Delivery device having a capsule with an integral flexible region for delivering a prosthesis

Abstract

A delivery device includes a handle, a sheath distally extending from the handle, and a capsule distally extending from the sheath. The capsule has a tubular body with an intermediate portion having a plurality of ribs and a plurality of slots defined therein. The intermediate portion of the capsule includes a middle region configured to overlap, overlay, cover or otherwise be disposed over a most flexible portion of a prosthesis disposed within the capsule. The middle region has higher flexibility and increased bendability relative to the remainder of the intermediate portion of the capsule.

Description

DELIVERY DEVICE HAVING A CAPSULE WITH AN INTEGRAL FLEXIBLEREGION FOR DELIVERING A PROSTHESISFIELD OF THE INVENTION

[0001] The present invention relates to systems for percutaneous transcatheter delivery and implantation of a prosthesis, such as a stent, a stent-graft or a prosthetic valve. More particularly, the present invention relates to a delivery device including a capsule for delivery of the prosthesis. BACKGROUND OF THE INVENTION

[0002] Among medical catheters commonly used to access vascular and other locations within a body and to perform various functions at those locations are medical catheters, or delivery catheters, adapted to deliver and deploy medical devices such as prosthetic heart valves, stentgrafts, and stents to selected targeted sites in the body. Such medical devices typically are releasably carried within a distal region of the delivery catheter in a radially compressed delivery state as the catheter is navigated to and positioned at a target treatment / deployment site. In many cases, such as those involving cardiovascular vessels, the route to the treatment / deployment site may be tortuous and may present conflicting design considerations requiring compromises between dimensions, flexibilities, material selection, operational controls and the like.

[0003] Typically advancement of a delivery catheter within a patient is monitored fluoroscopically to enable a 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 a distal end of the delivery catheter to be able to navigate safely to the target treatment / deployment site through manipulation of a proximal end by the clinician. Such manipulation may encompass pushing, retraction and torque forces or a combination of all three. It is therefore required for the distal end of the delivery catheter to be able to withstand all these force.

[0004] A delivery catheter desirably will have a low profile / small outer diameter to facilitate navigation through tortuous vasculature; however, small outer diameter catheters present various design difficulties resulting from competing considerations, resulting in design trade-offs. For instance, such delivery catheters must be flexible enough to navigate the tortuous vasculature or anatomy of a patient. However, typical constructions of delivery catheters must attempt to balance a requisite flexibility, with axial strength / stiffness (the property that permits the delivery catheter to be pushed and pulled), and torsional strength / stiffness (the property that permits the deliverycatheter to be rotated about its longitudinal axis). It is especially important to balance these properties in a distal portion of the delivery catheter within which a prosthesis is held in its compressed, delivery state.

[0005] A need in the art still generally exists for improved apparatus and methods for navigating through or within a patient’s anatomy.BRIEF SUMMARY OF THE INVENTION

[0006] In an aspect of a first embodiment, the disclosure provides a delivery device including a handle, a sheath distally extending from the handle, and a capsule distally extending from the sheath. The sheath defines a central lumen there-through. The capsule has a tubular body with an intermediate portion having a plurality of ribs and a plurality of slots defined therein, with longitudinally adjacent ribs of the plurality of ribs being separated by a slot of the plurality of slots. The plurality of ribs and the plurality of slots substantially extend in a circumferential direction around a longitudinal axis of the capsule. The intermediate portion of the tubular body includes a proximal region, a distal region, and a middle region extending between the proximal region and the distal region. Each slot of the plurality of slots defined within each of the proximal and distal regions is circumferentially discontinuous and extends less than 180 degrees around the tubular body. At least one slot of the plurality of slots defined within the middle region is a circumferentially continuous slot that extends more than 360 degrees around the tubular body, such that the circumferentially continuous slot has a spiral configuration with a plurality of windings.

[0007] In an aspect of the first embodiment, and in combination with any other aspects herein, the disclosure provides a pair of circumferentially opposing continuous longitudinal spines are formed on the tubular body along the distal region and along at least a portion of the proximal region.

[0008] In an aspect of the first embodiment, and in combination with any other aspects herein, the disclosure provides the proximal region extends between 40-50% of a total length of the intermediate portion, the middle region extends between 5-15% of the total length of the intermediate portion, and the distal region extends between 40-50% of the total length of the intermediate portion.

[0009] In an aspect of the first embodiment, and in combination with any other aspects herein, the disclosure provides the circumferentially continuous slot is singular and the middle region alsoincludes a plurality of circumferentially discontinuous slots which each extend between 350 and 359 degrees around the tubular body.

[0010] In an aspect of the first embodiment, and in combination with any other aspects herein, the disclosure provides each circumferentially discontinuous slot of the plurality of circumferentially discontinuous slots of the middle region is disposed between a pair of longitudinally adjacent windings of the singular circumferentially continuous slot.

[0011] In an aspect of the first embodiment, and in combination with any other aspects herein, the disclosure provides the circumferentially continuous slot includes a first circumferentially continuous slot and a second circumferentially continuous slot. Each of the first circumferentially continuous slot and the second circumferentially continuous slot extends more than 360 degrees around the tubular body and has a spiral configuration with a plurality of windings.

[0012] In an aspect of the first embodiment, and in combination with any other aspects herein, the disclosure provide each winding of the first circumferentially continuous slot is disposed between a pair of longitudinally adjacent windings of the second circumferentially continuous slot.

[0013] In an aspect of the first embodiment, and in combination with any other aspects herein, the disclosure provides the capsule of the sheath is configured to retain a prosthesis in a radially compressed state therein.

[0014] In an aspect of the first embodiment, and in combination with any other aspects herein, the disclosure provides a pull wire having a proximal end attached to the handle and a distal end attached to the capsule. The pull wire is tensioned to bend the capsule.

[0015] In an aspect of the first embodiment, and in combination with any other aspects herein, the disclosure provides a proximal end of the capsule is attached to a distal end of the sheath.

[0016] In an aspect of the first embodiment, and in combination with any other aspects herein, the disclosure provides the capsule includes a circumferentially flaring feature configured to transition between a normal state and a flared state, a diameter of the circumferentially flaring feature being greater in the flared state than in the normal state. The capsule includes a shape memory component constructed to naturally assume the normal state.

[0017] In an aspect of a second embodiment, the disclosure provides a delivery system for transcatheter delivery of a prosthesis including a delivery device and a prosthesis. The delivery device includes a handle, a sheath distally extending from the handle, and a capsule distally extending from the sheath. The sheath defines a central lumen there-through. The capsule has atubular body with an intermediate portion having a plurality of ribs and a plurality of slots defined therein, with longitudinally adjacent ribs of the plurality of ribs being separated by a slot of the plurality of slots. The plurality of ribs and the plurality of slots substantially extend in a circumferential direction around a longitudinal axis of the capsule. The intermediate portion of the tubular body includes a proximal region, a distal region, and a middle region extending between the proximal region and the distal region. Each slot of the plurality of slots defined within each of the proximal and distal regions is circumferentially discontinuous and extends less than 180 degrees around the tubular body. At least one slot of the plurality of slots defined within the middle region is a circumferentially continuous slot that extends more than 360 degrees around the tubular body, such that the circumferentially continuous slot has a spiral configuration with a plurality of windings. The prosthesis is disposed within the capsule of the sheath in a radially compressed delivery state and is configured to deploy to an expanded state after release from the capsule of the sheath. The prosthesis includes a most flexible portion, and the middle region of the intermediate portion of the tubular body of the capsule is disposed over the most flexible portion of the prosthesis in the radially compressed delivery state.

[0018] In an aspect of the second embodiment, and in combination with any other aspects herein, the disclosure provides a pair of circumferentially opposing continuous longitudinal spines are formed on the tubular body along the distal region and along at least a portion of the proximal region.

[0019] In an aspect of the second embodiment, and in combination with any other aspects herein, the disclosure provides the proximal region extends between 40-50% of a total length of the intermediate portion, the middle region extends between 5-15% of the total length of the intermediate portion, and the distal region extends between 40-50% of the total length of the intermediate portion.

[0020] In an aspect of the second embodiment, and in combination with any other aspects herein, the disclosure provides the circumferentially continuous slot is singular and the middle region also includes a plurality of circumferentially discontinuous slots which each extend between 350 and 359 degrees around the tubular body. Each circumferentially discontinuous slot of the plurality of circumferentially discontinuous slots of the middle region is disposed between a pair of longitudinally adjacent windings of the singular circumferentially continuous slot.

[0021] In an aspect of the second embodiment, and in combination with any other aspects herein, the disclosure provides the circumferentially continuous slot includes a first circumferentially continuous slot and a second circumferentially continuous slot. Each of the first circumferentially continuous slot and the second circumferentially continuous slot extends more than 360 degrees around the tubular body and has a spiral configuration with a plurality of windings. Each winding of the first circumferentially continuous slot is disposed between a pair of longitudinally adjacent windings of the second circumferentially continuous slot.

[0022] In an aspect of the second embodiment, and in combination with any other aspects herein, the disclosure provides a pull wire having a proximal end attached to the handle and a distal end attached to the capsule. The pull wire is configured to be tensioned to bend the capsule.

[0023] In an aspect of the second embodiment, and in combination with any other aspects herein, the disclosure provides an inner shaft disposed within the central lumen of the sheath. The prosthesis is disposed over a distal portion of the inner shaft.

[0024] In an aspect of the second embodiment, and in combination with any other aspects herein, the disclosure provides the prosthesis is a prosthetic heart valve including a plurality of axial struts, the plurality of axial struts being the most flexible portion. At least two of the axial struts of the plurality of axial struts are commissure posts.

[0025] In an aspect of a third embodiment, the disclosure provides a method of delivering and deploying a prosthesis at a treatment site. A delivery system is introduced into the vasculature of a patient. The delivery system includes a delivery device and a prosthesis. The delivery device includes a handle, a sheath distally extending from the handle, and a capsule distally extending from the sheath. The sheath defines a central lumen there-through. The capsule has a tubular body with an intermediate portion having a plurality of ribs and a plurality of slots defined therein, with longitudinally adjacent ribs of the plurality of ribs being separated by a slot of the plurality of slots. The plurality of ribs and the plurality of slots substantially extend in a circumferential direction around a longitudinal axis of the capsule. The intermediate portion of the tubular body includes a proximal region, a distal region, and a middle region extending between the proximal region and the distal region. Each slot of the plurality of slots defined within each of the proximal and distal regions is circumferentially discontinuous and extends less than 180 degrees around the tubular body. At least one slot of the plurality of slots defined within the middle region is a circumferentially continuous slot that extends more than 360 degrees around the tubular body,such that the circumferentially continuous slot has a spiral configuration with a plurality of windings. The prosthesis is disposed within the capsule of the sheath in a radially compressed delivery state and is configured to deploy to an expanded state after release from the capsule of the sheath. The prosthesis includes a most flexible portion, and the middle region of the intermediate portion of the tubular body of the capsule is disposed over the most flexible portion of the prosthesis in the radially compressed delivery state. The delivery system is advanced through a curved region within the vasculature, and the middle region of the intermediate portion of the tubular body of the capsule bends to conform to the curved region within the vasculature.

[0026] In an aspect of the third embodiment, and in combination with any other aspects herein, the disclosure provides the prosthesis is a prosthetic heart valve including a plurality of axial struts, the plurality of axial struts being the most flexible portion. At least two of the axial struts of the plurality of axial struts are commissure posts.

[0027] In an aspect of a fourth embodiment, the disclosure provides a delivery device including a handle, a sheath distally extending from the handle, and a capsule distally extending from the sheath. The sheath defines a central lumen there-through. The capsule has a tubular body with an intermediate portion having a plurality of ribs and a plurality of slots defined therein, with longitudinally adjacent ribs of the plurality of ribs being separated by a slot of the plurality of slots. The plurality of ribs and the plurality of slots substantially extend in a circumferential direction around a longitudinal axis of the capsule. The intermediate portion of the tubular body includes a proximal region, a distal region, and a middle region extending between the proximal region and the distal region. Each slot of the plurality of slots defined within each of the proximal and distal regions is circumferentially discontinuous and extends less than 180 degrees around the tubular body. Each slot of the plurality of slots defined within the middle region is circumferentially discontinuous and extends between 350 and 359 degrees around the tubular body. A pair of circumferentially opposing continuous longitudinal spines are formed on the tubular body along the distal region and along at least a portion of the proximal region. A pair of circumferentially opposing discontinuous longitudinal spines are formed on the tubular body along the middle region.

[0028] In an aspect of the fourth embodiment, and in combination with any other aspects herein, the disclosure provides the proximal region extends between 40-50% of a total length of the intermediate portion, the middle region extends between 5-15% of the total length of theintermediate portion, and the distal region extends between 40-50% of the total length of the intermediate portion.

[0029] In an aspect of the fourth embodiment, and in combination with any other aspects herein, the disclosure provides each slot of the plurality of slots defined within the middle region has a first end, a second end opposing the first end, and a gap that extends between the first and second ends. The plurality of slots defined within the middle region include a first set of slots and a second set of slots, a slot of the first set of slots being disposed between a pair of longitudinally adjacent slots of the second set of slots. Gaps of the first set of slots are circumferentially opposed to gaps of the second set of slots.

[0030] In an aspect of the fourth embodiment, and in combination with any other aspects herein, the disclosure provides the capsule of the sheath is configured to retain a prosthesis in a radially compressed state therein.

[0031] In an aspect of the fourth embodiment, and in combination with any other aspects herein, the disclosure provides a pull wire having a proximal end attached to the handle and a distal end attached to the capsule. The pull wire is tensioned to bend the capsule.

[0032] In an aspect of the fourth embodiment, and in combination with any other aspects herein, the disclosure provides a proximal end of the capsule is attached to a distal end of the sheath.

[0033] In an aspect of the fourth embodiment, and in combination with any other aspects herein, the disclosure provides the capsule includes a circumferentially flaring feature configured to transition between a normal state and a flared sta te, a diameter of the circumferentially flaring feature being greater in the flared state than in the normal state. The capsule includes a shape memory' component constructed to naturally assume the normal stateBRIEF DESCRIPTION OF DRAWINGS

[0034] The foregoing and other features and advantages of the invention will be apparent from the following description of embodiments hereof as illustrated in the accompanying drawings. The accompanying drawings, which are incorporated herein and form a part of the specification, further serve to explain the principles of the invention and to enable a person skilled in the pertinent art to make and use the invention. The drawings are not to scale.

[0035] FIG. l is a side view of a delivery system according to an embodiment hereof, wherein the delivery system includes a capsule and the capsule is shown in a non-bent configuration.

[0036] FIG. 1 A is a cross-sectional view taken along line A-A of FIG. 1 .

[0037] FIG. 1 AA is a cross-sectional view taken along line A-A of FIG. 1 according to another embodiment hereof.

[0038] FIG. IB is a sectional view taken along line B-B of FIG. 1.

[0039] FIG. 2 is a side view of the delivery system of FIG. 1, wherein the capsule is shown in a bent configuration.

[0040] FIG. 3 A is a perspective side view of an exemplary prosthesis of the delivery system of FIG. 1, wherein the prosthesis is a heart valve prosthesis and is shown in an expanded or deployed configuration.

[0041] FIG. 3B depicts a top view of the heart valve prosthesis of FIG. 3 A.

[0042] FIG. 3C depicts a bottom view of the heart valve prosthesis of FIG. 3 A

[0043] FIG. 3D depicts a flat, expanded configuration of the heart valve prosthesis of FIG. 3A.

[0044] FIG. 3E depicts a flat, expanded configuration of a frame of the heart valve prosthesis of FIG. 3 A.

[0045] FIG. 3F depicts a side view of the frame of the heart valve prosthesis of FIG. 3A, wherein the frame is shown in an expanded or deployed configuration.

[0046] FIG. 3G is an illustrative view of a cut pattern of the frame of the heart valve prosthesis of FIG. 3 A.

[0047] FIG. 3H is a perspective side view of another exemplary prosthesis of the delivery system of FIG. 1, wherein the prosthesis is a transcatheter aortic valve prosthesis and includes three access cells and is shown in an expanded or deployed configuration.

[0048] FIG. 31 depicts a flat, expanded configuration of the transcatheter aortic valve prosthesis of FIG. 3H.

[0049] FIG. 3J depicts a side view of a frame of the transcatheter aortic valve prosthesis of FIG. 3H, wherein the frame is shown in an expanded or deployed configuration.

[0050] FIG. 3K depicts a flat, unexpanded configuration of the frame of the transcatheter aortic valve prosthesis of FIG. 3H.

[0051] FIG. 4 is a perspective view of the capsule of the delivery system of FIG. 1, wherein the capsule is removed from the remainder of the delivery system for illustrative purposes.

[0052] FTG. 5 is a side view of the capsule of FIG. 4, wherein the capsule is removed from the remainder of the delivery system for illustrative purposes and a circumferentially flaring feature of the capsule is shown in a non-flared state.

[0053] FIG. 6 is a side view of the capsule of FIG. 4, wherein the capsule is removed from the remainder of the delivery system for illustrative purposes and the circumferentially flaring feature of the capsule is shown in a flared state.

[0054] FIG. 7 is a side view of the capsule of FIG. 4, wherein the capsule is removed from the remainder of the delivery system for illustrative purposes, the capsule having a cut pattern including a proximal region, a distal region, and a middle region extending between the proximal and distal regions.

[0055] FIG. 8A is an illustrative view of the cut pattern of the capsule of FIG. 4, wherein the cut pattern includes two circumferentially continuous slots formed in the middle region thereof.

[0056] FIG. 8B is an enlarged view of the middle region of the cut pattern of FIG. 8A.

[0057] FIG. 8C is a schematic illustration of the two circumferentially continuous slots of FIG.8A.

[0058] FIG. 9 is a side view of a capsule according to another embodiment hereof, wherein the capsule is removed from the remainder of the delivery system for illustrative purposes, the capsule having a cut pattern including a proximal region, a distal region, and a middle region extending between the proximal and distal regions.

[0059] FIG. 10A is an illustrative view of a cut pattern of the capsule of FIG. 9, wherein the cut pattern includes a singular circumferentially continuous slot and a plurality of circumferentially discontinuous slots formed in the middle region thereof.

[0060] FIG. 10B is an enlarged view of the middle region of the cut pattern of FIG. 10A.

[0061] FIG. 10C is a schematic illustration of the singular circumferentially continuous slot and the plurality of circumferentially discontinuous slots of FIG. 10A.

[0062] FIG. 11 is a side view of a capsule according to another embodiment hereof, wherein the capsule is removed from the remainder of the delivery system for illustrative purposes, the capsule having a cut pattern including a proximal region, a distal region, and a middle region extending between the proximal and distal regions.

[0063] FIG. 12A is an illustrative view of a cut pattern of the capsule of FIG. 11, wherein the cut pattern includes a plurality of circumferentially discontinuous slots formed in the middle region thereof.

[0064] FIG. 12B is an enlarged view of the middle region of the cut pattern of FIG. 12A.

[0065] FIG. 12C is a schematic illustration of the plurality of circumferentially discontinuous slots of FIG. 12 A.

[0066] FIG. 13 is a side view of a distal portion of die delivery system of FIG. I being advanced in situ to a native aortic valve.DETAILED DESCRIPTION OF THE INVENTION

[0067] Specific embodiments of the present invention are now described with reference to the figures, wherein like reference numbers indicate identical or functionally similar elements. The terms “distal” and “proximal”, when used in the following description to refer to a sheath, a delivery device, or a catheter-based delivery system are with respect to a position or direction relative to the treating clinician. Thus, “distal” and “distally” refer to positions distant from, or in a direction away from the treating clinician, and the terms “proximal” and “proximally” refer to positions near, or in a direction toward the treating clinician. The terms “distal” and “proximal”, when used in the following description to refer to a device to be implanted into a 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 positions in a downstream direction with respect to the direction of blood flow, and the terms “proximal” and “proximally” refer to positions in an upstream direction with respect to the direction of blood flow.

[0068] 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. Furthermore, there is no intention to be bound by any expressed or implied theory presented in the preceding technical field, background, brief summary, or the following detailed description.

[0069] Embodiments hereof relate to a delivery device 100 for delivering a prosthesis 101. The delivery device 100 and the prosthesis 101 may collectively be referred to herein as a delivery system. During delivery within a patient’s vasculature, the prosthesis 101 is held or disposed in a radially compressed delivery state within a capsule 112 of the delivery device 100. The delivery device 100 is configured to retain the prosthesis 101 in the radially compressed state for delivery to a treatment site, such as a native aortic valve or a native mitral valve. The delivery device 100is further configured to release the prosthesis 101 at a treatment site and the prosthesis 101 is configured to deploy to an expanded state after release from the capsule 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 in accordance with embodiments hereof.

[0070] The delivery device 100 includes a tubular shaft or sheath 102 and a handle 150 coupled to and proximally extending 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 capsule 112 is attached to the distal end 106 of the sheath 102 such that the capsule 112 distally extends from the sheath 102. FIG. 1 is a side view of the delivery device 100 with the capsule 112 in a straight or non-bent configuration, while FIG. 2 is a side view of the delivery device 100 with the capsule 112 in a curved or bent configuration. More particularly, as will be described in more detail herein, the capsule 112 includes a middle region having higher flexibility and increased bendability than the remainder of the body of the capsule 112, and the middle region is configured to be disposed over the portion of the prosthesis 101 with the highest or greatest flexibility. By overlapping or overlaying the middle region of the capsule 112 with the portion of the prosthesis 101 with the highest flexibility, the delivery device 100 is particularly configured to curve or bend within curved anatomy, such as but not limited to the aortic arch. The dimension of the curvature of the capsule 112 in the curved or bent configuration depends upon the target anatomy for use of the delivery device 100, and / or the size or profile of the delivery device 100. In an embodiment in which the delivery device 100 is utilized in a TAVI or transcatheter aortic valve implantation procedure, the radius of curvature of the capsule 112 in the curved or bent configuration ranges between twenty (20) millimeters and sixty (60) millimeters.

[0071] The sheath 102 may be formed of one or more polymeric materials, non-exhaustive examples of which include polyethylene, polyethylene block amide copolymer (PEBA), polyamide and / or combinations thereof, either laminated, blended or co-extruded. Optionally, the sheath 102 or some portion thereof may be formed as a composite having a reinforcement layer incorporated within a polymeric body in order to enhance strength and / or flexibility and / or torquability. Suitable reinforcement layers include braiding, wire mesh layers, embedded axial wires, embedded helical or circumferential wires, hypotubes, and the like. In one embodiment, forexample, at least a proximal portion of the sheath 102 may be formed from a reinforced polymeric tube.

[0072] As best shown on FIG. 1A, which is a cross-sectional view of the sheath 102 of FIG. 1 taken along line A-A of FIG. 1, the sheath 102 defines a central lumen 108 extending therethrough, i.e., from the proximal end 104 to the distal end 106 thereof. The central lumen 108 is sized or configured to house an inner shaft 146. The sheath 102 is slidably disposed over the inner shaft 146. The inner shaft 146 is a tubular component defining a central lumen 148 there-through. In an embodiment, the central lumen 148 may be configured to slidably receive a guidewire (not shown) therethrough. A proximal end (not shown) of the inner shaft 146 is attached or secured within the handle 150. In an embodiment, the inner shaft 146 is longitudinally reinforced with one or more axial wires 149A, 149B. More particularly, 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 as well as the axial wires 149A, 149B that are disposed at circumferentially opposing locations. The braid 147 can be a conventional metal braid (e.g., stainless steel braiding) and in other embodiments can be omitted. The axial wires 149A, 149B can be made of a structurally robust material, such as stainless steel, and have the flattened or rectangular shape in some embodiments as illustrated. While other shapes are also acceptable, the flattened construction provides more mass and thus an enhanced steerability.

[0073] Although not required, in an embodiment hereof, the delivery device 100 may include a pull wire 140 configured to be selectively tensioned by the user to bend the capsule 112. FIG. 1AA depicts a cross-sectional view of the sheath 102 according to an alternative embodiment hereof in which the delivery system includes the pull wire 140. A proximal end of the pull wire 140 is attached to the handle 150 and a distal end is attached to the capsule 112. As shown on FIG. 1AA, the sheath 102 may define a longitudinally-extending lumen 110 is formed with a wall of the sheath 102. In an embodiment, the longitudinally-extending lumen 110 is pre-formed in the wall of the sheath 102 and may be formed for example by multi-lumen profile extrusion. The longitudinally-extending lumen 110 houses the pull wire 140. In embodiments hereof, the longitudinally-extending lumen 110 may have an oblong cross-section in order to accommodate the pull wire 140, which may have a flat or flattened longitudinal profile. In another embodiment (not shown), the longitudinally-extending lumen 110 as well as the pull wire 140 disposed therethrough may have different configurations or shapes including oval or circular. The pull wire 140is slidably disposed within the longitudinally-extending lumen 1 10 such that it may be selectively tensioned by the user to bend the capsule 112. As used herein, “slidably” denotes back and forth movement in a longitudinal direction along or generally parallel to a central longitudinal axis LA of the delivery device 100. While the pull wire 140 is primarily housed or disposed within the longitudinally-extending lumen 110 of the sheath 102, the proximal end 142 proximally extends beyond the proximal end 104 of the sheath 102 and is accessible via the handle 150 to be pulled or pushed which results in controlled bending movement of the capsule 112. Tension is applied to the pull wire 140 in order to bend the capsule 112 as desired and thereby steer the delivery device 100 within the vasculature as the delivery device 100 is being advanced through the vasculature to the treatment site. As the delivery device 100 is advanced over the aortic arch, the pull wire 140 is tensioned in order to bend the capsule 112 and steer the delivery device over the aortic arch. Although the pull wire 140 may be tensioned to bend the capsule 112, the pull wire 140 is not required. Since the capsule 112 includes a middle region having higher flexibility and increased bendability relative to the remainder of the intermediate portion of the capsule, as will be described in more detail below, and the middle region is configured to overlap, overlay, cover or otherwise be disposed over a most flexible portion of the prosthesis 101, as will be described in more detail below, the capsule 112 is configured to bend during advancement within curved anatomy in situ without the use of the pull wire 140. However, if present, the pull wire 140 may be utilized to assist and / or control bending of the capsule 112.

[0074] The handle 150 includes a first actuator mechanism 152 for retracting the capsule 112. The handle 150 can have any shape or size appropriate for convenient handling by a user. The first actuator mechanism 152 is coupled to the sheath 102, and is generally constructed to provide selective proximal retraction and distal advancement of the sheath 102, and particularly of the capsule 112 attached thereto, relative to the prosthesis 101 held in a radially compressed, delivery state therein for covering and uncovering the prosthesis 101. The first actuator mechanism 152 may assume any construction that is capable of providing the desired sheath actuation functionality, such as those described in U.S. Patent No. 8,579,963 to Tabor, which is assigned to the same assignee as the present disclosure and which is herein incorporated by reference in its entirety.

[0075] When / if the pull wire 140 is present, the handle 150 includes a second actuator mechanism 154 for tensioning the pull wire 140. The second actuator mechanism 154 is coupledto the proximal end of the pull wire 140, and is generally constructed to provide selective proximal retraction and distal advancement of the proximal end of the pull wire 140. Stated another way, the second actuator mechanism is coupled to the proximal end of the pull wire 140 and is constructed to selectively push or pull the pull wire 140. The second actuator mechanism 154 may assume any construction that is capable of providing the desired pull wire actuation functionality, such as those described in U.S. Patent No. 10,278,852 to Griffin, which is assigned to the same assignee as the present disclosure and which is herein incorporated by reference in its entirety.

[0076] FIG. IB is a sectional view taken along line B-B of FIG. 1, and illustrates the prosthesis 101 loaded within the capsule 112 of the delivery device 100. FIG. 3 A is a perspective side view of the prosthesis 101 in an expanded or deployed configuration. FIG. 3B depicts a top view of the prosthesis 101; FIG. 3C depicts a bottom view of the prosthesis 101; and FIG. 3D depicts a flat, expanded configuration of the prosthesis 101. The prosthesis 101 is a heart valve prosthesis which is more fully described in U.S. Patent No. 12,144,728 B2 to Baldwin et al., which is assigned to the same assignee as the present disclosure and which is herein incorporated by reference in its entirety. In embodiments hereof, any of the heart valve prostheses disclosed in U.S. Patent No. 12,144,728 B2 to Baldwin et al. may be delivered and deployed by the delivery device 100 described herein. Further, as stated above, 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 in accordance with embodiments hereof.

[0077] In general terms, the prosthesis 101 includes a stent-like frame 360 for supporting a valve structure 362, which generally includes two or more leaflets 364. The stent-like frame 360 is a generally tubular support structure having an internal area or lumen within which the valve structure 362 having leaflets 364 will be secured. The valve structure 362 may be constructed from tissue and / or synthetic materials, as would be known to one of ordinary skill in the art. The stentlike frame 360 is constructed from a shape memory material so as to be configured to self-expand or return to the deployed state of FIG. 3A, when released from the capsule 112 of the delivery device 100. In the embodiment of FIGS. 3A-3G, the prosthesis 101 is configured for replacing or repairing a native aortic valve. Alternatively, other shapes are also envisioned, adapted to the specific anatomy of the valve to be repaired (e.g., prosthetic heart valves in accordance with the present disclosure can be shaped and / or sized for replacing a native mitral, pulmonic, or tricuspid valve).

[0078] The frame 360 is best depicted in FIGS. 3E-3G. FIG. 3E depicts a flat, expanded configuration of the frame 360; FIG. 3F depicts a side view of the frame 360; and FIG. 3G is an illustrative view of a cut pattern of the frame 360. The frame 360 secures the prosthesis 101 in place in situ within the vasculature of the patient. The frame 360 has an inflow end 380 and an outflow end 382. The frame 360 includes a plurality of struts that are arranged to form a plurality of cells arranged circumferentially around a longitudinal axis LA of the prosthesis 101 and longitudinally to form a tubular structure.

[0079] In the embodiment shown, the plurality of cells include a plurality of first cells 368 and one or more access cells 366. The first cells 368 and the access cells 366 are defined as the open spaces or windows formed between the plurality of struts. The one or more access cells 366 each have an enlarged area relative or compared to the first cells 368. The access cells 366 are enlarged cells configured to provide improved access to a patient’s percutaneous coronary arteries if a percutaneous coronary intervention procedure is required post-implantation of prosthesis 101. Each first cell 368 of the plurality of first cells 368 are formed by four struts and are generally diamond-shaped. In embodiments, the plurality of first cells 368 vary in size depending on the position of the first cell 368 within the frame 360, i.e., row placement and / or longitudinal position on the frame 360. For example, in some embodiments, the plurality of first cells 368 disposed near the inflow end 380 and the outflow end 382 of the frame 360 may be larger than the plurality of first cells 368 disposed at a midline or midportion of the frame 360. In other embodiments, the plurality of first cells 368 disposed near the outflow end 382 of the frame 360 may be larger than the plurality of first cells 368 disposed near the inflow end 380 of the frame 360. In the embodiment described herein, each access cell 366 is always larger than each first cell 368 of the plurality of first cells 368.

[0080] Each access cell 366 is formed in part by a pair of adjacent axial struts 384, each of which extends generally parallel to the longitudinal axis LA of the prosthesis 101. In an embodiment, the frame 310 includes a total of exactly six axial struts 384 and six access cells 366. Three of the six axial struts 384 form commissure posts 388 which have leaflet commissures attached thereto, as described in more detail below. The commissure posts 388 are located on every other axial strut 384, as can best be seen in FIG. 3D.

[0081] The valve structure 362 is disposed within and coupled to an interior surface of the frame 360. In an embodiment, the valve structure 362 includes three valve leaflets 364.Alternatively, the valve structure 362 of the prosthesis 101 may include one valve leaflet 364 or two leaflets 364. This embodiment may include a skirt as described in U.S. Patent No. 12,144,728 B2 to Baldwin et al., previously incorporated by reference, but the skirt is not shown herein for sake of clarity. The three valve leaflets 364 may be sewn using sutures or otherwise securely attached along their bases to the skirt at a margin of attachment (not shown). The valve structure 362 is configured to block flow in one direction to regulate flow therethrough via the valve leaflets 364 that form a replacement bicuspid or tricuspid valve. FIG. 3B depicts a top view of the outflow end 382 of the prosthesis 101. FIG. 3B illustrates the configuration of the three valve leaflets 364 within the central lumen 320 of the prosthesis 101. FIG. 3C depicts a bottom view of the inflow end 380 of the prosthesis 101. The valve structure 362 can be coupled to the frame 360 in any suitable manner known in the art, such as sewing the valve structure 362 to the frame 360 using sutures (not shown). Adjoining pairs of valve leaflets 364 are attached to one another at their lateral ends to form commissures 386. Three of the six axial struts 384 act as commissure posts 388 that align with and attach to a respective commissure 386 of the three valve leaflets 364 of the valve structure 362. The valve structure 362 may be formed of various flexible materials including, but not limited to natural pericardial material such as tissue from bovine, equine or porcine origins, or synthetic materials such as polytetrafluoroethylene (PTFE), DACRON® polyester, pyrolytic carbon, or other biocompatible materials. With certain prosthetic leaflet materials, it may be desirable to coat one or both sides of the replacement valve leaflet with a material that will prevent or minimize overgrowth. It is further desirable that the prosthetic leaflet material is durable and not subject to stretching, deforming, or fatigue.

[0082] FIGS. 3H-3K depict another embodiment of a prosthesis 301H that may be delivered by the delivery device 100. The prosthesis 301H includes a frame 360H having three enlarged access cells 366H. FIG. 3H is a perspective side view of prosthesis 301H and is shown in an expanded or deployed configuration in FIG. 3H, and FIG. 31 depicts a flat, expanded configuration of the prosthesis 301H. FIG. 3J depicts a side view of the frame 360H only, in an expanded or deployed configuration, and FIG. 3K depicts a flat, unexpanded configuration of the frame 360H. Prosthesis 301H is more fully described in U.S. Patent Pub. No. 12,144,728 B2 to Baldwin et al, previously incorporated by reference.

[0083] As best shown in FIG. 3H, the prosthesis 301H includes the frame 360H having an inflow end 380H and an outflow end 382H, and a valve structure 362H disposed within andattached to the frame 360H. The valve structure 362H may be constructed from tissue and / or synthetic materials, as would be known to one of ordinary skill in the art. The frame 360H is constructed from a shape memory material so as to be configured to self-expand or return to the deployed state of FIG. 3H, when released from the capsule 112 of the delivery device 100.

[0084] The frame 360H of the prosthesis 301H includes a plurality of struts that are arranged to form a plurality of cells arranged circumferentially around a longitudinal axis LA of the prosthesis 301H and longitudinally to form a tubular structure. In the embodiment shown, the plurality of cells include a plurality of first cells 368H and one or more second or access cells 366H. The first cells 368H and the access cells 366H are defined as the open spaces or windows formed between the plurality of struts. The access cells 366H each have an enlarged area relative or compared to the first cells 368H. The access cells 366H are configured to improve access to a patient’s percutaneous coronary arteries if a percutaneous coronary intervention procedure is required post -implantation of prosthesis 301H. In an embodiment, each enlarged access cell has an area that is relatively larger than a cell directly adjacent thereto, which has an area between approximately 12% and approximately 33% of the area of the enlarged access cell 366H.

[0085] Each first cell 368H of the plurality of first cells 368H are formed by four struts and are generally diamond-shaped. In embodiments, the plurality of first cells 368H vary in size depending on the position of the first cell 368H within the frame 360H, i.e. , row placement and / or longitudinal position on the frame 360H. For example, in some embodiments, the plurality of first cells 368H disposed near the inflow end 380H and the outflow end 382H of the frame 360H are larger than the plurality of first cells 368H disposed at or near a midline or midportion of the frame 360H. In other embodiments, the plurality of first cells 368H disposed near the outflow end 382H of the frame 360H are larger than the plurality of first cells 368H disposed near the inflow end 380H of the frame 360H. In the embodiment described herein, each access cell 366H is larger in size than each first cell 368H of the plurality of first cells 368H. In this embodiment, as shown best in FIG. 3 J, the area of the at least one access cell 366H is approximately equivalent to the area of four first cells 368H combined, specifically the first cells 368H disposed directly adjacent to at least one of the access cells 366H. Stated another way, the area of an access cell 366H compared to the area of a first cell 368H directly adjacent to at least one of the access cells 366H is approximately a 4: 1 ratio. In this embodiment, a first cell 368H adjacent to at least one of the access cells 366H has an area that is approximately 25% of an area of one of the access cells 366H of the frame 360H, with“approximately” including a tolerance of 5%. In another embodiment, a first cell 368H adjacent to at least one of the access cells 366H has an area that is between 20% and 25% of an area of one of the access cells 366H of the frame 360H. The size of the access cell 366H and the size of the first cell 368H directly adjacent thereto depends on the overall size of the prosthesis 301H. For example, transcatheter aortic valve prostheses typically are manufactured in several sizes, such as 23 mm, 26 mm, 29 mm and / or 34 mm. Depending on the size of the prosthesis 301H, the area of the access cell 366H can range from between 70-115 mm2and the area of the first cell 368H can range between 14-26 mm2.

[0086] The valve structure 362H is disposed inside and coupled to an interior surface of the frame 360H of the prosthesis 301H, and includes three valve leaflets 364H and a skirt 365H. The skirt 365H directs blood flow through the central lumen of the prosthesis 301H and to the valve leaflets 364H of the valve structure 362H. In the embodiment shown, the three valve leaflets 364H are securely attached along their bases to the skirt 365H at a margin of attachment. Adjoining pairs of valve leaflets 364H are attached to one another at their lateral ends to form leaflet commissures 333H. Alternatively, the prosthesis 301H may include one valve leaflet 364H or two leaflets 364H. The valve structure 362H is configured to block flow in one direction to regulate flow therethrough via the valve leaflets 364H that form a replacement bicuspid or tricuspid valve. The valve structure 362H can be coupled to the interior surface of the frame 360H through any suitable manner known in the art, such as sewing the valve structure 362H to the frame 360H using sutures. The valve structure 362H may be formed of various flexible materials including, but not limited to natural pericardial material such as tissue from bovine, equine or porcine origins, or synthetic materials such as polytetrafluoroethylene (PTFE), DACRON® polyester, pyrolytic carbon, or other biocompatible materials. With certain prosthetic leaflet materials, it may be desirable to coat one or both sides of the replacement valve leaflet with a material that will prevent or minimize overgrowth. It is further desirable that the prosthetic leaflet material is durable and not subject to stretching, deforming, or fatigue.

[0087] In the embodiment shown, the frame 360H of the prosthesis 301H includes exactly three access cells 366H, as shown in the flat, expanded configuration of the prosthesis 301H in FIG. 31. Each of the three access cells 366H are centered in a circumferential direction between two commissure cells 388H, as shown in FIG. 31. The frame 360H includes exactly three commissure cells 388H, which are first cells 368H that have the leaflet commissures attached thereto. Inembodiments, the three valve leaflets 364H are attached to one another, as well as the frame 360H, at three commissure cells 388H, as shown best in FIG. 31. Each commissure cell 388H includes a material pad that spans or bridges the commissure cell. Each material pad forms a base or support to which a respective commissure of the three leaflets 364H of the prosthetic valve is attached. Thus, the three commissure cells 388H are aligned with and attached to a respective commissure of the three leaflets 364H of the valve structure 362H. Each material pad may be generally diamond in shape. The material pad may be formed from a material such as those suitable for the skirt 365H, such as but not limited to natural pericardial material such as tissue from bovine, equine or porcine origins, or synthetic materials such as polytetrafluoroethylene (PTFE), DACRON® polyester, pyrolytic carbon, or other biocompatible materials.

[0088] Turning now to FIG. 4, the capsule 112 according to an embodiment hereof will now be described in more detail. The capsule 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. An intermediate portion 122 of the tubular body 114 includes a plurality of slots 126 separated, or demarcated, by a plurality of ribs 124, such that generally each rib 124 is separated from an adjacent rib 124 by a slot 126. The plurality of ribs 124 and the plurality of slots 126 substantially extend in a circumferential direction around the central longitudinal axis LA of the delivery device 100. The plurality of ribs 124 and the plurality of slots 126 are formed via laser-cutting the tubular body 114 and are configured to impart nonkinking flexibility to the capsule 112 that allows the capsule 112 to bend when the capsule 112 is advanced through curved anatomy.

[0089] For example, in use, the delivery device 100 is manipulated to advance the compressed prosthesis 101 toward the implantation target site in a retrograde manner through a cut-down to the femoral artery, into the patient's descending aorta. The delivery device 100 is then advanced, under fluoroscopic guidance, over the aortic arch, through the ascending aorta, and approximately midway across the defective aortic valve (for an aortic valve replacement procedure). As the delivery device 100 is advanced over the aortic arch, the capsule 112 bends in order to be advanced though over the aortic arch. Once positioning of the delivery device 100 is complete, the capsule 112 is retracted to deploy the prosthesis 101 to its expanded or deployed state at the treatment site.

[0090] FIGS. 5 and 6 illustrate side views of the capsule 112 removed from the remainder of the delivery device 100. The proximal end 118 of the capsule 112 is configured for mounting tothe distal end 106 of the sheath 102 and in some constructions includes a plurality of circumferentially-spaced fingers 170, each terminating at a proximal end 172. In some constructions, the proximal end 172 of each of the fingers 170 can have an enlarged width as shown. Regardless, the spaced fingers 170 are readily interposed within (alternatively over) the distal end 106 of the sheath 102 so as to facilitate attachment thereto (e.g., adhesive bond, heated fusing, etc.).

[0091] The distal end 120 of the capsule 112 includes a circumferentially flaring feature 138 configured to transition between a normal or non -flared state to a flared state when subjected to an expansion force, and self-transitioning back toward the normal state when the expansion force is removed. In this regard, the circumferentially flaring feature 138 is specifically constructed so as to reduce the force required to recapture a partially-deployed prosthesis 101, while increasing the axial strength and buckling resistance of the capsule 112. In FIG. 5, the circumferentially flaring feature 138 of the capsule is shown in the non-flared state while in FIG. 6, the circumferentially flaring feature 138 of the capsule is shown in the flared state. A diameter of the circumferentially flaring feature 138 is greater in the flared state than in the normal or non-flared state. At least the circumferentially flaring feature 138 of the capsule 112 is formed from a shape memory material such as Nitinol and facilitates repeatable transitioning of the capsule 112 between the non-flared state of FIG. 5 to the flared state of FIG. 6. In this regard, various shape memory materials can be used for the capsule 112, such as a steel, polymers, etc. In some embodiments, the capsule 112 is a Nitinol material, and in particular a Nitinol super elastic material. The circumferentially flaring feature 138 is useful during recapture of the prosthesis 101 during implantation, and is further described in more detail in U.S. Patent No. 8,562,673 to Yeung et al., which is assigned to the same assignee as the present disclosure and which is herein incorporated by reference in its entirety.

[0092] In addition to the plurality of ribs 124 and the plurality of slots 126, the intermediate portion 122 of the capsule 112 can include additional one or more reflow zones 123 A, 123B. A first reflow zone 123A is disposed between the distal end 120 and the cut pattern of ribs 124 / slots 126, and a second reflow zone 123B is disposed between the proximal end 118 and the cut pattern of ribs 124 / slots 126. In an embodiment, the capsule 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 are reflowed during manufacture, and the reflow zones 123 A, 123B allow reflowmaterial (material of the inner and outer polymeric layers in semi liquid form) to pass therethrough. As a result, the inner and outer polymeric layers fuse or join together during the reflow process in order to encapsulate the capsule 112. In an embodiment, each of the reflow zones 123 A, 123B include a plurality of circumferentially spaced apart holes in the form of a ring. In an embodiment, each of the reflow zones 123 A, 123B includes at least two rings of circumferentially spaced apart holes. In an embodiment, reflow zone 123 A includes exactly two rings of circumferentially spaced apart holes while reflow zone 123B includes exactly three rings of circumferentially spaced apart holes. Further, in an embodiment, the diameter of the holes of the reflow zone 123B are greater or larger than the diameter of the holes of the reflow zone 123 A. Other constructions of the reflow zones 123 A, 123B are also acceptable, and in some embodiments, one or more of the reflow zones 123 A, 123B can be omitted.

[0093] Turning now to FIGS. 7, 8A, 8B, and 8C, the intermediate portion 122 of the tubular body 114 of the capsule 112 will be described in more detail. The intermediate portion 122 of the tubular body 114 is longitudinally disposed between the proximal end 118 of the capsule 112 and the distal end 120 of the capsule 112. In general terms, the intermediate portion 122 incorporates features that impart circumferential or radial rigidity, yet permit or promote transverse articulation, designed to give the capsule 112 adequate axial and radial strength to prevent buckling or kinking. As described herein, in embodiments hereof, the intermediate portion 122 of the tubular body 114 incorporates features that impart circumferential or radial rigidity, yet permit or promote transverse articulation, designed to give the capsule 112 adequate axial and radial strength to prevent buckling or kinking when being bent or curved as the capsule 112 is being advanced in situ through the vasculature. The capsule 112 includes, along the intermediate portion 122, a cut pattern (of the plurality of slots 126) that establishes the plurality of generally circumferentially extending ribs 124. The cut pattern of the capsule 112 results in reduced bending stiffness of the capsule while maintaining column stiffness.

[0094] The cut pattern of the intermediate portion 122 may be considered to include three longitudinal sections or regions including a proximal region 734, a distal region 730, and a middle region 732 extending between the proximal region 734 and the distal region 730. The proximal region 734 includes a first proximal region 734A and a second proximal region 734B, which are collectively referred to herein as the proximal region 734. The proximal, middle, and distal regions 734, 732, 730, respectively, are clearly shown on FIG. 7. In an embodiment, the proximal region734 extends between 30-60% of the total length of the intermediate portion 122, the middle region 732 extends between 5-20% of the total length of the intermediate portion 122, and the distal region extends between 30-60% of the total length of the intermediate portion 122. In another embodiment, the proximal region 734 extends between 40-50% of the total length of the intermediate portion 122, the middle region 732 extends between 5-15% of the total length of the intermediate portion 122, and the distal region extends between 40-50% of the total length of the intermediate portion 122.

[0095] In an embodiment, the cut pattern (of the plurality of slots 126) that establishes the plurality of generally circumferentially extending ribs 124 of the first proximal region 734A and the distal region 730 is the same. More particularly, in an embodiment, within each of the first proximal region 734A and the distal region 730, each pair of longitudinally adjacent ribs 124 is separated by a slot 126. As such, within each of the first proximal region 734A and the distal region 730, slots 126 are helically aligned but are separated from one another. Each slot 126 of the plurality of slots 126 defined within each of the first proximal region 734A and the distal region 730 is circumferentially discontinuous and extends less than 180 degrees around the tubular body 114 such that a pair of longitudinal spines 128 are formed on the tubular body 114 circumferentially opposing one another. In an embodiment, each slot 126 of the plurality of slots 126 defined within each of the first proximal region 734A and the distal region 730 extends between 160 degrees and 178 degrees around the tubular body 114. The two longitudinal spines 128 are formed circumferentially opposing one another (it being understood that only one of the spines 128 is visible within each of the first proximal region 734A and the distal region 730 on FIG. 7). Within each of the first proximal region 734A and the distal region 730, the spines 128 generally connect or maintain adjacent ribs 124 relative to one another, yet permit transverse articulation so that the capsule 112 is bendable around the anatomy in situ. While being flexible for requisite bending or articulation (due to a material strength, thickness, and circumferential width), the spines 128 in combination with the ribs 124 provide an enhanced hoop strength attribute to the intermediate portion 122, to constrain the prosthesis 101 in the collapsed arrangement as well as longitudinal or axial stability for distally advancing the capsule 112 over a partially deployed (and radially expanded) prosthesis 101. With these and other embodiments, the capsule 112 can be configured to readily identify a location of the spines 128 to a user.

[0096] Within the second proximal region 734B, each pair of longitudinally adjacent ribs 124 is separated by a slot 126. As such, the second proximal region 734B, slots 126 are helically aligned but are separated from one another. Each slot 126 of the plurality of slots 126 defined within each of the second proximal region 734B is circumferentially discontinuous and extends less than 180 degrees around the tubular body 114. In an embodiment, each slot 126 of the plurality of slots 126 defined within the second proximal region 734B extends between 160 degrees and 178 degrees around the tubular body 114. However, unlike the first proximal region 734A, each slot 126 within the proximal region 734B is circumferentially offset by approximately ninety degrees from a longitudinally-adjacent slot. As such, along the second proximal region 734B, a total of four discontinuous spines 128B are formed on the tubular body 114 at circumferentially spaced apart locations, i.e., approximately ninety degrees from each other (it being understood that only two of the discontinuous spines 128B are visible within the second proximal region 734B on FIG. 7). Within second proximal region 734B, the discontinuous spines 128B generally connect or maintain adjacent ribs 124 relative to one another, yet permit transverse articulation so that the capsule 112 is bendable around the anatomy in situ. Due to the nature of the discontinuous spines, the second proximal region 734B has a higher flexibility than the first proximal and distal regions 734A, 730, respectively, yet maintains a high degree of longitudinal or axial stability.

[0097] Although depicted with first and second proximal regions 734A, 734B, the proximal region 732 may be formed with the same cut pattern along its length. Stated another way, in an embodiment, the full length of the proximal region 732 may have the cut pattern of the first proximal region 734A. In another embodiment, the full length of the proximal region 732 may have the cut pattern of the second proximal region 734B.

[0098] In the embodiment of FIGS. 7- 8C, the middle region 732 includes two circumferentially continuous slots 790A, 790B which each extend the entire length of the middle region 732. FIG. 8A is an illustrative view of the cut pattern of the capsule 112; FIG. 8B is an enlarged view of the middle region 732 of the cut pattern of the capsule 112; and FIG. 8C is a schematic illustration of the two circumferentially continuous slots 790A, 790B. For sake of illustration only, slot 790A is referred to herein as the first circumferentially continuous slot and slot 790B is referred to herein as the second circumferentially continuous slot. Each circumferentially continuous slot 790A, 790B extends more than 360 degrees around the tubular body 114 such that each circumferentially continuous slot 790A, 790B has a spiral configuration with a plurality of windings 792A, 792B,respectively. Each winding 792A, 792B of the circumferentially continuous slot 790A, 790B, respectively, may be considered a single 360 degree revolution of the respective circumferentially continuous slot. Each winding 792A of the first circumferentially continuous slot 790A is disposed between a pair of windings 792B formed by the second circumferentially continuous slot 790B, and each winding 792B of the second circumferentially continuous slot 790B is disposed between a pair of windings 792A formed by the first circumferentially continuous slot 790A. Stated another way, the circumferentially continuous slots 790A, 790B are disposed in an interwoven or interleaved manner such that the windings thereof alternate with one another. In an embodiment, each circumferentially continuous slot 790A, 790B includes between 5 and 10 windings 792A, 792B, respectively. The windings 792A, 792B of each circumferentially continuous slot 790A, 790B, respectively, are helically aligned and are continuous with each other (i.e., are not separated from one another). As such, along the middle region 732, there is no longitudinal spine formed on the tubular body 114. Rather, longitudinal spines are formed only on the proximal and distal regions 734, 730, respectively. Due to the absence of the longitudinal spines, and the continuous nature of the circumferentially continuous slots 790A, 790B, the middle region 732 has a higher flexibility than the proximal and distal regions 734, 730, respectively. The higher flexibility of the middle region 732 permits greater transverse articulation of the capsule 112 along the middle region 732 thereof. The higher flexibility of the middle region 732 results in the capsule 112 having increased bendability and trackability as compared to a capsule in which the middle region 732 has the same or similar cut pattern as the proximal and distal regions 734, 730, respectively.

[0099] The middle region 732 is configured to overlap, overlay, cover or otherwise be disposed over a most flexible portion of the prosthesis 101, for example, a portion of higher flexibility than adjacent portions or a portion having the greatest flexibility of the prosthesis 101. In one embodiment, the flexible (e.g., most flexible) portion may be a portion including the commissure attachment points (e.g., commissure posts or pads). In another embodiment, the flexible portion may be a portion with the lowest density of frame struts (e.g., by cross-sectional number or area). In another embodiment, the flexible portion may be a portion wherein struts of the prosthesis are substantially parallel to the longitudinal axis of the prosthesis (e.g., within 10 degrees or within 5 degrees of parallel). In one embodiment, with respect to the prosthesis 101, the flexible portion may comprise or consist of the portion of prosthesis 101 having the axial struts 384. More particularly, when the prosthesis 101 is disposed within the capsule 112 during delivery, themiddle region 732 is longitudinally aligned with the flexible portion (e.g., axial struts 384) of the prosthesis 101. When being tracked through a curved region within the vasculature, the flexible portion functions as a hinge of the frame 360 of the prosthesis. With the highly flexible middle region 732 of the capsule 112 disposed over this hinge, the capsule 112 and the frame 360 are particularly configured to bend along the middle region 732 as needed to conform to the curved region within the vasculature. With respect to the prosthesis 301H, the flexible portion may comprise or consist of the portion including the access cells 366H. By overlapping or overlaying the middle region 732 of the capsule 112 with the portion including the access cells 366H, the delivery device 100 is particularly configured to curve or bend when being tracked through a curved region within the vasculature.

[0100] Turning now to FIGS. 9, 10A, 10B, and 10C, a capsule 912 according to an alternative embodiment is shown. The capsule 912 may be utilized as the capsule of the delivery device 100. The capsule 912 is similar to the capsule 112 except for the differences described herein. An intermediate portion 922 of a tubular body 914 of the capsule 912 is longitudinally disposed between a proximal end 918 of the capsule 912 and a distal end 920 of the capsule 912. In general terms, the intermediate portion 922 incorporates features that impart circumferential or radial rigidity, yet permit or promote transverse articulation, designed to give the capsule 912 adequate axial and radial strength to prevent buckling or kinking. As described herein, in embodiments hereof, the intermediate portion 922 of the tubular body 914 incorporates features that impart circumferential or radial rigidity, yet permit or promote transverse articulation, designed to give the capsule 912 adequate axial and radial strength to prevent buckling or kinking when being bent or curved as the capsule 912 is being steered in situ through the vasculature. The capsule 912 includes, along the intermediate portion 922, a cut pattern (by a plurality of slots 926) that establishes a plurality of generally circumferentially extending ribs 924. The cut pattern of the capsule 912 results in reduced bending stiffness of the capsule while maintaining column stiffness.

[0101] The cut pattern of the intermediate portion 922 may be considered to include three integral sections or regions including a proximal region 934, a distal region 930, and a middle region 932 extending between the proximal region 934 and the distal region 930. The proximal region 934 includes a first proximal region 934A and a second proximal region 934B, which are collectively referred to herein as the proximal region 934. The proximal, middle, and distal regions 934, 932, 930, respectively, are clearly shown on FIG. 9. In an embodiment, the proximal region934 extends between 30-60% of the total length of the intermediate portion 922, the middle region 932 extends between 5-20% of the total length of the intermediate portion 922, and the distal region extends between 30-60% of the total length of the intermediate portion 922. In another embodiment, the proximal region 934 extends between 40-50% of the total length of the intermediate portion 922, the middle region 932 extends between 5-15% of the total length of the intermediate portion 922, and the distal region extends between 40-50% of the total length of the intermediate portion 922.

[0102] The proximal region 934 of the capsule 912 is the same as the proximal region 134 of the capsule 112, and the distal region 930 of the capsule 912 is the same as the distal region 130 of the capsule 112. In an embodiment, the cut pattern (of the plurality of slots 926) that establishes the plurality of generally circumferentially extending ribs 924 of the first proximal region 934A and the distal region 930 is the same. More particularly, in an embodiment, within each of the first proximal region 934A and the distal region 930, each pair of longitudinally adjacent ribs 924 is separated by a slot 926. As such, within each of the first proximal region 934A and the distal region 930, slots 926 are helically aligned but are separated from one another. Each slot 926 of the plurality of slots 926 defined within each of the first proximal region 934A and the distal region 930 is circumferentially discontinuous and extends less than 180 degrees around the tubular body 914 such that a pair of longitudinal spines 928 are formed on the tubular body 914 circumferentially opposing one another. In an embodiment, each slot 926 of the plurality of slots 926 defined within each of the first proximal region 934A and the distal region 930 extends between 160 degrees and 198 degrees around the tubular body 914. The two longitudinal spines 928 are formed circumferentially opposing one another (it being understood that only one of the spines 928 is visible within each of the first proximal region 934A and the distal region 930 on FIG. 9). Within each of the first proximal region 934A and the distal region 930, the spines 928 generally connect or maintain adjacent ribs 924 relative to one another, yet permit transverse articulation so that the capsule 912 is bendable around the anatomy in situ. While being flexible for requisite bending or articulation (due to a material strength, thickness, and circumferential width), the spines 928 in combination with the ribs 924 provide an enhanced hoop strength attribute to the intermediate portion 922, to constrain the prosthesis 101 in the collapsed arrangement as well as longitudinal or axial stability for distally advancing the capsule 912 over apartially deployed (and radially expanded) prosthesis 101. With these and other embodiments, the capsule 912 can be configured to readily identify a location of the spines 928 to a user.

[0103] Within the second proximal region 934B, each pair of longitudinally adjacent ribs 924 is separated by a slot 926. As such, the second proximal region 934B, slots 926 are helically aligned but are separated from one another. Each slot 926 of the plurality of slots 926 defined within each of the second proximal region 934B is circumferentially discontinuous and extends less than 180 degrees around the tubular body 914. In an embodiment, each slot 926 of the plurality of slots 926 defined within the second proximal region 934B extends between 160 degrees and 198 degrees around the tubular body 914. However, unlike the first proximal region 934A, each slot 926 within the proximal region 934B is circumferentially offset by approximately ninety degrees from a longitudinally-adjacent slot. As such, along the second proximal region 934B, a total of four discontinuous spines 928B are formed on the tubular body 914 at circumferentially spaced apart locations, i.e., approximately ninety degrees from each other (it being understood that only two of the discontinuous spines 928B are visible within the second proximal region 934B on FIG. 9). Within second proximal region 934B, the discontinuous spines 928B generally connect or maintain adjacent ribs 924 relative to one another, yet permit transverse articulation so that the capsule 912 is bendable around the anatomy in situ. Due to the nature of the discontinuous spines, the second proximal region 934B has a higher flexibility than the first proximal and distal regions 934A, 930, respectively, yet maintains a high degree of longitudinal or axial stability.

[0104] Although depicted with first and second proximal regions 934 A, 934B, the proximal region 932 may be formed with the same cut pattern along its length. Stated another way, in an embodiment, the full length of the proximal region 932 may have the cut pattern of the first proximal region 934A. In another embodiment, the full length of the proximal region 932 may have the cut pattern of the second proximal region 934B.

[0105] In the embodiment of FIGS. 9-10C, the middle region 932 includes a singular circumferentially continuous slot 990 that extends the entire length of the middle region 932 as well as a plurality of circumferentially discontinuous slots 994 that collectively extend the length of the middle region 932. FIG. 10A is an illustrative view of the cut pattern of the capsule 912; FIG. 10B is an enlarged view of the middle region 932 of the cut pattern of the capsule 912; and FIG. 10C is a schematic illustration of the singular circumferentially continuous slot 990 and the plurality of circumferentially discontinuous slots 994. The singular circumferentially continuousslot 990 extends more than 360 degrees around the tubular body 914 such that the singular circumferentially continuous slot 990 has a spiral configuration with a plurality of windings 992. Each winding 992 of the singular circumferentially continuous slot 990 may be considered a single 360 degree revolution of the singular circumferentially continuous slot. In an embodiment, the singular circumferentially continuous slot 990 includes between 5 and 10 windings 992. The windings 992 of the singular circumferentially continuous slot 990 are helically aligned and are continuous with each other (i.e., are not separated from one another).

[0106] In addition to the singular circumferentially continuous slot 990, the middle region 932 also includes the plurality of circumferentially discontinuous slots 994. In an embodiment, the middle region 932 includes a total of between 5 and 10 circumferentially discontinuous slots 994. The circumferentially discontinuous slots 994 are helically aligned and are discontinuous with each other (i.e., are separated from one another). Each circumferentially discontinuous slot 994 of the plurality of circumferentially discontinuous slots 994 extends less than 360 degrees around the tubular body 914. In an embodiment, each circumferentially discontinuous slot 994 of the plurality of circumferentially discontinuous slots 994 extends between 350 degrees and 359 degrees around the tubular body 914. Each circumferentially discontinuous slot 994 of the plurality of circumferentially discontinuous slots 994 defined within the middle region 932 is disposed between a pair of windings 992 formed by the spiral configuration of the singular circumferentially continuous slot 990, and each winding 992 of the singular circumferentially continuous slot 990 is disposed between two longitudinally adjacent circumferentially discontinuous slots 994. Stated another way, the windings of singular circumferentially continuous slot 990 are disposed in an alternating manner with the plurality of circumferentially discontinuous slots 994.

[0107] Each circumferentially discontinuous slot 994 has a first end 996 and an opposing second end 998, and a discontinuity or gap G extends between the first and second ends 996, 998 thereof. The series of discontinuities or gaps G of the plurality of circumferentially discontinuous slots 994 form a singular discontinuous longitudinal spine 929 along the middle region 932. Thus, in this embodiment, a pair of circumferentially opposed continuous longitudinal spines 928 are formed on each of the first proximal and distal regions 934 A, 930, respectively, a total of four discontinuous and circumferentially spaced apart spines 928B are formed on the second proximal region 934B, and a singular discontinuous longitudinal spine 929 is formed on the middle region 932. Due to the singular discontinuous longitudinal spine as compared to the pair ofcircumferentially opposed continuous spines, or as compared to the four discontinuous and circumferentially spaced apart spines, the middle region 932 has a higher flexibility than the proximal and distal regions 934, 930, respectively. The higher flexibility of the middle region 932 permits greater transverse articulation of the capsule 912 along the middle region 932 thereof. The higher flexibility of the middle region 932 results in the capsule 912 having increased bendability and trackability as compared to a capsule in which the middle region 932 has the same or similar cut pattern as the proximal and distal regions 934, 930, respectively.

[0108] The middle region 932 is configured to overlap, overlay, cover or otherwise be disposed over a most flexible portion of the prosthesis 101, for example, a portion of higher flexibility than adjacent portions or a portion having the greatest flexibility of the prosthesis 101. In one embodiment, the flexible (e.g., most flexible) portion may be a portion including the commissure attachment points (e.g., commissure posts or pads). In another embodiment, the flexible portion may be a portion with the lowest density of frame struts (e.g., by cross-sectional number or area). In another embodiment, the flexible portion may be a portion wherein struts of the prosthesis are substantially parallel to the longitudinal axis of the prosthesis (e.g., within 10 degrees or within 5 degrees of parallel). In one embodiment, with respect to the prosthesis 101, the flexible portion may comprise or consist of the portion of prosthesis 101 having the axial struts 384. More particularly, when the prosthesis 101 is disposed within the capsule 912 during delivery, the middle region 932 is longitudinally aligned with the axial struts 384 of the prosthesis 101. When being tracked through a curved region within the vasculature, the axial struts 384 function as a hinge of the frame 360 of the prosthesis. With the highly flexible middle region 932 of the capsule 912 disposed over this hinge, the capsule 912 and the frame 360 are particularly configured to bend along the middle region 932 as needed to conform to the curved region within the vasculature. With respect to the prosthesis 301H, the flexible portion may comprise or consist of the portion including the access cells 366H. By overlapping or overlaying the middle region 932 of the capsule 112 with the portion including the access cells 366H, the delivery device 100 is particularly configured to curve or bend when being tracked through a curved region within the vasculature.

[0109] While the middle region 932 has a higher flexibility than the proximal and distal regions 934, 930, respectively, the middle region 932 of the capsule 912 has a higher hoop strength and axial stability than the middle region 732 of the capsule 112 due to the presence of only a singular circumferentially continuous slot 990 as opposed to two circumferentially continuous slots 790A,790B, and further due to the presence of the singular discontinuous longitudinal spine 929. Thus, the cut pattern of the embodiment of FIGS. 9-10C may be advantageous if it is desired to increase bendability and trackability while still maintaining a high level of axial stability.

[0110] Turning now to FIGS. 11, 12A, 12B, and 12C, a capsule 1112 according to an alternative embodiment is shown. The capsule 1112 may be utilized as the capsule of delivery device 100. The capsule 1112 is similar to the capsule 112 except for the differences described herein. An intermediate portion 1122 of a tubular body 1114 of the capsule 1112 is longitudinally disposed between a proximal end 1118 of the capsule 1112 and a distal end 1120 of the capsule 1112. In general terms, the intermediate portion 1122 incorporates features that impart circumferential or radial rigidity, yet permit or promote transverse articulation, designed to give the capsule 1112 adequate axial and radial strength to prevent buckling or kinking. As described herein, in embodiments hereof, the intermediate portion 1122 of the tubular body 1114 incorporates features that impart circumferential or radial rigidity, yet permit or promote transverse articulation, designed to give the capsule 1112 adequate axial and radial strength to prevent buckling or kinking when being bent or curved as the capsule 1112 is being advanced in situ through the vasculature. The capsule 1112 includes, along the intermediate portion 1122, a cut pattern (by a plurality of slots 1126) that establishes a plurality of generally circumferentially extending ribs 1124. The cut pattern of the capsule 1112 results in reduced bending stiffness of the capsule while maintaining column stiffness.

[0111] The cut pattern of the intermediate portion 1122 may be considered to include three integral sections or regions including a proximal region 1134, a distal region 1130, and a middle region 1132 extending between the proximal region 1134 and the distal region 1130. The proximal region 1134 includes a first proximal region 1134A and a second proximal region 1134B, which are collectively referred to herein as the proximal region 1134. The proximal, middle, and distal regions 1134, 1132, 1130, respectively, are clearly shown on FIG. 11. In an embodiment, the proximal region 1134 extends between 30-60% of the total length of the intermediate portion 1122, the middle region 1132 extends between 5-20% of the total length of the intermediate portion 1122, and the distal region extends between 30-60% of the total length of the intermediate portion 1122. In another embodiment, the proximal region 1134 extends between 40-50% of the total length of the intermediate portion 1122, the middle region 1132 extends between 5-15% of thetotal length of the intermediate portion 1 122, and the distal region extends between 40-50% of the total length of the intermediate portion 1122.

[0112] The proximal region 1134 of the capsule 1112 is the same as the proximal region 134 of the capsule 112, and the distal region 1130 of the capsule 1112 is the same as the distal region 130 of the capsule 112. In an embodiment, the cut pattern (of the plurality of slots 1126) that establishes the plurality of generally circumferentially extending ribs 1124 of the first proximal region 1134A and the distal region 1130 is the same. More particularly, in an embodiment, within each of the first proximal region 1134A and the distal region 1130, each pair of longitudinally adjacent ribs 1124 is separated by a slot 1126. As such, within each of the first proximal region 1134A and the distal region 1130, slots 1126 are helically aligned but are separated from one another. Each slot 1126 of the plurality of slots 1126 defined within each of the first proximal region 1134A and the distal region 1130 is circumferentially discontinuous and extends less than 180 degrees around the tubular body 1114 such that a pair of longitudinal spines 1128 are formed on the tubular body 1114 circumferentially opposing one another. In an embodiment, each slot 1126 of the plurality of slots 1126 defined within each of the first proximal region 1134A and the distal region 1130 extends between 160 degrees and 1118 degrees around the tubular body 1114. The two longitudinal spines 1128 are formed circumferentially opposing one another (it being understood that only one of the spines 1128 is visible within each of the first proximal region 1134A and the distal region 1130 on FIG. 11). Within each of the first proximal region 1134A and the distal region 1130, the spines 1128 generally connect or maintain adjacent ribs 1124 relative to one another, yet permit transverse articulation so that the capsule 1112 is bendable around the anatomy in situ. While being flexible for requisite bending or articulation (due to a material strength, thickness, and circumferential width), the spines 1128 in combination with the ribs 1124 provide an enhanced hoop strength attribute to the intermediate portion 1122, to constrain the prosthesis 101 in the collapsed arrangement as well as longitudinal or axial stability for distally advancing the capsule 1112 over a partially deployed (and radially expanded) prosthesis 101. With these and other embodiments, the capsule 1112 can be configured to readily identify a location of the spines 1128 to a user.

[0113] Within the second proximal region 1134B, each pair of longitudinally adjacent ribs 1124 is separated by a slot 1126. As such, the second proximal region 1134B, slots 1126 are helically aligned but are separated from one another. Each slot 1126 of the plurality of slots 1126defined within each of the second proximal region 1 134B is circumferentially discontinuous and extends less than 180 degrees around the tubular body 1114. In an embodiment, each slot 1126 of the plurality of slots 1126 defined within the second proximal region 1134B extends between 160 degrees and 1118 degrees around the tubular body 1114. However, unlike the first proximal region 1134A, each slot 1126 within the proximal region 1134B is circumferentially offset by approximately ninety degrees from a longitudinally-adjacent slot. As such, along the second proximal region 1134B, a total of four discontinuous spines 1128B are formed on the tubular body 1114 at circumferentially spaced apart locations, i.e., approximately ninety degrees from each other (it being understood that only two of the discontinuous spines 1128B are visible within the second proximal region 1134B on FIG. 11). Within second proximal region 1134B, the discontinuous spines 1128B generally connect or maintain adjacent ribs 1124 relative to one another, yet permit transverse articulation so that the capsule 1112 is bendable around the anatomy in situ. Due to the nature of the discontinuous spines, the second proximal region 1134B has a higher flexibility than the first proximal and distal regions 1134A, 1130, respectively, yet maintains a high degree of longitudinal or axial stability.

[0114] Although depicted with first and second proximal regions 1134A, 1134B, the proximal region 1132 may be formed with the same cut pattern along its length. Stated another way, in an embodiment, the full length of the proximal region 1132 may have the cut pattern of the first proximal region 1134A. In another embodiment, the full length of the proximal region 1132 may have the cut pattern of the second proximal region 1134B.

[0115] In the embodiment of FIGS. 11-12C, the middle region 1132 includes a plurality of circumferentially discontinuous slots 1194 that collectively extend the length of the middle region 1132. FIG. 12A is an illustrative view of the cut pattern of the capsule 1112; FIG. 12B is an enlarged view of the middle region 1132 of the cut pattern of the capsule 1112; and FIG. 12C is a schematic illustration of the plurality of circumferentially discontinuous slots 1194. In an embodiment, the middle region 1132 includes a total of between 10 and 20 circumferentially discontinuous slots 1194. The circumferentially discontinuous slots 1194 are helically aligned and are discontinuous with each other (i.e., are separated from one another). Each circumferentially discontinuous slot 1194 extends less than 360 degrees around the tubular body 1114. In an embodiment, each circumferentially discontinuous slot 1194 extends between 350 degrees and 359 degrees around the tubular body 1114. Each circumferentially discontinuous slot 1194 has afirst end 1196 and an opposing second end 1 198, and a discontinuity or gap G extends between the first and second ends 1196, 1198 thereof.

[0116] The circumferentially discontinuous slots 1194 may be considered to include a first set of slots 1194A and a second set of slots 1194B. The first set of slots 1194A and the second set of slots 1194B are disposed in an interwoven or interleaved manner such that the slots thereof alternate with one another, with each slot 1194A of the first set of slots 1194A being disposed between a pair of longitudinally adjacent slots 1194B of the second set of slots 1194B and each slot 1194B of the second set of slots 1194B being disposed between a pair of longitudinally adjacent slots 1194A of the first set of slots 1194 A. The discontinuity or gap G of each slot 1194A of the first set of slots 1194A is disposed on a first side of the tubular body 1114, and the discontinuity or gap G of each slot 1194B of the second set of slots 1194B is disposed on a second side of the tubular body 1114, with the second side being circumferentially opposed to the first side. Thus, the discontinuities or gaps of the first set of slots 1194A are circumferentially opposed to the discontinuities or gaps of the second set of slots 1194B.

[0117] The series of discontinuities or gaps G of each of the first and second sets of slots 1194A, 1194B form a pair of discontinuous longitudinal spines 1129 along the middle region 1132 (it being understood that only one of the spines 1129 is visible within the middle region 1132 on FIG. 11). Thus, in this embodiment, a pair of continuous longitudinal spines 1128 are formed on each of the first proximal and distal regions 1134A, 1130, respectively, a total of four discontinuous and circumferentially spaced apart spines 1128B are formed on the second proximal region 1134B, and a pair of discontinuous longitudinal spines 1129 are formed on the middle region 1132. Due to the discontinuous longitudinal spines as compared to the continuous spines, or as compared to the four discontinuous and circumferentially spaced apart spines, the middle region 1132 has a higher flexibility than the proximal and distal regions 1134, 1130, respectively. The higher flexibility of the middle region 1132 permits greater transverse articulation of the capsule 1112 along the middle region 1132 thereof. The higher flexibility of the middle region 1132 results in the capsule 1112 having increased bendability and trackability as compared to a capsule in which the middle region 1132 has the same or similar cut pattern as the proximal and distal regions 1134, 1130, respectively.

[0118] The middle region 1132 is configured to overlap, overlay, cover or otherwise be disposed over a most flexible portion of the prosthesis 101, for example, a portion of higherflexibility than adjacent portions or a portion having the greatest flexibility of the prosthesis 101 . In one embodiment, the flexible (e.g., most flexible) portion may be a portion including the commissure attachment points (e.g., commissure posts or pads). In another embodiment, the flexible portion may be a portion with the lowest density of frame struts (e.g., by cross-sectional number or area). In another embodiment, the flexible portion may be a portion wherein struts of the prosthesis are substantially parallel to the longitudinal axis of the prosthesis (e.g., within 10 degrees or within 5 degrees of parallel). In one embodiment, with respect to the prosthesis 101, the flexible portion may comprise or consist of the portion of prosthesis 101 having the axial struts 384. More particularly, when the prosthesis 101 is disposed within the capsule 1112 during delivery, the middle region 1132 is longitudinally aligned with the axial struts 384 of the prosthesis 101. When being tracked through a curved region within the vasculature, the axial struts 384 function as a hinge of the frame 360 of the prosthesis. With the highly flexible middle region 1132 of the capsule 1112 disposed over this hinge, the capsule 1112 and the frame 360 are particularly configured to bend along the middle region 1132 as needed to conform to the curved region within the vasculature. With respect to the prosthesis 301H, the flexible portion may comprise or consist of the portion including the access cells 366H. By overlapping or overlaying the middle region 1132 of the capsule 112 with the portion including the access cells 366H, the delivery device 100 is particularly configured to curve or bend when being tracked through a curved region within the vasculature.

[0119] While the middle region 1132 has a higher flexibility than the proximal and distal regions 1134, 1130, respectively, the middle region 1132 of the capsule 1112 has a higher hoop strength and axial stability than each of the middle regions 732, 932 of the capsules 112, 912, respectively, since the middle region 1132 does not include any circumferentially continuous slots and further includes a pair of circumferentially opposed discontinuous longitudinal spines. Thus, the cut pattern of the embodiment of FIGS. 11-12C may be advantageous if it is desired to increase bendability and trackability while still maintaining a high level of axial stability.

[0120] FIG. 13 is a side view of a distal portion of the delivery device 100 being advanced in situ to a native aortic valve. The delivery device 100 is configured for endoiuminal transcatheter repair / replacement of a defective heart valve, and in particular is configured for a TAVI or transcatheter aortic valve implantation procedure. The delivery device 100 is depicted in a delivery configuration with the prosthesis 101 loaded within the capsule 112, which is configured tohold the prosthesis 101 in a compressed, delivery configuration as shown in FIG. 7 Although FIG. 13 is described with the delivery device 100 including the capsule 112, the delivery device 100 may alternatively include the capsule 912 or the capsule 1112. In the delivery configuration, the capsule 112 is disposed over the prosthesis 101 to compressively retain the prosthesis in engagement with inner shaft 146. The middle region 732 overlaps, overlays, covers or otherwise is disposed over a most flexible portion of the prosthesis 101, for example, a portion of higher flexibility than adjacent portions or a portion having the greatest flexibility of the prosthesis 101. In one embodiment, the flexible (e.g., most flexible) portion may be a portion including the commissure attachment points (e.g., commissure posts or pads). In another embodiment, the flexible portion may be a portion with the lowest density of frame struts (e.g., by cross-sectional number or area). In another embodiment, the flexible portion may be a portion wherein struts of the prosthesis are substantially parallel to the longitudinal axis of the prosthesis (e.g., within 10 degrees or within 5 degrees of parallel). In one embodiment, the flexible portion may comprise or consist of portion of prosthesis 101 having the axial struts 384. More particularly, in FIG. 7, the middle region 732 is longitudinally aligned with the axial struts 384 of the prosthesis 101. When being tracked through a curved region within the vasculature, the axial struts 384 function as a hinge of the frame 360 of the prosthesis. With the highly flexible middle region 732 of the capsule 112 disposed over this hinge, the capsule 112 and the frame 360 are particularly configured to bend as needed along the middle region 732 to conform to the curved region within the vasculature. For example, as shown in FIG. 13, the delivery device 100 is manipulated to advance the compressed prosthesis 101 toward the implantation target site in a retrograde manner through a cut-down to the femoral artery, into the patient's descending aorta. The delivery device 100 is shown after being advanced, under fluoroscopic guidance, over the aortic arch and into the ascending aorta. As the delivery device 100 is advanced over the aortic arch, the capsule 112 bends along the middle region 732 to steer the delivery device 100 over the aortic arch.

[0121] While only some embodiments according to the present invention have been described herein, it should be understood that they have been presented by way of illustration and example only, and not limitation. Various changes in form and detail can be made therein without departing from the spirit and scope of the invention. Further, each feature of each embodiment discussed herein, and of each reference cited herein, can be used in combination with the features of anyother embodiment. All patents and publications discussed herein are incorporated by reference herein in their entirety.

Claims

CLAIMSWhat is claimed is:

1. A delivery device comprising: a handle; a sheath distally extending from the handle, the sheath defining a central lumen therethrough; and a capsule distally extending from the sheath, the capsule having a tubular body with an intermediate portion having a plurality of ribs and a plurality of slots defined therein, with longitudinally adjacent ribs of the plurality of ribs being separated by a slot of the plurality of slots, wherein the plurality of ribs and the plurality of slots substantially extend in a circumferential direction around a longitudinal axis of the capsule, wherein the intermediate portion of the tubular body includes a proximal region, a distal region, and a middle region extending between the proximal region and the distal region, and wherein each slot of the plurality of slots defined within each of the proximal and distal regions is circumferentially discontinuous and extends less than 180 degrees around the tubular body, and wherein at least one slot of the plurality of slots defined within the middle region is a circumferentially continuous slot that extends more than 360 degrees around the tubular body, such that the circumferentially continuous slot has a spiral configuration with a plurality of windings.

2. The delivery device of claim 1, wherein a pair of circumferentially opposing continuous longitudinal spines are formed on the tubular body along the distal region and along at least a portion of the proximal region.

3. The delivery device according to any one of the preceding claims, wherein the proximal region extends between 40-50% of a total length of the intermediate portion, the middle region extends between 5-15% of the total length of the intermediate portion, and the distal region extends between 40-50% of the total length of the intermediate portion.

4. The delivery device according to any one of the preceding claims, wherein the circumferentially continuous slot is singular and the middle region also includes a plurality of circumferentially discontinuous slots which each extend between 350 and 359 degrees around the tubular body.

5. The delivery device of claim 4, wherein each circumferentially discontinuous slot of the plurality of circumferentially discontinuous slots of the middle region is disposed between a pair of longitudinally adjacent windings of the singular circumferentially continuous slot.

6. The delivery device according to any one of the preceding claims, wherein the circumferentially continuous slot includes a first circumferentially continuous slot and a second circumferentially continuous slot, wherein each of the first circumferentially continuous slot and the second circumferentially continuous slot extends more than 360 degrees around the tubular body and has a spiral configuration with a plurality of windings.

7. The delivery device of claim 6, wherein each winding of the first circumferentially continuous slot is disposed between a pair of longitudinally adjacent windings of the second circumferentially continuous slot.

8. The delivery device according to any one of the preceding claims, wherein the capsule of the sheath is configured to retain a prosthesis in a radially compressed state therein.

9. A delivery system for transcatheter delivery of a prosthesis comprising: a delivery device including a handle; a sheath distally extending from the handle, the sheath defining a central lumen there-through; and a capsule distally extending from the sheath, the capsule having a tubular body with an intermediate portion having a plurality of ribs and a plurality of slots defined therein, with longitudinally adjacent ribs of the plurality of ribs being separated by a slot of the plurality of slots,wherein the plurality of ribs and the plurality of slots substantially extend in a circumferential direction around a longitudinal axis of the capsule, wherein the intermediate portion of the tubular body includes a proximal region, a distal region, and a middle region extending between the proximal region and the distal region, and wherein each slot of the plurality of slots defined within each of the proximal and distal regions is circumferentially discontinuous and extends less than 180 degrees around the tubular body, and wherein at least one slot of the plurality of slots defined within the middle region is a circumferentially continuous slot that extends more than 360 degrees around the tubular body, such that the circumferentially continuous slot has a spiral configuration with a plurality of windings; and a prosthesis disposed within the capsule of the sheath in a radially compressed delivery state and configured to deploy to an expanded state after release from the capsule of the sheath, the prosthesis including a most flexible portion, wherein the middle region of the intermediate portion of the tubular body of the capsule is disposed over the most flexible portion of the prosthesis in the radially compressed delivery state.

10. The delivery system of claim 9, wherein a pair of circumferentially opposing continuous longitudinal spines are formed on the tubular body along the distal region and along at least a portion of the proximal region.

11. The delivery system according to any one claims 9-10, wherein the proximal region extends between 40-50% of a total length of the intermediate portion, the middle region extends between 5-15% of the total length of the intermediate portion, and the distal region extends between 40-50% of the total length of the intermediate portion.

12. The delivery system according to any one claims 9-11, wherein the circumferentially continuous slot is singular and the middle region also includes a plurality of circumferentially discontinuous slots which each extend between 350 and 359 degrees around the tubular body, and wherein each circumferentially discontinuous slot of the plurality of circumferentially discontinuous slots of the middle region is disposed between a pair of longitudinally adjacent windings of the singular circumferentially continuous slot.

13. The delivery system according to any one claims 9-12, wherein the circumferentially continuous slot includes a first circumferentially continuous slot and a second circumferentially continuous slot, each of the first circumferentially continuous slot and the second circumferentially continuous slot extending more than 360 degrees around the tubular body and having a spiral configuration with a plurality of windings, and wherein each winding of the first circumferentially continuous slot is disposed between a pair of longitudinally adjacent windings of the second circumferentially continuous slot.

14. The delivery system according to any one claims 9-13, wherein the prosthesis is a prosthetic heart valve including a plurality of axial struts, the plurality of axial struts being the most flexible portion, and wherein at least two of the axial struts of the plurality of axial struts are commissure posts.

15. A method of delivering and deploying a prosthesis at a treatment site, the method comprising the steps of: introducing a delivery system into the vasculature of a patient, the delivery system comprising a delivery device and a prosthesis, the delivery device including a handle; a sheath distally extending from the handle, the sheath defining a central lumen there-through; and a capsule distally extending from the sheath, the capsule having a tubular body with an intermediate portion having a plurality of ribs and a plurality of slots defined therein, with longitudinally adjacent ribs of the plurality of ribs being separated by a slot of the plurality of slots, wherein the plurality of ribs and the plurality of slots substantially extend in a circumferential direction around a longitudinal axis of the capsule, wherein the intermediate portion of the tubular body includes a proximal region, a distal region, and a middle region extending between the proximal region and the distal region, and wherein each slot of the plurality of slots defined within each of the proximal and distal regions is circumferentially discontinuous and extends less than 180 degrees around the tubular body, and wherein at least one slot of the plurality of slots defined within the middle region is a circumferentially continuous slot that extends more than 360 degrees around the tubular body, such that the circumferentially continuous slot has a spiral configuration with a plurality of windings, wherein the prosthesis is disposed within the capsule of the sheath in a radially compressed delivery state, the prosthesis including a most flexible portion, wherein the middleregion of the intermediate portion of the tubular body of the capsule is disposed over the most flexible portion in the radially compressed delivery state; and advancing the delivery system through a curved region within the vasculature, wherein the middle region of the intermediate portion of the tubular body of the capsule bends to conform to the curved region within the vasculature.

16. The method of claim 15, wherein the prosthesis is a prosthetic heart valve including a plurality of axial struts, the plurality of axial struts being the most flexible portion, and wherein at least two of the axial struts of the plurality of axial struts are commissure posts.

17. A delivery device comprising: a handle; a sheath distally extending from the handle, the sheath defining a central lumen therethrough; and a capsule distally extending from the sheath, the capsule having a tubular body with an intermediate portion having a plurality of ribs and a plurality of slots defined therein, with longitudinally adjacent ribs of the plurality of ribs being separated by a slot of the plurality of slots, wherein the plurality of ribs and the plurality of slots substantially extend in a circumferential direction around a longitudinal axis of the capsule, wherein the intermediate portion of the tubular body includes a proximal region, a distal region, and a middle region extending between the proximal region and the distal region, and wherein each slot of the plurality of slots defined within each of the proximal and distal regions is circumferentially discontinuous and extends less than 180 degrees around the tubular body, and wherein each slot of the plurality of slots defined within the middle region is circumferentially discontinuous and extends between 350 and 359 degrees around the tubular body, and wherein a pair of circumferentially opposing continuous longitudinal spines are formed on the tubular body along the distal region and along at least a portion of the proximal region, and wherein a pair of circumferentially opposing discontinuous longitudinal spines are formed on the tubular body along the middle region.

18. The delivery device of claim 17, wherein the proximal region extends between 40-50% of a total length of the intermediate portion, the middle region extends between 5-15% of the total length of the intermediate portion, and the distal region extends between 40-50% of the total length of the intermediate portion.

19. The delivery device according to any one claims 17-18, wherein each slot of the plurality of slots defined within the middle region has a first end, a second end opposing the first end, and a gap that extends between the first and second ends, and wherein the plurality of slots defined within the middle region include a first set of slots and a second set of slots, a slot of the first set of slots being disposed between a pair of longitudinally adjacent slots of the second set of slots, and wherein gaps of the first set of slots are circumferentially opposed to gaps of the second set of slots.

20. The delivery device according to any one claims 17-19, wherein the capsule of the sheath is configured to retain a prosthesis in a radially compressed state therein.

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