Attachment assemblies for prosthetic devices

Abstract

Attachment assemblies for attaching a device or implant to a delivery catheter. The attachment assemblies may be utilized to attach the device or implant to the delivery catheter in a medical setting or surgical facility. Units may be provided for attachment to the delivery catheter. The units may comprise devices or implants (such as prosthetic heart valves, etc.) and a tether assembly coupled to at least a portion of the device or implant. The units are adapted to be attached to the delivery catheter.

Description

Attorney Docket No: TMTTMT-23254WO01ATTACHMENT ASSEMBLIES FOR PROSTHETIC DEVICESCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Application No. 63 / 696,818, filed September 19, 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. The valves allow blood to flow downstream, but block blood from flowing upstream. Diseased heart valves exhibit impairments such as narrowing of the valve or regurgitation, which inhibit the valves’ ability to properly control blood flow. Such impairments can reduce the heart’s blood-pumping efficiency and can result in a debilitating and life-threatening condition. For example, valve insufficiency can lead to conditions such as heart hypertrophy and dilation of the ventricle. Thus, there is a significant desire to treat heart valve disease and improve the lives of people with heart valve disease. Being able to easily navigate to a native valve (e.g., mitral valve, tricuspid valve, etc.) and fix any valve issues is desirable, but very 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] Implementations of the present disclosure may be directed to a device or implant, which may comprise a device or prosthesis such as but not limited to a replacement heart valve. Further examples are directed to methods of use to deliver and / or controllably deploy a device, such as but not limited to a treatment device, a repair device, an implant, a replacement heart valve, etc. to a desired location within the body.Attorney Docket No: TMTTMT-23254WO01

[0005] In some implementations, attachment assemblies may be provided for attaching a device or implant to a delivery catheter. The attachment assemblies may be utilized to attach the device or implant to the delivery catheter in a medical setting or surgical facility. In some implementations, the attachment assemblies may be utilized to attach the device or implant to the delivery catheter during a medical procedure preparatory step involved with preparing the delivery system for use.

[0006] In some implementations, the medical procedure preparatory step may be part of a delivery system preparatory procedure prior to insertion of the delivery system into a body of a subject (e.g., a living animal, a simulation, etc.).

[0007] In some implementations, units may be provided as part of or for attachment to the delivery catheter. The units may include devices or implants (such as prosthetic heart valves, repair devices, treatment devices, etc.). The units may be adapted to be attached to the delivery catheter.

[0008] In some implementations, a tether assembly is coupled to at least a portion of the device or implant.

[0009] In some implementations, the device or implant is configured as a replacement heart valve, and methods for delivering the replacement heart valve to a native heart valve, such as a mitral valve, an aortic valve, or a tricuspid valve, are provided.

[0010] In some implementations, a delivery system for a device (e.g., a treatment device, a repair device, a prosthetic heart valve, implant, any of the devices discussed above or elsewhere herein, etc.). In some implementations, the delivery system may comprise a delivery catheter having an elongate shaft for advancing the device (e.g., prosthetic heart valve, etc.) through vasculature of a subject (e.g., a living animal, a simulation, etc.) to a treatment or implantation site.

[0011] In some implementations, the delivery system may also or otherwise comprise and / or be couplable with a unit including or containing: the device (e.g., a prosthetic heart valve, a treatment device, a repair device, an implant, etc.).

[0012] In some implementations, the device includes a frame (e.g., an expandable frame, a self-expanding frame, a mechanically-expanding frame, a balloon-expanding frame, a stent frame, a double stent frame, etc.). In some implementations, the device also or otherwise includes a plurality of leaflets disposed within a lumen of the frame for allowing one-way flow of blood, e.g., when the device is configured as a valve such as a prosthetic heart valve.Attorney Docket No: TMTTMT-23254WO01

[0013] In some implementations, the delivery system can include a tether assembly coupled to at least a portion of the device (e.g., prosthetic heart valve, etc.). The tether assembly can be in addition to any other components of a delivery system described herein, but is not required. In some implementations, the tether assembly is adapted to be attached to the delivery catheter.

[0014] In some implementations, a medical system may comprise a unit including: a device (e.g., a prosthetic heart valve, a treatment device, a repair device, an implant, any of the devices described above or elsewhere in this disclosure, etc.). In some implementations, the system may comprise a tether assembly coupled to at least a portion of the device (e.g., prosthetic heart valve, etc.). In some implementations, the tether assembly is connectable or operable with a delivery catheter to thereby couple the unit to the delivery catheter.

[0015] In some implementations, the unit or device includes a plurality of eyelets.

[0016] In some implementations, the system comprises a tether assembly (e.g. which can be the same as or similar to any other tether assembly described elsewhere herein) adapted to couple to the plurality of eyelets. In some implementations, the tether assembly is adapted to couple the device (e.g., prosthetic heart valve, etc.) to a delivery catheter.

[0017] In some implementations, the system can comprise a tether threading device for threading the tether assembly through the plurality of eyelets.

[0018] In some implementations, a method may comprise providing a delivery catheter having an elongate shaft for advancing a device (e.g., a prosthetic heart valve, a treatment device, a repair device, etc.) through vasculature of a subject (e.g., a living animal, a simulation, etc.) to a treatment site or implantation site.

[0019] In some implementations, the method can comprise providing or obtaining a unit including: the device (e.g., a prosthetic heart valve, a treatment device, a repair device, etc.).

[0020] In some implementations, the device has a frame (e.g., an expandable frame, a selfexpanding frame, a mechanically-expanding frame, a balloon-expanding frame, a stent frame, a double stent frame, etc.). The device and / or frame can be the same as or similar to any other devices and / or frames described elsewhere herein. In some implementations, the device additionally or otherwise comprises a plurality of leaflets (e.g., disposed within a lumen of the frame) for allowing one-way flow of blood, e.g., when configured as a valve or prosthetic heart valve.Attorney Docket No: TMTTMT-23254WO01

[0021] In some implementations, the unit can additionally or alternatively comprise a tether assembly coupled to at least a portion of the device (c.g., prosthetic heart valve, etc.). In some implementations, the method can comprise attaching the tether assembly to the delivery catheter.

[0022] In some implementations, the device includes a plurality of eyelets (e.g., as part of a frame, etc.). In some implementations, the method can comprise providing a tether assembly adapted to couple to the plurality of eyelets. In some implementations, the tether assembly is adapted to couple the device (e.g., prosthetic heart valve, etc.) to a delivery catheter.

[0023] In some implementations, the methods herein can comprise utilizing a tether threading device to thread the tether assembly through the plurality of eyelets.

[0024] In some implementations, a method can comprise providing a unit including: a device having a frame and / or a tether assembly. In some implementations, the unit can include a release assembly securing the tether assembly to at least a portion of the device.

[0025] In some implementations, the method can comprise providing a delivery catheter. In some implementations, the delivery catheter can include an elongate shaft for advancing the device through vasculature of a subject to a treatment or implantation site. In some implementations, the delivery catheter can include an elongate partition positioned in the elongate shaft.

[0026] In some implementations, the elongate partition can be configured for at least a portion of the tether assembly to extend through. In some implementations, the elongate partition can additionally or alternatively be configured for at least a portion of the release assembly to extend through. In some implementations, the elongate partition can additionally or alternatively be configured to separate the portion of the tether assembly from the portion of the release assembly.

[0027] In some implementations, the method can comprise advancing a snare assembly distally through the elongate partition for reconnection with the tether assembly, e.g., if the snare assembly previously lost a connection with the tether assembly or otherwise. In some implementations, the method can additionally or alternatively comprise advancing a snare assembly distally through the elongate partition for reconnection with the release assembly e.g., if the snare assembly previously lost a connection with the release assembly or otherwise.Attorney Docket No: TMTTMT-23254WO01

[0028] 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.

[0029] 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 comprise or consist of) sterilization of one or more systems, devices, apparatuses, components, etc. herein (e.g., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.).BRIEF DESCRIPTION OF THE DRAWINGS

[0030] FIG. 1 illustrates a side view of a delivery system for a device or implant.

[0031] FIG. 2 shows a perspective view of an outer sheath subassembly of a delivery device of the delivery system of FIG. 1.

[0032] FIG. 3 illustrates a side cross-sectional view of a capsule subassembly of the outer sheath subassembly of FIG. 2.

[0033] FIG. 4 shows a perspective view of a capsule stent, or distal hypotube, of the outer sheath subassembly of FIG. 2.

[0034] FIG. 5 schematically illustrates how a portion of a liner extending along a length of the outer sheath subassembly can have built-in slack to facilitate flexible bending of the outer sheath subassembly.

[0035] FIG. 6 shows a perspective view of a rail subassembly of the delivery device of the delivery system of FIG. 1.

[0036] FIG. 7A shows a side cross-sectional view of the rail subassembly of FIG. 6.

[0037] FIG. 7B shows a perspective view of a rail subassembly.

[0038] FIG. 7C shows a perspective view of a pull wire assembly for the rail subassembly shown in FIG. 7B.

[0039] FIGS. 8 and 9 schematically illustrate how an outer compression coil and pull wire can have a longer length than an inner compression coil and pull wire of the rail subassembly.Attorney Docket No: TMTTMT-23254WO01

[0040] FIG. 10 shows a perspective view of a mid-shaft subassembly of the delivery device of the delivery system of FIG. 1.

[0041] FIG. 11 illustrates a side cross-sectional view of the mid-shaft subassembly of FIG. 10.

[0042] FIG. 12 illustrates a side cross-sectional view of a nose body shaft or subassembly.

[0043] FIG. 13 illustrates a perspective view of the handle of the delivery system shown in FIG. 1.

[0044] FIG. 14 illustrates a side view of the handle of the delivery system shown in FIG.1.

[0045] FIG. 15 illustrates a cross-sectional perspective view of the handle of the delivery system shown in FIG. 1 along a mid-line.

[0046] FIG. 16 illustrates a cross-sectional side view of the handle of the delivery system shown in FIG. 1 along a mid-line.

[0047] FIG. 17 illustrates a schematic view of a device or implant unit and a delivery catheter unit.

[0048] FIG. 18 illustrates a perspective view of a device or implant unit.

[0049] FIG. 19 illustrates a side view of a release tether extending through a plurality of loop portions of a tether assembly.

[0050] FIG. 20 illustrates a plan view of a tether assembly.

[0051] FIG. 21 illustrates a partial cross-sectional view of the tether assembly shown in FIG. 20.

[0052] FIG. 22 illustrates a perspective view of a release assembly.

[0053] FIG. 23 illustrates a cross-sectional view of the release assembly shown in FIG. 22.

[0054] FIG. 24 illustrates a side view of components of an attachment assembly.

[0055] FIG. 25 illustrates a perspective view of a connecting member.

[0056] FIG. 26 illustrates a perspective side view of the connecting member of FIG. 25.

[0057] FIG. 27 illustrates a perspective view of a connector being attached.

[0058] FIG. 28 illustrates a perspective view of the connector of FIG. 27 attached.

[0059] FIG. 29 illustrates a side view of a connecting member.

[0060] FIG. 30 illustrates a side view of the connecting member of FIG. 29 attached to a snare assembly.Attorney Docket No: TMTTMT-23254WO01

[0061] FIG. 31 illustrates a perspective view of a connector being attached.

[0062] FIG. 32 illustrates a perspective view of the connector of FIG. 31 attached.

[0063] FIG. 33 illustrates a side view of a connecting member connected to a snare assembly.

[0064] FIG. 34 illustrates a perspective view of an alignment sheath.

[0065] FIG. 35 illustrates a perspective view of a unit including the alignment sheath ofFIG. 34.

[0066] FIG. 36 illustrates a perspective view of a device or implant including a locking device.

[0067] FIG. 37 illustrates an end view of the locking device of FIG. 36.

[0068] FIG. 38 illustrates a side view of a device or implant unit attached to a delivery catheter.

[0069] FIG. 39 illustrates a perspective view of an adaptor of a delivery catheter.

[0070] FIG. 40 illustrates a perspective view of a connecting member of the adaptor ofFIG. 39.

[0071] FIG. 41 illustrates a perspective view of an actuator assembly.

[0072] FIG. 42 illustrates a front view of the actuator assembly shown in FIG. 41.

[0073] FIG. 43 illustrates a side view of a device or implant being retracted towards a delivery catheter.

[0074] FIG. 44 illustrates a perspective view of the device or implant being drawn towards a distal pusher of a delivery catheter.

[0075] FIG. 45 illustrates a perspective view of the proximal end portion or inflow end portion of the device or implant being retracted into the distal pusher shown in FIG. 44.

[0076] FIG. 46 illustrates a perspective view of an outer sheath extending over a device or implant.

[0077] FIG. 47A illustrates a side view of a proximal end portion of a handle with snare assemblies extending from the handle.

[0078] FIG. 47B illustrates a side cross sectional schematic view of an arrangement of an attachment assembly.

[0079] FIG. 48 illustrates a perspective view of a device or implant coupled to a tether assembly.Attorney Docket No: TMTTMT-23254WO01

[0080] FIG. 49 illustrates a perspective view of a release assembly retracted through a loop portion of a tether assembly.

[0081] FIG. 50 illustrates a perspective view of a release assembly retracted through loop portions of a tether assembly.

[0082] FIG. 51 illustrates a perspective view of a tether assembly released from a device or implant.

[0083] FIG. 52 illustrates a schematic view of a delivery system approaching a treatment or implantation site.

[0084] FIG. 53 illustrates a schematic view of a delivery system approaching a tricuspid valve.

[0085] FIG. 54 illustrates a schematic view of a device or implant being deployed to a tricuspid valve.

[0086] FIG. 55 illustrates a schematic view of a device or implant being deployed to a tricuspid valve.

[0087] FIG. 56 illustrates a schematic view of a tether assembly released from a device or implant.

[0088] FIG. 57 illustrates a side view of a prosthetic valve deployed to a tricuspid valve.

[0089] FIG. 58 illustrates a side view of a connector.

[0090] FIGS. 59 A and 59B illustrate a side view of a connector.

[0091] FIG. 60 illustrates a side view of a connector.

[0092] FIG. 61 illustrates a side view of a connector.

[0093] FIGS. 62A-62C illustrate a perspective view of a connector.

[0094] FIGS. 63 A and 63B illustrate a side view of a connector.

[0095] FIG. 64A illustrates a perspective view of a connector.

[0096] FIG. 64B illustrates a side view of the connector shown in FIG. 64A.

[0097] FIG. 64C illustrates a perspective view of the connector shown in FIG. 64A.

[0098] FIG. 64D illustrates an end cross-sectional view of the connector shown in FIG. 64A.

[0099] FIG. 65A illustrates a perspective view of a connector.

[0100] FIGS. 65B and 65C illustrate a perspective view of a connector.

[0101] FIGS. 65D and 65E illustrate a perspective view of a connector.Attorney Docket No: TMTTMT-23254WO01

[0102] FIG. 66 illustrates a schematic view of a device or implant unit and a delivery catheter unit.

[0103] FIG. 67 A illustrates a side view of components of an attachment assembly.

[0104] FIG. 67B illustrates a side cross sectional schematic view of an arrangement of an attachment assembly.

[0105] FIG. 68A illustrates a side view of a flexible retention tether being drawn from a spool.

[0106] FIG. 68B illustrates a side view of the flexible retention tether of FIG. 68A having been drawn from a spool.

[0107] FIG. 68C illustrates a side view of the flexible retention tether of FIG. 68A engaging with a manifold of a tether assembly.

[0108] FIG. 69A illustrates a side view of a connecting member.

[0109] FIG. 69B illustrates a side view of a connecting member.

[0110] FIG. 70A illustrates a perspective view of a connector.

[0111] FIG. 70B illustrates a side cross sectional view of the connector of FIG. 70A connected.

[0112] FIG. 70C illustrates a side cross sectional view of the connector of FIG. 70A being released.

[0113] FIG. 71A illustrates a side view of a snare assembly.

[0114] FIG. 7 IB illustrates a side view of the snare assembly of FIG. 71 A with the snare assembly closed.

[0115] FIG. 72A illustrates an end cross sectional view of an adaptor.

[0116] FIG. 72B illustrates an end cross sectional view of the adaptor of FIG. 72A engaged with a connecting member.

[0117] FIG. 73 illustrates an end view of an adaptor.

[0118] FIG. 74 illustrates a side schematic view of the adaptor of FIG. 73.

[0119] FIG. 75 illustrates a perspective view of an elongate partition.

[0120] FIG. 76 A illustrates a perspective view of an elongate partition.

[0121] FIG. 76B illustrates an end view of the elongate partition of FIG. 76A.

[0122] FIG. 77A illustrates a side cross sectional view of an elongate partition.Attorney Docket No: TMTTMT-23254WO01

[0123] FIG. 77B illustrates a side cross sectional view of the elongate partition of FIG. 77A.

[0124] FIG. 77C illustrates an end cross sectional view of the elongate partition of FIG. 77A.

[0125] FIG. 77D illustrates a perspective view of an elongate partition.

[0126] FIG. 78A illustrates a side schematic view of an attachment assembly.

[0127] FIG. 78B illustrates a side schematic view of the attachment assembly of FIG. 78 A retracted.

[0128] FIG. 78C illustrates a side schematic view of the attachment assembly of FIG. 78B with a pull tether retracted laterally.

[0129] FIG. 79A illustrates a perspective view of a device or implant.

[0130] FIG. 79B illustrates a perspective view of a connection to a tether assembly for the device or implant shown in FIG. 79A.

[0131] FIG. 79C illustrates a side view of a connection to a tether assembly for the device or implant shown in FIG. 79A.

[0132] FIG. 80A illustrates a perspective view of a tether threading device extending through eyelets of a device or implant.

[0133] FIG. 80B illustrates a perspective view of coupling tethers of a tether assembly extending through eyelets of the device or implant shown in FIG. 80A.

[0134] FIG. 81 illustrates a perspective view of a snare coupling with a loop portion of a coupling tether.

[0135] FIGS. 82A-82C illustrate a side view of a snare assembly extending through eyelets of a device or implant.

[0136] FIG. 83 illustrates a side view of a release tether threading device extending through loop portions of coupling tethers.

[0137] FIGS. 84A-84E each illustrate a side view of an eyelet.

[0138] FIG. 85 illustrates a perspective view of a device or implant.

[0139] FIG. 86 illustrates an outflow end view of a device or implant.

[0140] FIG. 87 illustrates a side cross sectional schematic view of the device or implant shown in FIG. 85.Attorney Docket No: TMTTMT-23254WO01DETAILED DESCRIPTION

[0141] The present specification and drawings provide aspects and features of the disclosure in the context of several examples of devices or implants such as prosthetic valves or replacement heart valves, and delivery systems and methods that are configured for use in the vasculature of a subject (e.g., a living animal, a simulation, etc.), such as for replacement of natural heart valves in a subject. These examples may be discussed in connection with replacing specific valves such as the subject’s aortic, tricuspid, or mitral valve. However, it is to be understood that the features and concepts discussed herein can be applied to products and devices other than heart valve implants. For example, features described herein can be applied to other medical implants, for example other types of prostheses, for use elsewhere in the body, such as within an artery, a vein, or other body cavities or locations. In addition, particular features of a valve, delivery 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 certain 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 or transjugular approaches. Moreover, it should be understood that certain of the features described in connection with some examples can be incorporated with other examples, including those which are described in connection with different delivery approaches.

[0142] FIG. 1 illustrates an example of a delivery system 10. The delivery system 10 can be used to deploy a device or implant as disclosed herein, or another form of device or implant. Features of systems, devices, implants, prosthetic heart valves, etc. that may be utilized are disclosed in International Application No. PCT / US2023 / 085397, with an international filing date of December 21, 2023, and published as WO / 2024 / 145164, and titled “DELIVERY SYSTEMS AND TETHER ASSEMBLIES FOR PROSTHETIC VALVES”; and International Application No. PCT / US2023 / 085391, with an international filing date of December 21, 2023, and published as WO / 2024 / 145160 and titled “PROSTHETIC VALVE”; the entire contents of each of which are hereby incorporated by reference for all purposes.

[0143] A device or implant, such as a prosthetic heart valve, may be delivered to a subject’s mitral or tricuspid 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 subject’s vasculature. Example transfemoral approaches are described further in U.S. Pat. Publ.Attorney Docket No: TMTTMT-23254WO01No. 2015 / 0238315, published August 27, 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 approaches, including delivery systems for a transapical delivery approach.

[0144] In some implementations, the delivery system 10 may be used to deploy a device or prosthesis, such as a replacement heart valve, to a location within the body of a subject. The delivery system 10 may include multiple components, devices, or subassemblies. As shown in FIG. 1, the delivery system 10 may include an elongate catheter, delivery device, or delivery catheter 12, and a stabilizer assembly 14, and other components as desired. The delivery catheter 12 may include a shaft assembly or elongate shaft 18 and a housing in the form of a handle 16. The housing may be at the proximal end portion of the shaft assembly or elongate shaft 18.

[0145] In some implementations, the shaft assembly or elongate shaft 18 includes a distal end portion 19. The elongate shaft 18 can be used to hold the device or implant (e.g., prosthesis, replacement heart valve) for advancement of the same through the vasculature to a treatment location. The elongate shaft 18 may be for advancing the device or implant through a subject’s vasculature to a treatment site or implantation site (e.g., a native atrioventricular valve). In some implementations, the elongate shaft 18 can hold at least a portion of an expandable device or implant (e.g., prosthesis, replacement heart valve) in a compressed state for advancement of the device or implant within the body. The elongate shaft 18 may then be used to allow controlled expansion of the device or implant at a desired treatment or implantation location (e.g. treatment location). In some implementations, the elongate shaft 18 may be used to allow for sequential controlled expansion of the device or implant as discussed in detail below.

[0146] In some implementations, the shaft assembly or elongate shaft 18 of the delivery device 12 can include one or more shafts. In some implementations, a plurality of shafts may be provided. A plurality of shafts may be provided according to examples herein, although in some implementations a single shaft may be utilized. The plurality of shafts may include one or more subassemblies or shafts, such as an outer sheath shaft or subassembly 20, a rail shaft or subassembly 22, a mid shaft or mid shaft subassembly 24, and / or a nose body shaft or subassembly 25. In some implementations, a tether assembly or subassembly may be utilized. In some implementations, a release assembly or subassembly may be utilized. In some implementations,Attorney Docket No: TMTTMT-23254WO01 the elongate shaft 18 of the delivery catheter 12 may not have all of the subassemblies or shafts disclosed herein. The delivery catheter 12 may include multiple layers of concentric shafts, subassemblies, or lumens. The various lumen or shaft subassemblies may be described starting from an outermost layer. In some implementations, the shafts or subassemblies described may be in a different radial order than is discussed.

[0147] FIG. 2 shows a perspective view of an example of the outer sheath shaft or subassembly 20 of the delivery device or delivery catheter 12 of the delivery system 10. The outer sheath shaft or subassembly 20 forms a radially outer covering, or sheath, to cover and surround a device / implant retention area 106 (marked in FIG. 5) for retaining the device or implant, and preventing at least a portion of the device or implant (e.g., replacement heart valve or valve prosthesis) from radially expanding until ready for treatment (e.g., implantation, etc.). Specifically, the outer sheath subassembly 20 can prevent a distal end portion of a device or implant from radially expanding.

[0148] In some implementations, the outer sheath shaft or subassembly 20 can include an outer proximal shaft 30 having a proximal end portion operably coupled (e.g., via threaded outer sheath adaptor 32 at a proximal portion of the outer sheath shaft or subassembly 20) to an actuator assembly including a capsule actuator or knob 34 (which may be a distal-most actuator or knob, as shown in FIGS. 13-16) of the handle 16 such that rotation of the capsule knob 34 causes proximal and distal movement in the form of translation of the outer sheath subassembly 20 (e.g., clockwise and counter-clockwise rotation). A capsule subassembly 36 can be attached to a distal end of the outer proximal shaft 30. The capsule of the capsule subassembly 36 is at the distal end portion of the elongate shaft or shaft assembly 18 and is adapted to maintain the device in a compressed state. The components of the outer sheath shaft or subassembly 20 can form an outermost lumen for the other shafts or subassemblies to pass through.

[0149] In some implementations, the outer proximal shaft 30 may be a tube formed of a plastic, but could also be formed of a metal hypotube or other material. The outer proximal shaft 30 may include an outer jacket or liner made of fluorinated ethylene propylene (FEP) material, polytetrafluoroethylene (PTFE) material, ePTFE material, or other polymeric material so as to make the outer surface of the outer proximal shaft 30 smooth and hemostatic. The outer proximal shaft 30 may include a connector (e.g., flexible reflow member) at its distal end to facilitate connection or coupling to the capsule subassembly 36. At least a portion of the outer proximalAttorney Docket No: TMTTMT-23254WO01 shaft 30 may comprise a laser cut hypotube with a flexible pattern, such as a universally flexible pattern. An interrupted spiral pattern or an interrupted coil may be utilized.

[0150] FIG. 3 shows a side cross-section view of the capsule subassembly 36. The capsule subassembly 36 may include a distal hypotube, or capsule stent 38, an inner liner inside of the hypotube 38, a distal capsule tip 100, and one or more outer liners or jackets 102 surrounding the hypotube 38. The one or more outer liners or jackets 102 may comprise PEBAX or other suitable polymer or thermoplastic elastomer material, such as polytetrafluoroethylene (PTFE) or expanded polytetrafluoroethylene (ePTFE). The inner liner may comprise PTFE, which may be precompressed before application to the inside of the hypotube 38. The distal capsule tip 100 may comprise an atraumatic tip adapted to act as a funnel to facilitate recapture (e.g., crimping) of a valve prosthesis or other device or implant. The distal capsule tip 100 may be comprised of polyetheretherketone (PEEK) or other thermoplastic, polymeric, or metallic material. The distal capsule tip 100 may be loaded with radiopaque material (e.g., 5-40% barium sulfate loading) to facilitate detection (e.g., made Anorogenic) under radiographic imaging (e.g., Auoroscopy). The distal capsule tip 100 may fit within an open distal end of the hypotube 38.

[0151] FIG. 4 shows a perspective view of the distal hypotube, or capsule stent 38. The capsule stent 38 can be formed from one or more materials, such as PTFE, ePTFE, polyether block amide (Pebax®), poly etherimide (Ultem®), PEEK, urethane, Nitinol, stainless steel, and / or any other biocompatible material. The capsule stent 38 is preferably Aexible while still maintaining a sufficient degree of radial strength to maintain a device or implant (e.g., replacement valve, treatment device, repair device, etc.) within the capsule stent 38 without substantial radial deformation, which could increase friction between the capsule stent 38 and a device or implant contained therein. In some implementations, the capsule stent 38 also preferably has sufficient column strength to resist buckling, and sufficient tear resistance to reduce or eliminate the possibility of the device or implant tearing and / or damaging the capsule stent 38. The proximal end and / or distal end of the distal hypotube, or capsule stent 38 may include multiple laser cut windows 104 adapted to make the proximal and / or distal end Anorogenic and / or echogenic to facilitate visualization under certain imaging modalities (e.g., noninvasive ultrasound imaging or invasive Auoroscopic imaging). In several implementations, a separate radiopaque element or member is not added to the hypotube 38 to facilitate imaging because of the presence of the laser cut windows 104. The laser cut windows 104 may also promote adhesion of the outer jacket 102Attorney Docket No: TMTTMT-23254WO01 to the capsule stent 38 and to the inner liner(s) by allowing glue or other adhesive to flow through the laser cut windows 104. One or more layers of connection members made of PEBAX or other suitable material may surround the laser cut windows 104 to facilitate coupling of the hypotube, or capsule stent 38 to the distal capsule tip 100.

[0152] In some implementations, the hypotube 38 may be formed of a plastic or metallic material. In some implementations, the hypotube 38 can be a metal hypotube. If metallic, the metallic material of the hypotube 38 may comprise cobalt chrome, stainless steel, titanium or metal alloy, such as nickel-titanium alloy material. The coil construction or cut patterns of the proximal outer shaft 30 and / or the hypotube 38 can allow the proximal shaft 30 to follow the rail shaft or subassembly 22 in any desired direction. A cut pattern of the proximal outer shaft 30 and / or the hypotube 38 may be modified (e.g., cut per revolution, pitch, spine distance) to control tension resistance, compression resistance, flexibility, and torque resistance. For example, cuts per revolution may range between 1.5 and 5.5, pitch may range between 0.005” and 0.15”, and spine distance may range between 0.015” and 0.125”. The hypotube 38 may advantageously provide both tension and compression. The one or more outer liners or jackets 102 may allow the capsule subassembly 36 to be more flexible. The capsule hypotube 38 can bend in multiple directions. In some implementations, a distal terminus of the outer liner or jacket 102 may be positioned proximal of the distal terminus of the hypotube 38.

[0153] In some implementations, the capsule subassembly 36 may have a similar diameter as the outer proximal shaft 30 or a different diameter. In some implementations, the capsule subassembly 36 has a uniform or substantially uniform diameter along its length. In some implementations, the capsule subassembly 36 can be 28 French or less in size (e.g., 27 French). In some implementations, the capsule subassembly 36 may include a larger diameter distal portion and a smaller diameter proximal portion. In some implementations, the capsule subassembly 36 or capsule can be configured to retain the device or implant (e.g., valve prosthesis, treatment device, etc.) in the compressed position within the capsule subassembly 36 (e.g., within a device / implant retention area 106 marked in FIG. 5 occupying a distal-most 5 cm or inches of the capsule subassembly 36). Additional structural and operation details of a capsule subassembly, such as those described in connection with capsules in U.S. Publication No. 2019 / 0008640 and U.S. Publication No. 2019 / 0008639, which are hereby incorporated by reference herein, may be incorporated into the capsule subassembly 36.Attorney Docket No: TMTTMT-23254WO01

[0154] In some implementations, the outer sheath shaft or subassembly 20 is configured to be individually movable or slidable with respect to the other shafts or assemblies by operation of a control mechanism. The control mechanism may include an actuator assembly including a capsule knob 34 (marked in FIG. 13). The capsule knob 34 may be rotated to move or slide the outer sheath shaft or subassembly 20. Further, the outer sheath subassembly 20 can slide distally and proximally relative to the rail subassembly 22 together with the mid shaft subassembly 24, a tether assembly, a release assembly, and / or nose body subassembly 25. The control mechanism may be configured for controlling deflection of a portion of the delivery device or delivery catheter 12 of the delivery system 10, including a deflectable portion of the delivery device or delivery catheter 12.

[0155] FIG. 5 schematically illustrates how at least a portion of a length of one or more components of the capsule subassembly 36 (e.g., inner liner 108) can include excess material such that the capsule subassembly 36 includes built-in slack along a portion of its length (e.g., a portion of the length proximal to the device or implant retention area 106) to facilitate flexible bending of the capsule subassembly 36 (e.g., to navigate tight turns within a heart or vasculature surrounding the heart).

[0156] FIG. 6 shows a perspective view of a rail shaft or subassembly 22 of the elongate shaft 18 of the delivery catheter 12 of FIG. 1. FIG. 6 shows approximately the same view as FIG. 2, but with the outer sheath subassembly 20 removed, thereby exposing the rail subassembly 22.

[0157] FIG. 7A further shows a cross-section of the proximal and distal end portions of the rail subassembly 22 to view the pull wires or pull tethers that facilitate steering of the rail subassembly 22. The rail subassembly 22 can include a rail shaft 110 (or rail) generally attached (and operably coupled) at its proximal end to the handle 16. The rail shaft 110 can be made up of a rail proximal shaft 112 directly attached to the handle 16 at a proximal end and a rail hypotube 114 attached to the distal end of the rail proximal shaft 112 (e.g., via a connector, ring-like structure, or insert 116).

[0158] In some implementations, the rail subassembly 22 is operably coupled to the handle 16 via primary flex adaptor 118A at a proximal portion of the rail subassembly 22 (which controls medial-lateral trajectory of the distal end portion of the rail subassembly 22 via one or more distal pull tethers or wires 120A (marked in FIG. 7A), via secondary flex adaptor 118B at a proximal portion of the rail subassembly 22 (which controls anterior-posterior trajectory of the distal endAttorney Docket No: TMTTMT-23254WO01 portion of the rail subassembly 22 via one or more proximal pull tethers or wires 120B), and via rail adaptor 119 at a proximal portion of the rail subassembly 22 (which includes a side nccdlclcss injection port to facilitate flushing and de-airing functions)).

[0159] In some implementations, the rail proximal shaft 112 may include an interrupted spiral cut pattern along a large portion of its length to facilitate compression.

[0160] In some implementations, the rail hypotube 114 can further include an atraumatic rail tip 122 at its distal tip. The atraumatic rail tip 122 may not comprise slits and is configured to extend up to 1 inch beyond the distal terminus of the rail hypotube 114 and is configured not to dig into the outer shaft subassembly 20 to avoid friction and fatigue and to prolong use. These components of the rail subassembly 22 can form a lumen for the other inner subassemblies to pass through.

[0161] FIG. 7A shows a side cross-section view of the rail shaft or subassembly 22 of FIG. 6. As shown in FIG. 7 A, attached to an inner surface of the rail hypotube 114 are one or more pull wires 120 which can be used apply forces to the rail hypotube 114 and steer the rail subassembly 22. The pull wires 120 can extend distally from the primary and secondary flex knobs 124A, B (illustrated in FIGS. 13 and 14) in the handle 16 to the rail hypotube 114. In some implementations, pull wires 120 can be attached at different longitudinal locations on the rail hypotube 114, thus providing for multiple bending locations in the rail hypotube 114, allowing for multidimensional steering. For example, the rail hypotube 114 may provide a primary bend or flex along a medial / lateral trajectory and a secondary bend or flex along an anterior / posterior trajectory. Alternative directions of bend may be provided for deployment to a tricuspid valve. The rail hypotube 114 may form a bend portion for bending other of the shafts of the elongate shaft 18.

[0162] In some implementations, the rail hypotube 114 may include a number of circumferential slots (e.g., laser cut into the hypotube) to facilitate bending and flexibility. The rail hypotube 114 can generally be broken into a number of different sections. At the most proximal end is an uncut (or unslotted) hypotube section corresponding to the location of insert 116. Moving distally, the next section is the proximal slotted hypotube section 126P. This section includes a number of circumferential slots cut into the rail hypotube 114. Generally, two slots are cut around each circumferential location forming almost half of the circumference. Accordingly, two backbones are formed between the slots extending up the length of the rail hypotube 114. ThisAttorney Docket No: TMTTMT-23254WO01 is the section that can be guided by the proximal pull wire(s) 120B. Moving further distally is the location where the proximal pull wires 120 connect, and thus slots can be avoided. This section is just distal of the proximally slotted section 126P and may correspond to the location of insert, or pull wire connector 128.

[0163] Distally following the proximal pull wire connection area is the distal slotted hypotube section 126D. This section is similar to the proximal slotted hypotube section 126P, but may have significantly more slots cut out in an equivalent length. Thus, the distal slotted hypotube section 126D may provide easier bending and an increased bend angle than the proximal slotted hypotube section 126P. In some implementations, the proximal slotted section 126P can be configured to experience a bend of approximately 90 degrees with a half inch radius whereas the distal slotted section 126D can bend at approximately 180 degrees with a half inch radius. Further, as shown in FIGS. 6 and 7A, the spines of the distally slotted hypotube section 126D are circumferentially offset from the spines of the proximal slotted hypotube section 126P. Accordingly, the two sections will achieve different bend patterns, allowing for three-dimensional steering of the rail subassembly 22. In some implementations, the spines can be offset 30, 45, or 90 degrees, though the particular’ offset is not limiting. At the distal-most end of the distal slotted hypotube section 126D is the distal pull wire connection area which is again a non-slotted section of the rail hypotube 114.

[0164] In some implementations, one distal pull wire 120A can extend to a distal section (e.g., to rail tip 122) of the rail hypotube 114 and two proximal pull wires 120B can extend to a proximal section of the rail hypotube 114; however, other numbers of pull wires can be used, and the particular amount of pull wires is not limiting. For example, two distal pull wires 120A can extend to a distal location and a single proximal pull wire 120B can extend to a proximal location. In some implementations, ring-like structures or inserts attached inside the rail hypotube 114, known as pull wire connectors, can be used as attachment locations for the proximal pull wires 120B, such as insert 128. In some implementations, the pull wires 120 can directly connect to an inner surface of the rail hypotube 114.

[0165] In some implementations, the distal pull wire(s) 120A can be connected (either on its own or through rail tip connector 122) generally at the distal end of the rail hypotube 114. The proximal pull wire(s) 120B can connect (either on their own or through the insert 128) at a location approximately one quarter, one third, or one half of the length up the rail hypotube 114 from theAttorney Docket No: TMTTMT-23254WO01 proximal end. Tn some implementations, the distal pull wire(s) 120A can pass through a small diameter pull wire lumen (e.g., tube, hypotubc, cylinder) attached on the inside of the rail hypotubc 114. This can prevent the pull wires 120 from pulling on the rail hypotube 114 at a location proximal to the distal connection. Further, the lumen can comprise compression coils to strengthen the proximal portion of the rail hypotube 114 and prevent unwanted bending. Thus, in some implementations the lumen is only located on a proximal portion (e.g., proximal half) of the rail hypotube 114.

[0166] In some implementations, multiple lumens, such as spaced longitudinally apart or adjacent, can be used per distal pull wire 120A. In some implementations, a single lumen is used per distal wire 120A. In some implementations, the lumen can extend into the distal portion (e.g., distal half) of the rail hypotube 114. In some implementations, the lumen is attached on an outer surface of the rail hypotube 114. In some implementations, the lumen is not used.

[0167] In some implementations, one or more compression coils 130 extend from the insert 116 to the insert 128. In some implementations, the compression coils 130 may be configured to bypass load in length between a distal primary flex point and a proximal secondary flex point. The compression coils 130 facilitate independent flex planes so that both planes of flex do not activate when one plane of flex is desired to Hex. The compression coils 130 may allow for the proximal slotted hypotube section 126P to retain rigidity for specific bending of the distal slotted hypotube section 126D. The compression coils 130 may isolate force so only the primary flex is flexed.

[0168] For the pair of proximal pull wires 120B, the wires can be spaced approximately 180° from one another to allow for steering in both directions. Similarly, if a pair of distal pull wires 120A is used, the wires can be spaced approximately 180° from one another to allow for steering in both directions. In some implementations, the pair of distal pull wires 120A and the pair of proximal pull wires 120B can be spaced approximately 90° from each other. Opposing wires could be used to provide anti-flex mechanism. In some implementations, the pair of distal pull wires 120A and the pair of proximal pull wires 120B can be spaced approximately 0° from each other. However, other locations for the pull wires can be used as well, and the particular location of the pull wires is not limiting. In some implementations, the distal pull wire 120A can pass through a lumen attached within the lumen of the rail hypotube 114. This can prevent an axial force on the distal pull wire 120A from creating a bend in a proximal section of the rail hypotube 114.Attorney Docket No: TMTTMT-23254WO01

[0169] In some implementations, the rail subassembly 22 is disposed so as to be slidable over the radially inner subassemblies. In some implementations, as the rail hypotubc 114 is bent, it presses against the other subassemblies to bend them as well, and thus the other subassemblies of the delivery catheter 12 can be configured to steer along with the rail subassembly 22 as a cooperating single unit, thus providing for full steerability of the distal end of the delivery catheter 12. In some implementations, the rail hypotube 114 is adapted to bend in a first direction in a first plane (the plane of deflection of the distal slotted hypotube section 126D) and in a second direction in a second plane (the plane of deflection of the proximally slotted hypotube section 126P), with the second plane extending transverse or perpendicular relative to the first plane. Additional structural and operation details of a rail subassembly, such as those described in connection with rail assemblies in U.S. Publication No. 2019 / 0008640 and U.S. Publication No. 2019 / 0008639, which are hereby incorporated by reference herein, may be incorporated into the rail subassembly 22.

[0170] In some implementations, additional directions of flex, bending, or deflection of a rail subassembly. FIG. 7B, for example, illustrates a variation of a rail subassembly 131 including a distally slotted hypotube section 133, an intermediate slotted hypotube section 135, and a proximal slotted hypotube section 137. The distally slotted hypotube section 133 may be adapted for producing deflection in a first plane in a first direction. The intermediate slotted hypotube section 135 may be adapted for producing deflection in a second plane that is transverse to the first plane. The second plane may be perpendicular to the first plane in some implementations. The proximal slotted hypotube section 137 may be adapted to produce deflection in the first plane, in a third direction that is opposite the first direction. As such, the proximal slotted hypotube section 137 may be adapted to produce height opposite the first direction in some implementations. Features of such configurations to produce height that may be utilized herein are disclosed in International Application No. PCT / US2023 / 085397, with an international filing date of December 21, 2023, and published as WO / 2024 / 145164, and titled “DELIVERY SYSTEMS AND TETHER ASSEMBLIES FOR PROSTHETIC VALVES,” the entire contents of which are incorporated by reference herein.

[0171] FIG. 7C illustrates respective pull wire assemblies 129, 123, 127 that may be utilized to actuate the respective hypotube sections 133, 135, 137.Attorney Docket No: TMTTMT-23254WO01

[0172] FIGS. 8 and 9 schematically illustrate how an outer compression coil 130A and proximal pull wire 120B1 can have a longer length than an inner compression coil 130B and proximal pull wire 120B2 of the rail subassembly 22 so that they don’t occupy the same space and to facilitate ease of bending in one direction and reduce lumen obstruction during bending.

[0173] Moving radially inwardly, the next subassembly is the mid shaft or mid shaft subassembly 24. FIG. 10 shows a perspective view of the mid-shaft subassembly 24 of the delivery catheter 12 of the delivery system 10. FIG. 11 illustrates a side view. The mid-shaft subassembly 24 can include a distal mid-shaft hypotube 132 generally attached at its proximal end to a proximal shaft 134, which in turn can be attached at its proximal end to the handle 16 (e.g., via mid-shaft adaptor 136 at a proximal portion of the mid-shaft subassembly 24), and a distal pusher 138 located at the distal end of the mid-shaft hypotube 132. These components of the mid-shaft subassembly 24 can form a lumen for other inner subassemblies to pass through.

[0174] In some implementations, the mid-shaft subassembly 24 can be located within a lumen of the rail subassembly 22. The mid-shaft hypotube 132 can be formed of metallic alloy (e.g., cobalt chrome, nickel-chromium-cobalt alloy, nickel-cobalt base alloy, nickel-titanium alloy, stainless steel, and titanium). The mid-shaft hypotube 132 may comprise an interrupted spiral cut pattern. FIG. 10 shows a similar view as FIG. 6, but with the rail subassembly 22 removed, thereby exposing the mid-shaft subassembly 24.

[0175] Similar to the other subassemblies, the mid-shaft hypotube 132 and / or mid-shaft proximal tube 134 can comprise a tube, such as a hypodermic tube or hypotube (not shown). The tubes can be made from one of any number of different materials including Nitinol, stainless steel, and medical grade plastics. The tubes can be a single piece tube or multiple pieces connected together. Using a tube made of multiple pieces can allow the tube to provide different characteristics along different sections of the tube, such as rigidity and flexibility. The mid- shaft hypotube 132 can be a metal hypotube. The mid-shaft hypotube 132 can have a number of slots / apertures cut into the hypotube. In some implementations, the cut pattern can be the same throughout. In some implementations, the mid shaft hypotube 132 can have different sections having different cut patterns. The mid-shaft hypotube 132 can be covered or encapsulated with a layer of ePTFE, PTFE, or other material so that the outer surface of the mid- shaft hypotube 132 is generally smooth. At least a portion of a length of the mid-shaft proximal tube 134 may be covered with a heat shrink tubing or wrap.Attorney Docket No: TMTTMT-23254WO01

[0176] In some implementations, the pusher 138 may be configured for radially retaining a portion of the device or implant (c.g., prosthesis, valve, treatment device, repair device, etc.) in a compacted configuration, such as a proximal end of the device or implant. The pusher 138 may compress an inlet end portion of the device or prosthetic heart valve. For example, the pusher 138 may be a ring or covering that is configured to radially cover the proximal end portion (e.g., suture eyelets portion) of the device or implant. The pusher 138 can also be considered to be pail of the device or implant retention area 106, and may be at the proximal end of the device or implant retention area 106. In some implementations, the pusher 138 may comprise a frustoconical or cup shape that is riveted or fastened on its opposite sides to the distal end of the mid-shaft hypotube 132. In some implementations, the pusher 138 may be formed of PEEK material, ferrous material, platinum iridium, or other Anorogenic material to facilitate radiographic imaging.

[0177] In some implementations, the mid-shaft subassembly 24 may be disposed so as to be fixed with respect to the handle. In some implementations, the mid-shaft subassembly 24 may be individually slidable with respect to the other subassemblies. Additional structural and operational details of a mid-shaft subassembly 24, such as those described in connection with mid assemblies in U.S. Publication No. 2019 / 0008640 and U.S. Publication No. 2019 / 0008639, which are hereby incorporated by reference herein, may be incorporated into the mid-shaft subassembly 24.

[0178] FIG. 12 illustrates a side cross sectional view of a nose body shaft or subassembly 25 that may be utilized in some implementations herein. The nose body subassembly 25 may be the most radially inward subassembly and may include a nose body shaft 27 having a distal end connected to a nose body 29. The nose body shaft 27 may have an interior lumen 31 that may be configured for receiving a guide wire therethrough. A nose body shaft adaptor 33 may be positioned at a proximal end of the nose body shaft 27 for engaging with an actuator assembly for the nose body shaft or subassembly 25.

[0179] FIG. 13 shows a perspective view of the housing or handle 16 of the delivery catheter 12. FIG. 14 shows a side view of the handle 16.

[0180] In some implementations, the handle 16 comprises a housing that may include a delivery housing or first housing 139 and a rail housing or second housing 141. The second housing 141 may be coupled to the rail shaft or subassembly 22. A rail adaptor 119 as shown in FIGS. 6 and 7A, for example, may be coupled to the second housing 141 in a fixed position. TheAttorney Docket No: TMTTMT-23254WO01 rail adaptor 119 may move with the second housing 141 to accordingly move the rail shaft or subassembly 22.

[0181] In some implementations, the first housing 139 may be coupled to one or more shafts that are adapted to slide relative to the rail shaft or subassembly 22 to vary a depth of such shafts relative to the rail shaft or subassembly 22. The mid-shaft adaptor 136 (shown in the cross- sectional views of FIGS. 15 and 16) may be fixed in position relative to the first housing 139. The mid-shaft adaptor 136 may move with the first housing 139 to move the mid shaft or mid shaft subassembly 24. The first housing 139 may include a distal portion 143 and a proximal portion 145, with the second housing 141 extending intermediate the distal portion 143 and proximal portion 145 and around the first housing 139 at an intermediate portion of the first housing 139 (as shown in the cross-sectional view of FIG. 16).

[0182] In some implementations, the handle 16 includes a control mechanism for moving the one or more shafts of the elongate catheter. The control mechanism may include multiple actuators or actuator assemblies, such as rotatable knobs, that can manipulate different components (e.g., cause movement of respective shafts or subassemblies of the elongate shaft 18) of the delivery system 10.

[0183] In some implementations, the distal end of the handle 16 includes an actuator assembly including a capsule knob 34. Rotation of the capsule knob 34 in one direction may cause proximal movement of the outer sheath subassembly 20 in an axial direction so as to unsheathe and deploy a distal portion (e.g., ventricular portion) of the device or implant from the capsule subassembly 36. The capsule knob 34, for example, may comprise a retraction mechanism for retracting the capsule or capsule subassembly 36 to release the device or implant from the capsule. Rotation of the capsule knob 34 in the opposite direction causes distal movement of the outer sheath subassembly 20 (including the capsule subassembly 36) so as to recapture, retrieve, or resheath, the device or implant within the capsule subassembly 36. The outer sheath subassembly 20 may be individually translated with respect to the other subassemblies in the delivery catheter 12. The distal end of the device or implant can be released first, while the proximal end of the device or implant can remain radially compressed within the pusher 138 of the mid-shaft subassembly 24.

[0184] Referring to the cross-sectional view of FIG. 16, the actuator assembly for the outer sheath subassembly 20 may include the capsule knob 34 and an adaptor 32 (shown in FIG. 2). TheAttorney Docket No: TMTTMT-23254WO01 adaptor 32 may be fixedly coupled to the proximal end of the outer proximal shaft 30. The adaptor 32 may be threaded, and have a threaded engagement with an inner surface of the capsule knob 34. As such, rotation of the capsule knob 34 may produce a longitudinal movement of the adaptor 32 for corresponding proximal or distal axial movement of the outer sheath subassembly 20 (including the capsule subassembly 36). Other forms of actuator assemblies may be utilized in some implementations.

[0185] Moving proximally and referring to FIG. 14, the handle 16 includes a stabilizer mounting area 201 adapted to interface with a clamp of the stabilizer assembly 14 (marked in FIG. 1) configured to control the medial I lateral position of the delivery device 12.

[0186] Moving further proximally are the actuator assemblies comprising primary flex rail knob 124A and the secondary flex rail knob 124B. Rotation of the primary flex rail knob 124A causes flexing of the primary flex portion, or distal slotted hypotube section 126D (marked in FIG. 6) of the rail hypotube 114 to effect changes in medial / lateral trajectory. Rotation of the secondary flex rail knob 124B causes flexing of the primary flex portion, or proximal slotted hypotube section 126P (marked in FIG. 6) of the rail hypotube 114 to effect changes in anterior / posterior trajectory. However, the number of flex rail knobs 124A, B can vary depending on the number of pull wires used.

[0187] Referring to the cross-sectional view of FIG. 16, the actuator assemblies for each of the primary flex rail knob 124 A and the secondary flex rail knob 124B may include the respective knobs 124A, 124B and adaptors 125A, B. The adaptors 125A, B may be fixedly coupled to the proximal ends of the respective pull wires 120A, 120B. The adaptors 125A, B may be configured to move longitudinally with the respective rail knobs 124A, 124B to actuate the respective pull wires 120A, 120B. The elongate shaft 18 accordingly may be steerable in one or more planes. Other forms of actuator assemblies may be utilized in some implementations.

[0188] Proximal to the secondary flex rail knob 124B is the actuator assembly in the form of a depth knob 140 that controls movement of the outer sheath subassembly 20, the mid- shaft subassembly 24, and the nose cone shaft or subassembly 25 relative to the rail subassembly 22. The depth knob 140 may further control movement of the tether assemblies and release assemblies as disclosed herein relative to the rail subassembly 22 in some configurations.

[0189] In some implementations, the depth knob 140 may operate by being coupled to the second housing 141 and in threaded engagement with the first housing 139. The depth knob 140Attorney Docket No: TMTTMT-23254WO01 may be fixed in axial position relative to the second housing 1 1 . Rotation of the depth knob 140 relative to the second housing 141 longitudinally drives the first housing 139 proximally or distally due to the threaded engagement with the first housing 139. As such, the shafts, sheaths, or subassemblies coupled to the first housing 139 move longitudinally along with the first housing 139 and relative to the rail subassembly 22 (and the second housing 141). Such movement may produce depth of the shafts, sheaths, or subassemblies relative to the rail subassembly 22. Such movement may further produce height of the elongate shaft 18 (for example, for a configuration of a rail subassembly as shown in FIG. 7B.).

[0190] Features of such movements that may be utilized herein (e.g., depth and / or height) are disclosed in International Application No. PCT / US2023 / 085397, with an international filing date of December 21, 2023, and published as WO / 2024 / 145164, and titled “DELIVERY SYSTEMS AND TETHER ASSEMBLIES FOR PROSTHETIC VALVES,” the entire contents of which are incorporated by reference herein. The depth or height may be relative to a bent or deflected rail subassembly 22 in some implementations, with the other shafts, sheaths, or subassemblies sliding relative to such a bend in the rail subassembly 22.

[0191] Further proximal to the depth knob 140 may comprise an actuator assembly 147 for a tether assembly for a device or implant. The actuator assembly 147 may include a rotatable knob 151 and an adaptor 153. The rotatable knob 151 may have a threaded engagement with an outer surface of the first housing 139 such that rotation of the rotatable knob 151 longitudinally moves the rotatable knob 151 along the first housing 139. The adaptor 153 may be coupled to the rotatable knob 151 such that rotation of the rotatable knob 151 produces a corresponding longitudinal movement of the adaptor 153. As such, the tether assembly for the device or implant may be retracted or advanced as desired through operation of the actuator assembly 147. The actuator assembly 147 may accordingly control release of the device or implant from the elongate shaft 18.

[0192] Further proximal to the actuator assembly 147 may comprise an actuator assembly 155 for a release tether for the device or implant. The actuator assembly 155 may include a rotatable knob 157 that is coupled to a spool adaptor 159 (shown in the cross-sectional views of FIGS. 15 and 16) for retaining a portion of a release tether assembly. The rotatable knob 157 may rotate to correspondingly rotate the spool adaptor 159 to retract the release tether assembly as desired. The actuator assembly 155 controls actuation of a release assembly for the device or implant.Attorney Docket No: TMTTMT-23254WO01

[0193] Further proximal to the actuator assembly 155 is the actuator assembly 161 for the nose body shaft or subassembly 25, rotation of which causes proximal and distal movement of the nose body shaft or subassembly 25.

[0194] Other configurations of components of the delivery catheter 12 may be utilized in some implementations.

[0195] In some implementations, the tether assemblies as disclosed herein may be utilized for coupling to at least a portion of a device or implant. The tether assemblies may be coupled to at least a portion of the device or implant and may attach to the delivery catheter 12. An issue may arise as to how to couple the tether assemblies to the device or implant and also have the tether assemblies couple to the delivery catheter 12.

[0196] FIG. 17 illustrates a view of a unit 160 or device / implant unit that may be utilized in some implementations herein. The unit 160 may comprise a device or implant 162 (shown in the form of a prosthetic heart valve) and a tether assembly 164 coupled to at least a portion of the device or implant 162. The tether assembly 164 is adapted to be attached to the delivery catheter 12. Methods of attachment are disclosed herein.

[0197] In some implementations, the unit 160 may comprise a body that is separate from the delivery catheter 12. The unit 160 may be provided unattached to the delivery catheter 12. The unit 160 may be modular and movable relative to the delivery catheter 12. In some implementations, the unit 160 may include packaging 166 (represented with the dashed line in FIG. 17) that is separate from the delivery catheter 12. The packaging 166 may comprise a sealed packaging for maintaining the sterility and desired functional properties of the device or implant 162 (e.g., material properties or structural properties). The packaging 166 may protect the contents within the packaging 166. The packaging 166 may be configured for transport and / or storage of the unit 160 separate from the delivery catheter 12 in some implementations.

[0198] In some implementations, the unit 160 may be provided with the tether assembly 164 pre-attached to the device or implant 162 as part of the unit 160 or within the packaging 166. FIG. 18, for example, illustrates a close-up perspective view of the unit 160. The tether assembly 164 is coupled to the device or implant 162 and particularly to the proximal end portion or inlet end portion of the device or implant 162. The device or implant 162 includes a frame having eyelets 165 (with eyelets 165a, b, c marked in the close-up view of FIG. 19 for example), and theAttorney Docket No: TMTTMT-23254WO01 tether assembly 164 may couple to the eyelets 165. The tether assembly 164 may extend through the eyelets 165 in some implementations.

[0199] In some implementations, the tether assembly 164 may include a plurality of coupling tethers 168 (with coupling tethers 168a, b, c marked in FIG. 18). The tether assembly 164 may include a manifold 170 that joins the plurality of coupling tethers 168. Each coupling tether 168 may include a loop portion 172 (with loop portions 172a, b, c marked in FIG. 19) for passing through a respective one of the eyelets 165. The manifold 170 may couple to a first section 174 of a flexible retention tether 175 (marked in FIG. 24) for controlling release of the device or implant 162 from the elongate shaft 18 of the delivery catheter 12.

[0200] FIG. 20 illustrates a side schematic view of the tether assembly 164. The plurality of coupling tethers 168 may each have the loop portion 172 at a distal end portion of the respective coupling tether 168. The proximal end portions 176 of the plurality of coupling tethers 168 may be joined at the manifold 170.

[0201] As shown in FIGS. 20 and 21, the manifold 170 may comprise a sheath 178 (shown in cross sectional view in FIG. 21) and a loop 180 for the proximal end portion 176 of the coupling tethers 168 to extend around. The proximal end portions 176 of the coupling tethers 168 may iteratively loop around the loop 180 to form a desired number of coupling tethers 168 (e.g., nine coupling tethers 168 as represented in FIG. 21). Other methods may be utilized to form the coupling tethers 168 in some implementations. In some implementations, a greater or lesser number of coupling tethers 168 may be utilized as desired.

[0202] In some implementations, the sheath 178 may comprise a shrink tube or other form of sheath 178 (e.g., reflowed material) that may join the proximal end portions 176 of the coupling tethers 168 together.

[0203] In some implementations, the loop 180 may comprise a coupling between the manifold 170 and the first section 174 of the flexible retention tether. The loop 180 may comprise a wire loop that is crimped or otherwise connected to a tube 182 of the first section 174 of the flexible retention tether. The first section 174 of the flexible retention tether may include a distal end portion 184 that couples to the manifold 170 and a proximal end portion 186 may include a connecting member 188 for a connector. The first section 174 of the flexible retention tether may be adapted to extend within an interior lumen of the delivery catheter 12, and may extend towards the actuator assembly 147 for the tether assembly 164.Attorney Docket No: TMTTMT-23254WO01

[0204] Other configurations of tether assemblies may be utilized in some implementations herein. Features of tether assemblies disclosed in International Application No. PCT / US2023 / 085397, with an international filing date of December 21, 2023, and published as WO / 2024 / 145164, and titled “DELIVERY SYSTEMS AND TETHER ASSEMBLIES FOR PROSTHETIC VALVES,” the entire contents of which are incorporated herein, may be utilized as desired.

[0205] In some implementations, the coupling tethers 168 may be made of a flexible material and may comprise sutures or may have another construction in some implementations. The coupling tethers 168 may comprise wires or filaments in some implementations.

[0206] In some implementations, the first section 174 of the flexible retention tether may be made of a material that is relatively stiffer than the material of the coupling tethers 168. The first section 174 may comprise a wire or a tube in some implementations, which may allow for an axially distal pushing force as well as an axially proximal retraction force. The axial movement of the flexible retention tether may be utilized to control release of the device or implant from the delivery catheter 12. Other configurations may be utilized in some implementations.

[0207] Referring to FIG. 18, in some implementations, the unit 160 may include a release assembly 190. The release assembly 190 may be adapted to secure the tether assembly 164 to at least the portion of the device or implant 162. The release assembly 190 may be pre-attached to the tether assembly 164 in some implementations, as part of the unit 160.

[0208] In some implementations, the release assembly 190 may include one or more release tethers 192 (with release tethers 192a, b, c marked in FIG. 18). The release tethers 192 may extend through the loop portions 172 (shown in the close-up view of FIG. 19) to secure the tether assembly 164 to the device or implant 162.

[0209] FIG. 22 illustrates a side view of the release assembly 190. A plurality of release tethers 192 are illustrated (three release tethers 192a, b, c), although a single release tether or a different number of release tethers (e.g., two tethers, four tethers, more than four tethers), may be utilized as desired. The distal end portions 194 of the release tethers 192 may comprise free ends of the release tethers 192. The proximal end portions 196 of the release tethers 192 may couple to a manifold 198 that joins the release tethers 192.Attorney Docket No: TMTTMT-23254WO01

[0210] In some implementations, the manifold 198 may comprise a shrink tube or other form of sheath (e.g., reflowed material) that may join the proximal end portions 196 of the release tethers 192 together. FIG. 23, for example, illustrates a cross-sectional view of the manifold 198.

[0211] In some implementations, the manifold 198 may have a proximal end portion that is coupled to a first section 200 of a retractable tether 203 (marked in FIG. 24). A distal end portion of the first section 200 may couple to the manifold 198 and a proximal end portion 202 may couple to a connecting member 204 for a connector.

[0212] FIG. 23 illustrates a cross-sectional view of the release assembly 190. The proximal ends of the release tethers 192a, c are shown joined in the manifold 198. The release tether 192b is shown to pass through the manifold 198 to form the first section 200 of the retractable tether. Other configurations may be utilized in some implementations. Features of release assemblies disclosed in International Application No. PCT / US2023 / 085397, with an international filing date of December 21, 2023, and published as WO / 2024 / 145164, and titled “DELIVERY SYSTEMS AND TETHER ASSEMBLIES FOR PROSTHETIC VALVES,” the entire contents of which are incorporated herein, may be utilized as desired.

[0213] Referring to FIG. 19, a single release tether 192 may extend through multiple loop portions 172 to secure the tether assembly 164 to the device or implant 162. For example, as shown in FIG. 19, a single release tether 192a may pass through three loop portions 172a, b, c that have been passed through the respective eyelets 165a, b, c. The release tether 192a may hold the loop portions 172a, b, c in place so that they cannot be retracted out from the eyelets 165a, b, c. The release tether 192a may be retracted and withdrawn from the loop portions 172a, b, c in a process as represented in FIGS. 49 and 50 to release the loop portions 172a, b, c from the eyelets 165a, b, c. Each release tether 192a, b, c may extend through a respective set of three loop portions (e.g., a third of the loop portions). Other configurations may be utilized in some implementations. For example, a single release tether 192 may extend through all of the loop portions in some implementations, or other configurations may be utilized (e.g., two release tethers 192 respectively extending through half of the loop portions, or four release tethers each extending through a quarter of the loop portions, among other configurations).

[0214] In some implementations, the release tethers 192 may be made of a flexible material and may comprise sutures or may have another construction in some implementations. The release tethers 192 may comprise wires or filaments in some implementations. The first section 200 ofAttorney Docket No: TMTTMT-23254WO01 the retractable tether may be made of a similar material and may be flexible in some implementations. Other configurations may be utilized in some implementations.

[0215] Referring to FIG. 17, the unit 160 is to be attached to the delivery catheter 12 so that the device or implant 162 may be deployed by the delivery catheter 12 to a treatment or implantation site. The tether assembly 164 and the release assembly 190 comprise a portion of an attachment assembly utilized to attach the unit 160 to the delivery catheter 12. Referring to FIG. 24, features of the attachment assembly are illustrated, including the tether assembly 164, the release assembly 190, a second section 206 of the flexible retention tether 175, a snare assembly 208 for the flexible retention tether 175, a second section 210 of the retractable tether 203, and a snare assembly 212 for the retractable tether 203.

[0216] In some implementations, a connector 214 (marked in FIG. 28) is provided to connect the proximal end portion 186 of the first section 174 of the flexible retention tether 175 with the distal end portion 216 of the second section 206 of the flexible retention tether 175. The connector 214 may include the connecting member 188 and a connecting member 218 (marked in FIG. 25) at the distal end portion 216 of the second section 206 of the flexible retention tether 175.

[0217] In some implementations, the second section 206 of the flexible retention tether 175 may further include a connecting member 220 (marked in FIG. 29) at a proximal end portion 222 of the second section 206. The connecting member 220 may be adapted for coupling with the snare assembly 208.

[0218] In some implementations, the second section 206 of the flexible retention tether 175 may have a similar construction as the first section 174 of the flexible retention tether 175. The second section 206 may comprise a wire or a tube in some implementations, which may allow for an axially distal pushing force as well as an axially proximal retraction force. The second section 206 may have an axial stiffness to transmit an axially distal force to the tether assembly 164 and an axially proximal force to the tether assembly 164. The axial movement of the flexible retention tether 175 may be utilized to control release of the device or implant from the delivery catheter 12. Other configurations may be utilized in some implementations.

[0219] FIG. 25 illustrates a perspective view of the connecting member 218 at the distal end portion 216 of the second section 206 of the flexible retention tether 175. FIG. 27 illustrates a perspective view of the connecting member 188 at the proximal end portion 186 of the firstAttorney Docket No: TMTTMT-23254WO01 section 174 of the flexible retention tether 175. The connecting member 188 is shown to comprise a loop in FIG. 27.

[0220] Referring to FIG. 25, the connecting member 218 includes a receiver portion 224 for receiving the connecting member 188. The receiver portion 224 may include an opening 226 for the connecting member 188 to insert into at the distal end portion of the connecting member 218. The opening 226 may extend to a cavity 228 for receiving the connecting member 188. The receiver portion 224 may include a protrusion 230 for the connecting member 188 to loop around. The protrusion 230 may prevent the connecting member 188 from being withdrawn from the receiver portion 224. In some implementations, the protrusion 230 may have an angled or ramped surface 232 such that the connecting member 188 may pass over the ramped surface 232, with a vertical side wall 234 preventing retraction of the connecting member 188. Further, the receiver portion 224 may include a side wall 236 opposite the side wall 234 of the protrusion 230, to prevent proximal movement or further insertion of the connecting member 188 within the receiver portion 224. The connecting member 188 accordingly may be locked in position between the side wall 234 of the protrusion 230 and the side wall 236 of the receiver portion 224.

[0221] The connecting member 188 being inserted through the opening 226 is represented in FIG. 27. The connecting member 188 locked in position between the protrusion 230 and the side wall 236 is represented in FIG. 28.

[0222] Referring to FIG. 25, a proximal end portion 238 of the connecting member 218 may include a hinge 240 for coupling with the body of the second section 206 of the flexible retention tether 175. The hinge 240 may be adapted for the connecting member 218 to pivot about a loop 242 (marked in FIG. 27) positioned at the distal end portion of the second section 206. The hinge 240 may provide for flexibility between the connection of the connecting member 218 and the loop 242.

[0223] In some implementations, the connector 214 (marked in FIG. 28) may comprise a mechanical snap connector, in which a user inserts the connecting member 188 into the receiver portion 224 for connection between the connecting members 188, 218. The connector 214 may comprise a quick-connect device. The connector 214 is adapted to transmit an axially proximal force to the tether assembly 164 via the contact between the connecting member 188 and the side wall 234. The connector 214 is adapted to transmit an axially distal force to the tether assembly 164 via the contact between the connecting member 188 and the side wall 236. As such, bothAttorney Docket No: TMTTMT-23254WO01 proximal and distal forces may be transmitted via the connector 214. The hinge 240 may provide for flexibility at the connector 214.

[0224] In some implementations, the configuration of the connector 214 may be varied. For example, the relationship of the connecting member 188 and the connecting member 218 may be alternated in which the proximal end portion of the first section 174 of the flexible retention tether 175 includes the connecting member 218 (and the distal end portion of the second section 206 includes the connecting member 188). Other forms of connectors may be utilized as desired.

[0225] FIG. 29 illustrates a side view of the connecting member 220 at the proximal end portion 222 of the second section 206 of the flexible retention tether 175. The connecting member 220 may be adapted to connect to the snare assembly 208 (marked in FIG. 30) for the flexible retention tether 175. The connecting member 220 may comprise a hook for hooking a loop comprising the connecting member 244 for the snare assembly 208. An end of the connecting member 220 may have a tapered shape.

[0226] In some implementations, the snare assembly 208 may comprise an elongate body including a loop of material (e.g., suture or wire) for engaging the second section 206 of the flexible retention tether 175. The snare assembly 208 may have other configurations in some implementations. Referring to FIG. 24, a proximal end portion 246 of the snare assembly 208 may include a grasping portion 248 for a user or tool to grasp for retraction of the snare assembly 208.

[0227] In some implementations, a connector 250 (marked in FIG. 32) is provided to connect the proximal end portion 202 of the first section 200 of the retractable tether with the distal end portion 252 of the second section 210 of the retractable tether 203. The connector 250 may include the connecting member 204 and a connecting member 254 (marked in FIG. 31) of the distal end portion 252 of the second section 210 of the retractable tether 203.

[0228] In some implementations, the second section 210 of the retractable tether 203 may further include a connecting member 260 (marked in FIG. 33) at a proximal end portion 262 of the second section 210. The connecting member 260 may be adapted for coupling with the snare assembly 212 for the retractable tether 203.

[0229] In some implementations, the second section 210 of the retractable tether 203 may have a similar construction as the first section 200 of the retractable tether 203. The second section 210 of the retractable tether 203 may be made of a flexible material and may comprise sutures orAttorney Docket No: TMTTMT-23254WO01 may have another construction in some implementations. Other configurations may be utilized in some implementations.

[0230] FIG. 31 illustrates a close-up perspective view of the connecting member 204 of the first section 200 of the retractable tether 203 prior to connection with the connecting member 254 of the second section 210 of the retractable tether 203. The connecting member 204 may comprise a knot forming a plug for engagement with the connecting member 254. The connecting member 204 may have a larger size or diameter than an adjacent portion or elongate body of the first section 200.

[0231] In some implementations, the connecting member 254 of the second section 210 of the retractable tether 203 may comprise a loop or cinch body including an opening 265 for the connecting member 204 to extend through. The connecting member 254 may comprise a knot such as a soft shackle knot that is able to cinch upon the first section 200 of the retractable tether 203. In some implementations, a tube 266 may be provided for maintaining the connecting member 254 in an open position such that the connecting member 254 does not prematurely cinch or close. The connecting member 204 may pass through the tube 266 and the tube 266 may be removed. The connecting member 254 may then be cinched upon the first section 200 of the retractable tether 203. The connecting member 204 impedes retraction of the first section 200 of the retractable tether 203 from the connecting member 254. FIG. 32 illustrates the connection between the connecting members 204, 254.

[0232] In some implementations, the configuration of the connector 250 may be varied. For example, the relationship of the connecting member 204 and the connecting member 254 may be alternated in which the proximal end portion of the first section 200 of the retractable tether 203 includes the connecting member 254 (and the distal end portion of the second section 210 includes the connecting member 204). Other forms of connectors may be utilized as desired.

[0233] FIG. 33 illustrates a side view of a connection between the connecting member 260 at the proximal end portion 262 of the second section 210 of the retractable tether 203. The connecting member 260 may be adapted to connect to the snare assembly 212 for the retractable tether 203. The connecting member 260 may comprise a loop at the proximal end of the second section 210 of the retractable tether 203.

[0234] In some implementations, the snare assembly 212 may comprise a loop of material (e.g., suture or wire) for engaging the second section 210 of the retractable tether 203. The loopsAttorney Docket No: TMTTMT-23254WO01 may interlock as shown in FIG. 33. The snare assembly 212 may have other configurations in some implementations. Referring to FIG. 24, a proximal end portion 262 of the snare assembly 212 may include a grasping portion 264 for a user or tool to grasp for retraction of the snare assembly 212.

[0235] Additional components may be provided for the attachment assembly utilized to attach the unit 160 to the delivery catheter 12 in some implementations. FIG. 34, for example, illustrates an alignment sheath 270 that may be utilized in some implementations. The alignment sheath 270 may comprise a tube having an interior lumen 272 for an alignment wire 274 (marked in FIGS. 17 and 38) to extend through. The alignment sheath 270 may extend within the lumen of the frame of the device or implant 162 and may receive the alignment wire 274 extending from the elongate shaft of the delivery catheter 12. The alignment sheath 270 may serve to reduce the potential for tangling and misalignment of the various assemblies as the device or implant 162 is retracted towards the delivery catheter 12. The unit 160 may include the alignment sheath 270. FIG. 35 illustrates the unit 160 including the alignment sheath 270 in position within the lumen of the device or implant 162.

[0236] Additional components may be provided for the attachment assembly utilized to attach the unit 160 to the delivery catheter 12 in some implementations. FIG. 36, for example, illustrates a perspective view of the device or implant 162 including a locking device 280 for impeding the release tethers 192a, b, c from being withdrawn from the loop portions 172 (marked in FIG. 18).

[0237] In some implementations, the locking device 280 may comprise a holder body or disk including retaining portions 282 for retaining the release tethers 192a, b, c (marked in FIG. 37). In some implementations, the retaining portions 282 may comprise slits or slats that may retain the release tethers 192a, b, c in position. In some implementations, the locking device 280 may be positioned at the distal end portion or outflow end portion of the device or implant 162 as shown in FIG. 36. The free ends of the release tethers 192a, b, c may extend through the lumen of the device or implant 162 to reach the locking device 280 and couple to the retaining portions 282. In some implementations, the locking device 280 may retain the release tethers 192a, b, c in position as the release assembly 190 is attached to the delivery catheter 12 and advanced towards the delivery catheter 12. The possibility of premature release of the release tethers 192a, b, c may be reduced. At a desired time, the release tethers 192a, b, c may be released from the retainingAttorney Docket No: TMTTMT-23254WO01 portions 282 so that the release tethers 192a, b, c may be retracted at a desired time. The locking device 280 may be provided as part of the unit 160 in some implementations.

[0238] Additional components may be provided for the attachment assembly and as part of the unit 160 as desired.

[0239] In some implementations, the attachment assembly may be utilized to operatively attach the unit 160 to the delivery catheter 12. Referring to FIG. 17, the unit 160 is shown to include the tether assembly 164, the release assembly 190, and the device or implant 162, although other components may be included as desired. The proximal end portions of the respective tether assembly 164 and the release assembly 190 comprise free ends of the assemblies 164, 190 including the respective connecting members 188, 204. The distal end portions of the respective tether assembly 164 and release assembly 190 are coupled to the device or implant 162.

[0240] In some implementations, the second sections 206, 210 of the respective flexible retention tether 175 and retractable tether 203 may be positioned within and extend within an interior lumen of the elongate shaft, which comprises the interior lumen 290 of the mid shaft or mid shaft subassembly 24. The distal end portions 216, 252 of the second sections 206, 210 may extend from and may be positioned distal of the distal end of the mid shaft or mid shaft subassembly 24. The distal end of the mid shaft or mid shaft subassembly 24, for example, may comprise the distal pusher 138 for the mid shaft or mid shaft subassembly 24. The distal end portions 216, 252 of the second sections 206, 210 may be positioned distal of the distal end of the mid shaft or mid shaft subassembly 24 for access by a user or technician that will perform the attachment of the unit 160 to the delivery catheter 12. Improved ease of access is provided by exposing the distal end portions 216, 252 of the second sections 206, 210 distal of the distal end of the mid shaft or mid shaft subassembly 24. The connecting members 218, 254, for example, are exposed and are accessible for use by a user or technician.

[0241] In some implementations, the second sections 206, 210 of the respective flexible retention tether 175 and retractable tether 203 may extend within the interior lumen 290 proximally such that the respective proximal end portions 222, 262 are positioned within the interior lumen 290 of the mid shaft or mid shaft subassembly 24 or another lumen of the handle 16. The proximal end portions 222, 262 may be positioned distal of the respective actuator assemblies 147, 155 at this position. The proximal end portions 222, 262 may be coupled to the respective snare assemblies 208, 212. The second sections 206, 210 of the respective flexible retention tether 175Attorney Docket No: TMTTMT-23254WO01 and retractable tether 203 may not yet be engaged with the respective actuator assemblies 147, 155 at this position.

[0242] In some implementations, the proximal end portions 246, 262 of the respective snare assemblies 208, 212 may be positioned external of the handle 16 or otherwise accessible by a user or technician. The grasping portions 248, 264, for example, may be positioned for access and grasping by a user or technician.

[0243] The delivery catheter 12 as shown in FIG. 17 may include additional features, including the alignment wire 274. The alignment wire 274 may extend from the interior lumen 31 of the nose body shaft 27 and protrude from the distal end of the nose body shaft 27.

[0244] The configuration of the delivery catheter 12 shown in FIG. 17 may comprise a unit 300 that is provided to a user or technician. The unit 300 may comprise packaging that includes the delivery catheter 12 and components of the attachment assembly. The unit 300 may be packaged separately from the unit 160 in some implementations.

[0245] The unit 300 may be provided in a configuration as shown in FIG. 17 for a user or technician to be able to attach the unit 160 to the delivery catheter 12 in a medical setting or surgical facility. For example, the unit 160 may be attached to the delivery catheter 12 during a medical procedure preparatory step involved with preparing the delivery system 10 for use. The medical procedure preparatory step may be part of a delivery system preparatory procedure prior to insertion of the delivery system into the subject’s body. The user or technician may provide both the unit 300 and the unit 160 on a preparation table or other surface and may attach the unit 160 to the delivery catheter 12 prior to insertion of the delivery catheter 12 into the subject’s body.

[0246] Providing the unit 160 separate from the delivery catheter 12 may have a variety of benefits. For example, having a separate unit 160 may allow for storage and packaging of the unit 160 separate from the delivery catheter 12. As such, the sterilization and material maintenance requirements associated with the unit 160 may be kept separate from the potentially different requirements of the delivery catheter 12. Further, the overall size of an appropriate storage space (e.g., appropriate temperature and / or humidity-controlled storage space) for the unit 160 may be smaller than a storage space that would be associated with the entire assembly of the device / implant and the delivery catheter 12.

[0247] Further benefits may include different sizes of the devices / implants 162 being more readily interchanged and utilized with the delivery catheter 12 as desired. A user or technicianAttorney Docket No: TMTTMT-23254WO01 may select a desired size of device or implant 162 from a plurality of differently sized dcviccs / implants and attach that selected unit 160 to the delivery catheter 12 for deployment. Total storage space to maintain a stock of various sized devices / implants may be reduced.

[0248] In addition, complexity associated with attaching the tether assembly 164 to the device or implant 162 by a user or technician may be reduced. A variety of attachments of tethers to the device or implant may be complex for a user or technician, and as such a pre-attached tether assembly 164 may reduce the complexity associated with such attachments. The user or technician may be provided with a connector (e.g., a connector 214 as shown in FIG. 28) that may be relatively simpler to attach than a variety of tether connections to the device or implant. Reduced complexity and improved speed of connection may be provided for a user. Further, the device or implant 162 may be stored in a non-loaded or non-compressed configuration, which may improve structural properties of the device or implant 162.

[0249] A unit 160 presented to a user or technician may appear’ as shown in FIG. 35, which may include the alignment sheath 270 and may include a locking device 280 as shown in FIG. 36.

[0250] An attachment of the unit 160 to the delivery catheter 12 may occur in multiple steps. In an initial step, a packaging associated with the unit 160 may be removed. A packaging associated with the unit 300 of the delivery catheter 12 may be removed. The unit 160 may be placed adjacent to and proximate the distal end portion of the delivery catheter 12 as represented in FIG. 17.

[0251] In a configuration in which an alignment wire 274 is utilized, the alignment wire 274 may be advanced distally through the interior lumen 31 of the nose body shaft 27 and passed through an alignment sheath 270 of the unit 160. A resulting configuration is represented in FIG. 38.

[0252] In some implementations, the tether assembly 164 is adapted to be attached to the actuator assembly 147 via the flexible retention tether 175. The connector 214 for the flexible retention tether 175 may be attached. Steps as represented in FIGS. 27 and 28 may be utilized. The connecting member 188 may be inserted into the connecting member 218 to connect the connector 214.

[0253] The connector 250 for the retractable tether 203 may be attached. Steps as represented in FIGS. 31 and 32 may be utilized. The connecting member 254 may cinch upon the first section 200 of the retractable tether 203 to produce the connection.Attorney Docket No: TMTTMT-23254WO01

[0254] The connections of the connectors 214, 250 occurs at the distal end portion of the delivery catheter 12.

[0255] A resulting configuration with the connectors 214, 250 attached is shown in FIG. 38. A benefit to providing connections at the distal end portion of the delivery catheter 12 may include ease of access and connection for a user or technician. Further, the lengths of the respective first sections 174, 200 of the flexible retention tether 175 and the retractable tether 203 in the unit 160 are less than the length of the entirety of the respective flexible retention tether 175 and the retractable tether 203, thus producing less material for a technician to manipulate at the distal end portion of the delivery catheter 12. Reduced possibility of tangling at the distal end portion of the delivery catheter 12 may result.

[0256] In a configuration as shown in FIG. 38, the second sections 206, 210 of the respective flexible retention tether 175 and the retractable tether 203 may not yet be engaged with the respective actuator assemblies 147, 155 at this position. The snare assemblies 208, 212 (represented in FIG. 17) may be utilized to retract the second sections 206, 210 of the respective flexible retention tether 175 and retractable tether 203. The snare assemblies 208, 121 may be adapted to engage the respective second sections 206, 210 of the flexible retention tether 175 and retractable tether 203 and retract the second sections 206, 210 such that the second sections 206, 210 are engageable with the actuator assemblies 147, 155.

[0257] In some implementations, the retraction of the second sections 206, 210 of the respective flexible retention tether 175 and the retractable tether 203 with the snare assemblies 208, 212 may further serve to move the connectors 214, 250 proximally through the interior lumen 290 of the mid shaft or mid shaft subassembly 24. The connectors 214, 250 may proximally enter the opening 301 (marked in FIG. 11) at the distal end or pusher 138 of the mid shaft 24 and retract through the opening 301. The second sections 206, 210 of the respective flexible retention tether 175 and the retractable tether 203 may be retracted such that the connectors 214, 250 retract proximal of a position of the bend portion or rail hypotube 114 (marked in FIG. 6) of the rail shaft or subassembly 22. Such a feature may reduce the possibility of an increased size or stiffness of the connectors 214, 250 potentially interfering with the deflection or bending of the bend portion or rail hypotube 114.

[0258] FIG. 39 illustrates a configuration of an adaptor 153 that may be utilized for the actuator assembly 147 for the tether assembly 164. The adaptor 153 may be configured to engageAttorney Docket No: TMTTMT-23254WO01 with the connecting member 220 at the proximal end portion of the second section 206 of the flexible retention tether 175. The second section 206 of the flexible retention tether 175 is adapted to engage the actuator assembly 147. The adaptor 153, for example, may include a connecting member 302 that is engageable with the connecting member 220. The connecting member 302 may be configured to automatically engage with the connecting member 220. FIG. 40, for example, illustrates a perspective view of the connecting member 302 including an angled or ramped surface 304 for the connecting member 220 to slide along.

[0259] In some implementations, a stopper surface 306 may be positioned on an opposite side of the connecting member 302 than the side that the connecting member 220 is inserted towards. As such, a narrow diameter portion 308 of the second section 206 of the flexible retention tether 175 may be held at the angled or ramped surface 304 as shown in FIG. 40. The larger diameter connecting member 220 may be impeded from disengaging from the connecting member 302 due to contact with the stopper surface 306.

[0260] Referring to FIG. 39, the connecting member 302 may be spring biased to a locked or engaged position. One or more springs 310 such as coil springs or other forms of springs may be utilized to bias the connecting member 302 to the locked or engaged position. The adaptor 153 may include an opening 312 for the connecting member 220 to be slid proximally through to engage with the connecting member 302. The snare assembly 208 (not shown in FIG. 39) may be coupled to the connecting member 220 and pass proximally through the opening 312. The snare assembly 208 may be retracted through the opening 312 to pull the connecting member 220 into engagement with the connecting member 302. A position of the connecting member 220 shown in FIG. 40 may result. The snare assembly 208 may be released at this point. The actuator assembly 147 is adapted to axially advance or axially retract the flexible retention tether 175 within an interior lumen of the elongate shaft 18 to control release of the device or implant 162 from the elongate shaft 18.

[0261] FIG. 41 illustrates a configuration of the actuator assembly 155 for the release assembly 190. The spool adaptor 159 may include an opening 320 for the second section 210 of the retractable tether 203 to extend through. A connecting member 322 (marked in FIG. 42) in the form of jaws, or another form of connecting member 322 may be positioned within the opening 320. The snare assembly 212 may pass through the opening 320 and may be retracted proximally through the opening 320. The proximal end portion 262 of the second section 210 of the retractableAttorney Docket No: TMTTMT-23254WO01 tether 203 may corresponding be pulled through the opening 320 by the snare assembly 212 for connecting with the connecting member 322.

[0262] In some implementations, the connecting member 322 (in a form such as jaws) may grip the proximal end portion 262 of the second section 210 to retain the connection to the second section 210. The connecting member 322 may automatically engage the proximal end portion 262 of the second section 210. The snare assembly 212 may be released.

[0263] In some implementations, the rotatable knob 157 may be rotated to wrap the second section 210 around the spool adaptor 159 to further secure the second section 210 to the actuator assembly 155. In some implementations, a ratchet mechanism 324 may be provided for the actuator assembly 155 to allow for one-way rotation or only retraction of the retractable tether 203 in some implementations.

[0264] Referring to FIG. 43, the retraction of the snare assemblies 208, 212 through the interior lumen 290 of the mid shaft or mid shaft subassembly 24 advances the device or implant 162 towards the distal pusher 138. The device or implant 162 may slide along the alignment wire 274, with the alignment wire 274 reducing the possibility of the device or implant 162 extending off-center towards the distal pusher 138. The alignment wire 274, for example, may align the device or implant 162 such that the nose body 29 passes through the interior lumen of the device or implant 162 (rather than exterior of the device or implant 162).

[0265] In some implementations, the tether assembly 164 and the release assembly 190 may be drawn proximally through the distal pusher 138. FIG. 44, for example, illustrates aposition of the device or implant 162 relative to the distal pusher 138. At a point at which the second sections 206, 210 of the respective flexible retention tether 175 and retractable tether 203 engage with the actuator assemblies 147, 155, further retraction of the flexible retention tether 175 and retractable tether 203 may be produced by actuation of the actuator assemblies 147, 155.

[0266] In some implementations, at a position as shown in FIG. 44, a loading, crimping, or compression procedure for the device or implant 162 into the device or implant retention area 106 (marked in FIG. 5) of the outer sheath shaft or subassembly 20 may occur. In an example in which a locking device 280 is utilized, the locking device 280 may be removed at such a position. The actuator assembly 147 for the tether assembly 164 may be operated to retract the tether assembly 164 further through the distal pusher 138. The proximal end portion or inlet end portion of the device or implant 162 may be compressed radially inward to enter the distal pusher 138 asAttorney Docket No: TMTTMT-23254WO01 represented in FIG. 45. The distal pusher 138 may cover or compress the proximal end portion or inlet end portion of the device or implant 162.

[0267] In some implementations, upon the proximal end portion or inlet end portion of the device or implant 162 being compressed to a desired amount, the outer sheath shaft or subassembly 20 may be advanced distally to compress and cover the remainder of the device or implant 162. FIG. 46, for example, illustrates the outer sheath shaft or subassembly 20 being advanced distally to compress the device or implant 162 and position the device or implant within the device or implant retention area 106 (marked in FIG. 5) of the outer sheath shaft or subassembly 20. The outer sheath shaft or subassembly 20 may be advanced and may contact the nose body 29 to entirely enclose the device or implant 162.

[0268] In some implementations, the snare assemblies 208, 212 be released prior to a loading procedure as shown in FIGS. 45 and 46 or may be released following the loading procedure. FIG. 47A illustrates the snare assemblies 208, 212 having been retracted and protruding from the handle 16. In some implementations, the snare assemblies 208, 212 may be coupled together to form a joined assembly that provides a single body for a user or technician to retract. The snare assemblies 208, 212 may be cut (e.g., the snare assemblies 208, 212 may each comprise loops of material, in which a single length may be cut for retraction) and removed as desired.

[0269] FIG. 47B illustrates relative positions of components of the system prior to release of the snare assemblies 208, 212. With the snare assemblies 208, 212 released, the delivery system 10 may be prepared and in a configuration for deployment of the device or implant 162 to a treatment or implantation site.

[0270] In some implementations, the device or implant 162 may be expanded for release from the device or implant retention area 106 in a reverse operation than represented in FIGS. 44- 46. For example, referring to FIG. 48, the outer sheath shaft or subassembly 20 may be retracted proximally to uncover the distal end portion or outflow end portion of the device or implant 162. The actuator assembly 147 for the tether assembly 164 may be operated to axially advance the tether assembly 164, thus expanding the proximal end portion or inflow end portion of the device or implant 162 from the distal pusher 138. A resulting configuration is shown in FIG. 48.

[0271] At a desired time for release of the tether assembly 164 from the device or implant 162, the actuator assembly 155 may be operated to retract the release assembly 190. The rotatableAttorney Docket No: TMTTMT-23254WO01 knob 157 (marked in FIG. 41) may be rotated to wrap the second section 210 of the retractable tether 203 onto the spool adaptor 159 (marked in FIG. 1).

[0272] FIGS. 49 and 50 illustrate a retraction sequence of the release assembly 190, and particularly of the release tethers from the loop portions 172 of the coupling tethers 168. FIG. 49 illustrates the release tether 192a being pulled proximally to retract from the loop portion 172a. The loop portion 172a is accordingly free to be released from the eyelet 165a. The release tether 192a may continue to be retracted with the free end 311 pulling through the loop portions 172b, c. FIG. 50, for example, illustrates the release tether 192a having been retracted from each loop portion 172a, b, c. The remaining release tethers (e.g., release tethers 192b, c) may be retracted in a similar manner.

[0273] FIG. 51 illustrates the device or implant 162 released and free from the tether assembly 164.

[0274] FIGS. 52-57 illustrate an exemplary deployment sequence for the example device or implant 162 from the delivery catheter 12. FIG. 52 illustrates a schematic representation of a delivery approach to a native tricuspid valve. As shown in FIG. 52, in one example the elongate shaft 18 of the delivery system can be placed in the ipsilateral femoral vein 330 and advanced toward the right atrium 332. The approach can be from the inferior vena cava (or from the superior vena cava) in some implementations.

[0275] FIG. 52 shows the elongate shaft 18 extending from the ipsilateral femoral vein 330 to the right atrium 332. In some implementations of the disclosure, a guide wire is not necessary to position the elongate shaft 18 in the proper position, although in other examples, one or more guide wires may be used.

[0276] Accordingly, it can be advantageous for a user to be able to steer the elongate shaft 18 through the complex areas of the heart in order to position a replacement tricuspid valve in line with the native tricuspid valve. This task can be performed with or without the use of a guide wire with the above disclosed system. The distal end of the elongate shaft 18 can be advanced into the right atrium 332. A user can then manipulate the rail subassembly 22 to target the distal end of the elongate shaft 18 to the appropriate area. Further, a user can torque the delivery catheter 12 to further manipulate and control the position of the elongate shaft 18. In the fully bent configuration, a user can then place the replacement valve in the proper location. This can advantageously allowAttorney Docket No: TMTTMT-23254WO01 delivery of a device (e.g., replacement valve, treatment device, etc.) to an in-situ treatment or implantation site, such as a native tricuspid valve.

[0277] FIG. 53 illustrates a schematic representation of a distal end of the elongate shaft 18 approaching a native tricuspid valve. The distal end of the elongate shaft 18 may be positioned as desired relative to the treatment or implantation site prior to release of a device or implant from the device or implant retention area.

[0278] FIG. 54 illustrates that the device or implant may be released from the elongate shaft 18 with the tether assembly 164 coupled to the device or implant. The position of anchors relative to the native valve leaflets may be determined, and if in proper position the treatment or implantation procedure may proceed.

[0279] FIG. 55 illustrates the device or implant in an expanded configuration, with the tether assembly 164 coupled to the device or implant. The release assembly 190 may retain the tether assembly 164 to the device or implant in such a configuration.

[0280] The tether assembly 164 may be released from the device or implant utilizing the release assembly 190. FIG. 56 illustrates release of the tether assembly 164. FIG. 57 illustrates the device or implant deployed in position.

[0281] A similar deployment procedure may be utilized with a mitral valve as desired. For example, a transseptal puncture can be performed from the right atrium 332 to obtain access to the left atrium 334 (marked in FIG. 52). A user can pass the bent elongate shaft 18 through the transseptal puncture and into the left atrium 334. A user can then further manipulate the elongate shaft 18 to create an even greater bend in the rail subassembly 22. The elongate shaft 18 can then be advanced into the left atrium 334 and then towards the left ventricle 336. The device or implant may be deployed in a similar manner as shown in FIGS. 53-57.

[0282] Other forms of delivery procedures may be utilized in some implementations.

[0283] The devices, systems, and methods of FIGS. 1-57 may be utilized solely or in combination with any other example disclosed herein. Variations in the devices, systems, and methods may be provided in some implementations.

[0284] Variations in the configurations of the components disclosed herein may be utilized in some implementations. FIG. 58, for example, illustrates a variation in a form of a connector 340 that may be utilized in some implementations herein. The connector 340 may comprise a knot joining two connecting members 342a, b, each in the form of a loop. The knot may comprise aAttorney Docket No: TMTTMT-23254WO01 square knot, or may comprise a larkshead or cowhitch knot in some implementations. The knot may be utilized to join two components herein, which may comprise the connection between the tether assembly 164 and the second section 206 of the flexible retention tether 175 in some implementations (e.g., in substitution for the connector 214 shown in FIG. 28). In some implementations, other connectors may have a configuration as shown in FIG. 58 (e.g., a connector between the release assembly 190 and the second section 210 of the retractable tether 203, or a connector to a snare assembly, among other connectors).

[0285] FIGS. 59A and 59B illustrate a variation in a form of a connector 350 that may be utilized in some implementations herein. The connector 350 may comprise a juncture of two loops, with a first loop comprising a connecting member 352a in the form of a ring, and a second loop comprising a connecting member 352b in the form of a hook. The ring may be passed through the free end of the hook to engage with the hook, as represented in FIG. 59B. In variations, multiple connecting members 352b, c (as shown in FIG. 60) in the form of overlapping and opposed hooks may be utilized. The connectors of FIGS. 59A-60 may be utilized to join two components herein, which may comprise the connection between the tether assembly 164 and the second section 206 of the flexible retention tether 175 in some implementations (e.g., in substitution for the connector 214 shown in FIG. 28). In some implementations, other connectors may have a configuration as shown in FIGS. 59A-60 (e.g., a connector between the release assembly 190 and the second section 210 of the retractable tether 203, or a connector to a snare assembly, among other connectors).

[0286] FIG. 61 illustrates a variation in a form of a connector 360 that may be utilized in some implementations herein. The connector 360 may comprise a loop engaged with a plug, with the loop comprising a connecting member 362a and the plug comprising a connecting member 362b. The plug may be shaped to initially pass through the loop of the connecting member 362a, yet its large size or diameter may impede release from the loop. In some implementations, the loop may comprise a non-cinching loop, or may comprise a cinching loop in some implementations. The connector 360 may be utilized to join two components herein, which may comprise the connection between the tether assembly 164 and the second section 206 of the flexible retention tether 175 in some implementations (e.g., in substitution for the connector 214 shown in FIG. 28). In some implementations, other connectors may have a configuration as shownAttorney Docket No: TMTTMT-23254WO01 in FIG. 61 (e.g., a connector between the release assembly 190 and the second section 210 of the retractable tether 203, or a connector to a snare assembly, among other connectors).

[0287] FIGS. 62A-62C illustrates a variation in a form of a connector 370 that may be utilized in some implementations herein. The connector 370 may comprise a loop engaged with a plug, with the loop comprising a connecting member 372a in the form of a wire loop. The plug may comprise a connecting member 372b in the form of a wide end of a relatively narrower body 376, with the wide end being sized larger than the opening 378 formed by the wire loop.

[0288] In some implementations, the wire loop may include one or more wraps of the wire, forming a coil or helical shape. Adjacent portions 374 of the connecting member 372a may result.

[0289] In some implementations, the plug may be passed between the adjacent portions 374 as represented in FIG. 62B. The plug may then be positioned on a first side of the opening 378, with the narrower body 376 passing through the second opposite side of the opening 378 as shown in FIG. 62C. The large size or diameter of the plug may impede release from the wire loop.

[0290] In some implementations, the connector 370 may be utilized to join two components herein, which may comprise the connection between the tether assembly 164 and the second section 206 of the flexible retention tether 175 in some implementations (e.g., in substitution for the connector 214 shown in FIG. 28). In some implementations, other connectors may have a configuration as shown in FIGS. 62A-62C (e.g., a connector between the release assembly 190 and the second section 210 of the retractable tether 203, or a connector to a snare assembly, among other connectors).

[0291] FIGS. 63 A and 63B illustrate a variation in a form of a connector 380 that may be utilized in some implementations herein. The connector 380 may comprise a juncture of two loops, with a first loop comprising a connecting member 382a in the form of a hook or open loop, and a second loop comprising a connecting member 382b in the form of a closed loop. A connecting member 384 in the form of a crimp body may be provided to close the open loop of the connecting member 382a.

[0292] Referring to FIG. 63B, the connecting member 382a may be hooked around the connecting member 382b. The connecting member 384 in the form of the crimp body may then be crimped to the connecting member 382a to close the open loop.

[0293] In some implementations, the connector of FIGS. 63 A and 63B may be utilized to join two components herein, which may comprise the connection between the tether assembly 164Attorney Docket No: TMTTMT-23254WO01 and the second section 206 of the flexible retention tether 175 in some implementations (e.g., in substitution for the connector 214 shown in FIG. 28). In some implementations, other connectors may have a configuration as shown in FIGS. 63A and 63B (e.g., a connector between the release assembly 190 and the second section 210 of the retractable tether 203, or a connector to a snare assembly, among other connectors).

[0294] FIGS. 64A-64D illustrate a variation in a form of a connector 390 that may be utilized in some implementations herein. The connector 390 may comprise a connecting member 392a in the form of an open loop or hook, and a connecting member in the form of a cinch body 392b.

[0295] In some implementations, the connecting member 392a may comprise a relatively stiff material such as a wire that may retain its shape upon coupling to the cinch body 392b.

[0296] In some implementations, the cinch body 392b may include a shaped body having a channel 394 for a cinch tether 396 to cinch upon the connecting member 392a. The channel 394 may be a first channel and the cinch body 392b may include a second channel 398 for the connecting member 392a to be initially passed through.

[0297] FIGS. 64A-64C illustrate a connection procedure for the connector 390. In FIG. 64A, the connecting member 392a is shown separate from the cinch body 392b, with the cinch tether 396 forming an open loop 400 around the channel 394. The cinch tether 396 may extend distally and pass through the second channel 398 to form the open loop 400 around the first channel 394.

[0298] Referring to FIG. 64B, the connecting member 392a may be passed through the channel 398. The connecting member 392a may then be rotated such that the open end or free end 402 of an arm 404 of the connecting member 392a is aligned with the first channel 394. The connecting member 392a may then be retracted distally through the first channel 394 with the open loop 400 surrounding the arm 404 of the connecting member 392a (as shown in FIG. 64C).

[0299] Referring to FIG. 64C, the cinch tether 396 may be retracted proximally to cinch upon the arm 404 of the connecting member 392a.

[0300] Referring to FIG. 64D, in some implementations, the cinch body 392b may include a channel 406 in an outer surface of the cinch body 392b. The channel 406 may comprise an indentation in the outer surface of the cinch body 392b and shaped to accommodate the nose body shaft 27 or other shaft that may be positioned adjacent to the cinch body 392b.Attorney Docket No: TMTTMT-23254WO01

[0301] In some implementations, the connector 390 of FIGS. 64A-64D may be utilized to join two components herein, which may comprise the connection between the tether assembly 164 and the second section 206 of the flexible retention tether 175 in some implementations (e.g., in substitution for the connector 214 shown in FIG. 28). In some implementations, other connectors may have a configuration as shown in FIGS. 64A-64D (e.g., a connector between the release assembly 190 and the second section 210 of the retractable tether 203, or a connector to a snare assembly, among other connectors).

[0302] FIG. 65A illustrates a variation in a form of a connector 410 that may be utilized in some implementations herein. In some implementations, the connector 410 may comprise a mechanical snap connector having interlocking connecting members 412a, b. The first connecting member 412a may be shaped to lock with a cavity in the second connecting member 412b. A user may mechanically join the connecting members 412a, b. The connector 410 may be utilized to join two components herein, which may comprise the connection between the tether assembly 164 and the second section 206 of the flexible retention tether 175 in some implementations (e.g., in substitution for the connector 214 shown in FIG. 28). In some implementations, other connectors may have a configuration as shown in FIG. 65A (e.g., a connector between the release assembly 190 and the second section 210 of the retractable tether 203, or a connector to a snare assembly, among other connectors).

[0303] FIGS. 65B and 65C illustrate a variation in a form of a connector 420 that may be utilized in some implementations herein. In some implementations, the connector 420 may comprise a mechanical snap connector having interlocking connecting members 422a, b. The first connecting member 422a and second connecting member 422b may each have protrusions shaped to interlock with each other. The first connecting member 422a and second connecting member 422b may each comprise a tube, with the tube shaped to form the protrusions. The protrusions may be formed in the end surfaces of the tubes. FIG. 65C illustrates the connecting members 422a, b interlocked with each other. The protrusions may retain a lock upon a distal pushing force being applied to the connector 420 and a proximal retraction force applied to the connector 420.

[0304] In some implementations, the connector 420 may be utilized to join two components herein, which may comprise the connection between the tether assembly 164 and the second section 206 of the flexible retention tether 175 in some implementations (e.g., in substitution for the connector 214 shown in FIG. 28). In some implementations, other connectorsAttorney Docket No: TMTTMT-23254WO01 may have a configuration as shown in FIGS. 65B and 65C (e.g., a connector between the release assembly 190 and the second section 210 of the retractable tether 203, or a connector to a snare assembly, among other connectors).

[0305] FIGS. 65D and 65E illustrate a variation in a form of a connector 430 that may be utilized in some implementations herein. In some implementations, the connector 430 may comprise a loop engaged with a protrusion, with the loop comprising a connecting member 432b and the protrusion comprising a connecting member 432a in the form of a cam body. The loop may comprise a wire loop in some implementations. In some implementations, the loop may be looped around the connecting member 432a and then rotated in position to engage with the cam feature of the cam body. FIG. 65E illustrates the connecting member 432b having been rotated to engage with the cam feature of the cam body. The engagement of the cam body may allow the connection to be maintained upon a distal pushing force being applied to the connector 430 and a proximal retraction force applied to the connector 430. The connector 430 may be utilized to join two components herein, which may comprise the connection between the tether assembly 164 and the second section 206 of the flexible retention tether 175 in some implementations (e.g., in substitution for the connector 214 shown in FIG. 28). In some implementations, other connectors may have a configuration as shown in FIGS. 65D and 65E (e.g., a connector between the release assembly 190 and the second section 210 of the retractable tether 203, or a connector to a snare assembly, among other connectors). Other forms of connectors, such as clips, adhesives, or magnets may be utilized as desired.

[0306] In some implementations, the connectors as shown in FIGS. 58-65E may be utilized in a configuration of an attachment assembly as shown in FIG. 24. For example, the connectors as shown in FIGS. 58-65E may be utilized in an example in which the flexible retention tether and retractable tether are provided in sections, and the flexible retention tether and retractable tether are retracted for engagement with the respective actuator assemblies 147, 155.

[0307] In some implementations, the connectors as shown in FIGS. 58-65E may be utilized in an arrangement in which the flexible retention tether and retractable tether are preattached with and engaged with the respective actuator assemblies 147, 155. For example, the flexible retention tether and retractable tether may be attached to the respective actuator assemblies 147, 155 and the user or technician may produce the connections to the tether assembly 164 and release assembly 190 at the distal end portion of the delivery catheter 12. The second sectionsAttorney Docket No: TMTTMT-23254WO01206, 210 of the flexible retention tether and the retractable tether may be engaged with the actuator assemblies 147, 155. The actuator assemblies 147, 155 may then be utilized to retract the flexible retention tether and retractable tether as desired. The use of snare assemblies 208, 212 may be excluded in such examples.

[0308] In some implementations, the flexible retention tether and the retractable tether may not be separated into sections separate from the device / implant unit, and the entirety of the flexible retention tether and the retractable tether may comprise part of a device / implant unit as disclosed herein. FIG. 66, for example, illustrates a configuration of a unit 440 including the device or implant 162. The tether assembly 442 of the unit 440 may be configured similarly as the tether assembly 164 of the unit 160 (marked in FIG. 17), yet may include the entirety of the flexible retention tether 444 (whereas the tether assembly 164 included a portion or a first section 174 of a flexible retention tether 175).

[0309] In some implementations, the release assembly 446 of the unit 440 may be configured similarly as the release assembly 190 of the unit 160 (marked in FIG. 17), yet may include the entirety of the retractable tether 448 (whereas the release assembly 190 included a portion or a first section 200 of the retractable tether 203). In some implementations herein, the tether assemblies may include at least a portion of a flexible retention tether, and the release assemblies may include at least a portion of a release tether.

[0310] FIG. 67A illustrates components of the attachment assembly for the unit 440. The attachment assembly may include the tether assembly 442, the snare assembly 208, the release assembly 446, and the snare assembly 212.

[0311] In some implementations, the tether assembly 442 may be configured similarly as the tether assembly 164 of the unit 160 unless stated otherwise. The tether assembly 442 may include the coupling tethers 168 and may include a manifold 450 that may be configured similarly as the manifold 170 unless stated otherwise. The flexible retention tether 444 may extend to a proximal end portion 452 that includes the connecting member 220. The connecting member 220 is adapted to engage the snare assembly 208 in a similar manner as discussed in regal'd to FIGS. 29 and 30.

[0312] In some implementations, the release assembly 446 may be configured similarly as the release assembly 190 of the unit 160 unless stated otherwise. The release assembly 446 may include the release tethers 192 and may include the manifold 198. The retractable tether 448 mayAttorney Docket No: TMTTMT-23254WO01 extend to a proximal end portion 454 that includes the connecting member 260. The connecting member 260 is adapted to engage the snare assembly 212 in a similar manner as discussed in regard to FIG. 33.

[0313] Referring to FIG. 66, the tether assembly 442 and release assembly 446 may each be pre-attached to the device or implant 162 and provided as part of the unit 440 in a similar manner as discussed regarding the unit 160. The unit 440 may be provided and packaged in a similar manner as the unit 160.

[0314] In some implementations, the snare assemblies 208, 212 may be provided as part of a unit 460 comprising the delivery catheter 12 in some implementations. The unit 460 may be configured similarly as the delivery catheter unit 300 shown in FIG. 17 unless stated otherwise. The snare assemblies 208, 212 may extend within a lumen of the delivery catheter 12 (e.g., the interior lumen 290 of the mid shaft or mid shaft subassembly 24). The distal end portions of the snare assemblies 208, 212 may protrude distally from the distal end or distal pusher 138 of the mid shaft or mid shaft subassembly 24. The snare assemblies 208, 212 may be positioned to be accessible by a user or technician.

[0315] In some implementations, the proximal end portions 246, 262 of the respective snare assemblies 208, 212 may remain exterior of the handle 16 and accessible for a user or technician to retract through the interior lumen of the delivery catheter 12.

[0316] In an attachment procedure, the connecting member 220 of the flexible retention tether 444 may be engaged with the snare assembly 208. The connecting member 260 of the retractable tether 448 may be engaged with the snare assembly 212. The snare assembly 208 may then be retracted proximally through the interior lumen of the delivery catheter 12 until the flexible retention tether 444 engages with the actuator assembly 147. A method of engagement as discussed in regard to FIGS. 39 and 40 may be utilized, among other methods. Similarly, the snare assembly 212 may be retracted proximally through the interior lumen of the delivery catheter 12 until the retractable tether 448 engages with the actuator assembly 155. A method of engagement as discussed in regard to FIGS. 41 and 42 may be utilized, among other methods.

[0317] In some implementations, a loading procedure as discussed in regard to FIGS. 44- 46 may be utilized to load the device or implant 162 to the device or implant retention area 106 (marked in FIG. 5) of the outer sheath shaft or subassembly 20.Attorney Docket No: TMTTMT-23254WO01

[0318] A resulting configuration of the flexible retention tether 444 and retractable tether 448 is illustrated schematically in FIG. 67B. The snare assemblies 208, 212 may be released in a similar manner as disclosed herein.

[0319] In a configuration as represented in FIGS. 66-67B, a greater length of the flexible retention tether 444 and retractable tether 448 is provided as pail of the unit 440 in comparison with the length of the sections of the flexible retention tether and retractable tether provided as part of the unit 160 (marked in FIG. 17). In some implementations, a mechanism may be provided to account for the greater length of at least the flexible retention tether 444 during an attachment procedure. FIGS. 68A-68C illustrate an operation of such a mechanism.

[0320] Referring to FIG. 68A, the mechanism may include a slide coupling between the manifold 450 and the flexible retention tether 444. For example, the flexible retention tether 444 may include a loop of wire (or doubled lengths 444a, b of wire) having the bend portion 445 or “U” portion of the loop remote from the manifold 450. The majority of the length of the flexible retention tether 444, for example, may be wound about a spool 470 or other form of payout mechanism.

[0321] In some implementations, the manifold 450 may include a loop body 472 having an opening 474 that a length 444a of the flexible retention tether 444 extends through. The other length 444b of the flexible retention tether 444 may be positioned exterior of the opening 474. As such, as the snare assembly 208 proximally retracts the flexible retention tether 444 for passage into the interior lumen of the delivery catheter 12, the lengths 444a, b of the flexible retention tether 444 may slide along the loop body 472.

[0322] A benefit to a configuration as represented in FIG. 68A is that the device or implant 162 coupled to the manifold 450 may remain in a static position or in a desired alignment with the delivery catheter 12 upon retraction of the flexible retention tether 444.

[0323] The flexible retention tether 444 may continue to be retracted and drawn from the spool 470 as represented in FIG. 68B. The flexible retention tether 444 may continue to be redacted until the bend portion 445 or “U” portion of the loop catches against the loop body 472 as represented in FIG. 68C. The flexible retention tether 444 may accordingly move and retract the device or implant 162 in a loading procedure as desired.

[0324] The release assembly 446 may be drawn into the interior lumen of the delivery catheter 12 along with the movement and retraction of the flexible retention tether 444. A lockingAttorney Docket No: TMTTMT-23254WO01 device 280 as disclosed herein may be utilized to impede premature retraction of the release assembly 446.

[0325] The features of FIGS. 66-68C may be utilized solely or in combination with any other example disclosed herein.

[0326] In some implementations, other configurations of connecting members for connecting with the snare assemblies 208, 212 may be utilized in some implementations. FIG. 69A, for example, illustrates a variation of the connecting member 220, comprising a connecting member 482 having a curved or non-linear slot 480 for receiving a snare assembly. The connecting member 482 may otherwise be configured similarly as the connecting member 220. The curved or non-linear shape of the slot 480 may reduce the possibility of a snare assembly from coming loose prematurely from the connecting member 482.

[0327] FIG. 69B illustrates a further variation of the connecting member 220 including a connecting member 486 having a cavity 484 for receiving the snare assembly. The connecting member 486 may otherwise be configured similarly as the connecting member 220. The increased size of the cavity 484, as compared to a slot or slit, may improve the ease of connection between the snare assembly and the connecting member 486.

[0328] Connecting members for the retractable tether may include similar features as disclosed in regard to FIGS. 69A and 69B in some implementations.

[0329] FIGS. 70A-71B illustrate examples of release mechanisms for snare assemblies that automatically disengage the snare assembly from the respective flexible retention tether or the retractable tether. Referring to FIG. 70A, for examples, a snare assembly 490 may include a connecting member in the form of one or more deflectable tabs 492 for coupling with respective portions of a flexible retention tether or retractable tether. FIG. 70A illustrates a proximal end portion 494 of a flexible retention tether 496 including a connecting member in the form of openings 498 for receiving the deflectable tabs 492. The proximal end portion 494 of the flexible retention tether 496 may include a central channel or lumen 500 for insertion of the snare assembly 490. The snare assembly 490 may insert into the central channel or lumen 500 with the deflectable tabs 492 protruding through the openings 498. A cross-sectional view of the resulting configuration is shown in FIG. 70B.

[0330] The snare assembly 490 coupled to the flexible retention tether 496 may be retracted proximally through the delivery catheter 12 as disclosed herein. The delivery catheterAttorney Docket No: TMTTMT-23254WO0112 may include a pressing surface 502 (marked in FIG. 70C) that may press the deflectable tabs 492 radially inward as represented in FIG. 70C. The pressing surface 502 may comprise a part of an adaptor of the delivery catheter, such as an adaptor 153 illustrated in FIG. 39. As such, as the snare assembly 490 retracts proximally through the interior lumen of the delivery catheter 12, the connecting member for the flexible retention tether 496 may engage with the adaptor 153. The snare assembly 490 may automatically disengage from the flexible retention tether 496 after the flexible retention tether 496 engages with the adaptor 153. A configuration as represented in FIGS. 70A-70C may be utilized with a retractable tether in some implementations. Other forms of release mechanisms may be utilized in some implementations.

[0331] FIGS. 71A and 7 IB illustrate a configuration of a release mechanism that may be utilized for a snare assembly 510. The snare assembly 510 may comprise a connecting member in the form of a loop of wire that is deflectable radially inward to reduce a size of an opening 512 for receiving a proximal end portion of a retractable tether. The loop of wire is shown in an expanded state in FIG. 71A with the size of the opening 512 increased. The retractable tether may extend within the opening 512. A pressing surface 514 in the form of a tube may press the loop of wire radially inward as the snare assembly 510 retracts through the tube. FIG. 7 IB illustrates such a state, in which the deflected state of the snare assembly 510 grips the retractable tether.

[0332] The deflected snare assembly 510 may be retracted proximally through the tube until a desired time of release of the snare assembly 510. For example, the snare assembly 510 may pass proximally from the proximal end portion of the tube and may expand radially outward to automatically release from the retractable tether. The release from the retractable tether may occur after the retractable tether has been engaged with an actuator assembly such as an actuator assembly 155 shown in FIG. 41. A configuration as represented in FIGS. 71A-71B may be utilized with a flexible retention tether in some implementations. Other forms of release mechanisms may be utilized in some implementations.

[0333] Other forms of adaptors for automatically engaging with a flexible retention tether or a retractable tether may be utilized in some implementations. FIGS. 72 A and 72B illustrate a variation of the adaptor 153 shown in FIG. 39, in which the spring 520 comprises a leaf spring (rather than a coil spring 310 as shown in FIG. 39). The leaf spring 520 may be compressed by the movement of the connecting member 220, to engage with the connecting member 220 as shown in FIG. 72B. Other configurations of adaptors may be utilized in some implementations.Attorney Docket No: TMTTMT-23254WO01

[0334] FIGS. 73 and 74 illustrate a variation of the adaptor 153 shown in FIG. 39, in which the connecting member 530 comprises deflectable pins for engaging the narrow diameter portion 308 of the flexible retention tether. The pins may be spring biased to automatically deflect inward and engage the narrow diameter portion 308 of the flexible retention tether. The automatic engagement mechanisms of the adaptors shown in FIGS. 72A-74 may be utilized with a flexible retention tether or with a retractable tether in some implementations. Features of the automatic engagement mechanisms of FIGS. 72A-74 may be utilized solely or in combination with any example disclosed herein. In some implementations, other forms of engagement mechanisms (e.g., a bal-seal connector may be utilized).

[0335] In some implementations, an interior lumen of the delivery catheter 12 may include an elongate partition for separating the retractable tether from the flexible retention tether. Referring to FIG. 75, for example, an elongate partition 540 may comprise a portion of the mid shaft or mid shaft subassembly 24. The elongate partition 540 may include a channel 542 for receiving the retractable tether, a channel 544 for receiving the flexible retention tether and may include a channel 546 for the nose body shaft 27 to extend through. The elongate partition 540 may include elongate banners or walls that separate the respective components. In some implementations, the elongate partition 540 may serve to reduce the possibility of tangling between the various components. Further, the elongate partition 540 may allow for reinsertion of a snare assembly in a distal direction if a connection to a snare assembly is lost within the lumen of the delivery catheter 12. A reconnection with a tether assembly and / or a release assembly may be made with the snare assembly, with the snare assembly having previously lost the connection with the respective tether assembly or release assembly within the delivery catheter 12. The elongate partition 540 may reduce the possibility of a disconnected snare assembly from tangling with other components within the interior lumen of the delivery catheter 12 in some implementations.

[0336] The elongate partition 540 may be static relative to the mid shaft adaptor 136, or may be slidable relative to the mid shaft adaptor 136 in some implementations. FIG. 75 illustrates a static elongate partition 540 that may be utilized. In some implementations, an elongate partition 550 (marked in FIG. 76A) that is slidable within the interior of the delivery catheter 12 may be utilized. The elongate partition 550 may be positioned within the elongate shaft of the delivery catheter 12 in some implementations. The elongate partition 550 may be positioned within the interior lumen 290 of the mid shaft or mid shaft subassembly 24 in some implementations. TheAttorney Docket No: TMTTMT-23254WO01 elongate partition 550 may slide relative to the snare assemblies upon retraction of the snare assemblies and the connected flexible retention tether and retractable tether. FIG. 76B illustrates an end view of the elongate partition 550, showing the respective channel 552 for the retractable tether, the channel 554 for the flexible retention tether, and the channel 556 for the nose body shaft 27.

[0337] FIGS. 77A-77D illustrate a variation of a slidable elongate partition 560 that is provided as part of the device / implant unit (such as device / implant unit 440 shown in FIG. 66). The partition 560 may be fixedly coupled to at least one of the flexible retention tether 562 or the retractable tether 564. FIG. 77A illustrates the partition 560 fixedly coupled to the proximal end portion 566 of the flexible retention tether 562. A coupling member 568 (which may be configured to couple with an actuator assembly in a similar manner as the connecting member 220) for the flexible retention tether 562 may protrude proximally from the partition 560. The distal end portion 570 of the flexible retention tether 562 may be pre- attached to a device or implant as disclosed herein.

[0338] The flexible retention tether 562, the partition 560, and the retractable tether 564 may be provided as pail of a device / implant unit including the device or implant. The flexible retention tether 562 may be attached to a tether assembly coupled to the device or implant, and the retractable tether 564 may be coupled to a release assembly coupled to the device or implant. A snare assembly 212 may be provided separate from the unit.

[0339] The partition 560 may include a channel 572 for receiving the snare assembly 212 therethrough. The snare assembly 212 may be passed through the partition 560 to engage the proximal end portion 574 of the retractable tether 564.

[0340] The proximal end portion 574 of the retractable tether 564 may include a stopper or plug 576 sized larger than a portion of the channel 572 such that the plug 576 cannot pass entirely through the channel 572. As such, the snare assembly 212 may engage the retractable tether 564 and be used to pull the partition 560, the flexible retention tether 562, and the retractable tether 564 simultaneously proximally through the interior lumen 290 (marked in FIG. 11) of the mid shaft or mid shaft subassembly 24. As such, a single snare assembly 212 may be utilized to retract both the flexible retention tether 562 and the retractable tether 564. The flexible retention tether 562 and the retractable tether 564 may be retracted and engaged with respective actuator assemblies 147, 155 utilizing methods disclosed herein.Attorney Docket No: TMTTMT-23254WO01

[0341] FIG. 77B illustrates a side cross sectional view of the partition 560. The partition 560 may include a channel 578 for receiving the flexible retention tether 562, which may be fixed in position within the channel 578. FIG. 77C illustrates an end view of the partition 560, illustrating the relative positions of the channels 572, 578. The partition 560 may further include a channel 580 for receiving the nose body shaft 27. The partition 560 may slide along the nose body shaft 27 upon being slid proximally within the interior lumen 290 of the mid shaft or mid shaft subassembly 24. The nose body shaft 27 accordingly may serve as a rail that the partition 560 slides along upon moving proximally.

[0342] FIG. 77D illustrates a perspective view of a variation of the partition 560 in which channels 572a, 578a corresponding to the respective channels 572, 578 are cut to extend through the outer surface of the partition 560a.

[0343] Features of the partitions of FIGS. 75-77D may be utilized solely or in combination with any example disclosed herein.

[0344] Other configurations of attachment assemblies may be utilized in some implementations. FIGS. 78A-78C, for example, illustrate a variation in which a pull tether 590 is utilized to retract both the flexible retention tether 592 and the retractable tether 594 simultaneously. The pull tether 590 may further be utilized to actuate the retractable tether 594. Referring to FIG. 78A, the retractable tether 594 may have a proximal end portion 596 directly coupled to the flexible retention tether 592. The coupling may occur at a midpoint of the flexible retention tether 592. Other positions of coupling may be utilized in some implementations. The distal end portion of the retractable tether 594 may couple to release tethers 598 as disclosed herein.

[0345] The flexible retention tether 592 may include a distal end portion 600 coupled to coupling tethers 602 as disclosed herein. The proximal end portion 604 of the flexible retention tether 592 may include a connecting member 606 as disclosed herein (which may be configured to couple with an actuator assembly in a similar manner as the connecting member 220). A body 607 having a split channel 608 or “Y” channel may be provided. A first channel 610 of the body 607 may be for receiving the proximal end portion of the flexible retention tether 592. The second channel 612 may be for receiving the pull tether 590 and a laterally deflected portion of the retractable tether 594 as shown in FIG. 78C. The second channel 612 may extend laterally from the first channel 610.Attorney Docket No: TMTTMT-23254WO01

[0346] An interior lumen of the delivery catheter 12 (such as the interior lumen 290 of the mid shaft or mid shaft subassembly 24) may extend around the pull tether 590, the retractable tether 594, and the flexible retention tether 592 in a configuration as shown in FIG. 78A. The size of the interior lumen may impede the pull tether 590 from deflecting the retractable tether 594 such that the retractable tether 594 moves laterally or radially outward from a configuration as shown in FIG. 78A. Such movement may be impeded until the proximal end of the retractable tether 594 reaches the second channel 612.

[0347] FIG. 78B, for example, illustrates the retraction of the pull tether 590 to retract both the flexible retention tether 592 and the retractable tether 594. The connecting member 606 may be engaged with an actuator assembly 147 as disclosed herein. The retractable tether 594, however, may be actuatable via the pull tether 590. Referring to FIG. 78C, the pull tether 590 may be pulled laterally through the second channel 612 to correspondingly pull the retractable tether 594 laterally. The lateral movement of the retractable tether 594 may retract the release tethers 598 relative to the coupling tethers 602 to release the device or implant as disclosed herein.

[0348] Benefits of a configuration as shown in FIGS. 78A-78C include the pull tether 590 being utilized for retraction of both the retractable tether 594 and the flexible retention tether 592 simultaneously. Further, the pull tether 590 may be utilized for actuation of the release tethers 598.

[0349] Features of FIGS. 78A-78C may be utilized solely or in combination with any other example disclosed herein.

[0350] Other configurations of attachment assemblies may be utilized in some implementations. FIGS. 79A-79C illustrate a variation in which a unit 620 includes a device or implant 622 that may be configured similarly as the device or implant 162 unless stated otherwise. The unit 620 may include a tether assembly 624 in the form of a ring that extends through a plurality of the eyelets 626 of the device or implant 622. The ring is pre-attached to the device or implant 622 as part of the unit 620. The ring may be configured to remain coupled to the device or implant 622 upon deployment of the device or implant 622 to a treatment or implantation site.

[0351] The delivery system may include connectors in the form of hooks 628 for engaging the tether assembly 624. The hooks 628 may be selectively engageable with the tether assembly 624 via an actuatable sheath 630 (marked in FIG. 79C). The hooks 628 may comprise a portionAttorney Docket No: TMTTMT-23254WO01 of a flexible retention tether that may extend along an interior lumen of a delivery catheter 12 as disclosed herein.

[0352] Referring to FIG. 79C, the device or implant 622 may be deployed with the hooks 628 locked in position. The actuatable sheath 630 may then been retracted to allow the hooks 628 to release from the tether assembly 624. The device or implant 622 may remain in a deployed position or implanted position with the tether assembly 624 remaining coupled to the device or implant 622.

[0353] Benefits of a configuration as shown in FIGS. 79A-79C include ease of attachment of the tether assembly 624 to the hooks 628 prior to loading of the device or implant 622 to the delivery catheter 12. The hooks 628 may be engaged with the tether assembly 624 rapidly by a user or technician prior to loading of the device or implant 622 to the delivery catheter. Further, the tether assembly 624 is pre-attached to the device or implant 622, which may reduce complexity associated with threading the tether assembly 624 through the eyelets 626 prior to attachment to the delivery catheter 12.

[0354] Features of FIGS. 79A-79C may be utilized solely or in combination with any other example disclosed herein.

[0355] In some implementations, devices may be provided to improve ease in which a tether assembly is attached to a device or implant. Such examples may differ from examples as shown in FIGS. 17 and 66, in which the tether assembly is pre-attached to the device or implant as part of a unit. In some implementations, devices may be provided that more easily allow a user or technician to attach a tether assembly to a device or implant prior to loading of the device or implant to a delivery catheter 12.

[0356] Referring to FIG. 80A, for example, a tether threading device 640 may be provided for threading a tether assembly through a plurality of eyelets of a device or implant 162. The tether threading device 640 may be provided with the device or implant 162 in a unit, or may be provided separately from the device or implant 162 in some implementations and utilized by a user or technician. The tether threading device 640 may include one or more snares 642 that may each extend through a respective one of the eyelets 644 of the device or implant 162. The snares 642 may be provided pre-inserted through the eyelets 644 as part of a unit, or may be inserted by a user or technician.Attorney Docket No: TMTTMT-23254WO01

[0357] The snares 642 may comprise relatively stiff wires for passage through the eyelets 644. In some implementations, the snares 642 may comprise flexible sutures or filaments or may have another configuration as desired. The snares 642 may be made of nitinol or another form of shape memory material in some implementations.

[0358] One or more of the snares 642 may couple to a tab 646. The tab 646 may comprise a gripping tab for grip by a user or a tool in some implementations. In some implementations, a plurality of the snares 642 may couple to a single tab (e.g., three snares 642 as shown in FIG. 80A). A plurality of the tabs 646 and snares 642 may be provided for the desired number of eyelets. In some implementations, all of the snares 642 utilized may couple to a single tab 646.

[0359] The snares 642 may engage with the coupling tethers 648 (marked in FIG. 80B) of the tether assembly and may be pulled through the eyelets 644 to thereby thread the coupling tethers 648 through the eyelets 644. The tab 646 may be gripped to pull the coupling tethers 648 through the eyelets 644. The loop portions 650 of the respective coupling tethers 648 may be accessible for a user or technician to thread a release tether therethrough.

[0360] In some implementations, a packaging for the implant 162, or a packaging for the delivery system, can include mating features for aligning the insertion of the coupling tethers 648 into the snares 642. Such a feature may improve the ease in which the coupling tethers 648 are joined with the snares 642. All of the coupling tethers 648 may be joined with all of the snares 642 simultaneously in such an implementation, rather than one-by-one manual insertion.

[0361] In some implementations, the snares may be configured to aid in expanding the loop portions 650 of the coupling tethers 648. FIG. 81 illustrates a variation of a snare 660 that includes expandable arms 662a, b for expanding a respective loop portion 650. The arms 662a, b may include an opening 664 or cut-out portion that allows for the loop portion 650 to enter a loop 666 formed by the arms 662a, b. The arms 662a, b may then be threaded through the eyelet 644 to pull the loop portion 650 therethrough. The arms 662a, b may then deflect away from each other to expand the size of the loop portion 650 for receiving a release tether.

[0362] FIGS. 82A-82C illustrate a variation in which a snare 670 extends through multiple of the eyelets 644. The snare 670 may comprise an elongate body that may be passed or woven through a desired number of eyelets 644 (e.g., two eyelets, or three eyelets, or a greater number of eyelets). The elongate body may be woven through all eyelets 644 in some implementations. TheAttorney Docket No: TMTTMT-23254WO01 snare 670 may be pre-attached with the device or implant as part of a unit, or may be attached by a user or technician.

[0363] An end portion 672 of the snare 670 may include a connecting member 674 in the form of a hook or another form of connecting member. The connecting member 674 may couple to a loop portion 650 of a coupling tether 648 (as shown in FIG. 82B) and may pull the loop portion 650 through an eyelet 644 (as shown in FIG. 82C). The loop portion 650 may release from the connecting member 674. Another loop portion of a different coupling tether may join with the connecting member 674 and be pulled through an adjacent eyelet 644. The process may continue until the desired number of coupling tethers are attached to the device or implant. A single snare 670 may be utilized or multiple snares 670 may be utilized as desired. For example, multiple snares may be pre-attached with the device or implant as part of a unit and passing through different sets of eyelets 644 (or multiple snares may be utilized by a user or technician in some implementations) .

[0364] In some implementations, a release tether threading device may be utilized to thread the release tethers through one or more of the loop portions 650. FIG. 83, for example, illustrates an example of a release tether threading device 680 including a collet 682 for engaging a release tether 684. The release tether threading device 680 may have a body 686 coupled to the collet 682 that may pass through multiple of the loop portions 650. The collet 682 may attach to the release tether 684 and may be pulled through the loop portions 650 to draw the release tether 684 through the loop portions 650. Other configurations of release tether threading devices may be utilized in some implementations.

[0365] Features of FIGS. 80A-83 may be utilized solely or in combination with any other example disclosed herein.

[0366] Other methods of attachment of a tether assembly to a device or implant may be utilized in some implementations. FIGS. 84A-E illustrate examples of eyelets 690a-690e having openings or cut-out portions in the side arms of the eyelets 690a-690e that may allow a tether assembly to pass therethrough to be received in a central opening 692a-692e of the respective eyelet 690a-690e. The openings in the side arms may be cut to reduce the possibility of the tether assembly from releasing from the respective eyelet 690a-690e after being attached to the eyelet. Angled paths, curved paths, or paths varying in direction may be provided for the openings or cutout portions in the side arms of the eyelets 690a-690e. The eyelets 690a-690e may be utilizedAttorney Docket No: TMTTMT-23254WO01 with a tether threading device for threading the tether assembly through the plurality of eyelets in implementations, or may be utilized without such a tether threading device.

[0367] Features of FIGS. 84A-84E may be utilized solely or in combination with any other example disclosed herein.

[0368] FIGS. 85-87 illustrate an exemplary device, implant, or prosthetic valve that may be implanted in a body using delivery systems and / or features described herein. Additional details of systems, devices, implants, prosthetic valves, etc. that may be utilized are disclosed in International Application No. PCT / US2023 / 085397, with an international filing date of December 21, 2023, and published as WO / 2024 / 145164, and titled “DELIVERY SYSTEMS AND TETHER ASSEMBLIES FOR PROSTHETIC VALVES”; and International Application No. PCT / US2023 / 085391, with an international filing date of December 21, 2023, and published as WO / 2024 / 145160 and titled “PROSTHETIC VALVE”; the entire contents of each of which are hereby incorporated by reference for all purposes.

[0369] FIG. 85 illustrates a perspective view of a prosthetic valve 1280 that may be utilized in any example herein. The device or implant 162 as disclosed herein may include the features of the prosthetic valve 1280. The prosthetic valve 1280 may include the features of any other device, prosthetic valve, implant, or example disclosed herein.

[0370] The device or prosthetic valve 1280 includes one or more prosthetic valve leaflets 1282. The prosthetic valve leaflets 1282 may be positioned within a flow channel 1284 of the prosthetic valve 1280. The prosthetic valve leaflets 1282 are supported by a valve body 1286 and may extend radially inward from the valve body 1286 in the flow channel 1284. The prosthetic valve leaflets 1282 are disposed within a lumen of the valve body 1286 for allowing one-way flow.

[0371] The valve body 1286 may include an inner body 1288 (marked in FIG. 86) and an outer body 1290. In some implementations, the inner body 1288 and / or outer body 1290 take the form of collapsible and re-expandable metallic frames. In some implementations, one or more frames may comprise a self-expanding frame, which may be made of a shape memory material (e.g., nitinol). In some implementations, one or more frames may be balloon expandable. In some implementations, one or more frames may be mechanically expandable. The inner body 1288 may include the features of other examples of inner bodies disclosed herein unless stated otherwise. The inner body 1288 may include an inner frame 1292 (marked in FIG. 87). The inner frame 1292 supports the prosthetic valve leaflets 1282. The inner frame 1292 may include a plurality of strutsAttorney Docket No: TMTTMT-23254WO01 that may be separated by spaces or openings. The struts are preferably arranged to form rows of connected cells.

[0372] The outer body 1290 may comprise a sealing body, and may include an outer frame 1306 (marked in FIG. 87) and a sealing skirt 1308, outer skirt, or fabric skirt positioned upon the outer frame 1306. The outer frame 1306 is positioned radially outward of the inner frame 1292. An outer surface 1307 of the outer frame 1306 faces radially outward from the prosthetic valve 1280. The outer surface 1307 is for pressing against tissue of the native heart valve. The sealing skirt 1308 extends along the outer surface 1307 of the outer frame 1306.

[0373] A proximal end portion 1314 of the outer frame 1306 may be coupled to a proximal end portion 1299 of the inner frame 1292.

[0374] In some implementations, the outer frame 1306 has a tapered shape such that a downstream portion, outflow end portion, or distal end portion 1316 has a smaller diameter than an intermediate portion 1322 of the outer frame 1306. The intermediate portion 1322, for example, may have a diameter in a range of about 35 millimeters to about 60 millimeters, with the distal end portion 1316 having a lesser diameter.

[0375] The outer frame 1306 may include one or more grip features 1173 (marked in FIG. 85) disposed along the outer surface. Features of the grip features are disclosed in International Application No. PCT / US2023 / 085397, with an international filing date of December 21, 2023, and published as WO / 2024 / 145164, and titled “DELIVERY SYSTEMS AND TETHER ASSEMBLIES FOR PROSTHETIC VALVES”; and International Application No. PCT / US2023 / 085391, with an international filing date of December 21, 2023, and published as WO / 2024 / 145160 and titled “PROSTHETIC VALVE”: the entire contents of each of which are hereby incorporated by reference for all purposes. The grip features may comprise barbs (or may have any other form capable of engaging surround tissue). The barbs are preferably disposed along the stmts of the outer frame 1306. The barbs may extend through the sealing skirt 1308 for penetrating the tissue of the native heart valve.

[0376] The anchors 1304 are shaped for placement behind native valve leaflets. The anchors may be formed with hook shapes or may be hook arm anchors or ventricular anchors. The anchors 1304 may include the features of any other anchors disclosed herein. The anchors 1304 may be coupled to the distal end portion 1300 of the inner frame 1292. The anchors 1304 are adapted to hook over (i.e., extend around) a native valve leaflet to help anchor the prosthetic valveAttorney Docket No: TMTTMT-23254WO01 within the native valve. The capsule of the delivery system may retract to allow the anchors 1304 to rotate in position to press the native valve leaflets against the outer frame 1306.

[0377] The outer frame 1306 may include one or more couplers 1399 in the form of eyelets or suture eyelets for coupling with the tether assemblies as disclosed herein. Tether assemblies may pass through the eyelets as disclosed herein. Nine eyelets or couplers 1399 are described in some implementations; however, a greater or lesser number may be utilized as desired. The couplers 1399 may be positioned at an inlet end portion or inflow end portion of the prosthetic valve 1280. The couplers 1399 may be positioned at strut arm ends or tabs of the frame of the prosthetic valve 1280.

[0378] The device or prosthetic valve 1280 may be expanded at a treatment or implantation site and released from the delivery system utilizing any of the methods disclosed herein. The frames of the device or prosthetic valve 1280 may be expandable (e.g., self-expandable, balloon expandable, mechanically expandable, etc.). In some implementations, the frame may be made of a shape memory material (e.g., nitinol) in some implementations. Other materials may be utilized in some implementations. The device or prosthetic valve 1280 may be adapted to be restrained in a compressed configuration and then released to expand (e.g., self-expand, etc.) at a treatment or implantation site.

[0379] The examples of devices or prosthetic valves may be utilized in a tricuspid valve as disclosed herein or may be utilized in other deployment locations such as a native mitral valve, or other deployment locations. The device or prosthetic heart valve may comprise a prosthetic atrioventricular’ valve in some implementations. Deployment to aortic or pulmonary valves, or other treatment or implantation sites are also contemplated and are considered to be within the scope of the present disclosure.

[0380] The delivery systems disclosed herein may be utilized with any example disclosed herein.

[0381] Various modifications of the examples disclosed herein may be provided. Features of examples may be modified, substituted, excluded, or combined across examples as desired. Combinations of features across examples may be provided as desired. Combinations of features may be provided across examples with other features of such examples being excluded if desired.Attorney Docket No: TMTTMT-23254WO01

[0382] The various examples of sealing skirts disclosed herein may have a variety of forms, including cloth skirts, foam skirts, or braided skirts as desired. Various materials may be utilized as desired.

[0383] The devices or implants disclosed herein may include prosthetic heart valves or other forms of devices or implants, such as stents, filters, repair devices, diagnostic devices, etc. The devices or implants may be expandable devices or implants configured to move from a compressed or undeployed state to an expanded or deployed state. The devices or implants may be compressible devices / implants configured to be compressed inward to have a reduced outer profile and to move the device or implant to the compressed or undeployed state.

[0384] Various forms of delivery apparatuses may be utilized with the examples disclosed herein. The delivery apparatuses as disclosed herein may be utilized for aortic, mitral, tricuspid, and pulmonary replacement and repair as well. The delivery apparatuses may comprise delivery apparatuses for delivery of other forms of devices or implants, such as stents, filters, repair devices, diagnostic devices, etc.

[0385] The devices, implants, and systems disclosed herein may be used in transcatheter mitral or tricuspid treatment or implantation, as well as transcatheter aortic valve replacement (TAVR) or treatment or replacement of other native heart valves (e.g., pulmonary valves). The delivery apparatuses and the systems disclosed herein may be utilized for transarterial access, including transfemoral access, to a subject’s heart. When used for transcatheter mitral valve replacement, the delivery procedure is preferably performed using a transseptal delivery technique wherein the delivery catheter is advanced into the right atrium, through a hole in the septum and then into the left atrium for accessing the native mitral valve. The delivery apparatuses and systems may also be utilized in other transcatheter percutaneous procedures, including transarterial procedures, which may be transfemoral or transjugular. Transapical procedures, among others, may also be utilized. Other procedures may be utilized as desired.

[0386] Any of the various systems, assemblies, devices, components, apparatuses, etc. in this disclosure (including in the examples below) 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 comprise or consist of) sterilization of the associated system, device, component, apparatus, etc. (e.g., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.).Attorney Docket No: TMTTMT-23254WO01

[0387] The techniques, methods, processes, operations, steps, etc. described or suggested herein (including in the examples below) or in the references incorporated herein, and any methods of using the systems, assemblies, apparatuses, devices, etc. herein, can be performed on a living subject (e.g., human, other animal, etc.) or on a simulation (e.g., a cadaver, cadaver heart, simulator, imaginary person, etc.). When performed on a simulation, the body parts, e.g., heart, tissue, valve, etc., can be assumed to be simulated or can optionally be referred to as “simulated” (e.g., simulated heart, simulated tissue, simulated valve, etc.) and can optionally comprise computerized and / or physical representations of body pails, tissue, etc. The term “simulation” covers use on a cadaver, computer simulator, imaginary person (e.g., if they are just demonstrating in the air on an imaginary heart), etc.

[0388] In addition, the methods, techniques, processes, operations, steps, etc. herein are not limited to the methods specifically described and may include methods of utilizing the systems and apparatuses disclosed herein. The steps of the methods may be modified, excluded, or added to, with systems, apparatuses, and methods disclosed herein. The examples disclosed herein may comprise systems for treatment or implantation within a human body in some implementations.

[0389] For purposes of this description, certain aspects, advantages, and novel features of the examples of this disclosure are described herein. The disclosed methods, apparatuses, and systems should not be construed as limiting in any way. Instead, the present disclosure is directed toward all novel and nonobvious features and aspects of the various disclosed examples, along and in various combinations and sub-combinations with one another. The methods, apparatuses, and systems are not limited to any specific aspect or feature or combination thereof, nor do the disclosed examples require that any one or more specific advantages be present or problems be solved. Features, elements, or combinations of one example can be combined into other examples herein.

[0390] Example 1: A delivery system for a device, the delivery system comprising: a delivery catheter having an elongate shaft for advancing the device through a subject’s vasculature to a treatment or implantation site; and a unit including: the device, the device having a frame, and / or a tether assembly coupled to at least a portion of the device, the tether assembly adapted to be attached to the delivery catheter.Attorney Docket No: TMTTMT-23254WO01

[0391] Example 2: The delivery system of any example herein, in particular Example 1 , wherein the device includes a plurality of eyelets, and the tether assembly extends through the plurality of eyelets.

[0392] Example 3: The delivery system of any example herein, in particular Example 1 or Example 2, wherein the tether assembly includes a first end portion and a second end portion, the first end portion being coupled to at least the portion of the device and the second end portion comprises a free end of the tether assembly.

[0393] Example 4: The delivery system of any example herein, in particular Examples 1- 3, wherein the tether assembly includes a plurality of coupling tethers and a manifold joining the plurality of coupling tethers.

[0394] Example 5: The delivery system of any example herein, in particular Example 4, wherein the device includes a plurality of eyelets, and the plurality of coupling tethers each include a loop portion extending through a respective one of the plurality of eyelets.

[0395] Example 6: The delivery system of any example herein, in particular Examples 1-5, wherein the device is configured as a prosthetic heart valve that includes a plurality of leaflets disposed within a lumen of the frame for allowing one-way flow of blood.

[0396] Example 7: The delivery system of any example herein, in particular Examples 1-6, wherein the delivery catheter includes an actuator assembly for controlling release of the device from the elongate shaft, and the tether assembly is adapted to be attached to the actuator assembly.

[0397] Example 8: The delivery system of any example herein, in particular Examples 1-7, wherein the elongate shaft includes an interior lumen, and the tether assembly of the unit includes at least a portion of a flexible retention tether adapted to extend through the interior lumen of the elongate shaft and adapted to control release of the device from the elongate shaft.

[0398] Example 9: The delivery system of any example herein, in particular Example 8, wherein the delivery catheter includes an actuator assembly for controlling release of the device from the elongate shaft, and the flexible retention tether is adapted to engage the actuator assembly.

[0399] Example 10: The delivery system of any example herein, in particular- Example 9, further comprising a snare assembly adapted to engage the flexible retention tether and retract the flexible retention tether axially within the interior lumen.Attorney Docket No: TMTTMT-23254WO01

[0400] Example 1 1 : The delivery system of any example herein, in particular Example 10, further comprising a release mechanism for automatically disengaging the snare assembly from the flexible retention tether.

[0401] Example 12: The delivery system of any example herein, in particular Examples 1-11, wherein the elongate shaft includes an interior lumen, and wherein the unit further comprises a first section of a flexible retention tether, the first section having a proximal end portion, and the delivery system further comprises: a second section of the flexible retention tether adapted to extend within the interior lumen of the elongate shaft, the second section having a distal end portion; and a connector for connecting the proximal end portion of the first section of the flexible retention tether of the unit to the distal end portion of the second section of the flexible retention tether, and wherein the flexible retention tether is adapted to control release of the device from the elongate shaft.

[0402] Example 13: The delivery system of any example herein, in particular’ Example 12, further comprising a snare assembly adapted to engage the second section of the flexible retention tether and retract the second section axially within the interior lumen.

[0403] Example 14: The delivery system of any example herein, in particular’ Example 13, wherein the interior lumen includes a distal end having an opening, and the snare assembly is adapted to retract the flexible retention tether axially within the interior lumen such that the connector proximally enters the opening of the distal end.

[0404] Example 15: The delivery system of any example herein, in particular Examples 12-14, wherein the delivery catheter includes an actuator assembly for controlling release of the device from the elongate shaft, and the second section of the flexible retention tether is adapted to engage the actuator assembly.

[0405] Example 16: The delivery system of any example herein, in particular’ Example 15, wherein the second section of the flexible retention tether is engaged with the actuator assembly.

[0406] Example 17: The delivery system of any example herein, in particular Example 15 or Example 16, wherein the actuator assembly is adapted to axially advance or axially retract the flexible retention tether within the interior lumen to control release of the device from the elongate shaft.Attorney Docket No: TMTTMT-23254WO01

[0407] Example 18: The delivery system of any example herein, in particular Examples 12-17, wherein the second section of the flexible retention tether has an axial stiffness to transmit an axially proximal force to the tether assembly and an axially distal force to the tether assembly.

[0408] Example 19: The delivery system of any example herein, in particular Example 18, wherein the second section of the flexible retention tether is a wire.

[0409] Example 20: The delivery system of any example herein, in particular Examples 12-19, wherein the connector is a mechanical snap connector.

[0410] Example 21: The delivery system of any example herein, in particular' Examples 12-20, wherein the connector is adapted to transmit an axially proximal force to the tether assembly and an axially distal force to the tether assembly.

[0411] Example 22: The delivery system of any example herein, in particular Examples 12-21, wherein the connector is one or more of a knot, a wire loop for engaging a plug, a cam body for engaging a loop, or a cinch body.

[0412] Example 23: The delivery system of any example herein, in particular Examples 1-22, wherein the unit further comprises a release assembly securing the tether assembly to at least the portion of the device.

[0413] Example 24: The delivery system of any example herein, in particular Example 23, wherein the device includes a plurality of eyelets, and the tether assembly includes a plurality of coupling tethers each including a loop portion extending through a respective one of the plurality of eyelets, and the release assembly includes one or more release tethers extending through the loop portions to secure the tether assembly to at least the portion of the device.

[0414] Example 25 : The delivery system of any example herein, in particular Example 24, further comprising a locking device for impeding the one more release tethers from being withdrawn from the loop portions.

[0415] Example 26: The delivery system of any example herein, in particular Example 24 or Example 25, wherein the unit further comprises a plurality of the release tethers and a manifold joining the plurality of release tethers.

[0416] Example 27: The delivery system of any example herein, in particular Examples 24-26, wherein the delivery catheter includes an actuator assembly for controlling actuation of the release assembly, and wherein the release assembly of the unit includes at least a portion of aAttorney Docket No: TMTTMT-23254WO01 retractable tether coupled to the one or more release tethers, and wherein the retractable tether is adapted to engage the actuator assembly.

[0417] Example 28: The delivery system of any example herein, in particular Example 27, wherein the elongate shaft includes an interior lumen, and the delivery system further comprises a snare assembly adapted to engage the retractable tether and retract the retractable tether within the interior lumen.

[0418] Example 29: The delivery system of any example herein, in particular Example 27 or Example 28, wherein the elongate shaft includes an interior lumen, and wherein the unit further comprises a first section of the retractable tether, the first section having a proximal end portion, and the delivery system further comprises: a second section of the retractable tether adapted to extend within the interior lumen of the elongate shaft, the second section having a distal end portion; and a connector for connecting the proximal end portion of the first section of the retractable tether of the unit to the distal end portion of the second section of the retractable tether.

[0419] Example 30: The delivery system of any example herein, in particular Example 29, wherein the second section of the retractable tether is engaged with the actuator assembly.

[0420] Example 31: The delivery system of any example herein, in particular Examples 27-30, wherein the elongate shaft includes an interior lumen, and the tether assembly of the unit includes at least a portion of a flexible retention tether adapted to extend through the interior lumen of the elongate shaft and adapted to control release of the device from the elongate shaft, and the delivery system further comprises an elongate partition in the elongate shaft for separating the retractable tether from the flexible retention tether.

[0421] Example 32: The delivery system of any example herein, in particular’ Examples 1-31, further comprising an alignment sheath for extending within the lumen of the frame, the alignment sheath for receiving an alignment wire extending from the elongate shaft of the delivery catheter.

[0422] Example 33: The delivery system of any example herein, in particular Example 32, wherein the unit includes the alignment sheath.

[0423] Example 34: The delivery system of any example herein, in particular Examples 1-33, wherein the device includes a plurality of eyelets, and the tether assembly comprises a ring extending through the plurality of eyelets, and the delivery system further comprises one or more hooks for engaging the ring.Attorney Docket No: TMTTMT-23254WO01

[0424] Example 35: The delivery system of any example herein, in particular Examples 1-34, wherein the device is a prosthetic atrioventricular valve, and the treatment or implantation site is a native atrioventricular valve.

[0425] Example 36: A medical system comprising: a unit including: a device having a frame, and a tether assembly coupled to at least a portion of the device, the tether assembly being for connection with a delivery catheter to thereby couple the unit to the delivery catheter.

[0426] Example 37 : The system of any example herein, in particular Example 36, wherein the device includes a plurality of eyelets, and the tether assembly extends through the plurality of eyelets.

[0427] Example 38: The system of any example herein, in particular’ Example 36 or Example 37, wherein the tether assembly includes a first end portion and a second end portion, the first end portion being coupled to at least the portion of the device and the second end portion comprising a free end of the tether assembly.

[0428] Example 39: The system of any example herein, in particular Examples 36-38, wherein the tether assembly includes a plurality of coupling tethers and a manifold joining the plurality of coupling tethers.

[0429] Example 40: The system of any example herein, in particular Example 39, wherein the device includes a plurality of eyelets, and the plurality of coupling tethers each include a loop portion extending through a respective one of the plurality of eyelets.

[0430] Example 41: The system of any example herein, in particular Examples 36-40, wherein the unit further comprises a release assembly including one or more release tethers securing the tether assembly to at least the portion of the device.

[0431] Example 42: The system of any example herein, in particular Example 41, wherein the device includes a plurality of eyelets, and the tether assembly includes a plurality of coupling tethers each including a loop portion extending through a respective one of the plurality of eyelets, and the one or more release tethers extend through the loop portions to secure the tether assembly to at least the portion of the device.

[0432] Example 43: The system of any example herein, in particular Example 42, wherein the release assembly include a first end portion and a second end portion, the first end portion including the one or more release tethers extending through the loop portions, and the second end portion comprising a free end of the release assembly.Attorney Docket No: TMTTMT-23254WO01

[0433] Example 44: The system of any example herein, in particular Examples 36-43, wherein the unit further comprises an alignment sheath extending within the lumen of the frame, the alignment sheath for receiving an alignment wire extending from the delivery catheter.

[0434] Example 45: The system of any example herein, in particular Examples 36-44, wherein the device is a prosthetic atrioventricular valve comprising a plurality of leaflets disposed within a lumen of the frame for allowing one-way flow of blood.

[0435] Example 46: A medical system comprising: a device having a frame and a plurality of eyelets; a tether assembly adapted to couple to the plurality of eyelets, the tether assembly adapted to couple the device to a delivery catheter; and a tether threading device for threading the tether assembly through the plurality of eyelets.

[0436] Example 47: The medical system of any example herein, in particular Example 46, wherein the tether threading device comprises at least one snare adapted to extend through at least one of the plurality of eyelets.

[0437] Example 48: The medical system of any example herein, in particular Example 47, wherein the at least one snare is adapted to extend through multiple of the eyelets.

[0438] Example 49: The medical system of any example herein, in particular Example 47 or Example 48, wherein the tether threading device includes a tab coupled to the at least one snare.

[0439] Example 50: The medical system of any example herein, in particular Examples 46-49, wherein the tether assembly includes a plurality of coupling tethers each including a loop portion adapted to extend through a respective one of the plurality of eyelets.

[0440] Example 51 : The medical system of any example herein, in particular Example 50, wherein the tether threading device comprises at least one snare adapted to extend through at least one of the plurality of eyelets and engage the loop portion, the at least one snare including expandable arms adapted to expand the loop portion.

[0441] Example 52: The medical system of any example herein, in particular Example 50 or Example 51, further comprising a release assembly for securing the tether assembly to the plurality of eyelets, and the release assembly includes one or more release tethers for extending through the loop portions to secure the tether assembly to the plurality of eyelets.

[0442] Example 53: The medical system of any example herein, in particular Example 52, further comprising a release tether threading device for threading the one or more release tethers through the loop portions.Attorney Docket No: TMTTMT-23254WO01

[0443] Example 54: The medical system of any example herein, in particular Example 53, wherein the release tether threading device includes a collet.

[0444] Example 55: The medical system of any example herein, in particular- Examples 46-54, wherein the plurality of eyelets have openings in side arms of the eyelets.

[0445] Example 56: The medical system of any example herein, in particular Examples 46-55, wherein the device is a prosthetic atrioventricular valve comprising a plurality of leaflets disposed within a lumen of the frame for allowing one-way flow of blood.

[0446] Example 57: A method comprising: providing a delivery catheter having an elongate shaft for advancing a device through vasculature of a subject to a treatment or implantation site; providing a unit including: the device having a frame, and a tether assembly coupled to at least a portion of the device; and attaching the tether assembly to the delivery catheter.

[0447] Example 58: The method of any example herein, in particular Example 57, wherein attaching the tether assembly to the delivery catheter includes attaching a first section of a flexible retention tether of the unit to a second section of the flexible retention tether extending with an interior lumen of the elongate shaft.

[0448] Example 59: The method of any example herein, in particular- Example 58, further comprising retracting the second section of the flexible retention tether through the interior lumen of the elongate shaft utilizing a snare assembly.

[0449] Example 60: The method of any example herein, in particular- Example 58 or Example 59, further comprising engaging the second section of the flexible retention tether with an actuator assembly for controlling release of the device from the elongate shaft.

[0450] Example 61: The method of any example herein, in particular Examples 57-60, wherein the tether assembly includes a plurality of coupling tethers, and a flexible retention tether couples the plurality of coupling tethers to an actuator assembly for controlling release of the device from the elongate shaft, and the method further comprises: retracting an entirety of the flexible retention tether through an interior lumen of the elongate shaft utilizing a snare assembly; and engaging the flexible retention tether with the actuator assembly.

[0451] Example 62: The method of any example herein, in particular Examples 57-61, wherein the device includes a plurality of eyelets, and the tether assembly includes a plurality of coupling tethers each including a loop portion extending through a respective one of the plurality of eyelets, and the unit further comprises a release assembly including one or more release tethersAttorney Docket No: TMTTMT-23254WO01 extending through the loop portions to secure the tether assembly to at least the portion of the device.

[0452] Example 63: The method of any example herein, in particular Example 62, further comprising attaching the release assembly to the delivery catheter.

[0453] Example 64: The method of any example herein, in particular Example 63, wherein attaching the release assembly to the delivery catheter includes attaching a first section of a retractable tether of the unit to a second section of the retractable tether extending with an interior lumen of the elongate shaft.

[0454] Example 65: The method of any example herein, in particular Example 64, further comprising retracting the second section of the retractable tether through the interior lumen of the elongate shaft utilizing a snare assembly.

[0455] Example 66: The method of any example herein, in particular Examples 57-65, wherein the device is a prosthetic atrioventricular valve comprising a plurality of leaflets disposed within a lumen of the frame for allowing one-way flow of blood, and the treatment or implantation site is a native atrioventricular valve.

[0456] Example 67: A method comprising: providing a device having a frame, the device including a plurality of eyelets; providing a tether assembly adapted to couple to the plurality of eyelets, the tether assembly adapted to couple the device to a delivery catheter; and / or utilizing a tether threading device to thread the tether assembly through the plurality of eyelets.

[0457] Example 68: The method of any example herein, in particular Example 67, wherein the tether threading device comprises at least one snare adapted to extend through at least one of the plurality of eyelets.

[0458] Example 69: The method of any example herein, in particular Example 68, wherein the at least one snare is adapted to extend through multiple of the eyelets.

[0459] Example 70: The method of any example herein, in particular- Example 68 or Example 69, wherein the tether threading device includes a tab coupled to the at least one snare.

[0460] Example 71: The method of any example herein, in particular Examples 67-70, wherein the tether assembly includes a plurality of coupling tethers each including a loop portion adapted to extend through a respective one of the plurality of eyelets.

[0461] Example 72: The method of any example herein, in particular- Example 71 , wherein the tether threading device comprises at least one snare adapted to extend through at least one ofAttorney Docket No: TMTTMT-23254WO01 the plurality of eyelets and engage the loop portion, the at least one snare including expandable arms adapted to expand the loop portion.

[0462] Example 73: The method of any example herein, in particular Example 71 or Example 72, further comprising providing a release assembly for securing the tether assembly to the plurality of eyelets, the release assembly including one or more release tethers for extending through the loop portions to secure the tether assembly to the plurality of eyelets, and the method further comprises threading the one or more release tethers through the loop portions utilizing a release tether threading device.

[0463] Example 74: The method of any example herein, in particular Example 73, wherein the release tether threading device includes a collet.

[0464] Example 75: The method of any example herein, in particular Examples 67-74, wherein the tether assembly is attached to a delivery catheter having an elongate shaft for advancing the device through a subject’s vasculature to a treatment or implantation site.

[0465] Example 76: The method of any example herein, in particular Examples 67-75, wherein the device is a prosthetic atrioventricular valve comprising a plurality of leaflets disposed within a lumen of the frame for allowing one-way flow of blood and is adapted to be deployed to a native atrioventricular valve.

[0466] Example 77. A method comprising: providing a unit including: a device having a frame, a tether assembly, and a release assembly securing the tether assembly to at least a portion of the device; providing a delivery catheter including: an elongate shaft for advancing the device through vasculature of a subject to a treatment or implantation site, and an elongate partition positioned in the elongate shaft and configured for at least a portion of the tether assembly to extend through and at least a portion of the release assembly to extend through and configured to separate the portion of the tether assembly from the portion of the release assembly; and / or advancing a snare assembly distally through the elongate partition for reconnection with the tether assembly or the release assembly, the snare assembly having previously lost a connection with the respective tether assembly or the release assembly within the delivery catheter.

[0467] Any of the features of any of the examples, including but not limited to any of the first through 77 examples referred to above, is applicable to all other aspects and examples identified herein, including but not limited to any examples of any of the first through 77 examples referred to above. Moreover, any of the features of an example of the various examples, includingAttorney Docket No: TMTTMT-23254WO01 but not limited to any examples of any of the first through 77 examples referred to above, is independently combinable, partly or wholly with other examples described herein in any way, c.g., one, two, or three or more examples may be combinable in whole or in pail. Further, any of the features of the various examples, including but not limited to any examples of any of the first through 77 examples referred to above, may be made optional to other examples. Any example of a method can be performed by a system or apparatus of another example, and any aspect or example of a system or apparatus can be configured to perform a method of another aspect or example, including but not limited to any examples of any of the first through 77 examples referred to above.

[0468] In closing, it is to be understood that although aspects of the present specification are highlighted by referring to specific examples, one skilled in the art will readily appreciate that these disclosed examples are only illustrative of the principles of the subject matter disclosed herein. Therefore, it should be understood that the disclosed subject matter is in no way limited to a particular methodology, protocol, and / or reagent, etc., described herein. As such, various modifications or changes to or alternative configurations of the disclosed subject matter can be made in accordance with the teachings herein without departing from the spirit of the present specification. Lastly, the terminology used herein is for the purpose of describing particular examples only, and is not intended to limit the scope of systems, apparatuses, and methods as disclosed herein, which is defined solely by the claims. Accordingly, the systems, apparatuses, and methods are not limited to that precisely as shown and described.

[0469] Certain some implementations of systems, apparatuses, and methods are described herein, including the best mode known to the inventors for carrying out the same. Of course, variations on these described examples will become apparent to those of ordinary skill in the art upon reading the foregoing description. The inventor expects skilled artisans to employ such variations as appropriate, and the inventors intend for the systems, apparatuses, and methods to be practiced otherwise than specifically described herein. The systems, apparatuses, and methods include all modifications and equivalents of subject matter recited in the claims. Any combination of the above-described examples in all possible variations thereof is encompassed by the systems, apparatuses, and methods unless otherwise indicated herein.

[0470] Groupings of alternative examples, elements, or steps of the systems, apparatuses, and methods are not to be construed as limitations. Each group member may be referred to andAttorney Docket No: TMTTMT-23254WO01 claimed individually or in any combination with other group members disclosed herein. It is anticipated that one or more members of a group may be included in, or deleted from, a group for reasons of convenience and / or patentability. When any such inclusion or deletion occurs, the specification is deemed to contain the group as modified thus fulfilling the written description of all Markush groups used in the appended claims.

[0471] Unless otherwise indicated, all numbers expressing a characteristic, item, quantity, parameter, property, term, and so forth used in the present specification and claims are to be understood as being modified in all instances by the term “about.” As used herein, the term “about” means that the characteristic, item, quantity, parameter, property, or term so qualified encompasses an approximation that may vary, yet is capable of performing the desired operation or process discussed herein.

[0472] The terms “a,” “an,” “the” and similar referents used in the context of describing the systems, apparatuses, and methods (especially in the context of the following claims) are to be construed to cover both the singular and the plural, unless otherwise indicated herein or clearly contradicted by context. All methods described herein can be performed in any suitable order unless otherwise indicated herein or otherwise clearly contradicted by context. The use of any and all examples, or exemplary language (e.g., “such as”) provided herein is intended merely to better illuminate the systems, apparatuses, and methods and does not pose a limitation on the scope of the systems, apparatuses, and methods otherwise claimed. Nothing in this specification should be construed as indicating any non-claimed element is essential to the claimed inventions.

[0473] All patents, patent publications, and other publications referenced and identified in the present specification are individually and expressly incorporated herein by reference in their entirety for the purpose of describing and disclosing, for example, the compositions and methodologies described in such publications that might be used in connection with the systems, apparatuses, and methods. These publications are provided solely for their disclosure prior to the filing date of the present application. Nothing in this regal’d should be construed as an admission that the inventors are not entitled to antedate such disclosure by virtue of prior invention or for any other reason. All statements as to the date or representation as to the contents of these documents is based on the information available to the applicants and does not constitute any admission as to the correctness of the dates or contents of these documents.

Claims

Attorney Docket No: TMTTMT-23254WO01WHAT TS CLAIMED TS:

1. A delivery system for a device, the delivery system comprising: a delivery catheter having an elongate shaft for advancing the device through a subject’s vasculature to a treatment or implantation site; and a unit including: the device, the device having a frame, and a tether assembly coupled to at least a portion of the device, the tether assembly adapted to be attached to the delivery catheter.

2. The delivery system of claim 1, wherein the device includes a plurality of eyelets, and the tether assembly extends through the plurality of eyelets.

3. The delivery system of claim 1 or claim 2, wherein the tether assembly includes a first end portion and a second end portion, the first end portion being coupled to at least the portion of the device and the second end portion comprises a free end of the tether assembly.

4. The delivery system of any of claims 1-3, wherein the tether assembly includes a plurality of coupling tethers and a manifold joining the plurality of coupling tethers.

5. The delivery system of claim 4, wherein the device includes a plurality of eyelets, and the plurality of coupling tethers each include a loop portion extending through a respective one of the plurality of eyelets.

6. The delivery system of any of claims 1-5, wherein the device is configured as a prosthetic heart valve that includes a plurality of leaflets disposed within a lumen of the frame for allowing oneway flow of blood.

7. The delivery system of any of claims 1-6, wherein the delivery catheter includes an actuator assembly for controlling release of the device from the elongate shaft, and the tether assembly is adapted to be attached to the actuator assembly.Attorney Docket No: TMTTMT-23254WO018. The delivery system of any of claims 1-7, wherein the elongate shaft includes an interior lumen, and the tether assembly of the unit includes at least a portion of a flexible retention tether adapted to extend through the interior lumen of the elongate shaft and adapted to control release of the device from the elongate shaft.

9. The delivery system of claim 8, wherein the delivery catheter includes an actuator assembly for controlling release of the device from the elongate shaft, and the flexible retention tether is adapted to engage the actuator assembly.

10. The delivery system of claim 9, further comprising a snare assembly adapted to engage the flexible retention tether and retract the flexible retention tether axially within the interior lumen.

11. The delivery system of claim 10, further comprising a release mechanism for automatically disengaging the snare assembly from the flexible retention tether.

12. The delivery system of any of claims 1-11, wherein the elongate shaft includes an interior lumen, and wherein the unit further comprises a first section of a flexible retention tether, the first section having a proximal end portion, and the delivery system further comprises: a second section of the flexible retention tether adapted to extend within the interior lumen of the elongate shaft, the second section having a distal end portion; and a connector for connecting the proximal end portion of the first section of the flexible retention tether of the unit to the distal end portion of the second section of the flexible retention tether, and wherein the flexible retention tether is adapted to control release of the device from the elongate shaft.

13. The delivery system of claim 12, wherein the delivery catheter includes an actuator assembly for controlling release of the device from the elongate shaft, and the second section of the flexible retention tether is adapted to engage the actuator assembly.Attorney Docket No: TMTTMT-23254WO0114. The delivery system of claim 12 or claim 13, wherein the connector is a mechanical snap connector.

15. The delivery system of any of claims 12-14, wherein the connector is one or more of a knot, a wire loop for engaging a plug, a cam body for engaging a loop, or a cinch body.

16. The delivery system of any of claims 1-15, wherein the unit further comprises a release assembly securing the tether assembly to at least the portion of the device.

17. The delivery system of claim 16, wherein the device includes a plurality of eyelets, and the tether assembly includes a plurality of coupling tethers each including a loop portion extending through a respective one of the plurality of eyelets, and the release assembly includes one or more release tethers extending through the loop portions to secure the tether assembly to at least the portion of the device.

18. The delivery system of claim 17, wherein the delivery catheter includes an actuator assembly for controlling actuation of the release assembly, and wherein the release assembly of the unit includes at least a portion of a retractable tether coupled to the one or more release tethers, and wherein the retractable tether is adapted to engage the actuator assembly.

19. The delivery system of claim 18, wherein the elongate shaft includes an interior lumen, and the tether assembly of the unit includes at least a portion of a flexible retention tether adapted to extend through the interior lumen of the elongate shaft and adapted to control release of the device from the elongate shaft, and the delivery system further comprises an elongate partition in the elongate shaft for separating the retractable tether from the flexible retention tether.

20. The delivery system of any of claims 1-19, wherein the device is a prosthetic atrioventricular valve, and the treatment or implantation site is a native atrioventricular valve.Attorney Docket No: TMTTMT-23254WO0121. A medical system comprising: a unit including: a device having a frame, and a tether assembly coupled to at least a portion of the device, the tether assembly being for connection with a delivery catheter to thereby couple the unit to the delivery catheter.

22. The medical system of claim 21, wherein the device includes a plurality of eyelets, and the tether assembly extends through the plurality of eyelets.

23. The medical system of claim 21 or claim 22, wherein the tether assembly includes a first end portion and a second end portion, the first end portion being coupled to at least the portion of the device and the second end portion comprising a free end of the tether assembly.

24. The medical system of any of claims 21-23, wherein the tether assembly includes a plurality of coupling tethers and a manifold joining the plurality of coupling tethers.

25. The medical system of claim 24, wherein the device includes a plurality of eyelets, and the plurality of coupling tethers each include a loop portion extending through a respective one of the plurality of eyelets.

26. The medical system of any of claims 21-25, wherein the unit further comprises a release assembly including one or more release tethers securing the tether assembly to at least the portion of the device.

27. The medical system of claim 26, wherein the device includes a plurality of eyelets, and the tether assembly includes a plurality of coupling tethers each including a loop portion extending through a respective one of the plurality of eyelets, and the one or more release tethers extend through the loop portions to secure the tether assembly to at least the portion of the device.

28. The medical system of claim 27, wherein the release assembly include a first end portion and a second end portion, the first end portion including the one or more release tethers extendingAttorney Docket No: TMTTMT-23254WO01 through the loop portions, and the second end portion comprising a free end of the release assembly.

29. The medical system of any of claims 21-28, wherein the unit further comprises an alignment sheath extending within a lumen of the frame, the alignment sheath for receiving an alignment wire extending from the delivery catheter.

30. The medical system of any of claims 21-29, wherein the device is a prosthetic atrioventricular valve comprising a plurality of leaflets disposed within a lumen of the frame for allowing one-way flow of blood.

31. A medical system comprising: a device having a frame and a plurality of eyelets; a tether assembly adapted to couple to the plurality of eyelets, the tether assembly adapted to couple the device to a delivery catheter; and a tether threading device for threading the tether assembly through the plurality of eyelets.

32. The medical system of claim 31, wherein the tether threading device comprises at least one snare adapted to extend through at least one of the plurality of eyelets.

33. The medical system of claim 32, wherein the at least one snare is adapted to extend through multiple of the eyelets.

34. The medical system of claim 32 or claim 33, wherein the tether threading device includes a tab coupled to the at least one snare.

35. The medical system of any of claims 31-34, wherein the tether assembly includes a plurality of coupling tethers each including a loop portion adapted to extend through a respective one of the plurality of eyelets.Attorney Docket No: TMTTMT-23254WO0136. The medical system of claim 35, wherein the tether threading device comprises at least one snare adapted to extend through at least one of the plurality of eyelets and engage the loop portion, the at least one snare including expandable arms adapted to expand the loop portion.

37. The medical system of claim 35 or claim 36, further comprising a release assembly for securing the tether assembly to the plurality of eyelets, and the release assembly includes one or more release tethers for extending through the loop portions to secure the tether assembly to the plurality of eyelets.

38. The medical system of claim 37, further comprising a release tether threading device for threading the one or more release tethers through the loop portions.

39. The medical system of any of claims 31-38, wherein the plurality of eyelets have openings in side arms of the eyelets.

40. The medical system of any of claims 31-39, wherein the device is a prosthetic atrioventricular valve comprising a plurality of leaflets disposed within a lumen of the frame for allowing one-way flow of blood.

41. A method comprising: providing a delivery catheter having an elongate shaft for advancing a device through vasculature of a subject to a treatment or implantation site; providing a unit including: the device having a frame, and a tether assembly coupled to at least a portion of the device; and attaching the tether assembly to the delivery catheter.

42. A method comprising: providing a device having a frame, the device including a plurality of eyelets; providing a tether assembly adapted to couple to the plurality of eyelets, the tether assembly adapted to couple the device to a delivery catheter; andAttorney Docket No: TMTTMT-23254WO01 utilizing a tether threading device to thread the tether assembly through the plurality of eyelets.

43. A method comprising: providing a unit including: a device having a frame, a tether assembly, and a release assembly securing the tether assembly to at least a portion of the device; providing a delivery catheter including: an elongate shaft for advancing the device through vasculature of a subject to a treatment or implantation site, and an elongate partition positioned in the elongate shaft and configured for at least a portion of the tether assembly to extend through and at least a portion of the release assembly to extend through and configured to separate the portion of the tether assembly from the portion of the release assembly; and advancing a snare assembly distally through the elongate partition for reconnection with the tether assembly or the release assembly, the snare assembly having previously lost a connection with the respective tether assembly or the release assembly within the delivery catheter.

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