Commissural markers for artificial heart valves

Abstract

There is a need for an improved prosthetic heart valve configuration that allows for the identification of the location of one or more commissures of the prosthetic heart valve during the transplantation procedure and / or after transplantation with a natural heart valve. [Solution] A method and system for attaching a radiopaque marker to an artificial heart valve to indicate the location of the commissure of the artificial heart valve is disclosed. The artificial heart valve may include a frame comprising a plurality of struts, the struts forming a plurality of cells of the frame disposed between the inlet and outlet ends of the frame; a plurality of valve leaflets disposed within the frame; at least one commissure comprising a mounting member disposed across a selected cell among the plurality of cells of the frame and attached to the struts of the frame forming the selected cell, and commissure tabs of two adjacent valve leaflets coupled to the mounting member; and a radiopaque marker disposed on the mounting member of the commissure. The marker is configured to indicate the location of the commissure of the artificial heart valve.

Description

Technical Field

[0001] Cross - reference to Related Applications This application claims the benefit of U.S. Provisional Patent Application No. 63 / 138,890, filed on January 19, 2021, and also claims the benefit of U.S. Provisional Patent Application No. 63 / 069,567, filed on August 24, 2020, which are hereby incorporated by reference in their entirety.

[0002] This disclosure relates to markers for artificial heart valves and configured to indicate the location of commissures of artificial heart valves.

Background Art

[0003] The human heart can suffer from various valve diseases. These valve diseases can lead to significant heart dysfunction and may ultimately require repair of the native valve or replacement of the native valve with an artificial valve. There are several known repair devices (e.g., stents) and artificial valves, as well as several known methods of implanting these devices and valves into humans. Percutaneous and minimally invasive surgical approaches are used in various procedures to deliver artificial medical devices to locations inside the body that are not easily accessible surgically or where access without surgery is desirable. In one specific example, an artificial heart valve can be mounted in a crimped state on the distal end of a delivery device and advanced through the patient's vasculature (e.g., through the femoral artery and aorta) until the artificial valve reaches the implantation site within the heart. The artificial valve can then be expanded to its functional size, for example, by inflating a balloon on which the artificial valve is mounted.

[0004] When an artificial valve is deployed in relation to a natural valve (e.g., by inflating the balloon of a delivery device), the radially expanded artificial valve is deployed with a random radial orientation relative to the natural valve. Therefore, in some embodiments, one of the commissures of the artificial valve may be positioned in front of (e.g., adjacent to) the coronary orifice of the aorta. This positioning may cause difficulties during future cardiovascular interventions aimed at reducing and / or maintaining or increasing coronary access (e.g., blood flow from the aorta to the coronary arteries). Furthermore, after implantation of the artificial heart valve, it may be desirable to confirm the location of the artificial heart valve commissure relative to the natural heart valve commissure.

[0005] Therefore, there is a need for an improved artificial heart valve configuration that allows for the identification of the location of one or more commissures of the artificial heart valve during and / or after implantation with a natural heart valve. [Overview of the project] [Means for solving the problem]

[0006] This specification describes embodiments of an artificial heart valve that include one or more radiopaque markers located on or near the commissure of the artificial heart valve. As a result, the location of a selected commissure of the artificial valve can be identified by medical imaging during the valve implantation procedure and / or after the artificial heart valve has been implanted into the natural heart valve.

[0007] In one representative embodiment, the artificial heart valve comprises: a frame including a plurality of struts, the struts forming a plurality of cells of the frame disposed between the inlet and outlet ends of the frame; a plurality of valve leaflets disposed within the frame; at least one commissure including a mounting member disposed across a selected cell among the plurality of cells of the frame and attached to the struts of the frame forming the selected cell, and commissure tabs of two adjacent valve leaflets coupled to the mounting member; and a radiopaque marker disposed on the mounting member of the commissure, the marker configured to indicate the location of the commissure of the artificial heart valve.

[0008] In another representative embodiment, the artificial heart valve comprises a frame including a plurality of struts, the struts forming a plurality of cells of the frame disposed between the inlet and outlet ends of the frame; a plurality of valve leaflets disposed within the frame; a first mounting member disposed across a selected cell among the plurality of cells of the frame and attached to a strut of the frame forming the selected cell, and at least one commissure comprising commissure tabs of two adjacent valve leaflets coupled to the first mounting member; and a radiopaque marker attached to a second mounting member, the second mounting member disposed across a selected cell and attached to a strut forming the selected cell, and the second mounting member disposed outside the first mounting member with respect to the central longitudinal axis of the frame. The marker is configured to indicate the location of the commissure of the artificial heart valve.

[0009] In another representative embodiment, the artificial heart valve comprises a frame including a plurality of struts, the struts forming a plurality of cells of the frame disposed between the inlet and outlet ends of the frame; a plurality of valve leaflets disposed within the frame; and at least one commissure having commissure tabs of two adjacent valve leaflets among the plurality of valve leaflets connected to each other, the at least one commissure fixed to a strut of the frame forming a selected cell among the plurality of cells; and a radiopaque marker attached to a mounting member, the mounting member being disposed across the selected cell and attached to a strut forming the selected cell. The marker is configured to indicate the location of the commissure of the artificial heart valve.

[0010] The aforementioned and other purposes, features, and advantages of the disclosed technology will become more apparent from the following detailed description, which will proceed with reference to the attached drawings. [Brief explanation of the drawing]

[0011] [Figure 1] This is a perspective view of an artificial heart valve according to one embodiment. [Figure 2A]This is a perspective view of an artificial heart valve according to another embodiment. [Figure 2B] Figure 2A is a perspective view of an artificial valve, where components outside the frame are indicated by transparent lines for illustrative purposes. [Figure 3] This is a perspective view of a delivery device for an artificial heart valve according to an embodiment. [Figure 4] This is a schematic diagram of an exemplary heart showing the position of the coronary arteries relative to the aortic valve. [Figure 5A] An illustrative diagram shows the positioning of an artificial valve within the aortic valve relative to the coronary arteries. [Figure 5B] Another exemplary positioning of a prosthetic valve within the aortic valve relative to the coronary arteries is illustrated, where the prosthetic valve at least partially obstructs blood flow to the coronary arteries. [Figure 6A] This is a cross-sectional view of the aortic valve illustrating the first position of the prosthetic valve within the aortic valve, where the commissure of the prosthetic valve at least partially blocks one or more openings to the coronary arteries. [Figure 6B] This is a cross-sectional view of the aortic valve illustrating the second position of the prosthetic valve within the aortic valve, where the commissure of the prosthetic valve is circumferentially aligned with the natural commissure of the aortic valve, thereby maintaining access to the coronary arteries. [Figure 7] This illustrates a leafletectomy procedure in which the leaflets of the natural aortic valve may be divided at the entrance to the coronary arteries when an artificial heart valve is implanted within the aortic valve, allowing increased blood flow to enter the coronary arteries. [Figure 8A] An example is illustrated showing how a representative artificial heart valve and the separation of the natural valve leaflets surrounding the artificial heart valve in the region of the artificial heart valve frame between two adjacent commissures result in an open cell before the coronary artery inlet. [Figure 8B] Figure 8A illustrates how dividing the natural valve leaflets within the region of the artificial heart valve frame, including the commissure, does not result in an open cell positioned in front of the coronary artery inlet. [Figure 9] This is a side view of an embodiment of a delivery device configured to deliver and implant a radially expandable artificial heart valve at a transplant site. [Figure 10]It is a cross-sectional side view of the distal end portion of the delivery device of FIG. 9. [Figure 11] It is a side view of the distal tip portion of the delivery device of FIG. 9, showing the distal end portion of the outer shaft of the delivery device. [Figure 12] It is a schematic view of an embodiment of the intermediate shaft of the delivery device of FIG. 9. [Figure 13] It is a cross-sectional side view of the distal portion of the coaxial shaft of the delivery device of FIG. 11. [Figure 14] It is a cross-sectional side view of the handle of the delivery device of FIG. 9. [Figure 15] It is a first perspective view of an embodiment of a rotatable knob mounted on the proximal end portion of the intermediate shaft of the delivery device, configured to rotate the intermediate shaft and thereby rotate the expandable balloon and the prosthetic heart valve radially compressed thereon. [Figure 16] It is a second perspective view of the knob of FIG. 15. [Figure 17] It is a cross-sectional side view of the knob of FIG. 15. [Figure 18] It is a cross-sectional view of an anchor of the knob of FIG. 15, configured to couple the knob to the intermediate shaft. [Figure 19] It is a perspective view of the anchor of FIG. 18. <了 [Figure 20] It is an exploded view of the outer housing of the knob of FIG. 15. [Figure 21] It is a side view of the anchor of FIG. 18 mounted on the proximal end portion of the intermediate shaft. [Figure 22] It is a side view of the knob of FIG. 15 mounted on the proximal end portion of the intermediate shaft, with one housing portion of the outer housing removed to show the anchor. [Figure 23] It is a perspective view of an embodiment of the proximal end portion of the delivery device, including a handle, a rotatable knob, and an adapter. [Figure 24] It is a perspective view of the adapter of FIG. 23, comprising a first port and a second port configured to rotate with respect to the body of the adapter and the first port. [Figure 25]Figure 24 is a cross-sectional view of the adapter. [Figure 26] This is a cross-sectional view of the adapter shown in Figure 24, mounted on the proximal end portion of the delivery device. [Figure 27] Figure 26 is a detailed cross-sectional view of a portion of the adapter, including a rotating joint surface between the second port and the adapter body. [Figure 28] An exemplary radiopaque marker is positioned on and / or embedded within the polymer body of the distal end of the delivery device, and a side view of the distal end of the delivery device is shown. [Figure 29] Figure 28 illustrates an exemplary fluorescence fluoroscopy image of the distal portion of the delivery device, including the radiopaque marker. [Figure 30] An embodiment of an asymmetric radiopaque marker is illustrated, which allows the user to distinguish between two different positions of the marker within the imaging view. [Figure 31A] This is an exemplary fluorescence fluoroscopy image illustrating a guidewire extending through the distal end portion of the delivery device, and an asymmetric marker of Figure 30, which is positioned on or embedded in a portion of the distal end portion of the delivery device and oriented in a first orientation relative to the guidewire. [Figure 31B] This is an exemplary fluorescence fluoroscopy image illustrating a guidewire extending through the distal end portion of the delivery device, and an asymmetrical marker, Figure 30, positioned on or embedded in a portion of the distal end portion of the delivery device and oriented in a second orientation relative to the guidewire. [Figure 32A] Figure 30 is a side view of an exemplary delivery device in which the asymmetric marker is positioned on or embedded inside the distal shoulder of the delivery device. [Figure 32B] Figure 32A is a perspective view of an exemplary delivery device in which the asymmetric marker shown in Figure 30 is positioned on or embedded inside the distal shoulder of the delivery device. [Figure 33] Another embodiment of an asymmetric radiopaque marker is illustrated, which allows the user to distinguish between two different positions of the marker within the imaging view. [Figure 34A]This is an exemplary fluorescence fluoroscopy image illustrating a guidewire extending through the distal end portion of the delivery device, and an asymmetric marker, Figure 33, positioned on or embedded in a portion of the distal end portion of the delivery device, and oriented in a first orientation relative to the guidewire. [Figure 34B] This is an exemplary fluorescence fluoroscopy image illustrating a guidewire extending through the distal end portion of the delivery device, and an asymmetric marker, Figure 33, positioned on or embedded in a portion of the distal end portion of the delivery device, and oriented in a second orientation relative to the guidewire. [Figure 35A] An exemplary embodiment of a radiopaque marker attached to the commissure of an artificial valve having a radially compressed configuration is illustrated. [Figure 35B] Figure 35A illustrates the artificial valve in a radially extended configuration. [Figure 35C] An exemplary artificial heart valve is illustrated, having a first mounting member positioned across the cells of the artificial heart valve and fixed to the struts forming the cells, and a radiopaque marker fixed to a second mounting member configured to be attached to the struts forming the cells, wherein the commissure tabs of adjacent leaflets of the artificial heart valve are fixed to the first mounting member to form a commissure. [Figure 35D] The first and second mounting members, attached to the support column that simultaneously forms cells using the same suture thread, are shown in the diagram. [Figure 35E] The first and second mounting members, attached to the support column that simultaneously forms cells using the same suture thread, are shown in the diagram. [Figure 35F] The first and second mounting members, attached to the support column that simultaneously forms cells using the same suture thread, are shown in the diagram. [Figure 35G] Figure 35C illustrates the marker attached to the second mounting member, which is attached to the support that forms the cell of the artificial valve in front of the first mounting member of the commissure. [Figure 35H] The first mounting member attached to the inner surface of the commissure and the cell of the artificial valve is shown in the diagram. [Figure 35I]An exemplary radiopaque marker configured to be attached to the commissure within the cell of an artificial valve is illustrated. [Figure 35J] Another exemplary embodiment of a radiopaque marker attached to the commissure within the cell of an artificial valve is illustrated. [Figure 35K] Another exemplary embodiment of a radiopaque marker attached to the commissure within the cell of an artificial valve is illustrated. [Figure 35L] Another exemplary embodiment shows a radiopaque marker attached to the commissure within the cell of the artificial valve, and a radiopaque marker attached to a skirt extending across the inner surface of the artificial valve frame directly below the commissure. [Figure 35M] Another exemplary embodiment of a radiopaque marker attached to the commissure within the cell of an artificial valve having a radially compressed configuration is illustrated. [Figure 35N] Another exemplary embodiment of a radiopaque marker attached to the commissure within the cell of an artificial valve having a radially compressed configuration is illustrated. [Figure 35O] An exemplary embodiment of a radiopaque marker is shown, which is a first mounting member attached to a first mounting portion that is attached to a second mounting member of a commissure within the cell of an artificial valve. [Figure 35P] Another exemplary embodiment of a radiopaque marker is shown, which is a first mounting member attached to a first mounting portion that is attached to a second mounting member of a commissure within the cell of an artificial valve. [Figure 36] This shows an embodiment of a folded inflatable balloon around the distal end portion of a delivery device. [Figure 37] This is a cross-sectional view of an inflatable balloon that is wrapped around and folded around a part of the delivery device in the valve mounting portion of the delivery device according to an embodiment. [Figure 38] This is a perspective view of an embodiment of the distal tip portion of the external shaft of a delivery device, which includes multiple spiral internal expansion grooves. [Figure 39] This is a cross-sectional view of the distal tip portion of Figure 38, which is mounted on the distal end of the outer shaft and positioned across a portion of the inflatable balloon of the delivery device. [Figure 40] This is a side view of the distal end portion of a delivery device, illustrating the radial pressure area within the distal end portion of the inflatable balloon of the delivery device when the distal tip portion is positioned away from the proximal end portion of the balloon. [Figure 41] Figure 40 is a side view of the distal end of the delivery device, illustrating the state of the distal end of an inflatable balloon when the distal tip is positioned across the proximal end of the balloon and the artificial valve is mounted on the valve mounting portion of the delivery device. [Figure 42] This is a side view of the distal end of an exemplary delivery device, in which an artificial valve is mounted radially compressed on and around the valve mounting portion of the distal end of the delivery device, and a selected commissure of the artificial valve is circumferentially offset by a predetermined amount from a radiopaque marker on the delivery device. [Figure 43] This is a rear perspective view of an exemplary embodiment of a crimping device configured to crimp an artificial valve onto a portion of a delivery device. [Figure 44] Figure 43 is a front perspective view of the crimping machine. [Figure 45] This is a perspective view of an embodiment of a support body for a mounting assembly configured to mount and crimp an artificial valve onto a delivery device in a predetermined position and / or orientation relative to the delivery device, wherein the support body is configured to hold the artificial valve in a radially expanded state. [Figure 46] Figure 45 is a front perspective view of an embodiment of a ring body configured to be coupled to a support body and to circumferentially align the artificial valve on the support body in a desired orientation. [Figure 47] Figure 46 is a rear perspective view of the ring body. [Figure 48] Figure 46 is a perspective view of the ring body connected to the support body shown in Figure 45. [Figure 49] This is a perspective view of an embodiment of a positioning device for a mounted assembly coupled to the distal end portion of a delivery device. [Figure 50] This is an end view of an artificial valve mounted on the support body of Figure 45, with the commissure aligned with the corresponding indicator on the ring body of Figure 46. [Figure 51]This is a cross-sectional view of a mounting assembly, which includes a support body (Figure 45) and a positioning device (Figure 49), coupled to and disposed inside the crimping device (Figure 43) such that the artificial valve is positioned relative to the delivery device in a predetermined orientation and / or position around the valve mounting portion of the distal end of the delivery device. [Figure 52] This is a cross-sectional view of the artificial valve that has been radially compressed onto the valve mounting portion of the delivery device after performing a crimping operation using the crimping equipment shown in Figure 43. [Figure 53] This is a perspective view of another embodiment of a positioning device that can be used in a mounting assembly and coupled to a crimping device. [Figure 54] This is a side view of the positioning device shown in Figure 53, which is coupled to the distal end of the delivery device at the proximal end of the valve mounting section. [Figure 55] This is a perspective view of the positioning device shown in Figure 53, which is coupled to the distal end of the delivery device shown in Figure 54. [Figure 56] This is a flowchart illustrating an exemplary method for crimping an artificial valve onto the distal end portion of a delivery device in a radially compressed state, at a predetermined position and orientation relative to the delivery device. [Figure 57] This is a flowchart illustrating an exemplary method for implanting an artificial valve in a patient's natural valve, where one or more selected commissures of the artificial valve are aligned with one or more corresponding commissures of the natural valve. [Figure 58] Exemplary fluorescence fluoroscopic images of a natural lobe, observed using a standard three-lobe imaging view, are shown. [Figure 59] An exemplary fluoroscopic image of the distal end portion of a delivery device is shown, including an asymmetric radiopaque marker that is centrally positioned along a guidewire extending through the delivery device and appears in a forward-readable orientation, thereby indicating that the marker is directly behind the imaging view. [Figure 60] This schematic diagram illustrates the desired rotational positioning of the distal end portion of the delivery device in a natural valve, including the artificial valve mounted thereon, where the asymmetric radiopaque marker of the delivery device is aligned with the target commissure of the natural valve, and the selected commissure of the artificial valve is offset circumferentially from the marker by a predetermined amount. [Figure 61]This is a schematic diagram of an embodiment of a three-lobe imaging view of a natural valve, which may be used to visualize the delivery device within the patient's heart during an implantation procedure and to rotationally align the artificial valve mounted on the delivery device. [Figure 62] Figure 61 is a cross-sectional view of the natural valve illustrating the location of the commissure within the imaging view. [Figure 63] This is a schematic diagram of an embodiment of a right / left lobe overlapping imaging view of a natural valve, which can be used to visualize the delivery device within the patient's heart during an implantation procedure and to rotationally align the prosthetic valve mounted on the delivery device. [Figure 64] Figure 63 is a cross-sectional view of the natural valve illustrating the location of the commissure within the imaging view. [Figure 65] Using a first imaging view, an embodiment of a matching ring configured to rotate-match an artificial valve to a delivery device for an implantation procedure is illustrated. [Figure 66] Using a second imaging view, another embodiment of a matching ring configured to rotate-match an artificial valve to a delivery device for an implantation procedure is illustrated. [Figure 67] Another embodiment of the matching ring is illustrated, which includes multiple sets of matching markers for use in two or more implantation procedures, utilizing differently selected imaging views. [Figure 68] Another embodiment of the alignment ring, which includes one or more sets of graduated alignment markers, is illustrated. [Figure 69] This is an exploded view of an embodiment of a balloon cover for the distal end portion of a delivery device, configured to cover an inflatable balloon and a positioning device mounted on the distal end portion. [Figure 70] Figure 60 is a perspective view of a shell member of a balloon cover, which is configured to interlock with another shell member of the balloon cover to form the outer shell of the balloon cover. [Figure 71A] This is a detailed view of a portion of the interlocking edge of the shell member shown in Figure 70, including an elongated protrusion. [Figure 71B] This is a detailed view of another portion of the interlocking edge of the shell member in Figure 70, which includes an elongated groove. [Figure 71C] Figure 60 shows a detailed view of a portion of the interlocking joint surface between two shell members of the balloon cover, in an assembly configuration where the interlocking edges of the two shell members are engaged with each other. [Figure 72] Figure 69 is a first side view of the balloon cover, showing the assembled configuration, with components located inside the balloon cover and covered by the balloon cover, indicated by dashed lines. [Figure 73] Figure 69 is a second side view of the balloon cover in the assembly configuration, and this second side view is rotated from the first side view in Figure 72. [Figure 74] Figure 69 is a perspective end view of the balloon cover from the proximal end of the balloon cover in the assembled configuration. [Figure 75A] Figure 69 is a perspective view of the balloon cover in an assembled configuration, in which a portion of the balloon cover covering the positioning device has a wall containing one or more windows configured to reduce the height of the balloon cover. [Figure 75B] Figure 75A is an end view of the balloon cover. [Figure 75C] Figure 75A is a cross-sectional end view of the balloon cover. [Figure 76A] This is a perspective view of another embodiment of a balloon cover for the distal end portion of a delivery device, configured to cover an inflatable balloon and a positioning device mounted on the distal end portion, wherein a portion of the balloon cover covering the positioning device has a wall that completely encloses the positioning device therein. [Figure 76B] Figure 76A is an end view of the balloon cover. [Figure 77] This is an exploded view of another embodiment of a balloon cover for the distal end portion of a delivery device, which is configured to cover an inflatable balloon and a positioning device mounted on the distal end portion, and to create a specific final shape for the inflatable balloon. [Figure 78] Figure 77 is a perspective view of a pressing sleeve for a balloon cover, which includes one or more pressing members. [Figure 79]Figure 78 is an end view of the push sleeve. [Figure 80] Figure 78 is another perspective view of the push sleeve. [Figure 81A] This is a cross-sectional side view of the pressing sleeve in Figure 78 in a non-flexible or stationary configuration. [Figure 81B] This is a cross-sectional side view of the pressing sleeve in Figure 78 in a flexural or radially inward configuration. [Figure 82] Figure 77 is a perspective view of the shell component of the balloon cover, disassembled from the remaining parts of the balloon cover. [Figure 83A] Figure 77 is a first cross-sectional side view of the assembled balloon cover. [Figure 83B] Figure 77 is a second cross-sectional side view of the assembled balloon cover. [Figure 84] This is a plan view of another exemplary embodiment of a shell member for a balloon cover, which is configured to receive a portion of the distal end of a delivery device, including an inflatable balloon and a positioning device mounted thereon, and to form a specific final shape of the balloon around the delivery device. [Figure 85] Figure 84 is a perspective view of the shell member. [Figure 86] Figure 84 is a cross-sectional side view of the shell member. [Figure 87A] This is a perspective view of a shaft connector release assembly that connects the proximal end portion of the rotatable shaft of a delivery device to an adapter. [Figure 87B] Figure 87A is a cross-sectional view of the shaft connector release assembly, which connects the proximal end portion of a rotatable shaft to an adapter. [Figure 88] Figure 87A is an exploded view of the shaft connector release assembly, the proximal end portion of the rotatable shaft, and the adapter. [Figure 89] Figure 87A is a perspective view of the shaft connector release assembly alone in the assembly configuration. [Figure 90] Figure 89 is an exploded view of the shaft release assembly. [Figure 91]Figure 89 is a perspective view of an embodiment of the release sleeve of a shaft connector release assembly. [Figure 92] Figure 91 is a side view of the release sleeve. [Figure 93] Figure 92 is a cross-sectional side view of the release sleeve. [Figure 94] Figure 89 is a perspective view of an embodiment of the adapter insert for the shaft connector release assembly. [Figure 95] Figure 94 is a side view of the adapter insert. [Figure 96] Figure 95 is a cross-sectional side view of the adapter insert. [Figure 97] An exemplary radiopaque marker is shown, sewn to the central portion of a mounting member configured to form a commissure with the commissure tabs of adjacent valve leaflets of an artificial heart valve, positioned across the cell of the artificial heart valve, and fixed to the struts forming the cell. [Figure 98A] Figure 97 shows a marker fixed to the outer surface of the mounting member and a connecting tab fixed to the inner surface of the mounting member. [Figure 98B] Figure 98A shows the mounting member attached to the cell support and the marker pointing outward from the cross joint. [Figure 99A] Figure 97 shows a marker fixed to the outer surface of the mounting member and a connecting tab fixed to the inner surface of the mounting member. [Figure 99B] Figure 99B shows the mounting member attached to the cell support and the marker pointing outward from the cross joint. [Figure 100] An exemplary embodiment of a marker positioned on an elongated flap of a mounting member, which is configured to form a commissure with the commissure tabs of adjacent valve leaflets of an artificial heart valve, is arranged across the cell of the artificial heart valve, and is fixed to a support that forms the cell. [Figure 101A] The process for sewing the marker to the mounting member in Figure 100 is shown using one or more fasteners used to secure the valve leaflet commissure tab to the mounting member. [Figure 101B]The process for sewing the marker to the mounting member in Figure 100 is shown using one or more fasteners used to secure the valve leaflet commissure tab to the mounting member. [Figure 101C] The process for sewing the marker to the mounting member in Figure 100 is shown using one or more fasteners used to secure the valve leaflet commissure tab to the mounting member. [Figure 101D] The process for sewing the marker to the mounting member in Figure 100 is shown using one or more fasteners used to secure the valve leaflet commissure tab to the mounting member. [Figure 101E] The process for sewing the marker to the mounting member in Figure 100 is shown using one or more fasteners used to secure the valve leaflet commissure tab to the mounting member. [Figure 102] This is a perspective view of another embodiment of a rotatable knob mounted on the proximal end portion of an intermediate shaft of a delivery device, configured to rotate the intermediate shaft, thereby rotating an inflatable balloon and an artificial heart valve radially compressed on the balloon. [Figure 103] Figure 102 is a side view of the knob. [Figure 104] Figure 102 is a first exploded view of the knob, showing the two housing parts of the knob that enclose the anchor and adapter. [Figure 105] This is a second exploded view of the knob in Figure 102. [Figure 106] Figure 102 is a first cross-sectional side view of the knob, showing the anchor and adapter inside the knob housing. [Figure 107] Figure 102 is a second cross-sectional side view of the knob, showing the alignment tabs for the anchor and adapter inside the knob housing. [Figure 108] This is a perspective view of another embodiment of a balloon cover for the distal end portion of a delivery device, configured to cover an inflatable balloon and a positioning device mounted on the distal end portion. [Figure 109] Figure 108 is a side view of the balloon cover. [Figure 110] Figure 108 is an exploded view of the balloon cover. [Figure 111] Another side view of the balloon cover in Figure 108 shows a sleeve covering a portion of the balloon cover, including a viewing window for a radiopaque marker located in the lower layer above the distal end portion of the delivery device. [Figure 112] Another side view of the balloon cover in Figure 111, with the sleeve removed so that the viewing window and the radiopaque marker located in the lower layer above the distal end portion of the delivery device are visible. [Figure 113] Figure 108 is a cross-sectional perspective view of the balloon cover. [Figure 114] Figure 108 is a partial cross-sectional side view of the balloon cover. [Modes for carrying out the invention]

[0012] General Considerations For the purposes of this description, specific aspects, advantages, and novel features of embodiments of the present disclosure are described herein. The methods, systems, and apparatus described herein should not be construed as limiting in any way. Rather, this disclosure covers all novel, non-expressive features and aspects of various disclosed embodiments, both individually and in various combinations and secondary combinations. The disclosed methods, systems, and apparatus are not limited to any specific aspect, feature, or combination thereof, and the disclosed methods, systems, and apparatus do not require that any one or more specific advantages exist or problems are solved.

[0013] Features, integers, properties, compounds, chemical parts, or bases described in conjunction with any particular aspect, embodiment, or example of this disclosure are understood to be applicable to any other aspect, embodiment, or example described herein, insofar as they are not incompatible with such other aspects, embodiments, or examples. All features disclosed herein (including the appended claims, abstract, and drawings) and / or all steps of any method or process disclosed herein may be combined in any combination, except for any combination in which at least some of such features and / or steps are mutually exclusive. This disclosure is not limited to the details of any of the aforementioned embodiments. This disclosure extends to any novel features or any novel combination of features disclosed herein (including the appended claims, abstract, and drawings), and to any novel steps or any novel combination of any method or process disclosed herein.

[0014] Some of the operations of the disclosed methods are described in a particular order for convenience, but please understand that this format of description includes rearrangement unless a specific order is required by the specific terminology described below. For example, operations described sequentially may, in some cases, be rearranged or performed simultaneously. Furthermore, for simplification, accompanying diagrams may not show the various ways in which the disclosed methods, systems, and apparatus may be used in conjunction with other systems, methods, and apparatus.

[0015] As used herein, the terms “a,” “an,” and “at least one” encompass one or more of the elements in question. That is, if two of the elements in question exist, then one of those elements also exists, and therefore an element (“an” element) exists. The terms “multiple” and “plural” mean two or more of the elements in question.

[0016] As used herein, the term "and / or" used between the last two elements in a list of elements means one or more of the enumerated 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."

[0017] As used herein, the term “combined” generally means physically joined or linked together, and unless a specific opposite term is provided, does not exclude the existence of intermediate elements between combined items.

[0018] Directions and other relative references (e.g., inside, outside, top, bottom, etc.) may be used to facilitate the discussion of the drawings and principles herein, but are not intended to be restrictive. For example, certain terms such as “inside,” “outside,” “top,” “bottom,” “internal,” “external,” and their equivalents may be used. Such terms are used, where applicable, to provide some clarity of explanation when dealing with relative relationships, particularly with respect to the illustrated embodiments. However, such terms are not intended to imply absolute relationships, positions, and / or orientations. For example, with respect to an object, an “upper” part can become a “lower” part simply by inverting the object. Yet, this is still the same part, and the object remains the same. Where used herein, “and / or” means “and” or “or,” as well as “and” and “or.”

[0019] As used herein, when referring to artificial heart valves and delivery devices, “proximal” refers to the location, orientation, or portion of a component closer to the handle of the delivery device, which is outside the user and / or patient, while “distal” refers to the location, orientation, or portion of a component further away from the handle of the delivery device and closer to the implantation site. The terms “longitudinal” and “axial” refer to axes extending in the proximal and distal directions, respectively, unless otherwise explicitly defined. Furthermore, the term “radial” refers to a direction perpendicular to an axis, oriented radially from the center of an object (where an axis, such as the longitudinal axis of an artificial valve, is centrally located).

[0020] Examples of the disclosed technology This specification describes embodiments of a valve delivery device and method for delivering a radially expandable valve and implanting it into a natural valve of the heart, such that the commissures of the artificial valve are circumferentially aligned within the commissures of the natural valve.

[0021] Furthermore, embodiments of balloon covers configured to receive the distal end portion of a delivery device are also described herein. In some embodiments, such balloon covers may be configured to create a specific shape of an inflatable balloon that covers a portion of the distal end portion of a delivery device.

[0022] Furthermore, this specification also describes an assembly for connecting a rotatable shaft of a delivery device to an adapter of the delivery device, which is configured to receive an inflation fluid for the delivery device's inflatable balloon.

[0023] In some embodiments, the delivery device may include a first shaft configured to rotate around a central longitudinal axis of the delivery device to rotationally align an artificial valve mounted on the delivery device with the natural anatomical structure at the target implantation site. The delivery device may further include a second shaft extending through the first shaft and having a distal end portion extending distally beyond the distal end portion of the first shaft. In some embodiments, one or more polymer bodies, such as balloon shoulders and / or nose cones, may be mounted on the distal end portion of the second shaft. The delivery device may further include an inflatable balloon coupled to the distal end portion of the first shaft. In some embodiments, the shoulders or other polymer bodies of the delivery device may be disposed within the balloon, and a radiopaque marker may be mounted on or embedded within the shoulder at a location radially outwardly separated from the outer surface of the distal end portion of the second shaft. The marker may be reflectively asymmetric along an axis parallel to the central longitudinal axis of the delivery device. The shoulder portion may be configured to resist axial movement relative to the balloon when the artificial valve is mounted on the balloon in a radially compressed state.

[0024] In this way, the delivery device may be configured to rotate and align the radially compressed prosthetic valve in the natural valve so that the prosthetic valve is implanted with its commissure aligned with (e.g., circumferentially aligned) the commissure of the natural valve. For example, rotating the first shaft may result in rotation of the balloon and the radially compressed prosthetic valve mounted thereon. In some embodiments, the first shaft may be rotated in or near the natural valve until a marker on the shoulder of the delivery device or on the alternative polymer body aligns with a desired landmark on the natural anatomical structure and / or guidewire in a selected imaging view.

[0025] The prosthetic valves disclosed herein may be radially compressible and expandable between a radially compressed configuration and a radially expanded configuration. Thus, the prosthetic valve may be compressed onto a delivery device in a radially compressed configuration during delivery, and then expand to a radially expanded configuration when the prosthetic valve reaches the implantation site. In some embodiments, the prosthetic valve may be deployed from the delivery device at the implantation site (e.g., a natural valve of the heart) by inflating an inflatable balloon of the delivery device.

[0026] Figure 1 shows an artificial heart valve (e.g., an artificial valve) 10 according to one embodiment. The illustrated artificial valve is adapted to be implanted in a natural aortic annulus, but in other embodiments it may be adapted to be implanted in other natural annulus of the heart (e.g., the pulmonary valve, mitral valve, and tricuspid valve). The artificial valve may also be adapted to be implanted in other tubular organs or passages in the body. The artificial valve 10 may have four main components: a stent or frame 12, a valve structure 14, an inner skirt 16, and a perivalve outer sealing member or outer skirt 18. The artificial valve 10 may have an inlet portion 15, an intermediate portion 17, and an outlet portion 19.

[0027] The valve structure 14 may comprise three leaflets 40 that collectively form a leaflet structure, which can be arranged to collapse in a tricuspid valve configuration, although in other embodiments, there may be more or fewer leaflets (e.g., one or more leaflets 40). The leaflets 40 can be fixed to each other at their adjacent sides to form a commissure 22 of the valve (e.g., leaflet) structure 14. The lower edge of the valve structure 14 may have a undulating, curved wavy shape and may be fixed to the inner skirt 16 by sutures (not shown). In some embodiments, the leaflets 40 may be formed from pericardial tissue (e.g., bovine pericardial tissue), biocompatible synthetic materials, or various other suitable natural or synthetic materials known in the Art and incorporated herein by reference, as described in U.S. Patent No. 6,730,118.

[0028] The frame 12 may be formed with a plurality of circumferentially spaced slots or commissure windows 20 adapted to mount the commissures 22 of the valve structure 14 onto the frame. The frame 12 may be made from any of the following suitable plastically expandable materials known in the art (e.g., stainless steel) or self-expanding materials (e.g., nickel-titanium alloy (NiTi) such as Nitinol). When constructed from a plastically expandable material, the frame 12 (and thus the prosthetic valve 10) is crimped into a radially collapsed configuration on the delivery catheter and can then be expanded inside the patient by an inflatable balloon or equivalent expansion mechanism. When constructed from a self-expanding material, the frame 12 (and thus the prosthetic valve 10) is crimped into a radially collapsed configuration and can be constrained in the collapsed configuration by insertion into the delivery catheter sheath or equivalent mechanism. 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.

[0029] Suitable plastically expandable materials that may 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 certain embodiments, the frame 12 is made from a nickel-cobalt-chromium-molybdenum alloy such as MP35N® alloy (SPS Technologies, Jenkintown, Pennsylvania), which is equivalent to UNS R30035 alloy (coated with ASTM F562-02). MP35N® alloy / UNS R30035 alloy contains 35% nickel, 35% cobalt, 20% chromium, and 10% molybdenum by weight. Additional details relating to the artificial valve 10 and its various components are described in WIPO Patent Application Publication No. 2018 / 222799, which is incorporated herein by reference.

[0030] Figure 2A is a perspective view of an artificial heart valve 50 according to another embodiment. The artificial 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 the artificial valve 50, with components outside the frame 52 (including the sealing member 56) indicated by transparent lines for illustrative purposes.

[0031] Similar to the valve structure 14 in Figure 1, the valve structure 54 may comprise three valve leaflets 60 that collectively form a valve leaflet structure, which may be arranged to collapse in a tricuspid configuration. Each valve leaflet 60 may be coupled to the frame 52 along its inlet edge 62 (also referred to as the lower edge in the figure, or "leaf edge") and in a joint 64 of the valve structure 54 where adjacent portions of two valve leaflets (e.g., joint tabs) are connected to each other. In some embodiments, the joint 64 may comprise a cell of the frame 52 (e.g., a joint cell) and a mounting member (e.g., fabric, flexible polymer, or equivalent) disposed across the cell formed by the frame's struts. The mounting member may be fixed to the frame's struts forming the cell, and adjacent portions of two valve leaflets may be coupled to the mounting member (e.g., as shown in Figures 16 and 17, as further described below) to form a joint 64.

[0032] Reinforcement elements such as fabric strips (not shown) can be connected directly to the edges of the valve leaflets and to the support struts of the frame, thereby joining the edges of the valve leaflets to the frame.

[0033] Similar to frame 12 in Figure 1, frame 52 can be made from any of a variety of suitable plastically expandable or self-expanding materials, as known in the art and as described above. In the illustrated embodiment, frame 52 comprises a plurality of circumferentially extending rows of angled supports 72 defining rows of cells or openings 74 of the frame. Frame 52 may 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 frame may have a diameter that changes along the height of the frame, as disclosed in U.S. Patent Publication 2012 / 0239142, incorporated herein by reference.

[0034] The frame 52 may have a plurality of vertices 80 spaced apart from each other around the circumference of the frame 52 at each of the inlet end 66 and the outlet end 68.

[0035] In the illustrated embodiment, the sealing member 56 is mounted on the outside of the frame 52 and functions to create a seal against surrounding tissue (e.g., natural valve leaflets and / or natural valve ring) to prevent or at least minimize perivalve leakage. The sealing member 56 may comprise 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 preferred technique or mechanism. For example, the sealing member 56 may be sutured to the frame 52 via sutures that extend around the support 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.

[0036] The outer layer 78 may be configured or molded to extend radially outward from the inner layer 76 and 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 to come into contact with the surrounding tissue.

[0037] Further details relating to the artificial valve 50 and its various components are described in U.S. Patent Publication No. 2018 / 0028310, which is incorporated herein by reference.

[0038] Figure 3 shows an embodiment of a delivery device (e.g., apparatus) 100 that may be used to implant an expandable artificial heart valve (e.g., artificial valve 10 or 50) or another type of expandable artificial medical device (e.g., a stent). In some embodiments, the delivery device 100 is specifically adapted for use when introducing an artificial valve into the heart.

[0039] The delivery device 100 in the embodiment illustrated in Figure 3 is a balloon catheter comprising a handle 102, a movable outer shaft 104 extending from the handle 102, an intermediate shaft extending coaxially from the handle 102 through the movable outer shaft 104, an inner shaft 106 extending coaxially from the handle 102 through the intermediate shaft and the movable outer shaft 104, an inflatable balloon (e.g., balloon) 108 extending from the distal end of the intermediate shaft, and a nose cone 110 disposed at the distal end of the delivery device 100. The distal end portion 112 of the delivery device 100 includes the balloon 108, the nose cone 110, and the balloon shoulder assembly. An artificial medical device, such as an artificial heart valve, may be mounted on the valve-retaining portion of the balloon 108, as further described below with reference to Figures 9-11, 41, and 42. As further described below, the balloon shoulder assembly is configured to maintain an artificial heart valve or other medical device in a fixed position on the balloon 108 during delivery through the patient's vascular system. In some embodiments, the balloon shoulder assembly may include a proximal shoulder 120 and / or a distal shoulder 122.

[0040] The handle 102 may include a steering mechanism configured to adjust the curvature of the distal end portion of the delivery device. In the illustrated embodiment, for example, the handle 102 includes an adjustment member such as a rotatable knob 134, which is operably coupled to the proximal end portion of a pull wire (not shown). The pull wire extends distally from the handle 102 through an outer shaft 104 and has a distal end portion attached to the outer shaft at or near the distal end of the outer shaft 104. Rotating the knob 134 is effective in increasing or decreasing the tension of the pull wire, thereby adjusting the curvature of the distal end portion of the delivery device.

[0041] In some embodiments, the delivery device (or another similar delivery device) may be configured to deploy and implant an artificial heart valve (e.g., artificial valve 10 in Figure 1 or artificial heart valve 50 in Figures 2A and 2B) within the natural annulus of the natural aortic valve. An exemplary heart 200 including the aortic valve 202 is shown in Figure 4. As shown in Figure 4, two coronary arteries (e.g., the left and right coronary arteries) 204 connect to and branch off from the aorta 205 adjacent to the aortic valve 202. The coronary arteries 204 carry oxygenated blood from the aorta to the heart muscle 200.

[0042] As shown in Figure 5A, since the artificial heart valve 206 is implanted in the natural aortic annulus of the aortic valve 202, blood flow 208 can exit the artificial heart valve 206, flow into the aorta 205, and then flow across the upper part of the outflow end of the artificial heart valve 206 and / or through open cells within the frame of the artificial heart valve 206 (e.g., open cells not always covered by the leaflets of the artificial heart valve) to the coronary arteries 204 (only one is shown in Figures 5A and 5B). Depending on the patient's anatomical structure, the artificial heart valve may cover at least a portion of the opening to the coronary arteries 204 (e.g., it may be positioned in front of it), as shown in the embodiment depicted in Figure 5B. Interference with blood flow to the coronary arteries 204 may be further exacerbated when the commissure 210 of the artificial heart valve 206 is positioned in front of (e.g., adjacent to) the opening to one of the coronary arteries 204 (Figure 5B). For example, because adjacent valve leaflets are joined together at the commissure 210, the commissure 210 blocks and / or reduces blood flow through the cells to which they are joined. Therefore, less oxygenated blood flow can reach the coronary arteries and myocardium.

[0043] Therefore, instead of deploying the artificial heart valve using a delivery device with a random rotational orientation relative to the aorta 205, and positioning the commissure 210 of the artificial heart valve 206 in front of the coronary artery 204 (as shown in Figure 6A), it may be preferable to deploy the artificial heart valve 206 with a targeted rotational orientation, such that the commissure 210 is positioned away from the coronary artery 204 and does not obstruct it (as shown in Figure 6B). For example, as shown in Figure 6B, the delivery device may be configured to deploy the artificial heart valve 206 such that the radially expanded commissure 210 of the artificial heart valve 206 is circumferentially aligned with the natural commissure 212 of the aortic valve 202.

[0044] As will be further described below, the delivery device may be configured to control the rotational positioning of the prosthetic valve 206 relative to the natural valve in order to achieve commissure alignment as shown in the embodiment of Figure 6B, thereby increasing blood flow access to the coronary artery 204. In addition, this positioning of the prosthetic valve can facilitate subsequent leaflet amputation procedures, which provide increased blood flow to the coronary arteries, as shown in Figures 7-8B.

[0045] For example, as shown in Figure 7, the natural valve leaflets 214 of a natural valve (e.g., aortic valve 202) can be longitudinally divided (e.g., cut) (with respect to the central longitudinal axis of the artificial heart valve 206) at the point of entry into the coronary artery 204. This allows increased blood flow to enter the coronary artery 204 from the aorta through one or more open (e.g., uncovered) cells 216 of the artificial heart valve 206.

[0046] As shown in Figure 8A, dividing the natural valve leaflet 214 (shown surrounding the artificial heart valve 206 as shown in Figures 8A and 8B) in the region of the artificial heart valve 206 frame between two adjacent commissures 210 results in an open cell 216 that can receive blood flow through it. However, as shown in Figure 8B, dividing the natural valve leaflet 214 within the region of the artificial heart valve 206 frame including the commissures 210 (for example, because the commissures 210 are positioned before the entrance to the coronary artery 204) does not allow the open cell 216 to be positioned before the entrance to the coronary artery 204. Instead, the commissures 210 can continue to block blood flow to the coronary artery 204.

[0047] Therefore, it is desirable to have a delivery device and method for deploying an artificial heart valve that can expand radially with a desired rotational orientation relative to the natural valve, so that the artificial heart valve commissure is aligned with the natural valve commissure.

[0048] Figures 9–68 show embodiments of a delivery device, method, and related components for implanting a radially expandable artificial heart valve into a natural valve using a delivery device, such that the commissures of the artificial heart valve are aligned with the commissures of the natural valve. In some embodiments, the artificial valve and delivery device are configured so that the artificial valve is deployed from the delivery device into the natural valve by inflating a balloon in the delivery device.

[0049] Figures 9–14 show a delivery device 300 according to an embodiment, which may be used to implant an expandable artificial heart valve (e.g., artificial valve 10 in Figure 1 or artificial valve 50 in Figures 2A–2B) or another type of expandable artificial medical device (e.g., a stent). In some embodiments, the delivery device 300 is specifically adapted for use when introducing an artificial valve into the heart. As further described below, the delivery device 300 may be configured to rotate the artificial valve, mounted on the delivery device in a radially compressed state, at the target implantation site (e.g., at the natural valve of the heart) to achieve commissure alignment between the natural valve and the artificial valve after the artificial valve has been deployed.

[0050] Similar to the delivery device 100 in Figure 3, the delivery device 300 is a balloon catheter comprising a handle 302 and a movable outer shaft 304 extending distally from the handle 302 (Figures 9 and 14). The delivery device 300 may further comprise an intermediate shaft 306 (which may also be called a balloon shaft) extending proximal to (Figures 9 and 14) and distal to the handle 302, the portion extending distally from the handle 302 also extending coaxially through the outer shaft 304. In addition, the delivery device 300 may further comprise an inner shaft 308 extending distally from the handle 302 coaxially through the intermediate shaft 306 and the outer shaft 304 (as shown in detail 355 of Figure 13) and proximal to the handle 302 coaxially through the intermediate shaft 306.

[0051] As further described below, the outer shaft 304 and the intermediate shaft 306 are configured to translate (e.g., move) longitudinally relative to each other along the central longitudinal axis 320 to facilitate the delivery and positioning of the artificial valve at the implantation site within the patient's body.

[0052] The intermediate shaft 306 may include a proximal end portion 310 that extends proximal from the proximal end of the handle 302 to the adapter 312 (Figures 9 and 14). A rotatable knob 314 may be mounted on the proximal end portion 310 (Figures 9 and 14) and may be configured to rotate the intermediate shaft 306 relative to the outer shaft 304 around the central longitudinal axis 320 of the delivery device 300, as further described below with reference to Figures 15-22.

[0053] The adapter 312 may include a first port 338 configured to receive a guidewire through it, and a second port 340 configured to receive fluid (e.g., expansion fluid) from a fluid source. The second port 340 may be fluidically coupled to the inner lumen of the intermediate shaft 306, as further described below.

[0054] The intermediate shaft 306 may further include a distal end portion 316 that extends distally beyond the distal end of 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 (as further described below with reference to, for example, Figures 38-41) (Figures 10 and 11). The distal end portion of the inner shaft 308 may extend distally beyond the distal portion 316 of the intermediate shaft 306 (Figure 10).

[0055] The balloon 318 is coupled to the distal end portion 316 of the intermediate shaft 306. For example, in some embodiments, the proximal end portion of the balloon 318 is coupled to and / or around the distal end 348 of the intermediate shaft 306 (Figures 10 and 11).

[0056] The balloon 318 may include a distal end portion (or section) 332, a proximal end portion (or section) 333, and an intermediate portion (or section) 335, the intermediate portion 335 being positioned between the distal end portion 332 and the proximal end portion 333.

[0057] In some embodiments, the distal end of the distal end portion 332 of the balloon 318 may be coupled to the distal end of the delivery device 300, such as the nose cone 322 (as shown in Figures 9-11) or an alternative component at the distal end of the delivery device 300 (e.g., the distal shoulder). In some embodiments, the intermediate portion 335 of the balloon 318 may overlap the valve mounting portion 324 of the distal end portion 309 of the delivery device 300, the distal end portion 332 may overlap the distal shoulder portion 326 of the delivery device 300, and the proximal end portion 333 may surround a portion of the inner shaft 308 (Figure 10). The valve mounting portion 324 and the intermediate portion 335 of the balloon 318 may be configured to receive an artificial heart valve in a radially compressed state (e.g., as shown in Figures 41 and 42, as further described below).

[0058] As further described below, the rotation of the intermediate shaft 306 results in the rotation of the balloon 318 and the artificial valve mounted thereon for rotational positioning of the artificial valve relative to the natural anatomical structure at the target implantation site.

[0059] The balloon shoulder assembly is configured to maintain the artificial heart valve or other medical device in a fixed position on the balloon 318 during delivery through the patient's vascular system. The balloon shoulder assembly may include a distal shoulder 326 (Figures 9-11) disposed within the distal end portion of the balloon 318 and coupled to the distal end portion of the inner shaft 308. The distal shoulder 326 may be configured to withstand the movement of the artificial valve or other medical device mounted on the valve mounting portion 324 distal to the balloon 318 in an axial direction (e.g., along the central longitudinal axis 320).

[0060] For example, in some embodiments, the distal shoulder portion 326 may include a wide-mouth portion 331 disposed adjacent to the valve mounting portion 324 (Figure 10). In some embodiments, the wide-mouth portion 331 may include a plurality of wings 330 that extend radially outward from the base (e.g., shaft) portion 325 of the distal shoulder portion 326 toward the valve mounting portion 324 (Figure 10), as will be discussed in more detail below with reference to Figures 28, 32A-32B, and 40-42.

[0061] The outer shaft 304 may include a distal tip portion 328 mounted on its distal end (Figures 9 and 11). In some embodiments, the distal tip portion 328 may be configured as a flexural adapter including a plurality of internal and external helical grooves, as further described below with reference to Figures 38-41. The outer shaft 304 and the intermediate shaft 306 may be axially translated relative to each other to position the distal tip portion 328 adjacent to the proximal end of the valve mounting portion 324 when the prosthetic valve is mounted radially compressed on the valve mounting portion 324 (for example, as shown in Figure 41) and during delivery of the prosthetic valve to the target implantation site. Thus, the distal tip portion 328 may be configured to resist the movement of the prosthetic valve relative to the balloon 318 axially and proximal when the distal tip portion 328 is positioned adjacent to the proximal side of the valve mounting portion 324.

[0062] In some embodiments, the nose cone 322 may be positioned distal to the distal shoulder portion 326 and coupled to the distal shoulder portion 326. In some embodiments, the nose cone 322 may be coupled to the distal end portion of the inner shaft 308.

[0063] In some embodiments, the delivery device 300 may include one or more markers or marker bands 353 configured to indicate to the user the location of a particular component of the delivery device. In some embodiments, one or more marker bands 353 may be radiopaque. In some embodiments, one or more marker bands 353 may be radially compressed (e.g., crimped) onto the inner shaft 308 (as shown in Figures 10 and 11, and also in Figures 32A and 40).

[0064] As shown in Figure 10, the distal end portion 332 of the balloon 318 may include a radial pressure portion 334 that is pressed inward toward the central longitudinal axis 320 relative to the outermost radial surface of the distal shoulder portion 326 and the outermost radial surface of the nose cone 322. The radial pressure portion 334 is described in more detail below with reference to Figures 40 and 41.

[0065] As shown in the detailed cross-sectional view of a selected portion 355 (from Figure 11) of the delivery device 300 in Figure 13, an annular space 336 may be defined between the outer surface of the inner shaft 308 and the inner surface of the intermediate shaft 306. In some embodiments, the annular space 336 may be referred to as the inner lumen of the intermediate shaft 306. In some embodiments, the annular space 336 may be configured to receive fluid from a fluid source via a second port 340 of the adapter 312 (for example, the annular space 336 is in fluid communication with the second port 340 of the adapter 312). The annular space 336 may be fluidically coupled to a fluid passage 342 formed between the outer surface of the distal end portion of the inner shaft 308 and the inner surface of the balloon 318 (Figure 10). Thus, fluid from the fluid source can flow from the annular space 336 to the fluid passage 342, inflating the balloon 318 and radially expanding and deploying the artificial valve.

[0066] The inner lumen 344 of the inner shaft 308 (Figure 13) may be configured to receive a guidewire through it in order to navigate the distal end portion 309 of the delivery device 300 to the target implantation site. As described above, the first port 338 of the adapter 312 may be coupled to the inner lumen 344 and configured to receive a guidewire. For example, the distal end portion 309 of the delivery device 300 can be advanced to the target implantation site over the guidewire. Exemplary guidewires are shown in Figures 29, 31A–31B, 34A–34B, and 59, as further described below.

[0067] As shown in the schematic diagram of the intermediate shaft 306 in Figure 12 and the detailed cross-sectional view of a selected portion 355 of the delivery device 300 (Figure 11) in Figure 13, in some embodiments, the intermediate (e.g., balloon) shaft 306 may include two layers of braided (or coiled) material configured to increase the torque resistance of the intermediate shaft 306 so that it can withstand rotation at the target implantation site. The braided or coiled material may include a metal or a more rigid braided or coiled material such as polyethylene terephthalate (PET).

[0068] For example, the intermediate shaft 306 can be disassembled into a first section 346 having a first length 356 and a second section 354 having a second length 358, where the first length 356 is longer than the second length 358 (Figure 12). The first length 356 can be the majority of the overall 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 about 6 inches. Thus, the first section 346 can extend from the proximal end section 310 of the intermediate shaft 306 to a distance away from the distal end 348 of the intermediate shaft 306 (e.g., the second length 358).

[0069] The two layers of braided material of the intermediate shaft 306 may include a first braided layer 350 that extends along the entire length of the intermediate shaft 306 (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 first portion 346 for most of the entire length of the intermediate shaft 306 (Figure 13). However, the second braided layer 352 stops before the second portion 354 (Figures 12 and 13). This allows the distal second portion 354 of the intermediate shaft 306 to have increased flexibility at the distal end portion 316.

[0070] In alternative embodiments, the second braided layer 352 may extend along the entire length of the intermediate shaft 306. In some alternative embodiments, the intermediate shaft 306 may contain more than two layers of braided material, such as three.

[0071] As shown in Figures 9 and 14, the handle 302 may include a steering mechanism configured to adjust the curvature of the distal end 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 is operably coupled to the proximal end portion of the pull wire. The pull wire extends distally from the handle 302 through an outer shaft 304 and has a distal end portion attached to the outer shaft 304 at or near the distal end of the outer shaft 304. Rotating the knob 360 increases or decreases the tension of the pull wire, thereby adjusting the curvature of the distal end portion 309 of the delivery device 300. Further details of steering or bending mechanisms for delivery devices can be found in U.S. Patent No. 9,339,384, which is incorporated herein by reference.

[0072] The handle 302 may further include an adjustment mechanism 361, which includes an adjustment member such as a rotatable knob 362 as shown in the figure, and a shaft 364 extending distally within the housing 366 of the handle 302. The adjustment mechanism 361 is configured to adjust the axial position of the intermediate shaft 306 relative to the outer shaft 304 (Figures 9 and 14). In some embodiments, as shown in Figure 14, an inner support member 368 is mounted within the 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 member 368. The inner shaft 370 has a distal end portion 372 formed with an external thread that engages with an internal thread that extends along the inner surface of the shaft 364. The inner shaft 370 further includes a proximal end portion 374 that interface-contacts with a locking mechanism 376 configured to hold (e.g., lock) the intermediate shaft 306 in position relative to the handle 302. The inner shaft 370 may be coupled to the inner support member 368 such that the rotation of the shaft 364 causes the inner shaft 370 to move axially within the handle 302. The locking mechanism 376 may include another adjustment member configured as a rotatable knob 378 that houses an inner nut 380 having an internal thread that engages with the external thread of the proximal end portion 374 of the inner shaft 370.

[0073] To restrain the movement of the intermediate shaft 306 for the fine positioning of the artificial valve mounted on the distal end portion of the delivery device 300, the knob 378 is rotated, which in turn causes the rotation of the inner nut 380. As a result, the inner nut 380 is translated distally along the external threads on the proximal end portion 374 of the inner shaft 370. As the nut 380 moves distally, additional components of the locking mechanism 376 frictionally engage with the intermediate shaft 306, thereby configuring it to hold 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 (either proximal or distal, depending on the direction in which the knob 362 is rotated).

[0074] Rotating the knob 378 in the opposite direction from the locked position to the unlocked position allows for axial and rotational movement of the intermediate shaft relative to the inner shaft 370 and the proximal end portion of the handle 302. Further details of 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.

[0075] As described above, the knob 314 of the handle 302 may be configured to rotate the intermediate (e.g., balloon) shaft 306, thereby rotating the balloon 318 mounted on the intermediate shaft 306 and the radially compressed artificial valve mounted on the balloon 318 around the valve mounting portion 324. Thus, rotating the knob 314 can rotate the artificial valve around the central longitudinal axis 320 to a desired orientation relative to the natural anatomical structure at the target implantation site.

[0076] Figures 15-22 show various embodiments of the knob 314 configured to rotate the intermediate shaft 306 when the knob 314 is rotated. In alternative embodiments, a differently configured rotatable knob or other adjustment mechanism may be used instead of the knob 314 to rotate the intermediate shaft 306 of the delivery device 300.

[0077] As shown in the perspective views of Figures 15 and 16 (and Figures 9 and 14 as described above), the knob 314 may be mounted on the proximal end portion 310 of the intermediate shaft 306 distal to the adapter 312. In some embodiments, the knob 314 may be directly coupled to and / or disposed around part or all of the adapter 312 (for example, as shown in Figures 102-107 further described below). In alternative embodiments, the knob 314 may be axially separated from the adapter 312.

[0078] The knob 314 may include an outer housing 382 disposed around (for example, housing) one or more internal components of the knob 314 (Figures 15-17 and 20). In some embodiments, the outer housing 382 may include one or more gripping elements 383 configured to increase the traction or gripping force for a user turning the knob 314. In some embodiments, one or more gripping elements 383 may be raised elements or features extending outward from the outer surface of the outer housing 382 and spaced apart from each other around the circumference of the outer housing 382. In alternative embodiments, one or more gripping elements 383 may be raised projections and / or recessed depressions within the outer housing 382.

[0079] In some embodiments, to increase the ease of assembly of the knob 314, the outer housing 382 may be divided into two or more interlocking components. For example, in some embodiments, as shown in Figures 15, 16, and 20, the outer housing 382 may comprise a first housing portion 384 and a second housing portion 385 configured to be removably coupled to one another. For example, each of the first housing portion 384 and the second housing portion 385 may include corresponding interlocking surfaces configured to couple the first housing portion 384 and the second housing portion 385 to one another. In this way, the first housing portion 384 and the second housing portion 385 are coupled to one another around the intermediate shaft 306 and the internal components of the knob 314, thereby forming the knob (e.g., knob assembly) 314.

[0080] The knob 314 may further include an anchor 386 disposed within the outer housing 382 and configured to anchor (e.g., connect) the knob 314 to the proximal end portion 310 of the intermediate shaft 306 (Figures 17-19). Figure 19 shows a cross-sectional view of the knob 314 with the anchor 386 connected to the intermediate shaft 306 and the outer housing 382 connected around the anchor 386. Figures 18 and 19 show a cross-sectional view and a perspective view of the anchor 386, respectively.

[0081] As shown in Figures 17-19, the anchor 386 may include a shaft portion 387 that defines an inner lumen 388 configured to receive and connect with the intermediate shaft 306. In some embodiments, the inner lumen 388 has a relatively constant inner diameter.

[0082] In some embodiments, the distal end of the shaft portion 387 may include one or more radially extending portions 389 extending around at least a portion of the circumference of the shaft portion 387 (Figures 17-19). In some embodiments, one or more or each of the radially extending portions 389 may extend around the entire circumference of the shaft portion 387. In some embodiments, one or more radially extending portions 389 may be configured as annular hooks spaced axially apart from one another.

[0083] One or more radially extending portions 389 may be configured to mesh with the interior of a sleeve element (which may also be called a strain-relieving element) 391 (Figure 17). In some embodiments, the sleeve element 391 may be disposed around a portion of the proximal end portion 310 of the intermediate shaft 306, and the outer housing 382 may include a wider first opening 392 configured to receive the proximal end of the sleeve element 391 into and / or to clamp it around (Figures 15-17). The sleeve element 391 may be configured to relieve strain between the knob and the proximal end portion of the second shaft. In some embodiments, the sleeve element 391 may include a flexible and / or elastic material such as an elastic polymer material (e.g., rubber).

[0084] The outer housing 382 may further include a narrower second opening (e.g., a channel) 393 configured to receive the distal portion of the adapter 312 (Figures 17 and 20).

[0085] As shown in Figures 17-19, the anchor 386 may comprise one or more extending portions (e.g., shafts or pins) 394 configured to engage with (e.g., extend into and / or connect with) a corresponding channel or opening 395 disposed within the outer housing 382 (Figures 17 and 20). The extending portions 394 may be spaced apart from each other and extend radially outward from the shaft portion 387 of the anchor 386.

[0086] In some embodiments, as shown in Figures 17-19, the anchor 386 may have two extending portions 394 extending from each of the two opposite sides of the anchor 386. However, in alternative embodiments, the anchor 386 may have more than four or fewer than four extending portions 394. The number of openings 395 may be the same as the number of extending portions 394.

[0087] In some embodiments, the interlocking portion of the opening 395 and the corresponding extension 394 may have a hexagonal shape. However, in alternative embodiments, other shapes such as rectangles, squares, or equivalents are possible.

[0088] In some embodiments, the anchor 386 may be configured to bond (e.g., UV bond) to the outer surface of the intermediate shaft 306. For example, in some embodiments, the shaft portion 387 of the anchor 386 may include one or more centralizing ribs 396 that are spaced apart around the circumference of the inner lumen 388 and extend along the inner lumen 388 (Figures 18 and 19). In some embodiments, the shaft portion 387 may include a viewing opening 397 (e.g., configured as a window) that may allow a user to visually inspect the alignment and / or bonding between the anchor 386 and the intermediate shaft 306 (Figures 18 and 19). For example, as shown in Figure 17, the opening 397 may extend between the outer and inner surfaces of the shaft portion 387 and be located within the central portion of the shaft portion 387. In some embodiments, the proximal end portion of the shaft portion 387 of the anchor 386 may include a counterbore 398 (Figures 17 and 18). The counterbore 398 can enable reinforced UV bonding between the anchor 386 and the intermediate shaft 306.

[0089] The knob 314 may also include a matching tab or extension 399 (Figures 21-22) configured to align the adapter 312 with a radiopaque marker (e.g., marker 500 shown in Figure 28, marker 600 shown in Figures 32A-32B, or marker 650 shown in Figure 33) disposed on the distal end portion 309 of the delivery device 300. In some embodiments, the matching tab 399 may extend radially outward from the anchor 386, as shown in Figures 21 and 22. In some embodiments, the matching tab 399 may extend radially outward from the shaft portion 387 of the anchor 386 in a direction perpendicular to the direction in which the extension 394 extends radially outward from the shaft portion 387 of the anchor 386. As further described below, during assembly, the alignment tab 399 may be aligned with the second port 340 of the adapter 312 such that they extend outward with respect to the central longitudinal axis 320 in relatively the same direction (for example, both outward from the same side of the intermediate shaft 306, as shown in Figures 21 and 22).

[0090] In some embodiments, the knob 314 may be assembled to the proximal end portion 310 of the intermediate (e.g., balloon) shaft 306 in the following manner. However, it should be noted that the assembly methods described below are illustrative and alternative assembly methods may be possible.

[0091] In some embodiments, during assembly, the sleeve element 391 may be mounted on and / or around the proximal end portion 310 of the intermediate shaft 306. The anchor 386 may then be positioned adjacent to the sleeve element 391 on and around the intermediate shaft 306. In some embodiments, when the intermediate shaft 306 is stationary on a relatively planar surface (e.g., a table), the delivery device 300 may be positioned such that the radiopaque marker on the distal end portion 309 faces upward (e.g., away from the table, appearing on the plane of the page in Figure 21), and the anchor 386 may be positioned such that the matching tab 399 faces away from the user (e.g., the individual assembling the device), as shown in Figure 21. For example, in Figure 21, the plane of the table may be within the plane of the page. After this part of the alignment is complete, the anchor 386 can be joined to the intermediate shaft 306 (for example, via UV bonding), and then the sleeve element 391 can be positioned across the radially extending portion 389 of the anchor 386.

[0092] In some embodiments, the assembly method may further include joining the adapter 312 to the intermediate shaft 306 such that the second port 340 is oriented in the same direction as the alignment tab 399 and / or the second port 340 and the alignment tab 399 are circumferentially aligned with respect to the circumference of the intermediate shaft 306 (Figures 21 and 22). In this way, during the implantation procedure, the user can determine the initial (e.g., initiation) position of the radiopaque marker on the distal end portion 309 of the delivery device 300 in 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.

[0093] Next, the outer housing 382 can 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 connecting them to each other.

[0094] Figures 102–107 show various diagrams of another embodiment of the knob (or handle) 2500, which is configured to rotate the intermediate shaft 306 of the delivery device 300 when the knob 2500 is rotated. The knob 2500 (also referred to as the handle or valve rotation control (VRC)) may function similarly 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 the adapter 312, or similar). Thus, in one specific embodiment, the delivery device 300 of Figure 9 includes the knob 2500 instead of the knob 314.

[0095] As shown in the perspective and side views of Figures 102 and 103, respectively, the knob 2500 is mounted on the proximal end portion 310 of the intermediate shaft 306 and may surround or contain the adapter 312 (or another similar adapter). For example, as shown in Figures 102-107, the knob 2500 is positioned around the adapter 312, enclosing the adapter 312, so that the user cannot grasp or rotate the adapter 312 independently of the knob 2500.

[0096] In some embodiments, the outer housing 2502 may include one or more gripping elements 2504 configured to increase the traction or gripping force for the user turning the knob 2500. In some embodiments, as shown in Figures 102-107, one or more gripping elements 2504 may be raised elements or features extending outward from the outer surface of the outer housing 2502 and spaced apart from each other around the circumference of the outer housing 2502. In alternative embodiments, one or more gripping elements 2504 may be raised projections and / or recessed depressions within the outer housing 2502.

[0097] In some embodiments, to increase the ease of assembly of the knob 2500, the outer housing 2502 may be divided into two or more interlocking components. For example, in some embodiments, as shown in the exploded views of Figures 103 and 104 and 105, the outer housing 2502 may comprise a first housing portion 2506 and a second housing portion 2508 configured to be removably coupled to one another. For example, each of the first housing portion 2506 and the second housing portion 2508 may include corresponding interlocking surfaces configured to couple the first housing portion 2506 and the second housing portion 2508 to one another. In this way, the first housing portion 2506 and the second housing portion 2508 are coupled to one another around the intermediate shaft 306 and the internal components of the knob 2500, thereby forming the knob (e.g., knob assembly) 2500.

[0098] Similar to the knob 314 in Figures 15-22, the knob 2500 may include an anchor 386 disposed within the outer housing 2502 (as shown in the cross-sectional side views of Figures 106 and 107) and configured to anchor (e.g., couple) the knob 2500 to the proximal end portion 310 of the intermediate shaft 306. For example, the anchor 386 may be coupled around the intermediate shaft 306 and configured to be in interfacial contact with the sleeve element 391, as described above with reference to Figures 15-22 (and as shown in Figures 106 and 107).

[0099] As described above with reference to Figures 15-22, the outer housing 1502 is configured to surround and connect to the anchor 386, to receive the proximal end of the sleeve element 391, and / or to fasten it around. For example, similar to the outer housing 382 of the knob 314, the outer housing 2502 may have a first opening 2510 (formed by the two halves when the two halves of the outer housing 2502 are joined together) configured to receive the proximal end of the sleeve element 391 into it and / or to fasten it around it (Figures 104-107).

[0100] The outer housing 2502 may further include an internal cavity 2512 (at its proximal end) configured to receive the adapter 312 (Figures 104-107). The outer housing 2502 may also include a second opening 2514 (formed by the two halves when the two halves of the outer housing 2502 are joined together) configured to fit around the first port 338 of the adapter 312 (Figures 104-107). The proximal end of the first port 338 may extend outward and proximal away from the proximal end 2516 of the outer housing 2502 of the knob 2500. In some embodiments, the outer housing 2502 includes a cap 2518 configured to connect around the proximal end 2516 when the first housing portion 2506 and the second housing portion 2508 are installed together, thereby connecting the first housing portion 2506 and the second housing portion 2508 to each other and forming a closed outer housing 2502 (Figures 102, 103, 106, and 107).

[0101] The outer housing 2502 may further include an extending portion 2556 that extends outward at an angle from the body of the outer housing 2502. A portion of the internal cavity 2512 may be formed within the extending portion 2556 and configured to receive the second port 340 of the adapter 312. In some embodiments, the extending portion 2556 may include a third opening 2558 (formed by the two halves when the two halves of the outer housing 2502 are joined together) configured to fit around the second portion 340 (Figures 104 and 107). The open end of the second port 340 may extend outward and away from the third opening 2558.

[0102] In an alternative embodiment, instead of receiving the adapter 312 within the internal cavity 2512, the adapter and the outer housing 2502 can be integrated together (for example, formed or molded as a single part).

[0103] Similar to the knob 314, as described above with reference to Figures 15-22, the outer housing 2502 of the knob 2500 may have one or more openings 395 disposed on the interior of the outer housing 2502 and configured to receive and engage with one or more extended portions 394 of the anchor 386 (Figures 104-106). In some embodiments, each opening 395 may be disposed within a radially extending member 2520 extending from the inner surface of the outer housing 2502 (Figures 104-106).

[0104] In some embodiments, as described above with reference to Figures 21-22, the anchor 386 may include a matching tab 399 that can extend radially outward from the anchor 386 (Figures 104 and 107). As described above and shown in Figures 104 and 107, during assembly, the matching tab 399 may be aligned with the second port 340 of the adapter 312 such that they extend outward with respect to the central longitudinal axis 320 in relatively the same direction (for example, both outward from the same side of the intermediate shaft 306, as shown in Figures 104 and 107).

[0105] In some embodiments, the knob 2500 may be assembled to the proximal end 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 Figures 15-22.

[0106] For example, in some embodiments, during assembly, the sleeve element 391 may be mounted on and / or around the proximal end portion 310 of the intermediate shaft 306. The anchor 386 may then be positioned on and around the intermediate shaft 306, adjacent to the sleeve element 391. In some embodiments, when the intermediate shaft 306 is stationary on a relatively planar surface (e.g., a table), the delivery device 300 may be positioned such that the radiopaque marker on the distal end portion 309 faces upward (e.g., away from the table), and the anchor 386 may be positioned such that the matching tab 399 faces away from the user. After this part of the matching is complete, the anchor 386 can be bonded to the intermediate shaft 306 (e.g., via UV bonding), and then the sleeve element 391 can be positioned across the radially extending portion 389 of the anchor 386.

[0107] In some embodiments, the assembly method may further include joining the adapter 312 to the intermediate shaft 306 such that the second port 340 is oriented in the same direction as the alignment tab 399, and / or the second port 340 and the alignment tab 399 are circumferentially aligned with respect to the circumference of the intermediate shaft 306. In this way, during the implantation procedure, the user can determine the initial (e.g., initiation) position of the radiopaque marker on the distal end portion 309 of the delivery device 300 in 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.

[0108] Next, the outer housing 2502 can be positioned around the anchor 386 and adapter 312 (Figures 104-107). In some embodiments, this may include positioning the first housing portion 2506 and the second housing portion 2508 around the anchor 386 and connecting them to each other, thereby connecting the distal ends of the first housing portion 2506 and the second housing portion 2508. Then, the cap 2518 can be connected to the proximal end 2516 of the knob 2500, thereby connecting the proximal ends of the first housing portion 2506 and the second housing portion 2508 to each other. These connections may allow the first housing portion 2506 and the second housing portion 2508 to be held together without the use of adhesives or additional fasteners.

[0109] In some embodiments, the outer housing 2502 may include one or more indicators 2522 (e.g., markings) that indicate to the user the direction in which the knob 2500 should be rotated to align a radiopaque marker (e.g., marker 500 or any other marker described herein) on the distal end portion of the delivery device with a guidewire extending 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 may include a printed marking with a line representing the guidewire, a visual representation of the radiopaque marker on both sides of the line (e.g., a "C" marker as shown), and arrows on both sides of the line that indicate to the user the direction in which the knob 2500 should be rotated if the radiopaque marker is not visible aligned with the guidewire in a selected imaging view during an implantation procedure (e.g., during the method in 1308, as described below with reference to Figure 57), as further described herein.

[0110] For example, to position a marker in alignment with a guidewire during an implantation procedure, if a radiopaque marker (e.g., marker 600 or another marker described herein) on the distal end portion of the delivery device appears to be on a first side of the guidewire in the fluoroscopic imaging view, the user may rotate the knob 2500 in a first direction (as indicated by the first arrow of indicator 2522), and if the radiopaque marker appears to be on the opposite second side of the guidewire in the imaging view, the user may rotate the knob 2500 in the opposite second direction (as indicated by the second arrow of indicator 2522). In some embodiments, as shown in Figures 102 and 103, each of the first housing portion 2506 and the second housing portion 2508 may include an indicator 2522, and two indicators 2522 (one on each housing portion) may be arranged 180 degrees apart from each other around the knob 2500.

[0111] In some embodiments, the presence of a knob 314 or knob 2500 for rotating the intermediate shaft 306 to achieve the desired rotational positioning of the prosthetic valve at the target implantation site may reduce the likelihood of the user firmly gripping and using the adapter 312 to rotate the intermediate shaft 306 and the prosthetic valve. Such force or torque applied to the adapter 312 may cause damage to the adapter 312. Furthermore, by completely enclosing or sealing the adapter 312 within the knob 2500, as shown in Figures 102-107, the user is prevented from firmly gripping the adapter 312 and applying torque to it.

[0112] In some embodiments, to further prevent the user from holding and rotating the adapter 312 to rotatably align the artificial valve, a portion of the adapter 312 itself may be rotatable relative to the intermediate shaft 306 and the rest of the adapter 312.

[0113] For example, Figures 23-27 show embodiments of a proximal end portion 400 of a delivery device, including an adapter 402 having a first port 404 and a second (e.g., an expanding) port 406 configured to rotate. In some embodiments, the proximal end portion 400 can be used as the proximal end portion of the delivery device 300 in Figures 9 and 14. Furthermore, in some embodiments, the proximal end portion 400 may include components similar to those described above with reference to Figures 9 and 14, and are therefore similarly labeled in Figure 23.

[0114] As shown in Figure 23, the proximal end portion 400 may include a handle (e.g., a handle portion), such as the handle 302 described above with reference to Figures 9 and 14. However, alternative handle configurations may be possible in alternative embodiments. A rotatable shaft, such as an intermediate (e.g., balloon) shaft 306, may have a proximal end portion 310 that extends distally from the handle 302 (as shown in Figures 9 and 14) and proximal to the adapter 402 (Figure 23). In addition, a rotatable knob 414 may be mounted on the proximal end portion 310 of the intermediate shaft 306 distal to the adapter 402. The knob 414 may be configured to rotate the intermediate shaft 306. In some embodiments, the knob 414 may be a knob 314, as described above with reference to Figures 15-22.

[0115] The adapter 402 may further comprise an adapter body (e.g., a body) 408. The adapter body 408 may be coupled (e.g., connected) to the proximal end portion 310 of the intermediate shaft 306 (Figures 23 and 26). For example, the adapter body 408 may include a first inner channel 410 (Figure 25) configured to receive the proximal end of the intermediate shaft 306 (Figure 26).

[0116] In some embodiments, an additional adapter 442 may be positioned around the intermediate shaft 306 between the knob 414 and the adapter body 408 (Figures 23 and 26).

[0117] The first port 404 may extend axially from the adapter body 408 (Figures 24-26). In some embodiments, the first port 404 may be directly and / or firmly coupled to a proximal portion 412 of the adapter body 408 that defines a second inner channel 416 of the adapter body 408 (Figures 25-27). For example, in some embodiments, the first port 404 and the proximal portion 412 may be joined together in a joint 444 (e.g., via welding or adhesive) (Figure 25).

[0118] In some embodiments, the first port 404 may be configured as a guidewire port adapted to receive a guidewire. For example, in some embodiments, a guidewire may be inserted into an opening 418 in the first port 404 and extend through an inner shaft 308, which is received in a second inner channel 416 and a first inner channel 410 and extends through them. For example, as shown in Figures 26 and 27, the proximal end of the inner shaft 308 may be disposed and fitted into the distal channel 420 of the first port 404 (Figures 25-27). The guidewire may then be inserted into the opening 418 and extend through the inner lumen defined by the inner shaft 308.

[0119] The second port 406 can extend radially outward from the adapter body 408 in a direction intersecting the central longitudinal axis 422 of the adapter 402 and the central longitudinal axis of the delivery device (e.g., 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 of 10 to 90 degrees from 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.

[0120] The second port 406 is rotatably coupled to the adapter body 408. For example, as shown in Figures 25-27, the second port 406 may be rotatably coupled to the proximal portion 412 of the adapter body 408. In some embodiments, the second port 406 may include a base portion 424 disposed around the proximal portion 412 of the adapter body 408.

[0121] The seal 426 can be positioned between the base portion 424 and the proximal portion 412 of the adapter body 408 (Figures 25-27). In some embodiments, the seal 426 may be a circumferential or ring-shaped seal extending around the outer surface (e.g., around the circumference) of the proximal portion 412 of the adapter body 408. In some embodiments, the seal 426 may include one or more O-ring seals or quad-ring seals.

[0122] The second port 406 may further include an internal channel (forming an internal lumen) 432 extending from an opening 428 within the second port 406 through the 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 may extend radially outward from one side of the base portion 424.

[0123] The proximal portion 412 of the adapter body 408 may include an annular groove 434 defining an annular channel 436 that extends around at least a portion of the circumference of the proximal portion 412 of the adapter body 408 (as best seen in Figures 25 and 27). In some embodiments, the annular channel 436 can fluidly couple an inner channel 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 (Figures 26 and 27).

[0124] In some embodiments, one or more openings 440 extending radially inward from the annular groove 434 can fluidly connect the annular space 438 to the inner channel 432 (Figures 25 and 27). The annular space 438 can be fluidly coupled to an 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 can extend through the thickness of the proximal portion 412 of the adapter body 408 to fluidly couple the inner channel 432 to the annular space 438.

[0125] In this way, the fluid (e.g., the expanding fluid) can flow from the inner channel 432 to the annular space 438, to the annular space 336, and into the inflatable balloon (e.g., the balloon 318 described above with reference to Figures 9-14), while the second port 406 can rotate around the adapter body 408 (e.g., around the central longitudinal axis 422). As a result, the 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 around the adapter body 408). Furthermore, rotating the second port 406 avoids the application of torque to the adapter body 408 and the first port 404, thereby increasing the durability and lifespan of the adapter 402 and preventing damage to the connection between the adapter 402 and the intermediate shaft 306. As a result, the possibility of more effective and consistent deployment of the balloon (e.g., balloon 318) via injection of the expansion fluid through the second port 406 can be increased. Furthermore, having a rotatable second port 406 allows the user to position the second port 406 in various positions (for injection of the expansion fluid) without causing unnecessary movement of the delivery device.

[0126] As described above with reference to Figures 9-27, the 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 positioned on the distal end portion of the delivery device at the target implantation site.

[0127] As described above, it may be desirable to implant the artificial heart valve into the natural valve using a delivery device (such as the delivery device 300 in Figures 9-14) so ​​that the commissures of the artificial heart valve are aligned with the commissures of the natural valve. In some embodiments, to facilitate the desired rotational positioning of the artificial heart valve relative to the natural valve, radiopaque markers visible under medical imaging may be placed on or embedded in the valve mounting portion of the delivery device (e.g., valve mounting portion 324), and thus in close proximity to the radially compressed artificial valve (such as a polymer body mounted on the distal end portion of the shaft). As further described below, in some embodiments, the radiopaque markers may be configured to indicate the location of a selected commissure of the artificial valve after the artificial valve has been radially expanded by inflating the balloon of the delivery device (e.g., balloon 318 in Figures 9-11).

[0128] Figures 28–34B show embodiments of radiopaque markers disposed on or embedded in a portion of a delivery device, such as the delivery device 300 shown in Figures 9–14. While the delivery device 300 is shown as an example in Figures 28, 29, and 32A–32B, in alternative embodiments, the radiopaque marker may be disposed on or embedded inside 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 inside may be a polymer body mounted on a shaft at the distal end of the delivery device. For example, the polymer body may be one or more of the proximal shoulder, distal shoulder (e.g., distal shoulder 326 in Figures 9–11), or the inner shaft of the delivery device and / or a nose cone mounted on another polymer body mounted on the inner shaft (e.g., nose cone 322 in Figures 9–11).

[0129] Figure 28 shows a radiopaque marker 500 positioned on and / or embedded within the polymer body of the distal end portion of a delivery device (for example, the delivery device 300 shown as an example in Figures 28 and 29). In some embodiments, as shown in Figure 28, the distal shoulder portion 326 of the distal end portion 309 of the delivery device 300 may include a marker 500 disposed on and / or embedded therein.

[0130] As shown in Figure 28 and described above with reference to Figures 9-11, the inflatable balloon 318 is positioned across (for example, overlapping) the distal shoulder 326 and the valve mounting portion 324. The nose cone 322 is positioned at the distal end of the delivery device 300, adjacent to (and distal to) the distal shoulder 326. As described above, the valve mounting portion 324 is configured around the balloon 318 to receive the prosthetic valve radially compressed on it. The distal shoulder 326 may be configured to resist axial movement of the prosthetic valve relative to the balloon 318 (along and relative to the central longitudinal axis 320 of the delivery device 300) when the prosthetic valve is mounted radially compressed on the balloon 318 in the valve mounting portion 324.

[0131] The nose cone 322 and / or distal shoulder 326 may comprise one or more polymer materials and may therefore be referred to herein as polymer bodies. In some embodiments, the distal end portion 309 of the delivery device 300 may have additional polymer bodies or components, such as a proximal shoulder disposed opposite the valve mounting portion 324 from the distal shoulder 326.

[0132] The marker 500 may be configured to be visible under medical imaging. For example, the marker 500 may include a radiopaque material configured to be visible under medical imaging such as fluoroscopy and / or other types of X-ray imaging. In some embodiments, the marker 500 may include a radiopaque or other material configured to be visible under MRI, ultrasound, and / or echocardiography. A polymer body, such as the distal shoulder portion 326 on which the marker 500 is disposed and / or embedded internally, may be configured not to be radiopaque. As a result, the marker 500 may be more readily visible under imaging, as further described below with reference to Figure 29.

[0133] In Figure 28, the marker 500 is shown positioned on and / or embedded inside the distal shoulder portion 326, but in alternative embodiments, the marker 500 may be disposed on and / or embedded inside another polymer body or component of the distal end portion 309 of the delivery device. For example, in some embodiments, the marker 500 may be positioned on and / or embedded inside the nose cone 322 or the proximal shoulder portion of the delivery device (e.g., the proximal shoulder portion 120 shown in Figure 3).

[0134] The marker 500 can have various shapes or patterns. For example, the marker 500 is shown as a dot in Figures 28 and 29, but in alternative embodiments, the marker 500 may be configured as a different shape or symbol such as a circle, rectangle, star, square, triangle, "X" shape, or equivalent. Additional embodiments of the marker shape are described below with reference to Figures 30-34B.

[0135] As shown in Figure 28, the marker 500 is positioned on and / or embedded inside a portion of the distal shoulder 326. In some embodiments, the portion of the distal shoulder 326 on which the marker 500 is positioned and / or embedded inside may be a portion of the distal shoulder 326 that is positioned closer to (e.g., adjacent to) the valve mounting portion 324 than the rest of the distal shoulder 326. Thus, when a radially compressed prosthetic valve is positioned on the valve mounting portion 324, the marker 500 may be positioned close to and adjacent to the prosthetic valve.

[0136] In some embodiments, as shown in Figure 28, the distal shoulder portion 326 may comprise a base portion 325 and a wide-mouth portion 331. The wide-mouth portion 331 may extend radially outward from the base portion 325 toward the valve mounting portion 324. The marker 500 is positioned on and / or embedded inside the wide-mouth portion 331, thereby allowing the marker 500 to be oriented radially outward from the outer surface of the inner shaft 308. In alternative embodiments, the marker 500 may be positioned on and / or embedded inside the base portion 325.

[0137] In some embodiments, as shown in Figure 28, the wide-mouth section 331 may comprise a plurality of wings 330 (also referred to as extensions) extending radially outward from the base section 325 at an angle to the central longitudinal axis 320. The wings 330 may be spaced apart from each other around the circumference of the wide-mouth section 331. As shown in Figure 28, in some embodiments, the marker 500 may be positioned on or embedded in one of the wings 330. In some embodiments, the marker 500 may be centered on one of the wings 330 so as to be centered along the central longitudinal axis 320.

[0138] In some embodiments, the marker 500 may be a single (e.g., only) radiopaque marker disposed on the distal shoulder portion 326. In some embodiments, the marker 500 may be a single (or only) radiopaque marker disposed on the distal end portion 309 of the delivery device 300.

[0139] In some embodiments, the distal end portion 309 of the delivery device 300 may include an additional radiopaque marker (in addition to the marker 500).

[0140] Placing the marker 500 on or within another polymer body of the distal shoulder 326 or the distal end portion of the delivery device may allow the marker 500 to be more visible under imaging such as fluoroscopy, because other portions of the distal shoulder 326 may not be very radiopaque or radiopaque, and therefore may not be very visible or invisible in fluoroscopic images. For example, as shown in the exemplary fluoroscopic image 550 of Figure 29, the marker 500 is visible under fluoroscopy and stands out because the distal shoulder (other than the marker 500) is not radiopaque. In contrast, the prosthetic valve frame 552 is radiopaque and visible under imaging. Therefore, because the valve frame appears relatively dark in image 550, the radiopaque marker positioned on and / or within the prosthetic valve itself may be less visible under imaging.

[0141] As also shown in Figure 29, the guidewire 554 extending through the center of the distal end portion 309 of the delivery device (e.g., through the medial lumen of the medial shaft 308) is visible under fluoroscopy, and the marker 500 is positioned radially outward of the guidewire 554 (e.g., because the marker 500 is located on the wide-mouth portion 331 of the distal shoulder portion 326). This further increases the visibility of the marker 500 under imaging during the implantation procedure. In addition, as will be further described below, when the marker 500 is positioned directly behind or directly in front of the imaging view, the marker 500 may appear to overlap with the guidewire.

[0142] In addition, positioning the marker 500 on or within the distal shoulder portion 326 (or another polymer body of the distal end portion of the delivery device) may enable more precise alignment with the natural valve commissure. For example, as further described below, it may be desirable to rotationally align the marker 500 with the target commissure of the natural valve before traversing the leaflets of the natural valve. Therefore, when rotating the distal end portion 309 of the delivery device, including the distal shoulder portion 326 and the prosthetic valve, to align the marker 500 with the target commissure of the natural valve, it may be advantageous to position the marker 500 as distally as possible on the delivery device so that it is positioned as close to the target commissure of the natural valve as possible. As shown in Figure 28, the distal shoulder portion 326 (and nose cone 322) is one of the most distal components of the delivery device 300 and is positioned further distal to the radially compressed prosthetic valve (for example, further distal to the valve mounting portion 324, as seen in Figure 28).

[0143] Placing the marker 500 on or within the distal shoulder portion 326 (or another polymer body of the delivery device positioned axially offset from the prosthetic valve) also allows the marker 500 to be circumferentially offset from the selected commissure of the prosthetic valve. For example, as further described below, since the prosthetic valve rotates when the expandable balloon 318 is inflated, the marker 500 may be circumferentially offset from the selected commissure of the prosthetic valve to compensate for this rotation. As a result, after deployment of the prosthetic valve, the selected commissure of the prosthetic valve may be aligned with the target commissure of the natural valve. If the prosthetic valve itself has an offset marker, this can be confusing after valve deployment because the marker is visible but does not actually mark the selected commissure of the prosthetic valve.

[0144] Furthermore, providing the marker 500 on or within the distal shoulder portion 326 (or another portion of the delivery device adjacent to the valve mounting portion 324) can avoid the need to add additional components to a relatively permanent implant (e.g., a prosthetic valve). In addition, changes to the marker 500 on the delivery device (e.g., design changes) can be implemented more easily in the delivery device than when the marker 500 is on the valve (e.g., due to valve testing resulting from any design modifications to the prosthetic valve).

[0145] During the implantation procedure, the distal end portion of the delivery device, including the marker 500 and the radially compressed prosthetic valve (e.g., frame 552), can be visualized relative to the surrounding natural anatomical structures using a selected imaging view (e.g., a fluoroscopic imaging view). Based on existing knowledge of the location of the selected commissure of the natural valve (where the prosthetic valve will be implanted) within the selected imaging view, the user can rotate-align the distal end portion of the delivery device at the target implantation site so that the marker 500 aligns with the known location of the selected commissure within the selected imaging view, or so that the marker 500 is positioned at a specific location within the selected imaging view (e.g., directly posterior) and deploying the prosthetic valve in such orientation results in commissure alignment between the prosthetic valve and the natural valve.

[0146] For example, in some imaging views, a selected commissure of the natural valve may be positioned directly behind the imaging view. Thus, by aligning the marker 500 on the delivery device with the direct rear of the imaging view, the prosthetic valve can be implanted within the natural valve with commissure alignment between the natural valve and the prosthetic valve. Exemplary fluoroscopic imaging views acquired during the prosthetic valve implantation procedure and used to guide the delivery device in close proximity to the natural valve are shown in Figures 58, 61, and 63, as will be further described below.

[0147] To enable the desired positioning of the marker within the selected imaging view, in some embodiments the marker may be configured as an asymmetric marker, which is then aligned with a guidewire extending through the delivery device along the central longitudinal axis of the delivery device. For example, the asymmetric marker may be reflectively asymmetric along an axis parallel to the central longitudinal axis of the delivery device. In this way, the position of the marker in the imaging view relative to the guidewire (e.g., front vs. back of the imaging view) can be more easily identified under medical imaging such as fluoroscopy.

[0148] Figures 30–34B illustrate exemplary embodiments of such asymmetric markers that allow a user to distinguish between two different positions of a marker in an imaging view. For example, in some embodiments, the asymmetric markers are configured so that a user viewing the imaging view can distinguish between a marker positioned in front of or behind the fluoroscopic imaging view. The markers shown in Figures 30–34B may be positioned on the delivery device as described above with reference to Figures 28 and 29. For example, in some embodiments, the markers shown in Figures 30–34B may replace a marker 500 (Figures 28 and 29) on an alternative polymer body of the distal shoulder portion 326 or the distal end portion 309 of the delivery device.

[0149] In some embodiments, the asymmetric marker may be an alphabetical letter (e.g., as shown in Figures 30-34B), a number, a symbol, a shape, or equivalent, which is reflectively asymmetric along an axis parallel to the central longitudinal axis of the delivery device. For example, the asymmetric marker may have a first orientation in which it can be read "correctly" or facing forward (e.g., not backward), and a second orientation rotated about 180 degrees around the axis from the first orientation, causing the marker to appear backward to the reader (e.g., the user).

[0150] Figure 30 shows a first exemplary embodiment of an asymmetric marker 600, which is shaped as the letter "C" and can be configured similarly to the marker 500 (e.g., radiopaque) in Figure 28. The C-shaped asymmetric marker 600 is reflect-asymmetric across a longitudinal axis 602, which is parallel to the central longitudinal axis of the delivery device (e.g., delivery device 300) when positioned on the delivery device, as described above with reference to Figure 28. For example, in Figure 30, the C-shaped asymmetric marker 600 is in a first orientation, which is its forward-readable orientation (e.g., appearing in its correct orientation, not facing backward to the reader). If the C-shaped asymmetric marker 600 is rotated about 180 degrees around its longitudinal axis 602, the C-shaped asymmetric marker 600 will be in a second orientation, and the "C" will appear facing backward (e.g., inverted). These two orientations of the C-shaped asymmetric marker 600 can be seen in a medical imaging view (e.g., using fluoroscopy), as further described herein. The two orientations of a C-shaped asymmetric marker (and other asymmetric markers described herein) can be mirror images of each other.

[0151] Figures 31A and 31B show exemplary fluoroscopic images 610 and 612 of a guidewire 606 extending through the distal end portion of a delivery device (e.g., the distal end portion 309 of the delivery device 300) and a C-shaped asymmetric marker 600 positioned on or embedded inside a portion of the distal end portion of the delivery device (e.g., the distal shoulder portion 326, as shown in Figure 28), respectively. As shown in the first fluoroscopic image 610 of Figure 31A, the C-shaped asymmetric marker 600 is aligned with (e.g., overlaps with) the guidewire 606, and the "C" is readable in its first (forward) orientation. In some embodiments, this position of the marker 600 shown in Figure 31A may indicate that the marker 600 is positioned behind the guidewire 606 in a first fluoroscopic imaging view 610, and therefore directly behind the imaging view. In an alternative embodiment, the position of the marker shown in Figure 31A may indicate that the marker is positioned in front of the guide wire 606 and therefore directly in front of the imaging view.

[0152] In contrast, when the delivery device is rotated approximately 180 degrees from its orientation shown in Figure 31A, the C-shaped asymmetric marker 600 rotates accordingly and appears in its second (rear) orientation with the "C" facing backward, as shown in Figure 31B. In some embodiments, the position of the marker 600 shown in Figure 31B may indicate that the marker 600 is positioned in front of the guide wire 606 in the imaging view, and therefore directly in front of the imaging view. In alternative embodiments, the position of the marker 600 shown in Figure 31B may indicate that the marker is positioned behind the guide wire 606, and therefore directly behind the imaging view.

[0153] In this way, by visualizing the orientation of a reflective asymmetric marker, such as marker 600, relative to the guidewire 606 within the selected imaging view, the position of marker 600 at the implantation site (e.g., close to the target natural valve) can be determined more easily and quickly. Further details on rotationally aligning the marker with the guidewire so that the prosthetic valve is implanted with the commissure aligned with the commissure of the natural valve are described below with reference to Figures 57-60.

[0154] Figures 32A and 32B show a side view and a perspective view, respectively, of exemplary positioning of an asymmetrical marker 600 (shaped as the letter "C") located on and / or embedded inside the distal shoulder portion 326 of the distal end portion 309 of the delivery device 300. As shown in Figures 32A and 32B, the marker 600 may be positioned on the distal shoulder portion 326 (for example, on the wing 330 in some embodiments) such that when the delivery device is deployed within the patient's vascular system and a longitudinal imaging view similar to the view in image 550 of Figure 29 is used to visualize the delivery device, the C-shape of the marker 600 is read in a backward orientation when the marker 600 is directly in front of the imaging view, and the marker 600 is read in a forward orientation when the marker 600 is positioned directly behind the imaging view.

[0155] In an alternative embodiment, the marker 600 may be oriented on the distal shoulder, different from that shown in Figures 32A and 32B, such that the marker 600 is rotated 180 degrees and read in a forward orientation instead when the marker 600 is directly in front of the imaging view.

[0156] Figures 33–34B show a second exemplary embodiment of the asymmetric marker 650, which is shaped as the letter "E" and can be configured similarly to the marker 500 in Figure 28 (e.g., radiopaque). Figure 33 shows the E-shaped asymmetric marker 650 alone, while Figures 34A and 34B show fluorescence fluoroscopy images of the E-shaped asymmetric marker 650 on a delivery device in two different orientations relative to the guidewire 606.

[0157] The E-shaped asymmetric marker 650, aside from its overall shape (for example, E-shaped instead of C-shaped), can be configured and function similarly to the marker 600, as described above with reference to Figures 30-32B. For example, the E-shaped asymmetric marker 650 may be reflectively asymmetric across a longitudinal axis 652 that is parallel to the central longitudinal axis of the delivery device when positioned on the delivery device.

[0158] Similar to marker 600, the E-shaped asymmetric marker 650 has a first orientation, which is its forward (or "correct") readable orientation (as shown in the first image 654 of Figures 33 and 34A). The E-shaped asymmetric marker 650 also has a second orientation, which is rotated approximately 180 degrees around its longitudinal axis 652 from the first orientation. In the second orientation, the "E" appears backward (as shown in the second image 656 of Figure 34B). These two orientations of the E-shaped asymmetric marker 650 are shown in Figures 34A and 34B and can be observed using medical imaging (e.g., fluoroscopy) as further described herein.

[0159] In some embodiments, the E-shaped asymmetrical marker 650 can replace the marker 600 on the delivery device shown in Figures 32A and 32B.

[0160] In yet another embodiment, the asymmetric marker may be formed as another letter (such as "P" or "F" other than "C" or "E"), a number, a symbol, a shape, or an equivalent, which is reflectively asymmetric and has two distinguishable orientations when rotated about 180 degrees around its reflectively asymmetric axis, as described above.

[0161] In some embodiments, asymmetrical markers (e.g., marker 600 or marker 650) disposed on or embedded inside the distal end portion (such as the distal shoulder portion 326) of the delivery device may include a radiopaque material. In some embodiments, the radiopaque material includes a metal.

[0162] In some embodiments, the asymmetric markers described herein may include tantalum. In some embodiments, the asymmetric markers described herein may include other types of radiopaque materials or combinations of materials, such as one or more of iodine, barium, barium sulfate, tantalum, bismuth, or gold.

[0163] In some embodiments, the asymmetric markers described herein may include a platinum-iridium alloy. In some embodiments, the alloy ratio of the platinum-iridium alloy is 90:10. In some embodiments, the alloy ratio of the platinum-iridium alloy is in the range of 75:25 to 95:5. In some embodiments, the alloy ratio of the platinum-iridium alloy is in the range of 85:15 to 95:5.

[0164] In some embodiments, instead of being positioned on the distal end portion of the delivery device, or in addition to that, radiopaque markers can be positioned on or near the prosthetic valve, such as on or near the commissures of the prosthetic valve, as shown in Figures 35A–35P and 97–101E. As a result, the location of a selected commissure of the radially compressed prosthetic valve can be identified by medical imaging during the valve implantation procedure and rotationally aligned with the natural anatomical structure at the target implantation site.

[0165] In embodiments where radiopaque markers are positioned both on the distal end portion of the delivery device (as described above) and on the prosthetic valve (at or near the commissure, as described below), the first radiopaque marker on the delivery device can be visualized during the valve implantation procedure to rotate-align the first marker with the natural anatomical structure and deploy the prosthetic valve so that its commissure aligns with the commissure of the natural valve. A second radiopaque marker on the prosthetic valve can then be visualized after implantation (e.g., during future interventions to locate the prosthetic valve commissure and / or to confirm the location of the prosthetic valve commissure relative to the natural valve commissure). In some embodiments, the second radiopaque marker at the commissure of the prosthetic valve can be more easily visualized after radial expansion of the prosthetic valve (post-implantation).

[0166] Exemplary embodiments of a radiopaque marker 700 attached to the commissure 702 of a prosthetic valve 704 (which may be similar to any of the prosthetic valves described herein, such as the prosthetic valve 10 in Figure 1 or the prosthetic valve 50 in Figures 2A and 2B) are shown in Figures 35A and 35B. Figure 35A shows the prosthetic valve 704 in a radially compressed configuration (e.g., state) such as when it is arranged around a delivery device and crimped thereon, and Figure 35B shows the prosthetic valve 704 in a radially expanded configuration (e.g., state).

[0167] As introduced above with reference to Figures 2A and 2B, and as shown in Figures 35A and 35B, in some embodiments, the commissure 702 of the artificial valve 704 may comprise a mounting member 706 disposed across a cell (e.g., commissure cell) 708 of the frame 710 of the artificial valve 704. In some embodiments, the mounting member may include a fabric, flexible polymer, or equivalent disposed across the cell 708. As described herein, the cell 708 may be formed by a support 712 of the frame 710. The mounting member 706 is disposed across the cell 708 and may be fixed to the support 712 of the frame 710 forming the cell 708 via fasteners 714 (e.g., sutures). In addition, adjacent portions of two valve leaflets 716 of the artificial valve 704 can be connected to the mounting member 706 to form the commissure 702.

[0168] In some embodiments, the commissar tabs of two adjacent valve leaflets 716 are coupled to the mounting member 706 on its inner surface (shown in Figure 35E, as described below), and the marker 700 is positioned on the outer surface 724 of the mounting member 706. The inner surface may be positioned opposite the outer surface 724, facing the interior of the artificial valve 704.

[0169] In some embodiments, as shown in Figures 35A and 35B, the marker 700 may be positioned on the central region of the commissar cell 708. For example, in some embodiments, the marker 700 may be sewn to the central region of the mounting member 706 via one or more fasteners (e.g., sutures) 722.

[0170] In some embodiments, the marker 700 may be molded and positioned to fit within the cell 708 when the frame 710 is in a radially compressed configuration, as shown in Figure 35A.

[0171] In some embodiments, the commutating cell 708 may be located at the outflow end 718 of the artificial valve 704.

[0172] In some embodiments, the marker 700 includes tantalum or another radiopaque material described herein or known in the art, which is formed or laser-cut into a shape that is reflectively asymmetrical across the axis, similar to those described above with reference to Figures 28-34B.

[0173] In some embodiments, the artificial valve 704 includes a skirt 720 (Figure 35B) disposed around the frame 710 of the artificial valve 704 at the inlet end of the artificial valve 704 (for example, the end located opposite the outlet end 718). In Figures 35A and 35B, when the commissure cell 708 is located at the outlet end 718 of the artificial valve 704, the commissure cell 708, including the marker 700, may be axially separated from the skirt 720.

[0174] Figures 35C–35H show another exemplary embodiment of the attachment of a radiopaque marker 750 to the commissure within cell 708 of an artificial valve. The artificial valve shown in Figures 35C–35H may be the same artificial valve 704 shown in Figures 35A and 35B, and therefore Figures 35C–35H are labeled accordingly. However, in Figures 35C–35H, there are two attachment members that are arranged across cell 708 and attached to the struts 712 that form cell 708. The commissure tab 754 of the valve leaflet 716 and the marker 750 may be sutured to different attachment members of the two attachment members.

[0175] For example, the mounting member 706 to which the connecting tab 754 of the valve leaflet 716 is attached may be the first mounting member 706 (Figures 35C, 35D, and 35H), and the marker 750 may be attached to the second mounting member 752 (Figures 35C to 35G).

[0176] Marker 750 may be similar to marker 700 and other radiopaque markers described herein. For example, marker 750 may be configured (e.g., molded and sized) to fit within cell 708 when frame 710 is in a radially compressed configuration (as shown, for example, in Figure 35A).

[0177] An exemplary embodiment of the marker 750 is shown in Figure 35I. The marker 750 may be oval-shaped, having a first (upper) opening 726 and a second (lower) opening 728 configured to receive fasteners (e.g., sutures) for securing the marker 750 to a mounting member, as will be further described below. In some embodiments, the marker may include more than two or fewer than two openings (e.g., one, three, four, or equivalent) for receiving fasteners. In some embodiments, the marker 750 may have different shapes 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 (see, for example, Figures 35A, 35B, and 35J-35P).

[0178] In some embodiments, the marker 750 may be shaped as an alphabetical character (for example, as shown in Figures 35A and 35B).

[0179] In some embodiments, the marker 750 may be reflectively asymmetric across an axis parallel to the central longitudinal axis 760 of the frame 710 (as shown, for example, in Figures 35A and 35B).

[0180] As shown in Figure 35C, the first mounting member 706 can be fixed to the support 712 forming the cell 708 via fasteners (e.g., sutures) 714. The commissar tabs 754 of two adjacent valve leaflets 716 can be coupled to the first mounting member 706 on its inner surface 756, as shown in Figure 35H (the commissar tabs 754 are identified by region 755 in Figure 35C). For example, the commissar tabs 754 can be sutured directly to the inner surface 756 of the first mounting member 706, or through one or more intervening layers of fabric between the commissar tabs 754 and the first mounting member 706.

[0181] Furthermore, as shown in Figure 35C, the marker 750 is secured to the second mounting member 752 via one or more fasteners 758 (e.g., sutures) that can extend through the first opening 726 and the second opening 728 of the marker 750 (Figure 35I). In some embodiments, the marker 750 may be sewn to the central region of the second mounting member 752 using the fasteners 758.

[0182] In other embodiments, the marker 750 may have a number of other openings or different shapes configured to receive fasteners 758 for securing the marker 750 to the second mounting member 752. For example, in some embodiments, the marker 750 may be ring-shaped (e.g., molded as the letter "O").

[0183] Figure 35C shows the marker 750 attached to the second mounting member 752, but before the second mounting member 752 is assembled to the frame 710. Figure 35G shows the marker 750 and the second mounting member 752 after the second mounting member 752 has been positioned in the commissar cell 708 so that the marker is positioned between the first mounting member 706 and the second mounting member 752 and sutured to the frame support with one or more sutures 762. Thus, the opposite side of the second mounting member 752 is shown in Figures 35C and 35G.

[0184] In some embodiments, as shown in Figure 35G, the second mounting member 752 may be positioned relative to the frame 710 such that the exposed metal material of the marker 750 faces the outer surface 724 of the frame 710 and the first mounting member 706.

[0185] Therefore, when the second mounting member 752 is positioned across the cell 708 as shown in Figure 35G and attached to the support column 712 forming the cell 708, the marker 750 can be sandwiched (e.g., positioned) between the second mounting member 752 and the first mounting member 706.

[0186] In some embodiments, the second mounting member 752 may be similar to or include the same fabric material as the first mounting member 706.

[0187] In some embodiments, the second mounting member 752 can be fixed to the support column 712 via additional fasteners (e.g., sutures).

[0188] In other embodiments, as shown in Figures 35D-35F, the second mounting member 752 and the first mounting member 706 can be simultaneously fastened to the support column 712 using the same fastener (e.g., suture 762). For example, in some embodiments, after fastening the commissural tabs 754 of two adjacent valve leaflets 716 to the first mounting member, the upper portion of the first mounting member 706 can be first fastened to the upper support column 712 of the cell 708 using the first suture 762a (Figure 35D). The second mounting member 752 can then be aligned with the first mounting member 706 with the marker 750 fixed to it (Figures 35D and 35E). Next, the first stitch 762a passes around the support 712 on the first side surface of the cell 708 through both the first mounting member 706 and the second mounting member 752 (Figures 35D-35G), thereby forming a single load-bearing stitch line from the top to the bottom of the cell 708. Similarly, the second stitch 762b passes around the support 712 on the second side surface of the cell 708 through both the first mounting member 706 and the second mounting member 752 (Figures 35E-35G), thereby forming another load-bearing stitch line from the top to the bottom of the cell 708.

[0189] In this way, the second mounting member 752 is positioned outside the first mounting member 706 with respect to the outer surface of the frame 710 and the central longitudinal axis 760 of the frame 710 (Figure 35C). As a result, metal-to-metal contact between the marker 750 and the frame 710, and / or any abrasive contact between the marker 750 and the outside of the frame 710 (e.g., the outer surface) can be avoided. Furthermore, by fixing the marker 750 to the outer second mounting member 752, contact between the marker 750 and the valve leaflet (which is fixed to the inner first mounting member 706) is also avoided.

[0190] In some embodiments, the marker 750 can be fixed to the strut 712 in a stitching pattern that avoids the tissue of the valve leaflet 716. In some embodiments, additional material provided by the second mounting member 752 also protects the tail of the knot and suture used to fix the commissure tab 754 to the first mounting member 706, thereby making the commissure more robust and durable.

[0191] As described above, due to its position on the frame 710 and its radiopaque nature, the marker 750 can provide identification (e.g., visibility) of the commissure during the implantation procedure, thereby enabling the desired commissure alignment as described herein. Furthermore, such a radiopaque marker 750 can also provide identification of the location of the commissure of the prosthetic valve post-implantation and during any future interventional procedures.

[0192] Figures 35J–35P show additional embodiments of radiopaque markers configured to be attached to the commissure within cell 708 of the prosthetic valve, or to an additional mounting member attached to cell 708, or (as shown in Figure 35L) to an additional skirt or fabric material directly below the location of the commissure. For example, in some embodiments, any of the markers shown in Figures 35J–35P can replace a marker 700 on the prosthetic valve 704 (Figures 35A–35B) or a marker 750 on a second mounting member 752 (Figures 35C–H). Furthermore, any of the markers shown in Figures 35A–35P may be attached to an additional skirt or fabric material directly and / or axially below the location of the commissure (as shown in Figure 35L).

[0193] The exemplary markers shown in FIGS. 35J - 35P have different shapes or configurations. In some embodiments, the shape of the marker and / or the mounting location on the valve for the marker can be selected based on the geometric shape and spatial limitations of the valve (e.g., the size of the cells of the frame). In certain embodiments, one or more of the markers shown in FIGS. 35J - 35P can be shaped and sized to fit within the cell 708 both when the frame 710 of the prosthetic valve is in its radially compressed configuration and its radially expanded configuration.

[0194] FIG. 35J shows an exemplary embodiment of a radiopaque marker 766 fixed to a mounting member 706 disposed across the cell 708 of the frame 710 using one or more fasteners (e.g., suture) 768. As shown in FIG. 35J, the marker 766 is in an arc shape, with its longest dimension disposed circumferentially (e.g., across the width of the cell 708). However, in alternative embodiments, the marker 766 can be oriented differently within the cell 708, such as having its longest dimension axially (e.g., as shown in FIG. 35L as described below).

[0195] FIG. 35K shows an exemplary embodiment of a radiopaque marker 770 fixed to a mounting member 706 disposed across the cell 708 of the frame 710 using one or more fasteners (e.g., suture) 772. The marker 770 is annular or “o”-shaped. For example, the marker 770 can include a central opening 771, and one or more fasteners 772 can extend through the central opening 771, around the marker 770, and through the material of the mounting member 706. In some embodiments, the marker 770 can be centered on the mounting member 706.

[0196] FIG. 35L shows an exemplary embodiment of a radiopaque marker 774 fixed to an attachment member 706 disposed across a cell 708 of a frame 710 using one or more fasteners (e.g., suture) 775 and a radiopaque marker 776 fixed to one or more skirts 778 extending across the inner surface of the frame 710 using one or more fasteners (e.g., suture) 780. In some embodiments, each of the one or more skirts 778 may be fixed to the valve leaf edge of a corresponding valve tip 716 and may include a plurality of skirts 778 folded to extend across a strut 712 of the frame 710 disposed between the valve leaf edges of adjacent valve tips 716. Thus, in some embodiments, marker 776 may be fixed to an overlapping portion 782 of two adjacent skirts 778 disposed axially below the commissure 702. In certain embodiments, the prosthetic valve 704 may have only one of markers 774 and 776 fixed to the frame 710. As shown in the embodiment of FIG. 35L, markers 774 and 776 are disposed to extend in the direction of the central longitudinal axis 760 of the frame 710 of the prosthetic valve 704 (e.g., the longest dimension of markers 774 and marker 776 extends axially with respect to the central longitudinal axis 760. Marker 774 may be the same as or similar to marker 766 shown in FIG. 35J, but rotated such that its longest dimension extends axially.

[0197] Each of markers 766, 770, 774, and 776 (FIGS. 35J - 35L) can include one or more mounting openings 784 configured to receive one or more fasteners (e.g., fasteners 768, 772, 775, or 780) for fixing the marker to the attachment member 706 or one or more skirts 778. As shown in FIGS. 35J - 35L, the mounting openings 784 can be circular. However, in alternative embodiments, the mounting openings 784 can have different shapes (e.g., oval, rectangular, triangular, or the like) and / or sizes (e.g., a diameter or width smaller than the width of the marker).

[0198] Figures 35M–35P show additional exemplary embodiments of radiopaque markers that are reflectively asymmetrical along an axis parallel to the central longitudinal axis of the frame 710 of the artificial valve 704. As a result, the markers shown in Figures 35M–35P can provide an indicator of the position of the commissure 702 relative to the guidewire (as described herein) under fluoroscopic imaging.

[0199] For example, Figure 35M shows an exemplary embodiment of a radiopaque marker 786 fixed to a mounting member 706 positioned across a cell 708 of a frame 710 using one or more fasteners (e.g., sutures) 787. The marker 786 includes an elongated notch or opening 789 positioned on a first side of the marker 786 (with respect to the central longitudinal axis 790 of the marker 786). Thus, on a second side opposite the marker 786 (crossing the axis 790), the marker 786 includes a solid material portion 791. One or more fasteners 780 extend through the opening 789 around the marker 786 and within the mounting member 706. Because the solid material portion 791 and the opening 789 are positioned on the opposite side of the marker 786 with respect to the axis 790, the marker 786 is reflector-asymmetric across the axis 790.

[0200] Figure 35N shows another exemplary embodiment of a radiopaque marker 792, configured similarly to marker 786 (Figure 35M), fixed to a mounting member 706 positioned across a cell 708 of a frame 710 using one or more fasteners (e.g., sutures) 787. For example, marker 792 also includes an opening 789 positioned across the axis 790 of marker 792 from a solid material portion 791. However, the opening 789 and solid material portion 791 of marker 792 are molded differently from those of marker 786 (e.g., more elongated).

[0201] In certain embodiments, the markers described above may be fixed to the mounting member 706 within the region of the leaflet tissue (as shown in Figure 35H, the commissure tab 754 of the leaflet 716) or to the leaflet tissue itself. For example, the commissure tab below the leaflet 716 of the commissure 702 is represented in the figure as a central region with more oblique parallel lines on the mounting member 706. In some embodiments, the markers may be attached to the mounting member 706 outside this tissue region, thereby avoiding the placement of additional fasteners or sutures within the tissue of the leaflet commissure tab.

[0202] Figures 35O and 35P show exemplary embodiments of radiopaque markers fixed to an additional mounting member (which may be, for example, a cloth), the additional mounting member being fixed to the mounting member 706 outside the underlying tissue region 799. For example, Figure 35O shows an exemplary embodiment of a radiopaque marker 794 fixed to an additional mounting member 793 by one or more fasteners (e.g., sutures) 797 that may extend through a central opening (or notched region) 795 within the marker 794. The additional mounting member 793 may be fixed directly to the mounting member 706 outside the tissue region 799 by one or more fasteners (e.g., sutures) 796. As a result, the marker 794 can be fixed to the mounting member 706 through the additional mounting member 793 without the marker 794 itself being fixed to the mounting member 706.

[0203] Similarly, Figure 35P shows another exemplary embodiment of a radiopaque marker 794 secured to an additional mounting member 798 by one or more fasteners (e.g., sutures) 797 that can extend through a central opening (or notched area) 795 within the marker 794. The additional mounting member 798 can then be directly secured to the mounting member 706 by one or more fasteners 796. As shown in Figures 35O and 35P, the additional mounting member 798 has a rhomboid shape, while the additional mounting member 793 has a rectangular shape. Alternative shapes of the additional mounting member are possible (e.g., circular, square, and equivalent).

[0204] As shown in Figures 35A and 35B, an exemplary method for attaching a radiopaque marker 750 (or any other radiopaque marker described herein) to a mounting member configured to be attached to the commissure tabs of two adjacent valve leaflets (thus forming a commissure) and fixed to the support 712 of the cell 708 of the artificial heart valve frame 710 is presented in Figures 97-101E.

[0205] Figures 97–99B show one embodiment in which a radiopaque marker 750 is directly attached (e.g., sewn) to a mounting member 730. As shown in Figure 97, the mounting member 730 may comprise first and second lateral portions 732a, 732b projecting laterally from a central portion 734 (or central region). The mounting member 730 may further comprise an upper tab 736 and a lower tab 738 projecting from the upper and lower edges of the central portion 734, respectively. Further details regarding mounting members for securing commissure tabs of adjacent valve leaflets to cells of the artificial valve frame are described in U.S. Patent Publication 2018 / 0028310, which is incorporated herein by reference.

[0206] As shown in Figure 97, the marker 750 is directly secured to the central portion 734 of the mounting member 730 by one or more sutures 740 (forming one or more knots on the outside of the marker 750). The mounting member 730 can then be folded and secured to the commissural tab of the valve leaflet so that the marker 750 is positioned on either the radially outward-facing surface 742 of the mounting member 730 (e.g., facing outward from the valve leaflet) (Figures 98A and 98B) or the radially inward-facing surface of the mounting member 730 (e.g., the surface located opposite the radially outward-facing surface 742 and facing the commissural tab of the valve leaflet) (Figures 99A and 99B). For example, when the marker 750 is secured to the radially outward-facing surface 742 of the mounting member 730, when secured to the cell 708, the marker 750 faces outward away from the inside of the valve leaflet and frame 710 (Figure 98B). In contrast, when the marker 750 is fixed to the radially inward-facing surface of the mounting member 730, and fixed to the cell 708, the marker 750 faces inward toward the valve leaflet (Figure 99B). Therefore, as shown in Figures 99A and 99B, the marker 750 is positioned behind the mounting member 730.

[0207] Figures 100–101E show another embodiment in which the radiopaque marker 750 is attached (e.g., sewn) to the elongated flap 744 (or extension) of the mounting member 746. As shown in Figure 100, the mounting member 746 is similar to the mounting member 730 in Figure 97, except that it has a longer flap 744 extending from the central portion 734 (instead of a shorter upper tab 736). As shown in Figures 101A–E, the marker 750 may be attached to the flap 744 and the commissure formed with the mounting member 746 (such as the commissure 702 shown in Figures 32A and 32B) by one or more sutures (or other similar fasteners) used to secure the commissure tabs of adjacent valve leaflets to the mounting member 746 (as shown in Figure 35H).

[0208] For example, the marker 750 may be positioned on the first surface 748 of the flap 744 across one or more openings within the flap 744 (the marker 750 is shown as transparent for illustrative purposes in Figure 100). In the embodiments of Figures 100-101E, the flap 744 may be spaced apart based on the distance between the first opening 726 and the second opening 728 of the marker 750 (for example, the first opening 726 overlaps the first opening 701 and the second opening 728 overlaps the second opening 703), and may include two openings, including a first opening 701 and a second opening 703.

[0209] Next, the flap 744 can be folded over the outer surface 705 of the central portion 734 of the mounting member 746, over sutures extending outward from the outer surface 705, which were used to connect the commissural tabs of adjacent valve leaflets to the mounting member 746 (Figure 101A). Thus, the marker 750 is sandwiched between the second surface (outer surface) 707 of the flap 744 and the outer surface 705 of the central portion 734 of the mounting member 746 (Figure 101A).

[0210] Next, the first suture 709 can be routed through the second opening 728 of the marker 750 and through the second opening 703 within the flap 744 so as to extend outward away from the second surface 707 of the flap 744 (Figure 101B). Next, the second suture 711 can be routed through the first opening 726 of the marker 750 and through the first opening 701 within the flap 744 so as to extend outward away from the second surface 707 of the flap 744 (Figure 101B).

[0211] In some embodiments, the free end of the first suture 709 can be routed through a loop-shaped portion 713 of the first suture 709 that is positioned on each side of the flap 744 below the flap 744 (Figure 101C). The first suture 709 is then tightened against the flap 744, as shown in Figure 101D.

[0212] Next, the free (untied) ends of the first suture 709 can be tied together to secure the first portion of the marker 750 (the upper portion in Figures 101A to 101E) to the mounting member 746. Then, the free (untied) ends of each second suture 711 can be tied together using the corresponding third suture 717 (of a pair of third sutures 717 arranged beneath the flap 744) to secure the second (e.g., bottom) portion of the marker 750 to the mounting member 746 (Figure 101E).

[0213] In some embodiments, the first suture 709 can be tied with one single and one double knot to form the first knot portion 715 (Figure 101E). Each second suture 711 can be tied with one single and two double knots using the corresponding third suture 717 to form the second knot portion 719 and the third knot portion 721 on the opposite side of the first opening 701 (Figure 101E).

[0214] In this way, the marker 750 can be fixed to the flap 744 of the mounting member 746 using the same suture (or similar fixing member) used to fix the commissure tabs of adjacent valve leaflets to the inner surface of the mounting member 746. This simplifies the assembly process of the artificial heart valve, thereby saving time and assembly costs.

[0215] As described above, an artificial valve can be mounted around the valve mounting portion of the distal end of a delivery device (e.g., the valve mounting portion 324 of the delivery device 300 shown in Figures 9-11 and 32A-32B) and radially compressed (e.g., crimped) on top of it for delivery of the valve to a target implantation site (e.g., a natural valve of the heart). In some embodiments, the inflatable balloon of the delivery device (e.g., the balloon 318 shown in Figures 9-11 and 32A-32B) is pleated and wound in a manner that more efficiently folds the balloon material to minimize the diameter of the folded balloon. As a result, the diameter of the artificial valve crimped on the folded balloon in a radially compressed configuration can also be minimized.

[0216] Figure 36 shows an embodiment of an inflatable balloon 818 folded around the distal end portion 809 of the delivery device 800. The delivery device 800 may be similar to the delivery device 300 of Figures 9-11 and includes one or more shoulder portions 802 mounted on an inner shaft 808, the inner shaft extending distally from an intermediate (e.g., balloon) shaft 806. The balloon 818 overlaps the valve mounting portion 824 of the distal end portion 809 of the delivery device 800. A portion of the balloon 818 in the valve mounting portion 824 may include one or more axially extending folds or pleats 830. Such axial pleats 830 can be tightly compressed to minimize the external shape of the balloon 818 and the artificial heart valve crimped thereon.

[0217] In some embodiments, the distal portion 832 of the balloon 818 may include one or more axial folds or pleats 834 when the balloon 818 is deflated and ready for insertion into the patient's vascular system. In some embodiments, the proximal portion 836 of the balloon 818 may include one or more axial folds or pleats 838 when the balloon is deflated and ready for insertion into the patient's vascular system. The axial pleats 834, 838 can reduce the overall shape of the distal end portion 809 of the delivery device 800 and facilitate the passage of the delivery device 800 through the introducer sheath and the patient's vascular system. Further details regarding folding or wrapping the balloon over the distal end portion of the delivery device are described in U.S. Provisional Patent Application No. 63 / 051,244, filed July 13, 2020, which is incorporated herein by reference.

[0218] In some embodiments, the balloon 318 of the delivery device 300 shown in FIGS. 9-11, 28, and 32A-32B can be folded in a manner similar to the balloon 818 as described above. FIG. 37 is an exemplary cross-sectional view of the balloon 318 of the delivery device 300 wrapped around and folded around the inner shaft 308 in the valve-mounted portion 324 of the delivery device 300. As shown in FIG. 37, the balloon 318 includes a plurality of overlapping pleats or folds 390 when in its contracted configuration and when the prosthetic valve is mounted on the balloon 318 and radially compressed therearound. The balloon 318 can be folded so that the pleats 390 result in a minimized folded balloon diameter (e.g., in its contracted configuration) that can reduce the diameter of the prosthetic valve radially compressed thereon when adhered thereto.

[0219] As described above with reference to Figures 9-11, the distal end portion 309 of the delivery device 300 may include a distal tip portion 328 mounted on the distal end of the outer shaft 304. For the delivery of the prosthetic valve to the target implantation site, the outer shaft 304 and the intermediate shaft (e.g., balloon shaft) 306 may be moved axially relative to each other so that the distal tip portion 328 is positioned over the proximal end portion of the balloon 318 (e.g., the proximal tip portion 333 as shown in Figure 10). As a result, the distal tip portion 328 acts as a proximal shoulder on the proximal side of the valve mounting portion 324 while the distal end portion of the delivery device is advanced to the target implantation site, and can resist the movement of the proximal axially and radially compressed prosthetic valve. For example, in some embodiments, the intermediate shaft 306 can be retracted into the outer shaft 304, or the outer shaft 304 can be pushed across the intermediate shaft 306, thereby moving the proximal end portion of the balloon 318 into the interior of the distal tip portion 328. In some embodiments, the distal tip portion 328 may include internal and / or external expansion notches or grooves that provide flexibility to the distal tip portion 328, allowing it to expand radially outward as it moves across the proximal end portion of the balloon 318, thereby acting as a balloon shoulder and increasing its ability to resist axial movement of the radially compressed prosthetic valve mounted around the balloon 318 in the valve mounting portion 324.

[0220] In some embodiments, the distal tip expansion notches, which are arranged along the inner surface of the distal tip portion, may extend axially along the inner surface (with respect to the central longitudinal axis of the delivery device). However, these axially extending expansion notches may cause problems when the balloon shaft (e.g., the intermediate shaft 306) on which the balloon 318 is mounted is rotated when the distal end portion of the delivery device is rotationally aligned at the target implantation site, as described herein (because the balloon 318 rotates as a result of the rotation of the balloon shaft). For example, during rotation of the balloon or the intermediate shaft, the pleats of the folded balloon 318 (described above with reference to Figures 36 and 37) may become trapped in the axially extending internal expansion notches of the distal tip portion. An example of such axially extending expansion notches can be found in U.S. Patent No. 9,061,119, which is incorporated herein by reference.

[0221] Therefore, it may be desirable to have a distal tip portion that expands radially over the proximal end portion of the balloon 318, while also allowing the balloon 318 to slide more easily within the distal tip portion without the balloon's pleats becoming trapped when the intermediate shaft of the delivery device is rotated.

[0222] Figures 38-41 show embodiments of the distal end portion 309 of a delivery device, in which the outer shaft 304 includes a distal tip portion 900 mounted on the distal end of the outer shaft 304, and the balloon 318 includes a radial pressure portion 334 in a specific configuration (Figures 40 and 41). In some embodiments, the distal tip portion 900 may be the distal tip portion 328 shown in Figures 9 and 11.

[0223] The distal tip portion 900 may be configured as a flexible adapter including a flexible portion 912 and a connecting portion (which may also be called a straight portion) 914. The flexible portion 912 may extend from the distal end of the connecting portion 914 and bend from the distal end of the connecting portion 914 (for example, extending radially outward). The connecting portion 914 may be coupled to the distal end of the outer shaft 304 and mounted around it (Figure 39).

[0224] The flexible portion 912 is tapered and may have an outer diameter that increases distally from the distal end of the connecting portion 914 to the distal end of the flexible portion 912.

[0225] The flexible portion 912 may include a plurality of internal expansion notches or grooves 902 (also referred herein as helical internal grooves) and a plurality of external expansion notches or grooves 904 (also referred herein as helical external grooves) (Figures 38, 39, and 41). As shown in Figures 38 and 39, the internal expansion grooves 902 are helical and curve around the central longitudinal axis 906 from the proximal end 908 of the flexible portion 912 (for example, where the flexible portion 912 extends from the joint portion 914) to the distal end 910 of the distal tip portion 900. The external expansion grooves 904 are also helical and may curve around the central longitudinal axis 906 from the proximal end 908 of the flexible portion 912 to the distal end 910 of the distal tip portion 900.

[0226] In some embodiments, each of the internal expansion grooves 902 can be curved about 75 to 110 degrees, about 80 to 100 degrees, or about 85 to 95 degrees around the central longitudinal axis 906. In some embodiments, each of the external expansion grooves 904 can be curved about 75 to 110 degrees, about 80 to 100 degrees, or about 85 to 95 degrees around the central longitudinal axis 906.

[0227] In some embodiments, the internal expansion grooves 902 are spaced apart from each other, and the external expansion grooves 904 are spaced apart from each other around the circumference of the distal tip portion 900.

[0228] In some embodiments, the internal expansion grooves 902 are offset from the external expansion grooves 904 (for example, circumferentially) such that the location where one external expansion groove 904 presses into the outer surface of the distal tip portion 900 is located between the locations where two adjacent grooves of the internal expansion grooves 902 press into the inner surface of the distal tip portion 900 (Figure 38).

[0229] The internal expansion groove 902 and the external expansion groove 904 are configured to allow the flexure portion 912 to flex radially outward as the distal tip portion 900 is moved across the proximal end portion 333 of the balloon 318 toward the valve mounting portion 324 (Figure 40). Figure 41 shows the distal tip portion 900 positioned across the proximal end portion 333 of the balloon 318 while a radially compressed prosthetic valve 922 (which may be analogous to one of the prosthetic valves described herein) mounted on the valve mounting portion 324 of the delivery device is advanced through the patient's vascular system to the target implantation site.

[0230] The helical shape and orientation of the internal expansion groove 902 may be configured to reduce engagement between the pleats of the balloon 318 (e.g., the pleats or folds 390 shown in Figure 37) and the internal expansion groove 902 while the intermediate (balloon) shaft 306 is rotated (e.g., to achieve commissure alignment at the target implantation site, as described herein), thereby allowing the balloon 318 to slide more easily along the inner surface of the distal tip portion 900 while the balloon 318 is rotating within the distal tip portion 900. For example, the helical shape and orientation of the internal expansion groove 902 can prevent the pleats of the balloon 318 from rushing into the internal expansion groove 902 and becoming entangled inside it as the intermediate shaft 306 and therefore the balloon 318 rotate.

[0231] After the artificial valve is crimped onto the valve mounting portion 324 and the distal tip portion 900 is advanced over the proximal end portion 333 of the balloon 318 (as shown in Figure 41), the fluid contained within the proximal end portion 333 of the balloon 318 is displaced and pushed distally within the balloon 318. As a result, the distal end portion 332 of the balloon 318 may expand excessively radially outward, increasing the crimped outer shape (e.g., diameter) of the artificial valve 922. An increase in the crimped valve outer shape may result in increased resistance when pushing the delivery device within and through the loader and sheath of the delivery assembly.

[0232] Therefore, in order to reduce or prevent an increase in the crimped outer shape of the artificial valve 922, the distal end portion 332 of the balloon 318 may be formed with a radial press portion 334 that is pressed inward toward the central longitudinal axis 320 of the delivery device (Figures 40 and 41). In some embodiments, the radial press portion 334 may be pressed inward toward the outermost radial surface of the distal shoulder portion 326. For example, as shown in Figure 40, the distal end portion 332 of the balloon 318 may extend across the wider opening portion 331 of the distal shoulder portion 326 (which may be formed by, for example, a wing 330), then be pressed radially inward toward the base portion 325 of the distal shoulder portion 326, and then extend radially outward toward the proximal end of the nose cone 322, thereby forming a radial press portion. Figure 40 shows the state of the balloon 318, including the radially pressing portion 334 of the distal end portion 332, before the artificial valve is pressed onto the valve mounting portion 324 and the distal end portion 900 is advanced over the proximal end portion 333 of the balloon 318.

[0233] (As shown in Figure 41) After the artificial valve is crimped onto the valve mounting portion 324 and the distal tip portion 900 is advanced over the proximal end portion 333 of the balloon 318, the fluid contained within the proximal end portion 333 of the balloon 318 is displaced and pushed distally within the balloon 318 to the distal end portion 332 of the balloon 318. The radially pushed distal end portion 332 of the balloon 318 can then expand radially (e.g., partially inflate) to an expanded state 924 shown in Figure 41 (solid line) and Figure 26 (dashed line) as it receives the displaced fluid. The radially pushed portion 334 may be configured (e.g., sizing) to receive the displaced fluid without the distal end portion 332 radially expanding a portion of the balloon 318 within the valve mounting portion 324, thereby preventing an increase in the crimped outer shape of the artificial valve 922.

[0234] Before inflating the balloon 318 and deploying the prosthetic valve 922 to the target implantation site, the distal tip portion 900 may be moved axially away from the prosthetic valve 922 and away from the balloon 318 (either by pulling the outer shaft 304 proximal to the intermediate shaft 306, or by pushing the intermediate shaft 306 distal to the outer shaft 304). The prosthetic valve 922 may then be deployed and radially expanded by inflating the balloon 918.

[0235] When balloon 318 is inflated (for example, when the distal end portion of the delivery device and the prosthetic valve reach the target implantation site such as the natural valve), balloon 318 expands to its expanded state (e.g., unfolds), thereby radially expanding the prosthetic valve to its radially expanded state. As balloon 318 expands and its folds or pleats 390 unfold (Figure 37), the prosthetic valve expands radially and rotates by a predetermined (e.g., known) amount. For example, unfolding the balloon's pleats 390 rotates the prosthetic valve during balloon inflation. Thus, the position of the radially expanded prosthetic valve is rotated by a predetermined amount (e.g., 10°, 20°, 30°, or equivalent) from its position on the delivery device before balloon 318 is inflated. In some embodiments, during the manufacture of the delivery device, the balloon may be wound and / or folded in a consistent and / or standardized manner so that a consistent amount of rotation of the artificial valve occurs during valve deployment (for example, for multiple delivery devices manufactured in the same manner).

[0236] Therefore, it may be desirable to mount (e.g., crimp) the artificial valve on the valve mounting portion of the delivery device in a radially compressed state such that the selected commissure of the artificial valve is offset by a predetermined amount from a marker on the delivery device (e.g., marker 500 in Figure 28, marker 600 in Figures 30-32B, or marker 650 in Figures 33-34B), or based on at least a predetermined amount of rotation. In this way, the circumferential offset between the marker and the selected commissure of the artificial valve can compensate for valve rotation that occurs during balloon inflation and valve deployment. In some embodiments, the predetermined amount of offset may be at least in part based on the amount of rotation resulting from the valve that occurs during balloon wrapping and balloon inflation.

[0237] For example, deploying the prosthetic valve by inflating a balloon after aligning a marker on the delivery device with a guidewire within a selected imaging view (e.g., aligning an asymmetric marker with the guidewire so that the marker is positioned at the rear within the selected imaging view) can rotate the prosthetic valve and implant it into the natural valve with its commissure aligned with that of the natural valve (as described in more detail below). In some embodiments, the marker on the delivery device may be configured to indicate the circumferential location of the selected commissure of the prosthetic valve after valve deployment.

[0238] Figure 42 shows an embodiment of an artificial valve 922 mounted on and around the valve mounting portion 324 of the distal end portion 309 of the delivery device 300 in a radially compressed state, with the selected commissure (indicated by the dashed line in Figure 42) 930 circumferentially offset by a predetermined amount 932 from the marker 600. As discussed above, when the artificial valve 922 is deployed by inflating the balloon, the artificial valve 922 can rotate as it expands radially by a predetermined amount 932 so that the selected commissure at 930 is ultimately aligned circumferentially with the marker 600. As a result, the selected commissure at 930 of the implanted artificial valve can be aligned with the selected commissure of the natural valve.

[0239] In alternative embodiments, the predetermined amount of offset 932 may differ from a predetermined amount of inflation of the prosthetic valve during deployment via balloon inflation. For example, as further described below, the predetermined amount of offset may be determined based on a desired imaging view selected to visualize the delivery device within the heart during the implantation procedure (e.g., based on a known location of the target commissure of the natural valve in the selected imaging view). In some embodiments, the predetermined amount of offset may be determined based on both the selected imaging view and a predetermined amount of rotation of the prosthetic valve during deployment.

[0240] A mounting assembly can be used to mount and crimp an artificial valve onto the valve mounting portion of a delivery device in a predetermined position and / or orientation (e.g., circumferential position and / or orientation) relative to the delivery device (e.g., relative to a radiopaque marker on the distal shoulder or another portion of the distal end of the delivery device). The mounting assembly may include a first component configured to interface with the uncrimped artificial valve (e.g., at least partially radially expanded) and a second component configured to interface with a portion of the distal end portion of the delivery device (e.g., a portion located proximal to and / or adjacent to the valve mounting portion). The first and second components of the mounting assembly may be further configured to interface with different sides of a crimping device. As a result, the mounting assembly can hold the artificial valve in a predetermined orientation and / or position relative to the delivery device in the crimper. After crimping the artificial valve onto the valve mounting portion of the delivery device, the artificial valve may be positioned and / or oriented radially relative to the delivery device. For example, a radially compressed artificial valve may be positioned on a delivery device such that (for example, as shown in Figure 42) a selected commissure of the artificial valve is offset circumferentially by a predetermined amount from a marker (or other desired landmark) on the delivery device.

[0241] Figures 43–52 show various configurations that may be used in a mounting assembly configured to crimp an artificial valve (such as one of the artificial valves described herein) onto a valve mounting portion of a delivery device (e.g., valve mounting portion 324 of a delivery device 300) in a predetermined position and orientation. The artificial valve can be crimped onto the valve mounting portion of the delivery device in various ways. In some embodiments, the artificial valve can be crimped onto the valve mounting portion of the delivery device using a crimping device such as the crimping device 1084 shown in Figures 43 and 44. As further described below, the crimping device 1084 may include a meshing surface on the opposite side of the crimping device 1084 that is configured to receive and mesh with the corresponding meshing surfaces on the first and second components of the mounting assembly.

[0242] Figure 43 shows a rear perspective view (or a view from the proximal side of the crimping device 1084), and Figure 44 shows a front perspective view (or a view from the distal side of the crimping device 1084). The crimping device 1084 may include a base 1086, an actuator in the form of a handle 1088, and a channel 1090 into which an artificial valve and a delivery device are inserted. The crimping device 1084 may include a proximal surface 1092, which includes a proximal opening 1094 leading into the channel 1090. The proximal opening 1094 may be configured for the delivery device to be inserted into the channel 1090 through it.

[0243] In some embodiments, the proximal surface 1092 may include a meshing surface having a meshing structure 1096 in the form of a notch that can be configured to mesh with a positioning device 1072, for example, as shown in Figure 49. For example, the meshing surface may include one or more meshing structures 1096.

[0244] The crimping device 1084 may further include a rotatable body 1098 configured to rotate with the rotation of a handle 1088. The crimping device 1084 may be operated by a plurality of pressing surfaces 1000 configured to surround a channel 1090 and apply compressive force to radially compress an artificial valve (e.g., the artificial valve 922 shown in Figures 51 and 52, as described below) located within the channel 1090. The pressing surfaces 1000 may surround the axis 1002 of the channel 1090. The pressing surfaces 1000 may be configured so that as the rotatable body 1098 is rotated, the body presses against the pressing surfaces 1000, causing them to move toward the center of the channel 1090 and reducing the diameter of the channel 1090. The pressing surfaces 1000 may form an iris structure that allows the pressing surfaces 1000 to move toward the center of the channel 1090 and reduce the diameter of the channel 1090. The artificial valve positioned within the channel 1090 will be compressed within the channel 1090 accordingly, due to the radial compressive force on the pressing surface 1000 against the artificial valve.

[0245] As shown in Figure 44, the crimping device 1084 may include a distal surface 1004 that includes a distal opening 1006 leading into the channel 1090. The distal surface 1004 may include a meshing surface that may have a notch 1008. In some embodiments, the notch 1008 may be configured as a notch, recess, depression, or equivalent within the distal surface 1004. The notch 1008 may be configured (e.g., molded) to receive a matching device for the support body of the artificial valve (e.g., a matching member 1024 shown in Figure 45, as further described below).

[0246] The distal opening 1006 may be configured for a portion of the delivery device to pass through during the crimping operation performed by the crimping device 1084.

[0247] The configuration of the crimping device may be modified in alternative embodiments.

[0248] To crimp the prosthetic valve onto the valve mounting portion of the delivery device, it may be desirable to maintain the valve leaflets (e.g., the valve leaflets 60 of the prosthetic heart valve 50 shown in Figures 2A and 2B) in an open position during the crimping of the prosthetic valve to the delivery device, thereby reducing the possibility of deterioration of the valve leaflets and / or the attachment portion of the valve leaflets to the frame of the prosthetic valve. Therefore, in some embodiments, a support body configured to support and / or maintain one or more valve leaflets of the prosthetic valve in an open position may be used as a first component of a mounting assembly configured to hold the prosthetic valve and position the prosthetic valve within the crimper.

[0249] An exemplary support body 1010 is shown in Figure 45. The support body 1010 may be configured to be inserted into a crimping device such as the crimping device 1084 shown in Figures 43 and 44, and may have a support portion 1012 configured to support one or more valve leaflets in an open position, positioned between one or more valve leaflets of the prosthesis and a delivery device (e.g., delivery device 300). The support body 1010 may comprise the support portion 1012 and a coupling portion 1013 configured to be received within and / or coupled to the crimping device. The support body 1010 may include a first end 1014 and a second end 1016. The support portion 1012 may include an outward-facing support surface 1015 (e.g., a surface for contact with the valve leaflets) configured to receive the prosthesis thereon.

[0250] In some embodiments, as shown in Figure 45, the coupling portion 1013 may have a cylindrical shape with a cylindrical outer surface 1018. The coupling portion 1013 may extend from a first end 1014 to a first (e.g., proximal) surface 1020 which can be positioned perpendicular to a central longitudinal axis extending through the center of the support body 1010 from the first end 1014 to a second end 1016. The first surface 1020 can joint the coupling portion 1013 with the support portion 1012, which includes the support surface 1015. In some embodiments, the first surface 1020 may include a matching element, such as a recess 1022, which can be configured to receive a coupling (e.g., a coupling element) 1070 of the ring body (also referred herein as a matching ring) 1038, as shown in Figures 47 and 48.

[0251] The alignment member 1024 is disposed on the joint portion 1013 and may be configured to rotationally align the support body 1010 with the crimping device 1084. The alignment member 1024 may be positioned circumferentially on the joint portion 1013 in close proximity to the first end 1014 at a position that aligns the support body 1010 circumferentially in a predetermined position and orientation within the crimping device 1084.

[0252] In some embodiments, as shown in Figure 45, the alignment member 1024 may have an axially extending projection that extends axially outward from the first end 1014 to the second end 1016 of the support body 1010. In other embodiments, the alignment member may have other configurations, such as a recess or other alignment feature configured to engage with the corresponding meshing surface of the crimping device 1084 (e.g., the notch 1008 shown in Figure 44).

[0253] For example, the alignment member 1024 may be inserted into a notch 1008 on the distal surface 1004 of the crimping device 1084 to rotatably align the support body 1010 with the crimping device 1084. The alignment member 1024 may be further configured to allow the support body 1010 to slide distally out of the notch 1008 during the operation of the crimping device 1084.

[0254] The support portion 1012 may extend from the first surface 1020 to the second end 1016. The support portion 1012 includes the support surface 1015. The support portion 1012, and therefore the support surface 1015, may have a tapered shape that tapers radially inward in the direction from the first surface 1020 to the second end 1016. For example, the diameter of the support portion 1012 may decrease from the first surface 1020 to the second end 1016. In some embodiments, the support portion 1012 may have a conical shape, as shown in Figure 45. In alternative embodiments, the support portion 1012 may have another shape that is tapered as described above, such as a hexagon or a cone.

[0255] In some embodiments, the support portion 1012 may have a maximum diameter less than the diameter of the cylindrical coupling portion 1013.

[0256] In some embodiments, the connector portion 1026 (Figure 45) can connect the support surface 1015 to the first surface 1020 and may have an annular shape with a relatively constant diameter.

[0257] The support surface 1015 may be configured so that the inner surface of the valve leaflet of the artificial valve contacts and rests on the support surface 1015 when the artificial valve is positioned around the support portion 1012 (as shown in Figure 50). The support surface 1015 may be configured to resist the movement of the valve leaflet to the closed position when the artificial valve is positioned around the support portion 1012 and within the crimping device 1084.

[0258] The tapered shape of the support portion 1012 described above allows the support body 1010 to slide distally away from the crimping device 1084 when the pressing surface 1000 of the crimping device 1084 presses against the support surface 1015. Thus, the tapered shape of the support portion 1012 causes a pressing force applied by the pressing surface 1000 to move proximal along the tapered shape of the support surface 1015, thereby allowing the support body 1010 to move distally away from the crimping device 1084. The support surface 1015 can maintain the valve leaflet in the open position as the pressing surface 1000 presses against the tapered support surface 1015.

[0259] In this way, the support body 1010 may be configured to slide axially away from the artificial valve while the crimping device 1084 is crimping the artificial valve, and as a result thereof. The support body 1010 may be inserted into the channel 1090 of the crimping device 1084 and configured to slide axially away from the channel 1090 when the crimping device 1084 crimps the artificial valve 922, and thus may slide distally in the axial direction (as shown in Figure 52).

[0260] As shown in Figure 45, the support body 1010 may include a central opening 1028 leading to a central channel 1030. The central opening 1028 and the central channel 1030 may be configured for a delivery device to extend through them. The inner surface of the support portion 1012 can define the central channel 1030. The central opening 1028 may be located at the second end 1016, and the central channel 1030 may extend from the second end 1016 to the first end 1014.

[0261] During operation, the artificial valve 922 can slide distally on the support surface 1015 of the support portion 1012 of the support body 1010, with the frame 940 of the artificial valve 922 extending over the support surface 1015 and the inner surface of the valve leaflet 942 of the artificial valve positioned in relation to the support surface 1015 (Figures 50 and 51).

[0262] In order to align the artificial valve 922 in a desired circumferential direction around the support portion 1012 and to separate the artificial valve 922 from the first surface 1020 at a desired interval, a ring body (which may also be called an alignment ring) can be used and positioned on the support body 1010.

[0263] Figures 46 and 47 illustrate perspective views from different sides of a ring body 1038 that may be used, for example, with a support body 1010. The ring body 1038 may be configured to be coupled to the support body 1010 and to extend around the support body 1010. The ring body 1038 may include a first surface (which may be a proximal surface) 1040 (Figure 46), a second surface 1042 (which may be a distal surface) (Figure 47) facing the opposite side of the first surface 1040, and an outer (e.g., circumferential) surface 1044 that faces radially outward and connects the first surface 1040 to the second surface 1042. The ring body 1038 may include an inner surface 1046 that faces radially inward and faces the opposite side of the outer surface 1044, the inner surface 1046 defining a central channel (e.g., an opening or opening) 1048 of the ring body 1038.

[0264] In some embodiments, a matching guide can be positioned on the ring body 1038 (Figure 46). The matching guide may comprise one or more indicators 1050a-c (also referred to as matching markers) configured to indicate a desired circumferential (e.g., rotational) position of a selected element (e.g., commissure) of the prosthetic valve 922 relative to the ring body 1038 (Figures 46, 48, and 50). Each indicator 1050a-c may further indicate a desired circumferential position of a selected element of the prosthetic valve 922 relative to the support body 1010 (when the ring body 1038 is coupled to the support body 1010, for example, as further described below with reference to Figures 48 and 50).

[0265] Each indicator 1050a-c may include markings, grooves, raised elements, or other forms of indicators on one or more of the first surface 1040, second surface 1042, or outer surface 1044 of the ring body 1038. One or more or each of the indicators 1050a-c may include changes in the surface shape of the ring body 1038, such as raised or recessed portions (e.g., grooves). Each of the indicators 1050a-c shown in Figures 46-48 and 50 includes, for example, a recessed portion in the form of a groove on the first surface 1040 that extends to the outer surface 1044. In some embodiments, the indicators 1050a-c may also be printed to vary the color of each indicator 1050a-c so that the indicators are more visible. In some embodiments, the indicators 1050a-c may simply be printed on the ring body 1038 without using changes in surface shape (e.g., without grooves).

[0266] The indicators 1050a to c can be spaced circumferentially apart from each other on the ring body 1038. In some embodiments, the indicators 1050a to c can be spaced equally apart from each other around the circumference of the ring body 1038. The circumferential position of each indicator 1050a to c can correspond to and indicate one desired position of the commissures of the artificial valve when the ring body 1038 is coupled to the support body 1010 and the artificial valve is positioned around the support portion 1012 of the support body 1010 (for example, as shown in Figure 50). Thus, the user can position the ring body 1038 on the support body 1010 and align the commissures 944a to c of the artificial valve 922 with their respective indicators 1050a to c (Figure 50).

[0267] In some embodiments, the ring body 1038 may include one or more arms (also referred to as body portions) 1052, 1054 that extend around and define a central channel 1048, respectively (Figures 46 and 47). Each arm 1052, 1054 may have an arc shape that forms the ring body 1038. Each arm 1052, 1054 may comprise half of the ring body 1038 or, as desired, another amount.

[0268] The first arm 1052 may include a first end portion 1056 (Figure 46) and a second end portion 1058 (Figure 47), the first end portion 1056 being positioned on a pivot 1060 (Figure 46) that connects the first arm 1052 to the second arm 1054. The second end portion 1058 of the first arm 1052 may include a coupling for connecting to the second arm 1054. The second arm 1054 may include a first end portion 1062 (Figure 46) positioned on the pivot 1060 and a second end portion 1064 (Figure 47) positioned on the coupling. The coupling (which may also be called a coupling surface) may include a recess in the second end portion 1058 of the first arm 1052 and a projection in the second end portion 1064 of the second arm 1054. The projections may extend into recesses and be held in place by interference fits or other forms of coupling. Thus, the second end portions 1058, 1064 of the first arm 1052 and the second arm 1054, respectively, may be coupled 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 the arms 1052, 1054, which are pivoted to an open position around the second end portions 1058, 1064 and the pivot 1060. For example, the ring body 1038 may be opened to be removed from the support body 1010 and closed to be held around and coupled to the support body 1010.

[0269] As shown in Figures 46 and 47, a first lever (e.g., a radially extending portion) 1066 may extend radially outward from the first arm 1052, and a second lever (e.g., a radially extending portion) 1068 may extend radially outward from the second arm 1054. The first lever 1066 and the second lever 1068 may each be configured to be pressed to rotate the first arm 1052 or the second arm 1054 around the pivot 1060, thereby moving the ring body 1038 to the open position.

[0270] The ring body 1038 may have an axial width 1071 that can define the distance of the artificial valve from the first surface 1020 of the support body 1010 (Figure 46).

[0271] As shown in Figure 47, the ring body 1038 may include a coupling 1070 extending axially outward from the second surface 1042. In some embodiments, the coupling 1070 may be a projection configured to extend into a recess 1022 of the support body 1010 (Figure 45). In alternative embodiments, the coupling 1070 may be a differently shaped engagement feature configured to engage with a corresponding feature on the support body 1010.

[0272] The coupling 1070 can be positioned circumferentially with respect to the recess 1022 such that the ring body 1038 engages with the support body 1010 in a desired circumferential alignment. In this way, the coupling 1070 and the recess 1022 can rotate the ring body 1038 with respect to the support body 1010 so that the artificial valve is circumferentially aligned with respect to the support body 1010 and the crimping device in a desired orientation.

[0273] During operation, the ring body 1038 can be positioned on and / or around the support body 1010 with indicators 1050a-c positioned to match the support body 1010 in a desired rotation (e.g., circumferential direction) (Figure 48). For example, the coupler 1070 shown in Figure 47 is received in the recess 1022, thereby allowing the ring body 1038 to be matched circumferentially at a desired position relative to the support body 1010. In other embodiments, other matching devices may be used to rotationally match the ring body 1038 to the support body 1010 in a desired rotational match.

[0274] The ring body 1038 can abut against the first surface 1020 of the support body 1010. The ring body 1038 may be configured to abut against the artificial valve 922 when the artificial valve 922 is positioned on the support body 1010. Thus, the artificial valve 922 can be positioned on the support surface 1015 such that the end of the artificial valve 922 abuts against the first surface 1040 of the ring body 1038, defining the position of the artificial valve 922 on the support surface 1015. Therefore, the ring body 1038 may include a spacer configured to define the position of the artificial valve 922 on the support body 1010.

[0275] In some embodiments, the ring body 1038 may be oriented in an open configuration with arms 1052, 1054 open, and then positioned on and around the support body 1010 with arms 1052, 1054 closed to secure the ring body 1038 around the support body 1010. The ring body 1038 may be positioned, for example, on the connector portion 1026 shown in Figure 45.

[0276] Next, the artificial valve 922 can be positioned around the support portion 1012 and the support surface 1015 and in contact with the first surface 1040 of the ring body 1038. The artificial valve 922 can be positioned on the support surface 1015 with the commissures 944a to c aligned circumferentially with the indicators 1050a to c and the end of the artificial valve 922 in contact with the first surface 1040 (Figure 50).

[0277] The use of the ring body 1038 may allow the commutators 944a-c of the artificial valve 922 to be positioned in a desired circumferential direction relative to the ring body 1038 and therefore relative to the support body 1010 (for example, relative to the matching member 1024 of the support body 1010). The matching member 1024 then rotationally aligns the support body 1010 with the crimping device 1084, and thus the commutators 944a-c of the artificial valve 922 can be positioned in a desired rotational orientation within the crimping device 1084.

[0278] As a result, the artificial valve 922 can be crimped onto the delivery device in a predetermined circumferential orientation (for example, with respect to a radiopaque marker on the delivery device, as described herein).

[0279] The support body 1010 and the ring body 1038 may each be part of an assembly or system (e.g., a mounting assembly) used to crimp an artificial valve having one or more valve leaflets to a delivery device. In some embodiments, the assembly or system may include a positioning device 1072 configured to be coupled to a part of the delivery device (e.g., a distal end portion) proximal to the valve mounting portion. Figure 49 illustrates, for example, an embodiment of such a positioning device 1072 positioned proximal to the valve mounting portion 324. The positioning device 1072 includes a body 1074, which includes a first portion 1076 and a second portion 1078 joined at a hinge 1080. The main body 1074 may include a central channel 1082 into which the intermediate shaft 306 (or another shaft portion such as the outer shaft 304) of the delivery device can be positioned, and the second part 1078 rotates around a hinge 1080 to close the central channel 1082 and secure the delivery device (e.g., the intermediate shaft 306) within the central channel 1082.

[0280] The main body 1074 may further include a flange portion 1053 (Figure 43) which includes one or more meshing surfaces (e.g., joint surfaces) in the form of a flange 1051 (Figure 49) configured to engage with a meshing structure 1096 of the proximal surface 1092 of the crimping device 1084.

[0281] The positioning device 1072 can be coupled to the distal end portion 309 of the delivery device and used to suspend the distal end portion 309 of the delivery device in a fixed position within the channel 1090 of the crimping device 1084 (Figures 51 and 52). Thus, the positioning device 1072 can hold the delivery device separated from the pressing surface 1000 of the crimping device 1084, for example, as shown in Figure 51.

[0282] Furthermore, the positioning device 1072 may be axially positioned along the delivery device so that the valve mounting portion 324 is held within a defined axial position within the channel 1090 of the crimping device 1084. In some embodiments, such a feature may further allow the distal shoulder portion 326 of the delivery device to be positioned outside and distal to the channel 1090 of the crimping device 1084 so that the distal shoulder portion 326 is not pressed by the pressing surface 1000 during crimping. The delivery device may further be held in a defined axial position relative to the artificial valve 922 positioned on the support body 1010 (Figure 51).

[0283] An exemplary method of operation of the system disclosed herein may include the following steps. These steps may be modified, omitted, or substituted across embodiments as desired.

[0284] First, the ring body 1038 can be positioned on the support body 1010 in a configuration shown, for example, in Figure 48. The ring body 1038 can be rotationally oriented on the support body 1010 in a defined position, for example, by coupling the coupler 1070 shown in Figure 47 with the recess 1022 shown in Figure 48. Thus, the artificial valve 922 can be positioned on the support surface 1015 with its commissures 944a-c aligned circumferentially with the indicators 1050a-c (as shown in Figure 50). The artificial valve 922 can be brought into contact with the ring body 1038.

[0285] Once the artificial valve 922 is positioned on the support surface 1015 with the desired rotational alignment, the ring body 1038 can then be removed from the support body 1010 before the artificial valve 922 is pressed into the delivery device. For example, levers 1066, 1068 can be pressed to rotate arms 1052, 1054 around the pivot 1060, thereby releasing the ring body 1038.

[0286] When the ring body 1038 is removed, the support body 1010 can be inserted into the crimping device 1084 with the artificial valve 922 positioned around the support portion 1012. Figure 51 illustrates, for example, the artificial valve 922 positioned on and around the support portion 1012, and the support body 1010 inserted into the channel of the crimping device 1084. The distal opening 1006 of the crimping device 1084 may be configured for the support body 1010 to be inserted into the channel 1090. The channel 1090 of the crimping device 1084 may be configured to receive the artificial valve 922, the support body 1010, and the distal end portion 309 of the delivery device.

[0287] When the support body 1010 is inserted into the channel 1090 of the crimping device 1084, the alignment member 1024 can be aligned with the notch portion 1008 of the crimping device 1084 (for example, received inside it). Thus, the rotational orientation of the support body 1010 in the channel 1090 of the crimping device 1084, and therefore the rotational orientation of the artificial valve 922 in the channel 1090 of the crimping device 1084, can be set to a desired position.

[0288] Once the support body 1010 and the artificial valve 922 are inserted into the channel 1090 of the crimping device 1084, the positioning device 1072 (or alternative positioning device, as further described below) may be coupled to the distal end portion 309 of the delivery device and then inserted into the proximal opening 1094 of the crimping device 1084 (Figure 51). The flange 1051 of the positioning device 1072 may engage with the corresponding engagement structure 1096.

[0289] Figure 51 shows the pressing surface 1000 of the crimping device 1084 in a fixed position around the channel 1090, and a cross-sectional view of the support body 1010 inserted into the channel 1090 with the artificial valve 922 positioned around the support portion 1012.

[0290] As shown in Figure 51, 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 may be surrounded by the pressing surface 1000. The connecting portion 1013 of the support body 1010 may be located outside and distal to the pressing surface 1000 and may be retained within the distal opening 1006 of the crimping device 1084. The matching member 1024 may extend proximal within the notch portion 1008 of the crimping device 1084.

[0291] In Figure 51, the valve mounting portion 324 of the delivery device is located within the channel 1090 of the crimping device 1084. The artificial valve 922 is located within the channel 1090 and around the valve mounting portion 324 of the delivery device. The support body 1010 is located within the channel 1090 and between the artificial valve 922 and the delivery device. The support body 1010 supports the valve leaflets of the artificial valve 922 in the open position. The distal end portion 309 of the delivery device extends distally within the internal channel 1090 of the crimping device 1084 and distally within the central channel 1030 of the support body 1010.

[0292] When inserted into the crimping device 1084, the positioning device 1072 may be coupled to the distal end portion 309 of the delivery device proximal to the valve mounting portion 324 and may engage with the meshing structure 1096 of the proximal surface 1092. The positioning device 1072 may be coupled to the distal end portion 309 of the delivery device at a location such that the valve mounting portion 324 is positioned relative to the artificial valve 922 at a desired location within the channel 1090. For example, as shown in Figure 51, the artificial valve 922 may surround the valve mounting portion 324.

[0293] As described above, the rotational alignment of the artificial valve 922 with respect to the distal end portion 309 of the delivery device may be in a desired predetermined orientation and / or position due to the previous use of the ring body 1038.

[0294] When the distal end portion 309 of the delivery device, the support body 1010, and the artificial valve 922 are in the desired position within the channel 1090, the actuator of the crimping device 1084 can be actuated to compress the artificial valve 922. For example, the handle 1088 can be rotated to rotate the rotatable body 1098 and move the pressing surface 1000 radially inward relative to the artificial valve 922 (Figures 43 and 44).

[0295] Figure 52 illustrates, for example, a pressing surface 1000 being moved radially inward to apply a compressive force to the artificial valve 922. The artificial valve 922 is crimped to the delivery device around the valve mounting portion 324 using the pressing surface 1000 of the crimping device 1084. As shown in Figure 52, in its radially compressed state, the artificial valve 922 has an increased length in the axial direction.

[0296] Pressing the artificial valve 922 to the delivery device may involve applying force to the support surface 1015 of the support body 1010 using the pressing surface 1000, thereby causing the support body 1010 to slide axially away from the artificial valve 922 within the channel 1090 (Figure 52).

[0297] For example, as described above, the tapered shape of the support portion 1012 and the support surface 1015 allows 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 releasably connect to the crimping device 1084 and slide axially away from the channel 1090 when the crimping device 1084 crimps the artificial valve 922. In some embodiments, the support body 1010 can be ejected outward from the distal opening 1006, as shown in Figure 52. The elongated shape of the matching member 1024 may allow the matching member 1024 to slide outward from the notch portion 1008.

[0298] In this embodiment, the support body 1010 may not be released but may remain coupled to the crimping device 1084 during crimping. The support body 1010 may slide distally, for example, while a tether or another form of coupling holds the support body 1010 coupled to the crimping device 1084 to prevent the support body 1010 from falling.

[0299] After the artificial valve 922 is crimped to the delivery device, the positioning device 1072 can be disengaged from the interlocking structure 1096 and moved outward from the proximal opening 1094, thereby moving the delivery device outward away from the crimping device 1084. The positioning device 1072 can then be removed from the distal end portion 309 of the delivery device with the artificial valve 922 crimped to it.

[0300] In this way, the use of a mounting assembly including the support body 1010 may allow the valve leaflets of the artificial valve 922 to remain in the open position during crimping. Such a feature may reduce the possibility of deterioration of the artificial valve 922 that may occur during crimping. Furthermore, the tapered shape of the support body 1015 may allow the support body 1010 to slide outward from the crimping equipment via radially inward movement of the pressing surface 1000, so that the support body 1010 automatically moves outward away from the crimped artificial valve 922. The support body 1010 may automatically slide axially outward so that the support surface 1015 is not positioned between the artificial valve 922 and the pressing surface 1000 after crimping. In some embodiments, the system may be configured so that a separate mechanism slides the support body 1010 distally so that the tapered shape is not utilized on the support surface 1015. For example, an arm, gear, or other form of coupling may engage with the support body 1010 to move the support body 1010 away from the artificial valve 922.

[0301] In some embodiments, the mounting assembly may include differently configured positioning devices configured to mesh with one or more meshing structures (e.g., meshing structure 1096 of crimping device 1084) located on one side of the crimping device. Figure 53 shows another embodiment of a positioning device 1100 that can be used in a mounting assembly and coupled to a crimping device, and Figures 54 and 55 show a side view and a perspective view of the positioning device 1100 coupled to the distal end portion 309 of the delivery device 300 proximal to the valve mounting portion 324, respectively.

[0302] As shown in Figure 53, the positioning device 1100 may include a body 1102 comprising a first part 1104 and a second part 1106 pivotally coupled to each other via a hinge 1108. The body 1102 may include a central channel 1110 (Figure 53) 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).

[0303] A second portion 1106 of the main 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 meshing elements configured to mesh with a correspondingly molded meshing mechanism within the side surface (e.g., proximal surface) of the crimping device. In some embodiments, as shown in Figure 53, the meshing elements are configured as circumferentially extending portions 1114. In some embodiments, the extending portions 1114 may be spaced apart from each other around the circumference of the flange portion 1112.

[0304] In some embodiments, the flange portion 1112 may include one or more directional elements 1116 that can indicate the orientation for insertion of the extended portion 1114 into the crimping device.

[0305] As shown in Figures 54 and 55, the positioning device 1100 is located proximal to the proximal end of the balloon 318 and is clamped around the intermediate shaft 306 in an adjacent location.

[0306] Alternative embodiments of mounting assemblies configured to crimp an artificial valve onto a delivery device in a predetermined position and / or orientation relative to the delivery device are described in International Patent Application PCT / US19 / 28831, which is incorporated herein by reference.

[0307] Figure 56 is a flowchart of exemplary method 1200 for crimping an artificial valve to the distal end portion of a delivery device in a radially compressed state, at a predetermined position and orientation relative to the delivery device. In some embodiments, method 1200 may utilize one or more components of the mounting assembly described herein with reference to Figures 43-55.

[0308] Method 1200 begins by positioning an artificial valve (e.g., artificial valve 10 in Figure 1, artificial valve 50 in Figures 2A-2B, or artificial valve 922 in Figure 41) on an implant holder device such that one or more commissures of the artificial valve align with one or more corresponding indicators or alignment markers on an alignment ring (or ring body) coupled to the implant holder device. The implant holder device may be configured to receive an artificial valve that is at least partially radially expanded and to hold the artificial valve in a desired circumferential orientation. In some embodiments, the implant holder device may be a support body 1010 in Figures 45 and 48, and the alignment ring may be a ring body 1038 in Figures 46-48 and 50. For example, in some embodiments, the method in 1200 may include rotatably aligning the artificial valve on the support portion of the support body such that one or more commissures of the artificial valve coincide and align with corresponding indicators on the ring body (e.g., as shown in Figure 50). In an alternative embodiment, the matching ring may be one of the matching rings shown in Figures 65-68.

[0309] 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.

[0310] In 1206, the method includes attaching a positioning device to the delivery device. In some embodiments, attaching the positioning device may include coupling a portion of the positioning device around the shaft of the delivery device, proximal to the valve-mounted portion of the delivery device and the proximal portion of the inflatable balloon of the delivery device. In some embodiments, the positioning device may be coupled to and around an intermediate (e.g., balloon shaft) of the delivery device (e.g., intermediate shaft 306 as shown in Figure 54). The positioning device may be one of the positioning devices described herein (e.g., positioning device 1072 in Figure 49 or positioning device 1100 in Figures 53-55), or another positioning device coupled to the delivery device and a crimping device, configured to hold the delivery device in a desired circumferential orientation relative to the crimping device. For example, the method in 1206 may include coupling the positioning device to the delivery device such that when the positioning device is coupled to the crimping device, a radiopaque marker on the delivery device is held in a desired circumferential orientation within the crimping device.

[0311] Method 1200 proceeds to 1208, which includes locating (e.g., distributing or coupling) the distal end portion of the delivery device and the positioning device within a first (e.g., proximal) side of a crimping device (e.g., crimping device 1084 in Figures 43 and 44 or another crimping device). For example, a flange portion of the positioning device including one or more engagement elements may be coupled to a first side of the crimping device such that one or more engagement elements engage with one or more corresponding engagement elements within the first side of the crimping device. As a result, the distal end portion of the delivery device coupled with the positioning device may be distributed within a portion of the crimping device configured such that the valve mounting portion presses against the artificial valve and crimps the artificial valve. In this way, the positioning device and valve mounting portion of the delivery device may be received within the crimping device in a predetermined circumferential orientation and position.

[0312] In 1210, the method includes positioning the implant holder device within a second (e.g., distal) side of the crimping device. For example, the method in 1210 may include inserting the implant holder device into the second side of the crimping device such that the matching member of the implant holder device is inserted into and / or engages with the corresponding occlusal structure or element of the crimping device. In this way, the implant holder device and the artificial valve disposed on the implant holder device can be received within the crimping device in a predetermined orientation. For example, when both the implant holder device coupled to the artificial valve and the positioning device coupled to the delivery device are coupled to the crimping device, the selected commissure of the artificial valve may be offset by a predetermined amount circumferentially with respect to the central longitudinal axis of the delivery device from a radiopaque marker on the distal end portion of the delivery device (e.g., one of the markers shown in Figures 28, 18A-18B, or 42).

[0313] In 1212, the method includes using a crimping device to crimp the prosthetic valve onto the valve mounting portion of the delivery device in a radially compressed state. In some embodiments, crimping the prosthetic valve in 1212 may include crimping the prosthetic valve onto the valve mounting portion in a radially compressed state around an inflatable balloon. In addition, in some embodiments, crimping the prosthetic valve in 1212 may include crimping the prosthetic valve onto the valve mounting portion of the delivery device in a radially compressed state while maintaining a predetermined amount of offset between a radiopaque marker and a selected commissure of the prosthetic valve (for example, as shown in Figure 42 as described above). As further described below, the predetermined amount of offset may be determined (e.g., pre-selected) based on a desired or selected imaging view used to image the distal end portion of the delivery device during the implantation procedure and to rotationally align the prosthetic valve with the natural anatomical structure (e.g., to achieve commissure alignment). During crimping in 1212, in some embodiments, the implant holder device can be automatically disengaged from the artificial valve and / or crimping device (as described above with reference to, for example, Figures 51 and 52).

[0314] In 1214, the method includes removing the distal end portion of the delivery device from the crimping device with the artificial valve crimped over it. The method in 1214 may further include removing (e.g., discoupling) the positioning device from the delivery device. In this way, the positioning device may be detachably coupled to the delivery device, and the implant holder device may be detachably coupled to the artificial valve as described above. After removal from the crimping device, the delivery device may then be prepared for insertion into the patient's blood vessels and navigation to the patient's heart.

[0315] Figure 57 is a flowchart of exemplary method 1300 for implanting a prosthetic valve in a patient's heart's natural valve, such that one or more selected commissures of the prosthetic valve are aligned (e.g., circumferentially) with one or more corresponding commissures of the natural valve. In some embodiments, method 1300 may be performed using a delivery device configured to deploy a radially compressed prosthetic valve mounted on the distal end portion of the delivery device by inflating a balloon of the delivery device. Exemplary delivery devices 300 are shown in Figures 9-11. The delivery device may include one or more of the components described herein to assist in rotational alignment of the delivery device at the implantation site (e.g., the natural valve) to achieve the commissure alignment described above. In alternative embodiments, method 1300 may be performed using a delivery device configured to deploy a radially compressed valve by axially moving a sheath or capsule covering the radially compressed prosthetic valve relative to the shaft of the delivery device (thus moving the capsule instead of inflating the balloon to deploy the prosthetic valve).

[0316] Method 1300, starting from 1302, includes receiving an artificial valve mounted on the distal end portion of the delivery device in a radially compressed configuration around the inflatable balloon of the delivery device, at a predetermined position and orientation relative to the delivery device, such that the selected commissure of the artificial heart valve is offset by a predetermined amount circumferentially with respect to the central longitudinal axis of the delivery device from a radiopaque marker on the distal end portion of the delivery device. In some embodiments, the predetermined amount is determined based on a selected imaging view, as further described below with reference to Figures 58-68.

[0317] In some embodiments, as described above with reference to Figures 30-34B, the marker may be reflectively asymmetric along an axis parallel to the central longitudinal axis. In some embodiments, the marker may be positioned on the polymer body of the delivery device, such as the proximal shoulder, distal shoulder, or nose cone. In some embodiments, the marker is disposed on and / or embedded in the wide-mouth portion of the distal shoulder of the delivery device, and the distal shoulder is disposed distal to the valve-mounted portion of the delivery device (as shown, for example, in Figures 32A-32B and 42).

[0318] In some embodiments, the method in 1302 may include crimping an artificial heart valve onto the distal end portion of the delivery device using a mounting assembly, as described above with reference to the method in Figure 56.

[0319] In 1304, the method includes advancing the distal end portion of the delivery device toward the natural valve of the patient's heart. In some embodiments, the method in 1304 may also include first inserting the distal end portion of the delivery device into the patient's vascular system with the expansion port of the adapter of the delivery device facing the user (e.g., the user performing the implantation procedure) in order to orient the radiopaque marker entering the patient toward a table on which the patient is positioned (for example, due to the arrangement of the adapter 312 and the rotatable knob 314 toward the marker, as described above with reference to Figures 15-22).

[0320] After advancing the distal end portion of the delivery device to a location close to the natural valve (e.g., within the patient's heart), the method, following 1306, includes visualizing, under fluoroscopy, the position of a radiopaque marker on the distal end portion of the delivery device relative to a guidewire extending through the shaft of the delivery device for a selected imaging view. For example, using medical imaging such as fluoroscopy, as described above with reference to Figures 29, 31A-31B, and 34A-34B, the radiopaque marker may be visualized together with the guidewire and additional components (e.g., the valve frame of an artificial valve mounted on the delivery device). The position of the radiopaque marker relative to the guidewire can be seen in a selected imaging view (e.g., the marker may appear radially offset from the guidewire when it is not directly in front of or behind the guidewire in the imaging view, as shown in the embodiment of Figure 29). Since fluoroscopy does not naturally provide a viewpoint for distinguishing what is in front of it in contrast to what is behind it in a selected imaging view, this viewpoint may be provided by visualizing the position of an asymmetric marker relative to the guidewire, as further described below.

[0321] As further described below with reference to Figures 61-64, the user can select from several possible imaging views for imaging the distal end portion of the delivery device to the heart and natural valve. For each imaging view, the location of the target commissure of the natural valve aligned with the selected commissure of the (post-implant) artificial heart valve can be determined within the selected imaging view. An exemplary fluoroscopic image 1400 of a natural (e.g., aortic) valve 1402 viewed using a more standard three-lobe imaging view is shown in Figure 58. As shown in Figure 58, the natural aortic valve 1402 includes three leaflets: a non-coronary leaflet 1404, a right coronary leaflet 1406, and a left coronary leaflet 1408. In the three-lobe view, the non-coronary leaflet 1404 and the left coronary leaflet 1408 are positioned opposite each other in the view, each overlapping with a portion of the right coronary leaflet 1406. Therefore, the commissure between the non-coronary lobe 1404 and the left coronary lobe 1408 is known to be located posterior to image 1400.

[0322] In 1308, the method includes rotating the shaft of the delivery device, which rotates the artificial heart valve and the marker until the marker is centered along the guidewire and oriented in a predetermined orientation within the selected imaging view, before crossing the natural valve. The method in 1308 may be performed while imaging the heart and visualizing the selected imaging view.

[0323] In some embodiments, a predetermined orientation within the selected imaging view is directly behind the imaging view (e.g., away from the viewer). In alternative embodiments, a predetermined orientation within the selected imaging view is directly in front of the imaging view (e.g., towards the viewer). Thus, in some embodiments, the radiopaque marker may 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 markers positioned in front of and behind the selected imaging view (compared to a symmetric marker that would appear the same to the viewer within the imaging view regardless of whether the marker is behind or in front of the guidewire).

[0324] For example, in some embodiments, as shown in Figure 59, the asymmetric marker 600 may be configured as an alphabet letter, appearing forward when the marker is centered along the guidewire 606 and positioned directly behind the imaging view (e.g., behind the guidewire, as shown in Figure 59) (e.g., a forward-readable "C" as shown in Figure 31A), and appearing backward when the marker is centered along the guidewire and positioned directly in front of the imaging view (e.g., a backward-facing "C" as shown in Figure 31B). Thus, the method in 1308 may include rotating the shaft of the delivery device, which rotates the artificial heart valve and the marker, until the marker appears centered along the guidewire in its forward orientation within a selected imaging view, thereby positioning the marker directly behind the imaging view.

[0325] In alternative embodiments, the asymmetric marker appears forward 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 appears backward when the marker is centered along the guidewire and positioned directly behind the imaging view. Thus, in these embodiments, the method in 1308 may include rotating the shaft of the delivery device, which rotates the artificial heart valve and the marker, until the marker appears centered along the guidewire in its backward orientation within the selected imaging view, thereby positioning the marker directly behind the imaging view.

[0326] In yet another embodiment, the method in 1308 may include rotating the shaft of the delivery device, which rotates the artificial heart valve and the marker until the marker appears centered in its predetermined orientation (forward or backward) along the guidewire within a selected imaging view, thereby positioning the marker directly in front of the imaging view. In this way, a predetermined offset between the selected commissure of the artificial heart valve and the marker on the delivery device may be determined based on both the selected imaging view and the target orientation of the marker within the selected imaging view (directly forward or directly backward).

[0327] By rotating the distal end of the delivery device before crossing the natural valve, blood flow through the natural valve (which may be narrowed) may not be obstructed by the delivery device. In addition, in some embodiments, if a compressed prosthetic valve is rotated within (e.g., across) the natural valve (which may have calcified leaflets), it may generate embolisms that can lead to stroke or other medical complications by knocking calcium fragments off the leaflets. Therefore, by rotating the distal end of the delivery device and the radially compressed prosthetic valve outside the natural valve (e.g., in the ascending aorta), embolisms and other complications can be reduced or avoided. Furthermore, the user can spend more time rotating the device because it is not positioned to obstruct blood flow through the natural valve.

[0328] After achieving the desired rotational positioning of the radiopaque marker relative to the guidewire in 1308, the method continues in 1310, which includes advancing the distal end portion of a delivery device containing a radially compressed prosthetic heart valve across and into the natural valve, inflating a balloon to radially expand the prosthetic heart valve and implant it into the natural valve so that a selected commissure of the prosthetic heart valve aligns with the target commissure of the natural valve.

[0329] In some embodiments, as the prosthetic valve expands radially during inflation, the prosthetic valve rotates by an amount equal to a predetermined offset between the marker and the selected commissure as the prosthetic valve is radially compressed around the balloon. For example, as shown in the illustrative schematic diagram of Figure 60, the target commissure 1450 of the natural valve 1452 is known to be directly behind the selected imaging view used for rotational positioning at the implantation site, and when the marker 600 is aligned directly behind the selected imaging view, the prosthetic valve 922 rotates by an amount equal to a predetermined offset between the marker and the selected commissure 930 of the prosthetic valve 922 as the prosthetic valve is radially compressed around the balloon (as indicated by arrow 1454 in Figure 60), thereby allowing the prosthetic valve 922 to be implanted with the selected commissure 930 circumferentially aligned with the target commissure 1450 of the natural valve 1452.

[0330] In an alternative embodiment, as the prosthetic valve expands radially during inflation, the prosthetic valve rotates by an amount greater than or less than the amount of offset between the marker and the selected commissure when the prosthetic valve is radially compressed around the balloon. However, this amount of offset can be predetermined based on existing knowledge of the selected imaging view and the position of the target commissure of the natural valve within the selected imaging view. Thus, 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 amount of offset between the marker and the selected commissure of the radially compressed prosthetic valve can be adjusted for different imaging views so that, as the balloon inflates, the prosthetic valve rotates and the commissure is implanted in alignment with the commissure of the natural valve.

[0331] Examples of this rotational alignment and adjustment of the circumferential offset between the marker on the delivery device and the selected commissure of the radially compressed artificial heart valve for different imaging views are described below with reference to Figures 61-68.

[0332] As described above, a schematic diagram of a first embodiment of a more standard three-lobe imaging view 1500 of a natural valve 1510, which can be used to visualize the delivery device within the patient's heart and to rotationally align the prosthetic valve during the transplantation procedure, is shown in Figure 61. In the three-lobe view 1500, the non-coronary lobes 1502 and left coronary lobe 1504 of the natural valve (e.g., aortic valve) 1510 are positioned opposite each other in the view, and each is overlapped by a different portion of the right coronary lobe 1506 with all three lobes aligned along the transverse axis 1508. Thus, for the three-lobe imaging view 1500, as shown in the cross-sectional view of the natural valve 1510 in Figure 62, the selected commissure 1512 of the natural valve 1510, positioned between the non-coronary lobe 1502 and the left coronary lobe 1504, is positioned directly posterior 1514 to the three-lobe imaging view 1500. Figure 62 also shows the location of the right coronary artery lobe 1506, directly anterior to the imaging view 1516.

[0333] In contrast, Figure 63 shows a schematic diagram of a second embodiment of a different right / left lobe overlapping view 1550 of the natural valve 1510, which may be used to visualize the delivery device within the patient's heart and to rotationally align the prosthetic valve during the implantation procedure, as described above. In the right / left lobe overlapping view 1550, the left coronary artery lobe 1504 and the right coronary artery lobe 1506 overlap each other, and the non-coronary artery lobe 1502 is offset from the left coronary artery lobe 1504 and the right coronary artery lobe 1506. For the right / left lobe overlapping view 1550, as shown in the cross-sectional view of the natural valve 1510 in Figure 64, the selected commissure 1512 is circumferentially offset from directly posterior 1514 of the imaging view.

[0334] In alternative embodiments, it should be noted that different commissures of the natural valve (other than the commissure located between the non-coronary valve lobe and the left coronary valve lobe) may be selected commissures, based at least partially on a predetermined offset between the marker and the selected commissure of the prosthetic valve.

[0335] Therefore, for two different imaging views shown in Figures 61 and 63, the circumferential offset between the radiopaque marker on the delivery device and the selected commissure of the radially compressed prosthetic valve may be different predetermined offset values. In some embodiments, the implantation procedure may proceed in the same manner for different imaging views (e.g., as shown in Figures 59 and 60) by rotating the radiopaque marker on the delivery device with a guidewire so that the marker is positioned directly behind the imaging view (e.g., the method in 1304, 1306, 1308, and 1310 may proceed as described above using different selected imaging views). However, the loading of the prosthetic valve onto the delivery device may be adjusted so that different amounts of circumferential offset between the marker and the selected commissure of the prosthetic valve are used for different procedures using different imaging views, and the determined amount of circumferential offset for the selected imaging view causes the prosthetic valve to be implanted into the natural valve with the commissure aligned with the commissure of the natural valve.

[0336] It should be noted that the two imaging views shown in Figures 61 and 63 are examples of two different imaging views that may be used during valve implantation procedures to rotationally align an artificial valve with a natural valve. However, additional different imaging views are possible and can be used in conjunction with the systems and methods described herein to position the target commissure of the natural valve at a different location directly behind (or in front of) the selected imaging view. In this way, the user can select from a plurality of possible imaging views and determine (e.g., pre-determine) the circumferential location of the selected (or target) commissure (e.g., commissure 1512 shown in Figures 62 and 64) relative to the behind (or in front of) the selected imaging view.

[0337] In some embodiments, different indicators on a matching ring (e.g., a ring body similar to the ring body 1038 shown in Figures 46-48) or an implant holder device (e.g., the support body 1010 in Figures 45 and 48) indicating the alignment location of one or more commissures of an artificial valve can be used for different selected imaging views for valve implantation procedures.

[0338] Figures 65–68 show exemplary embodiments of different alignment rings that can be used in a mounting assembly and are configured to rotationally align an artificial valve on an implant holder device, thereby compressing the artificial valve onto the valve mounting portion of the delivery device in a predetermined circumferential orientation relative to a radiopaque marker on the distal end portion of the delivery device. For example, the alignment ring may be configured such that the artificial valve is radially compressed on the delivery device with a selected commissure circumferentially offset from the radiopaque marker on the distal end portion of the delivery device by a predetermined amount determined (e.g., selected) based on a selected imaging view for use during the implantation procedure. In some embodiments, as shown in Figures 65 and 66, different alignment rings may be similar in overall shape and function but have different arrangements of indicators or markers that are specific to the selected imaging view intended for use. For example, different matching rings having specific arrangements of indicators or markers may be configured to align the prosthetic valve on the implant holder device in such a way that, as described above, when the prosthetic valve is deployed from the delivery device with the radiopaque marker aligned with the guidewire, the selected commissure of the prosthetic valve is offset from the radiopaque marker on the delivery device by an appropriate amount to align with the natural valve.

[0339] Figure 65 shows one embodiment of a matching ring 1600 that can be configured to rotate-align an artificial valve with a delivery device for implantation using a first imaging view, such as a three-lobe imaging view (e.g., the three-lobe imaging view 1500 in Figure 61), for the purpose of rotationally aligning and implanting an artificial valve with a delivery device in a natural valve. The matching ring 1600 may be configured to allow the artificial valve to be mounted on the delivery device with a selected commissure of the artificial valve circumferentially offset by a first predetermined amount from a radiopaque marker on the delivery device, the first predetermined amount allowing the artificial valve to be implanted with its commissure aligned with the commissure of the natural valve after deployment of the artificial valve using a delivery device with the radiopaque marker aligned with the guidewire in its predetermined orientation (e.g., indicating that the marker is positioned directly behind the imaging view).

[0340] The alignment ring 1600 may be configured (e.g., structured) in the same way as or identical to the ring body 1038 in Figures 46 and 47. For example, the alignment ring 1600 may include one or more indicators (e.g., alignment indicators or markers) 1610a-c disposed on one or more surfaces of the body 1602 of the alignment ring 1600. As described above with reference to Figures 46 and 47, the indicators 1610a-c may be indentations (e.g., grooves) or etchings into 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.

[0341] As shown in Figure 65, the alignment ring 1600 includes three indicators 1610a-c spaced apart from each other 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 indicate the desired orientation of the prosthetic valve commissure when the prosthetic valve is mounted around the implant holder device (e.g., the support body 1010 shown in Figures 45 and 48) when the alignment ring is coupled to the implant holder device (e.g., as shown in Figure 48). As shown in Figure 65, the first indicator 1610a may be spaced a first arc length 1606 from the first lever (e.g., radially extending portion) 1604.

[0342] In some embodiments, the matching ring 1600 may include additional markings or indicators to indicate its intended use for matching the prosthetic valve implanted in the implantation procedure using a three-lobe imaging view. For example, as shown in Figure 65, the matching ring includes a first mark 1608 ("View A") indicating a selected imaging view for the implantation procedure. In some embodiments, the selected imaging view (View A) may be the three-lobe imaging view described above. In alternative embodiments, the first mark 1608 may be a color coding, a symbol, a numerical code, or an equivalent.

[0343] Figure 66 shows another embodiment of the alignment ring 1700 which may be configured to rotatably align the prosthetic valve with respect to a delivery device for implantation using a second imaging view, such as a right / left lobe imaging view (e.g., the right / left lobe imaging view 1550 in Figure 63), for the purpose of rotatably aligning and implanting the prosthetic valve using a delivery device in a natural valve. The alignment ring 1700 may be configured to allow the loading of the prosthetic valve onto the delivery device with the selected commissure of the prosthetic valve circumferentially offset from the radiopaque marker on the delivery device by a second predetermined amount, the second predetermined amount, after deployment of the prosthetic valve using a delivery device with the radiopaque marker aligned with the guidewire in its predetermined orientation, the prosthetic valve being implanted with the commissure aligned with the commissure of the natural valve (e.g., indicating that the marker is positioned directly behind the imaging view). The second predetermined amount may differ from the first predetermined amount described above with reference to the alignment ring 1600.

[0344] The alignment ring 1700 may be configured (e.g., structured) in the same way as or identical to the ring body 1038 in Figures 46 and 47. For example, similar to the alignment ring 1600, the alignment ring 1700 may include one or more indicators 1710a to c disposed on one or more surfaces of the body 1702 of the alignment ring 1700.

[0345] As shown in Figure 66, the alignment ring 1700 includes three indicators 1710a-c spaced apart from each other 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 indicate the desired orientation of the prosthetic valve commissus when the prosthetic valve is mounted around the implant holder device (e.g., the support body 1010 shown in Figures 45 and 48) when the alignment ring is coupled to the implant holder device (e.g., as shown in Figure 48). As shown in Figure 66, the first indicator 1710a may be spaced a second arc length 1706 away from the first lever (e.g., radially extending portion) 1704.

[0346] In some embodiments, the matching ring 1700 may include additional markings or indicators to indicate its intended use for matching the prosthetic valve implanted in the implantation procedure using a three-lobe imaging view. For example, as shown in Figure 66, the matching ring includes a first mark 1708 ("View B") indicating the selected imaging view for the implantation procedure. In some embodiments, the selected imaging view (View B) may be a right / left lobe overlapping view, as described above. In alternative embodiments, the first mark 1708 may be a color coding, symbol, numerical code, or equivalent.

[0347] Figures 65 and 66 show two possible embodiments of individual alignment rings configured for use with differently selected imaging views for valve transplantation procedures, as described herein. However, additional alignment rings are also possible, configured similarly to those shown in Figures 65 and 66, but having different orientations of indicators (comissure markers) for differently selected imaging views. Thus, in some embodiments, the user can select from a number of different alignment rings specific to the selected imaging view for the transplantation procedure.

[0348] Figure 67 shows another embodiment of the matching ring 1800. The matching ring 1800 may be similar to other matching rings (or ring bodies) described herein, but includes multiple sets of indicators (e.g., matching markers) for use in two or more transplant procedures utilizing differently selected imaging views. For example, the matching ring 1800 may be configured for intended use with two different fluoroscopic imaging views. In the embodiment of Figure 67, the matching ring 1800 includes a first set 1802 and a second set 1804 of indicators that are circumferentially offset from each other. In one embodiment, the first set 1802 of indicators can be used in transplant procedures utilizing a three-lobe imaging view, and the second set 1804 of indicators can be used in different transplant procedures utilizing a right / left lobe overlapping view.

[0349] In some embodiments, the first set of indicators 1802 may have a different color from the second set of indicators 1804. In this way, the indicators of different colors may correspond to different imaging views.

[0350] In other embodiments, the first set of indicators 1802 may have different markings (e.g., line-to-dot) from the second set of indicators 1804. In yet another embodiment, the first set of indicators 1802 may be arranged on a first side (or surface) of the alignment ring 1800, while the second set of indicators 1804 may be arranged on a second opposite side (or surface) of the alignment ring 1800.

[0351] Figure 68 shows another embodiment of the alignment ring 1900. The alignment ring 1900 may be similar to other alignment rings (or ring bodies) described herein, but includes one or more sets of indicators 1902, each set of indicators including a plurality of graduated indicators (or markings). For example, each set of indicators 1902 may include a first (e.g., standard or base) indicator 1904, a second indicator 1906 offset circumferentially by a first amount (e.g., 10°) from the first indicator 1904, a third indicator 1908 offset circumferentially by a second amount (e.g., 20°) from the first indicator 1904, and a fourth indicator 1910 offset circumferentially by a third amount (e.g., 30°) from the first indicator 1904. In alternative embodiments, the set of indicators 1902 may include more or fewer graduated markings than those shown in Figure 68.

[0352] Graduated matching rings, such as the matching ring 1900, which have multiple graduated markings for one or more commissure locations, may be useful for patients with atypical anatomical structures or for user-customized imaging views. For example, a user (e.g., a physician) may identify from a pre-procedure CT (or other imaging modality) that a patient has a natural valve with commissures and / or coronary arteries in abnormal (e.g., non-standard) locations. Thus, more customizable matching rings, such as the graduated matching ring 1900, may allow a physician to offset the prosthetic valve commissure from a more standard location. For example, the offset of the natural valve commissure from the expected location may be measured on a pre-procedure CT, and the physician may then ask the user to offset the prosthetic valve by 20° from the standard on the matching ring and implant holder device (e.g., using a third indicator 1908 shown in Figure 68).

[0353] In this way, a method, assembly, and / or apparatus for implanting an artificial heart valve in a natural valve is provided, such that the commissure of the artificial heart valve is circumferentially aligned with the commissure of the natural valve. As a result, access to the coronary arteries can be increased.

[0354] In some embodiments of the delivery device and / or method described herein, the distal end portion of the delivery device may include a valve mounting portion configured to receive a radially compressed artificial valve thereon, and a polymer body disposed adjacent to the valve mounting portion. In some embodiments, the polymer body may include radiopaque markers configured to indicate the location of the commissures of the artificial valve after the artificial valve has been radially expanded by inflating the balloon of the delivery device. In some embodiments, the polymer body may include radiopaque markers configured to align with a guidewire extending through the center of the delivery device in a predetermined orientation so that the artificial valve is implanted with the commissures aligned with the commissures of the natural valve.

[0355] In some embodiments, the method, assembly, and / or apparatus may additionally, or alternatively, include a method for arranging and radially compressing an artificial valve on the valve mounting portion of a delivery device such that selected commissures of the artificial valve are in a predetermined position and orientation relative to the radiopaque markers of the delivery device.

[0356] In some embodiments, the method, assembly, and / or apparatus may additionally, or alternatively, include a method for forming and / or folding a balloon of the delivery device, which results in a certain amount of rotation of the prosthetic valve during deployment of the prosthetic valve to its radially expanded state. As a result, after the inflation of the balloon and the radial expansion of the prosthetic valve, selected commissures of the prosthetic valve may be aligned circumferentially with the radiopaque marker of the delivery device and / or the target commissure of the natural valve.

[0357] In some embodiments, the method, assembly, and / or apparatus may additionally, or alternatively, include a delivery device configured to rotate the balloon of the delivery device together with a crimped (e.g., radially compressed) artificial valve without adversely affecting the flexural capacity of the distal end portion of the delivery device and / or the inflation of the balloon.

[0358] In some embodiments, the methods, assemblies, and / or apparatus may additionally, or alternatively, include a delivery device having a radiopaque marker, the radiopaque marker being visible under fluoroscopy and having an asymmetric shape that allows the user to determine whether the marker is positioned in front of or behind the fluoroscopic image (for example, when viewed by the user).

[0359] In some embodiments, the method, assembly, and / or apparatus may, in addition or alternatively, include a method for rotating the distal end portion of the delivery device, including a radiopaque marker and a radially compressed prosthetic valve, during the implantation procedure to rotationally align the marker with a predetermined location in a selected imaging view, the target commissure of the natural valve to which the prosthetic valve is intended to be implanted, a guidewire extending through the delivery device, and / or a radiopaque marker and a radially compressed prosthetic valve. In some embodiments, the method for rotation may occur during selected portions of the implantation procedure to reduce the likelihood of clinical complications occurring.

[0360] In some embodiments, the method, assembly, and / or apparatus may additionally, or alternatively, include a method for deploying an artificial valve into the natural valve using the delivery device, such that a selected fluoroscopic image acquired during the implantation procedure is used to rotationally align the radiopaque marker of the delivery device with a selected commissure of the natural valve, and the selected commissure of the artificial valve is circumferentially aligned with the selected commissure of the natural valve.

[0361] Each of the features described above for a method, assembly, and / or apparatus may be combined with one or more of the other features described above for a method, assembly, and / or apparatus.

[0362] In this way, the prosthetic valve can be deployed more easily at the implantation site, such that the radially expanded commissures of the prosthetic valve are aligned with the commissures of the natural valve, thereby avoiding the placement of the prosthetic valve commissures in obstructing and / or positioning them in front of the coronary arteries. As a result, blood flow into and access to the coronary arteries may be increased.

[0363] In some embodiments, the balloon cover may be configured to enclose (e.g., wrap) the distal end portion of the delivery device, including the inflatable balloon mounted thereon (and folded) (e.g., a portion of the distal end portion 309 of the delivery device 300 shown in Figures 10 and 40-42), during pre-delivery and / or storage, and / or during the degassing process.

[0364] For example, before crimping an artificial valve onto the balloon of a delivery device, the user typically performs a periodic "degassing" process, which involves pushing inflation fluid into the balloon and then withdrawing the fluid from the balloon using a syringe or similar device fluidically connected to the handle of the delivery device. The degassing process may be more effective when the balloon is at least partially inflated. However, inflation of the balloon outside the balloon cover may result in the balloon expanding, which may prevent or stop the balloon from returning to its folded state (e.g., as shown in Figure 37) when the inflation fluid is removed from the balloon. The balloon cover may be configured to prevent the balloon from fully expanding and / or to assist the balloon in returning to its fully folded state after the inflation fluid has been removed from the balloon.

[0365] Conventional balloon covers may comprise two shell portions or halves disposed around the distal end portion of a delivery device (e.g., the distal end portion 309 of a delivery device 300 on which balloon 318 is mounted, as shown in Figures 9-11 and 40) and configured to interlock together, including the balloon. In some embodiments, a removable sleeve can be slid across and around the assembled balloon cover to hold (and connect) the two shell portions of the balloon cover together. When the user is ready to mount or crimp an artificial valve onto the delivery device around the balloon (e.g., as shown in Figure 41), the user can grasp the delivery device and pull to remove the sleeve from the delivery device.

[0366] However, when the delivery device includes a positioning device coupled to the distal end portion of the delivery device (for example, a positioning device 1100 coupled to the distal end portion 309 of the delivery device 300, as shown in Figures 54 and 55, or a positioning device 1072 coupled to the distal end portion of the delivery device, as shown in Figure 49), the user may grasp the positioning device while removing the sleeve from the balloon cover. For example, the user may grasp the positioning device with one hand and then detach it from the balloon cover and from the distal end of the delivery device with the other hand to slide the sleeve. This may result in movement of the positioning device relative to the delivery device (and the radiopaque marker on the distal end portion of the delivery device as described herein). As a result, the prosthetic valve may then be mounted on the balloon in an improper circumferential orientation relative to the marker, which may result in a mismatch of the commissure or commissure of the prosthetic valve with the natural valve at the implantation site (for example, during the implantation procedure, as described above with reference to Figure 57).

[0367] To address such problems, a balloon cover for a balloon mounted on and around the distal end portion of a delivery device may comprise first and second shell members, each having a narrower first portion configured to receive (and enclose) the distal end portion of the delivery device including the balloon, and a wider second portion configured to receive (and at least partially enclose) a positioning device. In this way, the second portion surrounds the positioning device, preventing the 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.

[0368] Figures 69-76B and 108-114 show embodiments of a balloon cover configured to cover a portion of the distal end portion of a delivery device (e.g., the distal end portion 309 of a delivery device 300, as shown in Figures 69, 72-76B, and 108-114), including an inflatable balloon mounted thereon (e.g., balloon 318) and a positioning device (e.g., a positioning device 1100, as shown in Figures 69, 72-76B, and 108-114) coupled to the distal end portion of the delivery device proximal to the valve mounting portion of the delivery device.

[0369] Figures 69–75C illustrate exemplary embodiments of a balloon cover (or balloon cover assembly) 2000, comprising a first cover portion 2001 configured to cover at least a portion of the distal end of a delivery device including a balloon, and a second cover portion 2003 (cover portions 2001 and 2003 shown in Figures 72 and 73) configured to cover a positioning device. The balloon cover 2000 may comprise a first shell member 2002 and a second shell member 2004 configured to interlock with each other and to be removably coupled to each other. For example, the first shell member 2002 and the second shell member 2004 may comprise two halves of the balloon cover 2000 and / or the outer shell 2006 that forms it (Figure 69).

[0370] The outer shell 2006 and balloon cover 2000 are shown in an exploded configuration in the exploded view of Figure 69 and in an assembled configuration in various figures 72-75C. Figure 70 shows the first shell member 2002 disassembled from the rest of the balloon cover 2000. However, in some embodiments, the first shell member 2002 and the second shell member 2004 may be identically constructed (e.g., identically formed), so the first shell member 2002 shown in Figure 70 may alternatively be the second shell member 2004. In addition, Figures 71A-71C show detailed views of the interlocking joint surface 2008 between them (Figure 71C) and the associated interlocking joint surface features or members of the first shell member 2002 and the second shell member 2004 (Figures 71A-71C).

[0371] Each of the first shell member 2002 and the second shell member 2004 includes a first portion (e.g., first shell portion) 2010 and a second portion (e.g., second shell portion) 2012. In some embodiments, the first portion 2010 and the second portion 2012 of one of the first shell member 2002 and the second shell member 2004 may be continuous with respect to each other (e.g., formed as a single part). In some embodiments, the second portion 2012 may have a second width 2018 that is greater than the first width 2016 of the first portion 2010 (Figure 70), and the width is defined radially with respect to the central longitudinal axis 2014 of the balloon cover 2000 (which may be coaxial with the central longitudinal axis of the delivery device when assembled and joined around the delivery device). In some embodiments, the first width 2016 and the second width 2018 may be diameters.

[0372] When the first shell member 2002 and the second shell member 2004 are assembled together (for example, by interlocking), the first shell member 2002 and the first portion 2010 of the second shell member 2004 can form a first cover portion 2001 and define an elongated cavity 2020 (which may be referred to as a lumen in some embodiments). The cavity 2020 may be configured to receive at least a portion (for example, a majority in some embodiments) of the distal end portion of the delivery device and the balloon mounted on the distal end portion of the delivery device (for example, the balloon 318 on the distal end portion 309, as shown in Figures 69 and 72-75C).

[0373] For example, the first portion 2010 of the first shell member 2002 (and similarly the second shell member 2004) comprises an outer surface 2022 (Figures 69 and 70) and an inner surface 2024 (Figure 70). The inner surface 2024 may be an interlocking surface configured to interlock or engage (e.g., face-to-face contact) with each inner surface of the first portion 2010 of the other (e.g., second) shell member forming the balloon cover 2000. In some embodiments, the inner surface 2024 may be planar.

[0374] The first portion 2010 may further include a pressing portion 2026 that is pressed inward (towards the outer surface 2022) into the inner surface 2024. Together, the pressing portions 2026 of the first shell member 2002 and the second shell member 2004 can form a cavity 2020. Thus, each pressing portion 2026 of the first shell member 2002 and the second shell member 2004 can define a cavity portion 2021 that is half of the cavity 2020 (Figure 70).

[0375] Each press portion 2026 may be molded to receive a portion of the distal end portion 309 of the delivery device. For example, each press portion 2026 may include a distal section 2028, a proximal section 2030, and an intermediate section 2032, which is positioned between the distal section 2028 and the proximal section 2030 (Figure 70).

[0376] In some embodiments, the distal section 2028 may be molded (e.g., configured) to receive a balloon (e.g., balloon 318) and a portion of the delivery device over which the balloon overlaps. For example, in the embodiments shown in Figures 69-75C, the distal section 2028 may be molded to receive a portion of the nose cone 322 and the distal end portion 332 of balloon 318 overlapping the distal shoulder portion 326 of the delivery device 300.

[0377] In some embodiments, the intermediate section 2032 may be molded (e.g., configured) to receive the intermediate portion 335 of the balloon and a portion of the delivery device 300 (e.g., the valve mounting portion 324) that overlaps with the intermediate portion 335.

[0378] In some embodiments, the proximal section 2030 may be molded (e.g., configured) to receive at least the distal end portion of the proximal end portion 333 of the balloon 318. In some embodiments, the more proximal portion of the proximal end portion 333 of the balloon 318 may extend into a second portion 2012 of the first shell member 2002 or the second shell member 2004 (Figures 70 and 72). In other embodiments, the proximal section 2030 may be molded to receive the entire proximal end portion 333 of the balloon 318.

[0379] In this way, the shape or contour of the pressing portion 2026 can vary along the first length 2034 of the first portion 2010, the first length 2034 extending axially with respect to the central longitudinal axis 2014 (Figure 70). For example, as shown in Figure 70, the intermediate section 2032 is narrower than each of the distal section 2028 and the proximal section 2030. In some embodiments, the width of the intermediate section 2032 is constant along most of the length of the intermediate section 2032.

[0380] In other embodiments, each pressing portion 2026 may include a distal section 2028 and a proximal section similar to the intermediate section 2032, which may extend from the distal section 2028 to a second portion 2012. In such embodiments, the proximal section may be configured to receive the intermediate portion 335 of the balloon and a portion of the delivery device 300 (e.g., the valve mounting portion 324) that overlaps with the intermediate portion 335. In some embodiments, the proximal section may be further configured to receive the proximal end portion 333 of the balloon 318, which, when positioned within the balloon cover 2000, may not have a diameter portion wider than the intermediate portion 335. Such exemplary embodiments are shown in Figures 108–114, as further described below.

[0381] In some embodiments, the first length 2034 of the first portion 2010 may be longer than the second length 2036 of the second portion 2012.

[0382] In other embodiments, the second length 2036 of the second portion 2012 may be the same as or longer than the first length 2034 of the first portion 2010.

[0383] In some embodiments, the second length 2036 of the second portion 2012 may be selected based on the length and / or size of the positioning device (e.g., positioning device 1100) housed within the second portion 2012 of the first shell member 2002 and the second shell member 2004 when they interlock and are joined together. For example, in some embodiments, the second length 2036 may be the same as or longer than the length of the positioning device 1100. In some embodiments, the second length 2036 may be shorter than the length of the positioning device 1100 but long enough to cover a sufficient portion of the positioning device (e.g., most of the positioning device or a wider or larger diameter portion) so as to prevent or hinder a user from grasping the positioning device 1100.

[0384] When the first shell member 2002 and the second shell member 2004 are assembled together (for example, interlocked and joined together), the second portion 2012 of the first shell member 2002 and the second shell member 2004 can form a second cover portion 2003 and define a cavity 2038 (Figures 69 and 72-75A). The cavity 2038 may be configured to receive a positioning device (for example, a positioning device 1100 as shown in Figures 69 and 72-75C) mounted on the distal end portion 309 of the delivery device 300, proximal to the valve mounting portion 324 of the distal end portion 309.

[0385] The inner surface of the wall of the second portion 2012 can define one half of the cavity 2038, a cavity portion 2040 (Figure 70). For example, as shown in Figure 70, the second portion 2012 of the first shell member 2002 (and the second shell 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 may be relatively planar, and its central longitudinal axis 2014 may be perpendicular to the first wall 2050. The second wall 2052 and the third wall 2054 may be curved (as shown in Figures 69-75C). The fourth wall 2056 may be relatively planar and positioned perpendicular to the first wall 2050. In some embodiments, the fourth wall 2056 may 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 (for example, in a circumferential direction or in a direction perpendicular to the central longitudinal axis 2014).

[0386] In other embodiments, as further described below with reference to Figures 76A and 76B, the second portion 2012 may not include the fourth wall 2056 (and opening 2046), and instead, the second wall 2052 and the third wall 2054 may be continuous with each other (for example, forming a single continuously curved wall that forms a complete semicylinder).

[0387] Each of the walls 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 the half-cavity portion 2040.

[0388] As shown in Figures 69 and 70, in some embodiments, the pressing portion 2026 can extend to the first inner surface 2042. In this way, the pressing portion 2026 can be continuous from the first inner surface 2042 to the distal end of the first portion 2010.

[0389] In some embodiments, the second inner surface 2044 and the third inner surface 2043 are each 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.

[0390] The second portion 2012 of the first shell member 2002 (and similarly the second shell member 2004) may further include a meshing surface 2058 configured to mesh with the corresponding meshing surface of the second shell member 2004 (as shown in Figure 71C). The meshing surface 2058 may be formed along the edges of the first wall 2050, the second wall 2052, and the third wall 2054.

[0391] In some embodiments, the meshing surface 2058 of the second portion 2012 may be continuous with (and / or in the same plane as) the inner surface 2024 of the first portion 2010. In this way, the inner surface 2024 and the meshing surface 2058 can form the entire meshing surface of the first shell member 2002 or the second shell member 2004.

[0392] In some embodiments, the meshing surface 2058 is planar or relatively planar and may include a first meshing element which may be configured as a projection (or protrusion) 2060 extending along a first portion of the meshing surface 2058 (e.g., on a first side surface of the meshing surface 2058 with respect to the central longitudinal axis 2014), and a second meshing element which may be configured as a groove (or indentation) 2062 extending along a second portion of the meshing surface 2058 (e.g., on a second side surface of the meshing surface 2058 opposite the first side surface with respect to the central longitudinal axis 2014). A detail view of the first portion of the meshing surface 2058 including the projection 2060 is shown in Figure 71A, and a detail view of the second portion of the meshing surface 2058 including the groove 2062 is shown in Figure 71B. The protrusion extends outward from the meshing surface 2058, and the groove 2062 is pressed into the meshing surface 2058.

[0393] Figure 71C is a detail view of the interlocking surface 2008 between a projection 2060 of the first shell member 2002 (for example, on a first portion of the interlocking surface 2058 of the first shell member 2002) and a groove 2062 of the second shell member 2004 (for example, on a second portion of the interlocking surface 2058 of the second shell member 2004). As shown in Figure 71C, in some embodiments, the respective interlocking surfaces 2058 of the second portions 2012 of the first shell member 2002 and the second shell member 2004 may be positioned relative to each other (for example, in face-to-face contact), and the projection 2060 of the first shell member 2002 may extend into (and interfacially contact or interlock with) the groove 2062 of the second shell member 2004. This reversal of the meshing engagement can occur in the second portion of the meshing surface 2058 of the first shell member 2002 and the second shell member 2004 (for example, on the opposite side of the balloon cover 2000, the projection 2060 of the second shell member 2004 can extend into the groove 2062 of the first shell member 2002 and interfacially contact or mesh with it).

[0394] In other embodiments, the interlocking surface 2008 between the first shell member 2002 and the second shell member 2004 may be configured differently with different interlocking or interfacial contact interlocking features (e.g., other lock-and-key or complementary mechanisms). In some embodiments, the interlocking surface 2008 between the first shell member 2002 and the second shell member 2004 may have different protruding and pressed interlocking features such as protrusions of different shapes (e.g., triangular cross-section or a series of spaced protrusions) and corresponding grooves or press-fit parts.

[0395] The configuration of the interlocking joint surface 2008, as described above, prevents the first shell member 2002 and the second shell member 2004 from sliding across each other when the assembled balloon cover 2000 is grasped or handled by a user.

[0396] When assembled in interlocking engagement (as shown in Figures 72-75C), the first shell member 2002 and the second shell member 2004 can be held or joined together via a coupling element (for example, so as not to be separated from each other). In some embodiments, as shown in Figures 69, 72, 73, and 75A, the coupling element may be configured as a sleeve 2064. In some embodiments, the sleeve 2064 may be tubular and configured to slide across and around the first interlocking portion 2010 of the first shell member 2002 and the second shell member 2004. For example, the sleeve 2064 may be configured to interlock and hold the first shell member 2002 and the second shell member 2004. As a result, the balloon cover 2000 can be held (and mounted) together on and around the distal end portion 309 of the delivery device.

[0397] As described above and as shown in Figures 72 and 73, when assembled together, the first shell member 2002 and the first portion 2010 of the second shell member 2004 can cover and enclose a portion of the distal end portion 309 of the delivery device and the balloon 318. In some embodiments, the portion of the delivery device covered by the first portion 2010 of the balloon cover 2000 may include a portion of the nose cone 322, a distal shoulder portion 326, a valve mounting portion 324, a portion of the inner shaft 308 around which the proximal end portion 333 of the balloon 318 is disposed, and a portion of the balloon 318 covering these portions of the delivery device (Figure 72).

[0398] In addition, as shown in Figures 72 and 73, when assembled together, the first shell member 2002 and the second portion 2012 of the second shell member 2004 can cover and enclose a positioning device (e.g., positioning device 1100) mounted on the distal end portion 309 of the delivery device, proximal to the valve mounting portion 324 of the distal end portion 309 of the delivery device.

[0399] In some embodiments, the first shell member 2002 and the second portion 2012 of the second shell member 2004 can cover and enclose the entire positioning device 1100. In other embodiments, the first shell member 2002 and the second portion 2012 of the second shell member 2004 can cover and enclose most of the positioning device 1100 (for example, all but most of the proximal portion, as shown in Figures 72 and 72).

[0400] When assembled together, the first shell member 2002 and the second portion 2012 of the second shell member 2004 can form a closed distal end 2066 (Figures 72, 73, and 75A) and an open proximal end 2068 (Figures 72-75C). For example, the closed distal end 2066 may be formed by the outer surface 2070 of the first wall 2050 of the first shell member 2002 and the second shell member 2004.

[0401] In other embodiments, the distal end 2066 may be at least partially open to one or more openings or windows in the first wall 2050 of the first shell member 2002 and / or the second shell member 2004.

[0402] In addition, in some embodiments (as shown in Figures 74-75C), the open proximal end 2068 may be formed by the edge portions 2072 of the second wall 2052 and the third wall 2054 of the first shell member 2002 and the second shell member 2004, respectively.

[0403] In other embodiments, the proximal end 2068 can be closed at least partially. For example, in such embodiments, the edge portion 2072 can extend radially inward to form a partial (e.g., not fully enclosed) wall.

[0404] The first shell member 2002 and the first portion 2010 of the second shell member 2004 extend distally from the closed distal end 2066 in the axial direction.

[0405] The outer walls of the first shell member 2002 and the second portion 2012 of the second shell member 2004 can form the second cover portion 2003 of the balloon cover 2000, and can provide a surface for the user to grasp and / or grip when the sleeve 2064 is detached from the first portion 2010 and slid away (so that the balloon cover 2000 can be removed from the delivery device).

[0406] When the first shell member 2002 and the second portion 2012 of the second shell member 2004 are assembled to form a second cover portion 2003, a cylindrical enclosure (e.g., a cylinder) can be formed. The internal dimensions of the cylindrical enclosure can define a cavity 2038. For example, the second cover portion 2003 may have an internal diameter 2074 and an internal height 2076 (Figures 74 and 75B). The internal height 2076 can be defined between the fourth inner surface 2048 of the fourth wall 2056 of the first shell member 2002 and the fourth inner surface 2048 of the fourth wall 2056 of the second shell member 2004 (Figure 74). The internal diameter 2074 can be defined between curved walls (e.g., the second wall 2052, as shown in Figure 74) located on the opposite sides of the first shell member 2002 and the second shell member 2004.

[0407] As shown in Figures 75B and 75C, the inner diameter 2074 and inner height 2076 may be selected based on the maximum dimensions of the positioning device to be housed in the cavity 2038. For example, the inner diameter 2074 and inner height 2076 may be selected so that the flange portion 1112 of the positioning device 1100 fits into the cavity 2038 without touching (e.g., being separated from) the second inner surface 2044 and the third inner surface 2043 of the first shell member 2002 and the second shell member 2004. For example, the inner diameter 2074 may be larger than the outer diameter of the flange portion 1112.

[0408] In some embodiments, the inner height 2076 may be the same as or slightly smaller than the outer diameter of the flange portion 1112. For example, in some embodiments, as shown in Figure 75C, one or more portions of the flange portion 1112 of the positioning device 1100 (e.g., extended portions 1114) may extend into one of the openings 2046 (e.g., between the fourth inner surface 2048 and the outer surface of the fourth wall 2056).

[0409] Therefore, when a user grasps the outside of the second cover portion 2003 (for example, to remove the sleeve 2064), any movement of the balloon cover 2000 will not result in movement of the positioning device 1100 relative to the delivery device, since the balloon cover 2000 does not directly contact the positioning device 1100. For example, if the balloon cover 2000 is rotated, this rotation will not result in rotation of the positioning device 1100, thereby maintaining the positioning device in a specific and intended circumferential position relative to the delivery device. This allows the artificial valve to be mounted on the valve mounting portion of the delivery device in a predetermined circumferential orientation relative to the radiation marker on the delivery device, as discussed herein (for example, as discussed above with reference to Figure 57).

[0410] In some embodiments, as shown in Figures 74-75C, the inner height 2076 may be smaller than the inner diameter 2074. Correspondingly, the second cover portion 2003 may have an outer height 2078 smaller than the outer diameter 2080 (Figure 75B). The reduced inner height 2076 and outer height 2078 can reduce the overall packaging space of the balloon cover 2000 compared to the corresponding diameter of the second cover portion 2003. This can reduce the material cost of the balloon cover itself and the packaging material used to house the balloon cover. Thus, the inner diameter 2074 and inner height 2076 may be selected to be as small as possible to reduce the packaging space, while still being large enough to prevent engagement with positioning equipment (Figure 76C).

[0411] In some embodiments, the configuration of the opening 2046 in the fourth wall 2056 of the first shell member 2002 and the second shell member 2004 can result in a reduced inner height 2076 and outer height 2078.

[0412] In some embodiments, the opening 2046 may also allow the user to visualize the distal end portion 309 of the positioning device 1100 and the delivery device 300, which may allow for easier assembly of the balloon cover 2000 around the delivery device.

[0413] In other embodiments, the second cover portion 2003 may be cylindrical, and the first shell member 2002 and the second shell member 2004 may have walls that completely enclose the positioning device therein without any openings. For example, Figures 76A and 76B show another exemplary embodiment of the balloon cover 2100, comprising a first shell member 2102 and a second shell member 2104 configured to interlock with each other and to be detachably coupled to each other.

[0414] Except that the first shell member 2102 and the second shell member 2104 do not include an opening 2046, and the inner diameter 2106 and outer diameter 2108 of the second cover portion 2110 (similar to the second cover portion 2003) are constant around the circumference of the second cover portion 2110 (Figure 76B), 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 cover 2000 (Figures 69-75C). Therefore, the second cover portion 2110 does not have a reduced height (compared to the balloon cover 2000). Thus, the balloon cover 2100 (Figures 76A and 76B) can increase the packaging space compared to the balloon cover 2000 (Figures 69-75C).

[0415] Figures 108–114 show another embodiment of a balloon cover 2600 configured to cover a portion of the distal end portion of a delivery device (e.g., the distal end portion 309 of the delivery device 300), including an inflatable balloon mounted thereon (e.g., balloon 318) and a positioning device (e.g., positioning device 1100) coupled to the distal end portion of the delivery device proximal to the valve mounting portion of the delivery device. The balloon cover 2600 may be similar to the balloon cover 2000 in Figures 69–75C, except that it is configured to receive a portion of the positioning device and prevent rotation of the positioning device and the balloon cover 2600 relative to each other. For example, independent rotation between the positioning device and the balloon cover 2600 may result in torsion of the balloon, thereby causing unpredictable rotation of the prosthetic heart valve during valve deployment at the implantation site (and thus uncertainty regarding the positioning of the prosthetic valve commissure relative to the natural valve commissure).

[0416] The balloon cover 2600 comprises a first cover portion 2601 configured to cover at least a portion of the distal end of the delivery device including the balloon, and a second cover portion 2603 configured to cover the positioning device. The balloon cover 2600 may also comprise a first shell member 2602 and a second shell member 2604 configured to interlock with each other and to be removably coupled to each other (Figures 110 and 113). For example, the first shell member 2602 and the second shell member 2604 may comprise two halves of the balloon cover 2600 and / or the outer shell 2606 that forms it (Figure 110).

[0417] The outer shell 2606 and balloon cover 2600 are shown in an exploded configuration in the exploded view of Figure 110, and in an assembled configuration in various figures 108, 109, 111, and 113. Furthermore, Figure 113 shows a cross-sectional view of the balloon cover 2600, while Figure 114 shows one of the shell members (e.g., the first shell member 2602) arranged around the delivery device.

[0418] In some embodiments, the first shell member 2602 and the second shell member 2604 may have interlocking surfaces 2008 similar to or the same as those described above with reference to Figures 71A to 71C.

[0419] Each of the first shell member 2602 and the second shell member 2604 includes a first portion (e.g., first shell portion) 2610 and a second portion (e.g., second shell portion) 2612. In some embodiments, the first portion 2610 and the second portion 2612 of one of the first shell member 2602 and the second shell member 2604 may be continuous with each other (e.g., formed as a single piece). Similar to the balloon cover 2000, the second portion 2612 of the balloon cover 2600 may have a greater width than the first portion 2610.

[0420] When the first shell member 2602 and the second shell member 2604 are assembled together (for example, by interlocking), the first portion 2610 of the first shell member 2602 and the second shell member 2604 can form a first cover portion 2601 and define an elongated cavity 2620 (Figures 110 and 113). The cavity 2620 may be configured to receive at least a portion (for example, a majority in some embodiments) of the distal end portion of the delivery device and the balloon mounted on the distal end portion of the delivery device (for example, the balloon 318 on the distal end portion 309, as shown in Figures 110, 113, and 114).

[0421] For example, the first portion 2610 of the first shell member 2602 (and similarly the second shell member 2604) comprises an outer surface (a surface facing radially outward) 2622 (Figures 110, 112, and 113) and an inner surface (a surface facing radially inward) 2624 (Figures 110 and 114). The inner surface 2624 may be an interlocking surface configured to interlock or engage (e.g., face-to-face contact) with each inner surface of the first portion 2610 of the other (e.g., second) shell member forming the balloon cover 2600. In some embodiments, the inner surface 2624 may be planar.

[0422] In some embodiments, one first portion 2610 of a shell member (a second shell member 2604 as shown in Figures 110 and 112) may include an opening or window 2660 positioned through an outer surface 2622 and an inner surface 2624, such that a marker 600 on the distal shoulder (or another marker on the distal end portion of the delivery device) can be made visible to the user when the balloon cover is coupled to the delivery device, as described herein.

[0423] The first portion 2610 may further include a pressing portion 2626 that is pressed into the inner surface 2624 (towards the outer surface 2622, as shown in Figures 110 and 114). Together, the pressing portions 2626 of the first shell member 2602 and the second shell member 2604 may form a cavity 2620.

[0424] Each press portion 2626 may be molded to receive a portion of the distal end portion 309 of the delivery device. For example, each press portion 2626 may include a distal section 2628 and a proximal section 2630 (Figure 110). In some embodiments, the distal section 2628 may be molded (e.g., configured) to receive a balloon (e.g., balloon 318) and a portion of the delivery device over which the balloon overlaps. For example, in embodiments shown in Figures 108-114, the distal section 2628 may be molded to receive a portion of the nose cone 322 and the distal end portion 332 of balloon 318 overlapping the distal shoulder portion 326 of the delivery device 300 (Figures 110, 113, and 114).

[0425] In some embodiments, the proximal section 2630 may be molded (e.g., configured) to receive the intermediate portion 335 of the balloon and a portion of the delivery device 300 (e.g., the valve mounting portion 324) that overlaps with the intermediate portion 335. In some embodiments, the proximal section 2630 may also be molded to receive at least the distal portion of the proximal end portion 333 of the balloon 318, although in the embodiments shown in Figures 108-114, the proximal end portion 333 of the balloon 318 may have the same outer shape or diameter as the intermediate portion 335. Thus, the proximal section 2630 may have a constant or relatively constant width along its length (or most of its length) from the distal section 2628 to the second portion 2612 of the shell member. In other embodiments, each pressing portion 2626 may be molded similarly to the pressing portion 2026 of the balloon cover 2000 shown in Figures 69-75C.

[0426] In this way, the shape or contour of the pressing portion 2626 may vary along the length of the first portion 2610. For example, as shown in Figures 110, 113, and 114, the proximal section 2630 is narrower than the distal section 2628.

[0427] In some embodiments, the length of the first portion 2610 may be longer than the length of the second portion 2612, as described above with reference to Figures 69-75C.

[0428] The second portion 2012 of each of the first shell member 2602 and the second shell member 2604 may be configured (sized and molded) based on the length and / or size of a positioning device (e.g., positioning device 1100) that will be housed within the second portion 2612 of the first shell member 2602 and the second shell member 2604 when they interlock and are joined together.

[0429] When the first shell member 2602 and the second shell member 2604 are assembled together (e.g., interlocked and joined together), the second portion 2612 of the first shell member 2602 and the second shell member 2604 can form a second cover portion 2603 and define a cavity 2638 (Figures 108 and 111-114). The cavity 2638 may be configured to receive a positioning device (e.g., a positioning device 1100, as shown in Figures 108-114) mounted on the distal end portion 309 of the delivery device 300, proximal to the valve mounting portion 324 of the distal end portion 309. In some embodiments, the overall dimensions of the cavity 2638 may be similar to those of the cavity 2038 of the balloon cover 2000, as described above, except for one or more cavities 2652 which are further described below.

[0430] Similar to the balloon cover 2000 (Figures 69-75C), the inner surface of the wall of the second portion 2612 can define one half of the cavity portion of the cavity 2638. In some embodiments, the second portion 2612 of the second shell member 2604 may be identical or similar to the second portion 2012 of the first and second shell members 2002 and 2004 of the balloon cover 2000 (see the description of Figures 69-75C above). However, the second portion 2612 of the first shell member 2602 may have a first wall 2650 (a wall connecting to the first portion 2610) which is molded to receive a portion of the positioning device 1100 (for example, having a keyway). For example, the first wall 2650 of the second portion 2612 of the first shell member 2602 may be molded to form one or more cavities 2652 that are molded to receive and hold a portion of the flange portion 1112 of the positioning device 1100 (Figures 110, 113, and 114). In some embodiments, the second portion 2612 of the first shell member 2602 may include one or more protruding wall portions 2654 that are part of the first wall 2650 or extend therefrom and project into the cavity 2638, forming one or more cavities 2652 (Figures 108, 110, 113, and 114).

[0431] By configuring the first wall 2650 of the second portion 2612 of the first shell member 2602 to have one or more cavities 2652, the balloon cover 2600 and the positioning device 1100 are prevented from rotating relative to each other when the balloon cover 2600 is coupled to the delivery device and around the positioning device 1100. As a result, twisting of the balloon 318 can be avoided.

[0432] In some embodiments, one of the shell portions of any of the other balloon covers described herein (see, for example, Figures 69-86) may have a second portion comprising one or more cavities 2652 that are molded to receive and hold within a portion of the flange portion 1112 of the positioning device 1100, as described above with reference to Figures 108-114.

[0433] Returning to Figures 108-114, the remaining wall of the second portion 2612 of the first shell member 2602 may be similar to the wall of the second shell member 2604. As described above with reference to the balloon cover 2000, the second portion 2612 of the balloon cover 2600 may define an opening 2646.

[0434] When assembled in interlocking engagement (as shown in Figures 108, 109, and 111-113), the first shell member 2602 and the second shell member 2604 can be held or joined together via a coupling element (for example, so as not to be separated from each other). In some embodiments, the coupling element may be configured as a sleeve 2664. The sleeve 2664 may be identical or similar to the sleeve 2064 of the balloon cover 2000.

[0435] As described above, when assembled together, the first shell member 2602 and the first portion 2610 of the second shell member 2604 can cover and enclose a portion of the distal end portion 309 of the delivery device and the balloon 318 (Figures 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, a distal shoulder portion 326, a valve mounting portion 324, a portion of the inner shaft 308, and a portion of the balloon 318 that covers these portions of the delivery device (Figures 113 and 114).

[0436] Referring to Figures 69-75C, similar to those described above, 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 cover portion 2603 of the balloon cover 2600, providing a surface for the user to grip and / or hold when sliding the sleeve 2664 away from the first portion 2610 (so that the balloon cover 2600 can be removed from the delivery device) without gripping the positioning device 1100.

[0437] As described above with reference to Figures 38-41, the distal end portion 309 of the delivery device 300 may include a distal tip portion 900 mounted on or positioned on the distal end of the outer shaft 304. In some embodiments, after the artificial valve is mounted radially compressed around the valve mounting portion 324 of the delivery device 300, the outer shaft 304 and the intermediate shaft (e.g., balloon shaft) 306 may be moved axially relative to each other so that the distal tip portion 900 is positioned over the proximal end portion 333 of the balloon 318. As a result, the distal tip portion 900 acts as a proximal shoulder on the proximal side of the valve mounting portion 324 while the distal end portion of the delivery device is advanced to the target implantation site, resisting the movement of the radially compressed artificial valve axially proximal.

[0438] As previously described, before the artificial valve is crimped around the valve mounting portion 324, the balloon 318 may undergo a periodic degassing process in which the expansion fluid is introduced into the balloon and then drawn out. The process of introducing the expansion fluid into the balloon 318 and then drawing out the expansion fluid may be repeated one or more times as needed. 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 tip portion 333 of the balloon 318) to facilitate the flow of the expansion fluid into the proximal end portion 333 of the balloon 318. In some embodiments, the degassing process may be performed while the balloon 318 is housed in the balloon cover. After the degassing process, the balloon cover can be removed from the balloon, and the outer shaft 304 can be moved to a more distal position extending axially across the proximal end portion 333 of the balloon 318 relative to the intermediate shaft 306 (and inner shaft 308) (as shown in Figure 41). As the distal tip portion 900 is moved distally across the proximal tip portion 333, residual fluid in the proximal tip portion 333 of the balloon from the degassing process can be pushed distally into the middle portion 335 and distal tip portion 332 of the balloon 318.

[0439] As described above, to accommodate this residual fluid without increasing the crimped shape of the artificial valve on the delivery device, the radial pressure portion 334 can be initially formed on the distal end portion 332 of the balloon 318 (for example, before moving the distal tip portion 900 across the proximal end portion 333 of the balloon 328, Figure 40). When the residual inflated fluid in the proximal end portion 333 of the balloon 318 is “compressed” or pushed into the distal end portion 332 of the balloon 318 by advancing the distal tip portion 900, the displaced residual fluid can expand the distal end portion 332 of the balloon 318 from the radially compressed state shown in Figure 40 to the expanded state 924 shown in Figure 41 (and shown by a dashed line in Figure 40). As a result, undesirable expansion of the intermediate portion 324, which could thereby expand the crimped shape of the artificial valve, can be avoided.

[0440] Various techniques and mechanisms can be used to achieve the balloon shape shown in Figure 40, which includes a balloon cover having an internal cavity that is molded to produce a desired balloon shape (e.g., radially compressed portion 334).

[0441] Figures 77–83B show exemplary embodiments of a balloon cover 2200 configured to receive (and cover) a portion of the distal end portion of a delivery device (e.g., the distal end portion 309 of the delivery device 300, as shown in Figure 77), including an inflatable balloon mounted thereon (e.g., balloon 318). In some embodiments, the balloon cover 2200 is also configured to receive a positioning device (e.g., a positioning device 1100, as shown in Figures 53–55 and 77) coupled to the distal end portion of the delivery device proximal to the valve mounting portion of the delivery device.

[0442] More specifically, the balloon cover 2200 is configured to receive and create a specific final shape of the balloon 318 (e.g., the shape shown in Figure 40, including a radial press portion 334). For example, Figure 77 is an exploded view of the balloon cover 2200 configured to be assembled around the distal end portion 309 of the delivery device 300. Cross-sectional views of the assembled balloon cover 2200 are shown in Figures 83A and 83B. As will be fully described below, the balloon cover 2200 may be similar to the balloon cover 2100 described above with reference to Figures 69-75C, except for the addition of a press sleeve configured to receive the distal end portion 332 of the balloon 318 and a first cavity (formed by the press portion of the shell member) configured to receive the middle portion 335 and the proximal end portion 333 of the balloon 318.

[0443] As shown in Figures 77 and 83A, the balloon cover (or balloon cover assembly) 2200 comprises a first cover portion 2201 configured to cover at least a portion of the distal end of the delivery device including the balloon. The balloon cover 2200 may further comprise a second cover portion 2203 configured to cover the positioning device (Figures 77 and 83A).

[0444] The balloon cover 2200 may comprise a first shell member 2202 and a second shell member 2204 configured to interlock with each other and to be removably coupled to each other (similar to the first shell member 2002 and the second shell member 2004 of the balloon cover 2000). For example, the first shell member 2202 and the second shell member 2204 may comprise two halves of the shell 2206 of the balloon cover 2200 (Figures 77, 83A, and 83B).

[0445] The balloon cover 2200 may further comprise a press sleeve 2240 (which may also be referred to as a press cap, member, or tube). The press sleeve 2240 may be configured to form the shape (e.g., a recessed or pressed shape) of a portion of the balloon of the delivery device (e.g., a radial press portion 334 within the distal end portion 332 of the balloon 318). The press sleeve 2240 is described in further detail below with reference to various figures in Figures 78-81B.

[0446] In some embodiments, the balloon cover 2200 may further comprise a coupling element, which in some embodiments may be a tubular sleeve (e.g., an outer sleeve) 2264 configured to cover at least a portion of the pressing sleeve 2240 and to press one or more pressing members 2256 of the pressing sleeve 2240 in a radially inward direction toward the central longitudinal axis 2214 in order to form a negative pressing portion on one or more parts of the balloon.

[0447] In some embodiments, the sleeve 2264 may also be configured to interlock with each other (as shown, for example, in Figures 83A and 83B) to hold the first shell member 2202 and the second shell member 2204. The sleeve 2264 may be identical to or similar to the sleeve 2064 as described above.

[0448] The balloon cover 2200 is shown in an exploded configuration in the exploded view of Figure 77, and in an assembled configuration in various diagrams of Figures 83A and 83B. Figure 82 shows the first shell member 2202 disassembled from the rest of the balloon cover 2200. However, in some embodiments, the first shell member 2202 and the second shell member 2204 may be identically constructed (e.g., identically formed), so the first shell member shown in Figure 82 may alternatively be the second shell member 2204. In addition, Figures 78-81B show different diagrams of the push sleeve 2240 alone.

[0449] As shown in Figures 77 and 82, in some embodiments, each of the first shell member 2202 and the second shell member 2204 includes a first portion (e.g., first shell portion) 22...

Claims

1. An assembly including an artificial heart valve, wherein the artificial heart valve is Around the inflatable balloon of the delivery device, and in a radially compressed state, With respect to the delivery device, at a predetermined position and orientation, The selected commissure of the artificial heart valve is offset by a predetermined amount from a desired marker on the delivery device in the circumferential direction with respect to the central longitudinal axis of the delivery device. Mounted at the distal end of the aforementioned delivery device, The predetermined amount of offset is pre-selected based on a desired or selected imaging view used to image the distal end of the delivery device during the implantation procedure and to align the artificial heart valve in the rotational direction with respect to the natural anatomical structure of the assembly.

2. The assembly according to claim 1, wherein the desired mark is a marker placed on the polymer body of the delivery device.

3. The assembly according to claim 2, wherein the marker is positioned offset axially from the artificial heart valve.

4. The assembly according to claim 2 or 3, wherein the marker has a rectangular shape.

5. An assembly according to any one of claims 1 to 4, wherein the delivery device is a balloon catheter, and the balloon catheter is The handlebars and A movable outer shaft extending from the handle, An intermediate shaft extends from the handle, passing coaxially through the aforementioned movable outer shaft, An inner shaft extending from the handle, passing coaxially through the intermediate shaft and the movable outer shaft, An inflatable balloon extending from the distal end of the aforementioned intermediate shaft, A nose cone positioned at the distal end of the delivery device, Includes, The distal end of the delivery device is an assembly including the balloon, the nose cone, and the balloon shoulder assembly.

6. The assembly according to claim 5, wherein the balloon shoulder assembly is configured to maintain the artificial heart valve in a fixed position on the balloon while it is being delivered through the patient's vascular system.

7. An assembly according to claim 5 or 6, wherein the balloon shoulder assembly includes a proximal shoulder and / or distal shoulder.

8. An assembly according to any one of claims 5 to 7, wherein the handle includes a steering mechanism configured to adjust the curvature of the distal end of the delivery device, The assembly comprising a handle including an adjustment member such as a rotatable knob, the adjustment member being operatively connected to the proximal end of a pull wire, the pull wire extending distally from the handle through the outer shaft, and having a distal end fixed to the outer shaft at or near the distal end of the outer shaft.

9. An assembly according to any one of claims 1 to 8, wherein, by a predetermined amount of circumferential offset with respect to the selected imaging view, the artificial heart valve is embedded in the natural valve with its commissures aligned with those of the natural valve. Preferably, the desired or selected imaging view used to image the distal end of the delivery device during the implantation procedure and to align the artificial heart valve with the natural anatomical structure in the rotational direction is a tricuspid valve imaging view of the natural valve, in the assembly.

10. The step includes pressing an artificial heart valve radially compressed against the distal end of the delivery device at a predetermined position and orientation relative to the delivery device, The compressed artificial heart valve is positioned on the delivery device such that the selected commissure of the artificial heart valve is offset circumferentially by a predetermined amount from a desired marker on the delivery device. A method wherein the predetermined amount of offset is determined based on a desired or selected imaging view used to image the distal end of the delivery device during the implantation procedure and to rotate the artificial heart valve relative to the natural anatomical structure.

11. A method according to claim 10, wherein the artificial heart valve is embedded in the natural valve such that the commissure is aligned with the commissure of the natural valve by a predetermined amount of circumferential offset with respect to the selected imaging view.

12. A method according to claim 11, further comprising selecting a commissure of a natural valve that forms at least a partial basis for the predetermined offset between the desired landmark and the selected commissure of the artificial heart valve.

13. A method according to claim 12, further comprising selecting one imaging view from a plurality of possible imaging views, and predetermining the circumferential position of the selected commissure of the natural valve with respect to the back or front of the selected imaging view.

14. A method according to any one of claims 10 to 13, further comprising the use of a matching ring configured such that the artificial heart valve is radially compressed on the delivery device, with the selected commissure being circumferentially offset from the desired marker on the delivery device by a predetermined amount determined based on the selected imaging view used during the implantation procedure.

15. A method according to claim 14, further comprising using a pre-procedure imaging modality to measure the offset of the natural valve commissure from an expected position, and using the matching ring to offset the commissure of the artificial heart valve based on this measurement.

Images