Delivery device having a nose cone with a ball joint

Abstract

A delivery apparatus for an implantable medical device includes a handle, a shaft having a proximal end portion and a distal end portion, the proximal end portion coupled to the handle, and a nosecone coupled to the distal end portion of the shaft, the nosecone including the proximal end portion and the distal end portion pivotally coupled to the proximal end portion.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of U.S. Provisional Application No. 62 / 986,570, filed March 6, 2020, which is incorporated herein by reference.

[0002] The present disclosure relates to embodiments of prosthetic valve delivery assemblies and related methods. [Background technology]

[0003] Intravascular delivery devices are used in various procedures to deliver prosthetic medical devices or instruments to locations within the body that are not easily accessible by surgery or where non-surgical access is desirable. Access to the target location inside the body can be achieved by inserting and guiding the delivery device through a passageway or lumen within the body (including, but not limited to, blood vessels, the esophagus, the trachea, any portion of the digestive tract, and lymphatic vessels, to name a few). In one particular example, a prosthetic heart valve can be crimped onto the distal end of the delivery device and advanced through the patient's vascular system (e.g., through the femoral artery and the aorta) until the prosthetic valve reaches an implantation site within the heart. The prosthetic valve is then expanded to its functional size, for example, by inflating a balloon on which it is mounted or by deploying the prosthetic valve from a sheath in the delivery device so that it can self-expand to its functional size. Despite recent advances in percutaneous valve technology, there remains a need for improved systems and methods for the delivery of such valves. [Prior art documents] [Patent documents]

[0004] [Patent Document 1] U.S. Patent Application Publication No. 2018 / 0153689 [Patent Document 2] U.S. Patent Application Publication No. 2018 / 0344456 [Patent Document 3] U.S. Patent Application Publication No. 2019 / 0060057 [Patent Document 4] U.S. Patent Application Publication No. 2015 / 0135506 [Patent Document 5] U.S. Patent Application Publication No. 2014 / 0296962 [Patent Document 6] U.S. Patent No. 6,730,118 [Patent Document 7] U.S. Patent No. 7,393,360 [Patent Document 8] U.S. Patent No. 7,510,575 [Patent Document 9] U.S. Patent No. 7,993,394 [Patent Document 10] U.S. Patent No. 8,652,202 [Patent Document 11] U.S. Patent Application Publication No. 2018 / 0325665 Summary of the Invention [Problem to be solved by the invention]

[0005] The present invention provides improved systems and methods for the delivery of prosthetic valves. [Means for solving the problem]

[0006] Described herein are prosthetic valve delivery assemblies and associated methods that can be used to deliver a prosthetic valve to a location within a subject's body. In some implementations, the prosthetic valve delivery assemblies can be used to deliver a medical device, such as to the subject's heart, through the vascular system.

[0007] In one exemplary embodiment, a delivery apparatus for an implantable medical device is provided. The delivery apparatus includes a handle, a shaft, and a nosecone. The shaft has a proximal end portion and a distal end portion, the proximal end portion being coupled to the handle. The nosecone is coupled to the distal end portion of the shaft and includes the proximal end portion and the distal end portion pivotally coupled to the proximal end portion.

[0008] In another exemplary embodiment, a delivery device includes a handle, a first shaft, a second shaft extending over the first shaft, and a nosecone. The first shaft has a proximal end portion and a distal end portion, the proximal end portion being coupled to the handle, and the second shaft includes a delivery capsule along its distal end. The nosecone is coupled to the distal end portion of the first shaft and has a proximal end portion and a distal end portion pivotally coupled to the proximal end portion by a ball-and-socket joint. The ball-and-socket joint includes a ball disposed in a socket, one of the proximal and distal end portions including the ball and the other of the proximal and distal end portions including the socket. The proximal end portion of the nosecone includes a first lumen, and the distal end portion of the nosecone includes a second lumen. The first and second lumens are sized to receive a guidewire therethrough, and the distal end portion of the first shaft extends into the first lumen of the proximal end portion. The delivery capsule is configured to maintain the medical implant in a radially folded state for delivery into the patient, and the distal end section of the delivery capsule is sized to extend over the proximal end portion of the nosecone.

[0009] In another exemplary embodiment, a delivery device includes a handle, a shaft, and a nosecone. The shaft has a proximal end portion and a distal end portion, the proximal end portion coupled to the handle. The nosecone is coupled to the distal end portion of the shaft, the nosecone including the proximal end portion and the distal end portion pivotally coupled to the proximal end portion by a ball and socket joint. The ball and socket joint includes a ball disposed in a socket, the proximal end portion includes the socket, and the distal end portion includes the ball.

[0010] In another exemplary embodiment, a delivery device includes a handle, a shaft, and a nosecone. The shaft has a proximal end portion and a distal end portion, the proximal end portion being coupled to the handle. The nosecone is coupled to the distal end portion of the shaft and includes the proximal end portion, the distal end portion being coupled to the proximal end portion, and a coupling means for coupling the distal and proximal end portions. The coupling means allows for pivotal movement of the distal end portion relative to the proximal end portion.

[0011] In one exemplary embodiment, a delivery assembly for an implantable medical device is provided. The delivery assembly includes a delivery apparatus having a handle, a nosecone, an expandable implantable medical device, and a shaft having a proximal end portion and a distal end portion. The proximal end portion of the shaft is coupled to the handle, and the distal end portion is coupled to the nosecone. The expandable implantable medical device is mounted in a radial configuration around the distal end portion of the shaft. The nosecone includes a proximal end portion and a distal end portion pivotally coupled to the proximal end portion.

[0012] In another exemplary embodiment, a delivery assembly includes a delivery device having a handle, a nosecone, a shaft having proximal and distal end portions, and an expandable implantable medical device. The nosecone is coupled to the distal end portion, and the proximal end portion is coupled to the handle. The expandable implantable medical device is mounted in a radial configuration around the distal end portion of the shaft. The nosecone includes a proximal end portion and a distal end portion pivotally coupled to the proximal end portion by a ball and socket joint. One of the proximal and distal end portions includes a ball, and the other of the proximal and distal end portions includes a socket.

[0013] In another exemplary embodiment, a delivery assembly includes a delivery device having a handle, a nosecone, a first shaft, a second shaft extending over the first shaft, and an expandable implantable medical device. The first shaft includes a distal end portion and a proximal end portion coupled to the handle. The second shaft includes a delivery capsule along its distal end section, and the nosecone has a proximal end portion and a distal end portion pivotally coupled to the proximal end portion. The expandable implantable medical device is mounted in a radially compressed configuration around the distal end portion of the first shaft and within the delivery capsule of the second shaft. The distal and proximal end portions of the nosecone are pivotally coupled by a ball-and-socket joint, which includes a ball disposed in a socket. The distal end portion includes the ball, and the proximal end portion includes the socket. The distal end section of the delivery capsule is sized to extend over the proximal end portion of the nosecone.

[0014] In one exemplary embodiment, a method for delivering an implantable medical device is provided. The method can include advancing an expandable implantable medical device mounted in a radially compressed configuration about a distal end portion of a shaft of a delivery device into a patient's natural lumen, with at least a distal end portion of a nosecone of the delivery device contacting a wall of the patient's vasculature. Contact between the nosecone and the wall of the vasculature causes the distal end portion of the nosecone to pivot relative to the proximal end portion of the nosecone. In some embodiments, contact between the nosecone and the wall of the vasculature causes the distal end portion of the nosecone to rotate relative to the proximal end portion of the nosecone.

[0015] In one exemplary embodiment, a method for implanting a prosthetic valve into a patient's aortic valve annulus is provided, the method including the steps of: advancing an expandable prosthetic valve and a distal end portion of a delivery device shaft into the patient's aorta, the prosthetic valve being mounted in a radially compressed configuration around the distal end portion of the shaft, at least a distal end portion of a delivery device nosecone contacting a wall of the aorta, the distal end portion of the nosecone pivotally coupled to a proximal end portion of the nosecone, the proximal end portion coupled to the distal end portion of the shaft, wherein contact between the nosecone and the wall of the aorta causes the distal end portion of the nosecone to pivot relative to the proximal end portion of the nosecone, the distal end portion of the shaft, and the prosthetic valve; inserting the distal end portion of the shaft into the patient's aortic valve annulus, the nosecone extending through the aortic valve annulus and into the patient's left ventricle; and expanding the prosthetic valve within the aortic valve annulus from the radially compressed state to a radially expanded state.

[0016] In another exemplary embodiment, a delivery apparatus for an implantable medical device includes a handle, a first shaft, a second shaft extending over the first shaft, and a nosecone coupled to a distal end portion of the first shaft. The first shaft includes a proximal end portion and a distal end portion, the proximal end portion being coupled to the handle. The second shaft includes a delivery capsule along its distal end. The nosecone includes the proximal end portion, an intermediate portion pivotally coupled to the proximal end portion by a first ball-and-socket joint, and a distal end portion pivotally coupled to the intermediate portion by a second ball-and-socket joint. Each ball-and-socket joint includes a ball disposed in a socket.

[0017] In one exemplary embodiment, a delivery apparatus for an implantable medical device includes a handle, a shaft having a proximal end portion and a distal end portion, the proximal end portion coupled to the handle, and a nosecone coupled to the distal end portion of the shaft, the nosecone including the proximal end portion and the distal end portion pivotally coupled to the proximal end portion by a plurality of ball and socket joints.

[0018] The various devices of this disclosure may be used in combination or separately. This Summary is provided to introduce a selection of concepts in a simplified form, which 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 present disclosure will become more apparent from the following Detailed Description, the claims, and the accompanying drawings. [Brief explanation of the drawings]

[0019] [Figure 1]FIG. 1 is a perspective view of a delivery assembly including a mechanically expandable prosthetic heart valve and a delivery device. [Figure 2] FIG. 1 is a perspective view of a prosthetic heart valve. [Figure 3] FIG. 1 is a side view of the bare frame of the prosthetic heart valve in a radially compressed configuration. [Figure 4] FIG. 10 is a side view of the proximal end portion of the delivery device. [Figure 5] FIG. 10 is a side view of a nosecone coupled to a distal end portion of a delivery device showing the delivery capsule retracted relative to the nosecone. [Figure 6] FIG. 10 is another side view of the nosecone coupled to the distal end portion of the delivery device, showing the delivery capsule extending partially over the nosecone. [Figure 7] FIG. 10 is a side view of a nosecone coupled to a nosecone shaft of a delivery device. [Figure 8] FIG. 10 is a side cross-sectional view of a nosecone coupled to a nosecone shaft of a delivery device. [Figure 9] FIG. 10 is a side view of a nosecone coupled to a delivery device showing a distal end portion of the nosecone pivoted relative to a proximal end portion of the nosecone. [Figure 10] FIG. 10 is a side cross-sectional view of a nosecone coupled to a delivery device showing a distal end portion of the nosecone pivoted relative to a proximal end portion of the nosecone. [Figure 11] FIG. 10 is a side view of a nosecone coupled to a delivery device showing the distal end portion of the nosecone pivoted relative to the proximal end portion and intermediate portion. [Figure 12] 12 is a side cross-sectional view of the nosecone of FIG. 11 coupled to a delivery device showing the distal end portion of the nosecone pivoted relative to the proximal end portion and intermediate portion. [Figure 13] FIG. 10 shows the distal end of a delivery assembly including a nosecone being advanced through the arch of the vascular system of the heart (shown in cross section). [Figure 14]10A-10C show the rigid section of the delivery assembly contacting the wall of the heart's vasculature and the distal end of the nosecone pivoting relative to the delivery assembly. [Figure 15] 1A-1C illustrate an example of an implantation procedure in which a prosthetic heart valve is implanted into a heart (shown in cross section) by a delivery device. [Figure 16] 1A-1C illustrate an example of an implantation procedure in which a prosthetic heart valve is implanted into a heart (shown in cross section) by a delivery device. DETAILED DESCRIPTION OF THE INVENTION

[0020] General Considerations It should be understood that the disclosed embodiments may be adapted for delivering and implanting a prosthetic heart valve into any of the heart's native annulus (e.g., aortic, pulmonary, mitral, and tricuspid annulus) and may be used with any of a variety of delivery devices for delivering a prosthetic valve using any of a number of delivery approaches (e.g., retrograde, antegrade, transseptal, transseptal, transventricular, transatrial, etc.). Although the delivery apparatus embodiments disclosed herein are described in the context of implanting a prosthetic heart valve, the delivery apparatus may be used to deliver and implant any of a variety of medical implants in the body (including, but not limited to, venous valves, stents, grafts, heart valve repair devices, etc.).

[0021] For purposes of this description, certain aspects, advantages, and novel features of the disclosed embodiments are described herein. The disclosed methods, apparatus, and systems should not be construed as limiting in any way. Instead, the present disclosure is directed to all novel and non-obvious features and aspects of the various disclosed embodiments, alone and in various combinations and subcombinations with one another. The methods, apparatus, and systems are not limited to any particular aspect or feature or combination thereof, nor do the disclosed embodiments require that any one or more particular advantages be present or problems be solved.

[0022] Although some operations of the disclosed embodiments are described in a particular sequential order for convenient presentation, it should be understood that this description style encompasses rearrangement unless a particular order is required by specific language set forth below. For example, operations described sequentially may, in some cases, be rearranged or performed simultaneously. Moreover, for simplicity, the accompanying figures may not show the various ways in which the disclosed methodologies can be used with other methodologies. Furthermore, the description sometimes uses terms such as "providing" or "realizing" to describe the disclosed methodologies. These terms are high-level abstractions of actual operations that are performed. The actual operations corresponding to these terms may vary depending on the particular implementation and are readily discernible by those skilled in the art.

[0023] 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. Furthermore, the term "includes" means "comprises." Furthermore, 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 coupled or associated items, unless specific language to the contrary is used.

[0024] As used herein, the term "proximal" refers to a position, direction, or portion of a device that is closer to the user and farther away from the implantation site. As used herein, the term "distal" refers to a position, direction, or portion of a device that is farther away from the user and closer to the implantation site. Thus, for example, proximal movement of a device is movement of the device away from the implantation site toward the user (e.g., out of the patient's body), while distal movement of the device is movement of the device away from the user toward the implantation site (e.g., into the patient's body). The terms "longitudinal" and "axial" refer to axes extending in the proximal and distal directions, unless expressly defined otherwise.

[0025] Illustrative Embodiments Described herein are delivery devices and methods for implanting prosthetic heart valves or other expandable medical devices. The disclosed delivery devices and methods can, for example, help reduce the axial force required to advance the delivery device around the vasculature arch. Reducing the axial force can reduce the risk of gap formation between the nosecone and the delivery capsule during implantation. The disclosed delivery devices and methods can also provide increased bendability in the nosecone, reducing frictional forces between the nosecone and the guidewire and / or the walls of the surrounding natural vasculature. The delivery devices and nosecones disclosed herein can also have a rigid section with a shorter overall length than the rigid sections of other standard delivery systems.

[0026] FIG. 1 illustrates a delivery assembly 100 according to one embodiment. In the illustrated embodiment, the delivery assembly 100 includes a prosthetic heart valve 104 and a delivery device 102 including a nose cone 106. The prosthetic valve may be configured to replace a native heart valve (e.g., an aortic valve, a mitral valve, a pulmonary valve, and / or a tricuspid valve). As shown, the prosthetic valve 104 may be releasably coupled to a distal end portion of the delivery device 102. The delivery device 102 and the nose cone 106 coupled to the distal end portion of the delivery device 102 may be used to deliver and implant the prosthetic valve 104 into a patient's native heart valve (e.g., as shown in FIGS. 15 and 16 ). Additional details regarding the prosthetic valve 104, the delivery device 102, and the nose cone 106 are provided below.

[0027] 2 shows a prosthetic valve 104, which in the illustrated embodiment is a mechanically expandable heart valve. In other embodiments, the delivery device 102 can be used to deliver and implant a balloon-expandable heart valve or a self-expandable heart valve. When used to deliver a balloon-expandable heart valve, the delivery device 102 includes an inflatable balloon along its distal end portion, as known in the art, to expand the heart valve to a functional size. When used to deliver a self-expandable heart valve, the heart valve can be kept in a radially collapsed state within a sheath or capsule (e.g., capsule 186) for delivery into the body and can self-expand to a functional size by deploying the heart valve from the sheath, as known in the art.

[0028] As shown, for example, the prosthetic valve 104 can include three major components: a frame 108, a valve structure 110, and commissure members 112 (e.g., in the illustrated embodiment, three actuators). The frame 108 (which may also be referred to as a "stent" or a "support structure") can be configured to support the valve structure 110 and to anchor the prosthetic valve 104 within the native heart valve. The valve structure 110 is coupled to the frame 108 and / or to the commissure members 112. The valve structure 110 is configured to allow blood flow through the prosthetic valve 104 in one direction (i.e., the antegrade direction) and restrict blood flow through the prosthetic valve 104 in the opposite direction (i.e., the retrograde direction). Commissure members 112 are coupled to frame 108 and may be configured (e.g., as actuators) to adjust the expansion of frame 108 to multiple configurations, including one or more functional or expanded configurations (e.g., FIG. 2), one or more delivery or compressed configurations (e.g., FIG. 3), and / or one or more intermediate configurations between the functional and delivery configurations. It should be noted that for purposes of illustration, valve structure 110 of prosthetic valve 104 is not shown in FIGS. 1 and 3.

[0029] 2, the frame 108 of the prosthetic valve 104 has a first end 114 and a second end 116. In the illustrated embodiment, the first end 114 of the frame 108 is the inflow end and the second end 116 of the frame 108 is the outflow end. In other embodiments, the first end 114 of the frame 108 can be the outflow end and the second end 116 of the frame 108 can be the inflow end.

[0030] Additionally, the frame 108 may be made from any suitable material, including a biocompatible metal and / or a biocompatible polymer. Examples of biocompatible metals from which the frame may be formed include stainless steel, cobalt chromium alloy, and / or nickel titanium alloy (which may also be referred to as "NiTi" or "nitinol").

[0031] Continuing to refer to FIG. 2, the frame 108 includes a plurality of interconnected struts 118 arranged in a lattice-type pattern. In FIG. 2, the frame 108 of the prosthetic valve 104 is in a radially expanded configuration, which results in the struts 118 of the frame 108 extending obliquely relative to the longitudinal axis of the prosthetic valve 104. In other configurations, the struts 118 of the frame 108 may be offset by an amount different from that shown in FIG. 2. For example, FIG. 3 shows the frame 108 of the prosthetic valve 104 in a radially compressed configuration. In this configuration, the struts 118 of the frame 108 extend parallel (or at least substantially parallel) to the longitudinal axis of the prosthetic valve 104.

[0032] To facilitate movement between the expanded and compressed configurations, the struts 118 of the frame 108 are pivotally connected to one another at one or more pivot joints along the length of each strut. For example, each of the struts 118 may be formed with apertures 120 at opposite ends and along the length of the strut. The frame 108 includes hinges where the struts 118 overlap and are pivotally connected together via fasteners (such as rivets or pins) that extend through the apertures 120 in the struts 118. The hinges allow the struts 118 to pivot relative to one another when the frame 108 moves between the radially expanded and radially compressed configurations (e.g., during assembly, preparation, and / or implantation of the prosthetic valve 104).

[0033] In some embodiments, the frame 108 may be constructed by forming individual components (e.g., struts 118 and pins of the frame 108) and then mechanically assembling and connecting the individual components together. In other embodiments, the struts are not connected to each other by respective hinges, but are otherwise pivotable or bendable relative to each other to provide radial expansion and contraction of the frame. For example, the frame may be formed (e.g., via laser cutting, electroforming, or physical vapor deposition) from a single piece of material (e.g., metal tubing). Further details regarding the construction of frames and prosthetic valves are described in U.S. Patent Nos. 6,275,132; 6,275,132; and 6,275,132, U.S. Patent Application No. 62 / 869,948, and International Application No. PCT / US2019 / 056865, which are incorporated herein by reference. Additional examples of expandable prosthetic valves that may be used with the delivery devices disclosed herein are described in U.S. Patent Nos. 6,275,132 and 6,275,132, which are incorporated herein by reference.

[0034] 2 , the valve structure 110 of the prosthetic valve 104 is coupled to the frame 108. The valve structure 110 is configured to permit blood flow through the prosthetic valve 104 from the inflow end 114 to the outflow end 116 and to restrict blood flow through the prosthetic valve 104 from the outflow end 116 to the inflow end 114. The valve structure 110 can include, for example, a leaflet assembly including one or more leaflets 122 (e.g., in the illustrated embodiment, three leaflets).

[0035] The leaflets 122 of the prosthetic valve 104 may be made from a flexible material. For example, the leaflets 122 of the valve leaflet assembly may be made entirely or partially from a biological material, a biocompatible synthetic material, or other such material. Suitable biological materials may include, for example, bovine pericardium (or pericardium from other sources).

[0036] The leaflets 122 may be arranged to form commissures 124 (e.g., a pair of adjacent leaflets), which may be attached, for example, to respective commissure members 112. Further details regarding prosthetic heart valves (including the manner in which the valve structure 110 may be coupled to the frame 108 of the prosthetic valve 104) may be found in U.S. Patent Nos. 6,273,299; ... and 6,273,299, and U.S. Patent No. 6,273,299, which are incorporated herein by reference.

[0037] The valve structure 110 may be coupled to commissure members 112, which may be configured for actuation, for example. As shown in FIG. 2 , the commissure members 112 are attached to and circumferentially spaced about the inner surface of the frame 108. The commissure members 112 are configured to, among other things, radially expand and / or radially compress the frame 108. For this reason, the commissure members 112 may also be referred to as “expansion mechanisms.” The commissure members 112 may also be configured to lock the frame 108 in a desired expanded configuration. Accordingly, the commissure members 112 may also be referred to as “rockers” or “locking mechanisms.” Each of the commissure members 112 may be configured to form a releasable connection with one or more respective actuation shafts of a delivery device. Additional details regarding valve structures and corresponding delivery devices coupled to prosthetic valves including one or more actuators can be found, for example, in U.S. Patent Application Nos. 62 / 945,039 and 62 / 869,948, which are incorporated herein by reference.

[0038] 2 includes three commissure members 112 (e.g., actuators), a variety of prosthetic valves and / or expansion mechanisms may be used with the delivery devices disclosed herein. For example, other embodiments may include a variety of self-expandable and / or mechanically expandable prosthetic valves (such as those prosthetic valves incorporated by reference herein) or may be used with any variety of expandable mechanisms (e.g., inflatable devices, actuators, biasing members, etc.).

[0039] Although not shown, the prosthetic valve 104 may also include one or more skirts or sealing members. For example, the prosthetic valve 104 may include an inner skirt mounted on the inner surface of the frame 108. The inner skirt may function as a sealing member to prevent or reduce paravalvular leakage, secure the valve leaflets 122 to the frame 108, and / or protect the valve leaflets 122 against damage caused by contact with the frame 108 during crimping and during the work cycle of the prosthetic valve 104. The prosthetic valve 104 may also include an outer skirt mounted on the outer surface of the frame 108. The outer skirt may function as a sealing member for the prosthetic valve 104 by sealing against the tissue of the native annulus and thus reducing paravalvular leakage around the prosthetic valve. The inner and outer skirts may be formed from any of a variety of suitable biocompatible materials, including any of a variety of synthetic materials (e.g., PET) or natural tissue (e.g., pericardial tissue). The inner and outer skirts may be attached to the frame using sutures, adhesives, welding, and / or other means for attaching the skirts to the frame.

[0040] 4-6 illustrate a delivery device 102 and its components, which may also be referred to as a “valve catheter” or a “delivery catheter.” As shown, the delivery device 102 includes a handle 126, a first shaft 128, a second shaft 130, a nosecone shaft 132, a nosecone 106, and an expansion (or alternatively, compression) component 134 (e.g., a support sleeve, an actuation shaft, a recompression shaft, etc.).

[0041] The handle 126 is configured for manipulating the shaft and sleeve relative to one another. The prosthetic heart valve 104 may be releasably coupled to a distal end portion of the delivery device 102 (e.g., FIGS. 5 and 16), and the delivery device 102 may be used to position the prosthetic valve 104 and / or to expand, compress, and lock the prosthetic valve 104 in a desired radially expanded configuration.

[0042] The handle 126 of the delivery device 102 includes one or more mechanisms configured to move the shaft and sleeve relative to one another. For example, as shown in FIG. 4 , the handle 126 includes a first mechanism 136, a second mechanism 138, a third mechanism 140, and / or a fourth mechanism 142.

[0043] A first mechanism 136 of the handle 126 is coupled to the first and second shafts 128, 130 and is configured to axially move the first and second shafts 128, 130 relative to one another. As described further below, the first mechanism 136 of the handle 126 may be used to deploy the prosthetic valve 104 from the delivery capsule on the first shaft 128. As such, the first mechanism 136 may be referred to as a “deployment mechanism.”

[0044] In the illustrated embodiment, the first mechanism 136 includes a first knob 144 configured to actuate the first mechanism 136. Although not shown, in other embodiments, the first mechanism 136 can include various other types of actuators (e.g., buttons, switches, etc.) configured to actuate the first mechanism 136. The first mechanism 136 can also include one or more other non-illustrated components (e.g., electric motors, rotatable shafts, drive screws, gear assemblies, etc.) configured to facilitate and / or limit relative axial movement between the first shaft 128 and the second shaft 130. For example, the first mechanism 136 can be configured such that rotating the first knob 144 (and / or the electric motor) relative to the housing of the handle 126 results in relative axial movement between the first shaft 128 and the second shaft 130.

[0045] The second and third mechanisms 138, 140 of the handle 126 are coupled and configured to operate the expansion component 134 (e.g., an actuation shaft, a support sleeve, etc.). For example, the second mechanism 138 of the handle 126 may be used to radially expand and / or compress the prosthetic valve 104 when the prosthetic valve 104 is coupled to the delivery device 102 via the expansion component 134. Meanwhile, the third mechanism may be used to simultaneously couple and release the expansion component 134 from the prosthetic valve 104. Thus, the second mechanism 138 may be referred to as an "actuation mechanism" and / or an "expansion mechanism," and the third mechanism may be referred to as a "release mechanism" or a "coupling mechanism."

[0046] In the illustrated embodiment, the second and third mechanisms 138, 140 include second and third knobs 146, 148, respectively, that are configured to actuate the second and third mechanisms 138, 140 to facilitate and / or limit relative axial and / or rotational movement of the expansion component 134. In other embodiments, the second and third mechanisms 138, 140 can include various other types of actuators (e.g., electric motors, drive screws, gear assemblies, and / or other components).

[0047] A fourth mechanism 142 of the handle 126 is coupled to the nosecone shaft 132 and is configured to axially move the nosecone shaft 132 and the nosecone 106 relative to the first and second shafts 128, 130. As such, the fourth mechanism 142 may be referred to as a “nose cone mechanism.”

[0048] In the illustrated embodiment, the fourth mechanism 142 includes a slider 150 configured to actuate the fourth mechanism 142. Although not shown, the fourth mechanism 142 can include various other components configured to facilitate and / or limit relative axial movement of the nosecone shaft 132 and the first and second shafts 128, 130. For example, in some embodiments, the fourth mechanism 142 can include one or more biasing members (e.g., springs) configured to bias the nosecone shaft 132 to a predetermined axial position relative to the first and second shafts 128, 130. In other embodiments, the fourth mechanism can include a rotatable knob, an electric motor, and / or a drive screw configured to convert relative rotational movement between the knob (and / or motor) and the housing into relative axial movement between the nosecone shaft and the first and second shafts.

[0049] During the implantation procedure, the delivery device is advanced through the patient's vasculature, which may include various curves, including some relatively sharp curves (e.g., the native aortic arch, as shown in FIGS. 13-16 ). When advanced through the curve, the nosecone may be forced axially against the inner wall of the vessel. This axial force, coupled with the rigidity and length of conventional nosecones, can result in undesirable gap formation between the outer shaft of the delivery device and the nosecone. For example, as the delivery device is advanced around the native arch, the nosecone may contact the surrounding vessel wall, causing the nosecone to twist and / or rotate relative to the outer shaft. As the nosecone twists and rotates relative to the catheter, it can apply force against the inner wall of the outer shaft, causing separation, which can lead to unwanted leakage into the delivery catheter and possibly tissue damage.

[0050] Disclosed herein are nosecones configured to reduce axial forces and / or gap formation generated when a delivery assembly is advanced around curves in a patient's vasculature lumen (such as the aortic arch). The disclosed nosecones can, for example, provide added flexibility and freedom of movement to the distal end of the delivery device, helping to reduce friction and limit gap formation during vascular procedures. In some cases, the nosecone can be coupled to the distal end of the delivery device proximate the delivery capsule. The nosecones disclosed herein can be used, for example, with delivery device 102.

[0051] Generally speaking, the disclosed nosecones operate by allowing the portion of the nosecone that extends beyond the end of the outer shaft of the delivery device to pivot relative to the portion of the nosecone that is positioned within the outer shaft. In this manner, the nosecone that contacts the wall of the vasculature pivots relative to the remainder of the delivery device, thereby reducing friction against surrounding tissue and / or preventing separation between the nosecone and the outer shaft.

[0052] As shown in FIG. 1 , the nosecone 106 can be coupled to the distal end portion of the delivery device 102. FIGS. 7 and 8 (cross-section) show an exemplary nosecone 106 in a straight (or substantially straight) configuration. In the illustrated embodiment, the nosecone 106 can include a proximal end portion 152, a distal end portion 154, and an outer ridge 156 that extends outward from and circumferentially around the surface of the proximal end portion 152. The nosecone 106 can have a total length 157, with the proximal end portion 152 having a length 153 and the distal end portion 154 having a length 155, measured from the distal-most point of the proximal end portion 152 to the distal-most point of the distal end portion 154. Proximal end portion 152 can also have a shaft length 159, which is the length of proximal end portion 152 disposed within the lumen of first shaft 128 when first shaft 128 extends over proximal end portion 152 and abuts outer ridge 156 (e.g., FIG. 6 ). Shaft length 159 is measured from the proximal-most point of outer ridge 156 to the proximal-most point of proximal end portion 152.

[0053] As shown in FIGS. 7 and 8 , the proximal end portion 152 of the nosecone 106 is coupled to the nosecone shaft 132 of the delivery device 102 and can have both an elongated shape and a tapered portion that narrows toward the nosecone shaft 132. The proximal end portion 152 can include a lumen 176 that receives the distal end portion of the nosecone shaft 132. The proximal end portion 152 can be coupled to the nosecone shaft 132 by various methods (e.g., overmolding, radio frequency welding, via adhesive, and / or combinations thereof). A combination of two or more of these methods can combine molding and / or welding with adhesive applied through an opening 158 that extends through the body of the proximal end portion 152 and into the lumen 176, allowing the adhesive to bond to the nosecone shaft 132.

[0054] The distal end portion 154 is coupled to the proximal end portion 152 and can be tapered from the edge of the proximal end portion 152 to the distal end of the distal end portion 154. In the illustrated embodiment, the proximal end portion 152 and the distal end portion 154 of the nosecone 106 are pivotally and rotatably coupled. For example, the illustrated embodiment shows that the proximal end portion 152 and the distal end portion 154 collectively comprise and are pivotally coupled by a ball and socket joint 160. The ball and socket joint 160 can include a ball 162 and a socket 164.

[0055] In some embodiments, the proximal end portion 152 includes a socket 164, and the distal end portion 154 includes a ball 162 of a joint 160 disposed within the socket 164. As such, the distal end portion 154 is configured to pivot and / or rotate relative to the proximal end portion 152 when the distal end portion contacts the surrounding vessel wall. As such, the distal end of the distal end portion 154 is configured to move in three-dimensional space relative to the proximal end portion 152. For example, the distal end portion 154 can move laterally and up and down relative to the proximal end portion 152.

[0056] In the illustrated embodiment, socket 164 includes a cavity in the proximal end portion that is sized and shaped to extend at least partially over and secure ball 162 of distal end portion 154, allowing the distal end portion to freely pivot and rotate relative to proximal end portion 152. In some embodiments, movement of distal end portion 154 can be limited to pivotal movement relative to proximal end portion 152 (e.g., not rotatable).

[0057] In other embodiments, the configuration of ball and socket joint 160 may be reversed, with proximal end portion 152 including the ball and distal end portion 154 including the socket. Although not shown, proximal end portion 152 and distal end portion 154 may include other components that allow distal end portion 154 to pivot and / or rotate relative to proximal end portion 152, and thereby be pivotally coupled. For example, proximal end portion 152 and distal end portion 154 may be coupled together by a rotatable hinge joint, a knuckle joint, and / or other desired configuration.

[0058] 7 and 8 , proximal end portion 152 includes a first lumen 166 and distal end portion 154 includes a second lumen 168, each sized to allow a guidewire 170 to be passed therethrough. Proximal end portion first lumen 166 can include a socket lumen 172, a tapered lumen 174, and a shaft lumen 176, the shaft lumen 176 being sized to receive the nosecone shaft 132 for coupling proximal end portion 152 to delivery device 102. In the illustrated embodiment, socket lumen 172 is adjacent to tapered lumen 174, which is adjacent to shaft lumen 176, and the respective lumens are configured to align (or substantially align) such that first lumen 166 is continuous throughout proximal end portion 152.

[0059] The second lumen 168 of the distal end portion 154 can include a tapered lumen 178 and a distal end lumen 180. In the illustrated embodiment, the tapered lumen 178 of the distal end portion 154 is positioned within the ball 162, and the distal end lumen 180 is positioned within the tapered section 151 of the distal end portion. As such, the distal end portion 154 of the nosecone 106 can include two portions that are coupled together to form a continuous lumen (e.g., the second lumen 168) and allow the guidewire 170 to extend therethrough. In the illustrated example, the ball 162 includes a protrusion 182 and the tapered section 151 includes a cavity 184 that is sized to form a snap-fit ​​connection with the protrusion 182, such that the tapered section 151 and the ball 162 are securely coupled to one another. Alternatively, ball 162 can include cavity 184 and tapered section 151 can include protrusion 182. Although not shown, tapered section 151 and ball 162 can be releasably coupled and / or coupled by a threaded structure (e.g., bolt, screw, etc.), pin, adhesive, or other attachment means. In alternative embodiments, distal end portion 154 can have a one-piece or unitary construction (e.g., ball 162 and tapered section 151 are part of the same unitary body).

[0060] 9 and 10 , the tapered lumens 174, 178 of the first and second lumens 166, 168 are configured to ensure a continuous lumen (e.g., a passageway, a channel, etc.) extends the length of the nosecone when the distal end portion 154 pivots and / or rotates relative to the proximal end portion 152. For example, in the embodiment shown in FIG. 10 , the tapered lumens 174, 178 taper (i.e., narrow) in opposite directions along the longitudinal axis of the nosecone 106. In this manner, when the distal end portion 154 (or, alternatively, the proximal end portion 152) pivots relative to the delivery device 102, the wider diameter portions of the tapered lumens 174, 178 allow the guidewire 170 to extend through the nosecone 106 without obstruction and / or friction that would otherwise be caused by contact from a smaller lumen diameter. As such, nosecone 106 is configured to follow the curved path of guidewire 170 as the delivery device is advanced through and around the natural arc of the patient's vasculature.

[0061] 11 and 12 , the nosecone 106 can have one or more additional ball-and-socket joints in addition to the ball-and-socket joint 160. For example, the ball 162 of the first joint 160 can act as an intermediate portion defining a second socket 165, which is sized and shaped to extend partially over and secure the second ball 163 of the distal end portion 154. As such, the distal end portion 154 is pivotally and rotatably coupled to the ball 162 of the joint 160. In this manner, the distal end portion 154 is configured to pivot and / or rotate relative to the ball 162 and the proximal end portion 152 when the distal end portion 154 contacts the surrounding vessel wall. In the illustrated embodiment, the ball 163 is securely coupled to the tapered section 151 by a snap-fit ​​connection including a protrusion 182 extending into a cavity 184 of the tapered section 151. Alternatively, the ball 163 may include the cavity 184 and the tapered section 151 may include the protrusion 182 .

[0062] Distal end portion 154 can also include a third lumen 169 sized to allow a guidewire 170 to pass its length, while ball 162 can include a second lumen 168. As shown in FIG. 12 , third lumen 169 can include a tapered lumen 181 and a distal end lumen 180 extending through prongs 182 and tapered section 151, and second lumen 168 can include a tapered lumen 178 and a socket lumen 179 extending through ball 162. As such, the tapered lumens 174, 178, 181 of the first, second, and third lumens 166, 168, 169 are configured to ensure a continuous lumen extends through the length of the nosecone as the distal end portion 154 pivots and / or rotates relative to the proximal end portion 152 and the ball 162. In some embodiments, the configuration of the ball and socket joint 161 can be reversed, such that the intermediate portion (e.g., ball 162) includes a second ball 163 that extends outward in the distal direction and is disposed within a socket 165 that is defined by the distal end portion 154 and faces proximally. In alternative embodiments, the nosecone 106 can include three or more ball and socket joints connected end to end.

[0063] 1 and 4 , a proximal end portion of the first shaft 128 can be coupled to and extend distally from the handle 126. The first shaft 128 includes a lumen for accommodating the second shaft 130 of the delivery device 102. The distal end portion of the first shaft 128 is configured to receive the prosthetic valve 104 in a radially compressed configuration (e.g., FIGS. 5 and 6 ). As such, the first shaft 128 can be referred to as a “sheath” or “delivery capsule” 186. Alternatively, the delivery capsule 186 can be a separately formed component coupled to the distal end portion of the first shaft 128. As shown in FIG. 5, the second shaft 130 extends coaxially through the first shaft 128, is axially movable relative to the first shaft 128, and can include a single (or multiple) lumen extending coaxially therethrough, which houses a portion of the expansion component 134.

[0064] The prosthetic valve 104 can be releasably coupled to a distal end portion of the delivery device 102 to form a delivery assembly (e.g., FIGS. 1 and 5-6), and the delivery device 102 can be used to implant the prosthetic valve 104 within a patient's body (e.g., FIGS. 13-16). With the prosthetic valve 104 releasably coupled to the delivery device 102, the prosthetic heart valve 104 can be radially compressed and inserted into the delivery capsule 186 using a crimping device or other means (e.g., an actuator or recompression member (e.g., expansion and / or compression component 134)).

[0065] 5 and 6 show the prosthetic valve 104 in a radially compressed configuration. The first shaft 128 of the delivery device 102 may be advanced over the second shaft 130 of the delivery device 102, the prosthetic valve 104, and the proximal end portion 152 of the nosecone 106. As such, the prosthetic valve 104 and the proximal end portion 152 of the nosecone 106 are disposed within the lumen of the first shaft 128 (e.g., within a delivery capsule 186). As shown in FIG. 6, the capsule 186 extends over the tapered portion of the proximal end portion 152 and abuts the ridge 156 of the nosecone 106, creating a flush (or substantially flush) surface between the capsule 186 and the nosecone 106. Advancement of the first shaft 128 may be achieved, for example, by actuating the first mechanism 136 of the handle 126.

[0066] The distal end portion of the delivery assembly 100 may then be inserted into the patient's vasculature, and the prosthetic valve 104 may be advanced to an implantation site using the delivery device 102. For example, Figures 13-16 show an exemplary implantation procedure for implanting the prosthetic valve 104 into the patient's heart 188 using a transfemoral delivery procedure. In other embodiments, a variety of other delivery procedures may be used, such as transventricular, transapical, transseptal, etc.

[0067] 13 , the distal end portion of delivery assembly 100 is inserted into the vasculature of a patient's heart 188, with first shaft 128 and nosecone 106 extending through the patient's aorta 190 and approaching the aortic arch 192. As shown in FIG. 14 , when an axial force is applied to delivery device 102 (e.g., at handle 126) to advance delivery device 102 around the aortic arch 192, nosecone 106, first shaft 128, and delivery capsule 186 may contact the surrounding aortic wall. Collectively, nosecone 106, delivery capsule 186, and a portion of first shaft 128 proximal to capsule 186 may form a rigid section.

[0068] Typically, the rigid section of a conventional delivery system lacks significant flexibility, and therefore, navigating the aortic arch 192 forces a standard rigid nosecone to twist and / or rotate relative to the first shaft as it contacts the aortic wall. As a result, the standard nosecone applies an outward force against the inner wall of the capsule as it twists and / or rotates during contact, creating separation between the capsule and the nosecone. Additionally, the rigidity of a standard nosecone within the rigid section typically requires a greater axial force to circumnavigate the aortic arch 192, thereby creating high frictional forces against the aortic wall and potentially damaging native tissue. However, the nosecone 106 disclosed herein adds bendability to the rigid section, reducing the overall length of the rigid section and limiting separation between the nosecone and the shaft, as well as the friction typically generated to navigate a delivery device around the aortic arch 192.

[0069] 14, the rigid section of the illustrated embodiment includes the length 153 of the proximal end portion 152 (see FIG. 7), the delivery capsule 186, and the rigid section of the first shaft 128, which is a region of the first shaft 128 that has low bendability and / or flexibility relative to the delivery capsule 186. By making the distal end portion 154 of the nosecone 106 pivotable (and rotatable) relative to the proximal end portion 152, the overall length of the rigid section is significantly reduced compared to conventional systems. First, for example, as shown in FIG. 14, the portion of the rigid section typically attributable to a conventional nosecone (i.e., the total length of the conventional nosecone) is reduced by approximately the entire length 155 of the distal end portion 154 (e.g., as shown in FIG. 7). This is because the distal end portion 154 is no longer rigid (ie, stationary) relative to the proximal end portion 152 and the delivery device 102 .

[0070] Second, the portion of the nosecone 106 that resides within the capsule 186 during delivery can be shorter than the corresponding portion of a standard nosecone in conventional systems. For example, conventional nosecones typically require a longer proximal portion that extends into the capsule to reduce separation between the nosecone and the capsule. In other words, due to the force that a standard nosecone applies to the inner wall of the capsule during delivery, the proximal portion of the nosecone must extend farther into the capsule to reduce gap formation. Therefore, a further reduction in the overall length of the rigid section is achieved by allowing the distal end portion 154 of the nosecone 106 to pivot and / or rotate relative to the rest of the delivery device 102. This is because the shaft length 159 of the proximal end portion 152 that extends into the delivery capsule 186 can have a shorter length than is typically necessary to prevent gap formation.

[0071] Consequently, preventing gap formation between the nosecone 106 and the capsule 186 allows the capsule 186 to remain in constant (or substantially constant) contact with the outer ridge 156 of the nosecone 106 as the delivery device is advanced around the aortic arch 192. In this manner, the nosecones 106 disclosed herein substantially prevent leakage into the delivery catheter (e.g., the first shaft 128). Additionally, as noted above, the nosecones 106 disclosed herein reduce the overall length of the rigid section, regardless of any reduction in the length of the prosthetic valve, delivery capsule, and / or the rigid first shaft.

[0072] 15-16 , the distal end portion of the delivery assembly 100 is inserted into the patient's vasculature until the capsule 186 and nosecone 106 extend through the patient's native aortic valve annulus 202 and into the left ventricle 204 of the patient's heart 188. The prosthetic valve 104 may then be deployed from the first shaft 128 of the delivery device 102 by actuating the first mechanism 136 of the handle 126, which moves the capsule 186 of the delivery device 102 proximally relative to the second shaft 130 of the delivery device 102 (and / or moves the second shaft 130 distally relative to the first shaft 128). Before or after retracting the capsule 186, the nosecone 106 may be advanced distally relative to the capsule and prosthetic valve. As explained above, the nosecone 106 may be advanced distally by actuation of the fourth mechanism 142 ( FIG. 4 ). The prosthetic valve 104 may then be radially expanded, such as by actuation of the expansion component 134 via the second mechanism 138, as previously described.

[0073] As shown in Figure 16, after the prosthetic valve 104 has been radially expanded, the prosthetic valve 104 may then be released from the delivery device 102. Thereafter, the nosecone 106 may be retracted back into the capsule 186 and / or the capsule 186 may be advanced distally back over the nosecone 106 until the end of the capsule 186 engages the ridges 156 of the nosecone, as shown in Figure 16. The delivery device 102 may then be removed from the patient's body.

[0074] Additional Examples of the Disclosed Technology In view of the above-described implementations of the disclosed subject matter, the present application discloses the following additional embodiments: It should be noted that one feature of an embodiment alone, or two or more features of that embodiment combined, and optionally two or more features of that embodiment combined with one or more features of one or more additional embodiments, are also additional embodiments that fall within the disclosure of the present application.

[0075] Example 1: A delivery apparatus for an implantable medical device, the delivery apparatus comprising: a handle; a shaft having a proximal end portion and a distal end portion, the proximal end portion coupled to the handle; and a nosecone coupled to the distal end portion of the shaft, the nosecone including the proximal end portion and the distal end portion pivotally coupled to the proximal end portion.

[0076] Example 2: The delivery device described in any example herein, especially Example 1, wherein the nosecone includes a ball and socket joint connecting the proximal end portion of the nosecone to the distal end portion of the nosecone.

[0077] Example 3: The delivery device of any example herein, especially Example 2, wherein the ball and socket joint includes a ball disposed in a socket, and one of the proximal and distal end portions includes the ball and the other of the proximal and distal end portions includes the socket.

[0078] Example 4: The delivery device of any example herein, especially Example 3, wherein the proximal end portion comprises a socket and the distal end portion comprises a ball.

[0079] Example 5: The delivery device of any example herein, especially Example 3, wherein the distal end portion comprises a socket and the proximal end portion comprises a ball.

[0080] Example 6: The delivery device of any example herein, especially Example 4, wherein the distal end portion comprises a tapered end portion, the tapered end portion being coupled to a ball.

[0081] Example 7: The delivery device of any example herein, especially Example 5, wherein the proximal end portion comprises a tapered end portion, the tapered end portion being coupled to a ball.

[0082] Example 8: The delivery device of any example herein, especially Example 6 or 7, wherein the tapered end portion has a cavity and the ball has a protrusion, the cavity being configured to receive the protrusion such that the tapered end portion is connected to the ball.

[0083] Example 9: The delivery device of any example herein, especially Example 6 or 7, wherein the ball has a cavity and the tapered end portion has a protrusion, the cavity being configured to receive the protrusion such that the ball is connected to the tapered end portion.

[0084] Example 10: The delivery device of any example herein, particularly any one of Examples 1 to 9, wherein the proximal end portion includes a first lumen and the distal end portion includes a second lumen, the first lumen and the second lumen being sized to receive a guidewire therethrough.

[0085] Example 11: The delivery device of any example herein, especially example 10, wherein the distal end portion of the shaft extends into the first lumen of the proximal end portion of the nosecone.

[0086] Example 12: The delivery device of any example herein, especially example 11, wherein the proximal end portion of the nosecone is molded or welded to the distal end portion of the shaft.

[0087] Example 13: A delivery device as described in any example herein, particularly any one of Examples 10 to 12, wherein the first lumen of the proximal end portion and the second lumen of the distal end portion each have a tapered segment, and the tapered segments of the proximal end portion and the distal end portion are adjacent to one another.

[0088] Example 14: A delivery device as described in any example herein, particularly any one of Examples 1 to 13, wherein the proximal end portion of the nosecone has a ridge extending radially outward from an outer surface of the proximal end portion.

[0089] Example 15: The delivery device of any example herein, especially example 14, wherein the ridge extends circumferentially around the outer surface of the proximal end portion.

[0090] Example 16: The delivery device of any example herein, particularly example 14 or 15, wherein the shaft includes a first shaft, the delivery device includes a second shaft extending over the first shaft, the second shaft including a delivery capsule along its distal end section, the delivery capsule configured to maintain the medical implant in a radially folded state for delivery into the patient, and the distal end section of the delivery capsule is sized to extend over the proximal end portion of the nosecone.

[0091] Example 17: A delivery device described in any example herein, particularly any one of Examples 14 to 16, wherein the distal end section of the delivery capsule abuts the ridge while extending over the proximal end portion of the nose cone.

[0092] Example 18: The delivery device of any example herein, particularly any one of Examples 1 to 17, wherein the proximal and distal end portions of the nosecone are rotatably coupled to one another.

[0093] Example 19: A delivery apparatus for an implantable medical device, the delivery apparatus comprising: a handle; a first shaft and a second shaft, the second shaft extending across the first shaft, the first shaft including a proximal end portion and a distal end portion, the proximal end portion coupled to the handle, and the second shaft including a delivery capsule along its distal end; and a nosecone coupled to the distal end portion of the first shaft, the nosecone including a proximal end portion and a distal end portion pivotally coupled to the proximal end portion by a ball and socket joint, the ball and socket joint including a ball disposed in the socket, and a nosecone, one of the proximal and distal end portions including a ball and the other of the proximal and distal end portions including a socket, wherein the proximal end portion of the nosecone includes a first lumen and the distal end portion of the nosecone includes a second lumen, the first and second lumens being sized to receive a guidewire therethrough, the distal end portion of the first shaft extending into the first lumen of the proximal end portion; and a delivery capsule configured to maintain the medical implant in a radially folded state for delivery into the patient, the distal end section of the delivery capsule being sized to extend over the proximal end portion of the nosecone.

[0094] Example 20: A delivery apparatus for an implantable medical device, the delivery apparatus comprising: a handle; a shaft having a proximal end portion and a distal end portion, the proximal end portion coupled to the handle; and a nosecone coupled to the distal end portion of the shaft, the nosecone comprising the proximal end portion and the distal end portion pivotally coupled to the proximal end portion by a ball and socket joint, the ball and socket joint comprising a ball disposed in the socket, the proximal end portion comprising the socket and the distal end portion comprising the ball.

[0095] Example 21: A delivery device as described in any example herein, especially Example 20, wherein the proximal end portion of the nosecone includes a first lumen and the distal end portion of the nosecone includes a second lumen, the first and second lumens being sized to receive a guidewire therethrough.

[0096] Example 22: A delivery device as described in any example herein, especially Example 21, wherein the distal end portion of the shaft extends into the first lumen and the proximal end portion of the nosecone, and the proximal end portion is bonded, welded, molded, or a combination thereof, to the distal end portion of the shaft.

[0097] Example 23: The delivery device of any example herein, especially Example 21 or 22, wherein the first lumen comprises a first tapered lumen and the second lumen comprises a second tapered lumen, and the first tapered lumen and the second tapered lumen are adjacent to each other and taper in opposite directions to each other.

[0098] Example 24: A delivery device as described in any example herein, especially Example 23, wherein the first and second tapered lumens are configured to allow the first and second lumens to remain in communication at all times when the proximal and distal end portions pivot relative to one another.

[0099] Example 25: The delivery device of any example herein, particularly Example 23 or 24, wherein the first lumen comprises a socket lumen, a first tapered lumen, and a shaft lumen, the socket lumen being adjacent to the first tapered lumen, and the first tapered lumen being adjacent to the shaft lumen.

[0100] Example 26: A delivery device described in any example herein, especially Example 25, wherein the socket lumen, the first tapered lumen, and the shaft lumen each comprise an inner diameter, the inner diameter of the socket lumen being greater than or equal to the inner diameter of the first tapered lumen, and the inner diameter of the first tapered lumen being greater than or equal to the inner diameter of the shaft lumen.

[0101] Example 27: The delivery device of any example herein, especially any one of Examples 23 to 25, wherein the second lumen comprises a second tapered lumen and a distal end lumen.

[0102] Example 28: A delivery device as described in any example herein, especially Example 27, wherein the distal end portion comprises a tapered portion and a ball, the tapered portion comprising a distal end lumen, and the ball comprising a second tapered lumen.

[0103] Example 29: A delivery device described in any example herein, particularly any one of Examples 25 to 28, wherein the proximal end portion includes an outer surface and a ridge, the ridge extending radially outward from the outer surface and circumferentially around the outer surface.

[0104] Example 30: The delivery device of any example herein, especially example 29, wherein the ridge is adjacent to and concentric with the socket lumen.

[0105] Example 31: A delivery apparatus for an implantable medical device, the delivery apparatus comprising: a handle; a shaft having a proximal end portion and a distal end portion, the proximal end portion coupled to the handle; and a nosecone coupled to the distal end portion of the shaft, the nosecone including the proximal end portion, the distal end portion coupled to the proximal end portion, and a coupling means for coupling the distal end portion and the proximal end portion, the coupling means allowing pivotal movement of the distal end portion relative to the proximal end portion.

[0106] Example 32: The delivery device of any example herein, especially Example 31, wherein the distal end portion includes a first lumen and the distal end portion includes a second lumen, the first lumen and the second lumen configured to receive a guidewire therethrough.

[0107] Example 33: A delivery device as described in any example herein, especially example 32, wherein the coupling means connecting the distal end portion and the proximal end portion allows for rotational movement of the distal end portion relative to the proximal end portion, such that the distal end portion is rotatable relative to the guidewire.

[0108] Example 34: The delivery device of any example herein, particularly any one of Examples 31 to 33, wherein the coupling means comprises a ball disposed in a socket, the distal end portion comprising the ball, and the proximal end portion comprising the socket.

[0109] Example 35: The delivery device of any example herein, particularly any one of Examples 31 to 34, wherein the coupling means comprises a ball disposed in a socket, the distal end portion comprising the ball, and the proximal end portion comprising the socket.

[0110] Example 36: A delivery device as described in any example herein, particularly Example 32, wherein the first lumen and the second lumen each include a tapered section, and the tapered section of the first lumen and the tapered section of the second lumen allow constant communication between the first lumen and the second lumen.

[0111] Example 37: A delivery device as described in any example herein, particularly any one of Examples 31 to 36, wherein the distal end portion includes a first section and a second section, the first section having a protrusion, and the second section having a cavity, the cavity configured to receive the protrusion, such that the first section is coupled to the second section.

[0112] Example 38: A delivery device described in any example herein, particularly any one of Examples 31 to 37, wherein the proximal end portion includes a periphery, an outer surface, and a ridge, the ridge extending outward from the outer surface and circumferentially around the periphery of the proximal end portion.

[0113] Example 39: A delivery device as described in any example herein, particularly any one of Examples 32 to 38, wherein the shaft includes a first shaft, the delivery device includes a second shaft extending over the first shaft, the second shaft including a delivery capsule along its distal end section, the delivery capsule configured to maintain the medical implant in a radially folded state for delivery into the patient, and the distal end section of the delivery capsule is sized to extend over the proximal end portion of the nose cone.

[0114] Example 40: The delivery device of any example herein, especially Example 38, wherein the ridge and first lumen are concentric about the central longitudinal axis of the proximal end portion.

[0115] Example 41: The delivery device of any example herein, especially any one of Examples 31 to 41, wherein the distal end portion has a length greater than the length of the proximal end portion.

[0116] Example 42: A delivery assembly for an implantable medical device, the delivery assembly including: a delivery apparatus including a handle, a nosecone, and a shaft, the shaft having a proximal end portion and a distal end portion, the proximal end portion coupled to the handle and the distal end portion coupled to the nosecone; and an expandable implantable medical device mounted in a radial configuration around the distal end portion of the shaft, the nosecone including a proximal end portion and a distal end portion pivotally coupled to the proximal end portion.

[0117] Example 43: A delivery assembly for an implantable medical device, the delivery assembly comprising: a delivery apparatus including a handle, a nosecone, and a shaft, the shaft having a proximal end portion and a distal end portion, the nosecone coupled to the distal end portion, the proximal end portion coupled to the handle; and an expandable implantable medical device mounted in a radial configuration around the distal end portion of the shaft, the nosecone including a proximal end portion and a distal end portion pivotally coupled to the proximal end portion by a ball and socket joint, one of the proximal and distal end portions including a ball and the other of the proximal and distal end portions including a socket.

[0118] Example 44: 1. A delivery assembly for an implantable medical device, the delivery assembly comprising: a delivery apparatus including a handle, a nosecone, a first shaft, and a second shaft, the second shaft extending over the first shaft, the first shaft including a distal end portion and a proximal end portion coupled to the handle, the second shaft including a delivery capsule along its distal end section, the nosecone including a proximal end portion and a distal end portion pivotally coupled to the proximal end portion; and an expandable implantable medical device mounted in a radially compressed configuration around the distal end portion of the first shaft and within the delivery capsule of the second shaft, the distal and proximal end portions of the nosecone pivotally coupled by a ball and socket joint, the ball and socket joint including a ball disposed in a socket, the distal end portion including the ball and the proximal end portion including the socket, the distal end section of the delivery capsule being sized to extend over the proximal end portion of the nosecone.

[0119] Example 45: A delivery assembly described in any example herein, particularly Example 44, wherein the proximal end portion of the nose cone includes an outer surface and an outer ridge, the outer ridge extending outward from the outer surface and circumferentially around the proximal end portion, and the distal end section of the delivery capsule abuts the outer ridge while extending over the proximal end portion of the nose cone.

[0120] Example 46: A delivery assembly described in any example herein, particularly Example 45, wherein the outer ridge portion includes a first outer periphery and the distal end section of the delivery capsule includes a second outer periphery, the first outer periphery being equal to or substantially equal to the second outer periphery, and wherein the outer ridge portion and the distal end section of the delivery capsule form a continuous outer surface extending from the nose cone to the handle.

[0121] Example 47: A method for delivering an implantable medical device, the method comprising: advancing an expandable implantable medical device mounted in a radially compressed configuration about a distal end portion of a shaft of a delivery device into a natural lumen of a patient, wherein at least a distal end portion of a nosecone of the delivery device is adapted to contact a wall of the patient's vasculature, and wherein contact between the nosecone and the wall of the vasculature causes the distal end portion of the nosecone to pivot relative to the proximal end portion of the nosecone.

[0122] Example 48: The method of any example herein, especially Example 47, wherein contact between the nosecone and the wall of the vasculature causes the distal end portion of the nosecone to rotate relative to the proximal end portion of the nosecone.

[0123] Example 49: A method for implanting a prosthetic valve into a patient's aortic valve annulus, the method comprising: advancing an expandable prosthetic valve and a distal end portion of a delivery device shaft into the patient's aorta, the prosthetic valve being mounted in a radially compressed configuration around the distal end portion of the shaft, at least a distal end portion of a delivery device nosecone contacting a wall of the aorta, the distal end portion of the nosecone pivotally coupled to a proximal end portion of the nosecone, the proximal end portion coupled to the distal end portion of the shaft, wherein contact between the nosecone and the wall of the aorta causes the distal end portion of the nosecone to pivot relative to the proximal end portion of the nosecone, the distal end portion of the shaft, and the prosthetic valve; inserting the distal end portion of the shaft into the patient's aortic valve annulus, the nosecone extending through the aortic valve annulus and into the patient's left ventricle; and expanding the prosthetic valve within the aortic valve annulus from the radially compressed state to a radially expanded state.

[0124] Example 50: A delivery apparatus for an implantable medical device, the delivery apparatus comprising: a handle; a first shaft and a second shaft, the second shaft extending across the first shaft, the first shaft including a proximal end portion and a distal end portion, the proximal end portion coupled to the handle, and the second shaft including a delivery capsule along its distal end; and a nosecone coupled to the distal end portion of the first shaft, the nosecone including the proximal end portion, an intermediate portion pivotally coupled to the proximal end portion by a first ball and socket joint, and a distal end portion pivotally coupled to the intermediate portion by a second ball and socket joint, each ball and socket joint including a ball disposed in a socket.

[0125] Example 51: A delivery device as described in any example herein, particularly example 50, wherein one of the proximal end portion and the intermediate portion includes a first ball and the other of the proximal end portion and the intermediate portion includes a first socket.

[0126] Example 52: A delivery device as described in any example herein, particularly example 50 or 51, wherein one of the intermediate portion and the distal end portion includes a second ball and the other of the intermediate portion and the distal end portion includes a second socket.

[0127] Example 53: The delivery device of any example herein, especially example 50, wherein the intermediate portion comprises a ball and the proximal end portion comprises a socket of a first ball and socket joint.

[0128] Example 54: The delivery device of any example herein, especially example 50 or 53, wherein the distal end portion comprises a ball and the intermediate portion comprises a socket of a second ball and socket joint.

[0129] Example 55: A delivery device as described in any example herein, particularly any one of Examples 50 to 54, wherein the proximal end portion includes a first lumen, the intermediate portion includes a second lumen, and the distal end portion includes a third lumen, and the first, second, and third lumens are sized to receive a guidewire therethrough.

[0130] Example 56: A delivery apparatus for an implantable medical device, the delivery apparatus comprising: a handle; a shaft having a proximal end portion and a distal end portion, the proximal end portion coupled to the handle; and a nosecone coupled to the distal end portion of the shaft, the nosecone including a proximal end portion and a distal end portion pivotally coupled to the proximal end portion by a plurality of ball and socket joints.

[0131] In view of the many possible embodiments to which the principles of the disclosed invention may be applied, it should be recognized that the illustrated embodiments are merely preferred examples of the invention and should not be viewed as limiting the scope of the invention. Rather, the scope of the invention is defined by the following claims. We therefore claim as our invention all that comes within the scope and spirit of these claims. [Explanation of symbols]

[0132] 100 Delivery Assembly 102 Delivery device 104 Artificial Heart Valves 106 Nosecone 108 frames 110 Valve structure 112 Commissure member 114 first end 116 Second end 118 Strut 120 aperture 122 Valve leaflets 124 Commissure 126 Handle 128 First Shaft 130 Second Shaft 132 Nose cone shaft 134 Extended Components 136 First Mechanism 138 Second Mechanism 140 Third Mechanism 142 The Fourth Mechanism 144 First Knob 146 Second Knob 148 Third Knob 150 slider 151 Tapered Section 152 proximal end portion 153 Length of proximal end portion 152 154 distal end portion 155 Overall length of distal end portion 154 156 Outer ridge 157 total length of nose cone 106 158 Opening 159 Shaft length 160 Ball and Socket Joint 161 Ball and Socket Joint 162 balls 163 Second Ball 164 sockets 165 sockets 166 First Lumen 168 Second Lumen 169 Third Lumen 170 Guidewire 172 socket lumens 174 Tapered Lumen 176 shaft lumen 178 Tapered Lumen 180 Distal End Lumen 182 Protrusion 184 Cavity 186 Delivery Capsules 188 Patient's Heart Aorta of 190 patients 192 Aortic Arch Native aortic annulus in 202 patients 204 Left ventricle

Claims

1. 1. A delivery apparatus for an implantable medical device, the delivery apparatus comprising: Handle and; a shaft having a proximal end portion and a distal end portion, the proximal end portion coupled to the handle; a nosecone coupled to the distal end portion of the shaft, the nosecone including a proximal end portion and a distal end portion pivotally coupled to the proximal end portion; Including, The shaft includes a first shaft, the delivery device includes a second shaft extending over the first shaft, the second shaft including a delivery capsule along a distal end section thereof, the delivery capsule configured to maintain the medical implant in a radially folded state for delivery into the patient.

2. The delivery device of claim 1 , wherein the nosecone includes a ball and socket joint connecting the proximal end portion of the nosecone to the distal end portion of the nosecone.

3. 3. The delivery device of claim 2, wherein the ball and socket joint includes a ball disposed in a socket, one of the proximal and distal end portions including the ball and the other of the proximal and distal end portions including the socket.

4. The delivery device of claim 3 , wherein the proximal end portion includes the socket and the distal end portion includes the ball.

5. The delivery device of claim 3 , wherein the distal end portion includes the socket and the proximal end portion includes the ball.

6. The delivery device of claim 4 , wherein the distal end portion includes a tapered end portion, the tapered end portion coupled to the ball.

7. The delivery device of claim 5 , wherein the proximal end portion includes a tapered end portion, the tapered end portion being coupled to the ball.

8. 8. The delivery device of claim 6 or 7, wherein the tapered end portion has a cavity and the ball has a protrusion, the cavity configured to receive the protrusion such that the tapered end portion is connected to the ball.

9. 8. The delivery device of claim 6 or 7, wherein the ball has a cavity and the tapered end portion has a protrusion, the cavity configured to receive the protrusion such that the ball is connected to the tapered end portion.

10. 10. The delivery device of claim 1, wherein the proximal end portion of the nosecone has a ridge extending radially outward from an outer surface of the proximal end portion.

11. The delivery device of claim 10 , wherein the ridge extends circumferentially around the outer surface of the proximal end portion.

12. A delivery device as described in claim 10 or 11, wherein the distal end section of the delivery capsule is sized to extend over the proximal end portion of the nose cone.

13. The delivery device of claim 12 , wherein the distal end section of the delivery capsule abuts the ridge while extending over the proximal end portion of the nosecone.

14. 14. The delivery device of claim 1, wherein the proximal and distal end portions of the nosecone are rotatably coupled to one another.

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