Patent ID: 12201523

DETAILED DESCRIPTION

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 toFIGS.1-25. 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).

Overview

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.

Access to the Mitral Valve

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.1illustrates 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 inFIG.1, a catheter1having a needle2moves from the inferior vena cava IVC into the right atrium RA. Once the catheter1reaches the anterior side of the inter-atrial septum IAS, the needle2advances 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 needle2and the catheter1is withdrawn.FIG.1also shows the tricuspid valve TV between the right atrium RA and the right ventricle.

FIG.2illustrates a subsequent stage of a trans-septal approach in which guidewire6and guide catheter4pass through the inter-atrial septum IAS. The guide catheter4provides 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.

FIGS.3and4show 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 guidewire6. Once in place, a guide catheter4may be tracked over the guidewire6. 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 catheter4affords 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.5shows 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.

Selected Embodiments of Delivery Systems for Prosthetic Heart Valve Devices

FIG.6is an isometric view of a hydraulic system100(“system100”) for delivering a prosthetic heart valve device configured in accordance with an embodiment of the present technology. The system100includes a catheter102having an elongated catheter body108(“catheter body108”) and a delivery capsule106. The catheter body108can include a proximal portion108acoupled to a hand held control unit104(“control unit104”) and a distal portion108bcarrying the delivery capsule106. The delivery capsule106can be configured to contain a prosthetic heart valve device110(shown schematically in broken lines). The control unit104can provide steering capability (e.g., 360 degree rotation of the delivery capsule106, 180 degree rotation of the delivery capsule106, 3-axis steering, 2-axis steering, etc.) used to deliver the delivery capsule106to a target site (e.g., to a native mitral valve) and deploy the prosthetic heart valve device110at the target site. The catheter102can be configured to travel over a guidewire120, which can be used to guide the delivery capsule106into the native heart valve. The system100can also include a fluid assembly112configured to supply fluid to and receive fluid from the catheter102to hydraulically move the delivery capsule106and deploy the prosthetic heart valve device110.

The fluid assembly112includes a fluid source114and a fluid line116fluidically coupling the fluid source114to the catheter102. The fluid source114may contain a flowable substance (e.g., water, saline, etc.) in one or more reservoirs. The fluid line116can include one or more hoses, tubes, or other components (e.g., connectors, valves, etc.) through which the flowable substance can pass from the fluid source114to the catheter102and/or through which the flowable substance can drain from the catheter102to the fluid source114. In other embodiments, the fluid line116can deliver the flowable substance to the catheter102from a first reservoir of the fluid source114and drain the flowable substance from the catheter102to a separate reservoir. The fluid assembly112can 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 source114. As explained in further detail below, the movement of the flowable substance to and from the fluid assembly112can be used to deploy the prosthetic heart valve device110from the delivery capsule106and/or resheathe the prosthetic heart valve device110after at least partial deployment.

In certain embodiments, the fluid assembly112may comprise a controller118that controls the movement of fluid to and from the catheter102. The controller118can 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 controller118can 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 controller118can 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 controller118may include different features and/or have a different arrangement for controlling the flow of fluid into and out of the fluid source114.

The control unit104can include a control assembly122and a steering mechanism124. For example, the control assembly122can include rotational elements, such as a knob, that can be rotated to rotate the delivery capsule106about its longitudinal axis107. The control assembly122can also include features that allow a clinician to control the hydraulic deployment mechanisms of the delivery capsule106and/or the fluid assembly112. For example, the control assembly122can include buttons, levers, and/or other actuators that initiate unsheathing and/or resheathing the prosthetic heart valve device110. The steering mechanism124can be used to steer the catheter102through the anatomy by bending the distal portion108bof the catheter body108about a transverse axis. In other embodiments, the control unit104may include additional and/or different features that facilitate delivering the prosthetic heart valve device110to the target site.

The delivery capsule106includes a housing126configured to carry the prosthetic heart valve device110in the containment configuration and, optionally, an end cap128that extends distally from the housing126and encloses the prosthetic heart valve device110in the housing126. The end cap128can have an opening130at its distal end through which the guidewire120can be threaded to allow for guidewire delivery to the target site. As shown inFIG.6, the end cap128can 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 capsule106to the target site. In certain embodiments, the end cap128can also house a portion of the prosthetic heart valve device110. The housing126and/or the end cap128can be made of metal, polymers, plastic, composites, combinations thereof, or other materials capable of holding the prosthetic heart valve device110. As discussed in further detail below, the delivery capsule106is hydraulically driven via the control unit104and/or the fluid assembly112between a containment configuration for holding the prosthetic heart valve device110and a deployment configuration for at least partially deploying the prosthetic heart valve device110at the target site. The delivery capsule106also allows for resheathing of the prosthetic heart valve device110after it has been partially deployed.

FIG.7Ais a partially schematic illustration of a distal portion of the system100ofFIG.6in 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, andFIG.7Bis a partially schematic illustration of the system100in the deployment configuration. Referring toFIG.7A, a guide catheter140can be positioned in a trans-apical opening141in the heart to provide access to the left ventricle LV, and the catheter102can extend through the guide catheter140such that the distal portion108bof the catheter body108projects beyond the distal end of the guide catheter140. The delivery capsule106is then positioned between a posterior leaflet PL and an anterior leaflet AL of a mitral valve MV. Using the control unit104(FIG.6), the catheter body108can be moved in the superior direction (as indicated by arrow149), the inferior direction (as indicated by arrow151), and/or rotated along the longitudinal axis of the catheter body108to position the delivery capsule106at a desired location and orientation within the opening of the mitral valve MV.

Once at a target location, the delivery capsule106can be hydraulically driven from the containment configuration (FIG.7A) towards the deployment configuration (FIG.7B) to partially or fully deploy the prosthetic heart valve device110from the delivery capsule106. For example, as explained in further detail below, the delivery capsule106can be hydraulically driven towards the deployment configuration by supplying a flowable liquid to a chamber of the delivery capsule106while also removing a flowable liquid from a separate chamber of the delivery capsule106. The hydraulically controlled movement of the delivery capsule106is expected to reduce, limit, or substantially eliminate uncontrolled deployment of the prosthetic heart valve device110caused by forces associated with expansion of the prosthetic heart valve device110, such as jumping, self-ejection, and/or other types of uncontrolled movement. For example, the delivery capsule106is expected to inhibit or prevent translation of the prosthetic heart valve device110relative to the catheter body108while at least a portion of the prosthetic heart valve device110expands.

Referring toFIG.7B, in trans-apical delivery approaches, the prosthetic heart valve device110is deployed from the delivery capsule106by drawing the housing126proximally (i.e., further into the left ventricle LV) and, optionally, moving the end cap128distally (i.e., further into the left atrium LA). As the prosthetic heart valve device110exits the housing126, the device110expands and presses against tissue on an inner surface of the annulus of the mitral valve MV to secure the device110in the mitral valve MV. The catheter102is also configured to partially or fully resheathe the prosthetic heart valve device110after partial deployment from the delivery capsule106. For example, the delivery capsule106can be hydraulically driven back towards the containment configuration by transferring fluid into one chamber of the delivery capsule106and removing fluid from another chamber of the delivery capsule106in an opposite manner as that used for deployment. This resheathing ability allows the clinician to reposition the prosthetic heart valve device110, in vivo, for redeployment within the mitral valve MV or remove the prosthetic heart valve device110from the patient after partial deployment. After full deployment of the prosthetic heart valve device110, the end cap128can be drawn through the deployed prosthetic heart valve device110to again close the delivery capsule106and draw the catheter102proximally through the guide catheter140for removal from the patient. After removing the catheter102, it can be cleaned and used to deliver additional prosthetic devices or it can be discarded.

FIGS.8A and8Bare partially schematic cross-sectional views of the delivery system100ofFIG.6in the containment configuration (FIG.8A) and the deployment configuration (FIG.8B) in accordance with an embodiment of the present technology. As shown inFIGS.8A and8B, the distal portion108bof the elongated catheter body108carries the delivery capsule106. The delivery capsule106includes the housing126and a platform142that together define, at least in part, a first chamber144aand a second chamber144b(referred to collectively as “the chambers144”). The first chamber144aand the second chamber144bare fluidically sealed from each other and from a compartment146in the housing126that is configured to contain the prosthetic heart valve device110. The chambers144can be filled and drained to hydraulically drive the delivery capsule106between the containment configuration (FIG.8A) for holding the prosthetic heart valve device110and the deployment configuration (FIG.8B) for at least partially deploying the prosthetic heart valve device100. As shown inFIG.8A, for example, the housing126of the delivery capsule106is urged proximally (in the direction of arrow153) towards the deployment configuration when fluid is at least partially drained from the first chamber144a(as indicated by arrow159) while fluid is being delivered to the second chamber144b(as indicated by arrow157). The proximal translation of the housing126allows the prosthetic heart valve device110to at least partially deploy from the housing126(FIG.8B) and expand such that it may engage surrounding tissue of a native mitral valve. As shown inFIG.8B, the housing126is urged distally back towards the containment configuration to resheathe at least a portion of the prosthetic heart valve device110when fluid is at least partially drained from the second chamber144b(as indicated by arrow161) while fluid is being delivered into the first chamber144b(as indicated by arrow163).

The platform142extends at least partially between the inner wall of the housing126to divide the housing126into the first chamber144aand the second chamber144b. The platform142can be integrally formed as a part of the housing126, such as an inwardly extending flange. Thus, the platform142can be made from the same material as the housing126(e.g., metal, polymers, plastic, composites, combinations thereof, or other). In other embodiments, the platform142may be a separate component that at least partially separates the two chambers144from each other.

As shown inFIGS.8A and8B, a fluid delivery shaft148(“shaft148”) extends through the catheter body108, into the housing126of the delivery capsule106, and through the platform142. At its proximal end (not shown), the shaft148is coupled to a fluid source (e.g., the fluid source114ofFIG.6) and includes one or more fluid lines152(identified individually as a first line152aand a second line152b) that can deliver and/or drain fluid to and/or from the chambers144. The fluid lines152can be fluid passageways or lumens integrally formed within the shaft148, such as channels through the shaft itself, or the fluid lines152may be tubes or hoses positioned within one or more hollow regions of the shaft148. The first line152ais in fluid communication with the first chamber144avia a first opening166ain the first fluid line152a, and the second line152bis in fluid communication with the second chamber144bvia a second opening166bin the second fluid line152b. In other embodiments, the first and second chambers144aand144bcan be in fluid communication with more than one fluid line. For example, each chamber144may have a dedicated fluid delivery line and dedicated fluid drain line.

The shaft148can also include a first flange or pedestal154aand a second flange or pedestal154b(referred to together as “flanges154”) that extend outwardly from the shaft148to define the proximal and distal ends of the first and second chambers144aand144b, respectively. Accordingly, the first chamber144ais defined at a distal end by a proximal-facing surface of the platform142, at a proximal end by a distally-facing surface of the first flange154a, and by the interior wall of the housing126extending therebetween. The second chamber144bis defined at a proximal end by a distal-facing surface of the platform142, at a distal end by a proximally-facing surface of the second flange154b, and by the interior wall of the housing126extending therebetween. The compartment146containing the prosthetic heart valve device110can be defined by a distal-facing surface of the second flange154b, the end cap128, and the interior wall of the housing126extending therebetween. The shaft148and the flanges154can 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 flanges148are fixed with respect to the shaft148. Sealing members156(identified individually as first through third sealing members156a-c, respectively), such as O-rings, can be positioned around or within the flanges154and/or the platform142to fluidically seal the chambers144from other portions of the delivery capsule106. For example, the first and second sealing members156aand156bcan be positioned in recesses of the corresponding first and second flanges154aand154bto fluidically seal the flanges154against the interior wall of the housing126, and the third sealing member156ccan be positioned within a recess of the platform142to fluidically seal the platform142to the shaft148. In other embodiments, the system100can include additional and/or differently arranged sealing members to fluidically seal the chambers144.

The fluid lines152are in fluid communication with a manifold158at a proximal portion of the system100and in communication with the fluid assembly112(FIG.6). The manifold158may be carried by the control unit104(FIG.6) or it may be integrated with the fluid assembly112(FIG.6). As shown inFIGS.8A and8B, the manifold158can include a fluid delivery lumen160that bifurcates to allow for delivery of fluid to the first and second fluid lines152aand152band a drain lumen162that bifurcates to allow for removal of fluid from the first and second fluid lines152aand152b. The delivery lumen160and the drain lumen162can be placed in fluid communication with the fluid source114(FIG.6) to allow fluid to move between the fluid source114to the chambers144. In other embodiments, each fluid line152can have a dedicated delivery lumen and a dedicated drain lumen, which are in turn fluidly coupled to separate fluid reservoirs in the fluid source114(FIG.6).

The manifold158further includes one or more valves164(referred to individually as a first valve164aand a second valve164b) that regulate fluid flow to and from the chambers144. The first valve164ais in fluid communication with the first fluid line152a, the delivery lumen160(or a portion thereof), and the drain line162(or a portion thereof) to regulate fluid to and from the first chamber144a. The second valve164bis in fluid communication with the second fluid line152b, the delivery lumen160(or a portion thereof), and the drain line162(or a portion thereof) to regulate fluid to and from the second chamber144b. The valves164can be three-way valves and/or other suitable valves for regulating fluid to and from the fluid lines152.

As shown inFIG.8A, in the initial containment configuration, the first chamber144ais at least partially filled with fluid and the second chamber144bincludes little to no fluid. To fully or partially unsheathe the prosthetic heart valve device110, the second valve164bopens the second fluid line152band closes the drain line162. This allows fluid to flow from the delivery lumen160, through the second fluid line152b, and into the second chamber144bvia the second opening166b(as indicated by arrows157), while simultaneously blocking fluid from draining into the drain line162. As fluid is delivered to the second chamber144b, fluid also drains from the first chamber144a. To do this, the first valve164acloses the first line152aproximal to the first valve164a(i.e., such that the first line152ais not in fluid communication with the delivery lumen160) and opens the drain lumen162so that fluid exits the first chamber144avia the first opening166a, travels along the first fluid line152a, and into the drain lumen162via the first valve164a(as indicated by arrows159). In certain embodiments, fluid is transferred to the second chamber144band from the first chamber144asimultaneously and, optionally, in equal quantities so that the same amount of fluid transferred out of the first chamber144ais transferred into the second chamber144b. In other embodiments, different amounts of fluid are drained from and transferred to the chambers144. This concurrent transfer of fluid into the second chamber144bwhile draining fluid from the first chamber144adrives the housing126proximally in the direction of arrow153, which unsheathes the prosthetic heart valve device110and allows it to at least partially expand. As shown inFIG.8B, this proximal movement of the housing126creates an open chamber170defined by the distal facing surface of the housing126and the proximal-facing surface of the flange154a.

As shown inFIG.8B, during deployment of the prosthetic heart valve device110, the delivery capsule106axially restrains an outflow portion of the prosthetic heart valve device110while an inflow portion of the prosthetic heart valve device110is deployed from the delivery capsule106. After at least partial deployment, the fluid chambers144can be pressurized and drained in an inverse manner to move the housing126distally (in the direction of arrow155) back toward the containment configuration and at least partially resheathe the prosthetic heart valve device110. For resheathing, the second valve164bis placed in fluid communication with the drain lumen162and closes the second fluid line152bproximal to the second valve164bso that fluid drains from the second chamber144bvia the second opening166b, through the second fluid line152b, and into the drain lumen162(as indicated by arrows161). As fluid exits the second chamber144b, fluid is also delivered to the first chamber144a. That is, the first valve164ais placed in fluid communication with the delivery lumen160to deliver fluid into the first chamber144avia the first opening166aof the first fluid line152a(as indicated by arrows163). Again, the fluid can be transferred simultaneously and/or in equal proportions from the second chamber144band to the first chamber144a. This transfer of fluid into the first chamber144aand from the second chamber144bdrives the housing126distally in the direction of arrow155to controllably resheathe the prosthetic heart valve device110such that at least a portion of the prosthetic heart valve device110is again positioned within the compartment146. This partial or full resheathing of the prosthetic heart valve device110allows a clinician to reposition or remove the prosthetic heart valve device110after partial deployment. The hydraulic movement of the housing126is expected to provide controlled deployment and resheathing of the prosthetic heart valve device110.

As the delivery capsule106moves between the containment configuration and the deployment configuration, the housing126moves slideably with respect to the longitudinal axis of the shaft148, while the prosthetic heart valve device110at least substantially maintains its longitudinal position relative to the catheter body108. That is, the delivery capsule106can substantially prevent longitudinal translation of the prosthetic heart valve device110relative to the catheter body108while the prosthetic heart valve device110moves between the containment configuration (FIG.8A) and the deployment configuration (FIG.8B). This allows the clinician to position the sheathed prosthetic heart valve device110at the desired target site for deployment, and then deploy the device110at that target site without needing to compensate for any axial movement of the device110as it reaches full expansion (e.g., as would need to be taken into account if the device110was pushed distally from the housing126).

As further shown inFIGS.8A and8B, the system100may also include a biasing device168that acts on the housing126to urge the housing126toward the containment configuration. The biasing device168compresses as the housing126moves to the deployment configuration (FIG.8B) to apply more force on the housing126in a distal direction toward the containment configuration. In certain embodiments, the biasing device168acts continuously on the housing126urging it toward the containment configuration, and in other embodiments the biasing device168only acts on the housing126as it is compressed during deployment. In the illustrated embodiment, the biasing device168is a spring, but in other embodiments the biasing device can include other features that urge the housing126toward the containment configuration. The biasing device168limits or substantially prevents opening of the delivery capsule106attributable to the forces produced by the expanding prosthetic heart valve device110. For example, an unsheathed portion of the prosthetic heart valve device110can expand outwardly from the partially opened delivery capsule106while the biasing device168inhibits further opening of the delivery capsule106.

The system100shown inFIGS.8A and8Ballows for delivery of the prosthetic heart valve device110to a mitral valve from the left ventricle (e.g., via a trans-apical approach shown inFIGS.7A and7B). For example, the hydraulic delivery mechanism moves the housing126proximally toward the distal portion108bof the catheter body108to deploy the prosthetic heart valve device110(e.g., as shown inFIG.7A), and once the prosthetic heart valve device110is fully deployed, the end cap128can be moved proximally from the left atrium and into the left ventricle through the deployed device110.

FIGS.9A and9Bare side cross-sectional views of a distal portion of a delivery system200for a prosthetic heart valve device110in a retained state (FIG.9A) and in a fully deployed state (FIG.9B) in accordance with another embodiment of the present technology. The delivery system200can include various features at least generally similar to the features of the system100described above with reference toFIGS.6-8B. For example, the delivery system200can be hydraulically driven by moving fluid to and from two separate chambers144(only the second chamber144bshown inFIGS.9A and9B) to move the housing126between deployment and containment configurations. The delivery system200also includes the fluid delivery shaft148with flanges154that define the outer bounds of the chambers144.

The delivery system200ofFIGS.9A and9Bfurther includes an engagement device272that is configured to maintain engagement between the delivery capsule106and the prosthetic heart valve device110after the prosthetic heart valve device110has been at least partially expanded. The engagement device272includes a shaft274that extends through (e.g., coaxially within) or alongside at least a portion of the fluid delivery shaft148and is controllable by a clinician from a proximal portion of the delivery system200(e.g., via the control unit104ofFIG.6). The shaft274can be a central or engagement shaft that includes a distal region273having a pedestal276with one or more engagement or attachment elements278that releasably mate with corresponding attachment features280extending from the outflow region of the prosthetic heart valve device110.

The attachment elements278can be recesses or pockets that retain correspondingly shaped attachment features280(e.g., pins or projections) on an outflow region of the prosthetic heart valve device110. For example, the attachment elements278can be circular pockets that receive eyelet-shaped attachment features280extending from the outflow region of the prosthetic heart valve device110and/or the attachment elements278can be T-shaped recesses that receive corresponding T-shaped attachment features280extending from the outflow region of the prosthetic heart valve device110.

FIG.9Cis a top view of the pedestal276illustrating one arrangement of the attachment elements278. The illustrated pedestal276includes four T-shaped recesses281spaced 90° apart from each other around the periphery of the pedestal276and circular pockets283spaced between the T-shaped recesses281. The T-shaped recesses281may extend deeper into the pedestal276than the circular pockets283(e.g., as shown inFIGS.9A and9B), or the attachment elements278can have similar depths. In other embodiments, the pedestal276has different quantities and/or arrangements of T-shaped recesses281and/or the circular pockets283across the face of the pedestal276. In further embodiments, the pedestal276can include differently shaped recesses and pockets that releasably mate with correspondingly-shaped attachment features on the prosthetic heart valve device110. In still further embodiments, the engagement device272includes other features that releasably attach the prosthetic heart valve device110to the delivery system200before final release from the delivery system200.

In the embodiment illustrated inFIGS.9A and9B, the second flange154bincludes a projection282that forms a recess284facing the prosthetic heart valve device110, and the recess284at least partially receives the pedestal276to retain the attachment features280with the attachment elements278. The projection282may extend toward the prosthetic heart valve device110beyond the surface of the pedestal276positioned therein such that the projection282at least partially constrains an end region of the prosthetic heart valve device110before full deployment. In other embodiments, the second flange154bdoes not include the projection282, and the pedestal276abuts an end surface of the second flange154band/or other outward-facing feature of the delivery capsule106.

In operation, a clinician moves the delivery capsule106to the target site (e.g., in a native mitral valve) and hydraulically moves the housing126to unsheathe and at least partially expand the prosthetic heart valve device110. When the prosthetic heart valve device110is substantially expanded (FIG.9A), the engagement device272holds the prosthetic heart valve device110to the delivery system200in case the device110needs to be resheathed for repositioning or redeployment. This allows the clinician to again partially or fully resheathe the prosthetic heart valve device110to adjust its position or orientation with respect to the native valve. Referring toFIG.9B, after the prosthetic heart valve device110is partially deployed at the appropriate location, the clinician can move the engagement shaft274in the direction of arrow285away from the remainder of the delivery capsule106and out of the recess284(e.g., in a distal direction when deployed trans-apically). This movement releases the mateably received attachment features280on the prosthetic heart valve device110from the corresponding attachment elements278to fully release the prosthetic heart valve device110from the delivery system200. For example, the expansion of the previously restrained proximal-most portion of the prosthetic heart valve device110(e.g., restrained by the projection282of the flange154b) results in a force that disengages the attachment features280from the attachment elements278and allows the device110to fully expand. In other embodiments, the engagement shaft274can remain stationary with respect to the prosthetic heart valve device110and the delivery capsule106(e.g., the housing126, the flange154b, etc.) can be moved away from the prosthetic heart valve device110(e.g., in a proximal direction when the device is deployed trans-apically) to disengage the attachment features280from the attachment elements278.

FIGS.10A-10Care a series of partially schematic illustrations of a distal portion of a hydraulic delivery system300deploying a prosthetic a prosthetic heart valve device310within a native mitral valve of a heart using a trans-septal approach in accordance with further embodiments of the present technology. The hydraulic delivery system300can include certain features generally similar the delivery systems100,200described above with reference toFIGS.6-9C. For example, the delivery system300includes a catheter302having an elongated catheter body308and a delivery capsule306at a distal portion308bof the catheter body308. The proximal portion of the catheter302can be coupled to a fluid system (e.g., the fluid assembly112ofFIG.6) and/or a manifold (e.g., the manifold158ofFIGS.8A and8B) to hydraulically move the delivery capsule306between a containment configuration and a deployment configuration. The delivery system300facilitates trans-septal delivery of the prosthetic heart valve device310to the native mitral valve MV.

Referring toFIG.10A, a puncture or opening341can be formed in an atrial region of a septum of the heart to access the left atrium LA. A guide catheter340can be positioned through the opening341, and a guidewire320can extend through the guide catheter340, through the mitral valve MV, and into the left ventricle LV. A delivery capsule306at a distal portion308bof the elongated catheter body308can then be delivered to the left atrium LA from the guide catheter340, advanced along the guidewire320, and positioned at a target site between the posterior and anterior leaflets PL and AL of the mitral valve MV.

As shown inFIG.10B, once at the target site in the mitral valve MV, the prosthetic heart valve device310can be deployed by removing a proximally positioned end cap328and moving a housing326of the delivery capsule306in 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 capsule306to hydraulically move the housing326toward the deployment configuration. This distal movement unsheathes the upstream or inflow portion of the prosthetic heart valve device310while the downstream or ventricular end of the prosthetic heart valve device310remains constrained within the housing326. 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 device310, fluid can be delivered to and removed from the delivery capsule chambers in an opposite manner to hydraulically move the housing326toward the containment configuration and at least partially resheathe the prosthetic heart valve device310. After the deployed inflow portion of the prosthetic heart valve device310is appropriately seated in the mitral valve MV, fluid can again be delivered to and removed from the delivery capsule chambers to again move the housing326distally toward the deployment configuration. As shown inFIG.10C, fluid can be delivered/removed until the housing326fully unsheathes the prosthetic heart valve device310and the prosthetic heart valve device310expands against the mitral valve MV. In the fully deployed state, the delivery capsule306can then be returned to the containment configuration (e.g., with the housing326and the end cap328joined together), pulled through the left atrium LA, and removed from the heart.

In other embodiments, the system100ofFIGS.6-8Bcan be reconfigured to allow for deployment from the left atrium (e.g., via the trans-septal approach shown inFIGS.10A-10C) in which case the housing126with the first and second chambers144aand144bhas the opposite orientation shown inFIGS.8A and8B. That is, the end cap128is positioned adjacent to the distal portion108bof the catheter body108and the housing126is located distally from the end cap128with the shaft148extending through or adjacent to the device110to allow fluid delivery to the chambers144. To deploy the prosthetic heart valve device110, fluid is removed from the first fluid chamber144awhile fluid is delivered to the second fluid chamber144b, which moves the housing126distally (further into the left ventricle) to at least partially unsheathe the prosthetic heart valve device110. To resheathe the prosthetic heart valve device110, fluid is removed from the second fluid chamber144bwhile fluid is delivered to the first fluid chamber144a, moving the housing126proximally (toward the catheter body108) toward the containment configuration.

FIGS.11A and11Bare enlarged, partially schematic cross-sectional views of a distal portion of the trans-septal delivery system300in a partially expanded deployment configuration (FIG.11A) and a resheathing or containment configuration (FIG.11B) in accordance with an embodiment of the present technology. As discussed above, the delivery system300includes the delivery capsule306coupled to the distal portion308bof the catheter body308. The delivery capsule306includes the housing326and a platform342that define, at least in part, a first or deployment chamber344a. The delivery system300further includes expandable member390coupled to the catheter body308and distal to the delivery capsule306. The interior of the expandable member390defines a second or resheathing chamber344b. The expandable member390can be a balloon or other expandable component in which a fluid can be contained and removed. The delivery system300can also include sealing features356(identified individually as a first sealing features356aand a second sealing feature356b), such as O-rings, to fluidically seal the deployment chamber344afrom a containment compartment346(FIG.11B) in the housing326that carries the prosthetic heart valve device310and the expandable member390. In other embodiments, the delivery system300can include additional sealing features for fluidically sealing the deployment chamber344aand the resheathing chamber344b.

As further shown inFIGS.11A and11B, a fluid delivery shaft348extends through the housing326and into the expandable member390. The fluid delivery shaft348includes at least a first fluid line352ain fluid communication with the deployment chamber344avia a first opening366aand a second fluid line352bin fluid communication with the resheathing chamber344bvia a second opening366b. The proximal portions of the fluid lines352can be in fluid communication with a manifold (not shown; e.g., the manifold158ofFIGS.8A and8B) and/or a fluid system (not shown; e.g., the fluid assembly112ofFIG.6) to allow fluid to be delivered to and removed from the deployment and resheathing chambers344aand344b. In other embodiments, the first fluid line352aand the second fluid line352bcan be separate components, such as two fluid delivery/removal shafts, one in fluid communication with the deployment chamber344aand one in fluid communication with the resheathing chamber344b. The fluid delivery shaft348can extend through the catheter body308, adjacent to the catheter body308. In other embodiments, the fluid delivery shaft348is omitted and the fluid lines352can be separate components that extend through the catheter body308.

In various embodiments, the delivery system300can further include a distal end cap392positioned distal to the expandable member390and coupled to the distal portion308bof the catheter body308and/or the fluid delivery shaft348. The distal end cap392can be configured to seal the distal end of the expandable member390and/or may have an atraumatic shape (e.g., frusto-conical, partially spherical, etc.) to facilitate atraumatic delivery of the delivery capsule306to the target site. As shown inFIGS.11A and11B, the distal end cap392can also include an opening330that allows for guidewire delivery of the delivery capsule306to the target site.

The delivery capsule306can be hydraulically driven between a containment configuration in which the prosthetic heart valve device310is held in the compartment346of the housing326and the deployment configuration in which at least a portion of the prosthetic heart valve device310expands from the compartment346. More specifically, in an initial containment state (e.g., as the delivery capsule306is delivered to the target site), the prosthetic heart valve device310is held in the compartment346of the housing326and the expandable member390is at least substantially empty (e.g., the configuration of the expandable member390shown inFIG.11A). To begin deployment, fluid is delivered to the deployment chamber344avia the first line352a(e.g., as indicated by arrows391inFIG.11A). Providing fluid to the deployment chamber344aincreases the pressure therein, thereby moving the housing326distally relative to the platform342and unsheathing the prosthetic heart valve device310(beginning with the atrial or inflow portion of the device310). This unsheathing mechanism at least substantially prevents translation of the prosthetic heart valve device310relative to the catheter body308and the surrounding anatomy to facilitate positioning and deployment of the device310.

As shown inFIG.11B, the prosthetic heart valve device310can be at least partially resheathed after at least partial deployment. To resheathe the device310, fluid is drained or removed from deployment chamber344a(as indicated by arrows393), while fluid is delivered to the expandable member390via the second line352b(as indicated by arrows395). The expansion of the expandable member390urges the housing326towards the containment configuration such that the prosthetic heart valve device310is at least partially resheathed and again positioned at least partially in the compartment346of the housing326(FIG.11B). Accordingly, the delivery system300provides for controlled, hydraulic delivery of the prosthetic heart valve device310via a trans-septal delivery approach and also inhibits translation of the prosthetic heart valve device310during deployment and resheathing to facilitate accurate delivery to the target site.

Selected Embodiments of Prosthetic Heart Valve Devices

The hydraulic delivery systems100,200,300described above with reference toFIGS.6-11Bcan 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 toFIGS.12A-25. Specific elements, substructures, advantages, uses, and/or other features of the embodiments described with reference toFIGS.12A-25can be suitably interchanged, substituted or otherwise configured with one another. Furthermore, suitable elements of the embodiments described with reference toFIGS.12A-25can be used as stand-alone and/or self-contained devices.

FIG.12Ais a side cross-sectional view andFIG.12Bis a top plan view of a prosthetic heart valve device (“device”)1100in accordance with an embodiment of the present technology. The device1100includes a valve support1110, an anchoring member1120attached to the valve support1110, and a prosthetic valve assembly1150within the valve support1110. Referring toFIG.12A, the valve support1110has an inflow region1112and an outflow region1114. The prosthetic valve assembly1150is arranged within the valve support1110to allow blood to flow from the inflow region1112through the outflow region1114(arrows BF), but prevent blood from flowing in a direction from the outflow region1114through the inflow region1112.

In the embodiment shown inFIG.12A, the anchoring member1120includes a base1122attached to the outflow region1114of the valve support1110and a plurality of arms1124projecting laterally outward from the base1122. The anchoring member1120also includes a fixation structure1130extending from the arms1124. The fixation structure1130can include a first portion1132and a second portion1134. The first portion1132of the fixation structure1130, for example, can be an upstream region of the fixation structure1130that, in a deployed configuration as shown inFIG.12A, is spaced laterally outward apart from the inflow region1112of the valve support1110by a gap G. The second portion1134of the fixation structure1130can be a downstream-most portion of the fixation structure1130. The fixation structure1130can be a cylindrical ring (e.g., straight cylinder or conical), and the outer surface of the fixation structure1130can define an annular engagement surface configured to press outwardly against a native annulus of a heart valve (e.g., a mitral valve). The fixation structure1130can further include a plurality of fixation elements1136that project radially outward and are inclined toward an upstream direction. The fixation elements1136, 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 device1100).

Referring still toFIG.12A, the anchoring member1120has a smooth bend1140between the arms1124and the fixation structure1130. For example, the second portion1134of the fixation structure1130extends from the arms1124at the smooth bend1140. The arms1124and the fixation structure1130can be formed integrally from a continuous strut or support element such that the smooth bend1140is a bent portion of the continuous strut. In other embodiments, the smooth bend1140can be a separate component with respect to either the arms1124or the fixation structure1130. For example, the smooth bend1140can be attached to the arms1124and/or the fixation structure1130using a weld, adhesive or other technique that forms a smooth connection. The smooth bend1140is configured such that the device1100can be recaptured in a capsule or other container after the device1100has been at least partially deployed.

The device1100can further include a first sealing member1162on the valve support1110and a second sealing member1164on the anchoring member1120. The first and second sealing members1162,1164can be made from a flexible material, such as Dacron® or another type of polymeric material. The first sealing member1162can cover the interior and/or exterior surfaces of the valve support1110. In the embodiment illustrated inFIG.12A, the first sealing member1162is attached to the interior surface of the valve support1110, and the prosthetic valve assembly1150is attached to the first sealing member1162and commissure portions of the valve support1110. The second sealing member1164is attached to the inner surface of the anchoring member1120. As a result, the outer annular engagement surface of the fixation structure1130is not covered by the second sealing member1164so that the outer annular engagement surface of the fixation structure1130directly contacts the tissue of the native annulus.

The device1100can further include an extension member1170. The extension member1170can be an extension of the second sealing member1164, or it can be a separate component attached to the second sealing member1164and/or the first portion1132of the fixation structure1130. The extension member1170can be a flexible member that, in a deployed state (FIG.12A), flexes relative to the first portion1132of the fixation structure1130. In operation, the extension member1170provides tactile feedback or a visual indicator (e.g., on echocardiographic or fluoroscopic imaging systems) to guide the device1100during implantation such that the device1100is located at a desired elevation and centered relative to the native annulus. As described below, the extension member1170can 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.

FIGS.13A and13Bare cross-sectional views illustrating an example of the operation of the smooth bend1140between the arms1124and the fixation structure1130in the recapturing of the device1100after partial deployment.FIG.13Aschematically shows the device1100loaded into a capsule1700of a delivery system in a delivery state, andFIG.13Bschematically shows the device1100in a partially deployed state. Referring toFIG.13A, the capsule1700has a housing1702, a pedestal or support1704, and a top1706. In the delivery state shown inFIG.13A, the device1100is in a low-profile configuration suitable for delivery through a catheter or cannula to a target implant site at a native heart valve.

Referring toFIG.13B, the housing1702of the capsule1700has been moved distally such that the extension member1170, fixation structure1130and a portion of the arms1124have been released from the housing1702in a partially deployed state. This is useful for locating the fixation structure1130at the proper elevation relative to the native valve annulus A such that the fixation structure1130expands radially outward into contact the inner surface of the native annulus A. However, the device1100may need to be repositioned and/or removed from the patient after being partially deployed. To do this, the housing1702is retracted (arrow R) back toward the fixation structure1130. As the housing1702slides along the arms1124, the smooth bend1140between the arms1124and the fixation structure1130allows the edge1708of the housing1702to slide over the smooth bend1140and thereby recapture the fixation structure1130and the extension member1170within the housing1702. The device1100can 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 toFIGS.14-25.

FIG.14is a top isometric view of an example of the device1100. In this embodiment, the valve support1110defines a first frame (e.g., an inner frame) and fixation structure1130of the anchoring member1120defines a second frame (e.g., an outer frame) that each include a plurality of structural elements. The fixation structure1130, more specifically, includes structural elements1137arranged in diamond-shaped cells1138that together form at least a substantially cylindrical ring when freely and fully expanded as shown inFIG.14. The structural elements1137can 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 structure1130can be a generally cylindrical fixation ring having an outwardly facing engagement surface. For example, in the embodiment shown inFIG.14, the outer surfaces of the structural elements1137define 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 structure1130are at least substantially parallel to those of the valve support1110. However, the fixation structure1130can 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 device1100shown inFIG.14includes the first sealing member1162lining the interior surface of the valve support1110, and the second sealing member1164along the inner surface of the fixation structure1130. The extension member1170has a flexible web1172(e.g., a fabric) and a support member1174(e.g., metal or polymeric strands) attached to the flexible web1172. The flexible web1172can extend from the second sealing member1164without a metal-to-metal connection between the fixation structure1130and the support member1174. For example, the extension member1170can be a continuation of the material of the second sealing member1164. Several embodiments of the extension member1170are thus a malleable or floppy structure that can readily flex with respect to the fixation structure1130. The support member1174can have a variety of configurations and be made from a variety of materials, such as a double-serpentine structure made from Nitinol.

FIG.15is a side view andFIG.16is a bottom isometric view of the device1100shown inFIG.14. Referring toFIG.15, the arms1124extend radially outward from the base portion1122at an angle α selected to position the fixation structure1130radially outward from the valve support1110(FIG.14) by a desired distance in a deployed state. The angle α is also selected to allow the edge1708of the delivery system housing1702(FIG.13B) to slide from the base portion1122toward the fixation structure1130during recapture. In many embodiments, the angle α is 15°-75°, or more specifically 15°-60°, or still more specifically 30°-45°. The arms1124and the structural elements1137of the fixation structure1130can be formed from the same struts (i.e., formed integrally with each other) such that the smooth bend1140is a continuous, smooth transition from the arms1124to the structural elements1137. This is expected to enable the edge1708of the housing1702to more readily slide over the smooth bend1140in a manner that allows the fixation structure1130to be recaptured in the housing1702of the capsule1700(FIG.13B). Additionally, by integrally forming the arms1124and the structural elements1137with each other, it inhibits damage to the device1100at a junction between the arms1124and the structural elements1137compared to a configuration in which the arms1124and structural elements1137are separate components and welded or otherwise fastened to each other.

Referring toFIGS.15and16, the arms1124are also separated from each other along their entire length from where they are connected to the base portion1122through the smooth bend1140(FIG.15) to the structural elements1137of the fixation structure1130. The individual arms1124are thus able to readily flex as the edge1708of the housing1702(FIG.13B) slides along the arms1124during recapture. This is expected to reduce the likelihood that the edge1708of the housing1702will catch on the arms1124and prevent the device1100from being recaptured in the housing1702.

In one embodiment, the arms1124have a first length from the base1122to the smooth bend1140, and the structural elements1137of the fixation structure1130at each side of a cell1138(FIG.14) have a second length that is less than the first length of the arms1124. The fixation structure1130is accordingly less flexible than the arms1124. As a result, the fixation structure1130is able to press outwardly against the native annulus with sufficient force to secure the device1100to the native annulus, while the arms1124are sufficiently flexible to fold inwardly when the device is recaptured in a delivery device.

In the embodiment illustrated inFIGS.14-16, the arms1124and the structural elements1137are configured such that each arm1124and the two structural elements1137extending from each arm1124formed a Y-shaped portion1142(FIG.16) of the anchoring member1120. Additionally, the right-hand structural element1137of each Y-shaped portion1142is coupled directly to a left-hand structural element1137of an immediately adjacent Y-shaped portion1142. The Y-shaped portions1142and the smooth bends1140are expected to further enhance the ability to slide the housing1702along the arms1124and the fixation structure1130during recapture.

FIG.17is a side view andFIG.18is a bottom isometric view of a prosthetic heart valve device (“device”)1200in accordance with another embodiment of the present technology. The device1200is shown without the extension member1170(FIGS.14-16), but the device1200can further include the extension member1170described above. The device1200further includes extended connectors1210projecting from the base1122of the anchoring member1120. Alternatively, the extended connectors1210can extend from the valve support1110(FIGS.12A-16) in addition to or in lieu of extending from the base1122of the anchoring member1120. The extended connectors1210can include a first strut1212aattached to one portion of the base1122and a second strut1212battached to another portion of the base1122. The first and second struts1212a-bare 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 struts1212a-bcauses the extension connector1210to elongate when the device1200is in a low-profile configuration within the capsule1700(FIG.13A) during delivery or partial deployment. When the device1200is fully released from the capsule1700(FIG.13A) the extension connectors1210foreshorten to avoid interfering with blood flow along the left ventricular outflow tract.

The extended connectors1210further include an attachment element1214configured to releasably engage a delivery device. The attachment element1214can be a T-bar or other element that prevents the device1200from being released from the capsule1700(FIG.13A) of a delivery device until desired. For example, a T-bar type attachment element1214can prevent the device1200from moving axially during deployment or partial deployment until the housing1702(FIG.13A) moves beyond the portion of the delivery device engaged with the attachment elements1214. This causes the attachment elements1214to disengage from the capsule1700(FIG.13A) as the outflow region of the valve support1110and the base1122of the anchoring member1120fully expand to allow for full deployment of the device1200.

FIG.19is a side view andFIG.20is a bottom isometric view of the device1200in a partially deployed state in which the device1200is still capable of being recaptured in the housing1702of the delivery device1700. Referring toFIG.19, the device1200is partially deployed with the fixation structure1130substantially expanded but the attachment elements1214(FIG.17) still retained within the capsule1700. This is useful for determining the accuracy of the position of the device1200and allowing blood to flow through the functioning replacement valve during implantation while retaining the ability to recapture the device1200in case it needs to be repositioned or removed from the patient. In this state of partial deployment, the elongated first and second struts1212a-bof the extended connectors1210space the base1122of the anchoring member1120and the outflow region of the valve support1110(FIG.12A) apart from the edge1708of the capsule1700by a gap G.

Referring toFIG.20, the gap G enables blood to flow through the prosthetic valve assembly1150while the device1200is only partially deployed. As a result, the device1200can be partially deployed to determine (a) whether the device1200is positioned correctly with respect to the native heart valve anatomy and (b) whether proper blood flow passes through the prosthetic valve assembly1150while the device1200is still retained by the delivery system1700. As such, the device1200can 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 device1200and assess, in vivo, whether the device1200will operate as intended, while retaining the ability to reposition the device1200for redeployment or remove the device1200from the patient.

FIG.21is an isometric view of a valve support1300in accordance with an embodiment of the present technology. The valve support1300can be an embodiment of the valve support1110described above with respect toFIGS.12A-20. The valve support1300has an outflow region1302, an inflow region1304, a first row1310of first hexagonal cells1312at the outflow region1302, and a second row1320of second hexagonal cells1322at the inflow region1304. For purposes of illustration, the valve support shown inFIG.21is inverted compared to the valve support1110shown inFIGS.12A-20such that the blood flows through the valve support1300in the direction of arrow BF. In mitral valve applications, the valve support1300would be positioned within the anchoring member1120(FIG.12A) such that the inflow region1304would correspond to orientation of the inflow region1112inFIG.12Aand the outflow region1302would correspond to the orientation of the outflow region1114inFIG.12A.

Each of the first hexagonal cells1312includes a pair of first longitudinal supports1314, a downstream apex1315, and an upstream apex1316. Each of the second hexagonal cells1322can include a pair of second longitudinal supports1324, a downstream apex1325, and an upstream apex1326. The first and second rows1310and1312of the first and second hexagonal cells1312and1322are directly adjacent to each other. In the illustrated embodiment, the first longitudinal supports1314extend directly from the downstream apexes1325of the second hexagonal cells1322, and the second longitudinal supports1324extend directly from the upstream apexes1316of the first hexagonal cells1312. As a result, the first hexagonal cells1312are offset from the second hexagonal cells1322around the circumference of the valve support1300by half of the cell width.

In the embodiment illustrated inFIG.21, the valve support1300includes a plurality of first struts1331at the outflow region1302, a plurality of second struts1332at the inflow region1304, and a plurality of third struts1333between the first and second struts1331and1332. Each of the first struts1331extends from a downstream end of the first longitudinal supports1314, and pairs of the first struts1331are connected together to form first downstream V-struts defining the downstream apexes1315of the first hexagonal cells1312. In a related sense, each of the second struts1332extends from an upstream end of the second longitudinal supports1324, and pairs of the second struts1332are connected together to form second upstream V-struts defining the upstream apexes1326of the second hexagonal cells1322. Each of the third struts1333has a downstream end connected to an upstream end of the first longitudinal supports1314, and each of the third struts1333has an upstream end connected to a downstream end of one of the second longitudinal supports1324. The downstream ends of the third struts1333accordingly define a second downstream V-strut arrangement that forms the downstream apexes1325of the second hexagonal cells1322, and the upstream ends of the third struts1333define a first upstream V-strut arrangement that forms the upstream apexes1316of the first hexagonal cells1312. The third struts1333, therefore, define both the first upstream V-struts of the first hexagonal cells1312and the second downstream V-struts of the second hexagonal cells1322.

The first longitudinal supports1314can include a plurality of holes1336through which sutures can pass to attach a prosthetic valve assembly and/or a sealing member. In the embodiment illustrated inFIG.21, only the first longitudinal supports1314have holes1336. However, in other embodiments the second longitudinal supports1324can also include holes either in addition to or in lieu of the holes1336in the first longitudinal supports1314.

FIG.22is a side view andFIG.23is a bottom isometric view of the valve support1300with a first sealing member1162attached to the valve support1300and a prosthetic valve1150within the valve support1300. The first sealing member1162can be attached to the valve support1300by a plurality of sutures1360coupled to the first longitudinal supports1314and the second longitudinal supports1324. At least some of the sutures1360coupled to the first longitudinal supports1314pass through the holes1336to further secure the first sealing member1162to the valve support1300.

Referring toFIG.23, the prosthetic valve1150can be attached to the first sealing member1162and/or the first longitudinal supports1314of the valve support1300. For example, the commissure portions of the prosthetic valve1150can be aligned with the first longitudinal supports1314, and the sutures1360can pass through both the commissure portions of the prosthetic valve1150and the first sealing member1162where the commissure portions of the prosthetic valve1150are aligned with a first longitudinal support1314. The inflow portion of the prosthetic valve1150can be sewn to the first sealing member1162.

The valve support1300illustrated inFIGS.21-23is expected to be well suited for use with the device1200described above with reference toFIGS.17-20. More specifically, the first struts1331cooperate with the extended connectors1210(FIGS.17-20) of the device1200to separate the outflow portion of the prosthetic valve1150from the capsule1700(FIGS.19-20) when the device1200is in a partially deployed state. The first struts1331, for example, elongate when the valve support1300is not fully expanded (e.g., at least partially contained within the capsule1700) and foreshorten when the valve support is fully expanded. This allows the outflow portion of the prosthetic valve1150to be spaced further apart from the capsule1700in a partially deployed state so that the prosthetic valve1150can at least partially function when the device1200(FIGS.17-20) is in the partially deployed state. Therefore, the valve support1300is expected to enhance the ability to assess whether the prosthetic valve1150is fully operational in a partially deployed state.

FIGS.24and25are schematic side views of valve supports1400and1500, respectively, in accordance with other embodiments of the present technology. Referring toFIG.24, the valve support1400includes a first row1410of first of hexagonal cells1412and a second row1420of second hexagonal cells1422. The valve1400can further include a first row1430of diamond-shaped cells extending from the first hexagonal cells1412and a second row1440of diamond-shaped cells extending from the second hexagonal cells1422. The additional diamond-shaped cells elongate in the low-profile state, and thus they can further space the prosthetic valve1150(shown schematically) apart from a capsule of a delivery device. Referring toFIG.25, the valve support1500includes a first row1510of first hexagonal cells1512at an outflow region1502and a second row1520of second hexagonal cells1522at an inflow region1504. The valve support1500is shaped such that an intermediate region1506(between the inflow and outflow regions1502and1504) has a smaller cross-sectional area than that of the outflow region1502and/or the inflow region1504. As such, the first row1510of first hexagonal cells1512flares outwardly in the downstream direction and the second row1520of second hexagonal cells1522flares outwardly in the upstream direction.

Examples

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

1. A system for delivering a prosthetic heart valve device into a heart of a patient, the system comprising:an elongated catheter body; anda delivery capsule 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 and a platform, and wherein—the housing and the platform define, at least in part, a first chamber and a second chamber,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, andat 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.

2. The system of example 1, further comprising a manifold at a proximal end region of the elongated catheter body and configured to receive the fluid for delivery to the first and/or second chambers, wherein the manifold comprises a first fluid lumen and first valve in fluid communication with the first chamber, and a second fluid lumen and a second valve in fluid communication with the second chamber.

3. The system of example 2 wherein the first and second valves are three-way valves.

4. The system of example 2 wherein the manifold is configured to be external to the patient during a implantation procedure.

5. The system of example 2 wherein the first fluid lumen is fluidly isolated from the second fluid lumen.

6. The system of any one of examples 1-5 wherein the delivery capsule is configured to axially restrain the prosthetic heart valve device while a first portion of the prosthetic heart valve device is deployed from the delivery capsule and to release an axially restrained portion of the prosthetic heart valve device while the first portion of the prosthetic heart valve device contacts tissue of a native valve of the heart of the patient.

7. The system of any one of examples 1-6 wherein the delivery capsule is configured to substantially prevent translation of the prosthetic heart valve device relative to the elongated catheter body while the prosthetic heart valve device moves between the containment configuration and the deployment configuration.

8. The system of any one of examples 1-7, further comprising a biasing device positioned along the catheter body and configured to urge the delivery capsule towards the containment configuration.

9. The system of example 8 wherein the biasing device comprises a spring positioned to be compressed as the delivery capsule moves towards the deployment configuration to deploy the prosthetic heart valve device when fluid is transferred to the first chamber.

10. The system of any one of examples 1-9, further comprising an engagement shaft extending through at least a portion of the elongated catheter body, wherein a distal end region of the engagement shaft is releasably coupled to the prosthetic heart valve device via one or more attachment elements, and wherein the one or attachment elements comprise pockets configured to mate with corresponding attachment features of the prosthetic heart valve device.

11. The system of example 10 wherein the attachment features comprise eyelet shaped projections configured to releasably engage corresponding pockets at the distal end region of the engagement shaft.

12. The system of example 10 wherein the attachment features comprise T-shaped projections configured to releasably mate with corresponding T-shaped pockets at the distal end region of the engagement shaft.

13. A system for delivering a prosthetic heart valve device for implantation at a native heart valve of a patient, the system comprising:an elongated catheter body;a delivery capsule coupled to the elongated catheter body and configured to contain the prosthetic heart valve device, wherein—the delivery capsule is configured to be hydraulically driven between a containment configuration for holding the prosthetic heart valve device and a deployment configuration for deploying at least a portion of the prosthetic heart valve device,the delivery capsule includes a housing and a platform that define, at least in part, a deployment chamber; andan expandable member coupled to the elongated catheter body and distal to the delivery capsule, wherein the expandable member is configured to urge the delivery capsule towards the containment configuration and resheathe at least a portion of the prosthetic heart valve device when fluid is at least partially drained from the deployment chamber while fluid is delivered to the expandable member.

14. The system of example 13 wherein the delivery capsule is configured to substantially prevent translation of the prosthetic heart valve device relative to the elongated catheter body while the prosthetic heart valve device is at least partially resheathed.

15. The system of example 13 or 14 wherein the delivery capsule further comprises a containment chamber configured to contain the prosthetic heart valve device, and wherein the containment chamber is fluidically sealed from the deployment chamber via the platform1.

16. The system of any one of examples 13-15 wherein the expandable member is a balloon.

17. A method for delivering a prosthetic heart valve device to a native mitral valve of a heart of a human patient, the method comprising:positioning a delivery capsule of an elongated catheter body within the heart, the delivery capsule carrying the prosthetic heart valve device;delivering fluid to a first chamber within the delivery capsule to move the prosthetic heart valve device from a containment configuration within the delivery capsule to a deployment configuration, wherein the first chamber is proximal to the prosthetic heart valve device;while fluid is delivered to the first chamber, draining fluid from a second chamber within the delivery capsule, wherein the second chamber is proximal to the prosthetic heart valve device; andallowing the prosthetic heart valve device to radially expand to engage tissue of the native mitral valve when the delivery capsule moves from the containment configuration towards the deployment configuration.

18. The method of example 17, further comprising:urging the delivery capsule toward the containment configuration to resheathe the prosthetic heart valve device after allowing the prosthetic heart valve device to at least partially radially expand, wherein urging the delivery capsule toward the containment configuration comprises—draining fluid from the first chamber; andwhile draining fluid from the first chamber, delivering fluid to the second chamber.

19. The method of example 17 or 18 wherein:delivering fluid to the first chamber comprises delivering fluid from a manifold at a proximal portion of the elongated catheter body via a first fluid lumen; anddraining fluid from the second chamber comprises removing fluid via a second fluid lumen to the manifold.

20. The method of any one of examples 17-19 wherein delivering fluid to the first chamber and draining fluid from the second chamber at least substantially prevents translation of the prosethetic heart valve device relative to the elongated catheter body while the prosthetic heart valve device moves from the containment configuration to the deployment configuration.

21. The method of any one of examples 17-20, further comprising restraining a distal portion of the prosthetic heart valve device as the prosthetic heart valve device moves between the containment and deployment configurations, wherein the distal portion of the prosthetic heart valve device comprises attachment elements that releasably couple to pockets at a distal end region of an engagement shaft that extends through the elongated catheter body.

22. The method of example 21, further comprising moving the engagement shaft distally relative to the delivery capsule to release the restrained distal portion of the distal end region of the engagement shaft and fully expand the prosthetic heart valve device.

CONCLUSION

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.

Moreover, unless the word “or” is expressly limited to mean only a single item exclusive from the other items in reference to a list of two or more items, then the use of “or” in such a list is to be interpreted as including (a) any single item in the list, (b) all of the items in the list, or (c) any combination of the items in the list. Additionally, the term “comprising” is used throughout to mean including at least the recited feature(s) such that any greater number of the same feature and/or additional types of other features are not precluded. It will also be appreciated 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 disclosure and associated technology can encompass other embodiments not expressly shown or described herein.