Delivery apparatus and methods for a balloon-expandable prosthetic device

Abstract

Delivery apparatuses and inflatable balloons for delivery apparatuses are disclosed. A delivery apparatus for a prosthetic device can comprise a handle, a shaft extending distally from the handle, and an inflatable balloon arranged around a distal end portion of the shaft and configured to inflate from a deflated state to an inflated state. In the deflated state, the inflatable balloon comprises a central cavity surrounding the shaft and a plurality of pleats extending outward from the central cavity, where each pleat of the plurality of pleats is shaped and folded against the central cavity such that when the balloon inflates, the pleats expand away from the shaft in a radially outward direction without causing the balloon to rotate relative to the shaft.

Description

DELIVERY APPARATUS AND METHODS FOR A BALLOON-EXPANDABLE PROSTHETIC DEVICECROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U. S. Provisional Patent Application Nos.63 / 737,398, filed December 20, 2024, and 63 / 764,138, filed February 27, 2025, which are incorporated by reference herein in their entireties.FIELD

[0002] The present disclosure relates to apparatuses, systems, and methods for rotationally orienting a balloon-expandable prosthetic valve, or other prosthetic device, relative to native anatomy and maintaining the rotational orientation during radial expansion and deployment of the prosthetic valve with a delivery apparatus.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 (e.g., 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 of a delivery apparatus and advanced through the patient’s vasculature (e.g., through a femoral artery and the aorta) until the prosthetic valve reaches the implantation site in the heart. The prosthetic valve is then expanded to its functional size, for example, by inflating a balloon on which the prosthetic valve is mounted, actuating a mechanical actuator that applies an expansion force to the prosthetic valve, or by deploying the prosthetic valve from a sheath of the delivery apparatus so that the prosthetic valve can self-expand to its functional size.

[0004] It may be desirable to deploy the prosthetic valve at the native valve using the delivery apparatus such that commissures of the prosthetic valve are aligned with commissures of the native valve. However, such alignment can be complicated and timeconsuming for inflatable balloon delivery apparatuses. Accordingly, a need exists for improved inflatable balloon delivery apparatuses and methods that can effectively deploy the prosthetic heart valve via an inflatable balloon such that the prosthetic valve is implanted in a desired orientation relative to the native anatomy.SUMMARY

[0005] Described herein are prosthetic heart valves, delivery apparatus, and methods for implanting prosthetic heart valves. In some examples, the prosthetic valve can be mounted in a radially compressed (or collapsed) state onto a delivery apparatus for delivery to a target implantation site and then deployed at the target implantation site (e.g., the native valve) with the delivery apparatus. The delivery apparatus can include an inflatable balloon. In some examples, the prosthetic valve can be mounted around the balloon in a collapsed state. In some examples, the prosthetic valve can be mounted off the balloon in a collapsed state and then moved onto the balloon at or proximate to the implantation site. The prosthetic valve is radially expanded and deployed by inflating the balloon at the target implantation site.

[0006] In some examples, the balloon is arranged around a distal end portion of a shaft of the delivery apparatus and the balloon comprises a proximal leg, a distal leg, and an inflatable body extending between the proximal leg and distal leg. The inflatable body of the balloon can comprise a plurality of pleats that are folded against one another and spiral around the shaft in a first circumferential direction. In some examples, the balloon can be shaped with a twist such that the distal leg is twisted in a second circumferential direction, away from the proximal leg by a specified amount. This balloon twist can be referred to herein as a “negative twist” since the distal leg is twisted in an opposite direction than the “positive” twisting direction of the balloon pleats. When the balloon is inflated, the direction of its pleats urges the balloon to rotate in the second circumferential direction as they unfurl.However, the negative twist of the balloon urges the balloon to rotate in the first circumferential direction, thereby negating the rotation from the pleats. As a result, the position of the balloon in its inflated state may not be rotated relative to the position of the balloon in its deflated state, and the prosthetic valve can be radially expanded and deployed in an intended circumferential orientation relative to the native anatomy (without rotating between its radially collapsed and radially expanded configurations).

[0007] In some examples, the pleats of the balloon are shaped and / or pleated such that the balloon does not rotate as it is inflated and / or an inflated state of the balloon is not rotatedrelative to its deflated state. For example, the pleats can be shaped and arranged around a central cavity of the balloon such that there is no directional bias to the pleats and / or they expand directly radially outward (without moving in the circumferential direction) during inflation of the balloon. As a result, the balloon and the prosthetic valve mounted thereon do not rotate during inflation of the balloon and deployment of the prosthetic valve (and / or the balloon and prosthetic valve are not rotated in their radially expanded configurations, postinflation, relative to their radially collapsed configurations, pre-inflation).

[0008] In some examples, the prosthetic valve can be uncoupled or spaced radially apart from the balloon by a sleeve or covering and / or a lubricating layer disposed therebetween. As such, rotation of the balloon during inflation may not be transferred to the prosthetic valve, thereby preventing the prosthetic valve from rotating during radial expansion and deployment.

[0009] In some examples, one or more holding devices of the delivery apparatus can couple to the prosthetic valve, when the valve is radially collapsed around the balloon, and hold onto the prosthetic valve and prevent it from rotating, even as the balloon rotates during inflation. The one or more holding devices can be configured to stretch or radially expand as the prosthetic valve radially expands during inflation of the balloon. In some examples, the one or more holding devices are retractable.

[0010] In some examples, a distal tip of an outer shaft the delivery apparatus, which is axially movable relative to the balloon, can comprise mating features that are configured to coupled to a proximal end of the prosthetic valve and hold it rotationally in place as the balloon inflates and radially expands.

[0011] In some examples, a portion of the distal end portion of the delivery apparatus can comprise a radially outwardly extending protrusion proximal to a body portion of the balloon. When the prosthetic valve is moved over the protrusion onto the body portion of the balloon, it is partially radially expanded by the protrusion. As such, a gap is created between the inner surface of the prosthetic valve and the body portion of the balloon. Thus, as the balloon is inflated and its pleats unfurl, the unfurling pleats do not contact the prosthetic valve enough to cause it to rotate.

[0012] In some examples, the balloon is a composite or multi-part balloon assembly that comprises two or more balloons that are assembled together. Each balloon can be pleated individually into two or more pleats which are more likely to expand directly radiallyoutwardly as the balloon portion inflates. In some examples, the pleats of the different balloons may counteract each other’s tendency to rotate during unfurling. As a result, a prosthetic valve mounted thereon may not rotate, or a rotational position of the prosthetic valve pre- and post-balloon inflation may be the same.

[0013] Thus, the disclosed inflatable balloons, delivery apparatuses, and methods can, for example, provide a way to radially expand and deploy a prosthetic valve at an implantation site, while maintaining a circumferential orientation of the prosthetic valve relative to the native anatomy and delivery apparatus. Said another way, the inflatable balloons, delivery apparatuses, and methods described herein can prevent the prosthetic valve from rotating (or being rotated between its pre and post deployment states), even if the balloon rotates. As such, the devices and methods disclosed herein can, among other things, overcome one or more of the deficiencies of typical prosthetic heart valves and their delivery apparatuses.

[0014] A delivery apparatus for a prosthetic implant can comprise one or more shafts and an inflatable balloon arranged around a distal end portion of at least one shaft of the one or more shafts.

[0015] In some examples, the delivery apparatus can comprise a handle, and the one or more shafts can extend distally from the handle.

[0016] In some examples, the inflatable balloon is arranged around a distal end portion of a first shaft of the one or more shafts and is configured to inflate from a deflated state to an inflated state.

[0017] In some examples, in the deflated state, the inflatable balloon comprises a central cavity surrounding the shaft and a plurality of pleats extending outward from the central cavity, where each pleat of the plurality of pleats is folded such that when the balloon inflates, the pleats expand away from the shaft in a radially outward direction and unfold without rotating an implant mounted on the balloon relative to the shaft.

[0018] In some examples, each pleat is T-shaped.

[0019] In some examples, each pleat is folded over itself a plurality of times to form a stack of zig-zagging folds that extends radially away from the central cavity.

[0020] In some examples, each pleat has a spiral shape that spirals in a circumferential direction toward the central cavity.

[0021] In some examples, each pleat of a first half of the plurality of pleats curves in a first direction around a central longitudinal axis of the balloon and each pleat of a second half ofthe plurality of pleats curves in a second direction around the central longitudinal axis, wherein the second direction is opposite the first direction.

[0022] In some examples, each pleat of the plurality of pleats does not have a directional bias in the circumferential direction.

[0023] In some examples, the inflatable balloon comprises a proximal leg, a distal leg, and an intermediate portion extending between the proximal leg and distal leg, and the inflatable balloon comprises a plurality of pleats that are folded against one another and spiral around the shaft in a first circumferential direction.

[0024] In some examples, the inflatable balloon is shaped with a twist such that the distal leg is twisted in a second circumferential direction away from the proximal leg, the second circumferential direction opposite the first circumferential direction.

[0025] In some examples, the delivery apparatus can comprise one or more holding members configured to couple to an end of a prosthetic valve mounted around the inflatable balloon and hold the prosthetic valve rotationally in place as the balloon inflates to the inflated state.

[0026] In some examples, each holding member of the one or more holding members is configured to move radially outward as the balloon inflates and prosthetic valve radially expands.

[0027] In some examples, the delivery apparatus can comprise a polymeric sleeve arranged around at least a portion of the inflatable balloon in both the deflated state and the inflated state.

[0028] In some examples, a shaft of the delivery apparatus can comprise a distal tip with mating features that are configured to engage a prosthetic device mounted a distal end portion of the delivery apparatus and to prevent rotation of the prosthetic device.

[0029] In some examples, the delivery apparatus can comprise a protrusion offset from a body portion of the inflatable balloon in a proximal direction, where the protrusion extends radially outward relative to a central longitudinal axis of the delivery apparatus, and where a portion of the delivery apparatus disposed proximal to the protrusion is configured to receive a prosthetic valve mounted thereon in a radially collapsed configuration.

[0030] In some examples, a delivery apparatus comprises a handle; a shaft extending distally from the handle; and an inflatable balloon arranged around a distal end portion of the shaft and configured to inflate from a deflated state to an inflated state. In the deflated state, the inflatable balloon comprises a central cavity surrounding the shaft and a plurality of pleats.Each pleat of the plurality of pleats is folded such that when the balloon inflates, the pleats expand away from the shaft in a radially outward direction and unfold without rotating an implant mounted on the balloon relative to the shaft.

[0031] In some examples, a delivery apparatus comprises a shaft; and an inflatable balloon arranged around a distal end portion of the shaft. The inflatable balloon comprises a proximal leg, a distal leg, and an inflatable body extending between the proximal leg and distal leg. The inflatable balloon comprises a plurality of pleats that are folded against one another around the shaft in a first circumferential direction. The distal leg is circumferentially offset from the proximal leg such that the balloon is twisted in a second circumferential that is opposite the first circumferential direction.

[0032] In some examples, a delivery apparatus comprises a shaft: and an inflatable balloon arranged around a distal end portion of the shaft and configured to inflate from a deflated state to an inflated state. The inflatable balloon comprises a central cavity and plurality of circumferentially spaced apart pleats branching radially outward from the central cavity in the deflated state. Each pleat has a compressed shape that is configured to expand radially outward when the balloon transitions from the deflated state to the inflated state such that a net rotational force imparted by the balloon on a prosthetic valve mounted thereon during balloon inflation is zero.

[0033] In some examples, a delivery apparatus comprises a first shaft; a second shaft extending through the first shaft with a distal end portion that extends distally beyond a distal end of the first shaft; an inflatable balloon arranged around the distal end portion of the second shaft and coupled to the distal end of the first shaft, where the inflatable balloon is configured to inflate from a compressed and deflated state to an expanded and inflated state; and a polymeric sleeve arranged around at least a portion of the inflatable balloon in both the deflated state and the inflated state.

[0034] In some examples, a delivery apparatus comprises a shaft; and an inflatable balloon arranged around a distal end portion of the shaft and configured to inflate from a deflated state to an inflated state; and one or more holding members configured to couple to an end of a prosthetic valve arranged around the balloon and hold the prosthetic valve rotationally in place as the balloon inflates to the inflated state. Each holding member of the one or more holding members is configured to move radially outward as the balloon inflates and prosthetic valve radially expands.

[0035] In some examples, a delivery apparatus comprises a handle; a shaft extending distally from the handle; and an inflatable balloon arranged around a distal end portion of the shaft and configured to inflate from a deflated and compressed state to an inflated state. In the deflated and compressed state, the inflatable balloon comprises a central cavity surrounding the shaft and a plurality of pleats extending outward from the central cavity, where the plurality of pleats are grouped into pairs of adjacently arranged pleats, each pair comprising a first pleat that forms a spiral that extends radially outward from the central cavity and spirals in a first circumferential direction about an axis that is parallel to but radially spaced from a central longitudinal axis of the balloon and a second pleat that forms a spiral that extends radially outward from the central cavity and spirals in a second circumferential direction about an axis that is parallel to but radially spaced from the central longitudinal axis of the balloon. The second circumferential direction is opposite the first circumferential direction.

[0036] In some examples, a delivery apparatus comprises a first shaft comprising a distal tip, where the distal tip has an end portion with mating features that are configured to engage a prosthetic device mounted on a distal end portion of the delivery apparatus and prevent rotation of the prosthetic device. The delivery apparatus comprises a second shaft extending through the first shaft and having a distal end portion extending distally beyond the distal tip of the first shaft, and an inflatable balloon arranged around the distal end portion of the second shaft.

[0037] In some examples, a delivery apparatus comprises a handle, a first shaft extending distally from the handle, a second shaft extending distally from the handle and through the first shaft and having a distal end portion extending distally beyond a distal end of the first shaft, an inflatable balloon arranged around the distal end portion of the second shaft, and a protrusion offset from a body portion of the inflatable balloon in a proximal direction. The protrusion extends radially outward relative to a central longitudinal axis of the delivery apparatus, and a portion of the delivery apparatus disposed proximal to the protrusion is configured to receive a prosthetic valve mounted thereon in a radially collapsed configuration.

[0038] In some examples, a delivery apparatus comprises an inflatable balloon assembly comprising two or more balloons coupled together, where each balloon of the two or more balloons comprises an outer surface, and a mating surface and a partial channel depressed into the mating surface. The two or more balloons engage each other at their respectivemating surfaces to form a central channel of the balloon assembly configured to receive a shaft of the delivery apparatus, and the outer surfaces of the balloons define an outer surface of the balloon assembly that has a circular cross-section profile in a plane perpendicular to a central longitudinal axis of the balloon assembly. The delivery apparatus comprises the shaft extending through the central channel of the inflatable balloon assembly.

[0039] In some examples, a delivery apparatus comprises one or more of the components recited in Examples 1-24, 56-61, 63-68, 70-76, 78-85, 108-118, 130-136, 161, 163, and 176-178 below.

[0040] An assembly can comprise the delivery apparatus of an of the examples described above and a prosthetic heart valve mounted in a radially collapsed configuration around the inflatable balloon in the deflated state.

[0041] In some examples, an assembly comprises one or more of the components recited in Examples 25, 62, 69, 77, 86, 119-122, and 137 below.

[0042] A method can comprise arranging a prosthetic device, in a radially collapsed configuration, around a balloon of a delivery apparatus, where the balloon comprises a plurality of pleats that are folded around a central longitudinal axis of the balloon, and where the balloon is in a compressed and deflated configuration.

[0043] In some examples, the method can comprise inflating the balloon to radially expand the prosthetic device such that a rotational position of the prosthetic device, relative to a shaft of the delivery apparatus, after the inflating is the same as a rotational position of the prosthetic device before the inflating.

[0044] In some examples, arranging the prosthetic device around the balloon includes arranging polymeric sleeve around the balloon and arrangi ng the prosthetic device around the polymeric sleeve such that the prosthetic device is separated from the balloon.

[0045] In some examples, the inflating the balloon includes implanting the prosthetic device at an implantation site in a specified rotational position relative to the implantation site.

[0046] In some examples, inflating the balloon includes expanding each pleat of the plurality of pleats directly radially outward from the central longitudinal axis as the balloon inflates.

[0047] In some examples, the method can include, prior to inflating the balloon, rotating the balloon and prosthetic device such that the prosthetic device is in the specified rotational position relative to the implantation site.

[0048] In some examples, the prosthetic device is a prosthetic valve.

[0049] In some examples, the implantation site is a native valve.

[0050] In some examples, the native valve is an aortic valve.

[0051] In some examples, the implantation site is a previously implanted prosthetic valve implanted within a native valve.

[0052] A method can comprise shaping an inflatable balloon of a delivery apparatus into a first shape having a central cavity and a plurality of circumferentially spaced and radially extending sections extending outward from the central cavity.

[0053] In some examples, the method can comprise compressing each radially extending section of the plurality of circumferentially spaced and radially extending sections radially inward toward a central longitudinal axis of the balloon, thereby forming the balloon into a compressed and deflated state having a second shape.

[0054] In some examples, a method comprises arranging a prosthetic device, in a radially collapsed configuration, around a balloon of a delivery apparatus, where the balloon comprises a plurality of pleats that are folded around a central longitudinal axis of the balloon, and where the balloon is in a compressed and deflated configuration. The method further comprises inflating the balloon to radially expand the prosthetic device such that a rotational position of the prosthetic device, relative to a shaft of the delivery apparatus, after the inflating is the same as a rotational position of the prosthetic device before the inflating.

[0055] In some examples, a method comprises shaping an inflatable balloon of a delivery apparatus into a first shape having a central cavity and a plurality of circumferentially spaced and radially extending sections extending outward from the central cavity. The method further comprises compressing each radially extending section of the plurality of circumferentially spaced and radially extending sections radially inward toward a central longitudinal axis of the balloon, thereby forming the balloon into a compressed and deflated state having a second shape.

[0056] In some examples, a method comprises shaping an inflatable balloon of a delivery apparatus into a first shape, where the first shape is a polygonal shape having four sides; folding corners of polygonal shaped balloon radially inward toward a central longitudinal axis of the balloon; and inserting the folded balloon into a forming mold and shaping the inflatable balloon into a second shape comprising a central cavity and a plurality of circumferentially spaced apart wings that extend radially outward from the central cavity.Each wing has an attached end attached to the central cavity and a free end spaced radially away from the central cavity, where the free end is wider than the attached end.

[0057] In some examples, a method comprises pleating and folding a balloon to create a plurality of pleats that wrap around a central cavity of the balloon in a first circumferential direction; and twisting the balloon such that a distal leg of the balloon is circumferentially offset from a proximal leg of the balloon in a second circumferential direction that is opposite the first circumferential direction. The balloon comprises an intermediate portion disposed between the proximal leg and distal leg.

[0058] In some examples, a method comprises engaging mating features of a distal tip of a first shaft of a delivery apparatus to a proximal end of a prosthetic device arranged around an inflatable balloon of the delivery apparatus in a radially collapsed configuration, where the inflatable balloon is mounted around a second shaft of the delivery apparatus that extends through the first shaft. The method comprises inflating the inflatable balloon a first amount while the distal tip holds the prosthetic device in place in a rotational direction, retracting the distal tip proximally, away from the prosthetic device, and inflating the inflatable a second amount to radially expand and deploy the prosthetic device at an implantation site.

[0059] In some examples, a method comprises advancing a distal end portion of a delivery apparatus toward an implantation site, where a prosthetic valve is mounted on the distal end portion, proximal to an inflatable balloon of the delivery apparatus and proximal to a protrusion that extends radially outward from a shaft of the delivery apparatus around which the inflatable balloon is arranged. The method comprises axially moving the prosthetic valve over the protrusion and onto the inflatable balloon, and partially radially expanding the prosthetic valve as it moves over the protrusion. The method comprises inflating the inflatable balloon without rotating the prosthetic valve.

[0060] In some examples, a method comprises one or more of the features recited in Examples 26-55, 87-107, 123-129, 138-144, 162, and 173-175 below.

[0061] The above method(s) can be performed on a living animal or on a simulation, such as on a cadaver, cadaver heart, anthropomorphic ghost, or simulator (e.g., with body parts, heart, tissue, etc. being simulated).

[0062] In some examples, an inflatable balloon assembly for a delivery apparatus comprises two or more balloons coupled together, where each balloon of the two or more balloons comprises an outer surface and a mating surface and a partial channel depressed into themating surface. The two or more balloons engage each other at their respective mating surfaces to form a central channel of the balloon assembly configured to receive a shaft of the delivery apparatus, and the outer surfaces of the balloons define an outer surface of the balloon assembly that has a circular cross-section profile in a plane perpendicular to a central longitudinal axis of the balloon assembly

[0063] In some examples, an inflatable balloon assembly comprises one or more of the components recited in Examples 145-160 below.

[0064] In some examples, a folding tool for folding an inflatable balloon comprises a first body having a first end and an opposing, second end, the first body comprising a central bore extending axially through the first body from the first end to the second end of the first body, and a plurality of channels spaced circumferentially apart around the central bore. Each channel extends radially outward from the central bore and extends axially from the first end to the second end of the first body. A shape of each channel changes along its length, between the first end and the second end. At the first end of the first body, the central bore is configured to receive a central portion of an inflatable balloon and each channel is configured to receive a respective pleat of the inflatable balloon.

[0065] In some examples, a folding tool comprises one or more of the components recited in Examples 162-172 below.

[0066] 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

[0067] FIG. 1 is a perspective view of a prosthetic heart valve, according to an example.

[0068] FIG. 2 is a side view of a delivery apparatus for implanting a prosthetic heart valve, according to an example.

[0069] FIG. 3 A is a cross-sectional view of the handle of the delivery apparatus of FIG. 2.

[0070] FIG. 3B is another cross-sectional view of the handle of the delivery apparatus of FIG. 2.

[0071] FIG. 4 is side view of a section of the handle and a section of the distal end portion of the delivery apparatus of FIG. 2.

[0072] FIG. 5A is a side view of the distal end portion of the delivery apparatus of FIG. 2.

[0073] FIG. 5B is a cross-sectional side view of the distal end portion of the delivery apparatus of FIG. 2.

[0074] FIG. 6 is a cross-sectional view of an exemplary inflatable balloon for a delivery apparatus in a deflated state, with pleats that are pleated in one direction that spirals or curves around a central longitudinal axis of the balloon.

[0075] FIG. 7 is a side view of an inflatable balloon, prior to shaping into a deflated and compressed state, where the balloon has a proximal twist mark on its proximal leg and a distal twist mark on its distal leg which are aligned a central longitudinal axis of the balloon.

[0076] FIG. 8 is a side view of the balloon of FIG. 7, after shaping it into the deflated and compressed state, showing the distal twist mark circumferentially offset from the proximal twist mark, thereby indicating a negative twist on the formed balloon.

[0077] FIG. 9A is a side view of an inflatable balloon in a deflated and compressed state, with zero twist induced on the balloon during balloon shaping.

[0078] FIG. 9B is a side view of an inflatable balloon in a deflated and compressed state, with negative twist induced on the balloon during balloon shaping.

[0079] FIG. 9C is a side view of an inflatable balloon in a deflated and compressed state, with positive twist induced on the balloon during balloon shaping.

[0080] FIG. 10A depicts a first stage of a balloon manufacturing process where a body of the balloon is pleated and folded.

[0081] FIG. 10B depicts a second stage of the balloon manufacturing process where the balloon is twisted and a proximal cone of the balloon of FIG. 10A is compressed.

[0082] FIG. 10C depicts a second phase of the second stage of the balloon manufacturing process where the body of the balloon is compressed.

[0083] FIG. 11 A is side view of a delivery apparatus including a first inflatable balloon with zero twist between its proximal and distal legs.

[0084] FIG. 1 IB is a side view of a delivery apparatus including a second inflatable balloon with a negative twist between its proximal end distal legs.

[0085] FIG. 12 is a cross-sectional end view of an exemplary inflatable balloon formed into the deflated and compressed state with a plurality of T-shaped pleats that branch off from a central cavity of the balloon.

[0086] FIG. 13A is a cross-sectional end view of an exemplary inflatable balloon comprising a plurality of stacked pleats in the deflated and compressed state.

[0087] FIG. 13B is a perspective view of the inflatable balloon of FIG. 13 A.

[0088] FIG. 14A is a cross-sectional end view of an exemplary inflatable balloon in a deflated state, where the balloon comprises a plurality of spiral pleats.

[0089] FIG. 14B is a cross-sectional end view of the balloon of FIG. 14A in a partially inflated state, where the spiral pleats are unfurled into triangular shaped sections.

[0090] FIG. 15A is a cross-sectional end view of an exemplary inflatable balloon in a deflated state, where the balloon comprises three pairs of spiral pleats that spiral is opposing directions.

[0091] FIG. 15B is a cross-sectional end view of the balloon of FIG. 15A in a partially inflated state, where the spiral pleats are unfurled into triangular shaped sections.

[0092] FIG. 16 is a cross-sectional end view of an exemplary inflatable balloon having two groups of pleats, including a first group of pleats that curve or arc around a central cavity of the balloon in a first direction and a second group of pleats that curve or arc around the central cavity in an opposite, second direction.

[0093] FIG. 17 is a cross-sectional end view of an exemplary inflatable balloon comprising a plurality of zig-zagging pleats that individually branch off from a central cavity of the balloon.

[0094] FIG. 18A is a cross-sectional end view of an exemplary inflatable balloon formed with a plurality of bulbous or petal-shaped sections that each extend radially outward from a central cavity of the balloon.

[0095] FIG. 18B is a cross-sectional end view of the balloon of FIG. 18 A, compressed into the deflated state, thereby resulting in a plurality of T-shaped sections.

[0096] FIG. 19 is a perspective view of an exemplary inflatable balloon that is initially formed into a polygon shaped balloon.

[0097] FIG. 20 is a perspective view of forming mold that is configured to receive the polygon shaped balloon of FIG. 19, after folding in the comers of the balloon, to perform a secondary formation or reformation on the balloon.

[0098] FIG. 21 is a cross-sectional end view of the final formed balloon resulting from the secondary formation with the forming mold of FIG. 20.

[0099] FIG. 22A is a perspective view of an exemplary balloon with an origami-like pleat design that has no orientation or direction bias.

[0100] FIG. 22B is a perspective view of an exemplary balloon with an origami-like pleat design that has no orientation or direction bias.

[0101] FIG. 23 is a perspective view of an exemplary balloon comprising a plurality of circumferentially extending rows of angled pleats, where the pleats of adjacent rows of pleats angle in different directions.

[0102] FIG. 24 is a perspective view of an exemplary balloon comprising a plurality of circumferentially extending rows of zig-zagging pleats.

[0103] FIG. 25A is a side view of a distal end portion of a delivery apparatus with a polymeric sleeve arranged over at least a portion of a body of an inflatable balloon.

[0104] FIG. 25B is a side view of the distal end portion of the delivery apparatus of FIG. 25 A, with a lubricating coating arranged between the inflatable balloon and the polymeric sleeve.

[0105] FIG. 26 is a side view of a distal end portion of a delivery apparatus with one or more holding devices coupled to an end of a prosthetic valve mounted around an inflatable balloon and configured to hold the valve rotationally in place as the balloon inflates.

[0106] FIG. 27 is a side view of a distal end portion of a delivery apparatus with one or more expandable frames coupled to an end of a prosthetic valve mounted around an inflatable balloon and configured to hold the valve rotationally in place as the balloon inflates.

[0107] FIG. 28 is a flow chart of a method for shaping an inflatable balloon and / or deploying a prosthetic device without rotating the prosthetic device during deployment with a delivery apparatus that includes the inflatable balloon.

[0108] FIG. 29 is a cross-sectional view of a die used to form a balloon with bulbous-shaped pleats.

[0109] FIG. 30 is a cross-sectional view of a pleated balloon comprising a plurality of bulbous -shaped pleats created with the die of FIG. 29.

[0110] FIG. 31 is a cross-sectional view of the balloon of FIG. 30 in a compressed and / or folded state where the pleats have been radially compressed and set into T-shaped pleats.

[0111] FIG. 32 is a cross-sectional view of a die used to form a balloon with double bulbed-shaped pleats that extend radially outward from a central cavity of the balloon.

[0112] FIG. 33 is a magnified view of FIG. 32 showing the pleated balloon shaped using the die of FIG. 32.

[0113] FIG. 34 is a cross-sectional view of the balloon of FIG. 33 in a compressed and / or folded state where the pleats have been radially compressed and set into double T-shaped pleats.

[0114] FIG. 35 is a cross-sectional view of a die used to shape a balloon into a balloon shape having a plurality of zigzag shaped pleats.

[0115] FIG. 36A is a cross-sectional view of a die used to shape a balloon into a balloon shape having an approximate shape of a number sign with pairs of perpendicularly extending pleats, where the die is in a first, expanded state prior to shaping the balloon pleats.

[0116] FIG. 36B is the cross-sectional view of the die of FIG. 36A in a second, compressed state that shapes the pleats of the balloon.

[0117] FIG. 37 is a cross-sectional view of the pleated balloon shaped with the die shown in FIG. 36.

[0118] FIG. 38 is a side view of the balloon of FIG. 37 after folding and / or radially compressing it into the deflated and compressed state.

[0119] FIG. 39 is a cross-sectional view of a cone section of the balloon of FIG. 38.

[0120] FIG. 40 is a cross-sectional view of a main body portion of the balloon of FIG. 38.

[0121] FIG. 41 is a cross-sectional side view of a distal end portion of a delivery apparatus including a distal tip arranged at a distal end of an outer shaft of the delivery apparatus.

[0122] FIG. 42 is a side view of a portion of the distal end portion of the delivery apparatus of FIG. 41, where the distal tip comprises mating features configured to interface with a prosthetic device arranged around the distal end portion of the delivery apparatus.

[0123] FIG. 43 is a cross-sectional side view of a portion of a delivery apparatus which includes a protrusion configured to partially radially expand a prosthetic device as it moves over the protrusion onto an inflatable balloon of the delivery apparatus, where the prosthetic device is initially arranged proximal to the protrusion.

[0124] FIG. 44 is a cross-sectional side view of the delivery apparatus of claim 43, with the prosthetic device arranged distal to the protrusion and around the inflatable balloon.

[0125] FIG. 45A is an exploded side view of a multi-part balloon assembly for a delivery apparatus.

[0126] FIG. 45B is an assembled perspective view of the multi-part balloon assembly of FIG.45A.

[0127] FIG. 46 is an assembled perspective view of the multi-part balloon assembly of FIG.45 A, with internal structures depicted with dashed lines.

[0128] FIG. 47 is a cross-sectional side view of the assembled multi-part balloon assembly of FIG. 45A with a reinforcing member inside a central channel of the multi-part balloon.

[0129] FIG. 48A is an end view of the assembled multi-part balloon assembly of FIG. 45 A.

[0130] FIG. 48B is an end view of a multi-part balloon assembly comprising three balloons.

[0131] FIG. 48C is an end view of a multi-part balloon assembly comprising four balloons.

[0132] FIG. 48D is an end view of a multi-part balloon assembly comprising five balloons.

[0133] FIG. 49 is a cross-sectional end view of a half-cylinder balloon of the multi-part balloon assembly of FIG. 45A split into three sections for pleating and folding.

[0134] FIG. 50 is a side view of a portion of the half-cylinder balloon of FIG. 49 in a pleated and folded configuration.

[0135] FIG. 51 A is a cross-sectional end view of a half-cylinder balloon of the multi-part balloon assembly of FIG. 45A split into four sections for pleating and folding.

[0136] FIG. 5 IB is a cross-sectional end view of the half-cylinder balloon of FIG. 51 A wherein the sections are being pleated and folded to form four pleats.

[0137] FIG. 52 is a side view of a portion of the half-cylinder balloon of FIGS. 51 A and 51B that has been pleated and folded into four pleats.

[0138] FIG. 53A is a side view of a portion of a half-cylinder balloon of the multi-part balloon assembly of FIG. 45 A that has been pleated and folded into six pleats and is in a radially compressed and deflated configuration.

[0139] FIG. 53B is a side view of the half-cylinder balloon of FIG. 53A in a radially expanded and at least partially inflated configuration.

[0140] FIG. 54 is a cross-sectional view of a die in a compressed state that shapes a balloon into a balloon shape having a plurality of pairs of L-shaped pleats.

[0141] FIG. 55 A is a cross-sectional view of the shaped balloon from FIG. 54.

[0142] FIG. 55B is a cross-sectional view of the shaped balloon from FIG. 55A in a first stage of folding a first set of two pairs of opposing L-shaped pleats.

[0143] FIG. 55C is a cross-sectional view of the L-shaped balloon from FIG. 55B in a second stage of folding a second set of two pairs of opposing L-shaped pleats.

[0144] FIG. 56 is a cross-sectional view of a balloon with pleats folded into an exemplary folding pattern.

[0145] FIG. 57 is a cross-sectional view of a balloon with pleats folded into another exemplary folding pattern.

[0146] FIG. 58 is a perspective, exploded view of an exemplary folding tool for folding pleats of a balloon.

[0147] FIG. 59 is a cross-sectional side view of the folding tool of FIG. 58.

[0148] FIG. 60A is a cross-sectional end view of the first body of the folding tool of FIG. 59, taken at the first end of the first body.

[0149] FIG. 60B is a cross-sectional end view of the first body of the folding tool of FIG. 59, taken at an intermediate portion of the first body.

[0150] FIG. 60C is a cross-sectional end view of the first body of the folding tool of FIG. 59, taken at the second end of the first body.

[0151] FIG. 61 is a perspective view from the proximal end of a second body of the folding tool of FIG. 58.DETAILED DESCRIPTIONGeneral Considerations

[0152] 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 constmed as being limiting in any way. Instead, the present disclosure 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.

[0153] 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.

[0154] 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.

[0155] 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 (e.g., 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 (e.g., 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.

[0156] As used herein, “e.g.” means “for example,” and “i.e.” means “that is.”Overview of the Disclosed Technology

[0157] 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.

[0158] As introduced above, it may be desirable to deploy the prosthetic valve at the native valve using the delivery apparatus such that commissures of the prosthetic valve are aligned with commissures of the native valve (e.g., the native aortic valve). Such an orientation can avoid implantation of the prosthetic valves with commissure arranged in front of a coronary ostium, which can limit future cardiovascular interventions.

[0159] In some examples, radiopaque markers that are visible under medical imaging can be included on the commissures of the prosthetic valve. However, because the folding (or pleating) of the inflatable balloon on the delivery apparatus can cause rotation of the prosthetic valve during radial expansion, rotationally aligning the prosthetic valve using the valve commissure markers when the balloon is uninflated can result in inaccurate positioning of the implanted valve at the native valve upon inflation of the balloon.

[0160] In some examples, radiopaque markers can be included on the delivery apparatus itself. However, because the folding of the inflatable balloon on the delivery apparatus can cause rotation of the prosthetic valve during radial expansion, special accessories and processes are used to account for this rotation and rotationally align the prosthetic valve on the delivery apparatus relative to the radiopaque marker on the delivery apparatus.

[0161] Thus, a delivery apparatus with an inflatable balloon (for radially expanding a prosthetic valve radially compressed thereon) can be configured such that the balloon does not cause rotation of the prosthetic valve between the prosthetic valve’ s radially collapsed configuration (pre-balloon inflation) and its radially expanded configuration (post-balloon inflation). As a result, radiopaque markers on one or more commissures of the prosthetic valve can be used to rotationally align the prosthetic valve relative to the native anatomy, and the prosthetic valve can be implanted in the native anatomy in the desired rotational positioning. That is, the radiopaque markers of the prosthetic valve can be rotationally aligned with the native anatomy when the prosthetic valve is in the radially compressed, delivery state, and the rotational orientation of the prosthetic valve relative to the native anatomy prior to balloon inflation is the same or substantially the same as when the balloon is inflated and the prosthetic valve is deployed / radially expanded. This eliminates the need to rotationally offset a commissure of the prosthetic valve from a radiopaque marker on the delivery apparatus to account for balloon unfurling causing valve rotation during deployment. As a result, special accessories and procedures for mounting the prosthetic valve on thedelivery apparatus in a specified rotational orientation are not needed, thereby saving time and costs prior to and / or during an implantation procedure.

[0162] FIG. 1 is an exemplary prosthetic valve that can be mounted on and delivered by a delivery apparatus, such as the delivery apparatus shown in FIGS. 2-5B. The delivery apparatus can comprise an inflatable balloon arranged around a distal end portion of a shaft of the delivery apparatus. The inflatable balloon is configured to receive a prosthetic valve thereon and radially expand the prosthetic valve during deployment by inflation.

[0163] FIG. 6 depicts an exemplary balloon for a delivery apparatus, such as the delivery apparatus of FIGS. 2-5B, in a deflated state and at least partially folded or compressed state, with pleats that are pleated in a unidirectional spiral or curve around a central longitudinal axis of the balloon, which therefore causes the pleats to rotate as they unfurl and a prosthetic valve mounted thereon to rotate during inflation of the balloon and radial expansion of the prosthetic valve.

[0164] In some examples, rotation of the prosthetic valve during expansion can be prevented by inducing a balloon twist in the balloon during the balloon manufacturing process, as depicted at FIGS. 7-1 IB. For example, by inducing a negative balloon twist, the prosthetic valve rotation from the pleats of the balloon is counteracted. As a result, the prosthetic valve may not rotate during balloon inflation and expansion, as shown in FIG. 1 IB.

[0165] In some examples, the inflatable balloon of a delivery apparatus can be pleated such that the pleats expand directly radially outward (as shown in FIGS. 12-15B and 17-21) or rotate in opposing directions (FIG. 16) such that a prosthetic valve mounted thereon does not rotate during inflation of the balloon and radial expansion of the prosthetic valve.

[0166] In some examples, as shown in FIGS. 22A-24. the inflatable balloon of a delivery apparatus can have a pleat design that results in the pleats having no orientation or directional bias, or groups of pleats that counteract each other’s direction bias, in the circumferential direction. During inflation, such balloons expand uniformly without rotation.

[0167] In some examples, the inflatable balloon of the delivery apparatus can be covered with an elastic polymer (as shown in FIG. 25A) and / or a layer of lubricant (as shown in FIG.25B), thereby separating the prosthetic valve from the balloon and preventing rotation of the prosthetic valve during inflation of the balloon and deployment of the prosthetic valve.

[0168] In some examples, as shown in FIGS. 26 and 27, the delivery apparatus can include various devices or members for holding the prosthetic valve rotationally in place relative tothe delivery apparatus and preventing rotation of the prosthetic valve during balloon inflation. FIGS. 41 and 42 depict another example of this where a distal tip of an outer shaft of the delivery apparatus comprises mating feature configured to couple to a proximal end of the prosthetic valve and hold it rotationally in place.

[0169] In some examples, the balloons described herein can be shaped using a two-stage process. Prior to shaping the balloon, the balloon can be formed by blow molding a cylindrical parison. The two-stage shaping process can include a first stage of “pleating” the balloon which can involve shaping the blow molded balloon to have pleats with an intermediate geometry that resemble, but are radially expanded compared to, the final, compressed and folded shape of the balloon. Examples of dies used to perform the shaping in this first stage, as well as balloons in this intermediate geometry after being shaped by a die are shown in FIGS. 18A, 29, 30, 32, 33,,35-37, and 54. A second stage in this shaping process involves “folding” or compressing the pleats having the intermediate geometry radially inward into their final compressed and set shape, such as the balloons shown in FIGS. 18B, 31, 34, 55A-55C, 56, and 57.

[0170] In some examples, the pleat folding process can be performed with a folding tool, such as the folding tool depicted in FIGS. 58-61.

[0171] In some examples, a portion of the distal end portion of the delivery apparatus can comprise a protrusion that extends radially outwardly relative to a central longitudinal axis of the delivery apparatus, as shown in FIG. 43. As a prosthetic valve (or other prosthetic device) is moved axially over the protrusion and onto the balloon, it at least partially radially expands, thereby creating a space between the balloon and an inner surface of the prosthetic valve (as shown in FIG. 44). This space allows the balloon pleats to unfurl without causing the prosthetic valve to rotate.

[0172] In some examples, the inflatable balloon is a composite or multi-part balloon assembly comprising two or more balloons that are coupled together to form a central channel configured to receive a shaft of the delivery apparatus. For example, FIGS. 45A-48A depict a multi-part balloon assembly comprising two balloons which are coupled together to define a central channel for receiving an inner shaft of the delivery apparatus. FIGS. 48B-48D depict exemplary multi-part balloon assemblies with different numbers of balloons. Each balloon is individually pleated and folded into two or more pleats, as shown in the examples of FIGS. 49-53B.

[0173] By employing any one of or combination of the apparatuses or methods described above, zero (or essentially zero) rotation of the prosthetic valve during deployment, or between a pre -inflation state and post-inflation state, via balloon inflation with a delivery apparatus can be achieved. As a result, radiopaque markers included on the prosthetic valve can be used to implant the prosthetic valve in a desired rotational orientation relative to the native anatomy.Examples of the Disclosed Technology

[0174] FIG. 1 shows a prosthetic heart valve 100 (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.

[0175] 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 within a docking device implanted within or at the native mitral valve, such as disclosed in PCT Publication No. W02020 / 247907, which is incorporated herein by reference. 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 herein by reference.

[0176] The prosthetic heart valve 100 can include a stent or frame 102, a valvular structure 104, and a perivalvular outer sealing member or outer skirt 106. The prosthetic heart valve100 (and the frame 102) can have an inflow end 108 and an outflow end 110. The valvular structure 104 can be disposed on an interior of the frame 102 while the outer skirt 106 is disposed around an outer surface of the frame 102.

[0177] The valvular structure 104 can comprise a plurality of leaflets 112 (for example, three leaflets, as shown in FIG. 1), collectively forming a leaflet structure, which can be arranged to collapse in a tricuspid arrangement (or bicuspid arrangement in some examples). The leaflets 112 can be secured to one another at their adjacent sides (for example, commissure tabs) to form commissures 114 of the valvular structure 104. For example, each leaflet 112 can comprise opposing commissure tabs 115 disposed on opposite sides of the leaflet 112 and a cusp edge portion extending between the opposing commissure tabs 115. The cusp edge portion of the leaflets 112 can have an undulating, curved scalloped shape, and can be secured (for example, by sutures) to an inner skirt 124 which is then secured to the frame 102 (such as with sutures 126).

[0178] In some examples, the cusp edge portion of the leaflets 112 can be secured directly to the frame 102 (for example, by sutures).

[0179] In some examples, the leaflets 112 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.

[0180] In some examples, each of the outer skirt 106 and the inner skirt 124 can be an annular skirt. In some instances, the outer skirt 106 and / or the inner skirt 124 can comprise one or more skirt portions that are connected together and / or individually connected to the frame 102. The skirts 106, 124 can comprise a fabric or polymeric material, such as ePTFE, PTFE, PET, TPU, UHMWPE, PEEK, PE, etc. In some instances, instead of having a relatively straight upper edge portion, as shown in FIG. 1, the outer skirt 106 can have an undulating upper edge portion that extends along and is secured to the angled struts 134. Examples of such outer skirts, as well as various other outer skirts, that can be used with the frame 102 can be found in U. S. provisional patent application No. 63 / 366,599 filed June 17, 2022, which is incorporated by reference herein.

[0181] The frame 102 can be radially compressible and expandable between a radially compressed (or collapsed) configuration and a radially expanded configuration (the expanded configuration is shown in FIG. 1).

[0182] The frame 102 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 102 (and thus the valve 100) can be crimped to a radially compressed state on a delivery catheter and then expanded inside a patient by an inflatable balloon or equivalent expansion mechanism. When constructed of a self-expandable material, the frame 102 (and thus the valve 100) can be crimped to a radially compressed state and restrained in the compressed state by insertion into a sheath or equivalent mechanism of a delivery catheter. Once inside the body, the valve can be advanced from the delivery sheath, which allows the valve to expand to its functional size.

[0183] Suitable plastically-expandable materials that can be used to form the frames disclosed herein (for example, the frame 102) 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 102 can comprise stainless steel. In some examples, the frame 102 can comprise cobalt-chromium. In some examples, the frame 102 can comprise nickel -cobaltchromium. In some examples, the frame 102 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.

[0184] As shown in FIG. 1, the frame 102 can comprise a plurality of interconnected struts 116 which form multiple rows of open cells 118 between the outflow end 110 and the inflow end 108 of the frame 102. In some examples, the frame 102 can comprise three rows of cells 118 with a first (upper in the orientation shown in FIG. 1) row of cells 120 disposed at the outflow end 110. The first row of cells 120 comprises cells 118 that are elongated in an axial direction (relative to a central longitudinal axis 122 of the frame 102), as compared to cells 118 in the remaining rows of cells. For example, the cells 118 of the first row of cells 120 can have a longer axial length than cells 118 in the remaining rows of cells.

[0185] In some examples, as shown in FIG. 1, each row of cells comprises nine cells 118. Thus, in such examples, the frame 102 can be referred to as a nine-cell frame.

[0186] In alternate examples, the frame 102 can comprise more than three rows of cells (for example, four or five) and / or more or less than nine cells per row. In some examples, thecells 118 in the first row of cells 120 may not be elongated compared to cells 118 in the remaining rows of cells of the frame 102.

[0187] The interconnected struts 116 can include a plurality of angled struts 130 arranged in a plurality of rows of circumferentially extending rows of angled struts, with the rows being arrayed along the length of the frame 102 between the outflow end 110 and the inflow end 108. The interconnected struts 116 can also include a plurality of axially extending window struts 138 (or window strut portions) and a plurality of axial (or axially extending) struts 140. The axially extending window struts 138 (which can also be referred to as axial struts that include a commissure window) define commissure windows (for example, open windows) 142 that are spaced apart from one another around the frame 102, in a circumferential direction, and which are adapted to receive a pair of commissure tabs of a pair of adjacent leaflets 112 arranged into a commissure (for example, commissure 114). In some examples, the commissure windows 142 and / or the axially extending window struts 138 defining the commissure windows 142 can be referred to herein as commissure features or commissure supports, each commissure feature or support configured to receive and / or be secured to a pair of commissure tabs of a pair of adjacent leaflets.

[0188] One or more (for example, two, as shown in FIG. 1) axial struts 140 can be positioned between, in the circumferential direction, two commissure windows 142 formed by the window struts 138. Since the frame 102 can include fewer cells per row (for example, nine) and fewer axial struts 140 between each commissure window 142, as compared to some more traditional prosthetic heart valves, each cell 118 can have an increased width (in the circumferential direction), thereby providing a larger opening for blood flow and / or coronary access.

[0189] Each axial strut 140 and each window strut 138 forms an axial side of two adjacent cells of the first row of cells 120.

[0190] Commissure tabs 115 of adjacent leaflets 112 can be secured together to form commissures 114 (FIG. 1). Each commissure 114 of the prosthetic heart valve 100 comprises two commissure tabs 115 paired together, one from each of two adjacent leaflets 112, and extending through a commissure window 142 of the frame 102. Each commissure 114 can be secured to the window struts 138 forming the commissure window 142.

[0191] The prosthetic heart valve can comprise one or more radiopaque markers 170. As shown in the example of FIG. 1, a radiopaque marker 170 is coupled to one or more of the commissures 114.

[0192] Each radiopaque marker 170 can be configured to be at least partially opaque or otherwise visible under fluoroscopy and / or any other medical imaging technique (for example, computed tomography (CT) scanning, magnetic resonance imaging (MRI), plain radiography, ultrasound imaging, etc.). Additionally, each radiopaque marker 170 can be fixedly attached to a portion of the prosthetic heart valve (such as a commissure 114, as shown in FIG. 1). In this way, the radiopaque marker 170 can beneficially help a user (for example, a user of a delivery apparatus, such as delivery apparatus 200) determine a position or orientation of the prosthetic heart valve relative to a subject’s native anatomy, a guidewire extending through the delivery apparatus, a prosthetic medical device (for example, a docking device, a previously-implanted prosthetic heart valve, etc.), and / or any other feature during a prosthetic heart valve implantation procedure.

[0193] For example, each radiopaque marker 170 can be fixedly attached to any combination of a frame (for example, the frame 102), a commissure 114, a flexible connector (for example, flexible connector 172), a portion of a leaflet (for example, one of the commissure tabs 115 of a leaflet 112), a skirt (for example, inner skirt 124, outer skirt 106, etc.), and / or any other portion of the prosthetic heart valve. As the user rotates the prosthetic heart valve in a circumferential direction (about an axis extending between a proximal end and a distal end of the delivery apparatus and / or prosthetic heart valve, such as central longitudinal axis 122), the radiopaque marker 170 can rotate in unison with the rest of the prosthetic heart valve and provide the user with a target that is visible under fluoroscopy. The user can then determine, based on the visualized circumferential position or orientation of the radiopaque marker 170, a circumferential position or orientation of the prosthetic heart valve. In this example, since the radiopaque marker 170 is directly attached to a portion prosthetic heart valve instead of the delivery apparatus, the user does not need to mount the prosthetic heart valve onto the delivery apparatus in a specific, predetermined orientation prior to implantation, thereby simplifying the device prep and implantation procedure. Moreover, once implanted, the radiopaque marker 170 can serve as landmark on a host valve for positioning a guest valve at a specified orientation with respect to the host valve. For example, if one or more radiopaque markers 170 are positioned at one or more of the commissures of a host valve, the commissures of the guestvalve (also having one or more radiopaque markers 170), can be aligned with the commissures of the host valve in a valve-in-valve procedure.

[0194] As shown in FIG. 1, each radiopaque marker 170 is attached to a flexible connector 172 (which can be referred to as a “fabric connector”, since the flexible connector 172 can comprise a fabric in some examples). The flexible connector 172 can subsequently be coupled to the leaflets 112 (such as the commissure tabs 115 of the leaflets 112) and attached to the frame 102 in order to form the commissure 114. In other words, the radiopaque marker 170 can be attached to the commissure 114. In some examples, fixedly attaching the radiopaque marker 170 to the commissure 114 or adjacent the commissure 114 can help the user better determine the circumferential position or orientation of the commissures 114. Thus, in some examples, by helping the user determine the orientation of the prosthetic heart valve’s commissures 114, the radiopaque marker 170 can help the user better align the prosthetic heart valve’s commissures 114 to be circumferentially offset from the subject’s coronary arteries and / or the commissures of a host valve.

[0195] Each radiopaque marker 170 can have a different opacity under fluoroscopy than another portion of the prosthetic heart valve 100. For example, each radiopaque marker 170 can be opaquer than the rest of the prosthetic heart valve 100 (including the frame 102) when visualized under fluoroscopy in order to provide the user with a more visible target that is easier to identify and / or track during the implantation procedure.

[0196] Each radiopaque marker 170 can be formed from any radiopaque material. In some examples, each radiopaque marker 170 can be formed from a radiopaque metal, including but not limited to tantalum, gold, and / or platinum iridium. In some examples, the radiopacity of the radiopaque material (and thus the marker 170) can be greater than the radiopacity of any one of the other materials used to form the prosthetic heart valve (for the example, the materials forming any one of the frame 102, the valvular structure 104, the inner skirt 124, the outer skirt 106, etc.) to provide a more visible target under fluoroscopy.

[0197] It should be understood that although the opacity of the radiopaque markers 170 is primarily discussed herein with respect to fluoroscopy, it should be understood that the radiopaque markers 170 can additionally or alternatively be configured to be more opaque and / or visible under any medical imaging method used in a medical procedure (for example, computed tomography (CT) scanning, magnetic resonance imaging (MRI), plain radiography, ultrasound imaging, etc.).

[0198] In some examples, the one or more radiopaque markers 170 can optionally be asymmetric (reflection asymmetric) about a central longitudinal axis 174 of the radiopaque marker 170. The central longitudinal axis 174 can be parallel to the central longitudinal axis 122 of the prosthetic heart valve 100. For example, as shown in FIG. 1, each radiopaque marker 170 can have an asymmetric E-shape. The central longitudinal axis 174 can bisect the radiopaque marker 170 such that a first circumferential portion of the E-shape on a first side of the central longitudinal axis 174 and a second circumferential portion of the E-shape on a second, other side of the central longitudinal axis 174 have different shapes. The asymmetry of the radiopaque marker 170 can further help the user determine the relative circumferential orientation or position of the radiopaque marker 170. For example, the E-shape can face forwards (“E”) when the radiopaque marker 170 is facing in a circumferential direction that is relatively closer to a fluoroscopy screen than an X-ray source (“in the front plane of the fluoroscope image”) and can face backwards (“3”) when the radiopaque marker 170 is facing in a circumferential direction that is relatively farther away from the fluoroscopy screen and closer to the X-ray source (“in the back plane of the fluoroscope image”). Thus, the user can more easily determine, based on the direction of the visualization of the E-shape, whether the radiopaque marker 170 is in the front plane or back plane of the fluoroscope image. Although the asymmetric radiopaque marker 170 is shown as having the E-shape, the asymmetric radiopaque marker 170 can have a C-shape, an arrow shape, or any other shape that is asymmetric about the central longitudinal axis 174.

[0199] The flexible connector 172 can have various shapes and can be configured to be attached to the radiopaque marker 170 and wrap around commissure tabs 115 of the commissure 114. In some examples, the flexible connector 172 includes a flap that is folded over the radiopaque marker 170, as depicted in FIG. 1 by the dashed lines of the radiopaque marker 170 which indicate the positioning of the radiopaque marker 170 “behind” or “underneath” the flap of the flexible connector 172. This positioning can beneficially minimize contact between the radiopaque marker 170 and the subject’s native anatomy and / or a previously implanted prosthetic medical device. However, in some examples, it is possible for the radiopaque marker 170 to be attached over and radially outward facing (uncovered) on the flexible connector 172.

[0200] In some examples, the commissure 114 of the prosthetic heart valve 100 can be assembled and mounted to the respective commissure window 142 using the flexible connector 17 (such as with sutures).

[0201] Although FIG. 1 illustrate the radiopaque marker 170 being used in conjunction with the flexible connector 172, it should be understood that the radiopaque marker 170 can be implemented without the flexible connector 172. For example, the marker 170 can be fixedly attached (such as with sutures) to the leaflet material of the commissure 114 outside of the frame 102, such as by attaching the radiopaque marker 170 directly to the pair of commissure tabs 115.

[0202] The cusp edge portion (for example, scallop edge) of each leaflet 112 can be secured to the frame 102 via one or more fasteners (for example, sutures). In some examples, the cusp edge portion of each leaflet 112 can be secured directly to the struts of the frame 102.

[0203] In some examples, the cusp edge portion of the leaflets 112 can be secured to an inner skirt and the inner skirt can then be secured directly to the frame 102.

[0204] Various methods for securing the leaflets 112 to a frame, such as the frame 102, are disclosed in U. S. provisional patent applications 63 / 278,922, filed November 12, 2021, and 63 / 300,302, filed January 18, 2022, both of which are incorporated by reference herein.

[0205] The frame 102 can further comprise a plurality of apex regions 152 formed at the inflow end 108 and the outflow end 110, each apex region 152 extending and forming a junction between two angled struts 130 at the inflow end 108 or outflow end 110. As such, the apex regions 152 are spaced apart from one another, in a circumferential direction at the inflow end 108 and the outflow end 110. Additional details and examples of frames for prosthetic heart valves that include apex regions can be found in PCT Application No.PCT / US2022 / 025687, which is incorporated by reference herein.

[0206] FIGS. 2-5B show a delivery apparatus 200, according to an example, that can be used to implant an expandable prosthetic heart valve (for example, the prosthetic heart valve 100 of FIG. 1). In some examples, the delivery apparatus 200 is specifically adapted for use in introducing a prosthetic valve into a heart.

[0207] The delivery apparatus 200 generally includes a steerable guide catheter 214, and a balloon catheter 216 extending through the guide catheter 214. The guide catheter 214 an also be referred to as a flex catheter or a main catheter. The use of the term “main catheter”should be understood, however, to include flex or guide catheters, as well as other catheters or shafts that do not have the ability to flex or guide through a patient’s vasculature.

[0208] The guide catheter 214 and the balloon catheter 216 in the illustrated example are adapted to slide longitudinally relative to each other to facilitate delivery and positioning of a prosthetic valve 212 (which may be the prosthetic valve 100 of FIG. 1, in some examples) at an implantation site in a patient' s body, as described further below.

[0209] The guide catheter 214 includes a handle portion 220 (as shown in FIGS. 2-3B) and an elongated guide tube, or shaft, 222 extending from handle portion 220 (FIG. 3A, 4, and 5A). FIG. 2 shows the delivery apparatus without the guide catheter shaft 222 for purposes of illustration. FIG. 4 shows the guide catheter shaft 222 extending from the handle portion 220 over the balloon catheter. The balloon catheter 216 includes a proximal portion 224 (FIG. 2) adjacent the handle portion 220 and an elongated shaft 226 (referred to herein as the balloon catheter shaft or balloon shaft) that extends from the proximal portion 224 and through handle portion 220 and guide catheter shaft 222 (FIGS. 2, 4, and 5A).

[0210] The handle portion 220 can include a side arm 227 having an internal passage which fluidly communicates with a lumen defined by the handle portion 220.

[0211] An inflatable balloon 228 is mounted at the distal end of balloon catheter 216. As shown in FIG. 5A, the delivery apparatus 200 is configured to mount the prosthetic valve 212 in a crimped (radially compressed) state proximal to the balloon 228 for insertion of the delivery apparatus 200 and prosthetic valve 212 into a patient’s vasculature, which is described in detail in U. S. Publication No. 2009 / 0281619, which is incorporated by reference herein. Because the prosthetic valve 212 is crimped at a location different from the location of balloon 228 (for example, in this case the prosthetic valve 212 is crimped proximal to balloon 228), the prosthetic valve 212 can be crimped to a lower profile than would be possible if prosthetic valve 212 was crimped on top of the balloon 228. This lower profile permits the user to more easily navigate the delivery apparatus (including crimped valve 212) through a patient’s vasculature to the treatment location. The lower profile of the crimped prosthetic valve is particularly helpful when navigating through portions of the patient’s vasculature which are particularly narrow, such as the iliac artery. The lower profile also allows for treatment of a wider population of patients.

[0212] The inflatable balloon 228 can be formed from any of various polymers traditionally used for forming medical balloons (e.g., nylon, Pebax, PET, etc.).

[0213] In some examples, the inflatable balloon 228 can be formed from woven filaments (fibers) with polymeric sealing layers.

[0214] The inflatable balloon 228 can be uniform in diameter along its length, or it can be tapered at one or both ends (e.g., the balloon 228 can comprise cones or conical end portions).

[0215] A nose cone 232 (FIG.5A) (or nose cone) can be mounted at the distal end of the delivery apparatus 200 to facilitate advancement of the delivery apparatus 200 through the patient’s vasculature to the implantation site. In some instances, it may be useful to have nose cone 232 connected to a separate elongated shaft so that nose cone 232 can move independently of other elements of delivery apparatus 200.

[0216] As can be seen in FIG. 3 A, the balloon catheter 216 can include an inner shaft 234 that extends from the proximal portion 224 and coaxially through the outer balloon catheter shaft 226 (which can also be referred to as an “outer shaft”) and the balloon 228. In some examples, the nose cone 232 can be mounted on a distal end portion of the inner shaft 234.

[0217] In some examples, the nose cone 232 includes or is coupled to a distal shoulder 233 (which may be a polymeric body), which in turn is mounted on the distal end portion of the inner shaft 234, as shown in FIG. 5B.

[0218] In some examples, a mounting member 235 can be arranged around the inner shaft 234, within the balloon 228, to help secure a prosthetic valve on the balloon 228 once positioned there, as described herein (as shown in FIG. 5B).

[0219] The outer balloon catheter shaft 226 can be referred to as a “balloon shaft” or “balloon catheter shaft”. The balloon 228 can be supported on a distal end portion of inner shaft 234 that extends outwardly from and distal to the outer shaft 226, with a proximal end portion 236 of the balloon 228 secured to the distal end of the outer shaft 226 (FIG. 2). The outer diameter of inner shaft 234 is sized such that an annular space is defined between the inner shaft 234 and the outer shaft 226 along the entire length of the outer shaft 226. The proximal portion 224 of the balloon catheter can be formed with a fluid passageway (not shown) that is fluidly connectable to a fluid source (e.g., saline) for inflating the balloon. The fluid passageway is in fluid communication with the annular space between inner shaft 234 and outer shaft 226 such that fluid from the fluid source can flow through fluid passageway, through the space between the shafts, and into balloon 228 to inflate the same and deploy prosthetic valve 212.

[0220] The proximal portion 224 also defines an inner lumen that is in communication with a lumen 238 of the inner shaft 234 that is sized to receive guide wire (not shown) that can extend coaxially through the inner shaft 234 and the nose cone 232.

[0221] The inner shaft 234 and balloon catheter shaft 226 (or outer shaft) of the balloon catheter can be formed from any of various suitable materials, such as nylon, braided stainless steel wires, or a polyether block amide (commercially available as Pebax®). The shafts 226, 234 can have longitudinal sections formed from different materials in order to vary the flexibility of the shafts along their lengths. The inner shaft 234 can have an inner liner or layer formed of Teflon® to minimize sliding friction with a guide wire.

[0222] The distal end portion of the guide catheter shaft 222 comprises a steerable section 268 (FIG. 4), the curvature of which can be adjusted by the operator to assist in guiding the apparatus through the patient’s vasculature, and particularly the aortic arch. The handle portion 220 (or handle 220) in the illustrated example comprises a distal handle portion 246 and a proximal handle portion 248. The distal handle portion 246 functions as a mechanism for adjusting the curvature of the distal end portion of the guide catheter shaft 222 and, in some examples, as a flex indicating device that allows a user to measure the relative amount of flex of the distal end of the guide catheter shaft 222. In some examples, the flex indicating device can provide a visual and tactile response at the handle the device, which provides a user with an immediate and direct way to determine the amount of flex of the distal end of the catheter.

[0223] The distal handle portion 246 can be operatively connected to the steerable section 268 and functions as an adjustment mechanism to permit operator adjustment of the curvature of the steerable section via manual adjustment of the handle portion. In some examples, the handle portion 246 can comprise a flex activating member 250, an indicator pin 252, and a cylindrical main body, or housing 254. As shown in FIGS. 3A and 3B, the flex activating member 250 comprises an adjustment knob 256 and a shaft 258 extending proximally from the knob into the housing 254. A proximal end portion of the guide catheter shaft 222 extends into and is fixed within the central lumen of the housing 254. An inner sleeve 270 surrounds a portion of the guide catheter shaft 222 inside the housing 254. A threaded slide nut 272 is disposed on and is slidable relative to the sleeve 270. The slide nut 272 is formed with external threads that mate with internal threads 260 of the shaft 258.

[0224] The slide nut 272 can be formed with two slots formed on the inner surface of the nut and extending the length thereof. The sleeve 270 can be formed with longitudinally extending slots that are aligned with the slots of the slide nut 272 when the slide nut is placed on the sleeve. Disposed in each slot is a respective elongated nut guide, which can be in the form of an elongated rod or pin 276. The pins 276 extend radially into respective slots in the slide nut 272 to prevent rotation of the slide nut 272 relative to the sleeve 270. By virtue of this arrangement, rotation of the adjustment knob 256 (either clockwise or counterclockwise) causes the slide nut 272 to move longitudinally relative to the sleeve 270 in the directions indicated by double -headed arrow 274 (FIG. 3B).

[0225] One or more pull wires 278 (FIG. 3A) couple the adjustment knob 256 to the steerable section 268 to adjust the curvature of the steerable section upon rotation of the adjustment knob. For example, the proximal end portion of the pull wire 278 can extend into and can be secured to a retaining pin, such as by crimping the pin around the proximal end of the pull wire, which pin is disposed in a slot in the slide nut 272. The pull wire can extend from the pin, through the slot in the slide nut, a slot in the sleeve 270, and into and through a pull wire lumen in the shaft 222. The distal end portion of the pull wire is secured to the distal end portion of the steerable section 268.

[0226] In some examples, the pin, which retains the proximal end of the pull wire 278, is captured in the slot in the slide nut 272. Hence, when the adjustment knob 256 is rotated to move the slide nut 272 in the proximal direction, the pull wire also is moved in the proximal direction. The pull wire pulls the distal end of the steerable section 268 back toward the handle portion, thereby bending the steerable section and reducing its radius of curvature. The friction between the adjustment knob 256 and the slide nut 272 is sufficient to hold the pull wire taut, thus preserving the shape of the bend in the steerable section if the operator releases the adjustment knob 256. When the adjustment knob 256 is rotated in the opposite direction to move the slide nut 272 in the distal direction, tension in the pull wire is released. The resiliency of the steerable section 268 causes the steerable to return its normal, nondeflected shape as tension on the pull wire is decreased. Because the pull wire is not fixedly secured to the slide nut 272 (the pin can move within the slot in the nut), movement of the slide nut in the distal direction does not push on the end of the pull wire, causing it to buckle. Instead, the pin is allowed to float within the slot of the slide nut 272 when the knob 256 is adjusted to reduce tension in the pull wire, preventing buckling of the pull wire.

[0227] In some examples, the steerable section 268 in its non-deflected shape is slightly curved and in its fully curved position, the steerable section generally conforms to the shape of the aortic arch. In other embodiments, the steerable section can be substantially straight in its non-deflected position.

[0228] The distal handle portion 246 can have other configurations that are adapted to adjust the curvature of the steerable section 268. One such alternative handle configuration is shown in U. S. Publication No. 2007 / 0005131, which is incorporated by reference herein in its entirety. Additional details relating to the steerable section and handle configuration discussed above can be found in U. S. Patent Publication No. US2008 / 0065011 and US2013 / 0030519, which are incorporated by reference herein in their entireties.

[0229] The shaft 258 can also include an externally threaded surface portion 262. As shown in FIG. 3B, a base portion 264 of the indicator pin 252 mates with the externally threaded surface portion 262 of the shaft 258. The shaft 258 extends into the housing 254 and the indicator pin 252 is trapped between the externally threaded surface portion 262 and the housing 254, with a portion of the indicator pin 252 extending into a longitudinal slot 266 of the handle. As the knob 256 rotated to increase the curvature of the distal end of the guide catheter shaft 222, the indicator pin 252 tracks the external threaded portion 262 of the flex activating member and moves in the proximal direction inside of the slot 266. The greater the amount of rotation of the knob 256, the further indicator pin 252 moves towards the proximal end of the proximal handle portion 246. Conversely, rotating the knob 256 in the opposite direction decreases the curvature of the distal end of the guide catheter shaft 222 (z. e., straightens the guide catheter shaft) and causes corresponding movement of the indicator pin 252 toward the distal end of the distal handle portion 246.

[0230] The outer surface of the housing 254 of the distal handle portion 246 can include visual indicia adjacent the slot 266 that indicate the amount of flex of the distal end of the guide catheter shaft 222, based on the position of the indicator pin 252 relative to the visual indicia. Such indicia can identify the amount of flex in any of a variety of manners. For example, the outer surface of the housing 254 can include a series of numbers (for example, 0 to 10) adjacent the slot that indicate the amount of curvature of the guide catheter shaft 222 based on the position of the indicator pin 252 relative to the number scale.

[0231] As described above, when the delivery apparatus is introduced into the vasculature of the patient, a crimped (or radially compressed) prosthetic valve 212 is positioned proximal tothe balloon 228 (FIG. 5A). In some examples, as shown in FIG. 5B, the delivery apparatus 200 includes a relatively thin piece of tubing or a sleeve, which can be referred to herein as a crimp balloon 225, that couples a distal end of the balloon catheter shaft 226 to a proximal end (which may include and be referred to as a proximal leg 231) of the inflatable balloon 228. The crimp balloon 225 can be made of any of various polymers traditionally used for forming medical balloons (e.g., nylon, Pebax, etc.). The prosthetic valve can be radially compressed around the crimp balloon 225 for delivery through the patient’s vasculature. In some examples, the crimp balloon 225 and the balloon 228 are made of the same material. In some examples, the crimp balloon 225 can be at least partially inflated with an inflation fluid to partially expand a prosthetic valve mounted thereon prior to repositioning the prosthetic valve onto the balloon 228, as further described below.

[0232] Prior to expansion of the balloon 228 and deployment of prosthetic valve 212 at the treatment site, the prosthetic valve 212 is moved axially relative to the balloon (or vice versa) to position the crimped prosthetic valve on the balloon 228 for deploying (expanding) the prosthetic valve. For example, as discussed below, the proximal handle portion 248 can serve as an adjustment device that can be used to move the balloon 228 proximally into position within the frame of prosthetic valve 212, and further to accurately position the balloon and the prosthetic valve at the desired deployment location.

[0233] As shown in FIGS. 3 A and 3B, the proximal handle portion 248 comprises an outer housing 280 and an adjustment mechanism 282. The adjustment mechanism 282, which is configured to adjust the axial position of the balloon catheter shaft 226 relative to the guide catheter shaft 222, comprises an adjustment knob 284 and a shaft 286 extending distally into the housing 280. Mounted within the housing 280 on the balloon catheter shaft 226 is an inner support 288, which in turn mounts an inner shaft 290 (also referred to as a slider or sliding mechanism). The inner shaft 290 has a distal end portion 292 formed with external threads that mate with internal threads 294 that extend along the inner surface of the adjustment mechanism 282. The inner shaft 290 further includes a proximal end portion 296 that mounts a securement mechanism 298, which is configured to retain the position of the balloon catheter shaft 226 relative to the proximal handle portion 248 for use of the adjustment mechanism 282, as further described below. The inner shaft 290 can be coupled to the inner support 288 such that rotation of shaft 286 causes the inner shaft 290 to move axially within the handle. For example, the inner support 288 can have an axially extendingrod or rail that extends into slot formed in the inner surface of the inner shaft 290. The rod or rail prevents rotation of the inner shaft 290 but allows it to move axially upon rotation of the shaft 286.

[0234] The securement mechanism 298 includes internal threads that mate with external threads of the proximal end portion 296 of the inner shaft. Mounted within the proximal end portion 296 on the balloon catheter shaft 226 is a pusher element 210 and a shaft engagement member in the form of a collet 202. The collet 202 is configured to be manipulated by the securement mechanism between a first state in which collet allows the balloon catheter shaft to be moved freely in the longitudinal and rotational directions and a second state in which the collet frictionally engages the balloon catheter shaft and prevents rotational and longitudinal movement of the balloon catheter shaft relative to the inner shaft 290.

[0235] As noted above, the securement mechanism 298 is operable to restrain movement of the balloon catheter shaft 226 (in the axial and rotational directions) relative to the proximal handle portion 248. In some examples, the securement mechanism 298 is movable between a proximal position (shown in FIGS. 3A and 3B) and a distal position closer to the adjacent end of the knob 284. In the proximal position, the collet 202 applies little, if any, force against the balloon catheter shaft 226, which can slide freely relative to the collet 202, the entire handle portion 220, and the guide catheter shaft 222. When the securement mechanism 298 is rotated so as to move to its distal position closer to knob 284, the securement mechanism urges pusher element 210 against the proximal end of the collet 202. The holding force of the collet 202 against the balloon catheter shaft 226 locks the balloon catheter shaft 226 relative to the inner shaft 290. In the locked position, rotation of the adjustment knob 284 causes the inner shaft 290, the inner shaft 234, and the balloon catheter shaft 226 to move axially relative to the guide catheter shaft 222 (either in the proximal or distal direction, depending on the direction the knob 284 is rotated).

[0236] The adjustment knob 284 can be utilized to position the prosthetic valve 212 on the balloon 228 and / or once the prosthetic valve 212 is on the balloon 228, to position the prosthetic valve and the balloon at the desired deployment site within the native valve annulus.

[0237] One exemplary method for implanting the prosthetic valve 212 (which may be the prosthetic valve 100, in some examples) in the native aortic valve is as follows. The prosthetic valve 212 initially can be crimped on a mounting region (FIG. 5A) of the deliveryapparatus immediately adjacent the proximal end of the balloon 228 (such as on a crimp balloon and / or on the balloon catheter shaft 226). The proximal end of the prosthetic valve can abut the distal end 223 of the guide catheter shaft 222 (FIG. 5A), which keeps the prosthetic valve in place on the balloon catheter shaft or crimp balloon as the delivery apparatus and prosthetic valve are inserted through an introducer sheath. The prosthetic valve 212 can be delivered in a transfemoral procedure by first inserting an introducer sheath into the femoral artery and pushing the delivery apparatus through the introducer sheath into the patient’s vasculature.

[0238] After the prosthetic valve 212 is advanced through the narrowest portions of the patient’s vasculature (e.g., the iliac artery), the prosthetic valve 212 can be moved onto the balloon 228. For example, a convenient location for moving the prosthetic valve onto the balloon is the descending aorta or the ascending aorta. The prosthetic valve can be moved onto the balloon, for example, by holding the handle portion 246 steady (which retains the guide catheter shaft 222 in place) and moving the balloon catheter shaft 226 and the inner shaft 234 in the proximal direction relative to the guide catheter shaft 222. As the balloon catheter shaft and the inner shaft are moved in the proximal direction, the distal end 223 of the guide catheter shaft pushes against the prosthetic valve, allowing the balloon 228 to be moved proximally through the prosthetic valve in order to center the prosthetic valve on the balloon 228. The balloon catheter shaft can include one or more radiopaque markers to assist the user in positioning the prosthetic valve at the desired location on the balloon. The balloon catheter shaft 226 can be moved in the proximal direction by simply sliding / pulling the balloon catheter shaft in the proximal direction if the securement mechanism 298 is not engaged to retain the shaft 226. For more precise control of the shaft 226, the securement mechanism 298 can be engaged to retain the shaft 226, in which case the adjustment knob 284 is rotated to effect movement of the shaft 226 and the balloon 228. The axial position of the balloon shaft 226 can be fixed relative to the inner shaft 234, such that axial movement of the balloon shaft 226 relative to the outer shaft 222 produces axial movement of the balloon shaft 226, the inner shaft 234, and the balloon 228 relative to the outer shaft 222. In lieu of or in addition to moving the balloon shaft 226, the inner shaft 234, and the balloon 228 proximally relative to the outer shaft 222, repositioning of the prosthetic valve can be accomplished by moving the outer shaft 222 distally relative to the balloon shaft 226, the inner shaft 234, and the balloon 228.

[0239] After repositioning the prosthetic valve 212, the delivery apparatus 200 can be advanced to position the prosthetic valve 212 near the intended implantation site. For example, when implanting the prosthetic valve 212 within the native aortic valve, the prosthetic valve can be positioned within the ascending aorta downstream the native aortic valve. At this time, the delivery apparatus 200 can be rotated to produce rotation of the prosthetic valve 212 and achieve rotational alignment of the prosthetic valve with a location or landmark of the native anatomy. Rotation of the prosthetic valve can be accomplished by locking or fixing the balloon shaft (e.g., shaft 226) and the inner shaft 234 against rotation relative to the handle portion (such as by actuating securement mechanism 298) and the rotating the handle portion 220, which in turn rotates the balloon shaft 226, the inner shaft 234, the balloon 228, and the prosthetic valve. Alternatively, the prosthetic valve can be rotated by gripping and rotating a proximal end portion of the balloon shaft 226 or proximal portion 224, which is effective to rotate the balloon shaft 226, the inner shaft 234, the balloon 228, and the prosthetic valve. In some examples, as introduced above, radiopaque markers coupled to commissures of the prosthetic valve (such as markers 170 of valve 100 in FIG. 1) can be used to rotationally align the prosthetic valve on the delivery apparatus relative to the native anatomy. Various imaging techniques can be used to rotationally align the prosthetic valve with respect to the native annulus. Further details of methods and devices for rotationally aligning a prosthetic valve with respect to the native annulus are disclosed in PCT Patent Publication Nos. WO 2022 / 046585 and WO 2024 / 015267, which are incorporated by reference herein in their entireties.

[0240] Further details on the delivery apparatus 200 can be found in U. S. Patent No.9,339,384, which is incorporated by reference herein in its entirety.

[0241] As introduced above, it may be desirable to deploy the prosthetic valve in a specified circumferential orientation relative to the native anatomy, such as commissures of the prosthetic valve being rotationally aligned with commissures of the native valve. In some examples, radiopaque markers that are visible under medical imaging can be attached to one or more commissures of the prosthetic valve (for example, markers 170 shown in FIG. 1). However, because the folding or pleating of the inflatable balloon (for example, balloon 228) on the delivery apparatus, in a deflated state, can cause rotation of the prosthetic valve during inflation of the balloon and radial expansion of the prosthetic valve, rotationally aligning theprosthetic valve using the valve commissure markers can result in inaccurate positioning of the implanted prosthetic valve at the native valve.

[0242] For example, FIG. 6 is a schematic cross-sectional view of the inflatable balloon 228 arranged around the inner shaft 234. The inflatable balloon 228 comprises a plurality of pleats 230 (or folds) that are pleated in a unidirectional spiral or curve around the inner shaft 234. It should be noted that while FIG. 6 depicts spaces between adjacent pleats 230, when arranged on a delivery apparatus (such as delivery apparatus 200) in a compressed and deflated configuration, the pleats 230 can be tightly folded against one another, spiraling around the inner shaft 234 in a first direction 237 (for example, clockwise as shown in FIG.6). Tight pleating in this manner can reduce a diameter of the balloon 228 in the deflated state, thereby reducing push forces of the delivery apparatus when navigating through a patient’s vasculature.

[0243] As used herein a “compressed and deflated” configuration or state of a balloon can refer to its state after formation and / or when mounted around a shaft of a delivery apparatus prior to inflation. In this state, the pleats of the balloon can be folded or compressed radially inward toward or against a central cavity of the balloon that surrounds the shaft of the delivery apparatus. The balloon can be in the compressed and deflated configuration while the delivery apparatus navigates through a patient’s vasculature toward an implantation site. After reaching an implantation site, the balloon can be inflated to its inflated configuration or state, where its pleats unfurl or unfold such that the balloon can expand radially outward and radially expand a prosthetic device mounted thereon.

[0244] When a prosthetic valve is mounted around the pleated inflatable balloon 228, the prosthetic valve can be radially expanded and deployed by inflating the inflatable balloon 228 (for example, by filling an interior of the balloon 228 with inflation fluid). As the balloon 228 is inflated, the pleats 230 unfurl (or unwind) and rotate in a second direction 239 that is opposite the pleating direction 237. As a result, the prosthetic valve rotates in the second direction 239 as it radially expands. This can cause the prosthetic valve to be implanted in a circumferential position that is offset from the desired circumferential position relative to the native anatomy, thereby incorrectly positioning the prosthetic valve relative to the native anatomy.

[0245] In some examples, radiopaque markers can be included on the delivery apparatus. Because the folding of the inflatable balloon on the delivery apparatus can cause rotation ofthe prosthetic valve during radial expansion, as explained above with reference to FIG. 6, specific accessories and processes can be used to account for this rotation and rotationally align the prosthetic valve on the delivery apparatus relative to the radiopaque marker on the delivery apparatus.

[0246] Thus, it is desirable for the delivery apparatus to include an inflatable balloon that does not cause rotation of the prosthetic valve during radial expansion and deployment, or to include another component that decouples the rotational forces of the inflatable balloon from the prosthetic valve such that rotation of the balloon does not cause rotational of the prosthetic valve. For such delivery apparatuses, radiopaque markers on the prosthetic valve (such as on one or more commissures) can be used to rotationally align the prosthetic valve relative to the native anatomy, and the prosthetic valve can be implanted in the native anatomy in the desired rotational positioning. This eliminates the need to rotationally offset a commissure of the prosthetic valve from a radiopaque marker on the delivery apparatus to account for balloon unfurling and rotations. As a result, extra accessories and procedures for mounting the prosthetic valve on the delivery apparatus in a specified rotational orientation are not needed, thereby saving time and costs prior to and / or during an implantation procedure.

[0247] FIG. 28 depicts an exemplary method 900 for shaping an inflatable balloon and / or deploying a prosthetic device, such as a prosthetic valve or another prosthetic valve such as a stent, without rotating the prosthetic device during deployment of the device with a delivery apparatus that includes the inflatable balloon. As a result, the prosthetic valve can be accurately positioned relative to the native anatomy. Method 900 can be implemented with any one of or combination of the methods, balloons, or members described below with reference to FIGS. 7-27 and 28-37. Additionally, the method 900 described below can be performed with a variety of balloon-expandable prosthetic devices, such as a prosthetic valve or stent, and a variety of delivery apparatuses comprising a balloon.

[0248] Method 900 can begin at 902 by shaping a balloon into a compressed and deflated configuration and / or mounting the balloon in the compressed and deflated configuration around a shaft of a delivery apparatus for a radially expandable prosthetic device, wherein the shaped balloon comprises a central cavity surrounding the shaft and plurality of pleats extending outward from the central cavity.

[0249] In some examples, mounting the balloon around the shaft of the delivery apparatus includes bonding a proximal end portion (such as a proximal leg) of the balloon to a first component of the delivery apparatus (for example, crimp balloon 225, as shown in FIG. 5B) and bonding a distal end portion (such as the distal leg) of the balloon to a second component of the delivery apparatus (for example, a distal tip or nose cone of the delivery apparatus that is mounted to a distal end of the inner shaft 234, as shown in FIG. 5B).

[0250] In some examples, the balloon can be shaped, including the formation of pleats, prior to mounting the balloon on the delivery apparatus. In some examples, the balloon can be mounted on the delivery apparatus and one or more shaping steps, such as the formation of pleats and / or twisting the balloon (described below) can be performed subsequent to mounting the balloon.

[0251] In some examples, the method at 902 can include folding the plurality of pleats against one another such that they curve around the central cavity in a first circumferential direction.

[0252] In some examples, shaping the balloon into the compressed and deflated configuration at 902 includes twisting the balloon relative to a longitudinal axis of the balloon such that a distal leg of the balloon is twisted away (or circumferentially offset) from a proximal leg of the balloon in a second circumferential direction that is opposite the first circumferential direction (for example, as shown in FIG. 9B and FIGS. 10A-10C).

[0253] In some examples, shaping and twisting the balloon includes arranging a first sleeve around a proximal cone of the balloon and radially compressing the proximal cone, where the proximal cone is disposed between the proximal leg and the inflatable body. In some examples, the radially compressing includes applying heat and / or force to the first sleeve.

[0254] In some examples, shaping and twisting the balloon includes arranging a second sleeve around at least a portion of the pleated and folded inflatable body of the balloon and radially compressing the portion of the pleated and folded inflatable body. In some examples, the radially compressing includes applying heat and / or force to the second sleeve.

[0255] In some examples, the first and second sleeves are shrink tubes.

[0256] In some examples, shaping the balloon into the compressed and deflated configuration at 902 includes folding the plurality of pleats around the central cavity such that a first group of pleats curve around the central cavity in a first direction and a second group of pleats curve around the central cavity in an opposite, second direction (for example, as shown in FIG. 16).

[0257] In some examples, shaping the balloon into the compressed and deflated configuration at 902 includes shaping the plurality of pleats such that each pleat of the plurality of pleats has no directional bias in a circumferential direction (for example, as shown in FIGS. 22 A, 22B, and 24).

[0258] In some examples, shaping the balloon into the compressed and deflated configuration at 902 includes shaping the plurality of pleats such that the plurality of pleats is arranged into a plurality of circumferentially extending rows of angled pleats, wherein a first group of first rows of the plurality of rows comprise pleats angling in a first direction around the balloon, relative to a central longitudinal axis of the balloon, and a second group of second rows of the plurality of rows comprise pleats angling in a second direction around the balloon (for example, as shown in FIG. 23).

[0259] In some examples, shaping the balloon into the compressed and deflated configuration at 902 includes shaping and / or folding the plurality of pleats into T-shaped pleats that branch off the central cavity in a radial direction and are spaced apart around the central cavity (for example, as shown in FIG. 12).

[0260] In some examples, shaping the balloon into the compressed and deflated configuration at 902 includes shaping and / or folding the plurality of pleats into a plurality of stacked pleats that zigzag and fold over themselves in a radial direction (for example, as shown in FIGS. 13A, 13B, and FIG. 17).

[0261] In some examples, shaping the balloon into the compressed and deflated configuration at 902 includes shaping and / or folding the plurality of pleats into spiral pleats that are circumferentially spaced apart around the central cavity (for example, as shown in FIGS. 14A-15B).

[0262] In some examples, shaping the balloon into the compressed and deflated configuration at 902 can include shaping the balloon with a two-stage process that includes first “pleating” the balloon with a die to have pleats with an intermediate geometry (such as shown in FIGS.29, 30, 32, 33, 35, and / or 36, which are described further below) and then folding or compressing the pleats with the intermediate geometry radially inward into their final compressed and set shape (such as shown in FIGS. 13A, 14A, 15A, 17, 18B, 31, and 34, which are described further below).

[0263] The method 900 can include, at 904, mounting a prosthetic device (e.g., a prosthetic valve), in a radially collapsed configuration, around a distal end portion of the delivery apparatus, on or adjacent to the balloon.

[0264] For example, in some delivery apparatuses, the prosthetic device can be mounted directly on the balloon.

[0265] In some delivery apparatuses, such as the delivery apparatus 200 shown in FIGS. 5 A and 5B, the prosthetic device is initially mounted on the delivery apparatus, proximal to the inflatable balloon (for example, around the crimp balloon 225). Prior to balloon inflation, the prosthetic device is moved axially onto the inflatable balloon of the delivery apparatus.

[0266] In some examples, the prosthetic device is a prosthetic valve comprising a radiopaque marker at one or more commissures, such as the prosthetic valve 100 shown in FIG. 1.

[0267] In some examples, the prosthetic device can be mounted in any rotational position relative to the delivery apparatus (for example, the prosthetic device does not need to be rotationally mounted with respect to a marker or landmark on the delivery apparatus, and instead the prosthetic device can comprise one or more radiopaque markers for rotationally aligning the prosthetic device at the implantation site). Eliminating alignment of the prosthetic device on the delivery apparatus can greatly simplify the crimping procedure for the prosthetic device that is performed by the physician just prior to an implantation procedure.

[0268] In some examples, a polymeric sleeve is arranged around at least a portion of the balloon. Thus, in some examples, mounting the prosthetic device in the radially collapsed configuration on the distal end portion of the delivery apparatus at 904 includes mounting the prosthetic device around the polymeric sleeve such that the polymeric sleeve separates the prosthetic device from the balloon.

[0269] In some examples, the prosthetic device is mounted off the balloon initially and then moved axially onto the polymeric sleeve prior to balloon inflation.

[0270] In some examples, a lubricating coating can be applied over at least the portion of the balloon, and the polymeric sleeve can be arranged over the lubricating coating.

[0271] At 906, the method includes inflating the balloon to radially expand the prosthetic device without rotating the prosthetic device relative to the shaft of the delivery apparatus and implanting the prosthetic device at an implantation site in a specified rotational position relative to the implantation site.

[0272] In some examples, implanting the prosthetic device at an implantation site in a specified rotational position relative to the implantation site includes implanting the prosthetic device in a specified rotational position relative to the native anatomy at the implantation site (such as a native valve). For example, the specified rotational position can include implanting a prosthetic valve such that its commissures are circumferentially aligned with commissures of a native valve (which in some examples, can be a native aortic valve).

[0273] In some examples, implanting the prosthetic device at an implantation site in a specified rotational position relative to the implantation site includes implanting the prosthetic device in a specified rotational position relative to a previously implanted prosthetic valve at the implantation site (such as a surgical valve within a native valve). For example, the specified rotational position relative to the previously implanted valve can include implanting a prosthetic valve such that its commissure are circumferentially aligned with commissures of the previously implanted valve.

[0274] In some examples, the method at 906 can further include, prior to inflating the balloon, axially moving the prosthetic device onto the balloon (for example, when the prosthetic device is initially mounted on the delivery apparatus at a location proximal to the balloon).

[0275] In some examples, the method at 906 can further include, prior to inflating the balloon, rotating the balloon and prosthetic device mounted thereon into the specified rotational position relative to the native anatomy.

[0276] In some examples, inflating the balloon at 906 includes expanding each pleat of the plurality of pleats directly radially outward relative to a central longitudinal axis of the balloon.

[0277] In some examples, inflating the balloon at 906 includes maintaining a circumferential position of the balloon relative to the shaft as the balloon inflates (for example, pleats of the balloon do not curve or rotate in the circumferential direction as they unfurl and expand).

[0278] In some examples, the methods at 904 and / or 906 can include, prior to inflating the balloon, coupling one or more holding devices (or members, such as those shown in FIGS. 26 and 27) that are attached to the delivery apparatus to one or more ends of the prosthetic device. The one or more holding devices are configured to maintain a rotational position of the prosthetic device on the delivery apparatus during inflating the balloon and radially expanding the prosthetic device, even if the balloon rotates.

[0279] In some examples, the method 900 can be used to implant a prosthetic device, such as a prosthetic valve, in the native anatomy of a human subject.

[0280] In some examples, the method 900 is performed on a living animal or on a simulation.

[0281] Turning now to FIGS. 7-1 IB, examples of twisting the inflatable balloon for the delivery apparatus during the balloon manufacturing process are depicted. This balloon twist can counteract the rotation of the balloon due to its pleating (for example, the pleating direction), thereby preventing the prosthetic valve from rotating during inflation of the balloon.

[0282] FIG. 7 depicts an exemplary inflatable balloon 300, which in some examples can be used in lieu of the inflatable balloon 228 in the delivery apparatus 200. The balloon 300 comprises an inflatable main body portion 302 (which can be referred to as a “working length” of the balloon”), a proximal leg 304, and a distal leg 306. In some examples, as shown in FIG. 7, the balloon 300 comprises a proximal cone 303 extending between the proximal leg 304 and main body portion 302 (at an angle) and a distal cone 305 extending between the distal leg 306 and main body portion 302 (at an angle). The proximal cone 303 and distal cone 305 can have conical shapes and be referred to as tapering between the main body portion 302 and their respective balloon legs.

[0283] An inflatable balloon, such as the inflatable balloon 300, can be manufactured by forming and shaping the balloon. Typically, although not necessarily, the balloon is formed and then shaped in a subsequent, separate step. The balloon forming process can include blow molding a parison to form a balloon (as depicted in FIG. 7, for example). The balloon shaping process can include pleating and / or folding the balloon. In some examples, as explained further below with reference to FIGS. 8-1 IB, the balloon shaping process can also include compressing one or more portions of the balloon. Following the balloon shaping process, in some examples, the balloon is in a deflated and compressed state (or configuration), such as the states of the balloon 300 depicted in FIGS. 8-9C.

[0284] Prior to the balloon shaping process, the proximal leg 304 and distal leg 306 of the balloon 300 can be respectively marked with a proximal twist mark 308 and a distal twist mark 310 (as shown in FIG. 7). In some examples, the marks 308 and 310 are formed by etching or engraving the marks onto the balloon with a laser, by printing the marks 308, 310 on the balloon, or by cutting slits (which become the marks 308, 310) in the proximal leg 304 and distal leg 306. The twist marks 308 and 310 are aligned along a longitudinal axis 312that is parallel to a central longitudinal axis of the balloon 300. Although the twist marks 308 and 310 are depicted as lines in FIG. 7, in some examples, they can have a different shape such as dashes, triangular, oblong, star-shaped, and / or the like.

[0285] In some examples, the balloon shaping process can include twisting the balloon. As used herein, a “balloon twist” can refer to a circumferential offset between the proximal leg 304 and distal leg 306 of the balloon 300 (as indicated by an offset between the marks 308 and 310, in some examples). One of the shafts of the delivery apparatus coupled to one of the legs of the balloon 300 can be relatively more flexible and twistable than another one of the shafts coupled to other leg of the balloon 300 so that upon inflation of the balloon, the more twistable shaft can twist and rotate the balloon leg coupled to that shaft relative to the other balloon leg. For example, the inner shaft 234 can be configured to twist and rotate the distal leg 306 relative to the proximal leg 304 during balloon inflation. The balloon 300 can be twisted during the balloon shaping process such that upon inflation, the rotatable leg of the balloon (e.g., the distal leg 306) can rotate in a direction that opposes the unfurling of the pleats of the balloon to prevent or minimize rotation of the prosthetic valve.

[0286] During the balloon shaping process, one or more sleeves 332, 334 can be arranged around one or more portions of the pleated and / or folded balloon 300. Compression forces (which may include one or a combination of wrapping, tightening, and / or heating) applied to the one or more sleeves 332, 334 can result in radial compression of the corresponding portions of the balloon 300 and, in some example, inducement of a twist on the balloon 300. This process is explained further below with reference to FIGS. 9A-10C.

[0287] As shown in the example of FIG. 8, a first sleeve 332 is arranged around the proximal cone 303 and a second sleeve 334 is arranged around the main body portion 302.

[0288] In some examples, the sleeves 332, 334 can be shrink tubes that shrink in diameter upon application of heat.

[0289] After the balloon shaping process, the balloon 300 is set into a compressed and deflated state, as shown in FIG. 8. In this state, the balloon 300 can be mounted on a delivery apparatus. A circumferential offset between the twist marks 308 and 310 can be measured to calculate the amount of twist. FIG. 8 shows an example of a -10-degree offset of the distal twist mark 310 from the proximal twist mark 308. This can be referred to as a negative balloon twist (for example, a negative twist of 10 degrees). In some examples, one or moreof the shaping steps, such as pleating, compressing, and / or twisting, can be performed after or during mounting the balloon on the delivery apparatus.

[0290] FIGS. 9A-9C depict examples of a zero twist (FIG. 9A), negative twist (FIG. 9B), and positive twist (FIG. 9C) induced on the balloon 300 during balloon shaping wherein the pleats are folded in a counterclockwise direction with respect to a positive axial direction 314 (in a direction from the proximal end to the distal end of the balloon). When the proximal twist mark 308 and the distal twist mark 310 are circumferentially aligned with one another (for example, they are positioned on a same longitudinal axis 312 that is parallel with a central longitudinal axis of the balloon) after the balloon shaping process, the balloon is characterized as having zero twist (as shown in FIG. 9A). The direction of twist of the balloon (positive or negative) is determined by the angular offset position of the rotatable leg of the balloon relative to the other balloon leg and the direction that the rotatable leg will rotate upon inflation of the balloon. A balloon is said to have a negative twist if the rotatable leg rotates in a direction opposite the unfurling of the pleats when the balloon is rotated during balloon inflation. A balloon is said to have a positive twist if the rotatable leg rotates in the same direction of the unfurling of the pleats when the balloon is rotated during balloon inflation.

[0291] For example, in FIG. 9A, 9B, and 9C, the pleats of the balloon are twisted or furled in the counterclockwise direction 318 and will unfurl in the clockwise direction 316. If the distal leg 306 is allowed to rotate during balloon inflation, a negative twist can be induced on the balloon by angularly offsetting the proximal twist mark 308 from the distal twist mark 310 such that the distal leg 306 rotates in the counterclockwise direction 318 back to its neutral or untwisted position during balloon inflation. This can be accomplished by twisting the distal leg 306 in the clockwise direction 316 and / or twisting the proximal leg 304 in the counterclockwise direction 318 during the balloon shaping process. After twisting the balloon, the distal mark 310 is angularly offset from the proximal mark 308 and the neutral axis 312 in the clockwise direction 316, thus the balloon has a negative twist, as depicted in FIG. 9B. Thus, in this example when the balloon inflates, the pleats unfurl in the clockwise 316 direction, while the distal leg 306 moves back toward the untwisted state in the counterclockwise direction 318 relative to positive axial direction 314. As a result, the negative twist counteracts the rotation from the pleating direction of the balloon duringballoon inflation to prevent or at least minimize rotation of the prosthetic valve between its pre-balloon inflation position and post-balloon inflation position, as described further below.

[0292] Conversely, when the proximal twist mark 308 and the distal twist mark 310 are circumferentially offset from one another after the balloon shaping process, with the distal twist mark 310 angularly offset from the proximal twist mark 308 and the neutral axis 312 in the counterclockwise direction 318, as depicted in FIG. 9C, the balloon has a positive twist. In this case, the distal leg 306 rotates in the clockwise direction 316 back to the neutral axis 312 (the same direction of the unfurling of the pleats) when the balloon is inflated.

[0293] FIGS. 10A-10C depict an exemplary balloon shaping process for inducing a negative twist on the formed balloon 300, where the distal leg 306 can rotate during balloon inflation. In a first stage of the balloon shaping process, as shown in FIG. 10 A, the main body portion 302, proximal cone 303, and distal cone 305 of the balloon 300 are pleated and folded. For example, the main body portion 302, the proximal cone 303 and the distal cone 305 can be pleated and folded such that the pleats and / or folds curve or spiral in a first direction 320 around a central cavity of the balloon 300 and a longitudinal axis of the balloon (for example, counterclockwise when looking down a central longitudinal axis of the balloon 300 from the proximal end to the distal end of the balloon 300).

[0294] In some examples, the pleating and folding can be performed with an apparatus that creates a plurality of pleats and then wraps the pleats around the central cavity of the balloon.

[0295] In a second stage of the balloon shaping process, the balloon 300 is twisted such that the distal leg 306 is circumferentially offset from the proximal leg 304 and has a negative twist. For example, if the balloon is folded in the counterclockwise direction 320, the balloon is twisted such that the distal leg 306 is circumferentially offset from the proximal leg 304 in the clockwise direction. This is illustrated in FIGS. 10B and 10C, which shows the distal twist mark 310 on the distal leg 306 circumferentially offset from the proximal twist mark 308 on the proximal leg 304 by a predetermined amount.

[0296] It should be noted that the pleats of the balloon 300 alternatively can be folded in a clockwise direction 328 (opposite the counterclockwise direction 320). In this example, the balloon 300 would then be twisted such that the distal leg 306 is circumferentially offset from the proximal leg 304 in the counterclockwise direction 320.

[0297] In some examples, twisting the balloon 300 can include manually twisting the balloon 300. The balloon 300 can be manually twisted, for example, by twisting or rotating the distalleg 306 counterclockwise (in the direction indicated by arrow 328) relative to the proximal leg 304 and / or twisting or rotating the proximal leg 304 clockwise relative to the distal leg 306.

[0298] In some examples, the balloon 300 optionally can be placed on a mandrel 322 prior to or after the balloon is manually twisted. In some examples, the proximal leg 304 can be mounted on a proximal end of the mandrel and the distal leg 306 can be mounted to a proximal end of the mandrel such that the distal leg 306 is twisted relative to the proximal leg 304.

[0299] In some examples, the proximal leg 304 can be mounted on a proximal mandrel and the distal leg 306 can be mounted on a distal mandrel and at least one of the mandrels can be rotatable relative to each other. In some such examples, the twist can be created by rotating at least one of the mandrels to rotate a corresponding leg 304, 306 relative to the other leg.

[0300] In some examples, twisting the balloon 300 can additionally or alternatively include compressing (for example, radially compressing) one or more sections of the balloon 300, such as the proximal cone 303 and main body portion 302 of the balloon using sleeves 332 and 334, respectively, thereby adding a twist to the balloon 300. In some examples, the twist can be added to the balloon 300 by manual twisting (with or without a mandrel) alone, or a combination of the manual twisting and the radial compression on the proximal cone 303 and main body portion 302 of the balloon 300 or another section of the balloon.

[0301] FIGS. 10B and 10C show a specific, non-limiting example of a method for twisting the balloon 300. As shown in FIGS. 10B and 10C, the pleated and folded balloon 300 can be mounted on a mandrel 322. In some examples, mounting the pleated and folded balloon 300 on the mandrel 322 can include mounting a first leg of the balloon 300 (for example, the proximal leg 304) on the mandrel 322 and then sliding a second sleeve 334 onto the main body portion 302 of the balloon 300 and a first sleeve 332 onto the proximal cone 303 of the balloon 300. In some examples, the first sleeve 332 and second sleeve 334 are shrink tubes or heat shrink materials. The second leg of the balloon 300 (for example, the distal leg 306) is mounted on the mandrel 322 and twisted manually relative to the first leg (for example, the proximal leg 304) by a set amount of twist.

[0302] The main body portion 302 and proximal cone 303 of the balloon 300 can then be compressed. In some examples, this compression can include radial compression. This canbe done in two phases or stages, including first compressing the proximal cone 303 with the first sleeve 332 (as shown schematically in FIG. 10B by arrow 324).

[0303] In some examples, the compressing can include applying heat and force (such as compression by crimping) to the first sleeve 332, which shrinks in diameter, thereby compressing the proximal cone 303. In some examples, the radial compression on the proximal cone 303 can cause the distal leg 306 to become further circumferentially offset from the proximal leg 304, thereby increasing the negative twist on the balloon 300. FIG.10B depicts the distal twist mark 310 offset from the proximal twist mark 308 because of the manual twisting of the balloon 300, and in some examples, additionally because of the radial compression with the first sleeve 332.

[0304] In a second phase of the compression process, heat and force are applied to the second sleeve 334, as described above, thereby radially compressing this portion of the balloon, as depicted schematically in FIG. 10C by arrow 326. In some examples, the first and second sleeves 332, 334 are heated and compressed simultaneously. In some examples, a sleeve can be placed on the distal cone 305, in lieu of or in addition to the sleeve 332 on the proximal cone 303 and / or the sleeve 334 on the main body portion 302, and the sleeve on the distal cone 305 can be subjected to heat and pressure.

[0305] An amount or degree of the negative twist can vary and be selected based on an expected amount of rotation (in the opposite direction) from the pleating of the balloon, which can vary based on various factors, such as the type of pleating, the number of pleats, the size of the balloon, and / or the type of material of the balloon. In some examples, the negative twist can be in a range of 15 to 90 degrees, 20 to 90 degrees, 25 to 100 degrees, at least 15 degrees, at least 20 degrees, at least 25 degrees, at least 30 degrees, at least 35 degrees, or least 40 degrees, at least 45 degrees, at least 50 degrees, at least 55 degrees, or at least 60 degrees. In some examples, the negative twist can be about 30 degrees.

[0306] For example, in some cases, if the pleats of the balloon are expected to rotate the balloon clockwise by 20 degrees, then the balloon can be formed with a -20-degree twist (negative twist).

[0307] In some examples, if the pleats of the balloon are expected to rotate the balloon clockwise by 20 degrees, then the balloon can be formed with more or less than a -20-degree twist (negative twist) (in such instances, more or less twist may be used to counteract therotations from the pleats). However, the amount of balloon twist can be configured such that a net-zero degree rotation of the balloon results after balloon inflation.

[0308] The balloon shaping process depicted by FIGS. 10A-10C can result in negative balloon twist, such as shown in FIG. 9B.

[0309] The balloon depicted in FIG. 10C can be mounted on a delivery apparatus, such as by bonding (e.g., with an adhesive) or otherwise fixing the proximal and distal legs 304, 306 to components of the delivery apparatus (for example, similar to as shown in FIGS. 2, 5A, and 5B). Once assembled to the delivery apparatus, the one or more sleeves (for example, first sleeve 332 and second sleeve 334) can be removed. A combination of heating and setting the sleeves during the compression processes described above, as well as bonding the proximal and distal legs 304, 306 to rigid components of the delivery apparatus results in setting of the twist such that the twist is locked or held in place.

[0310] FIGS. 11A and 11B depict two different balloons, including a first balloon 330 with zero twist and a second balloon 340 that had an induced negative twist in the deflated state, that have been inflated to an inflated state with a prosthetic valve 350 arranged thereon. The prosthetic valve 350 can be any prosthetic valve, such as the prosthetic heart valve 100 of FIG. 1. In some examples, the second balloon 340 can represent the balloon 300 of FIG. 9B or FIG. 10C, which has a negative twist.

[0311] Each balloon was marked with the proximal twist mark 308 and distal twist mark 310 during balloon manufacturing. During inflation of the first balloon 330 with zero twist (the proximal twist mark 308 and distal twist mark 310 are aligned in the axial direction), the prosthetic valve 350 rotates (due to the pleating direction of the balloon), thereby resulting in its commissure 352 being circumferentially offset from the proximal twist mark 308, as shown in FIG. 11A.

[0312] During inflation of the second balloon 340 with negative twist, the prosthetic valve 350 does not rotate relative to its starting position (prior to inflation), thereby resulting in its commissure 352 being circumferentially aligned with the proximal twist mark 308, as shown in FIG. 11B. In FIG. 11B the distal twist mark 310 is aligned with the proximal twist mark 308 when the balloon 340 is inflated. This is because the balloon untwists, or reverts back to a zero-twist state, as the balloon 340 inflates. For example, as the balloon inflates, the nose cone and distal shoulder of the delivery apparatus (for example, the nose cone 232 and distal shoulder 233 shown in FIG. 5B) can rotate with the distal leg 304 of the balloon 340 (due tothe distal leg 304 being bonded to the nose cone and / or distal shoulder) to allow the balloon to untwist back to or close to its untwisted state. The shaft to which the nose cone and distal shoulder are mounted (e.g., the inner shaft 234) can be configured to torque or twist slightly to allow the rotation to occur so that the balloon untwists back to its untwisted state. Thus, if the ballon pleats are furled in the counterclockwise direction (FIG. 9B), and the balloon initially has a negative twist with the distal mark 310 angular offset in the clockwise direction 316 (FIG. 9B), then upon inflation, the distal leg 306 rotates in the counterclockwise direction, opposite the unfurling of the pleats.

[0313] It should be noted that the techniques for inducing a twist on a balloon can be applied to a delivery apparatus in which the proximal leg 304 can rotate during balloon inflation. In such examples, a negative twist can be induced on the balloon to cause the proximal leg 304 to rotate in a direction opposite the unfurling of the balloon pleats.

[0314] In some examples, both the proximal leg 304 and the distal leg 306 can rotate during balloon inflation. In such examples, a negative twist can be induced by angularly offsetting the proximal leg 304 and the distal leg 306 relative to each other such that the net rotation of the legs 304, 306 is opposite the direction of the unfurling of the pleats. For example, if the balloon pleats unfurl in the clockwise direction, the distal leg 306 rotates in the counterclockwise direction during inflation and the proximal leg 304 rotates in the clockwise direction during inflation but has less rotation than the distal leg 306, the net rotation of the legs 304, 306 is in the counterclockwise direction, opposite the unfurling of the balloon.

[0315] Other techniques and / or mechanisms can be used to twist the balloon. For example, the proximal leg 304 can be rotated relative to the distal leg 306, or vice versa, prior to fixing the proximal and distal legs to respective components of the delivery apparatus.

[0316] FIGS. 12-21 depict examples of inflatable balloons for a prosthetic device delivery apparatus (such as delivery apparatus 200) having different pleat configurations that result in no rotation of a prosthetic valve mounted thereon during inflation of the balloon and radial expansion of the prosthetic valve. In some examples, any of the balloons depicted in FIGS.12-21 can be used in lieu of inflatable balloon 228 in the delivery apparatus 200.

[0317] FIG. 12 is a cross-sectional end view of an inflatable balloon 400 that has a central cavity 402 configured to receive a shaft of a delivery apparatus therethrough (such as inner shaft 234 of delivery apparatus 200) and a plurality of T-shaped pleats 404 that branch off from the central cavity 402 (in a radially outward direction, relative to a central longitudinalaxis 406 of the balloon 400, which is depicted by a dot that indicates the axis extending into and out of the page).

[0318] For example, for each T-shaped pleat 404, a stem of the T branches off the central cavity 402 and a top of the T is spaced radially from the central cavity and extends in a circumferential direction.

[0319] When the balloon 400 inflates (for example, when it is filled with inflation fluid), the T-shaped pleats 404 expand directly radially outward, in the direction depicted by arrows 408 (as opposed to unfurling or expanding in a clockwise or counterclockwise direction). As a result, the pleats 404 do not rotate around the central longitudinal axis 406 as it inflates, which prevents or at least minimizes rotation of a prosthetic valve arranged thereon as the prosthetic is expanded by the balloon.

[0320] FIGS. 13A and 13B depict an inflatable balloon 420 comprising stacked pleats that do not rotate about the central longitudinal axis 406 of the balloon 420 as they expand (as the balloon inflates). For example, FIG. 13A is a cross-sectional end view and FIG. 13B is a perspective view of the balloon 420 which has a central cavity 422 configured to receive a shaft of a delivery apparatus therethrough (such as inner shaft 234 of delivery apparatus 200) and a plurality of interconnected and stacked pleats 424.

[0321] The balloon 420 is pleated such that the pleats 424 are arranged into a plurality of sub-groups 426 of stacked pleats 424 that zig-zag and fold across one another, thereby stacking in the radial direction. The sub-groups 426 are arranged around the central cavity 422 and spaced apart in the circumferential direction. Adjacent sub-groups 426 are connected to one another at either a radially outward (radially outward facing) pleat 428 that extends across two adjacent sub-groups 426 and / or a radially inward (radially inward facing) pleat 430 that extends across two adjacent sub-groups 426. This results in larger groups 432, each comprising two adjacent sub-groups 426 that are interconnected by a radially outward pleat 428.

[0322] When the balloon 420 inflates (for example, when it is filled with inflation fluid), the stacked pleats 424 in their groups 432 expand directly radially outward, in the direction depicted by arrows 408. As a result, the pleats 424 of the balloon 420 will not rotate (in a direction around the central longitudinal axis 406) as the balloon 420 inflates, thereby preventing or at least minimizing rotation of the prosthetic valve as is radially expands.

[0323] FIGS. 14A and 14B are cross-sectional end views of an inflatable balloon 440 in a deflated state (FIG. 14A) and a partially inflated state (FIG. 14B). The balloon 440 has a central cavity 442 configured to receive a shaft of a delivery apparatus therethrough (such as inner shaft 234 of delivery apparatus 200) and a plurality of spiral pleats 444 and 445. It should be noted that while FIG. 14A depicts spaces between the pleats 444 and 445 for purposes of illustration, when arranged on a delivery apparatus (such as delivery apparatus 200) in a compressed and deflated configuration, the pleats 444 and 445 can be more tightly wound into their spiral configuration against one another and / or against or adjacent to the central cavity 442.

[0324] As shown in FIG. 14A, the balloon 440 is pleated such that each pleat 444 and 445 forms a spiral that spirals in either a first direction (for example, clockwise) or a second direction (for example, counterclockwise) about a respective axis that is parallel to and radially spaced from a central longitudinal axis 446 of the balloon 440. The balloon 440 comprises an equal number of pleats 444 that spiral in the first direction and pleats 445 that spiral in the second direction.

[0325] For example, as shown in FIG. 14A, the balloon 440 comprises two pleats 444 that spiral in the first direction and two pleats 445 that spiral in the second direction. The two pleats 444 are arranged diagonally across the central cavity 442 from one another and the two pleats 445 are arranged diagonally across the central cavity 442 from one another. Thus, each pleat 444 is arranged adjacent to and spirals towards a respective pleat 445.

[0326] When the balloon 440 inflates (for example, when it is filled with inflation fluid), the spiral pleats 444, 445 uncurl or unfurl and expand directly radially outward, in the direction depicted by arrows 408. In a partially inflated state, as shown in FIG. 14B, this results in a plurality of triangular sections 448 branching off the central cavity 442. As the balloon 440 continues to inflate, the intersection points 450 between adjacent triangular section 448 move radially outward to fully inflate the balloon 440 (for example, into a circular or oval cross-sectional shape). Because the spiral pleats 444, 445 uncurl radially outwardly rather than unfurling in a direction around central axis 446, rotation of a prosthetic valve arranged thereon can be prevented or minimized. Any rotational forces imparted onto the prosthetic valve from a single spiral pleat 444, 445 is counteracted by an adjacent pleat 444, 445 that uncurls in the opposite direction. Thus, the net rotational force imparted by the balloon to the prosthetic valve during balloon inflation is zero.

[0327] FIGS. 15A and 15B are cross-sectional end views of an inflatable balloon 460 in a deflated state (FIG. 15A) and a partially inflated state (FIG. 15B). The balloon 460 is similar to the balloon 440, except is has three pairs of spiral pleats 464 and 465 (which may be the same as pleats 444 and 445, as described above) instead of the two pairs shown in FIG. 14A. For example, similar to the balloon 440, the balloon 460 has a central cavity 462 configured to receive a shaft of a delivery apparatus therethrough (such as inner shaft 234 of delivery apparatus 200) and a plurality of spiral pleats 464 and 465 that are grouped to together in pairs of one spiral pleat 464 that spirals in the first direction and one spiral pleat 465 that spirals in the second direction. It should be noted that while FIG. 15A depicts spaces between the pleats 464 and 465 for purposes of illustration, when arranged on a delivery apparatus (such as delivery apparatus 200) in a compressed and deflated configuration, the pleats 464 and 465 can be more tightly wound into their spiral configuration against one another and / or against or adjacent to the central cavity 462.

[0328] When the balloon 460 inflates (for example, when it is filled with inflation fluid), the spiral pleats 464, 465 uncurl or unfurl and expand directly radially outward, in the direction depicted by arrows 408. In a partially inflated state, as shown in FIG. 15B, this results in a plurality of triangular sections 468. As the balloon 460 continues to inflate, the intersection points 469 between adjacent triangular section 468 move radially outward to fully inflate the balloon 460. Because the spiral pleats 464, 465 uncurl radially outwardly rather than unfurling in a direction around central axis 466, rotation of a prosthetic valve arranged thereon can be prevented or minimized. Any rotational forces imparted onto the prosthetic valve from a single spiral pleat 444, 445 is counteracted by an adjacent pleat 444, 445 that uncurls in the opposite direction. Thus, the net rotational force imparted by the balloon to the prosthetic valve during balloon inflation is zero.

[0329] FIG. 16 is a cross-sectional end view of an inflatable balloon 470 that has a central cavity 472 configured to receive a shaft of a delivery apparatus therethrough (such as inner shaft 234 of delivery apparatus 200) and two groups of pleats 474 and 475 that branch off from the central cavity 402 (in a radially outward direction, relative to a central longitudinal axis 476 of the balloon 400, which is depicted by a dot going into and out of the page). The pleats 474 and 475 are similar to the pleats 230 shown in FIG. 6, except they are arranged into a first group of pleats 474 that curve or arc around the central cavity 472 in a firstdirection and a second group of pleats 475 that curve or arc around the central cavity 472 in an opposite, second direction. In some examples, each group has the same number of pleats.

[0330] For example, as shown in FIG. 16, the balloon 470 comprises four pleats 474 folded against one another and spiraling in a clockwise direction and four pleats 475 folded against one another and spiraling in a counterclockwise direction. In some examples, the balloon 470 can comprise more or less that four pleats 474 and 475, such as three, five, six, of the like. The equivalent number of pleats 474 and pleats 475 results in the rotation from each group of pleats 474 and 475, as the pleats unfurl in opposite directions, to counteract each other, thereby preventing overall rotation of the balloon 470 relative to the inner shaft of the delivery apparatus as it inflates.

[0331] For example, when the balloon 470 inflates (for example, when it is filled with inflation fluid), the pleats 474 unfurl and expand in the first direction depicted by arrow 478 (which is opposite the folding or spiraling direction of the pleats 474 in the pleated state of FIG. 16), and the pleats 475 unfurl and expand in the second direction depicted by arrow 479 (which is opposite the folding or spiraling direction of the pleats 475 in the pleated state). As a result, the net rotational force imparted to the prosthetic valve during balloon inflation is zero. Consequently, net rotation of a prosthetic valve arranged thereon during balloon inflation can be avoided. For example, a rotational position of the prosthetic valve relative to the delivery apparatus prior to and after balloon inflation can be unchanged or substantially unchanged.

[0332] FIG. 17 is a cross-sectional end view of an inflatable balloon 480 that has a central cavity 482 configured to receive a shaft of a delivery apparatus therethrough (such as inner shaft 234 of delivery apparatus 200) and a plurality of zig-zagging pleats 484 that each branch off from the central cavity 402 (in a radially outward direction, relative to a central longitudinal axis 406 of the balloon 400, which is depicted by a dot illustration the axis going into and out of the page).

[0333] The pleats 484 can be spaced circumferentially apart from one another such that each pleat 484 is spaced apart from adjacent pleats 484.

[0334] Each pleat 484 is folded over itself multiple times to form a stack of zig-zagging folds. The folds of adjacent pleats 484 are not directly connected to one another. Instead, each pleat 484 is individually connected to the central cavity 482.

[0335] Although the balloon 480 is depicted with four individual pleats 484 in FIG. 17, in some examples the balloon 480 can have more or less than four pleats 484 (such as two, three, five, six, or the like). However, all the pleats 484 of the balloon 480 can be spaced equidistant from one another.

[0336] When the balloon 480 inflates (for example, when it is filled with inflation fluid), the zig-zagging pleats 484 expand directly radially outward, in the direction depicted by arrows 408. As a result, the pleats 484 do not rotate in a direction around the central longitudinal axis 486 as it inflates, and consequently rotation of a prosthetic valve arranged thereon during balloon inflation can be avoided.

[0337] In some examples, the balloons described herein (such as the balloons 400, 420, 440, 460, 480, 1000, 1020, and / or 1060) can be shaped using a two-stage process. In some examples, prior to shaping the balloon, the balloon can be formed by blow molding a cylindrical parison. The two-stage shaping process can include a first stage of “pleating” the balloon which can involve shaping the blow molded balloon to have pleats with an intermediate geometry that resemble, but are radially expanded compared to, the final, compressed and folded shape of the balloon. For example, FIG. 18A depicts a balloon 490 having such an intermediate geometry after a first pleating stage in which the balloon defines a central cavity 492 and a plurality of bulbous or petal-shaped pleats or sections 494 that each extend radially outward from the central cavity 492.

[0338] A second stage in this shaping process involves “folding” or compressing the pleats (for example, pleats or petal-shaped sections 494) having the intermediate geometry radially inward into their final compressed and set shape. FIG. 18B shows an example of the balloon 490 after being folded and / or compressed into its final shape. The balloon shown in FIG. 18B has a larger central cavity 492 (as compared to the pleated state shown in FIG. 18 A) and the petal-shaped sections 494 have been compressed down (in a radially inward direction, toward the central longitudinal axis of the balloon 490) to form T-shaped pleats or sections 496. As described above with reference to FIG. 12, this shape of the deflated balloon 490 prevents or at least minimizes the balloon (and thus the prosthetic valve arranged thereon) from rotating during inflation. The final, pleated and folded (or compressed) balloon 490 can then be coupled to the delivery apparatus and receive a radially compressed prosthetic valve thereon.

[0339] In some examples, the two-stage process can be performed with a “pleat and fold” machine or apparatus that comprises a pleat head that performs the first stage described above. A fold head or machine can then perform the second stage described above.Examples of different pleat heads for shaping various balloons, such as those described above, are depicted in FIGS. 29, 32, 33, 35, and 36, which are described in further detail below.

[0340] In some examples, the balloons described herein (such as the balloons 400, 420, 440, 460, 480, 1000, 1020, and / or 1060) can be shaped using a portion of the two-stage process described herein. For example, the balloons described herein may be formed by pleating only, pleating and folding without radially compressing, or pleating and radially compressing (without folding.

[0341] For example, FIGS. 29-37 depict additional examples of shaping inflatable balloons with the above-described two-stage “pleat and fold” process.

[0342] For example, FIG. 29 is a cross-sectional view of an exemplary die 1010 (which, in some examples, can be a metal die) used to form a balloon 1000 with bulbous-shaped pleats 1004 that are expanded and that have not yet been folded or radially compressed (as shown in FIG. 30).

[0343] In some examples, the die 1010 can comprise a plurality of movable plates 1012 that are configured to pleat a balloon into the shape shown in FIG. 30. For example, a central cavity of the die 1010 can receive the balloon (e.g., the blow molded balloon that is not yet pleated) and the plates 1012 can be moved radially inward until the central cavity transforms into the shape shown in FIG. 29, which includes a central-most cavity 1014 and a plurality of bulbous cavities 1016 branching radially outward from the central-most cavity 1014. As a result, the balloon 1000 is shaped into the balloon shape shown in FIG. 30, which includes bulbous-shaped pleats 1004.

[0344] The balloon 1000 can then be folded and radially compressed (for example, using the “fold” head or machine, or manually) and set into the final shape of the balloon 1000 shown in FIG. 31. The folding and radially compressing operation can include applying pressure to and pressing the bulbous pleats 1004 radially inward toward and / or against the central cavity 1002. This final compressed and set shape of the balloon 1000, as shown in FIG. 31, has T-shaped pleats 1004. The balloon 1000 is similar to the balloon 400, as described above, except it includes eight pleats 1004 instead of four pleats.

[0345] FIGS. 32-34 depict an example of shaping a balloon 1020 into a shape having double T-shaped pleats 1024 extending radially outward from a central cavity 1022 of the balloon 1020. The balloon 1020 is similar to the balloon 420, as described above, except the balloon 1020 includes pleats 1024 (or pleat groups, which correspond to the pleat groups 432) that have two levels of radially stacked pleats instead of three.

[0346] To shape the balloon 1020 shown in FIG. 34, a balloon without pleats (e.g., a cylindrically shaped balloon) can be inserted into a die 1030, with the plates 1032 of the die in a retracted position (thereby forming a larger central cavity for receiving the balloon). The plates 1032 can then be moved radially inward to the position shown in FIG. 32. In this position, the plates 1032 form a central-most cavity 1034 and a plurality of double bulbed cavities 1036 branching radially outward from the central-most cavity 1034. As a result, the balloon 1020 is pleated into the balloon shape shown in the magnified view of FIG. 33. This pleated shape comprises a plurality of radially expanded pleats 1024 having a double bulbed shape.

[0347] The balloon 1020 can then be folded and radially compressed (for example, using the “fold” head or machine, or manually) by pressing the expanded pleats 1024 (shown in FIG.33) radially inward to form the double T-shaped pleats 1024 and setting the balloon 1020 into the final shape shown in FIG. 34. As described above, this final compressed and set shape of the balloon 1020, as shown in FIG. 34, has double T-shaped pleats that are folded more tightly against the central cavity 1022 of the balloon 1020 than the pleated shape shown in FIG. 33.

[0348] FIG. 35 depicts an example of a die 1050 for shaping (for example, pleating) a balloon 1040 to have a plurality of zig-zagging pleats 1044 that branch off and extend radially outward from a central cavity 1042 of the balloon 1040. As described above, during this first stage of the shaping process, the plates 1052 of the die 1050 are pressed radially inward to shape the balloon 1040 into a balloon shape having zigzag shaped pleats 1044. During a second stage of the shaping process, similar to as described above for FIGS. 29-34, the balloon 1040 is compressed radially inward and set into a compressed shape where the pleats 1044 are folded more tightly against the central cavity 1042. In some examples, the pleats 1044 can look similar to the pleats 484 of the balloon 480 (FIG. 17), as described above.

[0349] In some examples, as shown in FIG. 35, the balloon 1040 can have a plurality of pairs of adjacently arranged pleats 1044, where the pleats 1044 in each pair zigzag in an opposite direction from one another. The pairs of pleats 1044 are spaced circumferentially apart from one another. Although four pairs of pleats 1044 are shown in FIG. 35, in some examples, the balloon 1040 can have more or less that four pairs of pleats 1044 (such as two, three, five, or the like).

[0350] FIGS. 36A-40 depict an example of a balloon 1060 and shaping the balloon 1060 into a shape having pleats 1064 that extend outward from a central cavity 1062 of the balloon 1060, resulting in a balloon 1060 having an approximate shape of a number sign, hashtag, or pound sign with a circular center section (prior to folding). The pleats 1064 can be arranged into pairs of perpendicularly arranged pleats. For example, each pair 1066 can include two pleats 1064 that extend perpendicular to one another.

[0351] The pleats 1064 of the balloon 1060 can then be folded, radially compressed and set into the final shape shown in FIGS. 38-40. FIGS. 39 and 40 are cross-sectional views of different sections of the balloon 1060 shown in FIG. 38. When the balloon 1060 inflates, the pleats 1064 can unfold and junctions 1068 between the pleats 1064 of each pair 1066 can expand directly radially outward, thereby preventing rotation of the balloon 1060.

[0352] To shape the balloon 1060 shown in FIG. 37, a balloon 1058 without pleats (e.g., a cylindrically shaped balloon) can be inserted into a die 1070, with the plates 1072 of the die in a retracted or radially outward position (thereby forming a larger central cavity for receiving the balloon), as shown in FIG. 36A. The plates 1072 can be moved radially inward, as shown in FIG. 36B, to shape the balloon 1060 into the shape shown in FIG. 37. This pleated shape comprises a plurality of pleats 1064 arranged into pairs 1066 of perpendicularly arranged pleats 1064.

[0353] The balloon 1060 can then be folded and / or radially compressed (for example, using the “fold” head or machine, or manually) and set into the final shape of the balloon 1060 shown in FIGS. 38-40. In some examples, different sections of the balloon 1060 can have different folded cross-sectional shapes, due to an amount of balloon material in that section. For example, an exemplary cross-section of the main body portion 1061 of the balloon 1060 is shown in FIG. 40 and an exemplary cross-section of a distal cone 1065 of the balloon 1060 is shown in FIG. 39. In some examples, the proximal cone 1063 of the balloon 1060 has a same or similar cross-sectional shape to that of the distal cone 1065. As shown in FIG. 38.the distal cone 1065 (and, in some examples, the proximal cone 1063) can have a plurality of T-shaped pleats 1064 in the folded and compressed configuration. As shown in FIG. 39, the main body portion 1061 can comprise a couple T-shaped pleats 1064 and a few pairs of radially extending pleats 1064. Since the main body portion 1061 can comprise more balloon material, not all of the pleats 1064 form the T-shape.

[0354] In some examples, as shown in FIGS. 38 and 40, a sleeve 1067 can be arranged around a portion of the folded and compressed balloon 1060, such as around the main body portion 1061, thereby holding the pleats 1064 in place during the manufacturing process. In some examples, the sleeve 1067 can be a shrink tube that functions to set (or “lock”) the shape of the pleats 1064 during folding and compression so that when the sleeve 1067 is removed, the balloon 1060 maintains it shape. In some examples, the shrink tube is configured to shrink in diameter and enable the setting of the pleats upon application of heat.

[0355] FIGS. 54-55C depict an example of shaping a balloon 1080 into a shape having a plurality of L-shaped pleats 1084 (or angled or approximately L-shaped pleats) extending radially outward from a central cavity 1082 of the balloon 1080. In some examples, as shown in FIGS. 54 and 55A, the pleats 1084 are grouped into pairs of L-shaped pleats 1084, where the pleats 1084 of each pair 1086 face one another (for example, such that one L-shaped pleat 1084 of the pair 1086 is in a “forward” orientation and the other L-shaped pleat 1084 of the pair 1086 is in a “backward” orientation) with an end of each L-shaped pleat 1084 of the pair 1086 branching off the central cavity 1082 at a same or approximately same location.

[0356] To shape the balloon 1080 shown in FIG. 54, a balloon without pleats (e.g., a cylindrically shaped balloon) can be inserted into a die 1090, with the plates 1092 of the die 1090 in a retracted position (thereby forming a larger central cavity for receiving the balloon). The plates 1092 can then be moved radially inward to the position shown in FIG.54. In this position, the plates 1092 form a central cavity 1082 and a plurality of pairs of pleats 1084 branching outward from the central cavity 1081.

[0357] The balloon 1080 can then be removed from the die 1090 (as shown in FIG. 55 A) and folded and radially compressed (for example, using the “fold” head or machine, manually, or with a funnel-type folding tool, as described further below with reference to FIGS. 58-61) by pressing the expanded pleats 1084 (shown in FIG. 55 A) radially inward. For example, pleats 1084 of a first two oppositely arranged pairs 1086 (arranged across the central cavity 1082 from one another) are folded over themselves once, such that the pleats 1084 of each pair1086 of the first two oppositely arranged pairs 1086 are folded toward each other (as shown in FIG. 55B). Pleats 1084 of a second two oppositely arranged pairs 1086 (arranged across the central cavity 1082 from one another) are folded over themselves once, such that the pleats 1084 of each pair 1086 of the second two oppositely arranged pairs 1086 are folded toward each other (as shown in FIG. 55C). The ends of each folded pleat 1084 of the second two oppositely arranged pairs 1086 overlap an adjacent folded pleat 1084 of the first two oppositely arranged pairs 1086 (as shown in FIG. 55C). The final compressed and set shape of the balloon 1080, as shown in FIG. 55C, has four pairs of folded pleats 1084 that overlap and are folded more tightly against the central cavity 1082 of the balloon 1080 than the pleated shape shown in FIG. 54.

[0358] FIG. 56 and 57 depict additional exemplary folding patterns for the pleated balloon 1080 depicted in FIG. 55A (the pleated balloon form that can be produced using the die 1090, for example). As shown in FIG. 56, the balloon 1080 can be folded such that the pleats 1084 of each pair 1086 form an interior fold 1083 with a portion of the balloon 1080 that connects the two pleats 1084 of the pair 1086. The end portions of the two pleats 1084 of each pair 1086 are further folded over themselves such that the pleats 1084 are folded away from each other, thereby forming outer folds 1085. The outer folds 1085 overlap the interior fold 1083 in the radial direction. Together, the length of the two outer folds 1085 (of the pair 1086), measured in the circumferential direction, is approximately the same as the length of the interior fold 1083. As a result, connecting portions 1087 are formed between adjacent pairs 1086 of folded pleats 1084. This folding pattern is repeated for each pair 1086.

[0359] As shown in the example of FIG. 57, in some examples, the balloon 1080 can be folded such that the pleats 1084 of each pair 1086 form an interior fold 1083 with a portion of the balloon 1080 that connects the two pleats 1084 of the pair 1086. The end portions of the two pleats 1084 of each pair 1086 are further folded over themselves such that the pleats 1084 are folded away from each other, thereby forming outer folds 1085. The outer folds 1085 overlap the interior fold 1083 in the radial direction but extend circumferentially past opposing ends of the interior fold 1083. That is, together, the length of the two outer folds 1085, measured in the circumferential direction, is longer than the length of the interior fold 1083. In some examples, as shown in FIG. 57, a free end of each outer fold 1085 can extend toward and / or contact a free end of an adjacent outer fold 1085 of an adjacent pair 1086. This folding pattern is repeated for each pair 1086.

[0360] FIGS. 58-61 depict a folding tool 1400 that can be used to fold any of the pleated balloons described herein. For example, the folding tool 1400 can be configured to receive a pleated balloon, such as the pleated balloon 1080 depicted in FIG. 55 A, and fold and radially compress the balloon into its final compressed shape (such as one of the shapes shown in FIGS. 55C, 56, or 57).

[0361] As shown in FIGS. 58 and 59, the folding tool 1400 can comprise a first body 1402 that has a first end 1404 and a second end 1406. The length of the first body 1402 is defined in an axial direction (relative to a central longitudinal axis 1405 of the folding tool 1400), between the first end 1404 and the second end 1406. In some examples, the length is larger than the width or diameter of the first body 1402 and thus can be referred to as an elongated first body 1402.

[0362] The first body 1402 can comprise a central bore 1408 extending axially therethrough from the first end 1404 to the second end 1406 of the first body 1402. The central bore 1408 can be centered along the central longitudinal axis 1405 of the folding tool 1400 and has a diameter 1410 (shown in FIGS. 59-60C). The central bore 1408 is configured to receive a central portion of a pleated balloon (such as the central portion of the balloon 1080 defining the central cavity 1082, as depicted in FIG. 55A).

[0363] In some examples, the diameter 1410 changes (e.g., increases) from the first end 1404 to the second end 1406. For example, FIGS. 60A-60C depict three cross-sections taken along section lines (shown in FIG. 59) near the first end 1404 (FIG. 60 A), an intermediate portion that is between the first end 1404 and second end 1406 (FIG. 60B), and near the second end 1406 (FIG. 60C). As depicted in FIGS. 60A-60B, the diameter 1410 of the central bore 1408 can be larger at the location of the cross-section 60C-60C than at the location of the crosssection 60A-60A.

[0364] As shown in FIGS. 58 and 60A-60C, the first body 1402 can comprise a plurality of channels 1412a-1412h (which can be collectively referred to as channels 1412) spaced circumferentially apart around the central bore 1408. Each channel can extend radially outward from the central bore 1408 (relative to the central longitudinal axis 1405) and extend axially from the first end 1404 to the second end 1406 of the first body 1402. In some examples, as depicted in the cross-sectional views of FIGS. 60A-60C, each channel 1412 changes shape along its length, as measured in the axial direction between the first end 1404 and the second end 1404.

[0365] For example, at the first end 1414 of each channel 1412 (located at or near the first end 1404 of the first body 1402), each channel 1412 can have a first shape that is shaped to receive a respective pleat of a pleated balloon (such as a pleat 1084 of the balloon 1080 depicted in FIG. 55A).

[0366] At the second end 1416 of each channel 1412 (located at or near the second end 1406 of the first body 1402), each channel 1412 can have a second shape (or geometry) that is an optimal shape for the pleat before radially compressing the pleat radially inward toward a central portion of the balloon. The second shape is different than the first shape and allows the pleats to be radially compressed into a target folding pattern (for example, one of the folding patterns depicted in FIGS. 55C-57).

[0367] Thus, the shape of each channel 1412 can change along its length, from its first end 1414 to its second end 1416. An example of the changing shape of the channels is depicted by the cross-sectional views of FIGS. 60A-60C. Looking at a first channel 1412a and a second channel 1412b, in the cross-section of FIG. 60 A, near the first end 1404, the first channel 1412a and second channel 1412b each have an approximate L shape with the respective longer legs of the L-shaped channels angled toward one another. At the intermediate portions of the first channel 1412a and second channel 1412b, as depicted in the cross-section of FIG. 60B, the first channel 1412a and second channel 1412b are relatively straight (no longer L shaped) and extend almost directly radially outward from the central bore 1408 such that they are approximately parallel to one another. Near the second end 1406, the first channel 1412a and second channel 1412b are relatively straight (no longer L-shaped and shorter than in the first cross-section at the first end 1404) and angled toward one another. The channels 1412 are all shorter at their second ends 1416, as compared to their first ends 1414, and the diameter 1410 of the central bore 1408 is larger.

[0368] It should be noted that FIGS. 58-60C depict an example of the changing shapes of the channels 1412 and these shapes can vary for different target folding patterns of the balloon (for example, for the different folding patterns shown in FIGS. 55C, 56, and 57).

[0369] As shown in FIGS. 58 and 59, in some examples, the folding tool 1400 comprises a second body 1420 that is configured to be coupled to the first body 1402. The second body 1420 has a first end portion 1422 and second end portion 1424 and comprises a central channel 1426 that tapers radially inward from the first end portion 1422 to the second end portion 1424. For example, the first end 1428 of the central channel 1426 can be locatedwithin the first end portion 1422 and has a first diameter 1430. The second end 1432 of the central channel 1426 is located at a terminal end of the second end portion 1424 and has a second diameter 1434 that is smaller than the first diameter 1430.

[0370] In some examples, the central channel 1426 has a conical shape (as shown in FIG. 61) that is configured to radially compress the pleats of the inflatable balloon against the central portion (or central cavity) of the inflatable balloon. For example, the central channel 1426 is defined by a radially inward facing surface 1436 of the second body 1420 that tapers continuously from the first diameter 1430 at the first end 1428 of the central channel 1426 to the second diameter 1434 at the second end 1432 of the central channel 1426. In this way, the radially inward facing surface 1436 provides a relatively smooth surface for the pleats of the balloon to slide along for folding radially inward.

[0371] In some examples, the first body 1402 can comprise a first mating interface 1438 at its second end 1404. The first mating interface 1438 can be configured to couple to a second mating interface 1440 of the second body 1420 of the folding tool 1400.

[0372] In some examples, as shown in FIG. 58, the first mating interface 1438 can comprise one or more axially extending slots 1442 that extend from the second end 1406 of the first body 1402 toward the first end 1404 of the first body 1402. In some examples, each slot 1442 extends axially from the first end 1404 toward an intermediate portion of the first body 1402.

[0373] In some examples, the first mating interface 1438 can comprise an annular channel 1444 that flares radially outward as it extends axially from the second end 1406 of the first body 1402 toward the first end 1404 of the first body 1402. The annular channel 1444 can be disposed radially outward from the central bore 1408 and plurality of channels 1412.

[0374] The annular channel 1444 can be disposed radially inward from the one or more axially extending slots 1442. In some examples, each of the one or more axially extending slots 1442 extend radially from a radially outward facing surface 1446 of the first body 1402 into the annular channel 1444.

[0375] The annular channel 1444 and / or axially extending slots 1442 can extend axially into the first body 1402 from the second end 1406 by a distance 1448 (shown in FIG. 59) that is smaller than half the total length of the first body 1402 (where the total length is measured from the first end 1404 to the second end 1406).

[0376] In some examples, as shown in FIGS. 58 and 61, the second mating interface 1440 can comprise an annular extension 1450 that has a radially inward facing surface 1452 defining a lumen that is proximal to and continuous with the central channel 1426. The annular extension 1450 has a radially outward facing surface 1454 that, in some examples, tapers radially inward (toward the central longitudinal axis 1405) from the first terminal end 1456 of the second body 1420 to an axial location of the first end 1428 of the central channel 1426.

[0377] The second mating interface 1440 can further comprise one or more axially extending protrusions 1458 that protrude radially outward from and extend axially along the radially outward facing surface 1454 of the annular extension 1450. When the one or more axially extending protrusions 1458 comprise multiple protrusions, the protrusions are spaced circumferentially apart from one another around the annular extension 1450.

[0378] In some examples, the annular extension 1450 of the second mating interface 1440 is shaped to fit within the annular channel 1444 of the first mating interface 1438.

[0379] In some examples, the one or more axially extending protrusions 1458 of the second mating interface 1440 are shaped to fit within respective axially extending slots 1442 of the first mating interface 1438.

[0380] When the first and second mating interfaces 1438, 1440 are coupled together, the first end 1428 of the central channel 1426 of the second body 1420 is disposed adjacent to second ends 1416 of the plurality of channels 1412 and central bore 1408 at the second end 1406 of the first body 1402.

[0381] In use, a pleated balloon (such as the pleated balloon shown in FIG. 55A) can be inserted into the first end 1404 of the first body 1402, with each pleat being inserted into a respective channel 1412. For example, prior to inserting the balloon 1080 into the first body 1402, the balloon 1080 can be pleated to form pleats 1084. Each pleat 1084 can be inserted into a respective channel 1412. The pleated balloon can be pushed or pulled through the first body 1402. The balloon can be mounted around a mandrel as it is advanced through the folding tool 1400. As the pleats of the balloon travel through the channels 1412, the pleats are moved or folded into a geometry or shape that matches that of the changing channels 1412. Thus, once the balloon reaches the second end 1406 of the first body 1402, the pleats can have a different shape than before and when entering the first body 1402 (such as a shape complementary to that of the channels 1412 at their second ends 1416, as shown in FIG.60C). In some examples, the balloon can have a shape similar to that shown in the crosssection of FIG. 60C. This shape can, in some examples, ensure that one pleat always goes under the adjacent or neighboring pleat. For example, the pleat shaped according to channel 1412a can be shaped so that it gets folded under the pleat shaped according to the adjacent channel 1412b as the balloon passes through the second body 1420, as explained below.

[0382] The balloon can continue to be pushed or pulled directly into the central channel 1426 of the second body 1420 when the second body 1420 is coupled to the first body 1402 (e.g., via the first mating interface 1438 and second mating interface 1440). As the balloon travels through the central channel 1426 of the second body 1420 the pleats of the balloon are compressed further radially inward with the decreasing diameter of the central channel 1426. At the second end 1432 of the central channel 1426, the pleats can be radially compressed against the central portion of the balloon. Upon exiting the folding tool 1400, the folded shape of the balloon can be the same as or similar to the shape of the balloon shown in FIG.55C. However, as explained herein, the shapes and orientations of the channels 1412 can be adapted for different target folded balloon configurations. The folded shape of the balloon can be retained in the radially compressed configuration, for example, by inserting it into a sheath or shrink tubing that holds the folded pleats of the balloon in place. In some examples, once inside the shrink tubing, the folded balloon can be further radially compressed to result in its final folded and radially compressed shape (such as the shape depicted in FIG. 55C).

[0383] FIGS. 19-21 depict an exemplary balloon mold design and process for forming a balloon 500 into a shape having triangular-shaped wings 504 that expand directly radially outward from a central cavity 502 of the balloon 500 (as shown in FIG. 21) and enable the balloon 500 to remain stationary in a circumferential direction and not rotate as it inflates. As shown in FIG. 21, the formed balloon 500 comprises four wings 504 that are wider at their end (which can be referred to as “free ends”) than where they connect to the central cavity 502 (which can be referred to as “attached ends”). The wings 504 are spaced equidistant around the central cavity from one another (for example, in the circumferential direction).

[0384] The balloon 500 shown in FIG. 21 may be formed by first forming (for example, by blow molding) a polygon shaped balloon 510, as depicted in FIG. 19. The polygon shaped balloon 510 shown in FIG. 19 has a body 512 defined by four sides 514 and conical endportions 516. The balloon 510 can be formed by blow molding a cylindrical parison in a first mold, which can have a rectangular inner cavity, resulting in a similarly shaped balloon 510.

[0385] The sides 514 can meet at right angles. As such, the body 512 of the polygon shaped balloon 510 can have a cuboid shape.

[0386] In some examples, the balloon 500 can comprise more or less than four wings 504, such as three, five, six, or the like. However, in such cases, the starting polygon shape may be different than shown (for example, having three, five, six, or the like, sides 514).

[0387] The polygon shaped balloon 510 can be folded along the dashed lines 518 shown in FIG. 19 by pressing the balloon radially inwardly along lines 518, thereby roughly resulting in the shape of the balloon 500 shown in FIG. 21 (having four wings 504). This four- winged balloon is then inserted into a second, forming mold 520 (which can be referred to as a die) to form and set the final shape of the balloon 500. The forming mold 520 can comprise an annular ring 522 with four wedges 524 that are spaced circumferentially apart around the ring 522 and extend radially inward from the ring 522 to a center of the forming mold 520.

[0388] The process of inserting the balloon into the forming mold 520 can be a secondary molding or reforming process that follows the initial forming into the polygon shaped balloon 510. The resulting balloon 500 shown in FIG. 21 can evenly expand when inflated, without pleats that rotate around a central longitudinal axis of the balloon when inflated.

[0389] In some examples, instead of inserting the polygon shaped balloon 510 into the forming mold 520, a balloon parison (e.g., having a cylindrical shape) can be inserted into and blow molded within the forming mold 520 to form the balloon 500 in the shape of the forming mold 520.

[0390] FIGS. 22A-24 depict examples of balloons having repeating pleat designs that do not have a directional bias or are alternating such that any directional bias is counteracted throughout the balloon. As a result, these balloons can inflate without rotating. In some examples, any of the balloons depicted in FIGS. 22A-24 can be used in lieu of inflatable balloon 228 in the delivery apparatus 200.

[0391] Turning first to FIGS. 22A and 22B, a formed first balloon 600 and a formed second balloon 610 having origami-like pleat designs with no orientation or directional bias in the circumferential direction are respectively shown. The pleat designs of the first balloon 600 and the second balloon 610 can mimic a stent or frame of prosthetic valve (such as frame102) that uniformly opens and expands during the radial expansion process, without pleats that rotate around a central longitudinal axis of the balloon when inflated.

[0392] As shown in FIG. 22A, the first balloon 600 can comprise a plurality of rhomboidshaped pleats 606 extending from a first end 602 to a second end 604 of the balloon 600 and around a circumference of the balloon 600. The rhomboid-shaped pleats 606 can be grouped into axially extending (from the first end 602 to the second end 604) rows 608 of the rhomboid-shaped pleats 606 arranged in an arrow-shaped pattern.

[0393] As shown in FIG. 22B, the second balloon 610 can comprises a plurality of elongated hexagonal-shaped pleats 616 extending in an alternating pattern from a first end 612 to a second end 614 of the balloon 610. The pleats 616 are elongated, or have their longest dimension, extending in a direction of a central longitudinal axis 615 of the balloon 610. Each pleat 616 can comprises one or more folds extending along its length. This gives the folded or deflated balloon 610 a faceted or origami-like shape. The pleats 616 do not have a rotational directional bias (for example, they are not pleated or folded in one direction around the circumference of the balloon 610).

[0394] Since the pleats 606 of the first balloon 600 and the pleats 616 of the second balloon 610 do not have a directional bias in the circumferential direction, when they are inflated, the pleats expand uniformly in a radially outward direction, thereby inflating without rotating.

[0395] FIG. 23 depicts a formed balloon 630 comprising a plurality of circumferentially extending rows of angled pleats. A group of first rows 632 comprise pleats 634 angling in a first direction around the balloon 630, relative to a central longitudinal axis 635 of the balloon 630 and a group of second rows 636 comprise pleats 638 angling in a second direction around the balloon 630.

[0396] As shown in FIG. 23, the first rows 632 and second rows 636 alternate with one another from a first end 640 to a second end 642 of the balloon 630.

[0397] In some examples, two consecutive first rows 632 can be arranged adjacent to two consecutive second rows 636.

[0398] In some examples, the pleats 634 in the first rows 632 can angle at a non-zero angle relative to the central longitudinal axis 635, in a clockwise direction around the central longitudinal axis 635. The pleats 638 in the second rows 636 can angle at a non-zero angle relative to the central longitudinal axis 635, in a counterclockwise direction around the central longitudinal axis 635.

[0399] The balloon 630 comprises an equal number of first rows 632 and second rows 636. Thus, the rotational bias of the first rows 632 and the second rows 636 are opposite one another, thereby counteracting one another during inflation of the balloon 630. As a result, the net rotational force imparted by balloon 630 to a prosthetic valve during balloon inflation is zero and rotation of the prosthetic valve can be avoided.

[0400] FIG. 24 depicts a balloon 650 comprising a plurality of circumferentially extending rows 654 of zig-zagging pleats 652 (which can also be referred to as chevron shaped). The zig-zagging pleats 652 alternate with one another in adjacent rows such that a peak of a pleat in one row is aligned in an axial direction (which is parallel to a central longitudinal axis 655 of the balloon 650) with a valley of a pleat in an adjacent row. The rows 654 are arranged between a first end 656 and a second end 658 of the balloon 650.

[0401] The peaks of the zig-zagging pleats 652 are oriented in the axial direction. The pleats 652 can mimic the interconnected, angled struts of a stent or frame of a prosthetic valve (such as the frame 102). As a result, as the balloon 650 is inflated, the pleats 625 expand radially outward and allow the balloon 650 to radially expand without pleats that rotate around a longitudinal axis of the balloon.

[0402] In some examples, the inflatable balloon of the delivery apparatus can be at least partially covered with an elastic polymer sleeve (as shown in FIG. 25A) and / or a layer of lubricant (as shown in FIG. 25B), thereby separating a prosthetic valve arranged around the inflatable balloon from the balloon and preventing or at least minimizing rotation of the prosthetic valve during inflation of the balloon and deployment of the prosthetic valve.

[0403] For example, FIG. 25A depicts a sleeve 700 for the delivery apparatus 200. In some examples, the sleeve 700 comprises a polymer and can be referred to as a polymeric sleeve 700. The sleeve 700 is positioned around at least a portion of the inflatable body of the inflatable balloon 228. In some examples, the sleeve 700 is positioned over the inflatable body of the inflatable balloon 228, at an axial location where a prosthetic valve is positioned for radially expanding and deploying the prosthetic valve at an implantation site, and separates the prosthetic valve from the pleats of the balloon. In some examples, the sleeve 700 covers an entirety of the inflatable body of the inflatable balloon 228.

[0404] Although the sleeve 700 is depicted on the balloon 228 of the delivery apparatus 200, the sleeve 700 can be used on a variety of balloon catheters having an inflatable balloon for deploying a radially expandable device (for example, stents, prosthetic valves, or the like).

[0405] The sleeve 700 can comprise a polymer that is elastic and configured to stretch as the inflatable balloon 228 is inflated and expands, without hindering the expansion of the balloon 228.

[0406] The sleeve 700 can be configured such that it does not adhere to the outer surface of the inflatable balloon 228, and thus, as the balloon 228 inflates and rotates, the sleeve 700 does not rotate and remains stationary in the circumferential direction. As a result, a prosthetic valve or other device arranged around the sleeve 700 will not rotate during inflation of the balloon 228.

[0407] For example, the sleeve 700 can comprise an elastic and smooth polymer or have a non-stick coating or comprise a non-stick material at its inner surface (such as Teflon).

[0408] In some examples, the sleeve 700 can be a membrane extending over all or a portion of the balloon 228. For example, the membrane can be configured to space the prosthetic valve away from and keep the prosthetic valve from rotating relative to the balloon 228 as the balloon unfurls its pleats. As the balloon expands radially outward, the membrane can burst, break, or dissolve, thereby allowing the prosthetic valve to fully expand as the balloon inflates. For example, in some examples, most or all of the balloon rotation occurs in a first stage of balloon inflation (e.g., about the first 10% of balloon expansion), and little if any rotation occurs during a second stage of inflation (e.g., a remaining 90% of balloon inflation). In such examples, the sleeve 700 can remain intact during the first stage of inflation and prevent or minimize rotation of the prosthetic valve as the balloon pleats unfurl. The sleeve 700 can be configured to burst, break or dissolve at the end of the first stage of inflation. During the second stage of inflation, the prosthetic valve can be in contact with the balloon, but valve rotation is prevented or minimized because minimal or no balloon rotation occurs during this stage.

[0409] In some examples, instead of breaking, dissolving, or stretching, the sleeve 700 can be retracted (for example, via a pull wire or suture connected between the sleeve 700 and a handle of the delivery apparatus) so that the balloon can fully inflate to fully expand the prosthetic valve. For example, after a first stage of balloon inflation (for example, a first stage or inflation amount where pleats of the balloon unfurl or unfold), the sleeve 700 can be retracted, after which the balloon can continue to inflate and fully expand the prosthetic valve without resistance in a second stage of balloon inflation.

[0410] FIG. 25B depicts a lubricating coating 710 layered over the inflatable balloon 228. In some examples, the sleeve 700 of FIG. 25 A can be arranged over the lubricating coating 710, over the inflatable body of the inflatable balloon 228 (as shown by dashed lines in FIG. 25B). This further reduces the interaction between the inflatable balloon and the sleeve 700, thereby further ensuring that the sleeve 700 and a prosthetic valve arranged thereon do not rotate, even if the inflatable balloon rotates during inflation.

[0411] In some examples, the lubricating coating 710 comprises a lubricant such as silicone oil.

[0412] In some examples, as shown in FIG. 26 and 27, the delivery apparatus can include various devices or members (for example, mechanical devices or members) for holding the prosthetic valve in place on the inflatable balloon and preventing rotation of the prosthetic valve during inflation of the inflatable balloon.

[0413] FIG. 26 shows an example of a first holding device 800 (or member) and a second holding device 802 (or member) for the delivery apparatus 200 (or another prosthetic device delivery apparatus). In some examples, the delivery apparatus 200 can include both the first holding device 800 and the second holding device 802, as shown in FIG. 26. In some examples, the delivery apparatus 200 can include only one of the first holding device 800 or only the second holding device 802.

[0414] The first holding device 800 can extend from the distal tip, or nose cone 232, of the delivery apparatus 200 to a distal end of the prosthetic valve 100. In some examples, the first holding device 800 can couple to an outer surface of the prosthetic valve 100, such as with coupling portion 804 of the first holding device 800. In some examples, the first holding device 800 can comprise a narrower coupling portion that fits inside and couples to an interior of the prosthetic valve 100. In some examples, the coupling portion 804 can be attached to the apices or struts at the distal end of the prosthetic valve by fasteners, such a sutures or wires.

[0415] In some examples, the first holding device 800 is a relatively rigid component that is solid or comprises a rigid frame. In some examples, the first holding device 800 is radially expandable and collapsible.

[0416] In some examples, the first holding device 800 comprises a plurality of wires or sutures that extend between and couple to each of the nose cone 232 and the distal end of the prosthetic valve 100 (such as the struts or apices of the valve).

[0417] The wires or sutures can be pulled taught such that the prosthetic valve 100 is held stationary in the circumferential direction.

[0418] In some examples, the wires or sutures can be retractable.

[0419] The second holding device 802 can extend from the distal end 223 of the outer shaft 222 to the proximal end of the prosthetic valve 100. The second holding device 802 can couple to the proximal end of the prosthetic valve 100, such as to the struts or apices defining the proximal end of the prosthetic valve 100 (for example, by hooking or tying around the struts).

[0420] In some examples, the second holding device 802 can comprise a relatively rigid tube, an expandable and / or collapsable frame, one or more sutures, and / or one or more wires.

[0421] In some examples, the first holding device 800 and / or the second holding device 802 can be radially compressible (and expandable) such that after holding the prosthetic valve 100 during inflation of the balloon and radial expansion of the valve, they can be compressed and retracted back into a shaft of the delivery apparatus or a delivery sheath (for removing the delivery apparatus 200 from the body, through a patient’s vasculature).

[0422] In some examples, the first holding device 800 and / or the second holding device 802 can be used in combination with one or more of the balloon or sleeve embodiments described herein. For example, the first holding device 800 and / or the second holding device 802 can be used in combination with the sleeve 700 of FIGS. 25A and / or 25B.

[0423] FIG. 27 shows an example of expandable stents or frames arranged on both sides of the prosthetic valve 100, which is arranged around the inflatable balloon 228. For example, the expandable stents can include a first expandable frame 810 arranged around a distal end portion of the balloon 228 at a distal end of the prosthetic valve 100 and a second expandable frame 812 arranged around a proximal end portion of the inflatable balloon (and / or the crimp balloon) at a proximal end of the prosthetic valve 100.

[0424] The first expandable frame 810 and the second expandable frame 812 can each comprises a plurality of interconnected struts defining open cells of the frame. In some examples, the cells are diamond shaped.

[0425] The first expandable frame 810 and the second expandable frame 812 are configured to hold the prosthetic valve 100 in place, such that it does not rotate, as the inflatable balloon 228 inflates and the prosthetic valve radially expands. Said another way, even if the inflatable balloon 228 rotates as it inflates, the first expandable frame 810 and the secondexpandable frame 812 hold the prosthetic valve 100 in a stationary circumferential or rotational position as it radially expands.

[0426] The first expandable frame 810 can extend between a distal tip of the delivery apparatus (for example, the nose cone 232) and the distal end of the prosthetic valve 100. In some examples, the first expandable frame 810 can lock into the distal end of the prosthetic valve 100, such as extending inside the frame of the prosthetic valve 100 and / or coupling to apices or struts of the frame of the prosthetic valve 100.

[0427] The second expandable frame 812 can extend between a distal end of the balloon shaft 226 (or, in some examples, a different shaft of the delivery apparatus) and the proximal end of the prosthetic valve 100. In some examples, the second expandable frame 812 can lock into the proximal end of the prosthetic valve 100, such as extending inside the frame of the prosthetic valve 100 and / or coupling to apices or struts of the frame of the prosthetic valve 100.

[0428] The first expandable frame 810 and the second expandable frame 812 are configured to radially expand as the inflatable balloon 228 inflates and the prosthetic valve 100 radially expands, thereby allowing the first and second expandable frames 810, 812 to maintain contact with the prosthetic valve 100 and hold it rotationally in place throughout the radial expansion and deployment.

[0429] Prior to deployment of the prosthetic valve, the first expandable frame 810 and the second expandable frame 812 can be maintained in a radially collapsed configuration, thereby reducing push forces as the delivery apparatus is navigated through a patient’s vasculature.

[0430] FIGS. 41 and 42 depict an example of a holding device for a delivery apparatus that is configured to hold a proximal end of a prosthetic valve (or another prosthetic device, such as a stent) and prevent rotation of the prosthetic valve during at least a portion of inflation of the inflatable balloon of the delivery apparatus to radially expand the prosthetic valve. In the example of FIGS. 41 and 42, the holding device is a distal tip 1102 at a distal end of a shaft 1122 of a delivery apparatus 1100.

[0431] The delivery apparatus 1100 can be similar to the delivery apparatus 200. For example, an inner shaft 1134 of the delivery apparatus 1100 can be similar to the inner shaft 234 of the delivery apparatus 200, and the balloon shaft 1126 can be similar to the shaft 226 of the delivery apparatus 200. As described above for the delivery apparatus 200, the shaft1122 (which can be similar to the shaft 222) and the balloon shaft 1126 can be axially movable relative to one another. In this way, the distal tip 1102 can be used to move the prosthetic valve 100 onto the inflatable balloon 1128, as described further below. Although not shown, the delivery apparatus 1100 can include a crimp balloon (for example, crimp balloon 225) that extends from the proximal end of the inflatable balloon 1128 to the distal end of the balloon shaft 1126.

[0432] In some examples, the distal tip 1102 can be used in lieu of distal end 223 of the shaft 222 in the delivery apparatus 200.

[0433] In some examples, the distal tip 1102 can be configured to flex outward or compress inward in a radial direction, and thus can be referred to as a flex tip of the delivery apparatus 1100. For example, the distal tip 1102 can be configured to flex radially outward and receive at least a portion of the inflatable balloon 1128 of the delivery apparatus 1100 inside the distal tip 1102 when the distal tip 1102 is positioned over a proximal end portion of the balloon 1128, as shown in FIG. 41.

[0434] In some examples, as shown in FIG. 42, a distal end of the distal tip 1102 is configured to interface with a prosthetic device, such as the prosthetic valve 100, mounted on the delivery apparatus 1100. For example, the distal end 1106 can comprise mating features 1108 that are configured to mate with a proximal end of the prosthetic valve 100. In some examples, the mating feature 1108 can mate with struts or apices at the proximal end of the frame 102 of the prosthetic valve 100, as depicted in FIG. 42. For example, the mating features 1108 can comprise teeth, ridges, slots, or other indentations that are configured to receive apices or another portion of the prosthetic valve 100 therein. By having such mating features around a circumference of the distal tip 1102, the prosthetic valve coupled therein is prevented from rotating in the circumferential direction.

[0435] During an implantation procedure using the delivery apparatus 1100, in some examples, the prosthetic valve 100 can be initially crimped on the crimp balloon for insertion into the patient’s body and then advanced onto the inflatable balloon 1128, such as by advancing the shaft 1122 distally relative to the inner shaft 1134 and the balloon shaft 1126 and / or retracting the inner shaft 1134 and the balloon shaft 1126 proximally relative to the shaft 1122. As the shaft 1122 is advanced distally and / or the shafts 1126, 1134 are retracted proximally, the distal tip 1102 pushes against the prosthetic valve 100 to move it from itsinitial position (for example, on the crimp balloon) to a position around the inflatable balloon 1128.

[0436] In some examples, the prosthetic valve may be initially arranged around the inflatable balloon 1128.

[0437] Once the prosthetic valve 100 (or other prosthetic device) is arranged around the inflatable balloon 1128 (as shown in FIGS. 41 and 42), rotational alignment of the prosthetic valve 100 relative to the implantation site (for example, the native valve) can be performed by rotating the balloon shaft 1126 and the inner shaft 1134 about a central longitudinal axis 1105 of the delivery apparatus 1100, which thereby rotates the balloon 1128 and the prosthetic valve 100 mounted thereon.

[0438] When the prosthetic valve 100 is arranged around the inflatable balloon 1128, the distal tip 1102 can already be in or be moved into mating contact with the prosthetic valve 100 (for example, by translating the outer shaft 1122 relative to the balloon shaft 1126), as shown in FIG. 42. During an initial, or first, stage of inflation of the inflatable balloon, the distal tip 1102 holds the prosthetic valve 100 in place over the inflatable balloon 1128, thereby preventing rotation of the prosthetic valve 100 as the pleats of the inflatable balloon 1128 unfurl and inflate a first amount (for example, about 10% of the total inflation volume). Once the pleats of the inflatable balloon 1128 have unfolded or unfurled, the distal tip 1102 can be retracted away from the prosthetic valve 100. In some examples, the distal tip 1102 can expand radially and increase in diameter under pressure from the expanding balloon at least during the first inflation stage. Inflation of the inflatable balloon 1128 can then continue as a second stage of inflation until the prosthetic valve 100 is fully expanded and deployed at the implantation site. Since the balloon pleats have already unfurled prior to retracting the distal tip 1102, the prosthetic valve does not rotate during the second stage of inflation of the inflatable balloon 1128.

[0439] It should be noted that the distal tip 1102 described herein with reference to FIGS. 41 and 42 can be combined with any of the other examples described herein. For example, the distal tip 1102 can be combined with any of the balloon examples described herein and / or the polymeric sleeve 700.

[0440] FIGS. 43 and 44 depict an exemplary delivery apparatus 1200 comprising a protrusion 1204 that is configured to partially radially expand the prosthetic valve as the prosthetic valve is moved axially over the protrusion 1204 and onto the inflatable balloon1228 (for example, from its position around the crimp balloon 1225, as shown in FIG. 43, to a position around the inflatable balloon 1228, as shown in FIG. 44).

[0441] The delivery apparatus 1200 can be similar to the delivery apparatus 200. For example, an inner shaft 1234 of the delivery apparatus 1200 can be similar to the inner shaft 234 of the delivery apparatus 200, and the balloon shaft 1226 can be similar to the shaft 226 of the delivery apparatus 200. As described above for the delivery apparatus 200, the outer shaft 1222 (which can be similar to the shaft 222) and the balloon shaft 1226 can be axially movable relative to one another. In this way, the distal tip 1202 (or distal end of the outer shaft 1222) can be used to move the prosthetic valve 100 onto the inflatable balloon 1228, as described further below. As shown in FIGS. 43 and 44, the delivery apparatus 1200 can also include a crimp balloon 1225 that extends from the proximal end of the inflatable balloon 1228 to the distal end of the balloon shaft 1226.

[0442] As shown in FIG. 43, the prosthetic valve 100 can be initially mounted around the crimp balloon 1225, proximal to the inflatable balloon 1228. A portion of the delivery apparatus 1200 between where the prosthetic valve 100 is mounted around the crimp balloon 1225 and the body portion of the inflatable balloon 1228 can comprise a protrusion 1204 that protrudes radially outward relative to a central longitudinal axis 1205 of the delivery apparatus 1200.

[0443] For example, as shown in FIGS. 43 and 44, the protrusion 1204 can be part of the inner shaft 1234 or be coupled to an outer surface of the inner shaft 1234. As a result, the protrusion 1204 protrudes radially outward from a shaft portion of the inner shaft 1234.Thus, a diameter of the protrusion is larger than a diameter of the shaft portion of the inner shaft 1234.

[0444] In some examples, the protrusion 1204 may instead be part of or coupled to a proximal leg of the inflatable balloon 1228.

[0445] In some examples, the protrusion 1204 may instead be part of or coupled to a distal end portion of the crimp balloon 1225.

[0446] An outer diameter of the protrusion 1204 is larger than an inner diameter of the prosthetic valve 100 in its radially compressed configuration around the crimp balloon 1225.

[0447] During an implantation procedure, after the prosthetic valve 100 is advanced through the narrowest portions of the patient’s vasculature, the prosthetic valve 100 can be moved onto the inflatable balloon 1228. As introduced herein with reference to the deliveryapparatus 200, the prosthetic valve 100 can be moved onto the inflatable balloon 1228, for example, by moving the balloon shaft 1226 and the inner shaft 1234 in the proximal direction relative to the outer shaft 1222. As the balloon shaft 1226 and the inner shaft 1234 are moved in the proximal direction, the distal tip 1202 of the outer shaft 1222 pushes against the prosthetic valve 100, allowing the inflatable balloon 1228 to be moved proximally through the prosthetic valve 100 to center the prosthetic valve 100 on the balloon 1228, as shown in FIG. 44. In lieu of or in addition to moving the balloon shaft 1226, the inner shaft 1234, and the inflatable balloon 1228 proximally relative to the outer shaft 1222, repositioning of the prosthetic valve 100 can be accomplished by moving the outer shaft 1222 distally relative to the balloon shaft 1226, the inner shaft 1234, and the balloon 1228.

[0448] When the prosthetic valve 100 is initially crimped on the crimp balloon 1225, the prosthetic valve 100 frictionally engages the crimp balloon by virtue of the radial crimping force of the prosthetic valve against the crimp balloon. As the prosthetic valve 100 is moved axially onto the inflatable balloon 1228, the protrusion 1204 encounters a distal end of the prosthetic valve 100 and causes the prosthetic valve 100 to partially radially expand (or increase in diameter) as the protrusion 1204 moves through the prosthetic valve 100 (or the prosthetic valve moves over the protrusion 1204). As shown in FIG. 44, after passing over the protrusion 1204 and onto the inflatable balloon 1228, the prosthetic valve 100 has a larger diameter than its original diameter when mounted around the crimp balloon 1225.

[0449] Thus, as shown in FIG. 44, after repositioning the prosthetic valve 100 around the inflatable balloon 1228, in some examples, there can be a gap 1230 between the body portion of the inflatable balloon 1228 and the interior of the prosthetic valve 100. In some examples, there may not necessarily be a gap between the outer surface of the balloon 1228 and the valve components (e.g., the leaflets 112) inside of the frame 102 of the prosthetic valve 100, but the prosthetic valve 100 is radially expanded by the protrusion 1204 to such an extent that there is minimal, if any, frictional engagement between the prosthetic valve and the balloon 1228. In other words, once the prosthetic valve is partially expanded by the protrusion, the soft components inside the frame of the prosthetic (e.g., the leaflets) may contact the balloon 1228 but not exert a gripping force against the balloon 1228. Thus, the protrusion 1204 serves to partially radially expand the prosthetic valve to remove or substantially reduce the frictionally engagement between the prosthetic valve and the balloon 1228.

[0450] The delivery apparatus 1200 can be advanced to position the prosthetic valve 100 near the intended implantation site and rotated to achieve a desired rotational alignment of the prosthetic valve relative to the native anatomy. After the prosthetic valve 100 is positioned at the implantation site, the inflatable balloon 1228 can be inflated to radially expand and deploy the prosthetic valve 100. However, since the prosthetic valve 100 no longer frictionally engages the inflatable balloon 1228, during an initial stage of balloon expansion when the pleats of the inflatable balloon 1228 unfurl (or unfold), the prosthetic valve 100 does not rotate. After the pleats unfurl, the balloon 1228 begins to expand radially outward and eventually fills the gap 1230 and contacts the prosthetic valve 100. As a result, the prosthetic valve 100 radially expands along with the balloon, without rotating relative to its starting position. Thus, the prosthetic valve 100 is implanted at the native anatomy in the target rotational position relative to the native anatomy.

[0451] FIGS. 45A-53B depict examples of multi-part balloon assemblies (which may also be referred to as a composite balloons) comprising two or more separate balloons or balloon portions that can be incorporated into a medical device, such as the delivery apparatus 200. For example, instead of a single balloon formed by blow molding a cylindrical parison, the multi-part balloon can comprise two or more individual balloons or balloon portions, each formed such as by blow molding a parison (e.g., a cylindrical parison) within a mold having a shape of a section of a full cylinder (for example, a half cylinder, 1 / 3 cylinder, ¼ cylinder, and / or the like) to form a balloon having the same shape of the mold. The individual, partial-cylindrical balloons are then joined or otherwise coupled together to form a cylindrical (or approximately cylindrical) balloon assembly with two or more balloons. In some examples, the two or more balloons that form the balloon assembly can be fluidly separated from one another.

[0452] As used herein, when referring to two or more balloons of the same multi-part balloon assembly being “fluidly separated” from one another, this refers to their internal volumes or cavities being fluidly separated. Thus, when being filled with inflation fluid, fluid from one balloon does not pass into an adjacent balloon.

[0453] The multiple individual balloons within the same multi-part balloon assembly can be configured to resist and / or counteract each other’s tendency to rotate a prosthetic device mounted thereon due to unfolding of their pleats (for example, if the pleats of two or more balloons in the same balloon assembly are folded in opposite directions, they will unfurl inopposite directions and counteract each other’s tendency to rotate). Additionally and / or alternatively, the pleats of each individual balloon can be shaped and folded such that the pleats expand directly radially outward during inflation instead of unfurling or unfolding around a central longitudinal axis of the balloon assembly. Additionally, by utilizing multiple, partial-cylinder balloons within one multi-part balloon assembly, each balloon can be pleated and folded more easily. Moreover, multiple partial-cylinder balloons may be less likely to rotate from unfurling due to folding errors and / or spring back forces that may occur for a full cylinder, single-part balloon.

[0454] As also described further below, since each individual balloon is smaller than a full cylinder, and thus has a smaller inflation volume as compared to a conventional, fully cylindrical balloon, each individual balloon can have a reduced wall thickness while still maintaining its desired burst strength. As a result, the multi-part balloon assembly may be easier to retrieve and remove from the body (for example, due to its balloons being softer or less rigid).

[0455] Turning first to FIGS. 45A-48A, a first multi -part balloon assembly 1300 comprising two individual balloons 1302 and 1304 is depicted. FIG. 45 A shows an exploded view of the multi -part balloon assembly 1300 and FIGS. 45B and 46 show assembled views of the multipart balloon assembly 1300. In this example, the first balloon 1302 and the second balloon 1304 can each be formed by blow molding a half cylindrical (or approximately half cylindrical) parison or blow molding a cylindrical parison within a mold having a half cylinder shape. Each balloon can comprise a polymer used in medical balloons, such as Nylon, PET, Pebax, and / or the like.

[0456] As shown in the exploded view of FIG. 45A and the partially transparent view of FIG.46 (where internal, hidden lines are depicted by dashed lines), each of the first balloon 1302 and the second balloon 1304 comprises a respective mating surface 1306 and 1308 with a partial channel 1310 and 1312 (which can be half cylindrical channels), respectively, depressed therein and extending along a central longitudinal axis 1314 of the multi -part balloon assembly 1300. Each balloon 1302, 1304 has an outer surface 1303, 1305, respectively (as indicated in FIG. 46).

[0457] When the first mating surface 1306 of the first balloon 1302 mates with (for example, is in face-to-face contact with) the second mating surface 1308 of the second balloon 1304, the first half-cylindrical channel 1310 and the second half-cylindrical channel 1312 form acomplete channel 1316 (or lumen, which can be referred to as the central channel 1316) configured to receive the inner shaft of a delivery apparatus (for example, the inner shaft 234 of delivery apparatus 200).

[0458] In some examples, the first partial channel 1310 and the second partial channel 1312 may not be shaped as complete half-cylinders and instead may be formed by non-rounded walls, thereby defining a half square, hexagonal, or other polygonal shape.

[0459] Walls of the first balloon 1302 define a first internal volume of the first balloon portion 1302 and walls of the second balloon 1304 define a second internal volume of the second balloon portion 1304, wherein the first internal volume (or cavity) and the second internal volume (or cavity) can be fluidly separate from one another. Each balloon 1302, 1304 can be fluidly connected to a source of an inflation fluid, which can be, for example, connected to the proximal portion 224 of the delivery apparatus 200. As noted above, the delivery apparatus 200 can have a fluid path defined between the inner shaft 234 and the balloon shaft 226. The distal end of the fluid path can be in fluid communication with the internal cavities of each balloon for delivering the inflation fluid into each balloon. In some examples, a delivery apparatus can include fluidly separate lumens, each of which is configured to deliver an inflation fluid from the inflation fluid source to a respective balloon. For example, the fluid path defined between the inner shaft 234 and the balloon shaft 226 can include partitions or walls that divide the fluid path into multiple fluid paths.

[0460] In some examples, the first balloon 1302 and the second balloon 1304 can be connected to each other, for example, at their respective mating surfaces 1306 and 1308, such as by welding surfaces 1306 and 1308 to each other, bonding mating surfaces 1306 and 1308 with an adhesive, and / or chemically bonding or fusing the mating surfaces 1306 and 1308 to each other.

[0461] In some examples, the first balloon 1302 and the second balloon 1304 can be mechanically coupled together (in lieu of or in addition to welding, adhesive bonding or chemical bonding or fusing), such as via pre-formed grooves and protrusions on the respective mating surfaces 1306 and 1308 that are configured to fit together (for example, snap or slide fit together such as a groove fitting within a channel).

[0462] In some examples, the balloons 1302, 1304 can be in fluid communication with each other; that is, they are not fluidly separate. For example, the mating surfaces 1306, 1308 caninclude corresponding openings or apertures that are aligned with each other and allow an inflation fluid to pass from one ballon to another balloon.

[0463] In some examples, the balloons 1302, 1304 are not fixed or connected to each other but can engage each other at the respective mating surfaces.

[0464] The central channel 1316 can be reinforced with a metal or polymeric material or reinforcing member, in some examples. For example, a metal or polymeric tube can be fit within at least a portion of the channel 1316. In some examples, the reinforcing member can be porous or have a discontinuous supporting wall design such as a combination of one or more supporting wires, a stent structure, a coil spring, or the like.

[0465] FIG. 47 depicts an exemplary reinforcing member 1318 within the central channel 1316. As shown in FIG. 47, the reinforcing member 1318 can be a metal or polymeric coil that contacts the walls of the first and second half-cylindrical channels 1310 and 1312 while maintaining an open central channel for passage of the inner shaft of the delivery apparatus (for example, the inner shaft 234 of the delivery apparatus 200).

[0466] In the illustrated example, when assembled together, the outer surfaces 1303, 1305 together define an outer surface of the balloon assembly 1300 that has a circular cross-sectional profile in a plane perpendicular to the central longitudinal axis 1314. Similarly, when the balloons 1302, 1304 are assembled together, the balloon assembly 1300 has a full cylinder shape.

[0467] In some examples, the balloon assembly 1300 (or similar balloon assemblies) can comprises more than two balloons. For example, FIGS. 48A-48D depict end views of balloon assemblies having different numbers of balloons. FIG. 48A depicts the balloon 1300 with two balloons 1302 and 1304 that are each approximately half of a whole cylinder (as also depicted in FIGS. 45A-46). FIG. 48B depicts a balloon assembly 1320 with three balloons 1322, 1324, and 1326 that are each approximately one-third of a whole cylinder. FIG. 48C depicts a balloon assembly 1330 with four balloons 1332, 1334, and 1336, and 1338 that are each approximately one-fourth of a whole cylinder. FIG. 48D depicts a balloon assembly 1340 with five balloons 1342, 1344, 1346, 1348, and 1350 that are each approximately one-fifth of a whole cylinder. In this way, a multi-part balloon assembly can have different numbers of balloons, each of which comprises a mating surface (with one or more mating surface portions) with a depression that forms a part of the central channel 1316 of the balloon assembly.

[0468] For example, the first balloon 1322 of the balloon assembly 1320 (FIG. 48B) may have a first mating surface portion that mates with a respective mating surface portion of the second balloon 1324, and a second mating surface portion that mates with a respective mating surface portion of the third balloon 1326. Thus, each balloon 1322, 1324, 1326 has first and second mating surface portions, each of which mates with adjacent mating surface portion of an adjacent balloon. Each balloon 1322, 1324, 1326 can further include a depression 1328 (e.g., a partial cylindrical depression) extending between the inner ends of the mating surface portions. The depressions 1328 of the balloons collectively form the channel 1316.

[0469] A reinforcing member 1318 can be positioned inside the central channel 1316 of any of the balloon assemblies shown in FIGS. 48A-48D. However, in some examples, any of these balloon assemblies may not include a reinforcing element, or the reinforcing element may only extend along a portion of the central channel 1316.

[0470] In some examples, the reinforcing element can be discontinuous along the central channel 1316, such that one or more sections of the central channel 1316 may not include the reinforcing element.

[0471] Multi-part balloon assemblies, such as any one of the multi-part balloon assemblies 1300, 1320, 1330, and 1340, can be pleated and folded such that the balloon assembly unfolds and radially expands during inflation without rotating a prosthetic device mounted thereon (or such that a final rotational position of the radially expanded prosthetic device after inflation is the same as its initial rotational position prior to inflation). For example, each balloon of the multi-part balloon assembly can be pleated and folded such that each pleat of the balloon unfolds radially outwardly without unfolding and spiraling around the central longitudinal axis of the balloon assembly. Additionally and / or alternatively, each balloon of the multi-part balloon assembly can be pleated and folded such that each pleat of a first balloon unfolds in a circumferential direction that counteracts the unfolding in an opposite circumferential direction of a corresponding pleat of a second balloon of the multipart balloon assembly. Each individual balloon of any multi-part balloon assembly disclosed herein can be folded according to any of the techniques and shapes described herein for a single balloon (e.g., such as the examples shown in FIGS. 12-24, 31, 34, 35, 37, 40, and / or the like).

[0472] As an example, a cross-sectional view of the first balloon 1302 of the balloon assembly 1300 is shown in FIG. 49. For purposes of illustration, dashed lines are added to define three sections 1352 (or wedges) of the first balloon 1302. Each section 1352 is pleated and folded radially inward toward a central longitudinal axis of the balloon assembly to form a pleat 1354, as depicted in FIG. 50. In the example of FIGS 49 and 50, the first balloon 1302 is pleated and folded into three pleats 1354. In some examples, the pleats 1354 comprise box pleats.

[0473] The second balloon 1304 can be similarly pleated and folded into three pleats 1354. Thus, the multi-part balloon assembly 1300 comprises six pleats 1354 in total. However, since the internal volumes of the first balloon 1302 and second balloon 1304 are fluidly separate, the three pleats of the first balloon 1302 radially expand separately from the three pleats of the second balloon 1304 during inflation. Said another way, the three pleats of the first balloon 1302 are decoupled from the three pleats of the second balloon 1304, and thus the unfolding and expansion of the pleats of the first balloon 1302 does not influence the unfolding and expansion of the pleats of the second balloon 1304 (and vice versa).

[0474] Each balloon can be pleated and folded into more or less than three pleats (such as two, four, five, six, or the like).

[0475] In some examples, each balloon of a multi-part balloon assembly is pleated into an equal number of pleats. As a result, unfolding of the pleats of each balloon during balloon inflation can counteract one another such that a prosthetic device mounted thereon is not rotated in its final radially expanded configuration relative to is radially compressed configuration prior to balloon inflation.

[0476] FIGS. 51A-52 depict an example of pleating and folding the first balloon 1302 into four pleats 1354. As shown in FIG. 51 A, the first balloon 1302 (and similarly the second balloon 1304) can be divided into four sections 1352a, 1352b, 1352c, 1352d which are continuous with one another but each pleated and folded into a respective pleat 1354a, 1354b, 1354c, and 1354d (as shown in the side view of FIG. 52). In some examples, the pleats 1354a-d comprise box pleats.

[0477] For example, FIG. 51B shows an example of folding the sections 1352a-d into pleats 1354a-d by depressing radially inward along fold lines 1360a-c to create four pleats 1354a-d. As noted above, the first balloon 1302 can be pleated and folded in various ways, such as any of the pleating and folding patterns and methods described herein.

[0478] As a result of the pleating and folding, the first balloon 1302 (and the second balloon 1304) has four pleats 1354a, 1354b, 1354c, and 1354d that are continuous with one another, as shown in FIG. 52.

[0479] FIGS. 53 A and 53B depict an example of pleating and folding the first balloon 1302 into six pleats 1354. The first balloon 1302 (and similarly the second balloon 1304) can be divided into six sections, similar to the four sections of FIGS. 49 and 51 A. Each section is pleated and folded into a respective pleat 1354, similar to that described above for FIGS. 51A-52. FIG. 53A shows a side view of a portion of the first balloon 1302 in a radially compressed and deflated configuration. FIG. 53B shows a side view of the portion of the first balloon 1302 in a at least partially inflated configuration. As shown in FIG. 53B, as the first balloon 1302 inflates, the pleats 1354 unfold and expand in a radial outward direction. This may reduce and / or prevent a prosthetic device mounted thereon from rotating relative to its rotational position prior to inflating the balloon.

[0480] Although the different pleating examples described herein with reference to FIGS. 49-53B are described for a half-circular balloon (for a balloon comprising two balloons), the different pleating arrangements can be applied to balloons having 1 / 3 circular shapes, ¼ circular shapes, 1 / 5 circular shapes, and / or the like. For example, the described pleating arrangements can be applied to any of the multi -part balloon assemblies depicted in FIGS. 48A-48D.

[0481] In some examples, all the balloons of a multi-part balloon assembly can be inflated simultaneously when inflating the multi-part balloon assembly to radially expand a prosthetic device mounted thereon. For example, simultaneously inflating the balloons of the balloon assembly 1300 may include flowing inflation fluid to both the first balloon 1302 and the second balloon 1304 at the same time.

[0482] In some examples, each or two or more of the balloons of the multi -part balloon assembly can be inflated separately or in stages relative to one another when the balloons are fluidly separated from each other. For example, inflation of the balloon assembly 1300 can include inflating the first balloon 1302 first, and then inflating the second balloon 1304 during or after inflating the first balloon 1302.

[0483] In some examples, one or more partitions or valves may be included in a lumen between the inner shaft and balloon shaft of the delivery apparatus to fluidly separate thefluid paths to the individual balloons of the multi-part balloon assembly. In this way, inflation fluid can be delivered separately to the multiple balloon portions.

[0484] The multi-part balloon assemblies described herein can increase accuracy of deploying a prosthetic device in a target rotational alignment due to the pleats of the multiple balloons of the multi -part balloon assembly resisting or counteracting each other's tendency to rotate a prosthetic device mounted thereon due to unfolding of the pleats. As noted above, each balloon of a multi-balloon assembly can be pleated in the manner shown and described herein for any of the full cylinder single balloons. For example, the pleats of one balloon of a multi -balloon assembly can be pleated in opposite directions (e.g., such as shown in FIGS.14A, 15A, 16, 22A, 22B, 23, 24, or 55C) and / or the pleats of different balloons of a multiballoon assembly can be pleated in opposite directions (e.g., such as shown in FIGS. 14A, 15A, 16, 22A, 22B, 23, 24, or 55C). The multi-balloon assembly can avoid valve rotation due to the pleats being folded in opposite directions. In some examples, the pleats of each individual balloon can be shaped and folded such that the pleats expand radially outward during inflation instead of unfolding around an axis of the balloon, thereby preventing a prosthetic valve mounted thereon from being rotated between its pre- and post-inflation positions (e.g., such as shown in FIGS. 12, 13A, 13B, 17, 18A, 18B, 21, 30, 31, 34, 39, 40, or 5 IB). In some examples, different folding techniques can be used for different balloons of the same multi-balloon assembly. For example, one balloon of a multi-balloon assembly can be pleated in opposite directions (e.g., such as shown in FIGS. 14A, 15A, 16, 22A, 22B, 23, 24, or 55C), while another balloon can have pleats that expand outwardly (e.g., such as shown in FIGS. 12, 13A, 13B, 17, 18A, 18B, 21, 30, 31, 34, 39, 40, or 51B). A multi-balloon assembly may further resist valve rotation by mitigating spring back forces of the pleated balloon assembly. Further, by utilizing multiple balloons that are each smaller than a full cylinder (for example, 2, 1 / 3, or ( of a full cylinder), and thus have a smaller inflation volume as compared to a full cylinder balloon, each individual balloon can have a reduced wall thickness while still maintaining its burst strength. The thinner individual balloons can be easier to retrieve and remove from the body (for example, due to them being softer or less rigid).

[0485] As described herein, by employing an inflatable balloon, sleeves, holding members, and / or protrusions on a delivery apparatus that result in no rotation of the prosthetic device between it radially collapsed configuration (pre-balloon inflation) and radially expandedconfiguration (post-balloon inflation), the prosthetic device can be more easily and accurately positioned at an implantation site (for example, in a specified rotational or circumferential position relative to the native anatomy at the implantation site). In such systems, one or more radiopaque markers on the prosthetic device, such as markers at the commissures of a prosthetic valve, can be used to rotationally align the prosthetic valve relative to the native anatomy. This eliminates the need to rotationally offset a commissure of the prosthetic valve from a radiopaque marker on the delivery apparatus to account for balloon unfurling that causes valve rotation during deployment. As a result, special accessories and procedures for mounting the prosthetic valve on the delivery apparatus in a specified rotational orientation are not needed, thereby saving time and costs prior to and / or during an implantation procedure. During an implantation procedure, the prosthetic valve, while still in a radially compressed state on the delivery apparatus (on or adjacent a balloon) can be rotated relative to the native anatomy and positioned in a desired orientation, such as by aligning radiopaque markers on the prosthetic valve (e.g., markers 170) with anatomical landmarks (e.g., the native commissures). After rotationally aligning the prosthetic valve, the balloon can be inflated to radially expand the prosthetic valve against the native anatomy. By preventing rotation of the prosthetic valve during balloon expansion as described herein, the prosthetic valve can maintain the desired rotational alignment post inflation.Deli very Tech niq ues

[0486] 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 (e.g.. 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). Additionally and / or 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 info 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 aorticvalve. Additionally and / or alternatively, in a transaortic procedure, a prosthetic valve (on thedistal 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.

[0487] 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 deli ery 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. Additionally and / or 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,

[0488] 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 val ve / pulmonaty artery.

[0489] 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 trans ventricular 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 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.

[0490] 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.

[0491] 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.Simulation

[0492] The treatment techniques, methods, steps, etc. described or suggested herein or in references incorporated herein can be performed on a living animal or on a non-living simulation, such as on a cadaver, cadaver heart, anthropomorphic ghost, simulator (e.g., with the body parts, tissue, etc. being simulated), etc.Additional Examples of the Disclosed Technology

[0493] 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.

[0494] Example 1. A delivery apparatus comprising a handle; a shaft extending distally from the handle; and an inflatable balloon arranged around a distal end portion of the shaft and configured to inflate from a deflated state to an inflated state, wherein in the deflated state the inflatable balloon comprises a central cavity surrounding the shaft and a plurality of pleats, wherein each pleat of the plurality of pleats is folded such that when the balloon inflates, the pleats expand away from the shaft in a radially outward direction and unfold without rotating an implant mounted on the balloon relative to the shaft.

[0495] Example 2. The delivery apparatus of any example herein, particularly example 1, wherein each pleat has a T-shape in the deflated state of the inflatable balloon, wherein a stem of the T branches off the central cavity and a top of the T is spaced radially from the central cavity and extends in a circumferential direction.

[0496] Example 3. The delivery apparatus of any example herein, particularly example 1, wherein the plurality of pleats is arranged into a plurality of sub-groups of stacked pleats that zigzag across one another and stack in a radial direction, and wherein each sub-group is connected to an adjacent sub-group by a radially outward-most pleat that extends circumferentially across both sub-groups, thereby forming a group of two sub-groups.

[0497] Example 4. The delivery apparatus of any example herein, particularly example 3, wherein each sub-group of a first group is connected to an adjacent sub-group of a second group by a radially inward-most pleat that extends circumferentially across the sub-group of the first group and the sub-group of the second group.

[0498] Example 5. The delivery apparatus of any example herein, particularly example 1, wherein each pleat forms a spiral that extends radially outward from the central cavity and spirals in a circumferential direction back toward the central cavity, about an axis that is parallel to but radially spaced from a central longitudinal axis of the balloon.

[0499] Example 6. The delivery apparatus of any example herein, particularly example 5, wherein the plurality of pleats includes a first group of first pleats that spiral in a first direction and a second group of second pleats that spiral in a second direction that is opposite the first direction, and wherein there are an equal number of first pleats and second pleats.

[0500] Example 7. The delivery apparatus of any example herein, particularly example 6, wherein each first pleat is disposed adjacent to a respective second pleat.

[0501] Example 8. The delivery apparatus of any example herein, particularly example 1, wherein the plurality of pleats includes a first group of first pleats that curve around the central cavity in a first direction and a second group of pleats that curve around the central cavity in an opposite, second direction.

[0502] Example 9. The delivery apparatus of any example herein, particularly example 8, wherein there are an equal number of first pleats and second pleats.

[0503] Example 10. The delivery apparatus of any example herein, particularly example 1, wherein the plurality of pleats is spaced circumferentially apart from one another around thecentral cavity, and wherein each pleat is folded over itself a plurality of times to form a stack of zig-zagging folds that extends radially away from the central cavity.

[0504] Example 11. The delivery apparatus of any example herein, particularly example 1, wherein each pleat of the plurality of pleats does not have a directional bias in a circumferential direction that is relative to a central longitudinal axis of the delivery apparatus.

[0505] Example 12. The delivery apparatus of any example herein, particularly either example 1 or example 11, wherein the plurality of pleats includes a plurality of rhomboidshaped pleats grouped into axially extending rows of the rhomboid-shaped pleats that form an arrow-shaped pattern.

[0506] Example 13. The delivery apparatus of any example herein, particularly either example 1 or example 11, wherein each pleat of the plurality of pleats is hexagonal shaped with its longest dimension extending in a direction of the central longitudinal axis of the balloon.

[0507] Example 14. The delivery apparatus of any example herein, particularly either example 1 or example 11, wherein the plurality of pleats is arranged into a plurality of circumferentially extending rows of angled pleats, wherein a first group of first rows of the plurality of rows comprise pleats angling in a first direction around the balloon, relative to the central longitudinal axis of the balloon, and a group of second rows of the plurality of rows comprise pleats angling in a second direction around the balloon.

[0508] Example 15. The delivery apparatus of any example herein, particularly example 14, wherein the first rows and second rows alternate with one another, in a direction of the central longitudinal axis, from a first end to a second end of the balloon.

[0509] Example 16. The delivery apparatus of any example herein, particularly either example 1 or example 11, wherein the plurality of pleats is arranged into a plurality of circumferentially extending rows of zig-zagging pleats, and wherein the zig-zagging pleats alternate with one another in adjacent rows such that a peak of a pleat in one row is aligned in an axial direction with a valley of a pleat in an adjacent row.

[0510] Example 17. The delivery apparatus of any example herein, particularly example 16, wherein the plurality of circumferentially extending rows is arranged between a first end and second end of the balloon, and wherein the peaks of the zig-zagging pleats are oriented in the axial direction.

[0511] Example 18. The delivery apparatus of any example herein, particularly example 1, wherein the inflatable balloon comprises at least two balloons coupled together at respective mating surfaces and defining a central channel therebetween, wherein the shaft extends through the central channel, and wherein the at least two balloons are fluidly separate from one another.

[0512] Example 19. The delivery apparatus of any example herein, particularly any one of examples 1-18, wherein the shaft is a first shaft, and further comprising a rotatable second shaft extending distally from the handle, wherein the first shaft extends through the second shaft, and wherein the distal end portion of the first shaft extends distally beyond the first shaft.

[0513] Example 20. The delivery apparatus of any example herein, particularly example 19, wherein a proximal end portion of the inflatable balloon is coupled to the second shaft.

[0514] Example 21. The delivery apparatus of any example herein, particularly either example 19 or example 20, further comprising a third shaft, wherein the first and second shafts extend through the third shaft, and wherein the third shaft comprises a distal tip with mating features that are configured to couple to the implant.

[0515] Example 22. The delivery apparatus of any example herein, particularly example 21, wherein the mating features comprise a plurality of teeth.

[0516] Example 23. The delivery apparatus of any example herein, particularly any one of examples 1-22, further comprising a protrusion disposed proximal to a body portion of the inflatable balloon, wherein the protrusion extends radially outward relative to a central longitudinal axis of the delivery apparatus, and wherein a portion of the delivery apparatus disposed proximal to the protrusion is configured to receive the implant mounted thereon in a radially collapsed configuration.

[0517] Example 24. The delivery apparatus of any example herein, particularly example 23, wherein the protrusion is on the shaft.

[0518] Example 25. An assembly comprising the delivery apparatus of any example herein, particularly any one of examples 1-24, and further comprising a prosthetic valve mounted on a distal end portion of the delivery apparatus in a radially collapsed configuration, wherein the balloon is configured to radially expand the prosthetic valve as it inflates, and wherein the prosthetic valve is configured to radially expand such that a rotational position of the prosthetic valve relative to the shaft when the balloon is in the inflated state is the same as arotational position of the prosthetic valve relative to the shaft when the balloon is the deflated state.

[0519] Example 26. A method comprising arranging a prosthetic device, in a radially collapsed configuration, around a balloon of a delivery apparatus, wherein the balloon comprises a plurality of pleats that are folded around a central longitudinal axis of the balloon, wherein the balloon is in a compressed and deflated configuration; and inflating the balloon to radially expand the prosthetic device such that a rotational position of the prosthetic device after the inflating is the same as a rotational position of the prosthetic device before the inflating.

[0520] Example 27. The method of any example herein, particularly example 26, further comprising, prior to inflating the balloon, delivering the prosthetic device to an implantation site and rotating the prosthetic device into a specified rotational position relative to the implantation site.

[0521] Example 28. The method of any example herein, particularly either example 26 or example 27, wherein the plurality of pleats is folded against one another such that they curve around a central cavity of the balloon in a first circumferential direction.

[0522] Example 29. The method of any example herein, particularly example 28, wherein a distal leg of the balloon is circumferentially offset from a proximal leg of the balloon in a second circumferential direction that is opposite the first circumferential direction.

[0523] Example 30. The method of any example herein, particularly example 28, wherein a polymeric sleeve is arranged around at least a portion of the balloon, and wherein arranging the prosthetic device in the radially collapsed configuration around the balloon includes arranging the prosthetic device around the polymeric sleeve such that the polymeric sleeve separates the prosthetic device from the balloon.

[0524] Example 31. The method of any example herein, particularly example 30, further comprising applying a lubricating coating over at least the portion of the balloon and arranging the polymeric sleeve over the lubricating coating.

[0525] Example 32. The method of any example herein, particularly example 30, wherein the sleeve is configured to break or dissolve as the balloon is inflated and expands radially outward.

[0526] Example 33. The method of any example herein, particularly any one of examples 26-32, further comprising, prior to inflating the balloon, coupling one or more holdingdevices that are attached to the delivery apparatus to one or more ends of the prosthetic device, and wherein the one or more holding devices is configured to maintain a rotational position of the prosthetic device on the delivery apparatus during inflating the balloon and radially expanding the prosthetic device, even if the balloon rotates.

[0527] Example 34. The method of any example herein, particularly example 33, wherein the balloon is mounted around a first shaft of the delivery apparatus, wherein the one or more holding devices includes a flex tip positioned at a distal end portion of a second shaft of the delivery apparatus, wherein the flex tip is configured to couple to a proximal end of the prosthetic device to prevent rotation of the prosthetic device, and wherein the first shaft extends through and distally beyond the second shaft.

[0528] Example 35. The method of any example herein, particularly either example 33 or example 34, wherein the one or more holding devices includes a first holding device that extends from a distal tip of the delivery apparatus to a proximal end of the prosthetic device.

[0529] Example 36. The method of any example herein, particularly any one of examples 33-35, wherein the balloon is mounted around a first shaft of the delivery apparatus, wherein the one or more holding devices includes a second holding device that extends from a distal end of a second shaft of the delivery apparatus to a proximal end of the prosthetic device, and wherein the first shaft extends through and distally beyond the second shaft.

[0530] Example 37. The method of any example herein, particularly any one of examples 33-36, wherein the one or more holding devices includes an expandable frame.

[0531] Example 38. The method of any example herein, particularly any one of examples 33-36, wherein the one or more holding devices includes one or more wires or sutures.

[0532] Example 39. The method of any example herein, particularly any one of examples 33-38, further comprising retracting the one or more holding devices away from the prosthetic device after inflating the balloon to radially expand the prosthetic device.

[0533] Example 40. The method of any example herein, particularly either example 26 or example 27, wherein the balloon is mounted around a shaft of the delivery apparatus, and wherein the inflating the balloon includes radially expanding the plurality of pleats away from the shaft without causing the balloon to rotate relative to the shaft.

[0534] Example 41. The method of any example herein, particularly example 40, wherein the plurality of pleats comprises a first group of pleats that curve around the central longitudinal axis in a first direction and a second group of pleats curve around the centrallongitudinal axis in an opposite, second direction, and wherein a number of pleats in the first group are equal to a number of pleats in the second group.

[0535] Example 42. The method of any example herein, particularly example 40, wherein each pleat of the plurality of pleats has no directional bias in a circumferential direction.

[0536] Example 43. The method of any example herein, particularly example 40, wherein the plurality of pleats is arranged into a plurality of circumferentially extending rows of angled pleats, wherein a first group of first rows of the plurality of rows comprise pleats angling in a first direction around the balloon, relative to the central longitudinal axis of the balloon, and a second group of second rows of the plurality of rows comprise pleats angling in a second direction around the balloon.

[0537] Example 44. The method of any example herein, particularly example 43, wherein the first rows and second rows alternate with one another from a first end to a second end of the balloon.

[0538] Example 45. The method of any example herein, particularly example 40, wherein inflating the balloon includes expanding each pleat of the plurality of pleats directly radially outward relative to the central longitudinal axis of the balloon.

[0539] Example 46. The method of any example herein, particularly example 45, wherein the plurality of pleats comprises T-shaped pleats that branch off a central cavity of the balloon in a radial direction and are spaced apart around the central cavity.

[0540] Example 47. The method of any example herein, particularly example 45, wherein the plurality of pleats comprises a plurality of stacked pleats that zigzag and fold over themselves in a radial direction.

[0541] Example 48. The method of any example herein, particularly example 45, wherein the plurality of pleats comprises spiral pleats that are circumferentially spaced apart around the central longitudinal axis of the balloon.

[0542] Example 49. The method of any example herein, particularly example 48, wherein the spiral pleats comprise first spiral pleats that spiral in a first direction about a respective axis that is parallel to and radially spaced from the central longitudinal axis of the balloon and second spiral pleats that spiral in a second direction about a respective axis that is parallel to and radially spaced from the central longitudinal axis of the balloon, wherein the second direction is opposite the first direction.

[0543] Example 50. The method of any example herein, particularly any one of examples 26-49, wherein the balloon comprises two or more balloons, and wherein the two or more balloons have respective mating surfaces that are configured to couple with each other and define a central channel therebetween that is configured to receive a shaft of the delivery apparatus around which the balloons are mounted.

[0544] Example 51. The method of any example herein, particularly any one of examples 26-50, wherein the prosthetic device is a prosthetic valve, and the implantation site is a native heart valve.

[0545] Example 52. The method of any example herein, particularly any one of examples 26-50, wherein the implantation site includes a previously implanted prosthetic valve in a native heart valve.

[0546] Example 53. The method of any example herein, particularly any one of examples 26-52, further comprising mounting the prosthetic device around a portion of the delivery apparatus that is disposed proximal to the balloon, and wherein the arranging the prosthetic device around the balloon includes axially moving the prosthetic device onto the balloon after advancing the delivery apparatus toward an implantation site.

[0547] Example 54. The method of any example herein, particularly example 53, wherein axially moving the prosthetic device onto the balloon includes moving the prosthetic device over a radially extending protrusion disposed on the delivery apparatus proximal to a body portion of the balloon such that the prosthetic device partially radially expands.

[0548] Example 55. The method of any example herein, particularly any one of examples 26-54, wherein the method is performed on a living animal or on a simulation.

[0549] Example 56. A delivery apparatus comprising a shaft; and an inflatable balloon arranged around a distal end portion of the shaft, wherein the inflatable balloon comprises a proximal leg, a distal leg, and an inflatable body extending between the proximal leg and distal leg, wherein the inflatable balloon comprises a plurality of pleats that are folded against one another around the shaft in a first circumferential direction, and wherein the distal leg is circumferentially offset from the proximal leg such that the balloon is twisted in a second circumferential that is opposite the first circumferential direction.

[0550] Example 57. The delivery apparatus of any example herein, particularly example 56, wherein the first circumferential direction is a counterclockwise direction, and the second circumferential direction is a clockwise direction.

[0551] Example 58. The delivery apparatus of any example herein, particularly either example 56 or example 57, wherein the distal leg is circumferentially offset from the proximal leg by an angle in a range of 20-40 degrees.

[0552] Example 59. The delivery apparatus of any example herein, particularly any one of examples 56-58, further comprising a handle, wherein the shaft is a first shaft that extends distally from the handle, and further comprising a second shaft extending distally from the handle, the first shaft extending through the second shaft.

[0553] Example 60. The delivery apparatus of any example herein, particularly example 59, wherein the inflatable balloon is configured to receive inflation fluid via a lumen defined between an outer surface of the first shaft and an inner surface of the second shaft.

[0554] Example 61. The delivery apparatus of any example herein, particularly either example 59 or example 60, further comprising a third shaft extending distally from the handle, the first and second shafts extending through the third shaft, and wherein the third shaft is steerable with a distal end portion that is configured to curve relative to a central longitudinal axis of the delivery apparatus.

[0555] Example 62. An assembly comprising the delivery apparatus of any example herein, particularly any one of examples 56-61 and further comprising a prosthetic valve mounted around a distal end portion of the delivery apparatus in a radially collapsed configuration, wherein the balloon is configured to radially expand the prosthetic valve as it inflates, and wherein the prosthetic valve is configured to radially expand such that its rotational position relative to the shaft is the same prior to and after inflation of the balloon and unfurling of the plurality of pleats.

[0556] Example 63. A delivery apparatus, comprising a shaft; and an inflatable balloon arranged around a distal end portion of the shaft and configured to inflate from a deflated state to an inflated state, wherein the inflatable balloon comprises a central cavity and plurality of circumferentially spaced apart pleats branching radially outward from the central cavity in the deflated state, and wherein each pleat has a compressed shape that is configured to expand radially outward when the balloon transitions from the deflated state to the inflated state such that a net rotational force imparted by the balloon on a prosthetic valve mounted thereon during balloon inflation is zero.

[0557] Example 64. The delivery apparatus of any example herein, particularly example 63, wherein each pleat of the plurality of pleats is evenly spaced in the circumferential direction from adjacent pleats of the plurality of pleats.

[0558] Example 65. The delivery apparatus of any example herein, particularly either example 63 or example 64, wherein each pleat of the plurality of pleats has a T-shape with a stem of the T branching off the central cavity and a top of the T spaced radially from the central cavity and extending in a circumferential direction.

[0559] Example 66. The delivery apparatus of any example herein, particularly either example 63 or example 64, wherein each pleat of the plurality of pleats forms a spiral that extends radially outward from the central cavity and spirals in a circumferential direction about an axis that is parallel but radially spaced from a central longitudinal axis of the balloon.

[0560] Example 67. The delivery apparatus of any example herein, particularly example 66, wherein a first half of the plurality of pleats spiral in a first circumferential direction and a second half of the plurality of pleats spiral in a second circumferential direction that is opposite the first circumferential direction.

[0561] Example 68. The delivery apparatus of any example herein, particularly either example 63 or example 64, wherein each pleat of the plurality of pleats is folded over itself a plurality of times to form a stack of zig-zagging folds that extends radially away from the central cavity.

[0562] Example 69. An assembly comprising the delivery apparatus of any example herein, particularly any one of examples 63-68 and further comprising a prosthetic valve mounted around a distal end portion of the delivery apparatus in a radially collapsed configuration, wherein the balloon is configured to radially expand the prosthetic valve as it inflates, and wherein the prosthetic valve is configured to radially expand such that its rotational position relative to the shaft before and after balloon inflation is maintained.

[0563] Example 70. A delivery apparatus comprising a first shaft; a second shaft extending through the first shaft with a distal end portion that extends distally beyond a distal end of the first shaft; an inflatable balloon arranged around the distal end portion of the second shaft and coupled to the distal end of the first shaft, wherein the inflatable balloon is configured to inflate from a compressed and deflated state to an expanded and inflated state; and a sleevearranged around at least a portion of the inflatable balloon in both the deflated state and the inflated state.

[0564] Example 71. The delivery apparatus of any example herein, particularly example 70, wherein the sleeve is a polymeric sleeve comprising a polymer.

[0565] Example 72. The delivery apparatus of any example herein, particularly either example 70 or example 71, further comprising a lubricating coating arranged between the sleeve and the portion of the inflatable balloon.

[0566] Example 73. The delivery apparatus of any example herein, particularly any one of examples 70-72, wherein the sleeve is configured to stretch and not stick to the inflatable balloon.

[0567] Example 74. The delivery apparatus of any example herein, particularly any one of examples 70-73, wherein the sleeve is retractable.

[0568] Example 75. The delivery apparatus of any example herein, particularly example 74, further comprising a handle, wherein the first and second shafts extend distally from the handle, and wherein the sleeve is coupled to the handle by a pull wire or suture.

[0569] Example 76. The delivery apparatus of any example herein, particularly any one of examples 70-73, wherein the sleeve is a membrane extending over at least the portion of the inflatable balloon, and wherein the membrane is configured to break or dissolve as the inflatable balloon inflates and expands radially outward.

[0570] Example 77. An assembly comprising the delivery apparatus of any example herein, particularly any one of examples 70-76 and further comprising a prosthetic valve mounted around a distal end portion of the delivery apparatus in a radially collapsed configuration, wherein the polymeric sleeve is configured to receive the prosthetic valve thereon, and wherein the prosthetic valve is configured to radially expand without rotating when the balloon inflates.

[0571] Example 78. A delivery apparatus comprising a shaft; and an inflatable balloon arranged around a distal end portion of the shaft and configured to inflate from a deflated state to an inflated state; and one or more holding members configured to couple to an end of a prosthetic valve arranged around the balloon and hold the prosthetic valve rotationally in place as the balloon inflates to the inflated state, wherein each holding member of the one or more holding members is configured to move radially outward as the balloon inflates and prosthetic valve radially expands.

[0572] Example 79. The delivery apparatus of any example herein, particularly example 78, wherein the inflatable balloon comprises a plurality of pleats that are folded against one another and spiral around the shaft in a first circumferential direction.

[0573] Example 80. The delivery apparatus of any example herein, particularly either example 78 or example 79, further comprising a distal tip mounted to an end of the shaft, and wherein the one or more holding members includes a first holding member that extends from the distal tip and over a distal end portion of the balloon.

[0574] Example 81. The delivery apparatus of any example herein, particularly any one of examples 78-80, wherein the shaft is a first shaft, and further comprising a second shaft, wherein the first shaft extends through the second shaft and the distal end portion of the first shaft extends distally beyond a distal end of the second shaft, and wherein the one or more holding members includes a second holding member that extends from the distal end of a second shaft and over a proximal end portion of the balloon.

[0575] Example 82. The delivery apparatus of any example herein, particularly any one of examples 78-81, wherein the one or more holding members includes a radially expandable frame.

[0576] Example 83. The delivery apparatus of any example herein, particularly any one of examples 78-81, wherein the one or more holding members includes one or more wires or sutures.

[0577] Example 84. The delivery apparatus of any example herein, particularly either example 78 or example 79, wherein the shaft is a first shaft, and further comprising a second shaft, wherein the first shaft extends through the second shaft and the distal end portion of the first shaft extends distally beyond a distal end of the second shaft, and wherein the one or more holding members comprises a distal tip of the second shaft that comprises mating features configured to couple to an end of the prosthetic valve.

[0578] Example 85. The delivery apparatus of any example herein, particularly example 84, wherein the mating features are teeth.

[0579] Example 86. An assembly comprising the delivery apparatus of any example herein, particularly any one of examples 78-85 and further comprising a prosthetic valve mounted around a distal end portion of the delivery apparatus in a radially collapsed configuration, wherein the one or more holding members are coupled to one or more ends of the prostheticvalve, and wherein the prosthetic valve is configured to radially expand when the balloon inflates.

[0580] Example 87. A method comprising shaping an inflatable balloon of a delivery apparatus into a first shape having a central cavity and a plurality of circumferentially spaced and radially extending sections extending outward from the central cavity; and compressing each radially extending section of the plurality of circumferentially spaced and radially extending sections radially inward toward a central longitudinal axis of the balloon, thereby forming the balloon into a compressed and deflated state having a second shape.

[0581] Example 88. The method of any example herein, particularly example 87, wherein each radially extending section has a bulbous shape.

[0582] Example 89. The method of any example herein, particularly either example 87 or example 88, wherein compressing each radially extending section radially inward includes compressing each radially extending section radially inward to form a T-shaped section extending from the central cavity.

[0583] Example 90. The method of any example herein, particularly any one of examples 87-89, wherein the second shape comprises the central cavity and a plurality of T-shaped sections spaced circumferentially apart around the central longitudinal axis.

[0584] Example 91. The method of any example herein, particularly any one of examples 87-90, further comprising arranging the central cavity around a distal end portion of a shaft of the delivery apparatus.

[0585] Example 92. The method of any example herein, particularly example 91, further comprising mounting a prosthetic valve in a radially collapsed configuration on a distal end portion of the delivery apparatus, and arranging the prosthetic valve around the balloon in the compressed and deflated state.

[0586] Example 93. The method of any example herein, particularly example 92, further comprising inflating the balloon and radially expanding the prosthetic valve such that a net rotational force imparted by the balloon to the prosthetic valve during balloon inflation is zero.

[0587] Example 94. A method comprising shaping an inflatable balloon of a delivery apparatus into a first shape, wherein the first shape is a polygonal shape having four sides; folding corners of polygonal shaped balloon radially inward toward a central longitudinal axis of the balloon; and inserting the folded balloon into a forming mold and shaping theinflatable balloon into a second shape comprising a central cavity and a plurality of circumferentially spaced apart wings that extend radially outward from the central cavity, wherein each wing has an attached end attached to the central cavity and a free end spaced radially away from the central cavity, wherein the free end is wider than the attached end.

[0588] Example 95. The method of any example herein, particularly example 94, wherein each wing of the plurality of wings is spaced equidistance from adjacent wings of the plurality of wings.

[0589] Example 96. The method of any example herein, particularly either example 94 or example 95, wherein the first shape is a cuboid shape which defines a body of the balloon, and wherein the balloon in the first shape further comprises conical end portions extending outward from the body.

[0590] Example 97. The method of any example herein, particularly any one of examples 94-96, wherein the balloon in the first shape has four sides that meet at right angles to define the corners of the polygonal shaped balloon.

[0591] Example 98. The method of any example herein, particularly any one of examples 94-97, wherein the forming mold comprises an outer annular ring with a plurality of circumferentially spaced wedges that extend from the outer annular ring and radially inward toward a center of the forming mold.

[0592] Example 99. A method comprising pleating and folding a balloon to create a plurality of pleats that wrap around a central cavity of the balloon in a first circumferential direction; and twisting the balloon such that a distal leg of the balloon is circumferentially offset from a proximal leg of the balloon in a second circumferential direction that is opposite the first circumferential direction, and wherein the balloon comprises an intermediate portion disposed between the proximal leg and distal leg.

[0593] Example 100. The method of any example herein, particularly example 99, further comprising shaping the balloon into a compressed and deflated configuration prior to or during the act of twisting the balloon.

[0594] Example 101. The method of any example herein, particularly example 100, wherein shaping the balloon includes arranging at least one sleeve around at least a portion of the balloon and compressing the portion of the balloon by applying heat and force to the sleeve.

[0595] Example 102. The method of any example herein, particularly example 101, wherein the at least one sleeve is a shrink tube.

[0596] Example 103. The method of any example herein, particularly any one of examples 100-102, wherein shaping the balloon includes arranging a first sleeve around a proximal cone of the balloon and radially compressing the proximal cone, wherein the proximal cone is disposed between the proximal leg and the intermediate portion.

[0597] Example 104. The method of any example herein, particularly example 103, wherein shaping the balloon includes arranging a second sleeve around at least a portion of the pleated and folded intermediate portion of the balloon and radially compressing the portion of the pleated and folded intermediate portion.

[0598] Example 105. The method of any example herein, particularly any one of examples 99-104, wherein the circumferential offset between the distal leg and the proximal leg is in a range of 15 to 45 degrees.

[0599] Example 106. The method of any example herein, particularly any one of examples 99-105, wherein the pleating and folding comprises forming the plurality of pleats with an apparatus and wrapping the plurality of pleats around the central cavity of the balloon in the first circumferential direction.

[0600] Example 107. The method of any example herein, particularly any one of examples 99-106, further comprising mounting the balloon around a shaft of a delivery apparatus.

[0601] Example 108. A delivery apparatus comprising a handle; a shaft extending distally from the handle; and an inflatable balloon arranged around a distal end portion of the shaft and configured to inflate from a deflated and compressed state to an inflated state, wherein in the deflated and compressed state the inflatable balloon comprises a central cavity surrounding the shaft and a plurality of pleats extending outward from the central cavity, wherein the plurality of pleats are grouped into pairs of adjacently arranged pleats, each pair comprising a first pleat that forms a spiral that extends radially outward from the central cavity and spirals in a first circumferential direction about an axis that is parallel to but radially spaced from a central longitudinal axis of the balloon and a second pleat that forms a spiral that extends radially outward from the central cavity and spirals in a second circumferential direction about an axis that is parallel to but radially spaced from the central longitudinal axis of the balloon, wherein the second circumferential direction is opposite the first circumferential direction.

[0602] Example 109. The delivery apparatus of any example herein, particularly example 108, wherein the first pleat and second pleat of each pair spiral toward one another.

[0603] Example 110. The delivery apparatus of any example herein, particularly either example 108 or example 109, wherein the plurality of pleats includes at least two pairs of adjacently arranged pleats.

[0604] Example 111. The delivery apparatus of any example herein, particularly any one of examples 108-110, wherein the pairs of adjacently arranged pleats are spaced circumferentially apart around the central cavity.

[0605] Example 112. A delivery apparatus comprising a first shaft comprising a distal tip, wherein the distal tip has an end portion with mating features that are configured to engage a prosthetic device mounted on a distal end portion of the delivery apparatus and prevent rotation of the prosthetic device; a second shaft extending through the first shaft and having a distal end portion extending distally beyond the distal tip of the first shaft; and an inflatable balloon arranged around the distal end portion of the second shaft.

[0606] Example 113. The delivery apparatus of any example herein, particularly example 112, wherein the end portion of the distal tip flares radially outward relative to an outer surface of the first shaft.

[0607] Example 114. The delivery apparatus of any example herein, particularly either example 112 or example 113, wherein the mating features comprise a plurality of indentations formed in a distal face of the distal tip.

[0608] Example 115. The delivery apparatus of any example herein, particularly any one of examples 112-114, wherein the distal tip is configured to expand radially outward and compress radially inward.

[0609] Example 116. The delivery apparatus of any example herein, particularly any one of examples 112-115, further comprising a rotatable third shaft extending through the first shaft and around the second shaft, and wherein the distal end portion of the second shaft extends distally beyond a distal end of the third shaft.

[0610] Example 117. The delivery apparatus of any example herein, particularly example 116, wherein a proximal end portion of the inflatable balloon is coupled directly to the distal end of the third shaft.

[0611] Example 118. The delivery apparatus of any example herein, particularly example 116, wherein a proximal end portion of the inflatable balloon is coupled to the distal end of the third shaft through a crimp balloon that extends between the inflatable balloon and thethird shaft, and wherein the crimp balloon is configured to transfer torque form the third shaft to the inflatable balloon.

[0612] Example 119. An assembly comprising the delivery apparatus of any example herein, particularly any one of examples 112-118, and further comprising a prosthetic device arranged in a radially collapsed configuration around the inflatable balloon.

[0613] Example 120. The assembly of any example herein, particularly example 119, wherein the mating features are configured to engage to a proximal end of the prosthetic device and hold the prosthetic device stationary in a circumferential direction.

[0614] Example 121. The assembly of any example herein, particularly either example 119 or example 120, wherein the prosthetic device is a prosthetic valve, and wherein the mating features are configured to receive apices of a frame of the prosthetic valve.

[0615] Example 122. The assembly of any example herein, particularly any one of examples 119-121, wherein the mating features comprise teeth.

[0616] Example 123. A method comprising engaging mating features of a distal tip of a first shaft of a delivery apparatus to a proximal end of a prosthetic device arranged around an inflatable balloon of the delivery apparatus in a radially collapsed configuration, wherein the inflatable balloon is mounted around a second shaft of the delivery apparatus that extends through the first shaft; inflating the inflatable balloon a first amount while the distal tip holds the prosthetic device in place in a rotational direction; retracting the distal tip proximally, away from the prosthetic device; and inflating the inflatable a second amount to radially expand and deploy the prosthetic device at an implantation site.

[0617] Example 124. The method of any example herein, particularly example 123, wherein the prosthetic device is initially mounted on the delivery apparatus proximal to the inflatable balloon, and further comprising, prior to inflating the inflatable balloon the first amount, axially moving the first shaft and the second shaft relative to one another to move the prosthetic device onto the inflatable balloon.

[0618] Example 125. The method of any example herein, particularly either example 123 or example 124, further comprising, prior to inflating the inflatable balloon the first amount, rotating the second shaft to rotate the inflatable balloon and the prosthetic device into a desired rotational orientation for deployment.

[0619] Example 126. The method of any example herein, particularly any one of examples 123-125, wherein the inflatable balloon comprises a plurality of pleats folded around a centralaxis of the balloon prior to inflating the first amount, and wherein inflating the inflatable balloon the first amount includes unfurling the plurality of pleats.

[0620] Example 127. The method of any example herein, particularly any one of examples 123-126, wherein after inflating the inflatable balloon the first amount, the prosthetic device is at least partially radially expanded compared to its radially collapsed configuration.

[0621] Example 128. The method of any example herein, particularly any one of examples 123-127, wherein the prosthetic device is a prosthetic valve.

[0622] Example 129. The method of any example herein, particularly any one of examples 123-128, wherein the implantation site is a native heart valve.

[0623] Example 130. A delivery apparatus comprising a handle; a first shaft extending distally from the handle; a second shaft extending distally from the handle and through the first shaft and having a distal end portion extending distally beyond a distal end of the first shaft; an inflatable balloon arranged around the distal end portion of the second shaft; and a protrusion offset from a body portion of the inflatable balloon in a proximal direction, wherein the protrusion extends radially outward relative to a central longitudinal axis of the delivery apparatus, and wherein a portion of the delivery apparatus disposed proximal to the protrusion is configured to receive a prosthetic valve mounted thereon in a radially collapsed configuration.

[0624] Example 131. The delivery apparatus of any example herein, particularly example 130, wherein the protrusion is on the second shaft.

[0625] Example 132. The delivery apparatus of any example herein, particularly example 130, wherein the protrusion is on a proximal leg of the inflatable balloon.

[0626] Example 133. The delivery apparatus of any example herein, particularly any one of examples 130-132, wherein the first shaft and the second shaft are axially movable relative to one another.

[0627] Example 134. The delivery apparatus of any example herein, particularly example 133, wherein the first shaft comprises a distal tip that is configured to push the prosthetic valve over the protrusion and onto the body portion of the inflatable balloon when the first and second shafts are axially moved relative to one another.

[0628] Example 135. The delivery apparatus of any example herein, particularly any one of examples 130-134, further comprising a third shaft extending around the first shaft, and wherein the third shaft is rotatable relative to the first shaft.

[0629] Example 136. The delivery apparatus of any example herein, particularly example 135, further comprising a crimp balloon coupled between a distal end of the third shaft and a proximal end portion of the inflatable balloon, and wherein the protrusion is arranged between the crimp balloon and the body portion of the inflatable balloon.

[0630] Example 137. An assembly comprising the delivery apparatus of any example herein, particularly example 136, and further comprising a prosthetic valve mounted in a radially collapsed configuration around the crimp balloon.

[0631] Example 138. A method comprising advancing a distal end portion of a delivery apparatus toward an implantation site, wherein a prosthetic valve is mounted on the distal end portion, proximal to an inflatable balloon of the delivery apparatus and proximal to a protrusion that extends radially outward from a shaft of the delivery apparatus around which the inflatable balloon is arranged; axially moving the prosthetic valve over the protrusion and onto the inflatable balloon, and partially radially expanding the prosthetic valve as it moves over the protrusion; and inflating the inflatable balloon without rotating the prosthetic valve.

[0632] Example 139. The method of any example herein, particularly example 138, wherein, prior to inflation, the inflatable balloon comprises a plurality of pleats that are folded against one another around the shaft in a first circumferential direction.

[0633] Example 140. The method of any example herein, particularly either example 138 or example 139, wherein the inflating the balloon includes inflating the balloon a first amount that results in unfolding of the pleats of the balloon, and subsequently inflating the balloon a second amount that results in radially expanding the prosthetic valve without rotating the prosthetic valve.

[0634] Example 141. The method of any example herein, particularly any one of examples 138-140, wherein the protrusion is on the shaft.

[0635] Example 142. The method of any example herein, particularly any one of examplesl38-140, wherein the protrusion is on a proximal leg of the balloon.

[0636] Example 143. The method of any example herein, particularly any one of examples 138-142, wherein the shaft is a first shaft of the delivery apparatus, wherein the first shaft extends distally beyond a flared distal tip of a second shaft of the delivery apparatus, and wherein axially moving the prosthetic valve over the protrusion and onto the inflatable balloon includes axially moving the first shaft and the second shaft relative to one anothersuch that the flared distal tip of the second shaft pushes the prosthetic valve over the protrusion and onto the inflatable balloon.

[0637] Example 144. The method of any example herein, particularly any one of examples 138-143, further comprising, prior to the inflating the inflatable balloon, rotating the shaft to rotate the inflatable balloon and the prosthetic valve into a desired rotational orientation for deployment.

[0638] Example 145. An inflatable balloon assembly for a delivery apparatus, comprising two or more balloons coupled together, wherein each balloon of the two or more balloons comprises an outer surface; and a mating surface and a partial channel depressed into the mating surface, and wherein the two or more balloons engage each other at their respective mating surfaces to form a central channel of the balloon assembly configured to receive a shaft of the delivery apparatus, and wherein the outer surfaces of the balloons define an outer surface of the balloon assembly that has a circular cross-section profile in a plane perpendicular to a central longitudinal axis of the balloon assembly.

[0639] Example 146. The inflatable balloon assembly of any example herein, particularly example 145, wherein the central channel is fluidly separated from each balloon of the two or more balloons.

[0640] Example 147. The inflatable balloon assembly of any example herein, particularly either example 145 or example 146, further comprising a reinforcing member disposed within the central channel.

[0641] Example 148. The inflatable balloon assembly of any example herein, particularly example 147, wherein the reinforcing member is a coil that contacts a wall defining the partial channel of each balloon.

[0642] Example 149. The inflatable balloon assembly of any example herein, particularly example 147, wherein the reinforcing member is a metal or polymeric tube.

[0643] Example 150. The inflatable balloon assembly of any example herein, particularly example 147, wherein the reinforcing member is a stent structure.

[0644] Example 151. The inflatable balloon assembly of any example herein, particularly any one of examples 145-150, wherein each balloon of the two or more balloons is pleated and folded radially inward toward the central longitudinal axis of the balloon.

[0645] Example 152. The inflatable balloon assembly of any example herein, particularly example 151, wherein each balloon comprises three pleats.

[0646] Example 153. The inflatable balloon assembly of any example herein, particularly example 151, wherein each balloon comprises four pleats.

[0647] Example 154. The inflatable balloon assembly of any example herein, particularly example 151, wherein each balloon comprises six pleats.

[0648] Example 155. The inflatable balloon assembly of any example herein, particularly any one of examples 151-154, wherein the pleats comprise box pleats.

[0649] Example 156. The inflatable balloon assembly of any example herein, particularly any one of examples 145-155, wherein the inflatable balloon assembly comprises two balloons, each shaped as a half cylinder.

[0650] Example 157. The inflatable balloon assembly of any example herein, particularly any one of examples 145-155, wherein the inflatable balloon assembly comprises three balloons, each shaped as a third of a whole cylinder.

[0651] Example 158. The inflatable balloon assembly of any example herein, particularly any one of examples 145-157, wherein the partial channel of each balloon is a partial cylindrical channel.

[0652] Example 159. The inflatable balloon assembly of any example herein, particularly any one of examples 145-158, wherein the two or more balloons are fluidly separated from each other.

[0653] Example 160. The inflatable balloon assembly of any example herein, particularly any one of examples 145-159, wherein the balloon assembly is cylindrical.

[0654] Example 161. A delivery apparatus comprising the inflatable balloon assembly of any example herein, particularly any one of examples 145-160; and a shaft extending through the central channel of the inflatable balloon assembly.

[0655] Example 162. A folding tool for folding an inflatable balloon, comprising a first body having a first end and an opposing, second end, the first body comprising: a central bore extending axially through the first body from the first end to the second end of the first body; and a plurality of channels spaced circumferentially apart around the central bore, wherein each channel extends radially outward from the central bore and extends axially from the first end to the second end of the first body, wherein a shape of each channel changes along its length, between the first end and the second end, wherein at the first end of the first body, the central bore is configured to receive a central portion of an inflatable balloon and each channel is configured to receive a respective pleat of the inflatable balloon.

[0656] Example 163. The folding tool of any example herein, particularly example 162, wherein a diameter of the central bore is larger at the second end than the first end.

[0657] Example 164. The folding tool of any example herein, particularly either example 162 or example 163, wherein at least one channel of the plurality of channels has an L shape at the first end, and wherein the at least one channel is straight at the second end.

[0658] Example 165. The folding tool of any example herein, particularly any one of examples 162-164, further comprising a second body comprising a central channel that tapers radially inward from a larger, first diameter at its first end in a first end portion of the second body to a smaller, second diameter at its second end in a second end portion of the second body, and wherein the first end portion of the second body is configured to couple to the second end of first body.

[0659] Example 166. The folding tool of any example herein, particularly example 165, wherein the central channel has a conical shape that is configured to radially compress the pleats of the inflatable balloon against the central portion of the inflatable balloon.

[0660] Example 167. The folding tool of any example herein, particularly either example 165 or example 166, wherein the first body comprises a first mating interface at its second end and the second body comprises a second mating interface at its first end portion that is configured to couple to the first mating interface such that the first end of the central channel is disposed adjacent to second ends of the plurality of channels and central bore at the second end of the first body.

[0661] Example 168. The folding tool of any example herein, particularly example 167, wherein the first mating interface comprises one or more axially extending slots.

[0662] Example 169. The folding tool of any example herein, particularly example 168, wherein the second mating interface comprises one or more axially extending protrusions, and wherein each slot is configured to receive a respective protrusion.

[0663] Example 170. The folding tool of any example herein, particularly any one of examples 167-169, wherein the first mating interface comprises an annular channel that extends axially from the second end of the first body toward the first end of the first body, and wherein the annular channel is disposed radially outward and away from the central bore.

[0664] Example 171. The folding tool of any example herein, particularly example 170, wherein the second mating interface comprises an annular extension that has a radiallyinward facing surface defining a lumen that is proximal to and continuous with the central channel, and wherein the annular channel is configured to receive the annular extension.

[0665] Example 172. The folding tool of any example herein, particularly any one of claims 162-171, wherein the first body is a cylinder.

[0666] Example 173. The method of any example herein, particularly example 87, wherein each radially extending section has an L shape.

[0667] Example 174. The method of any example herein, particularly example 173, wherein the plurality of circumferentially spaced and radially extending sections is grouped into pairs of two L-shaped pleats, and wherein the two L-shaped pleats of each pair face one another and branch off from the same location of the central cavity.

[0668] Example 175. The method of any example herein, particularly example 174, wherein the second shape comprises the central cavity, a first two oppositely arranged pairs of pleats that are folded over themselves and face one another, and a second two oppositely arranged pairs of pleats that each fold over a respective pleat of the first two oppositely arranged pairs of pleats.

[0669] Example. 176. The delivery apparatus of any example herein, particularly example 1, wherein the pleats are arranged in pairs of pleats, wherein at least one pair of pleats comprises a first pleat folded in a first circumferential direction and a second pleat folded away from the first pleat in a second circumferential direction, the first pleat and the second pleat connected by an internal layer.

[0670] Example 177. The delivery apparatus of any example herein, particularly example 1, wherein the pleats are arranged in pairs of pleats, wherein at least one pair of pleats comprises a first pleat folded in a first circumferential direction and a second pleat folded toward the first pleat in a second circumferential direction.

[0671] Example 178. The delivery apparatus of any example herein, particularly example 177, wherein another pair of pleats comprises a first pleat and a second pleat folded away from each other

[0672] Example 179. A method comprising sterilizing the prosthetic heart valve, apparatus, and / or assembly of any example.

[0673] Example 180. A prosthetic heart valve of any one of examples 1-178, wherein the prosthetic heart valve is sterilized.

[0674] The features described herein with regard to any example can be combined with other features described in any one or more of the other examples, unless otherwise stated. For example, any one or more of the features of one balloon can be combined with any one or more features of another balloon. As another example, any one or more features of one delivery apparatus can be combined with any one or more features of another delivery apparatus.

[0675] In view of the many possible ways in which the principles of the disclosure may be applied, it should be recognized that the illustrated configurations depict examples of the disclosed technology and should not be taken as limiting the scope of the disclosure nor the claims. Rather, the scope of the claimed subject matter is defined by the following claims and their equivalents.

Claims

WE CLAIM:

1. A delivery apparatus comprising:a handle;a shaft extending distally from the handle; andan inflatable balloon arranged around a distal end portion of the shaft and configured to inflate from a deflated state to an inflated state, wherein in the deflated state the inflatable balloon comprises a central cavity surrounding the shaft and a plurality of pleats, wherein each pleat of the plurality of pleats is folded such that when the balloon inflates, the pleats expand away from the shaft in a radially outward direction and unfold without rotating an implant mounted on the balloon relative to the shaft.

2. The delivery apparatus of claim 1, wherein each pleat has a T-shape in the deflated state of the inflatable balloon, wherein a stem of the T branches off the central cavity and a top of the T is spaced radially from the central cavity and extends in a circumferential direction.

3. The delivery apparatus of claim 1, wherein the pleats are arranged in pairs of pleats, wherein at least one pair of pleats comprises a first pleat folded in a first circumferential direction and a second pleat folded away from the first pleat in a second circumferential direction, the first pleat and the second pleat connected by an internal layer.

4. The delivery apparatus of claim 1, wherein the pleats are arranged in pairs of pleats, wherein at least one pair of pleats comprises a first pleat folded in a first circumferential direction and a second pleat folded toward the first pleat in a second circumferential direction.

5. The delivery apparatus of claim 4, wherein another pair of pleats comprises a first pleat and a second pleat folded away from each other.

6. The delivery apparatus of claim 1, wherein the plurality of pleats is spaced circumferentially apart from one another around the central cavity, and wherein each pleat is folded over itself a plurality of times to form a stack of zig-zagging folds that extends radially away from the central cavity.

7. The delivery apparatus of claim 1, wherein the inflatable balloon comprises at least two balloons coupled together at respective mating surfaces and defining a central channel therebetween, wherein the shaft extends through the central channel, and wherein the at least two balloons are fluidly separate from one another.

8. The delivery apparatus of any one of claims 1-7, wherein the shaft is a first shaft, and further comprising a rotatable second shaft extending distally from the handle, wherein the first shaft extends through the second shaft, and wherein the distal end portion of the first shaft extends distally beyond the first shaft.

9. The delivery apparatus of claim 8, wherein a proximal end portion of the inflatable balloon is coupled to the second shaft.

10. A method comprising:arranging a prosthetic device, in a radially collapsed configuration, around a balloon of a delivery apparatus, wherein the balloon comprises a plurality of pleats that are folded around a central longitudinal axis of the balloon, wherein the balloon is in a compressed and deflated configuration; andinflating the balloon to radially expand the prosthetic device such that a rotational position of the prosthetic device after the inflating is the same as a rotational position of the prosthetic device before the inflating.

11. The method of claim 10, further comprising, prior to inflating the balloon, delivering the prosthetic device to an implantation site and rotating the prosthetic device into a specified rotational position relative to the implantation site.

12. The method of either claim 10 or claim 11, wherein the balloon is mounted around a shaft of the delivery apparatus, and wherein the inflating the balloon includes radially expanding the plurality of pleats away from the shaft without causing the balloon to rotate relative to the shaft.

13. The method of claim 12, wherein the plurality of pleats comprises a first group of pleats that curve around the central longitudinal axis in a first direction and a second group of pleats curve around the central longitudinal axis in an opposite, second direction, and wherein a number of pleats in the first group are equal to a number of pleats in the second group.

14. The method of claim 12, wherein each pleat of the plurality of pleats has no directional bias in a circumferential direction.

15. The method of any one of claims 10-14, further comprising mounting the prosthetic device around a portion of the delivery apparatus that is disposed proximal to the balloon, and wherein the arranging the prosthetic device around the balloon includes axiallymoving the prosthetic device onto the balloon after advancing the delivery apparatus toward an implantation site.

16. The method of any one of claims 10-15, wherein the method is performed on a living animal or on a simulation.

17. A method comprising:shaping an inflatable balloon of a delivery apparatus into a first shape having a central cavity and a plurality of circumferentially spaced and radially extending sections extending outward from the central cavity; andcompressing each radially extending section of the plurality of circumferentially spaced and radially extending sections radially inward toward a central longitudinal axis of the balloon, thereby forming the balloon into a compressed and deflated state having a second shape.

18. The method of claim 17, wherein each radially extending section has an L shape.

19. The method of claim 18, wherein the plurality of circumferentially spaced and radially extending sections is grouped into pairs of two L-shaped pleats, and wherein the two L-shaped pleats of each pair face one another and branch off from the same location of the central cavity.

20. The method of claim 19, wherein the second shape comprises the central cavity, a first two oppositely arranged pairs of pleats that are folded over themselves and face one another, and a second two oppositely arranged pairs of pleats that each fold over a respective pleat of the first two oppositely arranged pairs of pleats.

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