Hydraulic delivery system with a flow diversion device and related methods

Abstract

A shunt device configured in accordance with an embodiment of the present technology may include, for example, a housing including an opening to channels that intersect at a junction. The shunt device may also include, for example, a flow control assembly that is positioned at the junction and is movable to selectively form a path for fluid communication based on the position of the flow control assembly. For example, when the flow control assembly is in a first position, a first path may allow fluid to flow, thereby causing the artificial heart valve device to expand, and when the flow control assembly is in a second position, a second path may allow fluid to flow, thereby causing the artificial heart valve device to retract. The shunt device may include a handle that is movable to position the flow control assembly in the first position or the second position, thereby selectively controlling the fluid flow of the delivery system.

Description

[0001] This application claims the benefit of U.S. Provisional Patent Application No. 62 / 807,681, filed February 19, 2019, which is incorporated herein by reference in its entirety. Technical Field

[0002] The present technology generally relates to devices and systems for delivering medical devices into a patient's body. In particular, several embodiments of the present technology relate to hydraulic delivery systems with shunt devices for deploying prosthetic heart valve devices and related methods. Background Art

[0003] Heart valves can be affected by a variety of conditions. For example, the mitral valve can be affected by mitral regurgitation, mitral valve prolapse, and mitral stenosis. Mitral regurgitation is the abnormal leakage of blood from the left ventricle into the left atrium caused by a cardiac condition in which the leaflets of the mitral valve fail to coapt at peak systolic pressure. The mitral valve leaflets may not coapt adequately due to heart disease, which typically causes dilation of the myocardium, which in turn widens the native mitral annulus to the point where the leaflets will not coapt during systole. Abnormal regurgitation may also occur when the papillary muscles are impaired due to ischemia or other conditions. More specifically, because the left ventricle contracts during systole, the affected papillary muscles do not contract sufficiently to achieve proper closure of the leaflets.

[0004] Mitral valve prolapse is a condition in which the mitral valve leaflets bulge abnormally upward into the left atrium. This can cause irregular behavior of the mitral valve and lead to mitral regurgitation. The leaflets may prolapse and fail to coapt because the tendons (chordae tendineae) that connect the papillary muscles to the underside of the mitral valve leaflets may tear or stretch. Mitral stenosis is a narrowing of the mitral valve orifice that prevents filling of the left ventricle during diastole.

[0005] Mitral regurgitation is typically treated with diuretics and / or vasodilators to reduce the amount of blood flowing back into the left atrium. Surgical approaches (e.g., open and endovascular) for repairing or replacing the valve have also been used to treat mitral regurgitation. For example, a typical repair technique involves reducing or resecting a portion of the dilated annulus. Reduction, for example, involves implanting an annular or nearly annular ring that is typically secured to the annulus or surrounding tissue. Other repair procedures sew or clamp the valve leaflets into apposition to one another.

[0006] Alternatively, more invasive procedures replace the entire valve itself by implanting a mechanical valve or biological tissue into the heart to replace the native mitral valve. These invasive procedures typically require a large degree of open-heart surgery and are therefore very painful, have high morbidity rates, and require a long recovery period. In addition, in many repair and replacement procedures, the durability of the device or the improper size of the annuloplasty ring or replacement valve may cause additional problems for the patient. Repair surgery also requires a highly skilled cardiac surgeon because improper or inaccurate placement of sutures may affect the success of the operation.

[0007] In recent years, less invasive aortic valve replacement methods have been implemented. Examples of pre-assembled percutaneous prosthetic valves include, for example, the CoreValve from Medtronic / Corevalve Inc. (Irvine, CA, USA). system and from Edwards Lifesciences (Irvine, CA, USA) Valves. Both valve systems include an expandable frame and a tri-leaflet bioprosthetic valve attached to the expandable frame. The aortic valve is substantially symmetrical, circular, and has a muscular annulus. The expandable frame in aortic applications has a symmetrical circular shape at the aortic valve annulus to match the native anatomy, and because the tri-leaflet prosthetic valve requires circular symmetry to achieve proper engagement of the prosthetic leaflets. Therefore, the aortic valve anatomy is suitable for accommodating an expandable frame for a replacement valve because the aortic valve anatomy is substantially uniform, symmetrical, and fairly robust. However, other heart valve anatomy is not uniform, asymmetrical, or not robust enough, and therefore, transvascular aortic valve replacement devices may not be well suited for other types of heart valves.

[0008] Therefore, during mitral valve replacement surgery, timely and targeted implant deployment is critical and challenging due to the complex anatomy of the heart. Therefore, it is desirable to have a delivery system that can implement complex manipulations in a flexible manner to facilitate targeted delivery of the implant with minimal time and procedural steps by alleviating the physical and cognitive burden on the clinician operating the delivery system during replacement surgery. Summary of the Invention

[0009] In some instances, the present disclosure relates to a shunt device for controlling the flow of fluid in a delivery system to deploy an artificial heart valve device. The shunt device includes a housing comprising a plurality of channels intersecting at a joint and a plurality of openings of the plurality of channels in fluid communication with the joint, wherein the plurality of openings include a first opening and a second opening. The shunt device further includes a flow control assembly disposed at the joint and movable to selectively form a plurality of paths based on the position of the flow control assembly, the plurality of paths including a first path and a second path for fluid communication between the plurality of openings through the plurality of channels, wherein when the flow control assembly is in a first position, the first path is formed to allow fluid to flow at least through the first opening toward a first chamber of the delivery system to cause the artificial heart valve device to deploy, and wherein when the flow control assembly is in a second position, the second path is formed to allow fluid to flow at least through the second opening toward a second chamber of the delivery system to cause the artificial heart valve device to retract. The diversion device further includes a handle that is operably connected to the flow control assembly and is movable to position the flow control assembly in at least either of the first position and the second position to selectively allow fluid to flow toward at least either of the first chamber or the second chamber of the delivery system.

[0010] In some examples, the present disclosure relates to a system for delivering a prosthetic heart valve device to a patient's heart. The system includes: an elongated catheter body containing a delivery control assembly that is hydraulically actuated to deploy and retract the prosthetic heart valve device relative to the patient's heart; a flow shunt device comprising a housing containing a plurality of openings comprising a plurality of channels intersecting at a junction; and a flow control assembly positioned at the junction and movable to selectively form a plurality of pathways for fluid communication between the plurality of openings through the plurality of channels based on a position of the flow control assembly, wherein when the flow control assembly is in a first position, a first pathway is formed to allow fluid to flow through a first opening of the plurality of openings to deploy the prosthetic heart valve device into the patient's heart by filling a first chamber of the system, and wherein when the flow control assembly is in a second position, a second pathway is formed to allow fluid to flow through a second opening of the plurality of openings to retract the prosthetic heart valve device from the patient's heart by exhausting the first chamber of the system. The system further includes a handle movable to change the position of the flow control assembly between the first position and the second position to select from the plurality of paths for fluid communication with the first chamber.

[0011] In some examples, the present disclosure relates to a flow shunt device that controls fluid flow in a system configured to implant a medical device in a patient. The flow shunt device includes a housing comprising a plurality of openings comprising a plurality of channels intersecting at a junction; a flow control assembly 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 assembly, wherein when the flow control assembly is in a first position, a first pathway is formed to allow fluid to flow through a first opening of the plurality of openings toward a first chamber of the delivery control assembly to cause deployment of the medical device; and wherein when the flow control assembly is in a second position, a second pathway is formed to allow fluid to flow through a second opening of the plurality of openings toward a second chamber to cause retraction of the medical device; and a handle operably coupled to the flow control assembly and movable to change the position of the flow control assembly between at least the first and second positions to selectively form any one of the plurality of pathways for fluid communication with at least the first and second chambers of the delivery control assembly. BRIEF DESCRIPTION OF THE DRAWINGS

[0012] Many aspects of the present disclosure may be better understood with reference to the following drawings. The components in the drawings are not necessarily to scale. Instead, emphasis is placed on clearly illustrating the principles of the present disclosure. Furthermore, components may be shown as transparent in certain views for illustrative purposes only, without indicating that the components shown must be transparent. The headings provided herein are for convenience only.

[0013] Figure 1 is a schematic cross-sectional illustration of a heart illustrating an antegrade approach from the venous vasculature to the native mitral valve in accordance with various embodiments of the present technology.

[0014] Figure 2 is a schematic cross-sectional illustration of a heart showing passage through the atrial septum (IAS) maintained by placement of a guide catheter over a guidewire in accordance with various embodiments of the present technology.

[0015] Figure 3 is a schematic cross-sectional illustration of a heart illustrating aspects of a retrograde approach through the aortic valve and arterial vasculature to the native mitral valve in accordance with various embodiments of the present technology.

[0016] Figure 4 is a schematic cross-sectional illustration of a heart illustrating another aspect of a retrograde approach through the aortic valve and arterial vasculature to the native mitral valve in accordance with various embodiments of the present technology.

[0017] Figure 5 is a schematic cross-sectional illustration of a heart illustrating access to the native mitral valve using a transapical puncture in accordance with various embodiments of the present technology.

[0018] Figure 6 is an isometric view of a delivery system for delivering a prosthetic heart valve device configured in accordance with an embodiment of the present technology.

[0019] Figure 7A is in a housing configuration according to an embodiment of the present technology Figure 6 Partial cross-sectional view of the delivery system.

[0020] Figure 7B is in an expanded configuration according to an embodiment of the present technology Figure 6 Partial cross-sectional view of the delivery system.

[0021] Figure 8A is a top view of a diversion device configured in accordance with an embodiment of the present technology.

[0022] Figure 8B yes Figure 8A Bottom view of the diversion device.

[0023] Figure 9A is in a first configuration according to an embodiment of the present technology Figure 8A and 8B A partial cross-sectional view of the diversion device.

[0024] Figure 9B is in a second configuration according to an embodiment of the present technology Figure 8A and 8B A partial cross-sectional view of the diversion device.

[0025] Figure 10A is in a first configuration according to an embodiment of the present technology Figure 8A and 8B Partial schematic functional diagram of the diversion device.

[0026] Figure 10B is in a second configuration according to an embodiment of the present technology Figure 8A and 8B Partial schematic functional diagram of the diversion device.

[0027] Figure 11 is a side view of a flow diverter device connectable to an inflator device according to an embodiment of the present technology.

[0028] Figure 12A is a top view of a shunt device in a first configuration according to an embodiment of the present technology.

[0029] Figure 12B is in a second configuration according to an embodiment of the present technology Figure 12A Top view of the diversion device.

[0030] Figure 12C is in a third configuration according to an embodiment of the present technology Figure 12A and 12B Top view of the diversion device.

[0031] Figure 13 yes Figures 12A-12C A partial exploded view of the diversion device. DETAILED DESCRIPTION

[0032] The present technology generally relates to hydraulic delivery systems having shunt devices for delivering medical devices and related methods. Figure 1-13 Specific details of several embodiments of the present technology are described. Although many embodiments are described with respect to devices, systems and methods for delivering an artificial heart valve device to a native mitral valve, other applications and other embodiments besides the applications and embodiments described herein are also within the scope of the present technology. For example, at least some embodiments of the present technology can be used to deliver prostheses to other valves, such as the tricuspid valve or the aortic valve. It should be noted that in addition to the embodiments disclosed herein, other embodiments are also within the scope of the present technology. In addition, a person of ordinary skill in the art will understand that embodiments of the present technology may have configurations, components and / or processes other than those shown or described herein, and that these and other embodiments may not have several of the configurations, components and / or processes shown or described herein without departing from the present technology.

[0033] With respect to the terms "distal" and "proximal" within this specification, unless otherwise indicated, the terms may refer to the relative position of portions of a prosthetic valve device and / or an associated delivery device with respect to an operator and / or a position in the vasculature or heart. For example, in reference to a delivery catheter suitable for delivering and positioning the various prosthetic valve devices described herein, "proximal" may refer to a position that is closer to the operator of the device or an incision in the vasculature, while "distal" may refer to a position farther from the operator of the device or farther from the incision along the vasculature (e.g., the end of a catheter). With respect to a prosthetic heart valve device, the terms "proximal" and "distal" may refer to the position of portions of the device relative to the direction of blood flow. For example, proximal may refer to an upstream position or a position where blood flows into the device (e.g., an inflow region), while distal may refer to a downstream position or a position where blood flows out of the device (e.g., an outflow region).

[0034] Several embodiments of the present technology relate to delivery systems with flow diversion devices for mitral valve replacement devices that address the unique challenges of percutaneous replacement of a native mitral valve and are well-suited for retraction within a percutaneous delivery device after partial deployment for repositioning or device removal. Percutaneous mitral valve replacement presents unique anatomical obstacles compared to aortic valve replacement, making it significantly more challenging than aortic valve replacement. First, unlike the relatively symmetrical and uniform aortic valve, the mitral valve annulus has a non-circular, D-shaped or kidney-like shape, with a non-planar, saddle-like geometry that often lacks symmetry. The complex and highly variable anatomy of the mitral valve makes it difficult to design a mitral valve prosthesis that is perfectly conformable to a specific patient's native mitral valve annulus. As a result, the prosthesis may not fit well within the native leaflets and / or annulus, potentially leaving gaps through which blood backflow may occur. For example, placement of a cylindrical valve prosthesis within a native mitral valve may leave gaps in the commissure region of the native valve, through which paravalvular leaks may occur.

[0035] Currently developed prosthetic valves for percutaneous aortic valve replacement are unsuitable for use in mitral valves. First, many of these devices require a direct structural connection between a stent-like structure that contacts the annulus and / or leaflets and the prosthetic valve. In many devices, the stent struts supporting the prosthetic valve also contact the annulus or other surrounding tissue. These types of devices transmit the forces exerted by tissue and blood during heart contraction directly to the valve support and prosthetic leaflets, which in turn distort the valve support from its desired cylindrical shape. This is a significant concern because most heart replacement devices use trileaflet valves, which require a substantially symmetrical cylindrical support around the prosthetic valve to ensure the three leaflets open and close properly over their multi-year lifespan. Therefore, when these devices experience motion or forces from the annulus and other surrounding tissues, the prosthesis may compress and / or distort, causing the prosthetic leaflets to malfunction. Furthermore, the diseased mitral valve annulus is much larger than any available aortic valve prosthesis. As valve size increases, the forces on the valve leaflets increase significantly, so simply increasing the size of the aortic prosthesis to the size of the dilated mitral annulus would require significantly thicker, taller leaflets and may not be feasible.

[0036] In addition to having an irregular, complex shape that changes size during each heartbeat, the mitral valve annulus lacks a significant amount of radial support from the surrounding tissue. Compared to the aortic valve, which is completely surrounded by fibroelastic tissue that provides sufficient support to anchor the prosthetic valve, the mitral valve is constrained only by the muscle tissue on the outer wall. The inner wall of the mitral valve anatomy is constrained by the thin vessel wall that separates the mitral valve annulus from the lower portion of the aortic valve outflow tract. Therefore, significant radial forces on the mitral valve annulus (such as those imparted by expanding the stent prosthesis) may cause the lower portion of the aortic tract to collapse. In addition, larger prostheses exert greater forces and expand to larger sizes, which exacerbates this problem in mitral valve replacement applications.

[0037] The chordae tendineae of the left ventricle can also create obstacles when deploying a mitral valve prosthesis. Unlike the aortic valve, the mitral valve has a maze of cordage beneath the leaflets in the left ventricle that restricts movement and position of the deployment catheter and replacement device during implantation. Consequently, deploying, positioning, and anchoring a valve replacement device on the ventricular side of the native mitral annulus is complex.

[0038] 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 the correct position relative to the native annulus, leaflets, left atrium, and left ventricular outflow tract. Therefore, it is desirable to have a delivery system that can flexibly deploy and / or retract the valve replacement device with a minimum of time and procedural steps. However, conventional delivery systems include cumbersome shunt devices, such as an arrangement of multiple interconnected three-way stopcocks that must be individually adjusted to a desired position to change the delivery direction from deployment to retraction (or vice versa). This arrangement can be confusing and require excessive additional time, making the use of conventional shunt devices a physical and cognitive burden on the clinician and increasing the risks associated with the replacement procedure.

[0039] Embodiments of the present technology provide systems, methods, and apparatus for treating a heart valve of the body, such as the mitral valve, that address challenges associated with the anatomy of the mitral valve and provide for repositioning and removal of valve replacement devices. The disclosed embodiments include shunt devices that can perform complex maneuvers to flexibly place the valve replacement device in a targeted location in a timely manner by alleviating the physical and cognitive burden of operating the shunt device on the clinician.

[0040] The disclosed embodiments overcome the aforementioned shortcomings by utilizing a dual hydraulic delivery system shunt device that can easily and reliably deploy and / or retract a valve replacement device. For example, the shunt device of the disclosed embodiments can implement a switching mechanism that requires only a single action to switch between the deployed and retracted configurations. Thus, the disclosed embodiments eliminate the need for multiple interconnected three-way stopcocks, which saves clinicians time by simplifying the operations used to change the delivery device from the deployed configuration to the retracted configuration (and vice versa).

[0041] The disclosed systems and methods achieve percutaneous access using a catheter delivered intravascularly through a vein or artery into the heart or by insertion of a cannula through the heart wall. For example, the systems and methods are particularly well suited for transseptal and transapical approaches, and can also be transatrial and direct aortic delivery of a prosthetic valve replacement to a target location in the heart. Furthermore, embodiments of the systems and methods described herein can be combined with many known surgical procedures and procedures, such as known methods of approaching a valve of the heart (e.g., the mitral or tricuspid valve) by antegrade or retrograde approaches, and combinations thereof.

[0042] The disclosed shunt device facilitates the controlled delivery of an artificial heart valve device using a transapical or transseptal delivery approach and allows the artificial heart valve device to be re-sheathed after the device is partially deployed to reposition and / or remove the device. The disclosed shunt device is connected to two fluid chambers that can be interchangeably filled with fluid and drained to initiate the deployment and re-sheathing of the prosthetic device. This facilitates hydraulic control and power of the proximal and distal movements of the delivery capsule shell that provides controlled delivery of the artificial heart valve device and suppresses uncontrolled movement of the delivery system (e.g., axial runout, self-ejection) due to forces associated with the expansion of the artificial heart valve device. Compared to a mechanical delivery system that suffers from frictional losses due to a mechanical connection between the distal and proximal ends, the disclosed hydraulic delivery system transmits force more efficiently. In addition, the disclosed hydraulic delivery system can suppress longitudinal translation of the artificial heart valve device relative to the treatment site when the artificial heart valve device moves between a contained configuration (i.e., fully retracted) and a deployed configuration. This enables the clinician to accurately position a sheathed prosthetic heart valve device at a desired target site for deployment, and then deploy the device at the target site without having to compensate for any axial movement caused by deployment.

[0043] To better understand the structure and operation of the valve replacement device according to the present technology, it is helpful to first understand the access route for implanting the device. The mitral valve or other types of atrioventricular valves can be accessed percutaneously through the patient's vasculature. Percutaneous means accessing the vasculature remote from the heart through the skin, typically using surgical incision or minimally invasive surgery (such as using a needle approach using, for example, the Seldinger technique). The ability to access distal vasculature percutaneously is well known and described in patents and medical literature. Depending on the vascular access point, access to the mitral valve can be antegrade and can rely on entering the left atrium through the atrial septum (e.g., a transseptal 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 can also be achieved through a transapical approach using a cannula. As described herein, depending on the approach, the interventional tool and one or more support catheters can be advanced intravascularly to the heart and positioned adjacent to the target heart valve in various ways.

[0044] Figure 1 A stage of a transseptal approach for implanting a valve replacement device is shown. In a transseptal approach, the passage is through the inferior vena cava IVC or superior vena cava SVC, through the right atrium RA, across the atrial septum IAS and into the left atrium LA above the mitral valve MV. Figure 1 As shown, a catheter 1 with a needle 2 is moved from the inferior vena cava IVC into the right atrium RA. Once the catheter 1 reaches the anterior side of the atrial septum IAS, the needle 2 is advanced so that it penetrates the septum, for example at the fossa ovalis FO or foramen ovale, and enters the left atrium LA. At this point, the guidewire replaces the needle 2 and the catheter 1 is withdrawn.

[0045] Figure 2 A subsequent stage of the transseptal approach is shown in which the guidewire 6 and guide catheter 4 are passed through the atrial septum IAS. The guide catheter 4 provides access to the mitral valve for implantation of a valve replacement device according to the present technology.

[0046] In an alternative antegrade approach (not shown), surgical access can be gained through an intercostal incision (preferably without removing a rib), and a small puncture or incision can be made in the left atrial wall. A guiding catheter is passed through this puncture or incision directly into the left atrium, which is sealed with a purse string suture.

[0047] As described above, an antegrade or transseptal approach to the mitral valve is advantageous in many respects. For example, an antegrade approach will generally allow for more precise and effective centering and stabilization of the guide catheter and / or prosthetic valve device. An antegrade approach may also reduce the risk of damage to the chordae tendineae or other subvalvular structures by the catheter or other interventional instrument. In addition, an antegrade approach may reduce the risks associated with traversing the aortic valve in a retrograde approach. This may be particularly relevant to patients with prosthetic aortic valves, where traversal of the prosthetic aortic valve is not possible at all or without substantial risk of damage.

[0048] Figure 3 and 4 An example of a retrograde approach to the mitral valve is shown. Access to the mitral valve MV can 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 can be accessed via a conventional femoral approach or via a more direct approach via the brachial, axillary, radial or carotid arteries. Such access can be achieved using a guide wire 6. Once in place, a guide catheter 4 can be tracked over the guide wire 6. Alternatively, surgical access can be obtained by making an incision in the chest (preferably between the ribs without removing the ribs) and placing a guide catheter through a puncture in the aorta itself. The guide catheter 4 provides subsequent access to allow placement of an artificial valve device, as described in more detail herein. Advantageously, the retrograde approach does not require a transseptal puncture. The retrograde approach is also more commonly used by cardiologists and is therefore more well known.

[0049] Figure 5 A transapical approach via a transapical puncture is shown. In this approach, access to the heart is achieved through a chest incision (which can be a conventional thoracotomy or sternotomy) or a smaller intercostal or subxiphoid incision or puncture. An access cannula is then placed at or near the apex of the heart through a puncture in the left ventricular wall. The catheter and prosthetic device of the present disclosure can 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 the transapical approach does not involve intravascular access, it does not require interventional cardiology training to perform the catheterization required in other percutaneous approaches.

[0050] During transcatheter heart valve replacement (e.g., delivered via a transfemoral or transapical approach), it is crucial to deploy the prosthetic heart valve device to a target position relative to the native annulus, leaflets, left atrium, and left ventricular outflow tract (LVOT) in a controlled and efficient manner. For example, a delivery system can hydraulically control the motion of a delivery capsule to reduce, limit, or substantially eliminate uncontrolled deployment (also known as "jumping") of the prosthetic heart valve device caused by the forces associated with expanding the heart valve device. The delivery system can also use hydraulically controlled motion to re-sheath a partially or fully expanded heart valve device to allow the heart valve device to be repositioned relative to the natural anatomy and / or to retract the device for removal from the body.

[0051] The hydraulic delivery system described herein includes a diverter device that facilitates the change between the deployed configuration and the retracted configuration to provide bidirectional motion of the delivery assembly. For example, the disclosed diverter device does not include multiple independent stopcocks that need to be individually manipulated to change the direction of motion of the delivery capsule. Instead, the disclosed diverter device has a single actuator that can be manipulated to direct fluid in at least two different directions and thus provide a reversal of the direction of the delivery capsule. In some embodiments, the diverter device has a handle that can be switched between two positions to move the delivery capsule in opposite directions and thereby cause the deployment or retraction of the artificial heart valve device. Therefore, the disclosed diverter device simplifies the process for performing complex operations to switch between the deployed configuration and the retracted configuration, and enhances the efficiency and ease of use of the delivery process.

[0052] Figure 61 is an isometric view of a hydraulic delivery system 100 ("system 100") for delivering a prosthetic heart valve device configured according to an embodiment of the present technology. System 100 includes a catheter 102 having an elongated catheter body 108 and a delivery capsule 106. The catheter body 108 can include a proximal portion 108a coupled to a handheld control unit 104 and a distal portion 108b carrying the delivery capsule 106. The delivery capsule 106 can be configured to accommodate a prosthetic heart valve device 110 (schematically shown in dashed lines). The control unit 104 can provide steering capabilities (e.g., 360-degree rotation of the delivery capsule 106, 180-degree rotation of the delivery capsule 106, 3-axis steering, 2-axis steering) for delivering the delivery capsule 106 to a target site (e.g., to a native mitral valve) and deploying the prosthetic heart valve device 110 at the target site. The catheter 102 can be configured to travel over a guidewire 120, which can be used to guide the delivery capsule 106 into the native heart valve. System 100 also includes a shunt device 112 configured to supply a flowable substance (ie, hydraulic fluid, such as water or saline) to catheter 102 and receive fluid through catheter 102 to hydraulically move delivery capsule 106 and deploy prosthetic heart valve device 110 .

[0053] The control unit 104 may include a control assembly 122 and a steering mechanism 124. For example, the control assembly 122 may include a rotational element (e.g., a handle) that can be rotated to rotate the delivery capsule 106 about its longitudinal axis 107. The control assembly 122 may also include features that allow a clinician to control the hydraulic deployment mechanism of the delivery capsule 106 and / or the shunt device 112. For example, the control assembly 122 may include a button, a lever, and / or other actuator that initiates unsheathing and / or resheathing of the prosthetic heart valve device 110. The steering mechanism 124 may be used to steer the catheter 102 through the anatomical structure by bending the distal portion 108b of the catheter body 108 about the transverse axis. In other embodiments, the control unit 104 may include additional and / or different features that facilitate delivery of the prosthetic heart valve device 110 to the target site.

[0054] The delivery capsule 106 includes a housing 126 configured to accommodate and carry the artificial heart valve device 110 and, optionally, an end cap 128 extending from an end of the housing 126 and enclosing the artificial heart valve device 110 within the housing 126. The delivery capsule 106 may have an opening 130 at its distal end through which the guidewire 120 may pass to allow the guidewire to be delivered to the target site. Figure 6As shown, the distal portion of the delivery capsule 106 can also have an atraumatic shape (e.g., a partial sphere, a frustoconical shape, a blunt configuration, a rounded configuration) to facilitate atraumatic delivery of the delivery capsule 106 to the target site. The housing 126, the end cap 128, and / or other portions of the delivery capsule 106 can be made of metal, a polymer, a plastic, a composite material, a combination thereof, or other materials capable of retaining the prosthetic heart valve device 110.

[0055] As discussed in further detail below, the delivery capsule 106 is hydraulically driven by the control unit 104 and / or the shunt device 112 between a containment configuration or state for maintaining the artificial heart valve device 110 within the delivery capsule 106 and a deployment configuration or state for at least partially deploying the artificial heart valve device 110 from the delivery capsule 106 at a target site. The control unit and / or the shunt device 112 also allow the artificial heart valve device 110 to be re-sheathed (e.g., retracted) after it has been partially deployed. For example, the delivery capsule 106 can be hydraulically driven from the containment configuration to the deployment configuration by supplying a flowable liquid to a chamber of the delivery capsule 106 while optionally also removing the flowable liquid from a separate chamber of the delivery capsule 106. The hydraulically controlled movement of the delivery capsule 106 is expected to reduce, limit, or substantially eliminate uncontrolled deployment of the artificial heart valve device 110, such as jumping, self-ejection, and / or other types of uncontrolled movement, caused by the forces associated with the expansion of the artificial heart valve device 110. For example, when at least a portion of the prosthetic heart valve device 110 is expanded, it is contemplated that the delivery capsule 106 inhibits or prevents translation of the prosthetic heart valve device 110 relative to the catheter body 108. After partial deployment from the delivery capsule 106, the delivery capsule 106 can be hydraulically driven back to a contained configuration (e.g., retracting the device 110) by transferring fluid into one chamber of the delivery capsule 106 and, optionally, removing fluid from another chamber of the delivery capsule 106 in a manner opposite to that used for deployment. The re-sheathing (also referred to herein as retraction) capability enables a clinician to reposition the prosthetic heart valve device 110 in vivo for re-deployment within the mitral valve MV, or to remove the prosthetic heart valve device 110 from the patient's body after partial deployment. After the prosthetic heart valve device 110 is fully deployed, the end cap 128 can be pulled through the deployed prosthetic heart valve device 110 to close the delivery capsule 106 again, and the catheter 102 can be pulled proximally through the guide catheter for removal from the patient's body. After removal of the catheter 102, it can be sterilized and used to deliver another prosthetic device, or it can be discarded.

[0056] like Figure 6As further shown in Figure 1, diverter 112 is coupled to conduit 102 via one or more fluid lines 116. Diverter 112 is also coupled to one or more reservoirs 114 (identified separately as first reservoir 114a and second reservoir 114b) that can hold flowable substances (e.g., water, saline) to hydraulically drive the movement of delivery capsule 106. Each reservoir in reservoir 114 can include one or more fluid sources, such as an inflator device with pressurized fluid and / or a discharge port configured to accommodate discharged fluid. Diverter 112 and / or fluid reservoir 114 can also include one or more hoses, tubes, or other components (e.g., fittings, connectors, valves, pumps) that can transfer fluid from one or more reservoirs 114 to conduit 102 and / or can discharge fluid from conduit 102 to one or more reservoirs 114. During use, diverter device 112 may be manipulated to move fluid from one or more of reservoirs 114 to conduit 102 via one or more fluid lines 116 and / or drain fluid from conduit 102 to one or more of reservoirs 114 via one or more fluid lines 116 .

[0057] like Figure 6 As further shown in the illustrated embodiment, the flow diverter device 112 includes a housing 180 that at least partially encloses a flow control mechanism for controlling the flow of fluid into and out of the conduit 102 and the reservoir 114. The flow control mechanism can include a mechanical element, such as a cylindrical member received by an elongated orifice (e.g., a hole) in the housing 180 and movable longitudinally relative to the hole to switch the direction of fluid flow through a passage formed, in part, by an arrangement of sealed compartments within the housing 180. In some embodiments, the flow control mechanism includes a lever and / or other actuator for controlling the deployment or resheathing of the prosthetic heart valve device 110. For example, the flow control mechanism can include a rotational element, such as a handle 118, that can be rotated or otherwise manipulated to move the cylinder longitudinally and thereby change the direction of fluid flow along the fluid line 116.

[0058] In some embodiments, the shunt device 112 and / or other parts of the system 100 are connected to a controller (not shown), which may include but is not limited to 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 may 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 may include pumping programs, patient information and / or other executable programs. The controller may further include a manual input device (e.g., a keyboard, a touch screen) and / or an automatic input device (e.g., a computer, a data storage device, a server, a network). In other embodiments, the controller may include different features and / or have different arrangements to control the flow of fluid flowing into and out of the reservoir 114. In still other embodiments, one or more components or at least a portion of the shunt device 112 are integrated into the handle of the system 100.

[0059] Figure 7A and 7B is in a housing configuration according to an embodiment of the technology of the present invention ( Figure 7A ) and expanded configuration ( Figure 7B )of Figure 6 A partial cross-sectional view of a delivery system 100. Figure 7A and 7B As shown, the distal portion 108b of the elongated catheter body 108 carries the delivery capsule 106. The delivery capsule 106 includes a housing 126 and a platform 142, which together at least partially define a first chamber 144a and a second chamber 144b (collectively, "chambers 144"). The first chamber 144a and the second chamber 144b are fluid-tightly sealed from each other and from a compartment 146 in the housing 126 that is configured to house at least a portion of the prosthetic heart valve device 110. The chamber 144 can be filled and emptied to adjust the chamber 144 to a desired position in a contained configuration (eg, a position in which the prosthetic heart valve device 110 is held). Figure 7A ) and a deployed configuration for at least partially deploying the prosthetic heart valve device 110 ( Figure 7B ) between the hydraulic drive delivery capsule 106. In some embodiments, one or both of the chambers 144 are housed between the catheter body 108, the control unit 104 ( Figure 6 ), a different handle and / or another part of the system 100.

[0060] like Figure 7AAs shown, as fluid is at least partially expelled from the first chamber 144a (as indicated by arrow 159) while fluid is delivered to the second chamber 144b (as indicated by arrow 157), the housing 126 of the delivery capsule 106 is proximally (in the direction of arrow 153) urged toward the deployed configuration. The proximal translation of the housing 126 enables the prosthetic heart valve device 110 to at least partially deploy and expand from the housing 126 so that it can engage the surrounding tissue of the native mitral valve. Figure 7B As shown, when fluid is at least partially expelled from the second chamber 144b (as indicated by arrow 161) while fluid is delivered to the first chamber 144a (as indicated by arrow 163), the housing 126 is pushed distally back to the containing configuration to re-sheath at least a portion of the artificial heart valve device 110.

[0061] The platform 142 extends at least partially between the inner walls of the housing 126 to divide the housing 126 into a first chamber 144a and a second chamber 144b. The platform 142 can be integrally formed as part of the housing 126, such as an inwardly extending flange. Thus, the platform 142 can be made of the same material as the housing 126 (e.g., metal, polymer, plastic, composite material, or combinations thereof). In other embodiments, the platform 142 can be a separate component that at least partially separates the two chambers 144 from each other.

[0062] like Figure 7A and 7B As shown, a fluid delivery shaft 148 extends through the catheter body 108, into the housing 126 of the delivery capsule 106, and through the platform 142. The shaft 148 is coupled to the diverter device 112 at a proximal end (not shown) and contains one or more fluid lines 152 (individually identified as a first line 152a and a second line 152b) that can deliver fluid to and / or remove fluid from the chamber 144. The fluid lines 152 can be fluid passages or lumens integrally formed within the shaft 148, such as channels through the shaft itself, or the fluid lines 152 can be tubes or hoses positioned within one or more hollow regions of the shaft 148. 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 chamber 144a and the second chamber 144b can be in fluid communication with more than one fluid line. For example, each chamber 144 can have a dedicated fluid delivery line and a dedicated fluid exhaust line.

[0063] The shaft 148 may also include a first flange or base 154a and a second flange or base 154b (collectively referred to as "flanges 154") extending outwardly from the shaft 148 to define the proximal and distal ends of the first and second chambers 144a, 144b, respectively. Thus, the first chamber 144a is defined at the distal end by the proximal-facing surface of the platform 142, at the proximal end by the distal-facing surface of the first flange 154a, and by the inner wall of the housing 126 extending therebetween. The second chamber 144b is defined at the proximal end by the distal-facing surface of the platform 142, at the distal end by the proximal-facing surface of the second flange 154b, and by the inner wall of the housing 126 extending therebetween. The compartment 146 containing the prosthetic heart valve device 110 may be defined by the distal-facing surface of the second flange 154b, the distal end of the housing 126, and the inner wall of the housing 126 extending therebetween. The shaft 148 and flange 154 can be integrally formed or separate components and can be made of metal, polymer, plastic, composite material, combinations thereof, and / or other suitable materials for containing fluids. The flange 154 is fixed relative to the shaft 148. A sealing member 156 (independently referred to as a first sealing member to a third sealing member 156a-c) such as an O-ring can be positioned around or within the flange 154 and / or platform 142 to fluidically seal the chamber 144 from the rest of the delivery capsule 106. For example, the first sealing member 156a and the second sealing member 156b can be positioned in the corresponding recesses of the first flange 154a and the second flange 154b to fluidically seal the flange 154 to the inner wall of the housing 126, and the third sealing member 156c can be positioned in the recess of the platform 142 to fluidically seal the platform 142 to the shaft 148. In other embodiments, the system 100 can include additional and / or differently arranged sealing members to fluidically seal the chamber 144.

[0064] Fluid line 152 is in fluid communication with diversion device 112 at a proximal portion of system 100 (e.g., via Figure 6 The flow diverter 112 includes a housing 180 that encloses or defines an arrangement of interconnected channels 212 (examples of which are shown in FIG. 1 ) that intersect at a junction structure 184 (e.g., a tubular structure or orifice). Figure 9A and 9B 180). The engagement structure 184 and the passage 212 are in fluid communication with an orifice or opening 203 located on or accessible from the exterior of the housing 180. A plurality of fittings 186 (individually identified as first through fourth fittings 186a-d) are attached to the housing 180 and aligned with openings 185 (individually identified as first through fourth openings 185a-d) in the housing 180 to provide a means for coupling the shunt device to the conduit 102 ( Figure 6 ) and / or reservoir 114 ( Figure 6 ) of the fluid line (e.g., through Figure 6 The flow diversion device 112 further includes a flow control assembly 188 (e.g., a shaft) disposed along or within the engagement structure 184 and a handle 190 operably coupled to the flow control assembly 188. The flow control assembly 188 is movable longitudinally and / or rotationally along the engagement structure 184 to selectively form one or more fluid paths 182 (respectively, at a plurality of channels 212) along a subset of the channels 212. Figure 7A and 7B 144a and 144b).

[0065] like Figure 7A As shown, when the flow control assembly 188 is placed in a first position (e.g., via the handle 190), the fluid control assembly 188 defines a first fluid path 182a and a second fluid path 182b for removing and delivering fluid to different chambers 144 of the delivery system 100. In the illustrated embodiment, for example, the second path 182b allows fluid to flow from the fourth fitting 186d toward the first fitting 186a toward the first chamber 144a, and the first fluid path 182a allows fluid to be discharged from the second chamber 144b. This simultaneous or concurrent delivery and removal of fluid through the two paths 182 collectively causes the delivery system 100 to move from the contained configuration to the deployed configuration and enables deployment of the prosthetic heart valve device 110.

[0066] like Figure 7B As shown, when the flow control assembly 188 is in the second position, the fluid control assembly 188 defines a third fluid path 182c and a fourth fluid path 182d to remove and deliver fluid to different chambers 144. In the illustrated embodiment, for example, the third path 182c allows fluid to be exhausted from the second chamber 144b, while the fourth path 182d allows fluid to flow toward the first chamber 144a. This concurrent movement of fluid into and out of the chambers 144 moves the delivery system 100 from the deployed or partially deployed configuration to the stowed configuration, thereby enabling the retrieval of the prosthetic heart valve device 110.

[0067] Thus, movement of the fluid control assembly 188 between the first and second positions enables the opening 185 and associated fitting 186 to alternately function as an outlet and an inlet depending on whether the delivery system is moving toward a deployed configuration for unsheathing the prosthetic heart valve device 110 or toward a contained configuration for unsheathing the prosthetic heart valve device 110 or removal of the entire delivery system 100. In the illustrated embodiment, for example, the first opening 185a and associated first fitting 186a function as an outlet when the flow control assembly 188 is in the first position for deploying the device and as an inlet when the flow control assembly 188 is in the second position for retracting the device or removing the system. Concurrently, the second opening 185b and second fitting 186b function as an inlet when the flow control assembly 188 is in the first position and as an outlet when the flow control assembly 188 is in the second position. The third opening 185c and the associated third fitting 186c can be used as an outlet, regardless of whether the flow control assembly 188 is in the first or second position, to provide a consistent fluid discharge location, and the fourth opening 185d and the associated fitting 186d can be used as an inlet, to supply fluid to one or both chambers 144, regardless of the position of the flow control assembly 188. This enables the third fitting 186c and the fourth fitting 186d to remain connected to the fluid retention or discharge reservoir and the fluid supply reservoir, respectively, throughout the delivery process. In other embodiments, the flow diverter device 112 can be configured so that the direction of the fluid passing through the third fitting 186c and the fourth fitting 186d can be reversed based on a change in the position of the fluid control assembly 188.

[0068] During use, when the delivery capsule 106 is delivered to a target site at a native heart valve (eg, via a transapical or transseptal delivery approach), the system 100 is arranged in the contained configuration ( Figure 7A). In order to completely or partially unsheath the artificial heart valve device 110, the handle 190 is manipulated to move the fluid control assembly 188 to the first position. This allows the fluid to flow along the first fluid path 182b through the first fitting 186a (as indicated by arrow 157), reach the second fluid line 152b, and enter the second chamber 144b. When the fluid is delivered to the second chamber 144b, the fluid is also discharged from the first chamber 144a toward the second fitting 186b (as indicated by arrow 159) through the first fluid line 152a and through the second fluid path 182b. In some embodiments, the fluid is transferred to the second chamber 144b and from the first chamber 144a simultaneously and optionally in equal amounts, so that the same amount of fluid transferred from the first chamber 144a is transferred to the second chamber 144b. In some embodiments, different amounts of fluid are discharged from the chamber 144 and transferred to the chambers. This concurrent fluid transfer between chambers 144 drives housing 126 proximally in the direction of arrow 153 to deploy prosthetic heart valve device 110 .

[0069] exist Figure 7B In the deployed configuration shown, the delivery capsule 106 axially restricts the outflow portion of the prosthetic heart valve device 110 while the inflow portion of the prosthetic heart valve device 110 is deployed from the delivery capsule 106. After at least partial deployment, the fluid chamber 144 can be pressurized and vented in the opposite manner to move the housing 126 distally (in the direction of arrow 155) back to the contained configuration and at least partially resheath the prosthetic heart valve device 110. To resheath, the handle 190 is manipulated to move the flow control assembly 188 to the second position. This allows fluid to flow from the second chamber 144b through the second fluid line 152b into the fitting 186a (indicated by arrow 161) and out along the third fluid path 182c. When the fluid leaves the second chamber 144b, it is also delivered to the first chamber 144a. That is, the fluid moves through the fourth fluid path 182d, through the second fitting 186b, and reaches the first fluid line 152a (as indicated by arrow 163). 144a and out of the second chamber 144b. The housing 126 distally drives the prosthetic heart valve device 110 in the direction of arrow 155 to controllably resheath the prosthetic heart valve device 110 so that at least a portion of the prosthetic heart valve device 110 is repositioned within the compartment 146. The hydraulic movement of the housing 126 can provide for controlled deployment and resheathing of the prosthetic heart valve device 110.

[0070] As the delivery capsule 106 moves between the contained configuration and the deployed configuration, the housing 126 slidably moves relative to the longitudinal axis of the shaft 148, while the prosthetic heart valve device 110 at least substantially maintains its longitudinal position relative to the catheter body 108. That is, when the prosthetic heart valve device 110 is in the contained configuration ( Figure 7A ) and expanded configuration ( Figure 7B ), the delivery capsule 106 can substantially prevent longitudinal translation of the prosthetic heart valve device 110 relative to the catheter body 108. This enables the clinician to position the sheathed prosthetic heart valve device 110 at a desired target site for deployment and then deploy the device 110 at the target site without having to compensate for any axial movement of the device 110 as it reaches full expansion (e.g., as would be necessary if the device 110 were advanced distally from the housing 126).

[0071] like Figure 7A and 7B As further shown, the system 100 may also include a biasing device 168 that acts on the housing 126 to urge the housing 126 toward the contained configuration. Figure 7B ), the biasing device 168 compresses to exert more force on the housing 126 in the distal direction toward the contained configuration. In some embodiments, the biasing device 168 continuously acts on the housing 126 to urge it toward the contained configuration, and in other embodiments, the biasing device 168 acts on the housing 126 only when it is compressed during deployment. In the illustrated embodiment, the biasing device 168 is positioned within the distal portion 108b of the catheter body 108, but in other embodiments, the biasing device 168 can be positioned in other parts of the system 100, such as in the handle or control unit 104 ( Figure 6 ). The biasing device can be a spring or other feature that urges the housing 126 and / or other portions of the delivery capsule 106 toward the contained configuration. The biasing device 168 limits or substantially prevents the delivery capsule 106 from opening due to the forces generated by expanding the prosthetic heart valve device 110. For example, the unsheathed portion of the prosthetic heart valve device 110 can expand outward from the partially opened delivery capsule 106 while the biasing device 168 prevents the delivery capsule 106 from further opening.

[0072] Figure 8A and 8B 1 and 2 show top and bottom views, respectively, of a shunt device 200 according to an embodiment of the present technology, the shunt device being configured to control fluid flow to deploy and retract an implantable device (e.g., an artificial heart valve device). Figure 6-7BThe system 100 described above is used to facilitate deployment of the prosthetic heart valve device 110 at a target site (e.g., a native mitral valve, a native tricuspid valve, a native aortic valve). The shunt device 200 may include a valve generally similar to that described above with respect to Figure 6-7B Various features of the features of the diverter device 112 described herein may be described. For example, the diverter device 200 includes a housing 202 coupled to an actuator or handle 204, and the handle 204 can be switched between at least two positions to change the path and / or direction of fluid flow through the diverter device 200. In some embodiments, for example, changing the handle position enables the diverter device 200 to alternately deliver fluid to multiple delivery system chambers (e.g., Figure 7A and 7B The shunt device 200 and its parts can be made of a variety of materials. For example, the housing 202 and / or the handle 204 can be made of a rigid or semi-rigid polymer, plastic, metal, and / or other mechanically strong material.

[0073] The flow diverter device 200 includes a plurality of apertures or openings 203 (individually identified as first through fourth openings 203a-d) in a housing 202 and a corresponding plurality of connectors or fittings 206 (individually identified as first through fourth fittings 206a-d) that are at least partially aligned with the openings 203. In the illustrated embodiment, the housing 202 includes four openings 203, and four fittings 206 are coupled to the housing 202 at corresponding openings 203. In other embodiments, the flow diverter device 200 may include fewer than four or more than four openings 203 and / or fittings 206. The fittings 206 may receive or otherwise fluidly couple with one or more hoses, tubes, fluid lines, and / or other components (e.g., connectors, valves, pumps) that may simultaneously deliver fluid to a reservoir (e.g., Figure 6 Reservoir 114), a fluid chamber in a delivery catheter assembly (e.g., Figure 7A and 7B For example, in the illustrated embodiment, the first fitting 206a and the second fitting 206b can be coupled to the conduit 108 ( Figure 6-7B) of the corresponding chambers 144 of the conduit 108. The third fitting 206c can be coupled to a tube in fluid communication with an inflator device (e.g., a reservoir of an inflator) that is filled with pressurized fluid that can be transferred to one or more chambers 144 through the flow diverter device 200. The fourth fitting 206d can be coupled to a tube in fluid communication with a drain line (e.g., a reservoir) that can receive fluid discharged from one or more of the chambers 144 of the conduit 108.

[0074] like Figure 8B As shown, the shunt device 200 can include a connection device 208 that secures the shunt device 200 to an inflation mechanism that is provided to the delivery catheter 108 ( Figure 6-7B ) of the part and / or delivery system (e.g., Figure 6 The connection device 208 can include a bracket 209 and a knob 210 that is operably connected to a compression member 211 (e.g., a screw) that adjusts the size of the bracket 209 to clamp onto a portion of the delivery system. Figure 11 For example, the connecting device 208 can be positioned so that the bracket 209 extends around a portion of the inflator device 228, and the knob 210 can be rotated to adjust the size of the bracket 209 (e.g., the position of the adjustment screw) so that the connecting device 208 applies pressure to the inflator device 228 to secure the inflator device 228 and the diverter device 200 together. Figure 11 In the illustrated embodiment, the connecting device 208 is coupled to the fluid reservoir 230 of the inflator device 228. However, in this and other embodiments, the connecting device 208 can be coupled to other portions of the inflator device 228 or other portions of the delivery system. In other embodiments, the connecting device 208 can removably secure the flow diverter device 200 to the inflator device and / or other components via automatically adjustable spring-loaded engagement arms, a lever clamping mechanism, adhesives, and / or other suitable attachment devices.

[0075] Figure 9A and 9B An embodiment of the present invention is shown in two different configurations. Figure 8A and 8B A partial cross-sectional view of the diversion device 200. Specifically, Figure 9A A first chamber that facilitates the transfer of fluid to and from a second chamber of a hydraulic delivery system (e.g., Figure 7A and 7B The first arrangement of the delivery system 100 chamber 144) transfers the fluid. Figure 9BA second arrangement is shown that facilitates fluid flow in a direction opposite to the first arrangement such that fluid flows out of the first chamber and into the second chamber. Flow diverter device 200 provides a change in the direction and / or path of fluid flow in a delivery system to deploy and / or retract a prosthetic heart valve device.

[0076] like Figure 9A and 9B As shown, the housing 202 defines or contains a network of channels 212 that intersect at a junction structure 214, and the openings 203 and associated fittings 206 define inlets and / or outlets of the network of channels 212. The junction structure 214 can be defined by an inner surface or wall of the housing 202 in which a hole (e.g., a bore) is formed and / or by a separate open tube or structure extending through a portion of the housing 202. A flow control assembly 216 is disposed at the junction structure 214 and is movable longitudinally and / or rotationally within the junction structure 214 to selectively form a plurality of different fluid paths 218 (shown in phantom; individually identified as first through fourth paths 218a-d) based on the orientation of the flow control assembly 216 relative to the channels 212. The flow control assembly 216 can be a shaft or other structure having a plurality of openings and fluid channels 212 extending therethrough, such that relative movement of the flow control assembly 216 within the engagement structure 214 can align one, two, or more selected fluid channels 212 of the flow control assembly 216 with selected channels 212 of the housing 202 that are in fluid communication with the openings 203. In various embodiments, the flow control assembly 216 can include different or additional structures or features that allow for selective activation of the fluid pathways 218 through the flow diverter device 200. In some embodiments, the diameter of the flow control assembly 216 relative to the engagement structure 214 is selected to avoid excessive fluid flow between the fluid control assembly 216 (e.g., the shaft) and the inner wall of the engagement structure 214 (e.g., the inner surface defining the bore) that could adversely affect fluid delivery to the delivery catheter. The fluid control assembly 216 and the engagement structure 214 can be made of a variety of materials that are mechanically strong but reduce friction. For example, the fluid control assembly 216 may be made of a polycarbonate material and the engagement structure 214 may be made of a metal (eg, steel), and both features may be coated with a substance that reduces friction therebetween.

[0077] In some embodiments, the joint structure 214 includes a plurality of sealing members 226 (individually identified as first through fourth sealing members 226a-d) positioned at various locations along the flow control assembly 216 to form sealed compartments (i.e., between the sealing members 226a-d). In the illustrated embodiment, the sealing members 226 are O-rings (e.g., coated rubber O-rings) positioned around an outer surface of the fluid control assembly 216 (e.g., a shaft) and in contact with an inner wall of the joint structure 214 (e.g., an inner surface defining a bore). In some embodiments, at least some of the sealing members 226 may be of a different structure that provides a seal between portions of the flow control assembly 216 and the joint structure 214 while still allowing the flow control assembly 216 to move relative to the joint structure 214. Movement of the flow control assembly 216 relative to the joint structure 214 moves the compartments between the plurality of sealing members 226 into or out of alignment with the channel 212 to selectively form the pathway 218.

[0078] exist Figure 9A , the flow control assembly 216 is arranged in a first position to define first and second paths 218a-b providing fluid communication through the channel network 218 between the openings 203. In the illustrated embodiment, the flow control assembly 216 is placed in the first position by moving longitudinally along the engagement structure 214 in the direction of arrow 220.

[0079] exist Figure 9B In the embodiment, the flow control assembly 216 is arranged in a second position to define a third path and a fourth path 218c-d that provide fluid communication through the channel network 218. Figure 9A The first position of the flow control assembly 216 is shown longitudinally moved in the direction of arrow 222 to place the flow control assembly 216 in the second position.

[0080] like Figure 9A and 9B As shown, when the flow control assembly 216 is in the first position ( Figure 9A ), the opening 203c associated with the third fitting 206c defines the inlet of the first path 218a, and when the fluid control assembly 216 is in the second position ( Figure 9B ), similarly defining the inlet of the third path 218c. Thus, depending on the position of the fluid control assembly 216, the third fitting 218c can be coupled to a fluid reservoir (e.g., Figure 6 The first reservoir 114a of the delivery system is connected to a fluid delivery device (e.g., an inflator) that can supply pressurized fluid to the diverter device 200 and thereby to the first chamber or the second chamber of the delivery system (e.g., Figure 6-7BThus, the third fitting 206c and the associated opening 203c can define an inlet regardless of whether the delivery system is in the deployed mode or the retracted mode. Additionally, when the fluid control assembly 216 is in the first position ( Figure 9A ), the opening 203d of the fourth fitting 206d can define an outlet of the second path 218b, and when the fluid delivery assembly 216 is in the second position ( Figure 9B ) can also define an outlet for the fourth pathway 218d. In this manner, the fourth fitting 206d and associated opening 203d can be coupled to a drain line or fluid receiver that receives fluid from any of the chambers of the delivery catheter via the diverter 200, regardless of the arrangement of the fluid control assembly 216. Thus, the fluid control device 200 enables swapping between fluid delivery to and from different chambers of the delivery system without requiring relocation of the fluid delivery assembly or the fluid drain assembly. Further, the fluid control device 200 is able to accomplish this fluid swap through simple manipulation of a single component (i.e., handle 204) and without requiring undue force on the part of the clinician in effecting the change between delivery and retrieval of the implantable device.

[0081] Although described in terms of the inlet and outlet of the flow diverter device 200 being configured to pass fluid in certain directions depending on the position of the flow control assembly 216, those skilled in the art will appreciate that this is a relative interconnection arrangement that can be achieved through different interconnection arrangements. For example, the description of the relative fluid flow between the flow diverter device 200 can be changed by swapping the connection between the two chambers so that, for example, when the flow control assembly 200 is in the first position, the second chamber is filled and the first chamber is emptied.

[0082] The flow control assembly 216 can be operably coupled to the handle 204 and / or other control structure such that manipulation of the handle 204 (e.g., switching, turning, pushing) moves the orientation of the flow control assembly 216 within the engagement structure 214 to a predefined first position and a second position. In some embodiments, the handle 204 is operably coupled to the flow control assembly 216 via a pin and / or other connection structure and can be rotated about an axis 224 for positioning. Rotation of the handle 204 about the axis 224 to a predetermined position (e.g., a first handle position and a second handle position) can move the flow control assembly 216 to the first position (e.g., a second handle position). Figure 9A ) and a second position (e.g., Figure 9B In the illustrated embodiment, the first handle position ( Figure 9A ) is when the handle 204 is rotated 90 degrees from the middle position, and the second handle position ( Figure 9B) is a 90-degree rotation of handle 204 from a first handle position. In some embodiments, handle 204 can be rotated about axis 224 to different angles to achieve different positions of flow control assembly 216, handle 204 can have additional positions associated with additional positions of flow control assembly 216, and / or handle 204 can be manipulated in different or additional ways to accomplish movement on flow control assembly 216.

[0083] Figure 10A and 10B yes Figures 8A-9B 200, which further illustrates the interaction of the fluid control component 216 with the engagement structure 214 to pass through the channel network 212 ( Figure 9A and 9B ) produces various fluid paths 218. Figure 10A The diverter device 200 is shown in a first or deployed configuration, and Figure 10B The diverter device 200 is shown in a second or retracted configuration.

[0084] like Figure 10A As shown, when the diverter device 200 is in the deployed configuration, the flow control assembly 216 is in the first position. Figures 8A-9B ) is manipulated to a predetermined position, the flow control assembly 216 can be moved to this position, which causes the flow control assembly 216 to move in the direction of arrow 220. In the first position, the flow control assembly 216 forms a first path 218a and a second path 218b. The first path 218a can make a fluid reservoir (e.g., Figure 6 The inflator device of the first reservoir 114a) is connected to the deployment chamber in a portion of the delivery catheter (e.g., Figures 7A-7B The second path 218b can be fluidically connected to the re-sheathing chamber of the delivery catheter (e.g., Figures 7A-7B another chamber in the chamber 144 of the chamber) and a discharge or receiver reservoir (e.g., Figure 6 14b) are placed together. Thus, in the deployed configuration, the shunt device 200 allows the deployment chamber to be filled by the inflator device through the first path 218a and removes fluid from the resheathing chamber through the second path 218b to reach the drain line. In some embodiments, the shunt device 200 allows for simultaneous delivery of fluid to and removal of fluid from the delivery catheter, and in other embodiments, these steps are performed sequentially. Delivery of fluid to one chamber of the delivery system and removal of fluid from another chamber of the delivery system can initiate unsheathing of the delivery capsule from an implantable device (e.g., a prosthetic heart valve) to allow the device to expand and / or deploy in vivo.

[0085] like Figure 10B As shown, when the diverter device 200 is in the retracted configuration, the flow control assembly 216 is in the second position. Figures 8A-9B ) to a predetermined position, the flow control assembly 216 can be moved from the intermediate position or the first position ( Figure 10A ) moves to a second position, which causes the flow control assembly 216 to move in the direction of arrow 222. In the second position, the flow control assembly 216 uses at least some of the same channels 212 ( Figures 9A-9B ) to define a third pathway 218c and a fourth pathway 218d, but redefine the connection therebetween. The third pathway 218c can place the inflator device in fluid communication with the resheathing chamber of the delivery catheter to allow fluid to be delivered to the resheathing chamber. The fourth pathway 218d can place the deployment chamber of the delivery catheter in fluid communication with the drain line to allow fluid to be removed from the deployment chamber. Delivering fluid to one chamber of the delivery system and removing fluid from another chamber of the delivery system in a manner opposite to the deployment configuration can initiate resheathing or retraction of an at least partially deployed device (e.g., a prosthetic heart valve) and / or closing the delivery capsule prior to removing the delivery system from the body.

[0086] Figures 12A-12C is a top view of a flow diverter 250 in various flow arrangements according to other embodiments of the present technology, and Figure 13 yes Figures 12A-12C Exploded view of the diverter device 250. Similar to Figure 9A-11 The diversion device 200, Figure 12A-13 The flow diverter device 250 is configured to control fluid flow in a hydraulic delivery system (e.g., Figure 6 The shunt device 250 can be configured to define a path and direction in a delivery system 100 to deploy and / or retract an artificial heart valve and / or other implantable device. The shunt device 250 includes a housing 252 coupled to a control mechanism or handle 254. The housing 252 can include a plurality of channels 260 (each independently identified as a first channel to a fourth channel 260a-260d) that terminate at a plurality of openings 256 (each independently identified as a first opening to a fourth opening 256a-d) accessible from the exterior of the housing 252 and intersect at a joining structure 262. The handle 254 can be rotated or otherwise moved to at least two different positions to selectively change the fluid path defined along the channels 260 and thereby allow fluid delivery to and from the two chambers of the delivery system, thereby enabling deployment and retraction of the implantable device from the delivery capsule of the delivery system.

[0087] The shunt 250 can be made of a variety of rigid, semi-rigid, or flexible materials. For example, the housing 252 can be made of injection-molded plastic or another mechanically strong rigid material. The handle 254 and other components of the shunt 250 can also be made of polymers, metals, and / or other mechanically strong materials.

[0088] In the embodiment shown, housing 252 defines four openings 256 corresponding to four passages 260 extending from engagement structure 262. In other embodiments, housing 252 can include less than four or more than four openings 256. In this and other embodiments, housing 252 can include less than four or more than four passages 260 intersecting with engagement structure 262. Each opening 256 can accommodate one or more hoses, pipes, or other components (e.g., connectors, valves, pumps) for delivering flowable materials (e.g., liquid, saline, water) between a fluid reservoir, a discharge line, and a chamber positioned in the delivery capsule, along a conduit, in the handle of a conduit, and / or in other parts of a hydraulic delivery system. For example, first opening 256a and second opening 256b can accommodate a pipe connecting diverter 250 fluid to the corresponding chamber of a delivery conduit. The third opening 256c can receive tubing that fluidically connects the shunt device 250 to a drain or reservoir configured to receive fluid removed from one or more chambers of the delivery catheter. The fourth opening 256d can receive tubing that fluidically connects the shunt device 250 to a fluid reservoir, such as an inflator device (e.g., Figure 11 The fluid reservoir of the inflator device 228) can be delivered to one or more chambers of the delivery catheter. Thus, the opening 256 can define an inlet and / or outlet for the channel network 260 of the components entering / exiting the external part of the diverter device 250.

[0089] like Figure 13As shown in a partially exploded view of FIG, the flow diverter device 250 can further include a flow control assembly 266 at least partially disposed within the engagement structure 262 and operably coupled to the handle 254. In the illustrated embodiment, the engagement structure 262 includes a central tubular structure 268, a plurality of tubular arms 269 extending radially outward from the central tubular structure 268 aligned with a corresponding plurality of channels 260, and an engagement aperture 271 configured to receive the flow control assembly 266. When the upper housing portion 252a and the lower housing portion 252b are combined, the central tubular structure 268 and the tubular arms 269 can be securely housed within the housing 252 of the flow diverter device 250. In other embodiments, the engagement structure 262 can be integrally formed (e.g., molded) with the housing 252 and / or otherwise secured within the housing 252. In this and other embodiments, the engagement structure 262 can have different configurations, such as a single tubular shaft without tubular arms, a tube with arms spaced apart in a configuration different from that shown, and / or other suitable engagement mechanisms for supporting the flow control assembly 266 and connecting with the channel 260.

[0090] The flow control assembly 266 includes a body portion 273, such as a shaft or other structure, rotatably received within an orifice 271 of the engagement structure 268. The body portion 273 includes one or more flow channels 270 (e.g., two flow channels, three flow channels, four flow channels, more than four flow channels) extending through the body portion 273. The one or more diameters of the flow channels 270 are such that the flow channels can facilitate delivery of fluid at an appropriate pressure and velocity to the catheter.

[0091] During use, rotation of the handle 254 rotates the flow control assembly 266 relative to the engagement structure 262. This rotation aligns the diverter channel 270 of the flow control assembly 266 with the main channel 260 in the housing 252 and thereby selectively defines a plurality of fluid paths 264 (individually identified as first through fifth fluid paths 264a-e; Figures 12A-12C For example, rotation of the handle 262 can rotate the body portion 273 of the flow control assembly 266 between at least a first position (e.g., a deployed configuration) and a second position (e.g., a retracted configuration) such that the diverter channel 270 is selectively aligned with the main channel 260 to enable fluid flow for device delivery and retrieval.

[0092] During use, the diverter device 250 can have two or more functional configurations for delivering fluid to or from different components of the delivery system. Figure 12A-13 In the illustrated embodiment, the diversion device 250 has three functional configurations: Figure 12A The expanded configuration shown, Figure 12BThe retracted configuration shown, and Figure 12C An intermediate filling configuration is shown for optional filling of the inflator device during delivery. The flow diverter device 250 may also have a fourth configuration in which all of the channels 260 are blocked.

[0093] refer to Figure 12A When the flow diverter device 250 is in the deployed configuration, fluid can flow from the inflator device (e.g., Figure 11 The inflator device 228) or other fluid reservoir flows into the fourth opening 256d, through the engagement structure 262 and the flow control assembly 266 ( Figure 13 ), out of the second opening 256b and into a lumen (e.g., a deployment lumen) of the delivery catheter. In some embodiments, the deployment configuration enables simultaneous or concurrent discharge of fluid along a first path 262a, in which fluid can flow from the resheathing lumen of the delivery catheter into the first opening 256a, through the engagement structure 262 and the flow control assembly 266, through the third opening 256c and into a drain line and / or reservoir.

[0094] like Figure 12B As shown, when the diverter device 250 is in the retracted configuration, fluid can flow from the inflator device along a fourth path 262d into the fourth opening 256d, through the engagement structure 262 and the flow control assembly 266 therein, through the first opening 256a, and into the resheathing chamber of the delivery catheter. In some embodiments, the retraction configuration also enables the removal of fluid from the deployment chamber of the delivery catheter via a third path 262c. In this arrangement, fluid can flow from the deployment chamber to the second opening 256b, through the engagement structure 262 and the flow control assembly 266 therein, through the third opening 256c, and into the drain reservoir or line. Thus, Figure 12B The retracted state of the diverter device 250 shown in FIG. Figure 12A The expanded state of the shunt device shown in FIG is opposite to the expanded state of the shunt device shown in FIG, which is achieved by removing the handle 254 (and the flow control assembly 266 coupled thereto) from the Figure 12A The first position shown is rotated to Figure 12B The second position shown enables fluid to move in the opposite direction from the corresponding lumen of the delivery catheter.

[0095] In both the deployed and retracted configurations of the diverter device 250, the fourth opening 256d defines an inlet to the diverter device 250, whether the inlet is for the second path 262b used during the deployed configuration or the fourth fluid path 262d used during the retracted configuration. Thus, depending on the configuration of the flow control assembly 250, the fourth opening 256d can be coupled to an inflator device, such as a device containing pressurized fluid for delivery to either the first chamber or the second chamber of the diverter device 250 and the delivery catheter. Similarly, when the diverter device 250 is in the deployed configuration ( Figure 12A ) or retract the configuration ( Figure 12B ), the third opening 256c defines an outlet for each of the first path 262a and the third path 262c of the flow diverter device 250. Thus, depending on the configuration of the flow diverter device 250, the third opening 256c can be coupled to a reservoir, receiver, and / or drain that can receive fluid from either the first chamber or the second chamber.

[0096] like Figure 12C As shown, when the diverter device 250 is in the optional filling configuration, the diverter device 250 allows fluid to flow along the fifth path 262e from the third opening 256c to the fourth opening 256d to connect the inflator device or reservoir with the fluid reservoir (e.g., the exhaust reservoir), thereby allowing the inflator device to be refilled. In various embodiments, before the device is deployed or retracted, when the delivery system (e.g., Figure 6 This intermediate configuration may be employed when deploying a system 100). For example, during initial setup, the inflator device may be filled via the fifth path 262e used to flush the delivery system to remove air pockets. This may deplete the fluid supply contained in the inflator device, making it insufficient for deployment and / or recovery procedures. Figure 12C The filling configuration enables rapid refilling of the inflator device or fluid reservoir without removing the inflator device from the shunt device 250. In various embodiments, this filling configuration can also be used during delivery if additional fluid is required for device delivery, flushing, and / or retrieval.

[0097] Although described with respect to certain openings of the flow diverter 250 being configured to transfer fluid in certain directions depending on the position of the flow control assembly, those skilled in the art will appreciate that this is a relative interconnection arrangement that can be achieved with other interconnection arrangements. For example, the description of the relative fluid flow between the diverter 250 can be changed by swapping the connections between the two chambers.

[0098] In some embodiments, the shunt device 250 may further include a connection assembly 258 (including parts 258a and 258b) that releasably secures the shunt device 250 to a portion of a delivery system (e.g., Figure 11 The connecting assembly 258 may be a bracket structure that applies a resistive force to the components held within the connecting assembly 258. Figure 13 As shown, for example, the connection assembly 258 is formed by joining a first bracket surface portion 275a and a second bracket surface portion 275b on opposite sides of the housing 252. As shown, the bracket surface portion 275 can have a larger surface area to enhance the attractive force on the inflator device. In other embodiments, the connection assembly 258 can include different attachment mechanisms for releasably securing the diverter device 250 to other components of the delivery system.

[0099] Although described with reference to applications involving implantation of artificial valve devices, the disclosed embodiments are not limited thereto. Figure 6-13 The disclosed embodiments of the shunt devices described can be configured to enable delivery of various other medical devices in addition to or as an alternative to prosthetic valve devices for replacing the mitral valve and / or other valves in a patient's heart. Specific elements, substructures, advantages, uses, and / or other features described herein can be interchanged, replaced, or otherwise configured to include one another, as appropriate. Furthermore, appropriate elements of the described embodiments can be used as stand-alone devices and / or self-contained devices.

[0100] From the foregoing, it will be appreciated that specific embodiments of the present disclosure have been described herein for illustrative purposes, but various modifications may be made without departing from the scope of the present disclosure. Accordingly, the present disclosure is not to be limited except by the appended claims.

Claims

1. A flow shunt device for controlling fluid flow in a delivery system for deploying a prosthetic heart valve device, the flow shunt device comprising: A housing, comprising: a plurality of channels intersecting at a junction; as well as a plurality of openings of the plurality of channels, the plurality of openings being in fluid communication with the junction, wherein the plurality of openings comprises a first opening and a second opening; a flow control assembly comprising a shaft having a plurality of openings and fluid passages extending therethrough, the shaft being disposed at the joint and being movable longitudinally and / or rotationally to selectively form a plurality of paths based on a position of the shaft, the plurality of paths including a first path and a second path for fluid communication between the plurality of openings through the plurality of passages, wherein: When the shaft is in the first position, the first path is formed to allow fluid to flow through at least the first opening toward the first chamber of the delivery system to cause the prosthetic heart valve device to deploy, and When the shaft is in the second position, the second path is formed to allow fluid to flow through at least the second opening toward a second chamber of the delivery system to cause retraction of the prosthetic heart valve device; as well as A single handle operably coupled to the shaft and movable in a single motion to position the shaft in at least either of the first position and the second position to selectively permit fluid flow toward at least either of the first chamber or the second chamber of the delivery system.

2. A shunt device according to claim 1, wherein when the shaft is in the first position, a third path is formed to discharge fluid from the second chamber, and the first path allows fluid to flow toward the first chamber of the delivery system to jointly cause the artificial heart valve device to expand.

3. A shunt device according to claim 2, wherein when the shaft is in the second position, a fourth path is formed to discharge fluid from the first chamber, and the second path allows fluid to flow toward the second chamber of the delivery system to jointly cause the artificial heart valve device to be retracted.

4. The flow diversion device according to claim 3, wherein the housing further comprises: a third opening of the plurality of openings, the third opening forming an outlet of the third path when the shaft is in the first position and forming an outlet of the fourth path when the shaft is in the second position; as well as A fourth opening of the plurality of openings forms an entrance to the first path when the shaft is in the first position and forms an entrance to the second path when the shaft is in the second position.

5. The diverter device of claim 1, further comprising a bracket structure configured to receive and retain an inflator device to the housing of the diverter device.

6. The flow diverter device of claim 1, wherein the shaft is disposed in the bore of the housing and is longitudinally movable to selectively form any one of the plurality of paths based on a longitudinal position of the shaft relative to the bore. 7 . The flow dividing device according to claim 6 , further comprising a plurality of sealing members disposed at different positions of the shaft to form sealed compartments, the sealed compartments being movable to selectively form the plurality of paths.

8. The flow diverter device of claim 7, wherein each of the plurality of sealing members is an O-ring disposed about the shaft.

9. The shunt device of claim 6, wherein the handle is operable to switch the shaft between the first position and the second position. 10 . The flow dividing device according to claim 1 , wherein the shaft is disposed in the joint and is rotatable to selectively form any one of the plurality of paths based on a rotation angle of the shaft.

11. The flow diverter device of claim 10, wherein the shaft comprises at least one rotatable channel that selectively forms any one of the plurality of paths based on a rotation angle of the shaft.

12. The flow diverter device of claim 10, wherein the flow diverter device comprises a four-way stopcock having three functional positions for diverting fluid flow.

13. The flow diverter device of claim 10, wherein when the shaft is in the third position, a fifth path is formed to allow fluid to flow toward the inflator through a third opening of the plurality of openings.

14. The shunt device of claim 10, wherein the shunt device is configured to be external to the patient during an implantation procedure of the prosthetic heart valve device.

15. A system for delivering a prosthetic heart valve device into a patient's heart, the system comprising: an elongated catheter body containing a delivery control assembly that is hydraulically actuated to deploy and retract the prosthetic heart valve device relative to the heart of the patient; as well as A diversion device, the diversion device comprising: a housing comprising a plurality of openings of a plurality of channels intersecting at a junction; a flow control assembly comprising a shaft having a plurality of openings and fluid passages extending therethrough, the shaft being disposed at the joint and being movable longitudinally and / or rotationally to selectively form a plurality of paths for fluid communication between the plurality of openings through the plurality of passages based on a position of the shaft, wherein: When the shaft is in a first position, a first path is formed to allow fluid to 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 when the shaft is in a second position, forming a second path to allow fluid to flow through a second opening of the plurality of openings to retrieve the prosthetic heart valve device from the heart of the patient by exhausting the first chamber of the system; as well as A single handle is movable in a single motion to change the position of the shaft between the first position and the second position to select from the plurality of paths for fluid communication with the first chamber.

16. The system of claim 15, wherein when the shaft is in the first position, a third path is formed to allow fluid to flow through a third opening of the plurality of openings to deploy the prosthetic heart valve device into the heart of the patient by exhausting the second chamber of the system.

17. The system of claim 16, wherein when the shaft is in the second position, a fourth path is formed to allow fluid to flow through a fourth opening of the plurality of openings to withdraw the prosthetic heart valve device from the patient's heart by filling the second chamber of the system.

18. The system of claim 17, further comprising a handle of the elongated catheter body, the handle of the elongated catheter body containing the second lumen.

19. The system of claim 17, wherein the delivery control component comprises the second chamber.

20. A shunt device for controlling fluid flow in a system configured to implant a medical device in a patient, the shunt device comprising: a housing comprising a plurality of openings of a plurality of channels intersecting at a junction; a flow control assembly comprising a shaft having a plurality of openings and fluid passages extending therethrough, the shaft being disposed at the joint and being movable longitudinally and / or rotationally to form a plurality of paths for fluid communication between the plurality of openings based on a position of the shaft, wherein: When the shaft is in the first position, a first path is formed to allow fluid to flow through a first opening of the plurality of openings toward a first chamber of the delivery control assembly to cause deployment of the medical device; and forming a second path to allow fluid to flow through a second opening of the plurality of openings toward a second chamber to cause retraction of the medical device when the shaft is in a second position; and a single handle operably coupled to the shaft and movable in a single motion to change the position of the shaft between at least the first and second positions to selectively establish any one of the plurality of pathways for fluid communication with the first and second chambers of the delivery control assembly.

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