Delivery device having a balloon for delivering a prosthesis and a pull wire for manipulating the balloon

Abstract

A delivery device includes a handle, a sheath extending distally from the handle, a balloon extending distally from the sheath, and a pull wire having a proximal end attached to the handle and a distal end attached to the balloon. The sheath defines a central lumen therethrough and has a longitudinally extending lumen formed within a wall of the sheath. The balloon has a tubular body having a middle region having a plurality of ribs and a plurality of grooves defined therein. The balloon includes a recessed segment defined on the tubular body, the recessed segment being disposed radially inwardly relative to the tubular body. The pull wire is tensioned to bend the balloon. The pull wire is slidably disposed within the longitudinally extending lumen of the sheath and along the inner surface of the tubular body of the balloon, wherein a portion of the pull wire spans the outer surface of the recessed segment.

Description

Technical Field

[0001] The present invention relates to a system for percutaneous transcatheter delivery and implantation of a prosthesis such as a stent, stent graft or artificial valve. More particularly, the present invention relates to a delivery device comprising a balloon for delivering the prosthesis and a pull wire for manipulating the balloon. Background Art

[0002] Among the medical catheters commonly used to access blood vessels and other locations within the body and perform various functions at these locations are medical catheters or delivery catheters adapted to deliver and deploy medical devices, such as prosthetic heart valves, stent grafts, and stents, to selected target sites within the body. Once the catheter is navigated to and positioned at the target treatment / deployment site, such medical devices are typically releasably carried in a radially compressed delivery state within the distal region of the delivery catheter. In many cases, such as those involving cardiovascular procedures, the path to the treatment / deployment site can be tortuous, and conflicting design considerations may arise, requiring compromises between size, flexibility, material selection, operational control, and the like.

[0003] Typically, the advancement of a delivery catheter within a patient is monitored by fluoroscopy, allowing the clinician to manipulate the catheter to steer and guide its distal end through the patient's vasculature to the target treatment / deployment site. This tracking requires that the distal end of the delivery catheter be safely navigated to the target treatment / deployment site by the clinician manipulating the proximal end. Such manipulation can involve pushing forces, retracting forces, and torsional forces, or a combination of all three. Therefore, the distal end of the delivery catheter needs to be able to withstand all of these forces.

[0004] Delivery catheters ideally have a low profile / small outer diameter to facilitate navigation through tortuous vasculature; however, small outer diameter catheters present various design difficulties caused by competing considerations, resulting in design trade-offs. For example, such delivery catheters must be flexible enough to navigate the tortuous vasculature or anatomical structures of a patient. However, typical configurations of delivery catheters must seek to balance the required flexibility with axial strength / rigidity (properties that allow the delivery catheter to be pushed and pulled) and torsional strength / rigidity (properties that allow the delivery catheter to rotate about its longitudinal axis). Balancing these properties is particularly important in the distal portion of the delivery catheter, where the prosthesis is maintained in its compressed delivery state.

[0005] There remains a general need in the art for improved devices and methods for navigating through or within a patient's anatomy. Summary of the Invention

[0006] Embodiments of the present invention relate to a delivery device comprising a handle, a sheath extending distally from the handle, a balloon extending distally from the sheath, and a pull wire having a proximal end attached to the handle and a distal end attached to the balloon. The sheath defines a central lumen therethrough and has a longitudinally extending lumen formed within a wall of the sheath. The balloon has a tubular body having a middle region having a plurality of ribs and a plurality of grooves defined therein. The balloon includes a recessed segment defined on the tubular body, the recessed segment being disposed radially inwardly relative to the tubular body. The pull wire is tensioned to bend the balloon. The pull wire is slidably disposed within the longitudinally extending lumen of the sheath and disposed along an inner surface of the tubular body of the balloon, wherein a portion of the pull wire spans an outer surface of the recessed segment.

[0007] Embodiments of the present invention also relate to a delivery system for transcatheter delivery of a prosthesis, comprising a delivery device and a prosthesis. The delivery device comprises a handle, a sheath extending distally from the handle, a sac extending distally from the sheath, and a pull wire having a proximal end attached to the handle and a distal end attached to the sac. The sheath defines a central lumen passing therethrough and has a longitudinally extending lumen formed within the wall of the sheath. The sac has a tubular body having a middle region with a plurality of ribs and a plurality of grooves defined therein. The sac includes a recessed segment defined on the tubular body, the recessed segment being disposed radially inwardly relative to the tubular body. The pull wire is tensioned to bend the sac. The pull wire is slidably disposed within the longitudinally extending lumen of the sheath and disposed along the inner surface of the tubular body of the sac, wherein a portion of the pull wire spans the outer surface of the recessed segment. The prosthesis is configured to be disposed within the sac of the sheath in a radially compressed delivery state and to unfold to an expanded state after being released from the sac of the sheath.

[0008] Embodiments of the present invention also relate to methods for delivering and deploying a prosthesis at a treatment site. A delivery system is advanced through the vascular system to the treatment site. The delivery system includes a delivery device and a prosthesis. The delivery device includes a handle, a sheath extending distally from the handle, a balloon extending distally from the sheath, and a pull wire having a proximal end attached to the handle and a distal end attached to the balloon. The sheath defines a central lumen extending therethrough and has a longitudinally extending cavity formed within its wall. The balloon has a tubular body having a central region with a plurality of ribs and a plurality of grooves defined therein. The balloon includes a recessed segment defined in the tubular body, the recessed segment being positioned radially inward relative to the tubular body. The prosthesis is positioned within the balloon of the sheath in a compressed delivery state. The pull wire is slidably positioned within the longitudinally extending lumen of the sheath and along the inner surface of the tubular body of the balloon, with a portion of the pull wire crossing the outer surface of the recessed segment. The pull wire is tensioned to flex the balloon. The balloon is retracted to deploy the prosthesis to an expanded, deployed state at the treatment site. BRIEF DESCRIPTION OF THE DRAWINGS

[0009] The foregoing and other features and advantages of the present invention will become apparent from the following description of the embodiments herein as illustrated in the accompanying drawings. The accompanying drawings, which are incorporated herein and form a part of this specification, further serve to explain the principles of the invention and enable one skilled in the art to make and use the invention. The drawings are not drawn to scale.

[0010] Figure 1 is a side view of a delivery system according to an embodiment of the present invention, wherein the delivery system includes a balloon, and the balloon is shown in a non-flexed configuration.

[0011] Figure 1A It is along Figure 1 A cross-sectional view taken along line AA.

[0012] Figure 1B It is along Figure 1 A cross-sectional view taken along line BB.

[0013] Figure 2 yes Figure 1 Side view of a delivery system in which the balloon is shown in a bent configuration.

[0014] Figure 3A yes Figure 1 1. Side view of an exemplary heart valve prosthesis of a delivery system of FIG. 1, wherein the heart valve prosthesis is shown in a compressed or delivery configuration.

[0015] Figure 3B yes Figure 3A Side view of a heart valve prosthesis shown in an expanded or deployed configuration.

[0016] Figure 4 yes Figure 1 A perspective view of a balloon and pull wire of a delivery system of FIG. 1 , wherein the balloon and pull wire are removed from the rest of the delivery system for illustrative purposes.

[0017] Figure 5 yes Figure 4 An enlarged view of a portion of the bladder showing the anchoring slot of the bladder with the pull wire attached thereto.

[0018] Figure 6 yes Figure 4 An enlarged view of a portion of the bladder showing the recessed segment of the bladder with the pull wire extending thereover.

[0019] Figure 7 yes Figure 1 1 is a side view of a balloon of a delivery system of FIG. 1 , wherein the balloon is removed from the rest of the delivery system for illustrative purposes and the circumferential expansion feature of the balloon is shown in a non-expanded state.

[0020] Figure 8 yes Figure 1 1 is a side view of a balloon of a delivery system of FIG. 1 , wherein the balloon is removed from the rest of the delivery system for illustrative purposes and the circumferential expansion feature of the balloon is shown in an expanded state.

[0021] Figure 9 yes Figure 1 An enlarged perspective view of a portion of a balloon of a delivery system of FIG. 1 , wherein the balloon has been removed from the rest of the delivery system for illustrative purposes.

[0022] Figure 10 yes Figure 9 An enlarged view of a portion of FIG. 1 showing the anchoring grooves of the balloon.

[0023] Figure 11 is a flattened view of an anchoring groove of a bladder according to an embodiment of the present invention.

[0024] Figure 12 is a flattened view of an anchoring groove of a bladder according to another embodiment of the present invention.

[0025] Figure 13 is a perspective view of an attachment between a distal end of a pull wire and an anchoring channel of a balloon, wherein the attachment comprises welding, according to an embodiment of the present invention.

[0026] Figure 14 is a perspective view of an attachment between a distal end of a pull wire and an anchoring channel of a balloon according to another embodiment of the present invention, wherein the attachment comprises a loop.

[0027] Figure 15 is a perspective view of an attachment between a distal end of a pull wire and an anchoring slot of a balloon, wherein the attachment includes mating shapes, according to another embodiment of the present invention.

[0028] Figure 16 is a perspective view of an attachment between a distal end of a pull wire and an anchoring channel of a balloon according to another embodiment of the present invention, wherein the attachment comprises a metal strap.

[0029] Figure 17 yes Figure 1 An enlarged perspective view of a portion of a balloon of a delivery system of FIG. 1 , wherein the balloon is removed from the rest of the delivery system for illustrative purposes and showing a recessed segment of the balloon.

[0030] Figure 18 is a cross-sectional view of the bladder taken through a recessed segment of the bladder.

[0031] Figure 19 yes Figure 18 A magnified view of a portion of the .

[0032] Figure 20 is a flattened view of a concave segment of a bladder according to an embodiment of the present invention.

[0033] Figure 21 is a flattened view of a recessed segment of a bladder according to another embodiment of the present invention.

[0034] Figure 22 is a perspective view of a draw wire extending over a recessed section of the bladder.

[0035] Figure 23 yes Figure 22 A magnified view of a portion of the .

[0036] Figure 24 is a side view of a bladder according to another embodiment of the present invention, wherein the bladder includes an alternative cutting pattern.

[0037] Figure 25 yes Figure 24 A perspective view of a portion of a sac.

[0038] Figure 26 is a side view of a bladder according to another embodiment of the present invention, wherein the bladder includes an alternative cutting pattern.

[0039] Figure 27 yes Figure 26 A perspective view of a portion of a sac.

[0040] Figure 28 is a side view of a bladder according to another embodiment of the present invention, wherein the bladder includes an alternative cutting pattern.

[0041] Figure 29 yes Figure 28 A perspective view of a portion of a sac.

[0042] Figure 30 is a side view of a bladder according to another embodiment of the present invention, wherein the bladder includes an alternative cutting pattern.

[0043] Figure 31 yes Figure 30 A perspective view of a portion of a sac.

[0044] Figure 32 yes Figure 30 A flattened view of a portion of a sac.

[0045] Figure 33 is a side view of a bladder according to another embodiment of the present invention, wherein the bladder includes an alternative cutting pattern.

[0046] Figure 34 yes Figure 33 A perspective view of a portion of a sac.

[0047] Figure 35 yes Figure 33 A flattened view of a portion of a sac. DETAILED DESCRIPTION

[0048] Specific embodiments of the present invention will now be described with reference to the accompanying drawings, in which like reference numerals indicate identical or functionally similar elements. The terms "distal" and "proximal" when used in the following description to refer to a sheath, delivery device, or catheter-based delivery system are with respect to a position or direction relative to a treating clinician. Thus, "distal" and "distally" refer to a position away from or in a direction away from a treating clinician, and the terms "proximal" and "proximally" refer to a position close to or in a direction toward a treating clinician. The terms "distal" and "proximal" when used in the following description to refer to a device to be implanted in a blood vessel, such as a heart valve prosthesis, are used with reference to the direction of blood flow from the heart. Thus, "distal" and "distally" refer to a position in a downstream direction relative to the direction of blood flow, and the terms "proximal" and "proximally" refer to a position in an upstream direction relative to the direction of blood flow.

[0049] The following detailed description is merely exemplary in nature and is not intended to limit the invention or the application and uses of the invention. In addition, no one is expected to be bound by any explicit or implicit theory presented in the foregoing technical field, background, summary or the following detailed description.

[0050] Embodiments of the present invention relate to a delivery device 100 for delivering a prosthesis 101. The prosthesis 101 is held or positioned within a balloon 112 of the delivery device 100 in a radially compressed delivery state. The delivery device 100 is configured to hold the prosthesis 101 in a radially compressed state for delivery to a treatment site, such as a native aortic valve or a native mitral valve. The delivery device 100 is also configured to release the prosthesis 101 at the treatment site, and the prosthesis 101 is configured to deploy to an expanded state after being released from the balloon 112. It should be understood that the prosthesis 101 described herein is shown by way of example and not limitation, and that any other prosthesis may be suitably delivered by the delivery device 100 according to embodiments of the present invention.

[0051] The delivery device 100 includes a tubular assembly or sheath 102 and a handle 150 coupled to and extending proximally from a proximal end 104 of the sheath 102. The sheath 102 has a distal end 106 opposite the handle 150, and a proximal end 118 of the balloon 112 is attached to the distal end 106 of the sheath 102 such that the balloon 112 extends distally from the sheath 102. Figure 1 is a side view of the delivery device 100 with the balloon 112 in a straight or non-bent configuration and Figure 2 is a side view of the delivery device 100 with the balloon 112 in a bent or curved configuration. More specifically, the pull wire 140 ( Figure 1 and 2The pull wire 140 is selectively tensioned by the user to bend the bladder 112 into a desired position. Figure 2 The size of the curvature of the balloon 112 in the bent or curved configuration depends on the target anatomy for which the delivery device 100 is to be used and / or the size or profile of the delivery device 100. In embodiments where the delivery device 100 is to be used in a TAVI or transcatheter aortic valve implantation procedure, the radius of curvature of the balloon 112 in the bent or curved configuration ranges from twenty (20) millimeters to sixty (60) millimeters.

[0052] The sheath 102 can be formed from one or more polymeric materials, non-exhaustive examples of which include laminated, blended, or coextruded polyethylene, polyethylene block amide copolymers (PEBA), polyamides, and / or combinations thereof. Optionally, the sheath 102 or portions thereof can be formed as a composite material having a reinforcement layer incorporated into a polymeric body to increase strength and / or flexibility and / or torquability. Suitable reinforcement layers include braids, mesh layers, embedded axial filaments, embedded spiral or circumferential filaments, hypotubes, and the like. For example, in one embodiment, at least the proximal portion of the sheath 102 can be formed from a reinforced polymeric tube.

[0053] Figure 1A It is along Figure 1 The line AA intercepts Figure 1 A cross-sectional view of the sheath 102 is shown. Figure 1A As best shown, the sheath 102 defines a central lumen 108 extending therethrough, i.e., from its proximal end 104 to its distal end 106, and a longitudinally extending lumen 110 is formed with the wall of the sheath 102 and extends from its proximal end 104 to its distal end 106. In an embodiment, the longitudinally extending lumen 110 is preformed in the wall of the sheath 102 and can be formed, for example, by extrusion of a multi-lumen profile. The central lumen 108 is sized or configured to accommodate the inner shaft 146, while the longitudinally extending lumen 110 accommodates the pull wire 140. In an embodiment of the present invention, the longitudinally extending lumen 110 can have a rectangular cross-section to accommodate the pull wire 140, which can have a flat or flattened longitudinal profile. In another embodiment (not shown), the longitudinally extending lumen 110 and the pull wire 140 disposed therethrough can have a different configuration or shape, including an oval or circular shape. The pull wire 140 is slidably disposed within the longitudinally extending lumen 110 so that a user can selectively tighten the pull wire 140 to bend the bladder 112. As used herein, "slidably" means in a longitudinal direction along or generally parallel to the central longitudinal axis L of the delivery device 100. AWhile the pull wire 140 is primarily housed or disposed within the longitudinally extending lumen 110 of the sheath 102 , the proximal end 142 extends proximally beyond the proximal end 104 of the sheath 102 and can be accessed via the handle 150 to be pulled or pushed, which results in controlled bending movement of the balloon 112 .

[0054] Also like Figure 1A As shown, the sheath 102 is slidably positioned on the inner shaft 146. The inner shaft 146 is a tubular component that defines a central lumen 148 passing therethrough. In an embodiment, the central lumen 148 can be configured to slidably receive a guide wire (not shown) passing therethrough. The proximal end (not shown) of the inner shaft 146 is attached or fixed within the handle 150. In an embodiment, the inner shaft 146 is longitudinally reinforced with one or more axial wires 149A, 149B. More specifically, the inner shaft 146 is formed of a polymer material such as polyethylene, polyethylene block amide copolymer (PEBA), polyamide, or nylon, which encapsulates a braid 147 and axial wires 149A, 149B positioned at circumferentially relative positions. The braid 147 can be a conventional metal braid (e.g., a stainless steel braid) and can be omitted in other embodiments. The axial wires 149A, 149B can be made of a structurally strong material, such as stainless steel, and have a flattened or rectangular shape in some embodiments as shown. While other shapes are acceptable, the flattened configuration provides greater mass and therefore improved maneuverability.

[0055] The handle 150 includes a first actuator mechanism 152 for retracting the balloon 112 and a second actuator mechanism 154 for tensioning the pull wire 140. The handle 150 can have any shape or size suitable for convenient operation by the user. The first actuator mechanism 152 is coupled to the sheath 102 and is generally configured to provide for selective proximal retraction and distal advancement of the sheath 102, and in particular the balloon 112 attached thereto, relative to the prosthesis 101 held therein in a radially compressed delivery state, to cover and uncover the prosthesis 101. The first actuator mechanism 152 can employ any configuration capable of providing the desired sheath actuation function, such as those described in U.S. Patent No. 8,579,963 to Tabor, assigned to the same assignee as the present disclosure and incorporated herein by reference in its entirety. The second actuator mechanism 154 is coupled to the proximal end 142 of the pull wire 140 and is generally configured to provide for selective proximal retraction and distal advancement of the proximal end 142 of the pull wire 140. In other words, the second actuator mechanism is coupled to the proximal end 142 of the pull wire 140 and is configured to selectively push or pull the pull wire 140. The second actuator mechanism 154 can take any configuration capable of providing the desired pull wire actuation functionality, such as those described in U.S. patent application Ser. No. 15 / 065,938 to Griffin, filed Mar. 10, 2016, assigned to the same assignee as the present disclosure, and which is incorporated herein by reference in its entirety.

[0056] Figure 1B It is along Figure 1 1 and 12. FIG. 1 is a cross-sectional view taken along line BB of FIG. 1 and depicts the prosthesis 101 loaded within the capsule 112 of the delivery device 100. FIG. Figure 3A is a side view of the prosthesis 101 removed from the delivery device 100 and shown in a compressed or delivery configuration, and Figure 3B is a side view of the prosthesis 101 removed from the delivery device 100 and shown in an expanded or delivery configuration. Generally speaking, the prosthesis 101 includes a stent-like frame 360 ​​for supporting a valve structure 362, which typically includes two or more leaflets 364. The stent-like frame 360 ​​is a generally tubular support structure having an interior region or cavity within which the valve structure 362 having the leaflets 364 is to be secured. As is known to those of ordinary skill in the art, the valve structure 362 can be constructed of tissue and / or synthetic materials. The stent-like frame 360 ​​is constructed of a shape memory material so as to be configured to self-expand or return to a shape memory when released from the capsule 112 of the delivery device 100. Figure 3BIn embodiments of the present invention, any of the heart valve prostheses disclosed in U.S. Patent Application Publication No. 2014 / 0222142 to Kovalsky et al. and U.S. Patent No. 8,226,710 to Nguyen et al. (each of which is incorporated herein by reference in its entirety) can be delivered and deployed by a delivery device as described herein. Additionally, prosthesis 101 can be a prosthesis available from Medtronic Core Valve, LLC under the trade name In addition, any other heart valve prosthesis can be delivered and deployed using the delivery devices described herein. Figure 3A and 3B In an embodiment, the prosthesis 101 is configured to replace or repair an aortic valve. Alternatively, other shapes are also contemplated that are adapted to the specific anatomy of the valve to be repaired (e.g., an artificial heart valve according to the present disclosure can be shaped and / or sized to replace a native mitral valve, pulmonary valve, or tricuspid valve).

[0057] Now go to Figure 4 , the bladder 112 according to an embodiment of the present invention will now be described in more detail. Figure 4 1 is a perspective view of a balloon 112 and a pull wire 140, which have been removed from the rest of the delivery system for illustrative purposes. The balloon 112 has a tubular body 114 and includes a proximal end 118 and a distal end 120, and defines a lumen 116 therethrough that is in fluid communication with the central lumen 108 of the sheath 102. A mid-region 122 of the tubular body 114 includes a plurality of grooves 126 separated or demarcated by a plurality of ribs 124, such that each rib 124 is generally separated from an adjacent rib 124 by a groove 126. The plurality of ribs 124 and the plurality of grooves 126 are substantially oriented about the central longitudinal axis L of the delivery device 100. A A plurality of ribs 124 and a plurality of grooves 126 are formed by laser cutting the tubular body 114 and are configured to impart non-kinking flexibility to the sac 112 that allows the sac 112 to bend when the pull wires 140 are selectively tensioned, thereby reducing the tension required to bend the sac 112 and the prosthesis 101 retained therein.

[0058] Figure 5 The attachment points between the pull wire 140 and the bladder 114 are shown, as shown in FIG. Figure 5 As best shown in the enlarged view of FIG, the balloon 112 includes an anchoring groove 136 formed through the wall of the tubular body 114 of the balloon 112. The distal end 144 of the pull wire 140 is attached or secured to the balloon 112 at the anchoring groove 136. The anchoring groove 136 is disposed distally from the plurality of ribs 124 and the plurality of grooves 126 of the intermediate region 122 of the tubular body 114 of the balloon 112. Figures 9 to 12The anchor groove 136 is described in more detail.

[0059] As described above, the pull wire 140 is slidably disposed within the longitudinally extending lumen 110 of the sheath 102 and is also disposed along the inner surface 130 of the tubular body 114 of the balloon 112. The balloon 112 includes a recessed segment 128 defined on the tubular body 114 that is configured to ensure that the pull wire 140 remains flush with or taut against the inner surface 130 of the tubular body 114 of the balloon 112. The recessed segment 128 is disposed proximate the plurality of ribs 124 and the plurality of grooves 126 of the intermediate region 122 of the tubular body 114 of the balloon 112. The recessed segment 128 is an integral portion of the tubular body 114 that is disposed radially inward relative to the remainder of the tubular body 114. Figure 6 yes Figure 4 , and depicts an enlarged view of a portion of the recessed segment 128 with the pull wire 140 extending thereover. A portion of the pull wire 140 spans over the outer surface 134 of the recessed segment 128. More specifically, the pull wire 140 extends beside or adjacent to the inner surface 130 of the tubular body 114 near the recessed segment 128 and extends beside or adjacent to the inner surface 130 of the tubular body 114 away from the recessed segment 128. However, the pull wire 140 extends above the outer surface 134 of the recessed segment 128. Thus, the recessed segment 128 holds or secures the pull wire 140 so that it is flush with or taut against the inner surface 130 of the tubular body 114 of the bladder 112. Figures 17 to 23 The recessed segment 128 is described in more detail.

[0060] Now about Figure 7 and 8 Describing the structure of the capsule 112 in more detail, Figure 7 and 8 A side view of the capsule 112 is depicted removed from the rest of the delivery device 100. The proximal end 118 of the capsule 112 is configured to be mounted to the distal end 106 of the sheath 102 and, in some configurations, includes a plurality of circumferentially spaced apart fingers 170, each terminating in a proximal end 172. In some configurations, the proximal end 172 of each of the fingers 170 may have an enlarged width as shown. Regardless, the spaced apart fingers 170 are easily inserted into (or alternatively over) the distal end 106 of the sheath 102 to facilitate attachment thereto (e.g., adhesive bonding, heat fusion, etc.).

[0061] The distal end 120 of the balloon 112 includes a circumferential expansion feature 138 that is configured to transition between a normal or non-expanded state and an expanded state when subjected to an expansion force, and to self-transform back to the normal state when the expansion force is removed. In this regard, the circumferential expansion feature 138 is particularly configured to reduce the force required to retract the partially expanded prosthesis 101 while increasing the axial strength and resistance to buckling of the balloon 112. Figure 7 In FIG, the circumferential expansion feature 138 of the bladder is shown in a non-expanded state, while in Figure 8 , the circumferential expansion feature 138 of the balloon is shown in an expanded state. The diameter of the circumferential expansion feature 138 is larger in the expanded state than in the normal or non-expanded state. At least the circumferential expansion feature 138 of the balloon 112 is formed of a shape memory material such as Nitinol and facilitates the expansion of the balloon 112 in the expanded state. Figure 7 The non-open state and Figure 8 In this regard, various shape memory materials may be used for the balloon 112, such as steel, polymers, and the like. In some embodiments, the balloon 112 is a nitinol material, and in particular a superelastic nitinol material. The circumferential expansion feature 138 is useful during retraction of the prosthesis 101 during implantation and is further described in greater detail in U.S. Patent No. 8,562,673 to Yeung et al., assigned to the same assignee as the present disclosure, and incorporated herein by reference in its entirety.

[0062] The middle region 122 of the tubular body 114 is disposed longitudinally between the proximal end 118 of the bladder 112 and the distal end 120 of the bladder 112. In summary, the middle region 122 incorporates features that impart circumferential or radial stiffness but allow or promote lateral articulation, these features being designed to give the bladder 112 sufficient axial and radial strength to prevent buckling or kinking. For example, in some embodiments, the bladder 112 includes a partially coiled or spiral cut pattern along the middle region 122 that establishes a plurality of generally circumferentially extending ribs 124. Longitudinally adjacent ones of the ribs 124 are separated by grooves 126. The grooves 126 are circumferentially discontinuous, extending less than 180°. As such, the grooves 126 are helically aligned but separated from one another. Thus, the cut pattern establishes one or more longitudinal ridges 127. Utilizing Figure 7 and 8 The structure of the ridge 127 is formed in two circumferential directions relative to each other (it should be understood that in Figure 7 and 8 Only one of the ridges 127 is visible).

[0063] The discontinuous grooves 126 and ridges 127 generally connect or hold adjacent ones of the ribs 124 relative to each other, but allow for lateral articulation such that the capsule 112 can be bent via the pull wires 140. Other configurations that facilitate the desired lateral articulation are also contemplated. While flexible (due to material strength, thickness, and circumferential width) for the desired bending or articulation, the combination of the ridges 127 and ribs 124 provides the intermediate region 122 with enhanced hoop strength properties to constrain the prosthesis 101 in the folded arrangement, as well as longitudinal stability for distally propelling the capsule 112 over the partially deployed (and radially expanded) prosthesis 101. Utilizing these and other embodiments, the capsule 112 can be configured to readily identify the location of the ridges 127 to the user.

[0064] In addition to the plurality of ribs 124 and the plurality of grooves 126, the intermediate region 122 of the bladder 112 may include one or more additional reflow zones 123A, 123B. The first reflow zone 123A is positioned between the distal end 120 and the cut pattern of ribs 124 / grooves 126, and the second reflow zone 123B is positioned between the proximal end 118 and the cut pattern of ribs 124 / grooves 126. In an embodiment, the bladder 112 may be encapsulated within an inner polymeric layer or liner and an outer polymeric layer or jacket (not shown). The inner and outer polymeric layers reflow during manufacturing, and the reflow zones 123A, 123B allow the reflow material (the material of the inner and outer polymeric layers in a semi-liquid form) to pass therethrough. As a result, the inner and outer polymeric layers fuse or bond together during the reflow process to encapsulate the bladder 112. In an embodiment, each of the reflow zones 123A, 123B includes a plurality of circumferentially spaced holes in the form of a ring. In an embodiment, each of the recirculation zones 123A, 123B includes at least two rings of circumferentially spaced holes. In an embodiment, the recirculation zone 123A includes exactly two rings of circumferentially spaced holes, while the recirculation zone 123B includes exactly three rings of circumferentially spaced holes. Furthermore, in an embodiment, the diameter of the holes in the recirculation zone 123B is greater than the diameter of the holes in the recirculation zone 123A. Other configurations of the recirculation zones 123A, 123B are also acceptable, and in some embodiments, one or more of the recirculation zones 123A, 123B may be omitted.

[0065] Now go to Figures 9 to 11 , the anchoring groove 136 of the balloon 112 will be described in more detail. Figure 9 is an enlarged perspective view of a portion of the capsule 112, which has been removed from the rest of the delivery system for illustrative purposes. Figure 10 yes Figure 9 , to clearly illustrate the anchor groove 136. Figure 11is a flattened view of the anchoring groove 136 of the balloon 112; the anchoring groove 136 is an opening or hole formed through the wall of the tubular body 114 of the balloon 112. In other words, the anchoring groove 136 extends from the outer surface 132 of the tubular body 114 to the inner surface 130 of the tubular body. Figure 5 As shown and described, the anchoring slot 136 serves as an attachment point between the pull wire 140 and the bladder 114, wherein the distal end 144 of the pull wire 140 is attached or secured to the bladder 112 at the anchoring slot 136. In this embodiment, the anchoring slot 136 is oblong or rectangular with its longer length parallel to the longitudinal axis L of the bladder 112. A .

[0066] The anchoring groove 136 is disposed on the middle region 122 of the tubular body 114 of the balloon 112. As previously described, the anchoring groove 136 is disposed distally from the plurality of ribs 124 and the plurality of grooves 126 on the middle region 122 of the tubular body 114. Furthermore, the anchoring groove 136 is disposed within the recirculation zone 123A. The anchoring groove 136 extends from the distal-most groove 126A to the proximal end 139 of the circumferentially flared feature 138. As shown in FIG. Figure 11 As best shown in the flattened view of FIG, the anchor groove 136 extends over two rings of circumferentially spaced holes of the recirculation zone 123A. In another embodiment of the present invention, the anchor groove can be relatively shorter in length so as not to extend over two rings of circumferentially spaced holes of the recirculation zone 123A. More specifically, Figure 12 Another embodiment of the present invention is depicted in which the anchoring grooves 1236 of the balloon 1212 are relatively shorter in length compared to the anchoring grooves 136. The anchoring grooves 1236 extend from the distal-most grooves 1226A to the proximal-most ring of circumferentially spaced apertures of the regurgitant zone 123A.

[0067] The distal end 144 of the pull wire 140 may be attached to the anchoring slot 136 using one of several attachment methods, and one of ordinary skill in the art will appreciate that the attachment method depends on the material of the pull wire 140. For example, in Figure 13 In the depicted embodiment, the pull wire 140 is formed of nitinol or stainless steel, and a weld 1380 is used to attach the distal end 144 of the pull wire 140 to the anchoring slot 136. Alternatively, a bond or adhesive may be used to attach the distal end 144 of the pull wire 140 to the anchoring slot 136. Figure 14 In another embodiment depicted, the pull wire 140 is formed of KEVLAR or another relatively stiff polymer material. The distal end 144 is wrapped around the outer surface or periphery of the balloon 112 to form a loop 144A. The distal end 144 can be fed back into the anchoring groove 136 and the polymer material of the distal end 144 is reflowed to attach the distal end 144 to the loop 144A. Alternatively, a knot (not shown) can be formed to attach the polymer material of the distal end 144 to the loop 144A. Figure 15In another embodiment depicted, the pull wire 1540 is formed of nitinol or stainless steel and includes a dovetail 1544A at its distal end 1544. The dovetail 1544A is flared, and the anchoring slot 1536 of the balloon 1512 has a matching or corresponding shape such that the dovetail 1544A at the distal end 1544 of the pull wire 1540 has an interference fit within the anchoring slot 1536. In other words, the matching shapes of the anchoring slot 1536 and the dovetail 1544A at the distal end 1544 of the pull wire 1540 provide a method of attachment.

[0068] exist Figure 16 In the depicted embodiment, the pull wire 140 (from Figure 16 The distal end 144 of the pull wire 140 is attached to the metal band 1682 by welding. Figure 16 In the depicted embodiment, the metal band 1682 is a loop of uniform or constant width.

[0069] Now go to Figures 17 to 20 , the recessed segment 128 will be described in more detail. Figure 17 is an enlarged perspective view of a portion of the capsule 112, which has been removed from the rest of the delivery system for illustrative purposes. Figure 18 is a cross-sectional view of the capsule 112 taken through the recessed segment 128, and Figure 19 yes Figure 18 , to clearly illustrate the recessed segment 128. Figure 20 1 is a flattened view of a recessed segment 128 of the bladder 112; the recessed segment 128 is formed or defined on the tubular body 114 of the bladder 112. The recessed segment 128 is an integral portion of the tubular body 114 that is disposed radially inwardly relative to the remainder of the tubular body 114. More specifically, during manufacture of the bladder 112, two opposing cuts or slots (not shown) are formed on either side of the recessed segment 128. After the two opposing cuts are formed, a force is applied to recess the recessed segment 128 such that the recessed segment 128 is recessed and bends or flexes radially inwardly. The recessed segment 128 is then heat set. The recessed segment 128 has a Figure 19 The recess depth D is shown. After the recessed segment 128 is formed, two opposing radial notches 129A, 129B extend between the tubular body 114 and the recessed segment 128. More specifically, the proximal radial notch 129A extends between the tubular body 114 and the proximal edge of the recessed segment 128, and the distal radial notch 129B extends between the tubular body 114 and the distal edge of the recessed segment 128. The recess depth D of the recessed segment 128 is greater than the thickness of the pull wire 140 and is configured to allow the pull wire 140 ( Figures 17 to 20In this embodiment, the recessed section 128 is rectangular or oblong, with its longer length perpendicular to the longitudinal axis L of the bladder 112. A .

[0070] The recessed segment 128 is disposed on the middle region 122 of the tubular body 114 of the bladder 112. As previously described, the recessed segment 128 is disposed proximate to the plurality of ribs 124 and the plurality of grooves 126 on the middle region 122 of the tubular body 114. The recessed segment 128 extends from the proximal most groove 126B and is disposed away from the recirculation zone 123B of the middle region 122. Figures 17 to 20 In one embodiment, the recessed segments 128 are formed to be in fluid communication with the nearest side groove 126B. In another embodiment of the present invention, the recessed segments are spaced apart and formed adjacent to the nearest side groove. More specifically, Figure 21 Another embodiment of the present invention is depicted in which the recessed section 2128 of the bladder 2112 is spaced apart from the proximal-most groove 2126B of the bladder 2112 .

[0071] As previously described, the recessed segment 128 is configured to ensure that the pull wire 140 remains flush or taut with the inner surface 130 of the tubular body 114 of the balloon 112 . Figure 22 is a perspective view of a draw wire extending over a recessed section of the bladder, and Figure 23 yes Figure 22 128. As described above, the pull wire 140 is slidably disposed within the longitudinally extending lumen 110 of the sheath 102 and is also disposed along the inner surface 130 of the tubular body 114 of the balloon 112. A portion of the pull wire 140 spans the outer surface 134 of the recessed segment 128. More specifically, the pull wire 140 passes through the radial notches 129A, 129B such that as the pull wire 140 extends from the sheath 102 to the anchoring groove 136 of the balloon 112, the pull wire 140 spans the recessed segment 128, which is disposed distally of the recessed segment 128. The pull wire 140 extends beside or adjacent the inner surface 130 of the tubular body 114 proximate the recessed segment 128, extends over the outer surface 134 of the recessed segment 128, and extends beside or adjacent the inner surface 130 of the tubular body 114 distally of the recessed segment 128. Thus, the recessed segment 128 holds or secures the pull wire 140 so that it is flush with or taut against the inner surface 130 of the tubular body 114 of the balloon 112 .

[0072] Tension is applied to the pull wire 140 to bend the balloon 112 as desired and thereby manipulate the delivery device 100 within the vasculature as it is advanced through the vasculature to the treatment site. For example, the delivery device 100 is manipulated to advance the compressed prosthesis 101 in a retrograde manner toward the target site of implantation, through an incision of the femoral artery, and into the patient's descending aorta. The delivery device 100 is then advanced over the aortic arch, through the ascending aorta, and approximately through the middle of the defective aortic valve (to be replaced) under fluoroscopic guidance. As the delivery device 100 is advanced over the aortic arch, the pull wire 140 is tensioned to bend the balloon 112 and manipulate the delivery device over the aortic arch. Once positioning of the delivery device 100 is complete, the balloon 112 is retracted to deploy the prosthesis 101 to its expanded or deployed state at the treatment site.

[0073] As described above, in embodiments of the present invention, the middle region 122 of the tubular body 114 incorporates features that impart circumferential or radial stiffness but allow or promote lateral articulation, these features being designed to give the balloon 112 sufficient axial and radial strength to prevent buckling or kinking when bent or bent via tensioning of the pull wire 140 while the balloon 112 is being maneuvered through the vasculature in situ. The balloon 112 includes a partially coiled or spiral cut pattern along the middle region 122 that establishes a plurality of ribs 124, a plurality of grooves 126, and two circumferentially opposed longitudinal ridges 127. The plurality of ribs 124 of the balloon 112 are shown in the above embodiments as having a uniform pitch. Reference Figures 24 to 35 , additional embodiments of the intermediate region of the bladder are contemplated herein. Figures 24 to 35 Embodiments reduce the bending stiffness of the bladder while maintaining column stiffness to reduce the wire load required to steer the bladder, or to achieve a greater amount of steering for the same wire load.

[0074] More specifically, Figures 24 to 25 The bladder 2412 is shown. It will be understood that the bladder 2412 is substantially similar to the bladder 112 except for the cut pattern of the plurality of ribs 2424 and the plurality of grooves 2426 along its middle region 2422. The bladder 2412 has a proximal end 2418, a distal end 2420, recirculation zones 2423A, 2423B, an anchoring groove ( Figures 24 to 25 Not shown) and recessed segments ( Figures 24 to 25 2412) are identical to the proximal end 118, distal end 120, recirculation zones 123A, 123B, anchoring groove 136, and recessed segment 128 of the balloon 2412 and are therefore not described in detail herein.

[0075] The middle region 2422 of the capsule 2412 includes a plurality of ribs 2424 and a plurality of grooves 2426 formed by a partially coiled or spiral cut pattern. Longitudinally adjacent ribs in the ribs 2424 are separated by grooves 2426. The grooves 2426 are circumferentially discontinuous, extending less than 180°. Thus, the grooves 2426 are spirally aligned but separated from each other. Thus, the cut pattern establishes one or more longitudinal ridges 2427. Figure 24 and 25 The structure of the two ridges 2427 is formed relative to each other circumferentially (it should be understood that Figure 24 and 25 Only one of the ridges 2427 is visible in FIG. 24 ). The discontinuous grooves 2426 and ridges 2427 generally connect or hold adjacent ones of the ribs 2424 relative to each other, but allow for lateral articulation such that the bladder 2412 can be moved via a draw wire ( Figures 24 to 25 (not shown) bending.

[0076] The cutting pattern of the plurality of ribs 2424 and the plurality of grooves 2426 can be considered to include three overall regions or areas, including a proximal region 2490, a distal region 2494, and a middle region 2492 extending between the proximal region 2490 and the distal region 2494. The proximal, middle, and distal regions 2490, 2492, 2494 are respectively Figure 24 In an embodiment, the proximal region 2490 extends between 5% and 15% of the total length of the cutting pattern, the middle region 2492 extends between 10% and 25% of the total length of the cutting pattern, and the distal region extends between 60% and 85% of the total length of the cutting pattern.

[0077] exist Figures 24 to 25 In one embodiment, the width of the ridge 2427 along the distal region 2494 tapers or decreases relative to the width of the ridge 2427 along the proximal region 2492. More specifically, the width of the ridge 2427 along the distal region 2494 is W1 and the width of the ridge 2427 along the proximal region 2492 is W2, where W2 is approximately twice the size of W1. The width of the ridge 2427 along the mid-region 2492 tapers from the size of W2 to the size of W1. The width W2 of the ridge 2427 along the proximal region 2492 is relatively greater than the width of the ridge 127 of the bladder 112.

[0078] In addition, Figures 24 to 25In the embodiment of the present invention, the middle region 2492 has increased spacing between the plurality of ribs 2424. More specifically, the width of each slot 2426 along the middle region 2492 is increased relative to the width of each slot 2426 along the proximal and distal regions 2490, 2494, respectively. To compensate for the increased width of the slots 2426 along the middle region 2492, the width of each rib 2424 along the middle region 2492 is reduced relative to the width of each rib 2424 along the proximal and distal regions 2490, 2494, respectively.

[0079] Figures 26 to 27 Another embodiment of a bladder 2612 is depicted. It will be understood that the bladder 2612 is substantially similar to the bladder 112 except for the cut pattern of the plurality of ribs 2624 and the plurality of grooves 2626 along its middle region 2622. The bladder 2612 has a proximal end 2618, a distal end 2620, recirculation zones 3023A, 3023B, an anchoring groove ( Figures 26 to 27 Not shown) and recessed segments ( Figures 26 to 27 26) are identical to the proximal end 118, distal end 120, recirculation regions 123A, 123B, anchoring groove 136, and recessed segment 128 of balloon 2612 and are therefore not described in detail herein.

[0080] The middle region 2622 of the bladder 2612 includes a plurality of ribs 2624 and a plurality of grooves 2626 formed by a partially coiled or spiral cut pattern. Longitudinally adjacent ribs in the ribs 2624 are separated by grooves 2626. The grooves 2626 are circumferentially discontinuous, extending less than 180°. Thus, the grooves 2626 are spirally aligned but separated from each other. Thus, the cut pattern creates one or more longitudinal ridges 2627. Figure 26 and 27 The structure of the two ridges 2627 is formed relative to each other circumferentially (it should be understood that Figure 26 and 27 Only one of the ridges 2627 is visible in FIG. 26 ). The discontinuous grooves 2626 and ridges 2627 generally connect or hold adjacent ones of the ribs 2624 relative to each other, but allow for lateral articulation such that the bladder 2612 can be moved via a draw wire ( Figures 26 to 27 (not shown) bending.

[0081] The cutting pattern of the plurality of ribs 2624 and the plurality of grooves 2626 can be considered to include three overall regions or areas, including a proximal region 2690, a distal region 2694, and a middle region 2692 extending between the proximal region 2690 and the distal region 2694. The proximal, middle, and distal regions 2690, 2692, 2694 are respectively Figure 26In an embodiment, the proximal region 2690 extends between 5% and 15% of the total length of the cutting pattern, the middle region 2692 extends between 10% and 25% of the total length of the cutting pattern, and the distal region extends between 60% and 85% of the total length of the cutting pattern.

[0082] exist Figures 26 to 27 In the embodiment of the present invention, the middle region 2692 has increased spacing between the plurality of ribs 2624. More specifically, the width of each slot 2626 along the middle region 2692 is increased relative to the width of each slot 2626 along the proximal and distal regions 2690, 2694, respectively. To compensate for the increased width of the slots 2626 along the middle region 2692, the width of each rib 2624 along the middle region 2692 is reduced relative to the width of each rib 2624 along the proximal and distal regions 2690, 2694, respectively.

[0083] Figures 28 to 29 Another embodiment of a bladder 2812 is depicted. It will be understood that the bladder 2812 is substantially similar to the bladder 112 except for the cut pattern of the plurality of ribs 2824 and the plurality of grooves 2826 along its middle region 2822. The bladder 2812 has a proximal end 2818, a distal end 2820, recirculation zones 2823A, 2823B, an anchoring groove ( Figures 28 to 29 Not shown) and recessed segments ( Figures 28 to 29 28) are identical to the proximal end 118, distal end 120, recirculation regions 123A, 123B, anchoring groove 136, and recessed segment 128 of balloon 2812 and are therefore not described in detail herein.

[0084] The middle region 2822 of the bladder 2812 includes a plurality of ribs 2824 and a plurality of grooves 2826 formed by a partially coiled or spiral cut pattern. Longitudinally adjacent ribs in the ribs 2824 are separated by grooves 2826. The grooves 2826 are circumferentially discontinuous, extending less than 180°. Thus, the grooves 2826 are spirally aligned but separated from each other. Thus, the cut pattern establishes one or more longitudinal ridges 2827. Figure 28 and 29 The structure of the two ridges 2827 is formed relative to each other circumferentially (it should be understood that Figure 28 and 29 Only one of the ridges 2827 is visible in FIG. 28 ). The discontinuous grooves 2826 and ridges 2827 generally connect or hold adjacent ones of the ribs 2824 relative to each other, but allow for lateral articulation such that the bladder 2812 can be moved via a draw wire ( Figures 28 to 29 (not shown) bending.

[0085] The cutting pattern of the plurality of ribs 2824 and the plurality of grooves 2826 can be considered to include three overall regions or areas, including a proximal region 2890, a distal region 2894, and a middle region 2892 extending between the proximal region 2890 and the distal region 2894. The proximal, middle, and distal regions 2890, 2892, 2894 are respectively Figure 28 In an embodiment, the proximal region 2890 extends between 5% and 15% of the total length of the cutting pattern, the middle region 2892 extends between 10% and 25% of the total length of the cutting pattern, and the distal region extends between 60% and 85% of the total length of the cutting pattern.

[0086] exist Figures 28 to 29 In an embodiment, the width of the ridge 2827 along the distal region 2894 is tapered or reduced relative to the width of the ridge 2827 along the proximal region 2892. More specifically, the width of the ridge 2827 along the distal region 2894 is W1 and the width of the ridge 2827 along the proximal region 2892 is W2, where W2 is approximately twice the size of W1. The width of the ridge 2827 along the mid-region 2892 tapers from the size of W2 to the size of W1. The width W2 of the ridge 2827 along the proximal region 2892 is approximately the same as the width of the ridge 127 of the bladder 112. In contrast, Figures 28 to 29 The width W2 of the ridge 2827 along the proximal region 2892 is relatively greater than the width of the ridge 127 of the bladder 112.

[0087] In addition, Figures 28 to 29 In the embodiment of the present invention, the middle region 2892 has increased spacing between the plurality of ribs 2824. More specifically, the width of each slot 2826 along the middle region 2892 is increased relative to the width of each slot 2826 along the proximal and distal regions 2890, 2894, respectively. To compensate for the increased width of the slots 2826 along the middle region 2892, the width of each rib 2824 along the middle region 2892 is reduced relative to the width of each rib 2824 along the proximal and distal regions 2890, 2894, respectively.

[0088] Figures 30 to 32 Another embodiment of a bladder 3012 is depicted. It will be understood that the bladder 3012 is substantially similar to the bladder 112 except for the cut pattern of the plurality of ribs 3024 and the plurality of grooves 3026 along its middle region 3022. The bladder 3012 has a proximal end 3018, a distal end 3020, recirculation zones 3023A, 3023B, an anchoring groove ( Figures 30 to 32 Not shown) and recessed segments ( Figures 30 to 32 3012) are identical to the proximal end 118, distal end 120, recirculation zones 123A, 123B, anchoring groove 136, and recessed segment 128 of the balloon 3012 and are therefore not described in detail herein.

[0089] The middle region 3022 of the bladder 3012 includes a plurality of ribs 3024 and a plurality of grooves 3026 formed by a partially coiled or spiral cut pattern. Longitudinally adjacent ribs in the ribs 3024 are separated by grooves 3026. The grooves 3026 are circumferentially discontinuous, extending less than 180°. Thus, the grooves 3026 are spirally aligned but separated from each other. Thus, the cut pattern creates one or more longitudinal ridges 3027. Figures 30 to 32 The structure of the two ridges 3027 is formed relative to each other circumferentially (it should be understood that Figures 30 to 32 Only one of the ridges 3027 is visible in FIG. 30). The discontinuous grooves 3026 and ridges 3027 generally connect or hold adjacent ones of the ribs 3024 relative to each other, but allow for lateral articulation such that the bladder 3012 can be moved laterally via a draw wire ( Figures 30 to 32 (not shown) bending.

[0090] The cut pattern of the plurality of ribs 3024 and the plurality of grooves 3026 can be considered to include three overall regions or areas, including a proximal region 3090, a distal region 3094, and a middle region 3092 extending between the proximal region 3090 and the distal region 3094. The proximal, middle, and distal regions 3090, 3092, 3094 are respectively Figure 30 In an embodiment, the proximal region 3090 extends between 5% and 15% of the total length of the cutting pattern, the middle region 3092 extends between 10% and 25% of the total length of the cutting pattern, and the distal region extends between 60% and 85% of the total length of the cutting pattern.

[0091] exist Figures 30 to 32 In one embodiment, the width of each groove 3026 along the central region 3092 varies along the length of the groove. The width of each groove 3026 along the central region 3092 increases substantially along its entire length, but tapers toward the ridge 3027 at its opposite ends 3095A, 3095B. Due to the increasing width of each groove 3026 along the central region 3092, the central region 3092 has increased spacing between the plurality of ribs 3024. The width of each groove 3026 along the central region 3092 increases relative to the width of each groove 3026 along the proximal and distal regions 3090, 3094, respectively. To compensate for the increased width of the groove 3026 along the central region 3092, the width of each rib 3024 along the central region 3092 decreases relative to the width of each rib 3024 along the proximal and distal regions 3090, 3094, respectively.

[0092] exist Figures 33 to 35 In another embodiment of the invention depicted, the central region may alternatively have a reduced number of ribs, rather than having thinner ribs to compensate for the increased slot width. More specifically, Figures 33 to 35 The bladder 3312 is shown. It will be understood that the bladder 3312 is substantially similar to the bladder 112 except for the cut pattern of the plurality of ribs 3324 and the plurality of grooves 3326 along its middle region 3322. The bladder 3312 has a proximal end 3318, a distal end 3320, recirculation zones 3323A, 3323B, an anchoring groove ( Figures 33 to 35 Not shown) and recessed segments ( Figures 33 to 35 33) are identical to the proximal end 118, distal end 120, recirculation zones 123A, 123B, anchoring groove 136, and recessed segment 128 of the balloon 3312 and are therefore not described in detail herein.

[0093] The middle region 3322 of the bladder 3312 includes a plurality of ribs 3324 and a plurality of grooves 3326 formed by a partially coiled or spiral cut pattern. Longitudinally adjacent ribs in the ribs 3324 are separated by grooves 3326. The grooves 3326 are circumferentially discontinuous, extending less than 180°. Thus, the grooves 3326 are spirally aligned but separated from each other. Thus, the cut pattern establishes one or more longitudinal ridges 3327. Figures 33 to 35 The structure of the two ridges 3327 is formed relative to each other circumferentially (it should be understood that Figures 33 to 35 Only one of the ridges 3327 is visible in FIG. 33). The discontinuous grooves 3326 and ridges 3327 generally connect or hold adjacent ones of the ribs 3324 relative to each other, but allow for lateral articulation such that the bladder 3312 can be moved via a draw wire ( Figures 33 to 35 (not shown) bending.

[0094] The cut pattern of the plurality of ribs 3324 and the plurality of grooves 3326 can be considered to include three overall regions or areas, including a proximal region 3390, a distal region 3394, and a middle region 3392 extending between the proximal region 3390 and the distal region 3394. The proximal, middle, and distal regions 3390, 3392, 3394 are respectively Figure 33 In an embodiment, the proximal region 3390 extends between 5% and 15% of the total length of the cutting pattern, the middle region 3392 extends between 10% and 25% of the total length of the cutting pattern, and the distal region extends between 60% and 85% of the total length of the cutting pattern.

[0095] exist Figures 33 to 35394, 396, 398, 399, 407, 414, 429, 438, 449, 477, 483, 498, 509, 514, 487, 499, 520, 538, 483, 499, 409, 414, 429, 438, 499, 409, 438, 49 ... Figures 30 to 32 The illustrated thinner ribs compensate for the increased slot width. The width of the ribs 3324 along the middle region 3392 is the same as the width of the ribs 3324 along the proximal and distal regions 3390, 3394, respectively.

[0096] Although only some embodiments according to the present invention are described herein, it should be understood that the embodiments are presented only by way of illustration and example and in a non-restrictive manner. Various changes may be made in form and detail without departing from the spirit and scope of the present invention. Further, each embodiment discussed herein and each feature of each reference cited herein may be used in combination with the features of any other embodiment. All patents and public documents discussed herein are incorporated herein by reference in their entirety.

Claims

1. A delivery device comprising: handle; a sheath extending distally from the handle, the sheath defining a central lumen therethrough and having a longitudinally extending lumen formed within a wall of the sheath; a balloon extending distally from the sheath, the balloon having a tubular body with a middle region having a plurality of ribs and a plurality of grooves defined therein, wherein the balloon includes a recessed segment defined on the tubular body, the recessed segment being disposed radially inward relative to the tubular body; as well as a pull wire having a proximal end attached to the handle and a distal end attached to the balloon, wherein the pull wire is tensioned to bend the balloon, and wherein the pull wire is slidably disposed within the longitudinally extending lumen of the sheath and along an inner surface of the tubular body of the balloon, wherein a portion of the pull wire spans an outer surface of the recessed segment, wherein the balloon of the sheath is configured to retain the prosthesis therein in a radially compressed state, and wherein the balloon is retractable to deploy the prosthesis to an expanded, deployed state at the treatment site, wherein the recessed segment is positioned proximate the plurality of ribs and the plurality of grooves of the middle region of the tubular body of the bladder.

2. The delivery device of claim 1, wherein the balloon further comprises an anchoring slot formed through a wall of the tubular body of the balloon, the distal end of the pull wire being attached to the balloon of the sheath at the anchoring slot.

3. The delivery device of claim 2, wherein the anchoring groove is disposed distally from the plurality of ribs and the plurality of grooves in the intermediate region of the tubular body of the balloon.

4. The delivery device of claim 1, wherein the plurality of ribs and the plurality of grooves extend substantially in a circumferential direction about a longitudinal axis of the balloon.

5. The delivery device of claim 1, wherein each rib of the plurality of ribs is separated from an adjacent rib of the plurality of ribs by one of the plurality of grooves.

6. The delivery device of claim 1, further comprising: An inner shaft is slidably disposed within the central lumen of the sheath.

7. The delivery device of claim 1, wherein a proximal end of the balloon is attached to a distal end of the sheath.

8. The delivery device of claim 1 , wherein the balloon comprises a circumferential expansion feature configured to transition between a normal state and an expanded state, the circumferential expansion feature having a larger diameter in the expanded state than in the normal state, wherein the balloon comprises a shape memory component configured to naturally assume the normal state.

9. A delivery system for transcatheter delivery of a prosthesis, comprising: A delivery device, comprising: handle; a sheath extending distally from the handle, the sheath defining a central lumen therethrough and having a longitudinally extending lumen formed within a wall of the sheath; a balloon extending distally from the sheath, the balloon having a tubular body with a middle region having a plurality of ribs and a plurality of grooves defined therein, wherein the balloon includes a recessed segment defined on the tubular body, the recessed segment being disposed radially inward relative to the tubular body; as well as a pull wire having a proximal end attached to the handle and a distal end attached to the balloon, wherein the pull wire is tensioned to bend the balloon, and wherein the pull wire is slidably disposed within the longitudinally extending lumen of the sheath and along an inner surface of the tubular body of the balloon, wherein a portion of the pull wire spans an outer surface of the recessed segment; as well as a prosthesis configured to be positioned within the balloon of the sheath in a radially compressed delivery state and configured to deploy to an expanded state after release from the balloon of the sheath, wherein the balloon of the sheath is configured to retain the prosthesis therein in a radially compressed state, and wherein the balloon is retractable to deploy the prosthesis to an expanded, deployed state at the treatment site, wherein the recessed segment is positioned proximate the plurality of ribs and the plurality of grooves of the middle region of the tubular body of the bladder.

10. The delivery system of claim 9, wherein the balloon further comprises an anchoring slot formed through a wall of the tubular body of the balloon, the distal end of the pull wire being attached to the balloon of the sheath at the anchoring slot.

11. The delivery system of claim 10, wherein the anchoring groove is disposed distally from the plurality of ribs and the plurality of grooves in the intermediate region of the tubular body of the balloon.

12. The delivery system of claim 9, wherein the plurality of ribs and the plurality of grooves extend substantially in a circumferential direction about a longitudinal axis of the balloon.

13. The delivery system of claim 9, wherein each rib of the plurality of ribs is separated from an adjacent rib of the plurality of ribs by one of the plurality of grooves.

14. The delivery system of claim 9, further comprising: An inner shaft is slidingly disposed within the central lumen of the sheath, wherein the prosthesis is disposed over a distal portion of the inner shaft.

15. The delivery system of claim 9, wherein a proximal end of the balloon is attached to a distal end of the sheath.

16. The delivery system of claim 9, wherein the prosthesis is a prosthetic heart valve.

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