Patent Description:
The present technology relates generally to hydraulic delivery systems for implanting medical devices. In particular, several embodiments of the present technology are related to cam-based fluid diversion devices for hydraulic delivery systems for deploying medical and associated methods.

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-Sapien® Valve from Edwards Lifesciences (Irvine, CA, USA). Both valve systems include an expandable frame and a tri-leaflet bioprosthetic valve attached to the expandable frame. The aortic valve is substantially symmetric, circular, and has a muscular annulus. The expandable frames in aortic applications have a symmetric, circular shape at the aortic valve annulus to match the native anatomy, but also because tri-leaflet prosthetic valves require circular symmetry for proper coaptation of the prosthetic leaflets. Thus, aortic valve anatomy lends itself to an expandable frame housing a replacement valve since the aortic valve anatomy is substantially uniform, symmetric, and fairly muscular. Other heart valve anatomies, however, are not uniform, symmetric or sufficiently muscular, and thus transvascular aortic valve replacement 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> describes a delivery system with telescoping capsules for deploying prosthetic heart valve devices.

In some examples, the disclosure describes a fluid diversion device for controlling fluid flow in a delivery system to deploy a prosthetic heart valve device, the fluid diversion device comprising: a housing including a first side, a second side, a bore, and a plurality of channels traversing the housing from the first side through the bore to the second side, wherein the plurality of channels are configured to receive a corresponding plurality of tubes that extend from the first side through the bore to the second side of the housing, and wherein the bore extends laterally across the plurality of channels; an occlusion member disposed in the bore, wherein rotation of the occlusion member enables selective occlusion of either a first subset of tubes or a second subset of tubes disposed in the plurality of channels; and an actuator operably coupled to the occlusion member to enable selective positioning of the occlusion member in at least a first position that occludes the first subset of tubes and a second position that occludes the second subset of tubes for fluid communication in different directions relative to a first chamber and a second chamber of a delivery device to cause deployment and recapture of the prosthetic heart valve device.

In some examples, the disclosure describes a system for delivering a prosthetic heart valve device into a heart of a patient, the system comprising: 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; a plurality of chambers including a first chamber and a second chamber operable to receive or expel fluid to hydraulically drive deployment and recapture of the prosthetic heart valve device; and a fluid diversion device including: a housing including a first side, a second side, a bore, and a plurality of channels traversing the housing from the first side through the bore to the second side, wherein the plurality of channels is configured to receive a corresponding plurality of tubes that extend from the first side through the bore to the second side of the housing, and wherein the bore extends laterally across the plurality of channels, an occlusion member disposed in the bore, wherein rotation of the occlusion member enables selective occlusion of either a first subset of tubes or a second subset of tubes disposed in the plurality of channels, and an actuator operably coupled to the occlusion member to enable selective positioning of the occlusion member in at least a first position that occludes the first subset of tubes and a second position that occludes the second subset of tubes for fluid communication in different directions relative to the first chamber and the second chamber to cause deployment and recapture of the prosthetic heart valve device.

In some examples, the disclosure describes a fluid diversion device for controlling fluid flow in a delivery system to deploy a medical device, the fluid diversion device comprising: a housing including a plurality of channels configured to receive a corresponding plurality of tubes, and a bore that extends laterally across the plurality of channels; an occlusion member disposed in the bore, wherein rotation of the occlusion member selectively occludes either a first subset of tubes from the plurality of tubes or a second subset of tubes from the plurality of tubes; and an actuator configured to enable rotation of the occlusion member to at least a first position and a second position such that the first subset of tubes and the second subset of tubes are alternatively occluded in the first position or the second position for fluid communication in different directions relative to a plurality of chambers of a delivery device operable to deploy and recapture the medical device.

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 fluid diversion devices of hydraulic delivery systems 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 prosthetic valves to other sites, such as the tricuspid valve or the aortic valve. In addition, the present technology may be used to deliver cardiac valve repair devices and/or other medical devices to target sites within the body. 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 fluid diversion devices of delivery systems 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 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 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 fluid 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 fluid diversion devices poses a physical and cognitive burden on a clinician, which increases the risks associated with replacement procedures.

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 valve replacement device. The disclosed embodiments include a fluid 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 fluid diversion device.

The disclosed embodiments overcome the aforementioned drawbacks with fluid diversion devices of dual-hydraulic delivery systems that can readily and reliably deploy and/or recapture valve replacement devices. For example, a fluid diversion device of the disclosed embodiments can implement a cam mechanism that can be rotated with a handle 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 provide 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 fluid 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 fluid 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). 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 (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 invention 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 at the correct target position relative to the native annulus, leaflets, left atrium, and the left ventricular outflow tract (LVOT). For example, the hydraulically controlled movement of a delivery capsule can reduce, limit, or substantially eliminate uncontrolled deployment 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 fluid diversion devices described herein facilitate changing from deployment and recapture configurations in an efficient manner. For example, instead of requiring physical manipulation of multiple handles of multiple interconnected stopcocks in a complex pattern, the disclosed fluid diversion devices require less manual adjustments to change the direction of fluid flow within the delivery system and switch between deploy and recapture configurations. In some embodiments, for example, a fluid diversion device has a handle that can rotate an occlusion mechanism to change the fluid diversion device between two positions to initiate deployment or recapture of a prosthetic heart valve device. As such, the disclosed devices can 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 system.

<FIG> is a partially schematic isometric view of a hydraulic delivery system <NUM> ("system <NUM>") for deploying a prosthetic heart valve device 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> has a proximal portion 108a coupled to a handheld control unit <NUM> (e.g., a handle) 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 fluid 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 fluid diversion device <NUM>. For example, the control assembly <NUM> can include buttons, handles, 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. The housing <NUM> can be made of one, two, or more components that at least partially enclose the prosthetic heart valve device <NUM> therein. The housing <NUM> can include a distal end portion <NUM> can have an opening <NUM> through which the guidewire <NUM> can be threaded to allow for guidewire delivery to the target site. As shown in <FIG>, the distal end portion <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> can be made of metal, polymers, plastic, composites, combinations thereof, or other materials capable of holding the prosthetic heart valve device <NUM>.

When the distal portion 108b of the elongated catheter body <NUM> is delivered to a target location, the control unit <NUM> and/or the fluid diversion device <NUM> can be used to hydraulically drive the delivery capsule <NUM> from a containment configuration for holding the prosthetic heart valve device <NUM> towards a deployment configuration to partially or fully deploy and expand the prosthetic heart valve device <NUM> from the delivery capsule <NUM>. For example, the delivery capsule <NUM> can be hydraulically driven towards the deployment configuration by supplying a flowable liquid to a chamber of the system <NUM> while also removing a flowable liquid from a separate chamber. These fluid chambers can be positioned in the delivery capsule <NUM>, along the elongated catheter body <NUM>, in the handheld control unit <NUM>, and/or elsewhere in the system <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.

The catheter <NUM> is also configured to partially or fully resheathe the prosthetic heart valve device <NUM> after partial deployment from the delivery capsule <NUM>. For example, the delivery capsule <NUM> can be hydraulically driven back towards the containment configuration (e.g., recaptured) by transferring fluid into one chamber and removing fluid from another chamber in an opposite manner as that used for deployment. The resheathing (also referred to as recapturing herein) ability allows a 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 delivery capsule <NUM> and the catheter <NUM> can be drawn proximally through a guide catheter for removal from the patient. After removing the catheter <NUM>, it can be cleaned and used to deliver additional prosthetic devices or it can be discarded.

The fluid diversion device <NUM> is fluidically coupled to the catheter <NUM> via the fluid line(s) <NUM>. The fluid diversion device <NUM> is also fluidically coupled to one or more reservoirs <NUM> (identified as a first reservoir 114a and a second reservoir 114b) that can contain a flowable substance (e.g., water, saline) used to hydraulically drive positioning of the prosthetic heart valve device <NUM> by controlling fluid flow into a chamber while removing fluid from another chamber of the system <NUM> The reservoirs <NUM> may include an inflator device with pressurized fluid and a drain configured to receive drained fluid. The fluid diversion device <NUM> can include one or more hoses, tubes, or other components (e.g., fittings, connectors, valves) through which a fluid can pass from the reservoir(s) to the catheter <NUM>, and/or through which the fluid can drain from the catheter <NUM> to the reservoir(s).

In some embodiments, the fluid lines <NUM> can deliver fluid to the catheter <NUM> from the second reservoir 114b via the fluid diversion device <NUM>. The fluid lines <NUM> can also drain fluid from the catheter <NUM> to the first 114a via the fluid diversion device <NUM>. In some embodiments, the fluid source may include one or more pressurization devices (e.g., inflator device, pump) fluidically coupled to the fluid diversion device <NUM>, which can also include one or more fluid connectors, fittings, valves, and/or other fluidic components that facilitate moving the fluid to and/or from fluid reservoirs <NUM>. The movement of fluid to and from the fluid diversion device <NUM> can be used to deploy the prosthetic heart valve device <NUM> from the delivery capsule <NUM> and/or resheathe the prosthetic heart valve device <NUM> after at least partial deployment.

As explained in greater detail below, the fluid diversion device <NUM> includes a flow control component that controls fluid to and from the catheter <NUM>. In some embodiments, the flow control component can be disposed within an elongated aperture (e.g., a bore) extending through the fluid diversion device housing and include one or more cams that can change the direction of fluid flow based on the rotation of the flow control component. Further, the fluid diversion device <NUM> can include an actuator, such as a handle <NUM>, that allows a clinician to control deployment or resheathing of the prosthetic heart valve device <NUM> by rotating the cam The handle <NUM> can be rotated to cause the cam(s) to occlude different tubes as a function of the angle of rotation of the handle <NUM>. In particular, a number of tubes can traverse the cam(s) such that rotation of the cam(s) can occlude fluid flow through a first subset of tubes while leaving a second subset of tubes open. The handle <NUM> can be rotated again to rotate the cam(s) such that fluid flow through the second subset of tubes is occluded while the first subset of tubes is caused to open. This occlusion and opening of specific tubes extending through the fluid diversion device <NUM> can initiate fluid flow in opposite directions to effectuate deployment and resheathing.

In some embodiments, the fluid diversion device <NUM> is 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 still 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>.

<FIG> and <FIG> are enlarged partial cross-sectional views of the 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, the chambers <NUM> can be contained in combinations of the catheter body <NUM> and/or the handheld control unit <NUM>. For example, the deployment chamber 144a may be positioned within the delivery capsule <NUM>, whereas the recapture chamber 144b may be positioned along the catheter body <NUM> and/or within the handheld control unit <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> (<FIG>) and expand such that it may engage surrounding tissue of a native mitral valve. As shown in <FIG>, the housing <NUM> is urged distally back towards the containment configuration to resheathe at least a portion of the prosthetic heart valve device <NUM> when fluid is at least partially drained from the second chamber 144b (as indicated by arrow <NUM>) while fluid is being delivered into the first chamber 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 its proximal end (not shown), the shaft <NUM> is coupled to the fluid 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 end cap <NUM>, and the interior wall of the housing <NUM> extending therebetween. The shaft <NUM> and the flanges <NUM> can be integrally formed or separate components, and can be made from metal, polymers, plastic, composites, combinations thereof, and/or other suitable materials for containing fluids. The flanges <NUM> are fixed with respect to the shaft <NUM>. Sealing members <NUM> (identified individually as first through third sealing members 156a-c, respectively), such as O-rings, can be positioned around or within the flanges <NUM> and/or the platform <NUM> to fluidically seal the chambers 144a-b from other portions of the delivery capsule <NUM>. For example, the first and second sealing members 156a and 156b can be positioned in recesses of the corresponding first and second flanges 154a and 154b to fluidically seal the flanges <NUM> against the interior wall of the housing <NUM>, and the third sealing member 156c can be positioned within a recess of the platform <NUM> to fluidically seal the platform <NUM> to the shaft <NUM>. In other embodiments, the system <NUM> can include additional and/or differently arranged sealing members to fluidically seal the chambers <NUM>.

The fluid lines <NUM> are in fluid communication with a fluid diversion device <NUM> at a proximal portion of the system <NUM>. The fluid diversion device <NUM> has a housing <NUM> that includes channels (not shown) through a junction structure <NUM> (e.g., a bore). The housing <NUM> also includes tubes 182a-d disposed in the channels and coupled to fittings <NUM> (identified individually as fittings 186a-d, respectively) for the tubes 182a-d that traverse the junction structure <NUM>. The fluid diversion device <NUM> includes a flow control component <NUM> (e.g., a shaft) including one or more cam(s) disposed at the junction structure <NUM>. The flow control component <NUM> is rotationally movable to control fluid flow by occluding some of the tubes 182a-d and leaving others open. The fluid diversion device <NUM> can include a handle <NUM> operably coupled to move the flow control component <NUM> between a first position (e.g., containment or recapture configuration) and the second position (e.g., deployment configuration) to selectively allow fluid flow toward the first chamber and draining fluid from the second chamber, or vice versa. By rotating the handle <NUM> between two positions, the flow control component <NUM> can regulate fluid flow to and from the chambers <NUM>.

As shown in <FIG>, when the flow control component <NUM> of the fluid diversion device <NUM> is placed in a first position (e.g., via a handle <NUM>), the flow control component <NUM> defines selected fluid pathways via a plurality of tubes <NUM> (referred to individually as first through fourth tubes <NUM>) to initiate device deployment. For example, in the first position the first tube 182a is open to allow fluid flow through the fittings 186c and 186a toward the second chamber 144b of the system <NUM>, and the second tube 182b is also open to drain fluid from the first chamber 144a while the tube 182b allows fluid flow toward the second chamber 144b. In addition, the flow control component <NUM> can occlude the third and fourth tubes 182c and 182d via one or more cam(s) (not shown) to prevent fluid flow therethrough. The simultaneous or concurrent fluid delivery and removal via the first and second tubes 182a and 182b causes the delivery system <NUM> to move from the containment configuration to deployment configuration to at least partially deploy the prosthetic heart valve device <NUM> from the delivery capsule <NUM>.

As shown in <FIG>, when the flow control component <NUM> is moved to a second position (via the handle <NUM>), the cam is rotated such that the third tube 182c opens to allow fluid to drain from the second chamber 144b and the fourth tube 182d opens to allow fluid to flow through fittings 186d and 186b toward the first chamber 144a. This concurrent movement of fluid from the chambers <NUM> moves 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>.

Accordingly, movement of the fluid control component <NUM> between the first and second positions causes openings <NUM> (identified individually as first through fourth openings 185a-d) and the associated fittings <NUM> of the fluid diversion device <NUM> to alternatively serve as outlets and inlets depending on whether the delivery system <NUM> 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>. In the illustrated embodiment, for example, the first opening 185a and associated first fitting 186a serve 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 serve as an inlet when the flow control component <NUM> is in the first position and serve 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 tube 182a, 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 tube 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 other embodiments, such as when one or both of the chambers <NUM> are positioned distal to the compartment <NUM> housing the prosthetic heart valve device <NUM>, deployment can occur by moving the delivery capsule <NUM> in a distal direction.

In the deployment configuration of <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 tube 182c. As fluid exits the second chamber 144b, fluid is also delivered to the first chamber 144a via 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>. In other embodiments, such as when one or both chambers <NUM> are positioned distal to the compartment <NUM> housing the prosthetic heart valve device <NUM>, resheathing can occur by moving the delivery capsule <NUM> in a proximal direction.

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 handheld control unit <NUM> (<FIG>). The biasing device <NUM> 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> is an isometric view of a fluid diversion device housing <NUM> ("housing <NUM>") of a fluid diversion device (e.g., the fluid diversion device <NUM> of <FIG>) configured in accordance with embodiments of the present technology. The housing <NUM> includes multiple channels <NUM> (identified individually as first through fourth channels 202a-d, respectively) and a junction structure <NUM> that extends laterally across the channels <NUM> The junction structure <NUM> can be defined by internal surfaces or walls of the housing <NUM> that create an aperture (e.g., a borehole) and/or a separate open tube or structure extending through a portion of the housing <NUM>. Thus, the channels <NUM> traverse from a first side 206a of the housing <NUM> through the junction structure <NUM> to a second side 206b of the housing <NUM>. The housing <NUM> can integrate components to collectively form a fluid diversion device for controlling fluid flow through a delivery system (e.g., delivery system <NUM> of <FIG>) to deploy and/or recapture a prosthetic heart valve device (e.g., the prosthetic heart valve device <NUM> of <FIG>), a cardiac repair device, and/or a medical device configured to be delivered elsewhere in the body. In some embodiments, the components are press-fit to the housing <NUM> to reduce or eliminate thread particulates and/or coated with a substance that reduces friction. The housing <NUM> can also include one or more connection structures <NUM> (identified individually as first and second connection structures 208a-b, respectively), such as brackets, that can receive and/or otherwise secure to another portion of the delivery system, such as an inflator device that contains fluid pressurized to flow towards selected chamber(s) of the delivery system. In some embodiments, the connection structures <NUM> can fasten to other features of the delivery system (e.g., other fluid reservoirs, the handheld controller (<FIG>)) and/or structures separate from the delivery systems (e.g., procedure table, device holding tray, support poles).

<FIG> is an isomeric view of a fluid diversion device <NUM> including the housing <NUM> of <FIG> and associated fluid lines or tubes <NUM> (identified individually as first through fourth tubes 212a-d, respectively) configured in accordance with embodiments of the present technology. As shown in <FIG>, the channels <NUM> of the housing <NUM> receive the tubes <NUM> such that the tubes <NUM> extend from the first side 206a through the junction structure <NUM> to the second side 206b of the housing <NUM>. A flow control component <NUM> is disposed in the junction structure <NUM>, and includes one or more occlusion members, such as one or more cams <NUM> (described in further detail below with respect to <FIG>) that can selectively close or open subsets of the tubes <NUM> depending on the rotational position of the occlusion members. In the illustrated embodiment, the end portions of at least some of the tubes <NUM> are coupled to the fittings 220a and 220d that provide for connection to additional fluid lines and/or other components associated with the delivery system. In these and other embodiments, the tubes <NUM> can connect to other components, such as connectors, valves, reservoirs, pumps, other tubes, catheters, and/or other components associated with hydraulic delivery systems.

The fluid diversion device <NUM> can also include an actuator <NUM> operably coupled to the flow control component <NUM>. In the embodiment illustrated in <FIG>, the actuator <NUM> is a rotatable handle that can be manipulated to rotate of the flow control component <NUM> to the deployment position, the recovery position, and/or other positions. Hence, rotation of the handle causes selective positioning of the occlusion members <NUM> in at least a first position that occludes a first subset of the tubes <NUM> and a second position that occludes a second subset of the tubes <NUM> for fluid communication in different directions relative to a first chamber (e.g., a deploy chamber) and a second chamber (e.g., a resheathe chamber) of the delivery system to facilitate deployment and recapture of the prosthetic heart valve device. Thus, the handle can be rotated between at least two positions (e.g., <NUM> degrees between first and second positions) to change the direction of fluid flow relative to delivery system chambers of a coupled to the fluid diversion device <NUM>. In other embodiments, the actuator <NUM> can be a push button, switch, dial, and/or other component that is operably coupled to the flow control component <NUM> and actuated by a user (e.g., a clinician) to adjust the position of the flow control component <NUM>. Further, the actuator <NUM> can be configured withstand mechanical loads applied by clinicians to change the position of the flow control component <NUM>, while providing mechanical stability and reduced friction to decrease the overall effort needed to change the direction of fluid flow.

During operation, fluid can pass from a reservoir (e.g., one of the reservoirs <NUM> of <FIG>) through a selected subset of the tubes <NUM> toward the delivery catheter (e.g., the catheter <NUM> of <FIG>) while fluid is drained through one or more of the other tubes <NUM> to another reservoir. For example, the first and fourth tubes 212a and 212d can be coupled to a drain that receives fluid from the delivery system, and the second and third tubes 212b and 212c to an inflator device (e.g., an indeflator) or other reservoir containing a fluid pressurized that can be delivered to the chambers of the delivery system.

The fluid diversion device <NUM> can be made of a variety of materials. For example, the housing <NUM>, the flow control component <NUM>, the handle <NUM>, and/or the fittings <NUM> can be made of a mechanically robust material, such as a rigid polymer, metal, alloys, etc. The tubes <NUM> can be made of a variety of mechanically robust, yet compressible materials, such as a flexible polymer. The diameter(s) of the channels <NUM> of the housing <NUM> and/or the tubes <NUM> received therein can be selected such that they facilitate suitable pressures and speeds of fluid delivery to the delivery catheter.

<FIG> are top and side views, respectively, of the fluid diversion device <NUM> of <FIG> in a first state or configuration in accordance with embodiments of the present technology. As shown in <FIG>, the channels <NUM> can be arranged at least substantially in parallel to each other as they extend through portions of the housing <NUM>, the flow control component <NUM>, and the junction structure <NUM> (through which the flow control component <NUM> extends). The tubes <NUM> are disposed in the channels <NUM> and coupled to fittings <NUM> (identified individually as first through fourth fittings 222a-d, respectively) that define inlets and/or outlets of the fluid diversion device <NUM>. As further shown in <FIG>, the fluid control component <NUM> can include one or more occlusion members, such as cams <NUM> (identified individually as first through fourth cams 216a-d, respectively). In the illustrated embodiment, the fluid control component <NUM> includes four cams <NUM>, but in other embodiments the fluid control component <NUM> can include one, two, three, or more than four cams <NUM> or other occlusion members for selectively opening and closing the tubes <NUM>. The cams <NUM> may include separation structures that space apart the tubes <NUM> such that the tubes <NUM> remain aligned with the channels <NUM>. The plurality of cams <NUM> can be in line with each other, though rotationally offset from neighboring cams to provide selective occlusion of the tubes based on the rotation of the fluid control component <NUM>. In some embodiments, for example, the first and third cams 216a and 216c can define a first cam subset rotationally aligned with each other, and the second and fourth cams 216b and 216d can define a second cam subset that is rotationally offset from the first cam subset. During use, a user can rotate or otherwise manipulate the actuator <NUM>, which in turn rotates the fluid control component <NUM> about its longitudinal axis, thereby moving the cams <NUM> (via the actuator <NUM>) such that the subsets of cams <NUM> selectively occlude and/or open corresponding subsets of the tubes <NUM>.

When the fluid diversion device <NUM> is in the deployment configuration shown <FIG>, the flow control component <NUM> moves to a first position via rotation of the actuator <NUM>. In the first position, the rotational position of the flow control component <NUM> relative to the channels <NUM> causes the first subset of cams <NUM> (first and third cams 216a and 216c) to open the first and third tubes 212a and 212c, while pinching closed the second and fourth tubes 212b and 212d. Thus, in the first position the cams <NUM> occlude the second and fourth tubes 212b and 212d to prevent fluid flow and allow the first and third tubes 212a and 212c to remain open and allow fluid flow therethrough. In this first position, the cams <NUM> of the fluid diversion device <NUM> create an open fluid pathway through the third tube 212c, which allows fluid to flow from a fluid reservoir (e.g., an inflator device), through the fourth fitting 222d, across the fluid diversion device housing <NUM>, through the second fitting 222b on the opposite side of the housing <NUM>, and into a chamber (e.g., a deploy chamber, the second chamber 156b of <FIG>) of the delivery catheter. Positioning the cams <NUM> of the fluid diversion device <NUM> in the first position also creates an open fluid pathway through the first tube 212a, which allows fluid to flow from another chamber (e.g., a resheathe chamber, the first chamber 156a of <FIG>) of the delivery catheter, through the first fitting 222a, across the housing <NUM>, through the third fitting 222c at the opposite side of the housing <NUM> to a drain or other reservoir that receives fluid exiting the delivery system. Thus, the fluid diversion device <NUM> can provide for the concurrent delivery and removal of fluid from two chambers of the delivery system, which collectively causes unsheathing and deployment of the prosthetic heart valve device.

After at least partial deployment of the prosthetic heart valve device, the user can rotate the actuator <NUM> (e.g., <NUM> degrees) to move the flow control component <NUM> to a second position to allow for recapture of the prosthetic heart valve device (i.e., resheathing) and/or closure of the delivery capsule. For example, <FIG> are top and side views, respectively, of the fluid diversion device <NUM> of <FIG> in a second state or configuration in accordance with embodiments of the present technology. In this second configuration, the flow control component <NUM> rotates to a second position relative to the channels <NUM>, which causes the first subset of cams <NUM> to pinch or otherwise occlude the first and third tubes 212a and 212c, while the second subset of cams <NUM> allows fluid flow through the second and fourth tubes 212b and 212d.

In the second position, the cams <NUM> create an open fluid pathway through the second tube 212b, which allows fluid to flow from a fluid reservoir (e.g., the inflator device), through the fourth fitting 222d, across the housing <NUM>, through the first fitting 222a, and into the resheathe chamber (e.g., the first chamber 156a of <FIG>) of the delivery catheter. Positioning the cams <NUM> of the fluid diversion device <NUM> in the section position also creates an open fluid pathway through the fourth tube 212d, which allows fluid to flow from the deploy chamber, through the second fitting <NUM>, across the housing <NUM>, through the third fitting 222c, and into the drain or other reservoir for receiving fluid. Thus, in operation, resheathing or closure of the delivery capsule occurs by fluid being delivered to the resheathe chamber via the second tube 212b, while fluid is drained from the deploy chamber via the fourth tube 212d.

In the embodiment illustrated in <FIG>, the second and third tubes 212b and 212c serve as fluid delivery pathways extending to either the deploy chamber or recapture chamber of the delivery catheter (depending upon the position of the fluid control component <NUM>), and the fourth fitting 222d connected to the second and third tubes 212b and 212c serves as an inlet for the fluid delivery pathways. This is true when the fluid control component <NUM> is rotated to both the first position or the second position, and therefore the fourth fitting 222d and the second and third tubes 212b and 212c can be coupled to a fluid supply reservoir (e.g., an inflator device) to provide fluid for the delivery system chambers. Similarly, the first and fourth tubes 212a and 212d can serve as fluid removal pathways extending away from either the deploy chamber or recapture chamber of the delivery catheter, and the third fitting 222c connected thereto can serve as an outlet of the fluid removal pathways, regardless of the position of the flow control component <NUM>. Therefore, the third fitting 222c and the first and fourth tubes 212a and 212d can be coupled to a drainage reservoir that receives fluid removed from the delivery system chambers or an opening that allows the fluid to flow out of the delivery system.

As further shown in <FIG>, the first fitting 222a can be coupled to the two tubes 212a, 212b in fluid communication with the resheathe chamber such that the first fitting forms an inlet through the first tube 212a or an outlet through second tube 212b depending on whether the flow control component <NUM> is in the first position or the second position. Similarly, the second fitting 222b can be coupled to the two tubes 212c, 212d in fluid communication with the deploy chamber such that the second fitting 222b forms an inlet through fourth tube 212d or an outlet through third tube 212c depending on whether the flow control component <NUM> is in the first position or the second position.

Although the fittings <NUM> and tubes <NUM> are described in terms of certain fluid directions through the fluid diversion device <NUM> depending on the position of the fluid control component <NUM>, a person skilled in the art would understand that this is a relative arrangement that could be achieved with a different arrangement of components. For example, the description of the fluid flow of the fluid diversion device <NUM> can be changed by swapping the connections between the two fluid chambers of the delivery such that, for example, the recapture chamber is filled and the deploy chamber is drained when the flow control device <NUM> is in the first position. Moreover, although the fluid diversion device <NUM> is shown with four tubes <NUM> disposed in four channels <NUM>, other embodiments can include fewer than four or more than four tubes <NUM> and/or channels <NUM>.

<FIG> illustrate a process for attaching an inflator device <NUM> (e.g., an indeflator) to the housing <NUM> of the fluid diversion device <NUM> in accordance with embodiments of the present technology. As shown in <FIG>, the first and second bracket structures 208a and 208b that extend from the housing <NUM> can receive an end portion of the inflator device <NUM> (as indicated by the arrow). As shown in <FIG>, the inflator device <NUM> can mate with complimentary or interlocking surfaces of the bracket structures <NUM> to physically secure the inflator device <NUM> to the housing <NUM> during operation of the fluid diversion device <NUM>. In some embodiments, the bracket structures <NUM> can include a knob that can be rotated or otherwise actuated to clamp the bracket structures <NUM> and/or another securing feature (e.g., a bolt) to the inflator device <NUM> to physically secure the two components together. In some embodiments, the fluid diversion device <NUM> can include additional or alternative connectors to secure the housing <NUM> to the inflator device <NUM>.

<FIG> are front and back isometric views, respectively, of a fluid diversion device housing <NUM> ("housing <NUM>") configured in accordance with embodiments of the present technology. The housing <NUM> can include certain features generally similar to the housing <NUM> described above with respect to <FIG>. For example, the housing <NUM> includes a plurality of channels <NUM> (identified individually as first through fourth channels 252a-d, respectively) that extend between a first side 256a and a second side 256b of the housing <NUM>, a junction structure <NUM> (e.g., an elongated aperture, a bore) that extends laterally across the channels <NUM>, and bracket structures <NUM> (identified individually as a first bracket structure 258a and a second bracket structure 258b) that can releasably secure the housing <NUM> to an inflator device (e.g., an indeflator) and/or other structure associated with a delivery system. In the embodiment illustrated in <FIG>, the channels <NUM> are arranged as two subsets forming two rows of channels <NUM>: a first subset of channels <NUM> including the first and second channels 252a and 252b and a second subset of channels <NUM> including the third and fourth channels 252c and 252d. As described in further detail below with reference to <FIG>, the channels <NUM> in each subset are arranged in parallel with each other, but not necessarily in parallel with the channels <NUM> of the other subset. For example, the first subset of channels <NUM> may extend diagonally upward from the first side 256a to the second side 256b of the housing <NUM>, and the second subset of channels <NUM> may extend diagonally downward from the first side 256a to the second side 256b, or vice versa. The housing <NUM> can integrate various components to collectively form a fluid diversion device operable to control fluid flow in a delivery system (e.g., the delivery system <NUM> of <FIG>) to deploy or recapture a prosthetic heart valve device.

As shown in <FIG>, the housing <NUM> may further include a plurality of guide rails <NUM> (identified individually as first and second guide rails 261a and 261b, respectively) that terminate at one or more grooves or notches <NUM> (identified individually as first through third notches 260a-c, respectively). The notches <NUM> are configured to support a portion of a handle actuator (not shown) of a fluid diversion device at a plurality of rotationally offset positions (e.g., two or three different positions), and each position rotationally offset position defined by the notches <NUM> can correspond to a different mode of the fluid diversion device (e.g., a deployment mode, a recapture mode, and a neutral mode). For example, placing the handle actuator on the first notch 260a can set the fluid diversion device to a recapture configuration, placing the handle actuator on the second notch 260b can set the fluid diversion device to a neutral configuration, and placing the handle actuator on the third notch 260c can set the fluid diversion device to a deploy configuration.

<FIG> is an isomeric view of a fluid diversion device <NUM> including the housing <NUM> of <FIG> configured in accordance with embodiments of the present technology, and <FIG> is a partially transparent isometric view illustrating internal features of the fluid diversion device of <FIG>. The fluid diversion device <NUM> can include various features generally similar to the features of the fluid diversion device <NUM> described above with respect to <FIG>. For example, the fluid diversion device <NUM> includes a plurality of fluid lines or tubes <NUM> (identified individually as firs through fourth tubes 270a-d, respectively) received in corresponding channels <NUM>, a flow control component <NUM> extending through the junction structure <NUM> (<FIG>), and a handle actuator <NUM> coupled to the flow control component <NUM>. The tubes <NUM> can include or be coupled to fittings (e.g., the fittings <NUM> of <FIG>) that form inlets and/or outlets of the fluid diversion device <NUM> to deliver fluid to/from deploy and recapture chambers of a delivery catheter (e.g., the delivery catheter device of FIGS.

In operation, the fluid diversion device <NUM> can alternatively occlude fluid flow through a subset of the tubes <NUM>, while allowing fluid flow through another subset of the tubes <NUM> by rotating the flow control component <NUM> in a manner similar to the fluid diversion device <NUM> described above with respect to <FIG>. For example, the handle actuator <NUM> can be rotated between at least two positions to change the direction of fluid flow relative to two chambers of the delivery catheter coupled to the fluid diversion device <NUM>. However, unlike the fluid diversion device <NUM> of <FIG> that includes a plurality of cams that selectively act on subsets of tubes <NUM> arranged in parallel, the fluid control component <NUM> of the fluid diversion device <NUM> shown in <FIG> includes a single cam that acts on tubes arranged on opposite sides of the cam <NUM>. The cam <NUM> (<FIG>) can close and open subsets of the tubes <NUM> by rotating the flow control component <NUM> to first and second positions. For example, moving the handle actuator <NUM> to the third notch 260c causes the flow control component <NUM> to rotate to the first position. In this first position, the flow control component <NUM> occludes fluid flow through the first and second tubes 270a and 270b, while allowing fluid flow through the third and fourth tubes 270c and 270d. Moving the handle actuator <NUM> to the first notch 260a causes the flow control component <NUM> to the second position in which the cam <NUM> occludes fluid flow through third and fourth tubes 270c and 270d and allows fluid flow through the first and second tubes 270a and 270b. Hence, the fluid diversion device <NUM> can be switched between a first configuration (e.g., a deploy configuration) and a second configuration (e.g., a recapture configuration) by rotating the fluid control component <NUM> to the first or second positions, respectively.

<FIG> are partially transparent isomeric, back, and side views, respectively, of the fluid diversion device <NUM> of <FIG> in a first state or configuration (e.g., a deploy configuration), and <FIG> are partially transparent isomeric, back, and side views, respectively, of the fluid diversion device <NUM> of <FIG> in a second state or configuration (e.g., a recapture configuration). When the fluid diversion device <NUM> is in the first state shown in <FIG>, the fluid control component <NUM> is in the first position such that the first and second channels 252a and 252b (i.e., the first subset of channels <NUM>) are occluded by the cam <NUM> to prevent fluid flow through the first and second tubes 270a and 270b, while the third and fourth channels 252c and 252d are open to allow fluid flow through the third and fourth tubes 270c and 270d. The third and fourth tubes 270c and 270d can define a fluid pathway between a fluid reservoir (e.g., an indeflator) and the deploy chamber and a second fluid pathway between the resheathe chamber and a fluid drain. Thus, when the fluid control component <NUM> is in the first position, fluid can be delivered to the deploy chamber via the third or fourth tube 270c,d and channel 252c,d, while fluid simultaneously drains from the resheathe chamber through the other of the tubes 270c,d and channels 252c,d. As shown in <FIG>, the cam <NUM> can also include structures, such as protrusions, to align the tubes <NUM> with the channels <NUM> and separate the tubes <NUM> from each other.

To change the fluid diversion device <NUM> to the second state shown in <FIG>, the user can rotate the handle actuator <NUM> a predetermined amount (e.g., <NUM>-degrees) such that the handle actuator <NUM> is supported by the first notch 260a. This rotation of the handle actuator <NUM> rotates the fluid control component <NUM> to the second position in which the cam <NUM> opens the first and second channels 252a and 252b to allow fluid flow through the first and second tubes 270a and 270b, while occluding the channels third and fourth 252c and 252d to prevent fluid flow through the third and fourth channels 270c and 270d. The first and second tubes 270a and 270b can form a fluid pathway between a fluid reservoir (e.g., an indeflator) and the resheathe chamber and a second fluid pathway between the deploy chamber and a fluid drain. Thus, when the fluid control component <NUM> is in the second position, fluid can be delivered to the resheathe chamber via the first or second tube 270a,b and channel 252a,b, while fluid simultaneously drains from the deploy chamber through the other of the tubes 270a,b and channels 252a,b. Accordingly, the clinician can change the position of the fluid control component <NUM> by rotating the handle actuator <NUM> to form a combination of the different fluid pathways through the tubes <NUM> based on the rotational position of the fluid control component <NUM>.

The fluid diversion device <NUM> can optionally include one or more additional or other configurations, beyond the deploy and recapture configurations. For example, <FIG> is a partially transparent back view of the fluid diversion device <NUM> of <FIG> in a third state or configuration in accordance with embodiments of the present technology. The third configuration may be a neutral configuration in which the flow control component <NUM> is rotated a predetermined degree of rotation (e.g., <NUM>-degrees counter-clockwise) from the deploy configuration. For example, a portion of the handle actuator <NUM> can rest against the second notch 260b to position the flow control component <NUM> in a third position corresponding to the neutral configuration of the device <NUM>. In this neutral mode, the cam <NUM> can partially compress all of the tubes <NUM> to allow all of the tubes <NUM> to be flushed (e.g., before a delivery procedure). In some embodiments, the arrangement of the guide rails <NUM> and/or other features of the fluid diversion device <NUM> prevent the flow control component <NUM> from returning to this neutral configuration during operation once the device <NUM> has been moved from this configuration to avoid this configuration during device delivery.

<FIG> is a partially transparent back view of the fluid diversion device <NUM> of <FIG> in a fourth state or configuration in accordance with embodiments of the present technology. The fourth configuration may be used as a switchover mode in which the flow control component <NUM> is rotated a predetermined degree of rotation (e.g., <NUM>-degrees clockwise) from the first state (e.g., deploy mode) toward the second state (e.g., recapture mode). During switchover, all of the tubes <NUM> may be compressed, which results in a reduced pressure drop when changing between the deployment and recovery configurations.

Although described in terms of configurations with inlets and outlets of the fluid diversion device to pass fluid in certain directions depending on the position of the flow control component, a person skilled in the art would understand that this is a relative arrangement that could be achieved with other arrangements of interconnections. For example, the description of the relative fluid flow can be changed by swapping 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 is in the first position. Moreover, although shown with four tubes disposed in four channels, other embodiments could include additional or fewer tubes or channels arranged in other orientations.

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 fluid 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 fluid diversion device for controlling fluid flow in a delivery system to deploy a prosthetic heart valve device, the fluid diversion device comprising:
a housing including a first side, a second side, a junction structure (<NUM>, <NUM>, <NUM>), and a plurality of channels (<NUM>, <NUM>) traversing the housing from the first side through the junction structure to the second side, and wherein the junction structure extends laterally across the plurality of channels;
an occlusion member disposed in the junction structure, wherein rotation of the occlusion member enables selective occlusion of either a first subset of channels (252a, 252b) of the plurality of channels or a second subset of channels (252c, 252d) of the plurality of channels; and
an actuator operably coupled to the occlusion member to enable selective positioning of the occlusion member in at least a first position that occludes the first subset of channels and a second position that occludes the second subset of channels for fluid communication in different directions relative to a first chamber and a second chamber of a delivery device.