Balloon cover for a delivery device for an expandable prosthetic heart valve

Abstract

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

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] The present disclosure relates to a balloon cover configured to receive a distal portion of a delivery device for a balloon-expandable prosthetic heart valve. Background Art

[0004] The human heart suffers from a variety of valvular diseases. These valvular diseases may lead to serious malfunction of the heart, ultimately requiring the repair of the native valve or replacement of the native valve with an artificial valve. There are many known repair devices (e.g., stents) and artificial valves, as well as many 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 to locations inside the body that are not easily accessible by surgery or that are desired to be accessible without surgery. In one specific example, a prosthetic heart valve can be mounted on the distal end of a delivery device in a curled state and advanced through the patient's vascular system (e.g., through the femoral artery and aorta) until the prosthetic valve reaches the implantation site in the heart. The prosthetic valve is then expanded to its functional size, for example, by inflating a balloon on which the prosthetic valve is mounted.

[0005] The balloon cover can be configured to encapsulate the distal portion of the delivery device, including the inflatable balloon mounted thereon, during transport and / or storage prior to use and / or during a degassing process. In some embodiments, a positioning device can be coupled to the distal portion of the delivery device, which can facilitate mounting the prosthetic heart valve on the distal portion of the delivery device in a desired circumferential orientation relative to the distal portion of the delivery device. However, during removal of the balloon cover, a user may inadvertently move (e.g., rotate) the positioning device relative to the delivery device. As a result, the prosthetic valve may subsequently be mounted on the balloon in an inappropriate circumferential orientation relative to the distal portion of the delivery device.

[0006] Therefore, there is a need for an improved balloon cover that prevents rotation of the positioning device relative to the delivery apparatus. Summary of the Invention

[0007] Described herein are embodiments of improved prosthetic valve delivery devices and methods for delivering a prosthetic valve to and implanting the prosthetic valve at the site of a native valve in a patient's heart, wherein one or more selected commissures of the prosthetic valve are aligned with one or more corresponding commissures of the native valve. In some embodiments, the disclosed delivery devices include an expandable balloon around which the prosthetic valve can be mounted in a radially compressed state for delivery to the native valve.

[0008] Various balloon covers and balloon cover assemblies for use with such delivery devices are also described herein. In some embodiments, the balloon cover can be configured to receive a distal portion of a delivery device. In some embodiments, the balloon cover can be configured to at least partially form a specific shape of a portion of a balloon mounted on the distal portion of the delivery device.

[0009] In a representative embodiment, a balloon covering for a delivery device includes a first shell member and a second shell member configured to cooperatively engage one another, wherein each of the first shell member and the second shell member includes a first portion and a second portion, the second portion having a greater width than the first portion, the width being defined in a direction perpendicular to a central longitudinal axis of the balloon covering. The first portion of the first shell member and the first portion of the second shell member define a first lumen configured to receive a distal portion of the delivery device and at least a portion of an expandable balloon mounted on the distal portion of the delivery device. The second portion of the first shell member and the second portion of the second shell member define a second lumen configured to receive a positioning device mounted on the distal portion of the delivery device proximal to a valve mounting portion of the distal portion of the delivery device.

[0010] In another exemplary embodiment, an assembly includes a delivery device comprising a first shaft and a second shaft, the second shaft extending through the first shaft and having a distal portion extending distally beyond the distal portion of the first shaft. The assembly further includes an inflatable balloon coupled to the distal portion of the first shaft and covering a valve mounting portion of the delivery device, the valve mounting portion being configured to receive a prosthetic valve in a radially compressed state, a positioning device coupled to the distal portion of the first shaft proximal to the valve mounting portion, and a balloon cover. The balloon cover includes first and second housing members, the first and second housing members being configured to cooperatively engage with each other around the balloon and the positioning device, each of the first and second housing members including a first housing portion and a second housing portion, wherein the first housing portion of the first and second housing members defines a first lumen configured to receive at least a portion of the balloon and the distal portion of the second shaft, and wherein the second housing portions of the first and second housing members define a second lumen configured to receive the positioning device.

[0011] In another representative embodiment, a balloon covering for a delivery device includes a first housing member and a second housing member configured to cooperatively engage with each other around a distal portion of the delivery device. Each of the first housing member and the second housing member includes a first housing portion, the first housing portion of the first housing member and the second housing member defining a first cavity, the first cavity being configured to receive at least a portion of a balloon covering a valve mounting portion of the distal portion of the delivery device. The balloon covering further includes a recessed sleeve including a first portion and a second portion, the first portion being configured to receive and couple to the first housing portion of the first housing member and the second housing member, the second portion including one or more recessed members, each of the one or more recessed members having a free end configured to move radially inward toward a central longitudinal axis of the balloon covering. The balloon covering further includes a coupling element configured to be disposed around the second portion of the recessed sleeve and to recess the one or more recessed members radially inwardly such that the one or more recessed members form a negative recess in the portion of the balloon surrounded by the recessed sleeve.

[0012] The above and other objects, features and advantages of the disclosed technology will become more apparent from the following detailed description, which is described in detail with reference to the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0013] Figure 1 is a perspective view of a prosthetic heart valve according to one embodiment.

[0014] Figure 2A is a perspective view of a prosthetic heart valve according to another embodiment.

[0015] Figure 2B yes Figure 2A A perspective view of a prosthetic valve of FIG. 1 is shown in FIG. 2 , wherein components on the outside of the frame are shown in transparent lines for illustration purposes.

[0016] Figure 3 is a perspective view of a delivery apparatus for a prosthetic heart valve, according to one embodiment.

[0017] Figure 4 is a schematic diagram of an exemplary heart showing the position of the coronary arteries relative to the aortic valve.

[0018] Figure 5A Illustrated is an exemplary positioning of a prosthetic valve in an aortic valve relative to the coronary arteries.

[0019] Figure 5B Another exemplary positioning of a prosthetic valve in an aortic valve relative to the coronary arteries is illustrated, wherein the prosthetic valve at least partially inhibits blood flow to the coronary arteries.

[0020] Figure 6A is a cross-sectional view of an aortic valve illustrating a first positioning of a prosthetic valve within the aortic valve, wherein commissures of the prosthetic valve at least partially block one or more openings to the coronary arteries.

[0021] Figure 6B is a cross-sectional view of an aortic valve illustrating a second positioning of a prosthetic valve within the aortic valve, wherein the commissures of the prosthetic valve are circumferentially aligned with the native commissures of the aortic valve, thereby maintaining access to the coronary arteries.

[0022] Figure 7 Illustrated is a leaflet cutting procedure in which the leaflets of the native aortic valve can be split at the location of the entrance to the coronary arteries to enable increased blood flow into the coronary arteries when a prosthetic heart valve is implanted within the aortic valve.

[0023] Figure 8A Illustrated is an exemplary prosthetic heart valve and an example of how native leaflets surrounding the prosthetic heart valve are split at the region of the frame of the prosthetic heart valve between two adjacent commissures resulting in an open cell in front of the entrance to the coronary arteries.

[0024] Figure 8B Pictured Figure 8A An exemplary prosthetic heart valve and how splitting native leaflets in a region of a frame of a prosthetic heart valve, including the commissures, does not result in open cells being disposed in front of the access to the coronary arteries.

[0025] 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.

[0026] Figure 10 yes Figure 9 Cross-sectional side view of the distal portion of the delivery device.

[0027] Figure 11 yes Figure 9 1 is a side view of a distal portion of a delivery device illustrating a distal tip portion of an outer shaft of the delivery device.

[0028] Figure 12 yes Figure 9 Schematic diagram of an embodiment of an intermediate shaft of a delivery device.

[0029] Figure 13 yes Figure 11 Cross-sectional side view of a detail portion of the coaxial shaft of the delivery device.

[0030] Figure 14 yes Figure 9 Cross-sectional side view of the handle of the delivery device.

[0031] Figure 15 is a first perspective view of an embodiment of a rotatable knob mounted on a proximal portion of a central shaft of a delivery device, the knob being configured to rotate the central shaft, thereby rotating an expandable balloon and a prosthetic heart valve radially compressed against the balloon.

[0032] Figure 16 yes Figure 15 A second perspective view of the knob.

[0033] Figure 17 yes Figure 15 Cross-sectional side view of the knob.

[0034] Figure 18 yes Figure 15 A cross-sectional view of an anchor of a knob configured to couple the knob to an intermediate shaft.

[0035] Figure 19 yes Figure 18 Perspective view of the anchor.

[0036] Figure 20 yes Figure 15 Exploded view of the outer housing of the knob.

[0037] Figure 21 It is installed on the proximal part of the intermediate shaft Figure 18 Side view of the anchor.

[0038] Figure 22 It is installed on the proximal part of the intermediate shaft Figure 15 A side view of the knob with one housing portion of the outer housing removed to show the anchor.

[0039] Figure 23 is a perspective view of an embodiment of a proximal portion of a delivery device comprising a handle, a rotatable knob, and an adapter.

[0040] Figure 24 yes Figure 23 A perspective view of an adapter in FIG. 1 , the adapter comprising a first port and a second port configured to rotate relative to a body of the adapter and the first port.

[0041] Figure 25 yes Figure 24 A cross-sectional view of the adapter.

[0042] Figure 26 is mounted on the proximal portion of the delivery device Figure 24 A cross-sectional view of the adapter.

[0043] Figure 27 is a rotational interface between the second port of the adapter and the body Figure 26 Detailed cross-sectional view of a portion of the adapter.

[0044] Figure 28 A side view of a distal portion of a delivery device is illustrated with exemplary radiopaque markers positioned on and / or embedded within the polymeric body of the distal portion of the delivery device.

[0045] Figure 29 Pictured Figure 28 Example fluoroscopic images of a distal portion of a delivery device including a radiopaque marker.

[0046] Figure 30 An embodiment of an asymmetric radiopaque marker that allows a user to distinguish between two different locations of the marker within an imaging view is illustrated.

[0047] Figure 31A is an exemplary fluoroscopic image illustrating a guidewire extending through a distal portion of a delivery device and a device disposed on or embedded within a portion of the distal portion of the delivery device and in a first orientation relative to the guidewire. Figure 30 Asymmetric markings.

[0048] Figure 31B is an exemplary fluoroscopic image illustrating a guidewire extending through a distal portion of a delivery device and a second orientation disposed on or embedded within a portion of the distal portion of the delivery device. Figure 30 Asymmetric markings.

[0049] Figure 32A is a side view of an exemplary delivery device, wherein Figure 30 An asymmetric marker is disposed on or embedded in the distal shoulder of the delivery device.

[0050] Figure 32B yes Figure 32A A perspective view of an exemplary delivery device, wherein Figure 30 An asymmetric marker is disposed on or embedded in the distal shoulder of the delivery device.

[0051] Figure 33 Another embodiment of an asymmetric radiopaque marker that allows a user to distinguish between two different locations of the marker within an imaging view is illustrated.

[0052] Figure 34A is an exemplary fluoroscopic image illustrating a guidewire extending through a distal portion of a delivery device and a device disposed on or embedded within a portion of the distal portion of the delivery device and in a first orientation relative to the guidewire. Figure 33 Asymmetric markings.

[0053] Figure 34B is an exemplary fluoroscopic image illustrating a guidewire extending through a distal portion of a delivery device and a second orientation disposed on or embedded within a portion of the distal portion of the delivery device. Figure 33 Asymmetric markings.

[0054] Figure 35A Illustrated are exemplary embodiments of radiopaque markers attached to commissures of a prosthetic valve, the prosthetic valve being in a radially compressed configuration.

[0055] Figure 35B The diagram shows the radially expanded configuration Figure 35A prosthetic valve.

[0056] Figure 35CAn exemplary prosthetic heart valve is illustrated having a first attachment member arranged across a cell of the prosthetic heart valve and secured to struts forming the cell, and a radiopaque marker secured to a second attachment member configured to attach to the struts forming the cell, wherein commissure tabs of adjacent leaflets of the prosthetic heart valve are secured to the first attachment member to form the commissure.

[0057] Figures 35D-35F Illustrated are a first attachment member and a second attachment member being simultaneously attached to struts forming a cell using the same suture.

[0058] Figure 35G The indicia of FIG. 35C are illustrated attached in front of the first attachment members of the commissures to second attachment members that are attached to struts of a unit forming a prosthetic valve.

[0059] Figure 35H The inner surfaces of the commissures and the first attachment member of the unit attached to the prosthetic valve are illustrated.

[0060] Figure 35I Illustrated are exemplary radiopaque markers configured to attach to commissures within a cell of a prosthetic valve.

[0061] Figure 35J Another exemplary embodiment of a radiopaque marker attached to a commissure within a cell of a prosthetic valve is illustrated.

[0062] Figure 35K Another exemplary embodiment of a radiopaque marker attached to a commissure within a cell of a prosthetic valve is illustrated.

[0063] Figure 35L Another exemplary embodiment of a radiopaque marker attached to a commissure within a cell of a prosthetic valve and a radiopaque marker attached to a skirt extending through the inner surface of the frame of the prosthetic valve just below the commissure is illustrated.

[0064] Figure 35M Another exemplary embodiment of a radiopaque marker attached to a commissure within a cell of a prosthetic valve is illustrated, the prosthetic valve being in a radially compressed configuration.

[0065] Figure 35N Another exemplary embodiment of a radiopaque marker attached to a commissure within a cell of a prosthetic valve is illustrated, the prosthetic valve being in a radially compressed configuration.

[0066] Figure 35O An exemplary embodiment of a radiopaque marker attached to a first attachment member that is attached to a second attachment member of a commissure within a cell of a prosthetic valve is illustrated.

[0067] Figure 35P Another exemplary embodiment of a radiopaque marker attached to a first attachment member that is attached to a second attachment member of a commissure within a cell of a prosthetic valve is illustrated.

[0068] Figure 36 An embodiment of an expandable balloon folded around a distal portion of a delivery device is illustrated.

[0069] Figure 37 is a cross-sectional view of an expandable balloon wrapped and folded around a portion of a delivery device at a valve mounting portion of the delivery device, according to an embodiment.

[0070] Figure 38 is a perspective view of an embodiment of a distal tip portion of an outer shaft for a delivery device, the distal tip portion including a plurality of helical internal expansion grooves.

[0071] Figure 39 is mounted on the distal end of the outer shaft and disposed over a portion of the inflatable balloon of the delivery device. Figure 38 Cross-sectional view of the distal tip portion of .

[0072] Figure 40 is a side view of the distal portion of the delivery device illustrating a radial depression in the distal portion of the expandable balloon of the delivery device when the distal tip portion is disposed away from the proximal portion of the balloon.

[0073] Figure 41 yes Figure 40 1 is a side view of a distal portion of a delivery device illustrating the state of the distal portion of the expandable balloon when the distal tip portion is disposed over the proximal portion of the balloon and a prosthetic valve is mounted on the valve mounting portion of the delivery device.

[0074] Figure 42 is a side view of a distal portion of an exemplary delivery device with a prosthetic valve mounted in a radially compressed state on and about a valve mounting portion of the distal portion of the delivery device, with selected commissures of the prosthetic valve circumferentially offset by a predetermined amount from radiopaque markers on the delivery device.

[0075] 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.

[0076] Figure 44 yes Figure 43 Front perspective view of the curling device.

[0077] Figure 45is a perspective view of an embodiment of a support body for a mounting assembly configured to mount and crimp a prosthetic valve onto a delivery device in a predetermined position and / or orientation relative to a delivery device, the support body being configured to maintain the prosthetic valve in a radially expanded state.

[0078] Figure 46 is a front perspective view of an embodiment of a ring body configured to couple to Figure 45 support body and circumferentially aligning the prosthetic valve on the support body in a desired orientation.

[0079] Figure 47 yes Figure 46 Rear perspective view of the ring body.

[0080] Figure 48 is with Figure 45 The support body is coupled to Figure 46 A perspective view of the ring body.

[0081] Figure 49 is a perspective view of an embodiment of a positioning device coupled to a mounting assembly of a distal portion of a delivery apparatus.

[0082] Figure 50 Is installed on Figure 45 End view of a prosthetic valve on a support body with the commissures and Figure 46 Align with the corresponding indicator on the ring body.

[0083] Figure 51 is a cross-sectional view of the mounting assembly, which includes Figure 45 The supporting body and Figure 49 The positioning device is coupled to Figure 43 The crimping device is configured to be disposed within the crimping device such that the prosthetic valve is disposed about the valve mounting portion of the distal portion of the delivery device in a predetermined orientation and / or position relative to the delivery device.

[0084] Figure 52 Is using Figure 43 Cross-sectional view of a prosthetic valve radially compressed onto a valve mounting portion of a delivery device after a crimping operation is performed by a crimping device.

[0085] Figure 53 is a perspective view of another embodiment of a positioning device that may be used in a mounting assembly and coupled to a crimping device.

[0086] Figure 54 is coupled to the distal portion of the delivery device proximal to the valve mounting portion Figure 53 Side view of the positioning device.

[0087] Figure 55 is coupled to Figure 54 The distal portion of the delivery device Figure 53 A perspective view of a positioning device.

[0088] Figure 56 is a flow chart of an exemplary method for crimping a prosthetic valve into a radially compressed state onto a distal portion of a delivery device at a predetermined position and a predetermined orientation relative to the delivery device.

[0089] Figure 57 is a flow chart of an exemplary method for implanting a prosthetic valve in place of a patient's native valve with one or more selected commissures of the prosthetic valve aligned with one or more corresponding commissures of the native valve.

[0090] Figure 58 An exemplary fluoroscopic image of the native valve viewed using a standard tricuspid valve imaging view is illustrated.

[0091] Figure 59 Illustrated are exemplary fluoroscopic images of a distal portion of a delivery device including an asymmetric radiopaque marker, wherein the marker is centered along a guidewire extending through the delivery device and appears in a forward-readable orientation, indicating that the marker is directly behind the imaging view.

[0092] Figure 60 is a schematic diagram illustrating a desired rotational positioning of a distal portion of a delivery device including a prosthetic valve mounted thereon at a native valve, wherein an asymmetric radiopaque marker of the delivery device is aligned with a target commissure of the native valve and a selected commissure of the prosthetic valve is circumferentially offset from the marker by a predetermined amount.

[0093] Figure 61 is a schematic diagram of an embodiment of a tricuspid valve imaging view of a native valve that can be used to visualize a delivery device in a patient's heart and rotationally align a prosthetic valve mounted on the delivery device during an implantation procedure.

[0094] Figure 62 is a cross-sectional view of the native valve, showing Figure 61 The location of the commissures of the native valve within the imaging view.

[0095] Figure 63 is a schematic diagram of an embodiment of a right / left cusp overlay imaging view of a native valve that can be used to visualize a delivery device in a patient's heart and rotationally align a prosthetic valve mounted on the delivery device during an implantation procedure.

[0096] Figure 64 is a cross-sectional view of the native valve, showing Figure 63 The location of the commissures of the native valve within the imaging view.

[0097] Figure 65 Illustrated is an embodiment of an alignment ring configured to rotationally align a prosthetic valve relative to a delivery device for an implantation procedure using a first imaging view.

[0098] Figure 66 Another embodiment of an alignment ring configured to rotationally align a prosthetic valve relative to a delivery device for an implantation procedure using a second imaging view is illustrated.

[0099] Figure 67 Another embodiment of an alignment ring including multiple sets of alignment marks for use in two or more implant procedures utilizing different selected imaging views is illustrated.

[0100] Figure 68 Another embodiment of an alignment ring comprising one or more sets of graduated alignment marks is illustrated.

[0101] Figure 69 is an exploded view of an embodiment of a balloon cover for a distal portion of a delivery device, the balloon cover being configured to cover an expandable balloon and a positioning device mounted on the distal portion.

[0102] Figure 70 yes Figure 60 A perspective view of a shell component of a balloon covering configured to cooperatively engage with another shell component of a balloon covering to form an outer shell of the balloon covering.

[0103] Figure 71A It includes elongated protrusions Figure 70 Detailed view of a portion of the mating edge of the housing member.

[0104] Figure 71B It includes elongated grooves Figure 70 A detailed view of another portion of the mating edge of the housing member.

[0105] Figure 71C When in the assembled configuration where the mating edges of the two housing members engage each other Figure 60 A detailed view of a portion of the mating interface between the two shell members of the balloon covering.

[0106] Figure 72 The figure is in an assembled configuration and with the components arranged inside and covered by the balloon cover shown with dotted lines. Figure 69 A first side view of a balloon covering.

[0107] Figure 73 Is in assembled configuration Figure 69A second side view of the balloon cover, wherein the second side view is from Figure 72 The first side view is rotated.

[0108] Figure 74 is from the proximal end of the balloon cover in the assembled configuration Figure 69 A perspective end view of the balloon covering.

[0109] Figure 75A Is in assembled configuration Figure 69 A perspective view of a balloon covering, wherein the portion of the balloon covering covering the positioning device has a wall including one or more windows configured to reduce the height of the balloon covering.

[0110] Figure 75B yes Figure 75A End view of the balloon covering.

[0111] Figure 75C yes Figure 75A Cross-sectional end view of the balloon covering.

[0112] Figure 76A is a perspective view of another embodiment of a balloon covering for a distal portion of a delivery device, the balloon covering being configured to cover an inflatable balloon and a positioning device mounted on the distal portion, wherein the portion of the balloon covering covering the positioning device has a wall that completely encloses the positioning device therein.

[0113] Figure 76B yes Figure 76A End view of the balloon covering.

[0114] Figure 77 is an exploded view of another embodiment of a balloon cover for a distal portion of a delivery device, the balloon cover being configured to cover an inflatable balloon and a positioning device mounted on the distal portion and to produce a specified final shape of the inflatable balloon.

[0115] Figure 78 yes Figure 77 A perspective view of a recessed sleeve of a balloon cover comprising one or more recessed members.

[0116] Figure 79 yes Figure 78 End view of the recessed sleeve.

[0117] Figure 80 yes Figure 78 Another perspective view of the recessed sleeve.

[0118] Figure 81A is in an unflexed or static configuration Figure 78 Cross-sectional side view of a recessed sleeve.

[0119] Figure 81B Is in a flexed or radially inward configuration Figure 78 Cross-sectional side view of a recessed sleeve.

[0120] Figure 82 is detached from the rest of the balloon covering Figure 77 A perspective view of the shell component of the balloon covering.

[0121] Figure 83A yes Figure 77 A first cross-sectional side view of the assembled balloon covering.

[0122] Figure 83B yes Figure 77 Second cross-sectional side view of the assembled balloon covering.

[0123] Figure 84 is a plan view of another exemplary embodiment of a shell member for a balloon covering configured to receive a portion of a distal portion of a delivery device including an expandable balloon and a positioning device mounted thereon, and to form a designated final shape of the balloon around the delivery device.

[0124] Figure 85 yes Figure 84 A perspective view of the housing components.

[0125] Figure 86 yes Figure 84 A cross-sectional side view of a housing member.

[0126] Figure 87A is a perspective view of a shaft connector release assembly coupling the proximal portion of a rotatable shaft of a delivery device to an adapter.

[0127] Figure 87B is the coupling of the proximal portion of the rotatable shaft to the adapter Figure 87A A cross-sectional view of the shaft connector release assembly.

[0128] Figure 88 yes Figure 87A Exploded view of the shaft connector release assembly, the proximal portion of the rotatable shaft, and the adapter.

[0129] Figure 89 Is a separate one in an assembled configuration Figure 87A A perspective view of the shaft connector release assembly.

[0130] Figure 90 yes Figure 89 Exploded view of the shaft connector release assembly.

[0131] Figure 91 yes Figure 89A perspective view of an embodiment of a release sleeve of a shaft connector release sleeve.

[0132] Figure 92 yes Figure 91 Side view of the release sleeve.

[0133] Figure 93 yes Figure 92 Cross-sectional side view of the release sleeve.

[0134] Figure 94 yes Figure 89 A perspective view of an embodiment of an adapter insert of a shaft connector release assembly.

[0135] Figure 95 yes Figure 94 Side view of the adapter insert.

[0136] Figure 96 yes Figure 95 Cross-sectional side view of the adapter insert.

[0137] Figure 97 An exemplary radiopaque marker is shown sutured to a central portion of an attachment member configured to form a commissure with commissure tabs of adjacent leaflets of a prosthetic heart valve and configured to be arranged across a cell of the prosthetic heart valve and secured to struts forming the cell.

[0138] Figure 98A Shown fixed to Figure 97 The attachment member includes a marking on an outer surface thereof and a commissure lug secured to an inner surface of the attachment member.

[0139] Figure 98B Shows the pillars attached to the unit Figure 98A The attachment member and the markings away from the joint.

[0140] Figure 99A Shown fixed to Figure 97 The attachment member includes a marking on an inner surface thereof and a commissure lug fixed to the inner surface of the attachment member.

[0141] Figure 99B Shows the pillars attached to the unit Figure 99B The attachment member and the marking facing the joint.

[0142] Figure 100 An exemplary embodiment is shown of a marker positioned against an elongated tab of an attachment member configured to form a commissure with commissure tabs of adjacent leaflets of a prosthetic heart valve and configured to be arranged across a cell of the prosthetic heart valve and secured to struts forming the cell.

[0143] Figures 101A-101EThe markings are shown sutured to the attachment member using one or more fasteners for securing the commissure tabs of the leaflets to the attachment member. Figure 100 The process of attaching components.

[0144] Figure 102 is a perspective view of another embodiment of a rotatable knob mounted on a proximal portion of a central shaft of a delivery device, the knob being configured to rotate the central shaft, thereby rotating an expandable balloon and a prosthetic heart valve radially compressed against the balloon.

[0145] Figure 103 yes Figure 102 Side view of the knob.

[0146] Figure 104 yes Figure 102 A first exploded view of the knob showing the two housing parts of the knob enclosing the anchor and the adapter.

[0147] Figure 105 yes Figure 102 Second exploded view of the knob.

[0148] Figure 106 yes Figure 102 A first cross-sectional side view of a knob showing the anchor and adapter inside the housing of the knob.

[0149] Figure 107 yes Figure 102 A second cross-sectional side view of the knob showing the alignment lugs of the anchor and adapter inside the housing of the knob.

[0150] Figure 108 is a perspective view of another embodiment of a balloon cover for a distal portion of a delivery device, the balloon cover being configured to cover an expandable balloon and a positioning device mounted on the distal portion.

[0151] Figure 109 yes Figure 108 Side view of the balloon covering.

[0152] Figure 110 yes Figure 108 Exploded view of the balloon cover.

[0153] Figure 111 yes Figure 108 Another side view of the balloon covering showing the sleeve covering a portion of the balloon covering for a potential radiopaque marking viewing window on the distal portion of the delivery device.

[0154] Figure 112 yes Figure 111Another side view of the balloon cover with the sleeve removed so that the viewing window and potential radiopaque markers on the distal portion of the delivery device are visible.

[0155] Figure 113 yes Figure 108 A cross-sectional perspective view of a balloon covering.

[0156] Figure 114 yes Figure 108 Partial cross-sectional side view of a balloon covering. DETAILED DESCRIPTION

[0157] General considerations

[0158] For the purposes of this description, certain aspects, advantages, and novel features of embodiments of the present disclosure are described herein. The methods, systems, and devices described herein should not be construed as limiting in any way. Rather, the present disclosure relates to all novel and non-obvious features and aspects of the various disclosed embodiments, individually and in various combinations and subcombinations thereof. The methods, systems, and devices of the present disclosure are not limited to any specific aspect, feature, or combination thereof, nor do the methods, systems, and devices of the present disclosure require that any one or more specific advantages exist or that any one or more specific problems be solved.

[0159] 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 features disclosed in this specification (including any accompanying claims, abstract, and drawings) and / or all steps of any method or process so disclosed may be combined in any combination, except for at least some mutually exclusive combinations of such features and / or steps. The present disclosure is not limited to the details of any foregoing embodiments. The present disclosure extends to any novel feature, or any novel combination of features, of the features disclosed in this specification (including any accompanying claims, abstract, and drawings), or to any novel step, or any novel combination of steps, of the steps of any method or process so disclosed.

[0160] Although some operations of the disclosed methods are described in a specific sequential order for ease of presentation, it should be understood that this description encompasses rearrangement unless a specific order is specified using specific terms below. For example, operations described sequentially may in some cases be rearranged or performed simultaneously. Furthermore, for the sake of brevity, the accompanying drawings may not illustrate the various ways in which the disclosed methods, systems, and apparatuses may be used in conjunction with other systems, methods, and apparatuses.

[0161] As used herein, the terms "a," "an," and "at least one" include one or more of the specified elements. That is, if two of a particular element are present, then one of those elements is also present, thus, there is "one" element. The terms "plurality" and "plurality" refer to two or more of the specified elements.

[0162] As used herein, the term "and / or" used between the last two of a list of elements means any one or more of the listed elements. 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."

[0163] As used herein, the term "coupled" generally means physically coupled or linked and does not exclude the presence of intervening elements between the coupled items absent specific language to the contrary.

[0164] Directional and other relative references (e.g., inside, outside, up, down, etc.) may be used to facilitate discussion of the figures and principles herein, but are not intended to be limiting. For example, certain terms such as "inside," "outside," "top," "downward," "inside," "outside," and the like may be used. When dealing with relative relationships, particularly with respect to the illustrated embodiments, such terms are used, where applicable, to provide some clarity to the description. However, such terms are not intended to imply absolute relationships, positions, and / or orientations. For example, with respect to an object, "up" can become "down" simply by turning the 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."

[0165] As used herein, with reference to prosthetic heart valves and delivery devices, "proximal" refers to a position, direction, or portion of a component that is closer to a user and / or a handle of a delivery device outside of a patient, while "distal" refers to a position, direction, or portion of a component that is further away from a user and / or the handle of a delivery device and closer to the implantation site. The terms "longitudinal" and "axial" refer to axes extending in proximal and distal directions, unless expressly limited otherwise. Additionally, the term "radial" refers to directions of points arranged perpendicular to an axis and along a radius from the center of an object (where the axis is located at the center, such as the longitudinal axis of a prosthetic valve).

[0166] Examples of the Disclosed Technology

[0167] Described herein are examples of prosthetic valve delivery apparatus and methods for delivering a radially expandable prosthetic valve and implanting it at a native valve of the heart such that the commissures of the prosthetic valve are circumferentially aligned within the commissures of the native valve.

[0168] Also described herein are examples of balloon coverings configured to receive a distal portion of a delivery device therein. In some embodiments, such balloon coverings can be configured to create a specified shape of an expandable balloon that covers a portion of the distal portion of the delivery device.

[0169] Also described herein are assemblies for coupling a rotatable shaft of a delivery device to an adapter of the delivery device, the adapter being configured to receive inflation fluid for an inflatable balloon of the delivery device.

[0170] In some embodiments, a delivery device may include a first shaft configured to rotate around a central longitudinal axis of the delivery device to rotationally align a prosthetic valve mounted on the delivery device with the native anatomical structure at a target implantation site. The delivery device may further include a second shaft extending through the first shaft and having a distal portion extending distally beyond the distal portion of the first shaft. In some embodiments, one or more polymer bodies (such as one or more balloon shoulders and / or nose cones) may be mounted on the distal portion of the second shaft. The delivery device may further include an inflatable balloon coupled to the distal portion of the first shaft. In some embodiments, a shoulder or another polymer body of the delivery device may be arranged within the balloon, and a radiopaque marker may be mounted on or embedded in the shoulder at a position radially spaced apart from the outer surface of the distal portion of the second shaft. The marker may be asymmetric in reflection along an axis parallel to the central longitudinal axis of the delivery device. The shoulder may 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 in an axial direction relative to the balloon.

[0171] In this manner, the delivery device 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 result in 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 marking on a shoulder of the delivery device or a surrogate polymer body is aligned with a desired landmark of the native anatomy and / or guidewire within a selected imaging view.

[0172] 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 on a delivery device in a radially compressed configuration during delivery and then expanded to a radially expanded configuration once the prosthetic valve reaches the implantation site. In some embodiments, the prosthetic valve can be deployed from a delivery device at an implantation site (e.g., a native heart valve) by inflating an inflatable balloon of the delivery device.

[0173] Figure 1 A prosthetic heart valve (e.g., a prosthetic valve) 10 is shown according to one embodiment. The illustrated prosthetic valve is adapted for implantation in the native aortic valve annulus, but in other embodiments it may be adapted for implantation in other native valve annuli of the heart (e.g., the pulmonary valve, mitral valve, and tricuspid valve). The prosthetic valve may also be adapted for implantation in other tubular organs or passageways in the body. The prosthetic valve 10 may 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 may have an inlet end portion 15, a middle portion 17, and an outlet end portion 19.

[0174] The valve structure 14 can include three leaflets 40 that together form a leaflet structure, which can be arranged to collapse in a tricuspid arrangement, although in other embodiments there can be a greater or fewer number of leaflets (e.g., one or more leaflets 40). The leaflets 40 can be secured to each other 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 fan-like shape and can be secured to the inner skirt 16 by sutures (not shown). In some embodiments, the leaflets 40 can be formed from pericardial tissue (e.g., bovine pericardial tissue), a biocompatible synthetic material, or various other suitable native or synthetic materials known in the art and described in U.S. Patent No. 6,730,118, which is incorporated herein by reference.

[0175] The frame 12 or its components (e.g., struts and / or fasteners) can be made of any of a variety of suitable plastically expandable materials (e.g., stainless steel, etc.) or self-expanding materials (e.g., nickel-titanium alloys (NiTi), such as Nitinol) as known in the art. When made of a plastically expandable material, the frame 12 (and therefore the prosthetic valve 10) can be curled to a radially collapsed configuration on a delivery catheter and then expanded inside the patient by an inflatable balloon or equivalent expansion mechanism. When made of a self-expandable material, the frame 12 (and therefore the prosthetic valve 10) can be curled to a radially collapsed configuration and constrained in a collapsed configuration by insertion into a sheath or equivalent mechanism of a delivery catheter. Once inside the body, the prosthetic valve can be advanced from the delivery sheath, which allows the prosthetic valve to expand to its functional size.

[0176] 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-chromium or nickel-cobalt-chromium alloys), polymers, or combinations thereof. In a specific embodiment, the frame 12 is made of a nickel-cobalt-chromium-molybdenum alloy, such as alloy (SPS Technologies, Jenkintown, Pennsylvania), which is equivalent to UNS R30035 alloy (covered by ASTM F562-02). By weight, Alloy / UNS R30035 alloy contains 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. WO2018 / 222799, which is incorporated herein by reference.

[0177] Figure 2A is a perspective view of a prosthetic heart valve 50 according to another embodiment. Prosthetic valve 50 may 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 prosthetic valve 50 , in which components on the outside of frame 52 , including sealing member 56 , are shown in transparent lines for illustrative purposes.

[0178] as Figure 1The flap-like structure 14 of the present invention may include three leaflets 60 that together form a leaflet structure that can be arranged to collapse in a tricuspid valve arrangement. Each leaflet 60 can be coupled to the frame 52 along its inflow edge 62 (the lower edge in the figure, also referred to as the "tip edge") and at a commissure 64 of the valve structure 54 where adjacent portions of the two leaflets are connected to each other (e.g., commissure tabs). In some embodiments, the commissure 64 can include an attachment member (e.g., comprising fabric, a flexible polymer, etc.) arranged across a unit (e.g., a commissure unit) of the frame 52 that is formed by struts of the frame. The attachment member can be fixed to the struts of the frame forming the unit, and adjacent portions of the two leaflets can be connected to the attachment member to form the commissure 64 (e.g., as Figure 16 and 17 as shown, as further described below).

[0179] Reinforcement elements (not shown), such as fabric straps, can be connected directly to the tip edges of the leaflets and the struts of the frame to couple the tip edges of the leaflets to the frame.

[0180] Similar to Figure 1 Frame 12, frame 52 can be made of any of a variety of suitable plastically expandable or self-expanding materials known in the art and described above. In the illustrated embodiment, frame 52 includes a plurality of circumferentially extending rows of inclined struts 72 that define rows of cells or openings 74 of the frame. Frame 52 can have a cylindrical or substantially cylindrical shape with 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.

[0181] The frame 52 may include a plurality of vertices 80 at each of the inlet end 66 and the outlet end 68 that are spaced apart from one another around the circumference of the frame 52 .

[0182] In the illustrated embodiment, the sealing member 56 is mounted on the outside of the frame 52 and is used to form a seal with the surrounding tissue (e.g., the native leaflets and / or the native annulus) to prevent or at least minimize paravalvular leakage. The sealing member 56 may include an inner layer 76 (which may be in contact with the outer surface of the frame 52) and an outer layer 78. The sealing member 56 may be connected to the frame 52 using a suitable technique or mechanism. For example, the sealing member 56 may be sutured to the frame 52 via sutures that may extend around the struts 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 outside of the frame 52.

[0183] 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. When the prosthetic valve is fully expanded outside the patient's body, the outer layer 78 can expand away from the inner layer 76 to create a space between the two layers. Thus, when implanted inside the body, this allows the outer layer 78 to expand into contact with the surrounding tissue.

[0184] Additional details regarding the prosthetic valve 50 and its various components are described in U.S. Patent Publication No. 2018 / 0028310, which is incorporated herein by reference.

[0185] Figure 3 A delivery device (e.g., apparatus) 100 is shown that can be used to implant an expandable prosthetic heart valve (e.g., prosthetic valve 10 or 50) or another type of expandable prosthetic medical device (such as a stent) according to an embodiment. In some embodiments, delivery device 100 is particularly suitable for introducing a prosthetic valve into the heart.

[0186] exist Figure 3 In the illustrated embodiment of the invention, the delivery device 100 is a balloon catheter that includes a handle 102, a steerable outer shaft 104 extending from the handle 102, an intermediate shaft extending coaxially from the handle 102 through the steerable outer shaft 104, and an inner shaft 106 extending coaxially from the handle 102 through the intermediate shaft and the steerable outer shaft 104, an inflatable balloon (e.g., a balloon) 108 extending from a distal end of the intermediate shaft, and a nose cone 110 disposed at the distal end of the delivery device 100. The distal portion 112 of the delivery device 100 includes the balloon 108, the nose cone 110, and a balloon shoulder assembly. A prosthetic medical device, such as a prosthetic heart valve, can be mounted on the valve retaining portion of the balloon 108, as described below with reference to Figure 9-11 , 41, and 42. As further described below, the balloon shoulder assembly is configured to maintain a prosthetic heart valve or other medical device in a fixed position on the balloon 108 during delivery through the patient's vasculature. In some embodiments, the balloon shoulder assembly can include a proximal shoulder 120 and / or a distal shoulder 122.

[0187] The handle 102 can include a steering mechanism configured to adjust the curvature of the distal 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 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 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 portion of the delivery device.

[0188] In some embodiments, the delivery device (or another similar delivery device) can be configured to deliver a prosthetic heart valve (e.g., Figure 1 Prosthetic valve 10 or Figure 2A and 2B The prosthetic heart valve 50) is deployed and implanted in the native aortic annulus of the native aortic valve. Figure 4 An exemplary heart 200 including an aortic valve 202 is shown in FIG. Figure 4 As shown, two coronary arteries (eg, a left coronary artery and a right coronary artery) 204 are coupled to an aorta 205 near the aortic valve 202 and branch off from the aorta 205. The coronary arteries 204 carry oxygenated blood from the aorta to the muscle of the heart 200.

[0189] like Figure 5A As shown, since the prosthetic heart valve 206 is implanted in the native aortic annulus of the aortic valve 202, blood flow 208 can leave the prosthetic heart valve 206, flow into the aorta 205, and then flow through the top of the outflow end of the prosthetic heart valve 206 and / or flow through the open cells in the frame of the prosthetic heart valve 206 (e.g., open cells that are not continuously covered by the leaflets of the prosthetic heart valve) to reach the coronary arteries 204 ( Figure 5A and 5B Depending on the patient's anatomy, the prosthetic heart valve may cover at least a portion of the opening of the coronary artery 204 (e.g., be positioned in front of it), such as Figure 5B When the commissures 210 of the prosthetic heart valve 206 are arranged 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 may be further exacerbated ( Figure 5B For example, because adjacent leaflets are coupled together at commissures 210, commissures 210 block and / or reduce blood flow through the cell to which they are coupled. Consequently, less oxygenated blood can reach the coronary arteries and heart muscle.

[0190] Thus, rather than deploying the prosthetic heart valve using a delivery device in a random rotational orientation relative to the aorta 205, which could result in the commissures 210 of the prosthetic heart valve 206 being positioned anterior to the coronary arteries 204 (e.g., Figure 6A ), but rather it may be desirable to position the commissures 210 away from and out of the way of the coronary arteries 204 (as shown). Figure 6B The prosthetic heart valve 206 is deployed in a target rotational orientation (as shown). Figure 6BAs shown, the delivery device can be configured to deploy the prosthetic heart valve 206 such that the commissures 210 of the radially expanded prosthetic heart valve 206 are circumferentially aligned with the native commissures 212 of the aortic valve 202 .

[0191] As explained further below, the delivery device can be configured to control the rotational positioning of the prosthetic heart valve 206 relative to the native valve to achieve Figure 6B The commissures shown in the example of aligning the prosthetic heart valve 204 are aligned, thereby increasing blood flow into the coronary arteries 204. In addition, such positioning of the prosthetic heart valve can facilitate later leaflet cutting procedures that provide increased blood flow to the coronary arteries, such as Figure 7-8B shown.

[0192] For example, Figure 7 As shown, the native leaflets 214 of a native valve (e.g., aortic valve 202) can be split (e.g., cut) longitudinally (relative to the central longitudinal axis of the prosthetic heart valve 206) at the entrance location of the coronary arteries 204. This enables increased blood flow from the aorta into the coronary arteries 204 through one or more open (e.g., not covered by leaflets) cells 216 of the prosthetic heart valve 206.

[0193] like Figure 8A As shown, the native leaflets 214 are split at the region between two adjacent commissures 210 of the frame of the prosthetic heart valve 206 (at Figure 8A and 8B 206), resulting in an open cell 216 that can receive blood flow therethrough. Figure 8B As shown, splitting the native leaflets 214 in the region of the frame of the prosthetic heart valve 206 that includes the commissures 210 (e.g., because the commissures 210 are positioned anterior to the entrances to the coronary arteries 204) does not result in the placement of the open cells 216 anterior to the entrances to the coronary arteries 204. Instead, the commissures 210 may continue to block blood flow to the coronary arteries 204.

[0194]

[0006] Therefore, it is desirable to have delivery devices and methods for deploying a radially expandable prosthetic heart valve in a desired rotational orientation relative to a native valve such that the prosthetic heart valve commissures are aligned with the native valve commissures.

[0195] Figure 9-68 Embodiments of a delivery device, method, and associated components for implanting a radially expandable prosthetic heart valve into a native valve using a delivery device such that the commissures of the prosthetic heart valve are aligned with the commissures of the native valve are illustrated. In some embodiments, the prosthetic valve and delivery device are configured such that the prosthetic valve is deployed from the delivery device at the native valve via inflation of a balloon of the delivery device.

[0196] Figure 9-14 FIGURE 1 illustrates a method for implanting an expandable prosthetic heart valve (e.g., Figure 1 Prosthetic valve 10 or Figures 2A-2B The invention relates to a delivery device 300 for a prosthetic valve 50 (e.g., a prosthetic heart valve 50) or another type of expandable prosthetic medical device (e.g., a stent). In some embodiments, the delivery device 300 is particularly suitable for introducing a prosthetic valve into the heart. As further described below, the delivery device 300 can be configured to rotate a prosthetic valve mounted on the delivery device in a radially compressed state at a target implantation site (e.g., at a native heart valve) to achieve alignment of the commissures between the native valve and the prosthetic valve after deployment of the prosthetic valve.

[0197] Similar to Figure 3 The delivery device 100 includes a handle 302 and a handle 302 ( Figure 9 and 14 ) a balloon catheter having a steerable outer shaft 304 extending distally from the delivery device 300. The delivery device 300 may further include a handle 302 ( Figure 9 and 14 ) and extends distally from the handle 302, and the portion extending distally from the handle 302 also coaxially extends through the outer shaft 304. In addition, the delivery device 300 may further include an inner shaft 308 that extends distally from the handle 302 and coaxially passes through the intermediate shaft 306 and the outer shaft 304 (e.g., Figure 13 355 in detail), and extends proximally from the handle 302, coaxially through the intermediate shaft 306.

[0198] As described further below, outer shaft 304 and intermediate shaft 306 are configured to translate longitudinally (eg, move) relative to each other along central longitudinal axis 320 to facilitate delivery and positioning of a prosthetic valve at an implantation site in a patient's body.

[0199] The intermediate shaft 306 may include a shaft extending proximally from the proximal end of the handle 302 to the adapter 312 ( Figure 9 and 14 ) of the proximal portion 310. A rotatable knob 314 can be mounted on the proximal portion 310 (FIGS. 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 below with reference to Figure 15-22 Further described.

[0200] The adapter 312 may 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 may be fluidly coupled to the inner lumen of the intermediate shaft 306, as further described below.

[0201] The intermediate shaft 306 can further include a distal portion 316 that extends distally beyond the outer shaft 304 when the distal end of the outer shaft 304 is positioned away from the inflatable balloon 318 of the delivery device. Figure 10 and 11) distal end (eg, as described below with reference to Figures 38-41 306. The distal end portion of the inner shaft 308 may extend distally beyond the intermediate shaft 306 ( Figure 10 )'s distal portion 316.

[0202] The balloon 318 is coupled to the distal portion 316 of the intermediate shaft 306. For example, in some embodiments, the proximal portion of the balloon 318 is coupled to and / or around the distal end 348 of the intermediate shaft 306. Figure 10 and 11 ).

[0203] The balloon 318 may include a distal portion (or section) 332 , a proximal portion (or section) 333 , and a middle portion (or section) 335 disposed between the distal portion 332 and the proximal portion 333 .

[0204] In some embodiments, the distal end of the distal portion 332 of the balloon 318 can be coupled to the distal end of the delivery device 300, such as to the nose cone 322 (e.g., Figure 9-11 ), or coupled to an alternative component (e.g., a distal shoulder) at the distal end of the delivery device 300. In some embodiments, the intermediate portion 335 of the balloon 318 can cover the valve mounting portion 324 of the distal portion 309 of the delivery device 300, the distal portion 332 can cover the distal shoulder 326 of the delivery device 300, and the proximal 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 capsule 318 can be configured to receive a prosthetic heart valve in a radially compressed state (e.g., as Figure 41 and 42 as shown, as further described below).

[0205] As described further below, rotation of intermediate shaft 306 results in rotation of balloon 318 and the prosthetic valve mounted thereon for rotational positioning of the prosthetic valve relative to the native anatomy at the target implantation site.

[0206] The balloon shoulder assembly is configured to maintain a prosthetic heart valve or other medical device in a fixed position on the balloon 318 during delivery through the patient's vasculature. The balloon shoulder assembly may include a distal shoulder 326 disposed within the distal portion of the balloon 318 and coupled to the distal portion of the inner shaft 308 ( Figure 9-11 The distal shoulder 326 can be configured to prevent a prosthetic valve or other medical device mounted on the valve mounting portion 324 from moving distally in an axial direction (eg, along the central longitudinal axis 320 ) relative to the balloon 318 .

[0207] For example, in some embodiments, the distal shoulder 326 may include a flared portion 331 ( Figure 10 In some embodiments, the flared portion 331 may include a distal shoulder 326 ( Figure 10 ) of the base (eg, shaft) portion 325 of the valve mounting portion 324 radially outwardly flared with a plurality of wings 330 (as described below with reference to Figure 28 、 32A -32B and 40-42 discussed in more detail).

[0208] The outer shaft 304 may include a distal tip portion 328 ( Figure 9 and 11 In some embodiments, the distal tip portion 328 can be configured as a flexure adapter comprising a plurality of inner and outer helical grooves, as described below with reference to Figures 38-41 As 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., Figure 41 328 ), the outer shaft 304 and the middle shaft 306 can be axially translated relative to each other to position the distal tip portion 328 adjacent the proximal end of the valve mounting portion 324. Thus, the distal tip portion 328 can be configured to prevent the proximal movement of the prosthetic valve relative to the balloon 318 in an axial direction when the distal tip portion 328 is disposed proximal to the valve mounting portion 324.

[0209] In some embodiments, the nose cone 322 can be disposed distal to and coupled to the distal shoulder 326. In some embodiments, the nose cone 322 can be coupled to a distal end portion of the inner shaft 308.

[0210] In some embodiments, the delivery device 300 can include one or more markers or marking bands 353 configured to indicate to a user the location of designated components of the delivery device. In some embodiments, the one or more marker bands 353 can be radiopaque. In some embodiments, the one or more marker bands 353 can be radially compressed (e.g., crimped) onto the inner shaft 308 ( Figure 10 and 11 And also Figure 32A and 40).

[0211] like Figure 10 As shown, the distal portion 332 of the balloon 318 may include a radial recess 334 that is recessed inwardly toward the central longitudinal axis 320 relative to the outermost radial surface of the distal shoulder 326 and the outermost radial surface of the nose cone 322. Figure 40 and 41 The radial recess 334 is described in further detail.

[0212] like Figure 13 The selected portion 355 of the delivery device 300 (from Figure 11 ), an annular space 336 can 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 can be referred to as an inner lumen of the intermediate shaft 306. In some embodiments, the annular space 336 can be configured to receive fluid from a fluid source via the 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 can be fluidically coupled to a fluid channel 342 ( Figure 10 ). Thus, fluid from the fluid source can flow from the annular space 336 to the fluid passage 342 to inflate the balloon 318 and radially expand and deploy the prosthetic valve.

[0213] Inner shaft 308( Figure 13 ) can be configured to receive a guidewire therethrough 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 a 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 Exemplary guidewires are shown in , 31A-31B, 34A-34B, and 59, as further described below.

[0214] like Figure 12 Schematic diagram of the intermediate shaft 306 and Figure 13The selected portion 355 of the delivery device 300 ( Figure 11 ), in some embodiments, the intermediate (e.g., balloon) shaft 306 can 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 can include a more rigid braided or coiled material, such as metal or polyethylene terephthalate (PET).

[0215] For example, the intermediate shaft 306 may be broken 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 can be a majority of the total length of the intermediate shaft 306. In some embodiments, the second length 358 can 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 can be approximately 6 inches. Thus, the first portion 346 can extend from the proximal portion 310 of the intermediate shaft 306 away from the distal end 348 of the intermediate shaft 306 by a distance (e.g., the second length 358).

[0216] The two layers of braided material of the intermediate shaft 306 may include a plurality of layers of braided material along 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 two layers of braided material of the intermediate shaft 306 may further include a second braided layer 352 that extends along the majority of the entire length of the intermediate shaft 306 along the first portion 346 ( FIG. 13 ). However, the second braided layer 352 stops before the second portion 354 ( FIG. 14 ). Figure 12 and 13 This may allow the distal second portion 354 of the intermediate shaft 306 to have increased flexibility at the distal end portion 316 .

[0217] In alternative embodiments, 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.

[0218] like Figure 9 and 14As shown, the handle 302 can include a steering mechanism configured to adjust the curvature of the distal portion 309 of the delivery device 300. In the illustrated embodiment, for example, the handle 102 includes an adjustment member, such as the illustrated rotatable knob 360, which in turn is operably coupled to a proximal portion of a pull wire. The pull wire can extend distally from the handle 302 through the outer shaft 304 and have a distal portion attached to the outer shaft 304 at or near the distal end of the outer shaft 304. Rotating the knob 360 can increase or decrease the tension in the pull wire, thereby adjusting the curvature of the distal portion 309 of the delivery device 300. Further details regarding steering or flexing mechanisms for delivery devices can be found in U.S. Patent No. 9,339,384, which is incorporated herein by reference.

[0219] The handle 302 may further include an adjustment mechanism 361 comprising an adjustment member (such as a rotatable knob 362 as shown) and a shaft 364 extending distally into a housing 366 of the handle 302. The adjustment mechanism 361 is configured to adjust the axial position of the intermediate shaft 306 relative to the outer shaft 304 ( Figure 9 and 14). In some embodiments, as Figure 14 As shown, an inner support 368 is mounted within a housing 366 on the intermediate shaft 306, and an inner shaft 370 (also referred to as a slider or sliding mechanism) is mounted on the inner support 368. The inner shaft 370 has a distal portion 372 formed with external threads that mate with internal threads extending along the inner surface of the shaft 364. The inner shaft 370 further includes a proximal portion 374 that mounts and interfaces with a locking mechanism 376 configured to maintain (e.g., lock) the position of the intermediate shaft 306 relative to the handle 302. The inner shaft 370 can be coupled to the inner support 368 such that rotation of the shaft 364 causes the inner shaft 370 to move axially within the handle 302. The locking mechanism 376 can include another adjustment member configured to receive a rotatable knob 378 of an internal nut 380 having internal threads that engage the external threads of the proximal portion 374 of the inner shaft 370.

[0220] To limit the movement of the intermediate shaft 306 for precise positioning of the prosthetic valve mounted on the distal portion of the delivery device 300, the knob 378 is rotated, which in turn causes the internal nut 380 to rotate. Consequently, the internal nut 380 translates in the distal direction along the external threads on the proximal portion 374 of the inner shaft 370. As the nut 380 moves distally, additional components of the locking mechanism 376 are configured to frictionally engage the intermediate shaft 306, thereby retaining the intermediate shaft 306 relative to the inner shaft 370. In the locked position, rotation of the knob 362 causes the inner shaft 370 and the intermediate shaft 306 to move axially relative to the outer shaft 304 (in the proximal or distal direction, depending on the direction in which the knob 362 is rotated).

[0221] Rotating the knob 378 in the opposite direction from the locked position to the unlocked position allows axial and rotational movement of the intermediate shaft relative to the inner shaft 370 and the proximal portion of the handle 302. Further details regarding the adjustment mechanism 361 and the locking mechanism 376 of the handle 302 can be found in U.S. Patent No. 9,339,384, which is incorporated herein by reference.

[0222] As described above, knob 314 of handle 302 can be configured to rotate intermediate (e.g., balloon) shaft 306, thereby rotating balloon 318 mounted to intermediate shaft 306 and the radially compressed prosthetic valve mounted on balloon 318 about valve mounting portion 324. Thus, rotating knob 314 can rotate the prosthetic valve about central longitudinal axis 320 to a desired orientation relative to the native anatomy at the target implantation site.

[0223] Figure 15-22 Various views are shown of an embodiment of a knob 314 configured to rotate the intermediate shaft 306 upon rotation of the knob 314. In alternative embodiments, a differently configured rotatable knob or other adjustment mechanism may be used in place of the knob 314 to rotate the intermediate shaft 306 of the delivery device 300.

[0224] like Figure 15 and 16 (and as mentioned above Figure 9 and 14 ), the knob 314 can be mounted on the proximal portion 310 of the intermediate shaft 306 at the distal end of the adapter 312. In some embodiments, the knob 314 can be directly coupled to a portion or the entirety of the adapter 312 and / or disposed around a portion or the entirety of the adapter 312 (e.g., as shown in FIG. Figures 102-107 In an alternative embodiment, the knob 314 may be axially spaced from the adapter 312 .

[0225] The knob 314 may include an outer housing 382 (eg, housing one or more internal components of the knob 314) disposed about (eg, housing one or more internal components of) the knob 314. Figure 15-17 and 20). 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 extending outwardly from an outer surface of the outer housing 382 and spaced apart from one another around the 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.

[0226] In some embodiments, to increase the ease of assembly of the knob 314, the outer shell 382 can be divided into two or more mating parts. For example, in some embodiments, as shown in FIG. Figure 15 、 16 20, the outer housing 382 can 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 can include corresponding mating interfaces configured to couple the first housing portion 384 and the second housing portion 385 to each other. In this manner, the first housing portion 384 and the second housing portion 385 can be coupled to each other around the intermediate shaft 306 and the internal components of the knob 314, thereby forming the knob (e.g., knob assembly) 314.

[0227] The knob 314 can further include an anchor 386 disposed within the outer housing 382 and configured to anchor (eg, couple) the knob 314 to the proximal end portion 310 (eg, the intermediate shaft 306) of the intermediate shaft 306. Figure 17-19 ). Figure 19 A cross-sectional view of the knob 314 is shown with the anchor 386 coupled to the intermediate shaft 306 and the outer housing 382 coupled about the anchor 386 . Figure 18 and 19 A cross-sectional view and a perspective view of the anchor 386 are shown, respectively.

[0228] like Figure 17-19 As shown, the anchor 386 can include a shaft portion 387 defining an inner lumen 388 configured to receive and couple around the intermediate shaft 306. In some embodiments, the inner lumen 388 has a relatively constant inner diameter.

[0229] In some embodiments, the distal end of the shaft portion 387 may include one or more radial extensions 389 ( Figure 17-19 ). In some embodiments, one or more or each of radial extensions 389 can extend around the entire circumference of shaft portion 387. In some embodiments, one or more radial extensions 389 can be configured as annular barbs that are axially spaced apart from one another.

[0230] The one or more radial extensions 389 may be configured to mate with the interior of a sleeve element (which may also be referred to as a strain relief element) 391 ( Figure 17 In some embodiments, the sleeve member 391 can be disposed about a portion of the proximal portion 310 of the intermediate shaft 306, and the outer housing 382 can include a wider first aperture 392 configured to receive and / or clamp around the proximal end of the sleeve member 391 therein. Figure 15-17 ). The sleeve element 391 can be configured to relieve strain between the knob and the proximal portion of the second shaft. In some embodiments, the sleeve element 391 can include a flexible and / or elastic material, such as an elastic polymer material (e.g., rubber).

[0231] The outer housing 382 may further include a narrower second aperture (eg, channel) 393 configured to receive the distal portion (eg, the distal end) of the adapter 312. Figure 17 and 20 ).

[0232] like Figure 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 with) corresponding channels or holes 395 disposed in the outer shell 382 ( Figure 17 and 20 ). The extension portions 394 can be spaced apart from each other and extend radially outward from the shaft portion 387 of the anchor 386.

[0233] In some embodiments, as Figure 17-19 As shown, the anchor 386 can include two extensions 394 extending from each of two opposing sides of the anchor 386. However, in alternative embodiments, the anchor 386 can include more or less than four extensions 394. The number of holes 395 can be the same as the number of extensions 394.

[0234] In some embodiments, the mating portions of the aperture 395 and the corresponding extension 394 can have a hexagonal shape. However, in alternative embodiments, other shapes are possible, such as rectangular, square, etc.

[0235] In some embodiments, the anchor 386 can be configured for bonding (e.g., UV bonding) to the outer surface of the intermediate shaft 306. For example, in some embodiments, the shaft portion 387 of the anchor 386 can include one or more centering ribs 396 (e.g., spaced about the circumference of the inner lumen 388 and extending along the inner lumen 388). Figure 18 and 19 In some embodiments, the shaft portion 387 can include a viewing aperture 397 (eg, configured as a window) that can allow a user to observe the alignment and / or engagement between the anchor 386 and the intermediate shaft 306 ( Figure 18 and 19 ). For example, Figure 17 As shown, the aperture 397 can extend between the outer and inner surfaces of the shaft portion 387 and be disposed in a central portion of the shaft portion 387. In some embodiments, the proximal portion of the shaft portion 387 of the anchor 386 can include a counterbore 398 (FIGS. 17 and 18). The counterbore 398 can provide an enhanced UV bond between the anchor 386 and the intermediate shaft 306.

[0236] The knob 314 may also include an alignment lug or extension 399 ( Figure 21-22 ), which is configured to align the adapter 312 with a radiopaque marker (e.g., Figure 28 The mark 500 shown, Figures 32A-32B The mark 600 or Figure 33 In some embodiments, as shown in FIG. Figure 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 shaft portion 387 of the anchor 386 in a direction that is arranged perpendicular to the direction in which the extension portion 394 extends radially outward from the shaft 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 so that they extend outward in relatively the same direction relative to the central longitudinal axis 320 (e.g., both point outward from the same side of the intermediate shaft 306, as shown). Figure 21 and 22 shown).

[0237] In some embodiments, the knob 314 can be assembled to the proximal portion 310 of the intermediate (eg, 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 possible.

[0238] 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 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 marker on the distal portion 309 points upward (e.g., away from the table, which would appear to be a truncated or unfixed object). Figure 21 ), and the anchor 386 can be positioned so that the alignment lug 399 points away from the user (e.g., a person assembling the device), as shown Figure 21 For example, in Figure 21 After this portion of the alignment is complete, the anchor 386 can be bonded to the intermediate shaft 306 (e.g., via UV bonding), and the sleeve element 391 can then be positioned over the radial extension 389 of the anchor 386.

[0239] In some embodiments, the assembly method may further include coupling the adapter 312 to the intermediate shaft 306 such that the second port 340 points in the same direction as the alignment tab 399 and / or the second port 340 and the alignment tab 399 are circumferentially aligned relative to the circumference of the intermediate shaft 306. Figure 21 and 22 ). In this way, during the implantation procedure, the user can know the initial (e.g., starting) position of the radiopaque marker on the distal portion 309 of the delivery device 300 within the patient. This can enable easier and faster rotational positioning of the radiopaque marker, and therefore the prosthetic valve, at the target implantation site, as further described below.

[0240] The outer shell 382 can then be positioned around the anchor 386 ( Figure 22 In some embodiments, this may include positioning the first housing portion 384 and the second housing portion 385 around the anchor 386 and coupling them to each other.

[0241] Figures 102-107 Various views of another embodiment of a knob (or handle) 2500 are shown that is configured to rotate the intermediate shaft 306 of the delivery device 300 when the knob 2500 is rotated. The knob 2500 (which may also be referred to as a handle or valve rotation control (VRC)) can be similar in function 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 is configured to include or enclose an adapter (such as or similar to the adapter 312). Thus, in one embodiment, Figure 9 The delivery device 300 includes knob 2500 instead of knob 314.

[0242] Respectively as Figure 102 and 103 As shown in the perspective and side views of FIG, the knob 2500 can be mounted on the proximal portion 310 of the intermediate shaft 306 and surround or include the adapter 312 (or another similar adapter) therein. Figures 102 to 107 As shown, the knob 2500 is disposed about and encloses the adapter 312 such that a user cannot grasp or rotate the adapter 312 independently of the knob 2500 .

[0243] In some embodiments, the outer housing 2502 may 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 Figures 102-107 As shown, one or more grasping elements 2504 can be raised elements or features extending radially outward from the outer surface of outer shell 2502 and spaced apart from one another around the circumference of outer shell 2502. In alternative embodiments, one or more grasping elements 2504 can be raised ridges and / or recessed indentations in outer shell 2502.

[0244] In some embodiments, to increase the ease of assembly of the knob 2500, the outer shell 2502 can be divided into two or more mating parts. For example, in some embodiments, as shown in FIG. Figure 103 as well as Figure 104 105, the outer housing 2502 can include a first housing portion 2506 and a second housing portion 2508 configured to be removably coupled to each other. For example, each of the first housing portion 2506 and the second housing portion 2508 can include corresponding mating interfaces configured to couple the first housing portion 2506 and the second housing portion 2508 to each other. In this manner, the first housing portion 2506 and the second housing portion 2508 can be coupled to each other around the intermediate shaft 306 and the internal components of the knob 2500, thereby forming the knob (e.g., knob assembly) 2500.

[0245] Similar to Figure 15-22 The knob 2500 may include an anchor 386 (e.g., a member 386 disposed within the outer housing 2502 and configured to anchor (e.g., couple) the knob 2500 to the proximal portion 310 of the intermediate shaft 306. Figure 106 and 107 For example, 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 FIG. Figure 15-22described (and Figure 106 and 107 shown).

[0246] As above reference Figure 15-22 As described, the housing 1502 is configured to couple around and to the anchor 386 and to receive the sleeve member 391 and / or clamp around the proximal end of the sleeve member 391. For example, similar to the outer housing 382 of the knob 314, the outer housing 2502 may include a first aperture 2510 (formed by the two halves of the outer housing 2502 when the two halves are coupled together) that is configured to receive the proximal end of the sleeve member 391 therein and / or clamp around the proximal end of the sleeve member 391 (Figs. 104-107).

[0247] The outer housing 2502 may further include an inner cavity 2512 (at its proximal end) configured to receive the adapter 312 ( Figures 104-107 The outer housing 2502 may include a second aperture 2514 (formed by the two halves of the outer housing 2502 when the two halves are coupled together) that is configured to fit around the first port 338 of the adapter 312 ( Figures 104-107 ). The proximal end of the first port 338 can extend proximally 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 ( Figure 102 , 103, 106 and 107).

[0248] The outer shell 2502 can further include an extension portion 2556 that extends outward at an angle from the main body of the outer shell 2502. A portion of the inner cavity 2512 can be formed within the extension portion 2556 and configured to receive the second port 340 of the adapter 312. In some embodiments, the extension portion 2556 can include a third hole 2558 (formed by the two halves of the outer shell 2502 when the two halves are coupled together) that is configured to fit around the second portion 340 ( Figure 104 and 107 The open end of the second port 340 may extend outward and away from the third hole 2558 .

[0249] In an alternative embodiment, rather than receiving the adapter 312 within the inner cavity 2512, the adapter and outer housing 2502 may be integrated together (eg, formed or molded as one piece).

[0250] Similar to the reference above Figure 15-22 314, the outer housing 2502 of the knob 2500 may include one or more holes 395 disposed on the interior of the outer housing 2502 and configured to receive and mate with one or more extensions 394 of the anchor 386. Figures 104-106 In some embodiments, each hole 395 can be disposed in a radially extending member 2520 extending from the inner surface of the outer shell 2502 ( Figures 104-106 ).

[0251] In some embodiments, as described above with reference to Figure 21-22 As depicted, the anchor 386 may include an alignment lug 399 ( Figure 104 and 107 ). As described above and as Figure 104 and 107 As shown, during assembly, the alignment lugs 399 can be aligned with the second port 340 of the adapter 312 so that they extend outwardly in relatively the same direction relative to the central longitudinal axis 320 (e.g., both point outwardly from the same side of the intermediate shaft 306, as shown in FIG. Figure 104 and 107 shown).

[0252] In some embodiments, the knob 2500 can be assembled to 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 FIG. Figure 15-22 Descriptive.

[0253] 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 adjacent to the sleeve element 391 on and around the intermediate shaft 306. 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 marking on the distal portion 309 points upward (e.g., away from the table), and the anchor 386 can be positioned such that the alignment lug 399 points away from the user. After this portion of alignment is complete, the anchor 386 can be bonded to the intermediate shaft 306 (e.g., via UV bonding), and the sleeve element 391 can then be positioned over the radial extension 389 of the anchor 386.

[0254] In some embodiments, the assembly method can further include coupling the adapter 312 to the intermediate shaft 306 such that the second port 340 points in the same direction as the alignment tab 399, and / or the second port 340 and the alignment tab 399 are circumferentially aligned relative to the circumference of the intermediate shaft 306. In this manner, during the implantation procedure, the user can know the initial (e.g., starting) position of the radiopaque marker on the distal portion 309 of the delivery device 300 within the patient. This can enable easier and faster rotational positioning of the radiopaque marker, and therefore the prosthetic valve, at the target implantation site, as further described below.

[0255] The outer shell 2502 can then be positioned around the anchor 386 and the adapter 312 ( Figures 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 additional fasteners.

[0256] In some embodiments, the outer shell 2502 can include one or more indicators 2522 (e.g., markings) that indicate to the user which way the knob 2500 should be rotated in order to align a radiopaque marker on the distal portion of the delivery device (e.g., marker 500 or any other marking described herein) with a guidewire traveling 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" marking as shown), and arrows on either side of the line that indicate to the user which way to rotate the knob 2500 if the radiopaque marker does not appear aligned with the guidewire in a selected imaging view during the implantation procedure, as further described herein (e.g., during the method at 1308, as described below with reference to FIG. ). Figure 57 description).

[0257] For example, if a radiopaque marker (e.g., marker 600 or another marker described herein) on the distal portion of the delivery device appears on a first side of the guidewire in a fluoroscopic imaging view, the user can rotate knob 2500 in a first direction (as indicated by a first arrow of indicator 2522), and if the radiopaque marker appears on an opposite second side of the guidewire in the imaging view, the user can rotate knob 2500 in an opposite second direction (as indicated by a second arrow of indicator 2522) to position the marker in alignment with the guidewire during the implantation procedure. In some embodiments, as Figure 102 and 103 As shown, each of the first housing portion 2506 and the second housing portion 2508 can include an indicator 2522 , and two indicators 2522 (one on each housing portion) can be arranged 180 degrees apart from each other around the knob 2500 .

[0258] In some embodiments, the presence of knob 314 or knob 2500 for rotating intermediate shaft 306 to achieve the desired rotational positioning of the prosthetic valve at the target implantation site can reduce the likelihood that a user will grasp and use adapter 312 to rotate intermediate shaft 306 and the prosthetic valve. Such forces or torques applied to adapter 312 may cause damage to adapter 312. Additionally, by completely enclosing or surrounding adapter 312 within knob 2500, as in Figures 102-107 As shown, the user is prevented from grasping the adapter 312 and applying torque to the adapter 312 .

[0259] In some embodiments, to further prevent a user from grasping and rotating the adapter 312 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 .

[0260] For example, Figure 23-27 An embodiment of a proximal portion 400 of a delivery device is shown that includes an adapter 402 that includes a first port 404 and a second (eg, expansion) port 406 that is configured to rotate. In some embodiments, the proximal portion 400 can be used as Figure 9 and 14 The proximal portion of the delivery device 300. In addition, in some embodiments, the proximal portion 400 may include the same Figure 9 and similar components to those described in 14, and therefore in Figure 23 are marked similarly in .

[0261] like Figure 23 As shown, the proximal portion 400 may include a handle (e.g., a handle portion), such as described above with reference to Figure 9and 14 The handle 302 is described. However, in alternative embodiments, alternative handle configurations are possible. A rotatable shaft (such as an intermediate (e.g., balloon) shaft 306) may extend distally from the handle 302 (e.g., Figure 9 and 14 ), and having a proximal portion 310 ( Figure 23 ). In addition, a rotatable knob 414 can be mounted on the proximal portion 310 of the intermediate shaft 306 at the distal end of the adapter 402. The knob 414 can be configured to rotate the intermediate shaft 306. In some embodiments, the knob 414 can be as described above with reference to Figure 15-22 Knob 314 is described.

[0262] The adapter 402 can further include an adapter body (eg, main body) 408. The adapter body 408 can be coupled (eg, connected) to the proximal end portion 310 (eg, Figure 23 and 26 For example, the adapter body 408 may include a proximal end portion configured to receive the intermediate shaft 306 therein ( Figure 26 ) of the first internal channel 410 ( Figure 25 ).

[0263] In some embodiments, an additional adapter 442 may be disposed about the intermediate shaft 306 between the knob 414 and the adapter body 408 ( Figure 23 and 26 ).

[0264] The first port 404 may extend axially from the adapter body 408 ( Figures 24-26 In some embodiments, the first port 404 can be directly and / or rigidly coupled to a proximal portion 412 of the adapter body 408 that defines a second internal passage 416 of the adapter body 408 ( Figure 25-27 For example, in some embodiments, the first port 404 and the proximal portion 412 can be joined together at a joint 444 (eg, via welding or an adhesive). Figure 25 ).

[0265] In some embodiments, the first port 404 can be configured as a guidewire port adapted to receive a guidewire. For example, in some embodiments, a guidewire can be inserted into the opening 418 in the first port 404 and extend through the inner shaft 308, which is received within and extends through the second inner passage 416 and the first inner passage 410. For example, Figure 26 and 27As shown, the proximal end of the inner shaft 308 can be disposed and engaged within the distal passage 420 of the first port 404 ( Figure 25-27 ). A guidewire may then be inserted into opening 418 and extended through the inner lumen defined by inner shaft 308.

[0266] The second port 406 can extend radially outward from the adapter body 408 in a direction that intersects the central longitudinal axis 422 of the adapter 402 and the central longitudinal axis of the delivery device (eg, central longitudinal axis 320). Figure 25 In some embodiments, the second port 406 can extend radially outward from the adapter body 408 at an angle between 10 and 90 degrees to the central longitudinal axis 422. In some embodiments, the second port 406 can extend radially outward from the adapter body 408 in a direction perpendicular to the central longitudinal axis 422.

[0267] The second port 406 is rotatably coupled to the adapter body 408. For example, Figure 25-27 As shown, the second port 406 can be rotatably coupled to the proximal portion 412 of the adapter body 408. In some embodiments, the second port 406 can include a base portion 424 disposed about the proximal portion 412 of the adapter body 408.

[0268] A seal 426 may be disposed between the base portion 424 and the proximal portion 412 of the adapter body 408 ( Figure 25-27 In some embodiments, the seal 426 can be a circumferential or annular seal that extends around the outer surface (eg, around the 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 quad seals.

[0269] 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 connected to the shaft portion 430. The shaft portion 430 can extend radially outward from one side of the base portion 424.

[0270] The proximal portion 412 of the adapter body 408 can include an annular groove 434 that defines an annular channel 436 (best seen in Figures 25 and 27) that extends around at least a portion of the circumference of the proximal portion 412 of the adapter body 408. In some embodiments, the annular channel 436 can fluidly couple the internal passage 432 to an annular space 438 defined between the outer surface of the inner shaft 308 and the inner surface of the proximal portion 412 of the adapter body 408. Figure 26 and27 ).

[0271] In some embodiments, one or more holes 440 extending radially inward from the annular groove 434 can fluidly connect the annular space 438 with the internal passage 432 ( Figure 25 and 27 ). The annular space 438 can be fluidly coupled to the annular space 336 defined between the outer surface of the inner shaft 308 and the inner surface of the intermediate shaft 306 ( Figure 26 In alternative embodiments, the annular groove 434 may extend through the thickness of the proximal portion 412 of the adapter body 408 to fluidly couple the internal passage 432 with the annular space 438 .

[0272] In this manner, fluid (e.g., inflation fluid) can flow from the interior passageway 432 to the annular space 438, to the annular space 336, and into the inflatable balloon (e.g., as described above with reference to Figure 9-14 4 (e.g., the balloon 318 described above) while allowing the second port 406 to rotate about the adapter body 408 (e.g., about the central longitudinal axis 422). Thus, a user may be prevented from attempting to rotate the intermediate shaft 306 by rotating the adapter 402 (e.g., because doing so may cause the second port 406 to rotate about the adapter body 408). Additionally, rotating the second port 406 may prevent torque from being applied to the adapter body 408 and the first port 404, thereby increasing the durability and life of the adapter 402 and preventing the coupling 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., balloon 318) by injecting inflation fluid through the second port 406 may be increased. Furthermore, having a rotatable second port 406 may allow a user to position the second port 406 in a variety of positions (for injecting inflation fluid) without causing unnecessary movement of the delivery device.

[0273] As referenced above Figure 9-27 As described, delivery device 300 and / or similarly configured delivery devices may include one or more features that facilitate rotational alignment of a radially compressed prosthetic valve disposed on a distal portion of the delivery device at a target implantation site.

[0274] As mentioned above, it may be desirable to utilize a delivery device such as Figure 9-14The delivery device 300) implants the prosthetic heart valve into the native valve such that the commissures of the prosthetic heart valve are aligned with the commissures of the native valve. In some embodiments, to facilitate desired rotational positioning of the prosthetic heart valve relative to the native valve, a radiopaque marker visible under medical imaging can be disposed on or embedded in a portion of a distal portion of the delivery device (such as a polymeric body mounted on a distal portion of a shaft) that is disposed in the vicinity of a valve mounting portion (e.g., valve mounting portion 324) of the delivery device and thereby radially compressed prosthetic valve. As further described below, in some embodiments, the radiopaque marker can be configured to be positioned in a manner that allows the prosthetic heart valve ... Figure 9-11 The position of selected commissures of the prosthetic valve is indicated after the balloon 318 of the prosthetic valve is inflated to radially expand the prosthetic valve.

[0275] Figure 28-34B The device is shown arranged on a delivery device such as Figure 9-14 An embodiment of a radiopaque marker on or embedded in a portion of a delivery device 300 is shown. Figure 28 、 29 32A-32B, but in alternative embodiments, the radiopaque marker can be disposed on or embedded within a portion of 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 marker is disposed or embedded can be a polymeric body mounted on a shaft at a distal portion of the delivery device. For example, the polymeric body can be a proximal shoulder, a distal shoulder (e.g., Figure 9-11 ) or a nose cone mounted to the inner shaft of a delivery device (e.g., Figure 9-11 One or more of the nose cone 322 in the body, and / or another polymer body mounted to the inner shaft.

[0276] Figure 28 The device is shown positioned on a delivery device (e.g., Figure 28 and 29 300) as shown in FIG. Figure 28 As shown, the distal shoulder 326 of the distal portion 309 of the delivery device 300 can include a marker 500 disposed thereon and / or embedded therein.

[0277] like Figure 28 As shown and referenced above Figure 9-11As explained, the inflatable balloon 318 is disposed over (e.g., covers) the distal shoulder 326 and the valve mounting portion 324. The nose cone 322 is disposed at the distal end of the delivery device 300 and is disposed proximal to (and distal to) the distal shoulder 326. As described above, the valve mounting portion 324 is configured to receive a radially compressed prosthetic valve thereon about 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 an axial direction (which is disposed along and relative to the central longitudinal axis 320 of the delivery device 300).

[0278] The nose cone 322 and / or the distal shoulder 326 can comprise one or more polymeric materials and, therefore, can be referred to herein as a polymer body. In some embodiments, the distal portion 309 of the delivery device 300 can have an additional polymer body or component, such as a proximal shoulder disposed on a side of the valve mounting portion 324 opposite the distal shoulder 326.

[0279] The marker 500 can be configured to be visible under medical imaging. For example, the marker 500 can 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, the marker 500 can include a radiopaque or other material configured to be visible under MRI, ultrasound, and / or echocardiography. The polymer body (such as the distal shoulder 326) on which the marker 500 is disposed and / or embedded can be configured so that it is not radiopaque. Thus, the marker 500 can be more easily visible under imaging, as described below with reference to Figure 29 Further described.

[0280] Although the mark 500 Figure 28 309 of the delivery device, but in alternative embodiments, the marker 500 may be disposed on and / or embedded in another polymeric 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 nose cone 322 or the proximal shoulder of the delivery device (e.g., Figure 3 The proximal shoulder 120 shown is positioned on and / or embedded in the proximal shoulder 120).

[0281] The marking 500 may have various shapes or patterns. For example, although the marking 500 may be Figure 28 and 29500 is shown as a dot, but in alternative embodiments, the mark 500 can be configured as a different shape or symbol, such as a circle, rectangle, star, square, triangle, "X", etc. Figure 30-34B Further embodiments of the shape of the marker are described.

[0282] like Figure 28 As shown, marker 500 is disposed on and / or embedded within a portion of distal shoulder 326. In some embodiments, the portion of distal shoulder 326 on which marker 500 is disposed may be a portion of distal shoulder 326 that is positioned closer to (e.g., adjacent to) valve mounting portion 324 than the remainder of distal shoulder 326. Thus, when a radially compressed prosthetic valve is disposed on valve mounting portion 324, marker 500 may be disposed proximate to and adjacent to the prosthetic valve.

[0283] In some embodiments, as Figure 28 As shown, the distal shoulder 326 can include a base portion 325 and a flared portion 331. The flared portion 331 can extend radially outward from the base portion 325 toward the valve mounting portion 324. The marking 500 can be disposed on and / or embedded in the flared portion 331 such that the marking 500 is oriented radially outward from the outer surface of the inner shaft 308. In alternative embodiments, the marking 500 can be disposed on and / or embedded in the base portion 325.

[0284] In some embodiments, as Figure 28 As shown, the flared portion 331 may include a plurality of wings 330 (which may also be referred to as extensions) extending radially outward from the base portion 325 at an angle relative to the central longitudinal axis 320. The wings 330 may be spaced apart from one another around the circumference of the flared portion 331. Figure 28 As shown, 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.

[0285] In some embodiments, the marker 500 can be a single (eg, only) radiopaque marker disposed on the distal shoulder 326. In some embodiments, the marker 500 can be a only (or single) radiopaque marker disposed on the distal portion 309 of the delivery device 300.

[0286] In some embodiments, the distal portion 309 of the delivery device 300 can include additional radiopaque markers (in addition to the marker 500).

[0287] Placing the marker 500 on or in the distal shoulder 326 or another polymer body of the distal portion of the delivery device can allow the marker 500 to be more visible under imaging (such as fluoroscopy) because the remainder of the distal shoulder 326 can be less or non-radiopaque and, therefore, less or not visible in fluoroscopic images. For example, Figure 29 As shown in exemplary fluoroscopic image 550 of FIG, marker 500 is visible and prominent under fluoroscopy because the distal shoulder is not radiopaque (except for marker 500). In contrast, the prosthetic valve frame 552 is radiopaque and visible under imaging. Therefore, radiopaque markers positioned on and / or in the prosthetic valve itself may be more difficult to see under imaging because the valve frame appears relatively dark in image 550.

[0288] Also like Figure 29 As shown, a guidewire 554 extending through the center of the distal portion 309 of the delivery device (e.g., through the inner lumen of the inner shaft 308) is visible under fluoroscopy, and the marker 500 is positioned radially outward from the guidewire 554 (e.g., due to the marker 500 being positioned on the flared portion 331 of the distal shoulder 326). This further increases the visibility of the marker 500 under imaging during the implantation procedure. Additionally, as further described below, when the marker 500 is positioned directly behind or in front of the imaging view, the marker 500 can appear to overlap with the guidewire.

[0289] Additionally, positioning the marker 500 on or in the distal shoulder 326 (or another polymeric body of the distal portion of the delivery device) can allow for more accurate alignment with the commissures of the native valve. For example, as further described below, it may be desirable to rotationally align the marker 500 with the target commissures of the native valve prior to passing through the leaflets of the native valve. Thus, when rotating the distal portion 309 of the delivery device (including the distal shoulder 326 and the prosthetic valve) to align the marker 500 with the target commissures of the native valve, it may be advantageous to position the marker 500 as far as possible on the delivery device so that it is positioned as close as possible to the target commissures of the native valve. Figure 28 As shown, the distal shoulder 326 (and nose cone 322) is one of the distal-most components of the delivery device 300 and is disposed more distally than the radially compressed prosthetic valve (e.g., more distally than the valve mounting portion 324, as shown). Figure 28 (as seen in ).

[0290] Positioning the marker 500 on or in the distal shoulder 326 (or another polymeric body of the delivery device positioned to be offset in the axial direction from the prosthetic valve) also allows the marker 500 to be offset in the circumferential direction from the selected commissures of the prosthetic valve. For example, as described further below, as the prosthetic valve rotates upon inflation of the inflatable balloon 318, the marker 500 can be offset in the circumferential direction from the selected commissures of the prosthetic valve to compensate for this rotation. Thus, after deployment of the prosthetic valve, the selected commissures of the prosthetic valve can be aligned with the target commissures of the native valve. If the prosthetic valve itself had an offset marker, this could be confusing after valve deployment because the marker would be visible but would not actually mark the selected commissures of the prosthetic valve.

[0291] Furthermore, 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 a relatively permanent implant (e.g., a 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 (e.g., due to valve testing as a result of any design modifications to the prosthetic valve) than if the marker 500 were on the valve.

[0292] 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, including the marker 500 and the radially compressed prosthetic valve (e.g., frame 552), relative to the surrounding native anatomy. Based on prior knowledge of the location of selected commissures of the native valve (where the prosthetic valve is to be implanted) within the selected imaging view, the user can rotationally align the distal portion of the delivery device at the target implantation site such that the marker 500 is aligned with the known location of the selected commissures in the selected imaging view, or such that the marker 500 is positioned in a specific location (e.g., directly posterior) within the selected imaging view and deploying the prosthetic valve in this orientation will result in alignment of the commissures between the prosthetic valve and the native valve.

[0293] For example, in some imaging views, selected commissures of the native valve may be positioned directly behind the imaging view. Thus, by aligning the marker 500 on the delivery device with the directly behind the imaging view, the prosthetic valve may be implanted within the native valve with the commissures between the native valve and the prosthetic valve aligned. Figure 58 、 61 Exemplary fluoroscopic imaging views obtained during a prosthetic valve implantation procedure and used to guide a delivery device close to a native valve are shown in 63, as further described below.

[0294] In order to achieve the desired positioning of the marker within the selected imaging view, in some embodiments, the marker can be configured as an asymmetric marker, which is then aligned with the 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., the front and back of the imaging view) can be more easily discerned.

[0295] Figure 30-34B Example embodiments of such asymmetric markers that allow a user to distinguish between two different locations of a marker within an imaging view are shown. For example, in some embodiments, the asymmetric marker is configured so that a user observing an imaging view can distinguish whether the marker is positioned in front of or behind the fluoroscopic imaging view. Figure 30-34B The markings shown may be positioned on the delivery device as described above with reference to Figure 28 and 29. For example, in some embodiments, Figure 30-34B The markings shown may be substituted for the distal shoulder 326 of the distal portion 309 of the delivery device or for the markings 500 ( Figure 28 and 29).

[0296] In some embodiments, the asymmetric indicia can be letters of the alphabet that are reflected asymmetrically along an axis parallel to the central longitudinal axis of the delivery device (e.g., Figure 30-34B As shown), numbers, symbols, shapes, etc. For example, an asymmetrical indicia can have a first orientation in which it can be read "correctly" or forward (e.g., not backward), and a second orientation rotated approximately 180 degrees about an axis from the first orientation, which causes the indicia to appear backward to a reader (e.g., a user).

[0297] Figure 30 is shown shaped as the letter "C" and can be used with Figure 28 The first exemplary embodiment of the asymmetric marker 600 is similarly configured to the marker 500 (e.g., radiopaque). The C-shaped asymmetric marker 600 is reflectively asymmetric across the longitudinal axis 602 and, when positioned on a delivery device (e.g., delivery device 300), as described above with reference to FIG. Figure 28 As depicted, the C-shaped asymmetric marker 600 is parallel to the central longitudinal axis of the delivery device. Figure 30In the embodiment of the present invention, the C-shaped asymmetric marker 600 is in a first orientation, which is its orientation in which it can be read forward (e.g., it appears to the reader in its correct, rather than backward, orientation). If the C-shaped asymmetric marker 600 is rotated approximately 180 degrees about its longitudinal axis 602, the C-shaped asymmetric marker 600 will be in a second orientation, and the "C" will appear backward (e.g., flipped). These two orientations of the C-shaped asymmetric marker 600 can be seen in medical imaging views (e.g., using fluoroscopy), as further explained herein. The two orientations of the C-shaped asymmetric marker (and other asymmetric markers described herein) can be mirror images of each other.

[0298] Figure 31A and 31B A guidewire 606 extending through a distal portion of the delivery device (e.g., distal portion 309 of delivery device 300) and a portion disposed at the distal portion of the delivery device (e.g., distal shoulder 326, as shown in FIG. Figure 28 Exemplary fluoroscopic images 610 and 612 of a C-shaped asymmetric marker 600 on or embedded in FIG. Figure 31A As shown in the first fluoroscopic image 610 of FIG. 6 , the C-shaped asymmetric marker 600 is aligned with (e.g., overlaps) the guidewire 606, and the "C" is readable in its first (forward) orientation. In some embodiments, Figure 31A This position of the marker 600 shown may indicate that the marker 600 is positioned behind the guidewire 606 within the first fluoroscopic imaging view 610 and, therefore, directly behind the imaging view. Figure 31A The position of the marker shown may indicate that the marker is positioned in front of the guidewire 606 and, therefore, directly in front of the imaging view.

[0299] In contrast, when the delivery device is Figure 31A When its orientation as shown is rotated approximately 180 degrees, the C-shaped asymmetric mark 600 is correspondingly rotated and appears in its second (rearward) orientation, wherein the "C" is rearward, as shown. Figure 31B In some embodiments, Figure 31B The position of the marker 600 shown may indicate that the marker 600 is disposed in front of the guidewire 606 within the imaging view, and therefore directly in front of the imaging view. Figure 31B The position of the marker 600 shown may indicate that the marker is positioned behind the guidewire 606 and, therefore, directly behind the imaging view.

[0300] In this manner, by observing the orientation of a 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., near the target native valve) can be more easily and quickly determined. Figures 57-60 Further details are explained regarding rotationally aligning the markers relative to the guidewire so that the prosthetic valve is implanted with the commissures aligned with the commissures of the native valve.

[0301] Figure 32A and 32B Side and perspective views, respectively, illustrate exemplary positioning of an asymmetric marker 600 (shaped as the letter "C") on and / or embedded within the distal shoulder 326 of the distal portion 309 of the delivery device 300. Figure 32A and 32B As shown, the marker 600 can be positioned on the distal shoulder 326 (e.g., in some embodiments, on the wing 330) so that when the delivery device is deployed within the patient's vasculature, and similar to Figure 29 The longitudinal imaging view of the image 550 in FIG. 1 is used to visualize the delivery device. 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.

[0302] In an alternative embodiment, the marking 600 may be on the distal shoulder. Figure 32A and 32B The illustration is oriented differently such that the marker 600 is rotated 180 degrees and is instead read in a forward orientation when the marker 600 is directly in front of the imaging view.

[0303] Figure 33-34B is shown shaped as the letter "E" and can be used with Figure 28 A second exemplary embodiment of an asymmetric marker 650 is similarly configured to the marker 500 (eg, radiopaque). Figure 33 The E-shaped asymmetric mark 650 is shown alone, while Figure 34A and 34B Fluoroscopic images of an E-shaped asymmetric marker 650 are shown in two different orientations relative to the guidewire 606 on the delivery device.

[0304] Aside from its overall shape (e.g., E-shaped rather than C-shaped), the E-shaped asymmetric marker 650 may be similar to the markers described above with reference to FIG. Figure 30-32B The described marker 600 is similarly configured and functions.For example, an E-shaped asymmetric marker 650 can reflect asymmetry across a longitudinal axis 652 that, when positioned on a delivery device, is parallel to a central longitudinal axis of the delivery device.

[0305] Similar to indicia 600, E-shaped asymmetric indicia 650 has a first orientation that is its forward (or "correct") readable orientation (e.g., Figure 33 and 34A 654). The E-shaped asymmetric mark 650 also has a second orientation that is rotated approximately 180 degrees from the first orientation about its longitudinal axis 652. In the second orientation, the "E" appears backward (as shown in FIG. Figure 34B These two orientations of the E-shaped asymmetric marker 650 can be seen using medical imaging (e.g., fluoroscopy), as shown in the second image 656. Figure 34A and 34B As shown and further explained in this article.

[0306] In some embodiments, the E-shaped asymmetric mark 650 may replace Figure 32A and 32B Indicia 600 is shown on a delivery device.

[0307] In other embodiments, the asymmetric mark can be formed as another letter (other than "C" or "E", such as "P" or "F"), number, symbol, shape, etc. that is reflectively asymmetric as described above and has two distinguishable orientations when rotated approximately 180 degrees about its reflectively asymmetric axis.

[0308] In some embodiments, an asymmetric marker (eg, marker 600 or marker 650) disposed on or embedded within a distal portion of a delivery device, such as distal shoulder 326, can comprise a radiopaque material. In some embodiments, the radiopaque material comprises metal.

[0309] 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.

[0310] In some embodiments, the asymmetric markings described herein may comprise a platinum-iridium alloy. In some embodiments, the platinum-iridium alloy has an alloy ratio of 90:10. In some embodiments, the platinum-iridium alloy has an alloy ratio in the range of 75:25 to 95:5. In some embodiments, the platinum-iridium alloy has an alloy ratio in the range of 85:15 to 95:5.

[0311] In some embodiments, instead of or in addition to being positioned on the distal portion of the delivery device, a radiopaque marker can be positioned on the prosthetic valve, such as on or near the commissures of the prosthetic valve, e.g. Figures 35A-35PThus, the locations of selected commissures of a radially compressed prosthetic valve can be identified by medical imaging during a valve implantation procedure and rotationally aligned with the native anatomy at the target implantation site.

[0312] In embodiments where radiopaque markers are provided on a distal portion of the delivery device (as described above) and on the prosthetic valve (at or near the commissures, as described below), a first radiopaque marker on the delivery device can be visualized during the valve implantation procedure to rotationally align the first marker with the native anatomy and deploy the prosthetic valve so that its commissures are aligned with the commissures of the native valve. A second radiopaque marker on the prosthetic valve can then be visualized after implantation (e.g., during a future intervention to locate the prosthetic valve commissures and / or confirm the position of the prosthetic valve commissures relative to the native valve commissures). In some embodiments, the second radiopaque marker at the commissures of the prosthetic valve can be more easily visualized after radial expansion of the prosthetic valve (after implantation).

[0313] exist Figure 35A and 35B Attached to a prosthetic valve 704 (which may be similar to any of the prosthetic valves described herein, such as Figure 1 Prosthetic valve 10 or Figure 2A and 2B 1. An exemplary embodiment of a radiopaque marker 700 of a commissure 702 of a prosthetic valve 50). Figure 35A The prosthetic valve 704 is shown in a radially compressed configuration (eg, state), such as when it is deployed around and crimped onto a delivery device, and Figure 35B Prosthetic valve 704 is shown in a radially expanded configuration (eg, state).

[0314] As referenced above Figure 2A and 2B As introduced and Figure 35A and 35B As shown, in some embodiments, the commissures 702 of the prosthetic valve 704 can include attachment members 706 arranged across cells (e.g., commissure cells) 708 of a frame 710 of the prosthetic valve 704. In some embodiments, the attachment members can include fabric, a flexible polymer, etc. arranged on the cells 708. As explained herein, the cells 708 can be formed by struts 712 of the frame 710. The attachment members 706 can be arranged across the cells 708 and secured to the struts 712 of the frame 710 forming the cells 708 via fasteners 714 (e.g., sutures). Additionally, adjacent portions of two leaflets 716 of the prosthetic valve 704 can be connected to the attachment members 706 to form the commissures 702.

[0315] In some embodiments, the commissure tabs of two adjacent leaflets 716 are located on the inner surface of the attachment member 706 ( Figure 35E 706, and the marker 700 is disposed on an outer surface 724 of the attachment member 706. The inner surface can be disposed opposite the outer surface 724, facing the interior of the prosthetic valve 704.

[0316] In some embodiments, as Figure 35A and 35B As shown, the marker 700 can be disposed on a central region of the commissure unit 708. For example, in some embodiments, the marker 700 can be sutured to a central region of the attachment member 706 via one or more fasteners (eg, sutures) 722.

[0317] In some embodiments, the marker 700 can be shaped and positioned so that it fits within the cell 708 when the frame 710 is in the radially compressed configuration, as shown in FIG. Figure 35A shown.

[0318] In some embodiments, commissure cells 708 may be disposed at an outflow end 718 of the prosthetic valve 704 .

[0319] In some embodiments, marker 700 comprises tantalum or another radiopaque material described herein or known in the art, formed or laser cut into a shape that reflects asymmetry across an axis, similar to that described above with reference to Figure 28-34B Descriptive.

[0320] In some embodiments, the prosthetic valve 704 includes a skirt 720 disposed around the frame 710 of the prosthetic valve 704 at the inlet end (eg, the end disposed opposite the outlet end 718) of the prosthetic valve 704. Figure 35B ).like Figure 35A and 35B As shown, when the commissure cells 708 are disposed at the outflow end 718 of the prosthetic valve 704 , the commissure cells 708 , including the markers 700 , may be spaced apart from the skirt 720 in the axial direction.

[0321] Figures 35C-35H Another exemplary embodiment of attaching radiopaque markers 750 to commissures within cells 708 of a prosthetic valve is shown. Figures 35C-35H The prosthetic valve shown can be Figure 35A The same prosthetic valve as the prosthetic valve 704 shown in FIG35B and thus Figures 35C-35H are marked accordingly. However, in Figures 35C-35HIn FIG, there are two attachment members arranged across the cell 708 and attached to the struts 712 that form the cell 708. The commissure tabs 754 and the markers 750 of the leaflets 716 may be sutured to different ones of the two attachment members.

[0322] For example, the attachment member 706 to which the commissure tabs 754 of the leaflet 716 are attached can be the first attachment member 706 ( Figure 35C 、 35D and 35H), and the marker 750 may be attached to the second attachment member 752 ( Figures 35C-35G ).

[0323] Marker 750 can be similar to marker 700 and other radiopaque markers described herein. For example, marker 750 can be configured (eg, shaped and sized) such that when frame 710 is in a radially compressed configuration (eg, as Figure 35A As shown), marker 750 fits within unit 708.

[0324] exist Figure 35I An exemplary embodiment of a marker 750 is shown in FIG. The marker 750 can be oval in shape, having a first (upper) hole 726 and a second (lower) hole 728 configured to receive a fastener (e.g., a suture) for securing the marker 750 to an attachment member, as further described below. In some embodiments, the marker can include more or less than two holes (e.g., one, three, four, etc.) for receiving fasteners. In some embodiments, the marker 750 can have a different shape configured to fit within the cell 708 when the frame 710 is radially compressed, such as one of the other marker shapes and embodiments described herein (e.g., reference Figure 35A 、 35B and 35J-35P).

[0325] In some embodiments, the indicia 750 may be shaped as letters of the alphabet (e.g., Figure 35A and 35B).

[0326] In some embodiments, the marker 750 may be reflective asymmetrically across an axis parallel to the central longitudinal axis 760 of the frame 710 (e.g., as Figure 35A and 35B shown).

[0327] like Figure 35C As shown, the first attachment member 706 can be secured to the struts 712 forming the cell 708 via fasteners (e.g., sutures) 714. The commissure tabs 754 of two adjacent leaflets 716 can be coupled to the first attachment member 706 at its inner surface 756, as shown. Figure 35HAs shown (joint lug 754 through Figure 35C 755 in FIG. 7 ). For example, the commissure tabs 754 can be sewn directly to the inner surface 756 of the first attachment member 706 or via one or more intervening fabric layers therebetween.

[0328] Also like Figure 35C As shown, the marker 750 may extend through the marker 750 ( Figure 35I ) is secured to the second attachment member 752 by one or more fasteners 758 (e.g., sutures) through the first and second holes 726, 728 in the second attachment member 752. In some embodiments, the marker 750 can be sutured to a central region of the second attachment member 752 using the fasteners 758.

[0329] In other embodiments, the flag 750 can have another number of holes or a different shape configured to receive the fastener 758 for securing the flag 750 to the second attachment member 752. For example, in some embodiments, the flag 750 can be annular (e.g., shaped as the letter "O").

[0330] Figure 35C The indicia 750 is shown attached to the second attachment member 752 but before the second attachment member 752 is assembled to the frame 710 . Figure 35G 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 is sutured to the struts of the frame using one or more sutures 762. Figure 35C and 35G The opposite side of the second attachment member 752 is shown in FIG.

[0331] In some embodiments, as Figure 35G As shown, the second attachment member 752 can be arranged relative to the frame 710 such that the exposed metal material of the flag 750 faces the frame 710 and the outer surface 724 of the first attachment member 706 .

[0332] Thus, when the second attachment member 752 is arranged across the cell 708 and attached to the struts 712 forming the cell 708, as shown in FIG. Figure 35G As shown, the marker 750 can be sandwiched (eg, disposed) between the second attachment member 752 and the first attachment member 706 .

[0333] In some embodiments, the second attachment member 752 can include a similar or identical fabric material as the first attachment member 706 .

[0334] In some embodiments, the second attachment member 752 can be secured to the strut 712 via additional fasteners, such as sutures.

[0335] In other embodiments, Figures 35D-35F As shown, the second attachment member 752 and the first attachment member 706 can be secured to the struts 712 simultaneously and using the same fasteners (e.g., sutures 762). For example, in some embodiments, after securing the commissure tabs 754 of two adjacent leaflets 716 to the first attachment member, the top portion of the first attachment member 706 can initially be secured to the upper struts 712 of the cell 708 using first sutures 762a. Figure 35D ). The second attachment member 752 having the indicia 750 fixed thereto can then be aligned with the first attachment member 706 ( Figure 35D 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 struts 712 on the first side of the cell 708 ( Figures 35D-35G ), thereby forming a single load-bearing suture from the top to the bottom of the cell 708. Similarly, the second suture 762b can pass through both the first attachment member 706 and the second attachment member 752 and around the struts 712 on the second side of the cell 708 (Figures 35E-35G), thereby forming another single load-bearing suture from the top to the bottom of the cell 708.

[0336] In this manner, the second attachment member 752 is disposed outside the first attachment member 706 relative to the outer surface of the frame 710 and the central longitudinal axis 760 of the frame 710 ( Figure 35C ). Thus, any metal-on-frame contact between the marker 750 and the frame 710 and / or any abrasive contact between the marker 750 and the outside (e.g., outer surface) of the frame 710 can be avoided. Additionally, by securing the marker 750 to the outer second attachment member 752, contact between the marker 750 and the leaflet (which is secured to the inner first attachment member 706) is also avoided.

[0337] In some embodiments, the markers 750 can be secured to the struts 712 using a suture pattern that avoids the tissue of the leaflets 716. In some embodiments, the additional material provided by the second attachment member 752 can also protect the tails and sutures used to secure the commissure tabs 754 to the first attachment member 706, making the commissures stronger and more durable.

[0338] As described above, due to its positioning on the frame 710 and its radiopaque nature, the marker 750 can provide identification (e.g., visibility) of the commissures during the implantation process, thereby achieving desired commissure alignment, as described herein. Additionally, such radiopaque markers 750 can also provide identification of the location of the commissures of the prosthetic valve after implantation and during any future interventional procedures.

[0339] Figures 35J-35P Additional embodiments of radiopaque markers are shown that are configured to be attached to commissures within cells 708 of a prosthetic valve, to additional attachment members (which are then attached to cells 708), or to additional skirt or fabric material just below the location of the commissures (e.g., as in FIG. Figure 35L For example, in some embodiments, Figures 35J-35P Any of the markings shown may replace marking 700 on prosthetic valve 704 ( Figures 35A-35B ) or the marking 750 on the second attachment member 752 ( Figure 35C -H). In addition, Figures 35A-35P Any markings shown may be attached to the additional skirt or fabric material (e.g., Figure 35L shown).

[0340] Figures 35J-35P The exemplary markers shown have different shapes or configurations. In some embodiments, the shape of the marker and / or the mounting position on the valve can be selected based on the geometry and spatial constraints of the valve (e.g., the size of the cells of the frame). In some embodiments, when the frame 710 of the prosthetic valve is in its radially compressed and radially expanded configurations, Figures 35J-35P One or more of the illustrated markers may be shaped and sized to fit within cell 708 .

[0341] Figure 35J An exemplary embodiment of a radiopaque marker 766 is shown secured to an attachment member 706 disposed across cells 708 of a frame 710 using one or more fasteners (e.g., sutures) 768. Figure 35J As shown, the markers 766 are arcuate with their longest dimension arranged in the circumferential direction (e.g., across the width of the cell 708). However, in alternative embodiments, the markers 766 may be oriented differently within the cell 708, such as with their longest dimension arranged in the axial direction (e.g., as shown in FIG. Figure 35L as shown and described below).

[0342] Figure 35KAn exemplary embodiment of a radiopaque marker 770 is shown secured to an attachment member 706 arranged across cells 708 of a frame 710 using one or more fasteners (e.g., sutures) 772. The marker 770 is annular or "o" shaped. For example, the marker 770 can include a central hole 771, and one or more fasteners 772 can extend through the central hole 771, around the marker 770, and through the material of the attachment member 706. In some embodiments, the marker 770 can be centered on the attachment member 706.

[0343] Figure 35L An exemplary embodiment of a radiopaque marker 774 and a radiopaque marker 776 are shown, with the radiopaque marker 774 being secured to an attachment member 706 disposed across the cell 708 of the frame 710 using one or more fasteners (e.g., sutures) 775 and the radiopaque marker 776 being secured to one or more skirts 778 extending across the inner surface of the frame 710 using one or more fasteners (e.g., sutures) 780. In some embodiments, the one or more skirts 778 can include a plurality of skirts 778, each skirt 778 being secured to the tip edge of a corresponding leaflet 716 and folded over to extend across the struts 712 of the frame 710 disposed between the tip edges of adjacent leaflets 716. Thus, in some embodiments, the marker 776 can be secured to an overlapping portion 782 of two adjacent skirts 778 that is disposed axially below the commissures 702. In certain embodiments, the prosthetic valve 704 can have only one of the markers 774 and 776 secured to the frame 710. As shown in FIG. Figure 35L , markers 774 and 776 are arranged to extend in the direction of central longitudinal axis 760 of frame 710 of prosthetic valve 704 (e.g., the longest dimensions of markers 774 and 776 extend in an axial direction relative to central longitudinal axis 760). Marker 774 can be the same as or similar to marker 776 shown in FIG35J , but rotated so that its longest dimension extends in the axial direction.

[0344] Marks 766, 770, 774 and 776 ( Figures 35J-35L ) can each include one or more mounting holes 784 configured to receive one or more fasteners (e.g., fasteners 768, 772, 775, or 780) for securing a marker to the attachment member 706 or one or more skirts 778. As shown in Figures 35J-35L, 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 smaller than the width of the marker).

[0345] Figures 35M-35PA further exemplary embodiment is shown that reflects asymmetric radiopaque markers along an axis parallel to the central longitudinal axis of the frame 710 of the prosthetic valve 704. Thus, Figures 35M-35P The markings shown can provide an indication of the position of the commissures 702 relative to the guidewire under fluoroscopic imaging (as explained herein).

[0346] For example, Figure 35M An exemplary embodiment of a radiopaque marker 786 is shown secured to an attachment member 706 disposed across a cell 708 of a frame 710 using one or more fasteners (e.g., sutures) 787. 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. Because the solid material portion 791 and the hole 789 are disposed on opposite sides of the marker 786 relative to the axis 790, the marker 786 is reflectively asymmetric across the axis 790.

[0347] Figure 35N Another exemplary embodiment of a radiopaque marker 792 is shown secured to an attachment member 706 disposed across cells 708 of a frame 710 using one or more fasteners (e.g., sutures) 787 and configured similarly to marker 786 ( Figure 35M 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 solid material portion 791 of the marker 792 are shaped differently than the marker 786 (e.g., further elongated).

[0348] In some embodiments, the markers described above can be affixed to the attachment member 706, to a region of the leaflet, or to tissue of the leaflet (e.g., the commissure tabs 754 of the leaflet 716, as shown). Figure 35H ). For example, the inferior commissure tabs of the leaflets 716 of the commissure 702 are represented in the figure as the more heavily cross-hatched central region on the attachment member 706. In some embodiments, the marker can be configured to attach to the attachment member 706 outside of this tissue region, thereby avoiding the need to place additional fasteners or sutures into the tissue of the commissure tabs of the leaflets.

[0349] Figure 35O and 35PAn exemplary embodiment of a radiopaque marker is shown that is secured to an additional attachment member (which may be a fabric, for example), and the additional attachment member is then secured to the attachment member 706 externally of the underlying tissue region 799. For example, Figure 35O An exemplary embodiment of a radiopaque marker 794 is shown secured to an additional attachment member 793 by one or more fasteners (e.g., sutures) 797, which can extend through a central hole (or cutout area) 795 in the marker 794. The additional attachment member 793 can be secured directly to the attachment member 706 externally to the tissue region 799 by one or more fasteners (e.g., sutures) 796. Thus, the marker 794 can be secured to the attachment member 706 by the additional attachment member 793 without the need to secure the marker 794 itself directly to the attachment member 706.

[0350] Similarly, Figure 35P Another exemplary embodiment of a radiopaque marker 794 is shown secured to an additional attachment member 798 by one or more fasteners (e.g., sutures) 797 that may extend through a central hole (or cutout area) 795 in the marker 794. The additional attachment member 798 may then be secured directly to the attachment member 706 by one or more fasteners 796. Figure 35O and 35P As shown, the further attachment member 798 has a diamond shape, while the further attachment member 793 has a rectangular shape. Alternative shapes for the further attachment members are possible (e.g., circular, square, etc.).

[0351] exist Figure 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 the commissure tabs of two adjacent leaflets (thereby forming the commissures) and to secure to the struts 712 of the cells 708 of the frame 710 of a prosthetic heart valve, such as Figure 35A and 35B shown.

[0352] Figures 97-99B An embodiment is shown in which a radiopaque marker 750 is attached (eg, sutured) directly to the attachment member 730. Figure 97As shown, the attachment member 730 can include first and second side portions 732a, 732b that project laterally from a central portion 734 (or central region). The attachment member 730 can further include an upper lug 736 and a lower lug 738 that project from the upper and lower edges, respectively, of the central portion 734. Further details regarding attachment members for securing commissure lugs of adjacent leaflets to a frame of a prosthetic valve are described in U.S. Patent Publication No. 2018 / 0028310, which is incorporated herein by reference.

[0353] like Figure 97 As shown, the marker 750 is secured directly to the central portion 734 of the attachment member 730 by one or more sutures 740 (with one or more knots formed on the outside of the marker 750). The attachment member 730 can then be folded and secured to the commissure tabs of the leaflet so that the marker 750 is disposed on a radially outwardly facing surface 742 (e.g., facing away from the leaflet) of the attachment member 730. 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 tabs 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 interior of the leaflet and 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 ). Therefore, if Figure 99A and 99B As shown, the indicia 750 is disposed behind the attachment member 730 .

[0354] Figure 100-101E Another embodiment is shown in which a radiopaque marker 750 is attached (e.g., sutured) to an elongated tab 744 (or extension) of an attachment member 746. Figure 100 As shown, the attachment member 746 is similar to Figure 97 Attachment member 730 is similar to that of FIG. 1 , except that it includes longer tabs 744 extending from center portion 734 (instead of shorter upper lugs 736). Figure 101A As shown in FIG. 8 , the marker 750 may be attached to the flap 744 and the joint formed with the attachment member 746 (such as a Figure 32A and 32B35H ), the sutures (or other similar fasteners) are used to secure the commissure tabs of adjacent leaflets to the attachment member 746 (such as shown in FIG. 35H ).

[0355] For example, the indicia 750 may be placed on the first surface 748 of the flap 744 ( Figure 100 , which shows the marking 750 as transparent for illustration purposes), over one or more holes in the fin 744. Figure 100-101E In an embodiment, the wing 744 includes two holes, including a first hole 701 and a second hole 703 that can be spaced apart based on the spacing between the first hole 726 and the second hole 728 of the marking 750 (for example, such that the first hole 726 overlaps with the first hole 701 and the second hole 728 overlaps with the second hole 703).

[0356] The flaps 744 can then be folded over the outer surface 705 of the central portion 734 of the connecting member 746, over the sutures extending outwardly from the outer surface 705 that connect the commissure tabs of the adjacent leaflets to the connecting member 746 ( Figure 101A Thus, the indicia 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 ).

[0357] The first suture 709 can then be advanced through the second hole 728 of the marker 750 and through the second hole 703 in the flap 744 so that they extend outwardly and away from the second surface 707 of the flap 744 ( Figure 101B Similarly, the second suture 711 can be advanced through the first aperture 726 of the marker 750 and through the first aperture 701 in the flap 744 such that they extend outwardly and away from the second surface 707 of the flap 744 ( Figure 101B ).

[0358] In some embodiments, the free end of the first suture 709 can be passed through the looped portion 713 of the first suture 709, which is disposed on each side of the flap 744, below the flap 744 ( Figure 101C ). Then, the first suture 709 is tightened against the flap 744, as shown in FIG. Figure 101D shown.

[0359] The free (loose) ends of the first suture 709 can then be tied (or knotted) together to separate the first portion ( Figures 101A-101EThe top portion of the marker 750 in the figure is secured to the attachment member 746, and the free (loose) end of each second suture 711 can then be tied (or knotted) together with the corresponding third suture 717 (of a pair of third sutures 717 arranged below the flap 744) to secure the second (e.g., bottom) portion of the marker 750 to the attachment member 746 (Figure 101E).

[0360] In some embodiments, the first suture 709 can be tied with a single knot and a double knot to form a first knotted portion 715 ( Figure 101E Each second suture 711 can be tied with the corresponding third suture 717 into a 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 ).

[0361] In this manner, marker 750 can be secured to tab 744 of connecting member 746 using the same sutures (or similar securing members) used to secure the commissure tabs of adjacent leaflets to the inner surface of connecting member 746. This can simplify the assembly process of the prosthetic heart valve, thereby saving time and assembly costs.

[0362] As described above, the prosthetic valve can be mounted on a valve mounting portion (e.g., Figure 9-11 32A-32B ) around and radially compress (e.g., crimp) the valve mounting portion 324 of the delivery device 300 to deliver the valve to the target implantation site (e.g., a native valve of the heart). In some embodiments, the expandable balloon of the delivery device (e.g., Figure 9-11 and 32A-32B ). Thus, the diameter of the prosthetic valve crimped onto the folded balloon in a radially compressed configuration may also be minimized.

[0363] Figure 36 An embodiment of an expandable balloon 818 is shown folded around the distal portion 809 of the delivery device 800. The delivery device 800 may be similar to Figure 9-11 The delivery device 300 of claim 1 includes one or more shoulders 802 mounted on an inner shaft 808 that extends distally from an intermediate (e.g., balloon) shaft 806. A balloon 818 covers a valve mounting portion 824 of a distal end portion 809 of the delivery device 800. The portion of the balloon 818 at the valve mounting portion 824 may include one or more axially extending folds or corrugations 830. Such axial corrugations 830 may be tightly compressed to minimize the profile of the balloon 818 and the prosthetic heart valve crimped thereon.

[0364] In some embodiments, when the balloon 818 is in a deflated state ready for insertion into the patient's vasculature, the distal portion 832 of the balloon 818 can include one or more axial folds or corrugations 834. In some embodiments, when the balloon is in a deflated state ready for insertion into the patient's vasculature, the proximal portion 836 of the balloon 818 can include one or more axial folds or corrugations 838. The axial corrugations 834, 838 can reduce the overall profile of the distal portion 809 of the delivery device 800 to facilitate passage of the delivery device 800 through the introducer sheath and the patient's vasculature. Further details of folding or wrapping the balloon around the distal portion of the delivery device are described in U.S. Provisional Application No. 63 / 051,244, filed on July 13, 2020, which is incorporated herein by reference.

[0365] In some embodiments, as Figure 9-11 The balloon 318 of the delivery device 300 shown in Figures 28 and 32A-32B can be folded similarly to the balloon 818 described above. Figure 37 FIG is an exemplary cross-sectional view of the balloon 318 of the delivery device 300, which is wrapped and folded around the inner shaft 308 at the valve mounting portion 324 of the delivery device 300. Figure 37 As shown, when in its deflated configuration and when a prosthetic valve is mounted on and radially compressed about balloon 318, balloon 318 includes a plurality of overlapping corrugations or folds 390. Balloon 318 can be folded in such a manner that the corrugations 390 result in a minimized folded balloon diameter (e.g., in its deflated configuration), which can reduce the diameter of the radially compressed prosthetic valve when the prosthetic valve is crimped thereon.

[0366] As referenced above Figure 9-11 As described, the distal portion 309 of the delivery device 300 may include a distal tip portion 328 mounted on the distal end of the outer shaft 304. To deliver the prosthetic valve to the target implantation site, the outer shaft 304 and the intermediate shaft (e.g., balloon shaft) 306 may be axially moved relative to each other such that the distal tip portion 328 is disposed within the proximal portion (e.g., proximal portion 333, as shown) of the balloon 318. Figure 10318 ). Thus, the distal tip portion 328 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 portion of the delivery device to the target implantation site. For example, in some embodiments, the intermediate shaft 306 can be pulled into the outer shaft 304, or the outer shaft 304 can be pushed over the intermediate shaft 306, thereby moving the proximal portion of the balloon 318 into the interior of the distal tip portion 328. In some embodiments, the distal tip portion 328 can include internal and / or external expansion cutouts or grooves that provide flexibility to the distal tip portion 328 and allow it to expand radially outward as it moves over the proximal portion of the balloon 318, thereby increasing its ability to act as a balloon shoulder and prevent axial movement of the radially compressed prosthetic valve mounted around the balloon 318 at the valve mounting portion 324.

[0367] In some embodiments, the expanded cutouts of the distal tip portion disposed 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 device). However, these axially extending expanded cutouts can cause problems when rotationally aligning the distal tip portion of the delivery device at a target implantation site as described herein when the balloon shaft (e.g., intermediate shaft 306) to which the balloon 318 is mounted is rotated (because the balloon 318 rotates due to the rotation of the balloon shaft). For example, during rotation of the balloon or intermediate shaft, the folds of the balloon 318 (as described above with reference to FIG. 1 ) may be folded. Figure 36 and 37 The axially extending expansion cutout of the distal tip portion may be caught in the axially extending internal expansion cutout. An example of such an axially extending expansion cutout may be found in US Pat. No. 9,061,119, which is incorporated herein by reference.

[0368] Therefore, it may be desirable to have a distal tip portion that is configured to expand radially over the proximal portion of balloon 318 while also allowing balloon 318 to slide more easily within the distal tip portion without the folds of the balloon becoming stuck when rotating the middle shaft of the delivery device.

[0369] Figures 38-41 An embodiment of a distal portion 309 of a delivery device is shown wherein the outer shaft 304 includes a distal tip portion 900 mounted on the distal end of the outer shaft 304 and, in certain configurations, the balloon 318 includes a radial recess 334 ( Figure 40 and 41 ). In some embodiments, the distal tip portion 900 may be Figure 9 and 11 The distal top portion 328 of the .

[0370] The distal tip portion 900 can be configured as a flexure adapter including a flexure portion 912 and a coupling portion (also referred to as a straight portion) 914. The flexure portion 912 can extend from the 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 the distal end of the outer shaft 304 and mounted around the distal end of the outer shaft 304 ( Figure 39 ).

[0371] The flexure 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 flexure 912 .

[0372] The flexure 912 may 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). Figure 38 and 39 As shown, the inner expansion slot 902 is helical and curves about a central longitudinal axis 906 from a proximal end 908 of a flexure 912 (e.g., where the flexure 912 extends from a coupling portion 914) to a distal end 910 of the distal tip portion 900. The outer expansion slot 904 may also be helical and curve about the central longitudinal axis 906 from a proximal end 908 of the flexure 912 to a distal end 910 of the distal tip portion 900.

[0373] In some embodiments, each groove of the inner expansion grooves 902 can be curved from about 75 to about 110 degrees, from about 80 to about 100 degrees, or from about 85 to about 95 degrees about the central longitudinal axis 906. In some embodiments, each groove of the outer expansion grooves 904 can be curved from about 75 to about 110 degrees, from about 80 to about 100 degrees, or from about 85 to about 95 degrees about the central longitudinal axis 906.

[0374] In some embodiments, the inner expansion grooves 902 are spaced apart from one another and the outer expansion grooves 904 are spaced apart from one another around the circumference of the distal tip portion 900 .

[0375] In some embodiments, the inner expansion grooves 902 are offset (e.g., circumferentially offset) from the outer expansion grooves 904 such that the location where one outer expansion groove 904 is recessed into the outer surface of the distal tip portion 900 is disposed between the locations where two adjacent grooves of the inner expansion grooves 902 are recessed into the inner surface of the distal tip portion 900 (e.g., Figure 38 ).

[0376] The inner expansion groove 902 and the outer expansion groove 904 are configured to expand when the distal tip portion 900 is in the balloon 318 ( Figure 40 ) allows the flexure portion 912 to flex radially outward as the proximal portion 333 of the valve moves toward the valve mounting portion 324. Figure 41 The distal tip portion 900 is shown positioned above the proximal portion 333 of the balloon 318 during advancement of a radially compressed prosthetic valve 922 (which may be similar to one of the prosthetic valves described herein) mounted on a valve mounting portion 324 of a delivery device through the patient's vasculature and to a target implantation site.

[0377] The helical shape and orientation of the inner expansion grooves 902 can be configured such that during rotation of the intermediate (balloon) shaft 306 (e.g., to achieve commissure alignment at a target implantation site, as described herein), the folds of the balloon 318 (e.g., Figure 37 The engagement between the corrugations or folds 390 (shown) and the internal expansion grooves 902 is reduced, thereby allowing the balloon 318 to slide more easily along the inner surface of the distal tip portion 900 as the balloon 318 is rotated within the distal tip portion 900. For example, the helical shape and orientation of the internal expansion grooves 902 can prevent the corrugations of the balloon 318 from diving into and becoming lodged within the internal expansion grooves 902 as the intermediate shaft 306, and thus the balloon 318, is rotated.

[0378] After crimping the prosthetic valve onto the valve mounting portion 324 and advancing the distal tip portion 900 over the proximal portion 333 of the balloon 318 (e.g., Figure 41 ), the fluid disposed within the proximal portion 333 of the balloon 318 is displaced and pushed distally within the balloon 318. As a result, the distal portion 332 of the balloon 318 may overexpand radially outward and may cause an increase in the crimp profile (e.g., diameter) of the prosthetic valve 922. The increased crimp profile may result in increased resistance when the delivery device is advanced into and through the loader and sheath of the delivery assembly.

[0379] Therefore, to reduce or prevent an increase in the curled profile of the prosthetic valve 922, the distal portion 332 of the balloon 318 can be formed with a radial recess 334 ( ) that is recessed inwardly toward the central longitudinal axis 320 of the delivery device. Figure 40 and 41 In some embodiments, the radial recess 334 may be recessed inwardly relative to the outermost radial surface of the distal shoulder 326. Figure 40As shown, the distal portion 332 of the balloon 318 can extend over a wider flared portion 331 of the distal shoulder 326 (e.g., which can be formed by the wings 330), then recess radially inward toward the base portion 325 of the distal shoulder 326, and then extend radially outward back to the proximal end of the nose cone 322, thereby forming a radial recess. Figure 40 The balloon 318 including the radial recess 334 in the distal portion 332 is shown before the prosthetic valve is crimped onto the valve mounting portion 324 and the distal tip portion 900 is advanced over the proximal portion 333 of the balloon 318 .

[0380] After crimping the prosthetic valve onto the valve mounting portion 324 and advancing the distal tip portion 900 over the proximal portion 333 of the balloon 318 (e.g., Figure 41 ), the fluid disposed within the proximal portion 333 of the balloon 318 is displaced distally within the balloon 318 and pushed to the distal portion 332 of the balloon 318. The radially concave distal portion 332 of the balloon 318 can then radially expand (e.g., partially inflate) as it receives the displaced fluid. Figure 41 (solid line) and Figure 26 (dashed lines) in the expanded state 924. The radial recess 334 can be configured (e.g., sized) such that the distal portion 332 can receive displaced fluid without radially expanding the portion of the balloon 318 within the valve mounting portion 324, thereby preventing an increase in the crimp profile of the prosthetic valve 922.

[0381] Prior to inflating balloon 318 to deploy prosthetic valve 922 at the target implantation site, distal tip portion 900 can be moved axially away from prosthetic valve 922 and out of balloon 318 (by pulling outer shaft 304 proximally relative to middle shaft 306 or by pushing middle shaft 306 distally relative to outer shaft 304). Prosthetic valve 922 can then be deployed and radially expanded by inflating balloon 918.

[0382] When balloon 318 is inflated (e.g., when the distal portion of the delivery device and the prosthetic valve have reached the target implantation site (such as a native valve)), balloon 318 unrolls (e.g., opens) to its expanded state, thereby radially expanding the prosthetic valve to its radially expanded state. When 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 pleats 390 of the balloon causes the prosthetic valve to rotate during balloon inflation. As a result, the position of the radially expanded prosthetic valve is rotated a predetermined amount (e.g., 10°, 20°, 30°, etc.) from its position on the delivery device prior to inflating the balloon 318. In some embodiments, during manufacture of the delivery device, the balloon can be wrapped and / or folded in a consistent and / or standardized manner so that a consistent amount of rotation of the prosthetic valve occurs during valve deployment (e.g., for multiple delivery devices manufactured in the same manner).

[0383] Thus, it may be desirable to mount (e.g., crimp) the prosthetic valve in its radially compressed state onto the valve mounting portion of the delivery device so that selected commissures of the prosthetic valve are aligned with markers (e.g., Figure 28 Mark 500, Figure 30-32B Mark 600 or Figure 33-34B In some embodiments, the circumferential offset between the marker and the selected commissure of the prosthetic valve can be offset by a predetermined amount, or at least based on a predetermined rotation amount. In this manner, the circumferential offset between the marker and the selected commissure of the prosthetic valve can compensate for valve rotation that occurs during balloon inflation and valve deployment. In some embodiments, the predetermined offset can be based at least in part on the balloon winding and the resulting rotation of the valve that occurs during balloon inflation.

[0384] For example, deploying the prosthetic valve by inflating the balloon after aligning a marker on the delivery device with the guidewire within a selected imaging view (e.g., aligning an asymmetric marker with the guidewire such that the marker is disposed behind the selected imaging view) can cause the prosthetic valve to rotate and be implanted within the native valve with the commissures of the prosthetic valve aligned with the commissures of the native valve (as described in further detail below). In some embodiments, the markers on the delivery device can be configured to indicate the circumferential position of selected commissures of the prosthetic valve after valve deployment.

[0385] Figure 42 An example of a prosthetic valve 922 mounted in a radially compressed state on and about the valve mounting portion 324 of the distal portion 309 of the delivery device 300 is shown, wherein selected commissures (defined by Figure 42 600) 930 is circumferentially offset by a predetermined amount 932 from marker 600. As described above, upon deployment of the prosthetic valve 922 via inflation of the balloon, the prosthetic valve 922 can rotate by a predetermined amount 932 as it radially expands, such that the selected commissures 930 are ultimately circumferentially aligned with marker 600. Thus, the selected commissures 930 of the implanted prosthetic valve can be aligned with the selected commissures of the native valve.

[0386] In alternative embodiments, the predetermined offset 932 can be different from the predetermined amount of expansion of the prosthetic valve when deployed via inflation of the balloon. For example, as further described below, the predetermined offset can be determined based on a desired imaging view selected for viewing the delivery device in the heart during the implantation procedure (e.g., based on the known location of the target commissures of the native valve within the selected imaging view). In some embodiments, the predetermined offset can be determined based on the selected imaging view and a predetermined amount of rotation of the prosthetic valve when deployed.

[0387] In order to mount and crimp a prosthetic valve onto a valve mounting portion of a delivery device in a predetermined position and / or orientation (e.g., a circumferential position and / or orientation) relative to the delivery device (e.g., relative to a radiopaque marker on a distal shoulder or another portion of the distal portion of the delivery device), a mounting assembly can be used. The mounting assembly can include a first component and a second component, the first component being configured to dock with an uncrimped (e.g., at least partially radially expanded) prosthetic valve and the second component being configured to dock with a portion of the distal portion of the delivery device (e.g., a portion disposed proximal and / or adjacent to the valve mounting portion). The first component and the second component of the mounting assembly can be further configured to dock with different sides of the crimping device. Thus, the mounting assembly can maintain the prosthetic valve in a predetermined orientation and / or predetermined position relative to the delivery device within the crimper. Then, after the prosthetic valve is crimped onto the valve mounting portion of the delivery device, the prosthetic valve can be arranged in a radially compressed configuration in the 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 selected commissures of the prosthetic valve are circumferentially offset by a predetermined amount (e.g., as shown) from a marking (or other desired landmark) on the delivery device. Figure 42 shown).

[0388] Figures 43-52 1 shows an embodiment of various components that can be used in a mounting assembly that is configured to crimp a prosthetic valve (such as one of the prosthetic valves described herein) onto a valve mounting portion of a delivery device (e.g., valve mounting portion 324 of delivery device 300) in a predetermined position and orientation. The prosthetic valve can be crimped onto the valve mounting portion of the delivery device in various ways. In some embodiments, a crimping device (such as Figure 43 and 44 The crimping device 1084 shown can be used to crimp a prosthetic valve onto the valve mounting portion of the delivery device. As described further below, the crimping device 1084 can include mating interfaces on opposing sides of the crimping device 1084 that are configured to receive and mate with corresponding mating interfaces on the first and second components of the mounting assembly.

[0389] Figure 43A rear perspective view of the crimping device 1084 (or a view from the proximal side of the crimping device 1084) is shown, and Figure 44 A front perspective view (or a view from the distal side of the crimping device 1084) is shown of the crimping device 1084. The crimping device 1084 can include a base 1086, an actuator in the form of a handle 1088, and a channel 1090 for insertion of a prosthetic valve and a delivery device. The crimping device 1084 can include a proximal side 1092 including a proximal opening 1094 leading to the channel 1090. The proximal opening 1094 can be configured for insertion of a delivery device into the channel 1090 therethrough.

[0390] In some embodiments, the proximal side 1092 may include a mating interface having a mating structure 1096 in the form of a cutout, which may be configured to mate with, for example, Figure 49 The positioning device 1072 is shown mating. For example, the mating interface can include one or more mating structures 1096.

[0391] The crimping device 1084 can further include a rotatable body 1098 configured to rotate with rotation of the handle 1088. The crimping device 1084 can be operated by a plurality of pressing surfaces 1000 that surround the channel 1090 and are configured to apply a compressive force to radially compress the prosthetic valve positioned within the channel 1090 (e.g., Figure 51 and 52 1090 ). The prosthetic valve 922 is shown in FIG. 1090 , as further described below. The pressing surface 1000 can be circumferentially about the axis 1002 of the passage 1090. The pressing surface 1000 can be configured such that when the rotatable body 1098 rotates, the body compresses the pressing surface 1000 and moves the pressing surface 1000 toward the center of the passage 1090, and the diameter of the passage 1090 decreases. The pressing surface 1000 can form an iris structure that allows the pressing surface 1000 to move toward the center of the passage 1090 and decrease the diameter of the passage 1090. Due to the radial compressive force of the pressing surface 1000 against the prosthetic valve, the prosthetic valve positioned within the passage 1090 will be compressed within the passage 1090.

[0392] like Figure 44 As shown, the crimping device 1084 can include a distal side 1004 including a distal opening 1006 leading to a channel 1090. The distal side 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 notch, recess, depression, etc. in the distal side 1004. The cutout portion 1008 can be configured (e.g., shaped) to receive an alignment device (e.g., a prosthetic valve support body) for the prosthetic valve. Figure 45Alignment member 1024 is shown, as further described below).

[0393] Distal opening 1006 may be configured for passing a portion of a delivery device therethrough during a crimping operation performed by crimping apparatus 1084 .

[0394] In alternative embodiments, the configuration of the crimping device may vary.

[0395] In order to crimp the prosthetic valve onto the valve mounting portion of the delivery device, it may be desirable to hold the leaflets (e.g., Figure 2A and 2B The prosthetic heart valve 50 is shown with the leaflets 60 in an open position, thereby reducing the likelihood of degradation of the leaflets and / or their attachment to the frame of the prosthetic valve. Thus, in some embodiments, a support body configured to support and / or maintain one or more leaflets of a prosthetic valve in an open position can be used as a first component of a mounting assembly configured to retain the prosthetic valve and position the prosthetic valve within a crimper.

[0396] exist Figure 45 An exemplary support body 1010 is shown in FIG. The support body 1010 may be configured to be inserted into a curling device such as Figure 43 and 44 The support body 1010 can include a first end 1014 and a second end 1016. The support portion 1012 can include an outwardly facing support surface 1015 configured to receive a prosthetic valve thereon (e.g., to interface with the valve leaflets).

[0397] In some embodiments, as Figure 45As shown, the coupling portion 1013 can have a cylindrical shape with a cylindrical outer surface 1018. The coupling portion 1013 can extend from the first end 1014 to a first (e.g., proximal-facing) surface 1020, which can 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 can engage the coupling portion 1013 to the support portion 1012 including the support surface 1015. In some embodiments, the first surface 1020 can include an alignment element (such as a recess 1022) that can 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, as shown. Figure 47 and 48 shown.

[0398] An alignment member 1024 can be disposed on the coupling portion 1013 and configured to rotationally align the support body 1010 with the crimping device 1084. The alignment member 1024 can be circumferentially positioned on the coupling portion 1013 proximate the first end 1014 at a position that circumferentially aligns the support body 1010 within the crimping device 1084 in a predetermined position and orientation.

[0399] In some embodiments, as Figure 45 As shown, the alignment member 1024 may include an axially extending protrusion that extends axially outward from the first end 1014 of the support body 1010 toward the 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 crimping device 1084 (e.g., Figure 44 The cutout portion 1008 shown may be provided with a mating recess or other alignment feature.

[0400] For example, the alignment member 1024 can be configured to be inserted into the cutout portion 1008 on the distal face 1004 of the crimping device 1084 to rotationally align the support body 1010 with the crimping device 1084. The alignment member 1024 can be further configured to allow the support body 1010 to slide distally out of the cutout portion 1008 during operation of the crimping device 1084.

[0401] The support portion 1012 may 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 may have a tapered shape that tapers radially inward in a direction from the first surface 1020 to the second end 1016. For example, the diameter of the support portion 1012 may decrease from the first surface 1020 to the second end 1016. In some embodiments, the support portion 1012 may have a conical shape, such as Figure 45 In alternative embodiments, the support portion 1012 may have another shape that tapers as described above, such as a hexagonal or pyramidal shape.

[0402] In some embodiments, the support portion 1012 may have a maximum diameter that is smaller than the diameter of the cylindrical coupling portion 1013 .

[0403] In some embodiments, the connector portion 1026 ( Figure 45 ) can join the support surface 1015 to the first surface 1020 and can have an annular shape with a relatively constant diameter.

[0404] The support surface 1015 can be configured to provide a smooth, even, and stable position when the prosthetic valve is positioned about the support portion 1012 (e.g., Figure 50 1084 ), the inner surfaces of the leaflets of the prosthetic valve contact and rest on support surface 1015. Support surface 1015 can be configured to prevent the leaflets from moving to a closed position when the prosthetic valve is positioned around support portion 1012 and within crimping device 1084.

[0405] The tapered shape of the support portion 1012, as described above, can allow the support body 1010 to slide distally away from the crimping device 1084 when the pressing surface 1000 of the crimping device 1084 is pressed against the support surface 1015. Thus, the tapered shape of the support portion 1012 can cause the compressive force applied by the pressing surface 1000 to move proximally along the tapered shape of the support surface 1015, thereby moving the support body 1010 distally and out of the crimping device 1084. When the pressing surface 1000 is pressed against the tapered support surface 1015, the support surface 1015 can maintain the leaflets in an open position.

[0406] In this manner, the support body 1010 can be configured to slide axially away from the prosthetic valve during and as a result of crimping of the prosthetic valve by the crimping device 1084. For example, the support body 1010 can be configured to be inserted into the channel 1090 of the crimping device 1084 and to slide axially away from the channel 1090 as the crimping device 1084 crimps the prosthetic valve 922, and thus can slide in an axial distal direction (e.g., Figure 52 shown).

[0407] like Figure 45As shown, 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 device to extend therethrough. The inner surface of the support portion 1012 can define the central channel 1030. The central aperture 1028 can be located at the second end 1016, and the central channel 1030 can extend from the second end 1016 to the first end 1014.

[0408] 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 being placed against the support surface 1015 ( Figure 50 and 51 ).

[0409] In order to align the prosthetic valve 922 in a desired circumferential orientation around the support portion 1012 and to space the prosthetic valve 922 from the first surface 1020 at a desired spacing, a ring body (which may also be referred to as an alignment ring) can be used and positioned on the support body 1010.

[0410] For example, Figure 46 and 47 10. The ring body 1038 is shown in perspective views from different sides of a ring body 1038 that can be used with the support body 1010. The ring body 1038 can be configured to couple to and extend around the support body 1010. The ring body 1038 can include a first surface (which can be a proximal facing surface) 1040 ( Figure 46 ), a second surface 1042 (which may be a distal facing surface) opposite the first surface 1040 ( Figure 47 ), 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 may 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.

[0411] In some embodiments, the alignment guide may be positioned on the ring body 1038 ( Figure 46 The alignment guide may include one or more indicators 1050a-c (which may also be referred to as alignment marks) configured to indicate a desired circumferential (e.g., rotational) position of selected elements (e.g., commissures) of the prosthetic valve 922 relative to the ring body 1038 ( Figure 46 、 48and 50). Each indicator 1050a-1050c can further indicate a desired circumferential position of a 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 further described).

[0412] Each indicator 1050a-c may include a mark, 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 may include a change in the surface contour of the ring body 1038, such as a raised portion or a recessed portion (e.g., a groove). For example, Figures 46-48 Indicators 1050a-c shown in FIG50 each include a recessed portion in the form of a groove on first surface 1040 that extends to outer surface 1044. In some embodiments, indicators 1050a-c may be additionally printed thereon to change the color of the respective indicators 1050a-c, making the indicators easier to visualize. In some embodiments, indicators 1050a-c may be printed solely on ring body 1038 without using a change in surface contour (e.g., without a groove).

[0413] Indicators 1050a-c can be circumferentially spaced apart from one another on ring body 1038. In some embodiments, indicators 1050a-c can be equally spaced apart from one another around the circumference of ring body 1038. When ring body 1038 is coupled to support body 1010 and a prosthetic valve is arranged around support portion 1012 of support body 1010 (e.g., as in FIG. 1 ), the prosthetic valve 1050a-c can be spaced apart from one another circumferentially on ring body 1038. Figure 50 As shown in FIG. 1 , the circumferential position of each indicator 1050a-c can correspond to and indicate a desired position of one of the commissures of the prosthetic valve. Thus, the user can position the ring body 1038 on the support body 1010 and align the commissures 944a-c of the prosthetic valve 922 with the corresponding indicator 1050a-c ( Figure 50 ).

[0414] In some embodiments, the ring body 1038 can include one or more arms (also referred to as body portions) 1052, 1054, each arm extending around and defining a central channel 1048 (FIGS. 46 and 47). Each arm 1052, 1054 can have an arcuate shape that forms the ring body 1038. Each arm 1052, 1054 can comprise half or another amount of the ring body 1038, as desired.

[0415] The first arm 1052 may include a first end portion 1056 ( Figure 46 ) and a second end portion 1058 ( FIG. 47 ), wherein the first end portion 1056 is positioned at a pivot 1060 ( FIG. 47 ) connecting 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 a first end portion 1062 ( Figure 46 ) and a second end portion 1064 ( Figure 47 ). The coupler (which may also be referred to as a 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 second end portions 1058, 1064 of the respective first and second arms 1052, 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 remain around and be coupled to the support body 1010.

[0416] like Figure 46 and 47 As shown, a first lever (e.g., a radial extension) 1066 can extend radially outward from the first arm 1052, and a second lever (e.g., a radial extension) 1068 can extend radially outward from the second arm 1054. The first lever 1066 and the second lever 1068 can each be configured to be squeezed to rotate the first arm 1052 or the second arm 1054 about the pivot 1060, thereby causing the ring body 1038 to move to the open position.

[0417] The ring body 1038 can have an axial width 1071 ( ) that can define the spacing of the prosthetic valve from the first surface 1020 of the support body 1010. Figure 46 ).

[0418] 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 the recess 1022 of the support body 1010 ( Figure 45In alternative embodiments, coupler 1070 may be a differently shaped mating feature configured to mate with a corresponding feature on support body 1010 .

[0419] The coupler 1070 can be circumferentially positioned relative to the recess 1022 such that the ring body 1038 mates with the support body 1010 in a desired circumferential alignment. In this manner, the coupler 1070 and recess 1022 can rotationally align the ring body 1038 with the support body 1010 such that the prosthetic valve is circumferentially aligned in a desired orientation relative to the support body 1010 and the crimping device.

[0420] In operation, the ring body 1038 can be positioned on and / or about the support body 1010 with the indicators 1050a-c positioned in a desired rotational (e.g., circumferential) alignment relative to the support body 1010 (FIG. 48). For example, Figure 47 The illustrated coupler 1070 can be received within the recess 1022 to circumferentially align the ring body 1038 in a desired position relative to the support body 1010. In other embodiments, other alignment means can be utilized to rotationally align the ring body 1038 relative to the support body 1010 in a desired rotational alignment.

[0421] Ring body 1038 can abut first surface 1020 of support body 1010. Ring body 1038 can be configured to abut prosthetic valve 922 when prosthetic valve 922 is positioned on support body 1010. Thus, prosthetic valve 922 can be positioned on support surface 1015 with an end of prosthetic valve 922 abutting first surface 1040 of ring body 1038 and defining a position of prosthetic valve 922 on support surface 1015. Thus, ring body 1038 can include a spacer configured to define a position of prosthetic valve 922 on support body 1010.

[0422] In some embodiments, the ring body 1038 can be oriented in an open configuration with the arms 1052, 1054 open, and can then 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 Figure 45 On the connector portion 1026 shown.

[0423] 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 ).

[0424] 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, therefore, relative to the support body 1010 (e.g., relative to the alignment members 1024 of the support body 1010). The alignment members 1024 can then rotationally align the support body 1010 with the crimping device 1084 and, thereby, place the commissures 944a-c of the prosthetic valve 922 within the crimping device 1084 in the desired rotational orientation.

[0425] Thus, the prosthetic valve 922 can be crimped onto the delivery device in a predetermined circumferential orientation relative to the delivery device (eg, relative to radiopaque markers on the delivery device as described herein).

[0426] 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 to 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 portion) proximal to the valve mounting portion. For example, Figure 49 An embodiment of such a positioning device 1072 is illustrated positioned proximal to the valve mounting portion 324. 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 channel 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 rotating about the hinge 1080 to close the central channel 1082 and retain the delivery device (e.g., the intermediate shaft 306) within the central channel 1082.

[0427] The body 1074 may further include a flange portion 1053 including a flange 1051 ( Figure 49 ) in the form of one or more mating surfaces (e.g., interfaces), the flange 1051 is configured to engage the crimping device 1084 ( Figure 43 )'s proximal side 1092 has a mating structure 1096.

[0428] The positioning device 1072 can be used to couple to the distal portion 309 of the delivery device and suspend the distal portion 309 of the delivery device in an appropriate position within the channel 1090 of the crimping device 1084 ( Figure 51and 52). Thus, the positioning device 1072 can keep the delivery device spaced apart from the pressing surface 1000 of the crimping device 1084, e.g. Figure 51 shown.

[0429] Additionally, the positioning device 1072 can be positioned axially along the delivery device such that the valve mounting portion 324 remains in a defined axial position within the channel 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 and distal to the channel 1090 of the crimping device 1084 such that the distal shoulder 326 is not compressed by the compression surface 1000 during crimping. The delivery device can further be maintained in a defined axial position relative to the prosthetic valve 922 positioned on the support body 1010 ( Figure 51 ).

[0430] An exemplary method of operation of the system disclosed herein may include the following steps. Steps may be modified, eliminated, or replaced as needed across embodiments.

[0431] Initially, the ring body 1038 may be formed as, for example Figure 48 The structure shown is positioned on the support body 1010. The ring body 1038 can be positioned, for example, via Figure 47 The coupler 1070 is shown with Figure 48 The prosthetic valve 922 is rotationally oriented in a defined position on the support body 1010 by coupling the recess 1022 as shown. Thus, the prosthetic valve 922 can be positioned on the support surface 1015 with the commissures 944a-c of the prosthetic valve 922 circumferentially aligned with the indicators 1050a-c (e.g., Figure 50 The prosthetic valve 922 can be positioned against the ring body 1038 .

[0432] 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 before crimping the prosthetic valve 922 onto the delivery device. 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.

[0433] 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, Figure 51The prosthetic valve 922 is shown positioned on and about the support portion 1012, and the support body 1010 is inserted into the channel of the crimping device 1084. The distal opening 1006 of the crimping device 1084 can be configured for insertion of the support body 1010 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 portion 309 of the delivery apparatus.

[0434] When the support body 1010 is inserted into the channel 1090 of the crimping device 1084, the alignment member 1024 can be aligned with (e.g., 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 a desired position.

[0435] With the support body 1010 and prosthetic valve 922 inserted into the channel 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 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 matching structure 1096.

[0436] Figure 51 A cross-sectional view of the compression surface 1000 and the support body 1010 inserted into the channel 1090 of the crimping device 1084 is shown with the prosthetic valve 922 positioned around the support portion 1012 .

[0437] like Figure 51 As shown, the support portion 1012 of the support body 1010 extends axially within the channel 1090 toward the proximal opening 1094 of the crimping device 1084. The support surface 1015 can be surrounded by the pressing surface 1000. The coupling portion 1013 of the support body 1010 can be disposed externally and distally of the pressing surface 1000 and can be retained 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.

[0438] exist Figure 511084. The valve mounting portion 324 of the delivery device is positioned within the channel 1090 of the crimping device 1084. The prosthetic valve 922 is positioned within the channel 1090 and around the valve mounting portion 324 of the delivery device. The support body 1010 is positioned within the channel 1090 and between the prosthetic valve 922 and the delivery device. The support body 1010 supports the leaflets of the prosthetic valve 922 in an open position. The distal portion 309 of the delivery device extends distally within the interior channel 1090 of the crimping device 1084 and extends distally within the central channel 1030 of the support body 1010.

[0439] When inserted into the crimping device 1084, the positioning device 1072 can be coupled to the distal portion 309 of the delivery device proximal to the valve mounting portion 324 and can engage with the mating structure 1096 of the proximal side 1092. The positioning device 1072 can be coupled to the distal portion 309 of the delivery device in a position that positions the valve mounting portion 324 within the channel 1090 and in a desired position relative to the prosthetic valve 922. For example, as shown in FIG. Figure 51 As shown, the prosthetic valve 922 can surround the valve mounting portion 324.

[0440] As described above, due to the prior use of ring body 1038, the rotational alignment of prosthetic valve 922 relative to distal end portion 309 of the delivery apparatus can be in a desired predetermined orientation and / or position.

[0441] With the distal portion 309 of the delivery device, the support body 1010, and the prosthetic valve 922 in the desired position within the passage 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 pressing surface 1000 radially inward against the prosthetic valve 922 ( Figure 43 and 44 ).

[0442] For example, Figure 52 The illustration shows that the pressing 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 device using the pressing surface 1000 of the crimping device 1084. Figure 52 As shown, in its radially compressed state, the length of the prosthetic valve 922 has increased in the axial direction.

[0443] Crimping the prosthetic valve 922 onto the delivery device may include applying a force to the support surface 1015 of the support body 1010 using the compression surface 1000, thereby causing the support body 1010 to slide axially within the channel 1090 away from the prosthetic valve 922 ( Figure 52 ).

[0444] For example, as described above, 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 channel 1090 and away from the pressing surface 1000 as the pressing surface 1000 moves radially inward. 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 channel 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 shown in FIG. Figure 52 The elongated shape of the alignment member 1024 can allow the alignment member 1024 to slide out of the cutout portion 1008 .

[0445] In embodiments, the support body 1010 may not pop out, but may remain coupled to the crimping device 1084 during crimping. For example, the support body 1010 may slide distally while a tether or another form of coupling holds the support body 1010 coupled to the crimping device 1084 so that the support body 1010 does not fall.

[0446] After the prosthetic valve 922 is crimped onto the delivery device, the positioning device 1072 can be disengaged from the mating structure 1096 and moved outward from the proximal opening 1094, thereby moving the delivery device outward and away from the crimping device 1084. The positioning device 1072 can then be removed from the distal portion 309 of the delivery device to which the prosthetic valve 922 is crimped.

[0447] In this manner, the use of a mounting assembly including support body 1010 can allow the leaflets of prosthetic valve 922 to remain in an open position during crimping. Such a feature can reduce the likelihood of degradation of prosthetic valve 922 during crimping. Additionally, the tapered shape of support surface 1015 can allow support body 1010 to slide outward from the crimping device via radially inward movement of pressing surface 1000, automatically moving support body 1010 outward and away from the crimped prosthetic valve 922. Support body 1010 can automatically slide axially outward so that support surface 1015 is not positioned between prosthetic valve 922 and pressing surface 1000 after crimping. In some embodiments, the system can be configured so that a separate mechanism slides support body 1010 distally, eliminating the need for a tapered shape for support surface 1015. For example, an arm, gear, or another form of coupling can engage support body 1010 to move support body 1010 away from prosthetic valve 922.

[0448] In some embodiments, the mounting assembly may include differently configured positioning features configured to mate with one or more mating structures disposed on a side of the crimping device (eg, mating structure 1096 of crimping device 1084). Figure 53 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 54 and 55 A side view and a perspective view, respectively, are shown of the positioning device 1100 coupled to the distal portion 309 of the delivery apparatus 300 proximal to the valve mounting portion 324 .

[0449] like Figure 53 As shown, the positioning device 1100 may include a body 1102 including a first portion 1104 and a second portion 1106 pivotably coupled to each other via a hinge 1108. The body 1102 may include a central channel 1110 ( Figure 53 ), the central channel 1110 is configured to receive the intermediate shaft 306 (or another shaft portion, such as the outer shaft 304) of the delivery device 300 (Figures 54 and 55).

[0450] The second portion 1106 of the body 1102 may include a flange portion 1112 extending radially outward therefrom and disposed at the distal end of the positioning device 1100. The flange portion 1112 may include one or more mating elements configured to mate with correspondingly shaped mating features in a side surface (e.g., a proximal side) of the crimping device. In some embodiments, as Figure 53 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 the circumference of the flange portion 1112.

[0451] In some embodiments, flange portion 1112 can include one or more indicator elements 1116 that can indicate the direction in which extension portion 1114 can be inserted into the crimping device.

[0452] like Figure 54 and 55 As shown, the positioning device 1100 is clamped around the intermediate shaft 306 at a location proximal and near the proximal end portion of the balloon 318.

[0453] 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 herein by reference.

[0454] Figure 56is a flow chart of an exemplary method 1200 for crimping a prosthetic valve into a radially compressed state at a predetermined position and in a predetermined orientation relative to a delivery device to a distal portion of a delivery device. In some embodiments, the method 1200 may be performed using the method described herein. Figures 43-55 Describes one or more components of an installed assembly.

[0455] Method 1200 begins at 1202 by inserting a prosthetic valve (e.g., Figure 1 Prosthetic valve 10, Figures 2A-2B Prosthetic valve 50 or Figure 41 The prosthetic valve 922) is placed (e.g., positioned) onto the implant holder device such that one or more commissures of the prosthetic valve are aligned with one or more corresponding indicators or alignment marks on an alignment ring (or ring body) coupled to the implant holder device. The implant holder device can be configured to receive an at least partially radially expanded prosthetic valve and to hold the prosthetic valve in a desired circumferential orientation. In some embodiments, the implant holder device can be Figure 45 and 48 The support body 1010, and the alignment ring can be Figures 46-48 and the ring body 1038 of 50. For example, in some embodiments, the method at 1200 can include rotationally aligning the prosthetic valve on the support portion of the support body such that one or more commissures of the prosthetic valve mate and align with corresponding indicators on the ring body (e.g., as Figure 50 In an alternative embodiment, the alignment ring may be Figures 65-68 One of the alignment rings shown.

[0456] After aligning the commissures of the prosthetic valve on the implant holder device, method 1200 proceeds to 1204, which includes removing the alignment ring from the implant holder device while the circumferentially aligned prosthetic valve remains attached to the implant holder device.

[0457] At 1206, the method includes attaching a positioning device to the delivery device. In some embodiments, attaching the positioning device can include coupling a portion of the positioning device around a shaft of the delivery device proximal to the valve mounting portion of the delivery device and the proximal portion of the inflatable balloon of the delivery device. In some embodiments, the positioning device can be coupled to and around a middle (e.g., balloon) shaft of the delivery device (e.g., middle shaft 306, as shown). Figure 54 The positioning device may be one of the positioning devices described herein (e.g., Figure 49 Positioning device 1072 or Figures 53-55The method may further include coupling the positioning device to the delivery device such that, upon coupling the positioning device to the crimping device, radiopaque markers on the delivery device are maintained in the desired circumferential orientation within the crimping device.

[0458] Method 1200 proceeds to 1208 and includes placing (eg, arranging or coupling) a distal portion of a delivery device and a positioning device to a crimping device (eg, Figure 43 and 44 In one embodiment, the delivery device is positioned so as to be positioned relative to the prosthetic valve and to provide a first side (e.g., proximal side) of the crimping device 1084 or another crimping device. For example, a flange portion of a positioning device comprising one or more mating elements can be coupled to the first side of the crimping device such that the one or more mating elements mate with one or more corresponding mating elements in the first side of the crimping device. Thus, a distal portion of the delivery device coupled to the positioning device can be disposed within the crimping device, wherein the valve mounting portion is disposed within a portion of the crimping device configured to press against and crimp the prosthetic valve. In this manner, the positioning device and the valve mounting portion of the delivery device can be received within the crimping device in a predetermined circumferential orientation and position.

[0459] At 1210, the method includes placing an implant holder device into a second side (e.g., distal side) of the crimping device. For example, at 1210, the method may include inserting the implant holder device into the second side of the crimping device such that an alignment member of the implant holder device is inserted into and / or engages with a corresponding mating structure or element of the crimping device. In this manner, the implant holder device and a prosthetic valve disposed on the implant holder device can be received within the crimping device in a predetermined orientation. For example, when both an implant holder device coupled to the prosthetic valve and a positioning device coupled to the delivery device are coupled to the crimping device, a selected commissure of the prosthetic valve can be aligned in a circumferential direction relative to a central longitudinal axis of the delivery device from a radiopaque marker on a distal portion of the delivery device (e.g., such as Figure 28 、 32A -One of the marks shown in -32B or 42) is offset by a predetermined amount.

[0460] At 1212, the method includes crimping the prosthetic valve into a radially compressed state onto a valve mounting portion of a delivery device using a crimping device. In some embodiments, crimping the prosthetic valve at 1212 can include crimping the prosthetic valve into its radially compressed state around an inflatable balloon at the valve mounting portion. Additionally, in some embodiments, crimping the prosthetic valve at 1212 can include crimping the prosthetic valve into the radially compressed state onto the valve mounting portion of the delivery device while maintaining a predetermined offset (e.g., such as a predetermined offset) between the radiopaque marker and selected commissures of the prosthetic valve. Figure 42 As further described below, the predetermined offset can be determined (e.g., preselected) based on a desired or selected imaging view for imaging the distal portion of the delivery device and rotationally aligning the prosthetic valve with the native anatomy (e.g., to achieve commissure alignment) during the implantation procedure. During crimping at 1212, in some embodiments, the implant holder device can automatically detach from the prosthetic valve and / or crimping device (e.g., as described above with reference to Figure 51 and 52 description).

[0461] At 1214, the method includes removing the distal portion of the delivery device on which the prosthetic valve is crimped from the crimping device. At 1214, the method can further include removing (e.g., detaching) the positioning device from the delivery device. In this manner, the positioning device can be removably coupled to the delivery device, and the implant holder device can be removably coupled to the prosthetic valve, as described above. After being removed from the crimping device, the delivery device can then be ready for insertion into the patient's blood vessel and navigation to the patient's heart.

[0462] Figure 57 is a flow chart of an exemplary 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, method 1300 can be performed using a delivery device configured to deploy a radially compressed prosthetic valve mounted on a distal portion of the delivery device via inflation of a balloon of the delivery device. Figure 9-11, an exemplary delivery device 300 is shown in FIG. The delivery device can include one or more of the components described herein to help rotationally align the delivery device at the implantation site (e.g., a native valve) to achieve the commissure alignment described above. In an alternative embodiment, method 1300 can be performed using a delivery device that is configured to deploy a radially compressed prosthetic valve by axially moving a sheath or capsule covering the radially compressed prosthetic valve relative to an axis of the delivery device (and thus moving the capsule rather than inflating a balloon to deploy the prosthetic valve).

[0463] Method 1300 begins at 1302 and includes receiving a prosthetic heart valve mounted on a distal portion of the delivery device in a radially compressed configuration with an expandable balloon surrounding the delivery device in a predetermined position and in a predetermined orientation relative to the delivery device such that selected commissures of the prosthetic heart valve are offset by a predetermined amount from a radiopaque marker on the distal portion of the delivery device 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 58-68 Further described.

[0464] In some embodiments, as described above with reference to Figure 30-34B As described above, the marker can be reflectively asymmetrical along an axis parallel to the central longitudinal axis. In some embodiments, the marker can be positioned on a polymeric 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, which is disposed distal to the valve mounting portion of the delivery device (e.g., Figures 32A-32B and 42).

[0465] In some embodiments, at 1302, the method may include crimping a prosthetic heart valve onto a distal portion of a delivery device using a mounting assembly, as described above with reference to FIG. Figure 56 The method described.

[0466] At 1304, the method includes advancing the distal portion of the delivery device toward the native valve of the patient's heart. In some embodiments, at 1304, the method can further include first inserting the distal portion of the delivery device into the patient's vasculature with the expansion port of the adapter of the delivery device facing the user (e.g., the user performing the implantation procedure) so that the radiopaque marker entering the patient is oriented so that it faces the table on which the patient is positioned (e.g., due to the arrangement of the adapter 312 and the rotatable knob 314 relative to the marker, as described above with reference to FIG. Figure 15-22 description).

[0467] After advancing the distal portion of the delivery device to a position proximate to the native valve (e.g., within the patient's heart), the method continues to 1306 and includes visualizing, under fluoroscopy and for a selected imaging view, the position of a radiopaque marker on the distal portion of the delivery device relative to a guidewire extending through the shaft of the delivery device. For example, as described above with reference to Figure 29 、 31A As described in Figures 31B and 34A-34B, using medical imaging such as fluoroscopy, the radiopaque marker can be visualized along with the guidewire and another component (e.g., a valve frame of a prosthetic valve mounted on a delivery device). The position of the radiopaque marker relative to the guidewire can be seen in selected imaging views (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). Figure 29 ). Thus, because fluoroscopy does not provide a perspective to naturally distinguish what is in front of and behind a selected imaging view, such a perspective can be provided by visualizing the position of the asymmetric marker relative to the guidewire, as further described below.

[0468] As referenced below Figures 61-64 As further described, the user can select from a plurality of possible imaging views for imaging the heart and the position of the distal portion of the delivery device relative to the native valve. For each imaging view, the position of target commissures of the native valve to be aligned with selected commissures of the prosthetic heart valve (after implantation) can be known within the selected imaging view. Figure 58 An exemplary fluoroscopic image 1400 of a native (e.g., aortic) valve 1402 viewed using a more standard tricuspid valve imaging view is shown in FIG. Figure 58 As shown, the native aortic valve 1402 includes three leaflets: a noncoronary cusp 1404, a right coronary cusp 1406, and a left coronary cusp 1408. In the tricuspid view, the noncoronary cusp 1404 and the left coronary cusp 1408 are arranged opposite each other in the view and are both overlapped by a portion of the right coronary cusp 1406. Therefore, it is known that the commissures between the noncoronary cusp 1404 and the left coronary cusp 1408 are located at the back of the image 1400.

[0469] At 1308, the method includes, prior to passing through the native valve, rotating the shaft of the delivery device, 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. The method at 1308 can be performed while imaging the heart and observing the selected imaging view.

[0470] In some embodiments, the predetermined orientation in the selected imaging view is directly behind the imaging view (e.g., away from the observer). In alternative embodiments, the predetermined orientation in the selected imaging view can be directly in front of the imaging view (e.g., toward the observer). Thus, in some embodiments, the radiopaque marker can be configured as an asymmetric marker having a first orientation when it is in front of the guidewire (e.g., directly in front of the imaging view) and a different second orientation when it is behind the guidewire (e.g., directly behind the imaging view). In this way, the asymmetric marker can help the user distinguish between whether the marker is positioned in front of and behind the selected imaging view (compared to symmetrical markers that appear the same to the observer in the imaging view).

[0471] For example, in some embodiments, Figure 59 As shown, the asymmetric markers 600 can be configured as letters of the alphabet when the markers are centered along the guidewire 606 and positioned just behind the imaging view (e.g., behind the guidewire, as shown in FIG. Figure 59 ), the letters of the alphabet appear forward (e.g., a "C" that can be read forward, as Figure 31A ), and when the marker is centered along the guidewire and positioned directly in front of the imaging view, the letters of the alphabet appear backward (e.g., a backward "C," as shown). Figure 31B ). Thus, at 1308, the method may include rotating the shaft of the delivery device, which rotates the prosthetic heart valve and the marker until the marker is centered along the guidewire within the selected imaging view and appears in its anterior orientation, positioning the marker directly behind the imaging view.

[0472] In alternative embodiments, the asymmetric marker may appear anteriorly when the marker is centered along the guidewire and positioned directly in front of the imaging view (e.g., in front of the guidewire), and the asymmetric marker may appear posteriorly when the marker is centered along the guidewire and positioned directly behind the imaging view. Thus, in these embodiments, at 1308, the method may include rotating the axis of the delivery device, which rotates the prosthetic heart valve and the marker until the marker is centered along the guidewire within the selected imaging view and appears in its posterior orientation, thereby positioning the marker directly behind the imaging view.

[0473] In other embodiments, the method may include rotating the axis of the delivery device, which rotates the prosthetic heart valve and the marker until centered along the guidewire within the selected imaging view and appearing in a predetermined orientation (posterior or anterior) to position the marker directly in front of the imaging view at 1308. In this manner, a predetermined offset between a selected commissure of the prosthetic heart valve and the marker on the delivery device can be determined based on the selected imaging view and the target orientation of the marker in the selected imaging view (directly anterior or directly posterior).

[0474] By rotating the distal portion of the delivery device before passing through the native valve, blood flow through the native valve (which may be stenotic) may not be obstructed by the delivery device. Additionally, in some embodiments, if a curled prosthetic valve were to be rotated within (e.g., across) a native valve (which may have calcified leaflets), emboli could be created by knocking calcium from the leaflets, which could lead to a stroke or other medical complications. Thus, by rotating the distal portion of the delivery device and the radially compressed prosthetic valve outside the native valve (e.g., in the ascending aorta), emboli and other complications can be reduced or avoided. Additionally, the user may spend more time rotating because the delivery device is not in a position where it could obstruct blood flow through the native valve.

[0475] After achieving the desired rotational positioning of the radiopaque marker relative to the guidewire at 1308, the method continues to 1310, which includes advancing a distal portion of a delivery device including a 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 selected commissures of the prosthetic heart valve are aligned with target commissures of the native valve.

[0476] In some embodiments, during inflation, as the prosthetic heart valve radially expands, the prosthetic heart valve rotates an amount equal to a predetermined offset between the marker and the selected commissure when the prosthetic heart valve is radially compressed about the balloon. Figure 60 As shown in the exemplary schematic diagram of FIG, when it is known that the target commissures 1450 of the native valve 1452 are to be directly behind the selected imaging view for rotational positioning at the implant site and the marker 600 is aligned directly behind the selected imaging view, when the prosthetic heart valve is radially compressed about the balloon, the prosthetic valve 922 can be rotated by an amount equal to the predetermined offset between the marker and the selected commissures 930 of the prosthetic valve 922 (as determined by Figure 60 ), thereby implanting the prosthetic valve 922 with the selected commissure 930 circumferentially aligned with the target commissure 1450 of the native valve 1452.

[0477] In an alternative embodiment, during inflation, as the prosthetic heart valve radially expands, the prosthetic heart valve rotates more or less than the amount of offset between the marker and the selected commissure when the prosthetic heart valve is radially compressed about the balloon. However, the offset can be predetermined based on the selected imaging view and prior 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 so that when the balloon is expanded, the prosthetic valve is rotated and implanted with the commissures aligned with the commissures of the native valve.

[0478] Reference below Figures 61-68 Examples of such rotational alignment and adjustment of circumferential offsets between markers on a delivery device and selected commissures of a radially compressed prosthetic heart valve for different imaging views are described.

[0479] exist Figure 61 , a schematic diagram of a first embodiment of a more standard tricuspid valve imaging view 1500 of a native valve 1510 is shown, which, as described above, can be used to visualize a delivery device in a patient's heart and rotationally align a prosthetic valve during an implantation procedure. In the tricuspid valve imaging view 1500, the non-coronary cusps 1502 and the left coronary cusp 1504 of the native valve (e.g., aortic valve) 1510 are arranged relative to each other in the view and are each overlapped by a different portion of the right coronary cusp 1506, with all three cusps aligned along the transverse axis 1508. Thus, as Figure 62 As shown in the cross-sectional view of the native valve 1510 in FIG, for the tricuspid valve imaging view 1500, the selected commissure 1512 of the native valve 1510 arranged between the non-coronary cusp 1502 and the left coronary cusp 1504 is arranged directly behind 1514 of the tricuspid valve imaging view 1500. Figure 62 Also shown is a view just behind 1516 of the imaging view in which the right coronary artery cusp 1506 is located.

[0480] In comparison, Figure 63A schematic diagram of a second embodiment of a different right / left cusp overlap view 1550 of a native valve 1510 is shown, which, as described above, can be used to visualize a delivery device in a patient's heart and rotationally align a prosthetic valve during an implantation procedure. 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. Figure 64 As shown in the cross-sectional view of the native valve 1510 in FIG, for the right / left cusp overlap view 1550, the selected commissure 1512 is circumferentially offset from just behind 1514 of the imaging view.

[0481] It should be noted that in alternative embodiments, different commissures of the native valve (other than the commissure disposed between the non-coronary cusp and the left coronary cusp) can be the selected commissures on which the predetermined offset between the marker and the selected commissure of the prosthetic valve is at least partially based.

[0482] Therefore, for Figure 61 and 63 In the two different imaging views shown, the circumferential offset between the radiopaque marker on the delivery device and the selected commissures of the radially compressed prosthetic valve can be different predetermined offset values. In some embodiments, the implantation 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 as described above using different selected imaging views), including rotationally aligning the radiopaque marker on the delivery device with the guidewire so that the marker is positioned directly behind the imaging view (e.g., as shown in FIG. 2 ). Figure 59 and 60 ). However, the mounting of the prosthetic valve to the delivery device can be adjusted such that different circumferential offsets between the markers and selected commissures of the prosthetic valve are used for different procedures using different imaging views, wherein the circumferential offsets determined for the selected imaging views result in implantation of the prosthetic valve into the native valve with the commissures aligned with the commissures of the native valve.

[0483] It should be noted that Figure 61 and 63The two imaging views shown are examples of two different imaging views that can be used to rotationally align a prosthetic valve at the native valve during a valve implantation procedure. However, additional different imaging views that position the target commissures of the native valve in different positions directly behind (or in front of) the selected imaging view are possible and can also be used with the systems and methods described herein. In this way, the user can select from multiple possible imaging views and select (or target) commissures (e.g., Figure 62 and 64 The circumferential position of the illustrated commissures 1512 ) relative to the posterior (or anterior) side of the selected imaging view may be known (eg, predetermined).

[0484] In some embodiments, different alignment rings for mounting components (e.g., Figures 46-48 The ring body 1038 shown is similar to the ring body) or the alignment ring is arranged on the implant holder device (for example, such as Figure 45 and 48 Different indicators of the aligned position of one or more commissures of a prosthetic valve on the support body 1010 of the prosthetic valve can be used in different selected imaging views of the valve implantation procedure.

[0485] Figures 65-68 Exemplary embodiments of different alignment rings are shown that can be used in a mounting assembly and are configured to rotationally align a prosthetic valve on an implant holder device, thereby causing the prosthetic valve to curl onto the valve mounting portion of the delivery device in a predetermined circumferential orientation relative to a radiopaque marker on a distal portion of the delivery device. For example, the alignment ring can be configured to cause the prosthetic valve to be radially compressed onto the delivery device when a selected commissure is circumferentially offset from a radiopaque marker on the distal portion of the delivery device by a predetermined amount, the predetermined amount being determined (e.g., selected) based on a selected imaging view for use during the implant procedure. In some embodiments, as Figure 65 and 66 As shown, different alignment rings can be similar in overall shape and function, but have different arrangements of indicators or markers that are unique to the selected imaging view they are intended to be used in. For example, different alignment rings with unique arrangements of indicators or markers can be configured to align a prosthetic valve on an implant holder device in such a manner that selected commissures of the prosthetic valve are offset relative to radiopaque markers on a delivery device by an appropriate amount, which aligns the commissures of the prosthetic valve with the native valve when the prosthetic valve is deployed from the delivery device with the radiopaque markers aligned with the guidewire as described above.

[0486] Figure 65One embodiment of an alignment ring 1600 is shown that can be configured to use a first imaging view, such as a tricuspid valve imaging view (e.g., Figure 61 The prosthetic valve may be rotationally aligned with the delivery device for an implantation procedure to rotationally align and implant the prosthetic valve with the delivery device at the native valve. The alignment ring 1600 may be configured to enable mounting of the prosthetic valve onto the delivery device with selected commissures of the prosthetic valve circumferentially offset from radiopaque markers on the delivery device by a first predetermined amount, the first predetermined amount resulting in implantation of the prosthetic valve with the commissures aligned with commissures of the native valve after deployment of the prosthetic valve using the delivery device with the radiopaque markers aligned with the guidewire in their predetermined orientation (e.g., this indicates that the markers are positioned directly behind the imaging view).

[0487] The alignment ring 1600 can be configured (eg, constructed) to Figure 46 and 47 For example, the alignment ring 1600 may include one or more indicators (eg, alignment indicators or markings) 1610a-c disposed on one or more surfaces of the body 1602 of the alignment ring 1600. Figure 46 and 47 As depicted, indicators 1610a-c may be depressions (e.g., grooves) or etchings in one or more surfaces, raised features extending radially outward from one or more surfaces, and / or markings (e.g., printed, painted, or stamped lines) on one or more surfaces.

[0488] like Figure 65 As shown, the alignment ring 1600 includes three indicators 1610a-c spaced apart from one another around the circumference of the alignment ring 1600. 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 may be configured to be aligned when the alignment ring is coupled to an implant holder device (e.g., as Figure 48 As shown), when the prosthetic valve is mounted on an implant holder device (e.g., such as Figure 45 and 48 When the support body 1010 is shown around the prosthetic valve, the desired orientation of the commissures is indicated. Figure 65 As shown, the first indicator 1610a can be spaced apart from the first lever (eg, radial extension) 1604 by a first arc length 1606 .

[0489] In some embodiments, the alignment ring 1600 may include additional markings or indicators that indicate its intended use in aligning the prosthetic valve to be implanted during the implantation procedure using tricuspid valve imaging views. Figure 65 As shown, the alignment ring includes a first label 1608 ("View A") indicating the selected imaging view for the implant procedure. In some embodiments, the selected imaging view (View A) can be the tricuspid valve imaging view described above. In alternative embodiments, the first label 1608 can be a color code, a symbol, a numeric code, etc.

[0490] Figure 66 Another embodiment of an alignment ring 1700 is shown that can be configured to use a second imaging view, such as a right / left cusp overlap imaging view (e.g., Figure 63 The apparatus of claim 1700 further includes a prosthetic valve that is rotationally aligned with the delivery device for an implantation procedure to rotationally align the prosthetic valve with the delivery device and implant the prosthetic valve at the native valve. The prosthetic valve can be mounted on the delivery device with selected commissures of the prosthetic valve circumferentially offset from radiopaque markers on the delivery device by a second predetermined amount, the second predetermined amount resulting in implantation of the prosthetic valve with the commissures aligned with those of the native valve after deployment of the prosthetic valve using the delivery device with the radiopaque markers aligned with the guidewire in their predetermined orientation (e.g., this indicating that the markers are disposed directly behind the imaging view). The second predetermined amount can be different from the first predetermined amount described above with reference to the alignment ring 1600.

[0491] The alignment ring 1700 can be configured (e.g., constructed) to Figure 46 and 47 For example, similar to alignment ring 1600 , alignment ring 1700 can include one or more indicators 1710 a - c disposed on one or more surfaces of body 1702 of alignment ring 1700 .

[0492] like Figure 66 As shown, the alignment ring 1700 includes three indicators 1710a-c spaced apart from one another around the circumference of the alignment ring 1700. 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 may be configured to be aligned when the alignment ring is coupled to an implant holder device (e.g., as Figure 48 As shown), when the prosthetic valve is mounted on an implant holder device (e.g., such as Figure 45 and 48 When the support body 1010 is shown around the prosthetic valve, the desired orientation of the commissures is indicated. Figure 66As shown, the first indicator 1710a can be spaced apart from the first lever (eg, radial extension) 1704 by a second arc length 1706 .

[0493] In some embodiments, the alignment ring 1700 may include additional markings or indicators that indicate its intended use in aligning the prosthetic valve to be implanted during the implantation procedure using tricuspid valve imaging views. Figure 66 As shown, the alignment ring includes a first label 1708 ("View B") indicating the selected imaging view for the implant procedure. In some embodiments, the selected imaging view (View B) can be a right / left cusp overlay view as described above. In alternative embodiments, the first label 1708 can be a color code, a symbol, a numeric code, etc.

[0494] Figure 65 and 66 Different selected imaging views configured as described herein for use with a valve implantation procedure are shown. Figure 1 There are two possible embodiments of individual alignment rings for use together. However, Figure 65 Additional alignment rings are possible that are configured similarly to those shown in 66 but have different orientations of indicators (commissure markers) for different selected imaging views. In this way, in some embodiments, the user can select from a plurality of different alignment rings that are unique to a selected imaging view for an implantation procedure.

[0495] Figure 67 Another embodiment of an alignment ring 1800 is shown. The alignment ring 1800 can be similar to the other alignment rings (or ring bodies) described herein, but include multiple sets of indicators (e.g., alignment marks) for two or more implant procedures utilizing different selected imaging views. For example, the alignment ring 1800 can be configured for intended use utilizing two different fluoroscopic imaging views. Figure 67 In the example of FIG, alignment ring 1800 includes a first set of indicators 1802 and a second set of indicators 1804 that are circumferentially offset from each other. In one embodiment, first set of indicators 1802 can be used for an implantation procedure utilizing a tricuspid valve imaging view, and second set of indicators 1804 can be used for a different implantation procedure utilizing right / left cusp overlap views.

[0496] In some embodiments, the first set of indicators 1802 can have a different color than the second set of indicators 1804. In this way, indicators of different colors can correspond to different imaging views.

[0497] In other embodiments, the first set of indicators 1802 may have different markings (e.g., lines versus dots) than the second set of indicators 1804. In other embodiments, the first set of indicators 1802 may be disposed on a first side (or surface) of the alignment ring 1800, while the second set of indicators 1804 may be disposed on an opposing second side (or surface) of the alignment ring 1800.

[0498] Figure 68 Another embodiment of an alignment ring 1900 is shown. The alignment ring 1900 can be similar to the 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 markings). For example, each set of indicators 1902 can include a first (e.g., standard or base) indicator 1904, a second indicator 1906 circumferentially offset from the first indicator 1904 by a first amount (e.g., 10°), a third indicator 1908 circumferentially offset from the first indicator 1904 by a second amount (e.g., 20°), and a fourth indicator 1910 circumferentially offset from the first indicator 1904 by a third amount (e.g., 30°). In alternative embodiments, the multiple sets of indicators 1902 can include more than one set of indicators. Figure 68 Tick ​​markings are greater or lesser than those shown.

[0499] A graduated alignment ring (e.g., alignment ring 1900) having multiple graduated markings for one or more commissure positions can be useful for patients with atypical anatomy or for user-customized imaging views. For example, a user (e.g., a physician) can identify from a preoperative 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) position. Thus, a more customizable alignment ring (such as the graduated alignment ring 1900) can allow a physician to offset the prosthetic valve commissures from a more standard position. For example, the offset of the native valve commissures from the expected position can be measured in a preoperative CT, and the physician can then ask the user to offset the prosthetic valve commissures by 20° from the standard on the alignment ring and implant retainer device (e.g., using a graduated alignment ring). Figure 68 The third indicator 1908 is shown).

[0500] In this manner, methods, assemblies, and / or apparatus are provided for implanting a prosthetic heart valve at the site of a native valve with the commissures of the prosthetic heart valve circumferentially aligned with the commissures of the native valve. Thus, access to the coronary arteries may be increased.

[0501] 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 and a polymeric body, the valve mounting portion being configured to receive a radially compressed prosthetic valve thereon, the polymeric body being disposed proximate the valve mounting portion. In some embodiments, the polymeric body can include radiopaque markers configured to indicate the position of the commissures of the prosthetic valve after radially expanding the prosthetic valve via inflating the balloon of the delivery device. In some embodiments, the polymeric body can include radiopaque markers configured to align with a guidewire extending through the center of the delivery device in a predetermined orientation such that the prosthetic valve is implanted with the commissures aligned with the commissures of the native valve.

[0502] In some embodiments, the methods, assemblies and / or devices may additionally or alternatively include a method for placing and radially compressing a prosthetic valve onto a valve mounting portion of a delivery device such that selected commissures of the prosthetic valve are in a predetermined position and orientation relative to radiopaque markers of the delivery device.

[0503] In some embodiments, the methods, assemblies, and / or devices may additionally or alternatively include a method of forming and / or folding a balloon of a delivery device that results in a consistent amount of rotation of the 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, selected commissures of the prosthetic valve can be aligned circumferentially with radiopaque markers of the delivery device and / or target commissures of the native valve.

[0504] In some embodiments, the methods, assemblies and / or devices may additionally or alternatively include a delivery device configured to rotate the balloon of the delivery device with a curled (e.g., radially compressed) prosthetic valve without adversely affecting the flexure ability of the distal portion of the delivery device and / or the expansion of the balloon.

[0505] In some embodiments, the methods, assemblies and / or devices may additionally or alternatively include a delivery device having a radiopaque marker, wherein the radiopaque marker is visible under fluoroscopy and has an asymmetric shape that allows a user to determine whether the marker is positioned anterior or posterior to the fluoroscopic view (e.g., as viewed by the user).

[0506] In some embodiments, the methods, assemblies, and / or devices may additionally or alternatively include a method for rotating a distal portion of a delivery device comprising 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 guidewire extending through the delivery device, and / or a predetermined position within a selected imaging view. In some embodiments, the method for rotating can occur during a selected portion of the implantation procedure, which reduces the likelihood of clinical complications.

[0507] In some embodiments, the methods, assemblies and / or devices may additionally or alternatively include a method for rotationally aligning radiopaque markers of a delivery device with selected commissures of a native valve using a selected fluoroscopic view obtained during the implantation procedure, and deploying the prosthetic valve within the native valve using the delivery device such that the selected commissures of the prosthetic valve are circumferentially aligned with selected commissures of the native valve.

[0508] Each of the above-described features of the method, assembly and / or apparatus may be combined with any one or more of the other above-described features of the method, assembly and / or apparatus.

[0509] In this manner, the prosthetic valve can be more easily deployed at the implantation site so that the radially expanded commissures of the prosthetic valve are aligned with the commissures of the native valve, thereby avoiding placement of the commissures of the prosthetic valve that blocks the coronary arteries and / or is positioned in front of the coronary arteries. Thus, blood flow into and access to the coronary arteries can be increased.

[0510] In some embodiments, the balloon covering can be configured to surround (eg, encapsulate) a distal portion of the delivery device (eg, Figure 10 and 40 -42) of the distal portion 309 of the delivery device 300, which includes an inflatable balloon mounted (and folded) thereon during transportation and / or storage and / or during a degassing process prior to use.

[0511] For example, before crimping a prosthetic valve onto a balloon of a delivery device, the user typically performs a cyclic "degassing" process that involves pushing an inflation fluid into the balloon and then withdrawing the fluid from the balloon, such as with a syringe fluidly connected to a handle of the delivery device. The degassing process can be more efficient when the balloon is allowed to at least partially inflate. However, inflation of the balloon outside of the balloon cover can result in expansion of the balloon, which can inhibit or prevent the balloon from returning to its collapsed state (e.g., as shown in FIG. 1 ). Figure 37). The balloon cover can be configured to prevent full deployment of the balloon and / or to help the balloon return to its fully collapsed state after the inflation fluid is removed from the balloon.

[0512] Conventional balloon coverings may include a device configured to surround a distal portion of a delivery device including a balloon (e.g., distal portion 309 of delivery device 300 on which balloon 318 is mounted, such as Figure 9-11 and 40) and fit together. In some embodiments, a removable sleeve can be slid over and around the assembled balloon cover to hold (and couple) the two shell parts of the balloon cover together. When the user is ready to install or crimp the prosthetic valve around the balloon onto a delivery device (e.g., as Figure 41 ), the user can grasp the delivery device and pull to remove the sleeve from the delivery device.

[0513] However, when the delivery device includes a positioning device coupled to a distal portion of the delivery device (e.g., Figure 54 and 55 The positioning device 1100 shown coupled to the distal portion 309 of the delivery device 300, or Figure 49 57 ). When the positioning device 1072 is shown coupled to the distal portion of the delivery device, the user can grasp the positioning device during removal of the sleeve from the balloon covering. For example, the user can grasp the positioning device with one hand and then use the other hand to slide the sleeve off the balloon covering and off the distal end of the delivery device. 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). As a result, the prosthetic valve can then be mounted on the balloon with an inappropriate circumferential orientation relative to the markers, which can result in misalignment of the commissures of the prosthetic valve with the commissures at the implantation site or the native valve (e.g., during the implantation procedure, as explained above with reference to FIG57 ).

[0514] To address such issues, a balloon cover for a balloon mounted on and around a distal portion of a delivery device may include first and second housing members, each housing member having a narrower first portion configured to receive (and enclose therein) the distal portion of the delivery device including the balloon, and a wider second portion configured to receive (and at least partially enclose therein) a positioning device. In this manner, the second portion may surround the positioning device and prevent a user from directly contacting or grasping the positioning device, thereby avoiding any unwanted movement (e.g., rotation) of the positioning device relative to the delivery device during removal of the balloon cover from the delivery device.

[0515] Figure 69-76B108-114 illustrate embodiments of a balloon covering configured to cover a distal portion of a delivery device (e.g., distal portion 309 of delivery device 300, e.g., balloon 318) including an inflatable balloon mounted thereon. Figure 69 、 72 -76B and 108-114) and a positioning device (eg, positioning device 1100, such as shown in FIG. 110) coupled to a distal portion of the delivery device proximal to the valve mounting portion of the delivery device. Figure 69 、 72 -76B and 108-114).

[0516] Figure 69-75C An exemplary embodiment of such a balloon covering (or balloon covering assembly) 2000 is shown, comprising a first covering portion 2001 and a second covering portion 2003 ( Figure 72 and 73 The first covering portion 2001 is configured to cover at least a portion of the distal portion of the delivery device including the balloon, and the second covering portion 2003 is configured to cover the positioning device. The balloon covering 2000 may include a first shell member 2002 and a second shell member 2004 configured to cooperatively engage with each other and be removably coupled to each other. For example, the first shell member 2002 and the second shell member 2004 may include the outer shell 2006 of the balloon covering 2000 and / or form two halves of the outer shell 2006 of the balloon covering 2000 ( Figure 69 ).

[0517] The outer shell 2006 and the balloon cover 2000 are Figure 69 is shown in exploded configuration in the exploded view of Figure 72-75C 1 is shown in an assembled configuration in the various views of the drawings. Figure 70 The first housing member 2002 is shown detached from the remainder of the balloon covering 2000. However, because the first housing member 2002 and the second housing member 2004 can be configured identically (e.g., identically formed) in some embodiments, Figure 70 The first housing member 2002 shown may alternatively be the second housing member 2004. In addition, Figures 71A-71C The mating interface 2008 between the first housing member 2002 and the second housing member 2004 is shown. Figure 71C ) and the associated mating interface features or components of the first housing member 2002 and the second housing member 2004 ( Figures 71A-71C ) in the detail view.

[0518] 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 each other (e.g., formed as one piece). In some embodiments, the second portion 2012 can have a second width 2018 (e.g., greater than the first width 2016) of the first portion 2010. Figure 70 ), the width being defined in a radial direction relative to a central longitudinal axis 2014 of the balloon covering 2000 (which, when assembled and coupled about a delivery device, can be coaxial with a central longitudinal axis of the delivery device). In some embodiments, the first width 2016 and the second width 2018 can be diameters.

[0519] When the first housing member 2002 and the second housing member 2004 are assembled together (e.g., in a mating engagement), the first portion 2010 of the first housing member 2002 and the second housing member 2004 can form the first covering portion 2001 and define an elongated cavity 2020 (which, in some embodiments, can be referred to as a lumen). The cavity 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., balloon 318 of distal portion 309, as shown). Figure 69 and 72 -75C ).

[0520] For example, the first portion 2010 of the first housing member 2002 (and similarly, the second housing member 2004) includes an outer surface 2022 ( Figure 69 and 70 ) and inner surface 2024( Figure 70 Inner surface 2024 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 first portion 2010 of another (e.g., second) housing member to form balloon covering 2000. In some embodiments, inner surface 2024 can be a flat surface.

[0521] The first portion 2010 can further include a recess 2026 that is recessed (toward the outer surface 2022) into the inner surface 2024. The recesses 2026 of the first housing member 2002 and the second housing member 2004 can together form the cavity 2020. Thus, each recess 2026 of each of the first housing member 2002 and the second housing member 2004 can define a half cavity portion 2021 ( Figure 70 ).

[0522] 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 section 2028, a proximal section 2030, and an intermediate section 2032 ( Figure 70 ).

[0523] In some embodiments, distal section 2028 can be shaped (e.g., configured) to receive a balloon (e.g., balloon 318) and a portion of a balloon-covered delivery device. Figure 69-75C In the illustrated embodiment, the distal section 2028 can be shaped to receive a portion of the nose cone 322 and the distal portion 332 of the balloon 318 covering the distal shoulder 326 of the delivery device 300 .

[0524] In some embodiments, the intermediate section 2032 can be shaped (eg, configured) to receive the intermediate portion 335 of the balloon and the portion of the delivery device 300 (eg, the valve mounting portion 324 ) that the intermediate portion 335 covers.

[0525] In some embodiments, the proximal section 2030 can be shaped (e.g., configured) to receive at least a distal portion of the proximal portion 333 of the balloon 318. In some embodiments, a more proximal portion of the proximal portion 333 of the balloon 318 can extend into the second portion 2012 of the first housing member 2002 or the second housing member 2004 ( Figure 70 and 72 In other embodiments, the proximal section 2030 can be shaped to receive the entire proximal portion 333 of the balloon 318 .

[0526] In this manner, the shape or profile of the recess 2026 can vary along a first length 2034 of the first portion 2010 that extends in an axial direction relative to the central longitudinal axis 2014 ( Figure 70 ). For example, Figure 70 As shown, the middle section 2032 is narrower than each of the distal section 2028 and the proximal section 2030. In some embodiments, the width of the middle section 2032 is constant along most of the length of the middle section 2032.

[0527] In other embodiments, each recess 2026 can include a distal segment 2028 and a proximal segment that can be similar to the intermediate segment 2032 and extend from the distal segment 2028 to the second portion 2012. In such embodiments, the proximal segment can be 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., the valve mounting portion 324). In some embodiments, the proximal segment can be further configured to receive the proximal portion 333 of the balloon 318 that may not have a diameter portion wider than the intermediate portion 335 when disposed within the balloon cover 2000. Figures 108-114 Such an exemplary embodiment is shown in FIG, as further described below.

[0528] In some embodiments, the first length 2034 of the first portion 2010 can be longer than the second length 2036 of the second portion 2012 .

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

[0530] In some embodiments, the second length 2036 of the second portion 2012 can be selected based on the length and / or size of a positioning device (e.g., positioning device 1100) contained within the second portions 2012 of the first and second housing members 2002, 2004 when the second portions 2012 of the first and second housing members 2002, 2004 are coupled together in a mating engagement. For example, in some embodiments, the second length 2036 can be the same as or longer than the length of the positioning device 1100. In some embodiments, the second length 2036 can be shorter than the length of the positioning device 1100, but long enough to cover enough of the positioning device (e.g., a majority or a wider or larger diameter portion of the positioning device) to discourage or deter a user from grabbing onto the positioning device 1100.

[0531] When the first housing member 2002 and the second housing member 2004 are assembled to each other (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 the second cover portion 2003 and define a cavity 2038 ( Figure 69 and 72 -75A). Cavity 2038 can be configured to receive a positioning device (e.g., positioning device 1100, such as a positioning device 1100) mounted on distal portion 309 of delivery device 300 proximal to valve mounting portion 324 of distal portion 309. Figure 69 and 72-75C).

[0532] The inner surface of the wall of the second portion 2012 can define a half cavity portion 2040 ( FIG. 70 ) of the cavity 2038 . Figure 70 As shown, 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 (e.g., Figure 69-75C ). The fourth wall 2056 can be relatively planar and arranged perpendicular to the first wall 2050. In some embodiments, the fourth wall 2056 can define an opening (which may 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).

[0533] In other embodiments, as shown below Figure 76A and 76B To further explain, the second portion 2012 may not include the fourth wall 2056 (and the opening 2046 ), and instead the second wall 2052 and the third wall 2054 may be continuous with each other (eg, forming one continuously curved wall forming a complete semi-cylinder).

[0534] Each wall of the second portion 2012 may include an inner surface and an outer surface. For example, the first wall 2050 may have a first inner surface 2042, the second wall 2052 may have a second inner surface 2044, the third wall 2054 may have a third inner surface 2043, and the fourth wall 2056 may have a fourth inner surface 2048 ( Figure 70 The first inner surface 2042 , the second inner surface 2044 , the third inner surface 2043 , and the fourth inner surface 2048 may define a half-cavity portion 2040 .

[0535] like Figure 69 and 70 As shown, in some embodiments, the recess 2026 can extend to the first inner surface 2042. In this manner, the recess 2026 can be continuous from the first inner surface 2042 to the distal end of the first portion 2010.

[0536] In some embodiments, the second inner surface 2044 and the third inner surface 2043 are both curved and together form a semi-cylindrical shape of the second portion 2012. In some embodiments, the second inner surface 2044 and the first inner surface 2042 are separated from each other by an opening 2046 and connected together at the proximal end of the second portion 2012 by a fourth inner surface 2048.

[0537] 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 (eg, Figure 71C ). Mating surfaces 2058 can be formed along edges of the first wall 2050, the second wall 2052, and the third wall 2054.

[0538] In some embodiments, the mating surface 2058 of the second portion 2012 can be continuous (and / or in the same plane) with the inner surface 2024 of the first portion 2010. In this manner, the inner surface 2024 and the mating surface 2058 can form the entire mating surface of the first or second housing member 2002, 2004.

[0539] 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) and a 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). Figure 71A A detailed view of a first portion of the mating surface 2058 including the protrusion 2060 is shown in FIG. Figure 71B A detailed view of a second portion of the mating surface 2058 including the groove 2062 is shown in FIG. The protrusion extends outwardly from the mating surface 2058, and the groove 2062 is recessed into the mating surface 2058.

[0540] Figure 71C Detailed view of the mating interface 2008 between the protrusion 2060 of the first housing member 2002 (e.g., on a first portion of the mating surface 2058 of the first housing member 2002) and the recess 2062 of the second housing member 2004 (e.g., on a second portion of the mating surface 2058 of the second housing member 2004). Figure 71CAs shown, in some embodiments, the corresponding mating surfaces 2058 of the corresponding second portions 2012 of the first and second shell members 2002, 2004 can be positioned against each other (e.g., in face-to-face contact), and the protrusion 2060 of the first shell member 2002 can extend into (and mate with, or engage with) the recess 2062 of the second shell member 2004. The reverse of this mating engagement can occur at a second portion of the mating surfaces 2058 of the first and second shell members 2002, 2004 (e.g., on the opposite side of the balloon covering 2000, the protrusion 2060 of the second shell member 2004 can extend into and mate with the recess 2062 of the first shell member 2002).

[0541] In other embodiments, the mating interface 2008 between the first housing member 2002 and the second housing member 2004 can be configured differently with different interlocking or butting mating features (e.g., such as other lock-and-key or complementary features). In some embodiments, the mating interface 2008 between the first housing member 2002 and the second housing member 2004 can have different protruding and recessed interlocking features, such as protrusions of different shapes (e.g., triangular in cross-section or a series of spaced-apart protrusions) and (one or more) correspondingly shaped grooves or recesses.

[0542] The configuration of the mating interface 2008 as described above can prevent the first housing member 2002 and the second housing member 2004 from sliding past each other when the assembled balloon covering 2000 is grasped or manipulated by a user.

[0543] Once assembled in a mating engagement (e.g. Figure 72-75C As shown), the first housing member 2002 and the second housing member 2004 can be held or coupled together via the coupling element (e.g., so that they cannot be pulled apart from each other). Figure 69 、 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 mating first portions 2010 of the first and second housing members 2002, 2004. For example, the sleeve 2064 can be configured to hold the first and second housing members 2002, 2004 in mating engagement with each other. Thus, the balloon covering 2000 can be held together (and mounted) over and around the distal portion 309 of the delivery device.

[0544] As mentioned above and Figure 72 and73 30. As shown, when assembled together, the first portion 2010 of the first and second housing members 2002, 2004 can cover and surround a portion of the distal portion 309 of the delivery device and the balloon 318. In some embodiments, the portion of the delivery device covered by the first portion 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 the portion of the inner shaft 308 around which the proximal portion 333 of the balloon 318 is disposed, as well as the portion of the balloon 318 covering these portions of the delivery device. Figure 72 ).

[0545] In addition, if Figure 72 and 73 As shown, when assembled together, the first shell member 2002 and the second portion 2012 of the second shell member 2004 can cover and surround a positioning device (e.g., positioning device 1100) mounted on the distal portion 309 of the delivery device proximal to the valve mounting portion 324 of the distal portion 309 of the delivery device.

[0546] In some embodiments, the first housing member 2002 and the second portion 2012 of the second housing member 2004 can cover and surround the entire positioning device 1100. In other embodiments, the first housing member 2002 and the second portion 2012 of the second housing member 2004 can cover and surround a majority of the positioning device 1100 (e.g., all but the most proximal portion, such as Figure 72 and 72 shown).

[0547] When assembled together, the first housing member 2002 and the second portion 2012 of the second housing member 2004 can form a closed distal end 2066 ( Figure 72 、 73 and 75A) and open proximal end 2068 ( Figure 72-75C For example, the closed distal end 2066 can be formed by the outer surface 2070 of the first wall 2050 of the first housing member 2002 and the second housing member 2004.

[0548] 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 housing member 2002 and / or the second housing member 2004.

[0549] In addition, in some embodiments (such as Figures 74-75CAs shown), the open proximal end 2068 can be formed by the edge portion 2072 of the second wall 2052 and the third wall 2054 of each of the first shell member 2002 and the second shell member 2004.

[0550] In other embodiments, the proximal end 2068 can be at least partially closed. For example, in such embodiments, the edge portion 2072 can extend radially inward to form a partial (eg, not completely surrounding) wall.

[0551] The first portion 2010 of the first and second housing members 2002 and 2004 extends distally from the closed distal end 2066 in an axial direction.

[0552] The outer surfaces of the walls of the second portion 2012 of the first and second shell members 2002, 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 when sliding the sleeve 2064 off the first portion 2010 (so that the balloon cover 2000 can be removed from the delivery device).

[0553] When the first housing member 2002 and the second portion 2012 of 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 by the oppositely disposed curved walls (eg, the second wall 2052, such as the first housing member 2002 and the second housing member 2004). Figure 74 shown).

[0554] like Figure 75B and 75C As shown, the inner diameter 2074 and the inner height 2076 can be selected based on the maximum size of the positioning device contained within the cavity 2038. For example, the inner diameter 2074 and the inner height 2076 can be selected so that the flange portion 1112 of the positioning device 1100 fits within the cavity 2038 without contacting (e.g., being spaced apart from) the second inner surface 2044 and the third inner surface 2043 of the first and second housing members 2002, 2004. For example, the inner diameter 2074 can be larger than the outer diameter of the flange portion 1112.

[0555] 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 FIG. Figure 75C As shown, one or more portions of the flange portion 1112 of the positioning device 1100 (eg, the extension portion 1114 ) can extend into one of the openings 2046 (eg, between the fourth inner surface 2048 and the outer surface of the fourth wall 2056 ).

[0556] Thus, when a user grasps the exterior of the second covering portion 2003 (e.g., to remove the sleeve 2064), any movement of the balloon covering 2000 does not result in movement of the positioning device 1100 relative to the delivery device because the balloon covering 2000 does not directly contact the positioning device 1100. For example, if the balloon covering 2000 is rotated, that rotation does not result in rotation of the positioning device 1100, thereby maintaining the positioning device in a designated and intended circumferential position relative to the delivery device. This can enable a prosthetic valve to be mounted on a valve mounting portion of a delivery device in a predetermined circumferential orientation relative to a radiopaque marker on the delivery device, as discussed herein (e.g., as described above with reference to Figure 57 discussed).

[0557] In some embodiments, as Figures 74-75C As shown, the inner height 2076 can be smaller than the inner diameter 2074. Correspondingly, the second cover portion 2003 can have an outer height 2078 ( 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. Therefore, 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 ).

[0558] In some embodiments, the configuration of the opening 2046 in the fourth wall 2056 of the first and second housing members 2002 , 2004 can result in a reduced inner height 2076 and outer height 2078 .

[0559] In some embodiments, the opening 2046 can also allow a user to visualize the positioning device 1100 and the distal portion 309 of the delivery device 300, which can allow for easier assembly of the balloon covering 2000 around the delivery device.

[0560] In other embodiments, the second cover portion 2003 may be cylindrical, and the first housing member 2002 and the second housing member 2004 may have walls that completely enclose the positioning device without any openings therein. Figure 76A and 76B Another exemplary embodiment of a balloon covering 2100 is shown that includes a first shell member 2102 and a second shell member 2104 that are configured to cooperatively engage and removably couple to each other.

[0561] The first shell member 2102 and the second shell member 2104 can be configured similarly to the first shell member 2002 and the second shell member 2004 of the balloon covering 2000 (FIGS. 69-75C), except that the first shell member 2102 and the second shell member 2104 do not include the opening 2046 and the inner diameter 2106 and the outer diameter 2108 of the second covering portion 2110 (similar to the second covering portion 2003) are constant around the circumference of the second covering portion 2110 ( Figure 76B ). Thus, second cover portion 2110 does not have a reduced height (compared to balloon cover 2000). Thus, compared to balloon cover 2000 ( Figure 69-75C ) compared to the balloon cover 2100 ( Figure 76A and 76B ) can increase packaging space.

[0562] Figures 108-114 Another embodiment of a balloon covering 2600 is shown that is configured to cover a portion of a distal portion of a delivery device (e.g., distal portion 309 of delivery device 300) including an inflatable balloon (e.g., balloon 318) mounted thereon and a positioning device coupled to the distal portion of the delivery device proximal to the valve mounting portion of the delivery device. The balloon covering 2600 may be similar to Figure 69-75C The balloon cover 2600 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, thereby causing unpredictable rotation of the prosthetic heart valve (and therefore uncertainty in the positioning of the prosthetic valve commissures relative to the native valve commissures) during valve deployment at the implantation site.

[0563] The balloon cover 2600 includes a first cover portion 2601 configured to cover at least a portion of the distal portion of the delivery device including the balloon and a second cover portion 2603 configured to cover the positioning device. The balloon cover 2600 may include a first shell member 2602 and a second shell member 2604 configured to cooperatively engage and removably couple to each other. Figure 110 and 113 For example, the first shell member 2602 and the second shell member 2604 may comprise the outer shell 2606 of the balloon covering 2600 and / or form two halves of the outer shell 2606 of the balloon covering 2600 ( Figure 110 ).

[0564] The outer shell 2606 and the balloon cover 2600 are Figure 110 is shown in exploded configuration in the exploded view of Figure 108 、 109 , 111 and 113 are shown in assembled configuration. Figure 113 A cross-sectional view of the balloon cover 2600 is shown, and Figure 114 One of the housing members (eg, first housing member 2602) is shown disposed about the delivery device.

[0565] In some embodiments, the first housing member 2602 and the second housing member 2604 may have the same Figures 71A-71C The mating interface depicted is similar or identical to mating interface 2008 .

[0566] Each of first and second housing members 2602, 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, first and second portions 2610, 2612 of one of first and second housing members 2602, 2604 can be continuous with each other (e.g., formed as one piece). Similar to balloon covering 2000, second portion 2612 of balloon covering 2600 can have a greater width than first portion 2610.

[0567] When the first and second housing members 2602, 2604 are assembled together (e.g., to mating engagement), the first portions 2610 of the first and second housing members 2602, 2604 can form the first cover portion 2601 and define the elongated cavity 2620 ( Figure 110 and 113). Cavity 2620 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., balloon 318 of distal portion 309, such as Figure 110 、 113 and 114 ) at least a portion (e.g., in some embodiments, a majority).

[0568] For example, the first portion 2610 of the first housing member 2602 (and similarly, the second housing member 2604) includes an outer (radially outwardly facing) surface 2622 ( Figure 110 、 112 and 113) and inner (radially inwardly facing) surface 2624 ( Figure 110 and 114 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 first portion 2610 of another (e.g., second) housing member to form balloon covering 2600. In some embodiments, inner surface 2624 can be a flat surface.

[0569] In some embodiments, one of the housing members (the second housing member 2604, such as Figure 110 and 112 may include a hole or window 2660 disposed through the outer surface 2622 and the inner surface 2624 and positioned so that the marking 600 on the distal shoulder (or other marking on the distal portion of the delivery device) can be visualized by a user when the balloon covering is coupled to the delivery device, as described herein.

[0570] The first portion 2610 may further include (toward the outer surface 2622, Figure 110 and 114 ) is recessed into the inner surface 2624. The recesses 2626 of the first housing member 2602 and the second housing member 2604 can together form a cavity 2620.

[0571] Each recess 2626 can be shaped to receive a portion of the distal portion 309 of the delivery device. For example, each recess 2626 can include a distal section 2628 and a proximal section 2630 ( Figure 110 In some embodiments, distal segment 2628 can be shaped (eg, configured) to receive a balloon (eg, balloon 318) and a portion of a balloon-covered delivery device. Figures 108-114 In the embodiment shown, the distal section 2628 can be shaped to receive a portion of the nose 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).

[0572] In some embodiments, the proximal section 2630 can be shaped (e.g., configured) to receive the middle portion 335 of the balloon and the portion of the delivery device 300 (e.g., the valve mounting portion 324) covered by the middle portion 335. In some embodiments, the proximal section 2630 can also be shaped to receive at least the distal portion of the proximal portion 333 of the balloon 318, but Figures 108-114 In the embodiment shown, the proximal portion 333 of the balloon 318 can have the same profile or diameter as the middle portion 335. Thus, the proximal section 2630 can have a constant or relatively constant width along its length (or a majority of its length) from the distal section 2628 to the second portion 2612 of the housing member. In other embodiments, each recess 2626 can be shaped similar to Figure 69-75C The depression 2026 of the balloon covering 2000 is shown.

[0573] In this manner, the shape or profile of the recess 2626 can vary along the length of the first portion 2610. For example, Figure 110 、 113 As shown in Figures 114 and 114, the proximal section 2630 is narrower than the distal section 2628.

[0574] 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 FIG. Figure 69-75C Descriptive.

[0575] The second portion 2012 of each of the first shell member 2602 and the second shell member 2604 can be configured (sized and formed) based on the length and / or size of the positioning device (e.g., the positioning device 1100) to be contained within the second portion 2612 of the first shell member 2602 and the second shell member 2604 when the second portion 2612 of the first shell member 2602 and the second shell member 2604 are coupled together in a mating engagement.

[0576] When the first housing member 2602 and the second housing member 2604 are assembled to each other (e.g., coupled together in a mating engagement), the second portions 2612 of the first housing member 2602 and the second housing member 2604 can form the second cover portion 2603 and define the cavity 2638 ( Figure 108 and 111-114). Cavity 2638 can be configured to receive a positioning device (e.g., positioning device 1100, as shown in Figures 108-114) mounted on the distal portion 309 of the delivery device 300 proximal to the valve mounting portion 324 of the distal portion 309. In some embodiments, the overall dimensions of cavity 2638 can be similar to cavity 2038 of balloon cover 2000, as described above, except for one or more cavities 2652 described further below.

[0577] Similar to the balloon cover 2000 ( Figure 69-75C ), the inner surface of the wall of the second portion 2612 can define a semi-cavity portion of the cavity 2638. In some embodiments, the second portion 2612 of the second shell member 2604 can be configured the same as or similar to the second portions 2012 of the first shell member 2002 and the second shell member 2004 of the balloon covering 2000 (see above). Figure 69-75C ). However, the second portion 2612 of the first housing member 2602 can have a first wall 2650 (a wall connected to 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 that are shaped to receive and retain a portion of the flange portion 1112 of the positioning device 1100 therein ( Figure 110 、 113 In some embodiments, the second portion 2612 of the first housing member 2602 may include one or more protruding wall portions 2654 that are part of the first wall 2650 or extend from the first wall 2650 to protrude into the cavity 2638 and form one or more cavities 2652 ( Figure 108 、 110 , 113 and 114).

[0578] By configuring the first wall 2650 of the second portion 2612 of the first housing member 2602 with one or more cavities 2652, the positioning device 1100 and the balloon covering 2600 are prevented from rotating relative to each other when the balloon covering 2600 is coupled to the delivery device and surrounds the positioning device 1100. Thus, twisting of the balloon 318 can be avoided.

[0579] In some embodiments, one of the shell portions of any other balloon covering described herein (e.g., reference Figures 69-86) can have a second portion including 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 Descriptive.

[0580] Return 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 covering 2000, the second portion 2612 of the balloon covering 2600 can define an opening 2646.

[0581] Once assembled in a mating engagement (e.g. Figure 108 、 109 111-113 ), first housing member 2602 and second housing member 2604 can be held or coupled together (e.g., so that they cannot be pulled apart) via a coupling element. In some embodiments, coupling element can be configured as sleeve 2664. Sleeve 2664 can be configured the same as or similar to sleeve 2064 of balloon covering 2000.

[0582] As described above, when assembled together, the first and second housing members 2602, 2604 can cover and surround a portion of the distal portion 309 of the delivery device and the balloon 318 ( 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 may 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 the portion of the balloon 318 covering these portions of the delivery device ( Figure 113 and 114 ).

[0583] Similar to the reference above Figure 69-75C As described, the outer surfaces of the walls of the first shell member 2602 and the second portion 2612 of the second shell member 2604 can form the second covering portion 2603 of the balloon covering 2600 and can provide a surface for the user to grasp and / or hold when sliding the sleeve 2664 off the first portion 2610 (so that the balloon covering 2600 can be removed from the delivery device) without having to grasp the positioning device 1100.

[0584] As above reference Figures 38-41As described, the distal 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 the prosthetic valve is mounted in a radially compressed state around the valve mounting portion 324 of the delivery device 300, the outer shaft 304 and the intermediate shaft (e.g., balloon shaft) 306 can be axially moved relative to each other such that the distal tip portion 900 is disposed above the proximal portion 333 of the balloon 318. Thus, the distal tip portion 900 can serve as a proximal shoulder proximal to the valve mounting portion 324 and prevent the radially compressed prosthetic valve from moving proximally in the axial direction during advancement of the distal portion of the delivery device to the target implantation site.

[0585] As previously described, prior to crimping the prosthetic valve about the valve mounting portion 324, the balloon 318 can undergo a cyclic degassing process whereby an inflation fluid is introduced into the balloon and then withdrawn from the balloon. The process of introducing inflation fluid into the balloon 318 and then withdrawing the inflation fluid can be repeated one or more times as desired. During the degassing process, the distal tip portion 900 is typically positioned proximal to the balloon 318 (e.g., away from and away from the proximal portion 333 of the balloon 318) to facilitate the flow of inflation fluid into the proximal portion 333 of the balloon 318. In some embodiments, the degassing process can be performed while the balloon 318 is contained within a balloon covering. Following the degassing process, the balloon covering can be removed from the balloon and the outer shaft 304 can be moved axially relative to the intermediate shaft 306 (and the inner shaft 308) to a more distal position extending above the proximal portion 333 of the balloon 318 (e.g., away from and away from the proximal portion 333 of the balloon 318). Figure 41 As the distal tip portion 900 moves distally over the proximal portion 333 , residual fluid in the proximal portion 333 of the balloon from the degassing process may be pushed distally into the middle portion 335 and distal portion 332 of the balloon 318 .

[0586] As described above, to accommodate this residual fluid without increasing the crimp profile of the prosthetic valve on the delivery device, a radial depression 334 can be initially formed in the distal portion 332 of the balloon 318 (e.g., before the distal tip portion 900 is moved over the proximal portion 333 of the balloon 328). Figure 40 When the residual inflation fluid in the proximal portion 333 of the balloon 318 is "squeezed" or pushed into the distal portion 332 of the balloon 318 by advancing the distal tip portion 900, the displaced residual fluid can move the distal portion 332 of the balloon 318 from Figure 40 The radial depression shown expands to Figure 41 shown (and in Figure 40324). Thus, undesired expansion of the intermediate portion 324, which could expand the curled profile of the prosthetic valve, can be avoided.

[0587] Various techniques and mechanisms can be used to achieve Figure 40 The balloon shape shown includes a balloon covering having an inner lumen shaped to create the desired shape of the balloon (eg, radial depression 334).

[0588] Figure 77-83B An exemplary embodiment of a balloon covering 2200 is shown that is configured to receive (and cover) a distal portion of a delivery device (e.g., distal portion 309 of delivery device 300, e.g., balloon 318) that includes an expandable balloon (e.g., balloon 318) mounted thereon. Figure 77 In some embodiments, the balloon cover 2200 is configured to additionally receive a positioning device (e.g., positioning device 1100, such as shown) coupled to a distal portion of the delivery device proximal to the valve mounting portion of the delivery device. Figures 53-55 and 77).

[0589] More specifically, the balloon covering 2200 is configured to receive and produce a particular final shape of the balloon 318 (e.g., such as Figure 40 The shape shown includes radial depressions 334). For example, Figure 77 is an exploded view of the balloon cover 2200 configured to be assembled around the distal portion 309 of the delivery device 300. Figure 83A and 83B A cross-sectional view of the assembled balloon cover 2200 is shown in FIG. As described more fully below, the balloon cover 2200 may be similar to the above referenced Figure 69-75C Balloon covering 2100 is depicted, except that a recessed sleeve is added that is configured to receive distal portion 332 of balloon 318 and a first cavity (formed by a recess in the shell member) that is configured to receive intermediate portion 335 and proximal portion 333 of balloon 318 .

[0590] like Figure 77 and 83A As shown, a balloon covering (or balloon covering assembly) 2200 includes a first covering portion 2201 configured to cover at least a portion of a distal portion of a delivery device including a balloon. The balloon covering 2200 can further include a second covering portion 2203 ( Figure 77 and 83A ).

[0591] Balloon covering 2200 may include first and second shell members 2202, 2204 (similar to first and second shell members 2002, 2004 of balloon covering 2000) configured to cooperatively engage and removably couple to each other. For example, first and second shell members 2202, 2204 may comprise two halves of shell 2206 of balloon covering 2200 ( Figure 77 、 83A and 83B).

[0592] The balloon cover 2200 may further include a recessed sleeve 2240 (which may also be referred to as a recessed cap, member, or tube). The recessed sleeve 2240 may be configured to form the shape (e.g., a recessed or concave shape) of a portion of the balloon of the delivery device (e.g., the radial recess 334 in the distal portion 332 of the balloon 318). Figure 78-81B The various views of FIG. 2240 further describe the recessed sleeve 2240 in detail.

[0593] In some embodiments, the balloon covering 2200 can further include a coupling element, which in some embodiments can be a tubular sleeve (e.g., an outer sleeve) 2264 configured to cover at least a portion of the recessed sleeve 2240 and to recess one or more recessed members 2256 of the recessed sleeve 2240 in a radially inward direction toward the central longitudinal axis 2214 so as to form a negative recess in one or more portions of the balloon.

[0594] In some embodiments, the sleeve 2264 can be further configured to retain the first housing member 2202 and the second housing member 2204 in mating engagement with each other (e.g., as Figure 83A and 83B ). Sleeve 2264 can be the same as or similar to sleeve 2064 described above.

[0595] Balloon cover 2200 Figure 77 The exploded view of the Figure 83A and 83B are shown in an assembled configuration. Figure 82 The first shell member 2202 is shown detached from the rest of the balloon covering 2200. However, because the first shell member 2202 and the second shell member 2204 can be configured identically (e.g., identically formed) in some embodiments, Figure 82 The first housing member shown may alternatively be the second housing member 2204. Additionally, different views of the recessed sleeve 2240 are shown in isolation in Figures 78-81B.

[0596] like Figure 77 and 82 As shown, in some embodiments, each of the first housing member 2202 and the second housing member 2204 includes a first portion (e.g., a first housing portion) 2210 and a second portion (e.g., a second housing portion) 2212. In some embodiments, for each of the first housing member 2202 and the second housing member 2204, the first portion 2210 and the second portion 2212 can be continuous with each other.

[0597] In some embodiments, the second portion 2212 can have a second width 2218 that is greater than the first width 2216 of the first portion 2210, the width being defined in a radial direction relative to the central longitudinal axis 2214 of the balloon covering 2200 (when assembled and coupled about a delivery device, the central longitudinal axis 2214 can be coaxial with the central longitudinal axis of the delivery device). In some embodiments, the first width 2216 and the second width 2218 can be diameters.

[0598] When the first shell member 2202 and the second shell member 2204 are assembled together (e.g., in mating engagement), the first portion 2210 of the first shell member 2202 and the second shell member 2204 can form a portion of the first cover portion 2201 (e.g., which also includes a recessed sleeve 2240, as further described below) and define an elongated cavity 2220 (which in some embodiments can be referred to as a lumen). Cavity 2220 ( Figure 77 、 83A and 83B) 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., balloon 318 of distal portion 309, such as Figure 77 as shown) (e.g., in some embodiments, the middle portion and the proximal portion).

[0599] For example, the first portion 2210 of the first housing member 2202 (and similarly, the second housing member 2204) includes an outer surface 2222 and an inner surface 2224 ( Figure 77 and 82 ). The inner surface 2224 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 2210 of another (e.g., second) shell member to form the balloon covering 2200. In some embodiments, the inner surface 2224 can be a flat surface.

[0600] The first portion 2210 may further include a recess 2226 (recessed into the inner surface 2224 toward the outer surface 2222) Figure 82The recesse...

Claims

1. A balloon cover for a delivery device, comprising: a first shell member and a second shell member configured to cooperatively engage one another, wherein each of the first shell member and the second shell member includes a first portion and a second portion, the second portion having a greater width than the first portion, the width being defined in a direction perpendicular to a central longitudinal axis of the balloon covering; wherein the first portion of the first housing member and the first portion of the second housing member define a first lumen configured to receive a distal portion of the delivery device and at least a portion of an expandable balloon mounted on the distal portion of the delivery device; wherein the second portion of the first housing member and the second portion of the second housing member define a second lumen configured to receive a positioning device mounted on the distal portion of the delivery device proximal to the valve mounting portion of the distal portion of the delivery device; and The second portion of the first shell member includes one or more protruding wall portions, which protrude into the second cavity and form one or more cavities, and the one or more cavities are configured to receive and retain a portion of the positioning device therein so as to prevent the positioning device and the balloon covering from rotating relative to each other.

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

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

4. A balloon covering according to claim 2 or claim 3, wherein the recess includes a distal segment and a proximal segment, wherein the distal segment is formed to receive the distal portion of the balloon covering the distal shoulder of the delivery device, and the proximal segment is formed to receive the middle portion of the balloon covering the valve mounting portion of the delivery device. The balloon covering of claim 4 , wherein the proximal section is narrower than the distal section.

6. The balloon covering of claim 4 or claim 5, wherein the distal section is further shaped to receive a portion of a nose cone of the delivery device, the nose cone being disposed at the distal end of the delivery device.

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

8. A balloon covering according to claim 7, wherein the inner surface of the recessed member includes a second protrusion arranged adjacent to the free end, the second protrusion being formed to form the negative radial recess in the distal portion of the balloon, and further including a sleeve, the sleeve being configured to be positioned around the first part of the first shell member and the first part of the second shell member so that the first shell member and the second shell member remain in mating engagement with each other, and wherein the free end of each recessed member is configured to move radially inward so that when the sleeve is positioned around the first part of the first shell member and the first part of the second shell member, the first protrusion is aligned with the outer surface of the first part of the corresponding first shell member or second shell member.

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

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

11. The balloon covering according to claim 2 or claim 3 further includes a recessed sleeve configured to receive a portion of each of the first portion of the first shell member and the first portion of the second shell member and couple around them, and wherein the recessed sleeve includes one or more recessed members, each of the one or more recessed members including a free end that is not attached to the remainder of the recessed sleeve and is configured to form a negative radial recess in the portion of the balloon surrounded by the recessed sleeve.

12. A balloon covering according to claim 11, wherein the recessed sleeve includes a first portion, a second portion and a third portion, the first portion being configured to receive a distal portion of the delivery device, the second portion being configured to receive a distal portion of the balloon, the third portion being configured to receive each of the first portion of the first shell member and the first portion of the second shell member and coupled around them, the second portion being arranged between the first portion and the third portion of the recessed sleeve, wherein the one or more recessed members are disposed in the second portion of the recessed sleeve, and wherein the one or more recessed members are configured to form the negative radial recess in the distal portion of the balloon.

13. The balloon covering according to claim 12 further includes a tubular sleeve, which is configured to be positioned around the second portion and the third portion of the recessed sleeve and the first portion of the first shell member and the first portion of the second shell member, so that the first shell member and the second shell member remain in mating engagement with each other and the free end of each of the one or more recessed members is radially recessed inward.

14. A balloon covering according to any one of claims 1-13, wherein the second portion of each of the first shell member and the second shell member is defined by a first wall and two curved walls forming the distal end of the second portion, wherein the central longitudinal axis of the balloon covering is perpendicular to the first wall, and wherein the two curved walls extend in an axial direction from the first wall to the proximal end of the second portion.

15. A balloon covering according to claim 14, wherein the second portion of each of the first shell member and the second shell member is further defined by a fourth wall, the fourth wall extending between the two curved walls in the circumferential direction and arranged perpendicular to the first wall, the fourth wall defining an opening, wherein the second cavity has a diameter and a height, the height being defined between the respective inner surfaces of the fourth wall of the first shell member and the fourth wall of the second shell member, and the diameter being defined between the first curved wall of the two curved walls of the first shell member and the second curved wall of the two curved walls of the second shell member, and wherein the height is less than the diameter.

16. A balloon covering according to claim 14 or claim 15, wherein the second portion of each of the first shell member and the second shell member includes a mating surface formed along the edges of the first wall and the two curved walls, the mating surface including a first mating element extending along the first portion of the mating surface and a second mating element extending along the second portion of the mating surface, the first portion and the second portion of the mating surface being arranged on opposite sides of the second portion of the corresponding first shell member and the second shell member relative to the central longitudinal axis.

17. A balloon covering according to claim 16, wherein when the corresponding mating surfaces of the first shell member and the second shell member are engaged with each other, the first mating element of the first shell member is configured to mate with the second mating element of the second shell member, and the second mating element of the first shell member is configured to mate with the first mating element of the second shell member.

18. The balloon covering of any one of claims 1-17, further comprising a sleeve configured to be positioned around the first portion of the first shell member and the first portion of the second shell member such that the first shell member and the second shell member remain in mating engagement with each other.

19. An assembly comprising: a delivery device comprising a first shaft and a second shaft extending through the first shaft and having a distal portion extending distally beyond a distal portion of the first shaft; an expandable balloon coupled to the distal portion of the first shaft and covering a valve mounting portion of the delivery device, the valve mounting portion configured to receive a prosthetic valve in a radially compressed state; a positioning device coupled to the distal portion of the first shaft proximal to the valve mounting portion; as well as The balloon covering according to claim 1.

20. An assembly according to claim 19, wherein the width of the first shell portion of each of the first shell member and the second shell member is less than the width of the second shell portion of each of the first shell member and the second shell member, the width being defined in a direction perpendicular to the central longitudinal axis of the balloon covering, and wherein when the first shell member and the second shell member are cooperatively engaged with each other around the delivery device, the central longitudinal axis of the balloon covering is coaxial with the central longitudinal axis of the delivery device.

21. An assembly according to claim 19 or claim 20, wherein each of the first shell member and the second shell member includes a flat mating surface, and wherein the flat mating surface of the first shell member and the flat mating surface of the second shell member are configured to engage each other in a mating manner.

22. A component according to claim 21, wherein a portion of the flat mating surface included on the second shell portion of the first shell member includes a first mating element, and a portion of the flat mating surface included on the second shell portion of the second shell member includes a second mating element, and the first mating element and the second mating element are configured to mate with each other and prevent the first shell member and the second shell member from sliding relative to each other.

23. A component according to any one of claims 19-22, wherein the first shell portion of the first shell member and the first shell portion of the second shell member each include an outer surface, an inner surface and a recess, the recess being recessed into the inner surface toward the outer surface and extending along the length of the corresponding first shell portion, the length being defined in a direction parallel to the central longitudinal axis of the balloon covering, wherein the inner surface of the first shell portion of the first shell member and the inner surface of the first shell portion of the second shell member are configured to cooperatively engage with each other, and wherein the recess of the first shell member and the recess of the second shell member together form the first cavity.

24. A component according to claim 23, wherein each recess includes a distal portion and a proximal portion, wherein the distal portion is formed to receive the distal portion of the balloon covering the distal shoulder of the delivery device, and the proximal portion is formed to receive the middle portion of the balloon covering the valve mounting portion of the delivery device.

25. The assembly of claim 24, wherein the distal shoulder is coupled to the distal end portion of the second shaft and includes a flared portion disposed adjacent the valve mounting portion.

26. A component according to any one of claims 19-25, wherein the positioning device includes a flange portion, which is arranged at the distal end of the positioning device and extends radially outward from the body of the positioning device, and wherein the diameter of the second cavity is larger than the outer diameter of the flange portion of the positioning device.

27. A component according to claim 26, wherein the second shell portion of the first shell member includes one or more protruding wall portions, which protrude into the second cavity and form one or more cavities, and the one or more cavities are configured to receive and retain a portion of the flange portion of the positioning device therein so as to prevent the positioning device and the balloon cover from rotating relative to each other.

28. The assembly of any one of claims 19-27, further comprising a sleeve configured to be positioned around the first housing portion of the first housing member and the first housing portion of the second housing member such that the first housing member and the second housing member remain in mating engagement with each other.

29. The assembly of any one of claims 19-28, further comprising a radiopaque marker disposed on a distal portion of the delivery device.

30. The assembly of claim 29, wherein the radiopaque marker is disposed on a distal shoulder coupled to the distal portion of the second shaft, the distal shoulder being disposed adjacent the valve mounting portion.

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