SYSTEMS, DEVICES AND METHODS FOR TREATING HEART VALVES
Patent Information
- Application Number
- MX2021014283
- Authority / Receiving Office
- MX · MX
- Patent Type
- Patents
- Current Assignee / Owner
- Priority Date
- 2019-09-30
- Filing Date
- 2021-11-22
- Publication Date
- 2026-02-25
- Estimated Expiration
- 2040-06-08
AI Technical Summary
Existing transcatheter heart valve replacement technologies face challenges in securely anchoring prosthetic valves in non-circular valve annuli, such as the mitral valve, due to anatomical variations and high cyclic loads, leading to paravalvular leaks and instability.
The development of anchoring or docking devices that are designed to fit and secure prosthetic valves in various valve annuli, including those with non-circular cross sections, by using coupling devices with coiled shapes and expandable materials that stabilize the prosthetic valve and reduce paravalvular leaks.
These devices provide secure anchoring and reduce paravalvular leaks by maintaining the prosthetic valve in the correct position, even under high cyclic loads, enhancing the effectiveness and longevity of transcatheter mitral valve replacement.
Smart Images

Figure MX431193B0
Abstract
Description
The present invention relates to systems and methods for treating valve regurgitation and / or other valve problems. Background of the Invention Prosthetic heart valves may be used to treat heart valve disorders. The native heart valves (the aortic, pulmonary, tricuspid, and mitral valves) serve critical functions in ensuring the direct flow of an adequate blood supply through the cardiovascular system. These heart valves can become less effective due to congenital, inflammatory, infectious, and other conditions. Over time, these conditions can lead to serious cardiovascular compromise or death. A transcatheter technique can be used to introduce and implant a prosthetic heart valve using a flexible catheter in a way that is less invasive than open heart surgery. In this technique, a prosthetic valve can be mounted in a folded state on the end of a flexible catheter and advanced through a patient's blood vessel until the valve reaches the implantation site. The valve at the distal end of the catheter can then Ref. 328159 expand to its functional size at the site of the defective native valve, such as by inflating a balloon where the valve is mounted. Alternatively, the valve may have an elastic self-expanding stent or framework that expands the valve to its functional size when advanced from a delivery sheath at the distal end of the catheter. Optionally, the valve may have a mechanically expanded frame, or the valve may have a combination of expansion mechanism, such as glooly, self-expanding, and / or mechanically expanding portions. Transcatheter heart valves (THVs) could theoretically be of an appropriate size or shape to be placed within the native mitral and tricuspid valves. However, the anatomy of the mitral and tricuspid valves can vary significantly from person to person and it can be difficult to properly size and shape a valve for many patients. Additionally, when valvular insufficiency is treated, the surrounding tissue may not be strong enough to hold certain types of valves in the desired position. It would be beneficial to have a docking system and / or apparatus to secure the prosthetic valves in the proper position and appropriate delivery systems to ensure safe and effective administration. Additionally, the shape of the native valve may allow paravalvular leakage around the prosthetic valve (i.e., blood flow bypassing the prosthetic valve). Thus, solutions to increase the efficiency of prosthetic valve placement and reduce paravalvular leak would be beneficial. Brief Description of the Invention This brief description is intended to provide examples and is not intended to limit the scope of the invention in any way. For example, the claims do not require any feature included in an example of this brief description, unless the claims explicitly mention the feature. The description discloses exemplary embodiments of prosthetic valves, docking stations for prosthetic valves, delivery devices for docking stations, and packaging for delivery devices. Docking stations, catheters and handles can be constructed in a variety of ways. Furthermore, the described features can be combined in various ways. Various features and steps may be included as described elsewhere in this description in the examples summarized here. In some embodiments, the systems and / or apparatus herein include a docking device (e.g., an anchor, etc.), a delivery system, a prosthetic or implantable heart valve, a pusher device, other components or combinations. of one or more of these. The coupling device, delivery system, prosthetic valve, etc. They may be the same or similar to those described below or elsewhere in this document. In a representative embodiment, a suture closure assembly for a delivery system for an implantable medical device may include: a spool configured to receive a suture and including a gear; a rotating handle coupled to the reel and configured to rotate the reel and gear; a ratchet configured to engage the teeth of the gear and allow rotation of the gear, spool and handle in a single direction; and a directional selector coupled to the ratchet and movable between two positions, each of the two positions corresponding to a different direction of rotation of the gear, the directional selector configured to pivot the ratchet to adjust an orientation of the ratchet with respect to the gear and adjust the direction of gear rotation. In some embodiments, the ratchet can pivot 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 a second opposite direction. In some embodiments, the first direction is counterclockwise and the second direction is clockwise. In some embodiments, the pawl is held in the first orientation and the second orientation by a spring plunger coupled with the pawl on a rear side of the pawl and wherein, in the first orientation, the pawl is disposed on a first side of the plunger. spring and, in the second orientation, the pawl is disposed on a second side of the spring plunger. In some embodiments, the ratchet includes two teeth spaced apart and disposed on a front side of the ratchet and the two teeth of the ratchet are configured to engage the teeth of the gear. In some embodiments, the suture closure assembly further includes hard stops disposed within a housing of the suture closure assembly, the gear and pawl disposed within the housing, and the pawl is configured to interact with one of the hard stops when the gear rotates in a direction opposite to a selected direction of rotation set by the directional selector. In some embodiments, the suture closure assembly further includes a housing that includes an upper housing and a lower housing engaged together, the gear and pawl disposed within a space disposed between the upper housing and the lower housing. Rotary handle and directional selector can be extended WUUa / 2U21 / Ul 4 20 or outward from the upper casing. The upper housing may include a first icon indicating a directional selector slack position and a second icon indicating a directional selector tension position, and wherein the directional selector is movable between a first of two positions pointing forward. the first icon and a second of the two positions pointing towards the second icon. In some embodiments, a suture closure assembly further includes a release bar that includes a suture cutting location disposed at a distal end of the release bar, the release bar being configured to receive a suture through the interior of the release bar and through the suture cut location, the suture extends from the spool. In some embodiments, the release bar includes one or more support ribs disposed on a central portion of the release bar, the central portion disposed between the distal end and the proximal end of the release bar. In some embodiments, the distal end of the release bar is shaped to form a first keyed connection with an adapter of the delivery system and a proximal end of the release bar is shaped to form a second keyed connection with a lower housing of the assembly. of suture closure, wherein the spool is disposed within the interior of the lower housing. In some embodiments, the suture closure assembly further includes a flush port coupled to the lower housing and extending outwardly from the lower housing in a direction opposite to the direction in which the release bar extends from the housing. lower. In some embodiments, the suture closure assembly further includes a plurality of annular sealing elements, including a first annular sealing element disposed around a distal end portion of the release bar, near the suture cutting location, and a second annular sealing element disposed around a proximal end portion of the release bar, the second annular sealing element disposed between, in a radial direction, the release bar and a lower housing of the suture closure assembly, in where the reel is arranged inside the lower casing. In some embodiments, the plurality of annular sealing elements further includes a third annular sealing element disposed around a portion of the spool and disposed between the spool portion and the lower housing. In some embodiments, a proximal end of the release bar is attached to a lower housing of the suture closure assembly. In some embodiments, the release bar includes a divider disposed within the suture cutting location, wherein the divider is configured to separate two lines of a suture that extend longitudinally through the release bar and expose only one line. of the two suture lines to an outside of the suture closure assembly at the suture cut location. In some embodiments, the spool includes a gap in a flange disposed around the bottom of the spool and the rotating handle includes an indicator on its outer surface configured to track a number of turns applied to the spool and locate the gap. In some embodiments, the space is arranged adjacent to one or more openings disposed within the spool, the one or more openings configured to route the suture from the interior of the spool to an exterior surface of the spool that is configured to receive the suture thereon. . In some embodiments, the rotating handle is coupled to the spool through a central screw that extends longitudinally through the rotating handle and the spool, and the suture closure assembly may further include one or more friction pads disposed around the central screw. , adjacent to the central portion of the spool, and a friction nut coupled to the central screw, below a lower friction pad of one or more friction pads. The one or more friction pads may be configured to increase friction on the central screw to stop rotation of the central screw and rotating handle when the tension in the suture increases above a predetermined threshold. In some embodiments, a suture closure assembly further includes a pin clutch system that includes a spring plunger extending longitudinally through and coupled to a portion of the rotating handle, the spring plunger including an end that extends extends toward the gear and is configured to extend into and engage a plurality of detents disposed on an outwardly facing surface of the gear to permit rotation of the gear by the rotary handle. The spring plunger can be configured to slide out of the retainers in response to tension on the suture above a predetermined threshold. In another representative embodiment, a delivery system for delivering a coupling device to a native valve annulus of a patient's heart may include: an outer shaft and a sleeve shaft disposed at least partially within the outer shaft. The sleeve shaft may include: a distal section configured to cover the coupling device, the distal section including a flexible material with a lubricated outer surface; and a proximal section including a rigid material and including a tubular portion and a cut portion, the cut portion having an open U-shaped cross section. The delivery system may further include a thrust shaft disposed at least partially within the outer shaft, including the thrust shaft: a main tube disposed internally, in a radial direction that is relative to a central longitudinal axis of the delivery system, the sleeve shaft; an annular housing surrounding a proximal end portion of the main tube and separated from, in the radial direction, an outer surface of the main tube; and a proximal extension connected to and extending proximally from a proximal end of the main tube, near the housing, the proximal extension including a flexible material and extending along a portion of an interior surface of the cut portion of the proximal section of the sleeve shaft. In some embodiments, the thrust shaft further comprises an annular plug disposed within the annular frame, at a proximal end of the frame, and surrounding the main shaft, wherein the plug includes a crescent-shaped portion extending across and fills a first portion of an annular space disposed between the main tube and the casing. MA / a / 2U21 / Ul 4203 In some embodiments, the annular space includes a second portion that is open and not filled by the plug, wherein the proximal section of the sleeve shaft is configured to slide within the annular space, and wherein the cut portion of the proximal section is configured to slide through the second portion of the annular space. In some embodiments, the tubular portion of the proximal section has an end surface at an interface between the tubular portion and the cut portion, the end surface disposed perpendicular to the central longitudinal axis, and the plug is configured to interact with the surface of the end of the proximal section and prevent the sleeve axis from moving further in the proximal axial direction. In some embodiments, the sleeve shaft further includes a middle section disposed between the distal section and the proximal section of the sleeve shaft, the middle section forming a transition between the flexible material of the distal section and the rigid material of the proximal section. In some embodiments, the sleeve shaft further includes a flexible polymer jacket that forms an outer surface of the distal section and the middle section, the flexible polymer jacket includes the flexible material, an inner liner that forms an inner surface of each of the distal section and the middle section, and a rigid tube that includes a first section that forms the entire proximal section and a second section that forms a proximal portion of the middle section. In some embodiments, the rigid tube is a metal tube, wherein the second section includes a plurality of openings arranged around a circumference of the rigid tube, along the second section, and wherein the rigid tube is coupled to the liner. interior and the flexible polymer jacket through a bonding connection between the interior liner and the flexible polymer jacket, through the plurality of openings. In some embodiments, the delivery system further includes a handle assembly that includes a handle portion and a hub assembly extending proximally from a proximal end of the handle portion, wherein the outer shaft extends distally from one end. distal of the handle portion, and wherein the hub assembly includes an adapter with a straight section coupled to a suture closure assembly and a branch section coupled to the sleeve drive handle. In some embodiments, the proximal extension of the thrust shaft extends into and through a portion of the branch section of the adapter. In some embodiments, the delivery system further includes a first flush port coupled to the branch section of the adapter and fluidly coupled with an internal lumen of the proximal extension of the thrust shaft. In some embodiments, the delivery system further includes a second rinse port coupled to the branch section, distal to the first rinse port and fluidly coupled with a lumen formed between an outer surface of the proximal extension and an inner surface of the branch section. In some embodiments, the delivery system further includes a first flush port coupled to a proximal end of the suture closure assembly and fluidly coupled with an internal lumen of the proximal extension of the push shaft and a second flush port coupled. to the branch section, distal to the first flush port, and fluidly coupled with a lumen formed between an outer surface of the proximal extension and an inner surface of the branch section. In some embodiments, the cut portion of the sleeve shaft extends into the straight section of the adapter and engages the sleeve drive handle. In some embodiments, the thrust 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 thrust shaft are configured to slide axially along of the central longitudinal axis, with respect to the external axis. In some embodiments, a distal section of the main thrust shaft tube includes a plurality of cuts therein, spaced apart along a length of the distal section, wherein the plurality of cuts is configured to increase a flexibility of the distal section of the main tube. In some embodiments, the spacing between adjacent slices of the plurality of slices varies along the length of the distal section and wherein the spacing between adjacent slices increases from a distal end to a proximal end of the distal section. In another representative embodiment, a delivery system for delivering a coupling device to a native valve annulus of a patient's heart includes: 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 coupling device; a thrust shaft including 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, wherein a portion of the thrust shaft extends toward the second section and a section proximal cuff shaft extends through first section; a suture closure assembly coupled to a proximal end of the second section and configured to adjust tension in a suture extending from the suture closure assembly, through the push shaft, to the engagement device; a first flushing orifice coupled to the second section and fluidly coupled to a first fluid flow lumen disposed within the interior of the thrust shaft and to a second fluid flow lumen disposed between the sleeve shaft and the coupling device ; and a second flush port coupled to the second section and fluidly coupled to a third fluid flow lumen disposed between the outer shaft and the sleeve shaft. In some embodiments, the delivery system further includes a sleeve drive handle disposed at a proximal end of the first section and coupled to an end of the proximal section of the sleeve shaft, the sleeve drive handle configured to adjust a position axial of the sleeve shaft in relation to the outer shaft. In some embodiments, the first fluid flow lumen extends through the interior of a proximal extension of the thrust shaft and an interior of the main tube of the thrust shaft, the main tube coupled to the proximal extension and extending through an inner outer shaft and proximal extension extend through a portion of the outer shaft and into the second section. In some embodiments, the first fluid flow lumen extends to a distal end of the thrust shaft, the distal end disposed adjacent but separate from a proximal end of the coupling device when the coupling device is disposed within the outer shaft. In some embodiments, the second flush port is fluidly coupled to the third fluid flow lumen through an annular cavity disposed between a thrust shaft housing and the main thrust shaft tube, and a fourth flow lumen. of fluid formed between an outer surface of the proximal extension and an inner surface of the second section, the fourth fluid flow lumen fluidly coupled to the annular cavity. In some embodiments, the third fluid flow lumen is disposed between an inner surface of the outer shaft and a distal portion of the sleeve shaft, the distal portion configured to cover the coupling device while the coupling device is disposed within the outer shaft. and is implanted in the native valve annulus. In some embodiments, the delivery system further includes a third rinse port coupled to the handle portion and fluidly coupled to the annular cavity. In some embodiments, the delivery system further includes a gasket disposed within and across a diameter of the second section, between where the first rinse port is coupled to the second section and wherein the second rinse port is coupled to the second. section. The seal is configured to fluidly separate the first fluid flow lumen and the third fluid flow lumen from each other. In some embodiments, the first rinse port and the second rinse port are connected to a single fluid source. In some embodiments, the only source of fluid is an infusion pump and wherein the infusion pump is coupled to the first rinse port and the second rinse port via a Y connector. In some embodiments, the first rinse port and the second rinse port are connected to different fluid sources. In some embodiments, the first flush port is coupled directly to the second section of the adapter, distal to the suture closure assembly and proximate to the second flush port. In some embodiments, the first rinse port WUUa / 2U21 / Ul 4200 is part of the suture closure assembly and is disposed at a proximal end of the suture closure assembly. In some embodiments, the delivery system further includes a hemostatic seal disposed within the first section of the adapter, near the cuff drive handle, wherein the hemostatic seal includes an opening surrounding a cut portion of the cuff shaft that extends through the first sleeve section, to the sleeve drive handle, the hemostatic seal configured to seal around the cut portion of the sleeve shaft. In some embodiments, the delivery system further includes a locking cap assembly disposed in the first section, around the hemostatic seal, the locking cap assembly configured to apply inward pressure on the hemostatic seal and block axial translation of the shaft. of sleeve with respect to the rest of the hub assembly. In some embodiments, the thrust shaft is configured to deploy the coupling device from within a distal end portion of the outer shaft upon reaching the native valve ring and a distal end of the sleeve shaft is spaced from the distal end of the outer shaft. , inside the outer shaft, while the coupling device is arranged inside the outer shaft during navigation of the supply system to the native valve ring. In some embodiments, the coupling device is configured to receive and secure a prosthetic heart valve in the native valve annulus. In a representative embodiment, a method of delivering a coupling device to a native valve of a heart may include: deploying the coupling device from a distal end of a delivery system, the coupling device covered by a distal section of a shaft sleeve of the delivery system, the coupling device including a coil extending along a central axis and including a central region that includes a plurality of turns, an input turn extending from a first end of the central region and a stabilization loop extending from a second opposite end of the central region, wherein a cover extends around and along an upper loop of the central region, the upper loop being arranged at the second end of the central region; placing the covered coupling device on the native valve, such that the cover of the upper loop of the central region crosses and occludes a medial commissure of the native valve, at least a portion of the main loop is placed in a ventricle of the heart , and at least a portion of the stabilization loop is placed in an atrium of the heart; and after placing the covered coupling device, retracting the sleeve shaft, in a proximal direction, to uncover the coupling device. In some embodiments, deploying the coupling device from the distal end of the delivery system includes pushing the covered coupling device off the outer axis of the delivery system with the thrust axis of the delivery system. In some embodiments, retracting the sleeve shaft to uncover the coupling device includes moving the sleeve actuation handle in the proximal direction. In some embodiments, the method may further include maintaining a position of the thrust shaft while retracting the sleeve shaft to uncover the coupling device and, after uncovering the coupling device, retracting the thrust shaft toward the outer shaft of the system. of supply. In some embodiments, the method may further include, during deployment of the covered coupling device and positioning of the covered coupling device on the native valve, flushing a plurality of lumens of the delivery system that includes a first lumen disposed between the section distal of the sleeve shaft and the coupling device and a second lumen disposed between an outer shaft of the delivery system and the sleeve shaft. In some embodiments, flushing the first lumen includes providing flushing fluid to a thrust shaft lumen extending through the thrust shaft from a proximal end of the thrust shaft disposed within a branch section of a hub assembly. , wherein a suture closure is coupled to the branch section, to a distal end of the thrust shaft, the distal end disposed proximal to, but spaced from, a proximal end of the coupling device and flowing flushing fluid through of the thrust shaft lumen and into and through the first lumen. In some embodiments, flushing fluid is provided to the thrust shaft lumen through a flushing port coupled to the branch section, distal to the suture closure. In some embodiments, flushing fluid is provided to the thrust shaft lumen through a flushing port that is part of the suture closure and is disposed at a proximal end of the suture closure. In some embodiments, rinsing the second lumen includes providing rinsing liquid to a first cavity formed between an outer surface of the thrust shaft and an inner surface of a conduit of the branch section, flowing the rinsing liquid from the first cavity. to a second cavity formed between a casing MA / a / 2U21 / Ul 4203 of the thrust shaft and a main tube of the thrust shaft, and flow the flushing fluid from the second cavity to the second lumen. In some embodiments, the method may further include, during deployment and positioning of the covered coupling device, arranging a distal tip of the distal section of the sleeve shaft to extend a distance beyond, in the distal direction, a distal end of the coupling device. In some embodiments, the method may further include deploying a prosthetic heart valve within the central region of the coupling device. In another representative embodiment, a method of providing flushing fluid to a delivery system configured to deliver a coupling device to a native valve of a heart may include: flowing flushing fluid through an internal lumen of the thrust shaft that extends through the interior of a thrust shaft of the delivery system to a distal end of the thrust shaft, wherein the thrust shaft is arranged coaxial with and at least partially within a sleeve shaft of the delivery system, the Sleeve shaft and thrust shaft are disposed within an outer shaft of the delivery system that extends distally from a handle assembly of the delivery system, the sleeve shaft includes a flush through the lumen of the thrust shaft and toward the sleeve shaft lumen and fluid flow through the supply shaft lumen occurs during advancement of a distal end portion of the delivery system, including the coupling device disposed therein, to the native valve and positioning the coupling device, while covered by the sleeve shaft, into the native valve. In some embodiments, the flow of flushing fluid through the push shaft lumen and into the sleeve shaft lumen and the flow of fluid through the supply shaft lumen occurs during preparation of the delivery device for a procedure. implantation, before inserting the delivery device into a patient. In some embodiments, flowing rinse fluid through the supply shaft lumen includes flowing rinse fluid from a first rinse port coupled to a conduit of a hub assembly of the supply system to a first cavity formed between a surface exterior of the thrust shaft and an interior surface of the conduit, flowing flushing fluid from the first cavity to a second cavity disposed between an interior surface of a housing of the thrust shaft and an exterior surface of a main tube of the thrust shaft, and flowing flushing fluid from the second cavity to the supply shaft lumen. In some embodiments, flowing rinse fluid through the supply shaft lumen includes flowing rinse fluid from a first flush port coupled to the conduit and in direct fluid communication with the first cavity, toward the first cavity. In some embodiments, flowing the rinse fluid through the thrust shaft lumen and into the sleeve shaft lumen includes flowing the rinse fluid from a second coupled rinse port to the conduit, near where the first port rinse is coupled to the conduit, and in direct fluid communication with the thrust shaft lumen, in the thrust shaft lumen. In some embodiments, the method may further include maintaining the flow of rinse fluid from the first rinse port to the first cavity separate from the flow of rinse fluid from the second rinse port to the thrust shaft lumen. In some embodiments, a coupling device for coupling a prosthetic valve to a native heart valve includes a coil extending along a central axis, including a front coil, a central region and a stabilization coil, wherein the central region has a plurality of turns having substantially equal inner diameters, the inlet turn extends from one end of the central region and has a diameter greater than the diameter of the central region, and the stabilization turn has a diameter greater than the diameter of the central region and extends from the opposite end of the central region from the main loop. In some embodiments of a docking device, the stabilization loop is designed to create three points of contact in a native anatomy. In some embodiments of a coupling device, the stabilization loop is designed to sit lower in clearance than the central region, thereby elevating the central region. In some embodiments of a coupling device, the stabilization loop has a diameter larger than an opening of a native mitral valve, but smaller enough to rest on the mitral plane. In some embodiments of a coupling device, the stabilization loop is configured to create a ring around a deployed prosthetic valve. In some embodiments of a coupling device, the central region has at least three complete turns. In some embodiments of a coupling device, the stabilization loop has a cover to form a seal against a prosthetic valve. In some embodiments of a coupling device, the cover is and / or comprises a foam. In some embodiments of a coupling device, the cover is and / or comprises a braided structure, such as a nitinol braided structure and / or a covered nitinol braided structure (e.g., covered with cloth, fabric, polymer, foam, etc.). In some embodiments of a coupling device, the shell has pores sized to be atraumatic to native tissues and allow tissue growth into the shell. In some embodiments of a coupling device, the coupling device further includes a soft cover along the entire length of the coil to reduce friction and maintain retention forces for a prosthetic valve. In some embodiments of a coupling device, the soft cover comprises a plurality of ePTFE layers bonded together. In some embodiments of a coupling device, the attachment is intermittent to increase the gumminess of the soft shell. In some embodiments of a coupling device, the shapes of the central region comprise at least three turns, including a proximal turn, a distal turn and at least one intermediate turn, where the proximal turn is the turn closest to the turn of stabilization and the distal turn is the turn closest to the main turn, and where the central region forms a generally hourglass structure, where the distal turn and the proximal turn have a diameter greater than the at least one turn intermediate. In some embodiments of a coupling device, the shapes of the central region comprise at least three turns, including a proximal turn, a distal turn and at least one intermediate turn, where the proximal turn is the turn closest to the turn of stabilization and the distal turn is the turn closest to the main turn, and wherein the central region forms a generally barrel structure, wherein the at least one intermediate turn has a larger diameter than the distal turn and the proximal turn. In some embodiments of a coupling device, the coupling device includes a bead created by joining the stabilization loop to the next adjacent loop in the central region using a fabric. In some embodiments of a coupling device, the coil incorporates a radiopaque marker. In some embodiments of a coupling device, the radiopaque marker is located a quarter turn around the entrance turn. In some embodiments, an implantable prosthetic heart valve includes an annular frame that has an inflow end and an outflow end and that is radially foldable and expandable between a radially collapsed configuration and a radially expanded configuration, the frame defining a axial direction extending from the inlet flow end to the outlet flow end, a leaflet structure positioned within the frame and secured thereto, and a flange attached to the inlet flow end of the annular frame and designed to extend toward outside from it. In some embodiments, an implantable prosthetic heart valve has a flange constructed of and / or comprising a memory material (e.g., a shape memory alloy, a shape memory metal, nitinol, etc.). In one embodiment of an implantable prosthetic heart valve, the flange is made of and / or comprises nitinol. In some embodiments of an implantable prosthetic heart valve, the flange is attached to the annular frame with an intermediate fabric. In some embodiments of an implantable prosthetic heart valve, the implantable prosthetic heart valve further includes a skirt attached to an outer surface of the annular frame. In some embodiments of an implantable prosthetic heart valve, the skirt is constructed and / or comprises at least one of foam and fabric. In some embodiments of an implantable prosthetic heart valve, the foam is selected from at least one of the group consisting of polyurethane and polyurethanepolycarbonate matrix. In some embodiments of an implantable prosthetic heart valve, the skirt is expandable. In some embodiments of an implantable prosthetic heart valve, the skirt comprises both fabric and foam. In some embodiments of an implantable prosthetic heart valve, the annular frame includes a memory material embedded in or located under the skirt to aid expansion of the skirt and is manufactured using fabric and foam. In some embodiments of an implantable prosthetic heart valve, the skirt has a larger diameter near the inflow end of the prosthetic valve than near the outflow end of the prosthetic valve. In some embodiments of an implantable prosthetic heart valve, the skirt has a pocket for placement of an embolic material. In some embodiments of an implanted prosthetic heart valve, the pocket has a pore to allow insertion of embolic material. In some embodiments of an implanted prosthetic heart valve, the wrist has a permeable or semipermeable shell to allow fluid exchange between the emdolic material and the native blood. In some embodiments of an implanted prosthetic heart valve, the emdolic material is selected from a hydrogel, an ethylene vinyl alcohol dissolved in dimethyl sulfoxide, and an n-butyl cyanoacrylate. In some embodiments, a system for implanting a coupling device into a native valve includes a delivery catheter, an elongated coil coupling device having an end portion, a thrust shaft disposed on the delivery catheter and coupled to the portion. end of the coupling device, and a sleeve shaft located coaxially with the push shaft and disposed between the delivery catheter and the push shaft, wherein the system is configured so that the push shaft and the sleeve shaft operate in parallel. In some embodiments of a system for implanting a coupling device in a native valve, the sleeve shaft comprises a distal section, a middle section and a proximal section, wherein the distal section forms a WUUa / 2U21 / Ul 4200 lubricating sleeve covering the coupling device, and the proximal section is used to activate the position of the lubricating sleeve. In some embodiments of a system for implanting a coupling device in a native valve, the lubricating sleeve is and / or comprises a low friction material. In some embodiments of a system for implanting a coupling device in a native valve, the lubricating sleeve has a hydrophilic coating. In some embodiments of a system for implanting a coupling device in a native valve, the lubricating sleeve has a hydrogel coating. In some embodiments of a system for implanting a coupling device in a native valve, the proximal section is rigid and has a cut portion to allow access to the thrust shaft. In some embodiments of a system for implanting a docking device into a native valve, the distal section and the midsection are flexible and each is constructed of a polymer and a braided structure. In some embodiments of a system for implanting a coupling device in a native valve, the polymer is and / or comprises a polyetheramide block copolymer or a mixture of two or more polyether-amide block copolymers. In some embodiments of a system for implanting a coupling device in a native valve, the braid is and / or comprises stainless steel. In some embodiments of a system for implanting a coupling device in a native valve, the distal section has a high density braid. In some embodiments of a system for implanting a coupling device in a native valve, the middle section has a braid of lower density than the distal section. In some embodiments of a system for implanting a coupling device in a native valve, the push shaft includes a hypo main tube having a distal end attached to the coupling device and a proximal end opposite the distal end, a housing, a plug , and a proximal extension, where the housing runs coaxially to the main hypo tube and the cuff shaft, is welded to the proximal end of the main hypo tube using the plug, and is disposed between the catheter and the cuff shaft, and wherein The proximal extension extends from the proximal end of the hypo main tube. In some embodiments of a system for implanting a coupling device into a native valve, the proximal extension is constructed of a flexible material. In some embodiments of a system for implanting a coupling device in a native valve, the housing and plug are welded to the main hypotube to allow the cut portion of the sleeve shaft to slide between the main hypotube and the housing. In some embodiments of a system for implanting a coupling device into a native valve, the system for implanting a coupling device into a native valve further includes a handle assembly. In some embodiments of a system for implanting a coupling device into a native valve, the handle assembly includes a general Y-shaped connector. In some embodiments of a system for implanting a coupling device in a native valve, the Y-shaped connector has a straight section and a branch, where the sleeve axis extends to the end of the straight section and the proximal extension. extends to the end of the branch. In some embodiments of a system for implanting a docking device into a native valve, the handle assembly further includes a flush port. In some embodiments of a system for implanting a coupling device in a native valve, the flush port is configured such that a plurality of lumens formed between the catheter, the cuff shaft and the MA / a / 2U21 / Ul 4203 thrust shaft can be discharged simultaneously from a single port. In some embodiments of a system for implanting a coupling device into a native valve, the handle assembly includes a hemostatic seal located in the formed straight section and having a first end located proximal to an opening in the shape of the sleeve shaft. In some embodiments of a system for implanting a coupling device in a native valve, the sleeve shaft has a laser cut portion that forms an overall U-shaped structure, and the opening has a U shape. In some embodiments of a system for implanting a coupling device into a native valve, the handle assembly further includes a first rigid washer located at one end of the hemostatic seal and a second rigid washer at the second end of the hemostatic seal. In some embodiments of a system for implanting a coupling device in a native valve, the first and second rigid washers exert inward pressure on the hemostatic seal to form a seal between the hemostatic seal and the sleeve shaft. In some embodiments of a system for implanting a coupling device in a native valve, the handle assembly further includes a closure cap assembly. In some embodiments of a system for implanting a coupling device in a native valve, the closure cap assembly allows adjustment of inward pressure between the first and second rigid washers and the hemostatic seal to immobilize the sleeve shaft. The present invention provides methods for delivering implants into the native valves of a heart. The methods can be used to deliver any of the implants described herein, including the docking devices described herein. In some embodiments, the methods may comprise placing the selected coupling device on the native valve of the heart, such that at least a portion of the main turn of the coupling device is placed in a ventricle of the heart and around one or more leaflets. native valve valve. In certain embodiments, implantation of the coupling device may act to remodel one or more tissues in the heart to repair native valve function. In some embodiments, the methods may comprise delivering the coupling device to a native mitral valve to repair the left ventricle and associated cardiac function. In some embodiments, the methods can reduce the diameter of the ring and put tension on the cords. In some embodiments, the methods may further include performing an edge-to-edge repair on the native mitral valve leaflets, such as, for example, placing a clip to secure a free edge of the anterior mitral valve leaflet to a free edge of the posterior mitral valve leaflet. In some embodiments, the methods may comprise placing an implantable prosthetic heart valve within the coupling device after the coupling device is placed on the native heart valve in the desired position. The methods can be used to deliver any of the implantable cardiac valve prostheses described herein. In some embodiments, suitable implantable prosthetic heart valves that can be used in the methods may have 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, the frame defining an axial direction extending from the inlet flow end to the outlet flow end; a shell structure placed within the frame and secured thereto; and a flange attached to the inlet flow end of the annular frame and designed to extend outwardly therefrom. In certain embodiments, the methods may further comprise placing the implantable prosthetic heart valve in a radially collapsed configuration within the coupling device and expanding the implantable prosthetic heart valve from the radially collapsed configuration to a radially expanded configuration, such that a pressure is applied. radially outwardly by the frame of the implanted prosthetic heart valve in at least a portion of a central region of the coupling device. In some aspects, the present invention further provides methods for delivering implants using delivery systems described elsewhere herein. In certain embodiments, delivery systems suitable for use in the methods may include a delivery catheter, the coupling device with an end portion at the end of the staging loop located opposite the central region, a thrust shaft arranged in the delivery catheter and coupled to the end portion of the coupling device and a sleeve shaft located coaxially with the thrust shaft and disposed between the delivery catheter and the thrust shaft. In some embodiments, the delivery system can be configured so that the thrust shaft and the sleeve shaft operate in parallel. In certain embodiments, the positioning step of the methods may comprise pushing the coupling device away from the catheter with the pushing shaft. In various embodiments, the methods may be carried out on a living animal or non-living cadaver, cadaver heart, simulator (e.g., simulating body parts, tissue, etc.), anthropomorphic ghost, etc. The above and other objects, features and advantages of the described technology will become more apparent from the following detailed description, which proceeds with reference to the accompanying figures. Brief Description of the Figures Figure 1 shows a schematic cross-sectional view of a human heart according to various embodiments. Figure 2 shows a schematic top view of a mitral valve annulus of a heart according to various embodiments. Figure 3A illustrates a perspective view of one embodiment of a prosthetic heart valve having a flange according to various embodiments. Figure 3B illustrates a side view of one embodiment of a prosthetic heart valve having a flange according to various embodiments. Figure 3C illustrates a perspective view of an exemplary embodiment of a prosthetic heart valve having commissure flanges according to various embodiments. Figures 4A-4C illustrate views of exemplary embodiments of a prosthetic heart valve having a cover according to various embodiments. Figures 5A-5F illustrate views of example embodiments having sculpted liners according to various embodiments. Figure 6A illustrates a side view of one embodiment of a prosthetic heart valve having a woven fabric cover according to various embodiments. Figure 6B illustrates a side view of one embodiment of a prosthetic heart valve having a hybrid cover according to various embodiments. Figures 6C-6E illustrate views of one embodiment of a prosthetic heart valve having an edge cover according to various embodiments. Figures 7A-7C illustrate views of a prosthetic heart valve having a flexible flange support according to various embodiments. Figure 8 illustrates a prosthetic heart valve having outward struts according to various embodiments. Figure 9A illustrates a top view of an exemplary embodiment of a coupling device or a core of a coupling device with three contact points in the left atrium according to various embodiments. Figures 9B and 9C illustrate side views of an exemplary embodiment of a coupling device or a core of a coupling device with three contact points in the left atrium according to various embodiments. Figures 10A and 10B illustrate top views of exemplary embodiments of coupling devices with a planar stabilization or atrial twist according to various embodiments. Figures 10C and 10D illustrate side views of an exemplary embodiment of a coupling device or a core of a coupling device with a planar stabilization or atrial twist according to various embodiments. Figure 11A illustrates a top view of an exemplary embodiment of a hybrid coupling device or a core of a hybrid coupling device according to various embodiments. Figures 11B and 11C illustrate side views of an exemplary embodiment of a hybrid coupling device or a core of a hybrid coupling device according to various embodiments. Figures 12A-12D illustrate top views of exemplary embodiments of a coupling device having a cover on the atrial stabilization or rotation according to various embodiments. Figure 12E illustrates a perspective view of an exemplary embodiment of a coupling device having a cover in a functional rotation according to various embodiments. Figure 12F illustrates a cross-sectional view of a first part of the cover of the coupling device of Figure 12E according to various embodiments. Figure 12G illustrates a cross-sectional view of a second portion of the cover of the coupling device of Figure 12E according to various embodiments. Figure 12H illustrates a top or plan view of a mitral valve, with the leaflets closed and coapulated and indicating primary anatomical landmarks, as well as diagram lines indicating features of the coupling device of Figure 12E according to various embodiments. . Figure 13A illustrates a schematic view of example embodiments of a coupling device having a cover according to various embodiments. Figures 13B-13C illustrate cross-sectional views of example embodiments of a coupling device having a cover according to various embodiments. Figures 14A and 14B illustrate cross-sectional views of example embodiments of a coupling device having soft covers according to various embodiments. Figure 14C illustrates an elongated linear view of a soft cover attachment scheme according to various embodiments. Figures 15A and 15B illustrate side views of exemplary embodiments of coupling devices having an hourglass shape in the central region according to various embodiments. Figures 15C and 15D illustrate side views of exemplary embodiments of coupling devices having a barrel shape in the central region according to various embodiments. Figure 16 illustrates a perspective view of an exemplary embodiment of a coupling device having a tab on the stabilization or earpiece swivel in accordance with various embodiments. Figure 17A illustrates an example embodiment of a sleeve shaft according to various embodiments. Figure 17B illustrates a cross-sectional side view of the sleeve shaft of Figure 17A. Figure 17C illustrates a detailed view of a portion of the sleeve shaft of Figure 17B, showing an interface between different materials of the sleeve shaft. Figure 17D illustrates a side view of an exemplary embodiment of a flexible polymer sleeve of the sleeve shaft of Figure 17B. Figure 17E illustrates a side view of an exemplary embodiment of a more rigid tube portion of the sleeve shaft of Figure 17B. Figure 18 illustrates an exemplary embodiment of a layered construction of a lubricating sleeve according to various embodiments. Figure 19 illustrates a cross-sectional side view of an exemplary embodiment of a flexible tip for the sleeve shaft of Figure 17B. Figure 20A illustrates a side view of an example embodiment of a proximal section of a sleeve shaft according to various embodiments. Figure 20B illustrates a perspective view of an example embodiment of a more rigid tube portion of a proximal section of a sleeve shaft according to various embodiments. Figure 20C illustrates a perspective view of an exemplary embodiment of an interface between the tube portion of Figure 20B and an inner liner in the proximal section of the sleeve shaft according to various embodiments. Figure 20D illustrates a perspective view of an exemplary embodiment of an outer flexible polymer layer disposed on the tube portion and the inner liner of Figure 20C in the proximal section of the sleeve shaft in accordance with various embodiments. Figure 21A illustrates a first cross-sectional side view of an exemplary embodiment of a thrust shaft according to various embodiments. Figure 21B illustrates a second cross-sectional side view of an exemplary embodiment of a thrust shaft according to various embodiments. Figure 21C illustrates a detailed view of a distal end of the thrust shaft of Figure 21B. Figure 21D illustrates a view of the proximal end of the thrust shaft of Figure 21B. Figure 21E illustrates a side view of a tube portion of the thrust shaft of Figure 21B. Figure 21F illustrates a side view of a housing of the thrust shaft of Figure 21B. Figure 21G illustrates an end view of a thrust shaft plug of Figure 21B. Figures 22A-22C illustrate an example embodiment of a sleeve shaft and a thrust shaft interacting according to various embodiments. Figure 23A illustrates a side view of an example embodiment of a proximal extension of a thrust shaft according to various embodiments. Figure 23B illustrates a perspective view of the thrust shaft that includes the proximal extension of Figure 23A. Figure 24A illustrates an example embodiment of a portion of a handle assembly for a delivery system for a coupling device according to various embodiments. Figure 24B illustrates an example embodiment of a delivery system for a coupling device. Figure 25 illustrates an example embodiment of a rinse plate according to various embodiments. Figures 26A and 26B illustrate example embodiments of a hemostatic seal according to various embodiments. Figure 27A illustrates an example embodiment of a portion of a handle assembly for a delivery system that includes a suture closure and a sleeve handle according to various embodiments. Figure 27B illustrates a perspective view of the suture closure of Figure 27A, disconnected from a branch of the handle assembly. Figure 27C illustrates an exploded view of the suture closure of Figure 27A. Figure 28A illustrates a side view of an embodiment of the suture closure of Figures 27A-27C that includes a flush port at a proximal end of the closure WUUa / 2U21 / Ul 4200 suture. Figure 28B illustrates a perspective view of a detailed portion of the suture closure of Figures 27A27C, showing a release knob and an internal release bar. Figure 28C illustrates a cross-sectional side view of the suture closure release bar of Figure 28B. Figure 28D illustrates a perspective view of the release bar of Figures 28B and 28C. Figure 28E illustrates a detailed cross-sectional view of a suture cut portion of the release bar of Figures 28B-28D. Figures 29A-29E illustrate example embodiments of directional mechanisms for a suture closure according to various embodiments. Figures 30A-30C illustrate an exemplary embodiment of a suture cutting and removal mechanism according to various embodiments. Figures 31A and 31B illustrate example embodiments of a coil holder according to various embodiments. Figures 32A-32C illustrate a method of expanding a cover over a coupling device according to various embodiments. Figure 33 illustrates a perspective view of an exemplary embodiment of a sleeve shaft covering a coupling device and extending out of a delivery catheter of a delivery system. Figure 34 illustrates the sleeve shaft surrounding a thrust shaft after deploying the coupling device of the delivery system of Figure 33 and removing the sleeve shaft from the coupling device. Figure 35 illustrates a cross-sectional side view of a portion of a handle assembly and fluid flow through the lumens of the handle assembly. Figure 36 illustrates a cross-sectional perspective view of a more detailed portion of the handle assembly of Figure 35 and fluid flows through the lumens of the handle assembly. Figure 37 illustrates a perspective cross-sectional view of a portion of a delivery system, including a thrust shaft and a sleeve shaft, arranged coaxially with each other, and fluid flow through lumens disposed between the components. coaxial. Figure 38 illustrates a schematic of fluid flow through the lumens of a distal end portion of a delivery system, the delivery system including a thrust shaft, sleeve shaft and coupling device disposed on an outer shaft of the system of supply. Figure 39 is a flow chart of a method for delivering a coupling device to a native valve of a heart and implanting the coupling device and an associated prosthetic heart valve into the native valve. Detailed description of the invention Disclosed herein are various systems, apparatus, methods, etc., including anchoring or docking devices, that may be used in conjunction with expandable prosthetic valves (e.g., transcatheter heart valves (THVs)) in a native valve annulus. (e.g. mitral or tricuspid valve ring), in order to more securely implant and hold the prosthetic valve at the implant site. Anchoring / coupling devices according to embodiments of the invention provide or form a more circular and / or stable anchoring site, support zone or implantation zone at the implant site, where the prosthetic valves can be expanded or implanted in different ways. another way. Many of these coupling devices and prosthetic valves have circular or cylindrical valve structures or stents that can be expanded or otherwise implanted in locations with naturally circular cross sections. However, additional modalities of coupling devices and prosthetic valves have other geometries (e.g., oblong, ovular, longitudinally curved, etc.) that are more appropriate for non-circular and / or non-cylindrical anatomies. In addition to providing an anchorage site for the prosthetic valve, anchoring / docking devices can be sized and shaped to fit or pull the native valve anatomy (e.g., mitral, tricuspid, etc.) radially inward. Thus, one of the main causes of valvular regurgitation (e.g., functional mitral regurgitation), specifically enlargement of the heart (e.g., left ventricular enlargement, etc.) and / or valve annulus, and subsequent stretching outside the annulus of the native valve (e.g. mitral, etc.), can be at least partially compensated or counteracted. Some embodiments of the anchoring or coupling devices further include features that, for example, are shaped and / or modified to better maintain a position or shape of the coupling device during and / or after expansion of a prosthetic valve therein. By providing such anchoring or coupling devices, replacement valves can be more securely implanted and secured in various valve annuli, including in the mitral annulus which does not have a naturally circular cross section. Referring first to Figures 1 and 2, the mitral valve 10 controls the flow of blood between the left atrium 12 and the left ventricle 14 of the human heart. After the left atrium 12 receives oxygenated blood from the lungs through the pulmonary veins, the mitral valve 10 allows the flow of oxygenated blood from the left atrium 12 into the left ventricle 14. When the left ventricle 14 contracts, the Oxygenated blood that was retained in the left ventricle 14 is supplied through the aortic valve 16 and aorta 18 to the rest of the body. Meanwhile, the mitral valve must close during ventricular contraction to prevent blood from flowing back into the left atrium. When the left ventricle contracts, the blood pressure in the left ventricle increases substantially, which serves to force the mitral valve to close. Due to the large pressure difference between the left ventricle and the left atrium during this time, a large amount of pressure is placed on the mitral valve, leading to the possibility of prolapse or eversion of the mitral valve leaflets into the mitral valve. atrium. Therefore, a series of chordae tendineae 22 connect the leaflets of the mitral valve to the papillary muscles located in the walls of the left ventricle, where both the chordae tendineae and the papillary muscles tighten during ventricular contraction to keep the leaflets in place. the closed position and to prevent them from spreading towards the left atrium. This helps prevent reflux of oxygenated blood into the left atrium. The chordae tendineae 22 are illustrated schematically in both the cross section of the heart of Figure 1 and the top view of the mitral valve of Figure 2. Figure 2 shows a general shape of the mitral valve and its leaflets as seen from the left atrium. The commissures 24 are located at the ends of the mitral valve 10 where the anterior leaflet 26 and the posterior leaflet 28 meet. Various mitral valve complications can cause fatal heart failure. One form of valvular heart disease is mitral valve leak or mitral regurgitation, characterized by abnormal leakage of blood from the left ventricle through the mitral valve into the left atrium. This may be caused, for example, by dilation of the left ventricle causing the native mitral leaflets to not fully accommodate, resulting in leakage, by damage to the native leaflets or weakening of (or damage to) the chordae tendineae. and / or papillary muscles. In these circumstances, it may be desirable to repair the mitral valve or replace the functionality of the mitral valve with that of a prosthetic heart valve. The field of transcatheter aortic valve replacement has become much more developed and has seen widespread success than transcatheter mitral valve replacement. This discrepancy is due, in part, to the fact that mitral valve replacement is more difficult than aortic valve replacement in many ways, such as, for example, due to the non-circular physical structure of the mitral valve, its anatomy. subannular and more difficult access to the valve. Additionally, the mitral valve often lacks calcification, which limits the ability of prosthetic valves to anchor within the mitral valve. One of the most important obstacles to mitral valve replacement is effective anchoring or retention of the valve in the mitral position, because the valve is subject to high cyclic loading. As noted above, another problem with mitral valve replacement is the size and shape of the native mitral annulus, as can be seen in Figure 2. Aortic valves are more circular or cylindrical in shape than mitral valves. Additionally, the mitral and tricuspid valves are larger than the aortic valve and have a more elongated shape, making them more difficult and unconventional to implant a replacement valve with a generally circular or cylindrical valve frame. A circular prosthetic valve that is too small can cause a leak around the implant (i.e., paravalvular leak) if a good seal is not established around the valve, while a circular prosthetic valve that is too large can stretch and damage the valves. narrower parts of the native mitral annulus. Additionally, in many cases, the need for aortic valve replacement arises due to, for example, aortic valve stenosis, where the aortic valve narrows due to calcification or other hardening of the native leaflets. Therefore, the aortic annulus generally forms a more compact, rigid, and stable anchoring site for a prosthetic valve than the mitral annulus, which is both larger than the aortic annulus and noncircular. Cases of mitral valve regurgitation are unlikely to provide such a good anchorage site. Additionally, the presence of the chordae tendineae and other anatomy in the mitral position can form obstructions that make it much more difficult to properly anchor a device in the mitral position. Other obstacles to effective mitral valve replacement may arise from the large cyclic loads on the mitral valve and the need to establish sufficiently strong and stable anchorage and retention. Additionally, even a slight change in the alignment of the valve can cause blood flow through the valve or other parts of the heart to be obstructed or negatively affected. Modalities of a prosthetic valve Valve prostheses according to exemplary embodiments are shown in Figures 3A to 6B. Although specific examples of prosthetic heart valves are discussed herein, the general structure, method of manufacture, and methods of use of various prosthetic valves, which may be adapted for use with the anchorage / coupling devices of this document, are describe in at least US Patent No. 10,195,025 entitled Prosthetic Heart Valve; US Patent Pub. No. US 2018 / 0206982 titled Covered Prosthetic Heart Valve and US Patent Application 16 / 252,890 titled Covered Prosthetic Heart Valve, the disclosure of each of which is incorporated herein by reference in its entirety. Figures 3A and 3B illustrate an example of prosthetic valve 30 with a flange 32 attached to the earpiece (inflow end) 34 of the prosthetic valve 30 and extending radially outward by 360° in accordance with various embodiments. In many of these embodiments, flange 32 is designed to rest in a plane of the native valve, such as in a plane of the native mitral valve, tricuspid valve, etc. Flange 32 of some embodiments is designed to stimulate flow through the prosthetic valve 30 to prevent and / or reduce paravalvular leak. Figure 3C illustrates a prosthetic valve 30 that includes flanges 32 and 32' that are designed to cover only the mitral commissures instead of the entire mitral plane. Tabs 32 and 32' that only cover the commissures could beneficially reduce the folded or compressed size of the valve for a narrower 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 of an elastic material that can be compacted into a catheter for placement. In certain embodiments, flange 32 (or flanges 32 and 32') is made of and / or comprises a memory material that can be compressed or manipulated and returns to a specific shape once a force is removed. An example of a memory material is nitinol (or NiTi), but other shape memory alloys or shape memory metals can be used. The memory material may be formed into a fabric or frame that is compressible and returns to its formed shape (e.g., a tab) once released from a catheter. In some embodiments, the flange 32 is attached to the frame of the prosthetic valve through a fabric intermediate 36. Turning to Figures 4A and 4B, exemplary embodiments of prosthetic valves 40 are illustrated comprising a cover 42, such as a skirt, on the outer surface of the prosthetic valve 40. In covered embodiments, the cover can be designed and / or configured to prevent paravalvular leaks between the prosthetic valve 40 and the native valve, to protect the native anatomy, to promote tissue growth and / or be designed / configured for others MA / a / 2U21 / Ul 4203 purposes. Due to the overall D shape of the mitral valve (see Figure 2) and the relatively large annulus compared to the aortic valve, the cover 42 acts as a seal around the prosthetic valve 40 (for example, when the valve has a smaller size than that of the aortic annulus) and allows for smooth coaptation of the native leaflets against the prosthetic valve 40. In various embodiments, the cover 42 is composed of a material that can be crimped for transcatheter placement of the prosthetic valve and is expanded it to prevent paravalvular leaks around the prosthetic valve. Examples of possible materials include foam, cloth, fabric, one or more polymers, and / or an encapsulated material, such as an encapsulated hydrogel. In certain embodiments, the cover is joined by loop seams 63, as illustrated in Figure 4A, while additional embodiments will use an edge cover strip 65 with radial horizontal seams, as illustrated in Figure 4B. Edge cover strip 65 of many embodiments is constructed of any suitable material that is biocompatible and atraumatic to the native tissue, including ePTFE, bovine pericardium, porcine pericardium, equine pericardium, woven PTFE, woven PTFE, braided PTFE, polyurethane, ePTFE electrospun, dipped thermopyastics, sprayed thermoplastics, other organic fabrics, other non-organic fabrics and combinations thereof. Turning to Figure 40, the coating solutions (e.g., on cloth, fabric, etc.) of some embodiments will form a pocket 46, such as a cup or bag shape, to allow the insertion, injection or encapsulation of a embolic material after valve placement and allow free exchange of fluid with native blood. Certain embodiments that include a pocket include one or more pores 44 in a shell layer to allow an outer layer to inflate during systole. In some embodiments, an encapsulated material can provide an attractive expansion mechanism. Certain modalities are inflated by receiving blood from the atrial side of the prosthetic valve. In additional embodiments, a pore 44 or port allows insertion of the embolic material with limited exposure to native blood, while additional embodiments encapsulate the embolic material completely or almost completely. In some encapsulated embodiments, the skirt may have a permeable or semipermeable cover to allow fluid exchange between the encapsulated material and the blood. In some embodiments, the embolic material is injected through a catheter or syringe. Other modalities expand the pocket using monofilament deformation and / or buckling. An example of monofilament warping is discussed in more detail in this paper with reference to Figure 8. In various embodiments, the embolic material will be a hydrogel. Some hydrogels expand at body temperature; Therefore, selecting a hydrogel expanded at body temperature allows a patient's natural heat to provide expansion of the hydrogel around a prosthetic valve to prevent paravalvular leaks. Other modalities will have a hydrogel that expands by absorbing a fluid, for example, blood. In such embodiments, the hydrogel can be inserted into the skirt prior to valve deployment, and the presence of blood after deployment will allow the hydrogel to expand. Additional embodiments will use a precipitation composition, such as ethylene vinyl alcohol (EVOH) dissolved in dimethyl sulfoxide (DMSO). Certain EVOH-DMSO compositions are known in the art, including formulations of ONYX® LIQUID EMBOLIC SYSTEM™ (Micro Therapeutics, Inc., Irvine, California, USA) ONYX® 18 (6% EVOH), ONYX® 34 (8% EVOH), ONYX® HD-500 (20% EVOH) or mixtures thereof. In such embodiments, the EVOH-DMSO composition will be inserted into the skirt after or during valve deployment. The DMSO in these compositions will be carried away by the blood, leaving the EVOH behind, thus forming an embolic to prevent paravalvular leak. In certain embodiments, the embolic material may be an n-butyl cyanoacrylate. Some suitable embolic materials may be liquid 2-alkyl cyanoacrylate monomers that, in contact with ionic media (e.g., water, blood), form flexible polymers that can form adhesive bonds to soft tissues. These isolated liquid monomers are nonviscous, radiolucent, and can polymerize rapidly. In certain embodiments, the embolic material may be a multicomponent formulation that includes the cyanoacrylate and a radiopaque material, etiodinated oil, or both. In some embodiments, additional components can prolong the polymerization time, opacify the liquid agent and allow 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). In additional embodiments, the embolic material may include one or more radiopaque materials that provide visualization under fluoroscopy. In certain embodiments, the radiopaque materials may comprise one or more salts, compounds or nanoparticles containing iodine, barium, tantalum, bismuth or gold. In some embodiments, the radiopaque material may be a tantalum powder. Embodiments incorporating foam solutions provide a cover that attaches to the outside of the valve frame to provide a substantial paravalvular leak solution, while maintaining a low crimp profile that allows the device to be administered via a catheter. In certain embodiments, one or more foam materials may be used to achieve a low device profile while crimped, and provide expansion in the mitral position and a soft, smooth surface to interact with the native mitral valve. Possible foam materials include polyethylene terephthalate, polyurethane, and polyurethane-polycarbonate matrix for long-term implantation. Foam may be advantageous over a fabric cover, because foam can typically be compressed to a smaller crimp profile, and the amount of swelling in the mitral valve is substantially more effective in reducing the amount of paravalvular leak based on volume. increased foam. Additionally, the foam can be extremely compliant and atraumatic to coaptation of the mitral anatomy. Other advantages of foam include tissue growth and echogenicity. The advantages of tissue ingrowth arise because foam is typically more porous than other materials, and porosity may allow for better or enhanced tissue growth. Improved echogenicity is advantageous because it allows a user, such as a physician, cardiologist, surgeon or other medical professional, to see the placement of the prosthetic valve based on where the foam has expanded. A prosthetic valve cover can be WUUa / 2U21 / Ul 4200 further alter to allow alterations to the inlet and outlet portions of a prosthetic valve (for example, the shapes do not always have to be perfectly cylindrical, as shown previously), as seen in the figures 5A-5F. In these figures, the frame 50 has a cover 52 that is machined, heat molded or otherwise manufactured in a shape to allow a larger outside diameter at the inlet flow portion 54. Various embodiments will have certain shapes, as shown. illustrated in Figures 5A-5F. Some embodiments will have a generally conical shape, as illustrated in Figure 5A, having a larger outer diameter at the inlet flow portion 54 that gradually tapers to a smaller outer diameter at the outlet flow portion 56. Another set of embodiments will have a curved and tapering cover 52, such as in Figure 5B, where the cover 52 is wider near the inlet flow portion 54 and has a generally curved taper towards the outlet flow portion 56. . Additional embodiments will generally have hourglass shapes, such as those illustrated in Figures 5C to 5E. As illustrated in Figure 5C, some embodiments will have larger outer diameters in the inflow portion 54 and in the outflow portion 56, while having a narrower outer diameter in the middle portion 58 of the prosthetic valve. fifty. Another form of covers 52 used in some embodiments is illustrated in Figure 5D, where the cover 52 retracts slightly from the inlet flow portion 54 of the prosthetic valve 50 and has a larger outer diameter toward the inlet flow portion. entry 54; In addition, the cover 52 has a larger outer diameter at the outlet flow portion 56 and has a smaller outer diameter at a position 58 proximal to the outlet flow portion 56. Figure 5E illustrates embodiments in which the cover 52 has a constriction 53 designed to prevent compression of the foam from influencing the volume and / or shape of a first portion 57. Because the constriction 53 is designed to prevent compression of the first portion 57, the constriction 53 It can be located in any position along the body to achieve this goal. For example, the constriction 53 may be proximal to the inlet portion (as illustrated), or may be located proximal to the outlet flow portion 56 or midway between the outlet flow portions 56 and inlet 54. In many of these embodiments, constriction 53 is a machined slot. In many embodiments with constrictions 53, the overall shape of the cover 52 is cylindrical (for example, similar to Figure 4A), while many embodiments will add contours or other shapes to the cover 52. For example, the first portion 57 has a gradual increase in thickness from the inlet flow portion 54, and the second portion 59 has a generally curved cone toward the outlet flow portion 56, as illustrated in Figure 5E. Turning to Figure 5F, other embodiments of the prosthetic valve 50 will have a cover 52 with a general mushroom shape, wherein the cover 52 has a first portion 57 with a curved increase in thickness from the inlet flow portion 54 towards a position 58. The cover 52 will also have a second portion 59 extending towards the outflow portion 56 from position 58, which has a generally cylindrical shape. It should be noted that although some of the embodiments illustrated in Figures 5A to 5F are illustrated with loop seams and other embodiments are illustrated with an edge stripe and radial horizontal seams, these illustrations are not intended to limit the type of seam in any specific embodiment. , and many embodiments will have loop seams or an edge strip independent of the shape of the cover 52 on the prosthetic valve 50. Turning to Figure 6A, numerous embodiments of a valve cover 60 have a cover made of a woven fabric or fabric having a plurality of floating yarn sections 61 (e.g., protruding or swollen sections). Details of exemplary covered valves with a plurality of floating thread sections 61 are described in more detail in pre-grant US Patent Publications Nos. US2019 / 0374337 Al, US2019 / 0192296 Al and US2019 / 0046314 Al , the contents of which are incorporated herein in their entirety for all purposes. In certain embodiments, the floating sections are separated by one or more horizontal bands 63. In many embodiments, the horizontal bands 63 are constructed using a gauze fabric, which improves the strength of the woven structure. In some embodiments of woven fabric, the vertical fibers (e.g., running along the longitudinal axis of the valve 60) comprise a yarn or other fiber that has a high level of expansion, such as a textured weft yarn, while that the horizontal fibers (e.g., running circumferentially around valve 60) in a voile fabric comprise a low expansion yarn or fiber. The floating yarn sections 61 can be thermoset to a desired size and texture, for example, to make them softer and more textured. Texturing can be achieved by causing the constituent fibers of the strands / yarns used in section 61 to be twisted, heat set and unwound so that the fibers retain their twisted and deformed shape and create a voluminous fabric. In some embodiments, the floating yarn section 61 may be formed from textured PET yarns without any weave structure. In certain embodiments, the covered valve cover 60 may be heat-shrinkable to achieve a stretchability between 80-160%. In a variety of embodiments, a woven fabric resembles a raw fabric when assembled and under tension (for example, when stretched longitudinally in a compressed valve 60 prior to delivery of a valve 60). When a valve 60 is deployed and expanded, the tension in the floats 61 relaxes allowing expansion of the floats 61. In many embodiments, the number and sizes of the floats 61 are optimized to provide a level of expansion to prevent paravalvular leaks. through the mitral plane (e.g., to have a higher level of expansion thickness) and / or a lower crimp profile (e.g., for valve delivery), as described in more detail in the publications In addition, the bands 63 can be optimized to allow attachment of the cover to the valve based on the size or the specific position of the struts or other structural elements of the valve. In some embodiments, a valve cover 60 (e.g., as shown in Figure 6B) has a hybrid cover 62, which may comprise a plurality of different types of covers working together. In the example shown in Figure 6B, a first portion 64 of the hybrid cover 62 near the inlet portion 66 of the valve 60 comprises foam or other expandable material, while a second portion 68 of the hybrid cover 62 near the outlet portion 69 of valve 60 comprises woven fabric or fabric, which may have one or more expandable portions 61. Additionally, in Figure 6B, the foam or other expandable material has a larger expanded profile at the inlet portion to increase the ability to form a seal and prevent paravalvular leaks around the mitral plane. Due to the compressibility of the foam / expandable material along with the low profile capability of the woven fabric, this hybrid foam and fabric skirt beneficially achieves a low profile when the valve is crimped. The expanded valve expands radially outward at the inflow end to allow a good paravalvular seal. Furthermore, Figure 6B illustrates a variation of the edge cover 65. In particular, the edge cover 65 in many embodiments will have a series of openings 67 positioned in the edge cover 65 (Figures 6C-6E). In certain embodiments, the openings are created by die cutting, laser cutting, punching or any other method of creating an opening in the material of the edge cover 65. Turning to Figures 6C and 6D, perspective views of the portion are illustrated. inflow portion 66 (Figure 6C) and outflow portion 69 (Figure 6D). As seen in these figures, the edge cover 65 will have openings 67 at both ends of a prosthetic valve of many embodiments. Furthermore, Figure 6E illustrates a perspective view from the inside of the outflow portion 69, illustrating the edge cover 65 with a series of openings 67. As illustrated in Figure 6E, the frame 63 of a valve Prosthetics of many modalities have angled struts, which allow compressibility around a catheter or other delivery device. The openings 67 are cut so that they align between the apices in the frame 63. By placing the openings between the apices, the edge cover 65 does not bulge, thus minimizing the outside diameter of a crimped valve, when the prosthetic valves In certain embodiments, a catheter or other delivery device is crimped around. The various embodiments illustrated in Figures 3A-6E are described as foam and / or woven fabric, additional embodiments are constructed with materials capable of providing the same effect, including woven PET, knitted PET, braided PET, woven PTFE, PTFE knitted, braided PTFE, ePTFE membrane, electrospun ePTFE, thermoplastic membrane, dipped thermoplastic, sprayed thermoplastic, foam and combinations thereof. In some embodiments, prosthetic valves with covers will use a material that is placed underneath and / or incorporated with the cover that can be compressed or manipulated and returns to a specific shape once a force is removed. Figures 7A and 7B illustrate a flange support structure 71 for allowing a cover to expand to its full position. Specifically, Figures 7A and 7B illustrate a flange support structure 71 secured to a frame 63 of many embodiments. In various embodiments, the flange support structure 71 is secured near the inlet portion 72 and in a central position 73 of the frame 63. In some embodiments, fastening is achieved by sewing, welding or any other suitable method to ensure a flange support structure 71 to frame 63. In a series of embodiments, the flange support structure 71 has a series of windows 75, which allow the flange support structure 71 to bulge radially outward from the frame 63 and Allow the cover to fully expand into position. Figure 7C illustrates one embodiment of a prosthetic valve with a flange support structure 71 crimped over a delivery device, such as a catheter. In Figure 7C, the compressed frame 63 and the flange support structure 71 do not dramatically increase the outer diameter (double arrow) of the folded frame 63. The flange support structure 71 can be constructed of any general V outward material from frame 63, while other embodiments will have a single outer strut 77 at a specific location that will expand outward from frame 63. Although Figure 8 is illustrated for expansion at or near the auricular or inlet side of frame 63, A similar mechanism is used to expand bag covers (e.g., Figure 4C) on the ventricular or outflow side of frame 63 to assist in the expansion of a bag to encapsulate blood or embolic material. It should be noted that the embodiments illustrated in Figures 3A to 8 are illustrative and are not intended to be exclusive or limiting of any other embodiment, unless the illustrated features are not combinable. For example, various embodiments will combine flange support structures, as illustrated in Figures 7A to 7C together with a foam cover, as illustrated in any of Figures 4A to 6A and / or with a flange as illustrated in any of Figures 3A to 3C. Coupling devices Anchors / coupling devices (e.g. bases) according to exemplary embodiments of the invention are shown in Figures 9A to 16, and these may have a coiled shape. It is possible that certain coupling devices in an atrio-ventricular position may migrate further or deeper into the ventricle after deployment of the coupling device than desired. It may be beneficial to avoid too much base drop to help prevent paravalvular leaks, for example, sealing the docking device and prosthetic valve seal together higher up on the native leaflets may help prevent paravalvular leaks that could occur if more down in the chordae tendineae. Additionally, higher placement (e.g., by preventing base droop) may help the long-term stability of the valve, because the leaflets are thicker and more robust near the annulus rather than near its distal end. so anchoring at or near the ring is expected to be stronger and provide longer term stability. Additionally, greater placement of the prosthetic valve may help prevent abrasion of the valve against native tissue (e.g., against native leaflets and / or chordae tendineae), making the artificial valve less likely to rub against the valves. valves and / or chordae tendineae. Paravalvular leak can occur due to several causes, including when the native annulus is too large compared to the prosthetic valve; the commissural leaflets are too short and / or damaged; implantation of a docking device did not completely capture the native leaflets; crossing a coupling device from one side of the valve to the other causes a small gap (e.g. at the commissure); placement of a prosthetic valve is too biased toward the lateral, anterior, posterior, and / or medial sides of a native valve; and / or anatomical abnormalities in certain patients (e.g., clefts, those associated with degenerative mitral regurgitation, etc.). Various embodiments of this invention are designed to compensate, avoid, reduce and / or obviate many of these problems, including holding the base on both sides of the native mitral valve (thereby reducing and / or inhibiting base droop by maintaining the base and valve prosthetic valve near the plane of the native annulus), creating a better seal around a prosthetic valve, creating a better seal above the native annulus, etc. For example, Figures 9A-9C illustrate one version of the base or a core of the base configured to provide one or more points or regions of contact between the base and the wall of the left atrium, such as at least three points of contact in the left atrium or complete contact in the left atrial wall, while Figures 10A-10C illustrate a flat base or core of a flat base, where the atrial portion is in the mitral plane, and Figures 11A-11C illustrate a hybrid base or hybrid base core wherein the stabilizing loop or atrial creates a ring around a deployed prosthetic valve to seal the valve and reduce paravalvular leak. In the examples of Figures 9A to 11C, the coupling device 70 includes a coil or wound portion with a plurality of turns extending along a central axis of the coupling device 70. The coil or wound portion may be continuous and may generally extend in a helical manner, with various different sizes and sections, as described in more detail below. The coupling devices 70 shown in Figures 9A to 11C can be configured to fit in the mitral position but can be configured and / or adapted similarly or differently in other embodiments for better accommodation also in other positions of the native valve, just as in the tricuspid valve. Advantageously, the geometries of the coupling device of the present invention provide a coupling with the native anatomy that can provide greater stability and reduction of relative movement between the coupling device, the prosthetic valve coupled therein and the native anatomy. Reducing relative motion may prevent material degradation of the components of the coupling device and / or the prosthetic valve engaged therein and may prevent damage / trauma to native tissues. The coupling device 70 of many embodiments includes a central region 80 with a coil, a wound portion, or several coils (e.g., 2 coils, 3 coils, 4 coils, between 2 and 5 coils or more). The coiled portion or coils of the central region 80 may be of a similar size and shape or vary in size and / or shape. In some implementations, the central region 80 comprises three or about three complete coil turns having substantially equal inner diameters. The central region 80 of the coupling device 70 serves as the main landing region or clamping region for securing the expandable prosthetic valve when the coupling device 70 and the valve prosthesis are implanted in the body of a patient. In some embodiments, the coupling device 70 has a central region 80 with more or less than three coil turns, depending, for example, on the patient's anatomy, the amount of vertical contact desired between the coupling device 70 and the prosthesis. valve (e.g., transcatheter heart valve or THV) and / or other factors. The coiled portion or coil(s) of the central region 80 may also be referred to as functional coils or functional coils, as the properties of these coils contribute the most to the amount of retention force generated between the prosthetic valves. , the coupling device 70, and the native mitral leaflets and / or other anatomical structures. Several factors may contribute to the total retention force between the coupling device 70 and the prosthetic valve secured therein. A main factor is the number of turns included in the functional coils, while other factors include, for example, the inner diameter of the functional coils, the friction force (for example, between the coils and the prosthetic valve) and the resistance of the prosthetic valve and the radial force that the valve applies to the coil. A coupling device may have a variety of coils and / or turns. The number of functional turns may be in intervals from just over a half turn to 5 turns, or a full turn to 5 turns or more. In an embodiment with three full turns, an additional half turn is included in the ventricular portion of the coupling device. In another embodiment, there may be three complete turns in total in the coupling device. In one embodiment, in the auricular portion of the coupling device, there may be from one-half to three-quarters of a turn or from one-half to three-quarters of a circle. While a range of turns is provided, as the number of turns in a coupling device decreases, the dimensions and / or materials of the coil and / or the wire from which the coil is made may also change to maintain a strength. of adequate retention. For example, the diameter of the wire may be larger and / or the diameter of the functional coil turn(s) in a coupling device with fewer coils. There may be a plurality of coils in the atrium and ventricle. The size of the functional coils or central region coils 80 is generally selected based on the size of the THV desired to be implanted in the patient. Generally, the inner diameter 90 of the functional coils / turns (e.g., of the coils / turns of the central region 80 of the coupling device 70) will be smaller than the outer diameter of the heart valve expands, so that when the valve When the prosthetic valve expands in the docking device, additional radial tension or retention force will act between the docking device and the prosthetic valve to hold the prosthetic valve in place. The retention force necessary for proper implantation of a prosthetic valve varies according to the size of the prosthetic valve and the ability of the assembly to handle mitral pressures of approximately 180 mm Hg. 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 needed between the coupling device and the prosthetic valve to securely hold the valve. prosthetic valve in the docking device and to resist or prevent regurgitation or leakage of the valve. However, in this example, to meet this 15.8 N retention force requirement with statistical reliability, a target average retention force would need to be substantially greater, for example, approximately 30 N. In many embodiments, the retention force between the coupling device and the valve prosthesis is dramatically reduced when the difference between the outer diameter of the prosthetic valve in its expanded state and the inner diameter of the functional coils is less than about 5 mm. , as the undersized differential may be too small to create sufficient holding force between the components. For example, when, in one embodiment, a prosthetic valve with an expanded outer diameter of 29 mm was expanded into a set of coils with an inner diameter of 24 mm, the observed retention force was approximately 30 N, but when expanded the same prosthetic valve on a coil set with a 25 mm inner diameter (e.g., only 1 mm larger), the observed retention force was significantly reduced to only 20 N. Therefore, in some embodiments, to create sufficient retention force between the coupling device and a 29 mm prosthetic valve, the inner diameter of the functional coils (for example, the coils of the central region 10 of the coupling device 1) should be 24 mm or less. Often, the inner diameter of the functional coils (e.g., the central region 80 of the coupling device 70) must be selected to be at least about 5 mm smaller than the prosthetic valve being selected for implantation, although other functions and / or characteristics (e.g., friction-enhancing characteristics, material characteristics, etc.) can be used to provide better retention if other sizes or size ranges are used, as several factors can affect the retention force. However, the diameter of functional coils must be selected based on the consideration and balance of several factors for optimal results. For example, the native anatomy between the mitral annulus in the mitral plane and the heads of the papillary muscles forms a generally trapezoidal shape, and the tissue of the mitral leaflets is thickest near the mitral plane and thins more below the mitral plane. . The smaller diameters of the central region 80 may cause the coupling device 70 to be installed further below the mitral plane than is desirable (a similar effect can also be seen in the tricuspid valve). When docking occurs at a location where the mitral leaflets are thinner, this may result in a suboptimal anchoring position for the prosthetic valve. Consequently, size, diameters, and other features that help keep the prosthetic valve higher in the leaflets may be beneficial. Additionally, a size of the inner diameter of the functional coils or the central region 80 can also be selected to bring the native anatomy closer, in order to at least partially compensate or counteract valve regurgitation caused by stretching of the native valve, ring as a result of, for example, enlargement of the left ventricle. It is noted that the desired retention forces discussed above are applicable to modalities for mitral valve replacements. Therefore, other embodiments of the coupling device that are used for replacement of other valves may have different size ratios based on the desired retention forces for replacement of the valve in those respective positions. Furthermore, size differences may also vary, for example, depending on the materials used for the valve and / or coupling device, if there are other features to prevent expansion of the functional coils or to improve friction / locking. , and / or based on various other factors. In embodiments where the coupling device 70 is used in the mitral position, the coupling device may first be advanced and positioned on the annulus of the native mitral valve and then placed in a desired position, prior to valve implantation. prosthetic heart. In some embodiments, the coupling device 70 is flexible and / or made of a shape memory material, so that the coils of the coupling device WUUa / 2U21 / Ul 4200 coupling 70 can also be straightened for delivery via a transcatheter approach. In some embodiments, the coil is made of another biocompatible material, such as stainless steel. Some of the same catheters and other delivery tools can be used for both the delivery of the coupling device 70 and the prosthetic valve, without having to perform separate preparatory steps, simplifying the implantation procedure for the end user. Since the functional coils / turns or coils / turns of the central region 80 of the coupling device 70 are kept relatively small in diameter (for example, the central region 80 in one embodiment may have an internal diameter of between approximately 21-24 mm (e.g., ±2 mm) or other diameter smaller than the prosthetic valve and / or native annulus) to increase the retention force with the prosthetic valve, it may be difficult to advance the coupling device 70 around the existing leaflets and / or chordae tendineae to a desired position with respect to the native mitral annulus. This is especially true if the entire coupling device 70 is made to have the same small diameter as the central region 80. Therefore, the coupling device 70 may have a distal or lower region 82 that comprises and / or consists of a front coil / turn (sometimes called a surrounding loop or main ventricular loop / coil) of the coupling device 70, which has a bottom diameter that is greater than the diameter of the functional coils / turns or the region coils / turns center 80. The features of the native anatomy, especially in the right and left ventricles, have variable dimensions. For example, native mitral anatomy may have a maximum width of approximately 35 mm to 45 mm in a long axis. The diameter or width of the surrounding loop or main coil / turn (e.g., ventricular coil / turn) of the lower region 82 can be selected to be larger to more easily navigate a distal or forward tip 84 of the device. docking 70 around and surrounding features of native anatomy (e.g., leaflets and / or chordae tendineae). Various sizes and shapes are possible, for example, in one embodiment, the diameter could be any size between 25 mm and 75 mm. The term diameter, as used in this description, does not require that a coil / turn be a complete circle or perfectly shaped, but is generally used to refer to a greater width across opposite points of the coil / turn. . For example, with respect to the front coil / turn, the diameter can be measured from the distal tip 84 to the opposite side, such as if the lower region or the front coil / turn 82 formed a complete rotation, as shown as diameter 91 in Figure 9A. Alternatively, the diameter can be considered twice the radius of curvature of the main coil / turn. In various embodiments, the diameter 91 of the lower region 82 is sufficient to surround the anatomical features within the ventricle, including the mitral leaflets and chords, so that the internal diameter of the lower region 82 is equal to or greater than the internal diameter of the central region 80 (for example, the diameter 90 shown in Figure 10A). Other modalities are designed to be atraumatic to other ventricular anatomy, including the walls or septa within the ventricle. In this way, the diameter 91 of the lower region 82 is small enough not to come into contact with the walls or partitions. 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 of the coupling device 70 (e.g., the front coil / turn) has a diameter 91 of 43 mm or approximately 43 mm (e.g., ±2 mm), in other words, the radius of curvature in the front 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 coupling device 70 is in a range of 28-38 mm, 30-36 mm, 31-35 mm, 32-34 mm or 32.5-33.5 mm (e.g. radius of curvature in a range of 16.25-16.75 mm). Having an input coil / turn with a larger size than the functional coils can help to more easily guide the coils around and / or through the geometry of the chordae tendineae, and most importantly, appropriately around both native leaflets. of the native valve (e.g. native mitral valve, tricuspid valve, etc.) . Once the distal tip 84 is navigated around the desired native anatomy, the remaining coils of the docking device 70 can also be guided around the same features. In some embodiments, the size of the other coils can be reduced enough to cause the corralled anatomical features to be pulled radially inward or slightly radially inward. Meanwhile, the length of the enlarged lower region 82 or the main coil / turn can be kept relatively short, to prevent or avoid obstruction or interference of blood flow along the ventricular outflow tract through the lower region 82 or the main coil / turn. For example, in one embodiment, the enlarged lower region 82 or main coil / turn extends only about half a loop or rotation. With a lower region 82 or the front coil / turn having this relatively short length, when a prosthetic valve expands in the coupling device 70 and the coils of the coupling device 70 begin to unwind slightly due to the size difference between the coupling device and the prosthetic valve, the lower region 82 or the main coil / turn can also be inserted and moved slightly. In this example, after expansion of the prosthetic valve, the lower region 82 or main coil / turn may be of similar size and substantially aligned with the functional coils of the coupling device 70, rather than continuing to protrude from the coils. functional, reducing possible flow disturbances. Other embodiments of the coupling device may have bottom regions that are longer or shorter, depending on the particular application. In various embodiments, the coupling device 70 illustrated in Figures 9A to 110 also includes an enlarged proximal or upper region 86 comprising and / or consisting of a stabilizing coil / turn (e.g., which may be an atrial coil / turn). of the coupling device 70. During a transitional or intermediate stage of the implantation procedure, that is, during the time between the deployment and release of the coupling device 70 and the final delivery of the prosthetic valve, there is a possibility that the coil may be displaced and / or displaced from its desired position or orientation, for example, by regular cardiac function. Displacement of the coupling device 70 could potentially lead to less secure implantation, misalignment and / or other positioning problems of the prosthetic valve. A stabilization feature or coil can be used to help stabilize the docking device in the desired position. For example, the coupling device 70 may include the upper region 86 with an enlarged stabilization coil / turn (e.g., an enlarged atrial coil / turn having a diameter 92 and / or 94 larger than the functional coils) intended to be placed in the circulatory system (for example, in the left atrium) so that it can stabilize the coupling device. For example, the upper region 86 or the stabilization coil / turn can be configured to rest or push against the walls of the circulatory system (for example, against the walls of the left atrium), in order to improve the ability of the device to coupling 70 to remain in the desired position before implantation of the prosthetic valve. The stabilization coil / turn (e.g., atrial coil / turn|) in the upper region 86 of the coupling device 70 in the embodiments shown may extend up to approximately one full turn or rotation, and terminates in a proximal tip 88. In other embodiments, In embodiments, the stabilization coil / turn (e.g., atrial coil) may extend for more or less than one turn or rotation, depending, for example, on the amount of contact desired between the coupling device and the circulatory system (e.g. , with the walls of the left atrium) in each particular application. The radial size of the stabilization coil / turn (e.g., atrial coil) in the upper region 86 may also be significantly larger than the size of the functional coils in the central region 80, so that the stabilization coil / turn ( for example, atrial coil or atrial loop) widens or extends outward enough to contact the walls of the circulatory system (for example, the walls of the left atrium). Additionally, the stabilization coil / turn of various modalities will be configured to be less abrasive to native tissue and / or anatomy. For example, the surface texture may be smoothed and / or smoothed, so that movement of the docking device against the native anatomy does not damage the native tissue. The proximal tip 88, as shown in these figures, also includes an eye-shaped eyelet or hole. The eyelet in the proximal tip will be used to secure the coupling device 70 to a delivery system (as described below) through various means, including a suture. Thus, various embodiments comprising an eyelet at the proximal tip 88 will use different shapes and sizes of eyelets. Thus, some modes will use larger eyelets, while other modes will use smaller eyelets. Furthermore, the shape will vary in certain embodiments, so that some embodiments will have round eyelets, while others will use D-shaped eyelets. In addition, several embodiments will not have eyelets as illustrated, but will have holes drilled in the coupling device itself, such as laser drilled holes. Turning to Figures 9A to 9C, these figures are representative of a coupling device, but are also representative of a core that can be covered and / or added to form a coupling device. The stabilization coil 86 is designed to create a plane formed by at least three contact points in the atrium. These three anchor points or contact points are the posterior shelf of the native valve (e.g., mitral valve, etc.), the anterior wall of the atrium, and an atrial appendage of the atrium or the lateral shelf of the valve. native. This plane formed by three points of contact will be parallel to a plane of the native valve, which will maintain the position of the base parallel to the plane of the native valve. In some embodiments, the diameter of the stabilization coil / UI is desirably larger than the annulus, the plane of the native valve and the atrium for better stabilization, but the stabilization coil is flexible with a thin and weak cross section to avoid damage to a patient's atrium after long-term placement of the docking device 70. Suitable materials for the coupling device include a nitinol core with a core size in the range of about 0.3 mm to about 1 mm. The flexible core will allow the stabilization coil to adapt to different shapes and sizes of atria. Furthermore, in some embodiments with a three-point contact design as illustrated in Figures 9B and 9C, the stabilization coil is designed, when not restrained (for example, when not installed on the patient's native valve), to sit lower in clearance than the functional coils or cross down through the functional coils. This can beneficially raise the functional coils (central region 80) relative to the native anatomy, a plane of the native valve and leaflets when implanted. For example, a stabilization coil crossing from a proximal side of the central region or functional coils in the direction or towards a distal side of the central region / functional coils, when deployed in an atrium, pushes down into the atrium and / or or the plane of the native valve to cause the central region / functional coils to move upward or deflect upward on the ventricular side of the valve and higher beneath the leaflets. With respect to Figures 10A to 10D, these figures are representative of a coupling device, but are also representative of a core that can be covered and / or added to form a coupling device. In Figures 10A-10D, the coupling device 70 is designed to have a planar stabilization coil 86 that sits in a plane of the native valve (for example, in a native mitral plane or a native tricuspid plane). In these embodiments, the stabilization coil 86 is designed to be larger than the opening of the native valve (e.g., of the mitral valve or tricuspid valve), but not so large that the stabilization coil 86 does not seat. in a plane of the native valve. The stabilization coil 86 can form a continuous curve, as illustrated in Figure 10A or it can widen or tilt towards the rear wall of the atrium, as seen in Figure 10B, thus taking advantage of the rear shelf, to prevent the coupling device 70 falls into the ventricle prior to deployment of an artificial or prosthetic valve therein. Additionally, in certain planar embodiments, the stabilization coil will have a smooth cover to avoid trauma to the native anatomy in regions that exhibit relative motion (for example, where the coupling device 70 crosses from the atrium to the ventricle through the mitral valve). Turning to Figures 11A to 11C, these figures are representative of a coupling device, but are also representative of a core that can be covered and / or added to form a coupling device. In Figures 11A to 11C, a hybrid spring design is illustrated that is configured to improve the prevention and / or inhibition of paravalvular leaks. In embodiments of this hybrid coupling device 70, the stabilization coil 86 is designed to create a closer ring around a deployed prosthetic valve, thereby helping to seal the valve and preventing paravalvular leaks. In some embodiments, this sealing effect is maximized by radially displacing the spring core outward from the maximum outside diameter of the valve plus half the cross section of the coupling device. In some embodiments, the stabilization coil 86 allows for the larger outside diameter (e.g., optimal contact with the atrium) to also assist with spring decay prior to deployment of the prosthetic valve. Furthermore, in some embodiments, the coupling device is configured such that, after deployment of the prosthetic valve, the stabilization coil will be flush with the outer diameter of the implanted and expanded prosthetic valve. This hybrid design can be manufactured to rely on different prosthetic valve outer diameters to prevent paravalvular leaks near the prosthetic valve. For example, the coupling device may be designed to accommodate a valve with an outer diameter of about 30 mm or about 34 mm or any diameter in between. Additionally, the dimensions of the coupling device 70 can be adjusted to handle prosthetic valves with outside diameters ranging from about 20 mm to about 50 mm. In some embodiments, the various coupling devices herein are configured to have a small enough cross section during delivery to fit within a catheter / cuff / sheath of a delivery device (discussed in more detail below), but expand after deployment to maximize the outside diameter and create an improved seal around a prosthetic valve after implantation. Additionally, some embodiments comprise and / or use a material configured to optimize tissue ingrowth (e.g., with pores and / or other openings sized to provide more available surface area to help stimulate such ingrowth). . In some embodiments, the sizes of the pores and / or openings are approximately 30 µm - 1000 µm, which may promote optimal tissue growth. Tissue ingrowth may allow for an improved seal and better integration with the native valve anatomy to stabilize the docking device and prosthetic valve and prevent abrasions and / or damage over time. In certain embodiments, the coupling devices may comprise a material having openings (e.g., pores) with sizes in a range of about 400-800 pm, 500-750 pm, 500-660 pm, 600-650 pm or 625-600 pm. 650 pm. The various coupling devices herein may also incorporate additional modifications to the functional coils (e.g., central region 80 in Figures 9A to 11C) and / or the stabilization coil (e.g., element 86 in Figures 9A to 11C) to improve the functionality of the coupling devices. Examples of some of these additional modifications are illustrated in Figures 12A to 16. Figures 12A to 12G illustrate examples of possible covers 100 that may be placed on all or only a portion of a coupling device (for example, the coupling device 70 as illustrated in Figures 9A to 11C or elsewhere herein). document) to form a seal against the prosthetic valve and reduce paravalvular leak. In many embodiments, the cover 100 covers predominantly or only the stabilization loop / coil (e.g., the atrial coil / coil) or a portion thereof. In some embodiments, the cover 100 is secured to the atrial loop and extends toward the functional loops in the central region and / or over a portion of the functional loops. In some embodiments, the cover 100 is secured to the functional loop and extends toward the atrial loop. Certain modalities have cover 100 only on the functional turns. In some embodiments, the cover 100 extends over the entire coupling device 70. When on the stabilization coil / turn or the atrial coil / turn, the cover 100 may help cover an atrial side of an atrioventricular valve to prevent and / or inhibit blood leakage through the native leaflets, commissures, and / or around the outer portion of the prosthetic valve by blocking blood in the atrium from flowing in an atrial-to-ventricular direction other than through the prosthetic valve. In some embodiments, the cover 100 is configured to have a compressed configuration for delivery through the vasculature to the heart valve with a narrow profile and an expanded configuration in which the cover 100 expands to a larger outer diameter (which may beneficially help prevent and / or inhibit paravalvular leak). In some embodiments, the cover 100 may expand to a diameter of approximately 5 mm (e.g., ±4 mm) to prevent and / or inhibit paravalvular leak. In some embodiments, the cover 100 is configured to expand so as to form an improved seal closer to and / or against a prosthetic valve deployed therein (as described above with respect to Figures 11A to 11C). In some embodiments, the cover 100 is configured to prevent and / or inhibit leaks at the location where the coupling device 70 crosses between the native valve leaflets (e.g., without cover 100, the coupling device may separate the leaflets). at the crossing point of the leaflets and allow leakage at that point (e.g., along the coupling device or at its sides), but the cover 100 can be configured to expand to cover and / or fill any opening at that point and inhibit leaks along the coupling device). In some embodiments, for example, as illustrated in Figure 12A, the cover 100 may comprise and / or consist of an expandable foam. In some embodiments, the cover comprises and / or consists of an expandable foam that is a viscoelastic foam, such that it will expand to a specific shape or a specific preset shape upon removing a crimping pressure prior to delivery of the coupling device 70. Examples of such foams are polyethylene terephthalate (PET), polyurethane, and polyurethane-polycarbonate matrix. In some embodiments, the foam is configured to expand the cross-sectional diameter of the coupling device 70, so that the cross-sectional diameter in the cover region is 2 mm to 7 mm. Furthermore, in some embodiments using foam, the foam comprises pores large enough to be atraumatic to the native anatomy and allow ingrowth of tissue. In some embodiments, the cover 100 comprises a foam-free expandable structure over the coupling device 70. For example, as illustrated in Figure 12B, the cover 100 may comprise a braided structure over the coupling device 70. A braided structure It may be stretched within a sleeve or cover prior to deployment of the coupling device 70, but after deployment, the braided structure may be allowed to expand to its largest possible diameter to create a seal. In some embodiments, the braided structure is a shape memory braided material (e.g., shape memory alloy, shape memory metal, nitinol, etc.) that is configured and / or preconfigured to expand to a shape and / or or particular size when unrestricted and when deployed on a native valve. In Figure 12C, in some embodiments, the cover 100 comprises several layers of the same and / or different materials. In these embodiments, the cover (such as a braided structure, foam, or non-foam expandable structure) may be covered with a second cover 102. In these embodiments, the second cover 102 is designed to be atraumatic to native tissue and / or promote growth. of fabric towards the interior of the second cover 102 and possibly the first cover 100. The second cover can be constructed of any suitable material, including foam, cloth, fabric and / or polymer, that is flexible to allow compression and expansion of the first 100 and second 102 covers. Movement between a coupling device 70 and a cover 100 can cause trauma to native tissue, and thus, various embodiments of coupling devices 70 will incorporate means to limit movement, thereby reducing the risk of trauma to native tissue. Turning to Figure 12D, an embodiment of a coupling device covered with a braided stabilization coil 86 is illustrated. In embodiments such as those illustrated in Figure 12D, a braided texture on the spring stabilization coil 86 may interact with the cover. 100 surrounding the stabilization coil 86. By forming an interaction between the stabilization coil 86 and the cover 100, movement of the coupling device 70 can be reduced, therefore limiting trauma to the native tissue. In Figure 12E, an embodiment of a coupling device 70 with a cover 100 on a functional coil in the central region of the coupling device is illustrated. As the example illustrated in Figure 12B, the cover 100 may comprise a braided structure over the coupling device 70. A braided structure may be stretched within a sleeve or cover before deployment of the coupling device 70, but after deployment, The braided structure can be allowed to expand to its largest possible diameter to create a seal. In some embodiments, the braided structure is a shape memory braided material (e.g., shape memory alloy, shape memory metal, nitinol, etc.) that is configured and / or preconfigured to expand to a shape and / or or particular size when unrestricted and when deployed on a native valve. As shown in Figure 12E, the coupling device 70 may have an extension 140 positioned substantially between the central region 142 having the functional loops and the upper region 144 having the atrial loop. As described elsewhere herein, the coupling device 70 may have a lower region 146 that has a surrounding turn with a larger diameter with respect to the functional turns in the central region 142. In Figure 12E, the extension 140 consists of or includes a vertical part of the coil that is MA / a / 2U21 / Ul 4203 extends substantially parallel to a central axis of the coupling device 70. In some embodiments, the extension 140 may be inclined with respect to the central axis of the coupling device 70, but will generally serve as a vertical spacer or axial separating the adjacent connected portions of the coupling device 70 in a vertical or axial direction, so that a vertical or axial space is formed between the parts of the coil on each side of the extension 140 (for example, a space between an upper or atrial side and a lower or ventricular side of the coupling device 70). In certain embodiments, the extension 140 is intended to be placed at or near the anterolateral commissure AC when the coupling device 70 is implanted, with the cover 100 crossing the plane of the mitral annulus and positioned so that a portion of the cover 100 is place in the posteromedial commissure PC. Additional details of exemplary shapes for the coupling device 70 having an extension 140 can be seen in United States pre-grant publication number US2018 / 0055628A1, the entirety of which is incorporated herein for all purposes. Turning to Figure 12E, an embodiment of a coupling device 70 is illustrated with a cover 100 extending into the upper functional turn of the central region. In such embodiments, the cover 100 can help cover the 100 ventricular side of an atrioventricular valve to prevent and / or inhibit blood leakage through the native leaflets, commissures and / or around the outside of the prosthetic valve by blocking blood flow in the atrium in one direction atrial to ventricular other than through the prosthetic valve. As the example illustrated in Figure 12B, the cover 100 may comprise a braided structure over the coupling device 70. A braided structure may be stretched within a sleeve or cover before deployment of the coupling device 70, but after deployment, The braided structure can be allowed to expand to its largest possible diameter to create a seal. In some embodiments, the braided structure is a shape memory braided material (e.g., shape memory alloy, shape memory metal, nitinol, etc.) that is conformed and / or preconfigured to expand to a shape and / or or particular size when unrestricted and when deployed on a native valve. In some embodiments, the cover 100 is secured to the atrial loop and extends toward the functional loops in the central region and / or over a portion of the functional loops. In some embodiments, the cover 100 is secured to the functional loop and extends toward the atrial loop. In additional embodiments, the cover 100 may be attached to the core of the coupling device at both ends of the cover 100 and have a floating portion. WUUa / 2U21 / Ul 4200 101 between them. Additionally, the cover 100 may comprise and / or consist of an expandable foam. In some embodiments, the cover comprises and / or consists of an expandable foam that is a viscoelastic foam, such that it will expand to a specific shape or a specific preset shape upon removing a crimping pressure prior to delivery of the coupling device 70. , such as the example in Figure 12A. Figures 12F and 12G illustrate different arrangements of the various components that may be integrated in or around the stabilization coil 86 in many embodiments. In particular, Figure 12F illustrates a cross section of the stabilization coil 86 together with the cover 100 and the second cover 102. As illustrated, as the cover 100 and the second cover 102 expand, a cavity 104 is formed. between the stabilization coil 86 and the covers 100, 102. Also illustrated are the construction of the atrial coil that includes a core 106, which may be, for example, a NiTi core, or a core that is made of or includes one or more of various other biocompatible materials. Figure 12F also illustrates the tubular layer 108 to provide a padded-type cushioning layer to make the atrial loop atraumatic against native tissue. In certain embodiments, the tubular layer 108 is constructed of ePTFE. Figure 12F further illustrates the 102 braided layer 110 placed over tubular layer 108. As noted above, braided layer 110 is designed to interact with cover 100 to limit movement and / or limit trauma to native tissue. It should be noted that Figure 12F illustrates a variety of options that can be used in the construction of coupling devices of various embodiments, and the particular arrangement is only illustrative of some embodiments. Thus, various embodiments will not have all of the components illustrated in Figure 12F in the construction of a coupling device. In some embodiments, the cross section of Figure 12F can be implemented in the coils shown in Figures 12B-12D. Furthermore, in some embodiments, the stabilization coil 86 may have two portions, a first portion with the cross section shown in Figure 12F and an adjacent second portion having a cross section shown in Figure 12G. The cross section shown in Figure 12G may be the same as the cross section shown in 12F, except that it does not include the braided layer 110. In some embodiments, such as shown in Figure 12E, the coverage area 100 can be divided into two portions (as indicated by the dashed line), including a first portion extending in the direction of arrow 12F and a second portion extending in the opposite direction, as shown with arrow 12G. The first 103 portion may have the cross section shown in Figure 12F, while the second portion may have the cross section shown in Figure 12G. In certain embodiments, the first portion having the cross section shown in 12F may have a total cross section diameter smaller than the total cross section diameter of the second portion having the cross section shown in Figure 12G. A potential advantage of these modalities is a reduced potential for LVOT obstruction due to the reduced cross-sectional diameter of a portion of the sheaths 100, 102 that are present in the left ventricle beneath the anterior leaflet. Figure 12H illustrates a circumferential section 130 around the mitral annulus generally illustrating exemplary ranges of coverage 100 that may be included in certain embodiments of the coupling device 70. Figure 12H is a plan view of the mitral valve with the rear facing down and the previous one up. In a healthy heart, the mitral valve annulus MV creates an anatomical shape and tension such that a posterior leaflet PL and an anterior leaflet AL fit into the inflow orifice, forming a tight junction, at peak contraction or systolic pressures. , as seen in figure 12H. The MV annulus of the mitral valve has a posterior surface to which the posterior leaflet PL is attached and an anterior surface to which the leaflet PL is attached 104 previous AL. The part where the leaflets join on the opposite medial and lateral sides of the annulus is called the leaflet commissures: the anteriorolateral commissure AC and the posteromedial commissure PC. The posterior leaflet is divided into three festoons or cusps, sometimes identified as Pl, P2, and P3, starting from the anterior commissure and continuing counterclockwise to the posterior commissure. The posterior festoons Pl, P2, and P3 circumscribe particular arcs around the periphery of the posterior aspect of the annulus, which can vary according to a variety of factors, including the actual measurement of the scallops of the posterior leaflet of the mitral valve and the surgeon preference. However, as a rule, a major axis 122 of the mitral annulus intersects both the first and third posterior festoons Pl and P3, approximately at the commissures AC, PC, and a minor axis 124 intersects and generally bisects the middle posterior festoon P2. The anterior leaflet also presents festoons or regions labeled Al, A2 and A3 as indicated in Figure 12H. The anterior mitral leaflet AL attaches to the fibrous portion FA of the mitral annulus, which constitutes approximately one-third of the total circumference of the mitral annulus. The muscular portion of the mitral annulus constitutes the rest of the mitral annulus and the posterior leaflet PL is attached to it. The anterior annulus fibrosus FA, the two ends of which are called fibrous trigones T, is part of the central fibrous body of the heart. The anterior commissure AC and the commissure 105 posterior PC are located just behind each fibrous trigone. The annulus fibrosus of the FA mitral valve is intimate or adjacent to the AV aortic valve, particularly the LCS of the left coronary sinus and the NCS of the noncoronary sinus. The central fibrous body is quite resistant to elongation and therefore the vast majority of mitral annulus dilation occurs in the posterior two-thirds of the annulus or around the muscular mitral annulus. The cover 100, with or without additional cover 102, can be provided on the coupling device 70 with a desired length at the time of implantation having a circumferential span 130. In some embodiments, the cover 100 can extend from a first location radial angular 134 in the left ventricle, through the CP and into the left atrium, and to a second radial angular location 136 in the left atrium. In Figure 12H, the first angular location 134 is shown at a point between the PC and the AC, but in other implementations, the circumferential section 130 may extend further around the ring toward or beyond the AC, or may extend less than a radial angle around the ring as shown as an example of angular location 138 in Figure 12H. The first radial angular location may be in one of several locations with respect to the anatomy of the mitral annulus in various modalities after implantation. In some In 106 embodiments, the first radial angular location 134 may be at a radial angular location corresponding to a point on Al, a point on A2, or a point on A3. In certain embodiments, after implantation, the first radial angular location 134 is below the A2 region of the AL, which may provide an advantage of reducing the risk of LVOT obstruction. In some embodiments, the first angular location 134 is selected to avoid overlap with the adjacent aortic valve structures of the LCS of the left coronary sinus and the NCS of the non-coronary sinus. In other embodiments, the first radial angular location 134 may be at a point representing a percentage of the circumferential distance from the PC to the AC (counterclockwise in Figure 12H), of approximately 10%, about 20%, about 30%, about 40%, about 50% (approximately in the middle of A2 at about a point intersected by the minor axis 124), about 60%, about 70%, about 80%, about 90% or about 100% (approximately in the AC). The second radial angular location 136 may be in one of several locations with respect to the anatomy of the mitral annulus in various embodiments after implantation. In some embodiments, the second radial angular location 136 may be at the radial angular location 132 at or near / UI 107 the AC. In other embodiments, the second radial angular location 136 may be at a point on Pl, at a point on P2, or at a point on P3. In still other embodiments, the second radial angular location 136 may be at a point representing a percentage of the circumferential distance of the PC to the AC (clockwise as shown in Figure 12H), of approximately 10%, approximately 20%, approximately 30%, approximately 40%, approximately 50% (approximately in the middle of P2 at approximately point intersected by the minor axis 124), approximately 60%, approximately 70%, approximately 80%, approximately 90 % or approximately 100% (over the AC). In other embodiments, the cover 100 may extend to the radial location 132 of the AC and upward over a portion of the extension 140 of the coupling device 70 that extends into the left atrium. In certain embodiments, the first radial angular location 134 and the second radial angular location 136 may be selected so that the cover 100 forms a complete circumferential span around the MV. In some embodiments, both radial angular locations 134, 136 may be on or near the AC. In certain embodiments, the first radial location 134 can be selected so that the cover portion 100 in the left ventricle extends counterclockwise, as seen in the figure 108 12Η, beyond the second radial angular location 136 so that the cover 100 is implanted with a total radial angular length more than one full circumference of the MV. In some embodiments, a sleeve or sleeve is provided to prevent the cover 100 from expanding until the docking device 70 is deployed. This additional sleeve or sleeve may be integrated into a delivery system and / or delivery device (e.g., as will be described below with reference to figures 17A20D, 22A-22C, 24A-24B and 33-34). In some embodiments, the sheath or sleeve may be a biodegradable or bioabsorbable material, such that the sheath or sleeve degrades over a period of time after deployment without additional requirements in manufacturing a delivery device or in the user removing the cover or sleeve. In these cases, the sleeve or manqa may be more of a coating over the cover. In embodiments using a bioabsorbable sheath, the material may be designed to biodegrade for a period of time sufficient to allow deployment and / or redeployment of the coupling device 70 and / or a prosthetic valve without obstructing the work of a physician, surgeon, or another medical professional who deploys the coupling device 70 or a prosthetic valve. In some embodiments of coupling devices with covers 100, as illustrated in the 109 figures 12A to 12G, the jacket is made of braided NiTi, braided NiTi covered with braided PET, braided NiTi covered with woven PET, braided NiTi covered with woven PET, braided NiTi covered with ePTFE membrane, braided NiTi covered with electrospun ePTFE, Braided NiTi dipped in an elastomer, Braided NiTi sprayed with an elastomer, NiTi braided between thermally compressed layers of thermoplastic membranes, foam, PET braid, PET woven fabric, PET knitted fabric, braided materials composed of NiTi and PET yarns , braided materials composed of NiTi and PET yarns covered with one or more of braided PET, woven PET, knitted PET, ePTFE membrane, electrospun ePTFE, braided composite materials with NiTi and PET yarns dipped or sprayed with an elastomer, composite materials braided with NiTi and PET threads between thermally compressed layers of thermoplastic membranes, or combinations thereof. In certain embodiments, the composite braided materials may comprise a braided composite having 48 yarn ends, with 30 of the yarn ends comprising PET and 18 of the yarn ends comprising NiTi. In other embodiments, the shell 100 can be impregnated with growth factors to stimulate or promote tissue growth, such as transforming growth factor alpha (TGF-alpha), transforming growth factor beta (TGF-beta), growth factor of basic fibroblast factor (bFGF), 110 vascular epithelial growth (VEGF) and combinations thereof. The various coupling devices herein may comprise interlocking or braided textures or coatings on various surfaces of the coupling device. For example, coupling devices with a woven or braided texture or coatings in the central region or on the functional coils can beneficially help increase friction between the coupling device, the native anatomy, and / or the prosthetic heart valve when The prosthetic heart valve is deployed in the docking device, which may help improve retention forces. This can also provide more surface area for tissue growth. While these textures provide benefits such as better retention force for prosthetic valves, the texture can also cause unwanted friction on the native anatomy while the docking device is placed on the native valve, which can slow deployment of a coupling device and / or cause damage to native anatomy. In some embodiments, the woven or braided textures or cover are part of and / or secured firmly against the outer wall of the coupling device to maintain a low profile and secure location. In some embodiments, the textures or coatings 111 woven or braided fabrics comprise an ePTFE cover and / or a PET cover. Figures 13A to 13C show schematic and cross-sectional views of a portion of an example coupling device configured to enhance retention forces between the coupling device and a replacement valve. Figure 13A illustrates three-turn portions of a coupling device 70 (such as the central region 80) are illustrated, while Figure 13B illustrates a cross-sectional view of a coupling device 70. The coupling device 70 includes a main coil or core 1102, which may be, for example, a NiTi coil / core, or a coil / core that is made of or includes one or more of various other biocompatible materials. The coupling device 70 further includes a cover 1104 that covers the coil / core 1102. The cover 1104 may be made of or include a high friction material, so that when the valve expands it expands in the coupling device 70. , a greater amount of friction is generated between the valve and the cover 1104 to maintain a shape of the coupling device 400 and prevent or inhibit / resist the coupling device 70 from unwinding. In some embodiments, the cover also alternatively increases the amount of friction between the coupling device and the leaflets. 112 native and / or the prosthetic valve to help retain the relative positions of the coupling device, the leaflets and / or the prosthetic valve. In some embodiments, the cover 1104 is made of one or more high friction materials that are placed over the wire / core 1102 of the coil. In some embodiments, the cover 1104 is made of or includes a PET braid. In additional embodiments, the cover 1104 is made of or includes a PET braid over an ePTFE tube (e.g., 1106, Figure 13C), the latter of which serves as a core for the cover 1104. The ePTFE tube is porous , providing a padding-type cushioning layer for the struts or other portions of an expandable valve frame for digging, improving the coupling between the valve and the coupling device 70. Meanwhile, the PET layer provides additional friction against the leaflets of the native valve when the prosthetic valve expands, and the struts or other parts of the valve frame apply outward pressure on the coupling device 70. These features can work together to increase the radial forces between the coupling device 70 and the native leaflets and / or the prosthetic valve, therefore also increasing the retention forces and preventing the coupling device 70 from unwinding. In other embodiments, the cover 1104 may be 113 made of one or more other high friction materials that cover the coil 1102 in a similar manner. The material or materials selected to manufacture the cover 1104 may also promote rapid tissue growth. Additionally, in some embodiments, an outer surface of a replacement valve frame may also be covered with a fabric material or other high friction material to further increase the friction force between the coupling device and the valve, reducing or further preventing the docking device from unwinding. The friction provided by the sheath may provide a coefficient of friction greater than 1. The sheath may be made of ePTFE and may be a tube that covers the coil and may be smooth or may have pores (or be braided or have other structural features that provide a larger accessible surface area as do pores) to stimulate tissue growth. The cover may also have a PET braid over the ePTFE tube when the ePTFE tube is smooth. The outermost surface of the sheath or braid over the sheath may be any biocompatible material that provides friction, such as a biocompatible metal, silicone tubing, or PET. The size of the pores in the cover can range from 30 to 100 microns. In embodiments where there is a PET cover on top of the ePTFE, the PET layer can only be bonded to the ePTFE cover and not directly to the coil of the 114 coupling device. The ePTFE tube cover can be attached to the coil of the docking device at the proximal and distal ends of the covers. The ePTFE tube cover can also be laser welded to the coil, or stamped to hold them in place to the coil, including the use of radiopaque markers placed on the outside of the ePTFE tube cover or a PET braid such as stamping material. Cover 1104 may be added to any of the coupling devices described herein and may cover all or a portion of the coupling device. For example, the cover may be configured to cover only the functional coils, the main coil, the stabilization coil, or only a portion of one or more of these (e.g., only a portion of the functional coils). Figures 14A to 14C illustrate embodiments that use a soft and / or smooth cover 1200 on the core 1202 of a coupling device to reduce friction while maintaining retention forces for a prosthetic valve. In certain embodiments, the soft cover 1200 is expanded polytetrafluoroethylene (ePTFE), but other materials are also possible. In Figure 14A, the core 1202 is surrounded by two layers, which may be two layers of ePTFE. The outer layer 1204 may be a low density ePTFE that allows a prosthetic valve to be embedded in the ePTFE, 115 thus providing a retention force for the prosthetic valve. Additionally, the inner layer 1206 may be a higher density ePTFE that prevents tearing and bunching of the ePTFE at the distal and proximal ends of a coupling device during deployment (e.g., elements 21 and 31, Figures 9A to 11C). . An exemplary lower density ePTFE may be an ePTFE with approximately 0.2 g / cm3. An example of a higher density ePTFE may be an ePTFE with approximately 1.3 g / cm3, 1.4 g / cm3, 1.5 g / cm3, 1.6 g / cm3, 1.7 g / cm3, 1.8 g / cm3, 1.85 g / cm3, or 1.9 g / cm3. cm3. In some embodiments that use a soft and / or smooth 2-layer cover, the core diameter will be approximately 0.84 mm (e.g., +0.5 mm), while some embodiments will have a core diameter of at least 0.83 mm. Additionally, the outer diameter of the inner layer 1206 of some embodiments will be approximately 1.34 mm (e.g., +1 mm). Additionally, the outer diameter of the outer layer 1104 will be 3.1 mm (e.g., +1 mm). In certain embodiments, the outer diameter of the outer layer 1204 will not be greater than 3.1 mm. In some embodiments, a soft and / or smooth cover uses a 3-layer method, as illustrated in Figure 14B. In the 3-layer example, an ePTFE interlayer 1208 has an ePTFE interlayer between the inner layer 1206 and the outer layer 1204. In some embodiments, the interlayer 1208 will use an ePTFE with a higher density than 116 the outer layer 1204 but lower density than the inner layer 1206. For example, a 3-layer embodiment as illustrated in Figure 14B may have an outer layer 1204 of approximately 0.2 g / cm3 of ePTFE, an inner layer 1206 of ePTFE having a density of between about 1.3 g / cm3 and about 1.9 g / cm3, and an interlayer 1208 using ePTFE having a density of between about 0.2 g / cm3 and about 1.9 g / cm3. In some embodiments using a soft and / or smooth 2-layer cover, the core diameter will be approximately 0.84 mm (e.g., +0.5 mm), while some embodiments will have a core diameter of at least 0.83 mm. Additionally, the outer diameter of the inner layer 1206 of some embodiments will be approximately 1.34 mm (e.g., +1 mm). Additionally, the outer diameter of the intermediate layer 1208 in some embodiments will be approximately 1.62 mm (e.g., +1 mm), while the outer diameter of the outer layer 1204 will be 3.1 mm (e.g., +1 mm) in various modalities. In some embodiments, the outer diameter of the outer layer 1204 will not be greater than 3.1 mm. Some embodiments comprising multiple layers of ePTFE to create a soft and / or smooth cover will have the layers bonded together along the entire length of the cover and / or coupling device. However, additional embodiments will use an intermittent binding pattern to 117 increase the gumminess of the coating, as illustrated in Figure 14C. Figure 14C shows the length of the coupling device with a smooth and / or soft cover. The joint 1210 is shown in various positions along the length of the soft cover 1200. The distance between the joint can be every 5 mm, 8 mm or 12 mm in various embodiments. In some embodiments, the joining can be carried out at variable distances to adjust the properties along the coupling device. The functional coils of the coupling devices of the present invention may be similar or the same in size and shape or may vary in size and / or shape. Turning to Figures 15A to 15D, variations of the functional coils of the coupling device 70 are illustrated. In Figures 15A and 15B, the central region 80 has a generally hourglass shape in the functional coils, so that the coils Functional devices have a larger inner diameter at the inlet portion 1302 and outlet portion 1304 of the central region 80 with a smaller inner diameter at the medial position 1306. In contrast, Figures 15C and 15D illustrate a central region 80 that It has a generally barrel shape having a larger internal diameter in the medial position 1306 and smaller internal diameters in the inflow portion 1302 (e.g., atrial or proximal) and the outflow portion 1304 (e.g. , WUUa / 2U21 / Ul 4200 118 ventricular or distal). The hourglass and / or barrel designs of Figures 15A to 15D, respectively, may allow for better flushing of the prosthetic valve leaflets, which may help prevent thrombus formation. The hourglass and barrel shapes of Figures 15A to 15D can be formed in various ways, including forming the coupling device 70 with a uniform cross section from the proximal tip 88 to the distal tip 84, but the shape of the region Central 80 maintains the hourglass or barrel shape illustrated in Figures 15A to 15D, respectively. Another method of creating these shapes is to vary the cross section from the proximal tip 88 to the distal tip 84, so that the inner diameter in the central region 80 has hourglass or barrel shapes. Furthermore, the number of functional coils can be increased to form the hourglass or barrel shapes of Figures 15A to 15D. For example, some embodiments of the hourglass shape will use a 3-coil central region 80 (as illustrated in Figure 15A), where the most distal and proximal functional coils have the largest inner diameter, while the intermediate coil has a relatively smaller inner diameter, while other embodiments may use a central region 80 of 5 coils (as illustrated in Figure 15B), while other embodiments will use 7 or more coils in the central region 80 with changes further 119 gradual in the internal diameter between the largest diameters of the most proximal and distal functional coils and the intermediate coil. Conversely, barrel shape embodiments will use a similar number of coils as described for the hourglass shape, including a 3-coil shape (Figure 15C), a 5-coil shape (Figure 15D), or 7 or more coils; however, it should be noted that the cylinder shape will increase the internal diameter of the intermediate coils relative to the more distal and proximal functional coils. Furthermore, these 3, 5, and 7 coil examples are merely illustrative and should not be construed to limit the number of coils to odd numbers of coils or to limit them solely to these examples. In some embodiments, the coupling devices herein may further incorporate a tab 1402 on the stabilization coil of the coupling device 70, as shown, for example, in Figure 16. In Figure 16, the stabilization coil 86 has textile or other fabric connected to the next adjacent loop 1404 in the central region 80. This fabric will act as a flange 1402 to reduce paravalvular leak and / or increase the amount of blood flowing through a prosthetic valve. In some embodiments, the various coupling devices herein include one or more radiopaque markers along the length of the coupling device. 120 coupling. For example, a radiopaque marker may be placed at the distal tip of some embodiments, and some embodiments will include a radiopaque marker at a location approximately one-quarter turn across the coils of the coupling device. Additional embodiments include a plurality of radiopaque markers located at positions along the coupling device. For example, radiopaque markers could be placed every 25 mm, 29 mm, 30 mm, 34 mm or more, which could be used by a medical professional to identify the amount of expansion in the diameter of the functional turns, such as when a valve prosthetic is subsequently deployed into the docking device. Radiopaque marker bands can be laser welded to the coil, or radiopaque markers can be placed on the outside of the ePTFE tube jacket or PET braid and stamped into the materials to hold them in place on the coil. It should be noted that various embodiments will encompass multiple features, such as those described with reference to Figures 12A to 16 and all combinations of these features are contemplated herein, unless certain features are mutually exclusive and / or cannot be physically combined ( for example, a coupling device having the hourglass and barrel shapes of Figures 15A to 15D). Furthermore, while the 121 stabilization coil / turn and atrial coil / turn are used simultaneously or interchangeably herein, it should be noted that the coupling device may also be used in other locations, where similar shapes would be beneficial, and the Use of these terms is not intended to limit the use of the modalities described in this document for atrial deployment. Supply system Certain embodiments are directed to delivery systems and / or devices for delivering anchors / coupling devices (such as one of the coupling devices described above with reference to Figures 9A-16) to a native heart and / or valve of an animal. , human, corpse, corpse heart, anthropomorphic ghost and / or simulation / simulator. Such devices include transcatheter devices that can be used to guide the delivery of a docking device through the vasculature. An exemplary delivery system 2220 configured to deliver a docking device 2232 to a target implantation site is shown in Figure 24B. In some embodiments, the coupling device 2232 may be one of the coupling devices described above with reference to Figures 9A-16. The delivery system may include a handle assembly 2200 and a shaft 122 exterior (e.g., a delivery catheter) 2260 that extends distally from the handle assembly 2200. The handle assembly 2200 may include a handle 2222 that includes one or more knobs, buttons, wheels, or the like. For example, in some embodiments, as shown in Figure 24B, the handle 2222 may include buttons 2224 and 2226 that may be configured to control the deflection of the delivery system (e.g., the outer shaft 2260). More details on delivery systems, such as delivery system 2220, that are configured to deliver a docking device to a target implantation site, can be found in US Patent Publications Nos. US2018 / 0318079, US2018 / 0263764 and US2018 / 0177594, which are all incorporated herein by reference in their entirety. During delivery of some docking devices to the target implantation site, the docking device is at risk of snagging, jamming and / or being obstructed by native parts of the anatomy, such as the heart wall, trabeculae, leaflets. natives, chordae tendineae, etc. due to a number of factors, such as friction forces relative to the native anatomy, the fact that a distal end or tip becomes trapped in the trabeculae and / or chordae, size differences between the internal diameter of the functional coils of a coupling device and the outer diameter of native leaflets, etc. 123 Some coupling devices have a woven or braided texture and / or covering on the surface of the coupling device to increase friction. This friction can create difficulties in advancing a docking device around that native anatomy. Additionally, the native leaflets can be up to about 55 mm in diameter, while the functional turns of the docking device are generally designed to be considerably smaller (e.g., as small as about 22 mm). When the functional turns of a coupling device are smaller, the native leaflets may push outward on a coupling device, increasing friction forces between the native leaflets and a coupling device. Once the docking device encounters an obstacle such as these, the physician, surgeon, or other medical professional may need to retract the docking device into the delivery system (e.g., a transcatheter device) and attempt to deploy the device again. coupling. This trial and error methodology can damage native tissue because existing textures or braids on the docking device rub and / or trap portions of tissue and drag it into a transcatheter delivery system, which can damage or clog the transcatheter. . supply system. Furthermore, this can 124 extend the amount of time for the implementation procedure. To overcome these challenges, it is desirable to provide a coupling device that has a lubricated outer surface (e.g., on the functional turns and / or other parts), but also has higher friction coils / functional turns once correctly positioned and during the subsequent deployment of a prosthetic valve inside. In some embodiments, this is accomplished with a temporary lubricating sheath or sleeve that can be placed over the coupling device during delivery, and that is retractable from outside the coupling device after the coupling device is in position / location. desired. In some embodiments, a lubricating or low-friction sleeve / sleeve may be incorporated into a transvascular and transcatheter delivery system, such as delivery system 2220 of Figure 24B. Embodiments of delivery systems that include a lubricating sleeve, such as delivery system 2220, may comprise one, some, or all of the following features: a durably lubricated, kink-resistant sleeve that is capable of withstanding numerous repositioning cycles (e.g. more than 30 cycles); a cuff capable of advancing the anatomy simultaneously with the docking device, but / UI 125 move independently of the coupling device and the thrust shaft of the delivery system; a cuff that increases the ease of encircling the mitral leaflets and reduces the risk of damage to the mitral anatomy; a sleeve that can be retracted before releasing the coupling device without affecting the position of the coupling device; a sleeve that does not significantly increase the length of the delivery system and / or the cross section of the coupling device; a sleeve that does not increase the deployment or recovery forces of the coupling device; a cuff that is ergonomic and does not significantly increase the number of procedural steps or include simultaneous steps; The delivery system allows one lumen inside and one lumen outside the cuff to have continuous flushing to prevent thrombosis; and a cuff having a radial resistance to compress a paravalvular leak solution (e.g., foam or braid as discussed above) into the base before retracting the cuff. To include a retractable sleeve to cover the coupling device, certain embodiments include two main shafts for supplying a coupling device, which can be actuated independently of each other: a push shaft for pushing a coupling device into place and a sleeve shaft that drives a lubricating sleeve surrounding the coupling device 126 with a minimal increase in the outside diameter of the supply system. In many embodiments, the two shafts run coaxially within a delivery catheter. For example, in some embodiments, the delivery system 2220 may include a thrust shaft 2238 and a sleeve shaft (not visible in Figure 24B) that are located coaxially within the outer shaft 2260 and each have portions that extend toward the handle assembly 2200. The thrust shaft 2238 may be configured to deploy the coupling device 2232 from within a 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 it is within the delivery system 2220 and while it is implanted at the target implantation site. Additionally, the delivery system 2220 may be configured to adjust an axial position of the sleeve shaft to remove a portion of the sleeve (e.g., the distal section) from the sleeve shaft of the coupling device 2232, after implantation at the site of target implementation, as explained below. As shown in Figure 24B, during delivery, the coupling device 2232 can be attached to the delivery system by a release suture (or other retrieval line comprising a rope, thread or other material that can be configured to tie 127 around the coupling device and cut to remove it) 2236 that extends through the thrust shaft 2238. As explained below with reference to Figure 24A and 27A-30C, the release suture 2236 can extend through the system of the release system 2220, through an internal lumen of the push shaft 2238, to a suture closure assembly 2206 of the release system 2220. Other details about the push shaft and the sleeve shaft are discussed below with reference to the Figures 24A, Figures 17A-23B and Figures 33-34. The handle assembly 2200 may further include a hub assembly 2230 with the suture closure assembly (e.g., suture closure) 2206 and a sleeve handle 2234 attached thereto. The hub assembly may be configured to control the thrust shaft and sleeve shaft of the delivery system 2220 while the sleeve handle 2234 may control a position of the sleeve shaft relative to the thrust shaft. In this manner, the operation of the various components of the handle assembly 2200 can drive and control the operation of the components disposed within the outer shaft 2260. In some embodiments, the hub assembly 2230 can be coupled to the handle 2222 via a connector 2240. . The handle assembly 2200 may further include one or more rinse ports for supplying rinse fluid to one or more lumens disposed within the delivery system. 128 2220 (e.g., annular lumens disposed between coaxial components of the delivery system 2220) in order to reduce potential thrombus formation. An embodiment in which the delivery system 2220 includes three rinse ports (e.g., rinse ports 2210, 2216 and 2218) is shown in Figure 24B. More details about these rinse ports and the components of the handle assembly 2200 are discussed below with reference to Figure 24A. sleeve shaft An example sleeve shaft 1500 according to various embodiments, which may be implemented within a coupling device delivery system, such as the delivery system 2220 of Figure 24B, is illustrated in Figures 17A-20D. Other variations of a sleeve shaft with only some of the features illustrated in these figures and / or with additional features not illustrated are also possible. In some embodiments, as illustrated in Figure 17A, the sleeve shaft 1500 comprises three sections: a distal or sleeve section 1502, which comprises the lubricating sleeve to cover the coupling device during deployment, a proximal section 1504 used to manipulate or actuate the position of the sleeve, and a middle section 1506 to connect the distal 1502 and proximal 1504 sections. A portion of the proximal section 1504 may be provided in the handle assembly (as explained further 129 below with reference to figures 24A and 35-37). Additionally, sections 1502, 1504 and 1506 of sleeve shaft 1500 may be formed from a plurality of components and / or materials, including a flexible polymer jacket 1516 (Figure 17D), a more rigid tube 1530 (Figure 17E), a inner lining 1540 (Figures 17B, 17C, 19 and 20C) and a metallic braid 1542 (which may be part of or embedded within parts of the polymer jacket 1516). For example, as explained below, the polymer jacket 1516 may be part of the distal section 1502 and the middle section 1506, the inner jacket 1540 may extend along and form an interior surface of the distal section 1502 and the middle section 1506, and the tube 1530 may form the proximal section 1504, with a portion extending toward a proximal portion of the middle section 1506. In this way, each of the distal section 1502, the proximal section 1504 and the section media 1506 of sleeve shaft 1500 may include different layers and material compositions, as explained below. As the distal section 1502 is configured to cover the coupling device, the distal section of various embodiments may be flexible, have a lower durometer (e.g., hardness), and have a hydrophilic coating. The hydrophilic coating of some modalities acts as a lubricated surface to improve the ease of surrounding native anatomy, reducing the risk of damage to the anatomy 130 native and reduce procedure time. The lubricating sleeve can cover areas of increased friction of the docking device during implantation. Additionally, the distal section 1502 may act as a cover for a braided or foam paravalvular leak solution that may exist in the coupling device, as discussed above. Since the distal section 1502 acts as a sleeve or cover for a coupling device, it can form a tubular structure in many embodiments (for example, as shown in Figure 17D, as described below). This tubular structure comprises an inner diameter sufficient to surround a coupling device and an outer diameter that is not much larger than the diameter of the coupling 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), while the outer diameter is approximately 3.4 mm (e.g., +0.5 mm). In some embodiments, the inner diameter is 2.4 mm ± 0.1 mm and the outer diameter is 3.4 mm i 0.2 mm. Furthermore, in some embodiments, the length of the distal section 1502 is sufficient to cover the entire length of the coupling device from the distal end to the proximal end thereof. In some embodiments, the distal section 1502 will be longer than the coupling device to allow some 131 of space to cover the connection regions of the coupling device or to provide additional space for greater flexibility or any other reasonable purpose. For example, in some embodiments, during delivery, a distal tip (or end) 1512 of the distal section 1502 may extend beyond a distal end of the coupling device (labeled 1514 in Figure 17B; however, in embodiments Alternatively, the location 1514 of the distal end of the coupling device may be further from the distal tip 1512), thereby providing the distal section 1502 of the sleeve shaft 1500 with a more atraumatic tip that can be bent, pinched, deformed or the like, while It is navigated through the native architecture of the docking device implantation site. This is explained in more detail below with reference to Figure 33. In some embodiments, the distal section 1502 will be approximately 400 mm (e.g., +10 mm) in length. In some embodiments, the length of the distal section 1502 may be in a range of 385 mm to 415 mm. As illustrated in Figure 18, in some embodiments, the distal section 1502 comprises several different components. In some embodiments, the distal section 1502 is constructed of a flexible polymer 1602 on a support braid 1604. The flexible polymer 1602 (which may be part of the polymer cover 1516) can be 132 select from a variety of elastomeric materials, while the braid needs to be supportive and flexible, including high-density braids (measured by peaks per inch; for example, 80ppi, 90ppi or similar). In some embodiments, braid 1604 can be constructed of metals, such as nitinol or stainless steel. In some embodiments, braid 1604 may be a stainless steel braid having a density of about 90 ppi. In certain embodiments, the flexible polymer may be a polyether amide block copolymer or a blend of two or more polyether amide block copolymers. The flexible polymer may have a Shore D hardness measured in accordance with 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 modulus of Bending measured in accordance with ISO 178:2010 between about 10 MPa and about 80 MPa, between about 10 MPa and about 25 MPa, between about 10 MPa and about 20 MPa, between about 10 MPa and about 15 MPa, between about 10 MPa and about 12 MPa, about 10 MPa, about 11 MPa, about 12 MPa, about 13 MPa, about 14 MPa or about 15 MPa. In certain embodiments, the flexible polymer may be one or a mixture 133 of two or more of grades PEBAX® 2533, 3533, 4033, 4533 and 5513 (Arkema SA, France) and VESTAMID® grade E40 (Evonik Industries AG, Germany). In some embodiments, the flexible polymer may be PEBAX® 2533. Additional embodiments of the distal section 1502 may include an inner layer (e.g., liner or inner liner) 1606 to provide an inner layer (which may be part of the inner liner or liner 1540) against the coupling device, which may be made of various polymeric materials, such as PTFE. Finally, in some embodiments, if the flexible polymer 1602 is not sufficiently lubricating, a hydrophilic coating 1608, such as a hydrogel, is applied to the outer side of the sleeve. The hydrophilic coating can serve several purposes, such as allowing a sleeved docking device to more easily navigate around the native valve anatomy without significant friction. Additionally, hydrophilic compounds increase echogenicity, allowing visualization of the sleeve by ultrasound. Additionally, distal section 1502 of some embodiments may include a radiopaque material to increase the ability to visualize the cuff during deployment of a coupling device, as described below with reference to Figure 19. While Figure 18 illustrates a construction 134 exemplary of the distal section 1502, other embodiments may use a cut (such as a laser cut), higher durometer material. In such higher hardness laser cut material embodiments, the cuts may allow the distal section 1502 to be more flexible and bend, while the higher hardness material may provide integrity to the distal section. Additionally, the distal section 1502 of the sleeve shaft 1500 of various embodiments includes a distal tip 1520, as illustrated in Figure 17B and shown in more detail in Figure 19. The distal tip 1520 may incorporate a thinner material and / or softer to help deflect the cuff if the distal tip contacts an obstruction. In some embodiments, the distal tip 1520 is also tapered so that it has a smaller diameter at its distal end 1512. As shown in Figure 19, in some embodiments, the inner liner 1540 may not extend to the distal end 1512, thereby allowing the distal end portion of the distal tip 1520 to be composed solely of the flexible polymer (e.g., the flexible polymeric material of the polymer jacket 1516). Additionally, various embodiments incorporate a radiopaque material in the distal tip 1520 to increase the visibility of the distal tip 1520 of the sleeve shaft 1500 during deployment from the delivery system (e.g., at the implantation site). 135 objective). In some embodiments, as shown in Figure 19, the radiopaque material may be in the form of one or more marker bands 1552, embedded within the polymer cover 1516 and separated from the distal end 1512. In some embodiments, a braid of 19. In some embodiments, the radiopaque material of the marker band 1552 may terminate a distance short of a distal end of the marker band 1552, such as at location 1554 shown in Figure 19. is a platinum-iridium marker, while other modalities will use a flexible polymer section loaded with bismuth or BaSO4, 60% BaSO4. The central section 1506 of the multi-modal sleeve shaft 1500 serves to provide resistance to the column to push the distal section with the base and retract the distal section 1502 after the docking device surrounds the native valve anatomy and navigates the anatomy. of a patient from the insertion point of the delivery system to the heart. Therefore, the center section 1506 of various embodiments may be flexible and have a braided polymer shaft. Furthermore, in some embodiments, the central section 1506 may comprise a flexible polymer of variable durometer along its length, as explained below with reference to Figure 17D. The center section 1506 of many embodiments can be constructed of a 136 flexible polymer on a support braid. In certain embodiments, the flexible polymer may be a polyether amide block copolymer or a blend of two or more polyether amide block copolymers. The flexible polymer may have a Shore D hardness measured in accordance with 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 in accordance with 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, approximately 175 MPa, approximately 180 MPa or approximately 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 can be of the same density (e.g. 80ppi, 90ppi 137 or similar) or a braid of lower density (e.g., 60ppi) than the distal section 1502. Additionally, in some embodiments, the middle section 1506 is a tubular structure adapted and / or configured so that the sleeve shaft can operate on a thrust shaft. As a tubular structure, the inner diameter can be about 2.25 mm (e.g., +0.3 mm), while the outer diameter is about 3.0 mm (e.g., +0.5 mm). In some embodiments, the inner diameter is 2.21 mm and the outer diameter is 3.07 mm. In various embodiments, the length of the central section will be sufficient to navigate through a patient's anatomy. In many embodiments, the length of the center section will be approximately 940 mm (e.g., +50 mm). In some embodiments, the distal section 1502 and the middle section 1506 are formed as a single continuous unit with varying properties (e.g., dimensions, polymers, braids, etc.) along the length of the singular unit. For example, Figure 17D shows an exemplary embodiment of a flexible polymer jacket (or cover) 1516 and its relative location on the previously described sections of the sleeve shaft 1500. The polymer jacket 1516 can be included and / or at least formed partially the distal section 1502 and the central section 1506 of the sleeve shaft 1500. The dashed lines in Figure 17D illustrate the proximal section 1504 of the sleeve shaft 1500, which does not 138 includes the flexible polymer jacket. In some embodiments, as explained above, the polymer jacket 1516 may comprise different grades or hardnesses of the same flexible polymer (e.g., PEBAX®), along its length. Stated another way, the polymer jacket 1516 may have a variable (e.g., increasing) hardness (may also be referred to as a durometer) along its length, from its distal end 1518 to its proximal end 1522. As an example, the distal section 1502 may comprise a flexible polymer (e.g., PEBAX®) with a first hardness (e.g., Shore D hardness). Possible Shore D grades and hardness for the 1502 distal section are discussed above. The portion of the polymer jacket 1516 that forms the middle section 1506 may comprise a first portion 1524 that comprises the same flexible polymer with a second hardness, which is greater (e.g., less flexible) than the first hardness of the distal section 1502 , and a second portion 1526 comprising the same flexible polymer with a third hardness, which is greater (e.g., less flexible) than the second hardness. Possible grades and Shore D hardness for the 1506 midsection are discussed above. In some embodiments, the first hardness may be about 20 to about 24, the second hardness may be about 50 to about 60, and the third hardness may be WUUa / 2U21 / Ul 4200 be approximately 55 139 approximately 65. In this way, the polymer jacket 1516 can increase in hardness and decrease in flexibility towards its proximal end 1522. In alternative embodiments, the polymer jacket 1516 can comprise more sections than those shown in Figure 17D with variable hardness . For example, in some embodiments, the portion of the polymer jacket 1516 that forms the middle section 1506 may comprise more than two sections with different hardness (e.g., three sections, each with a different hardness). In some embodiments, the inner liner 1540 may be disposed along an inner surface of the polymer jacket 1516, at the distal section 1502 and the middle section 1506. As explained above, in some embodiments the inner liner 1540 may comprise a thin layer of polymer, such as PTFE. The polymeric materials of the inner layer 1540 and the polymeric jacket 1516 can be configured to bond together. The proximal section 1504 of the sleeve shaft is designed to be more rigid and provide resistance to the column to activate the position of the lubricating sleeve by pushing the middle section 1506 and the distal section 1502 with the coupling device (e.g., the coupling device 70, as shown in Figures 9A to 11C) and retract the distal section 1502 after the docking device surrounds the native anatomy. As the axis of 140 sleeve 1500 of various embodiments operates surrounding the thrust shaft (for example, the thrust shaft 1900 of Figures 21A21G, as described below), the structure can be molded and configured to be generally tubular in structure and more rigid. For example, the proximal section 1504 may be formed by a relatively rigid tube 1530, as shown in Figure 17E. In some embodiments, tube 1530 may be constructed of a surgical grade metal, such as stainless steel. In some embodiments, tube 1530 may be a hypo tube. The tube 1530 may include a first section 1532 (which may form the entire proximal section 1504) and a second section 1534 that extends toward the middle section 1506 (see Figures 17E and 20B). As explained below, the first section 1532 includes a cut portion 1508 that has a cross section (in a plane normal to a central longitudinal axis 1501 of the sleeve shaft 1500) that is not a complete circle (for example, it is open and does not form a closed tube). A remainder of the tube 1530 may be tubular (e.g., a closed tube having a relatively circular cross section). As also explained below, the second section 1534 may be configured to facilitate the splicing between the inner liner 1540, disposed on an interior surface of the second section 1534, and the polymer jacket 1516, disposed on an exterior surface of the 141 second section 1534. As a tubular structure, the tube 1530 of various embodiments may have an inner diameter of approximately 2.4 mm (e.g., +0.3 mm), while the outer diameter may be approximately 3.0 mm (e.g., +0.5 mm). In some embodiments, the inner and outer diameters of tube 1530 may vary along the length of tube 1530. For example, in some embodiments, the proximal end 1536 of tube 1530 may 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 may have an inner diameter of 2.67 mm (+0.3 mm) and an outer diameter of 2.87 mm (+0.3 mm). As introduced above, the first section 1532 of the tube 1530 may include the cut portion 1508, close to the proximal end 1536. As shown in Figures 24A, 35 and 36 (described in more detail below), the cut portion 1508 of the sleeve shaft 1500 extends toward the hub assembly 2230 of the handle assembly 2200 and a portion (e.g., proximal extension 1910) of the thrust shaft 1900 extends along an interior surface of the cut portion 1508. The Cut (e.g., open) profile of the cut portion 1508 may allow the proximal extension 1910 of the thrust shaft 1900 to extend out of a void space 1544 formed in the cut portion. 142 1508 (Figures 20A and 20B) and branch, at an angle with respect to the cut portion 1508, at branch 2204 of the hub assembly (for example, a suture closure 2206 may be connected at one end of branch 2204, as shown in figure 24A). In this way, the push shaft 1900 and the sleeve shaft 1500 can be operated in parallel with each other and a total length of the supply system where the sleeve shaft 1500 and the thrust shaft 1900 are incorporated can be kept similar or alone. Minimally longer than previous supply systems that do not incorporate sleeves. In some embodiments, the cut portion 1508 may have a generally U-shaped cross section with a portion of the entire tubular structure removed. For example, the cut portion 1508 may form an open channel or passage. In various embodiments, the cut portion 1508 can be cut using a laser, although any other means can be used to remove part of the tubular structure. Exemplary embodiments of one shape of the cut portion 1508 can be seen in Figures 20A and 20B. However, in alternative embodiments, a different portion of the circumference of the tube 1530 may be removed / cut to form the cut portion 1508 than that shown in Figures 20A and 20B. An end surface 1545 (Figures 20A and 20B) is formed (e.g., exposed) on the complete tubular portion / UI 143 of the first section 1532, at an interface between the cut portion 1508 and the remainder of the first section 1532. This end surface 1545 may be arranged perpendicular to the central longitudinal axis 1501 and may be configured to come into shared face contact with a member of stop (e.g., plug 1906) of the thrust shaft (e.g., as shown in Figure 22B, as explained below). As shown in Figure 17E, the second section 1534 of the tube 1530 may include a plurality of openings 1546 that are configured to allow attachment of a proximal end of the second portion 1526 of the polymer jacket 1516, disposed on the outer surface of the second section 1534, for the inner liner 1540, disposed on the inner surface of the second section 1534. For example, as shown in Figure 20C, the inner liner 1540 may 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 Figure 20C, the inner liner 1540 and the second section 1534 of the tube 1530 are not linked together. As shown in Figure 20D, the polymer jacket 1516 can flow back over the outer surface of the second section 1534 and join, through the openings 1546, to the inner liner 1540. Thus, in Figure 20D, the second section 1534 tube 1530 144 is sandwiched between the polymer jacket 1516 and the inner liner 1540. 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 bond to each other. Therefore, the size and shape of each opening 154 6 and the relative arrangement of the openings 1546 in the second section 1534 can be selected to allow the polymer outer jacket 1516 to be securely attached to the inner liner 1540, with the second section 1534 of tube 1530 arranged between them. In this way, the tube 1530 can be secured to the polymer jacket 1516 and the inner liner 1540. In some embodiments, each of the plurality of openings 1546 may extend through a full thickness of the tube 1530. In some embodiments, the openings 1546 may be formed as through holes that are drilled or cut through the entirety of the second section. 1534 of tube 1530 (e.g., through openings). Thus, in some embodiments, at each axial location of a visible opening 1546 in Figure 17E, another opening 1546 may be located 180 degrees around a circumference of the tube 1530 from the visible opening 1546. For example, as shown In Figure 17E, the second section 1534 may include 28 openings 1546 with adjacent sets of 145 openings 1546 offset from each other by 90 degrees. In some embodiments, along the length of the second section 1532, in the axial direction, the openings may be spaced apart from each other by a first distance (center to center) 1548 and each set of openings 1546 in the same axial position. may be separated 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 a range of 2.5 mm to 3.5 mm and the second distance 1550 is in a range of 1.0 mm to 2.0 mm. In some embodiments, the second distance 1550 is half of the first distance 1548. In alternative embodiments, a different number of openings 1546 and / or relative spacing between and arrangement of openings 1546 than that shown in Figure 17E and described above is possible, while still providing an adequate bond between the inner liner 1540 and the polymer jacket 1516. In some embodiments, the apertures 1546 may be circular with a diameter ranging from 0.5 to 1.5 mm, 0.8 mm to 1.2 mm, or 0.95 to 1.05 mm. In some embodiments, the diameter of the openings 1546 may be approximately 1.0 mm. In some embodiments, the openings 1546 may have another shape, such as oblong, square, rectangular, star-shaped, triangular, or the like. The diameter or width of each 146 opening 1546 may be selected so that a flexible polymer jacket 1516 can reflow over the outer surface of the tube 1530, flow into the openings 1546 and securely adhere to the inner liner 1540 disposed on the inner surface of the tube 1530, such as as shown in the detailed view 1510 of Figure 17C, at an interface between the middle section 1506 and the proximal section 1504. In some embodiments, as shown in Figure 20A, a gasket 1804 may be located within the tubular portion of the distal portion 1504 of the sleeve shaft 1500, to form a seal between the sleeve shaft 1500 and a thrust shaft. (for example, the thrust shaft 1900 shown in Figures 21A-21G, as explained below) that extends through the sleeve shaft 1500. A seal formed by the gasket 1804, according to some embodiments, is to prevent fluids from being discharged through the delivery system to backflow or find a path of least resistance through another lumen than intended, as explained below. thrust shaft An example of a thrust shaft 1900 that can be used in a delivery system for a coupling device, such as the delivery system 2220 of Figure 24B, according to various embodiments, is illustrated in Figures 21A-21G and 23A -23B. Figure 21A illustrates the four 147 main components of the thrust shaft 1900, while Figure 21B illustrates a more detailed embodiment of the thrust shaft 1900. A side view of an exemplary distal end of the thrust shaft 1900 and a view of the proximal end are shown in Figure 21C. of the thrust shaft 1900 is shown in Figure 21D. Figures 21E-21G show some of the individual components of the thrust shaft 1900, including a main tube (which in some embodiments, may be a hypo tube) 1902 (Figure 21E), a housing 1904 (Figure 21F) and a plug 1906 (figure 21G). Figures 23A-23B show views of a portion of the thrust shaft 1900 where the housing 1904, the main tube 1902, and a proximal extension 1910 of the thrust shaft 1900 interact with each other. These figures of the thrust shaft 1900 show a central longitudinal axis 1901 of the thrust shaft 1900, which may be coaxial with the central longitudinal axis 1501 of the sleeve shaft 1500 and the outer axis 2260 of the supply system, as explained below. with reference to figures 22A-22C. As shown in Figures 21A-21G, the example thrust shaft 1900 may comprise four sections or components: the main tube (e.g., shaft) 1902 for advancing and retracting a coupling device (such as one of the coupling devices described herein) and accommodate the release suture that secures the coupling device to the thrust shaft, housing 1904 148 which surrounds the thrust shaft 1900 and allows the shaft to be locked and provides a hemostatic seal on the thrust shaft without interfering with the movement of the sleeve shaft, the plug 1906 which connects the main tube 1902 to the frame 1904 and acts as a stop for the sleeve shaft, and the proximal extension 1910 (as best shown in Figures 23A-23B) that allows the thrust shaft to be directed from the inside of the sleeve shaft to the outside of the sleeve shaft allows the two axes are driven in parallel and reduce the overall length of the supply system. The main tube 1902 may extend from a distal end of an outer shaft (e.g., outer shaft 2260 shown in Figure 24B) of the delivery system into a handle assembly (e.g., handle assembly 2200 of Figures 24A and 24B) of the supply system. For example, as shown in Figures 35 and 36, as described below, a proximal end portion 1912 of the thrust shaft 1900, which includes the interface between the main tube 1902, the housing 1904, the plug 1906 and The proximal extension 1910 (as shown in Figures 21A, 21B, and 21D), may be disposed within or near the hub assembly (e.g., hub assembly 2230) of the handle assembly. Therefore, the main tube 1902 may be an elongated tube that extends throughout the majority of the supply system. 149 In some embodiments, the main tube 1902 may be a hypo tube. Hypo tubes are components that can be used to deploy docking devices and have been previously described in US Patent Pub. 2018 / 0318079 entitled Deployment Systems, tools, and methods for delivery an anchoring device for a prosthetic valve, the contents of which are incorporated herein by reference in their entirety. In some embodiments, the main tube 1902 may comprise a biocompatible metal, such as stainless steel. In various embodiments, the main tube 1902 (shown by itself, in greater detail in Figure 21E) is a relatively rigid tube that provides resistance to the column to activate the deployment of a coupling device. The main tube 1902 may have a distal end 1914 at the point of interface with a coupling device and a proximal end 1916, where the proximal extension 1910 is attached (as explained below). In some embodiments, as shown in Figure 21E, the main tube 1902 may have a distal section 1918 that includes a plurality of cuts 1920 that provide the main tube 1902 with greater flexibility at its distal end. Therefore, 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 may be laser cuts formed by laser cutting into a surface (e.g. 150 example, the outer surface) of the main tube 1902. In alternative embodiments, the cuts 1920 may be another type of cut formed by another cutting process (for example, by engraving, scoring, cutting, etc., on the outer surface of the main tube 1902). 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 complete cuts that penetrate through the entire main tube 1902 (e.g., from one side to the other, in a direction perpendicular to the central longitudinal axis 1901). In some embodiments, the width of each cut 1920 may be approximately 0.05 mm. In some embodiments, the width of each cut 1920 may be in a range of 0.03 mm to 0.08 mm. In some embodiments, a spacing between adjacent slices 1920 may vary along the distal section 1918. For example, as shown in Figure 21E, adjacent slices 1920 may be arranged as close as possible to each other 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. Therefore, in these embodiments, the 151 separation or distance between adjacent cuts 1920 can be defined as the pitch of the cuts. In an exemplary embodiment, as shown in Figure 21E, a first portion 1922 of the distal section 1918 may have a pitch in a range of 0.4 mm to 0.64 mm, a second portion 1924 of the distal section 1918 may have a pitch In a range of 0.64 to 1.2 mm, a third portion 1926 of the distal section 1918 may have a pitch of 1.2 mm, and a fourth portion 1928 of the distal section 1918 may have a pitch in a range of 1.2 mm to 3.0 mm. In some embodiments, the pitch of the first portion 1922 may increase from 0.4 mm (at its distal end 1914) to 0.64 mm along its length, the pitch of the second portion 1924 may increase from 0.64 mm to 1.2 mm along its length. along its length, the pitch of the third portion 1926 may be approximately 1.2 mm along its length, and the pitch of the fourth portion 1928 may increase from 1.2 mm to 3.0 mm along its length. It should be noted that the above pitch values for the distal section 1918 are exemplary and other pitches may be possible, where the pitch values may be selected to provide the main tube 1902 with greater flexibility at its distal end 1914 and a decreasing amount of flexibility. along the distal section 1918. In this way, the distal section 1918 can be configured to flex and / or bend along with the outer shaft 2260 of the delivery system, while being navigated through 152 of an internal lumen of a patient, for the target implantation site. The main tube 1902, in some embodiments, may include one or more portions or sections that include a plurality of openings 1934 that are configured to allow the attachment of a flexible polymer outer layer (e.g., cover or jacket), arranged along along a portion of an outer surface of the main tube 1902, to an inner liner, the inner liner being disposed along an inner surface of the main tube 1902 (e.g., similar to the openings 1546 of the sleeve shaft 1500). At the same time, the openings 1934 can be configured to provide rigidity to the thrust shaft 1900. The embodiment of the main tube 1902 shown in Figure 21E includes a first section 1930 and a second section 1932, spaced apart, each of which includes one or more openings 1934 that extend through a thickness of the main tube 1902 ( for example, through holes extending from and through an outer surface to an inner surface of the main tube 1902). The openings 1934 may be spaced about a circumference of the main tube 1902. In some embodiments, as shown in Figure 21E, each opening 1934 may extend across the entirety of the main tube 1902, thereby creating two openings 1934 arranged 180 degrees from each other 153 around the circumference of the main tube 1902. Additionally, in some embodiments, adjacent sets of openings 1934 may be offset relative to each other by 90 degrees (for example, as shown in Figure 21E, the first section 1930 may include 20 openings). The size and / or shape of each opening 1934 and a number and spacing between the openings 1934 of each of the first section 1930 and the second section 1932 can be selected to allow the outer flexible polymer layer to bond (e.g., join ) to the inner liner, with the main tube 1902 disposed therebetween and still, providing rigidity to the thrust shaft 1900. For example, in some embodiments, the openings 1934 may be circular with a diameter in a range of 0.4 to 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 another shape, such as oblong, square, rectangular, star-shaped, triangular, or the like. In some embodiments, along the length of the first section 1930 and the second section 1932, in the axial direction, the openings may be spaced apart by a first distance (center to center) 1952 and each set of the openings 1934 in the same axial position can be separated from an adjacent set of openings 1934 by a second distance 1954. In some embodiments, the first 154 distance 1952 is approximately 2 mm and the second distance 1550 is approximately 1.0 mm. In some embodiments, the first distance 1952 is in a range of 1.5 mm to 2.5 mm and the second distance 1954 is in a range of 0.5 mm to 1.5 mm. In some embodiments, the second distance 1954 is half of the first distance 1952. In alternative embodiments, a different number of openings 1934 and / or relative spacing between and arrangement of the openings 1934 than that shown in Figure 17E and described above possible, while still providing an adequate bond between the inner liner and the outer flexible polymer, while providing rigidity to the thrust shaft 1900. 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 those 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 less than 20 openings 1934 and the second section 1932 may include more or less than 8 openings 1934. As shown in Figure 21E, the main tube 1902 may include a third section 1936 arranged and 155 extends between the first section 1930 and the second section 1932 which does not include any opening 1934. Figure 21B illustrates an exemplary embodiment of the materials and components of the thrust shaft 1900. As shown in Figure 21B, the thrust shaft 1900 may include an inner liner 1938 that covers an interior surface of the main tube 1902 and forms a surface interior of the proximal extension 1910. In some embodiments, the inner liner 1938 may extend along the entire length of the thrust shaft 1900. The inner liner may be the same or similar to the inner layer 1606 (shown in Figure 18 ). In some embodiments, the inner liner may comprise PTFE. Additionally, in some embodiments, the thickness of the inner liner 1938 may be in a range of 0.012 mm to 0.064 mm. Additionally, in some embodiments, a portion of the thrust shaft 1900 may include a polymer layer (also referred to as an outer shell or jacket) 1940. The polymer layer may be a flexible polymer, as explained below. In some embodiments, the outer polymer layer 1940 is disposed over and along a fourth section 1942 (the fourth section 1942 including the distal section 1918 and the first section 1930) of the main tube 1902, while the third section 1936 of the main tube 1902 does not include the outer polymer layer 1940 (Figures 21B and 21E). In some embodiments, the outer polymer layer 1940 156 is also included in the second section 1932 of the main tube 1902 and forms an outer layer of the proximal extension 1910. For example, the proximal extension 1910 may comprise the inner liner 1938 and the outer polymer layer 1940. The outer polymer layer 1940 may be reflowed over the cuts 1920 and openings 1934. In certain embodiments, the outer polymer layer 1940 may comprise a polyether-amide block copolymer or a blend of two or more polyether block copolymers. -amide. The polymer of the outer polymeric layer 1940 may have a Shore D hardness measured in accordance with 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 In embodiments, the outer polymer layer 1940 may have a flexural modulus measured in accordance with 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 layer 157 polymer exterior 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 may be PEBAX® 7233. In other embodiments, the outer polymer layer 1940 may be VESTAMID® EX9200. In some embodiments, the main tube 1902 may have a uniform inner diameter, from its distal end 1914 to its proximal end 1916, in a range of about 1.0 mm to about 1.34 mm, while the outer diameter can vary from about 1.8 to 2.0 mm (e.g., ±0.2 mm) in the proximal and distal sections. An exemplary embodiment of the distal tip 1942 of the thrust shaft 1900 is shown in Figure 21C. In some embodiments, the distal tip 1942 includes a more flexible polymeric tip or a distal end portion 1944 comprising a flexible polymer. In some embodiments, the polymeric distal end portion 1944 may comprise the same flexible material and / or be continuous with the outer polymer layer 1940. Therefore, the polymeric distal end portion 1944 of the tip 1942 may be reflowed over the distal end. 1942 from the main tube 1902 and join the inner liner 1938. As shown in Figures 21A, 21B and 21D, a 158 inner diameter 1948 of the housing 1904 is larger than an outer diameter 1950 of the main tube 1902, thus forming an annular cavity 1946 between (in the radial direction) the main tube 1903 and the housing 1904. In this way, the proximal part 1504 The sleeve shaft 1500 can slide within the annular cavity (e.g., space) 1946, as described below with reference to Figures 22A-22C. Additionally, flushing fluid provided to a lumen on an exterior of the proximal extension 1910, in the hub assembly, may flow through the annular cavity 1946 and exit the distal end of the shell, as shown by arrows 3202. to enter a lumen (supply shaft lumen 3216 shown in Figure 38) between the sleeve shaft 1500 and the outer shaft 2260 of the supply system, as described below with reference to Figures 35-38. A side view of an exemplary embodiment of the housing 1904 of the thrust shaft 1900 is shown in Figure 21F. The housing 1904 may include a distal section 1960, a middle section 1962, and a proximal section 1964. The distal section 1960 may be formed by the 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 different grade of PEBAX® as the 159 outer polymer layer 1940 of the main shaft 1902 and / or have a hardness equal to or different from that of the outer polymer layer 1940. As shown in Figure 21F, a distal end 1968 of the housing 1904 may have a rounded edge . Together, the rounded edge of the distal end 1968 and the more flexible nature of the distal section 1960 (because it is composed of the inner liner 1938 and the outer polymer layer 1966 and not a more rigid tube), can provide a distal tip more atraumatic to the housing 1904, thereby reducing or preventing abrasion to an interior surface of the outer shaft of the delivery system surrounding the housing 1904 (e.g., the outer shaft 2260). The central section 1962 of the housing 1904 may comprise the inner liner 1938, the outer polymer layer 1966 and a more rigid tube 1968 disposed between the inner liner 1938 and the outer polymer layer 1966 (in the radial direction). In some embodiments, tube 1968 may comprise metal, such as stainless steel. In some embodiments, the 1968 tube may be a hypo tube. The tube 1968 may comprise a plurality of openings 1970 that extend through the entire thickness of the tube 1968, similar to the openings 1934 of the main tube 1902, as described above. As described above, a size, number and arrangement of the openings 1970 can be selected to provide rigidity to the second section 1962. 160 while also allowing the outer polymer layer 1966 to flow through the openings 1970 and form a secure bond with the inner liner 1938. In some embodiments, the diameter of the openings 1970 may be in a range of 1.0 to 1.4 mm. In some embodiments, the diameter of the openings 1970 may be approximately 1.2 mm. The proximal section 1964 of the housing 1904 may comprise the tube 1968, without openings. Furthermore, as shown in Figure 21F, the proximal section 1964 does not include the outer polymer layer 1966 or the inner liner 1938. As shown in Figures 35-37, the proximal section 1964 of the housing 1904 can extend towards and / or within the hub assembly 2230. near the location where the proximal extension 1910 of the thrust shaft 1900 angles away from the cut portion 1508 of the sleeve shaft 1500. A proximal end 1905 of the proximal section 1964 Housing 1904 may be configured to receive plug 1906, as explained below. The plug 1906 may be configured to be disposed within the annular cavity 1946, at the proximal end 1905 of the housing 1904 (as shown in Figures 21A, 21B, 21D and 23B). In some embodiments, the plug 1906 may have a length 1907, extending in a direction of the central longitudinal axis 1901 (as shown in Figure 21A). In some embodiments, the length 1907 is in a 161 range from 3.0 mm to 9.0 mm, from 4.0 mm to 8.0 mm, from 5.0 mm to 7.0 mm or from 5.5 to 6.5 mm. In some embodiments, the length 1907 is approximately 6.0 mm. The plug 1906 may be configured to plug or fill a portion of the annular cavity 1946, at the proximal end 1905, leaving a remainder of the annular cavity portion open to receive the cut portion 1508 of the sleeve shaft 1500 therein. For example, as shown in the end view of Figure 21G, in some embodiments, the plug 1906 of the thrust shaft 1900 may include an annular portion 1972 and a crescent-shaped portion 1974 that extends radially outwardly. from one side of the annular portion 1972. An inner diameter 1976 of the annular portion 1972 may be selected such that the annular portion 1972 surrounds an outer surface of the main axis 1902 and an outer diameter 1978 of the crescent-shaped portion 1974. can be selected so that the crescent-shaped portion 1974 fills the annular space 1946. For example, the inner diameter 1976 can be selected to be slightly larger than the outer diameter 1950 of the main shaft 1902 and the outer diameter 1978 can be selected to be slightly larger than the outer diameter 1950 of the main shaft 1902. can be selected to be slightly smaller than the inner diameter 1948 of the housing 1904 (as shown in Figure 21A). In some embodiments, the inner diameter 1976 is approximately 1.81 mm and the outer diameter 1978 is approximately 1.81 mm. 162 approximately 3.42 mm. An arc length of the crescent-shaped portion 1974 may be in a range of 60 to 140 degrees, 80 to 120 degrees, 90 to 110 degrees, or 95 to 105 degrees. The housing 1904 and plug 1906 of various embodiments are welded to the main tube 1902 to allow the cut portion 1508 of the sleeve shaft (Figures 20A and 20B) to slide between the main tube 1902 and the housing 1904. For example, such as shown in Figure 21D, a first weld 1980 may secure the annular portion 1972 of the plug 1906 to the main shaft 1902 and a second weld 1982 may secure the crescent-shaped portion 1972 of the plug 1906 to the housing 1904. In some embodiments , each of the welds 1980 and 1982 may be spot welds that do not extend along the entire length of the contact surfaces between the plug 1906 and the main shaft 1902 and the housing 1904. The proximal extension 1910. of certain embodiments is illustrated in Figures 23A and 23B. Figures 23A and 23B illustrate the proximal extension 1910 that extends from the proximal end of the main tube 1902 and the housing 1904. As noted above, the proximal extension 1910 provides the thrust shaft 1900 flexibility so that it can be routed from the inside of the sleeve shaft (e.g., the cut portion 1508) toward the outside of the sleeve shaft, thus allowing the two shafts to be driven in parallel. WUUa / 2U21 / Ul 4200 163 parallel. In many embodiments, as discussed above, the proximal extension 1910 may be made of a flexible polymer. In certain embodiments, the flexible polymer is a polyether amide block copolymer or a blend of two or more polyether amide block copolymers, such as PEBAX® grades 2533, 3533, 4033, 4533, 5533, 6333 and 7033 and 7233 (Arkema SA, France) and VESTAMID® grades E40, E47, E55, E62, E72 and EX9200 (Evonik Industries AG, Germany). Thrust shaft and sleeve shaft assembly As introduced above, the push shaft 1900 and the sleeve shaft 1500 may be coaxial with each other, at least within an outer shaft 2260 (e.g., part of the catheter) of the delivery system (e.g., delivery system 2220 of Figure 24B). Figures 22A-22C are assembly views illustrating an arrangement of the thrust shaft 1900 and the sleeve shaft 1500 on the outer shaft 2260 of the delivery system. Furthermore, Figures 33 and 34 are perspective views showing an example of coupling device 70 deployed from the outer shaft 2260 of the delivery system, covered by a distal portion (or sleeve) 1502 of the sleeve shaft 1500 (Figure 33). , and the example coupling device 70 after the sleeve shaft 1500 has retracted back to the outer shaft 2260 (Figure 34). As shown in Figures 22A-22C, 33 and 34, the 164 sleeve shaft 1500 may be configured to cover (e.g., surround) the coupling device 70 and, together, the thrust shaft 1900 and the sleeve shaft 1500 may be configured to deploy the coupling device 70 from the outer shaft 2260 of the supply system, upon reaching the target implementation site. As described below, Figures 22A-22C, 33 and 34 illustrate different stages of the implementation process. Figures 22A and 22B illustrate how the proximal section 1504 of the sleeve shaft 1500, including the cut portion 1508, passes through the proximal end portion 1912 of the thrust shaft 1900, between the main tube 1902 and the housing 1904, within the annular cavity 1946. Specifically, Figure 22A illustrates an example of a first configuration of the thrust shaft 1900 and the sleeve shaft assembly, before deployment or during deployment of the coupling device 70, wherein the sleeve shaft 1500 is arranged on the coupling device 70 and the end surface 1545 of the tube 1530 is positioned away from the plug 1906. During deployment of the coupling device 70 from the outer shaft 2260 of the delivery system, the thrust shaft 1900 and the Sleeve 1500 can move together, in the axial direction, with the coupling device 70. For example, driving the thrust shaft 1900. to push against the / UI device 165 coupling 70 and removing it from the outer shaft 2260 can also cause the sleeve shaft 1500 to move together with the thrust shaft 1900 and the coupling device 70. In this way, the coupling device 70 can remain covered by the distal section 1502 of the sleeve shaft 1500 during pushing the coupling device 70 to its position at the target implantation site through the thrust shaft 1900, as also shown in Figure 33. In some embodiments, as shown in Figure 22A, the outer shaft 2260 may 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 may be larger than the first inner diameter 2104 in order to accommodate the wider housing 1904 therein. Furthermore, as introduced above with reference to Figure 17B and as shown in Figure 33, during delivery and implantation of the covered coupling device 70 at the target implantation site, the distal tip 1512 of the distal section 1502 of the Sleeve shaft 1500 may extend distal to (e.g., beyond) a distal end 1514 of the coupling device 70, thereby providing the distal section 1502 of the sleeve shaft 1500 with a more atraumatic tip. In some embodiments, the 166 distance between the distal tip 1512 of the sleeve shaft 1500 and the distal end 1514 of the coupling device 70, during implantation at the target implantation site and before retracting the sleeve shaft 1500 of the coupling device 70, may be in a range of about 3 mm to about 1 mm, from about 2 mm to about 1.2 mm, or from about 1.7 mm to about 1.4 mm. As shown in Figure 33, in some embodiments, the distal end 1514 of the coupling device 70 may be disposed near or simply away from a marker band 1552 of the sleeve shaft 1500. Figure 22B illustrates a second configuration of the thrust shaft 1900 and sleeve shaft 1500 assembly, after deploying the coupling device 70 from the outer shaft 2260 at the target implantation site and retracting the sleeve shaft 1500 away from the coupling device. implanted coupling 70. As shown in Figure 22B, after implanting the coupling device 70 at the target implantation site, in its desired position, the sleeve shaft 1500 can be removed from the coupling device 70 and retracted towards the shaft outer 2260. In some embodiments, as shown in Figure 22B, the sleeve shaft 1500 may be stopped from further retracting into the delivery system when the end surface 1545 contacts the plug 1906. 167 Figure 34 shows the sleeve shaft 1500 removed from the coupling device, leaving the coupling device 70 exposed. As shown in Figure 34, the distal tip 1512 of the sleeve shaft 1500 may be disposed close to (e.g., retracted beyond) the distal end of the thrust shaft 1900 which may still be connected to the end of the coupling device 70 by a suture. 2236. As explained below, after implanting the coupling device 70 at the target implantation site and removing the distal portion 1502 of the sleeve shaft 1500 so that it does not cover the coupling device, the coupling device 70 can be disconnected from the delivery system by cutting suture 2236 by a suture securing assembly of the delivery system (e.g., suture closure assembly 2206 shown in Figure 24A and / or suture closure 2700 shown in Figures 27A-29D). Turning to Figure 22C, certain embodiments include a sealing mechanism 1908 located in the main tube 1902 of the thrust shaft 1900 of some embodiments. A sealing mechanism 1908 in some embodiments forms a seal between the main tube 1902 of the thrust shaft 1900 and the sleeve shaft 1500 to prevent fluids from flowing through the system to backflow or find a path of least resistance through another. lumen (as described below with reference to Figures 35-38). Certain modalities will use 168 a gasket made of plastic, rubber, PTFE, PBAX or other suitable material that is placed in the main tube 1902 of the thrust shaft 1900. In embodiments that use a gasket, the gasket is joined in place by fusing the gasket to the tube main 1902. while some embodiments will adhere the joint using a glue or other adhesive. Additional embodiments will fabricate the main tube 1902 to include a protrusion or protrusion on the main tube 1902 that extends toward the sleeve shaft 1500 as the sealing mechanism 1908, while certain embodiments will form a projection or protrusion on the sleeve shaft 1500 that extends towards the main tube 1902 as the sealing mechanism. Certain embodiments will include various sealing mechanisms 1908 to form a seal between the main tube 1902 of the thrust shaft 1900 and the sleeve shaft 1500 of any combination of bosses and / or seals. Additional embodiments will further include a seal located toward the proximal end (e.g., seal 1804 of Figure 20A) of the sleeve shaft 1500 in addition to one or more sealing mechanisms 1908. Handle system As introduced above, the delivery system (e.g., delivery system 2220 of Figure 24B) may include a handle assembly 2200 that is configured to control operation of the delivery system, including the push shaft and the shaft. of sleeve. 169 The handle assembly can be configured in a variety of ways with one or more of a variety of components, handles, hubs, connectors, knobs, shafts, etc. An example embodiment of the complete handle assembly 2200, as described above, is shown in Figure 24B. As illustrated in Figure 24A and introduced above, the handle assembly 2200 in some embodiments comprises the hub assembly 2230, which in some embodiments may comprise 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., branch conduit) 2204 (although, in some embodiments, it may include more than one branch). In some embodiments, the suture closure assembly (e.g., suture closure) 2206 can be attached to the branch 2204 and a cuff drive handle 2208 (which may be similar to the cuff handle 2234 of Figure 24B) can be placed at a proximal end of the straight section 2202. The hub assembly 2230 can be adapted and configured to allow the proximal extension 1910 of the thrust shaft 1900 (or other similar thrust shaft) to extend to the closure assembly of suture 2206 disposed at the end of the branch 2204, while the cut portion 1508 of the sleeve shaft 1500 extends to the sleeve drive handle 2208, disposed at the end of the straight section 2202. With this configuration, a medical professional can run the 170 deploying the coupling device (for example, coupling device 2232 of Figure 24B and / or coupling device 70 of Figures 9A-12G and 22A22C) by manipulating the position of the handle assembly 2200 (for example, moving it in the direction axial) and also executing retraction of the sleeve shaft (out of and away from the implanted coupling device) by pulling back, in the axial direction, the sleeve drive handle 2208. Therefore, such a configuration of the handle can only add an additional step in retraction of the sleeve shaft, compared to delivery systems that do not include a sleeve shaft or other removable cover for the coupling device. The sleeve shaft and thrust shaft assembly can be configured to work together so that they can be moved simultaneously when deploying and positioning the coupling device on the native valve (for example, by moving the entire hub assembly 2230 forward and / or or rearward, in the axial direction), but can also be moved independently so that the thrust shaft 1900 can hold the coupling device in position while the sleeve shaft 1500 is retracted away from the coupling device (e.g., by holding the hub assembly 2230 in place with respect to the outer shaft 2260 of the supply system and / or other portions of the supply system and / or 171 coupling device while pulling the cuff drive handle 2208 proximally to remove the cuff). As introduced above and shown in Figures 22A-22C, the sleeve shaft 1500 and the thrust shaft 1900 may be coaxial throughout part, all, or most of the delivery system to facilitate this working together. The handle assembly 2200 may include one or more flush ports that permit discharge of the various lumens (e.g., annular spaces disposed between components, such as coaxial shafts) disposed between the axially extending components of the delivery system. For example, as shown in Figure 38 illustrating a distal end portion of a delivery system (e.g., delivery system 2220) that includes a thrust shaft (e.g., thrust shaft 1900) and a sleeve (e.g., sleeve shaft 1500) arranged within an outer shaft 2260 of the delivery system, several lumens configured to receive flushing fluid are formed during a delivery and implantation procedure between the coupling device 70, the thrust shaft 1900, the sleeve shaft 1500 and the outer shaft 2260. A first thrust shaft lumen 3210 may be formed within the interior of the thrust shaft (e.g., within an interior of the main tube 1902). The thrust shaft lumen 3210 may receive a flushing fluid from a first source 172, which may be fluidly coupled to a portion of the handle assembly (e.g., branch 2204, as described below). The flow of flushing fluid 3204 through the lumen 3210 of the thrust shaft may travel along a length of the main tube 1902 of the thrust shaft 1900, to the distal end 1914 of the thrust shaft 1900. Since, as As shown in Figure 38, the distal end 1914 of the thrust shaft 1900 may be spaced from a proximal end of the coupling device 70. At least a portion of the rinse fluid flow 3204 may flow to a first portion of a second lumen. 3212 of the sleeve shaft, which is disposed between an outer surface of the coupling device 70 and an inner surface of the distal section 1502 of the sleeve shaft 1500. such as flow of rinse fluid 3208. Additionally, in some embodiments, a portion The flushing fluid flow 3204 may also flow into a second portion of the lumen 3214 of the sleeve shaft, which is disposed between an outer surface of the thrust shaft 1900 and an inner surface of the sleeve shaft 1500, such as flushing fluid flow. flush 3206. In this way, the same first fluid source can provide flush fluid to each of the thrust shaft lumen 3210, the first portion of the sleeve shaft lumen 3212, and the second portion of the sleeve shaft lumen 3214. , through the thrust shaft lumen 3210. 173 As also shown in Figure 38, a third supply shaft lumen 3216 may be formed in an annular gap between an inner surface of the outer shaft 2260 and an outer surface of the sleeve shaft 1500. The supply shaft lumen 3216 may receiving a rinse fluid from one or more second fluid sources, which may be fluidly coupled to a portion of the handle assembly (e.g., branch 2204 and / or handle 2222, as described below), and which may result in a flow of flushing fluid 3202 flowing through the lumen of supply shaft 3216, to a distal end of the outer shaft 2260. Flushing the lumens described above is important to prevent thrombosis in and around the docking device and other concentric parts of the delivery system during deployment of the docking device from the delivery system and implantation of the docking device at a target implantation site. . To flush these lumens, various embodiments will have one or more flush (flush) ports disposed in and / or coupled to the handle assembly 2200 of the delivery system. Figures 24A, 24B, 28A, 35 and 36 show different embodiments of an arrangement of possible rinse ports configured to provide rinse fluid to the lumens described above with reference to the 174 Figure 38. Additionally, Figure 37 illustrates a flow of the rinse fluid through a portion of the delivery system disposed between the hub assembly 2230 (as shown in Figures 24A, 35 and 36) and the end portion distal of the delivery system (as shown in Figure 38). In a first embodiment of a rinse port arrangement, the handle assembly 2200 may include two rinse ports disposed on the branch 2204 (which may be referred to as the suture closure branch) of the hub assembly 2230, one of which provides the flow of rinse fluid 3204 to the lumen of thrust shaft 3210 and another of which provides flow of rinse fluid 3202 to the lumen of supply shaft 3216. For example, the two rinse ports on branch 2204 may include a first rinse port 2210 and a second rinse port 2216, the first rinse port 2210 arranged proximal to the second rinse port 2216 on the branch 2204. In some embodiments, the location of the second rinse port 2216 on the branch 2204 may be more closer to or further from the first rinse port 2210 than shown in Figures 24A, 35 and 36. As shown in Figures 24A, 35 and 36, the first flush port 2210 has an internal flow lumen that is fluidly connected to an internal cavity 2250 in the branch 2204. An open proximal end 2252 of the extension Proximal 175 1910 of the thrust shaft 1900 may be fluidly coupled to and / or disposed within the internal cavity 2250 (as shown in Figures 24A, 35 and 36). As explained above, the proximal extension 1910 passes through the branch 2204, into the straight section 2202 of the hub assembly 2230, and connects to the main tube 1902 of the thrust shaft (Figure 36). Thus, the thrust shaft lumen 3210 is formed by and within the main tube 1902 and the proximal extension 1910. In this way, the flow of flushing fluid 3204 from the first flush port 2210 enters the thrust shaft lumen 3210 at the proximal end 2252 of the extension 1910 and continues within and through the entirety of the main thrust shaft tube 1902, to the distal end 1914 (as shown in Figure 38). The second flush port 2216 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) surrounding an exterior of the proximal extension. 1910 within the branch 2204 and extending within the straight section 2202, in a space between an interior surface of the cut portion 1508 of the proximal section 1504 of the sleeve shaft 1500 and the proximal extension 1910. Therefore, the flow of Rinse fluid 3202 from the second rinse port 2216 can enter the cavity 2254 and flow through the cavity 2254, around the 176 proximal extension 1910, and within the annular cavity 1946 (figure 37). As explained above with reference to Figures 21A and 22A, the rinse fluid flow 3203 can flow through the annular cavity 1946 and exit the distal end of the housing 1904, as shown by the arrows 3202 in the figures 21A and 22A, to enter the supply shaft lumen 3216. In some embodiments, as shown in Figures 24B and 35, the supply shaft lumen 3216 may be provided with additional rinse fluid from a third rinse port 2218 (in addition to the fluid from the second rinse port 2216) coupled to fluidly to the annular cavity 1946, downstream of (e.g., away from) the plug 1906. Thus, in some embodiments, the supplemental rinse fluid 3218 can be combined with the flow of rinse fluid 3202 and supplied to the lumen of supply shaft 3216. In some embodiments, as shown in Figures 24B and 35, the third rinse port 2218 can be arranged in a handle portion 2222. In alternative embodiments, the third rinse port 2218 can be arranged in a more distal location on the handle than shown in Figures 24B and 35. In some embodiments, the third flush port 2218 cannot be used during an implantation procedure, but can only be used to flush the supply shaft lumen. 3216 before 177 insertion of the delivery system into a patient. In some embodiments, the delivery system may not include the third rinse port 2218. Various embodiments of the hub assembly 2230, including the first embodiment of the rinse port arrangement described above, may include a gasket 2211 located within the branch 2204, between the two rinse ports in the branch 2204, to create flow lumens. of distinct and separate fluid fed by the two rinse ports in branch 2204 (for example, the first rinse port 2210 and the second rinse port 2216 shown in Figures 24A, 35 and 36 or the second rinse port 2216 and a rinse port 2806 shown in Figure 28A). For example, gasket 2211 may be configured as a disc with a single hole (e.g., central in some embodiments) configured to firmly receive proximal extension 1910 therein. The gasket 2211 may not include any additional holes and may further be configured to provide a seal between the internal cavity 2250 and the cavity 2254. As a result, any flow of rinse fluid 3204 entering the internal cavity 2250 from the first flush port 2210 (or, alternatively, from flush port 2806, as described below) may enter the thrust shaft lumen 3210, without entering the cavity 2254 and flow into the thrust shaft lumen. supply 178 3216. Likewise, all the flow of rinse fluid 3202 that enters the cavity 2254 of the second rinse port 2216 can enter the annular cavity 1946 and the lumen of supply shaft 3216. In a second embodiment of a rinse port arrangement, the handle assembly 2200 may include two rinse ports disposed on the branch 2204 (which may be referred to as the suture closure branch) of the hub assembly 2230, one of which provides the flow of rinse fluid 3204 to the lumen of thrust shaft 3210 and another of which provides the flow of rinse fluid 3202 to the lumen of supply shaft 3216. However, in the second embodiment, the discharge port that provides the flow of discharge fluid 3204 to the lumen of thrust shaft 3210 may be disposed at a proximal end of the branch 2204, at one end of a suture closure assembly (for example, the suture closure assembly 2206 of Figures 24A and 24B or the suture closure assembly 2700 of Figures 27A-29D). For example, as shown in Figure 28A, flush fluid flow 3204 may be provided through a flush port 2806 disposed at a proximal end of a suture closure assembly 2700). In this way, the rinse fluid flow 3204 can be provided to the thrust shaft lumen 3210 through a rinse port (e.g., rinse port 2806) with a flow lumen 179 arranged parallel to the thrust axis lumen 3210 (instead of perpendicular to the thrust axis lumen 3210, as shown in Figures 24A, 24B, 35 and 36). Embodiments of the rinse port arrangement having multiple rinse ports, such as the first and second embodiments described above, may be supplied with rinse fluid independently (e.g., with two separate fluid supply sources) or along with a common fluid supply source. For example, in some embodiments, each rinse port (e.g., first rinse port 2210 and second rinse port 2216 or rinse port 2806 and second rinse port 2216) may be supplied with rinse fluid of two separate infusion pumps (one fluidly coupled to each). flush ports) or other set of fluid sources. In alternative embodiments, a single infusion device (e.g., pump) 3220 may be connected to multiple flush ports, such as through a Y-connector 3222 that connects a single fluid line to multiple flush ports, such as is shown in Figure 35. As shown in Figure 35, the first rinse port 2210 and the second rinse port 2216 receive fluid from the same source (for example, the infusion pump 3220). In some embodiments, the infusion pump 3220 can supply fluid to the rinse port 180 2806 and to the second rinse port 2216. It may be desirable that the flow of rinse fluid be balanced between the lumens, so that the flow of rinse fluid is equal in each lumen. However, in some embodiments, the flow of flushing fluid passing through the thrust shaft lumen 3210 may possess increased resistance, relative to the supply shaft lumen 3216. In one example, this increased resistance may be due to to a narrower flow lumen and / or friction between a cover (e.g., cover 100, Figures 12A-12D) and sleeve section of a sleeve shaft (e.g., sleeve 1502, Figures 17A-17E). As an example, an additional flush port may be added to supplement flow to the thrust shaft lumen 3210, in order to equalize flow between the lumens. As another example, two separate infusion devices can be used to provide the desired flow rates of flushing fluid to the thrust shaft lumen 3210 and the supply shaft lumen 3216. The resistance in the supply shaft lumen 3216 is may increase to equal the relative resistance between the supply shaft lumen 3216 and the thrust shaft lumen 3210. For example, certain embodiments may alter the fluid flow rate received by the supply shaft lumen 3216 and the drive shaft lumen. push 3210 of the single infusion device 3220 by altering an inner diameter of one or both of the lumen of the port of 181 rinse (for example, decreasing the diameter of an interior lumen of the second rinse port 2216 with respect to the first rinse port 2210), a diameter of the branch portions of the Y-connector 3222, or other component to alter relative flows to cavity 2254 (feeding supply shaft lumen 3216) and thrust shaft lumen 3210. Thus, it may be desirable to balance the resistance to fluid flow between the flow paths in and / or toward the thrust shaft lumen 3210 and the supply shaft lumen 3216, so that both lumens receive the same fluid flow. flushing fluid from a single source (e.g., a single 3220 infusion device). Various embodiments may include altering the resistance of one or more components in one of the two flow paths (e.g., push shaft lumen flow path or supply shaft lumen flow path) and / or providing one or more more devices that measure a uniform flow rate of rinse fluid to each of the thrust shaft lumen 3210 and the supply shaft lumen 3216. Therefore, the flow of rinse fluid in these two lumens can be controlled in either way known in the art to ensure that the flow rate in the lumens is equal, based on their relative resistances. Additionally, during an implantation procedure, differences in flow resistance may be experienced within each of and 182 between the thrust shaft lumen 3210 and the supply shaft lumen. Therefore, it may be desirable to supply fluid flow to these lumens individually (e.g., through separately controlled flow sources) or through the single infusion device 3220 with a mechanism to balance resistance between the lumens (and provide a target flow). Some embodiments may include a mechanism (such as a sensor, alarm or the like) to detect when a flow rate of rinse fluid falls below a preset threshold flow rate within one or more of the lumens that receive the rinse fluid (e.g. , the push shaft lumen and the supply shaft lumen). For example, infusion devices may have alarms to alert a medical professional or user of a blockage in flow, which may occur due to an occlusion in the system by a thrombus. Thrombi can cause a stroke if they dislodge during the installation of a docking device. Additionally, thrombi may increase the force experienced during removal of the distal portion of the sleeve shaft 1502 from the coupling device because they cause increased friction between the sleeve and the coupling device. As an example, the use of two infusion devices allows certain modalities to identify when a thrombus forms in one or more of the lumens, even when flow is prevented. WUUa / 2U21 / Ul 4200 183 of cross lumens using gaskets or other sealing mechanisms (for example, gasket 1804, shown in Figures 20A-20D and sealing mechanism 1908 shown in Figure 22C). Other modalities use a single infusion device connected to multiple flush ports and the use of flow sensors connected to the flow lines (and / or alarms) to notify a medical professional of changes in flow rate, which may indicate a blockage, such as a thrombus. In a third embodiment of a rinse port arrangement, the handle assembly 2200 may include a single rinse port disposed on the branch 2204 of the bucket assembly 2230, the single rinse port configured to provide both rinse fluid flow 3204 to the thrust shaft lumen 3210 as the flush fluid flow 3202 to the supply shaft lumen 3216. For example, certain configurations are capable of flushing all of the lumens described above with a single flush line, such as the first port rinse port 2210 (or alternatively, port 2806 shown in Figure 28A). In such embodiments, the single flush port may provide fluid to the two separate lumens (thrust shaft lumen 3210 and supply shaft lumen 3216), incorporating a flush plate 2300 (shown in Figure 25) in branch 2204. , normal to the flow paths through the thrust shaft lumen 3210 and the cavity 2254. For example, in some embodiments, the plate 184 of rinse 2300 can be arranged where gasket 2211 is shown in Figure 36 (for example, in place of gasket 2211 and without a second rinse hole 2216), or further below where the gasket is shown. Figure 25 illustrates rinse plate 2300 which can be used in various embodiments. As shown in Figure 25, the rinse plate 2300 may have openings or pores 2301a, 2301b and 2301c cut into it to equalize resistance between the various lumens. The openings / pores 2301a, 2301b and 2301c cut in the rinse plate 2300 are designed to equalize the flow of rinse liquid into each lumen from the pores, thereby ensuring that adequate flow of rinse liquid is provided to both of the lumen of thrust shaft 3210 and supply shaft lumen 3216. Turning to Figure 24A, in some embodiments, a hemostatic seal (such as the hemostatic seal 2400 illustrated in Figures 26A and 26B) is used to seal around the cut portion 1508 of the proximal section 1504 of the sleeve shaft 1500, near of the sleeve actuation handle 2208. Figure 26A illustrates a hemostatic seal 2400 according to various embodiments. As seen in Figure 26A, the hemostatic seal 2400 may have an opening 2406 in the shape of a cross section of the cut section 1508 of the sleeve shaft 1500, such as a U shape or a ring. 185 incomplete (e.g., partial), configured to receive the cut portion 1508 therein and to seal on all sides of the sleeve shaft 1500. Figure 26B illustrates the hemostatic seal 2400 in operation and disposed within the straight section 2202 of the hub assembly 2230, according to many embodiments. In some embodiments, as shown in Figure 26B, two rigid washers 2402 and 2404 may support each end of the hemostatic seal 2400. The rigid washers 2402, 2404 may have the same profile as the hemostatic seal 2400 to maintain the integrity of the seal. hemostatic seal 2400. In various embodiments, the washers 2402. 2404 exert inward pressure on the hemostatic seal 2400 to ensure a seal between the hemostatic seal 2400 and the cut portion 1508 of the sleeve shaft 1500. Turning to Figure 24A, this seal Hemostatic device 2400 may be located near the cuff actuation handle 2208, such as at point 2212 in many embodiments. By placing the hemostatic seal 2400 near the sleeve actuation handle 2208, some embodiments will incorporate a closure cap assembly 2214 in the handle assembly 2200 to allow adjustment of the inward pressure placed on the hemostatic seal, in order to blocking and / or immobilizing the sleeve shaft 1500 (e.g., from axial translation with respect to a remainder of the hub assembly 2230 and the thrust shaft 1900) by applying additional pressure on 186 the shaft sleeve. As shown in Figures 24A and 24B and presented above, the delivery system may include a suture closure assembly 2206 located on the branch 2204 of the hub assembly 2230 of the handle assembly 2200. Figures 27A-29D show embodiments of a ratchet suture closure 2700 that can be used as the suture closure assembly 2206 of the delivery system 2220 of Figures 24A and 24B. The hub assembly 2230 can be adapted and configured to allow the proximal extension of a thrust shaft (e.g., the proximal extension 1910) to extend to the suture closure 2700 at the end of the branch 2204, while the shaft of sleeve (e.g., sleeve shaft 1500) extends to a drive sleeve 2208 at the end of the straight section 2202 (e.g., as shown in Figure 27A). Additional embodiments of the hub assembly that include suture closure 2700, as shown in Figure 27A, include a flush line 2216 to allow discharge of one or more lumens within the delivery device (e.g., the lumen of supply shaft 3216) to maintain hemostasis within the delivery device and / or sterilize a delivery device (as described above with reference to Figures 35-38). As with the system illustrated in the figures 187 24Α and 24B, a medical professional operates the deployment of the docking device by manipulating the position of the handle assembly 2200 and only adds an additional step to retract the cuff by pulling back on the cuff drive handle 2208. The sleeve assembly and the pusher assembly may be configured to work together so that they can move simultaneously when deploying and positioning the coupling device on the native valve (for example, moving the entire hub assembly and / or connector in a Y forward and / or backward), but also to move independently so that the pusher / thrust shaft can hold the coupling device in position while the sleeve is removed from the coupling device (e.g. by holding the hub assembly and / or Y-shaped connector in place with respect to the main shaft of the delivery system and / or other parts of the delivery system and / or coupling device while pulling proximally on the sleeve drive handle 2208 to remove the sleeve). The sleeve shaft and thrust shaft may be coaxial through part, all or most of the delivery system to facilitate this work together, as explained above. As shown in Figures 27A-28A and 29C, suture closure 2700 of many embodiments comprises a 188 rotator 2702 (may also be referred to as rotating handle) to increase and decrease tension in a suture 2812 (shown in Figures 28B-28D) that can extend from the suture closure 2700. through the branch 2204, and through the system supply to connect to the coupling device (for example, similar to release suture 2236 shown in Figures 24B and 34). In many embodiments, suture 2812 is wrapped around a spool 2930 of suture closure 2700 (Figures 27C, 29C and 29D). The rotator (e.g., handle) 2702 may be attached to the spool 2930, such that the rotator 2702 rotating in a given direction will adjust the tension (e.g., increase or decrease) the tension in the suture 2812 passing through the delivery device. (e.g. supply system 2220). Providing tension or slack to the suture 2812 by rotating the rotator 2702 (and therefore the spool 2930) may move the coupling device closer or further away from the delivery system, respectively. As shown in Figure 27B, in some embodiments, the rotator 2702 may include one or more gripping portions or grips that increase the ease of gripping the rotator 2702 (e.g., through a user's hand), without slipping. . For example, the rotator 2702 may include a first gripping portion 2703 disposed around a circumference of the rotator and which is configured to be 189 gripped by a user during rotation of the rotator 2702. In some embodiments, the first grip portion 2703 may include a plurality of ridges to increase traction and ease of grip. The rotator 2702 may further include a second grip portion 2701 disposed on a top surface of the rotator 2702. Additionally, in some embodiments, the first grip portion 2703 and / or the second grip portion 2701 may comprise a material that has a durometer lower (e.g. reduced hardness). In some embodiments, the suture closure 2700 may further include a directional control mechanism that may include a directional selector 2704 (e.g., in the form of a switch, as shown in Figures 27A27C) that allows a physician or other user select whether to increase or decrease the slack in suture 2812 passing through the delivery device. For example, the multi-modality directional selector 2704 will allow a clinician or other user to select a direction (e.g., increase or decrease tension), which will allow the rotator 2702 to rotate in a single direction to avoid incorrect direction for a doctor or other user. For example, as shown in Figure 27C and 29A, the reel 2930 may include a gear 2902 that can be engaged with a ratchet 2904 that allows rotation of the gear 2902 and, therefore, the rotator 2702 and the reel 190 2930, in one direction. The direction in which the rotator 2702 can be rotated depends on the orientation of the pawl 2904, which is controlled by the directional selector 2704. In some embodiments, as shown in Figures 27A and 27C, an upper housing 2710 may include a first icon 2706 indicating a loose position of the directional selector 2704 and a second icon 2708 indicating a tension position of the directional selector 2704. As shown in Figure 29A, in some embodiments, the directional control mechanism may be a ratchet mechanism that limits directional movement from the rotator 2702 by a clinician or other user. As shown in Figures 27B, 27C and 29A, gear 2902 is attached to rotator 2702, while pawl 2904 is attached to directional selector 2704. Ratchet 2904 can be designed to engage teeth 2910 of gear 2902 so that Gear 2902 can only rotate in one direction at a time. When the pawl 2904 is actuated (e.g., pivoted) to a position (e.g., tight or loose), a spring plunger 2906 engages the back of the pawl 2904, thereby holding the pawl 2904 in the selected direction / position. (as shown in Figures 27C and 29A). When engaged in one direction, one or more teeth 2908 of the ratchet 2904 interact with the teeth 2910 on the gear 2902. Additionally, a 191 stop 2912 to prevent the pawl 2904 from moving bidirectionally, thus allowing the gear 2902 to move only in one direction. The stop 2912 can be constructed in various ways, including making it part of the upper housing 2710 or adding additional materials (e.g., pins, spacers, etc.) within the housing 2710 to prevent bidirectional movement of the ratchet 2904. Figure 29E is a graph 2950 illustrating exemplary operation of the directional control mechanism shown in Figure 29A. As shown in Figure 29E, when the directional selector 2704 is in the free position (for example, pointing at the first icon 2706, as shown in Figure 27A), when the rotator 2702 is rotated counterclockwise, the Ratchet 2904 is pushed clockwise by gear 2902 to allow rotation (as shown in frame 2952 of chart 2950). When the teeth 2910 of the gear 2902 pass over the tooth 2908 of the ratchet 2904, the spring plunger 2906 pushes the ratchet 2904 counterclockwise to mesh with the next gear tooth of the gear 2902. When the rotator 2702 rotates clockwise (e.g. 29A and chart 192 2954 of graph 2950). As introduced above, this hard stop 2912 prevents further rotation of the spool 2930 and prevents the load from resisting rotation in place of the tooth 2908 of the ratchet 2904. When the directional selector 2704 is moved to the tension position, the spool 2930 will only can be rotated clockwise due to the same mechanisms described above for the slack position (as shown in charts 2956 and 2958 of chart 2950). In some embodiments, the hard stop 2912 is designed to engage while the spring plunger 2906 is still engaged with the pawl 2904, which may prevent a loose feeling in the directional selector 2704 while at rest. Figures 29B-29D show additional embodiments of a directional control mechanism for a suture closure, such as suture closure 2700, which includes a clutch system. The clutch system can be configured to limit the amount of tension that can be applied to the suture (e.g., 2812 suture) and prevent potential damage or degradation of the delivery system and / or coupling device. Turning to Figure 29B, a directional control mechanism having a clutch that disengages the spool 2930 from the rotator 2702 and that uses friction pads to transfer torque from the rotator 2702 to the spool 193 2930 is illustrated according to some embodiments. In particular, Figure 29B illustrates a cross-sectional side view of a portion of a suture closure (e.g., suture closure 2700) wherein the rotator 2702 is connected to a central screw 2916 and a friction control nut 2918. It is connected near the distal end of the central screw 2916. The central screw 2916 extends through a center of the spool 2930 and is coupled to the spool 2930. The friction pads 2920 are arranged around the central screw 2916, above and below of a central portion of the spool 2930, so that the rotator 2702 rotating too much in one direction will cause greater friction in the central screw 2916, so that further rotation will be prevented. For example, when the tension in the suture reaches a predetermined threshold, the increased friction of the friction pads 2920 may prevent the spool 2930 from rotating when the rotator 2702 is rotated. In alternative embodiments, as shown in Figures 29C-29D, a pin-based clutch system used in certain embodiments is illustrated. In such embodiments, a spring piston 2922 transfers torque from the rotator 2702 to the spool 2928 (which may be similar to the spool 2930). Spring plunger 2922 rests on (e.g., engages with) detents 2924 on gear 2926 (which may be similar to gear 2902 and used as 194 similarly) to allow actuation of spool 2928 to increase or decrease tension on a suture. The detents 2924 may be disposed on an outward facing surface of the gear 2926, where a line perpendicular to the outward facing surface is disposed perpendicular to a circumferential surface of the gear that includes the teeth of the gear. At a designed suture tension (e.g., tension above a predetermined threshold), the spring plunger 2922 can slide out of one of the retainers and move to an adjacent (e.g., next) retainer 2924. In this way , when the rotator 2702 is rotated further at a certain point, the spring plunger 2922 retracts, thereby preventing further rotation of the rotator 2702 and reducing degradation of the coupling device and / or delivery system due to too much tension being applied in the suture. Degradation of the coupling device and / or delivery system can only be a risk when tension is applied to the suture. Therefore, the detents 2924 can be designed to slide only in the tension configuration and cannot slide in the slack configuration. Returning to Figures 27A-27C and 28A-28B, in some embodiments, the suture closure may include a connector or connecting portion for attaching the suture closure 2700 to a handle assembly (e.g., handle assembly 2200 of 195 figure 27A). For example, suture closure 2700 may include a release bar 2820 that extends and engages a lower housing 2712 of suture closure 2702 (FIGS. 27B-28C). In some embodiments, the release bar 2820 is attached to the lower housing 2712 (e.g., by an adhesive, welding, or other non-removable attachment means). As shown in Figures 27B and 28A-28C, a release button 2802 may be arranged around a portion of the release bar 2820 adjacent to a connecting portion 2822 of the lower housing 2712. The release button 2802 is can be configured to connect the suture closure 2700 to a delivery system adapter 2270. In some embodiments, as shown in Figure 27A, the adapter 2270 may include the branch 2204 and the straight portion 2202, as discussed above. For example, release knob 2802 may be screwed into one end 2272 of adapter 2270 to secure suture closure 2700 to adapter 2270. In some embodiments, the shape, size and / or configuration of adapter 2270 may be different than shown in Figure 27A and may change depending on the delivery system with which the suture closure 2700 is configured to engage (and be used). For example, in some embodiments, when the teeth of the release button 2802 engage both the 196 end 2272 of the adapter 2270 (or other adapter of a release system) as to the release bar 2820, the suture closure 2700 is coupled to the delivery system and a suture cutting section 2804 is covered by the adapter 2270 ( as shown in figures 27A, 28B and 28C). In some embodiments, once the docking device (or other implant) is placed in the desired position for release from the delivery system, the release knob 2802 can be unscrewed, toward the lower housing 2712 and the suture closure 2700 can be unscrewed. can be pulled proximally away from the adapter (e.g., delivery system adapter) 2270 to expose a suture cut section 2804. In alternative embodiments, rotation of the release button 2802 toward the lower housing 2712 can expose the cut section of suture 2804 without pulling the entire suture closure 2700 away from the adapter 2270. Suture cutting section 2804 allows a user or clinician to cut a suture 2812 that traverses the length of a delivery system (e.g., as shown as suture 2236 in Figures 24B and 34), to allow disconnection of a delivery system coupling device after installation in a heart or heart analog. In some embodiments, once the suture 2812 is wrapped around the coupling device or 197 implant (for example, as shown in Figures 24B and 34) and is routed through the delivery system, through the release bar 2820 (including through the suture cutting section 2804, such as shown in Figure 28B), and in the lower housing 2712, the two suture ends of the suture 2812 can be threaded through the two openings 2932 arranged at a lower end of the spool 2930 (or 2928 of Figure 29D) and then tie to complete the loop. As shown in Figure 29D, the spool 2928 (or 2930) may include a gap 2934 in a tab at the bottom of the spool 2928 that may prevent the suture 2812 from being crushed during assembly of the upper housing 2710 and the lower housing. 2712. In some embodiments, as shown in Figure 27A, the rotator 2702 may include an indicator 2714 to track a number of turns applied and locate the space of the spool 2934. In many embodiments, as shown in Figures 28C and 28D, the suture 2812 passes longitudinally through the release bar 2820 of the suture closure 2700 and the two lines of the suture are divided at the transverse divider 2814 disposed in the suture cutting section 2804. Various embodiments use the divider 2814 to separate the suture lines 2812 so that a user or doctor can cut only one line to release a ινΐΛ / a / zuz i / un device. 198 coupling of the delivery device. For example, the exposed portion of suture 2812, as shown in Figure 28D, can then be cut by a cutting mechanism, such as the cutting mechanism of Figures 30A-30C. Once the suture is cut, it can be removed from the delivery system and the suture closure 2700 can be replaced into the delivery system adapter 2270 by screwing the release button 2802 into the adapter 2270. Additional embodiments maintain a seal within the suture closure 2700 using a plurality of annular sealing elements (e.g., tonic seals) 2816a-c to prevent leakage of blood, saline or other fluid through the system. For example, as shown in Figures 27C, 28C, 29B and 29C, the suture closure 2700 may include a first distal release bar O-ring 2816a (Figures 27C and 28C), a second release bar O-ring proximal 2816b (Figures 27C and 28C) and a spool O-ring 2816c (Figures 27C, 29B and 29C). These O-rings 2816a-c can be configured to seal the suture path when the suture closure 2700 is assembled, allowing for hemostasis when connected to a properly sealed delivery system. The O-ring on the 2816c spool can prevent leakage beyond the end of the suture path. The proximal release bar 2816b O-ring can prevent leakage between the release bar 2820 and 199 the lower housing 2712. In some embodiments, this allows an adhesive or other bonding agent that adheres the release bar 2820 to the lower housing 2712 to act solely as a bond and does not require a sealing function. The distal release bar O-ring 2816a can prevent leaks between the release bar 2820 and the delivery system adapter 2270 while the release button 2802 is engaged. The release knob 2802 may be designed so that the O-ring of the distal release bar 2816a seals the suture closure mechanism when there is some threaded engagement with the adapter 2270 (for example, there may not be a variable seal depending on how tight the release knob is). In some embodiments, there may be a hole in the lower housing 2712 to act as a leak path in the event of seal degradation. As introduced above with reference to Figure 38, additional embodiments of the suture closure 2700 comprise a flushing port 2806 to allow flushing of one or more lumens within the delivery device to reduce thrombus formation between components of the suture system. delivery, maintain hemostasis within a delivery device and / or sterilize a delivery device. Flush port 2806 allows certain embodiments of a delivery device to flush lumens independently if a single line of 200 flush clogs and / or does not maintain hemostasis in a delivery device. In certain embodiments, the rinse port 2806 is an open port to allow a constant flow through a delivery device, while certain embodiments have a self-sealing rinse port 2806 so that fluids can be introduced into a delivery device according to a doctor needs it without requiring a constant flow. A rinse port 2806 as illustrated in Figure 28A allows an additional rinse line similar to be connected to several rinse ports, as illustrated in Figure 24B and discussed above. Turning to Figures 28B and 28D, some embodiments of the suture closure 2700 have segments that are keyed to prevent rotation of a suture closure 2700 around a handle assembly, thereby preventing twisting of the suture lines and / or increasing ease of access for a doctor. Keying of certain components of the suture closure 2700 can be achieved in various ways, including creating a specific non-round shape in the components, using pins, slots or any other methodology to maintain a non-rotating fit between the suture closure 2700 and a outer casing or handle assembly. For example, in some embodiments, as shown in Figure 28B, either end of the release bar can be shaped to form keyed connections 2808a and WUUa / 2U21 / Ul 4200 201 2808b between the release bar 2820 and the lower housing 2712 and the release bar 2820 and the adapter 2270, respectively. For example, a proximal end 2824 of the release bar 2820 may be shaped to form the first keyed connection 2808a and a distal end 2826 of the release bar 2820 may be shaped to form the second keyed connection 2808b. In some embodiments, as shown in Figures 28D, the release bar 2820 may include one or more support ribs 2828 arranged on a central portion of the release bar, the central portion disposed between the distal end 2826 and the end proximal 2824 of the release bar 2820. For example, in some embodiments, the support ribs 2828 may include a plurality of axially extending ribs 2828 that are arranged around a circumference of the release bar 2820, on each side of a central ring member 2830 extending around the circumference of the release bar 2820. Figures 30A-30C illustrate a suture cutting and removal system used in various embodiments. Such embodiments allow a user to cut and remove a suture, such as suture 2812 shown in Figures 28B-28E without breaking the hemostasis of a system or relying on a scalpel or other cutting method to cut a suture. In particular, the 202 Figure 30A illustrates a rest position with a cutting actuator 3002 attached to a blade 3004 and a suture removal actuator 3006 attached to a loop 3008 or hook attached to the suture 2812. Figure 30B illustrates the cutting of the suture 2812. pressing cutting actuator 3002 to cut suture 2812. Figure 30C illustrates suture removal by removing suture removal actuator 3006, which draws suture 2812 using loop 2008 from within a delivery device. Supply system packaging As discussed above, many embodiments use a coating, a lubricating coating, and / or a hydrophilic coating, such as a hydrogel, on the lubricating sleeve covering the coupling device. In some embodiments, the coupling device itself may have a coating. After manufacturing, the docking devices and delivery systems will be transported for use. During transport or storage, the environment may change over time, for example with different weather patterns and / or geographic locations. These environmental changes can include changes in humidity. However, many hydrophilic coatings can absorb moisture from the environment. As delivery devices are transported or stored, the hydrophilic coatings may go through one or more wet and dry cycles. 203 Due to wet-dry cycles, hydrophilic coatings on adjacent coils may stick together. Other coatings may also be prone to sticking together on adjacent coils. Coils that stick together can be problematic when preparing or loading the coupling device into the delivery system for use. Thus, certain embodiments of the invention are directed to packaging for delivery systems and coupling devices as described herein. Turning to Figures 31A and 31B, a coil holder 3100 is illustrated in accordance with various embodiments. As seen in Figure 31A, a series of fins 3102 protrude from a central pillar 3104. In many embodiments, the fins 3102 separate individual turns or coils of a coupling device or a sleeve coupling device. By separating the individual coils or turns from each other, the coils will not be able to stick together, should they be subjected to wet-dry cycles during storage or transportation or otherwise. Adjacent fins 3102 in various embodiments are separated by a distance sufficient to allow a single turn of a sleeve coupling device to be placed between them. Additionally, the coil holder 3100 in many embodiments includes a central opening 3106 formed in the central pillar 3104. In various embodiments, the central opening 3106 can be used to attach the coil holder. 204 coil 3100 to an outer packaging, which may have a complementary protrusion in which to mount the coil holder 3100 using the central opening 3106. In some embodiments, the coil holder 3100 comprises a central opening that has an irregular shape, such as a winged circle, as illustrated in Figure 31B, or other feature that will prevent the coil holder 3100 from rotating in the outer packaging. Additionally, the coil holder 3100 may be made of any material suitable for maintaining separation of individual coils and preventing the coils from sticking or agglomerating, including plastics and polymers, such as a hollywood homopolymer. The 3100 coil holder, when mounted on the outer packaging, may be placed in a low point or reservoir formed in the outer packaging. In some embodiments, the packaging and location and alignment of the coil holder 3100 is configured to allow preparation and loading of the sheathed coupling device (e.g., retracting the sheath and the coupling device into an outer catheter or outer sheath of the delivery system) to occur without removing the delivery device from the outer packaging or while it is in its packaged position. Methods The present invention provides methods for delivering implants into the native valves of a heart. 205 The methods can be used to deliver any of the implants described herein, including coupling devices having aspects thereof shown in Figures 7A to 16 and are further described elsewhere herein. The methods may comprise placing the selected coupling device on the native valve of the heart, such that at least a portion of the main turn of the coupling device is placed in a ventricle of the heart and around one or more leaflets of the native valve. . In some implementations, implantation of the docking device may act to remodel one or more tissues in the heart to repair native valve function. In certain implementations, the methods may comprise delivering the coupling device to a native mitral valve to repair the left ventricle and associated cardiac function. In other implementations, the methods may reduce the diameter of the ring and place tension on the strings. In other implementations, the methods may further include performing an edge-to-edge repair on the native leaflets of the native valve, such as, for example, placing a clip to secure a free edge of an anterior mitral valve leaflet to a free edge of a posterior mitral valve leaflet. In some implementations, the methods can 206 comprise placing an implantable prosthetic heart valve within the coupling device after the coupling device is placed on the native heart valve in the desired position. The methods can be used to deliver any of the implantable prosthetic heart valves described herein, including valves having aspects thereof shown in Figures 3A to 6 and further described elsewhere herein. In some implementations, suitable implantable prosthetic heart valves that can be used in the methods may have an annular frame with an inflow end and an outflow end that is radially collapsed and expanded between a radially collapsed configuration and a radially collapsed configuration. radially expanded, with the frame defining an axial direction extending from the inlet flow end to the outlet flow end; a shell structure placed within the frame and secured thereto; and a flange attached to the inlet flow end of the annular frame and designed to extend outwardly therefrom. In certain implementations, the methods may further comprise placing the implanted prosthetic heart valve in a radially collapsed configuration within the coupling device and expanding the implanted prosthetic heart valve from the radially collapsed configuration to a 207 radially expanded configuration, such that pressure is applied radially outward by the frame of the implanted prosthetic heart valve in at least a portion of a central region of the coupling device. In some aspects, the present invention further provides methods of delivering coupling devices using the delivery systems described elsewhere herein, including delivery systems having aspects thereof shown in Figures 17A-29E and 33- 38. In certain implementations, delivery systems suitable for use in the methods may include a delivery catheter, the coupling device with an end portion at the end of the stabilization loop located opposite the central region, a thrust shaft arranged in the delivery catheter and coupled to the end portion of the coupling device and a sleeve shaft located coaxially with the thrust shaft and disposed between the delivery catheter and the thrust shaft. In some implementations, the delivery system can be configured so that the thrust shaft and the sleeve shaft operate in parallel. In certain implementations, the positioning step of the methods may comprise pushing the coupling device away from the catheter with the pushing shaft. In some implementations, the method positioning step may comprise using the pusher to hold 208 the coupling device in place while a cuff and / or catheter are removed from the coupling device. Figure 39 illustrates a flow chart of a method 3300 for delivering a coupling device to a native valve of a heart and implanting the coupling device and an associated prosthetic heart valve into the native valve. Method 3300 begins at 3302 and may include advancing a distal end portion of a delivery system to a native valve of a patient's heart, the delivery system being configured to deliver and implant a coupling device disposed within the end portion. distal and covered by a section of a sleeve shaft of the delivery system. The delivery system may be one of the delivery systems described herein, including the delivery system components described above with reference to Figures 17A-29E. The coupling device may comprise a coil extending along a central axis and including a central region including a plurality of turns, an input turn extending from a first end of the central region and a stabilizing turn. extending from a second opposite end of the central region, wherein a cover extends around and along an upper loop of the central region, the upper loop disposed at the second end of the central region. For example in 209 in some embodiments, the coupling device may be one of the coupling devices described herein with reference to Figures 9A-12E. Furthermore, in some embodiments, the cover extending around and along the upper turn of the central region may be the cover 100 shown in Figure 12E. In some embodiments, the native valve may be a mitral valve of the heart. At 3304, method 3300 may include deploying the coupling device from a distal end of the delivery system, the coupling device covered by a distal section of a sleeve shaft of the delivery system. As described herein with reference to Figures 17A-29E and 33-37, deploying the coupling device may include pushing the covered coupling device off the outer axis of the delivery system with the thrust axis of the delivery system. For example, pushing the coupling device off the outer axis with the thrust shaft may include actuating the thrust shaft to extend distally (along the axial direction) away from the outer axis of the delivery system, in response to a user moving the hub assembly and / or the handle assembly in the distal direction. As a result, both the thrust shaft and the sleeve shaft can move axially together, in the distal direction, away from the outer shaft. 210 The method at 3304 may further include placing the covered coupling device on the native valve (for example, the mitral valve 10 shown in Figures 1 and 2), so that the cover of the upper turn of the central region crosses and plugs a medial commissure (for example, the right lower commissure 24 shown in Figure 2) of the native valve, at least a portion of the main turn is placed in a ventricle of the heart (for example, the left ventricle 14 which is shown in Figure 1), and at least a portion of the stabilization coil is placed in an atrium of the heart (for example, the left atrium 12 shown in Figure 1). During advancement, deployment and positioning of the covered coupling device, as introduced above and shown in Figures 33 and 17B, a distal tip of the distal section of the sleeve shaft may extend distal to (e.g., beyond) a distal end of the docking device, thereby providing the distal section of the sleeve shaft with a more atraumatic tip that can deform and bend as it navigates the native anatomy. The method at 3306 may include, during deployment, discharging one or more lumens from the delivery system. The one or more lumens may include a first lumen disposed between the distal section of the sleeve shaft and the 211 coupling device and a second lumen disposed between an outer shaft of the delivery system and the sleeve shaft, as described above with reference to Figure 38. In some embodiments, rinsing the first lumen may include providing rinsing fluid to a thrust shaft lumen extending across a thrust shaft from a proximal end of the thrust shaft disposed within a branch section of an assembly. hub, wherein a suture closure is coupled to the branch section, to a distal end of the thrust shaft, the distal end disposed close to, but spaced from, a proximal end of the coupling device. Flushing the first lumen may further include flowing flushing fluid through the thrust shaft lumen and into and through the first lumen. In some embodiments, flushing fluid may be provided to the thrust shaft lumen through a flushing port coupled to the branch section, distal to the suture closure. In alternative embodiments, flushing fluid may be provided to the thrust shaft lumen through a flushing port that is part of the suture closure and is disposed at a proximal end of the suture closure. In some embodiments, rinsing the second lumen may include providing rinsing fluid to a first 212 cavity (for example, cavity 2254 shown in Figure 36) formed between an outer surface of the thrust shaft and an inner surface of a conduit of the branch section, wherein the flushing fluid flows from the first cavity to a second cavity (for example, cavity 1946 shown in Figure 37) formed between a thrust shaft housing and the sleeve shaft, and flowing flushing fluid from the second cavity to the second lumen. In some embodiments, flushing of the lumens of the delivery device, as described above, may additionally occur during preparation of the delivery device for an implantation procedure, prior to inserting the delivery device into a patient. At 3308, method 3300 may include, after positioning the covered coupling device, retracting the sleeve shaft, in a proximal direction, to uncover the coupling device. In some embodiments, retracting the sleeve shaft to uncover the coupling device may include moving a sleeve actuation handle of the delivery system in the proximal direction. The method at 3308 may further include maintaining a position of the thrust shaft while retracting the sleeve shaft to uncover the coupling device and, after uncovering the coupling device, retracting the sleeve shaft. 213 thrust towards the outer shaft of the supply system. Method 3300 may continue to 3310 to release (e.g., disconnect) the coupling device from the supply system. As described herein, the delivery system may include a suture closure assembly (e.g., suture closure 2206 of Figure 24A and / or suture closure 2700 of Figures 27A-29E) that includes a suture cutting location for cutting a suture (or other recovery line) that extends from the suture closure, through the delivery system, and loops around one end of the docking device. In some embodiments, as described above with reference to Figures 27A30C, the method at 3310 may include exposing the suture cutting location of the suture closure and using a cutting mechanism (such as the mechanism shown in the Figures 30A30C) to cut the suture and then remove the suture from the docking device. As a result, the coupling device may become disconnected from the supply system. At 3312, method 3300 may include deploying a prosthetic heart valve (e.g., one of the valves shown in Figures 3A-8) within the implanted coupling device, as described herein. A method of supplying a device 214 coupling according to certain embodiments is illustrated in Figures 32A-32C. Figure 32A illustrates the delivery of a coupling device that includes a cover 100. In particular, Figure 32A illustrates the initial retraction of a sleeve or distal section in a delivery device. However, the cover 100 is not fully expanded and extends over part of the thrust shaft 1900. In this way, Figure 32B illustrates the partial reinsertion of the sleeve or distal section 1502 to push the cover 100 in an expanded form, and Figure 32C illustrates a complete retraction of the sleeve or distal section in a delivery device with the cover 100 in expanded form and no longer covering the thrust shaft 1900. Additional steps described elsewhere in this document may also be added and the systems and assemblies described in this document may be used with these methods. Each and every method, operation, step, etc. described in this document can be carried out on a living animal or a non-living corpse, cadaver heart, simulator (e.g. with body parts, tissue, etc. being simulated), anthropomorphic ghost, etc. General considerations For the purposes of this description, certain aspects, advantages and novel features of embodiments of this invention are described herein. 215 The methods, apparatus and systems described should not be construed as limiting in any way. Instead, the present invention is directed to all the novel and non-obvious features and aspects of the various described modalities, alone and in various combinations and subcombinations with each other. The methods, apparatus and systems are not limited to any specific aspect or characteristic or combination thereof, nor do the described embodiments require that one or more specific advantages be present or that problems be solved. Although the operations of some of the described embodiments are described in a particular sequential order for convenient presentation, it should be understood that this form of description encompasses reordering, unless a particular order is required by the specific language set forth below. For example, operations described sequentially may, in some cases, be rearranged or carried out at the same time. Additionally, for the sake of simplicity, the accompanying figures may not show the various ways in which the methods described can be used in conjunction with other methods. Additionally, the description sometimes uses terms such as provide or achieve to describe the methods being disclosed. These terms are high-level abstractions of the actual operations taking place. The actual operations that correspond to these terms can 216 vary depending on the particular implementation and are easily discernible by one skilled in the art. As used in this application and the claims, the singular forms a, an and the / the include the plural forms unless the context clearly indicates otherwise. Furthermore, the term includes means comprises. Furthermore, the terms coupled and associated generally mean electrically, electromagnetically, and / or physically (e.g., mechanically or chemically) coupled or linked and do not exclude the presence of intermediate elements between the coupled or associated elements in the absence of specific contrary language. In the context of this application, the terms lower and upper are used interchangeably with the terms input and output, respectively. So, for example, the lower end of the valve is its inlet flow end and the upper end of the valve is its outlet flow end. As used herein with reference to delivery systems, docking devices, and prosthetic heart valves, the term proximal refers to a position, direction, or part of a device that is closest to the user and / or a handle of the system. supply that is arranged outside the patient and further away from the implantation site. As used in this document, the term 217 distal refers to a position, direction or portion of a device that is further from the user and / or the handle of the delivery system and closer to the site of implantation. Thus, for example, proximal movement of a device is the movement of the device toward the user, while distal movement of the device is movement of the device away from the user. The terms longitudinal and axial refer to an axis that extends in the proximal and distal directions, unless expressly defined otherwise. Furthermore, the term radial refers to a direction that is arranged perpendicular to the axis and points along a radius from the center of an object (where the axis is placed at the center, such as the central longitudinal axis of the system of supply). 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 only preferred examples and should not be taken as limiting the scope of the invention. Rather, the scope of the invention is at least as broad as the following claims. It is stated that in relation to this date, the best method known to the applicant to put the aforementioned invention into practice is the one that is clear from the present description of the invention.
Claims
1. A suture closure assembly for a delivery system of an implantable medical device, characterized in that it comprises: a spool configured to receive a suture and including a gear; a rotary handle coupled to the spool and configured to rotate the spool and the gear; a ratchet configured to engage with the teeth of the gear and allow rotation of the gear, spool, and handle in one direction only; and a directional selector coupled to the ratchet and movable between two positions, wherein each of the two positions corresponds to a different direction of rotation of the gear, the directional selector being configured to pivot the ratchet to adjust an orientation of the ratchet relative to the gear and adjust a direction of rotation of the gear.
2. The suture closure assembly according to claim 1, characterized in that the ratchet can pivot 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 a second opposite direction.
3. The suture closure assembly according to claim 2, characterized in that the first direction is counterclockwise and the second direction is clockwise.
4. The suture closure assembly according to any of claims 2 and 3, characterized in that the ratchet is held in the first orientation and the second orientation by a spring plunger coupled with the ratchet at the rear of the ratchet and wherein in the first orientation the ratchet is arranged on a first side of the spring plunger and in the second orientation the ratchet is arranged on a second side of the spring plunger.
5. The suture closure assembly according to claim 4, characterized in that the ratchet includes two teeth separated from each other and arranged on a front side of the ratchet and wherein the two teeth of the ratchet are configured to engage with the teeth of the gear.
6. The suture closure assembly according to any of the preceding claims, characterized in that it further comprises hard stops arranged within a housing of the suture closure assembly, the gear and ratchet arranged within the housing, and wherein the ratchet is configured to interact with one of the hard stops when the gear is rotated in a direction opposite to a selected rotation direction set by the directional selector.
7. The suture closure assembly according to any of the preceding claims, characterized in that it further comprises a housing including an upper housing and a lower housing coupled together, the gear and ratchet disposed within a space arranged between the upper housing and the lower housing, and the rotary handle and directional selector extending outward from the upper housing, wherein the upper housing includes a first icon indicating a slack position of the directional selector and a second icon indicating a tension position of the directional selector, and wherein the directional selector is movable between a first of the two positions pointing towards the first icon and a second of the two positions pointing towards the second icon.
8. The suture closure assembly according to any of the preceding claims, characterized in that it further comprises a release bar including a suture cutting location disposed at a distal end of the release bar, the release bar configured to receive a suture through the inside of the release bar and through the suture cutting location, wherein the suture extends from the spool.
9. The suture closure assembly according to claim 8, characterized in that the release bar includes one or more support ribs arranged in a central portion of the release bar, the central portion being arranged between the distal end and the proximal end of the release bar.
10. The suture closure assembly according to any of claims 8 and 9, characterized in that the distal end of the release bar is shaped to form a first keyed connection with a supply system adapter and a proximal end of the release bar is shaped to form a second keyed connection with a lower housing of the suture closure assembly, wherein the spool is disposed within an interior of the lower housing.
11. The suture closure assembly according to claim 10, characterized in that it further comprises a rinsing 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. WUUa / 2U21 / Ul 4200 222 12. The suture closure assembly according to any of claims 8-11, characterized in that it further comprises a plurality of annular sealing elements, including a first annular sealing element disposed around a distal end portion of the release bar, near the suture cutting location, and a second annular sealing element disposed around a proximal end portion of the release bar, the second annular sealing element being disposed between, in a radial direction, the release bar and a lower housing of the suture closure assembly, wherein the spool is disposed within the lower housing.
13. The suture closure assembly according to claim 12, characterized in that the plurality of annular sealing elements further includes a third annular sealing element disposed around a portion of the reel and disposed between the reel portion and the lower housing.
14. The suture closure assembly according to any of claims 8-13, characterized in that a proximal end of the release bar is attached to a lower housing of the suture closure assembly.
15. The suture closure assembly according to any of claims 8-14, characterized in that the release bar includes a divider disposed 223 within the suture cutting location, wherein the divider is configured to separate two lines of a suture extending longitudinally through the release bar and expose only one line of the two suture lines to the outside of the suture closure assembly at the suture cutting location.
16. The suture closure assembly according to any of the preceding claims, characterized in that the spool includes a space in a flange disposed around the bottom of the spool and wherein the rotating handle includes an indicator on its outer surface configured to follow a series of turns applied to the spool and locate the space.
17. The suture closure assembly according to claim 16, characterized in that the space is arranged adjacent to one or more openings arranged within the reel, the one or more openings being configured to route the suture from the inside of the reel to an outer surface of the reel that is configured to receive the suture thereon.
18. The suture closure assembly according to any of the preceding claims, characterized in that the rotating handle is coupled to the spool by means of a central screw extending longitudinally through the rotating handle and the spool, 224 further comprising one or more friction pads arranged around the central screw, adjacent to the central portion of the spool, and a friction nut coupled to the central screw, below a lower friction pad of the one or more friction pads, and wherein the one or more friction pads are configured to increase friction on the central screw to stop rotation of the central screw and the rotating handle when tension on the suture increases above a predetermined threshold.
19. The suture closure assembly according to any of claims 1-17, characterized in that it further comprises a pin-based clutch system including a spring plunger extending longitudinally through and coupled to a portion of a rotating handle, wherein the spring plunger includes an end extending toward the gear and configured to extend and engage with a plurality of retainers disposed on an outer surface of the gear to permit rotation of the gear by the rotating handle, and wherein the spring plunger is configured to slide out of the retainers in response to tension in the suture above a predetermined threshold.
20. A delivery system for placing a coupling device on a ring of a native valve 225 of a patient's heart, characterized in that it comprises: an outer shaft; a cuff shaft disposed at least partially within the outer shaft, wherein the cuff shaft comprises: a distal section configured to cover the coupling device, wherein the distal section comprises a flexible material with a lubricated outer surface; and a proximal section comprising a rigid material and including a tubular portion and a cut portion, wherein the cut portion has an open U-shaped cross-section; and a thrust shaft disposed at least partially within the outer shaft, wherein the thrust shaft comprises: a main tube disposed inside, in a radial direction related to a central longitudinal axis of the delivery system, the cuff shaft;an annular housing surrounding a proximal end portion of the main tube and separated from, in the radial direction, an outer surface of the main tube; and a proximal extension connected to and extending proximally from a proximal end of the main tube, near the housing, the proximal extension comprising a flexible material and extending along a portion of an inner surface of the cut portion of the proximal section of the sleeve shaft.
21. The delivery system according to claim 20, characterized in that the push shaft further comprises an annular plug disposed within the annular housing, at a proximal end of the housing and surrounding the main shaft, wherein the plug includes a crescent-shaped portion extending lengthwise and widthwise, filling a first portion of an annular space disposed between the main tube and the housing.
22. The delivery system according to claim 21, characterized in that the annular space includes a second portion that is open and not filled by the plug, wherein the proximal section of the sleeve shaft is configured to slide into the annular space, and wherein the cut portion of the proximal section is configured to slide through the second portion of the annular space.
23. The delivery system according to claim 22, characterized in that the tubular portion of the proximal section has an end surface at an interface between the tubular portion and the cut portion, the end surface being arranged perpendicular to the central longitudinal axis, and wherein the plug is configured to interact with the end surface of the proximal section and prevent the sleeve axis from moving further in the proximal axial direction.
24. The delivery system according to any of claims 20 to 23, characterized in that the sleeve shaft further includes a middle section disposed between the distal section and the proximal section of the sleeve shaft, the middle section forming a transition between the flexible material of the distal section and the rigid material of the proximal section.
25. The delivery system according to claim 24, characterized in that the sleeve shaft further includes a flexible polymer sleeve forming an outer surface of the distal and middle sections, the flexible polymer sleeve comprising the flexible material, an inner lining forming an inner surface of each of the distal and middle sections, and a rigid tube including a first section forming the entire proximal section and a second section forming a proximal part of the middle section.
26. The delivery system according to claim 25, characterized in that the rigid tube is a metal tube, wherein the second section includes a plurality of openings arranged around a circumference of the rigid tube, along the second section, and wherein the rigid tube is coupled to the inner lining 228 and the flexible polymer sleeve through a joining connection between the inner lining and the flexible polymer sleeve, through the plurality of openings.
27. The delivery system according to any of claims 20-26, characterized in that it further comprises a handle assembly including a handle portion and a hub assembly extending proximally from a proximal end of the handle portion, wherein the outer shaft extends distally from a distal end of the handle portion, and wherein the hub assembly includes an adapter having a straight section coupled to a suture closure assembly and a branching section coupled to the cuff drive handle.
28. The delivery system according to claim 27, characterized in that the suture closure assembly is the suture closure assembly according to any of claims 1-19.
29. The delivery system according to any of claims 27 and 28, characterized in that the proximal extension of the thrust shaft extends into and through a portion of the adapter's branching section.
30. The delivery system according to claim 29, characterized in that it further comprises a first rinsing port coupled to the branching section 229 of the adapter and fluidly coupled with an internal lumen of the proximal extension of the thrust shaft.
31. The delivery system according to claim 30, characterized in that it further comprises a second rinsing port coupled to the branch section, distal to the first rinsing port, and fluidly coupled with a lumen formed between an outer surface of the proximal extension and an inner surface of the branch section.
32. The delivery system according to claim 29, characterized in that it further comprises a first rinsing port coupled to a proximal end of the suture closure assembly and fluidly coupled with an internal lumen of the proximal extension of the push shaft and a second rinsing port coupled to the branching section, distal to the first rinsing port, and fluidly coupled with a lumen formed between an outer surface of the proximal extension and an inner surface of the branching section.
33. The delivery system according to any of claims 27-32, characterized in that the cut portion of the sleeve shaft extends into the straight section of the adapter and is coupled to the sleeve drive handle.
34. The delivery system according to any one of claims 20-33, characterized in that the thrust shaft and the sleeve shaft are coaxial with each other along the central longitudinal axis of the delivery system, and wherein each sleeve shaft and thrust shaft are configured to slide axially along the central longitudinal axis with respect to the outer axis.
35. The delivery system according to any of claims 20-34, characterized in that a distal section of the main thrust shaft tube includes a plurality of cuts therein, spaced apart along a length of the distal section, wherein the plurality of cuts are configured to increase the flexibility of the distal section of the main tube.
36. The delivery system according to claim 35, characterized in that the spacing between adjacent cuts of the plurality of cuts varies along the distal section and wherein the spacing between adjacent cuts increases from a distal end to a proximal end of the distal section.
37. A delivery system for placing a coupling device onto a patient's native heart valve ring, characterized in that it comprises: a handle portion; an outer shaft extending distally from a distal end of the handle portion; a cuff shaft extending through the inside of the outer shaft and configured to cover the coupling device; a push shaft including a main tube extending through the inside of the cuff shaft; and a hub assembly extending proximally from a proximal end of the handle portion, wherein the hub assembly comprises: an adapter coupled to the handle portion and including a first section and a second section branching from the first section, wherein a portion of the push shaft extends into the second section and a proximal section of the cuff shaft extends through the first section;a suture closure assembly coupled to a proximal end of the second section and configured to adjust tension on a suture extending from the suture closure assembly, through the thrust shaft, to the coupling device; a first flush port coupled to the second section and fluidly coupled to a first fluid flow lumen disposed within the inside of the thrust shaft and a second fluid flow lumen disposed between the cuff shaft and the coupling device; and a second flush port coupled to the second section and fluidly coupled to a third fluid flow lumen disposed between the outer shaft and the cuff shaft.
38. The delivery system according to claim 37, characterized in that it further comprises a sleeve drive handle disposed at a proximal end of the first section and coupled to an end of the proximal section of the sleeve shaft, the sleeve drive handle being configured to adjust an axial position of the sleeve shaft with respect to the outer axis.
39. The handle assembly according to any of claims 37 and 38, characterized in that the first fluid flow lumen extends through an interior of a proximal extension of the thrust shaft and an interior of the main tube of the thrust shaft, the main tube being coupled to the proximal shaft extension and extending through an interior of the outer shaft and the proximal extension extending through a portion of the outer shaft and into the second section.
40. The handle assembly according to claim 39, characterized in that the first fluid flow lumen extends to a distal end of the thrust shaft, the distal end being disposed adjacent to but separated from a proximal end of the coupling device when the coupling device is disposed within the outer shaft.
41. The handle assembly according to any of claims 39 and 40, characterized in that the second flush port is fluidly coupled to the third fluid flow lumen through an annular cavity disposed between a thrust shaft housing and the main thrust shaft tube, and a fourth fluid flow lumen formed between an outer surface of the proximal extension and an inner surface of the second section, the fourth fluid flow lumen being fluidly coupled to the annular cavity.
42. The handle assembly according to claim 41, characterized in that the third fluid flow lumen is disposed between an inner surface of the outer shaft and a distal portion of the sleeve shaft, the distal portion configured to cover the coupling device while the coupling device is disposed within the outer shaft and implanted in the native valve ring.
43. The handle assembly according to any of claims 41 and 42, characterized in that it further comprises a third rinsing port coupled to the handle portion and fluidly coupled to the annular cavity. 234 44. The handle assembly according to any of claims 37-43, characterized in that it further comprises a gasket disposed within and through the diameter of the second section, between where the first rinse port is coupled to the second section and where the second rinse port is coupled to the second section, wherein the gasket is configured to fluidly separate the first fluid flow lumen and the third fluid flow lumen from each other.
45. The handle assembly according to any of claims 37-44, characterized in that the first rinse port and the second rinse port are connected to a single fluid source.
46. The handle assembly according to claim 45, characterized in that the only fluid source is an infusion pump and wherein the infusion pump is coupled to the first rinse port and the second rinse port by means of a Y-connector.
47. The handle assembly according to any of claims 37-44, characterized in that the first rinse port and the second rinse port are connected to different fluid sources.
48. The handle assembly according to any of claims 37-47, characterized in that the first rinsing port is coupled directly to the second adapter section, away from the suture closure assembly and close to the second rinsing port.
49. The handle assembly according to any of claims 37-47, characterized in that the first flush port is part of the suture closure assembly and is disposed at a proximal end of the suture closure assembly.
50. The handle assembly according to any of claims 37 to 49, characterized in that it further comprises a hemostatic seal disposed within the first section of the adapter, near the sleeve drive handle, wherein the hemostatic seal includes an opening surrounding a cut portion of the sleeve shaft extending through the first section to the sleeve drive handle, the hemostatic seal being configured to seal around the cut portion of the sleeve shaft.
51. The handle assembly according to claim 50, characterized in that it further comprises a locking cap assembly disposed in the first section, around the hemostatic seal, the locking cap assembly configured to apply inward pressure on the hemostatic seal and block axial translation of the sleeve axis with respect to a remnant of the hub assembly.
52. The handle assembly according to any one of claims 37-51, characterized in that the suture closure assembly is the suture closure assembly according to any one of claims 1-19.
53. The handle assembly according to any of claims 37-52, characterized in that the thrust shaft is configured to deploy the coupling device from inside a distal end portion of the outer shaft upon reaching the native valve ring and wherein a distal end of the sleeve shaft is separated from a distal end of the outer shaft, within the outer shaft, while the coupling device is disposed within the outer shaft during navigation of the supply system to the native valve ring.
54. The handle assembly according to any of claims 37-53, characterized in that the coupling device is configured to receive and secure a prosthetic heart valve in the native valve ring.
55. A method for supplying a coupling device to a native heart valve, characterized in that it comprises: deploying the coupling device from a distal end of a delivery system, the coupling device covered by a distal section of a 237 sleeve shaft of the delivery system, the coupling device comprising a coil extending along a central axis and including a central region comprising a plurality of turns, a leading turn extending from a first end of the central region, and a stabilizing turn extending from a second opposite end of the central region, wherein a cover extends around and along an upper turn of the central region, the upper turn disposed at the second end of the central region;Place the covered coupling device on the native valve, so that the covering of the upper turn of the central region crosses and plugs a medial commissure of the native valve, at least a portion of the main turn is placed in a ventricle of the heart, and at least a portion of the stabilizing turn is placed in an atrium of the heart; and after placing the covered coupling device, retract the cuff shaft, in a proximal direction, to uncover the coupling device.
56. The method according to claim 55, characterized in that the delivery system is the delivery system according to any of claims 20-51, and wherein deploying the coupling device from the distal end of the delivery system 238 includes pushing the covered coupling device off the outer shaft of the delivery system with the thrust shaft of the delivery system.
57. The method according to claim 56, characterized in that the delivery system is the delivery system according to claim 36 and wherein retracting the sleeve shaft to uncover the coupling device includes moving the sleeve drive handle in the proximal direction.
58. The method according to any of claims 56 and 57, characterized in that it further comprises maintaining a position of the thrust shaft while retracting the sleeve shaft to uncover the coupling device and, after uncovering the coupling device, retracting the thrust shaft towards the outer shaft of the delivery system.
59. The method according to any of claims 56-58, characterized in that it further comprises, during the deployment of the covered coupling device and the placement of the covered coupling device on the native valve, flushing a plurality of lumens of the delivery system, including a first lumen disposed between the distal section of the sleeve shaft and the coupling device and a second lumen disposed between an outer shaft of the delivery system and the sleeve shaft. 239 60. The method according to claim 59, characterized in that rinsing the first lumen includes providing rinsing fluid to a thrust shaft lumen extending through the thrust shaft from a proximal end of the thrust shaft disposed within a branching section of a hub assembly, wherein a suture closure is coupled to the branching section, to a distal end of the thrust shaft, the distal end disposed near, but separate from, a proximal end of the coupling device, and flowing the rinsing fluid through the thrust shaft lumen and into and through the first lumen.
61. The method according to claim 60, characterized in that the rinsing fluid is supplied to the thrust shaft lumen through a rinsing port coupled to the branching section distal to the suture closure.
62. The method according to claim 60, characterized in that the rinsing fluid is supplied to the thrust shaft lumen through a rinsing port that is part of the suture closure and is disposed at a proximal end of the suture closure.
63. The method according to any of claims 59-62, characterized in that the rinsing of the second lumen includes supplying rinsing fluid to a first cavity formed between an outer surface of the thrust shaft and an inner surface of a conduit of the branching section, flowing the rinsing fluid from the first cavity to a second cavity formed between a thrust shaft housing and a thrust shaft main tube, and flowing the rinsing fluid from the second cavity to the second lumen.
64. The method according to any of claims 55-63, characterized in that it further comprises, during the deployment and placement of the covered coupling device, arranging a distal tip of the distal section of the sleeve shaft to extend a distance beyond, in the distal direction, a distal end of the coupling device.
65. The method according to any of claims 55-64, characterized in that it further comprises deploying a prosthetic heart valve within the central region of the coupling device.
66. A method for providing flushing fluid to a delivery system configured to supply a coupling device to a native heart valve, characterized in that it comprises: flowing flushing fluid through an internal thrust shaft lumen extending through the interior of a thrust shaft of the delivery system to a distal end 241 of the thrust shaft, wherein the thrust shaft is arranged coaxially with and at least partially within a sleeve shaft of the delivery system, the sleeve shaft and thrust shaft being arranged 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 surrounding and covering the coupling device within the outer shaft;to flow rinsing fluid from the thrust shaft lumen into a sleeve shaft lumen formed between an outer surface of the coupling device and an inner surface of the distal section of the sleeve shaft; and to flow rinsing fluid through a supply shaft lumen formed between an outer surface of the sleeve shaft and an inner surface of the outer shaft.
67. The method according to claim 66, characterized in that flowing rinse fluid through the thrust shaft lumen and into the sleeve shaft lumen and flowing the fluid through the supply shaft lumen includes continuously flowing rinse fluid from a common fluid source to the thrust shaft lumen, the sleeve shaft lumen, and the supply shaft lumen.
68. The method according to claim 242 66, characterized in that flowing rinse fluid through the thrust shaft lumen and into the sleeve shaft lumen and flowing the fluid through the supply shaft lumen includes continuously flowing rinse fluid from a first fluid source to the thrust shaft lumen and the sleeve shaft lumen and continuously flowing rinse fluid from a separate second fluid source to the supply shaft lumen.
69. The method according to any of claims 66-68, characterized in that the flushing fluid flowing through the thrust shaft lumen and into the sleeve shaft lumen and the fluid flowing through the supply shaft lumen is produced during the advancement of a distal end portion of the supply system, including the coupling device disposed therein, to the native valve and placing the coupling device, while covered by the sleeve shaft, on the native valve.
70. The method according to any of claims 66-69, characterized in that the flow of rinsing fluid through the thrust shaft lumen and into the sleeve shaft lumen and the flow of fluid through the supply shaft lumen occurs during the preparation of the delivery device for an implantation procedure, prior to inserting the delivery device 243 into a patient.
71. The method according to any of claims 66-70, characterized in that flowing the rinse fluid through the supply shaft lumen includes flowing rinse fluid from a first rinse port coupled to a conduit of a supply system hub assembly to a first cavity formed between an outer surface of the thrust shaft and an inner surface of the conduit, flowing rinse fluid from the first cavity to a second cavity disposed between an inner surface of a thrust shaft housing and an outer surface of a thrust shaft main tube, and flowing rinse fluid from the second cavity to the supply shaft lumen.
72. The method according to claim 71, characterized in that making the rinse fluid flow through the lumen of the supply shaft includes making rinse fluid flow from a first rinse port coupled to the conduit and in direct fluid communication with the first cavity, into the first cavity.
73. The method according to claim 72, characterized in that making the rinse fluid flow through the thrust shaft lumen and into the sleeve shaft lumen includes making the rinse fluid flow from a second rinse port coupled to the conduit, near where the first rinse port is coupled to the conduit, and in direct fluid communication with the thrust shaft lumen, into the interior of the thrust shaft lumen.
74. The method according to claim 73, characterized in that it further comprises keeping the rinse fluid flow from the first rinse port to the first cavity separate from the rinse fluid flow from the second rinse port to the thrust shaft lumen.
75. A coupling device for coupling a prosthetic valve to a native heart valve, characterized in that it comprises: a coil extending along a central axis, including a main turn, a central region, and a stabilizing turn, wherein: the central region has a plurality of turns having substantially equal inner diameters, the main turn extends from one end of the central region and has a diameter greater than the diameter of the central region, and the stabilizing turn has a diameter greater than the diameter of the central region and extends from the opposite end of the central region from the front turn.
76. The coupling device according to claim 75, characterized in that the stabilizing loop is designed to create three contact points 245 in a native anatomy.
77. The coupling device according to any of claims 75-76, characterized in that the stabilizing loop is designed to sit lower in the clearance than the central region, thereby raising the central region.
78. The coupling device according to claim 75, characterized in that the stabilizing loop has a diameter larger than an opening of a native mitral valve but sufficiently smaller to rest on the mitral plane.
79. The coupling device according to claim 75, characterized in that the stabilizing loop is configured to create a ring around an deployed prosthetic valve.
80. The coupling device according to any of claims 75-79, characterized in that the central region has at least three complete turns.
81. The coupling device according to any of claims 75 to 80, characterized in that the stabilizing loop has a cover to form a seal against a prosthetic valve.
82. The coupling device according to any of claims 75 to 80, characterized in that an upper turn of the central region, the upper turn 246 disposed at the end of the central region from which the stabilizing turn extends, includes a cover.
83. The coupling device according to claim 81 or 82, characterized in that the cover is a foam.
84. The coupling device according to claim 83, characterized in that the foam is selected from the group consisting of: poly(ethylene) terephthalate, polyurethane, and polyurethane-polycarbonate matrix.
85. The coupling device according to claim 81 or 82, characterized in that the cover is a braided structure.
86. The coupling device according to claim 85, characterized in that the braided structure is a shape memory material selected from the group consisting of: shape memory alloy, shape memory metal, and nitinol.
87. The coupling device according to any of claims 81-86, characterized in that the cover has pores sized to be atraumatic to native tissues and to allow tissue growth into the interior of the cover.
88. The coupling device according to any one of claims 75 to 87, characterized in that it further comprises a soft cover along the entire length of the coil to reduce friction and maintain retention forces for a prosthetic valve.
89. The coupling device according to claim 88, characterized in that the soft cover comprises a plurality of ePTFE layers bonded together.
90. The coupling device according to claim 89, characterized in that the union is intermittent to increase the rubberiness of the soft cover.
91. The coupling device according to any of claims 75-79 and 81-90, characterized in that the central region 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 main turn, and wherein the central region forms a generally hourglass-shaped structure, wherein the distal turn and the proximal turn have a larger diameter than the at least one intermediate turn.
92. The coupling device according to any of claims 1-90, characterized in that the central region 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 main turn, and wherein the central region forms a generally barrel-shaped structure, wherein the at least one intermediate turn has a larger diameter than the distal turn and the proximal turn.
93. The coupling device according to any of claims 1-92, characterized in that it includes a flange created by joining the stabilizing turn to the next adjacent turn in the central region using a fabric.
94. The coupling device according to any of claims 1-93, characterized in that the coil incorporates a radiopaque marker.
95. The coupling device according to claim 94, characterized in that the radiopaque marker is located a quarter turn around the entry turn.
96. An implantable cardiac valve prosthesis, characterized in that it comprises: an annular frame comprising an inflow end and an outflow end and being radially foldable and expandable between a radially collapsed configuration and a radially expanded configuration, wherein the frame defines an axial direction extending from the inflow end to the outflow end; 249 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 it.
97. The implantable prosthetic heart valve according to claim 96, characterized in that the flange is constructed of a memory material.
98. The implantable prosthetic heart valve according to any of claims 96-97, characterized in that the flange is made of nitinol.
99. The implantable prosthetic heart valve according to any of claims 96-98, characterized in that the flange is attached to the annular frame with an intermediate fabric.
100. The implantable prosthetic heart valve according to any of claims 96 to 99, characterized in that it further comprises a skirt attached to an outer surface of the annular frame.
101. The implantable prosthetic heart valve according to claim 100, characterized in that the skirt is constructed of at least one foam and fabric.
102. The implantable prosthetic heart valve according to claim 101, characterized in that the foam is selected from at least one of the group consisting of 250 polyethylene terephthalate, polyurethane and polyurethane-polycarbonate matrix.
103. The implantable prosthetic heart valve according to any of claims 100-102, characterized in that the skirt is expandable.
104. The implantable prosthetic heart valve according to any of claims 100-102, characterized in that the skirt comprises both fabric and foam.
105. The implantable prosthetic heart valve according to any of claims 100, 101 and 103, characterized in that the skirt is formed of fabric having a plurality of floats.
106. The implantable prosthetic heart valve according to claim 105, characterized in that the plurality of floats are separated by a plurality of bands.
107. The implantable prosthetic heart valve according to claim 106, characterized in that the plurality of flanges are formed as a gauze fabric.
108. The implantable prosthetic heart valve according to any of claims 100-107, characterized in that the annular frame includes a memory material incorporated or applied beneath the skirt to assist in skirt expansion. 251 109. The implantable prosthetic heart valve according to any of claims 100-108, characterized in that the skirt has a larger diameter near the inlet flow end of the prosthetic valve than near the outlet flow end of the prosthetic valve.
110. The implantable prosthetic heart valve according to any of claims 100 to 109, characterized in that the skirt has a pocket for the placement of an embolic material.
111. The implantable prosthetic heart valve according to claim 110, characterized in that the pocket has a pore to allow the insertion of the embolic material.
112. The implantable prosthetic heart valve according to any of claims 110-111, characterized in that the pocket has a permeable or semi-permeable cover to allow fluid exchange between the embolic material and the native blood.
113. The implantable prosthetic heart valve according to any of claims 110-112, characterized in that the embolic material is selected from a hydrogel, an ethylene vinyl alcohol dissolved in dimethyl sulfoxide, and an n-butyl cyanoacrylate.
114. A system for implanting a coupling device in a native valve, characterized in that it comprises: a supply catheter; the coupling device according to any of claims 75 to 95, wherein the coupling device has an end portion at the end of the stabilizing loop located opposite the central region; a push shaft disposed in the supply catheter and including a distal end disposed near the end portion of the coupling device; and a sleeve shaft located coaxially with the push shaft and disposed between the supply catheter and the push shaft; wherein the system is configured such that the push shaft and the sleeve shaft operate in parallel.
115. The system according to claim 114, characterized in that the sleeve shaft comprises a distal section, a middle section, and a proximal section, wherein the distal section forms a lubricating sleeve that covers the coupling device, and the proximal section is used to activate the position of the lubricating sleeve.
116. The system according to claim 115, characterized in that the lubricating sleeve is a low friction material.
117. The system in accordance with any of the 253 claims 114-116, characterized in that the lubricating sleeve has a hydrophilic coating.
118. The system in accordance with any of claims 115-117, characterized in that the lubricating sleeve has a hydrogel coating.
119. The system in accordance with any of claims 115-118, characterized in that the proximal section is rigid and has a cut portion to allow access to the thrust shaft.
120. The system in accordance with any of claims 115-119, characterized in that the distal section and the middle section are flexible and each is constructed of a polymer and a braided structure.
121. The system according to claim 120, characterized in that the polymer is a polyether-amide block copolymer or a mixture of two or more polyether-amide block copolymers.
122. The system in accordance with any of claims 120-121, characterized in that the braid is made of stainless steel.
123. The system in accordance with any of claims 119-122, characterized in that the distal section has a high-density braid.
124. The system in accordance with any of claims 119-123, characterized in that the middle section 254 has a braid of lower density than the distal section.
125. The system according to any of claims 114 to 124, characterized in that the push shaft comprises: a main hypotube having a distal end disposed near the coupling device and a proximal end opposite the distal end; a housing; a plug; and a proximal extension; wherein the housing runs coaxially to the main hypotube and the cuff shaft, is welded to the proximal end of the main hypotube using the plug, and is disposed between the catheter and the cuff shaft; and wherein the proximal extension extends from the proximal end of the main hypotube.
126. The system according to claim 125, characterized in that the proximal extension is constructed of a flexible material.
127. The system according to any of claims 125-126, characterized in that the housing and the plug are welded to the main hypotube and wherein the cut portion of the sleeve shaft is arranged and configured to slide within a cavity formed between the main hypotube and the housing. 255 128. The system in accordance with any of claims 114 to 127, characterized in that it further comprises a handle assembly.
129. The system according to claim 128, characterized in that the handle assembly comprises a general Y-shaped connector.
130. The system according to claim 129, characterized in that the Y-shaped connector has a straight section and a branch, wherein the sleeve axis extends to the end of the straight section and the proximal extension extends to the end of the branch.
131. The system in accordance with any of claims 128 to 130, characterized in that the handle assembly further comprises a rinsing port.
132. The system according to claim 131, characterized in that the flushing port is configured in such a way that a plurality of lumens formed between the catheter, the cuff shaft, and the push shaft are simultaneously dischargeable from a single port.
133. The system according to any of claims 130-132, characterized in that the handle assembly includes a hemostatic seal located in the formed straight section and having a first end located near an opening in the shape of the sleeve shaft.
134. The system according to claim 256 133, characterized in that the sleeve shaft has a laser-cut portion forming an overall U-shaped structure, and the opening has a U-shape.
135. The system in accordance with any of claims 133-134, characterized in that the handle assembly further includes a first rigid washer located at one end of the hemostatic seal and a second rigid washer at the second end of the hemostatic seal.
136. The system according to claim 135, characterized in that the first and second rigid washers exert inward pressure on the hemostatic seal to form a seal between the hemostatic seal and the sleeve shaft.
137. The system in accordance with any of claims 135-136, characterized in that the handle assembly further comprises a closing cap assembly.
138. The system according to claim 137, characterized in that the closing cap assembly allows the inward pressure adjustment between the first and second rigid washers and the hemostatic seal to immobilize the sleeve shaft.
139. The system in accordance with any of claims 114-138, characterized in that it further comprises a suture closure attached to the handle assembly.
140. The system in accordance with any of the 257 claims 139, characterized in that the suture closure is a ratchet suture closure.
141. The system according to claim 140, characterized in that the ratchet suture closure comprises a rotator for adjusting the tension on a suture.
142. The system according to claim 141, characterized in that the suture closure further comprises a directional selector.
143. The system according to claim 142, characterized in that the ratchet mechanism comprises a gear with teeth attached to the rotator and a ratchet with teeth attached to the directional selector, and a spring plunger, wherein the spring plunger holds the ratchet in a selected direction, and wherein the teeth of the ratchet interact with the teeth of the gear to allow unidirectional rotation of the gear.
144. The system according to claim 141, characterized in that the ratchet mechanism comprises a central screw with a friction control nut and at least one friction pad, wherein the rotator is attached to the central screw, the friction control nut is attached to the distal central screw of the rotator, and the at least one friction pad is inserted into the central screw, wherein turning the rotator too far in one direction increases friction on the central screw, so as to prevent further rotation of the rotator.
145. The system according to claim 141, characterized in that the ratchet mechanism comprises a spring plunger and a gear comprising a plurality of retainers, wherein the spring plunger transfers torque from the rotator and rests on a retainer of the gear, wherein rotation of the rotator beyond a certain point causes the spring plunger to retract and prevents further rotation of the rotator.
146. A method for placing an implant in a native heart valve, wherein the implant comprises the coupling device according to any of claims 75-95, characterized in that it comprises: placing the coupling device in the native heart valve, such that at least a portion of the inlet loop of the coupling device is placed in a ventricle of the heart and around one or more valve leaflets of the native valve.
147. The method according to claim 146, characterized in that: the implant further comprises the implantable prosthetic heart valve according to any of claims 96-113; and the method further comprises: placing the implantable prosthetic heart valve in the radially collapsed configuration within the coupling device; and expanding the implantable prosthetic heart valve from the radially collapsed configuration to the radially expanded configuration, such that the frame of the implantable prosthetic heart valve applies radially outward pressure on at least a portion of the central region of the coupling device.
148. The method according to any of claims 146-147, characterized in that the placement of the coupling device is carried out using the system according to any of claims 114-145, wherein the step of placing the coupling device comprises pushing the coupling device out of the catheter with the push shaft.
149. The method according to claim 148, characterized in that the step of placing the coupling device further comprises retracting the sleeve shaft after pushing the coupling device out of the catheter with the push shaft.
150. The method according to claim 149, characterized in that: the implant comprises the coupling device according to any of claims 83-87; and the step of placing the coupling device WUUa / 2U21 / Ul 4200 260 further comprises: reinserting the sleeve shaft to push the cover into an expanded shape; and retracting the sleeve shaft.
151. The method according to claim 150, characterized in that: the cover is placed on an upper turn of the central region, the upper turn being disposed at the end of the central region from which the stabilizing turn extends; and the step of placing the coupling device further comprises: placing the coupling device so that the cover extends from a first radial angular location in the left ventricle, through the PC and into the left atrium, and to a second radial angular location in the left atrium.
152. The method according to claim 151, characterized in that the first radial angular location is at a point representing a percentage of the circumferential distance from the PC to the AC of approximately 10%, approximately 20%, approximately 30%, approximately 40%, approximately 50%, approximately 60%, approximately 70%, approximately 80%, approximately 90%, or approximately 100%. 261 153. The method according to any of claims 151-152, characterized in that the second radial angular location is at a point representing a percentage of the circumferential distance from PC to AC of approximately 10%, approximately 20%, approximately 30%, approximately 40%, approximately 50%, approximately 60%, approximately 70%, approximately 80%, approximately 90% or approximately 100%.
154. The method according to any of claims 151-153, characterized in that the first radial angular location is below region A2 of the AL.
155. The method according to any of claims 151-154, characterized in that the first radial angular location is around the AC.
156. The method in accordance with any of claims 151-155, characterized in that the second radial angular location is around the AC.
157. The method according to any of claims 151-155, characterized in that the second radial angular location is approximately in the middle of P2 approximately at the point intersected by the minor axis of the mitral valve ring.