Prosthetic valve delivery system

Abstract

The title of the invention is prosthetic valve delivery system. Embodiments of a delivery apparatus for implanting a prosthetic valve are disclosed. The delivery apparatus can include a handle, a first shaft extending from a distal end of the handle, a second shaft extending through a lumen of the first shaft and the handle, and a gripper located proximal of a proximal end of the handle. A proximal end of the second shaft can be connected to the gripper, and the gripper can be axially movable relative to the handle such that axial movement of the gripper causes corresponding axial movement of the second shaft relative to the first shaft. The gripper can have a bottom surface that is substantially coplanar with a bottom surface of the handle.

Description

[0001] References to relevant applications

[0002] This application claims the benefit of U.S. Provisional Application No. 63 / 085,901, filed on September 30, 2020, which is incorporated herein by reference. Technical Field

[0003] This disclosure relates to embodiments of delivery systems for implanting prosthetic valves, such as prosthetic pulmonary valves. Background Technology

[0004] The human heart can suffer from various valvular diseases. These valvular diseases can lead to serious dysfunction of the heart and ultimately require repair of the natural valve or replacement with an artificial valve. Many known repair devices (e.g., stents) and artificial valves exist, along with many known methods for implanting these devices and valves into the human body. Percutaneous and minimally invasive surgical methods are used in various procedures to deliver prosthetic medical devices to locations inside the body that are not easily accessible surgically or where surgical access is desired. In one specific example, a prosthetic heart valve may be mounted in a coiled state at the distal end of a delivery device and advanced through the patient's vascular system (e.g., through the femoral and aortic arteries) until the prosthetic valve reaches the implantation site in the heart. The prosthetic valve is then expanded to its functional size, for example, by inflating a balloon with the prosthetic valve implanted, actuating a mechanical actuator that applies an expansion force to the prosthetic valve, or by deploying the prosthetic valve from the sheath of the delivery device, allowing the prosthetic valve to self-expand to its functional size.

[0005] Transcatheter heart valves can be appropriately sized to fit within most natural aortic valves. However, for larger natural valves, vessels, and grafts, a transcatheter aortic valve may be too small to be secured to a larger implantation or deployment site. In such cases, the transcatheter valve may not be large enough to adequately expand within the natural valve or other implantation or deployment site for secure placement.

[0006] Pulmonary valve replacement (sometimes called pulmonary valve) presents significant challenges. The geometry of the pulmonary artery can vary from patient to patient. Often, the pulmonary outflow tract after corrective surgery is too wide to provide sufficient support for effective placement of a prosthetic heart valve.

[0007] One example approach to overcome this challenge is to use a docking device or docking station that is configured to be pre-implanted in the target implant site, and then a prosthetic valve can be deployed within the docking device. The docking device can be configured to compensate for a prosthetic valve that is smaller than the annular space in which it is to be placed. However, conventional delivery systems for aortic valve implantation can not be convenient for delivering and implanting a prosthetic valve at the native pulmonary valve. Thus, improvements in transcatheter delivery apparatuses are desirable. SUMMARY

[0008] The present disclosure relates to methods and devices related to the transluminal implantation of prosthetic valves, such as prosthetic pulmonary valves.

[0009] Certain embodiments of the present disclosure relate to a delivery apparatus for implanting a prosthetic valve. The delivery apparatus can include a handle, a first shaft extending from a distal end of the handle, a second shaft extending through a lumen of the first shaft and the handle, and a gripper located proximal of a proximal end of the handle. A proximal end of the second shaft can be connected to the gripper, and the gripper can be axially movable relative to the handle such that axial movement of the gripper causes corresponding axial movement of the second shaft relative to the first shaft. The gripper can have a bottom surface that is substantially coplanar with a bottom surface of the handle.

[0010] Certain embodiments of the present disclosure also relate to another delivery apparatus for implanting a prosthetic valve. The delivery apparatus can include a handle, a first shaft extending from a distal end of the handle, a second shaft extending through a lumen of the first shaft and the handle, and a gripper located proximal of a proximal end of the handle. A proximal end of the second shaft can be connected to the gripper, and the gripper can be axially movable relative to the handle such that axial movement of the gripper causes corresponding axial movement of the second shaft relative to the first shaft. A distance from a longitudinal axis of the second shaft to a bottom surface of the gripper can be substantially the same as a distance from a longitudinal axis of the first shaft to a bottom surface of the handle.

[0011] Certain embodiments of the present disclosure relate to yet another delivery apparatus for implanting a prosthetic valve. The delivery apparatus can include a handle having a locking mechanism, a first shaft extending from a distal end of the handle, and a second shaft extending through the handle. The locking mechanism can include a rotatable lock body having internal threads and a collet at least partially received within the lock body. The collet can include external threads that engage the internal threads of the lock body and is coaxially disposed around the second shaft. Rotation of the lock body can cause axial movement of the collet relative to the lock body and the second shaft. The lock body can be rotatable between a locked position and an unlocked position. When the lock body is in the unlocked position, the second shaft can be axially movable relative to the handle, the first shaft, and the collet, and when the lock body is in the unlocked position, the collet can prevent axial movement of the second shaft relative to the first shaft and the handle.

[0012] Certain embodiments of the present disclosure are also directed to another delivery apparatus for implanting a prosthetic valve. The delivery apparatus can include a handle having a locking mechanism including a lock body having a user-engageable portion, a first shaft extending from a distal end of the handle, and a second shaft extending through the handle. The lock body can be movable between a locked position and an unlocked position. The second shaft can be axially movable relative to the handle and the first shaft when the lock body is in the unlocked position. The second shaft is not axially movable relative to the first shaft and the handle when the lock body is in the unlocked position. The delivery apparatus can further include at least one detent element positioned to engage the user-engageable portion when the lock body is in the locked position or the unlocked position.

[0013] Certain embodiments of the present disclosure are further directed to another delivery apparatus. The delivery apparatus can include a handle having a chamber and a detent disposed inside the chamber, a first shaft extending from a distal end of the handle, a clamp located proximal to a proximal end of the handle, and a second shaft extending through an opening on the handle and the detent. A proximal end of the second shaft can be connected to the clamp. The clamp can be configured to be axially movable relative to the handle such that axial movement of the clamp causes corresponding axial movement of the second shaft relative to the first shaft and the handle. The second shaft can include a flared portion. A diameter of the flared portion can be greater than a diameter of the opening on the detent such that proximal movement of the second shaft is blocked when the flared portion abuts the detent.

[0014] Certain embodiments of the present disclosure are also directed to a method for implanting a prosthetic valve. The method can include inserting a delivery apparatus into a vasculature of a patient, the delivery apparatus including a handle, a first shaft extending from a distal end of the handle, and a second shaft extending through a lumen of the first shaft and the handle. A prosthetic valve can be crimped over an unexpanded balloon coupled to a distal portion of the second shaft, and the prosthetic valve can be covered by a valve sheath connected to a distal portion of the first shaft. A proximal end of the second shaft can be connected to a clamp located proximal to a proximal end of the handle. A distance from an axial axis of the second shaft to a bottom surface of the clamp can be substantially the same as a distance from an axial axis of the first shaft to a bottom surface of the handle.

[0015] Some embodiments of this disclosure further relate to an assembly including a radially expandable and compressible prosthetic valve and a delivery device including a handle, a gripper located proximal to the proximal end of the handle, a first shaft extending from the distal end of the handle, and a second shaft extending through a cavity of the first shaft and the handle. The proximal end of the second shaft may be connected to the gripper. The prosthetic valve may be mounted on an inflatable balloon coupled to the distal portion of the second shaft. The handle may include a locking mechanism. The locking mechanism may include a locking body having a user-engageable portion. The locking body is movable between a locked position and an unlocked position. When the locking body is in the unlocked position, the gripper is axially movable relative to the handle, and when the locking body is in the unlocked position, the gripper is not axially movable relative to the handle. The user-engageable portion may be configured to engage at least one braking element when the locking body is in the locked or unlocked position.

[0016] The foregoing and other objects, features and advantages of the disclosed technology will become more apparent from the following detailed description with reference to the accompanying drawings. Attached Figure Description

[0017] Figure 1 This is a three-dimensional view of a prosthetic heart valve according to one embodiment.

[0018] Figure 2 This is a perspective view of a delivery device according to one embodiment, showing a valve sheath covering the distal portion of a balloon catheter in a distal position.

[0019] Figure 3 yes Figure 2 The image depicts a three-dimensional view of the delivery device, showing the valve sheath of the distal portion of the uncovering balloon catheter in a proximal position.

[0020] Figure 3A yes Figure 3 Side view of the nose cone and distal shoulder of the delivery device.

[0021] picture Figure 3B yes Figure 3A A cross-sectional view of the nasal cone.

[0022] Figure 4A yes Figure 3 A side view of the distal portion of the balloon catheter depicted in the image.

[0023] Figure 4B It is installed in Figure 3 The image depicts a side view of the prosthetic valve on the distal portion of the balloon catheter.

[0024] Figure 5 yes Figure 3Cross-sectional view of a distal portion of the balloon catheter and balloon mounted thereon.

[0025] Figure 5A is Figure 5 Close-up view of the proximal shoulder of the balloon catheter depicted in

[0026] Figure 6 Different layers of the outer sheath and valve sheath of the delivery device according to one embodiment are shown.

[0027] Figure 7 is a side view of an inline introducer according to one embodiment.

[0028] Figure 8 is a side view of a distal portion of the delivery device, wherein a proximal end of the valve sheath abuts Figure 7 Distal end of the sheath of the introducer depicted in

[0029] Figure 9 is a side view of a dilator according to one embodiment.

[0030] Figure 10A is Figure 2 Handle and gripper of the delivery device of

[0031] Figure 10B is Figure 10A Side view of the handle and gripper depicted in

[0032] Figure 11 is Figure 10A Exploded perspective view of the handle and gripper depicted in

[0033] Figure 12 is Figure 10A Cross-sectional view of the handle and gripper depicted in

[0034] Figure 12A is Figure 12 Close-up view of a portion of the handle depicted in

[0035] Figure 13 is Figure 10A Perspective view of the gripper depicted in

[0036] Figure 14 is a side view of a Y-connector integrated with the gripper depicted in Figure 10A

[0037] Components of the locking mechanism of the handle according to one embodiment are shown in a disassembled state. Figure 15A

[0038] Figure 15B Components of the handle according to one embodiment are shown in an assembled state. Figure 15B ​Parts of the locking mechanism are depicted.

[0039] Figure 16 is a perspective view of a hypotube according to one embodiment.

[0040] Figure 16A is Figure 16 is a close-up view of the proximal end of the hypotube depicted in

[0041] Figure 17 is a perspective view of a prosthetic valve delivery apparatus according to another embodiment.

[0042] Figure 18 is a side view of a docking stent according to one embodiment.

[0043] Figure 19 is a side view of a prosthetic valve held by the docking stent according to one embodiment. Figure 20

[0044] Figure 20 is a side view of a delivery apparatus for a docking stent according to one embodiment.

[0045] Figure 20A is Figure 20 is a close-up view of the valve connection of the delivery apparatus depicted in

[0046] Figure 21A shows introduction of a first delivery apparatus into a pulmonary artery according to one embodiment.

[0047] Figure 21B shows partial expansion of a docking stent from the first delivery apparatus at a location corresponding to a native pulmonary valve according to one embodiment.

[0048] Figure 21C shows full expansion of a docking stent at a location corresponding to a native pulmonary valve according to one embodiment.

[0049] Figure 21D shows withdrawal of the first delivery apparatus from the pulmonary artery according to one embodiment.

[0050] Figure 21E shows introduction of a second delivery apparatus carrying a prosthetic valve into a pulmonary artery according to one embodiment.

[0051] Figure 21F shows retraction of a sheath of the second delivery apparatus to expose the prosthetic valve and position the prosthetic valve within the docking stent according to one embodiment.

[0052] Figure 21G ​An expandable balloon of a second delivery apparatus is shown expanding the prosthetic valve within the docking stent member according to one embodiment.

[0053] Figure 21H A second delivery apparatus is shown being extracted from the pulmonary artery according to one embodiment. DETAILED DESCRIPTION

[0054] Figure 1 A perspective view of a prosthetic heart valve 10 according to one embodiment is shown. The example valve can be adapted for implantation in a native pulmonary artery annulus, but in other embodiments it can be adapted for implantation in other native annulus of the heart, such as a native aortic annulus. The valve 10 can have four main components: a stent or frame 12, a valve structure 14, an inner skirt 16, and an outer skirt 18.

[0055] The valve structure 14 can include three leaflets 40, collectively forming a leaflet structure (although a greater or lesser number of leaflets can be used), which can be arranged to collapse in a tricuspid arrangement. The leaflets 40 are configured to allow blood to flow from an inflow end 22 to an outflow end 24 of the prosthetic valve 10 and to prevent blood from flowing from the outflow end 24 to the inflow end 22 of the prosthetic valve 10. The leaflets 40 can be secured to one another at their adjacent sides to form commissures 26 of the leaflet structure. The lower edge of the leaflet structure 14 desirably has a scalloped, curved, scallop shape. By forming the leaflets with this scallop geometry, stress on the leaflets can be reduced, which in turn can improve durability of the valve. Furthermore, due to the scallop shape, folds and wrinkles that can cause early calcification in the center regions of the leaflets (the belly of each leaflet) can be eliminated or at least minimized. The scallop geometry can also reduce the amount of tissue material used to form the leaflet structure, allowing for a smaller, more uniform crimp profile at the inflow end of the valve. The leaflets 40 can be formed of pericardial tissue (e.g., bovine pericardial tissue), biocompatible synthetic materials, or various other suitable natural or synthetic materials known in the art and described in U.S. Patent No. 6,730,118, which is incorporated by reference herein.

[0056] Frame 12 can be formed with a plurality of circumferentially spaced apart slots or commissure windows 20 (three in the illustrated embodiment) adapted to mount commissures 26 of valve structure 14 to the frame. Frame 12 can be made of any of a variety of suitable plastically expandable materials (e.g., stainless steel, etc.) or self-expanding materials (e.g., Nitinol) known in the art. When composed of a plastically expandable material, frame 12 (and thus valve 10) can be crimped to a radially compressed state on a delivery apparatus and then expanded within the patient's body by an inflatable balloon or equivalent expansion mechanism. When composed of a self-expanding material, frame 12 (and thus valve 10) can be crimped to a radially compressed state and restrained in the compressed state by insertion into a sheath or equivalent mechanism of a delivery apparatus. Once within the body, the valve can be advanced from the delivery sheath, which allows the valve to expand to its functional size.

[0057] Suitable plastically expandable materials that can be used to form frame 12 include, but are not limited to, stainless steel, nickel-based alloys (e.g., cobalt-chromium or nickel-cobalt-chromium alloys), polymers, or combinations thereof. In a particular embodiment, frame 12 is made of a nickel-cobalt-chromium-molybdenum alloy, such as MP35N TM (SPS Technologies trade name), which is equivalent to UNS R30035 (covered by ASTM F562-02). MP35N™ / UNS R30035 contains 35% by weight nickel, 35% cobalt, 20% chromium, and 10% molybdenum. It has been found that using MP35N to form frame 12 can provide structural benefits over stainless steel. In particular, less material is needed to achieve the same or better performance in radial and crush resistance, fatigue resistance, and corrosion resistance performance when using MP35N as the frame material. Moreover, because less material is needed, the crimp profile of the frame can be reduced, thereby providing a lower profile valve assembly for percutaneous delivery to a treatment site in the body.

[0058] The inner skirt 16 can be secured to the inner side of the frame 12 by sutures. In some embodiments, the valve structure 14 can be attached to the inner skirt 16 by one or more thin polyethylene terephthalate (PET) reinforcing bands, which can enable secure suturing and protect the pericardial tissue of the leaflet structure from tearing. The inner skirt 16 can help secure the valve structure 14 to the frame 12 and help create a good seal between the valve and the native valve annulus by blocking blood flow through the open cells below the lower edge of the leaflets. The inner skirt 16 desirably comprises a tough, tear-resistant material, such as PET, although various other synthetic or natural materials can be used. The thickness of the inner skirt is desirably less than 6 mils, desirably less than 4 mils, and even more desirably about 2 mils. In particular embodiments, the inner skirt 16 can have a variable thickness, e.g., the skirt can be thicker at its edges than at its center. In one embodiment, the inner skirt 16 can comprise a PET skirt having a thickness of about 0.07 mm at its edges and about 0.06 mm at its center. A thinner inner skirt edge can provide better crimping performance while still providing a good paravalvular seal.

[0059] The outer skirt 18 can be laser cut or otherwise formed from a piece of strong, durable material, such as woven PET, although other synthetic or natural materials can be used. The outer skirt 18 can be secured to the outer side of the frame 12 by sutures. The outer skirt 18 can be configured so that when the frame is in its expanded state, there is excess material or slack between the lower and upper edges of the skirt that does not lie flat against the outer surface of the frame 12. The slack between the lower and upper edges of the outer skirt 18 allows the frame 12 to elongate axially when crimped without any resistance from the outer skirt. Also, the excess material of the outer skirt 18 can fill the gap between the frame 12 and the surrounding native valve annulus when the valve 10 is deployed in the body to help create a good fluid-tight seal between the valve and the native valve annulus. When implanted in an outer docking stent (as described below), the outer skirt 18 can seal against the inner surface of the docking stent. Thus, the outer skirt 18 can cooperate with the inner skirt 16 to avoid paravalvular leakage after implantation of the valve 10.

[0060] Further details of the valve 10 and its components are described in U.S. Patent No. 9,393,110, which is incorporated by reference herein.

[0061] Figures 2-3A delivery device 100 according to one embodiment is shown, which can be used to implant a prosthetic valve (such as prosthetic valve 10) on a target implantation side of a patient (such as a natural pulmonary annulus). In a specific embodiment, as described in detail below, the delivery device 100 can be used to implant a prosthetic valve within a docking stent implanted in a natural pulmonary annulus or pulmonary artery.

[0062] As shown, the delivery device 100 may include a handle 102, a first shaft 104 (which is an outer shaft in the example embodiment) extending distally from the handle 102, and a second shaft 106 (which is an intermediate shaft in the example embodiment) extending through a cavity of the first shaft 104 and the handle 102. The second shaft may also be referred to as a “balloon shaft” because an inflatable balloon is mounted on the distal portion of the second shaft, as described in more detail below. The delivery device 100 may also include a third shaft 108 (which is an inner shaft in the illustrated embodiment) extending through a cavity of the second shaft 106. The distal end of the third shaft 108 may be connected to a nasal cone 110, which may have a tapered distal portion for non-invasive navigation through the patient’s vascular system. In some embodiments, a guidewire (not shown) may extend through the third shaft 108 and the cavity of the nasal cone 110, allowing the delivery device 100 to navigate through the patient’s vascular system over a previously inserted guidewire.

[0063] As shown in the figure, the delivery device 100 includes a gripper 112 located proximal to the proximal end 114 of the handle 102. As described more fully below, the proximal end of the balloon shaft 106 can be connected to the gripper 112 such that axial movement of the gripper 112 relative to the handle 102 causes a corresponding axial movement of the balloon shaft 106 relative to the outer shaft 104 (and the handle 102). Similarly, the proximal end of the inner shaft 108 can also be connected to the gripper 112 such that axial movement of the gripper 112 relative to the handle 102 causes a corresponding axial movement of the inner shaft 108 relative to the outer shaft 104 (and the handle). Thus, in the exemplary embodiment, axial movement of the gripper 112 relative to the handle 102 causes the inner shaft 108 and the balloon shaft 106 to move together relative to the handle 102 and the outer shaft 104.

[0064] like Figure 3 and Figures 4A-4B As shown, the distal portion of the delivery device 100 may have a balloon shoulder assembly 120 configured to mount an inflatable balloon thereto as described below. The balloon shoulder assembly 120 includes a proximal shoulder 122 connected to the distal portion of the balloon shaft 106 and a distal shoulder 124 connected to the distal portion of the inner shaft 108. The proximal shoulder 122 and the distal shoulder 124 are spaced apart from each other in an axial direction relative to the central longitudinal axis of the delivery device 100.

[0065] In some embodiments, the proximal shoulder 122 can be affixed to the distal end portion of the balloon shaft 106 using any known means, such as by welding, adhesive, mechanical fasteners, etc. Likewise, the distal shoulder 124 can be affixed to the distal end portion of the inner shaft 108 using any known means, such as by welding, adhesive, mechanical fasteners, etc.

[0066] The distal shoulder 124 can have a distal leg portion 124d and a proximal flared portion 124p having a larger diameter than the distal leg portion 124d (see, e.g., FIG. 1). Similarly, the proximal shoulder 122 can have a proximal leg portion and a distal flared portion having a larger diameter than the proximal leg portion. Figure 3A ) The distal shoulder 124 can have a distal leg portion 124d and a proximal flared portion 124p having a larger diameter than the distal leg portion 124d (see, e.g., FIG. 1). Similarly, the proximal shoulder 122 can have a proximal leg portion and a distal flared portion having a larger diameter than the proximal leg portion.

[0067] In certain instances, the distal leg portion 124d and the proximal flared portion 124p of the distal shoulder 124 can be formed as a unitary piece molded from a thermoplastic elastomer, such as Pebax. The distal shoulder 124 can have a durometer in the range of about 35D to about 75D. In one particular instance, the distal shoulder 124 has a durometer of about 55D. Similarly, the proximal leg portion and the distal flared portion of the proximal shoulder 122 can be formed as a unitary piece molded from the same or similar material as the distal shoulder 124. In other instances, the distal leg portion 124d and the proximal flared portion 124p of the distal shoulder 124 (and / or the proximal leg portion and the distal flared portion of the proximal shoulder 122) can be initially formed as separated pieces that are then joined together.

[0068] In some embodiments, the nosecone 110 and the distal shoulder 124 can be unitary or integral components, i.e., the nosecone 110 is a distal portion of an integral component and the distal shoulder 124 is a proximal portion of the integral component. In other embodiments, the nosecone 110 and the distal shoulder 124 can be separate components and each can be mounted on the inner shaft 108 adjacent to one another or at axially spaced apart locations.

[0069] Figures 3A-3BA nosecone 110 according to certain examples is further depicted. As shown, the nosecone 110 can have a body portion 101 and an interface portion 103 extending proximally from the body portion 101. The body portion 101 can have a tapered shape with a diameter that gradually decreases from a proximal end portion 101p of the body portion 101 to a distal tip portion 101d of the body portion 101. The body portion 101, including the distal tip portion 101d thereof, can comprise a flexible material such that the distal tip portion 101d can flex during tracking of the patient’s vasculature during insertion and / or implantation of the delivery apparatus.

[0070] The proximal end portion 101p of the body portion 101 can have an engagement end 111 configured to engage a distal end of a valve sheath (e.g., 138), as further described below. The outer diameter at the engagement end 111 can define a maximum outer diameter of the nosecone 110. As shown, the interface portion 103 can have a generally cylindrical shape and have an outer diameter that is less than the outer diameter at the engagement end 111. Thus, the diameter can step down from the proximal end of the body portion 101 to the interface portion 103, thereby forming a perpendicular wall 107 that is substantially perpendicular to a central longitudinal axis of the delivery apparatus 100. In other examples, the interface portion 103 can have a partially spherical shape. Figures 3A-3B

[0071] As described below, a valve sheath (e.g., 138) can be in a covering position (see, e.g., FIG. 6) to cover a radially compressed prosthetic valve (e.g., 10) folded around the balloon shoulder assembly 120. In the covering position, the engagement end 111 of the nosecone 110 can abut the distal end of the valve sheath. As a result, when the distal tip portion 101d of the nosecone 110 flexes during the insertion and / or tracking process, the distal end of the valve sheath can remain in contact with the perpendicular wall 107 of the nosecone 110 (i.e., preventing axial separation and / or a gap between the engagement end 111 of the nosecone 110 and the distal end of the valve sheath). Figure 2

[0072] In some examples, the outer diameter of the interface portion 103 can be about the same or slightly less than the inner diameter of the valve sheath such that the distal end portion of the valve sheath can frictionally engage the outer surface of the interface portion 103. Additionally, the outer diameter at the engagement end 111 can be about the same as the outer diameter of the valve sheath. In other words, the height of the perpendicular wall 107 (i.e., the difference between the outer diameter at the engagement end 111 and the outer diameter of the interface portion 103) can be about the same as the thickness of the valve sheath (i.e., the difference between the outer diameter and the inner diameter of the valve sheath). Thus, when the valve sheath is in the covering position, the outer surface of the valve sheath and the outer surface of the body portion 101 of the nosecone 110 can form a continuous smooth surface (i.e., without a step-up or step-down in outer diameter). ​​

[0073] As Figures 3A-3B depicted, the nosecone 110 can have a lumen 117 configured to receive the guidewire 129 and a proximal groove 121 configured to receive the distal leg portion 124d of the distal shoulder 124. Figure 3A An exploded view of the nosecone 110 and the distal shoulder 124 is shown. The diameter of the proximal groove 121 can be larger than the diameter of the lumen 117. The proximal groove 121 can extend from the proximal end of the hub portion 103 into the body portion 101. The lumen 117 can extend from the distal end of the proximal groove 121 to the distal end of the body portion 101. During assembly, the distal leg portion 124d can be inserted into the groove 121. The distal leg portion 124d can be joined to the nosecone 110, such as by induction welding, adhesive, etc. The nosecone 110 can be made of the same material as the distal shoulder 124. In some examples, the nosecone 110 and the distal shoulder 124 are made of Pebax, such as Pebax having a hardness of about 55D.

[0074] Figure 5 And Figure 5A A cross-sectional view of the balloon shoulder assembly 120 and the inflatable balloon 126 folded around the proximal and distal shoulders is shown. The balloon 126 has a proximal portion 132 wrapped and / or folded over the proximal shoulder 122 and a distal portion 134 wrapped and / or folded over the distal shoulder 124. The balloon 126 also has a valve retention portion 130 between the proximal end 132 and the distal portion 134, the valve retention portion 130 wrapped and / or folded in the space separating the proximal shoulder 122 and the distal shoulder 124 (e.g., between the flared ends of the proximal shoulder 122 and the distal shoulder 124).

[0075] As Figure 4B illustrated, the prosthetic heart valve 10 can be crimped onto the valve retention portion 128 of the balloon 126 between the proximal and distal shoulders, which prevents or reduces axial movement of the prosthetic valve 10 relative to the balloon 126 during insertion of the delivery apparatus 100 into the vasculature of a patient and delivery of the prosthetic valve 10 to the target implant site.

[0076] As Figure 5 and Figure 5A shown, the outer diameter of the inner shaft 108 can be sized such that an annular space 128 is defined between the inner shaft 108 and the balloon shaft 106 along the entire length of the balloon shaft 106. The annular space 128 can be fluidly coupled to one or more fluid channels of the delivery apparatus 100 that can be fluidly connected to a fluid source (e.g., a syringe) that can inject inflation fluid (e.g., saline) into the delivery apparatus. In this manner, fluid from the fluid source can flow through the one or more fluid channels, through the annular space 128, and into the balloon 126 to inflate the balloon 126 and expand and deploy the prosthetic valve 10.Figure 5 The illustration shows fluid (indicated by arrow 109) flowing through the annular space 128 and through pathways in the proximal shoulder 122 and distal shoulder 124. The fluid can then flow into the balloon 126 to dilate the valve 10.

[0077] In some embodiments, a radiopaque marker 136 may be placed between the proximal shoulder 122 and the distal shoulder 124. For example, the radiopaque marker 136 may be placed on the outer surface of the inner axis 108 and aligned with the center of the valve retaining portion 130 of the balloon 126. As described below, the radiopaque marker 136 can be used to align the prosthetic valve 10 with the natural valve under fluorescence examination during the implantation procedure. The radiopaque marker 136 may be optional. For example, in some embodiments, no radiopaque marker is placed between the proximal shoulder 122 and the distal shoulder 124.

[0078] Further details regarding the balloon shoulder assembly, methods of mounting a folded balloon to the balloon shoulder assembly, and methods of rolling a prosthetic valve to the valve retention portion of the balloon are disclosed in U.S. Publications 2007 / 0005131, 2009 / 0281619, 2013 / 0030519, 2017 / 0065415 and U.S. Application No. 62 / 911,861, all of which are incorporated herein by reference.

[0079] like Figures 2-3 As shown, the delivery device 100 may further include a valve sheath 138 (also referred to as a delivery capsule) configured to cover the prosthetic valve 10 mounted on the balloon 126 in a radially compressed state. In the depicted embodiment, the proximal end 138p of the valve sheath 138 is connected to the distal end 104d of the outer axis 104. In some embodiments, the proximal end 138p of the valve sheath 138 may be securely coupled to the distal end 104d of the outer axis 104 by any known means, such as welding, adhesives, etc.

[0080] As described above, both the balloon shaft 106 and the inner shaft 108 are axially movable relative to the outer shaft 104. Therefore, the valve sheath 138, connected to the outer shaft 104, is axially movable relative to the proximal shoulder 122 connected to the balloon shaft 106 and the distal shoulder connected to the inner shaft 108. Specifically, the valve sheath 138 can be as follows: Figure 2 The coverage location shown and as Figure 3 Move between the indicated uncovered positions.

[0081] When the valve sheath 138 is in the covered position ( Figure 2The nasal cone 110's confluent end 111 may abut the distal end 138d of the valve sheath 138. The length (L) of the valve sheath 138 is configured to be slightly longer than the entire length of the balloon shoulder assembly 120 (measured from the proximal end of the proximal shoulder 122 to the distal end of the distal shoulder 124). Therefore, when the valve sheath 138 is in the covered position, the balloon 126 folded around the balloon shoulder assembly 120 can be completely covered by the valve sheath 138. Furthermore, the inner diameter of the valve sheath 138 is configured to be slightly larger than the radial diameter when the prosthetic valve 10 is rolled onto the valve holding portion 130 of the balloon 126. Therefore, when the valve sheath 138 is in the covered position, the radially compressed prosthetic valve 10 can be held inside the valve sheath 138. As described below, the prosthetic valve 10 is held inside the valve sheath 138 as navigation proceeds through the patient's vascular system (e.g., through the tricuspid cordae). Therefore, the sheath 138 protects the inner surface of the patient's vascular system from contact with the outer surface of the prosthetic valve 10 as the delivery device and the prosthetic valve are inserted into and advanced through the patient's vascular system to the implantation site.

[0082] In the depicted embodiments, the outer diameter of the valve sheath 138 is larger than the outer diameter of the outer axis 104. For example, the outer diameter of the valve sheath 138 may range from about 8 mm to about 11 mm in some instances, more preferably between about 9 mm and 10 mm in some instances, and even more preferably between about 9.4 mm and 9.6 mm (e.g., 9.5 mm) in some instances. The outer diameter of the outer axis 104 may range from about 3 mm to about 8 mm in some instances, more preferably between about 5 mm and 6 mm in some instances, and even more preferably between about 5.5 mm and 5.7 mm (e.g., 5.6 mm) in some instances. In other embodiments, the outer diameter of the valve sheath 138 may be approximately the same as the outer diameter of the outer axis 104.

[0083] like Figure 2 As shown, the outer diameter of the valve sheath 138 can be approximately the same as the outer diameter at the junction 111 of the nasal cone 110. Therefore, when the valve sheath 138 is in the covered position, the outer surfaces of the valve sheath 138 and the nasal cone 110 can form a continuous smooth surface, gradually tapering from the valve sheath 138 to the distal end of the nasal cone 110. In some embodiments, the outer surfaces of both the valve sheath 138 and the nasal cone 110 are coated with a hydrophilic material to facilitate navigation through the patient's vascular system.

[0084] When the valve sheath 138 is in the uncovered position ( Figure 3 The distal end 138d of the valve sheath 138 moves to a position closer to the proximal shoulder 122. Therefore, the balloon 126, positioned between the shoulders 122 and 124, can be exposed (note, Figure 3The balloon is omitted in this view to illustrate the underlying shoulder). Moreover, if the prosthetic valve 10 is crimped onto the valve retention portion 130 of the balloon 126, the prosthetic valve 10 can be exposed when the valve sheath 138 is in the uncovered position, as Figure 4B illustrated. In one particular embodiment, the axial distance (D1) between the distal end 138d of the valve sheath 138 and the engagement end 111 of the nosecone 110 is about the same as the axial length (L) of the valve sheath 138 when the valve sheath 138 is in the uncovered position Figure 3 ). In other embodiments, the length (L) can be greater than the distance (D1).

[0085] In some embodiments, the axial distance (D2) between the proximal end 114 of the handle 102 and the distal end 112d of the gripper 112 is about the same as the distance (D1) when the valve sheath 138 is in the covered position Figure 2 . Thus, when the distance (D1) is about the same as the axial length (L) of the valve sheath 138, the distance (D2) is about the same as the length (L). Thus, if the prosthetic valve 10 is initially retained within the valve sheath 138, the valve sheath 138 is moved to the uncovered position and the prosthetic valve 10 can be exposed by axially moving the handle 102 relative to the gripper 112 until the proximal end 114 of the handle 102 abuts the distal end 112d of the gripper 112.

[0086] In some embodiments, the outer shaft 104 can include multiple segments that vary in flexibility along its length. For example, the outer shaft 104 can have a proximal segment 105a, an intermediate segment 105b, and a distal segment 105c. The proximal segment can have a higher durometer than the intermediate segment, and the intermediate segment can have a higher durometer than the distal segment. In one particular embodiment, the proximal segment 105a has a durometer of 72D, the intermediate segment 105b has a durometer of 55D, and the distal segment 105c has a durometer of 35D. Thus, the higher flexibility of the distal segment makes it easier to advance through tortuous vasculature, and the stiffer intermediate and proximal segments allow for improved steering ability and pushability of the delivery apparatus 100. In other embodiments, the outer shaft 104 can include any number of segments (e.g., 1, 2, 4, 5, etc.) having different durometers along its length.

[0087] In some embodiments, the outer shaft 104 (and / or the valve sheath 138) can be constructed using a multi-layer structure to produce desired elasticity and / or stiffness at different segments along its length. For example, Figure 6A tube 140 (which can be part of the outer shaft 104 and / or the valve sheath 138) having a multi-layer structure according to one embodiment is illustrated. In this example, the tube 140 includes an inner liner 142, an optional tie layer 143 extending over the inner liner 142, an optional helical coil member 144 wrapped around the tie layer 143 and the inner liner 142, a braided layer 146 covering the coil member 144, and a heat shrink layer 149 extending over the ends of the coil member 144 for retention purposes, and an outer layer 148 covering the braided layer 146. The inner liner 142, the braided layer 146, and the outer layer 148 can extend the full length of the outer shaft 104 and the valve sheath 138, where the valve sheath 138 has a larger outer diameter than the outer shaft 104. In some embodiments, the coil member 144 can extend from the distal end 138d to the proximal end 138p of the valve sheath. The heat shrink layer 149 can cover a small section of the coil member 144 at the distal end 138d and the proximal end 138p to retain the coil member 144. In certain embodiments, the tie layer 143 can extend from the distal end of the valve sheath 138 to the proximal end of the distal section 105c of the outer shaft 104.

[0088] In certain embodiments, the inner liner 142 can be made of polytetrafluoroethylene (PTFE), and the tie layer 143 and the outer layer 148 can be made of a thermoplastic elastomer such as Pebax. By applying heat to the heat shrink layer 149 (e.g., a PET material), the heat shrink layer can shrink and apply an inward pressure to the coil member 144. This inward pressure can help retain the coil member 144 at the distal end 138d and the proximal end 138p. In certain embodiments, the multi-layer shaft 140 can be covered with a disposable heat shrink layer (e.g., fluorinated ethylene propylene or FEP) and heat can be applied to the entire shaft. The heated outer layer 148 flows into the braided layer 146 and the coil layer 144 to bond these layers together. The multi-layer shaft can then be cooled, and the disposable heat shrink layer (e.g., FEP) can then be removed. By incorporating the helical coil member 144, a section of the tube 140 can be configured to have higher hoop strength and greater kink resistance. On the other hand, a section of the tube 140 can be configured to be more flexible by removing the coil member 144 with an outer layer (e.g., a thermoplastic elastomer) of different hardness. The braided layer 146 also enhances the kink resistance of the shaft. In some embodiments, the braided layer 146 can be configured to have a reduced weave density or can be removed entirely to further increase the flexibility of a section of the tube 140.

[0089] As Figures 2-3 and Figures 7-8As shown, the delivery apparatus 100 has an integrated over-the-wire guide catheter 115 that includes a sheath 116 and a flush port member 118 (also referred to as a hub) connected to the proximal end of the sheath 116. The outer shaft 104 can be configured to extend through the inner lumen of the sheath 116 and the flush port member 118. The flush port member 118 can house one or more seals through which the outer shaft 104 extends. The one or more seals can establish a fluid-tight seal against the outer surface of the outer shaft 104. In addition, the delivery apparatus 100 can include a dilator 115 (FIG. 10) having a tapered tip and configured to dilate a surgical opening in a blood vessel (e.g., a femoral vein) to facilitate insertion of the distal end portion of the delivery apparatus and the guide catheter into the blood vessel.

[0090] The flush port member 118 can have a flush port 119 through which a fluid, such as saline, can be injected into the guide catheter to flush the inner lumen of the sheath 116 and the outer surface of the outer shaft 114. As Figure 8 As best shown, the outer diameter of the delivery sheath 138 can be greater than the outer diameter of the sheath 116. In some examples, the outer diameter of the sheath 116 can range from about 5 mm to about 12 mm, in some examples more desirably between about 7 mm and 10 mm, and in some examples even more desirably between about 8.2 mm and 8.6 mm (e.g., 8.4 mm).

[0091] In addition, the outer shaft 104 and the valve sheath 138 connected thereto are configured to be axially movable relative to the sheath 116 and the flush port member 118. For example, Figures 2-3 The outer shaft 104 is shown advanced distally relative to the sheath 116 such that the proximal end 138p of the valve sheath 138 is separated from the distal end 116d of the sheath 116. On the other hand, Figure 8 The outer shaft 104 is shown advanced distally relative to the sheath 116 such that the proximal end 138p of the valve sheath 138 is separated from the distal end 116d of the sheath 116. On the other hand,

[0092] FIGS. 10-12 illustrate the handle 102, the gripper 112, and their respective components, according to one embodiment. As described above and indicated by the double-headed arrow 113, the handle 102 and the gripper 112 can be axially movable relative to each other. In addition, the handle 102 can include a locking mechanism 150 that can selectively lock and allow axial movement of the handle 102 relative to the gripper 112. For example, the locking mechanism 150 can include a lock body 152 that is movable between a locked position (L) and an unlocked position (U), as indicated by the arrow 153. As Figure 10AIdeally, the locked and unlocked positions can be marked on the handle using visual indicators for the operator's convenience. As described more fully below, the locking mechanism 150 can be configured such that when the locking body 152 is in the unlocked position, the gripper 112 and its connected shafts (e.g., balloon shaft 106 and inner shaft 108) are axially movable relative to the handle 102 and outer shaft 104. Conversely, when the locking body 152 is in the locked position, the gripper 112 and its connected shafts (e.g., balloon shaft 106 and inner shaft 108) are not axially movable relative to the handle 102 and outer shaft 104.

[0093] like Figure 10B As shown, according to one exemplary embodiment, the gripper 112 has a bottom surface 112b that is coplanar or substantially coplanar with the bottom surface 102b of the handle 102. The coplanar design of surfaces 102b and 112b is advantageous because it facilitates linear movement of the handle 102 relative to the gripper 112. For example, in use, a physician may place the handle 102 and the gripper 112 on a surface, such as on an operating table or on a patient's thigh. If the bottom surfaces 102b and 112b are at different heights, the axial segment extending between the handle 102 and the gripper 112 (the proximal portion of the balloon shaft 106 and the inner shaft 108) may bend. This, in turn, increases friction between the axial segment and the proximal opening of the handle, making it more difficult for the handle and gripper to move relative to each other in the axial direction (proximal and distal). Because surfaces 102b and 112b are coplanar or substantially coplanar, when placed on a working surface (e.g., an operating table or a patient's thigh), deflection of the axial segment between the handle and the gripper is prevented or minimized. This reduces the manual push and pull required to move these components relative to each other (proximal and distal) and improves control over dislodgement of the prosthetic valve 10.

[0094] According to one embodiment, the lower surfaces 112b and 102b are considered substantially coplanar when the vertical distance (H1) from the central longitudinal axis 106a of the balloon shaft 106 to the bottom surface 112b of the gripper 112 is substantially equal to the vertical distance (H2) from the central longitudinal axis 104a of the outer shaft 104 to the bottom surface 102b of the handle 102. Distances (H1) and (H2) are considered substantially the same if, in some instances, the difference between (H1) and (H2) is less than 5% of (H2), and in some instances, even more desirablely, less than 1% of (H2). In a specific embodiment, the central longitudinal axis 106a of the balloon shaft 106 coincides with the central longitudinal axis 104a of the outer shaft 104 (i.e., shafts 104 and 106 are coaxial).

[0095] When the handle 102 and the clamp 112 are placed on a work surface and axially moved relative to each other, substantially the same height (Hi) and (H2) can ensure that the balloon shaft 106 and the outer shaft 104 remain substantially coaxial. Otherwise, if (Hi) is substantially different from (H2), the shaft segments between the handle and the clamp can bend, which can increase the sliding friction between the shafts and increase the resistance to axial movement.

[0096] Figure 11 is an exploded view of some components of the handle 102 and the clamp 112 according to one embodiment. As shown, the handle 102 has a housing 154, which can include two half-housings 154a, 154b, each of which can have a generally half-cylindrical shape. The housing 154a can have a longitudinal edge configured to matingly engage a corresponding longitudinal edge of the housing 154b to form a clamshell configuration. The housing 154 can define a lumen 156 through which the balloon shaft 106 extends.

[0097] As shown, the handle 102 can have a hub 158 disposed within a distal end portion of the lumen 156. The proximal end 104p of the outer shaft 104 can be fixedly coupled to a distal end of the hub 158. The balloon shaft 106 can extend through a lumen of the hub 158 and a lumen of the outer shaft 104. An O-ring (not shown) can be placed on the balloon shaft 106 at or within the proximal end of the hub 158 to seal any gap between an outer surface of the balloon shaft 106 and the lumen of the hub 158. A one-way valve 162 can be fluidly connected to the lumen of the hub 158. The one-way valve 162 can have a port 164 (see Figures 10A-10B extending outside the housing 154 through an opening on one of the half-housings. Thus, through the port 164, flush fluid can be injected through the valve 162 into the lumen of the hub 158 and further into the lumen of the outer shaft 104, thereby flushing the outer surface of the balloon shaft 106.

[0098] The lock member body 152 of the locking mechanism 150 can be disposed within a proximal end portion of the lumen 156 of the handle 102. The lock member body 152 can include a cylindrical portion 168 and a user-engageable tab 166 extending radially outward from the cylindrical portion 158. The tab 166 can extend into and be rotatably movable within a recessed or cut-out region 169 at the proximal end portion of the handle 102 (see Figures 10A-10B ).

[0099] The locking mechanism 150 can further include a collet 170 at least partially received within a lumen 178 of the lock member body 152. For example, in Figure 11In the depicted embodiment, the collet 170 includes a star-shaped end plate 172 having a plurality of radial protrusions 171, a neck 174 extending proximally from the end plate 172, and a plurality of cantilevered arms 176 (two are shown in the depicted example) extending proximally from the neck 174. As Figure 12 and Figure 12A As shown, the arms 176 and the neck 174 of the collet 170 can be disposed within a cavity 178 of the lock body 152. The cavity 178 has a proximal portion 178p and a distal portion 178d. The cavity 178 has a tapered shape such that the proximal portion 178p has a smaller diameter than the distal portion 178d. Each protrusion 171 can abut a respective inner surface portion of the handle, which allows the collet 170 to axially slide within the handle but prevents rotational movement of the collet relative to the handle.

[0100] The delivery apparatus 100 can further include another shaft, such as a hypotube 182, which can be made of a metallic or alloy material and desirably more rigid and has a higher kink resistance than the balloon shaft 106. As shown, Figures 11-12 The hypotube 182 can at least surround a proximal portion of the balloon shaft 106 and extend through the collet 170 and the lock body 152. A proximal end of the hypotube 182 can be connected to the gripper 112. In particular, the hypotube 182 can extend through an opening 173 in the end plate 172 and a cavity of the neck 174 such that the plurality of arms 176 of the collet 170 can be coaxially disposed around the hypotube 182.

[0101] An inner surface of the lock body defining the cavity 178 can have a plurality of internal threads 181. The neck 174 of the collet 170 can have a corresponding external thread 180 configured to threadably engage the internal threads 181 of the lock body 152. According to one embodiment, rotation of the lock body 152 about its central axis can cause a corresponding axial movement of the collet 170 relative to the lock body 152 and the hypotube 182. Movement of the collet 170 can be caused by the engagement of the threads 180, 181 with each other and by the radial protrusions 171 of the end plate 172 engaging the corresponding inner surface of the interface housing 154 to prevent rotational movement of the collet 170 but allow its axial sliding. For example, rotating the lock body 152 in a first direction (e.g., toward a locked position) can cause the collet 170 to move in a proximal direction, while rotating the lock body 152 in a second direction opposite the first direction (e.g., toward an unlocked position) can cause the collet 170 to move in a distal direction.

[0102] According to one embodiment, when the lock body 152 is in the locked position (L), the distal portions of the arms 176 are urged into the narrower proximal portion 178p of the lock cavity 178. As a result, the arms 176 can be elastically compressed radially inward to clasp or grip the hypotube 182. Because the proximal end of the hypotube 182 is connected to the collet 112, gripping the hypotube 182 can prevent axial movement between the handle 102 and the collet 112. When the lock body 152 is in the unlocked position (U), the distal portions of the arms 176 move into the wider distal portion 178d of the lock cavity 178. As a result, the elastically compressed arms 176 can expand radially outward, thus releasing their grasp on the hypotube 182, allowing axial movement of the hypotube relative to the collet and axial movement between the collet 112 and the handle 102.

[0103] As shown in Figure 16 and Figure 16A , the hypotube 182 can have a flared distal portion 184 having an enlarged diameter relative to the remainder of the hypotube. The diameter of the flared portion 184 can be greater than the diameter of the opening 173 in the end plate 172 of the collet 170. Thus, when the collet 112 is moved in the proximal direction away from the handle 102 (and when the lock body 152 is in the unlocked position), movement of the collet 112 is prevented when the flared portion 184 abuts the end plate 172 of the collet 170, as best shown in Figure 15B . In this manner, the end plate 172 can act as a hard stop for the hypotube 182 to prevent over-movement of the collet 112 in the proximal direction relative to the handle 102.

[0104] In the depicted embodiment, the flared portion 184 is located at the distal end of the hypotube 182. In other embodiments, the flared portion 184 can be located at a position proximate to the distal end of the hypotube 182 (e.g., at the intermediate section). The distance between the flared portion 184 and the collet 112 is selected to determine how far the collet 112 can be moved axially in the proximal direction away from the handle 102. In one particular embodiment, the distance between the flared portion 184 and the collet 112 is equal to or greater than the axial distance (D1) between the distal end 138d of the valve sheath 138 and the engagement end 111 of the nosecone 110 when the valve sheath 138 is in the uncovered position (see, e.g., Figure 3 ). In one specific embodiment, the distance between the flared portion 184 and the collet 112 is approximately equal to the sum of the distance between the end plate 172 and the proximal end 114 of the handle 102 and the axial distance (D1) between the distal end 138d of the valve sheath 138 and the engagement end 111 of the nosecone 110 when the valve sheath 138 is in the uncovered position (see, e.g., Figure 3 ).

[0105] In certain instances, the middle section of the hypotube 182 can have a visually perceptible marker band 183 (see Figure 11 ) applied thereon. In certain instances, the marker band 183 can be laser edged onto the hypotube 182. In certain instances, the marker band 183 can be painted onto the hypotube 182. In certain instances, the marker band 183 can be taped and / or glued onto the hypotube 182.

[0106] The marker band 183 can be positioned on the hypotube 182 such that the appearance of the marker band 183 in the gap between the clamp 112 and the handle 102 indicates full capture or resheathing of the balloon 126, as further described below. In other words, when the clamp 112 is in contact with or in close proximity to the handle 102 (e.g., the gap between the clamp 112 and the handle 102 is less than a predetermined distance), at least a portion of the balloon 126 is not covered by the valve sheath 138, and the marker band 183 is hidden by the handle 102 and cannot be observed. As the clamp 112 is moved in the proximal direction away from the handle 102, the gap between the clamp 112 and the handle 102 increases. When the proximal movement of the clamp 112 causes the balloon 126 to be fully covered by the valve sheath 138, the marker band 183 moves out of the handle 102 and can be observed in the gap, providing a visual confirmation that the balloon is fully covered by the sheath 138.

[0107] In some embodiments, the locking mechanism 150 can further include one or more detent elements 186 in the form of protrusions protruding from a proximal face 185 that defines the recessed area 169 at the proximal end portion of the handle 102. In Figure 10A the embodiment depicted in FIG. 6, two such detent elements 186a, 186b are shown, located between and in close proximity to the locked position (L) and the unlocked position (U). The two detent elements 186a, 186b are angularly spaced apart from each other. The angle between the two detent elements 186a, 186b can be between about 80° and about 180°, desirably between about 100° and about 160°, and even more desirably between about 120° and about 140° (e.g., about 130°).

[0108] The user-engageable tab 166 can be turned circumferentially by the operator to engage and / or disengage the detent elements 186 when moved between the locked and unlocked positions. In particular, see Figure 10ARotate the tab 166 in a first angular direction (clockwise in the example embodiment) over the first braking element 186a to put the tab 166 into the locked position, and rotate the tab 166 in a second angular direction opposite to the first angular direction (counterclockwise in the example embodiment) over the second braking element 186b to put the tab 166 into the unlocked position.

[0109] like Figures 15A-15B As shown, braking element 186 may be part of plunger 188, which is axially movable relative to locking body 152. Two braking elements 186a and 186b may be connected via bridging member 187. At least one biasing member may be provided to resiliently push braking elements 186a, 186b to a first position in a recessed region 169 extending further into the handle for engaging a user-engageable tab 166. For example, in an exemplary embodiment, two coiled springs 190 are coaxially disposed on a distal protrusion 191 connected to the distal side of bridge 189. The proximal ends of springs 190 bear against bridge 189, while the distal ends of springs 190 abut against adjacent surfaces inside handle 102, thereby biasing bridge 189 and braking elements 186a, 186b proximally toward tab 166.

[0110] When the user-engageable tab 166 rotates and passes one of the braking elements 186a and 186b, the tab 166 presses against the braking element and moves both braking elements further into the internal handle to resist the bias of the spring 190, reaching the second position. When the tab 166 is in the locked position, as... Figure 10A As shown, braking element 186a is in a first position and can engage one side of the tab 166. The biasing force of spring 190 is selected to prevent the tab 166 from unintentionally rotating out of the locked position until actuated by the user. Similarly, when the tab 166 is in the unlocked position, braking element 186b can engage one side of the tab 166, thereby preventing the tab from unintentionally moving out of the unlocked position until actuated by the user. To move the tab 166 from the unlocked position to the unlocked position, or vice versa, the user applies sufficient manual force to the tab 166 to overcome the bias of spring 190, which allows the tab to leave the unlocked position (or locked position) and pass the adjacent braking element.

[0111] In addition to visual indicators on the handle marking the locked and unlocked positions, engagement and disengagement between tab 166 and braking element 186 can generate additional feedback (e.g., audible clicks and / or tactile vibrations) to the operator to indicate the position of tab 166.

[0112] In some embodiments, the handle 102 can have only one detent element. For example, in one embodiment, the handle 102 has only detent element 186a for retaining the tab 166 in the locked position. In another embodiment, the handle 102 has only detent element 186b for retaining the tab 166 in the unlocked position.

[0113] In some embodiments, the handle 102 can have corresponding slots (not shown) adjacent to the locked and unlocked positions and distal to the recessed area 169. The slots can be sized and shaped to receive the tab 166 when the tab is in the unlocked or locked position. Thus, after moving the tab 166 to the locked or unlocked position, the tab 166 can slide into the corresponding slot, thereby retaining the tab 166 in place until removed from the slot by the user. In alternative embodiments, other retention mechanisms configured to prevent unintentional movement of the tab 166 from the locked or unlocked position (e.g., a clip, a clamp, a hook-and-loop fastener, etc.) can be incorporated into the handle.

[0114] As shown in FIGS. 10-13, the holder 112 can include a body portion or housing 192 and an integrated Y-connector 196 disposed inside the body portion. The body portion 192 can define a cavity through which the Y-connector 196 extends. The body portion 192 can have a proximal opening 193, a distal opening 194, and a lateral opening 195. In the depicted embodiment, the lateral opening 195 is on the top surface of the holder 112, opposite the bottom surface 112b. In other embodiments, the lateral opening 195 can be on one of the side walls of the holder 112 (i.e., between the top surface and the bottom surface). The body portion 192 can also have two flat or substantially flat side surfaces 192s (one side surface 192s is shown in FIG. 11; the other side surface 192s is on the opposite side of the holder) on opposite side walls. In certain instances, the side surfaces 192s can be textured (e.g., with grooves) so that the holder 112 can be easily gripped by two fingers of an operator. In certain instances, the bottom surface 112b of the holder can also be textured (e.g., with grooves) to resist movement when the holder 112 is placed on a flat surface. Figure 13

[0115] ​In some instances, the gripper 112 and the balloon shaft 106 are rotatable about the central longitudinal axis 106a of the balloon shaft 106. In some instances, when the gripper 112 is rotated 90 degrees (clockwise or counterclockwise) from the position shown in the figure so that the lateral opening 195 points to the sideways, one of the side surfaces 192s faces downward and can be coplanar or substantially coplanar with the bottom surface 102b of the handle 102. This can be achieved, for example, by aligning the two side surfaces 192s and the bottom surface 112b with the axial axis of the gripper (which is perpendicular to the axial axis of the balloon shaft 106). Figure 10B The gripper 112 can be equidistant from the central longitudinal axis 106a. Therefore, the gripper 112 can have three contact surfaces, namely the bottom surface 112b and two side surfaces 192s, each of which can be placed on the operating table (or other flat surface), while ensuring that such contact surfaces are coplanar or substantially coplanar with the bottom surface 102b of the handle 102.

[0116] like Figure 14 As shown, the Y-type connector 196 may have a main tube portion 197 and a side tube portion 198 extending at an angle from the main tube portion 197. The main tube portion 197 may extend through the cavity of the clamp 112 and be substantially parallel to the bottom surface 112b of the clamp 112. In the depicted embodiment, the distal portion 197d of the main tube portion 197 is positioned adjacent to the distal end 112d of the clamp 112, and the proximal portion 197p of the main tube portion 197 extends out of the proximal opening 193 of the clamp 112. The side tube portion 198 may extend through the lateral opening 195 of the clamp 112.

[0117] According to one embodiment, the proximal ends of the balloon shaft 106, inner shaft 108, and hypotube 182 are all fixedly coupled to the main tube portion 197 of the Y-connector 196. In other embodiments, the proximal ends of all the balloon shaft 106, inner shaft 108, and hypotube 182 may be fixedly coupled to the housing 192 of the holder 112. However, in an alternative embodiment, the proximal end of hypotube 182 may be fixedly coupled to the main body portion 192, the proximal end of the inner shaft 108 may be fixedly coupled to the main tube portion 197, and the proximal end of the balloon shaft 106 may be fixedly coupled to either the main body portion 192 or the main tube portion 197.

[0118] The proximal end of the main tube portion 197 has an opening through which a guidewire can be inserted into the cavity of the main tube portion 197. As described above, the guidewire can also extend through the cavities of the nasal cone 110 and the inner shaft 108.

[0119] The side tube portion 198 is fluidly coupled to the lumen of the balloon shaft 106. Thus, the side tube portion 198 can serve as a balloon inflation port through which inflation fluid can be injected (e.g., via a syringe) into the balloon shaft 106. In some embodiments, a source of inflation fluid, such as a syringe, can be fluidly coupled to the inflation portion 198 by a medical tube known in the art. As described above with reference to the delivery device 100, the injected inflation fluid can flow through the annular space 128 between the balloon shaft 106 and the inner shaft 106 and into the balloon 126, thereby inflating the balloon 126. Conversely, the injected inflation fluid can be withdrawn (e.g., by a syringe) from the side tube portion 198 to deflate the balloon 126. Figure 5 As described above, the injected inflation fluid can flow through the annular space 128 between the balloon shaft 106 and the inner shaft 106 and into the balloon 126, thereby inflating the balloon 126. Conversely, the injected inflation fluid can be withdrawn (e.g., by a syringe) from the side tube portion 198 to deflate the balloon 126.

[0120] Figure 17 A delivery device 200 according to another embodiment is shown, which can be used to deliver a prosthetic valve, such as the prosthetic valve 10. Similar to the delivery device 100, the delivery device 200 can include a handle 202, an outer shaft 204 connected to a distal end of the handle 202, an intermediate or balloon shaft 206 extending through a lumen of the outer shaft 204, an inner shaft 208 extending through a lumen of the balloon shaft 206, and a nose cone 210 connected to a distal end of the inner shaft 208. Similarly, the delivery device 200 can include a gripper 212 located proximally of the handle 202 and axially movable relative to the handle 202. Also, the delivery device 200 can include a valve sheath 238 connected to a distal end of the outer shaft 204 and configured to cover the prosthetic valve 10 when the prosthetic valve is compressed on a balloon along a distal portion of the delivery device 200. In addition, the delivery device 200 can include a tandem introducer 215 including a sheath 216 and a hub 218. The outer shaft 204 can extend through the tandem introducer 215 and can be axially movable relative to the introducer 215.

[0121] In contrast to delivery device 100, which has Y-connector 196 disposed within gripper 112, delivery device 200 has Y-connector 296 separate from (disposed outside of) gripper 212. In addition, in contrast to delivery device 100, which has locking mechanism 150 integrated into handle 102, delivery device 200 can have removable locking member 250 as a separate component from handle 202. For example, locking member 250 can have a pair of resilient prongs 252 that are slightly less than the diameter of balloon shaft 206 apart from one another. Thus, by placing prongs 252 of locking member 250 against shaft 206 and firmly pressing locking member 250 against shaft 206, prongs 252 will splay apart and slide along opposite sides of the shaft until shaft 206 is between prongs 252. In this manner, prongs 252 form a snap-fit connection with shaft 206. Once placed over the shaft, prongs 252 frictionally engage the outer surface of the shaft and resist axial movement of the locking member along the length of the shaft. Thus, when locking member 250 is on the shaft, distal movement of shaft 206 and gripper 212 relative to handle 202 is limited by contact between locking member 250 and the proximal end of handle 202. Locking member 250 can be removed from shaft 206 manually by pulling the locking member away from the shaft in a transverse direction (i.e., perpendicular to the length of shaft 206).

[0122] In some embodiments, delivery device 200 can include a hypotube (e.g., hypotube 182) extending over balloon shaft 206, similar to hypotube 180 of delivery device 100, in which case locking member 250 can be placed over the hypotube to limit distal movement of the hypotube and balloon shaft 206.

[0123] Prior to insertion into a patient, prosthetic valve 10 can be crimped around balloon and delivery sheath 238 can be advanced over the prosthetic valve so that it abuts nosecone 210 (similar to Figure 2The locking member 250 can then be placed on the shaft 206 proximal to the handle 202. In this position, the locking member 250 can prevent distal movement of the shaft 206 and the prosthetic valve 10 relative to the handle 202 and the delivery sheath 238 and / or proximal movement of the handle 202 and the delivery sheath 238 relative to the shaft 206 and the prosthetic valve 10 to prevent premature advancement of the prosthetic valve 10 from the delivery sheath 238. The prosthetic valve 10 and the distal end portion of the delivery device 200 can then be inserted into the patient’s vasculature and advanced to the implantation site. When the prosthetic valve is at or near the implantation site, the locking member 250 can be removed from the shaft 206. Thereafter, the user can advance the prosthetic valve 10 from the delivery sheath 238 by pushing the gripping 212 distally relative to the handle 202 and / or pulling the handle 202 proximally relative to the gripping 212.

[0124] In some embodiments, the prosthetic valve 10 can be mounted in a compressed state on the distal end of the delivery device 100 (or 200) and advanced through the patient’s vasculature (e.g., through the femoral artery and the aorta) until the prosthetic valve 10 reaches the target implantation site in the heart. The prosthetic valve 10 can then be expanded to its functional size by inflating the balloon on which it is mounted.

[0125] In another embodiment, a docking device or docking station can be implanted first at the target implantation site. The docking device can then provide a landing zone into which the prosthetic valve 10 can be deployed, as described below. This approach can be particularly helpful for transcatheter implantation of a prosthetic valve at a site having a large annulus, where the prosthetic valve can not be large enough to expand sufficiently inside the native valve or other implantation or deployment site to secure in place. One such example is replacement of a pulmonary valve, which presents a significant challenge because the pulmonary artery can have a wide variety of different shapes and sizes. These differences can be even more pronounced in pulmonary arteries that are compromised due to certain conditions and / or prior surgeries. For example, treatment of tetralogy of Fallot (TOF) or transposition of the great arteries (TGA) often results in a larger and more irregularly shaped pulmonary artery.

[0126] Figure 18One example embodiment of a docking device 300 is shown, which is configured to receive another transcatheter device, such as transcatheter prosthetic valve 10. Docking device 300 includes an expandable frame 302, which is shown in its unconstrained, expanded condition. When expanded, frame 302 can be configured or shaped to conform to the interior shape of a portion of the vasculature in which it is to be implanted, such as the pulmonary annulus. Frame 302 is desirably a wide stent composed of a plurality of metal struts 310 forming cells 312. Docking device 300 can include one or more sealing members 316 (see Figure 19 ), which can be made of fabric, polymer, or other covering and attached to a portion of frame 302. Sealing members 316 can be configured to contact the interior surface of the circulatory system at the implant site to inhibit or prevent paravalvular leakage.

[0127] Expandable frame 302 can be made of a highly elastic or compliant material to accommodate large variations in anatomy. For example, frame 302 can be made of a highly flexible metal, metal alloy, polymer, or open cell foam. One example of a highly elastic metal is Nitinol, although other metals and highly elastic or compliant non-metallic materials can also be used. In the depicted embodiment, frame 302 is self-expandable. In other embodiments, the frame can be manually expanded (e.g., by balloon expansion), or mechanically expanded. Self-expandable frame 302 can be made of a shape memory material (e.g., Nitinol).

[0128] Docking device 300 can also optionally include one or more valve seats 318 configured to receive and support transcatheter prosthetic valve 10 after docking device 300 is implanted in the circulatory system. Valve seats 318 can be attached to frame 302 or integrally formed with frame 302. In addition, docking device 300 can include one or more retention members 320, which can be any structure that sets the position of docking device 300 in the circulatory system. In some embodiments, retention members 320 can be part of or define a sealing portion of frame 302 and / or docking device 300. In some embodiments, retention members 320 can be separate components attached to frame 302 of docking device 300. In the depicted example, retention members 320 include the free ends of metal struts 310 at proximal inflow end 305 and distal outflow end 307 of frame 302. For example, retention members 302 can press against or into the interior surface or contour / extend around the anatomy of the circulatory system to set and maintain the position of docking device 300.

[0129] In the depicted example, when fully expanded, the frame 302 can have an hourglass shape defined by a relatively wide proximal inflow portion 304 and distal outflow portion 306, and a relatively narrow waist portion 308 between the inflow portion 302 and the outflow portion 304. In certain embodiments, the narrow waist portion 308, when covered by an impermeable material, can form a valve seat 318, and the prosthetic valve 10 can be expanded in the narrow waist portion 308. The frame 302 can also include one or more retention tabs 314 extending from the inflow end 305 (or optionally from the outflow end 307), which can be releasably connected to a retention member of a delivery catheter, as described below.

[0130] The illustrated docking device 300 and prosthetic valve 10 are particularly suited for deployment in the pulmonary artery or right ventricular outflow tract for pulmonary valve replacement. However, the docking device 300 and prosthetic valve 10 can be deployed in any internal surface within the heart or body lumen. For example, the various docking devices and valves described herein can be deployed in the superior vena cava, inferior vena cava, tricuspid valve, mitral valve, aortic valve, aorta, or other vasculature / lumens in the body. Further details regarding docking devices are disclosed in U.S. Patent Publication Nos. 2017 / 0231756 and 2019 / 0000615, which are incorporated by reference herein.

[0131] As one example, Figure 19 A prosthetic valve 10 is shown received within the docking device 300, which is implanted in the circulatory system, such as in the pulmonary artery. In the depicted embodiment, a sealing member 316 provides a seal between the docking device 300 and the internal surface 70 of the circulatory system. The sealing member 316 can be formed by providing a blood impermeable material (e.g., PET cloth) over the frame 302 or a portion thereof. In particular embodiments, the sealing member 316 can cover the lower (proximal to the inflow end 305), circular, radially outwardly extending portion 322 of the frame 302. In exemplary embodiments, the sealing member 316 can extend from at least the portion 322 of the frame 302 to the valve seat 318. This makes the docking device 300 impermeable from the portion 322 to the valve seat 318. As such, all blood flowing in a direction from the inflow end 305 toward the outflow end 307 is directed to the valve seat 318 (and the prosthetic valve 10 once installed or deployed in the valve seat 318).

[0132] In certain embodiments, the wall at the inflow portion 304 of the docking device 300 is blood impermeable, but the wall at the outflow portion 306 is relatively open. In one embodiment, the inflow portion 304, the waist portion 308, and a portion of the outflow portion 306 are covered with a blood impermeable fabric that can be sewn to the frame 302 or otherwise attached by methods known in the art. The impermeability of the inflow portion 304 of the frame 302 can help funnel blood flow into the docking device 300 and ultimately through the valve 10 to be expanded and secured within the docking device 300.

[0133] Viewed from another perspective, this embodiment of the docking device is designed to seal at the proximal inflow portion 304 to form a conduit for blood flow. However, at least some of the distal rows of cells 312 can remain open and form a permeable portion 324, allowing the docking device 300 to be placed at a higher location in the pulmonary artery without restricting blood flow. For example, the distal permeable portion can extend into branches of the pulmonary artery and not impede or significantly impede blood flow through the branches. In one embodiment, a blood impermeable cloth (e.g., PET cloth) or other material covers the proximal inflow portion 304, but the covering does not cover any or at least a portion of the distal outflow portion 306. As one non-limiting example, when the docking device 300 is placed in the pulmonary artery, which is a large blood vessel, a large amount of blood flowing through the artery passes through the narrow space into the valve 10 through the sealing member 316. The sealing member 316 is fluid impermeable, so blood cannot pass through. Again, a variety of other biocompatible covering materials can be used, such as foam or fabric treated with a coating that is impermeable to blood, polyester, or a processed biological material such as pericardium.

[0134] Valve seat 318 can provide a support surface for implanting or deploying prosthetic valve 10 in docking device 300. Retention member 320 can retain docking device 300 in an implantation position or deployment site in the circulatory system. For example, example retention member 320 has an outwardly curved flared portion that helps secure docking device 10 within the pulmonary artery. In the depicted embodiment, when docking device 300 is compressed by inner surface 70, retention member 320 can engage surface 70 at an angle a (between the normal direction of surface 70 and the tangent of retention member 320), which can range between about 30 and 60 degrees, such as about 45 degrees. This inward curvature of retention member 320 serves to retain docking device 300 in the circulatory system. Retention member 320 is at the wider inflow end 305 and outflow end 307 and presses against inner surface 70. The flared retention member 320 can engage into the surrounding anatomy in the circulatory system, such as in the pulmonary space. In one example embodiment, the flared portion acts as a brake to lock the device 300 in place. When an axial force is applied to docking device 300, the flared retention member 320 is pushed by the force into the surrounding tissue to resist migration of docking device 300.

[0135] Figure 20 An example embodiment of a delivery apparatus 400 for delivering and deploying docking device 300 is shown. Delivery apparatus 400 can take a variety of different forms. In the example instance, delivery apparatus 400 includes a handle 402, an outer shaft 404 connected to handle 402, an inner shaft 406 extending through a lumen of outer shaft 404, a docking device retention member 408 connected to inner shaft 406, and a nosecone 410 connected to docking device retention member 408 by a connecting tube 412. Outer shaft 404 can be moved axially relative to inner shaft 406 by a rotational drive member 414 (e.g., a rotatable knob) located on handle 402, for example. A distal portion 416 of outer shaft 404 can form a delivery sheath or capsule configured to extend over docking device 300 during delivery. In addition, a guidewire 420 (see Figure 21A ) can extend through a lumen of inner shaft 406 and nosecone 410 so that inner shaft 406 and outer shaft 404 can be routed over the guidewire to position docking device 300 at an implantation site.

[0136] In the delivery configuration, docking device 300 can be disposed along a distal portion of inner shaft 406 and retained in a compressed configuration by delivery sheath 416, which extends over the radially compressed docking device. Retention tabs 314 of frame 302 can be releasably connected to docking device retention member 408 (see Figure 20A). The radio-opaque marker 418 can be placed on the outer surface of the delivery sheath or embedded within the wall of the delivery sheath along the delivery sheath 416. The outer shaft 404 can be gradually retracted in the proximal direction (e.g., by actuating the drive member 414) relative to the inner shaft 406, the retention member 408, and the nosecone 410 to deploy the docking device 300, as described below. Further details regarding the delivery apparatus 400 and methods for implanting the docking device 300 are disclosed in U.S. Patent Publication Nos. 2017 / 0231756 and 2019 / 0000615.

[0137] Figures 21A-21H Certain steps are illustrated for implanting the docking device 300 and the prosthetic valve 10 at the right ventricular outflow tract (RVOT) for pulmonary valve replacement in accordance with one embodiment.

[0138] Figure 21A A guidewire 420 is shown inserted through the vasculature of a patient into the pulmonary bed. Specifically, the guidewire 420 can be advanced through the femoral vein, inferior vena cava, right atrium, tricuspid valve, right ventricle, and right ventricular outflow tract to the pulmonary artery 50. Under fluoroscopy, a delivery apparatus 400 (only the outer shaft 404 and the nosecone 410 are shown) holding the docking device 300 can be delivered over the guidewire 420. The delivery apparatus 400 can be advanced until the radio-opaque marker 418 is positioned at the distal end of the intended landing zone 60 where the docking device 300 is to be deployed.

[0139] The outer shaft 404 can then be gradually retracted relative to the inner shaft 406 (e.g., by rotating the drive member 414 in a first direction) to deploy the docking device 300, as shown. Figure 21B When the distal portion of the docking device 300 becomes uncovered by the outer shaft 404, the distal portion of the frame 302 begins to self-expand. The distal half of the frame 302 is fully expanded at the intended landing zone 60 when the radio-opaque marker 416 is located near the waist portion 308 of the frame 302. The deployment location of the docking device 300 can be reevaluated as the frame portion expands. If the docking device 300 needs to be repositioned, the distal portion of the frame 302 can be compressed and recaptured by the delivery sheath 416 of the outer shaft 404. This can be accomplished by, for example, moving the outer shaft 404 distally (e.g., by rotating the drive member 414 in a second direction opposite the first direction) until it contacts the nosecone 410. The radio-opaque marker 418 can then be repositioned relative to the intended landing zone 60 to redeploy the docking device 300.

[0140] Further retraction of the outer shaft 404 past the waist portion 308 can release the proximal half of the frame 302 from the delivery sheath 416. When the outer shaft 404 is retracted to a position that exposes the retention tabs 314, the retention tabs 314 can release from the docking device retention member 408 due to the expansion force of the frame 302. Thus, asFigure 21C As shown, frame 302 can be fully expanded and frictionally engage the inner wall of the pulmonary artery (or right ventricular outflow tract), i.e., docking device 300 is fully deployed at the intended landing area 60.

[0141] like Figure 21D As shown, after deploying the docking device 300 at the intended landing area 60, the delivery device 400 can be retracted from the patient's vascular system via the guidewire 420, while leaving the guidewire 420 in place. After withdrawing the delivery device 400 from the patient's vascular system, the prosthetic valve 10 can then be delivered to and received by the docking device 300 via the delivery device 100, as described below (although the delivery device 100 is described as an example, a similar procedure can be performed using the delivery device 200).

[0142] Before implantation of the prosthetic valve 10, the prosthetic valve 10 can be rolled up on the balloon 126 and covered by the valve sheath 138 of the delivery device 100 (see example). Figure 1 For pulmonary valve implantation, the prosthetic valve 10 is oriented such that when the valve 10 is rolled up on the valve retaining portion 130 of the balloon 126, its inflow end 22 is located proximal to the outflow end 24 (see example). Figure 4B The clamp 112 and handle 102 are axially separated from each other until the distal end 138d of the valve sheath 138 contacts the engagement end 111 of the nasal cone 110, such that the valve sheath 138 completely covers the prosthetic valve 10. Then, the locking body 152 on the handle 102 can be rotated to a locked position, preventing the handle 102 and clamp 112 from moving axially relative to each other. Therefore, the nasal cone 110 and valve sheath 138 are locked together during navigation through the patient's vascular system.

[0143] In one example implementation, the nasal cone 110, valve sheath 138, and sheath 116 of the tandem guide 115 are inserted together as a single unit on the guidewire 420 into the patient's vascular system (e.g., through a surgical opening in the femoral vein), with the distal end 116d of the sheath 116 preferably adjacent to or adjacent to the proximal end 138p of the valve sheath 138.

[0144] After the sheath 116 is fully inserted into the vascular system (with the hub 118 remaining outside the patient), the hub 118 can be secured in place relative to the patient and / or the operating table (e.g., by clamping or other means). Thereafter, the shafts 104, 106, 108 of the delivery device 100 can be advanced over the guidewire 420 and relative to the sheath 116 through the patient's vascular system (e.g., by pushing the outer shaft 104 or handle 102) until the valve sheath 138 is positioned at the intended landing area 60 marked by the pre-implanted docking device 300, as shown. Figure 21EAs shown. Because the handle 102 is locked and cannot move relative to the gripper 112, the outer shaft 104 (which is connected to the handle) and the valve sheath 138 (which is connected to the outer shaft 104) cannot move axially relative to the balloon shaft 106 and the inner shaft 108 (both connected to the gripper). Therefore, during advancement, the prosthetic valve 10 remains covered by the valve sheath 138 to prevent damage to the prosthetic valve, as well as the inner wall of the vascular system and the tricuspid valve chordae tendineae.

[0145] Upon reaching the intended landing zone 60, the delivery device 100 can be manipulated to place the prosthetic valve 10 within the waist 308 region of the docking device 300. This can be confirmed, for example, based on a fluoroscopic view, by aligning the radiopaque marker 136 of the delivery device 100 with the center (i.e., the narrowest part) of the waist region 308.

[0146] Then, as Figure 21F As shown, the outer shaft 104 and the valve sheath 138 connected thereto can retract proximally to uncover the prosthetic valve 10. To retract the outer shaft 104 and valve sheath 138, the locking body 152 on the handle 102 can be rotated to the unlocked position, allowing the handle 102 and the clamp 112 to move axially relative to each other. Thus, by moving the handle 102 proximally while keeping the clamp 112 stationary (thereby maintaining the position of the balloon shaft 106), the outer shaft 104 and valve sheath 138 can retract proximally relative to the balloon shaft 106 and the prosthetic valve 10. The retraction of the outer shaft 104 and valve sheath 138 can continue until the proximal end 114 of the handle 102 abuts the distal end 112d of the clamp 112, thereby moving the valve sheath 138 to the uncovered position and the prosthetic valve 10 is completely uncovered. Alternatively, the prosthetic valve 10 can be deployed from the valve sheath 138 by pushing the holder 112 distally relative to the handle 102.

[0147] like Figure 21G As shown, after the prosthetic valve 10 is no longer covered by the valve sheath 138, the balloon 126 can be inserted, for example, by injecting expansion fluid into the balloon shaft 106 (e.g., through the balloon expansion port 198, as shown). Figure 14The inflation of the balloon 126 can cause radial expansion of the prosthetic valve 10 inside the docking device 300. In some embodiments, a slow, controlled inflation of the balloon 126 can be administered during the initial deployment of the prosthetic valve 10 to improve the stability of the delivery system and the prosthetic valve 10. The fully expanded prosthetic valve 10 can be received by the docking device 300. The position of the prosthetic valve 10 can be verified under fluoroscopy. If repositioning is needed, the handle 102 and the clamp 112, which can be held together as a single unit (i.e., they remain in contact with each other), can be manipulated to slightly adjust the position and / or angle of the balloon shaft 106 and the prosthetic valve 10 as needed to ensure a safe fit between the prosthetic valve 10 and the docking device 300.

[0148] As shown in FIG. 6, after the prosthetic valve 10 is fully expanded and securely docked to the docking device 100, the balloon 126 can be deflated, e.g., by withdrawing the inflation fluid from the balloon 126 and the balloon shaft 106. The shafts 104, 106, 108 of the delivery apparatus 100 can be retracted over the guidewire 420 into the vena cava while maintaining contact between the handle 102 and the clamp 112. The deflated balloon 126 can then be resheathed (i.e., captured or covered) by the valve sheath 138. Figure 21H Resheathing of the balloon 126 can be achieved, for example, by moving the clamp 112 in the proximal direction while keeping the handle 102 stationary until the engagement end 111 of the nosecone 110 abuts the distal end 138d of the valve sheath 138. As described above, the distance between the flare portion 184 and the clamp 112 is desirably equal to or greater than the axial distance (Dl) between the distal end 138d of the valve sheath 138 and the engagement end 111 of the nosecone 110 when the valve sheath 138 is in the uncovered position (see, e.g., FIG. 5).

[0149] Figure 3 ) of the handle 102 (see, e.g., FIG. 5), this indicates that the engagement end 111 of the nosecone 110 is in contact with the distal end 138d of the valve sheath 138, i.e., the balloon 126 is fully covered by the valve sheath 138. In addition to or instead of relying on the engagement between the flare portion 184 and the end plate 172, observing the marker band 183 in the gap between the clamp 112 and the handle 102 can also indicate the end of the hypotube travel and provide a visual confirmation of the balloon being fully resheathed. The resheathed balloon 126 can facilitate smooth retraction of the delivery apparatus 100 and prevent damage to the inner walls of the vasculature and the tricuspid valve chordae during retraction. Figure 15B

[0150] ​​After resheathing the balloon 126, the shafts 104, 106, 108 of the delivery apparatus 100 can be further retracted as a single unit until the proximal end 138p of the valve sheath 138 abuts the distal end 116 of the sheath 116 (see, e.g., FIG. 1 1). The entire delivery apparatus 100, including the shafts 104, 106, 108 and the sheath 116, can then be retracted together out of the patient’s vasculature. The guidewire 420 can then also be removed. Figure 8 ) The entire delivery apparatus 100, including the shafts 104, 106, 108 and the sheath 116, can then be retracted together out of the patient’s vasculature. The guidewire 420 can then also be removed.

[0151] General Considerations

[0152] It will be appreciated that the disclosed embodiments can be adapted for delivery and implantation of the prosthetic device in any native valve annulus of the heart (e.g., the pulmonary annulus, the mitral annulus, and the tricuspid annulus), and can be used with any of the delivery approaches (e.g., retrograde, antegrade, transseptal, transventricular, transatrial, etc.).

[0153] For the purposes of this description, certain aspects, advantages, and novel features of the embodiments of the present disclosure are described herein. The disclosed methods, devices, and systems should not be construed as limiting in any manner. Instead, the present disclosure is directed to all novel and non-obvious features and aspects of the various disclosed embodiments alone, and in various combinations and sub-combinations with each other. The methods, devices, and systems are not limited to any particular aspect or feature or combination thereof, nor do the disclosed embodiments require the presence of any one or more of the specific advantages or solve any particular problem.

[0154] While the operations of some disclosed embodiments are described in a particular, sequential order for convenience, it should be understood that this manner of description encompasses reordering unless a particular ordering is required under the specific circumstances. For example, depending on the implementation, operations described sequentially can be re-arranged or performed concurrently. Further, for simplicity of explanation, the drawings can not show the various ways in which the disclosed methods can be used in conjunction with other methods. Additionally, the description sometimes uses terms like “provide” or “achieve” to describe the disclosed methods. These terms are high-level abstractions of the actual operations that are performed. The actual operations that correspond to these terms can vary depending on the particular implementation and are readily discernible by one of ordinary skill in the art.

[0155] As used in this application and in the claims, the singular forms “a,” “an,” and “the” include the plural forms unless the context clearly dictates otherwise. Additionally, the term “includes” means “comprises.” Furthermore, the term “coupled” and “connected” generally mean electrically, electromagnetically, and / or physically (e.g., mechanically or chemically) coupled or linked and does not exclude the presence of intermediate elements between coupled or associated items absent specific contrary language.

[0156] As used herein, the term “proximal” refers to a position, orientation, or portion of a device that is closer to a user and further from an implantation site. As used herein, the term “distal” refers to a position, orientation, or portion of a device that is further from a user and closer to an implantation site. Thus, for example, proximal movement of a device is movement of the device away from an implantation site and toward a user (e.g., out of a patient’s body), while distal movement of a device is movement of the device away from a user and toward an implantation site (e.g., into a patient’s body). Unless otherwise specifically defined, the terms “longitudinal” and “axial” refer to an axis that extends in the proximal and distal directions.

[0157] Directions and other related references (e.g., inner, outer, upper, lower, etc.) can be used to facilitate discussion of the drawings and principles herein, but are not intended to be limiting. For example, certain terms can be used such as “inner,” “outer,” “upper,” “lower,” “interior,” “exterior,” etc. Such terms are used where applicable to provide some clarity of description in relation to the relevant relationship, particularly with respect to the illustrated embodiments. However, such terms are not intended to suggest absolute relationships, positions, and / or orientations. For example, with respect to an object, an “upper” portion can become a “lower” portion simply by turning the object over. Nonetheless, it is still the same portion, the object is still the same. As used herein, “and / or” means “and” or “or,” as well as “and” and “or.”

[0158] As used herein, two lengths are considered substantially the same if the difference between the two lengths is less than 10% of the average of the two lengths.

[0159] Other Examples of the Disclosed Technology

[0160] In view of the above-described embodiments of the disclosed subject matter, the following enumerated examples are disclosed. It should be noted that examples of a single feature or combination of features of a separate example and, optionally, in combination with one or more features of one or more further examples, are also further examples falling within the disclosure of the present application.

[0161] Example 1. A delivery apparatus for implanting a prosthetic valve, comprising: a handle; a first shaft extending from a distal end of the handle; a second shaft extending through a lumen of the first shaft and the handle; and a gripper located proximal to a proximal end of the handle; wherein a proximal end of the second shaft is connected to the gripper, and the gripper is axially movable relative to the handle such that axial movement of the gripper causes a corresponding axial movement of the second shaft relative to the first shaft; wherein the gripper has a bottom surface that is substantially coplanar with a bottom surface of the handle.

[0162] Example 2. The delivery apparatus of any example herein, particularly example 1, wherein a distance from a longitudinal axis of the second shaft to the bottom surface of the gripper is substantially equal to a distance from a longitudinal axis of the first shaft to the bottom surface of the handle.

[0163] Example 3. The delivery apparatus of any example herein, particularly any one of examples 1-2, wherein the first shaft comprises a proximal section, a distal section, and an intermediate section between the proximal section and the distal section, wherein the distal section is more flexible than the intermediate section, and the intermediate section is more flexible than the proximal section.

[0164] Example 4. The delivery apparatus of any example herein, particularly any one of examples 1-3, further comprising an inflatable balloon having a valve holding portion configured to mount a prosthetic valve thereon.

[0165] Example 5. The delivery apparatus of any example herein, particularly example 4, further comprising a valve sheath configured to cover the prosthetic valve when the prosthetic valve is mounted on the balloon in a radially compressed state, wherein a proximal end of the valve sheath is connected to a distal end of the first shaft.

[0166] Example 6. The delivery apparatus of any example herein, particularly example 5, wherein a distance between a proximal end of the handle and the gripper is equal to or greater than a length of the valve sheath when the prosthetic valve is covered by the valve sheath, such that upon axially moving the proximal end of the handle relative to the gripper until the proximal end of the handle contacts the gripper, a distal end of the valve sheath is located proximal to a proximal end of the prosthetic valve, thereby fully uncovering the prosthetic valve.

[0167] Example 7. The delivery apparatus of any example herein, particularly any one of examples 5-6, further comprising a third shaft extending through a lumen of the second shaft, wherein a proximal end of the third shaft is connected to the gripper and a distal end of the third shaft is connected to a nosecone.

[0168] Example 8. The delivery apparatus of any example herein, particularly example 7, further comprising a balloon shoulder assembly, wherein the balloon shoulder assembly comprises a proximal shoulder connected to a distal portion of the second shaft and a distal shoulder connected to a distal portion of the third shaft, wherein the distal shoulder and the proximal shoulder are disposed inside the balloon.

[0169] Example 9. The delivery device of any example herein, particularly example 8, wherein the third shaft includes a radiopaque marker positioned between the proximal shoulder and the distal shoulder.

[0170] Example 10. The delivery device of any example herein, particularly any of examples 7-9, wherein the proximal end of the nosecone abuts the distal end of the valve sheath when the prosthetic valve is retained within the valve sheath.

[0171] Example 11. The delivery device of any example herein, particularly any of examples 1-10, wherein the gripper includes a housing defining a bottom surface of the gripper, the gripper further including a Y-connector having a main tube portion and a side tube portion fluidly connected to and extending angularly from the main tube portion, wherein the main tube portion extends through the gripper housing and substantially parallel to the bottom surface of the gripper housing, and the side tube portion extends through an opening in a top surface of the gripper housing.

[0172] Example 12. The delivery device of any example herein, particularly example 11, wherein the proximal end of the second shaft is connected to the main tube portion of the Y-connector.

[0173] Example 13. The delivery device of any example herein, particularly any of examples 1-12, further comprising a guide installed on the first shaft, the guide including a sheath and a hub connected to a proximal end of the sheath, wherein the first shaft extends through the sheath and the hub and is axially movable relative to the sheath and the hub.

[0174] Example 14. The delivery device of any example herein, particularly any of examples 1-13, wherein the handle includes a locking mechanism, the locking mechanism including a lock body movable between a locked position and an unlocked position, wherein the second shaft and the fourth shaft are axially movable relative to the handle and the first shaft when the lock body is in the unlocked position, and wherein the second shaft and the fourth shaft are not axially movable relative to the first shaft and the handle when the lock body is in the locked position.

[0175] Example 15. The delivery device of any example herein, particularly example 14, further comprising the fourth shaft extending through the handle, wherein the proximal end of the fourth shaft is connected to the gripper and the second shaft extends through the fourth shaft.

[0176] Example 16. The delivery device of any example herein, particularly example 15, wherein the lock body includes a tab engageable by a user, wherein the locking mechanism further includes at least one detent element positioned to engage the tab when the lock body is in the locked position or the unlocked position.

[0177] Example 17. The delivery device of any example herein, particularly example 16, wherein the at least one detent element comprises a first detent element proximal to the locked position and a second detent element proximal to the unlocked position, wherein rotating the tab past the first detent element in a first angular direction aligns the tab with the locked position, and rotating the tab past the second detent element in a second angular direction aligns the tab with the unlocked position, the second angular direction being opposite the first angular direction.

[0178] Example 18. The delivery device of any example herein, particularly any of examples 15-17, wherein the locking mechanism further comprises a collet at least partially received within the lock body, wherein the collet comprises external threads that engage internal threads of the lock body and is coaxially disposed about the fourth shaft, wherein rotation of the lock body produces axial movement of the collet relative to the lock body and the fourth shaft.

[0179] Example 19. The delivery device of any example herein, particularly example 18, wherein the collet has a distal opening through which the fourth shaft extends, the fourth shaft comprising a flared portion, wherein the flared portion has a diameter that is greater than a diameter of the distal opening such that proximal movement of the fourth shaft is prevented when the flared portion abuts the collet.

[0180] Example 20. The delivery device of any example herein, particularly any of examples 15-19, wherein an inner surface of the lock body defines a lock cavity, the lock cavity having a proximal portion and a distal portion, wherein the lock cavity has a tapered shape such that the proximal portion has a smaller diameter than the distal portion.

[0181] Example 21. A delivery device for implanting a prosthetic valve, comprising: a handle; a first shaft extending from a distal end of the handle; a second shaft extending through a lumen of the first shaft and the handle; and a gripper located proximal to a proximal end of the handle; wherein a proximal end of the second shaft is connected to the gripper, and the gripper is axially movable relative to the handle such that axial movement of the gripper causes corresponding axial movement of the second shaft relative to the first shaft; wherein a distance from a longitudinal axis of the second shaft to a bottom surface of the gripper is substantially the same as a distance from a longitudinal axis of the first shaft to a bottom surface of the handle.

[0182] Example 22. The delivery device of any example herein, particularly example 21, further comprising an inflatable balloon, the balloon having a valve retention portion configured to mount a prosthetic valve thereon.

[0183] Example 23. The delivery device of any example herein, particularly example 22, further comprising a valve sheath configured to cover the prosthetic valve when the prosthetic valve is mounted on the balloon in a radially compressed state, wherein a proximal end of the valve sheath is connected to a distal end of the first shaft.

[0184] Example 24. The delivery device of any example herein, particularly Example 23, wherein the distance between the proximal end of the handle and the gripper is equal to or greater than the length of the valve sheath when the prosthetic valve is covered by the valve sheath, such that when the proximal end of the handle contacts the gripper after axially moving the handle relative to the gripper, the distal end of the valve sheath is positioned proximal to the proximal end of the prosthetic valve, thereby fully uncovering the prosthetic valve.

[0185] Example 25. The delivery device of any example herein, particularly any of Examples 22-24, further comprising a third shaft extending through a lumen of the second shaft, wherein a proximal end of the third shaft is connected to the gripper and a distal end of the third shaft is connected to the nosecone.

[0186] Example 26. The delivery device of any example herein, particularly Example 25, further comprising a balloon shoulder assembly, wherein the balloon shoulder assembly comprises a proximal shoulder connected to a distal end portion of the second shaft and a distal shoulder connected to a distal end portion of the third shaft, wherein the distal shoulder and the proximal shoulder are disposed inside the balloon.

[0187] Example 27. The delivery device of any example herein, particularly any of Examples 25-26, wherein a proximal end of the nosecone abuts a distal end of the valve sheath when the valve sheath is in the closed position.

[0188] Example 28. The delivery device of any example herein, particularly any of Examples 21-27, wherein the gripper comprises a housing defining a bottom surface of the gripper, the gripper further comprising a Y-shaped connector having a main tube portion and a side tube portion fluidly connected to and extending angularly from the main tube portion, wherein the main tube portion extends through the gripper housing and substantially parallel to the bottom surface of the gripper housing, and the side tube portion extends through an opening in a top surface of the gripper housing, wherein a proximal end of the second shaft is connected to the main tube portion of the Y-shaped connector.

[0189] Example 29. The delivery device of any example herein, particularly any of Examples 21-28, wherein the handle comprises a locking mechanism comprising a lock body movable between a locked position and an unlocked position, wherein the second shaft is axially movable relative to the handle and the first shaft when the lock body is in the unlocked position, and wherein the second shaft is not axially movable relative to the first shaft and the handle when the lock body is in the locked position.

[0190] Example 30. The delivery device of any example herein, particularly Example 29, wherein the lock body comprises a tab engageable by a user, wherein the locking mechanism further comprises at least one detent element positioned to engage the tab when the lock body is in the locked position or the unlocked position.

[0191] Example 31. A delivery apparatus for implanting a prosthetic valve, comprising: a handle comprising a locking mechanism; a first shaft extending from a distal end of the handle; and a second shaft extending through the handle; wherein the locking mechanism comprises a rotatable lock body having internal threads and a collet at least partially received within the lock body, wherein the collet comprises external threads that engage the internal threads of the lock body and is coaxially disposed about the second shaft, wherein rotation of the lock body produces axial movement of the collet relative to the lock body and the second shaft; wherein the lock body is rotatable between a locked position and an unlocked position, wherein when the lock body is in the unlocked position, the second shaft is axially movable relative to the handle, the first shaft, and the collet, and wherein when the lock body is in the unlocked position, the collet prevents axial movement of the second shaft relative to the first shaft and the handle.

[0192] Example 32. The delivery apparatus of any example herein, particularly Example 31, wherein the lock body comprises a cylindrical portion and a tab extending radially outward from the cylindrical portion, wherein the second shaft extends through the cylindrical portion, wherein the locking mechanism further comprises at least one detent element that engages the tab when the lock body is in the locked position or the unlocked position.

[0193] Example 33. The delivery apparatus of any example herein, particularly Example 32, wherein the at least one detent element comprises a first detent element proximal to the locked position and a second detent element proximal to the unlocked position, wherein rotating the tab past the first detent element in a first angular direction aligns the tab with the locked position, and rotating the tab past the second detent element in a second angular direction aligns the tab with the unlocked position, the second angular direction being opposite the first angular direction.

[0194] Example 34. The delivery apparatus of any example herein, particularly any of Examples 32-33, further comprising at least one biasing member configured to bias the at least one detent element in a direction toward the tab.

[0195] Example 35. The delivery apparatus of any example herein, particularly any of Examples 32-34, wherein an inner surface of the cylindrical portion defines a lock cavity having a proximal portion and a distal portion, wherein the lock cavity has a tapered shape such that the proximal portion has a smaller diameter than the distal portion.

[0196] Example 36. The delivery apparatus of any example herein, particularly Example 35, wherein the collet comprises an end plate, a neck extending proximally from the end plate, and a plurality of arms extending proximally from the neck, wherein the second shaft extends through an opening in the end plate and a cavity of the neck, and the plurality of arms are disposed about the second shaft.

[0197] Example 37. The delivery device of any example herein, particularly example 36, wherein the arm and the neck are configured to be inserted into the lock body cavity, wherein the neck is configured to threadably engage internal threads of the lock body such that rotation of the lock body toward the locked position causes the collet to move in a proximal direction and rotation of the lock body toward the unlocked position causes the collet to move in a distal direction.

[0198] Example 38. The delivery device of any example herein, particularly any of examples 36-37, wherein the locking mechanism is configured such that when the lock body is in the locked position, the distal end portion of the arm is inserted into the proximal end portion of the lock body cavity and is compressed radially inward by the proximal end portion of the lock body cavity, and when the lock body is in the unlocked position, the distal end portion of the arm moves into the distal end portion of the lock body cavity and expands radially outward.

[0199] Example 39. The delivery device of any example herein, particularly any of examples 36-38, wherein the second shaft includes a flared portion having a diameter that is greater than a diameter of the opening on the end plate of the collet such that proximal movement of the second shaft is prevented when the flared portion abuts the end plate of the collet.

[0200] Example 40. The delivery device of any example herein, particularly any of examples 31-39, further comprising a gripper located proximally of the proximal end of the handle, wherein the proximal end of the second shaft is connected to the gripper such that axial movement of the gripper causes corresponding axial movement of the second shaft relative to the first shaft when the lock body is in the locked position.

[0201] Example 41. A delivery device for implanting a prosthetic valve, comprising: a handle comprising a locking mechanism, the locking mechanism comprising a lock body having a user-engageable portion; a first shaft extending from a distal end of the handle; a second shaft extending through the handle; wherein the lock body is movable between a locked position and an unlocked position, wherein the second shaft is axially movable relative to the handle and the first shaft when the lock body is in the unlocked position, and wherein the second shaft is not axially movable relative to the first shaft and the handle when the lock body is in the unlocked position; and at least one detent element positioned to engage the user-engageable portion when the lock body is in the locked position or the unlocked position.

[0202] Example 42. The delivery device of any example herein, particularly example 41, wherein the at least one detent element comprises a first detent element proximal to the locked position and a second detent element proximal to the unlocked position, wherein rotating the tab past the first detent element in a first angular direction aligns the tab with the locked position and rotating the tab past the second detent element in a second angular direction aligns the tab with the unlocked position, the second angular direction being opposite the first angular direction.

[0203] Example 43. The delivery device of any example herein, particularly example 41, further comprising at least one biasing member configured to bias the at least one detent element in a direction toward the user-engageable portion.

[0204] Example 44. The delivery device of any example herein, particularly example 42, further comprising first and second biasing members configured to bias the first and second detent elements in a direction toward the user-engageable portion.

[0205] Example 45. The delivery device of any example herein, particularly any of examples 41-44, wherein the locking mechanism further comprises a collet at least partially received within the lock body, wherein the collet comprises external threads that engage internal threads of the lock body and is coaxially disposed about the second shaft, wherein rotation of the lock body produces axial movement of the collet relative to the lock body and the second shaft.

[0206] Example 46. The delivery device of any example herein, particularly example 45, wherein an inner surface of the lock body defines a lock cavity, the lock cavity having a proximal portion and a distal portion, wherein the lock cavity has a tapered shape such that the proximal portion has a smaller diameter than the distal portion.

[0207] Example 47. The delivery device of any example herein, particularly example 46, wherein the collet comprises an end plate, a neck extending proximally from the end plate, and a plurality of arms extending proximally from the neck, wherein the second shaft extends through an opening in the end plate and a lumen of the neck, and the plurality of arms are disposed about the second shaft.

[0208] Example 48. The delivery device of any example herein, particularly example 47, wherein the arms and the neck are configured to be inserted into the lock cavity, wherein the neck is configured to threadably engage the internal threads of the lock body such that rotation of the lock body toward the locked position causes the collet to move in a proximal direction and rotation of the lock body toward the unlocked position causes the collet to move in a distal direction.

[0209] Example 49. The delivery device of any example herein, particularly any of examples 47-48, wherein the locking mechanism is configured such that when the lock body is in the locked position, distal portions of the arms are inserted into the proximal portion of the lock cavity and are compressed radially inward by the proximal portion of the lock cavity, and when the lock body is in the unlocked position, the distal portions of the arms move into the distal portion of the lock cavity and expand radially outward.

[0210] Example 50. The delivery device of any example herein, particularly any of examples 47-49, wherein the second shaft includes a flared portion having a diameter that is greater than a diameter of the opening on the end plate of the collet such that proximal movement of the second shaft is prevented when the flared portion abuts the end plate of the collet.

[0211] Example 51. A delivery device for implanting a prosthetic valve, comprising: a handle including a chamber and a detent disposed inside the chamber; a first shaft extending from a distal end of the handle; a collet located proximal to a proximal end of the handle; and a second shaft extending through an opening on the handle and the detent; wherein a proximal end of the second shaft is connected to the collet; wherein the collet is configured to be axially movable relative to the handle such that axial movement of the collet causes corresponding axial movement of the second shaft relative to the first shaft and the handle; wherein the second shaft includes a flared portion having a diameter that is greater than a diameter of the opening on the detent such that proximal movement of the second shaft is prevented when the flared portion abuts the detent.

[0212] Example 52. The delivery device of any example herein, particularly example 51, wherein the handle further comprises a locking mechanism, wherein the locking mechanism includes a rotatable lock body that is rotatable between a locked position and an unlocked position, wherein the second shaft and the collet are axially movable relative to the handle and the first shaft when the lock body is in the unlocked position, and wherein the second shaft and the collet are not axially movable relative to the handle and the first shaft when the lock body is in the locked position.

[0213] Example 53. The delivery device of any example herein, particularly example 52, wherein an inner surface of the lock body defines a lock cavity having a proximal portion and a distal portion, wherein the lock cavity has a tapered shape such that the proximal portion has a smaller diameter than the distal portion.

[0214] Example 54. The delivery device of any example herein, particularly example 53, wherein the locking mechanism includes a collet at least partially received within the lock cavity, wherein a distal portion of the collet includes the detent, wherein the collet includes external threads that engage internal threads of the lock body and is coaxially disposed around the second shaft, wherein rotation of the lock body causes axial movement of the collet relative to the lock body and the second shaft.

[0215] Example 55. The delivery device of any example herein, particularly example 54, wherein the collet includes a neck portion extending proximally from the detent and a plurality of arms extending proximally from the neck portion, wherein the second shaft extends through a lumen of the neck portion and the plurality of arms are disposed around the second shaft.

[0216] Example 56. The delivery device of any example herein, particularly Example 55, wherein the neck is configured to threadably engage internal threads of the lock body such that rotating the lock body toward the locked position causes the collet to move in a proximal direction and rotating the lock body toward the unlocked position causes the collet to move in a distal direction.

[0217] Example 57. The delivery device of any example herein, particularly any of Examples 55-56, wherein the locking mechanism is configured such that when the lock body is in the locked position, the distal end portions of the arms are inserted into the proximal portion of the lock cavity and compressed radially inward by the proximal portion of the lock cavity, and when the lock body is in the unlocked position, the distal end portions of the arms move into the distal portion of the lock cavity and expand radially outward.

[0218] Example 58. The delivery device of any example herein, particularly any of Examples 52-57, wherein the lock body comprises a user-engageable portion, and the locking mechanism further comprises at least one detent element positioned to engage the user-engageable portion when the lock body is in the locked position or the unlocked position.

[0219] Example 59. The delivery device of any example herein, particularly Example 58, wherein the at least one detent element comprises a first detent element proximal to the locked position and a second detent element proximal to the unlocked position, wherein rotating the tab past the first detent element in a first angular direction aligns the tab with the locked position, and rotating the tab past the second detent element in a second angular direction aligns the tab with the unlocked position, the second angular direction being opposite the first angular direction.

[0220] Example 60. The delivery device of any example herein, particularly Example 59, further comprising first and second biasing members coupled to the first and second detent elements, respectively, and configured to bias the first and second detent elements in a direction toward the user-engageable portion.

[0221] Example 61. A method of implanting a prosthetic valve, the method comprising: inserting a delivery device into a vasculature of a patient, wherein the delivery device comprises a handle, a first shaft extending from a distal end of the handle, and a second shaft extending through a lumen of the first shaft and the handle; wherein a prosthetic valve is crimped over an unexpanded balloon coupled to a distal end portion of the second shaft, and the prosthetic valve is covered by a valve sheath connected to a distal end portion of the first shaft; wherein a proximal end of the second shaft is connected to a collet located proximal to a proximal end of the handle; wherein a distance from an axial axis of the second shaft to a bottom surface of the collet is substantially the same as a distance from an axial axis of the first shaft to a bottom surface of the handle.

[0222] Example 62. The method of any example herein, particularly example 61, wherein the bottom surface of the gripper and the bottom surface of the handle are substantially coplanar.

[0223] Example 63. The method of any example herein, particularly any of examples 61-62, wherein the delivery apparatus further comprises a third shaft extending through the lumen of the second shaft, wherein a proximal end of the third shaft is connected to the gripper and a distal end of the third shaft is connected to the nosecone.

[0224] Example 64. The method of any example herein, particularly example 63, wherein a proximal end of the nosecone abuts a distal end of the valve sheath when the prosthetic valve is covered by the valve sheath.

[0225] Example 65. The method of any example herein, particularly any of examples 63-64, wherein the balloon comprises a proximal portion mounted on a proximal shoulder connected to a distal portion of the second shaft, a distal portion mounted on a distal shoulder connected to a distal portion of the third shaft, and a valve holding portion located between the proximal portion and the distal portion of the balloon, wherein the prosthetic valve is configured to be crimped over the valve holding portion.

[0226] Example 66. The method of any example herein, particularly any of examples 61-65, wherein the delivery apparatus further comprises a guide mounted on the first shaft, the guide comprising a hub and a sheath extending distally from the hub, wherein the first shaft is axially movable relative to the guide.

[0227] Example 67. The method of any example herein, particularly example 66, wherein inserting the delivery apparatus into the vasculature comprises inserting the nosecone, the valve sheath, and the guide together as a single unit until the sheath of the guide is fully inserted into the vasculature, wherein during the act of inserting, a proximal end of the valve sheath abuts a distal end of the sheath of the guide.

[0228] Example 68. The method of any example herein, particularly any of examples 61-67, further comprising navigating the delivery apparatus within the vasculature until the prosthetic valve covered by the valve sheath is positioned at a target location at or near the native valve.

[0229] Example 69. The method of any example herein, particularly example 68, wherein the native valve is a pulmonary valve.

[0230] Example 70. The method of any example herein, particularly example 69, further comprising implanting a docking device at the target location prior to implanting the prosthetic valve, wherein the docking device is configured to receive the prosthetic valve.

[0231] Example 71. The method of any example herein, particularly example 70, wherein the docking device comprises a self-expanding frame configured to securely engage an annulus of the native valve.

[0232] Example 72. The method of any example herein, particularly of any of examples 70-71, further comprising verifying the prosthetic valve is positioned at the target location by aligning radio-opaque markers on the delivery apparatus under fluoroscopy with predefined geometric markers of the docking device, wherein the radio-opaque markers are positioned below the balloon.

[0233] Example 73. The method of any example herein, particularly of any of examples 69-72, wherein the handle comprises a locking mechanism comprising a lock body movable between a locked position and an unlocked position, wherein the second shaft and the gripper are axially movable relative to the handle and the first shaft when the lock body is in the unlocked position, and wherein the second shaft and the gripper are not axially movable relative to the first shaft and the handle when the lock body is in the locked position.

[0234] Example 74. The method of any example herein, particularly of example 73, further comprising moving the lock body to the locked position prior to inserting the delivery apparatus into the vasculature.

[0235] Example 75. The method of any example herein, particularly of any of examples 73-74, further comprising moving the lock body to the unlocked position after positioning the prosthetic valve at the target location.

[0236] Example 76. The method of any example herein, particularly of example 75, further comprising sheathing the prosthetic valve by holding the gripper stationary while moving the handle proximally toward the gripper such that the valve sheath and the first shaft move proximally relative to the second shaft and the prosthetic valve, thereby exposing at least a portion of the prosthetic valve.

[0237] Example 77. The method of any example herein, particularly of example 76, wherein sheathing the prosthetic valve comprises moving the handle proximally until a proximal end of the handle contacts the gripper such that the prosthetic valve is completely uncovered by the valve sheath.

[0238] Example 78. The method of any example herein, particularly of any of examples 76-77, further comprising inflating the balloon to radially expand the prosthetic valve.

[0239] Example 79. The method of any example herein, particularly of example 78, further comprising resheathing the balloon after the balloon is deflated by holding the handle stationary while moving the gripper axially such that the second shaft and the balloon move proximally relative to the valve sheath and the first shaft, thereby covering at least a portion of the balloon with the valve sheath.

[0240] Example 80. The method of any example herein, particularly example 79, wherein sheathing the balloon comprises moving the gripper proximally relative to the handle until the proximal end of the nosecone contacts the distal end of the valve sheath, such that the balloon is fully covered by the valve sheath.

[0241] Example 81. The method of any example herein, particularly any of examples 66-80, further comprising retracting the delivery apparatus by moving the first shaft and the valve sheath proximally until the proximal end of the valve sheath contacts the distal end of the sheath of the introducer, and then retracting the introducer, the first shaft, and the valve sheath together as a single unit out of the vasculature.

[0242] Example 82. The method of any example herein, particularly any of examples 61-81, wherein the delivery apparatus further comprises a fourth shaft extending through the handle, wherein the proximal end of the fourth shaft is connected to the gripper, wherein the fourth shaft comprises a flared portion having a diameter greater than a diameter of an opening of a detent disposed inside the handle, such that when the flared portion abuts the detent, proximal movement of the gripper is prevented.

[0243] Example 83. An assembly comprising: a radially expandable and compressible prosthetic valve; and a delivery apparatus comprising a handle, a gripper located proximal to a proximal end of the handle, a first shaft extending from a distal end of the handle, and a second shaft extending through a lumen of the first shaft and the handle, a proximal end of the second shaft connected to the gripper; wherein the prosthetic valve is mounted on an inflatable balloon coupled to a distal portion of the second shaft; wherein the handle comprises a locking mechanism comprising a lock body having a user-engageable portion, wherein the lock body is movable between a locked position and an unlocked position, wherein the gripper is axially movable relative to the handle when the lock body is in the unlocked position, and wherein the gripper is not axially movable relative to the handle when the lock body is in the locked position; wherein the user-engageable portion is configured to engage at least one detent element when the lock body is in the locked position or the unlocked position.

[0244] Example 84. The assembly of any example herein, particularly example 83, further comprising a valve sheath connected to a distal portion of the first shaft, wherein the valve sheath is configured to cover the prosthetic valve in a radially compressed configuration.

[0245] Example 85. The assembly of any example herein, particularly example 84, further comprising a third shaft extending through the lumen of the second shaft, wherein a proximal end of the third shaft is connected to the gripper and a distal end of the third shaft is connected to a nosecone.

[0246] Example 86. The assembly of any example herein, particularly example 85, wherein a proximal end of the nosecone abuts a distal end of the valve sheath when the prosthetic valve is covered by the valve sheath.

[0247] Example 87. The assembly of any example herein, particularly any of examples 84-86, further comprising a guide mounted on the first shaft, the guide comprising a sheath and a hub connected to a proximal end of the sheath, wherein the first shaft extends through the sheath and the hub and is axially movable relative to the sheath and the hub.

[0248] Example 88. The assembly of any example herein, particularly any of examples 83-87, further comprising a fourth shaft extending through the handle, wherein a proximal end of the fourth shaft is connected to the clamp and the second shaft extends through the fourth shaft.

[0249] Example 89. The delivery device of any example herein, particularly example 88, wherein the fourth shaft comprises a flared portion having a diameter greater than a diameter of an opening of a detent disposed inside the handle, such that proximal movement of the clamp is prevented when the flared portion abuts the detent.

[0250] Example 90. The delivery device of any example herein, particularly any of examples 88-89, wherein the fourth shaft is more rigid than the second shaft.

[0251] Example 91. The delivery device of any example herein, particularly any of examples 88-90, wherein the clamp further comprises a Y-connector having a first port, a second port, and a third port, wherein the second shaft, the third shaft, and the fourth shaft are connected to the first port.

[0252] Example 92. The delivery device of any example herein, particularly example 91, wherein the first port is at a distal portion of the clamp, the second port extends out of a proximal opening of the clamp, and the third port extends out of an upper opening of the clamp.

[0253] In view of the principles disclosed, it will be recognized that the illustrated embodiments are merely representative of the disclosed technology and should not be considered a limitation on the scope of the disclosed technology. Rather, the scope of the disclosed technology is defined by the following claims.

Claims

1. A delivery apparatus for implanting a prosthetic valve, comprising: a handle; a first shaft extending from a distal end of the handle; a second shaft extending through a lumen of the first shaft and the handle; a gripper proximal to a proximal end of the handle; and a third shaft extending through a lumen of the second shaft, wherein a proximal end of the third shaft is connected to the gripper and a distal end of the third shaft is connected to a nosecone; wherein a proximal end of the second shaft is connected to the gripper, and the gripper is axially movable relative to the handle, such that axial movement of the gripper causes corresponding axial movement of the second shaft relative to the first shaft; wherein the gripper has a bottom surface that is coplanar with a bottom surface of the handle.

2. The delivery apparatus of claim 1, wherein a distance from a longitudinal axis of the second shaft to the bottom surface of the gripper is the same as a distance from a longitudinal axis of the first shaft to the bottom surface of the handle.

3. The delivery apparatus of any one of claims 1-2, wherein the first shaft comprises a proximal section, a distal section, and an intermediate section between the proximal section and the distal section, wherein the distal section is more flexible than the intermediate section, and the intermediate section is more flexible than the proximal section.

4. The delivery apparatus of any one of claims 1-2, further comprising an inflatable balloon having a valve holding portion configured to mount the prosthetic valve thereon.

5. The delivery apparatus of claim 4, further comprising a valve sheath configured to cover the prosthetic valve when the prosthetic valve is mounted on the balloon in a radially compressed state, wherein a proximal end of the valve sheath is connected to a distal end of the first shaft, wherein an outer diameter of the valve sheath is greater than an outer diameter of the first shaft.

6. The delivery apparatus of claim 5, wherein a distance between a proximal end of the handle and the gripper is equal to or greater than a length of the valve sheath when the prosthetic valve is covered by the valve sheath, such that when the proximal end of the handle contacts the gripper after axially moving the handle relative to the gripper, a distal end of the valve sheath is located proximal to a proximal end of the prosthetic valve, thereby causing the prosthetic valve to be completely uncovered.

7. The delivery apparatus of claim 1, further comprising a balloon shoulder assembly, wherein the balloon shoulder assembly comprises a proximal shoulder connected to a distal portion of the second shaft and a distal shoulder connected to a distal portion of the third shaft, wherein the distal shoulder and the proximal shoulder are disposed inside the balloon.

8. The delivery apparatus of claim 7, wherein the third shaft comprises a radiopaque marker between the proximal shoulder and the distal shoulder.

9. The delivery apparatus of claim 5, wherein a proximal end of the nosecone abuts a distal end of the valve sheath when the prosthetic valve is held inside the valve sheath. ​ 10. The delivery apparatus of any of claims 1-2, wherein the clamp comprises a housing defining a bottom surface of the clamp, the clamp further comprising a Y-connector having a main tube portion and a side tube portion, the side tube portion fluidly connected to and extending angularly from the main tube portion, wherein the main tube portion extends through the clamp housing and parallel to the bottom surface of the clamp housing, and the side tube portion extends through an opening in a top surface of the clamp housing.

11. The delivery apparatus of claim 10, wherein a proximal end of the second shaft is connected to the main tube portion of the Y-connector.

12. The delivery apparatus of any of claims 1-2, further comprising an introducer mounted on the first shaft, the introducer comprising a sheath and a hub connected to a proximal end of the sheath, wherein the first shaft extends through and is axially movable relative to the sheath and the hub.

13. The delivery apparatus of any of claims 1-2, wherein the handle comprises a locking mechanism comprising a lock body movable between a locked position and an unlocked position, wherein the second shaft is axially movable relative to the handle and the first shaft when the lock body is in the unlocked position, wherein the second shaft is not axially movable relative to the first shaft and the handle when the lock body is in the locked position.

14. The delivery apparatus of claim 13, further comprising a fourth shaft extending through the handle, wherein a proximal end of the fourth shaft is connected to the clamp and the second shaft extends through the fourth shaft.

15. The delivery apparatus of claim 14, wherein the lock body comprises a tab engageable by a user, wherein the locking mechanism further comprises at least one detent element positioned to engage the tab when the lock body is in the locked position or the unlocked position.

16. The delivery apparatus of claim 15, wherein the at least one detent element comprises a first detent element proximal to the locked position and a second detent element proximal to the unlocked position, wherein rotating the tab past the first detent element in a first angular direction causes the tab to align with the locked position, and rotating the tab past the second detent element in a second angular direction causes the tab to align with the unlocked position, the second angular direction being opposite the first angular direction.

17. The delivery apparatus of any of claims 14-16, wherein the locking mechanism further comprises a collet at least partially received within the lock body, wherein the collet comprises external threads that engage internal threads of the lock body and is coaxially disposed about the fourth shaft, wherein rotation of the lock body produces axial movement of the collet relative to the lock body and the fourth shaft.

18. The delivery apparatus of claim 17, wherein the collet has a distal opening through which the fourth shaft extends, the fourth shaft including a flared portion, wherein a diameter of the flared portion is greater than a diameter of the distal opening such that proximal movement of the fourth shaft is prevented when the flared portion abuts the collet.

19. The delivery apparatus of any of claims 14-16, wherein an inner surface of the lock body defines a lock cavity, the lock cavity having a proximal portion and a distal portion, wherein the lock cavity has a tapered shape such that the proximal portion has a smaller diameter than the distal portion.

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