Delivery apparatus for a prosthetic valve

Abstract

Delivery apparatuses including torqueable shafts configured to transfer torque to an inflatable balloon of the delivery apparatus are disclosed. A delivery apparatus for a prosthetic device can comprise a handle, a rotatable first shaft extending distally from the handle, a second shaft extending distally from the handle and through the first shaft and having a distal end portion extending distally beyond a distal end of the first shaft, an inflatable balloon arranged around the distal end portion of the second shaft, a crimp balloon extending from the first shaft to the inflatable balloon, the crimp balloon disposed around the second shaft, and a third shaft extending distally from the handle and through the first shaft and around the second shaft. The third shaft is configured to extend through the crimp balloon and receive a prosthetic valve in a radially compressed configuration.

Description

DELIVERY APPARATUS FOR A PROSTHETIC VALVECROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Patent Application No.63 / 730,410, filed December 10, 2024, which is incorporated by reference herein in its entirety.FIELD

[0002] The present disclosure relates to delivery apparatuses for delivering and deploying prosthetic heart valves, and in particular to rotatable or torqueable shafts for the delivery apparatuses.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 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.SUMMARY

[0004] In some examples, it may be desirable to rotate the prosthetic valve on the delivery apparatus, prior to implantation, to achieve a desired rotational or circumferential alignment of the prosthetic valve relative to the native anatomy. However, it may be difficult to effectively transmit torque to the distal end portion of the delivery apparatus where theprosthetic valve is mounted. Accordingly, a need exists for improved delivery apparatuses that can effectively rotate the prosthetic valve mounted thereon prior to deployment and implantation.

[0005] Described herein are examples of systems and methods for delivering and implanting a prosthetic valve at a native valve of a heart of a subject (e.g., a living subject, a simulation). In some examples, the prosthetic valve can be mounted in a radially compressed state onto a delivery apparatus for delivery to a target implantation site and then deployed at the target implantation site (for example, the native valve) with the delivery apparatus. The delivery apparatus can include an inflatable balloon and the prosthetic valve can be radially expanded and deployed by inflating the balloon at the target implantation site. In some examples, for delivery through a subject’s vasculature toward an implantation, the prosthetic valve is mounted off the inflatable balloon and then moved axially onto the balloon prior to deployment.

[0006] The delivery apparatus can include a crimp balloon that is configured to receive the prosthetic valve thereon during delivery through the subject’s vasculature, and which extends between the inflatable balloon and a rotatable shaft (for example, a rotatable balloon shaft) of the delivery apparatus.

[0007] In some examples, the delivery apparatus can include a torqueable shaft that extends through an outer shaft of the delivery apparatus and around an inner shaft of the delivery apparatus to which the inflatable balloon is mounted. The torqueable shaft is configured to extend underneath the crimp balloon and effectively transfer torque along its length to a proximal end portion of the inflatable balloon.

[0008] In some examples, the torqueable shaft is coupled to the proximal end portion of the inflatable balloon or a distal tip of the delivery apparatus.

[0009] In some examples, the torqueable shaft is movable between a retracted position inside the outer shaft and away from the crimp balloon to an advanced position where it extends underneath the crimp balloon to or toward the proximal end portion of the inflatable balloon.

[0010] In some examples, the delivery apparatus can include a rotatable monoshaft comprising multiple lumens and a smaller diameter shaft portion that extends to a distal end of the delivery apparatus and is configured to transfer torque along its length.

[0011] In some examples, the delivery apparatus can include a rotatable shaft that includes a flex tip at its distal end that is configured to selectively clamp onto the proximal end portion of the inflatable balloon.

[0012] In some examples, the delivery apparatus can include a rotatable distal tip (or flex tip) at a distal end of an outer shaft of the delivery apparatus that is freely rotatable relative to a remainder (or shaft portion) of the outer shaft.

[0013] In some examples, the rotatable distal tip can be configured to mate with and rotate a prosthetic valve mounted around the inflatable balloon of the delivery apparatus.

[0014] As a result, torque can be effectively transferred to an inflatable balloon of the delivery apparatus and allow for rotation of the prosthetic valve, when mounted both on the inflatable balloon and off the inflatable balloon (for example, on a crimp balloon adjacent to the inflatable balloon).

[0015] A delivery apparatus for a prosthetic implant can comprise one or more shafts.

[0016] In some examples, the one or more shafts can be coupled to and extend distally from a handle of the delivery apparatus.

[0017] In some examples, the one or more shafts includes a rotatable first shaft.

[0018] In some examples, the one or more shafts includes a second shaft extending through the first shaft and having a distal end portion extending distally beyond a distal end of the first shaft.

[0019] In some examples, the delivery apparatus includes an inflatable balloon arranged around the distal end portion of the second shaft.

[0020] In some examples, the delivery apparatus includes a crimp balloon extending from the first shaft to the inflatable balloon, the crimp balloon at least partially disposed around the second shaft.

[0021] In some examples, the delivery apparatus includes a crimp balloon extending between the first shaft and the inflatable balloon, the crimp balloon at least partially disposed around the second shaft.

[0022] In some examples, the delivery apparatus includes an outer flex shaft that is axially movable relative to the first shaft and the second shaft, and is configured to bend around a central longitudinal axis of the delivery apparatus.

[0023] In some examples, the delivery apparatus includes a rotatable third shaft extending through the first shaft and around the second shaft, where the third shaft is configured toextend underneath the crimp balloon and receive a prosthetic valve in a radially compressed configuration.

[0024] In some examples, the third shaft extends distally from the handle of the delivery apparatus to either a proximal end portion of the inflatable balloon or a distal tip of the delivery apparatus.

[0025] In some examples, the third shaft comprises a dense array of metal wire.

[0026] In some examples, the third shaft is a metal hypotube.

[0027] In some examples, the third shaft is translatable, in a direction of a central longitudinal axis of the delivery apparatus, relative to the first shaft and the second shaft such that the third shaft is movable between a first position where it is disposed inside the first shaft and away from the crimp balloon and second position where it extends underneath the crimp balloon toward the inflatable balloon.

[0028] In some examples, the first shaft has a distal tip comprising a plurality of fingers that are configured to selectively engage a proximal end portion of the inflatable balloon.

[0029] In some examples, the distal tip is movable between a first position where the plurality of fingers is spaced radially away from the second shaft and a proximal leg of the inflatable balloon and a second position where the plurality of fingers is arranged against and lock onto the proximal leg of the inflatable balloon.

[0030] In some examples, the delivery apparatus comprises a rotatable shaft comprising a main section with a first lumen and a second lumen that are fluidly separated and radially offset from one another inside the main section and an extension section (or extension portion) extending from a distal end of the main section to a distal tip of the delivery apparatus, where the second lumen further extends through the extension section.

[0031] In some examples, the main section extends distally from the handle.

[0032] In some examples, the one or more shafts comprises an outer shaft comprising a shaft portion and a distal tip that is configured to rotate.

[0033] In some examples, the distal tip is freely rotatable relative to the shaft portion.

[0034] In some examples, the distal tip is a flex tip that is flexible and configured to compress and expand in a radial direction.

[0035] In some examples, the delivery apparatus includes a balloon shaft and an inner shaft that extend through the outer shaft, and wherein the balloon shaft and the outer shaft are axially movable relative to one another.

[0036] In some examples, a delivery apparatus for a prosthetic device comprises a handle; a rotatable first shaft extending distally from the handle; a second shaft extending distally from the handle and through the first shaft and having a distal end portion extending distally beyond a distal end of the first shaft; an inflatable balloon arranged around the distal end portion of the second shaft; a crimp balloon extending from the first shaft to the inflatable balloon, the crimp balloon disposed around the second shaft; and a rotatable third shaft extending distally from the handle and through the first shaft and around the second shaft. The third shaft is configured to extend through the crimp balloon and receive a prosthetic valve in a radially compressed configuration.

[0037] In some examples, a delivery apparatus for a prosthetic device comprises a first shaft; a shaft assembly extending through the first shaft and having a distal end portion extending distally beyond a distal end of the first shaft, where the shaft assembly is rotatable relative to the first shaft and comprises a second shaft defining a lumen configured to receive a guidewire; and a third shaft that is configured to transfer torque along its length. The third shaft surrounds the second shaft. The delivery apparatus further comprises an inflatable balloon arranged around the distal end portion of the shaft assembly. The third shaft extends to at least a proximal end portion of the inflatable balloon. The delivery apparatus further comprises a crimp balloon extending around an outer surface of the third shaft and coupled to a proximal end of the inflatable balloon.

[0038] In some examples, a delivery apparatus for a prosthetic device comprises a rotatable first shaft; a second shaft extending through the first shaft and having a distal end portion extending distally beyond a distal end of the first shaft; an inflatable balloon arranged around the distal end portion of the second shaft; a crimp balloon extending from the first shaft to the inflatable balloon, the crimp balloon disposed around the second shaft; and a rotatable third shaft extending through the first shaft and around the second shaft. The third shaft is translatable, in a direction of a central longitudinal axis of the delivery apparatus, relative to the first shaft and second shaft such that the third shaft is movable between a first position where it is disposed inside the first shaft and away from the crimp balloon and second position where it extends through the crimp balloon toward the inflatable balloon.

[0039] In some examples, a delivery apparatus for a prosthetic device comprises a rotatable shaft comprising a main section having a first diameter; an extension portion extending from a distal end of the main section and having a second diameter that is smaller than the firstdiameter; a first lumen extending through the main section, with an opening of the first lumen defined in the distal end of the main section; and a second lumen extending through the main section and the extension portion. The second lumen is radially offset from the first lumen and configured to receive a guidewire. The delivery apparatus further comprises an inflatable balloon arranged around the extension portion. A proximal end portion of the inflatable balloon is bonded to the distal end of the main section such that the first lumen is fluidly coupled with an interior of the inflatable balloon.

[0040] In some examples, a delivery apparatus for a prosthetic device comprises a handle; a distal tip; a rotatable shaft comprising a main section with a first lumen and a second lumen that are fluidly separated and radially offset from one another inside the main section, where the main section extends distally from the handle; and an extension portion extending from a distal end of the main section to the distal tip. The second lumen further extends through the extension portion. The delivery apparatus further comprises an inflatable balloon arranged around the extension portion. A proximal end portion of the inflatable balloon is bonded to the distal end of the main section such that the first lumen is fluidly coupled with an interior of the inflatable balloon.

[0041] In some examples, a delivery apparatus for a prosthetic device comprises a first shaft that is rotatable and has a distal tip comprising a plurality of fingers; a second shaft extending through the first shaft and having a distal end portion extending distally beyond a distal end of the first shaft; and an inflatable balloon arranged around the distal end portion of the second shaft. The distal tip is movable between a first position where the plurality of fingers is spaced radially away from the second shaft and a proximal leg of the inflatable balloon and a second position where the plurality of fingers is arranged against and lock onto the proximal leg of the inflatable balloon.

[0042] In some examples, a delivery apparatus for a prosthetic device comprises a first shaft comprising a shaft portion and a distal tip that is coupled to a distal end of the shaft portion such that it is freely rotatable relative to the shaft portion; a second shaft extending through the first shaft and having a distal end portion extending distally beyond a distal end of the first shaft; and an inflatable balloon arranged around the distal end portion of the second shaft.

[0043] In some examples, a delivery apparatus comprises one or more of the components recited in Examples 1-16, 20-35, 39-49, 57-66, 70-80, 82-92, 101-112, and 112-129 below.

[0044] An assembly can comprise a prosthetic heart valve and a delivery apparatus.

[0045] In some examples, the prosthetic valve is mounted in a radially collapsed configuration around a crimp balloon and a shaft of the delivery apparatus that is arranged within the crimp balloon.

[0046] In some examples, an assembly comprises one or more of the components recited in Examples 17-19, 36-38, 67-69, 81, 93, and 113-115 below.

[0047] A method can comprise moving, in an axial direction, a radially collapsed prosthetic valve from a position around a crimp balloon of a delivery apparatus to a position around an inflatable body of an inflatable balloon of the delivery apparatus.

[0048] In some examples, the method can comprise rotating the first shaft to rotate the inflatable balloon and the prosthetic valve mounted thereon.

[0049] In some examples, a method comprises advancing a distal end portion of a rotatable, first shaft of a delivery apparatus from a first position within a rotatable, second shaft of the delivery apparatus to a second position where the distal end portion of the first shaft extends underneath a crimp balloon of the delivery apparatus. The crimp balloon is coupled between a distal end of the first shaft and an inflatable balloon of the delivery apparatus. The method further comprises, after the first shaft is in the second position, rotating the first shaft and the second shaft to rotate a prosthetic valve mounted on a distal end portion of the delivery apparatus in a radially compressed configuration.

[0050] In some examples, a method comprises moving a distal tip of a rotatable first shaft from a first position where the distal tip is disengaged from a proximal end portion of an inflatable balloon of a delivery apparatus, to a second position where the distal tip is engaged with the proximal end portion of the inflatable balloon, or an extension shaft directly connected to the proximal end portion of the inflatable balloon, where the inflatable balloon is mounted around a distal end portion of a second shaft that extends through the first shaft and has a distal end portion extending distally beyond a distal end of the first shaft; and rotating the first shaft, while the distal tip is in the second position, and transferring the rotation to the inflatable balloon such that a prosthetic valve mounted on the inflatable balloon rotates.

[0051] In some examples, a method comprises moving, in an axial direction, a radially collapsed prosthetic valve from a position around a crimp balloon of a delivery apparatus to a position around an inflatable body of an inflatable balloon of the delivery apparatus. Thecrimp balloon extends between a rotatable, first shaft of the delivery apparatus and the inflatable balloon, and the first shaft extends through a second shaft of the delivery apparatus. The first and second shafts are translatable in the axial direction relative to one another, and the second shaft comprises a shaft portion and a distal tip coupled to a distal end of the shaft portion, where the distal tip is in contact with the prosthetic when the prosthetic valve is moved onto the inflatable balloon. The method further comprises rotating the first shaft to rotate the inflatable balloon and the prosthetic valve mounted thereon; and during the rotating, freely rotating the distal tip relative to the shaft portion of the second shaft.

[0052] In some examples, a method comprises one or more of the features recited in Examples 50-56, 94-100, and 116-120 below.

[0053] The above method(s), techniques, processes, operations, steps, etc. described or suggested herein or in the references incorporated herein, and any methods of using the systems, assemblies, apparatuses, devices, etc. herein, can be performed on a living subject (e.g., human, or other animal) or on a simulation, such as on a cadaver, cadaver heart, anthropomorphic ghost, or simulator (for example, with body parts, heart, tissue, etc. being simulated), etc. When performed on a simulation, the body parts, e.g., heart, tissue, valve, etc., can be assumed to be simulated or can optionally be referred to as “simulated” (e.g., simulated heart, simulated tissue, simulated valve, etc.) and can optionally comprise computerized and / or physical representations of body parts, tissue, etc. The term “simulation” covers use on a cadaver, computer simulator, imaginary person (e.g., if they are just demonstrating in the air on an imaginary heart), etc.

[0054] 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

[0055] FIG. 1 is a perspective view of a prosthetic heart valve, according to an example.

[0056] FIG. 2 is a side view of a delivery apparatus for implanting a prosthetic heart valve, according to an example.

[0057] FIG. 3 A is a cross-sectional view of the handle of the delivery apparatus of FIG. 2.

[0058] FIG. 3B is another cross-sectional view of the handle of the delivery apparatus of FIG. 2.

[0059] FIG. 4 is side view of a section of the handle and a section of the distal end portion of the delivery apparatus of FIG. 2.

[0060] FIG. 5A is a side view of the distal end portion of the delivery apparatus of FIG. 2.

[0061] FIG. 5B is a cross-sectional side view of the distal end portion of the delivery apparatus of FIG. 2.

[0062] FIG. 6 is a cross-sectional side view of a distal end portion of a delivery apparatus including an inner shaft assembly comprising an innermost, first shaft defining a lumen configured to receive a guidewire, and a second shaft that surrounds the first shaft and is configured to transfer torque along its length.

[0063] FIG. 7A is a schematic, cross-sectional view of the distal end portion of the delivery apparatus of FIG. 6, where the second shaft of the inner shaft assembly extends to a proximal end portion (or proximal leg) of the inflatable balloon.

[0064] FIG. 7B is a schematic, cross-sectional view of the distal end portion of the delivery apparatus of FIG. 6, where the second shaft of the inner shaft assembly extends to a distal tip of the delivery apparatus.

[0065] FIG. 8 is a perspective view of an exemplary portion of the second shaft comprising multiple (for example, two) layers of coiled wire.

[0066] FIG. 9 is a perspective view of an exemplary portion of the second shaft comprising a single layer of coiled wire.

[0067] FIG. 10A is a detailed side view of a bond between a distal end of the second shaft of FIG. 7A and a proximal leg of the inflatable balloon 328.

[0068] FIG. 10B is an exemplary attachment interface between the distal end of the second shaft and the proximal leg of the inflatable balloon of FIG. 10 A.

[0069] FIG. 11 A is a perspective view of a distal end portion of a delivery apparatus including an advanceable torque shaft that is movable relative to an inner shaft and a balloon shaft of the delivery apparatus, wherein the advanceable torque shaft extends through the balloon shaft and surrounds the inner shaft.

[0070] FIG. 1 IB is a perspective view of an example of the distal end of the advanceable shaft of FIG. 11 A, where the distal end has a mating feature, shaped like a gear or cog withprotrusions, that is configured to mate with a complementary mating feature on the proximal end portion of the inflatable balloon.

[0071] FIG. 11C is a perspective view of an example of the distal end of the advanceable shaft of FIG. 11 A, where the distal end has a mating feature, shaped as a triangle, that is configured to mate with a complementary mating feature on the proximal end portion of the inflatable balloon.

[0072] FIG. 12A is a schematic showing the advanceable torque shaft of FIG. 11 A in a first position where it is retracted away from the crimp balloon within the balloon shaft.

[0073] FIG. 12B is a schematic showing the advanceable torque shaft of FIG. 11 A in a second position where it is advanced underneath the crimp balloon toward the proximal end portion of the inflatable balloon.

[0074] FIG. 13A is a side view of a proximal end portion of the delivery apparatus of FIG. 11 A, wherein a proximal end of the advanceable torque shaft is attached to an activating member positioned proximal to a handle of the delivery apparatus.

[0075] FIG. 13B is a side view of a proximal end portion of the delivery apparatus of FIG. 11 A, wherein a proximal end of the advanceable torque shaft is attached to an activating member positioned within a handle of the delivery apparatus.

[0076] FIG. 14 is a perspective view of a rotatable shaft for a delivery apparatus that comprises a main section with a first lumen and a second lumen that are fluidly separated and radially offset from one another inside the main section and an extension section extending from a distal end of the main section, where the second lumen further extends through the extension section.

[0077] FIG. 15 is a cross-sectional end view of the main section of the rotatable shaft of FIG.14.

[0078] FIG. 16 is a perspective view of a portion of the rotatable shaft of FIG. 14, depicting an interface where the extension section extends distally from the distal end of the main section.

[0079] FIG. 17A is a perspective view of a distal end portion of a delivery apparatus including the rotatable shaft of FIG. 14, where the extension section of the rotatable shaft extends underneath the inflatable balloon to a distal tip of the delivery apparatus.

[0080] FIG. 17B is a perspective view of a distal end portion of a delivery apparatus including the rotatable shaft of FIG. 14, where the extension section of the rotatable shaft extends underneath the inflatable balloon to a distal tip of the delivery apparatus.

[0081] FIG. 18A is a cross-sectional side view of a distal end portion of a delivery apparatus including a rotatable shaft with a flex tip at its distal end, the flex tip including a plurality of flexible fingers that are in a first position where the fingers are spaced radially away from the crimp balloon and a proximal leg of the inflatable balloon of the delivery apparatus.

[0082] FIG. 18B is a cross-sectional side view of the distal end portion of the delivery apparatus of FIG. 18A where the flexible fingers of the flex tip are in a second position where the plurality of flexible fingers are arranged against and locked onto the proximal leg of the inflatable balloon by a pull ring advanced over the fingers.

[0083] FIG. 19A is a cross-sectional side view of a distal end portion of a delivery apparatus including a rotatable shaft with a flex tip at its distal end, the flex tip including a plurality of flexible fingers that are in a first position where the fingers are spaced radially away from the crimp balloon and a proximal leg of the inflatable balloon of the delivery apparatus.

[0084] FIG. 19B is a cross-sectional side view of the distal end portion of the delivery apparatus of FIG. 19A where the flexible fingers of the flex tip are in a second position where the plurality of flexible fingers are arranged against and locked onto the proximal leg of the inflatable balloon by a shaft arranged around the fingers.

[0085] FIG. 20 is a cross-sectional side view of a distal end portion of a delivery apparatus include a rotatable distal tip arranged at a distal end of an outer shaft of the delivery apparatus.

[0086] FIG. 21 is a side view of a portion of the distal end portion of the delivery apparatus of FIG. 20, where the distal tip comprises mating features configured to interface with a prosthetic device mounted around an inflatable balloon of the delivery apparatus.DETAILED DESCRIPTIONGeneral Considerations

[0087] 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. Themethods, 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.

[0088] 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.

[0089] 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.

[0090] 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 (forexample, 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.

[0091] 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.

[0092] 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 temr “some” refers to one or more.

[0093] It will be understood that the benefits and advantages described above can relate to one implementation or can relate to several implementations. Aspects described in connection with one implementation are intended to be able to be used with the other implementation. Any explanation in connection with one implementation applies to similar features of the other implementations, and elements of multiple implementations can be combined to form other implementations. The implementations are not limited to those that solve any or all of the stated problems or those that have any or all of the stated benefits and advantages.

[0094] As used herein, “e.g.” means “for example,” and “i.e.” means “that is.”Overview of the Disclosed Technology

[0095] 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.

[0096] As introduced above, it may be desirable to rotate a prosthetic valve (or other prosthetic device) mounted on a delivery apparatus in a radially compressed configuration. For example, prior to implantation, rotating the prosthetic valve with the delivery apparatus can allow for commissures of the prosthetic valve to be rotationally aligned with commissures of the native valve, thereby improving the performance of the implanted prosthetic heart valve, improving the function of the native anatomy, and / or enabling future interventional procedures that require access to coronary arteries or the valve leaflet.

[0097] In some examples, for delivery of the prosthetic valve to a target implantation site, the prosthetic valve can be initially radially compressed and mounted at a location that is axially offset from the central section of the inflatable balloon, such as around a crimp balloon or relatively thin piece of tubing that connects a distal end of the balloon shaft of the delivery apparatus to a proximal end of the inflatable balloon. The crimp balloon gives the prosthetic valve a smaller-diameter inner member to mount onto, thereby reducing the overall crimp profile of the prosthetic valve and push forces and making it easier to navigate the prosthetic valve through a patient’s vasculature using the delivery apparatus. However, due to the crimp balloon being relatively thin and flimsy, rotation of the balloon shaft can result in unwanted twisting or deformation of the crimp balloon / tubing underneath the valve. This can cause unwanted movements of the prosthetic valve and / or twisting of other portions of the delivery apparatus.

[0098] Thus, in some examples, a more rigid shaft of the delivery apparatus can extend to a proximal end of the inflatable balloon and be configured to receive a prosthetic valve radially compressed thereon and transfer torque to the inflatable balloon. In some examples, the more rigid shaft extends from a handle of the delivery apparatus to the proximal end of the inflatable balloon or to a distal shoulder or tip of the delivery apparatus.

[0099] In some examples, the shaft of the delivery apparatus can be axially translatable toward and away from the proximal end portion of the inflatable balloon. As such, the shaft can be advanceable to selectively transfer torque along its length to the inflatable balloon.

[0100] In some examples, the shaft of the delivery apparatus can include a flex tip at its distal end that is configured to selectively clamp onto the proximal end portion of the inflatable balloon.

[0101] In some examples, the shaft of the delivery apparatus can be a rotatable monoshaft comprising multiple lumens and a smaller diameter shaft portion that extends to a distal end of the delivery apparatus and is configured to transfer torque along its length.

[0102] FIG. 1 is an exemplary prosthetic valve that can be mounted on and delivered by a delivery apparatus, such as the delivery apparatus shown in FIGS. 2-5B. In some examples, the delivery apparatus comprises a crimp balloon that extends between a distal end of a balloon shaft of the delivery apparatus and a proximal end of the inflatable balloon of the delivery apparatus (as shown in FIG. 5B). The crimp balloon can be configured to receive a prosthetic valve radially compressed thereon, as shown in FIG. 5A.

[0103] FIGS. 6-10B depict examples of a torqueable shaft for a delivery apparatus. For example, the torqueable shaft can extend from a handle of the delivery apparatus to at least a proximal end portion of the inflatable balloon and be configured to receive a prosthetic valve in a radially compressed configuration. In some examples, the torqueable shaft comprises one or more layers of a coiled wire, which can provide it with enhanced torque transmission along its length.

[0104] FIGS. 11 A-13B depict examples of a translatable (or “advanceable”) shaft for a delivery apparatus that is movable between a first position where it is disposed inside an outer shaft of the delivery apparatus and away from the crimp balloon and second position where it extends underneath the crimp balloon toward the inflatable balloon. An inner shaft of the delivery apparatus can extend through the translatable shaft to a distal end of the delivery apparatus.

[0105] FIGS. 14-17 depict examples of a rotatable shaft for a delivery apparatus that comprises a main section with a first lumen and a second lumen that are fluidly separated and radially offset from one another inside the main section, where the main section extends distally from the handle of the delivery apparatus, and an extension section (or extension portion) extending from a distal end of the main section to a distal tip of the delivery apparatus, where the second lumen further extends through the extension section. The extension section of the rotatable shaft can extend underneath the inflatable balloon and be configured to receive a prosthetic valve in a radially compressed configuration. The rotatable shaft is configured such that it transfers torque along its length, thereby effectively rotating the prosthetic valve mounted thereon.

[0106] FIGS. 18A-19B depict examples of a rotatable shaft for a delivery apparatus that has a flex tip at its distal end, the flex tip including a plurality of flexible fingers that are movable between a first position where the plurality of flexible fingers are spaced radially away from the crimp balloon and a proximal leg of the inflatable balloon and a second position where the plurality of flexible fingers are arranged against and lock onto the proximal leg of the inflatable balloon. In the second position, the rotatable shaft effectively transfers torque to the inflatable balloon and allows rotation of the prosthetic valve.

[0107] FIGS. 20 and 21 depict examples of a rotatable distal tip at a distal end of an outer shaft of a delivery apparatus. In some examples, the distal tip is a flex tip that is freely rotatable relative to a remainder of the outer shaft. In some examples, the distal tip is a flex tip that defines a distal end of the outer shaft, and the distal tip is rotatable via rotation of the outer shaft. In some examples, the distal tip comprises mating features configured to interface with a prosthetic device mounted around the inflatable balloon of the delivery apparatus. The distal tip can be configured to transfer torque directly to the prosthetic valve and / or freely rotate during rotation of the inflatable balloon so that torque does not build up at the distal tip.Examples of the Disclosed Technology

[0108] 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.

[0109] 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 pulmonaryvalve, 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.

[0110] 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 valvular structure 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.

[0111] 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 (for example, by sutures) to an inner skirt 124 which is then secured to the frame 102 (such as with sutures 126).

[0112] In some examples, the cusp edge portion of the leaflets 112 can be secured directly to the frame 102 (for example, by sutures).

[0113] 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.

[0114] In some examples, each of the outer skirt 106 and the inner skirt 124 can be an annular skirt. In some instances, the outer skirt 106 and / or the inner skirt 124 can comprise one or more skirt portions that are connected together and / or individually connected to theframe 102. The skirts 106, 124 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 PCT Publication No. WO / 2023 / 244612, which is incorporated by reference herein.

[0115] 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).

[0116] 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.

[0117] 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 -cobaltchromium. 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.

[0118] 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 inflowend 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.

[0119] 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.

[0120] 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, the cells 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.

[0121] 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 110 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.

[0122] 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 thecircumferential direction), thereby providing a larger opening for blood flow and / or coronary access.

[0123] Each axial strut 140 and each window strut 138 forms an axial side of two adjacent cells of the first row of cells 120.

[0124] 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.

[0125] 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.

[0126] 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.

[0127] Various methods for securing the leaflets 112 to a frame, such as the frame 102, are disclosed in PCT Publication No. WO 2023 / 086548, which is incorporated by reference herein.

[0128] 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.

[0129] FIGS. 2-5B show 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). In some examples, the delivery apparatus 200 is specifically adapted for use in introducing a prosthetic valve into a heart.

[0130] The delivery apparatus 200 generally includes a steerable guide catheter 214, and a balloon catheter 216 extending through the guide catheter 214. The guide catheter 214 can also be referred to as a flex catheter or a main catheter. The use of the term “main catheter”should be understood, however, to include flex or guide catheters, as well as other catheters or shafts that do not have the ability to flex or guide through a subject’s vasculature.

[0131] The guide catheter 214 and the balloon catheter 216 in the illustrated example are adapted to slide longitudinally relative to each other to facilitate delivery and positioning of a prosthetic valve 212 (which may be the prosthetic valve 100 of FIG. 1, in some examples) at an implantation site in a subject’s body, as described further below.

[0132] The guide catheter 214 includes a handle portion 220 (as shown in FIGS. 2-3B) and an elongated guide tube, or shaft, 222 extending from handle portion 220 (FIG. 3A, 4, 5A, and 5B). FIG. 2 shows the delivery apparatus without the guide catheter shaft 222 (which can also be referred to herein as the “outer shaft 222”) for purposes of illustration. FIG. 4 shows the guide catheter shaft 222 extending from the handle portion 220 over the balloon catheter. The balloon catheter 216 includes a proximal portion 224 (FIG. 2) adjacent the handle portion 220 and an elongated shaft 226 (referred to herein as the balloon catheter shaft or balloon shaft) that extends from the proximal portion 224 and through handle portion 220 and guide catheter shaft 222 (FIGS. 2, and 4-5B).

[0133] The handle portion 220 can include a side arm 227 having an internal passage which fluidly communicates with a lumen defined by the handle portion 220.

[0134] An inflatable balloon 228 is mounted at the distal end of balloon catheter 216. As shown in FIG. 5A, the delivery apparatus 200 is configured to mount the prosthetic valve 212 in a crimped (radially compressed) state proximal to the balloon 228 for insertion of the delivery apparatus 200 and prosthetic valve 212 into a subject’s vasculature, which is described in detail in U. S. Publication No. 2009 / 0281619, which is incorporated by reference herein. Because the prosthetic valve 212 is crimped at a location different from the location of balloon 228 (for example, in this case the prosthetic valve 212 is crimped proximal to balloon 228), the prosthetic valve 212 can be crimped to a lower profile than would be possible if prosthetic valve 212 was crimped on top of the balloon 228. This lower profile permits the user to more easily navigate the delivery apparatus (including crimped valve 212) through a subject’s vasculature to the treatment location. The lower profile of the crimped prosthetic valve is particularly helpful when navigating through portions of the subject’s vasculature which are particularly narrow, such as the iliac artery. The lower profile also allows for treatment of a wider population of subjects.

[0135] A nose cone 232 (FIGS. 5 A and 5B) (or distal tip) can be mounted at the distal end of the delivery apparatus 200 to facilitate advancement of the delivery apparatus 200 through the subject’s vasculature to the implantation site. In some instances, it may be useful to have nose cone 232 connected to a separate elongated shaft so that nose cone 232 can move independently of other elements of delivery apparatus 200.

[0136] As can be seen in FIG. 3 A, the balloon catheter 216 can include an inner shaft 234 that extends from the proximal portion 224 and coaxially through the outer balloon catheter shaft 226 (which can also be referred to as an “outer shaft”) and the balloon 228. In some examples, the nose cone 232 can be mounted on a distal end portion of the inner shaft 234.

[0137] In some examples, the nose cone 232 includes or is coupled to a distal shoulder 233 (which may be a polymeric body), which in turn is mounted on the distal end portion of the inner shaft 234, as shown in FIG. 5B.

[0138] In some examples, the nose cone 232 and distal shoulder 233 can be collectively referred to as a distal tip or distal tip assembly of the delivery apparatus 200.

[0139] In some examples, as shown in FIG. 5B, the inner shaft 234, distal shoulder 233, and nose cone 232 define a lumen configured to receive a guidewire therethrough. The delivery apparatus 200 can be advanced over the guidewire, which is inserted into a subject’s vasculature before the delivery apparatus.

[0140] In some examples, a mounting member 235 can be arranged around the inner shaft 234, within the balloon 228, to help secure a prosthetic valve on the balloon 228 once positioned there, as described herein (as shown in FIG. 5B).

[0141] The outer balloon catheter shaft 226 can be referred to as a “balloon shaft” or “balloon catheter shaft.” The balloon 228 can be supported on a distal end portion of inner shaft 234 that extends outwardly from and distal to the outer shaft 226, with a proximal end portion 236 of the balloon 228 secured to the distal end of the outer shaft 226 (FIG. 2). The outer diameter of inner shaft 234 is sized such that an annular space is defined between the inner shaft 234 and the outer shaft 226 along the entire length of the outer shaft 226. The proximal portion 224 of the balloon catheter can be formed with a fluid passageway (not shown) that is fluidly connectable to a fluid source (for example, saline) for inflating the balloon. The fluid passageway is in fluid communication with the annular space between inner shaft 234 and outer shaft 226 such that fluid from the fluid source can flow throughfluid passageway, through the space between the shafts, and into balloon 228 to inflate the same and deploy prosthetic valve 212.

[0142] The proximal portion 224 also defines an inner lumen that is in communication with a lumen 238 of the inner shaft 234 that is sized to receive a guide wire (not shown) that can extend coaxially through the inner shaft 234 and the nose cone 232.

[0143] The inner shaft 234 and balloon catheter shaft 226 (or outer shaft) of the balloon catheter can be formed from any of various suitable materials, such as nylon, braided stainless steel wires, or a polyether block amide (commercially available as Pebax®). The shafts 226, 234 can have longitudinal sections formed from different materials in order to vary the flexibility of the shafts along their lengths. The inner shaft 234 can have an inner liner or layer formed of Teflon® to minimize sliding friction with a guide wire.

[0144] The distal end portion of the guide catheter shaft 222 comprises a steerable section 268 (FIG. 4), the curvature of which can be adjusted by the operator to assist in guiding the apparatus through the subject’s vasculature, and particularly the aortic arch. The handle portion 220 (or handle 220) in the illustrated example comprises a distal handle portion 246 and a proximal handle portion 248. The distal handle portion 246 functions as a mechanism for adjusting the curvature of the distal end portion of the guide catheter shaft 222 and, in some examples, as a flex indicating device that allows a user to measure the relative amount of flex of the distal end of the guide catheter shaft 222. In some examples, the flex indicating device can provide a visual and tactile response at the handle the device, which provides a user with an immediate and direct way to determine the amount of flex of the distal end of the catheter.

[0145] The distal handle portion 246 can be operatively connected to the steerable section 268 and functions as an adjustment mechanism to permit operator adjustment of the curvature of the steerable section via manual adjustment of the handle portion. In some examples, the handle portion 246 can comprise a flex activating member 250, an indicator pin 252, and a cylindrical main body, or housing 254. As shown in FIGS. 3A and 3B, the flex activating member 250 comprises an adjustment knob 256 and a shaft 258 extending proximally from the knob into the housing 254. A proximal end portion of the guide catheter shaft 222 extends into and is fixed within the central lumen of the housing 254. An inner sleeve 270 surrounds a portion of the guide catheter shaft 222 inside the housing 254. A threaded slidenut 272 is disposed on and is slidable relative to the sleeve 270. The slide nut 272 is formed with external threads that mate with internal threads 260 of the shaft 258.

[0146] The slide nut 272 can be formed with two slots formed on the inner surface of the nut and extending the length thereof. The sleeve 270 can be formed with longitudinally extending slots that are aligned with the slots of the slide nut 272 when the slide nut is placed on the sleeve. Disposed in each slot is a respective elongated nut guide, which can be in the form of an elongated rod or pin 276. The pins 276 extend radially into respective slots in the slide nut 272 to prevent rotation of the slide nut 272 relative to the sleeve 270. By virtue of this arrangement, rotation of the adjustment knob 256 (either clockwise or counterclockwise) causes the slide nut 272 to move longitudinally relative to the sleeve 270 in the directions indicated by double-headed arrow 274 (FIG. 3B).

[0147] One or more pull wires 278 (FIG. 3A) couple the adjustment knob 256 to the steerable section 268 to adjust the curvature of the steerable section upon rotation of the adjustment knob. For example, the proximal end portion of the pull wire 278 can extend into and can be secured to a retaining pin, such as by crimping the pin around the proximal end of the pull wire, which pin is disposed in a slot in the slide nut 272. The pull wire can extend from the pin, through the slot in the slide nut, a slot in the sleeve 270, and into and through a pull wire lumen in the shaft 222. The distal end portion of the pull wire is secured to the distal end portion of the steerable section 268.

[0148] In some examples, the pin, which retains the proximal end of the pull wire 278, is captured in the slot in the slide nut 272. Hence, when the adjustment knob 256 is rotated to move the slide nut 272 in the proximal direction, the pull wire also is moved in the proximal direction. The pull wire pulls the distal end of the steerable section 268 back toward the handle portion, thereby bending the steerable section and reducing its radius of curvature. The friction between the adjustment knob 256 and the slide nut 272 is sufficient to hold the pull wire taut, thus preserving the shape of the bend in the steerable section if the operator releases the adjustment knob 256. When the adjustment knob 256 is rotated in the opposite direction to move the slide nut 272 in the distal direction, tension in the pull wire is released. The resiliency of the steerable section 268 causes the steerable to return its normal, nondeflected shape as tension on the pull wire is decreased. Because the pull wire is not fixedly secured to the slide nut 272 (the pin can move within the slot in the nut), movement of the slide nut in the distal direction does not push on the end of the pull wire, causing it to buckle.Instead, the pin is allowed to float within the slot of the slide nut 272 when the knob 256 is adjusted to reduce tension in the pull wire, preventing buckling of the pull wire.

[0149] In some examples, the steerable section 268 in its non-deflected shape is slightly curved and in its fully curved position, the steerable section generally conforms to the shape of the aortic arch. In some examples, the steerable section can be substantially straight in its non-deflected position.

[0150] The distal handle portion 246 can have other configurations that are adapted to adjust the curvature of the steerable section 268. One such alternative handle configuration is shown in U. S. Publication No. 2007 / 0005131, which is incorporated by reference herein in its entirety. Additional details relating to the steerable section and handle configuration discussed above can be found in U. S. Patent Publication Nos. US2008 / 0065011 and US2013 / 0030519, which are incorporated by reference herein in their entireties.

[0151] The shaft 258 can also include an externally threaded surface portion 262. As shown in FIG. 3B, a base portion 264 of the indicator pin 252 mates with the externally threaded surface portion 262 of the shaft 258. The shaft 258 extends into the housing 254 and the indicator pin 252 is trapped between the externally threaded surface portion 262 and the housing 254, with a portion of the indicator pin 252 extending into a longitudinal slot 266 of the handle. As the knob 256 rotated to increase the curvature of the distal end of the guide catheter shaft 222, the indicator pin 252 tracks the external threaded portion 262 of the flex activating member and moves in the proximal direction inside of the slot 266. The greater the amount of rotation of the knob 256, the further indicator pin 252 moves towards the proximal end of the proximal handle portion 246. Conversely, rotating the knob 256 in the opposite direction decreases the curvature of the distal end of the guide catheter shaft 222 (i.e., straightens the guide catheter shaft) and causes corresponding movement of the indicator pin 252 toward the distal end of the distal handle portion 246.

[0152] The outer surface of the housing 254 of the distal handle portion 246 can include visual indicia adjacent the slot 266 that indicate the amount of flex of the distal end of the guide catheter shaft 222, based on the position of the indicator pin 252 relative to the visual indicia. Such indicia can identify the amount of flex in any of a variety of manners. For example, the outer surface of the housing 254 can include a series of numbers (for example, 0 to 10) adjacent the slot that indicate the amount of curvature of the guide catheter shaft 222 based on the position of the indicator pin 252 relative to the number scale.

[0153] As described above, when the delivery apparatus is introduced into the vasculature of the subject, a crimped (or radially compressed) prosthetic valve 212 is positioned proximal to the balloon 228 (FIG. 5A). In some examples, as shown in FIG. 5B, the delivery apparatus 200 includes a relatively thin piece of tubing or a sleeve, which can be referred to herein as a crimp balloon 225, that couples a distal end of the balloon catheter shaft 226 to a proximal end (which may include and be referred to as a proximal leg 231) of the inflatable balloon 228. The crimp balloon 225 can be made of any of various polymers traditionally used for forming medical balloons (for example, nylon, Pebax, etc.). In some examples, the crimp balloon 225 and the balloon 228 are made of the same material. In some examples, the crimp balloon 225 can be at least partially inflated with an inflation fluid to partially expand a prosthetic valve mounted thereon prior to repositioning the prosthetic valve onto the balloon 228, as further described below.

[0154] Prior to expansion of the balloon 228 and deployment of prosthetic valve 212 at the treatment site, the prosthetic valve 212 is moved axially relative to the balloon (or vice versa) to position the crimped prosthetic valve on the balloon 228 for deploying (expanding) the prosthetic valve. For example, as discussed below, the proximal handle portion 248 can serve as an adjustment device that can be used to move the balloon 228 proximally into position within the frame of prosthetic valve 212, and further to accurately position the balloon and the prosthetic valve at the desired deployment location.

[0155] As shown in FIGS. 3 A and 3B, the proximal handle portion 248 comprises an outer housing 280 and an adjustment mechanism 282. The adjustment mechanism 282, which is configured to adjust the axial position of the balloon catheter shaft 226 relative to the guide catheter shaft 222, comprises an adjustment knob 284 and a shaft 286 extending distally into the housing 280. Mounted within the housing 280 on the balloon catheter shaft 226 is an inner support 288, which in turn mounts an inner shaft 290 (also referred to as a slider or sliding mechanism). The inner shaft 290 has a distal end portion 292 formed with external threads that mate with internal threads 294 that extend along the inner surface of the adjustment mechanism 282. The inner shaft 290 further includes a proximal end portion 296 that mounts a securement mechanism 298, which is configured to retain the position of the balloon catheter shaft 226 relative to the proximal handle portion 248 for use of the adjustment mechanism 282, as further described below. The inner shaft 290 can be coupled to the inner support 288 such that rotation of shaft 286 causes the inner shaft 290 to moveaxially within the handle. For example, the inner support 288 can have an axially extending rod or rail that extends into slot formed in the inner surface of the inner shaft 290. The rod or rail prevents rotation of the inner shaft 290 but allows it to move axially upon rotation of the shaft 286.

[0156] The securement mechanism 298 includes internal threads that mate with external threads of the proximal end portion 296 of the inner shaft. Mounted within the proximal end portion 296 on the balloon catheter shaft 226 is a pusher element 210 and a shaft engagement member in the form of a collet 202. The collet 202 is configured to be manipulated by the securement mechanism between a first state in which collet allows the balloon catheter shaft to be moved freely in the longitudinal and rotational directions and a second state in which the collet frictionally engages the balloon catheter shaft and prevents rotational and longitudinal movement of the balloon catheter shaft relative to the inner shaft 290.

[0157] As noted above, the securement mechanism 298 is operable to restrain movement of the balloon catheter shaft 226 (in the axial and rotational directions) relative to the proximal handle portion 248. In some examples, the securement mechanism 298 is movable between a proximal position (shown in FIGS. 3 A and 3B) and a distal position closer to the adjacent end of the knob 284. In the proximal position, the collet 202 applies little, if any, force against the balloon catheter shaft 226, which can slide freely relative to the collet 202, the entire handle portion 220, and the guide catheter shaft 222. When the securement mechanism 298 is rotated so as to move to its distal position closer to knob 284, the securement mechanism urges pusher element 210 against the proximal end of the collet 202. The holding force of the collet 202 against the balloon catheter shaft 226 locks the balloon catheter shaft 226 relative to the inner shaft 290. In the locked position, rotation of the adjustment knob 284 causes the inner shaft 290, the inner shaft 234, and the balloon catheter shaft 226 to move axially relative to the guide catheter shaft 222 (either in the proximal or distal direction, depending on the direction the knob 284 is rotated).

[0158] The adjustment knob 284 can be utilized to position the prosthetic valve 212 on the balloon 228 and / or once the prosthetic valve 212 is on the balloon 228, to position the prosthetic valve and the balloon at the desired deployment site within the native valve annulus.

[0159] One exemplary method for implanting the prosthetic valve 212 (which may be the prosthetic valve 100, in some examples) in the native aortic valve is as follows. Theprosthetic valve 212 initially can be crimped on a mounting region (FIG. 5A) of the delivery apparatus immediately adjacent the proximal end of the balloon 228 (such as on a crimp balloon and / or on the balloon catheter shaft 226). The proximal end of the prosthetic valve can abut the distal end 223 of the guide catheter shaft 222 (FIG. 5A), which keeps the prosthetic valve in place on the balloon catheter shaft or crimp balloon as the delivery apparatus and prosthetic valve are inserted through an introducer sheath. The prosthetic valve 212 can be delivered in a transfemoral procedure by first inserting an introducer sheath into the femoral artery and pushing the delivery apparatus through the introducer sheath into the subject's vasculature.

[0160] After the prosthetic valve 212 is advanced through the narrowest portions of the subject’s vasculature (for example, the iliac artery), the prosthetic valve 212 can be moved onto the balloon 228. For example, a convenient location for moving the prosthetic valve onto the balloon is the descending aorta or the ascending aorta. The prosthetic valve can be moved onto the balloon, for example, by holding the handle portion 246 steady (which retains the guide catheter shaft 222 in place) and moving the balloon catheter shaft 226 and the inner shaft 234 in the proximal direction relative to the guide catheter shaft 222. As the balloon catheter shaft and the inner shaft are moved in the proximal direction, the distal end 223 of the guide catheter shaft pushes against the prosthetic valve, allowing the balloon 228 to be moved proximally through the prosthetic valve in order to center the prosthetic valve on the balloon 228. The balloon catheter shaft can include one or more radiopaque markers to assist the user in positioning the prosthetic valve at the desired location on the balloon. The balloon catheter shaft 226 can be moved in the proximal direction by simply sliding / pulling the balloon catheter shaft in the proximal direction if the securement mechanism 298 is not engaged to retain the shaft 226. For more precise control of the shaft 226, the securement mechanism 298 can be engaged to retain the shaft 226, in which case the adjustment knob 284 is rotated to effect movement of the shaft 226 and the balloon 228. The axial position of the balloon shaft 226 can be fixed relative to the inner shaft 234, such that axial movement of the balloon shaft 226 relative to the outer shaft 222 produces axial movement of the balloon shaft 226, the inner shaft 234, and the balloon 228 relative to the outer shaft 222. In lieu of or in addition to moving the balloon shaft 226, the inner shaft 234, and the balloon 228 proximally relative to the outer shaft 222, repositioning of the prosthetic valve can beaccomplished by moving the outer shaft 222 distally relative to the balloon shaft 226, the inner shaft 234, and the balloon 228.

[0161] Further details on the delivery apparatus 200 can be found in U. S. Patent No.9,339,384, which is incorporated by reference herein in its entirety.

[0162] As introduced above, it may be desirable to rotate a prosthetic valve mounted on a delivery apparatus in a radially compressed configuration in order to achieve a desired circumferential or rotational orientation relative to the native anatomy, upon deployment of the prosthetic valve. In some examples, rotating the prosthetic valve with the delivery apparatus can allow for commissures of the prosthetic valve to be rotationally aligned with commissures of the native valve, thereby improving the performance of the implanted prosthetic heart valve.

[0163] In some examples, this rotation may occur after the prosthetic valve is moved from the crimp balloon 225 onto the inflatable balloon 228.

[0164] In some examples, this rotation may occur while the prosthetic valve is mounted off the inflatable balloon of the delivery apparatus (for example, as shown in FIG. 5A), such as on the crimp balloon 225.

[0165] However, due to the relatively thin construction of the crimp balloon, torque may not be effectively transferred from the balloon shaft to more distal portions of the delivery apparatus, such as the distal end of the crimp balloon, and to the inflatable balloon (and the prosthetic valve mounted thereon, for example). Further, in some examples, unwanted twisting or deformation of portions of the delivery apparatus can occur when attempting to rotate the prosthetic valve by transferring torque through the crimp balloon, thereby causing bending of the crimp balloon and unwanted movement of the prosthetic valve.

[0166] Thus, in some examples, a more rigid shaft of the delivery apparatus (such as the delivery apparatus 200) can extend to a proximal end of the inflatable balloon and be configured to receive a prosthetic valve radially compressed thereon and transfer torque to the inflatable balloon (thereby rotating a prosthetic valve mounted on the crimp balloon or on the inflatable balloon). In some examples, the more rigid shaft extends from a handle of the delivery apparatus to the proximal end of the inflatable balloon or to a distal shoulder or tip of the delivery apparatus.

[0167] FIGS. 6-10A depict examples of a torqueable inner shaft assembly 302 for a delivery apparatus 300. The delivery apparatus 300 can be similar to the delivery apparatus 200,except the inner shaft 234 is replaced by the inner shaft assembly 302 which extends through and is rotatable relative to the outer shaft 322 of the delivery apparatus 300 (the outer shaft 322 can be the same or similar to the outer shaft 222, as described above). The other components of the delivery apparatus 300 can be the same or similar to those of the delivery apparatus 200, and thus are numbered similarly in FIGS. 6-7B (for example, inflatable balloon 328 corresponds to inflatable balloon 228, and the crimp balloon 325 corresponds to the crimp balloon 225). In some instances, the inner shaft assembly 302 can be used in lieu of the inner shaft 234 in the delivery apparatus 200.

[0168] As shown in FIG. 6, the inflatable balloon 328 is arranged around the distal end portion of the inner shaft assembly 302 and the crimp balloon 325 extends around an outer surface of the inner shaft assembly 302, between the outer shaft 322 and the proximal leg 331 of the inflatable balloon 328.

[0169] The crimp balloon 325 can be mounted or bonded to a distal end of the balloon shaft 326, as shown in FIG. 6.

[0170] As best shown in FIGS. 7A-7B, the inner shaft assembly 302 includes an innermost shaft, or first shaft 304 defining a lumen 306 configured to receive a guidewire, and an outer shaft, or second shaft 308 that surrounds the first shaft 304.

[0171] In some examples, there is a gap 314 between the first shaft 304 and the second shaft 308. As such, the second shaft 308 surrounds, but is spaced away from in the radial direction, the first shaft 304.

[0172] The first shaft 304 can be non-porous such that it fluidly seals the lumen 306 from a remainder of the delivery apparatus 300. As such, no fluid can enter the lumen 306 from other lumens of the delivery apparatus 300.

[0173] The first shaft 304 can be the same or similar to the inner shaft 234 of delivery apparatus 200, in some examples.

[0174] In some examples, the first shaft 304 is braided or comprises a braided layer (such as a braided metal).

[0175] In some examples, the first shaft 304 does not include a braid or braided layer.

[0176] The second shaft 308 is configured to transfer torque along its length without twisting or distortion of the first shaft 304.

[0177] In some examples, the second shaft 308 is more rigid than the first shaft 304.

[0178] In some examples, the second shaft 308 comprises metal.

[0179] In some examples, the second shaft 308 comprises a dense array of wire. For example, the second shaft 308 can comprise one or more layers of coiled wire. An example of the second shaft 308 comprising a single layer of coiled wire is shown in FIG. 9, while an example of the second shaft 308 comprising multiple (for example, two) layers of coiled wire is shown in FIG. 8. The shaft 308 of FIG. 8 includes a first, inner layer 311a of coiled wire and a second, outer layer 311b of coiled wire extending coaxially over the first layer 311a.

[0180] In some examples, the one or more layers of coiled wire includes a first layer of coiled wire coiling in a first direction and a second layer of coiled wire coiling in a second direction that is different from the first direction.

[0181] In some examples, the one or more layers of coiled wire can comprise more than two layers of coiled wire, such as three, four, five layers or the like. In some examples, the multiple layers of coils can alternate coiling in opposite directions.

[0182] In some examples, multiple layers of coiled wire that coil or revolve in different directions can reduce the likelihood of the coils opening or collapsing when torqued in one or both directions. In this way, by incorporating multiple layers of overlapping coiled wire in which different layers coil in opposing directions, the second shaft 308 can be more robust and more effectively transfer torque along its length.

[0183] The coiled wire can include a flat wire 310 (that is, wire having a square or rectangular cross-sectional profile) (as shown in FIG. 8), a round wire 312 (as shown in FIG.9), or combinations thereof.

[0184] In some examples, the second shaft 308 is a metal hypotube. In such examples, the hypotube can, in some examples, comprise slits, cuts, or openings that provide the hypotube with increased flexibility.

[0185] Similar to the delivery apparatus 200, the delivery apparatus 300 can comprise a handle (such as handle portion 220) and the inner shaft assembly 302 can extend distally from the handle. In particular, the inner shaft assembly 302 can comprise a proximal portion that extends proximally from the handle to a connector having two ports, or a Y-connector, of the delivery apparatus (such as the proximal portion 224 shown in FIG. 2).

[0186] As shown in FIGS. 6-7B, the inner shaft assembly 302 extends to a distal tip of the delivery apparatus, which can include a distal shoulder 333 and nose cone 332, in some examples. In such examples, the nose cone 332 and distal shoulder 333 can be mounted orovermolded onto a distal end of the inner shaft assembly 302 (such as distal end of the first shaft 304, the second shaft 308, or both the first shaft 304 and second shaft 308).

[0187] In some examples, the distal shoulder 333 and nose cone 332 can be referred to as a distal tip assembly (or distal tip) of the delivery apparatus 300.

[0188] The first shaft 304 and second shaft 308 can be different lengths.

[0189] The first shaft 304 can extend from the connector (or proximal portion 224) to the distal end portion of the delivery apparatus, such as the distal shoulder 333 and / or nose cone 332, as depicted in FIGS. 6-7B.

[0190] In some examples, the second shaft 308 can extend from the connector (or proximal portion 224) to the proximal end portion (the proximal leg 331) of the inflatable balloon 328, as depicted in FIG. 7A and FIG. 10A.

[0191] In such examples, the distal end 316 of the second shaft 308, which may include a band 335 (as shown in FIG. 7A, for example), can be bonded to the proximal leg 331 of the inflatable balloon. As a result, torque can be transferred from the second shaft 308 to the inflatable balloon 328.

[0192] FIG. 10A depicts a detail view of a bond between the distal end 316 of the second shaft 308 and the proximal leg 331 of the inflatable balloon 328. In some examples, the proximal leg 331 can comprise multiple protrusions that are bonded to an outer surface or band around the distal end 316 of the second shaft 308. In some examples, the protrusions comprise slots or holes that allow inflation fluid to flow into the inflatable balloon 328.

[0193] FIG. 10B depicts an exemplary attachment interface 390 that can, in some examples, be used to connect the distal end 316 of the second shaft 308 to the proximal leg 331 of the inflatable balloon 328 (for example, in the dashed region shown in FIG. 10A). In some examples, the attachment interface 390 can be referred to as a coupling or coupler.

[0194] The attachment interface 390 is tubular and comprises a first end portion 392 that is configured to be coupled or bonded to the proximal leg 331 of the balloon 328, a second end portion 394 that is configured to be coupled or bonded (such as via welding) to the distal end 316 of the second shaft 308, and an intermediate portion 396 that tapers from the first end portion 392 to the second end portion 394.

[0195] The first end portion 392 can have a larger diameter than the second end portion 394, and thus the intermediate portion 396 can taper and transition radially inward from the first end portion 392 to the second end portion 394. The diameter of the first end portion 392 canbe sized to fit around or underneath the proximal leg 331 of the balloon 328 and the diameter of the second end portion 394 can be sized to fit against and be bonded to the distal end 316 of the second shaft 308.

[0196] In some examples, the second end portion 394 is welded (for example, laser welded) directly to the distal end 316 of the second shaft 308.

[0197] The first end portion 392 can include a plurality of spaced apart openings 398 that provide a fluid path for a polymer that is reflowed over the first end portion 392 mounted around or within the proximal leg 331, thereby bonding the overlapping parts together.Although the openings 398 are depicted in FIG. 10B as rectangular, the openings 398 can have various shapes and / or sizes, such as oblong, square, trapezoidal, or the like.

[0198] In some examples, as shown in FIG. 10B, the intermediate portion 396 can include a plurality of spaced apart openings 399 for receiving the reflowed polymer therethrough.

[0199] In some examples, the attachment interface 390 comprises a metal that is the same or similar to the metal of the second shaft 308 to which it is bonded (such as stainless steel).

[0200] In some examples, the second shaft 308 can extend from the connector (or proximal portion 224) to the distal end portion (which can also be referred to herein as a distal tip) of the delivery apparatus, such as the distal shoulder 333 and / or nose cone 332, as depicted in FIG. 7B. Thus, the second shaft 308 and the first shaft 304 can both extend through the inflatable balloon 228 to the distal tip of the delivery apparatus 300.

[0201] In such examples, the distal shoulder 333 and / or the nose cone 332 can be overmolded onto the distal end of the second shaft 308.

[0202] FIGS. 11A-13B depict examples of an advanceable shaft 402 for a delivery apparatus 400 that is movable between a first position where it is disposed inside an outer shaft 422 of the delivery apparatus 400 and retracted away from the crimp balloon 425 (as shown in FIG.12A) and a second position where it extends through the crimp balloon 425 toward or to the inflatable balloon 428 (as shown in FIG. 12B).

[0203] An inner shaft 434 of the delivery apparatus 400 can extend through the advanceable shaft 402 to a distal end (for example, a distal tip, such as the nose cone 232 of delivery apparatus 200) of the delivery apparatus 400.

[0204] The delivery apparatus 400 can be similar to the delivery apparatus 200, except it includes the advanceable shaft 402 that extends through the balloon shaft 426 and around the inner shaft 434. Components of the delivery apparatus 400 that are the same or similar tothose of the delivery apparatus 200 are given the same reference numbers increased by 200 in FIGS. 11A-13B (for example, inflatable balloon 428 corresponds to inflatable balloon 228 and the crimp balloon 425 corresponds to the crimp balloon 225).

[0205] The advanceable shaft 402 can translate in an axial direction (that is, in a direction of a central longitudinal axis 405 of the delivery apparatus 400), relative to the inner shaft 434 and the balloon shaft 426.

[0206] The advanceable shaft 402 can also rotate around the central longitudinal axis 405.

[0207] For example, the advanceable shaft 402 can rotate with the balloon shaft 426, relative to the outer shaft 422.

[0208] The advanceable shaft 402 can extend distally from the handle 420 to a distal end 404 of the advanceable shaft 402.

[0209] In some examples, when the advanceable shaft 402 is in the first position, its distal end 404 is positioned fully within the balloon shaft 426.

[0210] In some examples, when the advanceable shaft 402 is in the first position, its distal end 404 is positioned distal to a distal end of the balloon shaft 426 but does not extend a majority of the length (for example, more than half of the length) of the crimp balloon 425. For example, in the first position, the distal end 404 of the advanceable shaft 402 can be inside the crimp balloon 425, but not more than halfway into the crimp balloon 425.

[0211] In some examples, when the advanceable shaft 402 is in the second position, its distal end 404 is positioned at an interface between the crimp balloon 425 and the inflatable balloon 428 (as shown in FIG. 12B), such as within a proximal leg of the inflatable balloon 428.

[0212] The advanceable shaft 402 can be actuated to move between the first and second positions (and / or a plurality of positions therebetween) by an actuator on the handle 420 or an actuator mounted on a shaft proximal to the handle 420.

[0213] In some examples, as shown in FIG. 13A, a proximal end of the advanceable shaft 402 can attach to an activating member 406 (which can be a rotatable knob, for example). The activating member 406 is configured to translate the shaft 402 distally and proximally, thereby moving the distal end 404 of the advanceable shaft 402 into and out of the second position where it extends through the crimp balloon 425 or proximate to a proximal end portion of the inflatable balloon 428.

[0214] In some examples, the activating member 406 is a knob, and rotating the knob in a first direction results in translation of the advanceable shaft 402, relative to the balloon shaft426 and inner shaft 434, from the first position to the second position and rotating the knob in a second direction (opposite the first direction) results in translation of the advanceable shaft 402, relative to the balloon shaft 426 and the inner shaft 434 from the second position to the first position.

[0215] The activating member 406 can be part of an activator body 408 that is located proximal to the handle 420. In some examples, the activator body 408 can be incorporated into a proximal end portion of the handle 220.

[0216] The balloon shaft 426 can also extend proximally from the handle 420, to the activator body 408. The proximal end of the balloon shaft 426 can be fluidly coupled to an inflation port 410 in the activator body 408. As such, inflation fluid can be injected through the inflation port 410 into a lumen defined between an outer surface of the inner shaft 434 and an inner surface of the balloon shaft 426.

[0217] The inner shaft 434 can extend proximally beyond the activator body 408 to a guidewire lumen port 412 that is configured to receive a guidewire therethrough.

[0218] In some examples, as shown in FIG. 13B, the proximal end of the advanceable shaft 402 can attach to an activating member 414 incorporated into a proximal end portion 416 of the handle 420.

[0219] In some examples, the activating member 414 is a knob, and rotating the knob in a first direction results in translation of the advanceable shaft 402, relative to the balloon shaft 426 and inner shaft 434, from the first position to the second position and rotating the knob in a second direction (opposite the first direction) results in translation of the advanceable shaft 402, relative to the balloon shaft 426 and the inner shaft 434 from the second position to the first position.

[0220] The inflation port 410 can be incorporated into the proximal end portion 416, distal to the activating member 414. As such, a proximal end of the balloon shaft 426 can be positioned at an axial location of the inflation port 410, within the proximal end portion 416.

[0221] The inner shaft 434 can extend through the proximal end portion 416 to the guidewire lumen port 412.

[0222] In some examples, the distal end 404 of the advanceable shaft 402 can be free-floating (not attached to another component). In such examples, the distal end 404 can extend to or into the proximal end portion of the inflatable balloon 428 when in the second position.

[0223] In some examples, the distal end 404 of the advanceable shaft 402 can have a first mating feature 430 that is configured to mate with a second mating feature 432 on the proximal end portion of the inflatable balloon 428. As shown in the example of FIG. 11B, the first mating feature 430 is shaped like a gear or cog with protrusions that fit within complementary recesses of the second mating feature 432. In this way, when the shaft 402 is advanced into the second position, the first mating feature 430 can engage with the second mating feature 432, thereby transferring torque more effectively to the inflatable balloon 428 when the shaft 402 is rotated.

[0224] In some examples, the distal end 404 of the advanceable shaft 402 can have a first mating feature 436 that is configured to mate with a second mating feature 438 on the proximal end portion of the inflatable balloon 428. As shown in the example of FIG. 11C, the first mating feature 436 can have a shape (triangular, square, circular, star, or the like) that fits within a complementary recess or opening of the second mating feature 438. In this way, when the shaft 402 is advanced into the second position, the first mating feature 436 can fit within and engage with the second mating feature 438, thereby transferring torque more effectively to the inflatable balloon 428 when the shaft 402 is rotated.

[0225] The advanceable shaft 402 can be configured to bend, but also transfer torque along its length.

[0226] In some examples, the advanceable shaft 402 comprises a metal hypotube. In such examples, the hypotube can be a laser cut hypotube that, in some examples, comprises slits, cuts, or openings that provide the hypotube with increased flexibility, such as described in U. S. Provisional Patent Application Nos. 63 / 570,698, 63 / 651,279, and 63 / 688,649, all of which are incorporated by reference herein.

[0227] In some examples, the advanceable shaft 402 can comprise a plurality of interconnected struts defining a plurality of open cells (such as diamond-shaped cells). The struts can form a lattice structure (such as a diamond lattice).

[0228] In some examples, the advanceable shaft 402 can be a coil spring.

[0229] In some examples, the advanceable shaft 402 comprises a shape memory metal, such as Nitinol.

[0230] In some examples, the advanceable shaft 402 comprises a rigid polymer with channels, slits, openings, or the like that provide it with flexibility such that it can bend.

[0231] Additional examples of materials and configurations for shafts that can transfer torque and bend to navigate through a subject’s vasculature are described in U. S. Provisional Patent Application Nos. 63 / 570,698 and 63 / 651,279, which are already incorporated by reference above.

[0232] FIGS. 14-17B depict examples of a rotatable shaft 502 for a delivery apparatus, such as the delivery apparatus 200, that comprises two radially offset lumens (relative to a central longitudinal axis of the shaft 502). The two radially offset lumens include a first lumen 506 configured to receive inflation fluid for the inflatable balloon of the delivery apparatus and a second lumen 508 configured to receive a guidewire.

[0233] In some examples, the rotatable shaft 502 can replace the inner shaft 234 and the balloon shaft 226 in the delivery apparatus 200 and extend from the proximal portion 224 to the distal shoulder and / or nose cone 232.

[0234] For example, a proximal end of the shaft 502 can be bonded to the proximal portion 224, which in some examples may be a connector. For example, as shown in FIG. 2, the proximal portion 224 can be a connector, or Y-connector, having a first port 219 that is fluidly coupled to the first lumen 506 and configured to receive inflation fluid. The connector can also have a second port 221 that is aligned with the second lumen 508 and configured to receive a guidewire.

[0235] A distal end of the shaft 502 can be coupled to a distal tip of the delivery apparatus. For example, the distal end of the shaft 502 can be coupled to the nose cone 232 of the delivery apparatus 200, or a nose cone and distal shoulder assembly comprising the nose cone 232 and the distal shoulder 533, as shown in FIG. 17. As such, the shaft 502 can extend distally from the handle or handle portion 220 of the delivery apparatus to a distal tip of the delivery apparatus 500.

[0236] As shown in FIGS. 14 and 16, the rotatable shaft 502 comprises a main section 504 with an axially extending first lumen 506 and an axially extending second lumen 508 that are fluidly separated and radially offset from one another inside the main section 504. In some examples, as shown in FIG. 15, the first lumen 506 and the second lumen 508 are both radially offset from a central longitudinal axis 505 of the shaft 502. The shaft 502 also comprises an extension portion 510 extending from a distal end 512 of the main section 504. The second lumen 508 further extends through the extension portion 510.

[0237] The main section 504 has a first outer diameter 514 and the extension portion has a second outer diameter 516 that is smaller than the first outer diameter 514.

[0238] In some examples, the shaft 502 comprises a polymer. For example, the main section can comprise a polymeric casing with the first lumen 506 and second lumen 508 defined therein. The extension portion 510 can also comprise a polymeric casing that is an extension or extrusion of a portion of the main section, with the second lumen 508 defined therein.

[0239] In some examples, the shaft 502 comprises one or more braided layers embedded within the polymer or polymer casing of the shaft 502. The one or more braided layers can add rigidity to the shaft 502 and improve its ability to transfer torque.

[0240] In this way, the first lumen 506 extends through only the main section 504, and a first, distal opening 518 of the first lumen 506 is defined in the distal end 512 of the main section 504.

[0241] The second lumen 508 extends through both the main section 504 and the extension portion 510.

[0242] FIGS. 17A and 17B depict a distal end portion of a delivery apparatus 500 that may be similar to the delivery apparatus 200, except it includes the rotatable shaft 502 in place of the inner shaft 234 and balloon shaft 226. The delivery apparatus 500 comprises an inflatable balloon 528, which can be similar to the inflatable balloon 228 of the delivery apparatus 200.

[0243] However, in some examples, a proximal end portion or proximal leg 531 of the inflatable balloon 528 can be coupled (for example, bonded) to a portion of the rotatable shaft 502 (effectively replacing the crimp balloon), as shown in FIG. 17A.

[0244] In some examples, the distal end 512 of the main section 504 can comprise a step 520 that steps radially inward from the first outer diameter 514 of the main section 504. The step 520 can provide a ledge or surface for bonding the proximal leg 531 thereto (as shown in FIG. 17A) or for bonding the crimp balloon 525 thereto (as shown in FIG. 17B).

[0245] In some examples, the delivery apparatus 500 can include a crimp balloon 525, similar to the crimp balloon 225, and the proximal leg 531 of the inflatable balloon 528 can be coupled (for example, bonded) to the crimp balloon 525 and the crimp balloon 525 can be coupled to a portion of the rotatable shaft 502 (such as the step 520 at the distal end 512, as shown in FIG. 17B).

[0246] As shown in FIGS. 17 A and 17B, the extension portion 510 of the shaft 502 extends through an inside of the inflatable balloon 528 to the distal shoulder 533 and nose cone 532.In some examples, the distal shoulder 533 and nose cone 532 can be formed as one piece and referred to as a distal tip assembly, or simply a distal tip of the delivery apparatus 500. In some examples, one or both of the distal shoulder 533 and the nose cone 532 can be referred to as the distal tip of the delivery apparatus 500.

[0247] In some examples, the distal shoulder 533 (or distal tip) is overmolded onto a distal end of the extension portion 510.

[0248] The distal shoulder 533 and nose cone 532 define a lumen that is continuous with the second lumen 508, and the nose cone 532 has a distal opening 526 that allows for passage of a guidewire therethrough.

[0249] A diameter of the second lumen 508 can be sized such that the guidewire can extend through the second lumen 508.

[0250] The proximal leg 531 of the inflatable balloon 528 is coupled (for example, bonded) to the distal end 512 of the main section 504 of the shaft 502. As such, the first lumen 506 is fluidly coupled with an interior of the inflatable balloon 528, via the first opening 518.

[0251] The first lumen 506 is configured to receive inflation fluid and direct the inflation fluid to flow from a proximal end of the shaft 502 into the balloon 528, as described above. As such, a diameter of the first lumen 506 can be sized such that a specified amount of inflation fluid can flow into and inflate the inflatable balloon 528.

[0252] The extension portion, with the proximal leg arranged therearound, is configured to receive a prosthetic valve in a radially compressed configuration. Before deployment, the prosthetic valve can be moved from a location around the portion of the extension portion arranged within the proximal leg 531 to a location over the inflatable body 527 of the inflatable balloon 528.

[0253] The rotatable shaft 502 is configured such that it transfers torque along its length, thereby effectively rotating the prosthetic valve mounted thereon. For example, the shaft 502 can rotate the prosthetic valve as desired, whether mounted around the proximal leg 531 or the inflatable body 527 of the inflatable balloon 528.

[0254] FIGS. 18A-19B depict examples of a rotatable shaft 602 for a delivery apparatus 600, such as the delivery apparatus 200, that comprises a locking tip 604 at its distal end. In some examples, the locking tip 604 can be referred to as a flex tip or distal tip. The locking tip 604 is movable from a first position where the locking tip 604 is disengaged from a proximal end portion of an inflatable balloon 628 of the delivery apparatus 600, to a second position wherethe locking tip 604 is engaged with the proximal end portion of the inflatable balloon 628. As a result, rotating the shaft 602, while the locking tip 604 is in the second position, transfers rotation of the shaft 602 to the inflatable balloon 628 such that a prosthetic valve mounted on the inflatable balloon 628 rotates.

[0255] The delivery apparatus 600 can be similar to the delivery apparatus 200. For example, an inner shaft 634 of the delivery apparatus 600 can extend through the shaft 602. In some examples, the shaft 602 and its locking tip 604 can be used in lieu of shaft 226 in the delivery apparatus 200.

[0256] For example, the locking tip 604 can include a plurality of flexible fingers 606 or projections that are movable into and out of engagement with a proximal leg 631 of, or shaft attached to, the inflatable balloon 628 of the delivery apparatus 600. When engaged, the rotatable shaft (via the fingers 606 of the locking tip 604) can effectively transfer torque to the inflatable balloon 628, thereby allowing rotation of the prosthetic valve mounted thereon.

[0257] In some examples, the rotatable shaft 602 can be used in lieu of the balloon shaft 226 in the delivery apparatus 200.

[0258] The locking tip 604 can be attached to a distal end of the rotatable shaft 602, in some examples.

[0259] The fingers 606 can include a plurality of fingers (for example, two, three, four, or the like) that are spaced circumferentially apart from one another.

[0260] In some examples, the locking tip 604 is molded or bonded onto the distal end of the rotatable shaft 602. For example, each finger 606 can be bonded to the distal end of the rotatable shaft 602, or the fingers 606 can extend from an annular portion of the locking tip 604 that is bonded to the distal end of the rotatable shaft 602.

[0261] The fingers 606 of the locking tip 604 can be configured to flex radially inward and outward relative to a central longitudinal axis 605 of the delivery apparatus 600. In some examples, the resting state of the fingers 606 can be the radially outward position shown in FIGS. 18A and 19A, where the fingers 606 are disengaged from the proximal leg 631 of the inflatable balloon 628. The fingers 606 are configured to flex and pivot from their attached ends 608, in response to an applied force, until the free ends 610 of the fingers 606 engage (which may be referred to as “locking” onto) the proximal leg 631 of the inflatable balloon 628, or a more rigid shaft coupled between the crimp balloon 625 and the proximal leg 631 of the inflatable balloon 628.

[0262] In particular, the fingers 606 are movable between a first position where they are spaced radially away from the crimp balloon 625 and the proximal leg 631 of the inflatable balloon 628 (as shown in FIGS. 18A and 19 A) and a second position where the fingers 606 are moved toward and clamp (or lock) onto the proximal leg 631 of the inflatable balloon 628 (as shown in FIGS. 18B and 19B). As a result, when the rotatable shaft 602 rotates, the rotation (or torque) is transferred along the fingers 606 to the inflatable balloon 628, thereby enabling a prosthetic valve mounted thereon to rotate along with the rotatable shaft 602.

[0263] In some examples, the fingers 606 (and / or the entire locking tip 604) comprise a polymer that is configured to allow the fingers 606 to flex or move between the first and second positions.

[0264] In some examples, the polymer is a rigid but flexible polymer, such as a polyether block amide (for example, Pebax), Nylon, or PEEK.

[0265] The fingers 606 can be actuated or moved into the second position (FIGS. 18B and 19B) by an applied force. Upon removal of the force, the fingers 606 can return to the first position (FIGS. 18A and 19A).

[0266] In some examples, as shown in FIGS. 18A and 18B, the applied force is from a pull ring 612 that encircles the rotatable shaft 602 in the first position (as shown in FIG. 18 A) and encircles the fingers 606 in the second position (as shown in FIG. 18B).

[0267] A diameter of the pull ring 612 can be smaller than a diameter of the locking tip 604 at a distal end portion of the fingers 606, when the fingers 606 are in the first position (the relaxed or resting state). The diameter of the pull ring 612 can also be smaller than an inner diameter of an outer shaft of the delivery apparatus (such as outer shaft 222). As such, the pull ring 612 can fit inside the outer shaft of the delivery apparatus in some examples,

[0268] The pull ring 612 can be connected to relatively thin pull wires 614. In some examples, the pull wires 614 can extend to the handle (such as the handle portion 220 shown in FIG. 2) of the delivery apparatus 600 and be connected to an actuator of the handle that is configured to push and pull the wires 614 back and forth (into the first and second positions).

[0269] In some examples, as shown in FIGS. 19A and 19B, the applied force is from a shaft 616. In some examples, the shaft 616 is the outer flex shaft of the delivery apparatus 600 (for example, shaft 222 of delivery apparatus 200). In such examples, the rotatable shaft 602 is pulled toward the handle of the delivery apparatus 600 (and away from the inflatable balloon628), thereby pulling the fingers 606 into the shaft 616 which pushes the fingers 606 into the second position (as shown in FIG. 19B).

[0270] In some examples, the shaft 616 is an additional shaft that is translatable, in a direction of the central longitudinal axis 605, over and off the fingers 606. In such examples, the shaft 616 is pushed toward the inflatable balloon 628 and over the fingers 606 which pushes the fingers 606 into the second position (as shown in FIG. 19B).

[0271] For example, the shaft 616 can extend distally from a handle of the delivery apparatus, in some examples, and extend through an outer shaft of the delivery apparatus 600 and over the rotatable shaft 602.

[0272] FIGS. 20 and 21 depict examples of a rotatable distal tip 702 at a distal end of a shaft 722 of a delivery apparatus 700. The distal tip 702 is configured to rotate, about the central longitudinal axis 705 of the delivery apparatus 700, relative to other shafts of the delivery apparatus 700, such as the inner shaft 734 and the balloon shaft 726.

[0273] The delivery apparatus 700 can be similar to the delivery apparatus 200. For example, an inner shaft 734 of the delivery apparatus 700 can be similar to the inner shaft 234 and the balloon shaft 726 can be similar to the shaft 226 of the delivery apparatus 700. As described above for delivery apparatus 200, the shaft 722 (which can be similar to the shaft 222) and the balloon shaft 726 can be axially movable relative to one another. In this way, the distal tip 702 can be used to move the prosthetic valve 100 onto the inflatable balloon 728, as described further below. Although not shown, the delivery apparatus 700 can include a crimp balloon (for example, crimp balloon 225) that extends from the proximal end of the inflatable balloon 728 to the distal end of the balloon shaft 726.

[0274] In some examples, the shaft 722 and distal tip 702 can be used in lieu of shaft 222 in the delivery apparatus 200.

[0275] In some examples, the distal tip 702 can be configured to flex outward or compress inward in a radial direction, and thus can be referred to as a flex tip of the delivery apparatus 700. For example, the distal tip 702 can be configured to flex radially outward and receive at least a portion of the inflatable balloon 728 of the delivery apparatus 700 inside the distal tip 702 when the distal tip 702 is positioned over a proximal end portion of the balloon, as shown in FIG. 20.

[0276] In some examples, the shaft 722, which can be referred to as the outer shaft 722, can be configured to rotate relative to the balloon shaft 726, thereby rotating the distal tip 702 which defines a distal end of the outer shaft 722.

[0277] In some examples, the distal tip 702 is freely rotatable relative to a main shaft portion 723 of the outer shaft 722. For example, the distal tip 702 can rotate, around the central longitudinal axis 705, while the shaft portion 723 of the outer shaft 722 remains stationary. This can be achieved by a rotatable coupling 704 (which can also be referred to as a rotating joint or rotary joint) arranged between the shaft portion 723 and the distal tip 702. The rotatable coupling 704 can couple the distal tip 702 to the distal end of the shaft portion 723 but allow the distal tip 702 to rotate relative to the shaft portion 723.

[0278] In some examples, the rotatable coupling 704 is fluid tight or fluidly sealed such that fluid inside the shaft portion 723 is transferred to the inside of the distal tip 702 without leakage through the rotatable coupling 704.

[0279] During an implantation procedure using the delivery apparatus 700, in some examples, the prosthetic valve 100 can be initially crimped on the crimp balloon for insertion into the subject’s body and then advanced onto the inflatable balloon, such as by advancing the shaft 722 distally relative to the inner shaft 734 and the balloon shaft 726 and / or retracting the inner shaft 734 and the balloon shaft 726 proximally relative to the shaft 722. As the shaft 722 is advanced distally and / or the shafts 726, 734 are retracted proximally, the distal tip 702 pushes against the prosthetic valve 100 to move it from its initial position into the inflatable balloon 728.

[0280] Once the prosthetic valve 100 (or other prosthetic device) is arranged around the inflatable balloon 728 (as shown in FIGS. 20 and 21), rotational alignment of the prosthetic valve relative to the implantation site (for example, the native valve) can be performed by rotating the balloon shaft 726 and the inner shaft 734, which thereby rotates the balloon 728 and the prosthetic valve 100 mounted thereon. The distal tip 702, which extends over the proximal end portion of the balloon 728 and which may be in contact with the prosthetic valve, can rotate with the prosthetic valve and the balloon 728. Allowing rotation of the distal tip 702 avoids relative rotation between the distal tip 702 and the balloon 728, which can cause the balloon to the rub against the inner surface of the distal tip and produce unwanted torque build up along the shaft 722. By allowing the distal tip 702 to freely rotateas the balloon 728 rotates due to rotation of the balloon shaft 726. this torque buildup is avoided and the delivery apparatus 700 can operate more smoothly.

[0281] In some examples, as shown in FIG. 21, a distal end of the distal tip 702 is configured to interface with a prosthetic device, such as the prosthetic valve 100, mounted on the delivery apparatus 700. For example, the distal end 706 can comprise mating features 708 that are configured to mate with a proximal end of the prosthetic valve 100. In some examples, the mating feature 708 can mate with struts or apices at the proximal end of the frame 102 of the prosthetic valve 100, as depicted in FIG. 21. For example, the mating features 708 can comprises teeth, ridges, slots, or other indentations that are configured to receive apices or another portion of the prosthetic valve 100 therein.

[0282] In some examples, the distal tip 702 is configured to actively rotate the prosthetic valve 100 on the balloon 228, thereby transferring torque directly to the prosthetic valve 100. For example, by rotating the distal tip 702, either by itself or via rotation of the entire outer shaft 722, the prosthetic valve 100 can be rotated into a desired rotational position relative to the native anatomy or implantation site, without needing to transfer torque from the balloon shaft 726 to the balloon 728 via a crimp balloon or other component.

[0283] For example, when the distal tip 702 is freely rotatable relative to the shaft portion 723 of the outer shaft 722, and once the distal tip 702 is translated into mating contact with the prosthetic valve 100 (for example, by translating the outer shaft 722 relative to the balloon shaft 726), the distal tip 702 can be actuated to rotate by a specified amount, thereby rotating the prosthetic valve 100. In some examples, one or more pull wires (or alternate actuating members) can be coupled to the distal tip 702 and extend to a handle portion of the delivery apparatus 700 (such as handle portion 220 of the delivery apparatus 200). In this way, in some examples, rotating the prosthetic valve into a desired rotational position relative to the implantation site can include actuating one or more actuating members to rotate the distal tip 702 by the specified amount.

[0284] In some examples, the distal tip 702 can be fixed to the shaft 722 such that rotation of the shaft 722 at its proximal end (where it can be connected to the handle of the delivery apparatus) is effective to transfer rotation of the shaft 722 to the tip 702 and the prosthetic valve 100 to rotate the prosthetic valve relative to the balloon 728.

[0285] It should be noted that the distal tip 702 (with or without the coupling member 704) described above with reference to FIGS. 20 and 21 can be combined with any of the otherexamples described herein, such as any of the other torque transferring features described above with reference to FIGS. 6-19B. In some examples, the distal tip 702 (with or without the coupling member 704) can be incorporated into the shaft 222 of FIGS. 1-5B.

[0286] The various delivery apparatus shafts and mechanisms described herein can enable effective torque transfer from a rotatable shaft (for example, a balloon shaft) to the inflatable balloon of the delivery apparatus (without any unwanted distortion to the delivery apparatus or movement of the distal end portion of the delivery apparatus, for example). As a result, the prosthetic valve can be rotated on the delivery apparatus to orient it relative to the native anatomy prior to deployment. Furthermore, the various shafts described herein can be configured to bend as the delivery apparatus navigates curves in a subject’s vasculature. In some examples, the various shafts described herein can be axially compressible, thereby enabling such shafts to extend underneath an inflatable balloon and shorten as the inflatable balloon inflates.

[0287] In some examples, a method of delivering and deploying a prosthetic valve at an implantation site (for example, a native aortic valve) is as follows. The prosthetic valve can be crimped on the distal end portion of a delivery apparatus at a location offset from the central portion of an inflatable balloon (for example, balloon 228), such as on a crimp balloon 225 (any other crimp balloon disclosed herein), a proximal leg of a balloon, or directly on a shaft extending between the balloon shaft to the inflatable balloon. After valve crimping, the distal end portion of the delivery apparatus (along with the prosthetic valve) is inserted into the subject’s vasculature. In some examples, the distal end portion of the delivery apparatus (along with the prosthetic valve) is inserted through an introducer sheath previously inserted into a vessel (such as a femoral artery) and into the vasculature. In some examples, the delivery apparatus is advanced over a guidewire, previously inserted into the vasculature, which extends through a guidewire lumen of the delivery apparatus.

[0288] Once inside the subject’s vasculature, the prosthetic valve can be repositioned onto the central portion (or inflatable body) of the inflatable balloon, such as by moving the shaft 222 distally relative to the balloon shaft (for example, shaft 226) and / or moving the balloon shaft proximally relative to the shaft 222, as previously described. Repositioning of the prosthetic valve can occur, for example, within the descending aorta or the ascending aorta. After repositioning the prosthetic valve, the delivery apparatus can be advanced to position the prosthetic valve near the intended implantation site. For example, when implanting theprosthetic valve within the native aortic valve, the prosthetic valve can be positioned within the ascending aorta downstream the native aortic valve. At this time, the delivery apparatus can be rotated to produce rotation of the prosthetic valve and achieve rotational alignment of the prosthetic valve with a location or landmark of the native anatomy. Rotation of the prosthetic valve can be accomplished by locking or fixing the balloon shaft (for example, shaft 226) and the inner shaft 234 against rotation relative to the handle portion (such as by actuating securement mechanism 298) and the rotating the handle portion 220, which in turn rotates the balloon shaft 226, the inner shaft 234, the balloon 228, and the prosthetic valve. Alternatively, the prosthetic valve can be rotated by gripping and rotating a proximal end portion of the balloon shaft 226 or proximal portion 224, which is effective to rotate the balloon shaft 226, the inner shaft 234, the balloon 228, and the prosthetic valve. Various imaging techniques can used to rotationally align the prosthetic valve with respect to the native annulus. Further details of methods and devices for rotationally aligning a prosthetic valve with respect to the native annulus are disclosed in PCT Patent Publication Nos. WO 2022 / 046585 and WO 2024 / 015267, which are incorporated by reference herein in their entireties.

[0289] Following rotational alignment of the prosthetic valve, the delivery apparatus can be further advanced to position the prosthetic valve within the native aortic annulus (or other implantation site) and the balloon is inflated to deploy the prosthetic valve.Delivery Techniques

[0290] 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). Additionally and / 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 aorticvalve. Additionally and / 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 -sternotomy or right parasternal mini -thoracotomy, and then advanced through the ascending aorta toward the native aortic valve.

[0291] 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 and / 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,

[0292] 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.

[0293] 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 ator near the base of the heart) for implanting the prosthetic valve within the native tricuspid valve, the native pulmonary valve, or the pulmonary artery.

[0294] 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 delivery procedures and delivery devices known in the art.

[0295] 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 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.Simulation

[0296] 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

[0297] 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.

[0298] Example 1. A delivery apparatus for a prosthetic device, comprising a handle; a rotatable first shaft extending distally from the handle; a second shaft extending distally from the handle and through the first shaft and having a distal end portion extending distally beyond a distal end of the first shaft; an inflatable balloon arranged around the distal end portion of the second shaft; a crimp balloon extending from the first shaft to the inflatableballoon, the crimp balloon disposed around the second shaft; and a rotatable third shaft extending distally from the handle and through the first shaft and around the second shaft, wherein the third shaft is configured to extend through the crimp balloon and receive a prosthetic valve in a radially compressed configuration.

[0299] Example 2. The delivery apparatus of any example herein, particularly example 1, wherein a distal end of the third shaft is coupled to a proximal end portion of the inflatable balloon.

[0300] Example 3. The delivery apparatus of any example herein, particularly example 1, wherein a distal end of the third shaft is coupled to a distal tip of the delivery apparatus.

[0301] Example 4. The delivery apparatus of any example herein, particularly example 3, wherein the distal tip includes a nose cone.

[0302] Example 5. The delivery apparatus of any example herein, particularly any one of examples 1 -4, wherein the third shaft comprises metal.

[0303] Example 6. The delivery apparatus of any example herein, particularly any one of examples 1-5, wherein the third shaft comprises an array of metal wire.

[0304] Example 7. The delivery apparatus of any example herein, particularly example 6, wherein the third shaft comprises one or more layers of coiled wire.

[0305] Example 8. The delivery apparatus of any example herein, particularly example 7, wherein the one or more layers of coiled wire includes a first layer of coiled wire coiling in a first direction and a second layer of coiled wire coiling in a second direction that is different from the first direction.

[0306] Example 9. The delivery apparatus of any example herein, particularly any one of examples 1-8, wherein the third shaft is a metal hypotube.

[0307] Example 10. The delivery apparatus of any example herein, particularly any one of examples 1-9, wherein there is a gap between the second shaft and the third shaft.

[0308] Example 11. The delivery apparatus of any example herein, particularly example 1, wherein the third shaft is translatable, in a direction of a central longitudinal axis of the delivery apparatus, relative to the first shaft and the second shaft such that the third shaft is movable between a first position where it is disposed inside the first shaft and away from the crimp balloon and second position where it extends underneath the crimp balloon toward the inflatable balloon.

[0309] Example 12. The delivery apparatus of any example herein, particularly example 11, further comprising an activating member that is configured to move the third shaft between the first and second positions, wherein a proximal end of the third shaft is coupled to the activating member.

[0310] Example 13. The delivery apparatus of any example herein, particularly example 12, wherein the activating member is part of the handle.

[0311] Example 14. The delivery apparatus of any example herein, particularly example 12, wherein the activating member is disposed proximal to the handle in an activator body that further comprises an inflation port that is fluidly coupled with a proximal end of the first shaft.

[0312] Example 15. The delivery apparatus of any example herein, particularly any one of examples 11-14, wherein the third shaft is a laser cut hypotube with one or more slits or openings that allow it to bend.

[0313] Example 16. The delivery apparatus of any example herein, particularly any one of examples 11-14, wherein the third shaft comprises Nitinol.

[0314] Example 17. An assembly comprising the delivery apparatus of any example herein, particularly any one of examples 1-16, and further comprising a prosthetic valve mounted in a radially collapsed configuration around the crimp balloon and the third shaft, when the third shaft is arranged underneath the crimp balloon.

[0315] Example 18. The assembly of any example herein, particularly example 17, wherein the delivery apparatus further comprises a fourth shaft that surrounds and extends along the first shaft, wherein the fourth shaft and the first shaft are axially movable relative to one another such that the radially collapsed prosthetic valve is movable from a position around the crimp balloon to a position around an inflatable body of the inflatable balloon, and wherein the delivery apparatus is configured to inflate the inflatable balloon and radially expand the prosthetic valve.

[0316] Example 19. The assembly of any example herein, particularly example 18, wherein the fourth shaft is steerable and configured to flex about a central longitudinal axis of the delivery apparatus, and wherein the fourth shaft comprises a distal tip that is freely rotatable relative to a shaft portion of the fourth shaft.

[0317] Example 20. A delivery apparatus for a prosthetic device, comprising a first shaft; a shaft assembly extending through the first shaft and having a distal end portion extendingdistally beyond a distal end of the first shaft, wherein the shaft assembly is rotatable relative to the first shaft and comprises a second shaft defining a lumen configured to receive a guidewire; and a third shaft that is configured to transfer torque along its length, wherein the third shaft surrounds the second shaft; an inflatable balloon arranged around the distal end portion of the shaft assembly, wherein the third shaft extends to at least a proximal end portion of the inflatable balloon; and a crimp balloon extending around an outer surface of the third shaft and coupled to a proximal end of the inflatable balloon.

[0318] Example 21. The delivery apparatus of any example herein, particularly example 20, wherein the second shaft is coupled to a distal tip of the delivery apparatus.

[0319] Example 22. The delivery apparatus of any example herein, particularly example 21, wherein the distal tip comprises a nose cone.

[0320] Example 23. The delivery apparatus of any example herein, particularly either example 21 or example 22, wherein the third shaft is coupled to the proximal end portion of the inflatable balloon.

[0321] Example 24. The delivery apparatus of any example herein, particularly either example 21 or example 22, wherein the third shaft is coupled to the distal tip.

[0322] Example 25. The delivery apparatus of any example herein, particularly example 24, wherein the distal tip is overmolded onto a distal end of the third shaft.

[0323] Example 26. The delivery apparatus of any example herein, particularly any one of examples 20-25, further comprising a handle, and wherein proximal portions of the second shaft and third shaft extend proximally from the handle to a connector.

[0324] Example 27. The delivery apparatus of any example herein, particularly example 26, wherein the connector comprises a first port that is fluidly coupled to a lumen of the third shaft, and wherein the connector comprises a second port that is aligned with a lumen of the second shaft and configured to receive a guidewire.

[0325] Example 28. The delivery apparatus of any example herein, particularly either example 26 or example 27, wherein the first shaft extends distally from the handle, and wherein the handle comprises an adjustment mechanism configured to adjust a curvature of a distal end portion of the first shaft.

[0326] Example 29. The delivery apparatus of any example herein, particularly any one of examples 20-28, wherein the second shaft is a braided shaft.

[0327] Example 30. The delivery apparatus of any example herein, particularly any one of examples 20-29, wherein the third shaft comprises metal.

[0328] Example 31. The delivery apparatus of any example herein, particularly any one of examples 20-30, wherein the third shaft comprises a dense array of wire.

[0329] Example 32. The delivery apparatus of any example herein, particularly example 31, wherein the third shaft comprises one or more layers of coiled wire.

[0330] Example 33. The delivery apparatus of any example herein, particularly example 32, wherein the one or more layers of coiled wire includes a first layer of coiled wire coiling in a first direction and a second layer of coiled wire coiling in a second direction that is different from the first direction.

[0331] Example 34. The delivery apparatus of any example herein, particularly any one of examples 20-30, wherein the third shaft is a hypotube.

[0332] Example 35. The delivery apparatus of any example herein, particularly any one of examples 20-34, wherein there is a gap between the second shaft and the third shaft.

[0333] Example 36. An assembly comprising the delivery apparatus of any example herein, particularly any one of examples 20-35, and further comprising a prosthetic valve mounted in a radially collapsed configuration around the crimp balloon and third shaft.

[0334] Example 37. The assembly of any example herein, particularly example 36, wherein the delivery apparatus further comprises a fourth shaft extending through the first shaft and around the shaft assembly, wherein a proximal end of the crimp balloon is coupled to the fourth shaft.

[0335] Example 38. The assembly of any example herein, particularly example 37, wherein the first shaft and the fourth shaft are axially movable relative to one another such that the radially collapsed prosthetic valve is movable from the crimp balloon to a position around the inflatable balloon, wherein the delivery apparatus is configured to inflate the inflatable balloon and radially expand the prosthetic valve, and wherein the first shaft comprises a flex tip at its distal end that is configured to freely rotate relative to a remainder of the first shaft.

[0336] Example 39. A delivery apparatus for a prosthetic device, comprising a rotatable first shaft: a second shaft extending through the first shaft and having a distal end portion extending distally beyond a distal end of the first shaft; an inflatable balloon arranged around the distal end portion of the second shaft; a crimp balloon extending from the first shaft to the inflatable balloon, the crimp balloon disposed around the second shaft; and a rotatable thirdshaft extending through the first shaft and around the second shaft, wherein the third shaft is translatable, in a direction of a central longitudinal axis of the delivery apparatus, relative to the first shaft and second shaft such that the third shaft is movable between a first position where it is disposed inside the first shaft and away from the crimp balloon and second position where it extends through the crimp balloon toward the inflatable balloon.

[0337] Example 40. The delivery apparatus of any example herein, particularly example 39, wherein in the second position, a distal end of the third shaft is located within a proximal end portion of the inflatable balloon.

[0338] Example 41. The delivery apparatus of any example herein, particularly either example 39 or example 40, wherein a proximal end of the crimp balloon is coupled to a distal end of the first shaft.

[0339] Example 42. The delivery apparatus of any example herein, particularly any one of examples 39-41, wherein a distal end of the third shaft is free-floating.

[0340] Example 43. The delivery apparatus of any example herein, particularly any one of examples 39-41, wherein a distal end of the third shaft includes a mating feature that interfaces with a complementary mating feature defining a proximal end portion of the inflatable balloon.

[0341] Example 44. The delivery apparatus of any example herein, particularly any one of examples 39-43, wherein the third shaft comprises metal.

[0342] Example 45. The delivery apparatus of any examples herein, particularly any one of examples 39-44, wherein the third shaft is a hypotube comprising one or more openings or slits.

[0343] Example 46. The delivery apparatus of any example herein, particularly any one of examples 39-44, wherein the third shaft is a coil spring.

[0344] Example 47. The delivery apparatus of any example herein, particularly any one of examples 39-44, wherein the third shaft comprises a plurality of interconnected struts forming a lattice structure.

[0345] Example 48. The delivery apparatus of any example herein, particularly any one of examples 39-47, further comprising an activating member configured to move the first shaft between the first position and the second position.

[0346] Example 49. The delivery apparatus of any example herein, particularly example 48, further comprising a handle, wherein the first, second, and third shafts extend distally from the handle, and wherein the activating member is part of the handle.

[0347] Example 50. A method comprising advancing a distal end portion of a rotatable, first shaft of a delivery apparatus from a first position within a rotatable, second shaft of the delivery apparatus to a second position where the distal end portion of the first shaft extends underneath a crimp balloon of the delivery apparatus, wherein the crimp balloon is coupled between a distal end of the first shaft and an inflatable balloon of the delivery apparatus; and after the first shaft is in the second position, rotating the first shaft and the second shaft to rotate a prosthetic valve mounted on a distal end portion of the delivery apparatus in a radially compressed configuration.

[0348] Example 51. The method of any example herein, particularly example 50, wherein in the first position a majority of the distal end portion of the first shaft is located inside the second shaft and away from the crimp balloon.

[0349] Example 52. The method of any example herein, particularly either example 50 or example 51, wherein in the second position the distal end of the first shaft is positioned within a proximal end portion of the inflatable balloon.

[0350] Example 53. The method of any example herein, particularly any one of examples 50-52, wherein the prosthetic valve is mounted on the inflatable balloon in the radially compressed configuration.

[0351] Example 54. The method of any example herein, particularly any one of examples 50-53, further comprising moving the prosthetic valve from a position on the crimp balloon to a position on the inflatable balloon, prior to advancing the distal end portion of the first shaft underneath the crimp balloon.

[0352] Example 55. The method of any example herein, particularly any one of examples 50-54, wherein advancing the distal end portion of the first shaft from the first position to the second position includes actuating an activating member at a proximal end portion of the delivery apparatus to move the first shaft from the first position to the second position.

[0353] Example 56. The method of any example herein, particularly example 55, wherein the activating member is a rotatable knob on a handle of the delivery apparatus.

[0354] Example 57. A delivery apparatus for a prosthetic device, comprising a rotatable shaft comprising a main section having a first diameter; an extension portion extending froma distal end of the main section and having a second diameter that is smaller than the first diameter; a first lumen extending through the main section, with an opening of the first lumen defined in the distal end of the main section; and a second lumen extending through the main section and the extension portion, wherein the second lumen is radially offset from the first lumen and configured to receive a guidewire; and an inflatable balloon arranged around the extension portion, and wherein a proximal end portion of the inflatable balloon is bonded to the distal end of the main section such that the first lumen is fluidly coupled with an interior of the inflatable balloon.

[0355] Example 58. The delivery apparatus of any example herein, particularly example 57, further comprising an outer shaft that surrounds the main section of the rotatable shaft, wherein the outer shaft and the rotatable shaft are axially movable relative to one another.

[0356] Example 59. The delivery apparatus of any example herein, particularly example 58, further comprising a handle, wherein the outer shaft and rotatable shaft extend distally from the handle, and wherein the handle comprises an adjustment mechanism configured to adjust a curvature of a distal end portion of the outer shaft.

[0357] Example 60. The delivery apparatus of any example herein, particularly example 59, wherein a proximal portion of the main section of the rotatable shaft extends proximally from the handle to a connector having two ports.

[0358] Example 61. The delivery apparatus of any example herein, particularly any one of examples 57-60, further comprising a distal tip defining a distal end of the delivery apparatus, wherein the distal tip is coupled to a distal end of the extension portion.

[0359] Example 62. The delivery apparatus of any example herein, particularly example 61, wherein the distal tip is a polymeric tip which is over molded onto the distal end of the extension portion.

[0360] Example 63. The delivery apparatus of any example herein, particularly either example 61 or example 62, wherein the distal tip is a distal shoulder and nose cone.

[0361] Example 64. The delivery apparatus of any example herein, particularly any one of examples 61-63, wherein the distal tip comprises an opening and lumen that is continuous with the second lumen and configured to receive the guidewire.

[0362] Example 65. The delivery apparatus of any example herein, particularly any one of examples 57-64, wherein the extension portion comprises an extruded polymer.

[0363] Example 66. The delivery apparatus of any example herein, particularly any one of examples 57-65, wherein the distal end of the main section comprises a step that is disposed radially inward from the first diameter of the main section, and wherein the proximal end portion of the inflatable balloon is bonded to the step.

[0364] Example 67. An assembly comprising the delivery apparatus of any example herein, particularly any one of examples 57-66, and further comprising a prosthetic valve mounted in a radially collapsed configuration around the proximal end portion of the inflatable balloon and the extension portion of the rotatable shaft.

[0365] Example 68. The assembly of any example herein, particularly example 67, wherein the delivery apparatus further comprises an outer shaft that surrounds and extends along the rotatable shaft, wherein the outer shaft and the rotatable shaft are axially movable relative to one another such that the radially collapsed prosthetic valve is movable from a position around the proximal end portion of the inflatable balloon to a position around an inflatable body of the inflatable balloon, and wherein the delivery apparatus is configured to inflate the inflatable balloon and radially expand the prosthetic valve.

[0366] Example 69. The assembly of any example herein, particularly example 68, wherein the outer shaft is steerable and configured to flex about a central longitudinal axis of the delivery apparatus, and wherein a distal end of the outer shaft comprises a flex tip that is freely rotatable relative to a shaft portion of the outer shaft.

[0367] Example 70. A delivery apparatus for a prosthetic device, comprising a handle; a distal tip; a rotatable shaft comprising a main section with a first lumen and a second lumen that are fluidly separated and radially offset from one another inside the main section, wherein the main section extends distally from the handle; and an extension portion extending from a distal end of the main section to the distal tip, and wherein the second lumen further extends through the extension portion; and an inflatable balloon arranged around the extension portion, and wherein a proximal end portion of the inflatable balloon is bonded to the distal end of the main section such that the first lumen is fluidly coupled with an interior of the inflatable balloon.

[0368] Example 71. The delivery apparatus of any example herein, particularly example 70, wherein the main section has a first outer diameter that is larger than a second outer diameter of the extension portion.

[0369] Example 72. The delivery apparatus of any example herein, particularly either example 70 or example 71, wherein the rotatable shaft comprises a polymer.

[0370] Example 73. The delivery apparatus of any example herein, particularly example 72, wherein the rotatable shaft comprises one or more braided layers embedded within the polymer.

[0371] Example 74. The delivery apparatus of any example herein, particularly any one of examples 70-73, wherein the distal tip is a distal shoulder and a nosecone, and wherein the distal shoulder and nosecone have a lumen that is aligned with the second lumen such that a guidewire can be receive therethrough.

[0372] Example 75. The delivery apparatus of any example herein, particularly any one of examples 70-74, wherein the distal tip is over molded onto a distal end of the extension portion.

[0373] Example 76. The delivery apparatus of any example herein, particularly any one of examples 70-75, further comprising an outer shaft that surrounds the main section of the rotatable shaft, wherein the outer shaft and the rotatable shaft are axially movable relative to one another.

[0374] Example 77. The delivery apparatus of any example herein, particularly example 76, wherein the outer shaft is steerable and configured to flex about a central longitudinal axis of the delivery apparatus.

[0375] Example 78. The delivery apparatus of any example herein, particularly either example 76 or example 77, wherein the outer shaft extends distally from the handle, and wherein the handle comprises an adjustment mechanism configured to adjust a curvature of a distal end portion of the outer shaft.

[0376] Example 79. The delivery apparatus of any example herein, particularly any one of examples 70-79, wherein a proximal portion of the main section of the rotatable shaft extends proximally from the handle to a connector comprising first and second ports that are connected to the first and second lumens, respectively.

[0377] Example 80. The delivery apparatus of any example herein, particularly any one of examples 70-79, wherein the distal end of the main section comprises a step that is disposed radially inward from an outer surface of the main section proximal to the step, and wherein the proximal end portion of the inflatable balloon is bonded to the step.

[0378] Example 81. An assembly comprising the delivery apparatus of any example herein, particularly any one of examples 70-80, and further comprising a prosthetic valve mounted in a radially collapsed configuration around the proximal end portion of the inflatable balloon and the extension portion of the rotatable shaft.

[0379] Example 82. A delivery apparatus for a prosthetic device, comprising a first shaft that is rotatable and has a distal tip comprising a plurality of fingers; a second shaft extending through the first shaft and having a distal end portion extending distally beyond a distal end of the first shaft; and an inflatable balloon arranged around the distal end portion of the second shaft, wherein the distal tip is movable between a first position where the plurality of fingers is spaced radially away from the second shaft and a proximal leg of the inflatable balloon and a second position where the plurality of fingers is arranged against and lock onto the proximal leg of the inflatable balloon.

[0380] Example 83. The delivery apparatus of any example herein, particularly example 82, further comprising a crimp balloon extending from the first shaft to the inflatable balloon, the crimp balloon disposed around the second shaft and within the distal tip of the first shaft.

[0381] Example 84. The delivery apparatus of any example herein, particularly example 83, wherein in the first position, the plurality of fingers is spaced radially away from the crimp balloon and in the second position, the plurality of fingers is arranged adjacent to the crimp balloon.

[0382] Example 85. The delivery apparatus of any example herein, particularly example 84, wherein in the second position, the plurality of fingers contacts the crimp balloon.

[0383] Example 86. The delivery apparatus of any example herein, particularly any one of examples 82-85, further comprising a pull ring arranged around the first shaft, and wherein the pull ring is moveable relative to the first shaft such that the pull ring is arranged around and pushes the plurality of fingers radially inward into the second position.

[0384] Example 87. The delivery apparatus of any example herein, particularly example 86, further comprising a handle, wherein the first and second shafts extend distally from the handle, and wherein the handle is configured to actuate the pull ring into and out of position over the plurality of fingers.

[0385] Example 88. The delivery apparatus of any example herein, particularly example 87, wherein the pull ring is connected to the handle via one or more pull wires.

[0386] Example 89. The delivery apparatus of any example herein, particularly any one of examples 82-85, further comprising a third shaft that is translatable in a direction of a central longitudinal axis of the delivery apparatus, relative to the first shaft.

[0387] Example 90. The delivery apparatus of any example herein, particularly example 89, wherein the third shaft is an outer shaft that is steerable and configured to flex about a central longitudinal axis of the delivery apparatus, and wherein the first shaft is moveable relative to the third shaft such that the plurality of fingers is pulled into an end of the third shaft and move into the second position.

[0388] Example 91. The delivery apparatus of any example herein, particularly example 89, wherein the third shaft is movable over the first shaft such that an end of the third shaft covers the plurality of fingers and moves them into the second position.

[0389] Example 92. The delivery apparatus of any example herein, particularly any one of examples 82-91, wherein the proximal leg comprises a more rigid material than a remainder of the inflatable balloon.

[0390] Example 93. An assembly comprising the delivery apparatus of any example herein, particularly any one of examples 82-92, and further comprising a prosthetic valve mounted in a radially collapsed configuration around the inflatable balloon.

[0391] Example 94. A method comprising moving a distal tip of a rotatable first shaft from a first position where the distal tip is disengaged from a proximal end portion of an inflatable balloon of a delivery apparatus, to a second position where the distal tip is engaged with the proximal end portion of the inflatable balloon, or an extension shaft directly connected to the proximal end portion of the inflatable balloon, wherein the inflatable balloon is mounted around a distal end portion of a second shaft that extends through the first shaft and has a distal end portion extending distally beyond a distal end of the first shaft; and rotating the first shaft, while the distal tip is in the second position, and transferring the rotation to the inflatable balloon such that a prosthetic valve mounted on the inflatable balloon rotates.

[0392] Example 95. The method of any example herein, particularly example 94, wherein the distal tip comprises a plurality of fingers that are configured to flex radially inward and outward relative to a central longitudinal axis of the delivery apparatus, and wherein moving the distal tip from the first position to the second position includes moving free ends of the plurality of fingers radially toward the central longitudinal axis and into engagement with theproximal end portion of the inflatable balloon or the rigid shaft directly connected to the proximal end portion of the inflatable balloon.

[0393] Example 96. The method of any example herein, particularly example 95, wherein moving the free ends of the plurality of fingers into engagement with the proximal end portion of the inflatable balloon or the extension shaft directly connected to the proximal end portion of the inflatable balloon includes moving a pull ring along the distal tip and over the free ends of the plurality of fingers to push the plurality of fingers into engagement with the proximal end portion of the inflatable balloon or the extension shaft directly connected to the proximal end portion of the inflatable balloon.

[0394] Example 97. The method of any example herein, particularly example 96, wherein the pull ring surrounds the first shaft and is disposed within a third shaft that surrounds the first shaft.

[0395] Example 98. The method of any example herein, particularly either example 96 or example 97, wherein the pull ring is connected to one or more pull wires that extend to a handle of the delivery apparatus, and wherein moving the free ends of the plurality of fingers into engagement with the proximal end portion of the inflatable balloon or the extension shaft directly connected to the proximal end portion of the inflatable balloon includes actuating the pull wires to push the pull ring over the free ends of the plurality of fingers.

[0396] Example 99. The method of any example herein, particularly example 95, wherein moving the free ends of the plurality of fingers into engagement with the proximal end portion of the inflatable balloon or the rigid shaft directly connected to the proximal end portion of the inflatable balloon includes moving a third shaft of the delivery apparatus that surrounds the first shaft relative to the first shaft such that a distal end portion of the third shaft extends over the free ends of the plurality of fingers and pushes the plurality of fingers into engagement with the proximal end portion of the inflatable balloon or the rigid shaft directly connected to the proximal end portion of the inflatable balloon.

[0397] Example 100. The method of any example herein, particularly any one of examples 94-99, wherein the first and second shafts extend distally from a handle of the delivery apparatus, and wherein the moving and rotating is actuated by the handle.

[0398] Example 101. A delivery apparatus for a prosthetic device, comprising a first shaft comprising a shaft portion and a distal tip that is coupled to a distal end of the shaft portion such that it is freely rotatable relative to the shaft portion; a second shaft extending throughthe first shaft and having a distal end portion extending distally beyond a distal end of the first shaft; and an inflatable balloon arranged around the distal end portion of the second shaft.

[0399] Example 102. The delivery apparatus of any example herein, particularly example 101, further comprising a rotatable coupling coupled between the distal tip and shaft portion of the first shaft, the rotatable coupling configured to allow the distal tip to freely rotate relative to the shaft portion and the second shaft.

[0400] Example 103. The delivery apparatus of any example herein, particularly either example 101 or example 102, further comprising a handle, wherein the first and second shafts extend distally from the handle, and further comprising an actuating member extending from the handle to the distal tip and configured to rotate the distal tip relative to the shaft portion of the first shaft and the inflatable balloon.

[0401] Example 104. The delivery apparatus of any example herein, particularly example 103, wherein the actuating member is a pull wire.

[0402] Example 105. The delivery apparatus of any example herein, particularly any one of examples 101-104, wherein a distal end of the distal tip comprises mating features configured to mate with an end of a prosthetic valve mounted around the inflatable balloon.

[0403] Example 106. The delivery apparatus of any example herein, particularly example 105, wherein the mating features comprise a plurality of indentations formed in a distal face of the distal tip.

[0404] Example 107. The delivery apparatus of any example herein, particularly any one of examples 101-105, wherein the distal tip is configured to flex outward and compress inward in a radial direction.

[0405] Example 108. The delivery apparatus of any example herein, particularly any one of examples 101-106, further comprising a rotatable third shaft extending through the first shaft and around the second shaft, and wherein the distal end portion of the second shaft extends distally beyond a distal end of the third shaft.

[0406] Example 109. The delivery apparatus of any example herein, particularly example 107, wherein a proximal end portion of the inflatable balloon is coupled directly to the distal end of the third shaft.

[0407] Example 110. The delivery apparatus of any example herein, particularly example 107, wherein a proximal end portion of the inflatable balloon is coupled to the distal end ofthe third shaft through a crimp balloon extending between the inflatable balloon and the third shaft, and wherein the crimp balloon is configured to transfer torque form the third shaft to the inflatable balloon.

[0408] Example 111. The delivery apparatus of any example herein, particularly example 109, further comprising a fourth shaft extending through the third shaft, wherein the fourth shaft is translatable, in a direction of a central longitudinal axis of the delivery apparatus, relative to the second shaft and third shaft such that the fourth shaft is movable between a first position where it is disposed inside the third shaft and away from the crimp balloon and second position where it extends underneath the crimp balloon toward the inflatable balloon.

[0409] Example 112. The delivery apparatus of any example herein, particularly example 109, further comprising a fourth shaft extending through the third shaft and around the second shaft, wherein the fourth shaft extends through the crimp balloon to a proximal end portion of the inflatable balloon.

[0410] Example 113. An assembly comprising the delivery apparatus of any example herein, particularly any one of examples 101-112, and further comprising a prosthetic valve mounted in a radially collapsed configuration around the inflatable balloon.

[0411] Example 114. The assembly of any example herein, particularly example 112, when dependent on claim 105, wherein the mating features are configured to mate with apices of a frame of the prosthetic valve.

[0412] Example 115. The assembly of any example herein, particularly example 114, wherein the mating features comprise teeth.

[0413] Example 116. A method comprising moving, in an axial direction, a radially collapsed prosthetic valve from a position around a crimp balloon of a delivery apparatus to a position around an inflatable body of an inflatable balloon of the delivery apparatus, wherein the crimp balloon extends between a rotatable, first shaft of the delivery apparatus and the inflatable balloon, and wherein the first shaft extends through a second shaft of the delivery apparatus, wherein the first and second shafts are translatable in the axial direction relative to one another, and wherein the second shaft comprises a shaft portion and a distal tip coupled to a distal end of the shaft portion, wherein the distal tip is in contact with the prosthetic when the prosthetic valve is moved onto the inflatable balloon; rotating the first shaft to rotate the inflatable balloon and the prosthetic valve mounted thereon; and during the rotating, freely rotating the distal tip relative to the shaft portion of the second shaft.

[0414] Example 117. The method of any example herein, particularly example 116, wherein moving the radially collapsed prosthetic valve from the crimp balloon to the inflatable body of the inflatable balloon includes translating in the axial direction, the first and second shafts relative to one another to push the prosthetic valve onto the inflatable balloon with the distal tip.

[0415] Example 118. The method of any example herein, particularly either example 116 or example 117, further comprising inflating the inflatable balloon and radially expanding the prosthetic valve at an implantation site.

[0416] Example 119. A method comprising sterilizing the prosthetic heart valve, apparatus, and / or assembly of any example.

[0417] Example 120. A method of treating a heart on a simulation, comprising the method of any example.

[0418] Example 121. A prosthetic heart valve or delivery apparatus of any one of examples 1-120, wherein the prosthetic heart valve is sterilized.

[0419] Example 122. A delivery apparatus for a prosthetic device, comprising: a first shaft; a second shaft extending through the first shaft and having a distal end portion extending distally beyond a distal end of the first shaft; an inflatable balloon arranged around the distal end portion of the second shaft; a crimp balloon at least partially extending between the first shaft and the inflatable balloon, the crimp balloon at least partially disposed around the second shaft; and a rotatable third shaft extending through the first shaft and around the second shaft.

[0420] Example 123. The delivery apparatus of example 122, further comprising a handle, wherein one or more of the first shaft, the second shaft, and the third shaft extends distally from the handle,

[0421] Example 124. The delivery apparatus of example 122 or 123, further comprising any combination of the features of any of examples 2-19.

[0422] Example 125. A delivery apparatus for a prosthetic device, comprising: a rotatable shaft comprising: a main section having a first diameter; an extension portion extending beyond a distal end of the main section and having a second diameter that is smaller than the first diameter; a first lumen extending through the main section, with an opening of the first lumen defined in the distal end of the main section; and a second lumen extending through the main section and the extension portion, wherein the second lumen is radially offset fromthe first lumen; and an inflatable balloon at least partially arranged around the extension portion.

[0423] Example 126. The delivery apparatus of example 125, wherein a proximal end portion of the inflatable balloon is bonded to the distal end of the main section such that the first lumen is fluidly coupled with an interior of the inflatable balloon.

[0424] Example 127. The delivery apparatus of example 125 or 126, further comprising any combination of the features of any of examples 58-69.

[0425] Example 128. A delivery apparatus for a prosthetic device, comprising: a first shaft that is rotatable and has a distal tip comprising a plurality of fingers; a second shaft extending through the first shaft and having a distal end portion extending distally beyond a distal end of the first shaft; and an inflatable balloon arranged around the distal end portion of the second shaft, wherein the distal tip is adjustable between a first configuration where the plurality of fingers is spaced radially away from the second shaft and a proximal leg of the inflatable balloon and a second configuration where the plurality of fingers is arranged against the proximal leg of the inflatable balloon.

[0426] Example 129. The delivery apparatus of example 128, further comprising any combination of the features of any of examples 83-93.

[0427] 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 delivery apparatus can be combined with any one or more features of another delivery apparatus.

[0428] 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.

[0429] 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.

Claims

We claim:

1. A delivery apparatus for a prosthetic device, comprising:a handle;a rotatable first shaft extending distally from the handle;a second shaft extending distally from the handle and through the first shaft and having a distal end portion extending distally beyond a distal end of the first shaft;an inflatable balloon arranged around the distal end portion of the second shaft; a crimp balloon extending from the first shaft to the inflatable balloon, the crimp balloon disposed around the second shaft; anda rotatable third shaft extending distally from the handle and through the first shaft and around the second shaft, wherein the third shaft is configured to extend through the crimp balloon and receive a prosthetic valve in a radially compressed configuration.

2. The delivery apparatus of claim 1, wherein a distal end of the third shaft is coupled to a proximal end portion of the inflatable balloon.

3. The delivery apparatus of claim 1, wherein a distal end of the third shaft is coupled to a distal tip of the delivery apparatus.

4. The delivery apparatus of any one of claims 1-3, wherein the third shaft comprises metal.

5. The delivery apparatus of any one of claims 1-4, wherein the third shaft comprises an array of metal wire.

6. The delivery apparatus of claim 5, wherein the third shaft comprises one or more layers of coiled wire.

7. The delivery apparatus of any one of claims 1-4, wherein the third shaft is a metal hypotube.

8. The delivery apparatus of any one of claims 1-7, wherein there is a gap between the second shaft and the third shaft.

9. An assembly comprising the delivery apparatus of any one of claims 1-8, and further comprising a prosthetic valve mounted in a radially collapsed configuration around the crimp balloon and the third shaft, when the third shaft is arranged underneath the crimp balloon.

10. The assembly of claim 9, wherein the delivery apparatus further comprises a fourth shaft that surrounds and extends along the first shaft, wherein the fourth shaft and the first shaft are axially movable relative to one another such that the radially collapsed prosthetic valve is movable from a position around the crimp balloon to a position around an inflatable body of the inflatable balloon, and wherein the delivery apparatus is configured to inflate the inflatable balloon and radially expand the prosthetic valve.

11. The assembly of claim 10, wherein the fourth shaft is steerable and configured to flex about a central longitudinal axis of the delivery apparatus, and wherein the fourth shaft comprises a distal tip that is freely rotatable relative to a shaft portion of the fourth shaft.

12. A delivery apparatus for a prosthetic device, comprising:a rotatable shaft comprising:a main section having a first diameter;an extension portion extending from a distal end of the main section and having a second diameter that is smaller than the first diameter;a first lumen extending through the main section, with an opening of the first lumen defined in the distal end of the main section; anda second lumen extending through the main section and the extension portion, wherein the second lumen is radially offset from the first lumen and configured to receive a guidewire; andan inflatable balloon arranged around the extension portion, and wherein a proximal end portion of the inflatable balloon is bonded to the distal end of the main section such that the first lumen is fluidly coupled with an interior of the inflatable balloon.

13. The delivery apparatus of claim 12, further comprising an outer shaft that surrounds the main section of the rotatable shaft, wherein the outer shaft and the rotatable shaft are axially movable relative to one another.

14. The delivery apparatus of claim 13, further comprising a handle, wherein the outer shaft and rotatable shaft extend distally from the handle, and wherein the handle comprises an adjustment mechanism configured to adjust a curvature of a distal end portion of the outer shaft.

15. The delivery apparatus of claim 14, wherein a proximal portion of the main section of the rotatable shaft extends proximally from the handle to a connector having two ports.

16. The delivery apparatus of any one of claims 12-15, further comprising a distal tip defining a distal end of the delivery apparatus, wherein the distal tip is coupled to a distal end of the extension portion.

17. The delivery apparatus of any one of claims 12-16, wherein the distal end of the main section comprises a step that is disposed radially inward from the first diameter of the main section, and wherein the proximal end portion of the inflatable balloon is bonded to the step.

18. A delivery apparatus for a prosthetic device, comprising:a first shaft that is rotatable and has a distal tip comprising a plurality of fingers; a second shaft extending through the first shaft and having a distal end portion extending distally beyond a distal end of the first shaft; andan inflatable balloon arranged around the distal end portion of the second shaft, wherein the distal tip is movable between a first position where the plurality of fingers is spaced radially away from the second shaft and a proximal leg of the inflatable balloon and a second position where the plurality of fingers is arranged against and lock onto the proximal leg of the inflatable balloon.

19. The delivery apparatus of claim 18, further comprising a crimp balloon extending from the first shaft to the inflatable balloon, the crimp balloon disposed around the second shaft and within the distal tip of the first shaft.

20. The delivery apparatus of claim 19, wherein in the first position, the plurality of fingers is spaced radially away from the crimp balloon and in the second position, the plurality of fingers is arranged adjacent to the crimp balloon.

21. A delivery apparatus for a prosthetic device, comprising:a rotatable shaft comprising:a main section having a first diameter;an extension portion extending beyond a distal end of the main section and having a second diameter that is smaller than the first diameter;a first lumen extending through the main section, with an opening of the first lumen defined in the distal end of the main section; anda second lumen extending through the main section and the extension portion, wherein the second lumen is radially offset from the first lumen; andan inflatable balloon at least partially arranged around the extension portion.

22. The delivery apparatus of claim 21, wherein a proximal end portion of the inflatable balloon is bonded to the distal end of the main section such that the first lumen is fluidly coupled with an interior of the inflatable balloon.

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