WO2025230908A1 - Delivery apparatus for prosthetic implants - Google Patents

Abstract

A delivery apparatus configured to deliver a prosthetic valve can include a handle, a first and second shaft extending distally from the handle, the second shaft extending through a lumen of the first shaft, and a balloon mounted along the distal end portion of the second shaft. The handle can include an adjustment device, such as a sliding mechanism with a biasing element, for maintaining a crimped prosthetic valve adjacent to the distal end portion of a steerable guide catheter.

Description

DELIVERY APPARATUS FOR PROSTHETIC IMPLANTS

CROSS REFERENCE TO RELATED APPLICATION

[0001] This application claims the benefit of U.S. Provisional Patent Application

No. 63/640,808, filed April 30, 2024, which is incorporated by reference herein in its entirety.

FIELD

[0002] The present disclosure concerns delivery apparatuses, systems, and methods for implantation of a prosthetic implants such as stents and/or prosthetic heart valves.

BACKGROUND

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

SUMMARY

[0004] Described herein are systems and methods for delivering prosthetic devices, such as prosthetic heart valves, through the body and into an implant site, such as the heart, for implantation therein. The disclosed prosthetic heart valves, delivery apparatus, and methods can, for example, provide reduced likelihood of a gap forming between the distal end portion of a guide catheter shaft and the proximal end of a prosthetic device. As such, the devices and methods disclosed herein can, among other things, overcome one or more of the deficiencies of typical prosthetic heart valves and their delivery apparatus. The prosthetic devices delivered with the delivery systems disclosed herein are, for example, radially expandable from a radially compressed state mounted on the delivery system to a radially expanded state for implantation using an inflatable balloon (or equivalent expansion device) of the delivery system. Exemplary delivery routes through the body and into the heart include transfemoral routes, transseptal routes, transapical routes, and transaortic routes, among others. Although the devices and methods disclosed herein are particularly suited for implanting prosthetic heart valves (for example, a prosthetic aortic valve or prosthetic mitral valve), the disclosed devices and methods can be adapted for implanting other types of prosthetic valves within the body (for example, prosthetic venous valves) or other types of expandable prosthetic devices adapted to be implanted in various body lumens.

[0005] In one aspect, a delivery apparatus for a prosthetic implant can comprise a handle and one or more shafts coupled to the handle. In addition to these components, a delivery apparatus can further comprise one or more of the components disclosed herein.

[0006] In some examples, the delivery apparatus comprises: a first shaft having a proximal end portion and a distal end portion; a second shaft, wherein the second shaft extends coaxially over the first shaft; and a handle assembly comprising: a first slider element wherein the first slider element comprises a threaded distal portion and an unthreaded proximal portion, a second slider element, wherein the second slider element comprises a distal end portion defining a lumen and the unthreaded proximal portion of the first slider element extends into the lumen of the second slider element, and a biasing element disposed around the unthreaded portion of the first slider element and having a proximal end which abuts the distal end portion of the second slider element and a distal end that abuts the threaded portion of the first slider element, wherein the second shaft extends from the handle assembly and the second shaft is movable between a first flex configuration and a second flex configuration, wherein the second slider element is coupled to the first shaft, wherein movement of the second shaft from the first flex configuration to the second flex configuration results in expansion of the biasing element and relative axial motion between the first and second slider elements.

[0007] In some examples, the delivery apparatus comprises a second slider apparatus which is selectively coupled to the first shaft.

[0008] In some examples, the delivery apparatus includes a biasing element which comprises one or more coil springs. [0009] In some examples, an inflatable balloon is disposed on the distal end portion of the first shaft. In some examples, the delivery apparatus is a part of an assembly further comprising an expandable medical implant in a radially compressed state. In some examples, the expandable implant is disposed around the inflatable balloon. In some examples, the implant comprises a prosthetic heart valve.

[0010] In some examples, the deliver apparatus can be used in a method of implanting a medical implant, comprising: moving one or more biasing elements within a slider assembly from the expanded state to the compressed state by moving a second shaft of a delivery apparatus relative to a first shaft of the delivery apparatus; introducing a delivery apparatus into a patient’s body; and adjusting tension in a pull wire of the delivery apparatus, wherein adjusting the tension in the pull wire results in the one or more biasing elements of the delivery apparatus expanding from a compressed state to an expanded state to maintain a distal end portion of a second shaft in contact with a proximal end of a medical implant which is disposed at the end of the first shaft.

[0011] The above method can be performed on a living animal or on a simulation, such as on a cadaver, cadaver heart, anthropomorphic ghost, simulator (for example, with body parts, heart, tissue, etc. being simulated).

[0012] 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

[0013] FIG. 1 is a side view of a portion of a delivery apparatus for implanting a prosthetic heart valve, according to one example.

[0014] FIG. 2 is a cross-sectional view of the handle portion of the delivery apparatus of FIG. 1 in a neutral state.

[0015] FIG. 3 is a cross-sectional view of the handle portion of the delivery apparatus of FIG. 1 in a state where distal tension is applied. [0016] FIG. 4 is a cross-sectional view of the handle portion of the delivery apparatus of FIG. 1 in a state where flex is applied to the steerable section of the guide catheter.

[0017] FIG. 5 is a perspective view of the slider of the delivery apparatus of FIG. 1 in a relaxed position.

[0018] FIG. 6 is a perspective view of the slider of the delivery apparatus of FIG. 1 in a compressed position.

[0019] FIGS. 7A-7B schematically depict the in vivo positions of the steerable section of the guide catheter as the delivery apparatus of FIG. 1 traverses the patient’s vasculature.

[0020] FIG. 8 depicts an example of a prosthetic heart valve that can be implanted using any of the delivery apparatuses disclosed herein.

DETAILED DESCRIPTION

General Considerations

[0021] Described herein are examples of a delivery apparatus (sometimes referred to as a delivery catheter) that can be used to navigate a subject’s vasculature to deliver an implantable, expandable medical device (for example, a prosthetic heart valve), tools, agents, or other therapy to a location within the body of a subject. Examples of procedures in which the steerable catheters are useful include neurological, urological, gynecological, fertility (for example, in vitro fertilization, artificial insemination), laparoscopic, arthroscopic, transesophageal, transvaginal, transvesical, transrectal, and procedures including access in any body duct or cavity. Particular examples include placing implants, including stents, grafts, embolic coils, and the like; positioning imaging devices and/or components thereof, including ultrasound transducers; and positioning energy sources, for example, for performing lithotripsy, RF sources, ultrasound emitters, electromagnetic sources, laser sources, thermal sources, and the like.

[0022] It should be understood that the disclosed examples can be adapted to deliver and implant prosthetic devices in any of the native annuluses of the heart (for example, the pulmonary, mitral, and tricuspid annuluses), and can be used with any of various delivery approaches (for example, retrograde, antegrade, transseptal, transventricular, transatrial, etc.). [0023] For purposes of this description, certain aspects, advantages, and novel features of the examples of this disclosure are described herein. The disclosed methods, apparatus, and systems should not be construed as being limiting in any way. Instead, the present disclosure is directed toward all novel and nonobvious features and aspects of the various disclosed examples, alone and in various combinations and sub-combinations with one another. The methods, apparatus, and systems are not limited to any specific aspect or feature or combination thereof, nor do the disclosed examples require that any one or more specific advantages be present or problems be solved. The technologies from any example can be combined with the technologies described in any one or more of the other examples. In view of the many possible examples to which the principles of the disclosed technology may be applied, it should be recognized that the illustrated examples are only preferred examples and should not be taken as limiting the scope of the disclosed technology.

[0024] 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.

[0025] As used in this application and in the claims, the singular forms “a,” “an,” and “the” include the plural forms unless the context clearly dictates otherwise. Additionally, the term “includes” means “comprises.” Further, the terms “coupled” and “connected” generally mean electrically, electromagnetically, and/or physically (for example, mechanically or chemically) coupled or linked and does not exclude the presence of intermediate elements between the coupled or associated items absent specific contrary language.

[0026] As used herein, the term “proximal” refers to a position, direction, or portion of a device that is closer to the user and further away from the implantation site. As used herein, the term “distal” refers to a position, direction, or portion of a device that is further away from the user and closer to the implantation site. Thus, for example, proximal motion of a device is motion of the device away from the implantation site and toward the user (for example, out of the patient’s body), while distal motion of the device is motion of the device away from the user and toward the implantation site (for example, into the patient’s body). The terms “longitudinal” and “axial” refer to an axis extending in the proximal and distal directions, unless otherwise expressly defined.

[0027] As described herein, the term “inflow” can generally refer to a position, direction, or portion of the prosthetic heart valve that is closer to an inlet into which blood flow enters the prosthetic heart valve. As described herein, the term “outflow” can generally refer to a position, direction, or portion of a prosthetic heart valve that is closer to an outlet from which blood flow exits the prosthetic heart valve.

[0028] As described herein, the term “adjacent” can generally refer to components which are next to or adjoining one another. Unless otherwise expressly defined, adjacent can be understood to mean within 3 mm.

[0029] Directions and other relative references (for example, inner, outer, upper, lower, etc.) may be used to facilitate discussion of the drawings and principles herein but are not intended to be limiting. For example, certain terms may be used such as “inside,” “outside,”, “top,” “down,” “interior,” “exterior,” and the like. Such terms are used, where applicable, to provide some clarity of description when dealing with relative relationships, particularly with respect to the illustrated examples. Such terms are not, however, intended to imply absolute relationships, positions, and/or orientations. For example, with respect to an object, an “upper” part can become a “lower” part simply by turning the object over. Nevertheless, it is still the same part and the object remains the same. As used herein, “and/or” means “and” or “or,” as well as “and” and “or.”

Overview of an Exemplary Delivery Apparatus for Implanting a Prosthetic Valve [0030] A delivery apparatus for implanting a prosthetic device (e.g., a transcatheter heart valve or a stent) via a patient’s vasculature can include an adjustment device for maintaining a crimped prosthetic device adjacent to the distal end portion of a steerable guide catheter. A balloon catheter can extend through a guide catheter (also referred to as a “flex catheter” and/or a “steerable catheter”), and a balloon at a distal end of the balloon catheter can be positioned proximal or distal to a crimped prosthetic device. The balloon and the crimped prosthetic device can enter the vasculature of a patient through an introducer sheath and, once the balloon and the crimped prosthetic device reach a suitable location in the body, the prosthetic device eventually can be expanded at the treatment site. The prosthetic device is advanced to the vicinity of the deployment location (for example, at the native aortic valve) and the adjustment device can further be used to position the prosthetic device relative to the desired deployment location.

[0031] The delivery apparatuses disclosed herein can, for example, keep the distal end of the guide catheter and the proximal end of the prosthetic device in close proximity. Maintaining the distal end of the guide catheter against or in close proximity to the proximal end of the prosthetic device can provide one or more advantages such as preventing the prosthetic device from moving relative to the balloon and enabling the prosthetic device to pass with less friction through the patient’ s vasculature.

[0032] FIG. 1 shows a delivery apparatus 10, according to one example, that can be used to implant a medical implant, such as an expandable prosthetic heart valve 12, (e.g., prosthetic valve 400 of FIG. 8), or another type of expandable prosthetic medical device (such as a stent). In some embodiments, the delivery apparatus 10 is specifically adapted for use in introducing a prosthetic valve into a heart. The delivery apparatus 10 is a balloon catheter comprising a handle 20 and a steerable, guide catheter shaft 22 (also referred to as a “second shaft,” “outer shaft,” and/or “steerable shaft”) extending distally from the handle 20. The delivery apparatus 10 can further comprise an intermediate shaft 26 (which also may be referred to as a “first shaft” and/or a “balloon shaft”) that extends proximally from the handle 20 and distally from the handle 20, the portion extending distally from the handle 20 also extending coaxially through the guide catheter shaft 22.

[0033] The handle 20 can include a steering mechanism configured to adjust the curvature of the steerable section 68 (e.g., see FIGS. 7A-7B) of the delivery apparatus 10. The curvature of the steerable section 68 can be adjusted by an operator to assist in guiding the delivery apparatus 10 through the patient’s vasculature, and in particular, the aortic arch. The steerable section 68 of the guide catheter shaft 22 comprises an actuation element 72 (also called a “pull wire”) which has its distal end at the distal end of the steerable section 68. The proximal end of the actuation element 72 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 74 (e.g., see FIG. 2-4). The handle 20 includes an adjustment member, such as the illustrated rotatable knob 70, which in turn is operatively coupled to the slide nut 74. Stated differently, the actuation element 72 can extend distally from the handle 20 through the guide catheter shaft 22 and have its distal end portion affixed to the guide catheter shaft 22 at or near the distal end of the guide catheter shaft 22. Rotating the knob 70 moves the slide nut 74 axially and increases or decreases the tension in the actuation element 72, thereby adjusting the curvature of the steerable section 68 of the delivery apparatus 10. Further details on steering or flex mechanisms for the delivery apparatus can be found in U.S. Patent No. 9,339,384 and in International Publication No. WO 2022/046585, which are incorporated by reference herein.

[0034] In some examples, the steerable section 68 in its non-deflected shape is slightly curved and in its fully curved position, the steerable section 68 generally conforms to the shape of the aortic arch. In some examples, the steerable section 68 can be substantially straight in its non-deflected position.

[0035] To implant a prosthetic valve (for example, prosthetic valve 12) in a native heart valve of the patient, the delivery apparatus 10 can be introduced into a vasculature of the patient. As the prosthetic valve 12 is guided through the aortic arch and into the ascending aorta, the curvature of the steerable section 68 can be adjusted to help guide or steer the prosthetic valve 12 through that portion of the vasculature. When navigating the prosthetic valve 12 through an arched region of the vasculature (for example, the aortic arch), the curvature of the steerable section 68 can be adjusted as discussed above, for example, by rotating the knob 70 to tension the actuation element 72.

[0036] The handle 20 can further include an adjustment mechanism 30 including an adjustment member, such as the illustrated rotatable knob 32, and a shaft 34 extending distally into a housing 36 of the handle 20. The adjustment mechanism 30 is configured to adjust the axial position of the intermediate shaft 26 relative to the guide catheter shaft 22 (e.g., see FIGS. 1-4). In some embodiments, as shown in FIG. 2-4, an inner support 38 is mounted within the housing 36 on the intermediate shaft 26 and an inner shaft 40 (also referred to as a “slider’- or “sliding mechanism”) is mounted on the inner support 38. The inner shaft 40 can be coupled to the inner support 38 such that rotation of shaft 34 causes the inner shaft 40 to move axially within the handle 20.

[0037] As depicted in FIG. 5-6, the inner shaft 40 comprises a first slider element 46 (also referred to as a “slider drive portion”), a biasing element 48, and a second slider element 50 (also referred to as a “slider lock portion”). In the depicted example, the first element and second element have circular cross-sections and are substantially cylindrical. In some examples, the first and second element may have cross-sections which are square, hexagonal, or another suitable shape. In the depicted example, the first element 46 and second element 50 have the same cross-sectional shape, in some examples they may have cross-sectional shapes which are different.

[0038] In the depicted example, the first element 46 has a distal end portion 42 formed with external threads that mate with internal threads that extend along the inner surface of the shaft 34 (e.g., see FIG. 2). The first element 46 also has a proximal end portion 47 which has an outer diameter sized to fit within the inner diameter of the second element 50. In the depicted example, the distal end portion 42 has a larger radius than the proximal end portion 47. As will be discussed below, the first element 46 may comprise a mechanism on the proximal end of the second element 50 for interfacing with the second element 50 and capturing the first element 46 within the second element 50. In the depicted example this mechanism comprises one or more tabs 52; however, in other examples, it could comprise a protrusion, bump, or other similar mechanism.

[0039] One or more biasing elements may provide an axial bias between the first element 46 and the second element 50. Described another way, the one or more biasing elements provide a force on the first element 46 and the second element 50 in opposite directions along a common axis, this is further discussed below. The one or more biasing elements may be disposed around the proximal end portion 47 of the first element 46. In the depicted example, there is one biasing element 48 and the distal end of the biasing element 48 abuts the proximal end of the first element 46 distal end portion 42 and the proximal end of the biasing element 48 abuts the distal end of the second element 50. The one or more biasing elements can be springs such as a coil compression springs. In some examples, the spring can comprise stainless steel, nitinol, and/or other materials with similar elastic properties. In some examples, a plurality of compression springs can be used. The various springs can comprise the same or different spring rates. In some examples, the one or more biasing elements can comprise another type of elastic device that is biased to an axially expanded configuration and that can be moved to an axially compressed state. In some examples, one or more compression springs and/or one or more other biasing elements can be used.

[0040] In the depicted example, the second element 50 comprises a section 58 with an inner bore (also referred to as a “lumen”) which is sized and shaped to receive the proximal end portion 47 of the first element 46. As will be discussed further below, the second element 50 may comprise one or more windows 54 to capture corresponding mechanisms on the first element 46, for example the tab 52. The second element 50 may also comprise one or more slits 56 which allow a portion of the second element 50 to bend and/or flex radially outward in order to insert the first element 46 and its tab 52 into the lumen of the second element 50. Additionally (or alternatively), the first element 46 can comprise slits, for example, on either side of the tab 52. This would allow a portion of the first element 46 to bend and/or flex radially inward in order to allow for the insertion of the first element 46 into the lumen of the second element 50.

[0041] As introduced above, the first element 46 may have a mechanism for interfacing with the second element 50 and ensuring the proximal end portion 47 remains captured within the second element 50. This mechanism can comprise one or more tabs 52 which are captured by one or more corresponding windows 54 in the second element 50. In the depicted example, the proximal end portion 47 of the first element 46 comprises a tab 52. The tab 52 is sized and positioned to fit within corresponding window 54 in the second element 50. In some examples, the proximal end portion 47 of the first element 46 comprises a second tab and the second element 50 comprises a second corresponding window which are positioned on the radially opposite side of the inner shaft 40. In some examples, the first element 46 can comprise more than two tabs and the second element 50 can comprise more than two corresponding windows (for example three to four tab and window pairs). In some examples, the second element 50 can comprise one or more tabs which extend into the lumen of the second element 50 and the first element 46 can comprise one or more corresponding windows. Any of the methods of capture described above have the advantages of preventing the first element 46 from rotating relative to the second element 50 and preventing the first element 46 from separating from the second element 50 in the axial direction.

[0042] As depicted in FIG. 2-4, the second element 50 of the inner shaft 40 further includes a proximal end portion 44 that mounts and interfaces with a locking mechanism 60, which is configured to retain (also referred to as “selectively couple” and/or “lock”) the position of the intermediate shaft 26 relative to the handle 20. The locking mechanism 60 can include another adjustment member, configured as a rotatable knob 62 housing an inner nut 64 with inner threads that engage the external threads of the proximal end portion 44 of the inner shaft 40.

[0043] To restrain movement of the intermediate shaft 26 for fine positioning of the prosthetic valve mounted on the distal end portion of the delivery apparatus 10, the knob 62 is rotated, which in turn causes rotation of the inner nut 64. As a result, the inner nut 64 translates in the distal direction along the external threads on the proximal end portion 44 of the inner shaft 40. As the nut 64 is moved distally, additional components of the locking mechanism 60 are configured to frictionally engage the intermediate shaft 26, thereby retaining the intermediate shaft 26 relative to the inner shaft 40. In the locked position, for example, rotation of the knob 32 causes the inner shaft 40 and the intermediate shaft 26 to move axially relative to the guide catheter shaft 22 (either in the proximal or distal direction, depending on the direction the knob 32 is rotated).

[0044] Rotating the knob 62 in the opposite direction from the locked position to the unlocked position allows axial and rotational movement of the intermediate shaft 26 relative to the inner shaft 40 and the proximal end portion of the handle 20. Further details on the adjustment mechanism 30 and locking mechanism 60 of the handle 20 can be found in U.S. Patent No. 9,339,384.

[0045] Flexing the steerable section 68 of the guide catheter shaft 22 to adjust the curvature can, in some instances, result in the guide catheter shaft 22 axially foreshortening relative to the intermediate shaft 26. The delivery apparatus 10, and more specifically the inner shaft 40, comprises features to compensate for the foreshortening. These features can, for example, keep the distal end of the guide catheter shaft 22 and the proximal end of the prosthetic valve 12 in close proximity so that there is no gap or a minimal gap there between. Maintaining a distal end portion 66 of the guide catheter shaft 22 against or in close proximity to the proximal end of the prosthetic valve 12 can provide one or more advantages. For example, it can prevent the valve from moving proximally relative to the balloon. Additionally (or alternatively), it can provide a relatively smooth transition from the prosthetic valve to the guide catheter shaft, which enables it to pass with less friction through the patient’s vasculature.

[0046] FIGS. 2-4 depict examples of steps in the operation of the handle 20 of the delivery apparatus 10. In FIG. 2, the handle 20 is in a preliminary, neutral state. In the neutral state, the locking mechanism 60 may be in the locked position or unlocked position, no flex is applied to the guide catheter shaft 22 which is depicted by the slide nut 74 being positioned in the distal most position, and the distal end portion 66 of the guide catheter shaft 22 is not abutting the proximal end of the valve 12.

[0047] In FIG. 3, the locking mechanism 60 is in the locked position which means that the second element 50 of the inner shaft 40 and the intermediate shaft 26 are axially fixed relative to one another. The knob 32 has been adjusted to translate the first element 46 of the inner shaft 40 in the proximal direction, this translation causes the intermediate shaft 26 to move proximally relative to the guide shaft 22 and the distal end portion 66 of the guide catheter shaft 22 abuts the proximal end of the valve 12 (e.g., see FIG. 7A). Once the distal end portion 66 of the guide catheter shaft 22 abuts the proximal end of the valve 12, the second element 50 of the inner shaft 40 and the intermediate shaft 26 cease to move in the proximal direction and further adjustment of the knob 32 translates the first element 46 of the inner shaft 40 in the proximal direction relative to the second element 50. This motion of the first element 46 relative to the second element 50 applies an axially compressive force to the biasing element 48 and causes the biasing element 48 to compress. No flex has been applied to the steerable section 68 of the guide catheter shaft 22 which is depicted by the slide nut 74 being positioned in the distal most position. In some examples, this step may be carried out during a pre-operation preparation phase, before the delivery apparatus 10 is inserted into the patient’s vasculature.

[0048] In FIG. 4, the locking mechanism 60 remains in the locked position and flex has been applied the steerable section 68 of the guide catheter shaft 22 by rotating the knob 70. The rotation of the knob 70 results in proximal movement of the slid nut 74 and increased tension in the pull actuation element 72. As mentioned above, this flexing of the steerable section 68 may cause the guide catheter shaft 22 to axially foreshorten relative to the intermediate shaft 26. As the guide catheter shaft 22 axially foreshortens relative to the intermediate shaft 26, the second element 50 is moved proximal by the biasing element 48. Stated another way, as the guide catheter 22 axially foreshortens, compression in the biasing element 48 relaxes, causing the second element 50 to move proximally. Because the second element 50 is fixed relative to the intermediate shaft 26, the intermediate shaft 26 moves relative to the guide shaft 22 and the distal end portion 66 of the guide catheter shaft 22 remains abutting, and/or adjacent to, the proximal end of the valve 12 (e.g., see FIG. 7B).

[0049] FIGS. 7A-7B schematically depict the in vivo positions of the distal end portion 66 of the guide catheter shaft 22 as the delivery apparatus 10 traverses the patient’s vasculature on the way to the aortic annulus 90. As shown in FIG. 7A, as the distal end portion of the delivery apparatus 10 is traversed through the patient’s vasculature the distal end portion 66 of the guide catheter shaft 22 abuts the proximal end of the valve 12. As shown in FIG. 7B, the steerable section 68 is flexed around the aortic arch and, as described above, compression in the biasing element 48 relaxes and maintains the distal end portion 66 of the guide catheter shaft 22 adjacent to the proximal end of the valve 12. As depicted in FIG. 7B, in the absence of the compensation caused by the features of the delivery apparatus 10, and more specifically the inner shaft 40, a gap may form between the distal end portion 66 of the guide catheter shaft 22 and the proximal end of the valve 12. This gap is depicted in FIG. 7B by the dotted line 67, which shows the estimated position of the proximal end of the valve 12 relative to the distal end portion 66 of the guide catheter shaft 22 in the absence of the compensation as discussed above.

[0050] After the valve 12 has been navigated to the aortic annulus, additional steps can be taken to position the valve 12. For example, the locking mechanism 60 can be placed in the unlocked position and the guide catheter shaft 22 can be retracted relative to the intermediate shaft 26. This means that the distal end portion 66 of the guide catheter shaft 22 no longer abuts or is adjacent to the proximal end of the valve 12. The locking mechanism 60 can then be placed back in the locked position and the knob 32 can be rotated to cause the intermediate shaft 26 to move axially relative to the guide catheter shaft 22 and allow the user to position the valve 12 relative to the desired deployment location as described above. Additional information regarding positioning and/or expanding the prosthetic valve 12 can be found in U.S. Patent No. 9,339,384 and in International Publication No. WO 2022/046585.

[0051] The operation of the inner shaft 40, as discussed above, keeps the distal end of the guide catheter shaft 22 and the proximal end of the prosthetic valve 12 in close proximity so that no gap (or a minimal gap) forms as the delivery apparatus 10 traverses the patient’s vasculature on the way to the aortic annulus 90. Maintaining the distal end portion 66 of the guide catheter shaft 22 against or in close proximity to the proximal end of the prosthetic valve 12 can prevent the valve from moving proximally relative to the balloon. Additionally (or alternatively), it can provide a relatively smooth transition from the prosthetic valve to the guide catheter shaft, which enables it to pass with less friction through the patient’ s vasculature. Furthermore, this device retains the functionality of adjusting the axial position of the balloon catheter shaft 26 relative to the guide catheter shaft 22 to position the prosthetic device relative to the desired deployment location. For example, a user can rotate the knob 32 with the locking mechanism 60 in the locked position and/or axially move the intermediate shaft 26 relative to the guide catheter shaft 22 with the locking mechanism 60 in the unlocked position. [0052] FIG. 8 shows a prosthetic heart valve 400, which can be one specific example of the prosthetic valve 12 described above. As shown, the heart valve 400 comprises an annular frame, or stent, 402 and a leaflet structure 404 supported by the frame. In some examples, the prosthetic heart valve 400 is adapted to be implanted in the native aortic valve and can be implanted in the body using, for example, the delivery apparatus 10 described above. The prosthetic valve 400 can also be implanted within the body using any of the other delivery apparatuses described herein.

[0053] In some examples, the frame 402 comprises a plastically expandable material, which can be 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 402 can comprise stainless steel. In some examples, the frame 402 can comprise cobalt-chromium. In some examples, the frame 402 can comprise nickel-cobalt-chromium. In some examples, the frame 402 comprises a nickel- cobalt-chromium-molybdenum alloy, such as MP35N™ (tradename of SPS Technologies), which is equivalent to UNS R3OO35 (covered by ASTM F562-02). MP35N™/UNS R3OO35 comprises 35% nickel, 35% cobalt, 20% chromium, and 10% molybdenum, by weight. Sterilization

[0054] Any of the systems, devices, apparatuses, etc. herein can be sterilized (for example, with heat/thermal, pressure, steam, radiation, and/or chemicals, etc.) to ensure they are safe for use with patients, and any of the methods herein can include sterilization of the associated system, device, apparatus, etc. as one of the steps of the method. Examples of heat/thermal sterilization include steam sterilization and autoclaving. Examples of radiation for use in sterilization include, without limitation, gamma radiation, ultra-violet radiation, and electron beam. Examples of chemicals for use in sterilization include, without limitation, ethylene oxide, hydrogen peroxide, peracetic acid, formaldehyde, and glutaraldehyde. Sterilization with hydrogen peroxide may be accomplished using hydrogen peroxide plasma, for example. Delivery Techniques

[0055] 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 (e.g., by inflating a balloon, actuating one or more actuators of the delivery apparatus, or deploying the prosthetic valve from a sheath to allow the prosthetic valve to self-expand). Alternatively, a prosthetic valve can be implanted within the native aortic valve in a transapical procedure, whereby the prosthetic valve (on the distal end portion of the delivery apparatus) is introduced into the left ventricle through a surgical opening in the chest and the apex of the heart and the prosthetic valve is positioned within the native aortic valve. Alternatively, in a transaortic procedure, a prosthetic valve (on the distal end portion of the delivery apparatus) is introduced into the aorta through a surgical incision in the ascending aorta, such as through a partial J- stemotomy or right parasternal mini- thoracotomy, and then advanced through the ascending aorta toward the native aortic valve.

[0056] For implanting a prosthetic valve within the native mitral valve via a transseptal delivery approach, the prosthetic valve is mounted in a radially compressed state along the distal end portion of a delivery apparatus. The prosthetic valve and the distal end portion of the delivery apparatus are inserted into a femoral vein and are advanced into and through the inferior vena cava, into the right atrium, across the atrial septum (through a puncture made in the atrial septum), into the left atrium, and toward the native mitral valve. Alternatively, a prosthetic valve can be implanted within the native mitral valve in a transapical procedure, whereby the prosthetic valve (on the distal end portion of the delivery apparatus) is introduced into the left ventricle through a surgical opening in the chest and the apex of the heart and the prosthetic valve is positioned within the native mitral valve.

[0057] 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.

[0058] 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. A trial delivery can also be made intravascularly, such as from a pulmonary vein. Still another delivery approach is a transventricular approach whereby a prosthetic valve (on the distal end portion of the delivery apparatus) is inserted through an incision in the chest and an incision made through the wall of the right ventricle (typically at or near the base of the heart) for implanting the prosthetic valve within the native tricuspid valve, the native pulmonary valve, or the pulmonary artery.

[0059] In all delivery approaches, the delivery apparatus can be advanced over a guidewire previously inserted into a patient’s vasculature. Moreover, the disclosed delivery approaches are not intended to be limited. Any of the prosthetic valves disclosed herein can be implanted using any of various delivery procedures and delivery devices known in the art.

[0060] 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 (e.g., with the body parts, tissue, etc. being simulated), etc.

Additional Examples of the Disclosed Technology

[0061] 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.

[0062] Example 1. A delivery apparatus for delivering a medical implant to an implantation location within a patient’s body, the delivery apparatus comprising: a first shaft having a proximal end portion and a distal end portion; a second shaft, wherein the second shaft extends over the first shaft; and a handle assembly comprising: a first slider element wherein the first slider element comprises a threaded distal portion and an unthreaded proximal portion; a second slider element, wherein the second slider element comprises a distal end portion defining a lumen and the unthreaded proximal portion of the first slider element extends into the lumen of the second slider element; and a biasing element disposed around the unthreaded proximal portion of the first slider element and having a proximal end which abuts the distal end portion of the second slider element and a distal end that abuts the threaded distal portion of the first slider element, wherein the second shaft extends from the handle assembly and the second shaft is movable between a first flex configuration and a second flex configuration, wherein the second slider element is coupled to the first shaft, and wherein movement of the second shaft from the first flex configuration to the second flex configuration results in expansion of the biasing element and relative axial motion between the first and second slider elements.

[0063] Example 2. The delivery apparatus of any example herein, particularly example 1, wherein the second slider element is selectively coupled to the first shaft.

[0064] Example 3. The delivery apparatus of any example herein, particularly either of example 1 or example 2, wherein the biasing element comprises one or more coil compression springs.

[0065] Example 4. The delivery apparatus of any example herein, particularly any one of examples 1-3, wherein the first flex configuration is an unflexed configuration.

[0066] Example 5. The delivery apparatus of any example herein, particularly any one of examples 1-4, further comprising an inflatable balloon disposed on the distal end portion of the first shaft.

[0067] Example 6. An assembly comprising the delivery apparatus of any example herein, particularly example 5, and further comprising an expandable medical implant in a radially compressed state.

[0068] Example 7. The assembly of any example herein, particularly example 6, wherein the expandable medical implant is disposed around the inflatable balloon.

[0069] Example 8. The assembly of any example herein, particularly either of example 6 or example 7, wherein the implant comprises a prosthetic heart valve.

[0070] Example 9. The assembly of any example herein, particularly example 8, wherein the prosthetic heart valve comprises an annular frame and a plurality of leaflets disposed in the frame.

[0071] Example 10. An assembly for delivering a medical implant to an implantation location within a patient’s body, the assembly comprising: an expandable medical implant in an unexpanded state; and a delivery apparatus configured for implanting a medical implant, comprising: a first shaft having a proximal end portion and a distal end portion, the distal end portion comprising an inflatable balloon; wherein the medical implant is disposed around the inflatable balloon; a second shaft, wherein the second shaft extends coaxially over the first shaft, and the second shaft has a distal end which is movable between a first flex configuration and a second flex configuration; and a handle assembly comprising: an knob comprising inner threads; a first slider element comprising a threaded portion at a distal end and an unthreaded portion wherein the threaded portion is rotatably coupled to the inner threads of the knob; a second slider element comprising a bore wherein the unthreaded portion of the first slider element is sized and shaped to fit within the bore of the second slider element; and a biasing element disposed around the unthreaded portion of the first slider element and having a proximal end which abuts an end portion of the second slider element and a distal end that abuts the threaded portion of the first slider element, wherein the second slider element is coupled to the first shaft, wherein rotation of the knob results in relative motion between the first and second shafts, and wherein movement of the second shaft from the first flex configuration to the second flex configuration results in expansion of the biasing element and the proximal end of the expandable medical implant remaining adjacent to the distal end portion of the second shaft.

[0072] Example 11. The assembly of any example herein, particularly example 10, wherein the second slider element is selectively coupled to the first shaft.

[0073] Example 12. The assembly of any example herein, particularly any one of examples 10-11, wherein the biasing element comprises one or more coil compression springs.

[0074] Example 13. The delivery apparatus of any example herein, particularly any one of examples 10-12, wherein the movement of the second shaft from the first Hex configuration to the second flex configuration results in more flex applied to the second shaft.

[0075] Example 14. The assembly of any example herein, particularly any one of examples 10-13, wherein the implant comprises a prosthetic heart valve.

[0076] Example 15. The assembly of any example herein, particularly example 14, wherein the prosthetic heart valve comprises an annular frame and a plurality of leaflets disposed in the frame.

[0077] Example 16. A handle for a prosthetic implant delivery apparatus, comprising: a first slider element comprising a threaded portion at a distal end and an unthreaded portion, wherein the unthreaded portion defines an outer diameter and the threaded portion extends radially outward from the unthreaded portion outer diameter; a second slider element, comprising a bore defining an inner diameter wherein the unthreaded portion outer diameter of the first slider element is sized and shaped to fit within the inner diameter of the second slider element; and one or more biasing elements disposed around the first slider element and having a proximal end which abuts an end portion of the second slider element and a distal end that abuts the threaded portion of the first slider element, wherein the one or more biasing elements provide axial bias between the first slider element and the second slider element.

[0078] Example 17. The assembly of any example herein, particularly any one of examples 10-11, wherein the biasing element comprises one or more coil springs.

[0079] Example 18. The delivery apparatus or assembly of any example herein, particularly any one of examples 1-17, wherein the delivery apparatus or assembly is sterilized.

[0080] Example 19. A method of implanting a medical implant, comprising: moving one or more biasing elements within a slider assembly from an expanded state to a compressed state by moving a second shaft of a delivery apparatus relative to a first shaft of the delivery apparatus; introducing a delivery apparatus into a patient’s body; and adjusting tension in a pull wire of the delivery apparatus, wherein adjusting the tension in the pull wire results in the one or more biasing elements of the delivery apparatus expanding from a compressed state to an expanded state to maintain a distal end portion of a second shaft in contact with a proximal end of a medical implant which is disposed at the end of the first shaft.

[0081] Example 20. The method of any example herein, particularly example 19, further comprising advancing a distal end portion of the delivery apparatus towards an implant location until the medical implant is within or adjacent to the desired implant position.

[0082] Example 21. The method of any example herein, particularly either of example 19 or example 20, further comprising inflating a balloon, wherein inflating the balloon results in radial expansion of the medical implant.

[0083] Example 22. The method of any example herein, particularly any one of examples 19-21, wherein the medical implant is a prosthetic heart valve, and the method further comprises advancing the distal end portion of the delivery apparatus through the patient’ s aorta until the medical implant is within or adjacent to the patient’s native aortic valve.

[0084] Example 23. The method of any example herein, particularly any one of examples 19-22, wherein the method is performed on a living animal or on a simulation.

[0085] 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 locking mechanism can be combined with any one or more features of another locking mechanism. As another example, any one or more features of one delivery apparatus can be combined with any one or more features of another delivery apparatus.

[0086] 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

CLAIMS:

1. A delivery apparatus for delivering a medical implant to an implantation location within a patient’s body, the delivery apparatus comprising: a first shaft having a proximal end portion and a distal end portion; a second shaft, wherein the second shaft extends over the first shaft; and a handle assembly comprising: a first slider element wherein the first slider element comprises a threaded distal portion and an unthreaded proximal portion; a second slider element, wherein the second slider element comprises a distal end portion defining a lumen and the unthreaded proximal portion of the first slider element extends into the lumen of the second slider element: and a biasing element disposed around the unthreaded proximal portion of the first slider element and having a proximal end which abuts the distal end portion of the second slider element and a distal end that abuts the threaded distal portion of the first slider element, wherein the second shaft extends from the handle assembly and the second shaft is movable between a first flex configuration and a second flex configuration, wherein the second slider element is coupled to the first shaft, and wherein movement of the second shaft from the first flex configuration to the second flex configuration results in expansion of the biasing element and relative axial motion between the first and second slider elements.

2. The delivery apparatus of claim 1, wherein the second slider element is selectively coupled to the first shaft.

3. The delivery apparatus of any one of claims 1-2, wherein the biasing element comprises one or more coil compression springs.

4. The delivery apparatus of any one of claims 1-3, wherein the first flex configuration is an unflexed configuration.

5. The delivery apparatus of any one of claims 1-4, further comprising an inflatable balloon disposed on the distal end portion of the first shaft.

6. An assembly comprising the delivery apparatus of claim 5, and further comprising an expandable medical implant in a radially compressed state.

7. The assembly of claim 6, wherein the expandable medical implant is disposed around the inflatable balloon.

8. The assembly of either claim 6 or claim 7, wherein the implant comprises a prosthetic heart valve.

9. The assembly of claim 8, wherein the prosthetic heart valve comprises an annular frame and a plurality of leaflets disposed in the frame.

10. An assembly for delivering a medical implant to an implantation location within a patient’s body, the assembly comprising: an expandable medical implant in an unexpanded state; and a delivery apparatus configured for implanting a medical implant, comprising: a first shaft having a proximal end portion and a distal end portion, the distal end portion comprising an inflatable balloon; wherein the medical implant is disposed around the inflatable balloon; a second shaft, wherein the second shaft extends coaxially over the first shaft, and the second shaft has a distal end which is movable between a first flex configuration and a second flex configuration; and a handle assembly comprising: an knob comprising inner threads; a first slider element comprising a threaded portion at a distal end and an unthreaded portion wherein the threaded portion is rotatably coupled to the inner threads of the knob; a second slider element comprising a bore wherein the unthreaded portion of the first slider element is sized and shaped to fit within the bore of the second slider element; and a biasing element disposed around the unthreaded portion of the first slider element and having a proximal end which abuts an end portion of the second slider element and a distal end that abuts the threaded portion of the first slider element, wherein the second slider element is coupled to the first shaft, wherein rotation of the knob results in relative motion between the first and second shafts, and wherein movement of the second shaft from the first flex configuration to the second flex configuration results in expansion of the biasing element and the proximal end of the expandable medical implant remaining adjacent to the distal end portion of the second shaft.

11. The assembly of claim 10, wherein the second slider element is selectively coupled to the first shaft.

12. The assembly of any one of claims 10-11, wherein the biasing element comprises one or more coil compression springs.

13. The delivery apparatus of any one of claims 10-12, wherein the movement of the second shaft from the first flex configuration to the second flex configuration results in more flex applied to the second shaft.

14. The assembly of any one of claims 10-13, wherein the implant comprises a prosthetic heart valve.

15. The assembly of claim 14, wherein the prosthetic heart valve comprises an annular frame and a plurality of leaflets disposed in the frame.

16. A handle for a prosthetic implant delivery apparatus, comprising: a first slider element comprising a threaded portion at a distal end and an unthreaded portion, wherein the unthreaded portion defines an outer diameter and the threaded portion extends radially outward from the unthreaded portion outer diameter; a second slider element, comprising a bore defining an inner diameter wherein the unthreaded portion outer diameter of the first slider element is sized and shaped to fit within the inner diameter of the second slider element; and one or more biasing elements disposed around the first slider element and having a proximal end which abuts an end portion of the second slider element and a distal end that abuts the threaded portion of the first slider element, wherein the one or more biasing elements provide axial bias between the first slider element and the second slider element.

17. The assembly of any one of claims 10-11, wherein the biasing element comprises one or more coil springs.

18. The delivery apparatus or assembly as claimed in any one of claims 1-17, wherein the delivery apparatus or assembly is sterilized.

19. A method of implanting a medical implant, comprising: moving one or more biasing elements within a slider assembly from an expanded state to a compressed state by moving a second shaft of a delivery apparatus relative to a first shaft of the delivery apparatus; introducing a delivery apparatus into a patient’s body; and adjusting tension in a pull wire of the delivery apparatus, wherein adjusting the tension in the pull wire results in the one or more biasing elements of the delivery apparatus expanding from a compressed state to an expanded state to maintain a distal end portion of a second shaft in contact with a proximal end of a medical implant which is disposed at the end of the first shaft.

20. The method of claim 19, further comprising advancing a distal end portion of the delivery apparatus towards an implant location until the medical implant is within or adjacent to the desired implant position.

21. The method of either of claim 19 or claim 20, further comprising inflating a balloon, wherein inflating the balloon results in radial expansion of the medical implant.

22. The method of any one of claims 19-21, wherein the medical implant is a prosthetic heart valve, and the method further comprises advancing the distal end portion of the delivery apparatus through the patient’s aorta until the medical implant is within or adjacent to the patient’s native aortic valve.

23. The method of any one of claims 19-22, wherein the method is performed on a living animal or on a simulation.