Delivery system and tether assembly for a prosthetic valve

Abstract

A system for replacing the function of a native atrioventricular valve includes a prosthetic heart valve and a steerable delivery catheter. A capsule or sheath is provided along a distal end portion of the delivery catheter to maintain the prosthetic heart valve in a compressed state during advancement through the vascular system. A tether assembly includes an attachment tether adapted to extend through the delivery catheter and pass through an opening in the prosthetic heart valve. A release assembly includes a release tether for securing the attachment tether to the prosthetic heart valve. The release tether is retractable to detach the attachment tether from the prosthetic heart valve. The prosthetic heart valve can be released from the capsule and, while attached to the tether assembly, can expand and operate as a one-way valve. The prosthetic heart valve can then be detached from the tether assembly after confirming proper deployment.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of 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 incorporated herein by reference.

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

[0003] 2. Description of Related Art Human heart valves, including the aortic, pulmonary, mitral, and tricuspid valves, essentially function as one-way valves that operate in sync with the heartbeat. The valves allow downstream blood flow but prevent upstream blood flow. Affected heart valves exhibit conditions such as valve stenosis or regurgitation, which impair the valve's ability to control blood flow. Such conditions reduce the heart's blood-pumping efficiency and can be debilitating and critical. For example, valve dysfunction can lead to symptoms such as cardiac hypertrophy and ventricular dilation. Therefore, considerable efforts have been made to develop methods and devices for repairing or replacing dysfunctional heart valves.

[0004] Prostheses exist to correct problems associated with dysfunctional heart valves. For example, mechanical, tissue-based prosthetic heart valves can be used to replace dysfunctional native heart valves. Recently, significant efforts have been made to develop replacement heart valves, particularly tissue-based replacement heart valves, which can be delivered less traumatically to patients compared to open-heart surgery. Replacement valves are designed to be delivered by minimally invasive, and even percutaneous, procedures. Such replacement valves often include prosthetic valve leaflets connected to an expandable frame, which is then delivered to the annulus of the native valve.

[0005] The development of prosthetic valves, including but not limited to replacement heart valves, that can be miniaturized for delivery and then controllably expanded for controlled deployment has proven particularly challenging. An additional challenge relates to the ability to secure such prostheses to endoluminal tissue, such as tissue within any body lumen or cavity, in an atraumatic manner.

[0006] Delivering a prosthesis to a desired location within the human body, such as delivering a replacement heart valve to a mitral valve, can also be difficult. To achieve access to perform procedures within the heart or other anatomical locations, it may be necessary to deliver the device percutaneously through a tortuous vascular system or via an open or semi-open surgical procedure. The ability to control the deployment of the prosthesis at the desired location can also be difficult. Summary of the Invention

[0007]

[0003] Examples of the present disclosure may be directed to implants, which may comprise prosthetic devices, including, but not limited to, replacement heart valves. Further examples are directed to methods of use for delivering and / or controllably deploying implants, including, but not limited to, replacement heart valves, to desired locations within the body. In some examples, replacement heart valves and methods for delivering replacement heart valves to native heart valves, such as the mitral valve, aortic valve, or tricuspid valve, are provided.

[0008] The configuration of the delivery system and release mechanism for the implant may be disclosed herein.

[0009] An embodiment of the present disclosure may include a delivery system for an implant. The delivery system may include an elongate shaft including a proximal end portion and a distal end portion for advancing the implant to an implantation site, at least a portion of the elongate shaft comprising a tether assembly. The tether assembly may include a plurality of coupling tethers configured to couple 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] An embodiment of the present disclosure may include a method. The method may include delivering an implant to a native heart valve utilizing a delivery system. The delivery system may include an elongate shaft including a proximal end portion and a distal end portion for advancing the implant to the native heart valve, at least a portion of the elongate shaft comprising a tether assembly. The tether assembly may include a plurality of coupling tethers configured to couple 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] An embodiment of the present disclosure may include a delivery system for an implant. The delivery system may include an elongate shaft including a proximal end portion and a distal end portion for advancing the implant to an implantation site, at least a portion of the elongate shaft comprising a tether assembly and a release assembly. The tether assembly may include one or more attachment tethers configured to attach to the implant, each attachment tether including a loop portion configured to protrude from a respective 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 retain the implant in the one or more loop portions, the one or more release tethers configured to be retracted from the one or more loop portions to release the implant from the one or more loop portions.

[0012] An embodiment of the present disclosure may include a method. The method may include delivering an implant to a native heart valve using a delivery system. The delivery system may include an elongate shaft including a proximal end portion and a distal end portion for advancing the implant to the native heart valve. At least a portion of the elongate shaft may comprise a tether assembly and a release assembly. The tether assembly may include one or more attachment tethers configured to attach to the implant, each attachment tether including a loop portion configured to protrude from a respective 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 retain the implant in the one or more loop portions, the one or more release tethers configured to be retracted from the one or more loop portions to release the implant from the one or more loop portions.

[0013] An embodiment of the present disclosure may include a delivery system for an implant. The delivery system may include an elongate shaft including a proximal end portion and a distal end portion for advancing the implant to an implantation site. The delivery system may include one or more connecting tethers, each including a first portion and a second portion, the first portion configured to couple to the implant to retain the implant on the elongate shaft. The delivery system may include a disassembly assembly configured to connect to the second portion of the one or more connecting tethers and disassemble the connection to the second portion to release the implant from the elongate shaft.

[0014] An embodiment of the present disclosure may include a method for delivering an implant to a native heart valve using a delivery system. The delivery system may include an elongate shaft including a proximal end portion and a distal end portion for advancing the implant to the native heart valve, one or more attachment tethers each including a first portion and a second portion, the first portion configured to couple to the implant to retain the implant on the elongate shaft, and a disassembly assembly configured to connect to the second portion of the one or more attachment tethers and disassemble the connection to the second portion to release the implant from the elongate shaft.

[0015] An embodiment of the present disclosure may include a delivery system for an implant. The delivery system may include a delivery catheter including an elongate shaft adapted to be deflected in one or more planes to advance the implant to an implantation site. The elongate shaft may include an outer sheath having a distal end portion and a proximal end portion and a length; a pull tether having a distal end portion and a proximal end portion and extending along the length of the outer sheath, the distal end portion being coupled to the outer sheath; a compression coil surrounding at least a portion of the pull tether, the compression coil including a distal end portion and a proximal end portion, not directly connected to the outer sheath and slidable relative to the pull tether; and a tube surrounding at least a portion of the pull tether, the compression coil including a distal end portion and a proximal end portion, not directly connected to the outer sheath and slidable relative to the pull tether, the distal end portion of the tube adapted to abut against the proximal end portion of the compression coil. The delivery catheter may include a support plate including an opening through which the pull tether passes, the support plate adapted to abut against the proximal end portion of the tube. The delivery catheter can include a housing slidably engaged with the proximal end portion of the outer sheath. The delivery catheter can include an actuator assembly for applying tension to the pull tether to deflect the elongate shaft, whereby force exerted on the compression coil is transmitted through the tube to the support plate.

[0016] An embodiment of the present disclosure may include a method. The method may include delivering an implant to a native heart valve utilizing a delivery system. The delivery system may include a delivery catheter including an elongate shaft adapted to be deflected in one or more planes to advance the implant to an implantation site. The elongate shaft may include an outer sheath having distal and proximal end portions and a length; a pull tether having distal and proximal end portions and extending along the length of the outer sheath, the distal end portion being coupled to the outer sheath; a compression coil surrounding at least a portion of the pull tether, the compression coil including the distal and proximal end portions, not directly connected to the outer sheath and slidable relative to the pull tether; and a tube surrounding at least a portion of the pull tether, the tube including the distal and proximal end portions, not directly connected to the outer sheath and slidable relative to the pull tether, the distal end portion of the tube adapted to abut the proximal end 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 adapted to abut the proximal end portion of the tube. The delivery catheter may include a housing slidably engaged with the proximal end 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 force exerted on the compression coil is transmitted through the tube to the support plate.

[0017] An embodiment of the present disclosure may include a delivery system for an implant. The delivery system may include a delivery catheter including an elongate shaft adapted to be deflected in one or more planes to advance the implant to an implantation site. The elongate shaft may include an outer sheath having distal and proximal end portions and a length, a pull tether having distal and proximal end portions and extending along the length of the outer sheath, the pull tether being coupled to the outer sheath at the distal end portion, and a lumen surrounding at least a portion of the pull tether, the lumen including the distal and proximal end portions, the lumen not 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 and simultaneously applying a distal compressive force to the lumen to deflect the elongate shaft.

[0018] An embodiment of the present disclosure may include a method. The method may include delivering an implant to a native heart valve using a delivery system. The delivery system may include a delivery catheter including an elongate shaft adapted to be deflected in one or more planes to advance the implant to an implantation site. The elongate shaft may include an outer sheath having distal and proximal end portions and a length, a pull tether having distal and proximal end portions and extending along the length of the outer sheath, the pull tether being coupled to the outer sheath at the distal end portion, and a lumen surrounding at least a portion of the pull tether, the lumen including the distal and proximal end portions, the lumen not 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 and simultaneously applying a distal compressive force to the lumen to deflect the elongate shaft.

[0019] An embodiment of the present disclosure may include a delivery system for an implant. The delivery system may include an elongate shaft having a proximal end portion and a distal end portion for advancing the implant to an implantation site, the elongate shaft adapted to deflect in a first plane about a bent portion of the elongate shaft. The delivery system may include a control mechanism adapted to control deflection of the elongate shaft. The control mechanism may include a deflection actuator adapted to deflect the elongate shaft in the first plane about the bent portion, a pull tether assembly including a pull tether and an adapter, the pull tether including a distal end portion coupled to the elongate shaft and a proximal end portion coupled to the adapter, and a knob assembly adapted to be rotated in a first direction to create a depth relative to the bent portion of the distal end portion of the elongate shaft and to be rotated in a second direction to accommodate the adapter to deflect the elongate shaft to create a height of the elongate shaft in a direction opposite to the depth.

[0020] An embodiment of the present disclosure may include a method. The method may include delivering an implant to a native heart valve using a delivery system. The delivery system may include an elongate shaft having a proximal end portion and a distal end portion for advancing the implant to an implantation site, the elongate shaft adapted to deflect about a bent portion of the elongate shaft in a first plane. The delivery system may include a control mechanism adapted to control deflection of the elongate shaft. The control mechanism may include a deflection actuator adapted to deflect the elongate shaft in the first plane about the bent portion, a pull tether assembly including a pull tether and an adapter, the pull tether including a distal end portion coupled to the elongate shaft and a proximal end portion coupled to the adapter, and a knob assembly adapted to be rotated in a first direction to create a depth relative to the bent portion of the distal end portion of the elongate shaft and to be rotated in a second direction to accommodate the adapter to deflect the elongate shaft to create a height of the elongate shaft in a direction opposite to the depth.

[0021] An embodiment 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 end portion and a distal end and an internal lumen for passage of a guidewire therethrough, the internal lumen having a diameter, and a spacer body positioned at the distal end of the guidewire sheath and protruding distally from the distal end, the spacer body including an opening for the guidewire to protrude therethrough and a cavity having a diameter larger than the diameter of the internal lumen and adapted for deflection of the guidewire therein.

[0022] An embodiment of the present disclosure may include a method for delivering an implant to a native heart valve utilizing 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 end portion and a distal end and an internal lumen for passage of a guidewire therethrough, the internal lumen having a diameter, and a spacer body positioned at the distal end of the guidewire sheath and protruding distally from the distal end, the spacer body including an opening for the guidewire to protrude therethrough and a cavity having a diameter larger than the diameter of the internal lumen and adapted for deflection of the guidewire therethrough. [Brief explanation of the drawings]

[0023] [Figure 1] FIG. 1 shows a side view of a delivery system for an implant. [Figure 2] FIG. 2 shows a perspective view of the outer sheath subassembly of the delivery device of the delivery system of FIG. [Figure 3] FIG. 3 shows a side cross-sectional view of the capsule subassembly of the outer sheath subassembly of FIG. [Figure 4] FIG. 4 shows a perspective view of the capsule stent or distal hypotube of the outer sheath subassembly of FIG. [Figure 5]FIG. 5 illustrates, schematically, an embodiment in which the portion of the liner extending along the length of the outer sheath subassembly may have built-in slack to facilitate flexible bending of the outer sheath subassembly. [Figure 6] FIG. 6 shows a perspective view of the rail subassembly of the delivery device of the delivery system of FIG. [Figure 7] FIG. 7 shows a side cross-sectional view of the rail subassembly of FIG. [Figure 8] FIG. 8 illustrates, schematically, an embodiment in which the outer compression coil and pull wires can have a longer length than the inner compression coil and pull wires of the rail subassembly. [Figure 9] FIG. 9 illustrates, schematically, an embodiment in which the outer compression coil and pull wires can have a longer length than the inner compression coil and pull wires of the rail subassembly. [Figure 10] FIG. 10 shows a perspective view of the midshaft subassembly of the delivery device of the delivery system of FIG. [Figure 11] FIG. 11 shows a side cross-sectional view of the intermediate shaft subassembly of FIG. [Figure 12] FIG. 12 shows a side view of the tether assembly. [Figure 13] FIG. 13 shows a side view of the end portion of the tether assembly. [Figure 14] FIG. 14 shows a side view of a portion of the tether assembly. [Figure 15] FIG. 15 shows a side view of the tether assembly. [Figure 16] FIG. 16 shows a side view of the tether assembly. [Figure 17] FIG. 17 shows a perspective view of the end portion of the tether assembly. [Figure 18] FIG. 18 shows a perspective view of an implant coupled to a tether assembly. [Figure 19] FIG. 19 shows a side view of the release assembly. [Figure 20]FIG. 20 shows a perspective view of a release assembly extending through a loop portion of a tether assembly. [Figure 21] FIG. 21 shows a perspective view of the release assembly housed through the loop portion of the tether assembly. [Figure 22] FIG. 22 shows a perspective view of the release assembly housed through the loop portion of the tether assembly. [Figure 23] FIG. 23 shows a perspective view of the tether assembly released from the implant. [Figure 24] FIG. 24 shows a perspective view of the handle of the delivery system. [Figure 25] FIG. 25 shows a cross-sectional view of the handle shown in FIG. [Figure 26] FIG. 26 shows a schematic diagram of the delivery system approaching the implantation site. [Figure 27] FIG. 27 shows a schematic diagram of a delivery system approaching the tricuspid valve. [Figure 28] FIG. 28 shows a schematic diagram of the implant being deployed in the tricuspid valve. [Figure 29] FIG. 29 shows a schematic diagram of the implant being deployed in the tricuspid valve. [Figure 30] FIG. 30 shows a schematic diagram of the tether assembly released from the implant. [Figure 31] FIG. 31 shows a side view of the prosthetic valve deployed in a tricuspid valve. [Figure 32] FIG. 32 shows a partially exploded perspective view of the components of the disassembled assembly. [Figure 33] FIG. 33 shows a perspective view of an implant held by a pusher. [Figure 34] FIG. 34 shows a side view of the implant extended from the pusher shown in FIG. [Figure 35] FIG. 35 shows a side cross-sectional view of a delivery system including a disassembled assembly. [Figure 36] FIG. 36 shows a side cross-sectional view of the delivery system shown in FIG. 35 with the disassembly assembly activated. [Figure 37] FIG. 37 shows a side view of the exploded attachment tether extending to the implant. [Figure 38] FIG. 38 shows a side cross-sectional view of the components of the exploded assembly. [Figure 39] FIG. 39 shows a side cross-sectional view of the exploded assembly of FIG. 38 with the intermediate section disassembled. [Figure 40] FIG. 40 shows a side cross-sectional view of the components of the exploded assembly. [Figure 41] FIG. 41 shows a side cross-sectional view of the exploded assembly of FIG. 40 with the exploded assembly activated. [Figure 42] FIG. 42 shows a side view of multiple distally extended linking tethers. [Figure 43] FIG. 43 shows a partial cross-sectional view of the coupled tether shown in FIG. 42 forming a loop. [Figure 44] FIG. 44 shows a partial cross-sectional view of the coupled tether shown in FIG. 42 forming a loop. [Figure 45] FIG. 45 shows a perspective view of a woven or braided cylinder. [Figure 46] FIG. 46 shows a perspective view of a ring cut from the woven or braided cylinder shown in FIG. [Figure 47] FIG. 47 shows a side partial cross-sectional view of the ring shown in FIG. 46 coupled to a tether manifold. [Figure 48] Figure 48 shows a plan view of the fabric. [Figure 49] FIG. 49 shows a plan view of the fabric shown in FIG. 48 cut. [Figure 50] FIG. 50 shows a plan view of the fabric shown in FIG. 49 folded over on itself. [Figure 51] FIG. 51 shows a schematic side cross-sectional view of the woven pattern. [Figure 52] FIG. 52 shows a schematic side view of a length of a section of the woven pattern. [Figure 53] FIG. 53 shows a schematic side view of the braid assembly. [Figure 54]FIG. 54 shows a schematic side view of the braiding of the braid assembly. [Figure 55] FIG. 55 shows a side view of a braided tether assembly. [Figure 56A] FIG. 56A shows a perspective view of the release assembly. [Figure 56B] FIG. 56B shows a cross-sectional view of the release assembly shown in FIG. 56A. [Figure 57] FIG. 57 shows a cross-sectional view of the release assembly. [Figure 58] FIG. 58 shows a plan view of the tether assembly. [Figure 59] FIG. 59 shows a partial cross-sectional view of the tether assembly shown in FIG. [Figure 60A] FIG. 60A shows a perspective view of a tether manifold. [Figure 60B] FIG. 60B shows a partial cross-sectional view of a tether assembly utilizing the tether manifold shown in FIG. 60A. [Figure 61] FIG. 61 shows a cross-sectional view of the tether assembly taken along line II of FIG. 60B. [Figure 62] FIG. 62 shows a side view of the delivery system. [Figure 63] FIG. 63 shows a perspective view of the handle of the delivery system shown in FIG. [Figure 64] FIG. 64 shows a side view of the handle of the delivery system shown in FIG. [Figure 65] FIG. 65 shows a cross-sectional perspective view of the handle of the delivery system shown along the midline of FIG. [Figure 66] FIG. 66 shows a cross-sectional side view of the handle of the delivery system, shown along the midline of FIG. [Figure 67] FIG. 67 shows a perspective view of the rail shaft or elongated shaft of the delivery system. [Figure 68] FIG. 68 shows a perspective view of the rail shaft shown in FIG. 67 with the outer sheath removed from view. [Figure 69]FIG. 69 shows a perspective view of the distal insert of the rail shaft shown in FIG. [Figure 70] FIG. 70 shows a side perspective view of the intermediate insert of the rail shaft shown in FIG. [Figure 71] FIG. 71 shows a perspective view of the rail shaft with the outer sheath removed from view. [Figure 72] FIG. 72 shows a perspective view of the intermediate insert of the rail shaft shown in FIG. [Figure 73] FIG. 73 shows a perspective view of the rail shaft adapter. [Figure 74] FIG. 74 shows a perspective view of the rail shaft adapter with the outer sheath adapter removed from view. [Figure 75] FIG. 75 shows a cross-sectional view of the adapter shown in FIG. [Figure 76] FIG. 76 shows a perspective cross-sectional view of a handle utilizing an adapter as shown in FIG. [Figure 77] FIG. 77 shows a side cross-sectional view of the actuator assembly. [Figure 78] FIG. 78 shows a schematic diagram of the operation of one of the actuator assemblies shown in FIG. [Figure 79] FIG. 79 shows a schematic diagram of the operation of one of the actuator assemblies shown in FIG. [Figure 80] FIG. 80 shows a side view of the actuator assembly of FIG. 77 positioned on a handle. [Figure 81] FIG. 81 shows a side cross-sectional view of the knob assembly. [Figure 82] FIG. 82 shows a side partial cross-sectional view of the knob assembly shown in FIG. [Figure 83] FIG. 83 shows a perspective partial cross-sectional view of the knob assembly shown in FIG. [Figure 84] FIG. 84 shows a perspective cross-sectional view of the knob assembly shown in FIG. [Figure 85]85 shows a perspective partial cross-sectional view of the knob assembly shown in FIG. 81 from the opposite side of the handle shown in FIG. [Figure 86] FIG. 86 shows a side partial cross-sectional view of the handle and knob assembly. [Figure 87] FIG. 87 shows a schematic side view of a delivery system according to the configuration shown in FIG. [Figure 88] FIG. 88 shows a side partial cross-sectional view of the handle and knob assembly. [Figure 89] FIG. 89 shows a schematic side view of a delivery system according to the configuration shown in FIG. [Figure 90] FIG. 90 shows a side partial cross-sectional view of the handle and knob assembly. [Figure 91] FIG. 91 shows a schematic side view of a delivery system according to the configuration shown in FIG. [Figure 92] FIG. 92 shows a side partial cross-sectional view of the handle and knob assembly. [Figure 93] FIG. 93 shows a schematic side view of a delivery system according to the configuration shown in FIG. [Figure 94] FIG. 94 shows a side, partially see-through view of the handle and knob assembly. [Figure 95] FIG. 95 shows a side cross-sectional view of the handle and knob assembly shown in FIG. [Figure 96] FIG. 96 shows a perspective view of the alignment mechanism of the knob assembly shown in FIG. [Figure 97] FIG. 97 shows a side cross-sectional view of the handle and knob assembly shown in FIG. [Figure 98] FIG. 98 shows a side cross-sectional view of the handle and knob assembly shown in FIG. [Figure 99] FIG. 99 shows a perspective view of a pull tether adapter. [Figure 100] FIG. 100 shows a side cross-sectional view of a handle and knob assembly utilizing a pull tether adapter as shown in FIG. [Figure 101]FIG. 101 shows a side cross-sectional view of a handle and knob assembly utilizing a pull tether adapter as shown in FIG. [Figure 102] FIG. 102 shows a side cross-sectional view of a handle and knob assembly utilizing a pull tether adapter as shown in FIG. [Figure 103] FIG. 103 shows a side cross-sectional view of a handle and knob assembly utilizing a pull tether adapter as shown in FIG. [Figure 104] FIG. 104 shows a side cross-sectional view of a handle and knob assembly utilizing a pull tether adapter as shown in FIG. [Figure 105] FIG. 105 shows a perspective cross-sectional view of the proximal end portion of the handle of the delivery system shown in FIG. [Figure 106] FIG. 106 shows a side view of the nosecone. [Figure 107] FIG. 107 shows a side cross-sectional view of a guidewire being advanced through the nosecone shown in FIG. [Figure 108] FIG. 108 shows a side cross-sectional view of the guidewire sheath and spacer body. [Figure 109] FIG. 109 shows a side cross-sectional view of the guidewire sheath and spacer body of FIG. 108 with a guidewire advanced through the spacer body. [Figure 110] FIG. 110 shows a perspective view of the guidewire sheath and spacer body. [Figure 111] FIG. 111 shows a side cross-sectional view of the guidewire sheath and spacer body of FIG. 110 with a guidewire advanced through the spacer body. [Figure 112] FIG. 112 shows a side cross-sectional view of the guidewire sheath and spacer body. [Figure 113] FIG. 113 shows a side view of the guidewire sheath and spacer body. [Figure 114] FIG. 114 shows a side view of the guidewire sheath and spacer body. [Figure 115] FIG. 115 shows an end view of the spacer body. [Figure 116] FIG. 116 shows a side view of the guidewire sheath and spacer body. [Figure 117] FIG. 117 shows a side view of the guidewire sheath and spacer body. [Figure 118] FIG. 118 shows a transverse cross-section of the elongate shaft of the delivery catheter. [Figure 119] FIG. 119 shows a transverse cross-section of the elongate shaft of the delivery catheter. [Figure 120] FIG. 120 shows a perspective view of the ballast assembly. [Figure 121] FIG. 121 shows a perspective view of a prosthetic heart valve. [Figure 122] FIG. 122 shows a distal or outflow end view of the prosthetic heart valve shown in FIG. [Figure 123] FIG. 123 shows a schematic cross-sectional view of the prosthetic heart valve shown in FIG. DETAILED DESCRIPTION OF THE INVENTION

[0024] The present specification and drawings provide aspects and features of the present disclosure in the context of several examples of implants, such as prosthetic or replacement heart valves, and delivery systems and methods configured for use within a patient's vasculature, such as for replacing the patient's native heart valve. These examples may be described in connection with replacing a particular valve, such as a patient's aortic, tricuspid, or mitral valve. However, it should be understood that the features and concepts discussed herein may apply to products other than heart valve implants. For example, the features described herein may apply to other medical implants, e.g., other types of prosthetic devices, for use elsewhere in the body, such as within an artery, vein, or other body cavity or location. In addition, specific features of valves, delivery systems, etc., should not be considered limiting, and features of any one example described herein can be combined with features of other examples, as desired and appropriate. While certain examples described herein are described in connection with a transfemoral delivery approach, it will be understood that these examples may be used in connection with other delivery approaches, such as a transapical or transjugular approach. Furthermore, it will be appreciated that certain features described in connection with some embodiments may be incorporated with other embodiments, including features described in connection with different delivery approaches.

[0025] 1 illustrates one embodiment of a delivery system 10. The delivery system 10 may be used to deploy the implants disclosed herein or other forms of implants. Features of implants or prosthetic heart valves that may be utilized are disclosed in U.S. Provisional Patent Application No. 63 / 436,051, filed December 29, 2022, and U.S. Provisional Patent Application No. 63 / 533,458, filed August 18, 2023, the entire contents of each of which are incorporated herein by reference.

[0026] Implants, such as prosthetic heart valves, can be delivered to a subject's mitral or tricuspid valve annulus, or other heart valve location, in a variety of ways, including open-heart surgery, minimally invasive surgery, and percutaneous or transcatheter delivery through the subject's vasculature. An exemplary transfemoral approach is further described in U.S. Patent Publication No. 2015 / 0238315, published August 27, 2015, the entire contents of which are incorporated herein by reference. While delivery system 10 is described in connection with a percutaneous delivery approach, and more specifically, a transfemoral delivery approach, it will be understood that the features of delivery system 10 can be applied to other delivery approaches, including delivery systems for transapical delivery approaches.

[0027] The delivery system 10 can be used to deploy a prosthetic device, such as a replacement heart valve, at a location within a subject's body. The delivery system 10 can include multiple components, devices, or subassemblies. As shown in FIG. 1 , 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 desired. The delivery device 12 can include a housing in the form of an elongate shaft or shaft assembly 18 and a handle 16. The housing can be at the proximal end portion of the elongate shaft or shaft assembly 18. The shaft assembly 18 can include one or more shafts. Although multiple shafts can be provided according to embodiments herein, in some embodiments, a single shaft can be utilized.

[0028] The elongate catheter or delivery device 12 may be pre-attached to an implant (e.g., a prosthetic or replacement heart valve), and the delivery device 12 may be configured to facilitate delivery and implantation of the implant to a desired target location (e.g., the annulus of the mitral or tricuspid valve of the heart, among others). The implant may be pre-attached within the distal end portion of the shaft assembly 18 and removably anchored to one or more retaining components of the shaft assembly 18 during manufacture or assembly. The pre-loaded delivery device 12 may then be packaged, sterilized, and shipped for use by one or more clinicians. According to some embodiments, the delivery device 12 may be ready for use upon removal from the package, eliminating the need for a clinician to load the implant. In some embodiments, the delivery device 12 may be cleaned and loaded prior to use.

[0029] The elongate catheter or delivery device 12 may include an elongate shaft or shaft assembly 18 including a proximal end portion and a distal end portion, with a handle 16 coupled to the proximal end portion of the shaft assembly 18. The elongate catheter or delivery device 12 may be used to hold an implant (e.g., a prosthetic valve, a replacement heart valve) for advancing the implant through the vasculature to a treatment location. The elongate shaft or shaft assembly 18 may be for advancing the implant through a patient's vasculature to an implantation site (e.g., a native atrioventricular valve). In some embodiments, the elongate shaft or shaft assembly 18 may hold at least a portion of an expandable implant (e.g., a prosthetic valve, a replacement heart valve) in a compressed state for advancing such an implant within the body. The elongate shaft or shaft assembly 18 may then be used to control the expansion of the implant at a desired implantation location (e.g., a treatment location). In some embodiments, the shaft assembly 18 may be used to enable sequential, controlled expansion of the implant, as described in detail below.

[0030] The elongate shaft or shaft assembly 18 of the delivery device 12 can include one or more shafts. In some embodiments, multiple shafts may be provided. The multiple shafts may include one or more subassemblies or shafts, such as, for example, an outer sheath shaft or subassembly 20, a rail shaft or subassembly 22, a midshaft or midshaft subassembly 24, a tether assembly or subassembly 26, a release assembly or subassembly 28, and / or a nosecone shaft or subassembly. In some embodiments, the shaft assembly 18 of the elongate catheter or delivery device 12 may not have all of the subassemblies or shafts disclosed herein. The delivery device 12 may include multiple layers of concentric shafts, subassemblies, or lumens. The various lumens or shaft subassemblies may be described starting from the outermost layer. In some embodiments, the shafts or subassemblies described may be in a different radial order than described.

[0031] 2 shows a perspective view of one embodiment of the outer sheath shaft or subassembly 20 of the elongate catheter or delivery device 12 of the delivery system 10. The outer sheath shaft or subassembly 20 forms a radially outer covering or sheath that surrounds and encloses an implant-retaining area for retaining an implant and prevents at least a portion of the implant (e.g., a replacement heart valve or prosthetic valve) from radially expanding until it is ready for implantation. Specifically, the outer sheath subassembly 20 may prevent a distal end portion of the implant from radially expanding.

[0032] The outer sheath shaft or subassembly 20 can include an outer proximal shaft 30 having a proximal end portion operably coupled (e.g., via a threaded outer sheath adapter 32 at the proximal portion of the outer sheath shaft or subassembly 20) to a capsule actuator or knob 34 of the handle 16 (which may be the distal-most actuator or knob, as shown in FIGS. 24 and 25 ), such that rotation of the capsule knob 34 (e.g., clockwise or counterclockwise) moves the outer sheath subassembly 20 proximally and distally in a translational fashion. A capsule subassembly 36 can be attached to the distal end of the outer proximal shaft 30. The capsule of the capsule subassembly 36 is located at the distal end portion of the elongate shaft or shaft assembly 18 and is adapted to maintain the prosthetic heart valve in a compressed state. Components of the outer sheath shaft or subassembly 20 can form an outermost lumen for passage of other shafts or subassemblies.

[0033] The outer proximal shaft 30 may be a tube formed from plastic, but may also be formed from a metal hypotube or other material. The outer proximal shaft 30 may include an outer jacket or liner made from fluorinated ethylene propylene (FEP) material, polytetrafluoroethylene (PTFE) material, ePTFE material, or other polymeric material to provide a smooth and hemostatic outer surface of the outer proximal shaft 30. The outer proximal shaft 30 may include a connector (e.g., a flexible reflow member) at its distal end to facilitate connection or coupling to the capsule subassembly 36. At least a portion of the outer proximal shaft 30 may include a laser-cut hypotube having a flexibility pattern, such as a universal flexibility pattern. An interrupted spiral pattern or an interrupted coil may also be utilized.

[0034] FIG. 3 shows a side cross-sectional view of the capsule subassembly 36. The capsule subassembly 36 may include a distal hypotube or capsule stent 38, an inner liner inside the hypotube 38, a distal capsule tip 100, and one or more outer liners or jackets 102 surrounding the hypotube 38. The one or more outer liners or jackets 102 may comprise PEBAX or other suitable polymeric or thermoplastic elastomer materials, such as polytetrafluoroethylene (PTFE) or expanded polytetrafluoroethylene (ePTFE). The inner liner may comprise PTFE, which may be pre-compressed before application against the inside of the hypotube 38. The distal capsule tip 100 may include an atraumatic tip configured to act as a funnel to facilitate recapture (e.g., crimping) of a prosthetic valve or other implant. The distal capsule tip 100 may be constructed of polyetheretherketone (PEEK) or other thermoplastic, polymeric, or metallic materials. The distal capsule tip 100 may be loaded with a radiopaque material (e.g., a 5% to 40% barium sulfate loading) to facilitate detection (e.g., fluorescence) under radiographic imaging (e.g., fluoroscopy). The distal capsule tip 100 may fit within the open distal end of the hypotube 38.

[0035] FIG. 4 shows a perspective view of the distal hypotube or capsule stent 38. The capsule stent 38 may be formed from one or more materials, such as PTFE, ePTFE, polyether block amide (Pebax®), polyetherimide (Ultem®), PEEK, urethane, nitinol, stainless steel, and / or any other biocompatible material. The capsule stent 38 is preferably flexible yet maintains sufficient radial strength to maintain an implant (e.g., a replacement valve) within the capsule stent 38 without substantial radial deformation, which could increase friction between the capsule stent 38 and the implant contained therein. The capsule stent 38 also preferably has sufficient column strength to resist buckling and sufficient tear resistance to reduce or eliminate the possibility of the implant tearing and / or damaging the capsule stent 38. The proximal and / or distal ends of the distal hypotube or capsule stent 38 may include multiple laser-cut windows 104 adapted to render the proximal and / or distal ends fluorescent or echogenic to facilitate visualization under certain imaging modalities (e.g., non-invasive ultrasound imaging or invasive fluoroscopy). In some implementations, no separate radiopaque member or component is added to the hypotube 38 to facilitate imaging due to the presence of the laser-cut windows 104. The laser-cut windows 104 may also facilitate bonding the outer jacket 102 to the capsule stent 38 and inner liner by allowing an adhesive or other glue to flow through the laser-cut windows 104. One or more layers of connecting member formed from PEBAX or other suitable material may surround the laser-cut windows 104 to facilitate coupling the hypotube or capsule stent 38 to the distal capsule tip 100.

[0036] The hypotube 38 may be formed from a plastic or metal material. In some implementations, the hypotube 38 may be a metal hypotube. If made of metal, the metal material comprising the hypotube 38 may include a metal alloy, such as cobalt chrome, stainless steel, titanium, or a nickel-titanium alloy material. The coil structure or cut pattern of the proximal outer shaft 30 and / or hypotube 38 allows the proximal shaft 30 to follow the rail shaft or rail subassembly 22 in any desired direction. The cut pattern of the proximal outer shaft 30 and / or hypotube 38 may be modified (e.g., the number of cuts per revolution, pitch, spine distance) to control tension resistance, compression resistance, flexibility, and torque resistance. For example, the number of cuts per revolution may be in the range of 1.5 to 5.5, the pitch may be in the range of 0.005 inches to 0.15 inches, and the spine distance may be in the range of 0.015 inches to 0.125 inches. The hypotube 38 may advantageously provide both tension and compression. One or more outer liners or jackets 102 may allow the capsule subassembly 36 to be more flexible. The capsule hypotube 38 may bend in multiple directions. In some implementations, the distal end of the outer liner or jacket 102 may be positioned more proximally than the distal end of the hypotube 38.

[0037] The capsule subassembly 36 may have a similar diameter to the outer proximal shaft 30, or may have a different diameter. In some embodiments, the capsule subassembly 36 has a uniform or substantially uniform diameter along its length. In some embodiments, the capsule subassembly 36 can be 28 French or smaller in size (e.g., 27 French). In some embodiments, the capsule subassembly 36 may include a larger diameter distal portion and a smaller diameter proximal portion. The capsule subassembly 36, or capsule, may be configured to retain a compressed implant (e.g., a prosthetic valve) within the capsule subassembly 36 (e.g., within an implant retaining area 106 shown in FIG. 5 , which occupies the most distal 5 cm or 5 inches of the capsule subassembly 36). Additional structural and operational details of the capsule subassembly, such as those described with respect to the capsule in U.S. Patent Publication Nos. 2019 / 0008640 and 2019 / 0008639, which are incorporated herein by reference, may be incorporated into capsule subassembly 36.

[0038] The outer sheath shaft or subassembly 20 is configured to be independently 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 (shown in FIG. 24). The capsule knob 34 may be rotated to move or slide the outer sheath shaft or subassembly 20. Additionally, the outer sheath subassembly 20, along with the midshaft subassembly 24, tether assembly 26, release assembly 28, and / or nosecone subassembly, may slide distally and proximally relative to the rail subassembly 22. The control mechanism may be configured to control deflection of a portion of the elongate catheter or delivery device 12 of the delivery system 10, including a deflectable portion of the elongate catheter or delivery device 12.

[0039] FIG. 5 schematically illustrates an embodiment in which at least a portion of the length of one or more components of the capsule subassembly 36 (e.g., inner liner 108) may include excess material such that the capsule subassembly 36 includes built-in slack along a portion of its length (e.g., a portion of its length proximal to the implant retention area 106) to facilitate flexible bending of the capsule subassembly 36 (e.g., to navigate sharp turns in the heart or the vasculature surrounding the heart).

[0040] Figure 6 shows a perspective view of the rail shaft or subassembly 22 of the elongate catheter or delivery device 12 of the elongate shaft or delivery system 10 of Figure 1. Figure 6 shows a view that is nearly identical to Figure 2, except that the outer sheath subassembly 20 has been removed, thereby exposing the rail subassembly 22.

[0041] 7 further illustrates a cross-sectional view of the proximal and distal end portions of the rail subassembly 22 to visualize the pull wires or pull tethers that facilitate steering of the rail subassembly 22. The rail subassembly 22 can include a rail shaft 110 (or rail) generally attached to (and operably coupled with) the handle 16 at its proximal end. The rail shaft 110 can be composed of a rail proximal shaft 112 attached directly to the handle 16 at its proximal end, and a rail hypotube 114 attached to the distal end of the rail proximal shaft 112 (e.g., via a connector, ring-like structure, or insert 116). The rail subassembly 22 is operably coupled to the handle 16 via a primary bend adapter 118A at the proximal portion of the rail subassembly 22 (which controls the anterior-posterior trajectory of the distal end portion of the rail subassembly 22 via one or more distal pull tethers or wires 120A (shown in FIG. 7 )), via a secondary bend adapter 118B at the proximal portion of the rail subassembly 22 (which controls the anterior-posterior trajectory of the distal end 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 controls the medial-lateral trajectory of the distal end portion of the rail subassembly 22, which includes a side needleless injection port to facilitate irrigation and degassing functions). The rail proximal shaft 112 may include an intermittent spiral cut pattern along a majority of its length to facilitate compression. The rail hypotube 114 may further include an atraumatic rail tip 122 at its distal tip. The atraumatic rail tip 122 may not include a slit and is configured to extend up to 1 inch beyond the distal end of the rail hypotube 114 and is configured not to dig into the outer shaft subassembly 20 to avoid friction and fatigue and extend service life. These components of the rail subassembly 22 can form a lumen for the passage of other inner subassemblies.

[0042] FIG. 7 shows a side cross-sectional view of the rail shaft or subassembly 22 of FIG. 6. As shown in FIG. 7, one or more pull wires 120 may be attached to the inner surface of the rail hypotube 114 and used to apply force to the rail hypotube 114 and steer the rail subassembly 22. The pull wires 120 may extend distally from primary and secondary bend knobs 124A, B (shown in FIGS. 24 and 25) within the handle 16 to the rail hypotube 114. In some embodiments, the pull wires 120 may be attached at different longitudinal locations on the rail hypotube 114, thereby providing multiple bend positions within the rail hypotube 114 to enable multi-dimensional steering. For example, the rail hypotube 114 may provide a primary bend or bend along a medial / lateral trajectory and a secondary bend or bend along an anterior / posterior trajectory. Alternate directions of bend may be provided for deployment into the tricuspid valve. The rail hypotube 114 may form a bending portion for bending the elongate shaft or the other of the shafts of the shaft assembly 18 .

[0043] The rail hypotube 114 may include multiple circumferential slots (e.g., laser cut into the hypotube) to facilitate bending and flexibility. The rail hypotube 114 may generally be divided into several distinct sections. At the most 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 slots cut into the rail hypotube 114. Typically, two slots are cut around each circumferential location, forming approximately half of the circumference. Thus, two backbones are formed between the slots that extend the length of the hypotube 114. This is the section that may be guided by the proximal pull wire 120B. Moving further distally, there are locations where the slots may be avoided by connecting the proximal pull wires 120B. This section is just distal to the proximal slotted section 126P and may accommodate the location of an insert or pull wire connector 128.

[0044] Distal to the proximal pullwire connection region is distal slotted hypotube section 126D. This section is similar to proximal slotted hypotube section 126P, but may have significantly more slots cut out over a corresponding length. Thus, distal slotted hypotube section 126D may bend more easily and provide an increased bend angle compared to proximal slotted hypotube section 126P. In some embodiments, proximal slotted section 126P may be configured to undergo approximately a 90-degree bend at a half-inch radius, while distal slotted section 126D may bend through approximately a 180-degree bend at a half-inch radius. Additionally, as shown in FIGS. 6 and 7, the spine of distal slotted hypotube section 126D is circumferentially offset from the spine of proximal slotted hypotube section 126P. Thus, the two sections achieve different bending patterns, allowing for three-dimensional steering of the rail subassembly 22. In some embodiments, the spine may be offset by 30 degrees, 45 degrees, or 90 degrees, although the particular offset is not limiting. At the distal-most end of the distal slotted hypotube section 126D is located the distal pullwire connection region, which is again an unslotted section of the rail hypotube 114.

[0045] In some embodiments, one distal pull wire 120A may extend to the distal section of the rail hypotube 114 (e.g., to the rail tip 122) and two proximal pull wires 120B may extend to the proximal section of the rail hypotube 114, although other numbers of pull wires can be used and the particular quantity of pull wires is not limiting. For example, two distal pull wires 120A may extend to a distal location and a single proximal pull wire 120B may extend to a proximal location. In some embodiments, a ring-like structure or insert, known as a pull wire connector, attached inside the rail hypotube 114 may be used as an attachment location for the proximal pull wire 120B, such as insert 128. In some embodiments, the pull wire 120 may be directly connected to the interior surface of the rail hypotube 114.

[0046] The distal pull wire 120A may generally be connected to the distal end of the rail hypotube 114 (either by itself or through the rail tip connector 122). The proximal pull wire 120B may be connected (by itself or via an insert 128) approximately one-quarter, one-third, or one-half of the length of the rail hypotube 114 from the proximal end. In some embodiments, the distal pull wire 120A may pass through a small diameter pull wire lumen (e.g., a tube, hypotube, cylinder) attached on the interior of the rail hypotube 114. This may prevent the pull wire 120 from pulling on the rail hypotube 114 in proximity to the distal connection region. Additionally, the lumen may include a compression coil to reinforce the proximal portion of the rail hypotube 114 and prevent undesired bending. Thus, in some embodiments, the lumen is located only in the proximal portion (e.g., the proximal half) of the rail hypotube 114. In some embodiments, multiple lumens, either longitudinally spaced or adjacently arranged, may be used per distal pull wire 120A. In some embodiments, a single lumen is used per distal wire 120A. In some embodiments, a lumen may extend to a distal portion (e.g., the distal half) of the rail hypotube 114. In some embodiments, a lumen is attached to the exterior surface of the rail hypotube 114. In some embodiments, no lumen is used. In some embodiments, one or more compression coils 130 extend from insert 116 to insert 128. The compression coils 130 may be configured to bypass the load over the length between the distal primary inflection point and the proximal secondary inflection point. The compression coils 130 facilitate independent bending planes, such that when bending in one bending plane is desired, both bending planes are not actuated. The compression coil 130 may allow the proximal slotted hypotube section 126P to remain stiff for a particular bend in the distal slotted hypotube section 126D. The compression coil 130 may isolate the forces so that only the primary bend occurs.

[0047] With respect to the pair of proximal pull wires 120B, the wires can be spaced approximately 180° apart from each other to allow for bidirectional steerability. Similarly, if a pair of distal pull wires 120A is used, the wires can be spaced approximately 180° apart from each other to allow for bidirectional steerability. In some embodiments, the pair of distal pull wires 120A and the pair of proximal pull wires 120B can be spaced approximately 90° apart from each other. Opposing wires can be used to provide a bending resistance mechanism. In some embodiments, the pair of distal pull wires 120A and the pair of proximal pull wires 120B can be spaced approximately 0° apart from each other. However, other arrangements for the pull wires can be used as well, and the particular location of the pull wires is not limiting. In some embodiments, the distal pull wires 120A can pass through a lumen attached within the lumen of the rail hypotube 114. This prevents axial forces on the distal pullwire 120A from causing bending of the proximal section of the rail hypotube 114. The rail subassembly 22 is slidably positioned over the radially inner subassembly. As the rail hypotube 114 is bent, it presses against the other subassemblies, causing them to bend as well, allowing the other subassemblies of the delivery device 12 to be configured to steer with the rail subassembly 22 as a cooperative single unit, thereby providing full maneuverability of the distal end of the delivery device 12. The rail hypotube 114 is adapted to bend in a first direction in a first plane (the plane of deflection of the distal slotted hypotube section 126D) and in a second direction in a second plane (the plane of deflection of the proximal slotted hypotube section 126P), the second plane extending transversely or perpendicular to the first plane. Additional structural and operational details of rail subassemblies, such as those described with respect to rail assemblies in U.S. Patent Publication Nos. 2019 / 0008640 and 2019 / 0008639, which are incorporated herein by reference, may be incorporated into rail subassembly 22.

[0048] 8 and 9 schematically illustrate how the outer compression coil 130A and proximal pull wire 120B1 may have a longer length compared to the inner compression coil 130B and proximal pull wire 120B2 of the rail subassembly 22, thereby facilitating bending in one direction without occupying the same space and reducing blockage of the lumen upon bending.

[0049] Moving radially inward, the next subassembly is the midshaft or midshaft subassembly 24. FIG. 10 shows a perspective view of the midshaft subassembly 24 of the delivery device 12 of the delivery system 10. FIG. 11 shows a side view. The midshaft subassembly 24 may include a distal midshaft hypotube 132 generally attached at its proximal end to a proximal shaft 134, which in turn may be attached at its proximal end to the handle 16 (e.g., via a midshaft adapter 136 on the proximal portion of the midshaft subassembly 24), the distal midshaft hypotube 132, and a distal pusher 138 located at the distal end of the midshaft hypotube 132. These components of the midshaft subassembly 24 may form a lumen for passage of other inner subassemblies.

[0050] The midshaft subassembly 24 may be located within the lumen of the rail subassembly 22. The midshaft hypotube 132 may be formed from a metal alloy (e.g., cobalt chrome, nickel-chrome-cobalt alloy, nickel-cobalt based alloy, nickel-titanium alloy, stainless steel, and titanium). The midshaft hypotube 132 may include an intermittent spiral cut pattern. FIG. 10 shows a view similar to FIG. 6, but with the rail subassembly 22 removed, exposing the midshaft subassembly 24.

[0051] Like the other subassemblies, the midshaft hypotube 132 and / or the midshaft proximal tubing 134 may include tubing such as hypotubing or hypotubes (not shown). The tubing may be made from one of any number of different materials, including nitinol, stainless steel, and medical-grade plastic. The tubing may be a single-piece tubing or multiple pieces connected together. By using tubing made from multiple pieces, the tubing may provide different properties, such as stiffness and flexibility, along different sections of the tubing. The midshaft hypotube 132 may be a metallic hypotube. The midshaft hypotube 132 may have multiple slots / openings cut into it. In some embodiments, the cut pattern may be the same throughout. In some embodiments, the midshaft hypotube 132 may have different sections with different cut patterns. The midshaft hypotube 132 may be coated or encapsulated with a layer of ePTFE, PTFE, or other material, such that the outer surface of the midshaft hypotube 132 is generally smooth. At least a portion of the length of the midshaft proximal tube 134 may be covered by heat shrink tubing or heat shrink wrap.

[0052] The pusher 138 may be configured to radially hold a portion of the implant (e.g., a prosthetic valve) in a compressed configuration, such as the proximal end of the implant. The pusher 138 may compress the inlet end portion of the prosthetic heart valve. For example, the pusher 138 may be a ring or cover configured to radially cover the proximal end portion of the implant (e.g., a suture eyelet portion). The pusher 138 may also be considered part of the implant holding region 106 and may be at the proximal end of the implant holding region 106. The pusher 138 may include a frustoconical or cup shape riveted or otherwise secured to the distal end of the midshaft hypotube 132 on opposite sides thereof. The pusher 138 may be formed of PEEK material, an iron-based material, platinum-iridium, or other fluorescent material to facilitate radiography. The midshaft subassembly 24 may be positioned to be fixed relative to the handle. In some examples, the midshaft subassembly 24 may be independently slidable relative to the other subassemblies. The midshaft adapter 136 may be operably coupled to a depth knob 140 (shown in FIG. 24 ). The depth knob 140 may be utilized to effect ventricular / atrial movement of the elongate catheter shaft within the heart. Additional structural and operational details of the midshaft subassembly 24 may be incorporated into the midshaft subassembly 24, such as those described with respect to the midshaft assemblies in U.S. Patent Publication Nos. 2019 / 0008640 and 2019 / 0008639, which are incorporated herein by reference.

[0053] 12 , a tether assembly 26 may be utilized in the delivery system 10. The tether assembly 26 may comprise a portion of the elongate shaft 18 of the delivery device 12. In embodiments, the tether assembly 26 may extend within the midshaft subassembly 24, for example, within the lumen of the midshaft hypotube 132. The tether assembly 26 extends through the elongate shaft of the delivery device. The midshaft subassembly 24 may include a sheath extending over the tether assembly 26. Other sheaths in the delivery system 10 may include sheaths extending over the tether assembly 26. In embodiments, the tether assembly 26 may extend externally from the midshaft subassembly 24 or any other portion of the delivery device 12, as desired.

[0054] The tether assembly 26 may include a plurality of connecting tethers 142, each of which may be configured to connect to an implant. The connecting tethers 142 may be positioned at a distal end portion of the tether assembly 26. The tether assembly 26 may include a tether manifold 144 for connecting to the plurality of connecting tethers 142. The tether assembly 26 may include a flexible retaining tether 146, which may be coupled to the tether manifold 144 and extend proximally from the tether manifold 144. The flexible retaining tether 146 may extend proximally to a proximal end portion 148, which may couple to an adapter 150 or other component for coupling to the handle 16.

[0055] The flexible retention tether 146 may have various configurations and may comprise a wire or suture in embodiments. Other configurations of the flexible retention tether 146 may be utilized. The use of a wire or suture may create flexibility for the retention tether 146, allowing the flexible retention tether 146 to more easily deflect or bend with deflection or bending of the elongate shaft 18. Polymeric extrusions may also be utilized. For example, a portion of the elongate shaft 18, such as the rail shaft or subassembly 22, may form the bend in the elongate shaft 18. Thus, the elongate shaft 18 may have a deflectable portion configured to deflect transversely relative to the longitudinal axis of the elongate shaft 18. The flexible retention tether 146 may be configured to deflect at the deflectable portion. The flexible retention tether 146 may have increased flexibility and decreased stiffness relative to a tubular or hypotube shaft that may extend along the elongate shaft 18.

[0056] The flexible retention tether 146 may extend distally to a distal end portion 152 of the flexible retention tether 146. The flexible retention tether 146 may be configured to extend longitudinally along the elongate shaft 18 from the handle 16 (shown in FIG. 24 ) to the distal end of the elongate shaft 18. The flexible retention tether 146 extends proximally from the tether manifold 144 for engaging a tether actuator.

[0057] 13 shows an enlarged view of the distal end portion 152 of the flexible retention tether 146. A cross-sectional view of the tether manifold 144 is shown.

[0058] The tether manifold 144 is configured to retrieve the plurality of connecting tethers 142. The tether manifold 144 may couple the plurality of connecting tethers 142 to the distal end portion 152 of the flexible retaining tether 146. As shown in FIG. 13 , the tether manifold 144 may comprise a loop of material of the flexible retaining tether 146 and a sheath 149 extending over the loop of material. The tether manifold 144 may comprise the loop of material that comprises the wire of the flexible retaining tether 146, or may have another configuration in some embodiments. For example, the tether manifold 144 may include a loop of suture material that comprises the flexible retaining tether 146.

[0059] The sheath 149 may include tubing that can hold the multiple attachment tethers 142 in the loops of the manifold 144. The tubing may include shrink tubing or other forms of tubing that can be placed over the loops of the manifold. The sheath 149 may be flexible, thereby providing flexibility and conformal configuration for the manifold 144. In embodiments, material may be melted or reflowed at the connection of the attachment tethers 142 to the manifold. The material may include a polymeric material (e.g., PEBAX, HDPE, LDPE, etc.) that can be melted or reflowed. In embodiments, a combination of such materials and sheaths may be utilized. In embodiments, the length of the sheath 149 may be extended to improve the ability of the tether assembly 26 to be pushed through a lumen of the sheath (e.g., a lumen of the midshaft). The tether manifold may have other configurations in embodiments.

[0060] The multiple connection tethers 142 may extend from a tether manifold 144. The multiple connection tethers 142 may be configured to connect to the implant in various ways. For example, the multiple connection tethers 142 may each be configured to pass through an opening in a portion of the implant. Figure 18, for example, shows loop portions of the multiple connection tethers 142 passing through respective eyelets in the implant. The multiple connection tethers 142 may connect to the implant in other ways as desired.

[0061] In embodiments, the plurality of connecting tethers 142 may be flexible. Each of the plurality of connecting tethers 142 may comprise a suture or other form of flexible material. Each of the plurality of connecting tethers 142 may comprise a loop in embodiments, where the loop is configured to pass through an opening in a portion of the implant. Figure 20, for example, shows a loop extending through an eyelet in the implant.

[0062] The plurality of connecting tethers 142 may comprise a continuous suture in some embodiments. For example, with reference to FIG. 14 , the plurality of connecting tethers 142 may comprise loops formed by a continuous suture that is looped multiple times around an arm 154 of a tether manifold 144, with the arm 154 forming the loop. For example, a first length 156a of tether 142 may be looped around arm 154 to create a second length 156b of tether 142. The second length 156b may be looped at its distal end to form a distal loop, creating a third length 156c of tether 142. The third length 156c may be looped around arm 154 to create a fourth length 156d. The lengths may be repeatedly looped to create a desired number of distal loops for connecting to an implant. The plurality of connecting tethers 142 may comprise a continuous suture length. In embodiments, sheath 149 may be positioned over the proximal loop of coupling tether 142 and secure the proximal loop to arm 154. Arm 154 may comprise a wire in embodiments. Other configurations may be utilized in embodiments.

[0063] For example, FIG. 15 shows an embodiment in which the flexible retention member or tether 160 is woven or braided. The flexible retention tether 160 may include multiple sutures woven or braided into a larger suture. The tether manifold 162 may include multiple connecting tethers 164 separated from the flexible retention tether 160. The multiple connecting tethers 164 may be woven or braided from the flexible retention tether 160 or may include sub-portions of the weave or braid of the flexible retention tether 160. The multiple connecting tethers 164 may include loops woven or braided in the tether manifold 162. The braid may include a cylindrical braid or a flat braid, or may have another configuration in some embodiments.

[0064] Figure 16 shows an example in which a tether manifold 170 includes knots that connect a flexible retaining tether 172 to multiple connecting tethers 174. The tether assemblies of Figures 15 and 16 may be entirely suture-based and thus maintain flexibility 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.

[0065] Multiple attachment tethers may be positioned at the distal end portion of the elongate shaft 18 for attachment to an implant. Figure 17, for example, shows multiple attachment tethers 142 extending from the lumen of the midshaft 24, and in particular, the lumen of the pusher 138 of the midshaft 24. Multiple attachment tethers 142 may be positioned to attach to an implant.

[0066] 18, for example, illustrates a coupling configuration of multiple coupling tethers 142 to an implant 176. The coupling tethers 142 can extend through eyelets in the implant 176 and couple to the implant. The coupling tethers 142 may extend radially outward from the lumen of the midshaft.

[0067] In embodiments, multiple tether assemblies 26 may be utilized. For example, each tether assembly may utilize one or more of the coupled tethers 142. Each of the tether assemblies 26 may be independently controlled for selective control of implant expansion. For example, a first portion of the implant may be expanded before a second portion or retracted to control the position of the anchor. Controlled placement of the anchor may result. Multiple tether assemblies 26 may have other beneficial results.

[0068] In embodiments, release assembly 28 can be utilized to release multiple attachment tethers 142 from implant 176. Figure 19, for example, shows a side view of release assembly 28. Release assembly 28 can include one or more release tethers 180. Release tether 180, in embodiments, can be coupled to release tether manifold 182. Release tether manifold 182, in embodiments, can be coupled to retractable tether 184. Release tether 180, in embodiments, can comprise a flexible tether.

[0069] The retractable tether 184 may extend proximally to the proximal end portion 186. The proximal end portion 186 may, in some embodiments, be coupled to an adapter 189. The adapter 189 may, in some embodiments, be configured to engage with a release actuator 191 (shown in FIG. 25 ) or other component of the delivery system. The retractable tether 184 may be flexible and, in some embodiments, may comprise a wire or suture. The retractable tether 184 may comprise a filament that may be configured to extend along the elongate shaft 18 of the delivery device 12. In some embodiments, the retractable tether 184 may extend within the midshaft subassembly 24, for example, within the lumen of the midshaft hypotube 132. For example, the midshaft subassembly 24 may include a sheath extending over at least a portion of the release assembly. Other sheaths may be utilized as desired. In embodiments, retractable tether 184 may extend outside of midshaft subassembly 24 or any other portion of delivery device 12 as desired.

[0070] The release assembly 28 may be configured to be flexible and deflectable with the elongate shaft 18 of the delivery device 12. For example, at least a portion of the release assembly 28 may be configured to deflect with a deflectable portion of the elongate shaft 18.

[0071] The retractable tether 184 may extend to a distal end portion 188. The release tether manifold 182 may be positioned at the distal end portion 188. The release tether manifold 182 may include a collection of release tethers 180.

[0072] In some embodiments, the use of manifold 182 may be eliminated, and one or more of release tethers 180 may extend along the length of elongate shaft 18. Thus, in some embodiments, release assembly may include one or more of release tethers 180, which may be utilized to release multiple attachment tethers 142 from implant 176. In some embodiments, only one release tether 180 may be utilized (a single release tether passing through multiple loop portions).

[0073] In embodiments, one or more of the release tethers 180 may be utilized to extend through one or more of the loop portions of the coupled tether 142 to secure the implant to the loop portion. FIG. 20 , for example, shows one of the release tethers 180 a extending through each of the loop portions 188 a, b, c of each coupled tether 142 a, b, c. Passing the release tether 180 a through the loop portions 188 a, b, c may hold the implant to the loop portions 188 a, b, c because the loop portions 188 a, b, c extend through the eyelets of the implant. In embodiments, a single release tether 180 a may pass through multiple loop portions. In embodiments, a single release tether 180 a may pass through a single loop portion (e.g., a one-to-one correspondence between release tethers and loop portions).

[0074] The release tether 180 may have a variety of forms and may include a suture, a cable, a wire, a monofilament, a tape, or an extrusion. Other forms of the release tether 180 may be utilized in embodiments.

[0075] In embodiments, a single release tether may be utilized and coupled to the loop portion of the attachment tether. In embodiments, multiple release tethers may be utilized. For example, FIG. 18 illustrates a configuration in which three release tethers are utilized, each configured to extend through three loop portions. One or more release tethers may be configured to extend circumferentially between the loop portions of the attachment tether. More or fewer release tethers may be utilized as desired. In embodiments, a sheath or material for melting or reflowing may be utilized in the release tether manifold 182. In embodiments, knotting, weaving, or braiding with the release tethers may be utilized. Other forms of connection in the release tether manifold 182 may also be utilized.

[0076] 20 , release tether end 190 can include a free end that can be retracted from loop portions 188 a, b, c to release the implant from loop portions 188 a, b, c. Release tether retraction portion 192, or a proximal end portion, can extend into retractable tether 184 for retraction from loop portions 188 a, b, c. Retraction portion 192 can extend radially inward into a retaining sheath of the release assembly, which, in embodiments, can include midshaft 24 or another sheath.

[0077] 21 and 22 show a retraction sequence in which, for example, release tether 180a can be retracted from loop portions 188a, b, c. FIG. 21 shows, for example, that storage portion 192 has been retracted with end 190 withdrawn from loop portion 188a. Loop portion 188a can then be released from eyelet 193a. Storage portion 192 can continue to retract, releasing the remaining loop portions 188b, c from their respective eyelets 193b, c. The other release tethers can be released from their respective loop portions in a similar manner.

[0078] 23, for example, shows the loop portion of the connecting tether 142 released from the implant. The implant may be in an implanted or deployed configuration, positioned at an implantation site, such as a native heart valve.

[0079] The path of the attachment tether may vary in embodiment. For example, the attachment tether may pass through multiple eyelets on the implant (e.g., first through an eyelet in the outer valve frame and then through an eyelet in the inner frame). A release tether may lock the attachment tether at its most distal connection. When the release tether is retracted, the attachment tether may be free to pull through and decouple from both valve eyelets. Other forms of path may also be utilized.

[0080] Release assembly 28 may be utilized to hold the implant to tether assembly 26 during the recapture process of the implant. For example, tether assembly 26 may retract the implant to midshaft 24 when recapture is desired. Release assembly 28 may hold the implant to tether assembly 26 during such process. Release assembly 28 may be actuated at the desired point for final release of the implant at the implantation site.

[0081] FIG. 24 shows a perspective view of the housing or handle 16 of the delivery device 12. FIG. 25 shows a side cross-sectional view of the handle 16. The handle 16 includes a control mechanism for moving one or more shafts of the elongate catheter. The control mechanism may include multiple actuators or actuator assemblies, such as rotatable knobs, that can operate different components of the delivery system 10 (e.g., move the respective shafts or subassemblies of the shaft assembly 18). The distal end of the handle 16 includes an actuator in the form of a capsule knob 34. Rotating the capsule knob 34 in one direction can move the outer sheath subassembly 20 axially proximally, thereby unsheathing and deploying a distal portion (e.g., a ventricular portion) of the implant from the capsule subassembly 36. The capsule knob 34 can include a retraction mechanism for retracting the capsule or capsule subassembly 36, for example, to release the implant from the capsule. Rotating the capsule knob 34 in the opposite direction moves the outer sheath subassembly 20 (including the capsule subassembly 36) distally, resulting in the implant being recaptured, retrieved, or resheathed within the capsule subassembly 36. The outer sheath subassembly 20 may be translationally driven independently relative to the other subassemblies within the delivery device 12. The distal end of the implant may be released first, while the proximal end of the implant may remain radially compressed within the pusher 138 of the midshaft subassembly 24.

[0082] Moving proximally, the handle 16 includes a stabilizer mounting region 200 adapted to connect with a clamp of a stabilizer assembly configured to control the medial / lateral position of the delivery device 12. Moving further proximally are actuators in the form of a primary bend rail knob 124A and a secondary bend rail knob 124B. Rotating the primary bend rail knob 124A creates a bend in the primary bend portion, or in the distal slotted hypotube section 126D of the rail hypotube 114, changing the medial / lateral trajectory. Rotating the secondary bend rail knob 124B creates a bend in the primary bend portion, or in the proximal slotted hypotube section 126P of the rail hypotube 114, changing the anterior / posterior trajectory. However, the number of bend rail knobs 124A, B can be varied depending on the number of pull wires used.

[0083] Proximal to the secondary bend 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 nosecone shaft or subassembly relative to the rail subassembly 22. The depth knob 140 may also, in some configurations, move other subassemblies along with it relative to the rail subassembly 22 as well.

[0084] Further proximally located 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.

[0085] The most proximal knob is the nosecone knob 202, which, when rotated, moves the nosecone subassembly proximally and distally. The nosecone subassembly may be the radially innermost subassembly and may include a nosecone shaft having a distal end connected to the nosecone.

[0086] Figure 26 shows a schematic diagram of a delivery approach to the native tricuspid valve. As shown in Figure 26, in one embodiment, the delivery system 10 can be placed in the ipsilateral femoral vein 204 and advanced toward the right atrium 206. The approach, in some embodiments, can be from the inferior vena cava (or superior vena cava).

[0087] 26 shows the delivery system 10 extending from the ipsilateral femoral vein 204 to the right atrium 206. In embodiments of the present disclosure, a guidewire is not required to properly position the delivery system 10, although in other embodiments, one or more guidewires may be used.

[0088] Therefore, it may be advantageous for a user to be able to navigate the delivery system 10 through complex regions of the heart to position a replacement tricuspid valve in alignment with the native tricuspid valve. This can be accomplished with the systems disclosed above, with or without the use of a guidewire. The distal end of the delivery system 10 may be advanced into the right atrium 206. The user may then manipulate the rail subassembly 22 to target the distal end of the delivery system 10 to the appropriate region. Additionally, the user may apply torque to the entire delivery system 10 to further manipulate and control the position of the delivery system 10. In the fully flexed configuration, the user may then place the replacement valve in the proper position. This may advantageously enable delivery of a replacement valve, such as a native tricuspid valve, to an in situ implantation site.

[0089] 27 shows a schematic view of the distal end of the delivery system 10 approaching the native tricuspid valve. The distal end of the delivery system 10 may be positioned as desired relative to the implantation site prior to releasing the implant from the implant holding region.

[0090] 28 shows that with the tether assembly 26 coupled to the implant, the implant can be released from the delivery system 10. The position of the anchor relative to the leaflets of the native valve can be determined, and if in the proper position, the implantation procedure can proceed.

[0091] 29 shows the implant in an expanded configuration, with tether assembly 26 coupled to the implant. Release assembly 28 may hold tether assembly 26 to the implant in such a configuration.

[0092] The tether assembly 26 can be released from the implant, for example, using a release assembly 28. Figure 30 shows the release of the tether assembly 26. Figure 31 shows the implant deployed in place.

[0093] A similar deployment procedure can be utilized with the mitral valve, if desired. For example, a transseptal puncture can be performed from the right atrium 206 (shown in FIG. 26 ) to gain access to the left atrium 208. The user can pass the bent delivery system 10 through the transseptal puncture and into the left atrium 208. The user can then further manipulate the delivery system 10, bending the rail subassembly 22 even more. The delivery system 10 can then be advanced into the left atrium 208 and then toward the left ventricle 210. The implant can be deployed in a manner similar to that shown in FIGS. 27-31 .

[0094] In embodiments, the release assembly may be provided in the form of a disassembly assembly 212. Disassembly assembly 212 may be configured to connect to portion 213 of one or more attachment tethers 215 and disassemble the connection to portion 213 to release the implant from the elongate shaft of the delivery system.

[0095] Disassembly assembly 212, shown in FIG. 32, may include a heating element 214 in some embodiments. Heating element 214 may be configured to disassemble connections to portions 213 of one or more attachment tethers 215. Heating element 214 may be configured to apply heat, for example, to melt, destroy, vaporize, erode, dissolve, or otherwise disassemble connections to portions 213 of one or more attachment tethers 215. In some embodiments, one or more electrical conduits 216a,b may be provided that can pass electrical energy through heating element 214 to activate heating element 214. Disassembly assembly 212 may have other configurations in some embodiments.

[0096] The heating element 214 may be configured as a ring, as shown in FIG. 32 , or may have other configurations in embodiments (e.g., a strip of material, a coil, one or more pins, one or more hooks, one or more terminals, among others). The heating element 214 may comprise a heating filament configured to generate a high temperature as electrical energy (e.g., current) is passed through the heating element 214, or may have another configuration in embodiments. The heating element 214 may be made of materials such as nichrome (or an alloy of nickel and chromium), stainless steel, tungsten, platinum or tungsten alloys, nickel-iron-chromium alloys, or ceramic materials (e.g., molybdenum disilicide), among other forms of materials. Other forms of heating elements (e.g., semiconductor or polymer heating elements) may be utilized in embodiments. The heating element may generate heat using other methods in embodiments.

[0097] In embodiments, the heating element 214 may be configured to be positioned within a portion of one or more shafts of the elongate shaft or shaft assembly 18. For example, as depicted in the exploded view of FIG. 32, the heating element 214 may be positioned within the lumen of the midshaft or midshaft subassembly 24 (and correspondingly, within the lumen of the outer sheath shaft or subassembly 20). The heating element 214 may be specifically positioned within the distal pusher 138 of the midshaft or midshaft subassembly 24. For example, the heating element 214 may be positioned within the inner surface 218 (shown in FIG. 36) of the distal pusher 138. The heating element 214 may be positioned at the proximal end portion of the distal pusher 138 or at another desired location (e.g., the distal end portion). The heating element 214 may comprise a ring extending circumferentially inwardly of the inner surface 218 of the distal pusher 138. The ring shape may provide a central opening 220 (shown in FIG. 32) for passage of other components of the system (e.g., other sheaths or shafts or assemblies). Other configurations may be utilized in embodiments.

[0098] One or more electrical conduits 216 a,b may extend along the length of the elongate catheter or delivery device 12. The one or more electrical conduits 216 a,b may each include a respective distal end portion 222 a,b and a proximal end portion 224 a,b (shown in FIG. 35). The distal end portions 222 a,b may be coupled to the heating element 214 at respective junctions 226 a,b (shown in FIG. 32). The proximal end portions 224 a,b may be coupled to a power source 228 (shown in FIG. 35). The one or more electrical conduits 216 a,b may extend along the length of the elongate shaft or shaft assembly 18, particularly along the length of the shaft or subassembly that includes the heating element 214. For example, one or more electrical conduits 216 a,b may extend along the length of the midshaft or midshaft subassembly 24. The one or more electrical conduits 216a,b may extend externally of the midshaft or midshaft subassembly 24 (as shown in FIGS. 32, 35, and 36), or internally of the midshaft or midshaft subassembly 24 (e.g., within the lumen of the midshaft or midshaft subassembly 24), or may be completely or partially embedded in the wall of the midshaft or midshaft subassembly 24 (as shown in FIG. 40). The one or more electrical conduits 216a,b may extend in a similar manner along any other subassembly or shaft of the elongate shaft or shaft assembly 18.

[0099] In some embodiments, distal end portions 222a,b of one or more electrical conduits 216a,b may pass through a distal end portion of midshaft or midshaft subassembly 24 to connect to heating element 214 (as shown in the exploded view of FIG. 32). One or more electrical conduits 216a,b may, in some embodiments, pass from the exterior of midshaft or midshaft subassembly 24 to the interior of midshaft or midshaft subassembly 24 (e.g., distal pusher 138).

[0100] One or more electrical conduits 216 a,b may be insulating or otherwise configured not to transfer heat to the surrounding system or environment. For example, one or more electrical conduits 216 a,b may be insulated or covered with an insulating material (e.g., a jacket) to reduce the likelihood of heat being transferred to the surrounding system or environment. In embodiments, one or more electrical conduits 216 a,b may be made of a material that remains substantially the same temperature as electrical energy (e.g., current) passes through the one or more electrical conduits 216 a,b. Junctions 226 a,b may include, for example, a transition of material from the heating material of heating element 214 to the non-heating material of one or more electrical conduits 216 a,b. Other configurations may be utilized in embodiments.

[0101] The proximal end portions 224a, b of the one or more electrical conduits 216a, b may be configured to couple to a power source 228 (shown in FIG. 35) for providing electrical energy to the heating element 214 through the one or more electrical conduits 216a, b. The power source 228 may be configured to provide power to the heating element 214. The power source 228 may have any desired form (e.g., a battery, a power connector, a capacitor, among others). The power source 228 may be positioned on the handle 16 or may have another location as desired (e.g., the power connector may include a mains connector that connects to a power outlet, which may be a wall outlet or other form of outlet). An actuator 230 (shown in FIG. 35) may be utilized to selectively control the transmission of power through the one or more electrical conduits 216a, b.

[0102] 32, heating element 214 of disassembly assembly 212 can be configured to connect to one or more portions 213 of connecting tether 215. Heating element 214 may be configured as a ring, for example, to allow portion 213 to include loop portions 213a, b, c for extending over heating element 214. Loop portions 213a, b, c may comprise vertices of connecting tether 215. Loop portions 213a, b, c may comprise end portions of one or more connecting tethers 215 that may be looped over a filament comprising a ring. In embodiments, loop portions 213a, b, c may correspond to loop portions 188a, b, c, as shown in FIG. 20. However, loop portions 213a, b, c shown in FIG. 32 (which may be referred to as second portions of connecting tether 215) may be oriented proximally toward heating element 214 and may be looped over heating element 214. An intermediate portion of the attachment tether 215 (which may be referred to as a first portion of the attachment tether 215) may form a loop portion 232 (shown in FIG. 35) that may be attached to the implant to retain the implant on the elongate shaft 18. The loop portion 232 may protrude through a respective opening (e.g., eyelet) in a portion of the implant 176 to attach to the implant, for example, as discussed with respect to FIG.

[0103] The attachment tether 215 may include an end portion 234 that may be attached to a tether manifold or other attachment point for the tether 215. The tether manifold 236 (shown in FIG. 35) may be configured similarly to, for example, the tether manifold 144 depicted in FIG. 13, or may have another configuration in some embodiments. The end portion 234 may be looped around an arm of the tether manifold 236, or may have another configuration in some embodiments. The tether manifold 236 may be attached to a flexible retention tether 238, which may be configured similarly to the flexible retention tether 146 shown in FIG. 13, or may have another configuration, as desired. Other configurations of tether assemblies or subassemblies may be utilized as desired, including other configurations disclosed herein.

[0104] In embodiments, the use of a tether manifold and / or flexible retaining tether may be eliminated. For example, a first portion of tether 215 may include an end portion that couples to the implant. A second portion of tether 215 may include an opposite end portion that couples to heating element 214.

[0105] In embodiments, the attachment tether may have a first end that attaches to a heating element on the midshaft or midshaft subassembly 24 and an intermediate portion that forms a loop for attachment to the implant. The second end of the attachment tether may attach back to the midshaft or midshaft subassembly 24. The heating element may heat and release the first end of the attachment tether. The second end of the attachment tether may be retained by the midshaft or midshaft subassembly 24. Thus, the use of a tether manifold and / or a flexible retaining tether may be eliminated.

[0106] In embodiments, the attachment tether may have a first end that attaches to the heating element and an intermediate portion that forms a loop for attachment to the implant. The heating element may be positioned on the tether manifold and / or the flexible retention tether. The second end of the attachment tether may attach back to the tether manifold and / or the flexible retention tether. The heating element may heat and release the first end of the attachment tether. The second end of the attachment tether may be retained by the tether manifold and / or the flexible retention tether.

[0107] Other configurations and locations of couplings may be utilized in embodiments.

[0108] 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. An outer sheath shaft or subassembly 20 may, for example, extend over the implant to hold it in a compressed configuration. The outer sheath shaft or subassembly 20 (e.g., capsule subassembly 36) may be retracted proximally to allow the implant to expand radially outward in a manner similar to that disclosed herein. FIG. 33, for example, illustrates retraction of capsule subassembly 36 to allow the implant to expand radially outward. The proximal end of the implant is shown held by distal pusher 138.

[0109] The tether assembly or subassembly can be advanced distally, if desired, to allow the implant to be released from the distal pusher 138. The tether assembly or subassembly can be advanced to allow the connecting tether 215 to expand radially outward, thereby allowing the implant to be more fully expanded. FIG. 34, for example, shows the proximal end of an implant released from the distal pusher 138. The end portion 234 of the connecting tether 215 has been advanced distally with the flexible retaining tether 238 relative to the midshaft or midshaft subassembly 24 to allow the connecting tether 215 to expand radially outward.

[0110] At a desired point, the disassembly assembly 212 can be actuated to release the implant from the elongate shaft or shaft assembly 18. Referring to FIG. 35 , for example, a cross-sectional view of the disassembly assembly 212 is shown prior to disassembly of the connection to the attachment tether 215. The loop portion 232 of the attachment tether 215 can extend outwardly from the distal pusher 138, while end portions 213 a, b remain connected to the heating element 214. The opposing end portion 234 can remain connected to the tether manifold 236.

[0111] The actuator 230 may be activated upon the desired release. FIG. 36, for example, illustrates an activated configuration of the actuator 230. Electrical energy may be passed through the electrical conduits 216a,b to activate the heating element 214. The heating element 214 may be heated, and the heat may disintegrate the loop portions 213a,b to break the connection to the loop portions 213a,b. The heating element 214 may, for example, melt or otherwise disintegrate the loop portions 213a,b. The loop portions 213a,b may be severed. Thus, the loop portions 213a,b may include free ends 240a,b (shown in FIG. 36) that are not coupled to the heating element 214. The end portions 234 may remain connected to the tether manifold 236.

[0112] Figure 37, for example, shows a side view of the resulting configuration of coupled tether 215. Free ends 240a, b of coupled tether 215 (with additional free ends of each tether 215 shown in Figure 37) may be pulled through the eyelets of the implant to completely release the implant from elongate shaft 18. End portion 234 (shown in Figure 36) may remain connected to tether manifold 236 and may be withdrawn along with tether manifold 236 upon retraction of elongate shaft 18 from the implantation site. End portion 234 may be pulled proximally with tether manifold 236 to pull coupled tether 215 through the eyelets of the implant.

[0113] Other forms of disassembly assemblies may be utilized in embodiments. For example, a direct connection of the disassembly assembly to the implant frame may be utilized, with the direct connection being disassembled at a desired time. A material that can disintegrate at a desired time may be utilized to connect the implant frame to the disassembly assembly. Electrical energy or other forms of energy (e.g., thermal) may be utilized to disintegrate the connection. Chemical actuation may be utilized to disintegrate the connection in embodiments. Other forms of disassembly assemblies may be utilized in embodiments.

[0114] Other forms of disassembly with the attachment tether may also be utilized. Figures 38 and 39, for example, show an embodiment in which the disassembly assembly 242 includes an intermediate body 244 configured to disassemble. Disassembly of the intermediate body 244 can cause the connection to the attachment tether 246 to disassemble.

[0115] For example, attachment tether 246 may be configured similarly to attachment tether 215 and have an end or loop portion 248 that can connect to intermediate body 244. Loop portion 248 may extend over or otherwise be attached to intermediate body 244. Intermediate body 244 may have a ring shape or any other configuration desired (e.g., a strip of material, a coil, one or more pins, one or more hooks, one or more terminals, among others). Opposing end portion 250 of attachment tether 246 may be configured similarly to end portion 234 shown in FIG. 35 (e.g., may be attached to a tether manifold) or may have another configuration desired.

[0116] The heating element 252 may be utilized to degrade the intermediate body 244. The heating element 252 may, for example, be in contact with the intermediate body 244 and may be configured to transfer heat to the intermediate body 244, which may cause the intermediate body 244 to melt or otherwise degrade. For example, the intermediate body 244 may be made of a degradable material, such as a meltable filament, a biocompatible material, or other degradable material.

[0117] 39, for example, shows a disassembled intermediate body 244. The loop portion 248 is released from the intermediate body 244 allowing it to be released from the implant.

[0118] Other configurations of cutting and / or disassembly assemblies may be utilized. Any means for cutting, melting, disassembling, or detaching the attachment tethers from the implant to facilitate implantation within the body is envisioned and, therefore, within the scope of the present disclosure.

[0119] 40 and 41 show another embodiment of the disassembled assembly 258, in which the first electrical terminal 260a is displaceable relative to the second electrical terminal 260b and is configured to contact the second electrical terminal 260b to complete the circuit through which electrical energy passes through the heating element 262.

[0120] 40 , the heating element 262 may include a portion of a tether manifold 264 that connects to an end or loop portion 266 of a connecting tether 268. The end or loop portion 266 may extend over the heating element 262 or may be looped over the heating element 262. The heating element 262 may have a straight or linear shape and may comprise an arm of the tether manifold 264.

[0121] The attachment tether 268 may have an end 270 that attaches to an attachment point, such as a point on the interior surface of the distal pusher 138 or another point as desired.

[0122] First electrical terminal 260a may be coupled to a first electrical conduit 272a, which may extend to power source 228. First electrical terminal 260a may be configured to move with movement of tether manifold 264, as desired. For example, first electrical terminal 260a may be retracted or advanced with tether manifold 264, as desired.

[0123] The second electrical terminal 260b may be positioned on the shaft of the elongate catheter, for example, on the interior surface of the lumen of the midshaft or midshaft subassembly 24. The second electrical terminal 260b may be positioned on the interior surface of the distal pusher 138, or at another location, as desired. The second electrical terminal 260b may be in a fixed position or may be movable relative to one or more of the shafts of the elongate shaft or shaft assembly 18. As shown in FIG. 40 , the second electrical terminal 260b may be in a fixed position relative to the midshaft or midshaft subassembly 24. The first electrical terminal 260a may be movable relative to the midshaft or midshaft subassembly 24.

[0124] Second electrical terminal 260b may be coupled to a second electrical conduit 272b, which may extend to power source 228. In embodiments, second electrical conduit 272b may be embedded in a wall of midshaft or midshaft subassembly 24. In embodiments, second electrical conduit 272b may include a wall of midshaft or midshaft subassembly 24. For example, the wall may be electrically conductive to allow electrical energy transfer. Other configurations may be utilized, as desired.

[0125] The first electrical terminal 260a can be disconnected from the second electrical terminal 260b when the disassembly assembly 258 is not actuated. Such a configuration is depicted in FIG.

[0126] At a desired time, first and second electrical terminals 260 a, b can be moved relative to one another so as to contact terminals 260 a, b. Such movement can be generated in a variety of ways. In some embodiments, movement can occur based on tether manifold 264 being moved distally to distally advance coupling tether 268. Such movement can include deployment movement of tether manifold 264. In some embodiments, movement can be generated based on one or more other sliding movements of the shafts of the elongate catheters relative to one another.

[0127] In embodiments where movement occurs based on the tether manifold 264 being moved distally, movement can be utilized to ensure that actuation of the disassembly assembly cannot occur until the desired alignment of the shafts relative to one another. In the embodiment shown in FIGS. 40 and 41, the disassembly assembly 258 could not be actuated until the tether manifold 264 was advanced distally relative to the midshaft or midshaft subassembly 24. Such a feature can be utilized to ensure that the implant is not released prematurely or until the tether manifold 264 is advanced to the deployed position.

[0128] Figure 41, for example, shows tether manifold 264 advanced distally. First electrical terminal 260a and second electrical terminal 260b contact one another, completing a circuit through which electrical energy passes through heating element 262. Heating element 262 can break the connection to connecting tether 268, creating free ends 274a,b shown in Figure 41. By doing so, connecting tether 268 can be released from the implant.

[0129] Other configurations of the disassembled assembly may be utilized in the examples. The disassembled assembly feature may be utilized alone or in combination with any of the other examples disclosed herein.

[0130] Various forms of connecting tethers may be utilized, and the scope of the present disclosure should not be limited to any particular connecting tether configuration. Figures 42 and 43, for example, show configurations in which flexible retaining member or tether 280 is woven or braided. Flexible retaining tether 280 may include multiple sutures woven or braided into a larger suture. Tether manifold 282 may include multiple connecting tethers 284 separated from flexible retaining tether 280. Multiple connecting tethers 284 may be woven or braided from flexible retaining tether 280, or may include sub-portions of the weave or braid of flexible retaining tether 280. For example, flexible retaining tether 280 may include 24 threads, which may be broken down into three groups of eight threads each (for the three connecting tethers 284). Various divisions may be utilized as desired (e.g., a larger or smaller number of connecting tethers, or a larger or smaller number of threads per connecting tether). The braid may include a cylindrical braid or a flat braid, or may have another configuration in some embodiments.

[0131] The separate attachment tether 284 shown in FIG. 42 can be looped back toward the flexible retention tether 280, forming a loop portion 286 (shown in FIG. 43) of the attachment tether 284. The free end 288 of the attachment tether 284 can be looped back so as to be embedded within, for example, the tether manifold 282 or the flexible retention tether 280. FIG. 43, for example, illustrates such a configuration in partial cross section. The free end 288 of the attachment tether 284 can be inserted into and embedded within, for example, a central channel 290 of the tether manifold 282 or the flexible retention tether 280. The free end 288 can be embedded within the main portion 281 of the flexible retention tether 280 proximal to the tether manifold 282. Friction with the walls of the central channel 290 can hold the free end 288 of the attachment tether 284 within the central channel 290. Other configurations can be utilized to form the loop portion 286 in embodiments. In embodiments, the cross-sectional area of ​​main portion 281 of flexible retention tether 280 may be the same as the cross-sectional area of ​​the combined multiple connecting tethers 284. In embodiments, the length of each of multiple connecting tethers 284 from tether manifold 282 may be greater than 0.5 inches (or greater than 1 inch), or other lengths may be utilized in embodiments.

[0132] 44, free end 288 may pass through a wall of tether manifold 282 where it is locked to tether manifold 282 or flexible retaining tether 280. A portion of connecting tether 284 may be positioned within central channel 290 and may be retained within central channel 290. In embodiments, locking may occur by gluing or melting (e.g., reflowing) connecting tether 284 or other form of bonding.

[0133] 45 and 46 illustrate another embodiment in which one or more connecting tethers can include a woven or braided ring 292. FIG. 45 illustrates a woven or braided cylinder 294, which can be formed, for example, by weaving or braiding. The cylinder 294 can include a central opening 296 with a central lumen formed by the weaving or braiding process. A central axis can extend within and along the central lumen. The cylinder 294 can be cut transverse to the central axis of the cylinder 294 to form rings 292, as shown in FIG. 96. One or more horizontal cuts can also be made, which can be perpendicular to the central axis of the cylinder 294. The ring 292, shown in dashed lines in FIG. 45, can form part of the cylinder 294.

[0134] 46 shows the ring 292 cut and shown separated from the rest of the cylinder 294. The woven or braided ring 292 may surround a central opening 298.

[0135] Ring 292 may form one or more attached tethers. In embodiments, a portion of ring 292 may be attached to a tether manifold or flexible retention member or tether to form a loop suitable for attachment to an implant. In embodiments, ring 292 may form multiple attached tethers. FIG. 47, for example, shows portion 300 of ring 292 attached to tether manifold 302. At least two loop portions 304a, b may extend distally from tether manifold 302. Each loop portion 304a, b may include an attached tether for attachment to a portion of the implant. In embodiments, more rings 292 may be utilized to create a desired number of attached tethers. In embodiments, two portions of ring 292 may be attached to tether manifold 302, creating three resulting loop portions and attached tethers. In embodiments, multiple rings 292 can be coupled to tether manifold 302 to create a desired number of connected tethers (e.g., two rings 292 can be coupled to provide four connected tethers or six connected tethers, three rings 292 can be coupled to provide six connected tethers or nine connected tethers), and more or fewer rings 292 can be utilized as desired.

[0136] FIG. 47 shows a partial cross-sectional view of the attachment of ring 292 to tether manifold 302. At least a portion of tether manifold 302 can overlap woven or braided ring 292 to attach the woven or braided ring to tether manifold 302. For example, length 306 of tether manifold 302 may extend over ring 292, with free end 308 embedded within channel 310 of tether manifold 302. A configuration can hold ring 292 to tether manifold 302. In an embodiment, free end 308 can be anchored to tether manifold 302 in a manner similar to that shown in FIG. 44. In an embodiment, free end 308 can be glued or melted (e.g., reflowed) to tether manifold 302 to attach ring 292 to tether manifold 302.

[0137] 48-50 show a configuration in which a tether manifold 312 includes warp yarns 314 woven with weft yarns 316, and multiple connected tethers 318 each include a continuation of the warp yarns 314 of the tether manifold 312 that lacks any weaving with weft yarns 316.

[0138] For example, referring to FIG. 48 , a woven fabric 320 may be formed that includes a section 322 that includes warp yarns 314 and weft yarns 316. The length of section 322 may be set as desired during the weaving process. At a desired point during the weaving process, the weaver may discontinue use of weft yarn 316. A section 324 may be formed that includes warp yarns 314 and lacks any woven fabric with weft yarn 316 (because use of weft yarn 316 has been discontinued). The length of section 324 may be set as desired. The length of section 324 may be set based on the desired length of the connecting tether in an embodiment.

[0139] At a desired point during the weaving process, the use of the weft yarn 316 may be resumed. The resulting section 326 may be formed with a section 324 between sections 322, 326. Section 326 may include the weft yarn 316. The length of section 326 may be set as desired. FIG. 52 shows exemplary lengths of sections 322, 324, 326 that may be produced. Section 322 may extend, for example, at least 50 inches, 60 inches, 70 inches, or 80 inches. Section 326 may extend, for example, at least 50 inches, 60 inches, 70 inches, or 80 inches. For example, section 324 may extend, in embodiments, at least 1 inch, 2 inches, or 3 inches. Various other lengths may be utilized as desired. The lengths may be determined during the weaving process.

[0140] For example, the length 328 and width 331 of the fabric 320 can be cut to create a tether assembly of a desired size. The width 331 can be set as desired. The width 331 can be cut into a desired number of connected tethers, for example, that can be utilized in the tether assembly. FIG. 49 shows the resulting cut fabric 320', including a width with nine warp yarns 314, for example, that can be utilized to create nine connected tethers. More or fewer warp yarns can remain in the cut fabric 320'.

[0141] Section 326 may be folded back over section 322, thus forming overlapping section 329 (shown in FIG. 50). Gluing or melting (e.g., reflow) may be used to bond sections 326, 322 together. The fold in section 326 may result in a loop of warp threads 314 positioned longitudinally between sections 322, 326 of FIG. 49. The loop of warp threads 314 may include a looped connecting tether 330. The connecting tether 330 may be used to connect to a portion of the implant, as desired. The length of connecting tether 330 may be half the length of section 324 shown in FIG. 49 in some embodiments.

[0142] In some embodiments, the threads may comprise braided sutures. The threads comprising the warp threads may be high strength braided sutures, and / or the threads comprising the weft threads may be high strength braided sutures. In some embodiments, any tether disclosed herein may comprise braided sutures or other forms of material.

[0143] The warp and weft weaves shown in FIGS. 48-50 may include flat weaves or flat ribbon configurations. For example, flat section 326 may be stacked on flat section 322 to form flat overlapping section 329. In some embodiments, stacked configurations may be utilized. FIG. 51 shows an exemplary warp and weft weave pattern for a stacked configuration. Vertical stacks 332 and horizontal stacks 334 may be provided. Weft yarns 336 may follow the pattern depicted in FIG. 51 (with the weft path of the first shuttle, or shuttle 1, shown by short dashes and short dot-dashed lines, and the weft path of the second shuttle, or shuttle 2, shown by long dashes and long dot-dashed lines). The stacked configuration may form a tether manifold and / or a flexible retention member or tether, as desired. The stacked configuration may be layered on itself to form a looped, joined tether in a manner similar to that disclosed with respect to FIG. 50. The layered stack configuration may result in 18 warp threads at the tether manifold. The stack configuration may be glued or melted (e.g., reflowed) to bond the sections together. In embodiments, more or less than 9 warp threads may be utilized, as desired.

[0144] Other configurations may be utilized in embodiments. FIG. 53, for example, illustrates a configuration in which multiple threads 340a, b, c, d form respective loops 342a, b, c, d. Each thread 340a, b, c, d includes a portion 344, 346 coupled to a respective bobbin 348, 350. The loops 342a, b, c, d may each be coupled to a loop base 352 having a respective number of loop retainers 354a, b, c, d. The loop retainers 354a, b, c, d may include hooks or have other configurations as desired. The loop base 352 and loop retainers 354a, b, c, d may hold the loops 342a, b, c, d during the weaving or braiding process.

[0145] Loops 342a, b, c, d may be looped onto a respective one of loop retainers 354a, b, c, d. The bobbins 348, 350 of each thread 340a, b, c, d may be coupled to actuators 355a, b (shown in FIG. 54) that move the bobbins 348, 350 to form a weave or braid of threads 340a, b, c, d. FIG. 54, for example, shows the resulting weave or braid 356 formed by the movement of bobbins 348, 350. The threads 340a, b, c, d are woven or braided, with loops 342a, b, c, d remaining at the distal ends of the weave or braid. Loop retainers 354a, b, c, d hold the loops 342a, b, c, d during the weaving or braiding process.

[0146] The formation of the weaving or braiding 356 of threads 340a, b, c, d depicted in FIG. 54 may continue for a desired length. At a desired point, the weaving or braiding 356 process may be interrupted and the proximal end of the weaving or braiding 356 may be cut. The resulting configuration is shown in FIG. 55. A tether manifold 360 may include a combination of the respective loops 342a, b, c, d, and a flexible retaining tether 362 may include the weaving or braiding 356 of threads 340a, b, c, d. A bonded tether may include loops 342a, b, c, d that are retained during the weaving or braiding process. The tether manifold 360 may include the weaving or braiding of the bonded tether threads 340a, b, c, d (including loops 342a, b, c, d). A proximal end portion 358 of the weave or braid 356 may include the proximal free ends of the threads 340a,b,c,d that form respective loops 342a,b,c,d.

[0147] 42-55 may be utilized alone or in combination with each other or with any other embodiment disclosed herein. In various embodiments, nine linking tethers are shown and described. However, any greater or lesser number of loops or linking tethers (e.g., at least three, at least six, at least nine, at least twelve, etc.) may be utilized.

[0148] Figure 56A shows one embodiment of a release assembly 600 or subassembly. The release assembly 600 or subassembly may include features of other release assemblies or subassemblies (e.g., release assembly or subassembly 28) unless otherwise noted. The release assembly 600 includes a release tether 602 having a proximal end coupled to a release tether manifold 604. Representative release tethers 602a, b are shown in cross section in Figure 56B. A retractable tether 606 (or other elongated structure) extends proximally from the release tether manifold 604.

[0149] Release tether manifold 604 may include splices of release tethers 602. For example, as shown in the cross-sectional view of FIG. 56B, release tether 602a may be spliced ​​through release tether 602b to form two lengths 608, 610, each extending from splice 612. Thus, two release tether bodies may be utilized, forming three release tethers 602. In embodiments, a greater or lesser number of release tethers may be utilized.

[0150] The splice 612 may be covered by a sheath 614 that may secure the splice connection between the release tethers 602 a, b. The sheath 614 may include tubing, shrink tubing, or a reflow material that secures the splice connection. The release tether 602 may comprise a cord, cable, wire, or other form of tether and may be flexible. The sheath 614 may include a polymeric material (e.g., plastic) that may secure the connection between the release tethers 602 a, b. In embodiments, the splice connection may include a Blummel splice, although other forms of splices may be utilized in embodiments. A knot connection (e.g., a bow knot, a knot, an Alpine loop knot, or other forms of knot) may be utilized in embodiments.

[0151] Release tether 602, release tether manifold 604, and retractable tether 606 have sufficient flexibility and axial strength to withstand the proximal tension used to retract and detach release tether 602, thereby allowing the attached tether to be detached from the implant. Release assembly 600 is preferably flexible to accommodate bending or deflecting portions of the elongate shafts or shaft assemblies disclosed herein. Other forms of release assemblies or subassemblies may be utilized in embodiments.

[0152] Any of the features of FIG. 56A or FIG. 56B may be utilized alone or in combination with each other or any other embodiment disclosed herein.

[0153] Figure 57 shows a variation in the configuration of release assembly 600 or subassembly. In the configuration of Figure 57, multiple release tethers (with three release tethers 603a, b, c shown in Figure 57) are utilized. Release tethers 603a, 603c have respective proximal ends 605a, c positioned within sheath 614 at release tether manifold 607. The release tethers branch off from release tether manifold 607. Proximal ends 605a, c join release tether 603b at release tether manifold 607. Sheath 614 joins ends 605a, c with release tether 603b, and ends 605a, c have offset lengths. Thus, a tapered junction at release tether manifold 607 can result.

[0154] Any of the features of FIG. 57 may be utilized alone or in combination with each other or any other embodiment disclosed herein.

[0155] 58 and 59 show another embodiment of a tether assembly 630 or subassembly. The tether assembly 630 or subassembly may include features of other tether assemblies or subassemblies unless otherwise noted. The tether assembly 630 includes a connecting tether 632 having a proximal end connected to a tether manifold 634. A flexible retaining tether 636 extends proximally from the tether manifold 634.

[0156] Flexible retention tether 636 may include a wire or tube that extends distally to tether manifold 634. Flexible retention tether 636 may include a receiving portion or lumen 638 (shown in FIG. 59) for receiving tether manifold 634. Tether manifold 634 may include arm lengths 640 a, b (shown in FIG. 59), for example, that may extend into receiving portion or lumen 638. Arm lengths 640 a, b may be crimped or otherwise coupled to receiving portion or lumen 638 to secure tether manifold 634 to flexible retention tether 636. Other forms of flexible retention tether and coupling to tether manifold may be utilized in embodiments.

[0157] 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 comprise a wire or cable that may be shaped to form the loop portion 642. The tether manifold 634 and the flexible retention tether 636 may be constructed with axial stiffness or column strength to allow distal pushing or compressive forces to be transmitted along the length of the tether manifold 634 and the flexible retention tether 636 (e.g., to advance the coupled implant distally or to expand the coupled implant). The tether manifold 634 and the flexible retention tether 636 may have lateral flexibility to allow them to conform to bending or deflecting portions of the elongate shafts or shaft assemblies disclosed herein.

[0158] A proximal end portion 641 of attachment tether 632 is attached to tether manifold 634. Proximal end portion 641 of attachment tether 632 may be looped around loop portion 642 of arm 640 in a manner similar to that disclosed with respect to FIG. 14 . For example, a single tether body may alternatively be looped around arm 640 to form multiple attachment tethers 632. In embodiments, other forms of attachment may be utilized.

[0159] In embodiments, a sheath 644 may be provided that may extend over proximal end portion 641 of attachment tether 632. Sheath 644 may be positioned distal to loop portion 642 of arm 640, or in embodiments, may extend proximally over loop portion 642 of arm 640. Sheath 644 may function to secure the connection of attachment tether 632 to tether manifold 634 and may increase the stiffness of the connection to improve the transmission of distal pushing or compressive forces transmitted to attachment tether 632. Sheath 644 may comprise tubing, shrink tubing, or reflow material at proximal end portion 641 of attachment tether 632.

[0160] In embodiments, the attachment tether 632 can have a length from a proximal end portion 641 of the attachment tether 632 to a loop, attachment, or distal end portion 646 of the attachment tether 632 that extends the length of the attachment tether 632 along a bending or deflecting portion of an elongate shaft or shaft assembly disclosed herein. Thus, in embodiments, the attachment tether 632 can extend through a bending or deflecting portion (e.g., a portion corresponding to a primary or secondary bend in a rail shaft), with the tether manifold 634 and flexible retaining tether 636 remaining proximal to such portion. Other configurations may be utilized in embodiments.

[0161] Any of the features of Figure 58 or Figure 59 may be utilized alone or in combination with each other or any other embodiment disclosed herein.

[0162] Variations in the configuration of tether assemblies or subassemblies may be provided in the embodiments. Figure 60A, for example, shows a perspective view of tether manifold 650 of tether assembly 652 or subassembly (shown in partial cross section in Figure 60B).

[0163] The tether manifold 650 may include one or more couplers 654 for coupling to a coupling tether 656 (shown in FIG. 60B). The couplers 654 may include cutouts or tabs in the surface of the material around which the coupling tether 656 can loop and be coupled. The cutouts or tabs may be in the surface (e.g., the outer surface) of the flexible retaining tether 658. The couplers 654 may be evenly spaced apart circumferentially (e.g., three couplers 654 equidistant, e.g., 120 degrees apart from one another). Other spacings or numbers of couplers 654 (e.g., at least two, at least three, at least four, etc.) may be utilized as desired.

[0164] The coupling tether 656 may be looped around the coupler 654 as a single loop. Referring to FIG. 60B , for example, coupling tether 656a may include two loops: a proximal loop 660a looped around coupler 654 and a distal loop 662a at the distal end of coupling tether 656a. Other coupling tethers (e.g., coupling tethers 656b, c) may be similarly looped. Other forms of connection (e.g., an alternating loop configuration as disclosed with respect to FIG. 14 or other forms of connection) may be utilized. More or fewer coupling tethers may be utilized as desired. With three couplers 654 and three coupling tethers 656 each, a total of nine coupling tethers 656a-i (shown in FIG. 61) may be utilized. More or fewer may be utilized as desired.

[0165] The coupling tether 656 can extend along an outer surface 663 of the tether manifold 650, as depicted in cross section in Figure 60B.

[0166] In embodiments, friction feature 664 may be provided at a distal end portion of tether manifold 650. Friction feature 664 may comprise cutouts, ridges, or recesses in outer surface 663 of tether manifold 650 to enhance friction with coupling tether 656 extending along outer surface 663. In embodiments, distal end portion of tether manifold 650 may comprise a flexible material, yet have sufficient column strength to withstand distal compressive forces.

[0167] In embodiments, sheath 666 may extend over proximal end portion 668 of coupling tether 656 over tether manifold 650. Sheath 666 may function to secure the connection of coupling tether 656 to tether manifold 650 and may increase the stiffness of the connection to improve the transmission of distal pushing or compressive forces transmitted to coupling tether 656. Sheath 666 may include tubing, shrink tubing, or reflow material at proximal end portion 668 of coupling tether 656. Sheath 666 is shown in FIG. 61 , for example, to contour to the shape of coupling tether 656 through the reflow or shrink process. In embodiments, sheath 666 may extend proximally to cover coupler 654.

[0168] FIG. 61 shows a cross-sectional view of tether manifold 650 taken along line II in FIG. 60B . The portion of tether manifold 650 covered by connecting tether 656 may include a tube having an internal lumen 670. Flexible retention tether 658 may further comprise a tube, and internal lumen 670 may extend proximally relative to the length of flexible retention tether 658. Internal lumen 670 may be adapted to allow a nosecone shaft to extend therethrough in an assembly of a delivery system. Internal lumen 670 may be adapted to allow a release assembly or subassembly disclosed herein to extend therethrough. In embodiments in which a release assembly extends through internal lumen 670, the release tether may be housed proximally through internal lumen 670. Connecting tether 656 may be positioned symmetrically about tether manifold 650. Other configurations may be utilized in embodiments. For example, the nosecone shaft may be positioned within the internal lumen 670 and the release assembly may be positioned external to the internal lumen 670 in some embodiments.

[0169] Any of the features of Figures 60A-61 may be utilized alone or in combination with each other or any other embodiment disclosed herein.

[0170] Variations in the configuration of the delivery system disclosed herein may be provided. Figures 62-66 illustrate a delivery system 680 or delivery catheter that includes a variation of the configuration of the delivery system 10 discussed with respect to Figures 1-31. Features of the delivery system 10 are utilized in the features of the delivery system 680 shown in Figures 62-66 unless otherwise noted. Other features of the delivery system 10 discussed with respect to Figures 1-31, such as any shaft or subassembly configuration, may be utilized in the delivery system 680. Features of other embodiments disclosed herein (e.g., the embodiment of Figures 32-61) may be utilized in the delivery system 680, as desired.

[0171] A delivery system 680 can be used to deploy a prosthetic device, such as a prosthetic heart valve, at a location within a subject's body. The delivery system 680 includes multiple components, devices, and / or subassemblies. As shown in FIG. 62 , the delivery system 680 can include an elongate catheter, delivery device, or delivery catheter 681, and a stabilizer assembly 1120 (shown in perspective view in FIG. 120 ), and other components, as desired. The delivery catheter 681 can include a housing in the form of an elongate shaft or shaft assembly 683 and a handle 682. The housing can be at a proximal end portion of the elongate shaft 683 or shaft assembly. The elongate shaft 683 can include one or more shafts. Although multiple shafts can be provided according to embodiments herein, in some embodiments, a single shaft can be utilized. The elongate shaft 683 or shaft assembly can be configured similarly to the elongate shaft or shaft assembly 18, unless otherwise noted. The elongate shaft 683 may be adapted to deflect around a bent portion 685 of the elongate shaft 683. The other portion of the elongate shaft 683 may slide along the bent portion 685 to change the depth of the distal end portion of the elongate shaft 683.

[0172] Examples of control mechanisms or handles 682 are shown in FIGS. 63-66. Control mechanisms or handles 682 include variations of handles 16 described above with respect to FIGS. 1-31. Control mechanisms or handles 682 may be adapted to control deflection of elongate shaft 683 or a shaft assembly, among other mechanisms (e.g., controlling the depth of elongate shaft 683, the height of elongate shaft 683, and / or the expansion or release of an implant). Handle 682 comprises a housing including a first housing 684 and a second housing 686. Second housing 686 may be coupled to a rail shaft or subassembly. First housing 684 may be coupled to one or more shafts adapted to slide relative to the rail shaft or subassembly to vary the depth of such shafts relative to the rail shaft or subassembly. The first housing 684 may include a distal portion 688 and a proximal portion 690, with the second housing 686 extending at a medial portion of the first housing 684, intermediate the distal portion 688 and the proximal portion 690, and around the first housing 684 (as shown in the cross-sectional view of FIG. 66).

[0173] The handle 682 includes a capsule actuator or knob 692 (which may include features of the capsule actuator or knob 34), respective actuator assemblies, deflection actuators, control knobs, or bending knobs 694A,B (which may include features of the respective bending knobs 124A,B), a knob assembly 696 or depth actuator or knob, a coupled tether actuator or knob 698, and a release actuator or knob 700. The actuators may operate in a manner similar to the other respective actuators disclosed herein unless otherwise noted.

[0174] The configuration of one or more shafts or subassemblies may differ from that disclosed with respect to delivery system 10. Figures 67-70, for example, illustrate variations of rail shafts or subassemblies 22 that may be utilized in embodiments herein.

[0175] 67, an elongate shaft 710 or rail shaft or subassembly is shown. The elongate shaft 710 may include features of the rail shaft or subassembly 22 and may be adapted to be deflected in one or more planes. Other shafts of the delivery system 680 disclosed herein may be adapted to slide relative to the elongate shaft 710 to vary the depth of those shafts along the elongate shaft 710.

[0176] The elongate shaft 710 or rail shaft or rail subassembly includes an outer sheath 712. The outer sheath 712 has a distal end portion 714, a proximal end portion 716 (shown in FIGS. 65 and 66 ) and a length between the distal end portion 714 and the proximal end portion 716.

[0177] The outer sheath 712 includes a proximal shaft 718 or rail-proximal shaft, which may be configured similarly to the proximal shaft 112 unless otherwise noted. The distal end of the proximal shaft 718 may abut the hypotube 720 of the outer sheath 712. The hypotube 720 may include features of the hypotube 114 unless otherwise noted. The hypotube 720 may include a bend configured to form a bend for another shaft or sheath of the delivery system to follow. The other shaft or sheath slides over the bend to change the depth of the shaft or sheath relative to the hypotube 720.

[0178] The distal end 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 end portion 722 a, 724 a, 726 a and a proximal end portion 722 b, 724 b, 726 b. The pattern of slots or cuts in each section 722, 724, 726 can define the orientation, plane, or deflection of the respective section 722, 724, 726.

[0179] The distal-most section 722 may include features of the distal slotted hypotube section 126D, unless otherwise noted. The distal-most section 722 may be adapted to bend or deflect in a plane to generate a primary deflection of the elongate shaft 710 (e.g., a medial-lateral trajectory). In tricuspid implementations, a variation may be provided in which the distal-most section 722 provides an anterior-posterior trajectory.

[0180] The mid-section 724 may include features of the proximal slotted hypotube section 126P, unless otherwise noted. The mid-section 724 may be adapted to bend or deflect in a plane transverse or perpendicular to the plane of the distal-most section 722 to produce a secondary deflection (e.g., an anterior-posterior trajectory) of the elongate shaft 710. When adapted to deploy a prosthetic heart valve within a native tricuspid valve, a variation may be provided in which the mid-section 724 provides a septal-lateral trajectory.

[0181] The proximal section 726 can be adapted to bend or deflect in the opposite direction within the plane of the distal-most section 722. Thus, the proximal section 726 is adapted to provide height for the elongate shaft 710 or delivery catheter 681 in a direction opposite to the depth direction. The height direction is opposite the deflection direction of the distal-most section 722 to vary the height of the distal end of the delivery catheter (e.g., with a capsule or tip). Other height directions (e.g., offset from the plane of the distal-most section 722) can be utilized in embodiments.

[0182] The proximal section 726 may be positioned distal to and adjacent to the proximal shaft 718. In embodiments, the order of the slotted sections may be varied as desired. For example, the height bending section may comprise the intermediate section, and the secondary deflection section (in a plane transverse to the height) may comprise the proximal section. Other variations may be provided in embodiments.

[0183] A pull tether or pull wire assembly may be utilized to actuate the elongate shaft 710 and deflect the bending portion of the hypotube 720 or outer sheath 712. Figure 68 shows a perspective view of a pull tether or pull wire assembly that may be utilized (the outer sheath 712 is omitted from Figure 68 for clarity).

[0184] 68 includes multiple connectors, ring-like structures, or inserts 730, 732, 734, and 736. Connectors, ring-like structures, or inserts 730, 732, and 734 may comprise pull tether or pull wire connectors and may be used 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.

[0185] FIG. 69 shows an enlarged perspective view of the distal-most insert 730. The insert 730 may include an outer flange or lip 744 that may seat against the distal end of the distal-most slotted section 722. The outer flange or lip 744 may prevent proximal movement of the insert 730 when proximal tension is applied by the pull tether 738. The insert 730 may include an alignment feature 746, such as a tab, that couples with the distal-most slotted section 722 and may rotationally align the insert 730 relative to the distal-most slotted section 722. Additionally, torque may be transmitted through the alignment feature 746. In embodiments, other forms of the alignment feature 746 may be utilized. The alignment feature 746 may comprise a groove or pocket into which a finger or tab on the distal-most slotted section 722 engages. The finger or tab may be pressed into the groove or pocket.

[0186] The insert may include a coupler 748, such as a post, that may couple with a distal end portion 750 of the pull tether 738. The insert 730 may include a channel 752 for passage of a shaft or sheath (e.g., a midshaft or midshaft subassembly, a tether assembly or subassembly, a release assembly or subassembly, and / or a nosecone shaft or subassembly). In embodiments, the configuration of the insert 730 may be varied.

[0187] FIG. 70 shows an enlarged perspective view of the first intermediate insert 732. The first intermediate insert 732 may be positioned between the distal-most 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 end portion 722b of the distal-most slotted section 722. The proximal sleeve portion 756 is inserted into the distal end portion 724a of the intermediate slotted section 724. The distal sleeve portion 754 may include an alignment feature 758, which may be configured similarly to the alignment feature 746 shown in FIG. 69. The proximal end portion 757 may include an alignment feature 760, which may be configured similarly to the alignment feature 746 shown in FIG. 69.

[0188] A central portion of first intermediate insert 732 may include an outer flange 761 that may be positioned between distal-most slotted section 722 and intermediate slotted section 724. Outer flange 761 may seat against the distal end of intermediate slotted section 724. Outer flange 761 may prevent proximal movement of insert 732 when proximal tension is applied by pull tether 740.

[0189] The first intermediate insert 732 may include a coupler 762 , such as a post, that may couple with a distal end portion 764 of the pull tether 740 .

[0190] 68 , the second intermediate insert 734 may be configured similarly to the first intermediate insert 732, but may be adapted to couple to a distal end 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 tether.

[0191] The pull tether or pull wire may include a distal pull tether 738 or pull wire having a distal end portion 750 (coupled to the pull tether adapter 735 shown in FIG. 65 ) and a proximal end portion. The pull tether 738 may extend along the length of the outer sheath 712. The distal end portion 750 may be coupled to the outer sheath 712 and may extend proximally from the coupling or attachment point to the pull tether adapter 735, as shown in FIG. 69 . The pull tether 738 may pass through a lumen within the inserts 732, 734, 736 and extend to the pull tether adapter 735. The distal end portion 750 of the distal pull tether 738 is coupled to the distal end portion 722a of the distal slotted portion 722.

[0192] The connection of the distal end portion 750 of the pull tether 738 to the coupler 748 may be a looped connection, as shown in FIG. 69 , where a length of the pull tether 738 is looped around the coupler 748. The looped pull tether 738 may be crimped onto itself, or the looped length of the pull tether 738 may extend proximally relative to the pull tether adapter 735 along the length of the outer sheath 712.

[0193] A lumen in the form of a compression coil 770 may surround at least a portion of the pull tether 738 between the first intermediate insert 732 and the second intermediate insert 734. The compression coil 770 may operate in a manner similar to that disclosed with respect to the compression coil 130 and may help reduce deflection of the intermediate slotted section 724 upon deflection of the distal slotted section 722. The compression coil 770 may include a distal end portion 772 and a proximal end portion 774, where the distal end portion 772 is adapted to abut the first intermediate insert 732 and the proximal end portion 774 is adapted to abut the second intermediate insert 734. The compression coil 770 has a larger diameter than the pull tether 738 and therefore may be sized to not pass through the lumen of the first intermediate insert 732 and the second intermediate insert 734. The compression coil 770 is positioned proximal to the proximal end portion 722b of the distal slotted section 722.

[0194] The compression coil 776 may surround at least a portion of the pull tether 738 between the second intermediate insert 734 and the proximal insert 736. The compression coil 776 may operate in a manner similar to that disclosed with respect to the compression coil 130 and may help reduce deflection of the proximal slotted section 726 upon deflection of the distal slotted section 722. The compression coil 776 may include a distal end portion 778 and a proximal end portion 780, where the distal end portion 778 is adapted to abut the second intermediate insert 734 and the proximal end portion 780 is adapted to abut the proximal insert 736. The compression coil 776 is sized so as 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 end portion 724b of the intermediate slotted section 724.

[0195] The tube 782 or hypotube may surround at least a portion of the distal pull tether 738 between the proximal insert 736 and the housing 784, or the rail adapter to which the outer sheath 712 couples. The tube 782 may include a distal end portion 786 (which extends into the housing 784 or rail adapter shown in FIG. 65 ) and a proximal end portion. The distal end portion 786 of the tube 782 is adapted to abut the proximal insert 736.

[0196] A proximal end portion of the pull tether 738 may be coupled to a pull tether adapter 735. The pull tether adapter 735 is adapted to slide longitudinally along the handle 682 to proximally create axial tension on the pull tether 738 or distally release or reduce axial tension. The pull tether adapter 735 engages with a control knob or bending knob 694A, which has a threaded connection to the outer surface of the handle 682 and a non-threaded or fixed rotational connection with the pull tether adapter 735. Thus, rotation of the bending knob 694A moves the knob 694A proximally or distally, moving the pull tether adapter 735 proximally or distally for axial tension or release of axial tension on the pull tether 738. A deflection actuator or actuator assembly comprising the bending knob 694A and the pull tether adapter 735 applies tension to the pull tether 738, deflecting the elongate shaft 710. The elongate shaft 710 bends at a bent section or distal slotted section 722. In an embodiment, a deflection actuator or actuator assembly can be utilized to push the pull tether 738 distally axially to actively unbend the rail shaft.

[0197] The pull tether or pull wire may include an intermediate pull tether 740 or pull wire having a distal end portion 764 (coupled to a pull tether adapter 790 shown in FIG. 65 ) and a proximal end portion. The pull tether 740 may extend along the length of the outer sheath 712. The distal end portion 764 may be coupled to the outer sheath 712 and may extend proximally from the coupling or attachment point to the pull tether adapter 790, as shown in FIG. 70 . The pull tether 740 may pass through a lumen within the inserts 734, 736 and extend to the pull tether adapter 790. The distal end portion 764 of the intermediate pull tether 740 is coupled to the distal end portion 724a of the intermediate slotted portion 724.

[0198] The connection of the distal end portion 764 of the pull tether 740 to the coupler 762 can be a looped connection, as shown in Figure 70. The pull tether 740 can be coupled in a similar manner to the pull tether 738.

[0199] Referring again to FIG. 68 , a 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 upon deflection of the intermediate slotted section 724. The compression coil 800 can include a distal end portion 802 and a proximal end portion 804, where the distal end portion 802 is adapted to abut the second intermediate insert 734 and the proximal end portion 804 is adapted to abut the proximal insert 736. The compression coil 800 can have a larger diameter than the pull tether 740 and thus be sized not to pass through the lumen of the second intermediate insert 734 and the proximal insert 736. The compression coil 800 is positioned proximal to the proximal end portion 724b of the intermediate slotted section 724.

[0200] The tube 810 or hypotube may surround at least a portion of the pull tether 740 between the proximal insert 736 and the housing 784, or the rail adapter to which the outer sheath 712 couples. The tube 810 may include a distal end portion 812 (which extends into the housing 784 or rail adapter shown in FIG. 65 ) and a proximal end portion. The distal end portion 812 of the tube 810 is adapted to abut the proximal insert 736.

[0201] A proximal end portion of the intermediate pull tether 740 may be coupled to a pull tether adapter 790 (shown in FIG. 65 ). The pull tether adapter 790 is adapted to slide longitudinally along the handle 682 proximally to create axial tension on the intermediate pull tether 740 or distally to release or reduce axial tension. The pull tether adapter 790 is engaged with a control knob or bending knob 694B, which has a threaded connection to the outer surface of the handle 682 and a non-threaded rotational connection with the pull tether adapter 790. Thus, rotation of the bending knob 694B moves the knob 694B proximally or distally, which moves the pull tether adapter 790 proximally or distally for axial tension or release of axial tension on the pull tether 740. A deflection actuator or actuator assembly, comprising bend knob 694B and pull tether adapter 790, applies tension to pull tether 740 to deflect elongate shaft 710. Elongate shaft 710 bends at bend or intermediate slotted portion 724. Elongate shaft 710 deflects in a plane transverse or perpendicular to the plane of deflection of distal slotted section 722.

[0202] The pull tether or pull wire may include a proximal pull tether 742 or pull wire having a distal end portion 820 (coupled to the knob assembly 696 shown in FIG. 65 ) and a proximal end portion. The pull tether 742 may extend along the length of the outer sheath 712. The distal end portion 820 may be coupled to the outer sheath 712 in a manner similar to that shown in FIG. 70 and may extend proximally from the coupling or attachment point to the knob assembly 696. The pull tether 742 may pass through a lumen within the proximal insert 736 and extend to the knob assembly 696. The knob assembly 696 may actuate the pull tether 742 to bend the elongate shaft 710 to change the height of the distal end portion of the delivery catheter (e.g., including the capsule or tip).

[0203] The connection of distal end portion 820 of pull tether 742 to the coupler of second intermediate insert 734 can be a looped connection similar to the connection shown in Figure 70. Distal end portion 820 of proximal pull tether 742 couples to distal end portion 726a of proximal slotted portion 726.

[0204] 68 , tube 830 or hypotube may surround at least a portion of pull tether 742 between proximal insert 736 and housing 784, or the rail adapter to which outer sheath 712 couples. Tube 830 may include a distal end portion 832 (extending to housing 784 or rail adapter shown in FIG. 65 ) and a proximal end portion. Distal end portion 832 of tube 810 is adapted to abut proximal insert 736.

[0205] Tension applied to the proximal pull tether 742 deflects the elongate shaft 710 further in the opposite direction within the plane of deflection of the distal slotted section 722. The tension can create a height in the direction opposite to the depth of the delivery catheter 681.

[0206] Variations on the configuration of the assemblies shown in Figures 67-70 may be provided. Figures 71-75, for example, show variations in which lumens in the form of tubes 782, 810 abut the respective compression coils 800, 840. Distal end portions 786, 812 of the respective tubes 782, 810 abut the respective proximal end portions 842, 804 of the compression coils 840, 800. The features of the assemblies shown in Figures 67-70 apply to the features of the assemblies of Figures 71-75 unless otherwise stated.

[0207] The lumen or compression coil 800 may not be directly connected to the outer sheath 712, but may be slidable relative to the pull tether 740. The tube 810 may not be directly connected to the outer sheath 712, but may be slidable relative to the pull tether 740. Forces exerted on the compression coil 800 (e.g., by the insert 734′ or via other forces on the compression coil 800) may be transmitted through the tube 810 via adjacent contact between the compression coil 800 and the tube 810. The compression coil 800 may extend the length of the proximal slotted section 726 before contacting the tube 810.

[0208] 72, insert 734' comprises a variation of second intermediate insert 734 shown in FIG. 68. Insert 734' includes a channel 852 for compression coil 840 to extend therethrough. Channel 852 is sized larger than lumen 854 for pull wire 740 to pass therethrough and has a larger diameter for passage of compression coil 840.

[0209] The lumen or compression coil 840 comprises a compression coil having the length of coils 770, 776 shown in FIG. 68 and extends continuously from the first intermediate insert 732′ to the location of the proximal insert 736′. The mechanism of compression coils 770, 776 is otherwise applied to compression coil 840. Compression coil 840 may not be directly connected to outer sheath 712 but may be slidable relative to pull tether 738. Tube 782 may not be directly connected to outer sheath 712 but may be slidable relative to pull tether 738. Force exerted on compression coil 840 (e.g., by insert 732′ or via other forces on compression coil 840) may be transmitted through tube 782 via adjacent contact between compression coil 840 and tube 782. Compression coil 840 may extend the length of proximal slotted section 726 and intermediate slotted section 724 before contacting tube 782.

[0210] Inserts 730′, 732′, 734′, 736′ may include variations of the respective inserts 730, 732, 734, 736 shown in FIG. 68. Inserts 730′, 732′, 734′ may each include a respective formed sleeve 841, 843, 845 having a respective plate or flange 847, 849, 851 that engages the outer sheath 712. Insert 736′ may lack a formed sleeve and may include a plate or flange for abutting the tube 830. Features of inserts 730, 732, 734, 736 are otherwise applicable to inserts 730′, 732′, 734′, 736′.

[0211] 73 shows the configuration of the housing 784 or rail adapter to which the proximal end portion 716 of the outer sheath 712 mates. The proximal end portions of the tubes 782, 810, 830 are shown.

[0212] The housing 784 or rail adapter may be slidably engaged with the proximal end portion 716 of the outer sheath 712. The outer sheath adapter 870 may be coupled to the proximal end portion 716 of the outer sheath 712, for example, in a fixed, immovable manner. Thus, the outer sheath adapter 870 may move longitudinally or axially with longitudinal or axial movement of the outer sheath 712 in accordance with forces applied to the outer sheath 712. The outer sheath adapter 870 may include an alignment feature 871 (e.g., a clock-like or key-type protrusion) that may align the outer sheath adapter 870 with the housing 784 or rail adapter. The alignment feature 871 may maintain the rotational orientation of the outer sheath 712 and, in embodiments, may be utilized to transmit torque forces.

[0213] FIG. 74 shows a perspective view of a housing 784 or rail adapter with the outer sheath adapter 870 removed from view for clarity. The housing 784 includes a receiver 880 for sliding engagement with the outer sheath adapter 870. The housing 784 may include an alignment receiver 882 or slot that receives an alignment feature 871. The alignment feature 871 may slide within the alignment receiver 882 or slot. The sliding motion may be axial motion longitudinally along the axis of the outer sheath 712. The alignment feature 871 may prevent rotation about the axis by the outer sheath 712.

[0214] The housing 784 or rail adapter may include a support plate 890 including one or more openings 892 for the pull tethers 738, 740, 742 to pass through. The openings 892 may be positioned in rotational alignment with the locations of the pull tethers 738, 740, 742 to allow the pull tethers 738, 740, 742 to pass proximally relative to their respective actuator assemblies. The openings 892 may be sized so that the proximal end 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 that abuts the proximal end portions of the tubes 782, 810, 830. In embodiments, the surface 894 may include a countersink or annular ring for receiving each of the proximal end portions of the tubes 782, 810, 830. In embodiments, multiple plates may be stacked on top of one another to create a countersunk hole or annular ring (with the proximal plate having a hole diameter smaller than the hole diameter of the distal plate to form the countersunk hole or annular ring).

[0215] The support plate 890 is fixedly coupled to the housing 784 or held in a stationary configuration within the housing 784. Thus, proximal forces exerted on either the compression coils 840, 800 or the tubes 782, 810, 830 act on the support plate 890. The support plate 890 has sufficient strength to support loads generated on the compression coils 840, 800 or the tubes 782, 810, 830 due to actuation of either the pull tethers 738, 740, 742. Forces exerted on the compression coil 840 are transmitted to the support plate 890 through the tube 782, for example. Forces exerted on the compression coil 800 are transmitted to the support plate 890 through the tube 810, for example. The lack of a direct connection between the compression coils 840 , 800 and their respective lumens in the form of tubes 782 , 810 , 830 and outer sheath 712 allows forces to be transmitted and carried by support plate 890 .

[0216] The sliding engagement between the housing 784 and the proximal end portion 716 of the outer sheath 712 allows the outer sheath 712 to slide relative to the support plate 890. Thus, forces that may be received by the outer sheath 712 may produce movement of the outer sheath 712 relative to the housing 784, reducing the possibility of adverse compression or damage to the outer sheath 712 during actuation of any of the pull tethers 738, 740, 742.

[0217] The force carried by support plate 890 and the sliding movement of outer sheath 712 relative to housing 784 may reduce the presence of crosstalk or interference between actuation of each pull tether 738, 740, 742. The actuation force of pull tether 738 may be carried by support plate 890 rather than intermediate slotted portion 724, for example, thus reducing deflection of intermediate slotted portion 724 (and proximal slotted portion 726) upon deflection of distal slotted portion 722. Similarly, the actuation force of pull tether 740 may be carried by support plate 890 rather than proximal slotted portion 726, therefore reducing deflection of proximal slotted portion 726 upon deflection of intermediate slotted portion 724.

[0218] Figure 75 shows a cross-sectional view of the assembly of Figures 73 and 74. The assemblies of Figures 73-75 can be incorporated into a handle 682. Figure 76, for example, shows a representative configuration. Thus, the handle 682 can receive a support plate 890, a housing 784 or rail adapter, and an actuator assembly (in the form of control or bend knobs 694A, 694B and respective adapters 735, 790). The sliding engagement between the housing 784 or rail adapter and the proximal end portion 716 of the outer sheath 712 allows the outer sheath 712 to slide relative to the handle 682 (particularly the second housing 686 of the handle 682).

[0219] The configuration shown in Figures 73-75 may be utilized in the assembly shown in Figures 71 and 72 or in the assembly shown in Figures 67-70.

[0220] Any of the features of Figures 67-76 may be utilized alone or in combination with each other or any other embodiment disclosed herein.

[0221] Variations in the actuator assemblies or deflection actuators of the pull tethers 738, 740 may be provided in the embodiments. Figures 77-80 show variations in which actuator assemblies 900, 902 are utilized and configured to apply tension to the respective pull tethers 738, 740 and simultaneously apply a distal compression force to the respective lumens (tubes 782, 810 and / or compression coils 840, 800).

[0222] A cross-sectional view of each distal or primary actuator assembly 900 and intermediate or secondary actuator assembly 902 is shown in FIG. 77. The distal or primary actuator assembly 900 includes a bendable knob or control knob 904. The bendable knob or control knob 904 is not threadably engaged with the exterior surface of the handle of the delivery system. Rather, the handle (having a second housing 906 corresponding to second housing 686) lacks threadable engagement with the bendable knob or control knob 904.

[0223] The bendable knob or control knob 904 engages the pull tether adapter 910 with a fixed rotational coupling (e.g., a non-threaded coupling) that allows the control knob 904 to rotate relative to the pull tether adapter 910 and apply a longitudinal or axial force to the pull tether adapter 910. The pull tether adapter 910 moves longitudinally with the control knob 904. The pull tether adapter 910 couples to a proximal end portion of the pull tether 738 in a manner similar to the pull tether adapter 735.

[0224] The bend knob or control knob 904 engages the lumen adapter 912 with a threaded rotational coupling. Thus, rotation of the control knob 904 causes the lumen adapter 912 to slide longitudinally, with a first direction of rotation producing longitudinal retraction and a second direction producing longitudinal advancement.

[0225] Lumen adapter 912 is adapted to contact the proximal end of tube 782. Thus, the length of tube 782 may be longer than in the embodiment shown in Figures 73-75 and the use of support plate 890 may be eliminated. Lumen adapter 912 may directly contact and abut the proximal end of tube 782.

[0226] A fixed rotational connection to the pull tether adapter 910 and a threaded rotational connection to the lumen adapter 912 cause the control knob 904 to rotate and change the spacing 914 between the lumen adapter 912 and the pull tether adapter 910. Rotation in a first direction may increase the spacing 914, and rotation in the opposite direction may decrease the spacing 914. Thus, rotation of the control knob 904 in a single direction drives the pull tether adapter 910 and the lumen adapter 912 longitudinally in opposite directions.

[0227] Compression coil 840 and tube 782 may be of the configuration discussed with respect to FIGS. 71 and 72 . Thus, a distal force applied to tube 782 may be transmitted to compression coil 840 and insert 732′. Thus, tube 782 and compression coil 840 may stiffen, resulting in a reduced likelihood of deflection of intermediate slotted portion 724 (and proximal slotted portion 726). Crosstalk between deflection of one of the slotted portions and deflection of another of the slotted portions may be reduced. Actuator assembly 900 is adapted to simultaneously apply a tension force to pull tether 738 that is equal and opposite to the distal compression force applied to the lumen (e.g., compression coil 840 and tube 782).

[0228] 78 and 79 illustrate exemplary operation of actuator 900. Referring to FIG. 78, lumen adapter 912 and pull tether adapter 910 are at a distance 914 from one another. In FIG. 79, control knob 904 has been rotated to increase the distance 914 from one another. Pull tether adapter 910 is retracted, retracting pull tether 738 and thus deflecting distal slotted portion 722. Tube 782 and compression coil 840 have the distal compression force applied by lumen adapter 912 transferred to first intermediate insert 732′. Thus, the proximal portion of outer sheath 712 stiffens, reducing the possibility of crosstalk. Control knob 904 can be rotated in the opposite direction, reducing the tension in pull tether 738 and the compression force on insert 732′.

[0229] In an embodiment, threaded and non-threaded may be alternated such that control knob 904 has a threaded engagement with pull tether adapter 910 and a non-threaded or fixed rotational connection with lumen adapter 912 .

[0230] Intermediate or secondary actuator assembly 902 may include components of distal or primary actuator assembly 900 and may operate in a similar manner. Intermediate or secondary actuator assembly 902 may include, for example, a lumen adapter 920 that abuts a proximal end portion of tube 810 and a pull tether adapter 922 that couples to a proximal end portion of pull tether 740. Features of distal or primary actuator assembly 900 may be utilized in intermediate or secondary actuator assembly 902.

[0231] In embodiments, the lumen configuration may vary such that the compression coil extends along the length of the outer sheath 712 and contacts the lumen adapters 912, 920. In embodiments, the compression coil may be omitted and the tubes 782, 810 may extend distally to the inserts 732′, 734′. Other configurations may be utilized in embodiments. In embodiments, the compression coils disclosed herein may include compression tubes with cuts that allow the compression tubes to bend or deflect. Cut compression hypotubes may include lumens that may be utilized in place of or in combination with a compression coil.

[0232] FIG. 80 shows an exterior side view of the actuator assemblies 900, 902 on the second housing 906.

[0233] Any of the features of Figures 77-80 may be utilized alone or in combination with each other or any other embodiment disclosed herein.

[0234] 65 and 66, the elongate shaft 710 or rail shaft or subassembly may be coupled to a second housing 686 (alternatively referred to as a rail housing). The first housing 684 may be longitudinally or axially slidable relative to the second housing 686. The first housing 684 may be coupled to other shafts or sheaths of the delivery system 680, such as the outer shaft sheath or subassembly 20, the midshaft or midshaft subassembly 24, the tether assembly or subassembly 26, the release assembly or subassembly 28, and the nosecone shaft or subassembly.

[0235] As disclosed herein, the elongate shaft 710 or rail shaft or subassembly can form a curved portion of the elongate shaft of the delivery catheter (including a combination of assemblies 20, 24, 26, 28). The sliding movement of the first housing 684 relative to the second housing 686 can advance or retract the assemblies 20, 24, 26, 28 relative to the curved portion, changing the depth of the distal end portion of the elongate shaft of the delivery catheter relative to the curved portion of the elongate shaft 710 or rail shaft or subassembly. The first housing 684 and assemblies 20, 24, 26, 28 can be advanced distally relative to the second housing 686 to create depth, and the first housing 684 and assemblies 20, 24, 26, 28 can be retracted proximally relative to the second housing 686 to reduce depth.

[0236] The knob assembly can be utilized to vary the depth of the distal end portion of the delivery catheter elongate shaft relative to the elongate shaft 710 or the curved portion of the rail shaft or subassembly. The knob assembly can be further configured to actuate the height of the delivery catheter elongate shaft.

[0237] In some embodiments, the knob assembly may be adapted to be rotated in a first direction to create a depth of the distal end portion of the elongate shaft of the delivery catheter relative to the elongate shaft 710 or the curved portion of the rail shaft or subassembly. The knob assembly may be rotated in a second direction to create a height of the elongate shaft of the delivery catheter in the opposite direction to the depth. Figures 81-104 show examples of knob assemblies that may be utilized.

[0238] FIG. 81 shows a cross-sectional view of one embodiment of a knob assembly 696. The knob assembly 696 is positioned on the handle 682. The knob assembly 696 may include a first portion 930, or inner body, or longitudinally fixed body. The knob assembly 696 may include a second portion 932, or outer body, or longitudinally slidable body. The first portion 930 may include internal threads 934 adapted to engage threads 936 on the exterior surface of the first housing 684. The first portion 930 may include external threads 937 adapted to engage the second portion 932. The first portion 930 may 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.

[0239] The first portion 930 is adapted to rotate such that the threaded engagement with the first housing 684 causes the first housing 684 to slide longitudinally relative to the second housing 686. Thus, the depth of the distal end portion of the delivery catheter varies relative to the curved portion of the elongate shaft 710 or rail shaft or subassembly.

[0240] Second portion 932 includes internal threads 940 adapted to engage with external threads 936 of first portion 930. Thus, rotating second portion 932 relative to first portion 930 advances or retracts second portion 932 relative to first portion 930. Second portion 932 includes a fixed rotation coupling 942 having a pull tether adapter 946 for proximal pull tether 742 (shown, for example, in FIGS. 68 and 71 ). Second portion 932 comprises a gripping portion or control knob for knob assembly 696 adapted for gripping and manipulation by a user. An outer surface 956 of second portion 932 is adapted for gripping and manipulation.

[0241] The proximal pull tether assembly includes a proximal pull tether 742 and a pull tether adapter 946. A distal end portion 820 of the proximal pull tether 742 couples to the elongate shaft of the delivery catheter, specifically the elongate shaft 710 or rail shaft or subassembly. The distal end portion 820 may couple to an insert 734, 734′ as disclosed herein. The proximal end portion of the proximal pull tether 742 engages the pull tether adapter 946. Proximal movement of the pull tether adapter 946 creates height in the elongate shaft 710 or rail shaft or subassembly, and thus the elongate shaft of the delivery system. Distal movement of the pull tether adapter 946 reduces tension and reduces height.

[0242] The first portion 930 is adapted to engage with the second portion 932 such that the first portion 930 rotates with the second portion 932, and the second portion 932 is adapted to disengage from the first portion 930 such that the second portion 932 is rotatable relative to the first portion 930. For example, a capture mechanism 950 (shown in FIG. 83 ) may be utilized to engage the first portion 930 with the second portion 932. The capture mechanism 950 may include a detent or other form of mechanism to hold the first portion 930 in rotational engagement with and enable releasability of the second portion 932. The capture mechanism 950 may be adapted to be overcome with a torque force. FIG. 83 illustrates, for example, a form of capture mechanism 950 including a protrusion 952 on the first portion 930 that engages with a recess 954 in the second portion 932 (alternatively, the first portion 930 may include a recess and the second portion 932 may include the protrusion 952). The protrusion 952 may be deflectable and adapted to disengage from the recess 954 when a sufficient torque force is applied to the capture mechanism 950 .

[0243] Figure 82 shows a cross-sectional view of second portion 932. Figure 83 shows a perspective cross-sectional view of second portion 932. Figure 84 shows a perspective cross-sectional view of second portion 932 and first portion 930. Figure 85 shows a perspective cross-sectional view of second portion 932 from the opposite side of the handle to that shown in Figure 82.

[0244] 86-93 illustrate an exemplary operation of the knob assembly 696. The delivery catheter is shown in FIGS. 86 and 87 in a depth configuration in which the assemblies 20, 24, 26, 28 of the elongate shaft 683 of the delivery catheter 681 are advanced distally relative to the bend 685 created by the elongate shaft 710 or rail shaft or subassembly. The distal end portion 704 of the elongate shaft 683 is shown extending distally, or in a depth position, relative to the bend 685. A corresponding indicator 957 on the handle 682 indicates the depth of the distal end portion 704, with the distal end of the second housing 686 serving as a reference point for the indicator 957.

[0245] 86 and 87 , the knob assembly 696 can be rotated in a first direction to create a depth relative to the bent portion 685 of the distal end portion 704. The knob assembly 696 can be rotated so that the second portion 932 remains engaged with the first portion 930. The internal threads 934 of the first portion 930 drive the threads 936 on the first housing 684 longitudinally relative to the second housing 686 to create the depth variation. The assemblies 20, 24, 26, 28 of the delivery catheter elongate shaft 683 are advanced distally relative to the bent portion 685.

[0246] The knob assembly 696 can be rotated in a second, opposite direction to reduce the depth of the distal end portion 704. For example, with reference to Figures 88 and 89, the knob assembly 696 is rotated in a second direction to slide the first housing 684 proximally relative to the second housing 686. The assemblies 20, 24, 26, 28 of the delivery catheter elongate shaft 683 are retracted proximally relative to the bent portion 685 to reduce the depth.

[0247] 88 and 89, the first portion 930 remains engaged with the second portion 932 due to the coupling of the capture mechanism 950. Thus, rotation of the second portion 932 continues to produce rotation of the first portion 930, which drives the threads 936 on the first housing 684 longitudinally relative to the second housing 686 to reduce the depth.

[0248] Rotation of first portion 930 may continue to a desired point. The desired point may include a defined position of no depth (e.g., a zero point), as represented on indicator 957 in FIG. 88 . In embodiments, rotation of first portion 930 may be set to a desired point where it is desired that independent tension develop in proximal pull tether 742. Such a point may occur before or after the no depth point, as desired. Tension on proximal pull tether 742 deflects proximal slotted portion 726 to create height.

[0249] 90 and 91 , for example, show a configuration in which first portion 930 is prevented from further rotation. The rotational stop can be created in various ways and, in embodiments, can include a stop point in threads 936 on first housing 684. First portion 930 can contact the stop or rotation can be mechanically stopped, but the user can continue to apply a rotational force to second portion 932. The applied torque force overcomes the engagement of capture mechanism 950, which releases first portion 930 from second portion 932. Second portion 932 is adapted to rotate relative to first portion 930 along external threads 937 of first portion 930.

[0250] The second portion 932 can be rotated to increase the spacing between the first portion 930 and the second portion 932. The pull tether adapter 946 is driven proximally relative to the first portion 930 to create tension in the proximal pull tether 742. The second portion 932 slides the adapter 946 proximally relative to the handle 682 to create height. The height of the distal end portion 704 of the elongate shaft 683 increases, as depicted in FIG. 91 . An upward bend is created in the direction opposite to the depth.

[0251] The second portion 932 can be continuously rotated a desired distance independent of the first portion 930. For example, with reference to FIG. 92 , the second portion 932 can be continuously rotated to proximally retract the pull tether adapter 946 and continuously increase the height of the distal end portion 704 of the elongate shaft 683.

[0252] The second portion 932 can be rotated in the opposite direction along the external threads 937 of the first portion 930 to reduce the height. The second portion 932 can be rotated until the second portion 932 re-engages with the first portion 930. The capture mechanism 950 can re-engage. The configuration shown in FIGS. 88 and 89 results.

[0253] Variations in the configuration of the knob assembly 696 may be provided. Figures 94-98, for example, show variations in which the capture mechanism is adapted to be overcome by longitudinal force.

[0254] FIG. 94, for example, shows a variation comprising a knob assembly 960 in which a second portion 962 includes a displacement body 964 or third body adapted to be longitudinally displaced to release a capture mechanism 966.

[0255] A first portion 968 of the knob assembly 960 includes features of the first portion 930 of the knob assembly 696. The first portion 968 comprises a first body of the knob assembly 960. The second portion 962 of the knob assembly 960 includes an outer body 970, or second body, of the knob assembly 960 and a displacement body 964. The outer body 970 encloses a cavity 972 for longitudinal displacement of the displacement body 964 therein.

[0256] The displacement body 964 includes an alignment feature 974 that rotationally aligns the displacement body 964 with the outer body 970. The alignment feature 974 comprises, for example, a tab (shown in FIG. 96 ) adapted to slide longitudinally within a slot 976 on the inner surface of the outer body 970.

[0257] The capture mechanism 966 may include ratchet surfaces 980 or friction surfaces on the displacement body 964 and the first portion 968, and a spring body 982 that urges the ratchet surfaces 980 into longitudinal engagement with one another. The force of the spring body 982 is adapted to be overcome by a longitudinal force to release the ratchet surfaces 980 from one another.

[0258] The displacement body 964 includes a fixed rotational coupling 984 with the pull tether adapter 946 .

[0259] 95 shows a cross-sectional view of the knob assembly 960 on the handle 682. The first housing 684 includes a stop 986 adapted to contact the pull tether adapter 946 upon proximal movement of the first housing 684 relative to the pull tether adapter 946.

[0260] In use, the spring body 982 urges the ratchet surfaces 980 together such that the outer body 970 rotates with the first portion 968. Thus, as the outer body 970 rotates, the first portion 968 rotates, and accordingly, the first housing 684 is driven relative to the second housing 686 to change the desired depth.

[0261] At a defined point of depth reduction (e.g., proximal movement of first housing 684), stop 986 contacts and presses against pull tether adapter 946 with a proximal longitudinal force to overcome the force of spring body 982. Thus, capture mechanism 966 is released and outer body 970 can rotate and move proximally independent of first portion 968. FIG. 97, for example, illustrates the displacement of displacement body 964 within cavity 972 of outer body 970.

[0262] The outer body 970 rotates about the external threads 983 of the first portion 968 to drive the pull tether adapter 946 proximally. A height (as depicted in FIGS. 90-93) is created due to the proximal retraction of the pull tether adapter 946. FIG. 98 illustrates the proximal movement of the outer body 970 relative to the first portion 968 to retract the pull tether adapter 946. At a desired point, the outer body 970 can be rotated in the opposite direction to reduce the height and re-engage the capture mechanism 966. The resulting configuration is as shown in FIG. 95.

[0263] Variations in the configuration of the knob assembly 696 may be provided. Figures 99-104 show a variation in which a pull tether adapter 990 includes a threaded portion 992 for engaging a threaded portion 994 (shown in Figure 100) of the knob assembly 996.

[0264] FIG. 99 shows a perspective view of the pull tether adapter 990. The pull tether adapter 990 is shaped so that the threaded portion 992 extends into a cutout or slot 998 (shown in FIG. 100) in the first housing 684. The pull tether adapter 990 has an oval shape, with the threaded portion 992 positioned on a protruding end 1000 of the pull tether adapter 990. The threaded portion 992 is positioned to be engaged by a threaded portion 994 of the knob assembly 996.

[0265] 100, the pull tether adapter 990 is shown in an interior cavity 1002 of the handle. The threads 992 extend into a slot 998. The first housing 684 includes stops 1004, 1006 that comprise the ends of the slot 998 that are adapted to contact and move against the pull tether adapter 990 at a desired point.

[0266] The knob assembly 996 is shown in FIG. 100 with a fixed rotational connection 1008 to the second housing 686 and a threaded connection with the threaded portion 936 of the first housing 684. The knob assembly 996 is axially fixed relative to the second housing 686.

[0267] The threaded engagement between the threaded portion 994 of the knob assembly 996 and the threaded portion 936 of the first housing 684 allows the knob assembly 996 to rotate and advance or retract the first housing 684 relative to the second housing 686 (thereby changing the depth of the distal end portion of the delivery catheter). In the configuration shown in FIG. 100 , the knob assembly 996 is only threadably engaged with the first housing 684, thereby allowing the knob assembly 996 to rotate and advance or retract the first housing 684. Upon retraction, a stop 1004 at the distal end of the slot 998 pushes the pull tether adapter 990, along with the first housing 684, proximally.

[0268] At a desired point, threads 994 of knob assembly 996 engage threads 992 of pull tether adapter 990 when pull tether adapter 990 is retracted proximally. FIG. 101 , for example, illustrates engagement of both threads 992 of pull tether adapter 990 and threads 936 of first housing 684 by knob assembly 996. Pull tether adapter 990 can be retracted proximally along with first housing 684. In an embodiment, the thread pitch of pull tether adapter 990 is the same as the thread pitch of first housing 684.

[0269] The threads 936 of the first housing 684 stop at a distal position 1010. The knob assembly 996 may continue to engage with both the threads 992 of the pull tether adapter 990 and the threads 936 of the first housing 684 until the first housing 684 retracts proximally a distance at which the threads 994 disengage from the threads 936 of the first housing 684. FIG. 102 shows the position before the threads 994 disengage from the threads 936 of the first housing 684.

[0270] FIG. 103 shows that the knob assembly 996 has disengaged from the threaded portion 936 of the first housing 684. The threaded portion 994 of the knob assembly 996 has moved to a distal position 1010 of the housing 684 lacking threads. The knob assembly 996 continues to engage the pull tether adapter 990, retracting the pull tether adapter 990 relative to the first housing 684. A height (as depicted in FIGS. 90-93) is created due to the proximal retraction of the pull tether adapter 990. Thus, the knob assembly 996 is adapted to alternately engage the threaded portion 936 of the first housing 684 and the threaded portion 992 of the pull 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 allow the pull tether adapter 990 to slide relative to the first housing 684 .

[0271] The pull tether adapter 990 may continue to retract to a desired point. To reduce the height, the knob assembly 996 may be rotated in the opposite direction. The pull tether adapter 990 may be advanced distally until it reaches a stop 1004. The pull tether adapter 990 may 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 with the threads 994 of the knob assembly 996.

[0272] The knob assembly 996 may return to the configuration shown in FIG. 102. The knob assembly 996 may continue to rotate to create depth, for example, as depicted in FIG. 104. Variations in the configuration of the knob assembly may be provided in embodiments. In embodiments, a decoupling mechanism, such as a spring or magnet, may be utilized to position the pull tether adapter 990 before the stop 1004 pushes the pull tether adapter 990 proximally. The decoupling mechanism may be overcome by the stop 1004 pushing the pull tether adapter 990 proximally.

[0273] The knob assembly may advantageously allow a single knob assembly to manipulate both the depth and height of the elongate shaft of the delivery catheter. A user may easily rotate in a first direction to create depth and rotate in the opposite direction to reduce depth and create height. Intuitive control of depth and height may result. Additional knobs may not be required to separately change depth and height. Furthermore, the location or timing at which height is created may be controlled utilizing the knob assemblies disclosed herein. The location or timing of the release of the capture mechanism or sliding action of the pull tether adapter relative to the housing may be set to create a desired point at which height occurs. Improved control of the implant deployment procedure may be created.

[0274] Any of the features of Figures 86-104 may be utilized alone or in combination with each other or any other embodiment disclosed herein.

[0275] 105 shows a perspective cross-sectional view of the proximal end portion of the handle 682. The mid-shaft adapter 136 is coupled to the first housing 684 and is fixed in position relative to the first housing 684. Thus, the mid-shaft or mid-shaft subassembly 24 moves with the movement of the first housing 684.

[0276] The coupled tether adapter 150 is coupled to a coupled tether actuator 698 in the form of a control knob. The coupled tether actuator 698 has a threaded connection to the first housing 684 and a fixed rotational connection to the coupled tether adapter 150. Rotating the coupled tether actuator 698 about the first housing 684 moves the coupled tether adapter 150 proximally or distally, which may be relative to the midshaft or midshaft subassembly 24 or other shaft or sheath of the delivery system 680, as desired. Expansion of the implant may be controlled by advancing (expanding) or retracting (retracting) the coupled tether actuator 698 and coupled tether adapter 150 along the elongate shaft of the delivery catheter. Advancement may expand the implant relative to the distal pusher 138 of the midshaft or midshaft subassembly 24, and retraction may retract the implant into the distal pusher 138 of the midshaft or midshaft subassembly 24.

[0277] The retraction portion 192 or proximal end portion of the release assembly or subassembly 28 may be coupled to a release actuator 700 in the form of a control knob 701 (shown in FIG. 64). The control knob 701 may engage the retraction portion 192 of the release assembly or subassembly 28 by a threaded connection to a ratchet mechanism 705. The ratchet mechanism 705 may allow for small, incremental rotations of the control knob 701 to gradually retract the release assembly or subassembly 28. The incremental rotations may allow for controlled release of the implant from the delivery system through the incremental retraction of the release assembly or subassembly 28. The release tether of the release assembly or subassembly 28 retracts from the loop portion of the tether assembly. Thus, a physician or technician can confirm proper placement of the implant by the gradual retraction of the release assembly or subassembly 28, if desired. Other configurations may be utilized in embodiments.

[0278] In operation, the delivery catheter 681 may be advanced into the patient's vascular system utilizing an access method disclosed herein (e.g., transfemoral, transcervical, etc.). Access as shown in FIG. 26 (e.g., transfemoral and percutaneous) may also be utilized. Once advanced, the delivery catheter 681 may access the right atrium via the inferior vena cava. Access via the superior vena cava may be utilized in some embodiments.

[0279] The rail shaft or subassembly disclosed herein may be utilized to deflect the elongate shaft or shaft assembly 683 of the delivery catheter 681. Depth and / or height may be provided using the mechanisms disclosed herein upon approaching the implantation site. The depth and / or height changes may enable navigation and adjustment of structures within the vasculature. For example, height may enable enhanced alignment of the delivery catheter with the annulus of the native tricuspid valve. Height may be generated within the right atrium to aid in navigating the geometry of the right atrium. Various other deflections of the delivery catheter 681 may be utilized to position the delivery catheter in a desired orientation.

[0280] The distal tip of the delivery catheter 681 can be deflected to align approximately perpendicular with the implantation site, for example, as depicted in Figure 27. The depth of the distal tip or distal end portion can be increased using methods disclosed herein to position the distal tip at the tricuspid valve annulus (or, in a mitral valve implant, the mitral valve annulus).

[0281] At a desired point, the outer sheath shaft or subassembly may be retracted to at least partially expose a portion of the implant for deployment. The capsule of the outer sheath shaft or subassembly may be retracted. Ejection of the implant from the capsule occurs. FIG. 28, for example, shows a representative configuration. The proximal end portion of the implant may be retained within the distal pusher 138 of the midshaft or midshaft subassembly at this point. The distal or ventricular anchor of the implant may be deployed to capture the leaflets of the native valve, for example, as shown in FIG. 28. Imaging (e.g., ultrasound and / or fluoroscopy) may be utilized to determine whether capture has occurred. Deployment may continue upon visualization of leaflet capture.

[0282] To generate further expansion of the implant, the coupling tether actuator 698 can be actuated, causing the coupling tether 142 to expand for expansion of the implant. Figures 18 and 29 show representative configurations. Imaging can confirm the desired placement of the implant.

[0283] Once it has been confirmed that the implant is in the desired position (e.g., the ventricular anchors or hook anchors are anchored to the native valve leaflets and the implant is seated in the desired position within the valve annulus), release actuator 700 can be actuated. Thus, the implant can be ejected from the capsule while attached to the tether assembly (connected tether 142), and then released from the tether assembly after confirming proper placement in the native valve (e.g., the native atrioventricular valve).

[0284] Before the release actuator 700 is actuated, the implant can be recaptured by retracting the attachment tether 142. Thus, if the position of the implant is undesired during the deployment process, the attachment tether 142 can be retracted. The implant can be retracted back into the distal pusher 138 of the midshaft or midshaft subassembly, as desired. Repositioning of the implant occurs, after which re-release of the implant may be provided, or the deployment sequence may be aborted entirely.

[0285] Upon confirming proper placement, the release assembly or subassembly 28 may be retracted to release the implant from the delivery system. Configurations such as those shown in FIGS. 23 and 30 may result. The delivery system may be withdrawn, leaving the implant in place. FIG. 31, for example, shows a representative configuration. Other methods, systems, or devices may be utilized as desired. Methods may vary as desired. Other methods and features of the delivery system may be disclosed in International Application No. PCT / US2022 / 016150, entitled "Delivery Systems for Replacement Heart Valves," filed February 11, 2022, and published August 18, 2022 as International Publication No. WO2022 / 174057, the entire contents of which are incorporated herein by reference for all purposes.

[0286] An internal guidewire lumen or sheath may further be provided, as desired. Figure 106, for example, shows a side view of a guidewire lumen or sheath 1020. The guidewire sheath 1020 includes a shaft 1022 having an internal lumen 1024 for passage of a guidewire therethrough (shown in cross section in Figure 107). The internal lumen 1024 may extend to a tip 1026 of a nose body 1028 positioned at the distal end of the shaft 1022. The nose body 1028 may include a cone as shown in Figures 106 and 107, or may have another configuration, as desired.

[0287] Nose body 1028 may comprise the distal portion of a delivery catheter that passes through the vascular system of a patient's body.

[0288] In an embodiment, a guidewire 1030 (shown in FIG. 107) may be first advanced to the implantation site (e.g., placed in a ventricle or other portion of the heart), and a delivery catheter may extend to the implantation site along the guidewire 1030. The guidewire sheath 1020 slides along the guidewire 1030 (with the guidewire 1030 positioned within the internal lumen 1024) as the delivery catheter is advanced.

[0289] At some point during the procedure, it may be desirable to retract the guidewire 1030 proximally into the tip 1026 of the nose body 1028, such that the tip 1032 of the guidewire 1030 is within or adjacent to the distal end 1034 of the guidewire sheath 1020. Such a mechanism may be utilized when it is desirable to move or deflect the delivery catheter without interference from the guidewire 1030 protruding from the distal end 1034 of the guidewire sheath 1020.

[0290] A potential problem with retracting the guidewire 1030 into or near the tip 1026 is subsequent advancement or distal movement of the guidewire 1030. The diameter 1036 of the internal lumen 1024 of the shaft 1022 may narrow toward or be close to the diameter of the guidewire 1030. Thus, because the internal lumen 1024 of the shaft 1022 restricts the guidewire 1030 to the longitudinal or axial shape of the internal lumen 1024, advancement or distal movement of the guidewire 1030 relative to the distal end 1034 of the guidewire sheath 1020 may create an inflexible tip 1032 of the guidewire 1030. Thus, the guidewire 1030 (as shown by the dashed lines in FIG. 107 ) may protrude with the inflexible tip 1032, which may puncture or otherwise damage surrounding tissue 1038 upon advancement of the guidewire 1030.

[0291] 108-117 illustrate embodiments intended to address the issue of advancement or distal migration of a guidewire 1030. FIG. 108, for example, illustrates a cross-sectional view of a guidewire sheath 1040 having a proximal end portion 1042 and a distal end 1044, and an internal lumen 1046 for passage of a guidewire 1030 therethrough. The internal lumen 1046 has a diameter 1048. The internal lumen 1046 is adapted for distal advancement or proximal retraction of the guidewire 1030.

[0292] The spacer body 1050 is positioned at the distal end 1044 of the guidewire sheath 1040. The spacer body 1050 includes an opening 1052 for the guidewire 1030 to protrude therethrough.

[0293] The spacer body 1050 has a cavity 1054 with a diameter 1056 that is larger than the diameter 1048 of the internal lumen 1046 of the guidewire sheath 1040. The cavity 1054 is bounded by an outer wall 1058 of the spacer body 1050, and an opening 1052 is positioned distal to an opening 1060 in the spacer body 1050 for entry of the guidewire 1030 into the cavity 1054. The opening 1060 may be continuous with the internal lumen 1046 of the guidewire sheath 1040 such that the guidewire 1030 passes from the internal lumen 1046 to the cavity 1054 through the opening 1060. The opening 1052 is positioned at a distal end 1062 of the spacer body 1050. The distal end 1062 may include a contact surface 1064 for abutting a surface such as tissue located around the implantation site (e.g., heart wall tissue, chordae tendineae, valve leaflets, or other tissue). The spacer body 1050 may have a variety of shapes as desired, such as the dome shape shown in FIGS. 108-115, or the cone shape shown in FIGS. 116 and 117, among other shapes as desired (e.g., cubic, rectangular, triangular, among others).

[0294] 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 guidewire sheath 1040 .

[0295] Cavity 1054 may have a variety of shapes, including the dome shape shown in FIGS. 108-113, or other shapes (e.g., conical, rectangular, oval, among others). A diameter 1056 of cavity 1054 that is larger than a diameter 1048 of internal lumen 1046 of guidewire sheath 1040 allows guidewire 1030 to deflect within cavity 1054. Deflection may be lateral deflection, as depicted in FIG. 109. Thus, restriction of the distal end or tip 1032 of guidewire 1030 by internal lumen 1024 may be eliminated.

[0296] 109 shows a cross-sectional view of an exemplary operation of the spacer body 1050. The distal end 1062 or contact surface 1064 of the spacer body 1050 may contact or be proximate to the tissue 1038. The guidewire 1030 may be advanced distally through the internal lumen 1046. The tip 1032 of the guidewire 1030 may deflect or buckle laterally within the cavity 1054 upon contact with the tissue 1038 so that the tip 1032 of the guidewire 1030 does not puncture or otherwise damage the tissue 1038. The distal end 1062 or contact surface 1064 may move back or be spaced away from the surface of the tissue 1038 so that the tip 1032 of the guidewire 1030 may slide laterally along the surface of the tissue 1038 and avoid puncturing the tissue 1038. Thus, a reduced likelihood of puncture or damage may result. A similar result occurs when the distal end 1062 or contact surface 1064 is spaced from the surface of the tissue 1038 and the guidewire 1030 is advanced to contact the tissue 1038. The cavity 1054 provides space for deflection.

[0297] 110 shows a side perspective view of the shaft 1068 of the guidewire sheath 1040 coupled to the spacer body 1050. The spacer body 1050 may comprise the nose body of the delivery catheter, including the distal portion or tip of the delivery catheter. The shaft 1068 of the guidewire sheath 1040 may extend proximally along the elongate shaft of the delivery catheter and through the handle of the delivery catheter.

[0298] Variations in the configuration of the spacer body 1050 may be provided. Fig. 111, for example, shows a variation in which the spacer body 1070 includes a ridge 1072 that extends radially inward toward the cavity 1074. The ridge 1072 may assist the guidewire 1030 in deflecting laterally by providing a laterally extending surface within the cavity 1074 for the guidewire 1030 to rest against.

[0299] Figure 112 shows a variation in which a sheath 1080 surrounds the shaft 1068 of the guidewire sheath 1040 and abuts the spacer body 1050. The sheath 1080 can stabilize the spacer body 1050 from lateral deflection. Figure 113 shows a side view of such a configuration.

[0300] 114 shows a variation in which the spacer body 1090 includes a plurality of openings 1092 for the guidewires to protrude therethrough. The spacer body 1090 may include at least one rib 1094 separating the plurality of openings 1092.

[0301] In an embodiment, one or more of the openings 1092 may be positioned on a sidewall 1096 of the spacer body 1090. The sidewall 1096 may extend distally to a distal end 1098 of the spacer body 1090. The guidewire 1030 may protrude laterally from the openings 1092, allowing for lateral exit of the guidewire 1030 from the spacer body 1090, further reducing the possibility of tissue puncture or other damage from axial advancement of the guidewire 1030. FIG. 115 shows an end view of the spacer body 1090 shown in FIG. 114.

[0302] FIG. 116 shows a variation in which the distal end 1100 of the spacer body 1102 comprises a conical tip and openings 1104 are on the sidewall 1106 of the spacer body 1102. The guidewire 1030 exits laterally from the spacer body 1102. FIG. 117 shows a variation in which multiple openings 1110 are provided along the conical spacer body 1112 for lateral exit of the guidewire 1030. The openings 1110 may be separated by ribs 1114.

[0303] Further variations in the configuration of the spacer body may be provided in the embodiments. Additionally, it will be understood that any of the features of Figures 106-117 may be utilized alone or in combination with each other or any other embodiment disclosed herein.

[0304] The sheath or shaft or assembly of the delivery catheter 681 may be arranged as shown in the transverse cross section of FIG. 118. The guidewire sheath 1040 or nosecone shaft or subassembly may comprise the innermost sheath or layer, with the release assembly or subassembly 28 extending adjacent to the guidewire sheath 1040. The tether assembly or subassembly 26 may extend adjacent to the guidewire sheath 1040. The midshaft or midshaft subassembly 24 may surround such an inner assembly. The rail shaft or subassembly or elongate shaft 710 may surround the midshaft or midshaft subassembly 24. The outer sheath shaft or subassembly 20 may surround the rail shaft or subassembly or elongate shaft 710. Other configurations of sheaths or shafts or assemblies disclosed herein may be utilized in the configuration shown in FIG. 118. Variations in the ordering of the sheaths or shafts or assemblies may be provided.

[0305] Figure 119, for example, illustrates a variation on the configuration shown in Figures 60A-61. A flexible retaining tether 658 surrounds the guidewire sheath 1040 or nosecone shaft or subassembly. The release assembly or subassembly 28 extends externally of (or, in some embodiments, may extend internally of) the flexible retaining tether 658. Other configurations may be utilized in some embodiments.

[0306] Figure 120 illustrates a configuration of a stabilizer assembly 1120 for a delivery catheter that may be utilized in embodiments herein. A delivery catheter 681 may be stabilized on the stabilizer assembly 1120, for example, in the configuration shown in Figure 62. The stabilizer is intended to mate with the handle of the delivery catheter to stabilize the delivery catheter during deployment of the prosthetic heart valve into the native valve (e.g., the native atrioventricular valve).

[0307] 121-123 show exemplary prosthetic valves that may be implanted within the body using the delivery systems and / or mechanisms described herein. Further details of implants or prosthetic valves that may be utilized are disclosed in U.S. Provisional Patent Application No. 63 / 436,051, filed December 29, 2022, and U.S. Provisional Patent Application No. 63 / 533,458, filed August 18, 2023, the entire contents of each of which are incorporated herein by reference.

[0308] 121 shows a perspective view of a prosthetic valve 1280 that may be utilized in the embodiments herein. The prosthetic valve 1280 may include features of any other prosthetic valve or embodiment disclosed herein.

[0309] The prosthetic valve 1280 includes one or more prosthetic valve leaflets 1282. The prosthetic valve leaflets 1282 may be positioned within a flow channel 1284 of the prosthetic valve 1280. The prosthetic valve leaflets 1282 may be supported by a valve body 1286 and extend radially inward from the valve body 1286 within the flow channel 1284. The prosthetic valve leaflets 1282 are disposed within the lumen of the valve body 1286 to allow unidirectional flow.

[0310] The valve body 1286 may include an inner body 1288 (shown in FIG. 122 ) and an outer body 1290. The inner body 1288 and / or outer body 1290 preferably take the form of a collapsible and re-expandable metal frame. Each frame may comprise a self-expanding frame, which may be made of a shape-memory material (e.g., nitinol). The inner body 1288 may include features of other embodiments of the inner body disclosed herein unless otherwise noted. The inner body 1288 may include an inner frame 1292 (shown in FIG. 123 ). The inner frame 1292 supports the leaflets 1282 of the prosthetic valve. The inner frame 1292 may include a plurality of struts, which may be separated by spaces or openings. The struts are preferably arranged to form rows of connected cells.

[0311] The outer body 1290 may include a seal and may include an outer frame 1306 (shown in FIG. 123 ) and a sealing skirt 1308, an outer skirt, or a woven skirt positioned on the outer frame 1306. The outer frame 1306 is positioned radially outward of the inner frame 1292. An outer surface 1307 of the outer frame 1306 faces radially outward from the prosthetic valve 1280. The outer surface 1307 is for pressing against the tissue of the native heart valve. The sealing skirt 1308 extends along the outer surface 1307 of the outer frame 1306.

[0312] The proximal end portion 1314 of the outer frame 1306 may be coupled to the proximal end portion 1299 of the inner frame 1292 .

[0313] In some embodiments, the outer frame 1306 has a tapered shape such that a downstream or distal end portion 1316 has a smaller diameter than an intermediate portion 1322 of the outer frame 1306. The intermediate portion 1322 may have a diameter ranging from about 35 millimeters to about 60 millimeters, for example, with the distal end portion 1316 having the smaller diameter.

[0314] The outer frame 1306 may include one or more gripping features 1173 (shown in FIG. 121 ) disposed along its outer surface. Features of the gripping features are disclosed in U.S. Provisional Patent Application No. 63 / 436,051, filed December 29, 2022, and U.S. Provisional Patent Application No. 63 / 533,458, filed August 18, 2023, the entire contents of each of which are incorporated herein by reference. The gripping 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.

[0315] The anchors 1304 are shaped to be placed behind the native valve leaflets. The anchors may be formed in a hook shape or may be hook arm anchors or ventricular anchors. The anchors 1304 may include any other anchor features disclosed herein. The anchors 1304 may be coupled to the distal end portion 1300 of the inner frame 1292. The anchors 1304 are adapted to overhang (or extend around) the native valve leaflets to help anchor the prosthetic valve within the native valve. The capsule of the delivery system may be retracted to allow the anchors 1304 to rotate into position and press the native valve leaflets against the outer frame 1306.

[0316] The outer frame 1306 may include one or more couplers 1399 in the form of eyelets or suture eyelets for coupling with a coupling tether, as disclosed herein. The coupling tether may pass through the suture eyelets, for example, in the configurations shown in FIGS. 18 and 20. Nine couplers 1399 are described in the examples, although a greater or lesser number may be utilized as desired. The couplers 1399 may be positioned at the inlet end portion of the prosthetic valve 1280. The couplers 1399 may be positioned on strut arm ends or tabs on the frame of the prosthetic valve 1280.

[0317] 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, in some embodiments, made of a shape-memory material (e.g., nitinol). Other materials can be used in some embodiments. The prosthetic valve 1280 can be adapted to be constrained in a compressed configuration and then released to self-expand at the implantation site.

[0318] Examples of prosthetic valves may be utilized in the tricuspid valve as disclosed herein, or in other deployment locations, such as the native mitral valve, or other deployment locations. Deployment in the aortic or pulmonary valve, or other implantation sites, is also envisioned and considered within the scope of this disclosure.

[0319] The delivery systems disclosed herein may be utilized in any of the embodiments disclosed herein.

[0320] Various variations of the embodiments disclosed herein may be provided. Features of the embodiments may be modified, substituted, omitted, or combined between embodiments as desired. Combinations of features between embodiments may be provided as desired. Combinations of features may be provided between embodiments with other features of those embodiments omitted as desired.

[0321] The various embodiments of the sealing skirt disclosed herein may have a variety of configurations, including fabric skirts, foam skirts, or braided skirts, as desired. A variety of materials may be utilized, as desired.

[0322] The implants disclosed herein may include prosthetic heart valves or other forms of implants such as stents or filters, among other things, diagnostic devices. The implant may be an expandable implant configured to move from a compressed or undeployed state to an expanded or deployed state. The implant may be a compressible implant configured to be compressed inward to have a reduced profile, moving the implant to the compressed or undeployed state.

[0323] Various forms of delivery devices may be utilized in the embodiments disclosed herein. The delivery devices disclosed herein may also be utilized in the replacement and repair of aortic, mitral, tricuspid, and pulmonary valves. Delivery devices may include other forms of implants, such as stents or filters, or delivery devices for delivering diagnostic devices, among others.

[0324] The implants and systems disclosed herein can be used in transcatheter mitral or tricuspid valve implantation, as well as in transcatheter aortic valve replacement (TAVR) or replacement of other native heart valves (e.g., pulmonary valves). The delivery devices and systems disclosed herein can be utilized 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, in which a delivery catheter is advanced into the right atrium, through a hole in the septum, and then into the left atrium to access the native mitral valve. The delivery devices and systems can also be utilized in other transcatheter percutaneous procedures, including transarterial procedures, which can be transfemoral or transcarotid. Notably, transapical procedures can also be utilized. Other procedures can be utilized as desired.

[0325] Additionally, the methods herein are not limited to those specifically described, but may include methods utilizing the systems and devices disclosed herein. Method steps may be modified, omitted, or added in accordance with the systems, devices, and methods disclosed herein. Examples disclosed herein may include, in some embodiments, systems for implantation within the human body.

[0326] For purposes of this specification, certain aspects, advantages, and novel features of the disclosed embodiments are described herein. The disclosed methods, apparatus, and systems should not be construed as limiting in any manner. Instead, the present disclosure covers all novel and non-obvious features and aspects of the various disclosed embodiments in various combinations and subcombinations with each other. The methods, apparatus, and systems are not limited to any particular aspect or feature or combination thereof, nor are the disclosed embodiments required to exhibit any one or more particular advantages or solve any problems. Features, elements, or combinations of one embodiment can be combined in other embodiments herein. [Example]

[0327] Example 1: A delivery system for an implant, comprising an elongate shaft including a proximal end portion and a distal end portion for advancing the implant to an implantation site, at least a portion of the elongate shaft comprising a tether assembly including a plurality of connecting tethers configured to connect to the implant, a tether manifold for connecting to the plurality of connecting tethers, and a flexible retaining tether coupled to the tether manifold and extending proximally from the tether manifold.

[0328] Example 2: The delivery system of any embodiment herein, particularly embodiment 1, wherein the flexible retaining tether comprises one or more of a wire or a suture.

[0329] Example 3: The delivery system of any of the embodiments herein, particularly Example 1 or Example 2, wherein each of the connecting tethers comprises a suture.

[0330] Example 4: The delivery system of any of the embodiments herein, particularly embodiments 1-3, wherein each of the connecting tethers comprises a loop configured to pass through an opening in a portion of the implant.

[0331] Example 5: The delivery system of any of the embodiments herein, particularly embodiments 1-4, wherein the plurality of connecting tethers comprises a continuous suture.

[0332] Example 6: The delivery system described in any example herein, particularly Example 5, wherein the continuous suture is looped with a tether manifold to form multiple linked tethers.

[0333] Example 7: The delivery system of any of the Examples herein, particularly Examples 1-6, wherein the multiple linking tethers are woven or braided in a tether manifold.

[0334] Example 8: The delivery system of any of the Examples herein, particularly Examples 1-7, wherein the flexible retaining tether is woven or braided.

[0335] Example 9: The delivery system of any of the embodiments herein, particularly embodiments 1-8, wherein at least one of the plurality of connecting tethers comprises a free end embedded within a tether manifold or flexible retaining tether.

[0336] Example 10: The delivery system of any example herein, particularly Example 9, wherein the free end is anchored to a tether manifold or a flexible retaining tether.

[0337] Example 11: The delivery system of any of the embodiments herein, particularly embodiments 1-10, wherein at least one of the plurality of connecting tethers comprises a woven or braided ring.

[0338] Example 12: The delivery system of any example herein, particularly Example 11, wherein at least a portion of the tether manifold overlaps with the woven or braided ring to couple the woven or braided ring to the tether manifold.

[0339] Example 13: The delivery system described in any of the examples herein, particularly Example 11 or Example 12, wherein the woven or braided ring extends from the tether manifold and forms at least two loops, each loop configured to couple to an implant.

[0340] Example 14: The delivery system described in any of the Examples herein, particularly Examples 1-13, wherein the tether manifold comprises warp yarns woven with weft yarns, and the plurality of connecting tethers comprises a continuation of the warp yarns of the tether manifold devoid of weaving with any weft yarns.

[0341] Example 15: The delivery system of any example herein, particularly example 14, wherein each of the plurality of connecting tethers comprises a continuous loop of warp thread.

[0342] Example 16: The delivery system of any example herein, particularly Example 14 or Example 15, wherein the tethered manifold comprises a vertical stack and a horizontal stack of warp yarns.

[0343] Example 17: The delivery system of any of the embodiments herein, particularly embodiments 1-16, wherein each of the plurality of connecting tethers comprises a loop of thread, and the tether manifold comprises a weave or braid of threads of the plurality of connecting tethers.

[0344] Example 18: The delivery system described in any example herein, particularly Example 17, wherein the flexible retaining tether comprises a weave or braid of multiple connected tether threads, and the flexible retaining tether comprises a proximal end portion comprising free ends of the multiple connected tether threads.

[0345] Example 19: The delivery system of any of the Examples herein, particularly Examples 1-18, further comprising a release assembly for releasing the plurality of attached tethers from the implant.

[0346] Example 20: The delivery system of any of the embodiments herein, particularly embodiments 1-19, wherein the elongate shaft comprises a sheath extending over the flexible retaining tether.

[0347] Example 21: The delivery system of any of the embodiments herein, particularly embodiments 1-20, wherein the tether manifold is positioned at the distal end portion and the flexible retaining tether extends proximally from the distal end portion to the proximal end portion.

[0348] Example 22: The delivery system of any of the embodiments herein, particularly embodiments 1-21, wherein the proximal end portion comprises a housing for the elongate shaft.

[0349] Example 23: The delivery system of any of the embodiments herein, particularly embodiments 1-22, wherein the elongate shaft comprises a deflectable portion configured to deflect transversely relative to the longitudinal axis of the elongate shaft.

[0350] Example 24: The delivery system of any example herein, particularly example 23, wherein the flexible retaining tether is configured to deflect at the deflectable portion.

[0351] Example 25: The delivery system of any example herein, particularly example 23 or example 24, further comprising a control mechanism for controlling the deflection of the deflectable portion.

[0352] Example 26: The delivery system of any of the embodiments herein, particularly embodiments 1-25, wherein the elongate shaft comprises a capsule for holding the implant.

[0353] Example 27: The delivery system of any example herein, particularly example 26, further comprising a retraction mechanism for retracting the capsule to release the implant from the capsule.

[0354] Example 28: The delivery system of any of the Examples herein, particularly Examples 1-27, further comprising an implant, wherein the implant comprises a prosthetic heart valve.

[0355] Example 29: The delivery system described in any embodiment herein, particularly embodiment 28, wherein the prosthetic heart valve includes a plurality of eyelets, and each of the connecting tethers is configured to pass through a respective one of the plurality of eyelets.

[0356] Example 30: The delivery system of any of the Examples herein, particularly Examples 1-29, wherein the flexible retaining tether comprises an internal lumen for the nosecone shaft to extend therethrough.

[0357] Example 31: A method comprising: delivering an implant to a native heart valve utilizing a delivery system; the delivery system comprising an elongate shaft including a proximal end portion and a distal end portion for advancing the implant to the native heart valve; at least a portion of the elongate shaft comprising a tether assembly including a plurality of coupling tethers configured to couple to the implant; a tether manifold for coupling to the plurality of coupling tethers; and a flexible retaining tether coupled to the tether manifold and extending proximally from the tether manifold.

[0358] Example 32: The method of any embodiment herein, particularly embodiment 31, wherein the flexible retaining tether comprises one or more of a wire or a suture.

[0359] Example 33: The method of any of the embodiments herein, particularly embodiment 31 or embodiment 32, wherein each of the connecting tethers comprises a suture.

[0360] Example 34: The method of any of the embodiments herein, particularly embodiments 31-33, wherein each of the attached tethers comprises a loop configured to pass through an opening in a portion of the implant.

[0361] Example 35: The method of any of the embodiments herein, particularly embodiments 31-34, wherein the plurality of connected tethers comprises a running suture.

[0362] Example 36: The method of any of the embodiments herein, particularly embodiments 31-35, wherein at least one of the plurality of connecting tethers comprises a free end embedded within a tether manifold or flexible retaining tether.

[0363] Example 37: The method of any example herein, particularly example 36, wherein the free end is anchored to a tether manifold or a flexible retaining tether.

[0364] Example 38: The method of any of the embodiments herein, particularly embodiments 31-37, wherein at least one attachment tether comprises a woven or braided ring.

[0365] Example 39: The method of any example herein, particularly example 38, wherein at least a portion of the tether manifold overlaps with the woven or braided ring to couple the woven or braided ring to the tether manifold.

[0366] Example 40: The method of any of the embodiments herein, particularly embodiment 38 or embodiment 39, wherein the woven or braided ring extends from the tether manifold and forms at least two loops, each loop configured to couple to an implant.

[0367] Example 41: The method of any of the embodiments herein, particularly embodiments 31-40, wherein the tether manifold comprises warp yarns woven with weft yarns, and the plurality of bonded tethers comprises a continuation of the warp yarns of the tether manifold devoid of weaving with any weft yarns.

[0368] Example 42: The method of any embodiment herein, particularly embodiment 41, wherein each of the plurality of connecting tethers comprises a continuous loop of warp yarn.

[0369] Example 43: The method of any example herein, particularly example 41 or example 42, wherein the tether manifold comprises a vertical stack and a horizontal stack of warp yarns.

[0370] Example 44: The method of any of the embodiments herein, particularly embodiments 31-43, wherein each of the plurality of connecting tethers comprises a loop of thread, and the tether manifold comprises a weave or braid of threads of the plurality of connecting tethers.

[0371] Example 45: The method of any of the examples herein, particularly Example 44, wherein the flexible retaining tether comprises a weave or braid of multiple connected tether threads, and the flexible retaining tether comprises a proximal end portion comprising free ends of the multiple connected tether threads.

[0372] Example 46: A delivery system for an implant comprising: an elongate shaft having a proximal end portion and a distal end portion for advancing the implant to an implantation site; at least a portion of the elongate shaft comprising a tether assembly and a release assembly; the tether assembly comprising one or more attachment tethers configured to attach to the implant, each attachment tether comprising a loop portion configured to protrude from a respective opening in a portion of the implant; the release assembly comprising one or more release tethers configured to extend through one or more of the loop portions to retain the implant in the one or more loop portions, the one or more release tethers configured to be retracted from the one or more loop portions to release the implant from the one or more loop portions.

[0373] Example 47: The delivery system of any example herein, particularly Example 46, wherein each release tether extends through multiple loop portions.

[0374] Example 48: The delivery system of any of the examples herein, particularly Example 46 or Example 47, wherein each release tether extends through at least three of the loop portions.

[0375] Example 49: The delivery system of any of the Examples herein, particularly Examples 46-48, wherein the one or more release tethers include at least three of the release tethers.

[0376] Example 50: The delivery system of any of the examples herein, particularly examples 46-49, wherein the one or more release tethers extend circumferentially between the plurality of loop portions.

[0377] Example 51: The delivery system of any of the embodiments herein, particularly embodiments 46-50, wherein the one or more release tethers extend radially inwardly into the retaining sheath of the release assembly.

[0378] Example 52: The delivery system of any of the embodiments herein, particularly embodiments 46-51, wherein the elongate shaft comprises a sheath extending over at least a portion of the tether assembly.

[0379] Example 53: The delivery system of any of the embodiments herein, particularly embodiments 46-52, wherein the elongate shaft comprises a sheath extending over at least a portion of the release assembly.

[0380] Example 54: The delivery system of any of the embodiments herein, particularly embodiments 46-53, wherein the release assembly extends from the distal end portion proximally to the proximal end portion.

[0381] Example 55: The delivery system of any of the embodiments herein, particularly embodiments 46-54, wherein the proximal end portion comprises a housing for the elongate shaft.

[0382] Example 56: The delivery system described in any of the embodiments herein, particularly embodiments 46-55, wherein the elongate shaft comprises a deflectable portion configured to deflect transversely relative to the longitudinal axis of the elongate shaft.

[0383] Example 57: The delivery system of any embodiment herein, particularly embodiment 56, wherein at least a portion of the release assembly is configured to deflect with a deflectable portion.

[0384] Example 58: The delivery system of any of the embodiments herein, particularly embodiments 46-57, wherein the elongate shaft comprises a capsule for holding the implant.

[0385] Example 59: The delivery system of any example herein, particularly examples 46-58, further comprising an implant, wherein the implant comprises a prosthetic heart valve.

[0386] Example 60: The delivery system of any example herein, particularly example 59, wherein each opening comprises a respective eyelet of a prosthetic heart valve.

[0387] Example 61: 1. A method, comprising: delivering an implant to a native heart valve utilizing a delivery system; the delivery system comprising an elongate shaft including a proximal end portion and a distal end portion for advancing the implant to the native heart valve; at least a portion of the elongate shaft comprising a tether assembly and a release assembly; the tether assembly comprising one or more attachment tethers configured to attach to the implant, each attachment tether comprising a loop portion configured to protrude from a respective opening in a portion of the implant; the release assembly comprising one or more release tethers configured to extend through one or more of the loop portions to retain the implant in the one or more loop portions, the one or more release tethers configured to be retracted from the one or more loop portions to release the implant from the one or more loop portions.

[0388] Example 62: The method of any example herein, particularly Example 61, wherein each release tether extends through multiple loop portions.

[0389] Example 63: The method of any of the embodiments herein, particularly embodiment 61 or embodiment 62, wherein each release tether extends through at least three of the loop portions.

[0390] Example 64: The method of any of the examples herein, particularly Examples 61-63, wherein the one or more release tethers include at least three of the release tethers.

[0391] Example 65: The method of any of the examples herein, particularly Examples 61-64, wherein one or more release tethers extend circumferentially between the loop portions.

[0392] Example 66: 1. A delivery system for an implant, comprising: an elongate shaft including a proximal end portion and a distal end portion for advancing the implant to an implantation site; one or more connecting tethers each including a first portion and a second portion, the first portion configured to connect to the implant to hold the implant on the elongate shaft; and a disassembly assembly configured to connect to the second portion of the one or more connecting tethers and disassemble the connection to the second portion to release the implant from the elongate shaft.

[0393] Example 67: The delivery system of any example herein, particularly example 66, wherein the disassembly assembly includes a heating element for disassembling the connection to the second portion.

[0394] Example 68: The delivery system of any example herein, particularly example 67, wherein the second portion of the one or more attached tethers is connected to a heating element.

[0395] Example 69: The delivery system described in any example herein, particularly Example 67 or Example 68, wherein the heating element is configured to degrade the second portion of the one or more attached tethers to degrade the connection to the second portion.

[0396] Example 70: The delivery system of any example herein, particularly examples 67-69, wherein the heating element comprises a ring.

[0397] Example 71: The delivery system of any of the embodiments herein, particularly embodiments 67-70, wherein the second portion of the one or more attached tethers comprises a loop that extends over the heating element.

[0398] Example 72: The delivery system described in any of the examples herein, particularly examples 67-71, wherein the disassembly assembly includes an intermediate body connected to the second portion of the one or more attachment tethers, and the heating element is configured to disassemble the intermediate body to disassemble the connection to the second portion.

[0399] Example 73: The delivery system of any example herein, particularly examples 67-72, wherein the heating element comprises a heating filament.

[0400] Example 74: The delivery system of any example herein, particularly examples 67-73, wherein the disassembly assembly includes one or more electrical conduits for passing electrical energy to the heating element.

[0401] Example 75: The delivery system of any example herein, particularly examples 67-74, wherein the disassembly assembly includes a power source for powering the heating element.

[0402] Example 76: The delivery system of any of the embodiments herein, particularly embodiments 67-75, wherein the disassembly assembly includes a first electrical conduit and a second electrical conduit, the first electrical conduit extending along the elongate shaft and having a first electrical terminal, and the second electrical conduit extending along the elongate shaft and having a second electrical terminal, the first electrical terminal being displaceable relative to the second electrical contact and configured to contact the second electrical terminal to complete a circuit for electrical energy to pass through the heating element.

[0403] Example 77: A delivery system described in any of the examples herein, particularly examples 66-76, wherein the first portion of each of the one or more connecting tethers comprises a loop portion configured to protrude from a respective opening in a portion of the implant.

[0404] Example 78: The delivery system described in any of the examples herein, particularly examples 66-77, further comprising a tether manifold and a flexible retention tether, wherein one or more attachment tethers are coupled to the tether manifold and the tether manifold is coupled to the flexible retention tether.

[0405] Example 79: The delivery system of any example herein, particularly examples 66-78, further comprising an implant, wherein the implant comprises a prosthetic heart valve.

[0406] Example 80: The delivery system of any example herein, particularly example 79, wherein the prosthetic heart valve includes one or more eyelets for connecting with the first portions of the one or more attachment tethers.

[0407] Example 81: The method includes delivering an implant to a native heart valve using a delivery system, the delivery system including: an elongate shaft including a proximal end portion and a distal end portion for advancing the implant to the native heart valve; one or more connecting tethers, each including a first portion and a second portion, the first portion configured to connect to the implant to hold the implant on the elongate shaft; and a disassembly assembly configured to connect to the second portion of the one or more connecting tethers and disassemble the connection to the second portion to release the implant from the elongate shaft.

[0408] Example 82: The method of any example herein, particularly example 81, wherein the disassembly assembly includes a heating element for disassembling the connection to the second part.

[0409] Example 83: The method of any example herein, particularly example 82, wherein the second portion of the one or more attachment tethers is connected to a heating element.

[0410] Example 84: The method of any of the embodiments herein, particularly embodiment 82 or embodiment 83, wherein the heating element is configured to degrade the second portion of the one or more attached tethers to degrade the connection to the second portion.

[0411] Example 85: The method of any example herein, particularly Examples 82-84, wherein the heating element comprises a ring.

[0412] Example 86: 1. A delivery system for an implant, comprising: a delivery catheter for advancing the implant to an implantation site, the delivery catheter comprising: an elongate shaft adapted to be deflected in one or more planes; an outer sheath having a distal end portion and a proximal end portion and a length; a pull tether having a distal end portion and a proximal end portion and extending along the length of the outer sheath, the distal end portion being coupled to the outer sheath; a compression coil surrounding at least a portion of the pull tether and including a distal end portion and a proximal end portion, the compression coil not directly connected to the outer sheath and slidable relative to the pull tether; a housing slidably engaged with the proximal end portion of the outer sheath; and an actuator assembly for applying tension to the pull tether to deflect the elongate shaft, whereby force exerted on the compression coil is transmitted through the tube to the support plate.

[0413] Example 87: A delivery system described in any embodiment herein, particularly embodiment 86, wherein the elongate shaft is a rail shaft and the delivery catheter includes one or more shafts adapted to slide relative to the rail shaft.

[0414] Example 88: A delivery system described in any embodiment herein, particularly embodiment 87, wherein one or more shafts are adapted to slide relative to the rail shaft to change the depth of the one or more shafts relative to the rail shaft.

[0415] Example 89: The delivery system described in any example herein, particularly example 87 or example 88, wherein the outer sheath includes a bending portion configured to form a bend when the actuator assembly applies tension to the pull tether.

[0416] Example 90: A delivery system described in any embodiment herein, particularly embodiment 89, wherein 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 rail shaft.

[0417] Example 91: The delivery system of any of the embodiments herein, particularly embodiments 86-90, wherein the distal end portion of the outer sheath comprises a slotted portion having a proximal end portion and a distal end portion, and the distal end portion of the pull tether is coupled to the distal end portion of the slotted portion.

[0418] Example 92: The delivery system of any embodiment herein, particularly embodiment 91, wherein the compression coil is positioned proximal to the proximal end portion of the slotted portion.

[0419] Example 93: The pull tether is a first pull tether, the compression coil is a first compression coil, the tube is a first tube, and tension on the first pull tether deflects the elongate shaft in a first plane. The delivery system includes: a second pull tether having a distal end portion and a proximal end portion and extending along the length of the outer sheath, the distal end portion of the second pull tether being coupled to the outer sheath; and a second compression coil surrounding at least a portion of the second pull tether and including a distal end portion and a proximal end portion, the second compression coil not being directly connected to the outer sheath and slidable relative to the second pull tether. A delivery system as described in any of the examples herein, particularly examples 86 to 92, further comprising: a second tube surrounding at least a portion of the tether and having a distal end portion and a proximal end portion, the second tube not directly connected to the outer sheath and slidable relative to the second pull tether; and a distal end portion of the second tube adapted to abut against the proximal end portion of the second compression coil, wherein the support plate includes an opening through which the second pull tether passes, the support plate is adapted to abut against the proximal end portion of the second tube, and tension applied to the second pull tether causes the elongate shaft to deflect within a second plane transverse to the first plane.

[0420] Example 94: A delivery system as described in any of the examples herein, particularly example 93, further comprising: a third pull tether having a distal end portion and a proximal end portion and extending along the length of the outer sheath, wherein the distal end portion of the third pull tether is coupled to the outer sheath; and a third tube surrounding at least a portion of the third pull tether and including a distal end portion and a proximal end portion, wherein the third tube is not directly connected to the outer sheath and is slidable relative to the third pull tether, wherein the support plate includes an opening through which the third pull tether passes, the support plate is adapted to abut the proximal end portion of the third tube, and wherein tension applied to the third pull tether causes the elongate shaft to deflect within a first plane in a direction opposite to the direction in which the first pull tether deflects the elongate shaft.

[0421] Example 95: A delivery system described in any of the examples herein, particularly Example 94, wherein the first pull tether is attached to the outer shaft at a position distal to where the second pull tether is attached to the outer shaft, and the second pull tether is attached to the outer shaft at a position distal to where the third pull tether is attached to the outer shaft.

[0422] Example 96: The delivery system of any of the embodiments herein, particularly embodiments 86-95, further comprising a handle for receiving the support plate, the housing, and the actuator assembly.

[0423] Example 97: The delivery system of any embodiment herein, particularly embodiment 96, wherein the sliding engagement between the housing and the proximal end portion of the outer sheath allows the outer sheath to slide relative to the handle.

[0424] Example 98: A delivery system described in any of the embodiments herein, particularly embodiment 96 or embodiment 97, wherein the actuator assembly includes a control knob positioned on the handle and the proximal end portion of the pull tether is connected to an adapter engaged by the control knob.

[0425] Example 99: The delivery system of any of the embodiments herein, particularly embodiments 86-98, wherein the sliding engagement between the housing and the proximal end portion of the outer sheath allows the outer sheath to slide relative to the support plate.

[0426] Example 100: The delivery system of any of the Examples herein, particularly Examples 86-99, further comprising an implant, wherein the implant is a prosthetic mitral valve or a prosthetic tricuspid valve.

[0427] Example 101: The method includes delivering an implant to a native heart valve utilizing a delivery system, the delivery system including a delivery catheter for advancing the implant to an implantation site, the delivery catheter including an elongate shaft adapted to be deflected in one or more planes, an outer sheath having distal and proximal end portions and a length, a pull tether having distal and proximal end portions and extending along the length of the outer sheath, the distal end portion being coupled to the outer sheath, and a compression coil surrounding at least a portion of the pull tether, the compression coil including a distal and proximal end portion, the compression coil not directly connected to the outer sheath and slidable relative to the pull tether. a support plate including an opening for the pull tether to pass therethrough, the support plate being adapted to abut the proximal end portion of the tube; a housing slidably engaged with the proximal end portion of the outer sheath; and an actuator assembly for applying tension to the pull tether to deflect the elongate shaft, whereby force exerted on the compression coil is transmitted through the tube to the support plate.

[0428] Example 102: The method of any embodiment herein, particularly embodiment 101, wherein the elongate shaft is a rail shaft and the delivery catheter includes one or more shafts adapted to slide relative to the rail shaft.

[0429] Example 103: The method of any embodiment herein, particularly embodiment 102, wherein the one or more shafts are adapted to slide relative to the rail shaft to vary the depth of the one or more shafts relative to the rail shaft.

[0430] Example 104: The method of any one of the embodiments herein, particularly embodiment 102 or embodiment 103, wherein the outer sheath includes a bending portion configured to form a bend when the actuator assembly applies tension to the pull tether.

[0431] Example 105: The method of any embodiment herein, particularly embodiment 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 rail shaft.

[0432] Example 106: A delivery system for an implant, comprising a delivery catheter for advancing the implant to an implantation site, the delivery catheter including an elongate shaft adapted to be deflected in one or more planes, the elongate shaft having an outer sheath having distal and proximal end portions and a length, a pull tether having distal and proximal end portions and extending along the length of the outer sheath, the distal end portion being coupled to the outer sheath, a lumen surrounding at least a portion of the pull tether and including the distal and proximal end portions, the lumen being not 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 and simultaneously applying a distal compression force to the lumen to deflect the elongate shaft.

[0433] Example 107: The delivery system of any embodiment herein, particularly embodiment 106, wherein the actuator assembly includes a control knob.

[0434] Example 108: The delivery system described in any embodiment herein, particularly embodiment 107, further comprising a handle coupled to a proximal end portion of the elongate shaft, wherein the control knob is positioned on the handle.

[0435] Example 109: The delivery system of any embodiment herein, particularly embodiment 108, wherein the control knob is not threadably engaged with the outer surface of the handle.

[0436] Example 110: A delivery system as described in any of the embodiments herein, particularly embodiments 107-109, further comprising a pull tether adapter coupled to a proximal end portion of the pull tether and an inner lumen adapter coupled to a proximal end portion of the inner lumen, wherein the control knob engages with the pull tether adapter and the inner lumen adapter.

[0437] Example 111: A delivery system described in any of the embodiments herein, particularly embodiment 110, wherein the control knob is adapted to longitudinally drive the pull tether adapter and the lumen adapter in opposite directions upon rotation of the control knob in a single direction.

[0438] Example 112: A delivery system as described in any of the embodiments herein, particularly embodiment 110 or embodiment 111, wherein the control knob has a fixed rotational connection to the pull wire adapter or the lumen adapter and a threaded connection to the other of the pull wire adapter or the lumen adapter.

[0439] Example 113: The delivery system of any embodiment herein, particularly embodiments 106-112, wherein the actuator assembly is adapted to simultaneously apply an equal and opposite tension force to the distal compression force.

[0440] Example 114: The delivery system of any of the embodiments herein, particularly embodiments 106-113, wherein the pull tether is a first pull tether, the lumen is a first lumen, the actuator assembly is a first actuator assembly, wherein applying 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 end portion and a proximal end portion and extending along the length of the outer sheath, wherein the distal end portion of the second pull tether is coupled to the outer sheath; a second lumen surrounding at least a portion of the second pull tether and including a distal end portion and a proximal end portion, the second lumen being not directly connected to the outer sheath and being slidable relative to the second pull tether; and a second actuator assembly for applying tension to the second pull tether and simultaneously applying a distal compressive force to the second lumen to deflect the elongate shaft in a second plane that is transverse to the first plane.

[0441] Example 115: The delivery system of any of the embodiments herein, particularly embodiments 106-114, further comprising a compression coil surrounding at least a portion of the pull tether and including a distal end portion and a proximal end portion, wherein the compression coil is not directly connected to the outer sheath and is slidable relative to the pull tether.

[0442] Example 116: A delivery system described in any of the embodiments herein, particularly embodiments 106 to 115, wherein the elongate shaft is a rail shaft and the delivery catheter includes one or more shafts adapted to slide relative to the rail shaft.

[0443] Example 117: A delivery system described in any embodiment herein, particularly embodiment 116, wherein one or more shafts are adapted to slide relative to the rail shaft to change the depth of the one or more shafts relative to the rail shaft.

[0444] Example 118: The delivery system described in any embodiment herein, particularly embodiment 116 or embodiment 117, wherein the outer sheath includes a bending portion configured to form a bend when the actuator assembly applies tension to the pull tether.

[0445] Example 119: A delivery system described in any embodiment herein, particularly embodiment 118, wherein 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 rail shaft.

[0446] Example 120: The delivery system of any of the Examples herein, particularly Examples 106-119, further comprising an implant, wherein the implant is a prosthetic mitral valve or a prosthetic tricuspid valve.

[0447] Example 121: A method comprising delivering an implant to a native heart valve using a delivery system, the delivery system comprising a delivery catheter for advancing the implant to an implantation site, the delivery catheter comprising an elongate shaft adapted to be deflected in one or more planes, the elongate shaft having an outer sheath having distal and proximal end portions and a length, a pull tether having distal and proximal end portions and extending along the length of the outer sheath, the distal end portion being coupled to the outer sheath, a lumen surrounding at least a portion of the pull tether and including the distal and proximal end portions, the lumen being not 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 and simultaneously applying a distal compression force to the lumen to deflect the elongate shaft.

[0448] Example 122: The method of any embodiment herein, particularly embodiment 121, wherein the actuator assembly comprises a control knob.

[0449] Example 123: The method of any of the embodiments herein, particularly embodiment 122, wherein the delivery catheter includes a handle coupled to a proximal end portion of the elongate shaft, and the control knob is positioned on the handle.

[0450] Example 124: The method of any one of the embodiments herein, particularly embodiment 123, wherein the control knob is not threadably engaged with the outer surface of the handle.

[0451] Example 125: A method as described in any of the embodiments herein, particularly embodiments 122-124, wherein the pull tether adapter is coupled to the proximal end portion of the pull tether, the lumen adapter is coupled to the proximal end portion of the lumen, and the control knob engages with the pull tether adapter and the lumen adapter.

[0452] Example 126: 1. A delivery system for an implant, comprising: an elongate shaft having a proximal end portion and a distal end portion for advancing the implant to an implantation site, the elongate shaft adapted to deflect about a bent portion of the elongate shaft in a first plane; a control mechanism adapted to control deflection of the elongate shaft, the deflection actuator adapted to deflect the elongate shaft in the first plane about the bent portion; a pull tether assembly including a pull tether and an adapter, the pull tether including a distal end portion coupled to the elongate shaft and a proximal end portion coupled to the adapter; and a knob assembly adapted to be rotated in a first direction to create a depth relative to the bent portion of the distal end portion of the elongate shaft and to be rotated in a second direction to accommodate the adapter to deflect the elongate shaft to create a height of the elongate shaft in a direction opposite to the depth.

[0453] Example 127: A delivery system as described in any embodiment herein, particularly embodiment 126, wherein the elongated shaft includes a rail shaft and one or more shafts adapted to slide relative to the rail shaft, and the knob assembly is adapted to be rotated in a first direction to slide the one or more shafts distally relative to the rail shaft to generate depth in the distal end portion.

[0454] Example 128: A delivery system described in any of the embodiments herein, particularly embodiment 127, wherein the knob assembly is adapted to be rotated in a second direction to slide one or more shafts proximally relative to the rail shaft to reduce the depth of the distal end portion.

[0455] Example 129: The delivery system described in any of the examples herein, particularly examples 126 to 128, wherein the pull tether assembly is a first pull tether assembly, the delivery system further comprises a second pull tether assembly including a pull tether and an adapter, and the deflection actuator is adapted to actuate the second pull tether assembly to deflect the elongate shaft in the first plane around the bent portion.

[0456] Example 130: A delivery system described in any of the examples herein, particularly example 129, wherein the deflection actuator is a first deflection actuator, and the delivery system further comprises a second deflection actuator and a third pull tether assembly, the third pull tether assembly including a pull tether and an adapter, and the second deflection actuator is adapted to actuate the third pull tether assembly to deflect the elongate shaft in a second plane around the bent portion, the second plane being transverse to the first plane.

[0457] Example 131: The delivery system of any embodiment herein, particularly embodiment 130, wherein the second plane is perpendicular to the first plane.

[0458] Example 132: A delivery system described in any of the embodiments herein, particularly embodiments 126-131, further comprising a handle coupled to the proximal end portion of the elongate shaft, wherein the knob assembly is positioned on the handle.

[0459] Example 133: A delivery system described in any embodiment herein, particularly embodiment 132, wherein the adapter of the pull tether assembly includes a threaded portion and the knob assembly includes a threaded portion for engaging with the threaded portion of the adapter.

[0460] Example 134: A delivery system as described in any of the embodiments herein, particularly embodiment 133, wherein the handle includes an internal cavity, the adapter is positioned within the internal cavity of the handle, and the threaded portion of the knob assembly is configured to receive the adapter within the internal cavity to create height and advance the adapter within the internal cavity to reduce height.

[0461] Example 135: A delivery system described in any example herein, in particular example 133 or example 134, wherein the elongated shaft includes a rail shaft and one or more shafts adapted to slide relative to the rail shaft, the handle includes a first housing coupled to the rail shaft and a second housing coupled to the one or more shafts adapted to slide relative to the rail shaft, the first housing adapted to slide relative to the second housing, and the knob assembly adapted to slide the first housing relative to the second housing to create depth.

[0462] Example 136: A delivery system as described in any embodiment herein, particularly embodiment 135, wherein the second housing includes a threaded portion, and the knob assembly is axially fixed relative to the first housing and includes a threaded portion for engaging with the threaded portion of the second housing to slide the first housing relative to the second housing to create depth.

[0463] Example 137: A delivery system described in any embodiment herein, particularly embodiment 136, wherein the knob assembly includes a threaded portion for engaging with the threaded portion of the second housing and for engaging with the threaded portion of the adapter of the pull tether assembly.

[0464] Example 138: A delivery system as described in any embodiment herein, particularly embodiment 137, wherein the knob assembly is adapted to alternatively engage with the threaded portion of the second housing and the threaded portion of the adapter to slide the adapter relative to the second housing.

[0465] Example 139: A delivery system described in any embodiment herein, particularly embodiment 138, wherein the threaded portion of the knob assembly disengages from the threaded portion of the second housing to allow the adapter to slide relative to the second housing.

[0466] Example 140: The delivery system of any of the embodiments herein, particularly embodiments 126-139, wherein the knob assembly includes a first portion and a second portion that engages with the first portion such that the first portion rotates with the second portion and the second portion is adapted to release from the first portion such that the second portion is rotatable relative to the second portion.

[0467] Example 141: The delivery system of any embodiment herein, particularly embodiment 140, wherein the capture mechanism engages the first portion with the second portion.

[0468] Example 142: The delivery system of any embodiment herein, particularly embodiment 141, wherein the capture mechanism is adapted to be overcome by a torque force or a longitudinal force.

[0469] Example 143: A delivery system as described in any of the embodiments herein, particularly embodiments 140-142, further comprising a handle coupled to the proximal end portion of the elongate shaft, wherein the knob assembly is positioned on the handle, and the second portion is adapted to slide the adapter of the pull tether assembly relative to the handle to create height.

[0470] Example 144: The delivery system of any of the embodiments herein, particularly embodiments 126-143, wherein the elongate shaft comprises a capsule for extending over the implant.

[0471] Example 145: 146. The delivery system of any of the embodiments herein, particularly 126-144, further comprising an implant, wherein the implant is a prosthetic mitral valve or a prosthetic tricuspid valve.

[0472] Example 146: 1. A method comprising: delivering an implant to a native heart valve utilizing a delivery system, the delivery system comprising: an elongate shaft having a proximal end portion and a distal end portion for advancing the implant to an implantation site, the elongate shaft adapted to deflect about a bent portion of the elongate shaft in a first plane; a control mechanism adapted to control deflection of the elongate shaft, the control mechanism comprising: a deflection actuator adapted to deflect the elongate shaft in the first plane about the bent portion; a pull tether assembly including a pull tether and an adapter, the pull tether having a distal end portion coupled to the elongate shaft and a proximal end portion coupled to the adapter; and a knob assembly adapted to be rotated in a first direction to create a depth relative to the bent portion of the distal end portion of the elongate shaft and to retract the adapter to deflect the elongate shaft to create a height of the elongate shaft in a direction opposite to the depth.

[0473] Example 147: The method described in any of the embodiments herein, particularly embodiment 146, wherein the elongated shaft includes a rail shaft and one or more shafts adapted to slide relative to the rail shaft, and the knob assembly is adapted to be rotated in a first direction to slide the one or more shafts distally relative to the rail shaft to generate depth in the distal end portion.

[0474] Example 148: The method described in any of the embodiments herein, particularly embodiment 147, wherein the knob assembly is adapted to be rotated in a second direction to slide one or more shafts proximally relative to the rail shaft to reduce the depth of the distal end portion.

[0475] Example 149: The method of any of the embodiments herein, particularly embodiments 146-148, wherein the pull tether assembly is a first pull tether assembly, the delivery system further comprises a second pull tether assembly including a pull tether and an adapter, and the deflection actuator is adapted to actuate the second pull tether assembly to deflect the elongate shaft in the first plane around the bent portion.

[0476] Example 150: The method of any of the embodiments herein, particularly embodiment 149, wherein the deflection actuator is a first deflection actuator, the delivery system further comprises a second deflection actuator and a third pull tether assembly, the third pull tether assembly including a pull tether and an adapter, and the second deflection actuator is adapted to actuate the third pull tether assembly to deflect the elongate shaft in a second plane around the bent portion, the second plane being transverse to the first plane.

[0477] Example 151: 1. A delivery system for an implant, comprising: a delivery catheter for advancing the implant to an implantation site, the delivery catheter comprising: a guidewire sheath having a proximal end portion and a distal end and an internal lumen for passage of 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 from the distal end, the spacer body including an opening for the guidewire to project therefrom and a cavity having a diameter larger than the diameter of the internal lumen and adapted for the guidewire to deflect within.

[0478] Example 152: The delivery system of any embodiment herein, particularly embodiment 151, wherein the spacer body comprises an opening for entry of a guidewire into the cavity.

[0479] Example 153: The delivery system of any embodiment herein, particularly embodiment 152, wherein the opening is positioned distal to the aperture.

[0480] Example 154: The delivery system of any of the examples herein, particularly examples 151-153, wherein the cavity has a dome shape.

[0481] Example 155: The delivery system of any of the embodiments herein, particularly embodiments 151-154, wherein the spacer body includes a ridge extending radially inward toward the cavity.

[0482] Example 156: The delivery system of any of the examples herein, particularly examples 151-155, wherein the cavity has a dome shape.

[0483] Example 157: The delivery system of any of the embodiments herein, particularly embodiments 151-156, wherein the spacer body has a conical shape.

[0484] Example 158: The delivery system of any of the embodiments herein, particularly embodiments 151-157, wherein the spacer body comprises a plurality of openings for guidewires to protrude therethrough.

[0485] Example 159: The delivery system of any embodiment herein, particularly embodiment 158, wherein the spacer body includes at least one rib separating the multiple openings.

[0486] Example 160: The delivery system of any of the embodiments herein, particularly embodiments 151-159, wherein the opening is positioned at the distal end of the spacer body.

[0487] Example 161: The delivery system described in any of the embodiments herein, particularly embodiments 151-160, wherein the spacer body includes one or more side walls extending distally to the distal end of the spacer body, and the opening is positioned on the one or more side walls.

[0488] Example 162: The delivery system of any of the embodiments herein, particularly embodiments 151-161, wherein the spacer body is a nose body of the delivery catheter.

[0489] Example 163: The delivery system of any of the embodiments herein, particularly embodiments 151-162, wherein the inner lumen is adapted for distal advancement or proximal storage of a guidewire.

[0490] Example 164: The delivery system of any of the Examples herein, particularly Examples 151-163, further comprising a capsule for retention of the implant.

[0491] Example 165: The delivery system of any of the embodiments herein, particularly embodiments 151-164, further comprising an implant, wherein the implant is a prosthetic mitral valve or a prosthetic tricuspid valve.

[0492] Example 166: 1. A method, comprising: delivering an implant to a native heart valve utilizing a delivery system, the delivery system including a delivery catheter for advancing the implant to an implantation site, the delivery catheter including: a guidewire sheath having a proximal end portion and a distal end and an internal lumen for passage of a guidewire therethrough, the internal lumen having a diameter; and a spacer body positioned at the distal end of the guidewire sheath and protruding distally from the distal end, the spacer body including an opening for the guidewire to protrude therethrough and a cavity having a diameter larger than the diameter of the internal lumen and adapted for the guidewire to deflect within.

[0493] Example 167: The method of any embodiment herein, particularly embodiment 166, wherein the spacer body comprises an opening for entry of a guidewire into the cavity.

[0494] Example 168: The method of any embodiment herein, particularly embodiment 167, wherein the opening is positioned distal to the aperture.

[0495] Example 169: The method of any example herein, particularly examples 166-168, wherein the cavity has a dome shape.

[0496] Example 170: The method of any embodiment herein, particularly embodiments 166-169, wherein the spacer body includes a ridge extending radially inward toward the cavity.

[0497] Any feature of any of the embodiments, including but not limited to any of the above-mentioned Examples 1-170, is applicable to all other aspects and embodiments identified herein, including but not limited to any of the above-mentioned Examples 1-170. Furthermore, any feature of any of the various embodiments, including but not limited to any of the above-mentioned Examples 1-170, can be independently combined, partially or entirely, in any manner with other embodiments described herein; for example, one, two, three, or more embodiments can be combined, entirely or partially. Furthermore, any feature of the various embodiments, including but not limited to any of the above-mentioned Examples 1-170, can be optional with other embodiments. Any embodiment of a method can be implemented by a system or device of another embodiment, and any aspect or embodiment of a system or device can be configured to implement a method of another embodiment or embodiment, including but not limited to any of the above-mentioned Examples 1-170.

[0498] In summary, while aspects of the present specification are emphasized by reference to particular examples, it will be understood that those skilled in the art will readily recognize that these disclosed examples are merely illustrative of the principles of the subject matter disclosed herein. Accordingly, it will be understood that the disclosed subject matter is not limited in any way to the particular methodology, protocols, and / or reagents, etc., described herein. Therefore, various modifications or variations of the disclosed subject matter, or alternative configurations, can be made in accordance with the teachings herein without departing from the spirit of the specification. Finally, the terminology used herein is for the purpose of describing particular examples only and is not intended to limit the scope of the systems, devices, and methods as disclosed herein, which are defined solely by the claims. Therefore, the systems, devices, and methods are not limited to those precisely as shown and described.

[0499] Particular embodiments of the systems, devices, and methods are described herein, including the best modes known to the inventors for carrying out the same. Of course, variations on these described embodiments will become apparent to those skilled in the art upon reading the foregoing description. The inventors anticipate that skilled artisans will adopt such variations as appropriate, 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. Furthermore, unless otherwise indicated herein or clearly contradicted by context, combinations of the above-described examples in all possible variations thereof are encompassed by the systems, devices, and methods.

[0500] Groupings of alternative embodiments, elements, or steps of systems, devices, and methods are not to be construed as limitations. Members of each group may be referenced and claimed individually or in any combination with members of other groups disclosed herein. It is contemplated that one or more members of a group may be included within, or deleted from, a group for reasons of convenience and / or patentability. When any such inclusion or deletion is made, the specification is deemed to include the modified group, and thus fulfills the recitation of all Markush groups used in the appended claims.

[0501] Unless otherwise indicated, all numbers expressing features, items, quantities, parameters, characteristics, terms, and the like used in the specification and claims are to be understood in all instances as being modified by the term "about." As used herein, the term "about" means that the feature, item, quantity, parameter, characteristic, or term so qualified encompasses approximations that may vary but may still perform the desired operation or process described herein.

[0502] The terms "a," "an," "the," and similar reference words, as used in the context of describing systems, devices, and methods (particularly in the context of the claims below), should be construed to cover both the singular and the plural unless otherwise indicated herein or clearly contradicted by context. All methods described herein may be performed in any suitable order unless otherwise indicated herein or clearly contradicted by context. The use of any and all example or exemplary language (e.g., "etc.") as provided herein is merely to more clearly illustrate the systems, devices, and methods and does not pose a limitation on the scope of the otherwise claimed systems, devices, and methods. No language in the specification should be construed as indicating any non-claimed element essential to the practice of the systems, devices, and methods.

[0503] All patents, patent publications, and other publications referenced or identified in this specification are individually and expressly incorporated herein by reference in their entirety for the purpose of describing and disclosing, for example, the compositions and methodologies described therein that may be used in connection with the systems, apparatus, and methods. These publications are provided only as of the filing date of this application. Nothing in this regard should be construed as an admission that the inventors are not entitled to antedate such disclosure by virtue of prior invention or for any other reason. All statements as to the date or representations regarding the contents of these documents are based on the information available to the applicant and do not constitute an admission as to the accuracy of the dates or contents of these documents.

Claims

1. 1. A system for replacing the function of a native atrioventricular valve, comprising: a prosthetic heart valve including a self-expanding frame and a plurality of leaflets disposed within a lumen of the frame to allow unidirectional blood flow; a delivery catheter having an elongate shaft for advancing the prosthetic heart valve through the patient's vascular system to the native atrioventricular valve, the delivery catheter including a capsule along a distal end 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 linked tethers disposed along a distal end portion of the tether assembly, the linked tethers sized to extend through openings in the prosthetic heart valve; a release assembly including one or more flexible release tethers configured to extend through loop portions of the coupling tether to secure the prosthetic heart valve to the tether assembly, the one or more release tethers being retractable for removal from the one or more loop portions, thereby allowing the tether assembly to be released from the prosthetic heart valve; The prosthetic heart valve may be ejected from the capsule and allowed to expand and operate while attached to the tether assembly, and the prosthetic heart valve may be released from the tether assembly after confirming proper deployment and operation within the native atrioventricular valve.

2. The tether assembly a tether manifold attached to the plurality of connecting tethers; The system of claim 1 , further comprising a flexible retention tether coupled to the tether manifold and extending proximally from the tether manifold for engaging a tether actuator.

3. The system of claim 2 , wherein the tether manifold comprises a wire forming a loop, and the plurality of connecting tethers loop around the loop of the tether manifold.

4. The system of claim 3 , wherein the plurality of connecting tethers comprises a continuous suture looped multiple times around the loops of the tether manifold to form each of the plurality of connecting tethers.

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

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

7. The system of any preceding claim, wherein the release assembly includes at least three of the release tethers.

8. The system of any preceding claim, wherein the release assembly includes only one of the release tethers.

9. The release assembly includes: a release tether manifold from which a plurality of said release tethers branch; The system of any preceding claim, further comprising: a retractable tether coupled to the release tether manifold 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 capsule is retractable to eject the prosthetic heart valve from the capsule.

11. 11. The system of claim 1, wherein the elongate shaft includes a plurality of shafts, at least one of the plurality of shafts comprising a rail shaft adapted to form a bending portion for bending another of the elongate shafts.

12. 12. The system of claim 11, wherein the rail shaft is adapted to bend 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. 13. The system of claim 12, wherein the rail shaft is adapted to slide relative to the capsule to vary a depth of the capsule relative to the bent portion, and the rail shaft is adapted to bend in a third direction within the first plane, the third direction being opposite to the first direction to vary a height of the capsule.

14. 14. The system of claim 13, wherein the delivery catheter includes a handle positioned at a proximal end portion of the elongate shaft, the handle including a knob assembly for actuating a pull tether to bend the rail shaft in the third direction to change the height of the capsule.

15. 15. The system of claim 12, wherein the delivery catheter includes a handle positioned at a proximal end portion of the elongate shaft, the handle including a deflection actuator adapted to deflect the elongate shaft in the first direction within the first plane.

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

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

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

19. 19. The system of claim 17 or claim 18, wherein the tether actuator is adapted to receive the tether assembly for receiving the prosthetic heart valve into the distal pusher.

20. 20. The system of any one of claims 1 to 19, wherein the delivery catheter includes a handle positioned at a proximal end portion of the elongate shaft, the handle including 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. 21. The system of any of claims 1-20, wherein the delivery catheter includes a handle positioned at a proximal end portion of the elongate shaft, the system further comprising a stabilizer for coupling to the handle for stabilizing the delivery catheter during deployment of the prosthetic heart valve into the native atrioventricular valve.

22. The system of any preceding claim, wherein the prosthetic heart valve includes at least nine of the openings.

23. The system of any preceding claim, wherein the opening is positioned at an inlet end portion of the prosthetic heart valve.

24. The system of any preceding claim, wherein the opening is an eyelet.

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

26. 1. A system for replacing the function of a native atrioventricular valve, comprising: a prosthetic heart valve including a self-expanding frame and a plurality of leaflets disposed within a lumen of the frame to allow unidirectional flow; 1. A delivery catheter comprising: an elongate shaft for advancing the prosthetic heart valve into the native atrioventricular valve, the elongate shaft including a proximal end portion and a distal end portion, the elongate shaft adapted to deflect in a first plane about a bent portion of the elongate shaft; a control mechanism adapted to control deflection of the elongate shaft, a deflection actuator adapted to deflect the elongate shaft in the first plane about the bend portion; a pull tether assembly including a pull tether and an adapter, the pull tether including a distal end portion coupled to the elongate shaft and a proximal end portion coupled to the adapter; a control mechanism including a knob assembly adapted to be rotated in a first direction to create a depth relative to the bent portion of the distal end portion of the elongate shaft and to be rotated in a second direction to accommodate the adapter to deflect the elongate shaft to create a height of the elongate shaft in a direction opposite to the depth; and

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

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

29. The system of any of claims 26 to 28, wherein the pull tether assembly is a first pull tether assembly, the system further comprising a second pull tether assembly including a pull tether and an adapter, and the deflection actuator is adapted to actuate the second pull tether assembly to deflect the elongate shaft in the first plane around the bent portion.

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

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

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

33. 33. The system of claim 32, wherein the adapter of the pull tether assembly includes a threaded portion, and the knob assembly includes a threaded portion for engaging the threaded portion of the adapter.

34. 34. The system of claim 33, wherein the handle includes an internal cavity, the adapter is positioned within the internal cavity of the handle, and the threaded portion of the knob assembly is configured to receive the adapter within the internal cavity to create the height and to advance the adapter within the internal cavity to reduce the height.

35. 35. The system of claim 33 or claim 34, wherein the elongated shaft includes a rail shaft and one or more shafts adapted to slide relative to the rail shaft, the handle includes a first housing coupled to the rail shaft and a second housing coupled to the one or more shafts adapted to slide relative to the rail shaft, the first housing adapted to slide relative to the second housing, and the knob assembly adapted to slide the first housing relative to the second housing to create the depth.

36. 36. The system of claim 35, wherein the second housing includes a threaded portion, and the knob assembly is axially fixed relative to the first housing and includes a threaded portion for engaging the threaded portion of the second housing to slide the first housing relative to the second housing to create the depth.

37. 37. The system of claim 36, wherein the knob assembly includes a threaded portion for engaging the threaded portion of the second housing and for engaging the threaded portion of the adapter of the pull tether assembly.

38. 38. The system of 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. 39. The system of 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. 40. The system of any of claims 26-39, wherein the knob assembly includes a first portion and a second portion that engages with the first portion such that the first portion rotates with the second portion and the second portion is adapted to disengage from the first portion such that the second portion is rotatable relative to the second portion.

41. 41. The system of claim 40, wherein a capture mechanism engages the first portion with the second portion.

42. 42. The system of claim 41, wherein the capture mechanism is adapted to be overcome by a torque force or a longitudinal force.

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

44. one or more attachment tethers, each including a first portion and a second portion, the first portion configured to attach to the prosthetic heart valve to retain the prosthetic heart valve on the elongate shaft; 44. The system of any of claims 26-43, further comprising: a disassembly assembly configured to connect to the second portion of the one or more attachment tethers and to disassemble the connection to 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.

Images