Systems and methods for heart valve treatment

Abstract

Devices, systems and methods are described herein to facilitate treatment of a heart valve. Concepts for controlling height and depth and rotation of the delivery system may be actuated to navigate to a desired position and orientation for implantation. A treatment device deployed too deep or ventricular in a tricuspid deployment may be adjusted in position through use of a height adjustment or actuation of the delivery system. Prosthetic heart valves and other treatment devices for improved deployment to a native heart valve are disclosed.

Description

SYSTEMS AND METHODS FOR HEART VALVE TREATMENTCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Application No. 63 / 667,679, filed July 3, 2024, the entire contents of which is incorporated herein by reference.BACKGROUND

[0002] Human heart valves, which include the aortic, pulmonary, mitral and tricuspid valves, function essentially as one-way valves operating in synchronization with the pumping heart. Healthy valves allow blood to flow downstream, but block blood from flowing upstream. Diseased heart valves exhibit impairments, such as narrowing of the valve and / or regurgitation, which inhibit the valves’ ability to control blood flow. Such impairments can reduce the heart’s bloodpumping efficiency and can be a debilitating and life-threatening condition. For example, valve insufficiency can lead to conditions such as heart hypertrophy or dilation of the ventricle. Finding the best ways to treat heart valves, e.g., to repair or replace impaired heart valves, is important. Navigating relative to various anatomical features in order to treat heart valves can be particularly challenging.SUMMARY

[0003] This summary is meant to provide some examples and is not intended to be limiting of the scope of the invention in any way. For example, any feature included in an example of this summary is not required by the claims, unless the claims explicitly recite the features. Also, the features, components, steps, concepts, etc. described in some implementations in this summary and elsewhere in this disclosure can be combined in a variety of ways. Various features and steps as described elsewhere in this disclosure may be included in the examples summarized here.

[0004] Some implementations of the present disclosure arc directed to prosthcscs and / or systems, devices and / or methods of use to deliver and / or controllably deploy a prosthesis, such as but not limited to a replacement heart valve or other device or implant, to a desired location within the body. In some implementations, a treatment device (e.g., an implant, replacement heart valve, a repair device, a valve treatment device, etc.) and methods for delivering a treatment device to a native heart valve, such as a mitral, tricuspid, aortic, or pulmonic valve, are provided.

[0005] In some implementations, a system (e.g., a delivery system, treatment system, etc.) and method arc provided for delivering a treatment device (e.g., an implant, replacement heart valve, valve treatment device, etc.) to a native valve location (e.g., a tricuspid, mitral, aortic, or pulmonic valve position). In some implementations, components of the system facilitate bending of the system / delivery system to produce a desired position of implantation.

[0006] In some implementations, height and depth of the system / delivery system can be adjusted (e.g., by actuating controls of the system, etc.) to navigate to a desired position of implantation. For example, an implant positioned too deep or too ventricular in an atrioventricular (e.g., tricuspid, mitral, etc.) deployment can be adjusted to a different or better position (e.g., a higher or more atrial position) by adjusting the height of the system (e.g., by actuating controls to adjust the height of a distal portion of the system, etc.).

[0007] In some implementations, navigation and / or positioning within a heart can be improved through use of a height adjustment or height actuation. Similar actuation may be utilized for other native valves or for deployment to other implantation sites.

[0008] In some implementations, treatment devices, such as prosthetic heart valves, are disclosed herein for improved deployment and securement to a native heart valve.

[0009] In some implementations, treatment devices herein (e.g., prosthetic heart valves, replacement heart valves, implants, valve treatment devices, etc.) can further include anchors having asymmetric positioning and / or unequal spacing to provide one or more sections of an outer circumference of a treatment device (e.g., a prosthetic heart valve, implant, etc.) that lack an anchor / anchors. In some implementations, such section(s) can be positioned at sensitive or critical areas of a native heart valve, including a septal leaflet side of a tricuspid valve, at nerve bundles or nodes, etc. Other positions or uses are also contemplated.

[0010] In some implementations, a system (e.g., a delivery system for a treatment device, implant, etc.) comprises an elongate shaft assembly. In some implementations, the elongate shaft assembly includes a first shaft including a distal end portion of the elongate shaft assembly. In some implementations, the elongate shaft assembly includes a treatment device retention area for retaining the treatment device.

[0011] In some implementations, the elongate shaft assembly includes a rail shaft assembly. In some implementations, the rail shaft assembly includes a rail shaft adapted to slide relative to the first shaft.

[0012] In some implementations, the rail shaft includes a first bend portion adapted to bend towards a first direction, a second bend portion adapted to bend towards a second direction that is opposed to the first direction.

[0013] In some implementations, the system (e.g., the rail shaft, the first shaft, another portion, etc.) includes first pull tether for bending the first bend portion. In some implementations, the system (e.g., the rail shaft, the first shaft, another portion, etc.) includes a second pull tether for bending the second bend portion, the second pull tether having a proximal end portion.

[0014] In some implementations, a handle is coupled to the elongate shaft assembly. In some implementations, the handle includes a first housing coupled to the rail shaft. In some implementations, the handle includes a second housing coupled to the first shaft and adapted to engage the proximal end portion of the second pull tether.

[0015] In some implementations, the second housing is adapted to slide in a first direction relative to the first housing to produce a depth of the distal end portion of the elongate shaft assembly relative to the rail shaft and adapted to slide in a second direction relative to the first housing to retract the second pull tether to bend the second bend portion towards the second direction that is opposed to the first direction.

[0016] In some implementations, a system (e.g., a delivery system, etc.) comprises an elongate shaft assembly including a device retention area for retaining the treatment device. In some implementations, at least a portion of the elongate shaft assembly includes an interior lumen. In some implementations, at least a portion of the elongate shaft assembly includes a first bend portion adapted to bend towards a first direction.

[0017] In some implementations, at least a portion of the elongate shaft assembly includes a second bend portion adapted to bend towards a second direction that is opposed to the first direction.

[0018] In some implementations, at least a portion of the elongate shaft assembly includes a third bend portion that is adapted to bend towards a third direction that is transverse to the first direction.

[0019] In some implementations, the system (e.g., the elongate shaft assembly, another portion of the system, etc.) includes a first pull tether for bending the first bend portion.

[0020] In some implementations, the system (e.g., the elongate shaft assembly, another portion of the system, etc.) includes a second pull tether for bending the second bend portion.

[0021] In some implementations, the system (e.g., the elongate shaft assembly, another portion of the system, etc.) includes a third pull tether for bending the third bend portion.

[0022] In some implementations, wherein at least one of the first pull tether, the second pull tether, or the third pull tether spirals within the interior lumen to be positioned circumferentially closer to one other of the first pull tether, the second pull tether, or the third pull tether.

[0023] In some implementations, a system (e.g., a delivery system, etc.) comprises an elongate shaft assembly including an implant retention area for retaining a treatment device (e.g., an implant, a replacement heart valve, a prosthetic heart valve, a repair device, etc.).

[0024] In some implementations, at least a portion of the elongate shaft assembly includes a first bend portion adapted to bend towards a first direction.

[0025] In some implementations, at least a portion of the elongate shaft assembly includes a second bend portion adapted to bend towards a second direction that is opposed to the first direction.

[0026] In some implementations, at least a portion of the elongate shaft assembly includes a third bend portion that is adapted to bend towards a third direction that is transverse to the first direction.

[0027] In some implementations, the system (e.g., a portion of the elongate shaft assembly, another portion of the system, etc.) includes a first pull tether for bending the first bend portion and the second bend portion. In some implementations, the system includes a second pull tether for bending the third bend portion.

[0028] In some implementations, a system (e.g., a delivery system, a treatment system, etc.) comprises an elongate shaft assembly. In some implementations, the elongate shaft assembly includes a treatment device retention area for retaining the treatment device (e.g., an implant, a replacement heart valve, a repair device, etc.).

[0029] In some implementations, the system (e.g., the elongate shaft assembly, another portion of the system, etc.) includes a sheath including a capsule for extending over the implant retention area.

[0030] In some implementations, the sheath extends along a longitudinal axis (e.g., of the elongate shaft assembly).

[0031] In some implementations, the system includes a pull tether adapted to retract to apply a force to the sheath to bend the sheath in a direction transverse to the longitudinal axis.

[0032] In some implementations, a system (e.g., a delivery system, a treatment system, etc.) comprises an elongate shaft assembly including a device retention area for retaining the treatment device, and at least a portion of the elongate shaft assembly being precurved to bend the elongate shaft assembly in a direction transverse to a longitudinal extent or longitudinal axis of the elongate shaft assembly.

[0033] In some implementations, a system (e.g., a delivery system, a treatment system, etc.) comprises an elongate shaft assembly including a treatment device retention area for retaining a treatment device.

[0034] In some implementations, the system comprises a nose body positioned at a distal tip of the elongate shaft assembly. In some implementations, the nose body is expandable in size and / or is retractable to deflect the elongate shaft assembly.

[0035] In some implementations, a system (e.g., a delivery system, a treatment system, etc.) comprises an elongate shaft assembly including a treatment device retention area for retaining a treatment device (e.g., an implant, a prosthetic heart valve, a repair device, etc.).

[0036] In some implementations, the system comprises a nose body positioned at a distal tip of the elongate shaft assembly. In some implementations, the nose body is adapted to engage a guide wire and is retractable to deflect the elongate shaft assembly upon retraction of the guide wire.

[0037] In some implementations, a treatment device (e.g., an implant, a prosthetic heart valve, a replacement heart valve, a repair device, etc.) comprises a self-expanding frame sized for deployment within a native heart valve. In some implementations, the frame has an inflow end portion and an outflow end portion.

[0038] In some implementations, the frame includes an inner frame or inner frame portion, and an outer frame or outer frame portion positioned radially outward of the inner frame / inner frame portion.

[0039] In some implementations, the outer frame / outer frame portion includes a plurality of stmts. In some implementations, the outer frame / outer frame portion includes a plurality of elongate beams each having a proximal end portion coupled to at least one of the plurality of stmts and each extending in an outflow direction to a tip of the respective one of the elongate beams.

[0040] In some implementations, the treatment device is configured as a prosthetic heart valve that comprises a plurality of prosthetic valve leaflets positioned within an interior of the inner frame.

[0041] In some implementations, the treatment device includes a plurality of anchors (e.g., ventricular anchors, atrial anchors, other anchors, etc.). In some implementations, one, some, or all anchors have a hook shape, but other shapes and configurations are also possible. In some implementations, one, some, or all of the anchors are adapted to extend around native leaflets of the native heart valve. In some implementations, one, some, or all of the anchors is adapted to press a native leaflet against a respective one of the elongate beams for securing the treatment device within the native heart valve.

[0042] In some implementations, a treatment device (e.g., an implant, a prosthetic heart valve, a replacement heart valve, a repair device, etc.) comprises a self-expanding frame sized for deployment within a native heart valve, the frame having an inflow end portion and an outflow end portion.

[0043] In some implementations, the treatment device is configured as a prosthetic heart valve comprising a plurality of prosthetic valve leaflets positioned within an interior of the frame.

[0044] In some implementations, the treatment device includes a plurality of anchors (e.g., ventricular anchors, atrial anchors, other anchors, etc.). In some implementations, one, some, orall anchors have a hook shape, but other shapes and configurations are also possible. In some implementations, one, some, or all of the anchors arc adapted to extend around native leaflets of the native heart valve.

[0045] In some implementations, anchors of the plurality of anchors are unequally spaced about an outer circumference of the prosthetic heart valve. In some implementations, anchors of the plurality of anchors are equally spaced about an outer circumference of the prosthetic heart valve.

[0046] In some implementations, the plurality of anchors includes a first of the anchors and a second of the anchors that bound (e.g., are on either side of) a section of the outer circumference (e.g., a section having no anchor, a section where an anchor has been removed, an open section, etc.). In some implementations, the first and the second of the anchors each extend to a lesser axial height in the inflow direction of the prosthetic heart valve than at least one other of the plurality of anchors. In some implementations, the first and the second of the anchors each extend to a lesser axial height in the inflow direction of the prosthetic heart valve than all the other of the plurality of anchors.

[0047] In some implementations, a treatment device (e.g., an implant, a prosthetic heart valve, a replacement heart valve, a repair device, etc.) for treating a native heart valve comprises a selfexpanding frame sized for deployment within the native heart valve. In some implementations, the frame has a proximal end, atrial end, or inflow end portion and a distal end, ventricular end, or outflow end portion.

[0048] In some implementations, the treatment device is configurated as a prosthetic heart valve and comprises a plurality of prosthetic valve leaflets positioned within an interior of the frame.

[0049] In some implementations, the treatment device includes a plurality of anchors (e.g., ventricular anchors, atrial anchors, other anchors, etc.). In some implementations, one, some, or all anchors optionally have a hook shape, but other shapes and configurations are also possible. In some implementations, one, some, or all of the anchors are adapted to extend around native leaflets of the native heart valve.

[0050] In some implementations, at least one, some, or all of the plurality of anchors are unequally spaced about an outer circumference of the prosthetic heart valve. In some implementations, at least one, some, or all of the plurality of anchors are equally spaced about an outer circumference of the prosthetic heart valve.

[0051] In some implementations, anchors of the plurality of anchors are spaced such that the outer circumference of the treatment device includes a section having a circumferential spacing between two adjacent anchors of the anchors that is larger than another circumferential spacing between two adjacent anchors of the anchors. In some implementations, the section has circumferential spacing between two adjacent anchors of the plurality of anchors that is larger than any other circumferential spacing between two adjacent anchors of the plurality anchors.

[0052] In some implementations, the section includes an area that would have included an anchor if the plurality of anchors were equally spaced around the outer circumference.

[0053] In some implementations, the treatment device includes one or more imaging markers for indicating a position of the section.

[0054] In some implementations, a treatment device (e.g., an implant, a prosthetic heart valve, a replacement heart valve, a repair device, etc.) for treating a native heart valve comprises a selfexpandable frame sized for deployment within the native heart valve. In some implementations, the frame has a proximal end, atrial end, or inflow end portion and a distal end, ventricular end, or outflow end portion.

[0055] In some implementations, the treatment device includes a plurality of prosthetic valve leaflets positioned within an interior of the frame.

[0056] In some implementations, the treatment device includes a plurality of anchors (e.g., ventricular anchors, atrial anchors, other anchors, etc.). In some implementations, one, some, or all anchors optionally have a hook shape, but other shapes and configurations are also possible. In some implementations, one, some, or all of the anchors are adapted to extend around native leaflets of the native heart valve.

[0057] In some implementations, at least one, some, or all of the plurality of anchors are unequally spaced about an outer circumference of the prosthetic heart valve. In someimplementations, at least one, some, or all of the plurality of anchors are equally spaced about an outer circumference of the prosthetic heart valve.

[0058] In some implementations, anchors of the plurality of anchors are unequally spaced about an outer circumference of the treatment device such that the outer circumference includes a section having a circumferential spacing between two adjacent anchors of the plurality of anchors that is larger than another circumferential spacing between two adjacent anchors of the plurality of anchors. In some implementations, the section has circumferential spacing between two adjacent anchors of the plurality of anchors that is larger than any other circumferential spacing between two adjacent anchors of the plurality of anchors.

[0059] In some implementations, an arm is coupled to the frame. In some implementations, the arm extends axially in a distal, ventricular, or outflow direction to a tip of the arm. In some implementations, the arm extends axially in a proximal, atrial, or inflow direction to a tip of the arm.

[0060] In some implementations, the arm is positioned at a circumferential position corresponding to the section and having a length that is less than the length of each of the plurality of anchors.

[0061] In some implementations, a treatment device (e.g., an implant, a prosthetic heart valve, a replacement heart valve, a repair device, etc.) for treating a native heart valve comprises a selfexpanding frame sized for deployment within the native heart valve. In some implementations, the frame has an inflow end portion and an outflow end portion.

[0062] In some implementations, the treatment device includes a plurality of prosthetic valve leaflets positioned within an interior of the frame.

[0063] In some implementations, the treatment device includes a plurality of anchors (e.g., ventricular’ anchors, atrial anchors, other anchors, etc.). In some implementations, the anchors are adapted to extend around native leaflets of the native heart valve.

[0064] In some implementations, one, some, or all of the anchors includes a connecting portion for connecting to the self-expanding frame and extends to a respective tip of the anchor. In some implementations, at least one of the plurality of anchors is shaped such that the tip of the anchor isangled relative to the connecting portion of the anchor circumferentially towards a circumferentially adjacent anchor of the plurality of anchors.

[0065] In some implementations, a treatment device (e.g., an implant, a prosthetic heart valve, a replacement heart valve, a repair device, etc.) for treating a native heart valve comprises a selfexpanding frame sized for deployment within the native heart valve. In some implementations, the frame has an inflow end portion and an outflow end portion.

[0066] In some implementations, the treatment device includes a plurality of prosthetic valve leaflets positioned within an interior of the frame.

[0067] In some implementations, the treatment device includes a plurality of anchors (e.g., ventricular anchors, atrial anchors, other anchors, etc.). In some implementations, the anchors arc adapted to extend around native leaflets of the native heart valve.

[0068] In some implementations, one, some, or all of the anchors is spaced circumferentially from a circumferentially adjacent one of the plurality of anchors. In some implementations, one, some, or all of the anchors protrudes radially outward from the frame.

[0069] In some implementations, a first anchor of the plurality of anchors is angled in a circumferential direction away from a circumferentially adjacent second anchor of the plurality of anchors such that a size of a circumferential gap between the first anchor and the second anchor is larger than a size of a circumferential gap between two other anchors of the plurality of anchors.

[0070] In some implementations, a treatment device (e.g., an implant, a prosthetic heart valve, a replacement heart valve, a repair device, etc.) for treating a native heart valve comprises a selfexpanding frame sized for deployment within the native heart valve. In some implementations, the frame has an inflow end portion and an outflow end portion.

[0071] In some implementations, the treatment device includes a plurality of prosthetic valve leaflets positioned within an interior of the frame.

[0072] In some implementations, the treatment device includes a plurality of anchors (e.g., ventricular anchors, atrial anchors, other anchors, etc.). In some implementations, the anchors are adapted to extend around native leaflets of the native heart valve.

[0073] In some implementations, the treatment device includes a telescoping section and / or a telescoping mechanism that is adapted to allow an axial position of at least one of the plurality of anchors to be adjusted relative to an axial position of the self-expanding frame in vivo.

[0074] In some implementations, a treatment device (e.g., an implant, a prosthetic heart valve, a replacement heart valve, a repair device, etc.) for treating a native heart valve comprises a selfexpanding frame sized for deployment within the native heart valve. In some implementations, the frame has an inflow end portion and an outflow end portion.

[0075] In some implementations, the treatment device includes a plurality of prosthetic valve leaflets positioned within an interior of the frame.

[0076] In some implementations, the treatment device includes a plurality of anchors (e.g., ventricular anchors, atrial anchors, other anchors, etc.). In some implementations, the anchors are adapted to extend around native leaflets of the native heart valve and are coupled to the frame.

[0077] In some implementations, the treatment device includes a release control and / or release mechanism adapted to allow at least one of the plurality of anchors to release from the frame and be removed from the frame in vivo.

[0078] In some implementations, a system (e.g., a delivery system, a treatment system, etc.) comprises an elongate shaft assembly. In some implementations, the elongate shaft assembly includes a treatment device retention area for retaining the treatment device (e.g., an implant, a replacement heart valve, a repair device, etc.).

[0079] In some implementations, the elongate shaft assembly extends along a longitudinal axis.

[0080] In some implementations, the system includes a rotation mechanism and / or rotation control adapted to rotate the treatment device about the longitudinal axis of the elongate shaft assembly.

[0081] In some implementations, methods herein can include delivering a treatment device (e.g., an implant, a prosthetic heart valve, a replacement heart valve, a repair device, etc.) to a native heart valve utilizing a delivery system, wherein the delivery system can include any of the features disclosed herein.

[0082] In some implementations, methods herein can include deploying a treatment device (c.g., an implant, a prosthetic heart valve, a replacement heart valve, a repair device, etc.) to a native heart valve, the treatment device may include any of the features disclosed herein.

[0083] In some implementations, the methods herein can involve a treatment device with a plurality of anchors. In some implementations, anchors of the plurality of anchors are unequally spaced about an outer circumference of the treatment device such that the outer circumference includes a section having a circumferential spacing between two adjacent anchors of the plurality of anchors that is larger than another circumferential spacing between two adjacent anchors of the plurality of anchors.

[0084] In some implementations, the method includes positioning the section at a desired or optimal location or anatomical site (e.g., positioning the section near a nerve bundle or node, e.g., to limit interaction therewith).

[0085] In some implementations, the method includes positioning the section at a first location or anatomical site. Evaluating the position of the treatment device (e.g., using imaging, etc.). Then adjusting (e.g., rotating, etc.) the position of the treatment device to move the section to a second location or anatomical site (e.g., moving the section near or adjacent a nerve bundle or node, e.g., to limit interaction of the treatment device therewith).

[0086] In some implementations, methods herein can include deploying a prosthetic heart valve / replacement heart valve to a native heart valve, the prosthetic heart valve can include any of the features disclosed herein.

[0087] Any of the above method(s) and any methods of using the systems, assemblies, apparatuses, devices, etc. herein can be performed on a living subject (e.g., human or other animal) or on a simulation (e.g., a cadaver, cadaver heart, imaginary person, simulator, etc.). With a simulation, the body parts can optionally be referred to as “simulated” (e.g., simulated heart, simulated tissue, etc.) and can optionally comprise computerized and / or physical representations.

[0088] Any of the above systems, assemblies, devices, apparatuses, components, etc. can be sterilized (e.g., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.) to ensure they are safe for use with patients, and the methods herein can comprise (or additional methods compriseor consist of) sterilization of one or more systems, devices, apparatuses, components, etc. herein (c.g., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.).BRIEF DESCRIPTION OF THE DRAWINGS

[0089] FIG. 1 illustrates a perspective view of an example delivery system including aesthetic features thereof.

[0090] FIG. 2 illustrates a perspective view of an end portion of the example delivery system illustrating an outer sheath assembly.

[0091] FIG. 3 illustrates a perspective view of an end portion of the example delivery system illustrating an intermediate shaft or mid shaft assembly.

[0092] FIG. 4 illustrates a perspective view of an end portion of the example delivery system illustrating a rail shaft assembly.

[0093] FIG. 5 illustrates a perspective view of an end portion of the example delivery system illustrating an inner shaft assembly.

[0094] FIG. 6 illustrates a perspective view of an end portion of the example delivery system illustrating an example nose body assembly.

[0095] FIG. 7 illustrates a perspective view of the example nose body assembly of FIG. 6 at an opposite view than shown in FIG. 6.

[0096] FIG. 8 illustrates a cross-sectional view of the example nose body assembly of FIG. 6.

[0097] FIG. 9 illustrates a perspective view of an end portion of the example delivery system illustrating an intermediate shaft or mid shaft assembly with a portion of the intermediate shaft excluded from view.

[0098] FIG. 10 illustrates a plan view or flat view of cuts of an intermediate shaft.

[0099] FIGS. 11 A-D illustrate views of cut patterns for a shaft.

[0100] FIG. 1 IE illustrates a perspective view of an end of an intermediate shaft.

[0101] FIG. 1 IF illustrates a perspective view of an opposite side of the end of the intermediate shaft that is shown in FIG. 1 IE.

[0102] FIG. 11G illustrates a perspective view of an intermediate shaft.

[0103] FIG. 11 H illustrates a plan view or flat view of cuts of an intermediate shaft.

[0104] FIG. 12 illustrates a perspective view of a rail shaft.

[0105] FIG. 13 illustrates the rail shaft of FIG. 12 at an opposite side of the rail shaft shown in FIG. 12.

[0106] FIG. 14 illustrates a perspective view of a pull tether assembly for the rail shaft assembly.

[0107] FIG. 15 illustrates a partial cross-sectional view of the pull tether assembly of FIG.14 at an opposite side than shown in FIG. 14.

[0108] FIG. 16 illustrates a perspective view of the proximal end portions of the pull tethers of the pull tether assembly shown in FIG. 14.

[0109] FIG. 17 illustrates a cross-sectional view of an example implant retention area of the elongate shaft assembly shown in FIG. 1.

[0110] FIG. 18 illustrates a side view of an example handle of the example delivery system shown in FIG. 1, including aesthetic features thereof.

[0111] FIG. 19 illustrates a cross-sectional view of a distal end portion of the example handle shown in FIG. 18.

[0112] FIG. 20 illustrates a cross-sectional view of a mid-portion of the example handle shown in FIG. 18.

[0113] FIG. 21 illustrates example adaptors of actuator assemblies for pull tethers.

[0114] FIG. 22 illustrates a perspective transparent view of an example adaptor for an example actuator assembly.

[0115] FIG. 23 illustrates a perspective transparent view of an example adaptor for an example actuator assembly.

[0116] FIG. 24 illustrates a perspective view of an example plate of the adaptor shown in FIG. 22.

[0117] FIG. 25 illustrates a cross-sectional view of a proximal end portion of the example handle shown in FIG. 18.

[0118] FIG. 26 illustrates a cut-away perspective view of an interior of the example handle shown in FIG. 18.

[0119] FIG. 27 illustrates a side view of the example handle with a portion shown in transparency.

[0120] FIG. 28 illustrates a side view of a distal end portion of the example delivery system shown in FIG. 1.

[0121] FIG. 29 illustrates a side view of the distal end portion of the example delivery system with a portion bent from the configuration shown in FIG. 28.

[0122] FIG. 30 illustrates a top view of the distal end portion of the example delivery system with a portion bent from the configuration shown in FIG. 28.

[0123] FIG. 31 illustrates a side schematic view of the delivery system shown in FIG. 1.

[0124] FIG. 32 illustrates a cross-sectional view of an interior of the example handle of the example delivery system shown in FIG. 1.

[0125] FIG. 33 illustrates a side schematic view of the example delivery system shown in FIG. 31 with depth having been produced.

[0126] FIG. 34 illustrates a cross-sectional view of an interior of the example handle of the example delivery system shown in FIG. 1.

[0127] FIG. 35 illustrates a side schematic view of the example delivery system shown in FIG. 31 with height having been produced.

[0128] FIG. 36 illustrates a perspective view of an example brace for the example delivery system shown in FIG. 1 including an example haptic indicator.

[0129] FIG. 37 illustrates a perspective cut-away view of an interior of an example handle.

[0130] FIG. 38 illustrates a perspective view of the example handle of the example delivery system shown in FIG. 1 with a portion shown in transparency and portions removed from view, including aesthetic features.

[0131] FIG. 39 illustrates a perspective view of the example handle of the example delivery system shown in FIG. 1 with a portion shown in transparency and portions removed from view, including aesthetic features.

[0132] FIG. 40 illustrates a cross-sectional view of an interior of the example handle shown in FIG. 38.

[0133] FIG. 41 illustrates a schematic view of an approach of an example delivery system to an implantation site.

[0134] FIG. 42 illustrates a cut-away view of an example delivery system approaching a tricuspid valve.

[0135] FIG. 43 illustrates a cut-away view of an example delivery system deploying an example treatment device to a tricuspid valve.

[0136] FIG. 44 illustrates a cut-away view of an example treatment device having been deployed to a tricuspid valve.

[0137] FIG. 45 illustrates a perspective schematic view of an arrangement of pull tethers.

[0138] FIG. 46A illustrates a cross-sectional schematic view along line A-A in FIG. 45.

[0139] FIG. 46B illustrates a cross-sectional schematic view along line B-B in FIG. 45.

[0140] FIG. 46C illustrates a cross-sectional schematic view along line C-C in FIG. 45.

[0141] FIG. 46D illustrates a cross-sectional schematic view along line D-D in FIG. 45.

[0142] FIG. 47 illustrates a perspective schematic view of positions of pull tethers within an interior lumen of a rail shaft.

[0143] FIG. 48 illustrates a perspective view of an example tether assembly for an example delivery system.

[0144] FIG. 49 illustrates a cross-sectional schematic view of positions of tethers of the tether assembly of FIG. 48.

[0145] FIG. 50 illustrates a side view of an example delivery system having the example tether assembly of FIG. 48, with the delivery system deflected to produce height.

[0146] FIG. 51 illustrates a perspective view of an example delivery system, including aesthetic features.

[0147] FIG. 52 illustrates a side cross-sectional schematic view of the example delivery system of FIG. 51.

[0148] FIG. 53 illustrates a side cross-sectional schematic view of the example delivery system of FIG. 51 with an example capsule retracted.

[0149] FIG. 54 illustrates a side cross-sectional schematic view of the example delivery system of FIG. 51 with the example delivery system deflected to produce height.

[0150] FIG. 55 illustrates a side view of a precurved shaft for an example delivery system.

[0151] FIG. 56 illustrates an approach of an example delivery system to a tricuspid valve, with the delivery system having the precurved shaft of FIG. 55.

[0152] FIG. 57 illustrates a side view of a precurved shaft for an example delivery system.

[0153] FIG. 58 illustrates a cut-away view of an example delivery system deploying an example treatment device to a tricuspid valve.

[0154] FIG. 59 illustrates a side view of the example delivery system of FIG. 58 deflected to produce height.

[0155] FIG. 60A illustrates a cross-sectional view of an example nose body and example nose body shaft.

[0156] FIG. 60B illustrates a cross-sectional view of the example nose body of FIG. 60A having expanded in size.

[0157] FIG. 61 illustrates a cut-away view of an example delivery system deploying an example treatment device to a tricuspid valve.

[0158] FIG. 62A illustrates a cross-sectional view of an example nose body and an example nose body shaft.

[0159] FIG. 62B illustrates a cross-sectional view of the example nose body of FIG. 62A having expanded in size.

[0160] FIG. 63 A illustrates a cross-sectional view of an example nose body and an example nose body shaft.

[0161] FIG. 63B illustrates a cross-sectional view of the example nose body and example nose body shaft of FIG. 63A with a guide wire passing therethrough.

[0162] FIG. 63C illustrates a cross-sectional view of the example nose body of FIG. 63A engaged with an example guide wire.

[0163] FIG. 64A illustrates a cross-sectional view of an example nose body and an example nose body shaft.

[0164] FIG. 64B illustrates a cross-sectional view of the example nose body and example nose body shaft of FIG. 64A with a guide wire passing therethrough.

[0165] FIG. 64C illustrates a cross-sectional view of the example nose body of FIG. 64A engaged with a guide wire.

[0166] FIG. 65 illustrates a perspective view of an example treatment device illustrated as a prosthetic heart valve.

[0167] FIG. 66 illustrates a cross-sectional schematic view of the example treatment device shown in FIG. 65.

[0168] FIG. 67 illustrates a top view of the example treatment device shown in FIG. 65.

[0169] FIG. 68 illustrates a perspective view of an inner frame of the example treatment device shown in FIG. 65.

[0170] FIG. 69 illustrates a side view of the inner frame of the example treatment device shown in FIG. 65.

[0171] FIG. 70 illustrates a perspective view of an outer frame of the example treatment device shown in FIG. 65.

[0172] FIG. 71 illustrates a side view of the outer frame of the example treatment device shown in FIG. 65, with a portion cut away from view.

[0173] FIG. 72 illustrates a perspective view of a frame of the example treatment device shown in FIG. 65.

[0174] FIG. 73 illustrates a side view of an alignment of an anchor tip and a tip of an elongate beam.

[0175] FIG. 74 illustrates a side schematic view of the outer frame and inner frame of the example treatment device shown in FIG. 65 without the treatment device being fully assembled.

[0176] FIG. 75 illustrates a side view of the outer frame and inner frame of the example treatment device shown in FIG. 65 with the treatment device in a fully assembled state.

[0177] FIG. 76 illustrates a side view of an inner frame.

[0178] FIG. 77 illustrates a partial side view of the inner frame shown in FIG. 76 assembled with an outer frame.

[0179] FIG. 78 illustrates a top cross-sectional schematic view of positions of anchors of an example treatment device.

[0180] FIG. 79 illustrates a perspective view of an example treatment device.

[0181] FIG. 80 illustrates a top cross-sectional schematic view of positions of anchors of the example treatment device shown in FIG. 79.

[0182] FIG. 81 illustrates a side view of an inner frame.

[0183] FIG. 82 illustrates a perspective view of an example treatment device.

[0184] FIG. 83 illustrates a perspective view of an outer frame of the example treatment device shown in FIG. 82.

[0185] FIG. 84 illustrates a perspective view of an inner frame.

[0186] FIG. 85 illustrates a perspective view of an inner frame for use with an example treatment device as shown in FIG. 82.

[0187] FIG. 86 illustrate a perspective view of the inner frame shown in FIG. 85.

[0188] FIG. 87 illustrates a top cross-sectional schematic view of positions of anchors.

[0189] FIG. 88 illustrates a fluoroscopic image of an example delivery system.

[0190] FIG. 89 illustrates a top cross-sectional schematic view of deployment of an example treatment device.

[0191] FIG. 90A illustrates perspective view of an example inner retention member.

[0192] FIG. 90B illustrates a perspective view of an example inner retention member.

[0193] FIG. 91 illustrates a perspective view of an end of an example intermediate shaft.

[0194] FIG. 92 illustrates a perspective view of an example treatment device being crimped or loaded to an intermediate shaft.

[0195] FIG. 93 illustrates a top view of an end of an example intermediate shaft with a covering having been removed.

[0196] FIG. 94 illustrates a perspective view of a proximal end of an example delivery system, with portions removed from view and shown in transparency.

[0197] FIG. 95 illustrates a perspective view of a proximal end of an example delivery system, with portions removed from view and shown in transparency.

[0198] FIG. 96 illustrates a perspective view of an alignment body positioned relative to an example treatment device.

[0199] FIG. 97 illustrates a perspective view of an example alignment body upon a nose body shaft.

[0200] FIG. 98 illustrates a side view of the example alignment body shown in FIG. 97 positioned upon a nose body shaft.

[0201] FIG. 99 illustrates a perspective view of an example alignment body upon a nose body shaft.

[0202] FIG. 100 illustrates a perspective view of the example alignment body shown in FIG. 99.

[0203] FIG. 101 illustrates a perspective view of an example treatment device.

[0204] FIG. 102 illustrates a perspective view of an inner frame for the example treatment device shown in FIG. 101.

[0205] FIG. 103 illustrates a top cross-sectional schematic view of positions of anchors for the example treatment device shown in FIG. 101.

[0206] FIG. 104 illustrates a plan view or flat view of an example pattern for the inner frame shown in FIG. 102.

[0207] FIG. 105 illustrates a detail view of a portion of the inner frame shown in FIG. 102.

[0208] FIG. 106 illustrates a perspective view of an example treatment device.

[0209] FIG. 107 illustrates a side cross-sectional schematic view of a portion of the example treatment device shown in FIG. 106.

[0210] FIGS. 108A-D each illustrate a side view of components of an example insertion assembly for a delivery system.

[0211] FIGS. 109 A-C illustrate a sequence of insertion of an example delivery system utilizing an example insertion assembly as shown in FIGS. 108A-D.

[0212] FIG. 110 illustrates an example clamp for use with a delivery system.

[0213] FIG. I l l illustrates an example rail for use with the clamp shown in FIG. 110.

[0214] FIG. 112 illustrates a perspective view of an example stabilizer table for use with a delivery system.

[0215] FIG. 113 illustrates a perspective view of an example treatment device.

[0216] FIG. 114 illustrates a side schematic view of a portion of the treatment device of FIG.113, with a representation of a frame and a leaflet.

[0217] FIG. 115 illustrates a top cross-sectional schematic view of positions of anchors of the treatment device of FIG. 113.

[0218] FIG. 116 illustrates a close up side view of a tip of an anchor of the treatment device of FIG. 113.

[0219] FIG. 117 illustrates a side schematic view of the treatment device of FIG. 113 in a linearized or compressed configuration.

[0220] FIG. 118 illustrates a side cross-sectional schematic view of a portion of the example treatment device shown in FIG. 113 engaged with a native valve leaflet.

[0221] FIG. 119 illustrates a top cross-sectional schematic view of positions of anchors of an example treatment device.

[0222] FIG. 120 illustrates a top view of an inner frame of the example treatment device shown in FIG. 119.

[0223] FIG. 121 illustrates a perspective view of the inner frame of the example treatment device shown in FIG. 119.

[0224] FIG. 122 illustrates a cross-sectional schematic view of an example treatment device.

[0225] FIG. 123 illustrates a cross-sectional schematic view of the example treatment device of FIG. 122 in a linearized or compressed configuration.

[0226] FIG. 124 illustrates a cross-sectional schematic view of the example treatment device of FIG. 122 in a linearized or compressed configuration.

[0227] FIG. 125 illustrates a cross-sectional schematic view of the example treatment device of FIG. 122 deployed to a native heart valve.

[0228] FIG. 126 illustrates a cross-sectional schematic view of an example treatment device.

[0229] FIG. 127 illustrates a close up perspective view of a release mechanism or release control for the example treatment device of FIG. 126.

[0230] FIG. 128A illustrates a top view of the release mechanism or release control of FIG. 126.

[0231] FIG. 128B illustrates a top view of the release mechanism or release control of FIG. 126 having been released.

[0232] FIG. 129 illustrates a cross-sectional schematic view of the example treatment device of FIG. 126 in a linearized or compressed configuration.

[0233] FIG. 130 illustrates a cross-sectional schematic view of the example treatment device of FIG. 126 in a linearized or compressed configuration.

[0234] FIG. 131 illustrates a cross-sectional schematic view of the example treatment device of FIG. 126 deployed to a native heart valve.

[0235] FIG. 132 illustrates a cross-sectional perspective view of a distal end of a shaft of a delivery system, showing at least a portion of a rotation mechanism and / or rotation control.

[0236] FIG. 133 illustrates a cross-sectional side view of at least the portion of the rotation control shown in FIG. 132.

[0237] FIG. 134 illustrates a perspective view of components of the rotation control shown in FIG. 132, with other components excluded from view.

[0238] FIG. 135 illustrates a perspective view of a component of the rotation control shown in FIG. 132.

[0239] FIG. 136 illustrates a cross-sectional perspective view of at least a portion of the rotation control of FIG. 132.

[0240] FIG. 137 illustrates a cross-sectional perspective view of at least a portion of the rotation control of FIG. 132.

[0241] FIG. 138 illustrates a side view of an example delivery system including aesthetic features thereof.

[0242] FIG. 139 illustrates a perspective view showing at least a portion of a rotation control.

[0243] FIG. 140 illustrates a perspective view showing at least a portion of the rotation control of FIG. 139.

[0244] FIG. 141 illustrates a side view showing at least a portion of the rotation control of FIG. 139.

[0245] FIG. 142 illustrates a cross-sectional perspective view showing at least a portion of the rotation control of FIG. 139.

[0246] FIG. 143 illustrates a side view showing at least a portion of a rotation control.

[0247] FIG. 144 illustrates a perspective view showing at least a portion of the rotation control of FIG. 143.

[0248] FIG. 145 illustrates a perspective view showing at least a portion of the rotation control of FIG. 143.

[0249] FIG. 146 illustrates a perspective view of an example displacement mechanism.

[0250] FIG. 147 illustrates a perspective view of the example displacement mechanism of FIG.146.

[0251] FIG. 148 illustrates a perspective view of a proximal end portion of a delivery system.

[0252] FIG. 149 illustrates a perspective view of a proximal end portion of a delivery system.

[0253] FIG. 150 illustrates a perspective view of the proximal end portion of the delivery system shown in FIG. 149 at a reverse angle than shown in FIG. 149.

[0254] FIG. 151 illustrates a cross-sectional view of the delivery system shown in FIG. 149.

[0255] FIG. 152 illustrates a cross-sectional view of the delivery system shown in FIG. 149, with a housing of the delivery system being rotated relative to another housing of the delivery system.

[0256] FIG. 153 illustrates a cross-sectional view of a distal portion of a delivery system.

[0257] FIG. 154 illustrates a cross-sectional view of a portion of an example delivery system including a rotation control.

[0258] FIG. 155 illustrates a side view of an example delivery system including the rotation control of FIG. 154.

[0259] FIG. 156 illustrates a cross-sectional schematic view of the rotation control of FIG. 154.

[0260] FIG. 157 illustrates a cross-sectional schematic view of rotation of the example rotation control of FIG. 156.

[0261] FIG. 158 illustrates a cross-sectional view of at least a portion of a rotation control of an example delivery system.

[0262] FIG. 159 illustrates a side view of an example delivery system including the rotation control of FIG. 158.

[0263] FIG. 160 illustrates a side view of the example delivery system of FIG. 159.

[0264] FIG. 161 illustrates a cross-sectional perspective view of at least a portion of the rotation control of FIG. 158.

[0265] FIG. 162 illustrates a cross-sectional perspective view of a portion of an example rotation control.

[0266] FIG. 163 illustrates a perspective view of a portion of the rotation control of FIG. 162.

[0267] FIG. 164 illustrates a cross-sectional view of rotation of the rotation control as represented in FIGS. 162 and 163.

[0268] FIG. 165 illustrates a cross-sectional perspective view of a portion of a rotation control.

[0269] FIG. 166 illustrates a perspective view of a portion of the rotation control of FIG. 165.

[0270] FIG. 167 illustrates a cross-sectional schematic view of at least a portion of a rotation control.

[0271] FIG. 168 illustrates a cross-sectional schematic view of at least a portion of a rotation control of FIG. 167 having been rotated.

[0272] FIG. 169 illustrates a cross-sectional schematic view of at least a portion of a rotation control.

[0273] FIG. 170 illustrates a cross-sectional schematic view of at least a portion of a rotation control.

[0274] FIG. 171 illustrates a cross-sectional schematic view of at least a portion of a rotation control of FIG. 170 having been rotated.

[0275] FIG. 172 illustrates a cross-sectional schematic view of at least a portion of a rotation control .

[0276] FIG. 173 illustrates a cross-sectional schematic view of at least a portion of a rotation control of FIG. 172 having been rotated.

[0277] FIG. 174 illustrates a side view of an example delivery system.

[0278] FIG. 175 illustrates a side cross-sectional view of a rotation control of the delivery system of FIG. 174.

[0279] FIG. 176 illustrates a side cross-sectional view of a rotation control of the delivery system of FIG. 174.

[0280] FIG. 177 illustrates a perspective view of an actuator assembly of an example delivery system.

[0281] FIG. 178 illustrates a side view of a delivery system including the actuator assembly shown in FIG. 177.

[0282] FIG. 179 illustrates a cross-sectional view of the delivery system of FIG. 177.

[0283] FIG. 180 illustrates a schematic longitudinal cross-sectional view of a portion of the delivery system of FIG. 177.

[0284] FIG. 181 illustrates a side view of an example delivery system.

[0285] FIG. 182 illustrates a cross-sectional view of an example delivery system.

[0286] FIG. 183 illustrates a schematic longitudinal cross-sectional view of a portion of the delivery system of FIG. 182.

[0287] FIG. 184 illustrates a side view of an example delivery system.

[0288] FIG. 185 illustrates a cross-sectional view of the example delivery system of FIG. 184.

[0289] FIG. 186 illustrates a cross-sectional view of the example delivery system of FIG. 184 with an actuator assembly pressed.

[0290] FIG. 187 illustrates a side view of a portion of the actuator assembly shown in FIG. 185.

[0291] FIG. 188 illustrates a cross-sectional view of an example delivery system.

[0292] FIG. 189 illustrates a cross-sectional view of an example delivery system.

[0293] FIG. 190 illustrates a cross-sectional view of a proximal end portion of an example delivery system.

[0294] FIG. 191 illustrates a perspective view of a tether assembly of an example rail shaft.

[0295] FIG. 192A illustrates a perspective schematic view of the rail shaft of FIG. 191.

[0296] FIG. 192B illustrates an end schematic view of the rail shaft of FIG. 191.

[0297] FIG. 193 illustrates a schematic view of the tether assembly of FIG. 191.

[0298] FIG. 194 illustrates a schematic view of the tether assembly of FIG. 191, deflected from the position shown in FIG. 193.

[0299] FIG. 195 illustrates a schematic view of the rail shaft of FIG. 191, deflected from the position shown in FIG. 193.

[0300] FIG. 196 illustrates a schematic view of an example tether assembly.

[0301] FIG. 197 illustrates a schematic view of the tether assembly of FIG. 196, deflected from the position shown in FIG. 196.

[0302] FIG. 198 illustrates a schematic view of the tether assembly of FIG. 196, deflected from the position shown in FIG. 196.

[0303] FIG. 199 illustrates a perspective view of a tether assembly of an example rail shaft.

[0304] FIG. 200 illustrates a schematic view of an example tether assembly.

[0305] FIG. 201 illustrates a schematic view of the tether assembly of FIG. 200, varied from the position shown in FIG. 200.

[0306] FIG. 202 illustrates a schematic view of the tether assembly of FIG. 200, varied from the position shown in FIG. 200.DETAILED DESCRIPTION

[0307] The present specification and drawings provide aspects and features of the disclosure in the context of several examples of devices, systems, methods, etc. that can be used to treat a subject (e.g., a living subject, a simulation, etc.). In some implementations, the devices, systems, methods, etc. are configured to be useable in the vasculature of a patient, such as for repair or replacement of native valves in a patient. These examples may be discussed in connection with treating, repairing, replacing, etc. specific valves such as the patient’s aortic, tricuspid, or mitral valve. However, it is to be understood that the features and concepts discussed herein can be applied to other devices, systems, and products other than heart valve devices. For example, the controlled positioning, deployment, and securing features described herein can be applied to other types of medical treatment devices and implants, for example other types of expandable prostheses, for use elsewhere in the body, such as within an artery, a vein, or other body cavities or locations.

[0308] Additionally, particular features of a device, valve, system, etc. should not be taken as limiting, and features of any one example discussed herein can be combined with features of other examples as desired and when appropriate. While some of the examples described herein are described in connection with a transfemoral delivery approach, it should be understood that these examples can be used for other delivery approaches such as, for example, transapical approaches, transjugular approaches, etc. Moreover, some of the features described in connection with someimplementations herein can be incorporated with other implementations, including those which arc described in connection with different delivery approaches.

[0309] FIG. 1 illustrates an example of a device, assembly, or system 10, which can be used for delivery of a treatment device (e.g., implant, prosthetic valve, repair device, etc.). The delivery system 10 can be used to deploy a treatment device (e.g., implant, prosthesis, replacement heart valve, repair device, etc.) within a body of a subject (e.g., a living subject, a simulation, etc.). Replacement heart valves can be delivered to a patient’s tricuspid heart valve annulus or other heart valve location in various manners, such as by open surgery, minimally-invasive surgery, and percutaneous or transcatheter delivery through the patient’ s vasculature.

[0310] Example transfemoral approaches may be found in U.S. Pat. Pub. No. 2015 / 0238315, filed February 20, 2015, the entirety of which is hereby incorporated by reference in its entirety. While the delivery system 10 is described in connection with a percutaneous delivery approach, and more specifically a transfemoral delivery approach, it should be understood that features of the delivery system 10 can be applied to other delivery systems, including delivery systems used or adapted for a transapical delivery approach, etc.

[0311] As shown in FIG. 1, the delivery system 10 can include an elongate shaft or shaft assembly 12 comprising a proximal end portion 11 and a distal end portion 13. A housing or handle 14 is coupled to the proximal end portion 11 of the elongate shaft assembly 12. The elongate shaft assembly 12 can be used to hold a treatment device (e.g., implant, prosthesis, prosthetic valve, repair device, etc.) for advancement of the treatment device through a patient’s vasculature to a treatment location. For example, as shown in FIG. 17, the elongate shaft assembly 12 can include a device retention area 16 for retaining the treatment device.

[0312] The device retention area 16 can be positioned at the distal end portion 13 of the elongate shaft assembly 12. The elongate shaft assembly 12 can hold a treatment device, such as an implant or expandable prosthesis, in a compressed state at the device retention area 16 for advancement of the device within the body.

[0313] The elongate shaft assembly 12 can then be used to allow controlled expansion of the treatment device at the treatment location. In some implementations, the elongate shaft assembly 12 may be used to allow for sequential controlled expansion of the device. The device retentionarea 16 is shown in FIG. 17 at the distal end portion of the delivery system, but can also be at other locations.

[0314] The elongate shaft or shaft assembly 12 can include one or more shafts, sheaths, or subassemblies in some implementations. The shafts, sheaths, or subassemblies can be arranged to surround or cover other shafts, sheaths, or subassemblies positioned radially inward. The shafts, sheaths, or subassemblies can be positioned concentric with each other. The shafts, sheaths, or subassemblies can include one, some, or all of: an outer sheath assembly 22 (represented in FIG. 2), an intermediate shaft or mid shaft assembly 21 (represented in FIG. 3), a rail shaft assembly 20 (represented in FIG. 4), an inner shaft assembly 18 (represented in FIG. 5), and / or a nose body assembly 31 (represented in FIG. 6). In some implementations, the delivery system 10 may not have all of the assemblies disclosed herein. For example, a full intermediate shaft or mid shaft assembly, or another shaft assembly, may not be incorporated into the delivery system 10 in some implementations. In some implementations, the assemblies can be in a different radial order than is discussed.

[0315] An arrangement of sheaths, shafts, or assemblies of a delivery system are disclosed in International Application No. PCT / US2020 / 054786, with an international filing date of October 8, 2020, and published as WO / 2021 / 080782, and titled “SYSTEMS AND METHODS FOR TRICUSPID VALVE TREATMENT,” the entire contents of which are incorporated herein by reference. Features of the sheaths, shafts, or assemblies of a delivery system disclosed in International Application No. PCT / US2020 / 054786 can be incorporated with and may be applied to and utilized with the features of delivery systems disclosed herein as desired.

[0316] FIG. 2 illustrates a perspective view of an example outermost assembly in the form of outer sheath assembly 22. The outer sheath assembly 22 can include an outer sheath 32 including multiple components. The outer sheath 32 can include an outer proximal shaft 34 that is attached to the handle 14 at a proximal end of the outer proximal shaft 34.

[0317] In some implementations, the outer sheath 32 includes a flexible section or hypotube section 36 having a proximal end coupled to a distal end of the outer proximal shaft 34.

[0318] In some implementations, the outer sheath 32 can include a capsule 38 having a proximal end coupled to a distal end of the flexible section or hypotube section 36. In someimplementations, the capsule 38 can be formed as one-piece integral with the hypotube section 36, or the capsule 38 and hypotubc section 36 may comprise separate parts joined together.

[0319] In some implementations, the outer sheath assembly 22 can comprise or include the distal end portion 13 of the elongate shaft assembly 12. In some implementations, the components of the outer sheath assembly 22 can form a lumen for the other subassemblies to pass through.

[0320] In some implementations, the outer proximal shaft 34 comprises a tube including an interior lumen for interior subassemblies to pass through. In some implementations, the outer proximal shaft 34 can include an inner shaft 35 or sheath and an outer shaft 37 or sheath extending over the inner shaft 35 or sheath. The outer shaft 37 is shown in partial cut-away.

[0321] In some implementations, the outer shaft 37 may comprise a tubing positioned over the inner shaft 35. The tubing may comprise shrink tubing or heat shrink tubing in some implementations. Fluorinated ethylene-propylene (FEP) or other forms of tubing may be utilized in some implementations. The tubing may provide rigidity, tensile strength, and a seal to block fluid pathways through any cuts in the inner shaft 35.

[0322] The outer proximal shaft 34 may be flexible and adapted to deflect in one or more planes during advancement and manipulation of the elongate shaft or shaft assembly 12. The inner shaft 35 of the outer proximal shaft 34 may include one or more cuts along its surface for enhancing a flexibility of the outer proximal shaft 34 in some implementations. A cut pattern may comprise a universal cut pattern allowing for flexibility in all directions in some implementations. Other forms of cut patterns may be utilized in some implementations.

[0323] In some implementations, the outer proximal shaft 34 may include a marker on a proximal end that notifies a user of the position of the outer sheath assembly 22 on its distal end relative to other shafts, sheaths, or subassemblies. In some implementations, such a marker may be excluded. In some implementations, the outer proximal shaft 34 may include keyed cutouts on the proximal end of outer proximal shaft 34 to allow for connection to the handle 14 while maintaining correct orientation of the outer proximal shaft 34 through the elongate shaft assembly 12.

[0324] In some implementations, the flexible section or hypotube section 36 can be a hypotube which in some implementations may be cut or have slots, as discussed in detail below. In someimplementations, the flexible section or hypotube section 36 can be covered or encapsulated with a layer of cPTFE, PTFE, or other polymcr / matcrial so that the outer surface of the flexible section or hypotube section 36 is generally smooth. Further an inner surface of the flexible section or hypotube section 36 may be covered to be generally smooth. In some implementations, the hypotube section 36 may also be formed using a coiled or braided wire to maintain its shape and radial strength, while allowing for flexibility of the hypotube section 36.

[0325] In some implementations, the capsule 38 is adapted to cover a treatment device positioned within the device retention area 16 (marked in FIG. 17). The capsule 38 surrounds the device retention area 16. In some implementations, the capsule has sufficient strength to retain the device in a compressed configuration and prevent expansion of the device within the device retention area 16. In some implementations, the capsule 38 further has sufficient strength to be retracted relative to the device to release the device from the device retention area 16.

[0326] In some implementations, the capsule 38 can be a tube formed of a plastic or metal material. In some implementations, the capsule 38 is formed of ePTFE or PTFE. In some implementations, the capsule 38 may include reinforcement layers or tie layers between the inner surface and outer surface of the capsule 38 to provide more strength to maintain device radial compression. A coiled or braided wire, or laser cut hypotube, or radially strong polymer may be used.

[0327] In some implementations, the capsule 38 is relatively thick to prevent tearing and to help maintain a self-expanding device in a compressed or compacted configuration within the device retention area 16. In some implementations the material of the capsule 38 is the same material as the coating on the flexible section or hypotube section 36. In some implementations, the capsule 38 may be formed as one-piece integral with the hypotube section 36. As shown in FIG. 2, the capsule 38 can have a diameter larger than the flexible section or hypotube section 36, though in some implementations the capsule 38 may have a similar diameter as the flexible section or hypotube section 36. In some implementations, there may be a step or a taper between the two portions.

[0328] In some implementations, the outer sheath assembly 22 is configured to be individually slidable with respect to the other assemblies. In some implementations, the outer sheath assembly 22, for example, is configured to be retracted with respect to the other assemblies to retract thecapsule 38 from the device retention area 16 to release the device positioned therein. In some implementations, the outer sheath assembly 22 has sufficient tensile strength to be retracted relative to the other assemblies for release of the device from the device retention area 16.

[0329] Further, in some implementations, the outer sheath assembly 22 can slide distally and proximally relative to other components, e.g., relative to one or more of a rail shaft assembly 20, intermediate / mid shaft assembly 21, inner shaft assembly 18, and / or nose body assembly 31.

[0330] In some implementations, the system includes an intermediate shaft or mid shaft assembly 21. Moving radially inwardly from the outer sheath assembly 22, in some implementations, the next assembly is the intermediate shaft or mid shaft assembly 21. FIG. 3 shows a similar view as FIG. 2, but with the outer sheath assembly 22 removed, thereby exposing the intermediate or mid shaft assembly 21.

[0331] In some implementations, the intermediate or mid shaft assembly 21 can include an intermediate sheath or shaft 40 including multiple components. In some implementations, the intermediate shaft 40 can include a proximal tube 42 that can be attached at its proximal end to the handle 14. In some implementations, the intermediate shaft 40 can include a flexible section or hypotube section 44 that is attached to a distal end of the proximal tube 42. In some implementations, an outer retention member or ring 46 (or inner capsule) is positioned at the distal end of the flexible section or hypotube section 44. These components of the intermediate shaft 40 can form a lumen for other subassemblies to pass through.

[0332] In some implementations, the proximal tube 42 comprises a tube including an interior lumen for interior subassemblies to pass through. The proximal tube 42 may include an inner shaft 43 or sheath and an outer shaft 45 or sheath extending over the inner shaft 43 or sheath. The outer shaft 45 is shown in partial cut-away.

[0333] In some implementations, the outer shaft 45 may comprise a tubing positioned over the inner shaft 43. The tubing may comprise shrink tubing or heat shrink tubing in some implementations. Fluorinated ethylene-propylene (FEP) or other forms of tubing may be utilized in some implementations. The tubing may provide rigidity, tensile strength, and a seal to block fluid pathways through any cuts in the inner shaft 43.

[0334] In some implementations, the proximal tube 42 may be flexible and adapted to deflect in one or more planes during advancement and manipulation of the elongate shaft or shaft assembly 12. The proximal tube 42 may include one or more cuts along its surface for enhancing a flexibility of the proximal tube 42 in some implementations. A cut pattern can comprise a universal cut pattern allowing for flexibility in all directions in some implementations. Other forms of cut patterns may be utilized in some implementations.

[0335] In some implementations, the proximal tube 42 may include keyed cutouts on the proximal end of the proximal tube 42 to allow for connection to the handle 14 while maintaining correct orientation of the intermediate or mid shaft assembly 21 through the elongate shaft assembly 12.

[0336] In some implementations, the outer retention member or ring 46 (or inner capsule) can be configured as a device retention mechanism that can be used to engage with the device. For example, the outer retention member or ring 46 may be a ring or covering that is configured to radially cover a proximal end portion of the device. Referring to FIG. 17, the outer retention member or ring 46 can also be considered to be part of the device retention area 16, and may be at the proximal end of the device retention area 16. In some implementations, the outer retention member or ring 46 may be selectively retracted to release the device from an inner retention member 50 during deployment of the device. The outer retention member or ring 46 is shown in FIG. 9 with an outer covering removed. The outer retention member or ring 46 may include a hypotube with a cut pattern, and having an interior liner and outer covering (excluded from view in FIG. 9).

[0337] Referring to FIG. 9, in some implementations, the flexible section or hypotube section 44 is positioned longitudinally between the proximal tube 42 and the outer retention member or ring 46. The hypotube section 44 can include a plurality of cuts that allow for deflection or bending of the intermediate or mid shaft assembly 21 in directions corresponding to the deflection or bending of the rail shaft assembly 20. In some implementations, the hypotube section 44, for example, can be positioned radially between the outer sheath 32 and the rail shaft assembly 20 and accordingly can deflect according to the movement of the rail shaft assembly 20.

[0338] In some implementations, portions of the hypotube section 44 may be configured to deflect in one or more different directions to account for the directions of movement of the rail shaft assembly 20.

[0339] FIG. 9, for example, illustrates an isolated view of the example intermediate or mid shaft assembly 21. FIG. 10 illustrates a flat pattern of the flexible section or hypotube section 44 with portions of the hypotube section 44 corresponding to different directions of deflection bound within broken lines. A first section 48 (bound by dot-dot lines) for example, has a cut pattern corresponding to the distal or primary bend portion 60 (marked in FIG. 12) of the rail shaft assembly 20. In some implementations, the first section 48 may include cuts that are aligned longitudinally with each other to allow for deflection of the first section 48 in the direction provided by the distal or primary bend portion 60 of the rail shaft assembly 20. The position of such an area along the hypotube section 44 is marked in FIG. 3.

[0340] In some implementations, a second section 52 (bound by dot-dash lines) has a cut pattern corresponding to the intermediate or secondary bend portion 62 (marked in FIG. 12) of the rail shaft assembly 20. In some implementations, the second section 52 may include cuts that are aligned longitudinally with each other to allow for deflection of the second section 52 in the direction provided by the intermediate or secondary bend portion 62 of the rail shaft assembly 20. In some implementations, the cuts of the second section 52 are interleaved with the cuts of the first section 48 for a portion of the first section 48. For example, the cuts of the second section 52 alternate with the cuts of the first section 48, yet are circumferentially or rotationally offset from the position of the cuts of the first section 48. In some implementations, the cuts of the second section 52 are similarly interleaved and offset with the cuts of the fourth section 54.

[0341] In some implementations, a third section 53 (bound by dash-dash lines) has a cut pattern corresponding to the distal or primary bend portion 60, the intermediate or secondary bend portion 62, and the proximal or height bend portion 64. In some implementations, the cuts of the third section 53 comprise an interleaving of the cuts from the first section 48, the second section 52, and the fourth section 54. In some implementations, the third section 53 exists at the transition between the second section 52 and fourth section 54. In some implementations, the third section 53 allows deflection of the hypotube section 44 in any of the orientations of the three bend portions 60, 62,or 64. This is due to relative longitudinal position of the hypotube section 44 relative to the rail shaft assembly 20.

[0342] In some implementations, a fourth section 54 (bound by dot-dot-dash lines) has a cut pattern corresponding to the proximal or height bend portion 64 (marked in FIG. 12) of the rail shaft assembly 20. In some implementations, the fourth section 54 may include cuts that are aligned longitudinally with each other to allow for deflection of the fourth section 54 in the direction provided by the proximal or height bend portion 64 of the rail shaft assembly 20.

[0343] In some implementations, the cuts of the fourth section 54 are interleaved with the cuts of the second section 52 for a portion of the fourth section 54. For example, the cuts of the fourth section 54 alternate with the cuts of the second section 52, yet are circumferentially or rotationally offset from the position of the cuts of the second section 52 (with a portion of the fourth section 54 shown to one side of FIG. 10 wrapping to continue with the portion on the other side of FIG. 10). FIG. 9, for example, indicates the position of the fourth section 54 along the hypotube section 44.

[0344] In some implementations, the lengths of the sections 48, 52, 53, 54 are configured to account for a longitudinal sliding movement of the intermediate or mid shaft assembly 21 relative to the rail shaft assembly 20. For example, during a sliding movement of the intermediate or mid shaft assembly 21 to vary depth of the distal end portion 13 of the elongate shaft or shaft assembly 12, the respective sections 48, 52, 54 may continue to be positioned at the respective bend portions 60, 62, 64 of the rail shaft assembly 20.

[0345] In some implementations, the cuts of the sections 48, 52, 53, 54 may be configured with a wide cut portion 70 positioned circumferentially adjacent to a narrow-cut portion 72. FIG. 11 A, for example, illustrates a close-up view of a juncture of a wide cut portion 70 with a narrow cut portion 72. In some implementations, a spine or connector portion 74 is positioned between the wide cut portion 70 and the narrow-cut portion 72 and joins the longitudinally distal and proximal portions of the tube together. As shown in FIG. 11 A, the narrow-cut portion 72 may include a teardrop or triangular cut portion 76 adjacent to the connector portion 74. The wide cut portion 70 may include an oval or curved oblong cut portion 78 adjacent to the connector portion 74 and on an opposite side of the connector portion 74 from the triangular cut portion 76. The oblong cut portion 78 may extend to a V-shaped wedge forming the wide cut portion 70 and thetriangular cut portion 76 may extend to a generally thin or linear cut extending away from the connector portion 74. Variations in the configuration of the connector portion 74 and adjoining sections may be provided in some implementations.

[0346] FIG. 11B, for example, illustrates an example in which the connector portion 80 includes a bump 82 extending towards the wide cut portion 84 of the hypotube, thus forming a forked shape 86 in the cut pattern adjacent to the bump 82. The narrow cut portion 88 may include an oblong cut portion 90 similar- to the oblong cut portion 78 shown in FIG. 11 A. Other variations can be provided or used. A use of a bump 82 may improve stress distribution of the hypotube.

[0347] FIG. 11C, for example, illustrates an example in which the connector portion 92 includes a bump 94 extending towards the narrow cut portion 96 of the hypotube, thus forming a forked shape 98 in the cut pattern adjacent to the bump 94. In some implementations, the connector portion 92 may include a “V” shaped indentation 100 on the opposite side of the connector portion 92, thus forming a spade or diamond shaped cut 102 adjacent to the connector portion 92. In some implementations, the spade or diamond shaped cut 102 may extend to the wide cut portion 104 of the hypotube. Other variations may be provided. The connector portion 92 has a “V” shape. Such a configuration may reduce stress and strain on the hypotube.

[0348] FIG. 11D illustrates an implementation in which both sides of the connector portion 106 include respective bumps 108, 110. The bumps 108, 110 produce forked shapes in the cut pattern adjacent to the bumps. Such a configuration may be utilized in a “universal” spine configuration that may allow for relief in multiple directions.

[0349] The configurations represented in FIGS. 11A-1 ID may be utilized in any hypotube or cut pattern or other example disclosed herein.

[0350] Other variations in the configuration of an intermediate shaft or mid shaft assembly 21 may be utilized in some implementations. FIGS. HE and HF, for example, illustrate a configuration of a cut pattern for an outer retention member or ring 111 that may be utilized in some implementations. The outer retention member or ring 111 may be configured similarly as the outer retention member or ring 46 unless stated otherwise. A first side of the outer retention member or ring 111 is shown in FIG. HE. The side may include a cut pattern having circumferentially extending locking cuts 113 in some implementations. The opposite side (shown in FIG. 1 IF) may include a cut pattern 115 including elongate circumferentially extending cuts117 alternated with short slot cuts 1 19. The hypotube shown in FIGS. 11 E and 1 1 F may be covered with a sheath, shroud, or coating as desired.

[0351] FIGS. 11G and 11H illustrates an example in which the portion 121 of the cut pattern of the hypotube 123 that does not overlap or interleave with the second section 125 has a shorter length than shown in FIG. 10. The corresponding first section 127, second section 125, third section 129, and fourth sections 131 are marked in FIG. 11H, corresponding to the respective sections 48, 52, 53, 54 marked in FIG. 10. A cut pattern as shown in FIGS. 11G and 11H may be utilized as desired.

[0352] Referring to FIG. 3, in some implementations, the intermediate shaft or mid shaft assembly 21 is configured to be individually slidable with respect to the other assemblies. In some implementations, the intermediate shaft or mid shaft assembly 21, for example, is configured to be retracted with respect to the other assemblies to retract the outer retention member or ring 46 from the device retention area 16 to release the device positioned therein. In some implementations, the intermediate shaft or mid shaft assembly 21 has sufficient tensile strength to be retracted relative to the other assemblies for release of the device from the device retention area 16. Further, in some implementations, the intermediate shaft or mid shaft assembly 21 can slide distally and proximally relative to the rail shaft assembly 20 together with the outer sheath assembly 22, the inner shaft assembly 18, and nose body assembly 31.

[0353] In some implementations, a spacer sleeve component may be positioned within the flexible section or hypotube section 44. The spacer sleeve component may comprise a multi-layer lumen positioned within the hypotube section 44. In some implementations, the spacer sleeve component comprises a slick polymer layer on the inner and outer surfaces, with a braided wire in the middle for strength. The spacer sleeve component may provide structure to the hypotube section 44 and may reduce friction between the mid shaft assembly 21 and the rail shaft assembly 20.

[0354] In some implementations, a rail shaft assembly can optionally be included. Moving radially inwardly in the illustrated example, the next assembly comprises a rail shaft assembly 20. FIG. 4 shows a similar view as FIG. 3, but with the intermediate shaft or mid shaft assembly 21 removed, thereby exposing the rail shaft assembly 20.

[0355] In some implementations, the rail shaft assembly 20 can include a rail shaft 120 (or rail) generally attached at its proximal end to the handle 14. In some implementations, the rail shaft 120 can be made up of a rail proximal shaft 122 directly attached to the handle 14 at a proximal end and the bend portions 60, 62, 64 attached to the distal end of the rail proximal shaft 122. In some implementations, the rail proximal shaft 122 may be relatively stiff as compared to the bend portions 60, 62, 64, yet in some implementations may allow for flexibility in all directions to facilitate tracking through patient anatomy. In some implementations, the operation and construction of the bend portions 60, 62, 64 is further detailed in regard to FIGS. 12-16 and further in this application.

[0356] In some implementations, the rail proximal shaft 122 comprises a tube including an interior lumen for interior subassemblies to pass through. In some implementations, the rail proximal shaft 122 may include an inner shaft 137 or sheath and an outer shaft 135 or sheath extending over the inner shaft 137 or sheath. The outer shaft 135 is shown in partial cut-away.

[0357] In some implementations, the outer shaft 135 may comprise a tubing positioned over the inner shaft 137. In some implementations, the tubing may comprise shrink tubing or heat shrink tubing in some implementations. Fluorinated ethylene-propylene (FEP) or other forms of tubing may be utilized in some implementations. The tubing may provide rigidity, tensile strength, and a seal to block fluid pathways through any cuts in the inner shaft 137.

[0358] In some implementations, the distal end of the rail shaft 120 (or rail) can abut a proximal end of the inner retention member 50, as shown in FIG. 4.

[0359] In some implementations, the rail shaft 120 comprises a tube including an interior lumen for interior subassemblies to pass through. The rail shaft 120 can slide distally and proximally relative to the other assemblies (the outer sheath assembly 22, the intermediate shaft or mid shaft assembly 21, the inner shaft assembly 18, and nose body assembly 31) to vary a depth of the distal end portion 13 of the elongate shaft or shaft assembly 12. In some implementations, the rail shaft 120 may be fixed in position, with the other assemblies sliding along the rail shaft 120 and thus the rail shaft 120 slides relative to such other assemblies.

[0360] In some implementations, an inner shaft assembly 18 is included. Moving radially inwards in the illustrated example, the next assembly is the inner shaft assembly 18. FIG. 5 showsapproximately the same view as FIG. 4, but with the rail shaft assembly 20 removed, thereby exposing the inner shaft assembly 18.

[0361] In some implementations, the inner shaft assembly 18 can include an inner shaft 130 generally attached at its proximal end to the handle 14. In some implementations, the inner retention member 50 is located at the distal end of the inner shaft 130. In some implementations, the inner shaft 130 can be made of an inner proximal shaft 132 directly attached to the handle 14 at a proximal end and a distal section 134 attached to the distal end of the inner proximal shaft 132. In some implementations, the inner retention member 50 can thus be attached generally at the distal end of the distal section 134. The inner shaft 130 can form a lumen for the other subassemblies to pass through.

[0362] In some implementations, the inner proximal shaft 132 can comprise a tube. The tube can be a single piece tube, or multiple pieces connected together. In some implementations, a tube comprising multiple pieces can provide different characteristics along different sections of the tube, such as rigidity and flexibility. In some implementations, the distal section 134 can be a metal hypotube which in some implementations may be cut or have slots. In some implementations, the distal section 134 can be covered or encapsulated with a layer of ePTFE, PTFE, or other material so that the outer surface of the distal section 134 is generally smooth. The distal section 134 may comprise a braid material in some implementations. The distal section 134 may comprise a cable formed using multiple wire filars, shaped to include a lumen in the middle of the cable.

[0363] In some implementations, the inner retention member 50 can be configured as a device retention mechanism that can be used to engage with the device. For example, the inner retention member 50 may be a ring and can include a plurality of slots configured to engage with struts on the device. The inner retention member 50 can also be considered to be part of the device retention area 16, and may be at the proximal end of the device retention area 16 (as shown in FIG. 17). With struts or other parts of a device engaged with the inner retention member 50, the outer retention member or ring 46 of the intermediate shaft 40 can cover both the treatment device and the inner retention member 50 to secure the device on the delivery system 10. Thus, the device can be sandwiched between the inner retention member 50 of the inner shaft assembly 18 and theouter retention ring 46 of the intermediate shaft 40. Features of such an arrangement disclosed in International Application No. PCT / US2020 / 054786 may be utilized herein.

[0364] In some implementations, the inner shaft assembly 18 is disposed so as to be individually slidable with respect to the other assemblies. Further, the inner shaft assembly 18 can slide distally and proximally relative to the rail shaft assembly 20 together with the outer sheath assembly 22, intermediate shaft or mid shaft assembly 21, and nose body assembly 31.

[0365] In some implementations, a nose body assembly 31 is included. Moving further inwardly from the inner shaft assembly 18 in the illustrated example is an example nose body assembly 31 shown in FIG. 6. In some implementations, the nose body assembly 31 may include a nose body shaft 140, and may have a nose body 142 on its distal end.

[0366] In some implementations, the nose body shaft 140 may include a lumen sized and configured to slidably accommodate a guide wire so that the delivery system 10 can be advanced over the guide wire through the vasculature. However, examples of the system 10 discussed herein may not use a guide wire and thus the nose body shaft 140 can be solid. In some implementations, the nose body shaft 140 may be connected from the nose body 142 to the handle 14, or may be formed of different segments such as the other assemblies. Further, the nose body shaft 140 can be formed of different materials, such as plastic or metal, similar to those described in detail above.

[0367] FIG. 7 illustrates a distal end view of the nose body 142. In some implementations, the nose body 142 may comprise a leading end or tip of the elongate shaft or shaft assembly 12 that leads entry into the patient’s vasculature. In some implementations, the nose body 142 may have a dome shape to improve atraumatic passage through the vasculature of the patient. FIG. 8, for example, illustrates a cross-sectional view of the nose body 142 showing the dome profile of the nose body 142. The interior lumen 144 of the nose body shaft 140 is illustrated. In some implementations, the interior lumen 144 extends through the nose body 142 such that the nose body 142 and nose body shaft 140 may slide along a guide wire positioned within the interior lumen 144.

[0368] In some implementations, the nose body assembly 31 is disposed so as to be individually slidable with respect to the other assemblies. Further, the nose body assembly 31 can slide distally and proximally relative to the rail shaft assembly 20 together with the outer sheath assembly 22, intermediate shaft or mid shaft assembly 21, and inner shaft assembly 18.

[0369] FIG. 12 illustrates a perspective view of the rail shaft 120 isolated from the other shafts of the elongate shaft or shaft assembly 12. The respective bend portions 60, 62, 64 arc positioned in series with each other longitudinally along the length of the elongate shaft or shaft assembly 12.

[0370] In some implementations, the distal or primary bend portion 60 is positioned at the distal end of the rail shaft 120. In some implementations, the distal or primary bend portion 60 includes a distal or primary connector insert 150 and a distal or primary tube section 152 positioned proximal of the primary connector insert 150. In some implementations, the primary tube section 152 has a plurality of cuts 154 for allowing bending in a first direction or first plane of movement.

[0371] FIG. 15 illustrates a perspective view of the distal or primary connector insert 150 with the distal or primary tube section 152 excluded from view. In some implementations, the primary connector insert 150 includes a flattened recess or slot 156 that is shaped to receive a tab 158 (marked in FIG. 12) protruding from an end of the distal or primary tube section 152. In some implementations, the tab 158 and slot 156 configuration may aid during assembly to provide a desired rotational alignment between the distal or primary connector insert 150 and the distal or primary tube section 152. Further, referring to FIG. 15, the primary connector insert 150 may include a counter bore or annular recess 159 for providing concentric alignment between the primary connector insert 150 and the distal or primary tube section 152.

[0372] Referring to FIG. 12, the intermediate or secondary bend portion 62 is positioned proximal of the distal or primary bend portion 60 of the rail shaft 120. In some implementations, the intermediate or secondary bend portion 62 includes an intermediate or secondary connector insert 160 and an intermediate or secondary tube section 162 positioned proximal of the secondary connector insert 160. In some implementations, the secondary tube section 162 has a plurality of cuts 164 for allowing bending in a second direction or second plane of movement.

[0373] In some implementations, the second direction or second plane of movement is transverse to the direction of movement of the distal or primary bend portion 60. In some implementations, the second direction or second plane of movement may be perpendicular to the direction of movement of the distal or primary bend portion 60. In some implementations, two planes of movement may be provided by the distal or primary bend portion 60 and the intermediate or secondary bend portion 62. In some implementations, the directions of the planes of movement may be at varied other angles relative to each other as desired.

[0374] FIG. 15 illustrates a perspective view of an example intermediate or secondary connector insert 160 with the intermediate or secondary tube section 162 excluded from view. In some implementations, the intermediate or secondary connector insert 160 includes a flattened recess or slot 166 that is shaped to receive a tab 167 (marked in FIG. 12) protruding from a proximal end of the distal or primary tube section 152. In some implementations, the slot 166 is further configured to receive a tab 170 (marked in FIG. 12) protruding from a distal end of the intermediate or secondary tube section 162.

[0375] In some implementations, the slot 166 and configuration of the tabs 167, 170 may aid during assembly to provide a desired rotational alignment between the intermediate or secondary connector insert 160 and the primary and secondary tube sections 152, 162. Further, the lengths of the tabs 167, 170 may be different from each other, and different from the tab 158, such that a single direction of assembly may result during manufacture and assembly of the rail shaft 120. Further, referring to FIG. 15, the secondary connector insert 160 may include opposed counter bores or annular’ recesses 172, 174 for providing concentric alignment between the secondary connector insert 160 and the respective primary tube section 152 and the secondary tube section 162.

[0376] In some implementations, a length of a section 173 in which there are no flex cuts positioned between a proximal end of the part of the primary tube section 152 having the cuts 154 and the distal end of the part of the secondary tube section 162 having the cuts 164, is a specific length to control the length of the bending arm between the distal or primary bend portion 60 and the intermediate or secondary bend portion 62 once activated, which may be optimized for target anatomy. The length can vary as required by design.

[0377] Referring to FIG. 12, the proximal or height bend portion 64 is positioned proximal of the intermediate or secondary bend portion 62 of the rail shaft 120. In some implementations, the proximal or height bend portion 64 includes a proximal or height connector insert 176 and a proximal or height tube section 168 positioned proximal of the height connector insert 176. In some implementations, the proximal or height tube section 168 has a plurality of cuts 178 for allowing bending in a third direction.

[0378] In some implementations, the third direction is opposed to the first direction that the distal or primary bend portion 60 bends towards. The third direction may be an opposite directionto the first direction and may be in the same plane of movement as the distal or primary bend portion 60. The third direction may be directly opposite the first direction, or may be at an offset angle yet opposed to the first direction in some implementations. The third direction may be transverse or perpendicular to the second direction that the intermediate or secondary bend portion 62 deflects or bends towards.

[0379] In some implementations, the plurality of cuts 178 of the proximal or height tube section 168 are circumferentially opposed to the plurality of cuts 154 of the distal or primary tube section 152.

[0380] In some implementations, a length of a section 175 in which there are no flex cuts positioned between a proximal end of the part of the secondary tube section 162 having the cuts 164 and the distal end of the part of the height tube section 168 having the cuts 178, is a specific length to control the length of the bending arm between the intermediate or secondary bend portion 62 and the proximal or height bend portion 64 once activated, which may be optimized for target anatomy. The length can vary as required by design.

[0381] FIG. 14 illustrates a perspective view of the proximal or height connector insert 176 with the proximal or height tube section 168 excluded from view. In some implementations, the proximal or height connector insert 176 includes a flattened recess or slot 180 that is configured similarly as the flattened recess or slot 166 of the secondary connector insert 160. In some implementations, tabs 182, 184 (marked in FIG. 13) of the respective tube sections 162, 168 may have different lengths and may be received by the flattened recess or slot 180 in a similar manner as the flattened recess or slot 166 of the secondary connector insert 160. In some implementations, the proximal or height connector insert 176 may include opposed counter bores or annular recesses 186, 188 that may operate in a similar manner as the opposed annular recesses 172, 174 of the secondary connector insert 160.

[0382] Referring to FIG. 14, the respective bend portions 60, 62, 64 may be bent or deflected via operation of respective pull tethers 190, 192, 194. FIG. 14, for example, illustrates a distal or primary pull tether 190 extending to the distal connector insert 150. In some implementations, the distal end portion 196 of the distal or primary pull tether 190 couples to the distal connector insert 150.

[0383] In some implementations, the distal or primary pull tether 190 may extend proximally through a channel in the secondary connector insert 160 and a channel in the proximal or height connector insert 176, and may extend through the rail proximal shaft 122 (marked in FIG. 12) to reach an adaptor within the handle 14. A proximal end portion 198 of the distal or primary pull tether 190 is marked in FIG. 16.

[0384] FIG. 14, for example, illustrates the intermediate or secondary pull tether 192 extending to the secondary connector insert 160. The distal end portion 200 of the intermediate or secondary pull tether 192 couples to the secondary connector insert 160.

[0385] In some implementations, the intermediate or secondary pull tether 192 can extend proximally through a channel in the proximal or height connector insert 176, and can extend through the rail proximal shaft 122 (marked in FIG. 12) to reach an adaptor within the handle 14. A proximal end portion 202 of the intermediate or secondary pull tether 192 is marked in FIG. 16.

[0386] FIG. 14, for example, illustrates the proximal or height pull tether 194 extending to the proximal or height connector insert 176. The distal end portion 204 of the proximal or height pull tether 194 couples to the proximal or height connector insert 176.

[0387] In some implementations, the proximal or height pull tether 194 may extend proximally through the rail proximal shaft 122 (marked in FIG. 12) to be positioned within the handle 14. A proximal end portion 206 of the proximal or height pull tether 194 is marked in FIG. 16.

[0388] In some implementations, the intermediate or secondary pull tether 192 may couple to the secondary connector insert 160 at a position that is rotationally or circumferentially offset from the position that the distal or primary pull tether 190 couples to the distal connector insert 150. The intermediate or secondary pull tether 192, for example, may couple to the secondary connector insert 160 at a position that is 90 degrees offset from the position that the distal or primary pull tether 190 couples to the distal connector insert 150. Such a configuration may allow for deflection of the intermediate or secondary bend portion 62 transverse to the direction of deflection of the distal or primary bend portion 60. Other angles may be utilized in some implementations.

[0389] Further, the proximal or height pull tether 194 may couple to the proximal or height connector insert 176 at a position that is rotationally or circumferentially offset from the position that the primary pull tether 190 couples to the distal connector insert 150 and the position that thesecondary pull tether 192 couples to the secondary connector insert 160. The proximal or height pull tether 194 may couple to the proximal or height connector insert 176 at a position 180 degrees offset from the position that the distal or primary pull tether 190 couples to the distal connector insert 150, and 90 degrees from the position that secondary pull tether 192 couples to the secondary connector insert 160. Such a configuration may allow for deflection of the proximal or height bend portion 64 in the direction opposed to the direction of deflection of the distal or primary bend portion 60.

[0390] In some implementations, other circumferential or rotational positions of coupling for the respective pull tethers 190, 192, 194 may be utilized.

[0391] Each pull tether 190, 192, 194 may be retracted by mechanisms disclosed herein to effect bending of the respective bend portion 60, 62, 64.

[0392] In some implementations, compression bodies 210, 212 may be utilized to reduce the effect of retraction of a pull tether 190 upon another of the respective bend portions 62, 64. For example, a compression body 210 may be positioned around the pull tether 190 between the secondary connector insert 160 and the height connector insert 176 for example. In some implementations, the compression body 210 may resist a compressive force applied to it during retraction of the pull tether 190, thus resisting deflection of the intermediate or secondary bend portion 62. A similar compression body 212 may be positioned on the pull tether 190 at the proximal or height bend portion 64.

[0393] In some implementations, a compression body 214 may be positioned on the intermediate or secondary pull tether 192 at the proximal or height bend portion 64. The compression body 214 may provide a similar function as the respective compression bodies 210, 212, yet for the proximal or height bend portion 64.

[0394] In some implementations, the proximal end portions of the compression bodies 212, 214 may contact tubes or hypotubes 216, 218 that may extend proximally to the handle 14. A tube or hypotube 220 may similarly extend around the proximal or height pull tether 194 and may extend proximally to the handle 14. The tethers 190, 192, 194 pass through respective hypotubes 216, 218, 220 to maintain the path of the tethers through the proximal shaft 122 and up to an adapter in the handle 14.

[0395] In some implementations, the compression bodies 210, 212, 214 may comprise compression coils or may have another form as desired.

[0396] In some implementations, the pull tethers 190, 192, 194 may comprise a single pull tether or may comprise multiple pull tethers. For example, FIG. 14 illustrates pairs of pull tethers providing the functions of the pull tethers. The pull tethers 190, 192, 194 may comprise pull wires or may have another form in some implementations. The pull tethers 190, 192, 194 may be welded to the respective connector inserts 150, 160, 176. The welding may comprise a through-weld through the respective flattened slot 156, 166, 180 of the connector insert 150, 160, 176.

[0397] Referring to FIG. 12, the rail shaft 120 may be configured such that the other assemblies (the outer sheath assembly 22, intermediate shaft or mid shaft assembly 21, inner shaft assembly 18, and nose body assembly 31) can slide distally and proximally relative to the rail shaft 120. In some implementations, the rail shaft 120, for example, may form one or more bends at the bend portions 60, 62, 64, and the other assemblies may slide longitudinally, proximally or distally, relative to the bends such that the other assemblies bend along with the shape of the rail shaft 120.

[0398] In some implementations, the other assemblies may slide longitudinally relative to the rail shaft 120 to vary a depth of the distal end portion of the elongate shaft or shaft assembly 12 relative to the rail shaft 120. In some implementations, the rail shaft 120 may be coupled to a different housing of the handle 14 than the other assemblies to produce such movement, as disclosed herein. Further, such movement between the housings may actuate a height at the proximal or height bend portion 64 as disclosed herein.

[0399] FIG. 17 illustrates a cross-sectional view of the assemblies positioned about the device retention area 16. The assemblies (the outer sheath assembly 22, intermediate shaft or mid shaft assembly 21, inner shaft assembly 18, and nose body assembly 31) may slide together distally and proximally relative to the rail shaft 120 to vary a depth of the device retention area 16 relative to the rail shaft 120, yet while retaining the device in a compressed configuration within the device retention area 16.

[0400] A side view of the example handle 14 is illustrated in FIG. 18. In some implementations, the handle 14 includes two housings 230, 232 that are adapted to slide relative to each other to adjust or actuate the depth of the distal end portion 13 of the elongate shaft assembly 12. In some implementations, the housings 230, 232 may further be adapted to sliderelative to each other to adjust or actuate a height of the distal end portion 13 of the elongate shaft assembly 12 as disclosed herein. Various controls (c.g., knobs, buttons, switches, sliders, etc.) can be used on the handle or otherwise in the system to control actuation of the height / depth and are not limited to the examples illustrated (e.g., various controls can be actuated to adjust the height / depth of a distal portion and / or distal end of the system or shaft assembly). In some implementations, the housings may be referred to as a first housing or rail housing 230 and a second housing or delivery housing 232.

[0401] FIG. 20, for example, illustrates the rail housing 230 comprising a shell that extends over a central portion 234 of the delivery housing 232. The delivery housing 232 passes through an interior cavity of the rail housing 230 with a distal end portion 236 protruding distally from the rail housing 230 and a proximal end portion 238 protruding proximally from the rail housing 230. The delivery housing 232 may slide within the interior cavity of the rail housing 230.

[0402] FIG. 19 illustrates a cross-sectional view of the distal end portion 236 of the delivery housing 232. In some implementations, the proximal end portion 240 of the outer proximal shaft 34 couples to an actuator assembly 242 for the outer sheath assembly 22. In some implementations, the actuator assembly 242, for example, may comprise a rotatable knob 244 or other form of actuator or control, and / or an adaptor 246 for sliding longitudinally within a channel of the distal end portion 236 of the delivery housing 232. In some implementations, the rotatable knob 244, for example, may rotate threading 248 that engages the adaptor 246 and causes longitudinal movement of the adaptor 246. In some implementations, the adaptor 246 accordingly may advance or retract the outer sheath 32 to advance or retract the capsule 38 (marked in FIG. 2) as desired.

[0403] In some implementations, the adaptor 246 may include a distal seal 247 and a proximal seal 249. The distal seal 247 may be for sealing against the outer proximal shaft 34. The proximal seal 249 may be for sealing against the intermediate sheath or shaft 40. The seals 247, 249 may comprise o-rings or may have another configuration in some implementations. The seals 247, 249 may be retained in position via an inner clip 251 that is positioned upon the outer proximal shaft 34, and an outer clip 253 extending over the seals 247, 249. The outer clip 253 may include the threading of the adaptor 246 for engaging the threading 248. A threaded cap 265 may be positioned at a proximal end of the adaptor 246 for securing the sealed configuration of the seals 247, 249.- M -

[0404] In some implementations, the proximal end portion 250 of the intermediate shaft 40 couples to an actuator assembly 252 for the intermediate shaft or mid shaft assembly 21. The actuator assembly 252, for example, can comprise a rotatable knob 254 or other form of actuator / control, and / or an adaptor 256 for sliding longitudinally within a channel of the distal end portion 236 of the delivery housing 232. In some implementations, the rotatable knob 254, for example, may rotate threading 258 that engages the adaptor 256 and causes longitudinal movement of the adaptor 256. The adaptor 256 accordingly may advance or retract the intermediate shaft 40 to advance or retract the outer retention member or ring 46 (marked in FIG. 3) as desired.

[0405] In some implementations, the adaptor 256 may include a distal seal 255 and a proximal seal 257. The distal seal 255 may be for sealing against the intermediate sheath or shaft 40. The proximal seal 257 may be for sealing against the rail shaft 120. The seals 255, 257 may comprise o-rings or may have another configuration in some implementations. The seals 255, 257 may be retained in position via an inner clip 267 that is positioned upon the intermediate sheath or shaft 40, and an outer clip 269 extending over the seals 255, 257. The outer clip 269 may include the threading of the adaptor 256 for engaging the threading 258 of the actuator assembly 252. A threaded cap 275 may be positioned at a proximal end of the adaptor 256 for securing the sealed configuration of the seals 255, 257.

[0406] As shown in FIG. 19, the outer sheath assembly 22 and the intermediate shaft or mid shaft assembly 21 are each coupled to the delivery housing 232, and accordingly are slidable together relative to the rail shaft 120 and the rail housing 230.

[0407] FIG. 20 illustrates a cross-sectional view of the rail housing 230. In some implementations, the rail housing 230 includes an adaptor 260 that couples to the proximal end portion 262 of the rail shaft 120. The adaptor 260 may include a distal seal 259 that seals against the rail shaft 120. In some implementations, the adaptor 260 may include a proximal seal 261 that seals against the inner shaft 130 and the pull tethers 190, 192, 194. In some implementations, the adaptor 260 may include a flush valve 263 utilized to flush the delivery system. In some implementations, the rail housing 230 may include actuator assemblies 264, 266 for actuation of the respective distal or primary pull tether 190 and the intermediate or secondary pull tether 192.

[0408] The distal or primary actuator assembly 264 for example may include a rotatable knob 268 or other form of actuator / control, and / or an adaptor 270. In some implementations, therotatable knob 268 may be configured to rotate about threading positioned on the rail housing 230 (c.g., on an outer surface of the rail housing 230) to produce longitudinal movement of the rotatable knob 268. In some implementations, the longitudinal movement of the rotatable knob 268 may accordingly result in a longitudinal movement of the adaptor 270 to produce a corresponding movement of the distal or primary pull tether 190.

[0409] In some implementations, the intermediate or secondary actuator assembly 266 may operate in a similar manner as the distal or primary actuator assembly 264 and may include a rotatable knob 272 or other form of actuator / control, and / or an adaptor 274. In some implementations, the actuator assemblies 264, 266 may actuate the respective distal or primary bend portion 60 and the intermediate or secondary bend portion 62.

[0410] FIG. 21 illustrates a perspective view of the adaptors 270, 274 isolated from the rail housing 230 and from the rotatable knobs 268, 272. In some implementations, the adaptors 270, 274 are shown coupled to the respective proximal end portions of the distal or primary pull tether 190 and the intermediate or secondary pull tether 192.

[0411] FIG. 22 illustrates a perspective view of the adaptor 270 with a plate housing 280 shown in transparency. In some implementations, the adaptor 270 includes an opening 282 for receiving the distal or primary pull tether 190. In some implementations, the adaptor 270 may further include an opening 284 of a channel for the intermediate or secondary pull tether 192 to pass through to engage with the adaptor 274. In some implementations, the adaptor 270 may further include an opening 286 of a channel for the proximal or height pull tether 194 to pass through to engage with a coupler 302 (marked in FIG. 21) on the delivery housing 232.

[0412] In some implementations, the adaptor 270 comprises the plate housing 280, with a plate 290 (shown in FIG. 24) positioned within the plate housing 280. Referring to FIG. 24, the plate 290 includes a coupler 294 for coupling with the distal or primary pull tether 190, and includes an opening 295 for the proximal or height pull tether 194 to pass through.

[0413] FIG. 23 illustrates a perspective view of the adaptor 274 including a plate housing 296 configured similarly as the plate housing 280. The plate 290 is inverted in position than in the configuration shown in FIG. 22. As such, the plate 290 is positioned to provide a coupler 298 for the intermediate or secondary pull tether 192. In some implementations, the plate housing 296 isfurther adapted to include an opening 300 of a channel for the proximal or height pull tether 194 to pass through to engage with a coupler 302 on the delivery housing 232.

[0414] In some implementations, the position of the opening 300 corresponds to the opening 295 of the plate 290 shown in FIG. 24. The pull tether 194 passing through to engage the coupler 302 is represented in FIG. 21. Snap assembly of the plate and plate housing may be utilized.

[0415] In some implementations, the proximal end portions of the respective pull tethers 190, 192, 194 (as marked in FIG. 16) may include respective stoppers, plugs, or couplers 304, 306, 308. In some implementations, the couplers 304, 306 may be crimped or welded on the ends of the pull tethers 190, 192 and adapted to engage the adaptors 270, 274. In some implementations, the coupler 308 may be crimped or welded on the end of the pull tether 194 and adapted to engage the coupler 302. Other methods of attachment may be utilized in some implementations.

[0416] In some implementations, the proximal end portion of the respective pull tethers 190, 192, 194 (as marked in FIG. 16) may include a respective shrink material 303, 305, 307 for covering a portion of the pull tether 190, 192, 194. The shrink material 303, 305, 307 may comprise a heat shrink material in some implementations. The material 303, 305, 307 may be utilized to produce a hemostasis seal with the rail adaptor 260 in some implementations.

[0417] FIG. 25 illustrates a perspective cross-sectional view of the proximal end portion 238 of the delivery housing 232. The delivery housing 232 may include a coupler 310 for engaging the proximal end portion of the inner shaft 130. The inner shaft 130 accordingly may be retained in position relative to the delivery housing 232 and may move with the movement of the delivery housing 232. The coupler 310, for example, may comprise a threaded coupler for threaded engagement with the inner shaft 130. Other forms of coupling may be utilized in some implementations.

[0418] In some implementations, the proximal end portion of the nose body shaft 140 may couple to an actuator assembly 320 including a rotatable knob 322 or other form of actuator / control, and / or an adaptor 324. In some implementations, an outer surface of the adaptor 324 may be threaded and may engage with a threading on an interior surface of the rotatable knob 322. In some implementations, rotation of the knob 322 (or actuation of another actuator / control) may longitudinally drive the adaptor 324 proximally or distally as desired and accordingly proximally or distally slide the nose body shaft 140 and the nose body 142 (marked in FIG. 6).

[0419] In some implementations, the adaptor 324 may comprise an elongate body adapted to slide within an interior cavity 326 of the proximal end portion 238 of the delivery housing 232.

[0420] In some implementations, the inner shaft assembly 18 and the nose body assembly 31 are each adapted to slide with the movement of the delivery housing 232 relative to the rail housing 230.

[0421] In some implementations, the delivery housing 232 is adapted to engage the proximal end portion 206 of the proximal or height pull tether 194. In some implementations, the coupler 302 shown in FIG. 21, for example, may comprise a plate that may be positioned within the delivery housing 232 at the proximal end portion 238 of the delivery housing 232. In some implementations, the coupler 302 may be positioned proximate the coupler 310 for the inner shaft 130. In some implementations, the coupler 302 may include an opening sized to receive the proximal end portion 206 of the proximal or height pull tether 194.

[0422] In some implementations, the proximal end portion 238 of the delivery housing 232 may include a channel 328 that may extend longitudinally and may be configured for the proximal end portion 206 of the proximal or height pull tether 194 to slide within. As such, the proximal end portion 206 of the proximal or height pull tether 194 may slide relative to the delivery housing 232. FIG. 32, for example, illustrates a cross-sectional view showing the channel 328.

[0423] In some implementations, the proximal end portion 206 of the proximal or height pull tether 194 including the stopper, plug, or coupler 308 may slide within the channel 328 yet may be impeded from sliding distally past the coupler 302 due to the increased size of the stopper, plug, or coupler 308. In some implementations, the coupler 302 and plug or coupler 308 may form a catch assembly for engaging the proximal end portion 206 of the proximal or height pull tether 194. In some implementations, the plug or coupler 308 may be impeded from passing through the opening in the coupler 302. In some implementations, the plug or coupler 308 may slide proximally within the channel 328 yet not distally further than the coupler 302.

[0424] Referring to FIG. 26, in some implementations, the handle 14 may include a brace 330 that may be positioned within an interior cavity 332 of the rail housing 230. The brace 330 may further be positioned within an interior cavity 334 of the delivery housing 232. In some implementations, the brace 330 may be coupled to the rail housing 230 and configured to move with the movement of the rail housing 230.

[0425] In some implementations, the brace 330 may be configured to resist an inward force or compression of the delivery housing 232 and the rail housing 230. Such inward force or compression may result from the tension being applied to the proximal or height pull tether 194 by the delivery housing 232. In some implementations, other positions of the brace 330 may be utilized.

[0426] Referring to FIG. 27, the handle 14 may include an actuator assembly 340 or other actuator / control for sliding the delivery housing 232 relative to the rail housing 230. The actuator assembly 340, for example, may comprise a rotatable knob 342 or other actuator / control configured to engage threading on the delivery housing 232. The rotatable knob 342 may have a fixed rotational coupling with the rail housing 230. Rotation of the rotatable knob 342 accordingly may drive the delivery housing 232 proximally or distally relative to the rail housing 230.

[0427] In some implementations, the proximal or height pull tether 194 can engage with the delivery housing 232 at a position that is proximal of the actuator assembly 340 and distal of the nose body actuator assembly 320. In some implementations, the proximal or height pull tether 194 may engage via the engagement of the coupler 302 and the stopper, plug, or coupler 308.

[0428] In some implementations, the coupling of the outer sheath assembly 22, the intermediate shaft or mid shaft assembly 21, the inner shaft assembly 18, and the nose body assembly 31 to the delivery housing 232 accordingly can cause such assemblies to slide together distally and proximally relative to the rail shaft 120 (which is coupled to the rail housing 230). In some implementations, such movement may vary a height / depth (e.g., a position relative to a base of the heart and a top of the heart, a position relative to an atrium and ventricle of a heart, a position relative to a heart valve or portion thereof, a position relative to an apex of the heart, a position relative to a component of the system, a position relative to an axis of the shaft (such as the length of shaft just prior to the steerable region), etc.) of the distal end portion of the elongate shaft assembly and device retention area 16 relative to the rail shaft 120, yet while retaining the device in a compressed configuration within the device retention area 16.

[0429] In some implementations, the height / depth may be provided due to distal movement of the delivery housing 232 and the coupled outer sheath assembly 22, intermediate shaft or mid shaft assembly 21, inner shaft assembly 18, and the nose body assembly 31 relative to the rail shaft 120(and the rail housing 230). Features of producing depth disclosed in International Application No.PCT / US2020 / 054786 may be utilized herein.

[0430] In some implementations, the delivery housing 232 is adapted to slide in a proximal direction relative to the rail housing 230 to retract the proximal or height pull tether 194 to bend the proximal or height bend portion 64 to produce height (e.g., move a position toward a top of a heart, move in an atrial direction, move relative to an axis of the region of the shaft just prior to the bent region, etc.). In some implementations, such retraction occurs due to the engagement between the proximal or height pull tether 194 and the delivery housing 232 at the coupler 302 (as represented in FIG. 32).

[0431] FIGS. 28-35 illustrate an exemplary operation of the delivery system 10 to produce height and depth (e.g., change the position relative to another component, change the position relative to an axis of the shaft prior to the bending region, change the position relative to one or more portions of the heart, a position more atrial or more ventricular, a position away from or toward an apex of the heart, etc.). FIG. 28, for example, illustrates the distal end portion 13 of the elongate shaft assembly 12, with the elongate shaft assembly 12 including respective bend portions 350, 352, 354 corresponding to the positions of the respective primary bend portion 60, secondary bend portion 62, and height bend portion 64 of the interior rail shaft 120. The elongate shaft assembly 12 is shown in a straightened or linear configuration in FIG. 28.

[0432] In some implementations, the bend portion 350 has bent to extend downward in a first direction in FIG. 29. FIG. 29 illustrates a side view of the elongate shaft 12. FIG. 30 illustrates a top view of the elongate shaft 12. The bend portion 352 has bent transverse to the direction of the bend portion 350. FIG. 31 illustrates a side view of the delivery system 10 in such a configuration. The height of the elongate shaft 12 has not yet been adjusted or actuated (e.g., controls have not yet been actuated to adjust the height, e.g., adjust the position). FIG. 32 illustrates a side cross- sectional view of the delivery housing 232 in such a configuration, with the plug or coupler 308 of the proximal or height pull tether 194 positioned adjacent to the plate coupler 302 of the delivery housing 232. In some implementations, the proximal or height pull tether 194 may lack tension at such a point or may have a slight tension applied by the plate coupler 302 of the delivery housing 232.

[0433] FIG. 33 illustrates the actuator assembly 340 having been actuated to produce a depth of the distal end portion 13 of the elongate shaft 12. In some implementations, the delivery housing 232 advances relative to the rail housing 230 to slide the outer sheath assembly 22, the intermediate shaft or mid shaft assembly 21, the inner shaft assembly 18, and the nose body assembly 31 together distally relative to the rail shaft 120 (which is coupled to the rail housing 230) to produce depth.

[0434] FIG. 34 illustrates a side cross-sectional view of the delivery housing 232 in such a configuration, with the coupler 308 of the proximal or height pull tether 194 slid proximally within the channel 328. As such, the coupler 308 slides proximally from the plate coupler 302 of the delivery housing 232 and lacks a tension applied by the plate coupler 302.

[0435] At a desired time, the actuator assembly 340 may be actuated in a reverse direction to retract the delivery housing 232 relative to the rail housing 230. In some implementations, the outer sheath assembly 22, the intermediate shaft or mid shaft assembly 21, the inner shaft assembly 18, and the nose body assembly 31 together move proximally relative to the rail shaft 120 (which is coupled to the rail housing 230) to reduce depth (e.g., to move atrially, move the distal tip toward an axis of the shaft, move away from an apex of a heart, etc.). Further, a transition occurs to cause the coupler 308 of the proximal or height pull tether 194 to engage with and press against the plate coupler 302 of the delivery housing 232 and cause tension to be produced in the proximal or height pull tether 194. A resulting position of the engagement of the couplers 308, 302 is represented in FIG. 32.

[0436] In some implementations, the tension applied to the proximal or height pull tether 194 deflects the proximal or height bend portion 64 of the rail shaft 120 and produces a height deflection in the elongate shaft assembly 12 as represented in FIG. 35 (e.g., aposition of the distal end of the elongate shaft assembly 12 is moved closer to an axis extending down the middle of the region of the shaft prior to the bent region, in a heart this could move the distal end in an atrial direction or away from an apex of the heart).

[0437] Referring to FIG. 27, the transition between the depth (represented in FIG. 33) of the elongate shaft assembly 12 and the height (represented in FIG. 35) of the elongate shaft assembly 12 may be provided by one or more indicators. In some implementations, the indicators may be visual, haptic, or audible in some implementations.

[0438] An example visual indicator 360 is illustrated in FIG. 27. The visual indicator 360 may comprise markings on handle 14 that indicate the position of the rail housing 230 relative to the delivery housing 232. A “zero point” or position of neither depth nor height is represented in FIG. 27. Upon distal movement of the delivery housing 232 relative to the rail housing 230, the indicator will indicate the amount of depth produced. The overlap of a side of the rotatable knob 342 relative to the visual indicator 360 provides the measure of the depth. Numerical indicators or other forms of graduations (e.g., hash marks, patterns, symbols) may be provided on the delivery housing 232. A reverse movement of the delivery housing 232 may produce an indication of height. Similar or different forms of visual indicators may be utilized to indicate height. In FIG. 27, different colors may be utilized with a key of “D” for depth and “H” for height may be utilized to indicate the difference and the transition point between depth and height.

[0439] In some implementations, other forms of indicators may be utilized solely or in combination. FIG. 36, for example, illustrates a haptic indicator 370 that may be utilized to indicate the transition between depth and height. The rail housing, for example, may interfere with the delivery housing at the transition point to produce a vibration or other form of transition. In FIG. 36, a brace 372 that may be utilized in the position of the brace 330 may be utilized and may include protrusions in the form of sequential ridges 374 for interfering with protrusions 376 (marked in FIG. 37) on the delivery housing 378 (which may otherwise be configured similarly as the delivery housing 232). The movement of the delivery housing 378 relative to the brace 372 at the transition point may produce a haptic vibration or rumble for an individual holding the handle. Other positions of the haptic indicator may be utilized in some implementations.

[0440] FIGS . 38-40 illustrate a configuration of an audible indicator that may be utilized. FIG. 38 illustrates a perspective view of the rail housing 230 with a rotatable knob excluded from view. A tab 380 is positioned on the rail housing 230 in position to be contacted by the delivery housing 232 upon longitudinal movement of the delivery housing 232 relative to the rail housing 230 at the transition point between depth and height.

[0441] FIG. 39 illustrates an opposite side view of the rail housing 230. An additional tab 382 may be provided, to be contacted by the delivery housing 232 upon longitudinal movement of the delivery housing 232 relative to the rail housing 230 at the transition point between depth and height. The tabs 380, 382 may be positioned to bound protrusions 384 of the delivery housing 232at the “zero point” between depth and height. Representative protrusions 384 on the delivery housing 232 arc illustrated in FIG. 40. Upon a movement towards “depth,” the tab 382 may click past a protrusion 384 of the delivery housing 232 and make an audible sound. Similarly, upon a movement towards “height,” the tab 380 may click past a protrusion 384 of the delivery housing 232 and make an audible sound. The positions of the tabs 380, 382 or protrusions 384 may be set to make an audible sound at a desired point.

[0442] In some implementations, the haptic and audible indicators may beneficially provide an indication to a user of a transition between height and depth in a low visibility environment (e.g., low light levels) in which visible indicators may be difficult to discern, or may be utilized to supplement other forms of indicators that may be utilized.

[0443] FIGS. 41-44 illustrate an example deployment of a treatment device utilizing the delivery system 10. Referring to FIG. 41, transcutaneous entry of the patient’s vasculature may occur. Methods of entry disclosed in International Application No. PCT / US2020 / 054786 may be utilized herein.

[0444] The elongate shaft assembly 12 may be navigated through the vasculature to a desired position of device. For example, referring to FIG. 41, delivery to a tricuspid heart valve 400 may be desired. The elongate shaft assembly 12 may be navigated to enter the right atrium 402 of the heart. In configurations in which deployment is to the mitral valve 404, a transseptal puncture may occur with the elongate shaft assembly 12 entering the left atrium 406 of the heart.

[0445] Referring to FIG. 42, the distal end portion 13 of the elongate shaft assembly 12 may enter the right atrium 402 via the inferior vena cava 408. In some implementations, other entry points (e.g., the superior vena cava) may be utilized as desired. The elongate shaft assembly 12 may be deflected within the right atrium 402 via use of one or more of the bend portions 60, 62, 64 to angle the elongate shaft assembly 12 as desired relative to the tricuspid valve 400.

[0446] In some implementations, the height provided by use of the proximal or height bend portion 64 may be utilized to allow the elongate shaft 12 to produce the bend to become axial or face axially towards the tricuspid valve 400. For example, the geometry within the right atrium 402 may require that height be produced in a direction away from the tricuspid valve 400 to allow for the bend of the elongate shaft 12 towards the tricuspid valve 400 (e.g., with the primary bendportion 60). Other bends of the shaft (e.g., primary or secondary bends) may be utilized to center and align the elongate shaft 12 as desired with respect to the tricuspid valve 400.

[0447] In some implementations, the height may be utilized to position the capsule 38 at a greater height within the annulus of the tricuspid valve 400. For example, the capsule 38 may be positioned low, or towards the right ventricle 410, at an undesirable height. The deployment of the device accordingly may be low or towards the ventricular’ side of the annulus of the tricuspid valve 400. In an example in which the device includes anchors adapted to engage leaflets of the tricuspid valve 400, such low or ventricular positioning may impede the ability of the device to properly anchor and engage with the tricuspid valve 400.

[0448] A low placement of a device may produce interference with a lower heart wall, or may produce a risk of chordal engagement, ventricular perforation, or difficulty with anchoring. As such, height may be utilized to position and seat the device higher or more atrial for proper deployment. Other combinations of uses of the height feature may be utilized in some implementations .

[0449] With the capsule 38 in a desired position, the capsule 38 may be retracted to produce expansion of the device 420. FIG. 43, for example, illustrates a retraction of the capsule 38 to produce expansion of the device 420. The device 420 may expand and may include anchors 422 for engaging leaflets of the valve 400. In a configuration as shown in FIG. 43, the height feature has been removed, yet the height feature may remain in use during retraction of the capsule 38 as desired. In some implementations, the depth feature may be utilized as desired to position the capsule 38 in the desired axial position relative to the tricuspid valve 400.

[0450] A multi-stage deployment may occur, with the capsule 38 retracted initially, and then the outer retention member or ring 46 retracted subsequently. The outer retention member or ring 46 may retract to fully release the device 420 into position as represented in FIG. 44. Features of a multi-stage deployment disclosed in International Application No. PCT / US2020 / 054786 may be utilized herein.

[0451] With the device 420 in position, the nose body 142 may be retracted proximally through the interior of the device 420 (the interior flow channel of the device 420). The elongate shaft assembly 12 may then be retracted and removed in a reverse operation from the entry into the right atrium.

[0452] In some implementations, a similar procedure may be utilized for deployment to the native mitral valve, yet with access provided to the left atrium and / or left ventricle. In some implementations, other entries or approaches may be utilized including transapical or approaches with open heart surgery. Treatment devices (e.g., implants, prosthetic heart valves, repair devices, etc.) as disclosed herein or other forms of treatment devices may be utilized as desired.

[0453] Treatment devices and methods of deployment disclosed in International Application No. PCT / US2020 / 054786, which is incorporated by reference herein in its entirety for all purposes, can be utilized herein (e.g., can be utilized with the concepts, systems, devices, methods, etc. herein).

[0454] Variations in the configuration of the delivery system 10 may be provided in some implementations. FIG. 45, for example, illustrates an implementation in a configuration of at least a portion of the elongate shaft assembly 12, which may comprise an implementation in the configuration of the rail shaft assembly.

[0455] Referring to FIG. 45, at least one of a distal or primary pull tether 450, or an intermediate or secondary pull tether 452, or a proximal or height pull tether 454 spirals within an interior lumen 456 to be positioned circumferentially closer to one other of the primar y pull tether 450, the secondary pull tether 452, or the height pull tether 454. The respective pull tethers may otherwise be configured similarly as the respective pull tethers 190, 192, 194. For example, the distal or primary pull tether 450 may be adapted to bend the distal or primary bend portion 458, the intermediate or secondary pull tether 452 may be adapted to bend the intermediate or secondary bend portion 460, and the proximal or height pull tether 454 may be adapted to bend the proximal or height bend portion 462.

[0456] The bend portions 458, 460, 462 may be configured similarly as the respective bend portions 60, 62, 64 and may operate in a similar manner. The bend portions 458, 460, 462 may include inserts and connections to the pull tethers in a similar- manner as the bend portions 60, 62, 64. The bend portion 460 may be positioned proximal of the bend portion 458, and the bend portion 462 may be positioned proximal of the bend portion 460. The bend portions 458, 460, 462 may each include cuts to provide a direction of bending of the respective bend portion. For example, the bend portion 462 may have a plurality of cuts that are circumferentially opposed tothe cuts of the bend portion 458 to allow for bending in a direction that is opposed to the direction of the distal or primary bend portion 458.

[0457] The pull tethers 450, 452, 454 may spiral in a variety of manners. In a configuration as shown in FIG. 45, the intermediate or secondary pull tether 452 may remain linear (nonspiraling) through the intermediate or secondary bend portion 460 and through the proximal or height bend portion 462. The primary pull tether 450, however, may spiral within the intermediate or secondary bend portion 460 and / or the proximal or height bend portion 462 to be positioned circumferentially adjacent to the intermediate or secondary pull tether 452 within the proximal or height bend portion 462. Notably, the primary pull tether 450 may be covered with a compression body or compression coil at the intermediate or secondary bend portion 460 and / or the proximal or height bend portion 462 such that the effects of the spiraling are nullified or reduced in such portions.

[0458] In a configuration as shown in FIG. 45, the proximal or height pull tether 454 spirals within the proximal or height bend portion 462 to be positioned circumferentially adjacent to the intermediate or secondary pull tether 452 within the proximal or height bend portion 462.

[0459] FIG. 46A illustrates a cross-sectional view at line A-A illustrating the position of the primary pull tether 450. FIG. 46B illustrates a cross-sectional view at line B-B illustrating the primary pull tether 450 spiraling towards the intermediate or secondary pull tether 452. FIG. 46C illustrates a cross-sectional view at line C-C illustrating the primary pull tether 450 being circumferentially adjacent to the intermediate or secondary pull tether 452, and the proximal or height pull tether 454 spiraling circumferentially towards the intermediate or secondary pull tether 452. FIG. 46D illustrates a cross-sectional view at line D-D illustrating the close circumferential positioning of the pull tethers 450, 452, 454.

[0460] Other configurations of spiraling may be utilized. For example, the proximal or height pull tether 454 may remain linear within the proximal or height bend portion 462 and the primary pull tether 450 may spiral within the intermediate or secondary bend portion 460 and / or the proximal or height bend portion 462 to be positioned circumferentially adjacent to the proximal or height pull tether 454. The intermediate or secondary pull tether 452 may spiral within the proximal or height bend portion 462 to be positioned circumferentially adjacent to the proximal or height pull tether 454. The portions of the pull tethers that spiral in some implementations may becovered with a compression body or compression coil such that the effects of the spiraling are nullified in such portions.

[0461] The spiraling may occur to position the pull tethers 450, 452, 454 to one side, segment, or arc of the interior lumen 456, to thus increase the size of a clearance area 470 of the interior lumen for an interior shaft to extend within. The clearance area 470 is marked in FIG. 46D in dashed lines. The clearance area 470 may be beneficially increased in size to allow for larger shafts or assemblies to pass through the interior lumen 456. The clearance area 470 may be circular for example (as marked in FIG. 46D), with the available diameter 472 of the clearance area 470 increased to accommodate larger shafts or assemblies.

[0462] In some implementations, the pull tethers 450, 452, 454 may extend within the proximal or height bend portion 462 at a smallest circumferential arc 474 of less than 110 degrees. In some implementations, the smallest circumferential arc 474 may be less than 90 degrees. In some implementations, the smallest circumferential arc 474 may be less than 80 degrees. Various other configurations may be utilized in some implementations. For example, only one of the pull tethers 450, 452, 454 may spiral, which may thus create a larger arc that the pull tethers 450, 452, 454 may be positioned within.

[0463] In some implementations, more than one pull tether may be utilized for each bend portion. FIG. 47, for example, illustrates a perspective cross-sectional representation including two pull tethers per bend portion utilized. The pull tethers may spiral together to be positioned circumferentially adjacent as shown in FIG. 47. A larger clearance area for interior shafts or lumens may result.

[0464] Features described in regal’d to FIGS. 45-47 may be utilized solely or in combination with any other example herein.

[0465] Further variations in the configuration of the delivery system 10 may be utilized in some implementations. FIGS. 48-50, for example, illustrate an implementation in which a single pull tether 480 or set of pull tethers is utilized to actuate a distal or primary bend portion 482 and a proximal or height bend portion 484. The system may include an intermediate or secondary pull tether 486 for operating an intermediate or secondary bend portion 488 in a similar manner as the intermediate or secondary pull tether 192.

[0466] The bend portions 482, 488, 484 may be configured similarly as the respective bend portions 60, 62, 64 and may operate in a similar manner. The bend portion 488 may be positioned proximal of the bend portion 482, and the bend portion 484 may be positioned proximal of the bend portion 488. The bend portions 482, 488, 484 may each include cuts to provide a direction of bending of the respective bend portion. For example, the bend portion 484 may have a plurality of cuts that are circumferentially opposed to the cuts of the bend portion 482 to allow for bending in a direction that is opposed to the direction of the distal or primary bend portion 482.

[0467] The distal or primary pull tether 480, however, may lack a compression body or compression coil at the proximal or height bend portion 484 and thus the force produced by the distal or primary pull tether 480 may be exerted against the height bend portion 484. As such, the retraction of the distal or primary pull tether 480 may simultaneously bend the distal or primary bend portion 482 and the proximal or height bend portion 484 to produce a deflection in the direction of the primary bend portion 482 and the height bend portion 484. As such, an “S” shaped deflection (as represented in FIG. 50) may result. The intermediate or secondary bend portion 488 may be actuated to produce a deflection in a transverse direction as desired.

[0468] In some implementations, the position of the height bend portion 484 and the secondary bend portion 488 may be alternated, with the height bend portion 484 positioned between the secondary bend portion 488 and the distal or primary bend portion 482.

[0469] In some implementations, the distal or primary pull tether 480 may couple to the distal or primary bend portion 482 at a first circumferential position and may pass through the height bend portion 484 at an angle that is circumferentially offset from the first circumferential position. For example, referring to FIG. 49, the first circumferential position is indicated in dashed lines in FIG. 49. The offset position within the height bend portion 484 is indicated in solid lines for reference number 480. The offset position may more easily allow the force from the distal or primary pull tether 480 to be applied to the height bend portion 484 to produce height. The angle offset may be less than 180 degrees in some implementations. The angle offset may be at about 120 degrees in some implementations (as represented in FIG. 49). Other angles may be utilized as desired. The distal or primary pull tether 480 may spiral within the height bend portion 484 to produce the offset as desired. Other configurations may be utilized in some implementations.

[0470] The distal or primary pull tether 480 may be actuated via a distal or primary actuator assembly 264 as disclosed herein.

[0471] Features described in regard to FIGS. 48-50 may be utilized solely or in combination with any other example herein.

[0472] Further variations in the configuration of the delivery system 10 may be utilized in some implementations. FIGS. 51-54, for example, illustrate an implementation in which the outer sheath assembly of the delivery system is utilized to produce a deflection or height of the elongate shaft assembly (e.g., a position relative to other components, a position relative to an axis of the shaft, a position relative to a portion of the heart, etc.).

[0473] For example, referring to FIG. 51, the delivery system includes an elongate shaft assembly 490 that may be configured similarly as the elongate shaft assembly 12 unless stated otherwise. The elongate shaft assembly 490 includes an outer sheath 492 having the capsule 494 for extending over an internal device retention area. The outer sheath 492 may extend along a longitudinal axis. The outer sheath 492 may include a plurality of cuts 496 that may be utilized to allow bending of the outer sheath 492 and any shafts or subassemblies contained within.

[0474] A pull tether 498 (marked in FIG. 52) may be provided that is adapted to apply a force to the outer sheath 492 to bend the sheath 492 in a direction transverse to the longitudinal axis. The direction may comprise a height (or bending in a direction opposite a depth of the elongate shaft assembly 490) deflection or may comprise one or more different directions of deflection in some implementations (e.g., based on the rotational orientation of the outer sheath 492). In some implementations, the outer sheath 492 may be utilized solely or in combination with a rail shaft assembly as disclosed herein.

[0475] FIGS. 51 and 52 illustrate a form of actuator assemblies that may be utilized to actuate advancement and retraction of the capsule 494 and actuate the pull tether 498. An actuator assembly 500 may be utilized that may be configured similarly as the actuator assembly 242 shown in FIG. 18. The actuator assembly 500, for example, may include a rotatable knob that may be rotated to advance or retract the capsule 494 due to an engagement between the rotatable knob and the outer sheath 492. An additional or second actuator assembly 502 may be utilized to actuate the pull tether 498. The actuator assemblies 500, 502 may be positioned on a handle or at another position as desired.

[0476] Referring to FIG. 52, the actuator assembly 502 may include a spool 504 for retaining the free portion of the pull tether 498. A pawl and ratchet mechanism may further be utilized as desired. The actuator assembly 502 may further include a rotatable knob 503. The spool 504 may retain a free length of the pull tether 498 that may be produced upon retraction of the outer sheath 492. For example, the spool 504 may rotate in a first direction to draw in or receive the free length of the pull tether 498 upon retraction of the outer sheath 492 and may rotate in a second opposite direction to deploy the pull tether 498 upon advancement of the outer sheath 492. In some implementations, a detent 506 may be provided to couple the actuator assemblies 500, 502 together such that rotation of the actuator assembly 500 produces rotation of the second actuator assembly 502 when the actuator assemblies 500, 502 are engaged together with the detent 506.

[0477] FIG. 53, for example, illustrates the rotation of the actuator assembly 500 retracting the outer sheath 492 and rotating the second actuator assembly 502. The free length of the pull tether 498 is received by the spool 504. As such, movement of the outer sheath 492 may occur without the pull tether 498 deflecting the outer sheath 492.

[0478] At a desired time, the second actuator assembly 502 may be rotated relative to the actuator assembly 500 to disengage the detent 506 and produce independent movement of the pull tether 498. FIG. 54, for example, illustrates the rotation of the second actuator assembly 502 to draw the pull tether 498 onto the spool 504 and thus producing a bend of the outer sheath 492. The bend may comprise a height or may comprise one or more different directions of deflection based on the rotational orientation of the outer sheath 492.

[0479] Features described in regard to FIGS. 51-54 may be utilized solely or in combination with any other example herein.

[0480] Further variations in the configuration of the delivery system 10 may be utilized in some implementations. FIGS. 55-56, for example, illustrate an implementation in which at least a portion of the elongate shaft assembly 510 is precurved to bend the elongate shaft assembly 510 in a direction transverse to a longitudinal extent of the elongate shaft assembly 510 (e.g., to a longitudinal axis of a section of the shaft assembly 510). In some implementations, one or more shafts or assemblies of the elongate shaft assembly 510 may be precurved as desired. The elongate shaft assembly 510 may otherwise be configured similarly as the elongate shaft assembly 12 unlessstated otherwise. For example, the elongate shaft assembly 510 may include a device retention area for retaining the device and may include other features of the elongate shaft assembly 12.

[0481] Referring to FIG. 55, in some implementations, the mid shaft or intermediate shaft 512 may have the precurvature. The mid shaft or intermediate shaft 512 may otherwise be configured similarly as the intermediate shaft 40 and may be utilized in the same position and for the same function as the intermediate shaft 40. The intermediate shaft 512 may include a proximal tube 514 that may be precurved in a direction. A distal end of the proximal tube 514 may couple to a hypotube section or flexible section 516 that may have flexibility in multiple directions. The flexible section 516 may correspond to a position of a rail shaft and to the bend portions of a rail shaft. The flexible section 516 may allow for flexibility at the bend portions of the rail shaft and for the intermediate shaft 512 to follow such bends. The proximal tube 514, however, may remain precurved and able to apply the curvature to the other shafts or assemblies of the elongate shaft assembly 510. The intermediate shaft 512 may include an outer retention member or ring 518 that may be configured similarly as the outer retention member or ring 46. The outer retention member or ring 518 may engage a device within the device retention area in a similar manner as the outer retention member or ring 46.

[0482] The intermediate shaft 512 may be utilized with other assemblies disclosed herein, including an outer sheath assembly, a rail shaft assembly, an inner shaft assembly, and a nose body assembly. The intermediate shaft 512 may be positioned between the rail shaft assembly and the outer sheath assembly as disclosed herein, or may have alternative positions in some implementations as desired. The other assemblies or shafts may lack a precurvature in some implementations .

[0483] The curvature of the intermediate shaft 512 may produce a bending of the elongate shaft assembly 510 as represented in FIG. 56. The bending may be a height, or a bending in a direction opposed to a direction of deployment of the device. In some implementations, the bending may be in a direction opposed to a direction of bending of a bend portion 520 of the elongate shaft assembly 510. The height may produce the benefits discussed in regal'd to the height feature of the delivery system 10. The height may improve navigation and deployment of a device to a desired treatment site, e.g., an implantation site, etc. For example, additional height or distancefrom the apex of the heart (e.g., a more atrial position in the valve) may allow the device to be better deployed (e.g., anchor behind leaflets and scat in the native valve at a better location, etc.)

[0484] In some implementations, usable with any of the systems and devices herein, one or more methods herein may advantageously involve releasing anchors of a device in a more ventricular position, then adjusting a height of the delivery system to move the anchors towards the valve and behind the leaflets before releasing the remainder of the valve. Releasing the anchors in a ventricular location, then moving them in an atrial direction can help ensure the leaflets are properly captures and the anchors are properly seated through any chordae and behind the leaflets.

[0485] In some implementations, the intermediate shaft 512 may be rotatable about a longitudinal axis of the elongate shaft assembly 510. Such a feature may allow the direction of the bending to be varied to a desired direction (e.g., at any direction of the 360 degrees of rotation of the intermediate shaft 512). The intermediate shaft 512 may be used in combination with or in lieu of the use of multiple bend portions of a rail shaft assembly as disclosed herein.

[0486] In some implementations, other shafts or portion of the elongate shaft assembly may be precurved to produce a desired result.

[0487] Referring to FIG. 57, in some implementations, a precurved shaft 530 may be utilized in a similar manner to deflect an elongate shaft assembly as desired. The precurved shaft 530 may be configured to be inserted into or along the elongate shaft assembly in vivo to curve the elongate shaft assembly. The elongate shaft assembly, for example, may be placed in a desired position within the patient’s vasculature. The precurved shaft 530 may then be inserted into the elongate shaft assembly to produce a height or other form of bending as desired. A configuration as shown in FIG. 56 may result. In some implementations, the precurved shaft 530 may be rotated to vary the direction of the bending as desired.

[0488] Features described in regard to FIGS. 55-57 may be utilized solely or in combination with any other example herein.

[0489] Other variations of the delivery systems disclosed herein may be utilized. For example, the order of the intermediate and height bend portions may be interchanged. As such, the terms “first bend portion,” “second bend portion,” and “third bend portion” and the corresponding pull tethers may be interchanged in use as desired. Further, in some implementations, the secondarybend portion and pull tether may be excluded such that primary and height are only utilized. The distal end portion of the elongate shaft assemblies may comprise the outer sheath assemblies or the nose body assemblies, although other assemblies may form the distal end portion of the elongate shaft assemblies in some implementations. The distal end portion may comprise a portion distal of the distal end of the rail shaft 120 in some implementations.

[0490] In some implementations, the height pull tether may be configured to engage the adaptor for the mid shaft or intermediate shaft in some implementations. The height pull tether may be retracted in a similar manner as disclosed herein.

[0491] Other methods may be utilized to produce a height of an elongate shaft assembly of a delivery system. Referring to FIG. 58, in some implementations, a method may include retracting a nose body 540 of an elongate shaft assembly 542. The elongate shaft assembly 542 may be configured similarly as the elongate shaft assembly 12 unless stated otherwise. The nose body 540 may be configured similarly as the nose body 142 unless stated otherwise.

[0492] As represented in FIG. 58, the nose body 540 may be retracted at a time that anchors 544 of a treatment device or another portion of a device have been deployed from the capsule 546. The portion of the device that has been deployed may comprise a contact surface for the nose body 540 to retract against. The nose body 540 may retract via a tension in the nose body shaft 548. An actuator assembly 320 as shown in FIG. 25, for example, may be utilized to retract the nose body shaft 548. The nose body 540 may retract and press against the device to provide a retraction force against the elongate shaft assembly 542. Height of the elongate shaft assembly 542 results.

[0493] FIG. 59, for example, illustrates a resulting bend of the elongate shaft assembly 542 in a direction opposed to the direction of deployment of the device. The height may be utilized in an arrangement in which the device is being deployed too distal or ventricular and thus retraction or atrial movement of the device is desired to produce height.

[0494] In some implementations, the configuration of the nose body may be varied to increase a size of the nose body. Such a feature may account for a further expanded size of the device for contact with the nose body, or otherwise it being desirable to increase the size of the nose body. Features of device expansion are disclosed in International Application No. PCT / US2020 / 054786, the entire contents of which being incorporated herein by reference.

[0495] FIG. 60A illustrates an implementation of a nose body 550 for being positioned at a distal tip of an elongate shaft assembly. The nose body 550 is expandable in size and is retractable to deflect the elongate shaft assembly in a similar manner as with the nose body 540.

[0496] In the example shown in FIG. 60A, the nose body 550 is inflatable. The nose body 550 includes one or more balloons 552 for expanding the size of the nose body 550. An inflation conduit or fluid conduit 554, for example, may be provided to provide inflation material to the balloons 552. The nose body 550 is shown coupled to a nose body shaft 556 that is adapted to be retracted to retract the nose body 550. The nose body 550 and nose body shaft 556 may further include a guide wire lumen 558 for the guide wire to pass through.

[0497] FIG. 60B illustrates the balloons 552 having been inflated to increase the size of the nose body 550.

[0498] FIG. 61 illustrates the nose body 550 having been expanded in size and configured to contact the device that is deployed or expanded radially outward to a larger size than shown in FIG. 58. The nose body 550 may be retracted towards the capsule 546. The nose body 550 may contact the anchors 544 of the device or another portion of the device to produce a height of the elongate shaft assembly.

[0499] Other mechanisms may be utilized to produce an expansion of the size of the nose body. FIGS. 62A and 62B, for example, illustrate an implementation in which the nose body 560 includes one or more paddles or wings 562. The paddles or wings 562 may be deflected radially outward to expand the size of the nose body 560. In some implementations, an actuation mechanism 564 may be utilized to expand the paddles or wings 562 at a desired time. The actuation mechanism 564, for example, may comprise a shaft 566 adapted to be slid distally or proximally to respectively expand or retract the wings 562 as desired. Other forms of actuation mechanisms may be utilized as desired.

[0500] Other methods may be utilized to produce a height of an elongate shaft assembly of a delivery system. FIGS. 63A-63C, for example, illustrate an implementation in which a guide wire may be retracted to produce a height of the elongate shaft assembly. The guide wire may engage a nose body 570. The nose body 570 may be retractable upon retraction of the guide wire to thus produce the height of the elongate shaft assembly.

[0501] FIG. 63A, for example, illustrates the nose body 570 that is adapted to be positioned at a distal tip of the elongate shaft assembly. The elongate shaft assembly may be configured similarly as the elongate shaft assembly 12 unless stated otherwise. The nose body 570 is adapted to engage a guide wire 572 and is retractable to deflect the elongate shaft assembly upon retraction of the guide wire 572.

[0502] The nose body 570 may include an engagement body 574 for engaging the nose body 570 with the guide wire 572. The engagement body 574 may comprise a snare as shown in FIG. 63A for snaring the guide wire 572, or may have another configuration in some implementations. The nose body 570 may be coupled to a nose body shaft 576 having an interior lumen 578 for the guide wire 572 to extend through.

[0503] FIG. 63B illustrates the guide wire 572 passing through the interior lumen 578, in position to be engaged by the engagement body 574. At a desired time, the engagement body 574 may be actuated to engage with the guide wire 572. FIG. 63C, for example, illustrates an engaged configuration. With the guide wire 572 engaged, the guide wire 572 may be retracted to accordingly retract the nose body 570 and the nose body shaft 576. The retraction of the nose body shaft 576 may produce a deflection of the elongate shaft assembly, to produce the desired height deflection. An actuator assembly or manual retraction of the guide wire 572 may be utilized.

[0504] Other forms of engagement may be utilized in some implementations. FIG. 64A, for example, illustrates a nose body 580 that is shape set to grip the guide wire 572. The nose body 580 may include a shape memory material (e.g., nitinol or another form of shape memory material) to produce a deflected or tortuous lumen 582 for receiving the guide wire 572. The nose body 580 may include a nitinol frame for example, among other configurations.

[0505] In some implementations, the nose body 580 may include a channel 584 for receiving a deflection body 586 for applying a force to the nose body 580 to place it in a straightened or nondeflected configuration as shown in FIG. 64B. The deflection body 586 may comprise a shaft that is pressed distally to straighten the nose body 580. Such a configuration may reduce the deflection of the lumen 582 and allow the guide wire 572 to smoothly pass through as represented in FIG. 64B. At a desired time, the deflection body 586 may be retracted to allow the nose body 580 to return to the shape set deflected or tortuous shape (as represented in FIG. 64C) to grip the guidewire 572 positioned within the lumen 582. The guide wire 572 may then be retracted to apply a force in a similar’ manner as with the nose body 570.

[0506] The nose bodies 570, 580 are adapted to selectively engage the guide wire 572 at a desired time. Upon engagement, the guide wire 572 is retracted to produce a bending of the elongate shaft assembly. In some implementations, the nose bodies 570, 580 may pass through the interior of the device to deflect the elongate shaft assembly.

[0507] The height produced may be utilized in a similar manner as described in regar d to FIGS . 58-62B, namely, the height may be utilized in an arrangement in which the device is being deployed too distal or ventricular and thus retraction or atrial movement of the device is desired to produce height. Further, the height may be produced to navigate to a deployment site upon retraction of the guide wire 572.

[0508] Features described in regard to FIGS. 58-64C may be utilized solely or in combination with any other example herein.

[0509] FIG. 65 illustrates a perspective view of a treatment device configured as an implant in the form of an example prosthetic valve 600 that may be utilized in some implementations herein. The treatment device 600 may comprise a prosthetic heart valve for deployment to a native heart valve of a patient’s body. The prosthetic heart valve may replace the function of a native heart valve. In some implementations, other forms of implants and prosthetic valves may be utilized as desired.

[0510] The prosthetic valve 600 may be configured to be deployed to an annulus of a native valve, which may comprise a native tricuspid valve or a native mitral valve. In some implementations, other implantation locations may be utilized such as within an aortic or pulmonary valve, or in other valves or locations within a patient’s body as desired.

[0511] The prosthetic valve 600 may include a proximal end portion, or upstream end portion, or an inflow end portion 602, and may include a distal end portion, or downstream end portion, or an outflow end portion 604 (marked in FIG. 66), and a length therebetween.

[0512] The prosthetic valve 600 may further include a valve portion, preferably formed by a plurality of prosthetic valve leaflets 606. The valve portion is positioned in a flow channel or passageway for controlling flow through the prosthetic valve 600. The prosthetic valve leaflets606 move between opened and closed states to mimic and replace the operation of native valve leaflets. The leaflets 606 allow flow in a first direction (the outflow direction) and prevent flow in a second direction (the inflow direction). The valve portion is positioned within the passageway of the prosthetic valve 600 for permitting flow of blood through the passageway in one direction, thereby replacing the function of a native heart valve. The prosthetic valve leaflets 606 are made of pericardium, such as bovine or porcine pericardium, or another material as desired. In alternative arrangements, the leaflets are formed of a synthetic (e.g., polymer) material or the valve portion is a mechanical one-way valve.

[0513] The prosthetic valve leaflets 606 may extend radially inward into a flow channel 608 (marked in FIG. 66).

[0514] In some implementations, the valve portion or prosthetic valve leaflets 606 may include a treatment to reduce pannus formation. The treatment may comprise a coating in some implementations. A treatment such as a Resilia™ (Edwards Lifesciences Corp.) may be applied to the valve portion or prosthetic valve leaflets 606.

[0515] The prosthetic valve 600 may include a frame 610 (shown in FIG. 72). The frame 610 may comprise a self-expanding frame sized for deployment within a native heart valve. Referring to FIG. 72, the frame 610 may include an inflow end portion 612 and an outflow end portion 614. The frame 610 may include an inner frame 616 (marked in FIG. 68) and an outer frame 618 (marked in FIG. 70).

[0516] FIG. 66 illustrates a cross-sectional view of the prosthetic valve 600 showing a cross- sectional profile of the inner frame 616. The inner frame 616 includes a proximal or inflow end portion 620 and a distal or outflow end portion 622. The inner frame 616 may protrude radially outward at the inflow end portion 620 and may be curved radially outward from the inflow end portion 620 towards the outflow direction. The inner frame 616 accordingly may have a bulb shape or curved shape at the inflow end portion 620. The outflow end portion 622 may curve radially inward in the outflow direction such that the end struts of the outflow end portion 622 extend at an angle radially inward.

[0517] Referring to FIG. 68, the inner frame 616 (or inner support stent) may include a plurality of struts 624 spaced from each other with spaces 626. The plurality of stmts 624 form a lattice structure comprising expandable and collapsible cells. Such a configuration may allow theinner frame 616 to move between an undeployed, unexpanded, or linearized configuration to a deployed or expanded configuration. For example, the inner frame 616 may expand radially outward to move to the deployed or expanded configuration, with the length of the inner frame 616 decreasing due to the increased diameter of the inner frame 616. Other configurations of inner frames 616 may be utilized as desired.

[0518] The inner frame 616 may include an outer surface 628 or outward facing surface and may include an inner surface 630 or inward facing surface (marked in FIG. 66). The outer surface 628 may face outward from the flow channel 608 and the inner surface 630 may face towards the flow channel 608. The inner frame 616 supports the prosthetic valve leaflets 606. The prosthetic valve leaflets 606 are positioned within an interior of the inner frame 616.

[0519] A skirt 632 (marked in FIG. 66) may be positioned on the inner frame 616 in some implementations. The skirt 632 may be configured to impede fluid flow therethrough, to impede lateral fluid flow through the flow channel 608 and promote axial flow through the flow channel 608.

[0520] In some implementations, the skirt 632 may be configured for the one or more prosthetic valve leaflets 606 to couple to. For example, a suture line 634 (marked in FIG. 65) or stitch line between the prosthetic valve leaflets 606 and the skirt 632 may couple the prosthetic valve leaflets 606 to the skirt 632. The suture line 634 or stitch line may have a curved or acuate shape to account for the shape of the prosthetic valve leaflets 606.

[0521] Referring to FIG. 65, the prosthetic valve 600 may include one or more anchors 640 that may be configured to anchor the prosthetic valve leaflets 606 to a portion of a patient’s heart, which may comprise a native valve. The anchors 640 may particularly be configured to anchor to the native valve leaflets of the patient’s heart. The anchors 640 may extend around the native valve leaflets to anchor to the native valve leaflets. The anchors 640 may comprise distal anchors positioned at the distal or outflow end portion 604 of the valve 600, or in some implementations may be provided in another position as desired. The anchors 640 may comprise anchors (e.g., ventricular anchors, atrial anchors, other anchors, etc.) extending from portion of the frame (e.g., from an outflow portion of the frame, from an inflow portion of the frame, etc.) of the treatment device and shaped for capturing native leaflets of a native heart valve between the anchors 640 and the outer frame 618.

[0522] One, some, or all of anchors 640 may be configured as a protruding arm configured to extend distally and then curve in a proximal direction to the tip of the respective one of the anchors 640. Such a configuration may allow the anchor 640 to extend around a native leaflet and around the distal tip of the leaflet, to hook over the distal tip of the native valve leaflet and be positioned radially outward of an outward facing surface of a leaflet of the native valve. The anchors 640 may be hook shaped and configured to be in a hooked configuration as shown in FIGS. 65-69 for example. The anchors 640 may thus resist a force applied in the atrial or proximal direction to the prosthetic valve 600 and may anchor the prosthetic valve 600 within the native valve annulus. Other configurations of anchors 640 may be utilized in some implementations as desired.

[0523] The anchors 640 are shown in FIGS. 65-67 in a deployed or expanded configuration, in which the tips of the anchors 640 extend proximally. In some implementations, the anchors 640 may be configured to be in undeployed, unexpanded, or linearized configuration in which the tips of the anchors 640 extend distally. Upon deployment, the anchors 640 may be configured to move from the undeployed configuration radially outward to the deployed configuration, with the tips flipped towards the proximal direction. Such an operation may allow the anchors 640 to flip over the native valve leaflets to anchor to the native valve leaflets during deployment. Such a configuration is represented in FIG. 44 for example. An expansion and deployment sequence may be disclosed in International Application No. PCT / US2023 / 085391, with an international filing date of December 21, 2023 and titled “SYSTEMS, APPARATUSES, AND METHODS FOR PROSTHETIC VALVES,” the entire contents of which are incorporated herein by reference. Other deployment methods for the anchors 640 may be utilized in some implementations as desired.

[0524] The anchors 640 may each extend radially outward from the flow channel 608 and radially outward from the prosthetic valve leaflets 606 of the prosthetic valve 600. The anchors 640 may be configured to extend radially outward from the inner frame 616 and across a gap 642 (marked in FIG. 66) between the inner frame 616 and the outer frame 618. The anchors 640 may each extend to a tip 644 of the respective anchor 640. The anchors 640 may be coupled to a distal end portion or outflow end portion 622 of the inner frame 616. The anchors 640 may each include a proximal portion 646 and a distal portion 648, with the proximal portion 646 coupled to the inner frame 616 and the distal portion 648 comprising a tip of the respective anchor 640. The anchors640 may extend vertically from the proximal portion 646 to the tip at the distal portion 648 when the valve 600 is deployed.

[0525] Referring to FIG. 68, one, some, or all of anchors 640 may include a stmt arm 650 having the shape of the resulting anchor 640. The strut arm 650 may be integral with the inner frame 616 and cut from the same material as the inner frame 616. Each stmt arm 650 may include an opening 652 at its tip for reducing the material of the tip. The opening 652 may be enclosed by the material of the strut arm 650 (e.g., a fully bounded opening 652).

[0526] Referring to FIG. 66, each stmt arm 650 may be covered with material that may comprise a fabric material or other form of compliant material. For example, a padding layer 654 may be provided at the tip 644 of the anchor 640. The padding layer 654 may comprise a foam or may comprise a woven material that provides a cushion. For example, a woven material comprising a honeycomb weave that is heat treated to increase a cushion of the material may be utilized. In some implementations, one or more sleeves 656 may be provided to further cushion and cover the strut arm 650 and may cover the padding layer 654 or other form of cushion material. Anchors 640 including the coverings are illustrated in FIG. 65.

[0527] Referring to FIG. 65, the prosthetic valve 600 may include an outer sealing body 660. The sealing body 660 may be positioned radially outward from the prosthetic valve leaflets 606 and may be configured to seal against a portion of the native valve. The sealing body 660 may comprise the outer surface of the prosthetic valve 600. The sealing body 660 may define the outer diameter of the prosthetic valve 600 and may comprise the outer periphery of the prosthetic valve 600. The sealing body 660 may include a proximal end portion or inflow end portion 662 and a distal end portion or an outflow end portion 664.

[0528] Referring to the cross-sectional view of FIG. 66, the sealing body 660 may include the outer frame 618 and a sealing skirt 668. The outer frame 618 (or outer support stent) is positioned radially outward from the inner frame 616.

[0529] The outer frame 618 comprises at least a portion of the sealing body 660 that is configured to apply a seal to a portion of a heart. The outer frame 618 may have a proximal or inflow end portion 670 (marked in FIG. 70). The inflow end portion 670 may include couplers 672 for coupling with complementary couplers 675 on the inflow end portion of the inner frame 616 (marked in FIG. 68). The outer frame 618 may further include tabs 673 (marked in FIG. 70)or other forms of couplers for engaging with an inner retention member 50 of a delivery system.Other forms of couplers (c.g., eyelets) may be utilized as desired.

[0530] The outer frame 618 may protrude radially outward from the inflow end portion 670 to form a plateau portion 674 that extends radially outward to a shoulder 676 of the outer frame 618. The shoulder 676 may comprise an angulation of the outer frame 618 that transitions between the radially extending plateau portion 674 and an axially extending portion 678. The axially extending portion 678 may extend in the distal or outflow direction to an outflow end portion 680 of the outer frame 618.

[0531] The outflow end portion 680 of the outer frame 618 may be spaced from the inner frame616 with the gap 642.

[0532] The outer frame 618 may include an outer surface 682 or outward facing surface and may include an inner surface 684 or inward facing surface. The outward facing surface may face outward from the flow channel 608 and the inward facing surface may face towards the flow channel 608. The outer surface 682 is for pressing against and sealing against tissue of the native heart valve.

[0533] FIGS. 70 and 71 illustrate a strut pattern of the outer frame 618. The outer frame 618 includes a plurality of struts 686 forming the outer frame 618, with openings 688 between the struts 686. The plurality of stmts 686 form expandable and collapsible cells. Such a configuration utilized with the outer frame 618 allows the outer frame 618 to move between an undeployed, unexpanded, or linearized configuration to a deployed or expanded configuration as shown in FIGS. 70 and 71. The struts 686 form a lattice structure. The outer frame 618 and inner frame 616 may both be self-expanding, and may be made from a shape memory material. The shape memory material may comprise nitinol or may comprise another material in some implementations. In some implementations, other forms of expandable frames (e.g., balloon expandable or mechanically expandable) may be utilized.

[0534] The strut pattern includes openings 688 that arc bounded entirely by the struts 686 and openings 690 that are partially bounded by the struts 686. The strut pattern has an outflow end 692, and the struts forming the outflow end 692 bound the partially bounded openings 690. Struts 694a and 694b, for example, are at the outflow end 692 of the stmt pattern and bound the opening 690.

[0535] An elongate beam 700 extends from the juncture of the stmts 694a and 694b. A plurality of the elongate beams 700 arc provided as shown in FIGS. 70 and 71. The elongate beams 700 may each have a proximal end portion 701 coupled to at least one of the plurality of struts of the outer frame 618 and each extending in an outflow direction to a tip 704 of a respective one of the elongate beams 700.

[0536] Each elongate beam 700 extends from a juncture of stmts such as struts 694a and 694b that are at the outflow end 692 of the stmt pattern and bound an opening 690. The elongate beams 700 extend axially in an outflow direction from a respective juncture. The elongate beams 700 extend within the opening 690 and are bound on their sides by the stmts 694a and 694b. The elongate beams 700, however, extend axially to a lesser length than the position of the distalmost tips 706, end, or terminus of the outer frame 618. In some implementations, the elongate beams 700 comprise fixation elements for improving fixation with the leaflets captured by the anchors 640.

[0537] FIG. 66 illustrates that the elongate beams 700 protrude radially outward from the outer surface 682 of the outer frame 618.

[0538] The sealing body 660 may include the sealing skirt 668, which may be coupled to the outer frame 618 of the sealing body 660. The sealing skirt 668 may extend along the outer frame 618. The sealing skirt 668 may cover the outer surface 682 of the outer frame 618 and cover an outer surface of the elongate beams 700. As such, the strut arrangement shown in FIGS. 70 and 71 may be covered by the sealing skirt 668. The elongate beams 700 may be positioned interior of the sealing skirt 668 and in some implementations do not protrude through the sealing skirt 668.

[0539] The sealing skirt 668 may be made of a material that resists fluid flow therethrough, such as a cloth material, woven material, or other material such as a polymer or other material that resists fluid flow therethrough. The material may comprise a fabric. A variety of materials may be utilized for the skirt 668 as desired. In some implementations, referring to FIGS. 65 and 67, the sealing skirt 668 may be made of segments that are stitched or otherwise joined together with vertical or axial seams 710. The vertical or axial seams 710 may reduce the prevalence of bunching of the skirt material upon moving to a compressed or undeployed configuration.

[0540] The sealing body 660 may be configured to abut a portion of the patient’s heart to reduce fluid flow. The sealing skirt 668 may be configured to seal a portion of the native valveannulus. For example, the sealing body 660 may abut a surface of a patient’s native valve leaflet to reduce fluid flow between the scaling body 660 and the native leaflet. The scaling body 660 may be configured to abut other portions of the patient’s heart to reduce fluid flow as desired.

[0541] The sealing body 660 may be flexible to allow for movement and conformability to a native valve annulus.

[0542] The anchors 640 and the fixation elements or elongate beams 700 may be utilized to secure the heart valve 600 within the native heart valve. FIG. 66, for example, illustrates a cross- sectional view showing the relative positions of the elongate beams 700 and the anchors 640. The anchors 640 are adapted to press a native valve leaflet against a respective one of the elongate beams 700 for securing the prosthetic heart valve 600 within the native heart valve. FIG. 66 illustrates an opposed position between the anchors 640 and the elongate beams 700. The anchors 640 and the elongate beams 700 may have the same circumferential spacing such that the position of each anchor 640 corresponds to a position of an elongate beam 700.

[0543] FIG. 72, for example, illustrates an assembled view of the outer frame 618 and the inner frame 616, with the relative positions of the elongate beams 700 and the anchors (with the strut arms 650 of the anchors shown in FIG. 72).

[0544] FIG. 73 illustrates a side view of the orientation of an anchor 640 relative to an elongate beam 700. The elongate beam 700 may include an arm 702 that extends distally or in the outflow direction to the tip 704 of the elongate beam 700. The tip 704 may comprise a free tip or terminus of the elongate beam 700 that is not directed connected to another structure. The elongate beam 700 may comprise a prong extending from the juncture of the struts 694a, b.

[0545] The arm 702 may have a width 711. The tip 704 may include a head 712 having a width 714 that is greater than the width 711 of the arm 702. As such, the head 712 may comprise a wider body than the arm 702. The head 712 may comprise a smooth outer surface in some implementations and may lack serrations or other ridged frictional structures or barbs for engaging the native valve leaflet.

[0546] The tip 644 or head of the anchor 640 is circumferentially aligned with the tip or head 712 of the elongate beam 700. Further, the tip 644 or head of the anchor 640 is axially aligned with the tip or head 712 of the elongate beam 700 as represented in FIG. 73. Such a configurationallows for a compressive or pinching force between the tip 644 or head of the anchor 640 and the tip or head 712 of the elongate beam 700. A leaflet may be pressed between such structures to improve a securement of the leaflet at such a position.

[0547] In some implementations, the elongate beams 700 may be biased to apply a force against the anchors 640. FIG. 74, for example, illustrates an overlay of the outer frame 618 relative to the inner frame 616 without full assembly of prosthetic valve 600. The outer frame 618 is formed such that the elongate beams 700 form the largest diameter 720 of the outer frame 618, larger than the diameter 722 of the shoulder 676. The elongate beams 700 are shown to flare radially outward.

[0548] FIG. 75 illustrates a representation of the outer frame 618 joined with the inner frame 616 in an assembled state of the prosthetic valve 600 (with fabric and padding applied to the strut arms 650). The outer frame 618 is pressed radially inward by the anchors 640 and the elongate beams 700 apply a load or force to the anchors 640. The outer frame 618 has been drawn inward such that the diameter 720 at the elongate beams 700 matches the diameter 722 at the shoulder 676. The outer frame 618 thus has a cylindrical shape from the shoulder 676 to the elongate beams 700. A native leaflet positioned between the elongate beams 700 and the anchors 640 presses the elongate beams 700 inward to apply a compressive securing force to the native valve leaflet.

[0549] The cylindrical shape of the outer frame 618 further may delay radially outward expansion of the outer frame 618 upon deployment (e.g., a delayed expansion upon retraction of a capsule). The delayed expansion may be desirable because a larger capture window for leaflets may be provided between the anchors 640 and the capsule until the capsule is fully retracted.

[0550] In some implementations, if the outer frame 618 is sized smaller (with a smaller diameter) than the native valve annulus, then the elongate beams 700 may aid in securement to the native valve leaflets. If the outer frame 618 is sized larger (with a larger diameter) than the native valve annulus, then the native valve annulus may press the outer frame 618 inward. The elongate beams 700 may disengage from the leaflets due to the inward force provided by the annulus, yet the force applied by the annulus may further secure the prosthetic valve 600 in position and may reduce the need for use of the elongate beams 700.

[0551] Other configurations of the prosthetic valve 600 may be provided based on a size of the native valve or native valve annulus for implantation. FIG. 76, for example, illustrates animplementation of an inner frame 730 having anchors 732 that curve radially inward to account for a smaller size of an annulus for deployment. The radially inward curvature may approach an elongate beam 740 of an outer frame 742 as represented in FIG. 77. A treatment device as represented in FIG. 77 may otherwise include the features of the prosthetic valve 600.

[0552] In some implementations, the use of the elongate beams 700 may be excluded.

[0553] In some implementations, the anchors 640 may be adapted to provide an outward- radial force for added securement to the native anatomy. For example, an outward force to a ventricle (e.g., a right ventricle for a tricuspid deployment) may be provided.

[0554] Other modifications of the prosthetic valve 600 may be provided as desired. FIG. 78, for example, illustrates an implementation in which the anchors 640 arc unequally spaced from each other. Such a configuration is an implementation of the configuration shown in FIG. 67, in which the anchors are equally spaced from each other and can include similar features.

[0555] In a configuration as shown in FIG. 78, an anchor has been excluded or the device does not include an anchor at a section 750 of the outer circumference of the prosthetic valve. In some implementations, the section 750 may correspond to the position of where an equally spaced anchor would have been positioned if the equal spacing positioning of the remaining anchors 640 were maintained. In some implementations, the section 750 lacks one of the anchors 640 at the equal spacing positioning of the anchors 640 that are within the remaining section 752 of the outer circumference.

[0556] In some implementations, the section 750 may be defined as an angle of the outer circumference. For example, the section 752 having the anchors 640 may extend for at least 180 degrees of the outer circumference, or at least 220 degrees of the outer circumference, or at least 260 degrees of the outer circumference. The section 752 having the anchors may extend for at least 320 degrees of the outer circumference in light of nine equally spaced anchors 640 being present in a configuration as shown in FIG. 67, yet with the ninth anchor removed thus leaving eight anchors 640 in FIG. 78. The remaining anchors 640 may be equally spaced in the section 752 (as shown in FIG. 78) or may be unequally spaced within the section 752 in some implementations .

[0557] In some implementations, the section 750 or gap in the outer circumference may be positioned to account for a portion of the heart or heart valve annulus that preferably lacks the presence of one of the anchors 640. For example, in a tricuspid deployment, a septal leaflet may preferably lack an anchor 640 at that position because of potential electrical conduction disturbance issues stemming from the presence of an anchor 640. An anchor may be excluded at the section 750 to reduce the potential for electrical conduction disturbance issues or the possibility of pseudo aneurysms at the location of the Bundle of His. Positioning section 750 in the region of a nerve bundle or node may help avoid conduction issues that might potentially be caused by an anchor pushing into the nerve bundle or node. Other configurations may be utilized in some implementations. In some implementations, anchors may be unequally spaced within the section 752. Hook anchors or other forms of anchors (e.g., latches, flaps, clips, clamps, barbs, arms, extensions, etc.) may be utilized as desired.

[0558] FIG. 79 illustrates an implementation in which a treatment device depicted, for illustrative purposes, as prosthetic valve 760 includes unequally spaced anchors 762 in a similar manner as the anchors 640 shown in FIG. 78. FIG. 80, for example, illustrates a top cross-sectional schematic view showing the relative positions of the anchors 762. The anchors 762 are shown positioned about the outer circumference of the prosthetic valve 760, relative to the sealing body 764.

[0559] In some implementations, the anchors 762 are unequally spaced from each other. Such a configuration is variation of the configuration shown in FIG. 67, in which the anchors are equally spaced from each other.

[0560] In a configuration as shown in FIG. 80, an anchor has been excluded or the device does not include an anchor at a section 766 of the outer circumference of the prosthetic valve. The features of the anchors 640 described in regard to FIG. 78, including the spacing of the anchors 640, applies to the anchors 762 of FIGS. 79 and 80. A difference of the prosthetic valve 760 is that a first anchor 762a and a second anchor 762b that bound the section 766 of the outer circumference each extend to a lesser axial height in the inflow direction of the prosthetic valve 760 than at least one other of the anchors 762. In some implementations, the anchors 762a, b may have a lesser axial height in the inflow direction than each of the remaining anchors 762.

[0561] The top cross-sectional schematic view of FIG. 80 illustrates the anchors 762a, b bounding the section 766 at which an anchor is excluded. The size of the section 766 may be the same size as described in regard to the prosthetic valve 751 of FIG. 78.

[0562] Such a feature may produce a larger overall section at which the anchors 762 have a reduced presence. In a tricuspid deployment, the section 766 may be utilized to reduce the possibility of electrical conduction disturbance issues stemming from the presence of an anchor at the septal leaflet.

[0563] In some implementations, the reduced height of the anchors 762a, b may be utilized in the possibility that an imprecise rotational deployment of the prosthetic valve 760 occurs, and the section 766 is not precisely angled or oriented towards the septal leaflet. The reduced height of the anchors 762a, b may reduce the impact of the size of the anchors 762 towards the septal leaflet if an imprecise rotational deployment occurs (e.g., the section 766 is not directly aligned with the septal leaflet). Other configurations may be utilized in some implementations, and the above and other configurations may be used in other locations in the body.

[0564] In some implementations, the reduced axial height of the anchors 762a, b may be provided in a variety of manners. In some implementations, the overall length of the anchors 762a, b may be less or reduced to produce shorter anchors 762a, b or anchors having a lesser axial height than the remaining anchors 762.

[0565] FIG. 81 illustrates an implementation in which the anchors 762 each include a drop loop 770, and the drop loop 772 of the anchor 762a protrudes axially in an outflow direction relative to the drop loops 770 of the remaining anchors 762. The anchor 762b may include a similar configuration. The lesser height of the drop loop 772 is indicated by reference number 774. Such a configuration maintains an overall length of each of the anchors 762, 762a, 762b, yet reduces a height of the tips of the anchors 762a, b (as indicated by reference number 776). As such, a corresponding reduction in the height of the tip without a corresponding or equal reduction in the length of the anchor results.

[0566] In some implementations, the heights of the anchors 762a, b may be offset such that the tips 779a, b (marked in FIG. 79) of the anchors 762a, b extends to a lesser axial height in a proximal direction (or inflow direction) than the tips 781 of the remaining anchors.

[0567] In some implementations, the configuration of the anchors 762, 762a, 762b, represented in FIGS. 79-81 may be utilized in combination with the features of the device or prosthetic valve 600 disclosed herein. In some implementations, the use of the elongate beams 700 may be excluded at the section 766 (or the corresponding section 750 shown in FIG. 78). In some implementations, the elongate beams 700 may be utilized at the anchors 762a, b or may be excluded from use as desired.

[0568] In a configuration represented in FIGS. 79-81, the need for precise and active clocking of the treatment device or prosthetic valve may be reduced because the lower height anchors 762a, b may provide a wider area (e.g., an area or circumference of three standard anchors) at which placement against a septal leaflet may occur. Increased simplicity of deployment may result due to a larger outer circumference of the treatment device having no or reduced height anchors. A reduced possibility of interaction with electrophysiology of the right side of the heart, namely the Bundle of His or other structures may result.

[0569] Other forms of treatment devices may utilize a configuration as represented in FIGS . 79-81. For example, treatment devices or implants as disclosed in International Application Nos. PCT / US2023 / 085391 or PCT / US2020 / 054786 may include the features of FIGS. 79-81, or FIGS. 65-78, as desired. A treatment device as disclosed in International Application Nos. PCT / US2023 / 085391 or PCT / US2020 / 054786 may include unequally spaced anchors, and may lack anchors at a section of the outer circumference of the treatment device, among other features disclosed herein. A treatment device as disclosed in International Application Nos. PCT / US2023 / 085391 or PCT / US2020 / 054786 may include anchors having a reduced axial height bounding a section, among other features disclosed herein. The position of the section may be aligned with a septal leaflet of a tricuspid valve, as disclosed herein. Other uses of such a section may be utilized as desired. Each of the above references is incorporated by reference herein in their entirety for all purposes.

[0570] Other forms of treatment devices (e.g., other forms of prosthetic heart valves, implants, repair devices, etc.) can be utilized as desired.

[0571] FIG. 82, for example, illustrates a treatment device depicted, for illustrative purposes, as a prosthetic valve 820 that may incorporate features as disclosed herein. Features of the prosthetic valve 820 are disclosed in PCT / US2023 / 085391, the entire contents of which areincorporated herein by reference. The prosthetic valve 820 may include a frame, including an outer frame 822 as represented in FIG. 83. The outer frame 822 may form a portion of outer sealing body 821 as marked in FIG. 82. The frame of the prosthetic valve 820 may include an inner frame 824 as represented in FIG. 84. A plurality of anchors 826 (e.g., ventricular anchors, etc.) are coupled to the inner frame 824 (e.g., nine anchors 826 are shown in FIG. 84, although a greater or lesser number may be utilized).

[0572] The prosthetic valve 820 may include any of the features disclosed in PCT / US2023 / 085391. For example, the prosthetic valve 820 may include one or more grip features 828 that may operate in a similar manner as disclosed in PCT / US2023 / 085391. For example, the grip features 828 may engage the native valve leaflets to reduce movement of the native valve leaflets relative to the prosthetic valve 820. The grip features 828 may comprise barbs that cooperate with the anchors 826 to secure the prosthetic valve 820 in position, as disclosed in PCT / US2023 / 085391. The prosthetic valve 820 may include other features, such as a flexible body, connecting member, connecting skirt or intermediate component 830 that may extend between the inner frame 824 and the outer frame 822 as disclosed in PCT / US2023 / 085391. The intermediate component 830 may allow the outer frame 822 to move axially or tilt with respect to the inner frame 824. The prosthetic valve 820 may further incorporate any of the features disclosed herein.

[0573] For example, referring to FIG. 85, the inner frame 824 may be modified to produce an inner frame 832 as shown in FIG. 85 and lacking an anchor 826 at a section 834 of the inner frame 832. Eight unequally spaced ventricular anchors 826 remain (with the ninth ventricular anchor excluded). The resulting treatment device may have an arrangement and position of anchors as represented in FIG. 78. Other modifications may be utilized (e.g., a greater number of anchors may be excluded, or the configurations of the remaining anchors may be altered as desired).

[0574] In some implementations, at least a portion of a treatment device may include one or more imaging markers. The imaging markers may be configured to indicate a position of a section of a treatment device such as a section 834 as shown in FIG. 85. The imaging markers may be positioned in a variety of locations on the treatment device as desired.

[0575] Referring to FIG. 86, the one or more imaging markers may be positioned on a frame of a treatment device. The one or more imaging markers may be positioned on an outer frame, ormay be positioned on an inner frame, and / or on one or more anchors. FIG. 86 illustrates the inner frame 832 shown in FIG. 85, with padding and other coverings of the anchors 826 removed to expose the stmt arms 836 of the anchors 826.

[0576] The inner frame 832 may include a first anchor 838a and a second anchor 838b (among the other anchors 826 shown in FIG. 86). The first anchor 838a is adjacent to the section 834, and the second anchor 838b is adjacent to the first anchor 838a such that the first anchor 838a is circumferentially between the section 834 and the second anchor 838b. The anchors 838a, b are circumferentially adjacent to each other, with the first anchor 838a positioned between the second anchor 838b and the section 834.

[0577] The first anchor 838a includes a first imaging marker 840a and the second anchor 838b includes a second imaging marker 840b. The remaining anchors 826 may lack imaging markers or may include one or more imaging markers as desired. The first anchor 838a may be positioned on a strut arm 842a of the first anchor 838a and the second anchor 838b may be positioned on a strut arm 842b of the second anchor 838b.

[0578] In some implementations, the first imaging marker 840a may have a different length than the second imaging marker 840b. For example, the first imaging marker 840a has a greater length than the second imaging marker 840b. The first imaging marker 840a extends for a greater length along the strut arm 842a than the corresponding second imaging marker 840b along the respective stmt arm 842b. The different lengths may be able to be imaged through forms of medical imaging (e.g., fluoroscopy, or other forms of medical imaging). In some implementations, the imaging markers may comprise fluoroscopic markers (although other forms of markers such as echogenic markers or other forms of markers may be utilized as desired). Radiopaque markers may be utilized. The markers 840a, b may be positioned to provide a visual key for the location of the section 834.

[0579] FIG. 87 illustrates a top cross-sectional representation of the position of anchors 826, 838a, b resulting from use of a frame 832 as shown in FIG. 86. The position of the anchors 826, 838a, b relative to the outer sealing body 821 is shown. Similar to the example shown in FIG. 78, the anchors 826, 838a, b are unequally spaced about an outer circumference of the treatment device. The outer circumference includes a section 844 having a circumferential spacing between adjacent anchors 838a and 826a that is larger than another circumferential spacing between twoadjacent anchors (e.g., anchors 838a, b) of the anchors 826, 838a, b. Similar to the example of FIG. 78, the section 844 may correspond to the position of where an equally spaced anchor would have been positioned if the equal spacing positioning of the remaining anchors 826, 838a, b were maintained. The section 844 lacks one of the anchors 826, 838a, b at the equal spacing positioning of the anchors 826, 838a, b that are within the remaining section 846 of the outer circumference. The sections 844, 846 may have a relative sizing as disclosed herein. Eight anchors 826, 838a, b may remain (although a greater or lesser number may be utilized as desired).

[0580] The imaging markers of the anchors 838a, b may be utilized to indicate the position of the section 844.

[0581] For example, referring to FIG. 88, imaging of a resulting treatment device may occur during a deployment procedure. The treatment device may be in a compressed, undeployed, or unexpanded configuration and may be positioned within a device retention area of a delivery system. In FIG. 88, the treatment device is compressed within a capsule 38 as disclosed herein. In such a configuration, medical imaging of the treatment device and delivery system may occur. Fluoroscopic imaging (e.g., x-ray imaging) is represented in FIG. 88. The imaging markers 840a, b are imaged and may be visualized during the procedure. The position of the section 844 shown in FIG. 87 may be determined through imaging of the imaging markers 840a, b.

[0582] The appearance of the imaging markers 840a, b under visualization indicates the position of the section 844. Different lengths or other imaging characteristics of the imaging markers 840a, b may be utilized to indicate the position of the section 844. In an example in which the imaging markers 840a, b have different lengths as shown in FIG. 86, a “T” shaped appearance, with the long marker 840a positioned above or central to the short marker 840b may be desirable to indicate that the section 844 is above the long marker 840a. Aligning the long marker 840a with the guide wire may rotate the treatment device to an approximately correct or desired position.

[0583] FIG. 89, for example, illustrates an imaging arrangement including a source 850 (e.g., an x-ray source or other source for medical imaging) and a detector 852. The detector 852 may be utilized to visualize the relative positions of the anchors 838a, 838b to determine the position of the section 844. The treatment device accordingly may be rotated about its axis to position the section 844 at a desired location, such as a position of the septal leaflet and the Bundle of His 854. The first imaging marker 840a may be for a septal anchor 838a, and the second imaging marker840b may be for a septal-posterior anchor 838b in some implementations. Other configurations may be utilized in some implementations. Greater confirmation may be provided that the section 844 is rotationally oriented at the desired position for implantation.

[0584] The visualization may occur prior, during, or after expansion of the treatment device. Visualization prior to or during an expansion procedure may be utilized to actively rotate the treatment device and / or the delivery system prior to full expansion of the treatment device. Confirmation may be provided that the treatment device has been properly pre-loaded prior to anchor deployment. Visualization after a procedure may be utilized to determine if the treatment device is rotationally oriented within a native valve annulus in the desired position. Other uses may be provided in some implementations.

[0585] In some implementations, other forms of imaging markers may be utilized, or other positions of imaging markers may be utilized. For example, positions upon different portions of a frame (e.g., an outer frame) or upon skirt material may be utilized. In some implementations, imaging markers upon a portion of a delivery system may be utilized to determine a desired rotational orientation of a treatment device. In some implementations, a single imaging marker may be utilized. A single imaging marker or multiple imaging markers may have an asymmetric shape (e.g., a single “T” shape or “D” shape, among other shapes) to indicate the position of the section 844. Other shapes may be utilized in some implementations.

[0586] The features of FIGS. 82-89 may be utilized with any example disclosed herein. Any form of treatment device disclosed herein may utilize one or more imaging markers or include another feature of a treatment device disclosed in regal’d to FIGS. 82-89.

[0587] In some implementations, features of a delivery system may be configured to indicate the rotational position or orientation of a treatment device relative to the delivery system. FIG. 90A, for example, illustrates a perspective view of the inner retention member 50, including an indicator 860 for indicating a rotational orientation of the treatment device relative to the inner retention member 50. In some implementations, the indicator 860 may comprise a notch or may have another form in some implementations.

[0588] In some implementations, during a loading procedure for the treatment device to the inner retention member 50, the indicator 860 may be utilized to rotationally align a section of the treatment device (such as a section 844 or other form of section as disclosed in FIGS. 78-89 orFIGS. 101-107) with the inner retention member 50. In some implementations, the indicator 860 may comprise a visual indicator for a technician to use to properly align the treatment device relative to the inner retention member 50. In some implementations, an indication of a missing anchor or section of the valve lacking an anchor may be provided in some implementations, and may aid in rotationally placing the missing anchor section in some implementations. FIG. 90B illustrates an implementation of an indicator 862 on an inner retention member 864. The indicator 862 may comprise a deeper cut-out or notch than represented in FIG. 90A. Such a feature may provide enhanced visibility upon coupling of the treatment device to the inner retention member 864. Other forms of indicators (e.g., markings or structures) may be utilized in some implementations .

[0589] Other portions of a delivery system may include an indicator in some implementations. FIGS. 91 and 92, for example, illustrate an indicator 871 positioned on a mid shaft or intermediate shaft (which may be configured similarly as the intermediate sheath or shaft 40, or other form of intermediate sheath or shaft disclosed herein). The indicator 871 comprises a line marking positioned on the outer retention member or ring 872 (corresponding to the outer retention member or ring 46). The indicator indicates a rotational orientation of the treatment device 876 relative to the intermediate shaft. The indicator 871 may be utilized to indicate the position of a section 874 of a treatment device 876, with the section 874 configured similarly as the section 844 or other form of section as disclosed in FIGS. 78-89 or FIGS. 101-107. An indication of a missing anchor or section of the valve lacking an anchor may be provided in some implementations, and may aid in rotationally placing the missing anchor section in some implementations.

[0590] The indicator 871 may be utilized in a loading or crimping procedure for the treatment device 876, as represented in FIG. 92. A technician may align the indicator 871 with the section 874 upon a crimping or loading procedure to confirm that the section 874 is in a defined rotational orientation relative to the intermediate shaft. Other forms of indicators may be utilized in some implementations .

[0591] Referring to FIG. 93, an underlying hypotube 878 of the outer retention member or ring 872 may include an indicator 881 for indicating the position of the indicator 871. As such, during a manufacturing process for the delivery system, a manufacturer may position the indicator 871 over the underlying indicator 881 and confirm the desired position of the indicator 871.

[0592] The features of FIGS. 90A-93 may be utilized with any other example herein.

[0593] In some implementations, a delivery system may be configured to produce rotation of an inner retention member 50. A rotation mechanism or rotation control may be provided, which can be configured in a variety of ways. For example, FIG. 94 illustrates a perspective view of the body 870 including the coupler 310 for engaging the proximal end portion of the inner shaft 130. The body 870 is shown to comprise an elongate body extending within the interior cavity 326 of the delivery housing 232. The coupler 310 is shown to comprise a flanged disk. In some implementations, the body 870 may be provided and / or configured to produce controlled actuation of the rotation of the inner retention member 50.

[0594] FIG. 95, for example, illustrates an implementation in which the body 880 is configured to rotate about the axis of the delivery housing 232. The body 880 includes a coupler 882 configured similarly as the coupler 310. Rotation of the body 880 produces a rotation of the inner shaft 130, which accordingly rotates the inner retention member 50 about the longitudinal axis 9 (marked in FIG. 1) of the elongate shaft assembly. In some implementations, the coupler 882 may include one or more channels 884 cut to allow for passage of the proximal or height pull tether 194 therethrough upon rotation of the body 880 and coupler 882. The channel 884 may have an arcuate shape as shown in FIG. 95 or may have another shape in some implementations.

[0595] The rotation of the body 880 may be controlled with an actuator such as a control knob 886 in some implementations. The body 880 may be rotated during a crimping or loading procedure to provide a desired rotational position of the inner retention member 50. The body 880 may be rotated during a delivery procedure to provide a desired rotational orientation of the inner retention member 50 and the treatment device during implantation. The location of an indicator 860, 862 as shown in FIGS. 90A and 90B for example may be rotated to be provided at the desired rotational orientation (which may be during a crimping or loading procedure). The features of FIG. 95 may be utilized with any example disclosed herein.

[0596] In some implementations, a nose body assembly may include an alignment body for rotationally aligning a treatment device relative to the alignment body. FIG. 96, for example, illustrates a configuration of an alignment body 900 that may be utilized. The alignment body 900 may include a central body 902 and a fin 904 protruding radially outward from the central body902. In some implementations, the central body 902 may include an interior lumen 906 for a nose body shaft 140 to pass through.

[0597] In some implementations, the fin 904 may beneficially be positioned at a location that lacks an anchor or otherwise corresponds to a section of a treatment device as disclosed herein, such as a section 844 or other form of section as disclosed in FIGS. 78-89 or FIGS. 101-105. In some implementations, the fin 904 is adapted to be positioned between the remaining elongate anchors of the device to rotationally align the device relative to the alignment body 900 as represented in FIG. 96.

[0598] In some implementations, the fin 904 may protrude into the space remaining due to the lack of an elongate anchor (and corresponding to a section 844 or other form of section as disclosed in FIGS. 78-89 or FIGS. 101-105). In some implementations, the fin 904 may be positioned to align the remaining anchors during a crimping or loading process for the treatment device. In some implementations, the fin 904 may remain in position to set a rotational position of the treatment device within a device retention area 16 as shown in FIG. 17. In some implementations, the fin 904 may be fixed in position rotationally and axially to the nose body shaft 140, or may be rotatable or slidable to allow variable positions if, for example, the device should be positioned in a different orientation required by a unique patient anatomy or for a different vascular approach, among other reasons.

[0599] In some implementations, the alignment body 900 may be positioned on the nose body shaft 140. Other positions, such as on the nose body 142 may be utilized in some implementations. The alignment body 900 may comprise a portion of a crimp shield or guide wire shield for the nose body assembly in some implementations, to shield the underlying nose body shaft 140 in a crimping or loading procedure.

[0600] Variations in the configuration of the alignment body 900 may be provided in some implementations. FIG. 97, for example, illustrates an implementation of an alignment body 912 in which the central body 908 abuts a proximal end surface of the nose body 142. The fin 910 is tapered to abut the shape of the proximal end surface of the nose body 142. The alignment body 912 rotationally aligns a device relative to the alignment body 912 in a similar manner as the alignment body 900. FIG. 98 illustrates the fin 910 of the alignment body 912 positioned at a location of a device that lacks an elongate anchor.

[0601] FIG. 99 illustrates an implementation of an alignment body 920 in which the central body 922 is spaced from the proximal end surface of the nose body 142 with the fin 924. As such, a gap 925 is positioned between the distal end of the central body 922 and the proximal end surface of the nose body 142. A distal surface of the fin 924 is tapered to angle to the shape of the proximal end surface of the nose body 142. The alignment body 920 aligns a device relative to the alignment body 920 in a similar manner as the alignment body 900. FIG. 100 illustrates a perspective view of the alignment body 920 illustrating the interior lumen 926 of the central body 922 for receiving the nose body shaft 140.

[0602] In some implementations, the alignment bodies disclosed in regard to FIGS. 96-100 may be slidable longitudinally relative to the nose body shaft 140, or may be static as desired. In some implementations, one or more portions of the alignment bodies may include elongate recesses or channels for receiving a respective elongate anchor. The elongate recesses or channels may extend along the length of the central body or on the fin, and may separate the elongate anchors from each other. A plurality of ribs between the elongate recesses or channels may exist on the central body and / or on the fin. Other variations may be utilized in some implementations.

[0603] In some implementations, the alignment bodies disclosed in regard to FIGS. 96-100 may be utilized during a crimping or loading procedure to improve the symmetry of the anchors of the treatment device in a crimped or loaded configuration. The fins of the alignment bodies, for example, may reduce the possibility of the anchors adjacent to the section that lacks an anchor from bending towards such a section during crimping or loading. The fins may impede such undesired deflection of the anchors. Reduced possibility of damage to the treatment device in a crimping or loading procedure may result.

[0604] The alignment bodies disclosed in regard to FIGS. 96-100 may be utilized in combination with any example disclosed herein.

[0605] FIG. 101 illustrates a configuration of a treatment device 930 that may be utilized in some implementations herein. The treatment device 930 may include a configuration and position of anchors as disclosed in regard to FIG. 78, yet may include an arm 933 positioned at the section 934 corresponding to the section 750 of FIG. 78. The treatment device 930 may otherwise include the features of any other treatment device (e.g., valve, implant, etc.) disclosed herein, including anouter sealing body 936. The treatment device 930 may include an outer frame and an inner frame 938 (as shown in FIG. 102).

[0606] The arm 933 is more clearly shown in FIG. 102. The arm 933 is coupled to the inner frame 938 and extends axially in an outflow direction to a tip 940 of the arm 933. The arm 933 is coupled to a juncture of the struts of the inner frame 938 and extends axially in an outflow direction from such a juncture. The strut arms 942 forming the hook shaped anchors 932 are illustrated in FIG. 102.

[0607] FIG. 103 illustrates a top schematic cross-sectional view of the relative position of the arm 933. The position of the arm 933 and the anchors 932 relative to the outer sealing body 936 is shown. Similar to the example shown in FIG. 78, the anchors 932 are unequally spaced about an outer circumference of the treatment device. The outer circumference includes a section 934 having a circumferential spacing between adjacent anchors 932a and 932b that is larger than another circumferential spacing between two adjacent anchors (e.g., anchors 932b, c) of the anchors 932. Similar to the example of FIG. 78, the section 934 may correspond to the position of where an equally spaced anchor would have been positioned if the equal spacing positioning of the remaining anchors 932 were maintained. The section 934 lacks one of the anchors 932 at the equal spacing positioning of the anchors 932 that are within the remaining section 944 of the outer circumference. The sections 934, 944 may have a relative sizing as disclosed herein. Eight anchors 932 may remain (although a greater or lesser number may be utilized as desired).

[0608] The arm 933 is positioned at a circumferential position corresponding to the section 934. The arm 933 is positioned radially inward of the outer surface of the outer sealing body 936 and accordingly radially inward of the outer surface of an outer frame comprising the outer sealing body 936. The tip 940 of the arm 933 is positioned radially inward of the outer sealing body 936, unlike the anchors 932.

[0609] FIG. 104 illustrates flat or plan view of the inner frame 938. The arm 933 is shown to have a length that is less than the length of the strut arms 942 and accordingly less than the anchors 932. The arm 933 may comprise a shortened strut arm of the strut arms 942 and comprises a truncation of the length of the strut arms 942.

[0610] FIG. 105 illustrates a close-up view of the arm 933. Struts adjacent to the arm 933 may have their configuration modified to account for the loading conditions present due to the arm 933.The struts 935a, for example, may have an increased length relative to other adjacent struts. The struts 935b may have an increased width and decreased length in some implementations. The struts 935c may have an increased width. The struts 935d may have a decreased width. Other variations in the configuration of the struts may be provided in some implementations.

[0611] In some implementations, the arm 933 may serve to provide material at the position at which an anchor would be present if the plurality of anchors were uniformly distributed about the outer circumference of the treatment device 930. Such a feature may provide for more symmetric crimping and loading of the treatment device 930 during a crimping or loading procedure. The presence of the arm 933 may serve to more evenly distribute the material of the frame during a crimping or loading procedure, thus reducing the possibility of poor crimp symmetry of the treatment device 930. Such features may be utilized with an alignment body as disclosed in FIGS. 96-100 or with any other feature disclosed herein. The features of the treatment device 930 may be utilized with any other example disclosed herein. The treatment device 930 may utilize any other feature of another treatment device (e.g., prosthetic valve, implant, etc.) disclosed herein.

[0612] FIG. 106 illustrates a configuration of a treatment device, depicted for illustrative purposes as a prosthetic valve 950, that may be utilized in some implementations herein. The prosthetic valve 950 may include the features of any other prosthetic valve disclosed herein, including an outer sealing body 952. The prosthetic valve 950 may include an outer frame and an inner frame as disclosed herein.

[0613] The prosthetic valve 950 may include a plurality of ventricular anchors 954 that may each be configured similarly. The ventricular anchors 954 may be configured similarly as other forms of ventricular anchors disclosed herein, such as the ventricular anchors 640 discussed in regard to FIG. 65. The ventricular anchors 954 may be positioned in an orientation as discussed in regal’d to FIG. 78. At the section 956 of the prosthetic valve 950 that corresponds to the section 750 in FIG. 78, an anchor 958 that differs structurally from the remaining anchors 954 may be positioned.

[0614] The anchor 958 may differ in a variety of manners. For example, as shown in FIG. 106, the anchor 958 may be flattened and pressed against the outer surface 960 of the outer sealing body 952 such that the anchor 958 is flush with the outer surface 960. As such, a reduced possibility of adverse effects due to the presence of the anchor 958 may result. FIG. 107 illustratesa cross-sectional schematic view showing the relative position of the anchor 958. The drop loop 962 of the anchor may have a smaller radius of curvature than the remaining anchors 954 to press the anchor 958 closely to the outer surface 960. The anchor 958 may nest within the outer surface 960 in some implementations.

[0615] In some implementations, the anchor 958 may be less stiff than the other anchors 954 (e.g., with a variation in cut design of the anchor 958, among other methods). The anchors 958 may be a soft anchor that provides structure to provide stability support but is not stiff enough to push against a ventricular wall with force. In some implementations, the anchor 958 may be constructed purely of a soft flexible material, such as silicone and / or padding. Other variation in the construction of the anchor 958 may be provided in some implementations.

[0616] The anchor 958 may be constructed to provide material that improves symmetric crimping or loading of the prosthetic valve 950, and / or may be constructed to reduce a force applied by the anchor 958 to adjacent tissues upon deployment. The features of the prosthetic valve 950 may be utilized with any other example disclosed herein. The prosthetic valve 950 may utilize any other feature of a prosthetic valve disclosed herein.

[0617] FIGS. 108A-D illustrate a configuration of an insertion assembly that may be utilized with examples herein. FIGS. 108A and 108B, for example, illustrate an introducer 800 and sheath 802 that may be utilized for insertion into a patient’s vasculature (e.g., percutaneous and / or transvenous insertion). The introducer 800 may be positioned within the sheath 802 upon insertion, and then withdrawn to provide an insertion lumen within the sheath 802. Prior to insertion of the introducer 800 and sheath 802, one or more dilators 804 (shown in FIG. 108C) may be utilized to dilate the vasculature for entry.

[0618] FIG. I08D illustrates a loader that may be utilized to load the elongate shaft assembly of the delivery system into the sheath 802.

[0619] FIGS. 109A-109C illustrate an exemplary insertion sequence into the sheath 802. In FIG. 109A, the nose body 142 may be inserted into the loader 806 and may pass through a lumen of the loader 806. Referring to FIG. 109B, the elongate shaft assembly 12 positioned within the loader 806 may be inserted along with the loader 806 into the lumen of the sheath 802. Referring to FIG. 109C, the loader 806 may remain in place upon passage of the elongate shaft assembly 12 through the vasculature to a deployment site.

[0620] Notably, the sheath 802 may be inserted prior to the insertion of the elongate shaft assembly 12. The dome shape of the nose body 142 may improve passage through the sheath 802 (from the proximal end portion of the sheath 802 to the distal end portion of the sheath 802) and into the patient’s vasculature.

[0621] FIG. 110 illustrates an example of a clamp 810 that may be utilized to secure the delivery system 10. The clamp 810 may secure to a stabilization point 812 (marked in FIG. 18) of the handle 14. The clamp 810 may be secured to a rail 814 as shown in FIG. 111. The rail 814 may engage with a stabilizer table 816 as shown in FIG. 112. Other forms of stabilization may be utilized in some implementations. The features of FIGS. 108A-112 may be varied in some implementations. The features of the systems / devices in FIGS. 108A-1 12 may be utilized with any implementation herein.

[0622] FIG. 113 illustrates a configuration of a treatment device (e.g., replacement device, repair device, implant, etc.), depicted for illustrative purposes as a prosthetic valve 1000, that may be utilized in some implementations herein. The prosthetic valve 1000 may include the features of any other treatment device (e.g., prosthetic valve, repair device, implant, etc.) disclosed herein, including an outer sealing body 1002. The prosthetic valve 1000 may include a frame as disclosed herein. The frame may include an outer frame and an inner frame as disclosed herein.

[0623] In some implementations, the prosthetic valve 1000 may include a plurality of anchors 1004. Each of the plurality of anchors 1004 may be configured to extend around a native leaflet of a native heart valve.

[0624] In some implementations, one, some, or all of anchors 1004 may have a hook shape, and may be adapted to hook over a native heart valve leaflet for anchoring.

[0625] In some implementations, one, some, or all of anchors 1004 may have a shape of an elongate arm in some implementations.

[0626] In some implementations, one, some, or all of anchors 1004 may include a connecting portion 1006 (marked in FIGS. 113 and 114) that connects the respective anchor 1004 to the frame 1008 (marked schematically in dot-dash lines in FIG. 114). The connecting portion 1006 may comprise a proximal portion of the respective anchor 1004 at which the anchor 1004 connects to the frame 1008. In some implementations, the connecting portion 1006 may connect to an innerframe of the frame 1008 (as represented in FIG. 66 for example) or may connect to an outer frame of the frame 1008 or other portion of the frame 1008 as desired.

[0627] In some implementations, one, some, or all of anchors 1004 may extend from the connecting portion 1006 to a respective tip 1010 of the anchor 1004. One, some, or all of anchors 1004 may extend proximally from the connecting portion 1006 to the respective tip 1010. One, some, or all of anchors 1004 may extend radially outward from the connecting portion 1006 to the respective tip 1010. In some implementations, one, some, or all of anchors 1004 may be spaced circumferentially from a circumferentially adjacent one of the plurality of anchors 1004.

[0628] In some implementations, at least one of the anchors 1004 may be shaped such that the tip 1010 of the anchor 1004 is angled relative to the connecting portion 1006 circumferentially towards a circumferentially adjacent anchor of the plurality of anchors 1004. For example, an anchor 1004a is identified in FIG. 113. The anchor 1004a is shaped such that the tip 1010 of the anchor 1004a is angled relative to the connecting portion 1006 of the anchor 1004a circumferentially towards a circumferentially adjacent anchor (e.g., anchor 1004b).

[0629] FIG. 114 illustrates a side schematic view of anchors 1004 relative to the frame 1008 for the prosthetic valve 1000. With reference to the anchor 1004a, the aim 1012a of the anchor 1004a is shown to extend proximally from the connecting portion 1006, angled towards the adjacent anchor 1004b. The angle 1014a of the arm 1012a may be relative to a longitudinal axis 1016a that extends parallel with a central axis 1018 (marked in FIGS. 113 and 115) of the prosthetic valve 1000 that passes longitudinally through the flow channel of the prosthetic valve 1000. The angle 1014a may be offset from the longitudinal axis 1016a such that the tip 1010 is deflected towards the adjacent anchor 1004b. In some implementations, the tip 1010 may converge towards the tip 1010b of the adjacent anchor 1004b. In some implementations, the tip 1010 may be positioned circumferentially closer to the adjacent tip 1010b than the positions of the respective connecting portions 1006, 1006b of the anchors 1004a, 1004b to each other in some implementations .

[0630] In some implementations, the arm 1012a may have a straight or linear shape between the connecting portion 1006 and the tip 1010, or may have curved or arcuate shapes (among other shapes) as desired.

[0631] The plurality of anchors 1004 may include an anchor 1004c shaped such that the tip 1010c of the anchor 1004c is angled relative to the connecting portion 1006c of the anchor 1004c circumferentially towards the anchor 1004a. The anchor 1004c may be angled towards the anchor 1004a at a circumferential direction that is opposite the circumferential direction that the anchor 1004a is angled. As such, referring to FIG. 114, the tips 1010, 1010c of the respective anchors 1004a, c converge towards each other. The angle 1014c of the arm 1012c of the anchor 1004c may be relative to a longitudinal axis 1016c that extends parallel with the central axis 1018 of the prosthetic valve 1000. The angle 1014c may be offset from the longitudinal axis 1016c such that the tip 1010c is deflected towards the anchor 1004a.

[0632] In some implementations, a third anchor 1004b may be utilized. The third anchor 1004b may be positioned circumferentially between the anchors 1004a, c as represented in FIG. 114. In some implementations, the third anchor 1004b may lack an angulation with respect to the longitudinal axis 1016b that extends parallel with the central axis 1018 of the prosthetic valve 1000. The third anchor 1004b may extend proximally, from the connecting portion 1006b of the third anchor 1004b to the tip 1010b of the third anchor 1004b in a direction substantially parallel with the flow channel within the interior of the frame 1008. The first anchor 1004a and the second anchor 1004c may circumferentially converge towards the third anchor 1004b. The tips 1010, 1010c, 1010b of the respective first, second, and third anchors 1004a, 1004c, 1004b may converge together. In some implementations, the third anchor 1010b may have a deflection as desired.

[0633] The angle of one or more tips 1010, 1010c, 1010b of the anchors 1004a, 1004c, 1004b may produce a concentrated retention force upon a surface of a native valve leaflet 1020 (marked schematically in FIG. 114) to which the prosthetic valve 1000 is anchored to. Such a feature may reduce the overall circumferential area upon which the anchoring to the native valve leaflets occurs, and may produce sections 1022 of the outer circumference of the sealing body 1002 that lack an anchor tip. As such, for such sections 1022, a reduced possibility of adverse effects (as discussed herein) due to the presence of the tips of the anchors 1004 may result. Further, the concentration of force provided by the position of the tips of the anchors 1004 may be sufficient to properly retain and anchor to the native valve leaflets. Other beneficial results may be produced.

[0634] In some implementations, groups of anchors 1004 may be utilized, with each group being spaced circumferentially from each other about the prosthetic valve 1000. For example,each group may include at least one of the plurality of anchors 1004 being shaped such that the tip of the anchor 1004 is angled relative to the connecting portion of the anchor 1004 circumferentially towards a circumferentially adjacent anchor of the plurality of anchors 1004. A configuration as shown in FIG. 114 may be repeated circumferentially about the outer circumference of the prosthetic valve 1000, or other configurations of groups may be utilized as desired. A group 1024a (including the anchors 1004a, 1004c, 1004b) may be repeated as group 1024b and as group 1024c as represented in FIG. 115. Each group 1024a, b, c may be spaced equally circumferentially about the prosthetic valve 1000 or other spacing may be utilized as desired. Each group 1024a, b, c may include the three anchors 1004a, 1004c, 1004b, or a greater or lesser number of anchors as desired. At least three of the groups 1024a, b, c may be utilized as represented in FIG. 115, or a greater or lesser number may be utilized as desired.

[0635] For example, in a tricuspid implementation, it may be beneficial to include three groups 1024a, b, c of anchors, with each group configured to anchor to a respective native valve leaflet. Nine anchors may be utilized, or a greater or lesser number may be utilized. In a mitral implementation, it may be beneficial to include two groups of the anchors, with each group configured to anchor to a respective native valve leaflet. A greater or lesser number of groups may be utilized as desired. Combinations of anchors having angles as discussed herein and anchors lacking an angle may be utilized.

[0636] In some implementations, one or more of the anchors 1004a, 1004c, 1004b may be configured to clamp a native valve leaflet (e.g., leaflet 1020) towards an outer surface of the frame 1008. One or more of the anchors 1004a, c, b, for example, may be configured to be biased towards the outer surface of the frame 1008 such that a clamp of the native valve leaflet results. FIG. 118, for example, illustrates a relative position of an anchor 1004a towards the sealing body 1002. The tip 1010 of the anchor 1004a may press the leaflet 1020 towards the sealing body 1002. Each of the tips 1010, 1010b, 1010c of the group 1024a may press the leaflet 1020 towards the sealing body 1002. Each of the groups 1024b, c may press a leaflet towards the sealing body 1002.

[0637] In some implementations, the tip of at least one of the anchors 1004 may comprise a paddle. The paddle, for example, may comprise a flattened tip of the anchor 1004 that may be wider in diameter than the respective connecting arm of the anchor 1004. FIG. 116, for example, illustrates a schematic view of the tip 1010 of the anchor 1004a. The tip 1010 has a greaterdiameter than the arm 1012a of the anchor 1004. The width of the tip 1010 may be configured to distribute the force applied by the anchor 1004a to a wider area than would be provided with a narrower width of tip 1010. The tip 1010 may be compliant in some implementations, and may have flexibility to reduce the possibility of penetration or puncturing of the native valve leaflet.

[0638] In some implementations, the tip 1010 may include a loop of a base material 1030 that may define a perimeter of the tip 1010. The base material 1030 may be covered with a covering material 1032 that may cover an interior of the loop. The covering material 1032 may comprise a fabric or a padding or other material for spanning the interior of the loop. The covering material 1032 may provide a cushion for the anchor 1004a upon the native leaflet. In some implementations, the base material 1030 may form the arms 1012a of the anchor 1004a and may extend to and couple with the frame 1008 in some implementations. Other configurations may be utilized in some implementations. For example, a continuous strut arm may form the arm 1012a in some implementations, with a paddle coupled thereto, among other configurations.

[0639] One, some, or all of the anchors may include a tip having a paddle in some implementations .

[0640] In some implementations, the anchors (e.g., anchors 1004a, c) have an angle as represented in FIGS. 113-115. However, the anchors (e.g., anchors 1004a, c) may lack an angle and may extend linearly in a compressed, or undeployed, or linearized configuration as represented in FIG. 117. The prosthetic valve 1000 may be retained by a delivery system in a configuration as shown in FIG. 117. Upon deployment, the anchors (e.g., anchors 1004a, c) may form the angle upon being deployed at the implantation site. The features of the prosthetic valve 1000 may be utilized with any other example disclosed herein. The prosthetic valve 1000 may utilize any other feature of a prosthetic valve disclosed herein.

[0641] Features as disclosed in regard to FIGS. 113-118 may be utilized solely or in combination with any other example disclosed herein.

[0642] FIG. 119 illustrates an implementation in a configuration of a treatment device, depicted for illustrative purposes as a prosthetic valve 1040, that may be utilized in some implementations herein. The prosthetic valve 1040 may include the features of any other treatment device (e.g., prosthetic valve) disclosed herein, including an outer sealing body 1042. The prosthetic valve 1040 may include an outer frame and an inner frame as disclosed herein.

[0643] The prosthetic valve 1040 may include anchors 1044 that may be configured similarly as other forms of anchors disclosed herein, such as the ventricular anchors 640 discussed in regard to FIG. 65. In some implementations, one, some, or all of anchors may be adapted to extend around a native leaflet of a native heart valve. One, some, or all of the anchors of the prosthetic valve 1040 may be spaced circumferentially from a circumferentially adjacent one of the anchors.

[0644] In some implementations, the prosthetic valve 1040 may include an anchor 1046a that is angled in a circumferential direction away from a circumferentially adjacent anchor 1046b such that a size of a circumferential gap 1048 between the anchors 1046a, b is larger than a size of a circumferential gap 1050 between two other anchors 1044. A schematic view of the positions of the tips of the anchors relative to the outer sealing body 1042 is illustrated in FIG. 119, yet a top view of an inner frame 1052 including the anchors is illustrated in FIG. 120. FIG. 121 illustrates a perspective view of the inner frame 1052 and anchors.

[0645] Referring to FIG. 120, the anchors each include a connecting portion 1051 or proximal portion that couples to the inner frame 1052 and extends radially outward to a tip 1053 of the anchor. Each of the anchors 1044 (e.g., other than the anchors 1046a, b) are each illustrated extending radially outward from the inner frame 1052 at angles that are perpendicular or orthogonal with the inner frame 1052. The anchors 1046a, b, however, are each illustrated extending radially outward from the inner frame 1052 at angles that are non-perpendicular or non- orthogonal with the inner frame 1052. In some implementations, the anchor 1046a extends outward from the inner frame 1052 deflected in a circumferential direction away from the circumferentially adjacent anchor 1046b. In some implementations, the anchor 1046a is angled circumferentially towards an opposite circumferentially adjacent anchor 1044a. In some implementations, the arm of the anchor 1046a extends outward from the inner frame 1052 at the angle to the tip of the anchor 1046a. The deflection is a lateral deflection relative to the inner frame 1052.

[0646] In some implementations, the anchor 1046b extends outward from the inner frame 1052 deflected in a circumferential direction away from the circumferentially adjacent anchor 1046a. In some implementations, the arm of the anchor 1046b extends outward from the inner frame 1052 at the angle to the tip of the anchor 1046b. In some implementations, the deflection is a lateral deflection relative to the inner frame 1052. The anchor 1046b is angled circumferentially towardsan opposite circumferentially adjacent anchor 1044b. The size of the circumferential gap 1048 is larger than the size of the circumferential gap 1050. The increased size of the gap 1048 may be produced by both anchors 1046a, b being non-orthogonal and deflected away from each other, or in some implementations, a single one of the anchors (e.g., anchor 1046a) may be deflected circumferentially to produce the increased size of the gap 1048.

[0647] In some implementations, one, some, or all of the anchors may extend from a respective connecting portion to a tip of the anchor, parallel with respect to a respective longitudinal axis of the anchor that extends parallel with a central axis of the prosthetic valve (similar to the central axis 1018 of the prosthetic valve 1000). In some implementations, any of the anchors may have an angulation with respect to the central axis of the prosthetic valve as desired.

[0648] In some implementations, the anchor 1046a is angled in a circumferential direction towards the circumferentially adjacent anchor 1044a such that a size of the circumferential gap 1055 between the anchors 1044a, 1046a is smaller than the size of the gap 1048 between the anchors 1046a, b (and the size of the gap 1050 between the anchors 1044). Similarly, the anchor 1046b may be angled in a circumferential direction towards the circumferentially adjacent anchor 1044b such that a size of the circumferential gap 1054 between the anchors 1044b, 1046b is smaller than the size of the gap 1048 between the anchors 1046a, b (and the size of the gap 1050 between the anchors 1044).

[0649] The increased size of the circumferential gap 1048 may allow for a reduced possibility of adverse effects (as disclosed herein) due to the presence of the anchors at the gap 1048 or section of the outer circumference of the prosthetic valve 1040. Beneficially, however, the prosthetic valve 1040 may include anchor material at each of the spaced anchor locations, which may improve balance and material distribution upon a crimping and / or loading procedure for the prosthetic valve 1040. In some implementations, the anchors 1046a, b, for example, may be compressed into a linearized configuration upon crimping and loading, and may be equally spaced or at a non-angled configuration, and may then deploy at the angled configuration represented in FIG. 120 to produce the relatively wide gap 1048. The anchors may be made of a shape memory material (e.g., Nitinol) and configured to expand to the angled configuration. In some implementations, nine total anchors may be utilized, which may be connected to the frame 1052 at equal spacing, or other configurations or number of anchors may be utilized as desired.

[0650] The presence of the closely spaced anchors (e.g., anchors 1046b, 1044b) may provide increased stability adjacent to the position of the relatively wide circumferential gap 1048. The closely spaced anchors 1046a, 1044a may provide a similar function.

[0651] In some implementations, the gap 1048 may be positioned to account for a portion of the heart or heart valve annulus that preferably lacks the presence of one of the anchors, as disclosed herein.

[0652] An outer frame as disclosed herein may be implemented with the inner frame 1052 illustrated in FIGS. 120 and 121. The tips of the anchors may be positioned radially outward of the outer frame as disclosed herein, or other configurations may be utilized.

[0653] In some implementations, the anchors represented in FIGS. 119-121 may be connected to an outer frame and may extend outward from the outer frame at the angles disclosed herein. Other configurations may be utilized as desired.

[0654] The features of the prosthetic valve 1040 may be utilized with any other example disclosed herein. The prosthetic valve 1040 may utilize any other feature of a prosthetic valve disclosed herein.

[0655] Features as disclosed in regard to FIGS. 119-121 may be utilized solely or in combination with any other example disclosed herein.

[0656] FIG. 122 illustrates a configuration of a treatment device, depicted for illustrative purposes as a prosthetic valve 1070, that may be utilized in some implementations herein. The prosthetic valve 1070 may include the features of any other treatment device (e.g., prosthetic valve) disclosed herein, including an outer sealing body 1071. The prosthetic valve 1070 may include a frame 1064 as disclosed herein. The frame 1064 may include an outer frame 1073 and an inner frame 1075 as disclosed herein.

[0657] In some implementations, the prosthetic valve 1070 may include a telescoping mechanism or telescoping section 1060 for at least one of the anchors 1062 of the prosthetic valve 1070. The telescoping section 1060 may be configured to allow an axial position of at least one of the anchors 1062 to be adjusted relative to an axial position of the frame 1064 of the prosthetic valve in vivo.

[0658] In some implementations, the telescoping mechanism or telescoping section 1060, for example, may include a plurality of sheaths 1066a, b that may be configured to be extended longitudinally to vary the axial position of the anchor 1062 to which the telescoping section 1060 is coupled. The sheaths 1066a, b may be concentrically arranged, with the sheath 1066b comprising an inner sheath positioned radially inward of an outer sheath 1066a. An arm of the anchor 1062 may be positioned within the inner sheath 1066b. The telescoping section 1060 may couple the anchor 1062 to the frame 1064. Other configurations may be utilized as desired.

[0659] One, some, or all of the plurality of anchors 1062 may be configured to extend around a native leaflet of a native heart valve. One, some, or all of anchors 1062 may have a hook shape, and may be adapted to hook over a native valve leaflet for anchoring. One, some, or all of anchors 1062 may be made of a shape memory material (e.g., Nitinol) and configured to deflect to the hook shape. One, some, or all of anchors 1062 may have a shape of an elongate arm in some implementations. One, some, or all of anchors 1062 may be circumferentially spaced from each other, in a similar configuration as with the ventricular anchors 640 discussed in regard to FIG. 65.

[0660] In some implementations, the telescoping mechanism or telescoping section 1060 may be extended via a control assembly 1068 pressing distally to extend the telescoping section 1060. The control assembly 1068 may be configured to control the axial position of the telescoping section 1060. The control assembly 1068 as represented in FIGS. 123 and 124, for example, may comprise a pusher shaft or other form of device for applying a distal motion to the telescoping section 1060 for the axial extension of the telescoping section 1060 to occur. The control assembly 1068 may extend along a delivery system or may be a part of a delivery system in some implementations. Other mechanisms for extending the telescoping section 1060 may be utilized in some implementations.

[0661] The telescoping mechanism or telescoping section 1060 may be operated in vivo. As such, the telescoping section 1060 may be operated when the prosthetic valve 1070 is in a linearized configuration, for example, retained within a capsule 1072 or other form of retention device for compressing or linearizing the prosthetic valve 1070. The prosthetic valve 1070 may be retained by a delivery system as disclosed herein for example. The telescoping section 1060 may be configured to allow the axial position of an anchor 1062 to be adjusted relative to the axial position of the frame 1064 with the anchors 1062 in a linearized configuration.

[0662] In some implementations, a plurality of the telescoping mechanisms or telescoping sections 1060 may be utilized, each coupled to a respective one of the anchors 1062. Each telescoping section may be configured to allow an axial position of a respective one of the plurality of anchors 1062 to be adjusted relative to the axial position of the frame 1064 in vivo. One, some, or all of anchors 1062 may individually have the axial position of such anchor 1062 adjusted as desired in vivo.

[0663] In some implementations, the telescoping section 1060 may be utilized to vary the axial position of the anchor 1062 at a portion of the prosthetic valve 1070 at which it is desired to adjust an anchor tip 1077 position of the anchor 1062. Beneficially, such a feature may be utilized to move the position of the anchor tip 1077 at a portion of the heart or heart valve annulus that preferably lacks the presence of one of the anchors as disclosed herein. For example, the position of the prosthetic valve 1070 may be imaged or visualized at or prior to deployment to determine which anchor 1062 or anchors 1062 of the prosthetic valve 1070 should have an axial position adjusted. In some implementations, a corresponding control assembly 1068 may be operated to adjust the axial position of the desired anchor 1062 or anchors 1062. The axial positions of one or more of the anchors 1062 may be adjusted. The remaining anchors 1062 may or may not be adjusted as desired. In some implementations, nine total anchors may initially be utilized, with one having its axial position varied and eight having their axial positions non-varied. Other configurations (e.g., varying two or three of the anchors) may be utilized, and the initial number of anchors may be varied as desired.

[0664] FIG. 125, for example, illustrates a resulting configuration. The telescoping section 1060 for the anchor 1062 has been extended to adjust the axial position of the anchor 1062. The anchor 1062 may be positioned more distal, or ventricular, than other anchors of the prosthetic valve. The tip 1077 of the anchor 1062 has been moved distal or ventricular of the heart valve annulus (with prosthetic valve leaflets 1069 shown). As such, reduced possibility of interference with the native heart valve or native heart valve annulus may result. The extended anchor 1062 retains its hook shape when the anchor 1062 is in the longitudinally extended configuration as represented in FIG. 125. The telescoping section 1060 allows the anchor 1062 to be in a longitudinally extended configuration while at least one other anchor (e.g., anchor 1062a marked in FIG. 125) extends around a native valve leaflet 1069 of the native heart valve for anchoring. A telescoping section (e.g., telescoping section 1060a marked in FIG. 125) may have sufficientretention force (e.g., via friction or another form of force) to retain the position of the remaining non-cxtcndcd anchors (e.g., anchor 1062a).

[0665] In some implementations, the telescoping section 1060 may allow the anchor 1062 to be retracted proximally (or in an atrial direction) to adjust the axial position of the anchor 1062. The proximal or atrial retraction may similarly exclude the anchor 1062 from potentially interfering with the native heart valve or native heart valve annulus. The control assembly 1068 may be varied to allow for a retraction (e.g., via a suture loop or another mechanism) of the telescoping section 1060. The tip 1077 of the anchor 1062 may similarly be moved away (e.g., proximal or atrial) from the native heart valve or native heart valve annulus.

[0666] The features of the prosthetic valve 1070 may be utilized with any other example disclosed herein. The prosthetic valve 1070 may utilize any other feature of a prosthetic valve disclosed herein.

[0667] Features as disclosed in regard to FIGS. 122-125 may be utilized solely or in combination with any other example disclosed herein.

[0668] Variations in the configuration of the prosthetic valve 1070 may be provided in some implementations. FIG. 126, for example, illustrates a configuration of a treatment device, depicted for illustrative purposes as a prosthetic valve 1079, that may be utilized in some implementations herein. The prosthetic valve 1079 may include the features of any other treatment device (e.g., prosthetic valve) disclosed herein, including an outer sealing body 1081. The prosthetic valve 1079 may include a frame 1084 as disclosed herein. The frame 1084 may include an outer frame 1085 and an inner frame 1087 as disclosed herein.

[0669] FIG. 126 illustrates an implementation of a prosthetic valve in which a release mechanism and / or release control 1080 is configured to allow at least one of the plurality of anchors 1082 to release from the frame 1084 and be removed from the frame 1084 in vivo.

[0670] In some implementations, one, some, or all of the plurality of anchors 1082 may be configured to extend around a native leaflet of a native heart valve. In some implementations, one, some, or all of anchors 1082 may have a hook shape, and may be adapted to hook over a native valve leaflet for anchoring. In some implementations, one, some, or all of anchors 1082 may be made of a shape memory material (e.g., Nitinol) and configured to deflect to the hook shape. Insome implementations, one, some, or all of anchors 1082 may have a shape of an elongate arm in some implementations. In some implementations, one, some, or all of anchors 1082 may be circumferentially spaced from each other, in a similar configuration as with the ventricular anchors 640 discussed in regard to FIG. 65.

[0671] The release mechanism or release control 1080 may have a variety of forms, which may allow the release control 1080 to release from the frame 1084. The release control 1080 may couple an anchor 1082 to the frame 1084. The release control 1080 may couple the anchor 1082 to the inner frame 1087, or to the outer frame 1085 in some implementations. In some implementations, the release control 1080 may include a releasable joint 1086 (marked in FIG. 127) that may couple the anchor 1082 to the frame 1084 and may release the anchor 1082 from the frame 1084.

[0672] The release control 1080 may be positioned such as to allow the prosthetic heart valve leaflets 1083 to remain coupled to the frame 1084 upon release of a release control 1080.

[0673] The releasable joint 1086 may be configured to be rotated about an axial dimension of the anchor 1082 to release the anchor 1082 from the frame 1084. For example, the releasable joint 1086 may have axial strength and may resist an axial force, yet may be releasable upon a rotational force being applied to the releasable joint 1086. The releasable joint 1086 may be frangible upon the rotational force being applied to the joint 1086. For example, a circumferentially narrow connection between axially extending bodies 1088a, b (illustrated in FIG. 127, for example) may be broken upon one of the bodies 1088a, b rotating axially relative to the other body. FIG. 128A, for example, represents an axial rotation of the body 1088a, resulting in the separation of the bodies 1088a, b in FIG. 128B.

[0674] In some implementations, the release control 1080 may include an engagement feature 1090 for engagement with a control assembly for applying the rotational force to the releasable joint 1086. In some implementations, the engagement feature 1090 may comprise a keyed feature, such as an elongate slot, for receiving a corresponding device 1092 of the control assembly (e.g., a flattened head as illustrated in FIG. 129). The device 1092 (e.g., a flattened head) may engage with the engagement feature 1090 and may rotate the body 1088a to release the releasable joint 1086. In some implementations, other forms of engagement features may be utilized (e.g., mating protrusions, or hex configurations, as desired). The engagement features may be separable to allowthe device 1092 to retract from the engagement feature 1090 following deployment. Other forms of control assemblies may be utilized in some implementations.

[0675] In some implementations, the control assembly may include a retention feature 1094 that may be utilized to retain a released anchor 1082 following operation of the release control 1080. The retention feature 1094, for example, may comprise a tether (e.g., a suture or other form of tether) that may couple to the anchor 1082 (e.g., via passage through an opening 1096 or another form of coupling). The retention feature 1094 may retain and withdraw the released anchor 1082 following operation of the release control 1080.

[0676] In some implementations, and as illustrated in FIG. 129, a plurality of the retention features 1094 may be utilized, each coupled to a respective one of the anchors 1082. Similarly, a plurality of the devices 1092 (e.g., a flattened head) may be utilized. If one of the anchors 1082 is not to be removed, then the retention feature 1094 (as shown in FIG. 130) may be released from that anchor 1082 to allow the retention feature 1094 to disengage from the prosthetic valve 1079. The retention feature 1094 that remains coupled to the released anchor 1082 may be pulled to remove the released anchor 1082. In some implementations, the control assembly may extend along a delivery system or may be a part of a delivery system.

[0677] A plurality of the release mechanisms or release controls 1080 may be utilized, each corresponding to one of the anchors 1082. In some implementations, each release control 1080 may couple one of the anchors 1082 to the frame 1084 and is configured to allow the respective anchor 1082 to release from the frame 1084 and be removed from the frame 1084. As such, a user may determine which of the anchors 1082 should be removed and may remove such an anchor 1082. The removal may occur in vivo. For example, the removal may occur with the prosthetic valve positioned within a capsule 1098 or other form of retention body and in a linearized or compressed configuration. A release control may allow one or more of the anchors to release from the frame 1084 and be removed from the frame 1084 in a linearized configuration. Imaging may occur at or prior to deployment to determine which anchor 1082 should be released and removed. A corresponding release control 1080 may be operated to release and remove the anchor 1082. One or more of the anchors 1082 may be released and removed. The remaining anchors 1082 may not be released and removed as desired.

[0678] FIG. 131 , for example, illustrates a resulting configuration in which a release control 1080 has been operated to remove one of the anchors 1082. Another of the anchors (c.g., anchor 1082a) may remain in position. As such, reduced possibility of interference with the native heart valve or native heart valve annulus may result as disclosed herein. Other anchors may remain for anchoring to the native heart valve. In some implementations, nine total anchors may initially be utilized, with one removed to leave eight total anchors. Other configurations (e.g., removing two or three of the anchors) may be utilized, and the initial number of anchors may be varied as desired.

[0679] The features of the prosthetic valve 1079 may be utilized with any other example disclosed herein. The prosthetic valve 1079 may utilize any other feature of a prosthetic valve disclosed herein.

[0680] Features as disclosed in regard to FIGS. 126-131 may be utilized solely or in combination with any other example disclosed herein.

[0681] In some implementations, it may be desirable to rotate the treatment device (e.g., prosthetic valve) about the longitudinal axis 9 (marked in FIG. 1) of the elongate shaft assembly (e.g., the elongate shaft assembly 12). Implementations may include a rotation control that may be configured to rotate the treatment device about the longitudinal axis of the elongate shaft assembly.

[0682] FIG. 132, for example, illustrates a configuration of a rotation control and / or rotation mechanism 1100 that may be utilized in some implementations herein. In some implementations, the rotation control 1100 may include a pivot joint 1102 positioned at a distal end portion of the elongate shaft assembly of the delivery system for producing a rotation of the treatment device about the longitudinal axis of the elongate shaft assembly. For example, the pivot joint 1102 may be positioned at a distal end portion of an intermediate shaft or mid shaft assembly 1104 (which may otherwise correspond to the intermediate shaft or mid shaft assembly 21). The pivot joint 1102 may be positioned in other locations in some implementations, for example, at a distal end portion of another shaft of an elongate shaft assembly or at another portion of a delivery system.

[0683] In some implementations, the pivot joint 1102 may be actuatable by a user to produce a rotation of the treatment device. The pivot joint 1102, for example, may include a ratcheting body 1107 (marked in FIG. 135) that may be configured to rotate in a direction. The ratcheting body 1107 may include a first ratcheting surface 1106 (marked in FIG. 135) that may be configuredto rotate upon engaging with a second ratcheting surface 1108 (marked in FIGS. 134 and 137). The second ratcheting surface 1108 may be positioned on an axially movable body 1117.

[0684] In some implementations, the ratcheting body 1107 may be a rotational body that may couple to a portion of the intermediate shaft or mid shaft assembly 1104 to rotate the corresponding portion of the intermediate shaft or mid shaft assembly 1104. For example, the ratcheting body1107 may be coupled to the outer retention member or ring 1110 (e.g., at an outer perimeter of the ratcheting body 1107) and rotation of the ratcheting body 1107 may produce the corresponding rotation of the outer retention member or ring 1110.

[0685] In some implementations, the first ratcheting surface 1106 may be configured to engage with the second ratcheting surface 1108 upon an axial movement of the second ratcheting surface1108 relative to the first ratcheting surface 1106. In some implementations, the second ratcheting surface 1108 may advance distally to engage with the first ratcheting surface 1106. In some implementations, the first and second ratcheting surfaces 1106, 1108 may include angled teeth, which may produce a rotation in a direction due to the angle of the teeth. The plurality of angled teeth may be configured to engage to produce a rotation of the treatment device about the longitudinal axis of the elongate shaft in a single rotational direction. The first ratcheting surface 1106 may include a first set of the angled teeth that are axially displaceable relative to the second ratcheting surface 1108 having a second set of angled teeth. In some implementations, a stop surface 1112 (marked in FIG. 136) on the outer retention member or ring 11 10 may impede further axial movement of the second ratcheting surface 1108.

[0686] Upon axial retraction (or proximal movement) of the second ratcheting surface 1108, a biasing body or spring 1114 may maintain separation between the first ratcheting surface 1106 and the second ratcheting surface 1108.

[0687] In some implementations, a third ratcheting surface 1116 may be positioned on the ratcheting body 1107 and may face opposite the first ratcheting surface 1106. Similarly, a fourth ratcheting surface 1118 (marked in FIG. 134) may be positioned on the axially movable body 1117 for engaging with the third ratcheting surface 1116. The ratcheting surfaces 1116, 1118 may include respective sets of angled teeth that may continue the direction of rotation produced by the engagement of the first and second ratcheting surfaces 1106, 1108.

[0688] The axially moveable body 1 117 accordingly may move axially distal and proximal to produce a rotation of the ratcheting body 1107. The angles of the respective ratcheting surfaces may produce the rotation of the ratcheting body 1107 in a single rotational direction.

[0689] In some implementations, the axial movement of the axially movable body 1117 may be produced via longitudinal movement of a body extending along the elongate shaft assembly. In some implementations, the body may comprise the intermediate shaft or mid shaft assembly 1104 or another body as desired (e.g., a tether or another shaft, or another form of body). The body (e.g., an intermediate sheath or shaft 1120 that may correspond to the intermediate sheath or shaft 40) may be moved axially between advanced and retracted positions to produce the axial movement of the axially movable body 11 17. The body may utilize oscillatory motion to produce rotation of the pivot joint 1102 in a single rotational direction.

[0690] In some implementations, a distal end 1123 (marked in FIG. 136) of the flexible section or hypotube section 1122 (corresponding to the flexible section or hypotube section 44) may be able to rotate relative to the outer retention member or ring 1110 at a bearing surface 1124 (marked in FIG. 136). The axial advancement of the flexible section or hypotube section 1122 may axially press against the axially movable body 1117 to advance the body 1117 and cause the first and second ratcheting surfaces 1106, 1108 to engage (with FIG. 136 illustrating such a configuration). Retraction of the flexible section or hypotube section 1122 may reduce the force upon the axially movable body 1117 by the distal end 1123 of the flexible section or hypotube section 1122, thus allowing the spring 1114 to press the third and fourth ratcheting surfaces 1116, 1118 together (to continue the rotation of the outer retention member or ring 1110).

[0691] In some implementations, the longitudinal movement of the intermediate shaft or mid shaft assembly 1104 may be produced via a rotation of the actuator assembly 252 (marked in FIG. 138) for the intermediate shaft or mid shaft assembly. The actuator assembly 252 may produce the oscillatory motion of the body or intermediate shaft or mid shaft assembly 1104. The actuator assembly 252 may include a rotatable knob positioned on the handle for grip by a user. The rotation of the actuator assembly 252 (e.g. the rotatable knob) may be an oscillating or back-and- forth rotation to correspondingly move the intermediate shaft or mid shaft assembly 1104 longitudinally back-and-forth. Such movement results in the rotation of the ratcheting body 1107 and accordingly of the outer retention member or ring 1110.

[0692] In some implementations, a user may utilize the actuator assembly 252 to retract or advance the intermediate shaft or mid shaft assembly 1104 by not performing such oscillatory motion, but via continued rotation of the actuator assembly 252 in a direction which will produce the desired retraction or advancement of the intermediate shaft or mid shaft assembly 1104 (with minimal rotation of the outer retention member or ring 1110). As such, an actuator assembly 252 utilized for axial retraction or advancement of the outer retention member or ring 1110 may also be utilized to rotate the outer retention member or ring 1110 in a direction. The actuator assembly 252 is configured to retract the intermediate shaft or mid shaft assembly 1104 to release the treatment device from the treatment retention area.

[0693] In some implementations, the outer retention member or ring 1110 may sufficiently engage with the treatment device (e.g., via compressive friction) such that rotation of the outer retention member or ring 1110 produces rotation of the treatment device with the outer retention member or ring 1110 covering the treatment device. In some implementations, the rotation control 1100 is adapted to rotate the outer retention member or ring 1110 to produce a corresponding rotation of the treatment device about the longitudinal axis of the elongate shaft assembly. Similarly, rotation of an outer capsule (e.g., the capsule 38) may result from the rotation of the outer retention member or ring 1110 due to the frictional engagement between the outer sheath assembly 22 and the intermediate shaft or mid shaft assembly 1104. The rotation control 1100 accordingly may rotate the outer capsule.

[0694] In some implementations, the inner retention member 1128 may correspond to the inner retention member 50, yet may be pivotally coupled to the inner shaft 130. As such, the inner retention member 1128 may rotate with the treatment device about the longitudinal axis of the elongate shaft due to the rotation of the outer retention member or ring 1110.

[0695] The ratcheting body 1107 is illustrated as having ratcheting surfaces on both sides of the ratcheting body 1107. However, in some implementations, a single side of the ratcheting body 1107 may include a ratcheting surface, with the configuration of the ratcheting surfaces adjusted to avoid the ratcheting body 1107 from becoming stuck or stalled based on the relative axial movement of the axially movable body 1117.

[0696] FIGS. 139-142, for example, illustrate an exemplary variation that may be utilized, in which the ratcheting body 1130 or rotational body includes a ratcheting surface 1132 on a singleside of the ratcheting body 1 130. The axially movable body 1 134 includes a ratcheting surface 1136 on a side of the axially movable body 1134 facing the ratcheting surface 1132. A base 1138 may include a ratcheting surface 1140 that is offset in tooth configuration than the ratcheting surface 1136 of the axially movable body 1134. As such, the axial movement of the axially movable body 1134 may selectively engage the ratcheting body 1130 with either set of the ratcheting surfaces 1136, 1140, thus producing rotation of the ratcheting body 1130 in a direction.

[0697] In some implementations, an axially extending body (e.g., a tether) may be utilized to retract the axially movable body 1134. A spring 1142 may be utilized to press the axially movable body 1134 distal upon release of the retraction force of the axially extending body. In some implementations, an axially extending body may be utilized to drive the axially moveable body 1134 distal for engagement between the ratcheting surfaces 1132, 1136. The axially extending body may comprise a shaft (e.g., an intermediate shaft or mid shaft assembly 1104) as disclosed herein. The shaft may produce proximal and / or distal movement of the axially movable body 1134 in some implementations. In some implementations, the base 1138 may comprise a housing supporting the ratcheting body 1130, as represented in FIG. 142. The configuration as represented in FIGS. 139-142 may be utilized in a similar location as with the pivot joint 1102 indicated in FIG. 132. Other configurations may be utilized in some implementations.

[0698] FIGS. 143-145 illustrate an implementation in which the pivot joint includes a slotted cam body 1148 that is engaged with an axially protruding body 1149. The slotted cam body 1148 is configured to rotate to produce the rotation of the treatment device when the axially protruding body 1149 displaces axially relative to the slotted cam body 1148. The slotted cam body 1148 is configured to rotate relative to the protruding body 1149 due to an axial force being applied to the slotted cam body 1148 and / or protruding body 1149. The slotted cam body 1148, for example, may include a helical slot 1150 that may receive the protrusion 1152 of the protruding body 1149.

[0699] In some implementations, an axial movement of the slotted cam body 1148 relative to the protruding body 1149 produces a corresponding rotation of the slotted cam body 1148 due to the shape of the helical slot 1150. In some implementations, an axially extending body (e.g., a tether) may be utilized to retract the slotted cam body 1148. In some implementations, a spring 1154 may be utilized to press the slotted cam body 1148 distal upon release of the retraction force upon the slotted cam body 1148. In some implementations, an axially extending body may be- no -utilized to drive the slotted cam body 1148 distal for rotation of the cam body 1148 relative to the protruding body 1149. The axially extending body may comprise a shaft (e.g., an intermediate shaft or mid shaft assembly 1104) as disclosed herein. In some implementations, a force may be applied to the slotted cam body 1148, which may move relative to the static axially protruding body 1149. The configuration as represented in FIGS. 143-145 may be utilized in a similar location as with the pivot joint 1102 indicated in FIG. 132. Other configurations may be utilized in some implementations.

[0700] In some implementations, solely axial movement may be provided via an axial displacement mechanism as represented in FIGS. 146 and 147. An axially movable body 1160 may be configured to move axially relative to a base 1 162. A slot and pin configuration 1164 or other configuration may allow for the axial movement, yet may prevent rotational movement. An axially extending body (e.g., a tether) may be utilized to retract the axially movable body 1160. A spring 1166 may be utilized to press the axially movable body 1160 distal upon release of the retraction force of the axially extending body. The movement of the assembly as represented in FIGS. 146 and 147 may produce axial movement of the treatment device and / or of one or more of the retention members (e.g., a capsule, outer retention member, and / or inner retention member) of the elongate shaft assembly. In some implementations, an axially extending body may be utilized to drive the axially movable body 1160 distal for distal displacement of the axially movable body 1160 relative to the base 1162. Other configurations may be utilized in some implementations.

[0701] In some implementations, variations of the housing or handle 14 may be provided such that one or more portions of the housing or handle 14 rotate relative to each other to produce a corresponding rotation of the treatment device about the longitudinal axis of the elongate shaft. Referring to FIG. 148, rotational movement of the delivery housing 232 relative to the rail housing 230 may be impeded via protrusions (e.g., a protrusion 1170 of the brace 330, a protrusion 1172 of the adaptor 270, and / or a protrusion 1174 of the adaptor 274) that extend through a longitudinal slot 1176 in the delivery housing 232. The longitudinal slot 1176 may be for engagement between the delivery housing 232 and the rail housing 230. The circumferential width 1178 of the longitudinal slot 1176 may be set to match a width of the respective protrusions (e.g., protrusions 1170, 1172, 1174) such that rotation of the delivery housing 232 relative to the rail housing 230 is impeded.- Ill -

[0702] FIG. 149 illustrates an implementation in which the size of the circumferential width 1180 of the longitudinal slot 1176 has been increased to allow for rotation of the delivery housing 232 relative to the rail housing 230 about the longitudinal axis of the housings or handle. As such, a rotation control in the form of the longitudinal slot 1176 may be utilized to rotate the treatment device about the longitudinal axis of the elongate shaft assembly. FIG. 150 illustrates that the size of the circumferential width 1182 of the slot 1184 on the opposite side of the delivery housing 232 has also been increased to allow for corresponding rotation on the opposite side of the housing 232.

[0703] FIGS. 151 and 152 illustrate cross-sectional views of the corresponding rotation of the delivery housing 232 relative to the rail housing 230. The size of the circumferential widths 1 180, 1182 may be set as desired. For example, between a 20 degree and 90 degree width may be utilized (although greater or lesser angles may be utilized as desired). Between 30 degrees and 80 degrees may be utilized. In some implementations, between 40 degrees and 70 degrees may be utilized. In some implementations, between 40 degrees and 60 degrees may be utilized. In some implementations, about 45 degrees may be utilized. Other ranges may be utilized as desired.

[0704] The rotation of the delivery housing 232 relative to the rail housing 230 may rotate each assembly (aside from the rail shaft assembly 20) about the longitudinal axis of the elongate shaft. Accordingly, the treatment device may rotate about the longitudinal axis of the elongate shaft as desired. One or more of the retention members (e.g., a capsule, outer retention member, and / or inner retention member) of the elongate shaft assembly may rotate as well. In some implementations, the pull tether corresponding to the height actuation may be moved from the delivery housing 232 to the rail housing 230 to prevent possible actuation of the height pull tether upon rotation of the delivery housing 232 relative to the rail housing 230. In some implementations, a separate actuator assembly may be utilized on the rail housing 230 to actuate the height pull tether in such implementations, or other configurations may be utilized as desired.

[0705] In some implementations, portions of the delivery housing 232 may be configured to rotate relative to each other to produce a rotation of the treatment device about the longitudinal axis of the elongate shaft. In some implementations, a distal portion of the delivery housing 232 may be adapted to rotate relative to a portion of the delivery housing 232 that is positioned proximal of the distal portion (e.g., a central portion or proximal end portion) of the deliveryhousing 232 to produce a corresponding rotation of the treatment device. The portions of the delivery housing 232 that may rotate may include those portions engaged with the mid shaft assembly 21 and / or the outer shaft assembly 22, to produce a corresponding rotation of the treatment device. Other portions and / or shaft assemblies may rotate in other implementations as desired.

[0706] FIG. 153 illustrates a cross-sectional view of a distal portion of the delivery housing 232 with the rotatable knob of the mid shaft assembly actuator 252 excluded from view. The delivery housing 232 includes sections 1192, 1194 that house the respective actuator assemblies for the outer shaft assembly 22 and the mid shaft assembly 21. The adaptors 246, 256 for the respective assemblies are shown to extend within a guide channel 1 196 that extends distally from a fixed connection 1198 with the central portion 1211 of the delivery housing 232, through the section 1194, and through the section 1192. The guide channel 1196 may have a “U” shape for the adaptors 246, 256 to slide longitudinally along. The guide channel 1196 may comprise a cantilevered beam extending through the sections 1194, 1192, with the fixed connection 1198 supporting the guide channel 1196. The fixed connection 1198 impedes rotational movement of the sections 1194, 1192 relative to the central portion 1211 of the delivery housing 232.

[0707] As such, FIG. 154 illustrates an implementation, in which a proximal end portion of the guide channel 1200 (corresponding to the guide channel 1196) couples to the delivery housing 232 with a rotation control in the form of a pivot joint 1202. In some implementations, the proximal end portion of the guide channel 1200 may have a bearing surface 1204 that may rotate within an arcuate channel of the delivery housing 232. In some implementations, the proximal end portion of the guide channel 1200 may have a radially flanged surface 1206 that may impede axial movement of the guide channel 1200 relative to the delivery housing 232. In some implementations, the pivot joint 1202 may be positioned at the interface between the proximal end of the section 1194 and the distal end of the central portion 1211 of the delivery housing 232. In some implementations, the pivotal coupling of the guide channel 1200 allows the guide channel 1200 to rotate about the longitudinal axis of the handle and accordingly rotate the adaptors 246, 256 positioned within the guide channel 1200. In some implementations, the rotation of the adaptors 246, 256 produces a corresponding rotation of the outer sheath assembly 22 and the mid shaft assembly 21, thus rotating the treatment device about the longitudinal axis of the elongate shaft. For example, the outer retention member or ring 46 and / or the capsule 38 may rotate torotate the treatment device. The inner retention member 50 may be pivotally coupled to allow the treatment device to rotate with the outer retention member or ring 46 and / or the capsule 38.

[0708] FIG. 155 illustrates the corresponding rotation of the distal portion 1208 of the delivery housing 232. The distal portion 1208 of the delivery housing 232 rotates relative to a portion of the delivery housing 232 that is positioned proximal (e.g., the central portion 1211 of the delivery housing 232 and the proximal end portion 1209 of the delivery housing 232). In some implementations, the distal portion 1208 of the handle, including the actuator assemblies 242, 252 and the section 1192, may comprise a distal end portion of the handle, and may rotate together relative to the rail housing 230 and to the central portion 1211 of the delivery housing 232 and to the proximal end portion 1209 of the delivery housing 232. In some implementations, the proximal end portion of the guide channel 1200 may rotate within the section 1194, and thus the section 1194 may appear non-rotational or static with respect to the rotation of the section 1192 (although the guide channel 1200 rotates within the interior of the section 1194). A user may grip the outer surface of the delivery housing 232 at the section 1192 to rotate the distal portion 1208.

[0709] FIGS. 156 and 157 illustrate a schematic cross-sectional view of the rotation of the guide channel 1200.

[0710] Variations may be provided as desired. FIG. 158, for example, illustrates an implementation in which the rotation control includes an actuator assembly 1210 for selectively allowing the distal portion 1208 of the delivery housing 232 to rotate relative to the central portion 1211 of the delivery housing 232. In some implementations, the actuator assembly 1210 may comprise a lock actuator that is configured to lock a rotational position of the guide channel 1212 and thus impeding rotation of the distal portion 1208. In some implementations, the actuator assembly 1210 may include an axially slidable body in the form of a locking ring 1216 accessible via a user and positioned on an exterior of the delivery housing 232. In some implementations, connecting portions 1218 of the locking ring 1216 may extend through the delivery housing 232 to a locking surface 1220 positioned interior of the delivery housing 232.

[0711] In some implementations, the locking surface 1220 may comprise an axially slidable body. The locking surface 1220 may selectively engage with a corresponding locking surface 1222 coupled to the proximal end portion of the guide channel 1212. In some implementations, the locking surface 1222 may be positioned on a rotational body 1224 (e.g., a disk) coupled to theguide channel 1212 and configured to rotate with the locking surfaces 1220, 1222 disengaged, and configured to lock in position with the surfaces 1220, 1222 engaged. The locking surface 1220, for example, may include a ring having teeth configured to engage corresponding teeth of the rotational body 1224. The ring may have teeth facing radially inward, and may engage with teeth of the rotational body 1224 facing radially outward. Other configurations may be utilized in some implementations. The engagement may impede rotation of the rotational body 1224. The locking ring 1216 may be slid distally for engagement and locking of the rotational position of the rotational body 1224, and retracted proximally for release of the rotational body 1224.

[0712] FIG. 160, for example, illustrates retraction of the locking ring 1216 to allow the rotational body 1224 to rotate. FIG. 161 illustrates advancement of the locking ring 1216 to lock the locking surfaces 1220, 1222 together. The relative spacing of the teeth of the rotational body 1224 and locking surface 1220 may define the incremental amount of rotation (i.e. , the angle of rotation) of the treatment device that may be locked with the actuator assembly 1210. In some implementations, a spring may be utilized to slide the actuator assembly 1210. The spring, for example, may retain the actuator assembly 1210 in a distal position (e.g., a locked position) and the force of the spring may be overcome with a proximal retraction (e.g., an unlocked position).

[0713] Other configurations may be utilized in some implementations.

[0714] FIG. 162 illustrates an implementation in which the handle includes a bearing surface 1230 for maintaining a rotational position of the distal portion 1208 of the delivery housing 232 relative to a central portion 1211 of the delivery housing 232. The bearing surface 1230 may be configured for the guide channel 1232 to rotate about and may comprise a detent engagement surface. The detent engagement surface may include a plurality of teeth. The proximal end portion of the guide channel 1232 (marked in FIG. 163) may include a corresponding bearing surface 1234 comprising a detent engagement surface. A user may produce rotation of the guide channel 1232 (via rotation of the section 1192 for example) such that the bearing surfaces 1230, 1234 slip relative to each other to produce rotation. The force of rotation may allow for the bearing surfaces to slip (as indicated in FIG. 164), yet upon removal of the force the bearing surfaces 1230, 1234 may maintain a rotational position of the guide channel 1232.

[0715] FIG. 165 illustrates an implementation in which a bearing surface in the form of a frictional element maintains a rotational position of the distal portion 1208 of the delivery housing232 relative to a central portion 1211 of the delivery housing 232. The frictional element may have the form of an elastomeric body 1240 (c.g., an O-ring) that may frictionally engage with a bearing surface 1242 of the guide channel 1244 (marked in FIG. 166). The bearing surface 1242 may be smooth (e.g., lacking teeth) in some implementations. The friction provided by the elastomeric body 1240 may be overcome with the force of rotation (via rotation of the section 1192 for example).

[0716] FIGS. 167 and 168 illustrate an implementation in which an actuator assembly includes a locking member 1250 that is removable to allow the guide channel 1200 to rotate. The outer surface of the housing may include a plurality of apertures 1252 for receiving the locking member 1250 at a variety of angles. The apertures 1252 may be spaced circumferentially from each other at defined intervals. The spacing or angle between the apertures 1252 may define the incremental amount of rotation (i.e., the angle of rotation) of the treatment device that may be locked with the actuator assembly. The locking member 1250 may comprise a pin or other form of removable locking member. The guide channel 1200 may be rotated with the locking member 1250 removed (as represented in FIG. 168). The locking member 1250 may be reinserted in a different aperture 1252 to lock the rotational position of the guide channel 1200.

[0717] FIG. 169 illustrates an implementation in which a detent 1260 includes a spring biased pin that presses against teeth on a bearing surface 1262 of the guide channel 1264. The force provided by the detent 1260 may be overcome with the force of rotation (via rotation of the section 1192 for example).

[0718] FIGS. 170 and 171 illustrate an implementation of an actuator assembly in which a spring biased pin 1270 positioned on the delivery housing 232 may engage a bearing surface 1272 of the guide channel 1274 having teeth. The pin 1270 may be retracted via a pull body 1276 accessible via a user.

[0719] FIGS. 172 and 173 illustrate an implementation of an actuator assembly in which a spring biased pin 1278 protrudes radially outward from an outer bearing surface of the guide channel 1280 to fit into a corresponding aperture 1282 on the inner surface of the delivery housing 232. The rotational orientation of the guide channel 1280 may be locked in such a configuration. A push button 1284 (which may be coupled to a spring-biased pin) may be operated to press the pin 1278 and allow for rotation (as represented in FIG. 173). The guide channel 1280 may rotateuntil another pin 1278 fits into the aperture 1282. The position and spacing of the pins 1278 may define the incremental amount of rotation (i.c., the angle of rotation) of the treatment device that may be locked with the actuator assembly.

[0720] FIGS. 174-176 illustrates an implementation in which one or more pressure surfaces 1290 may press against a flanged rotational surface 1292 for the guide channel. An actuator assembly 1294 may be accessible by a user, who may press the actuator assembly 1294 to apply a pressing force to the rotational surface 1292 to impede rotation of the surface 1292. For example, deflection surfaces 1296 may be provided to press angled surfaces 1298 towards the rotational surface 1292 to apply the pressing force. The pressure surfaces 1290 may comprise elastomeric surfaces (e.g., O-rings) that may be supported by backing plates 1300. Other configurations may be utilized in some implementations.

[0721] A configuration shown in FIGS. 174-176 represents actuation to lock the rotational surface 1292 in position. However, in some implementations the configuration may be altered such that the rotational surface 1292 is normally locked in position and operation of the actuator assembly 1294 releases the locked configuration (to allow for rotation). For example, the actuator assembly 1294 may be retracted to release the locked configuration.

[0722] Variations may be provided in which an actuator assembly locks or releases the distal portion 1299 of the housing relative to the central portion 1301 of the housing to control rotation of the distal portion 1299 of the housing. In some implementations, an actuator assembly may be utilized to engage between the portions of the housing (e.g., the portions 1299, 1301). FIGS. 177- 180, for example, illustrate an implementation in which an actuator assembly 1310 is positioned on the distal portion 1299 of the delivery housing 232 and engages a locking surface 1312 on the central portion 1301 of the delivery housing 232. In some implementations, the actuator assembly 1310 may be positioned at the juncture between the distal portion 1299 of the delivery housing 232 and the central portion 1301 of the delivery housing 232. The actuator assembly 1310 may include a push button (which may be flush with the outer surface of the distal portion 1299 of the delivery housing 232 as shown in FIG. 177) and may include an axially extending arm 1314 (marked in FIGS. 179 and 180) that may engage the locking surface 1312 (e.g., teeth) on the central portion 1301.

[0723] In some implementations, the guide channel 1200 may be able to rotate about a bearing surface as disclosed herein. The actuator assembly 1310 may be pressed to disengage the arm 1314 from the locking surface 1312 to allow the distal portion 1299 to rotate relative to the central portion 1301. The actuator assembly 1310 may be released to engage the arm 1314 and the locking surface 1312 to maintain a rotational position. The guide channel 1200 may rotate about the longitudinal axis of the handle and accordingly rotate the adaptors 246, 256 positioned within the guide channel 1200. The rotation of the adaptors 246, 256 produces a corresponding rotation of the outer sheath assembly 22 and the mid shaft assembly 21, thus rotating the treatment device about the longitudinal axis of the elongate shaft.

[0724] In some implementations, the position of the actuator assembly 1310 may be reversed, with the actuator assembly 1310 appealing on the central portion 1301 (as represented in FIG. 181) and the arm 1314 extending axially distal to engage a locking surface on the distal portion 1299.

[0725] Other configurations may be utilized in some implementations. FIGS. 182 and 183, for example, illustrate an implementation in which the actuator assembly 1320 includes a protruding push button for a user to press to unlock the arm 1322 from the locking surface 1324. The actuator assembly 1320 may be positioned on the distal portion 1299 or on the central portion 1301 (as shown in FIG. 184) as desired.

[0726] Variations may be provided. FIGS. 185-187, for example, illustrate an implementation in which an actuator assembly 1330 includes a push button 1332 coupled to deflectable arms 1334 having locking features 1336 for engaging corresponding locking surfaces 1338 (e.g. teeth) on the other portion of the delivery housing 232 to which the portion 1340 of the delivery housing 232 connects. The arms 1334 may be circumferentially arranged and may be bowed radially outward, yet biased to contract radially inward. Pressure on the push button 1332 deflects the arms 1334 outward, which releases the locking features 1336 from the surfaces 1338, thus allowing the other portion of the housing to rotate. FIG. 187 illustrates an isolated view of the push button 1332 of the actuator assembly 1330.

[0727] FIG. 188 illustrates an implementation including an actuator assembly 1350 having two push buttons 1352, 1354 to be pressed inward to deflect the corresponding arms 1356 radially outward. The radially outward movement of the arms 1356 releases the locking features 1358 from the corresponding locking surfaces 1360 (e.g., teeth) of the other portion of the housing. Thearms 1356 may be biased to contract radially inward, yet the force upon the buttons 1352, 1354 deflects the arms 1356 radially outward.

[0728] FIG. 189 illustrates an implementation in which the actuator assembly 1370 is biased with a spring 1372 to a locked configuration. Applying a force to the push button 1374 disengages the locking features 1376 from the corresponding locking surface 1378 (e.g., teeth) of the other portion of the housing.

[0729] The configurations of FIGS. 177-189 may be utilized with a connection between a distal portion of a housing and a central portion of a housing. In other configurations, the configurations may be utilized between a central portion of a housing and a proximal portion of a housing. For example, in a configuration in which rotation of features of a proximal portion of a housing is desired relative to a central portion of a housing, then the configurations of FIGS. 177- 189 may be utilized for such a purpose.

[0730] The features of FIGS. 132-189 may be utilized solely or in combination with any other example herein.

[0731] The rotational features of FIGS. 132-189 may be utilized to rotate a treatment device such that the treatment device is provided in a desired rotational orientation relative to an implantation site. For example, in a configuration in which a prosthetic heart valve is implanted, the rotational features may be utilized to place the prosthetic heart valve in the desired rotational orientation relative to the native heart valve. In an implementation in which the prosthetic heart valve has an asymmetric configuration of anchors and / or an unequal spacing of anchors, then such rotation may place the anchors in a desired orientation relative to the native heart valve. The rotational features of FIGS. 132-189 may be utilized for 360 degree rotation in some implementations or a subset of a full rotation (e.g., 180 degrees, or up to 90 degrees, or up to 60 degrees, or up to 45 degrees, as desired).

[0732] In some implementations, imaging may be utilized in a deployment procedure to help determine a rotational orientation of the treatment device (e.g., prosthetic heart valve) relative to an implantation site (e.g., native heart valve).

[0733] In some implementations, one or more of the rotational features of FIGS. 132-189 (or FIG. 95) and / or described herein may be utilized to rotate the treatment device about thelongitudinal axis of the elongate shaft assembly to a desired rotational orientation. Various rotational orientations may be desired for different purposes. In some implementations, a particular portion (e.g., an anchor, a pair of anchors, multiple anchors, a frame section, an outer frame section, an extension, etc.) of the device may be configured for placement in a certain area of the anatomy, e.g., for better anchoring, for providing different treatments, for optimizing pressure exerted on the anatomy by the device, for interacting better with another device and / or a particular part of the anatomy, for avoiding interaction with certain anatomy and / or other devices, etc. In some implementations, such rotational features may be utilized in combination with an asymmetric configuration of anchors (e.g., any asymmetric configuration as disclosed herein) to rotationally orient the section of the treatment device that lacks anchors or has a reduced presence of anchors with the portion of the heart or heart valve annulus that preferably lacks the presence of one of the anchors. In some implementations, a particular anchor, a pair of anchors, multiple anchors, a frame section, etc. may be configured for placement in a particular region even on a device with a symmetrical configuration and / or equal distribution, such that orienting the device appropriately is desirable.

[0734] In some implementations, in a tricuspid deployment, a septal leaflet may preferably lack an anchor at that position because of potential electrical conduction disturbance issues stemming from the presence of an anchor. The treatment device may be rotated about the longitudinal axis of the elongate shaft assembly to position the section of the treatment device that lacks anchors or has a reduced presence of anchors with this portion of the native valve, e.g., to reduce the potential for electrical conduction disturbance issues or the possibility of pseudo aneurysms at the location of the Bundle of His. Other benefits from a rotation of the treatment device may result. The rotational features may be utilized with any implementation of treatment device disclosed herein.

[0735] In some implementations, a treatment device having eight anchors, e.g., with a removed ninth anchor at a position, may be rotated by a rotational feature disclosed herein to position the region of the missing ninth anchor at the portion of the heart or heart valve annulus that preferably lacks the presence of one of the anchors. In some implementations, the anchor may remain but be configured for placement in a particular location / region. Various numbers of anchors and various configurations and combinations of anchors are possible.

[0736] The use of the rotation features of FIGS. 132-189 (or FIG. 95) may be provided prior to deployment of the treatment device (e.g., when the treatment device is in a compressed or linearized configuration prior to deployment), or during a deployment procedure. The various forms of rotation controls and / or rotation mechanisms disclosed herein may be operated by a user to provide a desired rotational orientation of the treatment device relative to the implantation site. Other forms of rotation controls and / or rotation mechanisms may be utilized as desired.

[0737] In some implementations, the nose body shaft 140 may experience axial movement due to a lateral deflection of the elongate shaft. As such, and referring to FIG. 190, the actuator assembly 320 for the nose body shaft may be configured to prevent undesired rotation of the adaptor 324 for the nose body shaft. In some implementations, the threading 325 of the rotatable knob 322 may produce a tight interference fit with the threading 327 of the adaptor 324. The pitch of the threading 325 may be closely mated to the pitch of the threading 327 to reduce the possibility of undesired slippage. The material of the rotatable knob 322, however, may comprise a lubricous surface (e.g., PTFE, among others) to allow for desired rotation of the knob 322 relative to the threading 327 of the adaptor 324.

[0738] In some implementations, it may be desirable to provide the secondary direction of deflection of an elongate shaft assembly of a delivery system in an opposite direction (relative to a neutral axis) than represented by the pull tether 192 shown in FIG. 14. An opposite direction of deflection may beneficially allow the elongate shaft to be used for both tricuspid and mitral insertions (which may require opposite directions of secondary deflection from each other). Further, an opposite direction of deflection may allow for septal-lateral positioning of the elongate shaft assembly when approaching a tricuspid annulus via a jugular vein, as opposed to a femoral vein. As such, FIG. 191 illustrates an implementation of the intermediate or secondary bend portion 62 as shown in FIG. 14 in which the intermediate or secondary bend portion 1381 is configured to deflect in two directions (e.g., a positive angle, and a negative angle) in a plane relative to a neutral axis 1379 of the rail shaft. The rail shaft is configured to be in a linear configuration (as represented in FIG. 191) along the neutral axis 1379.

[0739] The intermediate or secondary bend portion 1381 may include at least two sections 1383, 1385 separated by a middle insert 1387. The sections may include a distal secondary section 1383 and a proximal secondary ...

Claims

1. WHAT IS CLAIMED IS:

1. A delivery system for a treatment device, the delivery system comprising: an elongate shaft assembly including: a first shaft including a distal end portion of the elongate shaft assembly; a treatment device retention area for retaining the treatment device; a rail shaft assembly including: a rail shaft adapted to slide relative to the first shaft, the rail shaft including: a first bend portion adapted to bend towards a first direction, a second bend portion adapted to bend towards a second direction that is opposed to the first direction, a first pull tether for bending the first bend portion, a second pull tether for bending the second bend portion, the second pull tether having a proximal end portion; a handle coupled to the elongate shaft assembly, the handle including: a first housing coupled to the rail shaft; a second housing coupled to the first shaft and adapted to engage the proximal end portion of the second pull tether, the second housing adapted to slide in a first direction relative to the first housing to produce a depth of the distal end portion of the elongate shaft assembly relative to the rail shaft and adapted to slide in a second direction relative to the first housing to retract the second pull tether to bend the second bend portion towards the second direction that is opposed to the first direction.

2. The delivery system of claim 1, further comprising an actuator assembly for sliding the second housing relative to the first housing.

3. The delivery system of claim 2, wherein the actuator assembly comprises a rotatable knob.

4. The delivery system of claim 2 or claim 3, wherein the second housing is adapted to engage the proximal end portion of the second pull tether at a position that is proximal of the actuator assembly.

5. The delivery system of any of claims 1-4, wherein the first bend portion comprises a first tube section having a first plurality of cuts for allowing bending towards the first direction, and the second bend portion comprises a second tube section having a second plurality of cuts positioned circumferentially opposed to the first plurality of cuts for allowing bending towards the second direction.

6. The delivery system of any of claims 1-5, further comprising a first compression coil surrounding the first pull tether and a second compression coil surrounding the second pull tether.

7. The delivery system of any of claims 1-6, wherein the rail shaft assembly includes: a third bend portion in the rail shaft that is adapted to bend towards a third direction that is transverse to the first direction; and a third pull tether for bending the third bend portion.

8. The delivery system of claim 7, wherein the rail shaft is configured to be in a linear configuration along a neutral axis, and the third bend portion is configured to deflect in a plane at a positive angle relative to the neutral axis and at a negative angle relative to the neutral axis.

9. The delivery system of claim 8, further comprising an actuator assembly configured to deflect the third bend portion to the positive angle and to the negative angle.

10. The delivery system of any of claims 7-9, wherein the rail shaft assembly includes: a fourth pull tether for producing movement of the third bend portion towards a fourth direction that is opposite to the third direction.

11. The delivery system of any of claims 7-10, wherein the third bend portion is positioned intermediate the first bend portion and the second bend portion.

12. The delivery system of any of claims 1-11, wherein the first shaft includes a capsule adapted to surround the treatment device retention area.

13. The delivery system of claim 12, further comprising an intermediate shaft positioned radially between the first shaft and the rail shaft, the intermediate shaft including a first plurality of cuts corresponding to a position of the first bend portion and a second plurality of cuts corresponding to a position of the second bend portion.

14. The delivery system of claim 12 or claim 13, further comprising an intermediate shaft positioned radially between the first shaft and the rail shaft, the intermediate shaft including an indicator for indicating a rotational orientation of the treatment device relative to the intermediate shaft.

15. The delivery system of claim 14, wherein the intermediate shaft includes an outer retention member for covering at least a portion of the treatment device, and the indicator is positioned on the outer retention member.

16. The delivery system of any of claims 1-15, further comprising a haptic indicator on the handle for indicating a transition between producing the depth of the distal end portion of the elongate shaft assembly relative to the rail shaft and the bending of the second bend portion towards the second direction that is opposed to the first direction.

17. The delivery system of any of claims 1-16, wherein the elongate shaft assembly includes a nose body, and the delivery system further comprises an actuator assembly on the handle for advancing or retracting the nose body, and the second housing is adapted to engage the proximal end portion of the second pull tether at a position that is distal of the actuator assembly.

18. The delivery system of any of claims 1-17, further comprising a catch assembly for engaging the proximal end portion of the second pull tether with the second housing.

19. The delivery system of any of claims 1-18, wherein the elongate shaft assembly includes a nose body assembly including a nose body shaft coupled to a nose body, the nose body shaft including an interior lumen for receiving a guide wire, and the delivery system further comprisesan alignment body positioned on the nose body assembly for rotationally aligning the treatment device relative to the alignment body.

20. The delivery system of claim 19, wherein the alignment body includes a fin protruding radially outward.

21. A delivery system for a treatment device, the delivery system comprising: an elongate shaft assembly including a device retention area for retaining the treatment device, and at least a portion of the elongate shaft assembly including: an interior lumen; a first bend portion adapted to bend towards a first direction; a second bend portion adapted to bend towards a second direction that is opposed to the first direction; a third bend portion that is adapted to bend towards a third direction that is transverse to the first direction; a first pull tether for bending the first bend portion; a second pull tether for bending the second bend portion; and a third pull tether for bending the third bend portion, and wherein at least one of the first pull tether, the second pull tether, or the third pull tether spirals within the interior lumen to be positioned circumferentially closer to one other of the first pull tether, the second pull tether, or the third pull tether.

22. A delivery system for a treatment device, the delivery system comprising: an elongate shaft assembly including a device retention area for retaining the treatment device, and at least a portion of the elongate shaft assembly including: a first bend portion adapted to bend towards a first direction; a second bend portion adapted to bend towards a second direction that is opposed to the first direction; a third bend portion that is adapted to bend towards a third direction that is transverse to the first direction;a first pull tether for bending the first bend portion and the second bend portion; and a second pull tether for bending the third bend portion.

23. The delivery system of claim 22, wherein the second bend portion is positioned proximal of the third bend portion and the first bend portion, and the third bend portion is positioned proximal of the first bend portion.

24. The delivery system of claim 22 or claim 23, wherein the first pull tether couples to the first bend portion at a first circumferential position and the first pull tether passes through the second bend portion at an angle that is circumferentially offset from the first circumferential position.

25. A delivery system for a treatment device, the delivery system comprising: an elongate shaft assembly including: a device retention area for retaining the treatment device; a sheath including a capsule for extending over the treatment device retention area, the sheath extending along a longitudinal axis; and a pull tether adapted to retract to apply a force to the sheath to bend the sheath in a direction transverse to the longitudinal axis.

26. A delivery system for a treatment device, the delivery system comprising: an elongate shaft assembly including a device retention area for retaining the treatment device, and at least a portion of the elongate shaft assembly being precurved to bend the elongate shaft assembly in a direction transverse to a longitudinal extent of the elongate shaft assembly.

27. The delivery system of claim 26, wherein the elongate shaft assembly includes a first shaft that is precurved and a second shaft that lacks a precurvature.

28. The delivery system of claim 27, wherein the first shaft is configured to be inserted relative to the second shaft in vivo to curve the second shaft.

29. A delivery system for a treatment device, the delivery system comprising: an elongate shaft assembly including: a device retention area for retaining the treatment device; and a nose body positioned at a distal tip of the elongate shaft assembly, the nose body being expandable in size and being retractable to deflect the elongate shaft assembly.

30. A delivery system for a treatment device, the delivery system comprising: an elongate shaft assembly including: a device retention area for retaining the treatment device; and a nose body positioned at a distal tip of the elongate shaft assembly, the nose body being adapted to engage a guide wire and being retractable to deflect the elongate shaft assembly upon retraction of the guide wire.

31. A prosthetic heart valve for replacing the function of a native heart valve, the prosthetic heart valve comprising: a self-expanding frame sized for deployment within the native heart valve, the frame having an inflow end portion and an outflow end portion, the frame including: an inner frame, and an outer frame positioned radially outward of the inner frame, the outer frame including a plurality of struts and including a plurality of elongate beams each having a proximal end portion coupled to at least one of the plurality of stmts and each extending in an outflow direction to a tip of the respective one of the elongate beams; a plurality of prosthetic valve leaflets positioned within an interior of the inner frame; and a plurality of anchors adapted to extend around native leaflets of the native heart valve, one, some, or all of the anchors adapted to press a native leaflet against a respective one of the elongate beams for securing the prosthetic heart valve within the native heart valve.

32. The prosthetic heart valve of claim 31, wherein each elongate beam includes an arm having a width, and the tip of each elongate beam includes a head having a width that is greater than the width of the arm.

33. The prosthetic heart valve of claim 32, wherein each head has a smooth outer surface.

34. The prosthetic heart valve of any of claims 31-33, wherein the plurality of struts form a lattice having an outflow end, and the proximal end portion of each elongate beam is coupled to a juncture of at least two of the plurality of struts at the outflow end of the lattice.

35. A prosthetic heart valve for replacing the function of a native heart valve, the prosthetic heart valve comprising: a self-expanding frame sized for deployment within the native heart valve, the frame having an inflow end portion and an outflow end portion; a plurality of prosthetic valve leaflets positioned within an interior of the frame; and a plurality of anchors adapted to extend around native leaflets of the native heart valve, the plurality of anchors being unequally spaced about an outer circumference of the prosthetic heart valve, and the plurality of anchors including a first of the anchors and a second of the anchors that bound a section of the outer circumference, and the first and the second of the anchors each extend to a lesser axial height in the inflow direction of the prosthetic heart valve than at least one other of the plurality of anchors.

36. A prosthetic heart valve for replacing the function of a native heart valve, the prosthetic heart valve comprising: a self-expanding frame sized for deployment within the native heart valve, the frame having an inflow end portion and an outflow end portion; a plurality of prosthetic valve leaflets positioned within an interior of the frame; a plurality of anchors each having a hook shape and adapted to extend around native leaflets of the native heart valve, the plurality of anchors being unequally spaced about an outer circumference of the prosthetic heart valve such that the outer circumference includes a section having a circumferential spacing between two adjacent anchors of the anchors that is larger than another circumferential spacing between two adjacent anchors of the anchors; and one or more imaging markers for indicating a position of the section.

37. The prosthetic heart valve of claim 36, wherein the one or more imaging markers comprise a fluoroscopic marker.

38. The prosthetic heart valve of claim 36 or claim 37, wherein the plurality of anchors includes a first of the anchors and a second of the anchors, the first anchor being adjacent to the section and including a first of the imaging markers, and the second anchor being adjacent to the first anchor such that the first anchor is circumferentially between the section and the second anchor, the second anchor including a second of the imaging markers.

39. The prosthetic heart valve of claim 38, wherein the first imaging marker has a different length than the second imaging marker.

40. A prosthetic heart valve for replacing the function of a native heart valve, the prosthetic heart valve comprising: a self-expanding frame sized for deployment within the native heart valve, the frame having an inflow end portion and an outflow end portion; a plurality of prosthetic valve leaflets positioned within an interior of the frame; a plurality of anchors each having a hook shape and a length and adapted to extend around native leaflets of the native heart valve, the plurality of anchors being unequally spaced about an outer circumference of the prosthetic heart valve such that the outer circumference includes a section having a circumferential spacing between two adjacent anchors of the anchors that is larger than another circumferential spacing between two adjacent anchors of the anchors; and an arm coupled to the frame and extending axially in an outflow direction to a tip of the arm, the arm being positioned at a circumferential position corresponding to the section and having a length that is less than the length of each of the plurality of anchors.

41. The prosthetic heart valve of claim 40, wherein each of the plurality of anchors includes a strut arm, and the arm is a shortened strut arm.

42. The prosthetic heart valve of claim 40 or claim 41 , wherein the frame includes an outer surface, and each of the plurality of anchors is positioned radially outward of the outer surface and the arm is positioned radially inward of the outer surface.

43. A prosthetic heart valve for replacing the function of a native heart valve, the prosthetic heart valve comprising: a self-expanding frame sized for deployment within the native heart valve, the frame having an inflow end portion and an outflow end portion; a plurality of prosthetic valve leaflets positioned within an interior of the frame; and a plurality of anchors adapted to extend around native leaflets of the native heart valve, one, some, or all of the anchors including a connecting portion for connecting to the self-expanding frame and extending to a respective tip of the anchor, at least one of the plurality of anchors being shaped such that the tip of the anchor is angled relative to the connecting portion of the anchor circumferentially towards a circumferentially adjacent anchor of the plurality of anchors.

44. The prosthetic heart valve of claim 43, wherein the at least one of the plurality of anchors is a first anchor, and the plurality of anchors includes a second anchor shaped such that the tip of the second anchor is angled relative to the connecting portion of the second anchor circumferentially towards the first anchor.

45. The prosthetic heart valve of claim 44, wherein the tip of the first anchor is angled towards a first circumferential direction, and the tip of the second anchor is angled towards a second circumferential direction that is opposite the first circumferential direction.

46. A prosthetic heart valve for replacing the function of a native heart valve, the prosthetic heart valve comprising: a self-expanding frame sized for deployment within the native heart valve, the frame having an inflow end portion and an outflow end portion; a plurality of prosthetic valve leaflets positioned within an interior of the frame; and a plurality of anchors adapted to extend around native leaflets of the native heart valve, one, some, or all of the anchors being spaced circumferentially from a circumferentially adjacentone of the plurality of anchors, and one, some, or all of the anchors protruding radially outward from the frame, a first anchor of the plurality of anchors being angled in a circumferential direction away from a circumferentially adjacent second anchor of the plurality of anchors such that a size of a circumferential gap between the first anchor and the second anchor is larger than a size of a circumferential gap between two other anchors of the plurality of anchors.

47. A prosthetic heart valve for replacing the function of a native heart valve, the prosthetic heart valve comprising: a self-expanding frame sized for deployment within the native heart valve, the frame having an inflow end portion and an outflow end portion; a plurality of prosthetic valve leaflets positioned within an interior of the frame; a plurality of anchors adapted to extend around native leaflets of the native heart valve; and a telescoping section adapted to allow an axial position of at least one of the plurality of anchors to be adjusted relative to an axial position of the self-expanding frame in vivo.

48. A prosthetic heart valve for replacing the function of a native heart valve, the prosthetic heart valve comprising: a self-expanding frame sized for deployment within the native heart valve, the frame having an inflow end portion and an outflow end portion; a plurality of prosthetic valve leaflets positioned within an interior of the frame; a plurality of anchors adapted to extend around native leaflets of the native heart valve and being coupled to the frame; and a release control adapted to allow at least one of the plurality of anchors to release from the frame and be removed from the frame in vivo.

49. A delivery system for a treatment device, the delivery system comprising: an elongate shaft assembly including a device retention area for retaining the treatment device, the elongate shaft assembly extending along a longitudinal axis; and a rotation control adapted to rotate the treatment device about the longitudinal axis of the elongate shaft assembly.

50. The delivery system of claim 49, wherein the elongate shaft assembly includes a first bend portion adapted to bend towards a first direction and a second bend portion adapted to bend towards a second direction that is opposed to the first direction.

51. The delivery system of claim 50, wherein the elongate shaft assembly includes a rail shaft having the first bend portion and the second bend portion.

52. The delivery system of claim 51, wherein the elongate shaft assembly includes a first shaft surrounding the device retention area, and the rail shaft is adapted to slide relative to the first shaft to vary a depth of the device retention area relative to the rail shaft.

53. The delivery system of any of claims 49-52, wherein the elongate shaft assembly includes a distal end portion, and the rotation control includes a pivot joint at the distal end portion for producing a rotation of the treatment device about the longitudinal axis of the elongate shaft assembly.

54. The delivery system of claim 53, wherein the pivot joint is configured to rotate the treatment device about the longitudinal axis in a single rotational direction based on an oscillatory motion of a body extending along the elongate shaft assembly.

55. The delivery system of claim 53 or claim 54, wherein the pivot joint includes a ratcheting body.

56. The delivery system of any of claims 49-55, further comprising a retention member for retaining the treatment device within the device retention area, and wherein the rotation control is adapted to rotate the retention member to produce a corresponding rotation of the treatment device about the longitudinal axis of the elongate shaft assembly.

57. The delivery system of any of claims 49-56, further comprising a handle coupled to a proximal end portion of the elongate shaft assembly, and wherein the rotation control includes afirst portion of the handle configured to rotate relative to a second portion of the handle to rotate the treatment device about the longitudinal axis of the elongate shaft assembly.

58. The delivery system of claim 57, wherein the elongate shaft assembly includes a first shaft surrounding the device retention area, and the elongate shaft assembly includes a rail shaft adapted to slide relative to the first shaft to vary a depth of the device retention area relative to the rail shaft; and the handle includes; a first housing coupled to the rail shaft, and a second housing coupled to the first shaft.

59. The delivery system of claim 58, wherein the second housing is configured to rotate relative to the first housing to rotate the treatment device about the longitudinal axis of the elongate shaft assembly.

60. The delivery system of claim 59, wherein the second housing includes a longitudinal slot for engagement with the first housing, and the longitudinal slot has a circumferential width allowing rotation of the second housing relative to the first housing to rotate the treatment device about the longitudinal axis of the elongate shaft assembly.

61. The delivery system of any of claims 58-60, wherein a first portion of the second housing is configured to rotate relative to a second portion of the second housing to rotate the treatment device about the longitudinal axis of the elongate shaft assembly.

62. The delivery system of claim 61, wherein the first portion of the second housing is a distal portion of the second housing, and the second portion of the second housing is positioned proximal of the first portion.

63. The delivery system of claim 61 or claim 62, wherein the rotation control includes a pivot joint positioned between the first portion of the second housing and the second portion of the second housing.

64. The delivery system of any of claims 61-63, wherein the rotation control includes an actuator assembly for selectively allowing the first portion of the second housing to rotate relative to the second portion of the second housing.

65. The delivery system of claim 64, wherein the actuator assembly includes a push button or a pin positioned on the handle.

67. A treatment device usable for treating a native heart valve, the treatment device comprising an expandable frame deployable within the native heart valve having a plurality of anchors that can extend around one or more native leaflets of the native heart valve.

68. The treatment device of claim 67, wherein the plurality of anchors are positioned at multiple locations around an outer circumference of the treatment device.

69. The treatment device of any one of claims 67-68, wherein the frame has an inflow end portion and an outflow end portion configured such that blood can flow into the inflow end portion and out of the outflow end portion.

70. The treatment device of any one of claims 67-69, wherein the treatment device is a prosthetic heart valve comprising a plurality of prosthetic valve leaflets positioned within an interior of the frame.

71. The treatment device of any one of claims 67-70, wherein the plurality of anchors each have a hook shape72. The treatment device of any one of claims 67-71, wherein an outer circumference of the treatment device includes a section having a circumferential spacing between two adjacentanchors of the plurality of anchors that is larger than another circumferential spacing between two adjacent anchors of the anchors.

73. The treatment device of claim 72, further comprising one or more imaging markers for indicating a position of the section.

74. The treatment device of claim 73, wherein the plurality of anchors includes a first anchor of the plurality of anchors and a second anchor of the plurality of anchors, wherein the first anchor is adjacent to the section and includes a first marker of the one or more imaging markers, and the second anchor is adjacent to the first anchor such that the first anchor is circumferentially between the section and the second anchor, the second anchor including a second marker of the one or more imaging markers.

75. The treatment device of any one of claims 72-74, wherein the section is a first section of the outer circumference, and the outer circumference includes a second section, at least some of the plurality of anchors being spaced equally within the second section.

76. The treatment device of claim 75, wherein the first section lacks one of the anchors at the equal spacing positioning of the anchors that are within the second section.

77. The treatment device of any one of claim 72-76, further comprising an arm coupled to the frame and extending axially in an outflow direction to a tip of the arm.

78. The treatment device of claim 77, wherein the arm is positioned at a circumferential position corresponding to the section and has a length that is less than the length of each of the plurality of anchors.

79. The treatment device of claim 78, wherein each of the plurality of anchors comprises a strut arm, and the arm is a shortened strut ami.

80. The treatment device of any one of claim 72-79, wherein the frame comprises an inner frame and an outer frame positioned radially outward of the inner frame.

81. The treatment device of claim 80, wherein the outer frame includes a plurality of struts and a plurality of elongate beams each having a proximal end portion coupled to at least one of the plurality of struts.

82. The treatment device of claim 81, wherein each anchor of the plurality of anchors is adapted to press a native leaflet against a respective one of the elongate beams for securing the treatment device within the native heart valve.

83. The treatment device of any one of claims 72-82, wherein in each anchor of the plurality of anchors includes a connecting portion for connecting to the frame and extending to a respective tip of the anchor.

84. The treatment device of claim 83, wherein at least one of the plurality of anchors is configured such that a tip of the anchor is angled relative to the connecting portion of the anchor circumferentially towards a circumferentially adjacent anchor of the plurality of anchors.

85. The treatment device of any one of claims 83-84, wherein the at least one of the plurality of anchors is a first anchor, and the plurality of anchors includes a second anchor shaped such that the tip of the second anchor is angled relative to the connecting portion of the second anchor circumferentially towards the first anchor, and wherein the tip of the first anchor is angled towards a first circumferential direction, and the tip of the second anchor is angled towards a second circumferential direction that is opposite the first circumferential direction.

86. The treatment device of any one of claims 83-85, wherein the plurality of anchors includes a third anchor positioned circumferentially between the first anchor and the second anchor, and wherein the first anchor and the second anchor circumferentially converge towards the third anchor.

87. The treatment device of any one of claims 72-86, wherein at least one anchor of the plurality of anchors is configured such that it can be adjusted axially relative to a portion of the frame.

88. The treatment device of claim 87, wherein a telescoping section is useable to adjust the position of the at least one anchor axially relative to a portion of the frame.

89. The treatment device of any one of claims 72-88, further comprising a release control configured to allow at least one anchor of the plurality of anchors to release from the frame and be removed from the frame.

90. A system comprising: the treatment device of any one of claims 72-89, and a delivery system configured for delivering the treatment device to a location inside a body of a subject, wherein the delivery system includes an elongate shaft assembly including a first shaft including a distal end portion of the elongate shaft assembly, a handle coupled to the elongate shaft assembly, and a device retention area for retaining the treatment device.

91. The system of claim 90, wherein the delivery system includes a rail shaft assembly including a rail shaft adapted to slide relative to the first shaft.

92. The system of claim 91, wherein the rail shaft includes a first bend portion adapted to bend towards a first direction, a second bend portion adapted to bend towards a second direction that is opposed to the first direction, a first pull tether for bending the first bend portion, a second pull tether for bending the second bend portion.

93. The system of any one of claims 91-92, wherein the handle includes: a first housing coupled to the rail shaft; a second housing coupled to the first shaft and adapted to engage the proximal end portion of the second pull tether, the second housing adapted to slide in a first direction relative to the first housing to produce a depth of the distal end portion of the elongate shaft assembly relative to the rail shaft and adapted to slide in a second direction relative to the firsthousing to retract the second pull tether to bend the second bend portion towards the second direction that is opposed to the first direction.

94. The system of claim 93, wherein the rail shaft assembly includes a third bend portion in the rail shaft that is adapted to bend towards a third direction that is transverse to the first direction; and a third pull tether for bending the third bend portion.

95. The system of any one of claims 91-94, further comprising an indicator for indicating a transition between producing the depth of the distal end portion of the elongate shaft assembly relative to the rail shaft and the bending of the second bend portion towards the second direction that is opposed to the first direction.

96. The system of any one of claims 90-95, wherein at least a portion of the elongate shaft assembly includes: a first bend portion adapted to bend towards a first direction; a second bend portion adapted to bend towards a second direction that is opposed to the first direction; a third bend portion that is adapted to bend towards a third direction that is transverse to the first direction; a first pull tether for bending the first bend portion; a second pull tether for bending the second bend portion; and a third pull tether for bending the third bend portion.

97. The system of claim 96, wherein at least one of the first pull tether, the second pull tether, or the third pull tether spirals within the interior lumen to be positioned circumferentially closer to one other of the first pull tether, the second pull tether, or the third pull tether.

98. The system of any one of claims 72-97, wherein the delivery system includes a nose body positioned at a distal tip of the elongate shaft assembly.

99. The system of claim 98, wherein the nose body is expandable in size.

100. The system of any one of claims 98-99, wherein the elongate shaft assembly includes a nose body shaft coupled to the nose body, the nose body shaft adapted to be retracted to retract the nose body.

101. The system of one of claims 98-100, wherein the nose body is retractable to deflect the elongate shaft assembly upon retraction of a guide wire.

102. The system of any one of claims 98-101, wherein the nose body is adapted to engage a guide wire.

103. The system of any one of claims 90-102, wherein the delivery system further comprises a rotation control adapted to rotate the treatment device about the longitudinal axis of the elongate shaft assembly when the treatment device is coupled to the delivery system.

104. The system of claim 103, wherein the elongate shaft assembly includes a first shaft surrounding the device retention area, and a rail shaft adapted to slide relative to the first shaft to vary a depth of the device retention area relative to the rail shaft.

105. The system of any one of claims 103-104, wherein the elongate shaft assembly includes a distal end portion, and the rotation control includes a pivot joint at the distal end portion for producing a rotation of the treatment device about the longitudinal axis of the elongate shaft assembly.

106. The system of claim 105, wherein the pivot joint is configured to rotate the treatment device about the longitudinal axis in a single rotational direction based on an oscillatory motion of a body extending along the elongate shaft assembly.

107. The system of claim 106, wherein the delivery system further comprises a handle coupled to a proximal end portion of the elongate shaft assembly, and the rotation control includes an actuator assembly for producing the oscillatory motion of the body and being positioned on the handle.

108. The system of any one of claims 105-107, wherein the pivot joint includes a ratcheting body.

108. The system of any one of claims 105-108, wherein the pivot joint includes a slotted cam body engaged with an axially displaceable body, the slotted cam body configured to rotate to produce the rotation of the treatment device when the axially displaceable body displaces axially relative to the slotted cam body.

109. The system of any of claims 103-108, further comprising a retention member for retaining the treatment device within the device retention area, and wherein the rotation control is adapted to rotate the retention member to produce a corresponding rotation of the treatment device about the longitudinal axis of the elongate shaft assembly.

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