Balloon cover for delivery device for expandable prosthetic heart

Abstract

A balloon cover for a delivery device for a prosthetic valve is disclosed. As one embodiment, a balloon cover includes first and second housing members configured to matingly engage one another, each of the first and second housing members including a first portion and a second portion, the second portion having a greater width than the first portion. The first portions of the first and second housing members define a first lumen configured to receive a distal end portion of the delivery device and at least a portion of an inflatable balloon mounted on the distal end portion of the delivery device. The second portions of the first and second housing members define a second lumen configured to receive a positioning device mounted on the distal end portion of the delivery device proximal to a valve mounting portion of the distal end portion of the delivery device.

Description

[0001] This application is a divisional application of the original application which has an application date of August 23, 2021, and application number (202110965878.9), entitled “Balloon Cover for Delivery Apparatus of Expandable Prosthetic Heart Valve”.

[0002] Cross Reference to Related Applications

[0003] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 138,890, filed January 19, 2021, and also claims the benefit of U.S. Provisional Patent Application No. 63 / 069,567, filed August 24, 2020, the entire contents of which are incorporated herein by reference. TECHNICAL FIELD

[0004] The present disclosure relates to a balloon cover configured to receive a distal portion of a delivery apparatus for a balloon-expandable prosthetic heart valve. BACKGROUND

[0005] The human heart is subject to a variety of valvular diseases. These valvular diseases can cause serious malfunctions of the heart, ultimately requiring repair of the native valve or replacement of the native valve with a prosthetic valve. There are a number of known repair devices (e.g., stents) and prosthetic valves, and a number of known methods of implanting these devices and valves into the human body. Percutaneous and minimally-invasive surgical methods are used in various procedures to deliver prosthetic medical devices to locations inside the body that are not easily accessed by surgery or are desirably accessed without the need for surgery. In one particular example, a prosthetic heart valve can be mounted in a crimped state on a distal end of a delivery apparatus and advanced through the patient’s vasculature (e.g., through the femoral artery and the aorta) until the prosthetic valve reaches an implantation site in the heart. The prosthetic valve is then expanded to its functional size, e.g., by inflating a balloon on which the prosthetic valve is mounted.

[0006] The balloon cover can be configured to encase the distal portion of the delivery device including the inflatable balloon mounted thereon during shipping and / or storage prior to use and / or during a de-airing process. In some embodiments, a positioning device can be coupled to the distal portion of the delivery apparatus, which can facilitate mounting the prosthetic heart valve onto the distal portion of the delivery apparatus in a desired circumferential orientation relative to the distal portion of the delivery apparatus. However, during removal of the balloon cover, a user can inadvertently move (e.g., rotate) the positioning device relative to the delivery apparatus. As a result, the prosthetic valve can subsequently be mounted onto the balloon in an improper circumferential orientation relative to the distal portion of the delivery apparatus.

[0007] Accordingly, there is a need for improved balloon covers that prevent rotation of the positioning device relative to the delivery apparatus. SUMMARY

[0008] Embodiments of improved prosthetic valve delivery apparatus and methods for delivering a prosthetic valve to a native valve of a patient's heart and implanting the prosthetic valve at the native valve of the patient's heart with one or more selected commissures of the prosthetic valve aligned with one or more corresponding commissures of the native valve are described herein. In some embodiments, the disclosed delivery apparatus includes an inflatable balloon around which a prosthetic valve can be mounted in a radially compressed state for delivery to the native valve.

[0009] Various balloon coverings and balloon covering assemblies for such delivery devices are also described herein. In some embodiments, a balloon covering can be configured to receive a distal end portion of a delivery apparatus. In some embodiments, a balloon covering can be configured to at least partially form a particular shape of a portion of a balloon mounted on a distal end portion of a delivery apparatus.

[0010] In one representative embodiment, a balloon covering for a delivery apparatus includes a first housing member and a second housing member configured to matingly engage one another, wherein each of the first housing member and the second housing member includes a first portion and a second portion, the second portion having a greater width than the first portion, the width being defined in a direction perpendicular to a central longitudinal axis of the balloon covering. The first portion of the first housing member and the first portion of the second housing member define a first cavity configured to receive a distal end portion of the delivery apparatus and at least a portion of an inflatable balloon mounted on the distal end portion of the delivery apparatus. The second portion of the first housing member and the second portion of the second housing member define a second cavity configured to receive a positioning device mounted on the distal end portion of the delivery apparatus proximal of a valve mounting portion of the distal end portion of the delivery apparatus.

[0011] In another representative embodiment, an assembly includes a delivery apparatus including a first shaft and a second shaft, the second shaft extending through the first shaft and having a distal end portion extending distally beyond a distal end portion of the first shaft. The assembly further includes an inflatable balloon coupled to the distal end portion of the first shaft and covering a valve mounting portion of the delivery apparatus, the valve mounting portion configured to receive a prosthetic valve in a radially compressed state, a positioning device coupled to the distal end portion of the first shaft proximally of the valve mounting portion. The balloon cover includes a first housing member and a second housing member configured to matingly engage one another about the balloon and the positioning device, each of the first and second housing members including a first housing portion and a second housing portion, wherein the first housing portions of the first and second housing members define a first lumen configured to receive at least a portion of the balloon and the distal end portion of the second shaft, and wherein the second housing portions of the first and second housing members define a second lumen configured to receive the positioning device.

[0012] In another representative embodiment, a balloon cover for a delivery apparatus includes a first housing member and a second housing member configured to matingly engage one another about a distal end portion of the delivery apparatus. Each of the first and second housing members includes a first housing portion, the first housing portions of the first and second housing members defining a first lumen configured to receive at least a portion of a balloon covering a valve mounting portion of the distal end portion of the delivery apparatus. The balloon cover further includes a recessed sleeve including a first portion configured to receive and couple to the first housing portions of the first and second housing members and a second portion including one or more recessed members, each of the one or more recessed members having a free end configured to move radially inward toward a central longitudinal axis of the balloon cover. The balloon cover further includes a coupling element configured to be disposed about the second portion of the recessed sleeve and to recess the one or more recessed members radially inward such that the one or more recessed members form a negative recess in a portion of the balloon about which the recessed sleeve is disposed.

[0013] The above and other objects, features and advantages of the disclosed technology will become more apparent from the following detailed description, taken in conjunction with the accompanying drawings. BRIEF DESCRIPTION OF DRAWINGS

[0014] FIG. 1 is a perspective view of a prosthetic heart valve according to one embodiment.

[0015] FIG. 2A is a perspective view of a prosthetic heart valve according to another embodiment.

[0016] FIG. 2B is FIG. 2A is a perspective view of a prosthetic valve of

[0017] FIG. 3 is a perspective view of a delivery apparatus for a prosthetic heart valve according to one embodiment.

[0018] FIG. 4 is a schematic illustration of an exemplary heart showing the location of the coronary arteries relative to the aortic valve.

[0019] FIG. 5A illustrates an exemplary positioning of a prosthetic valve in an aortic valve relative to the coronary arteries.

[0020] FIG. 5B illustrates another exemplary positioning of a prosthetic valve in an aortic valve relative to the coronary arteries, wherein the prosthetic valve at least partially inhibits blood flow to the coronary arteries.

[0021] FIG. 6A is a cross-sectional view of an aortic valve illustrating a first positioning of a prosthetic valve within the aortic valve, wherein the commissures of the prosthetic valve at least partially block one or more openings to the coronary arteries.

[0022] FIG. 6B is a cross-sectional view of an aortic valve illustrating a second positioning of a prosthetic valve within the aortic valve, wherein the commissures of the prosthetic valve are circumferentially aligned with the native commissures of the aortic valve, thereby maintaining access to the coronary arteries.

[0023] FIG. 7 illustrates a leaflet-cutting procedure, wherein the leaflets of a native aortic valve can be split at the location of the entrance to the coronary arteries when a prosthetic heart valve is implanted within the aortic valve to enable increased blood flow into the coronary arteries.

[0024] FIG. 8A illustrates an exemplary prosthetic heart valve and an example of how splitting the native leaflets around the prosthetic heart valve at the area of the frame of the prosthetic heart valve between two adjacent commissures results in open cells in front of the entrance to the coronary arteries.

[0025] FIG. 8B illustrates FIG. 8Aan exemplary prosthetic heart valve and how splitting the native leaflets in the region of the frame of the prosthetic heart valve including the commissure does not result in open cell arrangements in front of the entrance to the coronary artery.

[0026] FIG. 9 is a side view of an embodiment of a delivery apparatus configured to deliver a radially expandable prosthetic heart valve and implant it at an implantation site.

[0027] FIG. 10 is FIG. 9 a cross-sectional side view of a distal end portion of the delivery apparatus of

[0028] FIG. 11 is FIG. 9 a side view of a distal end portion of the delivery apparatus of

[0029] FIG. 12 is FIG. 9 a schematic view of an embodiment of a middle shaft of the delivery apparatus of

[0030] FIG. 13 is FIG. 11 a cross-sectional side view of a detail portion of the coaxial shaft of the delivery apparatus of

[0031] FIG. 14 is FIG. 9 a cross-sectional side view of a handle of the delivery apparatus of

[0032] FIG. 15 is a first perspective view of an embodiment of a rotatable knob mounted on a proximal end portion of a middle shaft of a delivery apparatus, the knob being configured to rotate the middle shaft and thereby an inflatable balloon and a prosthetic heart valve radially compressed onto the balloon.

[0033] FIG. 16 is FIG. 15 a second perspective view of the knob of

[0034] FIG. 17 is FIG. 15 a cross-sectional side view of the knob of

[0035] FIG. 18 is FIG. 15 a cross-sectional view of an anchor of the knob of

[0036] FIG. 19 is FIG. 18 a perspective view of the anchor of

[0037] FIG. 20 is FIG. 15 an exploded view of an outer housing of the knob of

[0038] FIG. 21 is a side view of the anchor of FIG. 18

[0039] FIG. 22 is a side view of the anchor of FIG. 15 is a side view of the knob of

[0040] FIG. 23 is a perspective view of an embodiment of a proximal portion of a delivery device, the delivery device including a handle, a rotatable knob, and an adapter.

[0041] FIG. 24 is FIG. 23 is a perspective view of the adapter in

[0042] FIG. 25 is FIG. 24 is a cross-sectional view of the adapter of

[0043] FIG. 26 is a cross-sectional view of the adapter of FIG. 24

[0044] FIG. 27 is a detailed cross-sectional view of a portion of the adapter of FIG. 26

[0045] FIG. 28 illustrates a side view of a distal portion of a delivery device with exemplary radio-opaque markers positioned on and / or embedded within a polymer body of the distal portion of the delivery device.

[0046] FIG. 29 illustrates an exemplary fluoroscopic image of a distal portion of a delivery device of FIG. 28

[0047] FIG. 30 illustrates an embodiment of an asymmetric radio-opaque marker that allows a user to distinguish two different positions of the marker within an imaging view.

[0048] FIG. 31A is an exemplary fluoroscopic image illustrating a guidewire extending through a distal portion of a delivery device and an asymmetric marker of FIG. 30

[0049] FIG. 31B ​​​​​is an example fluoroscopy image illustrating a guidewire extending through a distal portion of a delivery device and an asymmetric marker of FIG. 30 arranged on or embedded within a portion of a distal portion of the delivery device and in a second orientation relative to the guidewire.

[0050] FIG. 32A is a side view of an example delivery device, wherein FIG. 30 the asymmetric marker of

[0051] FIG. 32B is a perspective view of an example delivery device of FIG. 32A , wherein FIG. 30 the asymmetric marker of

[0052] FIG. 33 illustrates another embodiment of an asymmetric radiopaque marker that allows a user to distinguish between two different positions of the marker within an imaging view.

[0053] FIG. 34A is an example fluoroscopy image illustrating a guidewire extending through a distal portion of a delivery device and an asymmetric marker of FIG. 33 arranged on or embedded within a portion of a distal portion of the delivery device and in a first orientation relative to the guidewire.

[0054] FIG. 34B is an example fluoroscopy image illustrating a guidewire extending through a distal portion of a delivery device and an asymmetric marker of FIG. 33 arranged on or embedded within a portion of a distal portion of the delivery device and in a second orientation relative to the guidewire.

[0055] FIG. 35A illustrates an example embodiment of a radiopaque marker attached to a commissure of a prosthetic valve in a radially compressed configuration.

[0056] FIG. 35B illustrates a prosthetic valve of FIG. 35A in a radially expanded configuration.

[0057] FIG. 35C illustrates an example prosthetic heart valve having a first attachment member arranged across a cell of the prosthetic heart valve and secured to struts forming the cell and a radiopaque marker secured to a second attachment member configured to be attached to the struts forming the cell, wherein commissure tabs of adjacent leaflets of the prosthetic heart valve are secured to the first attachment member to form a commissure.

[0058] FIG. 35D-35F A first attachment member and a second attachment member are shown attached to struts of a forming unit with the same suture.

[0059] FIG. 35G A first attachment member of a commissure is shown attached to a second attachment member in front of the commissure. FIG. 35C of a second attachment member attached to struts of a forming unit of a prosthetic valve.

[0060] FIG. 35H An inner surface of a commissure and a first attachment member attached to a forming unit of a prosthetic valve are shown.

[0061] FIG. 35I An exemplary radiopaque marker configured to be attached to a commissure within a forming unit of a prosthetic valve is shown.

[0062] FIG. 35J Another exemplary embodiment of a radiopaque marker attached to a commissure within a forming unit of a prosthetic valve is shown.

[0063] FIG. 35K Another exemplary embodiment of a radiopaque marker attached to a commissure within a forming unit of a prosthetic valve is shown.

[0064] FIG. 35L Another exemplary embodiment of a radiopaque marker attached to a commissure within a forming unit of a prosthetic valve and a radiopaque marker attached to a skirt extending through an inner surface of a frame of the prosthetic valve directly below the commissure is shown.

[0065] FIG. 35M Another exemplary embodiment of a radiopaque marker attached to a commissure within a forming unit of a prosthetic valve is shown, the prosthetic valve in a radially compressed configuration.

[0066] FIG. 35N Another exemplary embodiment of a radiopaque marker attached to a commissure within a forming unit of a prosthetic valve is shown, the prosthetic valve in a radially compressed configuration.

[0067] FIG. 35O An exemplary embodiment of a radiopaque marker attached to a first attachment member attached to a second attachment member of a commissure within a forming unit of a prosthetic valve is shown.

[0068] FIG. 35P Another exemplary embodiment of a radiopaque marker attached to a first attachment member attached to a second attachment member of a commissure within a forming unit of a prosthetic valve is shown.

[0069] FIG. 36An embodiment of an inflatable balloon folded around a distal portion of a delivery device is illustrated.

[0070] FIG. 37 A cross-sectional view of an inflatable balloon wrapped and folded around a portion of a delivery device at a valve mounting portion of the delivery device according to an embodiment.

[0071] FIG. 38 A perspective view of an embodiment of a distal tip portion of an outer shaft for a delivery device, the distal tip portion including a plurality of helical internal expansion grooves.

[0072] FIG. 39 A cross-sectional view of the distal tip portion of FIG. 38 A perspective view of the distal tip portion of

[0073] FIG. 40 A side view of a distal portion of a delivery device illustrating a radial indentation in the distal portion of an inflatable balloon of the delivery device when the distal tip portion is disposed away from a proximal portion of the balloon.

[0074] FIG. 41 A side view of a distal portion of a delivery device of FIG. 40 A side view of a distal portion of a delivery device of

[0075] FIG. 42 A side view of a distal portion of an exemplary delivery device with a prosthetic valve mounted on and around a valve mounting portion of the distal portion of the delivery device in a radially compressed state, with selected commissures of the prosthetic valve circumferentially offset from radiopaque markers on the delivery device by a predetermined amount.

[0076] FIG. 43 A rear perspective view of an exemplary embodiment of a crimping device configured to crimp a prosthetic valve onto a portion of a delivery device.

[0077] FIG. 44 A front perspective view of the crimping device of FIG. 43 A front perspective view of the crimping device of

[0078] FIG. 45 A perspective view of an embodiment of a support body of a mounting assembly configured to mount and crimp a prosthetic valve onto a delivery device in a predetermined position and / or orientation relative to the delivery device, the support body configured to hold the prosthetic valve in a radially expanded state.

[0079] FIG. 46 A front perspective view of an embodiment of a ring body configured to be coupled to FIG. 45The supporting body is used to align the prosthetic valve circumferentially on the supporting body in the desired orientation.

[0080] FIG. 47 yes FIG. 46 Rear perspective view of the ring body.

[0081] FIG. 48 Is with FIG. 45 The supporting main body is coupled FIG. 46 A perspective view of the ring-shaped main body.

[0082] FIG. 49 This is a perspective view of an embodiment of a positioning device for a mounting assembly coupled to the remote portion of a delivery device.

[0083] FIG. 50 It is installed in FIG. 45 An end view of the prosthetic valve on the supporting body, wherein the commissure is... FIG. 46 Align the corresponding indicator on the main body of the ring.

[0084] FIG. 51 This is a cross-sectional view of the installation component, which includes... FIG. 45 The supporting body and FIG. 49 The positioning device is coupled to FIG. 43 The coiling device is arranged within the coiling device such that the prosthetic valve is arranged relative to the delivery device in a predetermined orientation and / or position around the valve mounting portion of the distal portion of the delivery device.

[0085] FIG. 52 It is being used FIG. 43 A cross-sectional view of the prosthetic valve radially compressed onto the valve mounting portion of the delivery device after the curling device performs the curling operation.

[0086] FIG. 53 This is a perspective view of another embodiment of a positioning device that can be used in an assembly and coupled to a winding device.

[0087] FIG. 54 It is coupled proximally to the distal portion of the delivery device at the valve implantation site. FIG. 53 Side view of the positioning device.

[0088] FIG. 55 It is coupled to FIG. 54 The remote part of the delivery device FIG. 53 A perspective view of the positioning device.

[0089] FIG. 56 It is a flowchart of an exemplary method for rolling a prosthetic valve into a radially compressed state onto a distal portion of a delivery device at a predetermined position and orientation relative to the delivery device.

[0090] FIG. 57is a flowchart of an exemplary method for implanting a prosthetic valve at a native valve of a patient in a case where one or more selected commissures of the prosthetic valve are aligned with one or more corresponding commissures of the native valve.

[0091] FIG. 58 illustrates an exemplary fluoroscopic image of a native valve viewed with a standard tricuspid imaging view.

[0092] FIG. 59 illustrates an exemplary fluoroscopic image of a distal end portion of a delivery device including asymmetric radiopaque markers that are centered along a guide wire extending through the delivery device and appear in a forward-readable orientation, thereby indicating that the markers are directly behind the imaging view.

[0093] FIG. 60 is a schematic diagram illustrating a desired rotational positioning of a distal end portion of a delivery device including a prosthetic valve mounted thereon at a native valve, where asymmetric radiopaque markers of the delivery device are aligned with target commissures of the native valve and selected commissures of the prosthetic valve are circumferentially offset from the markers by a predetermined amount.

[0094] FIG. 61 is a schematic diagram of an embodiment of a tricuspid imaging view of a native valve that can be used to visualize a delivery device in a patient’s heart and rotationally align a prosthetic valve mounted on the delivery device during an implantation procedure.

[0095] FIG. 62 is a cross-sectional view of a native valve illustrating FIG. 61 a position of commissures of the native valve within an imaging view of

[0096] FIG. 63 is a schematic diagram of an embodiment of a right / left cusp overlap imaging view of a native valve that can be used to visualize a delivery device in a patient’s heart and rotationally align a prosthetic valve mounted on the delivery device during an implantation procedure.

[0097] FIG. 64 is a cross-sectional view of a native valve illustrating FIG. 63 a position of commissures of the native valve within an imaging view of

[0098] FIG. 65 illustrates an embodiment of an alignment ring configured to rotationally align a prosthetic valve relative to a delivery device for an implantation procedure using a first imaging view.

[0099] FIG. 66 illustrates another embodiment of an alignment ring configured to rotationally align a prosthetic valve relative to a delivery device for an implantation procedure using a second imaging view.

[0100] FIG. 67 Another embodiment of an alignment ring is illustrated, which includes multiple sets of alignment marks for use in two or more implantation procedures utilizing different selected imaging views.

[0101] FIG. 68 Another embodiment of an alignment ring including one or more sets of gradient alignment marks is illustrated.

[0102] FIG. 69 This is an exploded view of an embodiment of a balloon cover for the distal portion of a delivery device, the balloon cover being configured to cover an inflatable balloon and a positioning device mounted on the distal portion.

[0103] FIG. 70 yes FIG. 60 A perspective view of the outer shell component of the balloon cover, which is configured to engage with another outer shell component of the balloon cover to form the outer shell of the balloon cover.

[0104] FIG. 71A It includes slender protrusions. FIG. 70 A detailed view of a portion of the mating edge of the housing component.

[0105] FIG. 71B It includes elongated grooves. FIG. 70 A detailed view of another part of the mating edge of the outer shell component.

[0106] FIG. 71C When the mating edges of two shell components are joined together in an assembly structure... FIG. 60 A detailed view of a portion of the mating interface between the two outer shell components of the balloon cover.

[0107] FIG. 72 The components shown in dashed lines are those that are in the assembled configuration and are arranged inside and covered by the balloon cover. FIG. 69 First side view of the balloon cover.

[0108] FIG. 73 It is in the assembly structure FIG. 69 A second side view of the balloon cover, wherein the second side view is from FIG. 72 Rotate the first side view.

[0109] FIG. 74 It is from the proximal end of the balloon covering, in the assembled structure. FIG. 69 Perspective end view of the balloon cover.

[0110] FIG. 75A It is in the assembly structure FIG. 69A perspective view of a balloon cover, wherein a portion of the balloon cover's coverage positioning device has a wall including one or more windows configured to reduce the height of the balloon cover.

[0111] FIG. 75B yes FIG. 75A End view of the balloon cover.

[0112] FIG. 75C yes FIG. 75A Cross-sectional end view of the balloon cover.

[0113] FIG. 76A This is a perspective view of another embodiment of a balloon cover for a distal portion of a delivery device, the balloon cover being configured to cover an inflatable balloon and a positioning device mounted on the distal portion, wherein the portion of the balloon cover covering the positioning device has a wall that completely surrounds the positioning device therein.

[0114] FIG. 76B yes FIG. 76A End view of the balloon cover.

[0115] FIG. 77 This is an exploded view of another embodiment of a balloon cover for the distal portion of a delivery device, the balloon cover being configured to cover an inflatable balloon and a positioning device mounted on the distal portion, and producing a specified final shape for the inflatable balloon.

[0116] FIG. 78 yes FIG. 77 A perspective view of a recessed sleeve of a balloon cover, the recessed sleeve comprising one or more recessed members.

[0117] FIG. 79 yes FIG. 78 End view of the recessed sleeve.

[0118] FIG. 80 yes FIG. 78 Another perspective view of the recessed sleeve.

[0119] FIG. 81A It is in a non-flexible or static structure. FIG. 78 A cross-sectional side view of the recessed sleeve.

[0120] FIG. 81B It is in a flexural or radially inward structure. FIG. 78 A cross-sectional side view of the recessed sleeve.

[0121] FIG. 82 It was removed from the rest of the balloon cover. FIG. 77 A perspective view of the outer shell components of the balloon cover.

[0122] FIG. 83A yesFIG. 77 is a first cross-sectional side view of an assembled balloon cover of

[0123] FIG. 83B is a second cross-sectional side view of an assembled balloon cover of FIG. 77

[0124] FIG. 84 is a plan view of another exemplary embodiment of a housing member for a balloon cover configured to receive a portion of a distal end portion of a delivery apparatus including an inflatable balloon and a positioning device mounted thereon and to form a designated final shape of the balloon around the delivery apparatus.

[0125] FIG. 85 is a perspective view of the housing member of FIG. 84

[0126] is a cross-sectional side view of the housing member of FIG. 86 FIG. 84

[0127] FIG. 87A is a perspective view of a shaft connector release assembly coupling a proximal end portion of a rotatable shaft of a delivery apparatus to an adapter.

[0128] FIG. 87B is a cross-sectional view of the shaft connector release assembly of FIG. 87A

[0129] is an exploded view of the shaft connector release assembly of FIG. 88 FIG. 87A is a perspective view of the shaft connector release assembly of

[0130] FIG. 89 FIG. 87A is a perspective view of the shaft connector release assembly of

[0131] FIG. 90 is an exploded view of the shaft connector release assembly of FIG. 89

[0132] is a perspective view of an embodiment of a release sleeve of the shaft connector release sleeve of FIG. 91 FIG. 89 is a side view of the release sleeve of

[0133] FIG. 92 FIG. 91 is a cross-sectional side view of the release sleeve of

[0134] FIG. 93 is a cross-sectional side view of the release sleeve of FIG. 92

[0135] is a cross-sectional side view of the release sleeve of FIG. 94 FIG. 89 ​​​​​​​​Perspective view of an embodiment of an adapter insert of an axle connector release assembly.

[0136] FIG. 95 is FIG. 94 Side view of an adapter insert.

[0137] FIG. 96 is FIG. 95 Cross-sectional side view of an adapter insert.

[0138] FIG. 97 An exemplary radiopaque marker is shown stitched to a central portion of an attachment member configured to form a coaptation with a coaptation tab of an adjacent leaflet of a prosthetic heart valve and configured to be arranged across a cell of the prosthetic heart valve and secured to struts forming the cell.

[0139] FIG. 98A A marker secured to an outer surface of an attachment member of FIG. 97 and a coaptation tab secured to an inner surface of the attachment member are shown.

[0140] FIG. 98B An attachment member of FIG. 98A of a cell secured to a strut of the cell and a marker facing away from the coaptation are shown.

[0141] FIG. 99A A marker secured to an inner surface of an attachment member of FIG. 97 and a coaptation tab secured to an inner surface of the attachment member are shown.

[0142] FIG. 99B An attachment member of FIG. 99B of a cell secured to a strut of the cell and a marker facing towards the coaptation are shown.

[0143] FIG. 100 An exemplary embodiment of a marker positioned against an elongated flap of an attachment member configured to form a coaptation with a coaptation tab of an adjacent leaflet of a prosthetic heart valve and configured to be arranged across a cell of the prosthetic heart valve and secured to struts forming the cell is shown.

[0144] FIG. 101A-101E A process of stitching a marker to an attachment member of FIG. 100 using one or more fasteners for securing a coaptation tab of a leaflet to the attachment member is shown.

[0145] FIG. 102 is a perspective view of another embodiment of a rotatable knob mounted on a proximal portion of an intermediate shaft of a delivery apparatus, the knob configured to rotate the intermediate shaft, thereby rotating an inflatable balloon and a prosthetic heart valve radially compressed onto the balloon.

[0146] FIG. 103is a side view of the knob of FIG. 102

[0147] FIG. 104 is a first exploded view of the knob of FIG. 102

[0148] FIG. 105 is a second exploded view of the knob of FIG. 102

[0149] FIG. 106 is a first cross-sectional side view of the knob of FIG. 102

[0150] FIG. 107 is a second cross-sectional side view of the knob of FIG. 102

[0151] FIG. 108 is a perspective view of another embodiment of a balloon cover for a distal portion of a delivery device, the balloon cover configured to cover an inflatable balloon and a positioning device mounted on the distal portion.

[0152] FIG. 109 is a side view of the balloon cover of FIG. 108

[0153] FIG. 110 is an exploded view of the balloon cover of FIG. 108

[0154] FIG. 111 is another side view of the balloon cover of FIG. 108

[0155] FIG. 112 is another side view of the balloon cover of FIG. 111

[0156] FIG. 113 is a cross-sectional perspective view of the balloon cover of FIG. 108

[0157] FIG. 114 is a partial cross-sectional side view of the balloon cover of FIG. 108 DETAILED DESCRIPTION

[0158] It is generally contemplated ​​​​​​​​​​​

[0159] For purposes of this description, certain aspects, advantages, and novel features of the embodiments of the present disclosure are described herein. The methods, systems, and devices 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 sub-combinations with one another. The methods, systems, and devices of the present disclosure are not limited to any specific aspect, feature, or combination of parts thereof, nor do the methods, systems, and devices require that any one or more specific advantages be present or problems be solved.

[0160] Features, integers, characteristics, compounds, chemical moieties, or groups described in conjunction with a particular aspect, embodiment or example of the present disclosure are to be understood to be applicable to any other aspect, embodiment or example described herein unless incompatible therewith. All

[0161] Although some of the operations of methods of the present disclosure are described in a particular, sequential order for convenience only, it is to be understood that deeper arrangements can be made, unless a particular order is specified by language such as first, then, after, or the like. For example, operations described sequentially can in some cases be rearranged or performed concurrently. Moreover, for the sake of simplicity, the attached drawings can not show the various ways in which the methods, systems, and devices of the present disclosure can be used in conjunction with other systems, methods, and devices.

[0162] As used herein, the terms "one," "a," and "at least one" include one or more of the specified element. That is, if there are two of the specified elements, then "one" or "at least one" of the elements exists, and there are two of the elements. The terms "plurality" and "a plurality" mean two or more of the specified element.

[0163] As used herein, the term "and / or," when used between the last two of a list of elements, means that any one or more of the listed elements can be present. For example, the phrase "A, B, and / or C" means "A," "B," "C," "A and B," "A and C," "B and C," or "A, B, and C."

[0164] As used herein, the term "coupled" generally means physically coupled or linked, and does not exclude the presence of intermediate elements between the coupled items in the absence of a particular contrary language.

[0165] Directions and other relative references (e.g., inner, outer, upper, lower, etc.) can be used to facilitate the discussion of the drawings and principles herein, but are not intended to be limiting. For example, certain terms such as "inboard," "outboard," "top," "down," "interior," "exterior," and the like can be used. Such terms, when applicable, are used to provide some clarity of description when dealing with relative relationships, especially with respect to the illustrated embodiments. However, such terms are not intended to imply absolute relationships, positions, and / or orientations. For example, "upper" can become "lower" simply by turning an object over. However, it is still the same part, and the object is still the same. As used herein, "and / or" means "and" or "or", as well as "and" and "or".

[0166] As used herein with reference to prosthetic heart valves and delivery devices, "proximal" refers to the position, orientation, or portion of a component of a delivery device handle that is closer to a user and / or outside of a patient, while "distal" refers to the position, orientation, or portion of a component that is further from the user and / or the delivery device handle and closer to an implantation site. The terms "longitudinal" and "axial" refer to an axis that extends in the proximal and distal directions, unless explicitly defined otherwise. Additionally, the term "radial" refers to a direction that is arranged perpendicular to an axis and along a radius from a center of a point of an object (where the axis is positioned at the center, such as a longitudinal axis of a prosthetic valve).

[0167] Examples of the disclosed technology

[0168] Examples of prosthetic valve delivery devices and methods for delivering a radially expandable prosthetic valve and implanting it at a native valve of a heart such that commissure portions of the prosthetic valve are circumferentially aligned within commissure portions of the native valve are described herein.

[0169] Examples of balloon coverings configured to receive a distal end portion of a delivery device therein are also described herein. In some embodiments, such balloon coverings can be configured to produce a specified shape of an inflatable balloon that covers a portion of the distal end portion of the delivery device.

[0170] Assemblies for coupling a rotatable shaft of a delivery device to an adapter of the delivery device that is configured to receive an inflation fluid for an inflatable balloon of the delivery device are also described herein.

[0171] In some embodiments, a delivery apparatus can include a first shaft configured to rotate about a central longitudinal axis of the delivery apparatus to rotationally align a prosthetic valve mounted on the delivery apparatus with native anatomy at a target implant site. The delivery apparatus can further include a second shaft extending through the first shaft and having a distal end portion extending distally beyond a distal end portion of the first shaft. In some embodiments, one or more polymeric bodies, such as one or more balloon shoulders and / or nose cones, can be mounted on the distal end portion of the second shaft. The delivery apparatus can further include an inflatable balloon coupled to the distal end portion of the first shaft. In some embodiments, a shoulder or another polymeric body of the delivery apparatus can be disposed within the balloon, and radiopaque markers can be mounted on or embedded within the shoulder at locations spaced radially outward from an outer surface of the distal end portion of the second shaft. The markers can be asymmetrically reflective along an axis parallel to the central longitudinal axis of the delivery apparatus. The shoulder can be configured such that, when the prosthetic valve is mounted on the balloon in a radially compressed state, the shoulder prevents movement of the prosthetic valve relative to the balloon in an axial direction.

[0172] In this manner, the delivery apparatus can be configured to rotationally align a radially compressed prosthetic valve at a native valve such that the prosthetic valve is implanted with commissures of the prosthetic valve aligned (e.g., circumferentially aligned) with commissures of the native valve. For example, rotating the first shaft can cause rotation of the balloon and the radially compressed prosthetic valve mounted thereon. In some embodiments, the first shaft can be rotated at or near the native valve until the markers on the shoulder or alternative polymeric body of the delivery apparatus are aligned with desired landmarks of the native anatomy and / or a guidewire within a selected imaging view.

[0173] The prosthetic valves disclosed herein can be radially compressed and expanded between a radially compressed configuration and a radially expanded configuration. Thus, the prosthetic valves can be crimped on a delivery apparatus in the radially compressed configuration during delivery and then expanded to the radially expanded configuration once the prosthetic valve reaches the implant site. In some embodiments, the prosthetic valve can be deployed at the implant site (e.g., a native valve of a heart) from the delivery apparatus via inflating an inflatable balloon of the delivery apparatus.

[0174] FIG. 1A prosthetic heart valve (e.g., a prosthetic valve) 10 according to one embodiment is shown. The illustrated prosthetic valve is adapted for implantation into a native aortic annulus, but in other embodiments it can be adapted for implantation into other native annuli of the heart (e.g., the pulmonary valve, the mitral valve, and the tricuspid valve). The prosthetic valve can also be adapted for implantation into other tubular organs or passageways in the body. The prosthetic valve 10 can have four main components: a stent or frame 12, a valve structure 14, an inner skirt 16, and a paravalvular outer sealing member or outer skirt 18. The prosthetic valve 10 can have an inflow end portion 15, an intermediate portion 17, and an outflow end portion 19.

[0175] The valve structure 14 can include three leaflets 40 that collectively form a leaflet structure, which can be arranged to collapse in a tricuspid arrangement, although in other embodiments there can be a greater or lesser number of leaflets (e.g., one or more leaflets 40). The leaflets 40 can be secured to one another at their adjacent sides to form commissures 22 of the valve (e.g., leaflet) structure 14. The lower edge of the valve structure 14 can have a wavy, curved scalloped shape and can be secured to the inner skirt 16 by sutures (not shown). In some embodiments, the leaflets 40 can be formed of pericardial tissue (e.g., bovine pericardial tissue), a biocompatible synthetic material, or various other suitable native or synthetic materials known in the art and described in U.S. Patent No. 6,730,118, which is incorporated herein by reference.

[0176] The frame 12, or components thereof (e.g., struts and / or fasteners), can be fabricated from any of a variety of suitable plastically-expandable materials (e.g., stainless steel, etc.) or self-expanding materials (e.g., nickel-titanium alloy (NiTi), such as Nitinol) as known in the art. When fabricated from a plastically-expandable material, the frame 12 (and thus the prosthetic valve 10) can be crimped to a radially collapsed configuration on a delivery catheter and then expanded within the patient by an inflatable balloon or comparable expansion mechanism. When fabricated from a self-expanding material, the frame 12 (and thus the prosthetic valve 10) can be crimped to a radially collapsed configuration and restrained in the collapsed configuration by insertion within a sheath tube or comparable mechanism of a delivery catheter. Once inside the body, the prosthetic valve can be advanced from the delivery sheath tube, which allows the prosthetic valve to expand to its functional size.

[0177] Suitable plastically-expandable materials that can be used to form the frame 12 include, but are not limited to, stainless steel, biocompatible, high-strength alloys (e.g., cobalt-chrome or nickel-cobalt-chrome alloys), polymers, or combinations thereof. In particular embodiments, the frame 12 is fabricated from a nickel-cobalt-chrome-molybdenum alloy, such as MP35N®. L605 alloy (SPS Technologies, Jenkintown, Pennsylvania), which is equivalent to (covered by ASTM F562-02) UNS R30035 alloy. By weight, The L605 / UNS R30035 alloy includes 35% nickel, 35% cobalt, 20% chromium, and 10% molybdenum. Additional details regarding the prosthetic valve 10 and its various components are described in WIPO Patent Application Publication No. WO 2018 / 222799, which is incorporated herein by reference.

[0178] FIG. 2A is a perspective view of a prosthetic heart valve 50 according to another embodiment. The prosthetic valve 50 can have three main components: a stent or frame 52, a valve structure 54, and a sealing member 56. FIG. 2B is a perspective view of the prosthetic valve 50, with components on the outer side of the frame 52 (including the sealing member 56) shown in transparent lines for illustration purposes.

[0179] As with the valve-like structure 14 of FIG. 1 The valve-like structure 54 can include three leaflets 60 that collectively form a leaflet structure that can be arranged to collapse in a tricuspid arrangement. Each leaflet 60 can be coupled to the frame 52 along its inflow edge 62 (lower edge in the figure, also referred to as a “tip edge”) and at a commissure 64 of the valve structure 54 where adjacent portions of two leaflets (e.g., commissure tabs) are connected to each other. In some embodiments, the commissure 64 can include an attachment member (e.g., including fabric, flexible polymer, etc.) arranged across a cell (e.g., a commissure cell) of the frame 52, which is formed by struts of the frame. The attachment member can be secured to the struts of the frame forming the cell, and the adjacent portions of two leaflets can be connected to the attachment member to form the commissure 64 (e.g., as shown in FIG. 16 and 17 as further described below).

[0180] A reinforcing element (not shown), such as a fabric strip, can be directly connected to the tip edge of the leaflet and to the strut of the frame to couple the tip edge of the leaflet to the frame.

[0181] Similar to FIG. 1The frame 52 can be made of any of a variety of suitable malleable or self-expanding materials known in the art and described above. In the illustrated embodiment, the frame 52 includes a plurality of circumferentially extending rows of angled struts 72 that define rows of cells or openings 74 of the frame. The frame 52 can have a cylindrical or substantially cylindrical shape with a constant diameter from the inflow end 66 to the outflow end 68 of the frame, as shown, or the diameter of the frame can vary along the height of the frame, as disclosed in U.S. Patent Publication No. 2012 / 0239142, which is incorporated by reference herein.

[0182] The frame 52 can include a plurality of vertices 80 spaced apart from one another around the circumference of the frame 52 at each of the inflow end 66 and the outflow end 68.

[0183] In the illustrated embodiment, the sealing member 56 is mounted on the outside of the frame 52 and is configured to form a seal against surrounding tissue (e.g., native leaflets and / or the native annulus) to prevent or at least minimize paravalvular leakage. The sealing member 56 can include an inner layer 76 (which can be in contact with the outer surface of the frame 52) and an outer layer 78. The sealing member 56 can be connected to the frame 52 using suitable techniques or mechanisms. For example, the sealing member 56 can be sutured to the frame 52 via sutures that can extend around the struts 72 and through the inner layer 76. In alternative embodiments, the inner layer 76 can be mounted on the inner surface of the frame 52, while the outer layer 78 is on the outside of the frame 52.

[0184] The outer layer 78 can be configured or shaped to extend radially outward from the inner layer 76 and the frame 52 when the prosthetic valve 50 is deployed. The outer layer 78 can expand away from the inner layer 76 to create a space between the two layers when the prosthetic valve is fully expanded outside of the patient’s body. This therefore allows the outer layer 78 to expand into contact with surrounding tissue when implanted inside the body.

[0185] Additional details regarding the prosthetic valve 50 and its various components are described in U.S. Patent Publication No. 2018 / 0028310, which is incorporated by reference herein.

[0186] FIG. 3 A delivery device (e.g., apparatus) 100 that can be used to implant an expandable prosthetic heart valve (e.g., the prosthetic valve 10 or 50) or another type of expandable prosthetic medical device, such as a stent, in accordance with an embodiment is shown. In some embodiments, the delivery device 100 is particularly suitable for use in introducing a prosthetic valve into the heart.

[0187] In FIG. 3In the illustrated embodiment, the delivery device 100 is a balloon catheter that includes a handle 102, a steerable outer shaft 104 extending from the handle 102, an intermediate shaft extending coaxially from the handle 102 through the steerable outer shaft 104, and an inner shaft 106 extending coaxially from the handle 102 through the intermediate shaft and the steerable outer shaft 104, an inflatable balloon (e.g., a balloon) 108 extending from a distal end of the intermediate shaft, and a nosecone 110 disposed at a distal end of the delivery device 100. A distal end portion 112 of the delivery device 100 includes the balloon 108, the nosecone 110, and a balloon shoulder assembly. A prosthetic medical device, such as a prosthetic heart valve, can be mounted on a valve holding portion of the balloon 108, as described further below with reference to FIG. 9-11 , 41 and 42. As described further below, the balloon shoulder assembly is configured to hold the prosthetic heart valve or other medical device at a fixed position on the balloon 108 during delivery through a patient’s vasculature. In some embodiments, the balloon shoulder assembly can include a proximal shoulder 120 and / or a distal shoulder 122.

[0188] The handle 102 can include a steering mechanism configured to adjust the curvature of the distal end portion of the delivery device. In the illustrated embodiment, for example, the handle 102 includes an adjustment member, such as the illustrated rotatable knob 134, which in turn is operably coupled to a proximal end portion of a pull wire (not shown). The pull wire extends distally from the handle 102 through the outer shaft 104 and has a distal end portion attached to the outer shaft at or near a distal end of the outer shaft 104. Rotating the knob 134 effectively increases or decreases tension in the pull wire, thereby adjusting the curvature of the distal end portion of the delivery device.

[0189] In some embodiments, the delivery apparatus (or another similar delivery apparatus) can be configured to deploy and implant a prosthetic heart valve (e.g., FIG. 1 the prosthetic valve 10 of FIG. 2A and 2B the prosthetic heart valve 50 of FIG. 4 In some embodiments, the delivery apparatus (or another similar delivery apparatus) can be configured to deploy and implant a prosthetic heart valve (e.g., FIG. 4 The example heart 200 includes an aortic valve 202. As shown in

[0190] As shown in FIG. 5AAs shown, because the prosthetic heart valve 206 is implanted in the native aortic valve annulus of the aortic valve 202, blood flow 208 can exit the prosthetic heart valve 206, flow into the aorta 205, and then flow over the top of the outflow end of the prosthetic heart valve 206 and / or through open cells in the frame of the prosthetic heart valve 206 (e.g., open cells that are not constantly covered by the leaflets of the prosthetic heart valve) to the coronary arteries 204 (only one of which is illustrated in FIG. 5A and 5B ). Depending on the patient’s anatomy, the prosthetic heart valve can cover at least a portion of the openings to the coronary arteries 204 (e.g., be placed in front of them), as shown in the example depicted in FIG. 5B . When the commissures 210 of the prosthetic heart valve 206 are arranged in front of (e.g., adjacent to) the openings to one of the coronary arteries 204, the interference with blood flow to the coronary arteries 204 can be further exacerbated ( FIG. 5B ). For example, because the adjacent leaflets are coupled together at the commissures 210, the commissures 210 block and / or reduce blood flow through the cells to which they are coupled. Thus, less oxygenated blood can reach the coronary arteries and the heart muscle.

[0191] Accordingly, rather than deploying the prosthetic heart valve with a random rotational orientation relative to the aorta 205, which can result in the commissures 210 of the prosthetic heart valve 206 being arranged in front of the coronary arteries 204 (as shown in FIG. 6A ), it can be desirable to deploy the prosthetic heart valve 206 in a target rotational orientation in which the commissures 210 are positioned away from the coronary arteries 204 and do not block the coronary arteries 204 (as shown in FIG. 6B ). For example, as shown in FIG. 6B , the delivery device can be configured to deploy the prosthetic heart valve 206 such that the commissures 210 of the radially expanded prosthetic heart valve 206 are circumferentially aligned with the native commissures 212 of the aortic valve 202.

[0192] As explained further below, the delivery device can be configured to control the rotational positioning of the prosthetic heart valve 206 relative to the native valve to achieve commissure alignment as shown in the example of FIG. 6B , thereby increasing blood flow to the coronary arteries 204. Additionally, this positioning of the prosthetic heart valve can facilitate a later leaflet-cut procedure to provide increased blood flow to the coronary arteries, as shown in the example of FIG. 7-8B .

[0193] For example, as shown in FIG. 7As shown, the native leaflets 214 of the native valve (e.g., aortic valve 202) can be longitudinally split (e.g., cut) at the entrance location of the coronary artery 204 (relative to the central longitudinal axis of the prosthetic heart valve 206). This allows increased blood flow from the aorta into the coronary artery 204 through one or more open (e.g., not covered by leaflets) units 216 of the prosthetic heart valve 206.

[0194] like FIG. 8A As shown, the primary leaflet 214 splits in the region between two adjacent commissures 210 within the framework of the prosthetic heart valve 206. FIG. 8A and 8B The diagram shows an open unit 216 surrounding the prosthetic heart valve 206, which allows blood flow to be received through it. However, as... FIG. 8B As shown, splitting the native leaflet 214 in the region including the commissure 210 within the framework of the prosthetic heart valve 206 (e.g., since the commissure 210 is positioned anterior to the entrance to the coronary artery 204) does not result in the opening unit 216 being arranged anterior to the entrance to the coronary artery 204. Alternatively, the commissure 210 may continue to obstruct blood flow to the coronary artery 204.

[0195] Therefore, there is a need for delivery devices and methods for deploying a radially expandable prosthetic heart valve relative to the native valve in a desired rotational orientation such that the prosthetic heart valve suture is aligned with the native valve suture.

[0196] FIG. 9-68 Embodiments of a delivery device, method, and related components are shown for implanting a radially expandable prosthetic heart valve into a native valve using a delivery device, such that the commissure of the prosthetic heart valve is aligned with the commissure of the native valve. In some embodiments, the prosthetic valve and the delivery device are configured such that the prosthetic valve is deployed from the delivery device to the native valve by inflating a balloon of the delivery device.

[0197] FIG. 9-14 The illustration depicts a retractable prosthetic heart valve (e.g., according to an embodiment) that can be used for implantation. FIG. 1 10 or more prosthetic valves FIG. 2A-2B Delivery device 300 for a prosthetic valve 50 or another type of scalable prosthetic medical device (such as a stent). In some embodiments, delivery device 300 is particularly suitable for introducing a prosthetic valve into the heart. As further described below, delivery device 300 can be configured to rotate at the target implantation site (e.g., at the native valve of the heart) to a radially compressed state on the delivery device to achieve alignment of the suture between the native valve and the prosthetic valve after deployment of the prosthetic valve.

[0198] Similar to FIG. 3Delivery device 100, delivery device 300 is a balloon catheter including a handle 302 and a steerable outer shaft 304 extending distally from handle 302 FIG. 9 and 14 Delivery device 300 can further include an intermediate shaft 306 (which can also be referred to as a balloon shaft) extending proximally from handle 302 FIG. 9 and 14 and distally from handle 302, the portion extending distally from handle 302 also extending coaxially through outer shaft 304. Additionally, delivery device 300 can further include an inner shaft 308 extending distally from handle 302, coaxially through intermediate shaft 306 and outer shaft 304 (as shown in detail portion 355 in FIG. 13 and extending proximally from handle 302, coaxially through intermediate shaft 306.

[0199] As further described below, outer shaft 304 and intermediate shaft 306 are configured to longitudinally translate (e.g., move) relative to one another along a central longitudinal axis 320 in order to facilitate delivery and positioning of a prosthetic valve at an implant site in a patient’s body.

[0200] Intermediate shaft 306 can include a proximal end portion 310 extending proximally from a proximal end of handle 302 to a proximal end of adapter 312 FIG. 9 and 14 A rotatable knob 314 can be mounted on proximal end portion 310 FIG. 9 and 14 and can be configured to rotate intermediate shaft 306 about central longitudinal axis 320 of delivery device 300 and relative to outer shaft 304, as further described below with reference to FIG. 15-22

[0201] Adapter 312 can include a first port 338 configured to receive a guidewire therethrough and a second port 340 configured to receive a fluid (e.g., inflation fluid) from a fluid source. Second port 340 can be fluidly coupled to an inner lumen of intermediate shaft 306, as further described below.

[0202] Intermediate shaft 306 can further include a distal end portion 316 extending distally beyond a distal end of outer shaft 304 FIG. 10 and 11 when a distal end of outer shaft 304 is positioned away from an inflatable balloon 318 of delivery device (e.g., as further described below with reference to FIG. 38-41 A distal end portion of inner shaft 308 can extend distally beyond distal end portion 316 of intermediate shaft 306 FIG. 10

[0203] ​​The balloon 318 is coupled to the distal portion 316 of the intermediate shaft 306. For example, in some embodiments, the proximal portion of the balloon 318 is coupled to the distal end 348 of the intermediate shaft 306 and / or coupled around the distal end 348 of the intermediate shaft 306. FIG. 10 and 11 ).

[0204] The balloon 318 may include a distal portion (or segment) 332, a proximal portion (or segment) 333, and a middle portion (or segment) 335, the middle portion 335 being disposed between the distal portion 332 and the proximal portion 333.

[0205] In some embodiments, the distal end of the distal portion 332 of the balloon 318 may be coupled to the distal end of the delivery device 300, such as to the nasal cone 322 (e.g., FIG. 9-11 (as shown), or an alternative component coupled to the distal end of the delivery device 300 (e.g., the distal shoulder). In some embodiments, the intermediate portion 335 of the balloon 318 may cover the valve mounting portion 324 of the distal portion 309 of the delivery device 300, the distal portion 332 may cover the distal shoulder 326 of the delivery device 300, and the proximal portion 333 may surround a portion of the inner axis 308 (as shown). FIG. 10 The valve mounting portion 324 and intermediate portion 335 of the capsule 318 can be configured to receive a prosthetic heart valve in a radially compressed state (e.g., as shown in the image). FIG. 41 and 42 As shown, as further described below).

[0206] As further described below, rotation of the intermediate axis 306 causes rotation of the balloon 318 and the prosthetic valve mounted thereon, so as to rotate the prosthetic valve relative to the native anatomical structures at the target implantation site.

[0207] The balloon shoulder assembly is configured to maintain a prosthetic heart valve or other medical device in a fixed position on balloon 318 during delivery through the patient's vascular system. The balloon shoulder assembly may include a distal shoulder 326 disposed within the distal portion of balloon 318 and coupled to the distal portion of the inner shaft 308. FIG. 9-11 The distal shoulder 326 can be configured to prevent the prosthetic valve or other medical device mounted on the valve mounting portion 324 from moving distally relative to the balloon 318 in the axial direction (e.g., along the central longitudinal axis 320).

[0208] For example, in some embodiments, the distal shoulder 326 may include a flared portion 331 arranged adjacent to the valve mounting portion 324. FIG. 10 In some embodiments, the flared portion 331 may include a portion extending from the distal shoulder 326. FIG. 10The base (e.g., shaft) portion 325 of the valve mount portion 324 has a plurality of wings 330 that flare outwardly toward the valve mount portion 324 (see below). FIG. 28 , 32A -32B and 40-42 are discussed in more detail.

[0209] The outer shaft 304 may include a distal tip portion 328 mounted on its distal end. FIG. 9 and 11 In some embodiments, the distal tip portion 328 may be configured as a flexural adapter including a plurality of inner and outer helical grooves, as referenced below. FIG. 38-41 Further described. When the prosthetic valve is mounted on the valve mounting portion 324 in a radially compressed state and during delivery of the prosthetic valve to the target implantation site (e.g., as described above). FIG. 41 As shown, the outer axis 304 and the intermediate axis 306 can be axially translated relative to each other to position the distal tip portion 328 proximally adjacent to the valve mounting portion 324. Therefore, the distal tip portion 328 can be configured to prevent the prosthetic valve from moving proximally relative to the balloon 318 in the axial direction when the distal tip portion 328 is positioned proximally adjacent to the valve mounting portion 324.

[0210] In some embodiments, the nose cone 322 may be disposed on the distal side of the distal shoulder 326 and coupled to the distal shoulder 326. In some embodiments, the nose cone 322 may be coupled to the distal portion of the inner shaft 308.

[0211] In some embodiments, the delivery device 300 may include one or more marks or marking strips 353 configured to indicate the location of a designated component of the delivery device to a user. In some embodiments, the one or more marking strips 353 may be non-transparent. In some embodiments, the one or more marking strips 353 may be radially compressed (e.g., curled) onto the inner shaft 308. FIG. 10 and 11 And also FIG. 32A and 40 (as shown in the image).

[0212] like FIG. 10 As shown, the distal portion 332 of the balloon 318 may include a radial recess 334 that is recessed inward toward the central longitudinal axis 320 relative to the outermost radial surface of the distal shoulder 326 and the outermost radial surface of the nasal cone 322. See below for reference. FIG. 40 and 41 The radial recess 334 is described in further detail.

[0213] like FIG. 13 Selected portion 355 of delivery device 300 (from FIG. 11As shown in a detailed cross-sectional view, an annular space 336 may be defined between the outer surface of the inner shaft 308 and the inner surface of the intermediate shaft 306. In some embodiments, the annular space 336 may be referred to as the inner lumen of the intermediate shaft 306. In some embodiments, the annular space 336 may be configured to receive fluid from a fluid source via a second port 340 of the adapter 312 (e.g., the annular space 336 is in fluid communication with the second port 340 of the adapter 312). The annular space 336 may be fluidly coupled to a fluid channel 342 formed between the outer surface of the distal portion of the inner shaft 308 and the inner surface of the balloon 318. FIG. 10 Therefore, fluid from the fluid source can flow from the annular space 336 to the fluid channel 342 to inflate the balloon 318 and radially expand and deploy the prosthetic valve.

[0214] Inner shaft 308 ( FIG. 13 The inner lumen 344 of the delivery device 300 can be configured to receive a guidewire passing through it, in order to navigate the distal portion 309 of the delivery device 300 to the target implantation site. As described above, the first port 338 of the adapter 312 can be coupled to the inner lumen 344 and configured to receive the guidewire. For example, the distal portion 309 of the delivery device 300 can be advanced over the guidewire to the target implantation site. FIG. 29 , 31A Exemplary guidewires are shown in -31B, 34A-34B and 59, as further described below.

[0215] like FIG. 12 A schematic diagram of the intermediate shaft 306 and FIG. 13 Selected portion 355 of delivery device 300 in FIG. 11 As shown in the detailed cross-sectional view, in some embodiments, the intermediate (e.g., balloon) shaft 306 may include two layers of braided (or coiled) material configured to increase the torque resistance of the intermediate shaft 306 so that it can withstand rotation at the target implantation site. The braided or coiled material may include a more rigid braided or coiled material, such as metal or polyethylene terephthalate (PET).

[0216] For example, the intermediate shaft 306 may break in a first portion 346 having a first length 356 and a second portion 354 having a second length 358, the first length 356 being longer than the second length 358. FIG. 12 The first length 356 may be a majority of the total length of the intermediate shaft 306. In some embodiments, the second length 358 may be in the range of 4 to 10 inches, 4 to 8 inches, or 5 to 7 inches. In some embodiments, the second length 358 may be approximately 6 inches. Thus, the first portion 346 may extend a distance (e.g., the second length 358) from the proximal portion 310 of the intermediate shaft 306 away from the distal end 348 of the intermediate shaft 306.

[0217] The two layers of braided material of the intermediate shaft 306 may include the entire length of the intermediate shaft 306 (up to the distal end 348) (along both the first portion 346 and the second portion 354). FIG. 13 The first braided layer 350 extends from the intermediate shaft 306. The two layers of braided material can further include those along the first portion 346. FIG. 13 The second braided layer 352 extends for most of the length of the intermediate shaft 306. However, the second braided layer 352 stops before the second section 354. FIG. 12 and 13 This allows the distal second portion 354 of the intermediate shaft 306 to have increased flexibility at the distal portion 316.

[0218] In an alternative embodiment, the second braided layer 352 may extend the entire length of the intermediate shaft 306. In some alternative embodiments, the intermediate shaft 306 may include more than two layers of braided material, such as three layers.

[0219] like FIG. 9 and 14 As shown, handle 302 may include a steering mechanism configured to adjust the curvature of the distal portion 309 of delivery device 300. In the illustrated embodiment, for example, handle 102 includes an adjustment member, such as the illustrated rotatable knob 360, which is further operatively coupled to the proximal portion of a draw cable. The draw cable extends distally from handle 302 through outer shaft 304 and has a distal portion attached to outer shaft 304 at or near its distal end. Rotating knob 360 may increase or decrease tension in the draw cable, thereby adjusting the curvature of the distal portion 309 of delivery device 300. Further details regarding the steering or deflection mechanism for the delivery device can be found in U.S. Patent No. 9,339,384, which is incorporated herein by reference.

[0220] The handle 302 may further include an adjustment mechanism 361, which includes an adjustment member (such as the illustrated rotatable knob 362) and a shaft 364 extending distally into the housing 366 of the handle 302. The adjustment mechanism 361 is configured to adjust the axial position of the intermediate shaft 306 relative to the outer shaft 304. FIG. 9 and 14 In some embodiments, such as FIG. 14As shown, an inner support 368 is mounted within a housing 366 on the intermediate shaft 306, and an inner shaft 370 (also referred to as a slider or sliding mechanism) is mounted on the inner support 368. The inner shaft 370 has a distal end portion 372 formed with external threads that mate with internal threads extending along an inner surface of the shaft 364. The inner shaft 370 further includes a proximal end portion 374 that mounts and interfaces with a locking mechanism 376 configured to hold (e.g., lock) the position of the intermediate shaft 306 relative to the handle 302. The inner shaft 370 can be coupled to the inner support 368 such that rotation of the shaft 364 causes the inner shaft 370 to move axially within the handle 302. The locking mechanism 376 can include another adjustment member configured to receive a rotatable knob 378 that has an internal thread that engages external threads of the proximal end portion 374 of the inner shaft 370.

[0221] To limit movement of the intermediate shaft 306 for precise positioning of a prosthetic valve mounted on a distal end portion of the delivery apparatus 300, the rotation knob 378, which in turn causes rotation of the inner nut 380. Accordingly, the inner nut 380 translates in a distal direction along the external threads on the proximal end portion 374 of the inner shaft 370. As the nut 380 moves distally, additional components of the locking mechanism 376 are configured to frictionally engage the intermediate shaft 306, thereby holding the intermediate shaft 306 relative to the inner shaft 370. In the locked position, rotation of the knob 362 causes the inner shaft 370 and the intermediate shaft 306 to move axially relative to the outer shaft 304 (in either a proximal or distal direction depending on the direction in which the knob 362 is rotated).

[0222] Rotation of the knob 378 in the opposite direction from the locked position to the unlocked position allows for axial and rotational movement of the intermediate shaft relative to the inner shaft 370 and the proximal end portion of the handle 302. Further details regarding the adjustment mechanism 361 and the locking mechanism 376 of the handle 302 can be found in U.S. Patent No. 9,339,384, which is incorporated by reference herein.

[0223] As described above, the knob 314 of the handle 302 can be configured to rotate the intermediate (e.g., balloon) shaft 306, thereby causing the balloon 318 mounted to the intermediate shaft 306 and the radially compressed prosthetic valve mounted on the balloon 318 to rotate about the valve mounting portion 324. Accordingly, rotation of the knob 314 can cause the prosthetic valve to be rotated about the central longitudinal axis 320 to a desired orientation relative to native anatomy at a target implant site.

[0224] FIGS. 15-22Various views of embodiments of knob 314 are shown, which is configured to rotate intermediate shaft 306 when knob 314 is rotated. In alternative embodiments, a differently configured rotatable knob or other adjustment mechanism may be used instead of knob 314 to rotate intermediate shaft 306 of delivery device 300.

[0225] like FIG. 15 and 16 (and as mentioned above) FIG. 9 and 14 As shown in the perspective view, knob 314 can be mounted on the proximal portion 310 of intermediate shaft 306 on the distal side of adapter 312. In some embodiments, knob 314 can be directly coupled to a portion or the entirety of adapter 312 and / or arranged around a portion or the entirety of adapter 312 (e.g., as shown in the perspective view). FIGS. 102-107 (As shown below). In an alternative embodiment, the knob 314 may be axially spaced from the adapter 312.

[0226] The knob 314 may include an outer housing 382 arranged around one or more internal components of the knob 314 (e.g., housing one or more internal components of the knob 314). FIGS. 15-17 (and 20). In some embodiments, the housing 382 may include one or more gripping elements 383 configured to increase traction or gripping force for a user to rotate or grip the knob 314. In some embodiments, the one or more gripping elements 383 may be protruding elements or features extending outward from the outer surface of the housing 382 and spaced apart from each other around the circumference of the housing 382. In alternative embodiments, the one or more gripping elements 383 may be raised ridges and / or recessed notches in the housing 382.

[0227] In some embodiments, to increase the ease of assembly of the knob 314, the housing 382 may be divided into two or more mating parts. For example, in some embodiments, such as FIG. 15 , 16 As shown in Figure 20, the housing 382 may include a first housing portion 384 and a second housing portion 385 configured to be removably coupled to each other. For example, each of the first housing portion 384 and the second housing portion 385 may include a corresponding mating interface configured to couple the first housing portion 384 and the second housing portion 385 to each other. In this way, the first housing portion 384 and the second housing portion 385 may be coupled to each other about the intermediate shaft 306 and the internal components of the knob 314 to form a knob (e.g., a knob assembly) 314.

[0228] The knob 314 may further include an anchor 386 disposed within the housing 382 and configured to anchor (e.g., couple) the knob 314 to the proximal portion 310 of the intermediate shaft 306. FIGS. 17-19 ). FIG. 19 A cross-sectional view of knob 314 is shown, in which anchor 386 is coupled to intermediate shaft 306 and housing 382 is coupled around anchor 386. FIG. 18 and 19 The sectional view and perspective view of anchor 386 are shown respectively.

[0229] like FIGS. 17-19 As shown, the anchor 386 may include a shaft portion 387 defining an inner cavity 388, configured to receive and couple around an intermediate shaft 306. In some embodiments, the inner cavity 388 has a relatively constant inner diameter.

[0230] In some embodiments, the distal end of the shaft portion 387 may include one or more radial extensions 389 extending around at least a portion of the circumference of the shaft portion 387. FIGS. 17-19 In some embodiments, one or more of the radial extensions 389 may extend around the entire circumference of the shaft portion 387. In some embodiments, one or more radial extensions 389 may be configured as annular barbs spaced axially from each other.

[0231] One or more radial extensions 389 can be configured to engage internally with a sleeve element (which may also be referred to as a strain relief element) 391. FIG. 17 In some embodiments, the sleeve element 391 may be arranged around a portion of the proximal portion 310 of the intermediate shaft 306, and the housing 382 may include a wider first aperture 392 configured to receive the proximal end of the sleeve element 391 therein and / or clamp around the proximal end of the sleeve element 391. FIGS. 15-17 The sleeve element 391 can be configured to eliminate strain between the knob and the proximal portion of the second shaft. In some embodiments, the sleeve element 391 may include a flexible and / or elastic material, such as an elastic polymer material (e.g., rubber).

[0232] The housing 382 may further include a narrower second aperture (e.g., channel) 393, which is configured to receive the distal portion of the adapter 312. FIG. 17 and 20 ).

[0233] like FIGS. 17-19As shown, the anchor 386 may include one or more extensions (e.g., shafts or pins) 394 configured to mate with (e.g., extend into and / or couple to) a corresponding channel or hole 395 disposed in the housing 382. FIG. 17 and 20 The extension portions 394 may be spaced apart from each other and extend radially outward from the shaft portion 387 of the anchor 386.

[0234] In some embodiments, such as FIGS. 17-19 As shown, anchor 386 may include two extensions 394 extending from each of two opposite sides of anchor 386. However, in alternative embodiments, anchor 386 may include more or fewer than four extensions 394. The number of holes 395 may be the same as the number of extensions 394.

[0235] In some embodiments, the mating portions of the hole 395 and the corresponding extension 394 may be hexagonal. However, in alternative embodiments, other shapes are also possible, such as rectangles, squares, etc.

[0236] In some embodiments, anchor 386 may be configured for bonding (e.g., UV bonding) to the outer surface of intermediate shaft 306. For example, in some embodiments, the shaft portion 387 of anchor 386 may include one or more centering ribs 396 circumferentially spaced around and extending along the inner lumen 388. FIG. 18 and 19 In some embodiments, the shaft portion 387 may include an observation hole 397 (e.g., configured as a window) that allows a user to observe the alignment and / or engagement between the anchor 386 and the intermediate shaft 306. FIG. 18 and 19 For example, such as FIG. 17 As shown, the orifice 397 may extend between the outer and inner surfaces of the shaft portion 387 and is disposed in the central portion of the shaft portion 387. In some embodiments, the proximal portion of the shaft portion 387 of the anchor 386 may include a countersunk hole 398. FIG. 17 and 18 The countersunk hole 398 enables enhanced UV bonding between the anchor 386 and the intermediate shaft 306.

[0237] Knob 314 may also include alignment lugs or extensions 399. FIGS. 21-22 The adapter 312 is configured to contact a non-transparent mark (e.g., on the distal portion 309 of the delivery device 300) disposed on the delivery device 300. FIG. 28 The mark 500 shown FIGS. 32A-32B The mark 600 or shown FIG. 33The markings 650 shown are aligned. In some embodiments, as FIG. 21 and 22 The alignment lugs 399 can extend radially outward from the anchor 386, as shown. In some embodiments, the alignment lugs 399 can extend radially outward from the shaft portion 387 of the anchor 386 in a direction that is disposed in a direction perpendicular to a direction in which the extension portion 394 extends radially outward from the shaft portion 387 of the anchor 386. As described further below, during assembly, the alignment lugs 399 can align with the second port 340 of the adapter 312 such that they extend outward in relatively the same direction relative to the central longitudinal axis 320 (e.g., both point outward from the same side of the intermediate shaft 306, as FIG. 21 and 22 shown).

[0238] In some embodiments, the knob 314 can be assembled to the proximal portion 310 of the intermediate (e.g., balloon) shaft 306 in the following manner. However, it should be noted that the assembly method described below is exemplary, and alternative assembly methods are also possible.

[0239] In some embodiments, during assembly, the sleeve element 391 can be installed on and / or around the proximal portion 310 of the intermediate shaft 306. The anchor 386 can then be positioned on and around the intermediate shaft 306 adjacent to the sleeve element 391. In some embodiments, when the intermediate shaft 306 is resting on a relatively flat surface (e.g., a table), the delivery device 300 can be positioned such that the radiopaque markings on the distal portion 309 point upward (e.g., away from the table, which will appear in the plane of the page in FIG. 21 , and the anchor 386 can be positioned such that the alignment lugs 399 point away from the user (e.g., the person assembling the device), as FIG. 21 shown. For example, in FIG. 21 , the flat surface of the table can be in the plane of the page. After this portion of the alignment is complete, the anchor 386 can be bonded (e.g., via UV bonding) to the intermediate shaft 306, and the sleeve element 391 can then be positioned over the radial extensions 389 of the anchor 386.

[0240] In some embodiments, the assembly method can further include bonding the adapter 312 to the intermediate shaft 306 such that the second port 340 points in the same direction as the alignment lugs 399, and / or the second port 340 and the alignment lugs 399 are circumferentially aligned relative to the circumference of the intermediate shaft 306 FIG. 21 and 22). In this way, during the implant procedure, the user can know the initial (e.g., starting) position of the radiopaque marker on the distal portion 309 of the delivery device 300 within the patient. This can enable easier and faster rotational positioning of the radiopaque marker and thus the prosthetic valve at the target implant site, as further described below.

[0241] The outer housing 382 can then be positioned around the anchor 386 FIG. 22 ), in some embodiments, this can include positioning the first housing portion 384 and the second housing portion 385 around the anchor 386 and coupling them to one another.

[0242] FIGS. 102-107 Various views of another embodiment of a knob (or handle) 2500 are shown, which is configured to rotate the intermediate shaft 306 of the delivery device 300 when the knob 2500 is rotated. The knob 2500 (which can also be referred to as a handle or a valve rotation control (VRC)) can be functionally similar to the knob 314 (and include the same or similar internal components, as further described below), except that the outer housing 2502 of the knob 2500 is larger and configured to include or enclose an adapter (such as or similar to the adapter 312). Thus, in one particular embodiment, FIG. 9 the delivery device 300 of FIG. 1 includes the knob 2500 instead of the knob 314.

[0243] as shown in perspective and side views of FIG. 102 and 103 respectively, the knob 2500 can be mounted on the proximal portion 310 of the intermediate shaft 306 and enclose or include the adapter 312 (or another similar adapter) therein. For example, as shown in FIGS. 102 to 107 the knob 2500 is arranged around and encloses the adapter 312 therein such that the adapter 312 cannot be grasped or rotated by a user independently of the knob 2500.

[0244] In some embodiments, the outer housing 2502 can include one or more grasping elements 2504 configured to increase traction or grasping for a user to rotate the knob 2500. In some embodiments, as shown in FIGS. 102-107 the one or more grasping elements 2504 can be raised elements or features that extend radially outward from an outer surface of the outer housing 2502 and are spaced apart from one another around a circumference of the outer housing 2502. In alternative embodiments, the one or more grasping elements 2504 can be raised ridges and / or recessed notches in the outer housing 2502.

[0245] In some embodiments, to increase the ease of assembly of the knob 2500, the outer housing 2502 can be split into two or more mating components. For example, in some embodiments, as shown in the exploded view of FIG. 103 and FIG. 104 and 105 the outer housing 2502 can include a first housing portion 2506 and a second housing portion 2508 that are configured to be removably coupled to one another. For example, each of the first outer housing portion 2506 and the second outer housing portion 2508 can include a corresponding mating interface that is configured to couple the first outer housing portion 2506 and the second outer housing portion 2508 to one another. In this way, the first housing portion 2506 and the second housing portion 2508 are capable of being coupled to one another about the intermediate shaft 306 and the internal components of the knob 2500, thereby forming the knob (e.g., knob assembly) 2500.

[0246] Similar to the knob 314 of FIGS. 15-22 the knob 2500 can include an anchor 386 disposed within the outer housing 2502 and configured to anchor (e.g., couple) the knob 2500 to the proximal end portion 310 of the intermediate shaft 306, as shown in the cross-sectional side view of FIG. 106 and 107 For example, the anchor 386 is configured to couple about the intermediate shaft 306 and interface with the sleeve element 391, as described above with reference to FIGS. 15-22 and as shown in FIG. 106 and 107

[0247] As described above with reference to FIGS. 15-22 the outer housing 1502 is configured to couple about and onto the anchor 386 and receive the sleeve element 391 and / or grip about the proximal end of the sleeve element 391. For example, similar to the outer housing 382 of the knob 314, the outer housing 2502 can include a first aperture 2510 (formed by the two halves of the outer housing 2502 when coupled together) that is configured to receive the proximal end of the sleeve element 391 therein and / or grip about the proximal end of the sleeve element 391 FIGS. 104-107 .

[0248] The outer housing 2502 can further include an inner cavity 2512 (at a proximal end thereof) that is configured to receive the adapter 312 FIGS. 104-107 therein. The outer housing 2502 can include a second aperture 2514 (formed by the two halves of the outer housing 2502 when coupled together) that is configured to fit about the first port 338 of the adapter 312 FIGS. 104-107 ​). The proximal end of the first port 338 can extend proximally out and away from the proximal end 2516 of the outer housing 2502 of the knob 2500. In some embodiments, the outer housing 2502 includes a cap 2518 configured to couple around the proximal end 2516 when the first housing portion 2506 and the second housing portion 2508 are arranged together, thereby coupling the first housing portion 2506 and the second housing portion 2508 to each other and forming the closed outer housing 2502 FIG. 102 , 103 , 106 and 107).

[0249] The outer housing 2502 can further include an extension 2556 extending outwardly at an angle from the main body of the outer housing 2502. A portion of the internal cavity 2512 can be formed within the extension 2556 and configured to receive the second port 340 of the adapter 312. In some embodiments, the extension 2556 can include a third aperture 2558 (formed by the two halves of the outer housing 2502 when coupled together) configured to fit around the second portion 340 FIG. 104 and 107 ). The open end of the second port 340 can extend out and away from the third aperture 2558.

[0250] In alternative embodiments, rather than receiving the adapter 312 within the internal cavity 2512, the adapter and the outer housing 2502 can be integrated together (e.g., formed or molded as one piece).

[0251] Similar to the knob 314 as described above with reference to FIGS. 15-22 , the outer housing 2502 of the knob 2500 can include one or more apertures 395 arranged on the interior of the outer housing 2502 and configured to receive and mate with one or more extension portions 394 of the anchor 386 FIGS. 104-106 . In some embodiments, each aperture 395 can be arranged in a radially extending member 2520 extending from an inner surface of the outer housing 2502 FIGS. 104-106 .

[0252] In some embodiments, as described above with reference to FIGS. 21-22 , the anchor 386 can include an alignment tab 399 that can extend radially outwardly from the anchor 386 FIG. 104 and 107 . As described above and as shown in FIG. 104 and 107 , during assembly, the alignment tab 399 can be aligned with the second port 340 of the adapter 312 such that they extend outwardly in relatively the same direction relative to the central longitudinal axis 320 (e.g., both pointing outwardly from the same side of the middle shaft 306, as shown in FIG. 104and 107 as shown).

[0253] In some embodiments, knob 2500 can be assembled onto proximal portion 310 of intermediate (e.g., balloon) shaft 306 in the same or similar manner as knob 314, as described above with reference to FIGS. 3A-3C. FIGS. 15-22

[0254] For example, in some embodiments, during assembly, sleeve element 391 can be mounted on and / or around proximal portion 310 of intermediate shaft 306. Anchor 386 can then be positioned on and around intermediate shaft 306 adjacent to sleeve element 391. In some embodiments, when intermediate shaft 306 is resting on a relatively flat surface (e.g., a table), delivery device 300 can be positioned such that the radiopaque markers on distal portion 309 are pointing upward (e.g., away from the table), and anchor 386 can be positioned such that alignment lugs 399 are pointing away from the user. After this portion of the alignment is complete, anchor 386 can be bonded (e.g., via UV bonding) to intermediate shaft 306, and sleeve element 391 can then be positioned over radial extensions 389 of anchor 386.

[0255] In some embodiments, the assembly method can further include bonding adapter 312 to intermediate shaft 306 such that second port 340 is pointing in the same direction as alignment lugs 399, and / or second port 340 and alignment lugs 399 are circumferentially aligned relative to the circumference of intermediate shaft 306. In this manner, during an implantation procedure, a user can know the initial (e.g., starting) position of the radiopaque markers on distal portion 309 of delivery device 300 within a patient. This can enable easier and faster rotational positioning of the radiopaque markers, and thus the prosthetic valve, at a target implantation site, as further described below.

[0256] Outer housing 2502 can then be positioned around anchor 386 and adapter 312 (as shown). FIGS. 104-107 In some embodiments, this can include positioning first housing portion 2506 and second housing portion 2508 around anchor 386 and coupling them to anchor 386, thereby coupling the distal ends of first housing portion 2506 and second housing portion 2508 to each other. Cap 2518 can then be coupled to proximal end 2516 of knob 2500, thereby coupling the proximal ends of first housing portion 2506 and second housing portion 2508 to each other. These connections can allow first outer housing portion 2506 and second outer housing portion 2508 to be held together without the use of adhesives or additional fasteners.

[0257] ​In some embodiments, the outer housing 2502 can include one or more indicators 2522 (e.g., markings) that indicate to a user how the knob 2500 should be rotated in order to align a radiopaque marker (e.g., marker 500 or any other marker described herein) on a distal end portion of the delivery device with a guidewire that is being advanced through a center of the delivery device (e.g., under fluoroscopy during an implantation procedure, as described herein). For example, in some embodiments, each indicator 2522 can include a printed marking that includes a line representing the guidewire, a visual representation of the radiopaque marker on either side of the line (e.g., a“C” marker as shown), and an arrow on either side of the line that indicates to the user how to rotate the knob 2500 if the radiopaque marker appears on a selected imaging view during the implantation procedure not to be aligned with the guidewire, as described further herein (e.g., during the method at 1308, as described below with reference to FIG. 13). FIG. 57

[0258] For example, if the radiopaque marker on the distal end portion of the delivery device (e.g., marker 600 or another marker described herein) appears on a first side of the guidewire in a fluoroscopy imaging view, the user can rotate the knob 2500 in a first direction (as indicated by the first arrow of the indicator 2522), and if the radiopaque marker appears on an opposite second side of the guidewire in the imaging view, the user can rotate the knob 2500 in an opposite second direction (as indicated by the second arrow of the indicator 2522) in order to position the marker to be aligned with the guidewire during the implantation procedure. In some embodiments, as shown in FIGS. 25A-25B, the first housing portion 2506 and the second housing portion 2508 can each include an indicator 2522, and the two indicators 2522 (one on each housing portion) can be arranged to be spaced apart from each other by 180 degrees around the knob 2500. FIG. 102 103

[0259] In some embodiments, the presence of the knob 314 or the knob 2500 for rotating the middle shaft 306 to achieve a desired rotational positioning of the prosthetic valve at the target implantation site can reduce the likelihood of a user holding and using the adapter 312 to rotate the middle shaft 306 and the prosthetic valve. Such force or torque applied to the adapter 312 can cause damage to the adapter 312. Additionally, by fully enclosing or surrounding the adapter 312 within the knob 2500, as shown in FIGS. 25A-25B, the user is prevented from holding the adapter 312 and applying torque to the adapter 312. FIGS. 102-107

[0260] ​​​​In some embodiments, to further deter a user from grasping and rotating the adapter 312 in order to rotationally align the prosthetic valve, a portion of the adapter 312 itself can be rotatable relative to the remainder of the adapter 312 and the intermediate shaft 306.

[0261] For example, FIGS. 23-27 An embodiment of a proximal end portion 400 of a delivery apparatus including an adapter 402 is shown, the adapter 402 including a first port 404 and a second (e.g., inflation) port 406 configured to rotate. In some embodiments, the proximal end portion 400 can be used as FIG. 9 and 14 a proximal end portion of the delivery apparatus 300. Additionally, in some embodiments, the proximal end portion 400 can include similar components as those described above with reference to FIG. 9 and 14 and thus are similarly labeled in FIG. 23 .

[0262] As shown, the proximal end portion 400 can include a handle (e.g., handle portion), such as the handle 302 described above with reference to FIG. 23 and FIG. 9 . However, in alternative embodiments, alternative handle configurations are possible. A rotatable shaft (such as the intermediate (e.g., balloon) shaft 306) can extend distally from the handle 302 (as shown in 14 and FIG. 9 ) and have a proximal end portion 310 (shown in 14 ) that extends proximally from the handle 302 to the adapter 402. Additionally, a rotatable knob 414 can be mounted on the proximal end portion 310 of the intermediate shaft 306 distally of the adapter 402. The knob 414 can be configured to rotate the intermediate shaft 306. In some embodiments, the knob 414 can be the knob 314 described above with reference to FIG. 23 . FIGS. 15-22

[0263] The adapter 402 can further include an adapter body (e.g., body) 408. The adapter body 408 can be coupled (e.g., connected) to the proximal end portion 310 of the intermediate shaft 306 (shown in FIG. 23 and 26 ). For example, the adapter body 408 can include a first internal passageway 410 (shown in FIG. 26 ) configured to receive a proximal end of the intermediate shaft 306 (shown in FIG. 25 ).

[0264] In some embodiments, an additional adapter 442 can be disposed around the intermediate shaft 306 between the knob 414 and the adapter body 408 (shown in FIG. 23 and 26 ). ​

[0265] The first port 404 can extend axially from the adapter body 408. FIGS. 24-26 In some embodiments, the first port 404 may be directly and / or rigidly coupled to the proximal portion 412 of the adapter body 408 defining the second internal channel 416 of the adapter body 408. FIGS. 25-27 For example, in some embodiments, the first port 404 and the proximal portion 412 may be joined together at the joint 444 (e.g., via welding or adhesive). FIG. 25 ).

[0266] In some embodiments, the first port 404 may be configured as a guidewire port suitable for receiving a guidewire. For example, in some embodiments, the guidewire may be inserted into an opening 418 in the first port 404 and extend through an inner shaft 308, which is received within and extends through a second inner channel 416 and a first inner channel 410. For example, as FIG. 26 and 27 As shown, the proximal end of the inner shaft 308 can be arranged and fitted within the distal channel 420 of the first port 404. FIGS. 25-27 The guidewire can then be inserted into the opening 418 and extended through the inner lumen defined by the inner shaft 308.

[0267] The second port 406 can extend radially outward from the adapter body 408 in a direction intersecting the central longitudinal axis 422 of the adapter 402 and the central longitudinal axis (e.g., central longitudinal axis 320) of the delivery device. FIG. 25 In some embodiments, the second port 406 may extend radially outward from the adapter body 408 at an angle between 10 and 90 degrees with respect to the central longitudinal axis 422. In some embodiments, the second port 406 may extend radially outward from the adapter body 408 in a direction perpendicular to the central longitudinal axis 422.

[0268] The second port 406 is rotatably coupled to the adapter body 408. For example, as FIGS. 25-27 As shown, the second port 406 can be rotatably coupled to the proximal portion 412 of the adapter body 408. In some embodiments, the second port 406 may include a base portion 424 arranged around the proximal portion 412 of the adapter body 408.

[0269] Seal 426 can be arranged between the base portion 424 and the proximal portion 412 of the adapter body 408. FIGS. 25-27). In some embodiments, the seal 426 can be a circumferential or annular seal that extends around an outer surface (e.g., around a circumference) of the proximal portion 412 of the adapter body 408. In some embodiments, the seal 426 can include one or more O-ring seals or quadrilateral seals.

[0270] The second port 406 can further include an internal passage (forming an inner lumen) 432 that extends from the opening 428 in the second port 406, through a shaft portion 430 of the second port 406, and through a portion of the base portion 424 that is connected with the shaft portion 430. The shaft portion 430 can extend radially outward from a side of the base portion 424.

[0271] The proximal portion 412 of the adapter body 408 can include an annular groove 434 that defines an annular passage 436 that extends around at least a portion of a circumference of the proximal portion 412 of the adapter body 408 (as best seen in FIG. 25 and 27 ). In some embodiments, the annular passage 436 can fluidly couple the internal passage 432 to an annular space 438 defined between an outer surface of the inner shaft 308 and an inner surface of the proximal portion 412 of the adapter body 408 FIG. 26 and 27 ).

[0272] In some embodiments, one or more holes 440 extending radially inward from the annular groove 434 can fluidly connect the annular space 438 with the internal passage 432 FIG. 25 and 27 ). The annular space 438 can be fluidly coupled to the annular space 336 defined between an outer surface of the inner shaft 308 and an inner surface of the intermediate shaft 306 FIG. 26 . In alternative embodiments, the annular groove 434 can extend through a thickness of the proximal portion 412 of the adapter body 408 so as to fluidly couple the internal passage 432 with the annular space 438.

[0273] In this manner, fluid (e.g., inflation fluid) can flow from the internal passage 432 to the annular space 438, to the annular space 336, and into the inflatable balloon (e.g., as described above with reference to FIGS. 9-14The balloon 318 described is allowed to rotate around the adapter body 408 (e.g., around the central longitudinal axis 422). This prevents the user from attempting to rotate the intermediate shaft 306 by rotating the adapter 402 (e.g., as doing so would cause the second port 406 to rotate around the adapter body 408). Furthermore, rotating the second port 406 avoids applying torque to the adapter body 408 and the first port 404, thereby increasing the durability and lifespan of the adapter 402 and preventing damage to the connection between the adapter 402 and the intermediate shaft 306. This increases the likelihood of more efficient and consistent deployment of the balloon (e.g., balloon 318) by injecting expansion fluid through the second port 406. Moreover, having a rotatable second port 406 allows the user to position the second port 406 in various locations (for injection of expansion fluid) without causing unnecessary movement of the delivery device.

[0274] As referenced above FIGS. 9-27 The described delivery device 300 and / or similarly configured delivery devices may include one or more features that facilitate rotational alignment of a radially compressed prosthetic valve disposed on the distal portion of the delivery device at the target implantation site.

[0275] As mentioned above, it may be desirable to utilize delivery devices (such as...) FIGS. 9-14 The delivery device 300 implants the prosthetic heart valve into the native valve, aligning the suture portion of the prosthetic heart valve with the suture portion of the native valve. In some embodiments, to facilitate desired rotational positioning of the prosthetic heart valve relative to the native valve, radiopaque markers visible under medical imaging may be disposed on or embedded in a portion of a distal portion of the delivery device (such as a polymer body mounted on a distal portion of a shaft), which is located near the valve mounting portion (e.g., valve mounting portion 324) of the delivery device and thus radially compressed prosthetic valve attachment. As further described below, in some embodiments, the radiopaque markers may be configured to be positioned via a balloon (e.g., ...) of the delivery device. FIGS. 9-11 After the balloon (318) expands to radially expand the prosthetic valve, it indicates the location of the selected suture portion of the prosthetic valve.

[0276] FIGS. 28-34B It shows the arrangement in the delivery device (such as FIGS. 9-14 An embodiment of a non-transparent marking on or embedded in a portion of the delivery device 300 shown. Although in FIG. 28 , 29Delivery device 300 is illustrated by way of example in 32A-32B, but in alternative embodiments, radiopaque markers may be disposed on or embedded therein in an alternative delivery device configured to deliver a radially compressed prosthetic valve to a target implantation site. In some embodiments, the portion of the delivery device on which the radiopaque markers are disposed or embedded may be a polymer body mounted on an axis at a distal portion of the delivery device. For example, the polymer body may be a proximal shoulder, a distal shoulder (e.g., FIGS. 9-11 The distal shoulder 326) or the nose cone mounted to the inner shaft of the delivery device (e.g., FIGS. 9-11 One or more of the nose cones 322 in the middle, and / or another polymer body mounted to the inner shaft.

[0277] FIG. 28 It shows the location in the delivery device (e.g., in FIG. 28 and 29 Transparent markings 500 are placed on and / or embedded therein in the polymer body of the distal portion of the delivery device 300 (shown as an example). In some embodiments, such as FIG. 28 As shown, the distal shoulder 326 of the distal portion 309 of the delivery device 300 may include a marker 500 disposed thereon and / or embedded therein.

[0278] like FIG. 28 As shown and referenced above FIGS. 9-11 As explained, the inflatable balloon 318 is disposed on the distal shoulder 326 and the valve mounting portion 324 (e.g., covering the distal shoulder 326 and the valve mounting portion 324). The nasal cone 322 is disposed at the distal end of the delivery device 300 and is disposed near the distal shoulder 326 (and distal to the distal shoulder 326). As described above, the valve mounting portion 324 is configured thereon to receive a radially compressed prosthetic valve around the balloon 318. The distal shoulder 326 can be configured such that when the prosthetic valve is mounted on the balloon 318 in a radially compressed state at the valve mounting portion 324, the distal shoulder 326 prevents movement of the prosthetic valve relative to the balloon 318 in the axial direction (which is arranged along and relative to the central longitudinal axis 320 of the delivery device 300).

[0279] The nasal cone 322 and / or distal shoulder 326 may comprise one or more polymeric materials, and thus may be referred to herein as a polymeric body. In some embodiments, the distal portion 309 of the delivery device 300 may have additional polymeric bodies or components, such as a proximal shoulder disposed on the side of the valve mounting portion 324 opposite to the distal shoulder 326.

[0280] Marker 500 can be configured to be visible under medical imaging. For example, marker 500 may include a radiopaque material configured to be visible under medical imaging, such as fluoroscopy and / or other types of X-ray imaging. In some embodiments, marker 500 may include a radiopaque or other material configured to be visible under MRI, ultrasound, and / or echocardiography. A polymer body (such as distal shoulder 326) disposed thereon and / or embedded therein of marker 500 may be configured such that it is not radiopaque. Thus, marker 500 may be more readily visible under imaging, as referenced below. FIG. 29 Further description.

[0281] Although the mark 500 is FIG. 28 The marker 500 is shown positioned on and / or embedded therein on the distal shoulder 326, but in alternative embodiments, the marker 500 may be arranged on and / or embedded therein on another polymer body or component of the distal portion 309 of the delivery device. For example, in some embodiments, the marker 500 may be positioned on the nasal cone 322 or the proximal shoulder of the delivery device (e.g., FIG. 3 The proximal shoulder 120 shown is on and / or embedded therein.

[0282] Mark 500 can have various shapes or patterns. For example, although mark 500 is... FIG. 28 and 29 The mark 500 is shown as a dot, but in alternative embodiments, the mark 500 can be configured as different shapes or symbols, such as circles, rectangles, stars, squares, triangles, "X", etc. See below for reference. FIGS. 30-34B Another embodiment describing the shape of the marker.

[0283] like FIG. 28 As shown, a mark 500 is disposed on and / or embedded therein in a portion of the distal shoulder 326. In some embodiments, the portion of the distal shoulder 326 on which the mark 500 is disposed and / or embedded may be a portion of the distal shoulder 326 configured to be closer (e.g., adjacent) to the valve mounting portion 324 than the rest of the distal shoulder 326. Thus, when a radially compressed prosthetic valve is disposed on the valve mounting portion 324, the mark 500 may be close to and adjacent to the prosthetic valve arrangement.

[0284] In some embodiments, such as FIG. 28 As shown, the distal shoulder 326 may include a base portion 325 and a flared portion 331. The flared portion 331 may extend radially outward from the base portion 325 toward the valve mounting portion 324. A mark 500 may be disposed on and / or embedded therein in the flared portion 331, such that the mark 500 is oriented radially outward from the outer surface of the inner axis 308. In an alternative embodiment, the mark 500 may be disposed on and / or embedded therein in the base portion 325.

[0285] In some embodiments, such as FIG. 28 As shown, the flared portion 331 may include a plurality of wings 330 (which may also be referred to as extensions) extending radially outward from the base portion 325 at an angle relative to the central longitudinal axis 320. The wings 330 may be spaced apart from each other around the circumference of the flared portion 331. FIG. 28 As shown, in some embodiments, the mark 500 may be positioned on or embedded in one of the wings 330. In some embodiments, the mark 500 may be centered on one of the wings 330 such that it is centered along the central longitudinal axis 320.

[0286] In some embodiments, mark 500 may be a single (e.g., unique) radiopaque mark disposed on the distal shoulder 326. In some embodiments, mark 500 may be a unique (or single) radiopaque mark disposed on the distal portion 309 of the delivery device 300.

[0287] In some embodiments, the distal portion 309 of the delivery device 300 may include additional radiopaque markings (in addition to marking 500).

[0288] Arranging the mark 500 on or within another polymer body of the distal shoulder 326 or the distal portion of the delivery device allows the mark 500 to be more visible under imaging (such as fluorescence fluoroscopy), because the remainder of the distal shoulder 326 may be less or non-transmissive, and therefore less or invisible in fluorescence fluoroscopic images. For example, as FIG. 29 As shown in the exemplary fluorescence fluoroscopic image 550, marker 500 is visible and prominent under fluorescence fluoroscopy because the distal shoulder is not radiopaque (except for marker 500). In contrast, the prosthetic valve frame 552 is radiopaque and visible under imaging. Therefore, radiopaque markers located on and / or within the prosthetic valve itself may be more difficult to see under imaging because the valve frame appears relatively dark in image 550.

[0289] For example FIG. 29 As shown, the guidewire 554, extending through the center of the distal portion 309 of the delivery device (e.g., through the inner lumen of the inner shaft 308), is visible under fluoroscopic examination, and the marker 500 is positioned radially outward from the guidewire 554 (e.g., because the marker 500 is positioned on the flared portion 331 of the distal shoulder 326). This further increases the visibility of the marker 500 under imaging during the implantation procedure. Additionally, as further described below, when the marker 500 is positioned directly behind or in front of the imaging view, the marker 500 may appear to overlap with the guidewire.

[0290] Additionally, disposing the marker 500 on or in the distal shoulder 326 (or another polymer body of the delivery device proximal to the distal end portion) can allow for more accurate alignment with a commissure of the native valve. For example, as described further below, it can be desirable to rotationally align the marker 500 with a target commissure of the native valve prior to passing through a leaflet of the native valve. Thus, when rotating the distal end portion 309 of the delivery device (including the distal shoulder 326 and the prosthetic valve) to align the marker 500 with the target commissure of the native valve, it can be advantageous for the marker 500 to be disposed as far distally on the delivery device as possible so that it is positioned as close as possible to the target commissure of the native valve. As shown, the distal shoulder 326 (and the nose cone 322) is one of the most distal components of the delivery device 300 and is disposed more distal than the radially compressed prosthetic valve (e.g., more distal than the valve mounting portion 324, as seen in FIG. 28 FIG. 28

[0291] Disposing the marker 500 on or in the distal shoulder 326 (or another polymer body of the delivery device positioned axially offset from the prosthetic valve) also allows the marker 500 to be offset in the circumferential direction from the selected commissure of the prosthetic valve. For example, as described further below, since the prosthetic valve rotates upon inflation of the inflatable balloon 318, the marker 500 can be offset in the circumferential direction from the selected commissure of the prosthetic valve to compensate for this rotation. Thus, after deployment of the prosthetic valve, the selected commissure of the prosthetic valve can be aligned with the target commissure of the native valve. If the prosthetic valve itself had an offset marker, this can be confusing after the valve is deployed since the marker would be visible but not actually marking the selected commissure of the prosthetic valve.

[0292] Additionally, providing the marker 500 on or in the distal shoulder 326 (or another portion of the delivery device proximal to the valve mounting portion 324) can avoid having to add additional components to the relatively permanent implant (e.g., the prosthetic valve). Additionally, changes to the marker 500 on the delivery device (e.g., design changes) can be more easily implemented on the delivery device than if the marker 500 were on the valve (e.g., as a result of valve testing as a result of any design modifications to the prosthetic valve).

[0293] ​​During an implantation procedure, a selected imaging view (e.g., a fluoroscopic imaging view) can be used to visualize a distal portion of the delivery device, including the marker 500 and the radially compressed prosthetic valve (e.g., the frame 552), relative to surrounding native anatomy. Based on existing knowledge of the location of a selected commissure of the native valve (where the prosthetic valve is to be implanted) within the selected imaging view, the user can rotationally align the distal portion of the delivery device at the target implantation site such that the marker 500 is aligned with the known location of the selected commissure in the selected imaging view, or such that the marker 500 is disposed in a particular location (e.g., directly behind) within the selected imaging view and deployment of the prosthetic valve in this orientation will result in alignment of the commissure between the prosthetic valve and the native valve.

[0294] For example, in some imaging views, a selected commissure of the native valve can be disposed directly behind the imaging view. Thus, by aligning the marker 500 on the delivery device with the direct behind of the imaging view, the prosthetic valve can be implanted within the native valve with the commissure between the native valve and the prosthetic valve aligned. In FIG. 58 、 61 Exemplary fluoroscopic imaging views obtained during a prosthetic valve implantation procedure and used to guide the delivery device proximate to a native valve are shown in FIGS. 1-3, as further described below.

[0295] To achieve the desired positioning of the marker within the selected imaging view, in some embodiments, the marker can be configured as an asymmetric marker, which is then aligned with a guidewire extending through the delivery device along a central longitudinal axis of the delivery device. For example, the asymmetric marker can reflect asymmetry along an axis parallel to the central longitudinal axis of the delivery device. In this way, under medical imaging such as fluoroscopy, the position of the marker within the imaging view (e.g., the front versus the back of the imaging view) relative to the guidewire can be more easily discerned by a user viewing the imaging view.

[0296] FIGS. 30-34B Example embodiments of such asymmetric markers that allow a user to distinguish between two different positions of the marker within an imaging view are shown. For example, in some embodiments, the asymmetric marker is configured such that a user viewing the imaging view can distinguish between the marker being positioned in the front or the back of the fluoroscopic imaging view. FIGS. 30-34B The illustrated marker can be positioned on the delivery device as described above with reference to FIG. 28 and 29 For example, in some embodiments, the illustrated marker can replace the distal shoulder 326 of the distal portion 309 of the delivery device or replace the marker 500 on the polymer body FIGS. 30-34B The illustrated marker can be positioned on the delivery device as described above with reference to FIG. 28 and 29 .

[0297] In some embodiments, asymmetric markings may be letters of an asymmetric alphabet reflected along an axis parallel to the central longitudinal axis of the delivery device (e.g., such as...). FIGS. 30-34B (as shown), numbers, symbols, shapes, etc. For example, an asymmetrical marker may have a first orientation and a second orientation, in which it can be read "correctly" or forward (e.g., not backward), and the second orientation rotates about 180 degrees from the first orientation about an axis, which causes the marker to appear backward to the reader (e.g., the user).

[0298] FIG. 30 It is shown to be shaped into the letter "C" and can be combined with FIG. 28 A first exemplary embodiment of an asymmetrical mark 600 is similarly configured to the mark 500 (e.g., non-transmissive). The C-shaped asymmetrical mark 600 is asymmetrically reflective across a longitudinal axis 602, and when positioned on a delivery device (e.g., delivery device 300), as referenced above. FIG. 28 As described, the C-shaped asymmetric mark 600 is parallel to the central longitudinal axis of the delivery device. For example, in FIG. 30 In the image, the C-shaped asymmetric mark 600 is in a first orientation, which is its forward-readable orientation (e.g., presented to the reader in its correct, rather than backward, orientation). If the C-shaped asymmetric mark 600 is rotated approximately 180 degrees about its longitudinal axis 602, the C-shaped asymmetric mark 600 will be in a second orientation, and the "C" will appear backward (e.g., flipped). Both orientations of the C-shaped asymmetric mark 600 can be seen in a medical imaging view (e.g., using fluoroscopy), as further explained herein. The two orientations of the C-shaped asymmetric mark (and other asymmetric marks described herein) can be mirror images of each other.

[0299] FIG. 31A and 31B Guide wire 606 extending through the distal portion of the delivery device (e.g., distal portion 309 of delivery device 300) and a portion disposed in the distal portion of the delivery device (e.g., distal shoulder 326, as shown) are illustrated respectively. FIG. 28 Exemplary fluorescent perspective images 610 and 612 of the C-shaped asymmetric mark 600 on or embedded therein (as shown). FIG. 31A As shown in the first fluorescence imaging 610, the C-shaped asymmetric mark 600 is aligned (e.g., overlapped) with the guidewire 606, and the "C" is readable in its first (forward) orientation. In some embodiments, FIG. 31A The position of the marker 600 shown indicates that the marker 600 is positioned behind the guidewire 606 within the first fluorescence fluoroscopic imaging view 610, and therefore directly behind the imaging view. In an alternative embodiment, FIG. 31AThe position of the illustrated marker can indicate that the marker is disposed in front of the guidewire 606, and thus directly in front of the imaging view.

[0300] In contrast, when the delivery device is rotated approximately 180 degrees from FIG. 31A the illustrated orientation, the C-shaped asymmetric marker 600 correspondingly rotates and appears in its second (rearward) orientation, with the "C" facing rearward, as FIG. 31B illustrated. In some embodiments, FIG. 31B The position of the illustrated marker 600 can indicate that the marker 600 is disposed in front of the guidewire 606 within the imaging view, and thus directly in front of the imaging view. In alternative embodiments, FIG. 31B The position of the illustrated marker 600 can indicate that the marker is disposed behind the guidewire 606, and thus directly behind the imaging view.

[0301] In this manner, by observing the orientation of the reflective asymmetric marker (e.g., marker 600) relative to the guidewire 606 within a selected imaging view, the position of the marker 600 at the implantation site (e.g., proximate to the target native valve) can be more easily and quickly determined. Further details regarding rotationally aligning the marker relative to the guidewire so that the prosthetic valve is implanted in alignment with the commissures of the native valve are explained below with reference to FIGS. 57-60

[0302] FIG. 32A and 32B respectively illustrate side and perspective views of an example positioning of the asymmetric marker 600 (shaped as the letter "C") on and / or embedded within the distal shoulder 326 of the distal end portion 309 of the delivery apparatus 300. As FIG. 32A and 32B illustrated, the marker 600 can be positioned on the distal shoulder 326 (e.g., on the wing 330 in some embodiments) so that when the delivery apparatus is disposed within the vasculature of a patient, and similarly to the view of the image 550 in FIG. 29 the longitudinal imaging view is used to visualize the delivery apparatus. When the marker 600 is directly in front of the imaging view, the C-shape of the marker 600 will be read in a rearward orientation, and when the marker 600 is positioned directly behind the imaging view, the marker 600 will be read in a forward orientation.

[0303] In alternative embodiments, the marker 600 can be oriented differently on the distal shoulder than FIG. 32A and 32B illustrated, so that the marker 600 is rotated 180 degrees, and instead is read in a forward orientation when the marker 600 is directly in front of the imaging view.

[0304] FIGS. 33-34B illustrates a marker 600' shaped as the letter "E" and which can be oriented differently than the marker 600.​FIG. 28 A second exemplary embodiment of the asymmetric marker 650 is similarly configured to the marker 500 (e.g., non-transmissive). FIG. 33 The E-shaped asymmetric mark 650 is shown separately, while FIG. 34A and 34B Fluorescent images of E-shaped asymmetric markers 650 in two different orientations relative to guidewire 606 are shown on the delivery device.

[0305] Apart from its overall shape (e.g., E-shaped rather than C-shaped), the E-shaped asymmetric mark 650 can be compared with the reference above. FIGS. 30-32B The described mark 600 is similarly configured and functions. For example, an E-shaped asymmetric mark 650 can reflect asymmetry across a longitudinal axis 652, which, when positioned on a delivery device, is parallel to the central longitudinal axis of the delivery device.

[0306] Similar to mark 600, E-shaped asymmetric mark 650 has a first orientation, which is its forward (or "correct") readable orientation (e.g., FIG. 33 and 34A (As shown in the first image 654). The E-shaped asymmetric mark 650 also has a second orientation, which is rotated approximately 180 degrees from the first orientation about its longitudinal axis 652. In the second orientation, the "E" appears rearward (as shown in the first image 654). FIG. 34B (As shown in the second image 656). These two orientations of the E-shaped asymmetric mark 650 can be seen using medical imaging (e.g., fluorescence fluoroscopy), as... FIG. 34A and 34B As shown and further explained in this article.

[0307] In some embodiments, the E-shaped asymmetric mark 650 can be replaced FIG. 32A and 32B Mark 600 on the delivery device shown.

[0308] In other embodiments, the asymmetric marking may be shaped as described above to be another letter (other than “C” or “E”, such as “P” or “F”), number, symbol, shape, etc., that is reflectively asymmetrical, and has two distinguishable orientations when rotated about 180 degrees around its reflectively asymmetrical axis.

[0309] In some embodiments, asymmetric markings (e.g., marking 600 or marking 650) disposed on or embedded in the distal portion of the delivery device (such as the distal shoulder 326) may comprise a radiopaque material. In some embodiments, the radiopaque material comprises a metal.

[0310] In some embodiments, the asymmetric markers described herein can include tantalum. In some embodiments, the asymmetric markers described herein can include another type of radiopaque material or combination of materials, such as one or more of iodine, barium, barium sulfate, tantalum, bismuth, or gold.

[0311] In some embodiments, the asymmetric markers described herein can comprise a platinum-iridium alloy. In some embodiments, the alloy ratio of the platinum-iridium alloy is 90: 10. In some embodiments, the alloy ratio of the platinum-iridium alloy is in the range of 75:25 to 95:5. In some embodiments, the alloy ratio of the platinum-iridium alloy is in the range of 85: 15 to 95:5.

[0312] In some embodiments, instead of or in addition to being positioned on the distal end portion of the delivery apparatus, the radiopaque markers can be positioned on the prosthetic valve, such as on or near the commissure of the prosthetic valve, as shown in FIGS. 97-101E. Thus, the location of the selected commissure of the radially compressed prosthetic valve can be identified by medical imaging during the valve implantation procedure and rotationally aligned with the native anatomy at the target implant site. FIGS. 35A-35P

[0313] In embodiments where the radiopaque markers are disposed on the distal end portion of the delivery apparatus (as described above) and on the prosthetic valve (on or near the commissure, as described below), the first radiopaque markers on the delivery apparatus can be visualized during the valve implantation procedure to rotationally align the first markers with the native anatomy and deploy the prosthetic valve such that its commissure is aligned with the commissure of the native valve. The second radiopaque markers on the prosthetic valve can then be visualized after implantation (e.g., during a future intervention to locate the prosthetic valve commissure and / or confirm the position of the prosthetic valve commissure relative to the native valve commissure). In some embodiments, the second radiopaque markers at the commissure of the prosthetic valve can be more easily visualized after radial expansion of the prosthetic valve (after implantation).

[0314] In FIG. 1 and 35B are shown exemplary embodiments of radiopaque markers 700 attached to a commissure 702 of a prosthetic valve 704, which can be similar to any of the prosthetic valves described herein, such as the prosthetic valve 10 of FIG. 2A or the prosthetic valve 50 of FIG. 35A and 2B . FIG. 35B is shown the prosthetic valve 704 in a radially compressed configuration (e.g., state) (such as when it is arranged around and crimped onto a delivery apparatus), and FIG. 2A is shown the prosthetic valve 704 in a radially expanded configuration (e.g., state).

[0315] ​As introduced above with reference to FIG. 35A and 2B and as shown in FIG. 35E and 35B , in some embodiments, the commissure 702 of the prosthetic valve 704 can include attachment members 706 arranged across cells (e.g., commissure cells) 708 of the frame 710 of the prosthetic valve 704. In some embodiments, the attachment members can include fabric, flexible polymer, or the like arranged on the cells 708. As explained herein, the cells 708 can be formed by struts 712 of the frame 710. The attachment members 706 can be arranged across the cells 708 and secured to the struts 712 of the frame 710 forming the cells 708 via fasteners 714 (e.g., sutures). Additionally, adjacent portions of the two leaflets 716 of the prosthetic valve 704 can be connected to the attachment members 706 to form the commissure 702.

[0316] In some embodiments, the commissure tabs of the two adjacent leaflets 716 are coupled to the attachment members 706 on an inner surface 726 of the attachment members 706 (as described below) and the marker 700 is disposed on an outer surface 724 of the attachment members 706. FIG. 35A

[0317] In some embodiments, as shown in FIG. 35A and 35B , the marker 700 can be arranged on a central region of the commissure cells 708. For example, in some embodiments, the marker 700 can be sewn to the central region of the attachment members 706 via one or more fasteners (e.g., sutures) 722.

[0318] In some embodiments, the marker 700 can be shaped and positioned such that it fits within the cells 708 when the frame 710 is in a radially compressed configuration, as shown in FIGS. 28-34B .

[0319] In some embodiments, the commissure cells 708 can be arranged at an outflow end 718 of the prosthetic valve 704.

[0320] In some embodiments, the marker 700 includes tantalum or another radiopaque material described herein or known in the art that is formed or laser cut into a shape that reflects asymmetry across the axis, similar to that described above with reference to FIG. 35B .

[0321] In some embodiments, the prosthetic valve 704 includes a skirt 720 arranged around the frame 710 of the prosthetic valve 704 at an inflow end (e.g., an end arranged opposite the outflow end 718) of the prosthetic valve 704. FIG. 35A FIGS. 35C-35H and​​35B As shown, the commissure unit 708 including the marker 700 can be spaced apart from the skirt 720 in the axial direction when the commissure unit 708 is arranged at the outflow end 718 of the prosthetic valve 704.

[0322] FIGS. 35C-35H Another exemplary embodiment of attaching a radiopaque marker 750 to the commissure within the unit 708 of the prosthetic valve is shown. FIG. 35A The prosthetic valve shown can be the same prosthetic valve as the prosthetic valve 704 shown in FIGS. 35C-35H and 35B The prosthetic valve 704 shown can be the same prosthetic valve as the prosthetic valve 704 shown in FIGS. 35C-35H and is therefore FIG. 35C correspondingly labeled. However, in there are two attachment members arranged across the unit 708 and attached to the struts 712 forming the unit 708. The commissure tab 754 of the leaflet 716 and the marker 750 can be sewn to different attachment members of the two attachment members.

[0323] For example, the attachment member 706 to which the commissure tab 754 of the leaflet 716 is attached can be a first attachment member 706 FIGS. 35C-35G , 35D and 35H), and the marker 750 can be attached to a second attachment member 752 FIG. 35A .

[0324] The marker 750 can be similar to the marker 700 and other radiopaque markers described herein. For example, the marker 750 can be configured (e.g., shaped and sized) such that the marker 750 fits within the unit 708 when the frame 710 is in the radially compressed configuration (e.g., as shown in FIG. 35I .

[0325] An exemplary embodiment of the marker 750 is shown in FIG. 35A . The marker 750 can be oval-shaped with a first (upper) hole 726 and a second (lower) hole 728 configured to receive a fastener (e.g., a suture) for securing the marker 750 to the attachment member, as further described below. In some embodiments, the marker can include more or less than two holes (e.g., one, three, four, etc.) for receiving a fastener. In some embodiments, the marker 750 can have a different shape configured to fit within the unit 708 when the frame 710 is radially compressed, such as one of the other marker shapes and embodiments described herein (e.g., with reference to FIG. 35A , 35B and 35J-35P).

[0326] In some embodiments, the marker 750 can be shaped as a letter of the alphabet (e.g., as shown in FIG. 35A and 35B .

[0327] In some embodiments, the marker 750 can be reflectionally asymmetric across an axis parallel to the central longitudinal axis 760 of the frame 710 (e.g., as shown in FIG. 35C and 35B .

[0328] As shown in FIG. 35H , the first attachment member 706 can be secured to the strut 712 forming the unit 708 via a fastener (e.g., a suture) 714. The commissure tabs 754 of two adjacent leaflets 716 can be coupled to the first attachment member 706 at an inner surface 756 of the first attachment member 706, as shown in FIG. 35C (the commissure tabs 754 are identified by the regions 755 in FIG. 35C ). For example, the commissure tabs 754 can be sutured directly to the inner surface 756 of the first attachment member 706, or via one or more intervening layers of fabric between the commissure tabs 754 and the first attachment member 706 to the inner surface 756 of the first attachment member 706.

[0329] As also shown in FIG. 35I , the marker 750 is secured to the second attachment member 752 via one or more fasteners 758 (e.g., sutures) that can extend through a first hole 726 and a second hole 728 in the marker 750 FIG. 35C . In some embodiments, the marker 750 can be sutured to a central region of the second attachment member 752 with the fasteners 758.

[0330] In other embodiments, the marker 750 can have another number of holes or a different shape configured to receive the fasteners 758 for securing the marker 750 to the second attachment member 752. For example, in some embodiments, the marker 750 can be ring-shaped (e.g., shaped like the letter “O”).

[0331] FIG. 35G The marker 750 is shown attached to the second attachment member 752 but before the second attachment member 752 is assembled to the frame 710. FIG. 35C The marker 750 and the second attachment member 752 are shown after the second attachment member 752 is positioned at the commissure unit 708, such that the marker is disposed between the first attachment member 706 and the second attachment member 752 and sutured to the struts of the frame with one or more sutures 762. In this way, the marker 750 is positioned between the first attachment member 706 and the second attachment member 752, as shown in FIG. 35G and 35G .

[0332] In some embodiments, as shown in FIG. 35GAs shown, the second attachment member 752 can be arranged relative to the frame 710 such that the exposed metal material of the marker 750 faces the outer surface 724 of the frame 710 and the first attachment member 706.

[0333] Thus, when the second attachment member 752 is arranged across the cell 708 and attached to the strut 712 forming the cell 708, as FIGS. 35D-35F shown, the marker 750 can be sandwiched (e.g., disposed) between the second attachment member 752 and the first attachment member 706.

[0334] In some embodiments, the second attachment member 752 can comprise a similar or identical fabric material as the first attachment member 706.

[0335] In some embodiments, the second attachment member 752 can be secured to the strut 712 via additional fasteners (e.g., sutures).

[0336] In other embodiments, as FIG. 35D shown, the second attachment member 752 and the first attachment member 706 can be secured to the strut 712 simultaneously and with the same fasteners (e.g., sutures 762). For example, in some embodiments, after the commissure tabs 754 of two adjacent leaflets 716 are secured to the first attachment member, the top portion of the first attachment member 706 can be initially secured to the upper strut 712 of the cell 708 with a first suture 762a FIG. 35D ). The second attachment member 752 with the marker 750 secured thereto can then be aligned with the first attachment member 706 FIGS. 35D-35G and 35E ). The first suture 762a can then be passed through both the first attachment member 706 and the second attachment member 752 and around the strut 712 on the first side of the cell 708 FIGS. 35E-35G , thereby forming a single load-bearing suture from the top to the bottom of the cell 708. Similarly, a second suture 762b can be passed through both the first attachment member 706 and the second attachment member 752 and around the strut 712 on the second side of the cell 708 FIG. 35C , thereby forming another single load-bearing suture from the top to the bottom of the cell 708.

[0337] In this way, the second attachment member 752 is arranged outside of the first attachment member 706 relative to the outer surface of the frame 710 and the central longitudinal axis 760 of the frame 710 FIGS. 35J-35P). Thus, contact of the metal between the marker 750 and the frame 710 on the frame and / or any abrasive contact between the marker 750 and the outside (e.g., outer surface) of the frame 710 can be avoided. Additionally, contact between the marker 750 and the leaflets (which are secured to the inner first attachment members 706) is also avoided by securing the marker 750 to the outer second attachment members 752.

[0338] In some embodiments, the marker 750 can be secured to the strut 712 with a suture pattern that avoids the tissue of the leaflets 716. In some embodiments, the additional material provided by the second attachment members 752 can also protect the knots and sutures used to secure the commissure tabs 754 to the first attachment members 706, making the commissures more robust and durable.

[0339] As described above, due to its positioning on the frame 710 and its radiopaque nature, the marker 750 can provide identification (e.g., visibility) of the commissures during the implantation procedure, enabling the desired commissure alignment as described herein. Additionally, such a radiopaque marker 750 can also provide identification of the location of the commissures of the prosthetic valve after implantation and during any future intervention procedures.

[0340] FIG. 35L Additional embodiments of radiopaque markers are shown that are configured to be attached to the commissures within the cell 708 of the prosthetic valve, to additional attachment members that are then attached to the cell 708, or to additional skirt or fabric material directly and / or axially below the location of the commissures (e.g., as shown in FIGS. 35J-35P For example, in some embodiments, any of the markers shown FIGS. 35A-35B may replace the markers 700 FIG. 35C ) on the prosthetic valve 704 or the markers 750 FIGS. 35A-35P -H) on the second attachment members 752. Additionally, FIG. 35L Any of the markers shown FIGS. 35J-35P may be attached to the additional skirt or fabric material directly and / or axially below the location of the commissures (e.g., as shown in

[0341] FIGS. 35J-35P The exemplary markers shown have different shapes or configurations. In some embodiments, the shape of the marker and / or the mounting location on the valve can be selected based on the geometry and spatial limitations of the valve (e.g., the size of the cells of the frame). In certain embodiments, when the frame 710 of the prosthetic valve is in its radially compressed and radially expanded configurations, FIG. 35J One or more of the markers shown

[0342] FIG. 35JExemplary embodiments of radio-opaque markers 766 secured to attachment members 706 arranged across cells 708 of frame 710 with one or more fasteners (e.g., sutures) 768 are shown. As shown, markers 766 are arcuate, with their longest dimension arranged in a circumferential direction (e.g., across the width of cells 708). However, in alternative embodiments, markers 766 can be oriented differently within cells 708, such as where their longest dimension extends in an axial direction (e.g., as shown in FIG. 35J, discussed below). FIG. 35L As shown, markers 766 are arcuate, with their longest dimension arranged in a circumferential direction (e.g., across the width of cells 708). However, in alternative embodiments, markers 766 can be oriented differently within cells 708, such as where their longest dimension extends in an axial direction (e.g., as shown in FIG. 35J, discussed below). FIG. 35K As shown, markers 766 are arcuate, with their longest dimension arranged in a circumferential direction (e.g., across the width of cells 708). However, in alternative embodiments, markers 766 can be oriented differently within cells 708, such as where their longest dimension extends in an axial direction (e.g., as shown in FIG. 35J, discussed below).

[0343] FIG. 35L Exemplary embodiments of radio-opaque markers 766 secured to attachment members 706 arranged across cells 708 of frame 710 with one or more fasteners (e.g., sutures) 768 are shown. As shown, markers 766 are arcuate, with their longest dimension arranged in a circumferential direction (e.g., across the width of cells 708). However, in alternative embodiments, markers 766 can be oriented differently within cells 708, such as where their longest dimension extends in an axial direction (e.g., as shown in FIG. 35J, discussed below).

[0344] FIG. 35L Exemplary embodiments of radio-opaque markers 766 secured to attachment members 706 arranged across cells 708 of frame 710 with one or more fasteners (e.g., sutures) 768 are shown. As shown, markers 766 are arcuate, with their longest dimension arranged in a circumferential direction (e.g., across the width of cells 708). However, in alternative embodiments, markers 766 can be oriented differently within cells 708, such as where their longest dimension extends in an axial direction (e.g., as shown in FIG. 35J, discussed below). FIGS. 35J-35L As shown, markers 766 are arcuate, with their longest dimension arranged in a circumferential direction (e.g., across the width of cells 708). However, in alternative embodiments, markers 766 can be oriented differently within cells 708, such as where their longest dimension extends in an axial direction (e.g., as shown in FIG. 35J, discussed below).

[0345] Markers 766, 770, 774, and 776( FIGS. 35J-35LEach of the markers shown in FIGS. 7A-7E can include one or more mounting holes 784 configured to receive one or more fasteners (e.g., fasteners 768, 772, 775, or 780) for securing the marker to the attachment member 706 or one or more skirts 778. As shown in FIG. 7A, the mounting holes 784 can be circular. However, in alternative embodiments, the mounting holes 784 can have different shapes (e.g., oval, rectangular, triangular, etc.) and / or sizes (e.g., a diameter or width that is smaller than a width of the marker). FIGS. 35M-35P

[0346] FIGS. 35M-35P Additional example embodiments of radiopaque markers that are reflectionally asymmetric along an axis parallel to a central longitudinal axis of a frame 710 of a prosthetic valve 704 are shown. Thus, FIG. 35M The markers shown can provide an indication of a location of the commissure 702 relative to a guidewire under fluoroscopy imaging (as explained herein).

[0347] For example, FIG. 35N Example embodiments of radiopaque markers 786 secured to an attachment member 706 arranged across a cell 708 of a frame 710 with one or more fasteners (e.g., sutures) 787 are shown. The markers 786 include an elongated cutout or hole 789 disposed on a first side of the marker 786 (relative to a central longitudinal axis 790 of the marker 786). Thus, on an opposite second side of the marker 786 (across the axis 790), the marker 786 includes a solid material portion 791. One or more fasteners 780 extend through the hole 789, around the marker 786, and into the attachment member 706. Because the solid material portion 791 and the hole 789 are disposed on opposite sides of the marker 786 relative to the axis 790, the marker 786 is reflectionally asymmetric across the axis 790.

[0348] FIG. 35M Another example embodiment of a radiopaque marker 792 secured to an attachment member 706 arranged across a cell 708 of a frame 710 with one or more fasteners (e.g., sutures) 787 and configured similarly to the marker 786 FIG. 35H For example, the marker 792 also includes a hole 789 disposed from the solid material portion 791 across the axis 790 of the marker 792. However, the hole 789 and the solid material portion 791 of the marker 792 are shaped differently (e.g., further elongated) than the marker 786.

[0349] In certain embodiments, the markers described above can be secured to the attachment member 706, secured in a region of a leaflet, or secured to tissue of a leaflet (e.g., the commissure tab 754 of the leaflet 716, as FIG. 35O ​(As shown). For example, the lower connecting lug of the leaflet 716 of the connecting portion 702 is shown in the figure as the central area of ​​the heavier cross-shading on the attachment member 706. In some embodiments, the marking may be configured to be attached to the attachment member 706 outside this tissue area, thereby avoiding the placement of additional fasteners or sutures into the tissue of the connecting lug of the leaflet.

[0350] FIG. 35O and 35P An exemplary embodiment of a translucent mark is shown, which is attached to another attachment member (e.g., which may be fabric), and the other attachment member is then attached to the attachment member 706 outside the underlying tissue region 799. For example, FIG. 35P An exemplary embodiment of a radiopaque marker 794 is shown, which is secured to an additional attachment member 793 by one or more fasteners (e.g., sutures) 797, which may extend through a central hole (or incision area) 795 in the marker 794. The additional attachment member 793 may be directly secured to the attachment member 706 from the outside of a tissue region 799 by one or more fasteners (e.g., sutures) 796. Therefore, the marker 794 can be secured to the attachment member 706 by the additional attachment member 793 without the marker 794 itself being directly secured to the attachment member 706.

[0351] Similarly, FIG. 35O Another exemplary embodiment is shown of a radiopaque marker 794 secured to an additional attachment member 798 by one or more fasteners (e.g., sutures) 797 that can extend through a central hole (or cut area) 795 in the marker 794. The additional attachment member 798 can then be directly secured to the attachment member 706 by one or more fasteners 796. ​ and 35P As shown, the additional attachment member 798 has a rhomboid shape, while the additional attachment member 793 has a rectangular shape. Alternative shapes for the additional attachment members are possible (e.g., circular, square, etc.).

[0352] exist Figures 97-101E An exemplary method for attaching a radiopaque marker 750 (or any other radiopaque marker described herein) to an attachment member configured to attach to a commissural lug of two adjacent leaflets (thus forming a commissural lug) and to a strut 712 of a unit 708 of a frame 710 of a prosthetic heart valve, such as Figure 35A and 35B As shown.

[0353] Figures 97-99BAn embodiment is shown in which a non-transparent marker 750 is directly attached (e.g., stitched) to an attachment member 730. Figure 97 As shown, the attachment member 730 may include first and second side portions 732a, 732b projecting laterally from the central portion 734 (or central region). The attachment member 730 may further include an upper lug 736 and a lower lug 738 projecting from the upper and lower edges of the central portion 734, respectively. Further details of an attachment member for securing the commissural lugs of adjacent leaflets to a frame unit of a prosthetic valve are described in U.S. Patent Publication No. 2018 / 0028310, which is incorporated herein by reference.

[0354] like Figure 97 As shown, the mark 750 is directly secured to the central portion 734 of the attachment member 730 via one or more sutures 740 (forming one or more knots on the outside of the mark 750). The attachment member 730 can then be folded and secured to the connecting lug of the leaflet, such that the mark 750 is positioned on the radially outward surface 742 of the attachment member 730 (e.g., facing away from the leaflet). Figure 98A and 98B Or on the radially inward-facing surface of the attachment member 730 (e.g., the surface of the connecting lug that is disposed opposite to the radially outward-facing surface 742 and faces the leaflet). Figure 99A and 99B For example, when the mark 750 is fixed to the radially outward-facing surface 742 of the attachment member 730, when fixed to the unit 708, the mark 750 faces outward and away from the interior of the leaflet and frame 710. Figure 98B In contrast, when the mark 750 is fixed to the radially inward-facing surface of the attachment member 730, when fixed to the unit 708, the mark 750 faces inward towards the leaflet. Figure 99B Therefore, as Figure 99A and 99B As shown, mark 750 is located behind attachment member 730.

[0355] Figures 100-101E Another embodiment is shown in which a non-transparent marker 750 is attached (e.g., stitched) to an elongated flap 744 (or extension) of an attachment member 746. As shown Figure 100 As shown, the attachment member 746 is similar to Figure 97 The attachment member 730, except that it includes a longer flap 744 extending from the central portion 734 (instead of the shorter upper lug 736). Figure 101A As shown in -E, the mark 750 can be attached to the wing 744 and the connecting portion (such as) formed together with the attachment member 746 via one or more stitches (or other similar fasteners). Figure 32A and 32BThe sutures (or other similar fasteners) are used to secure the commissure tabs of adjacent leaflets to the attachment member 746 (such as Figure 35H as shown) over the first surface 748 of the flap 744.

[0356] For example, the marker 750 can be placed on the first surface 748 of the flap 744 (which is shown as transparent for purposes of illustration) over one or more apertures in the flap 744. In Figure 100 embodiments, the flap 744 includes two apertures, including a first aperture 701 and a second aperture 703 that can be spaced apart based on the spacing between the first aperture 726 and the second aperture 728 of the marker 750 (e.g., such that the first aperture 701 overlaps the first aperture 726 and the second aperture 703 overlaps the second aperture 728). Figures 100-101E

[0357] The flap 744 can then be folded over the outer surface 705 of the central portion 734 of the attachment member 746 (as shown) over the sutures that extend outward from the outer surface 705 for connecting the commissure tabs of adjacent leaflets to the attachment member 746. Figure 101A Accordingly, the marker 750 is sandwiched between the second (outer) surface 707 of the flap 744 and the outer surface 705 of the central portion 734 of the attachment member 746. Figure 101A

[0358] The first sutures 709 can then be threaded through the second aperture 728 of the marker 750 and through the second aperture 703 in the flap 744 such that they extend outward and away from the second surface 707 of the flap 744. Figure 101B Similarly, the second sutures 711 can be threaded through the first aperture 726 of the marker 750 and through the first aperture 701 in the flap 744 such that they extend outward and away from the second surface 707 of the flap 744. Figure 101B

[0359] In some embodiments, the free ends of the first sutures 709 can be threaded through a looped portion 713 of the first sutures 709 that is arranged on each side of the flap 744 under the flap 744. Figure 101C The first sutures 709 are then tightened against the flap 744, as shown. Figure 101D

[0360] The free (loose) ends of the first sutures 709 can then be tied (or knotted) together to secure the first portion of the marker 750. Figures 101A-101E ​​​​The second (e.g., bottom) portion of the marker 750 can be secured to the attachment member 746 by tying (or knotting) the free (loose) end of each second suture 711 with a corresponding third suture 717 (of a pair of third sutures 717 disposed beneath the flap 744) to secure the second (e.g., bottom) portion of the marker 750 to the attachment member 746. Figure 101E

[0361] In some embodiments, the first suture 709 can be tied in one single knot and one double knot, thereby forming a first knotted portion 715 Figure 101E Each second suture 711 can be tied with a corresponding third suture 717 in one single knot and two double knots, thereby forming a second knotted portion 719 and a third knotted portion 721 on opposite sides of the first hole 701 Figure 101E

[0362] In this manner, the marker 750 can be secured to the flap 744 of the connection member 746 with the same sutures (or similar securing members) used to secure the commissure tabs of adjacent leaflets to the inner surface of the connection member 746. This can simplify the assembly process of the prosthetic heart valve, thereby saving time and assembly costs.

[0363] As described above, the prosthetic valve can be mounted around and radially compressed (e.g., crimped) onto a valve mounting portion (e.g., Figures 9-11 of the delivery device 300 shown in FIGS. 32A-32B) at the distal end portion of the delivery device 300 for delivery of the valve to a target implantation site (e.g., a native valve of a heart). In some embodiments, the inflatable balloon (e.g., Figures 9-11 of the delivery device 300 shown in FIGS. 32A-32B) is pleated and wrapped in a manner that more efficiently folds the balloon material so as to minimize the folded balloon diameter. Thus, the diameter of the prosthetic valve crimped onto the folded balloon in the radially compressed configuration can also be minimized.

[0364] Figure 36 An embodiment of an inflatable balloon 818 folded around a distal end portion 809 of a delivery device 800 is shown. The delivery device 800 can be similar to the delivery device 300 of Figures 9-11 and includes one or more shoulders 802 mounted on an inner shaft 808 that extends distally from a middle (e.g., balloon) shaft 806. The balloon 818 covers a valve mounting portion 824 of the distal end portion 809 of the delivery device 800. The portion of the balloon 818 at the valve mounting portion 824 can include one or more axially extending folds or pleats 830. Such axial pleats 830 can be tightly compressed so as to minimize the profile of the balloon 818 and the prosthetic heart valve crimped thereon. ​​

[0365] In some embodiments, the distal portion 832 of the balloon 818 can include one or more axial folds or pleats 834 when the balloon 818 is in a crimped state ready for insertion into a patient’s vasculature. In some embodiments, the proximal portion 836 of the balloon 818 can include one or more axial folds or pleats 838 when the balloon is in a crimped state in preparation for insertion into a patient’s vasculature. The axial pleats 834, 838 can reduce the overall profile of the distal portion 809 of the delivery apparatus 800 to facilitate passage of the delivery apparatus 800 through an introducer sheath and a patient’s vasculature. Further details of folding a balloon over a distal portion of a delivery apparatus are described in U.S. Provisional Application No. 63 / 051,244, filed July 13, 2020, which is incorporated by reference herein.

[0366] In some embodiments, the balloon 318 of the delivery apparatus 300 as shown in FIGS. 28 and 32A-32B can be folded similarly to the balloon 818 as described above. Figures 9-11 Figure 37 is an example cross-sectional view of the balloon 318 of the delivery apparatus 300, which is wrapped and folded around the inner shaft 308 at the valve mounting portion 324 of the delivery apparatus 300. As shown in Figure 37 the balloon 318 includes a plurality of overlapping pleats or folds 390 when in its crimped configuration and when a prosthetic valve is mounted on the balloon 318 and radially compressed around the balloon 318. The balloon 318 can be folded in such a way that the folded balloon diameter (e.g., in its crimped configuration) is minimized by the pleats 390, which can reduce the diameter of the radially compressed prosthetic valve when crimped thereon.

[0367] As introduced above with reference to Figures 9-11 the distal portion 309 of the delivery apparatus 300 can include a distal tip portion 328 mounted on a distal end of the outer shaft 304. To deliver a prosthetic valve to a target implantation site, the outer shaft 304 and the intermediate shaft (e.g., balloon shaft) 306 can be moved axially relative to each other such that the distal tip portion 328 is disposed at a proximal portion (e.g., proximal portion 333, as shown in Figure 10 ​(As shown above). Therefore, the distal tip portion 328 can serve as a proximal shoulder on the proximal side of the valve mounting portion 324 and prevents the radially compressed prosthetic valve from moving proximally in the axial direction during the advancement of the distal portion of the delivery device to the target implantation site. For example, in some embodiments, the intermediate shaft 306 can be pulled into the outer shaft 304, or the outer shaft 304 can be pushed over the intermediate shaft 306, thereby moving the proximal portion of the balloon 318 into the interior of the distal tip portion 328. In some embodiments, the distal tip portion 328 may include internal and / or external expansion incisions or grooves that provide flexibility to the distal tip portion 328 and allow it to expand radially outward as it moves over the proximal portion of the balloon 318, thereby increasing its ability to act as a balloon shoulder and prevent axial movement of the radially compressed prosthetic valve mounted around the balloon 318 at the valve mounting portion 324.

[0368] In some embodiments, the extended incision of the distal apex portion, arranged along the inner surface of the distal apex portion, may extend axially along the inner surface (relative to the central longitudinal axis of the delivery device). However, these axially extended extended incisions can cause problems when the balloon 318 is rotated to the balloon shaft (e.g., intermediate shaft 306) (because the balloon 318 rotates due to the rotation of the balloon shaft), and when the distal portion of the delivery device is rotated and aligned at the target implantation site as described herein. For example, during balloon or intermediate shaft rotation, folds in the balloon 318 (as referenced above) can cause problems. Figure 36 and 37 The described (likely referring to a device) may be stuck in an axially extending internal expansion cut in the distal apical portion. An example of such an axially extending expansion cut can be found in U.S. Patent No. 9,061,119, which is incorporated herein by reference.

[0369] Therefore, it may be desirable to have a distal tip portion that is configured to extend radially over the proximal portion of the balloon 318 while also allowing the balloon 318 to slide more easily within the distal tip portion without the balloon folds getting stuck when the intermediate shaft of the delivery device is rotated.

[0370] Figures 38-41 An embodiment of the distal portion 309 of the delivery device is shown, wherein the outer shaft 304 includes a distal tip portion 900 mounted on the distal end of the outer shaft 304, and in some configurations, the balloon 318 includes a radial recess 334. Figure 40 and 41 In some embodiments, the distal apex portion 900 may be... Figure 9 and 11 The distal apex portion 328.

[0371] The distal tip portion 900 can be configured as a flex adapter including a flex portion 912 and a coupling portion (also referred to as a straight portion) 914. The flex portion 912 can extend from a distal end of the coupling portion 914 and be configured to flex (e.g., expand radially outward) from the distal end of the coupling portion 914. The coupling portion 914 can be coupled to and mounted around a distal end of the outer shaft 304. Figure 39 ).

[0372] The flex portion 912 can be tapered and have an outer diameter that increases in the distal direction from the distal end of the coupling portion 914 to the distal end of the flex portion 912.

[0373] The flex portion 912 can include a plurality of inner expansion cuts or grooves 902 (also referred to herein as helical inner grooves) and a plurality of outer expansion cuts or grooves 904 (also referred to herein as helical outer grooves) Figure 38 , 39 and 41). As shown in Figure 38 and 39 , the inner expansion grooves 902 are helical and curve around the central longitudinal axis 906 from a proximal end 908 of the flex portion 912 (e.g., where the flex portion 912 extends from the coupling portion 914) to a distal end 910 of the distal tip portion 900. The outer expansion grooves 904 can also be helical and curve around the central longitudinal axis 906 from the proximal end 908 of the flex portion 912 to the distal end 910 of the distal tip portion 900.

[0374] In some embodiments, each groove of the inner expansion grooves 902 can curve around the central longitudinal axis 906 from about 75 to about 110 degrees, from about 80 to about 100 degrees, or from about 85 to about 95 degrees. In some embodiments, each groove of the outer expansion grooves 904 can curve around the central longitudinal axis 906 from about 75 degrees to about 110 degrees, from about 80 degrees to about 100 degrees, or from about 85 degrees to about 95 degrees.

[0375] In some embodiments, the inner expansion grooves 902 are spaced apart from each other and the outer expansion grooves 904 are spaced apart from each other around a circumference of the distal tip portion 900.

[0376] In some embodiments, the inner expansion grooves 902 are offset (e.g., circumferentially offset) from the outer expansion grooves 904 such that a location where one of the outer expansion grooves 904 is recessed into an outer surface of the distal tip portion 900 is disposed between locations where two adjacent grooves of the inner expansion grooves 902 are recessed into an inner surface of the distal tip portion 900. Figure 38 ).

[0377] The internal expansion groove 902 and the external expansion groove 904 are configured such that when the distal apex portion 900 is in the balloon 318 ( Figure 40 When the proximal portion 333 of the valve moves toward the valve mounting portion 324, the flexure portion 912 is allowed to flex radially outward. Figure 41 The distal apical portion 900 is shown on the proximal portion 333 of the balloon 318 during the advancement of a radially compressed prosthetic valve 922 (which may be similar to one of the prosthetic valves described herein) mounted on the valve mounting portion 324 of the delivery device through the patient's vascular system and to the target implantation site.

[0378] The helical shape and orientation of the internal expansion groove 902 can be configured such that during rotation of the intermediate (balloon) axis 306 (e.g., to achieve fusion alignment at the target implantation site, as described herein), the folds of the balloon 318 (e.g., Figure 37 The engagement between the folds or folds (390) shown and the inner expansion groove 902 is reduced, thereby allowing the balloon 318 to slide more easily along the inner surface of the distal tip portion 900 as it rotates within the distal tip portion 900. For example, when the intermediate shaft 306 is rotated, and thus the balloon 318, the helical shape and orientation of the inner expansion groove 902 can prevent the folds of the balloon 318 from sinking into and becoming stuck within the inner expansion groove 902.

[0379] After the prosthetic valve is rolled onto the valve mounting portion 324 and advanced over the proximal portion 333 of the balloon 318 to the distal apical portion 900 (as shown in the image) Figure 41 As shown, fluid disposed within the proximal portion 333 of balloon 318 is displaced and pushed distally within balloon 318. Therefore, the distal portion 332 of balloon 318 can excessively extend radially outward, potentially resulting in an increase in the coiled profile (e.g., diameter) of the prosthetic valve 922. This increased coiled valve profile can lead to increased drag when the delivery device is pushed in and through the loader and sheath of the delivery assembly.

[0380] Therefore, in order to reduce or prevent an increase in the curled profile of the prosthetic valve 922, the distal portion 332 of the balloon 318 may be formed with a radial recess 334 that is recessed inward toward the central longitudinal axis 320 of the delivery device. Figure 40 and 41 In some embodiments, the radial recess 334 may be recessed inward relative to the outermost radial surface of the distal shoulder 326. For example, as... Figure 40As shown, the distal portion 332 of the balloon 318 may extend over the wider flare portion 331 of the distal shoulder 326 (e.g., which may be formed by the wing portion 330), then be radially recessed toward the base portion 325 of the distal shoulder 326, and then extend radially outward back to the proximal end of the nasal cone 322, thereby forming a radial recess. Figure 40 The image shows the balloon 318, which includes a radial recess 334 in the distal portion 332, before the prosthetic valve is rolled onto the valve mounting portion 324 and advanced over the distal tip portion 900 of the balloon 318 on the proximal portion 333.

[0381] After the prosthetic valve is rolled onto the valve mounting portion 324 and advanced over the proximal portion 333 of the balloon 318 to the distal apical portion 900 (as shown in the image), Figure 41 As shown), fluid disposed within the proximal portion 333 of balloon 318 is displaced distally within balloon 318 and pushed to the distal portion 332 of balloon 318. The radially concave distal portion 332 of balloon 318 can then radially expand (e.g., partially inflate) as it receives the displaced fluid. Figure 41 (solid line) and Figure 26 The extended state 924 is shown as (dashed line). The radial recess 334 can be configured (e.g., sized) such that the distal portion 332 can receive displaced fluid without radially extending a portion of the balloon 318 within the valve mounting portion 324, thereby preventing an increase in the curled profile of the prosthetic valve 922.

[0382] Before balloon 318 is inflated to deploy the prosthetic valve 922 at the target implantation site, the distal apical portion 900 can be axially moved away from the prosthetic valve 922 and away from balloon 318 (by pulling the outer axis 304 proximally relative to the intermediate axis 306 or by pushing the intermediate axis 306 distally relative to the outer axis 304). The prosthetic valve 922 can then be deployed and radially expanded by inflating balloon 918.

[0383] When balloon 318 inflates (e.g., when the distal portion of the delivery device and the prosthetic valve have reached the target implantation site (such as the native valve)), balloon 318 unwinds (e.g., opens) to its expanded state, thereby radially expanding the prosthetic valve to its radially expanded state. When balloon 318 expands and its folds or creases 390 open (…),… Figure 37) the prosthetic valve radially expands and rotates a predetermined (e.g., known) amount. For example, the deployment of the crimps 390 of the balloon during balloon inflation causes the prosthetic valve to rotate. Thus, the position of the radially expanded prosthetic valve is rotated a predetermined amount (e.g., 10°, 20°, 30°, etc.) from its position on the delivery device prior to inflating the balloon 318. In some embodiments, during manufacturing of the delivery device, the balloon can be wound and / or folded in a consistent and / or standardized manner such that a consistent amount of rotation of the prosthetic valve occurs during valve deployment (e.g., for multiple delivery devices manufactured in the same manner).

[0384] Thus, it can be desirable to mount (e.g., crimp) the prosthetic valve in its radially compressed state onto the valve mounting portion of the delivery device such that a selected commissure of the prosthetic valve is offset from a marker (e.g., Figure 28 the marker 500 of the delivery device 100, Figures 30-32B the marker 600 of the delivery device 200, or Figures 33-34B the marker 650 of the delivery device 300) on the delivery device by a predetermined amount, or at least based on the predetermined amount of rotation. In this manner, the circumferential offset between the marker and the selected commissure of the prosthetic valve can compensate for the rotation of the valve that occurs during balloon inflation and valve deployment. In some embodiments, the predetermined offset amount can be based at least in part on the amount of winding of the balloon and the resulting rotation of the valve that occurs during balloon inflation.

[0385] For example, deploying the prosthetic valve by inflating the balloon after aligning the marker on the delivery device with the guidewire within the selected imaging view (e.g., aligning the asymmetric marker with the guidewire such that the marker is disposed behind the selected imaging view) can cause the prosthetic valve to rotate and implant within the native valve with a commissure of the prosthetic valve aligned with a commissure of the native valve (as described in further detail below). In some embodiments, the marker on the delivery device can be configured to indicate the circumferential position of the selected commissure of the prosthetic valve after valve deployment.

[0386] Figure 42 An example of a prosthetic valve 922 mounted in a radially compressed state on and around the valve mounting portion 324 of the distal end portion 309 of the delivery device 300 is shown, with a selected commissure (indicated by the dashed line in Figure 42 the prosthetic valve 922 can rotate a predetermined amount 932 as it radially expands when the prosthetic valve 922 is deployed via inflation of the balloon such that the selected commissure 930 is ultimately circumferentially aligned with the marker 600. Thus, the selected commissure 930 of the implanted prosthetic valve can be aligned with a selected commissure of the native valve.

[0387] In alternative embodiments, the predetermined offset 932 can be different than a predetermined inflation amount of the prosthetic valve when deployed via inflation of a balloon. For example, as described further below, the predetermined offset amount can be determined based on a desired imaging view selected for viewing the delivery device in the heart during an implant procedure (e.g., based on a known location of a target commissure of the native valve within the selected imaging view). In some embodiments, the predetermined offset amount can be determined based on the selected imaging view and a predetermined amount of rotation of the prosthetic valve when deployed.

[0388] To mount and crimp the prosthetic valve onto the valve mounting portion of the delivery device in a predetermined position and / or orientation (e.g., a circumferential position and / or orientation) relative to the delivery device (e.g., relative to a radiopaque marker on another portion of the distal shoulder or distal end portion of the delivery device), a mounting assembly can be used. The mounting assembly can include a first component configured to interface with an uncrimped (e.g., at least partially radially expanded) prosthetic valve and a second component configured to interface with a portion of the distal end portion of the delivery device (e.g., a portion disposed proximally and / or proximate to the valve mounting portion). The first and second components of the mounting assembly can be further configured to interface with different sides of a crimping device. Thus, the mounting assembly can hold the prosthetic valve in a predetermined orientation and / or a predetermined position relative to the delivery device within the crimper. Then, after the prosthetic valve is crimped onto the valve mounting portion of the delivery device, the prosthetic valve can be disposed in the predetermined position and orientation relative to the delivery device in the radially compressed configuration. For example, the radially compressed prosthetic valve can be disposed on the delivery device such that a selected commissure of the prosthetic valve is circumferentially offset from a marker (or other desired indicia) on the delivery device by a predetermined amount (e.g., as shown in Figure 42

[0389] Figures 43-52 Embodiments of various components that can be used in a mounting assembly configured to crimp a prosthetic valve (such as one of the prosthetic valves described herein) onto a valve mounting portion of a delivery device (e.g., valve mounting portion 324 of delivery device 300) in a predetermined position and orientation are shown. The prosthetic valve can be crimped onto the valve mounting portion of the delivery device in various ways. In some embodiments, a crimping device (such as crimping device 1084 shown in Figure 43 and 44 The crimping device 1084 can be used to crimp the prosthetic valve onto the valve mounting portion of the delivery device, as described further below. The crimping device 1084 can include mating interfaces on opposite sides of the crimping device 1084 that are configured to receive and mate with corresponding mating interfaces on the first and second components of the mounting assembly, as described further below.

[0390] Figure 43 ​a rear perspective view (or a view from a proximal side of the crimping device 1084) of the crimping device 1084 is illustrated, and Figure 44 a front perspective view (or a view from a distal side of the crimping device 1084) of the crimping device 1084 is illustrated. The crimping device 1084 can include a base 1086, an actuator in the form of a handle 1088, and a passageway 1090 for prosthetic valve and delivery apparatus insertion. The crimping device 1084 can include a proximal face 1092 that includes a proximal opening 1094 to the passageway 1090. The proximal opening 1094 can be configured for a delivery apparatus to insert the passageway 1090 therethrough.

[0391] In some embodiments, the proximal face 1092 can include a mating interface having mating structures 1096 in the form of cutouts that can be configured to mate with a positioning device 1072, such as that shown in Figure 49 For example, the mating interface can include one or more mating structures 1096.

[0392] The crimping device 1084 can further include a rotatable body 1098 that is configured to rotate with rotation of the handle 1088. The crimping device 1084 can be operated by a plurality of compression surfaces 1000 that surround the passageway 1090 and are configured to exert a compression force to radially compress a prosthetic valve positioned within the passageway 1090 (e.g., the prosthetic valve 922 shown in Figure 51 and 52 as further described below). The compression surfaces 1000 can surround an axis 1002 of the passageway 1090. The compression surfaces 1000 can be configured such that, as the rotatable body 1098 rotates, the body compresses the compression surfaces 1000 and moves the compression surfaces 1000 toward a center of the passageway 1090, and a diameter of the passageway 1090 decreases. The compression surfaces 1000 can form an iris structure that allows the compression surfaces 1000 to move toward the center of the passageway 1090 and decrease the diameter of the passageway 1090. Due to the radial compression force of the compression surfaces 1000 against the prosthetic valve, the prosthetic valve positioned within the passageway 1090 will thus be compressed within the passageway 1090.

[0393] As shown in Figure 44 The crimping device 1084 can include a distal face 1004 that includes a distal opening 1006 to the passageway 1090. The distal face 1004 can include a mating interface that can include a cutout portion 1008. In some embodiments, the cutout portion 1008 can be configured as a slot, notch, recess, or the like in the distal face 1004. The cutout portion 1008 can be configured (e.g., shaped) to receive an alignment device for a support body of a prosthetic valve (e.g., the alignment member 1024 shown in Figure 45 as further described below).

[0394] The distal opening 1006 can be configured to allow a portion of the device to pass through it during a curling operation performed by the curling device 1084.

[0395] In alternative embodiments, the configuration of the curling device can be changed.

[0396] In order to roll the prosthetic valve onto the valve mounting portion of the delivery device, it may be desirable to maintain the leaflet (e.g., during the rolling of the prosthetic valve onto the delivery device). Figure 2A and 2B The leaflets 60 of the prosthetic heart valve 50 shown are in the open position, thereby reducing the likelihood of leaflet and / or leaflet-to-prosthetic valve frame attachment degradation. Therefore, in some embodiments, a support body configured to support and / or maintain one or more leaflets of the prosthetic valve in the open position can serve as a first component of a mounting assembly configured to hold the prosthetic valve and position it within a retractor.

[0397] exist Figure 45 An exemplary support body 1010 is shown. The support body 1010 can be configured to insert a curling device (such as...) Figure 43 and 44 The illustrated curling device 1084 may have a support portion 1012 configured to be positioned between one or more leaflets of the prosthesis device and a delivery device (e.g., delivery device 300) and to support one or more leaflets in an open position. The support body 1010 may include the support portion 1012 and a coupling portion 1013 configured to be received within and / or coupled to the curling device. The support body 1010 may include a first end 1014 and a second end 1016. The support portion 1012 may include an outwardly facing support surface 1015 configured to receive a prosthesis valve (e.g., abutting against a valve leaflet).

[0398] In some embodiments, such as Figure 45 As shown, the coupling portion 1013 may have a cylindrical shape with a cylindrical outer surface 1018. The coupling portion 1013 may extend from a first end 1014 to a first (e.g., proximal-facing) surface 1020, which may be arranged perpendicular to a central longitudinal axis extending from the first end 1014 to the second end 1016 through the center of the support body 1010. The first surface 1020 may engage the coupling portion 1013 to a support portion 1012 including a support surface 1015. In some embodiments, the first surface 1020 may include an alignment element (such as a recess 1022) which may be configured to receive a coupler (e.g., a coupling element) 1070 of the ring body (also referred to herein as an alignment ring) 1038, such as...Figure 47 and 48 As shown.

[0399] Alignment member 1024 may be arranged on coupling portion 1013 and configured to rotatably align support body 1010 with winding device 1084. Alignment member 1024 may be circumferentially positioned on coupling portion 1013 near first end 1014 at a position that circumferentially aligns support body 1010 within winding device 1084 in a predetermined position and orientation.

[0400] In some embodiments, such as Figure 45 As shown, the alignment member 1024 may include an axially extending protrusion that extends axially outward from a first end 1014 of the support body 1010 toward a second end 1016. In other embodiments, the alignment member may have other configurations, such as being configured to engage with a corresponding mating interface of the curling device 1084 (e.g., Figure 44 The notch portion 1008 shown corresponds to the recess or other alignment features.

[0401] For example, the alignment member 1024 may be configured to be inserted into the cutout portion 1008 on the distal side 1004 of the curling device 1084 to rotatably align the support body 1010 with the curling device 1084. The alignment member 1024 may be further configured to allow the support body 1010 to slide distally out of the cutout portion 1008 during operation of the curling device 1084.

[0402] The support portion 1012 can extend from the first surface 1020 to the second end 1016. The support portion 1012 includes a support surface 1015. The support portion 1012 and therefore the support surface 1015 can have a tapered shape that tapers radially inward in the direction from the first surface 1020 to the second end 1016. For example, the diameter of the support portion 1012 can decrease from the first surface 1020 to the second end 1016. In some embodiments, the support portion 1012 can have a conical shape, such as... Figure 45 As shown. In an alternative embodiment, the support portion 1012 may have another tapered shape as described above, such as a hexagon or a pyramid.

[0403] In some embodiments, the support portion 1012 may have a maximum diameter smaller than the diameter of the cylindrical coupling portion 1013.

[0404] In some embodiments, connector portion 1026 ( Figure 45 The support surface 1015 can be joined to the first surface 1020, and can have an annular shape with a relatively constant diameter.

[0405] The support surface 1015 can be configured for the inner surfaces of the leaflets of the prosthetic valve to contact and rest on the support surface 1015 when the prosthetic valve is positioned around the support portion 1012 (as shown Figure 50 The support surface 1015 can be configured to prevent the leaflets from moving to a closed position when the prosthetic valve is positioned around the support portion 1012 and within the crimping device 1084.

[0406] The tapered shape of the support portion 1012 can allow the support body 1010 to slide distally away from the crimping device 1084 when the crush surface 1000 of the crimping device 1084 is pressed against the support surface 1015, as described above. Thus, the tapered shape of the support portion 1012 can cause the crush force exerted by the crush surface 1000 to move proximally along the tapered shape of the support surface 1015, thereby causing the support body 1010 to move distally and out of the crimping device 1084. The support surface 1015 can maintain the leaflets in the open position when the crush surface 1000 is pressed against the tapered support surface 1015.

[0407] In this manner, the support body 1010 can be configured to slide axially away from the prosthetic valve during and as a result of the crimping device 1084 crimping the prosthetic valve. For example, the support body 1010 can be configured to be inserted into the channel 1090 of the crimping device 1084 and to slide axially away from the channel 1090 as the crimping device 1084 crimps the prosthetic valve 922, and thus can slide in an axially distal direction (as shown Figure 52

[0408] As shown Figure 45 The support body 1010 can include a central aperture 1028 leading to a central channel 1030. The central aperture 1028 and the central channel 1030 can be configured for a delivery apparatus to extend therethrough. The inner surface of the support portion 1012 can define the central channel 1030. The central aperture 1028 can be positioned at the second end 1016, and the central channel 1030 can extend from the second end 1016 to the first end 1014.

[0409] In operation, the prosthetic valve 922 can be slid distally onto the support surface 1015 of the support portion 1012 of the support body 1010 with the frame 940 of the prosthetic valve 922 extending over the support surface 1015 and the inner surfaces of the leaflets 942 of the prosthetic valve arranged against the support surface 1015 (as shown Figure 50 and 51 ).

[0410] ​To align the prosthetic valve 922 about the support portion 1012 at a desired circumferential orientation, and to space the prosthetic valve 922 from the first surface 1020 at a desired distance, a ring body (which can also be referred to as an alignment ring) can be used and positioned on the support body 1010.

[0411] For example, Figure 46 and 47 Perspective views from different sides of a ring body 1038 that can be used with the support body 1010 are illustrated. The ring body 1038 can be configured to couple to the support body 1010 and extend around the support body 1010. The ring body 1038 can include a first surface (which can be a proximally-facing surface) 1040 Figure 46 , a second surface 1042 (which can be a distally-facing surface) Figure 47 opposite the first surface 1040, and an outer (e.g., circumferential) surface 1044 facing radially outward and connecting the first surface 1040 to the second surface 1042. The ring body 1038 can include an inner surface 1046 facing opposite the outer surface 1044 and facing radially inward, the inner surface 1046 defining a central passage (e.g., opening or hole) 1048 of the ring body 1038.

[0412] In some embodiments, an alignment guide can be positioned on the ring body 1038 Figure 46 . The alignment guide can include one or more indicators 1050a-c (which can also be referred to as alignment markers) Figure 46 , 48 and 50) configured to indicate a desired circumferential (e.g., rotational) position of a selected element (e.g., commissure) of the prosthetic valve 922 relative to the ring body 1038. Each indicator 1050a-c can further indicate a desired circumferential position of the selected element of the prosthetic valve 922 relative to the support body 1010 (e.g., when the ring body 1038 is coupled to the support body 1010, as described below with reference to Figure 48 and 50 ).

[0413] Each indicator 1050a-c can include a marking, groove, raised element, or other form of indicator on one or more of the first surface 1040, the second surface 1042, or the outer surface 1044 of the ring body 1038. For example, one or more or each of the indicators 1050a-c can include a change in a surface profile of the ring body 1038, such as a raised portion or a recessed portion (e.g., groove). For example, Figures 46-48The indicators 1050a-c shown in Figure 50 all include recessed portions in the form of grooves on the first surface 1040 and extending to the outer surface 1044. In some embodiments, the indicators 1050a-c may be additionally printed thereon to change the color of the respective indicators 1050a-c, making the indicators more easily visible. In some embodiments, the indicators 1050a-c may be printed only on the ring body 1038 without using variations in the surface profile (e.g., without grooves).

[0414] The indicators 1050a-c may be circumferentially spaced apart from each other on the ring body 1038. In some embodiments, the indicators 1050a-c may be equally spaced apart from each other around the circumference of the ring body 1038. When the ring body 1038 is coupled to the support body 1010 and the prosthetic valve is arranged around the support portion 1012 of the support body 1010 (e.g., as shown in the image), Figure 50 As shown), the circumferential position of each indicator 1050a-c can correspond to and indicate the desired position of one of the suture portions of the prosthetic valve. Therefore, the user can position the annular body 1038 on the support body 1010 and align the suture portions 944a-c of the prosthetic valve 922 with the corresponding indicators 1050a-c. Figure 50 ).

[0415] In some embodiments, the ring body 1038 may include one or more arms (also referred to as body portions) 1052, 1054, each arm extending around and defining the central channel 1048. Figure 46 and 47 Each arm 1052, 1054 may have an arcuate shape forming the ring body 1038. Each arm 1052, 1054 may include half or the other part of the ring body 1038 as needed.

[0416] The first arm 1052 may include a first end portion 1056. Figure 46 ) and the second end portion 1058 ( Figure 47 The first end portion 1056 is positioned at the pivot 1060 that connects the first arm 1052 to the second arm 1054. Figure 46 The second end portion 1058 of the first arm 1052 may include a coupler for coupling to the second arm 1054. The second arm 1054 may include the first end portion 1062 positioned at the pivot 1060. Figure 46 ) and the second end portion 1064 located at the coupler ( Figure 47The coupler (also referred to as the coupling interface) may include a recess in the second end portion 1058 of the first arm 1052 and a protrusion at the second end portion 1064 of the second arm 1054. The protrusion may extend into the recess and may be held in place by an interference fit or another form of coupling. Thus, the corresponding second end portions 1058, 1064 of the first arm 1052 and the second arm 1054 may be configured to couple to each other to hold the ring body 1038 together. If desired, the ring body 1038 may be separated from and removed from the support body 1010 by separating the second end portions 1058, 1064 from each other and pivoting the arms 1052, 1054 about the pivot 1060 to an open position. For example, the ring body 1038 may be opened to be removed from the support body 1010 and may be closed to be held around and coupled to the support body 1010.

[0417] like Figure 46 and 47 As shown, a first lever (e.g., a radial extension) 1066 can extend radially outward from a first arm 1052, and a second lever (e.g., a radial extension) 1068 can extend radially outward from a second arm 1054. Both the first lever 1066 and the second lever 1068 can be configured to be compressed to rotate the first arm 1052 or the second arm 1054 about a pivot 1060, thereby causing the ring body 1038 to move to an open position.

[0418] The ring body 1038 may have an axial width 1071 that defines the distance between the prosthetic valve and the first surface 1020 of the support body 1010. Figure 46 ).

[0419] like Figure 47 As shown, the ring body 1038 may include a coupler 1070 extending axially outward from the second surface 1042. In some embodiments, the coupler 1070 may be a protrusion configured to extend into a recess 1022 of the support body 1010. Figure 45 In an alternative embodiment, the coupler 1070 may be a mating feature of a different shape configured to mate with a corresponding feature on the support body 1010.

[0420] Coupler 1070 can be circumferentially positioned relative to recess 1022 such that the ring body 1038 mates with the support body 1010 in a desired circumferential alignment. In this way, coupler 1070 and recess 1022 can rotatably align the ring body 1038 with the support body 1010, such that the prosthetic valve is circumferentially aligned with the desired orientation relative to the support body 1010 and the curling device.

[0421] In operation, the ring body 1038 can be positioned on and / or around the support body 1010 with the indicators 1050a-c aligned in a desired rotational (e.g., circumferential) orientation relative to the support body 1010 Figure 48 ). For example, Figure 47 The coupler 1070 shown can be received within the recess 1022, thereby circumferentially aligning the ring body 1038 in a desired position relative to the support body 1010. In other embodiments, other alignment devices can be utilized to rotationally align the ring body 1038 in a desired rotational orientation relative to the support body 1010.

[0422] The ring body 1038 can abut the first surface 1020 of the support body 1010. The ring body 1038 can be configured to abut the prosthetic valve 922 when the prosthetic valve 922 is positioned on the support body 1010. Thus, the prosthetic valve 922 can be positioned on the support surface 1015 with the ends of the prosthetic valve 922 abutting the first surface 1040 of the ring body 1038 and defining the position of the prosthetic valve 922 on the support surface 1015. Thus, the ring body 1038 can comprise a spacer configured to define the position of the prosthetic valve 922 on the support body 1010.

[0423] In some embodiments, the ring body 1038 can be oriented in an open configuration with the arms 1052, 1054 open and then can be positioned on and around the support body 1010 with the arms 1052, 1054 closed to secure the ring body 1038 around the support body 1010. For example, the ring body 1038 can be positioned on the connector portion 1026 shown. Figure 45

[0424] The prosthetic valve 922 can then be positioned around the support portion 1012 and the support surface 1015 and against the first surface 1040 of the ring body 1038. The prosthetic valve 922 can be positioned on the support surface 1015 with the commissures 944a-c circumferentially aligned with the indicators 1050a-c and the ends of the prosthetic valve 922 abutting the first surface 1040 Figure 50 ).

[0425] The use of the ring body 1038 can allow the commissures 944a-c of the prosthetic valve 922 to be positioned in a desired circumferential orientation relative to the ring body 1038 and thus relative to the support body 1010 (e.g., relative to the alignment member 1024 of the support body 1010). The alignment member 1024 can then rotationally align the support body 1010 with the crimping device 1084 and thus place the commissures 944a-c of the prosthetic valve 922 within the crimping device 1084 in a desired rotational orientation.

[0426] ​Accordingly, the prosthetic valve 922 can be crimped onto the delivery device in a predetermined circumferential direction relative to the delivery device (e.g., relative to radiopaque markers on the delivery device as described herein).

[0427] The support body 1010 and the ring body 1038 can each be part of an assembly or system (e.g., a mounting assembly) for crimping a prosthetic valve having one or more leaflets onto a delivery device. In some embodiments, the assembly or system can include a positioning device 1072 configured to couple to a portion of the delivery device (e.g., a distal end portion) proximal of the valve mounting portion. For example, Figure 49 An embodiment of such a positioning device 1072 positioned proximal of the valve mounting portion 324 is illustrated. The positioning device 1072 includes a body 1074 including a first portion 1076 and a second portion 1078 joined at a hinge 1080. The body 1074 can include a central passage 1082 in which the intermediate shaft 306 (or another shaft portion, such as the outer shaft 304) of the delivery device can be positioned, with the second portion 1078 rotated about the hinge 1080 to close the central passage 1082 and retain the delivery device (e.g., the intermediate shaft 306) within the central passage 1082.

[0428] The body 1074 can further include a flange portion 1053 including one or more mating surfaces (e.g., interfaces) in the form of a flange 1051 configured to engage mating structures 1096 of a proximal face 1092 of a crimping device 1084. Figure 49 ) as described herein. Figure 43

[0429] The positioning device 1072 can be used to couple to the distal end portion 309 of the delivery device and suspend the distal end portion 309 of the delivery device in position within the passage 1090 of the crimping device 1084 Figure 51 and 52 . Accordingly, the positioning device 1072 can maintain the delivery device spaced apart from the pinch surfaces 1000 of the crimping device 1084, for example as shown in Figure 51 .

[0430] Additionally, the positioning device 1072 can be positioned axially along the delivery device such that the valve mounting portion 324 is maintained within a defined axial position within the passage 1090 of the crimping device 1084. In some embodiments, this feature can further allow the distal shoulder 326 of the delivery device to be positioned outside of and distal of the passage 1090 of the crimping device 1084 such that the distal shoulder 326 is not pinched by the pinch surfaces 1000 during crimping. The delivery device can be further maintained in a defined axial position relative to the prosthetic valve 922 positioned on the support body 1010​Figure 51 ).

[0431] An exemplary method of operation of the systems disclosed herein can include the following steps. Steps can be modified, excluded, or replaced as needed across embodiments.

[0432] Initially, the ring body 1038 can be positioned on the support body 1010 in the configuration shown, for example, in FIG. 10A. The ring body 1038 can be rotationally oriented on the support body 1010 in the defined position, for example, via coupling of the couplers 1070 with the recesses 1022 shown in FIG. 10B. Thus, the prosthetic valve 922 can be positioned on the support surface 1015 with the commissures 944a-c of the prosthetic valve 922 in circumferential alignment with the indicators 1050a-c (as shown in FIG. 10C). The prosthetic valve 922 can be in close proximity to the ring body 1038. Figure 48 Figure 47 Figure 48 Figure 50

[0433] With the prosthetic valve 922 positioned on the support surface 1015 in the desired rotational alignment, the ring body 1038 can then be removed from the support body 1010 prior to crimping the prosthetic valve 922 to the delivery apparatus. For example, the levers 1066, 1068 can be squeezed to rotate the arms 1052, 1054 about the pivot 1060 and open the ring body 1038.

[0434] With the ring body 1038 removed, the support body 1010 can be inserted into the crimping device 1084 with the prosthetic valve 922 positioned around the support portion 1012. For example, FIG. 10E illustrates the prosthetic valve 922 positioned on and around the support portion 1012 and the support body 1010 inserted into the channel of the crimping device 1084. The distal opening 1006 of the crimping device 1084 can be configured for the support body 1010 to insert into the channel 1090. The channel 1090 of the crimping device 1084 can be configured to receive the prosthetic valve 922, the support body 1010, and the distal end portion 309 of the delivery apparatus. Figure 51

[0435] With the support body 1010 inserted into the channel 1090 of the crimping device 1084, the alignment member 1024 can align with (e.g., be received within) the cutout portion 1008 of the crimping device 1084. Thus, the rotational orientation of the support body 1010 and, therefore, the prosthetic valve 922 within the channel 1090 of the crimping device 1084 can be set in the desired position.

[0436] ​​​​​With the support body 1010 and the prosthetic valve 922 inserted into the passage 1090 of the crimping device 1084, the positioning device 1072 (or an alternative positioning device as described further below) can be coupled to the distal end portion 309 of the delivery apparatus and then inserted into the proximal opening 1094 of the crimping device 1084 Figure 51 ). The flange 1051 of the positioning device 1072 can cooperate with the corresponding mating structure 1096.

[0437] Figure 51 A cross-sectional view of the compression surface 1000 around the passage 1090 of the crimping device 1084 and the support body 1010 inserted into the passage 1090 with the prosthetic valve 922 positioned around the support portion 1012 is illustrated.

[0438] As shown in Figure 51 , the support portion 1012 of the support body 1010 extends axially within the passage 1090 toward the proximal opening 1094 of the crimping device 1084. The support surface 1015 can be surrounded by the compression surface 1000. The coupling portion 1013 of the support body 1010 can be disposed outside and distal of the compression surface 1000 and can be held within the distal opening 1006 of the crimping device 1084. The alignment member 1024 can extend proximally into the cutout portion 1008 of the crimping device 1084.

[0439] In Figure 51 , the valve mounting portion 324 of the delivery apparatus is positioned within the passage 1090 of the crimping device 1084. The prosthetic valve 922 is positioned within the passage 1090 and around the valve mounting portion 324 of the delivery apparatus. The support body 1010 is positioned within the passage 1090 and between the prosthetic valve 922 and the delivery apparatus. The support body 1010 supports the leaflets of the prosthetic valve 922 in an open position. The distal end portion 309 of the delivery apparatus extends distally within the internal passage 1090 of the crimping device 1084 and distally within the central passage 1030 of the support body 1010.

[0440] When inserted into the crimping device 1084, the positioning device 1072 can be coupled to the distal end portion 309 of the delivery apparatus proximally of the valve mounting portion 324 and can engage with the mating structure 1096 of the proximal face 1092. The positioning device 1072 can be coupled to the distal end portion 309 of the delivery apparatus at a position such that the valve mounting portion 324 is positioned within the passage 1090 and in a desired position relative to the prosthetic valve 922. For example, as shown in Figure 43 , the prosthetic valve 922 can surround the valve mounting portion 324.

[0441] As described above, due to the prior use of the ring body 1038, the rotational alignment of the prosthetic valve 922 relative to the distal portion 309 of the delivery apparatus can be in a desired predetermined orientation and / or position.

[0442] With the distal portion 309 of the delivery apparatus, the support body 1010, and the prosthetic valve 922 in the desired position within the passageway 1090, the actuator of the crimping device 1084 can be actuated to compress the prosthetic valve 922. For example, the handle 1088 can be rotated to rotate the rotatable body 1098 and move the crimping surface 1000 radially inward against the prosthetic valve 922 Figure 52 and 44 ).

[0443] For example, Figure 52 FIG. 13 illustrates that the crimping surface 1000 has been moved radially inward to apply a compressive force to the prosthetic valve 922. The prosthetic valve 922 is crimped around the valve mounting portion 324 to the delivery apparatus with the crimping surface 1000 of the crimping device 1084. As Figure 52 shown, in its radially compressed state, the length of the prosthetic valve 922 has increased in the axial direction.

[0444] Crimping the prosthetic valve 922 to the delivery apparatus can include applying a force to the support surface 1015 of the support body 1010 with the crimping surface 1000, thereby causing the support body 1010 to slide axially within the passageway 1090 away from the prosthetic valve 922 Figure 52 ).

[0445] For example, as described above, when the crimping surface 1000 moves radially inward, the tapered shape of the support portion 1012 and the support surface 1015 can cause the support body 1010 to slide distally away from the passageway 1090 and away from the crimping surface 1000. The support body 1010 is configured to be releasably coupled to the crimping device 1084 and to slide in a direction axially away from the passageway 1090 as the crimping device 1084 crimps the prosthetic valve 922. In some embodiments, the support body 1010 can be ejected from the distal opening 1006, as Figure 53 shown. The elongated shape of the alignment member 1024 can allow the alignment member 1024 to slide out of the cutout portion 1008.

[0446] In embodiments, the support body 1010 can not be ejected, but can remain coupled to the crimping device 1084 during crimping. For example, the support body 1010 can slide distally while a tether or another form of coupler remains the support body 1010 coupled to the crimping device 1084 such that the support body 1010 does not fall off.

[0447] After the prosthetic valve 922 is crimped to the delivery device, the positioning device 1072 can disengage from the mating structure 1096 and move outwardly from the proximal opening 1094, thereby moving the delivery device outwardly and away from the crimping device 1084. The positioning device 1072 can then be removed from the distal end portion 309 of the delivery device with the prosthetic valve 922 crimped to the delivery device.

[0448] In this manner, the use of a mounting assembly including a support body 1010 can allow the leaflets of the prosthetic valve 922 to remain in an open position during crimping. Such a feature can reduce the likelihood of degradation of the prosthetic valve 922 occurring during crimping. Additionally, the tapered shape of the support surface 1015 can allow the support body 1010 to slide outwardly from the crimping device via the radially inward movement of the extrusion surface 1000, such that the support body 1010 automatically moves outwardly and away from the crimped prosthetic valve 922. The support body 1010 can automatically slide axially outwardly, such that the support surface 1015 is not positioned between the prosthetic valve 922 and the extrusion surface 1000 after crimping. In some embodiments, the system can be configured such that a separate mechanism slides the support body 1010 distally, such that the tapered shape can not be used for the support surface 1015. For example, an arm or a gear or another form of coupler can engage the support body 1010 to move the support body 1010 away from the prosthetic valve 922.

[0449] In some embodiments, the mounting assembly can include a differently configured positioning device configured to mate with one or more mating structures disposed on a side of the crimping device (e.g., the mating structures 1096 of the crimping device 1084). Figure 54 Another embodiment of a positioning device 1100 that can be used in a mounting assembly and coupled to a crimping device is shown, and Figure 53 and 55 side and perspective views, respectively, of a positioning device 1100 coupled to a distal end portion 309 of a delivery device 300 proximally of a valve mounting portion 324 are shown.

[0450] As Figure 53 shown, the positioning device 1100 can include a body 1102 including a first portion 1104 and a second portion 1106 pivotably coupled to one another via a hinge 1108. The body 1102 can include a central passage 1110 Figure 54 configured to receive a middle shaft 306 (or another shaft portion, such as an outer shaft 304) of the delivery device 300 Figure 53 and 55 .

[0451] The second portion 1106 of the body 1102 can include a flange portion 1112 extending radially outwardly therefrom and arranged at a distal end of the positioning device 1100. The flange portion 1112 can include one or more mating elements configured to mate with corresponding shaped mating features in a side surface (e.g., a proximal side surface) of a crimping device. In some embodiments, as shown, the mating elements are configured as circumferentially extending extensions 1114. In some embodiments, the extensions 1114 can be spaced apart from one another around a circumference of the flange portion 1112. Figure 54

[0452] In some embodiments, the flange portion 1112 can include one or more indicator elements 1116 that can indicate a direction in which the extensions 1114 are to be inserted into the crimping device.

[0453] As shown in FIGS. 18A and 18B, the positioning device 1100 is sandwiched around the middle shaft 306 at a location proximally and near the proximal end portion of the balloon 318. Figure 56 55 As shown in FIGS. 18A and 18B, the positioning device 1100 is sandwiched around the middle shaft 306 at a location proximally and near the proximal end portion of the balloon 318.

[0454] Alternative embodiments of mounting assemblies configured to crimp a prosthetic valve onto a delivery device in a predetermined position and / or orientation relative to the delivery device are described in International Patent Application No. PCT / US19 / 28831, which is incorporated by reference herein.

[0455] Figures 43-55 is a flowchart of an exemplary method 1200 for crimping a prosthetic valve into a radially compressed state onto a distal end portion of a delivery device in a predetermined position and in a predetermined orientation relative to the delivery device. In some embodiments, the method 1200 can use one or more components of the mounting assemblies described herein with reference to Figure 1 .

[0456] The method 1200 begins at 1202 by placing (e.g., positioning) a prosthetic valve (e.g., the prosthetic valve 10 of Figures 2A-2B , the prosthetic valve 50 of Figure 41 , or the prosthetic valve 922 of Figure 45 ) onto an implant holder device such that one or more commissures of the prosthetic valve are aligned with one or more corresponding indicators or alignment markers on an alignment ring (or ring body) coupled to the implant holder device. The implant holder device can be configured to receive a prosthetic valve that is at least partially radially expanded and hold the prosthetic valve in a desired circumferential orientation. In some embodiments, the implant holder device can be the support body 1010 of Figures 46-48 and 48 , and the alignment ring can be the alignment ring 1012 of Figure 50 ​​and 50 of the ring body 1038. For example, in some embodiments, the method at 1200 can include rotationally aligning the prosthetic valve on the support portion of the support body such that one or more commissures of the prosthetic valve match and align with corresponding indicators on the ring body (e.g., as shown in Figures 65-68 In alternative embodiments, the alignment ring can be one of the alignment rings shown in Figure 54

[0457] After aligning the commissures of the prosthetic valve on the implant holder device, the method 1200 proceeds to 1204, which includes removing the alignment ring from the implant holder device while the circumferentially aligned prosthetic valve remains attached to the implant holder device.

[0458] At 1206, the method includes attaching the positioning device to the delivery apparatus. In some embodiments, attaching the positioning device can include coupling a portion of the positioning device around a shaft of the delivery apparatus proximal to a valve mounting portion of the delivery apparatus and a proximal portion of an inflatable balloon of the delivery apparatus. In some embodiments, the positioning device can be coupled to and surround a middle (e.g., balloon) shaft of the delivery apparatus (e.g., the middle shaft 306 as shown in Figure 49 The positioning device can be one of the positioning devices described herein (e.g., the positioning device 1072 of Figures 53-55 or the positioning device 1100 of Figure 43 or another positioning device configured to couple to the delivery apparatus and the crimping device and hold the delivery apparatus in a desired circumferential orientation relative to the crimping device. For example, at 1206, the method can include coupling the positioning device to the delivery apparatus such that the radiopaque markers on the delivery apparatus are held in the desired circumferential orientation within the crimping device when the positioning device is coupled with the crimping device.

[0459] The method 1200 proceeds to 1208 and includes placing (e.g., arranging or coupling) the distal end portion of the delivery apparatus and the positioning device into a first side (e.g., proximal side) of the crimping device (e.g., the crimping device 1084 of Figure 28 and 44 or another crimping device). For example, the flange portion of the positioning device including one or more mating elements can be coupled to the first side of the crimping device such that the one or more mating elements mate with one or more corresponding mating elements in the first side of the crimping device. Thus, the distal end portion of the delivery apparatus coupled with the positioning device can be arranged within the crimping device with the valve mounting portion arranged within a portion of the crimping device configured to press against and crimp the prosthetic valve. In this manner, the positioning device and the valve mounting portion of the delivery apparatus can be received within the crimping device in a predetermined circumferential orientation and position.

[0460] ​At 1210, the method includes placing the implant holder device into the second side (e.g., distal side) of the crimping device. For example, at 1210, the method can include inserting the implant holder device into the second side of the crimping device such that the alignment member of the implant holder device is inserted into and / or mates with the corresponding mating structure or element of the crimping device. In this way, the implant holder device and the prosthetic valve arranged on the implant holder device can be received within the crimping device in a predetermined orientation. For example, when both the implant holder device coupled to the prosthetic valve and the positioning device coupled to the delivery apparatus are coupled to the crimping device, the selected commissure of the prosthetic valve can be offset from the radiopaque marker (e.g., one of the markers such as Figure 42 、 18 A-18B or 42) on the distal end portion of the delivery apparatus in a circumferential direction relative to the central longitudinal axis of the delivery apparatus by a predetermined amount.

[0461] At 1212, the method includes crimping the prosthetic valve into a radially compressed state onto the valve mounting portion of the delivery apparatus using the crimping device. In some embodiments, crimping the prosthetic valve at 1212 can include crimping the prosthetic valve into its radially compressed state around the inflatable balloon at the valve mounting portion. Additionally, in some embodiments, crimping the prosthetic valve at 1212 can include crimping the prosthetic valve into a radially compressed state on the valve mounting portion of the delivery apparatus while maintaining the predetermined offset amount between the radiopaque marker and the selected commissure of the prosthetic valve (e.g., as shown in Figure 51 FIG. 18B, as described above). As further described below, the predetermined offset amount can be determined (e.g., preselected) based on a desired or selected imaging view for imaging the distal end portion of the delivery apparatus during the implantation procedure and rotationally aligning the prosthetic valve with the native anatomy (e.g., to achieve commissure alignment). During the crimping at 1212, in some embodiments, the implant holder device can automatically detach from the prosthetic valve and / or the crimping device (e.g., as described above with reference to Figure 57 and 52 .

[0462] At 1214, the method includes removing the distal end portion of the delivery apparatus on which the prosthetic valve is crimped from the crimping device. At 1214, the method can further include removing (e.g., detaching) the positioning device from the delivery apparatus. In this way, the positioning device can be removably coupled to the delivery apparatus and the implant holder device can be removably coupled to the prosthetic valve, as described above. After removal from the crimping device, the delivery apparatus can then be ready for insertion into a blood vessel of a patient and navigation to the heart of the patient.

[0463] Figures 9-11is a flowchart of an example method 1300 for implanting a prosthetic valve at a native valve of a patient's heart with one or more selected commissures of the prosthetic valve aligned with one or more corresponding commissures of the native valve (e.g., in a circumferential direction). In some embodiments, the method 1300 can be performed with a delivery device configured to deploy a radially compressed prosthetic valve mounted on a distal end portion of the delivery device via inflation of a balloon of the delivery device. In Figures 58-68 An example delivery device 300 is shown in FIGS. 1-42. The delivery device can include one or more of the components described herein to help rotationally align the delivery device at an implant site (e.g., a native valve), thereby enabling commissure alignment as described above. In alternative embodiments, the method 1300 can be performed with a delivery device configured to deploy a radially compressed valve by axially moving a sheath tube or capsule covering the radially compressed valve (and thus moving the capsule rather than inflating a balloon to deploy the prosthetic valve) relative to a shaft of the delivery device.

[0464] The method 1300 begins at 1302 and includes receiving a prosthetic heart valve mounted in a radially compressed configuration on a distal end portion of a delivery device with an inflatable balloon of the delivery device about the prosthetic heart valve and in a predetermined position relative to the delivery device and in a predetermined orientation, such that a selected commissure of the prosthetic heart valve is offset from a radiopaque marker on the distal end portion of the delivery device by a predetermined amount in a circumferential direction relative to a central longitudinal axis of the delivery device. In some embodiments, the predetermined amount is determined based on a selected imaging view, as described below with reference to Figures 30-34B which is further described below.

[0465] In some embodiments, as described above with reference to Figures 32A-32B the marker can be asymmetrically reflective along an axis parallel to the central longitudinal axis. In some embodiments, the marker can be positioned on a polymer body of the delivery device, such as a proximal shoulder, a distal shoulder, or a nose cone. In some embodiments, the marker is disposed on and / or embedded in a flared portion of a distal shoulder of the delivery device, distal of a valve mounting portion of the delivery device (e.g., as shown in Figure 56 and 42).

[0466] In some embodiments, at 1302, the method can include crimping the prosthetic heart valve onto the distal end portion of the delivery device using a mounting assembly, as described above with reference to the method of Figures 15-22 .

[0467] At 1304, the method includes advancing the distal portion of the delivery apparatus toward a native valve of the patient's heart. In some embodiments, at 1304, the method can additionally include first inserting the distal portion of the delivery apparatus into the patient's vasculature with the inflation port of the adapter of the delivery apparatus facing the user (e.g., the user performing the implant procedure) so as to orient the radiopaque marker entering the patient so that it faces the table on which the patient is positioned (e.g., due to the arrangement of the adapter 312 and rotatable knob 314 relative to the marker, as described above with reference to FIGS. 31A-31B and 34A-34B). Figure 29

[0468] After advancing the distal portion of the delivery apparatus to a position proximate to the native valve (e.g., within the patient's heart), the method continues to 1306 and includes visualizing the position of the radiopaque marker on the distal portion of the delivery apparatus relative to the guidewire extending through the shaft of the delivery apparatus under fluoroscopy and for a selected imaging view. For example, as described above with reference to Figure 29 , 31A -31B and 34A-34B, the radiopaque marker can be visualized along with the guidewire and additional components (e.g., the valve frame of a prosthetic valve mounted on the delivery apparatus) using medical imaging such as fluoroscopy. The position of the radiopaque marker relative to the guidewire can be seen in the selected imaging view (e.g., the marker can appear radially offset from the guidewire when not directly in front of or behind the guidewire in the imaging view, as shown in the example of FIG. 35A). Thus, because fluoroscopy does not provide a perspective to naturally distinguish what is in front of and behind in the selected imaging view, such a perspective can be provided by visualizing the position of the asymmetric marker relative to the guidewire, as further described below. Figures 61-64

[0469] As further described below with reference to Figure 58 , a user can select from a plurality of possible imaging views for imaging the position of the heart and the distal portion of the delivery apparatus relative to the native valve. For each imaging view, the location within the selected imaging view of a target commissure of the native valve to be aligned with a selected commissure of the prosthetic heart valve (after implantation) can be known. In Figure 58 an example fluoroscopic image 1400 of a native (e.g., aortic) valve 1402 viewed with a more standard tricuspid imaging view is shown. As Figure 59 ​​As shown, the native aortic valve 1402 includes three leaflets: the non-coronary cusp 1404, the right coronary cusp 1406, and the left coronary cusp 1408. In the three-cusp view, the non-coronary cusp 1404 and the left coronary cusp 1408 are disposed opposite one another in this view, and are both overlapped by a portion of the right coronary cusp 1406. Thus, the commissure between the non-coronary cusp 1404 and the left coronary cusp 1408 is known to be behind the image 1400.

[0470] At 1308, the method includes rotating the shaft of the delivery apparatus, which rotates the prosthetic heart valve and the marker, until the marker is centered along the guidewire and in a predetermined orientation in the selected imaging view, before crossing the native valve. The method at 1308 can be performed when the heart is being imaged and the selected imaging view is being observed.

[0471] In some embodiments, the predetermined orientation in the selected imaging view is the direct back (e.g., away from the observer) of the imaging view. In alternative embodiments, the predetermined orientation in the selected imaging view can be the direct front (e.g., toward the observer) of the imaging view. Thus, in some embodiments, the radio-opaque marker can be configured as an asymmetric marker that has a first orientation when it is in front of the guidewire (e.g., in the direct front of the imaging view) and a different second orientation when it is behind the guidewire (e.g., in the direct back of the imaging view). In this way, the asymmetric marker can help the user distinguish between the marker being positioned between the front and the back of the selected imaging view (whether the marker is behind or in front of the guidewire as compared to a symmetric marker that looks the same in the imaging view to the observer).

[0472] For example, in some embodiments, as Figure 59 shown, the asymmetric marker 600 can be configured as a letter of the alphabet that appears forward (e.g., a forward-facing “C”, as Figure 31A shown) when the marker is centered along the guidewire 606 and disposed in the direct back of the imaging view (e.g., behind the guidewire, as Figure 31B shown), and appears backward (e.g., a backward-facing “C”, as Figure 60 shown) when the marker is centered along the guidewire and disposed in the direct front of the imaging view. Thus, at 1308, the method can include rotating the shaft of the delivery apparatus, which rotates the prosthetic heart valve and the marker, until the marker is centered along the guidewire and appears in its forward-facing orientation within the selected imaging view, thereby positioning the marker in the direct back of the imaging view.

[0473] In alternative embodiments, the asymmetric marker can appear forward when the marker is centered along the guidewire and disposed directly in front of the imaging view (e.g., in front of the guidewire), and the asymmetric marker can appear backward when the marker is centered along the guidewire and disposed directly behind the imaging view. Accordingly, in these embodiments, at 1308, the method can include rotating the shaft of the delivery apparatus, which rotates the prosthetic heart valve and the marker, until the marker appears centered along the guidewire and in its backward orientation within the selected imaging view, thereby positioning the marker directly behind the imaging view.

[0474] In other embodiments, at 1308, the method can include rotating the shaft of the delivery apparatus, which rotates the prosthetic heart valve and the marker, until the marker appears centered along the guidewire and in a predetermined orientation (backward or forward) within the selected imaging view, thereby positioning the marker directly in front of the imaging view. In this manner, the predetermined offset between the selected commissure of the prosthetic heart valve and the marker on the delivery apparatus can be determined based on the selected imaging view and the target orientation of the marker in the selected imaging view (directly in front or directly behind).

[0475] By rotating the distal portion of the delivery apparatus prior to passing through the native valve, blood flow through the native valve, which can be stenotic, can not be obstructed by the delivery apparatus. Additionally, in some embodiments, if the crimped prosthetic valve is to be rotated within the native valve (e.g., across the native valve), which can have calcified leaflets, emboli can result from knocking off calcium chips from the leaflets, which can lead to stroke or other medical complications. Accordingly, by rotating the distal portion of the delivery apparatus and the radially compressed prosthetic valve outside of the native valve (e.g., in the ascending aorta), emboli and other complications can be reduced or avoided. Additionally, the user can spend more time rotating, as the delivery apparatus is not in a position that can obstruct blood flow through the native valve.

[0476] After achieving the desired rotational positioning of the radiopaque marker relative to the guidewire at 1308, the method proceeds to 1310, which includes advancing the distal portion of the delivery apparatus, including the radially compressed prosthetic heart valve, through and into the native valve, and inflating the balloon to radially expand the prosthetic heart valve and implant the prosthetic heart valve into the native valve such that the selected commissure of the prosthetic heart valve is aligned with the target commissure of the native valve.

[0477] In some embodiments, during inflation, the prosthetic heart valve rotates an amount equal to the predetermined offset between the marker and the selected commissure when the prosthetic heart valve is radially compressed around the balloon as the prosthetic heart valve radially expands. For example, as shown in FIG. 13B, the prosthetic heart valve 1302 rotates an amount equal to the predetermined offset 1304 between the marker 1306 and the selected commissure 1308 when the prosthetic heart valve 1302 is radially expanded. Figure 60as shown in the exemplary schematic view of FIG. 15, when the target commissure 1450 of the native valve 1452 is to be directly behind the selected imaging view for rotational positioning at the implantation site and the marker 600 is aligned directly behind the selected imaging view, the prosthetic heart valve 922 can rotate an amount equal to the predetermined offset between the marker and the selected commissure 930 of the prosthetic valve 922 (as indicated by arrow 1454 in FIG. 15) when the prosthetic valve 922 is radially compressed around the balloon, thereby implanting the prosthetic valve 922 with the selected commissure 930 circumferentially aligned with the target commissure 1450 of the native valve 1452. Figures 61-68

[0478] In alternative embodiments, during expansion, the prosthetic heart valve rotates more or less than the offset between the marker and the selected commissure when the prosthetic heart valve is radially expanded around the balloon. However, this offset can be predetermined based on prior knowledge of the selected imaging view and the location of the target commissure of the native valve within the selected imaging view. In this way, during the method 1300, the marker on the delivery device can still be aligned with the guidewire (e.g., directly behind the selected imaging view), but the predetermined offset between the marker and the selected commissure of the radially compressed prosthetic valve can be adjusted for different imaging views, such that upon balloon expansion, the prosthetic valve rotates and is implanted with the commissure aligned with the commissure of the native valve.

[0479] Examples of this rotational alignment and adjustment of the circumferential offset between the marker on the delivery device and the selected commissure of the radially compressed prosthetic heart valve for different imaging views are described below with reference to Figure 61

[0480] In Figure 62 a first embodiment of a more standard tricuspid imaging view 1500 of a native valve 1510 is shown in FIG. 15, which, as described above, can be used to visualize the delivery device in the patient’s heart and rotationally align the prosthetic valve during the implantation procedure. In the tricuspid imaging view 1500, the non-coronary cusp 1502 and the left coronary cusp 1504 of the native valve (e.g., an aortic valve) 1510 are disposed opposite one another in the view and are both overlapped by different portions of the right coronary cusp 1506, with all three cusps aligned along a transverse axis 1508. Thus, as shown in the cross-sectional view of the native valve 1510 in FIG. 15, for the tricuspid imaging view 1500, a selected commissure 1512 of the native valve 1510 disposed between the non-coronary cusp 1502 and the left coronary cusp 1504 is disposed directly behind the tricuspid imaging view 1500. Figure 62 Figure 63 ​​​An imaging view showing the right coronary artery apex valve 1506 located directly behind 1516 is also shown.

[0481] In comparison, Figure 64 A schematic diagram of a second embodiment of a different right / left apical valve overlap view 1550 of the native valve 1510 is shown. As described above, this right / left apical valve overlap view 1550 can be used to visualize the delivery device in the patient's heart and rotatably align the prosthetic valve during the implantation procedure. In the right / left apical valve overlap view 1550, the left coronary apical valve 1504 and the right coronary apical valve 1506 overlap each other, and the non-coronary apical valve 1502 is offset from the left coronary apical valve 1504 and the right coronary apical valve 1506. Figure 61 As shown in the cross-sectional view of the native valve 1510, for the right / left cusp valve overlap view 1550, the selected commissure 1512 is circumferentially offset from the directly behind the imaging view 1514.

[0482] It should be noted that, in alternative embodiments, the different commissures of the native valve (other than the commissure disposed between the non-coronary apical valve and the left coronary apical valve) may be selected commissures on which the predetermined offset between the marker and the selected commissure of the prosthetic valve is based at least in part.

[0483] Therefore, for Figure 59 and 63 The two different imaging views shown may have different predetermined offset values ​​between the radiopaque marker on the delivery device and the selected commissure of the radially compressed prosthetic valve. In some embodiments, the implantation procedure may be performed in the same manner for different imaging views (e.g., the method at 1304, 1306, 1308, and 1310 may be performed using different selected imaging views as described above), including rotatably aligning the radiopaque marker on the delivery device with the guidewire such that the marker is positioned directly behind the imaging view (e.g., as shown). Figure 61 and 60 (As shown). However, the mounting of the prosthetic valve to the delivery device can be adjusted such that different circumferential offsets between the marker and the selected commissure of the prosthetic valve are used for different procedures with different imaging views, wherein the circumferential offset determined for the selected imaging view results in the implantation of the prosthetic valve into the native valve with the commissure aligned with the commissure of the native valve.

[0484] It should be noted that Figure 62 and 63The two imaging views shown are examples of two different imaging views that can be used during a valve implant procedure to rotationally align a prosthetic valve at the native valve. However, additional different imaging views that position the target commissure of the native valve in different locations relative to the back (or front) of the selected imaging view are possible and can also be used with the systems and methods described herein. In this way, a user can select from a plurality of possible imaging views and the selected (or target) commissure (e.g., Figures 46-48 and 64 The circumferential position of the commissure 1512 shown relative to the back (or front) of the selected imaging view can be known (e.g., predetermined).

[0485] In some embodiments, different alignment rings for mounting assemblies (e.g., ring bodies similar to the ring body 1038 shown) or different indicators on the alignment rings that indicate the alignment position of one or more commissures of a prosthetic valve on an implant holder device (e.g., a support body 1010 such as Figure 45 and Figures 65-68 48 Different indicators of the alignment position of one or more commissures of a prosthetic valve on an implant holder device (e.g., a support body 1010 such as

[0486] Figure 65 Exemplary embodiments of different alignment rings that can be used in mounting assemblies and configured to rotationally align a prosthetic valve on an implant holder device resulting in the prosthetic valve being crimped onto a valve mounting portion of a delivery device in a predetermined circumferential orientation relative to radiopaque markers on a distal portion of the delivery device are shown. For example, the alignment rings can be configured such that the prosthetic valve is radially compressed onto the delivery device with a selected commissure circumferentially offset from the radiopaque markers on the distal portion of the delivery device by a predetermined amount that is determined (e.g., selected) based on a selected imaging view intended to be used during an implant procedure. In some embodiments, as shown in Figure 65 and 66 Different alignment rings can be similar in overall shape and function but have different arrangements of indicators or markers that are unique to the selected imaging view intended to be used. For example, different alignment rings having unique arrangements of indicators or markers can be configured to align a prosthetic valve on an implant holder device in such a way as to offset a selected commissure of the prosthetic valve relative to radiopaque markers on a delivery device by an appropriate amount that will align the commissure of the prosthetic valve with the native valve when the prosthetic valve is deployed from the delivery device with the radiopaque markers aligned with the guidewire as described above.

[0487] Figure 61 ​An embodiment of the alignment ring 1600 is shown, which can be configured to use a first imaging view (such as a tricuspid imaging view, e.g., Figure 46 The tricuspid valve imaging view 1500) is rotatably aligned with the prosthetic valve relative to the delivery device for the implantation procedure, so as to rotatably align and implant the prosthetic valve with the delivery device at the native valve. The alignment ring 1600 can be configured to allow the prosthetic valve to be mounted on the delivery device with the selected commissure of the prosthetic valve circumferentially offset from the radiopaque marker on the delivery device by a first predetermined amount, the first predetermined amount resulting in implantation of the prosthetic valve with the commissure aligned with the commissure of the native valve after the prosthetic valve has been deployed using the delivery device with the radiopaque marker aligned with the guidewire in its predetermined orientation (e.g., this indicates that the marker is positioned directly behind the imaging view).

[0488] Alignment ring 1600 can be configured (e.g., constructed) to align with Figure 46 and 47 The ring body 1038 is similar to or identical to the ring body 1038. For example, the alignment ring 1600 may include one or more indicators (e.g., alignment indicators or marks) 1610a-c disposed on one or more surfaces of the body 1602 of the alignment ring 1600. (See above reference...) Figure 65 and 47 As described, the indicator 1610a-c may be a recess (e.g., a groove) or etching in one or more surfaces, a raised feature extending radially outward from one or more surfaces, and / or a mark (e.g., a printed, sprayed, or stamped line) on one or more surfaces.

[0489] like Figure 48 As shown, the alignment ring 1600 includes three indicators 1610a-c spaced apart from each other around its circumference. However, in alternative embodiments, the alignment ring 1600 may include fewer than three indicators 1610a-c, such as one or two. The indicators 1610a-c can be configured to be positioned such that when the alignment ring is coupled to an implant retainer device (e.g., as shown in the image), the indicators 1610a-c are positioned ... to be positioned to be Figure 45 As shown), when a prosthetic valve is installed in an implant retainer device (e.g., such as...) Figure 65 and 48 When the support body 1010 is shown, the desired orientation of the commissure of the prosthetic valve is indicated. For example... Figure 65 As shown, the first indicator 1610a may be spaced apart from the first lever (e.g., radial extension) 1604 by a first arc length 1606.

[0490] In some embodiments, the alignment ring 1600 may include additional markers or indicators that use a tricuspid valve imaging view to indicate its intended use in aligning with the prosthetic valve to be implanted during the implantation procedure. For example, such as Figure 66As shown, the alignment ring includes a first label 1608 (“View A”) indicating a selected imaging view for the implantation procedure. In some embodiments, the selected imaging view (View A) may be the tricuspid valve imaging view described above. In alternative embodiments, the first label 1608 may be a color code, symbol, numeric code, etc.

[0491] Figure 63 Another embodiment of the alignment ring 1700 is shown, which can be configured to use a second imaging view (such as a right / left cusp overlap imaging view, e.g., Figure 46 The right / left cusp valve overlap view 1550) is rotatably aligned with the delivery device for the implantation procedure to rotatably align and implant the prosthetic valve with the delivery device at the native valve. Alignment ring 1700 can be configured to allow the prosthetic valve to be mounted on the delivery device with a second predetermined amount of circumferential offset from a radiopaque marker on the delivery device at a selected commissure portion of the prosthetic valve. This second predetermined amount results in implantation of the prosthetic valve with the commissure portion aligned with the commissure portion of the native valve after deployment of the prosthetic valve using the delivery device with the radiopaque marker aligned with the guidewire in its predetermined orientation (e.g., this indicates the marker is positioned directly behind the imaging view). The second predetermined amount may differ from the first predetermined amount described above with reference to alignment ring 1600.

[0492] Alignment ring 1700 can be configured (e.g., constructed) to align with Figure 66 and 47 The ring body 1038 is similar to or the same as the ring body 1038. For example, similar to the alignment ring 1600, the alignment ring 1700 may include one or more indicators 1710a-c arranged on one or more surfaces of the body 1702 of the alignment ring 1700.

[0493] like Figure 48 As shown, the alignment ring 1700 includes three indicators 1710a-c spaced apart from each other around its circumference. However, in alternative embodiments, the alignment ring 1700 may include fewer than three indicators 1710a-c, such as one or two. The indicators 1710a-c can be configured to, when the alignment ring is coupled to an implant retainer device (e.g., as shown in the image), Figure 45 As shown), when a prosthetic valve is installed in an implant retainer device (e.g., such as...) Figure 66 and 48 When the support body 1010 is shown, the desired orientation of the commissure of the prosthetic valve is indicated. For example... Figure 66 As shown, the first indicator 1710a may be spaced apart from the first lever (e.g., radial extension) 1704 by a second arc length 1706.

[0494] In some embodiments, the alignment ring 1700 can include additional indicia or indicators of its intended use in aligning a prosthetic valve to be implanted in an implantation procedure using a tricuspid imaging view. For example, as shown, the alignment ring includes a first label 1708 indicating a selected imaging view for an implantation procedure (“View B”). In some embodiments, the selected imaging view (View B) can be a right / left cusp overlap view as described above. In alternative embodiments, the first label 1708 can be a color code, a symbol, a numerical code, or the like. Figure 65

[0495] Figure 1 66 Two possible embodiments of individual alignment rings configured for use with different selected imaging views for valve implantation procedures as described herein are shown. However, it is also possible for additional alignment rings to be similarly configured as those shown in Figure 65 Figure 67 66 and

[0496] Figure 67 Another embodiment of an alignment ring 1800 is shown. The alignment ring 1800 can be similar to other alignment rings (or ring bodies) described herein, but includes multiple sets of indicators (e.g., alignment markers) for use with two or more implantation procedures utilizing different selected imaging views. For example, the alignment ring 1800 can be configured for intended use with two different fluoroscopy imaging views. In the example shown, Figure 68 In one embodiment, the first set of indicators 1802 can be for use with a tricuspid imaging view implantation procedure, and the second set of indicators 1804 can be for use with a different implantation procedure utilizing a right / left cusp overlap view.

[0497] In some embodiments, the first set of indicators 1802 can have a different color than the second set of indicators 1804. In this way, the differently colored indicators can correspond to different imaging views.

[0498] In other embodiments, the first set of indicators 1802 can have a different marker (e.g., line vs. dot) than the second set of indicators 1804. In other embodiments, the first set of indicators 1802 can be arranged on a first side (or surface) of the alignment ring 1800, while the second set of indicators 1804 can be arranged on an opposing second side (or surface) of the alignment ring 1800.

[0499] ​​​​Figure 68 Another embodiment of an alignment ring 1900 is shown. The alignment ring 1900 can be similar to other alignment rings (or ring bodies) described herein, but includes one or more sets of indicators 1902, each set of indicators including a plurality of graduated indicators (or markers). For example, each set of indicators 1902 can include a first (e.g., standard or base) indicator 1904, a second indicator 1906 that is circumferentially offset from the first indicator 1904 by a first amount (e.g., 10°), a third indicator 1908 that is circumferentially offset from the first indicator 1904 by a second amount (e.g., 20°), and a fourth indicator 1910 that is circumferentially offset from the first indicator 1904 by a third amount (e.g., 30°). In alternative embodiments, the sets of indicators 1902 can include more or fewer graduated markers than those shown. Figure 68

[0500] Graduated alignment rings (e.g., alignment ring 1900) having a plurality of graduated markers for one or more commissure locations can be useful for patients having atypical anatomy or for user-customized imaging views. For example, a user (e.g., a physician) can identify from pre-operative CT (or other imaging modality) that a patient has a native valve with commissures and / or coronary arteries in an abnormal (e.g., non-standard) location. Thus, a more customizable alignment ring, such as the graduated alignment ring 1900, can allow the physician to offset the prosthetic valve commissures from the more standard location. For example, the offset of the native valve commissures from the expected location can be measured in the pre-operative CT, and then the physician can request that the user offset the prosthetic valve commissures from the standard by 20° (e.g., using the third indicator 1908 shown) on the alignment ring and implant holder device. Figure 10

[0501] In this way, methods, assemblies, and / or devices for implanting a prosthetic heart valve at a native valve with circumferential alignment of the commissures of the prosthetic heart valve with the commissures of the native valve are provided. Thus, access to the coronary arteries can be increased.

[0502] In some embodiments of the delivery devices and / or methods described herein, a distal portion of the delivery device can include a valve mounting portion configured to receive a radially compressed prosthetic valve thereon and a polymer body disposed proximate the valve mounting portion. In some embodiments, the polymer body can include a radiopaque marker configured to indicate a location of a commissure of the prosthetic valve after radially expanding the prosthetic valve via inflating a balloon of the delivery device. In some embodiments, the polymer body can include a radiopaque marker configured to align with a guide wire extending through a center of the delivery device in a predetermined orientation such that the prosthetic valve is implanted with alignment of the commissure with a commissure of a native valve. ​​

[0503] In some embodiments, the methods, assemblies, and / or devices can additionally or alternatively include methods of arranging and radially compressing a prosthetic valve onto a valve mounting portion of a delivery device such that a selected commissure of the prosthetic valve is at a predetermined position and orientation relative to a radiopaque marker of the delivery device.

[0504] In some embodiments, the methods, assemblies, and / or devices can additionally or alternatively include methods of forming and / or folding a balloon of a delivery device that result in a consistent amount of rotation of a prosthetic valve during deployment of the prosthetic valve into a radially expanded state. Thus, after the balloon is inflated and radially expands the prosthetic valve, a selected commissure of the prosthetic valve can be aligned in a circumferential direction with a radiopaque marker of the delivery device and / or a target commissure of a native valve.

[0505] In some embodiments, the methods, assemblies, and / or devices can additionally or alternatively include delivery devices configured to rotate a balloon of the delivery device with a crimped (e.g., radially compressed) prosthetic valve without adversely affecting the ability of a distal portion of the delivery device to flex and / or the inflation of the balloon.

[0506] In some embodiments, the methods, assemblies, and / or devices can additionally or alternatively include delivery devices having radiopaque markers that are visible under fluoroscopy and have an asymmetric shape that allows a user to determine whether the marker is positioned in front of or behind a fluoroscopy view (e.g., as viewed by the user).

[0507] In some embodiments, the methods, assemblies, and / or devices can additionally or alternatively include methods for rotating a distal portion of a delivery device including a radiopaque marker and a radially compressed prosthetic valve during an implantation procedure to rotationally align the marker with a target commissure of a native valve into which the prosthetic valve is intended to be implanted, a predetermined position within a selected imaging view, and / or a guidewire extending through the delivery device. In some embodiments, the methods for rotating can occur during a selected portion of the implantation procedure, which reduces the likelihood of clinical complications.

[0508] In some embodiments, the methods, assemblies, and / or devices can additionally or alternatively include a method for rotationally aligning a radiopaque marker of a delivery device with a selected commissure of a native valve using a selected fluoroscopy view obtained during an implantation procedure and deploying a prosthetic valve within the native valve with the delivery device such that a selected commissure of the prosthetic valve is circumferentially aligned with the selected commissure of the native valve.

[0509] Each of the above-described features of the methods, assemblies, and / or devices can be combined with any one or more of the other above-described features of the methods, assemblies, and / or devices.

[0510] In this manner, the prosthetic valve can be more easily deployed at the implant site such that the commissures of the radially expanded prosthetic valve are aligned with the commissures of the native valve, thereby avoiding placement of the commissures of the prosthetic valve blocking and / or being positioned in front of the coronary arteries. As a result, blood flow into and access to the coronary arteries can be increased.

[0511] In some embodiments, the balloon cover can be configured to surround (e.g., encase) a distal portion of the delivery apparatus (e.g., Figure 37 and 40 a portion of the distal portion 309 of the delivery apparatus 300 shown in FIGS. 42), which includes an inflatable balloon mounted (and folded) thereon during shipping and / or storage prior to use and / or during a degassing process.

[0512] For example, prior to crimping a prosthetic valve over a balloon of a delivery apparatus, a user typically performs a cyclical “degassing” process that involves pushing inflation fluid into the balloon and then drawing the fluid out of the balloon, such as with a syringe fluidly connected to a handle of the delivery apparatus. The degassing process can be more effective when the balloon is allowed to at least partially inflate. However, inflation of the balloon outside of the balloon cover can cause the balloon to unfold, which inhibits or prevents the balloon from returning to its folded state (e.g., as shown in Figures 9-11 The balloon cover can be configured to prevent full unfolding of the balloon and / or to assist the balloon in returning to its fully folded state after inflation fluid is removed from the balloon.

[0513] Conventional balloon covers can include two housing portions or halves that are configured to be arranged around and fit together around a distal portion of a delivery device that includes a balloon (e.g., the distal portion 309 of the delivery device 300 on which the balloon 318 is mounted, as shown in Figure 41 and 40). In some embodiments, a removable sleeve can slide over and around the assembled balloon cover in order to hold (and couple) the two housing portions of the balloon cover together. When the user is ready to mount or crimp a prosthetic valve around the balloon onto the delivery apparatus (e.g., as shown in Figure 54 The user can grasp the delivery apparatus and pull to remove the sleeve from the delivery apparatus.

[0514] However, when the delivery apparatus includes a positioning apparatus coupled to a distal portion of the delivery apparatus (e.g., the positioning apparatus 1100 coupled to the distal portion 309 of the delivery apparatus 300, as shown in Figure 49 and 55 the positioning apparatus 1100 coupled to the distal portion 309 of the delivery apparatus 300, as shown in Figure 57When coupled to the distal portion of the delivery device, the positioning device 1072) as shown, the user can grasp the positioning device during removal of the sleeve from the balloon cover. For example, the user can grasp the positioning device with one hand and then slide the sleeve off the balloon cover and off the distal end of the delivery device with the other hand. This can result in movement of the positioning device relative to the delivery device (and the radiopaque markers on the distal portion of the delivery device as described herein). Thus, the prosthetic valve will subsequently be mounted onto the balloon in an improper circumferential orientation relative to the markers, which can result in misalignment of the commissures of the prosthetic valve with the commissures at the implant site or the native valve (e.g., during the implant procedure, as described above with reference to Figures 69-76B

[0515] To address such issues, a balloon cover for a balloon mounted on and around a distal portion of a delivery device can include first and second housing members, each having a narrower first portion configured to receive (and enclose within) the distal portion of the delivery device including the balloon and a wider second portion configured to receive (and at least partially enclose within) a positioning device. In this way, the second portion can surround the positioning device and prevent the user from directly contacting or grasping the positioning device, thereby avoiding any unnecessary movement (e.g., rotation) of the positioning device relative to the delivery device during removal of the balloon cover from the delivery device.

[0516] Figure 69 Embodiments of a balloon cover configured to cover a portion of a distal portion of a delivery device (e.g., the distal portion 309 of the delivery device 300, as shown in Figure 69 、 72 -76B and 108-114) including a balloon (e.g., the balloon 318) mounted thereon and a positioning device (e.g., the positioning device 1100, as shown in Figures 69-75C 、 72 -76B and 108-114) coupled to the distal portion of the delivery device proximal of the valve mounting portion of the delivery device are shown in FIGS.

[0517] Figure 72 An exemplary embodiment of such a balloon cover (or balloon cover assembly) 2000 is shown, which includes a first cover portion 2001 and a second cover portion 2003 Figure 69 and 73 ​The first cover portion 2001 is configured to cover at least a portion of a distal portion of a delivery device including a balloon, and the second cover portion 2003 is configured to cover a positioning device. The balloon cover 2000 can include a first housing member 2002 and a second housing member 2004 configured to matingly engage one another and removably couple to one another. For example, the first housing member 2002 and the second housing member 2004 can include two halves of an outer housing 2006 of the balloon cover 2000 and / or form the outer housing 2006 of the balloon cover 2000. Figure 69

[0518] The outer housing 2006 and the balloon cover 2000 are shown in an exploded configuration in an exploded view of Figures 72-75C and in an assembled configuration in various views of Figure 70 . Figure 70 The first housing member 2002 is shown detached from the remainder of the balloon cover 2000. However, since the first housing member 2002 and the second housing member 2004 can be configured to be identical (e.g., identically formed) in some embodiments, the first housing member 2002 shown can instead be the second housing member 2004. Figures 71A-71C Additionally, Figure 71C detailed views of a mating interface 2008 between the first housing member 2002 and the second housing member 2004 Figures 71A-71C and related mating interface features or members of the first housing member 2002 and the second housing member 2004 Figure 70 are shown.

[0519] Each of the first housing member 2002 and the second housing member 2004 includes a first portion (e.g., a first housing portion) 2010 and a second portion (e.g., a second housing portion) 2012. In some embodiments, the first portion 2010 and the second portion 2012 of one of the first housing member 2002 and the second housing member 2004 can be continuous with one another (e.g., formed as one piece). In some embodiments, the second portion 2012 can have a second width 2018 that is greater than a first width 2016 of the first portion 2010 Figure 69 In some embodiments, the first width 2016 and the second width 2018 can be diameters.

[0520] ​When the first housing member 2002 and the second housing member 2004 are assembled together (e.g., in a mating engagement), the first portions 2010 of the first housing member 2002 and the second housing member 2004 can form the first cover portion 2001 and define an elongated lumen 2020 (which can be referred to as a luminal cavity in some embodiments). The lumen 2020 can be configured to receive a distal end portion of a delivery device and a balloon mounted on the distal end portion of the delivery device (e.g., the balloon 318 of the distal end portion 309 of the delivery device 300, as shown in FIGS. 30-31). Figure 69 and 72 -75C) of the balloon 318 (e.g., a majority of the balloon 318 in some embodiments).

[0521] For example, the first portion 2010 of the first housing member 2002 (and similarly, the first portion 2010 of the second housing member 2004) includes an outer surface 2022 ( Figure 70 and 70 ) and an inner surface 2024 ( Figure 70 ). The inner surface 2024 can be a mating surface that is configured to matingly or matingly engage (e.g., be in face-to-face contact with) a corresponding inner surface of the first portion 2010 of the other (e.g., second) housing member to form the balloon cover 2000. In some embodiments, the inner surface 2024 can be a planar surface.

[0522] The first portion 2010 can further include a recess 2026 recessed into the inner surface 2024 (toward the outer surface 2022). The recesses 2026 of the first housing member 2002 and the second housing member 2004 can together form the lumen 2020. Thus, each recess 2026 of each of the first housing member 2002 and the second housing member 2004 can define a half-luminal portion 2021 ( Figure 70 ) of the lumen 2020.

[0523] Each recess 2026 can be shaped to receive a portion of the distal end portion 309 of the delivery device. For example, each recess 2026 can include a distal segment 2028, a proximal segment 2030, and an intermediate segment 2032 disposed between the distal segment 2028 and the proximal segment 2030 ( Figures 69-75C ).

[0524] In some embodiments, the distal segment 2028 can be shaped (e.g., configured) to receive a balloon (e.g., the balloon 318) and a portion of the delivery device covered by the balloon. For example, in the embodiment shown in FIGS. 30-31, the distal segment 2028 can be shaped to receive a portion of the nosecone 322 and a distal end portion 332 of the balloon 318 covering the distal shoulder 326 of the delivery device 300. Figure 70

[0525] ​In some embodiments, the intermediate section 2032 can be shaped (e.g., configured) to receive the middle portion 335 of the balloon and the portion of the delivery device 300 (e.g., the valve mounting portion 324) covered by the middle portion 335.

[0526] In some embodiments, the proximal section 2030 can be shaped (e.g., configured) to receive at least a distal portion of the proximal end portion 333 of the balloon 318. In some embodiments, a more proximal portion of the proximal end portion 333 of the balloon 318 can extend into the second portion 2012 of the first housing member 2002 or the second housing member 2004 Figure 70 and 72 ). In other embodiments, the proximal section 2030 can be shaped to receive the entire proximal end portion 333 of the balloon 318.

[0527] In this way, the shape or profile of the recess 2026 can vary along a first length 2034 of the first portion 2010, which extends in an axial direction relative to the central longitudinal axis 2014 Figure 70 . For example, as shown in FIG. 20, the intermediate section 2032 is narrower than each of the distal section 2028 and the proximal section 2030. In some embodiments, the width of the intermediate section 2032 is constant along a majority of the length of the intermediate section 2032. Figures 108-114

[0528] In other embodiments, each recess 2026 can include a distal section 2028 and a proximal section that can be similar to the intermediate section 2032 and extend from the distal section 2028 to the second portion 2012. In such embodiments, the proximal section can be configured to receive the middle portion 335 of the balloon and the portion of the delivery device 300 (e.g., the valve mounting portion 324) covered by the middle portion 335. In some embodiments, the proximal section can be further configured to receive the proximal end portion 333 of the balloon 318 that can not have a portion of a diameter wider than the middle portion 335 when disposed within the balloon cover 2000. In Figure 69 such embodiments, the proximal section can be configured to receive the proximal end portion 333 of the balloon 318 that can have a portion of a diameter wider than the middle portion 335 when disposed within the balloon cover 2000. In

[0529] In some embodiments, the first length 2034 of the first portion 2010 can be longer than the second length 2036 of the second portion 2012.

[0530] In other embodiments, the second length 2036 of the second portion 2012 can be the same as or longer than the first length 2034 of the first portion 2010.

[0531] ​In some embodiments, the second length 2036 of the second portion 2012 can be selected based on a length and / or dimension of a positioning device (e.g., the positioning device 1100) contained within the second portion 2012 of the first housing member 2002 and the second housing member 2004 when the first housing member 2002 and the second housing member 2004 of the second portion 2012 are coupled together in a mating engagement. For example, in some embodiments, the second length 2036 can be the same as or longer than a length of the positioning device 1100. In some embodiments, the second length 2036 can be shorter than a length of the positioning device 1100, but long enough to cover enough of the positioning device (e.g., a majority of the positioning device or a wider or larger diameter portion) such that the user is discouraged or prevented from grasping onto the positioning device 1100.

[0532] When the first housing member 2002 and the second housing member 2004 are assembled to one another (e.g., coupled together in a mating engagement), the second portions 2012 of the first housing member 2002 and the second housing member 2004 can form a second cover portion 2003 and define a cavity 2038 Figure 69 and 72 -75A). The cavity 2038 can be configured to receive a positioning device (e.g., the positioning device 1100, as shown in Figure 70 and 72 -75C) mounted on the distal end portion 309 of the delivery device 300 proximally of the valve mounting portion 324 of the distal end portion 309.

[0533] An inner surface of the wall of the second portion 2012 can define one half-cavity portion 2040 Figure 70 of the cavity 2038. For example, as shown in Figures 69-75C , the second portion 2012 of the first housing member 2002 (and the second housing member 2004) can be defined by a first wall 2050, a second wall 2052, a third wall 2054, and a fourth wall 2056. The first wall 2050 can be relatively planar, and the central longitudinal axis 2014 can be perpendicular to the first wall 2050. The second wall 2052 and the third wall 2054 can be curved (as shown in Figure 76A ). The fourth wall 2056 can be relatively planar and disposed perpendicular to the first wall 2050. In some embodiments, the fourth wall 2056 can define an opening (which can also be referred to herein as a window) 2046 and extend between the second wall 2052 and the third wall 2054 (e.g., in a circumferential direction or in a direction perpendicular to the central longitudinal axis 2014).

[0534] In other embodiments, as described below with reference to Figure 70 and 76BAs further explained, the second portion 2012 can not include the fourth wall 2056 (and the opening 2046), but rather the second wall 2052 and the third wall 2054 can be continuous with one another (e.g., forming one continuous curved wall, forming a complete half-cylinder).

[0535] Each wall of the second portion 2012 can include an inner surface and an outer surface. For example, the first wall 2050 can have a first inner surface 2042, the second wall 2052 can have a second inner surface 2044, the third wall 2054 can have a third inner surface 2043, and the fourth wall 2056 can have a fourth inner surface 2048 Figure 69 ). The first inner surface 2042, the second inner surface 2044, the third inner surface 2043, and the fourth inner surface 2048 can define the half-cavity portion 2040.

[0536] As shown in FIGS. 20A and 20B, in some embodiments, the recess 2026 can extend to the first inner surface 2042. In this way, the recess 2026 can be continuous from the first inner surface 2042 to the distal end of the first portion 2010. Figure 71C and 70 As shown in FIGS. 20A and 20B, in some embodiments, the recess 2026 can extend to the first inner surface 2042. In this way, the recess 2026 can be continuous from the first inner surface 2042 to the distal end of the first portion 2010.

[0537] In some embodiments, the second inner surface 2044 and the third inner surface 2043 are both curved and together form the half-cylindrical shape of the second portion 2012. In some embodiments, the second inner surface 2044 and the first inner surface 2042 are separated from one another by the opening 2046 and connected together at the proximal end of the second portion 2012 by the fourth inner surface 2048.

[0538] The second portion 2012 of the first housing member 2002 (and similarly, the second housing member 2004) can further include a mating surface 2058 configured to mate with a corresponding mating surface of the second housing member 2004 (as shown in FIG. 20B). The mating surface 2058 can be formed along the edges of the first wall 2050, the second wall 2052, and the third wall 2054. Figure 71A

[0539] In some embodiments, the mating surface 2058 of the second portion 2012 can be continuous with (and / or in the same plane as) the inner surface 2024 of the first portion 2010. In this way, the inner surface 2024 and the mating surface 2058 can form the entire mating surface of the first housing member 2002 or the second housing member 2004.

[0540] ​In some embodiments, the mating surface 2058 can be planar or relatively planar and include a first mating element and a second mating element, in some embodiments, the first mating element can be configured as a protrusion (or tongue) 2060 extending along a first portion of the mating surface 2058 (e.g., on a first side of the mating surface 2058 relative to the central longitudinal axis 2014), in some embodiments, the second mating element can be configured as a groove (or recess) 2062 extending along a second portion of the mating surface 2058 (e.g., on a second side of the mating surface 2058 opposite the first side relative to the central longitudinal axis 2014). In Figure 71B a detailed view of the first portion of the mating surface 2058 including the protrusion 2060 is shown in Figure 71C a detailed view of the second portion of the mating surface 2058 including the groove 2062 is shown. The protrusion extends outwardly from the mating surface 2058, and the groove 2062 is recessed into the mating surface 2058.

[0541] Figure 71C is a detailed view of the mating interface 2008 between the protrusion 2060 of the first housing member 2002 (e.g., on the first portion of the mating surface 2058 of the first housing member 2002) and the groove 2062 of the second housing member 2004 (e.g., on the second portion of the mating surface 2058 of the second housing member 2004). As Figures 72-75C shown, in some embodiments, the respective mating surfaces 2058 of the respective second portions 2012 of the first housing member 2002 and the second housing member 2004 can be positioned against one another (e.g., in face-to-face contact), and the protrusion 2060 of the first housing member 2002 can extend into (and interface or mate with) the groove 2062 of the second housing member 2004. The inverse of this mating engagement can occur at the second portions of the mating surfaces 2058 of the first housing member 2002 and the second housing member 2004 (e.g., on opposite sides of the balloon cover 2000, the protrusion 2060 of the second housing member 2004 can extend into and interface or mate with the groove 2062 of the first housing member 2002).

[0542] In other embodiments, the mating interface 2008 between the first and second housing members 2002, 2004 can be variously configured with different interlocking or docking mating features (e.g., such as other lock-key or complementary features). In some embodiments, the mating interface 2008 between the first and second housing members 2002, 2004 can have different protrusion and recess interlocking features, such as protrusions of different shapes (e.g., triangular in cross-section or a series of spaced apart protrusions) and corresponding shaped recesses or recesses.

[0543] The configuration of the mating interface 2008 as described above can prevent the first and second housing members 2002, 2004 from sliding past one another when the assembled balloon cover 2000 is grasped or manipulated by a user.

[0544] Once assembled in mating engagement (as shown in Figure 69 , the first and second housing members 2002, 2004 can be held or coupled together via a coupling element (e.g., such that they cannot be pulled apart from one another). In some embodiments, as shown in Figure 72 , 72 , 73 and 75A, the coupling element can be configured as a sleeve 2064. In some embodiments, the sleeve 2064 can be tubular and configured to slide over and around the first portions 2010 of the first and second housing members 2002, 2004 that are mated together. For example, the sleeve 2064 can be configured to hold the first and second housing members 2002, 2004 in mating engagement with one another. Thus, the balloon cover 2000 can be held together (and installed) over and around the distal end portion 309 of the delivery device.

[0545] As described above and as shown in Figure 72 and 73 , when assembled together, the first portions 2010 of the first and second housing members 2002, 2004 can cover and enclose therein a portion of the distal end portion 309 of the delivery device and the balloon 318. In some embodiments, the portion of the delivery device covered by the first portions 2010 of the balloon cover 2000 can include a portion of the nose cone 322, the distal shoulder 326, the valve mounting portion 324, and a portion of the inner shaft 308 around which the proximal end portion 333 of the balloon 318 is disposed, as well as a portion of the balloon 318 covering these portions of the delivery device Figure 72 .

[0546] Additionally, as shown in Figure 72 and 73As shown, the second portions 2012 of the first and second housing members 2002, 2004, when assembled together, can cover and enclose a positioning device (e.g., the positioning device 1100) mounted on the distal end portion 309 of the delivery apparatus proximally of the valve mounting portion 324 of the distal end portion 309 of the delivery apparatus when assembled together.

[0547] In some embodiments, the second portions 2012 of the first and second housing members 2002, 2004 can cover and enclose the entire positioning device 1100. In other embodiments, the second portions 2012 of the first and second housing members 2002, 2004 can cover and enclose most of the positioning device 1100 (e.g., all but the most proximal portion, as shown in FIG. 21). Figure 72 and 72 As shown).

[0548] When assembled together, the second portions 2012 of the first and second housing members 2002, 2004 can form a closed distal end 2066 Figures 72-75C , 73 and an open proximal end 2068 Figures 74-75C ). For example, the closed distal end 2066 can be formed by the outer surfaces 2070 of the first walls 2050 of the first and second housing members 2002, 2004.

[0549] In other embodiments, the distal end 2066 can be at least partially open, having one or more openings or windows in the first wall 2050 of the first and / or second housing members 2002, 2004.

[0550] Additionally, in some embodiments (as shown in FIG. 22), the open proximal end 2068 can be formed by the edge portions 2072 of the second and third walls 2052, 2054 of each of the first and second housing members 2002, 2004. Figure 74

[0551] In other embodiments, the proximal end 2068 can be at least partially closed. For example, in such embodiments, the edge portions 2072 can extend radially inward to form a partial (e.g., incompletely enclosing) wall.

[0552] The first portions 2010 of the first and second housing members 2002, 2004 extend distally in the axial direction from the closed distal end 2066.

[0553] ​The outer surface of the wall of the second portion 2012 of the first housing member 2002 and the second housing member 2004 can form the second cover portion 2003 of the balloon cover 2000 and can provide a surface for a user to grasp and / or hold onto when sliding the sleeve 2064 off the first portion 2010 (such that the balloon cover 2000 can be removed from the delivery device).

[0554] When the second portions 2012 of the first housing member 2002 and the second housing member 2004 are assembled to form the second cover portion 2003, a cylindrical housing (e.g., a cylinder) can be formed. The interior dimensions of the cylindrical housing can define the cavity 2038. For example, the second cover portion 2003 can have an inner diameter 2074 and an inner height 2076 Figure 74 and 75B ). The inner height 2076 can be defined between the fourth inner surface 2048 of the fourth wall 2056 of the first housing member 2002 and the fourth inner surface 2048 of the fourth wall 2056 of the second housing member 2004 Figure 74 ). The inner diameter 2074 can be defined between the oppositely arranged curved walls (e.g., the second walls 2052, as shown in Figure 75B ).

[0555] As shown in Figure 75C and 75C , the inner diameter 2074 and the inner height 2076 can be selected according to the maximum dimensions of the positioning device contained within the cavity 2038. For example, the inner diameter 2074 and the inner height 2076 can be selected such that the flange portion 1112 of the positioning device 1100 fits within the cavity 2038 without touching (e.g., spaced apart from) the second inner surface 2044 and the third inner surface 2043 of the first housing member 2002 and the second housing member 2004. For example, the inner diameter 2074 can be greater than the outer diameter of the flange portion 1112.

[0556] In some embodiments, the inner height 2076 can be the same as or slightly smaller than the outer diameter of the flange portion 1112. For example, in some embodiments, as shown in Figure 57 , one or more portions of the flange portion 1112 of the positioning device 1100 (e.g., the extension portion 1114) can extend into one of the openings 2046 (e.g., between the fourth inner surface 2048 and the outer surface of the fourth wall 2056).

[0557] Therefore, when the user grasps the outside of the second cover portion 2003 (e.g., to remove sleeve 2064), any movement of the balloon cover 2000 will not cause movement of the positioning device 1100 relative to the delivery device, because the balloon cover 2000 does not directly contact the positioning device 1100. For example, if the balloon cover 2000 rotates, this rotation will not cause rotation of the positioning device 1100, thus maintaining the positioning device in the designated and intended circumferential position relative to the delivery device. This allows the prosthetic valve to be mounted on the valve mounting portion of the delivery device in a predetermined circumferential orientation relative to a radiopaque marking on the delivery device, as discussed herein (e.g., as referenced above). Figures 74-75C (As discussed).

[0558] In some embodiments, such as Figure 75B As shown, the inner height 2076 can be less than the inner diameter 2074. Correspondingly, the second covering portion 2003 can have an outer height 2078 that is less than the outer diameter 2080. Figure 76A The reduced inner height 2076 and outer height 2078 of the second cover portion 2003 compared to its corresponding diameter can reduce the overall encapsulation space of the balloon cover 2000. This can reduce the material cost of the balloon cover itself and the encapsulation material used to contain the balloon cover. Therefore, the inner diameter 2074 and inner height 2076 can be selected to be as small as possible to reduce the encapsulation space, while still being large enough to prevent engagement with the positioning device (Figure 76C).

[0559] In some embodiments, the configuration of the opening 2046 in the fourth wall 2056 of the first housing member 2002 and the second housing member 2004 may result in a reduced inner height 2076 and outer height 2078.

[0560] In some embodiments, the opening 2046 may also allow the user to visualize the positioning device 1100 and the distal portion 309 of the delivery device 300, which may allow for easier assembly of the balloon cover 2000 around the delivery device.

[0561] In other embodiments, the second cover portion 2003 may be cylindrical, and the first housing member 2002 and the second housing member 2004 may have walls that completely enclose the positioning device without any openings. For example, ​ and 76B Another exemplary embodiment of a balloon cover 2100 is shown, the balloon cover 2100 including a first outer shell member 2102 and a second outer shell member 2104 configured to engage with each other and be removably coupled to each other.

[0562] The first outer shell component 2102 and the second outer shell component 2104 can be coupled with the balloon cover 2000.Figures 69-75C The first and second housing members 2002 and 2004 of the balloon cover 2000 are similarly configured, except that the first and second housing members 2102 and 2104 do not include the opening 2046 and the inner and outer diameters 2106 and 2108 of the second cover portion 2110 (similar to the second cover portion 2003) are constant around the circumference of the second cover portion 2110. Figure 76B Thus, the second cover portion 2110 does not have a reduced height (as compared to the balloon cover 2000). Thus, the balloon cover 2100 Figures 69-75C may increase the packing space as compared to the balloon cover 2000 Figure 76A and 76B .

[0563] Figures 108-114 Another embodiment of a balloon cover 2600 is shown, which is configured to cover a portion of a distal end portion of a delivery device (e.g., the distal end portion 309 of the delivery device 300) that includes an inflatable balloon (e.g., the balloon 318) mounted thereon and a positioning device coupled to the distal end portion of the delivery device proximal of a valve mounting portion of the delivery device. The balloon cover 2600 can be similar to the balloon cover 2000 of Figures 69-75C , except that it is configured to receive a portion of the positioning device and prevent rotation of the positioning device and the balloon cover 2600 relative to each other. For example, independent rotation between the positioning device and the balloon cover 2600 can result in twisting of the balloon, causing unpredictable rotation of the prosthetic heart valve (and thus uncertainty in positioning of the prosthetic valve commissures relative to the native valve commissures) during deployment of the valve at the implant site.

[0564] The balloon cover 2600 includes a first cover portion 2601 configured to cover at least a portion of the distal end portion of the delivery device that includes the balloon and a second cover portion 2603 configured to cover the positioning device. The balloon cover 2600 can include a first housing member 2602 and a second housing member 2604 that are configured to matingly engage each other and removably couple to each other Figure 110 and 113 . For example, the first and second housing members 2602 and 2604 can include an outer housing 2606 of the balloon cover 2600 and / or form two halves of the outer housing 2606 of the balloon cover 2600 Figure 110 .

[0565] The outer housing 2606 and the balloon cover 2600 are shown in an exploded configuration in an exploded view of Figure 110 , and in an assembled configuration in a perspective view of Figure 108 ,109 each of the various views of 110 and 113. Further, Figure 113 a cross-sectional view of the balloon cover 2600 is shown, while Figure 114 one of the housing members (e.g., the first housing member 2602) disposed about the delivery apparatus is shown.

[0566] In some embodiments, the first housing member 2602 and the second housing member 2604 can have a mating interface 2008 similar or identical to the mating interface described above with reference to Figures 71A-71C

[0567] The first housing member 2602 and the second housing member 2604 each include a first portion (e.g., a first housing portion) 2610 and a second portion (e.g., a second housing portion) 2612. In some embodiments, the first portion 2610 and the second portion 2612 of one of the first housing member 2602 and the second housing member 2604 can be continuous with one another (e.g., formed as one piece). Similar to the balloon cover 2000, the second portion 2612 of the balloon cover 2600 can have a greater width than the first portion 2610.

[0568] When the first housing member 2602 and the second housing member 2604 are assembled together (e.g., in mating engagement), the first portions 2610 of the first housing member 2602 and the second housing member 2604 can form a first cover portion 2601 and define an elongated cavity 2620 Figure 110 and 113 ). The cavity 2620 can be configured to receive a distal portion of a delivery apparatus and at least a portion (e.g., in some embodiments, a majority) of a balloon mounted on the distal portion of the delivery apparatus (e.g., the balloon 318 of the distal portion 309, as shown in Figure 110 、 113 and 114).

[0569] For example, the first portion 2610 of the first housing member 2602 (and similarly, the first portion 2610 of the second housing member 2604) includes an outer (radially outwardly facing) surface 2622 Figure 110 、 112 and 113) and an inner (radially inwardly facing) surface 2624 Figure 110 and 114 ). The inner surface 2624 can be a mating or matingly engageable surface configured to mate or matingly engage (e.g., be in face-to-face contact with) a corresponding inner surface of the first portion 2610 of the other (e.g., second) housing member to form the balloon cover 2600. In some embodiments, the inner surface 2624 can be a planar surface.

[0570] ​In some embodiments, one of the housing components (the second housing component 2604, such as...) Figure 110 and 112 The first portion 2610 (shown) may include a hole or window 2660 configured to pass through an outer surface 2622 and an inner surface 2624, and positioned such that when the balloon cover is coupled to the delivery device, a marking 600 on the distal shoulder (or other markings on the distal portion of the delivery device) can be visualized by the user, as described herein.

[0571] The first part 2610 may further include (facing the outer surface 2622, Figure 110 and 114 The recess 2626 is recessed into the inner surface 2624. The recesses 2626 of the first outer shell member 2602 and the second outer shell member 2604 can together form a cavity 2620.

[0572] Each recess 2626 may be shaped as part of the distal portion 309 of the receiving and delivery device. For example, each recess 2626 may include a distal segment 2628 and a proximal segment 2630. Figure 110 In some embodiments, the distal segment 2628 may be shaped (e.g., configured) as a portion of a receiving balloon (e.g., balloon 318) and a delivery device covered by the balloon. For example, in Figures 108-114 In the illustrated embodiment, the distal segment 2628 may be shaped as a portion of the receiving nasal cone 322 and the distal portion 332 of the balloon 318 covering the distal shoulder 326 of the delivery device 300. Figure 110 , 113 and 114).

[0573] In some embodiments, the proximal segment 2630 may be shaped (e.g., configured) to receive the middle portion 335 of the balloon and a portion of the delivery device 300 (e.g., valve mounting portion 324) covered by the middle portion 335. In some embodiments, the proximal segment 2630 may also be shaped to receive at least the distal portion of the proximal portion 333 of the balloon 318, but in Figures 108-114 In the illustrated embodiment, the proximal portion 333 of the balloon 318 may have the same profile or diameter as the intermediate portion 335. Therefore, the proximal segment 2630 may have a constant or relatively constant width along its length (or most of its length) from the distal segment 2628 to the second portion 2612 of the outer shell member. In other embodiments, each recess 2626 may be shaped similar to... Figures 69-75C The indentation 2026 of the balloon cover 2000 is shown.

[0574] In this way, the shape or contour of the recess 2626 can be changed along the length of the first portion 2610. For example, asFigure 110 , 113 As shown in Figure 114, the proximal segment 2630 is narrower than the distal segment 2628.

[0575] In some embodiments, the length of the first portion 2610 may be longer than the length of the second portion 2612, as referenced above. Figures 69-75C Described.

[0576] The second portion 2012 of each of the first housing member 2602 and the second housing member 2604 may be configured (sized and shaped) based on the length and / or size of the positioning device (e.g., positioning device 1100) so that it is contained within the second portion 2612 of the first housing member 2602 and the second housing member 2604 when the second portions 2612 of the first housing member 2602 and the second housing member 2604 are coupled together in a mating engagement manner.

[0577] When the first housing member 2602 and the second housing member 2604 are assembled to each other (e.g., coupled together in a mating engagement manner), the second portions 2612 of the first housing member 2602 and the second housing member 2604 can form the second cover portion 2603 and define the cavity 2638. Figure 108 and 111 -114). Cavity 2638 can be configured to receive a positioning device (e.g., positioning device 1100, such as) proximal to the valve mounting portion 324 of the distal portion 309 mounted on the distal portion 309 of the delivery device 300. Figures 108-114 As shown), in some embodiments, apart from one or more cavities 2652 further described below, the overall size of cavity 2638 may be similar to cavity 2038 of balloon cover 2000 as described above.

[0578] Similar to balloon cover 2000 ( Figures 69-75C The inner surface of the wall of the second portion 2612 may define a half-cavity portion of the cavity 2638. In some embodiments, the second portion 2612 of the second outer shell member 2604 may be configured to be the same as or similar to the second portion 2012 of the first outer shell member 2002 and the second outer shell member 2004 of the balloon cover 2000 (see above). Figures 69-75C (Description of the first housing member 2602). However, the second portion 2612 of the first housing member 2602 may have a first wall 2650 (a wall connected to the first portion 2610), the first wall 2650 being shaped (e.g., bonded) as part of receiving the positioning device 1100. For example, the first wall 2650 of the second portion 2612 of the first housing member 2602 may be shaped to form one or more cavities 2652, said one or more cavities 2652 being shaped to receive and retain a portion of the flange portion 1112 of the positioning device 1100 therein.Figure 110 、 113 and 114). In some embodiments, the second portion 2612 of the first housing member 2602 can include one or more protruding wall portions 2654 that are part of or extend from the first wall 2650 to protrude into the cavity 2638 and form one or more cavities 2652 Figure 108 、 110 , 113 and 114).

[0579] By configuring the first wall 2650 of the second portion 2612 of the first housing member 2602 to have one or more cavities 2652, rotation of the positioning device 1100 and the balloon cover 2600 relative to each other is prevented when the balloon cover 2600 is coupled to the delivery device and around the positioning device 1100. As a result, twisting of the balloon 318 can be avoided.

[0580] In some embodiments, one of the housing portions of any other balloon cover described herein (e.g., with reference to Figures 69-86 ) can have a second portion that includes one or more cavities 2652 shaped to receive and hold a portion of the flange portion 1112 of the positioning device 1100 therein, as described above with reference to Figures 108-114 .

[0581] Returning to Figures 108-114 , the remaining walls of the second portion 2612 of the first housing member 2602 can be similar to the walls of the second housing member 2604. As described above with reference to the balloon cover 2000, the second portion 2612 of the balloon cover 2600 can define an opening 2646.

[0582] Once assembled in mating engagement (as shown in Figure 108 、 109 and 111-113), the first housing member 2602 and the second housing member 2604 can be held or coupled together via a coupling element (e.g., such that they cannot be pulled apart from each other). In some embodiments, the coupling element can be configured as a sleeve 2664. The sleeve 2664 can be configured the same as or similar to the sleeve 2064 of the balloon cover 2000.

[0583] As described above, when assembled together, the first portion 2610 of the first housing member 2602 and the second housing member 2604 can cover and enclose a portion of the distal end portion 309 of the delivery device and the balloon 318 Figure 108 、 109and 111-114). In some embodiments, the portion of the delivery device covered by the first portion 2610 of the balloon cover 2600 can include a portion of the nose cone 322, the distal shoulder 326, the valve mounting portion 324, and a portion of the inner shaft 308, as well as a portion of the balloon 318 covering these portions of the delivery device Figure 113 and 114 ).

[0584] Similar to the description above with reference to Figures 69-75C , the outer surface of the wall of the second portion 2612 of the first housing member 2602 and the second housing member 2604 can form the second cover portion 2603 of the balloon cover 2600 and can provide a surface for a user to grab and / or hold onto when sliding the sleeve 2664 off the first portion 2610 (such that the balloon cover 2600 can be removed from the delivery device) without having to grab the positioning device 1100.

[0585] As introduced above with reference to Figures 38-41 , the distal end portion 309 of the delivery device 300 can include a distal tip portion 900 mounted on or disposed at the distal end of the outer shaft 304. In some embodiments, after a prosthetic valve is mounted around the valve mounting portion 324 of the delivery device 300 in a radially compressed state, the outer shaft 304 and the intermediate shaft (e.g., balloon shaft) 306 are able to move axially relative to each other such that the distal tip portion 900 is disposed over the proximal end portion 333 of the balloon 318. Thus, the distal tip portion 900 can act as a proximal shoulder on the proximal side of the valve mounting portion 324 and prevent the radially compressed prosthetic valve from moving proximally in the axial direction during advancement of the distal end portion of the delivery device to a target implantation site.

[0586] As previously described, prior to crimping the prosthetic valve around the valve mounting portion 324, the balloon 318 can undergo a cyclical outgassing process whereby inflation fluid is introduced into the balloon and then withdrawn from the balloon. The process of introducing inflation fluid into the balloon 318 and then withdrawing the inflation fluid can be repeated one or more times as desired. During the outgassing process, the distal tip portion 900 is typically positioned proximally of the balloon 318 (e.g., away and distal from the proximal end portion 333 of the balloon 318) to facilitate the flow of inflation fluid into the proximal end portion 333 of the balloon 318. In some embodiments, the outgassing process can be performed while the balloon 318 is contained within the balloon cover. After the outgassing process, the balloon cover can be removed from the balloon and the outer shaft 304 can be moved axially relative to the intermediate shaft 306 (and the inner shaft 308) to a more distal position extending over the proximal end portion 333 of the balloon 318 (as shown in FIG. 3B) prior to crimping the prosthetic valve around the valve mounting portion 324. Figure 41As the distal tip portion 900 moves distally over the proximal portion 333, residual fluid in the proximal portion 333 of the balloon from the degassing process can be distally pushed into the middle portion 335 and the distal portion 332 of the balloon 318.

[0587] As described above, in order to accommodate this residual fluid without increasing the curled profile of the prosthetic valve on the delivery device, a radial recess 334 can be initially formed in the distal portion 332 of the balloon 318 (e.g., before the distal apical portion 900 is moved over the proximal portion 333 of the balloon 328). Figure 40 When residual expansion fluid in the proximal portion 333 of balloon 318 is "squeezed" or pushed into the distal portion 332 of balloon 318 by advancing the distal apical portion 900, the displaced residual fluid can displace the distal portion 332 of balloon 318 from... Figure 40 The radial concave state shown expands to Figure 41 As shown (and in Figure 40 The extended state 924 (shown in dashed lines) is thus avoided. Therefore, undesirable expansion of the intermediate portion 324, which would otherwise cause the curled contour of the prosthetic valve to expand, can be avoided.

[0588] Various technologies and institutions can be used to achieve this. Figure 40 The balloon shape shown includes a balloon cover having an inner cavity shaped to produce a desired balloon shape (e.g., radial recess 334).

[0589] Figures 77-83B An exemplary embodiment of a balloon cover 2200 is shown, which is configured to receive (and cover) a distal portion of a delivery device (e.g., distal portion 309 of delivery device 300, such as a balloon 318) comprising an inflatable balloon (e.g., balloon 318) mounted thereon. Figure 77 Part of the balloon cover 2200. In some embodiments, the balloon cover 2200 is configured to additionally receive a positioning device (e.g., positioning device 1100, such as...) that is proximal to the valve mounting portion of the delivery device and coupled to the distal portion of the delivery device. Figures 53-55 (as shown in Figure 77).

[0590] More specifically, the balloon cover 2200 is configured to receive and produce a specific final shape of the balloon 318 (e.g., such as...). Figure 40 The shape shown includes a radial recess 334. For example... Figure 77 This is an exploded view of a balloon cover 2200 configured to be assembled around the distal portion 309 of a delivery device 300. Figure 83A and 83BA cross-sectional view of the assembled balloon cover 2200 is shown in FIG. 22. As described more fully below, the balloon cover 2200 can be similar to the balloon cover 2100 described above with reference to FIG. 21, except that a recessed sleeve configured to receive the distal portion 332 of the balloon 318 and a first cavity configured to receive the middle portion 335 and the proximal portion 333 of the balloon 318 (formed by recesses of the housing members) are added. Figures 69-75C A cross-sectional view of the assembled balloon cover 2200 is shown in FIG. 22. As described more fully below, the balloon cover 2200 can be similar to the balloon cover 2100 described above with reference to FIG. 21, except that a recessed sleeve configured to receive the distal portion 332 of the balloon 318 and a first cavity configured to receive the middle portion 335 and the proximal portion 333 of the balloon 318 (formed by recesses of the housing members) are added.

[0591] As shown in FIGS. 22-26, the balloon cover (or balloon cover assembly) 2200 includes a first cover portion 2201 configured to cover at least a portion of a distal portion of a delivery device including a balloon. The balloon cover 2200 can further include a second cover portion 2203 configured to cover a positioning device (and / or a portion of the delivery device including a balloon). Figure 77 and 83A As shown in FIGS. 22-26, the balloon cover (or balloon cover assembly) 2200 includes a first cover portion 2201 configured to cover at least a portion of a distal portion of a delivery device including a balloon. The balloon cover 2200 can further include a second cover portion 2203 configured to cover a positioning device (and / or a portion of the delivery device including a balloon). Figure 77 and 83A As shown in FIGS. 22-26, the balloon cover (or balloon cover assembly) 2200 includes a first cover portion 2201 configured to cover at least a portion of a distal portion of a delivery device including a balloon. The balloon cover 2200 can further include a second cover portion 2203 configured to cover a positioning device (and / or a portion of the delivery device including a balloon).

[0592] The balloon cover 2200 can include a first housing member 2202 and a second housing member 2204 configured to matingly engage one another and removably couple to one another (similar to the first housing member 2002 and the second housing member 2004 of the balloon cover 2000). For example, the first housing member 2202 and the second housing member 2204 can comprise two halves of a housing 2206 of the balloon cover 2200 (similar to the first housing member 2002 and the second housing member 2004 of the balloon cover 2000). Figure 77 , 83A and 83B).

[0593] The balloon cover 2200 can further include a recessed sleeve 2240 (which can also be referred to as a recessed cap, member, or tube). The recessed sleeve 2240 can be configured to form a shape (e.g., a concave or recessed shape) of a portion of a balloon of a delivery device (e.g., the radial recess 334 in the distal portion 332 of the balloon 318). The recessed sleeve 2240 is described in further detail below with reference to various views of FIGS. 22-26. Figures 78-81B The recessed sleeve 2240 can be configured to form a shape (e.g., a concave or recessed shape) of a portion of a balloon of a delivery device (e.g., the radial recess 334 in the distal portion 332 of the balloon 318).

[0594] In some embodiments, the balloon cover 2200 can further include a coupling element, which in some embodiments can be a tubular sleeve (e.g., an outer sleeve) 2264 configured to cover at least a portion of the recessed sleeve 2240 and cause one or more recessed members 2256 of the recessed sleeve 2240 to recess in a radially inward direction toward the central longitudinal axis 2214 so as to form a negative recess in one or more portions of the balloon.

[0595] In some embodiments, the sleeve 2264 can additionally be configured to hold the first housing member 2202 and the second housing member 2204 in mating engagement with one another (e.g., as shown in FIGS. 22-26). Figure 83A and83B The sleeve 2264 can be the same as or similar to the sleeve 2064 as described above.

[0596] The balloon cover 2200 is shown in an exploded configuration in an exploded view of Figure 77 and is shown in an assembled configuration in various views of Figure 83A and 83B . Figure 82 The first shell member 2202 is shown detached from the rest of the balloon cover 2200. However, since the first shell member 2202 and the second shell member 2204 can be configured to be identical (e.g., identically formed) in some embodiments, the first shell member shown in Figure 82 may instead be the second shell member 2204. Additionally, Figures 78-81B Different views of the recessed sleeve 2240 are shown separately.

[0597] As shown in Figure 77 and 82 ,...

Claims

1. A balloon cover for a delivery device, comprising: A first outer shell member and a second outer shell member are configured to engage with each other, wherein each of the first outer shell member and the second outer shell member includes a first portion and a second portion, the second portion having a wider width than the first portion, the width being defined in a direction perpendicular to the central longitudinal axis of the balloon cover; The first portion of the first housing member and the first portion of the second housing member define a first cavity, the first cavity being configured to receive at least a portion of the distal portion of the delivery device and an inflatable balloon mounted on the distal portion of the delivery device; as well as The second portion of the first housing member and the second portion of the second housing member define a second cavity, the second cavity being configured to receive a positioning device mounted proximally on the distal portion of the delivery device by a valve mounting portion of the distal portion of the delivery device.

2. The balloon covering of claim 1, wherein for each of the first outer shell member and the second outer shell member, the first portion includes an outer surface, an inner surface, and a recess, the recess being recessed toward the outer surface into the inner surface and extending along a length of the first portion defined in a direction parallel to the central longitudinal axis.

3. The balloon cover of claim 2, wherein the inner surface of the first portion of the first outer shell member and the inner surface of the first portion of the second outer shell member are configured to engage with each other, and wherein the recess of the first outer shell member and the recess of the second outer shell member together form the first cavity.

4. The balloon cover of claim 2 or claim 3, wherein the recess comprises a distal segment and a proximal segment, the distal segment being shaped to receive a distal portion of the balloon covering a distal shoulder of the delivery device, and the proximal segment being shaped to receive a middle portion of the balloon covering a valve mounting portion of the delivery device.

5. The balloon covering of claim 4, wherein the proximal segment is narrower than the distal segment.

6. The balloon cover of claim 4 or claim 5, wherein the distal segment is further shaped as part of a nasal cone receiving the delivery device, the nasal cone being disposed at the distal end of the delivery device.

7. The balloon cover according to any one of claims 4-6, further comprising, for each of the first outer shell member and the second outer shell member, a recessed member disposed in the first portion in the region of the distal segment of the recess, the recessed member being configured to form a negative radial recess in the distal portion of the balloon, the recessed member having a wavy inner surface and an outer surface, the outer surface including a first protrusion disposed adjacent to a free end of the recessed member, the free end being configured to be radially inwardly deflected toward the central longitudinal axis relative to the attachment end of the recessed member and the outer surface of the first portion of the first outer shell member or the second outer shell member.

8. The balloon cover of claim 7, wherein the inner surface of the recessed member includes a second protrusion disposed adjacent to the free end, the second protrusion being shaped to form the negative radial recess in the distal portion of the balloon, and further includes a sleeve configured to be positioned around the first portion of the first outer shell member and the first portion of the second outer shell member such that the first outer shell member and the second outer shell member remain engaged with each other, and wherein the free end of each recessed member is configured to move radially inward such that when the sleeve is positioned around the first portion of the first outer shell member and the first portion of the second outer shell member, the first protrusion is aligned with the outer surface of the corresponding first outer shell member or the first portion of the second outer shell member.

9. The balloon covering according to any one of claims 2-6, wherein the first portion of each of the first outer shell member and the second outer shell member includes an elongated recessed member extending axially from an attachment end of the recessed member to a free end along a portion of the first portion, and wherein the free end of the recessed member is configured to deflect radially inward toward the central longitudinal axis in response to radially inward pressure, and to form a negative radial recess in the portion of the balloon surrounded by the recessed member.

10. The balloon cover of claim 9, wherein the recessed member comprises an outer surface and an inner surface, the outer surface having a first protrusion extending radially outward from the outer surface, the inner surface having a second protrusion extending radially inward from the inner surface, the first protrusion and the second protrusion being disposed adjacent to the free end of the recessed member.

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