Commissure markers for prosthetic heart valves

Abstract

Methods and systems for attaching a radiopaque marker to a prosthetic heart valve to indicate a location of a commissure of the prosthetic heart valve are disclosed. As one embodiment, a prosthetic heart valve can include a frame including a plurality of struts forming a plurality of cells of the frame arranged between an inflow end and an outflow end of the frame, a plurality of leaflets arranged within the frame, at least one commissure including an attachment member and commissure tabs of two adjacent leaflets, the attachment member arranged across a selected cell of the plurality of cells of the frame and attached to struts of the frame forming the selected cell, and the commissure tabs of the two adjacent leaflets coupled to the attachment member, and a radiopaque marker arranged on the attachment member of the commissure. The marker is configured to indicate a location of the commissure of the prosthetic heart valve.

Description

[0001] Cross-reference to related applications

[0002] 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

[0003] This disclosure relates to prosthetic heart valves and markings for prosthetic heart valves configured to indicate the location of the commissure portion of the prosthetic heart valve. Background Technology

[0004] The human heart can suffer from various valvular diseases. These diseases can lead to serious heart dysfunction, ultimately requiring repair of the native valve or replacement with an artificial valve. Many known repair devices (e.g., stents) and artificial valves exist, along with numerous known methods for 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 into locations within the body that are not easily accessible through surgery or where access is desired without surgery. In a particular example, a prosthetic heart valve can be mounted in a coiled state on the distal end of the delivery device and advanced through the patient's vascular system (e.g., through the femoral and aortic arteries) until the prosthetic valve reaches its implantation site in the heart. The prosthetic valve is then expanded to its functional size, for example, by inflating a balloon onto which the prosthetic valve is mounted.

[0005] When a prosthetic valve is deployed at the native valve (e.g., via a balloon from an inflatable delivery device), the radially expanded prosthetic valve is deployed with a random radial orientation relative to the native valve. Therefore, in some embodiments, one of the commissures of the prosthetic valve may be positioned anterior to the coronary ostium of the aorta (e.g., adjacent to the coronary ostium of the aorta). This arrangement can reduce coronary access (e.g., blood flow from the aorta to the coronary arteries) and / or create difficulties during future cardiovascular interventions aimed at maintaining or increasing coronary access. Additionally, after implantation of the prosthetic heart valve, it may be desirable to confirm the position of the prosthetic heart valve commissure relative to the commissure of the native heart valve.

[0006] Therefore, there is a need for improved prosthetic heart valve construction that allows identification of the location of one or more commissures of the prosthetic heart valve during the implantation procedure and / or after implantation at the native heart valve. Summary of the Invention

[0007] Embodiments of a prosthetic heart valve including one or more radiopaque markers positioned on or near a commissure of the prosthetic heart valve are described herein. Accordingly, the location of a selected commissure of the prosthetic valve can be identified by medical imaging during a valve implantation procedure and / or after implantation of the prosthetic heart valve at a native heart valve.

[0008] In one representative embodiment, a prosthetic heart valve includes a frame including a plurality of struts forming a plurality of cells of the frame arranged between an inflow end and an outflow end of the frame; a plurality of leaflets arranged within the frame; at least one commissure including an attachment member and commissure tabs of two adjacent leaflets, the attachment member being arranged across a selected cell of the plurality of cells of the frame and attached to struts of the frame forming the selected cell, and the commissure tabs of the two adjacent leaflets being coupled to the attachment member; and a radiopaque marker arranged on the attachment member of the commissure, the marker being configured to indicate a location of the commissure of the prosthetic heart valve.

[0009] In another representative embodiment, a prosthetic heart valve includes a frame including a plurality of struts forming a plurality of cells of the frame arranged between an inflow end and an outflow end of the frame; a plurality of leaflets arranged within the frame; at least one commissure including a first attachment member and commissure tabs of two adjacent leaflets, the first attachment member being arranged across a selected cell of the plurality of cells of the frame and attached to struts of the frame forming the selected cell, and the commissure tabs of the two adjacent leaflets being coupled to the first attachment member; and a radiopaque marker attached to a second attachment member, the second attachment member being arranged across the selected cell and attached to the struts forming the selected cell, the second attachment member being arranged exterior to the first attachment member relative to a central longitudinal axis of the frame. The marker is configured to indicate a location of the commissure of the prosthetic heart valve.

[0010] In another representative embodiment, a prosthetic heart valve includes a frame including a plurality of struts forming a plurality of cells of the frame arranged between an inflow end and an outflow end of the frame; a plurality of leaflets arranged within the frame; at least one commissure including commissure tabs of two adjacent leaflets of the plurality of leaflets connected to one another, the at least one commissure secured to struts of the frame forming a selected cell of the plurality of cells; and a radiopaque marker attached to an attachment member arranged across the selected cell and attached to the struts forming the selected cell. The marker is configured to indicate a location of the commissure of the prosthetic heart valve.

[0011] 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

[0012] Figure 1 is a perspective view of a prosthetic heart valve according to one embodiment.

[0013] Figure 2A is a perspective view of a prosthetic heart valve according to another embodiment.

[0014] Figure 2B is a perspective view of the prosthetic valve of Figure 2A with components on the outside of the frame shown in transparent lines for illustration purposes.

[0015] Figure 3 is a perspective view of a delivery apparatus for a prosthetic heart valve according to one embodiment.

[0016] Figure 4 is a schematic view of an exemplary heart showing the location of a coronary artery relative to an aortic valve.

[0017] Figure 5A illustrates an exemplary positioning of a prosthetic valve in an aortic valve relative to a coronary artery.

[0018] Figure 5B illustrates another exemplary positioning of a prosthetic valve in an aortic valve relative to a coronary artery, wherein the prosthetic valve at least partially inhibits blood flow to the coronary artery.

[0019] Figure 6A is a cross-sectional view of an aortic valve illustrating a first positioning of a prosthetic valve within the aortic valve, wherein a commissure of the prosthetic valve at least partially blocks one or more openings to the coronary artery.

[0020] Figure 6Bis a cross-sectional view of the aortic valve, illustrating a second positioning of the 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.

[0021] Figure 7 illustrates a leaflet cutting procedure, wherein the leaflets of the native aortic valve can be split at the location of the entrance to the coronary arteries when the prosthetic heart valve is implanted within the aortic valve, to enable increased blood flow into the coronary arteries.

[0022] Figure 8A illustrates an exemplary prosthetic heart valve and how splitting the native leaflets of the prosthetic heart valve at the area of the frame of the prosthetic heart valve between two adjacent commissures leads to open cells in front of the entrance to the coronary arteries.

[0023] Figure 8B illustrates Figure 8A an exemplary prosthetic heart valve and how splitting the native leaflets in the area of the frame of the prosthetic heart valve including the commissures does not lead to open cells arranged in front of the entrance to the coronary arteries.

[0024] Figure 9 is a side view of an embodiment of a delivery device configured to deliver a radially expandable prosthetic heart valve and implant it at an implantation site.

[0025] Figure 10 is Figure 9 a cross-sectional side view of a distal end portion of the delivery device of

[0026] Figure 11 is Figure 9 a side view of a distal tip portion of the outer shaft of the delivery device of

[0027] Figure 12 is Figure 9 a schematic view of an embodiment of the intermediate shaft of the delivery device of

[0028] Figure 13 is Figure 11 a cross-sectional side view of a detail portion of the coaxial shaft of the delivery device of

[0029] Figure 14 is Figure 9 a cross-sectional side view of a handle of the delivery device of

[0030] Figure 15 is a first perspective view of an embodiment of a rotatable knob mounted on a proximal end portion of the intermediate shaft of the delivery device, the knob being configured to rotate the intermediate shaft, thereby rotating the inflatable balloon and the prosthetic heart valve radially compressed onto the balloon.

[0031] Figure 16 is Figure 15 a second perspective view of the knob of

[0032] Figure 17 is Figure 15 a cross-sectional side view of the knob of

[0033] Figure 18 is Figure 15 a cross-sectional view of an anchor of the knob of

[0034] Figure 19 is Figure 18 a perspective view of the anchor of

[0035] Figure 20 is Figure 15 an exploded view of an outer housing of the knob of

[0036] Figure 21 is a side view of the anchor of Figure 18 mounted on a proximal portion of an intermediate shaft.

[0037] Figure 22 is a side view of the knob of Figure 15 mounted on a proximal portion of an intermediate shaft, with one housing portion of the outer housing removed to show the anchor.

[0038] Figure 23 is a perspective view of an embodiment of a proximal portion of a delivery apparatus, the delivery apparatus including a handle, a rotatable knob, and an adapter.

[0039] Figure 24 is Figure 23 a perspective view of the adapter in

[0040] Figure 25 is Figure 24 a cross-sectional view of the adapter of

[0041] Figure 26 is a cross-sectional view of the adapter of Figure 24 mounted on a proximal portion of a delivery apparatus.

[0042] Figure 27 is a detailed cross-sectional view of a portion of the adapter of Figure 26 including a rotational interface between the second port and the body of the adapter.

[0043] Figure 28illustrates a side view of a distal portion of a delivery device with an example radio-opaque marker positioned on and / or embedded within a polymer body of the distal portion of the delivery device.

[0044] Figure 29 illustrates Figure 28 an example fluoroscopic image of a distal portion of a delivery device including a radio-opaque marker.

[0045] Figure 30 illustrates an embodiment of an asymmetric radio-opaque marker that allows a user to distinguish two different locations of the marker within an imaging view.

[0046] Figure 31A is an example fluoroscopic image illustrating a guidewire extending through a distal portion of a delivery device and an asymmetric marker of Figure 30 arranged on or embedded within a portion of the distal portion of the delivery device and in a first orientation relative to the guidewire.

[0047] Figure 31B is an example fluoroscopic image illustrating a guidewire extending through a distal portion of a delivery device and an asymmetric marker of Figure 30 arranged on or embedded within a portion of the distal portion of the delivery device and in a second orientation relative to the guidewire.

[0048] Figure 32A is a side view of an example delivery device with Figure 30 an asymmetric marker of arranged on or embedded within a distal shoulder of the delivery device.

[0049] Figure 32B is a perspective view of an example delivery device of Figure 32A with Figure 30 an asymmetric marker of arranged on or embedded within a distal shoulder of the delivery device.

[0050] Figure 33 illustrates another embodiment of an asymmetric radio-opaque marker that allows a user to distinguish two different locations of the marker within an imaging view.

[0051] Figure 34A is an example fluoroscopic image illustrating a guidewire extending through a distal portion of a delivery device and an asymmetric marker of Figure 33 arranged on or embedded within a portion of the distal portion of the delivery device and in a first orientation relative to the guidewire.

[0052] Figure 34Bis an example fluoroscopy image illustrating a guidewire extending through a distal portion of a delivery apparatus and a marker arranged on or embedded within a portion of the distal portion of the delivery apparatus and in a second orientation relative to the guidewire Figure 33 asymmetrical markers.

[0053] Figure 35A illustrates an example embodiment of radio-opaque markers attached to commissures of a prosthetic valve in a radially compressed configuration.

[0054] Figure 35B illustrates a prosthetic valve of Figure 35A in a radially expanded configuration.

[0055] Figure 35C illustrates an example prosthetic heart valve having first attachment members arranged across cells of the prosthetic heart valve and secured to struts forming the cells and radio-opaque markers secured to second attachment members configured to be attached to the struts forming the cells, wherein commissure tabs of adjacent leaflets of the prosthetic heart valve are secured to the first attachment members to form commissures.

[0056] Figure 35D-35F illustrates first and second attachment members attached to struts forming cells with the same suture.

[0057] Figure 35G illustrates a marker of Figure 35C attached to a second attachment member in front of a first attachment member of a commissure, the second attachment member being attached to struts forming cells of a prosthetic valve.

[0058] Figure 35H illustrates an inner surface of a commissure and first attachment members attached to cells of a prosthetic valve.

[0059] Figure 35I illustrates an example radio-opaque marker configured to be attached to a commissure within a cell of a prosthetic valve.

[0060] Figure 35J illustrates another example embodiment of a radio-opaque marker attached to a commissure within a cell of a prosthetic valve.

[0061] Figure 35K illustrates another example embodiment of a radio-opaque marker attached to a commissure within a cell of a prosthetic valve.

[0062] Figure 35LAnother example embodiment of radio-opaque markers attached to the commissures within the cells of a prosthetic valve and radio-opaque markers attached to the skirt that extends just below the commissures through the inner surface of the frame of the prosthetic valve.

[0063] Figure 35M Another example embodiment of radio-opaque markers attached to the commissures within the cells of a prosthetic valve and radio-opaque markers attached to the skirt that extends just below the commissures through the inner surface of the frame of the prosthetic valve.

[0064] Figure 35N Another example embodiment of radio-opaque markers attached to the commissures within the cells of a prosthetic valve and radio-opaque markers attached to the skirt that extends just below the commissures through the inner surface of the frame of the prosthetic valve.

[0065] Figure 35O Another example embodiment of radio-opaque markers attached to the commissures within the cells of a prosthetic valve and radio-opaque markers attached to the skirt that extends just below the commissures through the inner surface of the frame of the prosthetic valve.

[0066] Figure 35P Another example embodiment of radio-opaque markers attached to the commissures within the cells of a prosthetic valve and radio-opaque markers attached to the skirt that extends just below the commissures through the inner surface of the frame of the prosthetic valve.

[0067] Figure 36 An embodiment of an inflatable balloon folded around a distal end portion of a delivery apparatus.

[0068] Figure 37 is a cross-sectional view of an inflatable balloon wrapped and folded around a portion of a delivery apparatus at a valve mounting portion of the delivery apparatus according to an embodiment.

[0069] Figure 38 is a perspective view of an embodiment of a distal tip portion of an outer shaft for a delivery apparatus, the distal tip portion including a plurality of helical internal expansion grooves.

[0070] Figure 39 is a cross-sectional view of a distal tip portion of Figure 38 .

[0071] Figure 40 is a side view of a distal end portion of a delivery apparatus, illustrating a radial indentation in the distal end portion of the inflatable balloon of the delivery apparatus when the distal tip portion is disposed away from the proximal end portion of the balloon.

[0072] Figure 41 is a side view of a distal end portion of a delivery apparatus of Figure 40 , illustrating a condition of the distal end portion of the inflatable balloon when the distal tip portion is disposed over the proximal end portion of the balloon and a prosthetic valve is mounted on a valve mounting portion of the delivery apparatus.

[0073] Figure 42 is a side view of a distal portion of an exemplary delivery apparatus with a prosthetic valve mounted on and around a valve mounting portion of the distal portion of the delivery apparatus in a radially compressed state, with selected commissures of the prosthetic valve being circumferentially offset from radiopaque markers on the delivery apparatus by a predetermined amount.

[0074] Figure 43 is a rear perspective view of an exemplary embodiment of a crimping device configured to crimp a prosthetic valve onto a portion of a delivery apparatus.

[0075] Figure 44 is a front perspective view of the crimping device of Figure 43 .

[0076] Figure 45 is 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 apparatus in a predetermined position and / or orientation relative to the delivery apparatus, the support body being configured to hold the prosthetic valve in a radially expanded state.

[0077] Figure 46 is a front perspective view of an embodiment of a ring body configured to be coupled to Figure 45 the support body of and to circumferentially align the prosthetic valve on the support body in a desired orientation.

[0078] Figure 47 Figure 46 is a rear perspective view of the ring body of .

[0079] Figure 48 is a perspective view of the ring body of Figure 45 coupled to the support body of Figure 46 .

[0080] Figure 49 is a perspective view of an embodiment of a positioning device of a mounting assembly coupled to a distal portion of a delivery apparatus.

[0081] Figure 50 is an end view of a prosthetic valve mounted on Figure 45 the support body of Figure 46 , with commissures aligned with corresponding indicators on the ring body of .

[0082] Figure 51 is a cross-sectional view of a mounting assembly comprising Figure 45 the support body of Figure 49 and Figure 43 the positioning device of coupled to and disposed within the crimping device of such that the prosthetic valve is disposed around a valve mounting portion of a distal portion of the delivery apparatus in a predetermined orientation and / or position relative to the delivery apparatus.

[0083] Figure 52 is a cross-sectional view of a prosthetic valve radially compressed onto a valve mounting portion of a delivery apparatus after a crimping operation performed with a crimping device. Figure 43

[0084] Figure 53 is a perspective view of another embodiment of a positioning device that can be used in an installation assembly and coupled to a crimping device.

[0085] Figure 54 is a side view of a positioning device of Figure 53 coupled to a distal end portion of a delivery apparatus proximally of a valve mounting portion.

[0086] Figure 55 is a perspective view of a positioning device of Figure 54 coupled to a distal end portion of a delivery apparatus of Figure 53

[0087] Figure 56 is a flowchart of an exemplary method for crimping a prosthetic valve into a radially compressed state onto a distal end portion of a delivery apparatus in a predetermined position and a predetermined orientation relative to the delivery apparatus.

[0088] Figure 57 is a flowchart of an exemplary method for implanting a prosthetic valve at a native valve of a patient if one or more selected commissures of the prosthetic valve are aligned with one or more corresponding commissures of the native valve.

[0089] Figure 58 illustrates an exemplary fluoroscopic image of a native valve viewed with a standard tricuspid imaging view.

[0090] Figure 59 illustrates an exemplary fluoroscopic image of a distal end portion of a delivery apparatus including asymmetric non-radio-opaque markers that are centered along a guide wire extending through the delivery apparatus and appear in a forwardly readable orientation, thereby indicating that the markers are directly behind the imaging view.

[0091] Figure 60 is a schematic diagram illustrating a desired rotational positioning of a distal end portion of a delivery apparatus including a prosthetic valve mounted thereon at a native valve, wherein asymmetric non-radio-opaque markers of the delivery apparatus are aligned with a target commissure of the native valve and selected commissures of the prosthetic valve are circumferentially offset from the markers by a predetermined amount.

[0092] Figure 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 apparatus in a patient's heart and rotationally align a prosthetic valve mounted on the delivery apparatus during an implantation procedure.

[0093] ​​ Figure 62 is a cross-sectional view of a native valve, illustrating Figure 61 the location of the commissure of the native valve within the imaging view of

[0094] Figure 63 is a schematic view 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 during an implant procedure and rotationally align a prosthetic valve mounted on the delivery device.

[0095] Figure 64 is a cross-sectional view of a native valve, illustrating Figure 63 the location of the commissure of the native valve within the imaging view of

[0096] Figure 65 illustrates an embodiment of an alignment ring configured to rotationally align a prosthetic valve relative to a delivery device for an implant procedure using a first imaging view.

[0097] Figure 66 illustrates another embodiment of an alignment ring configured to rotationally align a prosthetic valve relative to a delivery device for an implant procedure using a second imaging view.

[0098] Figure 67 illustrates another embodiment of an alignment ring including multiple sets of alignment markers for use in two or more implant procedures utilizing different selected imaging views.

[0099] Figure 68 illustrates another embodiment of an alignment ring including one or more sets of graduated alignment markers.

[0100] Figure 69 is an exploded view of an embodiment of a balloon cover for a distal end portion of a delivery device, the balloon cover configured to cover an inflatable balloon and a positioning device mounted on the distal end portion.

[0101] Figure 70 is a perspective view of a shell member of the balloon cover of Figure 60 configured to matingly engage with another shell member of the balloon cover to form an outer shell of the balloon cover.

[0102] Figure 71A is a detailed view of a portion of a mating edge of the shell member of Figure 70 including an elongated protrusion.

[0103] Figure 71B is a detailed view of another portion of the mating edge of the shell member of Figure 70 including an elongated recess.

[0104] Figure 71Cis a detailed view of a portion of the mating interface between the two outer shell members of the balloon cover of Figure 60

[0105] Figure 72 is a first side view of the balloon cover of Figure 69

[0106] Figure 73 is a second side view of the balloon cover of Figure 69 Figure 72

[0107] Figure 74 is a perspective end view of the balloon cover of Figure 69

[0108] Figure 75A is a perspective view of the balloon cover of Figure 69

[0109] Figure 75B is an end view of the balloon cover of Figure 75A

[0110] Figure 75C is a cross-sectional end view of the balloon cover of Figure 75A

[0111] Figure 76A is a perspective view of another embodiment of a balloon cover for a distal end portion of a delivery device, the balloon cover configured to cover an inflatable balloon and a positioning device mounted on the distal end portion, wherein a portion of the balloon cover covering the positioning device has a wall that completely encloses the positioning device therein.

[0112] Figure 76B is an end view of the balloon cover of Figure 76A

[0113] Figure 77 is an exploded view of another embodiment of a balloon cover for a distal end portion of a delivery device, the balloon cover configured to cover an inflatable balloon and a positioning device mounted on the distal end portion, and to produce a specified final shape of the inflatable balloon.

[0114] Figure 78 is an end view of the balloon cover of Figure 77 ​​​​​​​​​is a perspective view of a recessed sleeve of a balloon cover including one or more recessed members.

[0115] Figure 79 is Figure 78 is an end view of the recessed sleeve of

[0116] Figure 80 is Figure 78 is another perspective view of the recessed sleeve of

[0117] Figure 81A is a cross-sectional side view of the recessed sleeve of Figure 78

[0118] Figure 81B is a cross-sectional side view of the recessed sleeve of Figure 78

[0119] Figure 82 is a perspective view of a shell member of a balloon cover of Figure 77

[0120] is a first cross-sectional side view of an assembled balloon cover of Figure 83A Figure 77

[0121] Figure 83B is a second cross-sectional side view of an assembled balloon cover of Figure 77

[0122] Figure 84 is a plan view of another exemplary embodiment of a shell member for a balloon cover configured to receive a portion of a distal end portion of a delivery device including an inflatable balloon and a positioning device mounted thereon and form a designated final shape of the balloon around the delivery device.

[0123] Figure 85 is a perspective view of the shell member of Figure 84

[0124] is a cross-sectional side view of the shell member of Figure 86 Figure 84 is a perspective view of a shaft connector release assembly coupling a proximal end portion of a rotatable shaft of a delivery device to an adapter.

[0125] Figure 87A is a cross-sectional view of the shaft connector release assembly of

[0126] Figure 87B Figure 87A

[0127] Figure 88 ​​​​​​​​yes Figure 87A Exploded view of the shaft connector release assembly, the proximal portion of the rotatable shaft, and the adapter.

[0128] Figure 89 It is a separate part of the assembly structure. Figure 87A A perspective view of the shaft connector release assembly.

[0129] Figure 90 yes Figure 89 Exploded view of the shaft connector release assembly.

[0130] Figure 91 yes Figure 89 A perspective view of an embodiment of the release sleeve of the shaft connector release sleeve.

[0131] Figure 92 yes Figure 91 Side view of the release sleeve.

[0132] Figure 93 yes Figure 92 A cross-sectional side view of the release sleeve.

[0133] Figure 94 yes Figure 89 A perspective view of an embodiment of the adapter insert for the shaft connector release assembly.

[0134] Figure 95 yes Figure 94 Side view of the adapter insert.

[0135] Figure 96 yes Figure 95 A cross-sectional side view of the adapter insert.

[0136] Figure 97 An exemplary radiopaque marker is shown sutured to the central portion of an attachment member configured to form a junction with the junction lug of an adjacent leaflet of a prosthetic heart valve, and configured to be arranged across the unit of the prosthetic heart valve and secured to a strut forming the unit.

[0137] Figure 98A It shows the fixation to Figure 97 Markings on the outer surface of the attachment member and lugs for fixing to the inner surface of the attachment member.

[0138] Figure 98B The support pillars attached to the unit are shown. Figure 98A The markings on the attachment components and the parts that are away from the joint.

[0139] Figure 99A It shows the fixation to Figure 97 Markings on the inner surface of the attachment member and lugs for fixing to the inner surface of the attachment member.

[0140] Figure 99B An exemplary embodiment of a marker positioned against an elongated tab of an attachment member configured to form a commissure with a commissure tab of an adjacent leaflet of a prosthetic heart valve and configured to be disposed across and secured to struts forming a cell of the prosthetic heart valve is shown. Figure 99B An attachment member of and a marker facing a commissure of

[0141] Figure 100 An exemplary embodiment of a marker positioned against an elongated tab of an attachment member configured to form a commissure with a commissure tab of an adjacent leaflet of a prosthetic heart valve and configured to be disposed across and secured to struts forming a cell of the prosthetic heart valve is shown.

[0142] Figure 101A-101E A process of suturing a marker to an attachment member of Figure 100 using one or more fasteners for securing a commissure tab of a leaflet to the attachment member is shown.

[0143] Figure 102 is a perspective view of another embodiment of a rotatable knob mounted on a proximal end 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.

[0144] Figure 103 is a side view of the knob of Figure 102 .

[0145] Figure 104 is a first exploded view of the knob of Figure 102 , showing two housing portions of the knob that enclose an anchor and an adapter therein.

[0146] Figure 105 is a second exploded view of the knob of Figure 102 .

[0147] Figure 106 is a first cross-sectional side view of the knob of Figure 102 , showing the anchor and the adapter inside the housing of the knob.

[0148] Figure 107 is a second cross-sectional side view of the knob of Figure 102 , showing alignment tabs of the anchor and the adapter inside the housing of the knob.

[0149] Figure 108 is a perspective view of another embodiment of a balloon cover for a distal end portion of a delivery apparatus, the balloon cover configured to cover an inflatable balloon and a positioning device mounted on the distal end portion.

[0150] Figure 109 is a side view of the balloon cover of Figure 108 .

[0151] Figure 110is a partial cross-sectional side view of the balloon cover of Figure 108

[0152] Figure 111 is another side view of the balloon cover of Figure 108

[0153] Figure 112 is another side view of the balloon cover of Figure 111

[0154] Figure 113 is a cross-sectional perspective view of the balloon cover of Figure 108

[0155] Figure 114 is a partial cross-sectional side view of the balloon cover of Figure 108 DETAILED DESCRIPTION

[0156] It is contemplated in general

[0157] 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 aspects and features, nor do the methods, systems, and devices require that any one or more specific advantages be present or problems be solved.

[0158] 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 of the features disclosed in this specification (including any accompanying claims, abstract, and drawings) can be combined in any combination, except combinations that would be incompatible with the subject matter of this disclosure. The disclosure is not to be limited to the details outlined in any of the foregoing embodiments. The disclosure extends to any novel one, or any novel combination, of the features disclosed in this specification (including any accompanying claims, abstract, and drawings), or to any novel one, or any novel combination, of the steps of any method or process so disclosed.

[0159] ​​​​​Although the operations of some of the methods disclosed herein are described in a particular, sequential order for convenient presentation, it should be understood that this manner of description encompasses rearrangement of otherwise illustrated operations without departing from the scope of the underlying conceptual arrangements. 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 or practiced with other systems, methods, and devices.

[0160] 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 "a" or "at least one" of the elements is also present. The terms "plurality" and "multiple" refer to two or more of the specified elements.

[0161] 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."

[0162] 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.

[0163] Directions and other relative references (e.g., inner, outer, upper, lower, etc.) can be used to facilitate 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, particularly with respect to the illustrated embodiments. However, such terms are not intended to imply absolute relationships, orientations, 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."

[0164] 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 the longitudinal axis of a prosthetic valve).

[0165] Examples of the disclosed technology

[0166] Examples of prosthetic valve delivery apparatus 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.

[0167] Examples of balloon coverings configured to receive a distal portion of a delivery apparatus 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 portion of the delivery apparatus.

[0168] Assemblies for coupling a rotatable shaft of a delivery apparatus to an adapter of the delivery apparatus that is configured to receive inflation fluid for an inflatable balloon of the delivery apparatus are also described herein.

[0169] 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 that extends 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.

[0170] In this manner, the delivery apparatus can be configured to rotationally align the radially compressed prosthetic valve at the native valve such that the prosthetic valve is implanted with the commissures of the prosthetic valve aligned (e.g., circumferentially aligned) with the 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 a marker on the shoulder of the delivery apparatus or the alternative polymeric body is aligned with a desired landmark of the native anatomy and / or the guidewire within a selected imaging view.

[0171] The prosthetic valves disclosed herein can be radially compressed and expanded between a radially compressed configuration and a radially expanded configuration. Thus, the prosthetic valve can be crimped in the radially compressed configuration on a delivery apparatus during delivery and then expanded to the radially expanded configuration once the prosthetic valve reaches the implantation site. In some embodiments, the prosthetic valve can be deployed from the delivery apparatus at the implantation site (e.g., a native valve of a heart) via inflation of an inflatable balloon of the delivery apparatus.

[0172] Figure 1 A prosthetic heart valve (e.g., 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, a middle portion 17, and an outflow end portion 19.

[0173] 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), biocompatible synthetic materials, 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 by reference herein.

[0174] The frame 12, or components thereof (e.g., struts and / or fasteners), can be made from any of a variety of suitable plastically expandable materials (e.g., stainless steel, etc.) or self-expandable materials (e.g., nickel-titanium (NiTi), such as Nitinol) as known in the art. When made 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 made from a self-expandable 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.

[0175] 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 made from a nickel-cobalt-chrome-molybdenum alloy, such as MP35N® alloy (SPS Technologies, Jenkintown, Pennsylvania), which is equivalent to UNS R30035 alloy (covered by ASTM F562-02). By weight, The MP35N® alloy / 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 by reference herein. The MP35N® alloy / 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 by reference herein.

[0176] Figure 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. Figure 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.

[0177] As with the prosthetic valve 10, the prosthetic valve 50 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 made from a self-expandable material, the frame 52 (and thus the prosthetic valve 50) 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. Figure 1The valve-like structure 14, valve-like structure 54 may include three leaflets 60 that together form a leaflet structure, which may be arranged to collapse in a tricuspid arrangement. Each leaflet 60 may be coupled to the frame 52 along its inflow edge 62 (lower edge in the figure, also referred to as the "tip edge") and at the fusion portion 64 of the valve structure 54 where adjacent portions of two leaflets connect to each other (e.g., fusion lugs). In some embodiments, the fusion portion 64 may include an attachment member (e.g., including fabric, flexible polymer, etc.) arranged across units (e.g., fusion units) of the frame 52, the unit being formed by the struts of the frame. The attachment member may be secured to the struts of the frame forming the unit, and adjacent portions of two leaflets may be connected to the attachment member to form the fusion portion 64 (e.g., as shown in the figure). Figure 16 and 17 As shown, as further described below).

[0178] Reinforcing elements (not shown) (such as fabric strips) can be directly attached to the tip edge of the leaflet and the struts of the frame to couple the tip edge of the leaflet to the frame.

[0179] Similar to Figure 1 The frame 12 and frame 52 can be made of any of the various suitable malleable or self-expanding materials known in the art and described above. In the illustrated embodiment, frame 52 includes a plurality of circumferentially extending, inclined struts 72 defining the row units or openings 74 of the frame. Frame 52 can have a cylindrical or substantially cylindrical shape having a constant diameter from the inlet end 66 to the outlet 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 herein by reference.

[0180] The frame 52 may include a plurality of vertices 80 spaced apart from each other around the circumference of the frame 52 at each of the inlet end 66 and the outlet end 68.

[0181] In the illustrated embodiment, the sealing member 56 is mounted on the outer side of the frame 52 and is used to form a seal against surrounding tissue (e.g., native leaflets and / or native valve annulus) to prevent or at least minimize paravalvular leakage. The sealing member 56 may include an inner layer 76 (which may contact the outer surface of the frame 52) and an outer layer 78. The sealing member 56 may be attached to the frame 52 using suitable techniques or mechanisms. For example, the sealing member 56 may be sutured to the frame 52 via sutures that may extend around the strut 72 and through the inner layer 76. In an alternative embodiment, the inner layer 76 may be mounted on the inner surface of the frame 52, while the outer layer 78 is on the outer side of the frame 52.

[0182] 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 the surrounding tissue when implanted inside the body.

[0183] 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.

[0184] Figure 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.

[0185] In Figure 3 In the illustrated embodiment of 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., 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 FIGS. 2-4. 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 the vasculature of a patient. In some embodiments, the balloon shoulder assembly can include a proximal shoulder 120 and / or a distal shoulder 122. Figure 9-11

[0186] 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 the distal end of the outer shaft 104. Rotating the knob 134 effectively increases or decreases the tension in the pull wire, thereby adjusting the curvature of the distal end portion of the delivery device.

[0187] ​In some embodiments, the delivery device (or another similar delivery device) can be configured to deploy and implant a prosthetic heart valve (e.g., Figure 1 the prosthetic valve 10 of Figure 2A and 2B the prosthetic heart valve 50 of Figure 4 In some embodiments, the delivery device can be configured to deploy and implant the prosthetic heart valve in a native aortic annulus of a native aortic valve. In some embodiments, the delivery device can be configured to deploy and implant the prosthetic heart valve in a native mitral annulus of a native mitral valve. Figure 4 As shown in

[0188] As shown in Figure 5A Because the prosthetic heart valve 206 is implanted in the native aortic annulus of the aortic valve 202, blood flow 208 can exit the prosthetic heart valve 206, flow into the aorta 205, and then flow past 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 Figure 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 Figure 5B When the commissure 210 of the prosthetic heart valve 206 is disposed in front of (e.g., adjacent to) the opening to one of the coronary arteries 204, the interference with blood flow to the coronary arteries 204 can be further exacerbated Figure 5B . For example, because the adjacent leaflets are coupled together at the commissure 210, the commissure 210 blocks and / or reduces blood flow through the cells to which they are coupled. Thus, less oxygenated blood flow can reach the coronary arteries and the heart muscle.

[0189] Accordingly, rather than deploying the prosthetic heart valve with a random rotational orientation relative to the aorta 205, which can result in the commissure 210 of the prosthetic heart valve 206 being disposed in front of the coronary arteries 204 (as shown in Figure 6A , it can be desirable to deploy the prosthetic heart valve 206 in a target rotational orientation in which the commissure 210 is positioned away from the coronary arteries 204 and does not block the coronary arteries 204 (as shown in Figure 6B . For example, as shown in Figure 6B the delivery device can be configured to deploy the prosthetic heart valve 206 such that the commissure 210 of the radially expanded prosthetic heart valve 206 is circumferentially aligned with the native commissure 212 of the aortic valve 202.

[0190] As further explained 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 Figure 6B The example shows alignment of the suture portion, thereby increasing blood flow into coronary artery 204. Additionally, this positioning of the prosthetic heart valve facilitates a later leaflet cutting procedure that provides increased blood flow to the coronary arteries, such as... Figure 7-8B As shown.

[0191] For example, such as Figure 7 As 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.

[0192] like Figure 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. Figure 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... Figure 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.

[0193] 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.

[0194] Figure 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.

[0195] Figure 9-14 The illustration depicts a retractable prosthetic heart valve (e.g., according to an embodiment) that can be used for implantation. Figure 1 10 or more prosthetic valves Figure 2A-2Bprosthetic valve 50) or another type of expandable prosthetic medical device, such as a stent. In some embodiments, the delivery device 300 is particularly suitable for use in introducing a prosthetic valve into a heart. As described further below, the delivery device 300 can be configured to rotate at a target implant site (e.g., at a native valve of a heart) to install a prosthetic valve in a radially compressed state on the delivery device to enable commissure alignment between the native valve and the prosthetic valve after deployment of the prosthetic valve.

[0196] Similar to the delivery device 100 of Figure 3 , the delivery device 300 is a balloon catheter that includes a handle 302 and a steerable outer shaft 304 extending distally from the handle 302 Figure 9 and 14 . The delivery device 300 can further include an intermediate shaft 306 (which can also be referred to as a balloon shaft) extending proximally from the handle 302 Figure 9 and 14 and distally from the handle 302, the portion extending distally from the handle 302 also extending coaxially through the outer shaft 304. Additionally, the delivery device 300 can further include an inner shaft 308 extending distally from the handle 302, coaxially through the intermediate shaft 306 and the outer shaft 304 (as shown in detail portion 355 in Figure 13 ), and extending proximally from the handle 302, coaxially through the intermediate shaft 306.

[0197] As described further below, the outer shaft 304 and the 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.

[0198] The intermediate shaft 306 can include a proximal end portion 310 extending proximally from a proximal end of the handle 302 to a proximal end of the adapter 312 Figure 9 and 14 . A rotatable knob 314 can be mounted on the proximal end portion 310 Figure 9 and 14 and can be configured to rotate the intermediate shaft 306 about the central longitudinal axis 320 of the delivery device 300 and relative to the outer shaft 304, as described further below with reference to Figure 15-22 .

[0199] The 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., an inflation fluid) from a fluid source. The second port 340 can be fluidly coupled to an inner lumen of the intermediate shaft 306, as described further below.

[0200] The intermediate shaft 306 can further include a distal end portion 316 that distally extends beyond a distal end of the outer shaft 304 (e.g., as described below with reference to Figure 10 and 11 ) when the distal end of the outer shaft 304 is positioned away from an inflatable balloon 318 of the delivery apparatus (e.g., as described further below with reference to Figure 38-41 ). A distal end portion of the inner shaft 308 can distally extend beyond the distal end portion 316 of the intermediate shaft 306 ( Figure 10 ).

[0201] The balloon 318 is coupled to the distal end portion 316 of the intermediate shaft 306. For example, in some embodiments, a proximal end portion of the balloon 318 is coupled to and / or around a distal end 348 of the intermediate shaft 306 ( Figure 10 and 11 ).

[0202] The balloon 318 can include a distal end portion (or segment) 332, a proximal end portion (or segment) 333, and an intermediate portion (or segment) 335 disposed between the distal end portion 332 and the proximal end portion 333.

[0203] In some embodiments, a distal end of the distal end portion 332 of the balloon 318 can be coupled to a distal end of the delivery apparatus 300, such as to a nosecone 322 (as shown in Figure 9-11 ), or to an alternative component (e.g., a distal shoulder) at the distal end of the delivery apparatus 300. In some embodiments, the intermediate portion 335 of the balloon 318 can cover a valve mounting portion 324 of the distal end portion 309 of the delivery apparatus 300, the distal end portion 332 can cover a distal shoulder 326 of the delivery apparatus 300, and the proximal end portion 333 can surround a portion of the inner shaft 308 ( Figure 10 ). The valve mounting portion 324 and the intermediate portion 335 of the balloon 318 can be configured to receive a prosthetic heart valve in a radially compressed state (e.g., as shown in Figure 41 and 42 , as described further below).

[0204] As described further below, rotation of the intermediate shaft 306 causes rotation of the balloon 318 and a prosthetic valve mounted thereon so as to rotationally position the prosthetic valve relative to native anatomy at a target implant site.

[0205] The balloon shoulder assembly is configured to maintain a prosthetic heart valve or other medical device at a fixed position on the balloon 318 during delivery through a patient’s vasculature. The balloon shoulder assembly can include a distal shoulder 326 disposed within a distal end portion of the balloon 318 and coupled to a distal end portion of the inner shaft 308 ( Figure 9-11The 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).

[0206] For example, in some embodiments, the distal shoulder 326 may include a flared portion 331 arranged adjacent to the valve mounting portion 324. Figure 10 In some embodiments, the flared portion 331 may include a portion extending from the distal shoulder 326. Figure 10 The 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). Figure 28 , 32A -32B and 40-42 are discussed in more detail.

[0207] The outer shaft 304 may include a distal tip portion 328 mounted on its distal end. Figure 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. Figure 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). Figure 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.

[0208] 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.

[0209] 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. Figure 10 and 11 And also Figure 32A and 40 (as shown in the image).

[0210] like Figure 10As 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. Figure 40 and 41 The radial recess 334 is described in further detail.

[0211] like Figure 13 Selected portion 355 of delivery device 300 (from Figure 11 As 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. Figure 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.

[0212] Inner shaft 308 ( Figure 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. Figure 29 , 31A Exemplary guidewires are shown in -31B, 34A-34B and 59, as further described below.

[0213] like Figure 12 A schematic diagram of the intermediate shaft 306 and Figure 13 Selected portion 355 of delivery device 300 in Figure 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).

[0214] 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. Figure 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.

[0215] 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). Figure 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. Figure 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.

[0216] 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.

[0217] 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.

[0218] Handle 302 can further include an adjustment mechanism 361 including an adjustment member, such as the illustrated rotatable knob 362, and a shaft 364 extending distally into a housing 366 of handle 302. Adjustment mechanism 361 is configured to adjust the axial position of intermediate shaft 306 relative to outer shaft 304 FIG. 9 and 14 ). In some embodiments, as illustrated in FIG. 14 , an inner support 368 is mounted within housing 366 on intermediate shaft 306, and an inner shaft 370 (also referred to as a slider or sliding mechanism) is mounted on inner support 368. Inner shaft 370 has a distal portion 372 formed with external threads that mate with internal threads extending along an inner surface of shaft 364. Inner shaft 370 further includes a proximal portion 374 that mounts and interfaces with a locking mechanism 376 configured to hold (e.g., lock) the position of intermediate shaft 306 relative to handle 302. Inner shaft 370 can be coupled to inner support 368 such that rotation of shaft 364 causes inner shaft 370 to move axially within handle 302. Locking mechanism 376 can include another adjustment member, a rotatable knob 378 configured to receive an inner nut 380 having internal threads that engage the external threads of proximal portion 374 of inner shaft 370.

[0219] To limit movement of intermediate shaft 306 for precise positioning of a prosthetic valve mounted on a distal end portion of delivery device 300, rotatable knob 378, which in turn causes rotation of inner nut 380. Inner nut 380 thus translates in a distal direction along the external threads on proximal portion 374 of inner shaft 370. When nut 380 moves distally, additional components of locking mechanism 376 are configured to frictionally engage intermediate shaft 306, thereby holding intermediate shaft 306 relative to inner shaft 370. In the locked position, rotation of knob 362 causes axial movement of inner shaft 370 and intermediate shaft 306 relative to outer shaft 304 (in either the proximal or distal direction, depending on the direction in which knob 362 is rotated).

[0220] Rotation of knob 378 in the opposite direction from the locked position to the unlocked position allows for axial and rotational movement of intermediate shaft relative to inner shaft 370 and the proximal end portion of handle 302. Further details regarding adjustment mechanism 361 and locking mechanism 376 of handle 302 can be found in U.S. Patent No. 9,339,384, which is incorporated by reference herein.

[0221] 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. Thus, rotating the knob 314 can cause the prosthetic valve to rotate about the central longitudinal axis 320 to a desired orientation relative to the native anatomy at the target implant site.

[0222] FIGS. 15-22 Various views of an embodiment of the knob 314 are shown, which is configured to cause the intermediate shaft 306 to rotate upon rotation of the knob 314. In alternative embodiments, a differently configured rotatable knob or other adjustment mechanism can be used in place of the knob 314 in order to rotate the intermediate shaft 306 of the delivery apparatus 300.

[0223] As FIG. 15 and 16 (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. Thus, rotating the knob 314 can cause the prosthetic valve to rotate about the central longitudinal axis 320 to a desired orientation relative to the native anatomy at the target implant site. FIG. 9 and 14 ) perspective views, the knob 314 can be mounted on the proximal end portion 310 of the intermediate shaft 306 distally of the adapter 312. In some embodiments, the knob 314 can be directly coupled to and / or disposed about a portion or the entirety of the adapter 312 (e.g., as shown in FIGS. 102-107 , described further below). In alternative embodiments, the knob 314 can be axially spaced apart from the adapter 312.

[0224] The knob 314 can include an outer housing 382 FIGS. 15-17 and 20) disposed about (e.g., housing) one or more internal components of the knob 314. In some embodiments, the outer housing 382 can include one or more gripping elements 383 configured to increase traction or grip for a user to rotate the knob 314. In some embodiments, the one or more gripping elements 383 can be raised elements or features that extend outwardly from an outer surface of the outer housing 382 and are spaced apart from one another about a circumference of the outer housing 382. In alternative embodiments, the one or more gripping elements 383 can be raised ridges and / or recessed notches in the outer housing 382.

[0225] In some embodiments, in order to increase ease of assembly of the knob 314, the outer housing 382 can be split into two or more mating components. For example, in some embodiments, as shown in FIG. 15 , 16As 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.

[0226] 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.

[0227] 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.

[0228] 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.

[0229] 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. 15-17The 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).

[0230] 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 ).

[0231] like FIGS. 17-19 As 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.

[0232] 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.

[0233] 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.

[0234] 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 and18 The countersunk hole 398 enables enhanced UV bonding between the anchor 386 and the intermediate shaft 306.

[0235] 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. 33 The marking 650 shown is aligned. In some embodiments, such as FIG. 21 and 22 As shown, the alignment lug 399 can extend radially outward from the anchor 386. In some embodiments, the alignment lug 399 can extend radially outward from the axial portion 387 of the anchor 386 in a direction perpendicular to the direction in which the extension portion 394 extends radially outward from the axial portion 387 of the anchor 386. As further described below, during assembly, the alignment lug 399 can be aligned 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 pointing outward from the same side of the intermediate shaft 306, as shown). FIG. 21 and 22 (As shown).

[0236] In some embodiments, the knob 314 may 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.

[0237] In some embodiments, during assembly, the sleeve element 391 may be mounted on and / or around the proximal portion 310 of the intermediate shaft 306. Anchors 386 may then be positioned adjacent to the sleeve element 391 on and around the intermediate shaft 306. In some embodiments, when the intermediate shaft 306 rests on a relatively flat surface (e.g., a table), the delivery device 300 may be positioned such that the translucent markings on the distal portion 309 point upwards (e.g., away from the table, which would appear...). FIG. 21 In the plane of the page, and the anchor 386 can be positioned such that the alignment lug 399 points away from the user (e.g., a person assembling the equipment), as... FIG. 21 As shown. For example, in FIG. 21 In this configuration, the flat surface of the table can be within the plane of the page. After this part is aligned, the anchor 386 can be (e.g., via UV bonding) attached to the intermediate shaft 306, and the sleeve element 391 can then be positioned on the radial extension 389 of the anchor 386.

[0238] In some embodiments, the assembly method can further include coupling the adapter 312 onto 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 a circumference of the intermediate shaft 306. FIG. 21 and 22 In this way, during the implantation procedure, a 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 implantation site, as further described below.

[0239] 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.

[0240] 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 FIGS. 1-3 includes the knob 2500 instead of the knob 314.

[0241] 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 a user cannot grasp or rotate the adapter 312 independently of the knob 2500.

[0242] In some embodiments, the outer housing 2502 can include one or more gripping elements 2504 configured to increase traction or grip for a user to rotate the knob 2500. In some embodiments, as shown in FIGS. 102-107As shown, 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.

[0243] 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 FIGS. 25A and 25B, 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 around the intermediate shaft 306 and the inner components of the knob 2500, thereby forming the knob (e.g., knob assembly) 2500. FIG. 103 and FIG. 104 and 105 As shown in the exploded view of FIGS. 25A and 25B, 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 around the intermediate shaft 306 and the inner components of the knob 2500, thereby forming the knob (e.g., knob assembly) 2500.

[0244] Similar to the knob 314 of FIGS. 3A-3E, 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. 25C. FIGS. 15-22 FIG. 106 and 107 As shown in the cross-sectional side view of FIG. 25C, the anchor 386 is configured to couple around the intermediate shaft 306 and interface with the sleeve element 391, as described above with reference to the knob 314 of FIGS. 3A-3E (and as shown in FIG. 3C). FIGS. 15-22 FIG. 106 and 107 As shown in the cross-sectional side view of FIG. 25C, the anchor 386 is configured to couple around the intermediate shaft 306 and interface with the sleeve element 391, as described above with reference to the knob 314 of FIGS. 3A-3E (and as shown in FIG. 3C).

[0245] As described above with reference to the knob 314 of FIGS. 3A-3E, the outer housing 1502 is configured to couple around and onto the anchor 386 and receive the sleeve element 391 and / or grip around 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 around the proximal end of the sleeve element 391. FIGS. 15-22 FIGS. 104-107

[0246] The outer housing 2502 can further include an inner cavity 2512 (at a proximal end thereof) that is configured to receive the adapter 312 therein​​​​FIGS. 104-107 ). 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 around 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 that is 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 a closed outer housing 2502 FIG. 102 、 103 , 106 and 107).

[0247] The outer housing 2502 can further include an extension portion 2556 that extends outwardly at an angle from the main body of the outer housing 2502. A portion of the inner cavity 2512 can be formed within the extension portion 2556 and is configured to receive the second port 340 of the adapter 312. In some embodiments, the extension portion 2556 can include a third aperture 2558 (formed by the two halves of the outer housing 2502 when coupled together) that is configured to fit around the second port 340 FIG. 104 and 107 ). The open end of the second port 340 can extend out and away from the third aperture 2558.

[0248] In alternative embodiments, rather than receiving the adapter 312 within the inner cavity 2512, the adapter and the outer housing 2502 can be integrated together (e.g., formed or molded as one piece).

[0249] 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 that extends from an inner surface of the outer housing 2502 FIGS. 104-106 .

[0250] 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 FIG. 104 and 107As shown, during assembly, the alignment lugs 399 can be aligned with the second port 340 of the adapter 312 such that they extend outward in the same relative direction (e.g., both point outward from the same side of the intermediate shaft 306, as shown) relative to the central longitudinal axis 320. In some embodiments, the alignment lugs 399 can be coupled to the second port 340 of the adapter 312 (e.g., via a press fit, a friction fit, an adhesive, etc.). FIG. 104 and 107 as shown).

[0251] In some embodiments, the knob 2500 can be assembled onto the proximal portion 310 of the intermediate (e.g., balloon) shaft 306 in the same or similar manner as the knob 314, as described above with reference to FIGS. 15-22 .

[0252] For example, 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 markers on the distal portion 309 are pointing upward (e.g., away from the table), and the anchor 386 can be positioned such that the alignment lugs 399 are pointing away from the user. 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.

[0253] In some embodiments, the assembly method can further include bonding the adapter 312 to the intermediate shaft 306 such that the second port 340 is pointing 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. In this manner, during an implantation procedure, a user can know the initial (e.g., starting) position of the radiopaque markers on the distal portion 309 of the 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 described further below.

[0254] The outer housing 2502 can then be positioned around the anchor 386 and the adapter 312 (e.g., such that the alignment lugs 399 are positioned within the second port 340 of the adapter 312, as shown). FIGS. 104-107). In some embodiments, this can include positioning the first housing portion 2506 and the second housing portion 2508 around the anchor 386 and coupling them to the anchor 386, thereby coupling the distal ends of the first housing portion 2506 and the second housing portion 2508 to each other. The cap 2518 can then be coupled to the proximal end 2516 of the knob 2500, thereby coupling the proximal ends of the first housing portion 2506 and the second housing portion 2508 to each other. These connections can allow the first housing portion 2506 and the second housing portion 2508 to be held together without the use of adhesives or otherwise fasteners.

[0255] In some embodiments, the outer housing 2502 can include one or more indicators 2522 (e.g., markings) that indicate to a user which way the knob 2500 should be rotated in order to align a radiopaque marker (e.g., the marker 500 or any other marker described herein) on a distal portion of the delivery device with a guidewire that is being advanced through the 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 which way 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

[0256] For example, if a radiopaque marker (e.g., the marker 600 or another marker described herein) on a distal portion of the delivery device 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 a 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 a 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. 12A-12C, 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 180 degrees apart from each other around the knob 2500. FIG. 102 103

[0257] ​​​In some embodiments, the presence of the knob 314 or knob 2500 for rotating the intermediate shaft 306 to achieve a desired rotational positioning of the prosthetic valve at the target implant site can reduce the likelihood of a user holding and using the adapter 312 to rotate the intermediate 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 encompassing the adapter 312 within the knob 2500, as shown in FIGS. 102-107 , the user is prevented from holding the adapter 312 and applying torque to the adapter 312.

[0258] In some embodiments, to further deter a user from holding 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 intermediate shaft 306 and the remainder of the adapter 312.

[0259] For example, FIGS. 23-27 embodiments, the proximal end portion 400 can be used as the proximal end portion of the delivery device 300 of FIG. 9 and 14 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, therefore, are similarly labeled in FIG. 23 .

[0260] As shown in FIG. 23 , the proximal end portion 400 can include a handle (e.g., handle portion), such as the handle 302 described above with reference to FIG. 9 and 14 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 FIG. 9 and 14 ) and have a proximal end portion 310 (shown in FIG. 23 ) 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 FIGS. 15-22 .

[0261] 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 (FIG. 23 and 26 For example, the adapter body 408 may include a proximal end configured to receive the intermediate shaft 306 therein. FIG. 26 ) first internal channel 410 ( FIG. 25 ).

[0262] In some embodiments, an additional adapter 442 may be arranged around the intermediate axis 306 between the knob 414 and the adapter body 408. FIG. 23 and 26 ).

[0263] 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 ).

[0264] 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.

[0265] 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.

[0266] The second port 406 is rotatably coupled to the adapter body 408. For example, as FIGS. 25-27As 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 can include a base portion 424 disposed about the proximal portion 412 of the adapter body 408.

[0267] A seal 426 can be disposed 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 about an outer surface (e.g., about 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.

[0268] 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.

[0269] The proximal portion 412 of the adapter body 408 can include an annular groove 434 that defines an annular passage 436 that extends about 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 fluidically 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 ).

[0270] In some embodiments, one or more apertures 440 extending radially inward from the annular groove 434 can fluidically connect the annular space 438 with the internal passage 432 FIG. 25 and 27 ). The annular space 438 can be fluidically 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 fluidically couple the internal passage 432 with the annular space 438.

[0271] 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., described above with reference to FIGS. 9-14The described balloon 318), while allowing the second port 406 to rotate about the adapter body 408 (e.g., about the central longitudinal axis 422). Thus, a user can be deterred from attempting to rotate the intermediate shaft 306 via rotation of the adapter 402 (e.g., because doing so can cause the second port 406 to rotate about the adapter body 408). Additionally, rotating the second port 406 can avoid torque from being applied to the adapter body 408 and the first port 404, thereby increasing the durability and longevity of the adapter 402 and preventing the bond between the adapter 402 and the intermediate shaft 306 from being compromised. Thus, the likelihood of more effectively and consistently deploying a balloon (e.g., the balloon 318) by injecting inflation fluid via the second port 406 can be increased. Moreover, having a rotatable second port 406 can allow a user to position the second port 406 in various locations (for injecting inflation fluid) without causing unnecessary movement of the delivery device.

[0272] As described above with reference to FIGS. 9-27 The delivery device 300 and / or similarly configured delivery devices described can include one or more features that facilitate rotational alignment of a radially compressed prosthetic valve disposed on a distal portion of the delivery device at a target implantation site.

[0273] As described above, it can be desirable to implant a prosthetic heart valve into a native valve with a delivery device (such as FIGS. 9-14 the delivery device 300) such that the commissures of the prosthetic heart valve are aligned with the commissures of the native valve. In some embodiments, to facilitate the desired rotational positioning of the prosthetic heart valve relative to the native valve, radio-opaque markers visible under medical imaging can 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) that is disposed at a valve mounting portion of the delivery device (e.g., the valve mounting portion 324) and thus in close proximity to the radially compressed prosthetic valve. As described further below, in some embodiments, the radio-opaque markers can be configured to indicate the location of selected commissures of the prosthetic valve after the prosthetic valve is radially expanded via inflation of a balloon (e.g., the balloon 318) of the delivery device. FIGS. 9-11

[0274] FIGS. 28-34B Embodiments of radio-opaque markers disposed on or embedded in a portion of a delivery device (such as the delivery device 300 shown) are shown. Although in the FIGS. 9-14 FIG. 28 , 29 ​​Delivery 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.

[0275] 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.

[0276] 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).

[0277] 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.

[0278] 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.

[0279] 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.

[0280] 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.

[0281] 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.

[0282] 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.

[0283] In some embodiments, as shown in FIG. 3A, the flared portion 331 can include a plurality of wings 330 (which can also be referred to as extension portions) that extend radially outward from the base portion 325 at an angle relative to the central longitudinal axis 320. The wings 330 can be spaced apart from one another around the circumference of the flared portion 331. As shown in FIG. 3A, in some embodiments, the marker 500 can be positioned on or embedded in one of the wings 330. In some embodiments, the marker 500 can be centered on one of the wings 330 such that it is centered along the central longitudinal axis 320. FIG. 28 FIG. 28

[0284] In some embodiments, the marker 500 can be a single (e.g., unique) radiopaque marker disposed on the distal shoulder 326. In some embodiments, the marker 500 can be the only (or single) radiopaque marker disposed on the distal end portion 309 of the delivery device 300.

[0285] In some embodiments, the distal end portion 309 of the delivery device 300 can include additional radiopaque markers (in addition to the marker 500).

[0286] Disposing the marker 500 on the distal shoulder 326 or another polymer body of the distal end portion of the delivery device can allow the marker 500 to be more visible under imaging (such as fluoroscopy) because the rest of the distal shoulder 326 can be more or not radiopaque and thus can be more or not visible in a fluoroscopy image. For example, as shown in the example fluoroscopy image 550, the marker 500 is visible and stands out under fluoroscopy because the distal shoulder is not radiopaque (except for the marker 500). In contrast, the prosthetic valve frame 552 is radiopaque and visible under imaging. Thus, a radiopaque marker positioned on and / or in the prosthetic valve itself can be more difficult to see under imaging because the valve frame appears relatively dark in the image 550. FIG. 29

[0287] As also shown in FIG. 3A, a guidewire 554 that extends through the center of the distal end portion 309 of the delivery device (e.g., through the inner lumen of the inner shaft 308) is visible under fluoroscopy, 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 described further below, when the marker 500 is disposed directly behind or directly in front of the imaging view, the marker 500 can appear to overlap with the guidewire. FIG. 29

[0288] ​​​​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

[0289] 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.

[0290] 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).

[0291] ​​During the implantation procedure, a selected imaging view (e.g., a fluoroscopic imaging view) can be used to visualize the distal portion of the delivery device relative to the surrounding native anatomy, including marker 500 and the radially compressed prosthetic valve (e.g., frame 552). Based on existing knowledge of the location of the selected commissure of the native valve (where the prosthetic valve will be implanted) within the selected imaging view, the user can rotatably align the distal portion of the delivery device at the target implantation site such that marker 500 is aligned with a known location of the selected commissure in the selected imaging view, or that marker 500 is positioned in a specific location within the selected imaging view (e.g., directly posterior), and deployment of the prosthetic valve in this orientation will result in alignment of the commissure between the prosthetic valve and the native valve.

[0292] For example, in some imaging views, a selected commissure of the native valve can be positioned directly behind the imaging view. Therefore, by aligning the mark 500 on the delivery device with the commissure between the native and prosthetic valves, the prosthetic valve can be implanted within the native valve with the commissure aligned. FIG. 58 , 61 Exemplary fluorescence fluoroscopic imaging views obtained during a prosthetic valve implantation procedure and used to guide the delivery device toward the native valve are shown in Figures 63 and 64, as further described below.

[0293] To achieve the desired positioning of the marker within a 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 the 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 relative to the guidewire within the imaging view (e.g., in front of and behind the imaging view) can be more easily identified.

[0294] FIGS. 30-34B An example embodiment of such asymmetrical markings, which allows a user to distinguish between two different locations of the markings within an imaging view, is shown. For example, in some embodiments, the asymmetrical markings are configured such that a user viewing the imaging view can distinguish whether the markings are positioned in front of or behind the fluorescence fluoroscopic imaging view. FIGS. 30-34B The markings shown can be positioned on the delivery device, as referenced above. FIG. 28 and 29 Described. For example, in some embodiments, FIGS. 30-34B The marking shown can replace the distal shoulder 326 of the distal portion 309 of the delivery device or the marking 500 on the polymer body. FIG. 28 and 29 ).

[0295] 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).

[0296] 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.

[0297] 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.

[0298] 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, where the "C" is 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.

[0299] 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

[0300] FIG. 32A and 32B respectively illustrate a side view and a perspective view 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) such 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.

[0301] In alternative embodiments, the marker 600 can be oriented differently on the distal shoulder than FIG. 32A and 32B illustrated, such 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.

[0302] FIGS. 33-34B illustrates a marker 600 shaped as the letter "E" and which can be oriented differently on the distal shoulder 326 of the delivery apparatus 300 than​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.

[0303] 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.

[0304] 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.

[0305] In some embodiments, the E-shaped asymmetric mark 650 can be replaced FIG. 32A and 32B Mark 600 on the delivery device shown.

[0306] 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.

[0307] 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.

[0308] 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.

[0309] 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.

[0310] 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

[0311] 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).

[0312] An example embodiment of a radiopaque marker 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 FIGS. 1-6 FIG. 1 and 35B is shown in FIGS. 97-101E. FIG. 2A The prosthetic valve 704 is shown in a radially compressed configuration (e.g., state) (such as when it is arranged around and crimped onto a delivery apparatus), and FIG. 35A The prosthetic valve 704 is shown in a radially expanded configuration (e.g., state). 2B FIG. 35B FIG. 2A

[0313] ​​​​As referenced above FIG. 35A and 2B The introduction and such FIG. 35E and 35B As shown, in some embodiments, the fusion portion 702 of the prosthetic valve 704 may include an attachment member 706 arranged across units (e.g., fusion units) 708 of the frame 710 of the prosthetic valve 704. In some embodiments, the attachment member may include fabric, flexible polymer, etc., arranged on the unit 708. As explained herein, the unit 708 may be formed by the struts 712 of the frame 710. The attachment member 706 may be arranged across the unit 708 and secured to the struts 712 of the frame 710 forming the unit 708 via fasteners 714 (e.g., sutures). Additionally, adjacent portions of the two leaflets 716 of the prosthetic valve 704 may be connected to the attachment member 706 to form the fusion portion 702.

[0314] In some embodiments, the connecting lugs of two adjacent leaflets 716 are on the inner surface of the attachment member 706. FIG. 35A As shown below, the inner surface is coupled to the attachment member 706, and a mark 700 is provided on the outer surface 724 of the attachment member 706. The inner surface may be arranged opposite the outer surface 724, facing the interior of the prosthetic valve 704.

[0315] In some embodiments, such as FIG. 35A and 35B As shown, a mark 700 may be arranged on the central region of the joining unit 708. For example, in some embodiments, the mark 700 may be sewn to the central region of the attachment member 706 via one or more fasteners (e.g., stitches) 722.

[0316] In some embodiments, the mark 700 may be shaped and positioned such that it fits within the unit 708 when the frame 710 is in a radially compressed configuration, as... FIGS. 28-34B As shown.

[0317] In some embodiments, the connecting part unit 708 may be arranged at the outflow end 718 of the prosthetic valve 704.

[0318] In some embodiments, the designation 700 comprises tantalum or another radiopaque material described herein or known in the art, which is formed or laser-cut into a transaxial reflective asymmetric shape, similar to the referenced above. FIG. 35B Described.

[0319] In some embodiments, the prosthetic valve 704 includes a skirt 720 arranged around the frame 710 of the prosthetic valve 704 at the inflow end (e.g., the end arranged opposite to the outflow end 718). FIG. 35A ).like FIGS. 35C-35H and35B As shown, when the connecting part unit 708 is arranged at the outflow end 718 of the prosthetic valve 704, the connecting part unit 708, including the mark 700, can be spaced apart from the skirt 720 in the axial direction.

[0320] FIGS. 35C-35H Another exemplary embodiment is shown, in which a radiopaque marker 750 is attached to a junction within a unit 708 of a prosthetic valve. FIG. 35A The prosthetic valve shown can be with FIGS. 35C-35H and 35B The prosthetic valve shown is the same as the 704 prosthetic valve, and therefore FIGS. 35C-35H It was marked accordingly. However, in FIG. 35C In this structure, there are two attachment members arranged across unit 708 and attached to the support column 712 forming unit 708. The connecting lug 754 and the mark 750 of the leaflet 716 can be sewn into different attachment members in the two attachment members.

[0321] For example, the attachment member 706 to which the connecting lug 754 of leaflet 716 is attached can be the first attachment member 706. FIGS. 35C-35G , 35D and 35H), and marking 750 can be attached to the second attachment member 752 ( FIG. 35A ).

[0322] Marker 750 may resemble mark 700 and other non-transmissive marks described herein. For example, mark 750 may be configured (e.g., shaped and sized) such that when frame 710 is in a radially compressed configuration (e.g., as... FIG. 35I As shown), mark 750 fits within unit 708.

[0323] exist FIG. 35A An exemplary embodiment of the marker 750 is shown. The marker 750 may be elliptical and have a first (upper) hole 726 and a second (lower) hole 728 configured to receive fasteners (e.g., sutures) for securing the marker 750 to the attachment member, as further described below. In some embodiments, the marker may include more or fewer than two holes (e.g., one, three, four, etc.) for receiving fasteners. In some embodiments, the marker 750 may have different shapes configured to engage within the unit 708 when the frame 710 is radially compressed, such as other marker shapes described herein and one of the embodiments (e.g., reference to...). FIG. 35A , 35B (and 35J-35P).

[0324] In some embodiments, the mark 750 may be shaped into letters of the alphabet (e.g., such as...). FIG. 35A and 35B (As shown).

[0325] 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 .

[0326] 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.

[0327] 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.

[0328] 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”).

[0329] 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 .

[0330] 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.

[0331] 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.

[0332] In some embodiments, the second attachment member 752 can comprise a similar or identical fabric material as the first attachment member 706.

[0333] In some embodiments, the second attachment member 752 can be secured to the strut 712 via additional fasteners (e.g., sutures).

[0334] 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.

[0335] 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-35PTherefore, metal-to-metal contact between the marker 750 and the frame 710 on the frame and / or any abrasive contact between the marker 750 and the outer side (e.g., outer surface) of the frame 710 can be avoided. Additionally, contact between the marker 750 and the leaflet (which is fixed to the inner first attachment member 706) is also avoided by securing the marker 750 to the external second attachment member 752.

[0336] In some embodiments, the marker 750 may be secured to the post 712 using a suture pattern that avoids the tissue of the leaflet 716. In some embodiments, additional material provided by the second attachment member 752 may also protect the end and suture used to secure the joint lug 754 to the first attachment member 706, thereby making the joint stronger and more durable.

[0337] 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 commissure during the implantation procedure, thereby achieving the desired commissure alignment, as described herein. Additionally, this radiopaque marker 750 can also provide identification of the location of the commissure of the prosthetic valve after implantation and during any future interventional procedures.

[0338] FIG. 35L Another embodiment of a radiopaque marker is shown, which is configured to be attached to a junction within unit 708 of the prosthetic valve, to another attachment member (which is then attached to unit 708), or to another skirt or fabric material (e.g., such as...) directly below the junction. FIGS. 35J-35P (As shown). For example, in some embodiments, FIGS. 35A-35B Any of the markings shown can replace marking 700 on the prosthetic valve 704. FIG. 35C ) or mark 750 on the second attachment member 752 FIGS. 35A-35P -H). Additionally... FIG. 35L Any markings shown may be attached directly and / or axially below the location of the joint to additional skirt or fabric material (such as...). FIGS. 35J-35P (As shown).

[0339] FIGS. 35J-35P The exemplary markers shown have different shapes or configurations. In some embodiments, the shape of the markers and / or the mounting location on the valve may be selected based on the valve's geometry and spatial constraints (e.g., the size of the frame units). In some embodiments, when the frame 710 of the prosthetic valve is in its radial compression and radial expansion configuration, FIG. 35J One or more of the markings shown can be shaped and sized to fit within unit 708.

[0340] 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).

[0341] 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).

[0342] 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).

[0343] Markers 766, 770, 774, and 776( FIGS. 35J-35LEach of the markers 786, 792 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, 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

[0344] FIGS. 35M-35P Further exemplary 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).

[0345] For example, FIG. 35N Exemplary 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 marker 786 includes 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. As 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.

[0346] FIG. 35M Another exemplary 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.

[0347] 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.

[0348] 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.

[0349] 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.).

[0350] 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.

[0351] Figures 97-99BOne embodiment is shown in which the radiopaque marker 750 is directly attached (e.g., sutured) to the attachment member 730. As shown in Figure 97 The attachment member 730 can include first and second side portions 732a, 732b that laterally protrude from a central portion 734 (or central region), as shown. The attachment member 730 can further include an upper lug 736 and a lower lug 738 that protrude from upper and lower edges, respectively, of the central portion 734. Further details regarding attachment members for cells used to secure commissure posts of adjacent leaflets to a frame of a prosthetic valve are described in U.S. Patent Publication No. 2018 / 0028310, which is incorporated by reference herein.

[0352] As shown in Figure 97 The marker 750 is directly secured to the central portion 734 of the attachment member 730 by one or more sutures 740 that form one or more knots on the outside of the marker 750. The attachment member 730 can then be folded and secured to a commissure post of a leaflet such that the marker 750 is disposed on a radially outwardly facing surface 742 of the attachment member 730 (e.g., facing away from the leaflet) Figure 98A and 98B ) or on a radially inwardly facing surface of the attachment member 730 (e.g., a surface disposed opposite the radially outwardly facing surface 742 and facing the commissure post of the leaflet) Figure 99A and 99B For example, when the marker 750 is secured to the radially outwardly facing surface 742 of the attachment member 730, the marker 750 faces outwardly and away from the leaflet and the interior of the frame 710 when secured to the cell 708 Figure 98B In contrast, when the marker 750 is secured to the radially inwardly facing surface of the attachment member 730, the marker 750 faces inwardly toward the leaflet when secured to the cell 708 Figure 99B Thus, as shown in Figure 99A and 99B the marker 750 is disposed behind the attachment member 730.

[0353] Figures 100-101E Another embodiment is shown in which the radiopaque marker 750 is attached (e.g., sutured) to an elongated flap 744 (or extension) of the attachment member 746. As shown in Figure 100 The attachment member 746 is similar to the attachment member 730 of Figure 97 except that it includes a longer flap 744 (rather than a shorter upper lug 736) that extends from the central portion 734. As shown in Figure 101A -E, the marker 750 can be attached to the flap 744 and the commissure formed with the attachment member 746 by one or more sutures (or other similar fasteners), such as 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) to the central portion 734 of the connection member 746.

[0354] 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

[0355] The flap 744 can then be folded over the outer surface 705 of the central portion 734 of the connection member 746, over the sutures that extend outward from the outer surface 705 for connecting the commissure tabs of adjacent leaflets to the connection member 746. Figure 101A Therefore, 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

[0356] The first suture 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 suture 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

[0357] In some embodiments, the free ends of the first suture 709 can be threaded through a looped portion 713 of the first suture 709 that is arranged on each side of the flap 744, under the flap 744. Figure 101C The first suture 709 is then tightened against the flap 744, as shown. Figure 101D

[0358] The free (loose) ends of the first suture 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

[0359] 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

[0360] 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.

[0361] 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.

[0362] 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. ​​

[0363] 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.

[0364] 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.

[0365] 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 ​The distal tip portion 328 can thus act as a proximal shoulder on the proximal end 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 apparatus to the target implant 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, moving the proximal end portion of the balloon 318 into the interior of the distal tip portion 328. In some embodiments, the distal tip portion 328 can include internal and / or external expansion cuts or grooves that provide flexibility to the distal tip portion 328 and allow it to expand radially outward as it moves over the proximal end portion of the balloon 318, increasing its ability to act as a balloon shoulder and prevent axial movement of a radially compressed prosthetic valve mounted around the balloon 318 at the valve mounting portion 324.

[0366] In some embodiments, expansion cuts of the distal tip portion arranged along the inner surface of the distal tip portion can extend axially along the inner surface (relative to the central longitudinal axis of the delivery apparatus). However, these axially extending expansion cuts can cause problems when rotationally aligning the distal end portion of the delivery apparatus at the target implant site as described herein, when the balloon shaft (e.g., the intermediate shaft 306) that the balloon 318 is mounted to is rotated. For example, the folds of the collapsed balloon 318 (as described above with reference to FIGS. 6A-6C) can get caught in the axially extending internal expansion cuts of the distal tip portion during rotation of the rotating balloon or intermediate shaft. An example of such axially extending expansion cuts can be found in U.S. Patent No. 9,061,119, which is incorporated by reference herein. Figure 36 and 37 Thus, it can be desirable to have a distal tip portion that is configured to radially expand over the proximal end portion of the balloon 318 while also allowing the balloon 318 to more easily slide within the distal tip portion without the folds of the balloon getting caught when the intermediate shaft of the delivery apparatus is rotated.

[0367] Thus, it can be desirable to have a distal tip portion that is configured to radially expand over the proximal end portion of the balloon 318 while also allowing the balloon 318 to more easily slide within the distal tip portion without the folds of the balloon getting caught when the intermediate shaft of the delivery apparatus is rotated.

[0368] Figures 38-41 An embodiment of the distal end portion 309 of the delivery apparatus is shown in which the outer shaft 304 includes a distal tip portion 900 mounted on the distal end of the outer shaft 304, and in certain configurations, the balloon 318 includes a radial indentation 334 Figure 40 and 41 In some embodiments, the distal tip portion 900 can be the distal tip portion 328 of Figure 9 and 11 .

[0369] 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 ).

[0370] 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.

[0371] 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.

[0372] 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.

[0373] 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.

[0374] 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 ones of the inner expansion grooves 902 are recessed into an inner surface of the distal tip portion 900. Figure 38 ).

[0375] 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.

[0376] 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 getting stuck within the inner expansion groove 902.

[0377] 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.

[0378] 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 end portion 332 of the balloon 318 can extend over the wider flared portion 331 of the distal shoulder 326 (e.g., which can be formed by the wing 330), then radially inwardly recess toward the base portion 325 of the distal shoulder 326, and then radially outwardly extend back toward the proximal end of the nose cone 322, thereby forming a radial recess. Figure 40 A state of the balloon 318 including the radial recess 334 in the distal end portion 332 is shown prior to crimping the prosthetic valve onto the valve mount portion 324 and advancing the distal tip portion 900 over the proximal end portion 333 of the balloon 318.

[0379] After crimping the prosthetic valve onto the valve mount portion 324 and advancing the distal tip portion 900 over the proximal end portion 333 of the balloon 318 (as shown in FIG. 9B), the fluid disposed within the proximal end portion 333 of the balloon 318 is distally displaced within the balloon 318 and pushed to the distal end portion 332 of the balloon 318. The radially recessed distal end portion 332 of the balloon 318 can then radially expand (e.g., partially inflate) to an expanded state 924 as shown in Figure 41 Figure 41 (phantom) and Figure 26 (phantom) shown. The radial recess 334 can be configured (e.g., sized) such that the distal end portion 332 can receive the displaced fluid without radially expanding portions of the balloon 318 within the valve mount portion 324, thereby preventing an increase in the crimped profile of the prosthetic valve 922.

[0380] Prior to inflating the balloon 318 to deploy the prosthetic valve 922 at a target implant site, the distal tip portion 900 can be moved axially away from the prosthetic valve 922 and out of the balloon 318 (by pulling the outer shaft 304 proximally relative to the intermediate shaft 306 or by pushing the intermediate shaft 306 distally relative to the outer shaft 304). The prosthetic valve 922 can then be deployed and radially expanded by inflating the balloon 918.

[0381] When the balloon 318 is inflated (e.g., when the distal end portion of the delivery apparatus and the prosthetic valve have reached a target implant site, such as a native valve), the balloon 318 unwinds (e.g., opens) to its expanded state, thereby radially expanding the prosthetic valve to its radially expanded state. When the balloon 318 is expanded and its folds or pleats 390 are opened 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 apparatus prior to inflating the balloon 318. In some embodiments, during manufacturing of the delivery apparatus, 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 apparatus manufactured in the same manner).

[0382] 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 apparatus such that a selected commissure of the prosthetic valve is offset from a marker (e.g., Figure 28 the marker 500 of the delivery apparatus 100, Figures 30-32B the marker 600 of the delivery apparatus 200, or Figures 33-34B the marker 650 of the delivery apparatus 300) on the delivery apparatus 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.

[0383] For example, deploying the prosthetic valve by inflating the balloon after aligning the marker on the delivery apparatus 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 apparatus can be configured to indicate the circumferential position of the selected commissure of the prosthetic valve after valve deployment.

[0384] 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 apparatus 300 is shown, with a selected commissure (indicated by the dashed line in Figure 42 ) 930 being circumferentially offset from the marker 600 by a predetermined amount 932. As described above, upon deployment of the prosthetic valve 922 via inflation of the balloon, the prosthetic valve 922 can rotate a predetermined amount 932 as it radially expands 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.

[0385] In an alternative embodiment, the predetermined offset 932 may differ from the predetermined expansion amount of the prosthetic valve during deployment via balloon inflation. For example, as further described below, the predetermined offset may be determined based on a desired imaging view selected during the implantation procedure for viewing the delivery device in the heart (e.g., based on the known location of the target commissure of the native valve within the selected imaging view). In some embodiments, the predetermined offset may be determined based on the selected imaging view and a predetermined amount of rotation of the prosthetic valve during deployment.

[0386] To mount and roll a prosthetic valve onto the valve mounting portion of a delivery device at a predetermined position and / or orientation (e.g., circumferential position and / or orientation) relative to the delivery device (e.g., a radiopaque mark on another portion of the distal shoulder or distal portion of the delivery device), an mounting assembly can be used. The mounting assembly may include a first component and a second component, the first component being configured to abut an unrolled (e.g., at least partially radially extended) prosthetic valve, and the second component being configured to abut a portion of the distal portion of the delivery device (e.g., a portion located proximal to and / or near the valve mounting portion). The first and second components of the mounting assembly may be further configured to abut different sides of a rolling device. Thus, the mounting assembly can hold the prosthetic valve at a predetermined orientation and / or predetermined position relative to the delivery device within the rolling device. Then, after rolling the prosthetic valve onto the valve mounting portion of the delivery device, the prosthetic valve can be arranged in a radially compressed configuration at a predetermined position and orientation relative to the delivery device. For example, a radially compressed prosthetic valve can be positioned on a delivery device such that a selected commissure of the prosthetic valve is circumferentially offset by a predetermined amount from a mark (or other desired marker) on the delivery device (e.g., as shown in the image). Figure 42 (As shown).

[0387] Figures 43-52 Embodiments of various components that can be used in an mounting assembly configured to roll 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) at predetermined positions and orientations. The prosthetic valve can be rolled onto the valve mounting portion of the delivery device in various ways. In some embodiments, the rolling device (such as...) Figure 43 and 44 The shown curling device 1084 can be used to curl a prosthetic valve onto the valve mounting portion of a delivery device. As further described below, the curling device 1084 may include mating interfaces on opposite sides of the curling device 1084, the mating interfaces being configured to receive and mate with corresponding mating interfaces on the first and second parts of the mounting assembly.

[0388] Figure 43a 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.

[0389] 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 the positioning device 1072 shown in Figure 49 For example, the mating interface can include one or more mating structures 1096.

[0390] 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.

[0391] 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).

[0392] The distal opening 1006 can be configured to allow a portion of the delivery device to pass through it during a curling operation performed by the curling device 1084.

[0393] In alternative embodiments, the configuration of the curling device can be changed.

[0394] 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.

[0395] 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).

[0396] 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.

[0397] 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.

[0398] 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.

[0399] 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.

[0400] 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.

[0401] In some embodiments, the support portion 1012 may have a maximum diameter smaller than the diameter of the cylindrical coupling portion 1013.

[0402] 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.

[0403] 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.

[0404] 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.

[0405] In this manner, the support body 1010 can be configured to axially slide 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 axially slide 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

[0406] 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.

[0407] 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 ).

[0408] ​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.

[0409] For example, Figure 46 and 47 FIGS. 13A and 13B illustrate perspective views of a ring body 1038 that can be used with the support body 1010 from different sides. 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.

[0410] In some embodiments, alignment guides can be positioned on the ring body 1038 Figure 46 . The alignment guides 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 .

[0411] 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).

[0412] 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 ).

[0413] 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.

[0414] 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.

[0415] 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.

[0416] 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 ).

[0417] 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.

[0418] 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.

[0419] 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.

[0420] 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.

[0421] 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

[0422] 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 ).

[0423] 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.

[0424] ​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).

[0425] 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.

[0426] 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 ) of the crimping device 1084. Figure 43

[0427] 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. Figure 51

[0428] 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 ).

[0429] An exemplary method of operation of the system disclosed herein can include the following steps. Steps can be modified, excluded, or replaced as needed across embodiments.

[0430] 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

[0431] 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.

[0432] 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

[0433] 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.

[0434] ​​​​​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.

[0435] 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.

[0436] 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.

[0437] 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.

[0438] 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.

[0439] 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.

[0440] 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 ).

[0441] 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.

[0442] 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 ).

[0443] 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.

[0444] 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.

[0445] 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.

[0446] 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.

[0447] 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 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, respectively.

[0448] 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 .

[0449] 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

[0450] 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.

[0451] As shown in FIGS. 27A and 27B, 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. 27A and 27B, 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.

[0452] 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.

[0453] 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 .

[0454] 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 the annular body 1038 of 50. For example, in some embodiments, the method at 1200 may include rotatably aligning the prosthetic valve on a support portion of the support body such that one or more commissures of the prosthetic valve mate and align with corresponding indicators on the annular body (e.g., as shown in the image). Figures 65-68 (As shown). In an alternative embodiment, the alignment ring may be Figure 54 One of the alignment rings shown.

[0455] After aligning the commissure portion of the prosthetic valve onto the implant retainer device, method 1200 proceeds to 1204, which includes removing the alignment ring from the implant retainer device while the circumferentially aligned prosthetic valve remains attached to the implant retainer device.

[0456] At 1206, the method includes attaching a positioning device to a delivery device. In some embodiments, attaching the positioning device may include coupling a portion of the positioning device proximally to the valve mounting portion of the delivery device and the proximal portion of the inflatable balloon of the delivery device around the axis of the delivery device. In some embodiments, the positioning device may be coupled to the intermediate (e.g., balloon) axis of the delivery device and around the intermediate (e.g., balloon) axis of the delivery device (e.g., intermediate axis 306, as shown in the image). Figure 49 (As shown). The positioning device can be one of the positioning devices described herein (e.g., Figures 53-55 Positioning device 1072 or Figure 43 The positioning device 1100 or another positioning device configured to be coupled to the delivery device and the coiling device and to hold the delivery device in a desired circumferential orientation relative to the coiling device. For example, at 1206, the method may include coupling the positioning device to the delivery device such that when the positioning device is coupled to the coiling device, a translucent mark on the delivery device is held in the coiling device in a desired circumferential orientation.

[0457] Method 1200 proceeds to 1208 and includes placing (e.g., arranging, or coupling) the distal portion of the delivery device and the positioning device to the coiling device (e.g., Figure 28 and 44 The first side (e.g., proximal side) of the coiling device 1084 or another coiling device. For example, a flange portion of a positioning device including one or more mating elements can be coupled to the first side of the coiling device such that one or more mating elements mate with one or more corresponding mating elements on the first side of the coiling device. Thus, the distal portion of the delivery device coupled to the positioning device can be arranged within the coiling device, wherein the valve mounting portion is arranged within a portion of the coiling device configured to press against and coil the prosthetic valve. In this way, the valve mounting portions of the positioning device and the delivery device can be received within the coiling device in a predetermined circumferential orientation and position.

[0458] At 1210, the method includes placing the implant retainer device into a second side (e.g., distal side) of the coiling device. For example, at 1210, the method may include inserting the implant retainer device into the second side of the coiling device such that an alignment member of the implant retainer device is inserted into or mates with a corresponding mating structure or element of the coiling device. In this way, the implant retainer device and the prosthetic valve disposed on the implant retainer device can be received within the coiling device in a predetermined orientation. For example, when both the implant retainer device coupled to the prosthetic valve and the positioning device coupled to the delivery device are coupled to the coiling device, a selected commissure of the prosthetic valve can be marked (e.g., such as a radiopaque marker on the distal portion of the delivery device) in a circumferential direction relative to the central longitudinal axis of the delivery device. Figure 42 , 35A -35B or 42) one of the markings) offset predetermined amount.

[0459] At 1212, the method includes using a curling device to curl the prosthetic valve into a radially compressed state onto the valve mounting portion of the delivery device. In some embodiments, curling the prosthetic valve at 1212 may include curling the prosthetic valve into its radially compressed state around an inflatable balloon at the valve mounting portion. Additionally, in some embodiments, curling the prosthetic valve at 1212 may include curling the prosthetic valve into a radially compressed state on the valve mounting portion of the delivery device while maintaining a predetermined offset between the radiopaque marker and a selected commissure of the prosthetic valve (e.g., as shown in the image). Figure 51 As shown above). As further described below, a predetermined offset can be determined (e.g., pre-selected) based on a desired or selected imaging view used to image the distal portion of the delivery device during the implantation procedure and to rotatably align the prosthetic valve with the native anatomy (e.g., to achieve commissural alignment). During the curling at 1212, in some embodiments, the implant retainer device can automatically detach from the prosthetic valve and / or the curling device (e.g., as referenced above). Figure 57 and 52 (Described).

[0460] At 1214, the method includes removing the distal portion of the delivery device from the coiling device on which the prosthetic valve is coiled. At 1214, the method may further include removing (e.g., dissociating) the positioning device from the delivery device. In this way, the positioning device may be removably coupled to the delivery device, and the implant retainer device may be removably coupled to the prosthetic valve, as described above. After removal from the coiling device, the delivery device may then be ready for insertion into the patient's blood vessel and navigation to the patient's heart.

[0461] 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 FIG. 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 bladder covering the radially compressed valve (and thus moving the bladder rather than inflating a balloon to deploy the prosthetic valve) relative to a shaft of the delivery device.

[0462] 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 and in a predetermined orientation relative to the delivery device 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.

[0463] 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).

[0464] 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 .

[0465] 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. 31B and 34A-34B). Figure 29

[0466] 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 Figures 61-64 Thus, since 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 described further below.

[0467] As described further below with reference to Figure 58 , the 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.

[0468] 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.

[0469] 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).

[0470] 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.

[0471] 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.

[0472] 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).

[0473] 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.

[0474] 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.

[0475] 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 as the balloon 1312 is inflated. Figure 60As illustrated in the exemplary schematic diagram, when the target suture 1450 of the autologous valve 1452 is known to be directly behind a selected imaging view used for rotational positioning at the implantation site, and the marker 600 is aligned directly behind the selected imaging view, the prosthetic valve 922 can be rotated by an amount equal to a predetermined offset between the marker and the selected suture 930 of the prosthetic valve 922 (e.g., by means of...) when the prosthetic heart valve is radially compressed around the balloon. Figures 61-68 (As indicated by arrow 1454 in the image), thereby implanting the prosthetic valve 922 with the selected commissure 930 circumferentially aligned with the target commissure 1450 of the native valve 1452.

[0476] In an alternative embodiment, during inflation, as the prosthetic heart valve expands radially, the prosthetic heart valve rotates by an amount greater or less than the offset between the marker and the selected commissure when the prosthetic heart valve is radially compressed around the balloon. However, this offset can be predetermined based on existing knowledge of the location of the target commissure of the native valve within the selected imaging view. In this way, during 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, during balloon inflation, the prosthetic valve rotates and is implanted with the commissure aligned with the commissure of the native valve.

[0477] See below for reference Figure 61 An example of such rotational alignment and adjustment is described for the circumferential offset between the markers on the delivery device and the selected commissure of the radially compressed prosthetic heart valve for different imaging views.

[0478] exist Figure 62 A schematic diagram of a first embodiment of a more standard tricuspid valve imaging view 1500 of the native valve 1510 is shown. As described above, this tricuspid valve imaging view 1500 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 tricuspid valve imaging view 1500, the non-coronary apical valve 1502 and the left coronary apical valve 1504 of the native valve (e.g., the aortic valve) 1510 are arranged opposite each other in the view and are both overlapped by different portions of the right coronary apical valve 1506, wherein all three apical valves are aligned along the transverse axis 1508. Thus, as Figure 62 As shown in the cross-sectional view of the native valve 1510 in the tricuspid valve imaging view 1500, the selected commissure 1512 of the native valve 1510, which is located between the non-coronary artery apical valve 1502 and the left coronary artery apical valve 1504, is located directly behind the tricuspid valve imaging view 1500 at 1514. Figure 63The right coronary cusp 1506 is also shown to be located in the frontal view of the imaging view 1516.

[0479] In contrast, Figure 64 A schematic diagram of a second embodiment of a different right / left cusp overlap view 1550 of the native valve 1510 is shown, which can be used to visualize the delivery device in the patient's heart and rotationally align the prosthetic valve during the implant procedure, as described above. In the right / left cusp overlap view 1550, the left coronary cusp 1504 and the right coronary cusp 1506 overlap each other, and the non-coronary cusp 1502 is offset from the left coronary cusp 1504 and the right coronary cusp 1506. As Figure 61 As shown in the cross-sectional view of the native valve 1510 in FIG. 13B, for the right / left cusp overlap view 1550, the selected commissure 1512 is circumferentially offset from the frontal view 1514 of the imaging view.

[0480] It should be noted that, in alternative embodiments, a different commissure of the native valve (other than the commissure disposed between the non-coronary cusp and the left coronary cusp) can be the selected commissure between which the predetermined offset is based at least in part for the marking and the selected commissure of the prosthetic valve.

[0481] Thus, for the two different imaging views shown in FIGS. 13A and 13B, the circumferential offset between the radiopaque marker on the delivery device and the selected commissure of the radially compressed prosthetic valve can be different predetermined offset values. In some embodiments, the implant procedure can be performed in the same manner for the different imaging views (e.g., the methods at 1304, 1306, 1308, and 1310 can be performed using the different selected imaging views as described above), including rotationally aligning the radiopaque marker on the delivery device with the guidewire such that the marker is positioned in the frontal view of the imaging view (e.g., as shown in FIGS. 13A and 13B). However, the mounting of the prosthetic valve to the delivery device can be adjusted such that a different amount of circumferential offset between the marker and the selected commissure of the prosthetic valve is used for the different procedures using the different imaging views, where the amount of circumferential offset determined for the selected imaging view results in implanting the prosthetic valve in the native valve with the commissure aligned with the commissure of the native valve. Figure 59 63 Thus, for the two different imaging views shown in FIGS. 13A and 13B, the circumferential offset between the radiopaque marker on the delivery device and the selected commissure of the radially compressed prosthetic valve can be different predetermined offset values. In some embodiments, the implant procedure can be performed in the same manner for the different imaging views (e.g., the methods at 1304, 1306, 1308, and 1310 can be performed using the different selected imaging views as described above), including rotationally aligning the radiopaque marker on the delivery device with the guidewire such that the marker is positioned in the frontal view of the imaging view (e.g., as shown in FIGS. 13A and 13B). However, the mounting of the prosthetic valve to the delivery device can be adjusted such that a different amount of circumferential offset between the marker and the selected commissure of the prosthetic valve is used for the different procedures using the different imaging views, where the amount of circumferential offset determined for the selected imaging view results in implanting the prosthetic valve in the native valve with the commissure aligned with the commissure of the native valve. Figure 61 60 Thus, for the two different imaging views shown in FIGS. 13A and 13B, the circumferential offset between the radiopaque marker on the delivery device and the selected commissure of the radially compressed prosthetic valve can be different predetermined offset values. In some embodiments, the implant procedure can be performed in the same manner for the different imaging views (e.g., the methods at 1304, 1306, 1308, and 1310 can be performed using the different selected imaging views as described above), including rotationally aligning the radiopaque marker on the delivery device with the guidewire such that the marker is positioned in the frontal view of the imaging view (e.g., as shown in FIGS. 13A and 13B). However, the mounting of the prosthetic valve to the delivery device can be adjusted such that a different amount of circumferential offset between the marker and the selected commissure of the prosthetic valve is used for the different procedures using the different imaging views, where the amount of circumferential offset determined for the selected imaging view results in implanting the prosthetic valve in the native valve with the commissure aligned with the commissure of the native valve.

[0482] It should be noted that, Figure 62 63 ​​​The two imaging views shown are examples of two different imaging views that can be used during a valve implantation procedure to rotatably align the prosthetic valve at the native valve. However, it is possible to position the target commissure of the native valve in different locations relative to the selected imaging view, either directly behind (or in front of) it, and such other imaging views can also be used with the systems and methods described herein. In this way, the user can select from several possible imaging views and select (or target) the commissure (e.g., Figures 46-48 and 64 The circumferential position of the connecting part 1512 shown relative to the rear (or front) of the selected imaging view can be known (e.g., predetermined).

[0483] In some embodiments, different alignment rings (e.g., with) are used for mounting components. Figure 45 The ring body 1038 shown is similar to a ring body, or the indication on the alignment ring is arranged on the implant retainer device (e.g., such as...). Figures 65-68 and 48 Different indicators of the alignment position of one or more commissures of the prosthetic valve on the support body 1010 can be used for different selected imaging views in the valve implantation procedure.

[0484] Figure 65 Exemplary embodiments of different alignment rings are shown. These alignment rings can be used in an implantation assembly and are configured to rotatably align a prosthetic valve onto an implant retainer device, causing the prosthetic valve to curl onto a valve mounting portion of the delivery device in a predetermined circumferential orientation relative to a radiopaque mark on the distal portion of the delivery device. For example, the alignment ring can be configured such that the prosthetic valve is radially compressed onto the delivery device with a predetermined amount of circumferential offset from a selected commissure on a radiopaque mark on the distal portion of the delivery device, the predetermined amount being determined (e.g., selection) based on a selected imaging view used during the implantation procedure. In some embodiments, such as Figure 65 and 66 As shown, different alignment rings may be similar in overall shape and function, but have different arrangements of indicators or markings that are unique for the selected imaging view intended to be used. For example, different alignment rings with unique arrangements of indicators or markings can be configured to align the prosthetic valve on the implant retainer device in such a way that the selected commissure of the prosthetic valve is offset by an appropriate amount relative to the radiopaque markings on the delivery device, which aligns the commissure of the prosthetic valve with the native valve when the prosthetic valve is deployed from the delivery device with the radiopaque markings aligned with the guidewire, as described above.

[0485] Figure 61An 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).

[0486] 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.

[0487] 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.

[0488] 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.

[0489] 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.

[0490] 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.

[0491] 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.

[0492] 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 in FIG. 17, 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

[0493] Figure 1 and 66 two possible embodiments of individual alignment rings configured for use with different selected imaging views for a valve implantation procedure as described herein. However, it is also possible for additional alignment rings to be similarly configured as those shown in FIGS. 18 and 19 but with different orientations of the indicators (commissure markers) for different selected imaging views. In this way, in some embodiments, a user can select from a plurality of different alignment rings that are unique for a selected imaging view for an implantation procedure. Figure 65 Figure 67 and 66

[0494] Figure 67 Another embodiment of an alignment ring 1800 is shown in FIG. 18. 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 in FIG. 18, the alignment ring 1800 includes a first set of indicators 1802 and a second set of indicators 1804 that are circumferentially offset from one another. In one embodiment, the first set of indicators 1802 can be for use with an implantation procedure utilizing a tricuspid imaging view, and the second set of indicators 1804 can be for use with a different implantation procedure utilizing a right / left cusp overlap view. Figure 68

[0495] 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.

[0496] 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, and the second set of indicators 1804 can be arranged on an opposite second side (or surface) of the alignment ring 1800.

[0497] ​​​​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

[0498] 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 a 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

[0499] 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.

[0500] 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. ​​

[0501] 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.

[0502] 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.

[0503] 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.

[0504] 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).

[0505] 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.

[0506] 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.

[0507] 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.

[0508] 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.

[0509] 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.

[0510] 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 FIGS. 40) when the inflation fluid is removed from the balloon. 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 the inflation fluid is removed from the balloon. Figures 9-11

[0511] Conventional balloon covers can include two housing portions or halves that are configured to be arranged around and fit together over a distal portion of a delivery device that includes a balloon (e.g., the distal portion 309 of the delivery device 300 over which the balloon 318 is mounted, as shown in FIGS. 36 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 over the balloon onto the delivery apparatus (e.g., as shown in FIG. 40), the user can grasp the delivery apparatus and pull to remove the sleeve from the delivery apparatus. 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 over the balloon onto the delivery apparatus (e.g., as shown in FIG. 40), the user can grasp the delivery apparatus and pull to remove the sleeve from the delivery apparatus. Figure 54

[0512] However, when the delivery apparatus includes a positioning device coupled to a distal portion of the delivery apparatus (e.g., the positioning device 1100 coupled to the distal portion 309 of the delivery apparatus 300, as shown in FIGS. 36 and 40, or the positioning device 1300 coupled to the distal portion 1309 of the delivery apparatus 1300, as shown in FIGS. 42 and 44), the user can grasp the positioning device and pull to remove the sleeve from the delivery apparatus. Figure 49 and 55 However, when the delivery apparatus includes a positioning device coupled to a distal portion of the delivery apparatus (e.g., the positioning device 1100 coupled to the distal portion 309 of the delivery apparatus 300, as shown in FIGS. 36 and 40, or the positioning device 1300 coupled to the distal portion 1309 of the delivery apparatus 1300, as shown in FIGS. 42 and 44), the user can grasp the positioning device and pull to remove the sleeve from the delivery apparatus. Figure 57 ​​When 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

[0513] 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.

[0514] Figure 69 FIGS. 76B and 108-114 illustrate 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 FIGS. 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 FIGS. 76B and 108-114) coupled to the distal portion of the delivery device proximal of the valve mounting portion of the delivery device.

[0515] 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

[0516] 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 .

[0517] 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.

[0518] ​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 lumen in some embodiments). The lumen 2020 can be configured to receive a distal portion of a delivery device and a balloon mounted on the distal portion of the delivery device (e.g., the balloon 318 of the distal portion 309 of the delivery device 300, as shown in FIGS. 30-32). Figure 69 and 72 -75C) of the balloon 318 (e.g., a majority of the balloon 318 in some embodiments).

[0519] 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 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.

[0520] 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-lumen portion 2021 ( Figure 70 ) of the lumen 2020.

[0521] Each recess 2026 can be shaped to receive a portion of the distal 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 ).

[0522] 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. 30-32, 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

[0523] ​In some embodiments, the intermediate segment 2032 may be shaped (e.g., configured) to receive the intermediate portion 335 of the balloon and the portion of the delivery device 300 covered by the intermediate portion 335 (e.g., valve mounting portion 324).

[0524] In some embodiments, the proximal segment 2030 may be shaped (e.g., configured) to receive at least the distal portion of the proximal portion 333 of the balloon 318. In some embodiments, a further proximal portion of the proximal portion 333 of the balloon 318 may extend into a second portion 2012 of the first outer shell member 2002 or the second outer shell member 2004. Figure 70 and 72 In other embodiments, the proximal segment 2030 may be shaped to receive the entire proximal portion 333 of the balloon 318.

[0525] In this way, the shape or profile of the recess 2026 can be changed along the first length 2034 of the first portion 2010, the first length 2034 extending in the axial direction relative to the central longitudinal axis 2014. Figure 70 For example, such as Figures 108-114 As shown, the intermediate segment 2032 is narrower than each of the distal segment 2028 and the proximal segment 2030. In some embodiments, the width of the intermediate segment 2032 is constant along most of its length.

[0526] In other embodiments, each recess 2026 may include a distal segment 2028 and a proximal segment, the proximal segment being similar to the intermediate segment 2032 and extending from the distal segment 2028 to the second portion 2012. In such embodiments, the proximal segment may be configured to receive the intermediate portion 335 of the balloon and a portion of the delivery device 300 covered by the intermediate portion 335 (e.g., valve mounting portion 324). In some embodiments, the proximal segment may be further configured to receive the proximal portion 333 of the balloon 318, which, when positioned within the balloon cover 2000, may not have a diameter portion wider than the intermediate portion 335. Figure 69 An exemplary embodiment is shown below.

[0527] In some embodiments, the first length 2034 of the first portion 2010 may be longer than the second length 2036 of the second portion 2012.

[0528] In other embodiments, the second length 2036 of the second portion 2012 may be the same as or longer than the first length 2034 of the first portion 2010.

[0529] 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.

[0530] 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.

[0531] 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).

[0532] 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).

[0533] 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.

[0534] 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 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.

[0535] 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.

[0536] 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). Figure 71A The mating surface 2058 can be formed along the edges of the first wall 2050, the second wall 2052, and the third wall 2054.

[0537] 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.

[0538] ​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 in. The protrusion extends outwardly from the mating surface 2058, and the groove 2062 is recessed into the mating surface 2058.

[0539] 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).

[0540] 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.

[0541] 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.

[0542] 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.

[0543] 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 .

[0544] 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.

[0545] 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. 21A). Figure 72 and 72 As shown).

[0546] 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.

[0547] 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.

[0548] Additionally, in some embodiments (as shown in FIG. 21A), 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

[0549] 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., not fully enclosing) wall.

[0550] 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.

[0551] ​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).

[0552] 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 a 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 ).

[0553] 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.

[0554] 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).

[0555] Accordingly, when a user grasps the exterior of the second cover portion 2003 (e.g., to remove the sleeve 2064), any movement of the balloon cover 2000 does not result in movement of the positioning device 1100 relative to the delivery device, as the balloon cover 2000 does not directly contact the positioning device 1100. For example, if the balloon cover 2000 rotates, the rotation does not result in rotation of the positioning device 1100, thereby maintaining the positioning device in the specified and intended circumferential position relative to the delivery device. This can enable the prosthetic valve to be mounted on the valve mounting portion of the delivery device in the predetermined circumferential orientation relative to the radiopaque markers on the delivery device, as discussed herein (e.g., as discussed above with reference to Figures 74-75C FIG. 1).

[0556] In some embodiments, as shown in FIG. 21, the inner height 2076 can be less than the inner diameter 2074. Correspondingly, the second cover portion 2003 can have an outer height 2078 that is less than the outer diameter 2080 Figure 75B ). The reduced inner height 2076 and outer height 2078 of the second cover portion 2003 compared to the corresponding diameters can reduce the overall packaging space of the balloon cover 2000. This can reduce the material cost of the balloon cover itself and the packaging material used to contain the balloon cover. Accordingly, the inner diameter 2074 and inner height 2076 can be selected to be as small as possible to reduce the packaging space while still being large enough to prevent engagement with the positioning device Figure 75C ). ​

[0557] In some embodiments, the configuration of the openings 2046 in the fourth walls 2056 of the first and second housing members 2002, 2004 can result in the reduced inner height 2076 and outer height 2078.

[0558] In some embodiments, the openings 2046 can also allow a user to visualize the positioning device 1100 and the distal end portion 309 of the delivery device 300, which can allow for easier assembly of the balloon cover 2000 around the delivery device.

[0559] In other embodiments, the second cover portion 2003 can be cylindrical and the first and second housing members 2002, 2004 can have walls that completely enclose the positioning device therein without any openings. For example, Figure 76A and 76B FIG. 21 shows another example embodiment of a balloon cover 2100, which includes a first housing member 2102 and a second housing member 2104 that are configured to matingly engage one another and removably couple to one another.

[0560] ​The first and second housing members 2102 and 2104 can be configured similarly to the first and second housing members 2002 and 2004 of the balloon cover 2000( Figures 69-75C ), 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( Figures 69-75C ). Thus, the balloon cover 2100( Figure 76A and 76B ) can increase the packing space as compared to the balloon cover 2000(

[0561] 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 valve deployment at the implant site.

[0562] 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 and / or form two halves of an outer housing 2606 of the balloon cover 2600( Figure 110 ).

[0563] The outer housing 2606 and the balloon cover 2600 are described in Figure 110in exploded view in FIGS. 111 and 113, and in assembled configuration in various views of Figure 108 、 109 111 and 113. Further, Figure 113 shows a cross-sectional view of the balloon cover 2600, while Figure 114 shows one of the housing members (e.g., the first housing member 2602) arranged around the delivery apparatus.

[0564] 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 the balloon cover 2000. Figures 71A-71C

[0565] Each of the first housing member 2602 and the second housing member 2604 includes 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 each other (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.

[0566] 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 the 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 FIGS. Figure 110 、 113 and 114).

[0567] 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 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 flat surface.​

[0568] 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.

[0569] 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.

[0570] 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).

[0571] 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.

[0572] In this manner, the shape or profile of the recess 2626 can vary along the length of the first portion 2610. For example, as shown in FIGS. 26A-26C, the recess 2626 can have a first shape or profile along a first portion 2610a of the first portion 2610 and a second shape or profile along a second portion 2610b of the first portion 2610. Figure 110 , 113 As shown in FIGS. 26A-26C, the proximal section 2630 can be narrower than the distal section 2628.

[0573] In some embodiments, the length of the first portion 2610 can be longer than the length of the second portion 2612, as described above with reference to FIGS. 21A-21C. Figures 69-75C

[0574] The second portion 2012 of each of the first housing member 2602 and the second housing member 2604 can be configured (dimensioned and shaped) to be 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 mating engagement based on the length and / or dimensions of the positioning device (e.g., the positioning device 1100).

[0575] When the first housing member 2602 and the second housing member 2604 are assembled to one another (e.g., coupled together in mating engagement), the second portions 2612 of the first housing member 2602 and the second housing member 2604 can form a second cover portion 2603 and define a cavity 2638 Figure 108 and 111 -114). The cavity 2638 can be configured to receive the positioning device (e.g., the positioning device 1100, as shown in FIGS. 31A-31C) 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, in some embodiments, the overall dimensions of the cavity 2638 can be similar to the cavity 2038 of the balloon cover 2000, as described above, in addition to one or more cavities 2652 described further below. Figures 108-114

[0576] Similar to the balloon cover 2000 Figures 69-75C ), the inner surface of the wall of the second portion 2612 can define one half-cavity portion of the cavity 2638. In some embodiments, the second portion 2612 of the second housing member 2604 can be configured to be the same as or similar to the second portions 2012 of the first housing member 2002 and the second housing member 2004 of the balloon cover 2000 (see FIGS. 21A-21C, above). Figures 69-75C ​​However, the second portion 2612 of the first housing member 2602 can have a first wall 2650 (connected to the wall of the first portion 2610) that is shaped (e.g., keyed) to receive a portion of the positioning device 1100. For example, the first wall 2650 of the second portion 2612 of the first housing member 2602 can be shaped to form one or more cavities 2652 shaped to receive and retain a portion of the flange portion 1112 of the positioning device 1100 therein (e.g., as described above with reference to 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 the one or more cavities 2652 (e.g., as described above with reference to Figure 108 , 110 , 113 and 114).

[0577] 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. Accordingly, twisting of the balloon 318 can be avoided.

[0578] 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 retain a portion of the flange portion 1112 of the positioning device 1100 therein, as described above with reference to Figures 108-114 .

[0579] 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.

[0580] 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.

[0581] As described above, when assembled together, the first portion 2610 of the first and second housing members 2602 and 2604 can cover and enclose a portion of the distal end portion 309 of the delivery device and the balloon 318 (FIGS. 111-114) therein. 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 (FIGS. 111-114). Figure 108 、 109 and 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 (FIGS. 111-114). Figure 113 and 114 ).

[0582] Similar to the description above with reference to Figures 69-75C , the outer surface of the walls of the second portion 2612 of the first and second housing members 2602 and 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 of 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.

[0583] 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 the target implantation site.

[0584] As previously described, prior to crimping the prosthetic valve about the valve mounting portion 324, the balloon 318 can undergo a cycle of a de-gassing 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 b...

Claims

1. A prosthetic heart valve, comprising: A frame, the frame including a plurality of pillars forming a plurality of units of the frame arranged between an inlet end and an outlet end of the frame; Multiple leaflets are arranged within the frame; At least one connecting portion, the at least one connecting portion including an attachment member and connecting lugs of two adjacent leaflets, the attachment member being arranged across a selected unit of the plurality of units of the frame and attached to a post of the frame forming the selected unit, and the connecting lugs of the two adjacent leaflets being coupled to the attachment member. as well as A radiopaque marker is disposed on the attachment member of the ferrule, wherein the marker is configured to indicate the location of the ferrule of the prosthetic heart valve.

2. The prosthetic heart valve of claim 1, wherein the marking is asymmetrically reflected across an axis parallel to the central longitudinal axis of the prosthetic heart valve, the central longitudinal axis extending between the inlet and the outlet.

3. The prosthetic heart valve according to claim 2, wherein the markings are letters of the alphabet.

4. The prosthetic heart valve according to any one of claims 1-3, wherein the mark is sutured to the central region of the attachment member.

5. The prosthetic heart valve of claim 4, wherein the mark is disposed on a first side of the attachment member, the first side being arranged opposite to a second side of the attachment member to which the connecting lug is coupled, and wherein the first side is the radially outward side of the attachment member.

6. The prosthetic heart valve of claim 4, wherein the marking is disposed on the same side of the attachment member that is coupled to the connecting lug, the side being the radially inward side of the attachment member.

7. The prosthetic heart valve according to any one of claims 1-3, wherein the mark is disposed on the flap of the attachment member, the flap extending outward from the central portion of the attachment member, and wherein the flap is folded over the radially outward side of the central portion such that the mark is disposed between the flap and the radially outward side of the central portion, and wherein the connecting lug is coupled to the radially inward side of the central portion.

8. The prosthetic heart valve of claim 7, wherein the mark is secured to the central portion of the flap and the attachment member by a plurality of sutures, the plurality of sutures being used to secure the connecting lug to the central portion of the attachment member, and the plurality of sutures extending through an opening of the mark and a corresponding opening of the flap.

9. The prosthetic heart valve according to any one of claims 1-3, wherein the prosthetic heart valve further comprises a skirt disposed around the frame of the prosthetic heart valve at the inlet end of the frame.

10. The prosthetic heart valve according to any one of claims 1-3, wherein the attachment member comprises fabric sutured to a strut forming the frame of the selected unit.

11. A prosthetic heart valve, comprising: A frame, the frame including a plurality of pillars forming a plurality of units of the frame arranged between an inlet end and an outlet end of the frame; Multiple leaflets are arranged within the frame; At least one connecting portion, the at least one connecting portion including a first attachment member and connecting lugs of two adjacent leaflets, the first attachment member being arranged across a selected unit of the plurality of units of the frame and attached to a post of the frame forming the selected unit, and the connecting lugs of the two adjacent leaflets being coupled to the first attachment member. as well as A radiopaque marker is attached to a second attachment member, which is arranged across the selected unit and attached to the strut forming the selected unit. The second attachment member is arranged outside the first attachment member relative to the central longitudinal axis of the frame, wherein the marker is configured to indicate the location of the commissure of the prosthetic heart valve.

12. The prosthetic heart valve of claim 11, wherein the marking is disposed between the first attachment member and the second attachment member.

13. The prosthetic heart valve according to claim 11 or claim 12, wherein the mark is sutured to the central region of the second attachment member.

14. The prosthetic heart valve of claim 11 or claim 12, wherein the marking is asymmetrically reflected across an axis parallel to the central longitudinal axis extending between the inlet and the outlet.

15. The prosthetic heart valve according to claim 11 or claim 12, wherein the markings are letters of the alphabet.

16. The prosthetic heart valve of claim 11 or claim 12, wherein the second attachment member comprises fabric sutured to a strut forming the frame of the selected unit.

17. The prosthetic heart valve of claim 11 or claim 12, wherein the first attachment member and the second attachment member are secured to the strut of the frame forming the selected unit via the same suture, the suture extending through each of the first attachment member and the second attachment member and surrounding the strut of the frame forming the selected unit.

18. The prosthetic heart valve of claim 11 or claim 12, wherein the frame is radially compressible and expandable between a radially compressible configuration and a radially expandable configuration, and wherein the mark is shaped such that when the frame is in the radially compressible configuration, the mark fits within the selected unit.

19. A prosthetic heart valve, comprising: A frame, the frame including a plurality of pillars forming a plurality of units of the frame arranged between an inlet end and an outlet end of the frame; Multiple leaflets are arranged within the frame; At least one connecting portion, the at least one connecting portion including connecting lugs of two adjacent leaflets among the plurality of leaflets, the connecting lugs of the two adjacent leaflets being connected to each other, the at least one connecting portion being fixed to a support of the frame forming a selected unit among the plurality of units; as well as A radiopaque marker is attached to an attachment member that is arranged across the selected unit and attached to the strut forming the selected unit, wherein the marker is configured to indicate the location of the commissure of the prosthetic heart valve.

20. The prosthetic heart valve of claim 19, wherein the frame is radially compressible and expandable between a radially compressible configuration and a radially expandable configuration, and wherein the mark is shaped such that when the frame is in the radially compressible configuration, the mark fits within the selected unit.

21. The prosthetic heart valve of claim 19 or claim 20, wherein the marking is asymmetrically reflected across an axis parallel to the central longitudinal axis of the frame, the central longitudinal axis extending between the inlet and the outlet.

22. The prosthetic heart valve of claim 21, wherein the markings are letters of the alphabet.

23. The prosthetic heart valve according to claim 19 or claim 20, wherein the commissural lugs of the two adjacent leaflets are coupled to the attachment member on the inner surface of the attachment member, and the marking is disposed on the outer surface of the attachment member.

24. The prosthetic heart valve of claim 19 or claim 20, wherein the commissural lugs of the two adjacent leaflets are coupled to the attachment member on the inner surface of the attachment member, and the marking is provided on the inner surface of the attachment member.

25. The prosthetic heart valve of claim 19 or claim 20, wherein the mark is disposed on the flap of the attachment member extending outward from the central region of the attachment member, and wherein the flap is folded on the radially outward side of the central region such that the mark is disposed between the flap and the radially outward side of the central region, and wherein the connecting lug is coupled to the radially inward side of the central region.

26. The prosthetic heart valve of claim 19 or claim 20, wherein the attachment member is a first attachment member, and wherein the commissural lug of the two adjacent leaflets is coupled to a second attachment member, the second attachment member being arranged across the selected unit and attached to the strut forming the selected unit, the first attachment member being arranged outside the second attachment member relative to the central longitudinal axis of the frame.

27. The prosthetic heart valve of claim 26, wherein the mark is disposed between the first attachment member and the second attachment member, and wherein the first attachment member and the second attachment member are secured to the strut of the frame forming the selected unit via the same suture, the suture extending through each of the first attachment member and the second attachment member and surrounding the strut of the frame forming the selected unit.

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