Systems and mechanisms for deploying docking devices for replacement heart valves

Abstract

This application relates to systems and mechanisms for deploying docking devices for replacement heart valves. Systems and methods can be used to deliver a docking device to a native valve of a patient's heart. A distal region of a delivery catheter can be positioned in an atrium of the heart, while a distal tip can be positioned at or near the commissure of the native valve. A docking device can be positioned within the delivery catheter. A pusher of a pusher tool, such as a pusher wire or tube, can be advanced distally through the delivery catheter, where the pusher can push the docking device along the delivery catheter. The docking device can be connected to the pusher tool by a wire, such as a suture. A member of the pusher tool can be rotatable to change an amount of suture extending from the pusher tool.

Description

[0001] This application is a divisional application, based on divisional application number 202210250591.2. The original application was filed on December 15, 2017, with application number 201780086129.0, and is entitled "System and Mechanism for Deploying a Docking Device for Replacing a Heart Valve".

[0002] Related applications This application claims the benefit of U.S. Provisional Patent Application Serial No. 62 / 436,695, filed December 20, 2016, and U.S. Provisional Patent Application Serial No. 62 / 560,962, filed September 20, 2017, the entire disclosure of which is incorporated herein by reference. Technical Field

[0003] This disclosure generally relates to medical devices and procedures adapted to replace functional prosthetic heart valves and related devices, such as anchoring or docking devices, that may have malformations and / or functional abnormalities in natural valves. Background Technology

[0004] First refer to Figure 1 and 2 The mitral valve 51 controls blood flow between the left atrium 52 and the left ventricle 54 of the human heart; similarly, the tricuspid valve 53 controls blood flow between the right atrium and the right ventricle. For example, after the left atrium 52 receives oxygenated blood from the lungs via the pulmonary veins, the mitral valve 51 allows oxygenated blood to flow from the left atrium 52 into the left ventricle 54. When the left ventricle 54 contracts, the oxygenated blood held in the left ventricle 54 is delivered to the rest of the body through the aortic valve 56 and the aorta 58. Simultaneously, the mitral valve should close during ventricular contraction to prevent any blood from flowing back into the left atrium.

[0005] When the left ventricle contracts, the blood pressure within the left ventricle increases significantly, which serves to prompt the mitral valve to close. Due to the large pressure difference between the left ventricle and left atrium during this time, a significant amount of pressure is exerted on the mitral valve, potentially leading to mitral valve leaflet prolapse or eversion back into the atrium. Therefore, a series of chordae tendineae 62 connect the mitral valve leaflets to papillary muscles located on the left ventricular wall, where the chordae tendineae and papillary muscles tighten during ventricular systole to hold the leaflets in the closed position and inhibit their posterior extension towards the left atrium. This helps prevent oxygenated blood from flowing back into the left atrium. Figure 1 Heart cross-section and Figure 2 A schematic map of the mitral valve top view shows the chordae tendineae 62.

[0006] The general shape of the mitral valve and its leaflets as observed from the left atrium is as follows: Figure 2As shown. Commissures 64 are located at the end of the mitral valve 51, where the anterior leaflet 66 and posterior leaflet 68 come together. Various complications of the mitral valve can potentially cause physical problems, including fatal heart failure. One form of valvular heart disease is mitral leakage or mitral regurgitation, characterized by the abnormal leakage of blood from the left ventricle back into the left atrium through the mitral valve. This can be caused, for example, by dilation of the left ventricle and / or the mitral annulus, resulting in incomplete coaptation of the natural mitral leaflets, thus leading to leakage or regurgitation. This can also lead to problems with the natural leaflets, and / or weakening of the chordae tendineae and / or papillary muscles (or other problems), which in turn can lead to mitral regurgitation. In these cases, it may be necessary to repair the mitral valve or functionally replace it with a prosthetic heart valve.

[0007] However, limited research has been conducted on developing commercially available methods for mitral valve replacement via catheter implantation and / or other minimally invasive procedures rather than open-heart procedures. This may stem from the fact that mitral valve replacement is more challenging to address than aortic valve replacement in aortic valve replacement techniques, for example, due to the non-circular physical structure of the mitral annulus and the greater difficulty in accessing it. Given the greater advancements in transcatheter aortic valve technology, the use of similarly circular valve prostheses for mitral valve applications could be beneficial.

[0008] The main obstacle to mitral valve replacement is the effective anchoring or preservation of the valve in its mitral position, due to the large circulatory loads it bears. Particularly during ventricular systole, the motion of the heart and the loads or pressures on the valve can combine to shift or dislodge an inadequately anchored prosthesis. Furthermore, motion and rhythmic loads can easily fatigue the implant, leading to implant breakage or other damage. Even slight misalignment of the valve can negatively impact blood flow through it. Simultaneously, puncturing the tissue in or around the mitral annulus to better anchor the implanted valve can lead to accidental cardiac perforation and patient injury.

[0009] Another challenge with mitral and tricuspid valve replacement is the size and shape of the natural valve annulus. For example, a round or cylindrical replacement valve, similar to that used for aortic valve replacement, may not be suitable for the mitral valve location. A replacement valve that is too small or of the wrong shape may cause leakage around the implanted valve (i.e., paravalvular leakage) if a good seal is not established around the valve. An oversized replacement valve may protrude and damage the natural valve annulus. Furthermore, the presence of chordae tendineae and other anatomical structures can create obstacles, making it more challenging to adequately anchor the device in the mitral valve location. Moreover, significant variations in the anatomy of the mitral and / or tricuspid valves between patients make it difficult to obtain a solution effective for all or at least multiple patients. Summary of the Invention

[0010] This summary is intended to provide examples and not to limit the scope of the invention in any way. For example, unless the claims expressly recite these features, the claims do not require any features included in the examples of this summary. Moreover, the described features can be combined in various ways. Various features and steps described elsewhere in this disclosure may be included in the examples summarized herein.

[0011] One way to apply round or cylindrical transcatheter valve technology (e.g., for aortic valve replacement) to non-circular valve replacements (e.g., mitral valve replacement, tricuspid valve replacement, etc.) is to use anchors (e.g., coiled anchors, spiral anchors, mitral valve anchors, etc.) or docking stations that form or otherwise provide a more round or cylindrical docking site at the natural valve location (e.g., mitral valve location) to retain such a prosthetic valve.

[0012] The anchoring or docking device itself can be designed for delivery via a transcatheter method. One such anchoring or docking device is a coil or anchor comprising a helical region having multiple turns that define a circular or cylindrical internal space for docking a prosthesis or bioprosthesis—such as a THV. In this way, existing expandable transcatheter valves developed for the aortic location, or similar valves slightly modified to more effectively replicate the function of a natural valve (e.g., natural mitral valve function), can be more securely implanted into such a docking device / station positioned at the natural valve annulus (e.g., natural mitral valve annulus).

[0013] The docking device / station can be initially positioned at the natural valve annulus. Subsequently, the prosthesis (e.g., a valve implant or transcatheter heart valve) can be advanced and positioned via the docking device / station while in a collapsed position. It can then be expanded, for example, by self-expansion (e.g., in the case of valves constructed with NiTi or other shape memory materials), balloon dilation, or mechanical dilation, such that the frame of the prosthetic valve radially pushes against the docking device / station and / or the tissue between them to hold the valve in place.

[0014] Preferably, the docking device / station can also be delivered with minimal or less invasive procedures, for example, by the same or similar methods used for delivering prosthetic valves (e.g., transcatheter methods), so that a completely separate procedure is not required to implant the docking device / station before delivering the prosthetic valve. Such a docking device can also potentially be used with any natural heart valve, for example, at the tricuspid, pulmonary, or aortic locations, to provide a more robust prosthetic valve implantation at these sites as well.

[0015] Prior to THV delivery, these anchors or anchoring devices (e.g., coiled or spiral anchors) can be delivered to the implantation site using deployment tools to provide a more stable base or support structure into which the THV can expand or otherwise implant or abut. For example, a guide sheath and / or delivery catheter can be advanced through the patient's vascular system, positioning the distal end of the delivery catheter at or near the implantation site. The anchor or docking device can then be advanced through and / or exited from the delivery catheter and transformed and / or adjusted to the desired shape and position at the implantation site. Optionally, the shape of the distal region of the delivery catheter can also be curved, angled, or otherwise adjusted to facilitate easier or more appropriate positioning of the anchor or docking device at the implantation site. The handle of the delivery catheter can be designed to allow the practitioner or other end-user to easily control the shape and / or movement of the distal region of the delivery catheter.

[0016] An advance tool or mechanism (e.g., a pusher tool) may be part of a system for delivering an anchoring or docking device and may be used to physically push or otherwise advance the anchoring or docking device through and / or out of the delivery catheter. A pusher tool or other advance mechanism is described that provides a simple and effective way to advance the anchoring device through the delivery catheter to the implantation site. Optionally, the pusher tool may also facilitate the retraction and / or retrieval of the helical anchor into the delivery catheter, for example, to reposition or remove the anchoring / docking device.

[0017] Delivery devices and systems for delivering a coiled anchoring device to the natural valve annulus of a patient's heart may include various components, including those described in various locations herein. The anchoring device may be configured to secure a prosthetic heart valve to the natural valve annulus. Delivery devices and systems may include a delivery catheter having a longitudinal axis and a distal region configured or adjustable / convertible to be curved in a plane (e.g., in a plane intersecting the longitudinal axis).

[0018] The delivery device and system may also include a pusher tool. The pusher tool may have a pusher (e.g., including a pusher line, pusher tube, etc.) that can be connected (indirectly or directly) to the delivery catheter on a side opposite the distal region of the delivery catheter. For example, the delivery catheter may include a handle, or be attached / attached to a handle, which is connected to or can be connected to the pusher tool and / or the pusher. Optionally, the pusher tool and / or the pusher need not be directly or permanently connected to the catheter handle or delivery catheter, but may simply have a pusher or pusher line inserted through it.

[0019] The pusher tool may include a body and a pusher. The body may be configured to be rotatably fixed relative to the delivery catheter or configured such that the pusher tool and / or pusher can be fixed or locked (e.g., to a stabilizer) such that the pusher tool and / or pusher does not rotate relative to the delivery catheter. The pusher tool may include controls (e.g., knobs, buttons, tabs, inputs, etc.) connected to the body and / or pusher (e.g., pusher line or pusher tube). In one embodiment, the control is a knob rotatable relative to the body, and the pusher is connected to the knob. The pusher (e.g., pusher line or pusher tube) may be configured to extend through the body to the delivery catheter and, when the control is actuated (e.g., when the knob is rotated relative to the body), translate and / or move axially within the delivery catheter, thereby moving an anchoring device held in the delivery catheter.

[0020] A method of delivering a docking or anchoring device (e.g., a spiral or coiled anchoring device) to a patient's natural heart valve may include multiple steps, including those disclosed in various locations of this disclosure. For example, the method may include obtaining and / or providing the anchoring / docking device (e.g., a coiled or spiral anchoring device), a delivery catheter, a guide sheath, a pusher tool and / or a pusher, and / or various systems, devices, and / or other components. The anchoring device may be configured to secure a prosthetic heart valve to the natural valve.

[0021] In one embodiment, the method includes positioning a distal region of a delivery catheter in the atrium of the heart, adjusting or repositioning the delivery catheter to a first position and / or configuration—whereby the distal region of the delivery catheter is at least partially curved around a natural valve, and / or positioning the distal opening of the delivery catheter at or near the commissure of the natural valve.

[0022] A pusher or pusher line / tube is used to push all or part of the anchoring device, such as a first part (e.g., a circumferential coil and a functional coil), out of the distal opening of the delivery catheter and into the ventricle of the heart. This can be done while the delivery catheter is held in a first position. The guide sheath, delivery catheter, pusher tool / pusher can be secured or held in place proximally by locking or securing the handle / body at the proximal end to a stabilizer (e.g., a stabilizing device).

[0023] In cases where the pusher or pusher line / tube includes a pusher tool having a knob (or other control) that can move and / or control the pusher or pusher line / tube, the method includes rotating the knob of the pusher tool (or otherwise actuating the control) in a first direction to advance the pusher or pusher line / tube distally through the delivery catheter while the delivery catheter is held in a first position. As the knob is rotated (or the control is actuated) and the pusher or pusher line / tube is advanced distally, the pusher or pusher line / tube may push all or part of the anchoring device, such as a first part (e.g., a circumferential coil and a functional coil), out of the distal opening of the delivery catheter and into the ventricle. If the distal opening is located on the commissural atrial side, this may include pushing the anchoring device through the commissure of the natural valve.

[0024] When the previous step only involved using a pusher or pusher line / tube to push the first part of the catheter out of its distal end (e.g., while the delivery catheter remains positioned), the method then involves releasing the second part of the anchoring device (e.g., a stabilizing coil / turn or an atrial coil / turn) from the delivery catheter. This can be done in several ways. For example, the pusher tool, pusher, and / or pusher line / tube can be locked or secured in place (e.g., by locking or securing its proximal end as in a stabilizer, and / or by locking / holding / maintaining a knob in place) while the delivery catheter is pulled proximally or retracted. This can hold the anchoring device in place (e.g., because it is adjacent to the positioned pusher or pusher line / tube) while unsheathing it from the delivery catheter. If a guide sheath is used, the guide sheath can also be locked / secured in place as the delivery catheter is retracted (e.g., in a stabilizer).

[0025] Optionally, if the system is configured such that rotating the body of the actuator in a direction opposite to the first direction while holding the knob in position (e.g., where the body of the actuator and the delivery catheter are rotatably fixed relative to each other such that the knob holds the anchoring device in position on the natural valve, and the rotation of the body also causes the distal region of the delivery catheter to rotate) causes proximal movement of the delivery catheter, thereby releasing the second part of the anchoring device into the atrium from the distal opening of the delivery catheter.

[0026] In one embodiment, a delivery device and system for delivering an anchoring or docking device to the natural valve annulus of a patient's heart includes a delivery catheter and a pusher tool. The delivery catheter has at least one lumen (e.g., a first lumen) and may have multiple lumens, such as 2-6 lumens. The pusher tool includes a pusher or a pusher suture or tube. The pusher tool may also include a suture or thread (e.g., for attaching or retrieving sutures / threads) and / or a suture or thread lock or locking mechanism. The pusher tool may also include a rotatable member. The pusher or pusher suture or tube is slidably received within the first lumen. The pusher or pusher suture or tube has a distal portion and a proximal portion, and may have a lumen extending from the proximal portion to the distal portion (e.g., a pusher lumen or a second lumen).

[0027] The suture or thread lock or locking mechanism may have any of the parts / assemblies described in the various locations described in this disclosure. For example, the suture / thread lock or locking mechanism may be attached to the proximal portion of the pusher or pusher line or tube. The suture or line (e.g., a retrieval suture or line) may extend from the suture or thread lock or locking mechanism through a cavity (e.g., a pusher cavity / second cavity) to the docking device to connect the anchoring or docking device to the pusher tool.

[0028] The suture / thread lock or locking mechanism may include a rotatable member connected to the suture or thread (e.g., for retrieving the suture or thread). The rotatable member may be locked in place in various ways, for example, the rotatable member may have a first position (e.g., a locked or non-rotating position) that locks the amount of suture or thread (e.g., for retrieving the suture or thread) extending from the lock or locking mechanism, and may have a second position (e.g., a movable or rotatable position) that allows the amount of retrieval of the suture or thread extending from the lock or locking mechanism to be increased or decreased.

[0029] Methods of delivering an anchoring or docking device to a patient's natural heart valve may include additional steps. For example, the distal region of the delivery catheter may be positioned within the atrium of the heart. The anchoring / docking device may be positioned or located within the delivery catheter. A pusher tool (e.g., a pusher line or tube) may be advanced distally through the delivery catheter such that the pusher pushes and / or pulls the anchoring / docking device within the delivery catheter and / or pushes and / or pulls the anchoring / docking device into or out of the delivery catheter (e.g., the pusher tool may be used to push the anchoring / docking device axially or distally within the delivery catheter and / or push the anchoring / docking device out of the delivery catheter, and the pusher tool may be used to pull / retract the anchoring / docking device axially or proximally into the delivery catheter and / or pull / retract the anchoring / docking device within the delivery catheter). The docking device may be connected to the pusher tool via a connector, such as a suture or thread (e.g., optionally, using the same or similar suture / thread lock or locking mechanism as described in the various locations described in this disclosure). A component of the pusher tool (e.g., a rotatable component) can be rotated to change the amount of suture extending from the pusher tool.

[0030] By using a separate anchoring / docking device, the replacement valve can be more securely held at locations such as the mitral or tricuspid valve, providing a more stable docking site for the replacement valve. The anchoring / docking device is delivered via a delivery catheter, and a pusher tool or other pushing mechanism is used to provide easier control over the advancement, retraction, positioning, and / or repositioning of the anchoring device at the implantation site. The pusher tool may include a pusher, such as a pusher wire or pusher tube.

[0031] The actuator or actuator line / tube can be configured to extend through any delivery conduit disclosed herein. The actuator line / tube may have multiple segments, each of which may have a different stiffness. A first segment of the actuator line / tube may have a first stiffness, a second segment may have a second stiffness, and a third segment may have a third stiffness. The stiffness of the first segment may be less than that of the second segment, and the stiffness of the second segment may be less than that of the third segment. The actuator line / tube may be constructed from a hypotube, polymer tube, coil tube, coil spring, flexible tube, wire, rod, etc. One or more segments of the actuator tube (e.g., the third segment) may be constructed from an uncut hypotube. One or more segments of the actuator tube (e.g., the first, second, and / or third segment) may be constructed from a hypotube with discontinuous cuts. The frequency and / or size of the discontinuous cuts may vary along the length of the hypotube. The actuator line / tube may also include a cover (e.g., a polymer cover, a fabric cover, etc.).

[0032] In one embodiment, the pusher tool includes a distal portion and a proximal portion, a cavity extending from the proximal portion to the distal portion, and an opening at the distal portion. A thread or suture (e.g., a retrieval thread / suture) extends through the cavity to connect the pusher tool to the proximal end of a docking device. The thread / suture (e.g., a retrieval thread) may pass through a hole near the proximal end of the docking device, thereby connecting the docking device to the pusher tool. The thread / suture (e.g., a retrieval thread) may pass through the central cavity from the distal end of the pusher tool back to the proximal region of the pusher tool. The first and second ends of the retrieval thread may be connected to the proximal portion of the pusher tool. The pusher tool may further include a pusher or pusher thread / tube. The pusher or pusher thread / tube may have a distal end including a braided layer. The pusher tool may have a pusher or pusher thread / tube including a distal end with a soft layer. The pusher tool may further have a pusher or pusher thread / tube including a distal end with a rounded or curved end region.

[0033] The pusher tool may further include a suture or thread lock or locking mechanism, which may have any of the parts / assemblies described in the various locations of this disclosure. In one embodiment, the lock or locking mechanism includes a body having a first portion, a second portion extending away from a central region of the first portion, and a rotatable member connected to and rotatable relative to the first portion of the body. The lock or locking mechanism may further include a handle extending from one side of the first portion of the body at a first end of the body. The handle facilitates rotation of the rotatable member relative to the first portion of the body. The lock or locking mechanism further includes an engagement member at the second end of the body opposite the handle, wherein the engagement member connects at least one end of the thread / suture to the body. The lock or locking mechanism may further include a hole extending through the second portion of the body and connecting the first portion of the body to a distal opening of the body. The hole forms a channel from the second portion of the body to the first portion of the body, wherein the channel may allow the thread to engage the rotatable member. The thread / suture may be anchored using the engagement member. Rotating the handle can be used to adjust the amount of thread wound on the rotatable member. The lock or locking mechanism may further include a window in the second portion exposing a portion of the thread. The lock or locking mechanism may further include a sealing cap connected to a second part of the body. Attached Figure Description

[0034] Other features and advantages of the invention will become apparent from the description of the embodiments using the accompanying drawings. In the drawings: Figure 1 A schematic cross-sectional view of the human heart is shown; Figure 2 A schematic top view of the mitral valve annulus of the heart is shown; Figure 3 A perspective view of an exemplary spiral anchoring or docking device is shown; Figures 4A to 4D A partial perspective view is shown of an exemplary method for implanting an anchoring or docking device at a natural valve of the heart using a transseptal technique; Figure 5 A cross-sectional view of an exemplary anchoring or docking device positioned at the natural valve of the heart prior to delivery of a prosthetic heart valve is shown. Figure 6 Cross-sectional views of the anchoring or docking device and the prosthetic heart valve that are ultimately implanted at the natural valve of the heart are shown. Figure 7 A perspective view of the distal portion of an exemplary delivery catheter that can be used to implant an anchoring or docking device at a natural valve is shown. Figure 8 A perspective view of an exemplary catheter handle for use in controlling a delivery catheter or a portion thereof is shown; Figure 9 A perspective view of an exemplary pusher tool is shown, wherein the pusher tool can be used to advance an anchoring or docking device through and / or out of a delivery conduit; Figure 10 It shows Figure 9 A 3D view and a partial cross-sectional view of the actuator tool; Figure 11 It shows Figure 9 and Figure 10 An enlarged partial cross-sectional view of a section of the pusher tool, including portions of the pusher line and channels for advancing and retracting the pusher line relative to the rest of the pusher tool; Figure 12 It shows Figure 9 and 10 An enlarged view of another section of the pusher tool, including a portion of the exemplary pusher line and a slot for holding the pusher line; Figure 13 A schematic diagram of an exemplary actuator tube is shown; Figure 14 A partial cross-sectional view of the distal end of the actuator tube / line connected to the proximal end of the anchoring or docking device is shown; Figure 15 A partial perspective cross-sectional view of an exemplary pull line or suture / thread lock or locking mechanism for a pusher tool is shown; Figure 16A and 16B The first step of an exemplary method for delivering an anchoring or docking device using an exemplary pusher tool is shown; Figure 17A and 17B The second step of an exemplary method for delivering an anchoring or docking device using a pusher tool is shown; Figure 18A schematic representation of an exemplary system for delivering anchoring or docking devices is shown, illustrating that the anchoring or docking devices are within a delivery conduit and engage a pusher or pusher line or tube; Figure 19 A schematic representation of an exemplary system for delivering anchoring or docking devices is shown, illustrating that the anchoring or docking devices are external to the delivery conduit and engage a pusher or pusher line / tube; Figure 20 A schematic representation of an exemplary embodiment of a system for delivering anchoring or docking devices is shown, illustrating that the anchoring or docking devices are outside the delivery conduit and detached from the actuator line or tube; Figure 21 It shows that it can be used Figures 18 to 20 A perspective view of an exemplary embodiment of a pusher tool used in a system, including a stitch / thread lock or locking mechanism; Figure 22 yes Figure 21 A side cross-sectional view of the pusher tool; Figure 23 yes Figure 21 Exploded view of the rotatable component and housing of the stitch / thread lock or locking mechanism; Figure 24 yes Figure 23 Cross-sectional views of the rotatable components and the shell; Figure 25 This is a side cross-sectional view of an exemplary stitch / thread lock mechanism in the first position; Figure 26 yes Figure 25 Top cross-sectional view of the stitch / thread lock or locking mechanism; and Figure 27 It is in the second position. Figure 25 A side cross-sectional view of the stitch / thread lock or locking mechanism. Detailed Implementation

[0035] The following description and accompanying drawings, which describe and illustrate certain embodiments, are intended to demonstrate, in a non-limiting manner, several possible configurations of systems, apparatuses, devices, components, methods, etc., that can be used in various aspects and features of this disclosure. As an example, various systems, apparatuses / devices, components, methods, etc., that may relate to mitral valve procedures are described herein. However, the specific examples provided are not intended to be limiting; for example, systems, apparatuses / devices, components, methods, etc., may be applicable to valves other than the mitral valve (e.g., in the tricuspid valve).

[0036] This document discloses embodiments of a deployment tool designed to facilitate the implantation of a prosthetic heart valve in one of the natural mitral, aortic, tricuspid, or pulmonary valve regions of the human heart, and methods of using the deployment tool. The prosthetic valve may be an expandable transcatheter heart valve (“THV”). The deployment tool can be used to deploy an anchoring or docking device that provides a more stable docking site for securing the prosthetic valve (e.g., a THV) to the natural valve region. The deployment tool includes a pusher tool or mechanism that facilitates easier and more accurate delivery and positioning of the anchoring device at the implantation site, allowing the anchoring device and the THV anchored thereto to function properly after implantation.

[0037] Examples of anchoring components / anchoring devices / dating devices are in Figure 3 As shown, other configurations or variations are possible. The anchoring or docking device 1 is a generally helical coil or includes helical coils—with multiple turns extending along the central axis of the docking device 1, wherein the coil(s) may have segments of various sizes and shapes. The docking device 1 is configured to fit optimally at the mitral and tricuspid valve locations, but in other embodiments it may be similarly shaped or modified to better accommodate other natural valve locations as well. U.S. Patent Application Serial Nos. 15 / 682,287 and 15 / 684,836 include additional examples and details of anchoring elements / anchoring devices / docks that can be used with the systems, apparatuses, devices, methods, etc., of this disclosure, each of which is incorporated herein by reference in its entirety.

[0038] The docking device 1 includes a central region / section 10 in which approximately three complete coil turns have substantially equal inner diameters. The turns of the central region 10 provide a primary landing or retention area for the THV after implantation and are therefore sometimes referred to as functional coils of the anchoring device 1, as the characteristics of these coils contribute most significantly to the retention of the valve prosthesis relative to the docking device 1 and the natural anatomy. The coils of the central region 10 are typically chosen to be slightly smaller than the outer diameter of the expanded THV to generate sufficient radial force or tension between the central region and the THV to fix them relative to each other and / or clamp the natural tissue (e.g., natural leaflets and / or chordae tendineae) between them.

[0039] The docking device 1 can be positioned within the natural valve annulus (e.g., the natural mitral or tricuspid valve annulus) by rotating or cork-screwing the distal or lead end (e.g., from the right or left atrium) through the natural valve annulus (e.g., into the right or left ventricle). Since the coil size of the central region 10 remains relatively small, the docking device 1 further includes a distal or lower region / section 20 forming the lead or surrounding coil / turn (e.g., lead ventricular coil) of the docking device 1. The lower region 20 has a larger diameter than the central region 10, allowing the distal end to be positioned wider relative to the central axis of the docking device 1 to facilitate navigation of the distal end of the docking device around features of the natural anatomical structure, such as chordae tendineae. As the distal end navigates around the desired anatomical structure, the smaller remaining coils can be guided around the same features, thus slightly corralling and encircling the anatomical features inward. The lower region 20 can be kept relatively short to reduce flow disturbance.

[0040] The anchoring or docking device may optionally include a low-friction sleeve, such as a PTFE sleeve, fitted around all or part of the anchoring or docking device (e.g., the leader and / or functional turn). For example, the low-friction sleeve may include a cavity in which the anchoring or docking device (or a portion thereof) is fitted. The low-friction sleeve utilizes less friction to make the anchoring or docking device easier to slide and / or rotate into place, and is less likely to cause abrasion or damage to the native tissue compared to the surface of the anchoring or docking device. After the anchoring or docking device is in place in the native valve, the low-friction sleeve may be removable (e.g., by pulling proximally on the sleeve while keeping the pusher and docking device in place), for example, to expose the surface of the anchoring or docking device—which may be or include configured portions (porous, braided, large surface area, etc.) to promote inward tissue growth.

[0041] The docking device 1 also includes an enlarged proximal or superior region 30, which constitutes a stabilizing coil (e.g., an atrial coil) for the docking device. The enlarged superior region 30 is sized and shaped to adjoin or push against the walls of natural anatomical structures (e.g., the chamber walls of the heart or atria) to enhance the ability of the docking device 1 to remain in its desired position after delivery to the implantation site and before implantation of the THV. The docking device 1 may also optionally include a generally vertical extension 40 connecting the central region 10 and the superior region / part 30 and serving as a vertical spacer—for separating the superior region 30 of the docking device 1 from the other parts and forming a vertical gap therebetween. In this way, the amount of pushing of the docking device 1 against the natural valve annulus can be reduced, thereby reducing pressure on the natural tissue. The docking device 1 may also have one or more through-holes 50 at or near the free proximal end of the superior region 30. The through-holes 50 can serve as attachment sites for, for example, delivery tools (such as pusher tools, traction sutures, etc.).

[0042] Other embodiments of the docking device may have more or fewer turns in each of the described regions, or some regions may be omitted entirely (e.g., the enlarged upper region 30). In some cases, the width or thickness of the coils of the docking device may also vary along the length of the docking device—e.g., based on the desired strength and curvature of certain coil regions. In some embodiments, additional layers, such as a high-friction overlay, may be added to the docking device to facilitate more efficient delivery and / or implantation / retention. Meanwhile, although the turns of the docking device 1 are oriented counterclockwise into the ventricle, the coils may optionally be wound in the opposite direction to facilitate counterclockwise advancement.

[0043] The docking device 1 is typically flexible and may be made of, for example, a shape memory material or include a shape memory material, such that the coil of the docking device 1 can be straightened for delivery via a delivery catheter. For mitral valve applications, the docking device 1 may be delivered to the mitral valve location—for example, from the left atrium via the atrial ground, via the atrial septum via the septum ground, or via one of a variety of other known entry points or procedures (e.g., via the apex, etc.).

[0044] Various methods and steps can be used to deliver the docking device to a natural heart valve. For example, U.S. Patent Application Serial No. 15 / 682,287 and U.S. Patent Application Serial No. 15 / 684,836—each incorporated herein by reference—describe various methods and steps that can be used. Furthermore, Figures 4A to 6 The steps of an exemplary method for delivering docking device 1 to the mitral valve location using a transseptal approach are shown, wherein the delivery system / device 400 is advanced through the interatrial septum of the heart. First refer to... Figure 4AFor example, the interatrial septum can be punctured at the fossa ovalis, and the larger guiding sheath 480 of the delivery system device 400—for example, housing and protecting the delivery catheter 410—can be advanced through the puncture port into the left atrium. Figure 4B In this procedure, the distal region of the delivery catheter 410 is advanced in a substantially straight or unactuated configuration, exiting the distal opening of the guide sheath 480 located in the left atrium. In tricuspid valve procedures, puncture, penetration, or advancement through the septum is generally not required.

[0045] Subsequently, when in the desired area of ​​the heart or the first chamber (e.g., the right atrium or left atrium), such as Figure 4C As shown, the distal region of the delivery catheter 410 itself can be bent or otherwise actuated to prepare for delivery of the docking device 1. The distal region of the delivery catheter 410 can take various shapes—for example, based on the shape of the anchoring or docking device, the delivery site, and / or the patient's anatomy. For example, Figure 4C and 4D The delivery conduit 410 delivers the docking device 1 in a clockwise direction near the A1P1 junction.

[0046] In one implementation, for example, such as Figure 7 As shown, the distal region of the delivery catheter 410 includes a first, generally straight portion 412 extending from the guide sheath 480, followed by a smoothly curved portion 414 distally curved toward the mitral valve plane. Following the smoothly curved portion 414 is a circular portion 416 that curves substantially planar with the natural valve annulus (e.g., the mitral or tricuspid valve annulus) in a counterclockwise (or optionally clockwise) direction to provide a general delivery path for the docking device 1. The distal end of the circular portion 416 may further be a flexible end 418, which may be slightly angled downwards or pointed downwards. The flexible end 418 can be used to point the distal opening of the delivery catheter 410 downwards and / or into a commissure, such as the mitral valve commissure A3P3, to facilitate easier advancement of the docking device 1 into another or second chamber of the heart (e.g., the left or right ventricle). The distal opening can be located near the joint, and the anchoring or docking device is pushed out of the opening and through the joint, or the distal opening can be located at or just through the joint, so that the anchoring or docking device is pushed out of the opening and directly into the second cavity.

[0047] The delivery catheter 410 may include multiple control or traction lines (e.g., 2-6 traction lines) arranged and configured such that applying tension to the control / traction lines causes the distal region of the delivery catheter 410 to bend and / or shape as needed. In one embodiment, at least two control / traction lines travel through the wall of the delivery catheter and terminate at different locations in the distal region, such that each control / traction line bends a different portion of the distal region when tensioned or pulled. The lines may be pulled directly or have controls (e.g., handles, tabs, knobs, buttons, inputs, and / or other components) to apply and / or release tension to the control / traction lines.

[0048] See you again Figure 4C After the distal region of the delivery catheter 410 has been actuated to the delivery position, a first stage of coil delivery can be performed, wherein the docking device 1 is extruded or pushed out from the distal opening of the delivery catheter 410, through a natural valve (e.g., the mitral or tricuspid valve, as through valvular closure), and into the second chamber or left ventricle. The distal end of the docking device 1 can then be rotated around to encircle at least some anatomical structures (e.g., leaflets and / or chordae tendineae) in the second chamber or ventricle, thereby coiling the anatomical structures within the coil of the docking device 1. This advancement of the docking device 1 through and / or out of the delivery catheter 410 can be achieved, for example, using a pusher tool 430 according to an embodiment of the invention, as will be described in more detail below. During delivery, the docking device 1 can be held in the delivery catheter 410 in a straight or relatively straight configuration to facilitate maneuverability through the delivery catheter 410. Subsequently, when the docking device 1 exits the delivery catheter 410, the docking device 1 can return to its original or shape-memory coiled or curved shape.

[0049] After the required amount of docking device 1 has been advanced into the second chamber of the heart (e.g., the left or right ventricle), the remainder of docking device 1 can subsequently be deployed or released into the first chamber of the heart (e.g., the left or right atrium) during the second phase of coil delivery. Figure 4D A method is shown for releasing the upper part or stabilizing coil / turn (e.g., atrial portion) of docking device 1 into a first chamber (e.g., left or right atrium). Figure 4D In this process, the distal region of the delivery catheter 410 is pulled backward and / or rotated, while the docking device 1 remains in substantially the same position and orientation until the entire docking device 1 is released from the delivery catheter 410. For example, as Figure 4C As shown, when the docking device 1 is pushed out of the delivery conduit 410 clockwise, the delivery conduit can then be pulled (and / or rotated counterclockwise), as... Figure 4DAs shown, the upper part or stabilizing coil / turn (e.g., the atrial portion) of the docking device 1 is released from it. During this procedure, the pusher tool 430 can be adjusted to squeeze and / or push out the anchoring or docking device 1 and / or pull / retract the delivery catheter from the delivery catheter 410 while the position of the docking device 1 relative to the natural anatomical structure (e.g., the mitral or tricuspid valve anatomy) is maintained. In this way, during or after the delivery of the upper part (e.g., the atrial portion) of the docking device 1, it is not necessary to adjust or readjust the lower part (e.g., the ventricular position) of the docking device 1. Various other methods for releasing the upper part of the docking device 1 may also be employed in other embodiments.

[0050] After the docking device 1 has been fully deployed and adjusted to the desired position at the implantation site, any connection between the pusher tool 430 and the docking device 1 (e.g., connecting sutures) can be disconnected, and the delivery device 400 can be removed from the implantation site. Figure 5 A cross-sectional view of a portion of a patient's heart is shown, with docking device 1 implanted at the mitral valve location and subsequently delivered THV. The enlarged upper / regional or stabilizing coil 30 of docking device 1 pushes against the first chamber wall (e.g., the atrial wall) to help temporarily hold docking device 1 in the desired position. THV is then advanced through docking device 1 and expanded within it. The same or different delivery catheters can be used to advance the THV.

[0051] Figure 6 A cross-sectional view of a portion of the heart is shown, in which both the docking device 1 and the THV 80 are ultimately implanted in the mitral valve location. A similar positioning can be achieved in the tricuspid valve. Typically, the THV 80 will have an expandable frame structure 81 that accommodates multiple valve leaflets 82 (e.g., artificial and / or pericardial leaflets). The expandable frame structure 81 can be, for example, self-expanding, mechanically expandable, or balloon-expandable. Upon expansion, the radial pressure between the THV 80 and the docking device 1, along with the surrounding anatomical structures, firmly holds the entire assembly in its proper position in the natural valve location (e.g., the mitral or tricuspid valve location).

[0052] As mentioned above, Figure 7 A perspective view of the distal portion of the delivery catheter 410 in an exemplary actuated delivery state is shown, but other actuated delivery states are also possible. Control or actuation of the distal segment of the delivery catheter 410 can be achieved, for example, by various controls integrated into a handle connected to the proximal end of the delivery catheter 410. Figure 8A perspective view of an embodiment of a catheter handle 420 connected to a delivery catheter 410 is shown. The catheter handle 420 includes an elongated body that is connected to the delivery catheter 410 at its distal end 420a. The body of the catheter handle 420 provides a central lumen or tubular orifice (not shown) extending through it, which is connected to the delivery catheter 410, thereby providing an inlet from the proximal end 420b of the catheter handle 420 to the delivery catheter 410.

[0053] The catheter handle 420 may further include two controls 422, 424 configured to adjust shape or otherwise actuate the distal region of the delivery catheter 410, for example... Figure 7 The configuration shown may have two regions / sections curved in different dimensions. The first control 422 may be arranged as a knob that can rotate about the catheter handle 420 (e.g., coaxial with the handle) and can control, for example, increasing or decreasing the tension in the first control line or traction line connected to the first region (e.g., the first distal region) of the delivery catheter 410 via an internally threaded member (not shown). The first control knob 422 (or optionally a second control knob 424) can be used to adjust the smooth curved section 414 to align the first region of the delivery catheter 410 with the plane of the natural valve annulus—e.g., the mitral valve plane. Simultaneously, the second control 424 may also be arranged as a knob that can also rotate about the catheter handle 420 (e.g., coaxial with the handle). The second control knob 424 can control another internally threaded member (not shown) that increases or decreases the tension in the second control line or traction line connected to the second region of the delivery conduit 410 (e.g., the second distal region, or the region distal to or adjacent to the first region), for example, to cause the circular portion 416 to bend around the natural valve annulus. In this way, the handle can independently control the degree of flexion or actuation in multiple dimensions (e.g., in each of the smooth curved portion 414 and the circular portion 416) for more precise positioning and delivery of the docking device 1. As previously discussed, additional control lines or traction lines are also possible, and these can be similar to those discussed herein, and can be controlled by additional controls or knobs similar to controls 422, 424, or by the same controls.

[0054] The handle may optionally include one or more indicators, such as indicators 422a and 424a, which respectively identify the amount of deflection or actuation of the delivery catheter 410 achieved by each control (e.g., by controls 422 and 424). Indicators 422a and 424a may each be, for example, windows integrated into the catheter handle 420 with a level indicator and key, identifying the amount by which each control actuates the delivery catheter 410. In some embodiments, the position of internal components associated with controls 422 and 424—e.g., internally threaded members, which translate axially relative to the catheter handle 420 when one of controls 422 and 424 is rotated—can also be used as level indicators via indicators 422a and 424a. In this way, the delivery catheter 410 can be controlled or adjusted more precisely. In some embodiments, a third control is also included to control the distal portion 418, or the control for the distal portion 418 may be integrated into one of the existing controls, such as a second control 424.

[0055] The catheter handle 420 may also include additional components. For example, in Figure 8 In this configuration, the catheter handle 420 includes a clamping mechanism 426, which can be locked, for example, to the position of the actuator body, actuator cable, or other components relative to the catheter handle 420. Figure 8 In this embodiment, the proximal end 420b of the handle also includes a proximal sealing and flushing port 428 to facilitate easy flushing of the handle, delivery catheter 410, and / or other components of the delivery device 400. In other embodiments, the handle for controlling the delivery catheter 410 may include any of a variety of other components that may help facilitate more precise and / or better operation of the delivery catheter 410.

[0056] While the aforementioned features of the catheter handle 420 help control the distal region of the delivery catheter 410 in preparation for delivery docking device 1, another tool or mechanism can be used to physically advance and retract the docking device 1 through the delivery catheter 410 and / or maintain its position.

[0057] Figure 9 A perspective view of an exemplary pusher tool 430 is shown, while Figure 10 It shows Figure 9 A three-dimensional partial cross-sectional view of the actuator tool 430. Figure 9 and Figure 10 The actuator tool 430 is schematically represented, and it should be understood that the actuator tool 430 can be the same as the one referenced above. Figure 8 The described catheter handle is a completely separate tool, or in some embodiments, it may be integrated into or combined with other embodiments of the catheter handle. For example, in some embodiments, Figure 8The conduit handle 420 can be designed to have an integrated actuator mechanism with features similar to or the same as the actuator mechanism discussed below, thus eliminating the need for a separate actuator tool.

[0058] Reference Figure 9 and 10 An exemplary pusher tool 430 may include a handle body 440, a knob 450, and / or a pusher line or tube 460. While various components / assemblies and arrangements are described as examples, not all of the described components / assemblies and arrangements are required. For example, one embodiment may have a handle body 440 and a knob 450 that can rotate relative to each other to cause translational or axial movement of these components relative to each other, while another embodiment may not have one or both of these components and / or these components may not be arranged for relative axial or translational movement. One embodiment may have only a knob and a pusher line / tube that rotates a rotating member—which can be wound / wound around or unwound from the rotating member to extend or retract in a delivery catheter. The pusher tool may also have a body that has a fixed relationship with the pusher line / tube without involving rotation or winding. The pusher tool may be connectable or non-connectable to a delivery catheter.

[0059] like Figure 10 As illustrated in the example, the handle body 440 may have an elongated and generally cylindrical profile. A central hole 441 extends from the proximal end of the handle body 440 toward the distal end. The central hole 441 may define a generally cylindrical space within the handle body 440 into which the base 451 of the knob 450 may extend. The distal end of the central hole 441 may be closed and may have a generally cylindrical portion 442—having a diameter reduced compared to the rest of the central hole 441. Additionally, an engaging member 443, such as a protrusion or groove, may be formed on the inner wall of the handle body 440 between the portion 442 of the central hole 441 and the other portions. The portion 442 of the hole 441 and / or the engaging member 443 may be used to assist in attaching the handle body 440 to the knob 450.

[0060] The handle body 440 may also optionally define a tunnel or channel 444 that connects the central bore 441 to the distal end of the handle body 440. The tunnel 444 may include extending substantially tangentially from a cylindrical profile of the central bore 441 (see, for example...). Figure 11 The first region 445 may include a second region 446 that rotates from the first region 445 toward the distal end of the handle body 440 to provide a passage for the actuator or actuator line 460 to travel from the center hole 441 to the distal end of the handle body 440. Figure 11It can also be seen that, in some embodiments, the inner wall of the handle body 440 may include a guide key 447, which may be a small protrusion to guide the movement of the knob 450 relative to the handle body 440. Meanwhile, at the distal end of the handle body 440, a hole, Luer interface, or other structural component 448 may be provided for attaching and securing the handle body 440 to other parts of the delivery device 400, for example, to the delivery conduit 410 or the conduit handle 420. In some embodiments, the handle housing 440 is a single piece, while in other embodiments, the handle body 440 may be multiple pieces, for example, two halves that can be assembled together.

[0061] Meanwhile, the knob 450 of the pusher or pusher tool 430 may include a base 451, an enlarged head area 452 at one end for operation and rotation by a practitioner or other end user, and a knob support 453 at the opposite end for connecting the knob 450 to the handle body 440. The base 451 of the knob 450 may be substantially cylindrical and sized to insert into a central hole 441 in the handle body 440. The diameter of the base 451 may be slightly smaller than the diameter of the central hole 441, such that the base 451 fits snugly in the central hole 441 and can still be rotated or turned while positioned in the central hole 441.

[0062] Near the distal end of the base 451 of the knob 450, a groove or passage 454 may be formed in the outer surface of the base 451 and may extend multiple times around the outer surface of the base 451 in a spiral or helical manner. The groove 454 may be sufficiently sized to retain the actuator or actuator line 460 therein, such that the actuator line 460, while retained in the groove 454, is also spirally wound around the base 451 of the knob 450. In some cases, when the docking device 1 is deployed, the thread shape in which the actuator line 460 is held is similar to the shape and size of the docking device 1 (e.g., a portion of the docking device 1), which facilitates easier shaping of the actuator line 460 through the curved distal portion of the delivery conduit 410 during delivery of the docking device 1. Furthermore, when the handle body 440 and the knob 450 are connected, the groove 454 may be fully positioned within the central hole 441 of the handle body 440. Therefore, due to the tight fit between the center hole 441 of the handle body 440 and the base 451 of the knob 450, the slot 454 can be substantially surrounded by the handle body 440 and the knob 450, such that a portion of the pusher line 460 held in the slot 454 is fully supported in all radial directions around the central axis of the pusher tool 430, thereby preventing the pusher line 460 from extending out of the slot 454 of the knob 450 or otherwise dislodging from the slot 454 of the knob 450, and ensuring the proper functioning of the pusher tool 430.

[0063] At the same time, such as Figure 12 As can be most clearly seen, a plurality of ribs 455 can be formed in the knob 450, the ribs 455 extending laterally into the slot 454. In the illustrated embodiment, the ribs 455 are arranged in pairs, extending toward each other from opposite sides of the slot 454, and the plurality of such ribs 455 pairs are positioned at least partially spaced along the length of the slot 454. In other embodiments, other rib arrangements can be formed in the slot 454, provided that the pusher line 460 can pass through each of the ribs 455 extending through the slot 454. The ribs 455 increase the friction or support pressure between the pusher line 460 and the knob 450, which results in a greater pushing capacity or force that the pusher line 460 can apply to the docking device 1—when, for example, compared to a pusher tool in which only the pushing force or support pressure is applied by the pusher tool at the proximal end of the pusher line.

[0064] At one end of the base 451, the knob 450 may have an enlarged head region 452. The enlarged head region 452 may be adapted for easy operation and rotation by a practitioner or other end user. In the illustrated embodiment, the enlarged head region 452 is also cylindrical, with a diameter larger than that of the base 451, and includes multiple longitudinal ribs or clamping members to improve clamping. In other embodiments, the enlarged head region 452 may be designed with different shapes and sizes, as long as safe and easy operation and manipulation of the knob 450 relative to the handle body 440 is achieved.

[0065] Return to reference Figure 10The knob support 453 shown is a cylindrical or tubular member that extends away from the base 451 of the knob 450 on a side opposite to the enlarged head region 452, with a diameter smaller than that of the base 451. The knob support 453 connects the knob 450 to the handle body 440. For example, the knob support 453 can be sized to fit within the smaller distal portion 442 of the central hole 441 of the handle body 440 and can have a circumferentially extending groove 456 configured to engage a protruding engagement member 443 of the handle body 440 to prevent the knob support 453 and the remainder of the knob 450 from detaching or separating from the handle body 440. In some embodiments, the positions of the groove and protrusion can be switched, or other engagement members can be used, as long as the knob 450 can rotate freely relative to the handle body 440. The knob support 453 is axially movable relative to the rest of the knob 450, such that the knob 450 remains axially movable relative to the handle body 440 to maintain alignment of the respective channels of the actuator lines 460. The knob support 453 may extend, for example, into a hole formed at the distal end of the base 451 of the knob 450, and additional engaging members (not shown) hold the knob support 453 and the rest of the knob 450 together. In one embodiment, the knob support 453 is integrally formed with the rest of the knob 450, wherein the engagement between the knob support 453 and the handle body 440 can be modified to allow the knob support 453 to also move axially relative to the handle body 440.

[0066] The pusher or pusher line 460 can connect the docking device 1 to the rest of the pusher tool 430 and can be one of the components or parts that are physically pushed or otherwise deployed, and in some embodiments, the docking device 1 is pulled or otherwise retrieved relative to the delivery conduit 410. (As in...) Figure 12 As can be seen most clearly in the figure, an exemplary pusher line 460 is shown constructed as a spring line formed by a compressed and fully contracted spring. The physical wire forming the spring and the structure of the pusher line 460 can be chosen as a whole, each with its own diameter, to give the pusher line 460 sufficient flexibility to wrap around and rotate with the knob 450, and sufficient stiffness to push and / or resist the retraction of the docking device 1 during deployment, while preventing portions of the pusher line 460 from longitudinally wrinkling within the channel 444 of the handle body 440 or the slot 454 of the knob 450. In embodiments where the pusher line 460 is constructed as a spring line, the surface of the pusher line 460 may also provide additional engaging components that interact with the ribs 455 in the slot 454, which can further enhance the thrust of the pusher tool 430.

[0067] Optionally, the actuator or actuator line / tube can be constructed in a variety of different ways. For example, the actuator or actuator line / tube can be made of or include polymer tubing, can be a laser-cut thiocyanate tube with a polymer coating, can be a coil or spring, or can be constructed of or include any other form of flexible tubing, provided that axial pressure can be applied against the actuator or actuator line / tube with minimal or no axial compression, so that the actuation of the docking device 1 is not impaired by the construction of the actuator or actuator line 460.

[0068] exist Figure 13 In one embodiment shown, an exemplary actuator or actuator tube / line 460' is constructed using a hysteresis tube, which is laser-cut or otherwise cut to provide multiple segments (e.g., three segments) with different flexibility. Figure 13 The illustrated actuator 460' can be coupled with Figures 9 to 12 The illustrated actuator tool 430 is used separately. A first segment 461' can be formed from an uncut thallium tube, such that the first segment 461' forms the stiffest part of the actuator or actuator tube 460'. A second segment 462' adjacent to the first segment 461' can be formed by cutting the thallium tube, having discontinuous cuts, and the discontinuous cuts can optionally have a decreasing axial spacing in the direction from the first segment 461' toward the third segment 463'. In this way, the second segment 462' is stiffer in the region closer to the first segment 461', where the spacing between the cuts is larger, and becomes more flexible toward the third segment 463', where the spacing between the cuts is smaller. Finally, the third segment 463' can be formed by cutting the thallium tube, having discontinuous cuts (e.g., discontinuous cuts maintained at a constant small interval), such that the third segment 463' is the most flexible of the three segments in the actuator or actuator tube 460'. In this or similar manner, the actuator or actuator tube 460' can be customized such that some sections provide stronger support while others allow greater flexibility, for example, the section near the distal end of the actuator 460', which is manipulated by the distal loop of the delivery conduit 410. In other embodiments, different flexible sections can be formed in various different ways. In some embodiments, a small portion near the distal end of the actuator 460' can remain uncutable to impart additional strength to the distal end 464' of the actuator 460'.

[0069] Now refer to Figure 14 The actuator or actuator line / tube 460 has a distal end 464 constructed in a non-invasive manner. Regarding Figures 9 to 12 Discussion of actuator / actuator line 460 or about Figure 13 The discussed actuator / actuator tube 460', or any other actuator or actuator line / tube, may be used with... Figure 14 The distal end 464 is similar or identical to that shown. A non-traumatic distal portion can be formed, for example, by adding an additional braid or other relatively soft layer 465 to the distal end 464, and / or by forming a round or other more curved distal region, to prevent damage to the docking device 1, any connecting sutures, delivery catheter 410 and / or the patient's anatomy.

[0070] Furthermore, in some embodiments, the docking device 1 may be physically attached to or connected to the distal end 464 of the pushers 460, 460' in order to maintain the connection and / or enable retrieval or pulling of the docking device 1 relative to the delivery conduit 410. For example... Figure 14 As shown, the actuator 460 (or 460') may be formed with a central cavity 466 extending therethrough and an opening 467 at the distal end of the actuator 460. The cavity 466 and opening 467 provide passageways through which a retrieval or connection line (e.g., a retrieval or connection suture) or other connecting components can be passed to connect the actuator or actuator line / tube to the proximal end of the docking device 1. Figure 14 As shown, the connecting or retrieving suture 468 can pass through cavity 466, exit from opening 467, and pass through a hole near the proximal end of docking device 1 to connect docking device 1 to pusher 460. The retrieving suture 468 can pass through the distal end 464 of pusher 460, return through central cavity 466, and extend to the proximal region of pusher tool 430. In one embodiment, both ends of the retrieving suture 468 can be anchored to or connected to the handle or other part of pusher tool 430, for example, to locking knob 457 located on the enlarged head region 452 of knob 450 (see, for example...). Figure 9 The locking knob 457 provides easy access to the end of the retrieved thread / suture 468, wherein, for example, the retrieved thread or connecting thread / suture 468 is cut and / or one side of the retrieved thread / suture 468 is pulled until the retrieved thread / suture 468 passes through the through hole 50 on the docking device 1, separating the docking device 1 from the pusher or pusher line / tube.

[0071] exist Figure 15 In another embodiment shown, an exemplary locking knob or an exemplary stitch / thread lock or locking mechanism is illustrated. Figure 15 The suture locking mechanism or thread locking mechanism 470 can be a component added to an existing assembly (e.g., an assembly that does not have an integrated suture locking device). In some embodiments, the suture / thread lock or locking mechanism 470 is integrated itself with other parts of the pusher or pusher tool 430. The suture / thread locking device 470 can be used without... Figures 9 to 12 The illustrated pusher tool 430 can be used in the absence of [other tools]. For example, the stitch locker 470 can be used without [other tools]. Figures 9 to 12The pusher tool shown is in the case of... Figure 13 The illustrated pusher or pusher tube 460' is used together. The stitch lock or locking device 470 may include a generally T-shaped body having a first portion 471 and a second portion 472 extending away from the central region of the first portion 471.

[0072] The rotatable member 473 can be connected to and rotatable relative to the first portion 471 of the body, and may have a handle 474 extending to the outside of the first portion 471 at one end. The handle 474 facilitates rotation or turning of the rotatable member 473 relative to the first portion 471 of the body. At the end of the rotatable member 473 opposite to the handle 474, an engagement member 475 may be provided for anchoring or retaining one or more ends of the connecting or retrieved thread / suture 468 thereon. Simultaneously, a hole 476 may extend through the second portion 472 of the body to connect the first portion 471 of the body to a distal opening of the body. The hole 476 may form a suture pathway or channel that allows the retrieved thread / suture 468 to extend through the second portion 472 to the first portion 471 of the body, where the retrieved thread / suture 468 may engage the rotatable member 473. Here, the retrieved thread / suture 468 may pass through or through the rotatable member 473 and may be anchored using the engagement member 475. When the retrieved suture 468 is anchored to the rotatable member 473, the rotatable member 473 can act as a spool for the retrieved suture 468, allowing the rotating handle 474 to adjust the amount of the retrieved suture 468 wound around the rotatable member 473 to increase or decrease the usable length and / or tension of the retrieved suture 468. A slot / window / cutout 469 can be formed in the suture / thread locking mechanism 470 (e.g., in the second section 472), and the retrieved / connecting suture 468 can form a loop, with one end or portion of the suture or loop extending across, through, and / or through the slot / window / cutout 469, exposing that portion within the slot / window / cutout 469 and allowing for cutting by running a tool / scalpel along the slot / window / cutout. Cutting the suture in this manner can disrupt the loop and / or release the suture, allowing it to be withdrawn and pulled away from the docking device 1, thereby releasing the docking device 1.

[0073] A latch and / or other locking / locking mechanism may also be incorporated into the suture / thread locking mechanism 470 to maintain the position or tension of the retrieved suture / thread 468. In some embodiments, the suture / thread lock or locking mechanism 470 further includes a sealing cap 477 for connecting the suture / thread lock or locking mechanism 470 to other components of the delivery device 400, and for example for maintaining a steady state via the delivery device 400 when the delivery device 400 is in use.

[0074] Return to reference Figure 10 and 11 When the individual components of the pusher tool 430 are assembled together, the complementary features between the different components also contribute to smoother and more robust operation of the pusher tool 430. For example, the first region 445 of the tunnel 444 in the handle body 440 is positioned to align with the slot 454 of the knob 450 and extends tangentially to the helical winding direction of the slot 454. In this way, the pusher or pusher line / tube 460 can seamlessly extend, advance, and retract between the slot 454 on the knob 450 and the first region 445 of the tunnel 444 in the handle body 440 without any rotation or change of direction between these components.

[0075] Additionally, the guide key 447 on the handle body 440 can also be positioned along the spiral winding direction of the slot 454, for example, slightly distal to the opening of the first region 445 of the tunnel 444. The guide key 447 can be configured, sized, and shaped to allow the guide key 447 to extend into the slot 454 and to allow the slot 454 to slide on the guide key 447. When the guide key 447 is positioned slightly distal to the first region 445 of the tunnel 444 in which the actuator line 460 extends, the portion of the slot 454 reaching the guide key 447 is empty and does not hold the actuator or actuator line / tube 460. In this way, the guide key 447 can act as a track or guide for axially positioning the knob 450 relative to the handle body 440 and preventing excessive axial displacement therebetween. In this way, when the knob 450 is rotated, the guide key 447 can always ensure that the slot 454 is concentered and axially aligned with the tangential first region 445 of the tunnel 444. The design of the pusher tool 430 also facilitates the storage of relatively long pushers or pusher cables / tubes 460 in a relatively compressed space within the handle body 440. For example, in one embodiment, a handle only about 20 cm long can accommodate and deploy pushers or pusher cables / tubes 460 with a functional length or stroke length of up to 80 cm.

[0076] Now refer to Figures 16A to 17BThe operation of the pusher tool in the exemplary method is described using the delivery of the connecting device to the natural mitral valve. The pusher tool 430 shown is intended for use with a catheter handle, such as catheter handle 420, which can be locked at least to the handle body 440 of the pusher tool 430. In some embodiments, the handle body 440 of the pusher tool 430 is integrally formed with the catheter handle 420. However, in each embodiment, the handle body 440 of the pusher tool 430 and the catheter handle 420 can be coupled together such that the catheter handle 420, the delivery catheter 410, and the handle body 440 of the pusher tool 430 rotate simultaneously. Thus, when the knob 450 of the pusher 430 remains positioned, rotation of the catheter handle 420 will rotate the distal region of the delivery catheter 410, while also rotating the handle body 440 of the pusher tool 430 relative to the knob 450, resulting in the pusher or pusher line / tube 460 being advanced or retracted relative to the delivery catheter 410—depending on the direction of rotation. During the deployment and retrieval of docking device 1, this arrangement provides complete control of docking device 1 relative to delivery conduit 410.

[0077] Now for reference Figure 16A and 16B After the distal region of the delivery catheter 410 has been actuated or adjusted to the appropriate delivery configuration, the handle body 440 of the pusher tool 430 (and the catheter handle 420, if present) can remain positioned or secured, while the knob 450 rotates clockwise, for example, relative to the rest of the delivery device 400. Rotation of the knob 450 disengages the pusher or pusher line / tube 460 from the slot 454 of the knob 450 (see, for example...). Figure 10 The actuator or actuator line / tube 460 is advanced through a dedicated passage formed by tunnel 444 and exits from the distal end of handle body 440. This displaces the actuator or actuator line / tube 460 distally relative to delivery catheter 410, and thus pushes the distal end of the actuator or actuator line / tube 460 against the proximal end of docking device 1 to advance docking device 1 distally from the distal opening of delivery catheter 410. As described above, docking device 1 can be released or pushed away from delivery catheter 410 in a direction substantially coinciding with or slightly angled downward relative to the plane of natural valve annulus, and then advanced through natural valve. For example, in mitral valve, docking device 1 is advanced through valve closure and into left ventricle. Optionally, all or only the first part of the anchoring / docking device is advanced and / or deployed at natural valve or natural valve annulus in this manner.

[0078] The various anchoring / docking devices, delivery catheters, and / or guide sheaths described in various locations throughout this disclosure may include one or more radiopaque markings to facilitate the delivery and proper positioning of the anchoring / docking device, delivery catheter, and / or guide sheath. For example, observing the relative movement and position of the radiopaque markings on the anchoring / docking device and the delivery catheter can indicate when a predetermined or first portion of the anchoring / docking device (e.g., some or all of the surrounding turns / coils and / or functional turns / coils) has been ejected from the delivery catheter and entered the natural valve annulus. In one instance, by observing the relative movement of the radiopaque markings on the anchoring / docking device and the delivery catheter (e.g., observing when they are aligned, which can indicate that the first portion has been properly deployed from the delivery catheter), the operator can rotate a knob and / or advance the pusher line / tube such that the pusher line / tube advances the anchoring / docking device until the predetermined or first portion of the anchoring / docking device has been deployed into the natural valve annulus.

[0079] Once the required amount or predetermined or first portion of the anchoring / docking device 1 (as discussed above, which can be determined by using one or more radiopaque markings on the docking device and / or delivery catheter) has been advanced into the heart chamber or ventricle (e.g., left or right ventricle) and the predetermined or first portion of the docking device 1 (e.g., ventricular coil or wrap and / or functional coil) has been satisfactorily positioned or located at the natural valve annulus, the second portion of the anchoring device (e.g., stabilizing coil / turn or atrial coil / turn) can be delivered or deployed from the delivery catheter. This can be accomplished in a variety of ways.

[0080] For example, knob 450 and / or pusher tool can be held in position or fixed, such that the pusher or pusher line / tube 460 remains in a fixed position. In this way, the ventricular coil of docking device 1 (which is connected to or fixed relative to pusher line / tube 460) can also be held in place without losing its desired position. The pusher tool, pusher and / or pusher line / tube can be locked or fixed in place (e.g., by locking or fixing its proximal end in, such as in a stabilizer, and / or by locking / holding / maintaining the knob in place) while the delivery catheter is pulled or retracted proximally. This can hold the anchoring device in place (e.g., because the anchoring / docking device is adjacent to the positioned pusher or pusher line / tube) while retracting the delivery catheter, thereby expelling the second part of the anchoring / docking device from the delivery catheter sheath. If a guide sheath is used, the guide sheath can also be locked / fixed in place when the delivery catheter is retracted (e.g., in a stabilizer). The pusher tool, delivery catheter, and / or guide sheath may be configured and / or arranged to be individually movable relative to each other and individually secured in a stabilizer or other locking / stabilizing mechanism.

[0081] exist Figure 17A and 17B Referring to the mitral valve, another method of retracting the delivery catheter is shown. With knob 450 held fixed, if properly configured, the handle body 440 of the pusher tool 430 (and the catheter handle 420, if present) can rotate relative to knob 450 in a direction opposite to the direction of rotation of knob 450, for example, counterclockwise in this embodiment, such that the distal region of the delivery catheter 410 also rotates in the same direction. The system and apparatus can be configured such that this rotational movement causes a proximal translational movement of the delivery catheter, thereby retracting the delivery catheter from the anchoring / dock device. Since the docking device 1 is held in place when the delivery catheter 410 rotates, the delivery catheter 410 can retract relative to the docking device 1, thereby releasing the second portion or atrial loop (one or more) of the docking device 1 from the delivery catheter 410 without further advancement into the left ventricle or retraction into the left atrium.

[0082] The handle body 440 of the pusher tool 430 can also rotate relative to the knob 450, such as Figure 10 and 11 As best shown, this will also result in the release of the pusher or pusher line / tube 460 from the pusher tool 430 and further distal advancement. The amount of advancement of the pusher or pusher line / tube 460 may substantially correspond to the length of the docking device 1 released into the left atrium, such that the pusher or pusher line / tube 460 provides sufficient spare portion to replace the length of the docking device 1 held in the delivery catheter 410 prior to the deployment of the atrial loop, to further facilitate holding the docking device 1 in place during the procedure.

[0083] Connecting the docking device 1 to the pusher or pusher line / tube 460 via retrieval line 468 (e.g., retrieval suture) also facilitates pulling the docking device 1, for example, to readjust or retrieve it from the implantation site. Such retrieval is possible during any stage of delivery of the docking device 1 and can be accomplished in a manner similar to the deployment of the docking device 1. For example, if adjustment of the ventricular coil of the docking device 1 is required, the position of the docking device 1 can be retracted or pulled back by rotating knob 450 in the opposite direction of advancement (e.g., counterclockwise in this embodiment). In one embodiment, to hold the docking device 1 in the same position while retracting the proximal portion of the docking device 1 (e.g., a portion of the stabilizing coil / turn or atrial coil / turn) into the delivery catheter 410, the handle body 440 of the pusher tool 430 or the knob can be rotated in the opposite direction of advancement (e.g., clockwise in this embodiment). It is possible to retrieve the docking device partially or completely back into the delivery catheter.

[0084] Once the docking device 1 has been delivered to the desired location, the retrieved suture / thread 468 can be released, for example, using the locking knob 457 or the suture / thread locking mechanism 470 (e.g., by cutting along the groove / window / incision 469 to cut a portion of the suture), allowing the docking device 1 to separate from the pusher suture / tube 460, and the delivery device 400 to be removed from the implantation site. The THV 80 can then be delivered into and expanded within the docking device 1, thus completing the valve replacement procedure.

[0085] In other embodiments, the delivery device 400 can be configured to deliver docking devices of different shapes and orientations. For example, although the above examples discussed clockwise advancement of docking device 1, docking device 1 can be adapted to deliver coil anchors that also advance counterclockwise, for example, Figure 3 The docking device 1 shown is an example of this arrangement. In this configuration, the rotation of each component will be related to... Figures 16A to 17B The methods discussed in the text are in the opposite direction. For example, knob 450 will rotate counterclockwise to push docking device 1 out of delivery conduit 410, while knob will rotate clockwise to retract docking device 1 into and / or further into delivery conduit.

[0086] Figures 18 to 20 The figure illustrates an exemplary embodiment of a system 500 (which may include the same or similar components as system 400) for delivering a docking device 501 to a natural valve of a patient's heart. System 500 includes a guide sheath 502 that houses and protects a delivery catheter 504, which may be similar to or identical to the previously described sheath 480 and delivery catheter 410. The delivery catheter 504 includes a distal opening 506 and a central lumen 508. System 500 also includes a pusher tool 510 and a pusher or pusher line / tube 512, which may be the same as or similar to the previously described pushers or pusher lines / tubes 460, 460'.

[0087] The actuator line / tube 512 includes a proximal end 514 fixedly attached to the actuator tool 510 and a distal end 516 having a device adjacent surface 518. The actuator line / tube 512 may include a central cavity 520 extending from the proximal end 514 through the actuator line / tube 512 to the distal end 516. The central cavity 520 may open at the proximal end 514 through a proximal opening 522 and at the distal end through a distal opening 524.

[0088] The docking device 501 may include a proximal end 526 having one or more holes 528 extending laterally through the proximal end 526. The system 500 may include a retrieval line / suture 530 connecting the docking device 501 to the pusher tool 510. The retrieval line / suture 530 may extend from the pusher tool 510, through a proximal opening 522, through a central cavity 520, exit from a distal opening 524, through the holes 528 in the docking device 501, and return to the pusher tool 510 along the same path (e.g., forming a loop). Therefore, the retrieval line / suture 530 may have a first lead (leg) 532 and a second lead 534 extending from the pusher tool 510 to the docking device 501.

[0089] The pusher tool 510 may include a suture / thread locking mechanism that is the same as or similar to the suture / thread locking mechanism 470. For example, the pusher tool 510 may include a rotatable member 536 around which the retrieved suture / thread 530 can be wound (e.g., the same as or similar to the rotatable member 473 of the suture / thread locking mechanism 470, or the rotatable member may take any other form). By rotating the rotatable member 536, the amount by which the retrieved suture / thread 530 extends from the pusher tool 510 can be lengthened or shortened. Figure 18 As shown, the rotatable member 536 can be rotated such that the retrieved thread / suture 530 pulls the proximal end 526 of the docking device 501 against the adjacent surface 518 of the device. In this position, the docking device 501 is firmly held against the pusher thread / tube 512, causing the docking device 501 and the pusher thread / tube 512 to move in unison. In this way, the pusher tool 510 moves along the longitudinal axis A of the system 500 ( Figure 18 The movement of the delivery conduit 504 relative to the delivery conduit 504 can move the docking device 501 within the central cavity 508 of the delivery conduit 504.

[0090] like Figure 19 As shown, the pusher tool 510 and the pusher line / tube 512 can be advanced relative to the delivery conduit 504, such that the docking device 501 is pushed out of the central cavity 508 and through the distal end 506 of the opening of the delivery conduit 504. However, the retrieved suture 530 remains taut, such that the proximal end 526 of the docking device 501 remains against the device adjacent surface 518 of the pusher line / tube 512.

[0091] like Figure 20As shown, once the docking device 501 is pushed out of the delivery conduit 504 by the pusher or pusher line / tube 512, the pusher tool 510 can create a spare portion in the retrieval line / suture 530 by allowing the release of an additional length of retrieval line / suture 530. When the tension in the retrieval line / suture 530 has been removed, the proximal end 526 of the docking device 501 no longer remains engaged with the device adjacent surface 518 of the pusher line / tube 512. During delivery, the docking device 501 can be held in the delivery conduit 504 in a relatively straight configuration to facilitate manipulation through the delivery conduit 504. After exiting the delivery conduit 504 and removing the tension in the retrieval line / suture 530, the docking device 501 can return to its original coiled or curved shape, and placement of the docking device 501 can be completed.

[0092] However, since the retrieved suture / suture 530 remains connected to the docking device 501, the docking device 501 can be retrieved or readjusted from the implantation site—this is done by retracting the retrieved suture / suture 530 through the central lumen 520 of the pusher suture / tube 512 until the proximal end 526 of the docking device 501 is pulled abutted against the device-adjacent surface 518 of the pusher suture / tube 512. The pusher suture / tube 512 can then be pulled back through the central lumen 508 of the delivery catheter 504, and, if necessary, the docking device 501 can be pulled completely or partially into the delivery catheter 504 for removal or replacement.

[0093] If the docking device 501 is properly inserted, it can be separated from the retrieval line / suture 530, for example, by cutting or severing the retrieval line / suture 530 or a portion thereof. Once the docking device 501 is separated from the retrieval line / suture 530, the pusher tool 510 and the retrieval line / suture 530 can be retracted, leaving the docking device 501 in place. For example, one end of the retrieval line / suture 530 can be cut at or near the rotatable member 536 (e.g., in a slot / window / cutout identical or similar to slot / window / cutout 469). Once the end is cut, the rotatable member 536 can be rotated to pull the cut end down along the pusher line / tube 512 into, through, and back into the pusher line / tube 512 to permanently release the docking device 501. In another embodiment, either or both ends of the retrieved thread / stitch 530 may be cut, wherein either end is pulled through the hole 528 to release the docking device 501.

[0094] The thruster tool 510 can be configured in various ways. Any tool capable of propelling the docking device 501 through the delivery conduit 504 can be used, simultaneously allowing for controlled deployment and retrieval of the docking device 501. See also Figure 21 and 22As shown in the illustrated exemplary embodiment, the pusher tool 510 includes a body 600 having a front portion 602 adapted to receive and securely attach to a proximal end 514 of the pusher line / tube 512 and a rear portion 604 including a suture / thread locking mechanism 606—which may be the same as or similar to the suture / thread locking mechanism 470 described above. The body 600 may typically be elongated and may include a channel 608 extending from the front portion 602 to the suture / thread locking mechanism 606. Figure 22 The main body 600 and the channel 608 can be formed as a single integral structure, or they can be formed from multiple attached components and fittings. The number and type of components and fittings can vary in different embodiments.

[0095] The front portion 602 can be securely attached to the proximal end 514 of the actuator or actuator line / tube 512 by any suitable means such as friction fitting, threaded connection, adhesive, fastener, or other suitable connection. As shown in the illustrated embodiment, the front portion 602 may include a first connector 610 having a hole 612 sized to tightly receive the proximal end 514 of the actuator line / tube 512, such that the central cavity 520 of the actuator line / tube 512 can communicate with the channel 608 in the body 600. As shown in the illustrated embodiment, the central cavity 520 can be along the axis B of the channel 608 (…). Figure 22 It is aligned coaxially with channel 608.

[0096] As shown in the exemplary embodiment illustrated, the first connector 610 can be attached to the flushing fitting 620. The first connector 610 can be attached to the flushing fitting 620 by any suitable means such as friction fitting, threaded connection, adhesive, fastener, or other suitable connection. As shown in the illustrated embodiment, the flushing fitting 620 can be a T-fitting fitting having a flushing port 622 in fluid communication with the channel 608. The flushing port 622 can be connected to or is connectable to the flushing system 624 (…). Figure 21 For example, it is used to introduce flushing fluid such as brine into channel 608. Sealing assembly 626 ( Figure 22 It can be provided in the flushing fitting 620, or otherwise provided between the flushing fitting and the locking mechanism 606, to prevent flushing fluid from entering the locking mechanism 606.

[0097] The suture / thread locking mechanism 606 can be attached to the remainder of the body 600 of the pusher tool 510 in any suitable manner, such as friction fitting, threaded connection, adhesive, fastener, or other suitable connection. As shown in the illustrated embodiment, the suture / thread locking mechanism 606 can be attached to the flushing fitting 620 via a second connector 630 and a sealing cap 632. In one exemplary embodiment, the connector 630 and the sealing cap 632 allow the suture / thread locking mechanism 606 to rotate relative to the remainder of the body 600. The second connector 630 may include a distal end 634 received within a hole 636 in the flushing fitting 620, a proximal end 638 received within a hole 640 in the suture / thread locking mechanism 606, and a rearward shoulder 642 positioned between the distal end 634 and the proximal end 638.

[0098] The sealing cap 632 may include a first end 644 and a second end 646, the first end 644 being threaded into the flushing fitting 620, and the second end 646 having a hole 648 through which a second connector 630 extends. A shoulder 642 may be adjacent to the inner surface 650 of the sealing cap 632 near the hole 648 to attach the second connector 630 to the flushing fitting 620. When the sealing cap 632 is rotated, the distal end 634 compresses and seals the gasket along the path of the retrieved thread / stitch 530.

[0099] The suture / thread locking mechanism 606 can be configured in various ways. Any mechanism capable of anchoring the retrieved suture / thread 530, controlling the deployment and retrieval of the retrieved suture / thread 530, and locking the retrieved suture / thread 530 at the designated deployment can be used. See reference... Figure 23 and 24 In one embodiment, the suture / thread locking mechanism 606 includes a body 660 (which may be generally T-shaped) having a first portion 662 and a second portion 664 extending away from the central region of the first portion 662. A rotatable member 536 is accommodated in the first portion 662 and is rotatable about axis C relative to the first portion 662 of the body 660.

[0100] The second portion 664 may include a hole 640 for receiving the proximal end 638 of the second connector 630. The hole 640 allows the suture channel 608 to extend through the second portion 664 of the body 660 to reach the rotatable member 536 in the first portion 662 of the body 660.

[0101] The second portion 664 may include a slot, window, or cutout 670 (e.g., the same as or similar to slot / window / cutout 469) that provides an entrance from the outside of the second portion 664 to the hole 640. The slot / window / cutout 670 can be configured in various ways. For example, the location, size, and shape of the slot / window / cutout 670 may vary for different embodiments. Any opening provided to the hole 640 that allows a user to access the retrieved thread / stitch 530 within the hole 640 can be used. In the illustrated embodiment, the slot / window / cutout 670 is formed as a semi-circular vertical channel.

[0102] A separator 672 can be positioned within a hole 640 adjacent to the slot / window / cutout 670. The separator 672 can be configured in various ways. It can be used to separate the two leads of the retrieved thread / stitch 530 in the hole 640, thereby allowing one of the leads to be present in any structure within the slot / window / cutout 670. In the illustrated embodiment, the separator 672 is a locating pin arranged vertically in the hole 640 and is sized and positioned such that one lead of the retrieved thread / stitch 530 can pass through one side of the separator 672, while the other lead of the retrieved thread / stitch 530 can pass through the opposite side of the separator 672.

[0103] As shown in the illustrated embodiment, the first portion 662 may be formed by a generally cylindrical sidewall 680 defining a hole 682 extending from a first end 684 of the first portion 662 to a second end 686 opposite to the first end 684. However, in some embodiments, the first portion 662 may be configured to have a shape other than cylindrical. The first portion 662 may include a radial lip 690 extending from the outer side of the cylindrical sidewall 680 near the first end 684.

[0104] The stitch / thread locking mechanism 606 may also include a component or structure for locking the rotational position of the rotatable member 536 relative to the first portion 662. This component or structure can be configured in various ways. Any component or structure capable of locking the rotational position of the rotatable member 536 relative to the first portion 662 can be used, such as, for example, a spline connection. As shown in the illustrated embodiment, the first end 684 of the first portion 662 may include a gear-shaped first opening 692 in the end wall 694 of the first end 684. The first opening 692 may be axially aligned with the hole 682 along axis C. The gear shape of the opening 692 may be formed by alternating radially extending protrusions 696 and circumferentially spaced recesses 697 surrounding the first opening 692. As will be described in detail below, the protrusions 696 may serve as stops to prevent rotation of the rotatable member 536. The number and size of the protrusions 696 and recesses 697 may vary in different embodiments. As shown in the illustrated embodiment, the gear shape of the opening 692 may be formed by nine alternating protrusions 696 and recesses 697. Each protrusion 696 and each recess 697 may be separated from the next protrusion and recess by approximately 40 degrees, respectively.

[0105] The first end 684 may include a countersunk hole 698 adjacent to the first opening 692. The countersunk hole 698 may be coaxially aligned with the hole 682, but may have a larger diameter than the hole 682. The first portion 662 of the suture / thread locking mechanism 606 may also include a hole 700 extending through a cylindrical sidewall 680, opposite to and coaxial with the hole 640 of the second portion 664.

[0106] The second end 686 of the first portion 662 may include a second opening 702 opposite to and coaxial with the hole 682. The second opening 702 may have the same size and shape as the hole 682, or it may have a different size and shape. As shown in the illustrated embodiment, the second end 686 may include a tapered or beveled outer edge 704.

[0107] One or more stops 706 may be positioned along the inner surface of the sidewall 680 between the hole 700 and the second opening 702. The one or more stops 706 may be configured in various ways, such as, for example, the shape, size, and number of stops. Any structure capable of restricting axial movement of the rotatable member 536 may be used. As shown in the illustrated embodiment, one or more stops 706 may include a pair of locating pins. For example, the first portion 662 may include a pair of offset holes 708 (…). Figure 23 Each offset hole is sized to receive one of the stops 706 and extends through the first portion 662 to form two opposing grooves 710 along the inner surface of the hole 682. When received in the offset hole 708, the stop 706 reduces the cross-sectional size of the hole 682 to create a blocking point.

[0108] The rotatable member 536 of the suture / thread locking mechanism 606 can be configured in various ways. Any configuration capable of engaging the retrieved thread / suture 530 for deployment and retrieval can be used. For example, the rotatable member 536 can be configured such that manually rotating the rotatable member 536 will cause the retrieved thread / suture 530 to be wound or unwound from a portion of the rotatable member. As shown in the illustrated embodiment, the rotatable member 536 may include a handle 720 and a rod 722 extending from the handle 720. The handle 720 may be positioned at one end of the rotatable member 536 and extend to the exterior of the first portion 662 of the T-shaped body 660. The handle 720 can be configured in various ways. Any configuration facilitating rotation or turning of the rotatable member 536 relative to the first portion 662 of the T-shaped body 660 can be used.

[0109] The rod 722 may typically be cylindrical and sized to be received within the bore 682 of the first portion 662. As shown in the illustrated embodiment, the rod 722 may include a proximal portion 724 adjacent to the handle 720, a first diameter reduction portion 726 adjacent to the proximal portion 724, a second diameter reduction portion 728 separated from the first diameter reduction portion 726 by a radial lip 730, and a distal portion 732 adjacent to the second diameter reduction portion 728. The rod 722 may include an internal passage 734 extending axially from the proximal portion 724 through the distal portion 732 to form an opening 736 in the distal portion 732.

[0110] The proximal portion 724 may include a radially extending protrusion 740. Figure 22 The protrusion 740 is configured to interact with the gear-shaped first opening 692. Specifically, the protrusion 740 is sized to be received within one of the recesses 697 between the two protrusions 696. The protrusion 740 can be configured in various ways. For example, the protrusion 740 can be integrally formed with the rod 722, or it can be a separate component attached or otherwise connected to the rotatable member 536. As shown in the exemplary embodiment, the rod 722 may include a radially extending hole 742 near the handle 720, which receives the protrusion 740 in the form of a locating pin.

[0111] The first diameter reduction portion 726 may include a cross hole 744 communicating with the internal passage 734. In the illustrated embodiment, the cross hole 744 extends through the first diameter reduction portion 726 generally perpendicular to the longitudinal axis C and has the same or similar diameter as the channel 608. However, in some embodiments, the cross hole 744 may be configured with different shapes, sizes, and orientations.

[0112] like Figure 22As shown, the rotatable member 536 may include an anchoring or engaging member 750 for anchoring or retaining one or more ends of the retrieved thread / suture 530. The anchoring or engaging member 750 may be configured in various ways. Any component capable of anchoring or retaining one or more ends of the retrieved thread / suture 530 may be used. As shown in the illustrated embodiment, the anchoring or engaging member 750 may be cylindrical or generally cylindrical and sized to be received in an internal passage 734 at the distal portion 732 of the rotatable member 536. The anchoring or engaging member 750 may include a pair of passages 752 that extend generally parallel to the internal passage 734. Each passage 752 may be designed to receive an end of the retrieved thread / suture 530. In some embodiments, the anchoring or engaging member 750 may include more or fewer than one pair of passages 752.

[0113] Reference Figure 22 During assembly, the rod 722 of the rotatable member 536 is slidably and rotatably received within the hole 682 of the first portion 662 of the stitch / thread locking mechanism 606, and the handle 720 extends from the first end 684. The cross hole 744 of the rotatable member 536 may communicate with the channel 608, and the anchoring or engaging member 750 may be positioned in the internal passage 734 at the distal portion 732 of the rotatable member 536.

[0114] The first lead 532 and the second lead 534 of the retrieved thread / suture 530 can extend from the docking device 501, through the pusher or pusher line / tube 512, through the channel 608, and through the cross hole 744 into the rotatable member 536. From the cross hole 744, the first lead 532 and the second lead 534 of the retrieved thread / suture 530 can enter the internal passage 734 and extend along the internal passage 734 to the anchoring or engaging member 750 at the distal portion 732. At the anchoring or engaging member 750, the first lead 532 of the retrieved thread / suture 530 can extend through one of a pair of passages 752, and the second lead 534 of the retrieved thread / suture 530 can extend through the other of the pair of passages 752. Once through the passages 752, the first lead 532 and the second lead 534 can be anchored in place, for example by tying or knotting their ends together.

[0115] In one embodiment, when the first lead 532 and the second lead 534 of the retrieved thread / suture 530 extend through the channel 608 and pass through the separator 672, the first lead 532 of the retrieved thread / suture 530 passes along one side of the separator 672, and the second lead 534 passes along the opposite side of the separator 672, such that the separator 672 separates the two leads 532, 534.

[0116] The rod 722 of the rotatable member 536 can be positioned within the bore 682 such that the second diameter reduction portion 728 is adjacent to a groove 710 on the inner surface of the bore 682. When inserted into the groove 710, the stop 706 extends at least partially into the second diameter reduction portion 728 and extends between the radial lip 730 and the distal portion 732 of the rod 722. Therefore, axial movement of the rotatable rod 722 of the rotatable member 536 within the bore 682 can be limited by the stop 706.

[0117] The rotatable member 536 is axially movable within the hole 682 between a first position and a second position. The stitch / thread locking mechanism 606 may include a biasing member 754 that biases the rotatable member 536 to the first position. The biasing member 754 may be configured in various ways. Any biasing member capable of biasing the rotatable member 536 to the first position may be used. As shown in the illustrated embodiment, the biasing member 754 may be a spring positioned between the radial lip 690 and the lower surface 756 of the handle 720 to bias the handle 720 away from the T-shaped body 660.

[0118] See Figure 25 and 26 As shown, in the illustrated first position, the distal portion 732 of the rod 722 engages the stop 706 to prevent further upward axial movement of the rotatable member 536. The cross hole 744 is positioned to communicate with the channel 608. In the illustrated embodiment, the cross hole 744 is coaxially aligned with the channel 608. However, in some embodiments, the cross hole 744 does not need to be coaxially aligned with the channel 608 in the first position.

[0119] At the proximal portion 724 of the rod 722, a protrusion 740 can be positioned in one of a plurality of recesses 697 between adjacent protrusions 696. Thus, the radially extending protrusions 696 can prevent rotation of the rotatable member 536 by engaging the protrusions 740. Therefore, the first position can be a locked position.

[0120] Reference Figure 27 In the second position shown, the rotatable member 536 is moved downward relative to the T-shaped body 660, biased against the biasing member 754. The radial lip 730 engages the stop 706 to prevent further downward axial movement of the rotatable member 536. Although the crosshole 744 is not aligned with the channel 608, it is still positioned to communicate with the channel 608. At the proximal portion 724 of the rod 722, the protrusion 740 is positioned in a plurality of recesses 697 located at the first opening 692 and a radially extending protrusion 696 (see...). Figure 23 and 24 The countersunk hole 698 is located in the first part 662 below. Therefore, the rotatable member 536 can rotate about axis C. Therefore, the second position is a rotatable position.

[0121] In operation, the user can move the handle 720 to a second position—for example, by pushing the handle 720 downward relative to the T-shaped body 660. In the second position, the rotatable member 536 can be rotated via the handle 720. Rotating the rotatable member 536 in a first direction—such as, for example, clockwise—can cause a portion of the retrieved thread / stitch 530 to be wound around the first diameter-reduced portion 726 of the lever 722; thus, the amount by which the retrieved thread / stitch 530 extends from the thread / stitch locking mechanism 606 is retrieved or reduced. Rotating the rotatable member 536 in a second direction opposite to the first direction—such as, for example, counterclockwise—can cause a portion of the retrieved thread / stitch 530 to be unwound from the first diameter-reduced portion 726 of the lever 722; thus, the amount by which the retrieved thread / stitch 530 extends from the thread / stitch locking mechanism 606 is deployed or increased. In one implementation, to lock the amount of deployed retrieved suture / stitch 530, the user can release handle 720, allowing biasing member 754 to move rotatable member 536 to a first position, thereby preventing rotation of rotatable member 536. Locking retrieved suture / stitch 530 by wrapping it around rotatable member 536 and preventing rotatable member 536 is a friction locking method, which reduces the risk of tearing of retrieved suture / stitch 530 compared to locking methods based on clamping retrieved suture / stitch 530, especially in the case of fine retrieved suture / stitch.

[0122] To release the docking device 501 from the retrieval line / stitch 530, the first lead 532, the second lead 534, or both leads of the retrieval line / stitch 530 can be cut at the slot / window / cutout 670 of the second portion 664 of the body 660. For example, in the illustrated embodiment, since the first lead 532 and the second lead 534 of the retrieval line / stitch 530 are separated by a separator 672 in the channel 608 adjacent to the slot / window / cutout 670, only one lead is present at the slot / window / cutout 670, and the other lead is located behind the separator 672. Therefore, the single lead in front of the separator 672 can be cut without considering cutting the other lead. Once one of the first or second leads 532, 534 is cut, the cut or severed end of the retrieved thread / suture 530 can be pulled toward the docking device 501 through the central cavity 520, through the hole 528 in the docking device 501 to release the docking device 501, and return through the central cavity 520 of the pusher thread. This can be done in several ways. For example, the handle 720 can be simply pressed down and rotated to wind the retrieved thread / suture 530 onto the rod 722. Alternatively, the thread / suture locking mechanism 606 can be separated from the pusher tool 510 by separating the first end 644 of the sealing cap 632 from the flushing fitting 620. Since the retrieved thread / suture 530 is attached to the thread / suture locking mechanism 606, removing the thread / suture locking mechanism 606 from the rest of the pusher tool 510 will pull the retrieved thread / suture 530 through the hole 528 and separate the docking device 501.

[0123] Optionally, the various actuators described herein (e.g., actuator lines, actuator tubes, etc.) may have a coating on their top and / or inside. For example, the actuator may have an inner cavity lined with PTFE to allow the line (e.g., a suture) to be actuated non-invasively through the lined cavity.

[0124] The various manipulations and controls of the aforementioned systems and devices can be automated and / or motorized. For example, the aforementioned controls or knobs can be buttons or electrical inputs that arouse the actions described with respect to the controls / knobs above. This can be accomplished by connecting some or all moving parts (directly or indirectly) to a motor (e.g., an electric motor, pneumatic motor, hydraulic motor, etc.) actuated by the button or electrical input. For example, when actuated, the motor can be configured to tension or relax the control line or traction line described herein to move the distal region of the catheter. Additionally or alternatively, when actuated, the motor can be configured to translate or axially move the actuator relative to the catheter, thereby moving and / or inserting or removing the anchoring or docking device within the catheter. Automatic stops or precautions can be built in to prevent damage to the system / device and / or the patient, for example, to prevent components from moving beyond a certain point.

[0125] Additional systems, apparatus, components, and methods are included in U.S. Provisional Patent Application Serial No. 62 / 435,563, filed December 16, 2016, entitled "Deployment tools and methods for delivering an anchoring device for a prosthetic valve at a natural valve annulus," and in another application filed December 15, 2017, entitled "Deployment systems, tools, and methods for delivering an anchoring device for a prosthetic valve." The relevant PCT patent application serial number PCT / US2017 / 66854 describes “VALVE”, each of which is incorporated herein by reference, and systems, apparatuses, components, methods, etc., with necessary modifications may be integrated with or used with the systems, apparatuses, methods, etc., described herein.

[0126] In various other embodiments, any or all of the different components / assemblies from the different embodiments described above may be combined or modified based on, for example, the shape and configuration of the docking device to be delivered and / or the anatomy or needs of each patient. Even if no embodiment is described, a component / assembly described with respect to one embodiment may be included in other embodiments. Similarly, steps described with respect to one method may be included in other methods, even if no method is described. The steps described at various points in this disclosure may be combined even if they are separate from each other.

[0127] Furthermore, although only the transseptal delivery of docking device 501 has been discussed in detail, the tools and methods can be modified in other embodiments for other delivery procedures, such as transatrial or transapical delivery. Additionally, as already discussed, although embodiments of docking device 501 and the delivery device have been generally discussed above regarding valve replacement at the mitral valve location, similar docking devices and delivery methods can also be applied to other valve locations, such as the tricuspid, pulmonary, or aortic valve locations. When applied to valves other than the mitral valve, docking devices similar to or identical to those described above can also provide a more secure landing area for THVs at those locations.

[0128] For the purposes of this specification, 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 to all novel and non-obvious features and aspects of the various disclosed embodiments, individually and in various combinations and sub-combinations with each other. 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 particular advantages or problems to be solved.

[0129] Although some of the disclosed embodiments are described in a specific order for ease of presentation, it should be understood that this descriptive approach includes rearrangement unless the specific language described below requires a particular order. For example, in some cases, the sequentially described operations may be rearranged or performed simultaneously. Furthermore, for simplicity, 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 "provide" or "achieve" to describe the disclosed methods. These terms are high-level abstractions of the actual operations performed. The actual operations corresponding to these terms may vary depending on the specific implementation and can be readily identified by those skilled in the art.

[0130] Given the many possible implementations to which the principles of this disclosure can be applied, it should be recognized that the illustrated embodiments are merely preferred examples and should not be considered as limiting the scope of this disclosure. Rather, the scope of this disclosure is defined by the appended claims.

Claims

1. A delivery device for delivering a docking device to a natural valve annulus of a patient's heart, the delivery device comprising: Delivery catheter with a first lumen; and A pusher tool, the pusher tool comprising: An actuator, slidably housed within a first cavity, the actuator having a distal portion and a proximal portion, and a second cavity extending from the proximal portion to the distal portion; A locking mechanism, which is fixedly attached to the proximal portion of the actuator; and A retrieval line extends from the locking mechanism through the second cavity to the docking device to connect the docking device to the pusher tool; The locking mechanism includes a rotatable member connected to the retrieval line, the rotatable member having a first position that locks the amount by which the retrieval line extends from the locking mechanism and a second position that allows the amount by which the retrieval line extends from the locking mechanism to be increased or decreased.

2. The delivery device of claim 1, wherein the pusher comprises a helically wound wire.

3. The delivery device of claim 1, wherein the pusher comprises a patterned cut tube.

4. The delivery device according to any one of claims 1 to 3, wherein the locking mechanism includes a line entry window for allowing a single end of the retrieval line to enter.

5. The delivery device of claim 4, further comprising a separator in the window, wherein a first end of the retrieval line is on a first side of the separator, and a second end of the retrieval line is on a second side of the separator.

6. The delivery device according to any one of claims 1 to 5, wherein the rotatable member includes a first passage extending along the rotation axis of the rotatable member and a second passage intersecting the first passage, wherein the retrieval line extends through the first passage and the second passage.

7. The delivery device according to any one of claims 1 to 6, wherein the locking mechanism includes a brake that prevents the rotatable member from rotating when the rotatable member is in the first position.

8. The delivery device according to any one of claims 1 to 7, wherein the brake allows the rotatable member to rotate when the rotatable member is in the second position.

9. The delivery device according to any one of claims 1 to 8, wherein the rotatable member is biased to the first position.

10. A method for delivering a docking device to a natural valve of a patient's heart, the method comprising: Connect the docking device to the pusher tool using a wire; Position the docking device and the pusher tool within the delivery conduit; Position the distal region of the delivery catheter within the atrium of the heart; The actuator of the actuator tool is advanced distally through the delivery conduit, wherein the actuator pushes the docking device within the lumen of the delivery conduit; and Rotate the components of the pusher tool to change the amount of line extending from the pusher tool.

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