Steerable rail delivery system

Abstract

This application relates to a maneuverable track delivery system. Apparatus, systems, and methods are described herein to provide improved maneuverability for delivering prostheses to body locations, such as delivering a replaced mitral valve to a natural mitral valve location. The maneuverable delivery system may include a maneuverable track configured for multi-planar bending to guide the distal end of the delivery system.

Description

[0001] This application is a divisional application, based on divisional application number 2022104069617. The original application was filed on July 5, 2018, with application number 201880051428.5, and the invention title was "Maneuverable Track Delivery System". Technical Field

[0002] Some embodiments disclosed herein generally relate to prostheses for implantation in a cavity or body cavity and to prosthese delivery systems. Specifically, in some embodiments, the prosthesis and delivery system relate to the replacement of a heart valve, such as the mitral valve. Background Technology

[0003] The valves of the human heart, including the aortic valve, pulmonary valve, mitral valve, and tricuspid valve, essentially act as one-way valves that operate in sync with the pumping heart. These valves allow blood to flow downstream but prevent it from flowing upstream. Diseased heart valves exhibit damage, such as narrowing or regurgitation, which inhibits the valve's ability to control blood flow. This damage reduces the heart's pumping efficiency and can be debilitating and life-threatening. For example, valvular insufficiency can lead to conditions such as cardiac hypertrophy and ventricular dilation. Therefore, extensive efforts have been made to develop methods and devices to repair or replace damaged heart valves.

[0004] Prostheses exist to correct problems associated with damaged heart valves. For example, mechanical and tissue-based heart valve prostheses can be used to replace damaged natural heart valves. Recently, significant efforts have been devoted to developing replacement heart valves, particularly tissue-based replacement heart valves, which are less invasive to patients than open-heart surgery. Replacement valves are being designed for delivery via minimally invasive procedures or even percutaneous procedures. Such replacement valves typically consist of a tissue-based valve body connected to an expandable frame, which is then delivered to the annulus of the natural valve.

[0005] The development of prostheses (including, but not limited to, heart valve replacements, which can be compacted for delivery and then controllably expanded for controlled placement) has proven particularly challenging. Another challenge involves the ability to fix such prostheses in a non-invasive manner relative to intracavitary tissues (e.g., any body cavity or intracavitary tissue).

[0006] Delivering prostheses to the desired location within the body, such as delivering a replacement heart valve to the mitral valve, can also be challenging. Obtaining access to perform procedures in the heart or other anatomical locations may require percutaneous delivery through tortuous vascular systems or via open or semi-open surgical procedures. The ability to control the deployment of the prosthesis at the desired location is also challenging. Summary of the Invention

[0007] Embodiments of this disclosure relate to prostheses, such as, but not limited to, replacement heart valves. Further embodiments relate to delivery systems, devices, and / or methods for delivering and / or controllably deploying prostheses, such as, but not limited to, replacement heart valves, to desired locations within the body. In some embodiments, replacement heart valves and methods for delivering replacement heart valves to natural heart valves, such as the mitral valve, are provided.

[0008] In some embodiments, a delivery system and method are provided for delivering a replacement heart valve to a natural mitral valve location. The delivery system and method may utilize a transseptal approach. In some embodiments, components of the delivery system facilitate bending of the delivery system to steer the prosthesis from the septum to a location within the natural mitral valve. In some embodiments, a capsule is provided for receiving the prosthesis delivered to the natural mitral valve location. In other embodiments, the delivery system and method may be adapted to deliver the implant to a location other than the natural mitral valve.

[0009] This disclosure includes, but is not limited to, the following implementation methods.

[0010] Implementation 1: A delivery system for delivering an expandable implant to a body location, the delivery system including an outer sheath assembly (sheath) The outer sheath assembly includes an outer shaft having an outer cavity and proximal and distal ends, wherein the outer sheath assembly includes an implant retention area configured to retain an expandable implant in a compression configuration; a track assembly located within the outer cavity, the track assembly including a track shaft having a track cavity and proximal and distal ends, wherein the track assembly includes one or more traction wires attached to an inner surface of the track shaft, the traction wires being configured to provide axial force on the track shaft to manipulate the track assembly; and an inner assembly located within the outer cavity, the inner assembly including an inner shaft having an inner cavity and proximal and distal ends, wherein the inner assembly includes an inner retention member configured to releasably attach to the expandable implant, wherein the outer sheath assembly and the inner assembly are configured to move distally together relative to the track assembly while the expandable implant remains in a compression configuration, and wherein the outer sheath assembly is configured to retract proximally relative to the inner assembly to at least partially expand the expandable implant from the compression configuration.

[0011] Implementation 2: The delivery system of Implementation 1, wherein the internal components are located inside the orbital cavity.

[0012] Implementation 3: The delivery system of Implementation 1 or 2 further includes a central axis assembly within an outer cavity, the central axis assembly including a central axis having an intermediate cavity and a proximal and distal end, wherein the central axis assembly includes an outer retaining member configured to radially constrain at least a portion of the expandable implant, and wherein the central axis assembly is configured to move distally relative to the track assembly while the expandable implant remains in a compressed configuration, and wherein the central axis assembly is configured to retract proximally relative to the inner assembly to fully release the expandable implant.

[0013] Implementation 4: The delivery system of Implementation 3, wherein the track assembly is located in the intermediate cavity.

[0014] Implementation 5: The delivery system of any of the foregoing embodiments further includes a nose cone assembly located within the lumen, the nose cone assembly including a nose cone shaft having a guidewire lumen, a proximal end and a distal end, and a nose cone on the distal end, wherein the nose cone assembly is configured to move distally relative to the track assembly while the expandable implant remains in a compressed configuration.

[0015] Implementation 6: The delivery system of Implementation 5, wherein the nasal cone assembly is configured to move distally relative to the track assembly, together with the outer sheath assembly and the inner assembly, while the expandable implant remains in a compressed configuration.

[0016] Implementation 7: The delivery system of Implementation 1, wherein the track assembly is located inside the cavity.

[0017] Implementation 8: A delivery system of any of the foregoing embodiments, wherein the track axis is configured to form a proximal bend and a distal bend.

[0018] Implementation 9: A delivery system in any of the foregoing embodiments, wherein one or more pull wires include a proximal pull wire and a distal pull wire, wherein the proximal pull wire is attached to the track shaft at a position near the attachment point of the distal pull wire.

[0019] Implementation 10: The delivery system of any of the foregoing embodiments further includes a handle, wherein the handle includes a first actuator configured to move the outer sheath assembly and the inner assembly together distally.

[0020] Implementation 11: The delivery system of Implementation 10, wherein the handle includes a second actuator configured to retract the outer sheath assembly proximally relative to the inner assembly.

[0021] Implementation 12: The delivery system of Implementation 3 or 4 further includes a handle, wherein the handle includes a first actuator configured to move the outer sheath assembly, the inner assembly and the central shaft assembly together distally, a second actuator configured to retract the outer assembly proximally relative to the inner assembly, and a third actuator configured to retract the central shaft assembly proximally relative to the inner assembly.

[0022] Embodiment 13: The delivery system of Embodiment 5 or 6 further includes a handle, wherein the handle includes a locking button for preventing axial movement of the nose cone assembly.

[0023] Embodiment 14: The delivery system of Embodiment 3 or 4 further includes a handle, wherein the handle includes a single flushing port, and wherein the single flushing port is configured to provide a fluid inlet between the track cavity, the outer sheath cavity, and the central shaft cavity.

[0024] Implementation 15: The delivery system of any of the foregoing embodiments further includes an expandable implant, wherein the distal end of the expandable implant is constrained by an outer sheath assembly, and the proximal end of the expandable implant is constrained by an inner retaining member of an inner assembly.

[0025] Implementation 16: Delivery system of Implementation 15, wherein the expandable implant includes a replacement mitral valve, the replacement mitral valve including a plurality of anchors configured to be positioned on the ventricular side of the natural mitral valve annulus.

[0026] Implementation 17: A delivery system of any of the foregoing embodiments, wherein the orbital assembly is configured to maneuver the orbital assembly toward the position of the natural mitral valve along an intermittent path.

[0027] Implementation 18: A delivery system of any of the foregoing embodiments, wherein the track includes at least one traction wire cavity attached to the inner surface of the track cavity, wherein at least one traction wire passes through at least one traction wire cavity.

[0028] Implementation 19: The delivery system of Implementation 5 or 6 further includes a guidewire shield with a proximal diameter smaller than the distal diameter, the guidewire shield being located on the nasal cone axis, wherein the guidewire shield is configured to protect the nasal cone axis from being crushed during implant crimping, and wherein the distal end of the expandable implant is configured to radially contact the proximal diameter in a compression configuration.

[0029] Implementation 20: The delivery system of Implementation 1 further includes a central axis assembly within an external cavity, the central axis assembly including a central axis having an intermediate cavity and a proximal and distal end, wherein the central axis assembly includes an external retaining member configured to radially constrain at least a portion of the expandable implant; and a nasal cone assembly located within an internal cavity, the nasal cone assembly including a nasal cone shaft having a guidewire lumen, a proximal end, and a distal end, and a nasal cone at the distal end, wherein the central axis assembly and the nasal cone assembly are configured to move distally relative to the track assembly, together with the outer sheath assembly and the inner assembly, while the expandable implant remains in a compressed configuration, and wherein the central axis assembly is configured to retract proximally relative to the inner assembly to at least partially expand the expandable implant from the compressed position.

[0030] Implementation 21: The delivery system of Implementation 3, wherein the central axis assembly is configured to move distally relative to the track assembly, together with the outer sheath assembly and the inner assembly.

[0031] Implementation 22: The delivery system of Implementation 5, wherein the nose cone assembly is configured to move distally relative to the track assembly, together with the outer sheath assembly and the inner assembly.

[0032] Embodiment 23: A delivery system for delivering an expandable implant to a body location, the delivery system including an outer sheath assembly having an outer cavity and a proximal and distal outer shaft, wherein the outer sheath assembly includes an implant holding region configured to hold the expandable implant in a compression configuration, wherein the outer sheath assembly includes a capsule body at the distal end, the capsule body including an outer polymer layer, a metal interlayer located on a radially inner surface of the outer polymer layer, and an inner liner located on a radially inner surface of the interlayer.

[0033] Embodiment 24: The delivery system of Embodiment 23, wherein the liner comprises extruded PTFE.

[0034] Implementation 25: The delivery system of Implementation 23 or 24, wherein the inner liner wraps around the distal end of the capsule body and contacts the radial outer surface of the outer polymer layer.

[0035] Embodiment 26: The delivery system of any one of Embodiments 23-25 ​​further includes a fluorinated elastomer layer configured to bond the liner to the intermediate layer.

[0036] Embodiment 27: The delivery system of any one of Embodiments 23-26 further includes a fluorinated ethylene polymer layer located between the inner layer and the metal layer.

[0037] Implementation 28: A delivery system of any one of Implementations 23-27, wherein the metal intermediate layer is at least partially a metal coil.

[0038] Embodiment 29: A delivery system of any one of Embodiments 23-28, wherein the outer polymer layer comprises ePTFE.

[0039] Embodiment 30: A delivery system of any one of Embodiments 23-29, wherein the liner comprises pre-axially compressed PTFE.

[0040] Implementation 31: A method for delivering an expandable implant to a body position, the method comprising: delivering an expandable implant within an outer sheath assembly of a delivery system toward the body position, the expandable implant having a distal end and a proximal end, wherein the expandable implant is in a radially compressed configuration within the outer assembly and is releasably held in the outer assembly by an inner retaining member; activating a pull wire in a track assembly of the delivery system to manipulate the delivery system, the track assembly including a track shaft having a track cavity and a proximal end and a distal end, wherein activating the pull wire provides at least one bend to the track shaft; moving the outer sheath assembly and the inner retaining member distally together relative to the track assembly to position the expandable implant at the body position while the expandable implant remains in the radially compressed configuration; and retracting the outer sheath assembly proximally relative to the inner retaining member to at least partially expand the expandable implant from the radially compressed configuration.

[0041] Implementation 32: The method of implementation 31 further includes activating a second pull wire in the track assembly to provide to the second bend of the track shaft.

[0042] Implementation method 33: The method of implementation method 31, wherein the inner retaining member is located inside the track cavity.

[0043] Implementation 34: The method of any one of Implementations 31-33 further includes moving the central axis assembly, which includes an outer retaining member configured to radially constrain at least a portion of the expandable implant, together with the outer sheath assembly and the inner retaining ring, distally to position the expandable implant in a body position while the expandable implant remains in a radially compressed configuration.

[0044] Implementation 35: The method of Implementation 34 further includes retracting the central axis assembly proximally relative to the inner retaining member to at least partially expand the expandable implant.

[0045] Implementation method 36: The method of any one of implementation methods 34-35, wherein the track assembly is located within the central axis assembly.

[0046] Implementation 37: The method of any one of Implementations 31-33 further includes moving the nasal cone assembly, including the nasal cone axis and the nasal cone, together with the outer sheath assembly and the inner retaining member distally to position the expandable implant in a body position while the expandable implant remains in a radially compressed configuration.

[0047] Implementation method 38: The method of any one of implementation methods 31-37 further includes activating a second pull wire in the track assembly to form a second bend in the track shaft.

[0048] Implementation method 39: The method of any one of implementation methods 31-38, wherein moving the outer sheath assembly and the inner retaining member includes activating a first actuator on the handle.

[0049] Implementation 40: The method of any of Implementation 39, wherein retracting the outer sheath assembly proximally includes activating a second actuator on the handle.

[0050] Embodiment 41: The method of any one of Embodiments 31-40, wherein the pull wire passes through a pull wire cavity attached to the inner surface of the track cavity.

[0051] Implementation 42: The method of any one of Implementations 31-41, wherein the body position is the natural mitral valve, and wherein an activated traction filament is provided to at least one curved portion of the track axis to manipulate the delivery system toward the natural mitral valve along an intermittent path.

[0052] Embodiment 43: A delivery system for delivering an expandable implant to a body location, the delivery system comprising an outer sheath assembly including an outer shaft having an outer cavity and proximal and distal ends, wherein the outer sheath assembly includes an implant holding region configured to hold the expandable implant in a compression configuration; a track assembly located within the outer cavity, the track assembly including a track shaft having a track cavity and proximal and distal ends, wherein the track assembly includes one or more traction wires attached to an inner surface of the track shaft, the traction wires being configured to provide axial force on the track shaft to manipulate the track assembly; and an inner assembly located within the outer cavity, the inner assembly including an inner shaft having an inner cavity and proximal and distal ends, wherein the inner assembly includes an implant holding region configured to releasably... An inner retaining member attached to an expandable implant; a central axis assembly within an outer cavity, the central axis assembly including a central axis having an intermediate cavity and a proximal and distal end, wherein the central axis assembly includes an outer retaining member configured to radially constrain at least a portion of the expandable implant; and a nasal cone assembly located within an inner cavity, the nasal cone assembly including a nasal cone shaft having a guidewire lumen, a proximal end, and a distal end, and a nasal cone at the distal end, wherein the outer sheath assembly, central axis assembly, inner assembly, and nasal cone assembly are configured to move distally together relative to a track assembly while the expandable implant remains in a compression configuration, and wherein the outer sheath assembly and central axis assembly are configured to retract proximally individually relative to the inner assembly to at least partially expand the expandable implant from the compression configuration.

[0053] Embodiment 44: The delivery system of Embodiment 3, wherein the outer retaining member includes an inner liner that wraps around the distal end of the outer retaining member and contacts the radial outer surface of the member.

[0054] Embodiment 45: A delivery system for delivering an expandable implant to a body position, the delivery system comprising an outer sheath assembly including an outer shaft having an outer cavity and proximal and distal ends, wherein the outer sheath assembly includes an implant holding region configured to hold the expandable implant in a compression configuration; and a track assembly located within the outer cavity, the track assembly including a maneuverable track axis actuable to a shape including one or more bends, wherein the outer sheath assembly is configured to move distally on the track assembly when the maneuverable track axis is actuated to position the expandable implant, simultaneously in a compression configuration, at a body position, wherein the maneuverable track axis has sufficient rigidity to maintain its shape when the outer sheath assembly moves distally on the track assembly, and wherein when the maneuverable track axis is actuated, the outer sheath assembly, at least in the implant holding region, has sufficient flexibility to track over at least one of the one or more bends of the maneuverable track axis.

[0055] Other embodiments of this disclosure include, but are not limited to, delivery systems comprising one or more of the features described above or further described below. For example, in one embodiment, the delivery system may include a capsule having one or more of the features described herein. In another embodiment, the delivery system may include an axis having one or more of the features described herein. In another embodiment, the delivery system may include a guidewire guard having one or more of the features described herein. In another embodiment, the delivery system may include a maneuverable track having one or more of the features described herein. In another embodiment, the delivery system may include a prosthesis having one or more of the features described herein. In another embodiment, the delivery system may include an external retaining member having one or more of the features described herein. Attached Figure Description

[0056] Figure 1 An implementation of the delivery system is shown.

[0057] Figure 2A Displayed loaded with Figure 3A valve prostheses Figure 1 A partial cross-sectional view of the distal end of the delivery system.

[0058] Figure 2B Showing none Figure 3A valve prostheses Figure 1 A partial cross-sectional view of the distal end of the delivery system.

[0059] Figure 2C Showing Figure 1 A partial cross-sectional view of the far end of the delivery system, where some shaft components have not translated along the track components.

[0060] Figure 3AA side view shows an embodiment of a valve prosthesis that can be delivered using the delivery system described herein.

[0061] Figure 3B A side view shows an embodiment of an aortic valve prosthesis that can be delivered using the delivery system described herein.

[0062] Figure 4 Showing Figure 1 A three-dimensional view of the remote end of the delivery system.

[0063] Figure 5 Showing Figure 4 The delivery system components, wherein the outer sheath assembly moves proximally and out of view.

[0064] Figure 6A Showing Figure 5 The delivery system components, in which the central axis assembly moves proximally and out of view.

[0065] Figure 6B The cross-section of the track assembly is shown in the example.

[0066] Figure 7 Showing Figure 6A The components of the delivery system, in which the track assembly moves to the proximal side and leaves the view.

[0067] Figure 8 Showing Figure 7 The components of the delivery system, in which the inner components move proximally and leave the view.

[0068] Figure 9A and 9B An example of an implementation of the guide wire protection device is provided.

[0069] Figure 10 An example of an implementation of a hypotube is provided.

[0070] Figure 11 An example of how to implement a centrally mounted sodium hypochlorite tube is given.

[0071] Figure 12A Examples of flat styles (patterns) Figure 11 The implementation method of the central axis submersible tube.

[0072] Figure 12B An example of an implementation of an external retaining ring is provided.

[0073] Figure 13 An example of how to implement the track component is given.

[0074] Figure 14 An example of how the internal components can be implemented is given.

[0075] Figure 15 An example of the cross-section of the capsule is shown.

[0076] Figure 16 An example of an implementation of a delivery system handle is provided.

[0077] Figure 17 Example Figure 16 The cross-section of the delivery system handle.

[0078] Figure 18 A schematic diagram of an interval delivery path is shown.

[0079] Figure 19 A schematic diagram of a valve prosthesis located within a natural mitral valve is shown.

[0080] Figure 20 The valve prosthesis framework located inside the heart is shown.

[0081] Figure 21-23 The steps of a method for delivering a valve prosthesis to an anatomical location are shown.

[0082] Figure 24A -B illustrates a method for orbital delivery systems.

[0083] Figure 25 The optional implementation of the delivery system is shown.

[0084] Figure 26A Displayed loaded with Figure 3A valve prostheses Figure 25 A partial cross-sectional view of the distal end of the delivery system.

[0085] Figure 26B Showing none Figure 3A valve prostheses Figure 25 A partial cross-sectional view of the distal end of the delivery system.

[0086] Figure 26C Showing a central axis assembly without Figure 3A A partial cross-sectional view of the distal end of the valve prosthesis delivery system.

[0087] Figure 27 Showing Figure 25 A three-dimensional view of the remote end of the delivery system.

[0088] Figure 28 Showing Figure 27 The delivery system components, wherein the outer sheath assembly moves proximally and out of view.

[0089] Figure 29 Showing Figure 28 The components of the delivery system, in which the inner components move proximally and leave the view.

[0090] Figure 30 The implementation method of the offshore waveguide is shown.

[0091] Figure 31 The implementation method of the inland subsea wave tube is shown.

[0092] Figure 32 This illustrates an implementation of an orbital submersible tube.

[0093] Figure 33 An implementation of the delivery system handle is shown.

[0094] Figures 34-36 The steps of a method for delivering a valve prosthesis to an anatomical location are shown.

[0095] Figure 37 A side view shows an embodiment of a valve prosthesis that can be delivered using the delivery system described herein.

[0096] Figure 38A-40 A view showing an embodiment of a valve prosthesis that can be delivered using the delivery system described herein. Detailed Implementation

[0097] This specification and accompanying drawings provide aspects and features of this disclosure within the context of several embodiments of replacement heart valves, delivery systems, and methods configured for use in a patient's vascular system, such as for replacing a natural heart valve in a patient. These embodiments may be discussed in conjunction with the replacement of a specific valve (such as a patient's aortic, tricuspid, or mitral valve). However, it should be understood that the features and concepts discussed herein are applicable to products other than heart valve implants. For example, the controlled positioning, deployment, and fixation features described herein can be applied to medical implants, such as other types of expandable prostheses, for use in other parts of the body, such as within arteries, veins, or other body cavities or locations. Furthermore, specific features of valves, delivery systems, etc., should not be considered limiting, and features of any embodiment discussed herein may be combined with features of other embodiments as needed and where appropriate. Although some embodiments described herein are described in conjunction with a transfemoral artery delivery route, it should be understood that these embodiments may be used with other delivery routes, such as, for example, transapical or transjugular venous routes. Moreover, it should be understood that certain features described in conjunction with some embodiments may be combined with other embodiments, including those described in conjunction with different delivery routes.

[0098] Delivery system Figure 1Examples of implementations of delivery device, system, or component 10 are illustrated. Delivery system 10 can be used to deploy prostheses, such as replacing heart valves, in vivo. In some implementations, delivery system 10 may use a biplane deflection path to properly deliver the prosthesis. The replacement heart valve can be delivered to the patient's mitral valve annulus or other heart valve locations in various ways, such as through open surgery, minimally invasive surgery, and percutaneous or transcatheter delivery via the patient's vascular system. An exemplary transfemoral artery approach can be found in U.S. Patent Publication No. 2015 / 0238315, filed February 20, 2015 (the entire contents of which are incorporated herein by reference). Although delivery system 10 is described in conjunction with a percutaneous delivery path, and more specifically with a transfemoral artery delivery path, it should be understood that the features of delivery system 10 can be applied to other delivery systems, including delivery systems for transapical delivery paths.

[0099] Delivery system 10 can be used to deploy prostheses in vivo, such as heart valve replacements as described elsewhere in this specification. Delivery system 10 can receive and / or cover portions of the prosthesis, as follows: Figure 3A The first end 301 and the second end 303 of the prosthesis 70 shown are illustrated. For example, the delivery system 10 can be used to deliver an expandable implant or prosthesis 70, wherein the prosthesis 70 includes a first end 301 and a second end 303, and wherein the second end 303 is configured to be deployed or expanded prior to the first end 301.

[0100] Figure 2A An example of a prosthesis 70 is further shown, which can be inserted into the delivery system 10, specifically into the implant holding region 16. For ease of understanding, in Figure 2A In the image, only the exposed metal frame shown as an example is presented. The implant or prosthesis 70 can take any number of different forms. Although in Figure 3A A specific example of the prosthesis frame is shown, but it will be understood that other designs may also be used. The prosthesis 70 may include one or more sets of anchors, such as distal (or ventricular) anchors 80 extending proximally when the prosthesis frame is in an expanded configuration and proximal (or atrial) anchors 82 extending distally when the prosthesis frame is in an expanded configuration. The prosthesis may further include a strut 72, which may terminate at a mushroom-shaped tab 74 at a first end 301. Further discussion can be found in U.S. Publication No. 2015 / 0328000A1, published November 19, 2015, the entire contents of which are incorporated herein by reference.

[0101] In some implementations, the delivery system 10 may be compatible with, for example, Figure 3BThe aortic valve replacement shown is used in combination. In some embodiments, the delivery system 10 may be modified to support and deliver the aortic valve replacement. However, the procedures and structures discussed below can be similarly used for mitral valve replacement and aortic valve replacement.

[0102] Further details and exemplary designs of the prosthesis are described in U.S. Patent Nos. 8,403,983, 8,414,644, 8,652,203 and U.S. Patent Publications 2011 / 0313515, 2012 / 0215303, 2014 / 0277390, 2014 / 0277422, 2014 / 0277427, 2018 / 0021129, and 2018 / 0055629, the entire contents of which are incorporated herein by reference and form part of this specification. Further details and embodiments of replacement heart valves or prostheses and methods of implantation thereof are described in U.S. Publications 2015 / 0328000 and 2016 / 0317301, the entire contents of each of which are incorporated herein by reference and form part of this specification.

[0103] The delivery system 10 can be relatively flexible. In some embodiments, the delivery system 10 is particularly adapted to deliver the replacement heart valve to the mitral valve location via a transseptal route (e.g., between the right and left atria, via transseptal puncture).

[0104] like Figure 1 As shown, the delivery system 10 may include a shaft assembly 12, which includes a proximal end 11 and a distal end 13, wherein a handle 14 is coupled to the proximal end of the assembly 12. The shaft assembly 12 can be used to hold the prosthesis to advance it through the vascular system to the treatment location. The delivery system 10 may further include a relatively rigid, live-on (or integrated) sheath 51 surrounding the shaft assembly 12 to prevent undesirable movement of the shaft assembly 12. The live-on sheath 51 may be attached to the proximal end of the shaft assembly 12 near the handle 14 (e.g., at the sheath hub). The shaft assembly 12 may include an implant retention area 16 at its distal end for this purpose (which is shown in the diagram). Figure 2A -B, where Figure 2A The prosthesis was shown as 70, while Figure 2B (The prosthesis 70 is removed). In some embodiments, the shaft assembly 12 may hold the compressed expandable prosthesis in the implant holding region 16 to advance the prosthesis 70 in vivo. The shaft assembly 12 may then be used to allow controlled expansion of the prosthesis 70 at the treatment location. In some embodiments, the shaft assembly 12 may be used to allow orderly, controlled expansion of the prosthesis 70, as discussed in detail below. Figure 2A-B shows the implant holding region 16 at the distal end of the delivery system 10, but it may also be in other locations. In some embodiments, the prosthesis 70 may be rotated within the implant holding region 16, such as by rotation of the inner shaft assembly 18 discussed herein.

[0105] like Figure 2A As shown in the cross-sectional view of -B, the distal end of the delivery system 10 may include one or more sub-assemblies, such as the outer sheath assembly 22, central shaft assembly 21, track assembly 20, inner shaft assembly 18, and nose cone assembly 31, which will be described in more detail below. In some embodiments, the delivery system 10 may not have all the components disclosed herein. For example, in some embodiments, as shown below... Figures 25-36 In the embodiments described, the complete central axis assembly may not be incorporated into the delivery system 10. In some embodiments, the components disclosed below may be in a radial order different from the order discussed.

[0106] Specifically, embodiments of the disclosed delivery system 10 may utilize a manipulable track in the track assembly 20 to manipulate the distal end of the delivery system 10, thereby allowing proper positioning of the implant within the patient's body. As discussed in detail below, the manipulable track may be, for example, a track shaft that extends from the handle 14 through the delivery system 10 generally to the distal end. In some embodiments, the manipulable track has a distal end terminating near the implant holding region 16. The user can manipulate the curvature of the distal end of the track, thereby bending the track in a specific direction. In a preferred embodiment, the track has more than one bend along its length, thus providing multiple bending directions. When the track bends, it presses against other components, causing them to also bend, so that other components of the delivery system 10 can be configured to be manipulated together with the track as a cooperating single unit, thereby providing complete manipulability of the distal end of the delivery system.

[0107] Once the track is maneuvered to a specific location within the patient's body, the prosthesis 70 can be advanced along or relative to the track and released into the body by movement of other sheaths / axles relative to the track. For example, the track can be bent into a desired location within the body to guide the prosthesis 70, such as toward a natural mitral valve. Other components (e.g., outer sheath assembly 22, central axis assembly 21, inner component 18, and nasal cone assembly 31) can passively follow the bending of the track. Additionally, other components (e.g., outer sheath assembly 22, central axis assembly 21, inner component 18, and nasal cone assembly 31) can be advanced together relative to the track (e.g., relatively together, successively with a single actuator, simultaneously, almost simultaneously, momentarily, almost momentarily), while maintaining the prosthesis 70 in a compressed position without releasing or expanding the prosthesis 70 (e.g., within the implant retention area 16). Other components (e.g., outer sheath assembly 22, central axis assembly 21, inner component 18, and nasal cone assembly 31) can be advanced together distally or proximally relative to the track. In some implementations, only the outer sheath assembly 22, the central axis assembly 21, and the inner assembly 18 are advanced together above the track. Therefore, the nasal cone assembly 31 may remain in the same position. The assemblies may be translated individually, sequentially, or simultaneously relative to the inner assembly 18 to release the implant 70 from the implant retention region 16.

[0108] Figure 2C Examples are given of sheath assemblies (particularly outer sheath assembly 22), central shaft assembly 21, inner shaft assembly 18, and nasal cone assembly 31 that have been translated distally together along track assembly 20; further details of the assemblies are provided below. In some embodiments, the outer sheath assembly 22, central shaft assembly 21, inner shaft assembly 18, and nasal cone assembly 31 are translated together (e.g., relatively together, successively with a single actuator, simultaneously, almost simultaneously, momentarily, almost momentarily). This distal translation can occur while the implant 70 remains in a compressed configuration within the implant retention region 16.

[0109] like Figure 2A-2C As shown and further as Figure 4-8As shown, starting with the outermost component, the delivery system may include an outer sheath assembly 22, which forms a radially outer cover or sheath to surround the implant retention region 16 and prevent radial expansion of the implant. Specifically, the outer sheath assembly 22 prevents radial expansion of the distal end of the implant. Moving radially inward, the central axis assembly 21 may consist of a central axis hypotube 43, the distal end of which is attached to an outer retention member or outer retention ring 42 to radially retain a portion of the prosthesis (e.g., the proximal end of the prosthesis 70) in a compact configuration. The central axis assembly 21 may be located within the cavity of the outer sheath assembly 22. Moving further inward, the track assembly 20 may be configured to be maneuverable, as described above and further below. The track assembly 20 may be located within the cavity of the central axis assembly 21. Moving further inward, the inner axis assembly 18 may consist of an inner axis, the distal end of which is attached to an inner retention member or inner retention ring 40 (e.g., a PEEK ring) to axially retain the prosthesis (e.g., the proximal end of the prosthesis). The inner shaft assembly 18 may be located within the cavity of the track assembly 20. Furthermore, the most radially inwardly located assembly is the nose cone assembly 31, which includes a nose cone shaft 27, the distal end of which is connected to a nose cone 28. The nose cone 28 may have a tapered tip. The nose cone assembly 31 is preferably located within the cavity of the inner shaft assembly 18. The nose cone assembly 31 may include a cavity to allow a guidewire to pass through.

[0110] The axial assembly 12, and more specifically the nasal cone assembly 31, inner assembly 18, track assembly 20, central axis assembly 21, and outer sheath assembly 22, can be collectively configured to hold the prosthesis 70 located within the implant holding region 16. Figure 2A (As shown) is delivered to the treatment location. One or more sub-components can then be moved to allow the prosthesis 70 to be released at the treatment location. For example, one or more sub-components can be moved relative to one or more other sub-components. The handle 14 may include various control mechanisms that can be used to control the movement of the various sub-components, which will also be described in more detail below. In this way, the prosthesis 70 can be controllably loaded onto the delivery system 10 and then deployed in the body. In addition, the handle 14 can provide manipulation of the track assembly 20, thereby providing bending / deflection / manipulation to the distal end of the delivery system 10.

[0111] As will be discussed below, the inner retaining member 40, the outer retaining ring 42, and the outer sheath assembly 22 can cooperate to hold the prosthesis 70 in a compact configuration. Figure 2AIn this configuration, the inner retaining member 40 is shown engaging the strut 72 at the proximal end 301 of the prosthesis 70. For example, slots between radially extending teeth on the inner retaining member 40 may receive and engage the strut 72, which may terminate in a mushroom-shaped projection 74 on the proximal end of the prosthesis 70. A central axis assembly 21 may be positioned above the inner retaining member 40 such that the first end 301 of the prosthesis 70 is captured between the inner retaining member 40 and the outer retaining ring 42, thereby securely attaching it to the delivery system 10 between the central axis assembly 21 and the outer retaining ring 42. An outer sheath assembly 22 may be positioned to cover the second end 303 of the prosthesis 70.

[0112] The outer retaining member 42 can be attached to the distal end of the central thiopancreatic tube 43, which can then be attached proximally to the proximal tube 44, which can then be attached proximally to the handle 14. When in the compressed position, the outer retaining member 42 provides further stability to the prosthesis 70. The outer retaining member 42 can be positioned above the inner retaining member 40 such that the proximal end of the prosthesis 70 is captured therebetween, thereby securely attaching it to the delivery system 10. The outer retaining member 42 can surround a portion of the prosthesis 70, specifically the first end 301, to prevent the prosthesis 70 from expanding. Furthermore, the central axial assembly 21 can be translated proximally relative to the inner assembly 18 into the outer sheath assembly 22, thereby exposing the first end 301 of the prosthesis 70 held within the outer retaining member 42. In this way, the outer retaining member 42 can be used to assist in securing the prosthesis 70 to or from the delivery system 10. Although the outer retaining member 42 may have a cylindrical or elongated tubular shape and may be referred to as an outer retaining ring, there are no restrictions on its specific shape.

[0113] The central thorax tube 43 itself may be made of, for example, high-density polyethylene (HDPE) and other suitable materials described herein. The central thorax tube 43 may be formed from longitudinally pre-compressed HDPE tubing, which provides certain benefits. For example, the pre-compressed HDPE tubing can apply a force distally to the outer retainer 42, thereby preventing accidental, unintentional, and / or premature release of the prosthesis 70. Specifically, the distal force of the central thorax tube 43 holds the distal end of the outer retainer 42 distal to the inner retainer 40, thereby preventing the outer retainer 42 from moving proximally to the inner retainer 40 before the user expects to release the prosthesis 70. This can still be true even when the delivery system 10 is bent / deflected at an acute angle. Further disclosure regarding the outer retainer 42 and the central thorax tube 43 can be found in U.S. Patent Publication No. 2016 / 0317301, the entire contents of which are incorporated herein by reference.

[0114] like Figure 2AAs shown, the distal anchor 80 may be located in a delivery configuration where the distal anchor 80 is generally pointing distally (as shown, axially away from the body of the prosthesis frame and away from the handle of the delivery system). The outer sheath assembly 22 may constrain the distal anchor 80 in this delivery configuration. Thus, when the outer sheath 22 is retracted proximally, the distal anchor 80 may flip (filp) its position (e.g., bend approximately 180 degrees) to the deployed configuration (e.g., generally pointing proximally). Figure 2A Also shown is a proximal anchor 82, which extends distally within the outer sheath assembly 22 in its delivery configuration. In other embodiments, the distal anchor 80 may be held to point generally proximal in the delivery configuration and compressed against the body of the prosthetic frame.

[0115] The delivery system 10, pre-installed with the prosthesis 70, can be provided to the user. In other embodiments, the prosthesis 70 may be loaded onto the delivery system shortly before use, such as by a physician or nurse.

[0116] Delivery system components Figure 4-8 Another view of the delivery system 10 is shown, in which the different components are translated proximally and described in detail.

[0117] from Figure 4 Starting with the outermost component shown, the outer sheath assembly 22 may include an outer proximal shaft 102 directly attached to the handle 14 at its proximal end and an outer submersible tube 104 attached to its distal end. A capsule body 106 may then be attached substantially to the distal end of the outer submersible tube 104. In some embodiments, the capsule body 106 may be 28 French inches or smaller. These components of the outer sheath assembly 22 may form cavities to allow other sub-assemblies to pass through.

[0118] The outer proximal shaft 102 can be a tube, and is preferably formed of plastic, but can also be a metal submersible tube or other materials. The outer submersible tube 104 can be a metal submersible tube, and in some embodiments, the metal submersible tube may be cut or have slots, as discussed in detail below. The outer submersible tube 104 may be covered or encapsulated with ePTFE, PTFE or other polymer / material layers, such that the outer surface of the outer submersible tube 104 is generally smooth.

[0119] Capsule body 106 may be located at the distal end of the proximal axis 102. Capsule body 106 may be a tube formed of plastic or metal material. In some embodiments, capsule body 106 is formed of ePTFE or PTFE. In some embodiments, this capsule body 106 is relatively thick to prevent tearing and help maintain the self-expanding implant in a compact configuration. In some embodiments, the material of capsule body 106 is the same as the coating on the outer submersible tube 104. As shown, the diameter of capsule body 106 may be larger than that of outer submersible tube 104, but in some embodiments, the diameter of capsule body 106 may be similar to that of submersible tube 104. In some embodiments, capsule body 106 may include a distal portion with a larger diameter and a proximal portion with a smaller diameter. In some embodiments, a step or taper may be present between these two portions. Capsule body 106 may be configured to hold prosthesis 70 in a compressed position within capsule body 106. Further construction details of capsule body 106 are discussed below.

[0120] The outer sheath assembly 22 is configured to slide independently relative to the other components. In addition, the outer sheath assembly 22 can slide distally and proximally relative to the track assembly 22 together with the central shaft assembly 21, the inner assembly 18 and the nose cone assembly 31.

[0121] Moving radially inward, the next component is the central axis assembly 21. Figure 5 Showing with Figure 4 A similar view, but with the outer sheath component 22 removed, thus exposing the central axis component 21.

[0122] The central axis assembly 21 may include a central axis tube 43 generally attached at its proximal end to a central axis proximal tube 44, which in turn may be attached at its proximal end to a handle 14; and an outer retaining ring 42 located at the distal end of the central axis tube 43. Thus, the outer retaining ring 42 may be generally attached at the distal end of the central axis tube 43. These components of the central axis assembly 21 may form a cavity to allow other sub-assemblies to pass through.

[0123] Similar to other components, the central thiazoline tube 43 and / or the central proximal tube 44 may include a tube, such as a subcutaneous tube or a thiazoline tube (not shown). The tube may be made of any number of different materials, including nitinol, stainless steel, and medical-grade plastics. The tube may be a single piece or multiple pieces joined together. Using a tube made of multiple pieces allows the tube to provide different properties, such as rigidity and flexibility, along different sections of the tube. The central thiazoline tube 43 may be a metal thiazoline tube, which in some embodiments may be cut or have slots, as discussed in detail below. The central thiazoline tube 43 may be covered or encapsulated with a layer of ePTFE, PTFE, or other material, such that the outer surface of the central thiazoline tube 43 is generally smooth.

[0124] The outer retaining ring 42 can be configured as a prosthesis retaining mechanism, which can be used to engage with the prosthesis 70, as per [reference needed]. Figure 2A This is under discussion. For example, the outer retaining ring 42 may be a ring or cover configured to radially cover the strut 72 on the prosthesis 70. The outer retaining ring 42 may also be considered part of the implant retention region 16 and may be located proximally to the implant retention region 16. When the strut or other portion of the prosthesis 70 engages with the inner retaining member 40, as described below, the outer retaining ring 42 may cover both the prosthesis 70 and the inner retaining member 40 to secure the prosthesis 70 to the delivery system 10. Thus, the prosthesis 70 may be clamped between the inner retaining member 40 of the inner shaft assembly 18 and the outer retaining ring 42 of the central shaft assembly 21.

[0125] The central axis assembly 21 is arranged to slide independently relative to the other assemblies. In addition, the central axis assembly 21 can slide distally and proximally relative to the track assembly 22 together with the outer sheath assembly 22, the intermediate inner assembly 18 and the nose cone assembly 31.

[0126] Next, on the radially inner side of the central axis assembly 21 is the track assembly 20. Figure 6A Showing with Figure 5 The view is largely the same, but the central axis component 21 has been removed, thus exposing the track component 20. Figure 6B A cross-section of the track assembly 20 is further shown to observe the traction wire. The track assembly 20 may include a track shaft 132 (or track) generally attached to the handle 14 at its proximal end. The track shaft 132 may consist of a track proximal shaft 134 directly attached to the handle at its proximal end and a track hyaluronic acid tube 136 attached to the distal end of the track proximal shaft 134. The track hyaluronic acid tube 136 may also include a non-invasive track tip at its distal end. Furthermore, as shown in FIG. 6, the distal end of the track hyaluronic acid tube 136 may be adjacent to the proximal end of the inner retaining member 40. In some embodiments, the distal end of the track hyaluronic acid tube 136 may be spaced apart from the inner retaining member 40. These components of the track shaft assembly 20 may form cavities to allow other sub-assemblies to pass through.

[0127] like Figure 6B As shown, one or more pull wires are attached to the inner surface of the track 136, which can be used to apply force to the track 136 and manipulate the track assembly 20. The pull wires may extend distally from a knob in the handle 14 discussed below to the track 136. In some embodiments, the pull wires may be attached at different longitudinal locations on the track 136, thereby providing multiple bending positions within the track 136 to allow for multidimensional manipulation.

[0128] In some embodiments, the distal pull wire 138 may extend to the distal section of the orbital sluice tube 136, while two proximal pull wires 140 may extend to the proximal section of the orbital sluice tube 136. However, other numbers of pull wires may be used, and the specific number of pull wires is not limited. For example, two pull wires may extend to the distal position, while a single pull wire may extend to the proximal position. In some embodiments, annular structures attached to the interior of the orbital sluice tube 136, such as the proximal ring 137 and the distal ring 135, referred to as pull wire connectors, may be used as attachment points for the pull wires. In some embodiments, the orbital assembly 20 may include a distal pull wire connector 135 and a proximal pull wire connector 139. In some embodiments, the pull wires may be directly connected to the inner surface of the orbital sluice tube 136.

[0129] The distal pull wire 138 may be connected approximately at the distal end of the orbital lenticule 136 (alone or via connector 135). The proximal pull wire 140 may be connected at approximately one-quarter, one-third, or one-half of the length of the orbital lenticule 136 from the proximal end (alone or via connector 137). In some embodiments, the distal pull wire 138 may pass through a small-diameter pull wire cavity 139 (e.g., a tube, lenticule tube, cylinder) attached to the interior of the orbital lenticule 136. This prevents the wire 138 from pulling the orbital lenticule 136 near the distal connection. Furthermore, the cavity 139 may act as a compression coil to reinforce the proximal portion of the orbital lenticule 136 and prevent undesirable bending. Therefore, in some embodiments, the cavity 139 is located only on the proximal half of the orbital lenticule 136. In some embodiments, each distal wire 139 may use multiple cavities 139, such as longitudinally spaced or adjacent. In some embodiments, each distal filament 139 uses a single cavity 139. In some embodiments, the cavity 139 may extend into the distal half of the orbital hysteresis tube 136. In some embodiments, the cavity 139 is attached to the outer surface of the orbital hysteresis tube 136. In some embodiments, the cavity 139 is not used.

[0130] For the paired proximal traction wires 140, the wires may be spaced approximately 180° apart to allow manipulation in both directions. Similarly, if a pair of distal traction wires 138 are used, the wires may be spaced approximately 180° apart to allow manipulation in both directions. In some embodiments, the paired distal traction wires 138 and the paired proximal traction wires 140 may be spaced approximately 90° apart. In some embodiments, the paired distal traction wires 138 and the paired proximal traction wires 140 may be spaced approximately 0° apart. However, other positions of the traction wires may also be used, and the specific positions of the traction wires are not limited. In some embodiments, the distal traction wire 138 may pass through a cavity 139 attached within the cavity of the orbital sluice tube 136. This prevents axial forces on the distal traction wire 138 from causing bending in the proximal section of the orbital sluice tube 136.

[0131] The track assembly 20 is arranged to slide over the inner shaft assembly 18 and the nasal cone assembly 31. In some embodiments, the outer sheath assembly 22, the central shaft assembly 21, the inner shaft assembly 22, and the nasal cone assembly 31 may be configured to slide together along or relative to the track assembly 20, such as sliding together proximally and distally with or without any curvature of the track assembly 20. In some embodiments, the outer sheath assembly 22, the central shaft assembly 21, the inner shaft assembly 22, and the nasal cone assembly 31 may be configured to hold the implant 70 in a compressed position when they slide simultaneously along or relative to the track assembly 20.

[0132] Moving radially inward, the next component is the inner shaft assembly 18. Figure 7 Showing with Figure 6A The view is largely the same, but the track component 20 has been removed, thus exposing the inner axis component 18.

[0133] The inner shaft assembly 18 may include an inner shaft 122 generally attached to the handle 14 at its proximal end, and an inner retaining ring 40 located at the distal end of the inner shaft 122. The inner shaft 122 itself may consist of an inner proximal shaft 124 directly attached to the handle 14 at its proximal end and a distal segment 126 attached to the distal end of the inner proximal shaft 124. Thus, the inner retaining ring 40 may be generally attached to the distal end of the distal segment 126. These components of the inner shaft assembly 18 may form a cavity to allow other sub-assemblies to pass through.

[0134] Similar to other components, the inner proximal shaft 124 may include a tube, such as a hypodermic tube or a hypodermic tube (not shown). The tube may be made of any number of different materials, including nitinol, cobalt-chromium alloys, stainless steel, and medical-grade plastics. The tube may be a single piece or multiple pieces joined together. Tubes comprising multiple pieces may provide different properties, such as rigidity and flexibility, along different sections of the tube. The distal section 126 may be a metallic hypodermic tube, which in some embodiments may be cut or have slots, as discussed in detail below. The distal section 126 may be covered or encapsulated with a layer of ePTFE, PTFE, or other material, such that the outer surface of the distal section 126 is generally smooth.

[0135] The inner retaining member 40 can be configured as a prosthesis retaining mechanism for engagement with the prosthesis 70, as per [reference needed]. Figure 2A As discussed, for example, the inner retaining member 40 may be a ring and may include a plurality of slots configured to engage with the strut 72 on the prosthesis 70. The inner retaining member 40 may also be considered as part of the implant retention region 16 and may be located proximally in the implant retention region 16. When the strut or other portion of the prosthesis 70 engages with the inner retaining member 40, the outer retaining ring 42 may cover both the prosthesis and the inner retaining member 40 to secure the prosthesis to the delivery system 10. Thus, the prosthesis 70 may be clamped between the inner retaining member 40 of the inner axis assembly 18 and the outer retaining ring 42 of the central axis assembly 21.

[0136] The inner shaft assembly 18 is arranged to slide independently relative to the other assemblies. In addition, the inner assembly 18 can slide distally and proximally relative to the track assembly 22 together with the outer sheath assembly 22, the central shaft assembly 21, and the nose cone assembly 31.

[0137] Moving further inward from the inner shaft assembly 18 is the nose cone assembly 31, which is also... Figure 8 As shown. This can be a nasal cone shaft 27, and in some embodiments, a nasal cone 28 may be present at its distal end. The nasal cone 28 may be made of polyurethane for non-invasive access and to minimize damage to the venous vascular system. The nasal cone 28 may also be radiopaque to provide visibility under fluorescence examination.

[0138] The nasal cone shaft 27 may include a cavity, which is sized and configured to slidably receive a guidewire, allowing the delivery system 10 to be advanced over the guidewire through the vascular system. However, embodiments of the system 10 discussed herein may be implemented without a guidewire, and therefore the nasal cone shaft 27 may be solid. The nasal cone shaft 27 may be connected from the nasal cone 28 to a handle, or may be formed from different portions such as other components. Furthermore, the nasal cone shaft 27 may be formed from different materials (such as plastic or metal) similar to those described in detail above.

[0139] In some embodiments, the nasal cone shaft 27 includes a guidewire guard 1200 located on a portion of the nasal cone shaft 27. Examples of such a guidewire guard may be found in... Figure 9A -B is found. In some embodiments, the guidewire guard 1200 may be proximal to the nasal cone 28. In some embodiments, the guidewire guard 1200 may be translated along the nasal cone axis 27. In some embodiments, the guidewire guard 1200 may be locked in place along the nasal cone axis 27. In some embodiments, the guidewire guard 1200 may be at least partially located within the nasal cone 28.

[0140] Advantageously, the guidewire guard 1200 allows for smooth guidewire tracking during implantation of the implant 70 and provides a large axial diameter landing zone for the distal end of the implant, allowing the distal end of the implant 70 to unfold appropriately and be positioned in a uniform radial arrangement. This uniformity allows for proper expansion. Furthermore, the guidewire guard 1200 prevents kinking or damage to the nasal conus axis 27 during compression / folding of the implant 70, which applies significant compressive forces to the nasal conus axis 27. Because the implant 70 can fold over the guidewire guard 1200 rather than directly over the nasal conus axis 27, the guidewire guard 1200 provides a protective surface.

[0141] As shown, the guidewire guard 1200 may include a cavity 1202 configured to surround the nasal cone axis 27. The guidewire guard 1200 may include a distal end 1204 with a larger diameter and a proximal end 1206 with a smaller diameter. In some embodiments, the dimensional change between the two ends may be tapered, or may be as follows: Figure 9A The step 1208 is shown. The distal end 1204 may include multiple indents 1210 to make it easier for the user to grip, but may not be included in all embodiments. Both the proximal end 1206 and the distal end 1204 may be generally cylindrical, but there is no limitation on the specific shape of the guidewire guard 1200.

[0142] The distal end of the prosthesis 70 may be folded so that it radially contacts the proximal end 1206 of the guidewire guard 1200. This allows the prosthesis 70 to unfold appropriately around the periphery of the proximal end 1206 of the guidewire guard 1200. In some embodiments, the distal end of the prosthesis 70 may be longitudinally adjacent to the proximal end of the distal end 1204 (e.g., at step 1208) to provide longitudinal stop.

[0143] Figure 9BAn alternative embodiment of the guidewire guard 1200' with a more tapered configuration is shown. As shown, the proximal end 1206' of the guidewire guard 1200' may be a single radially outward tapered body 1208' extending to the distal end 1204' of the guidewire guard 1200', the distal end 1204' being generally cylindrical. The guidewire guard 1200' may also include a cavity 1202' for receiving the nasal cone shaft 27.

[0144] The nose cone assembly 31 is arranged so that it can slide independently relative to the other components. In addition, the nose cone assembly 31 can slide distally and proximally relative to the track assembly 22 together with the outer sheath assembly 22, the central shaft assembly 21 and the inner assembly 18.

[0145] In some embodiments, one or more spacer sleeves (not shown) may be used between different components of the delivery system 10. For example, spacer sleeves may be concentrically located between the central shaft assembly and the track assembly 20, generally between the midpoint 43 and the track tube 136. In some embodiments, spacer sleeves may be generally embedded in the tube 43 of the central shaft assembly 21, such as on the inner surface of the central shaft assembly 21. In some embodiments, spacer sleeves may be concentrically located between the track assembly 20 and the inner assembly 18, generally within the track tube 136. In some embodiments, spacer sleeves may be used between the outer sheath assembly 22 and the central shaft assembly 21. In some embodiments, spacer sleeves may be used between the inner assembly 18 and the nose cone assembly 31. In some embodiments, four, three, two, or one of the above-described spacer sleeves may be used. Spacer sleeves may be used in any of the above-described locations.

[0146] The spacer sleeve may be made of a polymeric material (such as woven Pebax®) and may be lined with, for example, PTFE on its inner diameter, but there are no specific material limitations. The spacer sleeve advantageously reduces friction between the maneuverable track assembly 20 and its surrounding components. Therefore, the spacer sleeve can act as a buffer between the track assembly 20 and the inner component 18 / nose cone assembly / 30. Furthermore, the spacer sleeve can occupy any radius of gap between the components, thereby preventing compression or snag of the components during maneuvering. In some embodiments, the spacer sleeve may include cuts or slots to facilitate bending of the spacer sleeve. In some embodiments, the spacer sleeve may not include any slots and may be a smooth cylindrical feature.

[0147] The spacer sleeve can be mechanically accommodated by other cavities and components, and thus non-physically attached to any other component, allowing the spacer sleeve to "float" in the region. This floating aspect of the spacer sleeve allows it to move to the desired location during deflection and provides a supporting and / or lubricating bearing surface / multiple bearing surfaces. Therefore, the floating aspect allows the delivery system 10 to maintain flexural force. However, in some embodiments, the spacer sleeve may be attached to other components.

[0148] Hypobo air tube / shaft construction As discussed above, the outer sheath assembly 22, central axis assembly 21, inner assembly 18, and track assembly 20 may respectively comprise an outer submersible tube 104, a central submersible tube, a distal segment 126, and a track submersible tube 136. Each of these submersible tubes / segments / axis can be laser-cut to include a plurality of slots, thereby creating a curved path for the delivery system. Although different slotted assemblies are discussed below, it should be understood that any submersible tube may have the slotted configuration discussed below. Figure 10-14 Different hysteresis tubes are shown in isolated form.

[0149] like Figure 10 As shown, the offshore waveguide 104 can generally be formed by one or more metal coils. In some embodiments, the offshore waveguide 104 can be formed by a near-side metal coil 107 and a far-side metal coil 108. For example... Figure 10 As shown, the proximal metal coil 107 and the distal metal coil 108 can be longitudinally separated by the tube portion 110. However, in some embodiments, the proximal metal coil 107 and the distal metal coil 108 are connected. The proximal metal coil 107 and the distal metal coil 108 may, for example, be connected to the outer surface of the tube portion 110 at the distal end of the proximal metal coil 107 and the proximal end of the distal metal coil 108 to form a complete outer submersible tube 104. In some embodiments, the proximal metal coil 107 and the distal metal coil 108 are substantially the same. In some embodiments, the proximal metal coil 107 and the distal metal coil 110 are different, for example, in terms of spacing between the coils, curvature, diameter, etc. In some embodiments, such as when the distal metal coil 108 forms a large diameter capsule 106, the diameter of the distal metal coil 108 is larger than that of the proximal metal coil 107. In some embodiments, they have the same diameter. In some embodiments, one or both of the metal coils 108 / 107 may form the capsule 106. The coil can be coated with a polymer layer, as described in detail below regarding the capsule construction. The coil construction allows the offshore waveguide 104 to follow a track in any desired direction.

[0150] Move radially inward, Figure 11-12B The central thiopanel tube 43 is shown to be a metal laser-cut thiopanel tube, such as a laser-cut nitinol thiopanel tube. Figure 12A Example Figure 11 The planar pattern. As shown in the figure, the sodium hypochlorite tube 43 may have multiple slots / holes cut into the sodium hypochlorite tube. In some embodiments, the cutting pattern may always be the same. In some embodiments, the central sodium hypochlorite tube 43 may have different sections, and different sections may have different cutting patterns.

[0151] For example, the proximal end of the central spool 43 may be a first segment 210 having a plurality of circumferentially extending slot pairs 213 spaced longitudinally along the first segment 211. Generally, two slots are cut around each circumferential location, forming nearly half a circumference. Thus, two backbones 215 extending along the length of the first segment 211 are formed between the slots 213. The slot pairs 213 may consist of a first thin slot 217. The second slot 221 of each slot pair 213 may be thicker than the first slot 217, such as 1, 2, 3, 4, or 5 times thicker. In some embodiments, the second slot 217 may have approximately the same longitudinal thickness throughout the slot. In some embodiments, each slot in the slot pair 213 may terminate in a teardrop shape 219 to facilitate bending.

[0152] Moving distally, the central sill tube 43 may include a second segment 220 having a plurality of slot pairs 222. Similar to the first segment 211, the second segment 220 may have a plurality of circumferentially extending slots spaced longitudinally along the second segment 220. Generally, two slots (e.g., a slot pair 222) are cut around each circumferential location, forming nearly half a circumference. Thus, a “trunk” 224 extending along the length of the second segment 220 is formed between the slots. Each slot pair 222 may include a first slot 226 that is generally thin and of no particular shape (e.g., it may look the same as slot 213 in the first segment 211) and a second slot 228 that is significantly thicker longitudinally than the first slot 226. The second slot 228 may be narrower at its ends and thicker longitudinally in its middle portion, thus forming a curved slot. Moving longitudinally along the second segment 220, each slot pair 222 may be offset by approximately 45 degrees or 90 degrees compared to its longitudinally adjacent slot pair 222. In some embodiments, the second slot pair 222 is offset by 90 degrees from the adjacent first slot pair 222, and the third slot pair 222 adjacent to the second slot pair 222 may have the same configuration as the first slot pair 222. This repeating pattern may extend along the length of the second segment 220, thereby providing a specific bending direction caused by the second slot 228 of the slot pair 222. Thus, the "trunk" 224 is displaced circumferentially due to the offset of the adjacent displaced slot pair 222. In some embodiments, each slot in the slot pair 222 may terminate in a teardrop shape 229 to facilitate bending.

[0153] Moving distally, the central axial submersible 43 may have a third section 230 having a plurality of slots. An outer retaining ring 240 may be attached to the distal end of the third section 230. The third section 230 may have circumferentially extending pairs of slots 232, each slot in the pair extending approximately halfway around the circumference to form two main sections 234. The pairs of slots 232 may consist of first thin slots 236, similar to slots 213 discussed in the first section 211. The second slots 238 in each pair of slots 232 may be thicker than the first slots 236, such as 1, 2, 3, 4, or 5 times thicker. In some embodiments, unlike the second slot 228 of the second section 220, the second slot 238 may have approximately the same longitudinal thickness throughout the slot. The first slot 236 and the second slot 238 may be circumferentially aligned along the length of the third segment 230, such that all first slots 236 are in the same circumferential position, and all second slots 238 are in the same circumferential position. The second slots 238 may be aligned with one of the circumferential positions of the second slots 228 of the second segment 220. In some embodiments, each slot in the slot pair 232 may terminate in a teardrop shape 239 to facilitate bending.

[0154] In some embodiments, the outer retaining ring reinforcement 240, which may partially or completely surround the outer retaining member 40 circumferentially, may also have multiple slots / holes / apertures, such as... Figure 11-1 As shown in Figure 2. This allows it to bend over curves, especially tight curves. In some embodiments, the distal end of the reinforcement 240 includes a plurality of generally circular / elliptical holes 242. This extends for approximately half the length of the reinforcement 240. On the proximal half, one circumferential half of the reinforcement 240 may include repeating thin slots 244 spaced apart by elongated oval holes 246. For example, two circumferentially spaced elongated oval holes 246 may be between the respective thin slots 244. In some embodiments, each of the slots 244 may terminate in a teardrop shape 249 to facilitate bending. On the other circumferential half of the proximal section, the reinforcement 240 may include a plurality of large slots 248, such as 1, 2, 3, 4, or 5 large slots 248 spaced longitudinally. The large slots 248 may be larger in the middle and narrow towards each circumferential end. The large slot 248 may include an end expansion 247 to promote flexibility.

[0155] Additionally, the outer retaining reinforcement 240 provides strength to reduce deployment forces, prevents the prosthesis 70 from being affected by any metal layer, and can increase strength. In some embodiments, the liner 240 may be a polymer (such as PTFE), but there are no limitations on the type of polymer or material. In some embodiments, the reinforcement 240 may be metal. In some embodiments, the reinforcement 240 may further include an outer polymer layer / jacket, such as a Pebax® jacket. This prevents the reinforcement 240 from getting stuck on the outer sheath assembly 22.

[0156] In some embodiments, the outer retaining ring 42 may further include an inner liner for a smooth transition over the prosthesis 70. The liner may be PTFE or etched PTFE, but the specific material is not limited and other friction-reducing polymers may be used. Figure 12B As shown, to prevent delamination during implant 70 loading, the liner 251 may be non-flush at the distal end of the outer retaining ring 42. Instead, the liner 251 may extend and invert at the distal end to cover the distal end of the outer retaining ring 42. In some embodiments, the liner 251 may also cover the outer surface of the reinforcement 240. This can form a seamless, rolled reinforcing tip of the liner 251. The liner 251 may completely or partially cover the outer surface of the outer retaining ring 42, for example, 1 / 4, 1 / 3, 1 / 2, 2 / 3, 3 / 4 (or greater than 1 / 4, 1 / 3, 1 / 2, 3 / 4) or all of the outer retaining ring 42. This solution is superior to previously known methods, such as those disclosed in U.S. Patent No. 6,622,367 (which is incorporated herein by reference in its entirety), because the application of PTFE liner does not provide particularly good adhesion to the reinforcement or jacket. By inverting the liner 251 and fusing it to the outer retaining ring 42 and / or the reinforcement 240 and / or the outer polymer sleeve on the reinforcement 240 / outer retaining ring 42, a seamless, reinforced end is formed that reduces delamination. Delamination is a serious problem because delaminated liners can tear and embolize during deployment, and delaminated layers can lead to extremely high loading and deployment forces. Delaminated layers can also cause cavity translation problems via the locking shaft, thus increasing the need for translational forces.

[0157] Next, move radially inward again. Figure 13An embodiment of the orbital wave tube 136 is shown (far end facing right). The orbital wave tube 136 may also include multiple circumferential slots. The orbital wave tube 136 can be generally divided into several distinct segments. At the closest end is an uncut (or ungrooved) wave tube segment 231. Moving further distally, the next segment is a near-grooved wave tube segment 133. This segment includes multiple circumferential slots cut into the orbital wave tube 136. Generally, two slots are cut around each circumferential location, forming almost half a circumference. Thus, two main trunks extending along the length of the wave tube 136 are formed between these slots. This is a segment that can be guided by the near-side drawstring 140. Moving further distally, there is a position 237 where the near-side drawstring 140 connects, thus avoiding the slots. Therefore, the segment is exactly distal to the near-side grooved segment.

[0158] Following the proximal filament connection region is the distally slotted submersible tube section 235. This section is similar to the proximal slotted submersible tube section 233, but has significantly more slots cut to equal lengths. Therefore, the distally slotted submersible tube section 235 offers easier bending than the proximal slotted submersible tube section 233. In some embodiments, the proximal slotted section 233 may be configured to undergo a bend of approximately 90 degrees with a half-inch radius, while the distally slotted section 135 may bend at approximately 180 degrees within half an inch. Furthermore, as... Figure 13 As shown, the ridge of the distally slotted submersible segment 235 is offset towards the ridge of the proximal slotted submersible segment 233. Therefore, the two segments will achieve different bending patterns, allowing for three-dimensional manipulation of the track assembly 20. In some embodiments, while the specific offset is not limited, the ridge may be offset by 30, 45, or 90 degrees. In some embodiments, the proximal slotted submersible segment 233 may include a compression coil. This allows the proximal slotted submersible segment 233 to maintain stiffness, enabling the distal slotted submersible segment 235 to undergo specific bending.

[0159] At the far end of the grooved submersible section 235 is the far-side traction wire connection area 241, which is also the non-grooved section of the track submersible 136.

[0160] Move radially inward, in Figure 14In this configuration, the inner component 18 generally comprises two sections. The proximal section is a slotted or unslotted thiocyanate tube 129. The distal section 126, which at least partially overlaps the outer surface of the proximal thiocyanate tube 129, can be designed to be particularly flexible. For example, the distal section 126 can be more flexible than any other shaft discussed herein. In some embodiments, the distal section 126 can be more flexible than any shaft discussed herein, except for the nose cone shaft 27. In some embodiments, the distal section 126 can be a flexible tube or a thiocyanate tube. In some embodiments, the distal section 126 can be a cable, such as a flexible cable. For example, a cable can be several strands of wire, such as metal, plastic, polymer, ceramic, etc., wound together to form a rope or cable. Because the cable is so flexible, it can be more easily bent along with the track assembly 20. Furthermore, the cable can be smooth, which allows the track assembly 20 to track above a smooth surface, thereby eliminating the need for any liner on the track assembly 20.

[0161] Capsule structure The capsule body 106 may be formed of one or more materials, such as PTFE, ePTFE, polyether block amide (Pebax®), polyether imide (Ultem®), PEEK, urethane, nickel-titanium, stainless steel, and / or any other biocompatible material. The capsule body is preferably compliant and flexible while still maintaining a sufficient degree of radial strength to hold the replacement valve within the capsule body 106 without significant radial deformation, which could increase friction between the capsule body 106 and the replacement valve 70 contained therein. The capsule body 106 also preferably has sufficient column strength to resist buckling of the capsule body and sufficient tear resistance to reduce or eliminate the possibility of tearing of the replacement valve and / or damage to the capsule body 106. Flexibility of the capsule body 106 can be advantageous, particularly for via-spaced paths. For example, when retracting along a curved member, such as when tracking over the track assembly described herein, the capsule body 106 can bend to follow the curved member without exerting large forces on it, which would cause the curved member to reduce its radius. More specifically, when the capsule body 106 retracts along such a curved member, the capsule body 106 can bend and / or twist such that the radius of the curved member is substantially unaffected.

[0162] Figure 15 An embodiment of a capsule body 106 that can be used with an embodiment of delivery system 10 is shown. The capsule body 106 may include any of the materials and properties discussed above. In the case of multiple implant capsule bodies, compressibility and flexibility are generally balanced, as improved flexibility leads to poorer compressibility. Therefore, a choice is tended between compressibility and flexibility. However, an embodiment of a capsule body 106 that achieves both high compressibility and high flexibility is disclosed. Specifically, the capsule body 106 can be bent in multiple directions.

[0163] Specifically, the metallic thiocyanate tube provides radial strength and compressive strength, while specific slots / cutouts in the thiocyanate tube allow for flexibility in the capsule body 106. In some embodiments, a thin liner and sheath (such as a polymer layer) may surround the capsule body 106 to prevent any negative interactions between the implant 70 and the capsule body 106.

[0164] In some embodiments, the capsule body 106 may have the following characteristics: Figure 15 The specific construction shown allows it to achieve advantageous properties. The capsule body 106 can be made of several different layers to provide these properties.

[0165] In some embodiments, the capsule body 106 may be formed of a metal layer 402, which gives the capsule body 106 its structure. This metal layer may include, but is not limited to, the metal layer that provides the capsule body 106 with its structure. Figure 10 The coil in question could be one or more sodium thiosulfate tubes. The capsule body 106 is then covered with a polymer layer on its outer surface and a liner on its inner surface. All these features will be discussed in detail below.

[0166] As described above, the metal layer 404 can be, for example, a metal thiopanel tube or a laser-cut thiopanel tube. In some embodiments, the metal layer 404 can be as described above. Figure 10 The metal coil or spiral discussed in detail. Although there are no limitations, the metal layer 404 may have a thickness of 0.007 inches (or about 0.007 inches).

[0167] If using, such as Figure 10 The metal coil shown can have a uniform coil size along the entire length of metal layer 404. However, in some embodiments, the coil size can vary along the length of metal layer 404. For example, the coil can vary between a coil with a 0.014-inch gap and a 0.021-inch pitch (e.g., a small coil), a coil with a 0.020-inch gap and a 0.02-inch pitch (e.g., a large coil), and a coil with a 0.020-inch gap and a 0.027-inch pitch (e.g., a large coil with a large gap). However, these specific dimensions are merely examples, and other designs may be used.

[0168] The farthest end of metal layer 404 may be formed by a small coil. Moving proximally, metal layer 404 may then transition to a large coil segment, followed by a small coil segment, and finally, the closest segment may be a spaced-out large coil. As an example set of lengths, but not limited to, the length of the farthest small coil segment may be 10 mm (or about 10 mm). Moving proximally, the length of the adjacent large coil segment may extend from 40 mm (or about 40 mm) to 60 mm (or about 60 mm). These two segments may be... Figure 10It is found in the distal metal coil 108 shown. Move to Figure 10 The proximal metal coil 107 shown may have a small coil segment with a length of 10 mm (or about 10 mm). The remainder of the proximal metal coil 107 may be spaced large coil segments. The length of the spaced large coil segments may be 40 mm (or about 40 mm) to 60 mm (or about 60 mm) or longer.

[0169] As described, the metal layer 404 (coil or hyaluronic acid tube) may be covered by an outer polymer layer or a sleeve 402. In some embodiments, the outer polymer layer 402 is an elastomer, but the specific material is not limited. In some embodiments, the outer polymer layer 402 may comprise polytetrafluoroethylene (PTFE) or expanded polytetrafluoroethylene (ePTFE). ePTFE may have very different mechanical properties than PTFE. For example, ePTFE may have much greater flexibility while still maintaining good tensile / elongation properties. In some embodiments, the outer polymer layer 402 may comprise a thermoplastic elastomer, such as PEBAX®. In some embodiments, the outer polymer layer 402 may be pre-stressed axially before being applied to the capsule body. The thickness of the outer polymer layer 402 may be approximately 0.006 to 0.008 inches, but the specific thickness is not limited.

[0170] The outer polymer layer 402 can be applied to the metal layer 404 to form an outer jacket, for example, by polymer reflow soldering. In some embodiments, the outer polymer layer 402 can be applied directly to the metal layer 404. In some embodiments, an adhesive layer 406 can be disposed between the metal layer 404 and the outer polymer layer 402 to promote adhesion between the outer polymer layer and the metal layer. For example, a fluoropolymer or other fluoropolymer with varying stiffness can be applied between the metal layer 404 and the outer layer 402 to attach the two layers together and prevent delamination. In some embodiments, no adhesive layer 406 is used.

[0171] In some embodiments, additional materials may be included between the metal layer 404 and the outer polymer layer 402 to improve properties. For example, fluorinated ethylene propylene (FEP) segment 408 can improve radial strength, particularly when the implant is in a compression configuration. Although FEP layer 408 has been discussed as a specific material, other high-strength polymers, metals, or ceramics may also be used, and there are no limitations on the specific material. In some cases, FEP layer 408 may also act as an adhesive.

[0172] FEP segment 408 may be included at the distal and proximal ends of capsule body 106. FEP segment 408 may overlap with adhesive layer 406. Therefore, FEP segment 408 may be located between adhesive layer 406 and metal layer 404, or between adhesive layer 406 and outer polymer layer 402. In some embodiments, FEP segment 408 may be located in a segment of capsule body 106 that does not include adhesive layer 406.

[0173] Since there is no specific length limitation, the FEP segment 408 located at the distal end of the capsule body 106 may have a length of 10 mm (or about 10 mm). In some embodiments, the thickness of the FEP segment 408 is about 0.003 inches, but this thickness can vary and is not limited to this disclosure. In some embodiments, different FEP segments 408 (e.g., proximal segments and distal portions) may have different thicknesses. In some embodiments, all FEP 408 layers have the same thickness. Exemplary thicknesses may be 0.006 inches or 0.003 inches.

[0174] Moving into the interior of the metal layer 404, the liner 410 may be included on its radially inner surface. The liner 410 may be formed of a low-friction and / or highly lubricating material, which allows the capsule 106 to translate over the prosthesis 70 without jamming or damaging any part of the prosthesis 70. In some embodiments, the liner 410 may be PTFE, which resists radial expansion and reduces friction with the prosthesis 70.

[0175] In some embodiments, the liner 410 is made of ePTFE. However, it can be difficult to reflow solder a standard ePTFE liner 410 onto the inner layer of the capsule body 106. Therefore, the ePTFE liner layer 410 can be pre-compressed before being applied to the inner layer of the capsule body 106. In some embodiments, portions of the outer polymer layer 402 and the liner 410 may be in contact with each other. Therefore, the ePTFE liner 410 and / or the outer polymer layer 402 can be axially compressed before the two layers are bonded together. These layers can then be bonded together using a reflow soldering technique during manufacturing. For example, the ePTFE liner 410 may be axially compressed, such as over a mandrel, while the outer polymer layer 402 may be placed on top of it. The two layers can then be reflow soldered (e.g., melted under pressure) to join them. The combined layers may slide into and / or around the metal layer 404 discussed herein and may be melted again under pressure to form the final capsule body 106. This technique allows the capsule body 106 to maintain flexibility and prevent breakage / tear.

[0176] As described, in some embodiments, the liner 410 may be ePTFE. The surface friction of ePTFE may be about 15% less than that of standard PTFE, and about 40% less than that of standard extruded thermoplastics used in the art.

[0177] In some embodiments, the liner layer 410 may extend only along the inner surface of the capsule body 106 and terminate at the distal end. However, to prevent delamination during implant 70 loading, the liner 410 may not be flush at the distal end of the capsule body 106. Instead, the liner 410 may extend and invert at the distal end to cover the distal end of the capsule body 106 and a portion of the outer diameter of the outer polymer layer 402. This forms a seamless, rolled, reinforcing tip of the liner 410. This solution is superior to previously known methods, such as those disclosed in U.S. Patent No. 6,622,367 (which is incorporated herein by reference in its entirety), because the application of PTFE liner does not provide particularly good adhesion to the reinforcement or jacket. By inverting the liner 410 and fusing it with the outer polymer layer 402, this forms a seamless, reinforced capsule body that reduces delamination. Delamination is a serious problem because a delaminated liner can tear and embolize during deployment, and delaminated layers can result in extremely high loading and deployment forces. Layered structures can also cause cavity translation problems by locking the shaft, thus increasing the need for translation force.

[0178] In some embodiments, another FEP section 412 may be included between the liner 410 and the metal layer 404. The FEP section 412 may be located on the distal metal coil 108, and the tube 110 transitions between the distal metal coil 108 and the proximal metal coil 107. In some embodiments, the FEP section 412 may extend partially or completely into the proximal metal coil 107.

[0179] In some embodiments, the FEP segment 412 may be included in the nearest-side portion of the near-side metal coil 107. This FEP segment 412 is approximately 0.5 inches in length. In some embodiments, a longitudinal gap extending over the far-side metal coil 108 exists between the nearest-side FEP segment 412 and the FEP segment 412. In some embodiments, the previously mentioned FEP segment 412 is continuous.

[0180] like Figure 15 As shown, the metal layer 404 may stop near the edge of the outer polymer layer 402, liner 410, and FEP segment 412. If so, a thicker portion of the adhesive layer 409 may be applied at the distal end of the metal layer 404 to match the distal ends of the other layers. However, this segment may be removed during manufacturing, so the distal end of the metal layer 404 is the distal end of the capsule body 106, which can then be covered by the liner 410. In some embodiments, the extended segment distal to the metal layer 404 is not used.

[0181] handle The handle 14 is located at the proximal end of the delivery system 10, and as... Figure 16 As shown in the figure. The cross-section of handle 14 is in Figure 17 As shown in the diagram. Handle 14 may include multiple actuators (such as rotatable knobs) that can manipulate different components of delivery system 10. The operation of handle 10 is described with reference to the delivery of mitral valve replacement prosthesis 70, but handle 10 and delivery system 10 may also be used to deliver other devices.

[0182] The handle 14 generally comprises two housings—a track housing 202 and a delivery housing 204, with the track housing 202 arranged circumferentially around the delivery housing 204. The inner surface of the track housing 202 may include a screwable section configured to engage with the outer surface of the delivery housing 204. Thus, as described in detail below, the delivery housing 204 is configured to slide (e.g., screw) within the track housing 202. The track housing 202 extends approximately half the length of the delivery housing 204, thus the delivery housing 204 extends to the exterior of the track housing 202 both proximally and distally.

[0183] The track housing 202 may include two rotatable knobs—a distal traction wire knob 206 and a proximal traction wire knob 208. However, the number of rotatable knobs on the track housing 202 may vary depending on the number of traction wires used. Rotation of the distal traction wire knob 206 provides a proximal force, thereby providing axial tension on the distal traction wire 138 and bending the distal slotted section 135 of the track hysteresis tube 136. The distal traction wire knob 206 can be rotated in either direction, thus allowing bending in either direction, which controls the front-to-back angle. Rotation of the proximal traction wire knob 208 provides a proximal force on the proximal traction wire 140, and thus provides axial tension, thereby bending the proximal slotted section 133 of the track hysteresis tube 136, thus controlling the inside-to-outside angle. The proximal traction wire knob 208 can be rotated in either direction, thus allowing bending in either direction. Therefore, when both knobs are actuated, two bends exist in the track tube 136, allowing for three-dimensional manipulation of the track axis 132, thereby enabling three-dimensional manipulation of the distal end of the delivery system 10. Furthermore, the proximal end of the track axis 132 is connected to the inner surface of the track housing 202.

[0184] The bending of the track axis 132 can be used to position the system, particularly the distal end, at the desired patient location, such as at the natural mitral valve. In some embodiments, rotation of the traction wire knobs 206 / 208 can help maneuver the distal end of the delivery system 10 through the septum and left atrium and into the left ventricle, so that the prosthesis 70 is positioned at the natural mitral valve.

[0185] Upon moving to the delivery housing 204, the proximal ends of the inner shaft assembly 19, outer sheath assembly 22, central shaft assembly 21, and nose cone shaft assembly 30 can be connected to the inner surface of the delivery housing 204 of the handle 14. Therefore, they can move axially relative to the track assembly 20 and the track housing 202.

[0186] A rotatable outer sheath knob 210 may be located on the distal end of the delivery housing 204, distal to the track housing 202. Rotation of the outer sheath knob 210 will pull the outer sheath assembly 22 proximally in the axial direction, thereby pulling the capsule body 106 away from the implant 70 and releasing the distal end 301 of the implant 70. Thus, the outer sheath assembly 22 translates independently relative to the other axes in the delivery system 10. The distal end 303 of the implant 70 may be released first, while the proximal end 301 of the implant 70 may still be radially compressed between the inner retainer 40 and the outer retainer 42.

[0187] A rotatable central axis knob 214 may be located on the delivery housing 204. In some embodiments, the rotatable central axis knob 214 is proximal to the rotatable outer sheath knob 210 and distal to the track housing 202. Rotation of the central axis knob 212 will pull the central axis assembly 212 proximally in the axial direction, thereby pulling the outer retaining ring 42 away from the implant 70 and exposing the inner retaining member 40 and the proximal end 301 of the implant 70, thereby releasing the implant 70. Thus, the central axis assembly 21 translates independently relative to the other axes in the delivery system 10.

[0188] A rotatable depth knob 212 may be located on the proximal end of the delivery housing 204, and thus on the proximal side of the track housing 202. When the depth knob 212 is rotated, the entire delivery housing 204 moves distally or proximally relative to the track housing 202, which remains in the same position. Thus, at the distal end of the delivery system 10, the inner shaft assembly 18, outer sheath assembly 22, central shaft assembly 21, and nasal cone assembly 31 move together (e.g., simultaneously) proximally or distally relative to the track assembly 20, while the implant 70 remains in a compressed configuration. In some embodiments, actuation of the depth knob 212 may cause the inner shaft assembly 18, outer sheath assembly 22, central shaft assembly 21, and nasal cone assembly 31 to move sequentially relative to the track assembly 20. In some embodiments, actuation of the depth knob 212 may cause the inner shaft assembly 18, outer sheath assembly 22, and central shaft assembly 21 to move together relative to the track assembly 20. Therefore, the track axis 132 can be aligned in a specific direction, and other components can be moved distally or proximally relative to the track axis 132 for final positioning without releasing the implant 70. These components can be advanced approximately 1, 2, 3, 5, 6, 7, 8, 9, or 10 centimeters along the track axis 132. These components can be advanced more than approximately 1, 2, 3, 5, 6, 7, 8, 9, or 10 centimeters along the track axis 132. One such example is... Figure 2CThe image is shown in the image. Then, as discussed above, in some embodiments, the capsule body 106 and the outer retaining ring 42 can be retracted individually relative to the inner component 18, thereby sequentially releasing the implant 70 in some embodiments. The components other than the track assembly 20 can then be retracted above the track axis 132 by rotating the depth knob 212 in the opposite direction.

[0189] The handle 14 may further include a mechanism (knob, button, handle) 216 for moving the nasal cone axis 27 and thus the nasal cone 28. For example, the knob 216 may be part of the nasal cone assembly 31 extending proximally from the handle 14. Thus, a user can pull or push the knob 216 to translate the nasal cone axis 27 distally or proximally relative to other axes. This is advantageous for proximally translating the nasal cone 28 into the outer sheath assembly 22 / capsule body 106, thereby facilitating the withdrawal of the delivery system 10 from the patient.

[0190] In some embodiments, the handle 14 may provide a lock 218 (such as a spring lock) to prevent the nasal conus shaft 27 from being translated by the knob 216 discussed above. In some embodiments, the lock 218 may always be active, so that the nasal conus shaft 27 will not move unless the user disengages the lock 218. The lock may be, for example, a spring lock that is engaged before the button 218 on the handle 14 is pressed, thereby releasing the spring lock and allowing the nasal conus shaft 27 to translate proximally / distally. In some embodiments, the spring lock 218 allows unidirectional movement of the nasal conus shaft 27 (proximal or distal movement) but prevents movement in the opposite direction.

[0191] The handle 14 may further include communicating flushing ports for flushing the different cavities of the delivery system 10. In some embodiments, a single flushing port on the handle 14 may provide fluid connection to multiple components. In some embodiments, the flushing port may provide fluid connection to the outer sheath assembly 22. In some embodiments, the flushing port may provide fluid connection to the outer sheath assembly 22 and the central shaft assembly 21. In some embodiments, the flushing port may provide fluid connection to the outer sheath assembly 22, the central shaft assembly 21, and the track assembly 20. In some embodiments, the flushing port may provide fluid connection to the outer sheath assembly 22, the central shaft assembly 21, the track assembly 20, and the inner component 18. Thus, in some embodiments, the track shaft 132, the outer retaining ring 42, and the capsule body 406 may all be flushed through a single flushing port.

[0192] Valve delivery positioning A method using a delivery system 10 combined with a mitral valve replacement will now be described. Specifically, the delivery system 10 can be used for percutaneous delivery of a mitral valve replacement to treat patients with moderate to severe mitral regurgitation. The following methods are merely examples of how the object system can be used. It will be understood that the delivery system described herein can also be used as part of other methods.

[0193] like Figure 18 As shown, in one embodiment, the delivery system 10 may be placed in the ipsilateral femoral vein 1074 and advanced toward the right atrium 1076. A transseptal puncture using known techniques may then be performed to access the left atrium 1078. The delivery system 10 may then be advanced into the left atrium 1078 and subsequently into the left ventricle 1080. Figure 18 A delivery system 10 extending from the ipsilateral femoral vein 1074 to the left atrium 1078 is shown. In embodiments of this disclosure, no guidewire is required to position the delivery system 10 in place; however, in other embodiments, one or more guidewires may be used.

[0194] Therefore, it is advantageous for the user to be able to manipulate the delivery system 10 through complex areas of the heart to position the replacement mitral valve in line with the native mitral valve. This task can be performed with or without a guidewire using the system disclosed above. The distal end of the delivery system can be advanced into the left atrium 1078. The user can then manipulate the track assembly 20 to target the distal end of the delivery system 10 to the appropriate area. The user can then continue to advance the curved delivery system 10 into the left atrium 1078 via a transseptal puncture. The user can then further manipulate the delivery system 10 to create greater curvature in the track assembly 20. Furthermore, the user can twist the entire delivery system 10 to further manipulate and control its position. The user can then position the replacement mitral valve in the appropriate location with the fully curved configuration. This advantageously allows for delivery of the replacement valve to the orthotopic implantation site, such as the native mitral valve, via a wider range of pathways, such as the transseptal pathway.

[0195] The track assembly 20 is particularly advantageous for accessing the natural mitral valve. As discussed above, the track assembly 20 can form two bends, both of which can be located in the left atrium 1078. The bends in the track assembly 20 can position the prosthesis 70 located in the implant retention region 16, such that the prosthesis 70 is coaxial with the natural mitral valve. As discussed below, once the prosthesis 70 is coaxial, the outer sheath assembly 22, the central axis assembly 21, the inner assembly 18, and the nasal cone assembly 31 can be advanced distally relative to the track assembly 20 (e.g., using the depth knob 212 of the handle 14). These components are continuously pushed away from the track assembly 20, thereby advancing them to coaxiality with the natural mitral valve until the prosthesis 70 is to be released while maintaining the prosthesis 70 in a compressed configuration. Thus, the track assembly 20 provides the user with the ability to lock the angular position in place, allowing the user to then only need to advance the other components longitudinally above the track assembly 20 without making any angle changes, thus greatly simplifying the procedure. The track assembly 20 acts as a standalone maneuvering component, where all other components simply provide maneuverability and do not offer further prosthesis release functionality. Furthermore, the track assembly 20, as described above, is constructed rigidly enough that when the track assembly is actuated to its curved shape, the movement of other components (e.g., the outer sheath assembly 22, the central axis assembly 21, the inner assembly 18, and / or the nasal cone assembly 31, and the track assembly 20) maintains their shape. Therefore, while other components slide relative to the track assembly 20, the track assembly 20 can remain in the desired curved position, and the track assembly 20 can assist in guiding the other components to their final position. Proximal / distal translation of the other components above the track assembly 20 allows for ventricular / atrial movement. Additionally, once the distal anchor 80 of the prosthesis 70 has been released in the left ventricle 1080, but before full release, the other components can retract proximally above the track assembly 20 to capture any lobules or chordae tendineae.

[0196] Now for reference Figure 19 This illustration shows a portion of an implementation of a replacement heart valve (prosthesis 70) positioned within the natural mitral valve of the heart 83. Further details regarding how the prosthesis 70 can be positioned at the natural mitral valve are described in U.S. Publication No. 2015 / 0328000A1, the entire contents of which are incorporated herein by reference, including but not limited to... Figure 13 A-15 and Embodiments 28-37. A portion of a natural mitral valve, representing typical anatomy, is schematically shown, comprising a left atrium 1078 located above the valve annulus 1106 and a left ventricle 1080 located below the valve annulus 1106. The left atrium 1078 and the left ventricle 1080 communicate with each other via the mitral valve annulus 1106. Figure 19The diagram also schematically shows a natural mitral valve leaflet 1108 with chordae tendineae 1110, which connects the downstream end of the mitral valve leaflet 1108 to the papillary muscle of the left ventricle 1080. The portion of the prosthesis 70 positioned upstream of the valve annulus 1106 (towards the left atrium 1078) may be referred to as being located above the annulus. The portion approximately within the valve annulus 1106 may be referred to as being located within the annulus. The portion downstream of the valve annulus 1106 may be referred to as being located below the annulus (towards the left ventricle 1080).

[0197] like Figure 19 As shown, a replacement heart valve (e.g., prosthesis 70) can be positioned such that the mitral valve annulus 1106 is located between the distal anchor 80 and the proximal anchor 82. In some cases, the prosthesis 70 may, for example... Figure 19 The distal anchor 80 is positioned such that its end or tip contacts the leaflet 1106. In some cases, the prosthesis 70 may be positioned such that the end or tip of the distal anchor 80 does not contact the leaflet 1106. In some cases, the prosthesis 70 may be positioned such that the distal anchor 80 does not extend around the leaflet 1108.

[0198] like Figure 19 As exemplified, the replacement heart valve 70 can be positioned such that the distal end or tip of the distal anchor 80 is on the ventricular side of the mitral annulus 1106, while the distal end or tip of the proximal anchor 82 is on the atrial side of the mitral annulus 1106. The distal anchor 80 can be positioned such that the distal end or tip of the distal anchor 80 extends beyond the free end of the chordae tendineae 1110 connected to the natural leaflet and is on the ventricular side of the natural leaflet. The distal anchor 80 can extend between at least some of the chordae tendineae 1110, and in some cases (such as...) Figure 19 In the cases shown, the distal anchor 80 may contact or engage the ventricular side of the valve annulus 1106. It is also considered that in some cases, while the distal anchor 80 may still contact the natural leaflet 1108, the distal anchor 80 may not contact the valve annulus 1106. In some cases, the distal anchor 80 may contact the tissue of the left ventricle 104 beyond the ventricular side of the valve annulus 1106 and / or leaflet.

[0199] During delivery, the distal anchor 80 (together with the frame) may be moved toward the ventricular side of the valve annulus 1106, for example, by translating other components (e.g., outer sheath assembly 22, central axis assembly 21, inner assembly 18, and nasal cone assembly 31) proximally relative to the track assembly 20, wherein the distal anchor 80 extends between at least some of the chordae tendineae 1110 to provide tension on the chordae tendineae 1110. The degree of tension provided on the chordae tendineae 1110 may vary. For example, there may be very little tension or no tension in the chordae tendineae 1110, wherein the size of the leaflet 1108 is smaller than or approximately the size of the distal anchor 80. There may be a greater degree of tension in the chordae tendineae 1110, wherein the leaflet 1108 is longer than the distal anchor 80 and therefore takes a compact form and is pulled proximally. There may be an even greater degree of tension in the chordae tendineae 1110, wherein the leaflet 1108 is even longer relative to the distal anchor 80. Leaflet 1108 can be long enough so that the distal anchor 80 does not contact the annulus 1106.

[0200] Proximal anchors 82 (if present) may be positioned such that the tip or end of the proximal anchor 82 extends beyond the valve annulus 1106 and is adjacent to the atrial side and / or left atrium 1078 of the valve annulus 1106. In some cases, some or all of the proximal anchors 82 may extend beyond the valve annulus 1106 and only occasionally contact or engage the atrial side and / or left atrium 1078 of the valve annulus 1106. For example, as Figure 19 As exemplified, the proximal anchor 82 may extend beyond the valve annulus 1106 to contact the tissue of the atrial side and / or left atrium 1078 of the valve annulus 1106. The proximal anchor 82 may provide axial stability for the prosthesis 70. It is also considered that some or all of the proximal anchors 82 may extend beyond the valve annulus 1106 to contact the tissue of the atrial side and / or left atrium 1078 of the valve annulus 1106. Figure 20 An example of a prosthesis 70 implanted in the heart is shown. Although the example replacement heart valve includes both proximal and distal anchors, it should be understood that both proximal and distal anchors are not necessary in all cases. For example, a replacement heart valve with only a distal anchor may be able to hold the replacement heart valve securely within the valve annulus. This is because during cardiac systole, the greatest force on the replacement heart valve points towards the left atrium. Therefore, the distal anchor is most important for anchoring the replacement heart valve within the valve annulus and preventing migration.

[0201] Delivery method Figure 21-23 An example of the release mechanism of the delivery system 10 is shown. During the initial insertion of the prosthesis 70 and the delivery system 10 into the body, the prosthesis 70 may be located within the system 10, similar to... Figure 2AAs shown in the diagram, the distal end 303 of the prosthesis 70, and specifically the distal anchor 80, is restrained within the capsule body 106 of the outer sheath assembly 22, thereby preventing expansion of the prosthesis 70. Similar to... Figure 2A As shown, when positioned within the capsule body, the distal anchor 80 can extend distally. The proximal end 301 of the prosthesis 70 is constrained within the capsule body 106 and within a portion of the inner retaining member 40, and is therefore substantially constrained between the capsule body 106 and the inner retaining member 40.

[0202] By using the manipulation mechanism or other techniques discussed herein, the system 10 can first be positioned in a specific location within the patient's body, such as at the natural mitral valve.

[0203] Once the prosthesis 70 is loaded into the delivery system 10, the user can insert a guidewire into the patient's body to the desired location. The guidewire passes through the cavity of the nasal cone assembly 31, so the delivery system 10 can generally be advanced through the patient's body following the guidewire. The delivery system 10 can be advanced by the user manually moving the handle 14 in the axial direction. In some embodiments, the delivery system 10 can be placed on a stand while the handle 14 is being operated.

[0204] Once roughly inside the heart, the user can begin manipulating the track assembly 20 using the distal traction wire knob 206 and / or the proximal traction wire knob 208. By turning either knob, the user can provide flexion / bending (distal or proximal) of the track assembly 20, thereby bending the distal end of the delivery system 10 into a desired configuration at one, two, or more locations. As discussed above, the user can provide multiple bends in the track assembly 20 to guide the delivery system 10 toward the mitral valve. Specifically, the bends in the track assembly 20 can guide the distal end of the delivery system 10 along the central axis passing through the natural mitral valve, and thus guide the capsule body 106. Thus, when the prosthesis 70 is compressed, and the outer sheath assembly 22, central axis assembly 21, inner assembly 18, and nasal cone assembly 31 are advanced together above the track assembly 20, the capsule body 106 travels directly to alignment with the axis to properly release the prosthesis 70.

[0205] The user can also rotate and / or move the handle 14 itself within the support to further tune the distal end of the delivery system 10. The user can continuously rotate the proximal traction wire knob 208 and / or the distal traction wire knob 206, and move the handle 14 itself, to orient the delivery system 10, thereby releasing the prosthesis 70 into the body. The user can also further move other components relative to the track assembly 20, such as proximally or distally.

[0206] In the next step, the user can rotate the depth knob 212. As discussed, rotation of this knob 212 advances the inner shaft assembly 18, the central shaft assembly 21, the outer sheath assembly 22, and the nasal cone assembly 31 together above / through the track assembly 20, while the prosthesis 70 remains in a compressed configuration within the implant retention region 16. Due to the rigidity of, for example, the inner shaft assembly 18, the central shaft assembly 21, and / or the outer sheath assembly 22, these assemblies travel straight forward in a direction aligned with the track assembly 20.

[0207] Once in the release position, the user can rotate the outer sheath knob 210, which causes the outer sheath assembly 22 to translate independently in a proximal direction relative to other components (particularly the inner assembly 18) toward the handle 14 (and thus translate the capsule body 106), as... Figure 21 As shown in the diagram. By doing so, the distal end 303 of the prosthesis 70 is exposed within the body, thereby allowing the initiation of dilation. At this point, the distal anchor 80 can be flipped proximally, and the distal end 303 begins to dilate radially outward. For example, if the system 10 has been delivered to the natural mitral valve location via a transseptal path, the nasal cone is positioned in the left ventricle, preferably with the prosthesis 70 aligned such that the prosthesis 70 is substantially perpendicular to the plane of the mitral annulus. The distal anchor 80 dilates radially outward within the left ventricle. The distal anchor 80 may be located above the papillary head, but below the mitral annulus and mitral leaflets. In some embodiments, the distal anchor 80 may contact the chordae tendineae in the left ventricle and / or extend between the chordae tendineae, and contact the leaflets as the distal anchor 80 dilates radially. In some embodiments, the distal anchor 80 may not contact the chordae tendineae and / or not extend between the chordae tendineae or contact the leaflets. Depending on the location of the prosthesis 70, the distal end of the distal anchor 80 may be located at or below the free edge where the chordae tendineae connect to the natural leaflet.

[0208] As shown in the example embodiment, the distal end 303 of the prosthesis 70 expands outward. It should be noted that during this step, the proximal end 301 of the prosthesis 70 may still be covered by the outer retaining ring, such that the proximal end 301 remains in a radially compressed configuration. At this point, the system 10 may be retracted proximally, causing the distal anchor 80 to capture and engage the mitral leaflet, or it may be moved proximally to reposition the prosthesis 70. For example, the assembly may be moved proximally relative to the track assembly 20. Furthermore, the system 10 may be twisted, which may cause the distal anchor 80 to apply tension to the chordae tendineae, at least some of which may extend between the chordae tendineae by tension. However, in some embodiments, the distal anchor 80 may not apply tension to the chordae tendineae. In some embodiments, after the outer sheath assembly 22 is withdrawn, the distal anchor 80 may capture the natural leaflet and may be positioned between the chordae tendineae without causing any further movement of the system 10.

[0209] During this step, system 10 can be moved proximally or distally to properly capture the natural mitral valve leaflet with the distal or ventricular anchor 80. This can be accomplished by moving the outer sheath assembly 22, central axis assembly 21, inner assembly 18, and nasal cone assembly 31 relative to the track assembly 20. In particular, the distal end of the ventricular anchor 80 can be moved proximally to engage the ventricular side of the natural valve annulus, such that the natural leaflet is positioned between the anchor 80 and the body of the prosthesis 70. When the prosthesis 70 is in its final position, although the distal anchor 80 may be located between at least some of the chordae tendineae, there may or may not be tension on the chordae tendineae.

[0210] After the capsule body 106 retracts, the proximal end 301 of the prosthesis 70 will remain within the outer retaining ring 42. For example... Figure 22 As shown, once the distal end 303 of the prosthesis 70 is fully dilated (or as fully dilated as possible at this point), the outer retaining ring 42 can be withdrawn proximally alone relative to the other components (particularly relative to the inner component 18) to expose the inner retaining member 40, thereby initiating dilation of the proximal end 301 of the prosthesis 70. For example, in a mitral valve replacement procedure, the proximal end 301 of the prosthesis 70 can dilate in the left atrium after the distal or ventricular anchor 80 has been positioned between at least some of the chordae tendineae and / or engaged with the natural mitral valve annulus.

[0211] The outer retaining ring 42 can move proximally, allowing the proximal end 310 of the prosthesis 70 to expand radially to its fully expanded configuration, such as... Figure 23 As shown in the diagram. After the prosthesis 70 expands and expands, the inner component 18, nasal cone assembly 31, central axis assembly 21, and outer sheath assembly 22 can be simultaneously retracted proximally to their original positions along or relative to the track assembly 20. In some embodiments, they are not retracted relative to the track assembly 20 but remain in the expanded position. Furthermore, the nasal cone 28 can be retracted through the center of the expanded prosthesis 70 and into the outer sheath assembly 22, for example, by translating the knob 216 proximally. The system 10 can then be removed from the patient.

[0212] Figure 24A -B illustrates the propulsion of different components above track component 20. Figure 24A An example component is shown, positioned on its nearest side above track component 20. Figure 24B Examples of components are provided, and components are in relation to, for example, Figure 2C The track assembly 20 shown is positioned relative to its farthest side. Therefore, these components zigzag along the track assembly 20 and extend to the farthest side.

[0213] In some implementations, the prosthesis 70 can be delivered under fluorescence examination, allowing the user to observe certain reference points and thus properly position the prosthesis 70. Additionally, echocardiography can be used for proper positioning of the prosthesis 70.

[0214] The following is a discussion of alternative implantation methods for delivering a replacement mitral valve to the mitral valve location. Elements described below can be incorporated into the above discussion, and vice versa. Before insertion of the delivery system 10, the entry site into the patient can be dilated. Additionally, the dilator can be flushed with, for example, heparinized saline before use. The delivery system 10 can then be inserted over the guidewire. In some embodiments, any flushing ports on the delivery system 10 can be vertically oriented. Furthermore, if a guide tube is used (integrated or otherwise), this guide tube can be stabilized. The delivery system 10 can be advanced through the septum until the distal end of the delivery system 10 is positioned across the septum in the left atrium 1078. Thus, the distal end of the delivery system 10 can be located in the left atrium 1078. In some embodiments, the delivery system 10 can be rotated into the desired position, such as under fluoroscopic guidance. The track can be flexed so that the distal end of the delivery system 10 can be guided toward the septum and the mitral valve. Echocardiography and fluoroscopic guidance can be used to verify the position of the delivery system 10 and the prosthesis 70 within it.

[0215] In some embodiments, the prosthesis 70 may be positioned above, aligned with, or below the mitral annulus 1106 before deployment. In some embodiments, the prosthesis 70 may be completely above, aligned with, directly below, or completely below the mitral annulus 1106 before dilation. In some embodiments, the prosthesis 70 may be partially above, aligned with, or partially below the mitral annulus 1106 before dilation. In some embodiments, a pigtail catheter may be introduced into the heart to perform ventriculography for appropriate observation.

[0216] In some implementations, the position of the mitral plane and the height of any papillary muscles may be marked on the fluorescent monitoring device to indicate an exemplary target landing area. If necessary, the delivery system 10 may be deflected, rotated to reduce tension on the delivery system 10, and to reduce contact with the left ventricular wall, left atrial wall, and / or mitral annulus 1106.

[0217] Furthermore, the delivery system 10 can be positioned coaxially with the mitral annulus 1106, or at least as coaxially as possible, while still minimizing contact with the left ventricular wall, left atrial wall, and / or mitral annulus 1106 and reducing the tension on the delivery system. An echo probe can be placed to visualize the anterior mitral leaflet (AML), posterior mitral leaflet (PML) (leaflet 1108), mitral annulus 1106, and outflow tract. Fluorescence examination and echo imaging can confirm the prosthesis 1010 positioned at a specific depth and with coaxiality to the mitral annulus 1106.

[0218] Subsequently, the outer sheath assembly 22 can be retracted to expose and release the ventricular anchor 80. In some embodiments, once exposed, the outer sheath assembly 22 can be reversed to relieve tension on the outer sheath assembly 22. In some embodiments, reversing the direction can also be used to partially or completely capture the prosthesis 70.

[0219] The distal anchor 80 may be released in the left atrium 1078. Furthermore, the proximal anchor 82 (if included in the prosthesis 70) is not yet exposed. Additionally, the body of the prosthesis 70 has not yet undergone any expansion at this time. However, in some embodiments, one or more of the distal anchors 80 may be released in the left atrium 1078 (e.g., above the annulus), or substantially aligned with the mitral annulus 1106 (e.g., within the annulus), or directly below the mitral annulus 1106 (e.g., below the annulus). In some embodiments, all distal anchors 80 may be released together. In other embodiments, a subset of the distal anchors 80 may be released in a first position, while another subset of the distal anchors 80 may be released in a second position. For example, some of the distal anchors 80 may be released in the left atrium 1078, while some of the distal anchors 80 may be released substantially aligned with or directly below the mitral annulus 1106.

[0220] If the distal anchor 80 is released "directly below" the mitral annulus 1106, it can be released at a distance of 1 inch, 3 / 4 inch, 1 / 2 inch, 1 / 4 inch, 1 / 8 inch, 1 / 10 inch, or 1 / 20 inch below the mitral annulus 1106. In some embodiments, the distal anchor 80 can be released less than 1 inch, 3 / 4 inch, 1 / 2 inch, 1 / 4 inch, 1 / 8 inch, 1 / 10 inch, or 1 / 20 inch below the mitral annulus 1106. This allows the distal anchor 80 to bend through the chordae tendineae during release. This advantageously allows for slight retraction of the prosthesis 70 when making a sharp turn down toward the mitral valve. In some embodiments, this eliminates the need for a guidewire to assist across the mitral valve. In some embodiments, the guidewire can be withdrawn into the delivery system 10 before or after the release of the distal anchor 80.

[0221] In some implementations, the distal anchor 80 can be released immediately after crossing the diaphragm, and then the final trajectory of the delivery system 10 can be determined. Thus, the delivery system 10 can cross the diaphragm, release the ventricular anchor 80, establish a trajectory, and move into the left ventricle to capture the leaflet.

[0222] As discussed in detail above, after release from delivery system 10, the distal anchor 80 can be flipped from distal extension to proximal extension. This flip is approximately 180°. Therefore, in some embodiments, the distal anchor 80 can be flipped within the left atrium 1078 (e.g., above the annulus), approximately aligned with the mitral annulus 1106 (e.g., within the annulus), or directly below the mitral annulus 1106 (e.g., below the annulus). The proximal anchor 82 (if present) may remain within delivery system 10. In some embodiments, all distal anchors 80 can be flipped together. In other embodiments, a subset of the distal anchors 80 can be flipped in a first position, while another subset of the distal anchors 80 can be released in a second position. For example, some of the distal anchors 80 can be flipped within the left atrium 1078, while some of the distal anchors 80 can be flipped approximately aligned with or directly below the mitral annulus 1106.

[0223] In some embodiments, in the non-flipped position, the distal anchor 80 may be positioned aligned with or directly beneath the valve annulus 1106. In some embodiments, in the flipped position, the distal anchor 80 may be positioned aligned with or directly beneath the valve annulus 1106. In some embodiments, the distal portion of the prosthesis 70 may be positioned within or beneath the mitral valve annulus 1106, such as directly beneath the mitral valve annulus 1106, before flipping the distal portion. However, flipping the anchor may cause the distal portion of the prosthesis 70 / anchor 80 to move upwards, into the left atrium 1078, or to align with the mitral valve annulus 1106 without causing any other movement of the delivery system 10. Therefore, in some embodiments, the distal anchor 80 may begin to flip at the valve annulus 1106, but after flipping, it may be completely within the left atrium 1078. In some implementations, the distal anchor 80 may begin to flip under the annulus 1106, but after flipping, it is completely within the annulus 1106.

[0224] In some embodiments, after release and flipping, the distal anchor 80 may be proximal to the free edge of the mitral valve leaflet 1108 (e.g., toward the left atrium 1078). In some embodiments, after release and flipping, the distal anchor 80 may be aligned with the free edge of the mitral valve leaflet 1108 (e.g., toward the left atrium 078). In some embodiments, after release and flipping, the distal anchor 80 may be proximal to the free edge of the mitral valve annulus 1106 (e.g., toward the left atrium 1078). In some embodiments, after release and flipping, the distal anchor 80 may be aligned with the free edge of the mitral valve annulus 1106 (e.g., toward the left atrium 1078).

[0225] Therefore, in some embodiments, the distal anchor 80 may be released / flipped above the free edge of the chordae tendineae 1110 attached to the natural leaflet 1108. In some embodiments, the distal anchor 80 may be released / flipped above the free edge of some chordae tendineae 1110 attached to the natural leaflet 1108. In some embodiments, the distal anchor 80 may be released / flipped above the free edge of all chordae tendineae 1110 attached to the natural leaflet 1108. In some embodiments, the distal anchor 80 may be released / flipped above the mitral annulus 1106. In some embodiments, the distal anchor 80 may be released / flipped above the mitral leaflet 1108. In some embodiments, the distal anchor 80 may be released / flipped substantially aligned with the mitral annulus 1106. In some embodiments, the distal anchor 80 may be released / flipped substantially aligned with the mitral leaflet 1108. In some embodiments, the tip of the distal anchor 80 may be released / flipped substantially aligned with the mitral annulus 1106. In some embodiments, the distal anchor 80 may be released / flipped approximately aligned with the mitral leaflet 1108. In some embodiments, the distal anchor 80 may be released / flipped below the free edge where some of the chordae tendineae 1110 are attached to the natural leaflet 1108. In some embodiments, the distal anchor 80 may be released / flipped below the free edge where all the chordae tendineae 1110 are attached to the natural leaflet 1108. In some embodiments, the distal anchor 80 may be released / flipped below the mitral annulus 1106. In some embodiments, the distal anchor 1024 may be released / flipped below the mitral leaflet 1108.

[0226] Once the distal anchor 80 is released and flipped, the delivery system 10 can translate through the mitral annulus 1106 toward the left ventricle 1080, allowing the distal anchor 80 to enter the left ventricle 1080. In some embodiments, the distal anchor 80 may compress as it passes through the mitral annulus 1106. In some embodiments, the prosthesis 70 may compress as it passes through the mitral annulus 1106. In some embodiments, the prosthesis 70 does not compress as it passes through the mitral annulus 1106. The distal anchor 80 can be delivered anywhere between the leaflet 1108 and the papillary head in the left ventricle 1080.

[0227] In some embodiments, the distal anchor 80 is fully dilated before passing through the mitral annulus 1106. In some embodiments, the distal anchor 80 is partially dilated before passing through the mitral annulus 1106, and continued operation of the delivery system 10 may cause the distal anchor 80 to fully dilate within the left ventricle 1080.

[0228] When the distal anchor 80 enters the left ventricle 1080, the distal anchor 80 can pass through the chordae tendineae 1110 and move behind the mitral leaflet 1108, thereby capturing the leaflet 1108. In some embodiments, the distal anchor 80 and / or other portions of the prosthesis 1010 can push the chordae tendineae 1110 and / or the mitral leaflet 1108 laterally.

[0229] Therefore, after releasing the distal anchor 80, the delivery system 10 can be repositioned as needed so that the end of the remaining distal anchor 80 is at the same level as the free edge of the natural mitral leaflet 1108. If possible, the delivery system 10 can also be positioned coaxially with the mitral annulus 1106 while still minimizing contact with the left ventricular wall, left atrial wall, and / or annulus 1106.

[0230] In some embodiments, only the distal anchor 80 is released into the left atrium 1078 before the prosthesis 70 is moved to a position within or below the valve annulus. In some alternative embodiments, the distal end of the prosthesis 70 may be further expanded within the left atrium 1078. Thus, instead of flipping the distal anchor 80 and without any partial expansion of the body of the prosthesis 70, a portion of the prosthesis 70 can be exposed and allowed to expand within the left atrium 1078. This partially exposed prosthesis 1010 can then pass through the valve annulus 1106 into the left ventricle 1080. Additionally, the proximal anchor (if present) may be exposed. In some embodiments, the entire prosthesis 70 may expand within the left atrium 1078.

[0231] To facilitate passage through the annulus 1106, the delivery system 10 may include a leader element (not shown) that passes through the annulus 1106 before the prosthesis 70 passes through it. For example, the leader element may include an expandable member, such as an expandable balloon, which helps maintain the shape of the annulus 1106 or expand it. The leader element may have a conical or circular shape (e.g., conical, truncated conical, hemispherical) to facilitate positioning and expansion of the annulus 1106. In some embodiments, the delivery system 10 may include an engagement element (not shown) that applies force to the prosthesis 70 to force it through the annulus 1106. For example, the engagement element may include an expandable member, such as an expandable balloon, positioned within or above the prosthesis 70.

[0232] In some implementations, to facilitate passage through the annulus 1106, the user may reorient the prosthesis 70 before allowing it to pass through the annulus 1106. For example, the user may reorient the prosthesis 70 such that it passes through the annulus 1106 sideways.

[0233] However, if only the distal anchor 80 is flipped and no further dilation occurs, the prosthesis can partially dilate within the ventricle 1080. Therefore, when the prosthesis 70 is in the proper position, distal dilation can be permitted to capture the leaflet 1108. If distal dilation has already occurred, no further dilation may occur, or the distal portion may dilate further.

[0234] Furthermore, the PML and AML 1106 can be captured, for example, by adjusting the depth and angle of the prosthesis 70. If a larger prosthesis diameter is required to capture the leaflet 1106, the outer sheath assembly 22 can be retracted until the desired diameter of the prosthesis 70 is achieved. Capture of the leaflet 1106 can be confirmed by echo imaging. In some embodiments, the user can confirm that the prosthesis 70 remains at the appropriate depth and has not advanced into the left ventricle 1080. The position can be adjusted as needed.

[0235] In some embodiments, once the distal anchor 80 enters the left ventricle 1080, the system 10 can be pulled posteriorly (e.g., toward the left atrium 1078) to fully capture the leaflet 1108. In some embodiments, the system 10 does not need to be pulled posteriorly to capture the leaflet 1108. In some embodiments, systolic pressure can push the leaflet 1108 upward to be captured by the distal anchor 80. In some embodiments, systolic pressure can push the entire prosthesis 70 upward toward the mitral annulus 1106 after the leaflet 1108 has been captured and the prosthesis 70 has been fully or partially released. In some embodiments, the user can rotate the delivery system 10 and / or the prosthesis 70 before and / or simultaneously with pulling the delivery system 10 posteriorly. In some cases, this can advantageously engage a greater number of chordae tendineae.

[0236] The outer sheath assembly 22 can be further retracted to fully expand the prosthesis. Once the prosthesis 70 is fully exposed, the delivery system 10 can be manipulated to be coaxial and at a certain height relative to the mitral annulus 1106, such as by flexing, translating, or rotating it. If necessary, the prosthesis 70 can be repositioned to capture the free edge of the natural mitral leaflet 1108. Once the leaflet 1108 is confirmed to be fully engaged, the prosthesis 70 can be positioned perpendicular (or substantially perpendicular) to the plane of the mitral annulus.

[0237] Subsequently, the central shaft assembly 21 can be retracted. The orientation of the central shaft assembly 21 can then be reversed to relieve any tension on the delivery system 10.

[0238] The following discussion pertains to the proximal anchor 82, but some embodiments of the prosthesis 70 may not include them. In some embodiments, the proximal anchor 82 may not be released from the system 10 until the distal anchor 80 has captured the leaflet 1108. In some embodiments, the proximal anchor 82 may be released from the system 10 before the distal anchor 80 captures the leaflet 1108. In some embodiments, the proximal anchor 82 may be released when the distal anchor 80 is above or within the annulus, and the dilated prosthesis 70 (partially or fully dilated) may be translated through the mitral annulus 1106. In some embodiments, the proximal anchor 82 may be released when the distal anchor 80 is below the annulus, and the entire prosthesis 70 may be pulled upward into the left atrium 1078 such that the proximal anchor 82 is above the annulus before release. In some implementations, the proximal anchor 82 may be inside the ring before release, and the systolic pressure may push the prosthesis 70 toward the atrium so that the proximal anchor 82 is eventually above the ring.

[0239] Subsequently, leaflet capture and prosthesis 70 positioning, along with their relative vertical position relative to the mitral valve annulus plane, can be confirmed. In some embodiments, the nasal cone 28 can then be retracted until it is within the prosthesis 70. The central axis assembly 21 can be further retracted until the prosthesis 70 is released from the delivery system 10. Proper positioning of the prosthesis 70 can be confirmed using TEE and fluorescence imaging.

[0240] The delivery system 10 can then be positioned centrally within the prosthesis 70. The nasal cone 28 and the delivery system 10 can then be retracted into the left atrium 1078 and removed.

[0241] This intra-annular to above-annular release has many advantages. For example, it allows the distal anchor 82 to be properly aligned when contacting the chordae tendineae 1110. If the distal anchor 82 is released in the left ventricle 1080, this could lead to misalignment or damage to cardiac tissue such as the leaflets 1108 or the chordae tendineae 1110.

[0242] In an alternative delivery path, the delivery system 10 may be translated into the left ventricle 1080 before the prosthesis 70 is released. Thus, the distal end of the prosthesis 70, and consequently the distal anchor 82, may be partially or completely released and flipped within the left ventricle 1080. Therefore, in some embodiments, the anchor 70 may be released / flipped below the mitral annulus 1106, directly below the mitral annulus 1106, and / or below the free edge of the leaflet 1108. Furthermore, the anchor 70 may be released above the papillary head. The prosthesis 70 can then be properly positioned using a method similar to that discussed above, and the delivery system 10 removed to deliver the prosthesis 1010. Additionally, in some embodiments, the distal anchor 82 may be released without first dilating the prosthesis within the ventricle 1080.

[0243] Optional delivery system Figure 25 Examples of alternative delivery devices, systems, or components 10 are provided. This delivery system 10' may include any or all of the components discussed above with respect to delivery system 10. Furthermore, delivery system 10 may include any or all of the components discussed below with respect to delivery system 10'.

[0244] Similar to the above Figure 1 Implementation methods, such as Figure 25 As shown, the delivery system 10' may include a shaft assembly 12', which includes a proximal end 11' and a distal end 13', wherein a handle 14' is coupled to the proximal end of the assembly 12'. The shaft assembly 12' can be used to hold a prosthesis, as described elsewhere herein, to advance it through the vascular system to a treatment location. The delivery system 10' may further include a relatively rigid, one-piece (or integrated) sheath 51' surrounding the shaft assembly 12', which prevents undesired movement of the shaft assembly 12'. The shaft assembly 12' may include an implant retention region 16' at its distal end for this purpose (in... Figure 26A -B shows that, Figure 26A The prosthesis was shown as 70, while Figure 26B (The image shows the prosthesis 70 being removed). In some embodiments, the shaft assembly 12' can hold the expandable prosthesis in a compressed state at the implant holding region 16' for advancement of the prosthesis 70 in vivo. The shaft assembly 12' can then be used to allow controlled expansion of the prosthesis 70 at the treatment location. The implant holding region 16' is... Figure 26A -B is shown at the distal end of the delivery system, but it can also be located in other positions. In some embodiments, the prosthesis 70 can be rotated in the implant holding region 16', such as by rotating the inner shaft assembly 18' discussed herein.

[0245] like Figure 26AAs shown in the cross-sectional view of -B, the distal end of the delivery system 10' may include one or more sub-components, such as the outer shaft assembly 12', inner shaft assembly 18', track assembly 20', and nose cone assembly 31', which will be described in more detail below.

[0246] Specifically, embodiments of the disclosed delivery system utilize a manipulable track in the track assembly 20' to manipulate the distal end of the delivery system 10', thereby allowing proper positioning of the implant within the patient's body. Similar to the track assembly described above, the manipulable track can be, for example, a track shaft extending substantially from the handle through the delivery system 10' to the distal end. The user can manipulate the curvature of the distal end of the track, thereby bending the track in a specific direction. In some embodiments, the track may have more than one bend along its length, thus providing multiple bending directions. When the track bends, it can press against other components, causing them to bend as well, so that other components of the delivery system 10' can be configured to be manipulated together with the track, providing full operability of the distal end of the delivery system. Once the track is manipulated into a specific location within the patient's body, the prosthesis 70 can be advanced along the track and released into the body.

[0247] Starting with the outermost component, the delivery system may include an outer sheath assembly 22' that forms a radially outer cover or sheath to surround the implant retention region 16' and prevent radial expansion of the implant. Moving radially inward, an inner shaft assembly 18' may consist of an inner shaft whose distal end is attached to an inner retention member or inner retention ring 40' for axially retaining the prosthesis. The inner shaft assembly 18' may be located within the cavity of the outer sheath assembly 22'. Moving further inward, as described above and further below, a track assembly 20' may be configured for manipulation. The track assembly 20' may be located within the cavity of the inner shaft assembly 18'. Furthermore, the most radially inward component is the nasal cone assembly 31', which includes a nasal cone shaft 27' whose distal end is connected to a nasal cone 28'. The nasal cone assembly 31' may be located within the cavity of the track shaft assembly 20'. The nasal cone assembly 31' may include a cavity for guidewire passage.

[0248] The shaft assembly 12', and more specifically the nasal cone assembly 31', inner assembly 18', track assembly 20', and outer sheath assembly 22', can be configured together to position the implant within the implant retention area 16'. Figure 26AThe prosthesis 70 (shown in the diagram) is delivered to the treatment location. One or more sub-components can then be moved to allow the prosthesis 70 to be released at the treatment location. For example, one or more sub-components can be moved relative to one or more other sub-components. The handle 14' may include various control mechanisms that can be used to control the movement of the various sub-components, which will also be described in more detail below. In this way, the prosthesis 70 can be controllably loaded onto the delivery system 10' and then subsequently deployed in the body. Furthermore, the handle 14' can provide manipulation of the track assembly 20', thereby providing bending / deflection / manipulation to the distal end of the delivery system 10'.

[0249] As will be discussed below, the inner retaining member 40' and the outer sheath assembly 22' can cooperate to hold the prosthesis 70 in a compact configuration. The inner retaining member 40' in Figure 26A The image shows a strut 72 engaged at the proximal end 301 of the prosthesis 70. For example, a slot between radially extending teeth on the inner retainer 40' can receive and engage the strut 72, which can terminate at the proximal end of the prosthesis 70 with a mushroom-shaped protrusion 74. The outer sheath assembly 22' can be positioned above the inner retainer 40' such that the first end 301 of the prosthesis 70 is captured therebetween, thereby securely attaching the prosthesis 70 to the delivery system 10' between the outer sheath assembly 22' and the inner retainer 40'.

[0250] like Figure 26A As shown, the distal anchor 80 may be located in a delivery configuration where the distal anchor 80 is generally pointing distally (as shown, axially away from the body of the prosthesis frame and away from the handle of the delivery system). The distal anchor 80 may be constrained in this delivery configuration by the outer sheath assembly 22'. Thus, when the outer sheath 22' is retracted proximally, the distal anchor 80 may be flipped to a deployment configuration (e.g., generally pointing proximally). Figure 26A The proximal anchor 82 is also shown extending distally within the outer sheath assembly 22' in its delivery configuration. In other embodiments, the distal anchor 80 may be held generally proximal in the delivery configuration and compressed against the body of the prosthetic frame.

[0251] A delivery system 10' with a pre-installed prosthesis 70 can be provided to the user. In other embodiments, the prosthesis 70 may be loaded onto the delivery system shortly before use, such as by a physician or nurse.

[0252] As shown in Figure 26B, there may be no additional layer / axis / component between the inner retaining member 40' and the outer sheath assembly 22'. By eliminating this axis, the overall diameter of the delivery system 10' can be reduced.

[0253] However, in some embodiments, the outer retaining member (or ring) 42' may be incorporated into the delivery system 10', such as Figure 26CAs shown in the diagram. The outer retaining member 42' can be attached to the central shaft 43', which can be attached proximally to the handle 14'. When in the compressed position, the outer retaining member 42' can provide further stability to the prosthesis 70. The outer retaining member 42' can be positioned above the inner retaining member 40' such that the proximal end of the prosthesis 70 is captured therebetween, thereby securely attaching the prosthesis 70 to the delivery system 10.

[0254] The outer retaining member 42' may surround a portion of the prosthesis 70, particularly the first end 301', thereby preventing the prosthesis 70 from expanding. Furthermore, the central axis 43 may be translated proximally relative to the inner assembly 18' into the outer sheath assembly 22', thereby exposing the first end 301' of the prosthesis 70 held within the outer retaining member 42'. In this way, the outer retaining member 42' can be used to assist in securing the prosthesis 70 to or releasing it from the delivery system 10'. The outer retaining member 42' may have a cylindrical or elongated tubular shape and may sometimes be referred to as an outer retaining ring.

[0255] Delivery system components Figure 27-29 Another view of the delivery system 10' is shown, in which the different components are panned proximally and described in detail.

[0256] by Figure 27 Starting with the outermost component shown, the outer sheath assembly 22' may include an outer proximal shaft 102' directly attached to the handle 14' at its proximal end and an outer submersible tube 104' attached to its distal end. The capsule body 106' may then be attached substantially to the distal end of the outer submersible tube 104'. These components of the outer sheath assembly 22' may form cavities to allow other sub-assemblies to pass through.

[0257] The outer proximal shaft 102' can be a tube, and is preferably formed of plastic, but can also be a metal submersible tube or other materials. The outer submersible tube 104' can be a metal submersible tube, and in some embodiments, as discussed in detail below, the metal submersible tube may be cut or have slots. The outer submersible tube 104' may be covered or encapsulated with layers of ePTFE, PTFE or other materials such that the outer surface of the outer submersible tube 104' is substantially smooth.

[0258] The capsule body 106' can be a tube formed of plastic or metal material. In some embodiments, the capsule body 106' is formed of ePTFE or PTFE. In some embodiments, the capsule body 106' can be relatively thick to prevent tearing and help maintain the self-expanding implant in a compact configuration. In some embodiments, the material of the capsule body 106' is the same as the material of the coating on the outer submersible tube 104'. As shown, the diameter of the capsule body 106' can be larger than that of the outer submersible tube 104', although in some embodiments, the capsule body 106' can have a similar diameter to that of the submersible tube 104'. The capsule body 106' can be configured to hold the prosthesis 70 in a compressed position within the capsule body 106'.

[0259] The outer sheath assembly 22' is arranged to slide above the inner assembly 18', the track assembly 20', and the nose cone assembly 31'.

[0260] Moving radially inward, the next component is the inner shaft assembly 18'. Figure 28 Showing with Figure 27 A largely the same view, but with the outer sheath assembly 22' removed, thus exposing the inner shaft assembly 18'. It is thus noted that there are no other external retaining mechanisms or shafts, such as an outer retaining ring, between the inner shaft assembly 18' and the outer sheath assembly 22'.

[0261] The inner shaft assembly 18' may include an inner shaft 122' generally attached to the handle 14' at its proximal end, and an inner retaining ring 40' located at the distal end of the inner shaft 122'. The inner shaft 122' itself may consist of an inner proximal shaft 124' directly attached to the handle 14' at its proximal end and an inner sub-spindle 126' attached to the distal end of the inner proximal shaft 124'. Thus, the inner retaining ring 40' may be generally attached to the distal end of the inner sub-spindle 126'. These components of the inner shaft assembly 18' may form a cavity for the passage of other sub-assemblies.

[0262] Similar to other components, the inner proximal shaft 124' may include a tube, such as a hypodermic tube or a hypodermic tube (not shown). The tube may be made of a variety of different materials, including nitinol, stainless steel, and medical-grade plastics. The tube may be a single piece or multiple pieces joined together. Using a tube made of multiple pieces allows the tube to provide different properties, such as rigidity and flexibility, along different sections of the tube. The inner hypodermic tube 126' may be a metal hypodermic tube, which, in some embodiments, as discussed in detail below, may be cut or have slots. The tube 126' may be covered or encapsulated with layers of ePTFE, PTFE, or other materials such that the outer surface of the inner hypodermic tube 126' is generally smooth.

[0263] The inner retaining member 40' can be configured as a prosthesis retaining mechanism, as per [reference needed]. Figure 26AThe discussed prosthesis retention mechanism can be used to engage with the prosthesis. For example, the inner retention member 40' can be a ring and may include multiple slots configured to engage with the strut 72 on the prosthesis 70. The inner retention member 40' can also be considered part of the implant retention region 16' and may be located proximally in the implant retention region 16'. When the strut or other portion of the prosthesis 70 engages with the inner retention member 40', the capsule body may cover both the prosthesis and the inner retention member 40' to secure the prosthesis to the delivery system 10'. Thus, the prosthesis 70 can be clamped between the inner retention member 40' of the inner shaft assembly 18' and the capsule body 106' of the outer sheath assembly 22'.

[0264] The inner shaft assembly 18' is arranged to slide above the track assembly 20' and the nose cone assembly 31'.

[0265] Next, as Figure 29 As shown, radially inward from the inner shaft assembly 18' is the track assembly 20'. The track assembly may include a track shaft 132' (or track) attached generally at its proximal end to the handle 14'. The track shaft 132' may consist of a track proximal shaft 134' directly attached to the handle at its proximal end and a track hysteresis tube 136' attached to the distal end of the track proximal shaft 134'. The track hysteresis tube 136' may also include a non-invasive track tip at its distal end. These components of the track shaft assembly 20' may form cavities for other sub-assemblies to pass through.

[0266] One or more pull wires are attached to the inner surface of the track 136', which can be used to apply force to the track 136' and manipulate the track assembly 20'. The pull wires can extend distally from a knob in the handle 14' discussed below to the track 136'. In some embodiments, the pull wires can be attached at different longitudinal locations on the track 136', thereby providing multiple bending positions within the track 136' to allow for multidimensional manipulation.

[0267] In some embodiments, two distal pull wires 138' may extend to the distal section of the orbital thiocyanate tube 136', while two proximal pull wires 140' may extend to the proximal section of the orbital thiocyanate tube 136'. However, other numbers of pull wires may be used, and there is no limitation on the specific number of pull wires. For example, a single pull wire may extend to the distal position, and a single pull wire may extend to the proximal position. In some embodiments, an annular structure (referred to as a pull wire connector) attached inside the orbital thiocyanate tube 136' may be used as the attachment point for the pull wires. In some embodiments, the orbital assembly 20' may include distal pull wire connectors and proximal pull wire connectors. In some embodiments, the pull wires may be directly connected to the inner surface of the orbital thiocyanate tube 136'.

[0268] The distal pull wire 138' may be connected approximately at the distal end of the orbital thiocyanate tube 136' (alone or via a connector). The proximal pull wire 140' may be connected at approximately one-quarter, one-third, or one-half of the length of the orbital thiocyanate tube 136' from the proximal end (alone or via a connector). In some embodiments, the distal pull wire 138' may pass through a small-diameter pull wire cavity attached to the interior of the orbital thiocyanate tube 136'. In some embodiments, the distal pull wire 138' may pass through a small-diameter coil and / or thiocyanate tube to provide independent actuation. The small-diameter coil and / or thiocyanate tube may be attached to the interior of the orbital thiocyanate tube 136', which allows for independent actuation and flexibility in the shaft. This prevents the wire 138' from pulling the orbital thiocyanate tube 136' near the distal connection. In some embodiments, these cavities may be attached to the outer surface of the nasal cone shaft 31', located distal to the position where the proximal traction wire 140' is attached to the orbital thallium tube 136'.

[0269] For the paired proximal traction filaments 140', the filaments may be spaced approximately 180° apart to allow manipulation in both directions. Similarly, for the paired distal traction filaments 138', the filaments may be spaced approximately 180° apart to allow manipulation in both directions. In some embodiments, the paired distal traction filaments 138' and the paired proximal traction filaments 140' may be spaced approximately 90° apart. In some embodiments, the paired distal traction filaments 138' and the paired proximal traction filaments 140' may be spaced approximately 0° apart. However, other positions of the traction filaments may also be used, and the specific positions of the traction filaments are not limited.

[0270] The track assembly 20' is arranged so that it can slide above the nose cone assembly 31'.

[0271] Moving further inward from the track assembly is the nose cone assembly 31', also as... Figure 29 As shown in the diagram. This can be a nasal cone axis 27', and in some embodiments, a nasal cone 28' may be present at its distal end. The nasal cone 28' may be made of polyurethane for non-invasive access and to minimize damage to the venous vascular system. The nasal cone 28' may also be radiopaque to provide visibility under fluorescence examination.

[0272] The nasal cone shaft 27' may include a cavity, which is sized and configured to slidably receive a guidewire, allowing the delivery system 10' to be advanced over the guidewire through the vascular system. However, embodiments of the system 10' discussed herein may be implemented without a guidewire, and therefore the nasal cone shaft 27' may be solid. The nasal cone shaft 27' may be connected from the nasal cone 28' to a handle, or may be formed from different parts such as other components. Furthermore, the nasal cone shaft 27' may be formed from different materials, such as plastic or metal, similar to those described in detail above.

[0273] In some embodiments, one or more spacer sleeves (not shown) may be used between different components of the delivery system 10'. For example, a first spacer sleeve may be concentrically located between the inner shaft assembly 18' and the track assembly 20', generally between the inner submersible tube 126' and the track submersible tube 136'. A second spacer sleeve may be concentrically located between the track assembly 20' and the nose cone assembly 31', generally longitudinally within the track submersible tube 136'. The spacer sleeves may be made of a polymeric material (such as braided Pebax®) and may be lined with, for example, PTFE on the inner diameter, but there are no limitations on the specific material. The spacer sleeves can advantageously reduce friction between the maneuverable track assembly 20' and its surrounding components. Thus, the spacer sleeves can act as a buffer between the track assembly 20' and the inner assembly 18' / nose cone assembly 30'. Furthermore, the spacer sleeves can occupy any radius of clearance between the components, thereby preventing the components from being compressed or bent during manipulation.

[0274] The spacer sleeve can be mechanically accommodated by other cavities and components, and thus non-physically attached to any other component, allowing the spacer sleeve to "float" in the region. This floating aspect of the spacer sleeve allows it to move to the desired location during deflection and provides a supporting and / or lubricating bearing surface / multiple bearing surfaces. Therefore, the floating aspect allows the delivery system 10' to maintain flexural force. However, in some embodiments, the spacer sleeve may be attached to other components.

[0275] Hypoglow tube construction As discussed above, the outer sheath assembly 22', inner assembly 18', and track assembly 20' may respectively comprise an outer submersible tube 104', an inner submersible tube 126', and a track submersible tube 136'. Each of these submersible tubes may be laser-cut to include multiple slots, thereby creating a curved path for the delivery system. Although different slotted assemblies are discussed below, it should be understood that any of the three types of submersible tubes may have any of the slotted configurations discussed below. Figure 30-32 Different hysteresis tubes are shown in isolated form.

[0276] Figure 30 The submersible tube 104' (distal end facing right) shown may include a plurality of slots 103' transverse to its cavity along most of the length of the submersible tube 104'. Each of the slots may extend almost completely around the circumference of the submersible tube 104', thereby forming a single ridge 105' of material extending between the proximal and distal ends of the submersible tube 104'. In some embodiments, the submersible tube 104' may include more than one ridge. As shown, the slots may extend generally from the proximal end of the submersible tube 104' to the distal end of the submersible tube 104', thereby allowing the submersible tube 104' to bend more easily with the track assembly 20'.

[0277] As shown, the ridge 105' can rotate circumferentially as it advances from the proximal end to the distal end of the subsurface wave tube 104'. For example, the distal end of the ridge 105' can be offset from the proximal end by approximately 30°, 45°, 90°, 135°, or 180°. In some embodiments, approximately half the length of the ridge 105' from the proximal end to the subsurface wave tube 104' remains in the same circumferential position. At this point, the ridge 105' can begin to rotate circumferentially around the subsurface wave tube 104'. The curvature of the ridge helps guide the subsurface wave tube 105 during manipulation of the track assembly 20'. When entering the heart and being guided toward the mitral valve, the ridge 105' generally follows the typical curvature formed by the track assembly 20', thereby mitigating some of the forces that might occur if the ridge 105' were straight. However, in some embodiments, the ridge 105' of the subsurface wave tube 104' can be straight, and the specific configuration of the ridge is not limited.

[0278] Move radially inward, in Figure 31 In this embodiment, the inner waveguide 126' also includes a plurality of slots 1402' (distally facing to the right). However, unlike the outer waveguide 104', in some embodiments, the inner waveguide 126' does not include slots along most of its length 1400', but in other embodiments, the inner waveguide 126' may include slots. This allows the inner waveguide 126' to be more rigid, as it will experience significant compression, and the absence of a helical ridge prevents coiling. Furthermore, as described below, this allows the inner assembly 18' to guide the other assemblies to extend in a straight line when advanced above the track assembly 20'.

[0279] The inner subsea tube 126' may include slots that extend transversely to its cavity axis for approximately 1 / 4, 1 / 3, or 1 / 2 of its distal length, starting generally from the distal end. In some embodiments, unlike the single ridge of the outer subsea tube 104', each circumferential location may have two slots with a span of less than 180°, thus forming two ridges 127' in the inner subsea tube. These ridges 127' may be spaced approximately 180° apart, but in some embodiments different angles may be used depending on the desired curvature. However, in some embodiments, a single ridge or more than two ridges may be used. Additional ridges may provide additional stiffness to the inner assembly 18'.

[0280] In some embodiments, the inner throttle tube 126' may comprise a single slot pattern forming the double ridges discussed above. In some embodiments, the inner throttle tube 126' may comprise two different slot patterns. For example, at the farthest end, the slot may be configured with only one bending direction (e.g., only on the X-axis), making this section both rigid and strong, yet less flexible. However, the slots in the proximal sections may be configured to include multiple bending axes (e.g., the X-axis and the Y-axis), giving the inner throttle tube 126' greater flexibility for maneuvering. In some embodiments, the configuration of the inner throttle tube 126' generates a force desired for straight extension (e.g., without bending). Therefore, when the inner throttle tube 126' is advanced over the orbital throttle tube 136', it will achieve a straight configuration.

[0281] Next, move radially inward again. Figure 32 An embodiment of the orbital wave tube 136' is shown (far end facing right). The orbital wave tube 136' may also include multiple transverse slots. The orbital wave tube can be roughly divided into several distinct sections. At the closest end is the uncut (or ungrooved) wave tube section 131'. This may occupy approximately one-quarter to one-third of the orbital wave tube 136'. Moving further distally, the next section is the near-grooved wave tube section 133'. This section includes multiple transverse slots cut into the orbital wave tube. Generally, two slots are cut around each circumferential location, forming almost half a circumference. Thus, two main trunks extending along the length of the wave tube 136' are formed between these slots. This is the section that can be guided by the near-side drawstring 140'. Moving further distally, there is the location 137' where the near-side drawstring 140' connects, thus avoiding grooving. This section is exactly at the far end of the near-side grooved section.

[0282] Along the distal direction, behind the proximal filament connection area is the distally slotted submersible tube section 135'. This section is similar to the proximal slotted submersible tube section 133', but has significantly more slots cut to equal lengths. Therefore, the distally slotted submersible tube section 135' provides easier bending than the proximal slotted submersible tube section 133'. In some embodiments, the proximal slotted section 133' can be configured to undergo a bend of approximately 90 degrees with a half-inch radius, while the distally slotted section 135' can be bent at approximately 180 degrees within half an inch. Furthermore, as... Figure 32 As shown, the ridge of the distally slotted submersible segment 135' is offset from the ridge of the proximally slotted submersible segment 133'. Therefore, the two segments will achieve different curvature patterns, allowing for three-dimensional manipulation of the track assembly 20'. In some embodiments, while the specific offset is not limited, the ridge may be offset by 30 degrees, 45 degrees, or 90 degrees.

[0283] At the far end of the slotted subwoofer section 135' is the far-side traction wire connection area 139', followed by the non-slotted section of the track subwoofer 136'.

[0284] handle The handle 14' is located at the proximal end of the delivery system 10', and as... Figure 33 As shown in the diagram. It may include multiple actuators (such as rotatable knobs) that can manipulate different components of the delivery system. The operation of the handle 10' is described with reference to the delivery of a replacement mitral valve prosthesis, but the handle 10' and delivery system 10' can also be used to deliver other devices.

[0285] The handle 14' generally comprises two housings—a track housing 202' and a delivery housing 204', the track housing 204' being arranged circumferentially around the delivery housing 204'. The inner surface of the track housing 202' may include a screwable section configured to engage with the outer surface of the delivery housing 204'. Therefore, as described in detail below, the delivery housing 204' is configured to slide (e.g., screw) within the track housing 202'. The track housing 202' generally extends about half the length of the delivery housing 204', thus extending to the exterior of the track housing 202' both proximally and distally.

[0286] The track housing 202' may include two rotatable knobs—a distal traction wire knob 206' and a proximal traction wire knob 208'. However, the number of rotatable knobs on the track housing 202' may vary depending on the number of traction wires used. Rotation of the distal traction wire knob 206 provides a proximal force, thereby providing axial tension on the distal traction wire 138' and bending the distal slotted section 135' of the track thiopanel 136'. The distal traction wire knob 206' can rotate in either direction, thus allowing bending in either direction. Rotation of the proximal traction wire knob 208' provides a proximal force on the proximal traction wire 140', and thus provides axial tension, thereby bending the proximal slotted section 133' of the track thiopanel 136'. The proximal traction wire knob 208' can rotate in either direction, thus allowing bending in either direction. Therefore, when both knobs are actuated, two bends exist in the orbital tube 136', allowing three-dimensional manipulation of the orbital axis 132', thereby enabling three-dimensional manipulation of the distal end of the delivery system 10'. Furthermore, the proximal end of the orbital axis 132' is connected to the inner surface of the orbital housing 202'.

[0287] The bending of the track axis 132' can be used to position the system, particularly the distal end, at the desired patient location, such as at the natural mitral valve. In some embodiments, rotation of the traction wire knobs 206' / 208' can help manipulate the distal end of the delivery system 10' through the septum and left atrium and into the left ventricle, so that the prosthesis 70 is positioned at the natural mitral valve.

[0288] The inner shaft assembly 19', outer sheath assembly 22', and nose cone shaft assembly 30' are moved to the delivery housing 204', where the proximal ends can be connected to the inner surface of the delivery housing 204' of the handle 14'. Therefore, they are axially movable relative to the track assembly 20' and track housing 202'.

[0289] A rotatable outer sheath knob 210' may be located on the distal end of the delivery housing 204', distal to the track housing 202'. Rotation of the outer sheath knob 210' will pull the outer sheath assembly 22' proximally in the axial direction, thereby pulling the capsule body 106' away from the implant 70 and releasing the implant 70. The distal end 303' of the implant 70 may be released first, followed by the proximal end 301' of the implant 70 as the outer sheath knob 210' continues to rotate.

[0290] A rotatable depth knob 212' is located at the proximal end of the delivery housing 204', and therefore proximal to the track housing 202'. When the depth knob 212' is rotated, the entire delivery housing 204' moves distally or proximally relative to the track housing 202', which remains in the same position. Thus, at the distal end of the delivery system 10', the inner shaft assembly 18', the outer sheath assembly 22', and the nasal cone shaft assembly 30' move proximally or distally relative to the track assembly 20'. Therefore, the track shaft 132' can be aligned in a specific direction, and other components can be moved distally or proximally relative to the track shaft 132' for final positioning. The component can be advanced approximately 1, 2, 3, 5, 6, 7, 8, 9, or 10 cm along the track shaft 132'. The component can then be advanced more than approximately 1, 2, 3, 5, 6, 7, 8, 9, or 10 cm along the track shaft 132'. The capsule body 106' can then be withdrawn, thereby releasing the implant 70. Then, by rotating the depth knob 212' in the opposite direction, the components other than the track assembly 20' can be retracted back above the track axis 132'.

[0291] delivery method Figures 34-36 An example of the release mechanism of the delivery system 10' is shown. During the initial insertion of the prosthesis 70 and the delivery system 10' into the body, the prosthesis 70 may be located within the system 10', similar to... Figure 26A As shown in the diagram, the distal end 303' of the prosthesis 70, and specifically the distal anchor 80, is restrained within the capsule body 106' of the outer sheath assembly 22', thereby preventing expansion of the prosthesis 70. Similar to... Figure 26A As shown, the distal anchor 80 can extend distally when positioned within the capsule body. The proximal end 301' of the prosthesis 70 is constrained within the capsule body 106' and a portion of the inner retaining member 40', and is therefore generally constrained between the capsule body 106' and the inner retaining member 40'.

[0292] By using the manipulation mechanism or other techniques discussed herein, the system 10' can first be positioned in a specific location within the patient's body, such as at the natural mitral valve.

[0293] Once the prosthesis 70 is loaded into the delivery system 10', the user can insert a guidewire into the patient's body to the desired location. The guidewire passes through the cavity of the nasal cone assembly 31', so the delivery system 10' is generally advanced through the patient's body following the guidewire. The delivery system 10' can be advanced by the user manually moving the handle 14' in the axial direction. In some embodiments, the delivery system 10' can be placed on a support while the handle 14' is being operated.

[0294] Once the suture is roughly inside the heart, the user can begin operating the track assembly 20' using the distal traction wire knob 206' and / or the proximal traction wire knob 208'. By turning either knob, the user can provide flexion / bending (distal or proximal) to the track assembly 20', thereby bending the distal end of the delivery system 10' into the desired configuration. As discussed above, the user can provide multiple bends in the track assembly 20' to guide the mitral valve delivery system 10' towards the mitral valve.

[0295] The user can also rotate and / or move the handle 14' itself within the support to further adjust the distal end of the delivery system 10'. The user can continuously rotate the proximal traction wire knob 208' and / or the distal traction wire knob 206', as well as move the handle 14' itself, to orient the delivery system 10', thereby releasing the prosthesis 70' into the body.

[0296] Next, the user can rotate the depth knob 212'. As discussed, rotation of this knob 212' advances the inner shaft assembly 18', the outer sheath assembly 22', and the nose cone assembly 31' above / through the track assembly 20'. Due to, for example, the rigidity of the inner shaft assembly 18', these assemblies travel straight forward in a direction aligned with the track assembly 20'.

[0297] Once in the release position, the user can rotate the outer sheath knob 210', which moves the outer sheath assembly 22' toward the handle 14' and translates it in a proximal direction (and thus translates the capsule body 106'), as... Figure 34As shown in the diagram. By doing so, the distal end 303' of the prosthesis 70 is exposed within the body, thereby allowing the initiation of dilation. At this point, the distal anchor 80 can be flipped proximally, and the distal end 303' begins to dilate radially outward. For example, if the system 10' has been delivered to the natural mitral valve location via a transseptal path, the nasal cone is positioned in the left ventricle, such that the prosthesis 70 is substantially perpendicular to the plane of the mitral annulus. The distal anchor 80 dilates radially outward within the left ventricle. The distal anchor 80 may be located above the papillary head, but below the mitral annulus and mitral leaflets. In some embodiments, the distal anchor 80 may contact the chordae tendineae in the left ventricle and / or extend between the chordae tendineae, and contact the leaflets as the distal anchor 80 dilates radially. In some embodiments, the distal anchor 80 may not contact the chordae tendineae and / or not extend between the chordae tendineae or contact the leaflets. Depending on the location of the prosthesis 70, the distal end of the distal anchor 80 may be located at or below the free edge where the chordae tendineae connect to the natural leaflet.

[0298] Next reference Figure 35 In this step, the outer sheath assembly 22' can be moved further relatively away from the nasal cone 28' to further expose the prosthesis 70. As shown in the example embodiment, the distal end 303' of the prosthesis 70 expands outward. It should be noted that during this step, the proximal end 301' of the prosthesis 70 may still be covered by the capsule body 106', such that the proximal end 301' remains in a radially compressed state. At this time, the system 10' can be retracted proximally, such that the distal anchor 80 captures and engages the leaflet of the mitral valve, or it can be moved proximally to reposition the prosthesis 70. Furthermore, the system 10' can be twisted, which can cause the distal anchor 80 to apply tension to the chordae tendineae, at least some of which can extend between the chordae tendineae by tension. However, in some embodiments, the distal anchor 80 may not apply tension to the chordae tendineae. In some implementations, after the outer sheath assembly 22' is withdrawn, the distal anchor 80 can capture the natural leaflet and may be positioned between the tendineae without causing any further movement of the system 10'. Therefore, during this step, system 10' can be moved proximally or distally to allow the distal or ventricular anchor 80 to properly capture the natural mitral valve leaflet. Specifically, the distal end of the ventricular anchor 80 can be moved proximally to engage the ventricular side of the natural valve annulus, positioning the natural leaflet between the anchor 80 and the body of the prosthesis 70. When the prosthesis 70 is in its final position, although the distal anchor 80 may be located between at least some of the chordae tendineae, there may or may not be tension on the chordae tendineae.

[0299] If an outer retaining ring 42' is used, the distal end 303 of the prosthesis 70 will remain within the outer retaining ring 42' after the capsule body 106' retracts. The outer retaining ring 42' can then retract proximally to release the distal end 303 of the prosthesis 70.

[0300] like Figure 36 As shown, once the distal end 303 of the prosthesis 70 is fully dilated (or as fully dilated as possible at this point), the capsule body 106' can be moved further proximally to expose the internal retention member 40', thereby initiating dilation of the proximal end 301 of the prosthesis 70. For example, in a mitral valve replacement procedure, the proximal end 301 of the prosthesis 70 can be dilated in the left atrium after the distal or ventricular anchor 80 has been positioned between at least some of the chordae tendineae and / or engaged with the natural mitral valve annulus.

[0301] The capsule body 106 may continue to move proximally, allowing the proximal end 301 of the prosthesis 70 to expand radially to its fully expanded configuration. After the prosthesis 70 has been expanded and released, the nasal cone 28' may be withdrawn through the center of the expanded prosthesis 70 and into the outer sheath assembly 22'. The system 10' may then be removed from the patient.

[0302] Other valve prostheses Figure 37-40 Examples of alternative implementations of prostheses that can be used with the disclosed delivery system 10 and methods discussed herein are provided. Figure 37 An alternative implementation of the prosthesis is illustrated. Figure 37 The reference number is the same as the one mentioned above. Figure 3A The same applies to the discussion, and may be related to U.S. Patent Publication No. 2018 / 0055629 (the entire contents of which are incorporated herein by reference). Figure 39-4 1. Find further discussion. Figure 38A-40 Another alternative implementation of the prosthesis is illustrated, and can be found with reference to U.S. Patent Publication No. 2018 / 0055629. Figure 33-35 Further discussion is found, differing in that the outer frame anchoring feature is described in this publication. These embodiments may have similar or identical features to the prosthesis discussed herein. In some embodiments, the prosthesis may be a single-frame prosthesis. In some embodiments, the prosthesis may be a double-frame prosthesis. In some embodiments used as mitral valve replacements, the prosthesis includes distal or ventricular anchors similar to the anchors described above (see, for example, anchoring member 1524 described below), but does not include proximal or atrial anchors.

[0303] Next reference Figure 38A An example is provided of an embodiment of a prosthesis 1500 in an expanded configuration. The prosthesis 1500 may include an inner frame 1520, an outer frame 1540, a valve body 1560, and one or more skirts, such as an outer skirt 1580 and an inner skirt 1590.

[0304] Referring first to the inner frame 1520, the inner frame 1520 may include an inner frame body 1522 and an inner frame anchoring member 1524. The inner frame body 1522 may have an upper region 1522a, a middle region 1522b, and a lower region 1522c. As shown, the inner frame body 1522 may have a generally spherical shape, such that the diameters of the upper region 1522a and the lower region 1522c are smaller than the diameter of the middle region 1522b. The diameter of the upper region 1522a may be smaller than the diameter of the lower region 1522c. This advantageously allows for the use of a smaller valve body 1560 within the inner frame 1520, while allowing the inner frame body 1522 to have a larger diameter near the connection between the inner frame body 1522 and the inner frame anchoring member 1524. This larger diameter reduces the radial distance between the connection and the tip or end of the inner frame anchoring member 1524. This can beneficially enhance the fatigue resistance of the inner frame anchor member 1524 by reducing the length of the cantilever.

[0305] Although the inner frame body 1522 of the example is spherical, it should be understood that the diameters of the upper region 1522a, the middle region 1522b, and / or the lower region 1522c may be the same, such that the inner frame body 1522 is generally cylindrical along one or more regions. Furthermore, although the example embodiment includes a lower region 1522a with a diameter greater than that of the upper region 1522c, it should be understood that the diameters of the upper region 1522a and the lower region 1522c may be the same, or the diameter of the upper region 1522a may be greater than that of the lower region 1522c. Moreover, although the inner frame body 1522 has been described and exemplified as cylindrical or having a circular cross-section, it should be understood that all or part of the inner frame body 1522 may have a non-circular cross-section, such as, but not limited to, D-shaped, elliptical, or other oval cross-sectional shapes.

[0306] Next reference Figure 38A The outer frame 1540 in the example can be attached to the inner frame 1520 using any suitable fasteners and / or other techniques. Although the outer frame 1540 is illustrated as a separate component from the inner frame 1520, it should be understood that frames 1520 and 1540 can be formed integrally or as a single unit.

[0307] As shown in the example embodiment, the outer frame 1540 may include an outer frame body 1542. The outer frame body 1542 may have an upper region 1542a, a middle region 1542b, and a lower region 1542c. When in a configuration such as full expansion, the outer frame body 1542 may have an enlarged shape, wherein the middle region 1542b and the lower region 1542c are larger than the upper region 1542a. The enlarged shape of the outer frame body 1542 may advantageously allow the outer frame body 1542 to engage with the natural valve annulus, natural valve leaflet, or other tissue of the body cavity, while spaced at its upper end from the heart or blood vessel wall.

[0308] The upper region 1542a of the outer frame body 1542 may include a first segment 1546a and a second segment 1546b. The first segment 1546a may be sized and / or shaped to substantially match the size and / or shape of the inner frame 1520. For example, the first segment 1546a may have a curvature that matches the curvature of the upper region 1522a of the inner frame body 1522. The second segment 1546b may extend radially outward away from the inner frame 1520. As shown in the example embodiment, the transition between the first segment 1546a and the second segment 1546b may include a bend such that the second segment 1546b extends radially outward at a larger angle relative to the longitudinal axis.

[0309] The middle region 1542b of the outer frame body 1542 extends substantially downward from the outwardly extending segment 1546b of the upper region 1542a. As shown, the middle region 1542b may have a substantially constant diameter from the upper end to the lower end, such that the middle region 1542b forms a substantially cylindrical shape. The lower region 1542c of the outer frame body 1542 extends substantially downward from the lower end of the middle region 1542b. As shown, the lower region 1542c of the outer frame body 1542 may have a substantially constant diameter from the upper end to the lower end, such that the lower region 1542c forms a substantially cylindrical shape. As shown, the diameters of the middle region 1542b and the lower region 1542c are substantially equal, such that the middle region 1542b and the lower region 1542c together form a substantially cylindrical shape.

[0310] Although the intermediate region 1542b and the lower region 1542c are described as cylindrical, it should be understood that the diameters of the upper end, the lower end, and / or the portion in between may be different. For example, the diameter of the portion between the upper and lower ends may be larger than that of the upper and lower ends, such that the intermediate region 1542b and / or the lower region 1542c form a generally spherical shape. In some embodiments, the diameter of the lower end may be larger than that of the upper end. In other embodiments, the diameter of the upper end may be larger than that of the lower end. Furthermore, although the outer frame body 1542 has been described and exemplified as cylindrical or having a circular cross-section, it should be understood that all or part of the outer frame body 1542 may have a non-circular cross-section, such as, but not limited to, D-shaped, elliptical, or other oval cross-sectional shapes.

[0311] The outer frame 1540, such as the outer frame body 1542, can be used to attach or secure the prosthesis 1500 to a natural valve, such as a natural mitral valve. For example, the intermediate region 1542b of the outer frame body 1542 and / or the outer anchoring member 1544 can be positioned to contact or engage the natural valve annulus, tissue beyond the natural valve annulus, natural leaflets, and / or other tissue located at or around the implantation site during one or more phases of the cardiac cycle, such as systole and / or diastole. As another example, the outer frame body 1542 can be sized and positioned relative to the inner frame anchoring member 1524 such that tissue within the body cavity is positioned between the outer frame body 1542 and the inner frame anchoring member 1524, such as natural valve leaflets and / or natural valve annulus, which can be engaged or compressed to further secure the prosthesis 1500 to the tissue.

[0312] Continue to refer to Figure 38A In the example of the prosthesis 1500, the valve body 1560 is attached to the inner frame 1520 inside the inner frame body 1522. The valve body 1560 acts as a one-way valve to allow blood to flow through the valve body 1560 in a first direction and to inhibit blood from flowing through the valve body 1560 in a second direction.

[0313] The valve body 1560 may include a plurality of leaflets 1562 joined at the commissure, such as three leaflets 1562. The valve body 1560 may include one or more intermediate members 1564. The intermediate member 1564 may be positioned between a portion or all of the leaflet 1562 and the inner frame 1520 such that at least a portion of the leaflet 1562 is coupled to the frame 1520 via the intermediate member 1564. In this manner, a portion or all of the portion of the leaflet 1562 at the commissure and / or the arcuate edge of the leaflet 1562 is not directly coupled or attached to the inner frame 1520, but is indirectly coupled to or "floats" within the inner frame 1520. For example, a portion or all of the portion of the leaflet 1562 near the commissure and / or arcuate edge of the leaflet 1562 may be radially inwardly spaced from the inner surface of the inner frame 1520. By using one or more intermediate components 1564, the valve leaflet 1562 can be attached to a non-cylindrical frame 1520 and / or frame 1520 with a diameter greater than that of the valve leaflet 1562.

[0314] Next reference Figure 38A The outer skirt 1580, as shown in the example, may be attached to the inner frame 1520 and / or the outer frame 1540. As illustrated, the outer skirt 1580 may be positioned around and secured to a portion or all of the exterior of the outer frame 1540. The outer skirt 1580 may also be secured to a portion of the valve body 1560, such as, but not limited to, the intermediate member 1564. For example, the skirt 1580 may be attached to the inflow region of the intermediate member 1564. As illustrated, the outer skirt 1580 may follow the contour of the outer frame 1540; however, it should be understood that at least a portion of the skirt 1580 may be spaced apart from at least a portion of both the inner frame 1520 and the outer frame 1540.

[0315] Next reference Figure 38A The example shows an inner skirt 1590, which may be attached to the valve body 1560 and the outer skirt 1580. As shown, a first end of the inner skirt 1590 may be coupled to the valve body 1560 along a portion of the valve body 1560 near the inner frame 1520. A second end of the inner skirt 1590 may be attached to a lower region of the outer skirt 1580. This creates a smooth surface under each leaflet. This can beneficially enhance hemodynamics by allowing blood to circulate more freely and reducing stagnant areas. In some embodiments, the inner skirt 1590 may advantageously reduce contact between the outer frame body 1542 and the inner frame body 1522.

[0316] Although the prosthesis 1500 has been described as including an inner frame 1520, an outer frame 1540, a valve body 1560, and skirts 1580 and 1590, it should be understood that the prosthesis 1500 does not need to include all components. For example, in some embodiments, the prosthesis 1500 may include the inner frame 1520, the outer frame 1540, and the valve body 1560, while omitting the skirt 1580. Furthermore, although the components of the prosthesis 1500 have been described and exemplified as separate components, it should be understood that one or more components of the prosthesis 1500 may be formed integrally or monolithically. For example, in some embodiments, the inner frame 1520 and the outer frame 1540 may be integrally or monolithically formed as a single component.

[0317] Figure 38B Example Figure 38A An alternative implementation involves a modification to the design of the skirt (or fabric) 1580 / 1590. As shown, the skirt 1580 / 1590 may contact both the inner frame 1520 and the outer frame 1540. The skirt 1580 / 1590 may begin inside the outer frame 1540, transition to the outside of the outer frame 1540, then attach to the bottom of the outside of the inner frame 1520, and then travel upwards along the outside of the inner frame 1520. By closing the skirt 1580 / 1590, clot formation / embolism is avoided / reduced.

[0318] Next reference Figures 39-40 An example is provided of an embodiment of a prosthesis 1600 in an expanded configuration. This prosthesis 1600 may be constructed similarly to the prosthesis 1500 described above. The prosthesis 1600 may include an inner frame 1620, an outer frame 1640, a valve body 1660, and one or more skirts, such as an outer skirt 1680 and an inner skirt 1690.

[0319] First refer to Figures 39-40 The outer frame 1640 in the example can be attached to the inner frame 1620 using any known fasteners and / or techniques. Although the outer frame 1640 is illustrated as a separate component from the inner frame 1620, it should be understood that frames 1620 and 1640 can be formed integrally or as a single unit.

[0320] As shown in the example embodiment, the outer frame 1640 may include an outer frame body 1642. The outer frame body 1642 may have an upper region 1642a, a middle region 1642b, and a lower region 1642c. At least a portion of the upper region 1642a of the outer frame body 1642 may be sized and / or shaped to substantially match the size and / or shape of the upper region 1622a of the inner frame 1620. As shown in the example embodiment, the upper region 1642a of the outer frame body 1642 may include one or more struts that substantially match the size and / or shape of the struts of the inner frame 1620. This can locally reinforce a portion of the prosthesis 1600 by effectively increasing the wall thickness of the combined struts.

[0321] When in an expanded configuration (such as a fully expanded configuration), the outer frame body 1642 may have the features described above. Figure 38A The outer frame body 1542 is described as having a similar shape. As shown, the diameters of the middle region 1642b and the lower region 1642c may be larger than the diameter of the upper region 1642a. The upper region 1642a of the outer frame body 1642 may have a diameter that decreases from the lower end to the upper end, such that the upper region 1642a is radially inwardly inclined or curved toward the longitudinal axis of the prosthesis 1600. Although the outer frame body 1642 has been described and exemplified as cylindrical or having a circular cross-section, it should be understood that all or part of the outer frame body 1642 may have a non-circular cross-section, such as, but not limited to, D-shaped, elliptical, or other oval cross-sectional shapes.

[0322] Continue to refer to Figure 39 The outer frame 1600 in the example, the outer frame body 1642 may include multiple pillars, wherein at least some of the pillars form cells 1646a-c. Any number of pillar configurations can be used, such as the ring of undulating pillars shown, which form ellipses, ovals, rounded polygons and teardrop shapes, as well as V-shapes, rhombuses, curves and various other shapes.

[0323] The upper row of unit 1646a may have an irregular octagonal shape, such as a heart shape. This additional space can advantageously allow the outer frame 1640 to maintain a smaller profile when folded. Unit 1646a may be formed by an assembly of struts. As shown in the example embodiment, the upper part of unit 1646a may be formed by a set of circumferentially expandable struts 1648a having a Z-shaped or undulating shape forming a repeating "V" shape. The struts 1648a may extend radially outward from the upper end to the lower end. These struts may generally match the size and / or shape of the struts of the inner frame 1620.

[0324] The middle part of unit 1646a may be formed by a set of pillars 1648b extending downward from the bottom ends of each “V” shape. The pillars 1648b may extend radially outward from the top end to the bottom end. The portion of unit 1646a extending upward from the bottom end of the pillars 1648b can be considered as the substantially unshortened portion of the outer frame 1640.

[0325] The lower portion of unit 1646a may be formed by a set of circumferentially expandable struts 1648c having a Z-shaped or undulating shape forming a repeating “V” shape. As shown in the example embodiment, struts 1648c may include curvature such that the lower end of strut 1648c extends more parallel to the longitudinal axis than the upper end of strut 1648c. One or more upper ends or upper tips of the circumferentially expandable struts 1648c may be “free” vertices not connected to the struts. For example, as shown in the example embodiment, every other upper end or upper tip of the circumferentially expandable strut 1648b is a free vertice. However, it should be understood that other configurations may be used. For example, each upper vertex along the upper end may be connected to a strut.

[0326] The middle and / or bottom rows of units 1646b-c may have a different shape than the first row of units 1646a. The middle row of units 1646b and the bottom row of units 1646c may have a rhomboid or approximately rhomboid shape. The rhomboid or approximately rhomboid shape may be formed by combining the supports.

[0327] The upper portion of unit 1646b may be formed by a set of circumferentially expandable struts 1648c, such that unit 1646b shares struts with unit 1646a. The lower portion of unit 1646b may be formed by a set of circumferentially expandable struts 1648d. As shown in the example embodiment, one or more of the circumferentially expandable struts 1648d may extend in a downward direction generally parallel to the longitudinal axis of the outer frame 1640.

[0328] The upper part of unit 1646c may be formed by a set of circumferentially expandable supports 1648d, such that unit 1646c shares supports with unit 1646b. The lower part of unit 1646c may be formed by a set of circumferentially expandable supports 1648e. The circumferentially expandable supports 1648e may extend generally in a downward direction.

[0329] As shown in the example implementation, there can be a row of nine units 1646a and a row of eighteen units 1646b-c. Although each of the units 1646a-c is shown to have the same shape as the other units 1646a-c in the same row, it should be understood that the shapes of the units 1646a-c within a row can be different. Furthermore, it should be understood that any number of rows of units can be used, and any number of units can be contained in these rows.

[0330] As shown in the example embodiment, the outer frame 1600 may include a set of eyelets 1650. The upper set of eyelets 1650 may extend from the upper region 1642a of the outer frame body 1642. As shown, the upper set of eyelets 1650 may extend from the upper part of unit 1646a (e.g., the upper apex of unit 1646a). The upper set of eyelets 1650 can be used to attach the outer frame 1640 to the inner frame 1620. For example, in some embodiments, the inner frame 1620 may include one or more eyelets corresponding to the eyelets 1650. In such embodiments, the inner frame 1620 and the outer frame 1640 may be attached together via the eyelets 1650 and the corresponding eyelets on the inner frame 1620. For example, the inner frame 1620 and the outer frame 1640 may be sewn together through the eyelets, or attached by other means such as mechanical fasteners (e.g., screws, rivets, etc.).

[0331] As shown, the set of eyelets 1650 may include two eyelets extending in series from each “V”-shaped strut. This reduces the likelihood of the outer frame 1640 twisting along the axis of the eyelets. However, it should be understood that some “V”-shaped struts may not include eyelets. Furthermore, it should be understood that fewer or more eyelets may extend from the “V”-shaped struts.

[0332] The outer frame 1640 may include a set of locking protrusions 1652 extending from or near the upper end of the upper region 1642a. As shown, the locking protrusions 1652 may extend upward from this set of eyelets 1650. The outer frame 1640 may include twelve locking protrusions 1652. However, it should be understood that a greater or lesser number of locking protrusions may be used. The locking protrusions 1652 may include longitudinally extending struts 1652a. At the upper end of the struts 1652a, the locking protrusions 1652 may include an enlarged head 1652b. As shown, the enlarged head 1652b may have a semi-circular or semi-elliptical shape, forming a "mushroom" shape with the struts 1652a. The locking protrusions 1652 may include eyelets 1652c, which may be positioned through the enlarged head 1652b. It should be understood that the locking protrusions 1652 may include eyelets in other locations, or may include more than one eyelet.

[0333] The locking protrusion 1652 can be advantageously used with a variety of delivery systems. For example, the shape of the strut 1652a and the enlarged head 1652b can be used to secure the outer frame 1640 to a slot-based delivery system, such as the inner retainer 40 described above. The eyeholes 1652c and / or 1650 can be used to secure the outer frame 1640 to a tether-based delivery system, such as a system that uses sutures, threads, or fingers to control the delivery of the outer frame 1640 and the prosthesis 1600. This can advantageously facilitate the recapture and repositioning of the outer frame 1640 and the prosthesis 1600 in situ.

[0334] An outer frame 1640, such as an outer frame body 1642, can be used to attach or secure the prosthesis 1600 to a natural valve, such as a natural mitral valve. For example, the intermediate region 1642b of the outer frame body 1642 and / or the outer anchoring member 1644 can be positioned to contact or engage the natural valve annulus, tissue beyond the natural valve annulus, natural leaflets, and / or other tissue located at or around the implantation site during one or more phases of the cardiac cycle, such as systole and / or diastole. As another example, the outer frame body 1642 can be sized and positioned relative to the inner frame anchoring member 1624 such that tissue within the body cavity is positioned between the outer frame body 1642 and the inner frame anchoring member 1624, such as natural valve leaflets and / or natural valve annulus, which can be engaged or compressed to further secure the prosthesis 1600 to the tissue. As shown, the inner frame anchoring member 1624 includes nine anchors; however, it should be understood that fewer or more anchors can be used. In some embodiments, the number of individual anchors may be selected as a multiple of the number of ferrules of the valve body 1660. For example, for a valve body 1660 with three ferrules, the inner frame anchoring member 1624 may have three individual anchors (1:1 ratio), six individual anchors (2:1 ratio), nine individual anchors (3:1 ratio), twelve individual anchors (4:1 ratio), fifteen individual anchors (5:1 ratio), or any other multiple of three. In some embodiments, the number of individual anchors does not correspond to the number of ferrules of the valve body 1660.

[0335] Continue to refer to Figures 39-40 In the example of the prosthesis 1600, the valve body 1660 is attached to the inner frame 1620 within the inner frame body 1622. The valve body 1660 acts as a one-way valve to allow blood to flow through the valve body 1660 in a first direction and to inhibit blood from flowing through the valve body 1660 in a second direction.

[0336] The valve body 1660 may include a plurality of leaflets 1662 joined at the commissure, such as three leaflets 1662. The valve body 1660 may include one or more intermediate members 1664. The intermediate member 1664 may be positioned between a portion or all of the leaflet 1662 and the inner frame 1620 such that at least a portion of the leaflet 1662 is coupled to the frame 1620 via the intermediate member 1664. In this manner, a portion or all of that portion of the leaflet 1662 at the commissure and / or the arcuate edge of the leaflet 1662 is not directly coupled or attached to the inner frame 1620, but is indirectly coupled to or "floats" within the inner frame 1620.

[0337] Next reference Figure 39 The example shows an outer skirt 1680, which may be attached to the inner frame 1620 and / or the outer frame 1640. As shown, the outer skirt 1680 may be positioned around and secured to a portion or all of the exterior of the outer frame 1640. The outer skirt 1680 may be attached to the valve body 1660 and the outer skirt 1680. Figure 40 As shown, a first end of the inner skirt 1690 may be coupled to the valve body 1660 along a portion of the valve body 1660 near the inner frame 1620. A second end of the inner skirt 1690 may be attached to a lower region of the outer skirt 1680. This creates a smooth surface beneath each leaflet. This beneficially enhances hemodynamics by allowing blood to circulate more freely and reducing stagnant areas.

[0338] Although the prosthesis 1600 has been described as including an inner frame 1620, an outer frame 1640, a valve body 1660, and skirts 1680 and 1690, it should be understood that the prosthesis 1600 does not need to include all components. For example, in some embodiments, the prosthesis 1600 may include the inner frame 1620, the outer frame 1640, and the valve body 1660, while omitting the skirt 1680. Furthermore, although the components of the prosthesis 1600 have been described and exemplified as separate components, it should be understood that one or more components of the prosthesis 1600 may be formed integrally or monolithically. For example, in some embodiments, the inner frame 1620 and the outer frame 1640 may be formed integrally or monolithically as a single component.

[0339] As will be appreciated from the foregoing description, inventive products and methods for implant delivery systems have been disclosed. Although several components, techniques and aspects have been described to a certain degree of specificity, it will be apparent that various changes can be made to the particular designs, constructions and methods described above without departing from the spirit and scope of this disclosure.

[0340] Some features described in this disclosure in individual embodiments may also be implemented in combination in a single embodiment. Conversely, various features described in a single embodiment may also be implemented separately in multiple embodiments or in any suitable sub-combination. Furthermore, although features may be described above as operating in certain combinations, in some cases one or more features may be removed from a claimed combination, and the combination may be claimed as any sub-combination or variation of any sub-combination.

[0341] Furthermore, although methods may be depicted in the accompanying drawings or described in the specification in a specific order, it is not necessary to perform these methods in the specific order shown or in a sequential order, nor is it necessary to perform all methods to obtain the desired results. Other methods not depicted or described may be incorporated into the example methods and processes. For example, one or more other methods may be performed before, after, simultaneously with, or between any of the described methods. Furthermore, methods may be rearranged or reordered in other embodiments. Moreover, the separation of various system components in the above embodiments should not be construed as requiring such separation in all embodiments, and it should be understood that the described components and systems can generally be integrated into a single product or packaged into multiple products. Additionally, other embodiments are also within the scope of this disclosure.

[0342] Unless otherwise specifically stated or otherwise understood in the context in which they are used, conditional language (such as "may," "can," "may," or "will") is generally intended to convey that certain implementations include or exclude certain features, elements, and / or steps. Therefore, such conditional language is generally not intended to imply that a feature, element, and / or step is necessary in any way for one or more implementations.

[0343] Unless otherwise specifically stated, connective language (such as the phrase "at least one of X, Y, and Z") is understood in context as generally used to convey that an item, term, etc., can be X, Y, or Z. Therefore, such connective language is generally not intended to imply that some implementation requires the presence of at least one of X, at least one of Y, and at least one of Z.

[0344] The degree language used herein (such as the terms "approximately," "about," "roughly," and "substantially") refers to a value, quantity, or characteristic that is close to the stated value, quantity, or characteristic and still performs the desired function or still produces the desired result. For example, the terms "approximately," "about," "roughly," and "substantially" can refer to a quantity that is less than or equal to 10% of the stated quantity, less than or equal to 5% of the stated quantity, less than or equal to 1% of the stated quantity, less than or equal to 0.1% of the stated quantity, or less than or equal to 0.01% of the stated quantity. If the stated quantity is 0 (e.g., none, not at all), then the ranges defined above can be specific ranges and not within a specific percentage of that value. For example, within 10 wt. / vol.% of the amount less than or equal to the amount, within 5 wt. / vol.% of the amount less than or equal to the amount, within 1 wt. / vol.% of the amount less than or equal to the amount, within 0.1 wt. / vol.% of the amount less than or equal to the amount, and within 0.01 wt. / vol.% of the amount less than or equal to the amount.

[0345] Some embodiments have been described with reference to the accompanying drawings. The drawings are drawn to scale, but such scale should not be limiting, as other dimensions and scales besides those shown are conceivable and within the scope of the disclosed invention. Distances, angles, etc., are merely exemplary and do not necessarily have a precise relationship to the actual size and layout of the illustrated device. Components may be added, removed, and / or rearranged. Furthermore, any particular feature, aspect, method, property, characteristic, quality, attribute, element, etc., of this disclosure may be used in combination with various embodiments in all other embodiments described herein. Additionally, it will be appreciated that any of the methods described herein can be practiced using any means suitable for performing the defined steps.

[0346] Although various embodiments and their variations have been described in detail, other modifications and methods of using them will be apparent to those skilled in the art. Therefore, it should be understood that various applications, modifications, materials, and substitutions may be made by equivalents without departing from the unique and inventive scope of this disclosure or the claims.

Claims

1. A delivery system for delivering an expandable implant to a body location, the delivery system comprising: An outer sheath assembly, the outer sheath assembly including an outer shaft having an outer cavity and a proximal and distal end, wherein the outer sheath assembly includes an implant holding region configured to retain the expandable implant in a compression configuration; A track assembly located within the outer cavity, the track assembly including a track cavity and a track shaft with a proximal end and a distal end, wherein the track assembly includes one or more pull wires attached to the inner surface of the track shaft, the pull wires being configured to provide an axial force on the track shaft to manipulate the track assembly; and An inner component located within the external cavity, the inner component including an inner shaft having an inner cavity and proximal and distal ends, wherein the inner component includes an inner retention member configured to releasably attach to the expandable implant. The outer sheath assembly and the inner assembly are configured to move together distally relative to the orbital assembly, while the expandable implant remains in the compression configuration; and The outer sheath assembly is configured to retract proximally relative to the inner assembly to at least partially allow the expandable implant to expand from the compression configuration.

2. The delivery system of claim 1, wherein the internal component is located within the orbital cavity.

3. The delivery system of claim 1 or 2, further comprising a central axis assembly within the outer cavity, the central axis assembly including a central axis having an intermediate cavity and a proximal and distal end, wherein the central axis assembly includes an outer retaining member configured to radially constrain at least a portion of the expandable implant, and wherein the central axis assembly is configured to move distally relative to the track assembly while the expandable implant is held in the compression configuration, and wherein the central axis assembly is configured to retract proximally relative to the inner assembly to completely release the expandable implant.

4. The delivery system of claim 3, wherein the track assembly is located within the intermediate cavity.

5. The delivery system of any one of the preceding claims further includes a nasal cone assembly located within the lumen, the nasal cone assembly including a nasal cone shaft having a guidewire lumen, a proximal end and a distal end, and a nasal cone on the distal end, wherein the nasal cone assembly is configured to move distally relative to the track assembly while the expandable implant is held in the compression configuration.

6. The delivery system of claim 5, wherein the nasal cone assembly is configured to move distally relative to the track assembly, together with the outer sheath assembly and the inner assembly, while the expandable implant remains in the compression configuration.

7. The delivery system of claim 1, wherein the track assembly is located within the cavity.

8. The delivery system of any of the preceding claims, wherein the track axis is configured to form a proximal bend and a distal bend.

9. The delivery system of claim 1, wherein the one or more pull wires include a proximal pull wire and a distal pull wire, wherein the proximal pull wire is attached to the track axis at a location near the attachment point of the distal pull wire.

10. The delivery system of any one of the preceding claims, further comprising a handle, wherein the handle includes a first actuator configured to move the outer sheath assembly and the inner assembly together distally.

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