Fluid flow diversion device for hydraulic delivery system and related methods

Abstract

A fluid diversion device configured according to an embodiment of the present technology may include, for example, a housing and a hole, the housing including a channel configured to receive a corresponding tube, the hole extending transversely through the multiple channels. The device may include a blocking member disposed in the hole, wherein rotation of the blocking member selectively blocks the first tube set or the second tube set. The device may include an actuator, the actuator being capable of rotating the blocking member to a first position and a second position, so that the first tube set and the second tube set are alternately blocked in the first position or the second position for fluid communication in different directions relative to a chamber of a delivery device, the delivery device being operable to deploy and retract a medical device.

Description

[0001] This application claims the benefit of U.S. Provisional Patent Application No. 62 / 842,252, filed on May 2, 2019, entitled “FLUID DIVERSION DEVICES FOR HYDRAULIC DELIVERY SYSTEMS ANDASSOCIATED METHODS,” the entire contents of which are incorporated herein by reference. Technical Field

[0002] The present technology generally relates to hydraulic delivery systems for implanting medical devices. In particular, various embodiments of the present technology relate to cam-based fluid diversion devices and related methods for deploying hydraulic delivery systems for medical devices. 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 myocardial dilation, which in turn enlarges the native mitral annulus to the point where the leaflets will not coapt during systole. Abnormal regurgitation may also occur when the function of the papillary muscles is impaired due to ischemia or other conditions. More specifically, because the left ventricle contracts during systole, the affected papillary muscles do not contract adequately to achieve proper closure of the leaflets.

[0004] Mitral valve prolapse is a condition when 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) 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, typical repair techniques involve reducing or resecting portions of the dilated annulus. Reduction, for example, involves implanting an annular or nearly annular annulus that is typically fixed to the annulus or surrounding tissue. Other repair surgeries sew or clamp the valve leaflets to be juxtaposed to each other.

[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 usually require a large degree of open-heart surgery and are therefore very painful, have high morbidity, and require a long recovery period. In addition, in many repair and replacement surgeries, 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 skilled cardiac surgeon because improper or inaccurate placement of sutures may affect the success of the operation.

[0007] In recent years, less invasive methods of aortic valve replacement have been implemented. Examples of preassembled percutaneous prosthetic valves include, for example, the CoreValve from Medtronic / Corevalve Inc. (Irvine, CA, USA). System and Edwards- Valves. Both valve systems include an expandable frame and a three-leaflet bioprosthetic valve attached to the expandable frame. The aortic valve is substantially symmetrical, circular, and has a muscle ring. The expandable frame in aortic applications has a symmetrical circular shape at the aortic valve annulus to match the natural anatomical structure, and because the three-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 strong. However, other heart valve anatomy is uneven, asymmetrical, or not strong 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 deployment of the implant is critical and challenging due to the complex anatomy of the heart. Therefore, it is desirable that a delivery system can enable 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 describes a fluid diversion device for controlling fluid flow in a delivery system to deploy an artificial heart valve device, the fluid diversion device comprising: a shell, the shell comprising a first side, a second side, a hole, and a plurality of channels passing through the shell from the first side through the hole to the second side, wherein the plurality of channels are configured to receive a corresponding plurality of tubes, the plurality of tubes extending from the first side of the shell through the hole to the second side, and wherein the hole extends laterally through the plurality of channels; a blocking member disposed in the hole, wherein rotation of the blocking member enables selective blocking of a first set of tubes or a second set of tubes disposed in the plurality of channels; and an actuator, the actuator being operably connected to the blocking member so that the blocking member can be selectively positioned in at least a first position and a second position, the first position blocking the first set of tubes and the second position blocking the second set of tubes, for fluid communication in different directions relative to a first chamber and a second chamber of the delivery device to cause deployment and retraction of the artificial heart valve device.

[0010] In some examples, the present disclosure describes a system for delivering an artificial heart valve device into a patient's heart, the system comprising: an elongated catheter body, the elongated catheter body comprising a delivery control assembly, the delivery control assembly being hydraulically driven to deploy and retract the artificial heart valve device relative to the patient's heart; a plurality of chambers, the plurality of chambers comprising a first chamber and a second chamber, the first chamber and the second chamber being operable to receive or discharge a fluid, thereby hydraulically driving the deployment and retraction of the artificial heart valve device; and a fluid diversion device comprising: a shell, the shell comprising a first side, a second side, a hole, and a plurality of channels passing through the shell from the first side through the hole to the second side, wherein the plurality of chambers The channels are configured to receive a corresponding plurality of tubes extending from a first side of the housing through the hole to a second side, and wherein the hole extends transversely through the plurality of channels; a blocking member disposed in the hole, wherein rotation of the blocking member enables selective blocking of a first subset of tubes or a second subset of tubes disposed in the plurality of channels; and an actuator operably connected to the blocking member so that the blocking member can be selectively positioned in at least a first position and a second position, the first position blocking the first subset of tubes and the second position blocking the second subset of tubes, for fluid communication in different directions relative to the first chamber and the second chamber to cause deployment and retraction of the artificial heart valve device.

[0011] In some instances, the present disclosure describes a fluid diversion device for controlling fluid flow in a delivery system to deploy a medical device, the fluid diversion device comprising: a shell, the shell comprising a plurality of channels configured to receive a corresponding plurality of tubes, and a hole extending laterally through the plurality of channels; a blocking member disposed in the hole, wherein rotation of the blocking member selectively blocks a first subset of tubes among the plurality of tubes or a second subset of tubes among the plurality of tubes; and an actuator, the actuator being configured to enable the blocking member to rotate to at least a first position and a second position, so that the first set of tubes and the second set of tubes are alternately blocked in the first position or the second position, for fluid communication in different directions relative to the plurality of chambers of the delivery device, the delivery device being operable to deploy and retract the medical device. 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. Rather, emphasis is placed on clearly demonstrating the principles of the present disclosure. In addition, components may be shown as transparent in certain views for illustrative purposes only, without indicating that the components shown must be transparent. The titles provided herein are for convenience only.

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

[0014] Figure 2 is a schematic cross-sectional view 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 vascular system 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 vascular system 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 showing access to the native mitral valve using a transapical puncture in accordance with various embodiments of the present technology.

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

[0019] Fig. 7Ais in a containing configuration according to an embodiment of the present technology Figure 6 An enlarged partial cross-sectional view of a delivery system.

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

[0021] Figure 8 is an isometric view of a housing for a fluid diversion device configured in accordance with an embodiment of the present technology.

[0022] Fig. 9A It is a configuration according to an embodiment of the present technology Figure 8 An isometric view of the fluid diversion device of the housing.

[0023] Fig. 9B is in a first configuration according to an embodiment of the present technology Fig. 9A A top view of a fluid diversion device.

[0024] Fig. 9C Is in the first configuration Fig. 9B A side view of a fluid diversion device.

[0025] Fig.9D is in a second configuration according to an embodiment of the present technology Fig. 9A A top view of a fluid diversion device.

[0026] Fig.9E It is in the second configuration Fig.9D A side view of a fluid diversion device.

[0027] Fig. 10A and Fig. 10B An inflatable device is connected to the Fig. 9A The process of the fluid diversion device.

[0028] Fig.11A and Fig. 11B 2 are front isometric and rear isometric views, respectively, of a housing of a fluid diversion device configured in accordance with an embodiment of the present technology.

[0029] Fig. 12A is configured according to an embodiment of the present technology FIG. 11A to FIG. 11B Heterogeneous views of a fluid diversion device and associated fluid pipelines.

[0030] Fig. 12B is in a first configuration according to an embodiment of the present technology Fig. 12A A partially transparent isomorphic view of a fluid diversion device.

[0031] Fig. 12C Is in the first configuration Fig. 12BPartially transparent side view of a fluid diversion device.

[0032] Fig.12D Is in the first configuration Fig. 12B Partially transparent side view of a fluid diversion device.

[0033] Fig.12E is in a second configuration according to an embodiment of the present technology Fig. 12A A partially transparent isomorphic view of a fluid diversion device.

[0034] Fig.12F It is in the second configuration Fig.12E Partially transparent side view of a fluid diversion device.

[0035] Figure 12G It is in the second configuration Fig.12E Partially transparent side view of a fluid diversion device.

[0036] Fig.12H is in a third configuration according to an embodiment of the present technology Fig. 12A Partially transparent side view of a fluid diversion device.

[0037] Fig.12I is in the fourth configuration according to the second embodiment of the present technology Fig. 12A Partially transparent side view of a fluid diversion device. DETAILED DESCRIPTION

[0038] The present technology generally relates to fluid diversion devices and related methods for hydraulic delivery systems. Figures 1 to 12I Specific details of multiple embodiments of the present technology are described. Although many embodiments are described with respect to devices, systems, and methods for delivering artificial heart valve devices to a native mitral valve, other applications and other embodiments in addition to 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 artificial valves to other sites, such as a tricuspid valve or an aortic valve. In addition, the present technology can be used to deliver heart valve repair devices and / or other medical devices to target sites in the body. 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.

[0039] 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 an artificial 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 artificial valve devices described herein, "proximal" may refer to a position closer to an 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 an artificial 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).

[0040] Several embodiments of the present technology relate to a fluid shunt device for a delivery system of a mitral valve replacement device that addresses the unique challenges of percutaneous replacement of a native mitral valve and is well suited for being retracted in a percutaneous delivery device after being partially deployed to reposition or remove the device. Compared to replacing an aortic valve, percutaneous mitral valve replacement faces unique anatomical obstacles that make percutaneous mitral valve replacement 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 generally lacks symmetry. The complex and highly variable anatomy of the mitral valve makes it difficult to design a mitral valve prosthesis that is very conformal to the native mitral valve annulus of a particular patient. As a result, the prosthesis may not fit the native leaflets and / or annulus well, which may leave gaps that allow blood backflow to occur. For example, placing a cylindrical valve prosthesis in a native mitral valve may leave gaps in the commissure area of ​​the native valve, through which paravalvular leaks may occur.

[0041] The artificial valves currently developed for percutaneous aortic valve replacement are not suitable for use in mitral valves. First, many of these devices require a direct structural connection between a stent-like structure in contact with the ring and / or leaflet and the artificial valve. In multiple devices, the stent column supporting the artificial valve is also in contact with the ring or other surrounding tissues. These types of devices directly transmit the force applied by tissue and blood during heart contraction to the valve support and the artificial leaflet, and the force then causes the valve support to be distorted from its desired cylindrical shape. This is a problem worthy of attention, because most heart replacement devices use three leaflet valves, which require substantially symmetrical cylindrical supports around the artificial valve to allow the three leaflets to open and close normally within a few years of life. Therefore, when these devices are subjected to motion and force from the ring and other surrounding tissues, the prosthesis may be compressed and / or distorted, causing the prosthetic leaflet to malfunction. In addition, the diseased mitral valve ring is much larger than any available artificial aortic valve. 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.

[0042] In addition to having an irregular, complex shape that changes size during each heartbeat, the mitral valve annulus also lacks a significant amount of radial support from 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 only constrained by the muscle tissue on the outer wall. The inner wall of the mitral valve anatomy is constrained by the thin vascular 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 the expanded stent prosthesis) may cause the lower portion of the aortic tract to collapse. In addition, larger prostheses can exert greater forces and expand to larger sizes, which exacerbates this problem in mitral valve replacement applications.

[0043] The chordae tendineae of the left ventricle may also create obstacles when deploying a mitral valve prosthesis. Unlike the aortic valve, the mitral valve has a maze of cordage under the leaflets in the left ventricle that restricts movement and position of the deployment catheter and replacement device during implantation. Therefore, it is complicated to deploy, position, and anchor a valve replacement device on the ventricular side of the native mitral annulus.

[0044] 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 fluid diversion devices, such as an arrangement of multiple interconnected three-way stopcocks, which must be individually adjusted to the 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 fluid diversion devices physically and cognitively burdensome to clinicians, which increases the risks associated with the replacement procedure.

[0045] Embodiments of the present technology provide systems, methods, and apparatus for treating a body's heart valves, such as the mitral valve, that address challenges associated with the mitral valve anatomy and provide for repositioning and removal of valve replacement devices. The disclosed embodiments include a fluid shunt device that is capable of performing complex manipulations to flexibly place a valve replacement device at a target location in a timely manner by reducing the physical and cognitive burden of the clinician manipulating the fluid shunt device.

[0046] The disclosed embodiments overcome the aforementioned shortcomings of the fluid diversion device of the dual hydraulic delivery system, which can easily and reliably deploy and / or retract the valve replacement device. For example, the fluid diversion device of the disclosed embodiments can implement a cam mechanism that can rotate with the handle to switch between the deployed and retracted configurations. Therefore, the disclosed embodiments eliminate the need to arrange multiple interconnected three-way stopcocks, which saves clinician time by simplifying the operation for changing the delivery device from the deployed configuration to the retracted configuration (and vice versa).

[0047] The disclosed systems and methods achieve percutaneous access using intravascular delivery of a catheter through a vein or artery into the heart or by insertion of a cannula through the wall of the heart. For example, the systems and methods are particularly suitable for trans-septal and trans-apical approaches, but can also provide trans-atrial and direct aortic delivery of artificial replacement valves to a target location in the heart. In addition, 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.

[0048] The disclosed fluid shunt device helps to control the delivery of an artificial heart valve device using a transapical or transseptal delivery method, 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 fluid shunt device is connected to two fluid chambers, which are interchangeably filled with fluid and discharged to start the deployment and re-sheathing of the prosthetic device. This helps to deliver the hydraulic control and power of the proximal and distal movements of the capsule shell, which provides controlled delivery of the artificial heart valve device and inhibits the uncontrolled movement of the delivery system caused by the force (e.g., axial jump, self-ejection) associated with the expansion of the artificial heart valve device. In addition, the hydraulic delivery system disclosed herein can inhibit the longitudinal translation of the artificial heart valve device relative to the treatment site, while the artificial heart valve device moves between the containment configuration (i.e., fully retracted) and the deployment configuration. This enables clinicians to accurately position the sheathed artificial heart valve device at the desired target site for deployment, and then deploy the device at the target site without compensating for any axial movement caused by the deployment.

[0049] In order 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 for implanting the device. The mitral valve or other types of atrioventricular valves can be approached through the patient's vascular system in a percutaneous manner. Percutaneous means through the skin, usually using surgical incision or minimally invasive surgery (such as using a needle approach through, for example, the Seldinger technique) to approach the position of the vascular system away from the heart. The ability to percutaneously approach the distal vascular system is well known and described in patents and medical literature. Depending on the vascular access point, the 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, the 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, interventional tools and one or more support catheters can be advanced to the heart within the blood vessel and positioned adjacent to the target heart valve in various ways.

[0050] Figure 1 A stage of a transseptal approach for implanting a valve replacement device is shown. In the transseptal approach, 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 1As 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.

[0051] 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.

[0052] In an alternative antegrade approach (not shown), surgical access can be obtained through an intercostal incision (preferably without removing the ribs), 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.

[0053] As described above, an antegrade or trans-septal 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 a 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 a catheter or other interventional tool. 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, which cannot be traversed at all or without substantial risk of damage.

[0054] 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 through a traditional femoral artery approach or through a more direct approach through the brachial artery, axillary artery, radial artery or carotid artery. Such access can be achieved by 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 placing a guide catheter through an incision in the chest (preferably between the ribs without removing the ribs) and through a puncture in the aorta itself. The guide catheter 4 provides a subsequent access to allow placement of an artificial valve device, as described in more detail herein. Advantageously, the retrograde approach does not require a puncture through the septum. Cardiologists also use the retrograde approach more commonly, and therefore the retrograde approach is more well known.

[0055] Figure 5A 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 the puncture in the left ventricular wall. The catheter and prosthetic device of the present invention can then be introduced into the left ventricle through the 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.

[0056] During transcatheter heart valve replacement (e.g., delivered via a transfemoral or transapical approach), it is important to deploy the prosthetic heart valve device in a controlled and efficient manner in the correct target position relative to the native annulus, leaflets, left atrium, and left ventricular outflow tract (LVOT). For example, hydraulically controlled movement of the delivery capsule can reduce, limit, or substantially eliminate uncontrolled deployment of the prosthetic heart valve device caused by forces associated with the expanded heart valve device. The delivery system can also use hydraulically controlled movement to re-sheath a partially or fully expanded heart valve device to allow repositioning of the heart valve device relative to the natural anatomy and / or retraction of the device for removal from the body.

[0057] The fluid diversion devices described herein facilitate changing the deployment and retraction configurations in an efficient manner. For example, the disclosed fluid diversion device does not require physically manipulating multiple handles of multiple interconnected stopcocks in a complex manner, but instead requires less manual adjustment to change the direction of fluid flow within the delivery system and switch between deployment and retraction configurations. For example, in some embodiments, the fluid diversion device has a handle that can rotate a blocking mechanism to change the fluid diversion device between two positions, thereby initiating deployment or retraction of an artificial heart valve device. In this way, the disclosed device can simplify the process for performing complex operations to switch between deployment and retraction configurations, and improve the efficiency and ease of use of the delivery system.

[0058] Figure 61 is a partially schematic isometric view of a hydraulic delivery system 100 ("system 100") for deploying an artificial heart valve device 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 has a proximal portion 108a coupled to a handheld control unit 104 (e.g., a handle) and a distal portion 108b carrying the delivery capsule 106. The delivery capsule 106 can be configured to accommodate an artificial 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 artificial heart valve device 110 at the target site. The catheter 102 can be configured to travel on a guidewire 120, which can be used to guide the delivery capsule 106 into the native heart valve. The system 100 also includes a fluid diversion device 112 configured to supply a flowable substance (ie, hydraulic fluid, such as water or saline) to the catheter 102 and receive fluid from the catheter 102 to hydraulically move the delivery capsule 106 and deploy the prosthetic heart valve device 110 .

[0059] The control unit 104 may include a control assembly 122 and a steering mechanism 124. For example, the control assembly 122 may include a rotating element (such as a handle) that can be rotated to rotate the delivery capsule 106 around its longitudinal axis 107. The control assembly 122 may also include features that allow the clinician to control the hydraulic deployment mechanism of the delivery capsule 106 and / or the fluid diversion device 112. For example, the control assembly 122 may include a button, a handle, and / or other actuators that activate the unsheathing and / or re-sheathing of the artificial heart valve device 110. The steering mechanism 124 can be used to steer the catheter 102 through the anatomical structure by bending the distal portion 108b of the catheter body 108 around the transverse axis. In other embodiments, the control unit 104 may include additional and / or different features that facilitate delivery of the artificial heart valve device 110 to the target site.

[0060] The delivery capsule 106 includes a housing 126 configured to carry the prosthetic heart valve device 110 in a containment structure. The housing 126 can be made of one, two, or more components that at least partially enclose the prosthetic heart valve device 110 therein. The housing 126 can include a distal portion 128 that can have an opening 130 through which the guidewire 120 can pass to allow guidewire delivery to a target site. Figure 6As shown, the distal portion 128 may 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 a target site. The housing 126 may be made of metal, polymer, plastic, composite material, a combination thereof, or other material capable of holding the prosthetic heart valve device 110.

[0061] When the distal end portion 108b of the elongated catheter body 108 is delivered to the target location, the control unit 104 and / or the fluid diversion device 112 can be used to hydraulically drive the delivery capsule 106 from the containment configuration for holding the artificial heart valve device 110 toward the deployment configuration to partially or completely deploy and expand the artificial heart valve device 110 from the delivery capsule 106. For example, by supplying a flowable liquid to a chamber of the system 100 while also removing the flowable liquid from a separate chamber, the delivery capsule 106 can be hydraulically driven toward the deployment configuration. These fluid chambers can be located in the delivery capsule 106, along the elongated catheter body 108, in the handheld control unit 104, and / or elsewhere in the system 100. 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 caused by the forces associated with the expansion of the artificial heart valve device 110, such as jumping, self-ejection, and / or other types of uncontrolled movement. For example, the delivery capsule 106 is contemplated to inhibit or prevent translation of the prosthetic heart valve device 110 relative to the catheter body 108 when at least a portion of the prosthetic heart valve device 110 is expanded.

[0062] The catheter 102 is also configured to partially or completely re-sheath the artificial heart valve device 110 after partially deploying from the delivery capsule 106. For example, the delivery capsule 106 can be hydraulically driven back to the containment structure (e.g., retracted) by transferring fluid into one chamber and removing fluid from another chamber in a manner opposite to that used for deployment. The re-sheathing (also referred to herein as retraction) capability allows the clinician to reposition the artificial heart valve device 110 in vivo for re-deployment within the mitral valve MV, or to remove the artificial heart valve device 110 from the patient's body after partial deployment. After the artificial heart valve device 110 is fully deployed, the delivery capsule 106 and the catheter 102 can be pulled proximally by the guide catheter for removal from the patient. After the catheter 102 is removed, the catheter can be cleaned and used to deliver additional prosthetic devices, or the catheter can be discarded.

[0063] The fluid diversion device 112 is fluidically coupled to the catheter 102 via a fluid line 116. The fluid diversion device 112 is also fluidically coupled to one or more reservoirs 114 (identified as a first reservoir 114a and a second reservoir 114b), which may contain a flowable substance (e.g., water, saline) that is used to hydraulically drive the positioning of the artificial heart valve device 110 by controlling the flow of fluid into a chamber while removing fluid from another chamber of the system 100. The reservoir 114 may include an inflation device with a pressurized fluid and a discharge device configured to receive the discharged fluid. The fluid diversion device 112 may include one or more hoses, pipes, or other components (e.g., fittings, connectors, valves) through which fluid can flow from the reservoir to the catheter 102, and / or through which fluid can be discharged from the catheter 102 to the reservoir.

[0064] In some embodiments, the fluid line 116 can deliver fluid from the second reservoir 114b to the catheter 102 via the fluid diverter 112. The fluid line 116 can also discharge fluid from the catheter 102 to the first reservoir 114a via the fluid diverter 112. In some embodiments, the fluid source can include one or more pressurizing devices (e.g., an inflator, a pump) that are fluidically coupled to the fluid diverter 112, which can also include one or more fluid connectors, fittings, valves, and / or other fluid components that help move fluid to and / or from the fluid reservoir 114. The movement of fluid into and out of the fluid diverter 112 can be used to deploy the artificial heart valve device 110 from the delivery capsule 106 and / or re-sheath the artificial heart valve device 110 after at least partial deployment.

[0065] As explained in more detail below, the fluid diversion device 112 includes a flow control assembly that controls the flow of fluid into and out of the catheter 102. In some embodiments, the flow control assembly can be placed in an elongated hole (e.g., a hole) extending through the fluid diversion device housing and includes one or more cams that can change the direction of fluid flow based on the rotation of the flow control assembly. Further, the fluid diversion device 112 can include an actuator, such as a handle 118, that allows a clinician to control the deployment or re-sheathing of the artificial heart valve device 110 by rotating the cam. The handle 118 can be rotated so that the cam blocks different tubes depending on the rotation angle of the handle 118. Specifically, multiple tubes can pass through the cam so that the rotation of the cam can block the flow of fluid through the first set of tubes while keeping the second set of tubes open. The handle 118 can be rotated again to rotate the cam so that the flow of fluid through the second set of tubes is blocked, while the first set of tubes is opened. This blocking and opening of a specific tube extending through the fluid diversion device 112 can initiate fluid flow in the opposite direction to achieve deployment and re-sheathing.

[0066] In some embodiments, the fluid diversion device 112 is coupled 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 for controlling the flow of fluid into and out of the reservoir 114.

[0067] Fig. 7A and Figure 7B is in a containing configuration ( Fig. 7A ) and expansion configuration ( Figure 7B )of Figure 6 An enlarged partial cross-sectional view of the system 100 is shown. Fig. 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 referred to as "chambers 144"). The first chamber 144a and the second chamber 144b are fluid-tightly sealed to each other and to a compartment 146 in the housing 126, which is configured to accommodate at least a portion of the prosthetic heart valve device 110. The chamber 144 can be filled and emptied to adjust the position of the prosthetic heart valve device 110 in a contained configuration ( Fig. 7A ) and a deployment configuration for at least partially deploying the prosthetic heart valve device 110 ( Figure 7B ) between the delivery capsule 106. In some embodiments, the chambers 144 can be included in a combination of the catheter body 108 and / or the handheld control unit 104. For example, the deployment chamber 144a can be located within the delivery capsule 106, while the retraction chamber 144b can be located along the catheter body 108 and / or within the handheld control unit 104.

[0068] like Fig. 7AAs shown, the housing 126 of the delivery capsule 106 is proximally (in the direction of arrow 153) pushed toward the deployed configuration 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 proximal translation of the housing 126 allows the prosthetic heart valve device 110 to be at least partially deployed from the housing 126 ( Figure 7B ) and expands so that it can engage the surrounding tissue of the native mitral valve. Figure 7B As shown, when fluid is at least partially discharged 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.

[0069] 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 a part of the housing 126, such as an inwardly extending flange. Therefore, the platform 142 can be made of the same material as the housing 126 (e.g., metal, polymer, plastic, composite material, a combination thereof). In other embodiments, the platform 142 can be a separate component that at least partially separates the two chambers 144 from each other.

[0070] like Fig. 7A and 7B As shown, the fluid delivery shaft 148 extends through the catheter body 108, into the housing 126 of the delivery capsule 106 and through the platform 142. At its proximal end (not shown), the shaft 148 is connected to the fluid diversion device 112 and includes one or more fluid pipelines 152 (individually identified as a first pipeline 152a and a second pipeline 152b) that can deliver and / or discharge fluid to and / or from the chamber 144. The fluid pipeline 152 can be a fluid passage or lumen formed integrally in the shaft 148, such as a channel passing through the shaft itself, or the fluid pipeline 152 can be a tube or hose positioned in one or more hollow regions of the shaft 148. The first pipeline 152a is in fluid communication with the first chamber 144a through a first opening 166a in the first fluid pipeline 152a, and the second pipeline 152b is in fluid communication with the second chamber 144b through a second opening 166b in the second fluid pipeline 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.

[0071] 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 a distal end by a proximally facing surface of the platform 142, at a proximal end by a distally facing surface of the first flange 154a, and by an inner wall of the housing 126 extending therebetween.

[0072] The second chamber 144b is defined at the proximal end by the distally 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 artificial heart valve device 110 can be defined by the distally facing surface of the second flange 154b, the end cap 128, and the inner wall of the housing 126 extending therebetween. The shaft 148 and the flange 154 can be integrally formed or separate components and can be made of metal, polymer, plastic, composite material, a combination thereof, and / or other suitable materials for containing fluids. The flange 148 is fixed relative to the shaft 148. Sealing members 156 (individually identified as first to third sealing members 156a-c), such as O-rings, can be positioned around or within the flange 154 and / or the platform 142 to fluidly seal the chambers 144a-b from the rest of the delivery capsule 106. For example, first and second sealing members 156a, 156b may be positioned in recesses of corresponding first and second flanges 154a, 154b to fluidly seal flanges 154 to the inner wall of housing 126, and third sealing member 156c may be positioned in a recess of platform 142 to fluidly seal platform 142 to shaft 148. In other embodiments, system 100 may include additional and / or differently arranged sealing members to fluidly seal chamber 144.

[0073] The fluid line 152 is in fluid communication with the fluid diversion device 112 at the proximal portion of the system 100. The fluid diversion device 112 has a housing 180 that includes a passage (not shown) that passes through a coupling structure 184 (e.g., an aperture). The housing 180 also includes tubes 182a-d that are disposed in the passage and coupled to fittings 186 (individually identified as fittings 186a-d) for the tubes 182a-d that pass through the coupling structure 184. The fluid diversion device 112 includes a flow control assembly 188 (e.g., a shaft) that includes one or more cams disposed at the coupling structure 184. The flow control assembly 188 is rotatably movable to control fluid flow by blocking some of the tubes 182a-d and leaving other tubes open. The fluid diversion device 112 can include a handle 190 that is operably coupled to move the flow control assembly 188 between a first position (e.g., a contained or retracted configuration) and a second position (e.g., a deployed configuration) to selectively allow fluid to flow to the first chamber and drain fluid from the second chamber, and vice versa. By rotating the handle 190 between the two positions, the flow control assembly 188 can adjust the flow of fluid into and out of the chamber 144.

[0074] like Fig. 7A As shown, when the flow control assembly 188 of the fluid diversion device 112 is placed in the first position (for example, by the handle 190), the flow control assembly 188 defines the selected fluid path through a plurality of tubes 182 (referred to individually as the first to fourth tubes 182) to start the device to unfold. For example, in the first position, the first tube 182a is opened to allow the fluid to flow to the second chamber 144b of the system 100 through the fittings 186c and 186a, and the second tube 182b is also opened to discharge the fluid from the first chamber 144a, while the tube 182b allows the fluid to flow to the second chamber 144b. In addition, the flow control assembly 188 can block the third tube 182c and the fourth tube 182d by one or more cams (not shown) to prevent the fluid from flowing through. The simultaneous or concurrent fluid delivery and removal via the first tube 182a and the second tube 182b causes the delivery system 100 to move from the containment configuration to the unfolding configuration to at least partially unfold the artificial heart valve device 110 from the delivery capsule 106.

[0075] like Figure 7B As shown, when the flow control assembly 188 is moved to the second position (via the handle 190), the cam rotates so that the third tube 182c opens to allow fluid to be discharged from the second chamber 144b, and the fourth tube 182d opens to allow fluid to flow to the first chamber 144a through the fittings 186d and 186b. This simultaneous movement of fluid from the chamber 144 moves the delivery system 100 from the deployed or partially deployed configuration to the contained configuration, thereby enabling the retraction of the artificial heart valve device 110.

[0076] Thus, movement of the fluid control assembly 188 between the first position and the second position causes the openings 185 (individually identified as first to fourth openings 185a-d) and associated fittings 186 of the fluid diversion device 112 to alternately function as outlets and inlets, depending on whether the delivery system 100 is moving toward a deployed configuration for unsheathing the prosthetic heart valve device 110 or toward a contained configuration for resheathing the prosthetic heart valve device 110. For example, in the illustrated embodiment, 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 device deployment, and function as an inlet when the flow control assembly 188 is in the second position for device retraction or system removal. 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 the second opening and second fitting function 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 position or the second position, to provide a consistent fluid discharge site, 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 diversion 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 the change in the position of the fluid control assembly 188.

[0077] 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 ( Fig. 7A). To fully 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 tube 182a, through the first fitting 186a (as shown by arrow 157), to the second fluid line 152b and into 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 shown by arrow 159) through the first fluid line 152a and through the second tube 182b. In some embodiments, the fluid is transferred to the second chamber 144b and transferred 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 chamber. This concurrent fluid transfer between chambers 144 drives housing 126 proximally in the direction of arrow 153 to deploy prosthetic heart valve device 110. In other embodiments, such as when one or both of chambers 144 are distal to compartment 146 housing prosthetic heart valve device 110, deployment may be accomplished by moving delivery capsule 106 in a distal direction.

[0078] exist Figure 7BIn the deployed configuration, the delivery capsule 106 axially restricts the outflow portion of the artificial heart valve device 110, while the inflow portion of the artificial heart valve device 110 is deployed from the delivery capsule 106. After at least partially deploying, the fluid chamber 144 can be pressurized and discharged in the opposite manner to move the housing 126 back to the containment configuration distally (in the direction of arrow 155) and at least partially re-sheath the artificial heart valve device 110. In order to re-sheath, the handle 190 is manipulated to move the flow control assembly 188 to the second position. This allows the fluid to be discharged from the second chamber 144b, through the second fluid line 152b, into the fitting 186a (as shown by arrow 161), and along the third fluid tube 182c. When the fluid leaves the second chamber 144b, the fluid is also delivered to the first chamber 144a via the second fitting 186b and delivered to the first fluid line 152a (as shown by arrow 163). Likewise, fluid may be transferred from both chambers 144 simultaneously and / or in equal proportions. This transfer of fluid into the first chamber 144a and out of the second chamber 144b drives the housing 126 distally in the direction of arrow 155 to controllably re-sheath the prosthetic heart valve device 110 so that at least a portion of the prosthetic heart valve device 110 is positioned again within the compartment 146. This partial or complete re-sheathing of the prosthetic heart valve device 110 enables a clinician to reposition or remove the prosthetic heart valve device 110 after partial deployment. The hydraulic movement of the housing 126 may provide controlled deployment and re-sheathing of the prosthetic heart valve device 110. In other embodiments, for example when one or both chambers 144 are located distal to the compartment 146 housing the prosthetic heart valve device 110, re-sheathing may be performed by moving the delivery capsule 106 in a proximal direction.

[0079] When 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 ( Fig. 7A ) and expansion 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 compensating for any axial movement of the device 110 when it reaches full expansion (e.g., this would need to be taken into account if the device 110 was pushed distally from the housing 126).

[0080] like Fig. 7A and 7BAs 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 located within the distal portion 108b of the catheter body 108, but in other embodiments, the biasing device 168 can be located in other parts of the system 100, such as the handheld control unit 104 ( Figure 6 ). The biasing device 168 can be a spring or other feature that pushes the housing 126 and / or other portions of the delivery capsule 106 toward the containment structure. The biasing device 168 limits or substantially prevents the opening of the delivery capsule 106 due to the force 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.

[0081] Figure 8 A fluid diversion device configured according to an embodiment of the present technology (e.g., Figure 6-7B An isometric view of a fluid diversion device housing 200 ("housing 200") of a fluid diversion device 112 of the present invention. The housing 200 includes a plurality of channels 202 (individually identified as first to fourth channels 202a-d) and a joining structure 204 extending laterally through the channels 202. The joining structure 204 can be defined by an inner surface or wall of the housing 200 that forms a hole (e.g., a bore) and / or a separate open tube or structure extending through a portion of the housing 200. Thus, the channel 202 passes through the joining structure 204 from a first side 206a of the housing 200 to a second side 206b of the housing 200. The housing 200 can integrate components to collectively form a fluid diversion device for controlling delivery of fluid through a delivery system (e.g., Figures 6 to 7B delivery system 100) to deploy and / or retract a prosthetic heart valve device (e.g., Figures 6 to 7BThe housing 200 may also include one or more connection structures 208 (individually identified as first and second connection structures 208a-b), such as a stent, which may receive and / or otherwise secure to another portion of the delivery system, such as an inflation device that contains a fluid that is pressurized to flow to a selected chamber of the delivery system. In some embodiments, the connection structure 208 may be secured to other features of the delivery system (e.g., other fluid reservoirs, a handheld controller ( Figure 6 )) and / or a structure separate from the delivery system (e.g., an operating table, a device holding tray, a support rod).

[0082] Fig. 9A is a heterogeneous view of a fluid flow diversion device 210 configured according to an embodiment of the present technology, the fluid flow diversion device comprising Figure 8 The housing 200 and associated fluid lines or tubes 212 (individually identified as first to fourth tubes 212a-d). Fig. 9A As shown, the channel 202 of the housing 200 receives the tube 212 so that the tube 212 extends from the first side 206a of the housing 200 through the engagement structure 204 to the second side 206b. The flow control assembly 214 is disposed in the engagement structure 204 and includes one or more blocking members, such as one or more cams 216 (hereinafter referred to as Fig. 9C Detailed further), the cam can selectively close or open the tube set 212 depending on the rotational position of the blocking member. In the illustrated embodiment, the ends of at least some of the tubes 212 are coupled to fittings 220a and 220d, which provide connections to additional fluid lines and / or other components associated with the delivery system. In these and other embodiments, the tubes 212 can be connected to other components, such as connectors, valves, reservoirs, pumps, other tubes, conduits, and / or other components associated with the hydraulic delivery system.

[0083] The fluid diversion device 210 may also include an actuator 218 operably coupled to the flow control assembly 214. Fig. 9AIn the illustrated embodiment, the actuator 218 is a rotatable handle that can be manipulated to rotate the flow control assembly 214 to the deployed position, the restored position, and / or other positions. Thus, the rotation of the handle causes the blocking member 216 to be selectively positioned in at least a first position and a second position, the first position blocking a first subset of the tube 212, and the second position blocking a second subset of the tube 212, for fluid communication in different directions relative to a first chamber (e.g., a deployment chamber) and a second chamber (e.g., a re-sheathing chamber) of the delivery system, so as to facilitate the deployment and retraction of the artificial heart valve device. Thus, the handle can be rotated between at least two positions (e.g., 180 degrees between the first position and the second position) to change the direction of fluid flow relative to the delivery system chamber connected to the fluid diversion device 210. In other embodiments, the actuator 218 can be a button, a switch, a dial, and / or other components that are operably connected to the flow control assembly 214 and actuated by a user (e.g., a clinician) to adjust the position of the flow control assembly 214. Further, actuator 218 may be configured to withstand mechanical loads applied by a clinician to change the position of flow control assembly 214 while providing mechanical stability and reduced friction to reduce the overall effort required to change the direction of fluid flow.

[0084] During operation, fluid can be drawn from a reservoir (e.g., Figure 6 114) through a selected set of tubes 212 to a delivery catheter (e.g., Figure 6 The first and fourth tubes 212a, 212d may be coupled to a discharge port that receives fluid from a delivery system, and the second and third tubes 212b, 212c may be coupled to an inflation device (e.g., an inflator) or other reservoir containing pressurized fluid that may be delivered to a chamber of the delivery system.

[0085] The fluid diversion device 210 can be made of a variety of materials. For example, the housing 200, the flow control assembly 214, the handle 218 and / or the fitting 220 can be made of mechanically strong materials, such as rigid polymers, metals, alloys, etc. The tube 212 can be made of various mechanically strong but compressible materials, such as flexible polymers. The diameters of the channel 202 of the housing 200 and / or the tube 212 contained therein can be selected so that they facilitate delivery of fluid at a suitable pressure and velocity to the delivery catheter.

[0086] Fig. 9B and Fig. 9C are respectively in a first state or configuration according to an embodiment of the present technology Fig. 9A The top view and side view of the fluid diversion device 210 are shown. Fig. 9B and Fig. 9CAs shown, when the passage 202 extends through the housing 200, the flow control assembly 214 and the portion of the joint structure 204 through which the flow control assembly 214 extends, the passages can be arranged at least substantially parallel to each other. The tube 212 is disposed in the passage 202 and is coupled to fittings 222 (individually identified as first to fourth fittings 222a-d) that define an inlet and / or an outlet of the fluid diversion device 210. Fig. 9C As further shown, the fluid control assembly 214 can include one or more blocking members, such as cams 216 (individually identified as first to fourth cams 216a-d). In the illustrated embodiment, the fluid control assembly 214 includes four cams 216, but in other embodiments, the fluid control assembly 214 can include one, two, three, or more than four cams 216 or other blocking members for selectively opening and closing the tube 212. The cams 216 can include a separation structure that separates the tube 212 so that the tube 212 remains aligned with the channel 202. Although the multiple cams 216 are rotationally offset from adjacent cams, they can be aligned with each other to provide selective blocking of the tube based on the rotation of the fluid control assembly 214. In some embodiments, for example, the first cam 216a and the third cam 216c can define a first cam subset that is rotationally aligned with each other, and the second cam 216b and the fourth cam 216d can define a second cam subset that is rotationally offset from the first cam subset. During use, a user may rotate or otherwise manipulate actuator 218 , which in turn rotates fluid control assembly 214 about its longitudinal axis, thereby moving cams 216 (via actuator 218 ) such that a subset of cams 216 selectively blocks and / or opens a corresponding subset of tubes 212 .

[0087] When the fluid diversion device 210 is in Fig. 9B and Fig. 9C In the deployed configuration shown, the flow control assembly 214 is moved to a first position by rotation of the actuator 218. In the first position, the rotational position of the flow control assembly 214 relative to the channel 202 causes a first subset of the cams 216 (the first cam 216a and the third cam 216c) to open the first tube 212a and the third tube 212c while clamping the second tube 212b and the fourth tube 212d closed. Thus, in the first position, the cams 216 block the second tube 212b and the fourth tube 212d to prevent fluid flow and allow the first tube 212a and the third tube 212c to remain open and allow fluid to flow. In this first position, the cams 216 of the fluid diverter device 210 form an open fluid path through the third tube 212c, which allows fluid to flow from the fluid reservoir (e.g., the inflation device), through the fourth fitting 222d, through the fluid diverter device housing 200, through the second fitting 222b on the opposite side of the housing 200, and into the chamber of the delivery catheter (e.g., the deployment chamber, Fig. 7APositioning the cam 216 of the fluid diverter device 210 in the first position also forms an open fluid path through the first tube 212a, which allows fluid to be transferred from another chamber of the delivery catheter (e.g., the re-sheath chamber, Fig. 7A The fluid diverter device 210 can provide for simultaneous delivery and removal of fluid from two chambers of the delivery system, which together result in unsheathing and deployment of the prosthetic heart valve device.

[0088] After the prosthetic heart valve device is at least partially deployed, the user can rotate actuator 218 (e.g., 180 degrees) to move flow control assembly 214 to a second position, thereby allowing retraction (i.e., re-sheathing) of the prosthetic heart valve device and / or closure of the delivery capsule. Fig.9D and Fig.9E are respectively in a second state or configuration according to an embodiment of the present technology Fig. 9A 2 and 3. In this second configuration, the flow control assembly 214 is rotated relative to the passage 202 to a second position, which causes the first cam subset 216 to clamp or otherwise block the first tube 212a and the third tube 212c, while the second cam subset 216 allows fluid to flow through the second tube 212b and the fourth tube 212d.

[0089] In the second position, the cam 216 forms an open fluid path through the second tube 212b, which allows fluid to flow from the fluid reservoir (e.g., an inflation device), through the fourth fitting 222d, through the housing 200, through the first fitting 222a, and into the resheath chamber of the delivery catheter (e.g., Fig. 7A 212a). Positioning the cam 216 of the fluid diverter device 210 in the segmented position also forms an open fluid path through the fourth tube 212d, which allows fluid to flow from the deployment chamber, through the second fitting 222, through the housing 200, through the third fitting 222c and into a drain or other reservoir for receiving fluid. Thus, in operation, re-sheathing or closing of the delivery capsule occurs by delivering fluid to the re-sheathing chamber via the second tube 212b while expelling fluid from the deployment chamber via the fourth tube 212d.

[0090] exist 9A to 9EIn the illustrated embodiment, the second tube 212b and the third tube 212c are used as a fluid delivery path extending to the deployment chamber or the retraction chamber of the delivery catheter (depending on the position of the fluid control assembly 214), and the fourth fitting 222d connected to the second tube 212b and the third tube 212c is used as the inlet of the fluid delivery path. This is true when the fluid control assembly 214 is rotated to the first position or the second position, so the fourth fitting 222d and the second tube 212b and the third tube 212c can be connected to a fluid supply reservoir (e.g., an inflatable device) to provide fluid to the delivery system chamber. Similarly, the first tube 212a and the fourth tube 212d can be used as a fluid removal path extending away from the deployment chamber or the retraction chamber of the delivery catheter, and the third fitting 222c connected thereto can be used as the outlet of the fluid removal path, regardless of the position of the flow control assembly 214. Thus, the third fitting 222c and the first and fourth tubes 212a, 212d may be coupled to a drain reservoir that receives fluid removed from the delivery system chamber or an opening that allows fluid to flow out of the delivery system.

[0091] like FIG. 9B to FIG. 9E As further shown in FIG. 1 , a first fitting 222a can be coupled to two tubes 212a, 212b in fluid communication with the re-sheathing chamber such that the first fitting forms an inlet through the first tube 212a or an outlet through the second tube 212b, depending on whether the flow control assembly 214 is in the first position or the second position. Similarly, a second fitting 222b can be coupled to two tubes 212c, 212d in fluid communication with the deployment chamber such that the second fitting 222b forms an inlet through the fourth tube 212d or an outlet through the third tube 212c, depending on whether the flow control assembly 214 is in the first position or the second position.

[0092] Although the fittings 222 and tubes 212 are described in terms of certain fluid directions through the fluid diversion device 210 based on the position of the fluid control assembly 214, those skilled in the art will appreciate that this is a relative arrangement that can be achieved with different assembly arrangements. For example, the description of the fluid flow of the fluid diversion device 210 can be changed by swapping the connection between the two fluid chambers delivered, such that, for example, when the flow control device 210 is in the first position, the retraction chamber is filled and the deployment chamber is exhausted. In addition, although the fluid diversion device 210 is shown as having four tubes 212 disposed in four channels 202, other embodiments may include fewer than four or more than four tubes 212 and / or channels 202.

[0093] Fig. 10A and Fig. 10B A process for attaching an inflatable device 224 (eg, an inflator) to a housing 200 of a fluid diversion device 210 is shown in accordance with an embodiment of the present technology. Fig. 10AAs shown, the first support structure 208a and the second support structure 208b extending from the housing 200 can receive the ends of the inflatable device 224 (as shown by the arrows). Fig. 10B As shown, the inflatable device 224 can cooperate with the complementary or interlocking surface of the support structure 208 to physically fix the inflatable device 224 to the housing 200 during operation of the fluid diversion device 210. In some embodiments, the support structure 208 can include a knob that can be rotated or otherwise actuated to clamp the support structure 208 and / or another fixing feature (e.g., a bolt) to the inflatable device 224, thereby physically fixing the two components together. In some embodiments, the fluid diversion device 210 can include additional or alternative connectors to fix the housing 200 to the inflatable device 224.

[0094] Fig.11A and Fig. 11B 2 are front and rear isometric views of a fluid diversion device housing 250 ("housing 250") configured in accordance with an embodiment of the present technology. Housing 250 may include the same Figures 8 to 10B The housing 250 may include certain features that are substantially similar to the housing 200 described above. For example, the housing 250 includes a plurality of channels 252 (individually identified as first through fourth channels 252a-d) extending between a first side 256a and a second side 256b of the housing 250, a connecting structure 254 (e.g., an elongated hole, a hole) extending laterally through the channels 252, and a support structure 258 (individually identified as a first support structure 258a and a second support structure 258b) that can releasably secure the housing 250 to an inflation device (e.g., an inflator) and / or other structures associated with the delivery system. Fig.11A and Fig. 11B In the illustrated embodiment, the channels 252 are arranged to form two subsets of two rows of channels 252: a first channel subset 252 including a first channel 252a and a second channel 252b, and a second channel subset 252 including a third channel 252c and a fourth channel 252d. Fig. 12B As further described, the channels 252 in each subset are arranged parallel to each other, but not necessarily parallel to the channels 252 in another subset. For example, a first subset of channels 252 can extend diagonally upward from a first side 256a of the housing 250 to a second side 256b, and a second subset of channels 252 can extend diagonally downward from the first side 256a to the second side 256b, or vice versa. The housing 250 can integrate various components to collectively form a fluid diversion device that is operable to control a delivery system (e.g., Figures 6 to 7B The invention relates to a delivery system 100 for controlling the flow of fluid in the delivery system 100 to deploy or retract the artificial heart valve device.

[0095] like Fig. 11BAs shown, the housing 250 may further include a plurality of rails 261 (individually identified as a first rail 261a and a second rail 261b), which terminate at one or more grooves or notches 260 (individually identified as first to third notches 260a-c). The notches 260 are configured to support a portion of a handle actuator (not shown) of the fluid diversion device at a plurality of rotational offset positions (e.g., two or three different positions), and each position rotational offset position defined by the notches 260 may correspond to a different mode of the fluid diversion device (e.g., an expanded mode, a retracted mode, and a neutral mode). For example, placing the handle actuator on the first notch 260a may set the fluid diversion device to a retracted configuration, placing the handle actuator on the second notch 260b may set the fluid diversion device to a neutral configuration, and placing the handle actuator on the third notch 260c may set the fluid diversion device to an expanded configuration.

[0096] Fig. 12A It is a configuration according to an embodiment of the present technology Fig.11A and Fig. 11B An isometric view of the fluid diversion device 268 of the housing 250, Fig. 12B It is a display Fig. 12A A partially transparent isometric view of the internal features of the fluid diversion device of FIG. 268 can include various features that are generally similar to those described above with reference to FIG. 9A to 10B For example, the fluid diversion device 268 includes a plurality of fluid lines or tubes 270 (individually identified as first to fourth tubes 270a-d) received in respective channels 252, a flow control assembly 272 ( Fig. 11B ), and a handle actuator 274 coupled to the flow control assembly 272. The tube 270 may include or be coupled to an accessory (e.g., FIG. 9B to FIG. 9E The fitting 222 forms an inlet and / or an outlet of a fluid diversion device 268 to deliver fluid to a delivery conduit (e.g., Figure 6 A to Figure 7B The deployment chamber and the retrieval chamber of the delivery catheter device) / delivering fluid from the deployment chamber and the retrieval chamber of the delivery catheter.

[0097] In operation, the fluid diverter device 268 can alternately block the flow of fluid through the tube set 270 while simultaneously controlling the flow of fluid through the tube set 270 in a manner similar to that described above with reference to 9A to 9E The flow control assembly 272 is rotated in a manner similar to the fluid diversion device 210 described above to allow fluid to flow through another tube set 270. For example, the handle actuator 274 can be rotated between at least two positions to change the direction of fluid flow relative to the two chambers of the delivery catheter coupled to the fluid diversion device 268. However, unlike 9A to 9EThe fluid flow dividing device 210 is different from the fluid flow dividing device 210, which includes a plurality of cams that selectively act on a tube set 212 arranged in parallel. Fig. 12A The fluid control assembly 272 of the illustrated fluid diverter device 268 includes a single cam that acts on a tube disposed on opposite sides of the cam 276 .

[0098] Cam 276( Fig. 12B ) can close and open the tube set 270 by rotating the flow control assembly 272 to a first position and a second position. For example, moving the handle actuator 274 to the third notch 260c causes the flow control assembly 272 to rotate to the first position. In the first position, the flow control assembly 272 blocks the flow of fluid through the first tube 270a and the second tube 270b, while allowing the flow of fluid through the third tube 270c and the fourth tube 270d. Moving the handle actuator 274 to the first notch 260a causes the flow control assembly 272 to reach the second position, in which the cam 276 blocks the flow of fluid through the third tube 270c and the fourth tube 270d, and allows the flow of fluid through the first tube 270a and the second tube 270b. Therefore, by rotating the fluid control assembly 272 to the first position or the second position, respectively, the fluid diversion device 268 can be switched between a first configuration (e.g., an expanded configuration) and a second configuration (e.g., a retracted configuration).

[0099] FIG. 12B to FIG. 12D are in a first state or configuration (e.g., an expanded configuration) respectively Fig. 12A A partially transparent isometric view, a rear view and a side view of a fluid diversion device 268, FIG. 12E to FIG. 12G are in a second state or configuration (e.g., a retracted configuration) Fig. 12A A partially transparent isometric view, a rear view, and a side view of the fluid diversion device 268. FIG. 12B to FIG. 12D In the first state shown, the fluid control assembly 272 is in a first position such that the first channel 252a and the second channel 252b (i.e., the first channel subset 252) are blocked by the cam 276 to prevent fluid from flowing through the first tube 270a and the second tube 270b, while the third channel 252c and the fourth channel 252d are opened to allow fluid to flow through the third tube 270c and the fourth tube 270d. The third tube 270c and the fourth tube 270d can define a fluid path between a fluid reservoir (e.g., an inflator) and the deployment chamber and a second fluid path between the re-sheathing chamber and the fluid discharge port. Therefore, when the fluid control assembly 272 is in the first position, the fluid can be delivered to the deployment chamber via the third tube or the fourth tube 270c, d and the channel 252c, d, while the fluid is discharged from the re-sheathing chamber through the other of the tubes 270c, d and the channels 252c, d. As shown in FIG. Fig.12DAs shown, the cam 276 may also include structures, such as protrusions, to align the tubes 270 with the channels 252 and to separate the tubes 270 from each other.

[0100] To change the fluid diversion device 268 to Figures 12E to 12G In the second state shown, the user can rotate the handle actuator 274 by a predetermined amount (e.g., 180 degrees) so that the handle actuator 274 is supported by the first notch 260a. This rotation of the handle actuator 274 rotates the fluid control assembly 272 to a second position, in which the cam 276 opens the first channel 252a and the second channel 252b to allow fluid to flow through the first tube 270a and the second tube 270b, while blocking the third channel 252c and the fourth channel 252d to prevent fluid from flowing through the third channel 270c and the fourth channel 270d. The first tube 270a and the second tube 270b can form a fluid path between a fluid reservoir (e.g., an inflator) and the re-sheathing chamber, and form a second fluid path between the deployment chamber and the fluid discharge port. Thus, when the fluid control assembly 272 is in the second position, fluid can be delivered to the re-sheathing chamber via the first or second tube 270a, b and the channel 252a, b, while fluid is discharged from the deployment chamber through the other of the tube 270a, b and the channel 252a, b. Thus, the clinician can change the position of the fluid control assembly 272 by rotating the handle actuator 274 to form a combination of different fluid paths through the tube 270 based on the rotational position of the fluid control assembly 272.

[0101] The fluid diversion device 268 may optionally include one or more additional or other configurations beyond the deployed configuration and the retracted configuration. For example, Fig.12H is in a third state or configuration according to an embodiment of the present technology Fig. 12A 260a. A partially transparent rear view of the fluid diversion device 268 of FIG. 260b. The third configuration can be a neutral configuration in which the flow control assembly 272 is rotated a predetermined degree of rotation (e.g., 90 degrees counterclockwise) from the deployed configuration. For example, a portion of the handle actuator 274 can abut the second notch 260b to position the flow control assembly 272 in a third position corresponding to the neutral configuration of the device 268. In this neutral mode, the cam 276 can partially compress all tubes 270 to allow flushing of all tubes 270 (e.g., prior to a delivery process). In some embodiments, once the device 268 has been moved from this configuration to avoid this configuration during device delivery, the arrangement of the guide rails 261 and / or other features of the fluid diversion device 268 prevent the flow control assembly 272 from returning to this neutral configuration during operation.

[0102] Fig.12I is in a fourth state or configuration according to an embodiment of the present technology Fig. 12AA partially transparent rear view of the fluid diversion device 268 of FIG. 4 can be used as a switching mode, wherein the flow control assembly 272 is rotated from the first state (e.g., the deployed mode) to the second state (e.g., the retracted mode) by a predetermined rotation degree (e.g., 90 degrees clockwise). During the switching, all of the tubes 270 can be compressed, which results in a reduced pressure drop when changing between the deployed configuration and the recovered configuration.

[0103] Although described in terms of a configuration in which the fluid flow diversion device has an inlet and an outlet to pass 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 can be changed by swapping the connection between the two chambers so that, for example, when the flow control assembly is in the first position, the second chamber is filled and the first chamber is exhausted. In addition, although four tubes are shown disposed in four channels, other embodiments may include more or fewer tubes or channels arranged in other directions.

[0104] Although described with reference to applications involving implantation of artificial valve devices, the disclosed embodiments are not limited thereto. Figures 6 to 12I The disclosed embodiments of the described fluid shunt devices can be configured to deliver various other medical devices in addition to, or in lieu of, artificial valve devices for replacing the mitral valve and / or other valves in the patient's heart. The specific elements, substructures, advantages, uses, and / or other features described herein can be appropriately interchanged, replaced, or otherwise configured to include one another. In addition, appropriate elements of the described embodiments can be used as stand-alone devices and / or self-contained devices.

[0105] From the above, it will be appreciated that, for the purpose of illustration, specific embodiments of the present invention have been described herein, but various modifications may be made without departing from the scope of the present invention. Therefore, the present invention is not limited except by the appended claims.

Claims

1. A fluid diversion device for controlling fluid flow in a delivery system to deploy an artificial heart valve device, the fluid diversion device comprising: a housing comprising a first side, a second side, an aperture, and a plurality of passages through the housing from the first side through the aperture to the second side, wherein the plurality of passages are configured to receive a corresponding plurality of tubes extending from the first side of the housing through the aperture to the second side, and wherein the aperture extends transversely through the plurality of passages; a blocking member disposed in the bore, wherein rotation of the blocking member enables selective blocking of a first set of tubes or a second set of tubes disposed in the plurality of channels; and An actuator operably connected to the blocking member to enable the blocking member to be selectively positioned in at least a first position and a second position, the first position blocking the first tube set and the second position blocking the second tube set, for fluid communication in different directions relative to the first chamber and the second chamber of the delivery device to cause deployment and retraction of the artificial heart valve device.

2. The fluid flow dividing device according to claim 1, wherein: When the blocking member is in the second position, the first set of tubes is opened and the second set of tubes is blocked to allow fluid to drain from the first chamber and to allow fluid to flow to the second chamber.

3. The fluid flow dividing device according to claim 2, wherein: When the blocking member is in the first position, the first set of tubes is blocked and the second set of tubes is opened to allow fluid to flow to the first chamber and to allow fluid to be discharged from the second chamber.

4. The fluid flow dividing device according to claim 3, wherein: The delivery system is configured to cause deployment of the prosthetic heart valve device when the occlusion member is in the first position, and is configured to cause retraction of the prosthetic heart valve device when the occlusion member is in the second position.

5. The fluid flow dividing device according to claim 1, wherein: The delivery system is configured to cause deployment of the prosthetic heart valve device when the occlusion member is in the first position, and is configured to cause retraction of the prosthetic heart valve device when the occlusion member is in the second position.

6. The fluid diversion device according to claim 1, further comprising: A support structure is configured to receive and retain an inflatable device to the housing, wherein the inflatable device contains a fluid that is pressurized to flow to the first chamber and the second chamber depending on whether the blocking member is in the first position or the second position, respectively.

7. The fluid diversion device according to claim 1, further comprising: a first retaining member configured to retain the actuator in a first position, the actuator disposing the blocking member in the first position, and A second retaining member configured to retain the actuator in a second position, the actuator disposing the blocking member in the second position.

8. The fluid flow dividing device according to claim 7, wherein: The actuator includes a handle operably coupled to the occlusion member to allow the occlusion member to rotate to the first position and the second position.

9. The fluid flow dividing device according to claim 1, wherein: Any combination of the plurality of tubes is blocked to block fluid flow through the plurality of tubes based on the position of the blocking member.

10. The fluid flow distribution device according to claim 1, wherein: The fluid flow rate in each tube is proportional to the rotation angle of the blocking member.

11. The fluid flow dividing device according to claim 1, wherein: Each channel of the plurality of channels is arranged parallel to other channels of the plurality of channels.

12. The fluid flow dividing device according to claim 11, wherein: The blocking member comprises: a first cam subset; and A second subset of cams is arranged in series and rotationally offset relative to the first subset of cams such that the first subset of cams is configured to block the first subset of tubes and the second subset of cams opens the second set of tubes.

13. The fluid flow distribution device according to claim 1, wherein: The plurality of channels include: a first subset of channels arranged in parallel; and A second subset of channels are arranged in parallel, wherein the aperture extends laterally between the second subset of channels and the first subset of channels.

14. The fluid flow dividing device according to claim 13, wherein: The blocking member has only one cam configured to block the first subset of tubes disposed in the first subset of channels when the blocking member is in the first position and to block the second set of tubes in the second subset of channels in an alternating manner when the blocking member is in the second position.

15. The fluid flow dividing device according to claim 14, wherein: When the blocking member is in the third position, the first and second sets of tubes are blocked to prevent any fluid from flowing through the plurality of channels.

16. The fluid flow distribution device according to claim 14, wherein: When the blocking member is in the third position, each of the plurality of tubes is open to allow fluid to flow through all of the plurality of channels.

17. The fluid flow distribution device according to claim 1, wherein: The fluid diversion device is configured to be external to the patient during implantation of the prosthetic heart valve device.

18. 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; a plurality of chambers, the plurality of chambers comprising a first chamber and a second chamber, the first chamber and the second chamber being operable to receive or exhaust a fluid to hydraulically drive deployment and retraction of the prosthetic heart valve device; and A fluid flow dividing device, comprising: a housing comprising a first side, a second side, an aperture, and a plurality of passages through the housing from the first side through the aperture to the second side, wherein the plurality of passages are configured to receive a corresponding plurality of tubes extending from the first side of the housing through the aperture to the second side, and wherein the aperture extends transversely through the plurality of passages, a blocking member disposed in the bore, wherein rotation of the blocking member enables selective blocking of a first set of tubes or a second set of tubes disposed in the plurality of channels, and An actuator operably connected to the blocking member so that the blocking member can be selectively positioned in at least a first position and a second position, the first position blocking the first tube set and the second position blocking the second tube set for fluid communication in different directions relative to the first chamber and the second chamber to cause deployment and retraction of the artificial heart valve device.

19. The system of claim 18, wherein: When the blocking member is in the second position, the first set of tubes is opened and the second set of tubes is blocked to allow fluid to drain from the first chamber and to allow fluid to flow to the second chamber.

20. The system of claim 19, wherein: When the blocking member is in the first position, the first set of tubes is blocked and the second set of tubes is opened to allow fluid to flow to the first chamber and to allow fluid to be discharged from the second chamber.

21. The system of claim 20, further comprising: The elongated catheter body includes a handle and the elongated catheter body includes a second chamber.

22. The system of claim 20, wherein: The delivery control assembly comprises the second chamber.

23. The system of claim 20, wherein: The delivery control assembly comprises the first chamber.

24. A fluid diversion device for controlling fluid flow in a delivery system to deploy a medical device, the fluid diversion device comprising: a housing comprising a plurality of channels configured to receive a corresponding plurality of tubes, and an aperture extending transversely through the plurality of channels; a blocking member disposed in the bore, wherein rotation of the blocking member selectively blocks a first subset of the plurality of tubes or a second subset of the plurality of tubes; as well as An actuator configured to rotate the blocking member to at least a first position and a second position so that the first tube set and the second tube set are alternately blocked in the first position or the second position for fluid communication in different directions relative to a plurality of chambers of a delivery device operable to deploy and retract the medical device.

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