CN116472008A - Heart valve device delivery system and associated method of operation - Google Patents

Abstract

Disclosed herein are delivery systems for implanting a heart valve repair device. In some embodiments, a delivery system includes a delivery catheter, a hub shaft extending through the delivery catheter, and a mandrel extending through the hub shaft. The delivery catheter is configured to hold the valve repair device in a compressed configuration. The hub shaft includes a hub configured to releasably engage a first portion of the valve repair device, and the mandrel includes a plug configured to releasably engage a second portion of the valve repair device. The hub shaft and the mandrel are independently movable to axially extend/compress the valve repair device as the valve repair device is unsheathed from the delivery catheter. When the valve repair device is properly positioned, the hub may be actuated to release a first portion of the valve repair device and the plug may be actuated to release a second portion of the valve repair device.

Description

Heart valve device delivery system and associated method of operation

Related Application Cross Reference

This application claims priority and benefit to U.S. Patent Application No. 17/194,113, filed March 5, 2021, entitled "Delivery System and Associated Method of Operation of a Heart Valve Device," and U.S. Patent Application No. 17/024,667, filed September 17, 2020, entitled "Delivery System and Associated Method of Operation of a Heart Valve Device," both of which are incorporated herein by reference in their entirety.

technical field

The present technology generally relates to delivery systems for implanting heart valve devices via minimally invasive procedures, such as endovascularly.

Background technique

Mitral regurgitation, mitral valve prolapse, and/or mitral stenosis can interfere with the normal function of the mitral valve. Mitral regurgitation occurs when the leaflets of the mitral valve fail to coapt into apposition at peak systolic pressure, allowing blood to leak from the left ventricle into the left atrium. Several structural factors may affect the proper closure of the mitral valve leaflets. For example, dilation of the mitral annulus caused by myocardial dilation may prevent proper coaptation of the leaflets during systole. Other conditions involve stretching or tearing of the chordae (the tendons that connect the papillary muscles to the underside of the mitral valve leaflets), which may also affect the normal closing of the mitral valve annulus. For example, rupture of the chordae may cause valve leaflets to prolapse into the left atrium due to insufficient tension on the leaflets. Abnormal reflux can also occur when the papillary muscle is damaged (eg, due to ischemia) such that the affected papillary muscle cannot contract sufficiently to close normally during systole.

Mitral valve prolapse occurs when the mitral valve leaflets bulge abnormally into the left atrium, which can also lead to mitral regurgitation. The normal function of the mitral valve may also be affected by mitral stenosis, or narrowing of the mitral valve orifice, which prevents the left ventricle from filling during diastole.

Mitral regurgitation is usually treated with diuretics and/or vasodilators to reduce the amount of blood flowing back into the left atrium. Other treatments, such as surgical approaches (open and endovascular), have also been used to repair or replace the native mitral valve. For example, cinching or excision of portions of the dilated annulus are typical repairs. The tightening of the valve annulus has been accomplished by implanting annular or peri-annular rings that are generally fixed to the valve annulus or surrounding tissue. Other repair procedures also involve sewing or clipping the valve leaflets into partial apposition to each other. Alternatively, more invasive procedures replace the entire valve with a mechanical valve or biological tissue. These invasive procedures are usually done through large open thoracotomy and are therefore very painful, have high morbidity, and require a long recovery period.

However, in many repair and replacement procedures, the durability of the device or improper sizing of the annuloplasty ring or replacement valve can lead to complications. Additionally, many repair procedures rely on the skill of the cardiac surgeon, as improper or inaccurate placement of sutures can affect the success of the procedure.

The mitral valve presents unique challenges compared to other heart valves because portions of the mitral annulus have limited radial support from surrounding tissue and the mitral valve has an irregular, unpredictable shape. For example, the anterior wall of the mitral valve is limited only by a thin wall that separates the mitral annulus from the lower portion of the aortic outflow tract. Therefore, significant radial forces on the mitral annulus are unacceptable, as they may lead to collapse of the inferior aortic tract with potentially fatal consequences. Another challenge with mitral valve anatomy is that the maze of chordal tendons in the left ventricle makes navigating and positioning a deployment catheter more difficult compared to other heart valves. In view of the difficulties associated with prior procedures, there remains a need for simple, effective, and less invasive devices and methods for treating malfunctioning heart valves. Additionally, there is a need for effective and less invasive delivery systems for delivering implantable cardiac devices to the mitral valve due to the difficulty of delivering the device to the mitral valve as well.

Brief description of the drawings

Many aspects of the disclosure can be better understood with reference to the following figures. Components in the figures are not necessarily drawn to scale. Instead, emphasis is placed on clearly illustrating the principles of the disclosure.

1 is a diagram of a mitral valve accessed by a delivery system, in accordance with an embodiment of the present technology.

2A and 2B are top and side views, respectively, of an implantable device that can be delivered to the heart of a subject (eg, patient) using a delivery system in accordance with an embodiment of the present technology.

3 is a perspective side view of a delivery system configured in accordance with embodiments of the present technology.

4 is an enlarged isometric view of the distal portion of the delivery system of FIG. 3 and the implantable device of FIGS. 2A and 2B in a partially deployed position in accordance with an embodiment of the present technology.

5A-5C are enlarged side views of the hub attachment mechanism of the delivery system of FIG. 3 in a first position, a second position, and a third position, respectively, in accordance with an embodiment of the present technology.

5D-5F are cross-sectional side views of the hub attachment mechanism of FIGS. 5A-5C in a first position, a second position, and a third position, respectively, in accordance with an embodiment of the present technology.

6A-6C are an isometric view, a proximally facing partial cross-sectional isometric view, and a distally facing partial cross-sectional isometric view, respectively, of the hub shaft handle of the delivery system of FIG. 3 in accordance with an embodiment of the present technology.

7A and 7B are side isometric and enlarged partial cross-sectional side views, respectively, of a distal plug on the mandrel of the delivery system of FIG. 3 in accordance with an embodiment of the present technology.

8A-8D are respectively distal-facing isometric views, partially transparent side views, partially transparent enlarged top views, and partially transparent proximal-facing isometric views of the mandrel handle of the delivery system of FIG. 3 in accordance with embodiments of the present technology.

8E-8H are partially transparent side views, a proximally-facing front view, a distal-facing isometric view, and another distal-facing isometric view, respectively, of the clip mount assembly and the tightening mount assembly of the mandrel handle of FIGS. 8A-8D configured in accordance with embodiments of the present technology.

9 is a flowchart of a process or method for operating a delivery system to place an implantable device within a patient in accordance with an embodiment of the present technology.

10A-10I are side views illustrating a distal portion of the implantable device and delivery system during various stages of the method of FIG. 9 in accordance with an embodiment of the present technology.

11 is a flowchart illustrating a process or method for releasing an implantable device from a delivery system in accordance with an embodiment of the present technology.

12A-12C are side views illustrating a distal portion of the implantable device and delivery system during various stages of the method of FIG. 11 , in accordance with an embodiment of the present technology.

13A is a side view of the distal portion of the delivery catheter of FIG. 3 configured in accordance with embodiments of the present technology.

13B is an enlarged cross-sectional view of a portion of the delivery catheter of FIG. 3 taken along line 13B-13B in FIG. 13A.

14A - 14D are respectively a distal-facing isometric view, a partially transparent side view, a partially transparent enlarged top view, and a partially transparent proximally-facing isometric view of a mandrel handle configured in accordance with additional embodiments of the present technology.

15 is an enlarged side view of a hub assembly configured in accordance with additional embodiments of the present technology.

16A and 16B are enlarged side and front isometric views, respectively, of a hub assembly configured in accordance with additional embodiments of the present technology.

Detailed description of the invention

Aspects of the present disclosure generally relate to delivery systems for implanting a medical device, such as a valve repair device or a prosthetic heart valve, into the heart of a subject (eg, a human patient). For example, in several embodiments described below, a delivery system includes a delivery catheter that maintains an implantable medical device in a compressed configuration, a hub shaft extending through the delivery catheter, and a mandrel extending through the hub shaft. The hub shaft includes a hub that releasably engages a first portion of the medical device, and the mandrel includes a plug that releasably engages a second portion of the medical device. When the medical device is unsheathed from the delivery catheter, the hub and the mandrel are independently movable (eg, translatable) relative to each other to axially elongate or axially compress the medical device. When the medical device is properly positioned in the heart, the hub can be actuated to release the first portion of the medical device, and the bung can be actuated to release the second portion of the medical device.

In some embodiments, the medical device is configured to be implanted at the mitral valve of the subject's heart. In such an embodiment, the medical device may be implanted at the mitral valve by at least partially unsheathing the medical device from the delivery catheter in the left atrium above the mitral valve. The medical device is then longitudinally compressed to improve ease of steering by moving one or both of the hub shaft and the mandrel relative to each other. Next, a guide catheter, delivery catheter, hub shaft, and/or mandrel can be used to control the direction of the medical device toward and through the mitral annulus such that a portion of the medical device extends into the left ventricle to capture a portion of one or more native leaflets of the mitral valve and anchor the medical device in the inferior annulus behind the leaflets. After the medical device is determined to be properly positioned and functioning, the hub and plug can be actuated to disengage the medical device, thereby anchoring the medical device to the tissue surrounding the mitral valve.

Specific details of several embodiments of the present technology are described herein with reference to FIGS. 1-12D . However, the technology may be practiced without some of these specific details. In some instances, well-known structures and techniques commonly associated with catheter-based delivery systems, prosthetic heart valves, etc. have not been shown in detail in order not to obscure the technology. The terminology used in the description presented below is intended to be interpreted in its broadest reasonable manner, even though it is used in conjunction with the detailed description of certain specific embodiments of the present disclosure. Even certain terms may be emphasized below; however, any terms that are intended to be interpreted in any restrictive manner will be disclosed and specifically defined in the Detailed Description of the Invention.

The drawings depict embodiments of the technology and are not intended to limit the scope thereof. The dimensions of the various elements depicted are not necessarily drawn to scale and these various elements may be arbitrarily enlarged for improved legibility. Component details may be abstracted in the figures to exclude details such as component locations and certain precise connections between such components when such details are not necessary for a complete understanding of how to make and use the technology. Many of the details, dimensions, angles, and other features shown in the figures are merely illustrative of certain embodiments of the present technology. Accordingly, other embodiments may have other details, dimensions, angles, and features without departing from the spirit or scope of the technology.

With respect to the terms "distal" and "proximal" in this specification, unless otherwise stated, the terms may provide relative positions of parts of the catheter subsystem with reference to an operator and/or a position in the vasculature. Furthermore, as used herein, terms such as "rearwardly", "forwardly", "upwardly", "downwardly" are not meant to limit the referenced components to use in a particular orientation. It should be understood that such designations refer to the orientation of the referenced components as shown in the figures; the system of the present technology may be used in any orientation that suits the user.

The headings provided herein are for convenience only and should not be construed as limiting the disclosed subject matter.

I. Selected Embodiments of Implantable Devices and Associated Valve Anatomy

1 is a diagram of a mitral valve accessible by a delivery system, in accordance with an embodiment of the present technology. The anterior leaflet has a semicircular shape and is attached about two-fifths of the annular circumference. Motion of the anterior leaflet defines an important boundary between the inflow (diastole) and outflow (systole) tracts of the left ventricle. The posterior leaflet of the mitral valve has a crescent shape and is attached about three-fifths of the annular circumference. The posterior leaflet usually has two well-defined indentations that divide the leaflet into three separate sectors, labeled P1 (lateral sector), P2 (medial sector), and P3 (medial sector). The three corresponding segments of the anterior leaflet are labeled A1 (lateral segment), A2 (medial segment), and A3 (medial segment). The leaflet indentation helps to open the posterior leaflet during diastole.

As shown in Figure 1, the mitral valve has anterolateral and posteromedial commissures, which define a unique region where the anterior and posterior leaflets come together upon insertion into the annulus. Sometimes the commissures are present as well-defined lobular segments, but usually this area is a subtle structure that can be identified using the following two anatomical landmarks: (a) the axis of the corresponding papillary muscle, and (b) the commissural chordae, which have a specific fan-like configuration. A few millimeters of valve tissue separate the free edge of the commissure from the annulus.

The mitral valve is the atrioventricular valve that separates the left atrium from the left ventricle. The mitral annulus forms the anatomical junction between the left ventricle and the left atrium. The fixed ends of the leaflets are attached to the annulus. The anterior portion of the mitral annulus attaches to the fibrous triangle and is usually better developed than the posterior annulus. The right fibrous triangle is an area of dense junction between the mitral valve, tricuspid valve, noncoronary valve of the aortic valve, and membranous septa. The left fibrous triangle is located at the junction of the left fibrous boundaries of the aortic and mitral valves.

The mitral annulus is poorly developed at the insertion site of the posterior leaflet. This segment is not attached to any fibrous structure, and the fibrous skeleton is discontinuous in this region. When mitral regurgitation occurs with dilation of the left atrium or left ventricle, the posterior portion of the annulus tends to increase its circumference. The mitral valve annulus is saddle-shaped, and during systole, the commissural area moves proximally, that is, toward the roof of the atrium, while annular contraction also narrows the circumference. Both processes contribute to achieving leaflet coaptation, which can be adversely affected by annular dilation and calcification. The mitral annulus is surrounded by several important anatomical structures, including the aortic valve, coronary sinus, and circumflex arteries. Therefore, cardiac devices implanted at the mitral valve need to be positioned to accommodate the asymmetrical anatomy of the mitral valve without affecting surrounding cardiac structures.

2A and 2B are top and side views, respectively, of an implantable device 200 that can be delivered to the heart of a subject (eg, a human patient) using a delivery system in accordance with an embodiment of the present technology. 2A and 2B together, in the illustrated embodiment, the implantable device 200 is a valve repair device having an atrial fixation member 202 (also referred to as an "anchor member" or "rim") and a coaptation member 204 (also referred to as a "baffle") extending in a downstream direction from the atrial fixation member 202. Atrial fixation member 202 is configured to anchor implantable device 200 to cardiac tissue adjacent to the native mitral valve annulus and position engagement member 204 at a desired location relative to the native valve anatomy of the heart. Engagement member 204 is configured to replace at least a portion of one or more native leaflets of the heart valve and provide a prosthetic engagement surface for at least a portion of one or more other native leaflets of the heart valve. For example, when implantable device 200 is deployed across the mitral annulus, engagement member 204 may extend anterior to the central portion of the posterior leaflet (i.e., P2 of the posterior leaflet), pushing the posterior leaflet toward the ventricular wall such that engagement member 204 is positioned to engage the anterior leaflet during systole. Implantable device 200 is configured relative to a flow axis VA ( FIG. 2B ) along the direction of atrial-to-ventricular blood flow and a transverse axis HA ( FIG. 2A ) at an angle (eg, orthogonal) to flow axis VA. Implantable device 200 has a posterior portion P (e.g., a first side portion), an anterior portion A (e.g., a second side portion), an upper end portion S (e.g., a first end portion), and an inferior end portion I (e.g., a second end portion).

In some embodiments, implantable device 200 may include some features substantially similar or identical to implantable devices described in: (i) U.S. Patent Application No. 16/044,447, filed July 24, 2018, entitled "Artificial Leaflet Device," (ii) International Patent Application No. PCT/US2018/061126, filed November 14, 2018, entitled "Leaflet Extensions for Heart Valve Leaflets" , (iii) U.S. Patent Application No. 16/745,246, filed January 16, 2020, entitled "Implantable Coaptation Assist Devices Having Sensors, and Related Systems and Methods," and/or (iv) U.S. Patent Application No. 16/817,464, filed March 12, 2020, and entitled "Heart Valve Repair Devices Having Annuloplasty Features, and Related Systems and Methods," each of which is incorporated herein by reference in its entirety. Any of several prosthetic valve repair or replacement devices may similarly be used with delivery systems in accordance with the present technology, including complete mitral valve replacement devices. Also, in addition to mitral valve devices, other valve repair or replacement devices may be delivered to the tricuspid valve, aortic valve, and pulmonary valve using the delivery system according to the present invention.

Atrial fixation member 202 may be formed from a mesh, such as a braid or a laser cut stent-like structure, including a plurality of interconnected wires or struts 206 that together define a plurality of openings or cells 208 (eg, diamond-shaped openings) arranged in one or more rows. Struts 206 may be configured to self-expand from a collapsed delivery state (not shown) to the expanded, deployed state shown in FIGS. 2A and 2B . Struts 206 may be formed from any biocompatible material, such as stainless steel, nickel-titanium alloys (eg, Nitinol), and/or other suitable scaffolding materials. Atrial fixation member 202 may have a generally circular, elliptical, or D-shaped shape in the deployed state and define an open central lumen 211 (also referred to as an "opening") that allows blood to pass therethrough along flow axis VA. When implantable device 200 is configured to repair a native mitral valve, atrial fixation member 202 may be shaped to conform to the left atrial wall just above the mitral annulus to secure implantable device 200 to supraannular tissue. After a period of time (eg, 3 days, 2 weeks, 1 month, 2 months) after implantation, atrial fixation member 202, or portions thereof, is covered with a layer of tissue, and this tissue ingrowth permanently adheres implantable device 200 to the atrial wall. In some embodiments, atrial fixation member 202 has a semicircular or other shape that does not extend completely around the perimeter of the native valve. In some embodiments, the atrial fixation member 202 may also or alternatively include one or more portions that press against the subannular tissue to provide subannular device fixation.

In some embodiments, the atrial fixation member 202 can include a connector 205 configured (eg, sized, shaped, and/or positioned) to mate with a mating feature on the delivery system, as described in detail below with reference to FIGS. 5A-5F . As shown in FIG. 2B , for example, connector 205 may extend from strut 206 such that connector 205 is positioned near or at upper end portion S of implantable device 200 . In some embodiments, atrial fixation member 202 includes one or more eyelets 207 configured to receive one or more tendons (e.g., cinch tendons 439 shown in FIG. 4 ) to facilitate packaging (e.g., compression), delivery, orientation, and/or retrieval of implantable device 200. For example, tendons may help facilitate constriction (eg, radial compression) of atrial fixation member 202 . The eyelet 207 may be a metallic portion of the atrial fixation member 202 or may be a separate wire/wire formed into a loop and attached to the atrial fixation member 202 .

2A and 2B, engagement structure 204 extends away from the downstream end portion of atrial fixation member 202 along flow axis VA, and at least a portion of engagement member 204 extends radially inward from atrial fixation member 202 into central lumen 211 to approximate the closed position of the native leaflets. The engagement member 204 may be substantially stationary (eg, with little movement) during the cardiac cycle such that the position of the engagement member 204 relative to the atrial fixation member 202 is at least substantially fixed in the deployed state. Thus, unlike the native leaflets that move back and forth to open and close the native valve, engagement member 204 remains stationary during diastole and systole.

The engagement member 204 can have an anterior portion 212 ( FIG. 2B ) having a smooth, atraumatic surface for engaging at least a portion of one or more native leaflets, and a posterior portion 214 ( FIG. 2B ) configured to displace and optionally engage at least a portion of another native leaflet. Engagement member 204 may be fabricated from a plurality of struts forming a basket-like or frame-like structure (e.g., mesh structure, laser cut stent frame) with an at least partially hollow interior and a covering (e.g., fabric) extending over at least a portion of the struts to provide a smooth suitable surface for engagement at front portion 212. The covering may also extend along the rear portion 214 over the struts and between the front portion 212 and the rear portion 214 in a manner that forms lateral side walls. The septum 204 or portions thereof may be integral with the atrial fixation member 202 such that, for example, the engagement member 204 is made from the same frame that includes the struts 206 . In other embodiments, the septum 204 may be a separate structure that is attached to a portion of the atrial fixation member 202 during manufacture. In some embodiments, septum 204 may comprise a structure attached to septum 204 and/or biocompatible foam attached to atrial fixation member 202 .

In the illustrated embodiment, septum 204 also includes a normally closed clip 209 depending from its posterior surface (obscured in FIG. 2A ), which can be opened to extend behind the native leaflet that engagement member 204 displaces. Clips 209 may grasp the native leaflets and/or engage inferior annular cardiac tissue for inferior annular stabilization of implantable device 200 . For example, in some embodiments, clip 209 reaches below the central portion of the posterior leaflet (ie, P2) as far as the inferior annulus. A tendon (made of suture or nitinol wire) can actuate the clip 209 via a lever attached to the clip 209 . The lever can be Nitinol wire or laser cut Nitinol or Cobalt-Chromium sheet.

As shown in FIG. 2A , the septum 204 may also include a delivery attachment member 203 (shown in phantom) within the hollow interior of the septum 204 . The delivery attachment member 203 may be a threaded nut or other type of connection configured to mate with a corresponding portion (eg, a screw) of the delivery system, as described in more detail below with reference to FIGS. 4 , 7A, and 7B. In some embodiments, delivery attachment member 203 is accessible via tabs or openings 201 ( FIG. 2A ) formed in septum 204 (eg, in the portion of the septum facing upper end portion S of implantable device 200 ).

Implantable device 200 may be inserted via the femoral vein sheath to pass through the inferior vena cava to the right atrium. Implantable device 200 is then inserted into the left atrium via puncture of the interatrial septum. In several applications, implantable device 200 is delivered to a target location within the mitral valve to function normally. This implies proper positional settings along the flow axis VA, correct radial positional settings relative to the central axis of the valve, correct rotational orientation for specific landmarks such as the medial (P2) portion of the native posterior leaflet, and correct angular positional settings relative to the flow and transverse axes. In some embodiments, it is also possible to reposition implantable device 200 during the delivery procedure to, for example, correct misalignment or improper positioning. During deployment and release of the implantable device 200, the delivery system can maintain the implantable device 200 in a fixed position at the desired location and in the desired orientation relative to the native valve. Additionally, the delivery system can be configured to allow implantable device 200 to be resheathed, repositioned, and/or removed prior to release from the delivery system. The delivery system of the present technology can achieve all the above-mentioned advantages in a user-friendly system. Additionally, several embodiments of delivery systems according to the present technology have a small overall diameter, such as about 15 to 30 French.

II. Selected Embodiments of Implantable Devices and Associated Valve Anatomy

Figure 3 is a perspective side view of a delivery system 310 configured in accordance with embodiments of the present technology. Delivery system 310 may be used to deliver an implantable device, such as implantable valve repair device 200 of FIGS. 2A and 2B , to the heart of a subject (eg, a human patient). In the illustrated embodiment, the delivery system 310 includes four nested/coaxial catheter/shaft structures: (i) an outer guide catheter 312, (ii) a delivery catheter 314 (also referred to as a "cannula") configured to extend at least partially through the guide catheter 312, (iii) a hub shaft 316 configured to extend at least partially through the delivery catheter 314, and (iv) a mandrel 318 (collectively referred to as "catheters 312-318" or "shafts 312-3 18") is configured to extend at least partially through the hub axle 316. Conduits 312 - 318 may operate independently and/or move relative to each other to facilitate deployment of implantable device 200 . More specifically, in the illustrated embodiment (i) guide catheter 312 is coupled to guide catheter handle 322, (ii) delivery catheter 314 is coupled to delivery catheter handle 324, (iii) hub 316 is coupled to hub handle 326, and (iv) mandrel 318 is coupled to mandrel handle 328 (collectively "handles 322-328" or "handle assembly"). In some embodiments, delivery system 310 further includes dilator assembly 319 configured to be advanced/retracted through guide catheter 312 prior to being introduced into delivery catheter 314 , hub 316 , and/or mandrel 318 .

In some embodiments, the handles 322-328 and/or portions of the conduits 312-318 are coupled/mounted to a common handle support assembly 320 (also referred to as a "rack assembly" or "control rack") that facilitates relative movement between the respective conduits 312-318 while maintaining the handles 322-328 in a stable supported position and inhibiting unwanted movement therebetween. Support assembly 320 can include a proximal fixation portion 321 (e.g., a first bracket), a distal fixation portion 323 (eg, a second bracket), and one or more rails 325 extending at least partially between the proximal fixation portion 321 and the distal fixation portion 323. In the illustrated embodiment, guide catheter handle 322 is removably mounted to distal fixation portion 323 .

As shown in FIG. 3 , support assembly 320 may also include a plurality of mounts 327 (individually identified as first through third mounts 327 a - 327 c ), which are slidably coupled to one or more rails 325 . The first mount 327a is configured to receive and secure the delivery catheter handle 324, and includes a first actuation member 329a (e.g., a wheel, slider, knob, button) for individually moving the first mount 327a—and the delivery catheter handle 324 and delivery catheter 314 coupled thereto—to move linearly along the track 325 relative to the other of the handles 322-328. The second mount 327b is positioned proximally of the first mount 327a and is configured to receive and secure the hub axle handle 326 . Similarly, the second mount 327b includes a second actuation member 329b for independently moving the second mount 327b and the hub shaft handle 326 . Likewise, a third mount 327c is positioned proximally of the second mount 327b and is configured to receive and secure the mandrel handle 328 and includes a third actuation member 329c for moving the third mount 327c and the mandrel handle 328 independently. In the illustrated embodiment, support assembly 320 also includes a linear drive mechanism 330 (e.g., screw drive, rack, and pinion) configured to collectively advance/retract delivery catheter handle 324, hub shaft handle 326, and mandrel handle 328 without moving the handles relative to each other. In some embodiments, linear drive mechanism 330 is coupled to only a subset of handles 322 - 328 and/or system 310 may include more than one linear drive mechanism to linearly advance one or more of handles 322 - 328 .

Guide catheter 312 and delivery catheter 314 may each have a different stiffness along their length and/or may be a controllable direction catheter that allows deflection of catheters 312, 314 along one or more axes. For example, in some embodiments, guide catheter handle 322 includes a guide actuation member 331 (eg, a wheel, lever, knob, slider) that is actuatable to deflect the distal portion of guide catheter 312 . More specifically, guide actuation member 331 may be coupled to a pull wire attached to a pull ring secured at a distal portion of guide catheter 312 . Similarly, delivery catheter handle 324 may include delivery actuation member 333 actuatable to deflect the distal portion of delivery catheter 314 . In some embodiments, guide catheter 312 has a diameter of less than about 30 French (eg, about 29.5 French or less) and delivery catheter 314 has a diameter of about 26 French or less.

More specifically, Figure 13A is a side view of a distal portion of a delivery catheter 314 configured in accordance with embodiments of the present technology. In the illustrated embodiment, delivery catheter 314 includes a distal tip 370, a first region 372 (e.g., a distal region) adjacent to distal tip 370, and a second region 374 adjacent to and proximal to first region 372 (e.g., a proximal region). 13B is an enlarged cross-sectional view of a portion (eg, a portion of the wall of delivery catheter 314 ) of delivery catheter 314 taken along line 13B- 13B in FIG. 13A . In the illustrated embodiment, delivery catheter 314 includes an outer sheath layer 380, an inner liner layer 382, and one or more layers of braided and/or coiled reinforcement material 384 (collectively "layers 380-384") positioned between inner liner layer 382 and outer sheath layer 380. The inner liner layer 382 and the outer jacket layer 380 may be formed of polytetrafluoroethylene (PTFE), plastic, elastomer, thermoplastic elastomer (TPE) (e.g., TPE manufactured by Arkema of Colombes, France, such as TPE manufactured under the trademark "Pebax"), nylon, and/or other suitable materials, while the layer of braided and/or coiled material 384 may be formed of wire and/or a stiffer polymer.

Referring to FIGS. 13A and 13B together, the delivery catheter 314 may also include a puller wire 376 (obscured and schematically illustrated by an outer sheath layer 380 in FIG. 13A ) extending through the lumen between some of the layers 380 - 384 and having (i) a distal end or portion coupled to a pull ring 377 (obscured and schematically illustrated by an outer sheath layer 380 in FIG. 13A ), positioned in a first region 372 proximate to the distal tip 370 , and (ii) The proximal end or portion of delivery actuation member 333 ( FIG. 3 ) coupled to delivery catheter handle 324 . Actuation of delivery actuation member 333 may pull pull wire 376 to cause deflection of first region 372 and/or second region 374 (eg, in the direction indicated by arrow D in FIG. 13B ).

In some embodiments, delivery catheter 314 may also include a spine 378 (also referred to as an "elongate member") extending at least partially through/along one or more of layers 380 - 384 . In the illustrated embodiment, the ridge 378 extends along the second region 374 rather than the first region 372 . In some embodiments, the length of the first region 372 may be between about 10-50 mm (eg, about 20 mm), and the length of the second region 374 and ridge 378 may be between about 20-80 mm (eg, about 50 mm). Ridge 378 may be formed from metal or other suitable rigid material and positioned adjacent to (eg, parallel to) pull wire 376 along second region 374 . In some embodiments, spine 378 is a wire welded (eg, tack-welded) to coil reinforcement wire 384 along second region 374 . In some embodiments, spine 378 inhibits or even prevents second region 374 of delivery catheter 376 from bending in the direction indicated by arrow D when pull wire 376 is pulled to deflect delivery catheter 314 . That is, the ridge 378 can inhibit the second region 374 from deflecting, while still allowing the first region 372 to deflect in the direction of arrow D. As shown in FIG. Thus, as shown by the dashed line in FIG. 13A , the angle θ between the first region 372 and the second region 374 after actuation of the pull wire 376 may be greater than it would be without the ridge 378 . At the same time, the ridge 378 can still allow the second region 374 to bend in a direction other than the direction of the arrow D, such as along the axis O perpendicular to the direction of the arrow D. Referring to FIG. In some aspects of the present technology, this selective flexibility may facilitate advancement of delivery catheter 314 through guide catheter 312 ( FIG. 3 ) and/or allow guide catheter 312 to bend delivery catheter 314 along axis O. That is, spine 378 may provide selective flexibility to delivery catheter 314—allowing delivery catheter 314 to bend along axis O while remaining rigid and inhibiting bending in the direction of arrow D when pull wire 376 is pulled.

During the delivery procedure using delivery system 310, the distal portion of delivery catheter 314 maintains implantable device 200 in a compressed delivery state, and upon reaching the target area (e.g., in the left atrium), deployment (e.g., unsheathing) of implantable device 200 begins by retracting delivery catheter 314 and/or advancing implantable device 200 beyond the distal end of delivery catheter 314. This allows implantable device 200 to partially expand toward the deployed state while still being releasably secured to the distal portion of hub shaft 316 and mandrel 318 . For example, in FIG. 3 , implantable device 200 is shown in a partially deployed position (also referred to as a "partially deployed state"), wherein implantable device 200 (i) has been pushed out of the distal portion of delivery catheter 314, but (ii) is still secured to hub shaft 316 and mandrel 318 to allow controlled movement (e.g., linear, rotational) and further deployment of partially deployed implantable device 200.

More specifically, FIG. 4 is an enlarged isometric view of a distal portion of delivery system 310 and implantable device 200 in a partially deployed position in accordance with an embodiment of the present technology. In the illustrated embodiment, hub shaft 316 includes a distal hub assembly 436 (described in further detail below with reference to FIGS. 5A-5F ) that releasably engages a portion of implantable device 200 (eg, connector 205 ( FIG. 2 )). Mandrel 318 includes a distal plug assembly 438 (also referred to as a “core plug” or “plug”; described in further detail below with reference to FIGS. 7A and 7B ) that extends through opening 201 in septum 204 and is releasably coupled to delivery attachment member 203 . Accordingly, relative linear translation between hub shaft 316 and mandrel 318 can lengthen and/or shorten (eg, axially, longitudinally, etc.) implantable device 200 , and more specifically, atrial fastener 202 . In the illustrated embodiment, the plug assembly 438 also includes a flexible tube 437 (eg, a coiled tube) extending therefrom to guide a tying tendon 439 (eg, a suture) to the eyelet 207 of the atrial fixation member 202 from a proximal portion of the delivery system 310 (eg, near or at the handles 322 - 328 ).

Referring to FIGS. 3 and 4 together, in some embodiments, one or more of the handles 322 - 328 may be coupled together using a device that inhibits relative rotational movement of the handles 322 - 328 . For example, in the illustrated embodiment, hub axle handle 326 is slidably coupled to spindle handle 328 via a pair of rails 332 (eg, rigid members such as rods) that inhibit or even prevent hub axle handle 326 and spindle handle 328 from rotating relative to each other. Accordingly, the hub shaft 316 and the mandrel 318 extending from the corresponding hub shaft handle 326 and mandrel handle 328 may be rotationally fixed (or at least substantially so) relative to each other during the implantation procedure. Accordingly, rails 332 can inhibit or even prevent twisting of implantable device 200 having portions coupled to hub shaft 316 and mandrel 318 that might otherwise be caused by rotation of hub shaft 316 relative to mandrel 318 during the implantation procedure. In the illustrated embodiment, the hub shaft handle 326 is coupled to the mandrel handle 328 via two rails, while in further embodiments, the two handles 326, 328 may be coupled together with a single rail, more than two rails (e.g., three, four, five, or more rails), and/or other coupling mechanisms that hold the handles 326, 328 in rotational alignment with the conduits and shafts coupled thereto. In other embodiments, the handles 326, 328 may be integrated into a single handle, including the various components and functions described in detail below with reference to FIGS. 8A-8H and/or 14A-14D. In some embodiments, other handles or subsets of handles 322-328 are similarly coupled together to avoid relative movement between handles 322-328.

5A-5C are enlarged side views of the hub assembly 436 of FIG. 4 in a first position, a second position, and a third position, respectively, in accordance with an embodiment of the present technology. 5D-5F are side cross-sectional views of hub assembly 436 in a first position, a second position, and a third position, respectively, in accordance with an embodiment of the present technology. Referring first to FIGS. 5A and 5D together, the hub assembly 436 includes an inner hub member 540 and an outer hub member 542 (also referred to as a "capsule"). For clarity, outer hub member 542 is shown partially transparent in FIGS. 5A-5F . Inner hub member 540 includes an outer surface 541, a proximal side or edge 543a, and a distal side or edge 543b. In the illustrated embodiment, the outer surface 541 of the inner hub member 540 includes a plurality/set of first recesses 544 and a plurality/set of second recesses 546 extending from the distal edge 543b toward the proximal edge 543a. First recess 544 and second recess 546 are configured (eg, set a shape, size, and/or position) to receive and secure corresponding ones of connectors 205 of implantable device 200 ( FIGS. 2A and 2B ). In some embodiments, first recess 544 and second recess 546 can have a generally similar shape, including (i) a first portion 545 having a generally elongated (e.g., rectangular) shape for receiving a portion of a corresponding one of struts 206 ( FIGS. 2A and 2B ) and (ii) a second portion 547 having a generally circular shape for receiving a corresponding one of connectors 205 ( FIGS. 2A and 2B ). In other embodiments, the first recess 544 and the second recess 546 may have other suitable shapes for receiving and securing the connector 205 and/or other features at the upper end portion S of the implantable device 200 .

In the illustrated embodiment, the first recess 544 is circumferentially spaced from the second recess 546 . That is, the first recess 544 is located along/in the first circumferential portion of the outer surface 541 , and the second recess 546 is located along the second circumferential portion of the outer surface 541 . In some embodiments, the first portion 545 of the second recess 546 is shorter than the first portion 545 of the first recess 544 (eg, in a direction extending between the proximal edge 543a and the distal edge 543b). Accordingly, the second portion 547 of the second recess 546 may be located closer to the distal edge 543 b than the second portion 547 of the first recess 544 . In some embodiments, first recess 544 is configured to receive a corresponding connector of connector 205 at anterior portion A of implantable device 200 ( FIGS. 2A and 2B ), and second recess 546 is configured to receive a corresponding connector of connector 205 at posterior portion P of implantable device 200. As described in more detail below with reference to FIGS. 5B , 5C, 5E, 5F, and 11-12D, this arrangement can facilitate a two-stage release of the implantable device 200, wherein the connectors 205 located at the posterior portion P of the implantable device 200 are released from the hub assembly 436 before the connectors 205 located at the anterior portion A of the implantable device 200. In some embodiments, inner hub member 540 may include recesses aligned for single-stage deployment, or recesses disposed about outer surface 541 to facilitate deployment in three or more stages.

In the illustrated embodiment, the outer hub member 542 includes a distal opening 549, and in the first position shown in FIGS. 5A and 5D , each of the first recess 544 and the second recess 546 are positioned proximally of the distal opening 549. Thus, in the first position, the connector 205 of the implantable device 200 is held/restrained by the outer hub member 542 within the first recess 544 and the second recess 546 .

As shown in FIG. 5D , inner hub member 540 includes/defines drive cavity 550 and lock cavity 564 that extend at least partially from proximal edge 543a toward distal edge 543b. Drive lumen 550 includes a stepped stop surface 551 such that drive lumen 550 has a larger dimension (eg, diameter) distal to stop surface 551 . Drive lumen 550 also includes a threaded portion 553 proximal to stop surface 551 . Likewise, the lock cavity 564 includes a stepped or tapered stop surface 554 such that the lock cavity 564 has a greater dimension distal to the stop surface 554 .

Hub assembly 436 may also include a lead screw 555 that extends at least partially through drive cavity 550 and operably couples inner hub member 540 to drive shaft 552 . More specifically, lead screw 555 may include a threaded outer surface 556 configured to mate/mate with threaded portion 553 of drive cavity 550 . In the illustrated embodiment, lead screw 555 includes stop member 557 configured (eg, sized and/or shaped) to engage stop surface 551 in a third position as shown in FIGS. 5C and 5F . Drive shaft 552 may be coupled to lead screw 555 by welding, adhesives, fasteners, and/or other suitable types of connections, or drive shaft 552 and lead screw 555 may be made from a single wire or rod.

As shown in FIGS. 5D - 5F , hub assembly 436 may also include a lock pin 558 that extends at least partially through lock cavity 564 and operably couples inner hub member 540 to outer hub member 542 . For example, the locking pin 558 may include a flared portion 559 configured to engage a corresponding stop surface 560 of the outer hub member 542 or another member coupled to the outer hub member 542 . Lock pin 558 also includes stop member 561 configured to engage stop surface 554 of lock cavity 564 shown in FIGS. 5B and 5E in the second position. In the illustrated embodiment, the locking pin 558 defines a release cavity 563 configured to receive a release shaft 562 . The size (eg, diameter) of the release cavity 563 may be slightly larger than the corresponding size of the release shaft 562 such that the outer surface of the release shaft 562 mates with the inner surface of the lock pin 558 when the release shaft 562 is positioned within the release cavity 563 . In some embodiments, (i) the release shaft 562 is formed of a rigid material, such as Nitinol, which is not easily compressible, while (ii) the flared portion 559 of the locking pin 558 is biased radially inwardly and/or is formed of a relatively compressible material. Thus, when the release shaft 562 is located in the release cavity 563, the release shaft 562 can radially bias/force the flared portion 559 of the lock pin 558 outward such that the flared portion 559 remains engaged with the stop surface 560 of the outer hub member 542 even when the lock pin 558 is pushed distally. In other embodiments, hub assembly 436 may include other locking mechanisms for inhibiting movement of inner hub member 540 .

Drive shaft 552 and release shaft 562 extend from hub assembly 436 , through hub shaft 316 ( FIG. 4 ), and to hub shaft handle 326 . 6A-6C are an isometric view, a proximally facing partial cross-sectional isometric view, and a distally facing partial cross-sectional isometric view, respectively, of a hub shaft handle 326 in accordance with an embodiment of the present technology. In general, hub shaft handle 326 can be manipulated/actuated by a user to actuate drive shaft 552 and/or release shaft 562 to drive movement of hub assembly 436 and release connector 205 of implantable device 200 during device deployment ( FIGS. 2A and 2B ).

Referring to FIGS. 6A-6C together, the hub axle handle 326 includes a body member 670 coupled to a gear assembly 680 . Body member 670 is shown in cross-section in Figures 6B and 6C. Body member 670 includes/defines a series of interconnected lumens, including hub shaft lumen 671 and valve lumen 672 . The hub handle 326 may also include a hub connection 673 within the body member 670 (FIGS. 6B and 6C). Hub axle 316 ( FIG. 4 ; not shown in FIGS. 6A-6C for clarity) is configured to extend through hub axle cavity 671 and is secured to hub axle connection 673 . Valve lumen 672 may receive one or more adapters, valves, sealing members, etc. (not shown) configured to maintain hemostasis and/or facilitate entry/exit of fluid (eg, blood, priming solution, etc.) into hub shaft 316 . In some embodiments, for example, a duckbill hemostatic valve (not shown) is located in valve lumen 672 .

Gear assembly 680 includes a housing 681 (FIGS. 6A and 6B; omitted in FIG. 6C for clarity) that may at least partially enclose the following components shown in FIG. 6C: body portion 682, pinion gear 683, ring gear 684, and release member 685. Body component 670 and gear assembly 680 (e.g., housing 681, body portion 682, and/or other components of gear assembly 680) together include/define an additional series of interconnected cavities extending from hub shaft connection 673, including (i) release shaft cavity 674, (ii) drive shaft cavity 675, (iii) spindle cavity 676, and (iv) one or more rail cavities 677. The spindle 318 (FIG. 3; not shown in FIGS. 6A-6C for clarity) extends through the hub shaft 316, the hub shaft connection 673, and the spindle cavity 676, to the spindle handle 328 (FIG. 3). Thus, the spindle 318 passes completely through the hub shaft handle 326 and is independently movable relative to the hub shaft handle 326 and the hub shaft 316 . Track cavity 677 is configured to slidably receive track 332 (FIG. 3; omitted from FIGS. 6B and 6C for clarity).

Drive shaft 552 ( FIGS. 5D-5F ; not shown in FIGS. 6A-6C for clarity) extends through hub shaft 316 , hub shaft connection 673 , and drive shaft cavity 675 and is fixedly coupled to pinion 683 . Referring to FIG. 6C , in some embodiments, the drive shaft 552 is secured to the pinion 683 via a set screw 686 and/or other suitable connection. Pinion 683 may be operably coupled to ring gear 684 by, for example, a mating fit of a plurality of teeth of pinion 683 and ring gear 684 . Ring gear 684 is rotatable to rotate pinion gear 683 to rotate drive shaft 552 . In some embodiments, ring gear 684 includes a plurality of grip features 687 around its perimeter and is accessible from the exterior of housing 681 . A user (e.g., a physician, other clinician, robot, or other automated mechanism), may manipulate gripping feature 687 to rotate ring gear 684, thereby driving rotation of drive shaft 552 to, for example, move hub assembly 436 (FIGS. 5A-5F ), as described in more detail below. In some aspects of the present technology, gripping features 687 are accessible around its circumference to facilitate easy gripping and rotation of ring gear 684 . In some embodiments, gear assembly 680 is configured to have a selected/selectable amount of frictional resistance that inhibits rotation of ring gear 684 to avoid rotation caused by inadvertent contact. These friction inducing features (eg, compression O-rings) and/or gear locks (not shown) operatively coupled to gear assembly 680 may prevent unintentional rotation and facilitate only purposeful actuation of gear assembly 680 .

Release shaft 562 (FIGS. 5D-5F; not shown in FIGS. 6A-6C for clarity) extends through hub shaft 316, hub shaft connection 673, and release shaft lumen 674, and is secured to release member 685 shown in FIG. 6C. The release shaft 562 may be secured to the release member 685 by a set screw 688, other mechanical connection, adhesive, welding, or other suitable connection. Release member 685 may be releasably coupled to gear assembly 680 and configured to move (eg, be pulled proximally) away from gear assembly 680 to move release shaft 562 through hub shaft handle 326 in a proximal direction. In some embodiments, the release member 685 includes one or more locking features (e.g., one or more threaded connections, compression O-rings, press-fittings) that must be disengaged to allow the release member 685 to move, e.g., to inhibit or even prevent accidental disengagement of the release member 685.

Operation of hub shaft handle 326 and hub assembly 436 for deploying/releasing implantable device 200 will now be described with reference to FIGS. 2A , 2B, and 4-6C. During delivery of the device to the target site, hub assembly 436 is in the first position shown in FIGS. 5A and 5D such that all connectors 205 of implantable device 200 are secured/contained in first recess 544 and second recess 546 by outer hub assembly 542. When the implantable device 200 is at the desired target location (e.g., at or near the mitral valve), the user can move the hub assembly 436 to the second position shown in FIGS. Rotation of drive shaft 552 rotates lead screw 555, driving (e.g., linearly translating) inner hub member 540 toward and partially away from distal opening 549 of outer hub member 542 by engagement of threaded outer surface 556 of lead screw 555 with threaded portion 553 of drive cavity 550. In the second position, at least a portion of each second recess 546 (e.g., the second portion 547 of the second recess 546) is located far enough from the distal opening 549 of the outer hub member 542 that the connector 205 at the posterior portion P of the implantable device 200 is no longer constrained by the outer hub member 542, and is thus free to disengage from the hub assembly 436. When in the second position and the posteriorly located link 205 is released, the second portion 547 of the first recess 544 remains covered by the outer hub member 542 such that the link 205 located at the anterior portion A of the implantable device 200 remains constrained by the outer hub member 542. Thus, moving the hub assembly 436 to the second position disengages the struts 206 of the posterior portion P of the atrial fixation member from the hub assembly 436 causing them to expand while inhibiting the struts 206 at the anterior portion A of the atrial fixation member 202 from disengaging and expanding from the hub assembly 436. In some embodiments, the hub assembly 436 has other configurations that allow the connectors 205 to be selectively disengaged in a different manner or sequence, eg, the connectors 205 on the front side are released before the connectors 205 on the rear side.

In some embodiments, in the second position, detent 558 inhibits further distal movement of inner hub member 540 (eg, to the third position shown in FIGS. 5C and 5F ). For example, release shaft 562 may bias flared portion 559 of lock pin 558 radially outward and engage stop surface 560 of outer hub member 542 , while stop member 561 engages stop surface 554 of lock cavity 564 . In some aspects of the present technology, locking pin 558 and release shaft 562 inhibit or even prevent inadvertent deployment of strut 206 at anterior portion A of atrial fixation member 202 by preventing first recess 544 from moving distally beyond distal opening 549 of outer hub member 542 (e.g., to the third position shown in FIGS. 5C and 5F ).

To move the hub assembly 436 to the third position shown in FIGS. 5C and 5F , the user can first remove the release shaft 562 from the release cavity 563 of the lock pin 558 by proximally moving (eg, pulling) the release member 685 away from the gear assembly 680 of the hub shaft handle 326 . The user may then further actuate ring gear 684 of hub shaft handle 326 to drive drive shaft 552 in rotation. Removing the release shaft 562 removes the outward biasing force provided by the release shaft 562 when the flared portion 559 is pushed inward, thereby allowing the flared portion 559 of the lock pin 558 to move (e.g., bend) radially inwardly and beyond the stop surface 560 of the outer hub member 542 as the drive shaft 552 and lead screw 555 drive the inner hub member 540 distally. In the third position, the first recess 544 (e.g., the second portion 547 of the first recess 544) is located far enough from the distal opening 549 of the outer hub member 542 that the connector 205 located on the anterior portion A of the implantable device 200 is no longer constrained by the outer hub member 542 and is thus free to disengage from the hub assembly 436. Thus, moving the hub assembly 436 to the third position disengages the struts 206 at the anterior portion A of the atrial fixation member 202 from the hub assembly 436, allowing them to expand. Accordingly, in some aspects of the present technology, the hub assembly 436 is configured to provide a controlled two-stage release of the atrial fixation member 202, wherein the struts 206 at the posterior portion P are released from the hub assembly 436 and allowed to expand prior to the struts 206 at the anterior portion A. In an additional aspect of the present technology, the hub assembly 436 allows for controlled and staged release of the atrial fixation member 202 from the distal end of the delivery system 310 ( FIG. 3 ), and is independent or minimally affected by factors such as catheter shaft compression, bending, etc., which may make it difficult to control the release of the atrial fixation member 202 with the same precision through control from the proximal end of the delivery system 310.

7A and 7B are partially transparent isometric side views and enlarged partial cross-sectional side views, respectively, of plug assembly 438 at the distal portion of delivery system 310 of FIGS. 3 and 4 in accordance with embodiments of the present technology. Referring to FIGS. 7A and 7B together, the plug assembly 438 includes a plug housing 790 configured to be secured to/at the distal end of the mandrel 318 . Plug housing 790 includes a proximal portion 791a and a distal portion 791b. In some embodiments, a portion of the plug housing 790 extends at least partially into the cavity 792 defined by the mandrel 318 and may be secured thereto by a friction-fit arrangement, adhesives, laser welding, fasteners, and/or other suitable attachment mechanisms.

The plug assembly 438 further includes/defined a plurality of lumens, including a drive lumen 793, a clamp lumen 794, and a tie lumen 795 (collectively "lumens 793-795"). In the illustrated embodiment, lumens 793 - 795 are defined by a tube coupled to plug housing 790 and extending distally into lumen 792 of mandrel 318 . In some embodiments, the tube is a short flexible tube, while in other embodiments the tube may be rigid or semi-rigid and/or may extend the entire length of the mandrel 318 . In other embodiments, cavities 793 - 795 may be defined separately within plug housing 790 and/or may extend through the wall of mandrel 318 . For example, the plug housing 790 may be a single piece, such as a plastic extrusion, that defines each of the cavities 793-795.

Clip tendon cavity 794 is configured to receive a first elongate flexible member, such as a suture, string, and/or wire (e.g., clip tendon 821 shown in FIG. 8C ), for actuating clip 209 of septum 204 ( FIGS. 2A and 2B ), as described in more detail below. Bound tendon lumen 795 extends distally to flexible tube 437 and is configured to receive a second elongate flexible member, such as tie tendon 439 ( FIG. 4 ), for controlling expansion and contraction of atrial fixation member 202 . In some embodiments, one or two in the first and second extension flexible components (eg, clip and bundle tight tendon) can extend from the proximal part of the delivery system 310 (Figure 3) to the remote part, where they form the ring that revolves around components (for example, clip 209 (Figure 2A) and/or atrium fixed component 202 (Figure 2A and 2B)), and then pass through The delivery system 310 extends up to the proximal (for example, called "double -length suture ring"). In these embodiments, the clamping tendon cavity 794 and/or the tying tendon cavity 795 carry the two sections of the elongated flexible member, and in certain embodiments, the tube carrying the flexible member divides the cavities 794, 795 into separate channels that carry the separate sections of the elongated flexible member to avoid entanglement or excessive friction.

In the illustrated embodiment, the bung assembly 438 includes a septum connection member 796, such as a threaded shaft (e.g., a screw), that is secured to the bung housing 790 in a distal portion of a drive lumen 793 and that extends out of the drive lumen 793 beyond a distal portion 791b of the bung housing 790. In some embodiments, diaphragm connection member 796 is rotatably coupled within drive cavity 793 . With additional reference to FIG. 4 , septum connection member 796 is configured to extend through opening 201 in septum 204 to releasably engage delivery attachment member 203 (eg, by threading) to secure mandrel 318 to septum 204 of implantable device 200 . Drive shaft 798 can extend through drive lumen 793 to operably couple septum connection member 796 to an actuation device (e.g., a wheel, knob, button) of the proximal portion of delivery system 310 ( FIG. 3 ), which can be actuated to impart rotation on septum connection member 796 to disengage septum connection member 796 from delivery attachment member 203. The drive shaft 798 may be coupled to the bulkhead connection member 796 by welding, adhesives, fasteners, and/or other suitable types of connections, or be made from a single wire.

The clamp tendon, tie tendon 439 , and drive shaft 798 extend from the bung assembly 438 , through the mandrel 318 , and to the mandrel handle 328 . 8A-8D are respectively a distal-facing isometric view, a partially transparent side view, a partially transparent top view, and a partially transparent proximal-facing isometric view of a mandrel handle 328 configured in accordance with embodiments of the present technology. In general, the mandrel handle 328 is configured to be manipulated/actuated by the user to individually actuate (i) the clip tendon to open/close the clip 209 (FIGS. 2A and 2B), (ii) drive the shaft 798 to unscrew the septum connection member 796 (FIGS. 7A and 7B) from the septum 204 (FIGS. 2A and 2B), and (iii) tighten the tendon 439 to tighten/loosen the atrial fixation member 202 (FIGS. 2A and 2B).

Referring to FIGS. 8A-8D together, the mandrel handle 328 includes a mandrel housing 802 and a plurality of actuators coupled to the mandrel housing 802 including, for example, a diaphragm actuator 804 , a clip actuator 806 , and a tightening actuator 808 . Housing 802 is shown partially transparent in Figures 8B-8D. Housing 802 and/or other components of mandrel handle 328 define a series of interconnected lumens, including mandrel lumen 812, valve lumen 814, and actuation lumen 816 (collectively "lumens 812-816"). The mandrel handle 328 also includes a mandrel connection 818 between the cavities 812-816. Mandrel 318 is configured to extend through mandrel cavity 812 and is secured to mandrel connection 818 . Valve lumen 814 is configured to receive valve 819 and/or one or more additional adapters, valves, sealing members, and/or other fluid control components for, e.g., maintaining hemostasis, facilitating fluid (e.g., blood, priming solution, saline) in and out of mandrel 318, etc. Rail 332 may be secured to housing 802 and/or other components of spindle handle 328 to slidably couple spindle handle 328 to hub spindle handle 326 ( FIG. 3 ).

Drive shaft 798 may extend through mandrel 318 , mandrel connection 818 , and into actuation cavity 816 where it is secured to diaphragm actuator 804 . The diaphragm actuator 804 is accessible by the user through the housing 802 at the proximal portion of the mandrel handle 328 and can be actuated to drive the drive shaft 798 . For example, in the illustrated embodiment, diaphragm actuator 804 may be rotated to rotate drive shaft 798 . Thus, with additional reference to FIGS. 4, 7A, and 7B, a user (e.g., a physician) can grasp and rotate the septum actuator 804 to impart rotation to the drive shaft 798, which in turn rotates the septum connection member 796 to disengage the septum connection member 796 from the delivery attachment member 203, and thereby disengage/detach the septum 204 from the mandrel 318.

In the illustrated embodiment, the mandrel handle 328 includes a clip mount assembly 820 and a tie mount assembly 830 slidably disposed within the actuation cavity 816 . Clip mount assembly 820 is operatively coupled to clip actuator 806 and cinch mount assembly 830 is operably coupled to cinch actuator 808 . 8E-8H are a partially transparent side view, a proximally facing front view, a distally facing isometric view, and another distally facing isometric view, respectively, of a clip mount assembly 820 and a tightening mount assembly 830 configured in accordance with embodiments of the present technology. The tension mount assembly 830 is in (i) the relaxed (eg, first, no tension, minimal tension) configuration in FIGS. 8E and 8G and (ii) the tensed (eg, second) configuration in FIGS. 8F and 8H .

Referring to FIGS. 8E-8H together, the clip mount assembly 820 can include a body 822, a clip tendon mount 824 secured to the body 822, and a latch 840 movably (eg, pivotally) coupled to the body 822 (eg, via a shaft 842). For clarity, latch 840 is omitted from FIG. 8H. Clip actuator 806 may be connected to latch 840 and slidably mounted to a first slot 803 extending through/along housing 802 ( FIGS. 8A-8D ). With additional reference to FIG. 8C , a clip tendon (eg, clip tendon 821 shown in FIG. 8C ) extends through mandrel 318 , mandrel connector 818 , and into actuation cavity 816 where it is releasably coupled to clip tendon mount 824 . In the illustrated embodiment, for example, clip tendon mount 824 includes posts 841 and screws 843 . Clip tendon 821 may be a double length loop of suture wrapped around post 841 (eg, once, twice, ten times, more than ten times) and then secured to body 822 via screws 843 . As best shown in FIGS. 8E and 8H , the latch 840 can include a plurality of first engagement features 845 (eg, teeth, slots) and can be operatively coupled to the body 822 via a biasing member 846 (eg, as a compression spring). As best shown in FIGS. 8A and 8B , housing 802 may include a plurality of second mating features 847 (eg, teeth, slots) positioned within actuation cavity 816 adjacent first slot 803 . Referring to FIGS. 8A , 8B, 8E, and 8H together, biasing member 846 may generally bias first mating feature 845 into cooperation with second mating feature 847 to inhibit movement of clip actuator 806 and clip mounting assembly 820 along first slot 803 . To move clip mounting assembly 820 through actuation cavity 816, a user may depress clip actuator 806 against the biasing force of biasing member 846 to disengage first mating feature 845 from second mating feature 847, and then slide clip actuator 806 along first slot 803.

Referring again to FIGS. 8A-8D together, during delivery, actuation of clip actuator 806 may drive clip mounting assembly 820 within actuation chamber 816 to drive/tension clip tendon 821 to open/close clip 209 ( FIG. 2B ). More specifically, FIGS. 8A-8D show the clip actuator 806 in a first position, where the clip actuator 806 is located near the distal end of the first slot 803 . In operation, a user may depress clip actuator 806 and slide clip actuator 806 along first slot 803 toward a second position near a proximal portion of first slot 803 (eg, in the direction indicated by arrow P in FIG. 8A ). This proximal movement of clip actuator 806 can pull on clip tendon 821 to open clip 209 . Likewise, distal movement of the clip actuator 806 can release the force/tension on the clip tendon 821, allowing the normally closed clip 209 to close. In some embodiments, the length of the first slot 803 may be selected to correspond to a particular opening/closing stroke of the clip 209 . For example, the position of the distal portion of first slot 803 may be selected to correspond to the fully-closed position of clip 209 and/or the position of the proximal portion of first slot 803 may be selected to correspond to the fully-open position of clip 209 . In other embodiments, the mandrel handle 328 may include other features for actuating the clip tendon 821 to open/close the clip 209, such as one or more buttons, levers, knobs, sliders, and/or other actuation members.

Referring again to FIGS. 8E-8H together, the strap mount assembly 830 can include a body 832, a tendon mount 834 (shown partially transparently in FIG. 8E for clarity) and a biasing member 836 ( FIG. 8E ) that operably couples the tendon mount 834 to the body 832. In the illustrated embodiment, the body defines a channel 850 and the tendon mount 834 is slidably mounted within the channel 850 . With additional reference to FIG. 8C , the tying tendon 439 ( FIG. 8C ) extends through the mandrel 318 , the mandrel connector 818 , and into the actuation cavity 816 where it is coupled to the tying tendon mount 834 . In the illustrated embodiment, for example, the tendon mount 824 includes a post 851 and a screw 853 (both not visible in FIGS. 8E and 8H ) over which the tendon 439 can be wrapped and further secured (e.g., clamped) by the screw 853.

Referring again to FIGS. 8A-8D together, the tightening actuator 808 may be a ring gear that is accessible by the user from the housing 802 for actuation. Cinch actuator 808 may be operably coupled to cinch mount assembly 830 via pinion gear 835 and lead screw 837 . More specifically, pinion 835 may be coupled to cinch actuator 808 by, for example, mating a plurality of teeth of pinion 835 and cinch actuator 808 . Pinion gear 835 may be fixedly mounted to lead screw 837, which may threadably engage tie-down mounting assembly 830 (eg, body 832). Thus, with additional reference to FIG. 4 , a user can grasp and rotate tightening actuator 808 to (i) drive lead screw 837 to rotate, (ii) drive tightening mount assembly 830 to move (e.g., translate) within actuator lumen 816, and (iii) drive/tension tightening tendon 439 to tighten/loosen atrial fixation member 202 of implantable device 200 ( FIGS. 2A and 2B ). For example, the tightening mount assembly 830 is in a first position in FIGS. 8A-8D , wherein the tightening mount assembly 830 is positioned proximate to the distal portion of the actuation lumen 816 . In operation, rotation of cinch actuator 808 in a first direction may drive cinch mount assembly 830 proximally through actuation lumen 816 to draw cinch tendon 439 proximally to radially compress atrial fixation member 202 . Conversely, rotation of the cinch actuator 808 in the second direction can drive the cinch mount assembly 830 distally through the actuation lumen 816 to loosen the cinch tendon 439 to allow radial expansion of the atrial fixation member 202 .

Referring collectively to FIGS. 8A-8H , in some embodiments, biasing member 836 stores energy (eg, changes to a "loaded" state) as cinch mount assembly 830 is driven proximally through actuation lumen 816 . In some embodiments, biasing member 836 may be a compression spring that compresses due to the reaction force between body 832 (eg, via lead screw 837 ) and lacing tendon mount 834 (eg, via lacing tendon 439 ). In the illustrated embodiment, the lacing tendon mount 834 includes a lacing indicator portion 810 that can be viewed through, for example, a second slot 809 extending through/along the housing 802 . The distance between the tightening indicator portion 810 and the main body 832 of the tightening tendon mount 834 indicates the relative amount of tightening. For example, in the relaxed position shown in FIGS. 8E and 8G , biasing member 836 may bias lacing tendon mount 834 away from body 832—increasing the distance between lacing indicator portion 810 and body 832 . Conversely, in the tensioned position shown in FIGS. 8F and 8H , the tightening force may compress the biasing member 836 —decreasing the distance between the tightening indicator portion 810 and the body 832 . Thus, a user can observe the positional setting of the tightening indicator portion 810 along the second slot 809 to determine the amount of tightening.

In other aspects of the present technology, biasing member 836 of cinch mount assembly 830 is configured to spring-load cinch tendon 439 such that tension is maintained on cinch tendon 439 during manipulation of delivery system 310 . With additional reference to FIGS. 2A and 2B , this can inhibit or even prevent undesired tightening/loosening of the atrial fixation member 202 . In some embodiments, eg, actuating tightening actuator 808 to tighten implantable device 200 , biasing member 836 may be loaded such that biasing member 836 may remove any slack in tightening tendon 439 during manipulation of delivery system 310 . In other embodiments, the mandrel handle 328 may include other features for actuating the tightening tendon 439 to tighten/loosen the implantable device 200, such as one or more buttons, levers, knobs, sliders, and/or other actuators. For example, in some embodiments, cinch tendon 439 may be actuated by the same or similar arrangement as clip tendon 821 (eg, by sliding movement of cinch actuator 808 along housing 802 ).

In some embodiments, the clip tendon mount 824 of the clip mount assembly 820 and the lacing tendon mount 834 of the lacing mount assembly 830 are each approximately aligned with the longitudinal axis/centerline of the mandrel handle 328 . This arrangement can help ensure relative alignment of tension/driving forces on the tying tendons 439 and clip tendons 821 (collectively "tendons 439, 821") along the axis of the tendons 439, 821 and help inhibit shear or other forces that could prematurely damage the tendons 439, 821. In some aspects of the present technology, clip mount assembly 820 and tie mount assembly 830 are independently movable through actuation cavity 816 . For example, in the illustrated embodiment, the body 822 of the clip mount assembly 820 and the body 832 of the tie mount assembly 830 each have complementary shapes (e.g., generally L-shaped) that allow the clip and tie mount assemblies 820, 830 to move through the actuation cavity 816 without interfering with each other. In other embodiments, the clip and tie mount assemblies 820, 830 may be operably coupled to move together.

Referring to FIG. 8C , the housing 802 can also include an opening 805 configured (eg, shaped, sized, and/or positioned) to provide access to the tendons 439 , 821 . For example, in operation, a user may remove tendon 439 , 821 by (i) inserting a cutting tool through opening 805 to cut tendon 439 , 821 and (ii) pulling tendon 439 , 821 out of opening 805 . In other embodiments, the mandrel handle 328 may have other features for cutting and/or removing tendons 439,821. In some embodiments, the housing 802 further includes a removable cover 807 that may be releasably secured over the opening 805 (eg, via a snap-fit arrangement) to hide the tendons 439 , 821 and enclose the internal features of the mandrel handle 328 .

14A-14D are respectively a distally-facing isometric view, a partially transparent side view, a partially transparent enlarged side view, and a partially transparent proximally-facing isometric view of a mandrel handle 1428 configured in accordance with additional embodiments of the present technology. The mandrel handle 1428 may (i) include several features generally similar or identical to the mandrel handle 328 described in detail above with reference to FIGS. Referring to FIGS. 14A-14D together, the mandrel handle 1428 includes a mandrel housing 1402 and a plurality of actuators coupled to the mandrel housing 1402 including, for example, a baffle actuator 1404 , a clip actuator 1406 , and a tightening actuator 1408 . Housing 1402 and/or other components of mandrel handle 1428 define a series of interconnected lumens, including mandrel lumen 1412, valve lumen 1414, and actuation lumen 1416 (collectively "lumens 1412-1416"). As best shown in FIG. 14B, the mandrel handle 1428 also includes a mandrel connection 1418 between the cavities 1412-1416. Mandrel 318 ( FIG. 3 ; not shown in FIGS. 14A-8D for clarity) is configured to extend through mandrel cavity 1412 and to be secured to mandrel connection 1418 . Valve lumen 1414 is configured to receive one or more adapters, valves, sealing members, and/or other fluid control components (not shown) for, for example, maintaining hemostasis, facilitating ingress/egress of fluid (e.g., blood, priming solution, saline) into mandrel 318, etc. As best shown in FIGS. 14A and 14B , rails 332 may be secured to housing 1402 and/or other components of spindle handle 1428 to slidably couple spindle handle 1428 to hub spindle handle 326 .

Drive shaft 798 may extend through mandrel 318 , mandrel connection 1418 , and into actuation cavity 1416 where it is secured to diaphragm actuator 1404 . The diaphragm actuator 1404 is accessible by the user through the housing 1402 at the proximal portion of the mandrel handle 1428 and is actuatable to drive the drive shaft 798 . For example, in the illustrated embodiment, diaphragm actuator 1404 may rotate to rotate drive shaft 798 . Thus, with additional reference to FIGS. 4 , 7A, and 7B , a user (e.g., a physician) can grasp and rotate the septum actuator 1404 to impart rotation to the drive shaft 798, which in turn rotates the septum connection member 796 to disengage the septum connection member 796 from the delivery attachment member 203, and thereby disengage/detach the septum 204 from the mandrel 318.

In the illustrated embodiment, the mandrel handle 1428 includes a location for the clip mounting assembly 1420 slidably disposed within the actuation cavity 1416 . A clip tendon (eg, clip tendon 1421 shown in FIG. 14C ) extends through mandrel 318 , mandrel connector 1418 , and into actuation cavity 1416 where it is releasably coupled to clip mount assembly 1420 . In some embodiments, clip mount assembly 1420 includes a body 1422 , a clip tendon mount 1424 , and a biasing member 1426 that operably couples clip tendon mount 1424 to body 1422 . For clarity, body 1422 is shown partially transparent in Figures 14B and 14D. Clip actuator 1406 may be slidably mounted to first slot 1403 extending through/along housing 1402 and operably coupled to clip mounting assembly 1420 through first slot 1403 . In the illustrated embodiment, the clip tendon 1421 is a double-length suture loop that extends through an eyelet 1423 in the clip tendon mount 1424 .

During the delivery procedure, actuation of the clip actuator 1406 can drive the clip mounting assembly 1420 within the actuation chamber 1416 to drive/tension the clip tendon 1421 to open/close the clip 209 (FIG. 2B). More specifically, FIGS. 14A-14D show the clip actuator 1406 in a first position, wherein the clip actuator 1406 is located near the distal portion of the first slot 1403 . In operation, a user may grasp clip actuator 1406 and slide clip actuator 1406 along first slot 1403 toward a second position near a proximal portion of first slot 1403 (eg, in the direction indicated by arrow P in FIG. 14A ). This proximal movement of the clip actuator 1406 can pull the clip tendon 1421 to open the clip 209 . Likewise, distal movement of the clip actuator 1406 can release the force/tension on the clip tendon 1421, allowing the normally closed clip 209 to close. In some embodiments, the length of the first slot 1403 may be selected to correspond to a particular opening/closing stroke of the clip 209 . For example, the position of the distal portion of the first slot 1403 may be selected to correspond to the fully-closed position of the clip 209 and/or the position of the proximal portion of the first slot 1403 may be selected to correspond to the fully-open position of the clip 209. In some embodiments, biasing member 1426 stores energy (eg, becomes a "loaded" state) as clip mounting assembly 1420 is driven proximally through actuation lumen 1416 . In various embodiments, the mandrel handle 1428 may include other features for actuating the clip tendon 1421 to open/close the clip 209, such as one or more buttons, levers, knobs, sliders, and/or other actuation components.

As further shown in FIGS. 14B-14D , the mandrel handle 1428 may also include a tie-down mount assembly 1430 slidably disposed within the actuation cavity 1416 . Strain mount assembly 1430 may include substantially similar or identical features to those of clip mount assembly 1420 . For example, in the illustrated embodiment, the cinch mount assembly 1430 includes a main body 1432 (shown partially transparent in FIGS. Tendon 439 extends through mandrel 318 , mandrel connector 1418 , and into actuation cavity 1416 where it is coupled to tendon mount 1434 through an eyelet 1433 formed therein.

In some embodiments, as best shown in FIG. 14D , cinch actuator 1408 is a ring gear that is accessible by the user from housing 1402 for actuation. Cinch actuator 1408 may be operatively coupled to cinch mount assembly 1430 via pinion gear 1435 and lead screw 1437 . More specifically, the pinion gear 1435 can be coupled to the cinch actuator 1408 , such as by mating a plurality of teeth of the pinion gear 1435 and the cinch actuator 1408 . Pinion gear 1435 may be fixedly mounted to lead screw 1437, which may threadably engage tie-down mounting assembly 1430 (eg, body 1432). Thus, with additional reference to FIG. 4 , the user can grasp and rotate the tightening actuator 1408 to (i) drive the lead screw 1437 to rotate, (ii) drive the tightening mount assembly 1430 to move (e.g., translate) within the actuator lumen 1416, and (iii) drive/tension the tightening tendon 439 to tighten/loosen the atrial fixation member 202 of the implantable device 200. For example, the tightening mount assembly 1430 is in a first position in FIGS. 14A-14D , wherein the tightening mount assembly 1430 is positioned adjacent a distal portion of the actuation lumen 1416 . In operation, rotation of cinch actuator 1408 in a first direction may drive cinch mount assembly 1430 proximally through actuation lumen 1416 to pull cinch tendon 439 proximally to radially compress atrial fixation member 202 ( FIGS. 2A and 2B ). Conversely, rotation of the cinch actuator 1408 in the second direction can drive the cinch mount assembly 1430 distally through the actuator lumen 1416 to loosen the cinch tendon 439 to allow radial expansion of the atrial fixation member 202 . In some embodiments, the biasing member 1436 stores energy (eg, changes to a "loaded" state) when the tightening mount assembly 1430 is driven proximally through the actuation lumen 1416 .

In various embodiments, the mandrel handle 1428 may include other features for actuating the lacing tendons 439 to tighten/loosen the implantable device 200, such as one or more buttons, levers, knobs, sliders, and/or other actuators. For example, in some embodiments, cinch tendon 439 may be actuated by the same or similar arrangement as clip tendon 1421 (eg, by sliding movement of cinch actuator 1408 along housing 1402 ).

In some aspects of the present technology, clip mount assembly 1420 and tie mount assembly 1430 are independently movable through actuation cavity 1416 . For example, in the illustrated embodiment, the body 1422 of the clip mount assembly 1420 and the body 1432 of the tie mount assembly 1430 each have a complementary shape (e.g., a semicircular cross-sectional shape) that allows the clip and tie mount assemblies 1420, 1430 to move through the actuation cavity 1416 without interfering with each other. In other embodiments, the clip and tie mount assemblies 1420, 1430 may be operably coupled to move together.

In another aspect of the present technology, the biasing member 1426 of the clip mount assembly 1420 and the biasing member 1436 of the tightening mount assembly 1430 are configured to spring load the clip tendon 1421 and the tightening tendon 439 (collectively "tendons 439, 1421") such that tension is maintained on the tendons during operation of the delivery system 310. With additional reference to FIGS. 2A and 2B , this may inhibit or even prevent undesired actuation of the clip 209 or tightening/loosening of the atrial fixation member 202 . For example, in some embodiments, actuating the tightening actuator 1408 to tighten the implantable device 200 may load the biasing member 1436 such that the biasing member 1436 can absorb any slack in the tightening tendon 439 during operation of the delivery system 310 . In another aspect of the present technology, the clip tendon mount 1424 of the tightening mount assembly 1420 and the tightening tendon mount 1434 of the tightening mount assembly 1430 are each approximately aligned with the longitudinal axis/centerline of the mandrel handle 1428 . This arrangement can help ensure that the tension/drive forces on the tendon 439, 1421 are relatively aligned along the axis of the tendon 439, 1421 and help dampen shear or other forces that could prematurely damage the tendon 439, 1421.

Referring to FIGS. 14B and 14D together, the housing 1402 may also include an opening 1405 configured (eg, shaped, sized, and/or positioned) to provide access to the tendons 439 , 1421 . For example, in operation, a user may remove tendon 439 , 1421 by (i) cutting tendon 439 , 1421 by inserting a cutting tool through opening 1405 , and (ii) pulling tendon 439 , 1421 out of opening 1405 . In other embodiments, the mandrel handle 1428 may have other features for cutting/removing tendons 439 , 1421 . In some embodiments, housing 1402 further includes a removable cover 1407 ( FIGS. 14A , 14C, and 14D ) that is releasably secured over opening 1405 (e.g., via a snap-fit arrangement) to conceal tendons 439, 1421 and enclose internal features of mandrel handle 1428.

In the illustrated embodiment, the tightening indicator 1410 is coupled to the tightening mount assembly 1430 and extends at least partially out of a second slot 1409 extending through/along the housing 1402 . For example, the tightening indicator 1410 may be coupled to the main body 1432 of the tightening mount assembly 1430 by threaded fasteners or other suitable fasteners. In operation, the tightening indicator 1410 moves along the second slot 1409 as the tightening actuator 1408 drives the tightening mount assembly 1430 to move through the actuation cavity 1416 . A user may observe the position of the tightening indicator 1410 along the second slot 1409 to determine an amount of tightening. In some embodiments, the length of the second slot 1409 can be selected to provide a maximum/minimum amount of tightening of the atrial fixation member 202 . For example, the location of the distal portion of the second slot 1409 can be selected to correspond to a minimum amount of tightening, and/or the location of the proximal portion of the second slot 1409 can be selected to correspond to a maximum amount of tightening. In some embodiments, the tightening indicator 1410 can inhibit or even prevent the rotation of the tightening mount assembly 1430 within the actuation cavity 1416 .

3-8H and 13A-14D together, the various components of the delivery system 310 can be formed from metal (eg, stainless steel, nitinol, etc.), plastic, and/or other suitable materials. Various components may be fabricated using three-dimensional printing, injection molding, machining, and/or other suitable processes known in the art. Furthermore, various actuation means may be combined or changed without departing from the scope of the present technology.

III. Selected Embodiments of Methods of Delivering Implantable Devices

9 is a flowchart of a process or method 940 for operating delivery system 310 ( FIGS. 3A-8D , 13A, and 13B ) to implant implantable device 200 ( FIGS. 2A , 2B, and 4 ) at a target site in a patient (e.g., at a native mitral valve in a human patient) in accordance with an embodiment of the present technology. 10A-10I are side views illustrating the distal portion of implantable device 200 and delivery system 310 during various stages of method 940 in accordance with embodiments of the present technology. Although some features of the method 940 are described for purposes of illustration in the context of the embodiment shown in FIGS. 2A-8H , 13A, and 13B, those skilled in the art will readily appreciate that the method 900 can be performed using other suitable systems and/or devices described herein (e.g., including the mandrel handle 1428 described in detail with reference to FIGS. 14A-14D ). Likewise, while method 940 is described in the context of delivering an implantable device to a native mitral valve, method 940 may be used to deliver implantable devices to other locations in a patient (eg, to other heart valves).

At block 941 , method 940 includes positioning guide catheter 312 proximate the left atrium of the patient. For example, referring to FIG. 10A , a guide catheter 312 may be inserted through the venous system (e.g., via a femoral or axillary approach) to the right atrium, and then via a trans-septal approach through the interatrial septum S into the left atrium LA (or via a trans-atrial approach through the atrial roof). In some embodiments, the distal portion of the guide catheter 312 may be positioned such that its most distal end (eg, the end farthest from the user) is in the left atrium LA. For example, guide catheter 312 can be extended to a position as shown in FIG. 10A , or guide catheter 312 can be positioned further in the left atrium LA to extend at least generally along the flow axis of the native heart valve (e.g., the generally vertical axis VA in FIG. 10A ). This alignment may be achieved by a combination of twisting/directing the guide catheter 312 using the guide catheter handle 322 , pre-shaping the end of the guide catheter 312 , and/or bending the guide catheter 312 . However, in some embodiments, guide catheter 312 may not have such full steerability, and its distal tip may be positioned more closely such that delivery catheter 314, hub 316, and/or mandrel 318 (positioned within guide catheter 312) may provide additional placement at desired locations across septum S.

At block 942, method 940 continues by advancing delivery catheter 314 (including implantable device 200 compressed therein), hub shaft 316, and mandrel 318 through guide catheter 312 into left atrium LA, as shown in FIG. 10B . Once the position is set within the left atrium LA, the method 940 includes unsheathing the implantable device 200 from the delivery catheter 314 (block 943). For example, FIG. 10C shows implantable device 200 after at least partial unsheathing, which allows atrial fixation member 202 and septum 204 to at least partially expand in left atrium LA. Implantable device 200 may be unsheathed by retracting delivery catheter 314 proximally relative to implantable device 200 . In other embodiments, implantable device 200 may be unsheathed by advancing implantable device 200 distally relative to delivery catheter 314 (e.g., by advancing hub shaft 316 and mandrel 318 relative to delivery catheter 314), in addition to or instead of retracting delivery catheter 314.

At block 944 , method 940 includes longitudinally/axially compressing (eg, flattening, shortening) implantable device 200 . For example, Figure 10D shows implantable device 200 after being compressed. Longitudinally compressing the implantable device 200 includes reducing (i) the upper end portion S and the lower end portion I and (ii) the distance between the plug assembly 438 and the mandrel 318 . To compress implantable device 200 longitudinally, a user may move hub shaft 316 and/or mandrel 318 relative to each other to shorten the distance between hub assembly 436 of hub shaft 316 and plug assembly 438 of mandrel 318 . For example, a user may move hub shaft handle 326 and/or mandrel handle 328 toward each other along support assembly 320 . In one aspect of the present technology, longitudinally compressing the implantable device 200 makes it easier to rotate, translate, and/or position the implantable device 200 within the spatial constraints of the left atrium LA. In some embodiments, the implantable device 200 is axially compressed relative to its length by more than about 20%, more than about 50%, or more than about 70% while compressed in the delivery catheter (block 942) and/or after being unsheathed in the left atrium LA (block 943). In other embodiments, block 943 may be omitted and implantable device 200 need not be compressed longitudinally.

At block 945 , method 940 may include advancing delivery catheter 314 distally toward implantable device 200 such that delivery catheter 314 is positioned adjacent/above hub assembly 436 constraining strut 206 to upper end portion S of implantable device 200 . More specifically, the location of the distal portion of the delivery catheter 314 can be positioned on the hub assembly 436 and the compressed atrial fixation member 202 can at least partially surround the distal portion of the delivery catheter 314 . In some aspects of the present technology, positioning the delivery catheter 314 at least partially on the implantable device 200 can help control the orientation of the implantable device 200 within the left atrium LA by providing the implantable device 200 with additional stiffness, pushability, and/or twistability.

At block 946, the method 940 includes directing the implantable device 200 toward the patient's mitral valve such that the lower end portion I of the implantable device 200 is directed toward the mitral valve annulus, and aligning the implantable device 200 with a portion of the one or more desired native leaflets. For example, FIGS. 10E and 10F show the implantable device 200 during and after steering orientation, respectively, towards the mitral valve MV and aligning the implantable device 200 with the native leaflets of the mitral valve MV (e.g., the middle sector P2 of the posterior leaflet). In some embodiments, spine 378 of delivery catheter 314 may help facilitate controlled orientation of implantable device 200 toward mitral valve MV, even within the relatively small space of left atrium LA.

At block 947, after the implantable device 200 is rotationally and radially aligned with the desired portion of the leaflet, the method 940 includes advancing the implantable device 200 at least partially through the mitral valve MV and capturing the desired portion of the leaflet. For example, the direction of implantable device 200 may be steered to the target site such that implantable device 200 passes through the mitral valve annulus with atrial fixation member 202 positioned at least partially above the annulus in left atrium LA and engagement member 204 positioned at or below the annulus in left ventricle LV. 10G and 10H show implantable device 200 during and after capture of medial sector P2 of the posterior leaflet with clip 209 . In some embodiments, the clip 209 may be opened before or after passage through the mitral valve MV, as shown in FIG. 10G , and then closed to capture the medial sector P2 of the posterior leaflet between the clip 209 and the septum 204 . As described in detail above with reference to FIGS. 2A , 2B and 8A-8D , the user may open and close the clips 209 by actuating (eg, depressing and then sliding) the clip actuator 806 of the mandrel handle 328 . In some embodiments, clip 209 may be opened to assist in orienting implantable device 200 in left atrium LA.

In general, to control the orientation of implantable device 200 to capture the desired native leaflet (blocks 946 and 947), the user may manipulate one or more of handles 322-328. For example, a user may manipulate guide catheter handle 322 and/or delivery catheter handle 324 to advance and/or deflect guide catheter 312 and/or delivery catheter 314 in one or more directions, such as in a direction toward the mitral valve MV—to facilitate placement of implantable device 200. In some embodiments, re-advancement of delivery catheter 314 toward implantable device 200, as shown in Figure 10E, facilitates position setting/orientation control of the implantable device through manipulation of delivery catheter 314. Additionally, implantable device 200 can be oriented as desired by, for example, rotating hub shaft handle 326 and mandrel handle 328 together relative to delivery catheter 314 . For example, with additional reference to FIG. 3 , the hub shaft handle 326 and the mandrel handle 328 may rotate together about the second mount 327 b and the third mount 327 c , respectively. In some embodiments, because hub shaft handle 326 and mandrel handle 328 are coupled together by track 332, rotation of one handle also rotates the other handle.

Once the implantable device 200 is properly positioned through the mitral valve MV with the engagement member 204 in place relative to the native leaflets, the method 940 continues at block 948 by releasing the atrial fixation member 202 allowing the atrial fixation member 202 to expand within the left atrium LA over the mitral valve MV. For example, FIG. 10H shows implantable device 200 after loosening of atrial fixation member 202 . The user may loosen the atrial fixation member 202 by rotating the tightening actuator 808 to release tension from the lacing tendon 439 . In some embodiments, the atrial fixation member 202 does not contact the wall of the left atrium LA after being released, or only a portion of the atrial fixation member 202 contacts tissue within the left atrium LA (eg, the posterior portion of the left atrium LA).

At block 949, the method 940 includes determining/assessing whether the implantable device 200 is properly positioned and functioning properly. The performance of implantable device 200, such as reduction in mitral regurgitant flow, may be assessed by transesophageal echocardiography ("TEE") imaging or another suitable technique.

At block 950, if the implantable device 200 is not functioning properly, the implantable device may be repositioned or retrieved and removed from the patient. For example, cinch actuator 808 may be actuated to radially compress atrial fixation member 202 . Then, the clip 209 can be opened to release the native leaflet by actuating (eg, sliding) the clip actuator 806 of the mandrel handle 328, and the implantable device 200 can be retracted into the left atrium LA. Implantable device 200 may then be repositioned or removed. Prior to removal, in some embodiments, implantable device 200 may be elongated along its longitudinal axis by moving hub shaft handle 326 and/or mandrel handle 328 to move hub shaft 316 and/or mandrel 318 relative to each other to extend the distance between hub assembly 436 of hub shaft 316 and plug assembly 438 of mandrel 318. Extending implantable device 200 further radially compresses implantable device 200 . Finally, implantable device 200 may be retracted into guide catheter 312 and removed from the patient.

If the clinician determines that the implantable device 200 is functioning properly, the method 940 may continue to block 951 where the implantable device 200 is fully released/detached from the delivery system 310 . More specifically, FIG. 11 is a flowchart illustrating a process or method 1160 for releasing an implantable device at block 951 in accordance with an embodiment of the present technology. 12A-12D are side views illustrating the distal portion of implantable device 200 and delivery system 310 during various stages of release method 1160 in accordance with an embodiment of the present technology.

At block 1161 , release method 1160 includes detaching separator 204 from delivery system 310 , and more specifically, mandrel 318 . Separating the septum 204 may include a septum actuator 804 that actuates the mandrel handle 328 to unscrew the septum connection member 796 from the delivery attachment member 203 located within the hollow interior of the septum 204 . In some embodiments, septum 204 may be separated from mandrel 318 prior to releasing implantable device 200 (block 948 of FIG. 9 ). In some embodiments, the tendons 439, 821 may be released (eg, cut through the opening 805 in the mandrel handle 328) prior to separating the septum 204.

At block 1162 , the releasing method 1160 includes releasing the first portion of the atrial fixation member 202 from the hub assembly 436 of the hub shaft 316 . For example, FIG. 12A illustrates implantable device 200 after release of connector 205 at posterior portion P of implantable device 200 . As described in detail above, the link 205 at the posterior portion P of the implantable device 200 can be released by actuating the ring gear 684 of the hub shaft handle 326 to drive the hub assembly 436 to the second position. As the first set of connectors 205 are released, the first portion of the atrial fixation member 202 (eg, the struts 206 near the posterior portion P) can further expand radially outward to contact and securely engage the wall of the left atrium LA.

At block 1163 , the releasing method 1160 includes releasing the second portion of the atrial fixation member 202 from the hub assembly 436 of the hub shaft 316 . For example, FIG. 12B shows implantable device 200 after connector 205 at anterior portion A of implantable device 200 has been released. As described in detail above, the connector 205 at the anterior portion A of the implantable device 200 can be released by (i) pulling the release member 685 of the hub shaft handle 326 to disengage the release shaft 562 from the lock pin 558, and then (ii) actuating the ring gear 684 of the hub shaft handle 326 to drive the hub assembly 436 to the third position. After release, a second portion of the atrial fixation member 202 (eg, the struts 206 near the anterior portion A) may contact and securely engage the wall of the left atrium LA. In some embodiments, the position and/or orientation of implantable device 200 may be manipulated after releasing the first portion of atrial fixation member 202 and before releasing the second portion of atrial fixation member 202 .

At block 1164, the releasing method 1160 includes removing the delivery system 310 from the patient. For example, catheters 312-314 may be withdrawn individually or collectively from the patient so that only implantable device 200 remains, as shown in Figure 12C.

2A-12C together, the delivery system 310 has several advantages that enable the delivery system 310 to reliably implant the implantable device 200 at the mitral valve MV to have the proper position and orientation. For example, delivery system 310 allows for individual control of atrial fixation member 202 and engagement member 204 and allows these components to be released from delivery system 310 individually. Additionally, delivery system 310 facilitates longitudinal compression of implantable device 200, allowing implantable device 200 to be navigated through the tight anatomy of left atrium LA. Additionally, hub assembly 436 allows atrial fixation member 202 to be released in two stages to facilitate proper engagement of atrial fixation member 202 with the wall of left atrium LA. Other advantages are described in detail throughout.

IV. Selected Additional Embodiments of Hub Assemblies

Figure 15 is an enlarged side view of a hub assembly 1536 configured in accordance with additional embodiments of the present technology. Hub assembly 1536 may (i) include several features substantially similar or identical to those of hub assembly 436 described in detail above with reference to FIGS. For example, with additional reference to FIGS. 2A and 2B , the hub assembly 1536 is configured to similarly receive and secure the connector 205 of the implantable device 200 and provide a controlled two-stage release of the atrial fixation member 202, wherein the struts 206 at the posterior portion P are released from the hub assembly 1536 and allowed to expand prior to the struts 206 at the anterior portion A (e.g., as shown in detail in FIGS. 12A and 12B ). For convenience, hub assembly 1536 is described herein with respect to the features of implantable device 200 of FIGS. 2A and 2B , although hub assembly 1536 may be used to hold and/or deploy other implantable devices.

More specifically, hub assembly 1536 can include inner hub member 1540 and outer hub member 1542 including distal opening 1549 . For clarity, outer hub component 1542 is shown partially transparent in FIG. 15 . Inner hub member 1540 may include (i) proximal or edge 1543a, (ii) distal or edge 1543b, (iii) a first recess extending proximally from distal edge 1543b configured to receive a corresponding connector 205 at anterior portion A of implantable device 200 ( FIGS. 2A and 2B ), and (iv) a second recess 1546 extending proximally from distal edge 1543b configured to receive A corresponding connector 205 at the posterior portion P of the implantable device 200 . In FIG. 15 , hub assembly 1536 is disposed in a first position where outer hub member 1542 is positioned to extend beyond respective first and second recesses 1544 , 1546 such that first and second recesses 1544 , 1556 are proximal to distal opening 1549 . Accordingly, when the hub assembly 1536 is in the first position, the connector 205 of the implantable device 200 is secured/contained within the first and second recesses 1544, 1546 by the outer hub assembly 1542.

Hub assembly 1536 may also include a lead screw 1555 and/or other drive member configured to translate inner hub assembly 1540 relative to outer hub assembly 1542, thereby moving hub assembly 1536 from a first position to a second position and from a second position to a third position (e.g., by actuating hub shaft handle 316 shown in FIGS. 6A-6C ). As described above in detail with reference to FIGS. 4-5F and 12A-12C , in the second position, at least a portion of each second recess 1546 can be positioned sufficiently far from the distal opening 1549 of the outer hub member 1542 that the connector 205 located at the posterior portion P of the implantable device 200 is no longer constrained by the outer hub member 1542 and thus can freely disengage from the hub assembly 1536 to partially deploy the implantable device 200. In the third position, at least a portion of each first recess 1544 can be positioned sufficiently distal to the distal opening 1549 so that the connector 205 at the anterior portion A of the implantable device 200 is no longer constrained by the outer hub member 1542 and thus can freely disengage from the hub assembly 1536 for further deployment of the implantable device 200. In some embodiments, hub assembly 1536 can also include detent 1558 configured to prevent further advancement of inner hub assembly 1542 from the second position to the third position.

In the illustrated embodiment, outer hub member 1542 has a distal edge 1503 including a stepped portion 1505 defining a cut-out area 1507 . Except for the cut-out region 1507, the outer hub member 1542 can have a generally cylindrical shape. Stepped portion 1505 and cut-out region 1507 can divide outer hub member 1542 into first portion 1504 located on and/or aligned over first recess 1544 , and second portion 1506 located on and/or aligned over second recess 1546 . First portion 1504 may have a side length L ₁ that is longer than side length L ₂ of second portion 1506 . When inner hub member 1540 is translated distally relative to outer hub member 1542 (e.g., to a second position), the shorter side length _L2 provided by cutout region 1507 causes second recess 1546 (and connector 205 therein) to extend out of distal opening 1549 and not be covered by outer hub member 1542 ahead of first recess 1544 (and connector 205 therein). Accordingly, different lengths _L1 and _L2 of outer hub component 1542 can facilitate staged release of atrial fixation member 202 while spanning a shorter overall axial length than a similar hub assembly of uniform length. In some aspects of the present technology, the shorter axial length can help improve directional control of hub assembly 1636 in tight anatomy and/or help facilitate faster deployment of implantable device 200, and/or (iii) enable.

In the illustrated embodiment, the length of second recess 1546 (eg, extending proximally from distal edge 1543b toward proximal edge 1543a ) is shorter than the length of first recess 1544 . Such an arrangement may further facilitate a two-stage release of the atrial fixation member 202, as described in detail above with reference to FIGS. 5A-6C and 12A-12C. In some embodiments, the stepped portion 1505 reduces the difference in length between the first recess 1544 and the second recess 1546 compared to the difference in length between the first recess 544 and the second recess 546 shown in FIGS. 5A-5C , while still providing the same deployment profile as the hub assembly 536 (e.g., with the same timing and actuation mechanism at the hub axle handle 326 shown in FIGS. 6A-6C ). In some embodiments, first recess 1544 and second recess 1546 can have the same or substantially similar size and dimensions (e.g., lengths) such that two-stage release of atrial fixation member 202 is facilitated only or substantially by different lengths _L and _L of outer hub portion 1542.

16A and 16B are enlarged side and front isometric views, respectively, of a hub assembly 1636 in accordance with additional embodiments of the present technology. Hub assembly 1636 may (i) include several features that are generally similar or identical to hub assembly 436 and/or hub assembly 1536 described in detail above with reference to FIGS. For example, with additional reference to FIGS. 2A and 2B , the hub assembly 1636 is configured to similarly receive and secure the connector 205 of the implantable device 200 and provide controlled, multi-stage release of the atrial fixation member 202, wherein the struts 206 at the posterior portion P are released from the hub assembly 1536 and allowed to expand prior to the struts 206 at the anterior portion A (e.g., as shown in detail in FIGS. 12A and 12B ). For convenience, hub assembly 1636 is described herein with respect to the features of implantable device 200 of FIGS. 2A and 2B , although hub assembly 1636 may be used to hold and/or deploy other implantable devices.

More specifically, referring to FIGS. 16A and 16B together, hub assembly 1636 can include inner hub member 1640 and outer hub member 1642 , outer hub member 1642 including distal opening 1649 . For clarity, the outer hub component 1642 is shown partially transparent in FIG. 16A and the inner hub assembly 1640 is shown partially transparent in FIG. 16B. Inner hub member 1640 may include (i) a proximal side or edge 1643a, (ii) a distal side or edge 1643b, (iii) and a plurality of recesses 1610 extending proximally from distal edge 1643b and configured to receive corresponding connectors 205. In some embodiments, each recess 1610 can have the same configuration (eg, size, shape, dimension). Outer hub member 1642 may include an opening 1612 (e.g., hole, slot) configured (e.g., sized, shaped, dimensioned) to position over a corresponding one of recesses 1610 to allow one of connectors 205 to be secured therein to release from recess 1610 and disengage from hub assembly 1636.

Referring to FIG. 16B , outer hub member 1642 is rotatably mounted relative to inner hub member 1640 . For example, in the illustrated embodiment, hub assembly 1636 also includes a pinion gear 1614 , and outer hub member 1642 includes a ring gear 1616 operably coupled to pinion gear 1614 . In some embodiments, pinion 1614 is operatively coupled to drive shaft 552 ( FIGS. 5D-5F ), which extends from hub assembly 1636 , through hub shaft 316 ( FIG. 4 ), and to hub shaft handle 326 ( FIGS. 6A-6C ). Referring to FIGS. 6A-6C and 16B together, the hub shaft handle 326 can be manipulated/actuated by the user to actuate the drive shaft 552 to drive (e.g., rotate) the pinion gear 1614, thereby rotating the outer hub member 1642 relative to the inner hub member 1640 to release the connector 205 of the implantable device 200 during device deployment ( FIGS. 2A and 2B ).

More specifically, referring to Figures 2A, 2B, 16A, and 16B together, outer hub member 1642 may be rotated to align openings 1612 over corresponding recesses 1610 to release connector 205 therein. In operation, the hub assembly 1636 may initially be positioned as shown in FIG. 16A with the openings 1612 misaligned with the recesses 1610 such that each connector 205 is constrained by the outer hub assembly 1642 within a corresponding one of the recesses 1610 . The outer hub member 1642 may then be rotated to sequentially align the openings 1612 over each recess 1610 (including the connectors 205 at the rear portion P) to sequentially release those connectors 205 before being further rotated to sequentially align the openings 1612 over the respective recesses 1610 (including the connectors 205 at the front portion A) to sequentially release those connectors 205. In this manner, the hub assembly 1636 can provide sequential, multi-stage release of the posterior portion P and the anterior portion A of the implantable device 200 of the connector.

In the illustrated embodiment, the openings 1612 are configured (eg, shaped and sized) to sequentially position each recess 1610 to release the connector 205 therein. In some aspects of the present technology, the individual (eg, one-by-one) release of links 205 may improve control over deployment of atrial fixation member 202 . In other embodiments, opening 1612 may be sized to position two or more recesses 1610 simultaneously, for example to facilitate simultaneous release of multiple connectors 205 secured therein. In some embodiments, outer hub member 1642 has two or more openings 1612 spaced about its circumference such that relative rotation of inner hub member 1640 and outer hub member 1642 provides simultaneous release of multiple connectors 205 secured therebetween.

In some embodiments, hub assembly 1636 may have a relatively shorter length than hub assemblies 436 and 1536 described in detail above with reference to FIGS. In some aspects of the present technology, reducing the reduced length of hub assembly 1636 can help improve directional control of hub assembly 1636 in tight anatomies.

V. Further Examples

The following examples illustrate several embodiments of the present technology:

1. A delivery system for implanting a valve repair device in a mitral valve vessel, the delivery system comprising:

a delivery catheter having a distal portion configured to be intravascularly delivered to the left atrium, wherein the distal portion is configured to maintain the valve repair device in a delivery state;

a hub shaft extending through the delivery catheter, having a proximal portion and a distal portion;

a hub assembly coupled to the distal portion of the hub shaft, wherein—

the hub assembly includes an inner hub member movable relative to the outer hub member between a first position, a second position, and a third position,

In the first position, the hub is configured to secure the first end portion of the valve repair device between the inner hub component and the outer hub component,

movement of the inner hub member from the first position to the second position is configured to release the first side portion of the first end portion of the valve repair device, and

movement of the inner hub member from the second position to the third position is configured to release the second side portion of the first end portion of the valve repair device to release the first end portion from the hub; and

A mandrel extends through and independently moves relative to the hub shaft, the mandrel having a plug assembly configured to releasably engage the second end portion of the valve repair device.

2. The delivery system of example 1, wherein the inner hub comprises a plurality of recesses configured to receive respective ones of the plurality of connectors of the valve repair device.

3. The delivery system of example 2, wherein the recesses comprise a set of first recesses and a set of second recesses, wherein each of the second recesses has a different shape than the first recesses.

4. The delivery system of example 3, wherein the inner hub component includes a distal edge and a proximal edge, wherein the first recess extends partially from the distal edge toward the proximal edge, and wherein the second recess extends farther from the distal edge toward the proximal edge than the first recess.

5. The delivery system of example 3 or example 4, wherein—

In the first position, the first and second recesses are covered by the outer hub member;

In the second position, (a) the first recess is positioned distally of the outer hub member to allow partial release of the first side of the valve repair device, and (b) the second recess is covered by the outer hub member; and

In the third position, the first and second recesses are positioned distally of the outer hub to allow release of the second side portion of the valve repair device.

6. The delivery system of any of examples 3-5, wherein the set of first recesses and the set of second recesses are spaced circumferentially around the inner hub member.

7. The delivery system of any of examples 1-6, wherein the hub assembly further comprises a detent configured to engage the inner and outer hub components in the second position to inhibit movement of the inner hub component from the second position to the third position.

8. The delivery system of example 7, further comprising a release shaft operably coupled to the lock pin, wherein the release shaft is actuatable to allow the lock pin to disengage from the outer hub to allow the inner hub to move from the second position to the third position.

9. The delivery system of example 8, wherein the lock pin includes a release cavity configured to receive a release shaft therein, wherein the release shaft is configured to bias the lock pin radially outward to engage the outer hub component, and wherein the release shaft is removable from the release cavity to allow the lock pin to disengage from the outer hub component.

10. The delivery system of any one of examples 1-9, further comprising a drive shaft, wherein the hub assembly includes a lead screw operatively coupling the drive shaft to the inner hub member, and wherein rotation of the drive shaft rotates the lead screw to move the inner hub between first, second, and/or third positions.

11. The delivery system of example 10, wherein the inner hub member includes a stop surface, and wherein the lead screw includes a stop portion configured to engage the stop surface in the third position to inhibit further movement of the inner hub member from the third position in a direction away from the second position.

12. A delivery system for implanting a medical device having an atrial fixation member and an engagement member extending from the atrial fixation member, the delivery system comprising:

a hub shaft having a hub assembly configured to releasably engage the atrial fixation member; and

a mandrel extending through the hub shaft and having a plug configured to releasably engage the engagement member,

wherein the hub and mandrel are independently movable relative to each other to vary the axial length of the medical device,

wherein the hub is actuatable to release the atrial fixation member, and

Therein, the mandrel may be actuated to release the engagement member.

13. The delivery system of example 12, wherein the atrial fixation member has a posterior side and an anterior side, wherein the hub assembly is movable between a first position, a second position, and a third position, and wherein—

In the first position, the hub assembly is configured to secure the posterior and anterior sides of the atrial fixation member,

movement of the hub assembly from the first position to the second position is configured to release the posterior side of the atrial fixation member from the hub assembly, and

Movement of the hub assembly from the second position to the third position is configured to release the anterior side of the atrial fixation member from the hub assembly.

14. The delivery system of example 13, further comprising:

a hub shaft handle coupled to the proximal portion of the hub shaft; and

A drive shaft extends through the hub shaft and operably couples the hub assembly to the hub shaft handle, wherein the hub shaft handle includes a drive actuator configured to drive the drive shaft to move the hub assembly between first, second, and/or third positions.

15. The delivery system of example 14, wherein the drive actuator comprises a ring gear.

16. The delivery system of any of examples 13-15, wherein the hub assembly further comprises a locking mechanism configured to inhibit movement of the hub assembly from the second position to the third position.

17. The delivery system of example 16, further comprising:

a hub shaft handle coupled to the proximal portion of the hub shaft; and

A release shaft extends through the hub shaft and operably couples the locking mechanism to the hub shaft handle, wherein the hub shaft handle includes a release actuator configured to disengage the release shaft from the locking mechanism to allow movement of the hub assembly from the second position to the third position.

18. The delivery system of example 17, wherein the release actuator is a pulling member configured to pull the release shaft proximally away from the hub assembly.

19. The delivery system of any one of examples 16-18, further comprising:

a hub shaft handle coupled to the proximal portion of the hub shaft;

a drive shaft extending through the hub shaft and operatively coupling the hub assembly to the hub shaft handle, wherein the hub shaft handle includes a drive actuator configured to drive the drive shaft to move the hub assembly between first, second and/or third positions; and

A release shaft extends through the hub shaft and operably couples the locking mechanism to the hub shaft handle, wherein the hub shaft handle further includes a release actuator configured to disengage the release shaft from the locking mechanism to allow movement of the hub assembly from the second position to the third position.

20. The delivery system of any of examples 12-19, wherein the bung includes a screw configured to releasably couple a delivery attachment member of the engagement member.

21. The delivery system of any one of examples 12-20, further comprising:

a mandrel handle coupled to the proximal portion of the mandrel; and

A drive shaft extends through the mandrel and operably couples the bung to the mandrel handle, wherein the mandrel handle includes a drive actuator configured to drive the drive shaft to disengage the bung from the engagement member.

22. The delivery system of example 21, further comprising a tendon extending through the mandrel and operably coupling the atrial fixation member to the mandrel handle, wherein the mandrel handle includes a tightening actuator configured to tension the tendon to radially compress the atrial fixation member.

23. The delivery system of example 22, wherein the mandrel handle includes a mount assembly having a body, a mount configured to secure the tendon, and a biasing member operatively coupling the mount to the body, and wherein the tightening actuator is coupled to the body and configured to move the mount assembly to tension the tendon.

24. The delivery system of example 23, wherein movement of the mounting assembly in a first direction loads the biasing member.

25. A method of implanting a valve repair device at a heart valve, the method comprising:

intravascularly delivering the distal portion of the delivery catheter into the chamber of the heart;

unsheathing at least a portion of the valve repair device from the delivery catheter while the valve repair device is in the heart chamber;

Compressing the valve repair device longitudinally by moving one or both of the following relative to each other: (a) a hub shaft fixed to a first end portion of the valve repair device and (b) a mandrel fixed to a second end portion of the valve repair device;

advancing the valve repair device to a target location extending across the heart valve such that the first end portion is positioned on a first side of the heart valve upstream of a native valve annulus of the heart valve, and the second end portion is positioned on a second side of the heart valve proximate the native valve leaflets of the heart valve;

releasing the second end portion of the valve repair device from the mandrel;

releasing the first side of the first end portion of the valve repair device from the hub shaft; and

After the first side of the first end portion of the valve repair device is released, the second side of the first end portion of the valve repair device is released from the hub shaft.

26. The method of example 25, wherein releasing the first side of the first end portion of the valve repair device comprises actuating a handle operably coupled to the proximal portion of the hub shaft to drive a hub assembly coupled to the distal portion of the hub shaft to release the plurality of first connectors on the first side of the first end portion of the valve repair device.

27. The method of example 26, wherein releasing the second side of the first end portion of the valve repair device comprises further actuating a handle to drive a hub assembly to release the plurality of second connectors on the second side of the first end portion of the valve repair device.

28. The method of any one of examples 25-27, wherein the heart valve is a mitral valve, and wherein the method further comprises capturing a portion of one or more native leaflets of the mitral valve with a valve repair device.

29. The method of any of examples 25-28, wherein the heart valve is a mitral valve, and wherein longitudinally compressing the valve repair device comprises longitudinally compressing the valve repair device in the left atrium above the mitral valve.

30. The method of any one of examples 25-29, wherein the valve repair device comprises an atrial fixation member and an engagement member extending from the atrial fixation member, wherein the first end portion is of the atrial fixation member, wherein the second end portion is the engagement member, and wherein—

releasing the first side of the first end of the valve repair device includes releasing a rear side of the atrial fixation member overlying the engagement member; and

Releasing the second side of the first end of the valve repair device includes releasing the anterior side of the atrial fixation member opposite the posterior side.

31. The method of any one of examples 25-30, wherein releasing the second end portion of the valve repair device from the mandrel comprises actuating a handle operably coupled to the mandrel to drive the mandrel out of a delivery attachment member fixedly attached to the second end portion of the valve repair device.

32. The method of any of examples 25-32, wherein the delivery attachment member is a nut, and wherein actuating the handle to drive the mandrel to disengage the nut comprises rotating a threaded member of the mandrel to disengage the nut.

33. A delivery system for implanting a medical device comprising:

a hub shaft having a proximal portion and a distal portion; and

a hub assembly coupled to the distal portion of the hub shaft, wherein—

the hub assembly includes an inner hub assembly movable relative to the outer hub assembly between a first position, a second position, and a third position,

In the first position, the hub is configured to secure the end of the medical device between the inner and outer hub components,

movement of the inner hub member from the first position to the second position is configured to release the first side portion of the end of the medical device, and

Movement of the inner hub member from the second position to the third position is configured to release the second side portion of the end of the medical device to release the medical device from the hub.

34. A method of implanting a medical device at a heart valve, the method comprising:

Advancing the medical device to a target location extending across the heart valve such that (a) the first end portion of the medical device is positioned on a first side of the heart valve upstream of a native annulus of the heart valve, and (b) the second end portion of the medical device is positioned on a second side of the heart valve proximate the native leaflets of the heart valve, wherein advancing the medical device to the target location includes advancing the medical device while the first end portion of the medical device is coupled to the first shaft and the second end portion of the medical device is coupled to the second shaft;

releasing the first side of the first end of the medical device from the first shaft;

releasing the second side of the first end portion of the medical device from the first shaft after releasing the first side of the first end portion of the medical device; and

The second end portion of the medical device is released from the second shaft.

35. The method of example 34, wherein releasing the first side of the first end portion of the medical device comprises actuating a handle operably coupled to the proximal end portion of the first shaft to drive a hub assembly coupled to the distal portion of the first shaft to release the plurality of first connectors at the first side of the first end portion of the medical device.

36. The method of example 35, wherein releasing the second side of the first end portion of the medical device comprises further actuating the handle to drive the hub assembly to release the plurality of second connections at the second side of the first end portion of the medical device.

37. The method of any one of examples 34-36, wherein the first end portion of the medical device is coupled to the first shaft via a hub assembly, wherein the hub assembly includes an inner hub member movable relative to an outer hub member between a first position, a second position, and a third position, wherein—

advancing the medical device to the target location includes advancing the medical device while the inner hub is in the first position,

releasing the first side of the first end portion of the medical device includes moving the inner hub member from the first position to the second position, and

Releasing the second side of the first end portion of the medical device includes moving the inner hub member from the second position to the third position.

38. The method of any one of examples 34-37, wherein the first end portion of the medical device is coupled to the first shaft via a hub assembly, wherein the hub assembly includes an inner hub member translatable relative to an outer hub member, and wherein—

advancing the medical device to the target location includes advancing the medical device while the inner hub member is in the first position relative to the outer hub member,

releasing the first side of the first end portion of the medical device includes translating the inner hub member to a second position relative to the outer hub member, and

Releasing the second side of the first end portion of the medical device includes translating the inner hub member to a third position relative to the outer hub member.

39. The method of any one of examples 34-38, wherein the first end portion of the medical device is coupled to the first shaft via a hub assembly, wherein the hub assembly includes an inner hub member rotatable relative to an outer hub member, and wherein—

advancing the medical device to the target location includes advancing the medical device while the inner hub member is in the first position relative to the outer hub member,

releasing the first side of the first end portion of the medical device includes rotating the inner hub component relative to the outer hub component to a second position, and

Releasing the second side of the first end portion of the medical device includes rotating the inner hub member relative to the outer hub member to a third position.

40. The method of any one of examples 34-39, wherein the first end portion of the medical device includes a plurality of connectors coupled to the first shaft via a hub assembly, and wherein—

releasing the first side of the first end portion of the medical device includes sequentially releasing each of the first connectors, and

Releasing the second side of the first end portion of the medical device includes sequentially releasing each second connector.

41. The method of any one of instances 34-40, wherein the first end portion of the medical device includes a plurality of connectors coupled to the first shaft via a hub assembly, and wherein—

releasing the first side of the first end portion of the medical device includes simultaneously releasing a plurality of first connectors, and

Releasing the second side of the first end portion of the medical device includes simultaneously releasing the plurality of second connectors.

42. The method of any one of examples 34-41, wherein the heart valve is a mitral valve, and wherein the method further comprises capturing a portion of one or more native leaflets of the mitral valve with the medical device.

43. The method of any of examples 34-42, wherein the method comprises releasing the second end portion of the medical device prior to releasing the first end portion of the medical device.

44. The method of any one of examples 34-44, wherein the medical device comprises an atrial fixation member and an engagement member extending from the atrial fixation member, wherein a first end portion belongs to the atrial fixation member, wherein a second end portion belongs to the engagement member, and wherein—

releasing the first side of the first end portion of the medical device includes releasing a rear side of the atrial fixation member overlying the engagement member; and

Releasing the second side of the first end portion of the medical device includes releasing the anterior side of the atrial fixation member opposite the posterior side.

45. A method of implanting a medical device into a heart valve, the method comprising:

advancing the medical device at least partially into the chamber of the heart, wherein advancing the medical device into the chamber includes advancing the medical device while the first end portion of the medical device is coupled to the first shaft and the second end portion of the medical device is coupled to the second shaft;

compressing the medical device longitudinally by moving one or both of the first and second shafts relative to each other;

advancing the medical device to a target location extending across the heart valve such that (a) the first end portion of the medical device is positioned on a first side of the heart valve upstream of a native annulus of the heart valve, and (b) the second end portion of the medical device is positioned on a second side of the heart valve proximate the native valve leaflets of the heart valve;

releasing the first end portion of the medical device from the first shaft; and

The second end portion of the medical device is released from the second shaft.

46. The method of example 45, wherein the heart valve is a mitral valve and the chamber is a left atrium, and wherein longitudinally compressing the medical device comprises longitudinally compressing the medical device in the left atrium above the mitral valve.

47. The method of example 46, wherein the method further comprises directing the medical device toward the mitral valve after longitudinally compressing the medical device.

48. A method of implanting a valve repair device at a heart valve, the method comprising:

intravascularly delivering the distal portion of the delivery catheter into the chamber of the heart;

unsheathing at least a portion of the valve repair device from the delivery catheter while in the heart chamber;

longitudinally compressing the valve repair device by moving one or both of the following relative to each other: (a) a hub shaft secured to a first end portion of the valve repair device and (b) a mandrel secured to a second end portion of the valve repair device;

advancing the valve repair device to a target location extending across the heart valve such that the first end portion is positioned on a first side of the heart valve upstream of a native annulus of the heart valve, and the second end portion is positioned on a second side of the heart valve proximate native valve leaflets of the heart valve;

releasing the second end portion of the valve repair device from the mandrel;

releasing the first side of the first end portion of the valve repair device from the hub shaft; and

After the first side of the first end portion of the valve repair device is released, the second side of the first end portion of the valve repair device is released from the hub shaft.

49. The method of example 48, wherein releasing the first side of the first end portion of the valve repair device comprises actuating a handle operably coupled to the proximal end portion of the hub shaft to drive a hub assembly coupled to the distal portion of the hub shaft to release the plurality of first connectors on the first side of the first end portion of the valve repair device, and wherein releasing the second side of the first end portion of the valve repair device comprises further actuating the handle to drive the hub assembly to release the plurality of second connectors on the second side of the first end portion of the valve repair device.

50. The method of example 48 or example 49, wherein the heart valve is the mitral valve and the chamber is the left atrium, wherein longitudinally compressing the valve repair device comprises longitudinally compressing the valve repair device in the left atrium above the mitral valve, and wherein the method further comprises capturing one or more portions of the native leaflets of the mitral valve with the valve repair device.

51. The method of any one of examples 48-50, wherein the valve repair device comprises an atrial fixation member and a coaptation member extending from the atrial fixation member, wherein the first end portion belongs to the atrial fixation member, wherein the second end portion belongs to the coaptation member, and wherein—

releasing the first side of the first end portion of the valve repair device includes releasing a rear side of the atrial fixation member positioned over the engagement member; and

Releasing the second side of the first end portion of the valve repair device includes releasing the anterior side of the atrial fixation member opposite the posterior side.

52. The method of any one of examples 48-51, wherein releasing the second end portion of the valve repair device from the mandrel comprises actuating a handle operably coupled to the mandrel to drive the mandrel away from a delivery attachment member fixedly attached to the second end portion of the valve repair device.

53. The method of example 52, wherein the delivery attachment member is a nut, and wherein actuating the handle to drive the mandrel off the nut comprises rotating a threaded member of the mandrel to disengage the nut.

VI. Conclusion

The above detailed description of embodiments of the technology is not intended to be exhaustive or to limit the technology to the precise forms disclosed above. While specific embodiments of, and examples for, the technology are described above for illustrative purposes, various equivalent modifications are possible within the scope of the technology, as those skilled in the relevant art will recognize. For example, although steps are presented in a given order, alternative embodiments may perform steps in a different order. Various embodiments described herein may also be combined to provide further embodiments.

From the foregoing it will be appreciated that specific embodiments of the technology are described herein for purposes of illustration, but well known structures and functions have not been shown or described in detail to avoid unnecessarily obscuring the description of the embodiments of the technology. Where the context allows, singular or plural terms may also include plural or singular terms, respectively.

In addition, unless the word "or" is expressly qualified to refer only to a single item in a list of two or more items excluding other items, the use of "or" in such a list shall be construed to include (a) any single item in the list, (b) all of the items in the list, or (c) any combination of items in the list. Additionally, the term "comprising" throughout means including at least one or more of the stated features such that any greater number of the same feature and/or additional types of other features are not excluded. It will also be understood that specific embodiments are described herein for purposes of illustration, but that various modifications may be made without departing from the technology. Furthermore, while advantages associated with certain embodiments of the present technology have been described in the context of these embodiments, other embodiments may exhibit these advantages as well, and not all embodiments need exhibit these advantages to fall within the scope of the present technology. Accordingly, the present disclosure and related art may include other embodiments not expressly shown or described herein.

Claims (53)

1. A delivery system for implanting a valve repair device within a mitral valve vessel, the delivery system comprising:

A delivery catheter having a distal portion configured to be intravascularly delivered to a left atrium, wherein the distal portion is configured to hold a valve repair device in a delivery state;

a hub shaft extending through the delivery catheter having a proximal portion and a distal portion;

hub assembly coupled to a distal portion of a hub shaft, wherein

The hub assembly includes an inner hub member movable relative to the outer hub member between a first position, a second position, and a third position,

in the first position, the hub is configured to secure a first end portion of the valve repair device between the inner hub component and the outer hub component,

movement of the inner hub member from the first position to the second position is configured to release a first side portion of the first end portion of the valve repair device, and

movement of the inner hub member from the second position to the third position is configured to release a second side portion of the first end portion of the valve repair device to release the first end portion from the hub; and

a mandrel extends through the hub shaft and moves independently relative to the hub shaft, the mandrel having a plug assembly configured to releasably engage a second end portion of the valve repair device.

2. The delivery system of claim 1, wherein the inner hub component comprises a plurality of recesses configured to receive respective ones of a plurality of connectors of the valve repair device.

3. The delivery system of claim 2, wherein the recesses comprise a set of first recesses and a set of second recesses, wherein the second recesses each have a different shape than the first recesses.

4. The delivery system of claim 3, wherein the inner hub component comprises a distal edge and a proximal edge, wherein the first recess extends from the distal edge partially toward the proximal edge, and wherein the second recess extends from the distal edge farther toward the proximal edge than the first recess.

5. The delivery system of claim 3, wherein- (or-a-is/are) is/are provided

In the first position, the first and second recesses are covered by the outer hub component;

in the second position, (a) a position of the first recess is disposed distally of the outer hub component to allow release of the first side portion of the valve repair device, and (b) the second recess is covered by the outer hub component; and

in the third position, the positions of the first and second recesses are disposed distally of the outer hub component to allow release of the second side portion of the valve repair device.

6. The delivery system of claim 3, wherein the set of first recesses are circumferentially spaced apart from the set of second recesses about the inner hub component.

7. The delivery system of claim 1, wherein the hub assembly further comprises a locking pin configured to mate the inner hub component and the outer hub component in the second position to inhibit movement of the inner hub component from the second position to the third position.

8. The delivery system of claim 7, further comprising a release shaft operatively connected to the locking pin, wherein the release shaft is actuatable to allow the locking pin to disengage from the outer hub component to allow the inner hub component to move from the second position to the third position.

9. The delivery system of claim 8, wherein the locking pin comprises a release cavity configured to receive a release shaft therein, wherein the release shaft is configured to bias the locking pin radially outward to engage the outer hub component, and wherein the release shaft is removable from the release cavity to allow the locking pin to disengage the outer hub component.

10. The delivery system of claim 1, further comprising a drive shaft, wherein the hub assembly comprises a lead screw operably coupling the drive shaft to the inner hub component, and wherein rotation of the drive shaft rotates the lead screw to move the inner hub between the first, second, and/or third positions.

11. The delivery system of claim 10, wherein the inner hub component comprises a stop surface, and wherein the lead screw comprises a stop portion configured to mate with the stop surface in a third position to inhibit further movement of the inner hub component from the third position in a direction away from the second position.

12. A delivery system for implanting a medical device having an atrial fixation member and an engagement member extending from the atrial fixation member, the delivery system comprising:

a hub shaft having a hub assembly configured to releasably engage the atrial fixation member; and

a spindle extending through the hub axle and having a plug configured to releasably engage the engagement member,

wherein the hub shaft and the spindle are independently movable relative to each other to vary the axial length of the medical device,

wherein the hub is actuatable to release the atrial fixation member, an

Wherein the spindle is actuatable to release the engagement member.

13. The delivery system of claim 12, wherein the atrial fixation member has a posterior side and an anterior side, wherein the hub assembly is movable between a first position, a second position, and a third position, and wherein- (a) is provided

In the first position, the hub assembly is configured to secure the posterior and anterior sides of the atrial fixation member,

movement of the hub assembly from the first position to the second position is configured to release a rear side of the atrial fixation member from the hub assembly, and

movement of the hub assembly from the second position to the third position is configured to release the anterior side of the atrial fixation member from the hub assembly.

14. The delivery system of claim 13, further comprising:

a hub axle handle coupled to a proximal portion of the hub axle; and

a drive shaft extending through the hub axle and operably coupling the hub assembly to the hub axle handle, wherein the hub axle handle includes a drive actuator configured to drive the drive shaft to move the hub assembly between the first, second, and/or third positions.

15. The delivery system of claim 14, wherein the drive actuator comprises a ring gear.

16. The delivery system of claim 13, wherein the hub assembly further comprises a locking mechanism configured to prevent movement of the hub assembly from the second position to the third position.

17. The delivery system of claim 16, further comprising:

a hub axle handle coupled to a proximal portion of the hub axle; and

A release shaft extending through the hub shaft and operably coupling the locking mechanism to the hub shaft handle, wherein the hub shaft handle includes a release actuator configured to disengage the release shaft from the locking mechanism to allow the hub assembly to move from the second position to the third position.

18. The delivery system of claim 17, wherein the release actuator is a pulling member configured to pull the release shaft proximally away from the hub assembly.

19. The delivery system of claim 16, further comprising:

a hub axle handle coupled to a proximal portion of the hub axle;

a drive shaft extending through the hub axle and operably coupling the hub assembly to a hub axle handle, wherein the hub axle handle includes a drive actuator configured to drive the drive shaft to move the hub assembly between the first, second, and/or third positions; and

a release shaft extending through the hub shaft and operably coupling the locking mechanism to the hub shaft handle, wherein the hub shaft handle further comprises a release actuator configured to disengage the release shaft from the locking mechanism to allow the hub assembly to move from the second position to the third position.

20. The delivery system of claim 12, wherein the plug comprises a screw configured to releasably couple with a delivery attachment member of the engagement member.

21. The delivery system of claim 12, further comprising:

a mandrel handle coupled to a proximal portion of the mandrel; and

a drive shaft extending through the spindle and operably coupling the plug to the spindle handle, wherein the spindle handle includes a drive actuator configured to drive the drive shaft to disengage the plug from the engagement member.

22. The delivery system of claim 21, further comprising a tendon extending through the mandrel and operably coupling the atrial fixation member to the mandrel handle, wherein the mandrel handle comprises a cinch actuator configured to tighten the tendon to radially compress the atrial fixation member.

23. The delivery system of claim 22, wherein the mandrel handle comprises a mounting assembly having a body, a mount configured to secure the tendon, and a biasing member operably coupling the mount to the body, and wherein the cinch actuator is coupled to the body and configured to move the mounting assembly to tighten the tendon.

24. The delivery system of claim 23, wherein movement of the mounting assembly in the first direction loads the biasing member.

25. A method of implanting a valve repair device at a heart valve, the method comprising:

intravascularly delivering a distal portion of a delivery catheter to a heart chamber;

unsheathing at least a portion of the valve repair device from the delivery catheter while the valve repair device is in the heart chamber;

longitudinally compressing the valve repair device by moving one or both of the following relative to each other: (a) A hub shaft secured to a first end portion of the valve repair device and (b) a mandrel secured to a second end portion of the valve repair device;

advancing the valve repair device to a target position extending across the heart valve such that the location of the first end portion is disposed on a first side of the heart valve upstream of a native annulus of the heart valve and the location of the second end portion is disposed on a second side of the heart valve proximate to native valve leaflets of the heart valve;

releasing the second end portion of the valve repair device from the mandrel;

releasing a first side of the first end portion of the valve repair device from the hub shaft; and

after releasing the first side of the first end portion of the valve repair device, releasing the second side of the first end portion of the valve repair device from the hub shaft.

26. The method of claim 25, wherein releasing the first side of the first end portion of the valve repair device comprises actuating a handle operatively coupled to the proximal end portion of the hub shaft to drive a hub assembly coupled to the distal end portion of the hub shaft to release the plurality of first connectors on the first side of the first end portion of the valve repair device.

27. The method of claim 26, wherein releasing the second side of the first end portion of the valve repair device comprises further actuating a handle to drive a hub assembly to release a plurality of second connectors located on the second side of the first end portion of the valve repair device.

28. The method of claim 25, wherein the heart valve is a mitral valve, and wherein the method further comprises capturing a portion of one or more native leaflets of the mitral valve with a valve repair device.

29. The method of claim 25, wherein the heart valve is a mitral valve, and wherein longitudinally compressing the valve repair device comprises longitudinally compressing the valve repair device in a left atrium above the mitral valve.

30. The method of claim 25, wherein the valve repair device comprises an atrial fixation member and an engagement member extending from the atrial fixation member, wherein the first end portion is the atrial fixation member, wherein the second end portion is the engagement member, and wherein the step is performed by the device

Releasing the first side of the first end of the valve repair device includes releasing a posterior side of an atrial fixation member located above the engagement member; and

releasing the second side of the first end of the valve repair device includes releasing an anterior side of the atrial fixation member opposite the posterior side.

31. The method of claim 25, wherein releasing the second end of the valve repair device from the mandrel comprises actuating a handle operably coupled to the mandrel to drive the mandrel out of fixed attachment to a delivery attachment member of the second end portion of the valve repair device.

32. The method of claim 25, wherein the delivery attachment member is a nut, and wherein actuating the handle to drive the mandrel to disengage the nut comprises rotating a threaded member of the mandrel to disengage the nut.

33. A delivery system for implanting a medical device, comprising:

a hub shaft having a proximal portion and a distal portion; and

hub assembly coupled to a distal portion of a hub shaft, wherein

The hub assembly includes an inner hub assembly movable relative to the outer hub assembly between a first position, a second position, and a third position,

in the first position, the hub is configured to secure an end of the medical device between the inner and outer hub members,

Movement of the inner hub member from the first position to the second position is configured to release a first side portion of the end of the medical device, and

movement of the inner hub member from the second position to the third position is configured to release a second side portion of the end of the medical device to release the medical device from the hub.

34. A method of implanting a medical device at a heart valve, the method comprising:

advancing the medical device to a target location extending across the heart valve such that (a) a location of a first end portion of the medical device is disposed on a first side of the heart valve upstream of a native annulus of the heart valve and (b) a location of a second end portion of the medical device is disposed on a second side of the heart valve proximate to a native leaflet of the heart valve, wherein advancing the medical device to the target location comprises advancing the medical device while the first end portion of the medical device is coupled to the first shaft and the second end portion of the medical device is coupled to the second shaft;

releasing a first side of the first end of the medical device from the first shaft;

releasing the second side of the first end portion of the medical device from the first shaft after releasing the first side of the first end portion of the medical device; and

releasing the second end portion of the medical device from the second shaft.

35. The method of claim 34, wherein releasing the first side of the first end portion of the medical device comprises actuating a handle operatively coupled to the proximal end portion of the first shaft to drive a hub assembly coupled to the distal end portion of the first shaft to release the plurality of first connectors on the first side of the first end portion of the medical device.

36. The method of claim 35, wherein releasing the second side of the first end portion of the medical device comprises further actuating the handle to drive the hub assembly to release a plurality of second connectors at the second side of the first end portion of the medical device.

37. The method of claim 34, wherein the first end portion of the medical device is coupled to the first shaft via a hub assembly, wherein the hub assembly comprises an inner hub member movable relative to an outer hub member between a first position, a second position, and a third position, wherein-

Advancing the medical device to the target location includes advancing the medical device while the inner hub member is in the first position,

releasing the first side of the first end portion of the medical device includes moving the inner hub member from the first position to the second position, and

Releasing the second side of the first end portion of the medical device includes moving the inner hub member from the second position to the third position.

38. The method of claim 34, wherein the first end portion of the medical device is coupled to the first shaft via a hub assembly, wherein the hub assembly comprises an inner hub component translatable relative to an outer hub component, and wherein

Advancing the medical device to the target location includes advancing the medical device while the inner hub member is in the first position relative to the outer hub member,

releasing the first side of the first end portion of the medical device includes translating the inner hub member to a second position relative to the outer hub member, and

releasing the second side of the first end portion of the medical device includes translating the inner hub member to a third position relative to the outer hub member.

39. The method of claim 34, wherein the first end portion of the medical device is coupled to the first shaft via a hub assembly, wherein the hub assembly includes an inner hub component rotatable relative to an outer hub component, and wherein

Advancing the medical device to the target location includes advancing the medical device while the inner hub member is in the first position relative to the outer hub member,

releasing the first side of the first end portion of the medical device includes rotating the inner hub member to a second position relative to the outer hub member, and

Releasing the second side of the first end portion of the medical device includes rotating the inner hub member relative to the outer hub member to a third position.

40. The method of claim 34, wherein the first end portion of the medical device comprises a plurality of connectors coupled to the first shaft via a hub assembly, and wherein

Releasing the first side of the first end portion of the medical device includes sequentially releasing each of the first connectors, an

Releasing the second side of the first end portion of the medical device includes sequentially releasing each of the second connectors.

41. The method of claim 34, wherein the first end portion of the medical device comprises a plurality of connectors coupled to the first shaft via a hub assembly, and wherein

Releasing the first side of the first end portion of the medical device includes simultaneously releasing a plurality of first connectors, an

Releasing the second side of the first end portion of the medical device includes simultaneously releasing a plurality of second connectors.

42. The method of claim 34, wherein the heart valve is a mitral valve, and wherein the method further comprises capturing a portion of one or more native leaflets of the mitral valve with the medical device.

43. The method of claim 34, wherein the method comprises releasing a second end portion of the medical device prior to releasing the first end portion of the medical device.

44. The method of claim 34, wherein the medical device comprises an atrial fixation member and an engagement member extending from the atrial fixation member, wherein a first end portion belongs to the atrial fixation member, wherein a second end portion belongs to the engagement member, and wherein- (a) is provided

Releasing the first side of the first end portion of the medical device includes releasing a rear side of the atrial fixation member located above the engagement member; and

releasing the second side of the first end portion of the medical device includes releasing an anterior side of the atrial fixation member opposite the posterior side.

45. A method of implanting a medical device into a heart valve, the method comprising:

advancing the medical device at least partially into the heart chamber, wherein advancing the medical device into the chamber comprises advancing the medical device while a first end portion of the medical device is coupled to the first shaft and a second end portion of the medical device is coupled to the second shaft;

longitudinally compressing the medical device by moving one or both of the first and second shafts relative to each other;

advancing the medical device to a target location extending across the heart valve such that (a) a location of a first end portion of the medical device is disposed on a first side of the heart valve upstream of a native annulus of the heart valve and (b) a location of a second end portion of the medical device is disposed on a second side of the heart valve, proximate to native valve leaflets of the heart valve;

Releasing the first end portion of the medical device from the first shaft; and

releasing the second end portion of the medical device from the second shaft.

46. The method of claim 45, wherein the heart valve is a mitral valve and the chamber is a left atrium, and wherein longitudinally compressing the medical device comprises longitudinally compressing the medical device in the left atrium above the mitral valve.

47. The method of claim 46, wherein the method further comprises controlling the direction of the medical device to turn toward the mitral valve after longitudinally compressing the medical device.

48. A method of implanting a valve repair device at a heart valve, the method comprising:

intravascularly delivering a distal portion of a delivery catheter to a heart chamber;

unsheathing at least a portion of the valve repair device from the delivery catheter while in the heart chamber;

longitudinally compressing the valve repair device by moving one or both of the following relative to each other: (a) A hub shaft secured to a first end portion of the valve repair device and (b) a mandrel secured to a second end portion of the valve repair device;

advancing the valve repair device to a target position extending across the heart valve such that the first end portion is positioned on a first side of the heart valve upstream of a native annulus of the heart valve and the second end portion is positioned on a second side of the heart valve, adjacent to native valve leaflets of the heart valve;

Releasing the second end portion of the valve repair device from the mandrel;

releasing the first side of the first end portion of the valve repair device from the hub shaft; and

after releasing the first side of the first end portion of the valve repair device, releasing the second side of the first end portion of the valve repair device from the hub shaft.

49. The method of claim 48, wherein releasing the first side of the first end portion of the valve repair device comprises actuating a handle operatively coupled to the proximal end portion of the hub shaft to drive a hub assembly coupled to the distal end portion of the hub shaft to release the first plurality of connectors on the first side of the first end portion of the valve repair device, and wherein releasing the second side of the first end portion of the valve repair device comprises further actuating the handle to drive the hub assembly to release the second plurality of connectors on the second side of the first end portion of the valve repair device.

50. The method of claim 48, wherein the heart valve is a mitral valve and the chamber is a left atrium, wherein longitudinally compressing the valve repair device comprises longitudinally compressing the valve repair device in the left atrium above the mitral valve, and wherein the method further comprises capturing one or more portions of a native leaflet of the mitral valve with the valve repair device.

51. The method of claim 48, wherein the valve repair device comprises an atrial fixation member and an engagement member extending from the atrial fixation member, wherein the first end portion belongs to the atrial fixation member, wherein the second end portion belongs to the engagement member, and wherein the step comprises

Releasing the first side of the first end portion of the valve repair device includes releasing a posterior side of an atrial fixation member located above the engagement member; and

releasing the second side of the first end portion of the valve repair device includes releasing an anterior side of the atrial fixation member opposite the posterior side.

52. The method of claim 48, wherein releasing the second end portion of the valve repair device from the mandrel comprises actuating a handle operatively coupled to the mandrel to drive the mandrel out of a delivery attachment member fixedly attached to the second end portion of the valve repair device.

53. The method of claim 52, wherein the delivery attachment member is a nut, and wherein actuating the handle to drive the mandrel out of the nut comprises rotating a threaded member of the mandrel to disengage the nut.