Prosthetic heart valve delivery system and methods

Abstract

Valve positioning structures for use in a prosthetic heart valve delivery apparatus and associated methods. The delivery apparatus can include a balloon coupled to a distal end portion of a shaft and a valve positioning structure can be disposed around the balloon, and a prosthetic heart valve can be crimped around the balloon and the valve positioning structure. The valve positioning structure can include a support structure, such as a frame or a braided wire mesh, which can be coated with a polymeric coating to protect the balloon and the prosthetic valve. In some examples, the polymeric coating is an open-cell polymeric coating. In some examples, the polymeric coating is a closed-cell polymeric coating. In some examples, a webbing portion of the closed-cell polymeric coating spanning across the cells of the support structure can be formed while the support structure is in an at least partially expanded state.

Description

THVMC-23950W001PROSTHETIC HEART VALVE DELIVERY SYSTEM AND METHODSCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 683,630, filed August 15, 2024, which is incorporated by reference herein in its entirety.FIELD

[0002] The present disclosure relates to delivery systems for prosthetic heart valves and associated methods, and in particular to delivery systems with inflatable balloons and valve positioning structures for deploying prosthetic heart valves.BACKGROUND

[0003] The human heart can suffer from various valvular diseases. These valvular diseases can result in significant malfunctioning of the heart and ultimately require repair of the native valve or replacement of the native valve with an artificial valve. There are a number of known repair devices (for example, stents) and artificial valves, as well as a number of known methods of implanting these devices and valves in humans. Percutaneous and minimally-invasive surgical approaches are used in various procedures to deliver prosthetic medical devices to locations inside the body that are not readily accessible by surgery or where access without surgery is desirable. In one specific example, a prosthetic heart valve can be mounted in a crimped state on the distal end portion of a delivery apparatus and advanced through the patient’ s vasculature (for example, through a femoral artery and the aorta) until the prosthetic heart valve reaches the implantation site in the heart. The prosthetic heart valve is then expanded to its functional size, for example, by inflating a balloon on which the prosthetic valve is mounted, actuating a mechanical actuator that applies an expansion force to the prosthetic heart valve, or by deploying the prosthetic heart valve from a sheath of the delivery apparatus so that the prosthetic heart valve can selfexpand to its functional size.SUMMARY

[0004] Described herein are prosthetic heart valves, delivery apparatuses, delivery systems, and methods for implanting prosthetic heart valves. The disclosed prosthetic heart valves,THVMC-23950W001 delivery apparatuses, delivery systems, and methods can, for example, provide for improved positioning of a prosthetic heart valve on a delivery apparatus, for example, during advancement of the delivery apparatus through a patient’s vasculature, among other things. As such, the devices and methods disclosed herein can, among other things, provide improved balloon expandable delivery systems.

[0005] A delivery system for a prosthetic implant can comprise a handle and one or more shafts coupled to the handle.

[0006] In some examples, the delivery system can comprise a balloon coupled to a distal end portion of the one or more shafts.

[0007] In some examples, the balloon can be configured to be inflated from a first, deflated state to a second, radially expanded, inflated state.

[0008] In some examples, the delivery system can include a first valve positioning structure.

[0009] In some examples, the first valve positioning structure can extend at least partially over an exterior surface of the balloon and can have a first end portion and a second end portion.

[0010] In some examples, the first valve positioning structure can be configured to radially expand from a radially collapsed state to a radially expanded state when the balloon is inflated.

[0011] In some examples, the first valve positioning structure can resiliently radially collapse from the radially expanded state to the radially collapsed state when the balloon is deflated.

[0012] In some examples, the first valve positioning structure can comprise a frame constructed of a shape-memory material.

[0013] In some examples, the frame can be shape set in the radially collapsed configuration.

[0014] In some examples, the first valve positioning structure can extend around the exterior surface of the balloon at the first end portion.

[0015] In some examples, the first valve positioning structure can extend around the exterior surface of the balloon at both the first end portion and the second end portion of the balloon.

[0016] In some examples, the first valve positioning structure can comprise a proximal valve positioning portion and a distal valve positioning portion.THVMC-23950W001

[0017] In some examples, the first valve positioning structure can include an intermediate valve positioning portion disposed between the proximal and distal valve positioning portions.

[0018] In some examples, the proximal valve positioning portion can be coupled to the shaft.

[0019] In some examples, the delivery system can further comprise a nose cone distally disposed relative to the balloon.

[0020] In some examples, the distal valve positioning portion can be coupled to the nose cone.

[0021] In some examples, the intermediate valve positioning portion can be configured to receive the prosthetic valve.

[0022] In some examples, the distal valve positioning portion can have an outer diameter that is greater than an outer diameter of the intermediate valve positioning portion.

[0023] In some examples, the proximal valve positioning portion can have an outer diameter that is greater than an outer diameter of the intermediate valve positioning portion.

[0024] In some examples, the distal valve positioning portion can comprise a plurality of struts.

[0025] In some examples, the plurality of struts can include a first plurality of struts arranged in a first row that extends in a circumferential direction of the delivery system.

[0026] In some examples, the plurality of struts can include a second plurality of struts arranged in a second row that extends in the circumferential direction.

[0027] In some examples, each one of the first plurality of struts can be a linear strut oriented at an angle relative to an axial direction of the delivery system.

[0028] In some examples, each one of the first plurality of struts can be a linear strut oriented in an axial direction of the delivery system.

[0029] In some examples, each one of the second plurality of struts can be a serpentine strut.

[0030] In some examples, each one of the second plurality of struts can be a zigzag strut.

[0031] In some examples, the balloon can have an axial length in a range from 45 mm to 51 mm.

[0032] In some examples, the balloon can have an axial length in a range from 31 mm to 45 mm.

[0033] In some examples, the balloon can have an axial length in a range from 25 mm to 31 mm.THVMC-23950W001

[0034] In some examples, the frame can comprise a braided mesh structure.

[0035] In some examples, the first valve positioning structure can comprise a polymeric coating attached to the frame.

[0036] In some examples, the delivery system can further comprise a second valve positioning structure extending over the exterior surface of the balloon.

[0037] In some examples, the first valve positioning structure and the second valve positioning structure can be spaced apart in an axial direction of the delivery system.

[0038] In some examples, the first valve positioning structure and the second valve positioning structure can define a valve mounting portion of the delivery system configured to receive the prosthetic valve.

[0039] In some examples, neither the first valve positioning structure nor the second valve positioning structure can extend over an outer surface of the prosthetic valve when the prosthetic valve is mounted over the valve mounting portion.

[0040] In some examples, the delivery system can further comprise at least one tether connected to the first valve positioning structure.

[0041] In some examples, the at least one tether can be configured to cause the first valve positioning structure to further radially collapse when the first valve positioning structure is in the radially collapsed state and tension is increased in the tether.

[0042] In some examples, the first valve positioning structure can extend an entire length of the balloon.

[0043] In some examples, the first valve positioning structure is configured such that it does not overlap or extend over any portion of an outer surface of an implant (for example, a prosthetic heart valve) mounted in a radially compressed state on a balloon of the delivery system.

[0044] In some examples, the first valve positioning structure is configured such that it does not overlap or extend over any portion of an outer surface of an implant (for example, a prosthetic heart valve) mounted in a radially compressed on the first valve positioning structure.

[0045] In some examples the first valve positioning structure is configured such that when an implant (for example, a prosthetic heart valve) is mounted in a radially compressed state on the first valve positioning structure, no portion of the implant contacts the balloon of the delivery system.THVMC-23950W001

[0046] In some examples, a valve positioning can include a closed-cell polymeric coating where cells of the frame are closed by a webbing portion of the polymeric coating.

[0047] In some examples, the webbing portion is configured to limit over stretching of the webbing portion when the valve positioning is transitioned from a radially collapsed state or a radially compressed state to a radially expanded state.

[0048] In some examples, the webbing portion is configured to resist tearing when the valve positioning is transitioned from a radially collapsed state or a radially compressed state to a radially expanded state.

[0049] In some examples, a valve positioning structure can include an open-cell polymeric coating where cells of the frame are open.

[0050] In some examples, a delivery apparatus comprises: a handle, a shaft, a balloon, and a valve positioning structure. The shaft can be coupled to the handle. The balloon can be coupled to a distal end portion of the shaft. The balloon can be configured to be inflated from a first, deflated state to a second, radially expanded, inflated state. The balloon can include a valve mounting portion for mounting the prosthetic valve in a radially compressed state. The valve positioning structure can extend at least partially over an exterior surface of the balloon and can have a first end portion and a second end portion. The valve positioning structure can be configured to radially expand from a radially collapsed state to a radially expanded state when the balloon is inflated and then resiliently radially collapse from the radially expanded state to the radially collapsed state when the balloon is deflated.

[0051] In some examples, a delivery system for delivering a prosthetic valve through vasculature of a patient can comprise: a radially expandable prosthetic valve and a delivery apparatus. The delivery apparatus can comprise: a handle, a shaft, an expandable distal valve positioning structure, and a an expandable proximal valve positioning structure. The shaft can be coupled to the handle and a balloon coupled to a distal end portion of the shaft. The balloon can be configured to be inflated from a first, deflated state to a second, radially expanded, inflated state. The prosthetic valve can be mounted on the balloon in a radially compressed state. The expandable distal valve positioning structure can be disposed on an exterior surface of a distal end portion of the balloon. The expandable proximal valve positioning structure can be disposed on an exterior surface of a proximal end portion of the balloon. The distal and proximal valve positioning structures can be configured to radially expand from a radially collapsed state to a radially expanded state when the balloon isTHVMC-23950W001 inflated and then radially collapse from the radially expanded state to the radially collapsed state when the balloon is deflated.

[0052] In some examples, a delivery system for delivering a prosthetic valve through vasculature of a patient can comprise: a radially expandable prosthetic valve and a delivery apparatus. The delivery apparatus can comprise: a handle, a shaft, and an expandable valve positioning structure. The shaft can be coupled to the handle and a balloon coupled to a distal end portion of the shaft. The balloon can be configured to be inflated from a first, deflated state to a second, radially expanded, inflated state. The prosthetic valve can be mounted on the balloon in a radially compressed state. The expandable valve positioning structure can be disposed on an exterior surface of a portion of the balloon. The valve positioning structure can be configured to radially expand from a radially collapsed state to a radially expanded state when the balloon is inflated and then resiliently radially collapse from the radially expanded state to the radially collapsed state when the balloon is deflated.

[0053] In some examples, a delivery apparatus for delivering a prosthetic valve through vasculature of a patient can comprise: a handle, a balloon catheter, and a first valve positioning structure. The balloon catheter can comprise a shaft coupled to the handle and a balloon connected to a distal end portion of the shaft. The balloon can be configured to be inflated from an uninflated state to an inflated state. The first valve positioning structure can extend over an exterior surface of the balloon. The first valve positioning structure can comprise a first frame constructed of a shape-memory material. The first frame can be shape set in a radially compressed configuration.

[0054] In some examples, a delivery apparatus for delivering a prosthetic valve through vasculature of a patient can comprise: a handle, a shaft, a balloon, and a valve positioning system. The shaft can be coupled to the handle. The balloon can be coupled to a distal end portion of the shaft. The balloon can be configured to be inflated from a first, deflated state to a second, radially expanded, inflated state. The balloon can have a proximal end portion, a distal end portion, and a valve mounting portion disposed between the proximal and distal end portions for mounting the prosthetic valve in a radially compressed state. The valve positioning structure can comprise a frame, wherein the valve positioning structure can be positioned radially outward of the balloon, the valve positioning structure can extend over the proximal end portion of the balloon, the valve mounting portion of the balloon, and the distal end portion of the balloon, and the valve positioning structure can be configured to radiallyTHVMC-23950W001 expand from a radially collapsed state to a radially expanded state when the balloon is inflated and then radially collapse from the radially expanded state to the radially collapsed state when the balloon is deflated.

[0055] In some examples, a delivery apparatus for a prosthetic medical device can comprise a handle, a shaft, a balloon, and a valve positioning system. The shaft can be coupled to the handle. The balloon can be coupled to a distal end portion of the shaft. The valve positioning structure can extend at least partially over an outer surface of the balloon, wherein the valve positioning structure can comprise a frame constructed of a shape-memory material.

[0056] In some examples, a delivery apparatus for a prosthetic medical device can comprise: a handle, a shaft, a balloon, and a valve positioning structure. The shaft can be coupled to the handle. The balloon can be coupled to a distal end portion of the shaft and can comprise an outer surface. The valve positioning structure can extend at least partially over the outer surface of the balloon and can comprise a frame that includes a plurality of struts. The frame can define an axial direction and a circumferential direction.

[0057] In some examples, a delivery system can comprise: a balloon, an expandable distal valve positioning structure, an expandable proximal valve positioning structure, and a prosthetic heart valve. The balloon can comprise: an outer surface extending from a distal end to a proximal end of the balloon and a valve mounting portion disposed on the outer surface between the distal and proximal ends. The expandable distal valve positioning structure can extend over a distal portion of the outer surface of the balloon. The expandable proximal valve positioning structure can extend over a proximal portion of the outer surface of the balloon. The prosthetic heart valve can be crimped around the valve mounting portion of the balloon, wherein neither the distal valve positioning structure nor the proximal valve positioning structure can overlap an outer surface of the prosthetic heart valve.

[0058] In some examples, a delivery apparatus can comprise: a shaft; a balloon mounted on a distal end portion of the shaft; and a valve positioning structure mounted over the balloon, the valve positioning structure comprising: a support structure comprising one of a frame or a wire mesh structure, the support structure defining a plurality of cells; and a closed-cell polymeric coating encapsulating at least a portion of the support structure, wherein a webbing portion of the closed-cell polymeric coating is configured to fold when the support structureTHVMC-23950W001 is in a radially collapsed state and is configured to resist tearing when the support structure is transitioned from the radially collapsed state to a radially expanded state.

[0059] In some examples, a delivery apparatus can comprise: a shaft; a balloon mounted on a distal end portion of the shaft; and a valve positioning structure mounted over the balloon, the valve positioning structure comprising: a support structure comprising one of a frame or a wire mesh structure, the support structure defining a plurality of cells; and an open-cell polymeric coating encapsulating at least a portion of the support structure, wherein each of the cells is open.

[0060] In some examples, a delivery apparatus comprises one or more of the components recited in Examples 1-152 or 199-209 below.

[0061] In some examples, a method of forming a valve positioning structure can include forming a support structure.

[0062] In some examples, forming the support structure can include forming a frame including a plurality of struts defining a plurality of cells therebetween.

[0063] In some examples, forming the support structure can include forming a woven or braided wire mesh structure, the wires defining a plurality of cells therebetween.

[0064] In some examples, a method can include forming a polymeric coating over at least a portion of the support structure.

[0065] In some examples, forming the polymeric coating can include forming an open-cell polymeric coating where the cells of the support structure are open.

[0066] In some examples, forming the open-cell polymeric coating can include spraycoating the support structure.

[0067] In some examples, forming the open-cell polymeric coating can include dip-coating the support structure and removing a webbing portion of the polymer coating from the cells.

[0068] In some examples, forming the open-cell polymeric coating can include engaging a blocking structure with support structure such that a plurality raised portions of the blocking structure extend into the cells of the support structure, and dip coating and / or spray coating the support structure engaged with the blocking structure.

[0069] In some examples, forming the polymeric coating can include forming a closed-cell polymeric coating where the cells of the support structure are closed by a webbing portion of the polymeric coating.THVMC-23950W001

[0070] In some examples, forming the closed-cell polymeric coating can include forming at least the webbing portion of the polymeric coating while the support structure is in an at least partially expanded state.

[0071] In some examples, forming the closed-cell polymeric coating can include placing the support structure in an at least partially expanded state.

[0072] In some examples, the support structure can be shape-set in an at least partially expanded state.

[0073] In some examples, the support structure formed to have a resting state that is an at least partially expanded state.

[0074] In some examples, the support structure can include an elastic layer disposed radially outward of its exterior surface.

[0075] In some examples, the support structure can be formed from a plastically expandable medal and can be expanded to an at least partially expanded state.

[0076] In some examples, the support structure can be shape-set in a radially collapsed state and can be mounted onto a retaining structure or a retaining device, such as a balloon or a mandrel, to retain the support structure in an at least partially radially expanded state.

[0077] In some examples, forming the closed-cell polymeric coating can include forming a first layer of polymer, forming a second layer of polymer, and fusing the first and second polymer layers.

[0078] In some examples, forming the first layer of polymer can include wrapping a sheet of polymer material over an exterior surface of a retaining device.

[0079] In some examples, forming the second layer of polymer can include dip-coating the support structure mounted on the retaining device.

[0080] In some examples, forming the second layer of polymer can include spray-coating the support structure mounted on the retaining device.

[0081] In some examples, forming the second layer of polymer can include wrapping a sheet of polymer material over an exterior surface the support structure mounted on the retaining device.

[0082] In some examples, forming the first layer of polymer can include spray-coating at least an interior surface of the support structure.

[0083] In some examples, forming the first layer of polymer can include dip-coating the support structure and removing the webbing portion from the cells.THVMC-23950W001

[0084] In some examples, forming the second layer of polymer can include dip-coating the support structure while it is mounted on the retaining device in the at least partially expanded state.

[0085] In some examples, a method can include crimping a valve positioning structure over a balloon on a distal end of the delivery apparatus.

[0086] In some examples, crimping the valve positioning structure can include simultaneously crimping a prosthetic heart valve and the valve positioning structure over the balloon.

[0087] In some examples, crimping the valve positioning structure can result in forming folds in a closed-cell polymeric coating of formed on a support structure of the valve positioning structure.

[0088] In some examples, a method can include placing a support structure of a valve positioning structure in an at least partially radially expanded state; forming a webbing portion of polymeric coating spanning across at least a portion of a plurality of cells of the support structure while the support structure is in the at least partially radially expanded state to form a closed cell polymeric coating on the support structure; mounting the valve positioning structure over a balloon of a balloon catheter; and connecting the valve positioning structure to the balloon catheter such that the valve positioning structure can radially expand and collapse upon inflation and deflation of the balloon, respectively.

[0089] In some examples, a method can include fabricating a valve positioning structure having an open-cell polymeric coating, the method comprising: forming a support structure of the valve positioning structure such that it is shape-set in a radially collapsed state, the support structure comprising a plurality of cells; and forming a polymeric coating over interior and exterior surfaces of the support structure while the support structure is in the radially collapsed state, the forming the polymeric coating resulting in a portion of the support structure being encapsulated in the polymeric coating with the cells of the support structure open.

[0090] In some examples, a method can include fabricating a valve positioning structure, wherein fabricating the valve positioning structure comprises: forming a support structure, the support structure formed from one of a plastically expandable metal or a shape-memory material shape-set in an at least partially radially expanded shape; forming a polymeric coating on the support structure in the at least partially radially expanded state; mounting theTHVMC-23950W001 valve positioning structure in the at least partially radially expanded state around a catheter balloon; and crimping the valve positioning structure from the at least partially radially expanded state to a radially compressed state around the catheter balloon.

[0091] In some examples, a delivery apparatus can include a shaft; a balloon mounted on a distal end portion of the shaft; and a valve positioning structure mounted over the balloon, the valve positioning structure comprising: a support structure comprising one of a frame or a wire mesh structure, the support structure defining a plurality of cells; and a closed-cell polymeric coating encapsulating at least a portion of the support structure, wherein a webbing portion of the closed-cell polymeric coating is configured to form one or more folds when the support structure is in a radially collapsed state and is configured to be resistant to tearing when the support structure is transitioned from the radially collapsed state to a radially expanded state.

[0092] In some examples, a delivery apparatus can include a shaft; a balloon mounted on a distal end portion of the shaft; and a valve positioning structure mounted over the balloon, the valve positioning structure comprising: a support structure comprising one of a frame or a wire mesh structure, the support structure defining a plurality of cells; and an open-cell polymeric coating encapsulating at least a portion of the support structure, wherein each of the cells is open.

[0093] In some examples, a method includes utilizing a delivery apparatus and / or system having one or more of the components recited in Examples 1-152 or 1-152 or 199-209 below and / or one or more of the steps recited in Examples 153-198 or 210-212 below.

[0094] The various innovations of this disclosure can be used in combination or separately. This summary is provided to introduce a selection of concepts in a simplified form that are further described below in the detailed description. This summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter. The foregoing and other objects, features, and advantages of the disclosure will become more apparent from the following detailed description, claims, and accompanying figures.BRIEF DESCRIPTION OF THE DRAWINGS

[0095] FIG. 1 is a side view of a prosthetic heart valve, according to one example.THVMC-23950W001

[0096] FIG. 2A is a side view of a delivery apparatus for a prosthetic heart valve, according to one example.

[0097] FIG. 2B is a side view of a distal end portion of a delivery apparatus for a prosthetic heart valve, according to another example.

[0098] FIG. 3 is a side view of a distal end portion of the delivery apparatus of FIG. 2A having valve positioning structures, according to one example, shown with a balloon in an uninflated state.

[0099] FIG. 4A is a perspective view of the distal end portion of the delivery apparatus of FIG. 3, shown with the balloon in an uninflated state and a prosthetic heart valve in a radially crimped state on the balloon.

[0100] FIG. 4B is a perspective view of the distal end portion of the delivery apparatus of FIG. 4A, shown with the balloon in an inflated state and the prosthetic heart valve in a radially expanded state.

[0101] FIG. 5A is a side view of a distal valve positioning structure comprising a frame, according to one example.

[0102] FIG. 5B is a side view of a proximal valve positioning structure comprising a frame, according to one example.

[0103] FIG. 5C is a flattened view of a frame of the valve positioning structures of FIGS. 5A- 5B, according to one example.

[0104] FIG. 6A is a side view of a distal valve positioning structure, according to one example.

[0105] FIG. 6B is a side view of a proximal valve positioning structure, according to one example.

[0106] FIG. 7A is a side view of a distal end portion of a delivery apparatus having distal and proximal valve positioning structures, according to one example, shown with a balloon in an uninflated state.

[0107] FIG. 7B is a side view of a suture connected to a proximal end portion of the distal valve positioning structure of FIG. 7A, according to one example.

[0108] FIG. 7C is a side view of a suture connected to a proximal end portion of a valve positioning structure, according to one example.THVMC-23950W001

[0109] FIG. 8A is a side view of a distal end portion of a portion delivery apparatus having a valve positioning structure, according to one example, shown with a balloon in an uninflated state.

[0110] FIG. 8B is a side view of the valve positioning structure of FIG. 8A, according to one example.

[0111] FIG. 9A is a side view of a distal end portion of a delivery apparatus having a valve positioning structure, according to one example, shown with a balloon in an uninflated state.

[0112] FIG. 9B is a side view of the distal end portion of the delivery apparatus of FIG. 9A, shown with the balloon in a partially radially expanded state.

[0113] FIG. 9C is a side view of the distal end portion of the delivery apparatus of FIGS. 9A- 9B, shown with the balloon in a radially expanded state.

[0114] FIG. 10A is a side view of a valve positioning structure, according to one example.

[0115] FIG. 10B is a flattened view of a frame of the valve positioning structure of FIG. 10A.

[0116] FIG. 10C is a side view of a distal end portion of a delivery apparatus having the valve positioning structure of FIG. 10A, shown with a balloon in an uninflated state.

[0117] FIG. 10D is a side view of the distal end portion of the delivery apparatus of FIG.10C, shown with a prosthetic valve crimped around the valve positioning structure and with the balloon in the uninflated state.

[0118] FIG. 10E is a side view of the distal end portion of the delivery apparatus of FIGS. 10C-10D, shown with the balloon a radially expanded state.

[0119] FIG. 11 is a side view of a distal end portion of a delivery apparatus, according to one example, shown with a balloon in an inflated state.

[0120] FIG. 12 is a schematic profile view of balloons for a delivery apparatus, according to one example.

[0121] FIG. 13 is a flattened view of a frame of a valve positioning structure, according to one example.

[0122] FIG. 14A is a side view of a valve positioning structure, according to one example.

[0123] FIG. 14B is a flattened view of a frame of the valve positioning structure of FIG. 14A, according to one example.

[0124] FIG. 15 is a flattened view of a frame of a valve positioning structure, according to one example.THVMC-23950W001

[0125] FIG. 16 is a flattened view of a frame of a valve positioning structure, according to one example.

[0126] FIG. 17 is a flattened view of a frame of a valve positioning structure, according to one example.

[0127] FIG. 18 is a flattened view of a frame of a valve positioning structure, according to one example.

[0128] FIG. 19 is a flattened view of a frame of a valve positioning structure, according to one example.

[0129] FIG. 20A is a side view of a distal end portion of a delivery apparatus, shown with the balloon in an uninflated state, according to one example.

[0130] FIG. 20B is a side view of the distal end portion of the delivery apparatus of FIG.20A, shown with the balloon in an inflated state, according to one example.

[0131] FIG. 20C is a flattened view of a frame of the valve positioning structure of the delivery apparatus of FIGS. 20A-20B, according to one example.

[0132] FIG. 21 is a flattened view of a frame of a valve positioning structure, according to one example.

[0133] FIG. 22 is a flattened view of a frame of a valve positioning structure, according to one example.

[0134] FIG. 23 is a flattened view of a frame of a valve positioning structure, according to one example.

[0135] FIG. 24A is a side view of a distal end portion of a delivery apparatus, shown with the balloon in an uninflated state, according to one example.

[0136] FIG. 24B is a side view of the distal end portion of the delivery apparatus of FIG.24A, shown with the balloon in an inflated state, according to one example.

[0137] FIG. 24C is a flattened view of a frame of the valve positioning structure of the delivery apparatus of FIGS. 24A-24B, according to one example.

[0138] FIG. 25 is a flattened view of a portion of a frame of a valve positioning structure, according to one example.

[0139] FIG. 26 is a flattened view of a frame of a valve positioning structure, according to one example.

[0140] FIG. 27 is a flattened view of a frame of a valve positioning structure, according to one example.THVMC-23950W001

[0141] FIG. 28 is a flattened view of a portion of a frame of a valve positioning structure, according to one example.

[0142] FIG. 29A is a side view of a distal end portion of a delivery apparatus, shown with the balloon in an uninflated state, according to one example.

[0143] FIG. 29B is a side view of the distal end portion of the delivery apparatus of FIG.29A, shown with the balloon in an inflated state, according to one example.

[0144] FIG. 29C is a flattened view of a portion of the frame of the valve positioning structure of the delivery apparatus of FIGS. 29A-29B, according to one example.

[0145] FIG. 30 is a logical flow diagram of an exemplary method for forming an open-cell polymeric coating on a valve positioning structure.

[0146] FIG. 31 is a side view of a valve positioning structure having portions thereof masked for forming a polymeric coating in an unmasked portion.

[0147] FIG. 32A is a front view of a portion of a frame where struts of the frame are encapsulated in an exemplary open-cell polymeric coating.

[0148] FIG. 32B is a cross-sectional view of one of the encapsulated struts shown in FIG. 32A.

[0149] FIG. 33 is a logical flow diagram of an exemplary method for forming a closed-cell polymeric coating on a valve positioning structure.

[0150] FIG. 34 is a cross-sectional view of valve positioning structure mounted in an at least partially expanded state on a retaining device.

[0151] FIGS. 35A-35B are cross-sectional views of an exemplary valve positioning structure including a braided mesh structure and a polymeric coating.

[0152] FIGS. 36A-36B are perspective views of a portion of the valve positioning structure of FIGS. 35A-35B in a non-compressed state and a compressed state, respectively.

[0153] FIGS. 37A-37B are front and side views of a portion of a frame valve of a valve positioning structure engaged with a blocking structure.DETAILED DESCRIPTIONGeneral Considerations

[0154] For purposes of this description, certain aspects, advantages, and novel features of examples of this disclosure are described herein. The disclosed methods, apparatus, and systems should not be construed as being limiting in any way. Instead, the present disclosureTHVMC-23950W001 is directed toward all novel and nonobvious features and aspects of the various disclosed examples, alone and in various combinations and sub-combinations with one another. The methods, apparatus, and systems are not limited to any specific aspect or feature or combination thereof, nor do the disclosed examples require that any one or more specific advantages be present or problems be solved.

[0155] Although the operations of some of the disclosed examples are described in a particular, sequential order for convenient presentation, it should be understood that this manner of description encompasses rearrangement, unless a particular ordering is required by specific language set forth below. For example, operations described sequentially may in some cases be rearranged or performed concurrently. Moreover, for the sake of simplicity, the attached figures may not show the various ways in which the disclosed methods can be used in conjunction with other methods. Additionally, the description sometimes uses terms like “provide” or “achieve” to describe the disclosed methods. These terms are high-level abstractions of the actual operations that are performed. The actual operations that correspond to these terms may vary depending on the particular implementation and are readily discernible by one of ordinary skill in the art.

[0156] As used in this application and in the claims, the singular forms “a,” “an,” and “the” include the plural forms unless the context clearly dictates otherwise. Additionally, the term “includes” means “comprises.” Further, the term “coupled” generally means physically, mechanically, chemically, magnetically, and / or electrically coupled or linked and does not exclude the presence of intermediate elements between the coupled or associated items absent specific contrary language.

[0157] As used herein, the term “proximal” refers to a position, direction, or portion of a device that is closer to the user and further away from the implantation site. As used herein, the term “distal” refers to a position, direction, or portion of a device that is further away from the user and closer to the implantation site. Thus, for example, proximal motion of a device is motion of the device away from the implantation site and toward the user (for example, out of the patient’s body), while distal motion of the device is motion of the device away from the user and toward the implantation site (for example, into the patient’s body). The terms “longitudinal” and “axial” refer to an axis extending in the proximal and distal directions, unless otherwise expressly defined.

[0158] As used herein, “e.g.” means “for example,” and “i.e.” means “that is.”THVMC-23950W001Overview of the Disclosed Technology

[0159] Described herein are examples of a delivery apparatus that can be used to navigate a subject’s vasculature to deliver an implantable, expandable medical device (for example, a prosthetic heart valve), tools, agents, or other therapy to a location within the body of a subject. Examples of procedures in which the steerable catheters are useful include neurological, urological, gynecological, fertility (for example, in vitro fertilization, artificial insemination), laparoscopic, arthroscopic, transesophageal, transvaginal, transvesical, transrectal, and procedures including access in any body duct or cavity. Particular examples include placing implants, including stents, grafts, embolic coils, and the like; positioning imaging devices and / or components thereof, including ultrasound transducers; and positioning energy sources, for example, for performing lithotripsy, RF sources, ultrasound emitters, electromagnetic sources, laser sources, thermal sources, and the like.

[0160] Prosthetic valves disclosed herein can be radially compressible and expandable between a radially compressed state and a radially expanded state. Thus, the prosthetic valves can be crimped on or retained by an implant delivery apparatus in the radially compressed state while being advanced through a patient’s vasculature on the delivery apparatus. The prosthetic valve can be expanded to the radially expanded state once the prosthetic valve reaches the implantation site. It is understood that the prosthetic valves disclosed herein may be used with a variety of implant delivery apparatuses and can be implanted via various delivery procedures, examples of which will be discussed in more detail later.

[0161] As introduced above, some prosthetic heart valves, such as the example prosthetic heart valve depicted in FIG. 1 , can be retained by a delivery apparatus in the radially compressed state and advanced through a patient’s vasculature, such as to a native heart valve, by the delivery apparatus, such as the example delivery apparatus shown in FIG. 2 A or FIG. 2B. The prosthetic valve can be expanded to the radially expanded state once the prosthetic valve reaches the implantation site, for example, by expanding a balloon of the delivery apparatus.

[0162] In some examples, the delivery apparatus can include structures that help position the prosthetic heart valve (or any other prosthetic medical device) on the distal end portion of the delivery apparatus. For example, as shown in FIGS. 3-4B, 7A, 8A, 9A-9C, 10C-11, 20A- 20B, 24A-24B, and 29A-29B, an external, expandable valve positioning structure (which isTHVMC-23950W001 also referred to herein as an external, expandable shoulder) can be coupled to an external surface of the balloon of the delivery apparatus to hold or retain the prosthetic heart valve (or any other prosthetic medical device) in an axially fixed position relative to the delivery apparatus. In some examples, the structure can be configured with a tapered surface and / or a cross-sectional size that improves the ability of the delivery apparatus to advance the prosthetic heart valve (or any other prosthetic medical device) through an introducer sheath and / or the patient’s vasculature. FIGS. 5A-5B, 6A-6B, 8B, 10A, and 14A show exemplary valve positioning structures in isolation. FIGS. 5C, 10B, 13, and 14B-19, 20C-23, 24C-28, and 29C show flattened views of exemplary frames of valve positioning structures. As a result, the devices and methods disclosed herein can, among other things, improve delivery apparatuses for prosthetic heart valves (or any other prosthetic medical device) by improving the positioning of the prosthetic heart valve (or any other prosthetic medical device) relative to the delivery apparatus and improving the ability for the delivery apparatus to advance through a patient’s vasculature.Examples of the Disclosed Technology

[0163] FIG. 1 shows a prosthetic heart valve 10 (which is also referred to herein as a “prosthetic valve”), according to one example. Any of the prosthetic valves disclosed herein are adapted to be implanted in the native aortic annulus, although in other examples they can be adapted to be implanted in the other native annuluses of the heart (the pulmonary, mitral, and tricuspid valves). The disclosed prosthetic valves also can be implanted within vessels communicating with the heart, including a pulmonary artery (for replacing the function of a diseased pulmonary valve, or the superior vena cava or the inferior vena cava (for replacing the function of a diseased tricuspid valve) or various other veins, arteries and vessels of a patient. The disclosed prosthetic valves also can be implanted within a previously implanted prosthetic valve (which can be a prosthetic surgical valve or a prosthetic transcatheter heart valve) in a valve-in-valve procedure.

[0164] In some examples, the disclosed prosthetic valves can be implanted within a docking or anchoring device that is implanted within a native heart valve or a vessel. For example, in one example, the disclosed prosthetic valves can be implanted within a docking device implanted within the pulmonary artery for replacing the function of a diseased pulmonary valve, such as disclosed in U.S. Publication No. 2017 / 0231756, which is incorporated by reference herein. In another example, the disclosed prosthetic valves can be implanted withinTHVMC-23950W001 a docking device implanted within or at the native mitral valve, such as disclosed in PCT Publication No. W02020 / 247907, which is incorporated by reference herein. In another example, the disclosed prosthetic valves can be implanted within a docking device implanted within the superior or inferior vena cava for replacing the function of a diseased tricuspid valve, such as disclosed in U.S. Publication No. 2019 / 0000615, which is incorporated by reference herein.

[0165] The prosthetic valve 10 can include a stent or frame 12, a valvular structure 14, an inner skirt 16, and a perivalvular outer sealing member or outer skirt 18. The prosthetic valve 10 can have an inflow end portion 15, an intermediate portion 17, and an outflow end portion 19. The inner skirt 16 can be arranged on and / or coupled to an inner surface of the frame 12 while the outer skirt 18 can be arranged on and / or coupled to an outer surface of the frame 12.

[0166] The valvular structure 14 can comprise three leaflets 40, collectively forming a leaflet structure, which can be arranged to collapse in a tricuspid arrangement, although in other examples there can be greater or fewer number of leaflets (for example, one or more leaflets 40). The leaflets 40 can be secured to one another at their adjacent sides to form commissures 22 of the leaflet structure 14. The lower edge of valvular structure 14 can have an undulating, curved scalloped shape and can be secured to the inner skirt 16 by sutures (not shown). In some examples, the leaflets 40 can be formed of pericardial tissue (for example, bovine pericardial tissue), biocompatible synthetic materials, or various other suitable natural or synthetic materials as known in the art and described in U.S. Patent No. 6,730,118, which is incorporated by reference herein.

[0167] The frame 12 can be radially compressible (collapsible) and expandable (for example, expanded configuration shown in FIG. 1) and comprise a plurality of interconnected struts 24. A plurality of apices 26 that are spaced circumferentially apart are formed at the inflow end portion 15 and the outflow end portion 19 of the frame 12 (only the apices 26 at the outflow end portion 19 are visible in FIG. 1). Each apex 26 is formed at a junction between two angled struts 24 at either the inflow end portion 15 or the outflow end portion 19. FIG. 1 depicts a known frame design with apices 26 that form a U-shaped bend between the two angled struts 24. In some examples, an angle 30 between the two angled struts 24, connected at the apex 26, can be in a range of 90 to 120 degrees.THVMC-23950W001

[0168] The frame 12 can be formed with a plurality of circumferentially spaced slots, or commissure windows 20 that are adapted to mount the commissures 22 of the valvular structure 14 to the frame. The frame 12 can be made of any of various suitable plastically- expandable materials (for example, stainless steel, etc.) or self-expanding materials (for example, Nitinol). When constructed of a plastically-expandable material, the frame 12 (and thus the prosthetic valve 10) can be crimped to a radially collapsed configuration on a delivery catheter or apparatus and then expanded inside a patient by an inflatable balloon or equivalent expansion mechanism. When constructed of a self-expandable material, the frame 12 (and thus the prosthetic valve 10) can be crimped to a radially collapsed configuration and restrained in the collapsed configuration by insertion into a sheath or equivalent mechanism of a delivery catheter. Once inside the body, the prosthetic valve can be advanced from the sheath, which allows the prosthetic valve to expand to its functional size.

[0169] Suitable plastically-expandable materials that can be used to form the frames disclosed herein (for example, frame 12, frame 230, etc.) include, metal alloys, polymers, or combinations thereof. Example metal alloys can comprise one or more of the following: nickel, cobalt, chromium, molybdenum, titanium, or other biocompatible metal. In some examples, the frame 12 can comprise stainless steel. In some examples, the frame 12 can comprise cobalt-chromium. In some examples, the frame 12 can comprise nickel-cobalt- chromium. In some examples, the frame 12 comprises a nickel-cobalt-chromium- molybdenum alloy, such as MP35N™ (tradename of SPS Technologies), which is equivalent to UNS R30035 (covered by ASTM F562-02). MP35N™ / UNS R30035 comprises 35% nickel, 35% cobalt, 20% chromium, and 10% molybdenum, by weight.

[0170] Any one of the skirts 16 and 18 can be wholly or partly formed of any suitable biological material, synthetic material (for example, any of various polymers), or combinations thereof. In some examples, the skirts 16 and / or 18 can comprise a fabric having interlaced yarns or fibers, such as in the form of a woven, braided, or knitted fabric. In some examples, the fabric can have a plush nap or pile. Exemplary fabrics having a plus nap or pile include velour, velvet, velveteen, corduroy, terry cloth, fleece, etc. In some examples, the skirts 16 and / or 18 can comprise a fabric without interlaced yams or fibers or randomly interlaced yams or fibers, such as felt or an electrospun fabric. Exemplary materials that can be used for forming such fabrics (with or without interlaced yarns or fibers) include, without limitation, polyethylene (PET), ultra-high molecular weight polyethyleneTHVMC-23950W001(UHMWPE), polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (ePTFE), polyamide etc. In some examples, the skirts 16 and / or 18 can comprise a non-textile or nonfabric material, such as a film made from any of a variety of polymeric materials, such as PTFE. PET, polypropylene, polyamide, polyetheretherketone (PEEK), polyurethane (such as thermoplastic polyurethane (TPU)), etc. In some examples, the skirts 16 and / or 18 can comprise a sponge material or foam, such as polyurethane foam. In some examples, the skirts 16 and / or 18 can comprise natural tissue, such as pericardium (for example, bovine pericardium, porcine pericardium, equine pericardium, or pericardium from other sources).

[0171] Additional details regarding the prosthetic valve 10 and its various components are described in WIPO Patent Application Publication No. WO 2018 / 222799, which is incorporated by reference herein.

[0172] FIG. 2A shows a delivery apparatus 100, according to an example, that can be used to implant an expandable prosthetic valve (for example, prosthetic valve 10 of FIG. 1 or any of the other prosthetic medical device described herein). In some examples, the delivery apparatus 100 is specifically adapted for use in introducing a prosthetic valve into a heart. Although the specific examples of delivery apparatuses are disclosed herein as configured for use with prosthetic heart valves (for example, the prosthetic heart valve 10 of FIG. 1 or any other prosthetic heart valve disclosed herein), the exemplary delivery apparatus can additionally or alternatively be configured for use with any other prosthetic medical device (for example, a stent, a graft, an stents, an embolic coil, and / or any other implant).

[0173] The delivery apparatus 100 in the illustrated example of FIG. 2 A is a balloon catheter comprising a handle 102 and a steerable, outer shaft 104 extending distally from the handle 102. The delivery apparatus 100 can further comprise an intermediate shaft 106 (which also may be referred to as a balloon shaft) that extends proximally from the handle 102 and distally from the handle 102, the portion extending distally from the handle 102 also extending coaxially through the outer shaft 104. Additionally, the delivery apparatus 100 can further comprise an inner shaft 108 extending distally from the handle 102 coaxially through the intermediate shaft 106 and the outer shaft 104 and proximally from the handle 102 coaxially through the intermediate shaft 106.

[0174] The outer shaft 104 and the intermediate shaft 106 can be configured to translate (for example, move) longitudinally, along a central longitudinal axis 120 of the delivery apparatusTHVMC-23950W001100, relative to one another to facilitate delivery and positioning of a prosthetic valve at an implantation site in a patient’s body.

[0175] The intermediate shaft 106 can include a proximal end portion 110 that extends proximally from a proximal end of the handle 102, to an adaptor 112. A rotatable knob 114 can be mounted on the proximal end portion 110 and can be configured to rotate the intermediate shaft 106 around the central longitudinal axis 120 and relative to the outer shaft 104.

[0176] The adaptor 112 can include a first port 138 configured to receive a guidewire therethrough and a second port 140 configured to receive fluid (for example, inflation fluid) from a fluid source. The second port 140 can be fluidly coupled to an inner lumen of the intermediate shaft 106.

[0177] The intermediate shaft 106 can further include a distal end portion that extends distally beyond a distal end of the outer shaft 104 when a distal end of the outer shaft 104 is positioned away from an inflatable balloon 118 of the delivery apparatus 100. A distal end portion of the inner shaft 108 can extend distally beyond the distal end portion of the intermediate shaft 106.

[0178] The balloon 118 can extend over the inner shaft 108. The balloon 118 can include a distal end portion 118a, an intermediate portion 118b, and a proximal portion 118c.

[0179] In some examples, the distal end portion 118a of the balloon 118 can be coupled to a distal end portion of the delivery apparatus 100, such as to a nose cone 122 (as shown in FIG. 2A), or to an alternate component at the distal end portion of the delivery apparatus 100 (for example, a distal shoulder). The proximal end portion 118c of the balloon 118 can be coupled to a distal end portion of the intermediate shaft 106. The intermediate portion 118b of the balloon 118 and the inner shaft 108 can form or define a valve mounting portion 124 of a distal end portion of the delivery apparatus 100. The distal end portion 118a of the balloon 118 can overlay a distal shoulder 126 of the delivery apparatus 100. The valve mounting portion 124 and the intermediate portion of the balloon 118 can be configured to receive a prosthetic heart valve in a radially compressed state. For example, as shown schematically in FIG. 2A, a prosthetic valve (for example, prosthetic valve 150) can be mounted around the balloon 118 at the valve mounting portion 124 of the delivery apparatus 100. The intermediate portion 118b of the balloon is alternatively be referred to herein as a valve mounting portion of the balloon 118.THVMC-23950W001

[0180] The balloon shoulder assembly, including the distal shoulder 126, is configured to maintain the prosthetic heart valve 150 (or other medical device) at a fixed position on the balloon 118 during delivery through the patient’s vasculature.

[0181] The outer shaft 104 can include a distal tip portion 128 mounted on its distal end. The outer shaft 104 and the intermediate shaft 106 can be translated axially relative to one another to position the distal tip portion 128 adjacent a proximal side of the valve mounting portion 124, when the prosthetic valve 150 is mounted in the radially compressed state on the valve mounting portion 124 (as shown in FIG. 2A) and during delivery of the prosthetic valve 150 to the target implantation site. As such, the distal tip portion 128 can be configured to resist movement of the prosthetic valve 150 relative to the balloon 118 proximally, in the axial direction, when the distal tip portion 128 is arranged adjacent a proximal side of the valve mounting portion 124.

[0182] An annular space can be defined between an outer surface of the inner shaft 108 and an inner surface of the intermediate shaft 106 and can be configured to receive fluid from a fluid source via the second port 140 of the adaptor 112. The annular space can be fluidly coupled to a fluid passageway formed between the outer surface of the distal end portion of the inner shaft 108 and an inner surface of the balloon 118. As such, fluid from the fluid source can flow to the fluid passageway from the annular space to inflate the balloon 118 (for example, from a first, deflated state to a second, radially expanded, inflated state) and radially expand and deploy the prosthetic valve 150.

[0183] An inner lumen of the intermediate shaft 106 can be configured to receive a guidewire therethrough, for navigating the distal end portion of the delivery apparatus 100 to the target implantation site.

[0184] The handle 102 can include a steering mechanism configured to adjust the curvature of the distal end portion of the delivery apparatus 100. In the illustrated example, for example, the handle 102 includes an adjustment member, such as the illustrated rotatable knob 160, which in turn is operatively coupled to the proximal end portion of a pull wire. The pull wire can extend distally from the handle 102 through the outer shaft 104 and has a distal end portion affixed to the outer shaft 104 at or near the distal end of the outer shaft 104. Rotating the knob 160 can increase or decrease the tension in the pull wire, thereby adjusting the curvature of the distal end portion of the delivery apparatus 100. Further details onTHVMC-23950W001 steering or flex mechanisms for the delivery apparatus 100 can be found in U.S. Patent No. 9,339,384, which is incorporated by reference herein.

[0185] The handle 102 can further include an adjustment mechanism 161 including an adjustment member, such as the illustrated rotatable knob 162, and an associated locking mechanism including another adjustment member, configured as a rotatable knob 178. The adjustment mechanism 161 is configured to adjust the axial position of the intermediate shaft 106 relative to the outer shaft 104 (for example, for fine positioning at the implantation site). Further details on the delivery apparatus 100 can be found in WIPO Publication No. WO2022 / 046585, which are incorporated by reference herein.

[0186] FIG. 2 A shows an example of the delivery apparatus 100 being used for “on-balloon” delivery. For such on-balloon delivery, the prosthetic valve 150 is radially compressed (or “crimped”) directly onto the valve mounting portion 124 of the delivery apparatus 100 (for example, around the intermediate portion 118b of the balloon 118) prior to insertion of the prosthetic valve 150 and the delivery apparatus 100 into a patient’s vasculature.

[0187] FIG. 2B shows an example of the delivery apparatus 100 being used for “off-balloon” delivery. For such off-balloon delivery, the prosthetic valve 150 is radially crimped offset from the valve mounting portion 124 (which is also referred to herein as an “offset position”), such as on the intermediate shaft 106 and / or on a proximal end portion of the balloon 118. The delivery apparatus 100 and the prosthetic valve 150 are inserted through an introducer sheath and into the patient’s vasculature with the prosthetic valve 150 in this offset position. Once inside the patient’s vasculature (for example, within the descending aorta), the prosthetic valve 150 can be moved from the offset position to the valve mounting portion 124 of the balloon 118. This can be accomplished by moving the intermediate shaft 106 proximally relative to the outer shaft 104 or moving the outer shaft 104 distally relative to the intermediate shaft 106 while applying a distally-directed force against a proximal end 150p of the prosthetic valve 150 with a distal end of the distal tip portion 128. In some examples, the adjustment mechanism 161 can be used to move the intermediate shaft 106 relative to the outer shaft 104 for repositioning the prosthetic valve 150. Thereafter, the delivery apparatus 100 can be further advanced to the target implantation site (for example, the native aortic annulus) and the prosthetic valve 150 can be deployed. The delivery apparatus 100 optionally can include a valve mounting member 168 positioned inside the balloon 118 alongTHVMC-23950W001 the valve mounting portion 124 to help maintain the position of the prosthetic valve 150 on the balloon 118.

[0188] FIG. 2B also shows a pull wire 166 (which can extend through a lumen of the shaft 104) having a distal end 166d that is fixed relative to a steerable section 164 of the outer shaft 104. The proximal end of the pull wire 166 can be operatively connected to the adjustment knob 160 (FIG. 2B) for adjusting the tension in the pull wire 166 for controlling the curvature of the steerable section 164 of the outer shaft 104. Further details regarding a delivery apparatus used for off-balloon delivery of a prosthetic valve are disclosed in U.S. Publication No. U.S. Publication No. 2013 / 0030519, which is incorporated by reference herein.

[0189] When the prosthetic valve 150 is retained on the valve mounting portion 124, a distal end of the prosthetic valve 150 is positioned adjacent a distal end of the valve mounting portion 124, that is, adjacent the distal shoulder 126. As such, the distal shoulder 126 can be configured to resist movement of the prosthetic valve 150 relative to the balloon 118 distally, in the axial direction, for example, when the balloon 118 is initially expanded. In some examples, as shown, the distal shoulder 126 is positioned within the balloon 118, such that the balloon 118 expands in the radially outwards direction and away from the distal shoulder 126 as the balloon 118 expands in the radially outwards direction and deploys the prosthetic heart valve 150. The distal shoulder 126 also functions to protect and shield the leading edge (in other words, the distal edge) of the prosthetic valve 150 from contacting native anatomy as the delivery apparatus 100 is advanced through the patient’s vasculature.

[0190] Additionally, during delivery of the prosthetic valve 150, the outer shaft 104 can be positioned relative to the intermediate shaft 106 such that the distal tip portion 128 is positioned adjacent a proximal end of the valve mounting portion 124 and adjacent a proximal end of the prosthetic valve 150. In some examples, the distal end of the tip portion 128 can abut the proximal end of the prosthetic valve 150. As such, in some examples, the distal tip portion 128 is also referred to herein as a “proximal shoulder.” In this position, the outer shaft 104 is disposed around and covers a portion of the balloon 118. The proximal shoulder 128 can be configured to resist movement of the prosthetic valve 150 relative to the balloon 118 proximally, in the axial direction, for example, as the delivery apparatus 100 and prosthetic valve 150 are advanced through the patient’s vasculature and / or an introducer sheath. However, prior to expanding the balloon 118, the outer shaft 104 must be retracted proximally relative to the intermediate shaft 106 to enable the balloon 118 to be fully inflatedTHVMC-23950W001(for example, without interference with the outer shaft 104). This is due in part to the outer shaft 104 and / or the proximal shoulder 128 not being expandable when the balloon 118 is radially expanded. Also, as noted above, for off-balloon delivery, the distal tip portion 128 of the outer shaft 104 can be used to push the prosthetic valve 150 onto the valve mounting portion 124 once the prosthetic valve 150 and the distal end portion of the delivery apparatus 100 are inserted into the patient’s vasculature.

[0191] Structures positioned inside of a balloon, such as the distal shoulder 126, while effective, involve relatively complex manufacturing steps. For example, once the balloon 118 has been formed or shaped, it can be difficult to insert the distal shoulder 126 inside the balloon 118.

[0192] Moreover, when deploying the prosthetic valve 150, the prosthetic valve 150 desirably is positioned to be substantially coaxial with the annulus of the native heart valve so that the prosthetic valve 150 can be evenly expanded and securely anchored within the annulus. In some circumstances, despite the initial position of the prosthetic valve 150 being coaxial with the native annulus, such coaxiality may be disturbed or lost after retracting the outer shaft 104 off the balloon 118 just prior to balloon inflation. This can occur if the steerable section 164 of the outer shaft 104 is retained in a curved state via increased tension in the pull wire (for example, pull wire 166) while the outer shaft 104 is retracted. Retracting the outer shaft 104 retracts the steerable section 164 farther away from the balloon 118 and the prosthetic valve 150. Without the structural support of the steerable section 164, the distal end portion of the intermediate shaft 106 and the distal end portion of the inner shaft 108 (where the balloon 118 and the prosthetic valve 150 are mounted) may deflect slightly relative to the steerable section 164. As a result, the prosthetic valve 150 may no longer be coaxial with the native annulus.

[0193] Thus, in some examples, it may be desirable for structures that help maintain the axial position of a prosthetic valve (for example, prosthetic valve 10, prosthetic valve 150) relative to a delivery apparatus (for example, delivery apparatus 100) to be disposed around a balloon (for example, balloon 118) of the delivery apparatus to facilitate insertion of the prosthetic valve through a patient’s vasculature and an introducer sheath, improve the positioning of the prosthetic valve relative to the balloon during delivery, and do so without requiring translation of an outer shaft (for example, outer shaft 104) prior to inflating the balloon, among other things. For example, these structures can be configured to expand as the balloonTHVMC-23950W001 expands, and in some examples, these structures can help maintain the position of the prosthetic valve relative to the delivery apparatus during radial expansion of the prosthetic valve. In some examples, these structures can be used in lieu of a distal shoulder (for example, distal shoulder 126) and / or a proximal shoulder (for example, proximal shoulder 128).

[0194] FIG. 3 illustrates the valve mounting portion 124 of the distal end portion of the delivery apparatus 100, according to another example. The delivery apparatus 100 of FIG. 3 includes an expandable, external distal valve positioning structure 226 (also referred to herein as a “distal shoulder”) and an expandable, external proximal valve positioning structure 228 (also referred to herein as a “proximal shoulder”). The distal valve positioning structure 226 extends at least partially over the distal portion 118a of the balloon 118 and the proximal valve positioning structure 228 extends at least partially over the proximal portion 118c of the balloon 118.

[0195] Although the valve positioning structures 226, 228 are shown to extend over portions of the outer surface of the balloon 118, in some examples, the valve positioning structures 226, 228 are not adhered, fixed, or otherwise attached to the outer surface of the balloon 118. It should be understood that, similarly, any other valve positioning structure herein need not be adhered, fixed, fastened, or otherwise attached to the outer surface of the balloon 118. For example, the valve positioning structures 226, 228 can contact the outer surface of the balloon 118, but the valve positioning structures 226, 228 are not adhered, fixed, fastened, or otherwise attached to the outer surface of the balloon 118, such that the valve positioning structures 226, 228 can freely move relative to the outer surface as the balloon 118 is inflated. In some examples, the valve positioning structures 226, 228 (or other valve positioning structures disclosed herein) can be adhered, fixed, or otherwise attached to the outer surface of the balloon. In the example of FIG. 3, the internal distal shoulder 126 can be excluded. Similarly, it should be understood that any delivery apparatus or delivery system disclosed herein can lack the internal distal shoulder 126.

[0196] In some examples, any one of the valve positioning structures disclosed herein or any portion(s) thereof can comprise a super-elastic and / or shape-memory material and can be shape set in a radially collapsed configuration (which is also referred to herein as a “radially collapsed state,” “radially compressed state,” and / or “radially compressed configuration”), such that the valve positioning structure can expand to a radially expanded configurationTHVMC-23950W001(which is also referred to herein as a “radially expanded state”) upon inflation of the balloon 118 and return to the radially collapsed configuration when the balloon is deflated, as further described below. For example, any one of the disclosed valve positioning structures can be made of Nitinol.

[0197] As shown, the distal valve positioning structure 226 comprises an annular frame 230, which is further described with reference to FIG. 5C. The distal valve positioning structure 226 can be coupled at its distal end to the nose cone 122. In some examples, the distal valve positioning structure 226 can have an outer diameter that is greater than an outer diameter of the prosthetic valve 150 in its radially compressed state, as shown in FIG. 4A. In this way, the outer profile of the distal valve positioning structure 226 enables the delivery apparatus 100 to be more easily advanced through an introducer sheath and / or a patient’s vasculature in a manner that protects against undesirable contact between the leading edge (the distal end) of the prosthetic valve 150 and the patient’s vasculature and between the leading edge of the prosthetic valve 150 and an inner surface of the introducer sheath. In some examples, the greater outer diameter of the distal valve positioning structure 226 relative to the outer diameter of the prosthetic heart valve 150 can help pre-dilate the introducer sheath ahead of the prosthetic valve 150 as the prosthetic valve (mounted on the delivery apparatus) is inserted into the sheath. In some examples, the greater outer diameter of the distal valve positioning structure 226 relative to the outer diameter of the prosthetic heart valve 150 can help further minimize migration of the prosthetic heart valve 150 relative to the balloon 118 (for example, distal migration) during inflation of the balloon. These advantages can also be realized with any of the other examples of distal valve positioning structures and distal valve positioning portions disclosed herein that include an outer diameter that is greater than the outer diameter of the radially compressed prosthetic valve.

[0198] Similarly, the proximal valve positioning structure 228 can comprise the frame 230. As shown, the proximal end of the proximal valve positioning structure 228 is coupled to the intermediate shaft 106. The proximal valve positioning structure 228 can be configured to counteract proximally-directed forces applied by the prosthetic valve 150 during delivery of the prosthetic valve 150 (for example, through an introducer sheath and / or a patient’s vasculature), thereby maintaining the positioning of the prosthetic valve 150 on the balloon 118 as it is advanced through an introducer sheath and the patient’s vasculature.THVMC-23950W001

[0199] In some examples, the frame 230 of the proximal valve positioning structure 228 and the frame 230 of the distal valve positioning structure 226 can be the same frame 230 shape set in different configurations. For example, the frame 230 can be shape set in a distal configuration to form the distal valve positioning structure 226, and the frame 230 can be shape set in a proximal configuration to form the proximal valve positioning structure 228. In some examples, the distal valve positioning structure 226 and the proximal valve positioning structure 228 can comprise the same frame 230 shape set in the same configuration, such that the proximal valve positioning structure 228 and the distal valve positioning structure 226 are interchangeable.

[0200] The frame 230 (and any other frame disclosed herein) can be a unitary and / or fastener- free structure that can be formed from a single piece of material (for example, Nitinol), such as in the form of a tube. The frame 230 can comprise a plurality of struts arranged to form a plurality of cells. The plurality of struts and cells can be formed by removing portions (for example, via laser cutting) of the single piece of material.

[0201] Referring now to FIG. 4A, the prosthetic valve 150 can be radially compressed around the intermediate portion 118b of the balloon 118 between the distal valve positioning structure 226 and the proximal valve positioning structure 228 for delivery through the patient’s vasculature. As the distal end portion of the delivery apparatus 100 and the compressed prosthetic valve 150 are advanced through an introducer sheath and / or the patient’s vasculature, the distal valve positioning structure 226 and the proximal valve positioning structure 228 resist or prevent axial movement of the prosthetic valve 150 relative to the balloon 118 (for example, distal migration), and thereby maintain the prosthetic valve 150 at its desired location on the balloon 118 until deployment.

[0202] As shown in FIG. 4A, the valve positioning structures 226, 228 are sized such that there can be gaps between the distal end of the prosthetic valve 150 and the adjacent proximal end of the distal valve positioning structure 226 and between the proximal end of the prosthetic valve 150 and the adjacent distal end of the proximal valve positioning structure 228. The presence of these gaps can facilitate radial expansion of the prosthetic valve 150 without interference from the valve positioning structures 226, 228 upon inflation of the balloon 118.

[0203] In some examples, one of or both the valve positioning structures 226, 228 can be sized such that the distal end of the prosthetic valve 150 abuts the adjacent proximal end ofTHVMC-23950W001 the distal valve positioning structure 226 and / or the proximal end of the prosthetic valve 150 abuts the adjacent distal end of the proximal valve positioning structure 228 when the prosthetic valve 150 is radially compressed around the intermediate portion 118b of the balloon 118. Thus, neither the distal valve positioning structure 226 nor the proximal valve positioning structure 228 overlap or extend over an outer surface of the prosthetic valve 150 when the prosthetic valve 150 is crimped onto the balloon 118.

[0204] In some examples, at least one of the distal valve positioning structure 226 and the proximal valve positioning structure 228 can at least partially overlap at least part of the prosthetic heart valve 150 or vice versa. For example, at least one or both of the distal valve positioning structure 226 and the proximal valve positioning structure 228 can be shape set such that the prosthetic heart valve 150 can be crimped over at least an adjacent end portion of at least one of the distal valve positioning structure 226 and the proximal valve positioning structure 228 with an intermediate portion of the prosthetic valve between the opposing end portions in contact with the balloon (that is, a distal end portion of the prosthetic valve can overlap an adjacent end portion of the distal valve positioning structure 226 and / or a proximal end portion of the prosthetic valve can overlap an adjacent end portion of the proximal valve positioning structure 228).

[0205] As shown in FIG. 4B, when the balloon 118 is inflated to radially expand the prosthetic valve 150, the valve positioning structures 226, 228 can radially expand under the force of the balloon 118 from their radially collapsed state (FIG. 4A) to a radially expanded state (FIG. 4B). As noted above, the valve positioning structures 226, 228 can be shape set in the radially collapsed state. Thus, when the balloon 118 is deflated after expanding the prosthetic valve 150, the valve positioning structures 226, 228 can revert to the radially collapsed state of FIG. 4A under their own resiliency, which in some examples can beneficially facilitate the retrieval of the delivery apparatus 100 from the patient’s vasculature. As used herein and throughout this disclosure, the term “resiliency” refers to the ability of a structure to deform to a deformed shape or state in response to an external force and elastically return to a default or relaxed shape or state after the external force is removed. It should be understood that any valve positioning structure disclosed herein can revert back to a radially collapsed or compressed state under its own resiliency.

[0206] While both valve positioning structures 226, 228 are present in the example of FIGS.3-4B, in some examples, one of the valve positioning structures 226, 228 can be omitted. ForTHVMC-23950W001 example, the delivery apparatus 100 can include the distal valve positioning structure 226 but not the proximal valve positioning structure 228. In some examples, the delivery apparatus 100 can include the proximal valve positioning structure 228 but not the distal valve positioning structure 226.

[0207] When both valve positioning structures 226, 228 are present, the prosthetic valve 150 can be initially radially compressed on the valve mounting portion 124 of the balloon 118 for performing an on-balloon delivery procedure. When only one valve positioning structure (for example, the distal valve positioning structure 226) is present, the prosthetic valve 150 can be crimped offset the valve mounting portion 124 of the balloon 118 for performing an off- balloon delivery procedure.

[0208] FIG. 5A is a side view of the distal valve positioning structure 226 in the radially collapsed state. FIG. 5B is a side view of the proximal valve positioning structure 228 in the radially collapsed state. Each one of the distal valve positioning structure 226 and the proximal valve positioning structure 228 can comprise the frame 230, which is best illustrated in a flattened configuration in FIG. 5C. In some examples, the frame 230 can be shape set in a first configuration (a “distal configuration’') to form the distal valve positioning structure 226 or shape set in a second configuration (a “proximal configuration”) to form the proximal valve positioning structure 228. In some examples, the frame 230 of the distal valve positioning structure 226 can have the shape shown in FIG. 5B and the frame 230 of the proximal valve positioning structure 228 can have the shape shown in FIG. 5A. In some examples, each of the distal valve positioning structure 226 and the proximal valve positioning structure 228 can comprise the frame 230 shape set in the same configuration, such that the distal valve positioning structure 226 and the proximal valve positioning structure 228 are interchangeable. In some examples, using a standard frame (for example, frame 230) for the distal valve positioning structure 226 and the proximal valve positioning structure 228 can beneficially decrease the number of unique parts needed to manufacture the delivery apparatus 100 and / or increase interchangeability among the parts of the delivery apparatus 100.

[0209] Now referring to FIG. 5C, the frame 230 can comprise a plurality of struts that includes a first plurality of struts 232, a second plurality of struts 234, a third plurality of struts 236, a fourth plurality of struts 238, a fifth plurality of struts 240, and a sixth plurality of struts 242. The first plurality of struts 232 (which are also referred to herein as a “pluralityTHVMC-23950W001 of angled linear stmts,” a “plurality of angled stmts,” and / or a “plurality of linear stmts”) can be arranged into a first row 244 that extends in a circumferential direction of the frame 230. Each one of the first plurality of stmts 232 can be oriented at an angle relative to an axial direction of the frame 230. Each one of the first plurality of stmts 232 can comprise a distal end and a proximal end. The distal ends of adjacent ones of the first plurality of stmts 232 can be connected at curved or rounded distal apices 256 that define a distal end of the frame 230. The proximal ends of adjacent ones of the first plurality of stmts 232 can be connected at junctions 258 (which are also referred to herein as “unions”).

[0210] The second plurality of stmts 234 (which are also referred to herein as a “plurality of angled linear stmts,” a “plurality of angled stmts,” and / or a “plurality of linear stmts”) can be arranged in a second row 246 that extends in the circumferential direction of the frame 230 and is proximally disposed relative to the first row 244. Each one of the second plurality of stmts 234 can be oriented at an angle relative to the axial direction of the frame 230. Each one of the second plurality of stmts 234 can comprise a distal end and a proximal end. The distal ends of adjacent ones of the second plurality of stmts 234 can be connected at the junctions 258. The proximal ends of adjacent ones of the second plurality of stmts 234 can be connected at junctions 260 (which are also referred to herein as “unions”).

[0211] The third plurality of stmts 236 (which are also referred to herein as a “plurality of angled linear struts,” a “plurality of angled struts,” and / or a “plurality of linear struts”) can be arranged in a third row 248 that extends in the circumferential direction of the frame 230 and is proximally disposed relative to the second row 246. Each one of the third plurality of stmts 236 can be oriented at an angle relative to the axial direction of the frame 230. Each one of the third plurality of stmts 236 can comprise a distal end and a proximal end. The distal ends of adjacent ones of the third plurality of struts 236 can be connected at junctions 260. The proximal ends of adjacent ones of the third plurality of stmts 236 can be connected at junctions 262 (which are also referred to herein as “unions”).

[0212] The fourth plurality of stmts 238 (which are also referred to herein as a “plurality of angled linear struts,” a “plurality of angled struts,” and / or a “plurality of linear struts”) can be arranged in a fourth row 250 that extends in the circumferential direction of the frame 230 and is proximally disposed relative to the third row 248. Each one of the fourth plurality of stmts 238 can be oriented at an angle relative to the axial direction of the frame 230. Each one of the fourth plurality of stmts 238 can comprise a distal end and a proximal end. TheTHVMC-23950W001 distal ends of adjacent ones of the fourth plurality of struts 238 can be connected at junctions 262. The proximal ends of adjacent ones of the fourth plurality of struts 238 can be connected at junctions 264 (which are also referred to herein as “unions”).

[0213] The fifth plurality of struts 240 (which are also referred to herein as a “plurality of angled linear struts,” a “plurality of angled struts,” and / or a “plurality of linear struts”) can be arranged in a fifth row 252 that extends in the circumferential direction of the frame 230 and is proximally disposed relative to the fourth row 250. Each one of the fifth plurality of struts 240 can be oriented at an angle relative to the axial direction of the frame 230. Each one of the fifth plurality of struts 240 can comprise a distal end and a proximal end. The distal ends of adjacent ones of the fifth plurality of struts 240 can be connected at junctions 264. The proximal ends of adjacent ones of the fifth plurality of struts 240 can be connected at junctions 266 (which are also referred to herein as “unions”).

[0214] The sixth plurality of struts 242 (which are also referred to herein as a “plurality of angled linear struts,” a “plurality of angled struts,” and / or a “plurality of linear struts”) can be arranged in a sixth row 254 that extends in the circumferential direction of the frame 230 and is proximally disposed relative to the fifth row 252. Each one of the sixth plurality of struts 242 can be oriented at an angle relative to the axial direction of the frame 230. Each one of the sixth plurality of struts 242 can comprise a distal end and a proximal end. The distal ends of adjacent ones of the sixth plurality of struts 242 can be connected at junctions 266. The proximal ends of adjacent ones of the sixth plurality of struts 242 can be connected at curved or rounded proximal apices 268 that define a proximal end of the frame 230.

[0215] The struts of the frame 230 can be arranged and / or connected to form a plurality of cells. For example, the first and second pluralities of struts 232, 234 can connect to each other to form a first circumferentially-extending row of cells 270. Similarly, the third and fourth pluralities of struts 236, 238 can be connected to each other to form a second row of cells 272. Similar, the fifth and six pluralities of struts 240, 242 can be connected to each other to form a third row of cells 274. Although the illustrated frame 230 includes three rows of cells 270, 272, 274, other examples of the frame 230 can include one, two, four, five, six, etc. rows of cells.

[0216] As shown in FIG. 5C, each cell of the frame 230 has a diamond shape. However, in some examples, the struts of the frame 230 can be arranged to form cells with different shapes (for example, circles, triangles, squares, rectangles, pentagons, hexagons, heptagons,THVMC-23950W001 octagons, etc.).

[0217] As shown in FIG. 5A, the frame 230 in its shape set state can include a cylindrical portion formed by the cells 274, a flared region formed by the cells 272 that increases in diameter in a direction extending away from the cells 274, and a tapered region formed by the cells 270 that decreases in diameter in a direction extending away from the cells 272. When used as the frame for the distal valve positioning structure 226, the cylindrical portion (or at least the apices 268) can be fixed to the nose cone 122 or another component of the delivery apparatus. When used as the frame for the proximal valve positioning structure 228, the cylindrical portion (or at least the apices 268) can be fixed to the intermediate shaft 106 or another component of the delivery apparatus (for example, the outer shaft 104).

[0218] As shown in FIG. 5B, the frame 230 in its shape set state can include a constant taper or decrease in diameter along its length from one end to the other end. When used as the frame for the proximal valve positioning structure 228, the frame tapers in a distal-to- proximal direction and the smaller diameter end portion (or at least the apices 268) can be fixed to the intermediate shaft 106 or another component of the delivery apparatus (for example, the outer shaft 104). When used as the frame for the distal valve positioning structure 226, the frame 230 tapers in a proximal-to-distal direction and the smaller diameter end portion (or at least the apices 268) can be fixed to the nose cone 122 or another component of the delivery apparatus.

[0219] The valve positioning structures 226, 228 can be fixed to nose cone 122 and the intermediate shaft 106, respectively, (or to other components of the delivery apparatus) with an adhesive and / or by reflowing the polymer material forming the nose cone 122 and the intermediate shaft 106 such that the polymer material bonds to or encases an adjacent portion of the valve positioning structures 226, 228. In some examples, the valve positioning structures 226, 228 are not physically fixed or attached to the balloon 118 to facilitate inflation of the balloon 118. Typically, in its uninflated state, the balloon 118 is folded to form axially extending pleats or folds to minimize the crimp profile of the balloon 118. By not connecting the balloon 118 directly to the valve positioning structures 226, 228, the balloon 118 can unfold and inflate as an inflation fluid is introduced into the balloon 118.

[0220] Now referring to FIGS. 6A and 6B, there is shown an expandable, external distal valve positioning structure 326 and an expandable, external proximal valve positioning structure 328, respectively, according to one example. The valve positioning structures 326,THVMC-23950W001328 can each comprise the frame 230. One exemplary difference between the valve positioning structures 326, 328 and the valve positioning structures 226, 228 shown in FIGS. 5A-5B is that each of the valve positioning structures 326, 328 further comprises a polymeric coating 275 (which is also referred to herein as a “polymeric cover,” a “coating,” and / or a “cover”) disposed on at least one of an inner surface and an outer surface of the frame 230. The polymeric coating 275 can be formed from any suitable polymer, such any of various synthetic elastomers, such as polyurethane, (for example, Tecoflex™ or NueSoft™), styrene ethylene butylene styrene (SEBS), styrene butadiene styrene (SBS), styrene isoprene styrene (SIS), silicone, silicone-polyurethane blends, or thermoplastic vulcanizate (TPV) (for example, Santoprene). In some examples, the polymeric coating 275 can provide an atraumatic finish that further minimizes potentially traumatic contact with the tissue of the subject’s vasculature.

[0221] In some examples, the polymeric coating 275 can form a liner or layer of material on the inner surface of the frame 230, the outer surface of the frame 230, or both the inner surface and outer surface of the frame 230. In some examples, the frame 230 is encapsulated within the polymeric coating 275. Various techniques (for example, reflow of material extrusions and / or lamination) can be used to form the polymeric coating 275, such as, for example, by dipping the frame 230 into the material that forms the polymeric coating 275 when the polymeric coating 275 is in a liquified state. Although the polymeric coating 275 is only shown with reference to FIGS. 6 A and 6B, it should be understood that any valve positioning structure disclosed herein can include a polymeric coating (on the inner surface and / or the outer surface of the frame of the valve positioning structure) that shares certain similarities with the polymeric coating 275. Additional examples of polymeric coatings and methods of forming polymeric coatings on a frame (for example, methods of forming the polymeric coating 275 formed on the frame 230 and / or other valve positioning structures disclosed herein, and methods of forming other types of polymeric coatings on the valve positioning structures herein) are discussed below with reference to FIGS. 30-36B.

[0222] Now referring to FIG. 7A, there is shown a distal end portion of a delivery apparatus 200, according to one example. One exemplary difference between the delivery apparatus 200 and the delivery apparatus 100 shown in FIGS. 4A-4B is that the delivery apparatus 200 includes at least one suture 276 (for example, a plurality of sutures) connected to the distal valve positioning structure 226. In some examples, the suture 276 (which are also referred toTHVMC-23950W001 herein as “tethers” and / or “cords”) can extend distally from a proximal end portion of the delivery apparatus 200 (for example, from the handle 102), through the lumen of the intermediate shaft 106, along the outer surface of the balloon 118, and connect to a portion of the distal valve positioning structure 226 (for example, the frame 230 of the distal valve positioning structure 226).

[0223] The at least one suture 276 can be connected to the frame 230 of the distal valve mounting portion 226 using loops, knots, mechanical fasteners, adhesives, etc. For example, as shown in FIG. 7B, an intermediate portion of the suture 276 can be looped around an apex (for example, one of the proximal apices 268 shown in FIG. 5C) of the frame 230. Alternatively, as best shown in FIG. 7C, a distal end of the suture 276 can terminate in a loop 280 that can be secured to a portion of the frame 230 (for example, one of the proximal apices 268 shown in FIG. 5C). In some examples, there can be one suture 276 looped around or otherwise connected to each apex 268.

[0224] In some examples, the at least one suture 276 can be connected to an adjustment member for adjusting tension in the suture 276. For example, the suture 276 can be connected to a rotatable knob coupled to the handle 102 of the delivery apparatus 200. The user can rotate the knob to vary the tension in the suture 276. As noted above, after the prosthetic valve (for example, prosthetic valve 10 or prosthetic valve 150) is deployed and the inflation fluid is removed from the balloon 118, the distal valve positioning structure 226 reverts to its radially compressed state. Tensioning the sutures 276 can further reduce the diameter of the proximal end of the distal valve positioning structure 226 so that the delivery apparatus 200 can be more easily retracted back through an introducer sheath when being removed from the patient’s body.

[0225] Now referring to FIG. 8A, there is shown a distal end portion of a delivery apparatus 300, according to another example. The illustrated portion of the delivery apparatus 300 includes the intermediate shaft 106, the nose cone 122 distally disposed relative to the intermediate shaft 106, a balloon (such as balloon 118) disposed between the intermediate shaft 106 and the nose cone 122, and the prosthetic valve 150 crimped around the distal end portion of the delivery apparatus 300. One exemplary difference between the delivery apparatus 300 and the previously illustrated delivery apparatuses is that the delivery apparatus 300 includes an expandable, external valve positioning structure 325 that replaces the function of separate distal and proximal valve structures 226, 228. The valve positioningTHVMC-23950W001 structure 325 extends along an axial length of the balloon). In some examples, the valve positioning structure 325 can extend over the entire axial length of the balloon or substantially (within 10%) the entire axial length of the balloon. The valve positioning structure 325 can be disposed around the balloon of the delivery apparatus 300 and / or coupled to an external surface of the balloon. Desirably, the valve positioning structure 325 is not directly physically attached to the balloon to allow the pleats of the balloon to move relative to the valve positioning structure 325 and unfold as the balloon is inflated. The valve positioning structure 325 can be fixed at its distal end to the nose cone 122. The valve positioning structure 325 can be fixed at its proximal end to the distal end portion of the intermediate shaft 106 (for example, an inner surface of the intermediate shaft 106 or an outer surface of the intermediate shaft 106). The prosthetic valve 150 can be mounted or crimped around an intermediate portion of the valve positioning structure 325.

[0226] The valve positioning structure 325 can include a frame 330 defining a distal valve positioning portion 326, a proximal valve positioning portion 328 disposed proximally relative to the distal valve positioning portion 326, and an intermediate valve positioning portion 329 disposed between the distal valve positioning portion 326 and the proximal valve positioning portion 328. The valve positioning structure 325 can be configured such that the intermediate valve positioning portion 329 aligns in an axial direction of the delivery apparatus 300 with the valve mounting portion 124 and / or the intermediate portion 118b of the balloon 118. Thus, when the prosthetic valve 150 is crimped around the delivery apparatus 300, the prosthetic valve 150 can be crimped around the intermediate valve positioning portion 329 and between the distal valve positioning portion 326 and the proximal valve positioning portion 328.

[0227] In some examples, when the prosthetic valve 150 is crimped around the intermediate valve positioning portion 329, none of the distal valve positioning portion 326, the proximal valve positioning portion 328, or the intermediate valve positioning portion 329 overlap the outer surface of the prosthetic valve 150. Furthermore, in some examples, when the prosthetic valve 150 is crimped around the intermediate valve positioning portion 329, no portion of the prosthetic valve 150 touches the outer surface of the balloon 118. In other words, the intermediate valve positioning portion 329 (as well as all other intermediate valve positioning portions disclosed herein) can prevent contact between the prosthetic valve 150 and the outer surface of the balloon 118.THVMC-23950W001

[0228] In some examples, the distal valve positioning portion 326 can have an outer diameter that is greater than an outer diameter of each of the intermediate valve positioning portion 329 and the prosthetic valve 150 in its radially compressed state, as shown in FIG. 8 A. In this way, the outer profile of the distal valve positioning portion 326 enables the delivery apparatus 300 to be more easily advanced through an introducer sheath and / or a patient’ s vasculature in a manner that protects against undesirable contact between the leading edge (the distal end) of the prosthetic valve 150 and the patient’s vasculature and between the leading edge of the prosthetic valve 150 and an inner surface of the introducer sheath.

[0229] In some examples, when the valve positioning structure 325 is in a radially collapsed state, each of the distal valve positioning structure 326 and the proximal valve positioning structure 328 can have an outer diameter that is greater than the outer diameter of each of the intermediate valve positioning portion 329 and the prosthetic valve 150 in its radially compressed state. In this way, the distal and proximal valve positioning portions 326, 328 can be configured to counteract distally- and proximally-directed forces applied by the prosthetic valve 150 during delivery of the prosthetic valve 150, thereby maintaining the positioning of the prosthetic valve 150 on the balloon 118 as it is advanced through an introducer sheath and the patient’ s vasculature.

[0230] Now referring to FIG. 8B, the distal valve positioning portion 326, the proximal valve positioning portion 328, and the intermediate valve positioning portion 329 can be connected to form the frame 330, which can comprise a plurality of struts arranged into a plurality of cells. In some examples, the frame 330 can be a unitary and / or fastener-free structure. In some examples, the distal valve positioning portion 326, the proximal valve positioning portion 328, and the intermediate valve positioning portion 329 can be formed from a single piece of material (for example, Nitinol), such as in the form of a tube. In such an example, the valve positioning structure 325 and / or the frame 330 can be formed by removing portions (for example, via laser cutting) of the single piece of material.

[0231] The frame 330 of the valve positioning structure 325 (and all other frames of valve positioning structures disclosed herein) can be made of a shape memory material, such as Nitinol. When made of such a shape memory material, the frame 330 (and all other frames disclosed here) can be shape set in the radially collapsed state (FIGS. 8A and 8B), and can radially expand to a radially expanded state under the force of the inflating balloon and thenTHVMC-23950W001 radially collapse back to the radially collapsed state under its own resiliency when the balloon is deflated.

[0232] Another advantage of the valve positioning structure 325 (and other valve positioning structures disclosed herein) is that the frame 330, when made of a metal (such as Ninitol), the frame 330 is visible under fluoroscopy and therefore the frame 330 (or portions thereof) can be used as positioning or alignment device for positioning the prosthetic valve relative to the intended implantation site. Thus, in some examples, the balloon can be inflated with a clear inflation fluid (such as saline) without a contrast solution, which typically is used in valve implantation procedures to make the balloon visible under fluoroscopy. In some examples, the use of a clear inflation fluid (which in some examples can be less allergenic than contrast solution) to inflate the balloon can further reduce the likelihood of potential complications (for example, allergic reactions to contrast solution) if the balloon bursts or leaks during the implantation process.

[0233] FIGS. 9A-9C illustrate a distal end portion of a delivery apparatus 400 during different stages of a prosthetic valve implantation procedure, according to one example. Now referring to FIG. 9A, there is shown the delivery apparatus 400 before the prosthetic valve 150 is mounted or crimped around the distal end portion of the delivery apparatus 400. The delivery apparatus 400 can include the intermediate shaft 106, the nose cone 122 disposed distally relative to the intermediate shaft 106, and the balloon 118 (FIGS. 9B-9C) in a deflated state. One exemplary difference between the delivery apparatus 400 and the delivery apparatus 300 of FIGS. 8A-8B is that the delivery apparatus 400 includes an expandable, external valve positioning structure 425.

[0234] The valve positioning structure 425 can include a distal valve positioning portion 426, a proximal valve positioning portion 428 proximally disposed relative to the distal valve positioning portion 426, and an intermediate valve positioning portion 429 disposed between the distal valve positioning portion 426 and the proximal valve positioning portion 428. As shown, an outer diameter of each of the distal valve positioning portion 426 and the proximal valve positioning portion 428 is larger than an outer diameter of the intermediate valve positioning portion 429 when the valve positioning structure 425 is in a radially collapsed state.

[0235] One exemplary difference between the valve positioning structure 425 and the valve positioning structure 325 shown in FIGS. 8A-8B is that the illustrated valve positioningTHVMC-23950W001 structure 425 comprises a braided (or woven) mesh structure 430. In some examples, the braided mesh structure 430 can be formed by braiding one or more wires (for example, Nitinol wires and / or polymer-coated Nitinol wires). The braided mesh structure 430 is shape set in a radially collapsed state (FIG. 9A) and is configured to radially expand to a radially expanded state (FIG. 9C) as the balloon is inflated. As the inflation fluid is removed from the balloon, the braided mesh structure 430 can return to the radially collapsed state under its own resiliency.

[0236] Now referring to FIG. 9B, there is shown the distal end portion of the delivery apparatus 400, wherein the balloon 118, the prosthetic valve 150, and the valve positioning structure 425 are each in a partially radially expanded state (which is also referred to herein as a “partially radially collapsed state” and / or “partially radially compressed state”) between the radially compressed state and the radially expanded state. As shown, the outer diameter of each of the distal valve positioning portion 426 and the proximal valve positioning portion 428 is larger than the outer diameter of the intermediate valve positioning portion 429 when the valve positioning structure 425 is in the partially radially expanded state. In this way, the valve mounting structure 425 can help keep the prosthetic valve 150 aligned in an axial direction of the delivery apparatus 400 with the valve mounting portion 124 as the balloon 118 is inflated. When the prosthetic valve 150 is crimped around the intermediate valve positioning portion 429 and when the balloon 118 is partially radially expanded, none of the distal valve positioning portion 426, the proximal valve positioning portion 428, or the intermediate valve positioning portion 429 overlap the outer surface of the prosthetic valve 150.

[0237] Now referring to FIG. 9C, there is shown the distal end portion of the delivery apparatus 400, wherein the balloon 118, the prosthetic valve 150, and the valve positioning structure 425 are each in the radially expanded state. As shown, the outer diameter of each of the distal valve positioning portion 426 and the proximal valve positioning portion 428 is substantially the same as the outer diameter of the intermediate valve positioning portion 429 when the valve positioning structure 425 is in the radially expanded state. For example, the outer diameter of each of the distal valve positioning portion 426 and the proximal valve positioning portion 428 can be within 10% of the outer diameter of the intermediate valve positioning portion 429 when the valve positioning structure 425 is in the radially expanded state. In this way, the prosthetic valve 150 can be uniformly expanded along its axial lengthTHVMC-23950W001 by the expansion of the balloon 118 and / or the valve positioning structure 425. In some examples, the uniform expansion of the balloon 118 and / or the valve positioning structure 425 can help minimize and / or prevent axial migration (for example, distal migration) of the prosthetic valve 150.

[0238] FIGS. 10A-10E illustrate an expandable, external valve positioning structure 525, according to one example. Now referring to FIG. 10A, the valve positioning structure 525 — shown in a radially collapsed state — comprises a frame 530 defining a distal valve positioning portion 526, a proximal valve positioning portion 528 proximally disposed relative to the distal valve positioning portion 526, and an intermediate valve positioning portion 529 disposed between the distal valve positioning portion 526 and the proximal valve positioning portion 528.

[0239] In some examples, the distal valve positioning portion 526 can have a tapered shape. For example, as shown in FIG. 10A, the distal end portion of the distal valve positioning portion 526 defines a first diameter DI and the proximal end portion of the distal valve positioning portion 526 defines a second diameter D2. As shown, D2 can be greater than DI such that the distal valve positioning portion 526 tapers towards the distal end portion of the valve positioning structure 525. Such a configuration can result in the distal valve positioning portion 526 having a frustoconical shape that tapers to towards the distal end portion of the valve positioning structure 525.

[0240] The proximal valve positioning portion 528 can have a tapered shape. For example, as shown, the distal end portion of the proximal valve positioning portion 528 defines a fourth diameter D4 and the proximal end portion of the proximal valve positioning portion 528 defines a fifth diameter D5. As shown, D4 can be greater than D5 such that the proximal valve positioning portion 528 tapers towards the proximal end portion of the valve positioning structure 525. Such a configuration can result in the proximal valve positioning portion 528 having a frustoconical shape that tapers to towards the proximal end portion of the valve positioning structure 525.

[0241] As shown, the intermediate valve positioning portion 529 can have a cylindrical shape. For example, as shown the intermediate valve positioning portion 529 can define a third diameter D3 that is constant or a substantially constant (within 10%) along the axial length of the intermediate valve positioning portion 529. In some examples, the intermediate valve positioning portion 529 can define a third diameter D3 that varies no more than 10%THVMC-23950W001 along the axial length of the intermediate valve positioning portion 529. In some examples, at least one of the region between the distal valve positioning portion 526 and the intermediate valve positioning portion 529 and the region between the proximal valve positioning portion 528 and the intermediate valve positioning portion 529 can be flared. In some examples, the flared region can define a shoulder (for example, a distal shoulder or a proximal shoulder) of the valve positioning structure 525. For example, as shown, the second diameter D2 of the distal valve positioning portion 526 is greater than the third diameter D3 of the intermediate valve positioning portion 529. As further shown, the fourth diameter D4 of the proximal valve positioning portion 528 is greater than the third diameter D3 of the intermediate valve positioning portion 529. In some examples, forming a flared region on the valve positioning structure 525 can help further reduce axial movement of an implant (such as the prosthetic valve 10 or the prosthetic valve 150) mounted around the intermediate valve positioning portion 529.

[0242] As shown in FIG. 10A, the first diameter DI, the third diameter D3, and the fifth diameter D5 can be equal or substantially equal (within 10%). For example, the first diameter DI, the third diameter D3, and the fifth diameter D5 can be within 10% of each other. For example, DI, D3, and D5 can be equal or substantially equal to the outer diameter of a balloon (for example, the balloon 118) in a radially collapsed or deflated state in order to further minimize the outer diameter of the valve positioning structure 525. In some examples, the third diameter D3 can be greater than each one of the first diameter DI and the second diameter D2. In some examples, the third diameter D3 can be less than each one of the first diameter DI and the second diameter D2. In some examples, the third diameter D3 can be greater than each one of the fourth diameter D4 and the fifth diameter D5. In some examples, the third diameter D3 can be less than each one of the fourth diameter D4 and the fifth diameter D5.

[0243] Now referring to FIG. 10B, there is shown a flattened view of the frame 530. As shown, each of the distal valve positioning portion 526 and the proximal valve positioning portion 528 comprises the same arrangement of struts and / or cells, such that the frame 530 is axially symmetric about the intermediate valve positioning portion 529. However, in some examples, one of the distal valve positioning portion 526 and the proximal valve positioning portion 528 can include a different arrangement of struts and / or cells.THVMC-23950W001

[0244] The frame 530 can be shape set in the radially collapsed state shown in FIG. 10A to form the valve positioning structure 525. It should be understood that any frame disclosed herein that includes a proximal portion, a distal portion, and an intermediate portion (for example, any one of frames 1030, 1130, 1230, 1330, 1430, 1530, 1630, 1730, 1830, 1930, 2030, 2130, 2230, and 2330) can be shape set in the radially collapsed state to form a valve positioning structure having a similar shape as valve positioning structure 525 shown in FIG. 10A.

[0245] As shown, each of the distal valve positioning portion 526 and the proximal valve positioning portion 528 comprises a plurality of struts that includes a first plurality of struts 532 and a second plurality of struts 534. Each one of the first plurality of struts 532 (which are also referred to herein as a “plurality of angled linear struts,’- a “plurality of angled struts,” and / or a “plurality of linear struts”) can have a linear shape and can be oriented at an angle relative to an axial direction of the frame 530. The first plurality of struts 532 can be arranged into one or more rows 570 that extend in a circumferential direction of the frame 530 with the junctions between adjacent ends of the first plurality of struts 532 pointing either in the distal or proximal directions. For example, as shown, the first plurality of struts 532 are arranged into four rows 570. However, the first plurality of struts 532 can be arranged into any other number of rows (for example, one row, two rows, three rows, five rows, six rows, etc.) in other examples of the frame 530.

[0246] Each one of the second plurality of struts 534 (which are also referred to herein as a “plurality of zig-zag struts,” a “plurality of z-struts,” and / or a “plurality of jagged struts”) can have a zigzag or sawtooth shape. The plurality of second struts 534 be arranged into one or more rows 572 that extends in a circumferential direction of the frame 530 with the peaks formed along each of the plurality of second struts 534 pointing in the circumferential direction. For example, as shown, the second plurality of struts 534 are arranged into three rows 572. However, the second plurality of struts 534 can be arranged into any other number of rows (for example, one row, two rows, four rows, five rows, six rows, etc.) in other examples of the frame 530.

[0247] As shown, rows 570, 572 of the first and second pluralities of struts 532, 534 are arranged in an alternating pattern. In some examples, the illustrated arrangement of alternating rows 570, 572 can improve the flexibility of the valve positioning structure 525 while providing sufficient axial stiffness to support the balloon 118 and / or the prostheticTHVMC-23950W001 valve 150. For example, the first plurality of struts 532 can support the balloon 118 and / or the prosthetic valve 150, while the second plurality of struts 534 can bend when the valve positioning structure 525 is manipulated and subjected to external forces during use. Such an arrangement can better enable the valve positioning structure 525 to be more easily advanced through an introducer sheath and / or a patient’ s vasculature (for example, at or around the aortic arch).

[0248] The intermediate valve positioning portion 529 can comprise a third plurality of struts 536 (which are also referred to herein as a “plurality of axial linear struts,” a “plurality of connecting struts,” a “plurality of intermediate connecting struts,” and / or a “plurality of intermediate struts”) that connect the distal valve positioning portion 526 and the proximal valve positioning portion 528. In some examples, the third plurality of struts 536 can help minimize interactions between the frame 530 and a prosthetic heart valve’s leaflets (for example, leaflets 40 of prosthetic heart valve 10 or leaflets of valve 150). Each one of the third plurality of struts 536 can include a distal end and a proximal end. As shown, each one of the third plurality of struts 536 connects at its distal end to a junction of two struts 532 at the distal valve positioning portion 526. As further shown, each one of the third plurality of struts 536 connects at its proximal end to a junction of two of the first plurality of struts 532 at the proximal valve positioning portion 528.

[0249] In some examples, the frame 530 can be a unitary and / or fastener-free structure that can be formed from a single piece of material (for example, Nitinol), such as in the form of a tube. The frame 530 can comprise the plurality of struts (for example, pluralities of struts 532, 534, 536) formed into a plurality of cells. The plurality of struts and / or cells can be formed by removing portions (for example, via laser cutting) of the single piece of material.

[0250] Now referring to FIG. 10C, there is shown the valve positioning structure 525 mounted to a distal end portion of a delivery apparatus 500. The delivery apparatus 500 includes the intermediate shaft 106, the nose cone 122 disposed distally relative to the intermediate shaft 106, and the balloon 118 coupled to the intermediate shaft 106 and / or the nose cone 122. The balloon 118 is shown in the deflated state.

[0251] As shown, the valve positioning structure 525 is mounted around the balloon 118 (for example, to an external surface of the balloon 1 18). As further shown, the distal end of the distal valve positioning portion 526 can be fixed to the nose cone 122 and the proximal end of the proximal valve positioning portion 528 can be fixed to the intermediate shaft 106 (forTHVMC-23950W001 example, an interior or external surface of a distal end of the intermediate shaft 106). As further shown, the intermediate valve positioning portion 529 is aligned in an axial direction of the delivery apparatus 500 with the valve mounting portion 124 and / or the intermediate portion 118b of the balloon 118.

[0252] Now referring to FIG. 10D, there is shown the prosthetic valve 150 in its radially compressed state mounted to the distal end portion of the delivery apparatus 500. The prosthetic valve 150 can be mounted and / or crimped around the intermediate valve positioning portion 529 of the valve positioning structure 525 when the balloon 118 is in the deflated state, such that the prosthetic valve 150 is disposed between the distal valve positioning portion 526 and the proximal valve positioning portion 528. As shown, none of the distal valve positioning portion 526, the proximal valve positioning portion 528, or the intermediate valve positioning portion 529 overlap the outer surface of the prosthetic valve 150. In some examples, one or more portions of the valve positioning structure 525 can overlap a portion of the prosthetic valve 150.

[0253] As further shown, in the illustrated example, the intermediate valve positioning portion 529 prevents the prosthetic valve 150 from contacting the balloon 118. In some examples, the distal valve positioning portion 526 enables the delivery apparatus 100 to be more easily advanced through an introducer sheath and / or a patient’ s vasculature in a manner that protects against undesirable contact between the leading edge (the distal end) of the prosthetic valve 150 and the patient’s vasculature and between the leading edge of the prosthetic valve 150 and an inner surface of the introducer sheath. In some examples, the proximal valve positioning portion 528 can be configured to counteract proximally-directed forces applied by the prosthetic valve 150 during delivery of the valve 150, thereby maintaining the positioning of the prosthetic valve 150 on the balloon 118 as it is advanced through an introducer sheath and the patient’s vasculature.

[0254] Now referring to FIG. 10E, there is shown the prosthetic valve 150 mounted to the distal end portion of the delivery apparatus 500, wherein, the balloon 118, the prosthetic valve 150, and the valve positioning structure 525 are in radially expanded states. As shown, the intermediate valve positioning portion 529 is cylindrical when the valve positioning structure 525 is in the radially expanded state. As further shown, the distal valve positioning portion 526 tapers from the intermediate valve positioning portion 529 to the nose cone 122 and the proximal valve positioning portion 528 tapers from the intermediate valve positioningTHVMC-23950W001 portion 529 to the intermediate shaft 106 when the valve positioning structure 525 is in the radially expanded state.

[0255] Known delivery apparatuses used for delivering balloon-expandable prosthetic valve heart valves typically include balloons with relatively long distal and proximal sections that extend beyond the distal and proximal ends of the prosthetic valve. These distal and proximal balloon sections typically are inflated at a faster rate than the central section of the balloon on which the prosthetic valve is mounted. As a result, the balloon can assume a “dog bone” shape as it is being inflated such that the distal and proximal sections can be inflated to a greater diameter than the prosthetic valve, at least initially. This is advantageous in that the distal and proximal balloon sections help fix the position of the prosthetic valve on the balloon and minimize shifting of the prosthetic valve relative to the balloon as the balloon is inflated to deploy the prosthetic valve. However, the relatively long balloon can be make navigating a patient’s vasculature more difficult and may contact portions of the patient’s vasculature (for example, the sinotubular junction (STJ) and / or the left ventricular outflow tract (LVOT)) during a prosthetic valve implantation procedure.

[0256] Now referring to FIG. 11 , there is shown a distal end portion of a delivery apparatus 600. As shown, the delivery apparatus 600 includes the intermediate shaft 106, the inner shaft 108 extending coaxially through the intermediate shaft 106 to the nose cone 122, and a balloon 218 disposed around the inner shaft 108 and between the intermediate shaft 106 and the nose cone 122. The delivery apparatus 600 also includes an expandable, external valve positioning structure 625. Desirably, although not necessarily, no portion of the valve positioning structure 625 overlaps the outer surface of the prosthetic valve 150.

[0257] One exemplary difference between the balloon 218 and the previously illustrated balloon 118 is that the balloon 218 has a shorter axial length than the balloon 118. In some examples, the shorter axial length of the balloon 218 can help the delivery apparatus 600 better navigate the patient’s vasculature to avoid contact with portions of the patient’s vasculature (for example, the sinotubular junction (STJ) and / or the left ventricular outflow tract (LVOT)) during a prosthetic valve implantation procedure. Thus, the shorter axial length of the balloon 218 can help further minimize the risk of rupture and / or conduction disturbances at these locations within the patient’s vasculature.

[0258] Similarly, one exemplary difference between the valve positioning structure 625 and the previously illustrated valve positioning structure 525 is that the valve positioningTHVMC-23950W001 structure 625 has a shorter axial length than the valve positioning structure 525. In some examples, the valve positioning structure 625 can have the same overall construction and shape (in the expanded and collapsed states) as the valve positioning structure 525, except that the valve positioning structure 625 is shorter than the valve positioning structure 525.

[0259] FIG. 12 is a schematic profile view of four exemplary balloons for a delivery apparatus, according to one example. In particular, FIG. 12 offers a side-by-side comparison of the axial lengths (from the proximal-most end of the balloon to the distal-most end of the balloon) of the balloon 118 (which is also referred to herein as a “first balloon”), the balloon 218 (which is also referred to herein as a “second balloon”), a balloon 318 (which is also referred to herein as a “third balloon”), and a balloon 418 (which is also referred to herein as a “fourth balloon”). In some examples, the intermediate section (in other words, the valve mounting portion) of each of the second, third, and fourth balloons 218, 318, and 418, respectively, can have a length that is equal to or substantially equal (within 10%) to the length of the prosthetic valve in its radially compressed state. The balloon 218, 318, and 418 can be selected based on the size of the prosthetic valve to be implanted.

[0260] The first balloon 118 can have a first axial length, which can be in a range from 51 mm to 57 mm, such as from 52 mm to 56 mm, from 54 mm to 55 mm, and / or 54.5 mm.

[0261] The second balloon 218 can have a second axial length, which can be in a range from 45 mm to 51 mm, such as from 46 mm to 50 mm, from 47 mm to 49 mm, 47 mm to 48 mm, and / or 47.3 mm.

[0262] The third balloon 318 can have a third axial length, which can be in a range from 31 mm to 45 mm, such as from 32 mm to 44 mm, from 33 mm to 43 mm, from 34 mm to 42 mm, from 31 mm to 37 mm, from 32 mm to 36 mm, from 33 mm to 35 mm, and / or 34 mm.

[0263] The fourth balloon 418 can have a fourth axial length, which can be in a range from 25 mm to 31 mm, such as from 26 mm to 30 mm, from 27 mm to 29 mm, and / or 28 mm.

[0264] In some examples, delivery apparatuses that include a valve positioning structure (for example, any one of the disclosed valve positioning structures) can be compatible with any one of the first balloon 118, the second balloon 218, the third balloon 318, or the fourth balloon 418. In some examples, a distal end portion of a delivery apparatus that includes both a valve positioning structure and one of the second balloon, 218, third balloon 318, or fourth balloon 418 can be more easily advanced through the patient’s vasculature (for example, in and / or around the sinotubular junction and / or the left ventricular outflow tract)THVMC-23950W001 than a distal end portion of a delivery apparatus that includes a relatively axially longer balloon.

[0265] Now referring to FIG. 13, there is shown a flattened view of a frame 730 of an expandable, external valve positioning structure, according to one example. In some examples, the frame 730 can be shape set to form any one of a distal valve positioning structure or a proximal valve positioning structure similar to those shown in FIGS. 5A-5B. In some examples, the frame 730 can be used to form a valve positioning structure that includes both proximal and distal valve positioning portions interconnected to each other with an intermediate portion, for example, an intermediate portion comprising axial struts 536.

[0266] The frame 730 can comprise a plurality of struts 732. Each one of the plurality of struts 732 can comprise a first end portion 733 oriented parallel to an axial direction of the frame 730 and a second end portion 735 oriented parallel to the axial direction of the frame 730. As shown, the first end portion 733 is offset in a circumferential direction from the second end portion 735. Each one of the plurality of struts 732 can further comprise an intermediate portion 737 oriented at an angle relative to the axial direction of the frame 730. The cross-sectional width of each one of the plurality of struts 732 can vary along its length. For example, as shown, the cross-sectional width of each one of the plurality of struts 732 is wider at the first and second end portions 733, 735 than at the intermediate portion 737 disposed between the first and second end portions 733, 735. In some examples, the reduced cross-section at the intermediate portion 737 can better allow the plurality of struts 732 to bend or flex, which can beneficially result in a more flexible frame 730 that can be more easily navigated through the patient’s vasculature.

[0267] Adjacent ones of the plurality of struts 732 can form apices 766 at the axial ends of the frame 730. The apices 766 can be formed by the second end portions 735 of adjacent ones of the plurality of struts 732. As shown, each apex 766 can form a circular head 767. In some examples, the rounded shape of the circular head 767 can make it easier to advance the delivery apparatus. In some examples, the atraumatic shape of the circular head 767 can further minimize potential damage to the prosthetic valve and / or the balloon when the circular head 767 contacts the prosthetic valve and / or balloon during inflation. In between the axial ends of the frame 730, adjacent ones of the plurality of struts 732 can connect with three other ones of the plurality of struts 732 at junctions 762 (which are also referred to herein as “unions”). Each junction 762 can comprise four of the plurality of struts 732 thatTHVMC-23950W001 connect via a crossbar 763 extending in a circumferential direction of the frame 730 to form an H-shaped arrangement of struts.

[0268] As shown, the frame 730 is symmetric in the axial direction of the frame 730. Thus, each axial end of the frame 730 can be either the proximal end of the frame 730 or the distal end of the frame 730. Similarly, apices 766 can be either the proximal apices or distal apices of the frame 730. In this way, the frame 730 can be used to form either a proximal valve positioning structure or a distal valve positioning structure and / or can be invertible.

[0269] In some examples, the frame 730 can form a distal valve positioning structure or a proximal valve positioning structure and can be shape set such as shown in either FIG. 5A or FIG. 5B. In some examples, a valve positioning structure can comprise a first frame 730 forming a proximal portion of the valve positioning structure, a second frame 730 forming a distal portion of the valve positioning structure, and an intermediate portion (for example, a plurality of axial struts 536) interconnecting the first and second frames 730.

[0270] Now referring to FIG. 14 A, there is shown an expandable, external proximal valve positioning structure 828, according to one example. The valve positioning structure 828 can comprise a frame 830. In some examples, the frame 830 can be used to form either the proximal valve positioning structure or an expandable, external distal valve positioning structure. In some examples, the proximal valve positioning structure 828 can comprise the frame 830 having a first stiffness and the distal valve positioning structure can comprise a second, different frame having a second stiffness. In some examples, the second stiffness can be less than the first stiffness such that the distal valve positioning structure expands and / or collapses first, which can better facilitate retrieval of a distal end portion of a delivery apparatus around which the proximal valve positioning structure 828 is mounted.

[0271] Now referring to FIG. 14B, there is shown the frame 830 of the proximal valve positioning structure 828, wherein the frame 830 is shown in a flattened configuration. Although the frame 830 is primarily shown with reference to the proximal valve positioning structure 828, the frame 830 can be used to form a distal valve positioning structure or any other valve positioning structure (for example, a valve positioning structure that includes both proximal and distal valve positioning portions interconnected to each other with an intermediate portion, such as an intermediate portion comprising axial struts 536).

[0272] The frame 830 can comprise a plurality of struts that includes a first plurality of struts 832, a second plurality of struts 834, a third plurality of struts 836, a fourth plurality of strutsTHVMC-23950W001838, a fifth plurality of struts 840, and a sixth plurality of struts 842. The first plurality of struts 832 (which are also referred to herein as a “plurality of axial linear struts,” a “plurality of axial struts,” and / or a “plurality of linear struts”) can be arranged into a first row 844 that extends in a circumferential direction of the frame 830. Each one of the first plurality of struts 832 can be oriented in an axial direction of the frame 830. Each one of the first plurality of struts 832 can comprise a distal end and a proximal end. The distal ends of adjacent ones of the first plurality of struts 832 can be connected at semicircular distal apices 856 that define a distal end of the frame 830. The proximal ends of adjacent ones of the first plurality of struts 832 can be connected at junctions 858 (which are also referred to herein as “unions”).

[0273] The second plurality of struts 834 (which are also referred to herein as a “plurality of axial linear struts,” a “plurality of axial struts,” and / or a “plurality of linear struts”) can be arranged into a second row 846 that extends in the circumferential direction of the frame 830. Each one of the second plurality of struts 834 can be oriented in the axial direction of the frame 830. Each one of the second plurality of struts 834 can comprise a distal end and a proximal end. The distal ends of adjacent ones of the second plurality of struts 834 can be connected at the junctions 858. Each junction 858 can be formed by connecting the axially- extending proximal ends of two adjacent ones of the second plurality of struts 834 and the axially -extending distal ends of two adjacent ones of the second plurality of struts 834 via a crossbar 863 that extends in the circumferential direction of the frame 830 to form an Id- shaped arrangement of struts. The proximal ends of adjacent ones of the first plurality of struts 832 can be connected at junctions 860 (which are also referred to herein as “unions”).

[0274] The third plurality of struts 836 (which are also referred to herein as a “plurality of axial linear struts,” a “plurality of axial struts,” and / or a “plurality of linear struts”) can be arranged into a third row 848 that extends in the circumferential direction of the frame 830. Each one of the third plurality of struts 836 can be oriented in the axial direction of the frame 830. Each one of the third plurality of struts 836 can comprise a distal end and a proximal end. The distal ends of adjacent ones of the third plurality of struts 836 can be connected at junctions 860. The proximal ends of adjacent ones of the third plurality of struts 836 can be connected at junctions 862 (which are also referred to herein as “unions”). Similar to the junctions 858, each junction 862 can include four struts (for example, two adjacent ones ofTHVMC-23950W001 the third plurality of struts 836 and two adjacent ones of the fourth plurality of struts 838) connected by the crossbar 863 to form the H-shaped arrangement of struts.

[0275] The fourth plurality of struts 838 (which are also referred to herein as a “plurality of axial linear struts,” a “plurality of axial struts,” and / or a “plurality of linear struts”) can be arranged into a fourth row 850 that extends in the circumferential direction of the frame 830. Each one of the fourth plurality of struts 838 can be oriented in the axial direction of the frame 830. Each one of the fourth plurality of struts 838 can comprise a distal end and a proximal end. The distal ends of adjacent ones of the fourth plurality of struts 838 can be connected at junctions 862. The proximal ends of adjacent ones of the fourth plurality of struts 838 can be connected at junctions 864 (which are also referred to herein as “unions”).

[0276] The fifth plurality of struts 840 (which are also referred to herein as a “plurality of axial linear struts,” a “plurality of axial struts,” and / or a “plurality of linear struts”) can be arranged into a fifth row 852 that extends in the circumferential direction of the frame 830. Each one of the fifth plurality of struts 840 can be oriented in the axial direction of the frame 830. Each one of the fifth plurality of struts 840 can comprise a distal end and a proximal end. The distal ends of adjacent ones of the fifth plurality of struts 840 can be connected at junctions 864. The proximal ends of adjacent ones of the fifth plurality of struts 840 can be connected at junctions 866 (which are also referred to herein as “unions”). Similar to the junctions 858, 862, each junction 866 can include four struts (for example, two adjacent ones of the fifth plurality of struts 840 and two adjacent ones of the sixth plurality of struts 842) connected by the crossbar 863 to form the H-shaped arrangement of struts.

[0277] The sixth plurality of struts 842 (which are also referred to herein as a “plurality of axial linear struts,” a “plurality of axial struts,” and / or a “plurality of linear struts”) can be arranged into a sixth row 854 that extends in the circumferential direction of the frame 830. Each one of the sixth plurality of struts 842 can be oriented in the axial direction of the frame 830. Each one of the sixth plurality of struts 842 can comprise a distal end and a proximal end. The proximal ends of adjacent ones of the sixth plurality of struts 842 can be connected at semicircular proximal apices 868 that define a proximal end of the frame 830. The distal ends of adjacent ones of the sixth plurality of struts 842 can be connected at junctions 866.

[0278] The struts of the frame 830 can be arranged and / or connected to form a plurality of cells. For example, the first and second pluralities of struts 832, 834 can connect to each other to form a first circumferentially-extending row of cells 870. Similarly, the third andTHVMC-23950W001 fourth pluralities of struts 836, 838 can be connected to each other to form a second row of cells 872. Similar, the fifth and six pluralities of struts 840, 842 can be connected to each other to form a third row of cells 874. Although the illustrated frame 830 includes three rows of cells 870, 872, 874, other examples of the frame 830 can include one, two, four, five, six, etc. rows of cells.

[0279] As shown, each cell of the frame 830 has a “stadium” or “capsule” shape that includes two parallel sides defining the circumferential ends of each cell and two semicircular ends defining the axial ends of each cell. However, in other examples, the struts of the frame 830 can be arranged to form cells with different shapes (for example, circles, triangles, diamonds, squares, rectangles, pentagons, hexagons, heptagons, octagons, etc.).

[0280] Now referring to FIG. 15, there is shown a frame 930 in a flattened configuration for a valve positioning structure, according to one example. In some examples, the frame 930 can be formed into either one of a proximal valve positioning structure or a distal valve positioning structure, and optionally can be shape set as shown in either FIG. 5A or FIG. 5B. In some examples, a valve positioning structure can comprise a first frame 930 forming a proximal portion of the valve positioning structure, a second frame 930 forming a distal portion of the valve positioning structure, and an intermediate portion (for example, a plurality of axial struts 536) interconnecting the first and second frames.

[0281] The frame 930 can share certain similarities with the frame 230 that is best illustrated in FIG. 5C. One exemplary difference between the frame 930 and the frame 230 is that the frame 930 includes a fourth row of cells 982 at a distal end of the frame 930. Each cell 982 can comprise a box-shaped head 986 and a connecting strut 984 extending between the box- shaped head 986 and a corresponding distal apex 256. In some examples, fabric, cloth, foam, and / or any padding can be coupled to any of the box-shaped heads 986, such as by stitching the fabric, cloth, foam or padding to the heads 986 with sutures. In some examples, the fabric, cloth, foam, or padding can cover the heads 986. In some examples, when the frame 930 is formed into a proximal valve positioning structure and is connected to a shaft of the delivery apparatus (for example, the shaft 104), the heads 986 and the attached fabric, cloth, foam and / or padding can form a distal tip portion (similar to tip portion 128) that can help position the prosthetic heart valve 150 on the balloon 1 18 in an off-balloon delivery procedure, similar to that shown in FIG. 2B. The fourth row of cells 982 can be disposed closest to the prosthetic valve 150 when the frame 930 is formed into a proximal valveTHVMC-23950W001 positioning structure and coupled to a delivery apparatus. For example, when the frame 930 is formed into a proximal valve positioning structure, the resulting valve positioning structure can be configured such that the fourth row of cells 982 (in particular, the box-shaped heads 986 of the fourth row of cells 982) beneficially form a more continuous surface to contact a proximal end of the prosthetic valve 150. In some examples, the frame 930 can be inverted such that the fourth row of cells 982 is at a proximal end of the frame 930. In this way, when the frame 930 is formed into a distal valve positioning structure, the resulting valve positioning structure can be configured such that the fourth row of cells 982 (in particular, the box-shaped heads 986 of the fourth row of cells 982) beneficially form a more continuous surface to contact a distal end of the prosthetic valve 150.

[0282] FIG. 16 is a flattened view of a frame 1030 of a valve positioning structure, according to one example. A valve positioning structure of a delivery apparatus can be formed at least in part by shape setting the frame 1030 in a radially compressed state (for example, in the shape of the valve positioning structure 525 shown in FIG. 10A). The frame 1030 comprises a distal valve positioning portion 1026, a proximal valve positioning portion 1028, and an intermediate valve positioning portion 1029 disposed therebetween.

[0283] The distal valve positioning portion 1026 can include a plurality of struts that includes a first plurality of struts 1082 and a second plurality of struts 1084. The first plurality of struts 1082 (which are also referred to herein as a “plurality of angled linear struts,” a “plurality of angled struts,” and / or a “plurality of linear struts”) can be arranged into a first row 1092 that extends in a circumferential direction of the frame 1030. Each one of the first plurality of struts 1082 can be oriented at an angle relative to an axial direction of the frame 1030. Each one of the first plurality of struts 1082 can comprise a distal end and a proximal end. The distal ends of adjacent ones of the first plurality of struts 1032 can be connected at curved or rounded distal apices 1083d that define a distal end of the distal valve positioning portion 1026 and / or the frame 1030. The proximal ends of adjacent ones of the first plurality of struts 1082 can be connected at curved or rounded apices 1083p.

[0284] The second plurality of struts 1084 (which are also referred to herein as a “plurality of angled linear struts,” a “plurality of angled struts,” and / or a “plurality of linear struts”) can be arranged into a second row 1094 that extends in the circumferential direction of the frame 1030. The second row 1094 can be proximally disposed relative to the first row 1092. Each one of the second plurality of struts 1084 can be oriented at an angle relative to the axialTHVMC-23950W001 direction of the frame 1030. Each one of the second plurality of struts 1084 can comprise a distal end and a proximal end. The distal ends of adjacent ones of the second plurality of struts 1084 can be connected at curved or rounded apices 1085d. The proximal ends of adjacent ones of the second plurality of struts 1084 can be connected at curved or rounded proximal apices 1085p that define a proximal end of the distal valve positioning portion 1026.

[0285] The distal valve positioning portion 1026 can further include a plurality of connecting struts 1063 (which are also referred to herein as a “plurality of axial linear connecting struts,” a “plurality of axial connecting struts,” and / or a “plurality of linear connecting struts”). Each one of the plurality of connecting struts 1063 can extend in an axial direction of the frame 1030 from one of the distal apices 1083d to an axially adjacent one of apices 1085p. As shown, the plurality of connecting struts 1063 connect every third distal apex 1083d and apex 1085p in the circumferential direction. However, the plurality of connecting struts 1063 can be arranged to connect any number of apices 1083d, 1085p. In some examples, the distal valve positioning portion 1026 can be longer in an axial direction than the proximal valve positioning portion 1028.

[0286] The proximal valve positioning portion 1028 can comprise a plurality of struts that includes a first plurality of struts 1032, a second plurality of struts 1034, a third plurality of struts 1036, a fourth plurality of struts 1038, a fifth plurality of struts 1040, and a sixth plurality of struts 1042. The first plurality of struts 1032 (which are also referred to herein as a “plurality of angled linear struts,” a “plurality of angled struts,” and / or a “plurality of linear struts”) can be arranged into a first row 1044 that extends in the circumferential direction of the frame 1030. Each one of the first plurality of struts 1032 can be oriented at an angle relative to the axial direction of the frame 1030. Each one of the first plurality of struts 1032 can comprise a distal end and a proximal end. The distal ends of adjacent ones of the first plurality of struts 1032 can be connected at curved or rounded distal apices 256 that define a distal end of the proximal valve positioning portion 1028. The proximal ends of adjacent ones of the first plurality of struts 1032 can be connected at junctions 1058 (which are also referred to herein as “unions”).

[0287] The second plurality of struts 1034 (which are also referred to herein as a “plurality of angled linear struts,” a “plurality of angled struts,” and / or a “plurality of linear struts”) can be arranged in a second row 1046 that extends in the circumferential direction of the frame 1030THVMC-23950W001 and is proximally disposed relative to the first row 1044. Each one of the second plurality of struts 1034 can be oriented at an angle relative to the axial direction of the frame 1030. Each one of the second plurality of struts 1034 can comprise a distal end and a proximal end. The distal ends of adjacent ones of the second plurality of struts 1034 can be connected at the junctions 1058. The proximal ends of adjacent ones of the second plurality of struts 1034 can be connected at junctions 1060 (which are also referred to herein as “unions”).

[0288] The third plurality of struts 1036 (which are also referred to herein as a “plurality of angled linear struts,” a “plurality of angled struts,” and / or a “plurality of linear struts”) can be arranged in a third row 1048 that extends in the circumferential direction of the frame 1030 and is proximally disposed relative to the second row 1046. Each one of the third plurality of struts 1036 can be oriented at an angle relative to the axial direction of the frame 1030. Each one of the third plurality of struts 1036 can comprise a distal end and a proximal end. The distal ends of adjacent ones of the third plurality of struts 1036 can be connected at junctions 1060. The proximal ends of adjacent ones of the third plurality of struts 1036 can be connected at junctions 1062 (which are also referred to herein as “unions”).

[0289] The fourth plurality of struts 1038 (which are also referred to herein as a “plurality of angled linear struts,” a “plurality of angled struts,” and / or a “plurality of linear struts”) can be arranged in a fourth row 1050 that extends in the circumferential direction of the frame 1030 and is proximally disposed relative to the third row 1048. Each one of the fourth plurality of struts 1038 can be oriented at an angle relative to the axial direction of the frame 1030. Each one of the fourth plurality of struts 1038 can comprise a distal end and a proximal end. The distal ends of adjacent ones of the fourth plurality of struts 1038 can be connected at junctions 1062. The proximal ends of adjacent ones of the fourth plurality of struts 1038 can be connected at junctions 1064 (which are also referred to herein as “unions”).

[0290] The fifth plurality of struts 1040 (which are also referred to herein as a “plurality of angled linear struts,” a “plurality of angled struts,” and / or a “plurality of linear struts”) can be arranged in a fifth row 1052 that extends in the circumferential direction of the frame 1030 and is proximally disposed relative to the fourth row 1050. Each one of the fifth plurality of struts 1040 can be oriented at an angle relative to the axial direction of the frame 1030. Each one of the fifth plurality of struts 1040 can comprise a distal end and a proximal end. The distal ends of adjacent ones of the fifth plurality of struts 1040 can be connected at junctionsTHVMC-23950W0011064. The proximal ends of adjacent ones of the fifth plurality of struts 1040 can be connected at junctions 1066 (which are also referred to herein as “unions’").

[0291] The sixth plurality of struts 1042 (which are also referred to herein as a “plurality of angled linear struts,” a “plurality of angled struts,” and / or a “plurality of linear struts”) can be arranged in a sixth row 1054 that extends in the circumferential direction of the frame 1030 and is proximally disposed relative to the fifth row 1052. Each one of the sixth plurality of struts 1042 can be oriented at an angle relative to the axial direction of the frame 1030. Each one of the sixth plurality of struts 1042 can comprise a distal end and a proximal end. The distal ends of adjacent ones of the sixth plurality of struts 1042 can be connected at junctions 1066. The proximal ends of adjacent ones of the fifth plurality of struts 1040 can be connected at curved or rounded proximal apices 1068 that define a proximal end of the proximal valve mounting portion 1028 and / or the frame 1030.

[0292] The struts of the proximal valve mounting portion 1028 can be arranged and / or connected to form a plurality of cells. For example, the first and second pluralities of struts 1032, 1034 can connect to each other to form a first circumferentially-extending row of cells 1070. Similarly, the third and fourth pluralities of struts 1036, 1038 can be connected to each other to form a second row of cells 1072. Similar, the fifth and six pluralities of struts 1040, 1042 can be connected to each other to form a third row of cells 1074. Although the illustrated proximal valve mounting portion 1028 includes three rows of cells 1070, 1072, 1074, other examples of the proximal valve mounting portion 1028 can include one, two, four, five, six, etc. rows of cells.

[0293] As shown, each cell of the proximal valve mounting portion 1028 has a diamond shape. However, in other examples, the struts of the proximal valve mounting portion 1028 can be arranged to form cells with different shapes (for example, circles, triangles, other parallelograms, pentagons, hexagons, heptagons, octagons, etc.).

[0294] The intermediate valve positioning portion 1029 can comprise a plurality of axially- extending intermediate connecting struts 1065 (which are also referred to herein as “intermediate struts”). As shown, each one of the plurality of axially-extending intermediate connecting struts 1065 connects a proximal apex 1085p of the distal valve positioning portion 1026 to a corresponding distal apex 1056 of the proximal valve positioning portion 1028.

[0295] FIG. 17 is a flattened view of a frame 1130 of a valve positioning structure, according to one example. A valve positioning structure of a delivery apparatus can be formed at leastTHVMC-23950W001 in part by shape setting the frame 1130 in a radially compressed state (for example, the state of the valve positioning structure 525 shown in FIG. 10A). The frame 1130 can include a plurality of struts 1132 (which are also referred to herein as a “plurality of angled linear struts,” a “plurality of angled struts,” and / or a “plurality of linear struts”). The plurality of struts 1032 can be arranged into one or more rows 1144 that extends in a circumferential direction of the frame 1130. Within each row 1144, the plurality of struts 1132 can be arranged into a serpentine pattern that extends in the circumferential direction. Each one of the plurality of struts 1132 can be oriented at an angle relative to an axial direction of the frame 1130. Each one of the plurality of struts 1132 can comprise a distal end and a proximal end. The distal ends of adjacent ones of the plurality of struts 1132 can be connected at curved or rounded apices 1156. The proximal ends of adjacent ones of the plurality of struts 1132 can be connected at curved or rounded apices 1158.

[0296] The frame 1130 can also include a plurality of connecting struts 1163 (which are also referred to herein as a “plurality of axial linear connecting struts,” a “plurality of axial connecting struts,” and / or a “plurality of linear connecting struts”). Each one of the plurality of connecting struts 1163 can extend in the axial direction of the frame 1130. Each one of the plurality of connecting struts 1163 can connect one of the apices 1156 with an axially adjacent one of the apices 1158. As shown, each one of the plurality of connecting struts 1163 connects every fifth apex 1156 with a corresponding apex 1158 in the circumferential direction. However, the plurality of connecting struts 1163 can be arranged to connect any number of apices 1156, 1158.

[0297] In some examples, the frame 1130 comprises a distal valve positioning portion 1126, a proximal valve positioning portion 1128, and an intermediate valve positioning portion 1129 disposed therebetween. In some examples, a portion of the frame 1130 (for example, the distal valve positioning portion 1126 or the proximal valve positioning portion 1128) can be shape set to form a distal valve positioning structure or a proximal valve positioning structure similar to those shown in FIGS. 5A-5C. In some examples, the distal valve positioning portion 1126 can be axially longer than the proximal valve positioning portion 1128.

[0298] FIG. 18 is a flattened view of a frame 1230 of a valve positioning structure, according to one example. A valve positioning structure of a delivery apparatus can be formed at leastTHVMC-23950W001 in part by shape setting the frame 1230 in a radially compressed state (for example, the state of the valve positioning structure 525 shown in FIG. 10A).

[0299] The frame 1230 can comprise a distal valve positioning portion 1226, the proximal valve positioning portion 1028 proximally disposed relative to the distal valve positioning portion 1226, and the intermediate valve positioning portion 1029 disposed between the distal valve positioning portion 1226 and the proximal valve positioning portion 1028. In some examples, the distal valve positioning portion 1226 can be axially longer than the proximal valve positioning portion 1228.

[0300] The distal valve positioning portion 1226 can include a plurality of struts that includes a first plurality of struts 1232, a second plurality of struts 1234, a third plurality of struts 1236, a fourth plurality of struts 1238, and a fifth plurality of struts 1240. The first plurality of struts 1232 (which are also referred to herein as a “plurality of angled linear struts,” a “plurality of angled struts,” and / or a “plurality of linear struts”) can be arranged into a first row 1244 that extends in a circumferential direction of the frame 1230. Each one of the first plurality of struts 1232 can be oriented at an angle relative to an axial direction of the frame 1230. Each one of the first plurality of struts 1232 can comprise a distal end and a proximal end. The distal ends of adjacent ones of the first plurality of struts 1232 can be connected at curved or rounded distal apices 1283d that define a distal end of the distal valve positioning portion 1226 and / or the frame 1230. The proximal ends of adjacent ones of the first plurality of struts 1082 can be connected at curved or rounded apices 1283p.

[0301] The second plurality of struts 1234 (which are also referred to herein as a “plurality of angled linear struts,” a “plurality of angled struts,” and / or a “plurality of linear struts”) can be arranged into a second row 1246 that extends in the circumferential direction of the frame 1230. Each one of the second plurality of struts 1234 can be oriented at an angle relative to the axial direction of the frame 1230. Each one of the second plurality of struts 1234 can comprise a distal end and a proximal end. The distal ends of adjacent ones of the second plurality of struts 1234 can be connected at curved or rounded apices 1285d. The proximal ends of adjacent ones of the second plurality of struts 1234 can be connected at curved or rounded apices 1285p.

[0302] The third plurality of struts 1236 (which are also referred to herein as a “plurality of angled linear struts,” a “plurality of angled struts,” and / or a “plurality of linear struts”) can be arranged into a third row 1248 that extends in the circumferential direction of the frame 1230.THVMC-23950W001Each one of the third plurality of struts 1236 can be oriented at an angle relative to the axial direction of the frame 1230. Each one of the third plurality of struts 1236 can comprise a distal end and a proximal end. The distal ends of adjacent ones of the third plurality of struts 1236 can be connected at curved or rounded apices 1287d. The proximal ends of adjacent ones of the third plurality of struts 1236 can be connected at curved or rounded apices 1287p.

[0303] The fourth plurality of struts 1238 (which are also referred to herein as a “plurality of angled linear struts,” a “plurality of angled struts,” and / or a “plurality of linear struts”) can be arranged into a fourth row 1250 that extends in the circumferential direction of the frame 1230. Each one of the fourth plurality of struts 1238 can be oriented at an angle relative to the axial direction of the frame 1230. Each one of the fourth plurality of struts 1238 can comprise a distal end and a proximal end. The distal ends of adjacent ones of the fourth plurality of struts 1238 can be connected at curved or rounded apices 1289d. The proximal ends of adjacent ones of the fourth plurality of struts 1238 can be connected at curved or rounded apices 1289p.

[0304] The fifth plurality of struts 1240 (which are also referred to herein as a “plurality of angled linear struts,” a “plurality of angled struts,” and / or a “plurality of linear struts”) can be arranged into a fifth row 1252 that extends in the circumferential direction of the frame 1230. Each one of the fifth plurality of struts 1240 can be oriented at an angle relative to the axial direction of the frame 1230. Each one of the fifth plurality of struts 1240 can comprise a distal end and a proximal end. The distal ends of adjacent ones of the fifth plurality of struts 1240 can be connected at curved or rounded apices 129 Id. The proximal ends of adjacent ones of the fifth plurality of struts 1240 can be connected at curved or rounded proximal apices 1291p, which can constitute a proximal end of the distal valve positioning portion 1226.

[0305] The distal valve positioning portion 1226 can further include a plurality of connecting struts 1263 (which are also referred to herein as a “plurality of axial linear connecting struts,” a “plurality of axial connecting struts,” and / or a “plurality of linear connecting struts”). Each one of the plurality of connecting struts 1263 can extend in an axial direction of the frame 1230 to connect apices of the frame 1230. For example, as shown, connecting struts 1263 can extend between and connect apices 1283p, 1285p, apices 1285p, 1287p, apices 1287p, 1289p, and apices 1289p, 1291p.THVMC-23950W001

[0306] As shown, each one of the plurality of connecting struts 1065 of the intermediate valve positioning portion 1029 connects each one of the proximal apices 129 Ip of the distal valve positioning portion 1226 with an axially adjacent one of the distal apices 1056 of the proximal valve positioning portion 1028.

[0307] FIG. 19 is a flattened view of a frame 1330 of a valve positioning structure, according to one example. A valve positioning structure of a delivery apparatus can be formed at least in part by shape setting the frame 1330 in a radially compressed state (for example, in the shape of the valve positioning structure 525 shown in FIG. 10A).

[0308] The frame 1330 can comprise a distal valve positioning portion 1326, the proximal valve positioning portion 1028 proximally disposed relative to the distal valve positioning portion 1326, and the intermediate valve positioning portion 1029 disposed between the distal valve positioning portion 1326 and the proximal valve positioning portion 1028. In some examples, the distal valve positioning portion 1326 can be axially longer than the proximal valve positioning portion 1328.

[0309] The distal valve positioning portion 1326 can include a plurality of struts that includes a first plurality of struts 1332, a second plurality of struts 1334, a third plurality of struts 1336, a fourth plurality of struts 1338, and a fifth plurality of struts 1340. The first plurality of struts 1332 (which are also referred to herein as a “plurality of axial linear struts,” a “plurality of axial struts,” and / or a “plurality of linear struts”) can be arranged into a first row 1344 that extends in a circumferential direction of the frame 1330. Each one of the first plurality of struts 1332 can be oriented in an axial direction of the frame 1330. Each one of the first plurality of struts 1332 can comprise a distal end and a proximal end. The distal ends of adjacent ones of the first plurality of struts 1332 can be connected at curved, rounded, or semicircular distal apices 1383d that define a distal end of the distal valve positioning portion 1326 and / or the frame 1330. The proximal ends of adjacent ones of the first plurality of struts 1332 can be connected at curved or rounded apices 1383p.

[0310] The second plurality of struts 1334 (which are also referred to herein as a “plurality of axial linear struts,” a “plurality of axial struts,” and / or a “plurality of linear struts”) can be arranged into a second row 1346 that extends in the circumferential direction of the frame 1330. Each one of the second plurality of struts 1334 can be oriented in the axial direction of the frame 1330. Each one of the second plurality of struts 1334 can comprise a distal end and a proximal end. The distal ends of adjacent ones of the second plurality of struts 1334 can beTHVMC-23950W001 connected at curved, rounded, or semicircular apices 1385d. The proximal ends of adjacent ones of the second plurality of struts 1334 can be connected at curved, rounded, or semicircular apices 1385p.

[0311] The third plurality of struts 1336 (which are also referred to herein as a “plurality of axial linear struts,” a “plurality of axial struts,” and / or a “plurality of linear struts”) can be arranged into a third row 1348 that extends in the circumferential direction of the frame 1330. Each one of the third plurality of struts 1336 can be oriented in the axial direction of the frame 1330. Each one of the third plurality of struts 1336 can comprise a distal end and a proximal end. The distal ends of adjacent ones of the third plurality of struts 1336 can be connected at curved, rounded, or semicircular 1387d. The proximal ends of adjacent ones of the third plurality of struts 1336 can be connected at curved, rounded, or semicircular apices 1387p.

[0312] The fourth plurality of struts 1338 (which are also referred to herein as a “plurality of axial linear struts,” a “plurality of axial struts,” and / or a “plurality of linear struts”) can be arranged into a fourth row 1350 that extends in the circumferential direction of the frame 1330. Each one of the fourth plurality of struts 1338 can be oriented in the axial direction of the frame 1330. Each one of the fourth plurality of struts 1338 can comprise a distal end and a proximal end. The distal ends of adjacent ones of the fourth plurality of struts 1338 can be connected at curved, rounded, or semicircular apices 1389d. The proximal ends of adjacent ones of the fourth plurality of struts 1338 can be connected at curved, rounded, or semicircular apices 1389p.

[0313] The fifth plurality of struts 1340 (which are also referred to herein as a “plurality of axial linear struts,” a “plurality of axial struts,” and / or a “plurality of linear struts”) can be arranged into a fifth row 1352 that extends in the circumferential direction of the frame 1330. Each one of the fifth plurality of struts 1340 can be oriented in the axial direction of the frame 1330. Each one of the fifth plurality of struts 1340 can comprise a distal end and a proximal end. The distal ends of adjacent ones of the fifth plurality of struts 1340 can be connected at curved, rounded, or semicircular apices 139 Id. The proximal ends of adjacent ones of the fifth plurality of struts 1340 can be connected at curved, rounded, or semicircular proximal apices 1391 p, which can constitute a proximal end of the distal valve positioning portion 1326.THVMC-23950W001

[0314] The distal valve positioning portion 1326 can further include a plurality of connecting struts 1363 (which are also referred to herein as a “plurality of axial linear connecting struts,” a “plurality of axial connecting struts,’" and / or a “plurality of linear connecting struts”). Each one of the plurality of connecting struts 1363 can extend in an axial direction of the frame 1330 to connect apices of the frame 1330. For example, as shown, connecting struts 1363 can extend between and connect apices 1383p, 1385p, apices 1385p, 1387p, apices 1387p, 1389p, and apices 1389p, 1391p.

[0315] As shown, each one of the plurality of connecting struts 1065 of the intermediate valve positioning portion 1029 connects each one of the proximal apices 139 Ip of the distal valve positioning portion 1326 with an axially adjacent one of the distal apices 1056 of the proximal valve positioning portion 1028.

[0316] FIG. 20 A is a side view of a distal end portion of a delivery apparatus 1400, according to one example. The delivery apparatus 1400 includes the intermediate shaft 106, the inner shaft 108, the balloon 118, and the nose cone 122. As shown, the balloon 118 is shown in a deflated state. One exemplary difference between the presently illustrated delivery apparatus 1400 and other delivery apparatuses illustrated herein is that the delivery apparatus 1400 includes a valve positioning structure 1425 disposed around the balloon 118. The valve positioning structure 1425 includes a frame 1430, which is further described with respect to FIG. 20C. The valve positioning structure 1425 is shown in a radially collapsed state.

[0317] FIG. 20B is a side view of the distal end portion of the delivery apparatus 1400, wherein the balloon 118 is in an inflated state and the valve positioning structure 1425 is in a radially expanded state.

[0318] FIG. 20C is a flattened view of the frame 1430 of the valve positioning structure 1425, according to one example. The valve positioning structure 1425 of the delivery apparatus 1400 can be formed at least in part by shape setting the frame 1430 in the radially collapsed state.

[0319] The frame 1430 can comprise a distal valve positioning portion 1426, the proximal valve positioning portion 1028 proximally disposed relative to the distal valve positioning portion 1426, and the intermediate valve positioning portion 1029 disposed between the distal valve positioning portion 1426 and the proximal valve positioning portion 1028. In some examples, the distal valve positioning portion 1426 can be axially longer than the proximal valve positioning portion 1428.THVMC-23950W001

[0320] The distal valve positioning portion 1426 can share certain similarities with the distal valve positioning structure 1326 illustrated in FIG. 19. One exemplary difference between the distal valve positioning portion 1426 and the distal valve positioning structure 1326 is that the distal valve positioning portion 1426 includes a plurality of serpentine connecting struts 1463 (which are also referred to herein as a “plurality of connecting struts” and / or a “plurality of connecting s-struts”) instead of the plurality of linear connecting struts 1363. As shown, each one of the plurality of serpentine connecting struts 1463 can include at least one semicircular turn, such as two semicircular turns as shown. The plurality of serpentine connecting struts 1463 can extend in an axial direction of the frame 1430 to connect apices of the frame 1430. For example, as shown, the serpentine connecting struts 1463 can extend between and connect apices 1383p, 1385p, apices 1385p, 1387p, apices 1387p, 1389p, and apices 1389p, 1391p.

[0321] FIG. 21 is a flattened view of a frame 1530 of a valve positioning structure, according to one example. A valve positioning structure of a delivery apparatus can be formed at least in part by shape setting the frame 1530 in a radially compressed state. For example, the frame 1530 can be formed into either one of a proximal valve positioning structure or a distal valve positioning structure, and optionally can be shape set in the radially collapsed state similar to the valve positioning structures shown in FIG. 5 A and FIG. 5B. In some examples, a valve positioning structure can comprise a first frame 1530 forming a proximal portion of the valve positioning structure, a second frame 1530 forming a distal portion of the valve positioning structure, and an intermediate portion (for example, a plurality of axial struts 536) interconnecting the first and second frames. In some examples, the distal portion of the valve positioning structure can be axially longer than the proximal portion of the valve positioning structure.

[0322] The frame 1530 can comprise a plurality of struts that includes a first plurality of struts 1532 (which are also referred to herein as a “plurality of axial linear struts,” a “plurality of axial struts,” and / or a “plurality of linear struts”) and a second plurality of struts 1534 (which are also referred to herein as a “plurality of serpentine struts” and / or a “plurality of s- struts”). The first plurality of struts 1532 can be arranged into rows 1544, 1548, 1552, 1556 that each extend in a circumferential direction of the frame 1530. Each one of the first plurality of struts 1532 can be oriented at an angle relative to an axial direction of the frame 1530. Each one of the first plurality of struts 1532 can comprise a distal end and a proximalTHVMC-23950W001 end. The distal ends of adjacent ones of the first plurality of struts 1532 can be connected at apices 1583d. The proximal ends of adjacent ones of the first plurality of struts 1532 can be connected at curved or rounded apices 1583p. In some examples, the plurality of struts 1532 can be configured to provide the frame 1530 with structural stiffness and also aid in circumferential expansion of the frame 1530.

[0323] The second plurality of struts 1534 can be arranged into rows 1546, 1550, 1554 that each extend in the circumferential direction of the frame 1530. Each one of the second plurality of struts 1534 can be a strut that forms one or more semicircular turns or curves. For example, as shown, each one of the second plurality of struts 1534 forms four semicircular turns. Each one of the second plurality of struts 1534 can comprise a distal end and a proximal end. The distal end of each one of the second plurality of struts 1534 can be connected to a corresponding one of apices 1583d. The proximal end of each one of the second plurality of struts 1534 can be connected to a corresponding one of apices 1583p.

[0324] In the illustrated example of the frame 1530, rows 1544, 1548, 1552, 1556 of the first plurality of struts 1532 and rows 1546, 1550, 1554 of the second plurality of struts 1534 alternate in the axial direction of the frame 1530. In some examples, alternating rows of the first plurality of struts 1532 and rows of the second plurality of struts 1534 can provide the frame 1530 with desirable mechanical properties. For example, the first plurality of struts 1532 can imbue structural support and / or stiffness to the frame 1530 while the second plurality of struts 1534 (which can more easily elongate in the axial direction than the first plurality of struts 1532) can better allow the frame 1530 to flex and / or elongate. In other examples of the frame 1530, the first plurality of struts 1532 and the second plurality of struts 1534 can be arranged in any number of rows in any configuration (for example, a configuration where the rows of the first plurality of struts 1532 and rows of the second plurality of struts 1534 do not alternate).

[0325] FIG. 22 is a flattened view of a frame 1630 of a valve positioning structure, according to one example. A valve positioning structure of a delivery apparatus can be formed at least in part by shape setting the frame 1630 in a radially compressed state (for example, in the shape of the valve positioning structure 525 shown in FIG. 10A). The frame 1630 can comprise a distal valve positioning portion 1626, a proximal valve positioning portion 1628 proximally disposed relative to the distal valve positioning portion 1626, and the intermediate valve positioning portion 1029 disposed between the distal valve positioning portion 1626THVMC-23950W001 and the proximal valve positioning portion 1628. As shown, the proximal valve positioning portion 1628 and the distal valve positioning portion 1626 have the same structure. In some examples, the distal valve positioning portion 1626 can be axially longer than the proximal valve positioning portion 1628.

[0326] Each of the distal valve positioning portion 1626 and the proximal valve positioning portion 1628 can comprise a plurality of stmts that includes a first plurality of stmts 1632 (which are also referred to herein as a “plurality of axial linear stmts,” a “plurality of axial stmts,” and / or a “plurality of linear stmts”) and a second plurality of stmts 1634 (which are also referred to herein as a “plurality of serpentine stmts,” a “plurality of sinusoidal stmts,” and / or a “plurality of s-stmts”). The first plurality of stmts 1632 can be arranged into rows 1644, 1648, 1652, 1656 that each extend in a circumferential direction of the frame 1630. Each one of the first plurality of stmts 1632 can be oriented at an angle relative to an axial direction of the frame 1630. Each one of the first plurality of stmts 1632 can comprise a distal end and a proximal end. The distal ends of adjacent ones of the first plurality of stmts 1632 can be connected at apices 1683d. The proximal ends of adjacent ones of the first plurality of stmts 1632 can be connected at curved or rounded apices 1683p.

[0327] The second plurality of stmts 1634 can be arranged into rows 1646, 1650, 1654 that each extend in the circumferential direction of the frame 1630. Each one of the second plurality of struts 1634 can be a strut that forms one or more curves. For example, as shown, each one of the second plurality of stmts 1634 forms four alternating curves that each extend less than 180 degrees. Each one of the second plurality of stmts 1634 can comprise a distal end and a proximal end. The distal end of each one of the second plurality of stmts 1634 can be connected to a corresponding one of apices 1683d. The proximal end of each one of the second plurality of stmts 1634 can be connected to a corresponding one of apices 1683p. In this way, the second plurality of stmts 1634 (which are capable of a greater degree of elongation than the first plurality of stmts 1632) can better allow the frame 1630 to expand in its axial direction.

[0328] As shown, each one of the plurality of connecting struts 1065 of the intermediate valve positioning portion 1029 connects each of the proximal-most ones of apices 1683p of the distal valve positioning portion 1626 with a corresponding one of the distal-most apices 1683d of the proximal valve positioning portion 1628.THVMC-23950W001

[0329] FIG. 23 is a flattened view of a frame 1730 of a valve positioning structure, according to one example. A valve positioning structure of a delivery apparatus can be formed at least in part by shape setting the frame 1730 in a radially compressed state (for example, in the shape of the valve positioning structure 525 shown in FIG. 10A). The frame 1730 can comprise a distal valve positioning portion 1726, a proximal valve positioning portion 1728 proximally disposed relative to the distal valve positioning portion 1726, and the intermediate valve positioning portion 1029 disposed between the distal valve positioning portion 1726 and the proximal valve positioning portion 1728. As shown, the proximal valve positioning portion 1728 and the distal valve positioning portion 1726 have the same structure. In some examples, the distal valve positioning portion 1726 can be axially longer than the proximal valve positioning portion 1728.

[0330] The valve positioning portions 1726, 1728 can share certain similarities with the valve positioning portions 1626, 1628 illustrated in FIG. 22. One exemplary difference between the valve positioning portions 1726, 1728 and the valve positioning portions 1626, 1628 is that each of the distal valve positioning portion 1726 and the proximal valve positioning portion 1728 can include a second plurality of struts 1734 instead of the second plurality of struts 1634 illustrated in FIG. 22. As shown, each one of the second plurality of struts 1734 is a curved or serpentine strut that forms four alternating semicircular curves or turns. In this way, the second plurality of struts 1734 (which are capable of a greater degree of elongation than the first plurality of struts 1632) can better allow the frame 1730 to expand in its axial direction. As shown, the second plurality of struts 1734 are arranged into circumferentially extending rows 1746, 1750, 1754. As shown, rows 1746, 1750, 1754 are arranged in an alternating pattern with rows 1644, 1648, 1652, 1656.

[0331] FIG. 24 A is a side view of a distal end portion of a delivery apparatus 1800, according to one example. The delivery apparatus 1800 includes the intermediate shaft 106, the inner shaft 108, the balloon 118, and the nose cone 122. As shown, the balloon 118 is shown in a deflated state. One exemplary difference between the presently illustrated delivery apparatus 1800 and other delivery apparatuses illustrated herein is that the delivery apparatus 1800 includes a valve positioning structure 1825 disposed around the balloon 118. The valve positioning structure 1825 includes a frame 1830, which is further described with respect to FIG. 24C.THVMC-23950W001

[0332] FIG. 24B is a side view of the distal end portion of the delivery apparatus 1800, wherein the balloon 118 is in an inflated state and the valve positioning structure 1825 in a radially expanded state.

[0333] FIG. 24C is a flattened view of the frame 1830 of the valve positioning structure 1825, according to one example. The frame 1830 can comprise a distal valve positioning portion 1826, a proximal valve positioning portion 1828 proximally disposed relative to the distal valve positioning portion 1826, and the intermediate valve positioning portion 1029 disposed between the distal valve positioning portion 1826 and the proximal valve positioning portion 1828. As shown, the proximal valve positioning portion 1828 and the distal valve positioning portion 1826 have the same structure. In some examples, the distal valve positioning portion 1826 can be axially longer than the proximal valve positioning portion 1828.

[0334] The distal valve positioning portion 1826 (and the proximal valve positioning portion 1828) can share certain similarities with distal valve positioning portion 1626 (and the proximal valve positioning portion 1628) illustrated in FIG. 22 and / or the distal valve positioning portion 1726 (and the proximal valve positioning portion 1728) illustrated in FIG. 23. One exemplary difference is that each of the distal valve positioning portion 1826 and the proximal valve positioning portion 1828 can include a second plurality of struts 1834 instead of the second plurality of struts 1634 illustrated in FIG. 22 or the second plurality of struts 1734 illustrated in FIG. 23. As shown, each one of the second plurality of struts 1834 has a zigzag or sawtooth shape that extends in an axial direction of the frame 1830. In this way, the second plurality of struts 1834, which can elongate to a greater degree than the first plurality of struts 1632, can better allow the frame 1830 to expand in its axial direction. In some examples, the second plurality of struts 1834 can elongate to a greater degree than the second plurality of struts 1634 illustrated in FIG. 22. As shown, the second plurality of struts 1834 are arranged into circumferentially extending rows 1846, 1850, 1854 that alternate with rows 1644, 1648, 1652, 1656 of the first plurality of struts 1632.

[0335] FIG. 25 is a flattened view of a portion of a frame 1930 of a valve positioning structure, according to one example. A valve positioning structure of a delivery apparatus can be formed at least in part by shape setting the frame 1930 in a radially compressed state (for example, in the shape of the valve positioning structure 525 shown in FIG. 10A). TheTHVMC-23950W001 illustrated portion can be a distal portion (for example, a distal valve positioning portion) or a proximal portion (for example, a proximal valve positioning portion) of the frame 1930.

[0336] One exemplary difference between the frame 1930 and the frame 1830 illustrated in FIG. 24 is that the illustrated portion of the frame 1930 comprises a plurality of struts including the first plurality of struts 1632, the second plurality of struts 1834, and a third plurality of struts 1934. As shown, each one of the third plurality of struts 1934 is a linear strut oriented in an axial direction of the frame 1930.

[0337] As shown, ones of the second plurality of struts 1834 and ones of the third plurality of struts 1934 are arranged a pattern of struts that extend in a circumferential direction of the frame 1930 and form circumferentially-extending rows 1950, 1954. As shown, each row 1950, 1954 includes three adjacent ones of the second plurality of struts 1834 that alternate with three adjacent ones of the third plurality of struts 1934. In some examples, this alternating pattern of the second plurality of struts 1834 and the third plurality of struts 1934 can provide the resulting valve positioning structure and / or delivery apparatus with a desirable balance of flexibility and axial strength that better allows the delivery apparatus to navigate the patient’s vasculature (for example, the aortic arch).

[0338] FIG. 26 is a flattened view of a frame 2030 of a valve positioning structure, according to one example. A valve positioning structure of a delivery apparatus can be formed at least in part by shape setting the frame 2030 in a radially compressed state (for example, in the shape of the valve positioning structure 525 shown in FIG. 10A). The frame 2030 can comprise a distal valve positioning portion 2026, a proximal valve positioning portion 2028 proximally disposed relative to the distal valve positioning portion 2026, and an intermediate valve positioning portion 2029 disposed between the distal valve positioning portion 2026 and the proximal valve positioning portion 2028. As shown, the proximal valve positioning portion 2028 and the distal valve positioning portion 2026 have the same structure. In some examples, the distal valve positioning portion 2026 can be axially longer than the proximal valve positioning portion 2028.

[0339] Each one of the valve positioning portions 2026, 2028 includes a plurality of struts that includes the first plurality of struts 1632 and a second plurality of struts 2034. The second plurality of struts are arranged into rows 2046, 2050, 2054. One exemplary difference between the second plurality of struts 2034 and, for example, the second plurality of struts 1634 illustrated in FIG. 22 and / or the second plurality of struts 1734 illustrated in FIG. 23 isTHVMC-23950W001 that the second plurality of struts 2034 are arranged such that a portion of each one of the second plurality of struts 2034 overlaps a corresponding portion of a circumferentially adjacent one of the second plurality of struts 2034 when the frame 2030 is the flattened state (shown in FIG. 26) and / or when the frame 2030 is in a radially collapsed state. In this way, the second plurality of struts 2034 can provide the frame 2030 with improved strength when the frame 2030 deforms.

[0340] The intermediate valve positioning portion 2029 can include a plurality of connecting struts 2065 (which are also referred to herein as a “plurality of axial linear connecting struts,” a “plurality of axial connecting struts,” and / or a “plurality of linear connecting struts”). One exemplary difference between plurality of connecting struts 2065 and the plurality of connecting struts 1065 illustrated, for example, in FIGS. 16, 18-20 and 22-24 is that each one of the plurality of connecting struts 2065 can have a longer axial length than each one of the plurality of connecting struts 1065.

[0341] FIG. 27 is a flattened view of a frame 2130 of a valve positioning structure, according to one example. A valve positioning structure of a delivery apparatus can be formed at least in part by shape setting the frame 2130 in a radially compressed state (for example, in the shape of the valve positioning structure 525 shown in FIG. 10A). The frame 2130 can comprise a distal valve positioning portion 2126, a proximal valve positioning portion 2128 proximally disposed relative to the distal valve positioning portion 2126, and the intermediate valve positioning portion 1029 disposed between the distal valve positioning portion 2126 and the proximal valve positioning portion 2128. As shown, the proximal valve positioning portion 2128 and the distal valve positioning portion 2126 have the same structure. In some examples, the distal valve positioning portion 2126 can be axially longer than the proximal valve positioning portion 2128.

[0342] Each one of the distal valve positioning portion 2126 and the proximal valve positioning portion 2128 includes the plurality of struts that includes the first plurality of struts 1632 and the second plurality of struts 2034. One exemplary difference between the valve positioning portions 2126, 2128 and the valve positioning portions 2026, 2028 illustrated in FIG. 26 is that the second plurality of struts 2034 are arranged into circumferentially-extending rows 2146, 2150, 2154, wherein a greater portion of each one of the second plurality of struts 2034 overlaps a corresponding portion of a circumferentially adjacent one of the second plurality of struts as compared to the arrangement shown in FIG.THVMC-23950W00126. In this way, this greater circumferential density of the second plurality of struts 2034 can provide a more continuous interface for interaction with a sheath, a prosthetic valve, and / or the subject’s anatomy.

[0343] FIG. 28 is a flattened view of a portion of a frame 2230 of a valve positioning structure, according to one example. A valve positioning structure of a delivery apparatus can be formed at least in part by shape setting the frame 2230 in a radially compressed state (for example, in the shape of the valve positioning structure 525 shown in FIG. 10A). Alternatively, the illustrated portion of the frame 2230 can be used to form one of a proximal valve positioning structure or a distal valve positioning structure similar to the valve positioning structures shown in FIGS. 5A-5B. The illustrated portion can be a distal portion (for example, a distal valve positioning portion) or a proximal portion (for example, a proximal valve positioning portion) of the frame 2230.

[0344] The illustrated portion of the frame 2230 can include a plurality of struts, including a first plurality of struts 2232, a second plurality of struts 2233, a third plurality of struts 2234, a fourth plurality of struts 2236, a fifth plurality of struts 2238, a sixth plurality of struts 2240, and a seventh plurality of struts 2242. The illustrated portion of the frame 2230 can also include a plurality of axially extending crossbars 2263.

[0345] The first plurality of struts 2232 (which are also referred to herein as a “plurality of axial linear struts,” a “plurality of axial struts,” and / or a “plurality of linear struts”) can be oriented in an axial direction of the frame 2230. The second plurality of struts 2233 (which are also referred to herein as a “plurality of circumferential linear struts,” a “plurality of circumferential struts,” and / or a “plurality of linear struts”) can be oriented in the circumferential direction of the frame 2230. Each one of the plurality of axially extending crossbars 2263 can extend in the axial direction to connect axially adjacent ones of the second plurality of struts 2233. The first and second pluralities of struts 2232, 2233 and the axial crossbars 2263 can be arranged to form a plurality of cross-shaped or “t”-shaped cells 2270 that extend in a circumferentially-extending row. In some examples, the cross-shaped or “t”-shaped cells 2270 can elongate and / or expand in both the circumferential direction and the axial direction to provide the frame 2230 (or at least a portion thereof) with greater flexibility as compared to frames with other arrangements of struts.

[0346] The third plurality of struts 2234 (which are also referred to herein as a “plurality of angled linear struts,” a “plurality of angled struts,” and / or a “plurality of linear struts”) can beTHVMC-23950W001 arranged in a circumferentially-extending row 2246 proximally disposed relative the first and second pluralities of struts 2232, 2233. Each one of the third plurality of struts 2234 can be oriented at an angle relative to the axial direction of the frame 2230.

[0347] The fourth plurality of struts 2236 (which are also referred to herein as a “plurality of serpentine struts,” a “plurality of sinusoidal struts,” and / or a “plurality of s-struts”) can be arranged in a circumferentially-extending row 2248 proximally disposed relative to row 2246.

[0348] The fifth plurality of struts 2238 (which are also referred to herein as a “plurality of angled linear struts,” a “plurality of angled struts,” and / or a “plurality of linear struts”) can be arranged in a circumferentially-extending row 2250 that is proximally disposed relative to row 2248.

[0349] The sixth plurality of struts 2240 (which are also referred to herein as a “plurality of serpentine struts,” a “plurality of sinusoidal struts,” and / or a “plurality of s-struts”) can be arranged in a circumferentially-extending row 2252 proximally disposed relative to row 2250.

[0350] The seventh plurality of struts 2242 (which are also referred to herein as a “plurality of angled linear struts,” a “plurality of angled struts,” and / or a “plurality of linear struts”) can be arranged in a circumferentially-extending row 2254 that is proximally disposed relative to row 2252.

[0351] FIG. 29A is a side view of a distal end portion of a delivery apparatus 2300, according to one example. The delivery apparatus 2300 includes the intermediate shaft 106, the inner shaft 108, the balloon 118, and the nose cone 122. As shown, the balloon 118 is shown in a deflated state. One exemplary difference between the presently illustrated delivery apparatus 2300 and other delivery apparatuses illustrated herein is that the delivery apparatus 2300 includes a valve positioning structure 2325 disposed around the balloon 118. The valve positioning structure 2325 includes a frame 2330, which is further described with respect to FIG. 29C.

[0352] When the balloon 118 is in the deflated state and the valve positioning structure 2325 is in a radially collapsed state, the valve positioning structure 2325 prevents the prosthetic valve 150 from contacting the balloon 1 18. Furthermore, no portion of the valve positioning structure 2325 overlaps the outer surface of the prosthetic valve 150.THVMC-23950W001

[0353] FIG. 29B is a side view of the distal end portion of the delivery apparatus 2300, wherein the balloon 118 is in an inflated state and the valve positioning structure is in a radially expanded state.

[0354] FIG. 29C is a flattened view of a portion of the frame 2330 of the valve positioning structure 2325, according to one example. The illustrated portion can be a distal portion (for example, a distal valve positioning portion) or a proximal portion (for example, a proximal valve positioning portion) of the frame 2330.

[0355] One exemplary difference between the portion of the frame 2330 and the portion of the frame 2230 illustrated in FIG. 28 is that the frame 2330 comprises a first plurality of struts 2332 (which are also referred to herein as a “plurality of angled linear struts,” a “plurality of angled struts,” and / or a “plurality of linear struts”) instead of the first and second pluralities of struts 2232, 2233. The first plurality of struts 2332 can be arranged in a circumferentially-extending row 2344. The row 2344 can be distally disposed relative to row 2246 of the third plurality of struts 2234. In some examples, the first plurality of struts 2332 and the third plurality of struts 2234 can form a plurality of diamond-shaped cells 2370. In some examples, the plurality of diamond-shaped cells 2370 can keep pleats of a balloon of a resulting delivery apparatus (for example, any one of balloons 118, 218, 318, 418) folded when the balloon is in the deflated state.

[0356] Turning to FIGS. 30-37B, additional exemplary polymeric coatings for valve positioning structures (such as, for example, one or more of the exemplary valve positioning structures illustrated FIGS. 3-29C) and exemplary methods of forming a polymeric coating on a valve positioning structure are shown and described. In some examples, a support structure for a valve positioning structure can be at least one of a frame or a braided or woven wire mesh (also referred to herein as a “mesh structure” ). In some examples, a polymeric coating can be formed on the frame of the valve positioning structure. In some examples, a polymeric coating can be formed on a mesh structure of the valve positioning structure. As discussed above, in some examples, a polymeric coating can form a liner or layer of material on the inner surface of a frame or mesh structure, the outer surface of a frame or mesh structure, or both the inner surface and outer surface of a frame or mesh structure. In some examples, a frame or mesh structure can be encapsulated with a polymeric coating. In some examples, a polymeric coating can be formed on only a selected portion or selected portions of a frame or a mesh structure.THVMC-23950W001

[0357] In some examples, the struts of a frame or the wires of a mesh structure can include a polymeric coating over their interior and exterior surfaces, and the cells between the struts or wires can be uncoated and open (referred to herein as an “open-cell polymeric coating’'). The term “open-cell polymeric coating” as used herein refers to the fact that the coating does not span the opening of a cell and therefore the opening of the cell remains open or unobstructed by the coating. The term “open-cell polymeric coating” as used herein does not refer to the type of polymer used to form the coating, such as an open-cell foam (although such materials could be used to form the polymer coating). In some examples, such as in the polymeric coating 275 on the frame 230 shown in FIGS. 6A and 6B, the polymeric coating can span across the cells of the frame or mesh structure, thereby forming a webbing portion within the cells (referred to herein as a “closed-cell polymeric coating”). The term “closed-cell polymeric coating” as used herein refers to the fact that the webbing portion spans the opening of a cell and therefore closes or fills the opening of the cell. The term “closed-cell polymeric coating” as used herein does not refer to the type of polymer used to form the coating, such as a closed-cell foam (although such materials could be used to form the polymer coating). In some examples, one more of the interior or exterior layers of polymeric coating can be formed prior to forming the webbing portion. In some examples, one or more of the interior or exterior layers of polymeric coating can be formed simultaneously with the webbing portion.

[0358] FIG. 30 is a flow diagram illustrating an exemplary method 3000 of forming an opencell polymeric coating on a frame and / or on a mesh structure. As shown at step 3002, optionally, one or more portions of the frame or mesh structure can be masked (for example, covered by a masking material) so that the polymeric coating can be formed on only a selected portion or selected portions of the frame or mesh structure. For example, as shown in FIG. 31, for forming a polymeric coating on a portion of the frame 530 (which is described above with respect to FIGS. 10A-10E), first and second end regions 3012, 3014 can be covered with masking material 3016 to mask the struts of the frame 530 in the first and second end regions. The masking material 3016 can be applied to the inner surface and / or the outer surface of the fame 530 within the regions 3012, 3014. A center region 3018 of the frame 530 can remain exposed and / or uncovered by the masking material. In some examples, the center region 3018 includes a portion of the proximal valve positioning portion 528, a portion of the distal valve positioning portion 526, and the intermediate valve positioningTHVMC-23950W001 portion 529. In some examples, the masked regions and the exposed region can vary from the illustrated example. For example, a center portion can be masked and one or more end regions can be exposed. In the example shown in FIG. 31, as polymeric material is applied to the frame 530 (for example, at step 3004 and / or at steps 3006 and 3008, discussed below), the polymeric coating can be formed on the struts of the frame in the exposed center region 3018. The center region 3018 corresponds a section of the valve positioning structure 525 most likely to come in contact with a prosthetic valve that is crimped around the valve positioning structure. At the first and second end region 3012, 3014, the polymeric material can be applied to the outer surface of the masking material 3016 (depending on the process used to apply the coating to the frame), while the underlying struts remain free of the polymeric coating. In some examples, exemplary masking materials can include tape, such as PTFE tape or similar materials.

[0359] Per step 3004, in a first example of forming an open-cell polymeric coating, the frame or mesh structure (whether masked or unmasked) can be spray coated with a polymeric material. In some examples, the interior and exterior surfaces of the struts or wires can be ultrasonic spray coated to form a thin polymer film layer thereon without producing a webbing portion within the cells of the frame or mesh structure. In some examples, interior and exterior surfaces of the struts or wires can be spray coated while the frame or mesh structure is in a radially collapsed state. In some examples, the frame 530 can be spray coated while the frame is in the radially collapsed state shown in FIG. 10A (without masking) and / or in the radially collapsed state shown FIG. 31 (with masking). In some examples, the braided wire mesh structure 430 can be spray coated while it is in the radially collapsed state shown in FIG. 9 A. In some examples, the frame or mesh structure (whether masked or unmasked) can be spray coated with a polymeric material while in a partially expanded state or a fully expanded state.

[0360] Steps 3006, 3008 show a second example of forming an open-cell polymeric coating. First, the frame or mesh structure (whether masked or unmasked) can be dipped in a liquid polymeric material (step 3006). In some examples, the frame or mesh structure can be dipped while it is in a radially collapsed state. In some examples, the frame 530 can be dipped into a liquid polymeric material while the frame is in the radially collapsed state shown in FIG. 10A (without masking) and / or in the radially collapsed state shown in FIG. 31 (with masking). In some examples, the braided wire mesh structure 430 can be dipped whileTHVMC-23950W001 it is in the radially collapsed state shown in FIG. 9A. In some examples, the frame or mesh structure (whether masked or unmasked) can be dip-coated while in a partially expanded state or a fully expanded state. In some examples, the dipping process will temporarily form a webbing portion within the cells of the frame or mesh structure. At step 3008, the webbing portion within the cells can be removed, leaving the struts coated with the polymer. In some examples, the webbing can be cut out of the cells using a cutting tool, such as a laser, knife or a scalpel.

[0361] Steps 3009, 3011, 3013 show a third example of forming an open-cell polymeric coating. First, a blocking structure can be engaged with the frame or mesh structure by, for example, inserting portions of the blocking structure into and / or through cells of the frame or mesh structure (whether masked or unmasked) (step 3009). In some examples, a blocking structure can have a complementary and / or negative shape relative to the frame or mesh structure. For example, a blocking structure can include a main body having raised portions (for example, projections, protrusions, or other raised portions) extending therefrom that correspond to the locations and shapes of the cells of the frame. In some examples, the raised portions can extend into and block at least a portion of the open spaces of the cells of the frame. In some examples, the raised portions can be the same size or substantially the same size as the corresponding cells so that the exterior walls or edges of each raised portion contacts the interior edges of the struts forming the respective cell. In some examples, the raised portions can be smaller than the corresponding cells so that there is a gap between the interior edges of the struts forming the respective cells and the exterior walls or edges of the raised portions.

[0362] For example, FIGS. 37A and 37B illustrate front and side views of a portion of an exemplary blocking structure 3600 that can be used for forming an open-cell polymeric coating on the frame 530. As can be seen therein, raised portions 3604a-3604e can extend from a main body 3602 of the blocking structure 3600. The raised portions 3604a-3604e can have a complementary and / or negative shape relative to the cells of the frame 530 so that the raised portions can be inserted through the respective corresponding cells. For example, the raised portion 3604a can have a complementary and / or negative shape relative to the cell 574 formed by struts 571 .

[0363] In some examples, the raised portion 3604a can be smaller than the open space 573 so that a gap 3606 is formed between an exterior edge of the raised portion 3604a and theTHVMC-23950W001 interior edges of the struts 571. In some examples, the main body 3602 can be disposed inside of the frame 530 and the raised portions 3604a-3604e can extend through the cells of the frame 530 from the interior of the frame to the exterior. In some examples, the main body 3602 can be disposed outside of the frame 530 and the raised portions 3604a-3604e can extend through the cells of the frame 530 from the exterior of the frame to the interior. In some examples, the main body 3602 of the blocking structure 3600 can be abutted to the interior or exterior surface of the frame 530 while the raised portions 3604a-3604e extend through the cells. In some examples, a gap can be disposed between the main body 3602 and the interior or exterior surface of the frame while the raised portions 3604a-3604e extend through the cells.

[0364] After insertion of the raised portion into and / or through the cells, the frame or mesh structure can be dip coated and / or spray coated (step 3011). The raised portions 3604a-3604e prevent the formation of webbing within the cells and allow the exposed surfaces of the struts to be coated in the polymer. For example, if the blocking structure is placed inside of the frame 530 and the raised portions 3604a-3604e extend through the cells from the inside of the frame, the outer surface of the struts can be coated in the polymer without the formation of webbing in the cells. The gaps 3606 can allow the polymer to coat the sides of the struts that extend from the inner surface to the outer surface of the frame. In some examples, the main body 3602 of the blocking structure 3600 is positioned such that there are gaps between the inner surfaces of the struts and the opposing surface of the main body 3602. This can allow the polymer to flow underneath the struts (in the gaps between the inner surfaces of the struts and the main body 3602) and coat the inner surfaces of the struts. In this manner, all sides of the struts can be coated at the same time.

[0365] In some examples, the main body of the blocking structure can correspond to a shape of and / or have a diameter equal to the frame or mesh structure while it is in a radially collapsed state. For example, the frame 530 and the blocking structure 3600 (engaged therewith) can be dipped into a liquid polymeric material or spray coated with a polymeric material while the frame is in the radially collapsed state shown in FIG. 10A (without masking) and / or in the radially collapsed state shown in FIG. 31 (with masking). In another example, the braided wire mesh structure 430 and a blocking structure (complementary thereto and engaged therewith) can be dipped while it is in the radially collapsed state shown in FIG. 9A. In some examples, the frame or mesh structure engaged with a complementaryTHVMC-23950W001 blocking structure can be spray coated with a polymeric material while in a partially expanded or a fully expanded state. In such examples, the blocking structure can correspond to a shape of and / or have a diameter equal to the frame or mesh structure while it is in a partially expanded state or a fully expanded state.

[0366] At step 3013, the blocking structure can be disengaged from the frame or mesh structure (for example, the raised portions can be withdrawn from the cells and the main body can be removed from the interior or exterior of the frame). If only one side of the frame is coated at step 3011, this process can be repeated for the other side of the frame. For example, if the block structure 3600 is first placed inside the frame to coat the outer surface of the frame, that block structure is removed and a blocking structure can be placed on the outside of the frame and the inside of the struts can be coated with the polymer. In some examples, one or more surfaces of the frame or mesh structure can be spray coated with a polymeric material after the blocking structure is disengaged from the frame or mesh structure, for example, to fill in any uncoated surfaces.

[0367] FIG. 32A shows an exemplary detailed view of a portion the frame 530 having thin layer polymer coating 575 disposed on individual struts 571 of the frame, which can be formed via the method 3000. As can be seen in FIG. 32A, the struts 571 form a cell 574 enclosing a space 573, which is open and uncoated. In other words, the space 573 of the cell 574 is free of the polymer coating 575 and only the struts 571 are coated by the polymeric material. FIG. 32B shows a cross-section of one of the struts 571 taken along the line 32B- 32B shown in FIG. 32A. As can be seen therein, in some examples, each of the individual struts 571 is encapsulated and / or enclosed on all sides by the polymeric coating 575. In some examples, the polymeric coating 575 can be disposed on surfaces of the struts 571 that form the inner surface and the outer surface of the frame 530. In some examples, the interior edges of the struts 571 can be uncoated.

[0368] Returning to FIG. 30, in examples including masking, after the polymeric material has been applied (via the methods discussed above), the masking material 3016 can be removed from the frame or mesh structure (step 3010). In the example of FIG. 31, after the masking material is removed from the frame 530, the frame can have an open-cell polymeric coating in just the center portion 3018 of the frame 530 while the opposing end regions 3012 and 3014 are uncoated. In examples excluding masking, the entirety (or at least a majority) of the frame or mesh structure can include an open-cell polymeric coating. The frame orTHVMC-23950W001 mesh structure having the open-cell polymeric coating can then be utilized in assembly of a distal portion of a delivery apparatus, such as, for example, the distal end portions of one or more of the delivery apparatuses 100, 200, 300, 400, 500, 600, 1400, 1800, 2300.

[0369] As the exemplary open-cell polymeric coatings exclude a webbing portion, the frames and / or the mesh structures including an open-cell polymeric coating can freely move between a radially collapsed state and a radially expanded state without any risk of tearing or damaging the webbing of the polymeric coating due to over-stretching when the frame is radially expanded and / or crushing, folding, and / or wrinkling of the webbing when the frame is radially collapsed. In this way, a wider variety of materials — for example, polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (ePTFE), ethylene tetrafluoroethylene (ETFE), nylon, polyethylene (such as, for example, low-density polyethylene (LOPE), high density polyethylene (HOPE)), polyether block amide (for example, Pebax), bi-oriented polypropylene, cast polypropylene, thermoplastic, polyurethane, ultra-high-molecular-weight polyethylene (UHMWPE) (for example, Dyneema®), high- molecular-weight polyethylene (HMWPE), or polyether ether ketone (PEEK), and / or combinations of any of the above - can be utilized to form an open-cell polymeric coating.

[0370] In some examples, closed-cell polymeric coatings can include a webbing portion which is formed in a manner that limits undesired over-stretching and / or tearing when a frame or mesh structure is radially expanded. In some examples, closed-cell polymeric coatings can include a webbing portion which is formed in a manner that limits undesired crushing, folding, and / or wrinkling when the frame or mesh structure is radially collapsed. In some examples, methods for closed-cell polymeric coatings can include forming a first layer of polymer coating in a first step and forming a second layer of polymer coating in a second step. In some examples, forming the webbing portion the polymeric coating can occur at the first step. In some examples, forming the webbing portion the polymeric coating can occur at the second step. In some examples, forming the webbing portion the polymeric coating can occur while the frame is an at least partially expanded state.

[0371] FIG. 33 is a flow diagram illustrating an exemplary method 3020 of forming a closed-cell polymeric coating on a frame and / or on a mesh structure. As shown at step 3022, optionally, one or more portions of a frame or mesh structure can be masked (that is, covered by a masking material) to help ensure that the polymeric coating is applied to only a selected portion or selected portions of the frame or mesh structure. In some examples, masking canTHVMC-23950W001 be carried out as discussed above with respect to step 3002 of FIG. 30 and / or as illustrated in FIG. 31. In some examples, masking can be carried out in a first masking step while the frame or mesh structure is in a radially compressed state, and a second masking step while the frame or mesh structure is in an at least partially expanded state (for example, after mounting of the frame or mesh structure onto a retaining device at step 3026, discussed below).

[0372] Next, the method 3020 can include forming a first layer of polymer (step 3024), mounting the frame or mesh structure onto a retaining device so that the frame or mesh structure is retained in an at least partially expanded state (step 3026), forming a second layer of polymer while the frame or mesh structure is retained in an at least partially expanded state (step 3028), and then bonding the first and second layers of polymer to form a polymeric coating (step 3030). Exemplary techniques for forming and bonding the first layer second layers of polymer are discussed below.

[0373] In some examples, forming the first layer of polymer (step 3024) can include one or more steps that are similar to the method 3000 described above for forming an open-cell polymeric coating. For example, in some examples, forming the first layer of polymer can include spray coating the interior and exterior surfaces of struts or wires while the frame or mesh structure is in a radially collapsed state. In some examples, forming the first layer of polymer can include spray coating only the interior of struts or wires while the frame or mesh structure is in a radially collapsed state. In some examples, forming the first layer of polymer can include dipping the frame or mesh structure into a liquid polymer while it is in a radially collapsed state and then removing a webbing portion of the polymeric coating from the cells. In some examples, forming the first layer of polymer can include dip coating or spray coating the frame or mesh structure while it is engaged with a blocking structure. Each of the above examples can result in a polymeric coating over at least the interior surfaces or exterior surfaces of struts or wires with the cells of the frame or mesh structure being open (without webbing).

[0374] In some examples, forming the first layer of polymer (step 3024) can include applying one or more layers of polymer material to an exterior surface of a retaining device, such as a mandrel or a balloon, onto which the frame or mesh structure will be mounted. For example, the exterior surface of the retaining device can be dipped in a liquid polymer, the exterior surface can be spray coated with a polymeric material, and / or a film of polymericTHVMC-23950W001 material can be separately formed and then wrapped over or otherwise disposed on the exterior surface of the retaining device prior to mounting the frame or mesh structure on the retaining device. For example, FIG. 34 illustrates an exemplary retaining device 3036 in the form of a balloon of a balloon catheter, wherein a layer of polymeric material 3038 is disposed on an exterior surface 3040 of the retaining device. In some examples, the layer of polymeric material 3038 can be applied to the exterior surface 3040 of the retaining device 3036 prior to positioning a frame or mesh structure 3130 onto the retaining device.

[0375] After forming the first layer of polymer at step 3024, the method 3020 can include mounting the frame or mesh structure on a retaining device so that the frame or mesh structure is retained in an at least partially expanded state (step 3026). In some examples, the frame or mesh structure can be mounted on the retaining device in a fully expanded state. In some examples, the frame or mesh structure can be mounted on the retaining device in a partially expanded state. In some examples, the retaining device can have an outer diameter and / or a shape that corresponds to an inner diameter and / or shape of the frame or mesh structure in the at least partially radially expanded state.

[0376] In some examples, the retaining device can be a mandrel. In some examples, the mandrel can be selected to have an outer diameter and / or shape corresponding to the frame in a fully expanded state (for example, an outer diameter and / or shape corresponding to the fully expanded state of the frame 530 FIG. 10E, or the fully expanded state of the mesh structure 430 shown in FIG. 9C). In some examples, the mandrel can be selected to have an outer diameter and / or shape corresponding to the frame or mesh structure in a partially expanded state (for example, an outer diameter and / or shape corresponding to the frame 530 can be in a partially expanded state that is intermediate relative to the collapsed state of FIG. 10D and the fully expanded state of FIG. 10E, or the partially expanded state of the braided mesh 430 shown in FIG. 9B).

[0377] In some examples, the retaining device can be a balloon. In some examples, the balloon can be inflated to have an outer diameter and / or shape corresponding to the frame in a fully expanded state (for example, an outer diameter and / or shape corresponding to the fully expanded state of the frame 530 FIG. 10E, or the fully expanded state of the mesh structure 430 shown in FIG. 9C). In some examples, the balloon can be inflated to have an outer diameter and / or shape corresponding to the frame or mesh structure in a partially expanded state (for example, an outer diameter and / or shape corresponding to the frame 530 can be in aTHVMC-23950W001 partially expanded state that is intermediate relative to the collapsed state of FIG. 10D and the fully expanded state of FIG. 10E, or the partially expanded state of the mesh structure 430 shown in FIG. 9B).

[0378] After mounting the frame or mesh structure on the retaining device in the at least partially expanded state at step 3026, the method 3020 can include forming a second polymer layer (step 3028). In some examples, forming the second layer of polymer can include dipping the frame or mesh structure mounted on the retaining device into a liquid polymer. In some examples, forming the second layer of polymer can include wrapping or otherwise disposing one or more layers of polymeric film over the frame or mesh structure mounted on the retaining device. In some examples, forming the second layer of polymer can include spray coating the frame or mesh structure mounted on the retaining device with a polymer material.

[0379] In examples where the forming of the first polymer layer includes spray coating the frame or mesh structure or dip coating and removing the webbing portion from the frame or mesh structure, a liquid polymer or a polymer film forming the second layer can form an additional layer of polymer over the exterior surfaces of the struts or wires and can form a webbing portion of the polymer coating. In examples where the forming of the first polymer layer includes applying a layer of polymer to the exterior surface of the retaining device, a liquid polymer, a polymer film, or spray coated polymer forming the second layer can form a layer of polymer over the exterior surfaces of the struts or wires and can form an additional layer of the webbing portion of the polymer coating.

[0380] In the example of FIG. 34, the frame or mesh structure 3130 can be mounted on the retaining device 3036 so that it extends over the polymeric material 3038 applied to the exterior surface 3040 of the retaining device and the polymeric material 3038 (first layer) contacts the interior surfaces of the struts or wires of the frame or mesh structure 3130. In some examples, a second layer of polymeric material 3042 (which can be formed by one or more of dip coating, spray coating, or wrapping a sheet of polymeric material over the frame or mesh structure 3130) can coat the exterior surfaces of the struts or wires of the frame or mesh structure 3130 and overlap with the underlying layer 3038 within the cells and / or at the inflow and outflow edges of the frame or mesh structure 130.

[0381] After forming the second layer of polymer at step 3028, the method 3020 can include bonding and / or fusing the first and second polymer layers (step 3030). In some examples, theTHVMC-23950W001 first and second polymer layers can be bonded and / or fused via heating the assembly or layup of the frame or mesh structure and layers 3038, 3042 at a temperature sufficient to partially melt or bring the polymer to a semi-solid and / or molten state so that the first and second layers can fuse. In some examples, pressure can be applied to the second layer 3042 to compress the second layer 3042 against the frame / mesh structure 3130 and the first layer 3038 while heating the assembly. The temperature, pressure, and / or a duration of the bonding process can be selected based on the type of material forming the first and second polymer layers. In some examples where the forming of the second layer of polymer includes dipping the frame or mesh structure mounted on the retaining device into a liquid polymer, the second layer can be bonded and / or fused to the first layer as the liquid polymer solidifies.

[0382] In some examples, the fusion and / or bonding of the first and second layers of polymeric coating results in forming of a closed-cell polymeric coating encapsulating the struts or wires structure and a webbing portion spanning across the cells of the frame or mesh. For example, the first and second polymer layers 3038, 3042 shown in FIG. 34 can be fused and / or bonded over the frame or mesh structure 3130 mounted on the retaining device 3036 such that encapsulating the stmts or wires structure and webbing spanning across the cells of the frame or mesh, thereby forming a closed-cell polymeric coating 3175.

[0383] After bonding of the first and second polymer layers at step 3032, the frame or mesh structure including the closed-cell polymeric coating can be removed from the retaining device (step 3032) and masking material (if present) can be removed from the frame or mesh structure (step 3034). In some examples, after the polymeric coating is formed, the frame or mesh structure can be removed from the retaining device and allowed to radially collapse back to the radially collapsed state under its own resiliency, thereby radially collapsing the polymeric coating. The frame or mesh structure having the closed-cell polymeric coating can then be utilized in assembly of a distal portion of a delivery apparatus, such as, for example, the distal end portions one or more of the delivery apparatuses 100, 200, 300, 400, 500, 600, 1400, 1800, 2300.

[0384] As discussed above, in some examples, at least the webbing portion of a closed-cell polymeric coating can be formed on a frame or mesh structure when it is in an at least partially radially expanded state. Forming the webbing portion of the polymeric coating when the frame or mesh structure is in one of a semi-expanded state or a fully expanded state,THVMC-23950W001 as opposed to a radially collapsed state, can beneficially reduce the extent to which the polymeric coating stretches as the frame or mesh structure is expanded from a radially collapsed state to a radially expanded state, which in turn can prevent and / or limit tearing of the webbing portion when the frame or mesh structure is expanded from the radially collapsed state to the radially expanded state. In this way, a wider variety of materials — for example, polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (ePTFE), ethylene tetrafluoroethylene (ETFE), nylon, polyethylene (such as, for example, low-density polyethylene (LOPE), high density polyethylene (HOPE)), polyether block amide (for example, Pebax), bi-oriented polypropylene, cast polypropylene, thermoplastic, polyurethane, ultra-high-molecular- weight polyethylene (UHMWPE) (for example, Dyneema®), high- molecular-weight polyethylene (HMWPE), or polyether ether ketone (PEEK), and / or combinations of any of the above - can be utilized to form the closed-cell polymeric coating.

[0385] In some examples, forming the webbing portion of the polymeric coating when the frame or mesh structure is in a partially expanded state, as opposed to a fully expanded state, can beneficially reduce the bulk and / or width of the webbing portion within each of the cells and can thereby reduce undesired wrinkling and folding of the webbing portion when the frame or mesh structure is in the radially collapsed state. In some examples, the reduced bulk of the webbing portion can reduce the overall crimp profile of the distal end of the delivery apparatus (including, for example, a balloon and a valve positioning structure having a prosthetic heart valve crimped there around).

[0386] In some examples, such as those discussed above, the frame or mesh structure can be shape set in the radially collapsed state and can remain in and / or revert to the radially collapsed state under its own resiliency. In some examples, frames or mesh structures having configurations similar to those shown in FIGS. 3-29C can be shape set in an at least partially expanded state (for example, shape set in a partially expanded state or shape set in a fully expanded state). In some examples, frames or mesh structures having configurations similar to those shown in FIGS. 3-29C can be formed from a plastically expandable metal that is radially expandable and collapsable but is non-resilient.

[0387] In some examples, an open-cell polymeric coating can be formed on a frame or mesh structure shape-set in an at least partially expanded state and / or on a frame or mesh structure formed from a plastically expandable metal via the method 3000 discussed above. In some examples, a closed-cell polymeric coating can be formed on a frame or mesh structure shape-THVMC-23950W001 set in an at least partially expanded state and / or on a frame or mesh structure formed from a plastically expandable metal via the method 3020 discussed above. In some examples, a closed-cell polymeric coating for a frame or mesh structure that is shape set in an at least partially expanded state and / or on a frame or mesh structure formed from a plastically expandable metal can be formed via other methods, for example, by dip coating the frame or mesh structure while it is in an at least partially expanded state and leaving the webbing portion of the polymeric coating intact (rather than removing the webbing portion as in the method 3000).

[0388] As described above, a valve positioning structure that include a frame or mesh structure that is shape-set in a radially collapsed state can be mounted over a balloon (for example, the balloon 118) and can remain in the collapsed state on the balloon under its own resiliency until the balloon is expanded. After the balloon is deflated, the valve positioning structure can revert to the radially collapsed state under its own resiliency for retrieval of the delivery apparatus 100 from the patient’s vasculature. In exemplary valve positioning structures including a frame or mesh structure that is shape-set in an at least partially expanded state or a frame or mesh structure formed from a plastically expandable metal, methods and apparatus for mounting the valve positioning structure and / or methods and apparatus for retrieval can vary from the valve positioning structures that include frame or mesh structures that are shape-set in the radially collapsed state.

[0389] In some examples, a valve positioning structure including either a frame or mesh structure that is shape-set in an at least partially expanded state or a frame or mesh structure formed from a plastically expandable metal can be crimped via a crimping device over a catheter balloon (for example, the balloon 118). For example, the valve positioning structure can be mounted in the at least partially expanded state around the catheter balloon and then crimped from the at least partially expanded state to a radially compressed state. In some examples, the valve positioning structure can then be heat treated such that folds or adjacent portions of the polymeric coating on the frame or mesh structure may partially melt or fuse to retain the crimped configuration of the valve positioning structure over the catheter balloon. In some examples, the valve positioning structure can be crimped over the catheter balloon together with a prosthetic heart valve (for example, the prosthetic heart valves 10, 150). In some examples, the crimped prosthetic heart valve can retain the valve positioning structure in the radially compressed state. In some examples including valve positioning structuresTHVMC-23950W001 including a frame or mesh structure that is shape-set in an at least partially expanded state, a sleeve or sheath can be extended over the valve positioning structure after it has been crimped around the balloon and prior to crimping of the prosthetic valve. In some examples, the sleeve or sheath can be temporarily positioned around the valve positioning structure to retain the valve positioning structure in an at least partially compressed state. In some examples, the prosthetic valve can be positioned around the retained valve positioning structure and the sheath can be withdrawn prior to crimping the valve heart valve around the valve positioning structure and balloon.

[0390] After the prosthetic heart valve is crimped onto a distal end portion of a delivery apparatus, the distal end portion of the delivery apparatus can be inserted through a patient’s vasculature to deliver the prosthetic heart valve to a target implantation location. In some examples, the balloon can be inflated to cause radial expansion of the prosthetic heart valve and the valve positioning structure. In examples where the frame or mesh structure of the valve positioning structure includes either a frame or mesh structure that is shape-set in an at least partially expanded state or a frame or mesh structure formed from a plastically expandable metal, after inflation of the balloon and radial expansion of the prosthetic heart valve the valve positioning structure may remain in an at least partially expanded state. In such examples, the valve positioning structure can be configured to be retracted at least partially into a shaft (for example, the outer shaft 104 or a separate valve retrieval shaft) of a delivery apparatus (for example, the delivery apparatus 100). In some examples, an additional transcatheter tool can be used to radially collapse the valve positioning structure prior to its retraction into the shaft. In some examples, the valve positioning structure can be partially or fully retracted into the shaft of the delivery apparatus, which can result in the valve positioning structure collapsing from the radially expanded state to the radially compressed state. In this way, the valve positioning structures can be retracted and retrieved form the patient’s vasculature after the prosthetic heart valve has been deployed.

[0391] In some examples, a valve positioning structure including a mesh structure, such as, for example, the valve positioning structure 425 including the braided mesh structure 430 shown in FIGS. 9A-9C, can include an elastic layer disposed radially outward of the mesh structure. The elastic layer can he configured to radially collapse the valve positioning structure as the balloon deflates to return the valve positioning structure to its collapsed stateTHVMC-23950W001 for retrieval through the patient’s vasculature. In such examples, the valve positioning structure can include a closed-cell polymeric coating.

[0392] For example, a cross-section of a portion of an exemplary valve positioning structure 3100 is shown in FIGS. 35 A and 35B. Although only shown in cross-section, the valve positioning structure 3100 can have a configuration similar to one or more others of the valve positioning structures disclosed herein, such as, for example, the valve positioning structure 425 shown in FIGS. 9A-9C or others of the valve positioning structure disclosed herein. As illustrated in FIG. 35 A, the valve positioning structure 3100 can include a first polymeric layer 3102 (also referred to as an inner layer or an inner liner) (which can comprise any of the polymers described above for forming the coatings in FIGS. 30-34), a braided or woven mesh structure 3104 disposed around and radially outward of the first layer 3102, an elastic layer 3106 disposed around and radially outward of the mesh structure 3104, and a second polymeric layer 3108 (also referred to as an outer layer or an outer liner) (which can comprise any of the polymers described above for forming the coatings in FIGS. 30-34) disposed around and radially outward of the elastic layer 3106. In the illustrated configuration, the inner layer (liner) 3102 can define the lumen 3112 of the valve positioning structure 3100 extending along a central axis 3114. The lumen 3112 can receive a ballon (such as, for example the balloon 118). In some examples, the inner layer (liner) 3102 and / or the outer layer (liner) 3108 can comprise a relatively thin layer of polymeric material. In some examples, the inner liner and the outer liner each can comprise two or more layers of polymeric material. In some examples, the polymeric material can be one or more of the exemplary materials discussed above.

[0393] The elastic layer 3106 can be a resilient, elastic material layer. In some examples, the elastic layer 3106 can be configured to apply force to the underlying layers 3102 and 3104 in a radial direction (for example, toward the central axis 3114 of the sheath) when the valve positioning structure expands beyond its natural diameter, for example, when the ballon is inflated. Stated differently, the elastic layer 3106 can be configured to apply encircling pressure to the layers of the beneath the elastic layer 3106 to counteract expansion of the valve positioning structure 3100. The radially inwardly directed force can be sufficient to cause the valve positioning structure 3100 to collapse radially back to its unexpanded state, for example, after the balloon is deflated. In some examples, the elastic layer 3106 can comprise one or more members configured as strands, ribbons, or bands helically wrappedTHVMC-23950W001 around the mesh structure 3104. In some examples, the elastic layer 3106 can have other forms, such as a tubular layer comprising an elastomeric material, a mesh, a shrinkable polymer layer such as a heat-shrink tubing layer, etc. In some examples, the elastic layer 3106 can be made from, for example, one or more of a variety of natural or synthetic elastomers, including silicone rubber, natural rubber, any of various thermoplastic elastomers, polyurethanes such as polyurethane siloxane copolymers, urethane, plasticized polyvinyl chloride (PVC), styrenic block copolymers, polyolefin elastomers, etc. In some examples, the elastic layer 3106 can be optional. In other words, the elastic layer 3106 can be excluded from the valve positioning structure 3100. In some examples, additional layers can be included in the valve positioning structure.

[0394] FIG. 35B illustrates the layers 3102-3108 of the valve positioning disposed on a mandrel 3118 for forming the valve positioning structure 3100. In some examples, the mandrel 3118 can have a diameter that is greater than the desired natural outer diameter of the finished valve positioning structure in its resting state when no forces are applied thereto. In some examples, the mesh structure 3104 can be formed (e.g., woven or braided) so as to have a resting state corresponding to the radially collapsed of the valve positioning structure. For example, mesh structure 3104 can be formed to have a shape similar or the same as that of the mesh structure 425 in its collapsed state shown in FIG. 9A, but does not require heat setting the wires to retain the mesh structure 3104 in the collapsed state. The mandrel 3118 can be sized to retain the mesh structure 3104 in at least a partially expanded (e.g., similar to the partially expanded state shown in FIG. 9B), a fully expanded state (e.g., similar to the fully expanded state shown in FIG. 9C), or an overexpanded state (e.g., having a diameter greater than that shown in FIG. 9C). In some examples, the outer surface of the mandrel 3118 can have a size and / or shape corresponding to the size and shape of mesh structure in the partially expanded state, fully expanded state, or overexpanded state.

[0395] The valve positioning structure 3100 can be made by wrapping or situating an ePTFE layer 3120 around the mandrel 3118, followed by the first polymeric layer 3102. In some examples, the ePTFE layer 3120 can aid in removing the valve positioning structure 3100 from the mandrel 3118 upon completion of the fabrication process. The first polymeric layer 3102 may be in the form of a pre-fabricated sheet that is applied by being wrapped around the mandrel 3118 or may be applied to the mandrel by dip coating, electro-spinning, etc. The mesh structure 3104 can be situated around the first polymeric layer 3102, followed by theTHVMC-23950W001 elastic layer 3106. In examples where the elastic layer 3106 comprises one or more elastic bands, the bands can be helically wrapped around the mesh structure 3104. In some examples, the elastic layer 3106 may be dip-coated, electro-spun, etc. The outer polymeric layer 3108 can then be wrapped, situated, or applied around the elastic layer 3106, followed by another layer 3122 of ePTFE and one or more layers 3124 of heat-shrink tubing or heatshrink tape.

[0396] In some examples, the elastic layer 3106 can be applied to the mesh structure 3104 in a stretched, taut, or extended condition. For example, the elastic layer 3106 can be applied to the mesh structure 3104 stretched to a length that is twice its natural, relaxed length. This can cause the completed valve positioning structure to radially collapse under the influence of the elastic layer when removed from the mandrel, which can cause corresponding relaxation of the elastic layer. In some examples, the polymeric layer 3102 and the mesh structure 3104 can be removed from the mandrel, the elastic layer 3106 can be applied in a relaxed state or moderately stretched state, and then the assembly can be placed back on the mandrel such that the elastic layer is radially expanded and stretched to a taut condition prior to application of the outer layer 3108.

[0397] The assembly can then be heated to a sufficiently high temperature that the heatshrink layer 3124 shrinks and compresses the layers 3102-3108 together. In some examples, the assembly can be heated to a sufficiently high temperature such that the polymeric inner and outer layers 3102 and 3108 become soft and tacky and bond to each other in the open spaces of the cells of the mesh structure 3104 and the elastic layer 3106 to encapsulate the mesh structure and the elastic layer. In some examples, the inner and outer layers 3102, 3108 can be reflowed or melted such that they flow around and through the mesh structure 3104 and the elastic layer 3106. In some examples, the assembly can be heated at 150°C for 20-30 minutes.

[0398] After heating, the valve positioning structure 3100 can be removed from the mandrel 3118, and the heat-shrink tubing 3124 and the ePTFE layers 3120 and 3122 can be removed. In some examples, the ePTFE layers can behave as sacrificial layers. Upon being removed from the mandrel 3118, the valve positioning structure 3100 can at least partially radially collapse to the natural design diameter under the influence of the elastic layer 106. In some examples, the valve positioning structure 3100 can be radially collapsed (crimped) to the design diameter with the optional aid of a crimping device. In use, the valve positioningTHVMC-23950W001 structure 3100 can radially expanded under the force of a balloon, and then at least partially collapse or fully collapse to a radially collapsed state (e.g., as shown in FIG. 9A) when the balloon is deflated under the resiliency of the mesh structure 3104, the elastic layer 3106, and / or the polymer layers 3102, 3108.

[0399] In some examples, a layer of PTFE can be interposed between the ePTFE layer 3120 and the inner layer 3102, and / or between the outer layer 3108 and the ePTFE layer 3122, in order to facilitate separation of the inner and outer polymeric layers 3102, 3108 from the respective ePTFE layers 3120 and 3122. In some examples, one of the inner polymeric layer 3102 or the outer polymeric layer 3108 may be omitted.

[0400] FIGS. 36A and 36B show end views of a valve positioning structure 3501 which can have one or more features of the valve positioning structure 3100 and / or one or more features of other valve positioning structures disclosed herein. FIG. 36A shows the valve positioning structure 3501 in an exemplary pre-crimped (non-compressed) state and FIG. 36B shows the valve positioning structure 3501 in an exemplary crimped (compressed) state. The valve positioning structure 3501 can include an inner polymeric layer (inner liner) 3513, an outer polymeric layer (outer liner) 3517, and an outer covering 3561. One or more additional layers, for example, a mesh structure 3104 and / or an elastic layer 3106, can be placed between the inner liner and the outer liner. For example, a layup for forming the valve positioning structure 3501 can include the inner layer 3513, the mesh structure 3104, the elastic layer 3106, the outer layer 3517, and the outer covering 3561.

[0401] In some examples, a method of compressing (crimping) the valve positioning structure can include: covering (while in the pre-crimped state) the valve positioning structure 3501 with an external covering layer 3561 having a melting temperature TM1 which is lower than the melting temperature TM2 of the inner and outer polymeric layers; heating at least one region, which, in some examples, does not span the entire area of overlap between the cover layer 3561 and the valve positioning structure 3501, to a first temperature which is equal or higher than TM2, thereby melting both the covering layer 3561 and the outer polymeric layer 3517 of the valve positioning structure 3501, so as to create at attachment region therebetween; inserting a distal end portion of a delivery apparatus (including a balloon mounted thereon) into the lumen of the valve positioning structure 3501 and crimping the valve positioning structure around the balloon; heating the external covering layer 3561 over the valve positioning structure 3501 to a second temperature which is at leastTHVMC-23950W001 equal to or higher than the melting temperature TM1 of the external covering layer 3561 and lower than the melting temperature TM2 of the inner and outer polymeric layers 3513, 3517 for a predefined first time window. In some examples, folds 3563 are created along the external layer 3561 during crimping. The heating to the second temperature is sufficient to melt the external covering layer 3561 so as to attach the folds 3563 to each other (for example, closing the gaps 3565 therebetween) while avoiding similar melting and attachment of the inner and outer polymeric layers.

[0402] Additional materials and methods that can be utilized with the exemplary valve positioning structures and exemplary methods disclosed herein are described in International Patent Application Publication No. WO 2023 / 014551, which is incorporated by reference herein.

[0403] Any of the systems, devices, apparatuses, etc. herein can be sterilized (for example, with heat / thermal, pressure, steam, radiation, and / or chemicals, etc.) to ensure they are safe for use with patients, and any of the methods herein can include sterilization of the associated system, device, apparatus, etc. as one of the steps of the method. Examples of heat / thermal sterilization include steam sterilization and autoclaving. Examples of radiation for use in sterilization include, without limitation, gamma radiation, ultra-violet radiation, and electron beam. Examples of chemicals for use in sterilization include, without limitation, ethylene oxide, hydrogen peroxide, peracetic acid, formaldehyde, and glutaraldehyde. Sterilization with hydrogen peroxide may be accomplished using hydrogen peroxide plasma, for example. Delivery Techniques

[0404] For implanting a prosthetic valve within the native aortic valve via a transfemoral delivery approach, the prosthetic valve is mounted in a radially compressed state along the distal end portion of a delivery apparatus. The prosthetic valve and the distal end portion of the delivery apparatus are inserted into a femoral artery and are advanced into and through the descending aorta, around the aortic arch, and through the ascending aorta. The prosthetic valve is positioned within the native aortic valve and radially expanded (for example, by inflating a balloon, actuating one or more actuators of the delivery apparatus, or deploying the prosthetic valve from a sheath to allow the prosthetic valve to self-expand).Alternatively, a prosthetic valve can be implanted within the native aortic valve in a transapical procedure, whereby the prosthetic valve (on the distal end portion of the delivery apparatus) is introduced into the left ventricle through a surgical opening in the chest and theTHVMC-23950W001 apex of the heart and the prosthetic valve is positioned within the native aortic valve. Alternatively, in a transaortic procedure, a prosthetic valve (on the distal end portion of the delivery apparatus) is introduced into the aorta through a surgical incision in the ascending aorta, such as through a partial J-sternotomy or right parasternal mini-thoracotomy, and then advanced through the ascending aorta toward the native aortic valve. Alternatively, a prosthetic valve can be delivered to the native aortic valve via a subclavian artery, an axillary artery', a carotid artery, or via a transcaval delivery procedure.

[0405] For implanting a prosthetic valve within the native mitral valve via a transseptal delivery approach, the prosthetic valve is mounted in a radially compressed state along the distal end portion of a delivery apparatus. The prosthetic valve and the distal end portion of the delivery apparatus are inserted into a femoral vein and are advanced into and through the inferior vena cava, into the right atrium, across the atrial septum (through a puncture made in the atrial septum), into the left atrium, and toward the native mitral valve. Alternatively, a prosthetic valve can be implanted within the native mitral valve in a transapical procedure, whereby the prosthetic valve (on the distal end portion of the delivery apparatus) is introduced into the left ventricle through a surgical opening in the chest and the apex of the heart and the prosthetic valve is positioned within the native mitral valve.

[0406] For implanting a prosthetic valve within the native tricuspid valve, the prosthetic valve is mounted in a radially compressed state along the distal end portion of a delivery apparatus. The prosthetic valve and the distal end portion of the delivery apparatus are inserted into a femoral vein and are advanced into and through the inferior vena cava, and into the right atrium, and the prosthetic valve is positioned within the native tricuspid valve. A similar approach can be used for implanting the prosthetic valve within the native pulmonary valve or the pulmonary artery, except that the prosthetic valve is advanced through the native tricuspid valve into the right ventricle and toward the pulmonary valve / pulmonary artery.

[0407] Another delivery approach is a transatrial approach whereby a prosthetic valve (on the distal end portion of the delivery apparatus) is inserted through an incision in the chest and an incision made through an atrial wall (of the right or left atrium) for accessing any of the native heart valves. Atrial delivery can also be made intravascularly, such as from a pulmonary vein. Still another delivery approach is a transventricular approach whereby a prosthetic valve (on the distal end portion of the delivery apparatus) is inserted through anTHVMC-23950W001 incision in the chest and an incision made through the wall of the right ventricle (typically at or near the base of the heart) for implanting the prosthetic valve within the native tricuspid valve, the native pulmonary valve, or the pulmonary artery.

[0408] In all delivery approaches, the delivery apparatus can be advanced over a guidewire previously inserted into a patient’s vasculature. Moreover, the disclosed delivery approaches are not intended to be limited. Any of the prosthetic valves disclosed herein can be implanted using any of various delivery procedures and delivery devices known in the art.Additional Examples of the Disclosed Technology

[0409] In view of the above-described implementations of the disclosed subject matter, this application discloses the additional examples enumerated below. It should be noted that one feature of an example in isolation or more than one feature of the example taken in combination and, optionally, in combination with one or more features of one or more further examples are further examples also falling within the disclosure of this application.

[0410] Example 1. A delivery system for delivering a prosthetic valve through vasculature of a patient can comprise: a handle, a shaft, a balloon, and a valve positioning structure. The shaft can be coupled to the handle. The balloon can be coupled to a distal end portion of the shaft. The balloon can be configured to be inflated from a first, deflated state to a second, radially expanded, inflated state. The balloon can include a valve mounting portion for mounting the prosthetic valve in a radially compressed state. The valve positioning structure can extend at least partially over an exterior surface of the balloon and can have a first end portion and a second end portion. The valve positioning structure can be configured to radially expand from a radially collapsed state to a radially expanded state when the balloon is inflated and then resiliently radially collapse from the radially expanded state to the radially collapsed state when the balloon is deflated.

[0411] Example 2. The delivery system of any example herein, particularly Example 1, wherein the valve positioning structure can comprise a frame constructed of a shape-memory material, wherein the frame can be shape set in the radially collapsed configuration.

[0412] Example 3. The delivery system of any example herein, particularly Example 2, wherein the shape-memory material can be Nitinol.THVMC-23950W001

[0413] Example 4. The delivery system of any example herein, particularly any one of Examples 1-3, wherein the valve positioning structure can extend around the exterior surface of the balloon at the first end portion.

[0414] Example 5. The delivery system of any example herein, particularly Example 4, wherein the first end portion can be a distal end portion of the balloon.

[0415] Example 6. The delivery system of any example herein, particularly Example 4, wherein the first end portion can be a proximal end portion of the balloon.

[0416] Example 7. The delivery system of any example herein, particularly Example 4, wherein the valve positioning structure can extend around the exterior surface of the balloon at both the first end portion and the second end portion of the balloon.

[0417] Example 8. The delivery system of any example herein, particularly any one of Examples 1-7, wherein the valve positioning structure can comprise a proximal valve positioning portion, a distal valve positioning portion, and an intermediate valve positioning portion disposed between the proximal and distal valve positioning portions.

[0418] Example 9. The delivery system of any example herein, particularly Example 8, wherein the proximal valve positioning portion of the valve positioning structure can be coupled to the shaft.

[0419] Example 10. The delivery system of any example herein, particularly Example 8, wherein the proximal valve positioning portion can be coupled to an inner surface of the shaft.

[0420] Example 11. The delivery system of any example herein, particularly Example 8, wherein the proximal valve positioning portion can be coupled to an outer surface of the shaft.

[0421] Example 12. The delivery system of any example herein, particularly Example 8, wherein the delivery system can further comprise a nose cone distally disposed relative to the balloon, and wherein distal valve positioning portion of the valve positioning structure can be coupled to the nose cone.

[0422] Example 13. The delivery system of any example herein, particularly any one of Examples 8-12, wherein the intermediate valve positioning portion can be configured to receive the prosthetic valve.THVMC-23950W001

[0423] Example 14. The delivery system of any example herein, particularly any one of Examples 8-13, wherein the distal valve positioning portion can have an outer diameter that is greater than an outer diameter of the intermediate valve positioning portion.

[0424] Example 15. The delivery system of any example herein, particularly any one of Examples 8-14, wherein the proximal valve positioning portion can have an outer diameter that is greater than an outer diameter of the intermediate valve positioning portion.

[0425] Example 16. The delivery system of any example herein, particularly any one of Examples 8-15, wherein the distal valve positioning portion can taper in diameter in a direction from the intermediate valve positioning portion to a distal end of the valve positioning structure.

[0426] Example 17. The delivery system of any example herein, particularly any one of Examples 8-16, wherein the proximal valve positioning portion can taper in diameter in a direction from the intermediate valve positioning portion to a proximal end of the valve positioning structure.

[0427] Example 18. The delivery system of any example herein, particularly any one of Examples 8-17, wherein the distal valve positioning portion can have a frustoconical shape.

[0428] Example 19. The delivery system of any example herein, particularly any one of Examples 8-18, wherein the proximal valve positioning portion can have a frustoconical shape.

[0429] Example 20. The delivery system of any example herein, particularly any one of Examples 8-19, wherein the distal valve positioning portion can comprise a plurality of struts.

[0430] Example 21. The delivery system of any example herein, particularly Example 20, wherein the plurality of struts can include a first plurality of struts arranged in a first row that extends in a circumferential direction of the delivery system and a second plurality of struts arranged in a second row that extends in the circumferential direction.

[0431] Example 22. The delivery system of any example herein, particularly Example 21, wherein each one of the first plurality of struts can be a linear strut oriented at an angle relative to an axial direction of the delivery system.

[0432] Example 23. The delivery system of any example herein, particularly Example 22, wherein each one of the first plurality of struts can be a linear strut oriented in an axial direction of the delivery system.THVMC-23950W001

[0433] Example 24. The delivery system of any example herein, particularly any one of Examples 21-23, wherein each one of the second plurality of struts can be a serpentine strut.

[0434] Example 25. The delivery system of any example herein, particularly Example 24, wherein the serpentine strut can form a plurality of semicircular turns.

[0435] Example 26. The delivery system of any example herein, particularly Example 24, wherein the serpentine strut can form a plurality of curves that each extend less than 180 degrees.

[0436] Example 27. The delivery system of any example herein, particularly any one of Examples 21-26, wherein each one of the second plurality of struts can be a zigzag strut.

[0437] Example 28. The delivery system of any example herein, particularly any one of Examples 8-27, wherein the proximal valve positioning portion can comprise a plurality of struts.

[0438] Example 29. The delivery system of any example herein, particularly Example 28, wherein the plurality of struts can include a first plurality of struts arranged in a first row that can extend in a circumferential direction of the delivery system and a second plurality of struts that can be arranged in a second row that can extend in the circumferential direction.

[0439] Example 30. The delivery system of any example herein, particularly Example 29, wherein each one of the first plurality of struts can be a linear strut oriented at an angle relative to an axial direction of the delivery system.

[0440] Example 31. The delivery system of any example herein, particularly any one of Examples 29-30, wherein each one of the second plurality of struts can be a serpentine strut.

[0441] Example 32. The delivery system of any example herein, particularly Example 31, wherein the serpentine strut can form a plurality of semicircular turns.

[0442] Example 33. The delivery system of any example herein, particularly Example 31 , wherein the serpentine strut can form a plurality of curves that each extend less than 180 degrees.

[0443] Example 34. The delivery system of any example herein, particularly any one of Examples 29-30, wherein each one of the second plurality of struts can be a zigzag strut.

[0444] Example 35. The delivery system of any example herein, particularly any one of Examples 8-34, wherein the intermediate valve positioning portion can comprise a plurality of axial connecting struts that connect the distal valve positioning portion and the proximal valve positioning portion.THVMC-23950W001

[0445] Example 36. The delivery system of any example herein, particularly any one of Examples 1-35, wherein the balloon can have an axial length in a range from 45 mm to 51 mm.

[0446] Example 37. The delivery system of any example herein, particularly Example 36, wherein the balloon can have an axial length in a range from 46 mm to 50 mm.

[0447] Example 38. The delivery system of any example herein, particularly any one of Examples 1-35, wherein the balloon can have an axial length in a range from 31 mm to 45 mm.

[0448] Example 39. The delivery system of any example herein, particularly Example 38, wherein the balloon can have an axial length in a range from 31 mm to 36 mm.

[0449] Example 40. The delivery system of any example herein, particularly any one of Examples 1-35, wherein the balloon can have an axial length in a range from 25 mm to 31 mm.

[0450] Example 41. The delivery system of any example herein, particularly Example 40, wherein the balloon can have an axial length in a range from 26 mm to 30 mm.

[0451] Example 42. The delivery system of any example herein, particularly any one of Examples 1-19, wherein the frame can comprise a braided mesh structure.

[0452] Example 43. The delivery system of any example herein, particularly any one of Examples 1-42, wherein the valve positioning structure can prevent the prosthetic valve from contacting the balloon.

[0453] Example 44. The delivery system of any example herein, particularly any one of Examples 1-43, wherein the valve positioning structure can be configured such that it does not overlap an outer surface of the prosthetic valve.

[0454] Example 45. The delivery system of any example herein, particularly any one of Examples 1-44, wherein the valve positioning structure can comprise a polymeric coating attached to the frame.

[0455] Example 46. The delivery system of any example herein, particularly Example 45, wherein the polymeric coating can be disposed on an inner surface of the frame.

[0456] Example 47. The delivery system of any example herein, particularly Example 45, wherein the polymeric coating can be disposed on an outer surface of the frame.

[0457] Example 48. The delivery system of any example herein, particularly Example 45, wherein the polymeric coating can encapsulate the frame.THVMC-23950W001

[0458] Example 49. The delivery system of any example herein, particularly any one of Examples 1-48, wherein the valve positioning structure can be not attached to the exterior surface of the balloon.

[0459] Example 50. The delivery system of any example herein, particularly any one of Examples 1-49, which can further comprise the prosthetic valve, wherein the prosthetic valve can be mounted over the valve mounting portion of the balloon.

[0460] Example 51. A delivery apparatus for delivering a prosthetic valve through vasculature of a patient can comprise: a handle, a balloon catheter, and a first valve positioning structure. The balloon catheter can comprise a shaft coupled to the handle and a balloon connected to a distal end portion of the shaft. The balloon can be configured to be inflated from an uninflated state to an inflated state. The first valve positioning structure can extend over an exterior surface of the balloon. The first valve positioning structure can comprise a first frame constructed of a shape-memory material. The first frame can be shape set in a radially compressed configuration.

[0461] Example 52. The delivery apparatus of any example herein, particularly Example51 , can further comprise a second valve positioning structure extending over the exterior surface of the balloon, wherein: the second valve positioning structure can comprise a second frame constructed of the shape-memory material, the second frame can be shape set in a radially compressed configuration, and the first valve positioning structure and the second valve positioning structure can be configured to expand to a radially expanded state when the balloon is in the inflated state.

[0462] Example 53. The delivery apparatus of any example herein, particularly Example52, wherein each one of the first frame and the second frame can comprise a plurality of interconnected struts defining a plurality of cells.

[0463] Example 54. The delivery apparatus of any example herein, particularly any one of Examples 52-53, wherein the first valve positioning structure and the second valve positioning structure can be spaced apart in an axial direction of the delivery apparatus and can define a valve mounting portion of the delivery apparatus configured to receive the prosthetic valve.

[0464] Example 55. The delivery apparatus of any example herein, particularly Example 54, wherein the first valve positioning structure can be distally disposed relative to the second valve positioning structure.THVMC-23950W001

[0465] Example 56. The delivery apparatus of any example herein, particularly any one of Examples 54-55, which can further comprise the prosthetic valve, wherein the prosthetic valve can be mounted over a valve mounting portion of the balloon.

[0466] Example 57. The delivery apparatus of any example herein, particularly Example 56, wherein neither the first valve positioning structure nor the second valve positioning structure can extend over an outer surface of the prosthetic valve when the prosthetic valve is mounted over the valve mounting portion.

[0467] Example 58. The delivery apparatus of any example herein, particularly any one of Examples 56-57, wherein the valve mounting portion can be disposed between the first and second valve positioning structures.

[0468] Example 59. The delivery apparatus of any example herein, particularly any one of Examples 56-58, wherein an outer diameter of the first valve positioning structure in the radially compressed configuration can be greater than an outer diameter of the prosthetic valve in a radially compressed configuration.

[0469] Example 60. The delivery apparatus of any example herein, particularly Example 59, wherein an outer diameter of the second valve positioning structure in the radially compressed configuration can be greater than an outer diameter of the prosthetic valve in the radially compressed configuration.

[0470] Example 61. The delivery apparatus of any example herein, particularly any one of Examples 51-60, wherein the first valve positioning structure can comprise a distal end and a proximal end, wherein an outer diameter of the first valve positioning structure at the distal end can be smaller than an outer diameter of the first valve positioning structure at a location between the distal end and the proximal end when the first valve positioning structure is in the radially compressed configuration.

[0471] Example 62. The delivery apparatus of any example herein, particularly any one of Examples 52-61, wherein at least one of the first valve positioning structure and the second valve positioning structure can comprise Nitinol.

[0472] Example 63. The delivery apparatus of any example herein, particularly any one of Examples 51-62, which can further comprise at least one tether connected to the first valve positioning structure.

[0473] Example 64. A delivery system for delivering a prosthetic valve through vasculature of a patient can comprise: a radially expandable prosthetic valve and a delivery apparatus.THVMC-23950W001The delivery apparatus can comprise: a handle, a shaft, an expandable distal valve positioning structure, and a an expandable proximal valve positioning structure. The shaft can be coupled to the handle and a balloon coupled to a distal end portion of the shaft. The balloon can be configured to be inflated from a first, deflated state to a second, radially expanded, inflated state. The prosthetic valve can be mounted on the balloon in a radially compressed state. The expandable distal valve positioning structure can be disposed on an exterior surface of a distal end portion of the balloon. The expandable proximal valve positioning structure can be disposed on an exterior surface of a proximal end portion of the balloon. The distal and proximal valve positioning structures can be configured to radially expand from a radially collapsed state to a radially expanded state when the balloon is inflated and then radially collapse from the radially expanded state to the radially collapsed state when the balloon is deflated.

[0474] Example 65. The delivery system of any example herein, particularly Example 64, wherein the delivery apparatus can further comprise at least one tether connected to the distal valve positioning structure.

[0475] Example 66. The delivery system of any example herein, particularly Example 65, wherein the at least one tether can be configured to cause the distal valve positioning structure to further radially collapse when the distal valve positioning structure is in the radially collapsed state and tension is increased in the tether.

[0476] Example 67. The delivery apparatus of any example herein, particularly any one of Examples 65-66, wherein an intermediate portion of the at least one tether can be looped around a portion of the distal valve positioning structure.

[0477] Example 68. The delivery apparatus of any example herein, particularly any one of Examples 65-66, wherein the at least one tether can include a distal end portion that terminates in a loop secured to portion of the distal valve positioning structure.

[0478] Example 69. The delivery apparatus of any example herein, particularly any one of Examples 65-68, wherein the at least one tether can extend through a lumen of the shaft and along an outer surface of the balloon.

[0479] Example 70. A delivery system for delivering a prosthetic valve through vasculature of a patient can comprise: a radially expandable prosthetic valve and a delivery apparatus. The delivery apparatus can comprise: a handle, a shaft, and an expandable valve positioning structure. The shaft can be coupled to the handle and a balloon coupled to a distal endTHVMC-23950W001 portion of the shaft. The balloon can be configured to be inflated from a first, deflated state to a second, radially expanded, inflated state. The prosthetic valve can be mounted on the balloon in a radially compressed state. The expandable valve positioning structure can be disposed on an exterior surface of a portion of the balloon. The valve positioning structure can be configured to radially expand from a radially collapsed state to a radially expanded state when the balloon is inflated and then resiliently radially collapse from the radially expanded state to the radially collapsed state when the balloon is deflated.

[0480] Example 71. The delivery system of any example herein, particularly Example 70, wherein the valve positioning structure can be constructed of a shape-memory material.

[0481] Example 72. The delivery system of any example herein, particularly Example 71, wherein the valve positioning structure can be shape set into the radially collapsed state.

[0482] Example 73. The delivery system of any example herein, particularly any one of Examples 70-72, wherein the expandable valve positioning structure can comprise a frame that includes a distal valve positioning portion, a proximal valve positioning portion, and an intermediate valve positioning portion disposed between the distal valve positioning portion and the proximal valve positioning portion.

[0483] Example 74. The delivery system of any example herein, particularly Example 73, wherein each of the distal valve positioning portion and the proximal valve positioning portion can have an outer diameter, and wherein each of the outer diameters of the distal valve positioning portion and the proximal valve positioning portion are greater than an outer diameter of the intermediate valve positioning portion when the valve positioning structure is in the radially collapsed state.

[0484] Example 75. The delivery system of any example herein, particularly any one of Examples 73-74, wherein each of the distal valve positioning portion and the proximal valve positioning portion can have an outer diameter, and wherein each of the outer diameters of the distal valve positioning portion and the proximal valve positioning portion can be greater than an outer diameter of the intermediate valve positioning portion when the valve positioning structure is in a partially radially expanded state between the radially collapsed state and the radially expanded state.

[0485] Example 76. The delivery system of any example herein, particularly any one of Examples 73-75, wherein each of the distal valve positioning portion, the proximal valve positioning portion, and the intermediate valve positioning portion can have an outerTHVMC-23950W001 diameter, and wherein the outer diameters can be equal when the valve positioning structure is in the radially expanded state.

[0486] Example 77. The delivery system of any example herein, particularly any one of Examples 73-76, wherein the distal valve positioning portion can comprise a plurality of struts.

[0487] Example 78. The delivery system of any example herein, particularly Example 77, wherein the plurality of struts can include a first plurality of struts arranged in a first row that can extend in a circumferential direction of the delivery system and a second plurality of struts arranged in a second row that can extend in the circumferential direction.

[0488] Example 79. The delivery system of any example herein, particularly Example 78, wherein each one of the first plurality of struts can be a linear strut oriented at an angle relative to an axial direction of the delivery system.

[0489] Example 80. The delivery system of any example herein, particularly Example 78, wherein each one of the first plurality of struts can be a linear strut oriented in an axial direction of the delivery system.

[0490] Example 81. The delivery system of any example herein, particularly any one of Examples 78-80, wherein each one of the second plurality of struts can be a serpentine strut.

[0491] Example 82. The delivery system of any example herein, particularly Example 81, wherein the serpentine strut can form a plurality of semicircular turns.

[0492] Example 83. The delivery system of any example herein, particularly Example 81, wherein the serpentine strut can form a plurality of curves that each extend less than 180 degrees.

[0493] Example 84. The delivery system of any example herein, particularly any one of Examples 78-80, wherein each one of the second plurality of struts can be a zigzag strut.

[0494] Example 85. The delivery system of any example herein, particularly any one of Examples 78-84, wherein the proximal valve positioning portion can comprise a plurality of struts.

[0495] Example 86. The delivery system of any example herein, particularly Example 85, wherein the plurality of struts can include a first plurality of struts arranged in a first row that can extend in a circumferential direction of the delivery apparatus and a second plurality of struts arranged in a second row that can extend in the circumferential direction.THVMC-23950W001

[0496] Example 87. The delivery system of any example herein, particularly Example 86, wherein each one of the first plurality of struts can be a linear strut oriented at an angle relative to an axial direction of the delivery apparatus.

[0497] Example 88. The delivery system of any example herein, particularly any one of Examples 86-87, wherein each one of the second plurality of struts can be a serpentine strut.

[0498] Example 89. The delivery system of any example herein, particularly Example 88, wherein the serpentine strut can form a plurality of semicircular turns.

[0499] Example 90. The delivery system of any example herein, particularly Example 88, wherein the serpentine strut can form a plurality of curves that each extend less than 180 degrees.

[0500] Example 91. The delivery system of any example herein, particularly any one of Examples 86-87, wherein each one of the second plurality of struts can be a zigzag strut.

[0501] Example 92. The delivery system of any example herein, particularly any one of Examples 73-91, wherein the intermediate valve positioning portion can comprise a plurality of axial connecting struts that connect the distal valve positioning portion and the proximal valve positioning portion.

[0502] Example 93. The delivery system of any example herein, particularly any one of Examples 70-92, wherein the balloon can have an axial length in a range from 45 mm to 51 mm.

[0503] Example 94. The delivery system of any example herein, particularly Example 93, wherein the balloon can have an axial length in a range from 46 mm to 50 mm.

[0504] Example 95. The delivery system of any example herein, particularly any one of Examples 70-92, wherein the balloon can have an axial length in a range from 31 mm to 45 mm.

[0505] Example 96. The delivery system of any example herein, particularly Example 95, wherein the balloon can have an axial length in a range from 31 mm to 36 mm.

[0506] Example 97. The delivery system of any example herein, particularly any one of Examples 70-92, wherein the balloon can have an axial length in a range from 25 mm to 31 mm.

[0507] Example 98. The delivery system of any example herein, particularly Example 97, wherein the balloon can have an axial length in a range from 26 mm to 30 mm.THVMC-23950W001

[0508] Example 99. A delivery apparatus for delivering a prosthetic valve through vasculature of a patient can comprise: a handle, a shaft, a balloon, and a valve positioning system. The shaft can be coupled to the handle. The balloon can be coupled to a distal end portion of the shaft. The balloon can be configured to be inflated from a first, deflated state to a second, radially expanded, inflated state. The balloon can have a proximal end portion, a distal end portion, and a valve mounting portion disposed between the proximal and distal end portions for mounting the prosthetic valve in a radially compressed state. The valve positioning structure can comprise a frame, wherein the valve positioning structure can be positioned radially outward of the balloon, the valve positioning structure can extend over the proximal end portion of the balloon, the valve mounting portion of the balloon, and the distal end portion of the balloon, and the valve positioning structure can be configured to radially expand from a radially collapsed state to a radially expanded state when the balloon is inflated and then radially collapse from the radially expanded state to the radially collapsed state when the balloon is deflated.

[0509] Example 100. The delivery apparatus of any example herein, particularly Example 99, wherein the valve positioning structure can extend an entire length of the balloon.

[0510] Example 101. The delivery apparatus of any example herein, particularly any one of Examples 99-100, wherein the frame can comprise a shape-memory material and can be shape set in the radially collapsed state so that the frame collapses under its own resiliency when the balloon is deflated.

[0511] Example 102. The delivery apparatus of any example herein, particularly any one of Examples 99-101, wherein the frame can comprise a plurality of interconnected struts.

[0512] Example 103. The delivery apparatus of any example herein, particularly any one of Examples 99-101, wherein the frame can comprise a braided mesh structure.

[0513] Example 104. The delivery apparatus of any example herein, particularly any one of Examples 99-103, wherein the frame of the valve positioning structure can comprise a distal valve positioning portion, a proximal valve positioning portion, and an intermediate valve positioning portion disposed between the distal valve positioning portion and the proximal valve positioning portion.

[0514] Example 105. The delivery apparatus of any example herein, particularly Example 104, wherein the distal valve positioning portion can taper towards a distal end portion of the valve positioning structure.THVMC-23950W001

[0515] Example 106. The delivery apparatus of any example herein, particularly any one of Examples 104-105, wherein the proximal valve positioning portion can taper towards a proximal end portion of the valve positioning structure.

[0516] Example 107. The delivery apparatus of any example herein, particularly any one of Examples 104-106, wherein: a distal end portion of the distal valve positioning portion can define a first diameter and a proximal end portion of the distal valve positioning portion defines a second diameter, and the second diameter can be greater than the first diameter.

[0517] Example 108. The delivery apparatus of any example herein, particularly Example107, wherein: the intermediate valve positioning portion can define a third diameter, and the second diameter can be greater than the third diameter.

[0518] Example 109. The delivery apparatus of any example herein, particularly Example108, wherein: a distal end portion of the proximal valve positioning portion can define a fourth diameter and a proximal end portion of the proximal valve positioning portion can define a fifth diameter, and the fifth diameter can be greater than the fourth diameter.

[0519] Example 110. The delivery apparatus of any example herein, particularly Example109, wherein the fourth diameter can be greater than the third diameter.

[0520] Example 111. The delivery apparatus of any example herein, particularly Example110, wherein the first, third, and fifth diameters can be substantially equal.

[0521] Example 112. The delivery apparatus of any example herein, particularly Example 104, wherein a region between the distal valve positioning portion and the intermediate valve positioning portion can be flared.

[0522] Example 113. The delivery apparatus of any example herein, particularly Example 104, wherein a region between the proximal valve positioning portion and the intermediate valve positioning portion can be flared.

[0523] Example 1 14. The delivery apparatus of any example herein, particularly any one of Examples 104-113, wherein the intermediate valve positioning portion can be cylindrical.THVMC-23950W001

[0524] Example 115. A delivery apparatus for a prosthetic medical device can comprise a handle, a shaft, a balloon, and a valve positioning system. The shaft can be coupled to the handle. The balloon can be coupled to a distal end portion of the shaft. The valve positioning structure can extend at least partially over an outer surface of the balloon, wherein the valve positioning structure can comprise a frame constructed of a shape-memory material.

[0525] Example 116. The delivery apparatus of any example herein, particularly Example 11 , wherein the valve positioning structure can be not attached to the outer surface of the balloon.

[0526] Example 117. The delivery apparatus of any example herein, particularly any one of Examples 115-116, wherein a proximal end portion of the valve positioning structure can be fixed to the shaft.

[0527] Example 118. The delivery apparatus of any example herein, particularly Example 117, wherein a proximal end portion of the valve positioning structure can be fixed to an inner surface of the shaft.

[0528] Example 119. The delivery apparatus of any example herein, particularly Example 117, wherein a proximal end portion of the valve positioning structure can be fixed to an outer surface of the shaft.

[0529] Example 120. The delivery apparatus of any example herein, particularly any one of Examples 115-119, wherein the delivery apparatus can further comprise a nose cone distally disposed relative to the balloon and the valve positioning structure.

[0530] Example 121. The delivery apparatus of any example herein, particularly Example 120, wherein a distal end portion of the valve positioning structure can be fixed to the nose cone.

[0531] Example 122. The delivery apparatus of any example herein, particularly any one of Examples 115-121, wherein the valve positioning structure can be expandable from a radially collapsed state to a radially expanded state when the balloon is inflated to an inflated state.

[0532] Example 123. The delivery apparatus of any example herein, particularly Example 122, wherein the valve positioning structure can be collapsible from the radially expanded state to the radially collapsed state when the balloon is deflated to a deflated state.THVMC-23950W001

[0533] Example 124. The delivery apparatus of any example herein, particularly Example 123, wherein the valve positioning structure can collapse under its own resiliency from the radially expanded state to the radially collapsed state.

[0534] Example 125. The delivery apparatus of any example herein, particularly any one of Examples 122-124, wherein the prosthetic medical device can be configured to be mounted around the valve positioning structure.

[0535] Example 126. The delivery apparatus of any example herein, particularly Example 125, wherein the prosthetic medical device may not contact an outer surface of the balloon when the prosthetic medical device is mounted around the valve positioning structure when the valve positioning structure is in the radially collapsed state.

[0536] Example 127. A delivery apparatus for a prosthetic medical device can comprise: a handle, a shaft, a balloon, and a valve positioning structure. The shaft can be coupled to the handle. The balloon can be coupled to a distal end portion of the shaft and can comprise an outer surface. The valve positioning structure can extend at least partially over the outer surface of the balloon and can comprise a frame that includes a plurality of struts. The frame can define an axial direction and a circumferential direction.

[0537] Example 128. The delivery apparatus of any example herein, particularly Example127, wherein the plurality of struts can comprise a first plurality of struts and a second plurality of struts.

[0538] Example 129. The delivery apparatus of any example herein, particularly Example128, wherein the first plurality of struts can each have a linear shape.

[0539] Example 130. The delivery apparatus of any example herein, particularly any one of Examples 128-129, wherein the first plurality of struts can be each oriented at an angle relative to the axial direction of the frame.

[0540] Example 131. The delivery apparatus of any example herein, particularly any one of Examples 128-130, wherein the first plurality of struts can be arranged into at least one row that extends in the circumferential direction of the frame.

[0541] Example 132. The delivery apparatus of any example herein, particularly any one of Examples 128-131, wherein adjacent ends of the first plurality of struts can point in the axial direction of the frame.

[0542] Example 133. The delivery apparatus of any example herein, particularly any one of Examples 128-132, wherein the plurality of second struts can each have a sawtooth shape.THVMC-23950W001

[0543] Example 134. The delivery apparatus of any example herein, particularly any one of Examples 128-133, wherein the plurality of second struts can be arranged into at least one row that extends in the circumferential direction of the frame.

[0544] Example 135. The delivery apparatus of any example herein, particularly any one of Examples 128-134, wherein adjacent ends of the plurality of second struts can point in the circumferential direction of the frame.

[0545] Example 136. The delivery apparatus of any example herein, particularly any one of Examples 128-135, wherein the plurality of struts can further comprise a third plurality of struts.

[0546] Example 137. The delivery apparatus of any example herein, particularly Example 136, wherein: each one of the third plurality of struts can comprise a distal end and a proximal end, each one of the third plurality of struts can connect at its distal end to a junction of two of the first plurality of struts, and each one of the third plurality of struts can connect at its proximal end to a junction of another two of the first plurality of struts.

[0547] Example 138. The delivery apparatus of any example herein, particularly any one of Examples 127-137, wherein the frame of the valve positioning structure can be a unitary structure.

[0548] Example 139. The delivery apparatus of any example herein, particularly any one of Examples 127-138, wherein the frame of the valve positioning structure can lack fasteners.

[0549] Example 140. The delivery apparatus of any example herein, particularly any one of Examples 127-140, wherein the frame of the valve positioning structure can be constructed of a shape-memory material.

[0550] Example 141. The delivery apparatus of any example herein, particularly Example 140, wherein the frame is constructed of Nitinol.

[0551] Example 142. The delivery apparatus of any example herein, particularly any one of Examples 140-141, wherein the frame of the valve positioning structure can be configured to collapse from a radially expanded state to a radially collapsed state under its own resiliency.

[0552] Example 143. The delivery apparatus of any example herein, particularly Example 143, wherein the frame can be shape set in the radially collapsed state.

[0553] Example 144. The delivery apparatus of any example herein, particularly any one of Examples 127-143, wherein the frame of the valve positioning structure can define a distalTHVMC-23950W001 valve positioning portion, a proximal valve positioning portion, and an intermediate valve positioning portion disposed between the distal and proximal valve positioning portions.

[0554] Example 145. The delivery apparatus of any example herein, particularly Example 144, wherein the distal valve positioning portion can flare from the intermediate valve positioning portion.

[0555] Example 146. The delivery apparatus of any example herein, particularly any one of Examples 144-145, wherein the distal valve positioning portion can taper towards a distal end of the frame.

[0556] Example 147. The delivery apparatus of any example herein, particularly any one of Examples 144-146, wherein the proximal valve positioning portion can flare from the intermediate valve positioning portion.

[0557] Example 148. The delivery apparatus of any example herein, particularly any one of Examples 144-147, wherein the proximal valve positioning portion can taper towards a proximal end of the frame.

[0558] Example 149. A delivery system can comprise: a balloon, an expandable distal valve positioning structure, an expandable proximal valve positioning structure, and a prosthetic heart valve. The balloon can comprise: an outer surface extending from a distal end to a proximal end of the balloon and a valve mounting portion disposed on the outer surface between the distal and proximal ends. The expandable distal valve positioning structure can extend over a distal portion of the outer surface of the balloon. The expandable proximal valve positioning structure can extend over a proximal portion of the outer surface of the balloon. The prosthetic heart valve can be crimped around the valve mounting portion of the balloon, wherein neither the distal valve positioning structure nor the proximal valve positioning structure can overlap an outer surface of the prosthetic heart valve.

[0559] Example 150. The delivery system of any example herein, particularly Example 149, wherein each of the distal valve positioning structure and the proximal valve positioning structure can comprise a frame that includes a plurality of struts.

[0560] Example 151. The delivery system of any example herein, wherein the delivery system is sterilized.

[0561] Example 152. The delivery system of any example herein, wherein the prosthetic heart valve is sterilized.THVMC-23950W001

[0562] Example 153. A method comprising: placing a support structure of a valve positioning structure in an at least partially radially expanded state; forming a webbing portion of polymeric coating spanning across at least a portion of a plurality of cells of the support structure while the support structure is in the at least partially radially expanded state to form a closed cell polymeric coating on the support structure; mounting the valve positioning structure over a balloon of a balloon catheter; and connecting the valve positioning structure to the balloon catheter such that the valve positioning structure can radially expand and collapse upon inflation and deflation of the balloon, respectively.

[0563] Example 154. The method of any example herein, particularly Example 153, wherein the at least partially radially expanded state is a partially radially expanded state.

[0564] Example 155. The method of any example herein, particularly Example 153, wherein the at least partially radially expanded state is a fully expanded state.

[0565] Example 156. The method of any example herein, particularly any one of Examples 153-155, wherein the support structure comprises a frame comprising a plurality of interconnected struts defining the plurality of cells.

[0566] Example 157. The method of any example herein, particularly Example 156, wherein the frame is formed from laser-cut Nitinol.

[0567] Example 158. The method of any example herein, particularly any one of Examples 153-155, wherein the support structure comprises a braided mesh structure comprising a plurality of braided wires defining the plurality of cells.

[0568] Example 159. The method of any example herein, particularly Example 158, wherein the braided mesh structure is formed from Nitinol wires.

[0569] Example 160. The method of any example herein, particularly either of Examples 158 or 159, wherein the valve positioning structure further comprises an elastic layer extending over at least a portion of an exterior surface of the braided wires.

[0570] Example 161. The method of any example herein, particularly any one of Examples 153-159, wherein the support structure is shape-set in a radially collapsed state.

[0571] Example 162. The method of any example herein, particularly either of Examples 160 or 161, wherein the placing the support structure of the valve positioning structure in the at least partially radially expanded state comprises mounting the support structure onto a retaining device so that the retaining device extends axially through a central lumen of the support structure.THVMC-23950W001

[0572] Example 163. The method of any example herein, particularly Example 162, wherein the retaining device is a mandrel having an exterior diameter that corresponds to an interior diameter of the support structure in the at least partially radially expanded state.

[0573] Example 164. The method of any example herein, particularly Example 162, wherein the retaining device is a balloon, and the method further comprises inflating the balloon to have an exterior diameter that corresponds to an interior diameter of the support structure in the at least partially radially expanded state.

[0574] Example 165. The method of any example herein, particularly any one of Examples 162-164, wherein the forming the webbing portion of polymeric coating comprises positioning or forming a first polymeric layer on an exterior surface of the retaining device prior to mounting the support structure onto the retaining device, the first polymeric layer extending over an interior surface of the support structure when the support structure is mounted on the retaining device.

[0575] Example 166. The method of any example herein, particularly Example 165, wherein the positioning or forming the first polymeric layer on the exterior surface of the retaining device comprises one or more of spray coating the exterior surface of the retaining device, dip coating the exterior surface of the retaining device, or wrapping a polymeric material sheet over the exterior surface of the retaining device.

[0576] Example 167. The method of any example herein, particularly either of Examples 165 or 166, further comprising positioning or forming a second polymeric layer over an exterior surface of the support structure while the support structure is mounted on the retaining device.

[0577] Example 168. The method of any example herein, particularly Example 167, wherein the positioning or forming the second polymeric layer comprises one or more of spray coating the exterior surface of the support structure, dip coating the exterior surface of the support structure, or wrapping a polymeric material sheet over the exterior surface of the support structure.

[0578] Example 169. The method of any example herein, particularly any one of Examples 162-164, further comprising forming a first layer of polymeric coating on an interior surface of the support structure by spray coating the interior surface with a polymeric material, wherein the forming the webbing portion of polymeric coating comprises forming a second layer of polymeric material over an exterior surface of the support structure by one or more ofTHVMC-23950W001 dip coating the support structure while mounted on the retaining device or wrapping a polymeric material sheet over the exterior surface of the support structure while mounted on the retaining device.

[0579] Example 170. The method of any example herein, particularly any one of Examples 167-169, further comprising heating the support structure mounted on the retaining device at a temperature that is above a melting temperature of the polymeric material to bond the first polymeric layer and the second polymeric layer.

[0580] Example 171. The method of any example herein, particularly Example 170, wherein the bonding of the first polymeric layer and the second polymeric layer results in encapsulation of the support structure.

[0581] Example 172. The method of any example herein, particularly Example 170, further comprising masking a first portion of the support structure so that a second portion of the support structure is unmasked, wherein the bonding of the first polymeric layer and the second polymeric layer results in encapsulation of the second portion of the support structure.

[0582] Example 173. The method of any example herein, particularly any one of Examples 153-159, wherein the support structure is shape-set in the at least partially radially expanded shape, and the forming the webbing portion of polymeric coating comprises dip coating the support structure, wherein the dip coating results encapsulation of at least a portion of the support structure.

[0583] Example 174. The method of any example herein, particularly any one of Examples 153-156, wherein the support structure if formed from a plastically expandable metal, and the forming the webbing portion of polymeric coating comprises dip coating the support structure, wherein the dip coating results encapsulation of at least a portion of the support structure.

[0584] Example 175. The method of any example herein, particularly any one of Examples 153-174, wherein the closed-cell polymeric coating is formed from one or more of polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (ePTFE), ethylene tetrafluoroethylene (ETFE), nylon, polyethylene, polyether block amide, bi-oriented polypropylene, cast polypropylene, thermoplastic, polyurethane, ultra-high-molecular-weight polyethylene (UHMWPE), high-molecular-weight polyethylene (HMWPE), or polyether ether ketone (PEEK).THVMC-23950W001

[0585] Example 176. A method of fabricating a valve positioning structure having an opencell polymeric coating, the method comprising: forming a support structure of the valve positioning structure such that it is shape-set in a radially collapsed state, the support structure comprising a plurality of cells; and forming a polymeric coating over interior and exterior surfaces of the support structure while the support structure is in the radially collapsed state, the forming the polymeric coating resulting in a portion of the support structure being encapsulated in the polymeric coating with the cells of the support structure open.

[0586] Example 177. The method of any example herein, particularly Example 176, wherein the support structure comprises a frame comprising a plurality of interconnected struts defining the plurality of cells.

[0587] Example 178. The method of any example herein, particularly Example 177, wherein the frame is formed from laser-cut Nitinol.

[0588] Example 179. The method of any example herein, particularly Example 176, wherein the support structure comprises a braided mesh structure comprising a plurality of braided wires defining the plurality of cells.

[0589] Example 180. The method of any example herein, particularly Example 179, wherein the braided mesh structure is formed from Nitinol wires.

[0590] Example 181. The method of any example herein, particularly any one of Examples 176-180, wherein the forming the polymeric coating over the interior and exterior surfaces of the support structure comprises spray coating the interior and exterior surfaces of the support structure such that the plurality of cells are open.

[0591] Example 182. The method of any example herein, particularly any one of Examples 176-180, wherein the forming the polymeric coating over the interior and exterior surfaces of the support structure comprises dip coating the support structure while in the radially collapsed state, and removing a webbing portion from each of the plurality of cells of the support structure after the dip coating such that the cells are open.

[0592] Example 183. The method of any example herein, particularly any one of Examples 176-180, wherein the forming the polymeric coating over the interior and exterior surfaces of the support structure comprises at least one of spray coating or dip coating the support structure while it is engaged with a blocking structure, the blocking structure including a plurality raised portions that extend into the cells of the support structure.THVMC-23950W001

[0593] Example 184. The method of any example herein, particularly any one of Examples 176-183, further comprising masking a first portion of the support structure such that a second portion of the support structure is unmasked, wherein the forming the polymeric coating results in forming the polymeric coating over the second portion of the support structure.

[0594] Example 185. The method of any example herein, particularly any one of Examples 176-184, wherein the open-cell polymeric coating is formed from one or more of polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (ePTFE), ethylene tetrafluoroethylene (ETFE), nylon, polyethylene, poly ether block amide, bi-oriented polypropylene, cast polypropylene, thermoplastic, polyurethane, ultra-high-molecular-weight polyethylene (UHMWPE), high-molecular-weight polyethylene (HMWPE), or polyether ether ketone (PEEK).

[0595] Example 186. A method comprising: fabricating a valve positioning structure, wherein fabricating the valve positioning structure comprises: forming a support structure, the support structure formed from one of a plastically expandable metal or a shape-memory material shape-set in an at least partially radially expanded shape; forming a polymeric coating on the support structure in the at least partially radially expanded state; mounting the valve positioning structure in the at least partially radially expanded state around a catheter balloon; and crimping the valve positioning structure from the at least partially radially expanded state to a radially compressed state around the catheter balloon.

[0596] Example 187. The method of any example herein, particularly Example 186, wherein the at least partially radially expanded state is a semi-expanded state.

[0597] Example 188. The method of any example herein, particularly Example 186, wherein the at least partially radially expanded state is a fully expanded state.

[0598] Example 189. The method of any example herein, particularly any one of Examples 186-188, wherein the polymeric coating is a closed-cell polymeric coating.

[0599] Example 190. The method of any example herein, particularly any one of Examples 186-188, wherein the polymeric coating is an open-cell polymeric coating.

[0600] Example 191. The method of any example herein, particularly any one of Examples 186-190, wherein the support structure is a frame formed from the shape-memory material shape-set in the at least partially radially expanded state.THVMC-23950W001

[0601] Example 192. The method of any example herein, particularly any one of Examples 186-190, wherein the support structure is a frame formed from the plastical...

Claims

THVMC-23950W001WE CLAIM:

1. A method comprising : placing a support structure of a valve positioning structure in an at least partially radially expanded state; forming a webbing portion of polymeric coating spanning across selected cells of a plurality of cells of the support structure while the support structure is in the at least partially radially expanded state to form a closed-cell polymeric coating on the support structure; mounting the valve positioning structure over a balloon of a balloon catheter; and connecting the valve positioning structure to the balloon catheter such that the valve positioning structure can radially expand and collapse upon inflation and deflation of the balloon, respectively.

2. The method of claim 1, wherein the at least partially radially expanded state is a partially radially expanded state.

3. The method of claim 1, wherein the at least partially radially expanded state is a fully expanded state.

4. The method of any one of claims 1-3, wherein the support structure comprises a frame comprising a plurality of interconnected struts defining the plurality of cells.

5. The method of claim 4, wherein the frame is formed from laser-cut Nitinol.

6. The method of any one of claims 1-3, wherein the support structure comprises a braided mesh structure comprising a plurality of braided wires defining the plurality of cells.

7. The method of claim 6, wherein the braided mesh structure is formed from Nitinol wires.THVMC-23950W0018. The method of either of claim 6 or claim 7, wherein the valve positioning structure further comprises an elastic layer extending over at least a portion of an exterior surface of the braided wires.

9. The method of any one of claims 1-7, wherein the support structure is shapeset in a radially collapsed state.

10. The method of either of claim 8 or claim 9, wherein the placing the support structure of the valve positioning structure in the at least partially radially expanded state comprises mounting the support structure onto a retaining device so that the retaining device extends axially through a central lumen of the support structure.

11. The method of claim 10, wherein the forming the webbing portion of polymeric coating comprises positioning or forming a first polymeric layer on an exterior surface of the retaining device prior to mounting the support structure onto the retaining device, the first polymeric layer extending over an interior surface of the support structure when the support structure is mounted on the retaining device, wherein the positioning or forming the first polymeric layer on the exterior surface of the retaining device comprises one or more of spray coating the exterior surface of the retaining device, dip coating the exterior surface of the retaining device, or wrapping a polymeric material sheet over the exterior surface of the retaining device.

12. The method of claim 11 , further comprising positioning or forming a second polymeric layer over an exterior surface of the support structure while the support structure is mounted on the retaining device, wherein the positioning or forming the second polymeric layer comprises one or more of spray coating the exterior surface of the support structure, dip coating the exterior surface of the support structure, or wrapping a polymeric material sheet over the exterior surface of the support structure.

13. The method of claim 10, further comprising forming a first polymeric layer on an interior surface of the support structure by spray coating the interior surface with a polymeric material, wherein the forming the webbing portion of polymeric coating comprisesTHVMC-23950W001 forming a second polymeric layer over an exterior surface of the support structure by one or more of dip coating the support structure while mounted on the retaining device or wrapping a polymeric material sheet over the exterior surface of the support structure while mounted on the retaining device.

14. The method of any one of claims 12 or 13, further comprising heating the support structure mounted on the retaining device at a temperature that is above a melting temperature of polymeric material to bond the first polymeric layer and the second polymeric layer, wherein the bonding of the first polymeric layer and the second polymeric layer results in encapsulation of the support structure.

15. The method of any one of claims 1-7, wherein the support structure is shapeset in the at least partially radially expanded shape, and the forming the webbing portion of polymeric coating comprises dip coating the support structure, wherein the dip coating results encapsulation of at least a portion of the support structure.

16. The method of any one of claims 1-15, wherein the closed-cell polymeric coating is formed from one or more of polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (ePTFE), ethylene tetrafluoroethylene (ETFE), nylon, polyethylene, polyether block amide, bi-oriented polypropylene, cast polypropylene, thermoplastic, polyurethane, ultra-high-molecular-weight polyethylene (UHMWPE), high-molecular-weight polyethylene (HMWPE), or poly ether ether ketone (PEEK).

17. A method of fabricating a valve positioning structure having an open-cell polymeric coating, the method comprising: forming a support structure of the valve positioning structure such that it is shape-set in a radially collapsed state, the support structure comprising a plurality of cells; and forming a polymeric coating over interior and exterior surfaces of the support structure while the support structure is in the radially collapsed state, the forming the polymeric coating resulting in a portion of the support structure being encapsulated in the polymeric coating with the cells of the support structure open.THVMC-23950W00118. The method of claim 17, wherein the forming the polymeric coating over the interior and exterior surfaces of the support structure comprises spray coating the interior and exterior surfaces of the support structure such that support structure is encapsulated and the plurality of cells are open.

19. The method of claim 17, wherein the forming the polymeric coating over the interior and exterior surfaces of the support structure comprises dip coating the support structure while in the radially collapsed state, and removing a webbing portion from each of the plurality of cells of the support structure after the dip coating such that support structure is encapsulated and the plurality of cells are open.

20. The method of claim 17, wherein the forming the polymeric coating over the interior and exterior surfaces of the support structure comprises at least one of spray coating or dip coating the support structure while it is engaged with a blocking structure, the blocking structure including a plurality raised portions that extend into the cells of the support structure.

21. A delivery apparatus for a prosthetic heart valve, the delivery apparatus comprising: a shaft; a balloon mounted on a distal end portion of the shaft; and a valve positioning structure mounted over the balloon, the valve positioning structure comprising: a support structure comprising at least one of a frame or a wire mesh structure, the support structure defining a plurality of cells; and a closed-cell polymeric coating encapsulating at least a portion of the support structure, wherein a webbing portion of the closed-cell polymeric coating is configured to form one or more folds when the support structure is in a radially collapsed state and is configured to be resistant to tearing when the support structure is transitioned from the radially collapsed state to a radially expanded state.THVMC-23950W00122. The delivery apparatus of claim 21, wherein the webbing portion of the closed-cell polymeric coating is formed while the support structure is an at least partially expanded state such that the webbing portion has a width that prevents overstretching thereof when the support structure is transitioned from the radially collapsed state to the radially expanded state.

23. The delivery apparatus of either of claim 21 or claim 22, wherein the support structure is formed from a shape-memory material and is shape-set in the radially collapsed state.

24. The delivery apparatus of either of claim 21 or claim 22, wherein the support structure is formed from a shape-memory material and is shape-set in a fully radially expanded state.

25. The delivery apparatus of either of claim 21 or claim 22, wherein the support structure is formed from a shape-memory material and is shape-set in a partially radially expanded state.

26. The delivery apparatus of either of claim 21 or claim 22, wherein the support structure is formed from a plastically expandable metal.

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