Patent Description:
The present application further incorporates the subject matter of (<NUM>) International Patent Application No. <CIT>, (<NUM>) International Patent Application No. <CIT>, (<NUM>) International Patent Application No. <CIT>, (<NUM>) International Patent Application No. <CIT>, and (<NUM>) <CIT>.

The present technology relates generally to systems for delivering prosthetic heart valve devices. In particular, several embodiments of the present technology are related to hydraulic systems for percutaneously delivering prosthetic heart valve devices into mitral valves and associated methods. The invention relates to a system for delivering a prosthetic heart valve device into a heart of a patient as defined in independent claims <NUM> and <NUM>.

Heart valves can be affected by several conditions. For example, mitral valves can be affected by mitral valve regurgitation, mitral valve prolapse and mitral valve stenosis. Mitral valve regurgitation is abnormal leaking of blood from the left ventricle into the left atrium caused by a disorder of the heart in which the leaflets of the mitral valve fail to coapt into apposition at peak contraction pressures. The mitral valve leaflets may not coapt sufficiently because heart diseases often cause dilation of the heart muscle, which in turn enlarges the native mitral valve annulus to the extent that the leaflets do not coapt during systole. Abnormal backflow can also occur when the papillary muscles are functionally compromised due to ischemia or other conditions. More specifically, as the left ventricle contracts during systole, the affected papillary muscles do not contract sufficiently to effect proper closure of the leaflets.

Mitral valve prolapse is a condition when the mitral leaflets bulge abnormally up in to the left atrium. This can cause irregular behavior of the mitral valve and lead to mitral valve regurgitation. The leaflets may prolapse and fail to coapt because the tendons connecting the papillary muscles to the inferior side of the mitral valve leaflets (chordae tendineae) may tear or stretch. Mitral valve stenosis is a narrowing of the mitral valve orifice that impedes filling of the left ventricle in diastole.

Mitral valve regurgitation is often treated using diuretics and/or vasodilators to reduce the amount of blood flowing back into the left atrium. Surgical approaches (open and intravascular) for either the repair or replacement of the valve have also been used to treat mitral valve regurgitation. For example, typical repair techniques involve cinching or resecting portions of the dilated annulus. Cinching, for example, includes implanting annular or peri-annular rings that are generally secured to the annulus or surrounding tissue. Other repair procedures suture or clip the valve leaflets into partial apposition with one another.

Alternatively, more invasive procedures replace the entire valve itself by implanting mechanical valves or biological tissue into the heart in place of the native mitral valve. These invasive procedures conventionally require large open thoracotomies and are thus very painful, have significant morbidity, and require long recovery periods. Moreover, with many repair and replacement procedures, the durability of the devices or improper sizing of annuloplasty rings or replacement valves may cause additional problems for the patient. Repair procedures also require a highly skilled cardiac surgeon because poorly or inaccurately placed sutures may affect the success of procedures.

Less invasive approaches to aortic valve replacement have been implemented in recent years. Examples of pre-assembled, percutaneous prosthetic valves include, e.g., the CoreValve Revalving° System from Medtronic/Corevalve Inc. (Irvine, CA, USA) and the Edwards-Sapien® Valve from Edwards Lifesciences (Irvine, CA, USA). Both valve systems include an expandable frame and a tri-leaflet bioprosthetic valve attached to the expandable frame. The aortic valve is substantially symmetric, circular, and has a muscular annulus. The expandable frames in aortic applications have a symmetric, circular shape at the aortic valve annulus 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 anatomy lends itself to an expandable frame housing a replacement valve since the aortic valve anatomy is substantially uniform, symmetric, and fairly muscular. Other heart valve anatomies, however, are not uniform, symmetric or sufficiently muscular, and thus transvascular aortic valve replacement devises may not be well suited for other types of heart valves.

<CIT> relates to a catheter system having a movable sheath.

<CIT> discloses a hydraulic catheter system for deployment of a heart valve.

Many aspects of the present disclosure can be better understood with reference to the following drawings. The components in the drawings are not necessarily to scale. Instead, emphasis is placed on illustrating clearly the principles of the present disclosure. Furthermore, components can be shown as transparent in certain views for clarity of illustration only and not to indicate that the illustrated component is necessarily transparent. The headings provided herein are for convenience only.

The present technology is generally directed to hydraulic systems for delivering prosthetic heart valve devices and associated methods. Specific details of several embodiments of the present technology are described herein with reference to <FIG>. Although many of the embodiments are described with respect to devices, systems, and methods for delivering prosthetic heart valve devices 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 useful for delivering prosthetics to other valves, such as the tricuspid valve or the aortic valve. 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 can have different configurations, components, and/or procedures than those shown or described herein. Moreover, a person of ordinary skill in the art will understand that embodiments of the present technology can have configurations, components, and/or procedures in addition to those shown or described herein and that these and other embodiments can be without several of the configurations, components, and/or procedures shown or described herein without deviating from the present technology.

With regard to the terms "distal" and "proximal" within this description, unless otherwise specified, the terms can reference relative positions of portions of a prosthetic valve device and/or an associated delivery device with reference to an operator and/or a location in the vasculature or heart. For example, in referring to a delivery catheter suitable to deliver and position various prosthetic valve devices described herein, "proximal" can refer to a position closer to the operator of the device or an incision into the vasculature, and "distal" can refer to a position that is more distant from the operator of the device or further from the incision along the vasculature (e.g., the end of the catheter). With respect to a prosthetic heart valve device, the terms "proximal" and "distal" can refer to the location of portions of the device with respect to the direction of blood flow. For example, proximal can refer to an upstream position or a location where blood flows into the device (e.g., inflow region), and distal can refer to a downstream position or a location where blood flows out of the device (e.g., outflow region).

Several embodiments of the present technology are directed to delivery systems and mitral valve replacement devices that address the unique challenges of percutaneously replacing native mitral valves and are well-suited to be recaptured in a percutaneous delivery device after being partially deployed for repositioning or removing the device. Compared to replacing aortic valves, percutaneous mitral valve replacement faces unique anatomical obstacles that render percutaneous mitral valve replacement significantly more challenging than aortic valve replacement. First, unlike relatively symmetric and uniform aortic valves, the mitral valve annulus has a non-circular D-shape or kidney-like shape, with a non-planar, saddle-like geometry often lacking symmetry. The complex and highly variable anatomy of mitral valves makes it difficult to design a mitral valve prosthesis that conforms well to the native mitral annulus of specific patients. As a result, the prosthesis may not fit well with the native leaflets and/or annulus, which can leave gaps that allows backflow of blood to occur. For example, placement of a cylindrical valve prosthesis in a native mitral valve may leave gaps in commissural regions of the native valve through which perivalvular leaks may occur.

Current prosthetic valves developed for percutaneous aortic valve replacement are unsuitable for use in 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 which support the prosthetic valve also contact the annulus or other surrounding tissue. These types of devices directly transfer the forces exerted by the tissue and blood as the heart contracts to the valve support and the prosthetic leaflets, which in turn distorts the valve support from its desired cylindrical shape. This is a concern because most cardiac replacement devices use tri-leaflet valves, which require a substantially symmetric, cylindrical support around the prosthetic valve for proper opening and closing of the three leaflets over years of life. As a result, when these devices are subject to movement and forces from the annulus and other surrounding tissues, the prostheses may be compressed and/or distorted causing the prosthetic leaflets to malfunction. Moreover, a diseased mitral annulus is much larger than any available prosthetic aortic valve. As the size of the valve increases, the forces on the valve leaflets increase dramatically, so simply increasing the size of an aortic prosthesis to the size of a dilated mitral valve annulus would require dramatically thicker, taller leaflets, and might not be feasible.

In addition to its irregular, complex shape, which changes size over the course of each heartbeat, the mitral valve annulus lacks a significant amount of radial support from surrounding tissue. Compared to aortic valves, which are completely surrounded by fibro-elastic tissue that provides sufficient support for anchoring a prosthetic valve, mitral valves are bound by muscular tissue on the outer wall only. The inner wall of the mitral valve anatomy is bound by a thin vessel wall separating the mitral valve annulus from the inferior portion of the aortic outflow tract. As a result, significant radial forces on the mitral annulus, such as those imparted by an expanding stent prostheses, could lead to collapse of the inferior portion of the aortic tract. Moreover, larger prostheses exert more force and expand to larger dimensions, which exacerbates this problem for mitral valve replacement applications.

The chordae tendineae of the left ventricle may also present an obstacle in deploying a mitral valve prosthesis. Unlike aortic valves, mitral valves have a maze of cordage under the leaflets in the left ventricle that restrict the movement and position of a deployment catheter and the replacement device during implantation. As a result, deploying, positioning and anchoring a valve replacement device on the ventricular side of the native mitral valve annulus is complicated.

Embodiments of the present technology provide systems, methods and apparatus to treat heart valves of the body, such as the mitral valve, that address the challenges associated with the anatomy of the mitral valve and provide for repositioning and removal of a partially deployed device. The apparatus and methods enable a percutaneous approach using a catheter delivered intravascularly through a vein or artery into the heart, or through a cannula inserted through the heart wall. For example, the apparatus and methods are particularly well-suited for trans-septal and trans-apical approaches, but can also be trans-atrial and direct aortic delivery of a prosthetic replacement valve to a target location in the heart. Additionally, the embodiments of the devices and methods as described herein can be combined with many known surgeries and procedures, such as known methods of accessing the valves of the heart (e.g., the mitral valve or triscuspid valve) with antegrade or retrograde approaches, and combinations thereof.

The systems and methods described herein facilitate controlled delivery of a prosthetic heart valve device using trans-apical or trans-septal delivery approaches and allow resheathing of the prosthetic heart valve device after partial deployment of the device to reposition and/or remove the device. The delivery systems can include two independent fluid chambers that are interchangeably filled with fluid and drained of fluid to initiate deployment and resheathing of the prosthetic device. This facilitates hydraulic control and power for both proximal and distal movement of a capsule housing that provides for controlled delivery of the prosthetic heart valve device and inhibits uncontrolled movement of the delivery system resulting from forces associated with expansion of the prosthetic heart valve device (e.g., axial jumping, self-ejection, etc.). In addition, the hydraulic delivery systems disclosed herein can inhibit longitudinal translation of the prosthetic heart valve device relative to the treatment site while the prosthetic heart valve device moves between the containment configuration and the deployment configuration. This allows the clinician to position the sheathed prosthetic heart valve device at the desired target site for deployment, and then deploy the device at that target site without needing to compensate for any axial movement caused by deployment.

To better understand the structure and operation of valve replacement devices in accordance with the present technology, it is helpful to first understand approaches for implanting the devices. The mitral valve or other type of atrioventricular valve can be accessed through the patient's vasculature in a percutaneous manner. By percutaneous it is meant that a location of the vasculature remote from the heart is accessed through the skin, typically using a surgical cut down procedure or a minimally invasive procedure, such as using needle access through, for example, the Seldinger technique. The ability to percutaneously access the remote 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 entry into the left atrium by crossing the inter-atrial septum (e.g., a trans-septal approach). Alternatively, access to the mitral valve can be retrograde where the left ventricle is entered through the aortic valve. Access to the mitral valve may also be achieved using a cannula via a trans-apical approach. Depending on the approach, the interventional tools and supporting catheter(s) may be advanced to the heart intravascularly and positioned adjacent the target cardiac valve in a variety of manners, as described herein.

<FIG> illustrates a stage of a trans-septal approach for implanting a valve replacement device. In a trans-septal approach, access is via the inferior vena cava IVC or superior vena cava SVC, through the right atrium RA, across the inter-atrial septum IAS, and into the left atrium LA above the mitral valve MV. As shown in <FIG>, a catheter <NUM> having a needle <NUM> moves from the inferior vena cava IVC into the right atrium RA. Once the catheter <NUM> reaches the anterior side of the inter-atrial septum IAS, the needle <NUM> advances so that it penetrates through the septum, for example at the fossa ovalis FO or the foramen ovale into the left atrium LA. At this point, a guidewire replaces the needle <NUM> and the catheter <NUM> is withdrawn.

<FIG> illustrates a subsequent stage of a trans-septal approach in which guidewire <NUM> and guide catheter <NUM> pass through the inter-atrial septum IAS. The guide catheter <NUM> provides access to the mitral valve for implanting a valve replacement device in accordance with the technology.

In an alternative antegrade approach (not shown), surgical access may be obtained through an intercostal incision, preferably without removing ribs, and a small puncture or incision may be made in the left atrial wall. A guide catheter passes through this puncture or incision directly into the left atrium, sealed by a purse string-suture.

The antegrade or trans-septal approach to the mitral valve, as described above, can be advantageous in many respects. For example, antegrade approaches will usually enable more precise and effective centering and stabilization of the guide catheter and/or prosthetic valve device. The antegrade approach may also reduce the risk of damaging the chordae tendinae or other subvalvular structures with a catheter or other interventional tool. Additionally, the antegrade approach may decrease risks associated with crossing the aortic valve as in retrograde approaches. This can be particularly relevant to patients with prosthetic aortic valves, which cannot be crossed at all or without substantial risk of damage.

<FIG> and <FIG> show examples of a retrograde approaches to access the mitral valve. Access to the mitral valve MV may be achieved from the aortic arch AA, across the aortic valve AV, and into the left ventricle LV below the mitral valve MV. The aortic arch AA may be accessed through a conventional femoral artery access route or through more direct approaches via the brachial artery, axillary artery, radial artery, or carotid artery. Such access may be achieved with the use of a guidewire <NUM>. Once in place, a guide catheter <NUM> may be tracked over the guidewire <NUM>. Alternatively, a surgical approach may be taken through an incision in the chest, preferably intercostally without removing ribs, and placing a guide catheter through a puncture in the aorta itself. The guide catheter <NUM> affords subsequent access to permit placement of the prosthetic valve device, as described in more detail herein. Retrograde approaches advantageously do not need a trans-septal puncture. Cardiologists also more commonly use retrograde approaches, and thus retrograde approaches are more familiar.

<FIG> shows a trans-apical approach via a trans-apical puncture. In this approach, access to the heart is via a thoracic incision, which can be a conventional open thoracotomy or sternotomy, or a smaller intercostal or sub-xyphoid incision or puncture. An access cannula is then placed through a puncture in the wall of the left ventricle at or near the apex of the heart. The catheters and prosthetic devices of the invention may then be introduced into the left ventricle through this access cannula. The trans-apical approach provides a shorter, straighter, and more direct path to the mitral or aortic valve. Further, because it does not involve intravascular access, the trans-apical approach does not require training in interventional cardiology to perform the catheterizations required in other percutaneous approaches.

<FIG> is an isometric view of a hydraulic system <NUM> ("system <NUM>") for delivering a prosthetic heart valve device configured in accordance with an embodiment of the present technology. The system <NUM> includes a catheter <NUM> having an elongated catheter body <NUM> ("catheter body <NUM>") and a delivery capsule <NUM>. The catheter body <NUM> can include a proximal portion 108a coupled to a hand held control unit <NUM> ("control unit <NUM>") and a distal portion 108b carrying the delivery capsule <NUM>. The delivery capsule <NUM> can be configured to contain a prosthetic heart valve device <NUM> (shown schematically in broken lines). The control unit <NUM> can provide steering capability (e.g., <NUM> degree rotation of the delivery capsule <NUM>, <NUM> degree rotation of the delivery capsule <NUM>, <NUM>-axis steering, <NUM>-axis steering, etc.) used to deliver the delivery capsule <NUM> to a target site (e.g., to a native mitral valve) and deploy the prosthetic heart valve device <NUM> at the target site. The catheter <NUM> can be configured to travel over a guidewire <NUM>, which can be used to guide the delivery capsule <NUM> into the native heart valve. The system <NUM> can also include a fluid assembly <NUM> configured to supply fluid to and receive fluid from the catheter <NUM> to hydraulically move the delivery capsule <NUM> and deploy the prosthetic heart valve device <NUM>.

The fluid assembly <NUM> includes a fluid source <NUM> and a fluid line <NUM> fluidically coupling the fluid source <NUM> to the catheter <NUM>. The fluid source <NUM> may contain a flowable substance (e.g., water, saline, etc.) in one or more reservoirs. The fluid line <NUM> can include one or more hoses, tubes, or other components (e.g., connectors, valves, etc.) through which the flowable substance can pass from the fluid source <NUM> to the catheter <NUM> and/or through which the flowable substance can drain from the catheter <NUM> to the fluid source <NUM>. In other embodiments, the fluid line <NUM> can deliver the flowable substance to the catheter <NUM> from a first reservoir of the fluid source <NUM> and drain the flowable substance from the catheter <NUM> to a separate reservoir. The fluid assembly <NUM> can also include one or more pressurization devices (e.g., a pump), fluid connectors, fittings, valves, and/or other fluidic components that facilitate moving the fluid to and/or from the fluid source <NUM>. As explained in further detail below, the movement of the flowable substance to and from the fluid assembly <NUM> can be used to deploy the prosthetic heart valve device <NUM> from the delivery capsule <NUM> and/or resheathe the prosthetic heart valve device <NUM> after at least partial deployment.

In certain embodiments, the fluid assembly <NUM> may comprise a controller <NUM> that controls the movement of fluid to and from the catheter <NUM>. The controller <NUM> can include, without limitation, one or more computers, central processing units, processing devices, microprocessors, digital signal processors (DSPs), and/or application-specific integrated circuits (ASICs). To store information, for example, the controller <NUM> can include one or more storage elements, such as volatile memory, non-volatile memory, read-only memory (ROM), and/or random access memory (RAM). The stored information can include, pumping programs, patient information, and/or other executable programs. The controller <NUM> can further include a manual input device (e.g., a keyboard, a touch screen, etc.) and/or an automated input device (e.g., a computer, a data storage device, servers, network, etc.). In still other embodiments, the controller <NUM> may include different features and/or have a different arrangement for controlling the flow of fluid into and out of the fluid source <NUM>.

The control unit <NUM> can include a control assembly <NUM> and a steering mechanism <NUM>. For example, the control assembly <NUM> can include rotational elements, such as a knob, that can be rotated to rotate the delivery capsule <NUM> about its longitudinal axis <NUM>. The control assembly <NUM> can also include features that allow a clinician to control the hydraulic deployment mechanisms of the delivery capsule <NUM> and/or the fluid assembly <NUM>. For example, the control assembly <NUM> can include buttons, levers, and/or other actuators that initiate unsheathing and/or resheathing the prosthetic heart valve device <NUM>. The steering mechanism <NUM> can be used to steer the catheter <NUM> through the anatomy by bending the distal portion 108b of the catheter body <NUM> about a transverse axis. In other embodiments, the control unit <NUM> may include additional and/or different features that facilitate delivering the prosthetic heart valve device <NUM> to the target site.

The delivery capsule <NUM> includes a housing <NUM> configured to carry the prosthetic heart valve device <NUM> in the containment configuration and, optionally, an end cap <NUM> that extends distally from the housing <NUM> and encloses the prosthetic heart valve device <NUM> in the housing <NUM>. The end cap <NUM> can have an opening <NUM> at its distal end through which the guidewire <NUM> can be threaded to allow for guidewire delivery to the target site. As shown in <FIG>, the end cap <NUM> can also have an atraumatic shape (e.g., a partially spherical shape, a frusto-conical shape, blunt configuration, rounded configuration, etc.) to facilitate atraumatic delivery of the delivery capsule <NUM> to the target site. In certain embodiments, the end cap <NUM> can also house a portion of the prosthetic heart valve device <NUM>. The housing <NUM> and/or the end cap <NUM> can be made of metal, polymers, plastic, composites, combinations thereof, or other materials capable of holding the prosthetic heart valve device <NUM>. As discussed in further detail below, the delivery capsule <NUM> is hydraulically driven via the control unit <NUM> and/or the fluid assembly <NUM> between a containment configuration for holding the prosthetic heart valve device <NUM> and a deployment configuration for at least partially deploying the prosthetic heart valve device <NUM> at the target site. The delivery capsule <NUM> also allows for resheathing of the prosthetic heart valve device <NUM> after it has been partially deployed.

<FIG> is a partially schematic illustration of a distal portion of the system <NUM> of <FIG> in the containment configuration positioned in a native mitral valve of a heart using a trans-apical delivery approach in accordance with embodiments of the present technology, and <FIG> is a partially schematic illustration of the system <NUM> in the deployment configuration. Referring to <FIG>, a guide catheter <NUM> can be positioned in a trans-apical opening <NUM> in the heart to provide access to the left ventricle LV, and the catheter <NUM> can extend through the guide catheter <NUM> such that the distal portion 108b of the catheter body <NUM> projects beyond the distal end of the guide catheter <NUM>. The delivery capsule <NUM> is then positioned between a posterior leaflet PL and an anterior leaflet AL of a mitral valve MV. Using the control unit <NUM> (<FIG>), the catheter body <NUM> can be moved in the superior direction (as indicated by arrow <NUM>), the inferior direction (as indicated by arrow <NUM>), and/or rotated along the longitudinal axis of the catheter body <NUM> to position the delivery capsule <NUM> at a desired location and orientation within the opening of the mitral valve MV.

Once at a target location, the delivery capsule <NUM> can be hydraulically driven from the containment configuration (<FIG>) towards the deployment configuration (<FIG>) to partially or fully deploy the prosthetic heart valve device <NUM> from the delivery capsule <NUM>. For example, as explained in further detail below, the delivery capsule <NUM> can be hydraulically driven towards the deployment configuration by supplying a flowable liquid to a chamber of the delivery capsule <NUM> while also removing a flowable liquid from a separate chamber of the delivery capsule <NUM>. The hydraulically controlled movement of the delivery capsule <NUM> is expected to reduce, limit, or substantially eliminate uncontrolled deployment of the prosthetic heart valve device <NUM> caused by forces associated with expansion of the prosthetic heart valve device <NUM>, such as jumping, self-ejection, and/or other types of uncontrolled movement. For example, the delivery capsule <NUM> is expected to inhibit or prevent translation of the prosthetic heart valve device <NUM> relative to the catheter body <NUM> while at least a portion of the prosthetic heart valve device <NUM> expands.

Referring to <FIG>, in trans-apical delivery approaches, the prosthetic heart valve device <NUM> is deployed from the delivery capsule <NUM> by drawing the housing <NUM> proximally (i.e., further into the left ventricle LV) and, optionally, moving the end cap <NUM> distally (i.e., further into the left atrium LA). As the prosthetic heart valve device <NUM> exits the housing <NUM>, the device <NUM> expands and presses against tissue on an inner surface of the annulus of the mitral valve MV to secure the device <NUM> in the mitral valve MV. The catheter <NUM> is also configured to partially or fully resheathe the prosthetic heart valve device <NUM> after partial deployment from the delivery capsule <NUM>. For example, the delivery capsule <NUM> can be hydraulically driven back towards the containment configuration by transferring fluid into one chamber of the delivery capsule <NUM> and removing fluid from another chamber of the delivery capsule <NUM> in an opposite manner as that used for deployment. This resheathing ability allows the clinician to reposition the prosthetic heart valve device <NUM>, in vivo, for redeployment within the mitral valve MV or remove the prosthetic heart valve device <NUM> from the patient after partial deployment. After full deployment of the prosthetic heart valve device <NUM>, the end cap <NUM> can be drawn through the deployed prosthetic heart valve device <NUM> to again close the delivery capsule <NUM> and draw the catheter <NUM> proximally through the guide catheter <NUM> for removal from the patient. After removing the catheter <NUM>, it can be cleaned and used to deliver additional prosthetic devices or it can be discarded.

<FIG> are partially schematic cross-sectional views of the delivery system <NUM> of <FIG> in the containment configuration (<FIG>) and the deployment configuration (<FIG>) in accordance with an embodiment of the present technology. As shown in <FIG>, the distal portion 108b of the elongated catheter body <NUM> carries the delivery capsule <NUM>. The delivery capsule <NUM> includes the housing <NUM> and a platform <NUM> that together define, at least in part, a first chamber 144a and a second chamber 144b (referred to collectively as "the chambers <NUM>"). The first chamber 144a and the second chamber 144b are fluidically sealed from each other and from a compartment <NUM> in the housing <NUM> that is configured to contain the prosthetic heart valve device <NUM>. The chambers <NUM> can be filled and drained to hydraulically drive the delivery capsule <NUM> between the containment configuration (<FIG>) for holding the prosthetic heart valve device <NUM> and the deployment configuration (<FIG>) for at least partially deploying the prosthetic heart valve device <NUM>. As shown in <FIG>, for example, the housing <NUM> of the delivery capsule <NUM> is urged proximally (in the direction of arrow <NUM>) towards the deployment configuration when fluid is at least partially drained from the first chamber 144a (as indicated by arrow <NUM>) while fluid is being delivered to the second chamber 144b (as indicated by arrow <NUM>). The proximal translation of the housing <NUM> allows the prosthetic heart valve device <NUM> to at least partially deploy from the housing <NUM> (<FIG>) and expand such that it may engage surrounding tissue of a native mitral valve. As shown in <FIG>, the housing <NUM> is urged distally back towards the containment configuration to resheathe at least a portion of the prosthetic heart valve device <NUM> when fluid is at least partially drained from the second chamber 144b (as indicated by arrow <NUM>) while fluid is being delivered into the first chamber 144b (as indicated by arrow <NUM>).

The platform <NUM> extends at least partially between the inner wall of the housing <NUM> to divide the housing <NUM> into the first chamber 144a and the second chamber 144b. The platform <NUM> can be integrally formed as a part of the housing <NUM>, such as an inwardly extending flange. Thus, the platform <NUM> can be made from the same material as the housing <NUM> (e.g., metal, polymers, plastic, composites, combinations thereof, or other). In other embodiments, the platform <NUM> may be a separate component that at least partially separates the two chambers <NUM> from each other.

As shown in <FIG>, a fluid delivery shaft <NUM> ("shaft <NUM>") extends through the catheter body <NUM>, into the housing <NUM> of the delivery capsule <NUM>, and through the platform <NUM>. At its proximal end (not shown), the shaft <NUM> is coupled to a fluid source (e.g., the fluid source <NUM> of <FIG>) and includes one or more fluid lines <NUM> (identified individually as a first line 152a and a second line 152b) that can deliver and/or drain fluid to and/or from the chambers <NUM>. The fluid lines <NUM> can be fluid passageways or lumens integrally formed within the shaft <NUM>, such as channels through the shaft itself, or the fluid lines <NUM> may be tubes or hoses positioned within one or more hollow regions of the shaft <NUM>. The first line 152a is in fluid communication with the first chamber 144a via a first opening 166a in the first fluid line 152a, and the second line 152b is in fluid communication with the second chamber 144b via a second opening 166b in the second fluid line 152b. In other embodiments, the first and second chambers 144a and 144b can be in fluid communication with more than one fluid line. For example, each chamber <NUM> may have a dedicated fluid delivery line and dedicated fluid drain line.

The shaft <NUM> can also include a first flange or pedestal 154a and a second flange or pedestal 154b (referred to together as "flanges <NUM>") that extend outwardly from the shaft <NUM> to define the proximal and distal ends of the first and second chambers 144a and 144b, respectively. Accordingly, the first chamber 144a is defined at a distal end by a proximal-facing surface of the platform <NUM>, at a proximal end by a distally-facing surface of the first flange 154a, and by the interior wall of the housing <NUM> extending therebetween. The second chamber 144b is defined at a proximal end by a distal-facing surface of the platform <NUM>, at a distal end by a proximally-facing surface of the second flange 154b, and by the interior wall of the housing <NUM> extending therebetween. The compartment <NUM> containing the prosthetic heart valve device <NUM> can be defined by a distal-facing surface of the second flange 154b, the end cap <NUM>, and the interior wall of the housing <NUM> extending therebetween. The shaft <NUM> and the flanges <NUM> can be integrally formed or separate components, and can be made from metal, polymers, plastic, composites, combinations thereof, and/or other suitable materials for containing fluids. The flanges <NUM> are fixed with respect to the shaft <NUM>. Sealing members <NUM> (identified individually as first through third sealing members 156a-c, respectively), such as O-rings, can be positioned around or within the flanges <NUM> and/or the platform <NUM> to fluidically seal the chambers <NUM> from other portions of the delivery capsule <NUM>. For example, the first and second sealing members 156a and 156b can be positioned in recesses of the corresponding first and second flanges 154a and 154b to fluidically seal the flanges <NUM> against the interior wall of the housing <NUM>, and the third sealing member 156c can be positioned within a recess of the platform <NUM> to fluidically seal the platform <NUM> to the shaft <NUM>. In other embodiments, the system <NUM> can include additional and/or differently arranged sealing members to fluidically seal the chambers <NUM>.

The fluid lines <NUM> are in fluid communication with a manifold <NUM> at a proximal portion of the system <NUM> and in communication with the fluid assembly <NUM> (<FIG>). The manifold <NUM> may be carried by the control unit <NUM> (<FIG>) or it may be integrated with the fluid assembly <NUM> (<FIG>). As shown in <FIG>, the manifold <NUM> can include a fluid delivery lumen <NUM> that bifurcates to allow for delivery of fluid to the first and second fluid lines 152a and 152b and a drain lumen <NUM> that bifurcates to allow for removal of fluid from the first and second fluid lines 152a and 152b. The delivery lumen <NUM> and the drain lumen <NUM> can be placed in fluid communication with the fluid source <NUM> (<FIG>) to allow fluid to move between the fluid source <NUM> to the chambers <NUM>. In other embodiments, each fluid line <NUM> can have a dedicated delivery lumen and a dedicated drain lumen, which are in turn fluidly coupled to separate fluid reservoirs in the fluid source <NUM> (<FIG>).

The manifold <NUM> further includes one or more valves <NUM> (referred to individually as a first valve 164a and a second valve 164b) that regulate fluid flow to and from the chambers <NUM>. The first valve 164a is in fluid communication with the first fluid line 152a, the delivery lumen <NUM> (or a portion thereof), and the drain line <NUM> (or a portion thereof) to regulate fluid to and from the first chamber 144a. The second valve 164b is in fluid communication with the second fluid line 152b, the delivery lumen <NUM> (or a portion thereof), and the drain line <NUM> (or a portion thereof) to regulate fluid to and from the second chamber 144b. The valves <NUM> can be three-way valves and/or other suitable valves for regulating fluid to and from the fluid lines <NUM>.

As shown in <FIG>, in the initial containment configuration, the first chamber 144a is at least partially filled with fluid and the second chamber 144b includes little to no fluid. To fully or partially unsheathe the prosthetic heart valve device <NUM>, the second valve 164b opens the second fluid line 152b and closes the drain line <NUM>. This allows fluid to flow from the delivery lumen <NUM>, through the second fluid line 152b, and into the second chamber 144b via the second opening 166b (as indicated by arrows <NUM>), while simultaneously blocking fluid from draining into the drain line <NUM>. As fluid is delivered to the second chamber 144b, fluid also drains from the first chamber 144a. To do this, the first valve 164a closes the first line 152a proximal to the fist valve 164a (i.e., such that the first line 152a is not in fluid communication with the delivery lumen <NUM>) and opens the drain lumen <NUM> so that fluid exits the first chamber 144a via the first opening 166a, travels along the first fluid line 152a, and into the drain lumen <NUM> via the first valve 164a (as indicated by arrows <NUM>). In certain embodiments, fluid is transferred to the second chamber 144b and from the first chamber 144a simultaneously and, optionally, in equal quantities so that the same amount of fluid transferred out of the first chamber 144a is transferred into the second chamber 144b. In other embodiments, different amounts of fluid are drained from and transferred to the chambers <NUM>. This concurrent transfer of fluid into the second chamber 144b while draining fluid from the first chamber 144a drives the housing <NUM> proximally in the direction of arrow <NUM>, which unsheathes the prosthetic heart valve device <NUM> and allows it to at least partially expand. As shown in <FIG>, this proximal movement of the housing <NUM> creates an open chamber <NUM> defined by the distal facing surface of the housing <NUM> and the proximal-facing surface of the flange 154a.

As shown in <FIG>, during deployment of the prosthetic heart valve device <NUM>, the delivery capsule <NUM> axially restrains an outflow portion of the prosthetic heart valve device <NUM> while an inflow portion of the prosthetic heart valve device <NUM> is deployed from the delivery capsule <NUM>. After at least partial deployment, the fluid chambers <NUM> can be pressurized and drained in an inverse manner to move the housing <NUM> distally (in the direction of arrow <NUM>) back toward the containment configuration and at least partially resheathe the prosthetic heart valve device <NUM>. For resheathing, the second valve 164b is placed in fluid communication with the drain lumen <NUM> and closes the second fluid line 152b proximal to the second valve 164b so that fluid drains from the second chamber 144b via the second opening 166b, through the second fluid line 152b, and into the drain lumen <NUM> (as indicated by arrows <NUM>). As fluid exits the second chamber 144b, fluid is also delivered to the first chamber 144a. That is, the first valve 164a is placed in fluid communication with the delivery lumen <NUM> to deliver fluid into the first chamber 144a via the first opening 166a of the first fluid line 152a (as indicated by arrows <NUM>). Again, the fluid can be transferred simultaneously and/or in equal proportions from the second chamber 144b and to the first chamber 144a. This transfer of fluid into the first chamber 144a and from the second chamber 144b drives the housing <NUM> distally in the direction of arrow <NUM> to controllably resheathe the prosthetic heart valve device <NUM> such that at least a portion of the prosthetic heart valve device <NUM> is again positioned within the compartment <NUM>. This partial or full resheathing of the prosthetic heart valve device <NUM> allows a clinician to reposition or remove the prosthetic heart valve device <NUM> after partial deployment. The hydraulic movement of the housing <NUM> is expected to provide controlled deployment and resheathing of the prosthetic heart valve device <NUM>.

As the delivery capsule <NUM> moves between the containment configuration and the deployment configuration, the housing <NUM> moves slideably with respect to the longitudinal axis of the shaft <NUM>, while the prosthetic heart valve device <NUM> at least substantially maintains its longitudinal position relative to the catheter body <NUM>. That is, the delivery capsule <NUM> can substantially prevent longitudinal translation of the prosthetic heart valve device <NUM> relative to the catheter body <NUM> while the prosthetic heart valve device <NUM> moves between the containment configuration (<FIG>) and the deployment configuration (<FIG>). This allows the clinician to position the sheathed prosthetic heart valve device <NUM> at the desired target site for deployment, and then deploy the device <NUM> at that target site without needing to compensate for any axial movement of the device <NUM> as it reaches full expansion (e.g., as would need to be taken into account if the device <NUM> was pushed distally from the housing <NUM>).

As further shown in <FIG>, the system <NUM> may also include a biasing device <NUM> that acts on the housing <NUM> to urge the housing <NUM> toward the containment configuration. The biasing device <NUM> compresses as the housing <NUM> moves to the deployment configuration (<FIG>) to apply more force on the housing <NUM> in a distal direction toward the containment configuration. In certain embodiments, the biasing device <NUM> acts continuously on the housing <NUM> urging it toward the containment configuration, and in other embodiments the biasing device <NUM> only acts on the housing <NUM> as it is compressed during deployment. In the illustrated embodiment, the biasing device <NUM> is a spring, but in other embodiments the biasing device can include other features that urge the housing <NUM> toward the containment configuration. The biasing device <NUM> limits or substantially prevents opening of the delivery capsule <NUM> attributable to the forces produced by the expanding prosthetic heart valve device <NUM>. For example, an unsheathed portion of the prosthetic heart valve device <NUM> can expand outwardly from the partially opened delivery capsule <NUM> while the biasing device <NUM> inhibits further opening of the delivery capsule <NUM>.

The system <NUM> shown in <FIG> allows for delivery of the prosthetic heart valve device <NUM> to a mitral valve from the left ventricle (e.g., via a trans-apical approach shown in <FIG> and <FIG>). For example, the hydraulic delivery mechanism moves the housing <NUM> proximally toward the distal portion 108b of the catheter body <NUM> to deploy the prosthetic heart valve device <NUM> (e.g., as shown in <FIG>), and once the prosthetic heart valve device <NUM> is fully deployed, the end cap <NUM> can be moved proximally from the left atrium and into the left ventricle through the deployed device <NUM>.

<FIG> are side cross-sectional views of a distal portion of a delivery system <NUM> for a prosthetic heart valve device <NUM> in a retained state (<FIG>) and in a fully deployed state (<FIG>) in accordance with another embodiment of the present technology. The delivery system <NUM> can include various features at least generally similar to the features of the system <NUM> described above with reference to <FIG>. For example, the delivery system <NUM> can be hydraulically driven by moving fluid to and from two separate chambers <NUM> (only the second chamber 144b shown in <FIG>) to move the housing <NUM> between deployment and containment configurations. The delivery system <NUM> also includes the fluid delivery shaft <NUM> with flanges <NUM> that define the outer bounds of the chambers <NUM>.

The delivery system <NUM> of <FIG> further includes an engagement device <NUM> that is configured to maintain engagement between the delivery capsule <NUM> and the prosthetic heart valve device <NUM> after the prosthetic heart valve device <NUM> has been at least partially expanded. The engagement device <NUM> includes a shaft <NUM> that extends through (e.g., coaxially within) or alongside at least a portion of the fluid delivery shaft <NUM> and is controllable by a clinician from a proximal portion of the delivery system <NUM> (e.g., via the control unit <NUM> of <FIG>). The shaft <NUM> can be a central or engagement shaft that includes a distal region <NUM> having a pedestal <NUM> with one or more engagement or attachment elements <NUM> that releasably mate with corresponding attachment features <NUM> extending from the outflow region of the prosthetic heart valve device <NUM>.

The attachment elements <NUM> can be recesses or pockets that retain correspondingly shaped attachment features <NUM> (e.g., pins or projections) on an outflow region of the prosthetic heart valve device <NUM>. For example, the attachment elements <NUM> can be circular pockets that receive eyelet-shaped attachment features <NUM> extending from the outflow region of the prosthetic heart valve device <NUM> and/or the attachment elements <NUM> can be T-shaped recesses that receive corresponding T-shaped attachment features <NUM> extending from the outflow region of the prosthetic heart valve device <NUM>.

<FIG> is a top view of the pedestal <NUM> illustrating one arrangement of the attachment elements <NUM>. The illustrated pedestal <NUM> includes four T-shaped recesses <NUM> spaced <NUM>° apart from each other around the periphery of the pedestal <NUM> and circular pockets <NUM> spaced between the T-shaped recesses <NUM>. The T-shaped recesses <NUM> may extend deeper into the pedestal <NUM> than the circular pockets <NUM> (e.g., as shown in <FIG>), or the attachment elements <NUM> can have similar depths. In other embodiments, the pedestal <NUM> has different quantities and/or arrangements of T-shaped recesses <NUM> and/or the circular pockets <NUM> across the face of the pedestal <NUM>. In further embodiments, the pedestal <NUM> can include differently shaped recesses and pockets that releasably mate with correspondingly-shaped attachment features on the prosthetic heart valve device <NUM>. In still further embodiments, the engagement device <NUM> includes other features that releasably attach the prosthetic heart valve device <NUM> to the delivery system <NUM> before final release from the delivery system <NUM>.

In the embodiment illustrated in <FIG>, the second flange 154b includes a projection <NUM> that forms a recess <NUM> facing the prosthetic heart valve device <NUM>, and the recess <NUM> at least partially receives the pedestal <NUM> to retain the attachment features <NUM> with the attachment elements <NUM>. The projection <NUM> may extend toward the prosthetic heart valve device <NUM> beyond the surface of the pedestal <NUM> positioned therein such that the projection <NUM> at least partially constrains an end region of the prosthetic heart valve device <NUM> before full deployment. In other embodiments, the second flange 154b does not include the projection <NUM>, and the pedestal <NUM> abuts an end surface of the second flange 154b and/or other outward-facing feature of the delivery capsule <NUM>.

In operation, a clinician moves the delivery capsule <NUM> to the target site (e.g., in a native mitral valve) and hydraulically moves the housing <NUM> to unsheathe and at least partially expand the prosthetic heart valve device <NUM>. When the prosthetic heart valve device <NUM> is substantially expanded (<FIG>), the engagement device <NUM> holds the prosthetic heart valve device <NUM> to the delivery system <NUM> in case the device <NUM> needs to be resheathed for repositioning or redeployment. This allows the clinician to again partially or fully resheathe the prosthetic heart valve device <NUM> to adjust its position or orientation with respect to the native valve. Referring to <FIG>, after the prosthetic heart valve device <NUM> is partially deployed at the appropriate location, the clinician can move the engagement shaft <NUM> in the direction of arrow <NUM> away from the remainder of the delivery capsule <NUM> and out of the recess <NUM> (e.g., in a distal direction when deployed trans-apically). This movement releases the mateably received attachment features <NUM> on the prosthetic heart valve device <NUM> from the corresponding attachment elements <NUM> to fully release the prosthetic heart valve device <NUM> from the delivery system <NUM>. For example, the expansion of the previously restrained proximal-most portion of the prosthetic heart valve device <NUM> (e.g., restrained by the projection <NUM> of the flange 154b) results in a force that disengages the attachment features <NUM> from the attachment elements <NUM> and allows the device <NUM> to fully expand. In other embodiments, the engagement shaft <NUM> can remain stationary with respect to the prosthetic heart valve device <NUM> and the delivery capsule <NUM> (e.g., the housing <NUM>, the flange 154b, etc.) can be moved away from the prosthetic heart valve device <NUM> (e.g., in a proximal direction when the device is deployed trans-apically) to disengage the attachment features <NUM> from the attachment elements <NUM>.

<FIG> are a series of partially schematic illustrations of a distal portion of a hydraulic delivery system <NUM> deploying a prosthetic a prosthetic heart valve device <NUM> within a native mitral valve of a heart using a trans-septal approach in accordance with further embodiments of the present technology. The hydraulic delivery system <NUM> can include certain features generally similar the delivery systems <NUM>, <NUM> described above with reference to <FIG>. For example, the delivery system <NUM> includes a catheter <NUM> having an elongated catheter body <NUM> and a delivery capsule <NUM> at a distal portion 308b of the catheter body <NUM>. The proximal portion of the catheter <NUM> can be coupled to a fluid system (e.g., the fluid assembly <NUM> of <FIG>) and/or a manifold (e.g., the manifold <NUM> of <FIG>) to hydraulically move the delivery capsule <NUM> between a containment configuration and a deployment configuration. The delivery system <NUM> facilitates trans-septal delivery of the prosthetic heart valve device <NUM> to the native mitral valve MV.

Referring to <FIG>, a puncture or opening <NUM> can be formed in an atrial region of a septum of the heart to access the left atrium LA. A guide catheter <NUM> can be positioned through the opening <NUM>, and a guidewire <NUM> can extend through the guide catheter <NUM>, through the mitral valve MV, and into the left ventricle LV. A delivery capsule <NUM> at a distal portion 308b of the elongated catheter body <NUM> can then be delivered to the left atrium LA from the guide catheter <NUM>, advanced along the guidewire <NUM>, and positioned at a target site between the posterior and anterior leaflets PL and AL of the mitral valve MV.

As shown in <FIG>, once at the target site in the mitral valve MV, the prosthetic heart valve device <NUM> can be deployed by removing a proximally positioned end cap <NUM> and moving a housing <NUM> of the delivery capsule <NUM> in a distal direction (i.e., downstream further into the left ventricle LV). In certain embodiments, fluid can be delivered and removed to/from chambers (not shown) of the delivery capsule <NUM> to hydraulically move the housing <NUM> toward the deployment configuration. This distal movement unsheathes the upstream or inflow portion of the prosthetic heart valve device <NUM> while the downstream or ventricular end of the prosthetic heart valve device <NUM> remains constrained within the housing <NUM>. The unsheathed inflow portion can expand outward to contact tissue of the mitral valve MV. If the clinician elects to adjust the positioning of the prosthetic heart valve device <NUM>, fluid can be delivered to and removed from the delivery capsule chambers in an opposite manner to hydraulically move the housing <NUM> toward the containment configuration and at least partially resheathe the prosthetic heart valve device <NUM>. After the deployed inflow portion of the prosthetic heart valve device <NUM> is appropriately seated in the mitral valve MV, fluid can again be delivered to and removed from the delivery capsule chambers to again move the housing <NUM> distally toward the deployment configuration. As shown in <FIG>, fluid can be delivered/removed until the housing <NUM> fully unsheathes the prosthetic heart valve device <NUM> and the prosthetic heart valve device <NUM> expands against the mitral valve MV. In the fully deployed state, the delivery capsule <NUM> can then be returned to the containment configuration (e.g., with the housing <NUM> and the end cap <NUM> joined together), pulled through the left atrium LA, and removed from the heart.

In other embodiments, the system <NUM> of <FIG> can be reconfigured to allow for deployment from the left atrium (e.g., via the trans-septal approach shown in <FIG>) in which case the housing <NUM> with the first and second chambers 144a and 144b has the opposite orientation shown in <FIG>. That is, the end cap <NUM> is positioned adjacent to the distal portion 108b of the catheter body <NUM> and the housing <NUM> is located distally from the end cap <NUM> with the shaft <NUM> extending through or adjacent to the device <NUM> to allow fluid delivery to the chambers <NUM>. To deploy the prosthetic heart valve device <NUM>, fluid is removed from the first fluid chamber 144a while fluid is delivered to the second fluid chamber 144b, which moves the housing <NUM> distally (further into the left ventricle) to at least partially unsheathe the prosthetic heart valve device <NUM>. To resheathe the prosthetic heart valve device <NUM>, fluid is removed from the second fluid chamber 144b while fluid is delivered to the first fluid chamber 144a, moving the housing <NUM> proximally (toward the catheter body <NUM>) toward the containment configuration.

<FIG> are enlarged, partially schematic cross-sectional views of a distal portion of the trans-septal delivery system <NUM> in a partially expanded deployment configuration (<FIG>) and a resheathing or containment configuration (<FIG>) in accordance with an embodiment of the present technology. As discussed above, the delivery system <NUM> includes the delivery capsule <NUM> coupled to the distal portion 308b of the catheter body <NUM>. The delivery capsule <NUM> includes the housing <NUM> and a platform <NUM> that define, at least in part, a first or deployment chamber 344a. The delivery system <NUM> further includes expandable member <NUM> coupled to the catheter body <NUM> and distal to the delivery capsule <NUM>. The interior of the expandable member <NUM> defines a second or resheathing chamber 344b. The expandable member <NUM> can be a balloon or other expandable component in which a fluid can be contained and removed. The delivery system <NUM> can also include sealing features <NUM> (identified individually as a first sealing features 356a and a second sealing feature 356b), such as O-rings, to fluidically seal the deployment chamber 344a from a containment compartment <NUM> (<FIG>) in the housing <NUM> that carries the prosthetic heart valve device <NUM> and the expandable member <NUM>. In other embodiments, the delivery system <NUM> can include additional sealing features for fluidically sealing the deployment chamber 344a and the resheathing chamber 344b.

As further shown in <FIG>, a fluid delivery shaft <NUM> extends through the housing <NUM> and into the expandable member <NUM>. The fluid delivery shaft <NUM> includes at least a first fluid line 352a in fluid communication with the deployment chamber 344a via a first opening 366a and a second fluid line 352b in fluid communication with the resheathing chamber 344b via a second opening 366b. The proximal portions of the fluid lines <NUM> can be in fluid communication with a manifold (not shown; e.g., the manifold <NUM> of <FIG>) and/or a fluid system (not shown; e.g., the fluid assembly <NUM> of <FIG>) to allow fluid to be delivered to and removed from the deployment and resheathing chambers 344a and 344b. In other embodiments, the first fluid line 352a and the second fluid line 352b can be separate components, such as two fluid delivery/removal shafts, one in fluid communication with the deployment chamber 344a and one in fluid communication with the resheathing chamber 344b. The fluid delivery shaft <NUM> can extend through the catheter body <NUM>, adjacent to the catheter body <NUM>. In other embodiments, the fluid delivery shaft <NUM> is omitted and the fluid lines <NUM> can be separate components that extend through the catheter body <NUM>.

In various embodiments, the delivery system <NUM> can further include a distal end cap <NUM> positioned distal to the expandable member <NUM> and coupled to the distal portion 308b of the catheter body <NUM> and/or the fluid delivery shaft <NUM>. The distal end cap <NUM> can be configured to seal the distal end of the expandable member <NUM> and/or may have an atraumatic shape (e.g., frusto-conical, partially spherical, etc.) to facilitate atraumatic delivery of the delivery capsule <NUM> to the target site. As shown in <FIG>, the distal end cap <NUM> can also include an opening <NUM> that allows for guidewire delivery of the delivery capsule <NUM> to the target site.

The delivery capsule <NUM> can be hydraulically driven between a containment configuration in which the prosthetic heart valve device <NUM> is held in the compartment <NUM> of the housing <NUM> and the deployment configuration in which at least a portion of the prosthetic heart valve device <NUM> expands from the compartment <NUM>. More specifically, in an initial containment state (e.g., as the delivery capsule <NUM> is delivered to the target site), the prosthetic heart valve device <NUM> is held in the compartment <NUM> of the housing <NUM> and the expandable member <NUM> is at least substantially empty (e.g., the configuration of the expandable member <NUM> shown in <FIG>). To begin deployment, fluid is delivered to the deployment chamber 344a via the first line 352a (e.g., as indicated by arrows <NUM> in <FIG>). Providing fluid to the deployment chamber 344a increases the pressure therein, thereby moving the housing <NUM> distally relative to the platform <NUM> and unsheathing the prosthetic heart valve device <NUM> (beginning with the atrial or inflow portion of the device <NUM>). This unsheathing mechanism at least substantially prevents translation of the prosthetic heart valve device <NUM> relative to the catheter body <NUM> and the surrounding anatomy to facilitate positioning and deployment of the device <NUM>.

As shown in <FIG>, the prosthetic heart valve device <NUM> can be at least partially resheathed after at least partial deployment. To resheathe the device <NUM>, fluid is drained or removed from deployment chamber 344a (as indicated by arrows <NUM>), while fluid is delivered to the expandable member <NUM> via the second line 352b (as indicated by arrows <NUM>). The expansion of the expandable member <NUM> urges the housing <NUM> towards the containment configuration such that the prosthetic heart valve device <NUM> is at least partially resheathed and again positioned at least partially in the compartment <NUM> of the housing <NUM> (<FIG>). Accordingly, the delivery system <NUM> provides for controlled, hydraulic delivery of the prosthetic heart valve device <NUM> via a trans-septal delivery approach and also inhibits translation of the prosthetic heart valve device <NUM> during deployment and resheathing to facilitate accurate delivery to the target site.

The hydraulic delivery systems <NUM>, <NUM>, <NUM> described above with reference to <FIG> can be configured to deliver various prosthetic heart valve devices, such as prosthetic valve devices for replacement of the mitral valve and/or other valves (e.g., a bicuspid or tricuspid valve) in the heart of the patient. Examples of these prosthetic heart valve devices, system components, and associated methods are described in this section with reference to <FIG>. Specific elements, substructures, advantages, uses, and/or other features of the embodiments described with reference to <FIG> can be suitably interchanged, substituted or otherwise configured with one another. Furthermore, suitable elements of the embodiments described with reference to <FIG> can be used as stand-alone and/or self-contained devices.

<FIG> is a side cross-sectional view and <FIG> is a top plan view of a prosthetic heart valve device ("device") <NUM> in accordance with an embodiment of the present technology. The device <NUM> includes a valve support <NUM>, an anchoring member <NUM> attached to the valve support <NUM>, and a prosthetic valve assembly <NUM> within the valve support <NUM>. Referring to <FIG>, the valve support <NUM> has an inflow region <NUM> and an outflow region <NUM>. The prosthetic valve assembly <NUM> is arranged within the valve support <NUM> to allow blood to flow from the inflow region <NUM> through the outflow region <NUM> (arrows BF), but prevent blood from flowing in a direction from the outflow region <NUM> through the inflow region <NUM>.

In the embodiment shown in <FIG>, the anchoring member <NUM> includes a base <NUM> attached to the outflow region <NUM> of the valve support <NUM> and a plurality of arms <NUM> projecting laterally outward from the base <NUM>. The anchoring member <NUM> also includes a fixation structure <NUM> extending from the arms <NUM>. The fixation structure <NUM> can include a first portion <NUM> and a second portion <NUM>. The first portion <NUM> of the fixation structure <NUM>, for example, can be an upstream region of the fixation structure <NUM> that, in a deployed configuration as shown in <FIG>, is spaced laterally outward apart from the inflow region <NUM> of the valve support <NUM> by a gap G. The second portion <NUM> of the fixation structure <NUM> can be a downstream-most portion of the fixation structure <NUM>. The fixation structure <NUM> can be a cylindrical ring (e.g., straight cylinder or conical), and the outer surface of the fixation structure <NUM> can define an annular engagement surface configured to press outwardly against a native annulus of a heart valve (e.g., a mitral valve). The fixation structure <NUM> can further include a plurality of fixation elements <NUM> that project radially outward and are inclined toward an upstream direction. The fixation elements <NUM>, for example, can be barbs, hooks, or other elements that are inclined only in the upstream direction (e.g., a direction extending away from the downstream portion of the device <NUM>).

Referring still to <FIG>, the anchoring member <NUM> has a smooth bend <NUM> between the arms <NUM> and the fixation structure <NUM>. For example, the second portion <NUM> of the fixation structure <NUM> extends from the arms <NUM> at the smooth bend <NUM>. The arms <NUM> and the fixation structure <NUM> can be formed integrally from a continuous strut or support element such that the smooth bend <NUM> is a bent portion of the continuous strut. In other embodiments, the smooth bend <NUM> can be a separate component with respect to either the arms <NUM> or the fixation structure <NUM>. For example, the smooth bend <NUM> can be attached to the arms <NUM> and/or the fixation structure <NUM> using a weld, adhesive or other technique that forms a smooth connection. The smooth bend <NUM> is configured such that the device <NUM> can be recaptured in a capsule or other container after the device <NUM> has been at least partially deployed.

The device <NUM> can further include a first sealing member <NUM> on the valve support <NUM> and a second sealing member <NUM> on the anchoring member <NUM>. The first and second sealing members <NUM>, <NUM> can be made from a flexible material, such as Dacron® or another type of polymeric material. The first sealing member <NUM> can cover the interior and/or exterior surfaces of the valve support <NUM>. In the embodiment illustrated in <FIG>, the first sealing member <NUM> is attached to the interior surface of the valve support <NUM>, and the prosthetic valve assembly <NUM> is attached to the first sealing member <NUM> and commissure portions of the valve support <NUM>. The second sealing member <NUM> is attached to the inner surface of the anchoring member <NUM>. As a result, the outer annular engagement surface of the fixation structure <NUM> is not covered by the second sealing member <NUM> so that the outer annular engagement surface of the fixation structure <NUM> directly contacts the tissue of the native annulus.

The device <NUM> can further include an extension member <NUM>. The extension member <NUM> can be an extension of the second sealing member <NUM>, or it can be a separate component attached to the second sealing member <NUM> and/or the first portion <NUM> of the fixation structure <NUM>. The extension member <NUM> can be a flexible member that, in a deployed state (<FIG>), flexes relative to the first portion <NUM> of the fixation structure <NUM>. In operation, the extension member <NUM> provides tactile feedback or a visual indicator (e.g., on echocardiographic or fluoroscopic imaging systems) to guide the device <NUM> during implantation such that the device <NUM> is located at a desired elevation and centered relative to the native annulus. As described below, the extension member <NUM> can include a support member, such as a metal wire or other structure, that can be visualized via fluoroscopy or other imaging techniques during implantation. For example, the support member can be a radiopaque wire.

<FIG> are cross-sectional views illustrating an example of the operation of the smooth bend <NUM> between the arms <NUM> and the fixation structure <NUM> in the recapturing of the device <NUM> after partial deployment. <FIG> schematically shows the device <NUM> loaded into a capsule <NUM> of a delivery system in a delivery state, and <FIG> schematically shows the device <NUM> in a partially deployed state. Referring to <FIG>, the capsule <NUM> has a housing <NUM>, a pedestal or support <NUM>, and a top <NUM>. In the delivery state shown in <FIG>, the device <NUM> is in a low-profile configuration suitable for delivery through a catheter or cannula to a target implant site at a native heart valve.

Referring to <FIG>, the housing <NUM> of the capsule <NUM> has been moved distally such that the extension member <NUM>, fixation structure <NUM> and a portion of the arms <NUM> have been released from the housing <NUM> in a partially deployed state. This is useful for locating the fixation structure <NUM> at the proper elevation relative to the native valve annulus A such that the fixation structure <NUM> expands radially outward into contact the inner surface of the native annulus A. However, the device <NUM> may need to be repositioned and/or removed from the patient after being partially deployed. To do this, the housing <NUM> is retracted (arrow R) back toward the fixation structure <NUM>. As the housing <NUM> slides along the arms <NUM>, the smooth bend <NUM> between the arms <NUM> and the fixation structure <NUM> allows the edge <NUM> of the housing <NUM> to slide over the smooth bend <NUM> and thereby recapture the fixation structure <NUM> and the extension member <NUM> within the housing <NUM>. The device <NUM> can then be removed from the patient or repositioned for redeployment at a better location relative to the native annulus A. Further aspects of prosthetic heart valve devices in accordance with the present technology and their interaction with corresponding delivery devices are described below with reference to <FIG>.

<FIG> is a top isometric view of an example of the device <NUM>. In this embodiment, the valve support <NUM> defines a first frame (e.g., an inner frame) and fixation structure <NUM> of the anchoring member <NUM> defines a second frame (e.g., an outer frame) that each include a plurality of structural elements. The fixation structure <NUM>, more specifically, includes structural elements <NUM> arranged in diamond-shaped cells <NUM> that together form at least a substantially cylindrical ring when freely and fully expanded as shown in <FIG>. The structural elements <NUM> can be struts or other structural features formed from metal, polymers, or other suitable materials that can self-expand or be expanded by a balloon or other type of mechanical expander.

In several embodiments, the fixation structure <NUM> can be a generally cylindrical fixation ring having an outwardly facing engagement surface. For example, in the embodiment shown in <FIG>, the outer surfaces of the structural elements <NUM> define an annular engagement surface configured to press outwardly against the native annulus in the deployed state. In a fully expanded state without any restrictions, the walls of the fixation structure <NUM> are at least substantially parallel to those of the valve support <NUM>. However, the fixation structure <NUM> can flex inwardly (arrow I) in the deployed state when it presses radially outwardly against the inner surface of the native annulus of a heart valve.

The embodiment of the device <NUM> shown in <FIG> includes the first sealing member <NUM> lining the interior surface of the valve support <NUM>, and the second sealing member <NUM> along the inner surface of the fixation structure <NUM>. The extension member <NUM> has a flexible web <NUM> (e.g., a fabric) and a support member <NUM> (e.g., metal or polymeric strands) attached to the flexible web <NUM>. The flexible web <NUM> can extend from the second sealing member <NUM> without a metal-to-metal connection between the fixation structure <NUM> and the support member <NUM>. For example, the extension member <NUM> can be a continuation of the material of the second sealing member <NUM>. Several embodiments of the extension member <NUM> are thus a malleable or floppy structure that can readily flex with respect to the fixation structure <NUM>. The support member <NUM> can have a variety of configurations and be made from a variety of materials, such as a double-serpentine structure made from Nitinol.

<FIG> is a side view and <FIG> is a bottom isometric view of the device <NUM> shown in <FIG>. Referring to <FIG>, the arms <NUM> extend radially outward from the base portion <NUM> at an angle α selected to position the fixation structure <NUM> radially outward from the valve support <NUM> (<FIG>) by a desired distance in a deployed state. The angle α is also selected to allow the edge <NUM> of the delivery system housing <NUM> (<FIG>) to slide from the base portion <NUM> toward the fixation structure <NUM> during recapture. In many embodiments, the angle α is <NUM>°- <NUM>°, or more specifically <NUM>°- <NUM>°, or still more specifically <NUM>°- <NUM>°. The arms <NUM> and the structural elements <NUM> of the fixation structure <NUM> can be formed from the same struts (i.e., formed integrally with each other) such that the smooth bend <NUM> is a continuous, smooth transition from the arms <NUM> to the structural elements <NUM>. This is expected to enable the edge <NUM> of the housing <NUM> to more readily slide over the smooth bend <NUM> in a manner that allows the fixation structure <NUM> to be recaptured in the housing <NUM> of the capsule <NUM> (<FIG>). Additionally, by integrally forming the arms <NUM> and the structural elements <NUM> with each other, it inhibits damage to the device <NUM> at a junction between the arms <NUM> and the structural elements <NUM> compared to a configuration in which the arms <NUM> and structural elements <NUM> are separate components and welded or otherwise fastened to each other.

Referring to <FIG> and <FIG>, the arms <NUM> are also separated from each other along their entire length from where they are connected to the base portion <NUM> through the smooth bend <NUM> (<FIG>) to the structural elements <NUM> of the fixation structure <NUM>. The individual arms <NUM> are thus able to readily flex as the edge <NUM> of the housing <NUM> (<FIG>) slides along the arms <NUM> during recapture. This is expected to reduce the likelihood that the edge <NUM> of the housing <NUM> will catch on the arms <NUM> and prevent the device <NUM> from being recaptured in the housing <NUM>.

In one embodiment, the arms <NUM> have a first length from the base <NUM> to the smooth bend <NUM>, and the structural elements <NUM> of the fixation structure <NUM> at each side of a cell <NUM> (<FIG>) have a second length that is less than the first length of the arms <NUM>. The fixation structure <NUM> is accordingly less flexible than the arms <NUM>. As a result, the fixation structure <NUM> is able to press outwardly against the native annulus with sufficient force to secure the device <NUM> to the native annulus, while the arms <NUM> are sufficiently flexible to fold inwardly when the device is recaptured in a delivery device.

In the embodiment illustrated in <FIG>, the arms <NUM> and the structural elements <NUM> are configured such that each arm <NUM> and the two structural elements <NUM> extending from each arm <NUM> formed a Y-shaped portion <NUM> (<FIG>) of the anchoring member <NUM>. Additionally, the right-hand structural element <NUM> of each Y-shaped portion <NUM> is coupled directly to a left-hand structural element <NUM> of an immediately adjacent Y-shaped portion <NUM>. The Y-shaped portions <NUM> and the smooth bends <NUM> are expected to further enhance the ability to slide the housing <NUM> along the arms <NUM> and the fixation structure <NUM> during recapture.

<FIG> is a side view and <FIG> is a bottom isometric view of a prosthetic heart valve device ("device") <NUM> in accordance with another embodiment of the present technology. The device <NUM> is shown without the extension member <NUM> (<FIG>), but the device <NUM> can further include the extension member <NUM> described above. The device <NUM> further includes extended connectors <NUM> projecting from the base <NUM> of the anchoring member <NUM>. Alternatively, the extended connectors <NUM> can extend from the valve support <NUM> (<FIG>) in addition to or in lieu of extending from the base <NUM> of the anchoring member <NUM>. The extended connectors <NUM> can include a first strut 1212a attached to one portion of the base <NUM> and a second strut 1212b attached to another portion of the base <NUM>. The first and second struts 1212a-b are configured to form a V-shaped structure in which they extend toward each other in a downstream direction and are connected to each other at the bottom of the V-shaped structure. The V-shaped structure of the first and second struts 1212a-b causes the extension connector <NUM> to elongate when the device <NUM> is in a low-profile configuration within the capsule <NUM> (<FIG>) during delivery or partial deployment. When the device <NUM> is fully released from the capsule <NUM> (<FIG>) the extension connectors <NUM> foreshorten to avoid interfering with blood flow along the left ventricular outflow tract.

The extended connectors <NUM> further include an attachment element <NUM> configured to releasably engage a delivery device. The attachment element <NUM> can be a T-bar or other element that prevents the device <NUM> from being released from the capsule <NUM> (<FIG>) of a delivery device until desired. For example, a T-bar type attachment element <NUM> can prevent the device <NUM> from moving axially during deployment or partial deployment until the housing <NUM> (<FIG>) moves beyond the portion of the delivery device engaged with the attachment elements <NUM>. This causes the attachment elements <NUM> to disengage from the capsule <NUM> (<FIG>) as the outflow region of the valve support <NUM> and the base <NUM> of the anchoring member <NUM> fully expand to allow for full deployment of the device <NUM>.

<FIG> is a side view and <FIG> is a bottom isometric view of the device <NUM> in a partially deployed state in which the device <NUM> is still capable of being recaptured in the housing <NUM> of the delivery device <NUM>. Referring to <FIG>, the device <NUM> is partially deployed with the fixation structure <NUM> substantially expanded but the attachment elements <NUM> (<FIG>) still retained within the capsule <NUM>. This is useful for determining the accuracy of the position of the device <NUM> and allowing blood to flow through the functioning replacement valve during implantation while retaining the ability to recapture the device <NUM> in case it needs to be repositioned or removed from the patient. In this state of partial deployment, the elongated first and second struts 1212a-b of the extended connectors <NUM> space the base <NUM> of the anchoring member <NUM> and the outflow region of the valve support <NUM> (<FIG>) apart from the edge <NUM> of the capsule <NUM> by a gap G.

Referring to <FIG>, the gap G enables blood to flow through the prosthetic valve assembly <NUM> while the device <NUM> is only partially deployed. As a result, the device <NUM> can be partially deployed to determine (a) whether the device <NUM> is positioned correctly with respect to the native heart valve anatomy and (b) whether proper blood flow passes through the prosthetic valve assembly <NUM> while the device <NUM> is still retained by the delivery system <NUM>. As such, the device <NUM> can be recaptured if it is not in the desired location and/or if the prosthetic valve is not functioning properly. This additional functionality is expected to significantly enhance the ability to properly position the device <NUM> and assess, in vivo, whether the device <NUM> will operate as intended, while retaining the ability to reposition the device <NUM> for redeployment or remove the device <NUM> from the patient.

<FIG> is an isometric view of a valve support <NUM> in accordance with an embodiment of the present technology. The valve support <NUM> can be an embodiment of the valve support <NUM> described above with respect to <FIG>. The valve support <NUM> has an outflow region <NUM>, an inflow region <NUM>, a first row <NUM> of first hexagonal cells <NUM> at the outflow region <NUM>, and a second row <NUM> of second hexagonal cells <NUM> at the inflow region <NUM>. For purposes of illustration, the valve support shown in <FIG> is inverted compared to the valve support <NUM> shown in <FIG> such that the blood flows through the valve support <NUM> in the direction of arrow BF. In mitral valve applications, the valve support <NUM> would be positioned within the anchoring member <NUM> (<FIG>) such that the inflow region <NUM> would correspond to orientation of the inflow region <NUM> in <FIG> and the outflow region <NUM> would correspond to the orientation of the outflow region <NUM> in <FIG>.

Each of the first hexagonal cells <NUM> includes a pair of first longitudinal supports <NUM>, a downstream apex <NUM>, and an upstream apex <NUM>. Each of the second hexagonal cells <NUM> can include a pair of second longitudinal supports <NUM>, a downstream apex <NUM>, and an upstream apex <NUM>. The first and second rows <NUM> and <NUM> of the first and second hexagonal cells <NUM> and <NUM> are directly adjacent to each other. In the illustrated embodiment, the first longitudinal supports <NUM> extend directly from the downstream apexes <NUM> of the second hexagonal cells <NUM>, and the second longitudinal supports <NUM> extend directly from the upstream apexes <NUM> of the first hexagonal cells <NUM>. As a result, the first hexagonal cells <NUM> are offset from the second hexagonal cells <NUM> around the circumference of the valve support <NUM> by half of the cell width.

In the embodiment illustrated in <FIG>, the valve support <NUM> includes a plurality of first struts <NUM> at the outflow region <NUM>, a plurality of second struts <NUM> at the inflow region <NUM>, and a plurality of third struts <NUM> between the first and second struts <NUM> and <NUM>. Each of the first struts <NUM> extends from a downstream end of the first longitudinal supports <NUM>, and pairs of the first struts <NUM> are connected together to form first downstream V-struts defining the downstream apexes <NUM> of the first hexagonal cells <NUM>. In a related sense, each of the second struts <NUM> extends from an upstream end of the second longitudinal supports <NUM>, and pairs of the second struts <NUM> are connected together to form second upstream V-struts defining the upstream apexes <NUM> of the second hexagonal cells <NUM>. Each of the third struts <NUM> has a downstream end connected to an upstream end of the first longitudinal supports <NUM>, and each of the third struts <NUM> has an upstream end connected to a downstream end of one of the second longitudinal supports <NUM>. The downstream ends of the third struts <NUM> accordingly define a second downstream V-strut arrangement that forms the downstream apexes <NUM> of the second hexagonal cells <NUM>, and the upstream ends of the third struts <NUM> define a first upstream V-strut arrangement that forms the upstream apexes <NUM> of the first hexagonal cells <NUM>. The third struts <NUM>, therefore, define both the first upstream V-struts of the first hexagonal cells <NUM> and the second downstream V-struts of the second hexagonal cells <NUM>.

The first longitudinal supports <NUM> can include a plurality of holes <NUM> through which sutures can pass to attach a prosthetic valve assembly and/or a sealing member. In the embodiment illustrated in <FIG>, only the first longitudinal supports <NUM> have holes <NUM>. However, in other embodiments the second longitudinal supports <NUM> can also include holes either in addition to or in lieu of the holes <NUM> in the first longitudinal supports <NUM>.

<FIG> is a side view and <FIG> is a bottom isometric view of the valve support <NUM> with a first sealing member <NUM> attached to the valve support <NUM> and a prosthetic valve <NUM> within the valve support <NUM>. The first sealing member <NUM> can be attached to the valve support <NUM> by a plurality of sutures <NUM> coupled to the first longitudinal supports <NUM> and the second longitudinal supports <NUM>. At least some of the sutures <NUM> coupled to the first longitudinal supports <NUM> pass through the holes <NUM> to further secure the first sealing member <NUM> to the valve support <NUM>.

Referring to <FIG>, the prosthetic valve <NUM> can be attached to the first sealing member <NUM> and/or the first longitudinal supports <NUM> of the valve support <NUM>. For example, the commissure portions of the prosthetic valve <NUM> can be aligned with the first longitudinal supports <NUM>, and the sutures <NUM> can pass through both the commissure portions of the prosthetic valve <NUM> and the first sealing member <NUM> where the commissure portions of the prosthetic valve <NUM> are aligned with a first longitudinal support <NUM>. The inflow portion of the prosthetic valve <NUM> can be sewn to the first sealing member <NUM>.

The valve support <NUM> illustrated in <FIG> is expected to be well suited for use with the device <NUM> described above with reference to <FIG>. More specifically, the first struts <NUM> cooperate with the extended connectors <NUM> (<FIG>) of the device <NUM> to separate the outflow portion of the prosthetic valve <NUM> from the capsule <NUM> (<FIG>) when the device <NUM> is in a partially deployed state. The first struts <NUM>, for example, elongate when the valve support <NUM> is not fully expanded (e.g., at least partially contained within the capsule <NUM>) and foreshorten when the valve support is fully expanded. This allows the outflow portion of the prosthetic valve <NUM> to be spaced further apart from the capsule <NUM> in a partially deployed state so that the prosthetic valve <NUM> can at least partially function when the device <NUM> (<FIG>) is in the partially deployed state. Therefore, the valve support <NUM> is expected to enhance the ability to assess whether the prosthetic valve <NUM> is fully operational in a partially deployed state.

<FIG> are schematic side views of valve supports <NUM> and <NUM>, respectively, in accordance with other embodiments of the present technology. Referring to <FIG>, the valve support <NUM> includes a first row <NUM> of first of hexagonal cells <NUM> and a second row <NUM> of second hexagonal cells <NUM>. The valve <NUM> can further include a first row <NUM> of diamond-shaped cells extending from the first hexagonal cells <NUM> and a second row <NUM> of diamond-shaped cells extending from the second hexagonal cells <NUM>. The additional diamond-shaped cells elongate in the low-profile state, and thus they can further space the prosthetic valve <NUM> (shown schematically) apart from a capsule of a delivery device. Referring to <FIG>, the valve support <NUM> includes a first row <NUM> of first hexagonal cells <NUM> at an outflow region <NUM> and a second row <NUM> of second hexagonal cells <NUM> at an inflow region <NUM>. The valve support <NUM> is shaped such that an intermediate region <NUM> (between the inflow and outflow regions <NUM> and <NUM>) has a smaller cross-sectional area than that of the outflow region <NUM> and/or the inflow region <NUM>. As such, the first row <NUM> of first hexagonal cells <NUM> flares outwardly in the downstream direction and the second row <NUM> of second hexagonal cells <NUM> flares outwardly in the upstream direction.

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

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

Claim 1:
A system (<NUM>) for delivering a prosthetic heart valve device into a heart of a patient, the system comprising:
an elongated catheter body (<NUM>);
a delivery capsule (<NUM>) carried by the elongated catheter body and configured to be hydraulically driven between a containment configuration for holding the prosthetic heart valve device and a deployment configuration for at least partially deploying the prosthetic heart valve device,
wherein the delivery capsule includes a housing (<NUM>) and a platform (<NUM>), and wherein-
the housing and the platform define, at least in part, a first chamber (144a) and a second chamber (144b),
at least a portion of the delivery capsule is urged towards the deployment configuration when fluid is at least partially drained from the first chamber while fluid is delivered into the second chamber, and
at least a portion of the delivery capsule is urged towards the containment configuration to resheathe at least a portion of the prosthetic heart valve device when fluid is at least partially drained from the second chamber and delivered into the first chamber; and
a biasing device (<NUM>) positioned along the catheter body and configured to urge the delivery capsule towards the containment configuration.