Delivery system and tether assembly for prosthetic valves

Abstract

A system for replacing the function of a native atrioventricular valve includes a prosthetic heart valve and a steerable delivery catheter. A balloon or sheath is disposed along the distal portion of the delivery catheter for maintaining the prosthetic heart valve in a compressed state during advancement through the vasculature. The tether assembly extends through the delivery catheter and includes a coupling tether adapted to pass through an opening in the prosthetic heart valve. The release assembly includes a release tether for locking the coupling tether to the prosthetic heart valve. The release tether is retractable for detaching the coupling tether from the prosthetic heart valve. The prosthetic heart valve may be released from the balloon and allowed to expand and operate as a one-way valve while still being attached to the tether assembly. The prosthetic heart valve may then be detached from the tether assembly after confirming proper deployment.

Description

[0001] Cross - Reference to Related Applications This application claims the benefit of U.S. Provisional Application No. 63 / 436,051, filed on Dec. 29, 2022, and U.S. Provisional Application No. 63 / 533,458, filed on Aug. 18, 2023, the entire contents of each of which are hereby incorporated by reference. Technical Field

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

[0003] Human heart valves, including the aortic, pulmonary, mitral, and tricuspid valves, function essentially as one - way valves that operate in synchrony with the pumping of the heart. The valves allow blood to flow downstream but prevent blood from flowing upstream. Diseased heart valves exhibit impairments, such as stenosis or regurgitation, which inhibit the ability of the valve to control blood flow. Such impairments reduce the blood - pumping efficiency of the heart and can lead to debilitating and life - threatening conditions. For example, valvular insufficiency can result in conditions such as cardiac hypertrophy and ventricular dilation. Accordingly, significant efforts have been made to develop methods and devices for repairing or replacing damaged heart valves.

[0004] Prostheses exist to correct problems associated with damaged heart valves. For example, mechanical and tissue - based heart valve prostheses can be used to replace damaged native heart valves. More recently, significant efforts have been directed towards developing replacement heart valves, particularly tissue - based replacement heart valves, which can be delivered with less trauma to the patient compared to open - heart surgery. Replacement valves are designed to be delivered via minimally invasive surgery and even percutaneous procedures. Such replacement valves typically include prosthetic valve leaflets that are attached to an expandable frame, which is then delivered to the annulus of the native valve.

[0005] The development of prostheses, including but not limited to replacement heart valves, has proven to be particularly challenging, which can be compressed for delivery and then controllably expanded for controlled placement. Additional challenges involve the ability of such prostheses to be fixed relative to tissue within the lumen (e.g., tissue within any body lumen or body cavity) in a manner that prevents damage.

[0006] Delivering a prosthesis to a desired location within the human body, such as delivering a replacement heart valve to the mitral or tricuspid valve, can also be challenging. Gaining access to perform surgery at the heart or other anatomical locations may require navigating through tortuous vasculature or through open or semi-open surgical percutaneous delivery devices. The ability to control prosthesis deployment at the desired location is also challenging. Summary of the Invention

[0007] Examples of the present disclosure may relate to implants that may include prostheses, such as but not limited to replacement heart valves. Additional examples relate to methods for delivering and / or controllably deploying an implant, such as but not limited to a replacement heart valve, to a desired location within the body. In some examples, a replacement heart valve and a method for delivering the replacement heart valve to an autologous heart valve, such as the mitral valve, aortic valve, or tricuspid valve, are provided.

[0008] Configurations of delivery systems and release mechanisms for implants may be disclosed herein.

[0009] Examples of the present disclosure may include a delivery system for an implant. The delivery system may include an elongate shaft for advancing the implant to an implantation site and including a proximal portion and a distal portion, with at least a portion of the elongate shaft including a tether assembly. The tether assembly may include a plurality of coupling tethers configured to be coupled to the implant, a tether manifold for coupling to the plurality of coupling tethers, and a flexible retention tether coupled to the tether manifold and extending proximally from the tether manifold.

[0010] Examples of the present disclosure may include a method. The method may include delivering an implant to an autologous heart valve using a delivery system. The delivery system may include an elongate shaft for advancing the implant to the autologous heart valve and including a proximal portion and a distal portion, with at least a portion of the elongate shaft including a tether assembly. The tether assembly may include a plurality of coupling tethers configured to be coupled to the implant, a tether manifold for coupling to the plurality of coupling tethers, and a flexible retention tether coupled to the tether manifold and extending proximally from the tether manifold.

[0011] Examples of the present disclosure may include a delivery system for an implant. The delivery system may include an elongate shaft for advancing the implant to an implantation site and including a proximal portion and a distal portion, at least a portion of the elongate shaft including a tether assembly and a release assembly. The tether assembly may include one or more coupling tethers configured to be coupled to the implant, each coupling tether including a loop portion configured to project from a corresponding opening in a portion of the implant. The release assembly may include one or more release tethers configured to extend through one or more of the loop portions to hold the implant to the one or more loop portions, the one or more release tethers configured to retract from the one or more loop portions to release the implant from the one or more loop portions.

[0012] Examples of the present disclosure may include a method. The method may include delivering an implant to an autologous heart valve using a delivery system. The delivery system may include an elongate shaft for advancing the implant to the autologous heart valve and including a proximal portion and a distal portion. At least a portion of the elongate shaft may include a tether assembly and a release assembly. The tether assembly may include one or more coupling tethers configured to be coupled to the implant, each coupling tether including a loop portion configured to project from a corresponding opening in a portion of the implant. The release assembly may include one or more release tethers configured to extend through one or more of the loop portions to hold the implant to the one or more loop portions, the one or more release tethers configured to retract from the one or more loop portions to release the implant from the one or more loop portions.

[0013] Examples of the present disclosure may include a delivery system for an implant. The delivery system may include an elongate shaft for advancing the implant to an implantation site and including a proximal portion and a distal portion. The delivery system may include one or more coupling tethers, each coupling tether including a first portion and a second portion, the first portion configured to be coupled to the implant to hold the implant to the elongate shaft. The delivery system may include a disintegration assembly configured to connect to the second portion of the one or more coupling tethers and disintegrate the connection to the second portion to release the implant from the elongate shaft.

[0014] Examples of the present disclosure may include a method. The method may include delivering an implant to an autologous heart valve using a delivery system. The delivery system may include: a elongate shaft configured to advance the implant to the autologous heart valve and including a proximal portion and a distal portion; one or more coupling tethers, each coupling tether including a first portion and a second portion, the first portion being configured to couple to the implant to hold the implant to the elongate shaft; and a disintegration assembly configured to connect to the second portion of the one or more coupling tethers and disintegrate the connection with the second portion to release the implant from the elongate shaft.

[0015] Examples of the present disclosure may include a delivery system for an implant. The delivery system may include a delivery catheter configured to advance the implant to an implantation site, the delivery catheter including an elongate shaft adapted to deflect in one or more planes. The elongate shaft may have: an outer sheath having a distal portion and a proximal portion and a length; a pull tether having a distal portion and a proximal portion and extending along the length of the outer sheath, the distal portion being coupled to the outer sheath; a compression coil surrounding at least a portion of the pull tether and including a distal portion and a proximal portion, the compression coil not being directly connected to the outer sheath and being slidable relative to the pull tether; and a tube surrounding at least a portion of the pull tether and including a distal portion and a proximal portion, the tube not being directly connected to the outer sheath and being slidable relative to the pull tether, the distal portion of the tube being adapted to abut the proximal portion of the compression coil. The delivery catheter may include a support plate including an opening for the pull tether to pass through, the support plate being adapted to abut the proximal portion of the tube. The delivery catheter may include a housing slidably engaged with the proximal portion of the outer sheath. The delivery catheter may include an actuator assembly configured to apply tension to the pull tether to deflect the elongate shaft, whereby a force applied to the compression coil is transmitted through the tube to the support plate.

[0016] Examples of the present disclosure may include a method. The method may include delivering an implant to an autologous heart valve using a delivery system. The delivery system may include a delivery catheter for advancing the implant to an implantation site, the delivery catheter including an elongate shaft adapted to deflect in one or more planes. The elongate shaft may have: an outer sheath having a distal portion, a proximal portion, and a length; a pull tether having a distal portion and a proximal portion and extending along the length of the outer sheath, the distal portion being coupled to the outer sheath; a compression coil surrounding at least a portion of the pull tether and including a distal portion and a proximal portion, the compression coil not being directly connected to the outer sheath and being slidable relative to the pull tether; and a tube surrounding at least a portion of the pull tether and including a distal portion and a proximal portion, the tube not being directly connected to the outer sheath and being slidable relative to the pull tether, the distal portion of the tube being adapted to dock with the proximal portion of the compression coil. The delivery catheter may include a support plate including an opening for the pull tether to pass through, the support plate being adapted to dock with the proximal portion of the tube. The delivery catheter may include a housing slidably engaged with the proximal portion of the outer sheath. The delivery catheter may include an actuator assembly for applying tension to the pull tether to deflect the elongate shaft, whereby the force applied on the compression coil is transmitted through the tube to the support plate.

[0017] Examples of the present disclosure may include a delivery system for an implant. The delivery system may include a delivery catheter for advancing the implant to an implantation site, the delivery catheter including an elongate shaft adapted to deflect in one or more planes. The elongate shaft may include: an outer sheath having a distal portion, a proximal portion, and a length; a pull tether having a distal portion and a proximal portion and extending along the length of the outer sheath, the distal portion being coupled to the outer sheath; a lumen surrounding at least a portion of the pull tether and including a distal portion and a proximal portion, the lumen not being directly connected to the outer sheath and being slidable relative to the pull tether. The delivery catheter may include an actuator assembly for applying tension to the pull tether to deflect the elongate shaft and, simultaneously, applying a distal compressive force to the lumen.

[0018] Examples of the present disclosure may include a method. The method may include delivering an implant to an autologous heart valve using a delivery system. The delivery system may include a delivery catheter for advancing the implant to an implantation site, the delivery catheter including an elongate shaft adapted to deflect in one or more planes. The elongate shaft may include: an outer sheath having a distal portion and a proximal portion and a length; a pull tether having a distal portion and a proximal portion and extending along the length of the outer sheath, the distal portion being coupled to the outer sheath; a lumen surrounding at least a portion of the pull tether and including a distal portion and a proximal portion, the lumen not being directly connected to the outer sheath and being slidable relative to the pull tether. The delivery catheter may include an actuator assembly for applying tension to the pull tether to deflect the elongate shaft and, simultaneously, applying a distal compressive force to the lumen.

[0019] Examples of the present disclosure may include a delivery system for an implant. The delivery system may include an elongate shaft for advancing the implant to an implantation site and including a proximal portion and a distal portion, the elongate shaft being adapted to deflect in a first plane about a curved portion of the elongate shaft. The delivery system may include a control mechanism adapted to control the deflection of the elongate shaft. The control mechanism may include: a deflection actuator adapted to deflect the elongate shaft about the curved portion in the first plane; a pull tether assembly including a pull tether and an adapter, the pull tether including a distal portion coupled to the elongate shaft and a proximal portion coupled to the adapter; and a knob assembly adapted to rotate in a first direction to produce a depth of the distal portion of the elongate shaft relative to the curved portion and rotate in a second direction to retract the adapter to deflect the elongate shaft to produce a height of the elongate shaft in a direction opposite the depth.

[0020] Examples of the present disclosure may include a method. The method may include delivering an implant to an autologous heart valve using a delivery system. The delivery system may include an elongate shaft for advancing the implant to an implantation site and including a proximal portion and a distal portion, the elongate shaft being adapted to deflect in a first plane about a curved portion of the elongate shaft. The delivery system may include a control mechanism adapted to control the deflection of the elongate shaft. The control mechanism may include: a deflection actuator adapted to deflect the elongate shaft about the curved portion in the first plane; a traction tether assembly including a traction tether and an adapter, the traction tether including a proximal portion coupled to the distal portion of the elongate shaft and a proximal portion coupled to the adapter; and a knob assembly adapted to rotate in a first direction to create a depth of the distal portion of the elongate shaft relative to the curved portion, and to rotate in a second direction to retract the adapter to deflect the elongate shaft to create a height of the elongate shaft in a direction opposite the depth.

[0021] Examples of the present disclosure may include a delivery system for an implant. The delivery system may include a delivery catheter for advancing the implant to an implantation site, the delivery catheter including: a guidewire sheath having a proximal portion and a distal end and an internal lumen for passing a guidewire therethrough, the internal lumen having a diameter; and a spacer body positioned at the distal end of the guidewire sheath and projecting distally therefrom, the spacer body including an opening through which the guidewire projects and a cavity having a diameter greater than the diameter of the internal lumen and adapted for the guidewire to deflect therein.

[0022] Examples of the present disclosure may include a method. The method may include delivering an implant to an autologous heart valve using a delivery system. The delivery system may include a delivery catheter for advancing the implant to an implantation site, the delivery catheter including: a guidewire sheath having a proximal portion and a distal end and an internal lumen for passing a guidewire therethrough, the internal lumen having a diameter; and a spacer body positioned at the distal end of the guidewire sheath and projecting distally therefrom, the spacer body including an opening through which the guidewire projects and a cavity having a diameter greater than the diameter of the internal lumen and adapted for the guidewire to deflect therein. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] Figure 1 A side view of a delivery system for an implant is shown.

[0024] Figure 2 Shows Figure 1 A perspective view of an outer sheath subassembly of a delivery device of the delivery system of

[0025] Figure 3 Shown Figure 2 A side cross-sectional view of the bladder subassembly of the outer sheath subassembly.

[0026] Figure 4 Shown Figure 2 A perspective view of the balloon stent or distal hypotube of the outer sheath subassembly.

[0027] Figure 5 Schematically illustrates how a portion of the liner extending along the length of the outer jacket subassembly may have built-in slack to facilitate flexible bending of the outer jacket subassembly.

[0028] Figure 6 Shown Figure 2 A perspective view of the guide rail subassembly of the delivery device of the delivery system.

[0029] Figure 7 Shown Figure 6 A side cross-sectional view of the guide rail subassembly.

[0030] Figure 8 and 9 Schematically illustrates how the outer compression coil and puller wires of the rail subassembly may have a longer length than the inner compression coil and puller wires.

[0031] Figure 10 Shown Figure 2 A perspective view of the midshaft subassembly of the delivery device of the delivery system.

[0032] Figure 11 Shown Figure 10 A side cross-sectional view of the midshaft subassembly.

[0033] Figure 12 A side view of the tether assembly is shown.

[0034] Figure 13 A side view of an end portion of a tether assembly is shown.

[0035] Figure 14 A side view of a portion of a tether assembly is shown.

[0036] Figure 15 A side view of the tether assembly is shown.

[0037] Figure 16 A side view of the tether assembly is shown.

[0038] Figure 17 A perspective view of an end portion of a tether assembly is shown.

[0039] Figure 18 A perspective view of an implant coupled to a tether assembly is shown.

[0040] Figure 19 Shows a side view of the release assembly.

[0041] Figure 20 Shows a perspective view of the release assembly extending through the loop portion of the tether assembly.

[0042] Figure 21 Shows a perspective view of the release assembly retracted through the loop portion of the tether assembly.

[0043] Figure 22 Shows a perspective view of the release assembly retracted through the loop portion of the tether assembly.

[0044] Figure 23 Shows a perspective view of the tether assembly released from the implant.

[0045] Figure 24 Shows a perspective view of the handle of the delivery system.

[0046] Figure 25 Shows Figure 24 A cross-sectional view of the handle shown in

[0047] Figure 26 Shows a schematic view of the delivery system approaching the implant site.

[0048] Figure 27 Shows a schematic view of the delivery system approaching the tricuspid valve.

[0049] Figure 28 Shows a schematic view of the implant being deployed to the tricuspid valve.

[0050] Figure 29 Shows a schematic view of the implant being deployed to the tricuspid valve.

[0051] Figure 30 Shows a schematic view of the tether assembly released from the implant.

[0052] Figure 31 Shows a side view of the prosthetic valve deployed to the tricuspid valve.

[0053] Figure 32 Shows a partially exploded perspective view of the components of the disintegration assembly.

[0054] Figure 33 Shows a perspective view of the implant held by the pusher.

[0055] Figure 34 Shows from Figure 33 A side view of the implant extending from the pusher shown in

[0056] Figure 35A side cross-sectional view of a delivery system including a disintegration component is shown.

[0057] Figure 36 A side cross-sectional view is shown Figure 35 of the delivery system shown in [above reference], where the disintegration component is activated.

[0058] Figure 37 A side view of a disintegrated coupling tether extending into an implant is shown.

[0059] Figure 38 A side cross-sectional view of components of the disintegration component is shown.

[0060] Figure 39 A side cross-sectional view is shown Figure 38 of the disintegration component of [above reference], where the middle body has disintegrated.

[0061] Figure 40 A side cross-sectional view of components of the disintegration component is shown.

[0062] Figure 41 A side cross-sectional view is shown Figure 40 of the disintegration component of [above reference], where the disintegration component is activated.

[0063] Figure 42 A side view of a plurality of coupling tethers extending distally is shown.

[0064] Figure 43 A partial cross-sectional view of a coupling tether forming a loop shown in Figure 42 [above reference] is shown.

[0065] Figure 44 A partial cross-sectional view of a coupling tether forming a loop shown in Figure 42 [above reference] is shown.

[0066] Figure 45 A perspective view of a woven or braided cylinder is shown.

[0067] Figure 46 A perspective view of a ring cut from the woven or braided cylinder shown in Figure 45 [above reference] is shown.

[0068] Figure 47 A side partial cross-sectional view of a ring shown in Figure 46 [above reference] coupled to a tether manifold is shown.

[0069] Figure 48 A plan view of a fabric is shown.

[0070] Figure 49 A plan view of a fabric shown in Figure 48 [above reference] that has been cut is shown.

[0071] Figure 50 shows the fabric folded onto itself Figure 49 and a plan view of the fabric shown in

[0072] Figure 51 and a side cross-sectional schematic view of the weaving pattern

[0073] Figure 52 and a side schematic view showing the length of a section of the weaving pattern

[0074] Figure 53 and a side schematic view of the knitting assembly

[0075] Figure 54 and a side schematic view of the knitting performed by the knitting assembly

[0076] Figure 55 and a side view of the knitted tether assembly

[0077] Figure 56A and a perspective view of the release assembly

[0078] Figure 56B shows Figure 56A and a cross-sectional view of the release assembly shown in

[0079] Figure 57 and a cross-sectional view of the release assembly

[0080] Figure 58 and a plan view of the tether assembly

[0081] Figure 59 shows Figure 58 and a partial cross-sectional view of the tether assembly shown in

[0082] Figure 60A and a perspective view of the tether manifold

[0083] Figure 60B shows the Figure 60A and a partial cross-sectional view of the tether assembly using the tether manifold shown in

[0084] Figure 61 shows Figure 60B a cross-sectional view of the tether assembly along line I-I

[0085] Figure 62 and a side view of the delivery system

[0086] Figure 63 shows Figure 62 and a perspective view of the handle of the delivery system shown in

[0087] Figure 64 shows Figure 62Side view of the handle of the delivery system shown in

[0088] Figure 65 is shown Figure 62 Perspective cross-sectional view of the handle of the delivery system shown in along the centerline.

[0089] Figure 66 is shown Figure 62 Side cross-sectional view of the handle of the delivery system shown in along the centerline.

[0090] Figure 67 Perspective view of the guide rail shaft or elongate shaft of the delivery system is shown.

[0091] Figure 68 is shown Figure 67 Perspective view of the guide rail shaft shown in , with the outer sheath excluded from the view.

[0092] Figure 69 is shown Figure 67 Perspective view of the distal insert of the guide rail shaft shown in .

[0093] Figure 70 is shown Figure 67 Side perspective view of the intermediate insert of the guide rail shaft shown in .

[0094] Figure 71 Perspective view of the guide rail shaft is shown, with the outer sheath excluded from the view.

[0095] Figure 72 is shown Figure 71 Perspective view of the intermediate insert of the guide rail shaft shown in .

[0096] Figure 73 Perspective view of the adapter of the guide rail shaft is shown.

[0097] Figure 74 Perspective view of the adapter of the guide rail shaft is shown, with the outer sheath adapter excluded from the view.

[0098] [[ID=,55]] Figure 75 is shown Figure 73 Cross-sectional view of the adapter shown in .

[0099] Figure 76 is shown using the adapter as shown in Figure 73 Perspective cross-sectional view of the handle.

[0100] Figure 77 Side cross-sectional view of the actuator assembly is shown.

[0101] Figure 78 and 79 is shown Figure 77Schematic diagram of the operation of one of the actuator assemblies shown in

[0102] Figure 80 Shows the actuator assembly positioned on the handle Figure 77 Side view of the actuator assembly.

[0103] Figure 81 Side cross-sectional view of the knob assembly is shown.

[0104] Figure 82 Shows Figure 81 Side partial cross-sectional view of the knob assembly shown in

[0105] Figure 83 Shows Figure 81 Perspective partial cross-sectional view of the knob assembly shown in

[0106] Figure 84 Shows Figure 81 Perspective cross-sectional view of the knob assembly shown in

[0107] Figure 85 Shows Figure 81 Perspective partial cross-sectional view of the knob assembly shown in Figure 81 seen from the side of the handle opposite to the side shown in

[0108] Figure 86 Side partial cross-sectional view of the handle and the knob assembly is shown.

[0109] Figure 87 Shows a side schematic view of a delivery system according to the configuration shown in Figure 86

[0110] Figure 88 Side partial cross-sectional view of the handle and the knob assembly is shown.

[0111] Figure 89 Shows a side schematic view of a delivery system according to the configuration shown in Figure 88

[0112] Figure 90 Side partial cross-sectional view of the handle and the knob assembly is shown.

[0113] Figure 91 Shows a side schematic view of a delivery system according to the configuration shown in Figure 90

[0114] Figure 92 Side partial cross-sectional view of the handle and the knob assembly is shown.

[0115] Figure 93 Shows a side schematic view of a delivery system according to the configuration shown in Figure 92 ​​​​

[0116] Figure 94 Shows a partially transparent side view of the handle and knob assembly.

[0117] Figure 95 Shows Figure 94 A side cross-sectional view of the handle and knob assembly shown in

[0118] Figure 96 Shows Figure 94 A perspective view of the alignment features of the knob assembly shown in

[0119] Figure 97 Shows Figure 94 A side cross-sectional view of the handle and knob assembly shown in

[0120] Figure 98 Shows Figure 94 A side cross-sectional view of the handle and knob assembly shown in

[0121] Figure 99 Shows a perspective view of the retraction tether adapter.

[0122] Figure 100 Shows the handle and knob assembly using the retraction tether adapter as shown in Figure 99 A side cross-sectional view.

[0123] Figure 101 Shows the handle and knob assembly using the retraction tether adapter as shown in Figure 99 A side cross-sectional view.

[0124] Figure 102 Shows the handle and knob assembly using the retraction tether adapter as shown in Figure 99 A side cross-sectional view.

[0125] Figure 103 Shows the handle and knob assembly using the retraction tether adapter as shown in Figure 99 A side cross-sectional view.

[0126] Figure 104 Shows the handle and knob assembly using the retraction tether adapter as shown in Figure 99 A side cross-sectional view.

[0127] Figure 105 Shows Figure 62 A perspective cross-sectional view of the proximal portion of the handle of the delivery system shown in

[0128] Figure 106 Shows a side view of the nose cone.

[0129] Figure 107 Shows being advanced throughFigure 106 Side cross-sectional view of the guide wire of the nose cone shown in .

[0130] Figure 108 A side cross-sectional view of a guidewire sheath and spacer body is shown.

[0131] Figure 109 Shown Figure 108 A side cross-sectional view of a guidewire sheath and spacer body with a guidewire advanced through the spacer body.

[0132] Figure 110 A perspective view of the guidewire sheath and spacer body is shown.

[0133] Figure 111 Shown Figure 110 A side cross-sectional view of a guidewire sheath and spacer body with a guidewire advanced through the spacer body.

[0134] Figure 112 A side cross-sectional view of a guidewire sheath and spacer body is shown.

[0135] Figure 113 A side view of the guidewire sheath and spacer body is shown.

[0136] Figure 114 A side view of the guidewire sheath and spacer body is shown.

[0137] Figure 115 An end view of the spacer body is shown.

[0138] Figure 116 A side view of the guidewire sheath and spacer body is shown.

[0139] Figure 117 A side view of the guidewire sheath and spacer body is shown.

[0140] Figure 118 A transverse cross-sectional view of the elongated shaft of the delivery catheter is shown.

[0141] Figure 119 A transverse cross-sectional view of the elongated shaft of the delivery catheter is shown.

[0142] Figure 120 A perspective view of the stabilizer assembly is shown.

[0143] Figure 121 A perspective view of a prosthetic heart valve is shown.

[0144] Figure 122 Shown Figure 121 A distal or outflow end view of a prosthetic heart valve is shown in FIG.

[0145] Figure 123 shows Figure 121 a cross-sectional schematic view of the prosthetic heart valve shown in DETAILED DESCRIPTION

[0146] This specification and the drawings provide aspects and features of the present disclosure in the context of several examples of implants, such as prosthetic valves or replacement heart valves, and delivery systems and methods, which are configured for a patient's vasculature, such as for replacing an autologous heart valve within a patient. These examples may 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 features described herein can be applied to other medical implants, such as other types of prosthetics for other locations within the body, such as within arteries, veins, or other body cavities or locations. Additionally, specific features of the valves, delivery systems, etc. should not be considered limiting, and the features of any one example discussed herein can be combined with the features of other examples as needed and as appropriate. Although some of the examples described herein are described in connection with a trans-femoral artery delivery method, it should be understood that these examples can be used with other delivery methods, such as a trans-apical or trans-jugular method. Further, it should be understood that certain features described in connection with some examples can be combined with other examples, including examples described in connection with different delivery methods.

[0147] Figure 1 An example of a delivery system 10 is shown. The delivery system 10 can be used to deploy an implant as disclosed herein or another form of implant. The features of implants or prosthetic heart valves that can be utilized are disclosed in U.S. Provisional Application No. 63 / 436,051, filed Dec. 29, 2022, and U.S. Provisional Application No. 63 / 533,458, filed Aug. 18, 2023, the entire contents of each of which are hereby incorporated by reference.

[0148] Implants, such as prosthetic heart valves, can be delivered to a subject's mitral or tricuspid annulus or other heart valve location in a variety of ways, such as by open surgery, minimally invasive surgery, and percutaneous or transcatheter delivery through the subject's vasculature. An exemplary trans-femoral artery method is further described in U.S. Patent Publication No. 2015 / 0238315, published Aug. 27, 2015, the entire contents of which are hereby incorporated by reference in their entirety. Although the delivery system 10 is described in connection with a percutaneous delivery method, and more specifically a trans-femoral artery delivery method, it should be understood that the features of the delivery system 10 can be applied to other delivery methods, including delivery systems for a trans-apical delivery method.

[0149] Delivery system 10 can be used to deploy a prosthesis, such as a replacement heart valve, to a location within a subject's body. The delivery system 10 can include a plurality of components, devices, or sub-assemblies. As Figure 1 shown, the delivery system 10 can include an elongate catheter, delivery catheter, or delivery device 12 and a stabilizer assembly 14, as well as other components as needed. The delivery device 12 can include an elongate shaft or shaft assembly 18 and a housing in the form of a handle 16. The housing can be at the proximal portion of the elongate shaft or shaft assembly 18. The shaft assembly 18 can include one or more shafts. According to examples herein, a plurality of shafts can be provided, but in an example, a single shaft can be utilized.

[0150] The elongate catheter or delivery device 12 can be pre-attached to an implant (e.g., a valve prosthesis or replacement heart valve), and the delivery device 12 can be configured to facilitate delivery of the implant to a desired target location (e.g., the mitral or tricuspid heart valve annulus, and other locations) and implantation at that target location. The implant can be pre-attached within the distal portion of the shaft assembly 18 during manufacture or assembly and removably tethered to one or more retention members of the shaft assembly 18. The pre-loaded delivery device 12 can then be packaged, sterilized, and transported for use by one or more clinicians. According to several examples, the delivery device 12 can be ready for use after removal from its packaging and may not require a clinician to load the implant. In an example, the delivery device 12 can be flushed and loaded prior to use.

[0151] The elongate catheter or delivery device 12 can include an elongate shaft or shaft assembly 18 that includes a proximal portion and a distal portion, and the elongate catheter or delivery device has a handle 16 coupled to the proximal portion of the shaft assembly 18. The elongate catheter or delivery device 12 can be used to hold an implant (e.g., a prosthesis, replacement heart valve) for advancement through the vasculature to a treatment location. The elongate shaft or shaft assembly 18 can be used to advance the implant through a patient's vasculature to an implantation site (e.g., an autologous atrioventricular valve). In some examples, the elongate shaft or shaft assembly 18 can hold at least a portion of an expandable implant (e.g., a prosthesis, replacement heart valve) in a compressed state for advancement of the implant within the body. The elongate shaft or shaft assembly 18 can then be used to allow controlled expansion of the implant at a desired implantation location (e.g., a treatment location). In some examples, the shaft assembly 18 can be used to allow sequential controlled expansion of the implant as discussed in detail below.

[0152] The elongate shaft or shaft assembly 18 of the delivery device 12 may include one or more shafts. In an example, multiple shafts may be provided. The multiple shafts may include one or more sub-assemblies or shafts, such as an outer sheath shaft or sub-assembly 20, a guide rail shaft or sub-assembly 22, a middle shaft or middle shaft sub-assembly 24, a tether assembly or sub-assembly 26, a release assembly or sub-assembly 28, and / or a nose cone shaft or sub-assembly. In some examples, the shaft assembly 18 of the elongate catheter or delivery device 12 may not have all of the sub-assemblies or shafts disclosed herein. The delivery device 12 may include multiple concentric shafts, sub-assemblies, or lumens. The individual lumens or shaft sub-assemblies will be described starting from the outermost layer. In some examples, the radial order of the shafts or sub-assemblies described may be different from that discussed.

[0153] Figure 2 A perspective view of an example of the outer sheath shaft or sub-assembly 20 of the elongate catheter or delivery device 12 of the delivery system 10 is shown. The outer sheath shaft or sub-assembly 20 forms a radially outer covering or sheath to cover and surround an implant holding region for holding an implant and to prevent at least a portion of the implant (e.g., a replacement heart valve or valve prosthesis) from radially expanding until ready for implantation. Specifically, the outer sheath sub-assembly 20 may prevent the distal portion of the implant from radially expanding.

[0154] The outer sheath shaft or sub-assembly 20 may include an outer proximal shaft 30 having a proximal portion that may be operatively coupled (e.g., via a threaded outer sheath adapter 32 at the proximal portion of the outer sheath shaft or sub-assembly 20) to the balloon actuator or knob 34 of the handle 16 (which may be the farthest distal actuator or knob as shown in Figure 24 and 25 ), such that rotation of the balloon knob 34 causes proximal and distal movement (e.g., clockwise and counterclockwise rotation) of the outer sheath sub-assembly 20 in the form of translation. A balloon sub-assembly 36 may be attached to the distal end of the outer proximal shaft 30. The balloon of the balloon sub-assembly 36 is at the distal portion of the elongate shaft or shaft assembly 18 and is adapted to maintain a prosthetic heart valve in a compressed state. The components of the outer sheath shaft or sub-assembly 20 may form the outermost lumen for other shafts or sub-assemblies to pass through.

[0155] The outer proximal shaft 30 may be a tube formed of plastic, but may also be formed of a metal hypotube or other material. The outer proximal shaft 30 may include an outer sheath or liner made of fluorinated ethylene propylene (FEP) material, polytetrafluoroethylene (PTFE) material, ePTFE material, or other polymeric material to smooth the outer surface of the outer proximal shaft 30 and provide hemostasis. The outer proximal shaft 30 may include a connector (e.g., a flexible return member) at its distal end to facilitate connection or coupling to the balloon sub-assembly 36. At least a portion of the outer proximal shaft 30 may include a laser-cut hypotube having a flexible pattern (such as a general flexible pattern). An interrupted helical pattern or interrupted coil may be utilized.

[0156] Figure 3 A side cross-sectional view of a balloon assembly 36 is shown. The balloon assembly 36 can include a distal hypotube or balloon stent 38, an inner liner inside the hypotube 38, a distal balloon tip 100, and one or more outer liners or sheaths 102 surrounding the hypotube 38. The one or more outer liners or sheaths 102 can include PEBAX or other suitable polymer or thermoplastic elastomeric materials, such as polytetrafluoroethylene (PTFE) or expanded polytetrafluoroethylene (ePTFE). The inner liner can include PTFE, which can be pre-compressed before being applied to the interior of the hypotube 38. The distal balloon tip 100 can include an atraumatic tip adapted to act as a funnel to facilitate retrieval (e.g., crimping) of a valve prosthesis or other implant. The distal balloon tip 100 can be constructed of polyetheretherketone (PEEK) or other thermoplastic, polymeric, or metallic material. The distal balloon tip 100 can be loaded with a radiopaque material (e.g., 5-40% barium sulfate loading) to facilitate detection (e.g., made fluorescent) under radiographic imaging (e.g., fluoroscopy). The distal balloon tip 100 can fit within the open distal end of the hypotube 38.

[0157] Figure 4 A perspective view of a distal hypotube or balloon stent 38 is shown. The balloon stent 38 can be formed from one or more materials such as PTFE, ePTFE, polyether block amide (Pebax®), polyetherimide (Ultem®), PEEK, polyurethane, nitinol, stainless steel, and / or any other biocompatible material. The balloon stent 38 is preferably flexible while still maintaining a sufficient degree of radial strength to maintain an implant (e.g., a replacement valve) within the balloon stent 38 without significant radial deformation that could increase friction between the balloon stent 38 and the implant contained therein. The balloon stent 38 also preferably has sufficient column strength to resist buckling, as well as sufficient tear resistance to reduce or eliminate the possibility of tearing of the implant and / or damaging the balloon stent 38. The proximal and / or distal ends of the distal hypotube or balloon stent 38 may include multiple laser cut windows 104 that are adapted to cause the proximal and / or distal ends to fluoresce and / or echo for visualization under certain imaging modalities (e.g., non-invasive ultrasound imaging or invasive fluoroscopic imaging). In several embodiments, due to the presence of the laser cut windows 104, separate radiopaque elements or members are not added to the hypotube 38 to facilitate imaging. The laser cut windows 104 may also facilitate bonding of the outer sheath 102 to the balloon stent 38 and inner liner by allowing glue or other adhesive to flow through the laser cut windows 104. One or more layers of connecting members made of PEBAX or other suitable material may surround the laser cut windows 104 to facilitate coupling the hypotube or balloon stent 38 to the distal balloon tip 100.

[0158] The hypotube 38 can be formed from plastic or metal. In some embodiments, the hypotube 38 can be a metal hypotube. If metal, the metal material of the hypotube 38 can include cobalt-chromium alloy, stainless steel, titanium, or a metal alloy such as nickel-titanium alloy. The coil configuration or cut pattern of the proximal outer shaft 30 and / or hypotube 38 can allow the proximal shaft 30 to follow the guide shaft or subassembly 22 in any desired direction. The cut pattern (e.g., cuts per revolution, pitch, ridge distance) of the proximal outer shaft 30 and / or hypotube 38 can be modified to control tensile strength, compressive strength, flexibility, and torque resistance. For example, the cuts per revolution can range from 1.5 to 5.5, the pitch can range from 0.005" to 0.15", and the ridge distance can range from 0.015" to 0.125". The hypotube 38 can advantageously provide both tension and compression. The one or more outer liners or sheaths 102 can allow for greater flexibility of the balloon assembly 36. The balloon hypotube 38 can be curved in a variety of directions. In some embodiments, the distal end of the outer liner or sheath 102 can be positioned proximal to the distal end of the hypotube 38 .

[0159] The balloon assembly 36 can have a diameter similar to that of the outer proximal shaft 30 or a different diameter. In some examples, the balloon assembly 36 has a uniform or substantially uniform diameter along its length. In some examples, the balloon assembly 36 can be 28 French or smaller (e.g., 27 French). In some examples, the balloon assembly 36 can include a larger diameter distal portion and a smaller diameter proximal portion. The balloon assembly 36 or sac can be configured to hold an implant (e.g., a valve prosthesis) in a compressed position (e.g., in a closed position) within the balloon assembly 36. Figure 5 2019 / 0008640 and U.S. Publication No. 2019 / 0008639 (which disclosures are hereby incorporated by reference herein) may be included in the balloon subassembly 36.

[0160] The outer sheath shaft or subassembly 20 is configured to be individually movable or slidable relative to the other shafts or assemblies by operation of a control mechanism. The control mechanism may include an actuator in the form of a capsule knob 34 (in Figure 24(in the middle marking). The balloon knob 34 can be rotated to move or slide the outer sheath shaft or sub-assembly 20. Additionally, the outer sheath sub-assembly 20 can slide distally and proximally relative to the guide rail sub-assembly 22 together with the central shaft sub-assembly 24, the tether assembly 26, the release assembly 28, and / or the nose cone sub-assembly. The control mechanism can be configured to control the deflection of a portion of the elongate catheter or delivery device 12 of the delivery system 10, including the deflectable portion of the elongate catheter or delivery device 12.

[0161] Figure 5 Schematically shows how at least a portion of the length of one or more components (e.g., the inner lining 108) of the balloon sub-assembly 36 can include excess material such that the balloon sub-assembly 36 includes a built-in slack along a portion of its length (e.g., a portion of the length near the implant holding region 106) to facilitate flexible bending of the balloon sub-assembly 36 (e.g., navigating sharp turns within the heart or the vasculature surrounding the heart).

[0162] Figure 6 Shows Figure 1 A perspective view of the guide rail shaft or sub-assembly 22 or the elongate shaft of the elongate catheter or delivery device 12 of the delivery system 10. Figure 6 Shows in relation to Figure 2 Substantially the same view, but with the outer sheath sub-assembly 20 removed, thereby exposing the guide rail sub-assembly 22.

[0163] Figure 7 Further shows cross-sectional views of the proximal and distal portions of the guide rail sub-assembly 22 to observe the pull wires or pull tethers facilitating the manipulation of the guide rail sub-assembly 22. The guide rail sub-assembly 22 can include a guide rail shaft 110 (or guide rail), which is generally attached (and operatively coupled) to the handle 16 at its proximal end. The guide rail shaft 110 can be composed of a guide rail proximal shaft 112 directly attached to the handle 16 at the proximal end and a guide rail hypotube 114 attached to the distal end of the guide rail proximal shaft 112 (e.g., via a connector, an annular structure, or an insert 116). The guide rail sub-assembly 22 is via a primary flexure adapter 118A at the proximal portion of the guide rail sub-assembly 22, which is via one or more distal pull tethers or wires 120A (at Figure 7The rail subassembly 22 is operably coupled to the handle 16 via a secondary flexure adapter 118B at the proximal portion of the rail subassembly 22 (which controls the anterior-posterior trajectory of the distal portion of the rail subassembly 22 via one or more proximal pull tethers or wires 120B), and via a rail adapter 119 at the proximal portion of the rail subassembly 22 (which includes a side needle-free injection port to facilitate flushing and degassing functions). The rail proximal shaft 112 may include an interrupted helical cut pattern along a majority of its length to facilitate compression. The rail hypotube 114 may also include an atraumatic rail tip 122 at its distal tip. The atraumatic rail tip 122 may not include a slit and may be configured to extend up to 1 inch beyond the distal end of the rail hypotube 114 and not be inserted into the outer shaft subassembly 20 to avoid friction and fatigue and extend use time. These components of the rail subassembly 22 may form a lumen through which the other internal subassemblies pass.

[0164] Figure 7 Shown Figure 6 A side cross-sectional view of the guide shaft or subassembly 22. Figure 7 As shown in FIG, one or more pull wires 120 are attached to the inner surface of the guide hypotube 114, which can be used to apply force to the guide hypotube 114 and manipulate the guide subassembly 22. The pull wires 120 can be adjusted from the primary and secondary flexure knobs 124A, 124B ( Figure 24 and 25 ) extends distally to the guide hypotube 114. In some instances, the pull wire 120 can be attached at different longitudinal locations on the guide hypotube 114, thereby providing multiple bending locations in the guide hypotube 114, thereby allowing multi-dimensional manipulation. For example, the guide hypotube 114 can provide a primary bend or flexure along a medial / lateral trajectory and a secondary bend or flexure along an anterior / posterior trajectory. Alternative bending directions can be provided for deployment to the tricuspid valve. The guide hypotube 114 can form a curved portion for bending the slender shaft or other axis of the shaft assembly 18.

[0165] The guide hypotube 114 may include multiple circumferential grooves (e.g., laser-cut into the hypotube) to facilitate bending and flexibility. The guide hypotube 114 can generally be divided into several distinct sections. At the proximal end is an uncut (or unslotted) hypotube section corresponding to the location of the insert 116. Moving distally, the next section is the proximal slotted hypotube section 126P. This section includes multiple circumferential grooves cut into the guide hypotube 114. Typically, two grooves are cut around each circumferential location, forming almost half the circumference. Thus, two main trunks are formed between the grooves extending along the length of the guide hypotube 114. This is the section that can be guided by the proximal puller wire 120B. Further distally, the proximal puller wire 120 is connected, thus avoiding grooves. This section is just distal to the proximal slotted section 126P and may correspond to the location of the insert or puller wire connector 128.

[0166] The distal slotted hypotube segment 126D follows the proximal puller wire connection area distally. This segment is similar to the proximal slotted hypotube segment 126P, but significantly more slots may be cut over an equal length. Thus, the distal slotted hypotube segment 126D may provide easier bending and increased bending angles than the proximal slotted hypotube segment 126P. In some instances, the proximal slotted segment 126P may be configured to undergo a bend of approximately 90 degrees with a radius of half an inch, while the distal slotted segment 126D may undergo a bend of approximately 180 degrees with a radius of half an inch. Additionally, as Figure 6 and 7 As shown in FIG, the spine of the distal slotted hypotube segment 126D is circumferentially offset from the spine of the proximal slotted hypotube segment 126P. As a result, the two segments will achieve different bending modes, thereby allowing three-dimensional manipulation of the rail subassembly 22. In some examples, the spines may be offset by 30, 45, or 90 degrees, but the specific offset is not limiting. The distal-most end of the distal slotted hypotube segment 126D is the distal puller wire connection area, which is also the non-slotted section of the rail hypotube 114.

[0167] In some examples, one distal puller wire 120A may extend to the distal section of the rail hypotube 114 (e.g., to the rail tip 122), and two proximal puller wires 120B may extend to the proximal section of the rail hypotube 114; however, other numbers of puller wires may be used, and the specific number of puller wires is not limiting. For example, two distal puller wires 120A may extend to a distal location, and a single proximal puller wire 120B may extend to a proximal location. In some examples, a ring-like structure or insert (referred to as a puller wire connector) attached to the interior of the rail hypotube 114 may serve as an attachment location for the proximal puller wire 120B (such as insert 128). In some examples, the puller wires 120 may be directly connected to the inner surface of the rail hypotube 114.

[0168] The distal pull wire 120A can be connected generally at the distal end of the guidewire hypotube 114 (either on its own or through the guidewire tip connector 122). The proximal pull wire 120B can be connected (either on its own or through the insert 128) at a location along the guidewire hypotube 114 starting from the proximal end at approximately one-quarter, one-third, or one-half of the length. In some instances, the distal pull wire 120A can pass through a small-diameter pull wire lumen (e.g., a tube, a hypotube, a cylinder) attached inside the guidewire hypotube 114. This can prevent the pull wire 120 from pulling on the guidewire hypotube 114 at the location near the distal connection. Additionally, the lumen can include compression coils to reinforce the proximal portion of the guidewire hypotube 114 and prevent unnecessary bending. Thus, in some instances, the lumen is located only on the proximal portion (e.g., the proximal half) of the guidewire hypotube 114. In some instances, each distal pull wire 120A can use multiple lumens, such as longitudinally spaced or adjacent lumens. In some instances, each distal wire 120A uses a single lumen. In some instances, the lumen can extend into the distal portion (e.g., the distal half) of the guidewire hypotube 114. In some instances, the lumen is attached to the outer surface of the guidewire hypotube 114. In some instances, no lumen is used. In some instances, one or more compression coils 130 extend from the insert 116 to the insert 128. The compression coils 130 can be configured to bypass the load over the length between the distal primary flexure point and the proximal secondary flexure point. The compression coils 130 contribute to independent flexure planes such that when one flexure plane needs to flex, the two flexure planes are not activated. The compression coils 130 can allow the proximal slotted hypotube section 126P to remain rigid for a specific bend of the distal slotted hypotube section 126D. The compression coils 130 can isolate the force, so that only the primary flexure portion is flexed.

[0169] For a pair of proximal pull wires 120B, the wires may be spaced approximately 180º from each other to allow manipulation in two directions. Similarly, in the case of using a pair of distal pull wires 120A, the wires may be spaced approximately 180º from each other to allow manipulation in two directions. In some instances, a pair of distal pull wires 120A and a pair of proximal pull wires 120B may be spaced approximately 90º from each other. Opposing wires may be used to provide a flexure resistance mechanism. In some instances, a pair of distal pull wires 120A and a pair of proximal pull wires 120B may be spaced approximately 0º from each other. However, other positions of the pull wires may be used, and the specific position of the pull wires is not limiting. In some instances, the distal pull wires 120A may pass through lumens attached within the lumen of the guide rail hypotube 114. This may prevent axial forces on the distal pull wires 120A from creating bending in the proximal section of the guide rail hypotube 114. The guide rail subassembly 22 is configured to be slidable over the radially inner subassembly. When the guide rail hypotube 114 bends, it presses against the other subassemblies to cause them to bend as well, and thus the other subassemblies of the delivery device 12 may be configured to be manipulated with the guide rail subassembly 22 as a cooperating single unit, thus providing full manipulability at the distal end of the delivery device 12. The guide rail hypotube 114 is adapted to bend in a first direction in a first plane (the deflection plane of the distal slotted hypotube section 126D) and in a second direction in a second plane (the deflection plane of the proximal slotted hypotube section 126P), where the second plane extends transversely or perpendicularly relative to the first plane. Additional structural and operational details of the guide rail subassembly, such as those described in connection with the guide rail assemblies in U.S. Publication Nos. 2019 / 0008640 and 2019 / 0008639, which are hereby incorporated by reference herein, may be incorporated into the guide rail subassembly 22.

[0170] Figure 8 and 9 Schematically shows how the outer compression coil 130A and the proximal pull wire 120B1 may have a longer length than the inner compression coil 130B and the proximal pull wire 120B2 of the guide rail subassembly 22, such that they do not occupy the same space and facilitate easy bending in one direction and reduce lumen blockage during bending.

[0171] Moving radially inward, the next subassembly is the central shaft or central shaft subassembly 24. ​ A perspective view of the central shaft subassembly 24 of the delivery device 12 of the delivery system 10 is shown. ​A side view is shown. The midshaft subassembly 24 can include a distal midshaft hypotube 132 that is typically attached at its proximal end to a proximal shaft 134, which in turn can be attached at its proximal end to the handle 16 (e.g., via a midshaft adapter 136 at the proximal portion of the midshaft subassembly 24), and a distal pusher 138 at the distal end of the midshaft hypotube 132. These components of the midshaft subassembly 24 can form a lumen through which other internal subassemblies pass.

[0172] The mid-axis subassembly 24 can be positioned within the lumen of the rail subassembly 22. The mid-axis hypotube 132 can be formed from a metal alloy (e.g., cobalt-chromium alloy, nickel-chromium-cobalt alloy, nickel-cobalt-based alloy, nickel-titanium alloy, stainless steel, and titanium). The mid-axis hypotube 132 can include an interrupted spiral cut pattern. ​ Shown with ​ A similar view, but with the rail subassembly 22 removed, thereby exposing the bottom bracket subassembly 24 .

[0173] Similar to other subassemblies, the mid-axis hypotube 132 and / or the mid-axis proximal tube 134 may comprise a tube, such as a hypodermic tube or a hypotube (not shown). The tube may be made from any of a number of different materials, including nitinol, stainless steel, and medical-grade plastic. The tube may be a single piece or multiple pieces connected together. Using a tube made from multiple pieces allows the tube to provide different properties, such as stiffness and flexibility, along different sections of the tube. The mid-axis hypotube 132 may be a metal hypotube. The mid-axis hypotube 132 may have multiple slots / orifices cut into the hypotube. In some examples, the cut pattern may be the same throughout. In some examples, the mid-axis hypotube 132 may have different sections with different cut patterns. The mid-axis hypotube 132 may be covered or encapsulated with a layer of ePTFE, PTFE, or other material, such that the outer surface of the mid-axis hypotube 132 is generally smooth. At least a portion of the length of the mid-axis proximal tube 134 may be covered with heat shrink tubing or packaging.

[0174] Pusher 138 can be configured to radially retain a portion of an implant (e.g., a prosthesis), such as the proximal end of the implant, in a compressed configuration. Pusher 138 can compress the inlet end portion of a prosthetic heart valve. For example, pusher 138 can be a ring or cover configured to radially cover the proximal end portion of the implant (e.g., the suture eyelet portion). Pusher 138 can also be considered part of implant retention region 106 and can be located proximal to implant retention region 106. Pusher 138 can include a frustoconical or cup-shaped shape that is riveted or fastened on opposite sides to the distal end of the midshaft hypotube 132. Pusher 138 can be formed from PEEK, a ferrous material, platinum-iridium, or other fluorescent materials to facilitate radiographic imaging. The midshaft subassembly 24 can be configured to be fixed relative to the handle. In some examples, the midshaft subassembly 24 can slide independently of the other subassemblies. The mid-shaft adapter 136 may be operably coupled to the depth knob 140 ( ​ ). A depth knob 140 can be used to achieve ventricular / atrial movement of the shaft of the elongated catheter within the heart. Additional structural and operational details of the mid-shaft subassembly 24, such as those described in conjunction with the intermediate assemblies in U.S. Publication Nos. 2019 / 0008640 and 2019 / 0008639 (which disclosures are hereby incorporated by reference herein), can be incorporated into the mid-shaft subassembly 24.

[0175] refer to ​ , a tether assembly 26 can be used with the delivery system 10. The tether assembly 26 can comprise a portion of the elongated shaft 18 of the delivery device 12. In examples, the tether assembly 26 can extend within the mid-shaft subassembly 24 and can, for example, extend within the lumen of the mid-shaft hypotube 132. The tether assembly 26 extends through the elongated shaft of the delivery device. The mid-shaft subassembly 24 can include a sheath that extends over the tether assembly 26. Other sheaths of the delivery system 10 can include a sheath that extends over the tether assembly 26. In examples, the tether assembly 26 can extend outside the mid-shaft subassembly 24 or any other portion of the delivery device 12, as desired.

[0176] The tether assembly 26 may include a plurality of coupling tethers 142, each of which may be configured to be coupled to an implant. The coupling tethers 142 may be positioned at a distal portion of the tether assembly 26. The tether assembly 26 may include a tether manifold 144 for coupling to the plurality of coupling tethers 142. The tether assembly 26 may include a flexible retention tether 146 that may be coupled to the tether manifold 144 and may extend proximally from the tether manifold 144. The flexible retention tether 146 may extend proximally to a proximal portion 148 that may be coupled to an adapter 150 or other component for coupling to the handle 16.

[0177] The flexible retention tether 146 can have various forms and can include, in an example, a wire or suture. Other forms of the flexible retention tether 146 can be used. The use of a wire or suture can impart flexibility to the retention tether 146, which can allow the flexible retention tether 146 to more easily deflect or flex as the elongate shaft 18 deflects or flexes. A polymer extrudate can also be utilized. For example, a portion of the elongate shaft 18, such as a guide rail shaft or subassembly 22, can form a bend in the elongate shaft 18. Thus, the elongate shaft 18 can have a deflectable portion configured to deflect transverse to the longitudinal axis of the elongate shaft 18. The flexible retention tether 146 can be configured to deflect at the deflectable portion. Relative to a tubular or hypotube shaft that can extend along the elongate shaft 18, the flexible retention tether 146 can have increased flexibility and reduced stiffness.

[0178] The flexible retention tether 146 can extend distally to a distal portion 152 of the flexible retention tether 146. The flexible retention tether 146 can be configured to longitudinally extend along the elongate shaft 18 from the handle 16 (labeled in ​ FIG.) to the distal end of the elongate shaft 18. The flexible retention tether 146 extends proximally from the tether manifold 144 for engagement with a tether actuator.

[0179] ​ A close-up view of the distal portion 152 of the flexible retention tether 146 is shown. A cross-sectional view of the tether manifold 144 is shown.

[0180] The tether manifold 144 is configured to collect the plurality of coupling tethers 142. The tether manifold 144 can couple the plurality of coupling tethers 142 to the distal portion 152 of the flexible retention tether 146. As ​ shown, the tether manifold 144 can include a loop of material of the flexible retention tether 146 and a sheath 149 extending over the loop of material. The tether manifold 144 can include a loop of material that includes the wire of the flexible retention tether 146 or can have another configuration in an example. For example, the tether manifold 144 can include a loop of suture material that includes the flexible retention tether 146.

[0181] The sheath 149 may include a tube that can hold the plurality of coupling tethers 142 to the loops of the manifold 144. The tube may include a shrink tube or other form of tube that can be placed on the loops of the manifold. The sheath 149 may be flexible. Thus, a flexible and conformable configuration of the manifold 144 can be produced. In an example, the material may be melted or reflowed at the connection of the coupling tether 142 and the manifold. The material may include a polymer material that can be melted or reflowed (e.g., PEBAX, HDPE, LDPE, etc.). In an example, a combination of such materials and the sheath may be utilized. In an example, the length of the sheath 149 may be extended to improve the ability of the tether assembly 26 to be pushed through the lumen of the tube of the sheath (e.g., the lumen of the central axis). In an example, the tether manifold may have other configurations.

[0182] The plurality of coupling tethers 142 may extend from the tether manifold 144. The plurality of coupling tethers 142 may be configured to be coupled to the implant in various ways. For example, each of the plurality of coupling tethers 142 may be configured to pass through an opening in a portion of the implant. For example, ​ A loop portion of the plurality of coupling tethers 142 passing through corresponding eyelets of the implant is shown. The plurality of coupling tethers 142 may be coupled to the implant in other ways as needed.

[0183] In an example, the plurality of coupling tethers 142 may be flexible. Each of the plurality of coupling tethers 142 may include a suture or other form of flexible material. In an example, each of the plurality of coupling tethers 142 may include a loop, wherein the loop is configured to pass through an opening in a portion of the implant. For example, ​ A loop extending through an eyelet of the implant is shown.

[0184] In an example, the plurality of coupling tethers 142 may include a continuous suture. For example, referring to ​ , the plurality of coupling tethers 142 may include loops formed by a continuous suture that loops around the arm 154 of the tether manifold 144 multiple times, wherein the arm 154 forms the loop. For example, a first length 156a of the tether 142 may loop around the arm 154 to produce a second length 156b of the tether 142. The second length 156b may loop at its distal end to form a distal loop and produce a third length 156c of the tether 142. The third length 156c may loop around the arm 154 to produce a fourth length 156d. The lengths may be looped iteratively to produce a desired number of distal loops for coupling to the implant. The plurality of coupling tethers 142 may include a continuous suture length. In an example, the sheath 149 may be positioned above the proximal loop of the coupling tether 142 to secure the proximal loop to the arm 154. In an example, the arm 154 may include a wire. Other configurations may be used in an example.

[0185] For example, ​ An example is shown in which the flexible retention member or tether 160 is woven or braided. The flexible retention tether 160 may include a plurality of sutures woven or braided into a larger suture. The tether manifold 162 may include a separation of the plurality of coupling tethers 164 from the flexible retention tether 160. The plurality of coupling tethers 164 may be woven or braided from the flexible retention tether 160 and may include a woven or braided sub - portion of the flexible retention tether 160. The plurality of coupling tethers 164 may include loops woven or braided with the tether manifold 162. The braid may include a cylindrical braid or a flat braid, or may have another configuration in the example.

[0186] ​ An example is shown in which the tether manifold 170 includes a knot that couples the flexible retention tether 172 to the plurality of coupling tethers 174. ​ and 16 The tether assembly of may be entirely based on sutures and may thus remain flexible along the length of the tether assembly. In an example, a combination of polymer or sleeve or wire may be provided to improve the ability of the tether assembly 26 to be pushed through the lumen of the sleeve.

[0187] The plurality of coupling tethers may be positioned at the distal portion of the elongate shaft 18 for connection to the implant. For example, ​ An example is shown of the plurality of coupling tethers 142 extending from the lumen of the central shaft 24 and particularly from the lumen of the pusher 138 of the central shaft 24. The plurality of coupling tethers 142 may be positioned for connection to the implant.

[0188] For example, ​ An example is shown of the coupling configuration of the plurality of coupling tethers 142 with the implant 176. The coupling tether 142 may extend through the eyelets of the implant 176 for connection to the implant. The coupling tether 142 may extend radially outward from the lumen of the central shaft.

[0189] In an example, a plurality of tether assemblies 26 may be utilized. For example, each tether assembly may utilize one or more of the coupling tethers 142. Each of the tether assemblies 26 may be independently controlled for selectively controlling implant expansion. For example, a first portion of the implant may expand before a second portion, or may be retracted to control the position of the anchor. A controlled placement of the anchor may be produced. The plurality of tether assemblies 26 may have other beneficial results.

[0190] In an example, a release assembly 28 may be used to release the plurality of coupling tethers 142 from the implant 176. For example, ​A side view of release assembly 28 is shown. Release assembly 28 can include one or more release tethers 180. In an example, release tether 180 can be coupled to a release tether manifold 182. In an example, release tether manifold 182 can be coupled to a retractable tether 184. In an example, release tether 180 can include a flexible tether.

[0191] The retractable tether 184 can extend proximally to a proximal portion 186. In an example, the proximal portion 186 can be coupled to an adapter 189. The adapter 189 can be configured to be coupled to a release actuator 191 (in an example). ​ ) or other components of the delivery system. The retractable tether 184 can be flexible and, in examples, can include a thread or suture. The retractable tether 184 can include a filament that can be configured to extend along the elongated shaft 18 of the delivery device 12. In examples, the retractable tether 184 can extend within the midshaft subassembly 24 and can, for example, extend within the lumen of the midshaft hypotube 132. For example, the midshaft subassembly 24 can include a sheath that extends over at least a portion of the release assembly. Other sheaths can be utilized as desired. In examples, the retractable tether 184 can extend externally of the midshaft subassembly 24 or externally of any other portion of the delivery device 12, as desired.

[0192] The release assembly 28 can be configured to be flexible and deflectable with the elongated shaft 18 of the delivery device 12. For example, at least a portion of the release assembly 28 can be configured to deflect at a deflectable portion of the elongated shaft 18.

[0193] The retractable tethers 184 can extend to a distal portion 188. A release tether manifold 182 can be positioned at the distal portion 188. The release tether manifold 182 can include a collection of release tethers 180.

[0194] In an example, the use of manifold 182 can be eliminated, and one or more of release tethers 180 can extend along the length of elongated shaft 18. Thus, the release assembly can include one or more of release tethers 180 in an example, which can be used to release the plurality of coupling tethers 142 from implant 176. In an example, only one release tether 180 can be used (wherein a single release tether is threaded through multiple loop portions).

[0195] In an example, one or more of the release tethers 180 can be used to extend through one or more of the loop portions of the coupling tethers 142 to secure the implant to the loop portions. ​Shows one of the release tethers 180a that extends through the respective loop portions 188a, 188b, 188c of the respective coupling tethers 142a, 142b, 142c. Since the loop portions 188a, 188b, 188c extend through the eyelets of the implant, the release tether 180a can hold the implant to the loop portions 188a, 188b, 188c via the loop portions 188a, 188b, 188c. In an example, a single release tether 180a can pass through multiple loop portions. In an example, a single release tether 180a can pass through a single loop portion (e.g., a one-to-one correspondence between the release tether and the loop portion).

[0196] The release tether 180 can have various forms and can include sutures, cables, wires, monofilaments, tapes, or extrusions. Other forms of release tethers 180 can be used in an example.

[0197] In an example, a single release tether can be used to couple to the loop portions of the coupling tether. In an example, multiple release tethers can be used. For example, ​ Shows a configuration in which three release tethers are used, each release tether configured to extend through three loop portions. One or more release tethers can be configured to extend circumferentially between multiple loop portions of the coupling tether. More or fewer release tethers can be used as needed. In an example, a sheath or material for melting or reflow can be utilized at the release tether manifold 182. In an example, knots, or weaving, or braiding of the release tether can be utilized. Other forms of connection at the release tether manifold 182 can be utilized.

[0198] Reference ​ , the end 190 of the release tether can include a free end that can be retracted from the loop portions 188a, 188b, 188c to release the implant from the loop portions 188a, 188b, 188c. The retracted portion 192 or proximal portion of the release tether can extend to the retractable tether 184 for retraction from the loop portions 188a, 188b, 188c. The retracted portion 192 can extend radially inwardly to a holding sheath of the release assembly, which can include the central axis 24, or can include another sheath in an example.

[0199] For example, ​ and 22 Shows a retraction sequence in which the release tether 180a can be retracted from the loop portions 188a, 188b, 188c. For example, ​Illustrated is that the retracted portion 192 has been retracted, where the end 190 is withdrawn from the loop portion 188a. Accordingly, the loop portion 188a can be released from the eyelet 193a. The retracted portion 192 can continue to retract to release the remaining loop portions 188b, 188c from the respective eyelets 193b, 193c. Other release tethers can be released from the respective loop portions in a similar manner.

[0200] For example, ​ Illustrated is the loop portion of the coupling tether 142 released from the implant. The implant can be in an implanted or deployed configuration and positioned at an implantation site, such as an autologous heart valve site.

[0201] In an example, the route of the coupling tether can vary. For example, the coupling tether can pass through multiple eyelets of the implant (e.g., first through an eyelet in the outer valve frame and then through an eyelet in the inner frame). The release tether can lock the coupling tether at its most distal connection. When the release tether retracts, the coupling tether can be freely pulled through and separated from the two valve eyelets. Other forms of routing can be utilized.

[0202] The release assembly 28 can be used to hold the implant to the tether assembly 26 during the retrieval process of the implant. For example, if retrieval is desired, the tether assembly 26 can retract the implant into the central axis 24. The release assembly 28 can hold the implant to the tether assembly 26 during such a process.The release assembly 28 can be actuated at the desired time for the final release of the implant at the implantation site.

[0203] ​ Illustrated is a perspective view of the housing or handle 16 of the delivery device 12. ​A side, cross-sectional view of handle 16 is shown. Handle 16 includes a control mechanism for moving one or more shafts of the elongated catheter. The control mechanism may include multiple actuators or actuator assemblies, such as rotatable knobs, that can manipulate various components of delivery system 10 (e.g., causing movement of corresponding shafts or subassemblies of shaft assembly 18). The distal end of handle 16 includes an actuator in the form of a balloon knob 34. Rotation of balloon knob 34 in one direction can cause proximal axial movement of outer sheath subassembly 20 to release the distal portion (e.g., the ventricular portion) of the implant from balloon subassembly 36 and deploy the implant. For example, balloon knob 34 may include a retraction mechanism for retracting the balloon or balloon subassembly 36 to release the implant from the balloon. Rotation of balloon knob 34 in the opposite direction causes distal movement of outer sheath subassembly 20 (including balloon subassembly 36) to retract, retrieve, or reinstall the implant within balloon assembly 36. The outer sheath subassembly 20 can translate independently of the other subassemblies in the delivery device 12. The distal end of the implant can be released first, while the proximal end of the implant can be held radially compressed within the pusher 138 of the midshaft subassembly 24.

[0204] Moving proximally, the handle 16 includes a stabilizer mounting area 200 adapted to interface with a clamp of a stabilizer assembly configured to control the medial / lateral position of the delivery device 12. Further proximally, an actuator is provided in the form of a primary flexure rail knob 124A and a secondary flexure rail knob 124B. Rotation of the primary flexure rail knob 124A causes deflection of the distal slotted hypotube segment 126D of the primary flexure portion or guide hypotube 114 to achieve a medial / lateral trajectory change. Rotation of the secondary flexure rail knob 124B causes deflection of the proximal slotted hypotube segment 126P of the primary flexure portion or guide hypotube 114 to achieve an anterior / posterior trajectory change. However, the number of flexure rail knobs 124A, 124B may vary depending on the number of puller wires used.

[0205] Proximate to the secondary flexure rail knob 124B is a depth knob 140 that controls the movement of the outer sheath subassembly 20, midshaft subassembly 24, tether assembly 26, release subassembly 28, and nose cone shaft or subassembly relative to the rail subassembly 22. In some configurations, the depth knob 140 may also cause the other subassemblies to move relative to the rail subassembly 22 as well.

[0206] Further proximal is an actuator in the form of a release actuator 191 or release knob. The release actuator 191 can be rotated proximally to apply tension to the release assembly during the implant deployment procedure. Retraction of the release assembly can release the implant from the tether assembly.

[0207] The most proximal knob is the nasal cone knob 202, rotation of which causes proximal and distal movement of the nasal cone subassembly. The nasal cone subassembly is the most radially inward subassembly and may include a nasal cone shaft having a distal end connected to the nasal cone.

[0208] ​ A schematic representation of a method of delivering to an autologous tricuspid valve is shown. As ​ shown, in one example, the delivery system 10 can be placed in the ipsilateral femoral vein 204 and advanced toward the right atrium 206. In an example, the method can start from the inferior vena cava (or from the superior vena cava).

[0209] ​ The delivery system 10 is shown extending from the ipsilateral femoral vein 204 to the right atrium 206. In the examples of the present disclosure, no guide wire is required to position the delivery system 10 in place, but in other examples, one or more guide wires can be used.

[0210] Thus, it may be advantageous for a user to be able to manipulate the delivery system 10 through complex regions of the heart in order to align the replacement tricuspid valve with the autologous tricuspid valve. This task can be performed with or without the guide wire of the system disclosed above. The distal end of the delivery system 10 can be advanced into the right atrium 206. Then, the user can manipulate the guide rail subassembly 22 to align the distal end of the delivery system 10 with the appropriate region. In addition, the user can twist the entire delivery system 10 to further manipulate and control the position of the delivery system 10. In a fully bent configuration, the user can then place the replacement valve in place. This can advantageously allow the replacement valve to be delivered to the in-situ implantation site, such as the autologous tricuspid valve.

[0211] ​ A schematic representation of the distal end of the delivery system 10 approaching the autologous tricuspid valve is shown. Before releasing the implant from the implant holding region, the distal end of the delivery system 10 can be positioned relative to the implantation site as needed.

[0212] ​ The implant can be shown released from the delivery system 10, with the tether assembly 26 coupled to the implant. The position of the anchor relative to the autologous valve leaflets can be determined, and if in the proper position, the implantation procedure can proceed.

[0213] ​ The implant in an expanded configuration is shown, with the tether assembly 26 coupled to the implant. The release assembly 28 can hold the tether assembly 26 to the implant in this configuration.

[0214] For example, the release assembly 28 can be used to release the tether assembly 26 from the implant.​ The release of the tether assembly 26 is shown. ​ The implant deployed in place is shown.

[0215] A similar deployment procedure can be used with the mitral valve as needed. For example, a transseptal puncture can be performed from the right atrium 206 (labeled in ​ to gain access to the left atrium 208. Then, the user can insert the curved delivery system 10 through the transseptal puncture and into the left atrium 208. Then, the user can further manipulate the delivery system 10 to create a greater bend in the guide rail subassembly 22. Then, the delivery system 10 can be advanced into the left atrium 208 and then towards the left ventricle 210. The implant can be deployed in a similar manner as shown in ​ .

[0216] In an example, the release assembly can be provided in the form of a disintegration assembly 212. The disintegration assembly 212 can be configured to connect to a portion 213 of one or more coupling tethers 215 and disintegrate the connection with the portion 213 to release the implant from the elongate shaft of the delivery system.

[0217] In an example, as shown in ​ , the disintegration assembly 212 can include a heating element 214. The heating element 214 can be configured to disintegrate the connection with the portion 213 of the one or more coupling tethers 215. For example, the heating element 214 can be configured to heat to melt, break, evaporate, corrode, dissolve, or otherwise disintegrate the connection with the portion 213 of the one or more coupling tethers 215. In an example, one or more electrical conduits 216a, 216b can be provided, which can transfer electrical energy through the heating element 214 to activate the heating element 214. In an example, the disintegration assembly 212 can have other forms.

[0218] The heating element 214 can be configured as a ring as shown in ​ , or can have other configurations in an example (e.g., a strip of material, a coil, one or more pins, one or more hooks, one or more terminals, etc.). The heating element 214 can include a heating wire configured to become hot when electrical energy (e.g., current) passes through the heating element 214, or can have another configuration in an example. The heating element 214 can be made of materials such as nichrome (i.e., an alloy of nickel and chromium), stainless steel, tungsten, an alloy of tungsten or platinum, a nickel iron chromium alloy, or a ceramic material (e.g., molybdenum disilicide), and other forms of materials. Other forms of heating elements (e.g., semiconductor or polymer heating elements) can be used in an example. In an example, the heating element can generate heat using other methods.

[0219] In an example, the heating element 214 can be configured to be positioned within a portion of one or more shafts of the elongate shaft or shaft assembly 18. For example, as shown in the exploded view of ​ , the heating element 214 can be positioned within the lumen of the central shaft or central shaft sub-assembly 24 (and correspondingly within the lumen of the outer sheath shaft or sub-assembly 20). The heating element 214 can particularly be positioned within the distal pusher 138 of the central shaft or central shaft sub-assembly 24. For example, the heating element 214 can be positioned inside the inner surface 218 of the distal pusher 138 (marked in ​ ). The heating element 214 can be positioned at the proximal portion of the distal pusher 138 or at another location (e.g., the distal portion) as needed. The heating element 214 can include a ring extending circumferentially inside the inner surface 218 of the distal pusher 138. The ring shape can provide a central opening 220 (marked in ​ ) for other components of the system to pass through (e.g., other sheaths or shafts or assemblies). Other configurations can be used in the example.

[0220] The one or more electrical conduits 216a, 216b can extend along the length of the elongate conduit or delivery device 12. The one or more electrical conduits 216a, 216b can each include respective distal portions 222a, 222b and proximal portions 224a, 224b (marked in ​ ). The distal portions 222a, 222b can be coupled to the heating element 214 at respective junctions 226a, 226b (marked in ​ ). The proximal portions 224a, 224b can be coupled to a power source 228 (marked in ​ ). The one or more electrical conduits 216a, 216b can extend along the length of the elongate shaft or shaft assembly 18, and particularly along the length of the shaft or sub-assembly including the heating element 214. For example, the one or more electrical conduits 216a, 216b can extend along the length of the central shaft or central shaft sub-assembly 24. The one or more electrical conduits 216a, 216b can extend outside the central shaft or central shaft sub-assembly 24 (as shown in ​ , 35 and 36) or inside the central shaft or central shaft sub-assembly 24 (e.g., within the lumen of the central shaft or central shaft sub-assembly 24), or can be fully or partially embedded in the wall of the central shaft or central shaft sub-assembly 24 (as shown in ​ ). The one or more electrical conduits 216a, 216b can extend along any other sub-assembly or shaft of the elongate shaft or shaft assembly 18 in a similar manner.

[0221] In an example, distal portions 222a, 222b of the one or more electrical conduits 216a, 216b may pass through a portion of the distal end of the central axis or central axis subassembly 24 to connect to the heating element 214 (as shown in the exploded view of ​ ). In an example, the one or more electrical conduits 216a, 216b may be passed from the exterior of the central axis or central axis subassembly 24 to the interior of the central axis or central axis subassembly 24 (e.g., the distal pusher 138).

[0222] The one or more electrical conduits 216a, 216b may be configured to be insulated or otherwise not transfer heat to the surrounding system or environment. For example, the one or more electrical conduits 216a, 216b may be insulated or may be covered with an insulating material (e.g., a coating) to reduce the likelihood of heat transfer to the surrounding system or environment. In an example, the one or more electrical conduits 216a, 216b may be made of a material that remains at substantially the same temperature when electrical energy (e.g., current) passes through the one or more electrical conduits 216a, 216b. For example, the junctions 226a, 226b may include a transition of material from the heating material of the heating element 214 to the non-heating material of the one or more electrical conduits 216a, 216b. Other configurations may be used in an example.

[0223] Proximal portions 224a, 224b of the one or more electrical conduits 216a, 216b may be configured to be coupled to a power source 228 (labeled in ​ ) to provide electrical energy to the heating element 214 through the one or more electrical conduits 216a, 216b. The power source 228 may be configured to supply power to the heating element 214. The power source 228 may have any form as needed (e.g., a battery, a power connector, a capacitor, etc.). The power source 228 may be located on the handle 16 or may have another location as needed (e.g., the power connector may include a mains connector connected to a power outlet, which may be a wall outlet or other form of outlet). An actuator 230 (labeled in ​ ) may be used to selectively control the transmission of power through the one or more electrical conduits 216a, 216b.

[0224] Reference ​, the heating element 214 of the disintegration component 212 can be configured to be connected to a portion 213 of the one or more coupling tethers 215. For example, the heating element 214 can be configured as a loop to allow the portion 213 to include loop portions 213a, 213b, 213c for extending above the heating element 214. The loop portions 213a, 213b, 213c can include the vertices of the coupling tether 215. The loop portions 213a, 213b, 213c can include end portions of the one or more coupling tethers 215, which can loop above the filaments including the loop. In an example, the loop portions 213a, 213b, 213c can correspond to ​ the loop portions 188a, 188b, 188c shown therein. However, ​ the loop portions 213a, 213b, 213c shown therein (which can be referred to as the second portion of the coupling tether 215) can be guided proximally toward the heating element 214 and can loop above the heating element 214. The intermediate portion of the coupling tether 215 (which can be referred to as the first portion of the coupling tether 215) can form a loop portion 232 (marked in ​ ), and the loop portion can be coupled to the implant to hold the implant to the elongate shaft 18. The loop portion 232 can, for example, protrude through a corresponding opening (e.g., an eyelet) in a portion of the implant 176 to be coupled to the implant, as discussed with respect to ​ .

[0225] The coupling tether 215 can include an end portion 234, which can be coupled to a tether manifold or other coupling point of the tether 215. For example, the tether manifold 236 (marked in ​ ) can be configured similar to the tether manifold 144 shown in ​ , or can have another configuration in an example. The end portion 234 can loop around an arm of the tether manifold 236, or can have another configuration in an example. The tether manifold 236 can be coupled to a flexible retention tether 238, which can be configured similar to the flexible retention tether 146 shown in ​ , or can have another configuration as needed. Other configurations of the tether assembly or sub-assembly can be used as needed, including other configurations as disclosed herein.

[0226] In an example, the use of a tether manifold and / or a flexible retention tether can be excluded. For example, the first portion of the tether 215 can include an end portion coupled to the implant. The second portion of the tether 215 can include an opposite end portion coupled to the heating element 214.

[0227] In an example, the coupling tether may have a first end coupled to a heating element on a central axis or central axis sub - assembly 24, and an intermediate portion forming a loop for coupling to an implant. A second end of the coupling tether may be coupled back to the central axis or central axis sub - assembly 24. The heating element may be heated to release the first end of the coupling tether. The second end of the coupling tether may be held by the central axis or central axis sub - assembly 24. Thus, the use of a tether manifold and / or a flexible retention tether may be eliminated.

[0228] In an example, the coupling tether may have a first end coupled to a heating element and an intermediate portion forming a loop for coupling to an implant. The heating element may be positioned on a tether manifold and / or a flexible retention tether. A second end of the coupling tether may be coupled back to the tether manifold and / or the flexible retention tether. The heating element may be heated to release the first end of the coupling tether. The second end of the coupling tether may be held by the tether manifold and / or the flexible retention tether.

[0229] Other configurations and positions of the couplings may be utilized in examples.

[0230] In a deployment procedure, the implant may be held by an elongate catheter or delivery device 12 in a manner similar to that disclosed herein. For example, an outer sheath shaft or sub - assembly 20 may extend over the implant and hold the implant in a compressed configuration. The outer sheath shaft or sub - assembly 20 (e.g., the capsule sub - assembly 36) may be retracted proximally to allow the implant to expand radially outwardly in a manner similar to that disclosed herein. For example, ​ The retraction of the capsule sub - assembly 36 is shown to allow the implant to expand radially outwardly. The proximal end of the implant is shown to be held by a distal pusher 138.

[0231] The tether assembly or sub - assembly may be advanced distally to allow the implant to be released from the distal pusher 138 when needed. The tether assembly or sub - assembly may be advanced to allow the coupling tether 215 to expand radially outwardly, thereby allowing the implant to expand more fully. For example, ​ The proximal end of the implant released from the distal pusher 138 is shown. The end portions 234 of the coupling tether 215 have been advanced distally relative to the central axis or central axis sub - assembly 24 with the flexible retention tether 238 to allow the coupling tether 215 to expand radially outwardly.

[0232] At a desired time, the disintegration assembly 212 may be activated to release the implant from the elongate shaft or shaft assembly 18. Referring to ​ , for example, a cross - sectional view of the disintegration assembly 212 is shown prior to the disintegration of the connection to the coupling tether 215. The loop portion 232 of the coupling tether 215 may extend outwardly from the distal pusher 138, but the end portions 213a, 213b remain connected to the heating element 214. The opposing end portions 234 may remain connected to the tether manifold 236.

[0233] The actuator 230 can be activated at a desired release time. For example, ​ A configuration is shown in which the actuator 230 has been activated. Electrical energy can pass through the electrical conduits 216a, 216b, and the heating element 214 can be activated. The heating element 214 can be heated, and the heat can disintegrate the loop portions 213a, 213b, thereby disintegrating the connection to the loop portions 213a, 213b. For example, the heating element 214 can melt or otherwise disintegrate the loop portions 213a, 213b. The loop portions 213a, 213b can be severed. The loop portions 213a, 213b can thus include free ends 240a, 240b that are not coupled to the heating element 214 (marked in ​ ). The end portion 234 can remain connected to the tether manifold 236.

[0234] For example, ​ A side view of the resulting configuration of the coupling tether 215 is shown. The free ends 240a, 240b of the coupling tether 215 (with the additional free ends of the respective tether 215 shown in ​ ) can be capable of being pulled through the eyelets of the implant to completely release the implant from the elongate shaft 18. The end portion 234 (marked in ​ ) can remain connected to the tether manifold 236 and can be withdrawn with the tether manifold 236 when the elongate shaft 18 is retracted from the implantation site. The end portion 234 can be pulled proximally with the tether manifold 236 to cause the coupling tether 215 to be pulled through the eyelets of the implant.

[0235] In an example, other forms of disintegration components can be utilized. For example, a direct connection of the disintegration component to the frame of the implant can be utilized, where the direct connection disintegrates at a desired time. A material that can disintegrate at a desired time can be used to connect the frame of the implant to the disintegration component. Electrical energy or other forms of energy (e.g., heat) can be used to cause the connection to disintegrate. In an example, chemical actuation can be used to cause the connection to disintegrate. Other forms of disintegration components can be used in the example.

[0236] Other forms of disintegration of the coupling tether can be utilized. For example, ​ and 39 An example is shown in which the disintegration component 242 includes an intermediate body 244 configured to disintegrate. The disintegration of the intermediate body 244 can disintegrate the connection to the coupling tether 246.

[0237] For example, the coupling tether 246 can be configured similarly to the coupling tether 215 and have an end portion or loop portion 248 that can be connected to the intermediate body 244. The loop portion 248 can extend over the intermediate body 244 or otherwise be coupled to the intermediate body 244. The intermediate body 244 can have an annular shape or can have any other configuration as needed (e.g., a strip of material, a coil, one or more pins, one or more hooks, one or more terminals, etc.). The opposite end portion 250 of the coupling tether 246 can be configured similarly to ​ the end portion 234 shown therein (e.g., coupled to the tether manifold), or can have another configuration as needed.

[0238] The heating element 252 can be used to disintegrate the intermediate body 244. For example, the heating element 252 can be in contact with the intermediate body 244 and can be configured to transfer heat to the intermediate body 244, which can cause the intermediate body 244 to melt or otherwise disintegrate. For example, the intermediate body 244 can be made of a disintegratable material, such as a meltable filament, a biocompatible material, or other disintegratable materials.

[0239] For example, ​ is shown the disintegrated intermediate body 244. The loop portion 248 is released from the intermediate body 244, which allows for release from the implant.

[0240] Other configurations of the cutting and / or disintegration assembly can be utilized. Any means for cutting, melting, disintegrating the coupling tether or separating the coupling tether from the implant to facilitate implantation into the body is envisioned and is thus within the scope of the present disclosure.

[0241] ​ and 41 shows another example of the disintegration assembly 258, where the first electrical terminal 260a can be displaced relative to the second electrical terminal 260b and is configured to contact the second electrical terminal 260b to complete the circuit for electrical energy to pass through the heating element 262.

[0242] Referring ​ , the heating element 262 can include a portion of the tether manifold 264 that is coupled to an end portion or loop portion 266 of the coupling tether 268. The end portion or loop portion 266 can extend over or loop around the heating element 262. The heating element 262 can have a straight or linear shape and can include an arm of the tether manifold 264.

[0243] The coupling tether 268 can have an end portion 270 that is coupled to a coupling point as needed, such as a point on the inner surface of the distal pusher 138 or another point.

[0244] The first electrical terminal 260a can be coupled to a first electrical conduit 272a that can extend to a power source 228. The first electrical terminal 260a can be configured to move as needed with the movement of the tether manifold 264. For example, the first electrical terminal 260a can be retracted or advanced with the tether manifold 264 as needed.

[0245] The second electrical terminal 260b can be positioned on the axis of the elongate conduit, such as on the inner surface of the lumen of the central axis or central axis subassembly 24. The second electrical terminal 260b can be positioned on the inner surface of the distal pusher 138 or at another location as needed. The second electrical terminal 260b can be in a fixed position or can move relative to one or more axes of the elongate shaft or shaft assembly 18. As ​ shown, the second electrical terminal 260b can be in a fixed position relative to the central axis or central axis subassembly 24. The first electrical terminal 260a can move relative to the central axis or central axis subassembly 24.

[0246] The second electrical terminal 260b can be coupled to a second electrical conduit 272b that can extend to the power source 228. In an example, the second electrical conduit 272b can be embedded in the wall of the central axis or central axis subassembly 24. In an example, the second electrical conduit 272b can include the wall of the central axis or central axis subassembly 24. For example, the wall can be conductive to allow for the transmission of electrical energy. Other configurations can be used as needed.

[0247] The first electrical terminal 260a can be unconnected to the second electrical terminal 260b when the disintegration assembly 258 is not activated. ​ illustrates this configuration.

[0248] At a desired time, the first electrical terminal 260a and the second electrical terminal 260b can move relative to each other to contact the terminals 260a, 260b. This movement can be produced in a variety of ways. In an example, the movement can occur based on the distal movement of the tether manifold 264 to advance the coupling tether 268 distally. This movement can include the deployment movement of the tether manifold 264. In an example, the movement can be produced based on other sliding movements of one or more axes within the axis of the elongate conduit relative to each other.

[0249] In an example where the movement occurs based on the distal movement of the tether manifold 264, the movement can be used to ensure that activation of the disintegration assembly cannot occur until a desired alignment of the shafts relative to each other is achieved. In an example as ​ and 41 shown, the disintegration assembly 258 can not be activated until the tether manifold 264 is advanced distally relative to the central axis or central axis subassembly 24. This feature can be used to ensure that the implant does not release prematurely, or until the tether manifold 264 is advanced to a deployed position.

[0250] For example,​ The tether manifold 264 that has been advanced distally is shown. The first electrical terminal 260a and the second electrical terminal 260b are in contact with each other to complete the circuit that enables electrical energy to pass through the heating element 262. The heating element 262 can disrupt the connection to the coupling tether 268 and produce ​ the free ends 274a, 274b as shown in. By doing so, the coupling tether 268 can be released from the implant.

[0251] In an example, other configurations of the disruption assembly can be utilized. The features of the disruption assembly can be used alone or in combination with any of the other examples disclosed herein.

[0252] Various forms of coupling tethers can be utilized, and the scope of the present disclosure should not be limited to any particular coupling tether configuration. For example, ​ and 43 a configuration is shown in which a flexible retaining member or tether 280 is woven or braided. The flexible retaining tether 280 can include a plurality of sutures woven or braided into a larger suture. The tether manifold 282 can include the separation of the plurality of coupling tethers 284 from the flexible retaining tether 280. The plurality of coupling tethers 284 can be woven or braided out of the flexible retaining tether 280 and can include a woven or braided sub - portion of the flexible retaining tether 280. For example, the flexible retaining tether 280 can include twenty - four strands, which can be divided into three groups of eight strands each (for three coupling tethers 284). Various divisions can be utilized as needed (e.g., more or fewer coupling tethers, or more or fewer strands per coupling tether). The braid can include a cylindrical braid or a flat braid, or can have another configuration in an example.

[0253] ​ the individual coupling tethers 284 shown in can loop back towards the flexible retaining tether 280 to form a loop portion 286 of the coupling tether 284 (marked in ​ ). For example, the free end 288 of the coupling tether 284 can loop back to be buried in the tether manifold 282 or the flexible retaining tether 280. For example, ​This configuration is shown in a partial cross - section. For example, the free end 288 of the connecting tether 284 is inserted into the central channel 290 of the tether manifold 282 or the flexible retaining tether 280 and buried within the central channel. The free end 288 can be buried within the main portion 281 of the flexible retaining tether 280 proximal to the tether manifold 282. Friction with the wall of the central channel 290 can hold the free end 288 of the connecting tether 284 within the central channel 290. In an example, other configurations can be utilized to form the loop portion 286. In an example, the cross - sectional area of the main portion 281 of the flexible retaining tether 280 can be the same as the combined cross - sectional area of the plurality of connecting tethers 284. In an example, the length of each of the plurality of connecting tethers 284 from the tether manifold 282 can be greater than 0.5 inches (or greater than 1 inch), or other lengths can be used in an example.

[0254] Reference ​ , the free end 288 can pass through the wall of the tether manifold 282 to lock to the tether manifold 282 or the flexible retaining tether 280. A portion of the connecting tether 284 can be positioned within the central channel 290 and held within the central channel 290. In an example, the locking can occur due to gluing or melting (e.g., reflow) of the connecting tether 284 or other forms of bonding.

[0255] ​ and 46 Another example is shown where one or more of the connecting tethers can include a woven or braided loop 292. For example, ​ a woven or braided cylinder 294 is shown, which can be formed by weaving or braiding. The cylinder 294 can include a central opening 296 of a central lumen formed during the weaving or braiding process. The central axis can be within and extend along the central lumen. The cylinder 294 can be cut in a direction transverse to the central axis of the cylinder 294 to form a loop 292, as ​ shown. One or more horizontal cuts can be made, which can be perpendicular to the central axis of the cylinder 294. The loop 292 is indicated by a dashed line in ​ and can form part of the cylinder 294.

[0256] ​ The loop 292 is shown cut from the remainder of the cylinder 294 and shown isolated from the remainder of the cylinder 294. The woven or braided loop 292 can surround a central opening 298.

[0257] The loop 292 can form one or more connecting tethers. In an example, a portion of the loop 292 can be coupled to the tether manifold or the flexible retaining member or tether to form a loop suitable for coupling to an implant. In an example, the loop 292 can form a plurality of connecting tethers. For example, ​It is shown that a portion 300 of the loop 292 has been coupled to the tether manifold 302. At least two loop portions 304a, 304b may extend distally from the tether manifold 302. Each loop portion 304a, 304b may include a coupling tether for coupling to a portion of an implant. In an example, a greater number of loops 292 may be used to produce a desired number of coupling tethers. In an example, two portions of the loop 292 may be coupled to the tether manifold 302 to produce three resulting loop portions and coupling tethers. In an example, multiple loops 292 may be coupled to the tether manifold 302 to produce a desired number of coupling tethers (e.g., two loops 292 may be coupled to provide four coupling tethers or six coupling tethers; three loops 292 may be coupled to provide six coupling tethers or nine coupling tethers). More or fewer loops 292 may be used as needed.

[0258] ​ A partial cross-sectional view showing the coupling of the loop 292 to the tether manifold 302 is shown. At least a portion of the tether manifold 302 may overlap with the woven or braided loop 292 to couple the woven or braided loop to the tether manifold 302. For example, a length 306 of the tether manifold 302 may extend over the loop 292, with a free end 308 buried in a channel 310 of the tether manifold 302. This configuration may hold the loop 292 to the tether manifold 302. In an example, the free end 308 may be locked to the tether manifold 302 in a manner similar to that shown in ​ . In an example, the free end 308 may be glued or melted (e.g., reflowed) into the tether manifold 302 to hold the loop 292 to the tether manifold 302.

[0259] ​ It is shown that the tether manifold 312 includes a configuration of warp yarns 314 woven with weft yarns 316, and multiple coupling tethers 318 each include a continuation of the warp yarns 314 of the tether manifold 312 that lack any weaving with the weft yarns 316.

[0260] For example, referring to ​ , a fabric 320 including a section 322 may be formed, the section including warp yarns 314 and weft yarns 316. The length of the section 322 may be set as needed during the weaving process. At a desired point during the weaving process, the weaving may stop using the weft yarns 316. A section 324 may be formed, the section including warp yarns 314 and lacking any weaving with the weft yarns 316 (since the weft yarns 316 have been interrupted). The length of the section 324 may be set as needed. In an example, the length of the section 324 may be set based on the desired length of the coupling tether.

[0261] During the weaving process at desired points, the use of the weft yarn strand 316 can be resumed. The resulting section 326 can have a section 324 formed between sections 322 and 326. Section 326 can include the weft yarn strand 316. The length of section 326 can be set as needed. ​ Exemplary lengths of sections 322, 324, and 326 that can be produced are shown. Section 322 can extend, for example, at least 50 inches, 60 inches, 70 inches, or 80 inches in length. Section 326 can extend, for example, at least 50 inches, 60 inches, 70 inches, or 80 inches in length. For example, in an instance, section 324 can extend at least 1 inch, 2 inches, or 3 inches in length. Various other lengths can be used as needed. The lengths can be determined during the weaving process.

[0262] For example, the length 328 and width 331 of the fabric 320 can be cut to produce the desired dimensions of the tether assembly. The width 331 can be set as needed. For example, the width 331 can be cut according to the desired number of coupling tethers that can be used with the tether assembly. For example, ​ The resulting cut fabric 320' is shown, which includes a width having nine warp yarn strands 314 that will be used to produce nine coupling tethers. More or fewer warp yarn strands can be retained in the cut fabric 320'.

[0263] Section 326 can be folded back onto section 322, thus forming an overlapping section 329 (marked in ​ ). Gluing or melting (e.g., reflow) can be used to bond sections 326 and 322 to each other. Thus, the folding of section 326 can form loops of the warp yarn strands 314 that are longitudinally positioned between sections 322 and 326 in ​ . The loops of the warp yarn strands 314 can include looped coupling tethers 330. The coupling tethers 330 can be used to couple to a portion of an implant as needed. The length of the coupling tethers 330 can be half the length of section 324 as shown in the instance in ​ .

[0264] In an instance, the strands can include braided sutures. The strands including the warp yarn strands can be load-bearing braided sutures, and / or the strands including the weft yarn strands can be load-bearing braided sutures. In an instance, any tether as disclosed herein can include braided sutures or other forms of material.

[0265] ​ The fabric of the warp and weft yarn strands shown in ​An exemplary warp and weft weaving pattern in a stacked configuration is shown. A vertical stack 332 and a horizontal stack 334 may be provided. The weft yarn strands 336 may follow a pattern as ​ shown (where the path of the weft yarn strands of the first shuttle or shuttle 1 is indicated by short dashes and short dotted lines, and the path of the weft yarn strands of the second shuttle or shuttle 2 is indicated by long dashes and long dotted lines). The stacked configuration may form a tether manifold and / or a flexible retaining member or tether as needed. The stacked configuration may be layered on itself to form looped connecting tethers in a manner similar to that disclosed with respect to ​ The layered stacked configuration may result in eighteen warp yarn strands at the tether manifold. The stacked configuration may be glued or melted (e.g., reflowed) to bond the sections together. In an example, more or fewer than nine warp yarn strands may be utilized as needed.

[0266] In an example, other configurations may be used. For example, ​ a configuration is shown in which multiple strands 340a, 340b, 340c, 340d form respective loops 342a, 342b, 342c, 342d. Each strand 340a, 340b, 340c, 340d includes portions 344, 346 coupled to respective bobbins 348, 350. The loops 342a, 342b, 342c, 342d may each be coupled to a loop base 352 having respective numbers of loop retainers 354a, 354b, ३५4c, 354d. The loop retainers 354a, 354b, 354c, 354d may include hooks or may have other configurations as needed. The loop base 352 and the loop retainers 354a, 354b, 354c, 354d may hold the loops 342a, 342b, 342c, 342d during a weaving or braiding process.

[0267] The loops 342a, 342b, 342c, 342d may be looped over a respective one of the loop retainers 354a, 354b, 354c, 354d. The bobbins 348, 350 for the respective strands 340a, 340b, 340c, 340d may be coupled to actuators 355a, 355b (labeled in ​ ), which move the bobbins 348, 350 to form a fabric or braid of the strands 340a, 340b, 340c, 340d. For example, ​Shows the resulting fabric or braid 356 formed by the movement of bobbins 348, 350. Yarns 340a, 340b, 340c, 340d are woven or braided together with loops 342a, 342b, 342c, 342d remaining at the distal end of the fabric or braid. During the weaving or braiding process, loop retainers 354a, 354b, 354c, 354d hold loops 342a, 342b, 342c, 342d.

[0268] ​ The formation of fabric or braid 356 of yarns 340a, 340b, 340c, 340d represented in can continue to a desired length. At a desired time, the fabric or braid 356 process can be interrupted and the proximal end of the fabric or braid 356 can be cut. The resulting configuration is shown in ​ Tether manifold 360 may include a combination of respective loops 342a, 342b, 342c, 342d, and flexible retaining tether 362 may include fabric or braid 356 of yarns 340a, 340b, 340c, 340d. The coupling tether may include loops 342a, 342b, 342c, 342d held during the weaving or braiding process. Tether manifold 360 may include fabric or braid (including loops 342a, 342b, 342c, 342d) of yarns 340a, 340b, 340c, 340d that couple the tethers. The proximal portion 358 of fabric or braid 356 may include the proximal free ends of yarns 340a, 340b, 340c, 340d that form respective loops 342a, 342b, 342c, 342d.

[0269] It will be appreciated that ​ any of the features of can be used alone or in combination with each other, or in combination with any other examples disclosed herein. In various examples, nine coupling tethers are shown and described. However, any greater or lesser number of loops or coupling tethers may be utilized (e.g., at least three, at least six, at least nine, at least twelve, etc.).

[0270] ​ An example of release assembly 600 or subassembly is shown. Unless otherwise stated, release assembly 600 or subassembly may include features of other release assemblies or subassemblies (e.g., release assembly or subassembly 28). Release assembly 600 includes release tether 602 having a proximal end coupled to release tether manifold 604. Representative release tethers 602a, 602b are marked in the cross-sectional view of ​ Retractable tether 606 (or other elongated structure) extends proximally from release tether manifold 604.

[0271] The release tether manifold 604 may include a fitting for the release tether 602. For example, as shown in the cross-sectional view of ​ , the release tether 602a may be spliced through the release tether 602b to form two lengths 608, 610 each extending from the fitting 612. Thus, two release tether bodies may be used to form three release tethers 602. In an example, more or fewer release tethers may be used.

[0272] The fitting 612 may be covered with a sheath 614, which may secure the fitting connection between the release tethers 602a, 602b. The sheath 614 may include a tube or a shrink tube or a backflow material for securing the fitting connection. The release tether 602 may include a rope, a cable, a wire, or other forms of tether, and may be flexible. The sheath 614 may include a polymeric material (e.g., plastic), which may secure the connection between the release tethers 602a, 602b. In an example, the fitting connection may include a brummel splice, but other forms of fittings may be used in an example. Knot connections (e.g., a single sheet bend, a clove hitch, an alpine butterfly knot, or other forms of knots) may be used in an example.

[0273] The release tether 602, the release tether manifold 604, and the retractable tether 606 have sufficient flexibility and axial strength to withstand the proximal tension for retracting and removing the release tether 602, thereby allowing the coupling tether to be detached from the implant. The release assembly 600 is preferably flexible to conform to the curved or deflected portion of the elongate shaft or shaft assembly disclosed herein. In an example, other forms of release assemblies or sub-assemblies may be used.

[0274] ​ Any one of the features of or 56B may be used alone or in combination with each other, or in combination with any other examples disclosed herein.

[0275] ​ Variations in the configuration of the release assembly 600 or sub-assembly are shown. In ​ 's configuration, multiple release tethers are utilized (with three release tethers 603a, 603b, 603c as shown in ​ ). The release tethers 603a, 603c have respective proximal ends 605a, 605c, which are positioned within the sheath 614 at the release tether manifold 607. The release tethers branch out from the release tether manifold 607. The proximal ends 605a, 605c are joined to the release tether 603b at the release tether manifold 607. The sheath 614 couples the ends 605a, 605c to the release tether 603b, where the ends 605a, 605c have offset lengths. Thus, a tapered fitting may be created at the release tether manifold 607.

[0276] ​Any of the features may be used alone or in combination with each other, or in combination with any other examples disclosed herein.

[0277] ​ and 59 FIG. shows another example of the tether assembly 630 or a sub - assembly. Unless otherwise stated, the tether assembly 630 or the sub - assembly may include features of other tether assemblies or sub - assemblies. The tether assembly 630 includes a coupling tether 632 having a proximal end coupled to a tether manifold 634. A flexible retaining tether 636 extends proximally from the tether manifold 634.

[0278] The flexible retaining tether 636 may include a wire or tube that extends distally into the tether manifold 634. The flexible retaining tether 636 may include a receiving portion or lumen 638 (labeled in ​ for receiving the tether manifold 634. For example, the tether manifold 634 may include arm lengths 640a, 640b (labeled in ​ that may extend into the receiving portion or lumen 638. The arm lengths 640a, 640b may be crimped or otherwise coupled to the receiving portion or lumen 638 to secure the tether manifold 634 to the flexible retaining tether 636. In an example, other forms of flexible retaining tethers and couplings to the tether manifold may be used.

[0279] The tether manifold 634 may include an elongate arm 640 that may include a loop portion 642 at its distal end. The loop portion 642 is shaped to facilitate attachment to the coupling tether 632. The arm 640 may include a wire or cable that may be shaped to form the loop portion 642. The tether manifold 634 and the flexible retaining tether 636 may be configured to have axial stiffness or column strength to allow distal driving force or compressive force to be transmitted along the length of the tether manifold 634 and the flexible retaining tether 636 (e.g., to distally advance or expand a coupled implant). The tether manifold 634 and the flexible retaining tether 636 may have lateral flexibility to allow conformance to the curved or deflected portions of the elongate shaft or shaft assembly disclosed herein.

[0280] The proximal portion 641 of the coupling tether 632 is coupled to the tether manifold 634. The proximal portion 641 of the coupling tether 632 may be looped around the loop portion 642 of the arm 640 in a manner similar to that disclosed with respect to ​ For example, a single tether body may alternatively be looped around the arm 640 to form multiple coupling tethers 632. In an example, other forms of coupling may be utilized.

[0281] In an example, a sheath 644 can be provided that extends over the proximal portion 641 of the attachment tether 632. The sheath 644 can be positioned distal to the loop portion 642 of the arm 640, or in an example, can extend proximally to cover the loop portion 642 of the arm 640. The sheath 644 can be used to secure the connection of the attachment tether 632 to the tether manifold 634 and can enhance the stiffness of the connection to improve the transmission of a distal driving force or compressive force to be transmitted to the attachment tether 632. The sheath 644 can include a tube or shrink tube or return material at the proximal portion 641 of the attachment tether 632.

[0282] In an example, the attachment tether 632 can have a length from the proximal portion 641 of the attachment tether 632 to the loop portion, attachment portion, or distal portion 646 of the attachment tether 632 that extends along a curved or deflected portion of the elongate axis or axis assembly disclosed herein. Thus, in an example, the attachment tether 632 can extend through a curved or deflected portion (e.g., a portion corresponding to a primary flexure or secondary flexure of a guide rail axis) where the tether manifold 634 and the flexible retention tether 636 are held adjacent to this portion. Other configurations can be used in an example.

[0283] ​ Any one of the features of 59 or can be used alone or in combination with each other, or in combination with any other example disclosed herein.

[0284] In an example, variations in the configuration of the tether assembly or sub-assembly can be provided. For example, ​ A perspective view of the tether manifold 650 of the tether assembly 652 or sub-assembly is shown (shown in a partial cross-sectional view in ​ ).

[0285] The tether manifold 650 can include one or more connectors 654 for coupling to the attachment tether 656 (labeled in ​ ). The connector 654 can include a notch or tab in a surface of the material to which the attachment tether 656 can be looped. The notch or tab can be in a surface (e.g., an outer surface) of the flexible retention tether 658. The connectors 654 can be circumferentially equidistantly spaced from each other (where three connectors 654 are equidistantly spaced from each other at, for example, 120 degrees). Other spacings or numbers of connectors 654 can be utilized as needed (e.g., at least two, at least three, at least four, etc.).

[0286] The attachment tether 656 can be looped around the connector 654 as a single loop. Refer to ​, for example, the connecting tether 656a can include two loops, where the proximal loop 660a loops around the connector 654 and has a distal loop 662a at the distal portion of the connecting tether 656a. Other connecting tethers (e.g., connecting tethers 656b, 656c) can loop similarly. Other forms of connection can be utilized (e.g., an alternating loop configuration as disclosed with respect to Figure 14 or other forms of connection). More or fewer connecting tethers can be used as needed. In the case of three connectors 654 and three respective connecting tethers 656, a total of nine connecting tethers 656a - i can be used (as labeled in Figure 61 ). More or fewer numbers can be used as needed.

[0287] The connecting tether 656 can extend along the outer surface 663 of the tether manifold 650, as represented in the cross - sectional view of Figure 60B .

[0288] In an example, a friction feature 664 can be provided at the distal portion of the tether manifold 650. The friction feature 664 can include a notch, ridge, or recess in the outer surface 663 of the tether manifold 650 to enhance the friction with the connecting tether 656 extending along the outer surface 663. In an example, the distal portion of the tether manifold 650 can include a flexible material but can have sufficient column strength for a distal compressive force.

[0289] In an example, a sheath 666 can extend over the proximal portion 668 of the connecting tether 656 that covers the tether manifold 650. The sheath 666 can be used to fasten the connection of the connecting tether 656 to the tether manifold 650 and can enhance the stiffness of the connection to improve the transmission of the distal driving force or compressive force to be transmitted to the connecting tether 656. The sheath 666 can include a tube, shrink tube, or reflow material at the proximal portion 668 of the connecting tether 656. For example, the sheath 666 is shown in Figure 61 as having a profile that forms the shape of the connecting tether 656 through a reflow or shrink process. In an example, the sheath 666 can extend proximally to cover the connector 654.

[0290] Figure 61 is shown along Figure 60BCross-sectional view of the tether manifold 650 along line I-I therein. The portion of the tether manifold 650 covered by the coupling tether 656 may include a tube having an internal lumen 670. The flexible retention tether 658 may also include a tube, and the internal lumen 670 may extend proximally along the length of the flexible retention tether 658. The internal lumen 670 may be adapted for the nasal cone axis to extend therethrough within components of the delivery system. The internal lumen 670 may be adapted for a release assembly or sub-assembly as disclosed herein to extend therethrough. In an instance where the release assembly extends through the internal lumen 670, the release tether may be retracted proximally through the internal lumen 670. The coupling tether 656 may be positioned symmetrically about the tether manifold 650. Other configurations may be used in instances. For example, the nasal cone axis may be positioned within the internal lumen 670, and in an instance, the release assembly may be positioned external to the internal lumen 670.

[0291] Figures 60A to 61 Any of the features may be used alone or in combination with each other, or in combination with any other instance disclosed herein.

[0292] Variations in the configuration of the delivery system as disclosed herein may be provided. Figures 62 to 66 A delivery system 680 or delivery catheter is shown, which includes variations in the configuration of the delivery system 10 discussed with respect to Figures 1 to 31 Unless otherwise specified, the features of the delivery system 10 are used in conjunction with the features of the delivery system 680 shown in Figures 62 to 66 With respect to the other features of the delivery system 10 discussed with respect to Figures 1 to 31 such as the configuration of any shaft or sub-assembly, may be used in conjunction with the delivery system 680. Features of other instances disclosed herein (e.g., Figures 32 - 61 instances) may be used in conjunction with the delivery system 680 as needed.

[0293] The delivery system 680 may be used to deploy a prosthesis, such as a prosthetic heart valve, to a location within a subject's body. The delivery system 680 includes a plurality of components, devices, and / or sub-assemblies. As shown in Figure 62 the delivery system 680 may include an elongate catheter, a delivery device or delivery catheter 681, and a stabilizer assembly 1120 ( Figure 120shown in the perspective view), and other components as needed. The delivery catheter 681 may include an elongate shaft or shaft assembly 683 and a housing in the form of a handle 682. The housing may be at the proximal portion of the elongate shaft 683 or shaft assembly. The elongate shaft 683 may include one or more shafts. According to the examples herein, multiple shafts may be provided, but in an example, a single shaft may be utilized. Unless otherwise noted, the elongate shaft 683 or shaft assembly may be configured similarly to the elongate shaft or shaft assembly 18. The elongate shaft 683 may be adapted to deflect about a curved portion 685 of the elongate shaft 683. Other shafts of the elongate shaft 683 may slide along the curved portion 685 to change the depth of the distal portion of the elongate shaft 683.

[0294] Examples of the control mechanism or handle 682 are shown in Figures 63 to 66 which. The control mechanism or handle 682 includes variations of the handle 16 previously discussed with respect to Figures 1 to 31 . The control mechanism or handle 682 may be adapted to control the deflection of the elongate shaft 683 or shaft assembly and other features (e.g., control the depth of the elongate shaft 683, the height of the elongate shaft 683, and / or the expansion or release of the implant). The handle 682 includes a housing that includes a first housing 684 and a second housing 686. The second housing 686 may be coupled to a guide rail shaft or sub-assembly. The first housing 684 may be coupled to one or more shafts that are adapted to slide relative to the guide rail shaft or sub-assembly to change the depth of such shafts relative to the guide rail shaft or sub-assembly. The first housing 684 may include a distal portion 688 and a proximal portion 690, where the second housing 686 is intermediate the distal portion 688 and the proximal portion 690 and extends around the first housing 684 at an intermediate portion of the first housing 684 (as shown in the cross-sectional view of Figure 66 ).

[0295] The handle 682 includes a balloon actuator or knob 692 (which may include features of the balloon actuator or knob 34), a corresponding actuator assembly, a deflection actuator, control knobs or flexure knobs 694A, 694B (which may include features of the corresponding flexure knobs 124A, 124B), a knob assembly 696 or depth actuator or depth knob, a coupling tether actuator or knob 698, and a release actuator or knob 700. Unless otherwise noted, the actuators may operate in a manner similar to other corresponding actuators disclosed herein.

[0296] The configuration of one or more shafts or sub-assemblies may be different from the configuration disclosed with respect to the delivery system 10. Figures 67 to 70 For example, variations of the guide rail shaft or sub-assembly 22 that may be used in the examples herein are shown.

[0297] Refer to Figure 67, an elongated shaft 710 or rail shaft or subassembly is shown. The elongated shaft 710 may include features of the rail shaft or subassembly 22 and may be adapted to deflect in one or more planes. Other shafts of the delivery system 680 as disclosed herein may be adapted to slide relative to the elongated shaft 710 to vary the depth of those shafts along the elongated shaft 710.

[0298] The elongated shaft 710 or guide shaft or guide subassembly includes an outer sheath 712. The outer sheath 712 has a distal portion 714, a proximal portion 716 (at Figure 65 and 66 ), and the length between the distal portion 714 and the proximal portion 716.

[0299] Unless otherwise noted, the outer sheath 712 includes a proximal shaft 718 or a guide proximal shaft, which can be configured similarly to the proximal shaft 112. The distal end of the proximal shaft 718 can be adjacent to a hypotube 720 of the outer sheath 712. Unless otherwise noted, the hypotube 720 can include features of the hypotube 114. The hypotube 720 can include a curved portion configured to form a curve for other shafts or sheaths of the delivery system to follow. The other shafts or sheaths slide relative to the curved portion to change the depth of the shafts or sheaths relative to the hypotube 720.

[0300] The distal portion 714 of the outer sheath 712 can include one or more slotted portions or sections 722, 724, 726. Each slotted portion or section 722, 724, 726 can include a respective distal portion 722a, 724a, 726a and a proximal portion 722b, 724b, 726b. The pattern of slots or cutouts in each section 722, 724, 726 can define the direction or plane or deflection of the respective section 722, 724, 726.

[0301] Unless otherwise noted, the distal-most segment 722 may include features of the distal slotted hypotube segment 126D. The distal-most segment 722 may be adapted to bend or deflect in a plane to produce a primary deflection (e.g., a medial-lateral trajectory) of the elongated shaft 710. In tricuspid valve embodiments, a modification may be provided in which the distal-most segment 722 provides an anterior-posterior trajectory.

[0302] Unless otherwise noted, the intermediate segment 724 may include features of the proximal slotted hypotube segment 126P. The intermediate segment 724 may be adapted to bend or deflect in a plane transverse or perpendicular to the plane of the distal-most segment 722 to produce a secondary deflection (e.g., an anterior-posterior trajectory) of the elongated shaft 710. When adapted for deployment of a prosthetic heart valve within a native tricuspid valve, a modification may be provided in which the intermediate segment 724 provides a septal-lateral trajectory.

[0303] The proximal section 726 can be adapted to bend or deflect in the plane of the distal-most section 722, but in an opposite direction within the plane. Thus, the proximal section 726 can be adapted to provide the height of the elongated shaft 710 or delivery catheter 681 in a direction opposite to the depth direction. The height direction is opposite to the deflection direction of the distal-most section 722 to vary the height of the distal end of the delivery catheter (e.g., including the balloon or tip). In some examples, other height directions (e.g., offset from the plane of the distal-most section 722) can be utilized.

[0304] The proximal section 726 can be positioned distally and proximal to the proximal shaft 718. In examples, the order of the slotted sections can be varied as desired. For example, the high deflection section can include the middle section, and the secondary deflection section (in a plane transverse to the height) can include the proximal section. Other variations can be provided in examples.

[0305] An assembly of pull tethers or pull wires may be used to actuate the elongated shaft 710 and deflect the curved portion of the hypotube 720 or outer sheath 712 . Figure 68 A perspective view of an assembly of pull tethers or pull wires that may be utilized is shown (for clarity, Figure 68 The outer sheath 712 is excluded).

[0306] Figure 68 The assembly shown in FIG includes a plurality of connectors, ring structures, or inserts 730, 732, 734, 736. The connectors, ring structures, or inserts 730, 732, 734 may include pull tether or pull wire connectors and may serve as attachment locations for pull tethers or pull wires. Insert 730 may include an attachment location for pull tether 738, insert 732 may include an attachment location for pull tether 740, and insert 734 may include an attachment location for pull tether 742.

[0307] Figure 69 A close-up perspective view of the distal-most insert 730 is shown. The insert 730 may include an outer flange or edge 744 that can abut and rest on the distal end of the distal-most slotted section 722. The outer flange or edge 744 can hinder proximal movement of the insert 730 when the tether 738 is pulled to apply proximal tension. The insert 730 may include an alignment feature 746, such as a tab coupled to the distal-most slotted section 722, which can rotationally align the insert 730 relative to the distal-most slotted section 722. In addition, torque can be transmitted through the alignment feature 746. In an example, other forms of alignment feature 746 can be utilized. The alignment feature 746 may include a groove or recess, wherein a finger or tab of the distal-most slotted section 722 engages the groove or recess. The finger or tab can be pressed into the groove or recess.

[0308] The insert may include a coupler 748, such as a post, that may be coupled to the distal portion 750 of the pull tether 738. The insert 730 may include a passage 752 for an axle or sheath (e.g., a central axle or central axle subassembly, a tether assembly or subassembly, a release assembly or subassembly, and / or a nose cone axle or subassembly) to pass through. In an example, the configuration of the insert 730 may vary.

[0309] Figure 70 A close-up perspective view of the first intermediate insert 732 is shown. The first intermediate insert 732 may be positioned between the most distal slotted section 722 and the intermediate slotted section 724. The first intermediate insert 732 may include a distal sleeve portion 754 and a proximal sleeve portion 756. The distal sleeve portion 754 is inserted into the proximal portion 722b of the most distal slotted section 722. The proximal sleeve portion 756 is inserted into the distal portion 724a of the intermediate slotted section 724. The distal sleeve portion 754 may include alignment features 758 that may be configured similar to the alignment features 746 shown in Figure 69 The proximal portion 757 may include alignment features 760 that may be configured similar to the alignment features 746 shown in Figure 69

[0310] The central portion of the first intermediate insert 732 may include an outer flange 761 that may be positioned between the most distal slotted section 722 and the intermediate slotted section 724. The outer flange 761 may butt against and rest on the distal end of the intermediate slotted section 724. The outer flange 761 may impede the proximal movement of the insert 732 when a proximal tension is applied by the pull tether 740.

[0311] The first intermediate insert 732 may include a coupler 762, such as a post, that may be coupled to the distal portion 764 of the pull tether 740.

[0312] Referring to Figure 68 , the second intermediate insert 734 may be configured similarly to the first intermediate insert 732, but is adapted to be coupled to the distal portion 766 of the pull tether 742. The second intermediate insert 734 may be positioned between the intermediate slotted section 724 and the proximal slotted section 726. The proximal insert 736 may be configured similarly to the first intermediate insert 732 and the second intermediate insert 734, but may lack the couplers 748, 762 for the pull tethers.

[0313] The pull tether or pull wire may include a distal pull tether 738 or pull wire having a distal portion 750 and a proximal portion (coupled to Figure 65 ​The retraction tether adapter 735) shown in. The retraction tether 738 can extend along the length of the outer sheath 712. The distal portion 750 can be coupled to the outer sheath 712, as Figure 69 shown, and extends proximally from the point of connection or attachment to the retraction tether adapter 735. The retraction tether 738 can pass through the lumens in the inserts 732, 734, 736 to extend to the retraction tether adapter 735. The distal portion 750 of the distal retraction tether 738 is coupled to the distal portion 722a of the distal slotted portion 722.

[0314] The connection of the distal portion 750 of the retraction tether 738 to the coupler 748 can be a loop connection as Figure 69 shown, where the length of the retraction tether 738 loops around the coupler 748. The looped retraction tether 738 can be crimped to itself, or the looped length of the retraction tether 738 can extend proximally along the length of the outer sheath 712 to the retraction tether adapter 735.

[0315] A lumen in the form of a compression coil 770 can surround at least a portion of the retraction tether 738 between the first intermediate insert 732 and the second intermediate insert 734. The compression coil 770 can operate in a similar manner to that disclosed with respect to the compression coil 130 and can help reduce the deflection of the intermediate slotted section 724 when the distal slotted section 722 deflects. The compression coil 770 can include a distal portion 772 and a proximal portion 774, where the distal portion 772 is adapted to butt against the first intermediate insert 732 and the proximal portion 774 is adapted to butt against the second intermediate insert 734. The compression coil 770 has a larger diameter than the retraction tether 738 and can thus be sized not to pass through the lumens of the first intermediate insert 732 and the second intermediate insert 734. The compression coil 770 is positioned proximal to the proximal portion 722b of the distal slotted portion 722.

[0316] A compression coil 776 can surround at least a portion of the retraction tether 738 between the second intermediate insert 734 and the proximal insert 736. The compression coil 776 can operate in a similar manner to that disclosed with respect to the compression coil 130 and can help reduce the deflection of the proximal slotted section 726 when the distal slotted section 722 deflects. The compression coil 776 can include a distal portion 778 and a proximal portion 780, where the distal portion 778 is adapted to butt against the second intermediate insert 734 and the proximal portion 780 is adapted to butt against the proximal insert 736. The compression coil 776 is sized not to pass through the lumens of the second intermediate insert 734 and the proximal insert 736. The compression coil 776 is positioned proximal to the proximal portion 724b of the intermediate slotted section 724.

[0317] Tube 782 or hypotube can surround at least a portion of the distal pull tether 738 between the proximal insert 736 and the housing 784 or rail adapter to which the outer sheath 712 is coupled. Tube 782 can include a distal portion 786 and a proximal portion (extending to Figure 65 The distal end portion 786 of the tube 782 is adapted to engage the proximal side insert 736.

[0318] The proximal end portion of the tether 738 can be coupled to a tether adapter 735. The tether adapter 735 is adapted to slide longitudinally along the handle 682, either proximally to create axial tension in the tether 738 or distally to release or reduce axial tension. The tether adapter 735 engages a control knob or flexure knob 694A, wherein the flexure knob 694A has a threaded coupling to the outer surface of the handle 682 and a non-threaded rotational coupling or a fixed rotational coupling to the tether adapter 735. Thus, rotation of the flexure knob 694A moves the knob 694A proximally or distally, thereby moving the tether adapter 735 proximally or distally for applying or releasing axial tension in the tether 738. A deflection actuator or actuator assembly, including a deflection knob 694A and a pull tether adapter 735, applies tension to the pull tether 738 to deflect the elongated shaft 710. The elongated shaft 710 bends at a curved portion or distal slotted portion 722. In an example, the deflection actuator or actuator assembly can be used to axially push the pull tether 738 distally to actively deflect the guide shaft.

[0319] The pull tether or pull wire may include an intermediate pull tether 740 or pull wire having a distal portion 764 and a proximal portion (coupled to Figure 65 The pull tether adapter 790 shown in FIG. 7 ). The pull tether 740 can extend along the length of the outer sheath 712. The distal portion 764 can be coupled to the outer sheath 712, such as Figure 70 740 and extends proximally from the coupling or attachment point to the pull tether adapter 790. The pull tether 740 can be passed through the lumens in the inserts 734, 736 to extend to the pull tether adapter 790. The distal end portion 764 of the middle pull tether 740 is coupled to the distal end portion 724a of the middle slotted portion 724.

[0320] The connection between the distal end portion 764 of the pull tether 740 and the connector 762 can be a loop connection, such as Figure 70 Pull tether 740 may be coupled in a similar manner to pull tether 738 .

[0321] Reference again Figure 68A lumen in the form of a compression coil 800 can surround at least a portion of the pull tether 740 between the second intermediate insert 734 and the proximal insert 736. The compression coil 800 can operate in a manner similar to that disclosed with respect to the compression coil 130 and can help reduce deflection of the proximal slotted section 726 when the intermediate slotted section 724 deflects. The compression coil 800 can include a distal portion 802 and a proximal portion 804, wherein the distal portion 802 is adapted to interface with the second intermediate insert 734 and the proximal portion 804 is adapted to interface with the proximal insert 736. The compression coil 800 has a larger diameter than the pull tether 740 and can therefore be sized so as not to pass through the lumens of the second intermediate insert 734 and the proximal insert 736. The compression coil 800 is positioned proximal to the proximal portion 724b of the intermediate slotted section 724.

[0322] Tube 810 or hypotube can surround at least a portion of the pull tether 740 between the proximal insert 736 and the rail adapter to which the housing 784 or outer sheath 712 is coupled. Tube 810 can include a distal portion 812 and a proximal portion (extending to Figure 65 The distal end portion 812 of the tube 810 is adapted to engage the proximal side insert 736.

[0323] The proximal end portion of the intermediate pull tether 740 may be coupled to a pull tether adapter 790 (at Figure 65 ( hereinafter referred to as "tether adapter 790") is adapted to slide longitudinally along handle 682, either proximally to create axial tension in the intermediate tether 740 or distally to release or reduce axial tension. Tether adapter 790 engages a control knob or flex knob 694B, wherein flex knob 694B has a threaded connection to the outer surface of handle 682 and a non-threaded rotational connection to tether adapter 790. Thus, rotation of flex knob 694B moves knob 694B proximally or distally, thereby moving tether adapter 790 proximally or distally, thereby applying or releasing axial tension in tether 740. A deflection actuator or actuator assembly, including flex knob 694B and tether adapter 790, applies tension to tether 740 to deflect elongated shaft 710. Elongated shaft 710 bends at curved portion or intermediate slotted portion 724. The elongated shaft 710 deflects in a plane that is transverse or perpendicular to the deflection plane of the distal slotted section 722 .

[0324] The pull tether or pull wire may include a proximal pull tether 742 or pull wire having a distal portion 820 and a proximal portion (coupled to the distal portion). Figure 65 The pull tether 742 can extend along the length of the outer sheath 712. The distal portion 820 can be used withFigure 70 coupled to the outer sheath 712 in a similar manner as shown, and extending proximally from the coupling point or attachment point to the knob assembly 696. The pull cord 742 can extend through a lumen in the proximal insert 736 to reach the knob assembly 696. The knob assembly 696 can actuate the pull cord 742 to bend the elongate shaft 710 to change the height of the distal portion of the delivery catheter (e.g., including a balloon or tip).

[0325] The connection of the distal portion 820 of the pull cord 742 to the coupler of the second intermediate insert 734 can be a loop connection similar to the connection shown in Figure 70 . The distal portion 820 of the proximal pull cord 742 is coupled to the distal portion 726a of the proximal slotted portion 726.

[0326] Referring again to Figure 68 , the tube 830 or hypotube can surround at least a portion of the pull cord 742 between the proximal insert 736 and the rail adapter to which the outer housing 784 or outer sheath 712 is coupled. The tube 830 can include a distal portion 832 and a proximal portion (extending into the outer housing 784 or rail adapter shown in Figure 65 ). The distal portion 832 of the tube 810 is adapted to abut the proximal insert 736.

[0327] Applying tension to the proximal pull cord 742 deflects the elongate shaft 710 in the plane of deflection of the distal slotted section 722, but in the opposite direction. The tension can create height in a direction opposite to the depth of the delivery catheter 681.

[0328] Variations in the configuration of the components shown in Figures 67 to 70 can be provided. Figures 71 to 75 For example, variations are shown in which lumens in the form of tubes 782, 810 dock corresponding compression coils 800, 840. The distal portions 786, 812 of the respective tubes 782, 810 dock the respective proximal portions 842, 804 of the compression coils 840, 800. Unless otherwise stated, the features of the components shown in Figures 67 to 70 apply to the features of the components in Figures 71 to 75 .

[0329] The lumen or compression coil 800 may not be directly connected to the outer sheath 712 and may slide relative to the pull cord 740. The tube 810 may not be directly connected to the outer sheath 712 and may slide relative to the pull cord 740. A force applied to the compression coil 800 (e.g., by the insert 734′, or via other forces on the compression coil 800) can be transmitted through the tube 810 via the docking contact between the compression coil 800 and the tube 810. The compression coil 800 can extend the length of the proximal slotted section 726 before contacting the tube 810.

[0330] See Figure 72 , the insert 734' includes Figure 68 a variation of the second intermediate insert 734 shown in . The insert 734' includes a channel 852 for the compression coil 840 to extend through. The channel 852 is larger in size than the lumen 854 for the pull wire 740 to pass through and has a larger diameter for the compression coil 840 to pass through.

[0331] The lumen or compression coil 840 includes a compression coil having the Figure 68 lengths of the coils 770, 776 shown in and continuously extends from the first intermediate insert 732' to the position of the proximal insert 736'. The features of the compression coils 770, 776 are additionally applicable to the compression coil 840. The compression coil 840 may not be directly connected to the outer sheath 712 and may slide relative to the pull tether 738. The tube 782 may not be directly connected to the outer sheath 712 and may slide relative to the pull tether 738. (For example, by the insert 732', or via other forces on the compression coil 840) The force applied to the compression coil 840 may be transmitted through the tube 782 via butt contact between the compression coil 840 and the tube 782. The compression coil 840 may extend the length of the proximal slotted section 726 and the intermediate slotted section 724 before contacting the tube 782.

[0332] The inserts 730', 732', 734', 736' may include Figure 68 variations of the corresponding inserts 730, 732, 734, 736 shown in . The inserts 730', 732', 734' may each include corresponding molded sleeves 841, 843, 845 having corresponding plates or flanges 847, 849, 851 that engage the outer sheath 712. The insert 736' may lack a molded sleeve and may include a plate or flange for the docking tube 830. The features of the inserts 730, 732, 734, 736 are otherwise applied to the inserts 730', 732', 734', 736'.

[0333] Figure 73 The configuration of the housing 784 or rail adapter to which the proximal portion 716 of the outer sheath 712 is coupled is shown. The proximal portions of the tubes 782, 810, 830 are shown.

[0334] The housing 784 or rail adapter may be slidably engaged with the proximal portion 716 of the outer sheath 712. For example, the outer sheath adapter 870 may be coupled to the proximal portion 716 of the outer sheath 712 in a fixed and non-movable manner. Thus, the outer sheath adapter 870 may longitudinally or axially move in accordance with the force applied to the outer sheath 712 as the outer sheath 712 longitudinally or axially moves. The outer sheath adapter 870 may include alignment features 871 (e.g., timed or keyed protrusions) that may align the outer sheath adapter 870 with the housing 784 or rail adapter. The alignment features 871 may maintain the rotational orientation of the outer sheath 712 and may be used to transfer torque in an example.

[0335] Figure 74 A perspective view of the housing 784 or rail adapter is shown, where, for clarity, the outer sheath adapter 870 is removed from the view. The housing 784 includes a receiver 880 for slidably engaging with the outer sheath adapter 870. The housing 784 may include an alignment receiver 882 or slot for receiving the alignment feature 871. The alignment feature 871 may slide within the alignment receiver 882 or slot. The sliding motion may be an axial motion longitudinal to the axis of the outer sheath 712. The alignment feature 871 may prevent the outer sheath 712 from rotating about the axis.

[0336] The housing 784 or rail adapter may include a support plate 890 that includes one or more openings 892 for pulling the tethers 738, 740, 742 therethrough. The openings 892 may be positioned to be rotationally aligned with the positions of the pulling tethers 738, 740, 742 to allow the pulling tethers 738, 740, 742 to pass proximally to their respective actuator assemblies. The openings 892 may be sized such that the proximal portions of the respective lumens or tubes 782, 810, 830 do not pass through the support plate 890. The support plate 890 includes a surface 894 for butting the proximal portions of the tubes 782, 810, 830. In an example, the surface 894 may include a countersink or annular ring for receiving each of the proximal portions of the tubes 782, 810, 830. In an example, multiple plates may be stacked on one another to create a countersink or annular ring (with a proximal plate having a smaller hole diameter than the distal plate to form a countersink or annular ring).

[0337] The support plate 890 is fixedly coupled to the housing 784 or held in a non-moving configuration within the housing 784. Accordingly, a proximal force applied to any of the compression coils 840, 800 or tubes 782, 810, 830 is borne by the support plate 890. The support plate 890 has sufficient strength to support the loads generated on the compression coils 840, 800 or tubes 782, 810, 830 due to actuation of any of the pull tethers 738, 740, 742. The force applied to the compression coil 840 is transmitted to the support plate 890 through the tube 782, for example. The force applied to the compression coil 800 is transmitted to the support plate 890 through the tube 810, for example. The lack of a direct connection between the respective lumens in the form of the compression coils 840, 800 and tubes 782, 810, 830 and the outer sheath 712 allows the force to be transmitted and borne by the support plate 890.

[0338] The sliding engagement of the housing 784 with the proximal portion 716 of the outer sheath 712 allows the outer sheath 712 to slide relative to the support plate 890. Accordingly, a force receivable by the outer sheath 712 can create movement of the outer sheath 712 relative to the housing 784 to reduce the likelihood of adverse compression or damage to the outer sheath 712 during actuation of any of the pull tethers 738, 740, 742.

[0339] The force borne by the support plate 890 and the sliding movement of the outer sheath 712 relative to the housing 784 can reduce the presence of crosstalk or interference between the actuation of the respective pull tethers 738, 740, 742. The actuating force of the pull tether 738 can be borne by the support plate 890 rather than the intermediate slotted portion 724, for example, thereby reducing the deflection of the intermediate slotted portion 724 (and the proximal slotted portion 726) when the distal slotted portion 722 deflects. Similarly, the actuating force of the pull tether 740 can be borne by the support plate 890 rather than the proximal slotted portion 726, thereby reducing the deflection of the proximal slotted portion 726 when the intermediate slotted portion 724 deflects.

[0340] Figure 75 is shown Figure 73 and 74 a cross-sectional view of the components of. Figures 73 to 75 The components of can be integrated into the handle 682. For example, Figure 76 is shown in a representative configuration. Accordingly, the handle 682 can receive the support plate 890, the housing 784 or the rail adapter and actuator assembly (in the form of the control knobs or flex knobs 694A, 694B and the respective adapters 735, 790). The sliding engagement of the housing 784 or the rail adapter with the proximal portion 716 of the outer sheath 712 allows the outer sheath 712 to slide relative to the handle 682 (specifically, the second housing 686 of the handle 682).

[0341] As Figures 73 to 75The configuration shown in can be used with components such as Figure 71 and 72 shown, or with components such as Figures 67 to 70 shown.

[0342] Figures 67 to 76 Any of the features of can be used alone or in combination with each other, or in combination with any other examples disclosed herein.

[0343] In an example, an actuator assembly for pulling tethers 738, 740 or a variation of the deflection actuator can be provided. Figures 77 to 80 A variation is shown in which actuator assemblies 900, 902 are utilized and configured to apply tension to corresponding pulling tethers 738, 740 and simultaneously apply a distal compressive force to corresponding lumens (tubes 782, 810 and / or compression coils 840, 800).

[0344] Cross-sectional views of the corresponding distal or primary actuator assembly 900 and the intermediate or secondary actuator assembly 902 are shown in Figure 77 The distal or primary actuator assembly 900 includes a flexing knob or control knob 904. The flexing knob or control knob 904 is not threadedly engaged with the outer surface of the handle of the delivery system. Instead, the handle (having a second housing 906 corresponding to the second housing 686) lacks a threaded engagement with the flexing knob or control knob 904.

[0345] The flexing knob or control knob 904 engages a tether adapter 910 with a fixed rotary coupling (e.g., a non-threaded coupling) that allows the control knob 904 to rotate relative to the tether adapter 910 and apply a longitudinal or axial force to the tether adapter 910. The tether adapter 910 moves longitudinally with the control knob 904. The tether adapter 910 is coupled to the proximal portion of the pulling tether 738 in a manner similar to the tether adapter 735.

[0346] The flexing knob or control knob 904 engages a lumen adapter 912 with a threaded rotary coupling. Thus, rotation of the control knob 904 causes the lumen adapter 912 to slide longitudinally, where a first rotational direction produces longitudinal retraction and a second direction produces longitudinal advancement.

[0347] The lumen adapter 912 is adapted to contact the proximal end of the tube 782. Thus, the length of the tube 782 can be greater than the length in the example shown in Figures 73 to 75 and the use of the support plate 890 can be excluded. The lumen adapter 912 can directly contact and mate with the proximal end of the tube 782.

[0348] The fixed rotational coupling with the retraction tether adapter 910 and the threaded rotational coupling with the lumen adapter 912 cause rotation of the control knob 904 to change the spacing 914 between the lumen adapter 912 and the retraction tether adapter 910. Rotation in a first direction can increase the spacing 914, and rotation in the opposite direction can decrease the spacing 914. Thus, rotation of the control knob 904 in a single direction longitudinally drives the retraction tether adapter 910 and the lumen adapter 912 in opposite directions.

[0349] The compression coil 840 and the tube 782 can be in the configuration as discussed with respect to Figure 71 and 72 . Thus, a distal force applied to the tube 782 can be transmitted to the compression coil 840 and the insert 732'. Accordingly, the tube 782 and the compression coil 840 can be stiffened, and the likelihood of deflecting the intermediate slotted portion 724 (and the proximal slotted portion 726) can be reduced. Crosstalk between the deflection of one of the slotted portions and the deflection of the other of the slotted portions can be reduced. The actuator assembly 900 is adapted to simultaneously apply tension to the retraction tether 738 that is equal and opposite to the distal compressive force applied to the lumen (e.g., the compression coil 840 and the tube 782).

[0350] Figure 78 and 79 illustrate an exemplary operation of the actuator 900. Referring to Figure 78 , the lumen adapter 912 and the retraction tether adapter 910 are at a spacing 914 from each other. In Figure 79 , the control knob 904 has been rotated to increase the spacing 914 from each other. The retraction tether adapter 910 has been retracted to retract the retraction tether 738 and correspondingly deflect the distal slotted portion 722. The tube 782 and the compression coil 840 have a distal compressive force applied by the lumen adapter 912 that is transmitted to the first intermediate insert 732'. Accordingly, the proximal portion of the outer sheath 712 is stiffened, and the likelihood of crosstalk is reduced. The control knob 904 can be rotated in the opposite direction to reduce the tension in the retraction tether 738 and the compressive force against the insert 732'.

[0351] In an example, the threads and non-threads can be alternated such that the control knob 904 has a threaded engagement with the retraction tether adapter 910 and a non-threaded or fixed rotational coupling with the lumen adapter 912.

[0352] The intermediate or secondary actuator assembly 902 may include components of the distal or primary actuator assembly 900 and may operate in a similar manner. For example, the intermediate or secondary actuator assembly 902 may include a lumen adapter 920 that interfaces with the proximal portion of the tube 810 and a pull tether adapter 922 that couples to the proximal portion of the pull tether 740. The features of the distal or primary actuator assembly 900 may be used with the intermediate or secondary actuator assembly 902.

[0353] In an example, the configuration of the lumen can be varied so that the compression coil extends along the length of the outer sheath 712 and contacts the lumen adapters 912, 920. In an example, the compression coil can be eliminated and the tubes 782, 810 can extend distally to the inserts 732', 734'. Other configurations can be used in an example. In an example, the compression coils disclosed herein can include a compression tube with a cutout that allows the compression tube to flex or deflect. A cut compression hypotube can include a lumen that can be used instead of or in combination with a compression coil.

[0354] Figure 80 An exterior side view of the actuator assemblies 900 , 902 on the second housing 906 is shown.

[0355] Figures 77 to 80 Any of the features may be used alone or in combination with each other, or with any other examples disclosed herein.

[0356] refer to Figure 65 and 66 The elongated shaft 710 or rail shaft or subassembly can be coupled to the second housing 686 (alternatively referred to as the rail housing). The first housing 684 can slide longitudinally or axially relative to the second housing 686. The first housing 684 can be coupled to other shafts or sheaths of the delivery system 680, such as the outer shaft sheath or subassembly 20, the middle shaft or middle shaft subassembly 24, the tether assembly or subassembly 26, the release assembly or subassembly 28, and the nose cone shaft or subassembly.

[0357] As disclosed herein, the elongated shaft 710 or rail shaft or subassembly can form a curved portion of the elongated shaft of the delivery catheter (including the combination of components 20, 24, 26, 28). Sliding movement of the first housing 684 relative to the second housing 686 can advance or retract the components 20, 24, 26, 28 relative to the curved portion to change the depth of the distal end portion of the elongated shaft of the delivery catheter relative to the curved portion of the elongated shaft 710 or rail shaft or subassembly. The first housing 684 and components 20, 24, 26, 28 can be advanced distally relative to the second housing 686 to create depth, and the first housing 684 and components 20, 24, 26, 28 can be retracted proximally relative to the second housing 686 to reduce depth.

[0358] The knob assembly can be used to vary the depth of the distal portion of the elongate shaft of the delivery catheter relative to the elongate shaft 710 or the curved portion of the guide rail shaft or subassembly. The knob assembly can also be configured to actuate the height of the elongate shaft of the delivery catheter.

[0359] In an example, the knob assembly can be adapted to rotate in a first direction to create the depth of the distal portion of the elongate shaft of the delivery catheter relative to the elongate shaft 710 or the curved portion of the guide rail shaft or subassembly. The knob assembly can rotate in a second direction to create the height of the elongate shaft of the delivery catheter in a direction opposite to the depth. Figures 81 to 104 An example of a knob assembly that can be utilized is shown.

[0360] Figure 81 A cross-sectional view of an example of the knob assembly 696 is shown. The knob assembly 696 is positioned on the handle 682. The knob assembly 696 can include a first portion 930 or an inner body or a longitudinally fixed body. The knob assembly 696 can include a second portion 932 or an outer body or a longitudinally slidable body. The first portion 930 can include internal threads 934 adapted to engage threads 936 on the outer surface of the first housing 684. The first portion 930 can include external threads 937 adapted to engage the second portion 932. The first portion 930 can include a fixed rotational coupling 938 to the second housing 686 such that the first portion 930 is longitudinally fixed relative to the second housing 686.

[0361] The first portion 930 is adapted to rotate such that engagement with the threads of the first housing 684 causes the first housing 684 to longitudinally slide relative to the second housing 686. Accordingly, the depth of the distal portion of the delivery catheter varies relative to the elongate shaft 710 or the curved portion of the guide rail shaft or subassembly.

[0362] The second portion 932 includes internal threads 940 adapted to engage the external threads 936 of the first portion 930. Accordingly, rotation of the second portion 932 relative to the first portion 930 causes the second portion 932 to advance or retract relative to the first portion 930. The second portion 932 includes a fixed rotational coupling 942 having a tether adapter 946 for a proximal retraction tether 742 (e.g., marked in Figure 68 and 71 ). The second portion 932 includes a grip portion or control knob of the knob assembly 696 adapted for user grasping and manipulation. The outer surface 956 of the second portion 932 is adapted for grasping and manipulation.

[0363] The proximal pull tether assembly includes a proximal pull tether 742 and a pull tether adapter 946. The distal portion 820 of the proximal pull tether 742 is coupled to the elongate shaft of the delivery catheter, particularly to the elongate shaft 710 or a guide rail shaft or subassembly. The distal portion 820 may be coupled to the insert 734, 734', as disclosed herein. The proximal portion of the proximal pull tether 742 engages the pull tether adapter 946. Proximal movement of the pull tether adapter 946 creates the height of the elongate shaft 710 or the guide rail shaft or subassembly and thus the height of the elongate shaft of the delivery system. Distal movement of the pull tether adapter 946 reduces the tension and reduces the height.

[0364] The first portion 930 engages the second portion 932 such that the first portion 930 rotates with the second portion 932, and the second portion 932 is adapted to be released from the first portion 930 to permit rotation of the second portion 932 relative to the first portion 930. For example, a latch mechanism 950 (labeled in Figure 83 may be used to engage the first portion 930 with the second portion 932. The latch mechanism 950 may include a detent or other form of mechanism to maintain the first portion 930 and the second portion 932 in rotational engagement and permit release. The latch mechanism 950 may be adapted to be actuated with torque. Figure 83 For example, a form of the latch mechanism 950 is shown that includes a protrusion 952 on the first portion 930 that engages a recess 954 of the second portion 932 (alternatively, the first portion 930 may include a recess and the second portion 932 may include a protrusion 952). The protrusion 952 may be deflectable and is adapted to disengage from the recess 954 when sufficient torque is applied to the latch mechanism 950.

[0365] Figure 82 A cross-sectional view of the second portion 932 is shown. Figure 83 A perspective cross-sectional view of the second portion 932 is shown. Figure 84 A perspective cross-sectional view of the second portion 932 and the first portion 930 is shown. Figure 85 Shown from Figure 82 the side opposite the side shown in

[0366] Figures 86 to 93 An exemplary operation of the knob assembly 696 is shown. The delivery catheter is in Figure 86 and 87Shown in a depth configuration, wherein components 20, 24, 26, 28 of the elongate shaft 683 of the delivery catheter 681 are advanced distally relative to a bend portion 685 created by the elongate shaft 710 or a guide rail shaft or subassembly. The distal portion 704 of the elongate shaft 683 is shown extending distally relative to the bend portion 685 or in a depth position. A corresponding indicator 957 on the handle 682 indicates the depth of the distal portion 704, wherein the distal end of the second housing 686 serves as a reference point for the indicator 957.

[0367] In a configuration such as Figure 86 and 87 shown, the knob assembly 696 can be rotated in a first direction to create depth of the distal portion 704 relative to the bend portion 685. The knob assembly 696 can be rotated such that the second portion 932 remains engaged with the first portion 930. The internal threads 934 of the first portion 930 longitudinally drive the threads 936 on the first housing 684 relative to the second housing 686 to create a depth change. Components 20, 24, 26, 28 of the elongate shaft 683 of the delivery catheter are advanced distally relative to the bend portion 685.

[0368] The knob assembly 696 can be rotated in a second opposite direction to decrease the depth of the distal portion 704. For example, referring to Figure 88 and 89 , the knob assembly 696 is rotated in a second direction to cause the first housing 684 to slide proximally relative to the second housing 686. Components 20, 24, 26, 28 of the elongate shaft 683 of the delivery catheter are retracted proximally relative to the bend portion 685 to decrease the depth.

[0369] In a configuration such as Figure 88 and 89 shown, due to the coupling of the latch mechanism 950, the first portion 930 remains engaged with the second portion 932. Thus, rotation of the second portion 932 continues to create rotation of the first portion 930, the rotation of which longitudinally drives the threads 936 on the first housing 684 relative to the second housing 686 to decrease the depth.

[0370] Rotation of the first portion 930 can continue until a desired point. The desired point can include a defined position having no depth (e.g., zero), as represented on the indicator 957 in Figure 88 . In an example, rotation of the first portion 930 can be set to a desired point where independent tension is desired to occur on the proximal draw tether 742. As needed, such a point can occur before or after the point having no depth. Tension on the proximal draw tether 742 deflects the proximal slotted portion 726 to create height.

[0371] For example, Figure 90 and 91A configuration that prevents further rotation of the first part 930 is shown. Stopping the rotation can be produced in various ways and, in an example, can include a termination or stopping point of the threads 936 on the first housing 684. The first part 930 can contact a stop or be mechanically stopped from rotating, but the user can continue to apply a rotational force to the second part 932. The applied torsional force overcomes the engagement of the latch mechanism 950, and the latch mechanism 950 releases the first part 930 from the second part 932. The second part 932 is adapted to rotate relative to the first part 930 along the external threads 937 of the first part 930.

[0372] The second part 932 can be rotated to increase the spacing between the first part 930 and the second part 932. The tether adapter 946 is driven proximally relative to the first part 930 to create tension in the proximal tether 742. The second part 932 slides the adapter 946 proximally relative to the handle 682 to create height. The height of the distal portion 704 of the elongate shaft 683 increases, as Figure 91 represented. An upward bend is created in a direction opposite to depth.

[0373] The second part 932 can continue to rotate independently of the first part 930 for a desired distance. For example, referring to Figure 92 , the second part 932 can continue to rotate to retract the tether adapter 946 proximally and continue to increase the height of the distal portion 704 of the elongate shaft 683.

[0374] The second part 932 can be rotated in the opposite direction along the external threads 937 of the first part 930 to decrease the height. The second part 932 can be rotated until the second part 932 re - engages with the first part 930. The latch mechanism 950 can re - engage. A configuration as shown in Figure 88 and 89 is produced.

[0375] Variations in the configuration of the knob assembly 696 can be provided. For example, Figures 94 to 98 a variation is shown where the latch mechanism is adapted to be overcome with a longitudinal force.

[0376] For example, Figure 94 a variation is shown that includes a knob assembly 960, where the second part 962 includes a shift body 964 or a third body adapted to be longitudinally displaced to release the latch mechanism 966.

[0377] The first part 968 of the knob assembly 960 includes the features of the first part 930 of the knob assembly 696. The first part 968 includes the first body of the knob assembly 960. The second part 962 of the knob assembly 960 includes the outer body 970 or the second body of the knob assembly 960, and the shift body 964. The outer body 970 surrounds a cavity 972 for the longitudinal displacement of the shift body 964 therein.

[0378] The shift body 964 includes alignment features 974 that rotationally align the shift body 964 with the outer body 970. The alignment features 974 include, for example, tabs ( Figure 96 shown in the figure), which are adapted to longitudinally slide within a groove 976 in the inner surface of the outer body 970.

[0379] The latching mechanism 966 may include ratchet surfaces 980 or friction surfaces on the shift body 964 and the first part 968, and a spring body 982 that longitudinally presses the ratchet surfaces 980 into engagement with each other. The force of the spring body 982 is adapted to be overcome with a longitudinal force to release the ratchet surfaces 980 from each other.

[0380] The shift body 964 includes a fixed rotational coupling 984 with the pull tether adapter 946.

[0381] Figure 95 A cross-sectional view of the knob assembly 960 on the handle 682 is shown. The first housing 684 includes a stop 986 that is adapted to contact the pull tether adapter 946 when the first housing 684 moves proximally relative to the pull tether adapter 946.

[0382] In use, the spring body 982 presses the ratchet surfaces 980 together such that the outer body 970 rotates with the first part 968. Thus, rotation of the outer body 970 causes the first part 968 to rotate and correspondingly drives the first housing 684 relative to the second housing 686 to change the depth as needed.

[0383] At a defined point of depth reduction (e.g., proximal movement of the first housing 684), the stop 986 contacts and presses the pull tether adapter 946 with a proximal longitudinal force to overcome the force of the spring body 982. Thus, the latching mechanism 966 is released, and the outer body 970 is able to rotate and move proximally independently of the first part 968. For example, Figure 97 shown is the displacement of the shift body 964 within the cavity 972 of the outer body 970.

[0384] The outer body 970 rotates around the external thread 983 of the first part 968 to drive the pull tether adapter 946 proximally. Due to the proximal retraction of the pull tether adapter 946, a height (such as Figures 90 to 93as shown). Figure 98 The proximal movement of the outer body 970 relative to the first portion 968 to retract the retraction tether adapter 946 is shown. At the desired time, the outer body 970 can be rotated in the opposite direction to reduce the height and re-engage the latch mechanism 966. A configuration as Figure 95 shown is produced.

[0385] Variations in the configuration of the knob assembly 696 can be provided. Figures 99 to 104 A variation is shown in which the retraction tether adapter 990 includes threads 992 to engage the threads 994 of the knob assembly 996 (marked in Figure 100 ).

[0386] Figure 99 A perspective view of the retraction tether adapter 990 is shown. The retraction tether adapter 990 is shaped such that the threads 992 extend within a notch or slot 998 in the first housing 684 (marked in Figure 100 ). The retraction tether adapter 990 has an oval shape, with the threads 992 positioned on the protruding end 1000 of the retraction tether adapter 990. The threads 992 are positioned to be engaged by the threads 994 of the knob assembly 996.

[0387] Referring to Figure 100 , the retraction tether adapter 990 is shown within the internal cavity 1002 of the handle. The threads 992 extend within the slot 998. The first housing 684 includes stoppers 1004, 1006, which include ends of the slot 998 adapted to contact and move the retraction tether adapter 990 at a desired time.

[0388] The knob assembly 996 is shown in Figure 100 as having a fixed rotational coupling 1008 to the second housing 686 and a threaded coupling to the threads 936 of the first housing 684. The knob assembly 996 is axially fixed relative to the second housing 686.

[0389] The threaded coupling between the threads 994 of the knob assembly 996 and the threads 936 of the first housing 684 allows the knob assembly 996 to rotate to advance or retract the first housing 684 relative to the second housing 686 (and thereby change the depth of the distal portion of the delivery catheter). In the configuration as Figure 100 shown, the knob assembly 996 can only be threadedly engaged with the first housing 684, thus allowing the knob assembly 996 to rotate to advance or retract the first housing 684. Upon retraction, the stopper 1004 at the distal end of the slot 998 pushes the retraction tether adapter 990 proximally together with the first housing 684.

[0390] At the desired point, as the retraction tether adapter 990 is retracted proximally, the threads 994 of the knob assembly 996 engage the threads 992 of the retraction tether adapter 990. Figure 101 For example, it is shown that both the threads 992 of the retraction tether adapter 990 and the threads 936 of the first housing 684 are engaged by the knob assembly 996. The retraction tether adapter 990 can be retracted proximally with the first housing 684. In an example, the thread pitch of the retraction tether adapter 990 is the same as the thread pitch of the first housing 684.

[0391] The threads 936 of the first housing 684 terminate at a distal position 1010. The knob assembly 996 can continue to engage both the threads 992 of the retraction tether adapter 990 and the threads 936 of the first housing 684 until the first housing 684 is retracted proximally to a distance where the threads 994 disengage from the threads 936 of the first housing 684. Figure 102 A position is shown before the threads 994 disengage from the threads 936 of the first housing 684.

[0392] Figure 103 The knob assembly 996 is shown disengaged from the threads 936 of the first housing 684. The threads 994 of the knob assembly 996 have moved to the distal position 1010 of the housing 684, which has no threads. The knob assembly 996 continues to engage the retraction tether adapter 990 to retract the retraction tether adapter 990 relative to the first housing 684. Due to the proximal retraction of the retraction tether adapter 990, a height is created (as Figures 90 to 93 shown). The knob assembly 996 is thus adapted to alternatively engage the threads 936 of the first housing 684 and the threads 992 of the retraction tether adapter 990 to slide the adapter 990 relative to the first housing 684. The threads 994 of the knob assembly 996 disengage from the threads 936 of the first housing 684 to slide the retraction tether adapter 990 relative to the first housing 684.

[0393] The retraction tether adapter 990 can continue to retract to the desired point. To reduce the height, the knob assembly 996 can be rotated in the opposite direction. The retraction tether adapter 990 can be advanced distally until it reaches the stop 1004. The retraction tether adapter 990 can be pressed distally against the stop 1004 to push the first housing 684 distally until the threads 936 of the first housing 684 re-engage the threads 994 of the knob assembly 996.

[0394] The knob assembly 996 can return to the configuration as Figure 102 shown. The knob assembly 996 can continue to rotate to create a depth, for example, as Figure 104As shown. In the examples herein, variations in the configuration of the knob assembly can be provided. In an example, a separating mechanism such as a spring or a magnet can be used to position the pull tether adapter 990 before the stop 1004 presses the pull tether adapter 990 proximally. The separating mechanism can be overcome by pressing the pull tether adapter 990 proximally by the stop 1004.

[0395] The knob assembly can beneficially allow a single knob assembly to operate both the depth and height of the elongate shaft of the delivery catheter. The user can easily rotate in a first direction to create depth and rotate in the opposite direction to decrease depth and create height. Intuitive control of depth and height can be achieved. Additional knobs may not be required to separately vary depth and height. In addition, the knob assembly disclosed herein can be utilized to control the position or timing at which height is created. The release of the latch mechanism or the position or timing of the sliding movement of the pull tether adapter relative to the housing can be set to produce the desired point at which height occurs. Improved control of the implant deployment procedure can be achieved.

[0396] Figures 86 to 104 Any of the features can be used individually or in combination with each other, or in combination with any other examples disclosed herein.

[0397] Figure 105 A perspective cross-sectional view of the proximal portion of the handle 682 is shown. The central axis adapter 136 is coupled to the first housing 684 and is fixed in place relative to the first housing 684. Thus, the central axis or central axis subassembly 24 travels as the first housing 684 moves.

[0398] The pull tether adapter 150 is coupled to the pull tether actuator 698 in the form of a control knob. The pull tether actuator 698 has a threaded coupling to the first housing 684 and a fixed rotational coupling to the pull tether adapter 150. Rotation of the pull tether actuator 698 about the first housing 684 produces proximal or distal movement of the pull tether adapter 150, which can be relative to the central axis or central axis subassembly 24 of the delivery system 680 or other shafts or sheaths as needed. Expansion of the implant can be controlled by the advancement (expansion) or retraction (contraction) of the pull tether actuator 698 and the pull tether adapter 150 along the elongate shaft of the delivery catheter. Advancement can cause the implant to expand relative to the distal pusher 138 of the central axis or central axis subassembly 24, and retraction can cause the implant to retract into the distal pusher 138 of the central axis or central axis subassembly 24.

[0399] The retracted portion 192 or proximal portion of the release assembly or subassembly 28 can be coupled to the release actuator 700 in the form of a control knob 701 (in Figure 64(middle marking). The control knob 701 can engage with the retracted portion 192 of the release assembly or sub-assembly 28 through a threaded connection with the ratchet mechanism 705. The ratchet mechanism 705 can allow a slight sequential rotation of the control knob 701 to gradually retract the release assembly or sub-assembly 28. The sequential rotation can allow for a controlled release of the implant from the delivery system through the sequential retraction of the release assembly or sub-assembly 28. The release tether of the release assembly or sub-assembly 28 retracts from the loop portion of the tether assembly. Thus, if needed, a doctor or technician can confirm the correct placement of the implant, where the release assembly or sub-assembly 28 retracts slowly. Other configurations can be used in the example.

[0400] In operation, the delivery catheter 681 can enter the patient's vasculature using the access methods disclosed herein (e.g., transfemoral, transjugular, etc.). The access as shown (e.g., transfemoral and percutaneous) can be utilized. Upon entry, the delivery catheter 681 can approach the right atrium via the inferior vena cava. In an example, entry via the superior vena cava can be used. Figure 26 As shown. Upon entry, the delivery catheter 681 can approach the right atrium via the inferior vena cava. In an example, entry via the superior vena cava can be used.

[0401] A guide rail shaft or sub-assembly as disclosed herein can be used to deflect the elongate shaft or shaft assembly 683 of the delivery catheter 681. Upon approaching the implant site, the mechanisms disclosed herein can be used to provide depth and / or height. Changes in depth and / or height can allow for the navigation and adjustment of structures within the vasculature. For example, height can allow for an enhanced alignment of the delivery catheter with the native tricuspid annulus. A height can be created within the right atrium to assist in navigating the geometry of the right atrium. Various other deflections of the delivery catheter 681 can be used to position the delivery catheter in a desired orientation.

[0402] The distal tip of the delivery catheter 681 can be deflected to align approximately perpendicular to the implant site, e.g., as shown. The methods disclosed herein can be utilized to increase the depth of the distal tip or distal portion. The depth can position the distal tip at the annulus of the tricuspid valve (or the annulus of the mitral valve in mitral valve implantation). Figure 27 As shown. The methods disclosed herein can be utilized to increase the depth of the distal tip or distal portion. The depth can position the distal tip at the annulus of the tricuspid valve (or the annulus of the mitral valve in mitral valve implantation).

[0403] At a desired point, the outer sheath shaft or sub-assembly can be retracted to at least partially expose a portion of the implant for deployment. The capsule of the outer sheath shaft or sub-assembly can be retracted. The implant pops out of the capsule. For example, Figure 28 a representative configuration is shown. The proximal portion of the implant can be held within the distal pusher 138 of the central axis or central axis sub-assembly at this time. The distal or ventricular anchor of the implant can be deployed to capture the leaflets of the native valve, e.g., as shown. Figure 28 Imaging (e.g., ultrasound and / or fluoroscopy) can be used to determine whether capture has occurred. Deployment can continue upon visualization of the capture of the leaflets.

[0404] To effect further expansion of the implant, the coupling tether actuator 698 can be actuated to allow the coupling tether 142 to expand to expand the implant. Figure 18 and 29 A representative configuration is shown. Imaging can confirm the desired placement of the implant.

[0405] When it is confirmed that the implant is in the desired position (e.g., the ventricular anchor or hook anchor is secured with the native valve leaflet and the implant is positioned within the annulus as desired), the release actuator 700 can be actuated. Thus, the implant can be ejected from the capsule when attached to the tether assembly (coupling tether 142) and then released from the tether assembly after being confirmed to be correctly placed within the native valve (e.g., the native atrioventricular valve).

[0406] Before actuating the release actuator 700, the implant can be recaptured by retracting the coupling tether 142. Thus, during the deployment process, if the position of the implant is undesirable, the coupling tether 142 can be retracted. If desired, the implant can be retracted into the distal pusher 138 of the central axis or central axis subassembly. Repositioning of the implant can occur and then re - release of the implant can be provided, or the deployment sequence can be aborted entirely.

[0407] Upon confirmation of correct placement, the release assembly or sub - assembly 28 can be retracted to release the implant from the delivery system. A configuration as shown in Figure 23 and 30 can be produced. The delivery system can be withdrawn with the implant remaining in place. For example, Figure 31 A representative configuration is shown. Other methods, systems, or devices can be utilized as needed. The method can vary as needed. Other methods and features of the delivery system are disclosed in International Application PCT / US2022 / 016150, titled "Delivery Systems for Replacement Heart Valves", filed on February 11, 2022, and published as International Publication WO 2022 / 174057 on August 18, 2022, the entire content of which is incorporated herein by reference for all purposes.

[0408] An internal guide wire lumen or sheath can also be provided as needed. Figure 106 For example, a side view of a guide wire lumen or sheath 1020 is shown. The guide wire sheath 1020 includes a shaft 1022 having an internal lumen 1024 (marked as in the cross - sectional view of Figure 107 ) through which a guide wire can pass. The internal lumen 1024 can extend to the tip 1026 of the nose body 1028, which tip is positioned at the distal end of the shaft 1022. The nose body 1028 can include asFigure 106 and 107 the cone shown in, or may have other configurations in the instance as needed.

[0409] The nose body 1028 may include a leading portion of the delivery catheter that traverses the vasculature of the patient's body.

[0410] In an instance, the guide wire 1030 (labeled in Figure 107 ) may initially be advanced to the implantation site (e.g., seated within a ventricle or other part of the heart), and the delivery catheter may extend along the guide wire 1030 to the implantation site. As the delivery catheter is advanced, the guide wire sheath 1020 slides along the guide wire 1030 (where the guide wire 1030 is positioned within the inner lumen 1024).

[0411] At some point in the procedure, it may be desirable to retract the guide wire 1030 proximally into the tip 1026 of the nose body 1028 such that the tip 1032 of the guide wire 1030 is within or near the distal end 1034 of the guide wire sheath 1020. This feature can be used if movement or deflection of the delivery catheter is desired without interference from the guide wire 1030 protruding from the distal end 1034 of the guide wire sheath 1020.

[0412] A problem that may arise from retracting the guide wire 1030 into or near the tip 1026 is the subsequent advancement or distal movement of the guide wire 1030. The diameter 1036 of the inner lumen 1024 of the shaft 1022 may be narrow or close to the diameter of the guide wire 1030. Thus, advancement or distal movement of the guide wire 1030 relative to the distal end 1034 of the guide wire sheath 1020 can result in a non-flexible tip 1032 of the guide wire 1030 because the inner lumen 1024 of the shaft 1022 restricts the guide wire 1030 to the longitudinal or axial shape of the inner lumen 1024. Thus, the guide wire 1030 (as Figure 107 marked by the dashed line in) may protrude with a non-flexible tip that can pierce or otherwise damage the surrounding tissue 1038 when advancing the guide wire 1030.

[0413] Figures 108 to 117 An instance is shown that is intended to address the problem of advancement or distal movement of the guide wire 1030. For example, Figure 108 a cross-sectional view of a guide wire sheath 1040 is shown that has a proximal portion 1042 and a distal end 1044 and an inner lumen 1046 for passing the guide wire 1030 therethrough. The inner lumen 1046 has a diameter 1048. The inner lumen 1046 is adapted for distal advancement or proximal retraction of the guide wire 1030.

[0414] The spacer body 1050 is positioned at the distal end 1044 of the guide wire sheath 1040. The spacer body 1050 includes an opening 1052 through which the guide wire 1030 projects.

[0415] The spacer body 1050 has a cavity 1054, the diameter 1056 of which is greater than the diameter 1048 of the inner lumen 1046 of the guide wire sheath 1040. The cavity 1054 is defined by an outer wall 1058 of the spacer body 1050, wherein the opening 1052 is positioned distally of the orifice 1060 of the spacer body 1050 for the guide wire 1030 to enter the cavity 1054. The orifice 1060 may be continuous with the inner lumen 1046 of the guide wire sheath 1040 such that the guide wire 1030 passes through the orifice 1060 from the inner lumen 1046 and into the cavity 1054. The opening 1052 is positioned at the distal end 1062 of the spacer body 1050. The distal end 1062 may include a contact surface 1064 for docking with a surface of, for example, tissue (such as cardiac wall tissue, chordae tendineae, leaflets, or other tissue) located around the implantation site. The spacer body 1050 may have various shapes as needed, such as the dome shape shown in Figures 108 to 115 or the conical shape shown in Figure 116 and 117 and other shapes as needed (such as cuboid, rectangular, triangular, etc.).

[0416] The distal end 1062 of the spacer body 1050 may be axially or longitudinally spaced from the proximal end 1066 of the spacer body 1050 such that the cavity 1054 extends an axial or longitudinal distance from the distal end 1044 of the guide wire sheath 1040.

[0417] The cavity 1054 may have various shapes and may include the dome shape shown in Figures 108 to 113 or other shapes (such as conical, rectangular, oval, etc.). The diameter 1056 of the cavity 1054 being greater than the diameter 1048 of the inner lumen 1046 of the guide wire sheath 1040 allows the guide wire 1030 to deflect within the cavity 1054. The deflection may be a lateral deflection as shown in Figure 109 Thus, the restriction of the inner lumen 1024 on the distal end or tip 1032 of the guide wire 1030 can be excluded.

[0418] Figure 109A cross-sectional view showing an exemplary operation of the spacer body 1050 is presented. The distal end 1062 or the contact surface 1064 of the spacer body 1050 may contact or be close to the tissue 1038. The guide wire 1030 may be advanced distally through the internal lumen 1046. When in contact with the tissue 1038, the tip 1032 of the guide wire 1030 is capable of deflecting or bending laterally within the cavity 1054 such that the tip 1032 of the guide wire 1030 does not pierce or otherwise damage the tissue 1038. The distal end 1062 or the contact surface 1064 may be spaced apart from the surface of the tissue 1038 such that the tip 1032 of the guide wire 1030 can slide laterally along the surface of the tissue 1038 to avoid piercing the tissue 1038. Thus, the likelihood of piercing or damage may be reduced. A similar result occurs if the distal end 1062 or the contact surface 1064 is spaced from the surface of the tissue 1038 and the guide wire 1030 is advanced to contact the tissue 1038. The cavity 1054 provides a deflection space.

[0419] Figure 110 A side perspective view showing the shaft 1068 of the guide wire sheath 1040 coupled to the spacer body 1050 is presented. The spacer body 1050 may include the nose body of a delivery catheter, including the leading portion or tip of the delivery catheter. The shaft 1068 of the guide wire sheath 1040 may extend proximally along the elongate axis of the delivery catheter and through the handle of the delivery catheter.

[0420] Variations in the configuration of the spacer body 1050 may be provided. Figure 111 For example, a variation is presented where the spacer body 1070 includes ridges 1072 that extend radially inwardly toward the cavity 1074. The ridges 1072 may assist in the lateral deflection of the guide wire 1030 by providing a laterally extending surface within the interior of the cavity 1074 for the guide wire 1030 to rest on.

[0421] Figure 112 A variation is presented where a sheath 1080 surrounds the shaft 1068 of the guide wire sheath 1040 and docks with the spacer body 1050. The sheath 1080 may stabilize the spacer body 1050 against lateral deflection. Figure 113 A side view of this configuration is presented.

[0422] Figure 114 A variation is presented where the spacer body 1090 includes a plurality of openings 1092 through which the guide wire projects. The spacer body 1090 may include at least one rib 1094 that separates the plurality of openings 1092.

[0423] In an example, one or more of the openings 1092 may be positioned on the sidewall 1096 of the spacer body 1090. The sidewall 1096 may extend distally to the distal end 1098 of the spacer body 1090. The guide wire 1030 may project laterally from the opening 1092 to allow the guide wire 1030 to exit the spacer body 1090 laterally, to further reduce the likelihood of piercing or otherwise damaging tissue due to the axial advancement of the guide wire 1030. Figure 115 shows Figure 114 a distal end view of the spacer body 1090 shown in

[0424] Figure 116 shows a variation where the distal end 1100 of the spacer body 1102 includes a conical tip, with an opening 1104 in the sidewall 1106 of the spacer body 1102. The guide wire 1030 exits the spacer body 1102 laterally. Figure 117 shows a variation where a plurality of openings 1110 are provided along the conical spacer body 1112 for the lateral exit of the guide wire 1030. The openings 1110 may be separated by ribs 1114.

[0425] In an example, further variations in the configuration of the spacer body may be provided. Additionally, it will be appreciated that Figures 106 to 117 any of the features of

[0426] the sheath or shaft or assembly of the delivery catheter 681 may be arranged as shown in the Figure 118 cross-sectional view taken laterally of Figure 118 . The guide wire sheath 1040 or nose cone shaft or sub-assembly may include an innermost sheath or layer, where the release assembly or sub-assembly 28 extends adjacent to the guide wire sheath 1040. The tether assembly or sub-assembly 26 may extend adjacent to the guide wire sheath 1040. The central shaft or central shaft sub-assembly 24 may surround such internal components. The guide rail shaft or sub-assembly or elongate shaft 710 may surround the central shaft or central shaft sub-assembly 24. The outer sheath shaft or sub-assembly 20 may surround the guide rail shaft or sub-assembly or elongate shaft 710. Other configurations of the sheath or shaft or assembly disclosed herein may be used in the configuration as shown in

[0427] For example, Figure 119 shows a variation according to the configuration as shown in Figures 60A to 61 . The flexible retention tether 658 surrounds the guide wire sheath 1040 or nose cone shaft or sub-assembly. The release assembly or sub-assembly 28 extends externally (or may extend internally in an example) of the flexible retention tether 658. Other configurations may be used in an example.

[0428] Figure 120Illustrates a configuration of a stabilizer assembly 1120 for a delivery catheter that can be used in the examples herein. The delivery catheter 681 can be stabilized, for example, Figure 62 in the configuration shown on the stabilizer assembly 1120. The stabilizer is for coupling with the handle of the delivery catheter to stabilize the delivery catheter during deployment of a prosthetic heart valve to an autologous valve (e.g., an autologous atrioventricular valve).

[0429] Figures 121 to 123 Illustrates an exemplary prosthetic valve that can be implanted in the body using the delivery systems and / or features described herein. Additional details of implants or prosthetic valves that can be utilized are disclosed in U.S. Provisional Application No. 63 / 436,051, filed Dec. 29, 2022, and U.S. Provisional Application No. 63 / 533,458, filed Aug. 18, 2023, the entire contents of each of these provisional applications are hereby incorporated by reference.

[0430] Figure 121 Illustrates a perspective view of a prosthetic valve 1280 that can be used in any of the examples herein. The prosthetic valve 1280 can include features of any other prosthetic valve or example disclosed herein.

[0431] The prosthetic valve 1280 includes one or more prosthetic valve leaflets 1282. The prosthetic valve leaflets 1282 can be positioned within the flow channel 1284 of the prosthetic valve 1280. The prosthetic valve leaflets 1282 are supported by a valve body 1286 and can extend radially inwardly from the valve body 1286 in the flow channel 1284. The prosthetic valve leaflets 1282 are disposed within the lumen of the valve body 1286 to permit unidirectional flow.

[0432] The valve body 1286 can include an inner body 1288 (labeled in Figure 122 ), and an outer body 1290. The inner body 1288 and / or the outer body 1290 are preferably in the form of a collapsible and re-expandable metal frame. Each frame can include a self-expanding frame, which can be made of a shape memory material (e.g., nitinol). Unless otherwise noted, the inner body 1288 can include features of other examples of inner bodies disclosed herein. The inner body 1288 can include an inner frame 1292 (labeled in [[ID=ID=19]] Figure 123 ). The inner frame 1292 supports the prosthetic valve leaflets 1282. The inner frame 1292 can include a plurality of struts separated by spaces or openings. The struts are preferably arranged to form rows of connected units.

[0433] The outer body 1290 can include a sealing body and can include an outer frame 1306 (labeled in Figure 123a sealing skirt 1308, an outer skirt, or a fabric skirt positioned on the outer frame 1306. The outer frame 1306 is radially positioned outside the inner frame 1292. The outer surface 1307 of the outer frame 1306 faces radially outward from the prosthetic valve 1280. The outer surface 1307 is adapted to press against the tissue of the native heart valve. The sealing skirt 1308 extends along the outer surface 1307 of the outer frame 1306.

[0434] The proximal portion 1314 of the outer frame 1306 may be coupled to the proximal portion 1299 of the inner frame 1292.

[0435] In an example, the outer frame 1306 has a tapered shape such that the downstream or distal portion 1316 has a smaller diameter than the intermediate portion 1322 of the outer frame 1306. For example, the intermediate portion 1322 may have a diameter in the range of about 35 millimeters to about 60 millimeters, where the distal portion 1316 has a smaller diameter.

[0436] The outer frame 1306 may include one or more grasping features 1173 disposed along the outer surface (in Figure 121 the marks). The features of the grasping features are disclosed in U.S. Provisional Application No. 63 / 436,051, filed December 29, 2022, and U.S. Provisional Application No. 63 / 533,458, filed August 18, 2023, the entire contents of each of which are hereby incorporated by reference. The grasping features may include barbs (or may have any other form capable of engaging surrounding tissue). The barbs are preferably disposed along the struts of the outer frame 1306. The barbs may extend through the sealing skirt 1308 for penetrating the tissue of the native heart valve.

[0437] The anchor 1304 is shaped for placement behind the native valve leaflets. The anchor may be formed in a hook shape, or may be a hook arm anchor or a ventricular anchor. The anchor 1304 may include the features of any other anchor disclosed herein. The anchor 1304 may be coupled to the distal portion 1300 of the inner frame 1292. The anchor 1304 is adapted to hook around the native valve leaflets (i.e., extend around the native valve leaflets) to assist in anchoring the prosthetic valve within the native valve. The balloon of the delivery system may be retracted to allow the anchor 1304 to rotate into place to press the native valve leaflets against the outer frame 1306.

[0438] The outer frame 1306 may include one or more connectors 1399 in the form of eyelets or suture eyelets for coupling to a coupling tether as disclosed herein. For example, the coupling tether may be in Figure 18 and 20through the suture eyelets in the configuration shown. Nine connectors 1399 are described in the examples; however, more or fewer numbers may be used as needed. The connectors 1399 can be positioned at the inlet end portion of the prosthetic valve 1280. The connectors 1399 can be positioned at the strut arm ends or tabs of the frame of the prosthetic valve 1280.

[0439] The prosthetic valve 1280 can be expanded at the implantation site and released from the delivery system using any of the methods disclosed herein. The frame of the prosthetic valve 1280 can be self-expanding and can be made of a shape memory material (e.g., nitinol) in the examples. In the examples, other materials can be utilized. The prosthetic valve 1280 can be adapted to be constrained in a compressed configuration and then released at the implantation site to self-expand.

[0440] Examples of prosthetic valves can be used in the tricuspid valve as disclosed herein, or can be used in other deployment locations, such as the native mitral valve or other deployment locations. Deployment to the aortic or pulmonary valves or other implantation sites is also contemplated and is considered to be within the scope of the present disclosure.

[0441] The delivery systems disclosed herein can be used with any of the examples disclosed herein.

[0442] Various modifications of the examples disclosed herein can be provided. Between the examples, the features of the examples can be modified, substituted, excluded, or combined as desired. Combinations of features between the examples can be provided as needed. Combinations of features between the examples can be provided and other features of such examples can be excluded as needed.

[0443] The various examples of the sealing skirts disclosed herein can have various forms, including cloth skirts, foam skirts, or braided skirts as needed. Various materials can be used as needed.

[0444] The implants disclosed herein can include prosthetic heart valves or other forms of implants, such as stents or filters, or diagnostic devices, etc. The implant can be an expandable implant configured to move from a compressed or undeployed state to a deployed or expanded state. The implant can be a compressible implant configured to compress inwardly to have a reduced outer profile and move the implant to a compressed or undeployed state.

[0445] Various forms of delivery devices can be used in the examples disclosed herein. The delivery devices disclosed herein can also be used for the replacement and repair of the aortic, mitral, tricuspid, and pulmonary valves. The delivery devices can include delivery devices for delivering other forms of implants, such as stents or filters, or diagnostic devices, etc.

[0446] The implants and systems disclosed herein can be used for transcatheter mitral or tricuspid valve implantation, as well as transcatheter aortic valve replacement (TAVR) or replacement of other native heart valves (e.g., pulmonary valve). The delivery devices and systems disclosed herein can be used for transarterial access (including transfemoral access) to a patient's heart. When used for transcatheter mitral valve replacement, the delivery procedure is preferably performed using a transseptal delivery technique, wherein the delivery catheter is advanced through a hole in the septum into the right atrium and then into the left atrium to access the native mitral valve. The delivery devices and systems can also be used for other transcatheter percutaneous procedures, including transarterial procedures, which can be transfemoral or transjugular. In addition, a transapical procedure can also be used. Other procedures can be used as needed.

[0447] In addition, the methods herein are not limited to the specifically described methods and can include methods utilizing the systems and devices disclosed herein. The steps of the methods can be modified, excluded, or added using the systems, devices, and methods disclosed herein. In an example, the examples disclosed herein can include systems for implantation into a human body.

[0448] For the purposes of this description, certain aspects, advantages, and novel features of the examples of the present disclosure are described herein. The disclosed methods, devices, and systems should not be construed as limiting in any way. Instead, the present disclosure relates to all novel and non-obvious features and aspects of the various disclosed examples, together and in various combinations and sub-combinations with each other. The methods, devices, and systems are not limited to any specific aspect or feature or combination thereof, and the disclosed examples do not require the presence of any one or more specific advantages or problem solutions. The features, elements, or combinations of one example can be combined into other examples herein.

[0449] Example 1: A delivery system for an implant, the delivery system comprising: an elongate shaft configured to advance the implant to an implantation site and including a proximal portion and a distal portion, at least a portion of the elongate shaft including a tether assembly, the tether assembly including: a plurality of coupling tethers configured to couple to the implant; a tether manifold configured to couple to the plurality of coupling tethers; and a flexible retention tether coupled to the tether manifold and extending proximally from the tether manifold.

[0450] Example 2: The delivery system according to any one of the examples herein, particularly Example 1, wherein the flexible retention tether includes one or more of a wire or a suture.

[0451] Example 3: The delivery system according to any one of the examples herein, particularly Example 1 or Example 2, wherein each of the coupling tethers includes a suture.

[0452] Example 4: The delivery system of any example herein, particularly examples 1 to 3, wherein each of the coupling tethers comprises a loop configured to pass through an opening in a portion of the implant.

[0453] Example 5: The delivery system of any example herein, in particular examples 1 to 4, wherein the plurality of attachment tethers comprises continuous sutures.

[0454] Example 6: The delivery system of any example herein, particularly example 5, wherein the continuous suture is looped at the tether manifold to form the plurality of connected tethers.

[0455] Example 7: The delivery system of any example herein, in particular examples 1 to 6, wherein the plurality of linked tethers are woven or braided with the tether manifold.

[0456] Example 8: The delivery system according to any example herein, in particular examples 1 to 7, wherein the flexible retention tether is woven or braided.

[0457] Example 9: The delivery system of any example herein, in particular examples 1 to 8, wherein at least one of the plurality of coupled tethers comprises a free end buried in the tether manifold or the flexible retention tether.

[0458] Example 10: The delivery system of any example herein, in particular example 9, wherein the free end is locked to the tether manifold or the flexible retention tether.

[0459] Example 11: The delivery system of any example herein, in particular examples 1 to 10, wherein at least one of the plurality of attachment tethers comprises a woven or braided loop.

[0460] Example 12: The delivery system of any example herein, particularly Example 11, wherein at least a portion of the tether manifold overlaps the woven or braided loop to couple the woven or braided loop to the tether manifold.

[0461] Example 13: The delivery system of any example herein, particularly example 11 or example 12, wherein the woven or braided loop forms at least two loops extending from the tether manifold and each configured to couple to the implant.

[0462] Example 14: A delivery system according to any example herein, particularly Examples 1 to 13, wherein the tether manifold comprises warp strands woven together with weft strands, and the plurality of connecting tethers comprise continuous portions of the warp strands of the tether manifold, the warp strands lacking weaving with any weft strands.

[0463] Example 15: The delivery system according to any one of the examples herein, particularly Example 14, wherein each of the plurality of coupling tethers includes a loop of a continuous portion of the warp yarns.

[0464] Example 16: The delivery system according to any one of the examples herein, particularly Example 14 or Example 15, wherein the tether manifold includes a vertical stack and a horizontal stack of the warp yarns.

[0465] Example 17: The delivery system according to any one of the examples herein, particularly Examples 1 to 16, wherein each of the plurality of coupling tethers includes a loop of yarns, and the tether manifold includes a fabric or a braid of the yarns of the plurality of coupling tethers.

[0466] Example 18: The delivery system according to any one of the examples herein, particularly Example 17, wherein the flexible retention tether includes a fabric or a braid of the yarns of the plurality of coupling tethers, and the flexible retention tether includes a proximal portion that includes free ends of the yarns of the plurality of coupling tethers.

[0467] Example 19: The delivery system according to any one of the examples herein, particularly Examples 1 to 18, further includes a release assembly for releasing the plurality of coupling tethers from the implant.

[0468] Example 20: The delivery system according to any one of the examples herein, particularly Examples 1 to 19, wherein the elongate shaft includes a sheath that extends over the flexible retention tether.

[0469] Example 21: The delivery system according to any one of the examples herein, particularly Examples 1 to 20, wherein the tether manifold is positioned at the distal portion, and the flexible retention tether extends proximally from the distal portion to the proximal portion.

[0470] Example 22: The delivery system according to any one of the examples herein, particularly Examples 1 to 21, wherein the proximal portion includes a housing for the elongate shaft.

[0471] Example 23: The delivery system according to any one of the examples herein, particularly Examples 1 to 22, wherein the elongate shaft includes a deflectable portion that is configured to deflect laterally with respect to a longitudinal axis of the elongate shaft.

[0472] Example 24: The delivery system according to any one of the examples herein, particularly Example 23, wherein the flexible retention tether is configured to deflect at the deflectable portion.

[0473] Example 25: The delivery system according to any one of the examples herein, particularly Example 23 or Example 24, further includes a control mechanism for controlling the deflection of the deflectable portion.

[0474] Example 26: The delivery system according to any one of the examples herein, particularly Examples 1 to 25, wherein the elongate shaft includes a sac for holding the implant.

[0475] Example 27: The delivery system according to any one of the examples herein, particularly Example 26, further includes a retraction mechanism for retracting the sac to release the implant from the sac.

[0476] Example 28: The delivery system according to any one of the examples herein, particularly Examples 1 to 27, further includes an implant, wherein the implant includes a prosthetic heart valve.

[0477] Example 29: The delivery system according to any one of the examples herein, particularly Example 28, wherein the prosthetic heart valve includes a plurality of fenestrations, and each of the coupling tethers is configured to pass through a corresponding one of the plurality of fenestrations.

[0478] Example 30: The delivery system according to any one of the examples herein, particularly Examples 1 to 29, wherein the flexible retention tether includes an internal lumen for the nasal cone shaft to extend therethrough.

[0479] Example 31: A method includes: delivering an implant to an autologous heart valve using a delivery system, wherein the delivery system includes: an elongate shaft for advancing the implant to the autologous heart valve and including a proximal portion and a distal portion, at least a portion of the elongate shaft including a tether assembly, the tether assembly including: a plurality of coupling tethers configured to be coupled to the implant; a tether manifold for coupling to the plurality of coupling tethers; and a flexible retention tether coupled to the tether manifold and extending proximally from the tether manifold.

[0480] Example 32: The method according to any one of the examples herein, particularly Example 31, wherein the flexible retention tether includes one or more of wire or suture.

[0481] Example 33: The method according to any one of the examples herein, particularly Example 31 or Example 32, wherein each of the coupling tethers includes a suture.

[0482] Example 34: The method according to any one of the examples herein, particularly Examples 31 to 33, wherein each of the coupling tethers includes a loop configured to pass through an opening in a portion of the implant.

[0483] Example 35: A method according to any one of the examples herein, particularly the method described in Examples 31 to 34, wherein the plurality of connecting tethers includes continuous sutures.

[0484] Example 36: A method according to any one of the examples herein, particularly the method described in Examples 31 to 35, wherein at least one of the plurality of connecting tethers includes a free end buried in the tether manifold or the flexible retaining tether.

[0485] Example 37: A method according to any one of the examples herein, particularly the method described in Example 36, wherein the free end is locked to the tether manifold or the flexible retaining tether.

[0486] Example 38: A method according to any one of the examples herein, particularly the method described in Examples 31 to 37, wherein at least one connecting tether includes a woven or braided loop.

[0487] Example 39: A method according to any one of the examples herein, particularly the method described in Example 38, wherein at least a portion of the tether manifold overlaps the woven or braided loop to couple the woven or braided loop to the tether manifold.

[0488] Example 40: A method according to any one of the examples herein, particularly the method described in Example 38 or Example 39, wherein the woven or braided loop forms at least two loops extending from the tether manifold and each configured to couple to the implant.

[0489] Example 41: A method according to any one of the examples herein, particularly the method described in Examples 31 to 40, wherein the tether manifold includes warp yarn strands woven with weft yarn strands, and the plurality of connecting tethers includes continuous portions of the warp yarn strands of the tether manifold, the warp yarn strands lacking weaving with any weft yarn strands.

[0490] Example 42: A method according to any one of the examples herein, particularly the method described in Example 41, wherein each of the plurality of connecting tethers includes a loop of the continuous portion of the warp yarn strand.

[0491] Example 43: A method according to any one of the examples herein, particularly the method described in Example 41 or Example 42, wherein the tether manifold includes vertical and horizontal stacks of the warp yarn strands.

[0492] Example 44: A method according to any one of the examples herein, particularly the method described in Examples 31 to 43, wherein each of the plurality of connecting tethers includes a loop of yarn, and the tether manifold includes a woven or braided fabric of the yarns of the plurality of connecting tethers.

[0493] Example 45: The method according to any one of the examples herein, particularly Example 44, wherein the flexible retention tether comprises a fabric or braid of the strands of the plurality of coupling tethers, and the flexible retention tether comprises a proximal portion that includes free ends of the strands of the plurality of coupling tethers.

[0494] Example 46: A delivery system for an implant, the delivery system comprising: an elongate shaft configured to advance the implant to an implantation site and comprising a proximal portion and a distal portion, at least a portion of the elongate shaft comprising a tether assembly and a release assembly, the tether assembly comprising one or more coupling tethers configured to be coupled to the implant, each coupling tether comprising a loop portion configured to project from a corresponding opening in a portion of the implant, and the release assembly comprising one or more release tethers configured to extend through one or more of the loop portions to hold the implant to the one or more loop portions, the one or more release tethers configured to retract from the one or more loop portions to release the implant from the one or more loop portions.

[0495] Example 47: The delivery system according to any one of the examples herein, particularly Example 46, wherein each release tether extends through a plurality of loop portions.

[0496] Example 48: The delivery system according to any one of the examples herein, particularly Example 46 or Example 47, wherein each release tether extends through at least three of the loop portions.

[0497] Example 49: The delivery system according to any one of the examples herein, particularly Examples 46 to 48, wherein the one or more release tethers comprise at least three of the release tethers.

[0498] Example 50: The delivery system according to any one of the examples herein, particularly Examples 46 to 49, wherein the one or more release tethers extend circumferentially between a plurality of loop portions.

[0499] Example 51: The delivery system according to any one of the examples herein, particularly Examples 46 to 50, wherein the one or more release tethers extend radially inwardly to a retention sheath of the release assembly.

[0500] Example 52: The delivery system according to any one of the examples herein, particularly Examples 46 to 51, wherein the elongate shaft comprises a sheath extending over at least a portion of the tether assembly.

[0501] Example 53: A delivery system according to any example herein, particularly examples 46 to 52, wherein the elongate shaft includes a sheath extending over at least a portion of the release assembly.

[0502] Example 54: A delivery system according to any example herein, particularly examples 46 to 53, wherein the release assembly extends proximally from the distal portion to the proximal portion.

[0503] Example 55: A delivery system according to any example herein, particularly examples 46 to 54, wherein the proximal portion includes a housing for the elongate shaft.

[0504] Example 56: A delivery system according to any example herein, particularly examples 46 to 55, wherein the elongate shaft includes a deflectable portion configured to deflect transversely to the longitudinal axis of the elongate shaft.

[0505] Example 57: A delivery system according to any example herein, particularly example 56, wherein at least a portion of the release assembly is configured to deflect at the deflectable portion.

[0506] Example 58: A delivery system according to any example herein, particularly examples 46 to 57, wherein the elongate shaft includes a sac for holding an implant.

[0507] Example 59: A delivery system according to any example herein, particularly examples 46 to 58, further comprising an implant, wherein the implant includes a prosthetic heart valve.

[0508] Example 60: A delivery system according to any example herein, particularly example 59, wherein the respective openings include respective fenestrations of the prosthetic heart valve.

[0509] Example 61: A method comprising: delivering an implant to an autologous heart valve using a delivery system, wherein the delivery system includes: an elongate shaft for advancing the implant to the autologous heart valve and including a proximal portion and a distal portion, at least a portion of the elongate shaft including a tether assembly and a release assembly, the tether assembly including one or more coupling tethers configured to be coupled to the implant, each coupling tether including a loop portion configured to protrude from a respective opening in a portion of the implant, and the release assembly including one or more release tethers configured to extend through one or more of the loop portions to hold the implant to the one or more loop portions, the one or more release tethers being configured to retract from the one or more loop portions to release the implant from the one or more loop portions.

[0510] Example 62: A method according to any example herein, particularly the method of Example 61, wherein each release tether extends through a plurality of loop portions.

[0511] Example 63: A method according to any example herein, particularly the method of Example 61 or Example 62, wherein each release tether extends through at least three of the loop portions.

[0512] Example 64: A method according to any example herein, particularly the method of Examples 61 to 63, wherein the one or more release tethers include at least three of the release tethers.

[0513] Example 65: A method according to any example herein, particularly the method of Examples 61 to 64, wherein the one or more release tethers extend circumferentially between the plurality of loop portions.

[0514] Example 66: A delivery system for an implant, the delivery system comprising: an elongate shaft configured to advance the implant to an implantation site and including a proximal portion and a distal portion; one or more coupling tethers, each coupling tether including a first portion and a second portion, the first portion being configured to couple to the implant to hold the implant to the elongate shaft; and a disintegration assembly configured to connect to the second portion of the one or more coupling tethers and disintegrate the connection to the second portion to release the implant from the elongate shaft.

[0515] Example 67: A delivery system according to any example herein, particularly the delivery system of Example 66, wherein the disintegration assembly includes a heating element for disintegrating the connection to the second portion.

[0516] Example 68: A delivery system according to any example herein, particularly the delivery system of Example 67, wherein the second portion of the one or more coupling tethers is connected to the heating element.

[0517] Example 69: A delivery system according to any example herein, particularly the delivery system of Example 67 or Example 68, wherein the heating element is configured to disintegrate the second portion of the one or more coupling tethers to disintegrate the connection to the second portion.

[0518] Example 70: A delivery system according to any example herein, particularly the delivery system of Examples 67 to 69, wherein the heating element includes a loop.

[0519] Example 71: A delivery system according to any example herein, particularly the delivery system of Examples 67 to 70, wherein the second portion of the one or more coupling tethers includes a loop extending over the heating element.

[0520] Example 72: A delivery system according to any example herein, particularly examples 67 to 71, wherein the disintegration assembly includes an intermediate body connected to a second portion of the one or more coupling tethers, and the heating element is configured to disintegrate the intermediate body to disintegrate the connection to the second portion.

[0521] Example 73: A delivery system according to any example herein, particularly examples 67 to 72, wherein the heating element includes a heating wire.

[0522] Example 74: A delivery system according to any example herein, particularly examples 67 to 73, wherein the disintegration assembly includes one or more electrical conduits for passing electrical energy through the heating element.

[0523] Example 75: A delivery system according to any example herein, particularly examples 67 to 74, wherein the disintegration assembly includes a power source for supplying power to the heating element.

[0524] Example 76: A delivery system according to any example herein, particularly examples 67 to 75, wherein the disintegration assembly includes a first electrical conduit and a second electrical conduit, the first electrical conduit extends along the elongate axis and has a first electrical terminal, the second electrical conduit extends along the elongate axis and has a second electrical terminal, the first electrical terminal is displaceable relative to a second electrical contact and is configured to contact the second electrical terminal to complete a circuit for passing electrical energy through the heating element.

[0525] Example 77: A delivery system according to any example herein, particularly examples 66 to 76, wherein the first portion of each of the one or more coupling tethers includes a loop portion configured to project from a corresponding opening in a portion of the implant.

[0526] Example 78: A delivery system according to any example herein, particularly examples 66 to 77, further comprising a tether manifold and a flexible retention tether, wherein the one or more coupling tethers are coupled to the tether manifold and the tether manifold is coupled to the flexible retention tether.

[0527] Example 79: A delivery system according to any example herein, particularly examples 66 to 78, further comprising an implant, wherein the implant includes a prosthetic heart valve.

[0528] Example 80: A delivery system according to any example herein, particularly example 79, wherein the prosthetic heart valve includes one or more eyelets for connection to the first portion of the one or more coupling tethers.

[0529] Example 81: A method includes: delivering an implant to an autologous heart valve using a delivery system, wherein the delivery system includes: an elongate shaft configured to advance the implant to the autologous heart valve and including a proximal portion and a distal portion; one or more coupling tethers, each coupling tether including a first portion and a second portion, the first portion being configured to couple to the implant to hold the implant to the elongate shaft; and a disintegration assembly configured to connect to the second portion of the one or more coupling tethers and disintegrate the connection to the second portion to release the implant from the elongate shaft.

[0530] Example 82: The method according to any example herein, particularly example 81, wherein the disintegration assembly includes a heating element for disintegrating the connection to the second portion.

[0531] Example 83: The method according to any example herein, particularly example 82, wherein the second portion of the one or more coupling tethers is connected to the heating element.

[0532] Example 84: The method according to any example herein, particularly example 82 or example 83, wherein the heating element is configured to disintegrate the second portion of the one or more coupling tethers to disintegrate the connection to the second portion.

[0533] Example 85: The method according to any example herein, particularly examples 82 to 84, wherein the heating element includes a ring.

[0534] Example 86: A delivery system for an implant, the delivery system comprising: a delivery catheter for advancing the implant to an implantation site, the delivery catheter comprising: an elongate shaft adapted to deflect in one or more planes, the elongate shaft having: an outer sheath having a distal portion and a proximal portion and a length; a pull tether having a distal portion and a proximal portion and extending along the length of the outer sheath, the distal portion being coupled to the outer sheath; a compression coil surrounding at least a portion of the pull tether and comprising a distal portion and a proximal portion, the compression coil not being directly connected to the outer sheath and being slidable relative to the pull tether; and a tube surrounding at least a portion of the pull tether and comprising a distal portion and a proximal portion, the tube not being directly connected to the outer sheath and being slidable relative to the pull tether, the distal portion of the tube being adapted to dock with the proximal portion of the compression coil; a support plate comprising an opening for the pull tether to pass through, the support plate being adapted to dock with the proximal portion of the tube; a housing slidably engaged with the proximal portion of the outer sheath; and an actuator assembly for applying tension to the pull tether to deflect the elongate shaft, whereby the force applied to the compression coil is transmitted through the tube to the support plate.

[0535] Example 87: The delivery system according to any one of the examples herein, particularly Example 86, wherein the elongate shaft is a guide rail shaft and the delivery catheter comprises one or more shafts adapted to slide relative to the guide rail shaft.

[0536] Example 88: The delivery system according to any one of the examples herein, particularly Example 87, wherein the one or more shafts are adapted to slide relative to the guide rail shaft to change the depth of the one or more shafts relative to the guide rail shaft.

[0537] Example 89: The delivery system according to any one of the examples herein, particularly Example 87 or Example 88, wherein the outer sheath comprises a curved portion configured to form a bend when the actuator assembly applies the tension to the pull tether.

[0538] Example 90: The delivery system according to any one of the examples herein, particularly Example 89, wherein the one or more shafts are adapted to slide relative to the bend to change the depth of the one or more shafts relative to the guide rail shaft.

[0539] Example 91: A delivery system according to any example herein, particularly examples 86 to 90, wherein the distal portion of the outer sheath includes a slotted portion having a proximal portion and a distal portion, and the distal portion of the pull tether is coupled to the distal portion of the slotted portion.

[0540] Example 92: A delivery system according to any example herein, particularly example 91, wherein the compression coil is positioned proximal to the proximal portion of the slotted portion.

[0541] Example 93: A delivery system according to any example herein, particularly examples 86 to 92, wherein the pull tether is a first pull tether, and the compression coil is a first compression coil, and the tube is a first tube, and tension on the first pull tether deflects the elongate shaft in a first plane, and the delivery system further comprises: a second pull tether having a distal portion and a proximal portion and extending along the length of the outer sheath, the distal portion of the second pull tether being coupled to the outer sheath; a second compression coil surrounding at least a portion of the second pull tether and including a distal portion and a proximal portion, the second compression coil not being directly connected to the outer sheath and being slidable relative to the second pull tether; and a second tube surrounding at least a portion of the second pull tether and including a distal portion and a proximal portion, the second tube not being directly connected to the outer sheath and being slidable relative to the second pull tether, the distal portion of the second tube being adapted to abut the proximal portion of the second compression coil; wherein the support plate includes an opening for the second pull tether to pass through, the support plate being adapted to abut the proximal portion of the second tube; and wherein tension applied to the second pull tether deflects the elongate shaft in a second plane transverse to the first plane.

[0542] Example 94: A delivery system according to any example herein, particularly example 93, further comprising: a third pull tether having a distal portion and a proximal portion and extending along the length of the outer sheath, the distal portion of the third pull tether being coupled to the outer sheath; and a third tube surrounding at least a portion of the third pull tether and including a distal portion and a proximal portion, the third tube not being directly connected to the outer sheath and being slidable relative to the third pull tether; wherein the support plate includes an opening for the third pull tether to pass through, the support plate being adapted to abut the proximal portion of the third tube; and wherein tension applied to the third pull tether deflects the elongate shaft in the first plane in a direction opposite to the direction in which the first pull tether deflects the elongate shaft.

[0543] Example 95: A delivery system according to any example herein, particularly Example 94, wherein the first pulling tether is coupled to the outer shaft at a location remote from the location where the second pulling tether is coupled to the outer shaft, and the second pulling tether is coupled to the outer shaft at a location remote from the location where the third pulling tether is coupled to the outer shaft.

[0544] Example 96: A delivery system according to any example herein, particularly Examples 86 to 95, further comprising a handle for receiving a support plate, a housing, and an actuator assembly.

[0545] Example 97: A delivery system according to any example herein, particularly Example 96, wherein the sliding engagement of the housing with the proximal portion of the outer sheath allows the outer sheath to slide relative to the handle.

[0546] Example 98: A delivery system according to any example herein, particularly Example 96 or Example 97, wherein the actuator assembly includes a control knob positioned on the handle, and the proximal portion of the pulling tether is coupled to an adapter engaged by the control knob.

[0547] Example 99: A delivery system according to any example herein, particularly Examples 86 to 98, wherein the sliding engagement of the housing with the proximal portion of the outer sheath allows the outer sheath to slide relative to the support plate.

[0548] Example 100: A delivery system according to any example herein, particularly Examples 86 to 99, further comprising an implant, wherein the implant is a prosthetic mitral valve or a prosthetic tricuspid valve.

[0549] Example 101: A method includes: delivering an implant to an autologous heart valve using a delivery system, wherein the delivery system includes: a delivery catheter for advancing the implant to an implantation site, the delivery catheter including: a slender shaft adapted to deflect in one or more planes, the slender shaft having: an outer sheath having a distal portion, a proximal portion, and a length; a pull tether having a distal portion and a proximal portion and extending along the length of the outer sheath, the distal portion being coupled to the outer sheath; a compression coil surrounding at least a portion of the pull tether and including a distal portion and a proximal portion, the compression coil not being directly connected to the outer sheath and being slidable relative to the pull tether; and a tube surrounding at least a portion of the pull tether and including a distal portion and a proximal portion, the tube not being directly connected to the outer sheath and being slidable relative to the pull tether, the distal portion of the tube being adapted to dock with the proximal portion of the compression coil; a support plate including an opening for the pull tether to pass through, the support plate being adapted to dock with the proximal portion of the tube; a housing slidably engaged with the proximal portion of the outer sheath; and an actuator assembly for applying tension to the pull tether to deflect the slender shaft, whereby the force applied to the compression coil is transmitted through the tube to the support plate.

[0550] Example 102: The method according to any example herein, particularly Example 101, wherein the slender shaft is a guide rail shaft, and the delivery catheter includes one or more shafts adapted to slide relative to the guide rail shaft.

[0551] Example 103: The method according to any example herein, particularly Example 102, wherein the one or more shafts are adapted to slide relative to the guide rail shaft to change the depth of the one or more shafts relative to the guide rail shaft.

[0552] Example 104: The method according to any example herein, particularly Example 102 or Example 103, wherein the outer sheath includes a bent portion configured to form a bend when the actuator assembly applies the tension to the pull tether.

[0553] Example 105: The method according to any example herein, particularly Example 104, wherein the one or more shafts are adapted to slide relative to the bend to change the depth of the one or more shafts relative to the guide rail shaft.

[0554] Example 106: A delivery system for an implant, the delivery system comprising: a delivery catheter for advancing the implant to an implantation site, the delivery catheter comprising: a elongate shaft adapted to deflect in one or more planes, the elongate shaft having: an outer sheath having a distal portion and a proximal portion and a length; a pull tether having a distal portion and a proximal portion and extending along the length of the outer sheath, the distal portion being coupled to the outer sheath; a lumen surrounding at least a portion of the pull tether and having a distal portion and a proximal portion, the lumen not being directly connected to the outer sheath and being slidable relative to the pull tether; and an actuator assembly for applying tension to the pull tether to deflect the elongate shaft and, simultaneously, applying a distal compressive force to the lumen.

[0555] Example 107: The delivery system according to any one of the examples herein, particularly Example 106, wherein the actuator assembly includes a control knob.

[0556] Example 108: The delivery system according to any one of the examples herein, particularly Example 107, further comprising a handle coupled to the proximal portion of the elongate shaft, the control knob being positioned on the handle.

[0557] Example 109: The delivery system according to any one of the examples herein, particularly Example 108, wherein the control knob is not threadably engageable with the outer surface of the handle.

[0558] Example 110: The delivery system according to any one of the examples herein, particularly Examples 107 to 109, further comprising a pull tether adapter coupled to the proximal portion of the pull tether and a lumen adapter coupled to the proximal portion of the lumen, and wherein the control knob engages the pull tether adapter and the lumen adapter.

[0559] Example 111: The delivery system according to any one of the examples herein, particularly Example 110, wherein the control knob is adapted to longitudinally drive the pull tether adapter and the lumen adapter in opposite directions when the control knob is rotated in a single direction.

[0560] Example 112: The delivery system according to any one of the examples herein, particularly Example 110 or Example 111, wherein the control knob has a fixed rotational coupling with one of the pull wire adapter or the lumen adapter and a threaded coupling with the other of the pull wire adapter or the lumen adapter.

[0561] Example 113: A delivery system according to any one of the examples herein, particularly examples 106 to 112, wherein the actuator assembly is adapted to simultaneously apply a tension that is equal and opposite to the distal compression force.

[0562] Example 114: A delivery system according to any one of the examples herein, particularly examples 106 to 113, wherein the pull tether is a first pull tether, and the lumen is a first lumen, and the actuator assembly is a first actuator assembly, and the tension on the first pull tether deflects the elongate shaft in a first plane, and the delivery system further comprises: a second pull tether having a distal portion and a proximal portion and extending along the length of the outer sheath, the distal portion of the second pull tether being coupled to the outer sheath; a second lumen surrounding at least a portion of the second pull tether and including a distal portion and a proximal portion, the second lumen not being directly connected to the outer sheath and being slidable relative to the second pull tether; and a second actuator assembly for applying a tension to the second pull tether to deflect the elongate shaft in a second plane transverse to the first plane and simultaneously applying a distal compression force to the second lumen.

[0563] Example 115: A delivery system according to any one of the examples herein, particularly examples 106 to 114, further comprising a compression coil surrounding at least a portion of the pull tether and including a distal portion and a proximal portion, the compression coil not being directly connected to the outer sheath and being slidable relative to the pull tether.

[0564] Example 116: A delivery system according to any one of the examples herein, particularly examples 106 to 115, wherein the elongate shaft is a guide rail shaft, and the delivery catheter comprises one or more shafts adapted to slide relative to the guide rail shaft.

[0565] Example 117: A delivery system according to any one of the examples herein, particularly example 116, wherein the one or more shafts are adapted to slide relative to the guide rail shaft to change the depth of the one or more shafts relative to the guide rail shaft.

[0566] Example 118: A delivery system according to any one of the examples herein, particularly example 116 or example 117, wherein the outer sheath includes a curved portion configured to form a bend when the actuator assembly applies the tension to the pull tether.

[0567] Example 119: A delivery system according to any one of the examples herein, particularly example 118, wherein the one or more shafts are adapted to slide relative to the bend to change the depth of the one or more shafts relative to the guide rail shaft.

[0568] Example 120: The delivery system according to any one of the examples herein, particularly the delivery systems of Examples 106 to 119, further includes an implant, wherein the implant is a prosthetic mitral valve or a prosthetic tricuspid valve.

[0569] Example 121: A method includes: delivering an implant to an autologous heart valve using a delivery system, wherein the delivery system includes: a delivery catheter configured to advance the implant to an implantation site, the delivery catheter including: an elongate shaft adapted to deflect in one or more planes, the elongate shaft having: an outer sheath having a distal portion, a proximal portion, and a length; a pull tether having a distal portion and a proximal portion and extending along the length of the outer sheath, the distal portion being coupled to the outer sheath; a lumen surrounding at least a portion of the pull tether and including a distal portion and a proximal portion, the lumen not being directly connected to the outer sheath and being slidable relative to the pull tether; and an actuator assembly configured to apply tension to the pull tether to deflect the elongate shaft and simultaneously apply a distal compressive force to the lumen.

[0570] Example 122: The method according to any one of the examples herein, particularly Example 121, wherein the actuator assembly includes a control knob.

[0571] Example 123: The method according to any one of the examples herein, particularly Example 122, wherein the delivery catheter includes a handle coupled to the proximal portion of the elongate shaft, and the control knob is positioned on the handle.

[0572] Example 124: The method according to any one of the examples herein, particularly Example 123, wherein the control knob is not threadably engagable with the outer surface of the handle.

[0573] Example 125: The method according to any one of the examples herein, particularly Examples 122 to 124, wherein a pull tether adapter is coupled to the proximal portion of the pull tether and a lumen adapter is coupled to the proximal portion of the lumen, and wherein the control knob engages the pull tether adapter and the lumen adapter.

[0574] Example 126: A delivery system for an implant, the delivery system comprising: an elongate shaft for advancing the implant to an implantation site and including a proximal portion and a distal portion, the elongate shaft being adapted to deflect in a first plane about a curved portion of the elongate shaft; a control mechanism adapted to control the deflection of the elongate shaft, the control mechanism including: a deflection actuator adapted to cause the elongate shaft to deflect in the first plane about the curved portion; a traction tether assembly including a traction tether and an adapter, the traction tether including a proximal portion coupled to the distal portion of the elongate shaft and a proximal portion coupled to the adapter; and a knob assembly adapted to rotate in a first direction to create a depth of the distal portion of the elongate shaft relative to the curved portion, and to rotate in a second direction to retract the adapter to deflect the elongate shaft to create a height of the elongate shaft in a direction opposite to the depth.

[0575] Example 127: The delivery system according to any one of the examples herein, particularly Example 126, wherein the elongate shaft includes a guide rail shaft and one or more shafts adapted to slide relative to the guide rail shaft, and the knob assembly is adapted to rotate in the first direction to cause the one or more shafts to slide distally relative to the guide rail shaft to create the depth of the distal portion.

[0576] Example 128: The delivery system according to any one of the examples herein, particularly Example 127, wherein the knob assembly is adapted to rotate in the second direction to cause the one or more shafts to slide proximally relative to the guide rail shaft to reduce the depth of the distal portion.

[0577] Example 129: The delivery system according to any one of the examples herein, particularly Examples 126 to 128, wherein the traction tether assembly is a first traction tether assembly, and the delivery system further includes a second traction tether assembly including a traction tether and an adapter, the deflection actuator being adapted to actuate the second traction tether assembly to cause the elongate shaft to deflect in the first plane about the curved portion.

[0578] Example 130: The delivery system according to any one of the examples herein, particularly Example 129, wherein the deflection actuator is a first deflection actuator, and the delivery system further includes a second deflection actuator and a third traction tether assembly including a traction tether and an adapter, the second deflection actuator being adapted to actuate the third traction tether assembly to cause the elongate shaft to deflect in a second plane about the curved portion, the second plane being transverse to the first plane.

[0579] Example 131: A delivery system according to any example herein, particularly example 130, wherein the second plane is perpendicular to the first plane.

[0580] Example 132: A delivery system according to any example herein, particularly examples 126 to 131, further comprising a handle coupled to the proximal portion of the elongate shaft, the knob assembly being positioned on the handle.

[0581] Example 133: A delivery system according to any example herein, particularly example 132, wherein the adapter of the pull tether assembly includes threads, and the knob assembly includes threads for engaging the threads of the adapter.

[0582] Example 134: A delivery system according to any example herein, particularly example 133, wherein the handle includes an internal cavity, and the adapter is positioned within the internal cavity of the handle, and the threads of the knob assembly are configured to retract the adapter within the internal cavity to create the height, and to advance the adapter within the internal cavity to reduce the height.

[0583] Example 135: A delivery system according to any example herein, particularly example 133 or example 134, wherein the elongate shaft includes a guide rail shaft and one or more shafts adapted to slide relative to the guide rail shaft, and wherein the handle includes a first housing coupled to the guide rail shaft and a second housing coupled to the one or more shafts adapted to slide relative to the guide rail shaft, the first housing being adapted to slide relative to the second housing, and the knob assembly being adapted to cause the first housing to slide relative to the second housing to create the depth.

[0584] Example 136: A delivery system according to any example herein, particularly example 135, wherein the second housing includes threads, and the knob assembly is axially fixed relative to the first housing and includes threads, the threads of the knob assembly for engaging the threads of the second housing to cause the first housing to slide relative to the second housing to create the depth.

[0585] Example 137: A delivery system according to any example herein, particularly example 136, wherein the knob assembly includes threads, the threads of the knob assembly for engaging the threads of the second housing and for engaging the threads of the adapter of the pull tether assembly.

[0586] Example 138: A delivery system according to any example herein, particularly example 137, wherein the knob assembly is adapted to alternately engage the threads of the second housing and the threads of the adapter to cause the adapter to slide relative to the second housing.

[0587] Example 139: A delivery system according to any example herein, particularly Example 138, wherein the threads of the knob assembly are disengaged from the threads of the second housing to allow the adapter to slide relative to the second housing.

[0588] Example 140: A delivery system according to any example herein, particularly Examples 126 to 139, wherein the knob assembly includes a first portion and a second portion, the second portion being engaged with the first portion such that the first portion rotates with the second portion, and the second portion being adapted to be released from the first portion to allow the second portion to rotate relative to the second portion.

[0589] Example 141: A delivery system according to any example herein, particularly Example 140, wherein a latch mechanism engages the first portion with the second portion.

[0590] Example 142: A delivery system according to any example herein, particularly Example 141, wherein the latch mechanism is adapted to be overcome with a torsional force or a longitudinal force.

[0591] Example 143: A delivery system according to any example herein, particularly Examples 140 to 142, further comprising a handle coupled to the proximal portion of the elongate shaft, the knob assembly being positioned on the handle, and wherein the second portion is adapted to slide the adapter of the pull tether assembly relative to the handle to create the height.

[0592] Example 144: A delivery system according to any example herein, particularly Examples 126 to 143, wherein the elongate shaft includes a sac for extending over the implant.

[0593] Example 145: A delivery system according to any example herein, particularly Examples 126 to 144, further comprising an implant, wherein the implant is a prosthetic mitral valve or a prosthetic tricuspid valve.

[0594] Example 146: A method includes: delivering an implant to an autologous heart valve using a delivery system, wherein the delivery system includes: an elongate shaft for advancing the implant to an implantation site and including a proximal portion and a distal portion, the elongate shaft being adapted to deflect in a first plane about a curved portion of the elongate shaft; a control mechanism adapted to control the deflection of the elongate shaft, the control mechanism including: a deflection actuator adapted to cause the elongate shaft to deflect about the curved portion in the first plane; a pull tether assembly including a pull tether and an adapter, the pull tether including a proximal portion coupled to the distal portion of the elongate shaft and a proximal portion coupled to the adapter; and a knob assembly adapted to rotate in a first direction to create a depth of the distal portion of the elongate shaft relative to the curved portion and to rotate in a second direction to retract the adapter to deflect the elongate shaft to create a height of the elongate shaft in a direction opposite to the depth.

[0595] Example 147: The method according to any example herein, particularly Example 146, wherein the elongate shaft includes a guide rail shaft and one or more shafts adapted to slide relative to the guide rail shaft, and the knob assembly is adapted to rotate in the first direction to cause the one or more shafts to slide distally relative to the guide rail shaft to create the depth of the distal portion.

[0596] Example 148: The method according to any example herein, particularly Example 147, wherein the knob assembly is adapted to rotate in the second direction to cause the one or more shafts to slide proximally relative to the guide rail shaft to reduce the depth of the distal portion.

[0597] Example 149: The method according to any example herein, particularly Examples 146 to 148, wherein the pull tether assembly is a first pull tether assembly, and the delivery system further includes a second pull tether assembly including a pull tether and an adapter, the deflection actuator being adapted to actuate the second pull tether assembly to cause the elongate shaft to deflect about the curved portion in the first plane.

[0598] Example 150: The method according to any example herein, particularly Example 149, wherein the deflection actuator is a first deflection actuator, and the delivery system further includes a second deflection actuator and a third pull tether assembly including a pull tether and an adapter, the second deflection actuator being adapted to actuate the third pull tether assembly to cause the elongate shaft to deflect about the curved portion in a second plane transverse to the first plane.

[0599] Example 151: A delivery system for an implant, the delivery system comprising: a delivery catheter for advancing the implant to an implantation site, the delivery catheter comprising: a guide wire sheath having a proximal portion and a distal end and an internal lumen for passing a guide wire therethrough, the internal lumen having a diameter; and a spacer body positioned at the distal end of the guide wire sheath and projecting distally from the distal end, the spacer body comprising an opening through which the guide wire projects and a cavity having a diameter greater than the diameter of the internal lumen and adapted for the guide wire to deflect therein.

[0600] Example 152: The delivery system according to any one of the examples herein, particularly Example 151, wherein the spacer body comprises an orifice for the guide wire to enter the cavity.

[0601] Example 153: The delivery system according to any one of the examples herein, particularly Example 152, wherein the opening is positioned distally of the orifice.

[0602] Example 154: The delivery system according to any one of the examples herein, particularly Examples 151 to 153, wherein the cavity has a dome shape.

[0603] Example 155: The delivery system according to any one of the examples herein, particularly Examples 151 to 154, wherein the spacer body comprises a ridge extending radially inwards towards the cavity.

[0604] Example 156: The delivery system according to any one of the examples herein, particularly Examples 151 to 155, wherein the spacer body has a dome shape.

[0605] Example 157: The delivery system according to any one of the examples herein, particularly Examples 151 to 156, wherein the spacer body has a conical shape.

[0606] Example 158: The delivery system according to any one of the examples herein, particularly Examples 15I to 157, wherein the spacer body comprises a plurality of openings through which the guide wire projects.

[0607] Example 159: The delivery system according to any one of the examples herein, particularly Example 158, wherein the spacer body comprises at least one rib separating the plurality of openings.

[0608] Example 160: The delivery system according to any one of the examples herein, particularly Examples 151 to 159, wherein the opening is positioned at the distal end of the spacer body.

[0609] Example 161: A delivery system according to any example herein, particularly examples 151 to 160, wherein the spacer body includes one or more sidewalls extending distally to a distal end of the spacer body, and the opening is positioned in the one or more sidewalls.

[0610] Example 162: A delivery system according to any example herein, particularly examples 151 to 161, wherein the spacer body is a nose body of the delivery catheter.

[0611] Example 163: A delivery system according to any example herein, particularly examples 151 to 162, wherein the inner lumen is adapted for distal advancement or proximal retraction of a guide wire.

[0612] Example 164: A delivery system according to any example herein, particularly examples 151 to 163, further comprising a sac for holding an implant.

[0613] Example 165: A delivery system according to any example herein, particularly examples 151 to 164, further comprising an implant, wherein the implant is a prosthetic mitral valve or a prosthetic tricuspid valve.

[0614] Example 166: A method comprising: delivering an implant to an autologous heart valve using a delivery system, wherein the delivery system includes: a delivery catheter for advancing the implant to an implantation site, the delivery catheter including: a guide wire sheath having a proximal portion, a distal end, and an inner lumen for passing a guide wire therethrough, the inner lumen having a diameter; and a spacer body positioned at the distal end of the guide wire sheath and protruding distally from the distal end, the spacer body including an opening through which the guide wire protrudes and a cavity having a diameter greater than the diameter of the inner lumen and adapted for deflection of the guide wire therein.

[0615] Example 167: The method according to any example herein, particularly example 166, wherein the spacer body includes an orifice for the guide wire to enter the cavity.

[0616] Example 168: The method according to any example herein, particularly example 167, wherein the opening is positioned distally of the orifice.

[0617] Example 169: The method according to any example herein, particularly examples 166 to 168, wherein the cavity has a dome shape.

[0618] Example 170: The method according to any example herein, particularly examples 166 to 169, wherein the spacer body includes a ridge extending radially inwardly towards the cavity.

[0619] Any feature of any instance, including but not limited to any of the first through 170 instances mentioned above, applies to all other aspects and instances identified herein, including but not limited to any of the first through 170 instances mentioned above. In addition, features of individual instances, including but not limited to any of the features of any of the first through 170 instances mentioned above, may be combined, in whole or in part, with other instances described herein in any manner, e.g., one, two, or three or more instances may be combined in whole or in part. In addition, features of individual instances, including but not limited to any of the features of any of the first through 170 instances mentioned above, may be made optional for other instances. Any instance of a method may be performed by the system or device of another instance, and any aspect or instance of a system or device may be configured to perform another aspect or instance, including but not limited to the method of any of the first through 170 instances mentioned above.

[0620] Finally, it should be understood that although aspects of this specification have been highlighted by reference to specific instances, those skilled in the art will readily appreciate that these disclosed instances are merely illustrative of the principles of the subject matter disclosed herein. Accordingly, it should be understood that the subject matter disclosed is in no way limited to the specific methods, schemes, and / or reagents, etc. described herein. Thus, various modifications, variations, or alternative configurations of the subject matter disclosed may be made in accordance with the teachings herein without departing from the spirit of this specification. Finally, the terms used herein are for the purpose of describing particular examples only and are not intended to limit the scope of the systems, devices, and methods disclosed herein, which scope is defined only by the claims. Accordingly, the systems, devices, and methods are not limited to the exact details shown and described.

[0621] Certain instances of systems, devices, and methods are described herein, including the best mode known to the inventors for carrying out these instances. Of course, variations of these described instances will become apparent to those of ordinary skill in the art after reading the foregoing description. The inventors expect skilled artisans to employ such variations appropriately, and the inventors intend for the systems, devices, and methods to be practiced otherwise than as specifically described herein. Accordingly, the systems, devices, and methods include all modifications and equivalents of the subject matter recited in the appended claims as permitted by applicable law. In addition, unless otherwise stated herein or clearly contradicted by context, the systems, devices, and methods cover any combination of the above instances in all possible variations thereof.

[0622] Groupings of alternative examples, elements, or steps of the systems, devices, and methods described herein should not be construed as limiting. Each member of a group can be referred to and claimed individually or in any combination with other members disclosed herein. For purposes of convenience and / or patentability, it is anticipated that one or more members of a group can be included in or deleted from the group. When any such inclusion or deletion is made, the specification is to be regarded as including the modified group in order to satisfy the written description of all Markush groups used in the appended claims.

[0623] Unless otherwise indicated, all numbers expressing features, items, quantities, parameters, properties, terms, etc., used in this specification and the claims are to be understood as being modified in all instances by the term "about." As used herein, the term "about" means that the feature, item, quantity, parameter, property, or term so qualified covers approximations that can vary but which are capable of performing the desired operation or process discussed herein.

[0624] Unless otherwise specified herein or clearly contradicted by context, the terms "a," "an," "the," and similar referents used in the context of describing the systems, devices, and methods (especially in the context of the following claims) are to be construed to cover both the singular and the plural. Unless otherwise specified herein or otherwise clearly contradicted by context, all methods described herein can be performed in any suitable order. The use of any and all examples or exemplary language (e.g., "such as") provided herein is merely intended to better illustrate the systems, devices, and methods and does not pose a limitation on the scope of the systems, devices, and methods claimed. Any language in this specification should not be construed as indicating any unclaimed element essential to the practice of the systems, devices, and methods.

[0625] All patents, patent publications, and other publications cited and identified in this specification are hereby incorporated by reference in their entirety, individually and expressly, for the purpose of describing and disclosing, for example, the compositions and methods described in such publications that may be used in connection with the systems, devices, and methods. These publications are provided solely for their disclosure prior to the filing date of this application. Nothing in this regard should be construed as an admission that the inventors are entitled to antedate such disclosure by virtue of prior invention or for any other reason. All statements as to the date or content of these documents are based on the information available to the applicant and do not constitute an admission as to the correctness of the date or content of these documents.

Claims

1. A system for replacing the function of an autologous atrioventricular valve, the system comprising: A prosthetic heart valve including a self-expanding frame and a plurality of leaflets disposed within the lumen of the frame to permit unidirectional blood flow; A delivery catheter having an elongate shaft for advancing the prosthetic heart valve through a patient's vasculature to the autologous atrioventricular valve, the elongate shaft including a balloon along a distal portion of the elongate shaft for maintaining the prosthetic heart valve in a compressed state; A tether assembly extending through the elongate shaft of the delivery catheter, the tether assembly including a plurality of coupling tethers disposed along a distal portion of the tether assembly, the coupling tethers being sized to extend through an opening in the prosthetic heart valve; And A release assembly including one or more flexible release tethers configured to extend through a loop portion of the coupling tethers to secure the prosthetic heart valve to the tether assembly, wherein the one or more release tethers are retractable for removal from the one or more loop portions and thereby permit release of the tether assembly from the prosthetic heart valve; Wherein the prosthetic heart valve is capable of popping out of the balloon and is permitted to expand and operate while still attached to the tether assembly, and wherein the prosthetic heart valve is capable of being released from the tether assembly after confirmation of proper deployment and operation within the autologous atrioventricular valve.

2. The system according to claim 1, wherein the tether assembly further comprises: A tether manifold attached to the plurality of coupling tethers; And A flexible retention tether coupled to the tether manifold and extending proximally from the tether manifold for engagement with a tether actuator.

3. The system according to claim 2, wherein the tether manifold includes a wire forming a loop, and the plurality of coupling tethers loop around the loop of the tether manifold.

4. The system according to claim 3, wherein the plurality of coupling tethers includes a continuous suture that loops around the loop of the tether manifold multiple times to form each of the plurality of coupling tethers.

5. The system according to any one of claims 2 to 4, wherein the flexible retention tether is woven or braided.

6. The system according to any one of claims 1 to 5, wherein each of the release tethers extends through at least three of the loop portions for securing the loop portions to the prosthetic heart valve.

7. The system according to any one of claims 1 to 6, wherein the release assembly includes at least three of the release tethers.

8. The system according to any one of claims 1 to 6, wherein the release assembly includes only one of the release tethers.

9. The system according to any one of claims 1 to 8, wherein the release assembly further comprises: A release tether manifold from which a plurality of the release tethers branch; And A retractable tether coupled to and extending proximally from the release tether manifold for engaging a release actuator.

10. The system according to any one of claims 1 to 9, wherein the sac is retractable for ejecting the prosthetic heart valve from the sac.

11. The system according to any one of claims 1 to 10, wherein the elongate shaft comprises a plurality of shafts, at least one of the plurality of shafts comprising a guide rail shaft adapted to form a curved portion for curving the other shafts of the elongate shaft.

12. The system according to claim 11, wherein the guide rail shaft is adapted to curve in a first direction in a first plane and in a second direction in a second plane, the second plane extending transversely to the first plane.

13. The system according to claim 12, wherein the guide rail shaft is adapted to slide relative to the sac to change the depth of the sac relative to the curved portion, and the guide rail shaft is adapted to curve in a third direction in the first plane, the third direction being opposite to the first direction to change the height of the sac.

14. The system according to claim 13, wherein the delivery catheter comprises a handle positioned at a proximal portion of the elongate shaft, the handle comprising a knob assembly for actuating a pull tether that curves the guide rail shaft in the third direction to change the height of the sac.

15. The system according to any one of claims 12 to 14, wherein the delivery catheter comprises a handle positioned at a proximal portion of the elongate shaft, the handle comprising a deflection actuator adapted to deflect the elongate shaft in the first direction in the first plane.

16. The system according to any one of claims 1 to 15, wherein the delivery catheter comprises a handle positioned at a proximal portion of the elongate shaft, the handle comprising a tether actuator for advancing or retracting the tether assembly along the elongate shaft.

17. The system according to claim 16, wherein the tether actuator is adapted to advance the tether assembly from a distal pusher of the elongate shaft to expand the prosthetic heart valve.

18. The system according to claim 17, wherein the distal pusher compresses an inlet end portion of the prosthetic heart valve.

19. The system according to claim 17 or claim 18, wherein the tether actuator is adapted to retract the tether assembly to retract the prosthetic heart valve into the distal pusher.

20. The system according to any one of claims 1 to 19, wherein the delivery catheter comprises a handle positioned at a proximal portion of the elongate shaft, the handle comprising a release actuator operable to retract the release assembly to retract the one or more release tethers from the one or more loop portions.

21. The system according to any one of claims 1 to 20, wherein the delivery catheter includes a handle positioned at a proximal portion of the elongate shaft, and wherein the system further includes a stabilizer configured to be coupled to the handle for stabilizing the delivery catheter during deployment of the prosthetic heart valve to the native atrioventricular valve.

22. The system according to any one of claims 1 to 21, wherein the prosthetic heart valve includes at least nine of the openings.

23. The system according to any one of claims 1 to 22, wherein the openings are positioned at an inlet end portion of the prosthetic heart valve.

24. The system according to any one of claims 1 to 23, wherein the openings are fenestrations.

25. The system according to any one of claims 1 to 24, wherein the native atrioventricular valve is a native tricuspid valve.

26. A system for replacing the function of a native atrioventricular valve, the system comprising: A prosthetic heart valve including a self-expanding frame and a plurality of leaflets disposed within the lumen of the frame to permit unidirectional flow; A delivery catheter including: An elongate shaft for advancing the prosthetic heart valve to the native atrioventricular valve, the elongate shaft including a proximal portion and a distal portion, the elongate shaft being adapted to deflect in a first plane about a curved portion of the elongate shaft; A control mechanism adapted to control deflection of the elongate shaft, the control mechanism including: A deflection actuator adapted to deflect the elongate shaft about the curved portion in the first plane, A pull tether assembly including a pull tether and an adapter, the pull tether including a proximal portion coupled to the distal portion of the elongate shaft and a proximal portion coupled to the adapter, and A knob assembly adapted to rotate in a first direction to create a depth of the distal portion of the elongate shaft relative to the curved portion, and rotate in a second direction to retract the adapter to deflect the elongate shaft to create a height of the elongate shaft in a direction opposite the depth.

27. The system according to claim 26, wherein the elongate shaft includes a guide rail shaft and one or more shafts adapted to slide relative to the guide rail shaft, and the knob assembly is adapted to rotate in the first direction to slide the one or more shafts distally relative to the guide rail shaft to create the depth of the distal portion.

28. The system according to claim 27, wherein the knob assembly is adapted to rotate in the second direction to slide the one or more shafts proximally relative to the guide rail shaft to reduce the depth of the distal portion.

29. The system according to any one of claims 26 to 28, wherein the traction tether assembly is a first traction tether assembly, and the system further comprises a second traction tether assembly, the second traction tether assembly comprising a traction tether and an adapter, and the deflection actuator being adapted to actuate the second traction tether assembly to deflect the elongate shaft about the curved portion in the first plane.

30. The system according to claim 29, wherein the deflection actuator is a first deflection actuator, and the system further comprises a second deflection actuator and a third traction tether assembly, the third traction tether assembly comprising a traction tether and an adapter, the second deflection actuator being adapted to actuate the third traction tether assembly to deflect the elongate shaft about the curved portion in a second plane, the second plane being transverse to the first plane.

31. The system according to claim 30, wherein the second plane is perpendicular to the first plane.

32. The system according to any one of claims 26 to 31, further comprising a handle coupled to the proximal portion of the elongate shaft, the knob assembly being positioned on the handle.

33. The system according to claim 32, wherein the adapter of the traction tether assembly comprises threads, and the knob assembly comprises threads for engaging the threads of the adapter.

34. The system according to claim 33, wherein the handle comprises an internal cavity, and the adapter is positioned within the internal cavity of the handle, and the threads of the knob assembly are configured to retract the adapter within the internal cavity to create the height, and to advance the adapter within the internal cavity to reduce the height.

35. The system according to claim 33 or claim 34, wherein the elongate shaft comprises a guide rail shaft and one or more shafts adapted to slide relative to the guide rail shaft, and wherein the handle comprises a first housing coupled to the guide rail shaft and a second housing coupled to the one or more shafts adapted to slide relative to the guide rail shaft, the first housing being adapted to slide relative to the second housing, and the knob assembly being adapted to slide the first housing relative to the second housing to create the depth.

36. The system according to claim 35, wherein the second housing comprises threads, and the knob assembly is axially fixed relative to the first housing and comprises threads, the threads of the knob assembly being for engaging the threads of the second housing to slide the first housing relative to the second housing to create the depth.

37. The system according to claim 36, wherein the knob assembly comprises threads for engaging the threads of the second housing and for engaging the threads of the adapter of the traction tether assembly.

38. The system according to claim 37, wherein the knob assembly is adapted to alternately engage the threads of the second housing and the threads of the adapter to slide the adapter relative to the second housing.

39. The system according to claim 38, wherein the threads of the knob assembly disengage from the threads of the second housing to allow the adapter to slide relative to the second housing.

40. The system according to any one of claims 26 to 39, wherein the knob assembly includes a first portion and a second portion, the second portion being engaged with the first portion such that the first portion rotates with the second portion, and the second portion being adapted to be released from the first portion to allow the second portion to rotate relative to the second portion.

41. The system according to claim 40, wherein a latch mechanism engages the first portion with the second portion.

42. The system according to claim 41, wherein the latch mechanism is adapted to be overcome with a torsional force or a longitudinal force.

43. The system according to any one of claims 40 to 42, further comprising a handle coupled to the proximal portion of the elongate shaft, the knob assembly being positioned on the handle, and wherein the second portion is adapted to slide the adapter of the retraction tether assembly relative to the handle to create the height.

44. The system according to any one of claims 26 to 43, further comprising: one or more coupling tethers, each coupling tether including a first portion and a second portion, the first portion being configured to be coupled to the prosthetic heart valve to hold the prosthetic heart valve to the elongate shaft; and a disassembly assembly, the disassembly assembly being configured to be connected to the second portion of the one or more coupling tethers and to disassemble the connection with the second portion to release the prosthetic heart valve from the elongate shaft.

45. The system according to any one of claims 26 to 44, wherein the native atrioventricular valve is a native tricuspid valve.

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