Delivery device with robust pull wire anchor

Abstract

A delivery apparatus for implanting a prosthetic heart valve comprises a handle portion, a guide catheter with a selectively steerable section, a pull wire coupled to the steerable section, a puller member to adjust tension in the pull wire and a pull wire anchor received in the puller member and movable axially relative to the puller member. A pull wire proximal end is coupled to the pull wire anchor. A rotatable member is engageable with the puller member to move it and the pull wire anchor proximally relative to the handle portion and, in an opposite direction of rotation, distally relative to the handle portion, with the pull wire anchor free floating relative to the puller member and movable proximally relative to the puller member responsive to tension in the steerable section. Methods of assembling the pull wire and pull wire anchor, such as by welding, are also described.

Description

DELIVERY DEVICE WITH ROBUST PULL WIRE ANCHORCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 584,131 , filed September 20, 2023, which is incorporated by reference herein in its entirety.FIELD

[0002] The present disclosure relates to prosthetic heart valves, including frames for prosthetic heart valves.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 device and advanced through the patient’s vasculature (for example, through a femoral artery and the aorta) until the prosthetic valve reaches the implantation site in the heart. The prosthetic 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 valve, or by deploying the prosthetic valve from a sheath of the delivery apparatus so that the prosthetic valve can self-expand to its functional size.

[0004] A suitable delivery device generally used in a surgical procedure (for example, a catheter) can include one or more pull wires to help steer the device through a patient’ s vasculature. Typically, the delivery device employs a pull wire having a distal end fixedly secured to a steerable section and a proximal end operatively connected to an adjustment mechanism located on a handle of the delivery device outside the patient’s body. The pullwire is typically disposed in a pull- wire lumen that extends longitudinally in or adjacent to a wall of the deliver)' device (for example, a sheath or catheter). Adjusting the adjustment mechanism (for example, rotating a knob), applies a pulling force on the pull wire, which in turn causes the steerable section to bend or curve (that is, to have its radius of curvature reduced).

[0005] A need exists to ensure that the proximal end of the pull wire can be reliably assembled with the adjustment mechanism and maintained securely connected throughout the useful life and full range of functions of the delivery device.SUMMARY

[0006] Described herein are delivery apparatuses for implanting medical devices, such as prosthetic heart valves), and methods for assembling delivery apparatuses. The disclosed delivery apparatuses and methods can, for example, help maintain the pull wire securely connected to the adjustment mechanism.

[0007] In some examples, a delivery apparatus comprises a handle portion, a guide catheter extending distally from the handle portion, the guide catheter comprising a shaft having a selectively steerable section for facilitating advancement through vasculature of a patient and a pull wire coupled to the steerable section and extending proximally to the handle portion, a puller member configured to increase and decrease tension in the pull wire to adjust a radius of curvature of the steerable section, the puller member being positioned within the handle portion and movable axially relative to the handle portion, a pull wire anchor received in the puller member and movable axially relative to the puller member, wherein a proximal end portion of the pull wire is coupled to the pull wire anchor, and a rotatable member positioned on the handle portion and operatively coupled with the puller member such that rotation of the of the rotatable member produces axial movement of the puller member. When the rotatable member is rotated in a first direction to move the puller member proximally relative to the handle portion, the puller member exerts a proximal pulling force on the pull wire anchor to move the pull wire anchor proximally and increase tension on the pull wire, thereby reducing the radius of curvature of the steerable section. When the rotatable member is rotated in a second direction opposite the first direction to move the puller member distallyrelative to the handle portion, the puller member can move distally relative to the pull wire anchor to release the pulling force on the pull wire anchor.

[0008] In some examples, the pull wire anchor comprises a plate-shaped base and the puller member comprises a slot for slidingly receiving the plate-shaped base.

[0009] In some examples, the pull wire is coupled to the pull wire anchor by welding.

[0010] In some examples, the pull wire anchor comprises a groove shaped to receive at least a portion of the pull wire.

[0011] In some examples, the pull wire is welded to the pull wire anchor by laser spot welds that have areas of increasing strength from a distal weld end to a proximal weld end.

[0012] In some examples, the pull wire anchor is welded to the pull wire anchor by laser spot welds arranged in two rows that are angled with respect to each other and increasingly overlap the pull wire moving axially from a distal weld end to a proximal weld end.

[0013] In some examples, the pull wire anchor is welded to the pull wire anchor by laser spot welds applied to a bottom surface of the pull wire anchor opposite the pull wire.

[0014] In some examples, the puller member has projecting bosses and the rotatable member has an internal thread, and wherein the bosses of the puller member are engageable with the internal thread of the rotatable member such that rotation of the rotatable member moves the puller member in translation.

[0015] In some examples, the delivery apparatus further comprises a distal handle positioned to overlie the puller member and underlie the rotatable member, wherein the distal handle comprises slots shaped to permit the bosses of the puller member to project through the distal handle and engage with the internal thread of the rotatable member.

[0016] In some examples, the puller member comprises a protruding bulge, and wherein the distal handle comprises a channel sized to receive the protruding bulge and assist in maintaining angular alignment of the puller member with the distal handle.

[0017] In some examples, the delivery apparatus comprises a spine having a circular crosssection, and wherein the puller member comprises an axial opening sized to slidably receive the circular cross-section of the spine.

[0018] In some examples, a proximal end of the puller member comprises a relieved area adjacent a proximal end.

[0019] In some examples, a delivery apparatus comprises one or more of the components recited in Examples 1-12 below.

[0020] In some examples, a method of assembling a delivery apparatus, the delivery apparatus comprising: a handle portion; a guide catheter connectible to extend distally from the handle portion, the guide catheter comprising a shaft having a selectively steerable section for facilitating advancement through vasculature of a patient and a pull wire coupled to the steerable section and extending proximally to the handle portion; a puller member configured to increase and decrease tension in the pull wire to adjust a radius of curvature of the steerable section; a pull wire anchor positionable in the puller member and movable axially relative to the puller member; and a steering member positioned on the handle portion and operatively coupled to the puller member, and the method comprising welding a proximal end of the pull wire to the pull wire anchor.

[0021] In some examples, the method further comprises, prior to welding, positioning the proximal end of the pull wire in an axial groove of the pull wire anchor.

[0022] In some examples, welding a proximal end of the pull wire to the pull wire anchor comprises creating a weld with multiple overlapping individual welds using a laser welding apparatus.

[0023] In some examples, welding a proximal end of the pull wire to the pull wire anchor comprises forming a weld having increasing strength from a distal weld end to a proximal weld end.

[0024] In some examples, welding a proximal end of the pull wire to the pull wire anchor comprises forming a weld using different weld power settings along a length of the weld from the distal end to the proximal end.

[0025] In some examples, welding a proximal end of the pull wire to the pull wire anchor comprises forming a weld having two rows that are angled with respect to each other.

[0026] In some examples, welding a proximal end of the pull wire to the pull wire anchor comprises forming a weld having increasing overlap with the pull wire and the groove from a distal weld end to a proximal weld end.

[0027] In some examples, welding a proximal end of the pull wire to the pull wire anchor comprises forming a weld by applying the laser welding apparatus to a bottom of the pull wire anchor opposite the axial groove and the pull wire.

[0028] In some examples, a method of assembling a delivery apparatus comprises one or more of the steps recited in Examples 13-20 below.

[0029] In some examples, a delivery apparatus comprises a handle portion, a guide catheter extending distally from the handle portion, the guide catheter comprising a shaft having a selectively steerable section for facilitating advancement through vasculature of a patient and a pull wire coupled to the steerable section and extending proximally to the handle portion, a puller member configured to increase and decrease tension in the pull wire to adjust a radius of curvature of the steerable section, the puller member being positioned within the handle portion and movable axially relative to the handle portion, a pull wire anchor coupled to the puller member, wherein a proximal end portion of the pull wire is welded to the pull wire anchor, and a steering member positioned on the handle portion and operatively coupled to the puller member such that manual adjustment of the steering member produces axial movement of the puller member and adjusts the tension in the pull wire.

[0030] In some examples, the pull wire is welded to the pull wire anchor by laser spot welds that have areas of increasing strength from a distal weld end to a proximal weld end.

[0031] In some examples, the pull wire anchor is welded to the pull wire anchor by laser spot welds arranged in two rows that are angled with respect to each other and increasingly overlap the pull wire moving axially from a distal weld end to a proximal weld end.

[0032] In some examples, the pull wire anchor is welded to the pull wire anchor by laser spot welds applied to a bottom surface of the pull wire anchor opposite the pull wire.

[0033] In some examples, the pull wire anchor comprises a plate-shaped base and the puller member comprises a slot for slidingly receiving the plate-shaped base.

[0034] In some examples, the pull wire anchor is not fixed within the slot.

[0035] In some examples, the pull wire anchor comprises a groove shaped to receive at least a portion of the pull wire.

[0036] In some examples, the steering member comprises a rotatable knob.

[0037] In some examples, a delivery apparatus comprises one or more of the components recited in Examples 22-28 below.

[0038] Any delivery method(s) described herein can be performed on a living animal or on a simulation, such as on a cadaver, cadaver heart, anthropomorphic ghost, simulator (e.g., with body parts, heart, tissue, etc. being simulated).

[0039] 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

[0040] FIG. 1 is a side view of a prosthetic heart valve, according to one example.

[0041] FIG. 2 is a side view of an exemplary delivery apparatus configured to deliver and implant a radially expandable prosthetic heart valve at an implantation site.

[0042] FIG. 3 is a side view of a handle portion of a delivery apparatus according to an example that has a new structure for retaining and manipulating a pull wire.

[0043] FIG. 4 is a side sectional view of the handle portion of the delivery apparatus of FIG. 3.

[0044] FIG. 5 is a perspective view of a sectioned handle portion of the delivery apparatus of FIG. 3 viewed from a different orientation (rotated about the axis 180 degrees) and illustrated with some internal components removed for ease of illustration.

[0045] FIG. 6 is a side view of the sectioned handle portion of FIG. 5 with the additional internal components shown.

[0046] FIG. 7 is a side sectional view a distal handle of the handle portion of FIG. 3 and a puller shown in isolation.

[0047] FIG. 8 is a perspective view of the puller of FIG. 7.

[0048] FIG. 9 is a perspective view of a weld tab according to one example.

[0049] FIGS. 10A-10C are perspective views of the weld tab of FIG. 9 in relation to the puller and the distal handle at different stages of movement of a pull wire coupled to the weld tab.

[0050] FIG. 10D is an end view of the pull tab of FIGS. 10A-10C showing a double pull wire coupled to the weld tab.

[0051] FIGS. 11A-11C are plan views of the weld tab and pull wire coupled together using various welding patterns.

[0052] FIG. 12 is a perspective view of a modified puller with a weld tab and pull wire and mounted to slide with respect to a spine.DETAILED DESCRIPTIONGeneral Considerations

[0053] 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.

[0054] 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 byspecific 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.

[0055] 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.” 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.

[0056] 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 patient’s 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 patient’ s body). The terms “longitudinal” and “axial” refer to an axis extending in the proximal and distal directions, unless otherwise expressly defined.

[0057] As used herein, “e.g.” means “for example,” and “i.e.” means “that is.”Overview of the Disclosed Technology

[0058] 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 other 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., invitro fertilization, artificial insemination), laparoscopic, arthroscopic, transesophageal, transvaginal, transvesical, transrectal, and procedures including access in any body duct or cavity. Some 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.

[0059] As introduced above, a delivery device for a prosthetic valve (or another type of implantable medical device) that uses a pull wire to change the curvature of a steerable section needs to have the proximal end of the pull wire secured to an adjustment mechanism (typically within the handle) in a fashion that can be reliably and repeatedly accomplished by an operator or an automated assembly process. Assembling a delivery device with one or more pull wires can be challenging due at least in part to difficulties in securing the pull wires to the adjustment mechanism for proper functionality. Assembly typically includes a process called wire wrapping, where a proximal end of the pull wire is wrapped around an anchor to secure it to the adjustment mechanism. Wire wrapping typically requires a skilled and well- trained operator to create multiple loops around a small component, such as a piece of metal, to secure the pull wire to the adjustment mechanism. After wire wrapping is completed, the assembly of the pull wires is typically inspected. This inspection may also present challenges because the loops of the pull wire can be difficult to discern when secured to the anchor and it may also be difficult to determine whether the pull wire is sufficiently secured to the anchor.

[0060] Described herein are various examples of a delivery apparatus for a prosthetic valve (or another type of implantable medical device) with a pull wire anchor that is accomplished with high reliability and repeatability, without needing to use the wire wrapping process.

[0061] Prosthetic valves disclosed herein can be radially compressible and expandable between a radially compressed state and a radially expanded state. Thus, the prosthetic valves can be crimped on or retained by an implant delivery apparatus in the radially compressed state while being advanced through a patient’s vasculature on the delivery apparatus. The prosthetic valve can be expanded to the radially expanded state once the prosthetic valve reaches the implantation site. It is understood that the prosthetic valves disclosed herein may be used with a variety of implant delivery apparatuses and can beimplanted via various delivery procedures, examples of which will be discussed in more detail later.Examples of the Disclosed Technology

[0062] FIG. 1 shows a prosthetic heart valve 100 (prosthetic valve), according to one example. Any of the prosthetic valves disclosed herein are adapted to be implanted in the native aortic annulus, although in other 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, arteries and vessels of a patient. 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.

[0063] 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. In another example, 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 another example, 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.

[0064] The prosthetic heart valve 100 can include a stent or frame 102, a valvular structure 104, and a perivalvular outer sealing member or outer skirt 106. The prosthetic heart valve 100 (and the frame 102) can have an inflow end 108 and an outflow end 110. The valvularstructure 104 can be disposed on an interior of the frame 102 while the outer skirt 106 is disposed around an outer surface of the frame 102.

[0065] The valvular structure 104 can comprise a plurality of leaflets 112 (for example, three leaflets, as shown in FIG. 1), collectively forming a leaflet structure, which can be arranged to collapse in a tricuspid arrangement (or bicuspid arrangement in some examples). The leaflets 112 can be secured to one another at their adjacent sides (for example, commissure tabs) to form commissures 114 of the valvular structure 104. For example, each leaflet 112 can comprise opposing commissure tabs disposed on opposite sides of the leaflet 112 and a cusp edge portion extending between the opposing commissure tabs. The cusp edge portion of the leaflets 112 can have an undulating, curved scalloped shape, and can be secured directly to the frame 102 (for example, by sutures). However, in alternate examples, the cusp edge portion of the leaflets 112 can be secured to an inner skirt which is then secured to the frame 102. In some examples, the leaflets 112 can be formed of pericardial tissue (for example, bovine pericardial tissue), biocompatible synthetic materials, or various other suitable natural or synthetic materials as known in the art and described in U.S. Patent No. 6,730,118, which is incorporated by reference herein.

[0066] In some examples, the outer skirt 106 can be an annular skirt. In some instances, the outer skirt 106 can comprise one or more skirt portions that are connected together and / or individually connected to the frame 102. The outer skirt 106 can comprise a fabric or polymeric material, such as ePTFE, PTFE, PET, TPU, UHMWPE, PEEK, PE, etc. In some instances, instead of having a relatively straight upper edge portion, as shown in FIG. 1, the outer skirt 106 can have an undulating upper edge portion that extends along and is secured to the angled struts 134. Examples of such outer skirts, as well as various other outer skirts, that can be used with the frame 102 can be found in U.S. provisional patent application No. 63 / 366,599 filed June 17, 2022, which is incorporated by reference herein.

[0067] The frame 102 can be radially compressible and expandable between a radially compressed (or collapsed) configuration and a radially expanded configuration (the expanded configuration is shown in FIG. 1).

[0068] The frame 102 can be made of any of various suitable plastically-expandable materials (for example, stainless steel, etc.) or self-expanding materials (for example,Nitinol). When constructed of a plastically-expandable material, the frame 102 (and thus the valve 100) can be crimped to a radially compressed state on a delivery catheter and then expanded inside a patient by an inflatable balloon or equivalent expansion mechanism. When constructed of a self-expandable material, the frame 102 (and thus the valve 100) can be crimped to a radially compressed state and restrained in the compressed state by insertion into a sheath or equivalent mechanism of a delivery catheter. Once inside the body, the valve can be advanced from the delivery sheath, which allows the valve to expand to its functional size.

[0069] 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 102 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.

[0070] As shown in FIG. 1, the frame 102 can comprise a plurality of interconnected struts 116 which form multiple rows of open cells 118 between the outflow end 110 and the inflow end 108 of the frame 102. In some examples, the frame 102 can comprise three rows of cells 118 with a first (upper in the orientation shown in FIG. 1) row of cells 120 disposed at the outflow end 110. The first row of cells 120 comprises cells 118 that are elongated in an axial direction (relative to a central longitudinal axis 122 of the frame 102), as compared to cells 118 in the remaining rows of cells. For example, the cells 118 of the first row of cells 120 can have a longer axial length than cells 118 in the remaining rows of cells.

[0071] In some examples, as shown in FIG. 1, each row of cells comprises nine cells 118. Thus, in such examples, the frame 102 can be referred to as a nine-cell frame.

[0072] In alternate examples, the frame 102 can comprise more than three rows of cells (for example, four or five) and / or more or less than nine cells per row. In some examples, thecells 118 in the first row of cells 120 may not be elongated compared to cells 118 in the remaining rows of cells of the frame 102.

[0073] The interconnected struts 116 can include a plurality of angled struts 130 arranged in a plurality of rows of circumferentially extending rows of angled struts, with the rows being arrayed along the length of the frame 102 between the outflow end 1 10 and the inflow end 108. The interconnected struts 116 can also include a plurality of axially extending window struts 138 (or window strut portions) and a plurality of axial (or axially extending) struts 140. The axially extending window struts 138 (which can also be referred to as axial struts that include a commissure window) define commissure windows (for example, open windows) 142 that are spaced apart from one another around the frame 102, in a circumferential direction, and which are adapted to receive a pair of commissure tabs of a pair of adjacent leaflets 112 arranged into a commissure (for example, commissure 114). In some examples, the commissure windows 142 and / or the axially extending window struts 138 defining the commissure windows 142 can be referred to herein as commissure features or commissure supports, each commissure feature or support configured to receive and / or be secured to a pair of commissure tabs of a pair of adjacent leaflets.

[0074] One or more (for example, two, as shown in FIG. 1) axial struts 140 can be positioned between, in the circumferential direction, two commissure windows 142 formed by the window struts 138. Since the frame 102 can include fewer cells per row (for example, nine) and fewer axial struts 140 between each commissure window 142, as compared to some more traditional prosthetic heart valves, each cell 118 can have an increased width (in the circumferential direction), thereby providing a larger opening for blood flow and / or coronary access.

[0075] Each axial strut 140 and each window strut 138 forms an axial side of two adjacent cells of the first row of cells 120.

[0076] Commissure tabs 115 of adjacent leaflets 112 can be secured together to form commissures 114 (FIG. 1). Each commissure 114 of the prosthetic heart valve 100 comprises two commissure tabs 115 paired together, one from each of two adjacent leaflets 112, and extending through a commissure window 142 of the frame 102. Each commissure 114 can be secured to the window struts 138 forming the commissure window 142.

[0077] The cusp edge portion (for example, scallop edge) of each leaflet 112 can be secured to the frame 102 via one or more fasteners (for example, sutures). In some examples, the cusp edge portion of each leaflet 112 can be secured directly to the struts of the frame 102.

[0078] In some examples, the cusp edge portion of the leaflets 112 can be secured to an inner skirt and the inner skirt can then be secured directly to the frame 102.

[0079] Various methods for securing the leaflets 112 to a frame, such as the frame 102, are disclosed in U.S. provisional patent applications 63 / 278,922, filed November 12, 2021, and 63 / 300,302, filed January 18, 2022, both of which are incorporated by reference herein.

[0080] The frame 102 can further comprise a plurality of apex regions 152 formed at the inflow end 108 and the outflow end 110, each apex region 152 extending and forming a junction between two angled struts 130 at the inflow end 108 or outflow end 110. As such, the apex regions 152 are spaced apart from one another, in a circumferential direction at the inflow end 108 and the outflow end 110. Additional details and examples of frames for prosthetic heart valves that include apex regions can be found in PCT Application No. PCT / US2022 / 025687, which is incorporated by reference herein.

[0081] FIG. 2 shows a delivery apparatus 200, according to an example, that can be used to implant an expandable prosthetic heart valve (for example, the prosthetic heart valve 100 of FIG. 1 and / or any of the other prosthetic heart valves described herein). In some examples, the delivery apparatus 200 is specifically adapted for use in introducing a prosthetic valve into a heart.

[0082] The delivery apparatus 200 in the illustrated example of FIG. 2 is a balloon catheter comprising a handle 202 and a steerable, outer shaft 204 extending distally from the handle 202. The delivery apparatus 200 can further comprise an intermediate shaft 206 (which also may be referred to as a balloon shaft) that extends proximally from the handle 202 and distally from the handle 202, the portion extending distally from the handle 202 also extending coaxially through the outer shaft 204. Additionally, the delivery apparatus 200 can further comprise an inner shaft 208 extending distally from the handle 202 coaxially through the intermediate shaft 206 and the outer shaft 204 and proximally from the handle 202 coaxially through the intermediate shaft 206.

[0083] The outer shaft 204 and the intermediate shaft 206 can be configured to translate (for example, move) longitudinally, along a central longitudinal axis 220 of the delivery apparatus 200, relative to one another to facilitate delivery and positioning of a prosthetic valve at an implantation site in a patient’s body.

[0084] The intermediate shaft 206 can include a proximal end portion 210 that extends proximally from a proximal end of the handle 202, to an adaptor 212. A rotatable knob 214 can be mounted on the proximal end portion 210 and can be configured to rotate the intermediate shaft 206 around the central longitudinal axis 220 and relative to the outer shaft 204.

[0085] The adaptor 212 can include a first port 238 configured to receive a guide wire therethrough and a second port 240 configured to receive fluid (for example, inflation fluid) from a fluid source. The second port 240 can be fluidly coupled to an inner lumen of the intermediate shaft 206.

[0086] The intermediate shaft 206 can further include a distal end portion that extends distally beyond a distal end of the outer shaft 204 when a distal end of the outer shaft 204 is positioned away from an inflatable balloon 218 of the delivery apparatus 200. A distal end portion of the inner shaft 208 can extend distally beyond the distal end portion of the intermediate shaft 206.

[0087] The balloon 218 can be coupled to the distal end portion of the intermediate shaft 206.

[0088] In some examples, a distal end of the balloon 218 can be coupled to a distal end of the delivery apparatus 200, such as to a nose cone 222 (as shown in FIG. 2), or to an alternate component at the distal end of the delivery apparatus 200 (for example, a distal shoulder).An intermediate portion of the balloon 218 can overlay a valve mounting portion 224 of a distal end portion of the delivery apparatus 200 and a distal end portion of the balloon 218 can overlay a distal shoulder 226 of the delivery apparatus 200. The valve mounting portion 224 and the intermediate portion of the balloon 218 can be configured to receive a prosthetic heart valve in a radially compressed state. For example, as shown schematically in FIG. 2, a prosthetic heart valve 250 (which can be one of the prosthetic valves described herein) can bemounted around the balloon 218, at the valve mounting portion 224 of the delivery apparatus 200.

[0089] The balloon shoulder assembly, including the distal shoulder 226, is configured to maintain the prosthetic heart valve 250 (or other medical device) at a fixed position on the balloon 218 during delivery through the patient’s vasculature.

[0090] The outer shaft 204 can include a distal tip portion 228 mounted on its distal end. The outer shaft 204 and the intermediate shaft 206 can be translated axially relative to one another to position the distal tip portion 228 adjacent to a proximal end of the valve mounting portion 224, when the prosthetic valve 250 is mounted in the radially compressed state on the valve mounting portion 224 (as shown in FIG. 2) and during delivery of the prosthetic valve to the target implantation site. As such, the distal tip portion 228 can be configured to resist movement of the prosthetic valve 250 relative to the balloon 218 proximally, in the axial direction, relative to the balloon 218, when the distal tip portion 228 is arranged adjacent to a proximal side of the valve mounting portion 224.

[0091] An annular space can be defined between an outer surface of the inner shaft 208 and an inner surface of the intermediate shaft 206 and can be configured to receive fluid from a fluid source via the second port 240 of the adaptor 212. The annular space can be fluidly coupled to a fluid passageway formed between the outer surface of the distal end portion of the inner shaft 208 and an inner surface of the balloon 218. As such, fluid from the fluid source can flow to the fluid passageway from the annular space to inflate the balloon 218 and radially expand and deploy the prosthetic valve 250.

[0092] An inner lumen of the inner shaft can be configured to receive a guidewire therethrough, for navigating the distal end portion of the delivery apparatus 200 to the target implantation site.

[0093] The handle 202 can include a steering mechanism configured to adjust the curvature of the distal end portion of the delivery apparatus 200 (also referred to herein as the steerable section). In the illustrated example, for example, the handle 202 includes an adjustment member, such as the illustrated rotatable knob 260, which in turn is operatively coupled to the proximal end portion of a pull wire. The pull wire can extend distally from the handle 202 through the outer shaft 204 and has a distal end portion affixed to the outer shaft 204 at ornear the distal end of the outer shaft 204 (also referred to herein as the steerable section). Rotating the knob 260 can increase or decrease the tension in the pull wire, thereby adjusting the curvature of the distal end portion of the delivery apparatus 200 (steerable section). Further details on steering or flex mechanisms for the delivery apparatus can be found in U.S. Patent No. 9,339,384, which is incorporated by reference herein.

[0094] The handle 202 can further include an adjustment mechanism 261 including an adjustment member, such as the illustrated rotatable knob 262, and an associated locking mechanism including another adjustment member, configured as a rotatable knob 278. The adjustment mechanism 261 is configured to adjust the axial position of the intermediate shaft 206 relative to the outer shaft 204 (for example, for fine positioning at the implantation site). Further details on the delivery apparatus 200 can be found in PCT Application No. PCT / US2021 / 047056, which is incorporated by reference herein.

[0095] As introduced above, satisfactorily anchoring the pull wire for a steerable section of a delivery device can present challenges. Examples of such a delivery device include those shown in U.S. Pub. No. 2016 / 0158497, which is incorporated by reference herein in its entirety. Such a delivery device can be used where it is beneficial or advantageous to steer the device during a procedure. The one or more pull wires are typically secured to a distal end of the delivery device (the steerable section of a shaft) and to an adjustment or steering mechanism at a proximal end. Manipulating the adjustment mechanism allows an operator to steer the delivery device increasing or decreasing tension on the pull wire, which in turn causes the steerable section to bend or to straighten. Assembling a catheter or other delivery device with one or more pull wires can be challenging due at least in part to difficulties in securing the pull wires to the adjustment mechanism for proper functionality. Assembly typically includes a process called wire wrapping, in which a proximal end of the pull wire is wrapped around an anchor to secure it to the adjustment mechanism. Another similar process involves crimping the pull wire to a post or other member of the adjustment mechanism.Wire wrapping typically requires a skilled and well-trained operator to create multiple loops around a small component, such as a piece of metal, to secure the wire to the adjustment mechanism. After wire wrapping is completed, the assembly of the pull wires is typically inspected. This inspection may also present challenges because the loops of the wire can bedifficult to discern when secured to the anchor and it may also be difficult to determine whether the wire is sufficiently secured to the anchor.

[0096] Described herein are various examples of a pull wire anchor with which the proximal end of the pull wire can be reliably secured to the adjustment mechanism in a repeatable way. For example, the pull wire can be secured without requiring wire wrapping, which means a less skilled operator can complete the operations of assembling the pull wire with the adjustment mechanism. In some examples, the pull wire is secured to the adjustment mechanism without requiring wiring wrapping in a way that is easier to accomplish and easier to inspect. In some examples, the proximal end of the pull wire is attached to a platelike pull wire anchor that can slide within a centrally located axial slot in a puller member. In some examples, the proximal end of the pull wire is welded to the pull wire anchor. In some examples, the pull wire anchor has an axial groove shaped to receive at least a portion of proximal end of the pull wire. In some examples, the pull wire is coupled to the pull wire anchor by welding, and the strength of the weld is selectively varied in the axial direction.

[0097] A delivery device 300 having a new pull wire anchor is shown in FIGS. 3-7 and 10A- 10C. For purposes of illustration, the delivery device 300 as illustrated in FIGS. 3-5 is shown with a guide catheter 310 having a guide catheter sheath or shaft 312 extending distally from a handle portion 320. The shaft 312 has a steerable section 313 along a distal end portion thereof. The curvature of the shaft 312 can be adjusted by varying the tension of a pull wire 360 extending through the shaft 312, as further described below. A strain relief nose 314 can surround the shaft 312 at the distal end of the handle portion 320. In the illustrated example, the handle portion 320 comprises a pair of mating handle grips 322 having scalloped surfaces for the user’s fingers. There is a distal handle portion 326 that forms a distal end of the handle portion 320 and has a distal handle shaft 332 that extends proximally, as best shown in FIGS. 4-7. An adjustment device or steering member in the form of a rotatable member or knob 324 is positioned proximally of and overlies the distal handle portion 326, as best shown in FIGS. 4 and 6. A flush fluid port 330 of an adaptor is shown protruding from the handle near the proximal end of the handle portion 320.

[0098] Referring again to FIG. 4, the rotatable member 324 has an exposed portion which can have an optional over-molded surface 325 and a proximally extending portion that is enclosed by the handle grips 322. The handle grips 322 and similar mating portions of thedistal handle portion 326 can be secured together, such as at locations 342, for example, with fasteners.

[0099] The rotatable member 324 is rotatable relative to the distal handle portion 326, which is stationary. The rotatable member 324 has an internal thread 340, which can extend axially along its length as shown. FIGS. 5, 6 and 7 are similar to FIG. 4, but show internal views of an opposite side of the delivery apparatus 300 and at a different angle of rotation about the axis. In FIG. 5, the rotatable member 324 is removed to permit illustration of other internal components. For example, as best shown in FIGS. 5, 6 and 7, there is a puller 346 (also referred to herein as a pull member or puller member) having a pull wire 360 engaged therewith that is axially translatable relative to the rotatable member 324 (and the other stationary components of the handle portion 320) as the rotatable member 324 is rotated. The puller 346 can have two or more projecting bosses 350 (see also FIG. 8) or other structure(s) shaped to engage the internal thread 340 of the rotatable member 324. In the illustrated implementation, the bosses 350 are arranged generally opposite each other, with one of the bosses being slightly more proximal and the other of the bosses being slightly more distal. In the illustrated implementation, the puller 346 slidingly translates along a separate component, referred to as a spine 344, while the bosses 350 extend radially through respective slots 334 in the distal handle portion 326 and engage in the internal thread 340, as best shown in FIGS. 5-7. In use, the puller 346 is restricted from rotation by the sliding engagement between the bosses 350 and the slots 334. The spine 344 fits over the shaft 312.

[0100] A perspective view of the puller 346 is shown in FIG. 8. In use, the puller 346 pulls the pull wire 360 because it is anchored to the puller 346, at least in the pulling direction (that is, the proximal direction), as is described in greater detail below. Referring to FIGS. 5 and 8, the puller has a pull wire anchor 356 received therein, such as in a slot 362 (recess) extending axially and formed in an outer surface thereof. The slot 362 has an open side facing a proximal end 366 of the puller 546. A pull wire opening 364 can extend from the slot 362 distally to a distal end 368 of the puller 346 to allow routing the pull wire 360 to extend distally along the sleeve 344 as shown in FIG. 5.

[0101] Referring to FIG. 9, the pull wire anchor 356 can be plate-shaped as shown, and can be sized to translate or “float” relative to the slot 362 formed in the puller 346 when tension on the pull wire is decreased. The pull wire anchor 356 can have a groove, slot or otherrecess, such an axially extending groove 358, shaped to receive at least a portion of the pull wire 360. The pull wire 360 can be coupled to the pull wire anchor 356 in a secure fashion, such as, for example, by welding, adhesion, a forming operation, etc. Additional details about coupling the pull wire 360 to the pull wire anchor 35 are described below in greater detail.

[0102] In addition to the bosses 350 / slots 334, the puller 346 can have additional alignment features. For example, referring to FIG. 8, the puller 346 can have a bulge 352 that protrudes radially beyond the radius of the remaining circular cross-section of the puller 346. The bulge 352, which is hidden from view in FIG. 7, can be sized to fit within an axial channel 336 on an inner side of the distal handle 326 as shown. The sliding engagement between the bulge 352 and the channel 336 further assists in maintaining the puller 346 in alignment and keeping it from rotating as the rotary member 324 is moved in both directions to change the tension in the pull wire 360.

[0103] As shown in FIG. 8, the puller 346 can have a relieved area 370 adjacent the proximal end 366.

[0104] The pull wire 360 extends from the pull wire anchor 356, through the opening 364 in the puller 346, through an opening in the sleeve (not shown), and into and through a pull wire lumen in the shaft 312 (not shown), with the distal end portion of the pull wire 360 being secured to the steerable section 313. For example, the distal end portion of the pull wire 360 can be secured to a pull wire ring embedded within the steerable section 313 of the shaft 312.

[0105] The relative motion of the pull wire anchor and the pull wire relative to the motion of the puller are also described in FIGS. 10A-10D. In the example of FIGS. 10-10D, the pull wire is a double pull wire 361 . As best shown in FIG. 10D, which is an end view of the pull wire anchor 356, the slot 362 can be sized to accommodate the two strands of the double pull wire 361. The double pull wire can comprise two separate wires that extend side-by-side from the anchor 356 through the shaft 312 to the pull wire ring (or another fixation component) secured to the steerable section of the shaft 312. Alternatively, the double pull wire can comprise a single wire formed into a loop having two side-by-side wire strands that extend from the anchor 356 through the shaft 312 to the pull wire ring (or another fixation component).

[0106] The pull wire anchor 356, which retains the proximal end of the pull wire 360, is captured in the slot 362 in the puller 346. In FIG. 10A, the puller 346 is shown in its most distal position with one of the bosses 350 abutting a distal end of the slot 334, and the pull wire anchor 356 is positioned to abut a distal end of the slot 362. In this position, there can be little or no tension in the pull wire 360 and the steerable section 313 of the shaft 312 can be in a non-deflected state (for example, the curvature of the steerable section is not affected by the pull wire). In FIG. 10B, the rotatable member 324 has been rotated to move the puller 346 proximally from its position in FIG. 10 A, which in turn has moved (pulled) the pull wire 361 in the proximal direction, increasing tension in the pull wire. The movement of the pull wire 361 pulls the distal end of the steerable section 313 back toward the handle portion 320, thereby bending the steerable section and reducing its radius of curvature. The friction between the rotatable member 324 and the puller 346 is sufficient to hold the pull wire 361 taut, thus preserving the shape of the bend in the steerable section if the operator releases the rotatable member 324.

[0107] In FIG. 10C, the rotatable member 324 has been rotated in the opposite direction, which has moved the puller 346 in the distal direction. As the puller 346 is moved distally, the proximal pulling force exerted on the pull wire is released. . The resiliency of the steerable section 313 urges the steerable section to return its normal, non-deflected shape as tension on the pull wire 361 is decreased. If the delivery apparatus extends through a relatively non-tortuous section of the patient’s vasculature, movement of the puller 346 in the distal direction along with the resiliency of the steerable section allows the pull wire to move distally and tension on the pull wire is decreased or completely removed. On the other hand, if the delivery apparatus extends through a tortuous section of the patient’ s vasculature, the curvature of the steerable section may be retained after the puller 346 is moved to the distal position. If the curvature is severe, releasing the proximal pulling force from the pull wire may not allow the pull wire to slide distally to its initial, non- tensioned state of FIG. 10A and the pull wire and anchor can remain in the tensioned state, as depicted in FIG. 10C. Because the pull wire 361 and anchor 356 are not fixed to the puller 346, movement of the puller 346 in the distal direction does not push on the end of the pull wire 361, which could cause it to buckle . Instead, the pull wire anchor 356 is allowed to “free float” (that, is slide) within the slot 362, remaining substantially stationary as the puller 346 is moved proximally, whenthe rotatable member 324 is rotated to remove the pulling force from the pull wire 361. Consequently, as the shaft 312 of the delivery apparatus is withdrawn from the patient’s vasculature, the steerable section 313 can return to its non-deflected state, which in turn causes the pull wire 361 and the anchor 356 to slide distally within the slot 362 of the puller, back to the distal, non-tension position of the pull wire (FIG. 10A).

[0108] In some examples, the steerable section 313 in its non-deflected shape is slightly curved and in its fully curved position, the steerable section 313 generally conforms to the shape of the aortic arch. In other examples, the steerable section can be substantially straight in its non-deflected position.

[0109] As described above, the pull wire can be coupled to the pull wire anchor in various ways that provide a sufficiently secure connection to ensure that the pull wire does not become detached from the pull wire anchor during use, as well as to facilitate assembly in a manner that does not require inordinate skill and can be readily inspected. In the examples of FIGS. 11A-11C, the pull wire 360 is positioned within the groove 358 and coupled to the pull wire anchor 356 by welding. Welding can be accomplished with less skill than other techniques, including, for example, wire wrapping. Welding the pull wire 360 to the anchor 356 can be accomplished very quickly compared to the time-consuming process of wire wrapping. Moreover, welding can be used to secure pull wires that have cross-sections of any shape (circular, rectangular, square, dual wires, etc.), whereas a wire wrapping technique can only be used to secure pull wires that have a single circular cross-section. Thus, in the disclosed examples, the pull wires 360, 361 can have any of various cross-sectional profiles (taken in a plane perpendicular to the length of the wire), including circular (as shown in FIG. 10D), square, rectangular, etc.

[0110] The welding can be accomplished, for example, by positioning the puller 346 with the pull wire anchor 356 received in the slot 362 (or the pull wire anchor 356 alone) in a fixture (not shown), inserting an end of the pull wire 360 into the groove 358, and laser welding the pull wire 360 and the pull wire anchor 356 together.

[0111] For example, as shown in FIG. 11 A, a weld 390a can be generated from overlapping individual welds applied in two rows over the two sides of the groove 358, with the pull wire 360 received therein, for a predetermined axial distance. In some implementations, thestrength of the weld 390a can be varied, such as varying the strength of the of the individual welds to increase from a distal end to a proximal end. As one example, the weld 390a could be formed using low power on a welding apparatus for a first third of the length of the weld 390a, medium power for a second third of the length and high power for the final third of the length.

[0112] As another example, a weld 390b as shown in FIG. 1 IB can be generated from two rows of overlapping individual welds that are angled relative to each other by an angle a so that welds at the distal end overlap less of the pull wire 360 / groove 358 (weaker) and welds at the proximal end overlap more of the pull wire 360 / groove 358 (stronger). The weld 390b can be formed by using a constant weld power and achieve a bond that increases in strength from the distal end to the proximal end.

[0113] As yet another example, a weld 390c as shown in FIG. 11C can be generated by applying the welding apparatus to the bottom of the pull wire anchor 354 opposite the pull wire 360 / groove 358. In this way, the pull wire 360 is partially shielded from the full strength of the welding apparatus by the thickness of the pull wire anchor 354 adjacent the groove 358. This welding approach can help protect against undesirably hardening (annealing) the wire through applying excessive heating.

[0114] In some implementations, the groove 358 is sized very slightly larger in width than the size of the pull wire with which it will be used. For example, for a pull wire having a diameter of 0.012 inch, the groove can be 0.013 in wide and 0.007 inch deep. In this way, the tangent edges of a circular wire are just within the depth of the groove 358, whereas a portion of the wire protrudes from the groove, such as is shown in FIG. 10D. In other examples, the pull wire can be completely recessed within the groove 358 or flush with the upper surface of the anchor 356.

[0115] FIG. 12 is an illustration of a puller 380 according to another example. The puller 380 is similar to the puller 346 as described above in many respects, but does not have the relief 370 at the proximal end.

[0116] In some examples, the delivery apparatus 300 can have any of the features of the delivery apparatus 200. For example, the delivery apparatus 300 can have a balloon shaft 206 and an inflatable balloon 218 for implanting a balloon-expandable prosthetic heart valve(for example, prosthetic valve 100). In some examples, the delivery apparatus 300 can be adapted to implant a self-expandable prosthetic heart valve. For example, the delivery apparatus 300 can include an additional shaft extending from the handle 320 (such as coaxially through the shaft 312), wherein the distal end portion of the additional shaft comprises or is attached to a delivery capsule that retains the self-expandable prosthetic valve in a radially compressed state until the prosthetic valve is released from the delivery capsule.

[0117] In some examples, the delivery apparatus 300 can comprise a steerable introducer that can be used with a separate implant catheter to implant a medical device. For example, during an implant procedure, the shaft 312 can be inserted into a blood vessel of a patient, such as a femoral vein or femoral artery. A separate implant catheter that includes a prosthetic valve (such as crimped on a balloon or retained within a capsule of the implant catheter) can be inserted distally through the handle 320 via a proximal opening 331 in the handle (FIG. 4) and distally through the first port in the adaptor and the shaft 312. The implant catheter is advanced distally until the implant is advanced distally beyond the shaft 312 and is located at the desired implantation site. The handle 320 may include one or more hemostatic seals 333 at a proximal end of the adaptor that can form a fluid-tight seal around the shaft of the implant catheter that extends through the handle 320.Delivery Techniques

[0118] For implanting a prosthetic valve within the native aortic valve via a transfemoral 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 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 (for example, 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).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.Alternatively, in a transaortic procedure, a prosthetic valve (on the distal end portion of thedelivery apparatus) is introduced into the aorta through a surgical incision in the ascending aorta, such as through a partial J-sternotomy or right parasternal mini-thoracotomy, and then advanced through the ascending aorta toward the native aortic valve.

[0119] 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. 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.

[0120] 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.

[0121] 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 chest 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.

[0122] In all delivery approaches, the delivery apparatus can be advanced over a guidewire previously inserted into a patient’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 delivery procedures and delivery devices known in the art. Also, any of the delivery techniques described above can be used to deliver a docking component for a prosthetic valve, using the same delivery device or a separate delivery device.Sterilization

[0123] 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 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 for use in sterilization include, without limitation, gamma radiation, ultra-violet radiation, and electron beam. Examples of chemicals 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.Simulation

[0124] The treatment techniques, methods, steps, etc. described or suggested herein or in references incorporated herein can be performed on a living animal or on a non-living simulation, such as on a cadaver, cadaver heart, anthropomorphic ghost, simulator (for example, with the body parts, tissue, etc. being simulated), etc.Additional Examples of the Disclosed Technology

[0125] 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.

[0126] Example 1. A delivery apparatus, comprising: a handle portion;a guide catheter extending distally from the handle portion, the guide catheter comprising a shaft having a selectively steerable section for facilitating advancement through vasculature of a patient and a pull wire coupled to the steerable section and extending proximally to the handle portion; a puller member configured to increase and decrease tension in the pull wire to adjust a radius of curvature of the steerable section, the puller member being positioned within the handle portion and movable axially relative to the handle portion; a pull wire anchor received in the puller member and movable axially relative to the puller member, wherein a proximal end portion of the pull wire is coupled to the pull wire anchor; and a rotatable member positioned on the handle portion and operatively coupled to the puller member such that rotation of the rotatable member produces axial movement of the puller member, wherein when the rotatable member is rotated in a first direction to move the puller member proximally relative to the handle portion, the puller member exerts a proximal pulling force on the pull wire anchor to move the pull wire anchor proximally and increase tension on the pull wire, thereby reducing the radius of curvature of the steerable section, and wherein when the rotatable member is rotated in a second direction opposite the first direction to move the puller member distally relative to the handle portion, the puller member can move distally relative to the pull wire anchor to release the pulling force on the pull wire anchor.

[0127] Example 2. The delivery apparatus of any example herein, particularly Example 1, wherein the pull wire anchor comprises a plate-shaped base and the puller member comprises a slot for slidingly receiving the plate-shaped base.

[0128] Example 3. The delivery apparatus of any example herein, particularly Examples 1-2, wherein the pull wire is coupled to the pull wire anchor by welding.

[0129] Example 4. The delivery apparatus of any example herein, particularly Examples 1-3, wherein the pull wire anchor comprises a slot shaped to receive at least a portion of the pull wire.

[0130] Example 5. The delivery apparatus of any example herein, particularly Examples 1-4, wherein the pull wire is welded to the pull wire anchor by laser spot welds that have areas of increasing strength from a distal weld end to a proximal weld end.

[0131] Example 6. The delivery apparatus of any example herein, particularly Examples 1-5, wherein the pull wire anchor is welded to the pull wire anchor by laser spot welds arranged in two rows that are angled with respect to each other and increasingly overlap the pull wire moving axially from a distal weld end to a proximal weld end.

[0132] Example 7. The delivery apparatus of any example herein, particularly Examples 1-6, wherein the pull wire anchor is welded to the pull wire anchor by laser spot welds applied to a bottom surface of the pull wire anchor opposite the pull wire.

[0133] Example 8. The delivery apparatus of any example herein, particularly Examples 1-7, wherein the puller member has projecting bosses and the rotatable member has an internal thread, and wherein the bosses of the puller member are engageable with the internal thread of the rotatable member such that rotation of the rotatable member moves the puller member in translation.

[0134] Example 9. The delivery apparatus of any example herein, particularly Example 8, further comprising a distal handle positioned to overlie the puller member and underlie the rotatable member, wherein the distal handle comprises slots shaped to permit the bosses of the puller member to project through the distal handle and engage with the internal thread of the rotatable member.

[0135] Example 10. The delivery apparatus of any example herein, particularly Example 9, wherein the puller member comprises a protruding bulge, and wherein the distal handle comprises a channel sized to receive the protruding bulge and assist in maintaining angular alignment of the puller member with the distal handle.

[0136] Example 11. The delivery apparatus of any example herein, particularly Examples 1- 10, wherein the delivery apparatus comprises a spine having a circular cross-section, and wherein the puller member comprises an axial opening sized to slidably receive the circular cross-section of the spine.

[0137] Example 12. The delivery apparatus of any example herein, particularly Examples 1-11, wherein a proximal end of the puller member comprises a relieved area adjacent a proximal end.

[0138] Example 13. A method of assembling a delivery, the delivery apparatus comprising a handle portion; a guide catheter connectible to extend distally from the handle portion, the guide catheter comprising a shaft having a selectively steerable section for facilitating advancement through vasculature of a patient and a pull wire coupled to the steerable section and extending proximally to the handle portion; a puller member configured to increase and decrease tension in the pull wire to adjust a radius of curvature of the steerable section; a pull wire anchor positionable in the puller member and movable axially relative to the puller member; and a steering member positioned on the handle portion and operatively coupled to the puller member, the method comprising: welding a proximal end of the pull wire to the pull wire anchor.

[0139] Example 14. The method of any example herein, particularly Example 13, further comprising, prior to welding, positioning the proximal end of the pull wire in an axial groove of the pull wire anchor.

[0140] Example 15. The method of any example herein, particularly Examples 13-14, wherein welding a proximal end of the pull wire to the pull wire anchor comprises creating a weld with multiple overlapping individual welds using a laser welding apparatus.

[0141] Example 16. The method of any example herein, particularly Examples 13-15, wherein welding a proximal end of the pull wire to the pull wire anchor comprises forming a weld having increasing strength from a distal weld end to a proximal weld end.

[0142] Example 17. The method of any example herein, particularly Examples 13-16, wherein welding a proximal end of the pull wire to the pull wire anchor comprises forming aweld using different weld power settings along a length of the weld from the distal end to the proximal end.

[0143] Example 18. The method of any example herein, particularly Examples 13-17, wherein welding a proximal end of the pull wire to the pull wire anchor comprises forming a weld having two rows that are angled with respect to each other.

[0144] Example 19. The method of any example herein, particularly Examples 14-18, wherein welding a proximal end of the pull wire to the pull wire anchor comprises forming a weld having increasing overlap with the pull wire and the groove from a distal weld end to a proximal weld end.

[0145] Example 20. The method of any example herein, particularly Examples 14-18, wherein welding a proximal end of the pull wire to the pull wire anchor comprises forming a weld by applying the laser welding apparatus to a bottom of the pull wire anchor opposite the axial groove and the pull wire.

[0146] Example 21. A delivery apparatus comprising: a handle portion; a guide catheter extending distally from the handle portion, the guide catheter comprising a shaft having a selectively steerable section for facilitating advancement through vasculature of a patient and a pull wire coupled to the steerable section and extending proximally to the handle portion; a puller member configured to increase and decrease tension in the pull wire to adjust a radius of curvature of the steerable section, the puller member being positioned within the handle portion and movable axially relative to the handle portion; a pull wire anchor coupled to the puller member, wherein a proximal end portion of the pull wire is welded to the pull wire anchor; and a steering member positioned on the handle portion and operatively coupled to the puller member such that manual adjustment of the steering member produces axial movement of the puller member and adjusts the tension in the pull wire.

[0147] Example 22. The delivery apparatus of any example herein, particularly Example 21, wherein the pull wire is welded to the pull wire anchor by laser spot welds that have areas of increasing strength from a distal weld end to a proximal weld end.

[0148] Example 23. The delivery apparatus of any example herein, particularly Examples 21 -22, wherein the pull wire anchor is welded to the pull wire anchor by laser spot welds arranged in two rows that are angled with respect to each other and increasingly overlap the pull wire moving axially from a distal weld end to a proximal weld end.

[0149] Example 24. The delivery apparatus of any example herein, particularly Examples 21-23, wherein the pull wire anchor is welded to the pull wire anchor by laser spot welds applied to a bottom surface of the pull wire anchor opposite the pull wire.

[0150] Example 25. The delivery apparatus of any example herein, particularly Examples 21-24, wherein the pull wire anchor comprises a plate-shaped base and the puller member comprises a slot for slidingly receiving the plate-shaped base.

[0151] Example 26. The delivery apparatus of any example herein, particularly Example 25, wherein the pull wire anchor is not fixed within the slot.

[0152] Example 27. The delivery apparatus of any example herein, particularly Examples 21-26, wherein the pull wire anchor comprises a groove shaped to receive at least a portion of the pull wire.

[0153] Example 28. The delivery apparatus of any example herein, particularly Examples 21-27, wherein the steering member comprises a rotatable knob.

[0154] 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 features of one device can be combined with any one or more features of another device.

[0155] In view of the many possible ways in which the principles of the disclosure may be applied, it should be recognized that the illustrations depict examples of the disclosed technology and should not be taken as limiting the scope of the disclosure or the claims. Rather, the scope of the claimed subject matter is defined by the following claims and their equivalents.

Claims

We claim:

1. A delivery apparatus, comprising: a handle portion; a guide catheter extending distally from the handle portion, the guide catheter comprising a shaft having a selectively steerable section for facilitating advancement through vasculature of a patient and a pull wire coupled to the steerable section and extending proximally to the handle portion; a puller member configured to increase and decrease tension in the pull wire to adjust a radius of curvature of the steerable section, the pull member being positioned within the handle portion and movable axially relative to the handle portion; a pull wire anchor received in the puller member and movable axially relative to the puller member, wherein a proximal end portion of the pull wire is coupled to the pull wire anchor; and a rotatable member positioned on the handle portion and operatively coupled to the puller member such that rotation of the rotatable member produces axial movement of the puller member, wherein when the rotatable member is rotated in a first direction to move the puller member proximally relative to the handle portion, the puller member exerts a proximal pulling force on the pull wire anchor to move the pull wire anchor proximally and increase tension on the pull wire, thereby reducing the radius of curvature of the steerable section, and wherein when the rotatable member is rotated in a second direction opposite the first direction to move the puller member distally relative to the handle portion, the puller member can move distally relative to the pull wire anchor to release the pulling force on the pull wire anchor.

2. The delivery apparatus of claim 1, wherein the pull wire anchor comprises a plate-shaped base and the puller member comprises a slot for slidingly receiving the plateshaped base.

3. The delivery apparatus of any of claims 1-2, wherein the pull wire is coupled to the pull wire anchor by welding.

4. The delivery apparatus of any of claims 1-2, wherein the pull wire anchor comprises a groove shaped to receive at least a portion of the pull wire.

5. The delivery apparatus of any of claims 1-2, wherein the pull wire is welded to the pull wire anchor by laser spot welds that have areas of increasing strength from a distal weld end to a proximal weld end.

6. The delivery apparatus of any of claims 1-2, wherein the pull wire anchor is welded to the pull wire anchor by laser spot welds arranged in two rows that are angled with respect to each other and increasingly overlap the pull wire moving axially from a distal weld end to a proximal weld end.

7. The delivery apparatus of any of claims 1-2, wherein the pull wire anchor is welded to the pull wire anchor by laser spot welds applied to a bottom surface of the pull wire anchor opposite the pull wire.

8. The delivery apparatus of any of claims 1-2, wherein the puller member has projecting bosses and the rotatable member has an internal thread, and wherein the bosses of the puller member are engageable with the internal thread of the rotatable member such that rotation of the rotatable member moves the puller member in translation.

9. The delivery apparatus of claim 8, further comprising a distal handle positioned to overlie the puller member and underlie the rotatable member, wherein the distal handle comprises slots shaped to permit the bosses of the puller member to project through the distal handle and engage with the internal thread of the rotatable member.

10. The delivery apparatus of claim 9, wherein the puller member comprises a protruding bulge, and wherein the distal handle comprises a channel sized to receive theprotruding bulge and assist in maintaining angular alignment of the puller member with the distal handle.

11. The delivery apparatus of any of claims 9-10, wherein the delivery apparatus comprises a spine having a circular cross-section, and wherein the puller member comprises an axial opening sized to slidably receive the circular cross-section of the spine.

12. A method of assembling a delivery apparatus, the delivery apparatus comprising: a handle portion; a guide catheter connectible to extend distally from the handle portion, the guide catheter comprising a shaft having a selectively steerable section for facilitating advancement through vasculature of a patient and a pull wire coupled to the steerable section and extending proximally to the handle portion; a puller member configured to increase and decrease tension in the pull wire to adjust a radius of curvature of the steerable section; a pull wire anchor positionable in the puller member and movable axially relative to the puller member; and a steering member positioned on the handle portion and operatively coupled to the puller member, the method comprising: welding a proximal end of the pull wire to the pull wire anchor.

13. The method of claim 12, further comprising, prior to welding, positioning the proximal end of the pull wire in a groove of the pull wire anchor.

14. The method of any of claims 12-13, wherein welding a proximal end of the pull wire to the pull wire anchor comprises creating a weld with multiple overlapping individual welds using a laser welding apparatus.

15. The method of any of claims 12-13, wherein welding a proximal end of the pull wire to the pull wire anchor comprises forming a weld having increasing strength from a distal weld end to a proximal weld end.

16. The method of any of claims 12-13, wherein welding a proximal end of the pull wire to the pull wire anchor comprises forming a weld using different weld power settings along a length of the weld from a distal weld end to a proximal weld end.

17. A delivery apparatus comprising: a handle portion; a guide catheter extending distally from the handle portion, the guide catheter comprising a shaft having a selectively steerable section for facilitating advancement through vasculature of a patient and a pull wire coupled to the steerable section and extending proximally to the handle portion; a puller member configured to increase and decrease tension in the pull wire to adjust a radius of curvature of the steerable section, the puller member being positioned within the handle portion and movable axially relative to the handle portion; a pull wire anchor coupled to the puller member, wherein a proximal end portion of the pull wire is welded to the pull wire anchor; and a steering member positioned on the handle portion and operatively coupled to the puller member such that manual adjustment of the steering member produces axial movement of the puller member and adjusts the tension in the pull wire.

18. The delivery apparatus of claim 17, wherein the pull wire anchor comprises a plate-shaped base and the puller member comprises a slot for slidingly receiving the plateshaped base.

19. The delivery apparatus of claim 17, wherein the pull wire anchor is not fixed within the slot.

20. The delivery apparatus of any of claims 17-19, wherein the pull wire anchor comprises a groove shaped to receive at least a portion of the pull wire.

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