplary low-density ePTFE has a density of approximately 0.2 g / cm. 3 An exemplary higher density ePTFE may be approximately 1.3 g / cm 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 1.9 g / cm 3 The outer diameter of the inner layer 1206 may be approximately 1.34 mm (e.g., ±1 mm). The outer diameter of the outer layer 1204 may be 3.1 mm (e.g., ±1 mm). In certain embodiments, the outer diameter of the outer layer 1204 may be 3.1 mm or less.

[0210] In some embodiments, the soft and / or smooth covering utilizes a three-layer approach, as shown in Figure 14B. In the three-layer example, a middle layer 1208 of ePTFE is held between the inner layer 1206 and the outer layer 1204. In some embodiments, the middle layer 1208 utilizes ePTFE that is of a higher density than the outer layer 1204 but of a lower density than the inner layer 1206. For example, a three-layer embodiment such as that shown in Figure 14B may utilize a density of about 0.2 g / cm 3 and an outer layer 1204 of ePTFE of about 1.3 g / cm 3 to approximately 1.9 g / cm 3 and an inner layer 1206 of ePTFE having a density between about 0.2 g / cm 3 to approximately 1.9 g / cm 3 and a middle layer 1208 using ePTFE having a density between 0.84 mm and 0.83 mm. In some embodiments using a two-layer soft and / or smooth covering, the core diameter will be approximately 0.84 mm (e.g., ±0.5 mm), although some embodiments have a core diameter of at least 0.83 mm. Also, the outer diameter of the inner layer 1206 in some embodiments will be approximately 1.34 mm (e.g., ±1 mm). Also, the outer diameter of the middle layer 1208 in some embodiments will be approximately 1.62 mm (e.g., ±1 mm), while the outer diameter of the outer layer 1204 in various embodiments will be 3.1 mm (e.g., ±1 mm). In some embodiments, the outer diameter of the outer layer 1204 will be 3.1 mm or less.

[0211] Some embodiments that include multiple layers of ePTFE to create a soft and / or smooth covering have the layers bonded together along the entire length of the covering and / or docking device. However, additional embodiments use intermittent adhesive patterns to increase the adhesiveness of the covering, such as that shown in FIG. 14C , which shows the length of a docking device with a smooth and / or soft covering. Bonds 1210 are shown at various locations along the length of the soft covering 1200. The distance between bonds can be every 5 mm, 8 mm, or 12 mm in various embodiments. In some embodiments, the bonds can be at variable distances to tailor the properties along the length of the docking device.

[0212] The functional coils of the docking devices herein can be similar or the same in size and shape, or they may vary in size and / or shape. Looking at FIGS. 15A-15D, variations to the functional coil of the docking device 70 are shown. In FIGS. 15A and 15B, the central region 80 possesses a generally hourglass shape in the functional coil, such that the functional coil has a larger inner diameter at the inflow and outflow portions 1302, 1304 of the central region 80, with a smaller inner diameter at the middle portion 1306. Conversely, FIGS. 15C and 15D show the central region 80 possessing a generally barrel shape, with a larger inner diameter at the middle portion 1306 and smaller inner diameters at the inflow portion 1302 (e.g., atrium or proximal) and outflow portion 1304 (e.g., ventricle or distal). The hourglass and / or barrel designs of Figures 15A-15D, respectively, can allow for better flushing of the prosthetic valve leaflets, which can help prevent blood clots from forming.

[0213] 15A-15D can be formed in a variety of ways, including forming a docking device 70 with a uniform cross-section from the proximal tip 88 to the distal tip 84, while the shape of the central region 80 maintains the hourglass or barrel shape, respectively, shown in FIGS. 15A-15D. Another method of creating these shapes would be to vary the cross-section from the proximal tip 88 to the distal tip 84, such that the inner diameter in the central region 80 possesses either an hourglass or barrel shape. Also, the number of functional coils can be increased to form the hourglass or barrel shape of FIGS. 15A-15D. For example, some hourglass-shaped embodiments utilize a three-coil central region 80 (as shown in FIG. 15A ), with the most distal and proximal functional coils possessing larger inner diameters while the middle coils possess relatively smaller inner diameters; other embodiments utilize a five-coil central region 80 (as shown in FIG. 15B ); and other embodiments use seven or more coils in the central region 80, with a more gradual change in inner diameter between the larger diameters of the most distal and proximal functional coils and the middle coils. Conversely, barrel-shaped embodiments utilize a similar number of coils as described for the hourglass shape, including a three-coil configuration ( FIG. 15C ), a five-coil configuration ( FIG. 15D ), or seven or more coils, although it should be noted that the barrel shape results in an increased inner diameter for the middle coil relative to the most distal and proximal functional coils. Furthermore, these examples of three, five, and seven coils are merely for illustrative purposes and should not be construed as limiting the number of coils to an odd number of coils or as limiting the number of coils to only these examples.

[0214] In some embodiments, the docking devices herein can further incorporate a flange 1402 on the stabilizing coil of the docking device 70, as shown, for example, in Figure 16. In Figure 16, the stabilizing coil 86 carries a cloth or other fabric connected to the next adjacent turn 1404 in the central region 80. The fabric acts as a flange 1402 to reduce paravalvular leakage and / or increase the amount of blood flowing through the prosthetic valve.

[0215] In some embodiments, various docking devices herein include one or more radiopaque markers along the length of the docking device. For example, a radiopaque marker can be placed at the distal tip of some embodiments, and some embodiments include a radiopaque marker approximately one-quarter of the way through the coil of the docking device. Additional embodiments include multiple radiopaque markers positioned throughout the docking device. For example, radiopaque markers can be placed every 25 mm, 29 mm, 30 mm, 34 mm, or greater intervals and can be used by medical professionals to identify the amount of expansion in the diameter of the functional turns, such as when a prosthetic valve is later deployed in the docking device. Radiopaque marker bands can be laser welded to the coil, or placed on the outside of the ePTFE tubing or PET braid and crimped to the material to hold them in place on the coil.

[0216] It should be noted that various embodiments incorporate multiple features, such as those described in connection with Figures 12A-16, and that where certain techniques are not mutually exclusive and / or physically incombinable (e.g., the docking device possessing both the hourglass and barrel shapes of Figures 15A-15D), all combinations of these features are contemplated herein. It should also be noted that while the terms stabilization coil / turn and atrial coil / turn are used concurrently or interchangeably herein, docking devices can be used in other locations where a similar shape is beneficial, and the use of these terms is not meant to limit the use of the embodiments described herein to deployment in the atrium.

[0217] Delivery System Certain embodiments are directed to delivery systems and / or devices for delivering an anchor / docking device (such as one of the docking devices previously described in connection with FIGS. 9A-16 ) to the heart and / or native valve of an animal, human, cadaver, cadaver heart, anthropomorphic skeleton, and / or simulation / simulator. Such devices include a transcatheter device that can be used to guide the delivery of the docking device through the vascular system.

[0218] A delivery system 2220 configured to deliver a docking device 2232 to a target implantation site is shown in FIG. 24B. In some embodiments, the docking device 2232 can be one of the docking devices described above with reference to FIGS. 9A-16. The delivery system can include a handle assembly 2200 and an outer shaft (e.g., a delivery catheter) 2260 extending distally from the handle assembly 2200. The handle assembly 2200 can include a handle 2222 including one or more knobs, buttons, wheels, or the like. For example, in some embodiments as shown in FIG. 24B, the handle 2222 can include knobs 2224 and 2226 that can be configured to control bending of the delivery system (e.g., outer shaft 2260). Further details on delivery systems, such as delivery system 2220, configured to deliver a docking device to a target implantation site can be found in U.S. Patent Application Publication Nos. 2018 / 0318079, 2018 / 0263764, and 2018 / 0177594, which are incorporated by reference herein in their entireties.

[0219] During delivery of some docking devices at the target implantation site, the docking device risks becoming caught, jammed, and / or obstructed by native portions of the anatomy, such as the heart wall, trabeculae, native valve leaflets, and chordae tendineae, due to several factors, such as frictional forces against the native anatomy, the distal end or tip getting caught on the trabeculae and / or chordae, and the size difference between the inner diameter of the functional turns of the docking device and the outer diameter of the native valve leaflets. Some docking devices have a woven or braided texture and / or coating on the surface of the docking device to increase friction. This friction can make it difficult to advance the docking device around the native anatomy. Furthermore, while the native valve leaflets can have a diameter of up to approximately 55 mm, the functional turns of the docking device are generally designed to be significantly smaller (e.g., as small as approximately 22 mm). When the functional turn of the docking device is smaller, the native leaflets push into the docking device, increasing the frictional force between the native leaflets and the docking device.

[0220] If the docking device navigates into such an obstacle, the doctor, surgeon, or other medical personnel may need to retract the docking device into the delivery system (e.g., the transcatheter device) and attempt to deploy the docking device again. This trial and error methodology can damage the native tissue as the texture or braid present on the docking device rubs against and / or catches on a portion of tissue, pulling the docking device back into the transcatheter delivery system, which can damage or clog the transcatheter delivery system. Furthermore, this can extend the length of time for the deployment procedure.

[0221] To overcome these difficulties, it is desirable to provide a docking device that has a smooth outer surface (e.g., on the functional turns and / or elsewhere), but has higher friction functional coils / turns once properly positioned and during subsequent deployment of the prosthetic valve in that position. In some embodiments, this can be achieved with a temporary smooth sleeve or sheath that can be placed over the docking device during delivery, and that can be retracted from the docking device after the docking device is in the desired position / location. In some embodiments, smooth or low-friction sleeves / sheaths can be incorporated into transvascular and transcatheter delivery systems, such as delivery system 2220 of FIG. 24B.

[0222] Embodiments of delivery systems that include a smooth sleeve, such as delivery system 2220, have the following characteristics: a durable, smooth, kink-resistant sleeve that can withstand numerous repositioning cycles (e.g., more than 30 cycles); a sleeve that can be advanced into the anatomy simultaneously with the docking device but move independently from the docking system and the pusher shaft of the delivery system; a sleeve that increases the ease with which the docking device is encircled, reducing the risk of damage to the mitral valve anatomy; and a sleeve that can be retracted prior to releasing the docking device without affecting the position of the docking device. The following features may be included: 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 or retrieval forces of the docking device; a sleeve that is ergonomic and does not significantly increase the number of procedural steps or include simultaneous steps; a sleeve that allows for inner and outer lumens of the sleeve so that the delivery system has continuous irrigation to avoid thrombus formation; a sleeve that has radial strength to compress a paravalvular leak solution at the dock (e.g., foam or braid as discussed above) before retracting the sleeve. To provide a retractable sleeve for covering the docking device, certain embodiments provide two shafts for delivery of the docking device that can be actuated independently of each other: a pusher shaft for pushing the docking device into position and a sleeve shaft for actuating a smooth sleeve that surrounds the docking device with minimal increase in the outer diameter of the delivery system. In many embodiments, the two shafts run coaxially inside the delivery catheter.

[0223] For example, in some embodiments, the delivery system 2220 may include a pusher shaft 2238 and a sleeve shaft (not visible in FIG. 24B ) coaxially positioned within the outer shaft 2260, each having a portion that extends into the handle assembly 2200. The pusher shaft 2238 may be configured to deploy the docking device 2232 from inside the distal end portion of the outer shaft 2260 upon reaching the target implantation site, and the sleeve shaft may be configured to cover the docking device while inside the delivery system 2220 and while implanted at the target implantation site. Additionally, the delivery system 2220 may be configured to adjust an axial portion of the sleeve shaft to remove the sleeve portion (e.g., distal section) of the sleeve shaft from the docking device 2232 after implantation at the target implantation site, as described further below. As shown in FIG. 24B, during delivery, the docking device 2232 may be coupled to the delivery system via a release suture 2236 (or other retrieval line comprising a string, thread, or other material that may be configured to be tied around the docking device and cut for removal) that extends through the pusher shaft 2238. As further described below with reference to FIGS. 24A and 27A-30C, the release suture 2236 may extend through the delivery system 2220, through the internal lumen of the pusher shaft 2238, and to the suture lock assembly 2206 of the delivery system 2220. Further details regarding the pusher shaft and sleeve shaft are discussed below with reference to FIGS. 24A, 17A-23B, and 33-34.

[0224] The handle assembly 2200 may further include a hub assembly 2230 with a suture lock assembly (e.g., suture lock) 2206 and a sleeve handle 2234 attached thereto. The hub assembly may be configured to control the pusher shaft and sleeve shaft of the delivery system 2220, while the sleeve handle 2234 can control the position of the sleeve shaft relative to the pusher shaft. In this manner, operation of the various components of the handle assembly 2200 can actuate and control operation of components disposed within the outer shaft 2260. In some embodiments, the hub assembly 2230 may be coupled to the handle 2222 via a connector 2240.

[0225] The handle assembly 2200 may further include one or more irrigation ports to supply irrigation 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 clot formation. One embodiment in which the delivery system 2220 includes three irrigation ports (e.g., irrigation ports 2210, 2216, and 2218) is shown in FIG. 24B. Further details regarding these irrigation ports and components of the handle assembly 2200 are discussed below with reference to FIG. 24A.

[0226] Sleeve shaft An example sleeve shaft 1500 according to various embodiments that may be implemented into a docking device delivery system, such as delivery system 2220 of FIG. 24B, is shown in FIGS. 17A-20D. Other variations of the sleeve shaft are possible with only some of the illustrated features in these figures and / or with additional, unillustrated features. In some embodiments, as shown in FIG. 17A, the sleeve shaft 1500 comprises three sections: a distal or sleeve section 1502 comprising a smooth sleeve to cover the docking device during deployment; a proximal section 1504 used to manipulate or actuate the sleeve position; and an intermediate section 1506 for connecting the distal and proximal sections 1502 and 1504. A portion of the proximal section 1504 may be disposed in a handle assembly (discussed further below with reference to FIGS. 24A and 35-37). Additionally, sections 1502, 1504, and 1506 of sleeve shaft 1500 may be formed from multiple components and / or materials, including a flexible polymer jacket 1516 (FIG. 17D), a more rigid tube 1530 (FIG. 17E), an inner liner 1540 (FIGS. 17B, 17C, 19, and 20C), and a metal braid 1542 (which may be part of or embedded within a portion of polymer jacket 1516). For example, as described further below, the polymer jacket 1516 can be part of the distal section 1502 and the intermediate section 1506, the inner liner 1540 can extend along and form the inner surfaces of the distal section 1502 and the intermediate section 1506, and the tube 1530 can form the proximal section 1504, with a portion extending into the proximal portion of the intermediate section 1506. In this manner, each of the distal section 1502, proximal section 1504, and intermediate section 1506 of the sleeve shaft 1500 can include different material layers and compositions, as described further below.

[0227] Because the distal section 1502 is configured to cover the docking device, the distal section of various embodiments can be flexible, have a lower durometer (e.g., hardness), and have a hydrophilic coating. The hydrophilic coating of some embodiments acts as a smooth surface, improving ease of encircling the native anatomy, reducing the risk of damage to the native anatomy and shortening the procedure time. A smooth sleeve can cover higher friction areas of the docking device during implantation. The distal section 1502 can also act as a covering for a foam or braided paravalvular leak solution that may be present in the docking device, as discussed above. Because the distal section 1502 acts as a sleeve or cover for the docking device, in many embodiments it can form a tubular structure (e.g., as shown in FIG. 17D , as discussed further below). This tubular structure has an inner diameter sufficient to encircle the docking device and an outer diameter that is not much larger than the diameter of the docking device. For example, in some embodiments, the inner diameter of the distal section 1502 of the sleeve shaft 1500 is approximately 2.4 mm (e.g., ±0.3 mm) and 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 and the outer diameter is 3.4 mm ±0.2 mm. Furthermore, in some embodiments, the length of the distal section 1502 is sufficient to cover the entire length of the docking device from the distal end to the proximal end. In some embodiments, the distal section 1502 is longer than the docking device to allow some slack to cover the coupling region of the docking device or to provide extra space for additional flexibility or any other reasonable purpose.For example, in some embodiments, during delivery, the distal tip (or end) 1512 of the distal section 1502 can extend beyond the distal end of the docking device (labeled 1514 in FIG. 17B , although in alternative embodiments, the location 1514 of the distal end of the docking device can be spaced further from the distal tip 1512), thereby providing the distal section 1502 of the sleeve shaft 1500 with a more atraumatic tip that can bend, crush, deform, etc. as it is navigated around the native anatomy of the docking device implantation site. This is further described below with reference to FIG. 33 . In some embodiments, the distal section 1502 is approximately 400 mm in length (e.g., ±10 mm). In some embodiments, the length of the distal section 1502 can be in the range of 385 mm to 415 mm.

[0228] As shown in FIG. 18 , in some embodiments, the distal section 1502 comprises multiple distinct components. In some embodiments, the distal section 1502 is constructed from a flexible polymer 1602 over a supporting braid 1604. The flexible polymer 1602 (which may be part of the polymer jacket 1516) can be selected from a variety of elastomeric materials, but the braid should be supportive and flexible, including a high-density braid (measured by picks per inch, e.g., 80 ppi, 90 ppi, etc.). In some embodiments, the braid 1604 can be constructed from a metal such as nitinol or stainless steel. In some embodiments, the braid 1604 can be a stainless steel braid having a density of approximately 90 ppi. In certain embodiments, the flexible polymer can be a polyetheramide block copolymer or a blend of two or more polyetheramide block copolymers. The flexible polymer may have a Shore D hardness, measured according to ISO 868:2003, of 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, of 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, between about 10 MPa and about 11 MPa, about 12 MPa, about 13 MPa, about 14 MPa, or about 15 MPa. In certain embodiments, the flexible polymer can be one or a mixture of two or more of PEBAX® grades 2533, 3533, 4033, 4533, and 5513 (Arkema SA, France) and VESTAMID® grade E40 (Evonik Industries AG, Germany). In some embodiments, the flexible polymer can be PEBAX® 2533.

[0229] Additional embodiments of the distal section 1502 may include an inner layer (e.g., inner liner) 1606 to provide the docking device with an inner layer (which may be part of the inner liner 1540), which may be made from various polymeric materials such as PTFE. Finally, in some embodiments, if the flexible polymer 1602 is not sufficiently lubricious, a hydrophilic coating 1608, such as a hydrogel, is applied to the outside of the sleeve. The hydrophilic coating may provide various benefits, such as allowing the sleeved docking device to be more easily guided around the anatomy of the native valve without significant friction. The hydrophilic compound may also increase echogenicity, thereby enabling visualization of the sleeve using ultrasound. Furthermore, the distal section 1502 of some embodiments may include a radiopaque material to enhance the ability to visualize the sleeve during deployment of the docking device, as further described below with reference to FIG. 19.

[0230] 18 shows an exemplary configuration of the distal section 1502, other embodiments can utilize cut (such as laser cut) higher durometer material. In such laser cut higher durometer material embodiments, the cuts can make the distal section 1502 more flexible and allow the distal section 1502 to bend, while the higher durometer material can provide integrity to the distal section.

[0231] The distal section 1502 of the sleeve shaft 1500 of various embodiments also includes a distal tip 1520, as shown in FIG. 17B and in more detail in FIG. 19. The distal tip 1520 can incorporate a thinner and / or softer material to help the sleeve deflect if the distal tip contacts an obstacle. In some embodiments, the distal tip 1520 is also tapered to have a smaller diameter at its distal end 1512. As shown in FIG. 19, in some embodiments, the inner liner 1540 may not extend to the distal end 1512, thereby causing the distal end portion of the distal tip 1520 to consist solely of a flexible polymer (e.g., the flexible polymer material of the polymer jacket 1516). Additionally, some embodiments incorporate a radiopaque material into the distal tip 1520 of the sleeve shaft 1500 to increase its visibility (e.g., at the target implantation site) during deployment from a delivery system. In some embodiments, the radiopaque material can be in the form of one or more marker bands 1552 embedded within the polymer jacket 1516 and spaced from the distal end 1512, as shown in FIG. 19 . In some embodiments, the metal braid or braided portion of the polymer jacket 1516 can terminate a distance before the distal end of the marker bands 1552, such as at location 1554 shown in FIG. 19 . In some embodiments, the radiopaque material of the marker bands 1552 is a platinum-iridium marker, while other embodiments utilize a section of flexible polymer loaded with bismuth or BaSO4, 60% BaSO4.

[0232] The intermediate section 1506 of the sleeve shaft 1500 of various embodiments serves to provide column strength for docking and retracting the distal section 1502 after the docking device surrounds the native valve anatomy and guides the patient's anatomy from the point of delivery system insertion into the heart. Therefore, the intermediate section 1506 of various embodiments can be flexible and possess a braided polymer shaft. Also, in some embodiments, the intermediate section 1506 can include a flexible polymer of varying durometer along its length, as further described below with reference to FIG. 17D . The intermediate section 1506 of many embodiments can be constructed from a flexible polymer over a supporting braid. In certain embodiments, the flexible polymer can be a polyetheramide block copolymer or a blend of two or more polyetheramide block copolymers. The flexible polymer may 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 about 60, or about 55. In some embodiments, the flexible polymer may 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 may be one or a mixture of two or more of PEBAX® grades 4033, 4533, 5533, 6333, and 7033 (Arkema SA, France) and VESTAMID® grades E40, E47, E55, E58, and E62 (Evonik Industries AG, Germany). In some embodiments, the flexible polymer may be PEBAX® 5533. In other embodiments, the flexible polymer may be VESTAMID® E55. The braid may be of the same density as the distal section 1502 (e.g., 80 ppi, 90 ppi, etc.) or of a lower density than the distal section 1502 (e.g., 60 ppi).Also, in some embodiments, the intermediate section 1506 is a tubular structure adapted and / or configured to allow the sleeve shaft to move over the pusher shaft. As a tubular structure, the inner diameter can be approximately 2.25 mm (e.g., ±0.3 mm) while the outer diameter can be approximately 3.0 mm (e.g., ±0.5 mm). In some embodiments, the inner diameter is 2.21 mm and the outer diameter is 3.07 mm. In various embodiments, the length of the intermediate section is sufficient to navigate through the patient's anatomy. In many embodiments, the length of the intermediate section is approximately 940 mm (e.g., ±50 mm).

[0233] In some embodiments, the distal section 1502 and the intermediate section 1506 are formed as a single, continuous unit with varying properties (e.g., dimensions, polymer, braid, etc.) along the length of the single unit. For example, FIG. 17D shows an exemplary embodiment of a flexible polymer jacket (or covering) 1516 and its associated location in the above sections of the sleeve shaft 1500. The polymer jacket 1516 may be included in and / or at least partially form the distal section 1502 and the intermediate section 1506 of the sleeve shaft 1500. The dashed line in FIG. 17D indicates the proximal section 1504 of the sleeve shaft 1500, which does not include a flexible polymer jacket. In some embodiments, as previously described, the polymer jacket 1516 may comprise different grades or hardnesses of the same flexible polymer (e.g., PEBAX®) along its length. Alternatively, the polymer jacket 1516 may have a varying (eg, increasing) hardness (which may also be referred to as durometer) along its length from its distal end 1518 to its proximal end 1522.

[0234] By way of example, the distal section 1502 may comprise a flexible polymer (e.g., PEBAX®) with a first hardness (e.g., Shore D). Possible grades and Shore D hardnesses for the distal section 1502 are discussed above. The portion of the polymer jacket 1516 forming the intermediate section 1506 may comprise a first section 1524 comprising the same flexible polymer with a second hardness that is greater (e.g., less flexible) than the first hardness of the distal section 1502, and a second section 1526 including the same flexible polymer with a third hardness that is greater (e.g., less flexible) than the second hardness. Possible grades and Shore D hardnesses for the intermediate section 1506 are discussed above. In some embodiments, the first hardness can be about 20 to about 24, the second hardness can be about 50 to about 60, and the third hardness can be about 55 to about 65. The polymer jacket 1516 may thereby have increasing hardness and decreasing flexibility toward its proximal end 1522. In alternative embodiments, the polymer jacket 1516 may include more zones with varying hardness than those shown in FIG. 17D. For example, in some embodiments, the portion of the polymer jacket 1516 forming the intermediate zone 1506 may include three or more zones with different hardnesses (e.g., three zones, each having a different hardness).

[0235] In some embodiments, the inner liner 1540 can be disposed along the inner surface of the polymer jacket 1516 in the distal section 1502 and the intermediate section 1506. As previously described, in some embodiments, the inner liner 1540 can comprise a thin layer of a polymer, such as PTFE. The polymer material of the inner layer 1540 and the polymer material of the polymer jacket 1516 can be configured to adhere to one another.

[0236] The proximal section 1504 of the sleeve shaft is designed to be more rigid and provide column strength to actuate smooth sleeve positioning by pushing the intermediate section 1506 and the distal section 1502 with a docking device (e.g., docking device 70 as shown in FIGS. 9A-11C) and retracting the distal section 1502 after the docking device has encircled the native anatomy. Because the sleeve shaft 1500 of various embodiments operates to encircle a pusher shaft (e.g., pusher shaft 1900 of FIGS. 21A-21G, as described further below), the structure may be shaped and configured to be generally tubular and more rigid. For example, the proximal section 1504 may be formed by a relatively rigid tube 1530, as shown in FIG. 17E. In some embodiments, the tube 1530 may be constructed from a surgical-grade metal, such as stainless steel. In some embodiments, the tube 1530 may be a hypotube.

[0237] The tube 1530 may include a first section 1532 (which may form the entire proximal section 1504) and a second section 1534 that extends into the intermediate section 1506 (see FIGS. 17E and 20B ). As described further below, the first section 1532 includes a cut portion 1508 having a cross-section (a cross-section in a plane perpendicular to the central longitudinal axis 1501 of the sleeve shaft 1500) that is not a perfect circle (e.g., is open and does not form a closed tube). The remainder of the tube 1530 may be tubular (e.g., a closed tube having a relatively circular cross-section). As described further below, the second section 1534 may 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.

[0238] As a tubular structure, the tube 1530 of various embodiments can have an inner diameter of approximately 2.4 mm (e.g., ±0.3 mm), while the outer diameter can be approximately 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).

[0239] As introduced above, the first section 1532 of the tube 1530 may include a cutting portion 1508 adjacent the proximal end 1536. As shown in FIGS. 24A, 35, and 36 (described in further detail below), the cutting portion 1508 of the sleeve shaft 1500 extends into the hub assembly 2230 of the handle assembly 2200, and a portion of the pusher shaft 1900 (e.g., the proximal extension 1910) extends along the inner surface of the cutting portion 1508. The cut (e.g., open) profile of the cutting portion 1508 can allow the proximal extension 1910 of the pusher shaft 1900 to extend out of the open space 1544 ( FIGS. 20A and 20B ) formed in the cutting portion 1508 and to branch off at an angle to the cutting portion 1508 into the bifurcated portion 2204 of the hub assembly (e.g., a suture lock 2206 can be coupled to the end of the bifurcated portion 2204, as shown in FIG. 24A ). This allows the pusher shaft 1900 and sleeve shaft 1500 to operate parallel to one another, and the overall length of a delivery system incorporating the sleeve shaft 1500 and pusher shaft 1900 can be maintained similar to, or minimally longer than, previous delivery systems not incorporating a sleeve.

[0240] In some embodiments, the cut portion 1508 may have a generally U-shaped cross-section with a portion of the complete tubular structure removed. For example, the cut portion 1508 may form an open passageway or conduit. In various embodiments, the cut portion 1508 may be cut using a laser, although any other means for removing a portion of the tubular structure may be used. Example embodiments of the shape of the cut portion 1508 are seen in FIGS. 20A and 20B. However, in alternative embodiments, a different portion of the periphery of the tube 1530 than that shown in FIGS. 20A and 20B may be removed / cut to form the cut portion 1508.

[0241] An end surface 1545 (FIGS. 20A and 20B) is formed in (e.g., exposed on) the complete tubular portion of first section 1532 at the interface between cut portion 1508 and the remainder of first section 1532. This end surface 1545 can be positioned perpendicular to central longitudinal axis 1501 and can be configured for flush contact with a stop element (e.g., plug 1906) of the pusher shaft (e.g., as shown in FIG. 22B and further described below).

[0242] 17E, the second section 1534 of the tube 1530 is configured to allow for bonding of the proximal end of the second portion 1526 of the polymer jacket 1516 and may include a plurality of openings 1546 disposed in 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 an interface between the first section 1532 and the second section 1534 of the tube 1530. However, in FIG. 20C, the inner liner 1540 and the second section 1534 of the tube 1530 are not bonded together. As shown in Figure 20D, the polymer jacket 1516 can be reflow bonded over the exterior surface of the second section 1534 and adhered to the inner liner 1540 through the openings 1546. Thus, in Figure 20D, the second section 1534 of the tube 1530 is sandwiched between the polymer jacket 1516 and the inner liner 1540.

[0243] For example, the polymers of the polymer jacket 1516 and the inner liner 1540 may not be able to bond (e.g., adhere) directly to the material (e.g., metal) of the tube 1530, but may be able to bond to each other. Thus, the size and shape of each opening 1546 and the relative placement of the openings 1546 in the second section 1534 can be selected to firmly bond the outer polymer jacket 1516 to the inner liner 1540, with the second section 1534 of the tube 1530 disposed therebetween. The tube 1530 can thereby be secured to the polymer jacket 1516 and the inner liner 1540.

[0244] 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 (pushed-through holes) that are punched or cut entirely through the second section 1534 of the tube 1530. Thereby, in some embodiments, at the axial location of each one visible aperture 1546 in FIG. 17E, another aperture 1546 can be positioned 180 degrees around the circumference of the tube 1530 from the visible aperture 1546. For example, as shown in FIG. 17E, the second section 1534 can include 28 apertures 1546, with adjacent sets of apertures 1546 offset by 90 degrees from each other. In some embodiments, the openings may be spaced axially from one another along the length of the second section 1534 by a first (center-to-center) distance 1548, and each set of openings 1546 at the same axial location may be spaced apart from an adjacent set of openings 1546 by a second distance 1550. In some embodiments, the first distance 1548 is approximately 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 the first distance 1548. In alternative embodiments, a different number of openings 1546 and / or a different relative spacing and arrangement between the openings 1546 than that shown in FIG. 17E and described above are possible while still providing adequate adhesion between the inner liner 1540 and the polymer jacket 1516.

[0245] In some embodiments, the openings 1546 can be circular with a diameter ranging from 0.5 to 1.5 mm, 0.8 to 1.2 mm, or 0.95 to 1.05 mm. In some embodiments, the diameter of the openings 1546 can be approximately 1.0 mm. In some embodiments, the openings 1546 can have other shapes, such as oval, square, rectangular, star, or triangular. The diameter or width of each opening 1546 can be selected so that the flexible polymer jacket 1516 can be reflowed across the outer surface of the tube 1530, flow into the openings 1546, and firmly bond to the inner liner 1540 disposed on the inner surface of the tube 1530 at the interface between the intermediate section 1506 and the proximal section 1504, as shown in detail view 1510 in FIG. 17C .

[0246] 20A, a gasket 1804 may be positioned 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 pusher shaft (e.g., pusher shaft 1900 as shown in FIGS. 21A-21B and described further below) extending through the sleeve shaft 1500. According to some embodiments, the seal formed by the gasket 1804 is to prevent fluid from flowing back through the delivery system or from finding a less resistant path through another intended lumen, as described further below.

[0247] Push-in shaft An example pusher shaft 1900 that may be used in a delivery system for a docking device, such as delivery system 2220 of FIG. 24B , according to various embodiments, is shown in FIGS. 21A-21G and 23A-23B. FIG. 21A shows the four main components of the pusher shaft 1900, and FIG. 21B shows a more detailed embodiment of the pusher shaft 1900. A side view of an example distal end of the pusher shaft 1900 is shown in FIG. 21C, and a view of the proximal end of the pusher shaft 1900 is shown in FIG. 21D. FIGS. 21E-21G show some of the individual components of the pusher shaft 1900, including a main tube (which in some embodiments may be a hypotube) 1902 (FIG. 21E), an outer shell 1904 (FIG. 21F), and a plug 1906 (FIG. 21G). 23A-23B show views of a portion of the pusher shaft 1900, where the outer shell 1904, main tube 1902, and proximal extension 1910 of the pusher shaft 1900 interface with one another. These views of the pusher shaft 1900 show the central longitudinal axis 1901 of the pusher shaft 1900, which may be coaxial with the central longitudinal axis 1501 of the sleeve shaft 1500 and the outer shaft 2260 of the delivery system, as further described below with reference to FIGS. 22A-22C.

[0248] As shown in FIGS. 21A-21G, the example pusher shaft 1900 comprises four sections or components: a main tube (e.g., shaft) 1902 for advancing and retracting a docking device (such as one of the docking devices described herein) and for accommodating a release suture that secures the docking device to the pusher shaft; an outer shell 1904 that surrounds the pusher shaft 1900, allows engagement with the shaft, and provides a hemostatic seal to the pusher shaft without interfering with movement of the sleeve shaft; a plug 1906 that connects the main tube 1902 to the housing 1904 and acts as a stop for the sleeve shaft; and a proximal extension 1910 (best shown in FIGS. 23A-23B) that routes the pusher shaft from inside to outside the sleeve shaft, allowing the two shafts to operate in parallel and shortening the overall length of the delivery system.

[0249] The main tube 1902 can extend from the distal end of the outer shaft of the delivery system (e.g., outer shaft 2260 shown in FIG. 24B ) to the handle assembly of the delivery system (e.g., handle assembly 2200 of FIGS. 24A and 24B ). For example, as shown in FIGS. 35 and 36 and described further below, the proximal end portion 1912 of the pusher shaft 1900, including the interface between the main tube 1902, the outer shell 1904, the plug 1906, and the proximal extension 1910 (as shown in FIGS. 21A , 21B, and 21D ), can be disposed within or adjacent to the hub assembly of the handle assembly (e.g., hub assembly 2230). Thus, the main tube 1902 can be an elongated tube that extends along most of the delivery system.

[0250] In some embodiments, the main tube 1902 can be a hypotube. The hypotube is a component that can be utilized to deploy the docking device and was previously described in U.S. Patent Application Publication No. 2018 / 0318079, entitled "Deployment systems, tools, and methods for delivery an anchoring device for a prosthetic valve," the disclosure of which is incorporated by reference herein in its entirety. In some embodiments, the main tube 1902 can comprise a biocompatible metal, such as stainless steel.

[0251] In various embodiments, the main tube 1902 (shown by itself in more detail in FIG. 21E) is a relatively rigid tube that provides column strength for actuating deployment of the docking device. The main tube 1902 may have a distal end 1914 at which it interfaces with the docking device, and a proximal end 1916 to which the proximal extension 1910 is attached (as discussed further below).

[0252] 21E, the main tube 1902 can have a distal section 1918 with multiple cuts 1920 that provide the main tube 1902 with increased flexibility at its distal end. Thus, the distal section 1918 may 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 the surface (e.g., the outer surface) of the main tube 1902. In alternative embodiments, the cuts 1920 can be other types of cuts formed by another cutting process (e.g., etching, scratching, cutting through the outer surface of the main tube 1902, etc.). The width and depth of the cuts 1920 can be configured to add flexibility to the main tube 1902. In some embodiments, each of the cuts 1920 can be a full-thickness push-through cut that penetrates the entirety of the 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 may be approximately 0.05 mm. In some embodiments, the width of each cut 1920 may be in the range of 0.03 mm to 0.08 mm.

[0253] In some embodiments, the spacing between adjacent cuts 1920 may vary along the length of the distal section 1918. For example, as shown in FIG. 21E , adjacent cuts 1920 may be located closest together at the distal end 1914, and then the spacing between adjacent cuts 1920 may increase from the distal end 1914 to the proximal end of the distal section 1918. In some embodiments, the cuts 1920 may be formed as helical threads cut into (and through) the outer surface of the distal section 1918 of the main tube 1902. Thus, in these embodiments, the spacing or distance between adjacent cuts 1920 may be defined as the pitch of the cuts. 21E, a first portion 1922 of the distal section 1918 can have a pitch in the range of 0.4 mm to 0.64 mm, a second portion 1924 of the distal section 1918 can have a pitch in the range of 0.64 mm to 1.2 mm, a third portion 1926 of the distal section 1918 can have a pitch of 1.2 mm, and a fourth portion 1928 of the distal section 1918 can have a pitch in the range of 1.2 mm to 3.0 mm. In some embodiments, the pitch of the first portion 1922 can increase from 0.4 mm (at its distal end 1914) to 0.64 mm along its length, the pitch of the second portion 1924 can increase from 0.64 mm to 1.2 mm along its length, the pitch of the third portion 1926 can be approximately 1.2 mm along its length, and the pitch of the fourth portion 1928 can increase from 1.2 mm to 3.0 mm along its length. The above pitch values ​​for the distal section 1918 are exemplary and other pitches are possible, and the pitch values ​​may be selected to provide the main tube 1902 with increased flexibility at its distal end 1914 and a reduced degree of flexibility along the length of the distal section 1918. In this manner, the distal section 1918 may be configured to flex and / or bend with the outer shaft 2260 of the delivery system as it is navigated through the patient's internal lumen to the target implantation site.

[0254] The main tube 1902, in some embodiments, may include one or more portions or sections with a plurality of openings 1934 configured to allow bending of an outer flexible polymer layer (e.g., a coating or jacket) disposed along a portion of the exterior surface of the main tube 1902 into an inner liner (e.g., similar to openings 1546 of sleeve shaft 1500) that is disposed along the interior surface of the main tube 1902. At the same time, the openings 1934 may be configured to provide stiffness to the pusher shaft 1900.

[0255] The embodiment of main tube 1902 shown in FIG. 21E comprises a first region 1930 and a second region 1932, each region comprising one or more apertures 1934 (e.g., through holes extending from the outer surface of main tube 1902 to the inner surface) spaced apart from one another and extending through the thickness of main tube 1902. The apertures 1934 may be spaced apart around the periphery of main tube 1902. In some embodiments, as shown in FIG. 2E, each aperture 1934 may extend entirely through main tube 1902, thereby creating two apertures 1934 spaced 180 degrees apart from one another around the periphery of main tube 1902. Additionally, in some embodiments, adjacent sets of apertures 1934 may be offset from one another by 90 degrees (e.g., as shown in FIG. 21E, first region 1930 may comprise 20 apertures).

[0256] The size and / or shape of each opening 1934 and the number and spacing between the openings 1934 in each of the first and second sections 1930, 1932 may be selected to allow the outer flexible polymer layer to be adhered (e.g., bonded) to the inner liner with the main tube 1902 disposed therebetween and still provide rigidity to the pusher shaft 1900. For example, in some embodiments, the openings 1934 may be circular with a diameter in the range of 0.4-0.6 mm. In some embodiments, the diameter of the openings 1934 may be approximately 0.5 mm. In some embodiments, the openings 1934 may have other shapes, such as oval, square, rectangular, star-shaped, triangular, etc.

[0257] In some embodiments, the openings may be spaced axially from one another along the lengths of the first and second sections 1930, 1932 by a first (center-to-center) distance 1952, and each set of openings 1934 at the same axial location may be spaced apart from an adjacent set of openings 1934 by a second distance 1954. In some embodiments, the first distance 1952 is approximately 2 mm, and the second distance 1954 is approximately 1.0 mm. In some embodiments, the first distance 1952 is in the range of 1.5 mm to 2.5 mm, and the second distance 1954 is in the range of 0.5 mm to 1.5 mm. In some embodiments, the second distance 1954 is half the first distance 1952. In alternative embodiments, a different number of openings 1934 and / or a different relative spacing and arrangement between the openings 1934 than that shown in FIG. 17E and described above is possible while still providing adequate adhesion between the inner liner and the outer flexible polymer and providing rigidity to the pusher shaft 1900.

[0258] As shown in Figure 21E, the second section 1932 is disposed at the proximal end 1916 of the main tube 1902 and includes fewer openings 1934 than the first section 1930. However, in alternative embodiments, the second section 1932 may include more openings 1934 than shown in Figure 21E. In some embodiments, the first section 1930 may include 20 openings 1934, and the second section 1932 may include 8 openings. In other embodiments, the first section 1930 may include more or fewer than 20 openings 1934, and the second section 1932 may include more or fewer than 8 openings 1934.

[0259] As shown in FIG. 21E, the main tube 1902 may include a third section 1936 disposed between and extending between the first section 1930 and a second section 1932 that does not include any openings 1934.

[0260] FIG. 21B illustrates an exemplary embodiment of materials and components of pusher shaft 1900. As shown in FIG. 21B, pusher shaft 1900 can include an inner liner 1938 that coats the inner surface of main tube 1902 and forms the inner surface of proximal extension 1910. In some embodiments, inner liner 1938 can extend along the entire length of pusher shaft 1900. The inner liner can be the same as or similar to inner layer 1606 (shown in FIG. 18). In some embodiments, the inner liner can include PTFE. Additionally, in some embodiments, the thickness of inner liner 1938 can be in the range of 0.012 mm to 0.064 mm.

[0261] Additionally, in some embodiments, a portion of the pusher shaft 1900 may include a polymer layer (also referred to as an outer covering or jacket) 1940. The polymer layer may be a flexible polymer, as described further below. In some embodiments, the outer polymer layer 1940 is disposed across and along a fourth section 1942 of the main tube 1902 (the fourth section 1942 includes the distal section 1918 and the first section 1930), while the third section 1936 of the main tube 1902 does not include the outer polymer layer 1940 ( FIGS. 21B and 21E ). In some embodiments, the outer polymer layer 1940 is also included in the second section 1932 of the main tube 1902 and forms the outer layer of the proximal extension 1910. For example, the proximal extension 1910 may include an inner liner 1938 and the outer polymer layer 1940.

[0262] The outer polymer layer 1940 can be reflow bonded across the cuts 1920 and the openings 1934. In certain embodiments, the outer polymer layer 1940 can include a polyetheramide block copolymer or a blend of two or more polyetheramide block copolymers. The polymer of the outer polymer layer 1940 can have a Shore D hardness, measured according to ISO 868:2003, of between about 60 and about 75, between about 65 and about 75, between about 70 and about 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 and about 550 MPa, between about 450 MPa and about 550 MPa, between about 500 MPa and about 550 MPa, between about 500 MPa and about 525 MPa, between about 510 MPa and 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 one or a mixture of two or more of PEBAX® grades 7033 and 7233 (Arkema SA, France) and VESTAMID® grades E62, E72, and EX9200 (Evonik Industries AG, Germany). In some embodiments, the outer polymer layer 1940 can be PEBAX® 7233. In other embodiments, the outer polymer layer 1940 can be VESTAMID® EX9200.

[0263] In some embodiments, from its distal end 1914 to its proximal end 1916, the main tube 1902 can have a uniform inner diameter ranging from about 1.0 mm to about 1.34 mm, while the outer diameter can vary between approximately 1.8 and 2.0 mm (e.g., ±0.2 mm) in the proximal and distal sections.

[0264] An exemplary embodiment of the distal tip 1942 of the pusher shaft 1900 is shown in FIG. 21C. In some embodiments, the distal tip 1942 comprises a more flexible polymer tip or distal end portion 1944 that includes a flexible polymer. In some embodiments, the polymer distal end portion 1944 may comprise the same flexible material and / or may be continuous with the outer polymer layer 1940. Thus, the polymer distal end portion 1944 of the distal tip 1942 may be reflow bonded over the distal end 1942 of the main tube 1902 and adhered to the inner liner 1938.

[0265] 21A, 21B, and 21D, the inner diameter 1948 of the outer shell 1904 is larger than the outer diameter 1950 of the main tube 1902, thereby forming an annular cavity 1946 between the main tube 1902 and the outer shell 1904 (in the radial direction). This allows the proximal portion 1504 of the sleeve shaft 1500 to slide within the annular cavity (e.g., space) 1946, as described further below with reference to FIGS. 22A-22C. Furthermore, in the hub assembly, irrigation fluid provided to a lumen on the exterior of the proximal extension 1910 can flow through the annular cavity 1946, as shown by arrows 3202, exit the distal end of the shell, and enter the lumen between the sleeve shaft 1500 and the outer shaft 2260 of the delivery system (delivery shaft lumen 3216 shown in FIG. 38), as discussed further below with reference to FIGS.

[0266] A side view of an exemplary embodiment of the outer shell 1904 of the pusher shaft 1900 is shown in FIG. 21F. The outer shell 1904 may comprise a distal section 1960, an intermediate section 1962, and a proximal section 1964. The distal section 1960 may be formed by an inner liner 1938 and an outer polymer layer 1966. In some embodiments, the outer polymer layer 1966 may comprise one of the flexible polymers described herein, such as PEBAX®. In some embodiments, the outer polymer layer 1966 may be the same or a different grade of PEBAX® as the outer polymer layer 1940 of the main shaft 1902 and / or may have the same or a different hardness as the outer polymer layer 1940. As shown in FIG. 21F, the distal end 1968 of the outer shell 1904 may have rounded edges. Together, the rounded edges of the distal end 1968 and the more flexible nature of the distal section 1960 (because it is made up of the inner liner 1938 and outer polymer layer 1966, and not a more rigid tube) can provide a more atraumatic distal tip to the outer shell 1904, thereby reducing or preventing chafing against the inner surface of the delivery system outer shaft (e.g., outer shaft 2260) that surrounds the outer shell 1904.

[0267] The intermediate section 1962 of the outer shell 1904 may comprise an inner liner 1938, an outer polymer layer 1966, and a more rigid tube 1968 disposed radially between the inner liner 1938 and the outer polymer layer 1966. In some embodiments, the tube 1968 may comprise a metal such as stainless steel. In some embodiments, the tube 1968 may be a hypotube. The tube 1968 may comprise a plurality of openings 1970 extending through the entire thickness of the tube 1968, similar to the openings 1934 in the main tube 1902, as previously described. As previously described, the size, number, and placement of the openings 1970 may be selected to provide rigidity to the second section 1962 while allowing the outer polymer layer 1966 to flow through the openings 1970 and form a firm bond to the inner liner 1938. In some embodiments, the diameter of the openings 1970 may be in the range of 1.0 mm to 1.4 mm. In some embodiments, the diameter of the opening 1970 may be approximately 1.2 mm.

[0268] The proximal section 1964 of the outer shell 1904 can include a solid tube 1968. Further, as shown in FIG. 21F , the proximal section 1964 does not include the outer polymer layer 1966 or the inner liner 1938. As shown in FIGS. 35-37 , the proximal section 1964 of the outer shell 1904 can extend into and / or into the hub assembly 2230 adjacent to where the proximal extension 1910 of the pusher shaft 1900 angles away from the cutting portion 1508 of the sleeve shaft 1500. The proximal end 1905 of the proximal section 1964 of the outer shell 1904 can be configured to receive a plug 1906, as described further below.

[0269] The plug 1906 can be configured to be disposed within the annular cavity 1946 at the proximal end 1905 of the outer shell 1904 (shown in FIGS. 21A, 21B, 21D, and 23B). In some embodiments, the plug 1906 can have a length 1907 extending in the direction of the central longitudinal axis 1901 (shown in FIG. 21A). 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.

[0270] The plug 1906 can be configured to "block" or fill a portion of the annular cavity 1946 at the proximal end 1905, while leaving a remainder of the portion of the annular cavity open to receive the cut portion 1508 of the sleeve shaft 1500. For example, as shown in the end view of FIG. 21G, in some embodiments, the plug 1906 of the pusher shaft 1900 can comprise an annular portion 1972 and a crescent-shaped portion 1974 extending radially outward from one side of the annular portion 1972. An 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 an 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, inner diameter 1976 can be selected to be slightly larger than outer diameter 1950 of main shaft 1902, and outer diameter 1978 can be selected to be slightly smaller than inner diameter 1948 of outer shell 1904 (shown in FIG. 21A). In some embodiments, inner diameter 1976 is approximately 1.81 mm and outer diameter 1978 is approximately 3.42 mm. The arc length of crescent portion 1974 can be in the range of 60-140 degrees, 80-120 degrees, 90-110 degrees, or 95-105 degrees.

[0271] The shell 1904 and plug 1906 of various embodiments are welded to the main tube 1902 to allow the cut portion 1508 of the sleeve shaft ( FIGS. 20A and 20B ) to slide between the main tube 1902 and the outer shell 1904. For example, as shown in FIG. 21D , a first weld 1980 can secure the annular portion 1972 of the plug 1906 to the main shaft 1902, and a second weld 1982 can secure the crescent-shaped portion 1974 of the plug 1906 to the outer shell 1904. In some embodiments, each of the welds 1980 and 1982 can be a tack weld that does not extend along the entire mating surfaces between the plug 1906, main shaft 1902, and outer shell 1904.

[0272] A particular embodiment of the proximal extension 1910 is shown in Figures 23A and 23B. Figures 23A and 23B show the proximal extension 1910 extending from the proximal end of the main tube 1902 and the outer shell 1904. As previously described, the proximal extension 1910 provides flexibility to the pusher shaft 1900 so that it can be routed from the inside of the sleeve shaft (e.g., the cutting portion 1508) to the outside of the sleeve shaft, thereby allowing the two shafts to actuate in parallel. In many embodiments, as previously discussed, the proximal extension 1910 can be made from a flexible polymer. In certain embodiments, the flexible polymer is a polyetheramide block copolymer or a blend of two or more polyetheramide block copolymers, such as PEBAX® grades 2533, 3533, 4033, 4533, 5533, 6333, 7033, and 7233 (Arkema SA, France) and VESTAMID® grades E40, E47, E55, E62, E72, and EX9200 (Evonik Industries AG, Germany).

[0273] Push-in shaft and sleeve shaft assembly As previously introduced, the pusher shaft 1900 and the sleeve shaft 1500 can be coaxial with one another, at least within the outer shaft 2260 (e.g., catheter portion) of a delivery system (e.g., delivery system 2220 of FIG. 24B ). FIGS. 22A-22C are assembly views showing the placement of the pusher shaft 1900 and the sleeve shaft 1500 on the outer shaft 2260 of the delivery system. Additionally, FIGS. 33 and 34 are perspective views showing an example docking device 70 ( FIG. 33 ) deployed from the outer shaft 2260 of the delivery system, covered by the distal (or sleeve) portion 1502 of the sleeve shaft 1500, and the example docking device 70 ( FIG. 34 ) after the sleeve shaft 1500 has been retracted back onto the outer shaft 2260.

[0274] 22A-22C, 33, and 34, the sleeve shaft 1500 can be configured to cover (e.g., surround) the docking device 70, and together the pusher shaft 1900 and the sleeve shaft 1500 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 described further below, FIGS. 22A-22C, 33, and 34 illustrate different stages of the implantation process.

[0275] 22A and 22B show how the proximal section 1504 of the sleeve shaft 1500, including the cutting portion 1508, passes through the proximal end portion 1912 of the pusher shaft 1900, between the main tube 1902 and the outer shell 1904, within the annular cavity 1946. Specifically, FIG. 22A shows an example of a first configuration of the pusher shaft 1900 and sleeve shaft assembly before or during deployment of the docking device 70, with the sleeve shaft 1500 positioned over the docking device 70 and the end face 1545 of the tube 1530 positioned away from the plug 1906. During deployment of the docking device 70 from the outer shaft 2260 of the delivery system, the pusher shaft 1900 and the sleeve shaft 1500 can move axially together with the docking device 70. For example, actuation of the pusher shaft 1900 to press against and move the docking device 70 out of the outer shaft 2260 can also cause the sleeve shaft 1500 to move with the pusher shaft 1900 and the docking device 70. Thereby, as shown in FIG. 33 , the docking device 70 can remain covered by the distal section 1502 of the sleeve shaft 1500 while pushing the docking device 70 through the pusher shaft 1900 into position at the target implantation site.

[0276] 22A, 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 to accommodate a thicker outer shell 1904.

[0277] 17B and shown in FIG. 33 , during delivery and implantation of the coated docking device 70 at the target implantation site, the distal tip 1512 of the distal section 1502 of the sleeve shaft 1500 can extend distally to (e.g., beyond) the distal end 1514 of the docking device 70, thereby 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 before retracting the sleeve shaft 1500 from the docking device 70 during implantation at the target implantation site. As shown in FIG. 33, in some embodiments, the distal end 1514 of the docking device 70 can be positioned adjacent to or just distal to the marker band 1552 of the sleeve shaft 1500 .

[0278] 22B shows a second configuration of the pusher shaft 1900 and sleeve shaft 1500 assembly after the docking device 70 has been deployed from the outer shaft 2260 at the target implantation site and the sleeve shaft 1500 has been retracted away from the implanted docking device 70. As shown in FIG. 22B, after implanting the docking device 70 at the target implantation site in the desired location, the sleeve shaft 1500 can be pulled out of the docking device 70 and retracted back into the outer shaft 2260. In some embodiments, the sleeve shaft 1500 can be stopped from further retraction into the delivery system when the end face 1545 contacts the plug 1906, as shown in FIG. 22B.

[0279] FIG. 34 shows the sleeve shaft 1500 removed from the docking device, leaving the docking device 70 unsheathed. As shown in FIG. 34, the distal tip 1512 of the sleeve shaft 1500 may be positioned proximal to (e.g., retracted beyond) the distal end of the pusher shaft 1900, which may still be coupled to the end of the docking device 70 via a suture 2236. After implanting the docking device 70 at the target implantation site as described further below and removing the distal portion 1504 of the sleeve shaft 1500 from the docking device's sheath, the docking device 70 may be uncoupled from the delivery system by severing the suture 2236 via a suture lock assembly of the delivery system (e.g., the suture lock assembly 2206 shown in FIG. 24A and / or the suture lock 2700 shown in FIGS. 27A-29D).

[0280] 22C, certain embodiments include a sealing feature 1908 located on the main tube 1902 of the pusher shaft 1900 of some embodiments. The sealing feature 1908 in some embodiments forms a seal between the main tube 1902 of the pusher shaft 1900 and the sleeve shaft 1500 to prevent fluids being forced through the system from backflowing or finding a path of less resistance through another lumen (as further described below with reference to FIGS. 35-38). Certain embodiments use a gasket made from plastic, rubber, PTFE, PBAX, or other suitable material that is placed on the main tube 1902 of the pusher shaft 1900. In embodiments that use a gasket, the gasket is glued in place by fusing the gasket to the main tube 1902, although some embodiments attach the gasket using a glue or other adhesive. Additional embodiments manufacture the main tube 1902 to include a ridge or protrusion on the main tube 1902 that extends toward the sleeve shaft 1500 as the sealing feature 1908, while certain embodiments form a ridge or protrusion on the sleeve shaft 1500 that extends toward the main tube 1902 as the sealing feature. Certain embodiments include multiple sealing features 1908 to form a seal between the main tube 1902 of the pusher shaft 1900 and the sleeve shaft 1500 with any combination of ridges and / or gaskets. Additional embodiments further include a gasket positioned toward the proximal end of the sleeve shaft 1500 (e.g., gasket 1804 in FIG. 20A ) in addition to one or more sealing features 1908.

[0281] Handle System As previously introduced, a delivery system (e.g., delivery system 2220 of FIG. 24B ) may include a handle assembly 2200 configured to control operation of the delivery system, including the pusher shaft and sleeve shaft. The handle assembly may be configured in a variety of ways with one or more of various components, handles, hubs, connectors, knobs, shafts, etc. An example embodiment of the completed handle assembly 2200, as previously described, is shown in FIG. 24B . As shown in FIG. 24A and previously introduced, the handle assembly 2200 of some embodiments includes a hub assembly 2230, which in some embodiments may include a Y-shaped connector (e.g., an adapter) having a straight section (e.g., a straight conduit) 2202 and at least one branch (e.g., a branch conduit) 2204 (which may include two or more branches in some embodiments).

[0282] In some embodiments, a suture lock assembly (e.g., suture lock) 2206 can be attached to the bifurcated portion 2204, and a sleeve actuation handle 2208 (which can be similar to the sleeve handle 2234 of FIG. 24B ) can be disposed at the proximal end of the straight section 2202. The hub assembly 2230 can be adapted and configured to allow the proximal extension 1910 of the pusher shaft 1900 (or other similar pusher shaft) to extend into the suture lock assembly 2206 disposed at the end of the bifurcated portion 2204, while the cutting portion 1508 of the sleeve shaft 1500 extends into the sleeve actuation handle 2208 disposed at the end of the straight section 2202. With this configuration, a medical professional can deploy a docking device (e.g., docking device 2232 of FIG. 24B and / or docking device 70 of FIGS. 9A-12B and 22A-22C) by manipulating the position of handle assembly 2200 (e.g., moving handle assembly 2200 axially), and can also retract the sleeve shaft (away from the implanted docking device) by pulling axially back on sleeve actuation handle 2208. Thus, such a handle configuration may only add one additional step when retracting the sleeve shaft compared to delivery systems that do not include other removable covers for the sleeve shaft or docking device.

[0283] The sleeve shaft and pusher shaft assembly can be configured to move together such that the sleeve shaft and pusher shaft can be moved simultaneously when deploying and positioning the docking device in the native valve (e.g., by moving the entire hub assembly 2230 axially forward and / or backward), but can also move independently so that the pusher shaft 1900 can hold the docking device in place while the sleeve shaft 1500 is retracted away 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 docking device while pulling proximally on the sleeve actuation handle 2208 to retract the sleeve). As previously introduced and shown in FIGS. 22A-22C , the sleeve shaft 1500 and pusher shaft 1900 can be coaxial along some, all, or most of the delivery system to facilitate this movement.

[0284] The handle assembly 2200 may include one or more irrigation ports to allow irrigation of various lumens disposed between axially extending components of the delivery system (e.g., annular spaces disposed between components, such as coaxial shafts). For example, as shown in FIG. 38 , which illustrates a distal end portion of a delivery system (e.g., delivery system 2220) including a pusher shaft (e.g., pusher shaft 1900) and a sleeve shaft (e.g., sleeve shaft 1500) disposed within the delivery system outer shaft 2260, various lumens configured to receive irrigation fluids during the delivery and implantation procedure are formed between the docking device 70, the pusher shaft 1900, the sleeve shaft 1500, and the outer shaft 2260. A first pusher shaft lumen 3210 may be formed within the interior of the pusher shaft (e.g., within the interior of the main tube 1902). The pusher shaft lumen 3210 can receive irrigation fluid from a first fluid source, which can be fluidly coupled to a portion of the handle assembly (e.g., a branch 2204 as described further below). The irrigation fluid flow 3204 through the pusher shaft lumen 3210 can proceed along the length of the main tube 1902 of the pusher shaft 1900 to the distal end 1914 of the pusher shaft 1900. As shown in FIG. 38 , the distal end 1914 of the pusher shaft 1900 can be spaced from the proximal end of the docking device 70 so that at least a portion of the irrigation fluid flow 3204 can flow as irrigation fluid flow 3208 to a first portion 3212 of a second sleeve shaft lumen disposed between the outer surface of the docking device 70 and the inner surface of the distal section 1502 of the sleeve shaft 1500. Additionally, in some embodiments, a portion of the flow of irrigation fluid 3204 can also flow as flow of irrigation fluid 3206 to a second portion 3214 of the sleeve shaft lumen that is disposed between the outer surface of the pusher shaft 1900 and the inner surface of the sleeve shaft 1500. In this manner, the same first fluid source can provide irrigation fluid via the pusher shaft lumen 3210 to each of the pusher shaft lumens 3210, the first portion 3212 of the sleeve shaft lumen, and the second portion 3214 of the sleeve shaft lumen.

[0285] 38 , a third delivery shaft lumen 3216 can be formed in the 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 be fluidly coupled to a portion of the handle assembly (e.g., the bifurcation 2204 and / or the handle 2222 as described further below) and can receive irrigation fluid from one or more second fluid sources that can provide a flow of irrigation fluid 3202 that flows through the delivery shaft lumen 3216 to the distal end of the outer shaft 2260.

[0286] Flush- ing the lumens described above is important to prevent thrombus formation in and around the docking device and other concentric components of the delivery system during deployment of the docking device from the delivery apparatus and during implantation of the docking device at the target implantation site. To flush these lumens, various embodiments possess one or more flushing (flush) ports disposed on and / or coupled to the handle assembly 2200 of the delivery system. Figures 24A, 24B, 28A, 35, and 36 illustrate different embodiments of possible flushing port placements configured to provide flushing fluid to the lumens described above in connection with Figure 38. Figure 37 also illustrates the flow of flushing fluid through a portion of the delivery system disposed between the hub assembly 2230 (as shown in Figures 24A, 35, and 36) and the distal end portion of the delivery system (as shown in Figure 38).

[0287] In a first embodiment of flushing port placement, the handle assembly 2200 may include two flushing ports positioned at the bifurcation 2204 (which may also be referred to as the suture locking bifurcation) of the hub assembly 2230, where one of the flushing ports provides a flow of flushing fluid 3204 to the pusher shaft lumen 3210 and the other of the flushing ports provides a flow of flushing fluid 3202 to the delivery shaft lumen 3216. For example, the two flushing ports at the bifurcation 2204 may include a first flushing port 2210 and a second flushing port 2216, where the first flushing port 2210 is positioned proximal to the second flushing port 2216 at the bifurcation 2204. In some embodiments, the location of the second flushing port 2216 at the bifurcation 2204 may be closer or farther from the first flushing port 2210 than shown in FIGS. 24A , 35 , and 36 .

[0288] As shown in FIGS. 24A, 35, and 36, the first flush port 2210 has an internal flow lumen that is fluidly connected to an internal cavity 2250 at the bifurcation 2204. An open proximal end 2252 of the proximal extension 1910 of the pusher shaft 1900 may be fluidly coupled to and / or disposed within the internal cavity 2250 (shown in FIGS. 24A, 35, and 36). As previously described, the proximal extension 1910 routes through the bifurcation 2204 to 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. As a result, the flow of flushing fluid 3204 from the first flushing port 2210 enters the pusher shaft lumen 3210 at the proximal end 2252 of the proximal extension 1910, passes throughout the main tube 1902 of the pusher shaft, and continues to the distal end 1914 (shown in FIG. 38).

[0289] The second flushing port 2216 surrounds the exterior of the proximal extension 1910 within the bifurcation 2204 and has an internal flow lumen that is fluidly connected to an elongated space or cavity 2254 (which may be annular along at least a portion of the cavity) that extends into the straight section 2202 in the space between the proximal extension 1910 and the inner surface of the cutting portion 1508 of the proximal section 1504 of the sleeve shaft 1500. Thus, a flow of flushing fluid 3202 from the second flushing port 2216 can enter the cavity 2254, pass through the cavity 2254, and flow around the proximal extension 1910 to the annular cavity 1946 ( FIG. 37 ). As previously described with reference to Figures 21A and 22A, the flow of irrigation fluid 3203 can flow through the annular cavity 1946, as shown by arrow 3202 in Figures 21A and 22A, to enter the delivery shaft lumen 3216 and exit the distal end of the outer shell 1904.

[0290] 24B and 35, the delivery shaft lumen 3216 may be provided with additional irrigation fluid (in addition to the fluid from the second irrigation port 2216) from a third irrigation port 2218 that is fluidly coupled to the annular cavity 1946 downstream of the plug 1906 (e.g., distal to the plug 1906). In this manner, in some embodiments, the supplemental irrigation fluid 3218 may be combined with the irrigation fluid flow 3202 and supplied to the delivery shaft lumen 3216. In some embodiments, as shown in FIGS. 24B and 35, the third irrigation port 2218 may be located in a portion of the handle 2222. In alternative embodiments, the third irrigation port 2218 may be located at a more distal location on the handle than shown in FIGS. 24B and 25. In some embodiments, the third irrigation port 2218 may not be used during the implantation procedure, and instead may only be used to irrigate the delivery shaft lumen 3216 prior to insertion of the delivery system into the patient. In some embodiments, the delivery system may not include a third flush port 2218.

[0291] Various embodiments of the hub assembly 2230, including the first embodiment of the flushing port arrangement described above, can include a gasket 2211 positioned within the branch 2204 between the two flushing ports at the branch 2204 to create separate, distinct fluid flow lumens fed by the two flushing ports at the branch 2204 (e.g., the first flushing port 2210 and the second flushing port 2216 shown in FIGS. 24A , 35 , and 36 , or the second flushing port 2216 and the flushing port 2806 shown in FIG. 28A ). For example, the gasket 2211 can be configured as a disk with a single (e.g., a central, in some embodiments) hole configured to tightly receive the proximal extension 1910. The gasket 2211 may not include an additional hole and may be further configured to provide a seal between the internal cavity 2250 and the cavity 2254. As a result, all of the flow of irrigation fluid 3204 entering the internal cavity 2250 from the first irrigation port 2210 (or alternatively, from the irrigation port 2806, as described further below) can enter the push shaft lumen 3210 without entering the cavity 2254 and without flowing to the delivery shaft lumen 3216. Similarly, all of the flow of irrigation fluid 3202 entering the cavity 2254 from the second irrigation port 2216 can enter the annular cavity 1946 and the delivery shaft lumen 3216.

[0292] In a second embodiment of the flushing port placement, the handle assembly 2200 may include two flushing ports located at a bifurcation 2204 (which may also be referred to as the suture locking bifurcation) of the hub assembly 2230, one of the flushing ports providing a flow of flushing fluid 3204 to the pushing shaft lumen 3210 and the other of the flushing ports providing a flow of flushing fluid 3202 to the delivery shaft lumen 3216. However, in the second embodiment, the flushing port providing a flow of flushing fluid 3204 to the pushing shaft lumen 3210 may be located at the proximal end of the bifurcation 2204, at the end of the suture lock assembly (e.g., the suture lock assembly 2206 of FIGS. 24A and 24B or the suture lock assembly 2700 of FIGS. 27A-29D). 28A, the flow of irrigation fluid 3204 may be provided through an irrigation port 2806 located at the proximal end of the suture lock assembly 2700. In this manner, the flow of irrigation fluid 3204 may be provided to the pusher shaft lumen 3210 through an irrigation port (e.g., irrigation port 2806) with the flow lumen positioned parallel to the pusher shaft lumen 3210 (instead of perpendicular to the pusher shaft lumen 3210 as shown in FIGS. 24A, 24B, 35, and 36).

[0293] Embodiments of the flushing port arrangement possessing multiple flushing ports, such as the first and second embodiments described above, may be supplied with flushing fluid independently (e.g., from two separate fluid sources) or together from a common fluid source. For example, in some embodiments, each flushing port (e.g., the first flushing port 2210 and the second flushing port 2216, or the flushing port 2806 and the second flushing port 2216) may be supplied with flushing fluid from two separate infusion pumps (one fluidly coupled to each of the flushing ports) or from separate sets of fluid sources. In alternative embodiments, a single infusion device (e.g., pump) 3220 may be coupled to multiple flushing ports, such as through a Y-connector 3222 that connects a single fluid line to multiple flushing ports, as shown in FIG. 35. As shown in FIG. 35, the first flushing port 2210 and the second flushing port 2216 are supplied with fluid from the same source (e.g., an infusion pump 3220). In some embodiments, the infusion pump 3220 can supply fluid to the flush port 2806 and the second flush port 2216 .

[0294] It may be desirable to balance the flow of irrigation fluid between the lumens so that the flow of irrigation fluid is equal in each lumen. However, in some embodiments, the flow of irrigation fluid through the push shaft lumen 3210 may have increased resistance relative to the delivery shaft lumen 3216. In one example, the increased resistance may be due to a narrower flow lumen and / or friction between the sheath (e.g., sheath 100 in FIGS. 12A-12D ) and the sleeve section of the sleeve shaft (e.g., sleeve 1502 in FIG. 17 ). As one example, an additional irrigation port may be added to supplement the flow in the push shaft lumen 3210 to equalize the flow between the lumens. As another example, two separate infusion devices may be used to provide the desired flow rates of irrigation fluid to the push shaft lumen 3210 and the delivery shaft lumen 3216. As yet another example, when using a single infusion device to supply both flushing ports, the resistance in the delivery shaft lumen 3216 can be increased to equalize the relative resistance between the delivery shaft lumen 3216 and the push shaft lumen 3210. For example, certain embodiments can vary the flow rate of fluid accepted by the delivery shaft lumen 3216 and the push shaft lumen 3210 from the single infusion device 3220 by changing the inner diameter of one or both of the line port lumens (e.g., reducing the diameter of the inner lumen of the second flushing port 2216 relative to the first flushing port 2210), the diameter of the bifurcation portion of the Y-connector 3222, or other components to vary the relative flow into the cavity 2254 (feed into the delivery shaft lumen 3216) and the push shaft lumen 3210.

[0295] In this method, it may be desirable to equalize the resistance to fluid flow between the flow paths in and / or to the pusher shaft lumen 3210 and the flow paths in and / or to the delivery shaft lumen 3216, so that the lumens receive equal flows of irrigation fluid from a single source (e.g., a single infusion device 3220). Various embodiments may include varying the resistance of one or more components in one of the two flow paths (e.g., the flow path in the pusher shaft lumen or the flow path in the delivery shaft lumen) and / or providing one or more devices that measure the uniform flow rate of irrigation fluid to each of the pusher shaft lumen 3210 and the delivery shaft lumen 3216. Thus, the flow of irrigation fluid to these two lumens may be controlled by any method known in the art to ensure equal flow rates in the lumens based on their respective relative resistances. Furthermore, during the implantation procedure, differences in flow resistance may be experienced within each of the push shaft lumen 3210 and the delivery shaft lumen, and between the push shaft lumen 3210 and the delivery shaft lumen. Therefore, it may be desirable to deliver irrigation fluid flow to these lumens either individually (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).

[0296] Some embodiments can include mechanisms (sensors, warning devices, etc.) for detecting when the flow rate of the irrigation fluid drops below a preset threshold flow rate in one or more of the lumens receiving the irrigation fluid (e.g., the push shaft lumen and the delivery shaft lumen). For example, the infusion device may possess a warning device to alert a medical professional or user to a possible interruption in flow due to a blockage in the system by a blood clot. A blood clot could cause a stroke if dislodged during installation of the docking device. A blood clot could also increase the force experienced during removal of the distal portion of the sleeve shaft 1500 from the docking device by causing increased friction between the sleeve and the docking device. As an example, the use of two infusion devices allows certain embodiments to identify when a blood clot forms in one or more of the lumens, including when flow across the lumen is prevented with a gasket or other sealing mechanism (e.g., gasket 1804 shown in FIG. 20 or sealing mechanism 1908 shown in FIG. 22C). Further embodiments utilize a single infusion device coupled to multiple flushing ports and the use of flow sensors coupled to the flow tubing (and / or alarm devices) to notify medical personnel of changes in flow rate that may indicate a blockage such as a blood clot.

[0297] In a third embodiment of an irrigation port arrangement, the handle assembly 2200 can include a single irrigation port disposed at the bifurcation 2204 of the hub assembly 2230, the single irrigation port configured to provide a flow of irrigation fluid 3204 to the push shaft lumen 3210 and a flow of irrigation fluid 3202 to the delivery shaft lumen 3216. For example, certain configurations can irrigate all of the previously described lumens with only one irrigation line, such as the first irrigation port 2210 (or alternatively, the irrigation port 2806 shown in FIG. 28A ). In such an embodiment, the single irrigation port can provide fluid to two separate lumens (the push shaft lumen 3210 and the delivery shaft lumen 3216) by incorporating an irrigation plate 2300 (shown in FIG. 25 ) at the bifurcation 2204, perpendicular to the flow path through the push shaft lumen 3210 and the cavity 2254. For example, in some embodiments, the cleaning plate 2300 may be positioned where the gasket 2211 is shown in FIG. 36 (e.g., with the gasket 2211 in place and the second cleaning port 2216 absent), or further downstream from where the gasket is shown.

[0298] Figure 25 shows a irrigation plate 2300 that can be used in various embodiments. As shown in Figure 25, the irrigation plate 2300 can have openings or holes 2301a, 2301b, and 2301c cut in the irrigation plate 2300 to equalize resistance among the various lumens. The openings / holes 2301a, 2301b, and 2301c cut into the irrigation plate 2300 are designed to equalize the flow of irrigation fluid from the holes to each lumen, thereby ensuring that an adequate flow of irrigation fluid is provided to both the push shaft lumen 3210 and the delivery shaft lumen 3216.

[0299] Returning to FIG. 24A , in some embodiments, a hemostatic seal (such as the hemostatic seal 2400 shown in FIGS. 26A and 28B ) is used to seal around the cutting portion 1508 of the proximal section 1504 of the sleeve shaft 1500, adjacent the sleeve actuation handle 2208. FIG. 26A illustrates the hemostatic seal 2400 according to various embodiments. As seen in FIG. 26A , the hemostatic seal 2400 can have an opening 2406 in the shape of a cross-section of the cutting section 1508 of the sleeve shaft 1500, such as a U-shape or an incomplete (or partial) annulus, configured to receive the cutting portion 1508 and seal on all sides of the sleeve shaft 1500. FIG. 26B illustrates the hemostatic seal 2400 in operation positioned within the straight section 2202 of the hub assembly 2230, according to many embodiments. 26B, two rigid washers 2402 and 2404 can support each end of the hemostatic seal 2400. The rigid washers 2402, 2404 can possess the same outer shape as the hemostatic seal 2400 to maintain the integrity of the hemostatic seal 2400. In some embodiments, the rigid washers 2402, 2404 apply inward pressure to the hemostatic seal 2400 to ensure a seal between the hemostatic seal 2400 and the cutting portion 1508 of the sleeve shaft 1500. Looking back to FIG. 24A, this hemostatic seal 2400 can be positioned near the sleeve actuation handle 2208, such as at location 2212 in many embodiments. By positioning 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 adjustment of the inward pressure applied to the hemostatic seal to apply additional pressure to the sleeve shaft to lock and / or immobilize the sleeve shaft 1500 (e.g., from axial translation relative to the remainder of the hub assembly 2230 and the pusher shaft 1900).

[0300] 24A and 24B, and as previously introduced, a delivery system may include a suture lock assembly 2206 positioned in a bifurcated portion 2204 of a hub assembly 2230 of a handle assembly 2200. FIGS. 27A-29D show an embodiment of a ratcheting suture lock 2700 that may be used as the suture lock assembly 2206 of the delivery system 2220 of FIGS. 24A and 24B. The hub assembly 2230 may be adapted and configured to allow a proximal extension of the pusher shaft (e.g., proximal extension 1910) to extend into the suture lock 2700 at the end of the bifurcated portion 2204, while the sleeve shaft (e.g., sleeve shaft 1500) extends into a sleeve actuation handle 2208 at the end of the straight section 2202 (e.g., as shown in FIG. 27A).

[0301] An additional embodiment of a hub assembly including a suture lock 2700 as shown in FIG. 27A includes irrigation tubing 2216 to allow irrigation of one or more lumens within the delivery device (e.g., delivery shaft lumen 3216) to maintain hemostasis within the delivery device and / or to sterilize the delivery device (as described above with reference to FIGS. 35-38). Similar to the system shown in FIGS. 24A and 24B, the medical professional only needs to add one additional step to actuate deployment of the docking device by manipulating the position of the handle assembly 2200 and retract the sleeve by pulling back on the sleeve actuation handle 2208. The sleeve assembly and pusher assembly can be configured to operate together such that they can be moved simultaneously when deploying and positioning the docking device in the native valve (e.g., by moving the hub assembly and / or Y-connector entirely forward and / or backward), or they can move independently so that the pusher / pusher shaft can hold the docking device in place while the sleeve is retracted from the docking device (e.g., by holding the hub assembly and / or Y-connector in place relative to the main shaft of the delivery system and / or other components of the delivery system and / or docking device while pulling proximally on the sleeve actuation handle 2208 to retract the sleeve). The sleeve shaft and pusher shaft can be coaxial along some, all, or most of the delivery system to facilitate this operation, as described above.

[0302] As shown in Figures 27A-28A and 29C, the suture lock 2700 of many embodiments includes a rotator 2702 (which may also be referred to as a rotatable handle) for increasing or decreasing tension on a suture 2812 (shown in Figures 28B-28D) that may extend from the suture lock 2700, through the branch 2204, and through the delivery system for coupling to a docking device (e.g., similar to the release suture 2236 shown in Figures 24B and 34).

[0303] In many embodiments, the suture 2812 is wound around a spool 2930 of the suture lock 2700 (FIGS. 27C, 29C, and 29D). The rotator (e.g., handle) 2702 can be coupled to the spool 2930 such that in a given rotation, the rotating rotator 2702 adjusts (e.g., increases or decreases) the tension on the suture 2812 traversing the delivery device (e.g., delivery system 2220). Providing tension or slack on the suture 2812 by rotating the rotator 2702 (and thus the spool 2930) moves the docking device closer to or farther from the delivery system, respectively.

[0304] 27B , in some embodiments, rotor 2702 may include one or more gripping portions or grips that increase the ease of grasping rotor 2702 (e.g., via a user's hand). For example, rotor 2702 may include a first gripping portion 2703 disposed around the periphery of rotor 2702 and configured to be grasped by a user during rotation of rotor 2702. In some embodiments, first gripping portion 2703 may include a plurality of ridges to increase friction and ease of grasping. Rotor 2702 may further include a second gripping portion 2701 disposed on an upper surface of rotor 2702. Additionally, in some embodiments, first gripping portion 2703 and / or second gripping portion 2701 may include a material having a lower durometer (e.g., reduced hardness).

[0305] In some embodiments, the suture lock 2700 may further comprise a directional control mechanism, which may comprise a direction selection device 2704 (e.g., in the form of a switch, as shown in FIGS. 27A-27C ) that allows a medical practitioner or other user to select whether to increase or decrease slack in the suture 2812 across the delivery device. For example, the direction selection device 2704 of various embodiments may allow the medical practitioner or other user to select a direction (e.g., increase or decrease tension) that will cause the rotator 2702 to rotate in only one direction, preventing directional errors by the medical practitioner or other user.

[0306] 27C and 29A, the spool 2930 can include a gear 2902 that can engage with a pawl 2904, which allows rotation of the gear 2902, and thus the rotor 2702 and spool 2930, in only one direction. The direction in which the rotor 2702 can be rotated depends on the orientation of the pawl 2904, which is controlled by the direction selection device 2704. In some embodiments, as shown in FIGS. 27A and 27C, the upper housing 2710 can include a first icon 2706 that indicates a slack position of the direction selection device 2704 and a second icon 2708 that indicates a tensioned position of the direction selection device 2704.

[0307] As shown in FIG. 29A , in some embodiments, the directional control mechanism can be a ratcheting mechanism that limits directional movement from the rotor 2702 by a medical practitioner or other user. As shown in FIGS. 27B, 27C, and 29A , the gear 2902 is attached to the rotor 2702, while the pawl 2904 is attached to the direction selection device 2704. The pawl 2904 can be designed to engage with teeth 2910 on the gear 2902 so that the gear 2902 can only rotate in one direction at a time. When the pawl 2904 is actuated (e.g., pivoted) into a position (e.g., tensioned or loosened), a spring plunger 2906 engages behind the pawl 2904, thereby holding the pawl 2904 in the selected orientation / position (shown in FIGS. 27C and 29A ). When engaged in one direction, one or more teeth 2908 on the pawl 2904 interact with teeth 2910 on the gear 2902. A stop 2912 may also be created to prevent the pawl 2904 from moving in both directions, thereby only moving the gear 2902 in one direction. The stop 2912 can be constructed in several ways, including making it part of the upper housing 2710 or adding additional material (e.g., pins, spacers, etc.) inside the upper housing 2710 to prevent the pawl 2904 from moving in both directions.

[0308] Figure 29E is a diagram 2950 illustrating an example operation of the directional control mechanism shown in Figure 29A. As shown in Figure 29E, when directional selection device 2704 is in a relaxed position (e.g., pointing to first icon 2706, as shown in Figure 27A), when rotor 2702 is rotated counterclockwise, pawl 2904 is pushed clockwise by gear 2902 to allow rotation (shown in box 2952 in diagram 2950). When tooth 2910 of gear 2902 passes tooth 2908 of pawl 2904, spring plunger 2906 pushes pawl 2904 counterclockwise to engage with the gear tooth next to gear 2902. When the rotor 2702 is rotated clockwise (e.g., with the direction selection device 2704 in the loose position), the gear 2902 rotates the pawl 2904 counterclockwise until it hits a hard stop 2912 on the upper housing 2710 (e.g., shown in FIG. 29A and box 2954 in diagram 2950). As previously introduced, this hard stop 2912 prevents further rotation of the spool 2930 and bears the load from resisting rotation rather than the teeth 2908 of the pawl 2904. When the direction selection device 2704 is moved to the tensioned position, the spool 2930 can only rotate clockwise (shown in boxes 2956 and 2958 in diagram 2950) due to the same mechanism previously described for the loose position. In some embodiments, the hard stop 2912 is designed to engage while the spring plunger 2906 is still engaged with the pawl 2904, which can prevent a loose feeling in the directional selection device 2704 while not in use.

[0309] 29B-29D show additional embodiments of directional control mechanisms for suture locks, such as suture lock 2700, that include a clutch system. The clutch system can be configured to limit the amount of tension that can be applied to a suture (e.g., suture 2812) to avoid potential damage or deterioration to the delivery system and / or docking device.

[0310] 29B , some embodiments show a directional control mechanism having a clutch that uses friction pads to disengage spool 2930 from rotor 2702 and transfer torque from rotor 2702 to spool 2930. Specifically, FIG. 29B shows a side cross-sectional view of a portion of a suture lock (e.g., suture lock 2700) in which rotor 2702 is coupled to a central screw 2916, with a friction control nut 2918 coupled near the distal end of central screw 2916. Central screw 2916 extends through the center of spool 2930 and is coupled to spool 2930. Friction pads 2920 are positioned above and below a central portion of spool 2930 around central screw 2916 such that over-rotating rotor 2702 in one direction causes increased friction on central screw 2916, thereby preventing further rotation. For example, if the tension on the suture reaches a predetermined threshold, when the rotor 2702 is rotated, the increased friction from the friction pad 2920 prevents the spool 2930 from being rotated.

[0311] In an alternative embodiment, as shown in FIGS. 29C-29D, a pin-based clutch system is illustrated for use in certain embodiments. In such an embodiment, a spring plunger 2922 transfers torque from rotor 2702 to spool 2928 (which may be similar to spool 2930). Spring plunger 2922 bears against (e.g., engages with) detents 2924 on gear 2926 (which may be similar to gear 2902 and may be used similarly) to allow driving of spool 2928 to increase or decrease tension on the suture. Detents 2924 may be located on the outward-facing surface of gear 2926, with a line perpendicular to the outward-facing surface aligned perpendicular to the circumferential surface of the gear, including the gear teeth. At a designed suture tension (e.g., tension above a predetermined threshold), spring plunger 2922 may slide out of one of the detents and move to an adjacent (e.g., next) detent 2924. In this manner, when the rotor 2702 is rotated beyond a certain position, the spring plunger 2922 retracts, thereby preventing further rotation of the rotor 2702 and reducing damage to the docking device and / or delivery system due to excessive tension being applied to the suture, which may only be a risk when tension is applied to the suture. Thus, the detent 2924 may be designed to only slip in the tensioned configuration and not slip in the relaxed configuration.

[0312] 27A-27C and 28A-28B, in some embodiments, the suture lock may include a connector or coupling portion for attaching the suture lock 2700 to a handle assembly (e.g., handle assembly 2200 of FIG. 27A). For example, the suture lock 2700 may include a release bar 2820 that extends into and couples with the lower housing 2712 of the suture lock 2700 (FIGS. 27B-28C). In some embodiments, the release bar 2820 is adhered to the lower housing 2712 (e.g., via adhesive, welding, or other non-removable fastening means). As shown in FIG. 27B and 28A-28C, a release knob 2802 may be disposed around a portion of the release bar 2820 adjacent to the coupling portion 2822 of the lower housing 2712. The release knob 2802 can be configured to couple the suture lock 2700 to an adapter 2270 of a delivery system. In some embodiments, as shown in FIG. 27A , the adapter 2270 can include a bifurcated portion 2204 and a straight portion 2202, as previously discussed. For example, the release knob 2802 can be threaded onto the end 2272 of the adapter 2270 to secure the suture lock 2700 to the adapter 2270. In some embodiments, the shape, size, and / or configuration of the adapter 2270 can differ from that shown in FIG. 27A and can vary based on the delivery system to which the suture lock 2700 is configured to be attached (and used with).

[0313] For example, in some embodiments, when the teeth of the release knob 2802 engage both the end 2272 of the adapter 2270 (or other adapter of a delivery system) and the release bar 2820, the suture lock 2700 is coupled to the delivery system and the suture cutting area 2804 is covered by the adapter 2270 (shown in FIGS. 27A, 28B, and 28C). In some embodiments, once the docking device (or other implant) is positioned in a desired position for release from the delivery system, the release knob 2802 can be loosened 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 area 2804. In an alternative embodiment, rotation of the release knob 2802 towards the bottom housing 2712 can expose the suture cut area 2804 without pulling the entire suture lock 2700 from the adapter 2270.

[0314] The suture cutting area 2804 can cut the suture 2812 that traverses the length of the delivery system (e.g., as shown as suture 2236 in Figures 24B and 34) to allow a user or medical practitioner to uncouple the docking device from the delivery system upon placement in the heart or heart analog.

[0315] In some embodiments, once the suture 2812 has been wrapped around a docking device or implant (e.g., as shown in FIGS. 24B and 34 ) and routed through the delivery system, through the release bar 2820 (including over the suture cutting area 2804 as shown in FIG. 28B ), and into the lower housing 2712, the two suture ends of the suture 2812 may be threaded through two openings 2932 located at the bottom end of the spool 2930 (or spool 2928 in FIG. 29 ) and then knotted to complete the loop. As shown in FIG. 29D , the spool 2928 (or 2930) may include a gap 2934 in the flange at the bottom of the spool 2928 that can prevent the suture 2812 from being crushed during assembly of the upper and lower housings 2710 and 2712.

[0316] In some embodiments, as shown in FIG. 27A, the rotor 2702 may include an indicator 2714 to track the number of turns applied and to locate the thread winding gap 2934.

[0317] 28C and 28D , the suture 2812 extends longitudinally through the release bar 2820 of the suture lock 2700, and the two strands of suture split to traverse a splitter 2814 located in the suture cutting area 2804. Various embodiments use the splitter 2814 to separate the strands of suture 2812 so that only one strand can be cut by a user or medical practitioner to release the docking device from the delivery device. For example, the exposed portion of the suture 2812 can then be cut by a cutting mechanism, such as the cutting mechanism of FIGS. 30A-30C , as shown in FIG. 28D . Once the suture is cut, it can be removed from the delivery system, and the suture lock 2700 can be attached back to the adapter 2270 of the delivery system by threading the release knob 2802 onto the adapter 2270.

[0318] Additional embodiments maintain a seal within the suture lock 2700 using multiple annular sealing elements (e.g., O-rings) 2816a-2816c to prevent leakage of blood, saline, or other liquids through the system. For example, as shown in FIGS. 27C, 28C, 29B, and 29C, the suture lock 2700 may include a first distal release bar O-ring 2816a (FIGS. 27C and 28C), a second proximal release bar O-ring 2816b (FIGS. 27C and 28C), and a spool O-ring 2816c (FIGS. 27C, 29B, and 29C). These O-rings 2816a-2816c can be configured to seal the suture pathway when the suture lock 2700 is assembled, allowing for hemostasis when coupled to a properly sealed delivery system. The spool O-ring 2816c can prevent leakage past the end of the suture path. The proximal release bar O-ring 2816b can prevent leakage between the release bar 2820 and the lower housing 2712. In some embodiments, this allows the adhesive or other adhesive medium that bonds the release bar 2820 to the lower housing 2712 to act only as an adhesive and does not require a sealing function. The distal release bar O-ring 2816a can prevent leakage between the release bar 2820 and the delivery system adapter 2270 while the release knob 2802 is engaged. The release knob 2802 can be designed so that the distal release bar O-ring 2816a seals the suture locking mechanism when there is threaded engagement with the adapter 2270 (e.g., there may be no variable seal depending on how tight the release knob is). In some embodiments, there may be holes in the lower housing 2712 to act as a leak path in the event of seal degradation.

[0319] As introduced above with reference to FIG. 38 , additional embodiments of the suture lock 2700 include an irrigation port 2806 to allow irrigation 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 irrigation port 2806 allows certain embodiments of the delivery device to independently irrigate lumens if a single irrigation line becomes clogged and / or does not maintain hemostasis in the delivery device. In certain embodiments, the irrigation port 2806 is an open port that allows constant flow through the delivery device, although certain embodiments retain a self-sealing irrigation port 2806 such that constant flow is not required and fluid can be introduced into the delivery device as needed by the practitioner. The irrigation port 2806 as shown in FIG. 28A can have additional irrigation lines connected to it, similar to multiple irrigation ports such as those shown in FIG. 24B and discussed above.

[0320] 28B and 28D , some embodiments of the suture lock 2700 possess keyed sections to prevent rotation of the suture lock 2700 about the handle assembly, thereby preventing twisting of the suture line and / or increasing ease of access for the practitioner. The keyed components of a particular suture lock 2700 can be achieved in a variety of ways, including creating specific non-round shapes in the components, the use of pins, grooves, or any other methodology for maintaining a non-rotational fit between the suture lock 2700 and the outer housing of the handle assembly. For example, in some embodiments as shown in FIG. 28B , either end of the release bar can be shaped to form keyed connections 2808 a and 2808 b between the release bar 2820 and the lower housing 2712 and between the release bar 2820 and the adapter 2270, respectively. For example, the proximal end 2824 of the release bar 2820 can be shaped to form a first keyed connection 2808a, and the distal end 2826 of the release bar 2820 can be shaped to form a second keyed connection 2808b.

[0321] 28D , the release bar 2820 includes one or more support members 2828 disposed in a central portion of the release bar, the central portion being disposed between the distal end 2826 and the proximal end 2824 of the release bar 2820. For example, in some embodiments, the support member 2828 can include a plurality of axially extending members 2828 disposed around the periphery of the release bar 2820 on either side of a central hoop element 2830 that extends around the periphery of the release bar 2820.

[0322] FIGS. 30A-30C illustrate a cutting and suture removal system for use in various embodiments. Such embodiments allow a user to cut and remove sutures, such as the suture 2812 shown in FIGS. 28B-28E, without disrupting the hemostasis of the system or relying on a scalpel or other cutting method to cut the suture. Specifically, FIG. 30A illustrates an unused position in which a cutting actuator 3002 is attached to a blade 3004 and a suture removal actuator 3006 is attached to a loop 3008 or hook attached to the suture 2812. FIG. 30B illustrates cutting the suture 2812 by applying pressure on the cutting actuator 3002 to sever the suture 2812. FIG. 30C illustrates removal of the suture by removing the suture removal actuator 3006, which uses the loop 3008 to carry the suture 2812 out of the delivery device.

[0323] Packaging for the delivery system As discussed above, many embodiments utilize a coating, lubricious coating, and / or hydrophilic coating, such as a hydrogel, on a smooth sleeve covering the docking device. In some embodiments, the docking device itself may have a coating. After manufacture, the docking device and delivery system are transported for use. During transportation or storage, the environment may change over time, such as with different weather patterns and / or geographic locations. These environments may include changes in humidity. However, many hydrophilic coatings may absorb moisture in the environment. As the delivery device is transported or stored, the hydrophilic coating may experience one or more wet-dry cycles. The wet-dry cycles may cause the hydrophilic coatings of adjacent coils to stick together. Other coatings may also promote adjacent coils to stick together. Coils that stick together may be problematic when preparing the docking device for use or when loading the docking device into a delivery system. Certain embodiments of the present invention are thereby directed to packaging for the delivery systems and docking devices as discussed herein.

[0324] 31A and 31B, various embodiments of a coil holder 3100 are shown. As seen in FIG. 31A, a series of fins 3102 protrude from a central post 3104. In many embodiments, the fins 3102 separate the individual turns or coils of a docking device or sleeved docking device. Separating the individual coils or turns from one another prevents the coils from sticking together, even when subjected to wet-dry cycles during storage, shipping, or otherwise. In various embodiments, adjacent fins 3102 are separated by a distance sufficient to allow a single turn of a sleeved docking device to be positioned between them. Additionally, many embodiments of the coil holder 3100 include a central opening 3106 formed in the central post 3104. In some embodiments, the central opening 3106 can be used to attach the coil holder 3100 to an outer package, which may have a complementary protrusion for mounting the coil holder 3100 using the central opening 3106. In some embodiments, the coil holder 3100 includes a central opening having an irregular shape, such as a circle with wings, as shown in Figure 31B, or other features that prevent the coil holder 3100 from rotating in the outer package. Additionally, the coil holder 3100 may be made from any material suitable for maintaining separation of the individual coils and preventing the coils from sticking or clumping together, including plastics and polymers, such as acetal homopolymer.

[0325] When loaded into the outer package, the coil holder 3100 can be located in a low position or in a receptacle formed in the outer package. In some embodiments, the packaging, positioning, and alignment of the coil holder 3100 is configured such that preparation and loading of the sleeved docking device (e.g., retracting the sleeve and docking device into the outer catheter or outer sheath of the delivery system) can be performed without removing the delivery device from the outer package or while the delivery device is in its packaged position.

[0326] method The present disclosure provides a method for delivering an implant to a native valve of the heart. The method can be used to deliver any of the implants described herein, including docking devices having aspects shown in non-limiting Figures 7A-16 and further described elsewhere herein. The method can include positioning a selected docking device on a native valve of the heart such that at least a portion of the leading turns of the docking device are positioned around one or more leaflets of the native valve in a ventricle of the heart. In some implementations, implantation of the docking device can act to reshape one or more tissues in the heart to restore function of the native valve. In certain implementations, the method can include delivering a docking device to a native mitral valve to restore left ventricle function in the heart. In further implementations, the method can reduce the diameter of the valve annulus and apply tension to the chordae. In still further implementations, the method may further include performing an edge-to-edge repair on the native leaflets of the native valve, such as by applying a clip to attach the free edge of the anterior mitral leaflet to the free edge of the posterior mitral leaflet.

[0327] In some implementations, the method may include delivering an implantable prosthetic heart valve into the docking device after the docking device is positioned on the heart's native valve at a desired location. The method may be used to deliver any of the implantable prosthetic heart valves described herein, including valves having aspects shown in non-limiting Figures 3A-6 and further described elsewhere herein. In some implementations, a suitable implantable prosthetic heart valve that may be used in the method includes an annular frame with an inflow end and an outflow end that is radially collapsible and expandable between a radially collapsed configuration and a radially expanded configuration, the annular frame defining an axial direction extending from the inflow end to the outflow end, a leaflet structure positioned within the frame and secured to the frame, and a flange configured to be attached to the inflow end of the annular frame and extend outward from the inflow end. In certain implementations, the method may further include the steps of positioning the implantable prosthetic heart valve in a radially collapsed configuration within the docking device, and expanding the implantable prosthetic heart valve from the radially collapsed configuration to a radially expanded configuration such that a radially outward pressure is applied by the frame of the implantable prosthetic heart valve to at least a portion of a central region of the docking device.

[0328] In some embodiments, the present disclosure further provides a method of delivering a docking device using a delivery system described anywhere herein, including delivery systems having the embodiments shown in non-limiting Figures 17-29E and 33-38. In certain implementations, a delivery system suitable for use in the method may include a delivery catheter, a docking device having end portions at the ends of the stabilizing windings positioned opposite a central region, a pushing shaft disposed in the delivery catheter and coupled to the end portion of the docking device, and a sleeve shaft positioned coaxially with the pushing shaft and disposed between the delivery catheter and the pushing shaft. In some implementations, the delivery system may be configured such that the pushing shaft and sleeve shaft operate in parallel. In certain implementations, the positioning step of the method may include pushing the docking device from the catheter with the pushing shaft. In some implementations, the positioning step of the method may include using a pushing member to hold the docking device in place while the sleeve and / or catheter are retracted from the docking device.

[0329] FIG. 39 shows a flow chart of a method 3300 for delivering a docking device to a native valve of a heart and implanting the docking device and associated prosthetic heart valve in the native valve. The method 3300 can start at 3302 and include advancing a distal end portion of a delivery system to a native valve of a patient's heart, the delivery system configured to deliver and implant a docking device disposed within the distal end portion and covered by a distal section of a sleeve shaft of the delivery system. The delivery system can be one of the delivery systems described herein, including the delivery system components described above with reference to FIGS. 17A-29E. The docking device can include a coil extending along a central axis and including a central region including a plurality of turns, a leading turn extending from a first end of the central region, and a stabilizing turn extending from a second end opposite the central region, wherein the covering extends around and along the overturn of the central region, the overturn being disposed at the second end of the central region. For example, in some embodiments, the docking device can be one of the docking devices described herein with reference to FIGS. 9A-12E. Additionally, in some embodiments, the covering that extends along around the upper turns of the central region may be covering portion 100 shown in Figure 12E. In some embodiments, the native valve may be the mitral valve of the heart.

[0330] At 3304, the method 3300 can include deploying a docking device from the distal end of the delivery system, the docking device covered by a distal section of a sleeve shaft of the delivery system. As described herein with reference to FIGS. 17A-29E and 33-37, deploying the docking device can include pushing the covered docking device over the outer shaft of the delivery system with a pusher shaft of the delivery system. For example, pushing the docking device over the outer shaft with the pusher shaft can include actuating the pusher shaft to extend distally (axially) out of the outer shaft of the delivery system in response to a user moving the hub assembly and / or handle assembly in a distal direction. As a result, both the pusher shaft and the sleeve shaft can move axially together, distally out of the outer shaft.

[0331] The method at 3304 may further include positioning the coated docking device on a native valve (e.g., mitral valve 10 shown in FIGS. 1 and 2) such that the coating of the upper turns of the central region crosses and occludes the midcomissure of the native valve (e.g., the lower right commissure 24 shown in FIG. 2), at least a portion of the leading turns is positioned in a ventricle of the heart (e.g., the left ventricle 14 shown in FIG. 1), and at least a portion of the stabilizing turns is positioned in an atrium of the heart (e.g., the left atrium 12 shown in FIG. 1).

[0332] During advancement, deployment, and positioning of the covered docking device, as previously introduced and shown in Figures 33 and 17B, the distal tip of the distal section of the sleeve shaft can extend distally of (e.g., beyond) the distal end of the docking device, thereby providing the distal section of the sleeve with a more atraumatic tip that can deform and bend when maneuvering around native anatomy.

[0333] The method at 3306 may include flushing one or more lumens of the delivery system during deployment. The one or more lumens may include a first lumen disposed between the 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 FIG.

[0334] In some embodiments, flushing the first lumen can include providing flushing fluid to a pusher shaft lumen extending through the pusher shaft from a proximal end of the pusher shaft disposed in the bifurcation section of the hub assembly to which the suture lock is coupled to a distal end of the pusher shaft, the distal end being disposed adjacent to but spaced from the proximal end of the docking device. Flushing the first lumen can further include flowing flushing fluid through the pusher shaft lumen and into and through the first lumen. In some embodiments, the flushing fluid can be provided to the pusher shaft lumen through a flushing port coupled to the bifurcation section distal to the suture lock. In alternative embodiments, the flushing fluid can be provided to the pusher shaft lumen through a flushing port that is part of the suture lock and disposed at the proximal end of the suture lock.

[0335] In some embodiments, flushing the second lumen may include providing a flushing fluid to a first cavity (e.g., cavity 2254 shown in FIG. 36 ) formed between the outer surface of the pusher shaft and the inner surface of the conduit in the bifurcation area, flowing the flushing fluid from the first cavity to a second cavity (e.g., cavity 1946 shown in FIG. 37 ) formed between the outer shell of the pusher shaft and the sleeve shaft, and flowing the flushing fluid from the second cavity to the second lumen.

[0336] In some embodiments, flushing the lumen of the delivery device as described above may additionally be performed while preparing the delivery device for the implantation procedure, prior to inserting the delivery device into the patient.

[0337] At 3308, the method 3300 may include, after positioning the covered docking device, retracting the sleeve shaft proximally to uncover the docking device. In some embodiments, retracting the sleeve shaft to uncover the docking device may include proximally moving a sleeve actuation handle of the delivery system. The method at 3308 may further include maintaining a position of the pusher shaft while retracting the sleeve shaft to uncover the docking device, and after uncovering the docking device, retracting the pusher shaft back onto the outer shaft of the delivery system.

[0338] The method 3300 can continue at 3310 to release (e.g., uncouple) the docking device from the delivery system. As described herein, the delivery system may include a suture lock assembly (e.g., suture lock 2206 of FIG. 24A and / or suture lock 2700 of FIGS. 27A-29E) that includes a suture cut location for severing a suture (or other retrieval line) that extends from the suture lock through the delivery system and loops around the end of the docking device. In some embodiments, as described above with reference to FIGS. 27A-30C, the method at 3310 may include exposing the suture cut location of the suture lock and using a cutting mechanism (such as the mechanism shown in FIGS. 30A-30C) to cut the suture and then pull the suture away from the docking device. As a result, the docking device may be uncoupled from the delivery system.

[0339] At 3312, the method 3300 may include deploying a prosthetic heart valve (e.g., one of the valves shown in Figures 3A-8) within the implanted docking device as described herein.

[0340] A method of delivering a docking device according to certain embodiments is shown in Figures 32A-32C. Figure 32A illustrates delivery of a docking device including a covering 100. Specifically, Figure 32A illustrates initial retraction of the sleeve or distal section into the delivery device. However, the covering 100 is not fully expanded and extends over a portion of the pusher shaft 1900. Accordingly, Figure 32B illustrates partial reinsertion of the sleeve or distal section 1502 to push the covering 100 into its expanded configuration, and Figure 32C illustrates complete retraction of the sleeve or distal section into the delivery device with the covering 100 in its expanded configuration and no longer covering the pusher shaft 1900.

[0341] Additional steps described elsewhere herein may be added, and the systems and assemblies described herein may be used in these methods. Any and all of the methods, acts, and steps described herein may be performed in a living animal or a non-living cadaver, a cadaver heart, a simulator (e.g., a simulated body part, tissue, etc.), an anthropomorphic skeleton, etc.

[0342] General Considerations For purposes of this description, certain aspects, advantages, and novel features of the disclosed embodiments are described herein. The disclosed methods, devices, and systems should not be construed as limiting in any way. Instead, the present disclosure is directed to all novel and non-obvious features and aspects of the various disclosed embodiments, both alone and in various combinations and subcombinations with one another. The methods, devices, and systems are not limited to those particular aspects, features, or combinations, and the disclosed embodiments do not require that one or more particular advantages exist or problems be solved.

[0343] Although some operations of the disclosed embodiments are described in a particular sequential order for convenient presentation, it should be understood that the description of this methodology encompasses rearrangements unless a particular order is required by explicit language subsequently stated. For example, operations described in sequence may, in some cases, be rearranged or performed in parallel. Moreover, for simplicity, the accompanying figures may not show the various ways in which the disclosed methods can be used in combination with other methods. Also, the description may use terms such as "provide" or "achieve" to describe the disclosed methods. These terms are high-level abstractions of the actual operations that are performed. The actual operations corresponding to these terms may vary depending on the particular implementation and are readily discernible by those skilled in the art.

[0344] As used in this application and in the claims, the singular forms "a," "an," and "the" include the plural unless the context clearly dictates otherwise. Also, the term "comprises" means "comprising." Furthermore, the terms "coupled" and "associated" generally mean electrically, electromagnetically, and / or physically (e.g., mechanically or chemically) coupled or connected and do not exclude the presence of intermediate elements between coupled or associated items unless specifically stated to the contrary.

[0345] In the context of this application, the terms "lower" and "upper" are used interchangeably with the terms "inflow" and "outflow," respectively. Thus, for example, the lower end of a valve is its inflow end and the upper end of a valve is its outflow end.

[0346] As used herein with reference 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 the user and / or closer to the handle of a delivery system that is positioned outside the patient and away from the implantation site. As used herein, the term "distal" refers to a position, direction, or portion of a device that is farther away from the user and / or the handle of a delivery system and closer to the implantation site. Thus, for example, proximal movement of a device is movement of the device toward the user, and distal movement of a device is movement of the device away from the user. The terms "longitudinal" and "axial," unless expressly defined otherwise, refer to axes extending in the proximal and distal directions. Additionally, the term "radial" refers to a direction that is positioned along a radius from the center of an object and perpendicular to an axis and point (the axis being centrally located, such as the central longitudinal axis of a delivery system).

[0347] In view of the many possible embodiments to which the principles of the disclosed technology may be applied, it should be recognized that the illustrated embodiments are merely preferred examples and should not be taken as limiting the scope of the present disclosure. Rather, the scope of the present invention is at least as broad as the following claims. The subject matter of the present invention is also provided by the following clauses. [Section 1] 1. A suture locking assembly for a delivery system for an implantable medical device, comprising: a spool configured to receive a suture and including a gear; a rotatable handle coupled to the spool and configured to rotate the spool and the gear; a pawl configured to engage teeth of the gear and permit rotation of the gear, the spool, and the handle in only one direction; a direction selection device 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 direction selection device configured to adjust the orientation of the pawl relative to the gear and pivot the pawl to adjust the direction of rotation of the gear; and 1. A suture locking assembly comprising: [Section 2] Item 1. The suture locking assembly of item 1, wherein the pawl is pivotable between a first orientation that allows rotation of the gear only in a first direction and a second orientation that allows rotation of the gear only in an opposite second direction. [Section 3] Item 3. The suture locking assembly of item 2, wherein the first direction is counterclockwise and the second direction is clockwise. [Section 4] 4. The suture locking assembly according to claim 2 or 3, wherein the claw is held in the first orientation and the second orientation by a spring plunger that is engaged with the claw on a back side of the claw, and in the first orientation, the claw is positioned on a first side of the spring plunger, and in the second orientation, the claw is positioned on a second side of the spring plunger. [Section 5] Item 5. The suture locking assembly of item 4, wherein the pawl has two teeth spaced apart from each other and positioned on a front side of the pawl, and the two teeth of the pawl are configured to engage with the teeth of the gear. [Section 6] 6. The suture locking assembly of any one of claims 1 to 5, further comprising hard stops disposed within a housing of the suture locking assembly, wherein the gear and the pawl are disposed within the housing, and the pawl is configured to interface with one of the hard stops when the gear is rotated in a direction opposite to the selected direction of rotation set by the direction selection device. [Section 7] 7. The suture locking assembly of any one of claims 1 to 6, further comprising a housing having an upper housing and a lower housing coupled to each other, wherein the gear and the pawl are disposed in a space disposed between the upper housing and the lower housing, the rotatable handle and the direction selection device extend outward from the upper housing, the upper housing comprises a first icon indicating a loose position of the direction selection device and a second icon indicating a tensioned position of the direction selection device, and the direction selection device is movable between a first of the two positions pointing toward the first icon and a second of the two positions pointing toward the second icon. [Section 8] 8. The suture locking assembly of any one of claims 1 to 7, further comprising a release bar having a suture cutting location disposed at a distal end thereof, the release bar configured to receive a suture through an interior of the release bar and across the suture cutting location, the suture extending from the spool. [Section 9] Item 9. The suture locking assembly of item 8, wherein the release bar comprises one or more support members disposed in a central portion of the release bar, the central portion being disposed between the distal end and the proximal end of the release bar. [Section 10] 10. The suture locking assembly of claim 8 or 9, wherein a distal end of the release bar is shaped to form a first keyed connection with an adapter of the delivery system, a proximal end of the release bar is shaped to form a second keyed connection with a lower housing of the suture locking assembly, and the spool is disposed within the interior of the lower housing. [Section 11] Item 11. The suture locking assembly of item 10, further comprising an irrigation port coupled to the lower housing and extending outward from the lower housing in a direction opposite to the direction in which the release bar extends from the lower housing. [Section 12] 12. The suture locking assembly of any one of claims 8 to 11, further comprising a plurality of annular sealing elements including a first annular sealing element disposed around a distal end portion of the release bar and a second annular sealing element disposed around a proximal end portion of the release bar adjacent to the suture cutting position, wherein the second annular sealing element is disposed radially between the release bar and a lower housing of the suture locking assembly, and the spool is disposed within the lower housing. [Section 13] Item 13. The suture locking assembly of item 12, wherein the plurality of annular sealing elements further comprises a third annular sealing element disposed around a portion of the spool and between the portion of the spool and the lower housing. [Section 14] Item 14. The suture locking assembly of any one of items 8 to 13, wherein the proximal end of the release bar is adhered to the lower housing of the suture locking assembly. [Section 15] 15. The suture locking assembly of any one of claims 8 to 14, wherein the release bar includes a divider disposed within the suture cutting position, the divider configured to separate two lines of suture extending longitudinally through the release bar and expose only one of the two lines of suture to the outside of the suture locking assembly at the suture cutting position. [Section 16] Item 16. The suture locking assembly of any one of items 1 to 15, wherein the spool includes a gap in a flange positioned around a bottom of the spool, and the rotatable handle includes an indicator on an outer surface configured to track the number of turns applied to the spool and to position the gap. [Section 17] Item 17. The suture locking assembly of item 16, wherein the gap is positioned adjacent to one or more openings positioned within the spool, the one or more openings configured to route the suture from an interior of the spool to an exterior surface of the spool configured to receive the suture. [Section 18] Item 18. The suture locking assembly of any one of items 1 to 17, wherein the rotatable handle is coupled to the spool via a central screw extending longitudinally through the rotatable handle and the spool, and further comprising one or more friction pads disposed around the central screw adjacent 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 configured to increase friction on the central screw to stop rotation of the central screw and the rotatable handle when tension on the suture increases beyond a predetermined threshold. [Section 19] 18. The suture lock assembly of any one of claims 1 to 17, further comprising a pin-based clutch system including a spring plunger extending longitudinally through a portion of the rotatable handle and coupled to the portion of the rotatable handle, the spring plunger having an end extending into the gear and configured to extend into and mate with a plurality of detents located on an outward surface of the gear to allow rotation of the gear by the rotatable handle, the spring plunger configured to slide out of the detents in response to a tension on the suture exceeding a predetermined threshold. [Section 20] 1. A delivery system for delivering a docking device to a native valve annulus of a patient's heart, comprising: An outer shaft; a sleeve shaft at least partially disposed within the outer shaft, a distal section configured to cover the docking device and including a flexible material with a smooth outer surface; and a proximal section comprising a rigid material and having a tubular portion and a cutting portion, the cutting portion having an open U-shaped cross section; a sleeve shaft comprising: a pusher shaft disposed at least partially within the outer shaft, a main tube disposed radially within the sleeve shaft relative to a central longitudinal axis of the delivery system; an annular outer shell surrounding a proximal end portion of the main pipe and spaced apart from an outer surface of the main pipe in the radial direction; and a proximal extension coupled to the proximal end of the main tube proximally of the outer shell and extending proximally from the proximal end of the main tube, the proximal extension comprising a flexible material and extending along a portion of an inner surface of the cutting portion of the proximal section of the sleeve shaft; a push-in shaft comprising: A delivery system comprising: [Section 21] 21. The delivery system of claim 20, wherein the pusher shaft further comprises an annular plug disposed within the annular outer shell at the proximal end of the outer shell and surrounding the main tube, the plug having a crescent-shaped portion extending across and filling a first portion of the annular space disposed between the main tube and the outer shell. [Section 22] 22. The delivery system of claim 21, wherein the annular space is open and has a second portion that is not filled by the plug, the proximal section of the sleeve shaft is configured to slide within the annular space, and the cut portion of the proximal section is configured to slide through the second portion of the annular space. [Section 23] 23. The delivery system of claim 22, wherein the tubular portion of the proximal section has an end face at the interface between the tubular portion and the cutting portion, the end face being disposed perpendicular to the central longitudinal axis, and the plug is configured to connect at the interface with the end face of the proximal section and stop the sleeve shaft from advancing further axially proximally. [Section 24] 24. The delivery system of any one of paragraphs 20 to 23, wherein the sleeve shaft further comprises an intermediate section disposed between the distal section and the proximal section of the sleeve shaft, the intermediate section forming a transition between the flexible material of the distal section and the rigid material of the proximal section. [Section 25] Item 25. The delivery system of item 24, wherein the sleeve shaft further comprises a flexible polymer jacket forming the outer surface of the distal section and the intermediate section, the flexible polymer jacket comprising the flexible material, an inner liner forming the inner surface of each of the distal section and the intermediate section, and a rigid tube including a first section forming the entire proximal section and a second section forming a proximal portion of the intermediate section. [Section 26] Item 26. The delivery system of item 25, wherein the rigid tube is a metal tube, the second section has a plurality of openings arranged around the circumference of the rigid tube along the second section, and the rigid tube is bonded to the inner liner and the flexible polymer jacket through the plurality of openings via an adhesive connection between the inner liner and the flexible polymer jacket. [Section 27] 27. The delivery system of any one of paragraphs 20 to 26, further comprising a handle assembly comprising a handle portion and a hub assembly extending proximally from a proximal end of the handle portion, the outer shaft extending distally from a distal end of the handle portion, and the hub assembly comprising an adapter with a straight section coupled to a suture locking assembly and a branched section coupled to a sleeve actuation handle. [Section 28] Item 27. The delivery system of item 27, wherein the suture locking assembly is any one of the suture locking assemblies of items 1 to 19. [Section 29] 29. The delivery system of claim 27 or 28, wherein the proximal extension of the pusher shaft extends into and through a portion of the branch section of the adapter. [Section 30] 30. The delivery system of claim 29, further comprising a first flushing port coupled to the branch section of the adapter and fluidly coupled to the internal lumen of the proximal extension of the pusher shaft. [Section 31] 31. The delivery system of claim 30, further comprising a second flushing port coupled to the branch section distal to the first flushing port and fluidly coupled to a lumen formed between the outer surface of the proximal extension and the inner surface of the branch section. [Section 32] 30. The delivery system of claim 29, further comprising: a first flushing port coupled to the proximal end of the suture locking assembly and fluidly coupled to the internal lumen of the proximal extension of the pusher shaft; and a second flushing port coupled to the branch section distal to the first flushing port and fluidly coupled to a lumen formed between the outer surface of the proximal extension and the inner surface of the branch section. [Section 33] 33. The delivery system of any one of paragraphs 27 to 32, wherein the cutting portion of the sleeve shaft extends into the straight section of the adapter and is coupled to the sleeve actuation handle. [Section 34] 34. The delivery system of any one of claims 20 to 33, wherein the pusher shaft and the sleeve shaft are coaxial with each other along the central longitudinal axis of the delivery system, and each of the sleeve shaft and the pusher shaft is configured to slide axially along the central longitudinal axis relative to the outer shaft. [Section 35] 35. The delivery system of any one of paragraphs 20 to 34, wherein the distal section of the main tube of the pusher shaft includes a plurality of cuts spaced apart from one another along the length of the distal section, the plurality of cuts configured to increase the flexibility of the distal section of the main tube. [Section 36] Item 36. The delivery system of item 35, wherein the spacing between adjacent cuts among the plurality of cuts varies along the length of the distal section, the spacing between adjacent cuts increasing from the distal end to the proximal end of the distal section. [Section 37] 1. A delivery system for delivering a docking device to a native valve annulus of a patient's heart, comprising: The handle and an outer shaft extending distally from a distal end of the handle portion; a sleeve shaft extending through the outer shaft and configured to cover the docking device; a pusher shaft having a main tube extending through the interior of the sleeve shaft; a hub assembly extending proximally from the proximal end of the handle portion, an adapter coupled to the handle portion and including a first section and a second section branching from the first section, a portion of the pusher shaft extending into the second section and a proximal section of the sleeve shaft extending through the first section; a suture locking assembly coupled to a proximal end of the second section and configured to adjust tension on a suture extending therefrom, through the pusher shaft, and into the docking device; a first flushing port coupled to the second section and fluidly coupled to a first fluid flow lumen disposed within the pusher shaft and a second fluid flow lumen disposed between the sleeve shaft and the docking device; and a second flushing port coupled to the second section and fluidly coupled to a third fluid flow lumen disposed between the outer shaft and the sleeve shaft; a hub assembly comprising: A delivery system comprising: [Section 38] Item 38. The delivery system of item 37, further comprising a sleeve actuation handle positioned at the proximal end of the first section and coupled to the end of the proximal section of the sleeve shaft, the sleeve actuation handle configured to adjust the axial position of the sleeve shaft relative to the outer shaft. [Section 39] 39. The delivery system of claim 37 or 38, wherein the first fluid flow lumen extends through the interior of a proximal extension of the pusher shaft and the interior of the main tube of the pusher shaft, the main tube being coupled to the proximal extension and extending through the interior of the outer shaft, and the proximal extension extending through a portion of the outer shaft to the second section. [Section 40] 40. The delivery system of claim 39, wherein the first fluid flow lumen extends to a distal end of the pusher shaft, the distal end being positioned adjacent to but spaced apart from a proximal end of the docking device when the docking device is positioned within the outer shaft. [Section 41] 41. The delivery system of claim 39 or 40, wherein the second flushing port is fluidly coupled to the third fluid flow lumen via an annular cavity disposed between the outer shell of the pusher shaft and the main tube of the pusher shaft, and a fourth fluid flow lumen formed between the outer surface of the proximal extension and the inner surface of the second section, and the fourth fluid flow lumen is fluidly coupled to the annular cavity. [Section 42] Item 42. The delivery system of item 41, wherein the third fluid flow lumen is disposed between the inner surface of the outer shaft and the distal portion of the sleeve shaft, the distal portion being configured to cover the docking device while the docking device is disposed inside the outer shaft and implanted in the native valve annulus. [Section 43] 43. The delivery system of claim 41 or 42, further comprising a third flushing port coupled to the handle portion and fluidly coupled to the annular cavity. [Section 44] 44. The delivery system of any one of paragraphs 37 to 43, further comprising a gasket disposed within and spanning the diameter of the second section between where the first flushing port is coupled to the second section and where the second flushing port is coupled to the second section, the gasket configured to fluidly separate the first fluid flow lumen and the third fluid flow lumen from each other. [Section 45] 45. The delivery system of any one of paragraphs 37 to 44, wherein the first flushing port and the second flushing port are connected to a single fluid source. [Section 46] 46. ​​The delivery system of claim 45, wherein the single fluid source is an infusion pump, and the infusion pump is coupled to the first flushing port and the second flushing port via a Y-connector. [Section 47] 45. The delivery system of any one of paragraphs 37 to 44, wherein the first flushing port and the second flushing port are connected to different fluid sources. [Section 48] 48. The delivery system of any one of paragraphs 37 to 47, wherein the first flushing port is directly coupled to the second section of the adapter distal to the suture locking assembly and proximal to the second flushing port. [Section 49] 48. The delivery system of any one of paragraphs 37 to 47, wherein the first flushing port is part of the suture locking assembly and is located at the proximal end of the suture locking assembly. [Section 50] 50. The delivery system of any one of clauses 37 to 49, further comprising a hemostatic seal positioned within the first section of the adapter adjacent to the sleeve actuation handle, the hemostatic seal having an opening surrounding a cut portion of the sleeve shaft extending through the first section to the sleeve actuation handle, and the hemostatic seal configured to seal around the cut portion of the sleeve shaft. [Section 51] Item 51. The delivery system of item 50, further comprising a locking cap assembly positioned around the hemostatic seal in the first region, the locking cap assembly configured to apply inward pressure to the hemostatic seal and lock axial translation of the sleeve shaft relative to the remainder of the hub assembly. [Section 52] 52. The delivery system of any one of claims 37 to 51, wherein the suture locking assembly is any one of the suture locking assemblies of claims 1 to 19. [Section 53] 53. The delivery system of any one of paragraphs 37 to 52, wherein the pushing shaft is configured to deploy the docking device from inside the distal end portion of the outer shaft upon reaching the native valve annulus, and the distal end of the sleeve sha...

Claims

1. A delivery system for delivering a docking device to the original valve annulus of a patient's heart, The handle part, An outer shaft extending distally from the distal end of the handle portion, A sleeve shaft extending through the interior of the outer shaft and configured to cover the docking device, A push shaft having a main tube extending through the inside of the sleeve shaft, A hub assembly extending proximal to the proximal end of the aforementioned handle portion, An adapter coupled to the handle portion, comprising a first region and a second region branching from the first region, wherein a portion of the push shaft extends into the second region and the proximal region of the sleeve shaft extends through the first region, A suture locking assembly, coupled to the proximal end of the second area and configured to adjust the tension in the suture extending from itself through the push shaft to the docking device, A first fluid flow lumen is coupled to the second area and located inside the push shaft, and a first cleaning port is fluid-coupled to the second fluid flow lumen located between the sleeve shaft and the docking device. A hub assembly equipped with A delivery system equipped with the following features.

2. The delivery system according to claim 1, wherein the hub assembly is further coupled to the second area and is fluidly coupled to a third fluid flow lumen located between the outer shaft and the sleeve shaft.

3. The delivery system according to claim 1 or 2, further comprising a sleeve operating handle positioned at the proximal end of the first area and coupled to the end of the proximal area of ​​the sleeve shaft, the sleeve operating handle configured to adjust the axial position of the sleeve shaft with respect to the outer shaft.

4. The delivery system according to any one of claims 1 to 3, wherein the first fluid flow lumen extends through the interior of the proximal extension of the push shaft and through the interior of the main tube of the push shaft, the main tube is connected to the proximal extension and extends through the interior of the outer shaft, and the proximal extension extends through a portion of the outer shaft to the second area.

5. The delivery system according to claim 4, wherein the first fluid flow lumen extends to the distal end of the push shaft, the distal end being positioned adjacent to the proximal end of the docking device but spaced apart from the proximal end when the docking device is positioned within the outer shaft.

6. The delivery system according to claim 4 or 5, as referenced to claim 2, wherein the second cleaning port is fluidly coupled to the third fluid flow lumen via an annular cavity disposed between the outer shell of the push shaft and the main tube of the push shaft, and a fourth fluid flow lumen formed between the outer surface of the proximal extension and the inner surface of the second area, and the fourth fluid flow lumen is fluidly coupled to the annular cavity.

7. The delivery system according to claim 6, wherein the third fluid flow lumen is located between the inner surface of the outer shaft and the distal portion of the sleeve shaft, the distal portion being configured to cover the docking device, which is located inside the outer shaft and embedded in the original valve ring.

8. The delivery system according to claim 6 or 7, further comprising a third cleaning port coupled to the handle portion and fluidly coupled to the annular cavity.

9. The delivery system according to claim 2 and any one of claims 3 to 8 as referenced from claim 2, further comprising a gasket positioned over the diameter of the second area between the location where the first cleaning port is coupled to the second area and the location where the second cleaning port is coupled to the second area, wherein the gasket is configured to fluidly separate the first fluid flow lumen and the third fluid flow lumen from each other.

10. The delivery system according to claim 2 and any one of claims 3 to 9 as referenced from claim 2, wherein the first cleaning port and the second cleaning port are connected to a single fluid supply source.

11. The delivery system according to claim 10, wherein the single fluid supply source is an infusion pump, and the infusion pump is coupled to the first and second wash ports via a Y-connector.

12. The delivery system according to claim 2 and any one of claims 3 to 9 as referenced from claim 2, wherein the first cleaning port and the second cleaning port are connected to different fluid supply sources.

13. The delivery system according to claim 2 and any one of claims 3 to 12 as referenced from claim 2, wherein the first cleaning port is coupled distally to the suture locking assembly and proximal to the second cleaning port to the second area of ​​the adapter.

14. The delivery system according to any one of claims 1 to 12, wherein the first cleaning port is part of the suture locking assembly and is located at the proximal end of the suture locking assembly.

15. The delivery system according to claim 3 and any one of claims 4 to 13 as referenced from claim 3, further comprising a hemostatic seal disposed in the first area of ​​the adapter adjacent to the sleeve operating handle, wherein the hemostatic seal has an opening that surrounds a cut portion of the sleeve shaft extending through the first area to the sleeve operating handle, and the hemostatic seal is configured to seal around the cut portion of the sleeve shaft.

16. The delivery system according to claim 15, further comprising a locking cap assembly positioned in the first area around the hemostatic seal, configured to apply inward pressure to the hemostatic seal and to lock the axial translation of the sleeve shaft relative to the rest of the hub assembly.

17. The delivery system according to any one of claims 1 to 16, wherein the push shaft is configured to deploy the docking device from the inside of the distal end portion of the outer shaft when it reaches the original valve ring, the distal end of the sleeve shaft is separated from the distal end of the outer shaft within the outer shaft, while the docking device is positioned within the outer shaft while guiding the delivery system to the original valve ring.

18. The delivery system according to any one of claims 1 to 17, wherein the docking device is configured to receive a prosthetic heart valve and fix it in the original valve annulus.

Images