Docking station for a heart valve prosthesis

Abstract

An anchoring device can be positioned within a native valve, such as a native mitral valve, to secure a replacement prosthetic valve in place. The anchoring device can include a docking station formed from a resilient tubular member defining a generally coiled shape. The docking station can have an atrial turn or stabilizing turn, a leading turn or encircling turn, and a central region. In embodiments, the docking device has a plurality of cuts on opposite sides of the tubular member to allow for biasing of the member.

Description

[0001] Cross-references to related applications

[0002] This application claims priority to U.S. Provisional Patent Application No. 63 / 055,809, filed July 23, 2020, the disclosure of which is incorporated herein by reference in its entirety. Technical Field

[0003] This invention relates to anchoring valve prostheses. More specifically, this invention relates to a reduced-turn docking device for anchoring valve prostheses. Background Technology

[0004] Heart valve regurgitation can occur when the heart leaflets do not close completely during heart contraction. For example, mitral regurgitation occurs when blood flows back from the left ventricle through the mitral valve and into the left atrium during ventricular contraction.

[0005] In some cases, regurgitation occurs due to disease of the valvular leaflets (e.g., primary or “organic” regurgitation). Regurgitation can also be caused by dilation of the left ventricle, which can lead to secondary dilation of the mitral valve annulus. Dilation of the annulus causes the mitral valve leaflets to separate and produce poor cooptation and secondary leakage, or so-called “functional regurgitation.”

[0006] Primary regurgitation can be corrected by attempting to reshape the natural leaflets (e.g., using clips, sutures, hooks, etc.) to allow them to close completely during heart contractions. When the disease progresses too far, the entire valve may need to be replaced with a prosthesis, such as a mechanical or biological one. Building on the success of catheter-based aortic valve replacement, having the option to non-invasively replace the mitral valve using a similar type of replacement valve would be beneficial.

[0007] However, unlike the aortic valve, the mitral valve annulus does not provide a good landmark for positioning the replacement mitral valve. In the presence of calcium-related degenerative diseases, the volume of the aortic valve annulus is usually increased, making it easier to properly anchor the replacement aortic valve due to the reduced cross-sectional area of ​​the aortic valve annulus. However, in mitral valves experiencing regurgitation, the mitral valve annulus is usually thinner rather than thicker, and wider rather than narrower. The thinner and wider mitral valve annulus makes proper placement of the replacement mitral valve within the natural mitral valve annulus relatively more difficult. Furthermore, the aortic valve annulus is anatomically prominent, providing a larger "bulge" to which the replacement aortic valve can be anchored, while the smoother transition from the left atrium to the left ventricle defined by the mitral valve annulus makes proper anchoring of the replacement mitral valve more challenging.

[0008] Furthermore, the larger mitral valve annulus makes it difficult to securely implant currently percutaneously delivered valves into the natural mitral valve location. The amount of radial expansion that current replacement valves, typically designed for aortic valve replacement, can withstand during deployment and implantation is limited. Due to the differences in anatomy between the natural aortic and mitral valves, the collapsed delivery profile of aortic valve replacement would require an enlarged profile to deploy the replacement valve within the mitral valve annulus. However, this would make endovascular delivery more dangerous for the patient and more difficult to navigate the vascular system with larger diameter delivery systems. Additionally, self-expanding stents that anchor the valve to the annulus may be infeasible for mitral valve repair due to the potential for obstruction of the left ventricular outflow tract by the adjacent aortic valve.

[0009] Despite progress in mitral valve replacement, there remains a need for novel, effective, and safe anchoring devices that can be positioned near or within the native mitral valve and are suitable for securing the replacement valve in place. Past attempts at anchoring devices have included systems that provide a structure above the mitral valve plane to prevent slippage or other downward migration into the ventricles. Other attempts utilize coils with multiple turns to surround the native valvular anatomy (e.g., leaflets, chordae tendineae, etc.) and hold the device in place through friction and / or radially inward pressure on the native anatomy. Summary of the Invention

[0010] This summary 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 features included in the examples herein unless those features are expressly recited by the claim. Various features and steps described elsewhere in this disclosure may be included in the examples summarized herein, and the features and steps described herein and elsewhere may be combined in various ways.

[0011] In one embodiment, the docking device for docking a prosthetic valve to a natural heart valve includes a coil constructed of a thiopancreatic tube and extending along a central axis. The coil includes a lead turn, a central region, and a stabilizing turn, wherein the central region has about one turn, the lead turn extends from one end of the central region and has a diameter larger than the diameter of the central region, and the stabilizing turn has a diameter larger than the diameter of the central region and extends from the end of the central region opposite to the lead turn.

[0012] In a further embodiment, the hyaluronic acid tube includes multiple cutouts to allow for the biasing of the hyaluronic acid tube.

[0013] In another embodiment, at least one of the width and depth of the cut on one side of the hyaluronic acid tube allows for the biasing of the hyaluronic acid tube.

[0014] In a further embodiment, at least one of the width and depth of the cut on one side of the hyaluronic acid tube varies along the length of the hyaluronic acid tube, thereby allowing the hyaluronic acid tube to be biased along its length.

[0015] In another embodiment, the pitch between the cuts is varied to allow the offset of the hysteresis tube.

[0016] In a further embodiment, the pitch varies between 1.5 mm and 2.33 mm.

[0017] In another embodiment, the stabilizing turn has a pitch of approximately 2.33 mm.

[0018] In a further embodiment, the central region has a pitch of approximately 1.5 mm.

[0019] In yet another embodiment, the central region has a pitch of approximately 2.0 mm.

[0020] In yet another embodiment, the circumferential turn has a pitch between about 1.5 mm and about 1.92 mm.

[0021] In yet another embodiment, the surrounding turn includes a proximal segment and a distal segment, wherein the proximal segment has a pitch of about 1.5 mm and the distal segment has a pitch of about 1.92 mm.

[0022] In a further embodiment, the coil also includes a transition zone between the central region and the stabilizing turn.

[0023] In yet another embodiment, at least one of the pitch and depth of the cut varies along the length of the transition zone.

[0024] In a further embodiment, the coil also includes a transition region between the central region and the surrounding turns.

[0025] In yet another embodiment, at least one of the pitch and depth of the cut varies along the length of the transition zone.

[0026] In yet another embodiment, the docking device further includes a non-invasive covering disposed on the coil.

[0027] In yet another embodiment, the non-invasive covering is constructed of PET or ePTFE.

[0028] In a further embodiment, the coil is constructed of nitinol.

[0029] In yet another embodiment, the docking device further includes an actuation wire connected to the distal end of the lead turn and running inside the submersible tube.

[0030] In a further embodiment, the docking device also includes an interlocking disconnection device connected to the proximal end of the docking device.

[0031] In yet another embodiment, the docking device further includes a pawl disposed on the inner surface of the hyaluronic acid tube and teeth disposed on the actuating wire, wherein the actuating wire moves beyond a certain point causing the pawl to engage with the teeth.

[0032] In a further embodiment, the system for delivering a docking device to a natural valve includes a delivery catheter; a docking device as described herein, having an end portion located at one end of the stabilizing turn opposite the central region; a actuator shaft disposed in the delivery catheter and coupled to the end portion of the docking device; and an actuation wire connected to the distal end of the docking device and traveling coaxially with the actuator shaft, wherein the system is configured such that the actuator shaft and the actuation wire are configured to operate in parallel.

[0033] In yet another embodiment, the system further includes an actuation assembly, wherein the actuator shaft and the actuation wire are controlled via a control assembly.

[0034] In a further embodiment, the actuation assembly includes a generally Y-shaped connector.

[0035] In yet another embodiment, the generally Y-shaped connector includes a straight section and a branch, wherein the actuation wire extends to one end of the straight section.

[0036] In a further embodiment, the system also includes an actuation handle connected to the actuation wire, wherein manipulation of the actuation handle controls the bias of the docking device.

[0037] In yet another embodiment, the system further includes an interlocking disconnect device disposed between the pusher shaft and the docking device.

[0038] In yet another embodiment, the interlock disconnect device includes a pusher component and a dock component, each including a connecting portion and an interlocking portion, wherein the interlocking portion of the pusher component is interleaved with the interlocking portion of the wire component.

[0039] In yet another embodiment, the interlock disconnect device forms a central hole through which the actuation wire passes.

[0040] In yet another embodiment, the system further includes a locking mechanism for locking the actuation wire into place.

[0041] In yet another embodiment, the docking component is attached to the docking device and the pusher component is attached to the pusher shaft.

[0042] In another further embodiment, the system also includes a linear rack including teeth attached to the actuation wire and pawls attached to the inner surface of the docking device, wherein the linear rack and pawls are configured to interact when the actuation wire is manipulated beyond a certain point.

[0043] In yet another further embodiment, the method of delivering the docking device includes advancing a delivery catheter into the natural valve and advancing the docking device disposed within the delivery catheter through the valve commissure and around the valve leaflet.

[0044] In yet another further embodiment, the method further includes actuating an actuation wire disposed within the docking device to manipulate the docking device around the valve leaflet.

[0045] In yet another further embodiment, the method further includes actuating the actuating wire to achieve the desired geometry of the docking device.

[0046] In another further embodiment, the method further includes actuating the actuating wire to a point that locks the actuating wire in place.

[0047] In yet another further embodiment, the method also includes cutting the actuation wire.

[0048] In various implementations, the method can be performed on a live animal or on a non-living corpse, a corpse heart, a simulator (e.g., a simulated body part, tissue, etc.), anthropomorphic images, etc.

[0049] The foregoing and other objects, features and advantages of the disclosed technology will become more apparent from the following detailed description with reference to the accompanying drawings. Attached Figure Description

[0050] The specification and claims will be more fully understood with reference to the following figures and data diagrams, which are presented as exemplary embodiments of the invention and should not be construed as a complete description of the scope of the invention.

[0051] Figure 1A perspective view is shown of an exemplary embodiment of a docking device or a core of a docking device having a reduced number of functional turns according to an embodiment of the present invention.

[0052] Figures 2A-2D An example segment of a docking device capable of being manipulated and / or controlled according to an embodiment of the present invention is shown.

[0053] Figures 2E-2G An example of a docking device having a cut segment that allows manipulation and / or control of the docking mechanism is shown according to an embodiment of the present invention.

[0054] Figure 3 Exemplary embodiments of a handle assembly for a delivery system according to various implementations are shown.

[0055] Figures 4A-4B A perspective view of the components of an example interlocking disconnect device according to various embodiments is shown.

[0056] Figure 4C A perspective view of an example interlocking disconnect device according to various embodiments is shown.

[0057] Figures 5A-5B A ratchet system for locking the actuation wire is shown according to various embodiments.

[0058] Figure 6A The actuator shaft and docking device interface are shown according to various embodiments.

[0059] Figures 6B-6D An exemplary cross-section of the detachment section of the actuation wire according to various embodiments is shown. Detailed Implementation

[0060] This document discloses various embodiments of systems, devices, methods, etc., including anchoring or docking devices that can be used in conjunction with expandable prosthetic valves (e.g., transcatheter heart valves (THVs)) at the natural valve annulus (e.g., mitral or tricuspid valve annulus) to more securely implant and retain the prosthetic valve at the implantation site. Anchoring / docking devices according to various embodiments provide or form a more circular and / or more stable anchoring site, landing zone, or implantation zone at the implantation site—in which the prosthetic valve can be expanded or otherwise implanted. Many of these docking devices and corresponding prosthetic valves have a circular valve frame or support that can be expanded or otherwise implanted into locations with a naturally circular cross-section. However, other embodiments of the docking devices have geometries more suited to natural valves with non-circular and / or non-cylindrical anatomy (e.g., elliptical, oval, longitudinally curved, etc.). In addition to providing an anchoring site for the prosthetic valve, the size and shape of the anchoring / docking device can be configured to radially tighten or pull the anatomy of the natural valve (e.g., mitral, tricuspid, etc.). In this way, one of the main causes of valvular regurgitation (e.g., functional mitral regurgitation), specifically the enlargement of the heart (e.g., left ventricular, etc.) and / or the enlargement of the valve annulus, and consequently protrusion from the annulus of the natural valve (e.g., mitral, etc.), can be at least partially compensated for or offset. Some embodiments of the anchoring or docking device also include features, for example, shaped and / or modified to better maintain the position or shape of the docking device during and / or after the prosthetic valve expands within it. By providing such an anchoring or docking device, the replacement valve can be more securely implanted and held at various valve annulus locations, including at the mitral valve annulus which does not have a natural circular cross-section.

[0061] Go to Figure 1 This figure provides a representative implementation of the docking device 100. Figure 1The core of the docking device refers to the core of the device, which may include a cover or other additions on the core to form the docking device. It is possible that some docking devices located in the atrioventricular position may migrate further or deeper into the ventricle after deployment than desired. Advantageously, avoiding excessive "dock drop" helps prevent paravalvular leakage; for example, sealing the docking device and the prosthetic valve seal higher on the natural leaflet can help prevent paravalvular leakage—which could occur if it drops any lower onto the chordae tendineae. Additionally, (e.g., by avoiding dock drop) higher placement can contribute to the long-term stability of the valve because the leaflets are thicker and stronger near the annulus—rather than near their distal ends—so anchoring at or near the annulus is expected to be stronger and provide greater long-term stability. Furthermore, placing the prosthetic valve higher can help avoid abrasion of the natural tissue (e.g., natural leaflets and / or chordae tendineae) by reducing the likelihood of the artificial valve rubbing against the leaflets and / or chordae tendineae.

[0062] Paravalvular leakage can occur for a variety of reasons, including a natural annulus that is too large compared to the prosthetic valve; a short and / or damaged commissural leaflet; incomplete capture of the natural leaflet by the docking device; a small gap (e.g., in the commissure) due to the docking device crossing from one side of the valve to the other; excessive misalignment of the prosthetic valve toward the lateral, anterior, posterior, and / or medial side of the natural valve; and / or anatomical abnormalities in certain patients (e.g., clefts, clefts associated with degenerative mitral regurgitation, etc.). Various embodiments of this disclosure are designed to compensate for, avoid, reduce, and / or eliminate several of these problems, including by holding the docking device up on both sides of the natural mitral valve (thereby reducing and / or inhibiting docking device descent by keeping the docking device and the prosthetic valve close to the plane of the natural annulus), by creating a better seal around the prosthetic valve, by creating a better seal on the natural annulus, etc.

[0063] exist Figure 1 In the examples shown, multiple embodiments of the docking device 100 have a generally coiled shape extending along a central axis, having a central region 102, a stabilizing coil (also called a stabilizing turn or atrial turn) 104, and a surrounding coil (or turn) 106. The central region 102 may be continuous and may extend generally spirally, having segments of various sizes and shapes, as described in more detail below. Figure 1 The docking device 100 shown is configured to fit at the mitral valve location, but in other embodiments it may be similarly or differently shaped and / or adapted for better fit (accommodation) also at other natural valve locations (such as the tricuspid valve).

[0064] Various factors can contribute to the total retaining force between the docking device 100 and the prosthetic valve held therein. Factors contributing to the retaining force in various implementations include, for example, the inner diameter of the functional coil, frictional forces (e.g., between the coil and the prosthetic valve), and the strength of the prosthetic valve and the radial force exerted by the valve on the coil. Figure 1 In this embodiment, the docking device 100 is designed to have low-profile turns or coils in the central region 102 while maintaining holding forces on the natural anatomical structure and / or prosthetic valve. In some embodiments, the number of turns in the central region is approximately 1 turn (±0.125 turns), approximately 1.25 turns (±0.125 turns), approximately 1.5 turns (±0.125 turns), approximately 1.75 turns (±0.125 turns), approximately 2 turns (±0.125 turns), approximately 2.25 turns (±0.125 turns), approximately 2.5 turns (±0.125 turns), approximately 2.75 turns (±0.125 turns), or approximately 3 turns (±0.125 turns), or more. In embodiments with more than one turn in the central region 102, the size and / or shape of the turns can be similarly set, or variations in size and shape may be made. When the docking device 100 and the valve prosthesis are implanted into the heart, the central region 102 of the docking device 100 serves as the primary landing or holding region for retaining the expandable prosthetic valve. While many embodiments have one or about one turn, some embodiments will have more or fewer turns (or fractions of a turn), depending on factors such as the patient's anatomy, the desired vertical direct contact between the docking device 100 and the valve prosthesis (e.g., a transcatheter heart valve or THV), and / or other factors. The coiled portion or coil(s) of the central region 102 may also be referred to as a "functional coil" or "functional turn" because the nature of these coils contributes most significantly to the amount of holding force generated between the valve prosthesis, the docking device 100, and the natural mitral valve leaflet and / or other anatomical structures.

[0065] Figure 1 An embodiment is shown in which a flat stabilizing coil (or turn) 104 has a diameter larger than the diameter of the central region 102, and extends from opposite ends of the central region 102 as a surrounding (or leading) turn 106. In several embodiments, the stabilizing coil 104 is located in the plane of the natural valve (e.g., in the plane of the natural mitral valve or the plane of the natural tricuspid valve). In such embodiments, the stabilizing coil 104 is designed to be larger than the opening of the natural valve (e.g., the mitral or tricuspid valve), but not so large that the stabilizing coil 104 is not located in the plane of the natural valve. The stabilizing coil 104 can be formed in a continuous curve, such as... Figure 1As shown, it may open or be offset toward the posterior wall of the atrium, thereby utilizing a posterior shelf to prevent the docking device 100 from falling into the ventricle before an artificial or prosthetic valve is deployed therein. Additionally, in some flat embodiments, the stabilizing coil will have a smooth covering to prevent trauma to the natural anatomy in areas exhibiting relative motion (e.g., as the docking device 100 passes from the atrium through the mitral valve into the ventricle).

[0066] Other embodiments have different geometries for the stabilizing turn 102, including designs that create a plane formed by at least three contact points in the atrium. These three anchoring points or contact points are the posterior clasp of a natural valve (e.g., the mitral valve), the anterior wall of the atrium, and the lateral clasp of an atrial appendage or natural valve.

[0067] A further embodiment features a hybrid docking device design with an exemplary stabilizing coil 104, configured to improve the prevention and / or suppression of paravalvular leakage. In this embodiment of the hybrid docking device 100, the stabilizing coil 104 is designed to form a near-loop around the deployed prosthetic valve, thereby aiding in sealing the valve and preventing paravalvular leakage. In some embodiments, this sealing effect is maximized by radially offsetting the docking core from the maximum valve outer diameter plus half the cross-section of the docking device. In some embodiments, achieving the maximum outer diameter of the stabilizing coil 104 (e.g., optimal contact with the atrium) before prosthetic valve deployment also aids in docking device descent. Additionally, in some embodiments, the docking device is configured such that after prosthetic valve deployment, the stabilizing coil will be flush with the outer diameter of the implanted and expanded prosthetic valve. This hybrid design can be manufactured to prevent paravalvular leakage close to the prosthetic valve by relying on different prosthetic valve outer diameters.

[0068] Multiple embodiments include a surrounding coil 106 (or a leader coil) extending from the leader end of the central region 102 to guide or navigate the coil / loop of the central region 102 around and / or through the geometry of the chordae tendineae—and most importantly, fully around the two natural leaflets of the natural valve (e.g., the natural mitral valve, tricuspid valve, etc.). Once the distal end 108 of the surrounding coil 106 is navigated around the desired natural anatomical structure, the remaining coils of the docking device 100 can also be guided around the same feature. In some embodiments, the dimensions of the other coils can be reduced sufficiently such that the corralled anatomical feature is subjected to radially inward or slightly radially inward traction. Simultaneously, the length of the enlarged surrounding coil 106 can be kept relatively short to prevent or avoid obstruction or interference of blood flow along the ventricular outflow tract by the surrounding coil 106. For example, in one embodiment, the enlarged surrounding coil 106 extends only about half a loop or half a turn.

[0069] In several embodiments, the docking device 100 has the ability to reduce the number of turns in the central region 102 due to the construction of the core of the docking device 100. In various embodiments, the core of the docking device 100 is constructed of a tube such as a thiourea tube or another elongated and hollow component.

[0070] In another embodiment, the actuation wire 107 travels longitudinally from the distal end 108 through the tube of the docking device 100 and through the proximal opening 110. In many of these embodiments, the actuation wire is securely attached to the distal end 108. The actuation wire allows an individual to manipulate the docking device 100 and / or control its geometry during installation.

[0071] The tube according to various embodiments has an outer diameter providing overall strength and / or holding force, and an inner diameter wide enough to allow the actuation wire to pass through. In some embodiments, the inner diameter allows the actuation wire 107 to be displaced from its longitudinal direction across the central axis of the docking device 100, since a coaxial actuation wire 107 may be ineffective when manipulating the docking device 100. In some embodiments, the outer diameter of the docking device 100 is narrow enough to prevent contact with the ventricular wall. The outer diameter of the tube in some embodiments is from about 1.2 mm (e.g., ±0.5 mm) to about 4 mm (e.g., ±0.5 mm).

[0072] Materials suitable for docking devices include a core constructed of flexible and biocompatible materials. In some embodiments, the core is constructed of shape memory materials, including but not limited to shape memory alloys, shape memory metals, nitinol, stainless steel, and other materials known in the art. Multiple embodiments include a covering disposed on the core to minimize or eliminate trauma to natural anatomical structures. In some embodiments, the covering is PET, ePTFE, including woven, braided, knitted, and electrospun materials made of PET and / or ePTFE. Other embodiments employ a covering constructed of biocompatible and / or bio-implantable materials. Further embodiments employ additional non-invasive materials, including expandable gels, hydrophilic materials and / or coatings, and hydrogels.

[0073] Go to Figures 2A-2D The diagram illustrates segments of the pipe 200 according to various embodiments. In various embodiments, the pipe 200 is configured as (such as...) Figure 1 The base of the docking device core is shown. In several embodiments, the ability to be manipulated via an actuation wire is provided by a plurality of primary cuts or grooves 202 in one side of the cut tube 200 to allow the tube 200 to deflect toward the primary cuts 202. Further embodiments have a plurality of secondary cuts or grooves 203 located on one or more other sides to achieve flexibility of the tube 200. For example, as... Figures 2A-2CAs shown, the secondary incision 203 is offset from the primary incision 202 and rotated approximately 180° for positioning. However, Figure 2D The secondary cut 203 is shown to be offset from the primary cut 202 and rotated about 90°. In various embodiments, the plurality of secondary cuts 203 substantially surround the tube 200, such that each secondary cut 203 extends about 180° (e.g., 170°–175°) around the tube 200. In some embodiments, the plurality of cuts 202, 203 are made in the tube 200 by cutting into the tube 200—including by laser cutting specific cuts 202, 203 into the tube 200.

[0074] Although incisions 202 and 203 are... Figures 2A-2D While generally triangular, some embodiments of the cuts 202 and 203 include other shapes, such as bulbous or rounded apexes. Bulbous or rounded apexes can prevent mechanical stress at the cut apex, which could cause the tube or docking device to crack, split, or suffer other mechanical failures. Additionally, bulbous or rounded apexes can allow for additional movement or buckling within the tube 200 by providing extra freedom of movement within the cuts 202 and 203.

[0075] like Figures 2A-2C As shown, changing the width and / or depth of the cut on one side of tube 200 can allow for the introduction of longitudinal forces—such as by increasing the travel of the actuating wire through tube 200 (e.g., Figure 1 The tension on the actuating wire 107 then biases the tube 200 to one side. Additionally, the inclusion of the incision and actuating wire allows for the creation of deflectable or "active" ends—e.g., manipulable ends—that allow the user to navigate the docking device through natural anatomical structures (e.g., lobules, chordae tendineae, etc.) to assist in adequately circling the tissue to secure the docking device. Furthermore, various embodiments have primary incisions 202 varying in depth 204, width 206, and / or spacing (also referred to as pitch) 208 to achieve various geometries when the docking device is tightened via increased tension on the articulating wire.

[0076] In several embodiments, a single length of the tube 200 has slits varying in depth 204, width 206, and / or spacing 208 along the length of the tube 200, such that under tension, the tube can form a mating device (e.g., Figure 1 The shape of the docking device 100. For example, refer to... Figure 1The central region 102 may have a wider cut 202, thereby achieving an increased bias and thus a narrower diameter of the central region—compared to the surrounding coil 106 and / or the stabilizing coil 104. In a further embodiment, the depth and / or width of the cuts 202, 203 vary along the length of the tube 200, thereby providing transitions, such as between different sections or segments of the mating device. For example, variations in the cuts 202, 203 facilitate transitions between the stabilizing coil 104 and the central region 102, and / or between the surrounding coil 106 and the central region 102.

[0077] As described herein, incisions 202 and 203 can provide a level of flexibility to the docking device during implantation. However, the longitudinal force applied via the actuation wire can provide sufficient force to lock the docking device into the specific configuration. By locking the docking device into the specific configuration, the docking device can be held at the implantation site (e.g., held at the valve annulus and / or surrounding natural valve leaflets).

[0078] Figures 2E to 2G A longitudinal view of a docking device 250 incorporating a primary cutout 202 and a secondary cutout 203 according to various embodiments is shown. The various cutouts are illustrated as to how they can be incorporated into the tubular body of the docking device 250 to achieve the overall shape or structure of the docking device. Figure 2E A longitudinal view of the docking device 250 is shown. The docking device 250 includes a plurality of primary cuts 202 along one side to allow the docking device 250 to be offset or bent along the direction of the primary cuts 202. Additionally, secondary cuts 203 are shown at positions between each of the primary cuts 202 and offset by 90°. Figure 2E As shown, both the primary cut 202 and the secondary cut 203 have bulbous or rounded apexes 252. As described herein, the bulbous or rounded apexes 252 prevent stress from accumulating at the apex of the cut, which could lead to breakage. Additionally, such bulbous or rounded apexes 252 allow for additional buckling of the mating device 250—provided by the additional space offered by these bulbous or rounded apexes 252.

[0079] As described above, the docking device 250 may be defined by various segments or sections determined along its length—including stabilizing turns, functional turns (one or more), and surrounding turns. Figure 2EAs shown, the pitch 254 or spacing between the primary incisions 202 and the depth 256 of the primary incisions 202 vary along their length. By changing the pitch 254, various embodiments alter the diameter of each segment of the docking device 250. For example, a larger pitch of the primary incisions 202 allows for a larger diameter of the atrial turn, while a smaller pitch allows for a smaller diameter of the functional turn (or one or more). Additionally, by changing the depth 256 of the primary incisions 202, various embodiments alter the flexibility of each segment. As shown in the surrounding turn segments, the increased depth 256 of the incisions 202 achieves increased flexibility of the active endpiece, which can manipulate through natural valvular anatomy (e.g., leaflets, chordae tendineae, etc.).

[0080] In various embodiments, the pitch 254 varies between 1.5 mm and 2.5 mm (±0.25 mm) to form various diameters in the various segments of the docking device 250. In some embodiments, the circumferential ring (one or more) has a pitch 254 of about 1.5 mm to 2.0 mm (±0.25 mm), thus having a smaller diameter around the leaflet, while the stabilizing ring has a pitch of about 2.25 mm to 2.5 mm (±0.25 mm), thus having a wider diameter for maintaining stability in the atrial plane. In some embodiments, the atrial ring has a pitch of 2.33 mm. Additionally, various embodiments have circumferential rings with segments having different pitches 254, allowing for better fitting around anatomical structures and / or preventing damage to natural anatomical structures. In some such embodiments, the proximal segments have a smaller spacing compared to the distal segments. In some embodiments, the proximal segment has a pitch of approximately 1.5 mm (±0.25 mm), while the distal segment has a pitch of approximately 1.92 mm (±0.25 mm). Additionally, several embodiments include a transition zone within the docking device 250. Such a transition zone is a segment where the pitch 254 and / or depth 256 of the incision 202 changes to achieve a smooth diametrical transition between other segments (e.g., functional turns (one or more) and atrial turns, or functional turns (one or more) and circumferential turns).

[0081] The length of each segment (e.g., from the proximal end to the distal end of the segment) can be configured to optimize the region for its purpose. For example, a stabilizing ring may have a length of approximately 60-70 mm (±5 mm) to allow the docking device 250 to be properly secured or stabilized in the atrium. In some embodiments, the stabilizing ring is approximately 68.3 mm (±1.0 mm). Additionally, the functional ring region may vary depending on the number of rings within this segment of the docking device 250. For example, for a single ring, the functional ring region may be approximately 65 mm (±5 mm), for two rings, approximately 130 mm (±10 mm), or for three rings, approximately 195 mm (±1.5 mm). Furthermore, the surrounding ring segment can be any suitable distance around the natural anatomical structure. In some embodiments, the proximal segment is 12.6 mm (±2.5 mm), while the distal segment is approximately 10.0 mm (±2.5 mm). Finally, the transition zone may have any length to provide a suitable transition between other segments. In some implementations, the proximal transition zone is 24.9 mm (±5 mm), while the distal transition zone is 10.0 mm (±5 mm).

[0082] Go to Figures 2F-2G The diagram shows the flattened form of the docking device 250, in which... Figure 2G It shows Figure 2F An enlarged view of the circular portion. Specifically, the tubular body of the docking device 250 is flattened, such that the tubular body is continuous across edges A and B. For example... Figure 2F As shown, various embodiments include multiple secondary cuts surrounding the docking device 250, these secondary cuts being spaced apart by small segments of the docking device 250. Although Figures 2F-2G The illustration shows two secondary cuts 203 surrounding the docking device 250, but other embodiments include three, four, five, six, or more secondary cuts 203 surrounding the docking device 250. The secondary cuts 203 can have any size to allow for flexibility in the docking device during deployment. In some embodiments, the width of the secondary cuts 203 is approximately 0.06 mm (±0.05 mm).

[0083] Besides the pitch, the depth 256 and / or other dimensions (e.g., angle, width, etc.) of the primary notch 202 can vary to provide different diameters or flexibility to the docking device 250. Figure 2FAs shown, the rear side of the shallower primary cut 202' is separated by a larger section of the docking device 250 compared to the deeper primary cut 202". The deeper cut can provide some increased flexibility of the docking device 250. In some embodiments, the section of the docking device 250 that separates the apex of the primary cut is a better measure of the depth of the construction. In some embodiments, considering that the docking device has a tubular body with a cross-sectional outer diameter of 2.1 mm, the section separating the apex of the primary cut ranges from about 0.8 mm to 2.4 mm (±0.25 mm). However, in embodiments where the tubular body has a larger or smaller cross-sectional outer diameter, this distance can vary. In some embodiments, the cross-sectional outer diameter of the tubular body is between 1.75 mm and 2.5 mm (±0.25 mm).

[0084] Furthermore, the dimensions of the primary cut 202 vary across different embodiments, such as the base width or the width at its narrowest point 259. In some embodiments, the base width 258 varies between 0.25 mm and 0.5 mm (±0.15 mm). In some embodiments, the base width is 0.33 mm. In several embodiments, the primary cut is narrowed to approximately 0.10 mm (±0.05 mm).

[0085] Additionally, one or both of the distal end 260 (e.g., a movable end or a circumferential ring) or the proximal end 262 (e.g., attached to or closer to the docking device delivery system) include one or more holes 264 or openings to allow attachment of other features, such as sutures, coverings, actuation wires, disconnection devices, or any other additional features that can be used in conjunction with the docking device 250.

[0086] docking parts delivery system

[0087] To manipulate the actuation wire in multiple implementations, the actuation wire can be connected to an actuation handle on the docking device delivery system, allowing medical professionals to manipulate the wire during docking device delivery. Go to Figure 3 The image shows the proximal end of an exemplary docking device delivery system 300. Docking device delivery systems according to various embodiments are used to deliver docking devices (e.g., Figure 1 The docking device 100 is delivered to its appropriate location in the heart (e.g., mitral valve, tricuspid valve). Multiple embodiments of the docking device delivery system 300 have a delivery catheter for insertion and navigation into the heart. Another embodiment has a pusher shaft disposed within the catheter, the pusher shaft being coupled to the docking device (e.g., Figure 1 The proximal end of the docking device 100. In various embodiments, the actuation wire travels coaxially within the actuator shaft to allow parallel operation of the actuator shaft and the actuation wire.

[0088] Multiple embodiments of the docking component delivery system 300 include a control assembly 302 for manipulating and / or delivering the docking device. For example... Figure 3 As shown, the control assembly 302 in some embodiments includes a hub assembly. In some embodiments, the hub assembly is configured as a generally Y-shaped connector, including a straight section 304 and at least one branch 306 (but it may include more than one branch). The hub assembly or Y-shaped connector may be adapted and / or configured to allow a proximal extension of the actuator shaft to extend to one end of the branch 306. Furthermore, the branch 306 may include additional components to assist in the delivery of the docking device, including one or more flushing ports 308. It should be noted that in embodiments without the Y-shaped connector, the actuator shaft may be connected to the straight section 304, and one or more flushing ports may be located on the straight section 304. Additionally, an actuation wire extends to a wire actuation handle 310 at one end of the straight section 304. In this configuration, a medical professional operates the deployment of the docking device by manipulating the position of the control assembly 302. Manipulation and / or manipulation of the docking device can be achieved by pushing and / or pulling the wire actuation handle 310—for example, manipulation of the actuation handle manipulates the bias of the docking device. The wire actuation handle 310 and control assembly 302 can be configured to work together such that they can move simultaneously when the docking device is deployed and positioned at the natural valve (e.g., by moving the entire hub assembly and / or Y-connector forward and / or backward), but can also move independently, so that the actuator / actuator shaft can hold the docking device in place while manipulating / operating the docking device by moving the actuation handle 310 (e.g., by holding the actuation assembly 302 and / or Y-connector in place relative to the main shaft of the delivery system and / or other components of the delivery system and / or the docking device, while pulling the wire actuation handle 310 proximally to manipulate / operate the docking device). The actuation wire and actuator shaft can be coaxial along a portion, all, or most of the delivery system to facilitate this working together.

[0089] In several embodiments, pulling the actuation handle 310 up to a certain point will lock the allowable wire into place, causing the mating member to lock into its functional shape, thereby anchoring the prosthetic valve (e.g., Figure 1 In various embodiments, the locking mechanism is a ratchet system in which a section of teeth on the actuating wire interacts with a series of teeth located within the tube of the docking device or within the delivery system. In further embodiments, the locking mechanism is a cam hook or cam device system to securely hold the actuating wire in a certain position. In some embodiments, the locking mechanism is reversible, allowing the medical practitioner to unlock and continue manipulating the docking device via the actuating wire.

[0090] In several embodiments, delivery of the docking device is achieved by advancing a delivery catheter to be adjacent to the natural valve. While the docking devices described herein are applicable to various valves within the heart, specific embodiments for delivery to the mitral valve are described. In some embodiments, the delivery catheter is advanced into the right atrium and moved to the left atrium via transseptal puncture to position the delivery catheter in the left atrium, thereby positioning it adjacent to the natural mitral valve. Although various methods exist for positioning the delivery device in the right atrium, various embodiments will navigate the delivery catheter via femoral delivery, such that the delivery device is navigated through the inferior vena cava via the femoral vein before being transseptally punctured into the left atrium.

[0091] Once positioned adjacent to the mitral valve, it will actuate the assembly (e.g., Figure 3 When the actuator assembly 302 is pushed forward, the pusher shaft will advance the docking device (e.g., Figure 1 The docking device 100 passes through the natural valvular commissure (e.g., mitral commissure) and enters the ventricle. As the docking device advances, the actuating handle (e.g., ...) is pushed or pulled. Figure 3 The actuating handle 310 will control the docking device, thereby manipulating it through natural anatomical structures (e.g., lobules and chordae tendineae) via a movable end controlled by an actuating wire (as described elsewhere herein). The movable end will allow for the manipulation of the loop (e.g., Figure 1 The surrounding loop 106 avoids the ventricular wall and / or trabeculae. After navigating the docking device through natural anatomical structures, tension on the actuation wire can be increased to allow the docking device's functional loops to achieve their desired geometry, including making the functional loops (e.g., Figure 1 The functional loop 102 is maintained to the desired diameter surrounding the natural valve anatomy. In various embodiments, the actuation wire is locked to maintain tension, thereby maintaining the geometry of the docking device. Once the docking device is fully deployed, the actuation wire is disconnected or cut to allow for full deployment of the docking device and removal of the delivery catheter.

[0092] In various implementations, an interlocking disconnection system can be used to disconnect the actuating wire from the docking device. (Go to...) Figures 4A-4C The image shows an interlocking disconnection device 400 according to certain embodiments. Specifically, Figure 4A and Figure 4B The pusher component 402 and the docking component 404 of the disconnecting device 400 are shown. In various embodiments, the pusher component 402 and the docking component 404 each have a connecting portion 406 and an interlocking portion 408 or 408' connected by a support portion 410. Figure 4CAs shown, the pusher component 402 and the docking component 404 are interlocked by interleaving the interlocking portions 408, 408' with the pusher component 402 and the docking component 404. Additionally, a single central hole 412 passes through both the pusher component 402 and the wire component 404 in the assembled interlock disconnect device 400. By passing a wire, such as an actuating wire, through the interlock disconnect device 400, the interlock disconnect device 400 maintains the connection between the pusher component 402 and the docking component 404, as the wire prevents lateral movement of the pusher component 402 and the docking component 404 relative to each other. Removal of the actuating wire allows lateral movement of the pusher component 402 and / or the docking component 404, thereby allowing the pusher component 402 of the interlock connection device 400 to separate from the docking component 404.

[0093] In various embodiments, the actuator component 402 is attached to the actuator shaft of the docking component delivery system via the connecting portion 406 by means of pressing, forging, attaching, joining, welding, or other methods of securing the actuator shaft to the actuator component 402. In various embodiments, the inner diameter of the connecting portion 406 is large enough to allow the actuator shaft (through which the actuation wire passes) to fit into the inner diameter of the center hole 412.

[0094] Similarly, the connecting portion 406 of the docking component 404 is attached to the docking device (e.g., Figure 1 (Dating device 100). In some such embodiments, the interlock disconnect device 400 is attached within the inner diameter of the tube forming the docking device, while in other embodiments the tube of the docking device is attached to the inner diameter of the connecting portion 406. Various embodiments attach the docking device to the interlock disconnect device 400 via pressing, forging, attaching, joining, welding, or other methods of securing the interlock disconnect device 400 to the docking device. Additionally, some embodiments incorporate a locking mechanism, such as that described above, into the docking member 404, allowing the actuating wire to pass freely through the connecting portion 406 of the docking member 404 until the locking mechanism (e.g., a ratchet system, a cam device, etc.) reaches its complementary portion within the connecting portion 406 of the docking member 404.

[0095] Alternatively, the connecting portion 406 of the mating member 404 can be attached to the actuating wire via pressing, forging, attaching, bonding, welding, or other methods such as fixing the actuating wire into the central hole 412. Furthermore, when the mating member 404 of these alternative embodiments is not connected to the actuator shaft, the inner diameter of the connecting portion 406 only needs to be large enough to connect with the actuating wire.

[0096] As described above, the removal of the wire through the interlock disconnect device 400 allows the actuator component 402 to separate from the docking component 404. In some embodiments, the wire is removed by cutting or severing it. In some embodiments, a cutting mechanism is mounted within the interlock connection device 400 to allow the wire to be cut. In other embodiments, the actuating wire may be fitted with engineered defects that allow the actuating wire to break by twisting or turning it beyond a certain threshold. In some embodiments, the actuating wire is broken by a medical practitioner, for example, by twisting an actuating handle (e.g., Figure 3 (Actuator handle 310) to apply twisting or turning.

[0097] Go to Figures 5A-5B Exemplary locking mechanisms according to various embodiments are shown. In various embodiments, a linear rack 502 including one or more teeth 504 is attached to an actuating wire 107. Additionally, various embodiments include one or more pawls 506 attached to the inner surface 508 of a hollow member forming the body of a docking device (e.g., docking device 100). In embodiments, such as Figures 5A-5B As shown, the linear rack 502 and pawl 506 act as a ratchet system such that when the actuating wire 107 is manipulated beyond a certain point (e.g., when pulled or when increased tension is applied to the actuating wire 107), the one or more pawls 506 engage with the teeth 504 in the linear rack 502. When the pawls 506 and the linear rack 502 are engaged, the actuating wire 107 is prevented from loosening, thereby locking the position of the docking device (e.g., docking device 100).

[0098] In various embodiments, the linear rack 502 circumnavigates the actuation wire 107 (e.g., 360° around the actuation wire 107), while in some embodiments, the linear rack 502 may be attached to only a portion of the wire, wherein the geometry or specific configuration of the docking device allows the linear rack to be attached around the actuation wire 107 at 45°, 90°, 135°, 180°, 225°, 270°, or 315°. Additionally, various embodiments include only a single tooth 504 in the linear rack 502, such that the docking device remains in a single position when the locking device is engaged. However, various implementations include 2, 3, 4, 5, 6, 7, 8, 9, 10 or more teeth 504 in the linear rack 502 to allow practitioners to adjust the size or configuration of the docking device and / or as a safety feature to prevent slippage between the pawl 506 and the teeth 504, so that the pawl 506 can engage with another tooth 504 without causing a loss of the shape of the docking device or the tension held on the actuating wire 107.

[0099] Go to Figures 6A-6D Various implementations include systems or mechanisms for severing the docking device from the delivery system. Figure 6A A schematic diagram is shown showing the docking device 602 connected to the actuator shaft 604 of the docking device delivery system. In various embodiments, the docking device 602 and the actuator shaft 604 are connected by an interlocking disconnection device 606 (such as described elsewhere herein). Additionally, as mentioned above, multiple embodiments include an actuation wire 608 that travels coaxially through the docking device 602, the disconnection device 606, and the actuator shaft 604, and may include a locking mechanism, such as a ratchet system 610, to lock the docking device 602 into a specific conformation and / or position within the natural valve anatomy. In multiple embodiments, the actuation wire 608 is attached to a torsion shaft 612 that travels coaxially within the actuator shaft 604. In various embodiments, the torsion shaft 612 allows the transmission of twisting motions by a user (e.g., a physician, surgeon, or other medical professional) to the actuation wire 608. By transmitting torsional or twisting motions, multiple embodiments cut off the actuation wire 608. In various embodiments, the actuation filament 608 includes a disengagement region 614 in which the actuation filament 608 is cut by torsional or twisting stress. In some embodiments, the disengagement region 614 may be cut by linear or longitudinal stress along an axis formed by the actuation filament itself.

[0100] The engineered weak points within the decoupling zone 614 may include various cross-sectional geometries, such as those indicated by axis AA. Figures 6B-6D Various exemplary geometries of the detachment region 614 are shown. For example, Figure 6B The disengagement zone 614 shown includes a flat cross-section actuating wire vs. a full-diameter actuating wire, as indicated by dashed line 616. Additionally, Figure 6C The shown disengagement zone 614 has an actuating wire with a reduced diameter vs. a full-diameter actuating wire 616, while Figure 6D The ternary separation region 614 shown includes a channel 618 within the full-diameter actuating wire 616. It should be noted that... Figures 6B-6D Examples of possible geometries for the separation zone 614 are shown. Various embodiments incorporate other geometries to achieve the cutting of the actuation filament under various tensions, forces, or stresses. In various embodiments, the separation zone 614 can be created by various manufacturing means, such as by removing portions of the actuation filament or by naturally producing specific segments of filament with such geometries through, for example, a tighter weave within a portion, a finer filament, and / or by adjusting the twisting or weaving during the manufacture of the actuation filament.

[0101] General considerations

[0102] For the purposes of this description, certain aspects, advantages, and novel features of embodiments of this disclosure are described herein. The disclosed methods, apparatuses, and systems should not be construed as limiting in any way. Rather, this disclosure relates individually, and in various combinations and sub-combinations of each other, to all novel and non-obvious features and aspects of the various disclosed embodiments. The methods, apparatuses, and systems are not limited to any particular aspect or feature or combination thereof, and the disclosed embodiments do not require the existence of any one or more specific advantages or the resolution of any one or more specific problems.

[0103] Although some operations in the disclosed embodiments are described in a specific order for ease of presentation, it should be understood that this descriptive approach encompasses rearrangement unless the specific language described below requires a specific order. For example, in some cases, the sequentially described operations may be rearranged or performed concurrently. Furthermore, for brevity, the accompanying drawings may not show various ways in which the disclosed methods can be combined with other methods. Additionally, the description sometimes uses terms such as "provides" or "implements" to describe the disclosed methods. These terms are high-level abstract expressions of the actual operations performed. The actual operations corresponding to these terms may vary depending on the specific implementation and are readily discernible to those skilled in the art.

[0104] As used in this application and claims, unless the context clearly specifies otherwise, the singular forms “a,” “an,” and “the” include the plural forms. Additionally, the term “includes” means “comprises.” Furthermore, the terms “linked” and “associated” generally mean electrically, electromagnetically, and / or physically (e.g., mechanically or chemically) joined or connected, and in the absence of specific contrasting language, the presence of intermediate elements between the linked or associated items is not excluded.

[0105] As used herein, the term "proximal" refers to a location, orientation, or portion of the device that is closer to the user and further away from the implantation site. As used herein, the term "distal" refers to a location, orientation, or portion of the device that is further away from the user and closer to the implantation site. Thus, for example, proximal movement of the device is movement of the device toward the user, while distal movement of the device is movement of the device away from the user. Unless otherwise expressly defined, the terms "longitudinal" and "axial" refer to axes extending along the proximal and distal directions, respectively.

[0106] Given that the principles of the disclosed technology can be applied to many possible implementations, it should be understood that the illustrated embodiments are merely preferred examples and should not be considered as limiting the scope of this disclosure. Specifically, the scope of this disclosure is at least as broad as the appended claims.

Claims

1. A docking device for docking a prosthetic valve to a natural heart valve, the docking device comprising: A coil constructed from a sodium hypochlorite tube and extending along its central axis comprises a surrounding turn, a central region, and a stabilizing turn, wherein: The central region has a ring. The surrounding loop extends from one end of the central region and has a diameter around the central axis that is larger than the diameter of the central region. The stabilizing turn has a diameter around the central axis that is larger than the diameter of the central region and extends from the end of the central region opposite to the surrounding turn. The aforementioned sodium hypochlorite tube includes multiple slits to allow for biasing of the sodium hypochlorite tube, and wherein: (a) The width of the cut on one side of the sodium hypochlorite tube varies along the length of the sodium hypochlorite tube, thereby allowing the sodium hypochlorite tube to be offset along its length, and wherein the central region includes a cut wider than the surrounding turn and / or the stabilizing turn; and / or (b) The pitch between the cuts is varied to allow the bias of the hysteresis tube, and the central region includes cuts with a pitch smaller than that of the stabilizing turn.

2. The docking device according to claim 1, wherein the depth of the cut on one side of the thiopancreatic tube allows for the offset of the thiopancreatic tube.

3. The docking device according to claim 1, wherein the depth of the cut on one side of the thiopancreatic tube varies along the length of the thiopancreatic tube, thereby allowing the thiopancreatic tube to be offset along its length.

4. The docking device according to claim 1, wherein the pitch varies between 1.5 mm and 2.33 mm.

5. The docking device according to claim 4, wherein the stabilizing turn has a pitch of 2.33 mm.

6. The docking device according to claim 4 or 5, wherein the central region has a pitch of 1.5 mm.

7. The docking device according to claim 4 or 5, wherein the central region has a pitch of 2.0 mm.

8. The docking device according to claim 4 or 5, wherein the circumferential turn has a pitch between 1.5 mm and 1.92 mm.

9. The docking device according to claim 1, wherein the surrounding turn comprises a proximal segment and a distal segment, wherein the proximal segment has a pitch of 1.5 mm and the distal segment has a pitch of 1.92 mm.

10. The docking device according to claim 1, wherein the coil further includes a transition region between the central region and the stabilizing turn.

11. The docking device according to claim 10, wherein at least one of the pitch and depth of the cut varies along the length of the transition zone.

12. The docking device according to claim 1, wherein the coil further includes a transition region between the central region and the surrounding turn.

13. The docking device according to claim 12, wherein at least one of the pitch and depth of the cut varies along the length of the transition zone.

14. The docking device according to claim 1, further comprising a non-invasive covering disposed on the coil.

15. The docking device of claim 14, wherein the non-invasive covering is constructed of PET or ePTFE.

16. The docking device according to claim 1, wherein the coil is constructed of nitinol.

17. The docking device of claim 1, further comprising an actuation wire connected to the distal end of the surrounding turn and traveling inside the submersible tube.

18. The docking device according to claim 17, further comprising an interlocking disconnection device connected to the proximal end of the docking device.

19. The docking device according to claim 17, further comprising: A pawl is provided on the inner surface of the sodium thiosulfate tube; and Teeth are provided on the actuating wire; The actuating wire moves beyond a certain point, causing the pawl to engage with the tooth.

20. A system for delivering a docking device at a natural valve, the system comprising: Delivery catheter; The docking device according to any one of claims 1-7, the docking device having an end portion located at one end of the stabilizing turn opposite to the central region; A pusher shaft, which is disposed in the delivery conduit and coupled to the end of the docking device; as well as An actuating wire is connected to the distal end of the docking device and travels coaxially with the actuator shaft; The system is configured such that the actuator shaft and the actuation wire are configured to operate in parallel.

21. The system of claim 20, further comprising an actuation assembly, wherein the actuator shaft and the actuation wire are controlled via the actuation assembly.

22. The system of claim 21, wherein the actuation assembly comprises a generally Y-shaped connector.

23. The system of claim 22, wherein the generally Y-shaped connector comprises a straight section and a branch, wherein the actuation wire extends to one end of the straight section and the actuator shaft extends to one end of the branch.

24. The system according to any one of claims 20-23, further comprising an actuation handle connected to the actuation wire, wherein manipulation of the actuation handle controls the bias of the docking device.

25. The system according to any one of claims 20-23 further includes an interlocking disconnection device disposed between the pusher shaft and the docking device.

26. The system of claim 25, wherein the interlock disconnect device comprises a pusher component and a docking component, each comprising a connecting portion and an interlocking portion, wherein the interlocking portion of the pusher component interleaves with the interlocking portion of the docking component, and wherein the interlock disconnect device forms a central hole, wherein the actuating wire passes through the central hole.

27. The system of claim 25 further includes a locking mechanism for locking the actuation wire in place.

28. The system of claim 26, wherein the docking component is attached to the docking device and the pusher component is attached to the pusher shaft.

29. The system of claim 25 further includes a linear rack comprising teeth attached to the actuation wire; and a pawl attached to an inner surface of the docking device, wherein the linear rack and the pawl are configured to interact when the actuation wire is manipulated beyond a certain point.

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