Delivery cathethers with reduced retrieval forces

Abstract

The present systems and methods relate to devices, systems, and methods for expansion of implants and retrieval of devices for expanding implants. Inflatable bodies such as balloons may have reduced retrieval forces through a sheath in vivo. The reduced retrieval force may be produced by reducing a total amount of material forming the respective proximal end portions and distal end portions of the inflatable bodies. Organized folding patterns of the inflatable bodies may reduce the force of retrieval or retraction into a sheath in vivo.

Description

DELIVERY CATHETHERS WITH REDUCED RETRIEVAL FORCESCROSS REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Application No. 63 / 627,675, filed January 31, 2024, the entire contents of which is hereby incorporated by reference.BACKGROUND OF THE INVENTION

[0002] A variety of maladies may affect an individual’s body. Such maladies may be of the individual’s heart, and may include maladies of the individual’s heart valves, including the aortic, mitral, tricuspid, and pulmonary valves. Stenosis, for example, is a common and serious valve disease that may affect the operation of the heart valves and an individual’s overall wellbeing.

[0003] Implants may be provided that may replace or repair portions of a patient’s heart. Prosthetic implants, such as prosthetic heart valves, may be provided to replace a portion of a patient’s heart. Prosthetic aortic, mitral, tricuspid, and even pulmonary valves may be provided.

[0004] Implants may be deployed to the desired portion of the patient’s body percutaneously, in a minimally invasive manner. Such deployment may occur transcatheter, in which a catheter may be deployed through the vasculature of an individual.

[0005] During deployment of such implants, the implants can be dilated to provide an expanded configuration for such implant. Care must be taken to property dilate the implants to avoid over expansion or under expansion of such implants and to properly deploy such an implant. Further, the dilation devices utilized to dilate the implants often must be retrieved from the vasculature of the patient following deployment of the implant.SUMMARY

[0006] The present systems and methods relate to devices, systems, and methods for expansion of implants and retrieval of devices for expanding implants. Such devices, systems, and methods may include inflatable bodies configured to be inflated to expand the implant.

[0007] Devices, systems, and methods disclosed herein may include inflatable bodies (e.g., balloons) having reduced retrieval forces through a sheath in vivo. The reduced retrieval force may be produced by reducing a total amount of material forming the respective proximal end portions and distal end portions of the inflatable bodies. Further, organized folding patterns of the inflatable bodies may reduce the force of retrieval or retraction into a sheath in vivo.

[0008] Examples as disclosed herein include a delivery system for an expandable implant, the delivery system including a delivery catheter configured to deliver the expandable implant to a location in a patient’s body. The delivery catheter may include an elongate catheter shaft having a longitudinal axis. The delivery catheter may include an inflatable body coupled to the elongate catheter shaft and surrounding a chamber for receiving fluid for inflation of the inflatable body. The inflatable body may include a central portion configured to press an interior surface of the implant to expand the implant, the central portion having a proximal end and a distal end and a length between the proximal end and the distal end. The inflatable body may include a proximal end portion joined to the proximal end of the central portion, the proximal end portion including at least a first segment and a second segment that is positioned proximal of the first segment, the first segment and the second segment each being angled radially outward from the longitudinal axis, the first segment having a greater angle relative to the longitudinal axis than the second segment. The inflatable body may include a distal end portion joined to the distal end of the central portion, the distal end portion including at least a first segment and a second segment that is positioned distal of the first segment of the distal end portion, the first segment of the distal end portion and the second segment of the distal end portion each being angled radially outward from the longitudinal axis, the first segment of the distal end portion having a greater angle relative to the longitudinal axis than the second segment of the distal end portion.

[0009] Examples as disclosed herein include a method including expanding an implant at an implantation site within a patient’s body utilizing an inflatable body, the implant being positioned upon the inflatable body and the inflatable body being coupled to an elongate catheter shaft and surrounding a chamber for receiving fluid for inflation of the inflatable body. The inflatable body may include a central portion configured to press an interior surface of the implant to expand the implant, the central portion having a proximal end and a distal end and a length between the proximal end and the distal end. The inflatable body may include a proximal end portion joined to the proximal end of the central portion, the proximal end portion including at least a first segment and a second segment that is positioned proximal of the firstsegment, the first segment and the second segment each being angled radially outward from a longitudinal axis of the elongate catheter shaft, the first segment having a greater angle relative to the longitudinal axis than the second segment. The inflatable body may include a distal end portion joined to the distal end of the central portion, the distal end portion including at least a first segment and a second segment that is positioned distal of the first segment of the distal end portion, the first segment of the distal end portion and the second segment of the distal end portion each being angled radially outward from the longitudinal axis, the first segment of the distal end portion having a greater angle relative to the longitudinal axis than the second segment of the distal end portion.BRIEF DESCRIPTION OF THE DRAWINGS

[0010] These and other features, aspects, and advantages are described below with reference to the drawings, which are intended to illustrate, but not to limit, the disclosure. In the drawings, like reference characters denote corresponding features consistently throughout similar examples.

[0011] FIG. 1 is a perspective view of an implant.

[0012] FIG. 2 is a top view of the implant shown in FIG. 1 with leaflets in a closed configuration.

[0013] FIG. 3 is a top view of the implant shown in FIG. 1 with leaflets in an open configuration.

[0014] FIG. 4 is a side view of a delivery catheter.

[0015] FIG. 5 is a detail view of the distal end of the delivery catheter shown in FIG. 4.

[0016] FIG. 6 is a perspective view of an inflatable body.

[0017] FIG. 7 is a side cross sectional view of the inflatable body shown in FIG. 6, with the inflatable body positioned upon an elongate catheter shaft.

[0018] FIG. 8 is a perspective view of an inflatable body.

[0019] FIG. 9 is a side cross sectional view of the inflatable body shown in FIG. 8 along line A- A, with the inflatable body positioned upon an elongate catheter shaft.

[0020] FIG. 10 is a side cross sectional view of the inflatable body shown in FIG. 8 along line B-B, with the inflatable body positioned upon an elongate catheter shaft.

[0021] FIG. 11 is a transverse cross sectional view of the inflatable body shown in FIG. 8 along line C-C, with the inflatable body positioned upon an elongate catheter shaft.

[0022] FIG. 12 is a transverse cross sectional view of the inflatable body shown in FIG. 8 in a deflated state, with the inflatable body positioned upon an elongate catheter shaft.

[0023] FIG. 13 is a perspective view of the inflatable body shown in FIG. 8 in a partially deflated state.

[0024] FIG. 14 is a schematic view of a delivery catheter approaching an aortic valve.

[0025] FIG. 15 is a schematic view of a delivery catheter expanding an implant at the aortic valve.

[0026] FIG. 16 is a side cross sectional view of a sheath.

[0027] FIG. 17A is a side view of retraction of a deflated inflatable body into the sheath shown in FIG. 16.

[0028] FIG. 17B is a side view of retraction of a deflated inflatable body into the sheath shown in FIG. 16.

[0029] FIG. 18 is a perspective view of an inflatable body.

[0030] FIG. 19 is a side cross sectional view of an inflatable body as shown in FIG. 18 positioned upon an elongate catheter shaft.

[0031] FIG. 20 is a chart of retrieval force.DETAILED DESCRIPTION

[0032] FIG. 1 illustrates a perspective view of an implant 10 in the form of a prosthetic heart valve. The implant 10 may be configured to be deployed within a portion of a patient’s body. The implant 10, for example, may be deployed within a native heart valve annulus, which may comprise a native aortic valve, or in examples may comprise a native mitral, tricuspid, or pulmonary valve. In examples, the implant 10 may have other forms, and may comprise a stent or other form of medical implant as desired.

[0033] The implant 10 may include a proximal end 12 and a distal end 14, and a length therebetween. The implant 10 may include a body in the form of a frame 16. The implant 10 may further include one or more of a plurality of leaflets 18a-c coupled to the frame 16 and may include a skirt 20 covering an outer surface of a distal portion of the frame 16.

[0034] The frame 16 may comprise a plurality of struts 22 connected at junctures 24. A plurality of openings 26 may be positioned between the struts 22. The openings 26 may be configured to reduce the overall weight of the frame 16, and also allow the frame 16 to be compressed to reduce a diameter of the frame 16 and be expanded to increase a diameter of the frame 16. The frame 16 may be configured to be radially compressed and axially lengthened while being radially compressed. The struts 22 may be configured such that as the frame 16 is compressed to reduce a diameter of the frame 16, the length of the frame 16 may increase. Also, as the frame 16 is expanded to increase the diameter of the frame 16, the length of the frame 16 may decrease. The frame 16 may be compressed in a variety of manners, including use of a crimping device, and may be expanded in a variety of manners, including being expanded with an inflatable body such as a balloon. Examples herein may refer to a balloon expandable implant.

[0035] The frame 16 may include an outer surface 28 configured to be pressed against an interior vasculature of a patient’s body. For example, as the frame 16 is expanded, the outer surface 28 may contact and press against the interior vasculature of the patient’s body. The outer surface 28 may press against a native annulus, or native leaflets of a heart valve in examples. The frame 16 may include an interior surface 30 (marked in FIG. 2) configured to face opposite the outer surface 28 and configured to face towards a flow channel of the implant 10.

[0036] The skirt 20 may cover the outer surface 28 of the distal portion of the frame 16 as shown in FIG. 1 and may comprise a membrane or other form of skirt 20. The skirt 20 may improve compliance of the frame 16 with a native valve in which the implant 10 is implanted and may be utilized to couple the leaflets 18a-c to the frame 16 via sutures of another form of coupler.

[0037] The plurality of leaflets 18a-c (more clearly shown in FIG. 2) may extend inward from the interior surface 30 of the frame 16. The plurality of leaflets 18a-c may be configured to move towards each other to move to a closed position (as shown in FIG. 2) and be moved away from each other to move to an open position (as shown in FIG. 3). The leaflets 18a-cmay each include upper end portions 32a-c (marked in FIG. 3) that are configured to contact each other to close the flow channel of the implant 10 when the leaflets 18a-c are in the closed position. The upper end portions 32a-c are configured to move away from each other to open the flow channel of the implant 10 when the leaflets 18a-c are in the open position. The leaflets 18a-c may move back and forth between open and closed positions or states or configurations to replicate the motion of a native valve.

[0038] Each leaflet 18a-c may include an interior surface 34a-c (marked in FIG. 3) configured to face towards the flow channel of the implant 10, and an exterior surface 36a-c (marked in FIG. 2) facing opposite the interior surface 34a-c and facing away from the flow channel 37 of the implant 10. Portions of the interior surface 34a-c of respective leaflets 18a- c may contact each other when the leaflets 18a-c move to the closed position.

[0039] Each leaflet 18a-c may include a respective outer portion 38a-c (marked in FIG. 2) that couples to the frame 16 of the implant 10. The coupling may have a variety of forms. For example, each leaflet 18a-c may include tabs 40a-f at the respective outer portion 38a-c of the leaflet 18a-c. The tabs 40a, b may extend from the leaflet 18a, the tabs 40c, d may extend from the leaflet 18b, and the tabs 40e, f may extend from the leaflet 18c. The tabs 40a-f may extend through openings in the frame 16 to couple to the frame 16 and then may be sutured to hold the tabs 40a-f in position. The tabs 40a-f may form commissures of adjacent leaflets 18a-c.

[0040] Further, the outer portion 38a-c of each leaflet 18a-c may be sutured to the skirt 20 along a suture line 42a-c. For example, a lower end portion of each leaflet 18a-c opposite the upper end portion 32a-c may be sutured to the skirt 20 at a respective suture line 42a-c. The sutures of the suture line 42a-c may hold the leaflets 18a-c to the frame 16 and prevent undesired fluid flow through the implant 10 outside of the flow channel 37.

[0041] The leaflets 18a-c may be configured to open and close during operation such that the proximal end 12 of the implant 10 forms an outflow end of the implant 10, and the distal end 14 of the implant 10 forms an inflow end of the implant 10. The leaflets 18a-c may be configured to impede fluid flow in an opposite direction from the outflow end to the inflow end of the implant 10 when the leaflets 18a-c are in a closed position.

[0042] In examples, other forms of implants may be utilized, such as stents or other forms of medical devices. The configuration of the implant shown in FIGS. 1-3 may be varied in examples.

[0043] The implant 10 may be configured to be delivered to an implantation site utilizing a delivery system. FIG. 4, for example, illustrates an example of a delivery system 43 that may be utilized to deliver the implant 10 to a desired implantation site. The delivery system 43 may include a delivery catheter 44. The delivery catheter 44 is configured to deliver the expandable implant 10 to a location within a patient’s body (e.g., the desired implantation site). The delivery catheter 44 may include an elongate catheter shaft 46 having a distal portion 48 and a proximal portion 50. The proximal portion 50 may couple to a housing in the form of a handle 52. The distal portion 48 may include an implant retention area 54 and a distal tip that may include a nose cone 56. The distal portion 48 may further include an inflatable body 58.

[0044] The handle 52 may be configured for a user to grip to operate the delivery catheter 44 and to maneuver the delivery catheter 44 through the vasculature of the patient’s body. For example, the handle 52 may be moved distally to advance the elongate catheter shaft 46 distally within the patient’s body and may be moved proximally to retract the elongate catheter shaft 46 proximally within the patient’s body. As such, the implant retention area 54 and accordingly the implant 10 may be moved and positioned with the operation of the handle 52.

[0045] A control mechanism 60 may further be coupled to the handle 52. The control mechanism 60 may be configured to be operated to bend the elongate catheter shaft 46 as desired. For example, one or more pull tethers may extend along the elongate catheter shaft 46 and operation of the control mechanism 60 may push or pull the one or more pull tethers to cause the elongate catheter shaft 46 to bend. The bending of the elongate catheter shaft 46 accordingly may be controlled by the control mechanism 60. As shown in FIG. 4, the control mechanism 60 may comprise a rotatable body in the form of a control knob that may be rotated to push or pull the pull tether and cause the elongate catheter shaft 46 to bend. Other forms of control mechanisms may be utilized as desired.

[0046] A fluid port 62 may further be coupled to the handle 52 and may be utilized to transfer fluid to and from the inflatable body 58 as desired. The configuration of the handle 52 may be varied in other examples as desired.

[0047] FIG. 5 illustrates a close-up view of the distal portion 48 of the elongate catheter shaft 46. The elongate catheter shaft 46 extends along a longitudinal axis 71. The elongate catheter shaft 46 may include an interior portion 68 or interior shaft portion that extends interior of the inflatable body 58 in examples, and may include a portion 66 or proximal shaft portion that is not interior of the inflatable body 58 and is positioned proximal of the portion 68. Theportion 66 may be proximal of the inflatable body 58. The elongate catheter shaft 46, in examples, may include a fluid conduit or inflation lumen 69 (marked in FIG. 7) that extends along the elongate catheter shaft 46. The inflation lumen 69 allows fluid to be passed into and out of the inflatable body 58 for inflating and deflating the inflatable body 58 respectively. The elongate catheter shaft 46 may include one or more other shafts in examples.

[0048] The interior portion 68 or interior shaft portion may further comprise a distal shoulder 70 that may be positioned distal of the implant retention area 54. The distal shoulder 70 comprises a portion of the delivery catheter 44 positioned distal of the implant retention area 54, along with other portions such as the distal tip including a nose cone 56 and a distal end portion 72 of the inflatable body 58. The nose cone 56 may be coupled to the elongate catheter shaft 46 distal of the inflatable body 58. The distal shoulder 70 may protrude radially outward from the interior portion 68 and may have a conical shape as desired. The taper of the conical shape may be configured such that the size of the distal shoulder 70 increases in a proximal direction towards the implant retention area 54. The distal shoulder 70 may be configured to protect an implant 10 positioned within the implant retention area 54 as the elongate catheter shaft 46 is advanced through the patient’s body. For example, an outer diameter of the distal shoulder 70 may be at or greater than a diameter of the implant 10 when the implant 10 is in a crimped state, thus shielding the leading edge (such as the distal end 14 of the implant 10) from contacting a portion of the patient’s body or snagging or snaring on a sheath that the elongate catheter shaft 46 may be advanced through.

[0049] In examples, the interior portion 68 may include a shoulder that is proximal of the implant retention area 54. A proximal shoulder 77 of the inflatable body 58 may extend over the proximal shoulder of the interior portion 68 in such an example. The implant retention area 54 may have a length 81, which may be a distance between the distal shoulder 70 and the proximal shoulder 77.

[0050] The inflatable body 58 is shown in FIG. 5 in a deflated state, without an implant crimped or otherwise coupled to the inflatable body 58. FIG. 6 illustrates a perspective view of the inflatable body 58 in an inflated state and FIG. 7 illustrates a cross sectional view of the inflatable body 58 coupled to the elongate catheter shaft 46. The inflatable body 58 surrounds a chamber 73 for receiving fluid for inflation of the inflatable body 58. The chamber 73 may receive fluid from a fluid conduit or inflation lumen 69 for inflation of the inflatable body 58. The fluid, for example, may pass from a fluid port 62 as shown in FIG. 4 through the inflationlumen 69, and through a port 79 of the inflation lumen 69 in examples. The fluid passes into the chamber 73 for inflating the inflatable body 58. To withdraw fluid, the fluid may be withdrawn in a reverse manner through the inflation lumen 69 to deflate the inflatable body 58.

[0051] Referring to FIG. 6, the inflatable body 58 may include a central portion 74. The central portion 74 may be configured to press an interior surface of the implant 10 to expand the implant 10. The central portion 74 may comprise the implant retention area 54 as shown in FIG. 5 for example. The implant 10 may surround the central portion 74, with the interior surface 30 of the implant 10 contacting the central portion 74 upon being crimped to the central portion 74. The central portion 74 is positioned within the flow channel 37 as shown in FIG. 3. The central portion 74 may extend from a proximal end 76 to a distal end 78, with a length 80 (marked in FIG. 7) between the proximal end 76 and the distal end 78.

[0052] In examples, the central portion 74 may have a cylindrical shape as shown in FIG. 6. The central portion 74 may have a uniform diameter 75 from the proximal end 76 of the central portion 74 to the distal end 78 of the central portion 74, as shown in the cross sectional view of FIG. 7. The uniform diameter may press uniformly against the interior surface of the implant 10 upon inflation of the inflatable body 58.

[0053] A proximal end portion 82 of the inflatable body 58 may be joined to the proximal end 76 of the central portion 74. The proximal end portion 82 may include a plurality of segments in examples. The segments may include at least a first segment 84 and a second segment 86 positioned proximal of the first segment 84.

[0054] The first segment 84 and the second segment 86 may each be angled radially outward from the longitudinal axis 71. The second segment 86 may angle radially outward in a distal direction, such that a proximal end 88 of the second segment 86 has a smaller diameter than a distal end 90 of the second segment 86. The second segment 86 may have a conical shape from the proximal end 88 or inner end of the second segment 86 to the distal end 90 or outer end of the second segment 86. The second segment 86 may have other shapes in examples.

[0055] In examples, the second segment 86 may extend at a single angle, or may have an invariant angle from the proximal end 88 to the distal end 90 as shown in FIG. 7 for example. The angle 91 may be such that the angle of the second segment 86 is discontinuous with the proximal end 76 of the central portion 74. Such a configuration differs from a configurationas shown in FIGS. 18 and 19, in which the angle of the proximal end portion 272 is continuous with the proximal end 274 of the central portion 276.

[0056] The first segment 84 extends at a greater angle relative to the longitudinal axis 71 than the second segment 86. The first segment 84, for example, may extend at a perpendicular angle relative to the longitudinal axis 71. The angle of the first segment 84 may form a radial offset from the distal end 90 of the second segment 86 to the proximal end 76 of the central portion 74. The angle of the first segment 84 may be a single angle in examples. The first segment 84 may extend from an inner end 92 of the first segment 84 to an outer end 94 of the first segment 84 that joins with the proximal end 76 of the central portion 74. The first segment 84 may form a ring or a flat disk extending around the distal end 90 of the second segment 86 as shown in FIG. 6 for example. The ring or flat disk joins the second segment 86 of the proximal end portion 82 to the proximal end 76 of the central portion 74 and comprises a flange protruding radially outward. The ring or flat disk may have a radius of between 2 millimeters and 4 millimeters (and may be 3 millimeters, producing a diameter offset of 6 millimeters), although lesser or greater amounts may be utilized as desired. The distal end 90 of the second segment 86 is discontinuous and lacks a smooth transition with the proximal end 76 of the central portion 74. The distal end 90 of the second segment 86 is offset radially inward of the proximal end 76 of the central portion 74.

[0057] The proximal end portion 82 of the inflatable body 58 may include a third segment 100 in examples, which may extend at a lesser angle than the second segment 86 or the first segment 84. The third segment 100 may extend parallel with the longitudinal axis 71 in examples and may have a cylindrical shape. The third segment 100 may couple with the elongate catheter shaft 46 in examples.

[0058] A distal end portion 72 of the inflatable body 58 may be joined to the distal end 78 of the central portion 74. The distal end portion 72 may include a plurality of segments in examples. The segments may include at least a first segment 110 and a second segment 112 positioned distal of the first segment 110.

[0059] The first segment 110 and the second segment 112 may each be angled radially outward from the longitudinal axis 71. The second segment 112 may angle radially outward in a proximal direction, such that a distal end 114 of the second segment 112 has a smaller diameter than a proximal end 116 of the second segment 112. The second segment 112 may have a conical shape from the proximal end 116 or outer end of the second segment 112 to thedistal end 114 or inner end of the second segment 112. The second segment 112 may have other shapes in examples.

[0060] In examples, the second segment 112 may extend at a single angle, or may have an invariant angle from the proximal end 116 to the distal end 114 as shown in FIG. 7 for example. The angle may be such that the angle of the second segment 112 is discontinuous with the distal end 78 of the central portion 74. Such a configuration differs from a configuration as shown in FIGS. 18 and 19, in which the angle of the distal end portion 278 is continuous with the distal end 280 of the central portion 276.

[0061] The first segment 110 extends at a greater angle relative to the longitudinal axis 71 than the second segment 112. The first segment 110, for example, may extend at a perpendicular angle relative to the longitudinal axis 71. The angle of the first segment 110 may form a radial offset from the proximal end 116 of the second segment 112 to the distal end 78 of the central portion 74. The angle of the first segment 110 may be a single angle in examples. The first segment 110 may extend from an inner end 118 of the first segment 110 to an outer end 120 of the first segment 110 that joins with the distal end 78 of the central portion 74. The first segment 110 may form a ring or a flat disk extending around the proximal end 116 of the second segment 112, similar to the second segment 86 shown in FIG. 6 for example. The ring or flat disk joins the second segment 1 12 of the distal end portion 72 to the distal end 78 of the central portion 74 and comprises a flange protruding radially outward. The ring or flat disk may have a radius of between 2 millimeters and 4 millimeters (and may be 3 millimeters, producing a diameter offset of 6 millimeters), although lesser or greater amounts may be utilized as desired. The proximal end 116 of the second segment 112 is discontinuous and lacks a smooth transition with the distal end 78 of the central portion 74. The proximal end 116 of the second segment 112 is offset radially inward of the distal end 78 of the central portion 74.

[0062] The distal end portion 72 of the inflatable body 58 may include a third segment 130 in examples, which may extend at a lesser angle than the second segment 112 or the first segment 110. The third segment 130 may extend parallel with the longitudinal axis 71 in examples and may have a cylindrical shape. The third segment 130 may couple with the elongate catheter shaft 46 in examples.

[0063] The radial offset formed by the respective second segments 86, 112 may reduce the total amount of material forming the respective proximal end portion 82 and distal end portion 72 of the inflatable body 58 as compared with an inflatable body 270 as shown in FIGS. 18 and19. With the inflatable body 270 as shown in FIGS. 18 and 19, such an offset may be excluded and the respective proximal end portion 272 and distal end portions 278 may extend to the outer surface of the central portion 276 at a single angle. A reduction in the total amount of material (e.g., a radially inward offset as shown in FIGS. 6 and 7) may reduce a retraction force of the inflatable body 58 through a sheath as compared with an inflatable body 270 as shown in FIGS. 18 and 19.

[0064] Variations in the configuration of the inflatable body may be provided in examples. FIG. 8, for example, illustrates a variation of an inflatable body 150 in an inflated state, with FIG. 9 comprising a cross sectional view along line A-A and FIG. 10 comprising a cross sectional view along line B-B (with the elongate catheter shaft 46 illustrated in FIGS. 9 and 10).

[0065] Referring to FIG. 8, the inflatable body 150 may include a central portion 152. The central portion 152 may be configured to press an interior surface of the implant 10 to expand the implant 10. The implant 10 may surround the central portion 152, with the interior surface 30 of the implant 10 contacting the central portion 152 upon being crimped to the central portion 152. The central portion 152 is positioned within the flow channel 37 as shown in FIG. 3. The central portion 152 may extend from a proximal end 154 to a distal end 156, with a length 158 (marked in FIG. 9) between the proximal end 154 and the distal end 156.

[0066] In examples, the central portion 152 may have a rectangular shape as shown in FIG. 8. The central portion 152 may be shape set or formed with the rectangular shape. The central portion 152 may have a square cross-sectional profile transverse or orthogonal to the longitudinal axis 71 (as represented in FIG. 11).

[0067] The central portion 152 may include four longitudinally extending outer side surfaces 160a-d that may join to each other at edges or longitudinally extending juncture lines 162a-d. Each of the side surfaces 160a-d may include a respective mid portion 164a-d.

[0068] The central portion 152 may have a uniform diameter 166 from the proximal end 154 of the central portion 152 to the distal end 156 of the central portion 152, as shown in the cross sectional view of FIG. 9. The diameter 166 across the mid portions 164a-d of the respective side surfaces 160a-d may be less than the largest diagonal diameter 168 (marked in FIG. 10) across the respective edges or longitudinally extending juncture lines 162a-d of the central portion 152. In examples, the fluid pressure within the chamber 169 of the inflatable body 150 may cause the side surfaces 160a-d to bow outward to contour to a cylindrical innershape of an implant 10. The inflatable body 150, however, may be shape set or formed with a shape as shown in FIGS. 8-11.

[0069] A proximal end portion 170 of the inflatable body 150 may be joined to the proximal end 154 of the central portion 152. The proximal end portion 170 may include a plurality of segments in examples. The segments may include at least a first segment 172 and a second segment 174 positioned proximal of the first segment 172.

[0070] The first segment 172 and the second segment 174 may each be angled radially outward from the longitudinal axis 71. The second segment 174 may angle radially outward in a distal direction, such that a proximal end 176 of the second segment 174 has a smaller diameter than a distal end 178 of the second segment 174. The second segment 174 may have a conical shape from the proximal end 176 or inner end of the second segment 174 to the distal end 178 or outer end of the second segment 174. The second segment 174 may have other shapes in examples (e.g., other polygon shapes).

[0071] In examples, the second segment 174 may extend at a single angle, or may have an invariant angle from the proximal end 176 to the distal end 178 as shown in FIG. 9 for example.

[0072] The first segment 172 extends at a greater angle relative to the longitudinal axis 71 than the second segment 174. The first segment 172, for example, may extend at a perpendicular angle relative to the longitudinal axis 71. The angle of the first segment 172 may form a radial offset from the distal end 178 of the second segment 174 to the proximal end 154 of the central portion 152. The angle of the first segment 172 may be a single angle in examples. The first segment 172 may extend from an inner end 180 of the first segment 172 to an outer end 182 of the first segment 172 that joins with the proximal end 154 of the central portion 152. The first segment 172 may form a plurality of wedges extending around the distal end 178 of the second segment 174 as shown in FIG. 8 for example. The wedges may be positioned at the comers outside of the circumference of the distal end 178 of the second segment 174. The wedges comprise a plurality of flanges extending radially outward. Each wedge may have a radius of between 2 millimeters and 4 millimeters (and may be 3 millimeters, producing a diameter offset of 6 millimeters), although lesser or greater amounts may be utilized as desired. The wedges join the second segment 174 of the proximal end portion 170 to the proximal end 154 of the central portion 152. The distal end 178 of the second segment 174 is offset radially inward of the proximal end 154 of the central portion 152 at the wedges.

[0073] The proximal end portion 170 of the inflatable body 150 may include a third segment 190 in examples, which may extend at a lesser angle than the second segment 174 or first segment 172. The third segment 190 may extend parallel with the longitudinal axis 71 in examples and may have a cylindrical shape. The third segment 190 may couple with the elongate catheter shaft 46 in examples.

[0074] A distal end portion 200 of the inflatable body 150 may be joined to the distal end 156 of the central portion 152. The distal end portion 200 may include a plurality of segments in examples. The segments may include at least a first segment 202 (marked in FIG. 10) and a second segment 204 positioned distal of the first segment 202.

[0075] The first segment 202 and the second segment 204 may each be angled radially outward from the longitudinal axis 71. The second segment 204 may angle radially outward in a proximal direction, such that a distal end 206 of the second segment 204 has a smaller diameter than a proximal end 208 of the second segment 204. The second segment 204 may have a conical shape from the distal end 206 or inner end of the second segment 204 to the proximal end 208 or outer end of the second segment 204. The second segment 204 may have other shapes in examples (e.g., other polygon shapes).

[0076] In examples, the second segment 204 may extend at a single angle, or may have an invariant angle from the proximal end 208 to the distal end 206 as shown in FIG. 9 for example.

[0077] The first segment 202 extends at a greater angle relative to the longitudinal axis 71 than the second segment 204. The first segment 202, for example, may extend at a perpendicular angle relative to the longitudinal axis 71. The angle of the first segment 202 may form a radial offset from the proximal end 208 of the second segment 204 to the distal end 156 of the central portion 152. The angle of the first segment 202 may be a single angle in examples. The first segment 202 may extend from an inner end 210 of the first segment 202 (marked in FIG. 10) to an outer end 212 of the first segment 202 that joins with the distal end 156 of the central portion 152. The first segment 202 may form a plurality of wedges extending around the proximal end 208 of the second segment 204 in a similar manner as shown in FIG. 8 with the first segment 172 for example. The wedges may be positioned at the corners outside of the circumference of the proximal end 208 of the second segment 204. The wedges comprise a plurality of flanges extending radially outward. Each wedge may have a radius of between 2 millimeters and 4 millimeters (and may be 3 millimeters, producing a diameter offset of 6 millimeters), although lesser or greater amounts may be utilized as desired. The wedges jointhe second segment 204 of the distal end portion 200 to the distal end 156 of the central portion 152. The proximal end 208 of the second segment 204 is offset radially inward of the distal end 156 of the central portion 152 at the wedges.

[0078] The distal end portion 200 of the inflatable body 150 may include a third segment 220 in examples, which may extend at a lesser angle than the second segment 204 or the first segment 202. The third segment 220 may extend parallel with the longitudinal axis 71 in examples and may have a cylindrical shape. The third segment 220 may couple with the elongate catheter shaft 46 in examples.

[0079] Referring to FIGS. 8 and 11, in examples, each of the four side surfaces 160a-d may include a respective central longitudinally extending fold portion 230a-d that is configured to fold radially inward. The respective central longitudinally extending fold portions 230a-d may extend along the proximal end portion 170 and distal end portion 200 of the inflatable body 150 in examples as well. In examples, the central longitudinally extending fold portions 230a-d may comprise pre-formed creases in the side surfaces 160a-d or may otherwise comprise portions of the inflatable body 150 at which the inflatable body 150 is adapted to fold.

[0080] The longitudinally extending juncture lines 162a-d may be configured to form four raised ridges upon the side surfaces 160a-d folding radially inward. The longitudinally extending juncture lines 162a-d may be pre -formed creases of the inflatable body 150.

[0081] FIG. 12, for example, illustrates a cross sectional view of a deflated state of the inflatable body 150. The longitudinally extending fold portions 230a-d fold radially inward, with the longitudinally extending juncture lines 162a-d forming four raised ridges. The inflatable body 150 may fold radially inward to form four radially protruding arms 240a-d or fins (each comprising an overlap of two layers of material from two adjacent outer side surfaces 160a-d) extending outward perpendicular to the longitudinal axis 71. FIG. 13 illustrates a perspective view of a partial collapse and fold of the inflatable body 150 upon deflation.

[0082] The configuration of the inflatable body 150 may beneficially allow for an organized and predictable folding of the inflatable body 150 upon deflation. The central longitudinally extending fold portions 230a-d may each fold radially inward thus producing an organized fold pattern as represented in FIG. 12.

[0083] The configurations of the distal end portions and proximal end portions of the inflatable bodies 58, 150 may reduce the total amount of material forming the respective proximal end portions and distal end portions of the inflatable bodies 58, 150 as compared with an inflatable body 270 as shown in FIGS. 18 and 19. Such a feature may beneficially reduce a force of retrieval or retraction into a sheath in vivo. An organized folding pattern of the inflatable body 150 may also reduce the force of retrieval or retraction into a sheath in vivo.

[0084] FIG. 14 for example, illustrates an approach of the elongate catheter shaft 46 to an implantation site 250. The implant 10 is positioned upon the inflatable body 58 in a crimped or compressed state. The inflatable body 58 is inflated to expand the implant 10 at the implantation site 250 as represented in FIG. 15. The implant 10 comprises a prosthetic aortic heart valve and the implantation side comprises an aortic valve. In examples, other forms of deployment and implantation sites may be utilized.

[0085] The inflatable body 58 is utilized to expand the implant 10 at the implantation site 250. In an approach as shown in FIGS. 14 and 15, the elongate catheter shaft 46 is advanced through an aortic arch of the patient to approach the aortic valve, although other approaches may be utilized as desired (e.g., transapical or other approaches). The implant 10 is deployed at the implantation site 250 by inflating the inflatable body 58.

[0086] Following inflation, the inflatable body 58 is deflated to allow for removal from the vasculature of the patient. The deflated inflatable body 58 may be retracted through a sheath 260 having an interior lumen 262 (as marked in the cross-sectional view of FIG. 16). The interior lumen 262 is for the inflatable body 58 to be retracted into following deflation of the inflatable body 58. The retraction may occur within the vasculature of the patient (in vivo). In examples, the sheath 260 may comprise an introducer sheath for insertion and introduction into the patient’s vasculature (e.g., percutaneous entry into an artery or vein, among other forms of entry). A proximal portion of the sheath 260, for example, may remain outside of the patient’s body and a distal portion may remain within the patient’s vasculature. In examples, the sheath 260 may comprise a rigid sheath or an expandable sheath, among other forms of sheaths. The sheath opening 264 may comprise a diameter of between 24 French to 12 French, and may be in a range of between 14 French and 12 French in examples, although other ranges may be utilized as desired.

[0087] FIG. 17A illustrates the deflated inflatable body 58 retracted proximally towards a distal opening 264 of the sheath 260. FIG. 17B illustrates the inflatable body 58 passing through the distal opening 264 and into the sheath 260.

[0088] The configurations of the inflatable bodies 58, 150 may reduce the retraction or retrieval force into the sheath 260 as compared with an inflatable body 270 as represented in FIGS. 18 and 19. FIG. 20, for example, illustrates an exemplary chart of retrieval force in Newtons (N) of inflatable bodies through a sheath 260 as represented in FIG. 16. The diameter 266 of the sheath 260, for example, may be about 6 millimeters (mm) in examples, with the force of retrieval at the proximal end portion (the left column) and at the distal end portion (the right column) measured.

[0089] The bars in FIG. 20 marked with “Inflatable Body 1” correspond with the inflatable body 270 represented in FIGS. 18 and 19. The bars in FIG. 20 marked with “Inflatable body 2” correspond with the inflatable body 150. The bars in FIG. 20 marked with “Inflatable body 3” correspond with the inflatable body 58.

[0090] The inflatable body 150 is shown to have reduced retrieval force than the inflatable body 270. The inflatable body 58 is shown to have reduced retrieval force than the inflatable body 150. The reduced retrieval force is produced by the reduced total amount of material forming the respective proximal end portions and distal end portions of the inflatable bodies 58, 150 as compared with an inflatable body 270 as represented in FIGS. 18 and 19. The organized folding pattern of the inflatable body 150 reduces the force of retrieval or retraction into a sheath in vivo. For example, an inflatable body 270 as represented in FIGS. 18 and 19 may deflate into an undesirable flat configuration (e.g., a planar shape with protruding ends), which may increase the retrieval force (as a flat shape is attempted to be passed through a round distal opening 264). An organized fold may reduce the possibility of such shapes being formed upon deflation. The inflatable body may fold upon deflation into a narrow configuration more closely having a profile similar to the profile prior to inflation.

[0091] As discussed, various forms of implants may be utilized with the examples disclosed herein, including prosthetic heart valves, or other forms of implants, such as stents or filters, or diagnostic devices, among others. The implants may be expandable implants configured to move from a compressed or undeployed state to an expanded or deployed state. The implants may be compressible implants configured to be compressed inward to have areduced outer profile and to move the implant to the compressed or undeployed state. A crimping device may assist in moving the implant to the compressed or undeployed state.

[0092] The delivery apparatuses as disclosed herein may be utilized for aortic, mitral, tricuspid, and pulmonary replacement and repair as well. The delivery apparatuses may comprise delivery apparatuses for delivery of other forms of implants, such as stents or filters, or diagnostic devices, among others.

[0093] The delivery apparatuses and the systems disclosed herein may be used in transcatheter aortic valve implantation (TAVI) or replacement of other native heart valves (e.g., mitral, tricuspid, or pulmonary). The delivery apparatuses and the systems disclosed herein may be utilized for transarterial access, including transfemoral access, to a patient’s heart. The delivery apparatuses and systems may be utilized in transcatheter percutaneous procedures, including transarterial procedures, which may be transfemoral or transjugular. Transapical procedures, among others, may also be utilized. Other procedures may be utilized as desired.

[0094] Features of examples may be modified, substituted, excluded, or combined across examples as desired.

[0095] In addition, the methods herein are not limited to the methods specifically described, and may include methods of utilizing the systems and apparatuses disclosed herein. The steps of the methods may be modified, excluded, or added to, with systems, apparatuses, and methods disclosed herein.

[0096] The features of the examples disclosed herein may be implemented independently of other components disclosed herein. The various apparatuses of the system may be implemented independently.

[0097] For purposes of this description, certain aspects, advantages, and novel features of the implementations of this disclosure are described herein. The disclosed methods, apparatuses, and systems should not be construed as limiting in any way. Instead, the present disclosure is directed toward all novel and nonobvious features and aspects of the various disclosed implementations, along and in various combinations and sub-combinations with one another. The methods, apparatuses, 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. Features, elements, or combinations of one example can be combined into other implementations herein.

[0098] Example 1 : A delivery system for an expandable implant, the delivery system comprising: a delivery catheter configured to deliver the expandable implant to a location in a patient’s body and including: an elongate catheter shaft having a longitudinal axis; and an inflatable body coupled to the elongate catheter shaft and surrounding a chamber for receiving fluid for inflation of the inflatable body, the inflatable body including: a central portion configured to press an interior surface of the implant to expand the implant, the central portion having a proximal end and a distal end and a length between the proximal end and the distal end, a proximal end portion joined to the proximal end of the central portion, the proximal end portion including at least a first segment and a second segment that is positioned proximal of the first segment, the first segment and the second segment each being angled radially outward from the longitudinal axis, the first segment having a greater angle relative to the longitudinal axis than the second segment, and a distal end portion joined to the distal end of the central portion, the distal end portion including at least a first segment and a second segment that is positioned distal of the first segment of the distal end portion, the first segment of the distal end portion and the second segment of the distal end portion each being angled radially outward from the longitudinal axis, the first segment of the distal end portion having a greater angle relative to the longitudinal axis than the second segment of the distal end portion.

[0099] Example 2: The delivery system of any example herein, in particular example 1, wherein the central portion has a cylindrical shape.

[0100] Example 3: The delivery system of any example herein, in particular example 1 or example 2, wherein the central portion has a uniform diameter from the proximal end to the distal end.

[0101] Example 4: The delivery system of any example herein, in particular examples 1-3, wherein the central portion has a square cross-sectional profile transverse to the longitudinal axis.

[0102] Example 5: The delivery system of any example herein, in particular examples 1-4, wherein the central portion has a rectangular shape.

[0103] Example 6: The delivery system of any example herein, in particular example 5, wherein the central portion includes four longitudinally extending outer side surfaces joined at four longitudinally extending juncture lines, each of the outer side surfaces including a central longitudinally extending fold portion configured to fold radially inward.

[0104] Example 7: The delivery system of any example herein, in particular example 6, wherein the four longitudinally extending juncture lines are configured to form four raised ridges upon each of the outer side surfaces folding radially inward.

[0105] Example 8: The delivery system of any example herein, in particular examples 1-7, wherein the second segment of the proximal end portion has a conical shape, and the second segment of the distal end portion has a conical shape.

[0106] Example 9: The delivery system of any example herein, in particular examples 1-8, wherein the second segment of the proximal end portion extends at a single angle, and the second segment of the distal end portion extends at a single angle.

[0107] Example 10: The delivery system of any example herein, in particular examples 1-9, wherein the first segment of the proximal end portion extends at a single angle, and the first segment of the distal end portion extends at a single angle.

[0108] Example 11 : The delivery system of any example herein, in particular examples 1-10, wherein the first segment of the proximal end portion extends perpendicular to the longitudinal axis, and the first segment of the distal end portion extends perpendicular to the longitudinal axis.

[0109] Example 12: The delivery system of any example herein, in particular examples 1-11 , wherein the central portion has a cylindrical shape, and the first segment of the proximal end portion comprises a ring joining the second segment of the proximal end portion to the proximal end of the central portion, and the first segment of the distal end portion comprises a ring joining the second segment of the distal end portion to the distal end of the central portion.

[0110] Example 13: The delivery system of any example herein, in particular examples 1-12, wherein the central portion has a rectangular shape, and the first segment of the proximal end portion comprises a plurality of wedges joining the second segment of the proximal end portion to the proximal end of the central portion, and the first segment of the distal end portion comprises a plurality of wedges joining the second segment of the distal end portion to the distal end of the central portion.

[0111] Example 14: The delivery system of any example herein, in particular examples 1-13, further comprising a nose cone coupled to the elongate catheter shaft distal of the inflatable body.

[0112] Example 15: The delivery system of any example herein, in particular examples 1-14, further comprising an inflation lumen extending along the elongate catheter shaft and for passing fluid into the chamber for inflating the inflatable body.

[0113] Example 16: The delivery system of any example herein, in particular examples 1-15, further comprising a handle positioned at a proximal portion of the elongate catheter shaft.

[0114] Example 17: The delivery system of any example herein, in particular examples 1-16, further comprising a sheath having an interior lumen for the inflatable body to be retracted into following deflation of the inflatable body.

[0115] Example 18: The delivery system of any example herein, in particular example 17, wherein the sheath is an introducer sheath for introduction into the patient’s vasculature.

[0116] Example 19: The delivery system of any example herein, in particular examples 1- 18, further comprising the implant, wherein the implant comprises a prosthetic heart valve.

[0117] Example 20: The delivery system of any example herein, in particular example 19, wherein the prosthetic heart valve is a prosthetic aortic heart valve.

[0118] Example 21: A method comprising: expanding an implant at an implantation site within a patient’s body utilizing an inflatable body, the implant being positioned upon the inflatable body and the inflatable body being coupled to an elongate catheter shaft and surrounding a chamber for receiving fluid for inflation of the inflatable body, the inflatable body including: a central portion configured to press an interior surface of the implant to expand the implant, the central portion having a proximal end and a distal end and a length between the proximal end and the distal end, a proximal end portion joined to the proximal end of the central portion, the proximal end portion including at least a first segment and a second segment that is positioned proximal of the first segment, the first segment and the second segment each being angled radially outward from a longitudinal axis of the elongate catheter shaft, the first segment having a greater angle relative to the longitudinal axis than the second segment, and a distal end portion joined to the distal end of the central portion, the distal end portion including at least a first segment and a second segment that is positioned distal of the first segment of the distal end portion, the first segment of the distal end portion and the second segment of the distal end portion each being angled radially outward from the longitudinal axis, the first segment of the distal end portion having a greater angle relative to the longitudinal axis than the second segment of the distal end portion.

[0119] Example 22: The method of any example herein, in particular example 21, wherein the central portion has a cylindrical shape.

[0120] Example 23: The method of any example herein, in particular example 21 or example 22, wherein the central portion has a uniform diameter from the proximal end to the distal end.

[0121] Example 24: The method of any example herein, in particular examples 21-23, wherein the central portion has a square cross-sectional profile transverse to the longitudinal axis.

[0122] Example 25: The method of any example herein, in particular examples 21-24, wherein the central portion has a rectangular shape.

[0123] Example 26: The method of any example herein, in particular example 25, wherein the central portion includes four longitudinally extending outer side surfaces joined at four longitudinally extending juncture lines, each of the outer side surfaces including a central longitudinally extending fold portion configured to fold radially inward.

[0124] Example 27: The method of any example herein, in particular example 26, wherein the four longitudinally extending juncture lines are configured to form four raised ridges upon each of the outer side surfaces folding radially inward.

[0125] Example 28: The method of any example herein, in particular examples 21-27, wherein the second segment of the proximal end portion has a conical shape, and the second segment of the distal end portion has a conical shape.

[0126] Example 29: The method of any example herein, in particular examples 21-28, wherein the second segment of the proximal end portion extends at a single angle, and the second segment of the distal end portion extends at a single angle.

[0127] Example 30: The method of any example herein, in particular examples 21-29, wherein the first segment of the proximal end portion extends at a single angle, and the first segment of the distal end portion extends at a single angle.

[0128] Example 31: The method of any example herein, in particular examples 21-30, wherein the first segment of the proximal end portion extends perpendicular to the longitudinal axis, and the first segment of the distal end portion extends perpendicular to the longitudinal axis.

[0129] Example 32: The method of any example herein, in particular examples 21-31, wherein the central portion has a cylindrical shape, and the first segment of the proximal end portion comprises a ring joining the second segment of the proximal end portion to the proximal end of the central portion, and the first segment of the distal end portion comprises a ring joining the second segment of the distal end portion to the distal end of the central portion.

[0130] Example 33: The method of any example herein, in particular examples 21-32, wherein the central portion has a rectangular shape, and the first segment of the proximal end portion comprises a plurality of wedges joining the second segment of the proximal end portion to the proximal end of the central portion, and the first segment of the distal end portion comprises a plurality of wedges joining the second segment of the distal end portion to the distal end of the central portion.

[0131] Example 34: The method of any example herein, in particular examples 21-33, further comprising a nose cone coupled to the elongate catheter shaft distal of the inflatable body.

[0132] Example 35: The method of any example herein, in particular examples 21-34, further comprising an inflation lumen extending along the elongate catheter shaft and for passing fluid into the chamber for inflating the inflatable body.

[0133] Example 36: The method of any example herein, in particular examples 21-35, further comprising a handle positioned at a proximal portion of the elongate catheter shaft.

[0134] Example 37: The method of any example herein, in particular examples 21-36, further comprising a sheath having an interior lumen for the inflatable body to be retracted into following deflation of the inflatable body.

[0135] Example 38: The method of any example herein, in particular examples 21-37, wherein the implant comprises a prosthetic heart valve.

[0136] Example 39: The method of any example herein, in particular examples 21-38, wherein the implantation site is an aortic valve of the patient, and the method further comprises : advancing the elongate catheter shaft through an aortic arch of the patient to approach the aortic valve; and deploying the implant at the aortic valve utilizing the inflatable body.

[0137] Example 40: The method of any example herein, in particular example 39, further comprising: inflating the inflatable body to expand the implant at the aortic valve; deflating theinflatable body; and retracting the deflated inflatable body through a sheath within the patient’s vasculature.

[0138] Any of the features of any of the examples, including but not limited to any of the first through 40 examples referred to above, is applicable to all other aspects and examples identified herein, including but not limited to any examples of any of the first through 40 examples referred to above. Moreover, any of the features of an example of the various examples, including but not limited to any examples of any of the first through 40 examples referred to above, is independently combinable, partly or wholly with other examples described herein in any way, e.g., one, two, or three or more examples may be combinable in whole or in part. Further, any of the features of the various examples, including but not limited to any examples of any of the first through 40 examples referred to above, may be made optional to other examples. Any example of a method can be performed by a system or apparatus of another example, and any aspect or example of a system or apparatus can be configured to perform a method of another aspect or example, including but not limited to any examples of any of the first through 40 examples referred to above.

[0139] In closing, it is to be understood that although aspects of the present specification are highlighted by referring to specific examples, one skilled in the art will readily appreciate that these disclosed examples are only illustrative of the principles of the subject matter disclosed herein. Therefore, it should be understood that the disclosed subject matter is in no way limited to a particular methodology, protocol, and / or reagent, etc., described herein. As such, various modifications or changes to or alternative configurations of the disclosed subject matter can be made in accordance with the teachings herein without departing from the spirit of the present specification. Lastly, the terminology used herein is for the purpose of describing particular examples only, and is not intended to limit the scope of systems, apparatuses, and methods as disclosed herein, which is defined solely by the claims. Accordingly, the systems, apparatuses, and methods are not limited to that precisely as shown and described.

[0140] Certain examples of systems, apparatuses, and methods are described herein, including the best mode known to the inventors for carrying out the same. Of course, variations on these described examples will become apparent to those of ordinary skill in the art upon reading the foregoing description. The inventor expects skilled artisans to employ such variations as appropriate, and the inventors intend for the systems, apparatuses, and methods to be practiced otherwise than specifically described herein. Accordingly, the systems,apparatuses, 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 examples in all possible variations thereof is encompassed by the systems, apparatuses, and methods unless otherwise indicated herein or otherwise clearly contradicted by context.

[0141] Groupings of alternative examples, elements, or steps of the systems, apparatuses, 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 any such inclusion or deletion occurs, the specification is deemed to contain the group as modified thus fulfilling the written description of all Markush groups used in the appended claims.

[0142] Unless otherwise indicated, all numbers expressing a characteristic, item, quantity, parameter, property, term, and so forth used in the present specification and claims are to be understood as being modified in all instances by the term “about.” As used herein, the term “about” means that the characteristic, item, quantity, parameter, property, or term so qualified encompasses an approximation that may vary, yet is capable of performing the desired operation or process discussed herein.

[0143] The terms “a,” “an,” “the” and similar referents used in the context of describing the systems, apparatuses, and methods (especially in the context of the following claims) are to be construed to cover both the singular and the plural, unless otherwise indicated herein or clearly contradicted by context. All methods described herein can be performed in any suitable order unless otherwise indicated herein or otherwise 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, apparatuses, and methods and does not pose a limitation on the scope of the systems, apparatuses, and methods otherwise claimed. No language in the present specification should be construed as indicating any non-claimed element essential to the practice of the systems, apparatuses, and methods.

[0144] All patents, patent publications, and other publications referenced and identified in the present specification are individually and expressly incorporated herein by reference in their entirety for the purpose of describing and disclosing, for example, the compositions and methodologies described in such publications that might be used in connection with thesystems, apparatuses, and methods. These publications are provided solely for their disclosure prior to the filing date of the present application. Nothing in this regard should be construed as an admission that the inventors are not entitled to antedate such disclosure by virtue of prior invention or for any other reason. All statements as to the date or representation as to the contents of these documents is based on the information available to the applicants and does not constitute any admission as to the correctness of the dates or contents of these documents.

Claims

WHAT IS CLAIMED IS:

1. A delivery system for an expandable implant, the delivery system comprising: a delivery catheter configured to deliver the expandable implant to a location in a patient’s body and including: an elongate catheter shaft having a longitudinal axis; and an inflatable body coupled to the elongate catheter shaft and surrounding a chamber for receiving fluid for inflation of the inflatable body, the inflatable body including: a central portion configured to press an interior surface of the implant to expand the implant, the central portion having a proximal end and a distal end and a length between the proximal end and the distal end, a proximal end portion joined to the proximal end of the central portion, the proximal end portion including at least a first segment and a second segment that is positioned proximal of the first segment, the first segment and the second segment each being angled radially outward from the longitudinal axis, the first segment having a greater angle relative to the longitudinal axis than the second segment, and a distal end portion joined to the distal end of the central portion, the distal end portion including at least a first segment and a second segment that is positioned distal of the first segment of the distal end portion, the first segment of the distal end portion and the second segment of the distal end portion each being angled radially outward from the longitudinal axis, the first segment of the distal end portion having a greater angle relative to the longitudinal axis than the second segment of the distal end portion.

2. The delivery system of claim 1, wherein the central portion has a cylindrical shape.

3. The delivery system of claim 1 or claim 2, wherein the central portion has a uniform diameter from the proximal end to the distal end.

4. The delivery system of any of claims 1-3, wherein the central portion has a square cross- sectional profile transverse to the longitudinal axis.

5. The delivery system of any of claims 1-4, wherein the central portion has a rectangular shape.

6. The delivery system of claim 5, wherein the central portion includes four longitudinally extending outer side surfaces joined at four longitudinally extending juncture lines, each of the outer side surfaces including a central longitudinally extending fold portion configured to fold radially inward.

7. The delivery system of claim 6, wherein the four longitudinally extending juncture lines are configured to form four raised ridges upon each of the outer side surfaces folding radially inward.

8. The delivery system of any of claims 1-7, wherein the second segment of the proximal end portion has a conical shape, and the second segment of the distal end portion has a conical shape.

9. The delivery system of any of claims 1-8, wherein the second segment of the proximal end portion extends at a single angle, and the second segment of the distal end portion extends at a single angle.

10. The delivery system of any of claims 1-9, wherein the first segment of the proximal end portion extends at a single angle, and the first segment of the distal end portion extends at a single angle.

11. The delivery system of any of claims 1-10, wherein the first segment of the proximal end portion extends perpendicular to the longitudinal axis, and the first segment of the distal end portion extends perpendicular to the longitudinal axis.

12. The delivery system of any of claims 1-11, wherein the central portion has a cylindrical shape, and the first segment of the proximal end portion comprises a ring joining the second segment of the proximal end portion to the proximal end of the central portion, and the first segment of the distal end portion comprises a ring joining the second segment of the distal end portion to the distal end of the central portion.

13. The delivery system of any of claims 1-12, wherein the central portion has a rectangular shape, and the first segment of the proximal end portion comprises a plurality of wedges joining the second segment of the proximal end portion to the proximal end of the central portion, and the first segment of the distal end portion comprises a plurality of wedges joining the second segment of the distal end portion to the distal end of the central portion.

14. The delivery system of any of claims 1-13, further comprising a nose cone coupled to the elongate catheter shaft distal of the inflatable body.

15. The delivery system of any of claims 1-14, further comprising an inflation lumen extending along the elongate catheter shaft and for passing fluid into the chamber for inflating the inflatable body.

16. The delivery system of any of claims 1-15, further comprising a handle positioned at a proximal portion of the elongate catheter shaft.

17. The delivery system of any of claims 1-16, further comprising a sheath having an interior lumen for the inflatable body to be retracted into following deflation of the inflatable body.

18. The delivery system of claim 17, wherein the sheath is an introducer sheath for introduction into the patient’s vasculature.

19. The delivery system of any of claims 1-18, further comprising the implant, wherein the implant comprises a prosthetic heart valve.

20. The delivery system of claim 19, wherein the prosthetic heart valve is a prosthetic aortic heart valve.

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