Method of folding and forming a delivery system balloon to reduce deployed THV height asymmetry

Abstract

The present embodiments relate generally to devices, systems, and methods for expanding an implant utilizing an expansion device. One embodiment includes an expansion device for an implant. The expansion device includes an expandable body having a proximal end and a distal end, and a central body having a length located between the proximal end and the distal end. The central body is configured to press against an inner surface of the implant to expand the implant. The expandable body includes a radius of curvature of at least one outer expandable body fold that is equal to or greater than half the thickness of the expandable body.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of U.S. Provisional Patent Application No. 63 / 142,157, filed January 27, 2021, the entire contents of which are incorporated herein by reference. [Background technology]

[0002] Various diseases may affect an individual's body. Such diseases may relate to the individual's heart and may include diseases of the individual's heart valves, including the aortic, mitral, tricuspid, and pulmonary valves. Prosthetic implants, such as prosthetic heart valves, may be provided to replace portions of the patient's heart. Prosthetic aortic, mitral, tricuspid, and even pulmonary valves may be provided. The implants may be deployed in a percutaneous, minimally invasive manner to desired portions of the patient's body. Such deployment may occur transcatheter, where a catheter may be deployed through the individual's vascular system. During deployment of such implants, the implants must expand to provide an expanded configuration for such implants.

[0003] Balloon-expandable transcatheter heart valves (THVs) may sometimes be deployed with asymmetric shapes. This is undesirable because the THV may not function as well when deployed with asymmetric shapes. For example, paravalvular leakage (PVL), reduced valve durability, or both PVL and reduced valve durability may occur. Furthermore, the tissues of the THV may not be perfectly compatible. Therefore, it may be advantageous to reduce the asymmetric shape of the THV. Summary of the Invention [Means for solving the problem]

[0004] The present devices, systems, and methods may relate to devices, systems, and methods for expanding an implant, such as a THV, to reduce the likelihood that the THV will be deployed in an asymmetric shape. For example, the devices, systems, and methods described herein may include an inflatable body, such as a balloon, which may include specific balloon pleats, balloon folds, or both balloon pleats and balloon folds, and a balloon configuration such that the balloon may reduce asymmetry in THV height after deployment of the THV. Such devices, systems, and methods may include an inflatable body configured to expand to expand the implant to improve the likelihood that the expansion of the inflatable body and the deployment of the implant may be symmetric.

[0005] Embodiments herein may include an expansion device for an implant. The expansion device may include an expandable body having a proximal end and a distal end, and a central body located between the proximal end and the distal end and having a length. The central body may be configured to press against an inner surface of the implant to expand the implant. The expandable body may include a radius of curvature of at least one outer expandable body fold that is equal to or greater than half the thickness of the expandable body.

[0006] Embodiments herein may include an expansion device for an implant. The expansion device may include an expandable body having a proximal end and a distal end, and a central body located between the proximal end and the distal end and having a length. The central body may be configured to push against an inner surface of the implant to expand the implant. The expandable body may include a lubricious outer surface.

[0007] Embodiments herein may include an implant delivery system. The implant delivery system may include a delivery device. The implant delivery system may include an expandable body coupled to the delivery device and having a proximal end and a distal end, and a central body located between the proximal end and the distal end and having a length. The central body may be configured to press against an inner surface of the implant to expand the implant. The expandable body may include a radius of curvature of at least one outer expandable body fold that is equal to or greater than half the thickness of the expandable body.

[0008] Embodiments herein may include an implant delivery system. The implant delivery system may include a delivery device. The implant delivery system may include an expandable body coupled to the delivery device and having a proximal end and a distal end, and a central body located between the proximal end and the distal end and having a length. The central body may be configured to push against an inner surface of the implant to expand the implant. The expandable body may include a lubricious outer surface.

[0009] Embodiments herein may include a method including inserting an expansion device for an implant into a body. The method may include expanding the implant utilizing the expansion device. The expansion device may include an expandable body having a proximal end and a distal end, and a central body having a length located between the proximal end and the distal end. The central body may be configured to press against an inner surface of the implant to expand the implant. The expandable body may include a radius of curvature of at least one outer expandable body fold that is equal to or greater than half the thickness of the expandable body.

[0010] Embodiments herein may include a method. The method may include providing an expandable body having a proximal end and a distal end, and a central body having a length located between the proximal end and the distal end, the central body configured to press against an inner surface of the implant to expand the implant. The method may include compressing the expandable body while rotating the expandable body along an axis from the proximal end to the distal end.

[0011] Embodiments herein may include a method. The method may include inserting an expansion device for an implant into a body. The method may include utilizing the expansion device to expand the implant. The expansion device may include an expandable body having a proximal end and a distal end, and a central body having a length located between the proximal end and the distal end. The central body may be configured to press against an inner surface of the implant to expand the implant. The expandable body may be formed with a pleat inner diameter greater than a pleat height.

[0012] Embodiments herein may include a method. The method may include inserting an expansion device for an implant into a body. The method may include utilizing the expansion device to expand the implant. The expansion device may include an expandable body having a proximal end and a distal end, and a central body located between the proximal end and the distal end and having a length. The central body may be configured to press against an inner surface of the implant and expand the implant, the expandable body being formed using a mandrel positioned within the expandable body, and a ratio of a compressed outer diameter of the expandable body to an outer diameter of the mandrel is 2.5 or greater. [Brief description of the drawings]

[0013] These and other features, aspects, and advantages are described below by way of example only and not by way of limitation of the present disclosure with reference to the drawings in which like reference characters indicate corresponding features consistently throughout like embodiments.

[0014] [Figure 1] FIG. 1 is a perspective view of a deployed prosthetic valve. [Diagram 2] FIG. 2 is a top view of the artificial valve shown in FIG. [Figure 3A-3C] 3A, 3B and 3C are cross-sectional views of an inflatable body. [Figure 4A] FIG. 4A shows a perspective view of a deployed prosthetic valve. [Figure 4B] FIG. 4B shows a top view of the prosthetic valve shown in FIG. 4A. [Diagram 5] FIG. 5 shows a cross-sectional view of an inflatable body that can result in high asymmetry in deployed THV height. [Figure 6] FIG. 6 illustrates exemplary outer inflatable body fold radii of curvature. [Figure 7A] FIG. 7A shows a cross-sectional view of the relationship between pleated inner diameter and pleat height. [Figure 7B] FIG. 7B shows a cross-sectional view of the relationship between the mandrel outer diameter and the compression outer diameter. [Figure 8A] FIG. 8A shows a cross-sectional view of a pleated expandable body. [Figure 8B] FIG. 8B shows a cross-sectional view of a pleated expandable body relative to a compression tool. [Figure 8C] FIG. 8C shows a cross-sectional view of the compressed expandable body. [Figure 9A] FIG. 9A shows a cross-sectional view of a rotation of the expandable body. [Figure 9B] FIG. 9B shows a cross-sectional view of the compressed expandable body. [Figure 10] FIG. 10 shows a side view of a delivery device according to an embodiment of the present disclosure. [Figure 11] FIG. 11 illustrates a detailed view of a portion of the delivery device shown in FIG. 10 in accordance with an embodiment of the present disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0015] The following description and examples will describe in detail some exemplary embodiments of the present disclosure. Those skilled in the art will recognize that there are many variations and modifications of the present disclosure that fall within its scope. Therefore, the description of a specific exemplary embodiment should not be considered as limiting the scope of the present disclosure.

[0016] The systems and methods described herein generally relate to devices, systems, and methods for expanding an implant, such as a transcatheter heart valve (THV), such that the likelihood of the THV being deployed in an asymmetric shape is reduced. For example, the systems and methods described herein may relate to an inflatable body, such as a balloon, that may include certain balloon pleats, balloon folds, or both balloon pleats and balloon folds to form a shape that may reduce or eliminate asymmetry in the THV height after deployment of the THV. Such devices, systems, and methods may include an inflatable body configured to expand to expand an implant, where the expansion may be symmetric.

[0017] Various methods may be employed to reduce asymmetric shapes when deployed. In one embodiment, the radius of curvature of the folds of the outer expandable body may be equal to or greater than half the thickness of the expandable body. In an embodiment, the expandable body may include a lubricious exterior surface. For example, a lubricious coating may be provided on the exterior surface of the expandable body. The lubricious exterior surface may be a surface that is thermally bonded to the expandable body. In another embodiment, the lubricious exterior surface may include a textured surface. The textured surface may reduce surface friction on the expandable body exterior surface, such as reducing the contact surface area between the exterior surface of the expandable body and itself or the THV. In an embodiment, the expandable body may be compressed while rotating along an axis from the proximal end to the distal end of the expandable body. Rotation of the expandable body during the compressing operation of the expandable body may be used to eliminate or reduce the formation of pleat hooks. In some aspects, one or more of the various methods or other features described above may be combined to reduce the formation of asymmetric shapes when the expandable body is deployed. In one aspect, the lubricious exterior surface of the expandable body may be a bead blasted surface or other reduced friction surface or coating. Bead blasting may include blasting small particles, such as quartz sand or small spherical particles of glass or other small particles, onto the exterior surface of the expandable body. Such blasting may be blasting small particles at high pressure.

[0018] FIG. 1 illustrates a perspective view of an implant 10 in the form of a prosthetic valve. In embodiments, the prosthetic valve may include a transcatheter heart valve (THV), as depicted in FIG. 1, or in embodiments may include another form of prosthetic valve, as desired. In embodiments, other forms of implants may be utilized, as desired. As depicted, the implant 10 may have an asymmetric shape. As discussed above, an asymmetric shape may be undesirable. The configuration depicted in FIG. 1 may represent an undesirable deployment of the implant 10.

[0019] The implant 10 may include a body 12 that may have a proximal end 14, a distal end 16, and a height between the proximal end 14 and the distal end 16. The proximal end 14 may comprise the outflow end of the implant 10, and the distal end 16 may comprise the inflow end of the implant 10.

[0020] The body 12 may comprise a valve body that may include a frame 20 that may include a plurality of struts 22 that may be joined together at joints 24 and may have spaces 26 between the struts 22. The spaces 26 may include openings in the frame 20 that may allow fluid to flow therethrough or other components to pass therethrough. The configuration of the frame may vary in other embodiments.

[0021] The frame 20 may be configured such that the body 12 is foldable and expandable, and the frame 20 may be crimped to move to a folded (i.e., unfolded or unexpanded) state and expanded to move to an expanded (or unfolded) state. The struts 22 may be configured to move closer together to allow the frame 20 to move to the folded state. The width of the opening between the struts 22 may decrease as the frame 20 moves to the folded (i.e., unfolded or unexpanded) state, and the length of the opening may increase. The struts 22 of the frame 20 may be configured to move circumferentially away from each other to the expanded state. The width of the opening between the struts 22 may increase as the frame 20 moves to the expanded (or unfolded) state, and the length of the opening may decrease.

[0022] The body 12 may further include one or more covers 27 that may cover a portion of the frame 20. The cover 27 may comprise a skirt that may extend circumferentially around the frame 20 and may be positioned to form all or a portion of the exterior surface 30 of the valve body 12. The cover 27 may enhance fixation of the implant 10 when deployed at a desired location within a patient's body.

[0023] The body 12 may enclose a flow passage 28 (shown in FIG. 2) that may allow for the flow of a fluid (e.g., blood or another fluid) through the body 12. The body 12 may include an outer surface 30 that may face outwardly from the body 12 and may include an inner surface 32 (shown in FIG. 2) that faces the flow passage 28. The outer surface 30 may include an anchor surface that may be utilized to secure the implant 10 within a desired portion of a patient's body (e.g., a heart valve annulus, if desired). The outer surface 30 may apply a force radially outward to secure the implant 10 within the annulus.

[0024] A number of leaflets 34 may be positioned within the flow passage 28 and may extend inwardly from the inner surface 32 of the valve body 12. Each leaflet 34 may include a proximal end 39 that may form an edge of the leaflet 34 of the valve in the outflow direction. The proximal end 39 may be opposite the distal end of each leaflet. The implant 10 may include three leaflets 34, as shown in Figures 1 and 2, or may include a greater or lesser number of leaflets 34, as desired.

[0025] The leaflets 34 may move between an open state (fluid flows through the flow passage 28) and a closed state (fluid flow through the flow passage 28 is prevented), which may mimic the movement of the leaflets of a natural heart valve. The leaflets 34 may move such that the proximal ends 39 move radially inward toward one another to contact one another to close the valve, and then move radially outward away from one another to open the valve. The leaflets 34 may open in a proximal direction. For example, FIG. 2 shows the leaflets 34 in an open state, with the leaflets 34 positioned radially outward away from one another. The leaflets 34 may open to allow flow in a proximal or outflow direction of the prosthetic valve 10, and may close to prevent flow in a distal or inflow direction of the prosthetic valve 10.

[0026] 2, for example, illustrates a schematic top view of the implant 10, which may have an asymmetric shape. FIG. 2 illustrates the leaflets 34 in an open configuration, allowing fluid flow through the flow passage 28.

[0027] The implant 10 may be configured to be deployed in a portion of a patient's body. The implant 10 may be configured to be delivered to an implantation site utilizing a delivery device. FIG. 10 illustrates an embodiment of a delivery device 1044 that may be utilized, for example, to deliver an implant (e.g., a prosthetic valve such as a THV as shown in FIGS. 1 and 2) to a desired implantation site. The delivery device 1044 may include an elongate shaft 1046 having a distal portion 1048 and a proximal portion 1050. The proximal portion 1050 may be coupled to a housing in the form of a handle 1052. The distal portion 1048 may include an implant holding area 1054 and a distal tip that may include a nose cone 1056.

[0028] The distal portion 1048 may further include an expandable body 1058, which may take the form of a balloon.

[0029] The handle 1052 may be configured for a user to grasp and manipulate the delivery device 1044 and to steer the delivery device 1044 through the vascular system of a patient's body. For example, the handle 1052 may be moved distally to advance the elongate shaft 1046 distally within the patient's body, and may be moved proximally to retract the elongate shaft 1046 proximally within the patient's body. As such, the implant holding area 1054, and therefore the implant, may be moved and positioned by manipulation of the handle 1052.

[0030] A control mechanism 1060 may further be coupled to the handle 1052. The control mechanism 1060 may be configured to be manipulated to bend the elongated shaft 1046, as desired. For example, one or more pull tethers may extend along the elongated shaft 1046, and manipulation of the control mechanism 1060 may push or pull the one or more pull tethers to bend the elongated shaft 1046. Thus, bending of the elongated shaft 1046 may be controlled by the control mechanism 1060. As shown in FIG. 10, the control mechanism 1060 may comprise a rotatable body in the form of a control knob that can be rotated to push or pull the pull tethers and bend the elongated shaft 1046. Other forms of control mechanisms may be utilized as desired.

[0031] A fluid port 1062 may further be coupled to the handle 1052 and may be utilized to transfer fluid to and from the expandable body 1058, as desired. The configuration of the handle 1052 may be varied in other embodiments, as desired.

[0032] FIG. 11 illustrates a close-up view of a distal portion 1048 of the elongated shaft 1046. The elongated shaft 1046 may include one or more shafts, which may include one or more sheaths extending over one another. For example, the elongated shaft 1046 may include an outer sheath 1064, which may be configured to extend over and be slidable relative to an intermediate sheath 1066, which may include a central shaft or shaft interior (within the lumen of the outer sheath 1064) of the outer sheath 1064. The intermediate sheath 1066 may extend over an inner shaft 1068, which may extend to a nose cone 1056 of the elongated shaft 1046. The inner shaft 1068 may be surrounded by an expandable body 1058. The inner shaft 1068 of an embodiment may include a fluid conduit that allows fluid to pass into and out of the expandable body 1058 to inflate and deflate the expandable body 1058, respectively. The other shaft may include one or more fluid conduits for expanding and contracting the expandable body 1058, as desired.

[0033] The inner shaft 1068 may further include a distal shoulder 1070 that may be positioned distal to the implant holding area 1054. The distal shoulder 1070 includes a portion of the delivery device 1044 positioned distal to the implant holding area 1054 as well as other portions such as the distal tip including the nosecone 1056 and distal end 1072 of the expandable body 1058. The distal shoulder 1070 may project radially outward from the inner shaft 1068 and may have a conical shape, if desired. The taper of the conical shape may be configured such that the distal shoulder 1070 increases in size in a direction toward the implant holding area 1054. The distal shoulder 1070 may be configured to protect an implant positioned within the implant holding area 1054 as the elongated shaft 1046 is advanced through the patient's body. For example, the outer diameter of the distal shoulder 1070 may be equal to or greater than the diameter of the implant when it is in a crimped state, thus preventing a leading edge (such as the distal end of the implant) from contacting a portion of the patient's body or from getting caught or trapped in a sheath through which the elongate shaft 1046 may be advanced. In embodiments, the configuration of the delivery device may be varied from the configuration shown in FIGS.

[0034] The implant retaining area 1054 may be configured such that the implant 10 is crimped onto the expandable body 1058 and positioned on a central body 1081 of the expandable body 1058, which may be between a distal shoulder 1076 and a proximal shoulder 1078 of the expandable body 1058. The implant 10 may be positioned proximal of the distal shoulder 1076 and crimped into such position. In certain embodiments, the outer sheath 1064 may be advanced distally to cover the implant positioned within the implant retaining area 1054 when the implant is crimped onto the expandable body 1058.

[0035] In embodiments, the inner shaft 1068 may include a shoulder (not shown) proximal to the implant retaining area 1054. In such embodiments, the proximal shoulder 1078 of the expandable body 1058 may extend over the proximal shoulder of the inner shaft 1068. In particular, in embodiments, the proximal shoulder 1078 of the expandable body 1058 may be shaped as a shoulder without extending over the shoulder of the inner shaft 1068.

[0036] Thus, the inner shaft 1068 may lack an internal proximal shoulder in embodiments.

[0037] The delivery apparatus 1044 may include an expansion device for the implant 10, which may be in the form of an expandable body 1058. The expandable body 1058 may have a distal end 1072 and a proximal end 1074 and may extend over the inner shaft 1068 and the distal shoulder 1070. A central body 1081 may be positioned between the proximal end 1074 and the distal end 1072 and may have a length 1080. The central body 1081 may be configured to push against the inner surface 32 of the implant 10 (shown in FIG. 2 ) to expand the implant 10.

[0038] A distal end 1072 of the expandable body 1058 may be coupled to the nosecone 1056 and a proximal end 1074 may be coupled to the intermediate sheath 1066. The expandable body 1058 may extend along the length of, or may surround, the inner shaft 1068. The expandable body 1058 is shown in a contracted state in FIG. 11 and may have a distal shoulder 1076 and a proximal shoulder 1078. The implant retaining area 1054 may have a length between the distal shoulder 1076 and the proximal shoulder 1078 that may correspond to the length 1080 of the central body 1081.

[0039] The expandable body 1058 can include an exterior surface 1083. The exterior surface 1083 can be configured to press against the interior surface 32 of the implant 10 (shown in FIG. 2) to expand the implant 10.

[0040] The expandable body 1058 may include a number of folds 1084 or pleats. The folds 1084 or pleats may be present when the expandable body 1058 is in an unexpanded state or may be present during formation of the expandable body 1058. The folds 1084 or pleats may allow the expandable body 1058 to be in an unexpanded, undeployed, unexpanded, or compressed configuration and then to expand radially outwardly to an expanded, deployed, expanded, or uncompressed configuration, whereupon the diameter of the expandable body 1058 increases and the implant 10 expands radially outward.

[0041] In operation, the expandable body 1058 may be formed with folds 1084 or pleats and may be coupled to the delivery device 1044. The expandable body 1058 may be provided in an unexpanded, undeployed, unexpanded, or compressed configuration. The implant 10 may then be positioned over the expandable body 1058 and may be crimped or otherwise compressed to the expandable body 1058. The delivery device 1044 may then be inserted into the patient. With the implant 10 in a desired location within the patient, such as proximal to an implantation site, fluid may be flowed, for example, through the fluid port 1062 to expand the expandable body 1058. The expandable body 1058 may expand radially outward to an expanded, deployed, expanded, or uncompressed configuration, whereupon the diameter of the expandable body 1058 increases and the implant 10 expands radially outward and is deployed.

[0042] As discussed herein, it may be undesirable to provide the implant 10 with an asymmetric shape upon deployment of the implant 10. With reference to FIG. 1, for example, the height of the implant 10 may be asymmetric, with the height of the rightmost portion of the implant 10 shown in FIG. 1 being less than the height of the leftmost portion of the implant 10 shown in FIG. 1. This generally undesirable feature may be produced for a variety of reasons. For example, the expansion of the expandable body used to expand the implant 10 may be asymmetric. Asymmetric expansion may result from certain portions of the expandable body expanding or widening at different times than other portions, resulting in asymmetric expansion of the expandable body. In this manner, an asymmetrically expanded expandable body may expand different portions of the implant 10 at different rates, for example, the leftmost portion of the implant 10 shown in FIG. 1 may expand faster than the rightmost portion of the implant 10 shown in FIG. 1, which may cause the height asymmetry shown in FIG. 1. Other features may result in undesirable asymmetric deployment of the implant 10.

[0043] Features of the expandable body may increase the likelihood of undesirable asymmetric deployment of the implant 10. Figure 5, for example, illustrates features of the expandable body that may be undesirable. The view of Figure 5 is a cross-sectional view of the expandable body 500 taken along a midline extending perpendicular to the axis of the expandable body 500. The folds 502 or pleats of the expandable body 500 are shown overlapping one another. A sheath 504 is shown extending over the folds 502 or pleats, although in practice the sheath 504 may be omitted. An inner shaft 503 or guidewire shaft is shown surrounded by the expandable body 500.

[0044] The configuration of the expandable body 500 may result in high asymmetry in deployed implant height. Features of the expandable body 500 that may contribute to such asymmetry in the implant 10 may include close, compact expandable body folds or pleats. Such features may include disorganized expandable body folds or pleats. Such features may include expandable body folds or pleats with closely spaced hooks. Close, compact expandable body folds or pleats, disorganized expandable body folds or pleats, and / or expandable body folds or pleats with closely spaced hooks may result in high asymmetry in deployed implant height. For example, close, compact expandable body folds or pleats, disorganized expandable body folds or pleats, and / or expandable body folds or pleats with closely spaced hooks, one or more of the folds or pleats may get stuck during deployment. Thus, folds or pleats of a closely packed compact inflatable body, folds or pleats of a disorganized inflatable body, or folds or pleats of an inflatable body with closely packed hooks may deploy in an asymmetric manner due to one or more of the folds or pleats getting caught (e.g., attached to each other) and therefore fail to deploy as quickly as other pleats of a particular inflatable body (e.g., folds or pleats of a closely packed compact inflatable body, folds or pleats of a disorganized inflatable body, and / or folds or pleats of an inflatable body with closely packed hooks).

[0045] 5, for example, shows hooks 506 in the folds 502 or pleats of the expandable body 500. Such hooks 506 may catch and open at a different time than the remainder of the folds 502 at the end of deployment. Thus, the folds 502 may unfold in an asymmetric manner due to the presence of the hooks 506. With respect to the implant 10, such asymmetries may thus develop in the frame 20 and continue until fully deployed, which may result in undesirable asymmetric deployment, as shown in FIG.

[0046] Additionally, tightly packed, compact expandable body folds or pleats, or unordered expandable body folds or pleats, may result from the desire for a large inner diameter of the inner lumen 508 for fluid flow and a small outer diameter of the expandable body 500 to minimize the diameter of the crimped implant 10. However, such tightly packed, compact expandable body pleats or unordered expandable body folds or pleats may result in asymmetric spreading of the folds or pleats during expansion of the expandable body, and thus asymmetric expansion of the expandable body and implant.

[0047] The systems, devices, and methods described herein may, in some cases, be used to reduce or eliminate such undesirable asymmetric resultant shapes of the implant 10. The expandable body features disclosed herein may be designed to reduce or eliminate undesirable features, as disclosed with respect to FIG. 5 and shown in the asymmetric deployment of FIGS. 1 and 2.

[0048] 3A shows a cross-sectional view of an expansion device in the form of an expandable body 300 that may be utilized, for example, according to embodiments herein. The cross-sectional view is taken along a midline extending perpendicular to the axis of the expandable body 300. For example, the midline may correspond to line AA shown in FIG. 11. The folds 302 or pleats of the expandable body 300 are shown overlapping one another. Although a sheath 304 is shown extending over the folds 302 or pleats, in practice the sheath 304 may be omitted. An inner shaft 303 or guidewire shaft is shown surrounded by the expandable body 300 and positioned within the inner lumen 301 of the expandable body 300. The expandable body 300 may include an outer surface 306 that may be configured to press against the inner surface 32 of the implant 10 (shown in FIG. 2) to expand the implant 10 with the sheath 304 removed.

[0049] Features of the expandable body 300 may correspond to features of the expandable body 1058 shown in FIG. 11. For example, the expandable body 300 may be configured similarly to the expandable body 1058 shown in FIG. 11. The folds 302 or pleats may correspond to the folds 1084 or pleats shown in FIG. 11. The inner shaft 303 may correspond to the inner shaft 1068 shown in FIG. 11. The expandable body 300 may be coupled to a delivery device and expand or contract in a manner similar to the expandable body 1058 shown in FIG. 11. Similar to the expandable body 1058 shown in FIG. 11, the expandable body 300 may have a proximal end and a distal end and a central body having a length positioned between the proximal end and the distal end. The central body may be configured to push against an inner surface of the implant to expand the implant.

[0050] Features of the expandable body 300 may reduce the likelihood of asymmetric deployment of the implant or provide other beneficial results. Such features may include configuration of a radius of curvature of one or more outer expandable body folds 308 of the expandable body 300. The radius of curvature of the outer expandable body fold 308 may be configured to be half or more of the thickness of the expandable body 300. For example, FIG. 6 shows a close-up view of an outer expandable body fold 308 of the expandable body 300. The radius of curvature 600 of the outer expandable body fold 308 relative to the expandable body thickness 602 is shown to be half or more of the thickness 602 of the expandable body 300.

[0051] The radius of curvature 600 of the outer expandable body folds 308 may be greater than or equal to half the thickness 602 of the expandable body 300 to provide various benefits, including reducing asymmetric deployment of an implant positioned on the exterior surface 306 of the expandable body 300. The radius of curvature 600 of the outer expandable body folds 308 may be greater than or equal to half the thickness 602 of the expandable body 300 during formation of the expandable body 300 (which may include pleating and folding operations on the expandable body 300) when the folds are formed, and / or during compression operations applied to the pleated and foldable expandable body 300, which may form them and / or compress the expandable body 300. For example, pleating and folding and / or compression operations may be applied to generate a radius of curvature 600 of the outer expandable body folds 308 that is provided at half or more of the thickness 602 of the expandable body 300 due to the compressive force or configuration of the pleating and folding operations, among other factors during formation. The radius of curvature 600 of the outer expandable body folds 308 may be half or more of the thickness 602 of the expandable body 300 when the expandable body 300 is inserted into a patient's body and upon deployment of an implant positioned on the exterior surface 306 of the expandable body 300.

[0052] A radius of curvature 600 of the outer inflatable body fold 308 that is half or more of the thickness 602 of the inflatable body 300 may reduce the likelihood of wrinkling of the fold, which may reduce the likelihood of uneven spreading of the fold during expansion of the inflatable body 300. Wrinkling may cause uneven spreading of the fold, for example, because the wrinkling may reduce the likelihood of rotational movement of the fold and may increase the likelihood of undesirable sliding movement of the fold during expansion of the inflatable body. Additionally, a radius of curvature 600 of the outer inflatable body fold 308 that is half or more of the thickness 602 of the inflatable body 300 may reduce the likelihood of hooks, such as hook 506 shown in FIG. 5, which may be undesirable. Additionally, a radius of curvature 600 of the outer inflatable body fold 308 that is half or more of the thickness 602 of the inflatable body 300 may enhance the ability of inflation fluid to pass within the interior of the fold to facilitate symmetric expansion of the inflatable body 300. Various other benefits may be provided.

[0053] The resulting implant 10 may have a greater likelihood of symmetric shape, including height, upon deployment. For example, Figures 4A and 4B show shapes of the implant 10 that may be deployed with an expandable body 300. The body 12 may have a symmetric cylindrical shape as shown in Figures 4A and 4B. The cylindrical shape may, in embodiments, include a uniform outer diameter of the exterior surface 30 of the body 12 and a uniform inner diameter of the interior surface 32. A reduced likelihood of paravalvular leakage and improper coaptation of the leaflets 34 may be provided.

[0054] In embodiments, the configuration of the implant may be varied. The implant may have another shape (e.g., a tapered or "V" shape, or a bulb shape, or other desired shape) and still provide symmetrical deployment. Other configurations of the implant may be utilized as desired.

[0055] Referring again to FIG. 6, other outer expandable body fold radii of curvature may be provided in embodiments. In embodiments, the radius of curvature 600 of the outer expandable body fold 308 may be greater than the thickness 602 of the expandable body 300. In embodiments, the radius of curvature 600 of the outer expandable body fold 308 may be greater than two times the thickness 602 of the expandable body 300. In embodiments, the radius of curvature 600 of the outer expandable body fold 308 may be between one-half the thickness 602 of the expandable body 300 and the thickness 602 of the expandable body 300. Each of the configurations may reduce implant height asymmetry after deployment due to improved ease with which the folds may unfold. Such configurations may reduce fold tightness, fold stiffness, and may reduce fold hooks. Such configurations may include loose loops of the expandable body that may provide such beneficial results.

[0056] In embodiments, at least one of the radii of curvature of the outer inflatable body folds may be configured in this manner. In embodiments, the radii of curvature of a plurality of the outer inflatable body folds may be configured in this manner.

[0057] FIG 3B illustrates a larger size expandable body 305 that may include such an outer expandable body fold radius of curvature. FIG 3C illustrates an even larger size expandable body 307 that may include such an outer expandable body fold radius of curvature. For example, the expandable body 300 of FIG 3A may be configured to deploy a 23 millimeter implant, the expandable body 305 of FIG 3B may be configured to deploy a 26 millimeter implant, and the expandable body 307 of FIG 3C may be configured to deploy a 29 millimeter implant. Other sizes may be utilized in embodiments as desired.

[0058] Other features may be utilized in embodiments herein. For example, referring to FIG. 3A, in embodiments, a lubricious exterior surface 306 may be provided for the expandable body 300. The lubricious exterior surface 306 may be utilized in combination with or in place of the configuration of the radius of curvature of the outer expandable body folds discussed with respect to the expandable body 300. The lubricious exterior surface 306 may be provided to reduce friction between the folds of the expandable body 300 and enhance the ability of the folds to unfold during expansion of the expandable body 300. For example, enhanced rotation of the folds may be provided due to reduced friction of the folds against each other.

[0059] In embodiments, the lubricious exterior surface 306 may have a variety of forms. For example, in embodiments, the lubricious exterior surface 306 may include a lubricious coating on the expandable body 300. In embodiments, the lubricious coating on the exterior surface 306 may be a biocompatible material. Examples of biocompatible lubricious coatings include, but are not limited to, silicone-based lubricants, hydrophilic polymers such as polyvinylpyrrolidone (PVP), PVP / vinyl acetate copolymers, or polyethylene oxide, or other known or yet to be developed biocompatible lubricants. The lubricious coating may be, for example, a fluid coating applied to the exterior surface of the expandable body 300. The lubricious coating may be swabbed onto the exterior surface of the expandable body 300 between the folds of the expandable body 300, or otherwise applied as desired.

[0060] In an embodiment, the lubricious exterior surface 306 may comprise a surface that is thermally bonded to the expandable body. For example, the thermally bonded surface may be a low friction surface provided as an exterior surface of the expandable body 300. In an embodiment, the lubricious exterior surface 306 may comprise a textured surface. For example, the lubricious surface may be created by texturing a surface for low friction applications by making it rougher (stochastic) and then removing any protruding edges. In an embodiment, the textured surface may be provided in a molding process of the expandable body 300, where the mold for the expandable body 300 may include a texture that is applied to the exterior surface during molding of the expandable body. Another method of creating a low friction surface may be to use a porous material where the pores act as reservoirs for the lubricant. In such an example, new pores may appear as the material wears. In an embodiment, the lubricious exterior surface may comprise a bead blasted surface, which may be utilized to provide a textured surface.

[0061] A lubricious exterior surface may be utilized to enhance the ability of the folds of the expandable body 300 to spread relative to one another and reduce the likelihood of them sticking together. In embodiments, the lubricious exterior surface may be positioned between the folds to allow for enhanced spreading. Embodiments such as the expandable bodies 305, 307 shown in Figures 3B and 3C may include the use of a lubricious exterior surface as disclosed herein or other expandable bodies. The lubricious exterior surface may be utilized alone or in combination with any other feature disclosed herein.

[0062] Other features that may be utilized in embodiments herein may include the relationship between the pleat height and the pleat inner diameter of the inflatable body, which may be formed during the pleating and folding operations of the inflatable body.

[0063] 7A, during formation of the expandable body 700, the expandable body 700 may be pleated to form the configuration shown in FIG. 7A. Such pleating action may form the radially extending pleats 702 shown in FIG. 7A. For example, the jaws of a tool may push and deflect into the expandable body 700 to form the pleats 702 shown in FIG. 7A. The tool may be configured to generate a resulting relationship between the pleat height (PH) (708) and the pleat inner diameter (ID) 710 (the diameter formed by the innermost portion of the pleat 702). The tool may be configured to have a jaw depth set to form a resulting relationship between the pleat height 708 and the pleat inner diameter 710, for example.

[0064] In an embodiment, the relationship between pleat height 708 and pleat inner diameter 710 may be formed such that pleat inner diameter 710 is greater than pleat height 708. Such a relationship may increase the radius of curvature of the folds of the outer inflatable body and may result in less tightly packed pleats. The likelihood of pleat hooks (e.g., as shown as hooks 506 in FIG. 5) may be reduced. For example, in one embodiment, pleat inner diameter 710 may be approximately 3.9 millimeters and pleat height 708 may be less than this pleat inner diameter 710, although other pleat inner diameters 710 may be utilized in embodiments. The relationship between pleat height 708 and pleat inner diameter 710 may be maintained in a lower configuration, for example, as shown in 3A-3C and 7B, following a compressing action that compresses pleat 702 shown in FIG. 7A.

[0065] The relationship between pleat height and pleat inner diameter of the inflatable body may be utilized alone or in combination with any other feature disclosed herein.

[0066] Other features that may be utilized in embodiments herein may include a relationship between a compressed outer diameter of the expandable body and an outer diameter of a mandrel positioned within the expandable body. Such a relationship may be formed during a compression operation applied to the expandable body. For example, following a pleating and folding operation of the expandable body, as shown in FIG. 7A, the pleats may be compressed to form a resulting lower configuration, as shown in FIG. 7B and FIGS. 3A-3C, for example. In embodiments, a compression operation may be performed on the expandable body in other ways.

[0067] In the compression operation, a mandrel 709 may be inserted into the inner lumen of the expandable body 700. The expandable body 700 may be formed using the mandrel 709 positioned within the expandable body 700. A compression tool 712 (positioned external to the expandable body 700) may be utilized to apply a radially inward force to the expandable body 700 to compress and lower the pleats 702 to an amount relative to the mandrel 709. In embodiments herein, the ratio of the compressed outer diameter 713 of the expandable body 700 to the outer diameter 711 of the mandrel 709 may be 2.5 or greater. In this manner, the compression tool 712 may compress the pleats 702 to a distance from the outer diameter 711 of the mandrel 709 that corresponds to the ratio of the compressed outer diameter 713 of the expandable body 700 to the outer diameter 711 of the mandrel 709, which may be 2.5 or greater. The relationship of the outer diameter 711 of the mandrel 709 and the compressed outer diameter 713 of the expandable body 700 may be set to loosen the tightness of the pleats and reduce the likelihood of hooks in the pleats (e.g., as shown as hooks 506 in FIG. 5). For example, the compressed outer diameter 713 of the expandable body 700 may be 3.9 millimeters in an embodiment and the outer diameter 711 of the mandrel 709 may be 1.5 millimeters in an embodiment. In an embodiment, other sizes and relationships may be utilized as desired.

[0068] In embodiments, the sheath 714 positioned around the expandable body 700 during the compression operation may affect pleat symmetry. The sheath 714 may comprise shrink tubing or another form of tubing that may have an inner diameter. A smaller starting inner diameter may result in more organized pleats. However, a shrink tubing starting inner diameter that is too large may result in disorganized pleats. The sheath 714 may be removed after the compression operation or may be removed prior to use of the expandable body 700. The mandrel 709 may also be removed prior to use of the expandable body 700 and a lumen may be inserted in its place to expand the expandable body 700, among other features.

[0069] The relationship between the compressed outer diameter 713 of the expandable body 700 and the outer diameter 711 of the mandrel 709 may be utilized alone or in combination with any other feature disclosed herein. For example, a lubricious coating as disclosed herein may be utilized, or the relationship between pleat height and pleat inner diameter as disclosed herein. In embodiments, the configuration of the outer expandable body fold radius of curvature as disclosed herein may be utilized, which may be predetermined for the formation of the expandable body.

[0070] Other features that may be utilized in embodiments herein may include a relationship between an inner diameter 804 of the compression tool 712 and an outer pleat diameter 802 of the pleated expandable body 700. For example, with reference to FIG. 8A, the pleated expandable body 700 may have an outer pleat diameter 802. In FIG. 8B, the pleated expandable body 700 may be inserted into a compression tool 712 having an inner diameter 804 that is larger than the outer pleat diameter 802 of the pleated expandable body 700. Thus, the compression action may reduce the likelihood of hooks forming with the pleats, as shown, for example, in FIG. 8C. The relationship between the inner diameter 804 of the compression tool 712 and the outer pleat diameter 802 of the pleated expandable body 700 may be utilized alone or in combination with any other features disclosed herein.

[0071] Other features that may be utilized in embodiments herein may include compressing the expandable body 700 while rotating the expandable body 700 along an axis from a proximal end of the expandable body 700 to a distal end of the expandable body 700. The axis may comprise a longitudinal axis 717, as depicted in FIGS. 9B and 11. For example, referring to FIG. 9A, a compression tool 712 (e.g., depicted in FIG. 7B) may compress the pleated expandable body 700 while the pleated expandable body 700 is rotated. The pleated expandable body 700 may be rotated in a direction as shown, and the rotation may be relative to the compression tool 712. Rotating the expandable body during compression may reduce the likelihood that hooks will form with the pleats, as depicted in FIG. 9B, for example. For example, rotation of the expandable body during compression may result in looser compression of the expandable body and reduced hook formation. Rotation of the expandable body may be utilized alone or in combination with any other feature disclosed herein.

[0072] The expandable body 700 may otherwise correspond to the expandable body 1058 shown in FIG. 11. For example, the expandable body 700 may be configured similarly to the expandable body 1058 shown in FIG. 11. The folds or pleats of the expandable body 700 may correspond to the folds 1084 or pleats shown in FIG. 11. The inner shaft 715 shown in FIG. 8C may correspond to the inner shaft 1068 shown in FIG. 11. The expandable body 700 may be coupled to a delivery device and expand or contract in a manner similar to the expandable body 1058 shown in FIG. 11. Similar to the expandable body 1058 shown in FIG. 11, the expandable body 700 may have a proximal end and a distal end and a central body having a length positioned between the proximal and distal ends. The central body may be configured to push against an inner surface of the implant to expand the implant.

[0073] In operation, the formed expandable body may be coupled to a delivery apparatus and may include an expansion device for the implant. The expansion device may be inserted into the body. The implant may be positioned on the expansion device prior to entering the patient's body, or may be positioned on the expansion device within the patient's body.

[0074] The implant may be expanded and deployed to a desired portion of the patient's body utilizing an expansion device. For example, with reference to Figures 10 and 11, with the implant 10 in a desired location within the patient's body, such as proximal to an implantation site, fluid may be flowed, for example, through fluid port 1062 to expand the expandable body. The expandable body may expand radially outward to an expanded, deployed, expanded, or uncompressed configuration, where the diameter of the expandable body increases and the implant 10 expands radially outward and is deployed. The expansion device may be configured according to any of the embodiments of expansion devices disclosed herein. Other methods according to embodiments herein may be utilized.

[0075] The implant may comprise a prosthetic heart valve and may be deployed to the heart valve. The delivery device may be advanced through the vascular system of the patient's body, for example, to approach the heart valve. The delivery device may be deflected via a control mechanism or other device to direct the delivery device to the implantation site. The expansion device may be expanded or inflated to deploy the implant at the implantation site.

[0076] In embodiments where the implant is deployed at the aortic valve, the delivery device may approach the native aortic valve via the aortic arch. Other approaches (e.g., ventricular approach) may be utilized as desired. The elongated shaft of the delivery device may pass through the vascular system with the handle remaining outside the patient's body. An implant in the form of a prosthetic aortic valve may be deployed at the aortic valve. Other implantation sites may be utilized, such as the mitral, pulmonary, or tricuspid valves. Other implantation sites within the heart or within the patient's body may be utilized. Various forms of implants may be utilized, which may comprise medical implants for the treatment of the patient's body, prosthetic heart valves or stents, or other forms of implants.

[0077] Features of the embodiments may be modified, substituted, omitted or combined.

[0078] Additionally, the methods herein are not limited to the methods specifically described, but may include methods utilizing the systems and devices disclosed herein.

[0079] Method steps may be modified, removed, or added using the systems, apparatus, and methods disclosed herein.

[0080] Features of the embodiments disclosed herein may be implemented independently of the delivery device or independently of the other components disclosed herein. Various devices of the system may be implemented independently.

[0081] In summary, although aspects of the present specification are highlighted by reference to specific embodiments, it will be understood that those skilled in the art will readily recognize that these disclosed embodiments are merely illustrative of the principles of the subject matter disclosed herein. Thus, it should be understood that the disclosed subject matter is in no way limited to the specific methodology, protocols, and / or reagents, etc. described herein. Thus, various modifications or variations of the subject matter disclosed herein, or alternative configurations, can be made in accordance with the teachings herein without departing from the spirit of the present specification. Finally, the terms used herein are for the purpose of describing only specific embodiments, and are not intended to limit the scope of the systems, devices, and methods as disclosed herein, which are defined only by the claims. Thus, the systems, devices, and methods are not limited to the precise manner as shown and described.

[0082] Certain embodiments of the systems, devices, and methods are described herein, including the best mode known to the inventors for carrying them out. Of course, variations of these described embodiments will become apparent to those of ordinary skill in the art upon reading the above description. The inventors expect those of ordinary skill in the art to adopt such variations as appropriate, and the inventors contemplate the systems, devices, and methods being practiced otherwise than as specifically described herein. Accordingly, the systems, devices, and methods include all modifications and equivalents of the subject matter recited in the claims appended hereto as permitted by applicable law. Moreover, any combination of the above-described embodiments in all possible variations thereof is encompassed by the systems, devices, and methods unless otherwise indicated herein or clearly contradicted by context.

[0083] Groupings of alternative embodiments, elements, or steps of systems, devices, and methods are not to be construed as limitations. Each group member may be referred to and claimed individually or in any combination with other group members disclosed herein. It is anticipated that one or more members of a group may be included in, or deleted from, a group for reasons of convenience and / or patentability. When such inclusions or deletions occur, the specification will be deemed to contain the modified group and thus satisfy the description of all Markush groups used in the appended claims.

[0084] Unless otherwise indicated, all numbers expressing features, items, quantities, parameters, properties, terms, etc. used in the specification and claims are to be understood in all instances as being modified by the term "about." As used herein, the term "about" means that the feature, item, quantity, parameter, property, or term so modified encompasses approximations that may vary, but still be able to perform the desired operation or process discussed herein.

[0085] The terms "a," "an," "the," and similar references used in the context of describing systems, devices, and methods (particularly in the context of the claims below) shall be construed as covering both the singular and the plural, unless otherwise indicated herein or clearly contradicted by context. All methods described herein may be performed in any suitable order, unless otherwise indicated herein or clearly contradicted by context. The use of any and all examples or exemplary language (e.g., "such as") provided herein is intended merely to better illuminate the systems, devices, and methods, and does not pose a limitation on the scope of the systems, devices, and methods otherwise claimed. No language in this specification should be construed as indicating any non-claimed element essential to the practice of the systems, devices, and methods.

[0086] All patents, patent publications, and other publications referenced and identified in this specification are individually and expressly incorporated herein by reference in their entirety for the purpose of describing and disclosing the compositions and methodologies described in such publications that may be used in connection with, for example, the systems, apparatus, and methods. These publications are provided solely for their disclosure prior to the filing date of this application. Nothing in this regard should be construed as an admission that the inventors are not entitled to antedate such disclosure by reason of prior invention or for any other reason. All statements as to the date or representation as to the contents of these documents are based on the information available to the applicants and do not constitute an admission as to the accuracy of the dates or contents of these documents.

Claims

1. 1. An expansion device for an implant, comprising:

1. An expansion device comprising: an expandable body having a proximal end and a distal end; and a central body having a length positioned between the proximal end and the distal end, the central body configured to press against an inner surface of the implant to expand the implant, the expandable body including at least one outer expandable body fold radius of curvature that is greater than or equal to half the thickness of the expandable body.

2. The expansion device of claim 1 , wherein a radius of curvature of the at least one outer expandable body fold is greater than the thickness of the expandable body.

3. 3. The expansion device of claim 1 or 2, wherein a radius of curvature of the at least one outer expandable body fold is greater than twice the thickness of the expandable body.

4. The expansion device of claim 1 , wherein the radius of curvature of the at least one outer expandable body fold is between 1 and 5 times the thickness of the expandable body.

5. The expansion device of claim 1 , wherein a radius of curvature of the at least one outer expandable body fold is between half the thickness of the expandable body and the thickness of the expandable body.

6. The expansion device of any one of claims 1 to 5, wherein the expandable body includes an internal lumen for fluid flow.

7. The expansion device of any one of claims 1 to 6, wherein the expandable body comprises a plurality of folds.

8. The expansion device of claim 7 , wherein the plurality of folds are configured to unfold during expansion of the expandable body.

9. The expansion device of any one of claims 1 to 8, wherein the diameter of the expandable body increases as the expandable body expands.

10. The expansion device of any one of claims 1 to 9, wherein the expandable body includes a distal shoulder.

11. The expansion device of claim 10 , wherein the central body is positioned proximal to the distal shoulder and includes an implant holding area.

12. The expansion device of any one of claims 1 to 11, wherein the expandable body comprises a lubricious outer surface.

13. The expansion device of any one of claims 1 to 12, wherein the expandable body is configured to couple to a delivery device for the implant.

14. The expansion device of any one of claims 1 to 13, wherein the expandable body comprises a balloon.

15. The expansion device of any one of claims 1 to 14, wherein the expandable body is formed by a pleating and folding operation.

16. The expansion device of claim 15 , wherein the expandable body is formed by a compression action applied to the expandable body after the pleating and folding actions.

17. The expansion device of any one of claims 1 to 16, wherein the expandable body has an inner pleat diameter that is greater than the pleat height.

18. 18. The expansion device of any one of claims 1 to 17, wherein the expandable body is formed using a mandrel positioned within the expandable body, and the ratio of the compressed outer diameter of the expandable body to the outer diameter of the mandrel is 2.5 or greater.

19. The expansion device of any one of claims 1 to 18, wherein the implant comprises a prosthetic heart valve.

20. The expansion device of any one of claims 1 to 19, wherein the implant comprises a prosthetic aortic valve.

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