Steerable rail delivery system

Abstract

This application relates to steerable rail delivery systems. Devices, systems, and methods are described herein to provide improved steerability for delivering a prosthesis to a body location, such as delivering a replacement mitral valve to a native mitral valve location. The steerable delivery system can include a steerable rail configured for multi-plane bending to direct a distal end of the delivery system.

Description

[0001] This application is a divisional application of the original application with the filing date of July 5, 2018, the application number of 201880051428.5, and the invention title of "Steerable rail delivery system". TECHNICAL FIELD

[0002] Certain embodiments disclosed herein relate generally to prostheses for implantation within a lumen or body cavity and delivery systems for prostheses. In particular, the prostheses and delivery systems relate, in certain embodiments, to replacement heart valves, such as replacement mitral heart valves. BACKGROUND

[0003] Human heart valves, including the aortic valve, the pulmonary valve, the mitral valve, and the tricuspid valve, essentially function as one-way valves that operate in synchrony with the pumping action of the heart. These valves allow blood to flow downstream but prevent blood from flowing upstream. Diseased heart valves exhibit impairments, such as narrowing or regurgitation of the valve, which inhibit the ability of the valve to control blood flow. Such impairments can reduce the efficiency of the heart in pumping blood and can debilitate and threaten the life of a person. For example, valvular insufficiency can lead to conditions such as cardiac hypertrophy and ventricular dilation. Accordingly, extensive efforts have been made to develop methods and devices to repair or replace impaired heart valves.

[0004] Prostheses exist to correct problems associated with impaired heart valves. For example, mechanical and tissue-based heart valve prostheses can be used to replace impaired native heart valves. Recently, significant efforts have been made to develop replacement heart valves, particularly tissue-based replacement heart valves, which can be less traumatic to a patient than through open-heart surgery. Replacement valves are being designed to be delivered through minimally invasive procedures and even percutaneous procedures. Such replacement valves generally include a tissue-based valve body connected to an expandable frame, which is then delivered to an annulus of a native valve.

[0005] The development of prostheses, including but not limited to replacement heart valves, which can be compacted for delivery and then controllably expanded for controlled placement, has proven particularly challenging. Another challenge relates to the ability to secure such prostheses relative to luminal tissue (e.g., tissue within any body lumen or lumen) in atraumatic manner.

[0006] Delivering a prosthesis to a desired location in the human body, such as delivering a replacement heart valve to the mitral valve, can also be challenging. Obtaining access to perform a procedure at a heart or other anatomical location can require percutaneously delivering a device through a tortuous vasculature or through a direct or semi-direct surgical procedure. The ability to control deployment of the prosthesis at the desired location can also be challenging. SUMMARY

[0007] Embodiments of the present 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 a prosthesis, such as but not limited to a replacement heart valve, to a desired location in the body. In some embodiments, a replacement heart valve and a method for delivering a replacement heart valve to a native heart valve, such as the mitral valve, are provided.

[0008] In some embodiments, a delivery system and method for delivering a replacement heart valve to a native mitral valve location are provided. The delivery system and method can utilize a trans-septal approach. In some embodiments, components of the delivery system facilitate bending of the delivery system to steer the prosthesis to a location within the native mitral valve. In some embodiments, a capsule is provided for containing a prosthesis for delivery to a native mitral valve location. In other embodiments, the delivery system and method can be adapted to deliver an implant to a location other than the native mitral valve.

[0009] The present disclosure includes, but is not limited to, the following embodiments.

[0010] Embodiment 1 : A delivery system for delivering an expandable implant to a location in the body, the delivery system comprising an outer sheath assembly comprising an outer shaft having an outer lumen and a proximal end and a distal end, wherein the outer sheath assembly comprises an implant retention area configured to retain the expandable implant in a compressed configuration; a track assembly located within the outer lumen, the track assembly comprising a track shaft having a track lumen and a proximal end and a distal end, wherein the track assembly comprises one or more pull wires attached to an inner surface of the track shaft, the pull wires configured to provide an axial force on the track shaft to steer the track assembly; and an inner assembly located within the outer lumen, the inner assembly comprising an inner shaft having an inner lumen and a proximal end and a distal end, wherein the inner assembly comprises 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 is still in the compressed configuration, and wherein the outer sheath assembly is configured to proximally retract relative to the inner assembly to at least partially expand the expandable implant from the compressed configuration.

[0011] Embodiment 2: The delivery system of embodiment 1, wherein the inner assembly is located within the track lumen.

[0012] Embodiment 3: The delivery system of Embodiments 1 or 2, further comprising a mid shaft assembly within the outer lumen, the mid shaft assembly comprising a mid shaft having a mid lumen and a proximal end and a distal end, wherein the mid shaft assembly comprises an outer retention member configured to radially constrain at least a portion of the expandable implant, and wherein the mid shaft assembly is configured to move distally relative to the track assembly while the expandable implant is still in the compressed configuration, and wherein the mid shaft assembly is configured to proximally retract relative to the inner assembly to fully release the expandable implant.

[0013] Embodiment 4: The delivery system of Embodiment 3, wherein the track assembly is within the mid lumen.

[0014] Embodiment 5: The delivery system of any of the preceding embodiments, further comprising a nose cone assembly within the inner lumen, the nose cone assembly comprising 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 is still in the compressed configuration.

[0015] Embodiment 6: The delivery system of Embodiment 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, while the expandable implant is still in the compressed configuration.

[0016] Embodiment 7: The delivery system of Embodiment 1, wherein the track assembly is within the inner lumen.

[0017] Embodiment 8: The delivery system of any of the preceding embodiments, wherein the track shaft is configured to form a proximal bend and a distal bend.

[0018] Embodiment 9: The delivery system of any of the preceding embodiments, wherein the one or more pull wires comprise a proximal pull wire and a distal pull wire, wherein the proximal pull wire is attached to the track shaft at a location proximal to an attachment point of the distal pull wire.

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

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

[0021] Embodiment 12: The delivery system of Embodiments 3 or 4, further comprising a handle, wherein the handle comprises a first actuator configured to move the outer sheath assembly, the inner assembly, and the midshaft 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 midshaft assembly proximally relative to the inner assembly.

[0022] Embodiment 13: The delivery system of Embodiments 5 or 6, further comprising a handle, wherein the handle comprises a lock button for preventing axial movement of the nosecone assembly.

[0023] Embodiment 14: The delivery system of Embodiments 3 or 4, further comprising a handle, wherein the handle comprises a single flush port, and wherein the single flush port is configured to provide fluid access between the track lumen, the outer sheath lumen, and the midshaft lumen.

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

[0025] Embodiment 16: The delivery system of Embodiment 15, wherein the expandable implant comprises a replacement mitral valve, the replacement mitral valve comprising a plurality of anchors configured to be positioned on a ventricular side of a native mitral annulus.

[0026] Embodiment 17: The delivery system of any of the preceding embodiments, wherein the track assembly is configured to steer the track assembly in a trans-septal path toward a native mitral valve location.

[0027] Embodiment 18: The delivery system of any of the preceding embodiments, wherein the track comprises at least one pull wire lumen attached to an inner surface of the track lumen, wherein at least one pull wire passes through the at least one pull wire lumen.

[0028] Embodiment 19: The delivery system of Embodiments 5 or 6, further comprising a guidewire shield having a proximal diameter that is smaller than a distal diameter, the guidewire shield being located on the nosecone shaft, wherein the guidewire sheath is configured to protect the nosecone shaft from being crushed during implant crimping, and wherein a distal end of the expandable implant is configured to radially contact the proximal diameter in the compressed configuration.

[0029] Embodiment 20: The delivery system of Embodiment 1, further comprising a mid shaft assembly within the outer lumen, the mid shaft assembly comprising a mid shaft having a mid lumen and a proximal end and a distal end, wherein the mid shaft assembly comprises an outer retention member configured to radially constrain at least a portion of the expandable implant; and a nosecone assembly within the inner lumen, the nosecone assembly comprising a nosecone shaft having a guidewire lumen, a proximal end and a distal end, and a nosecone on the distal end, wherein the mid shaft assembly and the nosecone assembly are configured to move distally relative to the track assembly, with the outer sheath assembly and the inner assembly, while the expandable implant is still in the compressed configuration, and wherein the mid shaft assembly is configured to be proximally retracted relative to the inner assembly to at least partially expand the expandable implant from the compressed position.

[0030] Embodiment 21 : The delivery system of Embodiment 3, wherein the mid shaft assembly is configured to move distally relative to the track assembly, with the outer sheath assembly and the inner assembly.

[0031] Embodiment 22: The delivery system of Embodiment 5, wherein the nosecone assembly is configured to move distally relative to the track assembly, 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 comprising an outer sheath assembly, the outer sheath assembly comprising an outer shaft having an outer lumen and a proximal end and a distal end, wherein the outer sheath assembly comprises an implant retention region configured to retain the expandable implant in a compressed configuration, wherein the outer sheath assembly comprises a capsule at the distal end, the capsule comprising an outer polymer layer, a metallic intermediate layer on a radially inner surface of the outer polymer layer, and an inner liner on a radially inner surface of the intermediate layer.

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

[0034] Embodiment 25: The delivery system of Embodiments 23 or 24, wherein the inner liner wraps around the distal end of the capsule and is in contact with a radially outer surface of the outer polymer layer.

[0035] Embodiment 26: The delivery system of any of Embodiments 23-25, further comprising a fluoroelastomer layer configured to bond the inner liner to the intermediate layer.

[0036] Embodiment 27: The delivery system of any of Embodiments 23-26, further comprising a fluorinated ethylene polymer layer between the inner layer and the metallic layer.

[0037] Embodiment 28: The delivery system of any of Embodiments 23-27, wherein the metallic intermediate layer is at least partially a metallic coil.

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

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

[0040] Embodiment 31 : A method for delivering an expandable implant to a body location, the method comprising: delivering an expandable implant within an outer sheath assembly of a delivery system toward the body location, 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 with an inner retaining member; activating a pull wire in a track assembly of the delivery system to steer the delivery system, the track assembly comprising a track shaft having a track lumen 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 relative to the track assembly to position the expandable implant at the body location while the expandable implant is still in the radially compressed configuration; and proximally retracting the outer sheath assembly relative to the inner retaining member to at least partially expand the expandable implant from the radially compressed configuration.

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

[0042] Embodiment 33: The method of Embodiment 31, wherein the inner retaining member is within the track lumen.

[0043] Embodiment 34: The method of any of Embodiments 31 -33, further comprising moving a midshaft assembly comprising an outer retaining member configured to radially constrain at least a portion of the expandable implant distally with the outer sheath assembly and the inner retaining ring to position the expandable implant at the body location while the expandable implant is still in the radially compressed configuration.

[0044] Embodiment 35: The method of Embodiment 34, further comprising proximally retracting the midshaft assembly relative to the inner retaining member to at least partially expand the expandable implant.

[0045] Embodiment 36: The method of any of Embodiments 34-35, wherein the track assembly is within the midshaft assembly.

[0046] Embodiment 37: The method of any of Embodiments 31 -33, further comprising moving a nosecone assembly comprising a nosecone shaft and a nosecone distally with the outer sheath assembly and the inner retaining member to position the expandable implant at the body location while the expandable implant is still in the radially compressed configuration.

[0047] Embodiment 38: The method of any of embodiments 31-37, further comprising activating a second pull wire in the rail assembly to form a second bend in the rail shaft.

[0048] Embodiment 39: The method of any of embodiments 31-38, wherein moving the outer sheath assembly and the inner retaining member comprises activating a first actuator on the handle.

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

[0050] Embodiment 41: The method of any of embodiments 31-40, wherein the pull wire passes through a pull wire lumen attached to an inner surface of the rail lumen.

[0051] Embodiment 42: The method of any of embodiments 31-41, wherein the body location is a native mitral valve, and wherein activating the pull wire provides at least one bend in the rail shaft to steer the delivery system toward the native mitral valve in a trans-septal path.

[0052] Embodiment 43: A delivery system for delivering an expandable implant to a body location, the delivery system comprising an outer sheath assembly comprising an outer shaft having an outer lumen and a proximal end and a distal end, wherein the outer sheath assembly comprises an implant retaining region configured to retain the expandable implant in a compressed configuration; a rail assembly located within the outer lumen, the rail assembly comprising a rail shaft having a rail lumen and a proximal end and a distal end, wherein the rail assembly comprises one or more pull wires attached to an inner surface of the rail shaft, the pull wires configured to provide an axial force on the rail shaft to steer the rail assembly; and an inner assembly located within the outer lumen, the inner assembly comprising an inner shaft having an inner lumen and a proximal end and a distal end, wherein the inner assembly comprises an inner retaining member configured to releasably attach to the expandable implant; a middle shaft assembly within the outer lumen, the middle shaft assembly comprising a middle shaft having a middle lumen and a proximal end and a distal end, wherein the middle shaft assembly comprises an outer retaining member configured to radially constrain at least a portion of the expandable implant; and a nosecone assembly located within the inner lumen, the nosecone assembly comprising a nosecone shaft having a guide wire lumen, a proximal end, and a distal end, and a nosecone on the distal end, wherein the outer sheath assembly, the middle shaft assembly, the inner assembly, and the nosecone assembly are configured to move distally together relative to the rail assembly while the expandable implant is still in the compressed configuration, and wherein the outer sheath assembly and the middle shaft assembly are configured to proximally retract separately relative to the inner assembly to at least partially expand the expandable implant from the compressed configuration.

[0053] Embodiment 44: The delivery system of embodiment 3, wherein the outer retaining member comprises an inner liner wrapped around the distal end of the outer retaining member and in contact with a radially outer surface of the member.

[0054] Implantation of a prosthetic valve in a patient is a common medical procedure. The procedure can be performed in a minimally invasive manner, for example, through a small incision in the patient's chest. The procedure can be performed using a delivery system that includes a catheter having a lumen and a distal end. The delivery system can also include a guidewire that is positioned within the lumen of the catheter. The delivery system can also include a prosthetic valve that is positioned on the guidewire. The prosthetic valve can be positioned on the guidewire in a compressed configuration. The delivery system can also include a sheath assembly that is positioned over the prosthetic valve. The sheath assembly can be configured to hold the prosthetic valve in the compressed configuration. The delivery system can also include a track assembly that is positioned within the lumen of the catheter. The track assembly can include a steerable track shaft that is configured to be actuated to include one or more bends. The delivery system can also include a handle assembly that is coupled to the catheter. The handle assembly can be configured to actuate the steerable track shaft to include the one or more bends. The delivery system can also include a sheath actuation assembly that is coupled to the sheath assembly. The sheath actuation assembly can be configured to move the sheath assembly over the track assembly in a distal direction when the prosthetic valve is positioned at a body location in the compressed configuration. The steerable track shaft can have sufficient rigidity to maintain its shape when the sheath assembly is moved over the track assembly in the distal direction. The sheath assembly can have sufficient flexibility to track over at least one of the one or more bends of the steerable track shaft when the steerable track shaft is actuated.

[0055] Other embodiments of the present disclosure include, but are not limited to, delivery systems including one or more of the features described above or further described below. For example, in one embodiment, a delivery system can include a capsule having one or more features described herein. In another embodiment, a delivery system can include a shaft having one or more features described herein. In another embodiment, a delivery system can include a guidewire guard having one or more features described herein. In another embodiment, a delivery system can include a steerable track having one or more features described herein. In another embodiment, a delivery system can include a prosthesis having one or more features described herein. In another embodiment, a delivery system can include an outer retention member having one or more features described herein. BRIEF DESCRIPTION OF DRAWINGS

[0056] Figure 1 Embodiments of a delivery system are shown.

[0057] Figure 2A Embodiments of a delivery system are shown. Figure 3A Embodiments of a delivery system are shown. Figure 1 Embodiments of a delivery system are shown.

[0058] Figure 2B Embodiments of a delivery system are shown. Figure 3A Embodiments of a delivery system are shown. Figure 1 Embodiments of a delivery system are shown.

[0059] Figure 2C Embodiments of a delivery system are shown. Figure 1 Embodiments of a delivery system are shown.

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

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

[0062] Figure 4 A perspective view of a distal end of the delivery system of Figure 1 is shown.

[0063] Figure 5 A perspective view of components of the delivery system of Figure 4 is shown, with the outer sheath assembly moved proximally and out of view.

[0064] Figure 6A A perspective view of components of the delivery system of Figure 5 is shown, with the midshaft assembly moved proximally and out of view.

[0065] Figure 6B A cross-section of a rail assembly is illustrated.

[0066] Figure 7 A perspective view of components of the delivery system of Figure 6A is shown, with the rail assembly moved proximally and out of view.

[0067] Figure 8 A perspective view of components of the delivery system of Figure 7 is shown, with the inner assembly moved proximally and out of view.

[0068] Figure 9A and 9B An embodiment of a guidewire guard is illustrated.

[0069] Figure 10 An embodiment of an outer hypotube is illustrated.

[0070] Figure 11 An embodiment of a midshaft hypotube is illustrated.

[0071] Figure 12A An embodiment of a midshaft hypotube of Figure 11 in a flattened pattern is illustrated.

[0072] Figure 12B An embodiment of an outer retention ring is illustrated.

[0073] Figure 13 An embodiment of a rail assembly is illustrated.

[0074] Figure 14 An embodiment of an inner assembly is illustrated.

[0075] Figure 15 A cross-section of a capsule is illustrated.

[0076] Figure 16 An embodiment of a delivery system handle is illustrated.

[0077] Figure 17 An embodiment of a delivery system handle is illustrated. Figure 16 A cross-section of a delivery system handle is illustrated.

[0078] Figure 18 A schematic view of a spaced delivery path is illustrated.

[0079] Figure 19 A schematic view of a valve prosthesis positioned within a native mitral valve is illustrated.

[0080] Figure 20 A valve prosthesis frame positioned within a heart is shown.

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

[0082] Figure 24A A method of rail delivery system is illustrated.

[0083] Figure 25 An alternative embodiment of a delivery system is shown.

[0084] Figure 26A A partial cross-sectional view of a distal end of a delivery system loaded with a valve prosthesis is shown. Figure 3A Figure 25 A partial cross-sectional view of a distal end of a delivery system loaded with a valve prosthesis is shown.

[0085] Figure 26B A partial cross-sectional view of a distal end of a delivery system loaded with a valve prosthesis is shown. Figure 3A Figure 25 A partial cross-sectional view of a distal end of a delivery system loaded with a valve prosthesis is shown.

[0086] Figure 26C A partial cross-sectional view of a distal end of a delivery system loaded with a valve prosthesis is shown. Figure 3A A partial cross-sectional view of a distal end of a delivery system loaded with a valve prosthesis is shown.

[0087] Figure 27 A perspective view of a distal end of a delivery system is shown. Figure 25 A perspective view of a distal end of a delivery system is shown.

[0088] Figure 28 A perspective view of a distal end of a delivery system is shown. Figure 27 A perspective view of a distal end of a delivery system is shown.

[0089] Figure 29 A perspective view of a distal end of a delivery system is shown. Figure 28 A perspective view of a distal end of a delivery system is shown.​​

[0090] Figure 30 An embodiment of an outer hypotube is shown.

[0091] Figure 31 An embodiment of an inner hypotube is shown.

[0092] Figure 32 An embodiment of a rail hypotube is shown.

[0093] Figure 33 An embodiment of a delivery system handle is shown.

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

[0095] Figure 37 A side view of an embodiment of a valve prosthesis deliverable using the delivery systems described herein is shown.

[0096] Figure 38A-40 A view of an embodiment of a valve prosthesis deliverable using the delivery systems described herein is shown. DETAILED DESCRIPTION

[0097] The present disclosure provides aspects and features in the context of several embodiments of replacement heart valves, delivery systems, and methods configured for use in a patient's vasculature, such as for replacing a native heart valve in a patient. The embodiments can be discussed in connection with replacing a particular valve, such as a patient's aortic valve, tricuspid valve, or mitral valve. However, it should be understood that the features and concepts discussed herein can be applied 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 elsewhere in the body, such as within an artery, vein, or other body lumen or location. Additionally, the specific features of the valves, delivery systems, etc. should not be considered limiting, and features of any one embodiment discussed herein can be combined with features of other embodiments as desired and as appropriate. While certain embodiments described herein are described in connection with a transfemoral arterial delivery path, it should be understood that these embodiments can be used in other delivery paths, such as, for example, transapical or transjugular vein paths. Also, it should be understood that certain features described in connection with some embodiments can be combined with other embodiments, including those described in connection with different delivery paths.

[0098] Delivery system

[0099] Figure 1Embodiments of a delivery device, system, or assembly 10 are illustrated. The delivery system 10 can be used to deploy a prosthesis, such as a replacement heart valve, in vivo. In some embodiments, the delivery system 10 can use a bi-plane deflection path to properly deliver a prosthesis. Replacement heart valves can be delivered to a patient's mitral annulus or other heart valve location in various ways, such as through open surgery, minimally invasive surgery, and percutaneously or transcatheter through a patient's vasculature. An exemplary transfemoral arterial path can be found in U.S. Patent Publication No. 2015 / 0238315, filed February 20, 2015, incorporated by reference herein in its entirety. Although the delivery system 10 is described in connection with a percutaneous delivery path, and more specifically a transfemoral arterial delivery path, it will be appreciated that features of the delivery system 10 can be applied to other delivery systems, including delivery systems for transapical delivery paths.

[0100] The delivery system 10 can be used to deploy a prosthesis, such as a replacement heart valve as described elsewhere in this specification. The delivery system 10 can receive and / or cover portions of the prosthesis, such as the first end 301 and the second end 303 of the prosthesis 70 as shown in Figure 3A The delivery system 10 can be used to deliver an expandable implant or prosthesis 70, for example, where the prosthesis 70 includes a first end 301 and a second end 303, and where the second end 303 is configured to be deployed or expanded before the first end 301.

[0101] Figure 2A Further examples of a prosthesis 70 that can be inserted into the delivery system 10, and in particular into the implant retention region 16, are shown. For ease of understanding, the prosthesis is shown in Figure 2A The implant or prosthesis 70 can take any number of different forms. Although a specific example of a frame of a prosthesis is shown in Figure 3A The prosthesis 70 can include one or more sets of anchors, such as distal (or ventricular) anchors 80 that extend proximally when the prosthesis frame is in an expanded configuration and proximal (or atrial) anchors 82 that extend distally when the prosthesis frame is in an expanded configuration. The prosthesis can further include struts 72 that can terminate at a mushroom-shaped tab 74 at the first end 301. Further discussion can be found in U.S. Publication No. 2015 / 0328000 Al, published November 19, 2015, incorporated by reference herein in its entirety.

[0102] In some embodiments, the delivery system 10 can be used with a catheter system such as 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.

[0103] 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.

[0104] 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).

[0105] 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 2AThe implant retention region 16 is shown in FIG. B at the distal end of the delivery system 10, but can also be in other locations. In some embodiments, the prosthesis 70 can be rotated in the implant retention region 16, such as by rotation of the inner shaft assembly 18 discussed herein.

[0106] As Figure 2A As shown in the cross-sectional view of FIG. B, the distal end of the delivery system 10 can include one or more subassemblies, such as the outer sheath assembly 22, the middle shaft assembly 21, the rail assembly 20, the inner shaft assembly 18, and the nosecone assembly 31, as will be described in more detail below. In some embodiments, the delivery system 10 can not have all of the assemblies disclosed herein. For example, in some embodiments, as described below in the embodiments of FIG. C, the complete middle shaft assembly can not be incorporated into the delivery system 10. In some embodiments, the assemblies disclosed below can be in a different radial order than the order discussed. Figures 25-36

[0107] In particular, the disclosed embodiments of the delivery system 10 can utilize a steerable rail in the rail assembly 20 to steer the distal end of the delivery system 10, allowing the implant to be properly positioned in the patient. As discussed in detail below, the steerable rail can be, for example, a rail shaft that extends from the handle 14 through the delivery system 10 generally to the distal end. In some embodiments, the steerable rail has a distal end that terminates proximate the implant retention region 16. A user can steer the bend of the distal end of the rail, causing the rail to bend in a particular direction. In preferred embodiments, the rail has more than one bend along its length, providing multiple bending directions. As the rail is bent, it presses against other assemblies, causing them to bend as well, and thus, the other assemblies of the delivery system 10 can be configured to steer with the rail as a single, cooperating unit, providing full steerability of the distal end of the delivery system.

[0108] ​Once the rail is navigated to a particular location within the patient, the prosthesis 70 can be advanced along or relative to the rail and released into the body by movement of the other sheaths / shafts relative to the rail. For example, the rail can be bent into a desired location within the body to direct the prosthesis 70, such as toward a native mitral valve. The other components (e.g., outer sheath component 22, middle shaft component 21, inner component 18, and nosecone component 31) can passively follow the bending of the rail. Additionally, the other components (e.g., outer sheath component 22, middle shaft component 21, inner component 18, and nosecone component 31) can be advanced together relative to the rail (e.g., together relatively, sequentially with one actuator, simultaneously, nearly simultaneously, at the same time, at nearly the same time, at the same moment, at nearly the same moment) while maintaining the prosthesis 70 in a compressed position without releasing or expanding the prosthesis 70 (e.g., within the implant holding region 16). The other components (e.g., outer sheath component 22, middle shaft component 21, inner component 18, and nosecone component 31) can be advanced together distally or proximally relative to the rail. In some embodiments, only the outer sheath component 22, middle shaft component 21, and inner component 18 are advanced together over the rail. Thus, the nosecone component 31 can remain in the same position. The components can be translated individually, sequentially, or simultaneously relative to the inner component 18 to release the implant 70 from the implant holding region 16.

[0109] Figure 2C A sheath component (particularly the outer sheath component 22), middle shaft component 21, inner shaft component 18, and nosecone component 31 that have been translated together distally along the rail component 20 are illustrated, with further details of the relevant components below. In some embodiments, the outer sheath component 22, middle shaft component 21, inner shaft component 18, and nosecone component 31 are translated together (e.g., together relatively, sequentially with one actuator, simultaneously, nearly simultaneously, at the same time, at nearly the same time, at the same moment, at nearly the same moment). This distal translation can occur while the implant 70 is still in a compressed configuration within the implant holding region 16.

[0110] As Figure 2A-2C 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.

[0111] 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.

[0112] 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 some embodiments, 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 can receive and engage the strut 72, which can terminate in a mushroom-shaped protrusion 74 on the proximal end of the prosthesis 70. The midshaft assembly 21 can be positioned over 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 midshaft assembly 21 and the outer retaining ring 42. The outer sheath assembly 22 can be positioned to cover the second end 303 of the prosthesis 70.

[0113] The outer retaining member 42 can be attached to the distal end of the midshaft hypotube 43, which can in turn be attached at the proximal end to the proximal tube 44, which can in turn be attached at the proximal end 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 over 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 encircle a portion of the prosthesis 70, specifically the first end 301, thereby preventing the prosthesis 70 from expanding. Further, the midshaft 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 manner, the outer retaining member 42 can be used to help secure the prosthesis 70 to the delivery system 10 or release it therefrom. While the outer retaining member 42 can have a cylindrical or elongated tubular shape, and can be referred to as an outer retaining ring, the specific shape is not limiting.

[0114] The midshaft hypotube 43 itself can be made of, for example, high density polyethylene (HDPE), as well as other suitable materials as described herein. The midshaft hypotube 43 can be formed from a longitudinally pre-compressed HDPE tube, which can provide certain benefits. For example, the pre-compressed HDPE tube can exert a distal force on the outer retaining member 42, thereby preventing the prosthesis 70 from being accidentally, unintentionally, and / or prematurely released. Specifically, the distal force through the midshaft hypotube 43 keeps the distal end of the outer retaining member 42 distal of the inner retaining member 40, thereby preventing the outer retaining member 42 from moving proximally of the inner retaining member 40 before the user desires 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 retaining member 42 and the midshaft hypotube 43 can be found in U.S. Patent Publication No. 2016 / 0317301, incorporated by reference herein in its entirety.

[0115] As 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.

[0116] 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.

[0117] Delivery system components

[0118] Figure 4-8 Another view of the delivery system 10 is shown, in which the different components are translated proximally and described in detail.

[0119] 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.

[0120] 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.

[0121] The capsule 106 can be located at the distal end of the outer proximal shaft 102. The capsule 106 can be a tube formed of a plastic or metallic material. In some embodiments, the capsule 106 is formed of ePTFE or PTFE. In some embodiments, the capsule 106 is relatively thick to prevent tearing and to help maintain the self-expanding implant in a compact configuration. In some embodiments, the material of the capsule 106 is the same as the coating on the outer hypotube 104. As shown, the capsule 106 can be larger in diameter than the outer hypotube 104, but in some embodiments, the capsule 106 can be similar in diameter to the hypotube 104. In some embodiments, the capsule 106 can include a larger diameter distal portion and a smaller diameter proximal portion. In some embodiments, there can be a step or taper between the two portions. The capsule 106 can be configured to hold the prosthesis 70 in a compressed position within the capsule 106. Further details of the construction of the capsule 106 are discussed below.

[0122] The outer sheath assembly 22 is configured to slide independently relative to the other assemblies. In addition, the outer sheath assembly 22 can slide distally and proximally relative to the track assembly 22 along with the middle shaft assembly 21, the inner assembly 18, and the nosecone assembly 31.

[0123] Moving radially inward, the next assembly is the middle shaft assembly 21. Figure 5 A similar view is shown, but with the outer sheath assembly 22 removed, exposing the middle shaft assembly 21. Figure 4

[0124] The middle shaft assembly 21 can include a middle shaft hypotube 43 attached at its proximal end to a middle shaft proximal tube 44, which in turn can be attached at its proximal end to the handle 14, and an outer retention ring 42 at the distal end of the middle shaft hypotube 43. Thus, the outer retention ring 42 can be attached at the distal end of the middle shaft hypotube 43. These components of the middle shaft assembly 21 can form a lumen through which other subassemblies can pass.

[0125] Similar to the other assemblies, the middle shaft hypotube 43 and / or the middle shaft proximal tube 44 can include a tube, such as a subcutaneous tube or a hypotube (not shown). The tube can be made of one of any number of different materials, including nitinol, stainless steel, and medical grade plastic. The tube can be a single piece tube or multiple pieces of tube connected together. Using a tube made of multiple pieces can allow different properties, such as rigidity and flexibility, to be provided along different sections of the tube. The middle shaft hypotube 43 can be a metallic hypotube, which in some embodiments can be cut or have slots, as discussed in detail below. The middle shaft hypotube 43 can be covered or encapsulated by a layer of ePTFE, PTFE, or other material, such that the outer surface of the middle shaft hypotube 43 is generally smooth.

[0126] ​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.

[0127] 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.

[0128] 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.

[0129] 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.

[0130] In some embodiments, the distal pull wire 138 can extend to a distal section of the rail hypotube 136, while two proximal pull wires 140 can extend to a proximal section of the rail hypotube 136, although other numbers of pull wires can be used, and the specific number of pull wires is not limited. For example, two pull wires can extend to the distal position, while a single pull wire can extend to the proximal position. In some embodiments, the annular structures attached to the interior of the rail hypotube 136, such as the proximal ring 137 and the distal ring 135, referred to as pull wire connectors, can be used as attachment locations for the pull wires. In some embodiments, the rail assembly 20 can include a distal pull wire connector 135 and a proximal pull wire connector 139. In some embodiments, the pull wires can be connected directly to the inner surface of the rail hypotube 136.

[0131] The distal pull wire 138 can be connected (alone or through the connector 135) approximately at the distal end of the rail hypotube 136. The proximal pull wires 140 can be connected at a location that is approximately one quarter, one third, or one half of the length of the rail hypotube 136 from the proximal end (alone or through the connector 137). In some embodiments, the distal pull wire 138 can pass through a small diameter pull wire lumen 139 (e.g., tube, hypotube, cylinder) attached on the interior of the rail hypotube 136. This can prevent the wire 138 from pulling on the rail hypotube 136 near the distal connection. In addition, the lumen 139 can act as a compression coil to stiffen the proximal portion of the rail hypotube 136 and prevent unwanted bending. Thus, in some embodiments, the lumen 139 is only on the proximal half of the rail hypotube 136. In some embodiments, each distal wire 139 can use multiple lumens 139, such as longitudinally spaced or adjacent. In some embodiments, each distal wire 139 uses a single lumen 139. In some embodiments, the lumen 139 can extend into the distal half of the rail hypotube 136. In some embodiments, the lumen 139 is attached to the outer surface of the rail hypotube 136. In some embodiments, no lumen 139 is used.

[0132] For pairs of proximal pull wires 140, the wires can be spaced approximately 180° from each other to allow manipulation in two directions. Similarly, if a pair of distal pull wires 138 is used, the wires can be spaced approximately 180° from each other to allow manipulation in two directions. In some embodiments, the pair of distal pull wires 138 and the pair of proximal pull wires 140 can be spaced approximately 90° from each other. In some embodiments, the pair of distal pull wires 138 and the pair of proximal pull wires 140 can be spaced approximately 0° from each other. However, other positions of the pull wires can also be used, and the specific position of the pull wires is not limited. In some embodiments, the distal pull wires 138 can pass through a lumen 139 attached within a lumen of the rail hypotube 136. This can prevent axial forces on the distal pull wires 138 from creating a bend in the proximal section of the rail hypotube 136.

[0133] The rail assembly 20 is arranged so that it can slide over the inner shaft assembly 18 and the nosecone assembly 31. In some embodiments, the outer sheath assembly 22, the middle shaft assembly 21, the inner shaft assembly 22, and the nosecone assembly 31 can be configured to slide together along or relative to the rail assembly 20, such as proximally and distally together with or without any bending of the rail assembly 20. In some embodiments, the outer sheath assembly 22, the middle shaft assembly 21, the inner shaft assembly 22, and the nosecone assembly 31 can be configured to hold the implant 70 in a compressed position when they are simultaneously slid along or relative to the rail assembly 20.

[0134] Moving radially inward, the next assembly is the inner shaft assembly 18. Figure 7 The same view is shown, but with the rail assembly 20 removed, exposing the inner shaft assembly 18. Figure 6A The same view is shown, but with the rail assembly 20 removed, exposing the inner shaft assembly 18.

[0135] The inner shaft assembly 18 can include an inner shaft 122 attached at its proximal end to the handle 14, and an inner retention ring 40 at the distal end of the inner shaft 122. The inner shaft 122 itself can consist of an inner proximal shaft 124 attached directly at its proximal end to the handle 14, and a distal section 126 attached to the distal end of the inner proximal shaft 124. Thus, the inner retention ring 40 can be attached at the distal end of the distal section 126. These components of the inner shaft assembly 18 can form lumens for other subassemblies to pass through.

[0136] Like other components, inner proximal shaft 124 can include a tube, such as a hypodermic tube or a hypotube (not shown). The tube can be made of one of any number of different materials, including nitinol, cobalt-chrome, stainless steel, and medical grade plastic. The tube can be a single piece tube or a multi-piece tube that is connected together. Tubes that include multiple pieces can provide different properties, such as rigidity and flexibility, along different sections of the tube. Distal section 126 can be a metallic hypotube, which in some embodiments can be cut or have slots, as discussed in detail below. Distal section 126 can be covered or encapsulated by a layer of ePTFE, PTFE, or other material, such that the outer surface of distal section 126 is generally smooth.

[0137] Inner retention member 40 can be configured as a prosthesis retention mechanism that can be used to engage with prosthesis 70, as discussed with respect to Figure 2A For example, inner retention member 40 can be a ring and can include a plurality of slots configured to engage with struts 72 on prosthesis 70. Inner retention member 40 can also be considered part of implant retention region 16 and can be at the proximal end of implant retention region 16. With struts or other portions of prosthesis 70 engaged with inner retention member 40, outer retention ring 42 can cover both the prosthesis and inner retention member 40 to secure the prosthesis on delivery system 10. Thus, prosthesis 70 can be sandwiched between inner retention member 40 of inner shaft assembly 18 and outer retention ring 42 of middle shaft assembly 21.

[0138] Inner shaft assembly 18 is arranged so that it can be slid independently with respect to the other components. In addition, inner assembly 18 can be slid distally and proximally with respect to track assembly 22, along with outer sheath assembly 22, middle shaft assembly 21, and nosecone assembly 31.

[0139] Further inward from inner shaft assembly 18 is nosecone assembly 31, also as shown in Figure 8 This can be a nosecone shaft 27 and in some embodiments can have a nosecone 28 on its distal end. Nosecone 28 can be made of polyurethane for atraumatic access and to minimize damage to the venous vasculature. Nosecone 28 can also be radiopaque to provide visibility under fluoroscopy.

[0140] Nosecone shaft 27 can include a lumen sized and configured to slidably receive a guidewire so that delivery system 10 can be advanced over the guidewire through the vasculature. However, embodiments of system 10 discussed herein can not use a guidewire, so nosecone shaft 27 can be solid. Nosecone shaft 27 can be connected to the handle from nosecone 28 or can be formed from different parts such as other components. In addition, nosecone shaft 27 can be formed from different materials (such as plastic or metal) similar to the materials described in detail above.

[0141] 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.

[0142] Advantageously, the guidewire guard 1200 allows for smooth guidewire tracking during implant loading 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.

[0143] 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.

[0144] 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.

[0145] Figure 9BA substitute embodiment of a guidewire guard 1200' having a more tapered configuration is shown. As shown, the proximal end 1206' of the guidewire guard 1200' can be a single radially outward taper 1208' to the distal end 1204' of the guidewire guard 1200', which can be generally cylindrical. The guidewire guard 1200' can also include a lumen 1202' for receiving the nosecone shaft 27.

[0146] The nosecone assembly 31 is arranged so that it can be slid independently relative to the other assemblies. In addition, the nosecone assembly 31 can be slid distally and proximally relative to the rail assembly 22, along with the outer sheath assembly 22, the midshaft assembly 21, and the inner assembly 18.

[0147] In some embodiments, one or more spacer sleeves (not shown) can be used between different assemblies of the delivery system 10. For example, a spacer sleeve can be concentrically located between the midshaft assembly and the rail assembly 20, generally between the mid 43 and the rail hypotube 136. In some embodiments, the spacer sleeve can be generally embedded in the hypotube 43 of the midshaft assembly 21, such as on the inner surface of the midshaft assembly 21. In some embodiments, a spacer sleeve can be concentrically located between the rail assembly 20 and the inner assembly 18, generally within the rail hypotube 136. In some embodiments, a spacer sleeve can be used between the outer sheath assembly 22 and the midshaft assembly 21. In some embodiments, a spacer sleeve can be used between the inner assembly 18 and the nosecone assembly 31. In some embodiments, 4, 3, 2, or 1 of the above-described spacer sleeves can be used. A spacer sleeve can be used in any of the above- described locations.

[0148] The spacer sleeve can be made of a polymeric material, such as braided Pebax®, and can be lined on the inner diameter with, for example, PTFE, although the specific material is not limited. The spacer sleeve can advantageously reduce friction between the steerable rail assembly 20 and its surrounding assemblies. Thus, the spacer sleeve can act as a buffer between the rail assembly 20 and the inner assembly 18 / nosecone assembly 30. In addition, the spacer sleeve can occupy any radial gap between the assemblies, thereby preventing the assemblies from being compressed or snaking during steering. In some embodiments, the spacer sleeve can include a cutout or slot to facilitate bending of the spacer sleeve. In some embodiments, the spacer sleeve can not include any slot and can be a smooth cylindrical feature.

[0149] The spacer sleeve can be mechanically contained by other lumens and components, and thus non-physically attached to any other components, allowing the spacer sleeve to "float" in that area. The floating aspect of the spacer sleeve allows it to move where it is needed during deflection, and provides a bearing surface(s) of support and / or lubrication. Thus, the floating aspect allows the delivery system 10 to maintain a flexing force. However, in some embodiments, the spacer sleeve can be connected to other components.

[0150] Hypobo air tube / shaft construction

[0151] 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.

[0152] 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.

[0153] 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.

[0154] For example, the proximal end of the central hypotube 43 can be a first section 210 having a plurality of circumferentially extending pairs of slots 213 longitudinally spaced along the first section 211. Generally, two slots are cut around each circumferential location, forming almost half of the circumference. Thus, two "backbones" 215 are formed between the slots 213 extending along the length of the first section 211. The pairs of slots 213 can be comprised of a first thin slot 217. The second slot 221 of each pair of slots 213 can be thicker than the first slot 217, such as 1, 2, 3, 4, or 5 times as thick. In some embodiments, the second slot 217 can have substantially the same longitudinal thickness throughout the slot. In some embodiments, each slot in the pair of slots 213 can terminate in a teardrop shape 219 to facilitate bending.

[0155] Moving distally, the central hypotube 43 can include a second section 220 having a plurality of pairs of slots 222. Similar to the first section 211, the second section 220 can have a plurality of circumferentially extending slots longitudinally spaced along the second section 220. Generally, two slots are cut around each circumferential location (e.g., one pair of slots 222), forming almost half of the circumference. Thus, a "backbone" 224 is formed between the slots extending along the length of the second section 220. Each pair of slots 222 can include a first slot 226 that is generally thin and unshaped (e.g., it can look the same as the slots 213 in the first section 211) and a second slot 228 that is significantly thicker in the longitudinal direction than the first slot 226. The second slot 228 can be narrower at its ends and thicker in the middle portion longitudinally, forming a curvilinear slot. Moving longitudinally along the second section 220, each pair of slots 222 can be offset by about 45 degrees or 90 degrees compared to the longitudinally adjacent pair of slots 222. In some embodiments, the second pair of slots 222 is offset 90 degrees from the adjacent first pair of slots 222, and a third pair of slots 222 adjacent to the second pair of slots 222 can have the same configuration as the first pair of slots 222. This repeating pattern can extend along the length of the second section 220, providing a specific bending direction caused by the second slot 228 of the pair of slots 222. Thus, the "backbone" 224 is shifted circumferentially due to the offset of the adjacent shifted pair of slots 222. In some embodiments, each slot in the pair of slots 222 can terminate in a teardrop shape 229 to facilitate bending.

[0156] 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.

[0157] 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.

[0158] 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.

[0159] In some embodiments, the outer retaining ring 42 may further include an inner liner for a smooth transition onto 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.

[0160] 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.

[0161] 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.

[0162] 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.

[0163] Move radially inward, in Figure 14In some embodiments, the inner assembly 18 is substantially comprised of two sections. The proximal section is a slotted or unslotted hypotube 129. The distal section 126, which at least partially overlaps the outer surface of the proximal hypotube 129, can be designed to be particularly flexible. For example, the distal section 126 can be more flexible than any of the other shafts discussed herein. In some embodiments, the distal section 126 can be more flexible than any of the shafts discussed herein except for the nosecone shaft 27. In some embodiments, the distal section 126 can be a flexible tube or hypotube. In some embodiments, the distal section 126 can be a cable, such as a flexible cable. For example, a cable can have 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 bend more easily with the rail assembly 20. In addition, the cable can be smooth, which allows the rail assembly 20 to track over smooth surfaces, eliminating the need for any inner liner on the rail assembly 20.

[0164] Capsule structure

[0165] The capsule 106 can be formed from one or more materials, such as PTFE, ePTFE, polyether block amide (Pebax®), polyetherimide (Ultem®), PEEK, urethane, nitinol, stainless steel, and / or any other biocompatible material. The capsule is preferably compliant and flexible, while still maintaining a sufficient degree of radial strength to maintain the replacement valve within the capsule 106 without significant radial deformation, which can increase friction between the capsule 106 and the replacement valve 70 contained therein. The capsule 106 also preferably has sufficient column strength to resist buckling of the capsule and has sufficient tear resistance to reduce or eliminate the likelihood of the replacement valve tearing and / or damaging the capsule 106. The flexibility of the capsule 106 can be advantageous, particularly for a trans-septal approach. For example, when retracted along a curved member, such as when tracking over a rail assembly described herein, the capsule 106 can bend to follow the curved member without exerting a great deal of force on the curved member, which can cause the curved member to decrease in radius. More particularly, when the capsule 106 is retracted along such a curved member, the capsule 106 can bend and / or kink such that the radius of the curved member is substantially unaffected.

[0166] Figure 15An 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.

[0167] 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.

[0168] 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.

[0169] 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.

[0170] 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).

[0171] 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.

[0172] The distal-most end of the metal layer 404 can be formed of a small coil. Moving proximally, the metal layer 404 can then transition to a large coil section, followed by a small coil section, and then finally, the most proximal section can be a spaced large coil. As an exemplary set of lengths, but not by way of limitation, the distal-most small coil section can be 10 mm (or about 10 mm) in length. Moving proximally, the adjacent large coil section can extend 40 mm (or about 40 mm) to 60 mm (or about 60 mm) in length. These two sections can be found in the distal metal coil 108 shown in FIG. 4B. Moving to the proximal metal coil 107 shown in FIG. 4A, the small coil section can be 10 mm (or about 10 mm) in length. The remainder of the proximal metal coil 107 can be a spaced large coil section. The spaced large coil section can be 40 mm (or about 40 mm) to 60 mm (or about 60 mm) or more in length. Figure 10 Figure 10

[0173] As noted, the metal layer 404 (coil or hypotube) can be covered by an outer polymer layer or jacket 402. In some embodiments, the outer polymer 402 layer is an elastomer, although the specific material is not limited. In some embodiments, the outer polymer layer 402 can comprise polytetrafluoroethylene (PTFE) or expanded polytetrafluoroethylene (ePTFE). ePTFE can have very different mechanical properties than PTFE. For example, ePTFE can have much greater flexibility while still maintaining good tensile / elongation properties. In some embodiments, the outer polymer layer 402 can comprise a thermoplastic elastomer, such as PEBAX®. In some embodiments, the outer polymer layer 402 can be pre-axially stressed prior to application to the capsule. The thickness of the outer polymer layer 402 can be approximately 0.006 to 0.008 inches, although the specific thickness is not limited.

[0174] The outer polymer layer 402 can be applied to the metal layer 404, such as by reflowing the polymer, to form the outer jacket. 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 facilitate attachment of the outer polymer layer to the metal layer. For example, a fluoropolymer or other durometer fluoroeiastomer 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.

[0175] ​​In some embodiments, other materials can be included between the metal layer 404 and the outer polymer layer 402 to improve properties. For example, a fluorinated ethylene propylene (FEP) section 408 can improve radial strength, particularly when the implant is in a compressed configuration. Although an FEP layer 408 is discussed as a specific material, other high strength polymers, metals, or ceramics can also be used, and the specific material is not limited. In some cases, the FEP layer 408 can also act as an adhesive.

[0176] The FEP section 408 can be included at the distal and proximal ends of the capsule 106. The FEP section 408 can overlap the adhesive layer 406. Thus, the FEP section 408 can be located between the adhesive layer 406 and the metal layer 404, or between the adhesive layer 406 and the outer polymer layer 402. In some embodiments, the FEP section 408 can be located in a section of the capsule 106 that does not include the adhesive layer 406.

[0177] Without limitation to a specific length, the FEP section 408 located at the distal end of the capsule 106 can have a length of 10 mm (or about 10 mm). In some embodiments, the FEP section 408 has a thickness of about 0.003 inches, although this thickness can vary and is not limited by the present disclosure. In some embodiments, different FEP sections 408 (e.g., proximal and distal sections) can have different thicknesses. In some embodiments, all of the FEP 408 layers have the same thickness. An exemplary thickness can be 0.006 inches or 0.003 inches.

[0178] Moving to the interior of the metal layer 404, a liner 410 can be included on its radially inner surface. The liner 410 can be formed of a low friction and / or high lubricity material that allows the capsule 106 to translate over the prosthesis 70 without catching or damaging portions of the prosthesis 70. In some embodiments, the liner 410 can be PTFE, which can resist radial expansion and reduce friction with the prosthesis 70.

[0179] 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 106. Therefore, the ePTFE liner layer 410 can be pre-compressed before it is applied to the inner layer of the capsule 106. In some embodiments, portions of the outer polymer layer 402 and the liner 410 can 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. The layers can then be bonded together using a reflow soldering technique during manufacturing. For example, the ePTFE liner 410 can be axially compressed, such as over a mandrel, and the outer polymer layer 402 can be placed over it. The two layers can then be reflow soldered (e.g., melted under pressure) to be joined. The combined layers can be slipped into and / or around the metal layer 404 discussed herein, and can be melted again under pressure to form the final capsule 106. This technique can allow the capsule 106 to maintain flexibility and prevent breakage / tearing.

[0180] As noted, in some embodiments, the inner liner 410 can be ePTFE. The surface friction of ePTFE can be about 15% less than standard PTFE, and can be about 40% less than standard extruded thermoplastics used in the art.

[0181] In certain embodiments, the liner layer 410 can extend only along the inner surface of the capsule 106 and terminate at the distal end. However, to prevent delamination during loading of the implant 70, the liner 410 can not be flush at the distal end of the capsule 106. Instead, the liner 410 can extend and invert at the distal end to cover the distal end of the capsule 106 and the outer diameter of a portion of the outer polymer layer 402. This can form a seamless, rolled, reinforced tip of the liner 410. This solution is superior to previously known methods, such as the method disclosed in U.S. Patent No. 6,622,367, which is incorporated by reference herein in its entirety, because the application of the PTFE-lining is not particularly well adhered 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 that can reduce delamination. Delamination is a serious problem because a delaminated liner can tear and embolize during deployment, and delaminated layers can cause extremely high loading and deployment forces. Delaminated layers can also cause problems with lumen translation by locking the shaft, thereby increasing the need for translation force.

[0182] In some embodiments, another FEP section 412 can be included between the liner 410 and the metal layer 404. The FEP section 412 can be located over 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 can partially or completely continue into the proximal metal coil 107.

[0183] In some embodiments, a FEP segment 412 can be included in the most proximal portion of the proximal metal coil 107. This FEP segment 412 is approximately 0.5 inches in length. In some embodiments, there is a longitudinal gap between the most proximal FEP segment 412 and the FEP segment 412 that extends over the distal metal coil 108. In some embodiments, the previously mentioned FEP segment 412 is continuous.

[0184] As shown in FIG. 4A, the metal layer 404 can stop proximate the edges of the outer polymer layer 402, the liner 410, and the FEP segment 412. If so, a thicker portion of the adhesive layer 409 can be applied at the distal end of the metal layer 404 to match the distal end of the other layers. However, this segment can be removed during manufacturing, so the distal end of the metal layer 404 is the distal end of the capsule 106, which can then be covered by the liner 410. In some embodiments, the extended segment distal of the metal layer 404 is not used. Figure 15

[0185] handle The handle 14 is at the proximal end of the delivery system 10, and is shown in FIG. 1. The cross-section of the handle 14 is shown in FIG. 2. The handle 14 can include a plurality of actuators (such as rotatable knobs) that can manipulate different components of the delivery system 10. The operation of the handle 10 is described with reference to the delivery of the replacement mitral valve prosthesis 70, but the handle 10 and delivery system 10 can also be used to deliver other devices.

[0186] Figure 16 Figure 17 The handle 14 is generally comprised of two housings - a track housing 202 and a delivery housing 204, with the track housing 202 disposed circumferentially around the delivery housing 204. The inner surface of the track housing 202 can include a threadable segment that is configured to mate 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., thread) within the track housing 202. The track housing 202 generally surrounds about half the length of the delivery housing 204, so the delivery housing 204 extends outside of the track housing 202 both proximally and distally.

[0187] The handle 14 is generally comprised of two housings - a track housing 202 and a delivery housing 204, with the track housing 202 disposed circumferentially around the delivery housing 204. The inner surface of the track housing 202 can include a threadable segment that is configured to mate 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., thread) within the track housing 202. The track housing 202 generally surrounds about half the length of the delivery housing 204, so the delivery housing 204 extends outside of the track housing 202 both proximally and distally.

[0188] ​​The rail housing 202 can include two rotatable knobs - a distal pull wire knob 206 and a proximal pull wire knob 208. However, the number of rotatable knobs on the rail housing 202 can vary depending on the number of pull wires used. Rotation of the distal pull wire knob 206 can provide a proximal force, providing an axial pull on the distal pull wire 138 and causing the distal slotted section 135 of the rail hypotube 136 to bend. The distal pull wire knob 206 can be rotated in either direction, allowing bending in either direction, which can control the anterior-posterior angle. Rotation of the proximal pull wire knob 208 can provide a proximal force on the proximal pull wire 140, and thus an axial pull, causing the proximal slotted section 133 of the rail hypotube 136 to bend, which can control the medial-lateral angle. The proximal pull wire knob 108 can be rotated in either direction, allowing bending in either direction. Thus, when both knobs are actuated, there can be two bends in the rail hypotube 136, allowing for three-dimensional manipulation of the rail shaft 132, and thus the distal end of the delivery system 10. Furthermore, the proximal end of the rail shaft 132 is connected on the inner surface of the rail housing 202.

[0189] Bending of the rail shaft 132 can be used to position the system, particularly the distal end, at a desired patient location, such as at the native mitral valve. In some embodiments, rotation of the pull wire knobs 206 / 208 can assist in navigating the distal end of the delivery system 10 through the septum and left atrium and into the left ventricle, such that the prosthesis 70 is positioned at the native mitral valve.

[0190] Moving to the delivery housing 204, the proximal ends of the inner shaft assembly 19, the outer sheath assembly 22, the middle shaft assembly 21, and the nosecone shaft assembly 30 can be connected to the inner surface of the delivery housing 204 of the handle 14. Thus, they can be axially moved relative to the rail assembly 20 and the rail housing 202.

[0191] A rotatable outer sheath knob 210 can be located on the distal end of the delivery housing 204, distal to the rail housing 202. Rotation of the outer sheath knob 210 will pull the outer sheath assembly 22 proximally in an axial direction, 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 is translated independently of the other shafts in the delivery system 10. The distal end 303 of the implant 70 can be released first, while the proximal end 301 of the implant 70 can remain radially compressed between the inner retaining member 40 and the outer retaining member 42.

[0192] 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.

[0193] 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 2C The 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.

[0194] 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.

[0195] In some embodiments, handle 14 can provide a lock 218, such as a spring lock, to prevent the nosecone shaft 27 from being translated by the knob 216 discussed above. In some embodiments, the lock 218 can be active at all times, so that the nosecone shaft 27 will not move without the user disengaging the lock 218. The lock can be, for example, a spring lock that is engaged at all times until a button 218 on the handle 14 is pressed, releasing the spring lock and allowing the nosecone shaft 27 to translate proximally / distally. In some embodiments, the spring lock 218 allows one-way motion of the nosecone shaft 27 (proximal motion or distal motion), but prevents motion in the opposite direction.

[0196] Handle 14 can further include a flush port for flushing the different lumens of delivery system 10. In some embodiments, a single flush port on handle 14 can provide fluid connection to multiple components. In some embodiments, the flush port can provide fluid connection to outer sheath assembly 22. In some embodiments, the flush port can provide fluid connection to outer sheath assembly 22 and midshaft assembly 21. In some embodiments, the flush port can provide fluid connection to outer sheath assembly 22, midshaft assembly 21, and rail assembly 20. In some embodiments, the flush port can provide fluid connection to outer sheath assembly 22, midshaft assembly 21, rail assembly 20, and inner assembly 18. Thus, in some embodiments, rail shaft 132, outer retaining ring 42, and capsule body 406 can all be flushed through a single flush port.

[0197] Valve delivery positioning

[0198] A method of using delivery system 10 in conjunction with replacing a mitral valve will now be described. In particular, delivery system 10 can be used in a method of percutaneously delivering a replacement mitral valve to treat a patient suffering from moderate to severe mitral regurgitation. The following method is merely an example of how to use the subject system. It will be understood that the delivery system described herein can also be used as part of other methods.

[0199] As Figure 18 In one embodiment, delivery system 10 can be placed in the ipsilateral femoral vein 1074 and advanced toward the right atrium 1076, as shown in FIG. 107. Transseptal puncture using known techniques can then be performed to access the left atrium 1078. Delivery system 10 can then be advanced into the left atrium 1078 and then into the left ventricle 1080. Figure 18 Delivery system 10 is shown extending from the ipsilateral femoral vein 1074 to the left atrium 1078. In embodiments of the present disclosure, no guide wire is needed to position delivery system 10 in place, but in other embodiments, one or more guide wires can be used.

[0200] Accordingly, it is advantageous for the user to be able to maneuver the delivery system 10 through the complex region of the heart to position the replacement mitral valve in line with the native mitral valve. This task can be performed with the system disclosed above, with or without the use of a guidewire. The distal end of the delivery system can be advanced into the left atrium 1078. The user can then manipulate the rail assembly 20 to target the distal end of the delivery system 10 to the appropriate region. The user can then proceed to pass the curved delivery system 10 through the trans-septal puncture into the left atrium 1078. The user can then further manipulate the delivery system 10 to create more curvature in the rail assembly 20. In addition, the user can twist the entire delivery system 10 to further manipulate and control the position of the delivery system 10. The user can then place the replacement mitral valve in the appropriate position in the fully curved configuration. This can advantageously allow the replacement valve to be delivered to the in situ implantation site, such as the native mitral valve, via a wider variety of paths, such as a trans-septal path.

[0201] The rail assembly 20 is particularly advantageous for accessing the native mitral valve. As discussed above, the rail assembly 20 can form two bends, both of which can be located in the left atrium 1078. The bends in the rail assembly 20 can position the prosthesis 70 located in the implant retention region 16 such that the prosthesis 70 is coaxial with the native mitral valve. Once the prosthesis 70 is coaxial, as discussed below, the outer sheath assembly 22, the midshaft assembly 21, the inner assembly 18, and the nosecone assembly 31 can be advanced distally together relative to the rail assembly 20 (e.g., using the depth knob 212 of the handle 14). These assemblies are constantly pushed away from the rail assembly 20, thereby advancing them coaxially with the native mitral valve until the prosthesis 70 is to be released, while maintaining the prosthesis 70 in a compressed configuration. Thus, the rail assembly 20 provides the user with the ability to lock the angular position in place, so that the user only needs to subsequently advance the other assemblies longitudinally over the rail assembly 20 without any angular changes, greatly simplifying the procedure. The rail assembly 20 acts as a separate steering assembly, where all the assemblies do is provide steerability, and there is no further prosthesis release functionality. Furthermore, the configuration of the rail assembly 20 as described above is sufficiently rigid such that when the rail assembly is actuated to its curved shape, the movement of the other components (e.g., the outer sheath assembly 22, the midshaft assembly 21, the inner assembly 18, and / or the nosecone assembly 31, the rail assembly 20) maintains their shape. Thus, the rail assembly 20 can still be in the desired curved position during the sliding of the other assemblies relative to the rail assembly 20, and the rail assembly 20 can help guide the other assemblies to the final position. The proximal / distal translation of the other assemblies over the rail assembly 20 allows for ventricular atrial motion. Additionally, once the distal anchors 80 of the prosthesis 70 have been released in the left ventricle 1080, but before full release, the other assemblies can be retracted proximally over the rail assembly 20 to capture any leaflets or chordae.

[0202] Reference is now made to Figure 19 which illustrates a schematic view of a portion of an embodiment of a replacement heart valve (prosthesis 70) positioned within the native mitral valve of a heart 83. Further details regarding how the prosthesis 70 can be positioned at the native mitral valve are described in U.S. Publication No. 2015 / 0328000 Al, incorporated by reference herein in its entirety, including but not limited to Figure 13 A-15 and embodiments 28-37. A portion of the native mitral valve, representative of typical anatomical structure, is schematically shown, including the left atrium 1078 located above the annulus 1106 and the left ventricle 1080 located below the annulus 1106. The left atrium 1078 and the left ventricle 1080 communicate with each other through the mitral annulus 1106. In Figure 19The native mitral valve leaflets 1108 are also shown schematically with chordae 1110 connecting the downstream ends of the mitral valve leaflets 1108 to papillary muscles of the left ventricle 1080. The portion of the prosthesis 70 disposed upstream of the annulus 1106 (toward the left atrium 1078) can be referred to as supra-annular. The portion generally within the annulus 1106 is referred to as intra-annular. The portion of the prosthesis 70 downstream of the annulus 1106 is referred to as sub-annular (toward the left ventricle 1080).

[0203] As shown in FIG. 1 1 1, the replacement heart valve (e.g., the prosthesis 70) can be positioned such that the mitral annulus 1106 is between the distal anchor 80 and the proximal anchor 82. In certain instances, the prosthesis 70 can be positioned such that the distal end or tip of the distal anchor 80 contacts the annulus 1106, as shown in FIG. 1 12. In certain instances, the prosthesis 70 can be positioned such that the distal end or tip of the distal anchor 80 does not contact the annulus 1106, as shown in FIG. 1 13. In certain instances, the prosthesis 70 can be positioned such that the distal anchor 80 does not extend around the leaflets 1108, as shown in FIG. 1 14. Figure 19 As shown in FIG. 1 1 1, the replacement heart valve (e.g., the prosthesis 70) can be positioned such that the mitral annulus 1106 is between the distal anchor 80 and the proximal anchor 82. In certain instances, the prosthesis 70 can be positioned such that the distal end or tip of the distal anchor 80 contacts the annulus 1106, as shown in FIG. 1 12. In certain instances, the prosthesis 70 can be positioned such that the distal end or tip of the distal anchor 80 does not contact the annulus 1106, as shown in FIG. 1 13. In certain instances, the prosthesis 70 can be positioned such that the distal anchor 80 does not extend around the leaflets 1108, as shown in FIG. 1 14. Figure 19 As shown in FIG. 1 1 1, the replacement heart valve (e.g., the prosthesis 70) can be positioned such that the mitral annulus 1106 is between the distal anchor 80 and the proximal anchor 82. In certain instances, the prosthesis 70 can be positioned such that the distal end or tip of the distal anchor 80 contacts the annulus 1106, as shown in FIG. 1 12. In certain instances, the prosthesis 70 can be positioned such that the distal end or tip of the distal anchor 80 does not contact the annulus 1106, as shown in FIG. 1 13. In certain instances, the prosthesis 70 can be positioned such that the distal anchor 80 does not extend around the leaflets 1108, as shown in FIG. 1 14.

[0204] As shown in FIG. 1 1 1, the replacement heart valve (e.g., the prosthesis 70) can be positioned such that the mitral annulus 1106 is between the distal anchor 80 and the proximal anchor 82. In certain instances, the prosthesis 70 can be positioned such that the distal end or tip of the distal anchor 80 contacts the annulus 1106, as shown in FIG. 1 12. In certain instances, the prosthesis 70 can be positioned such that the distal end or tip of the distal anchor 80 does not contact the annulus 1106, as shown in FIG. 1 13. In certain instances, the prosthesis 70 can be positioned such that the distal anchor 80 does not extend around the leaflets 1108, as shown in FIG. 1 14. Figure 19 As shown in FIG. 1 1 1, the replacement heart valve (e.g., the prosthesis 70) can be positioned such that the mitral annulus 1106 is between the distal anchor 80 and the proximal anchor 82. In certain instances, the prosthesis 70 can be positioned such that the distal end or tip of the distal anchor 80 contacts the annulus 1106, as shown in FIG. 1 12. In certain instances, the prosthesis 70 can be positioned such that the distal end or tip of the distal anchor 80 does not contact the annulus 1106, as shown in FIG. 1 13. In certain instances, the prosthesis 70 can be positioned such that the distal anchor 80 does not extend around the leaflets 1108, as shown in FIG. 1 14. Figure 19 As shown in FIG. 1 1 1, the replacement heart valve (e.g., the prosthesis 70) can be positioned such that the mitral annulus 1106 is between the distal anchor 80 and the proximal anchor 82. In certain instances, the prosthesis 70 can be positioned such that the distal end or tip of the distal anchor 80 contacts the annulus 1106, as shown in FIG. 1 12. In certain instances, the prosthesis 70 can be positioned such that the distal end or tip of the distal anchor 80 does not contact the annulus 1106, as shown in FIG. 1 13. In certain instances, the prosthesis 70 can be positioned such that the distal anchor 80 does not extend around the leaflets 1108, as shown in FIG. 1 14.

[0205] During delivery, the distal anchors 80 (along with the frame) can be moved toward the ventricular side of the annulus 1106, such as by translating the other components (e.g., the outer sheath component 22, the middle shaft component 21, the inner component 18, and the nosecone component 31) proximally relative to the rail component 20, with the distal anchors 80 extending between at least some of the chordae 1110 to provide a pulling force on the chordae 1110. The degree of pulling force provided on the chordae 1110 can vary. For example, there can be little or no pulling force in the chordae 1110, where the leaflets 1108 are smaller than or approximately the size of the distal anchors 80. There can be a greater degree of pulling force in the chordae 1110, where the leaflets 1108 are longer than the distal anchors 80, thus assuming a compact form and pulling proximally. There can be a greater degree of pulling force in the chordae 1110, where the leaflets 1108 are even longer relative to the distal anchors 80. The leaflets 1108 can be long enough that the distal anchors 80 do not contact the annulus 1106.

[0206] The proximal anchors 82 (if present) can be positioned such that the tips or distal ends of the proximal anchors 82 overhang the annulus 1106 adjacent to the atrial side of the annulus 1106 and / or tissue of the left atrium 1078. In some cases, some or all of the proximal anchors 82 can overhang the annulus 1106 to only occasionally contact or engage the atrial side of the annulus 1106 and / or tissue of the left atrium 1078. For example, as illustrated in the example of FIG. 6, the proximal anchors 82 can overhang the annulus 1106 to be spaced apart from the atrial side of the annulus 1106 and / or tissue of the left atrium 1078. The proximal anchors 82 can provide axial stability to the prosthesis 70. It is also contemplated that some or all of the proximal anchors 82 can overhang the annulus 1106 to contact the atrial side of the annulus 1106 and / or tissue of the left atrium 1078. Figure 19 The proximal anchors 82 (if present) can be positioned such that the tips or distal ends of the proximal anchors 82 overhang the annulus 1106 adjacent to the atrial side of the annulus 1106 and / or tissue of the left atrium 1078. In some cases, some or all of the proximal anchors 82 can overhang the annulus 1106 to only occasionally contact or engage the atrial side of the annulus 1106 and / or tissue of the left atrium 1078. For example, as illustrated in the example of FIG. 6, the proximal anchors 82 can overhang the annulus 1106 to be spaced apart from the atrial side of the annulus 1106 and / or tissue of the left atrium 1078. The proximal anchors 82 can provide axial stability to the prosthesis 70. It is also contemplated that some or all of the proximal anchors 82 can overhang the annulus 1106 to contact the atrial side of the annulus 1106 and / or tissue of the left atrium 1078. Figure 20 A prosthesis 70 implanted in a heart is illustrated. Although the illustrated replacement heart valve includes both proximal and distal anchors, it should be understood that proximal and distal anchors are not required in all cases. For example, a replacement heart valve with only a distal anchor can be able to securely maintain the replacement heart valve in the annulus. This is because the greatest force on the replacement heart valve during systole is directed toward the left atrium. Thus, the distal anchor is most important for anchoring the replacement heart valve in the annulus and preventing migration.

[0207] Delivery method

[0208] Figure 21-23 A release mechanism of the delivery system 10 is illustrated. During initial insertion of the prosthesis 70 and the delivery system 10 into the body, the prosthesis 70 can be located within the system 10, similar to Figure 2AThe distal end 303 of the prosthesis 70, and specifically the distal anchor 80, is constrained within the capsule 106 of the outer sheath assembly 22, preventing expansion of the prosthesis 70. Similar to Figure 2A As shown in FIG. 2, the distal anchor 80 can be extended distally when positioned in the capsule. The proximal end 301 of the prosthesis 70 is constrained within the capsule 106 and within a portion of the inner retaining member 40, and thus is generally constrained between the capsule 106 and the inner retaining member 40.

[0209] Using the steering mechanisms discussed herein or other techniques, the system 10 can first be positioned to a particular location within the patient, such as at the native mitral valve.

[0210] Once the prosthesis 70 is loaded into the delivery system 10, the user can thread a guide wire into the patient to the desired location. The guide wire passes through the lumen of the nosecone assembly 31, so the delivery system 10 can generally be pushed through the patient's body following the guide wire. 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 controlled.

[0211] Once generally within the heart, the user can begin steering the operation of the rail assembly 20 using the distal pull wire knob 206 and / or the proximal pull wire knob 208. By turning either of the knobs, the user can provide a flexing / bending of the rail assembly 20 (at the distal or proximal end), to bend 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 rail assembly 20 to guide the delivery system 10 toward the mitral valve. In particular, the bends of the rail assembly 20 can guide the distal end of the delivery system 10, and thus the capsule 106, along a central axis through the native mitral valve. Thus, when the outer sheath assembly 22, the midshaft assembly 21, the inner assembly 18, and the nosecone assembly 31 are advanced together over the rail assembly 20 with the prosthesis 70 compressed, the capsule 106 travels directly into alignment with the axis for proper release of the prosthesis 70.

[0212] The user can also rotate and / or move the handle 14 itself in the stand to further tune the distal end of the delivery system 10. The user can continuously turn the proximal pull wire knob 208 and / or the distal pull wire knob 206, as well as move the handle 14 itself, to orient the delivery system 10 to release the prosthesis 70 into the body. The user can also further move other assemblies relative to the rail assembly 20, such as proximally or distally.

[0213] 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.

[0214] 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.

[0215] 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.

[0216] During this step, system 10 can be moved proximally or distally to properly capture the native mitral valve leaflets by distal or ventricular anchors 80. This can be accomplished by moving outer sheath assembly 22, central shaft assembly 21, inner assembly 18, and nosecone assembly 31 relative to track assembly 20. In particular, the tips of ventricular anchors 80 can be moved proximally to engage the ventricular side of the native annulus such that the native leaflets are positioned between anchors 80 and the body of prosthesis 70. When prosthesis 70 is in its final position, there can or can not be tension on the chordae, although distal anchors 80 can be positioned between at least some of the chordae.

[0217] After capsule 106 is retracted, the proximal end 301 of prosthesis 70 will still be in outer retaining ring 42. As shown in FIG. 6B, once distal end 303 of prosthesis 70 is fully expanded (or as fully expanded as possible at this time), outer retaining ring 42 can be individually withdrawn proximally relative to the other assemblies (particularly relative to inner assembly 18) to expose inner retaining member 40, thereby initiating expansion of proximal end 301 of prosthesis 70. For example, in a mitral valve replacement procedure, after distal or ventricular anchors 80 are positioned between at least some of the chordae and / or engage the native mitral annulus, proximal end 301 of prosthesis 70 can be expanded in the left atrium. Figure 22

[0218] Outer retaining ring 42 can be moved proximally so that proximal end 310 of prosthesis 70 can be radially expanded to its fully expanded configuration, as shown in FIG. 6C. After prosthesis 70 is expanded and released, inner assembly 18, nosecone assembly 31, central shaft assembly 21, and outer sheath assembly 22 can be simultaneously withdrawn proximally along or relative to track assembly 20 to their original positions. In some embodiments, they are not withdrawn relative to track assembly 20, but remain in the expanded position. Furthermore, nosecone 28 can be withdrawn through the center of expanded prosthesis 70 and into outer sheath assembly 22, such as by translating knob 216 proximally. System 10 can then be removed from the patient. Figure 23

[0219] Figure 24A -B illustrates the advancement of the different assemblies over track assembly 20. Figure 24A illustrates the assemblies in their most proximal position over track assembly 20. Figure 24B illustrates the assemblies in their most distal position compared to track assembly 20, as shown in FIG. 6A. Thus, the assemblies are tortuous along track assembly 20 and extend distally. Figure 2C

[0220] In some embodiments, prosthesis 70 can be delivered under fluoroscopy so that the user can observe certain reference points to properly position prosthesis 70. Furthermore, echocardiography can be used to properly position prosthesis 70. ​​​

[0221] The following is a discussion of an alternative implantation method for delivering a replacement mitral valve to a mitral valve site. Elements from below can be incorporated into the above discussion, and vice versa. Prior to insertion of the delivery system 10, the access site into the patient can be dilated. In addition, the dilator can be flushed with, for example, heparinized saline prior to use. The delivery system 10 can then be inserted over a guide wire. In some embodiments, any flush ports on the delivery system 10 can be directed vertically. In addition, if a guide catheter is used (in an integrated manner or otherwise), this guide catheter 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 into 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 a desired position, such as under fluoroscopy. The track can be flexed so that the distal end of the delivery system 10 can be directed toward the septum and the mitral valve. The position of the delivery system 10 and the prosthetic 70 inside can be verified using echocardiography and fluoroscopy guidance.

[0222] In some embodiments, the prosthetic 70 can be located above the mitral annulus 1106, aligned with the mitral annulus 1106, or below the mitral annulus 1106 prior to release. In some embodiments, the prosthetic 70 can be located completely above the mitral annulus 1106, aligned with the mitral annulus 1106, just below the mitral annulus 1106 (just below), or completely below the mitral annulus 1106 prior to expansion. In some embodiments, the prosthetic 70 can be located partially above the mitral annulus 1106, aligned with the mitral annulus 1106, or partially below the mitral annulus 1106 prior to expansion. In some embodiments, a pigtail catheter can be introduced into the heart to perform a ventriculogram for proper visualization.

[0223] In some embodiments, the location of the mitral valve plane and the height of any papillary muscles can be marked on a fluoroscopy monitor to indicate an example target landing zone. If needed, the delivery system 10 can be unflexed, rotationally reduced, and retracted to reduce the pull on the delivery system 10, as well as to reduce contact with the left ventricular wall, the left atrial wall, and / or the mitral annulus 1106.

[0224] Further, the delivery system 10 can be positioned coaxial with the mitral annulus 1106, or at least as coaxial as possible, while still reducing contact with the left ventricular wall, the left atrial wall, and / or the mitral annulus 1106 and reducing pull on the delivery system. An echo probe can be placed to visualize the anterior mitral leaflet (AML), the posterior mitral leaflet (PML) (the leaflets 1108), the mitral annulus 1106, and the outflow tract. Fluoroscopy and echocardiography can be used to confirm the positioning of the prosthesis 1010 at a particular depth and coaxiality with the mitral annulus 1106.

[0225] Afterwards, the outer sheath assembly 22 can be retracted to expose the ventricular anchors 80, releasing them. In some embodiments, once exposed, the outer sheath assembly 22 can be reversed in direction to reduce the pull on the outer sheath assembly 22. In some embodiments, reversing the direction can also be used to partially or completely capture the prosthesis 70.

[0226] The distal anchors 80 can be released in the left atrium 1078. Further, the proximal anchors 82 (if included in the prosthesis 70) have not yet been exposed. Additionally, at this point the main body of the prosthesis 70 has not yet undergone any expansion. However, in some embodiments, one or more of the distal anchors 80 can be released in the left atrium 1078 (e.g., above the annulus), or released approximately aligned with the mitral annulus 1106 (e.g., within the annulus), or released just below the mitral annulus 1106 (e.g., below the annulus). In some embodiments, all of the distal anchors 80 can be released together. In other embodiments, one subset of the distal anchors 80 can be released while in a first position, while another subset of the distal anchors 80 can be released while in a second position. For example, some of the distal anchors 80 can be released in the left atrium 1078, while some of the distal anchors 80 can be released approximately aligned with the mitral annulus 1106 or just below the mitral annulus 1106.

[0227] If the distal anchors 80 are released "just below" the mitral annulus 1106, they can be released 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 anchors 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 can allow the distal anchors 80 to zigzag through the chordae when making a sharp turn down towards the mitral valve. This can advantageously allow the prosthesis 70 to slightly contract. In some embodiments, this can eliminate the need for a secondary crossing wire across the mitral valve. In some embodiments, the crossing wire can be withdrawn into the delivery system 10 before or after the distal anchors 80 are released.

[0228] In some embodiments, the distal anchors 80 can be released immediately after crossing the septum, and then the final trajectory of the delivery system 10 can be determined. Thus, the delivery system 10 can cross the septum, release the ventricular anchors 80, establish a trajectory, and move into the left ventricle to capture the leaflets.

[0229] As discussed in detail above, upon release from the delivery system 10, the distal anchors 80 can flip from extending distally to extending proximally. This flip is approximately 180°. Thus, in some embodiments, the distal anchors 80 can flip in the left atrium 1078 (e.g., over-the-ring flip), flip approximately in line with the mitral annulus 1106 (e.g., in-the-ring flip), or flip directly below the mitral annulus 1106 (e.g., under-the-ring flip). The proximal anchors 82, if any, can still be within the delivery system 10. In some embodiments, all of the distal anchors 80 can flip together. In other embodiments, a subset of the distal anchors 80 can flip while in a first position, while another subset of the distal anchors 80 can release while in a second position. For example, some of the distal anchors 80 can flip in the left atrium 1078, while some of the distal anchors 80 can flip approximately in line with or directly below the mitral annulus 1106.

[0230] In some embodiments, in the non-flipped position, the distal anchors 80 can be positioned in line with or directly below the annulus 1106. In some embodiments, in the flipped position, the distal anchors 80 can be positioned in line with or directly below the annulus 1106. In some embodiments, the distal-most portion of the flipper prosthesis 70 can be positioned within or below the mitral annulus 1106, such as directly below the mitral annulus 1106, prior to flipping the distal-most portion. However, flipping the anchors without any other movement of the delivery system 10 can cause the distal-most portion of the prosthesis 70 / anchors 80 to move upward, either into the left atrium 1078 or into line with the mitral annulus 1106. Thus, in some embodiments, the distal anchors 80 can begin to flip at the annulus 1106, but end up entirely within the left atrium 1078 after flipping. In some embodiments, the distal anchors 80 can begin to flip below the annulus 1106, but end up entirely within the annulus 1106 after flipping.

[0231] In some embodiments, the distal anchor 80 can be proximal to the free edge of the mitral valve leaflet 1108 (e.g., toward the left atrium 1078) after release and flipping. In some embodiments, the distal anchor 80 can be aligned with the free edge of the mitral valve leaflet 1108 (e.g., toward the left atrium 1078) after release and flipping. In some embodiments, the distal anchor 80 can be proximal to the free edge of the mitral annulus 1106 (e.g., toward the left atrium 1078) after release and flipping. In some embodiments, the distal anchor 80 can be aligned with the free edge of the mitral annulus 1106 (e.g., toward the left atrium 1078) after release and flipping.

[0232] Thus, in some embodiments, the distal anchor 80 can be released / flipped above where chordae 1110 attach to the free edge of the native leaflet 1108. In some embodiments, the distal anchor 80 can be released / flipped above where certain chordae 1110 attach to the free edge of the native leaflet 1108. In some embodiments, the distal anchor 80 can be released / flipped above where all chordae 1110 attach to the free edge of the native leaflet 1108. In some embodiments, the distal anchor 80 can be released / flipped above the mitral annulus 1106. In some embodiments, the distal anchor 80 can be released / flipped above the mitral valve leaflet 1108. In some embodiments, the distal anchor 80 can be released / flipped approximately in line with the mitral annulus 1106. In some embodiments, the distal anchor 80 can be released / flipped approximately in line with the mitral valve leaflet 1108. In some embodiments, the tip of the distal anchor 80 can be released / flipped approximately in line with the mitral annulus 1106. In some embodiments, the tip of the distal anchor 80 can be released / flipped approximately in line with the mitral valve leaflet 1108. In some embodiments, the distal anchor 80 can be released / flipped below where certain chordae 1110 attach to the free edge of the native leaflet 1108. In some embodiments, the distal anchor 80 can be released / flipped below where all chordae 1110 attach to the free edge of the native leaflet 1108. In some embodiments, the distal anchor 80 can be released / flipped below the mitral annulus 1106. In some embodiments, the distal anchor 1024 can be released / flipped below the mitral valve leaflet 1108.

[0233] Once the distal anchor 80 is released and flipped, the delivery system 10 can be translated through the mitral valve annulus 1106, toward the left ventricle 1080, such that the distal anchor 80 enters the left ventricle 1080. In some embodiments, the distal anchor 80 can be compressed as it passes through the mitral valve annulus 1106. In some embodiments, the prosthesis 70 can be compressed as it passes through the mitral valve annulus 1106. In some embodiments, the prosthesis 70 is not compressed as it passes through the mitral valve annulus 1106. The distal anchor 80 can be delivered anywhere between the leaflets 1108 and the papillary heads in the left ventricle 1080.

[0234] In some embodiments, the distal anchor 80 is fully expanded prior to passing through the mitral valve annulus 1106. In some embodiments, the distal anchor 80 is partially expanded prior to passing through the mitral valve annulus 1106, and continued operation of the delivery system 10 can cause the distal anchor 80 to fully expand in the left ventricle 1080.

[0235] As the distal anchor 80 enters the left ventricle 1080, the distal anchor 80 can pass through the chordae 1110 and move behind the mitral valve leaflets 1108, thereby capturing the leaflets 1108. In some embodiments, the distal anchor 80 and / or other portions of the prosthesis 1010 can push the chordae 1110 and / or the mitral valve leaflets 1108 outward.

[0236] Accordingly, after the distal anchor 80 is released, the delivery system 10 can then be repositioned as necessary so that the remaining end of the distal anchor 80 is at the same level as the free edge of the native mitral valve leaflets 1108. If possible, the delivery system 10 can also be positioned coaxially with the mitral valve annulus 1106 while still reducing contact with the left ventricular wall, the left atrial wall, and / or the annulus 1106.

[0237] In some embodiments, only the distal anchor 80 is released in 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 can be further expanded in the left atrium 1078. Accordingly, instead of the distal anchor 80 being flipped and the body of the prosthesis 70 not having any portion expanded, a portion of the prosthesis 70 can be exposed and allowed to expand in the left atrium 1078. This partially exposed prosthesis 1010 can then pass through the annulus 1106 into the left ventricle 1080. In addition, the proximal anchor, if any, can be exposed. In some embodiments, the entirety of the prosthesis 70 can be expanded within the left atrium 1078.

[0238] To facilitate passage through the annulus 1106, the delivery system 10 can include a leader element (not shown) that passes through the annulus 1106 prior to passage of the prosthesis 70 through the annulus 1106. For example, the leader element can include an expandable member, such as an expandable balloon, that can help maintain the shape of the annulus 1106 or expand it. The leader element can have a conical or rounded shape (e.g., a cone, a truncated cone, a hemisphere) to facilitate positioning through the annulus 1106 and expansion of the annulus 1106. In some embodiments, the delivery system 10 can include an engagement element (not shown) that can exert a force on the prosthesis 70 to force the prosthesis 70 through the annulus 1106. For example, the engagement element can include an expandable member, such as an expandable balloon, positioned within or above the prosthesis 70.

[0239] In some embodiments, to facilitate passage through the annulus 1106, the user can re-orient the prosthesis 70 prior to passing the prosthesis 70 through the annulus 1106. For example, the user can re-orient the prosthesis 70 so that the prosthesis 70 passes through the annulus 1106 sideways.

[0240] However, if only the distal anchor 80 is flipped over and no other expansion occurs, the prosthesis can partially expand in the ventricle 1080. Thus, distal expansion can be allowed to capture the leaflets 1108 when the prosthesis 70 is in the proper position. If the distal end has already expanded, no further expansion occurs, or the distal end can further expand.

[0241] 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 needed to capture the leaflets 1106, the outer sheath assembly 22 can be retracted until the desired diameter of the prosthesis 70 is reached. Capture of the leaflets 1106 can be confirmed by echogenic imaging. In some embodiments, the user can confirm that the prosthesis 70 is still at the proper depth and has not advanced into the left ventricle 1080. The position can be adjusted as needed.

[0242] In some embodiments, once the distal anchor 80 enters the left ventricle 1080, the system 10 can be pulled back (e.g., toward the left atrium 1078) to fully capture the leaflets 1108. In some embodiments, the system 10 need not be pulled back to capture the leaflets 1108. In some embodiments, the systolic pressure can push the leaflets 1108 up to be captured by the distal anchor 80. In some embodiments, the systolic pressure can push the entire prosthesis 70 up toward the mitral annulus 1106 after the leaflets 1108 are captured and the prosthesis 70 is fully or partially released. In some embodiments, the user can rotate the delivery system 10 and / or the prosthesis 70 prior to and / or concurrently with pulling the delivery system 10 back. In some cases, this can beneficially engage a greater number of chordae tendinae.

[0243] 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 height relative to the mitral annulus 1106, such as by flexing, translating, or rotating the delivery system 10. The prosthesis 70 can be repositioned as needed to capture the free edges of the native mitral valve leaflets 1108. Once the leaflets 1108 are confirmed to be fully engaged, the prosthesis 70 can be set perpendicular (or approximately perpendicular) to the mitral annulus plane.

[0244] Subsequently, the central shaft assembly 21 can be withdrawn. The direction of the central shaft assembly 21 can then be reversed to relieve any tension on the delivery system 10.

[0245] The following is a discussion of proximal anchors 82, although some embodiments of the prosthesis 70 can not include them. In some embodiments, the proximal anchors 82 can not be released from the system 10 until the distal anchors 80 have captured the leaflets 1108. In some embodiments, the proximal anchors 82 can be released from the system 10 before the distal anchors 80 capture the leaflets 1108. In some embodiments, the proximal anchors 82 can be released while the expanded prosthesis 70 (partially or fully expanded) can be translated through the mitral annulus 1106 when the distal anchors 80 are above or within the annulus. In some embodiments, the proximal anchors 82 can be released while the entire prosthesis 70 can be pulled up into the left atrium 1078 so that the proximal anchors 82 are above the annulus before release when the distal anchors 80 are below the annulus. In some embodiments, the proximal anchors 82 can be within the annulus before release, and the systolic pressure can push the prosthesis 70 into the atrium so that the proximal anchors 82 end up above the annulus.

[0246] Thereafter, leaflet capture and positioning of the prosthesis 70, along with the relatively perpendicular position relative to the mitral annulus plane, can be confirmed. In some embodiments, the nosecone 28 can then be withdrawn until it is within the prosthesis 70. The central shaft 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 fluoroscopic imaging.

[0247] Subsequently, the delivery system 10 can be centered within the prosthesis 70. The nosecone 28 and delivery system 10 can then be retracted into the left atrium 1078 and removed.

[0248] This intra-annulus over-annulus release can have a number of advantages. For example, it allows the distal anchors 82 to properly align when contacting the chordae 1110. If the distal anchors 82 were released in the left ventricle 1080, this can result in misalignment or damage to heart tissue, such as the leaflets 1108 or chordae 1110.

[0249] 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.

[0250] Optional delivery system

[0251] 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'.

[0252] 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.

[0253] like Figure 26AAs shown in the cross-sectional view of B, the distal end of the delivery system 10' can include one or more subassemblies, such as an outer shaft assembly 12', an inner shaft assembly 18', a rail assembly 20', and a nosecone assembly 31', as will be described in greater detail below.

[0254] In particular, embodiments of the disclosed delivery system can utilize a steerable rail in the rail assembly 20' to steer the distal end of the delivery system 10', thereby allowing the implant to be properly positioned within the patient. Similar to the rail assemblies described above, the steerable rail can be, for example, a rail shaft that extends generally from the handle through the delivery system 10' to the distal end. A user can steer the bends of the distal end of the rail, thereby bending the rail in a particular direction. In some embodiments, the rail can have more than one bend along its length, thereby providing multiple bending directions. When the rail is bent, it can press against other assemblies, bending them as well, and thus the other assemblies of the delivery system 10' can be configured to steer with the rail, thereby providing full steerability of the distal end of the delivery system. Once the rail is steered into a particular position within the patient, the prosthesis 70 can be advanced along the rail and released into the body.

[0255] Beginning with the outermost assembly, the delivery system can include an outer sheath assembly 22' that forms a radial outer covering or sheath to hold the implant retention region 16' and prevent radial expansion of the implant. Moving radially inward, the inner shaft assembly 18' can consist of an inner shaft that has its distal end attached to an inner retention member or inner retention ring 40' for axially retaining the prosthesis. The inner shaft assembly 18' can be located within the lumen of the outer sheath assembly 22'. Moving further inward, the rail assembly 20' can be configured for steering, as described above and further below. The rail assembly 20' can be located within the lumen of the inner shaft assembly 18'. Further, the most radially inward assembly is the nosecone assembly 31', which includes a nosecone shaft 27' that has its distal end connected to a nosecone 28'. The nosecone assembly 31' can be located within the lumen of the rail shaft assembly 20'. The nosecone assembly 31' can include a lumen for a guidewire to pass through.

[0256] The shaft assembly 12', and more specifically the nosecone assembly 31', the inner assembly 18', the rail assembly 20', and the outer sheath assembly 22', can be collectively configured to advance the prosthesis 70 within the implant retention region 16' (e.g., the lumen of the inner shaft assembly 18') from the handle 14' to the distal end of the delivery system 10' (e.g., the nosecone 28') in response to a user's manipulation of the handle 14'. Figure 26AThe prosthesis 70 can then be moved to a treatment location. One or more subassemblies can then be moved to allow the prosthesis 70 to be released at the treatment location. For example, one or more subassemblies can be moved relative to one or more other subassemblies. The handle 14' can include various control mechanisms that can be used to control movement of the various subassemblies, which will also be described in more detail below. In this manner, the prosthesis 70 can be controllably loaded onto the delivery system 10' and then later deployed inside the body. In addition, the handle 14' can provide steering to the track assembly 20' to provide bending / flexing / steering to the distal end of the delivery system 10'.

[0257] As will be discussed below, the inner retaining member 40' and the outer sheath assembly 22' can cooperate to retain the prosthesis 70 in a compact configuration. The inner retaining member 40' can be positioned within the outer sheath assembly 22' such that 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 retaining member 40'. Figure 26A As shown in FIGS. 26A and 26B, the inner retaining member 40' is shown engaging the struts 72 at the proximal end 301 of the prosthesis 70. For example, the slots between the radially extending teeth located on the inner retaining member 40' can receive and engage the struts 72, which can terminate in mushroom-shaped protrusions 74 on the proximal end of the prosthesis 70. The outer sheath assembly 22' can be positioned over the inner retaining member 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 retaining member 40'.

[0258] As shown in FIGS. 26A and 26B, the inner retaining member 40' is shown engaging the struts 72 at the proximal end 301 of the prosthesis 70. For example, the slots between the radially extending teeth located on the inner retaining member 40' can receive and engage the struts 72, which can terminate in mushroom-shaped protrusions 74 on the proximal end of the prosthesis 70. The outer sheath assembly 22' can be positioned over the inner retaining member 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 retaining member 40'. Figure 26A As shown in FIGS. 26A and 26B, the inner retaining member 40' is shown engaging the struts 72 at the proximal end 301 of the prosthesis 70. For example, the slots between the radially extending teeth located on the inner retaining member 40' can receive and engage the struts 72, which can terminate in mushroom-shaped protrusions 74 on the proximal end of the prosthesis 70. The outer sheath assembly 22' can be positioned over the inner retaining member 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 retaining member 40'. 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 can be held to point generally proximally in the delivery configuration and compressed against the body of the prosthesis frame.

[0259] The delivery system 10' with the pre-installed prosthesis 70 can be provided to the user. In other embodiments, the prosthesis 70 can be loaded onto the delivery system shortly before use, such as by a physician or nurse.

[0260] As shown in FIG. 26B, there can be no additional layers / shafts / members between the inner retaining member 40' and the outer sheath assembly 22'. By not having such a shaft, the overall diameter of the delivery system 10' can be reduced.

[0261] However, in some embodiments, an outer retaining member (or ring) 42' can be incorporated into the delivery system 10', as shown in FIG. 26C. The outer retaining member 42' can be positioned over the inner retaining member 40' and the outer sheath assembly 22' 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 retaining member 42', the outer sheath assembly 22', and the inner retaining member 40'. 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.

[0262] 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.

[0263] Delivery system components

[0264] Figure 27-29 Another view of the delivery system 10' is shown, in which the different components are panned proximally and described in detail.

[0265] 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 sub-tube 104' attached to its distal end. The capsule body 106' may then be attached substantially to the distal end of the outer sub-tube 104'. These components of the outer sheath assembly 22' may form cavities to allow other sub-assemblies to pass through.

[0266] 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.

[0267] Capsule 106' can be a tube formed of a plastic or metallic material. In some embodiments, capsule 106' is formed of ePTFE or PTFE. In some embodiments, capsule 106' can be relatively thick to prevent tearing and to help maintain the self-expanding implant in a compact configuration. In some embodiments, the material of capsule 106' is the same as the material of the coating on outer hypotube 104'. As shown, capsule 106' can have a larger diameter than outer hypotube 104', although in some embodiments, capsule 106' can have a similar diameter as hypotube 104'. Capsule 106' can be configured to hold prosthesis 70 within capsule 106' in a compressed position.

[0268] Outer sheath assembly 22' is arranged to slide over inner assembly 18', track assembly 20', and nosecone assembly 31'.

[0269] Moving radially inward, the next assembly is inner shaft assembly 18'. Figure 28 The same view is shown as Figure 27 The same view is shown as

[0270] Inner shaft assembly 18' can include an inner shaft 122' attached at its proximal end to handle 14', and an inner retention ring 40' at the distal end of inner shaft 122'. Inner shaft 122' can itself be composed of an inner proximal shaft 124' attached directly at its proximal end to handle 14', and an inner hypotube 126' attached to the distal end of inner proximal shaft 124'. Thus, inner retention ring 40' can be attached at the distal end of inner hypotube 126'. These components of inner shaft assembly 18' can form a lumen for passage of other subassemblies.

[0271] Similar to other assemblies, inner proximal shaft 124' can include a tube, such as a hypotube or a subcutaneous tube (not shown). The tube can be made of one of a variety of different materials, including nitinol, stainless steel, and medical grade plastic. The tube can be a single piece tube or a multi-piece tube that is connected together. Use of a tube made of multiple pieces can allow the tube to provide different properties, such as rigidity and flexibility, along different sections of the tube. Inner hypotube 126' can be a metallic hypotube, which in some embodiments, can be cut or have slots, as discussed in detail below. Tube 126' can be covered or encapsulated by a layer of ePTFE, PTFE, or other material, such that the outer surface of inner hypotube 126' is generally smooth.

[0272] Inner retention member 40' can be configured as a prosthesis retention mechanism, such as with respect to 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'.

[0273] The inner shaft assembly 18' is arranged to slide above the track assembly 20' and the nose cone assembly 31'.

[0274] 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.

[0275] 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.

[0276] 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'.

[0277] The distal pull wire 138' can be connected (alone or through a connector) approximately at the distal end of the rail hypotube 136'. The proximal pull wire 140' can be connected at a location along the length of the rail hypotube 136' that is approximately one quarter, one third, or one half from the proximal end. In some embodiments, the distal pull wire 138' can pass through a small diameter pull wire lumen attached to the inside of the rail hypotube 136'. In some embodiments, the distal pull wire 138' can pass through a small diameter coil and / or hypotube to provide independent steering. The small diameter coil and / or hypotube can be attached to the inside of the rail hypotube 136', which allows for independent steering and flexibility in the shaft. This can prevent the pull wire 138' from pulling the rail hypotube 136' at the location of the distal connection. In some embodiments, these lumens can be attached to the outer surface of the nosecone shaft 31', distal to the location where the proximal pull wire 140' is attached to the rail hypotube 136'.

[0278] For pairs of proximal pull wires 140', the wires can be spaced approximately 180° from each other to allow steering in two directions. Similarly, for pairs of distal pull wires 138', the wires can be spaced approximately 180° from each other to allow steering in two directions. In some embodiments, pairs of distal pull wires 138' and pairs of proximal pull wires 140' can be spaced approximately 90° from each other. In some embodiments, pairs of distal pull wires 138' and pairs of proximal pull wires 140' can be spaced approximately 0° from each other. However, other positions of the pull wires can also be used, and the specific position of the pull wires is not limited.

[0279] The rail assembly 20' is arranged so that it can slide over the nosecone assembly 31'.

[0280] Further inward from the rail assembly is the nosecone assembly 31', also shown in Figure 29 This can be a nosecone shaft 27', and in some embodiments can have a nosecone 28' on its distal end. The nosecone 28' can be made of polyurethane for atraumatic access and to minimize damage to the venous vasculature. The nosecone 28' can also be radiopaque to provide visibility under fluoroscopy.

[0281] The nosecone shaft 27' can include a lumen sized and configured to slidably receive a guidewire so that the delivery system 10' can be advanced over the guidewire through the vasculature. However, embodiments of the system 10' discussed herein can not use a guidewire, so the nosecone shaft 27' can be solid. The nosecone shaft 27' can be connected from the nosecone 28' to a handle, or can be formed from different parts such as other assemblies. Furthermore, the nosecone shaft 27' can be formed from different materials (such as plastic or metal) similar to the materials described in detail above.

[0282] In some embodiments, one or more spacer sleeves (not shown) can be used between different components of delivery system 10'. For example, a first spacer sleeve can be concentrically positioned between inner shaft assembly 18' and rail assembly 20', generally between inner hypotube 126' / rail hypotube 136'. A second spacer sleeve can be concentrically positioned between rail assembly 20' and nosecone assembly 31', generally longitudinally within rail hypotube 136'. The spacer sleeves can be made of a polymeric material, such as braided Pebax®, and can be lined on the inner diameter with, for example, PTFE, although the particular material is not limiting. The spacer sleeves can advantageously reduce friction between steerable rail assembly 20' and its surrounding components. Thus, the spacer sleeves can act as a buffer between rail assembly 20' and inner assembly 18' / nosecone assembly 30'. Further, the spacer sleeves can occupy any radial gap between the components, preventing the components from being compressed or kinked during steering.

[0283] The spacer sleeves can be mechanically housed by other lumens and components, and thus non-physically attached to any other components, allowing the spacer sleeves to "float" in that area. The floating aspect of the spacer sleeves allows them to move where they are needed during deflection, and provide a bearing surface(s) for support and / or lubrication. Thus, the floating aspect allows delivery system 10' to maintain a flexing force. However, in some embodiments, the spacer sleeves can be connected to other components.

[0284] Hypobo tube construction

[0285] As discussed above, outer sheath assembly 22', inner assembly 18', and rail assembly 20' can include outer hypotube 104', inner hypotube 126', and rail hypotube 136', respectively. Each of these hypotubes can be laser cut to include a plurality of slots, establishing a curved pathway for the delivery system. Although different slot assemblies are discussed below, it should be understood that any of the three hypotubes can have any of the slot configurations discussed below. Figure 30-32 The different hypotubes are shown in isolation.

[0286] Figure 30 Outer hypotube 104' (distal end facing right) shown in FIG. 4 can include a plurality of slots 103' transverse to its lumen along a majority of the length of outer hypotube 104'. Each of the slots can extend almost entirely around the circumference of outer hypotube 104', forming a single ridge 105' of material extending between the proximal and distal ends of outer hypotube 104'. In some embodiments, outer hypotube 104' can include more than one ridge. As shown, the slots can extend generally from the proximal end of outer hypotube 104' to the distal end of hypotube 104', allowing the entirety of outer hypotube 104' to more easily bend with rail assembly 20'.

[0287] As shown, the spine 105' can rotate circumferentially while advancing from the proximal end to the distal end of the outer waveguide 104'. For example, the distal end of the spine 105' can be offset from the proximal end of the spine 105' by about 30°, 45°, 90°, 135°, or 180°. In some embodiments, the spine 105' is still in the same circumferential position from the proximal end to about half the length of the outer waveguide 104'. At this point, the spine 105' can begin to rotate circumferentially around the outer waveguide 104'. The curvature of the spine helps to guide the outer waveguide 105 during steering of the rail assembly 20'. As the outer waveguide 105 is guided into the heart and toward the mitral valve, the spine 105' generally follows the typical curvature formed by the rail assembly 20', thereby mitigating some of the forces that can occur if the spine 105' were straight. However, in some embodiments, the spine 105' of the outer waveguide 104' can be straight, and the specific configuration of the spine is not limited.

[0288] moves radially inward, Figure 31 In some embodiments, the inner waveguide 126' also contains a plurality of slots 1402' (distal end facing right). However, unlike the outer waveguide 104', in some embodiments, the inner waveguide 126' does not contain slots along most of its length 1400', but in some embodiments, the inner waveguide 126' can contain slots. This allows the inner waveguide 126' to be more rigid, as the inner waveguide 126' will experience a large amount of compression, and the spiral spine would prevent coiling. Additionally, as described below, this allows the inner assembly 18' to guide other assemblies to extend straight when advancing over the rail assembly 20'.

[0289] The inner waveguide 126' can contain slots generally from the distal end, along 1⁄4, 1⁄3, or 1⁄2 of its distal length, transverse to its lumen axis. In some embodiments, unlike the single spine of the outer waveguide 104', each circumferential position can have two slots with a span of less than 180°, thereby forming two spines 127' in the inner waveguide. These spines 127' can be spaced apart by about 180°, but in some embodiments different angles can be used depending on the desired curvature. However, in some embodiments, a single spine or more than two spines can be used. Additional spines can provide additional rigidity to the inner assembly 18'.

[0290] In some embodiments, the inner hypotube 126' can include a single slot pattern that forms a double ridge as discussed above. In some embodiments, the inner hypotube 126' can include two different slot patterns. For example, at the distal-most end, the slots can be configured in only one direction of curvature (e.g., only in the X-axis), making this section both strong and robust, yet less flexible. However, the slots in the proximal section can be configured to include multiple axes of curvature (e.g., the X-axis and the Y-axis), making the inner hypotube 126' more flexible for steering. In some embodiments, the configuration of the inner hypotube 126' creates a force that wants to extend straight (e.g., not curved). Thus, when the inner hypotube 126' is advanced over the rail hypotube 136', it will achieve a straight configuration.

[0291] Next, moving radially inward again, Figure 32 An embodiment of the rail hypotube 136' is shown (distal end facing right). The rail hypotube 136' can also include a plurality of transverse slots. The rail hypotube can generally be divided into a plurality of different sections. At the proximal-most end is an uncut (or unslotted) hypotube section 131'. This can occupy about one quarter to one third of the rail hypotube 136'. Moving distally, the next section is a proximally slotted hypotube section 133'. This section includes a plurality of transverse slots cut into the rail hypotube. In general, two slots are cut around each circumferential location, forming almost half of the circumference. Thus, two stems are formed between these slots that extend along the length of the rail hypotube 136'. This is the section that can be guided by the proximal pull wire 140'. Further distally is the location 137' where the proximal pull wire 140' connects, thus avoiding slotted. This section is just distal to the proximally slotted section.

[0292] Distally, behind the proximal pull wire connection area is a distally slotted hypotube section 135'. This section is similar to the proximally slotted hypotube section 133', but with significantly more slots cut in equal length. Thus, the distally slotted hypotube section 135' provides for easier bending than the proximally slotted hypotube section 133'. In some embodiments, the proximally slotted section 133' can be configured to undergo about 90 degrees of bending at a half inch radius, while the distally slotted section 135' can bend at about 180 degrees within a half inch. Also, as shown in FIG. 6B, the ridges of the distally slotted hypotube section 135' are offset from the ridges of the proximally slotted hypotube section 133'. Thus, the two sections will achieve different bending patterns, allowing for three-dimensional manipulation of the rail assembly 20'. In some embodiments, while the specific offset is not limited, the ridges can be offset by 30 degrees, 45 degrees, or 90 degrees. Figure 32

[0293] ​At the distal-most end of the distally slotted hypotube section 135' is a distal pull wire connection region 139', again a non-slotted section of the rail hypotube 136'.

[0294] handle

[0295] The handle 14' is at the proximal end of the delivery system 10' and as shown in Figure 33 FIG. 1. It can include a plurality of 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.

[0296] The handle 14' is generally comprised of two housings - a rail housing 202' and a delivery housing 204', with the rail housing 204' disposed circumferentially around the delivery housing 204'. The inner surface of the rail housing 202 can include a threadable section configured to mate 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., thread) within the rail housing 202'. The rail housing 202' generally surrounds about half the length of the delivery housing 204', so the delivery housing 204' extends outside of the rail housing 202' both proximally and distally.

[0297] The rail housing 202' can contain two rotatable knobs - a distal pull wire knob 206' and a proximal pull wire knob 208'. However, the number of rotatable knobs on the rail housing 202' can vary depending on the number of pull wires used. Rotation of the distal pull wire knob 206' can provide a proximal force, thereby providing an axial pulling force on the distal pull wire 138' and causing the distally slotted section 135' of the rail hypotube 136' to bend. The distal pull wire knob 206' can be rotated in either direction, thereby allowing bending in either direction. Rotation of the proximal pull wire knob 208' can provide a proximal force on the proximal pull wire 140' and thus an axial pulling force, thereby causing the proximally slotted section 133' of the rail hypotube 136' to bend. The proximal pull wire knob 108' can be rotated in either direction, thereby allowing bending in either direction. Thus, when both knobs are actuated, there can be two bends in the rail hypotube 136', allowing for three-dimensional manipulation of the rail shaft 132' and thus the distal end of the delivery system 10'. Furthermore, the proximal end of the rail shaft 132' is connected on the inner surface of the rail housing 202'.

[0298] Bending of the rail shaft 132' can be used to position the system, particularly the distal end, at a desired patient location, such as at the native mitral valve. In some embodiments, rotation of the pull wire knobs 206' / 208' can assist in navigating the distal end of the delivery system 10' through the septum and left atrium and into the left ventricle, such that the prosthesis 70 is positioned at the native mitral valve.

[0299] Moving to the delivery housing 204', the proximal ends of the inner shaft assembly 19', the outer sheath assembly 22', and the nosecone shaft assembly 30' can be connected to the inner surface of the delivery housing 204 of the handle 14'. Thus, they can be moved axially relative to the rail assembly 20' and the rail housing 202'.

[0300] The rotatable outer sheath knob 210' can be located on the distal end of the delivery housing 204', distal of the rail housing 202'. Rotation of the outer sheath knob 210' will pull the outer sheath assembly 22' proximally in an axial direction, thereby pulling the capsule 106' away from the implant 70 and releasing the implant 70. The distal end 303' of the implant 70 can be released first, followed by the proximal end 301' of the implant 70 as the outer sheath knob 210' continues to rotate.

[0301] The rotatable depth knob 212' can be on the proximal end of the delivery housing 204', and thus proximal of the rail housing 202'. When the depth knob 212' is rotated, the entire delivery housing 204' moves distally or proximally relative to the rail housing 202', which will remain 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 nosecone shaft assembly 30' move proximally or distally relative to the rail assembly 20'. Thus, the rail shaft 132' can be aligned in a particular direction, and the other assemblies can move distally or proximally relative to the rail shaft 132' for final positioning. The components can be advanced along the rail shaft 132' by about 1, 2, 3, 5, 6, 7, 8, 9, or 10 cm. The components can be advanced along the rail shaft 132' more than about 1, 2, 3, 5, 6, 7, 8, 9, or 10 cm. The capsule 106' can then be withdrawn, releasing the implant 70. Then, by rotating the depth knob 212' in the opposite direction, the assemblies other than the rail assembly 20' can be withdrawn over the rail shaft 132'.

[0302] delivery method

[0303] Figures 34-36 A release mechanism of the delivery system 10' is illustrated. During initial insertion of the prosthesis 70 and the delivery system 10' into the body, the prosthesis 70 can be located within the system 10', similar to Figure 26AThe distal end 303' of the prosthesis 70, and specifically the distal anchor 80, is constrained within the capsule 106' of the outer sheath assembly 22', thereby preventing expansion of the prosthesis 70. Similar to Figure 26A As shown in FIG. 6, the distal anchor 80 can extend distally when positioned in the capsule. The proximal end 301' of the prosthesis 70 is constrained within the capsule 106' and a portion of the inner retaining member 40', and thus is generally constrained between the capsule 106' and the inner retaining member 40'.

[0304] Using the steering mechanisms discussed herein or other techniques, the system 10' can first be positioned at a particular location within the patient's body, such as at the native mitral valve.

[0305] Once the prosthesis 70 is loaded into the delivery system 10', the user can thread a guide wire into the patient's body to the desired location. The guide wire passes through the lumen of the nosecone assembly 31', and thus the delivery system 10' can generally be pushed through the patient's body following the guide wire. 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 controlled.

[0306] Once generally within the heart, the user can begin steering the operation of the rail assembly 20' using the distal pull wire knob 206' and / or the proximal pull wire knob 208'. By turning either of the knobs, the user can provide a flexing / bending (at the distal or proximal end) of the rail assembly 20', thereby bending the distal end of the delivery system 10' into a desired configuration. As discussed above, the user can provide multiple bends in the rail assembly 20' to guide the delivery system 10' toward the mitral valve.

[0307] The user can also rotate and / or move the handle 14' itself in the stand to further adjust the distal end of the delivery system 10'. The user can continuously turn the proximal pull wire knob 208' and / or the distal pull wire knob 206', as well as move the handle 14' itself, to orient the delivery system 10' to release the prosthesis 70' into the body.

[0308] The user can then 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 nosecone assembly 31' over / through the rail assembly 20'. Due to the rigidity of, for example, the inner shaft assembly 18', these assemblies travel straight forward in the direction aligned by the rail assembly 20'.

[0309] Once in the released position, the user can rotate the outer sheath knob 210', which translates the outer sheath assembly 22' (and thus the capsule 106') in the proximal direction toward the handle 14', as shown in Figure 34 The distal end 303' of the prosthesis 70 is exposed in the body, allowing the expansion to begin. At this point, the distal anchors 80 can flip proximally, while the distal end 303' begins to expand radially outward. For example, if the system 10' has been delivered through an interpositioned path to the native mitral valve location, the nosecone is positioned in the left ventricle, with the prosthesis 70 generally perpendicular to the mitral annulus plane. The distal anchors 80 expand radially outward within the left ventricle. The distal anchors 80 can be positioned above the papillary heads, but below the mitral annulus and the mitral leaflets. In some embodiments, the distal anchors 80 can contact and / or extend between chordae in the left ventricle, as well as contact the leaflets as the distal anchors 80 radially expand. In some embodiments, the distal anchors 80 can not contact and / or extend between chordae or contact the leaflets. Depending on the location of the prosthesis 70, the distal end of the distal anchors 80 can be at or below the free edge where the chordae connect to the native leaflets.

[0310] Referring next to the steps of Figure 35 , the outer sheath assembly 22' can be further moved relatively distally away from the nosecone 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 can still be covered by the capsule 106' such that the proximal end 301' is still in a radially compressed state. At this point, the system 10' can be withdrawn proximally such that the distal anchors 80 capture and engage the leaflets of the mitral valve, or can be moved proximally to reposition the prosthesis 70. In addition, the system 10' can be twisted, which can cause the distal anchors 80 to exert a pulling force on the chordae, at least some of the distal anchors can extend between the chordae by the pulling force. However, in some embodiments, the distal anchors 80 can not exert a pulling force on the chordae. In some embodiments, after the outer sheath assembly 22' is withdrawn, the distal anchors 80 can capture the native leaflets and can be positioned between the chordae without any further movement of the system 10'

[0311] Thus, during this step, the system 10' can be moved proximally or distally to properly capture the native mitral valve leaflets by the distal or ventricular anchors 80. In particular, the tips of the ventricular anchors 80 can be moved proximally to engage the ventricular side of the native annulus such that the native leaflets are positioned between the anchors 80 and the body of the prosthesis 70. When the prosthesis 70 is in its final position, there can or can not be a pulling force on the chordae, although the distal anchors 80 can be positioned between at least some of the chordae.

[0312] 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.

[0313] 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.

[0314] 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.

[0315] Other valve prostheses

[0316] 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.

[0317] Next reference Figure 38AAn 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.

[0318] 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.

[0319] 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.

[0320] 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.

[0321] As shown in the example embodiment, the outer frame 1540 can include an outer frame body 1542. The outer frame body 1542 can have an upper region 1542a, a middle region 1542b, and a lower region 1542c. When in a configuration such as a fully expanded configuration, the outer frame body 1542 can have an enlarged shape, where 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 can advantageously allow the outer frame body 1542 to engage a native annulus, a native valve leaflet, or other tissue of a body lumen, while spacing the upper end from a heart or vessel wall.

[0322] The upper region 1542a of the outer frame body 1542 can include a first section 1546a and a second section 1546b. The first section 1546a can be sized and / or shaped to generally match the size and / or shape of the inner frame 1520. For example, the first section 1546a can have a curvature that matches the curvature of the upper region 1522a of the inner frame body 1522. The second section 1546b can extend radially outward away from the inner frame 1520. As shown in the example embodiment, the transition between the first section 1546a and the second section 1546b can include a bend, such that the second section 1546b extends radially outward at a greater angle relative to the longitudinal axis.

[0323] The middle region 1542b of the outer frame body 1542 can extend generally downward from the outwardly extending section 1546b of the upper region 1542a. As shown, the middle region 1542b can have a generally constant diameter from the upper end to the lower end, such that the middle region 1542b forms a generally cylindrical shape. The lower region 1542c of the outer frame body 1542 can extend generally downward from the lower end of the middle region 1542b. As shown, the lower region 1542c of the outer frame body 1542 can have a generally constant diameter from the upper end to the lower end, such that the lower region 1542c forms a generally cylindrical shape. As shown, the diameter of the middle region 1542b and the lower region 1542c are generally equal, such that the middle region 1542b and the lower region 1542c together form a generally cylindrical shape.

[0324] While the intermediate region 1542b and the lower region 1542c are described as cylindrical, it should be understood that the diameter of the upper end, the lower end, and / or the portion therebetween can be different. For example, the diameter of the portion between the upper end and the lower end can be greater than the upper end and the lower end, 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 can be greater than the diameter of the upper end. In other embodiments, the diameter of the upper end can be greater than the diameter of the lower end. Further, while the outer frame body 1542 has been described and illustrated as cylindrical or having a circular cross-section, it should be understood that all or a portion of the outer frame body 1542 can have a non-circular cross-section, such as, but not limited to, a D-shape, an elliptical or other oval cross-sectional shape.

[0325] The outer frame 1540, such as the outer frame body 1542, can be used to attach or secure the prosthesis 1500 to a native valve, such as a native 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 native valve annulus, tissue beyond the native valve annulus, the native leaflets, and / or other tissue located at or around the implant site during one or more phases of the cardiac cycle, such as the systolic phase and / or the diastolic phase. As another example, the outer frame body 1542 can be sized and positioned relative to the inner frame anchoring member 1524 such that tissue of the body lumen is positioned between the outer frame body 1542 and the inner frame anchoring member 1524, such as the native valve leaflets and / or the native valve annulus can be engaged or pinched to further secure the prosthesis 1500 to the tissue.

[0326] With continued reference to the example prosthesis 1500, Figure 38A The valve body 1560 is attached to the inner frame 1520, inside the inner frame body 1522, in the example prosthesis 1500. The valve body 1560 functions as a one-way valve to allow blood to flow in a first direction through the valve body 1560 and inhibit blood from flowing in a second direction through the valve body 1560.

[0327] Valve body 1560 can include a plurality of valve leaflets 1562, e.g., three leaflets 1562, joined at the commissure. Valve body 1560 can include one or more intermediate components 1564. Intermediate components 1564 can be positioned between a portion or all of leaflets 1562 and inner frame 1520 such that at least a portion of leaflets 1542 are coupled to frame 1520 via intermediate components 1564. In this manner, a portion or all of the portion of valve leaflets 1562 proximate the commissure and / or the cusp edges of valve leaflets 1562 are not directly coupled or attached to inner frame 1520, but are indirectly coupled to inner frame 1520 or "float" within it. For example, a portion or all of the portion of valve leaflets 1562 proximate the commissure and / or cusp edges of valve leaflets 1562 can be spaced radially inward from the inner surface of inner frame 1520. By using one or more intermediate components 1564, valve leaflets 1562 can be attached to a non-cylindrical frame 1520 and / or frame 1520 having a diameter greater than the diameter of valve leaflets 1562.

[0328] Referring next to Figure 38A With reference to the example outer skirt 1580 shown in

[0329] Referring next to Figure 38A With reference to the example inner skirt 1590 shown in

[0330] While the prosthesis 1500 has been described as including the inner frame 1520, the outer frame 1540, the valve body 1560, and the skirts 1580, 1590, it should be understood that the prosthesis 1500 need not include all components. For example, in some embodiments, the prosthesis 1500 can include the inner frame 1520, the outer frame 1540, and the valve body 1560, omitting the skirts 1580. Further, while the components of the prosthesis 1500 have been described and illustrated as separate components, it should be understood that one or more components of the prosthesis 1500 can be formed integrally or monolithically. For example, in some embodiments, the inner frame 1520 and the outer frame 1540 can be formed integrally or monolithically as a single component.

[0331] Figure 38B Alternative embodiments are illustrated Figure 38A where the design of the skirt (or cloth) 1580 / 1590 is modified. As shown, the skirt 1580 / 1590 can contact both the inner frame 1520 and the outer frame 1540. The skirt 1580 / 1590 can start from the inside of 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, then travel up the outside of the inner frame 1520. By closing the skirt 1580 / 1590, this can avoid / reduce clot formation / embolization.

[0332] Next referring to Figures 39-40 embodiments of a prosthesis 1600 in an expanded configuration are illustrated. This prosthesis 1600 can be similar in construction to the prosthesis 1500 described above. The prosthesis 1600 can 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.

[0333] Referring first to Figures 39-40 the outer frame 1640 illustrated in FIG. 16A, the outer frame 1640 can be attached to the inner frame 1620 using any known fasteners and / or techniques. While the outer frame 1640 is illustrated as a separate component from the inner frame 1620, it should be understood that the frames 1620, 1640 can be formed integrally or monolithically.

[0334] As shown in the example embodiment, the outer frame 1640 can include an outer frame body 1642. The outer frame body 1642 can 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 can be sized and / or shaped to generally 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 can include one or more struts that generally 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.

[0335] When in an expanded configuration, such as in a fully expanded configuration, the outer frame body 1642 can have a similar shape as the outer frame body 1542 described above. As shown, the middle region 1642b and the lower region 1642c can have a diameter that is greater than the diameter of the upper region 1642a. The upper region 1642a of the outer frame body 1642 can have a diameter that decreases from a lower end to an upper end, such that the upper region 1642a slopes or curves radially inward toward the longitudinal axis of the prosthesis 1600. Although the outer frame body 1642 has been described and illustrated as being cylindrical or having a circular cross-section, it should be understood that all or a portion of the outer frame body 1642 can have a non-circular cross-section, such as but not limited to a D-shape, an elliptical or other oval cross-sectional shape. Figure 38A

[0336] Continuing with the example outer frame 1600, the outer frame body 1642 can include a plurality of struts, at least some of which form cells 1646a-c. Any number of strut configurations can be used, such as the illustrated undulating struts in a ring that form ellipses, ovals, rounded polygons, and teardrop shapes, as well as V-shapes, diamonds, curves, and various other shapes. Figure 39 The upper row of cells 1646a can have an irregular octagonal shape, such as a "heart" shape. This additional space can beneficially allow the outer frame 1640 to maintain a smaller profile when crimped. The cells 1646a can be formed by a combination of struts. As shown in the example embodiment, the upper portion of the cells 1646a can be formed by a set of circumferentially expandable struts 1648a having a Z-shape or undulating shape that forms a repeating "V" shape. The struts 1648a can extend radially outward from an upper end to a lower end. These struts can generally match the size and / or shape of the struts of the inner frame 1620.

[0337]

[0338] ​​The middle portion of the cell 1646a can be formed by a set of struts 1648b extending downwardly from the base of each "V" shape. The struts 1648b can extend radially outwardly from the upper end to the lower end. The portion of the cell 1646a extending upwardly from the base of the struts 1648b can be considered a substantially unshortened portion of the outer frame 1640.

[0339] The lower portion of the cell 1646a can be formed by a set of circumferentially expandable struts 1648c having a Z-shape or undulating shape forming a repeating "V" shape. As shown in the example embodiment, the struts 1648c can include a curvature such that the lower end of the strut 1648c extends more parallel to the longitudinal axis than the upper end of the strut 1648c. One or more of the upper ends or apices of the circumferentially expandable struts 1648c can be "free" vertices that are not connected to a strut. For example, as shown in the example embodiment, every other upper end or apex of the circumferentially expandable struts 1648b is a free vertex. However, it should be understood that other configurations can be used. For example, every upper vertex along the upper end can be connected to a strut.

[0340] The middle and / or lower rows of cells 1646b-c can have a different shape than the first row of cells 1646a. The middle row of cells 1646b and the lower row of cells 1646c can have a diamond or substantially diamond shape. The diamond or substantially diamond shape can be formed by a combination of struts.

[0341] The upper portion of the cell 1646b can be formed by a set of circumferentially expandable struts 1648c such that the cell 1646b shares struts with the cell 1646a. The lower portion of the cell 1646b can 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 can extend substantially in a downward direction that is substantially parallel to the longitudinal axis of the outer frame 1640.

[0342] The upper portion of the cell 1646c can be formed by a set of circumferentially expandable struts 1648d such that the cell 1646c shares struts with the cell 1646b. The lower portion of the cell 1646c can be formed by a set of circumferentially expandable struts 1648e. The circumferentially expandable struts 1648e can extend substantially in a downward direction.

[0343] As shown in the example embodiment, there can be nine cells 1646a in a row and eighteen cells 1646b-c in a row. Although each of the cells 1646a-c is shown as having the same shape as the other cells 1646a-c in the same row, it should be understood that the shape of the cells 1646a-c within a certain row can differ. Further, it should be understood that any number of rows of cells can be used and any number of cells can be included in those rows.

[0344] As shown in the example embodiment, the outer frame 1600 can include a set of eyelets 1650. The upper set of eyelets 1650 can extend from the upper region 1642a of the outer frame body 1642. As shown, the upper set of eyelets 1650 can extend from the upper portion of the cell 1646a, such as the upper apex of the cell 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 can include one or more eyelets corresponding to the eyelets 1650. In such embodiments, the inner frame 1620 and the outer frame 1640 can 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 can be stitched together through the eyelets, or attached by other means such as mechanical fasteners (e.g., screws, rivets, etc.).

[0345] As shown, the set of eyelets 1650 can include two eyelets extending in series from each "V" shaped strut. This can reduce the likelihood of the outer frame 1640 twisting along the axis of the eyelets. However, it should be understood that some "V" shaped struts can not include eyelets. Further, it should be understood that a fewer or greater number of eyelets can extend from the "V" shaped struts.

[0346] The outer frame 1640 can include a set of locking tabs 1652 extending from the upper end of the upper region 1642a or near thereto. As shown, the locking tabs 1652 can extend upwardly from the set of eyelets 1650. The outer frame 1640 can include twelve locking tabs 1652. However, it should be understood that a greater or lesser number of locking tabs can be used. The locking tabs 1652 can include a longitudinally extending strut 1652a. At the upper end of the strut 1652a, the locking tab 1652 can include an enlarged head 1652b. As shown, the enlarged head 1652b can have a semi-circular or semi-elliptical shape forming a "mushroom" shape with the strut 1652a. The locking tab 1652 can include an eyelet 1652c, which can be positioned through the enlarged head 1652b. It should be understood that the locking tab 1652 can include eyelets in other locations, or can include more than a single eyelet.

[0347] 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.

[0348] 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.

[0349] 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.

[0350] Valve body 1660 can include a plurality of valve leaflets 1662, e.g., three leaflets 1662, joined at the commissure. Valve body 1660 can include one or more intermediate components 1664. Intermediate components 1664 can be positioned between a portion or all of leaflets 1662 and inner frame 1620 such that at least a portion of leaflets 1642 are coupled to frame 1620 via intermediate components 1664. In this way, a portion or all of the portion of valve leaflets 1662 at the commissure and / or the cusp edges of valve leaflets 1662 are not directly coupled or attached to inner frame 1620, but are indirectly coupled to inner frame 1620 or "float" within it.

[0351] Reference is next made to Figure 39 Intermediate example outer skirt 1680, outer skirt 1680 can be attached to inner frame 1620 and / or outer frame 1640. As shown, outer skirt 1680 can be positioned around a portion or all of the exterior of outer frame 1640 and secured to a portion or all of the exterior of outer frame 1640. Outer skirt 1680 can be attached to valve body 1660 and outer skirt 1680. As Figure 40 As shown in the intermediate example, a first end of inner skirt 1690 can be coupled to valve body 1660 along a portion of valve body 1660 proximate inner frame 1620. A second end of inner skirt 1690 can be attached to a lower region of outer skirt 1680. In this way, a smooth surface can be formed under each of the leaflets. This can beneficially enhance hemodynamics by allowing blood to circulate more freely and reduce stagnation areas.

[0352] While prosthesis 1600 has been described as including inner frame 1620, outer frame 1640, valve body 1660, and skirts 1680, 1690, it should be understood that prosthesis 1600 need not include all components. For example, in some embodiments, prosthesis 1600 can include inner frame 1620, outer frame 1640, and valve body 1660, omitting skirts 1680. Further, while the components of prosthesis 1600 have been described and illustrated as separate components, it should be understood that one or more components of prosthesis 1600 can be formed integrally or monolithically. For example, in some embodiments, inner frame 1620 and outer frame 1640 can be formed integrally or monolithically as a single component.

[0353] From the foregoing description, it will be appreciated that inventive products and approaches for implant delivery systems are disclosed. Although a few embodiments have been described in some detail, it will be appreciated that many modifications can be made to the particular designs, constructions and methods described above without departing from the spirit and scope of the disclosure.

[0354] Certain features described in the context of separate embodiments in the disclosure can also be implemented in combination in a single embodiment. Conversely, various features described in the context of a single embodiment can also be implemented separately or in any suitable subcombination. Furthermore, although features can be described above as acting in particular combinations, one or more features from a combination can in some cases be excised from the combination and the combination can be claimed as any number of separate combinations, or in any suitable subcombination.

[0355] Moreover, although method can be depicted in the drawings or described above in a particular order, this should not be understood as requiring or implying that such methods be performed in the particular order shown or in the order indicated at all, nor that all of the methods be performed, to achieve desirable results. Other methods can be employed besides those specifically described. For example, one or more other methods can be performed either prior to, subsequent to, or in place of, any described method. Further, methods can be rearranged or reordered in other embodiments. Also, the separation of various system components in the embodiments described above should not be understood as requiring such separation in all embodiments, and it should be understood that the described components and systems can generally be integrated in a single product or packaged into multiple products. Additionally, other embodiments are within the scope of the disclosure.

[0356] Conditional language, such as "can," "could," "might," or "may," unless specifically stated otherwise, generally are intended to convey that certain embodiments include, while other embodiments do not include, certain features, elements, and / or steps. Thus, such conditional language is not generally intended to imply that features, elements, and / or steps are in any way required for one or more embodiments or that one or more embodiments necessarily include logic for deciding, with or without other input or prompting, whether these features, elements, and / or steps are included or are to be performed one or more times.

[0357] Connective language, such as the phrase "at least one of X, Y, and Z," is not generally intended to convey that certain embodiments include only one of X, Y, and Z. Rather, such connective language is generally intended to convey that certain embodiments include at least one of X, Y, or Z.

[0358] As used herein, the degree language such as the terms "about," "approximately," "substantially," and "essentially" as used herein mean a value, amount, or characteristic that is acceptable within close limits of or that is within less than 10%, less than 5%, less than 1%, less than 0.1%, less than 0.01% of a stated value, amount or characteristic. If the stated value is zero (e.g., none, no), the above defined ranges can be specific ranges and not within a particular percentage of the value. For example, within less than or equal to 10 wt. / vol.%, within less than or equal to 5 wt. / vol.%, within less than or equal to 1 wt. / vol.%, within less than or equal to 0.1 wt. / vol.%, and within less than or equal to 0.01 wt. / vol.% of the stated value.

[0359] Some implementations have been described in connection with the accompanying drawings. The drawings are not drawn to scale but such scaling should not be considered a limitation as other dimensions and proportions are contemplated and within the scope of the disclosed invention. Distances, angles, etc. are merely exemplary and not necessarily related to actual dimensions and layout of the devices illustrated. Components can be added, removed, and / or rearranged. Further, any particular feature, aspect, method, property, characteristic, quality, attribute, element, etc. in the present disclosure can be used in all other implementations described herein in conjunction with various implementations. In addition, it will be appreciated that any of the methods described herein can be practiced using any device suitable for performing the defined steps.

[0360] While multiple implementations have been described in detail, other modifications and uses will be apparent to those skilled in the art. It is the scope of the disclosed implementations, not the specific implementations that is intended to be exemplary and illustrative, and changes learned by those skilled in the art, using no more than their common general knowledge, are intended to be encompassed by provisions of the appended claims.

Claims

1. A delivery system for delivering an expandable implant to a body location, the delivery system comprising: an outer sheath assembly comprising an outer shaft having an outer lumen and a proximal end and a distal end, wherein the outer sheath assembly comprises an implant retention region configured to retain the expandable implant in a compressed configuration; wherein the outer sheath assembly comprises a capsule at the distal end, the capsule adapted to provide resistance to compression and flexibility and comprising: an outer polymer layer comprised of a flexible material configured to provide stretch / elongation properties; a metallic intermediate layer on a radially inner surface of the outer polymer layer, the metallic intermediate layer configured to provide resistance to compression, wherein the metallic intermediate layer comprises a coil or hypotube; and an inner liner on a radially inner surface of the metallic intermediate layer.

2. The delivery system of claim 1, wherein the metallic intermediate layer is at least partially a metallic coil.

3. The delivery system of claim 1, wherein the metallic intermediate layer comprises one or more compression coils.

4. The delivery system of claim 3, wherein a size of the one or more compression coils varies along a length of the capsule.

5. The delivery system of claim 1, wherein the outer polymer layer comprises an elastomer.

6. The delivery system of any one of claims 1-4, wherein the outer polymer layer comprises polytetrafluoroethylene (PTFE).

7. The delivery system of any one of claims 1-4, wherein the outer polymer layer comprises expanded polytetrafluoroethylene (ePTFE).

8. The delivery system of any one of claims 1-4, wherein the outer polymer layer is pre-axially stressed prior to application to the capsule.

9. The delivery system of any one of claims 1-4, further comprising a fluorinated elastomer layer between at least a portion of the outer polymer layer and the metallic intermediate layer.

10. The delivery system of any one of claims 1-4, further comprising one or more fluorinated ethylene propylene segments between the outer polymer layer and the metallic intermediate layer to provide radial strength when the expandable implant is under compression.

11. The delivery system of claim 10, wherein the one or more fluorinated ethylene propylene segments are at at least the proximal and distal ends of the capsule.

12. The delivery system of any one of claims 1-4, wherein the inner liner comprises ePTFE.

13. The delivery system of any one of claims 1-4, wherein the inner liner comprises pre-axially compressed PTFE.

14. The delivery system of claim 13, wherein the inner liner is wrapped around the distal end of the capsule and in contact with a radially outer surface of the outer polymer layer.

15. A delivery system for delivering an expandable implant to a body location, the delivery system comprising: An outer sheath assembly comprising an outer shaft having an outer lumen and a proximal end and a distal end, wherein the outer sheath assembly comprises an implant retention region configured to retain the expandable implant in a compressed configuration; wherein the outer sheath assembly comprises a capsule at the distal end, the capsule adapted to provide resistance to compression and flexibility and comprising: an outer polymer layer comprised of a flexible material configured to provide tensile / elongation properties; a metallic intermediate layer on a radially inner surface of the outer polymer layer, the metallic intermediate layer configured to provide resistance to compression, wherein the metallic intermediate layer comprises a coil or hypotube; and an inner liner on a radially inner surface of the metallic intermediate layer; a track assembly within the outer lumen, the track assembly comprising a track shaft having a track lumen and a proximal end and a distal end, wherein the track assembly comprises one or more pull wires attached on an inner surface of the track shaft, the pull wires configured to provide an axial force on the track shaft to steer the track assembly; an inner assembly within the outer lumen, the inner assembly comprising an inner shaft having an inner lumen and a proximal end and a distal end, wherein the inner assembly comprises an inner retention member configured to releasably attach to the expandable implant; and a handle, wherein the handle comprises: a first knob configured to translate the outer sheath assembly and the inner assembly together distally relative to the track assembly while the expandable implant is retained in the compressed configuration; and a second knob configured to proximally retract the outer sheath assembly relative to the inner assembly so as to at least partially expand the expandable implant from the compressed configuration.

16. The delivery system of claim 15, further comprising a mid-shaft assembly within the outer lumen, the mid-shaft assembly comprising a mid-shaft having a mid-lumen and a proximal end and a distal end.

17. The delivery system of claim 16, wherein the mid-shaft assembly comprises an outer retention member configured to radially retain at least a portion of the expandable implant.

18. The delivery system of claim 16, wherein the first knob is configured to translate the mid-shaft assembly relative to the track assembly together with the outer sheath assembly and the inner assembly while the expandable implant is retained in the compressed configuration.

19. The delivery system of claim 16, wherein the handle further comprises a third knob configured to proximally retract the mid-shaft assembly relative to the inner assembly to transition the expandable implant to a fully expanded configuration.

20. The delivery system of claim 17, wherein the outer retention member comprises an inner liner wrapped around a distal end of the outer retention member and in contact with a radially outer surface of the outer retention member.

21. The delivery system of claim 15, further comprising the expandable implant.

22. The delivery system of claim 21, wherein the expandable implant comprises a replacement heart valve comprising a plurality of anchors configured to be positioned on a ventricular side of a native heart valve annulus.

23. A delivery system for delivering an expandable implant to a body location, the delivery system comprising: an outer sheath assembly comprising an outer shaft having an outer lumen, a proximal end and a distal end, wherein the outer sheath assembly comprises an implant retention region configured to retain the expandable implant in a compressed configuration; wherein the outer sheath assembly comprises a capsule at the distal end, the capsule adapted to provide resistance to compression and flexibility and comprising: an outer polymer layer comprised of a flexible material configured to provide tensile / elongation properties; a metallic intermediate layer on a radially inner surface of the outer polymer layer, the metallic intermediate layer configured to provide resistance to compression, wherein the metallic intermediate layer comprises a coil or hypotube; and an inner liner on a radially inner surface of the metallic intermediate layer; a rail assembly within the outer lumen, the rail assembly comprising a rail shaft having a rail lumen, a proximal end and a distal end, wherein the rail assembly comprises one or more pull wires attached on an inner surface of the rail shaft, the one or more pull wires configured to provide an axial force on the rail shaft to steer the rail assembly; an inner assembly within the outer lumen, the inner assembly comprising an inner shaft having an inner lumen, a proximal end and a distal end, wherein the inner assembly comprises an inner retention member configured to releasably attach to the expandable implant; and a mid-shaft assembly within the outer lumen, the mid-shaft assembly comprising a mid-shaft having a mid-lumen, a proximal end and a distal end, wherein the mid-shaft assembly comprises an outer retention member configured to radially retain at least a portion of the expandable implant; wherein the outer sheath assembly, the mid-shaft assembly and the inner assembly are configured to move together distally relative to the rail assembly when the expandable implant is retained in the compressed configuration; and wherein the outer sheath assembly and the mid-shaft assembly are configured to individually retract proximally relative to the inner assembly to at least partially expand the expandable implant from the compressed configuration.

24. The delivery system of claim 23, further comprising a handle comprising a first actuator configured to move the outer sheath assembly, the mid-shaft assembly and the inner assembly together relative to the rail assembly.

25. The delivery system of claim 24, wherein the handle further comprises a second actuator configured to individually retract the outer sheath assembly proximally relative to the inner assembly to allow the expandable implant to transition to a partially expanded configuration.

26. The delivery system of claim 25, wherein the handle further comprises a third actuator configured to independently proximally retract the middle shaft assembly relative to the inner assembly to allow the expandable implant to transition to a fully expanded configuration.

27. The delivery system of claim 26, wherein the first, second, and third actuators are rotatable knobs.

28. A system comprising: an expandable implant comprising an outer frame and a separate inner frame attached to the outer frame, the expandable implant configured to transition between a compressed configuration and an expanded configuration, the outer frame configured to engage tissue of a native heart valve annulus upon transitioning the expandable implant to the expanded configuration, the inner frame comprising an anchor configured to engage a native heart valve leaflet upon transitioning the expandable implant to the expanded configuration, the expandable implant further comprising a valve body comprising a plurality of prosthetic valve leaflets; and a delivery system comprising: an outer sheath assembly having an outer lumen, a proximal end, and a distal end, wherein the outer sheath assembly comprises an implant retention region configured to retain the expandable implant in the compressed configuration; wherein the outer sheath assembly comprises a capsule at the distal end, the capsule adapted to provide resistance to compression and flexibility and comprising: an outer polymer layer comprised of a flexible material configured to provide tensile / elongation properties; a metallic intermediate layer on a radially inner surface of the outer polymer layer, the metallic intermediate layer configured to provide resistance to compression, wherein the metallic intermediate layer comprises a coil or hypotube; and an inner liner on a radially inner surface of the metallic intermediate layer; a rail assembly within the outer lumen, the rail assembly comprising a rail shaft having a rail lumen, a proximal end, and a distal end, wherein the rail assembly comprises one or more pull wires attached on an inner surface of the rail shaft, the pull wires configured to provide axial forces on the rail shaft to steer the rail assembly; an inner assembly within the outer lumen, the inner assembly comprising an inner shaft having an inner lumen, a proximal end, and a distal end, wherein the inner assembly comprises an inner retention member configured to releasably attach to one or more locking tabs of the outer frame of the expandable implant; wherein the outer sheath assembly and the inner assembly are configured to move together distally relative to the rail assembly when the expandable implant is retained in the compressed configuration; and wherein the outer sheath assembly is configured to be independently proximally retracted relative to the inner assembly to at least partially expand the expandable implant from the compressed configuration.

29. The system of claim 28, further comprising a handle, the handle including a first actuator configured to move the outer sheath assembly and the inner assembly together relative to the track assembly.

30. The system of claim 29, wherein the handle includes a second actuator configured to independently proximally retract the outer sheath assembly relative to the inner assembly to allow the expandable implant to transition to a partially expanded configuration.

31. The system of claim 30, wherein the first and second actuators are rotatable knobs.

32. The system of claim 29, further comprising a midshaft assembly within the outer lumen, the midshaft assembly including a midshaft having a midlumen and proximal and distal ends.

33. The system of claim 32, wherein the midshaft assembly includes an outer retention member configured to radially retain at least a portion of the expandable implant.

34. The system of claim 33, wherein the first actuator is configured to move the midshaft assembly relative to the track assembly with the outer sheath assembly and the inner assembly.

35. The system of claim 34, wherein the handle further includes a third knob configured to proximally retract the midshaft assembly relative to the inner assembly.

36. The system of claim 33, wherein the outer retention member includes an inner liner wrapped around a distal end of the outer retention member and in contact with a radially outer surface of the outer retention member.

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