Patent Description:
The present technology relates generally to devices and systems for delivering medical devices into a patient. In particular, several embodiments of the present technology are related to hydraulic delivery systems with flow diversion devices for deploying prosthetic heart valve devices.

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 into 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 (e.g., 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 recently. Examples of pre-assembled, percutaneous prosthetic valves include, e.g., the CoreValve Revalving® System from Medtronic/Corevalve Inc. (Irvine, CA, USA) and the Edwards-Sapient 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 devices may not be well suited for other types of heart valves.

Therefore, during a mitral valve replacement procedure, it is critical yet challenging to deploy an implant in a timely manner and targeted position due to the complex anatomy of a heart. Accordingly, it is desirable for delivery systems to enable complex operations in a flexible manner to facilitate targeted delivery of an implant with minimal time and procedural steps by alleviating the physical and cognitive burdens on clinicians operating the delivery systems during replacement procedures. <CIT> relates to hydraulic systems for delivering prosthetic heart valve devices.

The invention relates to a flow diversion device for controlling fluid flow in a delivery system to deploy a prosthetic heart valve device. The flow diversion device comprises a housing including a plurality of channels that intersect at a junction, and a plurality of openings of the plurality of channels in fluid communication with the junction, wherein the plurality of openings includes a first opening and a second opening. The flow diversion device further comprises a flow control component disposed at the junction and movable to selectively form a plurality of pathways including a first pathway and a second pathway for fluid communication via the plurality of channels between the plurality of openings based on a position of the flow control component, wherein when the flow control component is in a first position, the first pathway is formed to allow fluid flow through at least the first opening toward a first chamber of the delivery system to cause deployment of the prosthetic heart valve device, and wherein when the flow control component is in a second position, the second pathway is formed to allow fluid flow through at least the second opening toward a second chamber of the delivery system to cause recapture of the prosthetic heart valve device. The flow diversion device further comprises a handle operably coupled to the flow control component and movable to position the flow control component in at least either the first position and the second position to selectively allow fluid flow toward at least either the first chamber or the second chamber of the delivery system.

In some examples, the disclosure relates to a system for delivering a prosthetic heart valve device into a heart of a patient. The system comprises an elongated catheter body including a delivery control component that is hydraulically driven to deploy and recapture the prosthetic heart valve device relative to the heart of the patient, and a flow diversion device including a housing including a plurality of openings of a plurality of channels that intersect at a junction, a flow control component disposed at the junction and movable to selectively form a plurality of pathways for fluid communication between the plurality of openings via the plurality of channels based on a position of the flow control component, wherein when the flow control component is in a first position, a first pathway is formed to allow fluid flow through a first opening of the plurality of openings to deploy the prosthetic heart valve device into the heart of the patient by filling a first chamber of the system, and wherein when the flow control component is in a second position, a second pathway is formed to allow fluid flow through a second opening of the plurality of openings to recapture the prosthetic heart valve device from the heart of the patient by draining the first chamber of the system. The system further comprises a handle movable to change a position of the flow control component between the first position and the second position to select from among the plurality of pathways for fluid communication with the first chamber.

In some examples, the disclosure relates to a flow diversion device that controls fluid flow in a system configured to implant a medical device in a patient. The flow diversion device comprises a housing including a plurality of openings of a plurality of channels that intersect at a junction; a flow control component disposed at the junction and movable to form one or more pathways for fluid communication between the plurality of openings based on a position of the flow control component, wherein when the flow control component is in a first position, a first pathway is formed to allow fluid flow through a first opening of the plurality of openings toward a first chamber of the delivery control component to cause deployment of the medical device; and wherein when the flow control component is in a second position, a second pathway is formed to allow fluid flow through a second opening of the plurality of openings toward a second chamber to cause recapture of the medical device; and a handle operably coupled to the flow control component and movable to change the position of the flow control component between at least the first position and the second position to selectively form any of the plurality of pathways for fluid communication with at least the first and second chambers of the delivery control component.

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 delivery systems with flow diversion devices for delivering medical 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. 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 with flow diversion devices for 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 nonplanar, 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 allow 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 prosthesis, 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.

During transcatheter mitral valve replacement (e.g., delivered via a transfemoral or transapical approach), it is critical to deploy the valve replacement device in a timely manner and in a correct position relative to the native annulus, leaflets, left atrium, and left ventricular outflow tract. Accordingly, it is desirable for a delivery system to enable flexible deployment and/or recapture of a valve replacement device with minimal time and procedural steps. However, conventional delivery systems include burdensome flow diversion devices such as an arrangement of multiple interconnected three-way stopcocks that must be separately adjusted to desired positions to change the direction of a delivery from deploy to recapture, or vice versa. This arrangement can be confusing and require excessive additional time such that use of conventional flow diversion devices poses a physical and cognitive burden on a clinician, and increases the risks associated with replacement procedures.

Embodiments of the present technology provide systems, methods and apparatuses 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 valve replacement device. The disclosed embodiments include a flow diversion device that can perform complex operations to flexibly place a valve replacement device in a target position, in a timely manner, by reducing the physical and cognitive burdens on a clinician to operate the flow diversion device.

The disclosed embodiments overcome the aforementioned drawbacks with flow diversion devices of dual-hydraulic delivery systems that can readily and reliably deploy and/or recapture valve replacement devices. For example, a flow diversion device of the disclosed embodiments can implement a toggle mechanism that only requires a single action to switch between deploy and recapture configurations. The disclosed embodiments thus obviate the need for an arrangement of multiple interconnected three-way stopcocks, which saves the clinician time by simplifying operations for changing the delivery device from deploy to recapture configurations, or vice versa.

The disclosed systems 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 systems and methods are particularly well-suited for trans-septal and transapical 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 systems 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 disclosed flow diversion devices facilitate controlled delivery of a prosthetic heart valve device using transapical 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 disclosed flow diversion devices are coupled to two 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 delivery 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). The disclosed hydraulic delivery systems transfer forces more efficiently compared to mechanical delivery systems that experience frictional losses due to mechanical linkages between distal and proximal ends. In addition, the disclosed hydraulic delivery systems 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 (i.e., fully recaptured) and the deployment configuration. This allows the clinician to accurately 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 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 transapical 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> 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 transapical approach via a transapical 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 disclosure may then be introduced into the left ventricle through this access cannula. The transapical approach provides a shorter, straighter, and more direct path to the mitral or aortic valve. Further, because it does not involve intravascular access, the transapical approach does not require training in interventional cardiology to perform the catheterizations required in other percutaneous approaches.

During transcatheter heart valve replacement (e.g., delivered via transfemoral or transapical approach), it is important to deploy the prosthetic heart valve device in a controlled and efficient manner to a target position relative to the native annulus, leaflets, left atrium, and the left ventricular outflow tract (LVOT). For example, delivery systems can hydraulically control movement of a delivery capsule to reduce, limit, or substantially eliminate uncontrolled deployment (also referred to as "jumping") of the prosthetic heart valve device caused by forces associated with the expanding heart valve device. Delivery systems can also use hydraulically controlled movement to resheathe a partially or fully-expanded heart valve device to allow for repositioning of the heart valve device relative to the native anatomy and/or recapture of the device for removal from the body.

The hydraulic delivery systems described herein include flow diversion devices that facilitate changing between deployment and recapture configurations to provide bi-directional movement of delivery components. For example, the disclosed flow diversion devices do not include multiple independent stopcocks that require separate manipulation to change direction of movement of a delivery capsule. Instead, the disclosed flow diversion devices have a single actuator that can be manipulated to direct fluid in at least two different directions and, as a result, provide for the reversal of delivery capsule direction. In some embodiments, a flow diversion device has a handle that can toggle between two positions to move the delivery capsule in opposite directions, and thereby cause either deployment or recapture of a prosthetic heart valve device. As a result, the disclosed flow diversion devices simplify the process for performing complex operations to switch between deployment and recapture configurations and enhance the efficiency and ease of use of the delivery procedure.

<FIG> is an isometric view of a hydraulic delivery system <NUM> ("system <NUM>") for delivering a prosthetic heart valve device configured in accordance with embodiments of the present technology. The system <NUM> includes a catheter <NUM> with an elongated catheter body <NUM> and a delivery capsule <NUM>. The catheter body <NUM> can include a proximal portion 108a coupled to a handheld 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 a 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) 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> also includes a flow diversion device <NUM> configured to supply a flowable substance (i.e., a hydraulic fluid, such as water or saline) to the catheter <NUM> and receive the fluid from the catheter <NUM>, to hydraulically move the delivery capsule <NUM> and deploy the prosthetic heart valve device <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 handle, 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 flow diversion device <NUM>. For example, the control assembly <NUM> can include buttons, levers, and/or other actuators that initiate unsheathing and/or resheathing of 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 from an end portion of the housing <NUM> and encloses the prosthetic heart valve device <NUM> within the housing <NUM>. The delivery capsule <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 distal portion of the delivery capsule <NUM> can also have an atraumatic shape (e.g., a partially spherical shape, a frusto-conical shape, blunt configuration, rounded configuration) to facilitate atraumatic delivery of the delivery capsule <NUM> to the target site. The housing <NUM>, the end cap <NUM>, and/or other portions of the delivery capsule <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 flow diversion device <NUM> between a containment configuration or state for holding the prosthetic heart valve device <NUM> within the delivery capsule <NUM> and a deployment configuration or state for at least partially deploying the prosthetic heart valve device <NUM> from the delivery capsule <NUM> at the target site. The control unit and/or the flow diversion device <NUM> also allows for resheathing (e.g., recapture) of the prosthetic heart valve device <NUM> after it has been partially deployed. For example, the delivery capsule <NUM> can be hydraulically driven from the containment configuration towards the deployment configuration by supplying a flowable liquid to a chamber of the delivery capsule <NUM> while, optionally, 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. After partial deployment from the delivery capsule <NUM>, the delivery capsule <NUM> can be hydraulically driven back towards the containment configuration (e.g., recapturing the device <NUM>) by transferring fluid into one chamber of the delivery capsule <NUM> and, optionally, removing fluid from another chamber of the delivery capsule <NUM> in an opposite manner as that used for deployment. The resheathing (also referred to as recapturing herein) ability allows the clinician to re-position 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 for removal from the patient. After removing the catheter <NUM>, it can be sanitized and used to deliver additional prosthetic devices, or it can be discarded.

As further shown in <FIG>, the flow diversion device <NUM> is fluidically coupled to the catheter <NUM> via one or more fluid line(s) <NUM>. The flow diversion device <NUM> is also fluidically coupled to one or more reservoirs <NUM> (identified individually as first and second reservoirs 114a and 114b, respectively) that can contain a flowable substance (e.g., water, saline) to hydraulically drive movement of the delivery capsule <NUM>. Each of the reservoirs <NUM> may include one or more fluid sources, such as an inflator device with pressurized fluid and/or a drain configured to receive drained fluid. The flow diversion device <NUM> and/or the fluid reservoirs <NUM> can also include one or more hoses, tubes, or other components (e.g., fittings, connectors, valves, pumps) through which a fluid can pass from the reservoir(s) <NUM> to the catheter <NUM>, and/or through which the fluid can drain from the catheter <NUM> to the reservoir(s) <NUM>. During use, the flow diversion device <NUM> can be manipulated to move fluid from one or more of the reservoirs <NUM> to the catheter <NUM> via the fluid line(s) <NUM> and/or drain fluid from the catheter <NUM> to one or more of the reservoirs <NUM> via the fluid line(s) <NUM>.

As further shown in the embodiment illustrated in <FIG>, the flow diversion device <NUM> includes an outer housing <NUM> that at least partially encloses a flow control mechanism for controlling the flow of fluid to and from the catheter <NUM> and the reservoirs <NUM>. The flow control mechanism can include mechanical elements, such as a cylindrical member received by an elongated aperture (e.g., a bore) in the housing <NUM> and movable longitudinally with respect to the aperture to switch the direction of fluid flow through channels formed in part by an arrangement of sealed compartments within the housing <NUM>. In some embodiments, the flow control mechanism includes levers, and/or other actuators to control deployment or resheathing of the prosthetic heart valve device <NUM>. For example, the flow control mechanism can include rotational elements, such as a handle <NUM> that can be rotated or otherwise manipulated to cause the cylinder to move longitudinally and thereby change the direction of fluid flow along the fluid lines <NUM>.

In some embodiments, the flow diversion device <NUM> and/or other portions of the system <NUM> are coupled to a controller (not shown) that 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 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 can further include a manual input device (e.g., a keyboard, a touch screen) and/or an automated input device (e.g., a computer, a data storage device, servers, network). In other embodiments, the controller may include different features and/or have a different arrangement for controlling the flow of fluid into and out of the reservoirs <NUM>. In still other embodiments, one or more components or at least a portion of the flow diversion device <NUM> are integrated into a handle of the system <NUM>.

<FIG> and <FIG> are partial cross-sectional views of the delivery system <NUM> of <FIG> in a containment configuration (<FIG>) and a deployment configuration (<FIG>) in accordance with embodiments of the present technology. As shown in <FIG> and <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 at least a portion of 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>. In some embodiments, one or both of the chambers <NUM> are contained in the catheter body <NUM>, the control unit <NUM> (<FIG>), a different handle, and/or another portion of the system <NUM>.

As shown in <FIG>, 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> 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 144a (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). 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> and <FIG>, a fluid delivery shaft <NUM> extends through the catheter body <NUM>, into the housing <NUM> of the delivery capsule <NUM>, and through the platform <NUM>. At a proximal end (not shown), the shaft <NUM> is coupled to the flow diversion device <NUM> 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 distal end of the housing <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 the flow diversion device <NUM> at a proximal portion of the system <NUM> (e.g., via the fluid lines <NUM> shown in <FIG>). The flow diversion device <NUM> includes the housing <NUM>, which encloses or defines an arrangement of interconnected channels <NUM> (examples of which are illustrated in further detail in <FIG> and <FIG>) that intersect at a junction structure <NUM> (e.g., a tubular structure or aperture). The junction structure <NUM> and the channels <NUM> are in fluid communication with apertures or openings <NUM> at or accessible via the exterior of the housing <NUM>. A plurality of fittings <NUM> (identified individually as first through fourth fittings 186a-d, respectively) are attached to the housing <NUM> and aligned with openings <NUM> (identified individually as first through fourth openings 185a-d, respectively)in the housing <NUM> to provide fluid access for fluid lines (e.g., via the fluid lines <NUM> shown in <FIG>) coupling the flow diversion device to the catheter <NUM> (<FIG>) and/or the reservoirs <NUM> (<FIG>). The flow diversion device <NUM> also includes a flow control component <NUM> (e.g., a shaft) disposed along or within the junction structure <NUM> and a handle <NUM> operably coupled to the flow control component <NUM>. The flow control component <NUM> is longitudinally and/or rotatably movable along the junction structure <NUM> to selectively form one or more fluid pathways <NUM> (identified individually in <FIG> and <FIG> as first through fourth pathways 182a-d, respectively) along a subset of the channels <NUM> to provide fluid communication between the fittings <NUM> and the components fluidically coupled thereto (e.g., fluid lines, reservoirs, delivery capsules). Manipulating the handle <NUM> moves the flow control component <NUM> to different positions along the junction structure <NUM> to regulate fluid flow to and from the chambers <NUM> of the delivery system <NUM>. For example, toggling the handle <NUM> between two different positions can move the flow control component <NUM> to a first position (e.g., containment or recapture configuration) and a second position (e.g., deployment configuration) to selectively allow fluid flow toward the first chamber 144a and remove fluid from the second chamber 144b, or vice versa.

As shown in <FIG>, when the flow control component <NUM> is placed in the first position (e.g., via the handle <NUM>), the fluid control component <NUM> defines the first and second fluid pathways 182a and 182b for removing and delivering fluid to different chambers <NUM> of the delivery system <NUM>. In the illustrated embodiment, for example, the second pathway 182b allows fluid flow from the fourth fitting 186d to the first fitting 186a toward the first chamber 144a, and the first fluid pathway 182a allows fluid to drain from the second chamber 144b. This simultaneous or concurrent fluid delivery and removal via the two pathways <NUM> collectively causes the delivery system <NUM> to move from the containment configuration to the deployment configuration and enables deployment of the prosthetic heart valve device <NUM>.

As shown in <FIG>, when the flow control component <NUM> is positioned in a second position, the fluid control component <NUM> defines the third and fourth fluid pathways 182c and 182d for removing and delivering fluid to different chambers <NUM>. In the illustrated embodiment, for example, the third pathway 182c allows fluid to drain from the second chamber 144b, while the fourth pathway 182d allows fluid flow toward the first chamber 144a. This concurrent movement of fluid to and from the chambers <NUM> to move the delivery system <NUM> from the deployed or partially deployed configuration to the containment configuration, thereby enabling recapture of the prosthetic heart valve device <NUM>.

Therefore, movement of the fluid control component <NUM> between the first and second positions causes the openings <NUM> and the associated fittings <NUM> to alternatively serve as outlets and inlets depending on whether the delivery system is moving toward a deployment configuration for unsheathing the prosthetic heart valve device <NUM> or toward the containment configuration for resheathing the prosthetic heart valve device <NUM> or overall delivery system <NUM> removal. In the illustrated embodiment, for example, the first opening 185a and associated first fitting 186a serves as an outlet when the flow control component <NUM> is in the first position for device deployment and serves as an inlet when the flow control component <NUM> is in the second position for device recapture or system removal. Meanwhile, the second opening 185b and the second fitting 186b serves as an inlet when the flow control component <NUM> is in the first position and serves as an outlet when the flow control component <NUM> is in the second position. The third opening 185c and the associated third fitting 186c can serve as outlet regardless of whether the flow control component <NUM> is in the first or second position to provide a consistent fluid drainage site, and the fourth opening 185d and associated fitting 186d can serve as an inlet to supply fluid to one or both chamber <NUM> regardless of the position of the flow control component <NUM>. This enables the third and fourth fittings 186c and 186d to maintain connections to a fluid retention or drainage reservoir and a fluid supply reservoir, respectively, throughout the delivery process. In other embodiments, the flow diversion device <NUM> can be configured such that direction of fluid through the third and fourth fittings 186c and 186d can be reversed based on positional changes of the fluid control component <NUM>.

During use, the system <NUM> is arranged in the containment configuration (<FIG>) when the delivery capsule <NUM> is delivered to the target site at a native heart valve (e.g., via a transapical or trans-septal delivery approach). To fully or partially unsheathe the prosthetic heart valve device <NUM>, the handle <NUM> is manipulated to move the fluid control component <NUM> to the first position. This allows fluid to flow along the first fluid pathway 182b, through the first fitting 186a (as indicated by arrow <NUM>), to the second fluid line 152b, and into the second chamber 144b. As fluid is delivered to the second chamber 144b, fluid also drains through the first fluid line 152a from the first chamber 144a, toward the second fitting 186b (as indicated by arrow <NUM>), and through the second fluid pathway 182b. In some 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 some embodiments, different amounts of fluid are drained from and transferred to the chambers <NUM>. This concurrent transfer of fluid between the chambers <NUM> drives the housing <NUM> proximally in the direction of arrow <NUM> to deploy the prosthetic heart valve device <NUM>.

In the deployment configuration shown in <FIG>, 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 handle <NUM> is manipulated to move the flow control component <NUM> to the second position. This allows fluid to drain from the second chamber 144b, through the second fluid line 152b, into the fitting 186a (as indicated by arrows <NUM>), and along the third fluid pathway 182c. As fluid exits the second chamber 144b, fluid is also delivered to the first chamber 144a. That is, fluid moves through the fourth fluid pathway 182d, through the second fitting 186b, and to the first fluid line 152a (as indicated by arrows <NUM>). Again, the fluid can be transferred simultaneously and/or in equal proportions from the two chambers <NUM>. 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> can 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> and <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 positioned within the distal portion 108b of the catheter body <NUM>, but in other embodiments the biasing device <NUM> can be positioned in other portions of the system <NUM>, such as in the handle or control unit <NUM> (<FIG>). The biasing device can be a spring or other feature that urges the housing <NUM> and/or other portion of the delivery capsule <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>.

<FIG> and <FIG> illustrate top and bottom views, respectively, of a flow diversion device <NUM> configured to control fluid flow for deployment and recapture of an implantable device, such as a prosthetic heart valve device, in accordance with embodiments of the present technology. For example, the flow diversion device <NUM> can be used with the system <NUM> described above with respect to <FIG> to facilitate deployment of the prosthetic heart valve device <NUM> at a target site (e.g., a native mitral valve, a native tricuspid valve, a native aortic valve). The flow diversion device <NUM> can include various features generally similar to the features of the flow diversion device <NUM> described above with respect to <FIG>. For example, the flow diversion device <NUM> includes a housing <NUM> coupled to an actuator or handle <NUM>, and the handle <NUM> can be toggled between at least two positions to change the path and/or the direction of fluid flow through the flow diversion device <NUM>. In some embodiments, for example, changing the handle position enables the flow diversion device <NUM> to alternatingly deliver fluid to and/or remove fluid from a plurality of delivery system chambers (e.g., the chambers <NUM> of <FIG> and <FIG>) fluidically coupled to the flow diversion device <NUM> to enable deployment and/or recapture of a prosthetic heart valve device. The flow diversion device <NUM> and portions thereof can be made of a variety of materials. For example, the housing <NUM> and/or handle <NUM> can be made of a rigid or semi-rigid polymer, plastic, metal, and/or other mechanically robust materials.

The flow diversion device <NUM> includes a plurality of apertures or openings <NUM> (identified individually as first through fourth openings 203a-d, respectively) in the housing <NUM> and a corresponding plurality of connectors or fittings <NUM> (identified individually as first through fourth fittings 206a-d, respectively) at least partially aligned with the openings <NUM>. In the illustrated embodiment, the housing <NUM> includes four openings <NUM>, and four fittings <NUM> are coupled to the housing <NUM> at the corresponding openings <NUM>. In other embodiments, the flow diversion device <NUM> may include fewer than four or more than four openings <NUM> and/or fittings <NUM>. The fittings <NUM> can receive or otherwise fluidically couple to one or more hoses, tubes, fluid lines, and/or other components (e.g., connectors, valves, pumps) that can concurrently deliver and/or remove fluid to/from reservoirs (e.g., the reservoirs <NUM> of <FIG>), fluid chambers in a delivery catheter assembly (e.g., the chambers <NUM> of <FIG> and <FIG>), and/or other components of a delivery system. For example, in the illustrated embodiment, the first and second fittings 206a and 206b can be coupled to tubes in fluid communication with respective chambers <NUM> of the catheter <NUM> (<FIG>). The third fitting 206c can be coupled to a tube in fluid communication with an inflator device (e.g., a reservoir of an indeflator), which is filled with a pressurized fluid that can be passed to one or more chambers <NUM> via the flow diversion device <NUM>. The fourth fitting 206d can be coupled to a tube in fluid communication with a drain line (e.g., reservoir), which can receive fluid drained from one or more of the chambers <NUM> of the catheter <NUM>.

As shown in <FIG>, the flow diversion device <NUM> can include a connection device <NUM> that secures the flow diversion device <NUM> to an inflation mechanism that provides for fluid delivery to portions of the delivery catheter <NUM> (<FIG>) and/or other portions of a delivery system (e.g., the system <NUM> of <FIG>) The connection device <NUM> can include bracket <NUM> and a knob <NUM> operably coupled to a compression member <NUM> (e.g., a screw) that adjusts the sizing of the bracket <NUM> to clamp onto a portion of the delivery system. Referring to <FIG>, for example, the connection device <NUM> can be positioned such that the bracket <NUM> extends around a portion of an inflator device <NUM> and the knob <NUM> can be rotated to adjust the sizing of the bracket <NUM> (e.g., adjusting the position of a screw) such that the connection device <NUM> applies pressure to the inflator device <NUM> to secure the inflator device <NUM> and the flow diversion device <NUM> together. In the embodiment illustrated in <FIG>, the connection device <NUM> couples to a fluid reservoir <NUM> of the inflator device <NUM>. In this and other embodiments, however, the connection device <NUM> can couple to other portions of the inflator device <NUM> or other portions of a delivery system. In other embodiments, the connection device <NUM> can removably secure the flow diversion device <NUM> to an inflator device and/or other component by an automatically adjustable spring-loaded engagement arms, a lever clamping mechanism, adhesives, and/or other suitable attachment means.

<FIG> and <FIG> illustrate partial cross-sectional views of the flow diversion device <NUM> of <FIG> and <FIG> in two different configurations in accordance with embodiments of the present technology. Specifically, <FIG> illustrates a first arrangement that facilitates passing fluid to a first chamber of a hydraulic delivery system and from a second chamber of the delivery system (e.g., the chambers <NUM> of the delivery system <NUM> of <FIG> and <FIG>). <FIG> illustrates a second arrangement that facilitates fluid flow in the inverse direction of the first arrangement such that fluid flows from the first chamber and to the second chamber. The flow diversion device <NUM> provides for the change in direction and/or path of fluid flow of the delivery system to deploy and/or recapture a prosthetic heart valve device.

As shown in <FIG> and <FIG>, the housing <NUM> defines or contains a network of channels <NUM> that intersect at a junction structure <NUM>, and the openings <NUM> and associated fittings <NUM> define the inlets and/or outlets for the network of channels <NUM>. The junction structure <NUM> can be define by internal surfaces or walls of the housing <NUM> that create a hole (e.g., a borehole) and/or a separate open tube or structure extending through a portion of the housing <NUM>. A flow control component <NUM> is disposed at the junction structure <NUM> and movable in a longitudinal and/or rotational manner within the junction structure <NUM> to selectively form a plurality of different fluid pathways <NUM> (shown in broken lines; identified individually as first through fourth pathways 218a-d, respectively) based on the orientation of the flow control component <NUM> to the channels <NUM>. The flow control component <NUM> can be a shaft or other structure with a plurality of openings and fluid channels <NUM> extending therethrough such that relative movement of flow control component <NUM> within the junction structure <NUM> can align one, two, or more selected fluid channels <NUM> of the flow control component <NUM> with selected channels <NUM> of the housing <NUM> in fluid communication with the openings <NUM>. In various embodiments, the flow control component <NUM> can include different or additional structures or features that allow selective activation of fluid pathways <NUM> through the flow diversion device <NUM>. In some embodiments, the diameters of the flow control component <NUM> relative to the junction structure <NUM> is selected to avoid excessive fluid flow between the fluid control component <NUM> (e.g., a shaft) and the inner wall of the junction structure <NUM> (e.g., the interior surface defining a borehole) that could adversely affect fluid delivery to the delivery catheter. The fluid control component <NUM> and junction structure <NUM> can be made of a variety of materials that are mechanically robust yet reduce friction. For example, the fluid control component <NUM> can be made of a polycarbonate material and the junction structure <NUM> can be made of metal (e.g., steel), and the two features can be coated with a substance that reduces friction therebetween.

In some embodiments, the junction structure <NUM> includes a plurality of sealing members <NUM> (identified individually as first through fourth sealing members 226a-d, respectively) disposed at various locations along the flow control component <NUM> to form sealed compartments (i.e., between the sealing members 226a)-d. In the illustrated embodiment, the sealing members <NUM> are O-rings (e.g., coated rubber O-rings) disposed around the outer surface of the fluid control component <NUM> (e.g., a shaft) and in contact with the inner wall of the junction structure <NUM> (e.g., the interior surface defining a borehole). In some embodiments, at least some of the sealing members <NUM> can be different structures that provide sealing between portions of the flow control component <NUM> and the junction structure <NUM>, yet still allow the flow control component <NUM> to move relative to the junction structure <NUM>. Movement of the flow control component <NUM> relative to the junction structure <NUM> moves the compartments between the plurality of sealing members <NUM> into or out of alignment with the channels <NUM> to selectively form the pathways <NUM>.

In <FIG>, the flow control component <NUM> is arranged in a first position to define the first and second pathways 218a-b that provide fluid communication via the network of channels <NUM> between the openings <NUM>. In the illustrated embodiment, the flow control component <NUM> is placed in the first position by moving longitudinally along the junction structure <NUM> in the direction of arrow <NUM>.

In <FIG>, the flow control component <NUM> is arranged in a second position to define the pathways third and fourth 218c-d that provide fluid communication via the network of channels <NUM>. The flow control component <NUM> is placed in the second position by moving longitudinally in the direction of arrow <NUM> relative to the first position of the flow control component <NUM> shown in <FIG>.

As shown in <FIG> and <FIG>, the opening 203c associated with the third fitting 206c defines an inlet of the first pathway 218a when the flow control component <NUM> is in the first position (<FIG>), and is likewise an inlet to the third pathway 218c when the fluid control component <NUM> is in the second position (<FIG>). As such, the third fitting 218c can be coupled to a fluid delivery device (e.g., an inflator) in communication with a fluid reservoir (e.g., the first reservoir 114a of <FIG>) that can supply pressurized fluid to the flow diversion device <NUM> and therefrom to either a first chamber or a second chamber of a delivery system (e.g., chambers <NUM> of the system <NUM> of <FIG>), depending on the position of the fluid control component <NUM>. Accordingly, the third fitting 206c and associated opening 203c can define an inlet regardless of whether the delivery system is in a deployment mode or a recapture mode. In addition, the opening 203d of the fourth fitting 206d can define an outlet of the second pathway 218b when the fluid control component <NUM> is in the first position (<FIG>), and can also define an outlet of the fourth pathway 218d when the fluid delivery component <NUM> is in the second position (<FIG>). As such, the fourth fitting 206d the associated opening 203d can be coupled to a drain line or fluid receptacle that receives fluid from any of the chambers of the delivery catheter via the flow diversion device <NUM>, regardless of the arrangement of the fluid control component <NUM>. Accordingly, the fluid control device <NUM> enables the interchange between fluid delivery to and from different chambers of a delivery system without needing to move the position of the fluid delivery component or the fluid drainage component. Further, the fluid control device <NUM> enables this fluid interchange with a simple manipulation of a single component (i.e., the handle <NUM>) and without undue force on the part of the clinician implementing the change between delivery and recapture of the implantable device.

Although described in terms of certain inlets or outlets of the flow diversion device <NUM> being configured to pass fluid in certain directions depending on the position of the flow control component <NUM>, a person skilled in the art would understand that this is a relative arrangement of interconnections that could be achieved with a different arrangement of interconnections. For example, the description of the relative fluid flow between the flow diversion device <NUM> can be changed by swapping the connections between the two chambers such that, for example, the second chamber is filled and the first chamber is drained when the flow control component <NUM> is in the first position.

The flow control component <NUM> can be operably coupled to the handle <NUM> and/or other control structure such that manipulation of the handle <NUM> (e.g., toggling, turning, pushing) moves the orientation of the flow control component <NUM> within the junction structure <NUM> to the predefined first and second positions. In some embodiments, the handle <NUM> is operably coupled to the flow control component <NUM> via a pin and/or other connection structure, and rotatable about an axis <NUM> to position. Rotation of the handle <NUM> about the axis <NUM> to predetermined positions (e.g., first and second handle positions) can move the flow control component <NUM> to the first position (e.g., <FIG>) and the second position (e.g., <FIG>). In the illustrated embodiment, the first handle position (<FIG>) is a <NUM>-degree rotation of the handle <NUM> from the neutral position, and the second handle position (<FIG>) is a <NUM>-degree rotation of the handle <NUM> from the first handle position. In some embodiments, the handle <NUM> can rotate different degrees about the axis <NUM> to implement the different positions of the flow control component <NUM>, the handle <NUM> can have additional positions that correlate to additional positions of the flow control component <NUM>, and/or the handle <NUM> can be manipulated in a different or additional manner to effectuate movement onto the flow control component <NUM>.

<FIG> are partially schematic, functional illustrations of the flow diversion device <NUM> of <FIG> that further illustrate the interaction of the fluid control component <NUM> with the junction structure <NUM> to create the various fluid pathways <NUM> via the network of channels <NUM> (<FIG> and <FIG>). <FIG> illustrates the flow diversion device <NUM> in the first or deploy configuration, and <FIG> illustrates the flow diversion device <NUM> in the second or recapture configuration.

As shown in <FIG>, when the flow diversion device <NUM> is in the deploy configuration, the flow control component <NUM> is in the first position. The flow control component <NUM> can be moved to this position by manipulating the handle <NUM> (<FIG>) to a predetermined position, which causes the flow control component <NUM> to move in the direction of the arrow <NUM>. In the first position, the flow control component <NUM> forms the first and second pathways 218a and 218b. The first pathway 218a can place an inflator device with a fluid reservoir (e.g., the first reservoir 114a of <FIG>) in fluid communication with a deployment chamber in a portion of a delivery catheter (e.g., one of the chambers <NUM> of <FIG>). The second pathway 218b can place a resheathe chamber of the delivery catheter (e.g., the other of the chambers <NUM> of <FIG>) with a drain or receptacle reservoir (e.g., the second reservoir 114b of <FIG>). Thus, in the deploy configuration, the flow diversion device <NUM> allows for filling of the deploy chamber via the inflator device via the first pathway 218a, and removal of fluid from the resheathe chamber to the drain line via the second pathway 218b. In some embodiments, the flow diversion device <NUM> allows for concurrent fluid delivery to and removal from the delivery catheter, and in other embodiments these steps are performed sequentially. This fluid delivery to one chamber of the delivery system and removal from another chamber of the delivery system can initiate unsheathing of a delivery capsule from an implantable device (e.g., a prosthetic heart valve) to allow for expansion and/or deployment of the device within the body.

As shown in <FIG>, when the flow diversion device <NUM> is in the recapture configuration, the flow control component <NUM> is in the second position. The flow control component <NUM> can be moved from a neutral position or the first position (<FIG>) to the second position by manipulating the handle <NUM> (<FIG>) to a predetermined position, which causes the flow control component <NUM> to move in the direction of the arrow <NUM>. In the second position, the flow control component <NUM> defines the third and fourth pathways 218c and 218d using at least some the same channels <NUM> (<FIG>) as in the deploy configuration, but redefining the connections therebetween. The third pathway 218c can place the inflator device in communication with the resheathe chamber of the delivery catheter to allow for fluid delivery to the resheathe chamber. The fourth pathway 218d can place the deploy chamber of the delivery catheter in fluid communication with a drain line to allow fluid removal from the deploy chamber. This fluid delivery to one chamber of the delivery system and fluid removal from another chamber of the delivery system, performed in an opposite manner as in the deploy configuration, can initiate resheathing or recapture of an at least partially deployed device (e.g., a prosthetic heart valve) and/or closing of a delivery capsule before removal of the delivery system from the body.

<FIG> are top views of a flow diversion device <NUM> in various different flow arrangements in accordance with other embodiments of the present technology, and <FIG> is an exploded view of the flow diversion device <NUM> of <FIG>. Similar to the flow diversion device <NUM> of <FIG>, the flow diversion device <NUM> of <FIG> is configured to control the pathways and direction of fluid flow in a hydraulic delivery system (e.g., the system <NUM> of <FIG>) to deploy and/or recapture a prosthetic heart valve and/or other implantable device. The flow diversion device <NUM> includes a housing <NUM> coupled to a control mechanism or handle <NUM>. The housing <NUM> can include a plurality of channels <NUM> (identified individually as first through fourth channels 260a-260d, respectively) that terminate at a plurality of openings <NUM> (identified individually as first through fourth openings 256a-d, respectively) accessible via the exterior of the housing <NUM> and intersect at a junction structure <NUM>. The handle <NUM> can be rotated or otherwise moved to at least two different positions to selectively alter fluid pathways defined along the channels <NUM>, and thereby allowing fluid delivery to and from two chambers of a delivery system, thereby enabling deployment and recapture of an implantable device from a delivery capsule of the delivery system.

The flow diversion device <NUM> can be made from a variety of different rigid, semi-rigid, or flexible materials. For example, the housing <NUM> can be made of injection molded plastic or another rigid material that is mechanically robust. The handle <NUM> and other components of the flow diversion device <NUM> can likewise be made of a polymer, metal, and/or other mechanically robust material.

In the illustrated embodiment, the housing <NUM> defines four openings <NUM> corresponding to the four channels <NUM> extending from the junction structure <NUM>. In other embodiments, the housing <NUM> can include fewer than four or more than four openings <NUM>. In this and other embodiments, the housing <NUM> can include fewer than four or more than four channels <NUM> intersecting the junction structure <NUM>. Each opening <NUM> can receive one or more hoses, tubes, or other components (e.g., connectors, valves, pumps) for transporting a flowable substance (e.g., liquid, saline solution, water) between fluid reservoirs, drain lines, and chambers of located in a delivery capsule, along a catheter, in a handle of the catheter, and/or in other portions of a hydraulic delivery system. For example, the first and second openings 256a and 256b can receive tubes that fluidically connect the flow diversion device <NUM> to respective chambers of the delivery catheter. The third opening 256c can receive a tube that fluidically connects the flow diversion device <NUM> to a drain or reservoir configured to receive fluid removed from one or more chamber(s) of the delivery catheter. The fourth opening 256d can receive a tube that fluidically connects the flow diversion device <NUM> to a fluid reservoir, such as a fluid reservoir of an inflator device (e.g., the inflator device <NUM> of <FIG>), which can be delivered to the chamber(s) of the delivery catheter. Accordingly, the openings <NUM> can define inlets and/or outlets of the network of channels <NUM> from/to components external to the flow diversion device <NUM>.

As shown in the partially exploded views of <FIG>, the flow diversion device <NUM> can further include a flow control component <NUM> disposed at least partially within the junction structure <NUM> and operably coupled to the handle <NUM>. In the illustrated embodiment, the junction structure <NUM> includes a central tubular structure <NUM>, a plurality of tubular arms <NUM> extending from radially outward from the central tubular structure <NUM> in alignment with corresponding plurality of channels <NUM>, and a junction aperture <NUM> configured to receive the flow control component <NUM>. The central tubular structure <NUM> and tubular arms <NUM> can be securely contained in the housing <NUM> of the flow diversion device <NUM> when j oining an upper housing portion 252a and a lower housing portion 252b. In other embodiments, the junction structure <NUM> can be integrally formed (e.g., molded) with the housing <NUM> and/or otherwise secured within the housing <NUM>. In this and other embodiments, the junction structure <NUM> can have different configurations, such a s a single tubular shaft without tubular arms, a tube with arms spaced in different configurations than shown, and/or other suitable junction mechanisms for supporting the flow control component <NUM> and interfacing with the channels <NUM>.

The flow control component <NUM> includes a body portion <NUM>, such as a shaft or other structure, that is rotatably received within the aperture <NUM> of the junction structure <NUM>. The body portion <NUM> includes one or more diversion channels <NUM> (e.g., two diversion channels, three diversion channels, four diversion channels, more than four diversion channels) that traverse the body portion <NUM>. The diameter(s) of the diversion channels <NUM> are such that they can facilitate suitable pressures and speeds of fluid delivery to the catheter.

During use, rotation of the handle <NUM> causes the flow control component <NUM> to rotate with respect to the junction structure <NUM>. This rotation causes the diversion channels <NUM> of the flow control component <NUM> to align with the main channels <NUM> in the housing <NUM>, and thereby selectively define a plurality of fluid pathways <NUM> (identified individually as first through fifth fluid pathways 264a-e, respectively; <FIG>). For example, rotation of the handle <NUM> can rotate the body portion <NUM> of the flow control component <NUM> between at least a first position (e.g., deploy configuration) and a second position (e.g., recapture configuration) such that the diversion channels <NUM> are selectively aligned with the main channels <NUM> to enable fluid flow for device delivery and recapture.

During use, the flow diversion device <NUM> can have two or more functional configurations for delivering fluid to and from different components of the delivery systems. In the embodiment illustrated in <FIG>, the flow diversion device <NUM> has three functional configurations: a deploy configuration shown in <FIG>, a recapture configuration shown in <FIG>, and an intermediate fill configuration shown in <FIG> for optional refilling of an inflator device during a delivery procedure. The flow diversion device <NUM> may also have fourth configuration in which all the channels <NUM> are blocked.

Referring to <FIG>, when the flow diversion device <NUM> is in the deploy configuration, fluid can flow along a second pathway 262b from an inflator device (e.g., the inflator device <NUM> of <FIG>) or other fluid reservoir, into the fourth opening 256d, through the junction structure <NUM> and the flow control component <NUM> (<FIG>) therein, out of the second opening 256b, and into a chamber (e.g., a deploy chamber) of a delivery catheter. In some embodiments, the deploy configuration allows fluid to simultaneously or concurrently drain along the first pathway 262a, in which fluid can flow from a resheathe chamber of the delivery catheter, into the first opening 256a, through the junction structure <NUM> and the flow control component <NUM>, through the third opening 256c, and into a drain line and/or reservoir.

As shown in <FIG>, when the flow diversion device <NUM> is in the recapture configuration, fluid can flow along a fourth pathway 262d from the inflator device into the fourth opening 256d, through the junction structure <NUM> and the flow control component <NUM> therein, through the first opening 256a, and into a resheathe chamber of the delivery catheter. In some embodiments, the recapture configuration also allows fluid to be removed from the deploy chamber of the delivery catheter via the third pathway 262c. In this arrangement, fluid can flow from the deploy chamber, into the second opening 256b, through the junction structure <NUM> and the flow control component <NUM> therein, through the third opening 256c, and into the drain reservoir or line. Thus, the recapture state of the flow diversion device <NUM> shown in <FIG> illustrates a counterpart to the deployment state of the flow diversion device shown in <FIG>, allowing fluid to move in opposite directions from respective chambers of the delivery catheter by rotating the handle <NUM> (and the flow control component <NUM> coupled thereto) from a first position shown in <FIG> to a second position shown in <FIG>.

In both the deployment and recapture configurations of the flow diversion device <NUM>, the fourth opening 256d defines an inlet to the flow diversion device <NUM>, whether that be for the second pathway 262b used during the deploy configuration or the fourth fluid pathway 262d used during recapture. As such, the fourth opening 256d can be coupled to an inflator device, such as a device that includes a pressurized fluid for delivery to the flow diversion device <NUM> and either the first chamber or the second chamber of the delivery catheter, depending on the configuration of the flow control component <NUM>. Similarly, the third opening 256c defines an outlet of the flow diversion device <NUM> for each of the first and third pathways 262a and 262c when the flow diversion device <NUM> is in either the deploy configuration (<FIG>) or the recapture configuration (<FIG>), respectively. As such, the third opening 256c can be coupled to a reservoir, receptacle, and/or drain that can receive fluid from either the first chamber of the second chamber, depending on the configuration of the flow diversion device <NUM>.

As shown in <FIG>, when the flow diversion device <NUM> is in an optional fill configuration, the flow diversion device <NUM> allows fluid to flow along the fifth pathway 262e from the third opening 256c to the fourth opening 256d to place the inflator device or reservoir in communication with a fluid reservoir (e.g., a drainage reservoir) to allow for refilling of the inflator device. In various embodiments, this intermediate configuration can be employed when initiating the delivery system (e.g., the system <NUM> of <FIG>), before device deployment or recapture. For example, during initial set up, the inflator device can be filled via the fifth pathway 262e used to flush the delivery system to remove air pockets. This may deplete the fluid supply contained in the inflator device such that it is insufficient for deployment and/or recovery procedures. Accordingly, the fill configuration of <FIG> enables rapid refill of the inflator device or fluid reservoir without the need to detach the inflator device from the flow diversion device <NUM>. In various embodiments, this fill configuration can also be used during the delivery procedure if additional fluid is needed for device delivery, flushing, and/or recapture.

Although described in terms of certain openings of the flow diversion device <NUM> configured to pass fluid in certain directions depending on the position of a flow control component, a person skilled in the art would understand that this is a relative arrangement of interconnections that could be achieved with other arrangements of interconnections. For example, the description of the relative fluid flow between the flow diversion device <NUM> can be changed by swapping the connections between the two chambers.

In some embodiments, the flow diversion device <NUM> can also include a connection assembly <NUM> (comprising parts 258a and 258b) that can releasably secure the flow diversion device <NUM> to a portion of the delivery system (e.g., the inflator device <NUM> of <FIG>). The connection assembly <NUM> can be a bracket structure that applies resistive forces to the component held within the connection assembly <NUM>. As shown in <FIG>, for example, the connection assembly <NUM> formed by joining a first bracket surface portion 275a and a second bracket surface portion 275b on opposing sides of the housing <NUM>. As shown, the bracket surface portions <NUM> can have a large surface area to enhance the grip on the inflator device. In other embodiments, the connection assembly <NUM> can include different attachment mechanisms for releasably secure the flow diversion device <NUM> to other components of the delivery system.

Although described with reference to applications that involve implanting prosthetic valve devices, the disclosed embodiments are not so limited. For example, embodiments of the disclosed flow diversion devices described above with reference to <FIG> can be configured to cause delivery of various other medical devices in addition, or alternative, to prosthetic valve devices for replacement of the mitral valve and/or other valves in the heart of the patient. Specific elements, substructures, advantages, uses, and/or other features described herein can be suitably interchanged, substituted or otherwise configured with one another. Furthermore, suitable elements of the embodiments described can be used as stand-alone and/or self-contained devices.

Claim 1:
A flow diversion device (<NUM>, <NUM>) for controlling fluid flow in a delivery system (<NUM>) to deploy a prosthetic heart valve device (<NUM>), the flow diversion device comprising:
a housing (<NUM>, <NUM>) including:
a plurality of channels (<NUM>) that intersect at a junction (<NUM>, <NUM>), and
a plurality of openings (<NUM>, <NUM>) of the plurality of channels in fluid communication with the junction, wherein the plurality of openings includes a first opening (185a, 203a) and a second opening (185b, 203b),
a flow control component (<NUM>, <NUM>) disposed at the junction and movable to selectively form a plurality of pathways (<NUM>, <NUM>) including a first pathway (182a, 218a) and a second pathway (182b, 218b) for fluid communication via the plurality of channels between the plurality of openings based on a position of the flow control component, wherein:
when the flow control component is in a first position, the first pathway is formed to allow fluid flow through at least the first opening toward a first chamber (144a) of the delivery system to cause deployment of the prosthetic heart valve device, and
when the flow control component is in a second position, the second pathway is formed to allow fluid flow through at least the second opening toward a second chamber (144b) of the delivery system to cause recapture of the prosthetic heart valve device, and
a handle (<NUM>, <NUM>) operably coupled to the flow control component and movable to position the flow control component in at least either the first position and the second position to selectively allow fluid flow toward at least either the first chamber or the second chamber of the delivery system.