阅读说明：本技术 用于假体心脏瓣膜装置的具有系绳的递送系统及相关联的方法 (Delivery system with tether for prosthetic heart valve device and associated methods ) 是由 M·麦克里恩 于 2018-04-17 设计创作，主要内容包括：本文公开了用于假体心脏瓣膜装置的具有系绳的递送系统和相关联的方法。根据本技术的实施例构造的递送系统可包括例如细长导管主体、由细长导管主体承载并承载人工心脏瓣膜装置的递送囊状件、以及可滑动地设置在递送囊状件内的束紧构件。递送系统还可包括多个系绳元件,这些系绳元件联接于假体装置并延伸穿过束紧构件和导管主体。系绳元件的缩回可将假体装置的至少一部分推入束紧构件的远端部分中,以重新套住假体装置的至少一部分,并在假体装置已接触天然瓣膜的组织之后,允许将假体膜装置相对于天然瓣膜重新定位。(Disclosed herein are delivery systems with tethers and associated methods for prosthetic heart valve devices. A delivery system constructed in accordance with embodiments of the present technology can include, for example, an elongate catheter body, a delivery capsule carried by the elongate catheter body and carrying a prosthetic heart valve device, and a cinching member slidably disposed within the delivery capsule. The delivery system can further include a plurality of tether elements coupled to the prosthetic device and extending through the cinching member and the catheter body. Retraction of the tether element may push at least a portion of the prosthetic device into the distal end portion of the cinching member to recapture at least a portion of the prosthetic device and allow the prosthetic membrane device to be repositioned relative to the native valve after the prosthetic device has contacted tissue of the native valve.)

1. A delivery system for delivering a prosthetic heart valve device into a heart of a human patient, the delivery system comprising:

an elongate catheter body;

a capsule carried by the elongate catheter body and configured to move between (a) a stowed configuration for holding the prosthetic heart valve device and (b) a deployed configuration for at least partially deploying the prosthetic heart valve device;

a cinching member slidably disposed within at least a portion of a distal region of the bladder;

a plurality of tether elements extending through the cinching member and the catheter body to a proximal end thereof, wherein the tether elements are releasably coupled to the prosthetic heart valve; and

wherein proximal retraction of the tether element is configured to push at least a portion of the prosthetic heart valve device toward the distal end portion of the cinching member to recapture at least a portion of the prosthetic heart valve device and allow the prosthetic heart valve device to be repositioned relative to the native valve after the prosthetic heart valve device has contacted native valve tissue of the patient's heart.

2. The delivery system of claim 1, wherein the tether element is releasably attached to a ventricular end of the prosthetic heart valve device.

3. The delivery system of claim 1, wherein the tether element is removably coupled to a hook element on a ventricular end of the prosthetic heart valve device.

4. The delivery system of claim 1, wherein each of the tether elements extends through first and second loops on a ventricular end of the prosthetic heart valve device, and wherein the first and second loops are circumferentially spaced apart from each other on the ventricular end of the prosthetic heart valve device.

5. The delivery system of claim 1, further comprising:

a handle assembly located at a proximal portion of the elongate catheter body, the handle assembly having an actuator,

wherein each of the tether elements has a first end and a second end, wherein the first end is fixed and the second end is coupled to the actuator, and

wherein the actuator is configured to proximally retract and distally advance the tether element.

6. The delivery system of claim 1, further comprising a push rod extending through the catheter body and having a distal portion coupled to the cinching member.

7. The delivery system of claim 6, wherein the distal portion of the pushrod comprises a plurality of loops, and wherein the tether element extends through the loops and the pushrod.

8. The delivery system of claim 1, further comprising:

a distal platform movably positioned in the capsule, wherein the distal platform is configured to allow the prosthetic heart valve device to at least partially expand out of the capsule.

9. The delivery system of claim 8, wherein the tether element extends through an eyelet on the distal platform and is removably coupled to a corresponding mating feature of the prosthetic heart valve.

10. The delivery system of claim 8, wherein the distal platform and the cinching member are fixed relative to a handle assembly at the proximal portion of the catheter body.

11. The delivery system of claim 1, wherein the cinching member is axially movable relative to the bladder.

12. The delivery system of claim 1, wherein the cinching member is independently movable relative to the elongate catheter body and the bladder.

13. The delivery system of claim 1, wherein the capsule has a first diameter and the constricting member has a second diameter that is less than the first diameter.

14. The delivery system of claim 1, further comprising a handle assembly at a proximal portion of the elongate catheter body, the handle assembly having an actuator configured to pull and relax the tether element.

15. The delivery system of claim 14, wherein the actuator comprises a rotary actuator mechanism at the handle assembly.

16. The delivery system of claim 1, wherein the plurality of tether elements comprises three tether elements.

17. The delivery system of claim 1, wherein proximal retraction of the tether element is configured to push at least a portion of the prosthetic heart valve device into the distal end portion of the cinching member to recapture at least a portion of the prosthetic heart valve device.

18. A delivery system, the delivery system comprising:

an elongate catheter body having a distal portion and a proximal portion;

a handle assembly located at the proximal portion of the elongate catheter body;

a delivery capsule coupled to the elongate catheter body and configured to move between a delivery arrangement for holding a prosthetic heart valve device and a deployment arrangement for deploying the prosthetic heart valve device at least partially into a heart of a human patient, wherein the capsule has a first diameter;

a cinching member slidably disposed within at least a portion of the delivery bladder and the distal region of the catheter body, wherein the cinching member has a second diameter that is less than the first diameter and is axially movable relative to the catheter body and the delivery bladder; and

a plurality of tether elements releasably coupled to the prosthetic heart valve, wherein the tether elements extend from the prosthetic heart valve device through the cinching member and the catheter body to the handle assembly,

wherein retraction of the tether element toward the handle assembly is configured to move a ventricular end of the prosthetic heart valve device from an at least partially deployed arrangement to a collapsed arrangement, a third diameter of the collapsed arrangement being less than the first diameter.

19. The delivery system of claim 18, wherein the tether element loops around a mating feature at a ventricular end of the prosthetic heart valve device.

20. The delivery system of claim 18, wherein each of the tether elements extends from the distal end portion of the cinch member and through at least first and second mating features on the ventricular end of the prosthetic heart valve device, and wherein the first and second mating features are circumferentially spaced apart from one another on the ventricular end of the prosthetic heart valve device.

21. The delivery system of claim 18, wherein the handle assembly comprises an actuator operably coupled to the tether, wherein the actuator is configured to retract the tether element proximally and advance the tether element distally.

22. The delivery system of claim 18, further comprising a platform slidably disposed in the delivery capsule, wherein the platform is positioned to allow the prosthetic heart valve device to at least partially expand out of the delivery capsule.

23. A method for delivering a prosthetic heart valve device to a native mitral valve of a human patient's heart, the method comprising:

positioning a delivery capsule of an elongate catheter body within a heart, the delivery capsule carrying the prosthetic heart valve device;

deploying the prosthetic heart valve device from the delivery capsule to allow radial expansion of the prosthetic heart valve device against tissue of the native mitral valve;

extending a distal portion of a lacing member beyond a distal end of the delivery capsule;

retracting a plurality of tether elements coupled to the prosthetic heart valve device via a handle assembly located at a proximal portion of the elongate catheter body, wherein the tether elements extend through the cinching member, and wherein retracting the tether elements at least partially constricts the prosthetic heart valve device to recapture at least a portion of the prosthetic heart valve device; and

repositioning the prosthetic heart valve device relative to the native mitral valve while at least partially encasing the prosthetic heart valve device.

24. The method of claim 23, wherein retracting the tether element contracts a ventricular portion of the prosthetic heart valve device to a first diameter, the first diameter being less than an inner diameter of the delivery capsule.

25. The method of claim 23, wherein retracting the tether element moves at least a ventricular portion of the prosthetic heart valve device into the distal portion of the constricting member.

26. The method of claim 23, wherein deploying the prosthetic heart valve device comprises: fully expanding the prosthetic heart valve device prior to retracting the tether element to at least partially recapture the prosthetic heart valve device.

27. The method of claim 23, wherein:

deploying the prosthetic heart valve device from the delivery capsule comprises: sliding a platform in the delivery capsule toward a first configuration; and

retracting the plurality of tether elements allows a ventricular end portion of the prosthetic heart valve device to at least partially wrap around the platform.

28. The method of claim 23, further comprising releasing the tether element from the prosthetic heart valve device after fully deploying the prosthetic heart valve device.

29. The method of claim 23, wherein retracting the plurality of tether elements comprises rotating an actuator at the handle assembly.

30. The method of claim 23, further comprising manipulating an actuator of the handle assembly to pull and relax the tether element.

31. A delivery system for delivering a prosthetic heart valve device into a heart of a human patient, the delivery system comprising:

an elongate catheter body;

a capsule carried by the elongate catheter body and configured to move between (a) a stowed configuration for holding the prosthetic heart valve device and (b) a deployed configuration for at least partially deploying the prosthetic heart valve device;

a cinching member slidably disposed within at least a portion of a distal region of the bladder;

at least one tether element extending through the cinching member and the catheter body to a proximal end thereof, wherein the tether element is releasably coupled to the prosthetic heart valve;

a tether assembly fixedly attached to the prosthetic heart valve device, wherein the tether assembly comprises a plurality of arm members extending from a ventricular end portion of the prosthetic heart valve device and a mating feature coupled to the arm members, wherein the prosthetic feature is releasably attached to the tether element; and

wherein proximal retraction of the tether element is configured to push at least a portion of the prosthetic heart valve device into the distal end portion of the cinching member to recapture at least a portion of the prosthetic heart valve device and allow the prosthetic heart valve device to be repositioned relative to the native valve after the prosthetic heart valve device has contacted native valve tissue of the patient's heart.

Technical Field

The present technology relates generally to systems for delivering prosthetic heart valve devices. In particular, several embodiments of the present technology relate to a delivery system having a tether and associated methods for percutaneous delivery of a prosthetic heart valve device into a heart valve.

Background

Heart valves can be affected by a variety of conditions. For example, the mitral valve can be affected by mitral regurgitation, mitral valve prolapse, and mitral valve stenosis. Mitral regurgitation is the abnormal leakage of blood from the left ventricle to the left atrium caused by heart disease, in which case the leaflets of the mitral valve fail to coapt into apposition at the peak systolic pressure. The mitral valve leaflets may not be sufficiently coaptated because heart disease typically causes the heart muscle to dilate, which in turn dilates the native mitral annulus during contraction to the point where the leaflets coapt loosely. Abnormal reflux also occurs when papillary muscle function is impaired due to ischemia or other conditions. More specifically, as the left ventricle contracts during contraction, the affected papillary muscles do not contract sufficiently to affect proper closure of the leaflets.

Mitral valve prolapse is a condition in which the leaflets of the mitral valve bulge abnormally to the left atrium. This can cause irregular behavior of the mitral valve and lead to mitral regurgitation. Since the chordae tendineae (chordae tendineae) connecting the papillary muscles to the underside of the mitral valve leaflets may tear or stretch, the leaflets may prolapse and fail to coapt. Mitral stenosis is a narrowing of the mitral valve orifice that impedes left ventricular filling at diastole.

Mitral regurgitation is commonly treated with diuretics and/or vasodilators to reduce the amount of blood that flows back into the left atrium. Surgical methods of repairing or replacing valves (open and intravascular) have also been used to treat mitral regurgitation. For example, typical repair techniques include constricting or resecting portions of the dilated annulus. Tightening, for example, involves implanting a ring or peri-annular (peri-annular) ring that is typically secured to the annulus or surrounding tissue. Other repair procedures suture or clamp the valve leaflets together to partially appose the leaflets to each other.

Alternatively, more invasive procedures replace the entire valve itself by implanting a mechanical valve or biological tissue into the heart to replace the native mitral valve. These invasive procedures usually require large open chest surgery and are therefore very painful, highly ill and require a long recovery period. In addition, in many repair and replacement procedures, durability of the device or improper sizing of the annuloplasty ring or replacement valve may also present other problems to the patient. Repair procedures also require a skilled cardiac surgeon because poor or incorrect placement of the suture may affect the success of the procedure.

In recent years, less invasive aortic valve replacement methods have been employed. Examples of preassembled percutaneous prosthetic valves include, for example, Medtronic/Corevalve Inc (Irvine), of Medtronic/Corevalve Inc.) of californiaSystems and Edwards Life sciences (Edwards Lifesciences), gulf City Calif., USA

And (4) a valve. Both valve systems include an expandable frame and a tri-leaflet bioprosthetic valve attached to the expandable frame. The aortic valve is substantially symmetrical, circular and has a muscle ring. In aortic applications, the expandable frame has a symmetrical circular shape at the aortic annulus in order to match the native anatomy, but also because tri-leaflet prosthetic valves require circular symmetry for proper coaptation of the prosthetic leaflets. Thus, aortic valve resolutionThe anatomy lends itself to accommodating the expandable frame of the replacement valve because the aortic valve anatomy is substantially uniform, symmetric, and muscular. However, other heart valves are not anatomically uniform, asymmetric, or underdeveloped in muscle, and thus transvascular aortic valve replacement may not be suitable for other types of heart valves.

The present technology relates generally to delivery systems with tethering features for prosthetic heart valve devices and associated methods. Referring to fig. 1-24, specific details of several embodiments of the present technology are described herein. Although many embodiments are described with respect to devices, systems, and methods for delivering a prosthetic heart valve device to a native mitral valve, other applications and other embodiments in addition to those described herein are within the scope of the present technology. For example, at least some embodiments of the present technology may be used to deliver a prosthesis to other valves, such as the tricuspid or aortic valves. It should be noted that other embodiments in addition to those disclosed herein are within the scope of the present technology. Further, embodiments of the present technology may have configurations, components, and/or procedures different from those shown or described herein. Further, those of ordinary skill in the art will understand that embodiments of the present technology may have configurations, components, and/or procedures other than those illustrated or described herein, and that other embodiments may lack several of the configurations, components, and/or procedures illustrated or described herein without departing from the present technology.

With respect to the terms "distal" and "proximal" in this specification, unless otherwise indicated, the terms may refer to the relative positions of portions of the prosthetic valve device and/or associated delivery device with respect to an operator and/or a location in the vasculature or heart. For example, with reference to a delivery catheter adapted to deliver and position the prosthetic heart valves described herein, "proximal" may refer to a location closer to an operator of the device or entering an incision in a vessel, while "distal" may refer to a location further from the operator of the device or further from the incision along the vessel (e.g., an end of the catheter). For prosthetic heart valve devices, the terms "proximal" and "distal" may refer to the position of portions of the device relative to the direction of blood flow. For example, proximal may refer to a location or position upstream of the blood flow into the device (e.g., an inflow region), while distal may refer to a location or position downstream of the blood flow out of the device (e.g., an outflow region).

Overview

Several embodiments of the present technology are directed to delivery systems and mitral valve replacement devices that address the unique challenges of percutaneous replacement of a native mitral valve and are well suited for recapturing in a percutaneous delivery device after being partially deployed to reposition or remove the device. Percutaneous mitral valve replacement faces unique anatomical obstacles compared to replacing the aortic valve, which makes percutaneous mitral valve replacement more challenging than aortic valve replacement. First, unlike the relatively symmetrical and uniform aortic valve, the mitral annulus is non-circular D-shaped or kidney-shaped, having a non-planar, saddle-shaped geometry that generally lacks symmetry. The complex and highly variable anatomy of the mitral valve makes it difficult to design a mitral valve prosthesis that conforms well to the native mitral annulus of a particular patient. As a result, the prosthesis may not fit well with the native leaflets and/or annulus, possibly leaving gaps that allow blood to flow back. For example, placement of a cylindrical valve prosthesis in a native mitral valve may leave a gap in the commissure regions of the native valve through which paravalvular leakage may occur.

Prosthetic valves currently developed for percutaneous aortic valve replacement are not suitable for mitral valves. First, many of these devices require a direct structural connection between the stent-like structure that contacts the annulus and/or leaflets and the prosthetic valve. In several devices, the stent posts that support the prosthetic valve also contact the annulus or other surrounding tissue. When the heart contracts, these types of devices transfer forces exerted by the tissue and blood directly to the valve stent and prosthetic leaflets, which in turn deforms the valve stent from its desired cylindrical shape. This is an alarming problem because most heart replacement devices use a tri-leaflet valve, which requires a substantially symmetrical cylindrical support around the prosthetic valve to properly open and close the three leaflets over a lifetime. As a result, when these devices are subjected to movement and forces from the annulus and other surrounding tissue, the prosthesis may be compressed and/or deformed, causing failure of the prosthetic leaflets. In addition, the diseased mitral annulus is much larger than any available prosthetic aortic valve. As valve size increases, the forces on the valve leaflets also increase dramatically, and thus simply increasing the size of the aortic prosthesis to that of the dilated mitral annulus would require significantly thicker, taller leaflets and may not be feasible.

In addition to the irregular, complex shape of the mitral annulus that changes size during each heartbeat, the mitral annulus also lacks a great deal of radial support from the surrounding tissue. In contrast to aortic valves which are completely surrounded by fibroelastic tissue, providing adequate support for anchoring the prosthetic valve, the mitral valve is constrained only by muscular tissue on the outer wall. The inner wall of the mitral valve anatomy is constrained by a thin vessel wall that separates the mitral annulus from the lower portion of the aortic outflow tract. As a result, significant radial forces on the mitral annulus, such as those exerted by an expanded stent prosthesis, can cause the lower portion of the aortic tract to collapse. In addition, larger prostheses exert greater force and expand to larger sizes, which exacerbates the problem in mitral valve replacement applications.

The chordae tendineae of the left ventricle may also present an obstacle in deploying the mitral valve prosthesis. Unlike the aortic valve, the mitral valve has an intricate tether under the left ventricular leaflets that limits the motion and position of the deployment catheter and replacement device during implantation. As a result, it is complicated to deploy, position and anchor valve replacement devices on the ventricular side of the native mitral annulus.

Embodiments of the present technology provide systems, methods, and apparatus for treating a heart valve of a body, such as a mitral valve, that address challenges associated with the anatomy of the mitral valve and provide methods of repositioning and removing partially deployed devices. These devices and methods can be used for percutaneous approaches using catheters delivered intravenously or intra-arterially into the heart or by insertion into a cannula through the wall of the heart. For example, these devices and methods are particularly suited for transseptal and transapical approaches, but may also be transatrial and direct aortic delivery of prosthetic replacement valves to a target location in the heart. In addition, the various embodiments of the devices and methods described herein may be combined with many known procedures and procedures, such as known methods of accessing a heart valve (e.g., mitral or tricuspid valve) using an antegrade or retrograde approach, and combinations thereof.

The systems and methods described herein facilitate resheathing of a prosthetic heart valve device after partial or full deployment of the heart valve device. The disclosed delivery system includes tether elements that are releasably attached to the heart valve device and retracted to facilitate recapturing the device. For example, retraction of the tether element may at least partially collapse a ventricular portion of the heart valve device, and the open end of the delivery capsule may receive the end of the constriction to begin resheathing. In certain embodiments, the partially collapsed portion of the heart valve device can be received in a constricting member protruding from the delivery capsule and further facilitate contraction of a ventricular portion of the heart valve device. Such partial or complete recapping of the heart valve device allows the clinician to reposition the device or remove the device in vivo after partial or complete deployment of the device.

Into the mitral valve

To better understand the structure and operation of a valve replacement device according to the present techniques, it is helpful to first understand the method used to implant the device. The mitral valve or other type of atrioventricular valve can be accessed percutaneously through a blood vessel of a patient. Percutaneous refers to percutaneous access to a location remote from the heart through the skin, typically using a surgical resection procedure or a minimally invasive procedure, such as access using a needle via the Seldinger (Seldinger) technique. The ability to percutaneously access distant vasculature is well known and described in the patent and medical literature. Depending on the point of vascular access, access to the mitral valve may be antegrade and may rely on access through the interatrial septum to the left atrium (e.g., transseptal approach). Alternatively, access to the mitral valve may be retrograde, in which the left ventricle is accessed through the aortic valve. Access to the mitral valve may also be achieved via a transapical approach using a cannula. Depending on the method, interventional tool and support catheter(s), may be advanced intravascularly to the heart and positioned adjacent to the targeted heart valve in various ways.

Figure 1 shows stages of a transseptal approach for implanting a valve replacement device. In a transseptal approach, the access is passed through the interatrial septum IAS via the inferior or superior vena cava IVC, SVC via the right atrium RA, and into the left atrium LA above the mitral valve MV. As shown in fig. 1, a catheter 1 with a needle 2 is moved from the inferior vena cava IVC into the right atrium RA. Once the catheter 1 reaches the anterior side of the interatrial septum IAS, the needle 2 is advanced so that the needle 2 passes through the septum into the left atrium LA, for example at the fossa ovalis FO or foramen ovale. At this time, the needle 2 is replaced with a guide wire, and the catheter 1 is withdrawn.

Fig. 2 shows a subsequent stage of the transseptal approach in which the guidewire 6 and guide catheter 4 are passed through the atrial septum IAS. The guide catheter 4 provides access to the mitral valve for technically implanting the valve replacement device.

In an alternative antegrade approach (not shown), surgical access may be obtained through an intercostal incision, preferably without removing the ribs, while a small perforation or incision is made in the left atrial wall. The guide catheter is passed directly into the left atrium through the perforation or incision and sealed by purse string (pull string) sutures.

As mentioned above, the anterograde approach or transatrial septal approach to the mitral valve is advantageous in many respects. For example, antegrade approaches will generally enable more accurate and effective centering and stabilization of the guide catheter and/or prosthetic valve device. The antegrade approach may also reduce the risk of damaging chordae tendineae or other subvalvular structures with a catheter or other interventional tool. Furthermore, as in the retrograde approach, the antegrade approach may reduce the risk associated with crossing the aortic valve. This is particularly important for patients with prosthetic aortic valves because there is a risk that the prosthetic aortic valve will not pass through completely or not be substantially damaged.

Figures 3 and 4 illustrate examples of retrograde approaches to access the mitral valve. Access to the mitral valve MV may be achieved from the aortic arch AA, through the aortic valve AV, and into the left ventricle LV below the mitral valve MV. The aortic arch AA may be accessed by conventional femoral access routes or in a more direct approach via the brachial, axillary, radial or carotid arteries. Such access may be achieved through the use of a guidewire 6. Once in place, the guide catheter 4 can be tracked over the guidewire 6. Alternatively, surgical methods may be taken through incisions in the thoracic cavity, preferably to perform intercostal surgery without removing the ribs, and the guide catheter is placed in the aorta itself through the perforations. The guide catheter 4 is provided with a subsequent pathway to allow placement of the prosthetic valve device, as described in more detail herein. The retrograde approach advantageously does not require transseptal perforation. The retrograde approach is also more commonly used by cardiologists and is therefore more familiar.

Figure 5 illustrates a transapical method via transapical puncture. In this method, the heart is accessed via a chest incision, which may be a conventional thoracotomy or sternotomy, or a smaller intercostal or infrarenal pararenal incision or puncture. The access cannula is then placed through the puncture in the left ventricular wall at or near the apex of the heart. The catheter and prosthetic device of the present invention can then be introduced into the left ventricle through the access cannula. The transapical approach provides a shorter, straighter, and more direct path for the mitral or aortic valve. Further, since it does not involve intravascular access, the transapical method does not require training in interventional cardiology to perform the catheterization procedure required for other percutaneous approaches.

Selected embodiments of a delivery system for a prosthetic heart valve device

Fig. 6A is a side perspective view of a delivery system 100 with a prosthetic heart valve device 102 ("device 102") in an expanded state, in accordance with an embodiment of the present technique; fig. 6B is a partial schematic side view of a proximal portion of the delivery system 100; and figure 6C is a side view of the delivery system 100 with the device 102 in a partially retracted state. The delivery system 100 includes a catheter 104 having an elongate catheter body 106 ("catheter body 106"), the catheter body 106 having a distal portion 106a carrying a delivery bladder 108 ("bladder 108") and a proximal portion 106b coupled to a control unit or handle assembly 110. The capsule 108 is movable between a housed configuration for holding the device 102 in an undeployed state during delivery of the device 102 and a deployed configuration in which the device 102 is at least partially deployed from the capsule 108. The delivery system 100 further includes a cinching member 112 and a plurality of tether elements 114, the cinching member 112 being slidably disposed within at least a distal portion of the capsule 108, and the plurality of tether elements 114 being releasably coupled to the device 102. Tether element 114 may be a wire, suture, or cable that extends through cinching member 112 and through catheter body 106 to proximal portion 106b of catheter body 106. At the proximal portion 106b, the tether element 114 is operably coupled to an actuator 116 of the handle assembly 110, which actuator 116 can be manipulated to retract or release the tether element 114 proximally or distally.

In certain embodiments, the catheter 104 may be configured to be advanced over a guidewire 120 that may be used to guide the capsule 108 into the native heart valve. After the device 102 has been deployed (e.g., as shown in fig. 6A), proximal retraction of the tether element 114 (e.g., via the actuator 116 of the handle assembly 110) reduces the diameter of the proximal or ventricular end portion 134 of the device 102 and forces the device 102 and the distal end portion 118 of the cinching member 112 axially closer together to facilitate recapturing at least a portion of the device 102. Partial or complete resheathing of the device 102 allows for repositioning of the device 102 relative to the native heart valve (e.g., the native mitral valve) after a portion of the device 102 has contacted tissue of the native valve. As shown in fig. 6C, in certain embodiments, proximal retraction of tether element 114 pulls ventricular end portion 134 of device 102 into distal end portion 118 of lacing member 112 such that the end of device 102 is covered when the capsule is advanced distally for resheathing.

The handle assembly 110 may provide a steering capability (e.g., 360 degrees of rotation of the delivery capsule 108, 180 degrees of rotation of the delivery capsule 108, 3-axis steering, 2-axis steering, etc.) for delivering the capsule 108 to a target site (e.g., to the native mitral valve). The handle assembly 110 may also have additional features to initiate deployment of the device 102 at the target site. For example, the handle assembly 110 may include a control assembly 122 and a steering mechanism 124. The control assembly 122 may include rotating elements, such as knobs, that may be rotated to rotate the bladder 108 about its longitudinal axis. Control assembly 122 may also include buttons, levers, and/or other actuators that allow the clinician to control the deployment and/or recapping mechanism of delivery system 100. For example, the illustrated control assembly 122 includes an actuator 116 that can be rotated in a first direction to pull the tether element 114 proximally to at least partially recapture the device 102, and rotated in an opposite direction to slacken the tether element 114 to allow redeployment of the device 102. In other embodiments, the actuator 116 can be manipulated in a different manner (e.g., pulling) to pull the tether element 114 and to slacken the tether element 114. The actuator 116 can be operably coupled to a torsion or pulling mechanism that interacts with the tether element 114 to provide controlled movement of the tether element 114. The steering mechanism 124 can be used to steer the catheter 104 through the anatomy by bending the distal portion 106a of the catheter body 106 about a transverse axis. In other embodiments, the handle assembly 110 may include additional and/or different features that facilitate delivery of the device 102 to the target site.

The balloon 108 at the distal end portion 106a of the catheter body 106 includes a housing 126 configured to carry the device 102 and, optionally, an end cap 128 extending distally from the housing 126. As shown in fig. 6A, end cap 128 can include an opening 130 at its distal end through which opening 130 guidewire 120 can be passed to allow guidewire delivery to a target site. The end cap 128 can also have an atraumatic shape (e.g., partial spherical, frustoconical, blunt configuration, rounded configuration, etc.) to facilitate atraumatic delivery of the capsule 108 to a target site. In some embodiments, only the housing 126 carries the device 102 (e.g., the device is contained entirely within the housing 126), while in other embodiments, the end cap 128 can have a proximal sidewall such that a portion of the device 102 is contained within the end cap 128. The housing 126 and/or the end cap 128 may be made of metal, polymer, plastic, composite materials, combinations thereof, or other materials capable of retaining the device 102. As discussed in further detail below, manipulation of the handle assembly 110 pulls the capsule 108 in a proximal direction to move the capsule 108 from the containment configuration to the deployed configuration and to expand the device 102 from the capsule 108. In certain embodiments, the handle assembly 110 is manipulated to drive the end cap 128 in a distal direction to open the capsule 108. In other embodiments, the end cap 128 may be omitted, and the capsule 108 may include a proximal housing and a distal housing, both of which enclose portions of the device 102 in a contained configuration. During deployment, the proximal housing and the distal housing can be moved proximally and distally in a simultaneous or sequential manner to deploy the device 102 from the capsule 108.

As shown in fig. 6A, the delivery system 100 may further include a push rod 132, the push rod 132 extending through the catheter body 106 and being used to deploy the device 102 from the capsule 108. Push rod 132 has a distal end portion 132a (e.g., a platform) positioned proximate ventricular end portion 134 of device 102 and a proximal end portion 132b coupled to handle assembly 110. The push rod 132 may be made of metal, polymer, plastic, composite materials, combinations thereof, or other materials that have the flexibility necessary to navigate to the target site in the anatomy and sufficient stiffness to support the device 102 during delivery. In certain embodiments, the distal portion 132a may have a different flexibility than the proximal portion 132 b.

As indicated by arrow 101 of fig. 6A and arrow 103 of fig. 6C, the push rod 132 and the capsule 108 can be moved relative to one another to initiate deployment of the device 102 from the capsule 108. For example, proximal end portion 132b of pusher bar 132 can be fixed relative to handle assembly 110 such that distal movement of handle assembly 110 drives pusher bar 132 distally, thereby pressing distal end portion 132a of pusher bar 132 against ventricular end portion 134 of device 102 and causing at least a portion of device 102 to protrude from capsule 108. In other embodiments, the proximal portion 132b of the push rod 132 slides relative to the handle assembly 110 such that the handle assembly 110 can pull the balloon 108 proximally while the distal portion 132a of the push rod 132 maintains the device 102 in a substantially constant position relative to the longitudinal axis of the catheter body 106 to deploy the device 102. In further embodiments, the delivery system 100 may include other mechanisms for deploying the device 102 from the capsule 108.

In the embodiment shown in fig. 6A and 6C, lacing member 112 is a tubular structure that is fixedly coupled to distal end portion 132a of push rod 132 and is axially movable relative to bladder 108. Thus, movement of push rod 132 (e.g., via handle assembly 110 fixedly attached thereto) also moves lacing member 112. The cinching member 112 and the distal portion 132a of the push rod 132 may be received in the bladder 108 or the distal portion 106a of the catheter body 106. Thus, the diameter or outer dimension of the cinching member 112 is less than the diameter or inner dimension of the balloon 108, or if housed in the catheter body 106, the diameter or outer dimension of the cinching member 112 is less than the diameter or inner dimension of the distal portion 106a of the catheter body 106. The lacing member 112 can be made of a similar material as the push rod 132, such as a metal, polymer, and/or other material having sufficient rigidity to allow a portion of the device 102 to retract into the distal portion 118 of the lacing member 112. The lacing member 112 may be attached to the push rod 132 by welding, adhesive, and/or other attachment methods. In other embodiments, lacing member 112 may be integrally formed as an extension of push rod 132. In further embodiments, the cinching member 112 and push rod 132 may be separate elements that extend alongside one another along the length of the catheter body 106. In this embodiment, lacing member 112 and pusher bar 132 may be fixedly attached to each other such that proximal and distal movement of lacing member 112 or pusher bar 132 causes movement of the other of lacing member or pusher bar 132. Alternatively, the push rod 132 and the cinching member 112 may be configured to move independently of one another, and in such embodiments, the push rod 132 and cinching member 112 may be disposed coaxially or side-by-side with one another along the length of the catheter body 106.

Lacing member 112 may be used to facilitate re-nesting of device 102 after partial or full deployment of device 102. For example, after the device 102 has been deployed from the capsule 108, the clinician may move the push rod 132 in a distal direction until the distal end portion 118 of the cinching member 112 is exposed from the distal end of the capsule 108 (e.g., as shown in fig. 6A). As explained in further detail below, this distal movement of the lacing member 112 constrains the distal portion of the tether element 114 within the inner diameter of the lacing member 112, which can cause the ventricular end portion 134 of the device 102 to partially collapse or be constrained in the distal end 118 of the lacing member 112.

The tether element 114 is releasably coupled to the ventricular end portion 134 of the device 102 via a plurality of attachment features 142. As shown in fig. 6A and 6C, the attachment features 142 may be rings or eyelets spaced around the circumference of the device 102. In the illustrated embodiment, the device 102 includes six attachment features 142 and three tether elements 114 attached to the attachment features. Each tether element 114 passes through a first loop and a second loop circumferentially spaced from the first loop on a ventricular end portion 134 of the device 102 such that each tether element 114 extends across a portion (e.g., a diameter or chord) of the device 102. In other embodiments, each tether element 114 may be attached to only one attachment feature 142 or to more than two attachment features 142. In further embodiments, the attachment feature 142 may have a different configuration, such as a hook or a clasp, that releasably attaches the tether element 114 to the device 102. In still other embodiments, the delivery system 100 includes a different number of attachment features 142 and/or tether elements 114.

A tether element 114 extends through the catheter body 106 to a proximal portion 106b of the catheter body 106, where the tether element 114 is operably coupled to an actuator 116 of the handle assembly 110. In the illustrated embodiment, the tether element 114 extends through the cinching member 112 and into the push rod 132 to reach the proximal end portion 106b of the catheter body 106. As shown in fig. 6A, the distal end portion 132a of the push rod 132 may include a guide structure 136, such as an eyelet, channel, or loop, that routes the tether elements 114 into the opening of the push rod 132 and spaces the tether elements 114 from one another about the circumference of the distal end of the push rod 132. In other embodiments, the pusher 132 and/or the tightening member 112 may include additional guiding structures 136, which additional guiding structures 136 guide the tether element 114 along the length of the pusher 132 and/or tightening member 112. In further embodiments, the tether element 114 may extend along the exterior of the push rod 132 rather than through the push rod 132. In this embodiment, the lacing member 112 may have openings through which the tether element extends to the exterior of the push rod 132, or the lacing member 112 may be a separate tubular structure surrounding the push rod 132 that receives the tether element 114.

Referring to fig. 6B, each tether element 114 has a first end 138 secured at the handle assembly 110 and a movable second end 140 that can be pulled proximally and relaxed to collapse or re-expand the device 102. Each tether element 114 extends through the catheter body 106 from a fixed first end 138 to the device 102 where they are releasably coupled thereto and extend rearwardly through the catheter body 106 to a movable second end 140. The second end 140 of the tether element 114 can be operably coupled to the actuator 116 (fig. 6A) and the actuator can be manipulated in one manner (e.g., pulled or rotated in a first direction) to tension the tether element 114 and retract the tether element 114 proximally, and in another manner (e.g., pushed or rotated in a second direction) to slacken and advance the tether element 114 distally. In other embodiments, the second end 140 of each tether element 114 may be individually manipulated by a respective actuator to selectively pull and release the respective tether element 114.

During deployment of the device 102 at the native mitral valve, the end cap 128 can be moved distally and the capsule 108 can be moved into the deployed configuration (fig. 6A) using the push rod 132 and/or other suitable mechanical or hydraulic deployment mechanism to dislodge the device 102 from the housing 126 of the capsule 108. When the device 102 exits the housing 126, the device 102 expands and presses against tissue on the inner surface of the annulus of the mitral valve to secure the device 102 in the mitral valve. If the clinician chooses to reposition or remove the device 102, the cinching member 112 and tether element 114 may be used to partially or fully recapture the device 102 after full deployment from the bladder 108. More specifically, the clinician may move the cinching member 112 distally (as indicated by arrow 105) by manipulating the push rod 132 via the handle assembly 110 such that the cinching member 112 protrudes from the distal end of the bladder 108 (e.g., as shown in fig. 6A). This distal movement of the tightening member 112 restrains the tether element 114 within the tightening member 112, which in turn may tighten the ventricular end portion 134 of the device 102. The clinician may also move (e.g., rotate) the actuator 116 at the handle assembly 110 to pull the tether element 114 in a proximal direction. This may also cinch the ventricular end portion 134 of the device 102 and allow the clinician to move the delivery catheter 104 toward the distal end of the device 102.

As shown in fig. 6C, the interaction between the fastening member 112 and the proximal retraction of the tether element 114 may cause the ventricular end portion 134 of the device 102 to at least partially collapse to a diameter or outer dimension that allows the device 102 to be at least partially received within the distal end portion 118 of the tightening member 112. This pre-collapses the ventricular end portion 134 of the device 102 before re-nesting the device 102 within the capsule 108. The clinician may then move the lacing member 112 with the partially received therein in a proximal direction toward the capsule 108 so that the device 102 may be partially or fully re-nested within the capsule 108. Alternatively, the capsule 108 may be moved in a distal direction over the cinching end of the device 102 to at least partially recapture the device 102 within the capsule 108. In other embodiments, the bladder 108 can be moved distally while pulling the cinching member 112 with the device 102 proximally to begin resheathing. The partial contraction of the device 102 provided by the tether element 114 and the lacing member 112 allows the open end of the balloon 108 to easily receive the lacing end because the diameter of the laced ventricular end portion 134 is smaller than the diameter of the delivery balloon 108. To further recapture, the partial contraction of the device 102 provided by the tether element 114 and the cinching member 112 allows the bladder 108 to slide along the peripheral wall of the device 102 to further contract the device 102 and move it back into the nested, contained configuration in the bladder 108. As described in further detail below with reference to fig. 11-24, the device 102 itself may include a smooth and continuous outer wall that further facilitates such resheathing. This partial or complete recapping of the device 102 allows the clinician to reposition the device 102 or remove the device 102 in vivo after full deployment and after the device 102 has contacted the tissue of the native valve.

Once the device 102 has been fully deployed within the native valve at its final position, the tether element 114 may be detached from the device 102 to release the device 102 from the delivery system 100. For example, a first end 138 (fig. 6B) of tether element 114 may be released from its secured position by cutting first end 138 or otherwise releasing secured first end 138, and a second end 240 (fig. 6B) of tether element 114 may be pulled in a proximal direction (e.g., by rotating about a mandrel on actuator 116). When the second end 140 is retracted, the first end 138 is moved through the catheter body 106 through the attachment feature 142 of the device 102 and back into the catheter body 106 such that the tether element 114 is no longer connected to the device 102. In other embodiments, the tether element 114 may be detached from the device 102 using other suitable mechanisms, such as severing the tether at an area closer to the bladder 108. After the cinching member 114 is released from the device 102, the delivery system 100 is removed from the patient while the device 102 remains implanted at the native valve.

Fig. 7A is a side cross-sectional view of a delivery system 200 in accordance with another embodiment of the present technique, with a prosthetic heart valve device 202 ("device 202") in an expanded state, and fig. 7B is a side perspective view of the delivery system 200 of fig. 7A, with the device 202 in a partially contracted state. The delivery system 200 includes various features that are substantially similar to the features of the system 100 described above with reference to fig. 6A-6C. For example, the delivery system 200 includes a delivery capsule 208, the delivery capsule 208 having a housing 226 that retains the device 202 in a contained configuration, a cinching member 212 that extends at least partially through the capsule 208, and at least one tether element 214 that may be used to at least partially recapture the device 202 after the device 202 is fully deployed at a target location (e.g., the native mitral valve). The cross-sectional views of fig. 7A and 7B show only one tether element 214, but the delivery system 200 may include additional tether elements 214 disposed about the device 202 in a manner similar to the tether elements 214 shown. For example, delivery system 200 may include two, three, four, five, six, or more tether elements 214 spaced around the circumference of device 202. In the embodiment shown in fig. 7A and 7B, the cinching member 212 has a tubular structure that extends through the catheter body 206 to a proximal portion 206B of the catheter body 206 (for illustration purposes, a distal portion of the catheter body 206 is not shown), and houses the tether element(s) 214. At the proximal portion 206b of the catheter body 206, the first end 238 of each tether element 214 may be fixed and the second end 240 may be movable to allow the clinician to proximally retract the tether element(s) 214 and distally release the tether element(s) 214 to facilitate resheathing the device 202. For example, the second end 240 of the tether element 214 may be attached at a handle assembly (not shown; e.g., the handle assembly 110 shown in FIGS. 6A and 6C) to an actuator (not shown; e.g., the actuator 116 shown in FIGS. 6A and 6C) that may be used to move the tether element 214.

In the embodiment shown in fig. 7A and 7B, delivery system 200 includes a platform 250 operably coupled to bladder 208 to initiate deployment of device 202 from bladder 208. The platform 250 may include a distal end portion 252, such as a flange or base, configured to support the ventricular end portion 234 of the device 202 during deployment, and a shaft portion 254 extending proximally from the distal end portion 252 and at least partially through the capsule 208. In various embodiments, the platform 250 maintains the position of the device 202 at a desired target position relative to the longitudinal axis of the catheter body 206 as the balloon 208 is pulled in a proximal direction to dislodge the device 202. As shown in fig. 7A and 7B, the shaft portion 254 of the platform 250 extends through the tubular lacing member 212 to form a tether passageway 256 defined by an inner surface of the lacing member 212 and an outer surface of the platform 250 and is configured to receive the tether element(s) 214. Each tether element 214 extends from the first end 238, through a tether passageway 256, through one or more attachment features 242 on the ventricular end portion 234 of the device 202, and back through the tether passageway 256 to the proximal portion 206b of the catheter body 206 where the second end 240 can be operably coupled to an actuator for controlling the tether element 214. As shown in fig. 7A and 7B, the distal portion 252 of the platform 250 may also include one or more attachment elements 258, the attachment elements 258 releasably connecting the tether element(s) 214 to the platform 250. In the illustrated embodiment, the attachment element 258 is an eyelet or loop through which the tether element(s) 214 may pass. In other embodiments, the attachment element is a hook or other feature for releasably engaging tether element 214.

In certain embodiments, lacing member 212 and platform 250 are fixed relative to each other such that movement of platform 250 translates into movement of lacing member 212 and vice versa. During deployment, the device 202 expands from the capsule 208 as the housing 226 of the capsule 208 moves proximally and/or the platform 250 pushes the device 202 distally. After device 202 has been fully expanded, distal portion 218 of lacing member 212 can be moved such that distal portion 218 protrudes distally from bladder 208 and, due to the fixed relationship between platform 250 and lacing member 212, distal portion 252 of platform 250 protrudes distally from lacing member 212. In this fully deployed state, shown in fig. 7A, the clinician may pull on tether element 214 in a proximal direction to at least partially recapture device 202 to reposition or otherwise manipulate device 202. Proximal retraction of tether element 214 partially collapses ventricular end portion 234 of device 202 such that ventricular end portion 234 moves inwardly in the direction of arrow 207 (fig. 7A) toward distal end portion 252 of platform 250 and encircles (hug) platform 250. As shown in fig. 7B, proximal retraction of the tether element 214 may also move the device 202 in a proximal direction toward the cinching member 212 and wind the ventricular end portion 234 around the distal end portion 252 of the platform 250. In certain embodiments, the partially collapsed ventricular end portion 234 of the device 202 may be laced against an area between the platform 250 and the distal end portion 218 of the lacing member 212, or the ventricular end portion 234 may be at least partially received within the distal end portion 218 of the lacing member 212. In this embodiment, ventricular end portion 234 of device 202 is contracted to an inner diameter of lacing member 212 that is less than the diameter of bladder 208.

When the device 202 is in a partially collapsed state (fig. 7B), the clinician can move the cinching member 212 and/or platform 250 in a proximal direction to partially or fully recapture the device 202 in the capsule 208, and/or the clinician can move the capsule 208 in a distal direction over the cinching end of the device 202. The partially collapsed device 202 allows the open end of the capsule 208 to easily slide over the cinched end because the diameter of the cinched ventricular end portion 234 is smaller than the diameter of the delivery capsule 208. Further, the arrangement shown in fig. 7B, in which the ventricular end 234 of the device 202 is wrapped around or around the distal end portion 252 of the platform 250, allows the platform 250 to provide support for the collapsed portion of the device 202 during resheathing and is expected to enhance stability at the ventricular end portion 234 during resheathing. After the constricted ventricular end portion 234 has been received in the capsule 208, recapturing may continue by sliding the capsule 208 along the peripheral wall of the device 202 to further collapse the device 102 and move the device 102 back to its unexpanded state to its contained configuration in the capsule 208. The partially or fully encased device 202 may then be repositioned and redeployed at the desired location. After final deployment at the target site, the clinician may disengage tether element 214 from device 202 by severing secured first end 238 to release device 202 from delivery system 200 and remove delivery system 200 from the patient.

Fig. 8A is a partially cut-away isometric view of a delivery system 300 having a prosthetic heart valve device 302 ("device 302") in an expanded state, and fig. 8B is an enlarged side view of a tether element attachment site for the delivery system 300, in accordance with yet another embodiment of the present technique. Delivery system 300 includes various features that are substantially similar to features of delivery system 200 described above with reference to fig. 7A and 7B. For example, the delivery system 300 includes an elongate catheter body 306 ("catheter body 306"), a delivery bladder 308 carried by a distal portion 306a of the catheter body 306, a cinching member 312 extending at least partially through the bladder 308, and a platform 350 having a distal portion 352 and a shaft portion 354 extending through the cinching member 312. In the illustrated embodiment, lacing member 312 is attached to a distal region of shaft portion 354 of platform 350 such that platform 350 and lacing member 312 are fixed relative to each other. The platform 350 may be configured to move the capsule 308 between the stowed configuration and the deployed configuration (fig. 8A) to dislodge and recapture the device 302.

Referring to fig. 8A, the delivery system 300 further includes tether elements 314, the tether elements 314 extending along the length of the catheter body 306 and extending through a tether passageway 358 defined by the platform 350. Accordingly, the shaft portion 354 of the platform 350 may be a tubular structure. In other embodiments, the cinching member 312 extends alongside the longer length of the shaft portion 354 and/or has a tubular structure that defines a passage for receiving the tether element 314. The tether element 314 is releasably coupled to the attachment feature 342 at the ventricular end portion 334 of the device 302. The actuator 316 may be rotated (as indicated by arrow 309) to proximally retract the tether element 314, which in turn pulls the ventricular end portion 334 of the device 302 inward toward the distal end portion 352 of the platform 350 (as indicated by arrow 307) to partially collapse the device 302. In other embodiments, other suitable means may be used to manipulate the actuator 316 to retract and release the tether element 314. Similar to the delivery system 200 shown in fig. 7A and 7B, the partially collapsed device 302 may be wrapped around and/or around the distal portion 352 of the platform 350 to facilitate resheathing of the device 302 after full deployment.

As best shown in fig. 8B, the attachment feature 342 of the delivery system 300 is a hook 360 located at the ventricular end portion 334 of the device 302, and the tether element 314 forms a loop 362 extending around the hook 360. The hooks 360 may each have a one-way notch that allows the hook 360 to flex open to receive the tether element 314 and flex closed after insertion to prevent the tether element 314 from disengaging from the hook 360. In other embodiments, the delivery system 300 may include a hook 360 and an eyelet attachment structure as shown in fig. 6A-7B, or the hook 360 may be replaced with an eyelet attachment structure such that the tether element 314 passes through an eyelet.

Unlike the tether elements shown in fig. 6A-7B that extend through the prosthetic device between two or more attachment features, each tether element 314 of the delivery system 300 extends from the distal end portion 318 of the tightening member 312, wraps around a single hook 360, and extends back into the tether passageway 356 through the distal end portion 318 of the tightening member 312 to form a separate loop 362. For example, fig. 8C is a partially schematic isometric view of a tethering arrangement for the delivery system 300. As shown in fig. 8C, the loops 362 of the tether element 314 extend from the housing 326 of the capsule 308 and are deployed outwardly into a petal-like configuration, with the loops 362 arranged to engage corresponding attachment features 342 (e.g., hooks 360 of fig. 8A and 8B) positioned circumferentially around the device 302. Each loop 362 is defined by a single tether element 314 that extends from a fixed first end 338 at the proximal portion 306b of the catheter body 306 through the catheter body 306 to mate with an attachment feature 342 (fig. 8A) and back through the catheter body 306, wherein a second end 340 of the tether element 314 is attached to an actuator 316 (fig. 8A) that can be manipulated to retract the tether element 314 proximally. In the illustrated embodiment, the delivery system 300 includes nine loops 362, but in other embodiments, the delivery system 300 may also include less than or more than nine loops 362 that attach to one or more corresponding attachment features 342 (fig. 8A) on the ventricular end portion 334 of the device 302. When the device 302 is loaded in the capsule 308, the looped tether element 314 may be attached to the hook 360 and continue to engage the hook 360 until the clinician is ready to fully release the device 302 from the delivery system 300. After deployment and optional resheathing, tether element 314 may be disengaged from hook 360 by releasing the secured end of tether element 314 and pulling tether element 314 proximally until tether element 314 is no longer looped around hook 360.

Fig. 9A-9C are a series of views illustrating re-nesting of a device 302 using the delivery system 300 shown in fig. 8A-8C, in accordance with embodiments of the present technique. In fig. 9A, the device 302 has been fully deployed from the housing 326 of the capsule 308, and the tether element 314 maintains engagement with the device 302 when the device 302 is in a fully expanded state. The distal portion 318 of the lacing member 312 extends distally from the open bladder 308, and the distal portion 352 of the platform 350 protrudes distally from the bladder 308. As shown in fig. 9A, the distal portion 352 of the platform 350 includes a plurality of openings 364 through which the loops 362 of each tether element 314 extend such that each loop 362 may be attached to a corresponding hook 360 on the ventricular end portion 334 of the device 302. In other embodiments, the distal portion 352 of the platform 350 has a single opening at the distal-most end through which all of the tether elements 314 exit the tether passageway 358 of the platform 350.

Referring to fig. 9B, if the clinician chooses to re-nest the device 302, the tether element 314 may be retracted proximally using the actuator 316. This proximal retraction pulls the tether element 314 inward toward the platform 350 in the direction of arrow 307, which in turn tightens the ventricular end portion 334 of the device 302 so that it wraps around the distal end portion 352 of the platform 350. Then, as shown in fig. 9C, the capsule 308 can be moved in a distal direction (as indicated by arrow 311) to slide over the partially collapsed device 302 and at least partially recapture the device 302 to allow repositioning or removal of the device within the body. The constricted ventricular end portion 334 and the support provided by the platform 350 are intended to assist in re-nesting the device 302 after full deployment. After final deployment at the target site, the clinician may fully release the device 302 from the delivery system 300 by releasing (e.g., cutting) the first end 338 (fig. 8C) of the tether elements 314, and manipulating the actuator 316 to retract the tether elements 314 proximally until they disengage from the hooks 360 on the device 302.

Fig. 10 is a side isometric view of a portion of a delivery system 400 for a prosthetic heart valve device 402 ("device 402") constructed in accordance with another embodiment of the present technique. Delivery system 400 may include certain features substantially similar to features of delivery systems 100, 200, and 300 described above with reference to fig. 6A-9C. For example, the delivery system 400 includes at least one tether element 414 extending through an elongate catheter body (not shown), a delivery balloon 408, and a cinching member 412 at a distal portion of the catheter body. Tether element 414 has a fixed first end 438 and a second end 440, the first end 438 and the second end 440 being operably coupled to an actuator (not shown) that can be manipulated to retract tether element 414 proximally. As shown in fig. 10, the device 402 includes a permanently attached tether assembly 466 extending proximally from a ventricular end portion 434 of the device 402. The tether assembly 466 includes a plurality of arm members 468 that are fixedly attached at one end to the ventricular end portion 434 of the device 402 via a permanent attachment feature, such as a fastener or suture. The opposite end of the arm member 468 is attached to a mating feature 470, which mating feature 470 may comprise a loop or other structure through which the tether element 414 may pass. Arm member 468 may be made from metal or polymer wires, cables, or other suitable structures similar to tether elements 114, 214, and 314 described above.

The device 402 may be fully deployed (fig. 10) from the capsule 408 at the target site (e.g., the native mitral valve). The tether element 414 in conjunction with the permanent tether assembly 466 of the device 402 may then be used to facilitate partial or complete recapping of a fully deployed device 402. More specifically, an actuator (not shown; e.g., actuators 116, 216, and 316 described above) may be manipulated (e.g., twisted or pulled) to proximally retract tether element(s) 414. This pulls the ventricular end portion 434 of the device 402 toward the distal end portion 418 of the lacing member 412 and may partially collapse the ventricular end portion 434 of the device 402. When the distal end portion 418 of the cinch member 412 encounters the tether assembly 466 (via distal movement of the cinch member 412 or proximal movement of the device 402), the distal end portion 418 may slide along the tensioned arm member 468 and allow the ventricular end portion 434 of the device 402 to retract into the cinch member 412. Tensioned arm member 468 may serve as a track to guide device 402 into lacing member 412 and smoothly slide into lacing member 412. The bladder 408 may then be moved over the partially collapsed device 402 to partially or fully recapture the device 402. After final positioning of the device 402, the first end 438 of the tether element(s) 414 may be severed and passed through the mating feature 470 to disengage the device 402 from the delivery system 400. After the device 402 has been released from the delivery system 400, the tether assembly 466 may be used to recapture the device 402 and allow for subsequent resheathing.

Selected embodiments of prosthetic heart valve devices

The delivery systems 100, 200, 300, and 400 described above with reference to fig. 6A-10 may be configured to deliver a variety of prosthetic heart valve devices, such as prosthetic valve devices for replacing a mitral valve and/or other valves (e.g., a mitral valve or a tricuspid valve). Examples of these prosthetic heart valve devices, system components, and associated methods are described in this section with reference to fig. 11A-24. The particular elements, sub-structures, advantages, uses, and/or other features of the various embodiments described with reference to fig. 11A-24 may be interchanged, substituted, or otherwise constructed as appropriate. In addition, suitable elements of the embodiments described with reference to FIGS. 11A-24 may also be used as stand-alone and/or self-contained devices.

Fig. 11A is a side cross-sectional view and fig. 11B is a top view of a prosthetic heart valve device ("device") 1100 in accordance with an embodiment of the present technique. The device 1100 includes a valve support 1110, an anchor member 1120 attached to the valve support 1110, and a prosthetic valve assembly 1150 within the valve support 1110. Referring to fig. 11A, the valve support 1110 has an inflow region 1112 and an outflow region 1114. The prosthetic valve assembly 1150 is disposed within the valve support 1110 to allow blood to flow from the inflow region 1112 through the outflow region 1114 (arrow BF), but to prevent blood from flowing in a direction from the outflow region 1114 through the inflow region 1112.

In the embodiment shown in fig. 11A, the anchor member 1120 includes a base 1122 attached to the outflow region 1114 of the valve support 1110 and a plurality of arms 1124 projecting laterally outward from the base 1122. Anchor member 1120 also includes a fixation structure 1130 extending from arms 1124. The fixation structure 1130 may include a first portion 1132 and a second portion 1134. The first portion 1132 of the fixation structure 1130 can be, for example, an upstream region of the fixation structure 1130 that is spaced laterally outward from the inflow region 1112 of the valve support 1110 by a gap G in the deployed configuration as shown in fig. 11A. The second portion 1134 of the fixation structure 1130 may be the most downstream portion of the fixation structure 1130. The fixation structure 1130 may be a cylindrical ring (e.g., a right cylinder or a cone), and the outer surface of the fixation structure 1130 may define an annular mating surface configured to press outwardly against the native annulus of a heart valve (e.g., a mitral valve). The securing structure 1130 may also include a plurality of securing elements 1136, the securing elements 1136 projecting radially outward and angled toward the upstream direction. The securing elements 1136 may be, for example, barbs, hooks, or other elements that are only inclined in an upstream direction (e.g., a direction extending away from a downstream portion of the device 1100).

Still referring to fig. 11A, the anchor member 1120 has a smooth curve 1140 between the arms 1124 and the fixation structure 1130. For example, the second portion 1134 of the fixation structure 1130 extends from the arm 1124 at a smooth bend 1140. The arms 1124 and the fixation structure 1130 may be integrally formed from a continuous strut or support element such that the smooth curve 1140 is a curved portion of a continuous strut. In other embodiments, the smooth curve 1140 may be a separate component with respect to the arms 1124 or the fixation structure 1130. For example, the smooth bends 1140 may be attached to the arms 1124 and/or the fixation structures 1130 using welds, adhesives, or other techniques that form smooth connections. The smooth curve 1140 is configured such that the device 1100 can be recaptured in a capsule or other container after the device 1100 has been at least partially deployed.

The device 1100 may also include a first sealing member 1162 on the valve support 1110 and a second sealing member 1164 on the anchor member 1120. The first and second sealing members 1162, 1164 may be made of a flexible material, such as

Or other types of polymeric materials. The first sealing member 1162 may cover the inner and/or outer surfaces of the valve support 1110. In the embodiment shown in fig. 11A, the first sealing member 1162 is attached to the inner surface of the valve support 1110 and the prosthetic valve assembly 1150 is attached to the first sealing member 1162 and the commissure portions of the valve support 1110. A second sealing member 1164 is attached to an inner surface of the anchor member 1120. As a result, the outer annular mating surface of the fixation structure 1130 is not covered by the second sealing member 1164 such that the outer annular mating surface of the fixation structure 1130 directly contacts the tissue of the native annulus.

The device 1100 may also include an extension member 1170. The extension member 1170 may be an extension of the second seal member 1164 or may be a separate component attached to the second seal member 1164 and/or the first portion 1132 of the fixed structure 1130. The extension member 1170 may be a flexible member that flexes relative to the first portion 1132 of the fixation structure 1130 in the deployed state (fig. 11A). In operation, the extension member 1170 provides tactile feedback or visual indication (e.g., on an echocardiographic or fluoroscopic imaging system) to guide the device 1100 during implantation such that the device 1100 is at a desired height and centered relative to the native annulus. As described below, the extension member 1170 may include a support member, such as a wire or other structure, that is visible during implantation via fluoroscopy or other imaging techniques. For example, the support member may be a radiopaque wire.

Fig. 12A and 12B are cross-sectional views illustrating an example of the operation of the smooth bend 1140 between the arms 1124 and the fixation structure 1130 in the recapture device 1100 after partial deployment. Fig. 12A schematically shows the device 1100 in a delivery state loaded into a capsule 1700 of a delivery system, while fig. 12B schematically shows the device 1100 in a partially deployed state. Referring to fig. 12A, bladder 1700 has a housing 1702, a platform or support 1704, and a top 1706. In the delivery state shown in fig. 12A, the device 1100 is in a low-profile configuration suitable for delivery through a catheter or cannula to a target implantation site at a native heart valve.

Referring to fig. 12B, the housing 1702 of the capsule 1700 has been moved distally such that the extension member 1170, fixation structure 1130, and a portion of the arms 1124 have been released from the housing 1702 in a partially deployed state. This is useful for positioning the fixation structure 1130 at an appropriate height relative to the native annulus a such that the fixation structure 1130 expands radially outward into contact with the inner surface of the native annulus a. However, the device 1100 may need to be repositioned and/or removed from the patient after being partially deployed. To do so, the housing 1702 is retracted (arrow R) toward the stationary structure 1130. As the housing 1702 slides along the arms 1124, the smooth curve 1140 between the arms 1124 and the fixed structure 1130 allows the edge 1708 of the housing 1702 to slide over the smooth curve 1140 and thereby recapture the fixed structure 1130 and extension member 1170 within the housing 1702. The device 1100 may then be removed from the patient or redeployed in a better position relative to the native annulus a. Further aspects of prosthetic heart valve devices and their interaction with corresponding delivery devices in accordance with the present techniques are described below with reference to fig. 13-24.

Fig. 13 is a top isometric view of an example of a device 1100. In this embodiment, the valve support 1110 defines a first frame (e.g., an inner frame) and the fixation structure 1130 of the anchor member 1120 defines a second frame (e.g., an outer frame), each of the first and second frames including a plurality of structural elements. More specifically, the fixation structure 1130 includes structural elements 1137 arranged in diamond-shaped cells 1138, which structural elements 1137 together form an at least substantially cylindrical ring when freely and fully expanded as shown in fig. 13. The structural elements 1137 may be struts or other structural features formed from metal, polymer, or other suitable material that may be self-expanding or expanded by a balloon or other type of mechanical expander.

In several embodiments, the securing structure 1130 may be a generally cylindrical securing ring having outwardly facing mating surfaces. For example, in the embodiment shown in fig. 13, the outer surface of the structural element 1137 defines an annular mating surface configured to press outwardly against the native annulus in the deployed state. In the fully expanded state without any limitation, the walls of the fixation structure 1130 are at least substantially parallel to the walls of the valve support 1110. However, when the fixation structure 1130 is pressed radially outward against the inner surface of the native valve of the heart valve, the fixation structure 1130 may flex inward (arrow I) in the deployed state.

The embodiment of the device 1100 shown in fig. 13 includes a first sealing member 1162 lining the inner surface of the valve support 1110 and a second sealing member 1164 along the inner surface of the fixation structure 1130. The extension member 1170 has a flexible web 1172 (e.g., fabric) and support members 1174 (e.g., metal or polymer strands) attached to the flexible web 1172. The flexible web 1172 may extend from the second sealing member 1164 without a metal-to-metal connection between the securing structure 1130 and the support member 1174. For example, the extension member 1170 may be a continuation of the material of the second sealing member 1164. Thus, several embodiments of the extension member 1170 are malleable or floppy structures that can be easily flexed relative to the fixation structure 1130. Support member 1174 can have a variety of configurations and can be made from a variety of materials, such as a double serpentine structure made from nitinol.

Fig. 14 is a side view of the device 1100 shown in fig. 13, and fig. 15 is a bottom isometric view of the device. Referring to fig. 14, the arms 1124 extend radially outward from the base 1122 at an angle a selected to position the fixation structure 1130 radially outward from the valve support 1110 (fig. 13) a desired distance in the deployed state. The angle a is also selected to allow an edge 1708 (fig. 12B) of the delivery system housing 1702 to slide from the base 1122 toward the fixation structure 1130 during recapture. In many embodiments, the angle α is 15 ° to 75 °, or, more specifically, 15 ° to 60 °, or, more specifically, 30 ° to 45 °. The arms 1124 of the fixation structure 1130 and the structural element 1137 may be formed from the same struts (i.e., integrally with each other) such that the smooth curve 1140 is a continuous smooth transition from the arms 1124 to the structural element 1137. It is expected that this will enable the edge 1708 of the housing 1702 to slide more easily over the smooth curve 1140 (fig. 12B) in a manner that allows for recapturing the fixation structure 1130 in the housing 1702 of the bladder 1700. Further, by integrally forming arm 1124 and structural element 1137 with one another, damage to device 1100 at the interface between arm 1124 and structural element 1137 is inhibited, as compared to configurations in which arm 1124 and structural element 1137 are separate components and welded or otherwise fastened to one another.

Referring to fig. 14 and 15, the arms 1124 are also spaced apart from each other along their entire length from where they connect to the base portion 1122 through smooth bends 1140 (fig. 14) to the structural elements 1137 of the securing structure 1130. Thus, as the edge 1708 (fig. 12B) of the housing 1702 slides along the arms 1124 during recapture, the respective arms 1124 can easily flex. It is expected that this will reduce the likelihood of the edge 1708 of the housing 1702 catching on the arm 1124, and prevent the device 1100 from being recaptured in the housing 1702.

In one embodiment, the arms 1124 have a first length from the base 1122 to the smooth curve 1140 and the structural elements 1138 of the securing structures 1130 at each side of the cells 1137 (fig. 13) have a second length that is less than the first length of the arms 1124. The fixation structure 1130 is thus less flexible than the arms 1124. As a result, the fixation structure 1130 can be pressed outwardly against the native annulus with sufficient force to secure the device 1100 to the native annulus, while the arms 1124 are sufficiently flexible to fold inwardly when the device is recaptured in the delivery device.

In the embodiment shown in fig. 13-15, the arms 1124 and the structural elements 1137 are configured such that each arm 1124 and the two structural elements 1137 extending from each arm 1124 form a Y-shaped portion 1142 (fig. 15) of the anchor member 1120. In addition, the right side structural element 1137 of each Y-shaped portion 1142 is directly coupled to the left side structural element 1137 of the immediately adjacent Y-shaped portion 1142. It is contemplated that the Y-shaped portion 1142 and smooth curve 1140 further enhance the ability to slide the housing 1702 along the arms 1124 and securing structure 1130 during recapture.

Fig. 16 is a side view and fig. 17 is a bottom isometric view of a prosthetic heart valve device ("device") 1200 in accordance with another embodiment of the present technique. The device 1200 is shown without the extension member 1170 (fig. 13-15), but the device 1200 may additionally include the extension member 1170 described above. The device 1200 also includes an extension connection 1210 that protrudes from the base 1122 of the anchor member 1120. Alternatively, the extension connection 1210 can extend from the valve support 1110 (fig. 11A-15) in addition to or instead of extending from the base 1122 of the anchor member 1120. The extended connection 1210 may include a first strut 1212a attached to a portion of the base 1122 and a second strut 1212b attached to another portion of the base 1122. First and second struts 1212a, 1212b are configured to form a V-shaped structure in which they extend in a downstream direction toward each other and are connected to each other at the bottom of the V-shaped structure. The V-shaped configuration of the first and second struts 1212A, 1212b elongates the extension connection 1210 when the device 1200 is in a low-profile configuration within the bladder 1700 (fig. 12A) during delivery or during partial deployment. When the device 1200 is fully released from the bladder 1700 (fig. 12A), the extension connector 1210 shortens to avoid interfering with blood flow along the left ventricular outflow tract.

The extension connection 1210 further includes an attachment element 1214 configured to releasably engage a delivery device. The attachment elements 1214 may be T-bars or other elements that prevent the device 1200 from being released from the bladder 1700 (fig. 12A) of the delivery device until desired. For example, T-bar type attachment elements 1214 may prevent device 1200 from moving axially during deployment or partial deployment until housing 1702 (fig. 12A) moves beyond the portion of the delivery device that engages attachment elements 1214. When the outflow region of the valve support 1110 and the base 1122 of the anchor member 1120 are fully expanded to allow the device 1200 to be fully deployed, this causes the attachment elements 1214 to disengage from the capsule 1700 (fig. 12A).

Fig. 18 is a side view of the device 1200 in a partially deployed state, and fig. 19 is a bottom isometric view of the device 1200, with the device 1200 still being able to be recaptured in the housing 1702 of the delivery device 1700. Referring to fig. 18, the device 1200 is partially deployed with the fixation structure 1130 substantially expanded, but with the attachment elements 1214 (fig. 16) still retained within the bladder 1700. This is useful for determining the accuracy of the position of the device 1200 and allowing blood to flow through the functional replacement valve during implantation, while maintaining the ability to recapture the device 1200 in the event that the device 1200 needs to be repositioned or removed from the patient. In this partially deployed state, the elongated first and second struts 1212a, 1212b of the extended connection 1210 space the base 1122 of the anchor member 1120 and the outflow region of the valve support 1110 (fig. 11A) from the edge 1708 of the capsule 1700 by a gap G.

Referring to fig. 19, gap G enables blood to flow through the prosthetic valve assembly 1150 while the device 1200 is only partially deployed. As a result, the device 1200 can be partially deployed to determine (a) whether the device 1200 is properly positioned relative to the native heart valve anatomy, and (b) whether there is adequate blood flow through the prosthetic valve assembly 1150 while the device 1200 is still held by the delivery device 1700. Thus, if the device 1200 is not in a desired location and/or if the prosthetic valve is not functioning properly, the device 1200 can be recaptured. It is expected that this additional functionality will significantly enhance the ability to correctly place the device 1200 and assess whether the device 1200 is functioning as intended in vivo, while maintaining the ability to reposition the device 1200 to redeploy the device in a patient or remove the device 1200 from a patient.

Fig. 20 is an isometric view of a valve support 1300 in accordance with an embodiment of the present technique. The valve support 1300 can be an embodiment of the valve support 1110 described above with reference to fig. 11A-19. The valve support 1300 has an outflow region 1302, an inflow region 1304, a first row 1310 of first hexagonal cells 1312 at the outflow region 1302, and a second row 1320 of second hexagonal cells 1322 at the inflow region 1304. For purposes of illustration, the valve support shown in fig. 20 is inverted as compared to the valve support 1110 shown in fig. 11A-19, such that blood flows through the valve support 1300 in the direction of arrow BF. In a mitral valve application, the valve support 1300 would be positioned within the anchor member 1120 (fig. 11A) such that the inflow region 1304 would correspond to the orientation of the inflow region 1112 in fig. 11A and the outflow region 1302 would correspond to the orientation of the outflow region 1114 in fig. 11A.

Each first hexagonal cell 1312 includes a pair of first longitudinal supports 1314, a downstream vertex 1315, and an upstream vertex 1316. Each second hexagonal cell 1322 may include a pair of second longitudinal supports 1324, a downstream apex 1325, and an upstream apex 1326. The first and second rows 1310, 1312 of the first and second hexagonal cells 1312, 1322 are directly adjacent to each other. In the illustrated embodiment, the first longitudinal support 1314 extends directly from the downstream vertex 1325 of the second hexagonal cell 1322, and the second longitudinal support 1324 extends directly from the upstream vertex 1316 of the first hexagonal cell 1312. As a result, the first hexagonal cell 1312 is offset from the second hexagonal cell 1322 around the circumference of the valve support 1300 by half the cell width.

In the embodiment shown in fig. 20, the valve support 1300 includes a plurality of first struts 1331 at the outflow region 1302, a plurality of second struts 1332 at the inflow region 1304, and a plurality of third struts 1333 between the first struts 1331 and the second struts 1332. Each first strut 1331 extends from a downstream end of the first longitudinal support 1314, and pairs of the first struts 1331 are connected together to form first downstream V-shaped struts that define downstream vertices 1315 of the first hexagonal cells 1312. In a related sense, each second strut 1332 extends from an upstream end of the second longitudinal support portion 1324, and pairs of second struts 1332 are connected together to form second upstream V-shaped struts that define upstream vertices 1326 of the second hexagonal cells 1322. Each of the third struts 1333 has a downstream end connected to the upstream end of the first longitudinal support 1314, and each of the third struts 1333 has an upstream end connected to the downstream end of one of the second longitudinal supports 1324. Thus, the downstream ends of the third struts 1333 define a second downstream V-shaped strut arrangement that forms the downstream vertices 1325 of the second hexagonal cell 1322, and the upstream ends of the third struts 1333 define a first upstream V-shaped strut arrangement that forms the upstream vertices 1316 of the first hexagonal cell 1312. Thus, the third struts 1333 define both the first upstream V-shaped struts of the first hexagonal cell 1312 and the second downstream V-shaped struts of the second hexagonal cell 1322.

The first longitudinal support 1314 may include a plurality of holes 1336, and sutures may be passed through these holes 1336 to attach the prosthetic valve assembly and/or the sealing member. In the embodiment shown in fig. 20, only the first longitudinal support 1314 has a hole 1336. In yet other embodiments, the second longitudinal support portion 1324 may also include an aperture in addition to or in place of the aperture 1336 in the first longitudinal support portion 1314.

Fig. 21 is a side view of the valve support 1300, and fig. 22 is a bottom isometric view of the valve support 1300, with the first sealing member 1162 attached to the valve support 1300, and the prosthetic valve 1150 located within the valve support 1300. The first sealing member 1162 may be attached to the valve support 1300 by a plurality of sutures 1360 coupled to the first and second longitudinal support portions 1314, 1324. At least some of the sutures 1360 coupled to the first longitudinal support 1314 pass through the holes 1336 to further secure the first sealing member 1162 to the valve support 1300.

Referring to fig. 22, the prosthetic valve 1150 may be attached to the first sealing member 1162 and/or the first longitudinal support 1314 of the valve support 1300. For example, the commissure portions of the prosthetic valve 1150 can be aligned with the first longitudinal support 1314, and the sutures 1360 can be passed through the commissure portions of the prosthetic valve 1150 and the first sealing member 1162, with the commissure portions of the prosthetic valve 1150 being aligned with the first longitudinal support 1314. The inflow portion of the prosthetic valve 1150 can be sutured to the first sealing member 1162.

It is contemplated that the valve support 1300 shown in fig. 20-22 is well suited for use with the device 1200 described above with reference to fig. 16-19. More specifically, when the device 1200 is in the closed state, the first strut 1331 cooperates with the extended connection 1210 (fig. 16-19) of the device 1200 to separate the outflow portion of the prosthetic valve 1150 from the capsule 1700 (fig. 16-19). The first struts 1331 elongate when the valve support is fully expanded (e.g., at least partially housed in the capsule 1700) and shorten when the valve support 1300 is not fully expanded. This allows the outflow portion of the prosthetic valve 1150 to be further spaced apart from the capsule 1700 in the partially deployed state such that the prosthetic valve 1150 can be at least partially functional when the device 1200 (fig. 16-19) is in the partially deployed state. Thus, the valve support 1300 is expected to enhance the ability to assess whether the prosthetic valve 1150 is fully operational in a partially deployed state.

Fig. 23 and 24 are schematic side views of valve supports 1400 and 1500, respectively, in accordance with other embodiments of the present technique. Referring to fig. 23, the valve support 1400 includes a first row 1410 of first hexagonal cells 1412 and a second row 1420 of second hexagonal cells 1422. The valve 1400 may also include a first row of diamond-shaped cells 1430 extending from the first hexagonal cell 1412 and a second row of diamond-shaped cells 1440 extending from the second hexagonal cell 1422. The additional diamond-shaped cells are elongated in the low-profile state so they can space the prosthetic valve 1150 (shown schematically) further from the capsule of the delivery device. Referring to fig. 24, the valve support 1500 includes a first row 1510 of first hexagonal cells 1512 at the outflow region 1502 and a second row 1520 of second hexagonal cells 1522 at the inflow region 1504. The valve support 1500 is shaped such that the cross-sectional area of the intermediate region 1506 (between the inflow region 1502 and the outflow region 1504) is less than the cross-sectional area of the outflow region 1502 and/or the inflow region 1504. As such, the first row 1512 of the first hexagonal cell 1510 flares outward in a downstream direction, and the second row 1522 of the second hexagonal cell 1520 flares outward in an upstream direction.

Examples of the invention

Several aspects of the present technology are set forth in the following examples.

1. A delivery system for delivering a prosthetic heart valve device into a heart of a human patient, the delivery system comprising:

an elongate catheter body;

a capsule carried by the elongate catheter body and configured to move between (a) a stowed configuration for holding the prosthetic heart valve device and (b) a deployed configuration for at least partially deploying the prosthetic heart valve device;

a cinching member slidably disposed within at least a portion of a distal region of the bladder;

a plurality of tether elements extending through the cinching member and the catheter body to a proximal end thereof, wherein the tether elements are releasably coupled to the prosthetic heart valve; and

wherein proximal retraction of the tether element is configured to push at least a portion of the prosthetic heart valve device toward the distal end portion of the cinching member to recapture at least a portion of the prosthetic heart valve device and allow the prosthetic heart valve device to be repositioned relative to the native valve after the prosthetic heart valve device has contacted native valve tissue of the patient's heart.

2. The delivery system of example 1, wherein the tether element is releasably attached to a ventricular end of the prosthetic heart valve device.

3. The delivery system of examples 1 or 2, wherein the tether element is removably coupled to a hook element on a ventricular end of the prosthetic heart valve device.

4. The delivery system of example 1 or 2, wherein each of the tether elements extends through first and second loops on a ventricular end of the prosthetic heart valve device, and wherein the first and second loops are circumferentially spaced apart from each other on the ventricular end of the prosthetic heart valve device.

5. The delivery system of any of examples 1-4, further comprising:

a handle assembly located at a proximal portion of the elongate catheter body, the handle assembly having an actuator,

wherein each of the tether elements has a first end and a second end, wherein the first end is fixed and the second end is coupled to the actuator, and

wherein the actuator is configured to proximally retract and distally advance the tether element.

6. The delivery system of any of examples 1-5, further comprising a push rod extending through the catheter body and having a distal end portion coupled to the cinching member.

7. The delivery system of example 6, wherein the distal portion of the pushrod comprises a plurality of loops, and wherein the tether element extends through the loops and the pushrod.

8. The delivery system of any of examples 1-5, further comprising:

a distal platform movably positioned in the capsule, wherein the distal platform is configured to allow the prosthetic heart valve device to at least partially expand out of the capsule.

9. The delivery system of example 8, wherein the tether element extends through an eyelet on the distal platform and is removably coupled to a corresponding mating feature of the prosthetic heart valve.

10. The delivery system of example 8, wherein the distal platform and the cinching member are fixed relative to a handle assembly at the proximal portion of the catheter body.

11. The delivery system of any of examples 1-10, wherein the cinching member is axially movable relative to the bladder.

12. The delivery system of any of examples 1-11, wherein the cinching member is independently movable relative to the elongate catheter body and the bladder.

13. The delivery system of any of examples 1-12, wherein the capsule has a first diameter and the constricting member has a second diameter that is less than the first diameter.

14. The delivery system of any of examples 1-4, further comprising a handle assembly at a proximal portion of the elongate catheter body, the handle assembly having an actuator configured to pull and relax the tether element.

15. The delivery system of example 14, wherein the actuator comprises a rotary actuator mechanism at the handle assembly.

16. The delivery system of any of examples 1-15, wherein the plurality of tether elements comprises three tether elements.

17. The delivery system of any of examples 1-16, wherein proximal retraction of the tether element is configured to push at least a portion of the prosthetic heart valve device into the distal end portion of the cinching member to recapture at least a portion of the prosthetic heart valve device.

18. A delivery system, the delivery system comprising:

an elongate catheter body having a distal portion and a proximal portion;

a handle assembly located at the proximal portion of the elongate catheter body;

a delivery capsule coupled to the elongate catheter body and configured to move between a delivery arrangement for holding a prosthetic heart valve device and a deployment arrangement for deploying the prosthetic heart valve device at least partially into a heart of a human patient, wherein the capsule has a first diameter;

a cinching member slidably disposed within at least a portion of the delivery bladder and the distal region of the catheter body, wherein the cinching member has a second diameter that is less than the first diameter and is axially movable relative to the catheter body and the delivery bladder; and

a plurality of tether elements releasably coupled to the prosthetic heart valve, wherein the tether elements extend from the prosthetic heart valve device through the cinching member and the catheter body to the handle assembly,

wherein retraction of the tether element toward the handle assembly is configured to move a ventricular end of the prosthetic heart valve device from an at least partially deployed arrangement to a collapsed arrangement, a third diameter of the collapsed arrangement being less than the first diameter.

19. The delivery system of example 18, wherein the tether element is looped around a mating feature at a ventricular end of the prosthetic heart valve device.

20. The delivery system of example 18 or 19, wherein each tether element extends from the distal end portion of the cinch member and through at least first and second mating features on the ventricular end of the prosthetic heart valve device, and wherein the first and second mating features are circumferentially spaced apart from one another on the ventricular end of the prosthetic heart valve device.

21. The delivery system of any of examples 18-20, wherein the handle assembly comprises an actuator operably coupled to the tether, wherein the actuator is configured to retract the tether element proximally and advance the tether element distally.

22. The delivery system of any of examples 18-21, further comprising a platform slidably disposed in the delivery capsule, wherein the platform is positioned to allow the prosthetic heart valve device to at least partially expand out of the delivery capsule.

23. A method for delivering a prosthetic heart valve device to a native mitral valve of a human patient's heart, the method comprising:

positioning a delivery capsule of an elongate catheter body within a heart, the delivery capsule carrying the prosthetic heart valve device;

deploying the prosthetic heart valve device from the delivery capsule to allow radial expansion of the prosthetic heart valve device against tissue of the native mitral valve;

extending a distal portion of a lacing member beyond a distal end of the delivery capsule;

retracting a plurality of tether elements coupled to the prosthetic heart valve device via a handle assembly located at a proximal portion of the elongate catheter body, wherein the tether elements extend through the cinching member, and wherein retracting the tether elements at least partially constricts the prosthetic heart valve device to recapture at least a portion of the prosthetic heart valve device; and

repositioning the prosthetic heart valve device relative to the native mitral valve while at least partially encasing the prosthetic heart valve device.

24. The method of example 23, wherein retracting the tether element contracts a ventricular portion of the prosthetic heart valve device to a first diameter, the first diameter being less than an inner diameter of the delivery capsule.

25. The method of example 23 or 24, wherein retracting the tether element moves at least a ventricular portion of the prosthetic heart valve device into the distal portion of the constricting member.

26. The method of any of examples 23-25, wherein deploying the prosthetic heart valve device comprises: fully expanding the prosthetic heart valve device prior to retracting the tether element to at least partially recapture the prosthetic heart valve device.

27. The method of any one of examples 23-26, wherein:

deploying the prosthetic heart valve device from the delivery capsule comprises: sliding a platform in the delivery capsule toward a first configuration; and

retracting the plurality of tether elements allows a ventricular end portion of the prosthetic heart valve device to at least partially wrap around the platform.

28. The method of any of examples 23-27, further comprising releasing the tether element from the prosthetic heart valve device after fully deploying the prosthetic heart valve device.

29. The method of any of examples 23-28, wherein retracting the plurality of tether elements comprises rotating an actuator at the handle assembly.

30. The method of any of examples 23-28, further comprising manipulating an actuator of the handle assembly to pull and relax the tether element.

31. A delivery system for delivering a prosthetic heart valve device into a heart of a human patient, the delivery system comprising:

an elongate catheter body;

a capsule carried by the elongate catheter body and configured to move between (a) a stowed configuration for holding the prosthetic heart valve device and (b) a deployed configuration for at least partially deploying the prosthetic heart valve device;

a cinching member slidably disposed within at least a portion of a distal region of the bladder;

at least one tether element extending through the cinching member and the catheter body to a proximal end thereof, wherein the tether element is releasably coupled to the prosthetic heart valve;

a tether assembly fixedly attached to the prosthetic heart valve device, wherein the tether assembly comprises a plurality of arm members extending from a ventricular end portion of the prosthetic heart valve device and mating features coupled to the arm members, wherein the prosthetic features are releasably attached to the tether element; and

wherein proximal retraction of the tether element is configured to push at least a portion of the prosthetic heart valve device into the distal end portion of the cinching member to recapture at least a portion of the prosthetic heart valve device and allow the prosthetic heart valve device to be repositioned relative to the native valve after the prosthetic heart valve device has contacted native valve tissue of the patient's heart.

Conclusion

The above detailed description of embodiments of the technology is not intended to be exhaustive or to limit the technology to the precise form 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, while the steps are presented in a given order, alternative embodiments may perform the steps in a different order. The various embodiments described herein can also be combined to provide further embodiments.

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

Moreover, unless the word "or" is expressly limited to only one item, to the exclusion of other items from a list of two or more items, the use of "or" in the list is to be construed as including (a) any single item in the list, (b) all items in the list, or (c) any combination of items in the list. Furthermore, the term "comprising" is used throughout to mean including at least the feature(s) recited, such that any greater number of the same feature and/or other types of other features is not excluded. It should also be understood that specific embodiments have been described herein for purposes of illustration, but that various modifications may be made without deviating from the technology. Further, while advantages associated with certain embodiments of the technology have been described in the context of those embodiments, other embodiments may also exhibit such advantages, and not all embodiments need necessarily exhibit such advantages to fall within the scope of the technology. Accordingly, the present disclosure and associated techniques may encompass other embodiments not explicitly shown or described herein.