Delivery apparatus for a prosthetic device

Abstract

A delivery apparatus for a prosthetic implant includes a handle body, a shaft, and shaft displacement and adjustment mechanisms coupled to the handle body. The shaft displacement mechanism can comprise a carriage configured to translate axially relative to the handle body and coupled to a portion of the shaft. The shaft adjustment mechanism can be configured to adjust a curvature of the shaft and can comprise a pull wire. A first knob and / or other actuating mechanism operatively can be coupled to the shaft displacement mechanism and can be configured to simultaneously axially displace the shaft and the pull wire relative to the handle body. A second knob and / or other actuating mechanism can be operatively coupled to the shaft adjustment mechanism and configured to adjust a curvature of the shaft.

Description

THVDL-13801W001DELIVERY APPARATUS FOR A PROSTHETIC DEVICECROSS REFERENCE TO RELATED APPLICATION

[0001] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 705,692, filed October 10, 2024, which is incorporated by reference herein.FIELD

[0002] The present disclosure relates to apparatus and methods for delivering, expanding, and implanting implantable, radially expandable prosthetic devices, such as prosthetic heart valves, stents, or the like.BACKGROUND

[0003] The human heart can suffer from various valvular diseases. These valvular diseases can result in significant malfunctioning of the heart and ultimately require repair of the native valve or replacement of the native valve with an artificial valve. There are a number of known repair devices (for example, stents) and artificial valves, as well as a number of known methods of implanting these devices and valves in humans. Percutaneous and minimally-invasive surgical approaches are used in various procedures to deliver prosthetic medical devices to locations inside the body that are not readily accessible by surgery or where access without surgery is desirable. In one specific example, a prosthetic heart valve can be mounted in a crimped state on the distal end of a delivery apparatus and advanced through the subject’s vasculature (for example, through a femoral artery and the aorta) until the prosthetic heart valve reaches the implantation site in the heart. The prosthetic heart valve is then expanded to its functional size, for example, by inflating a balloon on which the prosthetic valve is mounted, actuating a mechanical actuator that applies an expansion force to the prosthetic heart valve, or by deploying the prosthetic heart valve from a sheath of the delivery apparatus so that the prosthetic heart valve can self-expand to its functional size.SUMMARY

[0004] Described herein are prosthetic heart valves, delivery apparatus, and methods for implanting prosthetic heart valves. The disclosed prosthetic heart valves, delivery apparatus, and methods can advantageously, for example, provide for manipulation of a radius of curvature of a shaft of a delivery apparatus independent of an axial displacement of the shaft relative to other components of the delivery apparatus and / or relative to a prosthetic device. As such, the devices and methods disclosed herein can, among other things, overcome one or more of the deficiencies of typical prosthetic heart valves and their delivery apparatus.THVDL-1380IW001

[0005] A delivery apparatus for a prosthetic implant can comprise a handle and one or more shafts coupled to the handle.

[0006] In some examples, a delivery apparatus can comprise a shaft displacement mechanism configured to axially displace a shaft, and a shaft adjustment mechanism configured to adjust a curvature of the shaft independent of an axial displacement of the shaft.

[0007] In some examples, a delivery apparatus can comprise a shaft adjustment mechanism comprising a flex plate and a flex nut, wherein translation of the flex nut in a proximal direction drives translation of the flex plate in the proximal direction from a first axial position to a second axial position, wherein translation of the flex nut in a distal direction allows the flex plate to remain in the second axial position or return to the first axial position.

[0008] In some examples, a delivery apparatus for a prosthetic implant comprises a handle body; a shaft extending distally from the handle body, the shaft having a distal end and a proximal end; a shaft displacement mechanism coupled to the handle body, the shaft displacement mechanism comprising a carriage configured to translate axially relative to the handle body, wherein the proximal end of the shaft is coupled to the carriage; a shaft adjustment mechanism coupled to the handle body, the adjustment mechanism configured to adjust a curvature of the shaft, the shaft adjustment mechanism comprising a flex element and a pull wire, wherein the flex element is configured to translate axially relative to the carriage, wherein the pull wire has a distal end and a proximal end, wherein the distal end of the pull wire is coupled to the distal end of the shaft, wherein a proximal end of the pull wire is coupled to the flex element; a first knob operatively coupled to the shaft displacement mechanism and rotatable relative to the handle body, wherein rotating the first knob relative to the handle body simultaneously axially displaces the shaft and the pull wire relative to the handle body; and a second knob operatively coupled to the shaft adjustment mechanism and rotatable relative to the handle body, wherein the second knob is spaced apart from the first knob in the axial direction, wherein rotating the second knob relative to the handle body adjusts the curvature of the shaft independent of an axial displacement of the shaft.

[0009] In some examples, a delivery apparatus for a prosthetic implant comprises a handle body; a shaft extending distally from the handle body, the shaft having a distal end and a proximal end; a shaft displacement mechanism coupled to the handle body, the shaft displacement mechanism comprising a carriage configured to translate axially relative to the handle body, wherein the proximal end of the shaft is coupled to the carriage; a shaft adjustment mechanism coupled to the handle body, the adjustment mechanism configured to adjust a curvature of the shaft, the shaft adjustment mechanism comprising a flex nut, a flexTHVDL-13801W001 plate, and a pull wire having a distal end and a proximal end, wherein the flex nut and the flex plate are configured to translate axially relative to the carriage, wherein the distal end of the pull wire is coupled to the distal end of the shaft, wherein the proximal end of the pull wire is coupled to the flex plate, wherein translation of the flex nut in a proximal direction drives translation of the flex plate in the proximal direction from a first axial position to a second axial position, wherein translation of the flex nut in a distal direction allows the flex plate to remain in the second axial position or return to the first axial position; a first knob operatively coupled to the shaft displacement mechanism and rotatable relative to the handle body, wherein rotating the first knob relative to the handle body simultaneously axially displaces the shaft and the pull wire relative to the handle body; and a second knob operatively coupled to the shaft adjustment mechanism and rotatable relative to the handle body, wherein rotating the second knob relative to the handle body adjusts the curvature of the shaft independent of an axial displacement of the shaft.

[0010] In some examples, a delivery apparatus for a prosthetic implant comprises a handle body; a shaft extending distally from the handle body, the shaft having a lumen, a distal end and a proximal end; a shaft displacement mechanism coupled to the handle body, the shaft displacement mechanism comprising a carriage, wherein the proximal end of the shaft is coupled to the carriage; a shaft adjustment mechanism coupled to the handle body, the adjustment mechanism configured to adjust a curvature of the shaft, the shaft adjustment mechanism comprising a flex element configured to translate axially relative to the carriage and a pull wire having a distal end and a proximal end, wherein the distal end of the pull wire is coupled to the distal end of the shaft, wherein a proximal end of the pull wire is coupled to the flex element; a flush rod extending through the carriage, wherein the carriage is configured to translate axially relative to the flush rod between a first axial position relative to the flush rod and a second axial position relative to the flush rod, the flush rod including a flush lumen extending along a length of the flush rod and an opening in fluid communication with the flush lumen, wherein the opening is in fluid communication with the lumen of the shaft when the carriage is in the first axial position and the second axial position; a first knob operatively coupled to the shaft displacement mechanism and rotatable relative to the handle body, wherein rotating the first knob relative to the handle body simultaneously axially displaces the shaft and the pull wire relative to the handle body; and a second knob operatively coupled to the shaft adjustment mechanism and rotatable relative to the handle body, wherein rotating the second knob relative to the handle body adjusts the curvature of the shaft independent of an axial displacement of the shaft.THVDL-13801W001

[0011] In some examples, a delivery apparatus for a prosthetic implant comprises: a handle body; a shaft extending distally from the handle body, the shaft having a distal end portion and a proximal end portion; a shaft displacement mechanism coupled to the handle body, the shaft displacement mechanism comprising a slider configured to translate axially relative to the handle body, wherein the proximal end portion of the shaft is coupled to the slider; a shaft adjustment mechanism coupled to the handle body, the adjustment mechanism configured to adjust a curvature of the shaft, the shaft adjustment mechanism comprising a flex element and a pull wire, wherein the flex element is configured to translate axially relative to the slider, wherein the pull wire has a distal end portion and a proximal end portion, wherein the distal end portion of the pull wire is coupled to the distal end portion of the shaft, wherein a proximal end portion of the pull wire is coupled to the flex element; a first actuating mechanism operatively coupled to the shaft displacement mechanism and configured to, upon actuation, simultaneously axially displace the slider and the flex element in a first direction relative to the handle body; and a second actuating mechanism operatively coupled to the shaft adjustment mechanism and configured to, upon actuation, adjust an axial position of the flex element relative to the slider.

[0012] In some examples, a delivery apparatus comprises a third actuating mechanism, wherein the third actuating mechanism is operatively coupled to the shaft displacement mechanism and configured to, upon actuation, axially displace the slider in a second direction relative to the handle body, separate from the flex element.

[0013] In some examples, a delivery apparatus comprises a third actuating mechanism, wherein the third actuating mechanism is operatively coupled to the shaft displacement mechanism and configured to, upon actuation, axially displace the slider and the flex element in a second direction relative to the handle body.

[0014] In some examples, the first, second, and third actuating mechanisms are separate actuating mechanisms.

[0015] In some examples, a pull wire of a delivery apparatus is biased towards an unflexed state.

[0016] In some examples, a delivery apparatus comprises one or more of the components recited in Examples 1-25, and 31-35 below.

[0017] In some examples, a method of implanting a prosthetic device at a target implantation location within a subject comprises advancing a delivery shaft of a delivery apparatus through the subject’s vasculature to position the prosthetic device at a target implantation location, wherein the prosthetic device is at least partially received within a distal end portionTHVDL-13801W001 of the delivery shaft, and retracting the distal end portion of the delivery shaft proximally relative to the prosthetic device. In some examples, the advancing the delivery shaft through the subject’s vasculature comprises operating a shaft adjustment mechanism to adjust a curvature of the delivery shaft. In some examples, the retracting the distal end portion of the delivery shaft comprises operating a shaft displacement mechanism to move the delivery shaft relative to the prosthetic device without altering the curvature of the delivery shaft.

[0018] In some examples, a method comprises one or more of the steps recited in Examples 26-30 below.

[0019] The various innovations of this disclosure can be used in combination or separately. This summary is provided to introduce a selection of concepts in a simplified form that are further described below in the detailed description. This summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter. The foregoing and other objects, features, and advantages of the disclosure will become more apparent from the following detailed description, claims, and accompanying figures.BRIEF DESCRIPTION OF THE DRAWINGS

[0020] FIG. 1 A is a perspective view of one example of a prosthetic valve including a frame and a plurality of leaflets attached to the frame.

[0021] FIG. IB is a perspective view of the prosthetic valve of FIG. 1 A with an outer skirt disposed around the frame.

[0022] FIG. 2 A is a perspective view of a frame for the prosthetic valve of FIG. 1 A.

[0023] FIG. 2B is a front portion of the frame shown in FIG. 2A.

[0024] FIG. 3 is a side elevation view of a delivery apparatus for a prosthetic device, such as a prosthetic valve, according to one example.

[0025] FIG. 4 is a perspective view of a portion of an actuator of the prosthetic device of FIGS. 1-2 and an actuator assembly of a delivery apparatus, according to one example.

[0026] FIG. 5 is a perspective view of the actuator and actuator assembly of FIG. 4 with the actuator assembly physically coupled to the actuator.

[0027] FIG. 6 is a side elevation view of a delivery apparatus for a prosthetic device, such as a prosthetic valve, according to one example.

[0028] FIG. 7 is a cross-sectional view of the delivery apparatus of FIG. 6.

[0029] FIG. 8 is a perspective view of the delivery apparatus of FIG. 6, with an outer housing removed for purposes of illustration.THVDL-1380IW001

[0030] FIG. 9 is a detailed perspective view of gear assemblies of the delivery apparatus of FIG. 6.

[0031] FIG. 10 is a perspective, cross-sectional view of the delivery apparatus of FIG. 6, taken along section A-A.

[0032] FIG. 11 A is a cross-sectional view of the delivery apparatus of FIG. 6 with a displacement mechanism in a first position.

[0033] FIG. 11B is a cross-sectional view of the delivery apparatus of FIG. 6 with the displacement mechanism in a second position.

[0034] FIG. 11C is a cross-sectional view of the delivery apparatus of FIG. 6 with the displacement mechanism in a third position.

[0035] FIG. 12 is a perspective, cross-sectional view of an adjustment mechanism of the delivery apparatus of FIG. 6.

[0036] FIG. 13 is a perspective view of a flex element and pull wire of the delivery apparatus of FIG. 6.

[0037] FIG. 14 is a perspective view of a gear assembly of the delivery apparatus of FIG. 6.

[0038] FIG. 15 is a partial, cross-sectional view of the adjustment mechanism of the delivery apparatus of FIG. 6.

[0039] FIG. 16A is a cross-sectional view of the adjustment mechanism of the delivery apparatus of FIG. 6 with a flex nut and the flex element in a first position.

[0040] FIG. 16B is a cross-sectional view of the adjustment mechanism of the delivery apparatus of FIG. 6 with the flex nut and the flex element in a second position.

[0041] FIG. 16C is a cross-sectional view of the adjustment mechanism of the delivery apparatus of FIG. 6 with the flex nut in the first position and the flex element in the second position.

[0042] FIG. 17 is a cross-sectional view of a distal end portion of a handle of the delivery apparatus of FIG. 6.

[0043] FIG. 18A is a cross-sectional view of the delivery apparatus of FIG. 6 with a carriage in a first position.

[0044] FIG. 18B is a cross-sectional view of the delivery apparatus of FIG. 6 with the carriage in a second position.

[0045] FIG. 19 is a cross-sectional view of the delivery apparatus of FIG. 6, taken along section B-B.DETAILED DESCRIPTIONGeneral ConsiderationsTHVDL-13801W001

[0046] For purposes of this description, certain aspects, advantages, and novel features of examples of this disclosure are described herein. The disclosed methods, apparatus, and systems should not be construed as being limiting in any way. Instead, the present disclosure is directed toward all novel and nonobvious features and aspects of the various disclosed examples, alone and in various combinations and sub-combinations with one another. The methods, apparatus, 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.

[0047] Although the operations of some of the disclosed examples are described in a particular, sequential order for convenient presentation, it should be understood that this manner of description encompasses rearrangement, unless a particular ordering is required by specific language set forth below. For example, operations described sequentially may in some cases be rearranged or performed concurrently. Moreover, for the sake of simplicity, the attached figures may not show the various ways in which the disclosed methods can be used in conjunction with other methods. Additionally, the description sometimes uses terms like “provide” or “achieve” to describe the disclosed methods. These terms are high-level abstractions of the actual operations that are performed. The actual operations that correspond to these terms may vary depending on the particular implementation and are readily discernible by one of ordinary skill in the art.

[0048] Reference throughout this specification to “an implementation” means that a particular feature, structure, or characteristic described in connection with the implementation is included in at least one implementation. Thus, appearances of the phrases “in an implementation” in various places throughout this specification are not necessarily all referring to the same implementation or a single exclusive implementation. Furthermore, the particular features, structures, or characteristics described herein may be combined in any suitable manner in one or more implementations.

[0049] Groupings of alternative elements or implementations of the disclosure herein are not to be construed as limitations. Each group member can be referred to and claimed individually or in any combination with other members of the group or other elements found herein. One or more members of a group can 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 herein deemed to contain the group as modified thus fulfilling the written description of all groups used in the appended claims.THVDL-13801W001

[0050] As used in this application and in the claims, the singular forms “a,” “an,” and “the” include the plural forms unless the context clearly dictates otherwise. Additionally, the term “includes” means “comprises.” The terms “comprises” and “comprising” should be interpreted as referring to elements, components, or steps in a non-exclusive manner, indicating that the referenced elements, components, or steps may be present, or utilized, or combined with other elements, components, or steps not expressly referenced. Further, the term “coupled” generally means physically, mechanically, chemically, magnetically, and / or electrically coupled or linked and does not exclude the presence of intermediate elements between the coupled or associated items absent specific contrary language. It is further noted that the claims can be drafted to exclude any optional element. As such, this statement is intended to serve as antecedent basis for use of such exclusive terminology as “solely,” “only” and the like in connection with the recitation of claim elements, or use of a “negative” limitation.

[0051] As used herein, the term “proximal” refers to a position, direction, or portion of a device that is closer to the user and further away from the implantation site. As used herein, the term “distal” refers to a position, direction, or portion of a device that is further away from the user and closer to the implantation site. Thus, for example, proximal motion of a device is motion of the device away from the implantation site and toward the user (for example, out of the subject body), while distal motion of the device is motion of the device away from the user and toward the implantation site (for example, into the subject’s body). The terms “longitudinal” and “axial” refer to an axis extending in the proximal and distal directions, unless otherwise expressly defined.

[0052] As used herein, “e.g.” means “for example,” and “i.e.” means “that is.”

[0053] The illustrations may include exaggerated dimensions and graphical representation to better illustrate the referenced items shown, and are not considered limiting unless expressly stated as such.Examples of the Disclosed Technology

[0054] FIGS. 1A-2B show a prosthetic valve 100, according to one example. The prosthetic valves disclosed herein are adapted to be implanted in the native aortic annulus, although in some examples they can be adapted to be implanted in the other native annuluses of the heart (the pulmonary, mitral, and tricuspid valves). The disclosed prosthetic valves also can be implanted within vessels communicating with the heart, including a pulmonary artery (for replacing the function of a diseased pulmonary valve, or the superior vena cava or the inferior vena cava (for replacing the function of a diseased tricuspid valve) or various other veins,THVDL-13801W001 arteries, and vessels of a subject. The disclosed prosthetic valves also can be implanted within a previously implanted prosthetic valve (which can be a prosthetic surgical valve or a prosthetic transcatheter heart valve) in a valve-in-valve procedure. As used herein, the term “subject” can refer to any of a variety of subjects, such as a living subject (e.g., a human subject or a non-human subject) or a simulation. In various examples, the subject may be a human patient.

[0055] In some examples, the disclosed prosthetic valves can be implanted within a docking or anchoring device that is implanted within a native heart valve or a vessel. For example, in one example, the disclosed prosthetic valves can be implanted within a docking device implanted within the pulmonary artery for replacing the function of a diseased pulmonary valve, such as disclosed in U.S. Publication No. 2017 / 0231756, which is incorporated by reference herein. This and all other extrinsic materials discussed herein, including publications, patent applications, and patents, are incorporated by reference in their entirety. In some examples, the disclosed prosthetic valves can be implanted within a docking device implanted within or at the native mitral valve, such as disclosed in PCT Publication No. W02020 / 247907, which is incorporated herein by reference. In some examples, the disclosed prosthetic valves can be implanted within a docking device implanted within the superior or inferior vena cava for replacing the function of a diseased tricuspid valve, such as disclosed in U.S. Publication No. 2019 / 0000615, which is incorporated herein by reference.

[0056] FIGS. 1A-2B illustrate an example of a prosthetic device 100 (which also may be referred to herein as “prosthetic device 100,” “prosthetic valve 100,” or “prosthetic heart valve 100”) having a frame 102. FIGS. 2A-2B show the frame 102 by itself, while FIGS. 1 A- 1B show the frame 102 with a valvular structure 150 (which can comprise leaflets 158, as described further below) mounted within and to the annular frame 102. FIG. IB additionally shows an optional skirt assembly comprising an outer skirt 103. While only one side of the frame 102 is depicted in FIG. 2B, it should be appreciated that the frame 102 forms an annular structure having an opposite side that is substantially identical to the portion shown in FIG. 2B, as shown in FIGS. 1A-2A.

[0057] As shown in FIGS. 1A and IB, the valvular structure 150 is coupled to and supported inside the frame 102. The valvular structure 150 is configured to regulate the flow of blood through the prosthetic valve 100, from an inflow end portion 134 to an outflow end portion 136. The valvular structure 150 can include, for example, a leaflet assembly comprising one or more leaflets 158 made of flexible material. The leaflets 158 can be made from in whole or part, biological material, bio-compatible synthetic materials, or other such materials. SuitableTHVDL-13801W001 biological material can include, for example, bovine pericardium (or pericardium from other sources). The leaflets 158 can be secured to one another at their adjacent sides to form commissures 152, each of which can be secured to a respective commissure support structure 144 (also referred to herein as “commissure supports”) and / or to other portions of the frame 102, as described in greater detail below.

[0058] In the example depicted in FIGS. 1A and IB, the valvular structure 150 includes three leaflets 158, which can be arranged to collapse in a tricuspid arrangement. Each leaflet 158 can have an inflow edge portion 160 (which can also be referred to as a cusp edge portion) (FIG. 1 A). The inflow edge portions 160 of the leaflets 158 can define an undulating, curved scallop edge that generally follows or tracks portions of struts 112 of frame 102 in a circumferential direction when the frame 102 is in the radially expanded configuration. The inflow edge portions 160 of the leaflets 158 can be referred to as a “scallop line.”

[0059] The prosthetic valve 100 may include one or more skirts mounted around the frame 102. For example, as shown in FIG. IB, the prosthetic valve 100 may include an outer skirt 103 mounted around an outer surface of the frame 102. The outer skirt 103 can function as a sealing member for the prosthetic valve 100 by sealing against the tissue of the native valve annulus and helping to reduce paravalvular leakage past the prosthetic valve 100. In some cases, an inner skirt (not shown) may be mounted around an inner surface of the frame 102. The inner skirt can function as a sealing member to prevent or decrease perivalvular leakage, to anchor the leaflets 158 to the frame 102, and / or to protect the leaflets 158 against damage caused by contact with the frame 102 during crimping and during working cycles of the prosthetic valve 100. In some examples, the inflow edge portions 160 of the leaflets 158 can be sutured to the inner skirt generally along the scallop line. The inner skirt can in turn be sutured to adjacent struts 112 of the frame 102. In some examples, as shown in FIG. 1A, the leaflets 158 can be sutured directly to the frame 102 or to a reinforcing member 125 (also referred to as a reinforcing skirt or connecting skirt) in the form of a strip of material (for example, a fabric strip) which is then sutured to the frame 102, along the scallop line via stitches (for example, whip stitches) 133.

[0060] The skirt can be wholly or partly formed of any suitable biological material, synthetic material (for example, any of various polymers), or combinations thereof. In some examples, the skirt can comprise a fabric having interlaced yams or fibers, such as in the form of a woven, braided, or knitted fabric. In some examples, the fabric can have a plush nap or pile. Example fabrics having a phis nap or pile include velour, velvet, velveteen, corduroy, terrycloth, fleece, etc, In some examples, the skirt can comprise a fabric without interlacedTHVDL-13801W001 yams or fibers or randomly interlaced yams or fibers, such as felt or an electrospun fabric. Example materials that can be used for forming such fabrics (with or without interlaced yams or fibers) include, without limitation, polyethylene (PET), ultra-high molecular weight polyethylene (UHMWPE), polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (ePTFE), polyamide etc. In some examples, the skirt can comprise a non-textile or non-fabric material, such as a film made from any of a variety of polymeric materials, such as PTFE, PET. polypropylene, polyamide, polyetheretherketone (PEEK), polyurethane (such as thermoplastic polyurethane (TPU)), etc In some examples, the skirt can comprise a sponge material or foam, such as polyurethane foam. In some examples, the skirt can comprise natural tissue, such as pericardium (for example, bovine pericardium, porcine pericardium, equine pericardium, or pericardium from other sources).

[0061] The inner and outer skirts and the connecting skirt 125 can comprise and / or can be formed from any of various suitable biocompatible materials, including any of various synthetic materials, including fabrics (for example, polyethylene terephthalate fabric) or natural tissue (for example, pericardial tissue). Further details regarding the use of skirts or sealing members in prosthetic valve can be found, for example, in U.S. Patent Publication No. 2020 / 0352711, which is incorporated herein by reference.

[0062] Further details regarding the assembly of the leaflet assembly and the assembly of the leaflets and the skirts to the frame can be found, for example, in International Patent Application No. PCT / US2022 / 032983, filed June 10, 2022, and U.S. Provisional Application 63 / 224,534, filed July 22, 2021, which are incorporated herein by reference. Further details of the construction and function of the frame 102 can be found in International Patent Application No. PCT / US2021 / 052745, filed September 30, 2021, which is incorporated herein by reference.

[0063] The frame 102, which is shown alone and in greater detail in FIGS. 2A and 2B, comprises and inflow end 109, an outflow end 108, and a plurality of axially extending posts 104. The axial direction of the frame 102 is indicated by a longitudinal axis 105, which extends from the inflow end 109 to the outflow end 108 (FIGS. 2A and 2B). Some of the posts 104 can be arranged in pairs of axially aligned first and second struts or posts 122, 124. An actuator 126 (such as the illustrated threaded rod or bolt) can extend through one or more pairs of posts 122, 124 to form an integral expansion and locking mechanism or actuator mechanism 106 configured to radially expand and compress the frame 102, as further described below. One or more of posts 104 can be configured as support posts 107.THVDL-13801W001

[0064] The actuator mechanisms 106 (which can be used to radially expand and / or radially compress the prosthetic valve 100) can be integrated into the frame 102 of the prosthetic valve 100, thereby reducing the crimp profile and / or bulk of the prosthetic valve 100. Integrating the actuator mechanisms 106 (which can also be referred to herein as “expansion and locking mechanisms”) into the frame 102 can also simplify the design of the prosthetic valve 100, making the prosthetic valve 100 less costly and / or easier to manufacture. In the illustrated example, an actuator 126 extends through each pair of axially aligned posts 122, 124. In some examples, one or more of the pairs of posts 122, 124 can be without a corresponding actuator.

[0065] The posts 104 can be coupled together by a plurality of circumferentially extending link members or struts 112. Each strut 112 extends circumferentially between adjacent posts 104 to connect all of the axially extending posts 104. As one example, the prosthetic valve 100 can include equal numbers of support posts 107 and pairs of actuator posts 122, 124 and the pairs of posts 122, 124 and the support posts 107 can be arranged in an alternating order such that each strut 112 is positioned between one of the pairs of posts 122, 124 and one of the support posts 107 (that is, each strut 112 can be coupled on one end to one of the posts 122, 124 and can be coupled on the other end to one of the support posts 107). However, the prosthetic valve 100 can include different numbers of support posts 107 and pairs of posts 122, 124 and / or the pairs of posts 122, 124 and the support posts 107 can be arranged in a non- alternating order, in some examples.

[0066] As illustrated in FIG. 2B, the struts 112 can include a first row of struts 113 at or near the inflow end 109 of the prosthetic valve 100, a second row of struts 114 at or near the outflow end 108 of the prosthetic valve 100, and third and fourth rows of struts 115, 116, respectively, positioned axially between the first and second rows of struts 113, 114. The struts 112 can form and / or define a plurality of cells (that is, openings) in the frame 102. For example, the struts 113, 114, 115, and 116 can at least partially form and / or define a plurality of first cells 117 and a plurality of second cells 118 that extend circumferentially around the frame 102. Specifically, each first cell 117 can comprise and / or be formed by two struts 113a, 113b of the first row of struts 113, two struts 114a, 114b of the second row of struts 114, and two of the support posts 107. Each second cell 118 can comprise and / or be formed by two struts 115a, 115b of the third row of struts 115 and two struts 116a, 116b of the fourth row of struts 116. As illustrated in FIGS. 2A and 2B, each second cell 118 can be disposed within one of the first cells 117 (that is, the struts 115a-116b forming the second cells 118 areTHVDL-13801W001 disposed between the struts forming the first cells 117 (that is, the struts 113a, 113b and the struts 114a, 114b), closer to an axial midline of the frame 102 than the struts 113a-l 14b).

[0067] As illustrated in FIGS. 2A and 2B, the struts 112 of frame 102 can comprise a curved shape. Each first cell 117 can have an axially-extending hexagonal shape including first and second apices 119 (for example, an inflow apex 119a and an outflow apex 119b). In examples where the delivery apparatus is releasably connected to the outflow apices 119b (as described below), each inflow apex 119a can be referred to as a “distal apex” and each outflow apex 1 19b can be referred to as a “proximal apex”. Each second cell 1 18 can have a diamond shape including first and second apices 120 (for example, distal apex 120a and proximal apex 120b). In some examples, the frame 102 comprises six first cells 117 extending circumferentially in a row, six second cells 118 extending circumferentially in a row within the six first cells 117, and twelve posts 104. However, in some examples, the frame 102 can comprise a greater or fewer number of first cells 117 and a correspondingly greater or fewer number of second cells 118 and posts 104.

[0068] As noted above, some of the posts 104 can be arranged in pairs of first and second posts 122, 124. The posts 122, 124 are aligned with each other along the length of the frame 102 and are axially separated from one another by a gap G (FIG. 2B) (those with actuators 126 can be referred to as actuator posts or actuator struts). Each first post 122 (that is, the lower post shown in FIGS. 2A and 2B) can extend axially from the inflow end 109 of the prosthetic valve 100 toward the second post 124, and the second post 124 (that is, the upper post shown in FIGS. 2A and 2B) can extend axially from the outflow end 108 of the prosthetic valve 100 toward the first post 122. For example, each first post 122 can be connected to and extend from an inflow apex 119a and each second post 124 can be connected to and extend from an outflow apex 119b. Each first post 122 and the second post 124 can include an inner bore configured to receive a portion of an actuator member, such as in the form of a substantially straight threaded rod 126 (or bolt) as shown in the illustrated example. The threaded rod 126 also may be referred to herein as actuator 126, actuator member 126, and / or screw actuator 126. In examples where the delivery apparatus can be releasably connected to the outflow end 108 of the frame 102, the first posts 122 can be referred to as distal posts or distal axial struts and the second posts 124 can be referred to as proximal posts or proximal axial struts.

[0069] Each threaded rod 126 extends axially through a corresponding first post 122 and second post 124. Each threaded rod 126 also extends through a bore of a nut 127 captured within a slot or window formed in an end portion 128 of the first post 122. The threaded rodTHVDL-13801W001126 has external threads that engage internal threads of the bore of the nut 127. The inner bore of the second post 124 (through which the threaded rod 126 extends) can have a smooth and / or non-threaded inner surface to allow the threaded rod 126 to slide freely within the bore. Rotation of the threaded rod 126 relative to the nut 127 produces radial expansion and compression of the frame 102, as further described below.

[0070] In some examples, the threaded rod 126 can extend past the nut 127 toward the inflow end 109 of the frame 102 into the inner bore of the first post 122. The nut 127 can be held in a fixed position relative to the first post 122 such that the nut 127 does not rotate relative to the first post 122. In this way, whenever the threaded rod 126 is rotated (for example, by a physician) the threaded rod 126 can rotate relative to both the nut 127 and the first post 122. The engagement of the external threads of the threaded rod 126 and the internal threads of the nut 127 prevent the rod 126 from moving axially relative to the nut 127 and the first post 122 unless the threaded rod 126 is rotated relative to the nut 127. Thus, the threaded rod 126 can be retained or held by the nut 127 and can only be moved relative to the nut 127 and / or the first post 122 by rotating the threaded rod 126 relative to the nut 127 and / or the first post 122. In some examples, in lieu of using the nut 127, at least a portion of the inner bore of the first post 122 can be threaded. For example, the bore along the end portion 128 of the first post 122 can comprise inner threads that engage the external threaded rod 126 such that rotation of the threaded rod causes the threaded rod 126 to move axially relative to the first post 122.

[0071] When a threaded rod 126 extends through and / or is otherwise coupled to a pair of axially aligned posts 122, 124, the pair of axially aligned posts 122, 124 and the threaded rod 126 can serve as one of the expansion and locking mechanisms 106. In some examples, a threaded rod 126 can extend through each pair of axially aligned posts 122, 124 so that all of the posts 122, 124 (with their corresponding rods 126) serve as expansion and locking mechanisms 106. As just one example, the prosthetic valve 100 can include six pairs of posts 122, 124, and each of the six pairs of posts 122, 124 with their corresponding rods 126 can be configured as one of the expansion and locking mechanisms 106 for a total of six expansion and locking mechanisms 106. In some examples, not all pairs of posts 122, 124 need be expansion and locking mechanisms (that is, actuators). If a pair of posts 122, 124 is not used as an expansion and locking mechanism, a threaded rod 126 need not extend through the posts 122, 124 of that pair.

[0072] The threaded rod 126 can be rotated relative to the nut 127, the first post 122, and the second post 124 to axially foreshorten and / or axially elongate the frame 102, thereby radially expanding and / or radially compressing, respectively, the frame 102 (and therefore theTHVDL-1380IW001 prosthetic valve 100). Specifically, when the threaded rod 126 is rotated relative to the nut 127, the first post 122, and the second post 124, the first and second posts 122, 124 can move axially relative to one another, thereby widening or narrowing the gap G (FIG. 2B) separating the posts 122, 124, and thereby radially compressing or radially expanding the prosthetic valve 100, respectively. Thus, the gap G (FIG. 2B) between the first and second posts 122, 124 narrows as the frame 102 is radially expanded and widens as the frame 102 is radially compressed.

[0073] The threaded rod 126 can extend proximally past the proximal end of the second post 124 and can include a head portion 131 at its proximal end that can serve at least two functions. First, the head portion 131 can removably or releasably couple the threaded rod 126 to a respective actuator assembly of a delivery apparatus that can be used to radially expand and / or radially compress the prosthetic valve 100 (for example, the delivery apparatus 200 of FIG. 3, as described below). Second, the head portion 131 can prevent the second post 124 from moving proximally relative to the threaded rod 126 and can apply a distally directed force to the second post 124, such as when radially expanding the prosthetic valve 100. Specifically, the head portion 131 can have a width greater than a diameter of the inner bore of the second post 124 such that the head portion 131 is prevented from moving into the inner bore of the second post 124. Thus, as the threaded rod 126 is threaded farther into the nut 127, the head portion 131 of the threaded rod 126 draws closer to the nut 127 and the first post 122, thereby drawing the second post 124 towards the first post 122, and thereby axially foreshortening and radially expanding the prosthetic valve 100.

[0074] The threaded rod 126 also can include a stopper 132 (for example, in the form of a nut, washer or flange) disposed thereon. The stopper 132 can be disposed on the threaded rod 126 such that it sits within the gap G. Further, the stopper 132 can be integrally formed on or fixedly coupled to the threaded rod 126 such that it does not move relative to the threaded rod 126. Thus, the stopper 132 can remain in a fixed axial position on the threaded rod 126 such that it moves in lockstep with the threaded rod 126.

[0075] Rotation of the threaded rod 126 in a first direction (for example, clockwise) can cause corresponding axial movement of the first and second posts 122, 124 toward one another, thereby decreasing the gap G and radially expanding the frame 102, while rotation of the threaded rod 126 in an opposite second direction causes corresponding axial movement of the first and second posts 122, 124 away from one another, thereby increasing the gap G and radially compressing the frame. When the threaded rod 126 is rotated in the first direction, the head portion 131 of the rod 126 bears against an adjacent surface of the frame (forTHVDL-13801W001 example, an outflow apex 119b), while the nut 127 and the first post 122 travel proximally along the threaded rod 126 toward the second post 124, thereby radially expanding the frame. As the frame 102 moves from a compressed configuration to an expanded configuration, the gap G between the first and second posts 122, 124 can narrow.

[0076] When the threaded rod 126 is rotated in the second direction, the threaded rod 126 and the stopper 132 move toward the outflow end 108 of the frame until the stopper 132 abuts the inflow end 170 of the second post 124 (as shown in FIGS. 2A and 2B). Upon further rotation of the rod 126 in the second direction, the stopper 132 can apply a proximally directed force to the second post 124 to radially compress the frame 102. Specifically, during crimping / radial compression of the prosthetic valve 100, the threaded rod 126 can be rotated in the second direction (for example, counterclockwise) causing the stopper 132 to push against (that is, provide a proximally directed force to) the inflow end 170 of the second post 124, thereby causing the second post 124 to move away from the first post 122, and thereby axially elongating and radially compressing the prosthetic valve 100.

[0077] Thus, each of the second posts 124 can slide axially relative to a corresponding one of the first posts 122 but can be axially retained and / or restrained between the head portion 131 of a threaded rod 126 and a stopper 132. That is, each second post 124 can be restrained at its proximal end by the head portion 131 of the threaded rod 126 and at its distal end by the stopper 132. In this way, the head portion 131 can apply a distally directed force to the second post 124 to radially expand the prosthetic valve 100 while the stopper 132 can apply a proximally directed force to the second post 124 to radially compress the prosthetic valve 100. As explained above, radially expanding the prosthetic valve 100 axially foreshortens the prosthetic valve 100, causing an inflow end portion 134 and outflow end portion 136 of the prosthetic valve 100 (FIGS. 1A and IB) to move towards one another axially, while radially compressing the prosthetic valve 100 axially elongates the prosthetic valve 100, causing the inflow and outflow end portions 134, 136 to move away from one another axially.

[0078] In some examples, the threaded rod 126 can be fixed against axial movement relative to the second post 124 (and the stopper 132 can be omitted) such that rotation of the threaded rod 126 in the first direction produces proximal movement of the nut 127 and radial expansion of the frame 102 and rotation of the threaded rod 126 in the second direction produces distal movement of the nut 127 and radial compression of the frame 102.

[0079] As also introduced above, some of the posts 104 can be configured as support posts 107. As shown in FIGS. 2A and 2B, the support posts 107 can extend axially between the inflow and outflow ends 109, 108 of the frame 102 and each can have an inflow end portionTHVDL-13801W001138 and an outflow end portion 139. The outflow end portion 139 of one or more support posts 107 can include a commissure support structure or member 144. The commissure support structure 144 can comprise strut portions defining a commissure opening 146 therein.

[0080] The commissure opening 146 (which can also be referred to herein as a “commissure window 146”) can extend radially through a thickness of the support post 107 and can be configured to accept a portion of a valvular structure 150 (for example, a commissure 152) to couple the valvular structure 150 to the frame 102. For example, each commissure 152 can be mounted to a respective commissure support structure 144, such as by inserting a pair of commissure tabs of adjacent leaflets 158 through the commissure opening 146 and suturing the commissure tabs to each other and / or the commissure support structure 144. In some examples, the commissure opening 146 can be fully enclosed by the support post 107 such that a portion of the valvular structure 150 can be slid radially through the commissure opening 146, from an interior to an exterior of the frame 102, during assembly. In the illustrated example, the commissure opening 146 has a substantially rectangular shape that is shaped and sized to receive commissure tabs of two adjacent leaflets therethrough. However, in some examples, the commissure opening can have any of various shapes (for example, square, oval, square-oval, triangular, L-shaped, T-shaped, C-shaped, etc.).

[0081] The commissure openings 146 are spaced apart about the circumference of frame 102 (or angularly spaced apart about frame 102). The spacing may or may not be even. In one example, the commissure openings 146 are axially offset from the outflow end 108 of the frame 102 by an offset distance d3 (indicated in FIG. 2A). As an example, the offset distance ds may be in a range from 2 mm to 6 mm. In general, the offset distance d3 should be selected such that when the leaflets are attached to the frame 102 via the commissure openings 146, the free edge portions (for example, outflow edge portions) of the leaflets 158 will not protrude from or past the outflow end 108 of the frame 102.

[0082] The frame 102 can comprise any number of support posts 107, any number of which can be configured as commissure support structures 144. For example, the frame 102 can comprise six support posts 107, three of which are configured as commissure support structures 144. However, in some examples, the frame 102 can comprise more or less than six support posts 107 and / or more or less than three commissure support structures 144.

[0083] The inflow end portion 138 of each support post 107 can comprise an extension 154 (show as a cantilevered strut in FIGS. 2A and 2B) that extends toward the inflow end 109 of the frame 102. Each extension 154 can comprise an aperture 156 extending radially through a thickness of the extension 154. In some examples, the extension 154 can extend such that anTHVDL-13801W001 inflow edge of the extension 154 aligns with or substantially aligns with the inflow end 109 of the frame 102. In use, the extension 154 can prevent or mitigate portions of an outer skirt from extending radially inwardly and thereby prevent or mitigate any obstruction of flow through the frame 102 caused by the outer skirt. The extensions 154 can further serve as supports to which portions of the inner and / or outer skirts and / or the leaflets and / or the connecting skirt 125 can be coupled. For example, sutures used to connect the inner and / or outer skirts and / or the leaflets and / or the connecting skirt 125 can be wrapped around the extensions 154 and / or can extend through apertures 156.

[0084] As an example, each extension 154 can have an aperture 156 (FIG. 2A) or other features to receive a suture or other attachment material for connecting an adjacent inflow edge portion 160 of a leaflet 158 (FIG. 1A), the outer skirt 103 (in FIG. IB), the connecting skirt 125, and / or an inner skirt. In some examples, the inflow edge portion 160 of each leaflet 158 can be connected to a corresponding extension via a suture 135 (FIG. 1 A).

[0085] In some examples, the outer skirt 103 can be mounted around the outer surface of frame 102 as shown in FIG. IB and the inflow edge of the outer skirt 103 (lower edge in FIG. IB) can be attached to the connecting skirt 125 and / or the inflow edge portions 160 of the leaflets 158 that have already been secured to frame 102 as well as to the extensions 154 of the frame by sutures 129. The outflow edge of the outer skirt 103 (the upper edge in FIG. IB) can be attached to selected struts with stitches 137. In implementations where the prosthetic valve includes an inner skirt, the inflow edge of the inner skirt can be secured to the inflow edge portions 160 before securing the cusp edge portions to the frame so that the inner skirt will be between the leaflets and the inner surface of the frame. After the inner skirt and leaflets are secured in place, then the outer skirt can be mounted around the frame as described above.

[0086] The frame 102 can be a unitary and / or fastener-free frame that can be constructed from a single piece of material (for example, Nitinol, stainless steel, or a cobalt-chromium alloy), such as in the form of a tube. The plurality of cells can be formed by removing portions (for example, via laser cutting) of the single piece of material. The threaded rods 126 can be separately formed and then be inserted through the bores in the second (proximal) posts 124 and threaded into the threaded nuts 127.

[0087] In some examples, the frame 102 can comprise and / or be formed from a plastically - expandable material, such as stainless steel or a cobalt-chromium alloy. When the frame is formed from a plastically-expandable material, the prosthetic valve 100 can be placed in a radially compressed state along the distal end portion of a delivery apparatus for insertionTHVDL-13801W001 into a subject’s body. When at the desired implantation site, the frame 102 (and therefore the prosthetic valve 100) can be radially expanded from the radially compressed state to a radially expanded state via actuation of actuation assemblies of the delivery apparatus (as further described below), which rotate the rods 126 to produce expansion of the frame 102. During delivery to the implantation site, the prosthetic valve 100 can be placed inside of a delivery capsule (sheath) to protect against the prosthetic valve contacting the subject’s vasculature, such as when the prosthetic valve is advanced through a femoral artery. The capsule can also retain the prosthetic valve in a compressed state having a slightly smaller diameter and crimp profile than may be otherwise possible without a capsule by preventing any recoil (expansion) of the frame once it is crimped onto the delivery apparatus.

[0088] Suitable plastically -expandable materials that can be used to form the frames disclosed herein (for example, the frame 102) include, metal alloys, polymers, or combinations thereof. Example metal alloys can comprise one or more of the following: nickel, cobalt, chromium, molybdenum, titanium, or other biocompatible metal. In some examples, the frame can comprise stainless steel. In some examples, the frame 102 can comprise cobalt-chromium. In some examples, the frame 102 can comprise nickel-cobalt- chromium. In some examples, the frame 102 comprises a nickel-cobalt-chromium- molybdenum alloy, such as MP35N™ (tradename of SPS Technologies), which is equivalent to UNS R30035 (covered by ASTM F562-02). MP35N™ / UNS R30035 comprises 35% nickel, 35% cobalt, 20% chromium, and 10% molybdenum, by weight.

[0089] In some examples, the frame 102 can comprise and / or be formed from a selfexpandable material (for example, Nitinol). When the frame 102 is formed from a selfexpandable material, the prosthetic valve can be radially compressed and placed inside the capsule of the delivery apparatus to maintain the prosthetic valve in the radially compressed state while it is being delivered to the implantation site. When at the desired implantation site, the prosthetic valve is deployed or released from the capsule. In some examples, the frame (and therefore the prosthetic valve) can partially self-expand from the radially compressed state to a partially radially expanded state. The frame 102 (and therefore the prosthetic valve 100) can be further radially expanded from the partially expanded state to a further radially expanded state via actuation of actuation assemblies of the delivery apparatus (as further described below), which rotate the rods 126 to produce expansion of the frame.

[0090] Described herein are examples of a steerable delivery apparatus (sometimes referred to as a steerable catheter) that can be used to navigate a subject’s vasculature to deliver an implantable, expandable medical device (e.g., a prosthetic heart valve), tools, agents, or otherTHVDL-13801W001 therapy to a location within the body of a subject. Examples of procedures in which the steerable catheters are useful include neurological, urological, gynecological, fertility (e.g., in vitro fertilization, artificial insemination), laparoscopic, arthroscopic, transesophageal, transvaginal, transvesical, transrectal, and procedures including access in any body duct or cavity. Particular examples include placing implants, including stents, grafts, embolic coils, and the like; positioning imaging devices and / or components thereof, including ultrasound transducers; and positioning energy sources, for example, for performing lithotripsy, RF sources, ultrasound emitters, electromagnetic sources, laser sources, thermal sources, and the like.

[0091] As introduced above, the threaded rods 126 can removably couple the prosthetic valve 100 to actuator assemblies of a delivery apparatus. Referring to FIG. 3, it illustrates an example of a delivery apparatus 200 for delivering the prosthetic valve 100 to a desired implantation location. The prosthetic valve 100 can be releasably coupled to the delivery apparatus 200. It should be understood that the delivery apparatus 200 and other delivery apparatuses disclosed herein can be used to implant prosthetic devices other than prosthetic valves, such as stents or grafts.

[0092] The delivery apparatus 200 in the illustrated example generally includes a handle 204, a first elongated shaft 206 (which comprises an outer shaft in the illustrated example) extending distally from the handle 204, at least one actuator assembly 208 extending distally through the first shaft 206, a second elongated shaft 209 (which comprises an inner shaft in the illustrated example) extending through the first shaft 206, and a nosecone 210 coupled to a distal end portion of the second shaft 209. The second shaft 209 and the nosecone 210 can define a guidewire lumen for advancing the delivery apparatus through a subject’s vasculature over a guidewire. The at least one actuator assembly 208 can be configured to radially expand and / or radially collapse the prosthetic valve 100 when actuated, such as by one or more knobs 211, 212, 214 included on the handle 204 of the delivery apparatus 200.

[0093] Though the illustrated example shows two actuator assemblies 208 for purposes of illustration, it should be understood that one actuator assembly 208 can be provided for each actuator (for example, actuator or threaded rod 126) on the prosthetic valve. For example, three actuator assemblies 208 can be provided for a prosthetic valve having three actuators. In some examples, a greater or fewer number of actuator assemblies 208 can be present.

[0094] In some examples, a distal end portion 216 of the shaft 206 can be sized to house the prosthetic valve in its radially compressed, delivery state during delivery of the prosthetic valve through the subject’s vasculature. In this manner, the distal end portion 216 functionsTHVDL-13801W001 as a delivery sheath or capsule for the prosthetic valve during delivery. The distal end portion 216 is also referred to herein as “delivery sheath 216” or “sheath 216.” It should be noted that the distal end portion of the shaft can also be used to house various other implantable devices (for example, stents, grafts, etc.).

[0095] The actuator assemblies 208 can be releasably coupled to the prosthetic valve 100. For example, in the illustrated example, each actuator assembly 208 can be coupled to a respective actuator (for example, threaded rod 126) of the prosthetic valve 100. Each actuator assembly 208 can comprise a support tube and an actuator member. When actuated, the actuator assembly can transmit pushing and / or pulling forces to portions of the prosthetic valve to radially expand and collapse the prosthetic valve as previously described. The actuator assemblies 208 can be at least partially disposed radially within, and extend axially through, one or more lumens of the first shaft 206. For example, the actuator assemblies 208 can extend through a central lumen of the shaft 206 or through separate respective lumens formed in the shaft 206.

[0096] The handle 204 of the delivery apparatus 200 can include one or more control mechanisms (for example, knobs or other actuating mechanisms) for controlling different components of the delivery apparatus 200 in order to expand and / or deploy the prosthetic valve 100. For example, in the illustrated example the handle 204 comprises first, second, and third knobs 211, 212, and 214, respectively. It should be appreciated that first, second, and third knobs 211, 212, and 214 can be located in any suitable position, including any suitable position relative to one another. For example, while handle 204 comprises a second knob 212 between first knob 211 and third knob 214, it is contemplated that a handle could comprise first, second, and / or third knobs, etc. in any suitable order.

[0097] The first knob 211 can be a rotatable knob configured to produce axial movement of the first shaft 206 relative to the prosthetic valve 100 in the distal and / or proximal directions in order to deploy the prosthetic valve from the delivery sheath 216 once the prosthetic valve has been advanced to a location at or adjacent the desired implantation location with the subject’s body. For example, rotation of the first knob 211 in a first direction (for example, clockwise) can retract the sheath 216 proximally relative to the prosthetic valve 100 and rotation of the first knob 211 in a second direction (for example, counter-clockwise) can advance the sheath 216 distally. In some examples, the first knob 211 can be actuated by sliding or moving the first knob 211 axially, such as pulling and / or pushing the knob. In some examples, actuation of the first knob 211 (rotation or sliding movement of the first knob 211) can produce axial movement of the actuator assemblies 208 (and therefore the prostheticTHVDL-13801W001 valve 100) relative to the delivery sheath 216 to advance the prosthetic valve distally from the sheath 216.

[0098] The second knob 212 can be a rotatable knob configured to produce radial expansion and / or compression of the prosthetic valve 100. For example, rotation of the second knob 212 can rotate the threaded rods of the prosthetic valve 100 via the actuator assemblies 208. Rotation of the second knob 212 in a first direction (for example, clockwise) can radially expand the prosthetic valve 100 and rotation of the second knob 212 in a second direction (for example, counter-clockwise) can radially collapse the prosthetic valve 100. In some examples, the second knob 212 can be actuated by sliding or moving the second knob 212 axially, such as pulling and / or pushing the knob.

[0099] The third knob 214 can be a rotatable knob operatively connected to a proximal end portion of each actuator assembly 208. The third knob 214 can be configured to retract an outer sleeve or support tube of each actuator assembly 208 to disconnect the actuator assemblies 208 from the proximal portions of the actuators of the prosthetic valve (for example, threaded rod). Once the actuator assemblies 208 are uncoupled from the prosthetic valve 100, the delivery apparatus 200 can be removed from the subject, leaving just the prosthetic valve 100 in the subject.

[0100] Referring to FIGS. 4-5, they illustrate how each of the threaded rods 126 of the prosthetic device 100 can be removably coupled to an actuator assembly 300 (for example, actuator assemblies 208) of a delivery apparatus (for example, delivery apparatus 200), according to one example. Specifically, FIG. 5 illustrates how one of the threaded rods 126 can be coupled to an actuator assembly 300, while FIG. 4 illustrates how the threaded rod 126 can be detached from the actuator assembly 300.

[0101] As introduced above, an actuator assembly 300 can be coupled to the head portion 131 of each threaded rod 126. The head portion 131 can be included at a proximal end portion 180 of the threaded rod 126 and can extend proximally past a proximal end of the second post 124 (FIG. 2A). The head portion 131 can comprise first and second protrusions 182 defining a channel or slot 184 between them, and one or more shoulders 186. As discussed above, the head portion 131 can have a width greater than a diameter of the inner bore of the second post 124 such that the head portion 131 is prevented from moving into the inner bore of the second post 124 and such that the head portion 131 abuts the outflow end 108 of the frame 102. In particular, the head portion 131 can abut an outflow apex 119b of the frame 102. The head portion 131 can be used to apply a distally -directed force to the second post 124, for example, during radial expansion of the frame 102.THVDL-13801W001

[0102] Each actuator assembly 300 can comprise a first actuation member configured as a support tube or outer sleeve 302 and a second actuation member configured as a driver 304. The driver 304 can extend through the outer sleeve 302. The outer sleeve 302 is shown transparently in FIGS. 4-5 for purposes of illustration. The distal end portions of the outer sleeve 302 and driver 304 can be configured to engage or abut the proximal end of the threaded rod 126 (for example, the head portion 131) and / or the frame 102 (for example, the apex 119b). The proximal portions of the outer sleeve 302 and driver 304 can be operatively coupled to the handle of a delivery apparatus (for example, handle 204). The delivery apparatus in this example can include the same features described previously for delivery apparatus 200. In particular examples, the proximal end portions of each driver 304 can be operatively connected to the knob 212 such that rotation of the knob 212 (clockwise or counterclockwise) causes corresponding rotation of the drivers 304. The proximal end portions of each outer sleeve 302 can be operatively connected to the knob 214 such that rotation of the knob 214 (clockwise or counterclockwise) causes corresponding axial movement of the sleeves 302 (proximally or distally) relative to the drivers 304. In some examples, the handle can include electric motors for actuating these components.

[0103] The distal end portion of the driver 304 can comprise a central protrusion 306 configured to extend into the slot 184 of the threaded rod 126, and one or more flexible elongated elements or arms 308 including protrusions or teeth 310 configured to be releasably coupled to the shoulders 186 of the threaded rod 126. The protrusions 310 can extend radially inwardly toward a longitudinal axis of the driver 304. As shown in FIGS. 4-5, the elongated elements 308 can be configured to be biased radially outward to an expanded state, for example, by shape setting the elements 308.

[0104] As shown in FIG. 5, to couple the actuator assembly 300 to the threaded rod 126, the driver 304 can be positioned such that the central protrusion 306 is disposed within the slot 184 (FIG. 4) and such that the protrusions 310 of the elongated elements 308 are positioned distally to the shoulders 186. As the outer sleeve 302 is advanced (for example, distally) over the driver 304, the sleeve 302 compresses the elongated elements 308 they abut and / or snap over the shoulders 186, thereby coupling the actuator assembly 300 to the threaded rod 126. Thus, the outer sleeve 302 effectively squeezes and locks the elongated elements 308 and the protrusions 310 of the driver 304 into engagement with (that is, over) the shoulders 186 of the threaded rod 126, thereby coupling the driver 304 to the threaded rod 126.

[0105] Because the central protrusion 306 of the driver 304 extends into the slot 184 of the threaded rod 126 when the driver 304 and the threaded rod 126 are coupled, the driver 304THVDL-13801W001 and the threaded rod 126 can be rotational locked such that they co-rotate. So coupled, the driver 304 can be rotated (for example, using knob 212 the handle of the delivery apparatus 200) to cause corresponding rotation of the threaded rod 126 to radially expand or radially compress the prosthetic device. The central protrusion 306 can be configured (for example, sized and shaped) such that it is advantageously spaced apart from the inner walls of the outer sleeve 302, such that the central protrusion 306 does not frictionally contact the outer sleeve 302 during rotation. Though in the illustrated example the central protrusion 306 has a substantially rectangular shape in cross-section, in some examples, the protrusion 306 can have any of various shapes, for example, square, triangular, oval, etc. The slot 184 can be correspondingly shaped to receive the protrusion 306.

[0106] The outer sleeve 302 can be advanced distally relative to the driver 304 past the elongated elements 308, until the outer sleeve 302 engages the frame 102 (for example, a second post 124 of the frame 102). The distal end portion of the outer sleeve 302 also can comprise first and second support extensions 312 defining gaps or notches 314 between the extensions 312. The support extensions 312 can be oriented such that, when the actuator assembly 300 is coupled to a respective threaded rod 126, the support extensions 312 extend partially over an adjacent end portion (for example, the upper end portion) of one of the second posts 124 on opposite sides of the post 124. The engagement of the support extensions 312 with the frame 102 in this manner can counter-act rotational forces applied to the frame 102 by the rods 126 during expansion of the frame 102. In the absence of a counter-force acting against these rotational forces, the frame can tend to “jerk” or rock in the direction of rotation of the rods when they are actuated to expand the frame. The illustrated configuration is advantageous in that outer sleeves, when engaging the proximal posts 124 of the frame 102, can prevent or mitigate such jerking or rocking motion of the frame 102 when the frame 102 is radially expanded.

[0107] To decouple the actuator assembly 300 from the prosthetic device 100, the sleeve 302 can be withdrawn proximally relative to the driver 304 until the sleeve 302 no longer covers the elongated elements 308 of the driver 304. As described above, the sleeve 302 can be used to hold the elongated elements 308 against the shoulders 186 of the threaded rod 126 since the elongated elements 308 can be naturally biased to a radial outward position where the elongated elements 308 do not engage the shoulders 186 of the threaded rod 126. Thus, when the sleeve 302 is withdrawn such that it no longer covers / constrains the elongated elements 308, the elongated elements 308 can naturally and / or passively deflect away from, andTHVDL-13801W001 thereby release from, the shoulders 186 of the threaded rod 126, thereby decoupling the driver 304 from the threaded rod 126.

[0108] The sleeve 302 can be advanced (moved distally) and / or retracted (moved proximally) relative to the driver 304 via a control mechanism (for example, knob 214) on the handle 204 of the delivery apparatus 200, by an electric motor, and / or by another suitable actuation mechanism. For example, the physician can turn the knob 214 in a first direction to apply a distally directed force to the sleeve 302 and can turn the knob 214 in an opposite second direction to apply a proximally directed force to the sleeve 302. Thus, when the sleeve 302 does not abut the prosthetic device and the physician rotates the knob 214 in the first direction, the sleeve 302 can move distally relative to the driver 304, thereby advancing the sleeve 302 over the driver 304. When the sleeve 302 does abut the prosthetic device, the physician can rotate the knob 214 in the first direction to push the entire prosthetic device distally via the sleeve 302. Further, when the physician rotates the knob 214 in the second direction the sleeve 302 can move proximally relative to the driver 304, thereby withdrawing / retracting the sleeve 302 from the driver 304.

[0109] FIG. 6 illustrates an example of a delivery apparatus 400. The delivery apparatus 400 can, for example, provide for manipulation of a radius of curvature of a shaft of the delivery apparatus 400 independent of an axial displacement of the shaft relative to other components of the delivery apparatus. For example, the shaft of the delivery apparatus 400 can be retracted relative to a prosthetic implant coupled to the delivery apparatus 400 via a shaft displacement mechanism, without altering the radius of curvature of the shaft. Similarly, the delivery apparatus 400 can enable the curvature of the shaft to be adjusted via a shaft adjustment mechanism, without altering the axial position of the shaft relative to the prosthetic implant.

[0110] Similar to delivery apparatus 200, a prosthetic device 500 (for example, mechanically-expandable prosthetic valves such as prosthetic valve 100 described herein, self-expandable prosthetic valves, balloon-expandable prosthetic valves, etc.) can be releasably coupled to the delivery apparatus 400. It should be understood that the delivery apparatus 400 and other delivery apparatuses disclosed herein can be used to implant prosthetic devices other than prosthetic valves, such as stents or grafts.

[0111] The delivery apparatus 400 in the illustrated example generally includes a handle 404, a first elongated shaft 406 extending distally from the handle 404 and at least one expansion mechanism 408 extending distally through the first shaft 406 (FIG. 7). As shown in FIGS. 11A-11C, the prosthetic device 500 can be coupled to the expansion mechanism 408. TheTHVDL-13801W001 expansion mechanism 408 can include any type of expansion mechanism suitable for an expandable prosthetic device (for example, any actuator assembly described herein, a balloon for a balloon-expandable prosthetic device, an inner shaft having a self-expandable prosthetic device disposed on an outer surface thereof, etc.). In some examples, the delivery apparatus 400 includes a second shaft 402 (FIG. 12) extending through the first shaft 406. In some examples, as depicted, the second shaft 402 is a multi-lumen shaft and an expansion mechanism 408 extends through each of the lumens of the second shaft 402. In some examples, the second shaft 402 and the expansion mechanism 408 are the same component (for example, when the expansion mechanism is an inner shaft having a self-expandable prosthetic device disposed on an outer surface thereof, etc.).

[0112] In some examples, a distal end portion 407 (FIGS. 11A-11C) of the shaft 406 can be sized to house the prosthetic device 500 in its radially compressed, delivery state (for example, as coupled to the expansion mechanism 408) during delivery of the prosthetic valve through the subject’s vasculature. In this manner, the distal end portion 407 of the shaft 406 functions as a delivery sheath or capsule for the prosthetic valve during delivery. Further details regarding delivery capsules and retraction of delivery capsules can be found, for example, in U.S. Provisional Application No. 63 / 322,974, filed March 23, 2022, which is incorporated by reference herein.

[0113] The handle 404 of the delivery apparatus 400 can include one or more control mechanisms (for example, knobs or other actuating mechanisms) for controlling different components of the delivery apparatus 400 to expand and / or deploy the prosthetic valve. For example, in the illustrated example the handle 404 comprises first and second knobs 411 and 412, respectively.

[0114] The first knob 411 (also referred to herein as a “flex knob”) can be a rotatable knob configured to aid in advancing the delivery shaft 406 to and / or positioning the delivery shaft 406 at a location at or adjacent a desired implantation location with the subject’s body. For example, the first knob 411 is configured to be adjusted by the user to flex, bend, twist, turn, and / or otherwise articulate the distal end portion 407 of the delivery shaft 406 to aid in advancing and / or positioning the delivery shaft 406 for deployment of the prosthetic valve at the implantation site. For example, rotation of the first knob 411 in a first direction (for example, clockwise) relative to the handle 404 can increase the curvature of the shaft 406 and rotation of the first knob 411 in a second direction (for example, counterclockwise) relative to the handle 404 can decrease the curvature of the shaft 406. In some examples, the first knob 411 can be actuated by sliding or moving the first knob 411. In some examples, the first knobTHVDL-13801W001411 can be actuated by sliding or moving the first knob 411 axially, such as pulling and / or pushing the knob.

[0115] The second knob 412 (also referred to herein as a “shaft displacement knob”) can be a rotatable knob configured to produce axial movement of the first shaft 406 relative to the prosthetic valve in the distal and / or proximal directions to deploy the prosthetic valve from the delivery shaft 406 once the prosthetic valve has been advanced to the location at or adjacent the desired implantation location. For example, rotation of the second knob 412 in a first direction (for example, clockwise) relative to the handle 404 can retract the shaft 406 proximally relative to the prosthetic valve and rotation of the second knob 412 in a second direction (for example, counterclockwise) relative to the handle 404 can advance the shaft 406 distally relative to the prosthetic valve. In some examples, the second knob 412 can be actuated by sliding or moving the second knob 412. In some examples, the second knob 412 can be actuated by sliding or moving the second knob 412 axially, such as pulling and / or pushing the knob.

[0116] In some examples, the handle 404 can include a third knob (also referred to herein as an “actuation knob”) that can be a rotatable and / or other knob configured to produce radial expansion and / or compression of the prosthetic valve. For example, in connection with mechanically-expandable prosthetic devices, rotation of the third knob can rotate actuators of the prosthetic valve via the expansion mechanisms 408. Rotation of the third knob in a first direction (for example, clockwise) relative to the handle 404 can radially expand the prosthetic valve and rotation of the third knob in a second direction (for example, counterclockwise) relative to the handle 404 can radially collapse the prosthetic valve. In some examples, the third knob can be actuated by sliding or moving the third knob. In some examples, the third knob can be actuated by sliding or moving the third knob axially, such as pulling and / or pushing the knob. In some examples, the third knob can be omitted, for example, in connection with balloon-expandable and / or self-expandable prosthetic devices.

[0117] Each of the first knob 411, the second knob 412, and the third knob can include and / or be any of a variety of structures configured to be selectively rotated relative to the handle 404 to yield the corresponding functionalities disclosed herein, examples of which include a dial, a rotary actuator, a control wheel, an adjustment ring, etc. In some examples, one, some and / or all knobs can include and / or be any of a variety of structures configured to be selectively actuated.

[0118] The handle 404 of the delivery apparatus 400 can include one or more indicators, such as indicator 416. The indicator 416 (also referred to herein as a “flex indicator”) can beTHVDL-13801W001 operatively coupled to a knob, for example, the first knob 411, and can be configured to indicate an amount of flex or curvature of the shaft 406 as the knob, for example, the first knob 411 is rotated relative to the handle 404, as described in more detail below. As shown, the indicator 416 can include indicia, such as alphanumeric characters, laterally aligned hashmarks, graphics, images, symbols, etc., and / or a combination thereof to visually indicate the amount of curvature of the shaft 406.

[0119] As shown in FIG. 6, the indicator 416 is positioned axially between the first knob 411 and the second knob 412. Specifically, the handle 404 includes a window 418 extending between the first knob 411 and the second knob 412 through which the indicator 416 is viewable. In some examples, as depicted, the second knob 412 is positioned proximal to the first knob 411 and is spaced apart in the axial direction from the first knob 411.

[0120] The handle 404 can also include an outer housing 420. As shown in FIG. 7, within the housing 420 and / or within one or more of the knobs 411, 412, etc., the handle 404 can include the expansion mechanisms 408, a displacement mechanism 422 for axially displacing the delivery shaft 406 relative to the expansion mechanisms 408, and an adjustment mechanism 424 for adjusting the flex or curvature of the delivery shaft 406. In some examples, some or all of the expansion mechanisms 408, a displacement mechanism 422 for axially displacing the delivery shaft 406 relative to the expansion mechanisms 408, and an adjustment mechanism 424 for adjusting the flex or curvature of the delivery shaft 406 can be partially and / or fully within the housing 420 and / or within one or more of the knobs 411, 412, etc. In some instances, the housing 420 can be integrally formed as a single, unitary component. In other instances, the housing 420 can comprise one or more segments that are formed as separate components that are coupled together (for example, via fasteners, adhesive, mating features, and / or other means for coupling). FIG. 8 depicts the delivery apparatus 400 with the outer housing 420 removed for purposes of illustration.

[0121] The displacement mechanism 422 is configured to axially displace the delivery shaft 406 relative to the expansion mechanisms 408, for example, to retract the delivery shaft 406 relative to the prosthetic device 500 coupled to the expansion mechanisms 408. As shown in FIGS. 7-8, the displacement mechanism 422 can include the second knob 412 and a carriage 426 (also referred to herein as a “displacement member 426”). As described in more detail below, rotation of the knob 412 relative to the handle 404 can drive axial displacement of the carriage 426 relative to the handle 404. As shown in FIG. 7, a proximal end 409 of the shaft 406 is coupled to the carriage 426, such that axial displacement of the carriage 426 causes axial displacement of the shaft 406. In this manner, the carriage 426 may be described asTHVDL-1380IW001 operating to carry the proximal end 409 of the shaft 406 though various axial positions relative to the handle 404 to yield corresponding displacement of the distal end of the shaft 406, such as to retract the delivery shaft 406 relative to the prosthetic device 500. In the present disclosure the carriage 426 additionally or alternatively may be referred to as a slider 426, a shaft displacement block 426, a shaft translation block 426, a shaft force transfer body 426, a sled 426, and / or a shuttle 426.

[0122] The knob 412 can include an outer grip portion 428 and an inner surface 430 that includes inner teeth (for example, as shown in FIG. 9). The grip portion 428 is configured to be engaged by a user to rotate the knob 412 relative to the handle 404. Rotation of knob 412 is configured to axially displace one or more components of the shaft displacement mechanism 422 (for example, the carriage 426) relative to the housing 420.

[0123] In some examples, the delivery apparatus 400 can also include one or more gear assemblies 432 to couple the knob 412 to the other components of the shaft displacement mechanism 422 disposed within the handle 404, as described in more detail below. For example, each gear assembly 432 can include one or more gears 434 and one or more lead screws 436.

[0124] As shown in FIG. 9, the gears 434 have teeth which are meshed with the teeth of the inner surface 430 of the knob 412 and / or teeth coupled to inner surface 430 of the knob. The gears 434 are coupled to the proximal ends of the lead screws 436 such that the gears 434 and the lead screws 436 rotate together. The lead screws 436 extend within the handle 404 along a length of the handle 404, for example, from the first knob 411 to the second knob 412, as shown in FIGS. 11A-11C. The lead screws 436 extend through threaded openings 438 of the carriage 426, as shown in FIG. 10. The lead screws 436 have a threaded outer surface which engages with the threaded openings 438 of the carriage 426.

[0125] As such, rotation of the knob 412 causes rotation of the gears 434, as the gears 434 are meshed with the teeth of the knob 412. As the gears 434 rotate, the lead screws 436 likewise rotate based on the fixed coupling therebetween. The threaded connection between the lead screws 436 and the openings 438 of the carriage 426 drive axial movement of the carriage 426 relative to the housing 420, which in turn drives axial movement of the shaft 406 (which is coupled to the carriage 426) relative to the prosthetic device 500. It is contemplated that any suitable mechanism can be used to cause rotation of the gears 434 and / or the lead screws 436.

[0126] In some examples, the outer housing 420 includes splines 421 on an inner surface of the outer housing 420, as shown in FIG. 10. The splines 421 match with correspondingTHVDL-13801W001 grooves 423 on the carriage 426, to prevent rotation between the carriage 426 and the outer housing 420 as the lead screws 436 drive axial movement of the carriage 426. In this manner, the splines 421 can prevent rotational movement of the carriage 426, while allowing the carriage 426 to move in an axial direction relative to the lead screws 436 and the outer housing 420.

[0127] In some examples, as depicted in FIG. 9, the shaft displacement mechanism 422 includes two groupings of one gear 434 and lead screw 436. For example, each grouping 432 (also referred to as “gear assembly 432”) is disposed in a circumferentially spaced apart manner. For example, each grouping 432 can be disposed in a circumferentially spaced apart manner, such that the gear assemblies 432 are equally spaced around the handle 404. While two gear assemblies 432 are included in the illustrated example, a different number of gear assemblies 432 (for example, one, three, four, etc.) can be included in other examples. In some examples, each gear assembly 432 can include a different configuration of gears and / or rods (e.g., lead screws) that operatively couple the knob 412 to the carriage 426.

[0128] FIGS. 11A-11C illustrate operation of the displacement mechanism 422 in greater detail. Specifically, FIGS. 11A-11C illustrate operation of the components of the displacement mechanism 422 disposed within the handle 404 and the displacement of the delivery shaft 406 relative to the prosthetic device 500.

[0129] FIG. 11 A illustrates the carriage 426 in a first axial position within the handle 404, for example, prior to rotation of the knob 412 in a first direction relative to the handle 404. FIG. 1 IB illustrates the carriage 426 in a second axial position within the handle 404, for example, after rotation of the knob 412 in the first direction. FIG. 11C illustrates the carriage 426 in a third axial position within the handle 404, for example, after further rotation of the knob 412 in the first direction. As shown, the first axial position is distal to the second axial position and the second axial position is distal to the third axial position. In some examples, rotation of the knob 412 in the first direction can result in proximal translation of the carriage 426, while rotation of the knob 412 in a second direction (for example, opposite from the first direction) relative to the handle 404 can result in distal translation of the carriage 426.

[0130] When the carriage 426 is in the first axial position (FIG. 11 A), the distal end portion 407 of the delivery shaft 406 is in a first position relative to the prosthetic device 500 and the expansion mechanisms 408, such that the distal end portion 407 of the shaft 406 surrounds or sheaths the prosthetic device 500. When the carriage 426 is in the second axial position (FIG. 11B), the distal end portion 407 of the delivery shaft 406 is in a second position relative to the prosthetic valve 100 and the expansion mechanisms 408. In the illustrated example, theTHVDL-13801W001 delivery shaft 406 is partially retracted relative to the prosthetic device 500 and the expansion mechanisms 408 in the second position. When the carriage 426 is in the third axial position (FIG. 11C), the distal end portion 407 of the delivery shaft 406 is in a third position relative to the prosthetic valve 100 and the expansion mechanisms 408. In the illustrated example, the delivery shaft 406 is fully retracted relative to the prosthetic device 500 and the expansion mechanisms 408 in the third position. As explained in more detail below, the shaft displacement mechanism 422 operates independently of the shaft adjustment mechanism 424, such that the shaft displacement mechanism 422 can he operated without altering the curvature of the shaft 406. In other words, operation of the shaft displacement mechanism 422 does not alter the tension on a pull wire 440 of the shaft adjustment mechanism 424. For example, the curvature of the delivery shaft 406 is substantially the same in the first position (FIG. 11 A) as in the second position (FIG. 1 IB). This can be useful, for example, when the prosthetic device 500 is to be implanted at a target location that requires the delivery shaft 406 to be curved during implantation of the prosthetic device 500, such as when the delivery shaft 406 is positioned within an aortic arch.

[0131] Rotation of the knob 412 can drive the displacement mechanism 422 to remove the distal end portion 407 of the shaft 406 from the prosthetic device 500. As one example, one revolution of the knob 412 can transition the shaft 406 from a fully sheathed state (e.g., FIG. 11 A) to a fully unsheathed state (e.g., FIG. 11C). In some examples, the gear ratio of the gear assembly 432 can be altered to require the knob 412 to move more or less than one revolution, for example, to move the shaft 406 from the fully sheathed to the fully sheathed configuration. Specifically, the number of teeth of the knob 412 and / or the number of teeth of the gear 434 can be altered such that a different number of revolutions of the knob 412 relative to the handle 404 are required to transition between the sheathed and fully unsheathed configurations. In some examples, the threaded connection between the lead screws 436 and the threaded openings 438 can be altered (e.g., adjust the pitch of the threads, etc.) to adjust the number of revolutions of the knob 412 required to transition the shaft 406 from the fully sheathed to the fully sheathed configuration. In this way, the displacement mechanism 422 can be altered to have fine adjustment (e.g., fewer revolutions of knob 412) or coarse adjustment (e.g., more revolutions of knob 412) of the displacement of the shaft 406.

[0132] As introduced above, the delivery apparatus 400 includes an adjustment mechanism 424 configured to adjust a radius of curvature of the shaft 406. The adjustment mechanism 424 can be operatively coupled to the first knob 411. In some examples, the distal end portionTHVDL-1380IW001407 of the delivery shaft 406 can be configured to be steerable via the adjustment mechanism 424 based on rotation of the first knob 411 relative to the housing 420. For example, by rotating the knob 411, a curvature of the distal end portion 407 of the delivery shaft 406 can be adjusted so that the distal end portion 407 of the delivery shaft 406 can be oriented in a desired curvature. Specifically, to implant the prosthetic device 500, the distal end portion 407 of the delivery shaft 406 can be steered so that the prosthetic device 500 can be positioned at a target implantation location.

[0133] Tn addition to the knob 41 1 , the adjustment mechanism 424 (also referred to herein as a “flex assembly”) can include a pull wire 440, as shown in FIG. 7. The adjustment mechanism 424 can be configured to steer the distal end portion 407 of the delivery shaft 406 via the knob 411 and the pull wire 440 by increasing or decreasing the tension of the pull wire 440. Specifically, a distal end of the pull wire 440 can be connected to the distal end portion 407 of the delivery shaft 406. When the tension of the pull wire 440 changes, the curvature of the distal end portion 407 of the delivery shaft 406 changes in response to the tension of the pull wire 440. The pull wire 440 can include and / or be any of a variety of structures and / or components for conveying a force (e.g., a tension force) to steer the distal end portion 407 of the delivery shaft 406, examples of which include a wire, a suture, a thread, a ribbon, a cord, and / or any other structure that is flexible to bending and resistant to axial stretching.

[0134] As shown in FIG. 12, the adjustment mechanism 424 can also include a flex element 442, a flex nut 444 and a flex screw 446 to axially displace the pull wire 440 relative to the handle 404. For example, the pull wire 440 can extend proximally into the handle 404 and a proximal end of the pull wire 440 can be connected to the flex element 442. As described in more detail below, the flex element 442 and the flex nut 444 can be configured to translate axially relative to the flex screw 446 to adjust the tension of the pull wire 440.

[0135] In some examples, the delivery apparatus 400 can also include a gear assembly 448 to couple the knob 411 to the other components of the adjustment mechanism 424 disposed within the handle 404, as described in more detail below. For example, as shown in FIG. 14, the gear assembly 448 can include one or more gears 450 and one or more rods 452.

[0136] As shown in FIG. 13, the proximal end of the pull wire 440 is coupled to the flex element 442. In some examples, the flex element 442 can comprise a plate, rod, shaft, or other suitable element that is coupled to the proximal end of the pull wire 440 and is configured to translate relative to the carriage 426. In some examples, as depicted, the flex element 442 is a plate that includes a main body 454 having a portion, for example, aTHVDL-13801W001 narrowed portion 456, around which the pull wire 440 is wrapped. As such, the flex element 442 can also be referred to herein as flex plate 442. The main body 454 also includes one or more openings 458 through which the proximal end of the pull wire 440 is inserted. The flex plate 442 can also include arms 460 extending distally from the main body 454, for example, on either side of the main body 454. The flex plate 442 can be configured to secure a proximal end of the pull wire 440 thereto (for example, by wrapping an end of the pull wire 440 around the narrowed portion 456 of the flex plate 442, etc.). The pull wire 440 can be wrapped around the narrowed portion 456 to couple the pull wire 440 to the flex plate 442 and the proximal end of the pull wire 440 can be inserted through the opening 458 to prevent the pull wire 440 from disconnecting or unwrapping from the flex plate 442. In some examples, wrapping the pull wire 440 around the narrowed portion 456 can result in plastic deformation of the pull wire 440. In this way, the plastic deformation of the pull wire 440 can help to prevent the pull wire 440 from disconnecting or unwrapping from the flex plate 442.

[0137] In some examples, the pull wire can be coupled to the flex plate in various other ways. For example, fasteners, adhesive, and / or other means of coupling can be used to couple the pull wire to the flex plate. In some examples, the pull wire 440 can include and / or be any of a variety of structures for conveying a force (e.g., a tension force), and can be any suitable size, shape, and material(s).

[0138] As shown in FIG. 12, the flex plate 442, the flex nut 444 and the flex screw 446 are coupled to the carriage 426. For example, the flex plate 442 is disposed within a slot 462 of the carriage 426. The flex plate 442 can be configured to translate axially relative to the carriage 426 within the slot 462 to adjust the tension of the pull wire 440. In some examples, as described in more detail below, rotation of the flex screw 446 can result in the axial translation of the flex plate 442 relative to the carriage 426.

[0139] In some examples, as shown in FIG. 12, the flex nut 444 includes internal threads 464 that can be mated with external threads 466 of the flex screw 446. As described in more detail below, the flex nut 444 is permitted to translate axially along the flex screw 446 along the threads 466 of the outer surface, based on rotation of the first knob 411 relative to the handle 404.

[0140] The flex nut 444 can include projections 468 that extend radially inwards into the slot 462. Specifically, the projections 468 of the flex nut 444 can extend between the arms 460 of the flex plate 442, such that the projections 468 are distal to the main body 454 of the flex plate 442. When the flex nut 444 is driven axially by the flex screw 446, the projections 468THVDL-13801W001 are configured to push the flex plate 442 axially within the slot 462, for example, in a proximal direction.

[0141] As shown in FIG. 14, the knob 411 can include an outer grip portion 470 and an inner surface 472 that includes inner teeth. The grip portion 470 is configured to be engaged by a user to rotate the knob 411 relative to the handle 404. Rotation of knob 411 is configured to axially displace one or more components of the adjustment mechanism 424 (for example, the flex plate 442) relative to the carriage 426.

[0142] As shown in FIG. 14, the gear 450 has teeth which are meshed with the teeth of the inner surface 472 of the knob 411. The gear 450 is coupled to the distal end of the rod 452, such that the gear 450 is not permitted to rotate relative to the rod 452. For example, the rod 452 can be shaped (for example, D-shaped) such that the rod 452 mates with a corresponding opening of the gear 450. As shown in FIG. 12, the flex screw 446 is also coupled to the rod 452, such that the flex screw 446 is not permitted to rotate relative to the rod 452. The flex screw 446 is configured to translate relative to the rod 452, for example, when the carriage 426 is driven axially by the second knob 412, as described above in connection with the shaft adjustment mechanism 424.

[0143] As shown in FIG. 15, in the example illustrated, rotation of the knob 411 causes rotation of the gear 450, as the gear 450 is meshed with the teeth of the knob 411. As the gear 450 rotates, the flex screw 446 likewise rotates based on the coupling between the gear 450, the rod 452, and the flex screw 446. As the flex screw 446 is rotated, the threaded connection between the flex screw 446 and the flex nut 444 drives axial movement of the flex nut 444 relative to the carriage 426. As the flex nut 444 is driven axially, the projections 468 of the flex nut 444 push against the main body 454 of the flex plate 442, which in turn drives axial movement of the flex plate 442 relative to the housing 420, thus increasing the tension of the pull wire 440.

[0144] FIGS. 16A-16C illustrate operation of the adjustment mechanism 424 in greater detail. Specifically, FIGS. 16A-16C illustrate operation of the components of the adjustment mechanism 424 disposed within the handle 404.

[0145] FIG. 16A illustrates the flex plate 442 and the flex nut 444 in a first axial position relative to the carriage 426, for example, prior to rotation of the knob 411 in a first direction relative to the handle 404. In some examples, the shaft 406 is unflexed when the flex plate 442 and the flex nut 444 are in the first axial position, as shown in FIG. 16A. FIG. 16B illustrates the flex plate 442 and the flex nut 444 in a second axial position relative to the carriage 426, for example, after rotation of the knob 411 in the first direction. In someTHVDL-13801W001 examples, the shaft 406 is at least partially flexed when the flex plate 442 and the flex nut 444 are in the second axial position, as shown in FIG. 16B. FIG. 16C illustrates the flex plate 442 in the second axial position and the flex nut 444 in the first axial position relative to the carriage 426, for example, after rotation of the knob 411 in a second direction relative to the handle 404, opposite the first direction. As shown, the first axial position is distal to the second axial position. In some examples, rotation of the knob 411 in the first direction can result in proximal translation of the flex nut 444, while rotation of the knob 411 in the second direction (for example, opposite from the first direction) relative to the handle 404 can result in distal translation of the flex nut 444.

[0146] In the example illustrated, when the flex plate 442 and the flex nut 444 are in the first axial position (e.g., FIG. 16A), the distal end portion 407 of the delivery shaft 406 is unflexed. When the flex plate 442 and the flex nut 444 are in the second axial position (e.g., FIG. 16B), the distal end portion 407 of the delivery shaft 406 is at least partially flexed. In some examples, the flex plate 442 can be fixedly coupled to the flex nut 444, such that the flex plate 442 and the flex nut 444 move together proximally and distally (e.g., between the first axial position and the second axial position). In some examples, as shown, e.g., in FIG. 16C, the flex nut 444 moves distally (e.g., toward the first axial position) while the flex plate 442 remains in the second axial position such that the distal end portion of the delivery shaft406 remains at least partially flexed. This can occur, for example, when the distal end portion407 of the delivery shaft 406 is positioned within a portion of the native anatomy that prevents the distal end portion 407 of the delivery shaft 406 from unflexing when the knob 211 is rotated in the second direction (e.g., rotated to unflex the distal end portion 407 of the delivery shaft 406).

[0147] The flex nut 444 is configured to drive the flex plate 442 in one direction (e.g., proximally) and allow the flex plate 442 to return in the opposite direction (e.g., distally), for example, when the native anatomy allows. In this way, the flex nut 444 does not force the flex plate 442 to return distally, which can, for example, prevent the pull wire 440 from compressing, kinking, and / or otherwise becoming damaged. When the native anatomy allows, the distal end portion 407 of the shaft 406, which, in some examples, is biased towards an unflexed state (e.g., based on the configuration (e.g., material properties) of the shaft 406), will return to the unflexed position and the flex plate 442 and pull wire 440 will return to contact with the flex plate 442 (e.g., FIG. 16A).

[0148] When the native anatomy allows unflexing of the distal end portion 407 of the delivery shaft 406, the adjustment mechanism 424 transitions between the configurationsTHVDL-13801W001 shown in FIG. 16A (unflexed) and FIG. 16B (flexed), such that the flex plate 442 translates distally when the flex nut 444 translates distally. When the native anatomy prevents unflexing of the distal end portion 407 of the delivery shaft 406, the adjustment mechanism 424 transitions to the configuration shown in FIG. 16C before returning to the unflexed position of FIG. 16 A, such that the flex plate 442 remains in the second axial position, which is spaced apart from the flex nut 444 in the first axial position, until the native anatomy allows unflexing of the distal end portion 407 of the delivery shaft 406.

[0149] As explained above, the shaft adjustment mechanism 424 and the shaft displacement mechanism 422 operate independently of each other, such that the curvature of the shaft 406 can be adjusted by the adjustment mechanism 424 without altering the axial position of the shaft 406 relative to the prosthetic device 500. For example, the different flex configurations of the adjustment mechanism 424 of FIGS. 16A-16C can occur independent of the axial position of the carriage 426 relative to the handle 404.

[0150] To indicate the amount of curvature of the distal end portion 407 of the delivery shaft 406, the delivery apparatus 400 includes an indicator 416 which is operatively coupled to the adjustment mechanism 424. Specifically, as shown in FIGS. 6 and 8, the indicator 416 includes a display 474 which can include indicia, such as alphanumeric characters, laterally aligned hashmarks, graphics, images, symbols, etc., and / or a combination thereof to visually indicate the amount of curvature of the shaft 406. The display 474 is coupled to the carriage 426. As such, the indicator 416 is configured to translate axially as the carriage 426 is displaced by the shaft displacement mechanism 422, as described above. Because of the length of the window 418, the indicator 416 remains visible through the window 418 regardless of the axial position of the carriage 426.

[0151] The indicator 416 also includes a slider 476 which is configured to specify the indicia which corresponds to the amount of curvature of the shaft 406, for example, by translating axially relative to the carriage 426. As shown in FIG. 10, the slider 476 is coupled to the flex nut 444, such that axial translation of the flex nut 444 drives axial movement of the slider 476. In this way, rotation of the knob 411 (e.g., in a first direction) causes axial translation of the flex nut 444 which both increases the tension of the pull wire 440 and adjusts the position of the slider 476 relative to the display 474 of the indicator 416. In some examples, it is contemplated that the slider 476 can be coupled to any component(s) of the flex assembly (e.g., a flex nut, a flex plate, etc.).

[0152] Rotation of the knob 411 can drive both the adjustment mechanism 424 and the indicator 416. As one example, one revolution of the knob 411 can transition the shaft 406THVDL-13801W001 from an unflexed state to a fully flexed state and can indicate the full range of curvature of the shaft 406. In some examples, the gear ratio of the gear assembly 448 can be altered such that the knob 411 rotates more or less than one revolution, for example, to move the shaft 406 from an unflexed to a fully flexed configuration and to move the indicator 416 along the full range of the display 474. Specifically, the number of teeth of the knob 411 and / or the number of teeth of the gear 450 can be altered such that a different number of revolutions of the knob 411 relative to the handle 404 is required to transition the shaft 406 between the unflexed and fully flexed configurations. In some examples, the threaded connection between the flex nut 444 and the flex screw 446 can be altered (e.g., adjust the pitch of the threads, etc.) to adjust the number of revolutions of the knob 411 required to transition the shaft 406 from an unflexed state to a fully flexed state and to indicate the full range of curvature of the shaft 406. In this way, the adjustment mechanism 424 can be altered to have fine adjustment (e.g., fewer revolutions of knob 411) or coarse adjustment (e.g., more revolutions of knob 411) of the curvature of the shaft 406 and the corresponding indication by the indicator 416.

[0153] The delivery apparatus 400 can include one or more fluid ports that can allow a flushing fluid to flow into and / or between specific components of the delivery apparatus 400 that are required to be flushed. For example, as shown in FIG. 17, the distal end of the handle 404 includes a first fluid port 478. The fluid port 478 extends through a nose cone 480 of the handle 404 and a distal base 482 that is disposed within the nose cone 480 and within the knob 411. As shown in FIG. 17, the distal ends of the lead screws 436 are coupled to the distal base 482, such that the lead screws 436 are permitted to rotate relative to the distal base 482.

[0154] In some examples, the delivery apparatus 400 can include an optional stabilizer 484 coupled to the distal end of the handle 404. The stabilizer 484 is configured to stabilize and / or reinforce the shaft 406 at the distal end of the handle 404, for example, to prevent the shaft 406 from bending and / or becoming damaged at the location where the shaft 406 enters the handle 404 (e.g., at the nose cone 480). The shaft 406 extends through the stabilizer 484, as shown in FIG. 17. The fluid port 478 is in fluid communication with a lumen of the stabilizer 484 to allow a flushing fluid to flow into the lumen, between an outer surface of the shaft 406 and an inner surface of the stabilizer 484. One or more O-rings 486 can be positioned around the outer surface of the shaft 406 within the distal base 482 to prevent the flushing fluid from flowing proximally through the handle 404.

[0155] The delivery apparatus 400 can also include a second fluid port 488 (FIGS. 7 and 19) that is configured to allow a flushing fluid to flow between an outer surface of the secondTHVDL-13801W001 shaft 402 and an inner surface of the first shaft 406. Specifically, as shown in FIGS. 7 and 19, the fluid port 488 is positioned adjacent to the knob 412 and extends through a proximal base 490 of the handle 404. A flush rod 492 is coupled to the proximal base 490 and includes a central lumen 494 extending the length of the flush rod 492. The fluid port 488 is in fluid communication with the central lumen 494 of the flush rod 492. As shown in FIG. 7, the proximal end of the rod 452 is also coupled to the proximal base 490, such that the rod 452 is permitted to rotate relative to the proximal base 490 (for example, during operation of the adjustment mechanism 424 as described above). The flush rod 492 extends distally from the proximal base 490 through the carriage 426 to the distal base 482, where the flush rod 492 is coupled to the distal base 482. The flush rod 492 is coupled to the distal base 482 and the proximal base 490, such that the flush rod 492 is fixed relative to the housing 420 of the handle 404.

[0156] As shown in FIGS. 18A-18B, the flush rod 492 extends through a chamber 496 of the carriage 426. A sheath 498 is disposed within the chamber 496 and extends along the length of the chamber 496 around the flush rod 492. The sheath 498 includes a plurality of openings to allow a flushing fluid to flow from an inner surface of the sheath 498 through to an exterior surface of the sheath 498. A passageway 502 extends from the chamber 496 and connects the chamber 496 to the area between an outer surface of the second shaft 402 and an inner surface of the first shaft 406. In some examples, as shown, the passageway 502 is positioned proximal to the proximal end 409 of the first shaft 406. In this way, the flushing fluid can enter the lumen of the first shaft 406 from the proximal end 409 of the shaft 406.

[0157] The flush rod 492 includes an opening 504 extending from the central lumen 494 to an outer surface of the flush rod 492. As shown in FIGS. 18A-18B, the opening 504 is spaced apart in the axial direction from the distal end of the flush rod 492. During operation of the displacement mechanism 422, the carriage 426 is configured to translate axially relative to the flush rod 492. Because of the positioning of the opening 504, the system can be flushed at different configurations of the displacement mechanism 422, such as when the carriage 426 is at various axial positions relative to the flush rod 492. When the carriage 426 is positioned in a first axial position relative to the flush rod (see, e.g., FIG. 18 A), the opening 504 of the flush rod 492 is positioned more proximally within the chamber 496 relative to its position when the carriage 426 is in the second axial position (see, e.g., FIG. 18B). In this position, a flushing fluid is permitted to flow through the fluid port 488, through the flush rod 492, out of the opening 504, into the chamber 496, through the openings of the sheath 498, through the passageway 502 and between the first shaft 406 and the second shaft 402. In the first axialTHVDL-1380IW001 position (FIG. 18A), the distal end portion 407 of the shaft 406 is positioned around the prosthetic device 500 (FIG. HA).

[0158] When the carriage 426 is positioned in a second axial position relative to the flush rod 492 (see, e.g., FIG. 18B), the opening 504 of the flush rod 492 is positioned more distally within the chamber 496 relative to its position when the carriage 426 is in the first axial position (see, e.g., FIG. 18 A). Because the opening 504 is still positioned within the chamber 496, the flushing fluid is again permitted to flow through the fluid port 488, through the flush rod 492, out of the opening 504, into the chamber 496, through the openings of the sheath 498, through the passageway 502 and between the first shaft 406 and the second shaft 402. In the second axial position relative to the flush rod 492, the distal end portion 407 of the shaft 406 is at least partially retracted from the prosthetic device 500 (e.g., FIG. 1 IB). In some examples, it is useful for the system to be flushed when the carriage 426 is in the first axial position and the second axial position relative to the flush rod 492, for example, to allow flushing in different axial positions of the distal end portion 407 of the shaft 406 relative to the prosthetic device 500 (see e.g., FIGS. 11A-1 IB) which may provide for easier and / or more complete flushing.

[0159] One or more O-rings 486 can be positioned around the outer surface of the second shaft 402 within the carriage 426 to prevent the flushing fluid from flowing proximally through the handle 404. One or more O-rings 486 can be positioned within the chamber 496 around the outer surface of the flush rod 492 to prevent the flushing fluid from flowing out of the carriage 426.

[0160] In some of the axial positions of the carriage 426, the opening 504 of the flush rod 492 is not within the chamber 496, such that the fluid path from the fluid port 588 to the first and second shafts 402, 406 is broken (see e.g., FIG. 12). This can occur, for example, when the distal end portion 407 of the shaft 406 is fully retracted (FIG. 11C).

[0161] In some examples, the delivery apparatus 400 can also include a third fluid port 506 configured to allow a flushing fluid to flow between the second shaft 402 and the expansion mechanisms 408. For example, as shown in FIG. 19, the fluid port 506 extends through the proximal base 490 and is in fluid communication with the space between an outer surface of the expansion mechanisms 408 and an inner surface of each lumen of the second shaft 402. Delivery Techniques

[0162] For implanting a prosthetic valve within the native aortic valve via a transfemoral delivery approach, in an example, the prosthetic valve is mounted in a radially compressed state along the distal end portion of a delivery apparatus. The prosthetic valve and the distalTHVDL-13801W001 end portion of the delivery apparatus are inserted into a femoral artery and are advanced into and through the descending aorta, around the aortic arch, and through the ascending aorta. The prosthetic valve is positioned within the native aortic valve and radially expanded (e.g., by inflating a balloon, actuating one or more actuators of the delivery apparatus, or deploying the prosthetic valve from a sheath to allow the prosthetic valve to self-expand). Additionally or alternatively, a prosthetic valve can be implanted within the native aortic valve in a transapical procedure, whereby the prosthetic valve (on the distal end portion of the delivery apparatus) is introduced into the left ventricle through a surgical opening in the chest and the apex of the heart and the prosthetic valve is positioned within the native aortic valve. Additionally or alternatively, in a transaortic procedure, a prosthetic valve (on the distal end portion of the delivery apparatus) is introduced into the aorta through a surgical incision in the ascending aorta, such as through a partial J-stemotomy or right parasternal minithoracotomy, and then advanced through the ascending aorta toward the native aortic valve.

[0163] For implanting a prosthetic valve within the native mitral valve via a transseptal delivery approach, the prosthetic valve is mounted in a radially compressed state along the distal end portion of a delivery apparatus. The prosthetic valve and the distal end portion of the delivery apparatus are inserted into a femoral vein and are advanced into and through the inferior vena cava, into the right atrium, across the atrial septum (through a puncture made in the atrial septum), into the left atrium, and toward the native mitral valve. Additionally or alternatively, a prosthetic valve can be implanted within the native mitral valve in a transapical procedure, whereby the prosthetic valve (on the distal end portion of the delivery apparatus) is introduced into the left ventricle through a surgical opening in the chest and the apex of the heart and the prosthetic valve is positioned within the native mitral valve.

[0164] For implanting a prosthetic valve within the native tricuspid valve, the prosthetic valve is mounted in a radially compressed state along the distal end portion of a delivery apparatus. The prosthetic valve and the distal end portion of the delivery apparatus are inserted into a femoral vein and are advanced into and through the inferior vena cava, and into the right atrium, and the prosthetic valve is positioned within the native tricuspid valve. A similar approach can be used for implanting the prosthetic valve within the native pulmonary valve or the pulmonary artery, except that the prosthetic valve is advanced through the native tricuspid valve into the right ventricle and toward the pulmonary valve / pulmonary artery.

[0165] Another delivery approach is a transatrial approach whereby a prosthetic valve (on the distal end portion of the delivery apparatus) is inserted through an incision in the chestTHVDL-13801W001 and an incision made through an atrial wall (of the right or left atrium) for accessing any of the native heart valves. Atrial delivery can also be made intravascularly, such as from a pulmonary vein. Still another delivery approach is a transventricular approach whereby a prosthetic valve (on the distal end portion of the delivery apparatus) is inserted through an incision in the chest and an incision made through the wall of the right ventricle (typically at or near the base of the heart) for implanting the prosthetic valve within the native tricuspid valve, the native pulmonary valve, or the pulmonary artery.

[0166] In all delivery approaches, the delivery apparatus can be advanced over a guidewire previously inserted into a subject’s vasculature. Moreover, the disclosed delivery approaches are not intended to be limited. Any of the prosthetic valves disclosed herein can be implanted using any of various deliver)' procedures and delivery devices known in the art.

[0167] Any of the systems, devices, apparatuses, etc. herein can be sterilized (for example, with heat / thermal, pressure, steam, radiation, and / or chemicals, etc.) to ensure they are safe for use with subjects such as human patients, and any of the methods herein can include sterilization of the associated system, device, apparatus, etc. as one of the steps of the method. Examples of heat / thermal sterilization include steam sterilization and autoclaving. Examples of radiation usable and / or for use in sterilization include, without limitation, gamma radiation, ultra-violet radiation, and electron beam. Examples of chemicals usable and / or for use in sterilization include, without limitation, ethylene oxide, hydrogen peroxide, peracetic acid, formaldehyde, and glutaraldehyde. Sterilization with hydrogen peroxide may be accomplished using hydrogen peroxide plasma, for example.

[0168] 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.Additional Examples of the Disclosed Technology

[0169] In view of the above-described implementations of the disclosed subject matter, this application discloses the additional examples enumerated below. It should be noted that one feature of an example in isolation or more than one feature of the example taken in combination and, optionally, in combination with one or more features of one or more further examples are further examples also falling within the disclosure of this application.THVDL-13801W001

[0170] Example 1. A delivery apparatus for a prosthetic implant, the delivery apparatus comprising: a handle body; a shaft extending distally from the handle body, the shaft having a distal end and a proximal end; a shaft displacement mechanism coupled to the handle body, the shaft displacement mechanism comprising a carriage configured to translate axially relative to the handle body, wherein the proximal end of the shaft is coupled to the carriage; a shaft adjustment mechanism coupled to the handle body, the adjustment mechanism configured to adjust a curvature of the shaft, the shaft adjustment mechanism comprising a flex element and a pull wire, wherein the flex element is configured to translate axially relative to the carriage, wherein the pull wire has a distal end and a proximal end, wherein the distal end of the pull wire is coupled to a distal end portion of the shaft, for example, the distal end of the shaft, wherein a proximal end of the pull wire is coupled to the flex element; a first knob operatively coupled to the shaft displacement mechanism and rotatable relative to the handle body, wherein rotating the first knob relative to the handle body simultaneously axially displaces the shaft and the pull wire relative to the handle body; and a second knob operatively coupled to the shaft adjustment mechanism and rotatable relative to the handle body, wherein the second knob is spaced apart from the first knob in the axial direction, wherein rotating the second knob relative to the handle body adjusts the curvature of the shaft independent of an axial displacement of the shaft.

[0171] Example 2. The delivery apparatus of any example herein, particularly example 1, wherein the shaft displacement mechanism further comprises at least one lead screw operatively coupled to the carriage.

[0172] Example 3. The delivery apparatus of any example herein, particularly either example 1 or example 2, wherein the flex element comprises a plate.

[0173] Example 4. The delivery apparatus of any example herein, particularly any one of examples 1-3, wherein the carriage includes a slot, and wherein the flex element is disposed in the slot and configured to translate axially relative to the carriage within the slot.

[0174] Example 5. The delivery apparatus of any example herein, particularly any one of examples 1-4, wherein the shaft adjustment mechanism further comprises a flex nut and a flex screw, wherein the flex nut is coupled to the flex screw, wherein rotation of the flex screw drives axial translation of the flex nut.

[0175] Example 6. The delivery apparatus of any example herein, particularly example 5, wherein the flex nut comprises at least one projection.

[0176] Example 7. The delivery apparatus of any example herein, particularly any one of examples 1-6, further comprising an indicator disposed on the carriage and operativelyTHVDL-13801W001 coupled to the shaft adjustment mechanism, wherein the indicator is configured to indicate the curvature of the shaft upon rotation of the second knob.

[0177] Example 8. The delivery apparatus of any example herein, particularly any one of examples 1-7, wherein the shaft is configured to encapsulate the prosthetic implant, wherein the prosthetic implant comprises a prosthetic heart valve or a stent.

[0178] Example 9. The delivery apparatus of any example herein, particularly any one of examples 1-8, wherein the prosthetic implant is self-expandable, balloon-expandable, and / or mechanically-expandahle.

[0179] Example 10. The delivery apparatus of any example herein, particularly any one of examples 1-9, further comprising an expansion mechanism disposed within the shaft and configured to couple to the prosthetic implant, wherein the expansion mechanism comprises one of: at least one actuator assembly for mechanical expansion of the prosthetic implant and / or an inflatable balloon catheter for balloon expansion of the prosthetic implant.

[0180] Example 11. The delivery apparatus of any example herein, particularly any one of examples 1-10, wherein the carriage comprises one or more of a slider, a block, a sled, or a shuttle.

[0181] Example 12. The delivery apparatus of any example herein, particularly any one of examples 1-11, wherein the flex element comprises one or more of a plate, a rod, or a shaft.

[0182] Example 13. The delivery apparatus of any example herein, particularly any one of examples 1-12, wherein the pull wire comprises one or more of a wire, a suture, a thread, a ribbon, or a cord.

[0183] Example 14. The delivery apparatus of any example herein, particularly any one of examples 1-13, wherein one or both of the first knob and the second knob comprises one or more of a dial, a rotary actuator, a control wheel, or an adjustment ring.

[0184] Example 15. A delivery apparatus for a prosthetic implant, the delivery apparatus comprising: a handle body; a shaft extending distally from the handle body, the shaft having a distal end and a proximal end; a shaft displacement mechanism coupled to the handle body, the shaft displacement mechanism comprising a carriage configured to translate axially relative to the handle body, wherein the proximal end of the shaft is coupled to the carriage; a shaft adjustment mechanism coupled to the handle body, the adjustment mechanism configured to adjust a curvature of the shaft, the shaft adjustment mechanism comprising a flex nut, a flex plate, and a pull wire having a distal end and a proximal end, wherein the flex nut and the flex plate are configured to translate axially relative to the carriage, wherein the distal end of the pull wire is coupled to the distal end of the shaft, wherein the proximal endTHVDL-13801W001 of the pull wire is coupled to the flex plate, wherein translation of the flex nut in a proximal direction drives translation of the flex plate in the proximal direction from a first axial position to a second axial position, wherein translation of the flex nut in a distal direction allows the flex plate to remain in the second axial position or return to the first axial position; a first knob operatively coupled to the shaft displacement mechanism and rotatable relative to the handle body, wherein rotating the first knob relative to the handle body simultaneously axially displaces the shaft and the pull wire relative to the handle body; and a second knob operatively coupled to the shaft adjustment mechanism and rotatable relative to the handle body, wherein rotating the second knob relative to the handle body adjusts the curvature of the shaft independent of an axial displacement of the shaft.

[0185] Example 16. The delivery apparatus of any example herein, particularly example 15, wherein the carriage comprises a slot extending axially along a length of the carriage, wherein the flex plate is disposed within the slot.

[0186] Example 17. The delivery apparatus of any example herein, particularly example 15, wherein the Ilex nut comprises at least one projection extending into the slot.

[0187] Example 18. The delivery apparatus of any example herein, particularly example 17, wherein the flex plate comprises a main body and arms extending from the main body, wherein the proximal end of the pull wire is coupled to the main body, and wherein the at least one projection of the flex nut extends between the arms of the flex plate when the flex plate is in the first axial position.

[0188] Example 19. The delivery apparatus of any example herein, particularly either example 17 or example 18, wherein the at least one projection contacts the flex plate when the flex nut drives translation of the flex plate from the first axial position to the second axial position.

[0189] Example 20. A delivery apparatus for a prosthetic implant, the delivery apparatus comprising: a handle body; a shaft extending distally from the handle body, the shaft having a lumen, a distal end and a proximal end; a shaft displacement mechanism coupled to the handle body, the shaft displacement mechanism comprising a carriage, wherein the proximal end of the shaft is coupled to the carriage; a shaft adjustment mechanism coupled to the handle body, the adjustment mechanism configured to adjust a curvature of the shaft, the shaft adjustment mechanism comprising a flex element configured to translate axially relative to the carriage and a pull wire having a distal end and a proximal end, wherein the distal end of the pull wire is coupled to the distal end of the shaft, wherein a proximal end of the pull wire is coupled to the flex element; a flush rod extending through the carriage, wherein theTHVDL-13801W001 carriage is configured to translate axially relative to the flush rod between a first axial position relative to the flush rod and a second axial position relative to the flush rod, the flush rod including a flush lumen extending along a length of the flush rod and an opening in fluid communication with the flush lumen, wherein the opening is in fluid communication with the lumen of the shaft when the carriage is in the first axial position and the second axial position; a first knob operatively coupled to the shaft displacement mechanism and rotatable relative to the handle body, wherein rotating the first knob relative to the handle body simultaneously axially displaces the shaft and the pull wire relative to the handle body; and a second knob operatively coupled to the shaft adjustment mechanism and rotatable relative to the handle body, wherein rotating the second knob relative to the handle body adjusts the curvature of the shaft independent of an axial displacement of the shaft.

[0190] Example 21. The delivery apparatus of any example herein, particularly example 20, wherein the opening is spaced apart in the axial direction from a distal end of the flush rod.

[0191] Example 22. The delivery apparatus of any example herein, particularly either example 20 or example 21, further comprising a flush port coupled to the handle body, wherein the flush port is in fluid communication with the flush lumen.

[0192] Example 23. The delivery apparatus of any example herein, particularly any one of examples 20-22, wherein the carriage comprises a chamber, wherein the flush rod extends through the chamber, and further comprising a sheath comprising a plurality of openings disposed within the chamber around the flush rod.

[0193] Example 24. The delivery apparatus of any example herein, particularly any one of examples 20-23, wherein the shaft is configured to encapsulate the prosthetic implant when the carriage is in the first axial position, wherein the prosthetic implant comprises a prosthetic heart valve or a stent.

[0194] Example 25. The delivery apparatus of any example herein, particularly any one of examples 20-24, wherein the prosthetic implant is self-expandable, balloon-expandable, and / or mechanically-expandable.

[0195] Example 26. A method of implanting a prosthetic device at a target implantation location within a subject, the method comprising: advancing a delivery shaft of a delivery apparatus through the subject’s vasculature to position the prosthetic device at a target implantation location, wherein the prosthetic device is at least partially received within a distal end portion of the delivery shaft; and retracting the distal end portion of the delivery shaft proximally relative to the prosthetic device, wherein the advancing the delivery shaft through the subject’s vasculature comprises operating a shaft adjustment mechanism to adjustTHVDL-13801W001 a curvature of the delivery shaft, wherein the retracting the distal end portion of the delivery shaft comprises operating a shaft displacement mechanism to move the delivery shaft relative to the prosthetic device without altering the curvature of the delivery shaft.

[0196] Example 27. The method of any example herein, particularly example 26, wherein the operating the shaft adjustment mechanism comprises actuating a first knob of the delivery apparatus to vary a tension of a pull wire attached to the distal end portion of the delivery shaft, and wherein the operating the shaft displacement mechanism comprises actuating a second knob of the delivery apparatus to axially translate a carriage that is coupled to a proximal end portion of the shaft.

[0197] Example 28. The method of any example herein, particularly example 27, wherein the operating the shaft displacement mechanism does not alter the tension in the pull wire.

[0198] Example 29. The method of any example herein, particularly any one of examples 26-28, wherein the operating the shaft adjustment mechanism operates to adjust the curvature of the delivery shaft without altering an axial position of the delivery shaft relative to the prosthetic device.

[0199] Example 30. The method of any example herein, particularly any one of examples 26-29, further comprising radially expanding the prosthetic device to implant the prosthetic device at the target implantation location.

[0200] Example 31. A delivery apparatus for a prosthetic implant, the delivery apparatus comprising: a handle body; a shaft extending distally from the handle body, the shaft having a distal end portion and a proximal end portion; a shaft displacement mechanism coupled to the handle body, the shaft displacement mechanism comprising a slider configured to translate axially relative to the handle body, wherein the proximal end portion of the shaft is coupled to the slider; a shaft adjustment mechanism coupled to the handle body, the adjustment mechanism configured to adjust a curvature of the shaft, the shaft adjustment mechanism comprising a flex element and a pull wire, wherein the flex element is configured to translate axially relative to the slider, wherein the pull wire has a distal end portion and a proximal end portion, wherein the distal end portion of the pull wire is coupled to the distal end portion of the shaft, wherein a proximal end portion of the pull wire is coupled to the flex element; a first actuating mechanism operatively coupled to the shaft displacement mechanism and configured to, upon actuation, simultaneously axially displace the slider and the flex element in a first direction relative to the handle body; and a second actuating mechanism operatively coupled to the shaft adjustment mechanism and configured to, upon actuation, adjust an axial position of the flex element relative to the slider.THVDL-13801W001

[0201] Example 32. The delivery apparatus of any example herein, particularly of Example 31 , further comprising a third actuating mechanism, wherein the third actuating mechanism is operatively coupled to the shaft displacement mechanism and configured to, upon actuation, axially displace the slider in a second direction relative to the handle body, separate from the flex element.

[0202] Example 33. The delivery apparatus of any example herein, particularly any one of examples 31-32, further comprising a third actuating mechanism, wherein the third actuating mechanism is operatively coupled to the shaft displacement mechanism and configured to, upon actuation, axially displace the slider and the flex element in a second direction relative to the handle body.

[0203] Example 34. The delivery apparatus of any example herein, particularly any one of examples 31-33, wherein the first, second, and third actuating mechanisms are separate actuating mechanisms.

[0204] Example 35. The delivery apparatus of any example herein, particularly any one of examples 31-34, wherein the pull wire is biased towards an unflexed state.

[0205] Thus, specific examples of delivery apparatuses and related methods have been disclosed. The above description of the disclosed implementations is provided to enable any person skilled in the art to make or use the delivery apparatuses. The preceding detailed description is merely exemplary in nature and is not intended to limit the delivery apparatuses or the application and uses of the delivery apparatuses. The word “exemplary” is used herein to mean “serving as an example, instance, or illustration.” Any aspect described herein as “exemplary” is not necessarily to be construed as preferred or advantageous over other aspects. Unless specifically stated otherwise, the term “some” refers to one or more. Various modifications to these implementations will be readily apparent to those skilled in the art, and the general principles described herein can be applied to other implementations without departing from the spirit or scope of the application. Thus, it is to be understood that the description and drawings presented herein represent an implementation of the delivery apparatuses and are therefore representative of the subject matter which is broadly contemplated by the present application. It is further understood that the scope of the present application fully encompasses other implementations that may become obvious to those skilled in the art and that the scope of the present application is accordingly not limited.

[0206] The features described herein with regard to any example can be combined with other features described in any one or more of the other examples, unless otherwise stated. For example, any one or more of the features of one shaft adjustment mechanism can beTHVDL-13801W001 combined with any one or more features of another shaft adjustment mechanism. As another example, any one or more features of one delivery apparatus can be combined with any one or more features of another delivery apparatus.

[0207] In view of the many possible ways in which the principles of the disclosure may be applied, it should be recognized that the illustrated configurations depict examples of the disclosed technology and should not be taken as limiting the scope of the disclosure nor the claims. Rather, the scope of the claimed subject matter is defined by the following claims and their equivalents.

[0208] All structural and functional equivalents to the components of the various aspects described throughout this disclosure that are known or later come to be known to those of ordinary skill in the art are expressly incorporated herein by reference and are intended to be encompassed by the claims. Moreover, nothing disclosed herein is intended to be dedicated to the public regardless of whether such disclosure is explicitly recited in the claims.

Claims

THVDL-13801W001CLAIMSWhat is claimed is:

1. A delivery apparatus for a prosthetic implant, the delivery apparatus comprising: a handle body; a shaft extending distally from the handle body, the shaft having a distal end and a proximal end; a shaft displacement mechanism coupled to the handle body, the shaft displacement mechanism comprising a carriage configured to translate axially relative to the handle body, wherein the proximal end of the shaft is coupled to the carriage; a shaft adjustment mechanism coupled to the handle body, the adjustment mechanism configured to adjust a curvature of the shaft, the shaft adjustment mechanism comprising a flex element and a pull wire, wherein the flex element is configured to translate axially relative to the carriage, wherein the pull wire has a distal end and a proximal end, wherein the distal end of the pull wire is coupled to the distal end of the shaft, wherein a proximal end of the pull wire is coupled to the flex element; a first knob operatively coupled to the shaft displacement mechanism and rotatable relative to the handle body, wherein rotating the first knob relative to the handle body simultaneously axially displaces the shaft and the pull wire relative to the handle body; and a second knob operatively coupled to the shaft adjustment mechanism and rotatable relative to the handle body, wherein the second knob is spaced apart from the first knob in the axial direction, wherein rotating the second knob relative to the handle body adjusts the curvature of the shaft independent of an axial displacement of the shaft.

2. The delivery apparatus of claim 1, wherein the shaft displacement mechanism further comprises at least one lead screw operatively coupled to the carriage.

3. The delivery apparatus of either claim 1 or claim 2, wherein the flex element comprises a plate.

4. The delivery apparatus of any one of claims 1-3, wherein the carriage includes a slot, and wherein the flex element is disposed in the slot and configured to translate axially relative to the carriage within the slot.THVDL-13801W0015. The delivery apparatus of any one of claims 1-4, wherein the shaft adjustment mechanism further comprises a flex nut and a flex screw, wherein the flex nut is coupled to the flex screw, wherein rotation of the flex screw drives axial translation of the flex nut.

6. The delivery apparatus of claim 5, wherein the flex nut comprises at least one projection.

7. The delivery apparatus of any one of claims 1 -6, further comprising an indicator disposed on the carriage and operatively coupled to the shaft adjustment mechanism, wherein the indicator is configured to indicate the curvature of the shaft upon rotation of the second knob.

8. The delivery apparatus of any one of claims 1-7, wherein the shaft is configured to encapsulate the prosthetic implant, wherein the prosthetic implant comprises a prosthetic heart valve or a stent.

9. The delivery apparatus of any one of claims 1-8, wherein the prosthetic implant is self-expandable, balloon-expandable, and / or mechanically-expandable.

10. The delivery apparatus of any one of claims 1-9, further comprising an expansion mechanism disposed within the shaft and configured to couple to the prosthetic implant, wherein the expansion mechanism comprises one of: at least one actuator assembly for mechanical expansion of the prosthetic implant and / or an inflatable balloon catheter for balloon expansion of the prosthetic implant.

11. The delivery apparatus of any one of claims 1-10, wherein the carriage comprises one or more of a slider, a block, a sled, or a shuttle.

12. The delivery apparatus of any one of claims 1-11, wherein the flex element comprises one or more of a plate, a rod, or a shaft.

13. The delivery apparatus of any one of claims 1-12, wherein the pull wire comprises one or more of a wire, a suture, a thread, a ribbon, or a cord.THVDL-13801W00114. The delivery apparatus of any one of claims 1-13, wherein one or both of the first knob and the second knob comprises one or more of a dial, a rotary actuator, a control wheel, or an adjustment ring.

15. A delivery apparatus for a prosthetic implant, the delivery apparatus comprising: a handle body; a shaft extending distally from the handle body, the shaft having a distal end and a proximal end; a shaft displacement mechanism coupled to the handle body, the shaft displacement mechanism comprising a carriage configured to translate axially relative to the handle body, wherein the proximal end of the shaft is coupled to the carriage; a shaft adjustment mechanism coupled to the handle body, the adjustment mechanism configured to adjust a curvature of the shaft, the shaft adjustment mechanism comprising a flex nut, a flex plate, and a pull wire having a distal end and a proximal end, wherein the flex nut and the flex plate are configured to translate axially relative to the carriage, wherein the distal end of the pull wire is coupled to the distal end of the shaft, wherein the proximal end of the pull wire is coupled to the flex plate, wherein translation of the flex nut in a proximal direction drives translation of the flex plate in the proximal direction from a first axial position to a second axial position, wherein translation of the flex nut in a distal direction allows the flex plate to remain in the second axial position or return to the first axial position; a first knob operatively coupled to the shaft displacement mechanism and rotatable relative to the handle body, wherein rotating the first knob relative to the handle body simultaneously axially displaces the shaft and the pull wire relative to the handle body; and a second knob operatively coupled to the shaft adjustment mechanism and rotatable relative to the handle body, wherein rotating the second knob relative to the handle body adjusts the curvature of the shaft independent of an axial displacement of the shaft.

16. The delivery apparatus of claim 15, wherein the carriage comprises a slot extending axially along a length of the carriage, wherein the flex plate is disposed within the slot.

17. The delivery apparatus of claim 16, wherein the flex nut comprises at least one projection extending into the slot.THVDL-13801W00118. The delivery apparatus of claim 17, wherein the flex plate comprises a main body and arms extending from the main body, wherein the proximal end of the pull wire is coupled to the main body, and wherein the at least one projection of the flex nut extends between the arms of the flex plate when the flex plate is in the first axial position.

19. The delivery apparatus of either claim 17 or claim 18, wherein the at least one projection contacts the flex plate when the flex nut drives translation of the flex plate from the first axial position to the second axial position.

20. A delivery apparatus for a prosthetic implant, the delivery apparatus comprising: a handle body; a shaft extending distally from the handle body, the shaft having a lumen, a distal end and a proximal end; a shaft displacement mechanism coupled to the handle body, the shaft displacement mechanism comprising a carriage, wherein the proximal end of the shaft is coupled to the carriage; a shaft adjustment mechanism coupled to the handle body, the adjustment mechanism configured to adjust a curvature of the shaft, the shaft adjustment mechanism comprising a flex element configured to translate axially relative to the carriage and a pull wire having a distal end and a proximal end, wherein the distal end of the pull wire is coupled to the distal end of the shaft, wherein a proximal end of the pull wire is coupled to the flex element; a flush rod extending through the carriage, wherein the carriage is configured to translate axially relative to the flush rod between a first axial position relative to the flush rod and a second axial position relative to the flush rod, the flush rod including a flush lumen extending along a length of the flush rod and an opening in fluid communication with the flush lumen, wherein the opening is in fluid communication with the lumen of the shaft when the carriage is in the first axial position and the second axial position; a first knob operatively coupled to the shaft displacement mechanism and rotatable relative to the handle body, wherein rotating the first knob relative to the handle body simultaneously axially displaces the shaft and the pull wire relative to the handle body; andTHVDL-13801W001 a second knob operatively coupled to the shaft adjustment mechanism and rotatable relative to the handle body, wherein rotating the second knob relative to the handle body adjusts the curvature of the shaft independent of an axial displacement of the shaft.

21. The delivery apparatus of claim 20, wherein the opening is spaced apart in the axial direction from a distal end of the flush rod.

22. The delivery apparatus of either claim 20 or claim 21 , further comprising a flush port coupled to the handle body, wherein the flush port is in fluid communication with the flush lumen.

23. The delivery apparatus of any one of claims 20-22, wherein the carriage comprises a chamber, wherein the flush rod extends through the chamber, and further comprising a sheath comprising a plurality of openings disposed within the chamber around the flush rod.

24. The delivery apparatus of any one of claims 20-23, wherein the shaft is configured to encapsulate the prosthetic implant when the carriage is in the first axial position, wherein the prosthetic implant comprises a prosthetic heart valve or a stent.

25. The delivery apparatus of any one of claims 20-24, wherein the prosthetic implant is self-expandable, balloon-expandable, and / or mechanically-expandable.

26. A method of implanting a prosthetic device at a target implantation location within a subject, the method comprising: advancing a delivery shaft of a delivery apparatus through the subject’s vasculature to position the prosthetic device at a target implantation location, wherein the prosthetic device is at least partially received within a distal end portion of the delivery shaft; and retracting the distal end portion of the delivery shaft proximally relative to the prosthetic device, wherein the advancing the delivery shaft through the subject’s vasculature comprises operating a shaft adjustment mechanism to adjust a curvature of the delivery shaft, wherein the retracting the distal end portion of the delivery shaft comprises operating a shaftTHVDL-13801W001 displacement mechanism to move the delivery shaft relative to the prosthetic device without altering the curvature of the delivery shaft.

27. The method of claim 26, wherein the operating the shaft adjustment mechanism comprises actuating a first knob of the delivery apparatus to vary a tension of a pull wire attached to the distal end portion of the delivery shaft, and wherein the operating the shaft displacement mechanism comprises actuating a second knob of the delivery apparatus to axially translate a carriage that is coupled to a proximal end portion of the shaft.

28. The method of claim 27, wherein the operating the shaft displacement mechanism does not alter the tension in the pull wire.

29. The method of any one of claims 26-28, wherein the operating the shaft adjustment mechanism operates to adjust the curvature of the delivery shaft without altering an axial position of the delivery shaft relative to the prosthetic device.

30. The method of any one of claims 26-29, further comprising radially expanding the prosthetic device to implant the prosthetic device at the target implantation location.

31. A delivery apparatus for a prosthetic implant, the delivery apparatus comprising: a handle body; a shaft extending distally from the handle body, the shaft having a distal end portion and a proximal end portion; a shaft displacement mechanism coupled to the handle body, the shaft displacement mechanism comprising a slider configured to translate axially relative to the handle body, wherein the proximal end portion of the shaft is coupled to the slider; a shaft adjustment mechanism coupled to the handle body, the adjustment mechanism configured to adjust a curvature of the shaft, the shaft adjustment mechanism comprising a flex element and a pull wire, wherein the flex element is configured to translate axially relative to the slider, wherein the pull wire has a distal end portion and a proximal end portion, wherein the distal end portion of the pull wire is coupled to the distal end portion of the shaft, wherein a proximal end portion of the pull wire is coupled to the flex element;THVDL-13801W001 a first actuating mechanism operatively coupled to the shaft displacement mechanism and configured to, upon actuation, simultaneously axially displace the slider and the flex element relative to the handle body; and a second actuating mechanism operatively coupled to the shaft adjustment mechanism and configured to, upon actuation, adjust an axial position of the flex element relative to the slider.

Images