Capsule for delivery apparatus for prosthetic medical device

Abstract

To provide a capsule for a delivery apparatus configured to reduce push forces experienced by a user while advancing the delivery apparatus through a patient's vasculature to a target implantation site for a prosthetic medical device contained within the capsule.SOLUTION: A capsule for a delivery apparatus and associated methods are disclosed. As one example, a capsule can include at least one end portion arranged at a proximal end or distal end of the capsule. The at least one end portion narrows in diameter from a wider outer diameter of a middle portion of the capsule to a narrower outer diameter at an end of the at least one end portion spaced away from the middle portion. The at least one end portion is configured to expand to the wider outer diameter in response to a radially outward pressure from a prosthetic medical device during removal of the prosthetic medical device from the inside of the capsule.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of U.S. Provisional Patent Application No. 63 / 036,377, filed June 8, 2020, which is incorporated herein by reference in its entirety.

[0002] The present disclosure relates to a capsule for a delivery device configured to reduce the push force experienced when advancing a prosthetic medical device, such as a prosthetic heart valve housed in the capsule, through the delivery device to a target implantation site. [Background technology]

[0003] The human heart can suffer from a variety of valvular diseases. These valvular diseases can result in significant cardiac malfunction and ultimately require repair of the native valve or replacement of the native valve with a prosthetic valve. Numerous repair devices (e.g., stents) and prosthetic valves, as well as numerous methods for implanting these devices and valves in humans, are known. Percutaneous and minimally invasive surgical approaches are used in various procedures to deliver prosthetic medical devices to locations within the human body that are not easily accessible by surgery or where non-surgical access is desirable. In one specific example, a prosthetic heart valve can be crimped and mounted on the distal end of a delivery device and advanced through the patient's vasculature (e.g., through the femoral artery and aorta) until it reaches the implantation site within the heart. The prosthetic valve is then expanded to its functional size, for example, by deploying the prosthetic valve from a capsule in the delivery device so that the prosthetic valve can self-expand to its functional size (or expand to its functional size via a mechanical actuation mechanism).

[0004] In some embodiments, an introducer sheath may be inserted into the patient's vasculature to aid in the delivery of a prosthetic heart valve (or other prosthetic medical device, such as a stent) to a target implantation site. For example, a delivery device may be advanced through the sheath and the patient's vasculature (or other natural anatomy) to the target implantation site. The capsule located at the distal end of the delivery device is typically the widest portion (having the largest diameter) of the delivery device. The force experienced by a user while advancing the delivery device through the introducer sheath and the patient's vasculature, due to friction between the outer surface of the capsule and the inner surface of the sheath, for example, may be referred to as the "push-in force." In some embodiments, the push-in force may be greater for longer and larger-diameter capsules. The length and outer diameter of the capsule may be determined by the crimped length and diameter of the prosthetic heart valve (or other prosthetic medical device). It is desirable to reduce the push-in force to allow easier delivery of the delivery device to the target implantation site and reduce the potential for trauma to the patient's natural anatomy. [Prior art documents] [Patent documents]

[0005] [Patent Document 1] US Patent Application Publication No. 2014 / 0343670 [Patent Document 2] US Patent Application Publication No. 2012 / 0123529 [Patent Document 3] US Patent Application Publication No. 2010 / 0036484 [Patent Document 4] US Patent Application Publication No. 2010 / 0049313 [Patent Document 5] US Patent Application Publication No. 2012 / 0239142 [Patent Document 6] US Patent Application Publication No. 2018 / 0153689 [Patent Document 7] US Patent Application Publication No. 2018 / 0344456 [Patent Document 8] US Patent Application Publication No. 2019 / 0060057 [Patent Document 9] International Patent Application No. PCT / US2020 / 057691 [Patent Document 10] International Patent Application No. PCT / US2020 / 063104 [Patent Document 11] International Patent Application No. PCT / US2021 / 022467 Summary of the Invention [Problem to be solved by the invention]

[0006] Therefore, a need exists for a delivery device capsule configured to reduce the pushing force experienced by a user when advancing the delivery device through a patient's vasculature to a target implantation site for a prosthetic medical device contained within the capsule. [Means for solving the problem]

[0007] Described herein are embodiments of a capsule of a delivery device configured to deliver a prosthetic medical device to a target implantation site and to reduce the pushing force experienced during advancement of the delivery device to the target implantation site, as well as related methods for delivering a prosthetic medical device to a target implantation site using such a delivery device and capsule. In some embodiments, the capsule can be configured to have a shorter effective length (e.g., the length of the portion of the capsule that may contact the inner wall of the sheath during advancement through a patient). In some embodiments, the shorter effective length is achieved by configuring the capsule to have one or more tapered ends that can be configured to expand during removal of the prosthetic medical device from the capsule at the target implantation site.

[0008] In one exemplary embodiment, a capsule of a delivery device configured to deliver a prosthetic medical device to a target implantation site includes at least one end portion located at a proximal or distal end of the capsule, the end portion narrowing in diameter from a wider outer diameter at an intermediate portion of the capsule to a narrower outer diameter at an end of the at least one end portion spaced from the intermediate portion of the capsule, wherein the at least one end portion is configured to expand to the wider outer diameter in response to radially outward pressure from the prosthetic medical device during removal of the prosthetic medical device from inside the capsule.

[0009] In another exemplary embodiment, a delivery device includes an outer shaft, a nosecone coupled to a distal end of an inner shaft of the delivery device disposed within at least a portion of the outer shaft, and a capsule coupled to the distal end of the outer shaft proximal to the nosecone and configured to move axially relative to the nosecone, the capsule including a cylindrical intermediate portion having a first outer diameter along its length and end portions configured to move between the first and second configurations, wherein in the first configuration the end portion tapers radially inward from the intermediate portion such that it has a reduced diameter relative to the outer diameter of the intermediate portion, and in the second configuration the end portion is expanded to have an expanded diameter greater than the reduced diameter.

[0010] In one exemplary embodiment, the method includes radially expanding a distal end portion of the capsule from a narrowed configuration in which the outer diameter of the distal end portion is smaller than the outer diameter of an intermediate portion of the capsule to an expanded configuration in which the outer diameter of the distal end portion is equal to or greater than the outer diameter of the intermediate portion in response to and during actuating the capsule of the delivery device axially away from a radially compressed prosthetic medical device disposed on the distal end portion of the delivery device to reveal the radially compressed prosthetic medical device.

[0011] In another exemplary embodiment, a method includes the steps of forming a tapered, narrower diameter portion of the capsule of a delivery device at the distal end portion of the capsule so that the outer diameter of the distal end portion narrows radially inward from a wider intermediate portion of the capsule, the capsule being positioned over the distal end portion of the delivery device and configured to cover and retain a radially compressed prosthetic heart valve therein, and, upon reaching a target implantation site for the prosthetic heart valve, retracting the capsule axially away from the prosthetic heart valve to radially expand the distal end portion so that the outer diameter of the distal end portion is equal to or greater than the diameter of the intermediate portion of the capsule.

[0012] In another exemplary embodiment, a method includes forming a tapered, narrower diameter portion of the capsule at a distal end portion of a delivery device such that the outer diameter of the distal end portion narrows radially inward from a wider intermediate portion of the capsule, the capsule being configured to be disposed over the distal end portion of the delivery device and to cover and retain a radially compressed prosthetic heart valve therein. The distal end portion of the capsule is configured to radially expand in response to radially outward pressure from the prosthetic heart valve during removal of the prosthetic heart valve from inside the capsule such that the outer diameter of the distal end portion along its length is equal to or greater than the diameter of the intermediate portion of the capsule.

[0013] The above and other objects, features, and advantages of the present invention will become more apparent from the following detailed description taken in conjunction with the accompanying drawings. [Additional note 1] A capsule of a delivery device configured to deliver a prosthetic medical device to a target implantation site, A capsule comprising at least one end portion located at a proximal or distal end of the capsule, the end portion narrowing in diameter from a wider outer diameter at an intermediate portion of the capsule to a narrower outer diameter at an end of the at least one end portion spaced apart from the intermediate portion of the capsule, the at least one end portion being configured to expand to the wider outer diameter in response to radially outward pressure from the prosthetic medical device during removal of the prosthetic medical device from inside the capsule. [Additional note 2] 2. The capsule of claim 1, wherein at least one of the end portions is a distal end portion disposed at the distal end of the capsule. [Additional note 3] 2. The capsule of claim 1, wherein at least one of the end portions is a proximal end portion disposed at the proximal end of the capsule. [Additional note 4] 2. The capsule of claim 1, wherein at least one of the end portions is a distal end portion disposed at the distal end of the capsule and further comprises a proximal end portion disposed at the proximal end, the proximal end narrowing in diameter from the wider outer diameter to the narrower outer diameter at its proximal end. [Additional note 5] 5. The capsule of claim 4, wherein only the distal end portion is configured to expand to the wider outer diameter, and the proximal end portion is configured to remain in its narrowed configuration. [Additional note 6] 6. The capsule of any one of clauses 1 to 5, wherein at least one of the end portions comprises a plurality of elongated notches spaced apart from one another around the circumference of the at least one end portion and extending axially from the end of the at least one end portion to a portion of the capsule where the at least one end portion transitions to the intermediate portion of the capsule. [Additional note 7] 7. The capsule of claim 6, wherein at least one of the end portions further comprises a plurality of wings formed by a plurality of the notches, each of the wings being formed between two adjacent ones of the plurality of notches, each of the wings being axially oriented along a central longitudinal axis of the capsule and angled radially inward from a wider proximal end of the wings to a narrower distal end of the wings, the distal ends of the wings forming the end of at least one of the end portions of the capsule spaced from the intermediate portion of the capsule. [Additional note 8] 8. The capsule of claim 6 or 7, wherein each notch includes an elongated end extending from the end of at least one of the end portions to the portion of the capsule where the at least one end portion transitions to the intermediate portion of the capsule, and a spherical end disposed at the portion of the capsule where the at least one end portion transitions to the intermediate portion of the capsule. [Additional note 9] 9. The capsule of any one of clauses 1 to 8, comprising a resilient, self-expanding metallic or polymeric material. [Additional Note 10] 10. The capsule of any one of clauses 1 to 9, wherein the capsule is configured to cover and enclose the prosthetic medical device in a radially compressed configuration, the prosthetic medical device having at least one tapered end configured to be surrounded by at least one of the end portions in the radially compressed configuration. [Additional Note 11] 1. A delivery device comprising: An outer shaft; a nosecone coupled to a distal end of the inner shaft of the delivery device disposed within at least a portion of the outer shaft; a capsule coupled to a distal end of the outer shaft proximal to the nosecone and configured for axial movement relative to the nosecone; wherein the capsule comprises: a cylindrical intermediate portion having a first outer diameter along its length; an end portion configured to transition between a first configuration and a second configuration, wherein in the first configuration the end portion tapers radially inward from the intermediate portion to have a reduced diameter relative to the first outer diameter of the intermediate portion, and in the second configuration the end portion is expanded to have an expanded diameter greater than the reduced diameter; A delivery device comprising: [Additional Note 12] 12. The delivery device of claim 11, wherein the expanded diameter is equal to or greater than the first outer diameter of the intermediate portion. [Additional Note 13] 13. The delivery device of claim 11 or 12, wherein the end portion is a distal end portion of the capsule. [Additional Note 14] 14. The delivery device of claim 13, wherein the distal end portion includes a proximal end portion disposed adjacent to the intermediate portion and having an outer diameter equal to the outer diameter of the intermediate portion, and the distal end portion includes a distal end portion spaced apart from the intermediate portion, the distal end portion having an outer diameter smaller than the outer diameter of the intermediate portion when in the first configuration. [Additional Note 15] 15. The delivery device of claim 14, wherein the distal end of the distal end portion is configured to be positioned within the proximal end of the nose cone in a delivery configuration of the delivery device such that in the first configuration, the capsule covers a radially compressed prosthetic heart valve. [Additional Note 16] 16. The delivery device of any one of clauses 13 to 15, wherein the capsule further comprises a proximal end portion tapering radially inward from the intermediate portion to have a reduced diameter relative to the outer diameter of the intermediate portion, and wherein the proximal end portion remains tapered radially inward from the intermediate portion when the distal end portion is in the second configuration. [Additional Note 17] 17. The delivery device of any one of clauses 11 to 16, wherein the end portion comprises a plurality of elongated notches spaced apart from one another around the circumference of the end portion and extending axially from an end of the end portion spaced apart from the intermediate portion to a transition between the end portion and the intermediate portion of the capsule, and wherein the end portion further comprises a plurality of wings formed by the notches, each of the wings being formed between two adjacent ones of the notches and angling radially inward from a wider proximal end to a narrower distal end when the end portion is in the first configuration, the distal ends of the wings forming the end of the end portion of the capsule. [Additional Note 18] 18. The delivery device of any one of clauses 11 to 17, wherein a length of the portion of the capsule having a diameter equal to or greater than the outer diameter of the intermediate portion of the capsule is longer in the second configuration than in the first configuration. [Additional Note 19] forming a tapered, narrower diameter portion of the capsule at the distal end portion of a delivery device such that the outer diameter of the distal end portion narrows radially inward from a wider intermediate portion of the capsule, the capsule being positioned over the distal end portion of the delivery device and configured to cover and retain a radially compressed prosthetic heart valve therein; Including, wherein the distal end portion of the capsule is configured to radially expand in response to radially outward pressure from the prosthetic heart valve during removal of the prosthetic heart valve from inside the capsule such that an outer diameter of the distal end portion along its length is equal to or greater than a diameter of an intermediate portion of the capsule. [Additional Note 20] 20. The method of claim 19, wherein the step of forming the tapered, narrower diameter portion of the capsule includes moving distal ends of a plurality of vanes forming the distal end portion of the capsule radially inward so that they are positioned proximal to one another to form the narrower diameter portion of the capsule, and wherein each vane of the plurality of vanes is separated from adjacent ones of the plurality of vanes by an axially extending notch in the distal end portion. [Additional Note 21] 21. The method of claim 20, wherein the step of forming the tapered, narrower diameter portion of the capsule further includes narrowing a plurality of notches disposed between and separating the plurality of vanes, each notch of the plurality of notches being disposed between two adjacent vanes of the plurality of vanes, and each notch of the plurality of notches being configured to widen as the distal end portion expands radially. [Additional Note 22] 22. The method of claim 20 or 21, wherein forming the tapered, narrower diameter portion of the capsule comprises radially inwardly compressing the distal ends of the plurality of vanes into a radially compressed configuration and setting the vanes in the radially compressed configuration such that the vanes are maintained in the radially compressed configuration until a radially inward force is applied to the inner surfaces of the plurality of vanes by the prosthetic heart valve. [Additional Note 23] 22. The method of claim 20 or 21, wherein forming the tapered, narrower diameter portion of the capsule includes allowing the distal ends of the plurality of vanes to retract radially inward to an undeformed, resting state, and elastically deforming the plurality of vanes in response to radially inward pressure from the prosthetic heart valve to an expanded state in which the distal ends of the plurality of vanes are spaced further apart from one another around the circumference of the distal end portions. [Additional note 24] 22. The method of claim 20 or 21, wherein the distal end portion comprises an elastomeric material and is configured to elastically deform radially outward in response to the radially outward pressure from the prosthetic heart valve. [Additional note 25] 25. The method of any one of clauses 19 to 24, wherein a proximal end portion of the capsule, located opposite the intermediate portion from the distal end portion of the capsule, tapers radially inward from the intermediate portion and is configured to remain radially inward with respect to the remainder of the capsule, including the intermediate portion and the distal end portion, during radial expansion of the distal end portion. [Brief explanation of the drawings]

[0014] [Figure 1] 1 is a side view of an exemplary embodiment of an implantable prosthetic heart valve that can be loaded into a capsule of a delivery device using a loading device, as disclosed herein. [Figure 2] FIG. 2 is a cross-sectional side view of an exemplary embodiment of a delivery device for delivering a prosthetic heart valve, such as the prosthetic heart valve of FIG. 1, to a target implantation site, the delivery device including a capsule for retaining the prosthetic heart valve therein in a compressed configuration. [Figure 3] 3 is a side view of the distal end portion of the delivery device of FIG. 2 shown with a capsule of the delivery device advanced over a portion of the prosthetic heart valve frame. [Figure 4] FIG. 10 is a cross-sectional side view of an embodiment of a capsule of a delivery device having a longer effective length. [Figure 5] FIG. 1C is a cross-sectional side view of a first embodiment of a capsule of a delivery device having a reduced effective length due to the distal end being configured to have a reduced diameter relative to the remainder of the capsule during advancement of the delivery device to a target implantation site within a patient. [Figure 6]FIG. 10 is a cross-sectional side view of a second embodiment of a capsule of a delivery device having a reduced effective length for distal and proximal ends, both of which are configured to have a reduced diameter relative to the remainder of the capsule during advancement of the delivery device to a target implantation site within a patient. [Figure 7] 6 is a side view of the first embodiment of the capsule of FIG. 5, showing a plurality of notches that form wings that allow the narrowed portion of the capsule to expand during removal of the prosthetic medical device from the capsule. [Figure 8] A side view of a second embodiment of the capsule of Figure 6, showing multiple notches that form wings that allow the narrowed portion at the distal end of the capsule to expand during removal of the prosthetic medical device from the capsule. [Figure 9] 8 is a side view of the first embodiment of the capsule of FIG. 7 showing the expanded distal end of the capsule during removal of the prosthetic medical device from the capsule. [Figure 10] 6 is a cross-sectional side view of the capsule of FIG. 5 including a nosecone positioned adjacent to and at least partially covering the distal end of the capsule. [Figure 11] 1 is a flow diagram of a method for operating a capsule having a reduced effective length of a delivery apparatus configured to deliver a prosthetic medical device to a target implantation site within a patient. DETAILED DESCRIPTION OF THE INVENTION

[0015] General Considerations For purposes of this description, certain aspects, advantages, and novel features of embodiments of the present disclosure are described herein. The described methods, systems, and apparatuses should not be construed as limiting in any way. Instead, the present disclosure is directed to all novel and non-obvious features and aspects of the various disclosed embodiments, alone and in various combinations and subcombinations with each other. The disclosed methods, systems, and apparatuses are not limited to any particular aspect, feature, or combination thereof, nor do they require that any one or more particular advantages be present or problems be solved.

[0016] It should be understood that a feature, integer, property, compound, chemical moiety, or group described in connection with a particular aspect, embodiment, or example of the present disclosure is applicable to any other aspect, embodiment, or example described herein, unless inconsistent. All features and / or all steps of any method or process disclosed in this specification (including the accompanying claims, abstract, and drawings) may be combined in any combination, except for combinations in which at least some of such features and / or steps are mutually inconsistent. The present disclosure is not limited to the details of any of the foregoing embodiments. The present disclosure extends to any novel feature or any novel combination of features disclosed in this specification (including the accompanying claims, abstract, and drawings), or any novel step or any novel combination of steps of any method or process so disclosed.

[0017] While the operations of some of the disclosed methods are described in a particular chronological order for convenient presentation, it should be understood that this description style encompasses rearrangements unless a specific ordering is required by specific terminology set forth below. For example, operations described chronologically may, in some cases, be rearranged or performed simultaneously. Moreover, for the sake of brevity, the accompanying figures may not show the various ways in which the disclosed methods, systems, and apparatuses can be used in conjunction with other systems, methods, and apparatuses.

[0018] As used herein, the terms "a," "an," and "at least one" include one or more of the specified elements. That is, where there are two of a particular element, one of those elements is also present, and thus there is "an" element. The terms "a plurality of" and "plural" mean two or more of the specified elements.

[0019] As used herein, the term "and / or" used between the last two of a list of elements means any one or more of the listed elements. For example, the phrase "A, B, and / or C" means "A," "B," "C," "A and B," "A and C," "B and C," or "A, B, and C."

[0020] As used herein, the term "coupled" generally means physically joined or connected and, unless specifically stated to the contrary, does not exclude the presence of intermediate elements between the joined items.

[0021] Directions and other relative references (e.g., inner, outer, upper, lower, etc.) may be used to facilitate discussion of the principles in the drawings and herein, but are not intended as limiting. For example, several terms such as “inside,” “outside,” “top,” “down,” “interior,” “exterior,” etc. may be used. Such terms are used, where applicable, to provide a degree of descriptive clarity, particularly when dealing with relative relationships with respect to the illustrated embodiments. However, such terms are not intended to imply absolute relationships, positions, and / or orientations. For example, with respect to an object, an “upper” portion can become a “lower” portion simply by flipping the object over. Nevertheless, the portion is still the same portion, and the object remains the same. As used herein, "and / or" means "and" or "or", as well as "and" and "or".

[0022] As used herein, with respect to prosthetic medical devices (e.g., heart valves), capsules, and delivery devices, "proximal" refers to a location, direction, or portion of a component that is closer to the handle of the delivery device, which is external to the user and / or patient, while "distal" refers to a location, direction, or portion of a component that is further away from the user and / or handle of the delivery device and closer to the implantation site. The terms "longitudinal" and "axial," unless expressly defined otherwise, refer to axes extending proximally and distally. Additionally, the term "radial" refers to an axis along a radius from the center of an object and a direction disposed perpendicular to a point (where the axis is positioned at the center, such as the longitudinal axis of a prosthetic valve).

[0023] Examples of the disclosed technology Described herein are examples of capsules for delivery devices having a delivery configuration in which one or more ends of the capsule are narrowed relative to the remainder of the capsule to reduce the outer surface area of ​​the capsule that may contact the inner surface of a sheath through which the delivery device is advanced to reach a target implantation site for a prosthetic medical device radially compressed inside the capsule. Thus, friction between the capsule and the sheath (and / or the patient's natural anatomy) can be reduced, thereby reducing the pushing force experienced by a user advancing the delivery device through a patient. In some embodiments, the narrowed distal end of the capsule can be configured to expand to a wider diameter to enable removal of the prosthetic medical device from the capsule upon reaching the target implantation site.

[0024] In some embodiments, the delivery device is configured to deliver and implant a prosthetic heart valve, such as the exemplary prosthetic heart valve of FIG. 1 , at a selected implantation site within a patient (e.g., within a native aortic, mitral, tricuspid, or pulmonary valve). For example, by retracting the capsule of the delivery device away from the radially compressed prosthetic heart valve, the prosthetic heart valve can expand to its expanded configuration and implant itself at the target implantation site. In other embodiments, upon retraction of the capsule away from the radially compressed prosthetic heart valve, an additional actuator of the delivery device can be actuated to mechanically expand the prosthetic heart valve to its expanded configuration for implantation of the prosthetic heart valve at the target implantation site.

[0025] Figure 1 shows a prosthetic heart valve 10 according to one embodiment that may be implanted using a delivery device such as delivery device 100 of Figure 2 (described further below). In some embodiments, prosthetic heart valve 10 is a self-expanding valve that is delivered via delivery device 100 to the implantation site in a radially compressed state. The prosthetic valve can self-expand radially to its functional size when advanced from a delivery capsule at the distal end of the delivery device (Figure 2).

[0026] The prosthetic heart valve 10 comprises a stent or frame 12 and a valve-like structure 14 (e.g., a cusp or flap valve) supported by the frame 12. The frame 12 may have a plurality of interconnected struts 16 arranged in a lattice-like pattern and forming a plurality of cusps 18 at the inflow end 20 and the outflow end 22 of the frame 12.

[0027] The frame 12 may include a plurality of angularly spaced posts 24 extending from each apex 18 at the outflow end of the frame 12. The frame 12 in the illustrated embodiment includes three such posts 24, although a greater or lesser number may be used. In one implementation, the frame 12 may have posts extending from all of the apexes 18 at the outflow end of the frame. Each post 24 may have an eyelet or opening 26 that can be used to form a releasable connection with the delivery device 100.

[0028] In some embodiments, the frame 12 may not include the posts 24, and the apertures 26 may be formed in the apex 18 at the outflow end of the frame.

[0029] In other embodiments, the openings 26 (whether formed in the posts 24 or the apex 18) may be formed in the inlet (or inflow) end 20 of the frame 12 if other delivery device configurations or other delivery techniques require an opening in the inlet end of the frame, such as a transapical delivery approach.

[0030] In certain embodiments, prosthetic heart valve 10 is a self-expanding heart valve, in which case frame 12 is made of a superelastic, self-expanding material (e.g., a nickel-titanium alloy such as Nitinol) as known in the art. When used with delivery device 100 (FIG. 2), prosthetic valve 10 can self-expand from a radially compressed state to a radially expanded state when advanced from a delivery capsule (e.g., a delivery sheath) of the delivery device.

[0031] In other embodiments, the frame 12 may be made of any of a variety of suitable plastically expandable materials (e.g., stainless steel, cobalt chromium alloy, etc.), and the prosthetic heart valve may be expanded from a radially compressed state to a radially expanded state by actuating other expansion means of the delivery device, such as an inflatable balloon, that causes radial expansion of the prosthetic valve.

[0032] The valve-like structure 14 may include multiple cusps 28. The valve-like structure typically includes three cusps 28 arranged in a tricuspid arrangement, although a greater or lesser number of cusps 28 may be used. The cusps 28 may be made of any of a variety of suitable materials, including natural tissue (e.g., bovine pericardium or pericardium from other sources) or synthetic materials (e.g., polyurethane). Adjacent lateral portions of the outflow edges (top edges in the drawing) of adjacent cusps may be secured to one another to form a valve-like structure coaptation surface 30, which may be secured to a frame with sutures 32.

[0033] The prosthetic valve 10 may further include an inner skirt 34 attached to the inside of the frame 12. The skirt 34 helps establish a seal with surrounding tissue after implantation. The skirt 34 may also be used to attach a portion of the cusp 28 to the frame 12. For example, in the illustrated embodiment, the inflow edges of the cusps (lower edges in the drawing) may be sutured to the skirt 34 along suture line 36. The skirt 34 may be directly connected to the frame 12 by sutures or the like. Although not shown, the prosthetic valve 10 may include an outer skirt attached to the outside of the frame instead of or in addition to the inner skirt 34 to further seal the prosthetic valve to surrounding tissue. The inner and / or outer skirt may be made of any of a variety of suitable materials, including natural tissue (e.g., pericardial tissue), or any of a variety of synthetic materials, which may be woven, nonwoven, braided, knitted, and / or combinations thereof. In one particular embodiment, the inner skirt 34 is made of polyethylene terephthalate (PET) fabric.

[0034] Exemplary configurations of prosthetic heart valves are further disclosed in U.S. Patent Application Publication Nos. 2014 / 0343670, 2012 / 0123529, 2010 / 0036484, and 2010 / 0049313, the disclosures of which are incorporated herein by reference.

[0035] An implantable expandable medical device, such as prosthetic heart valve 10, or another type of prosthetic heart valve (e.g., a mechanically expandable valve), or an expandable stent, may be delivered to the implantation site via a delivery device, one embodiment of which is shown in Figures 2 and 3 as delivery device 100.

[0036] 2 , delivery device 100 may include a handle portion 132 and a first shaft 134 extending distally therefrom. A user, such as a physician or clinician, can operate delivery device 100 via actuation of a number of knobs 136, dials, and / or buttons 138 a, 138 b disposed on handle portion 132. First shaft 134 has a proximal end portion 140 and a distal end portion 142. Proximal end portion 140 of first shaft 134 may be coupled to handle portion 132.

[0037] As shown in FIG. 2 , the delivery device 100 may include a second shaft 152. The second shaft 152 extends distally and coaxially from the handle portion 132 through the first shaft 134. In the illustrated embodiment, the first shaft 134 is the outermost shaft of the delivery device and may therefore be referred to as the outer shaft 134 of the delivery device. In the illustrated embodiment, the second shaft 152 is the innermost shaft of the delivery device and may therefore be referred to as the inner shaft 152 of the delivery device. In some embodiments, the delivery device 100 may include a third shaft, which is an intermediate shaft disposed between the inner shaft 152 and the outer shaft 134.

[0038] A nosecone 144 may be connected or attached to a distal end portion of the inner shaft 152. The nosecone 144 may have a tapered outer surface as shown for atraumatic tracking of the delivery device 100 through the patient's vasculature. The inner shaft 152 extends through the prosthetic valve 10.

[0039] In certain embodiments, the first shaft 134 and the second shaft 152 may be configured to be movable relative to one another, including relative axial movement (in proximal and distal directions) and / or relative rotational movement (in clockwise and counterclockwise directions). A guidewire 154 (as shown in FIG. 3) may extend through a central lumen of the inner shaft 152 and an inner lumen of the nosecone 144 such that the delivery device 100 may be advanced over the guidewire 154 inside the patient's vasculature during delivery of the prosthetic valve 10. The guidewire 154 may be inserted into the inner shaft 152 via a proximal port 155 ( FIG. 2 ) in the handle portion 132.

[0040] A delivery capsule 146 is coupled to the distal end portion 142 of the first shaft 134 proximal to the nosecone 144. The delivery capsule 146 houses the prosthetic valve 10 therein in a radially compressed state, as shown in FIGS. 2-3 . In one embodiment, the delivery capsule 146 covers and retains the underlying compressed prosthetic valve of FIG. 1 . In some embodiments, the delivery device 100 is particularly suited for the delivery and implantation of a self-expanding prosthetic valve 10 that radially expands to its functional size under its own resiliency upon deployment from the delivery capsule 146. The prosthetic valve 10 may be deployed from the capsule 146 by retracting the capsule 146 proximally relative to the prosthetic valve and / or by advancing the prosthetic valve 10 distally relative to the capsule 146 so that the prosthetic valve is advanced out of the open distal end of the capsule. In some embodiments, the capsule 146 can be retracted by rotating the inner torque shaft of the delivery device, which causes axial movement of the capsule 146 relative to the outer shaft 134. In other embodiments, the capsule 146 can be an extension of the outer shaft 134, or can be fixed to the outer shaft 134 such that axial movement (distal or proximal) of the outer shaft causes axial movement of the capsule in the same direction. Further details of delivery devices that can be used to deploy self-expanding prosthetic valves can be found in U.S. Patent Application Publication Nos. 2014 / 0343670, 2012 / 0239142, and 2010 / 0049313, which are incorporated herein by reference.

[0041] In other embodiments, the delivery device 100 can deliver another type of prosthetic heart valve, such as a mechanically expandable heart valve. Various embodiments of mechanically expandable prosthetic heart valves, actuator assemblies, and delivery devices for delivering such mechanically expandable valves can be found in U.S. Patent Application Publication Nos. 2018 / 0153689, 2018 / 0344456, and 2019 / 0060057, and International Patent Applications PCT / US2020 / 057691, PCT / US2020 / 063104, and PCT / US2021 / 022467, which are incorporated by reference herein in their entireties.

[0042] As shown in Figure 2, the delivery capsule 146 is configured to receive the prosthetic heart valve 10, or another type of prosthetic heart valve or implantable medical device, in a radially compressed state for delivery into the patient's vasculature. Figure 3 shows the delivery capsule 146 advanced over a portion of the prosthetic heart valve 10.

[0043] In some embodiments, a valve retention mechanism may be used to form a releasable connection between the prosthetic valve 10 and the delivery device 100. For example, in some embodiments, the posts 24 of the frame 12 may be retained within corresponding recesses in the shaft or retention member of the delivery device, allowing the frame posts to expand out of their corresponding recesses when the capsule 146 is retracted to deploy the prosthetic valve. In other embodiments, multiple suture loops may be connected to the suture retention mechanism of the delivery device and extend through the openings 26 of the posts 24 to form a releasable connection between the prosthetic valve and the delivery device. In other embodiments, the retention mechanism may include inner and outer metal fork members that form a releasable connection between the delivery device and the prosthetic valve. Further details regarding delivery devices including alternative valve retention mechanisms are disclosed in U.S. Patent Application Publication Nos. 2014 / 0343670, 2012 / 0239142, and 2010 / 0049313.

[0044] 4 is a schematic diagram of a first embodiment of a capsule 202 disposed on a distal end portion of an outer shaft 204 of a delivery device 200. In some embodiments, the delivery device 200 can be the same as or similar to the delivery device 100 shown in FIG. 2. Thus, the outer shaft 204 can be similar to the first shaft 134 of the delivery device 100, and the capsule 202 can be similar to the capsule 146 shown in FIG. 2. As described above with reference to FIGS. 2 and 3, the capsule 202 encapsulates a radially compressed (e.g., crimped) prosthetic medical device 206, such as the valve 10 of FIG. 1, another type of prosthetic heart valve (e.g., a mechanically expandable valve), or another type of radially expandable medical device (e.g., a stent).

[0045] The geometry of the capsule 202, including the outer diameter 208 and the length 210, may be determined by the crimp profile of the radially compressed prosthetic medical device 206. For example, as shown in FIG. 4 , the length 210 may correspond to the length of the crimped prosthetic medical device 206 (e.g., may be the same as or longer than the length of the prosthetic medical device 206). Furthermore, the inner diameter 212 of the capsule 202 is defined by the crimped diameter of the radially compressed prosthetic medical device 206. Thus, the outer diameter 208 of the capsule 202 may be selected based on the determined inner diameter 212 and thickness of the capsule 202. The capsule 202 may be comparable to a conventional capsule having a relatively constant outer diameter 208 along its entire length 210.

[0046] During an implantation procedure, a radially compressed prosthetic medical device 206 disposed at the distal end portion of the delivery apparatus 200 is advanced through the patient's vasculature (or other internal lumen) via the delivery apparatus to a target implantation site. In some embodiments, an introducer sheath may be inserted into the patient's vasculature, and the delivery apparatus 200 may be advanced through the sheath and the patient's vasculature to the target implantation site. During delivery of the device 206 to the target implantation site, the capsule 202 may contact (and slide against) the inner wall of the surrounding sheath, resulting in friction between the capsule and the sheath. These frictional forces between the outer wall of the capsule 202 and the inner wall of the sheath may be experienced as a "pushing force" by a user advancing the delivery apparatus. For example, as friction between the capsule 202 and the sheath increases, the pushing force felt by a user pushing the delivery apparatus through the sheath may also increase. In some embodiments, friction and push-in forces may increase as the surface contact area between the outer wall (or surface) of capsule 202 and the inner wall (or surface) of the sheath increases. The surface contact area may be defined by the effective length of capsule 202. As used herein, "effective length" refers to the length of the portion of capsule 202 that may contact the inner wall of the sheath during the implantation procedure. As shown in FIG. 4, the effective length of capsule 202 is equal to the overall length 210 of capsule 202.

[0047] In some embodiments, the crimp profile of the radially compressed prosthetic medical device 206 may not have a constant diameter along its length. For example, the device 206 may have portions at its distal and / or proximal ends that have a smaller diameter than at an intermediate portion of the device when in a radially compressed state and / or taper radially inward from the intermediate portion (e.g., as shown in FIGS. 5 and 6, and as further described below).

[0048] Thus, in these embodiments, the capsule can be allowed to assume a narrowed shape with a smaller diameter around those smaller diameter portions of the device 206 during delivery of the device 206 to the target implantation site. As a result, the effective length of the capsule can be reduced, thereby reducing the surface area of ​​the capsule that can contact the sheath and reducing the push-through force experienced by the user. As a result, the delivery apparatus can be more easily navigated through the patient's vasculature.

[0049] 5-10 illustrate various embodiments of capsules having reduced effective lengths as a result of the proximal and / or distal ends being crimped or configured to a smaller diameter (relative to the remainder or intermediate portion of the capsule) during delivery of a prosthetic medical device disposed within the capsule to its target implantation site. Specifically, FIGS. 5, 7, 9, and 10 illustrate a first embodiment of capsule 220 including a distal end (or distal end portion) configured to be crimped or configured to a smaller diameter configuration than the remainder of capsule 220 for delivery of device 206 to the target implantation site (e.g., during advancement of a delivery apparatus to the target implantation site). FIGS. 6 and 8 illustrate a second embodiment of capsule 250, which may be similar to capsule 220, but in which both its distal and proximal ends are configured to be crimped or configured to a smaller diameter configuration than the remainder of capsule 250 (e.g., intermediate portion) for delivery of device 206 to the target implantation site.

[0050] 5, capsule 220 is shown in a delivery configuration. As used herein, the delivery configuration may be defined as the configuration of capsule 220 during advancement of the distal end portion of delivery apparatus 200 through an introducer sheath and the patient's vasculature (or other internal lumen) to deliver device 206 to a target implantation site (e.g., the patient's heart). In the delivery configuration, device 206 is disposed on the distal end portion of delivery apparatus 200 in its radially compressed configuration, and capsule 220 is disposed on top of (over) radially compressed device 206.

[0051] 5, in some embodiments, the device 206 can have a distal end portion 222 that has a smaller diameter than the remainder of the device 206 when in its radially compressed configuration. For example, as shown in FIG. 5, the distal end portion 222 can taper (or, in other embodiments, step) radially inward from a wider intermediate portion (or remainder) 224 of the device 206. As a result, the distal end of the device 206 has a first diameter 226 that is smaller than a second diameter 228 of the intermediate portion 224. In some cases, the distal end portion 222 can be crimped more than the intermediate portion 224 by virtue of less material (e.g., skirt or peak material) located within the distal end portion, thereby allowing the device 206 to assume a tapered shape along the distal end portion 222.

[0052] Because at least a portion of device 206 (e.g., distal end portion 222) has a smaller diameter than intermediate portion 224 of device 206, capsule 220 need not be perfectly cylindrical and have the same diameter (e.g., outer diameter 208) along the entire length 210 of capsule 220. Instead, as shown in FIG. 5 , distal end portion 230 of capsule 220, which corresponds to and is disposed around distal end portion 222 of device 206, may be narrower than the remainder of capsule 220 when in the delivery configuration.

[0053] For example, as shown in FIG. 5 , distal end portion 230 of capsule 220 tapers from outer diameter 208 to a narrower diameter 232 at its distal end. In other embodiments, the taper of distal end portion 230 of capsule 220 may be more or less pronounced than that shown in FIG. 5 , or the distal end portion may step down to a more constant, smaller diameter based on (e.g., in some embodiments, conforming to) the contour of distal end portion 222 of device 206. As shown in FIG. 5 , distal end portion 230 has a smaller outer diameter than outer diameter 208 of the remainder of capsule 220. As a result, outer surface 234 of capsule 220 in the region of distal end portion 230 may not contact (or at least may have reduced contact with) the inner wall of the introducer sheath and / or the patient's anatomy (e.g., vasculature). Thus, the effective length 236 of capsule 220 is shorter than the overall length 210 of capsule 220 (and the effective length of conventional capsule 202, which may have a relatively constant diameter along its length 210 and be cylindrical in shape). By having a narrower diameter portion (e.g., at its distal end), capsule 220 has a shorter effective length 236 and therefore may experience reduced pushing forces (compared to conventional capsule 202 of FIG. 4 ) when advancing delivery device 200 through a patient's vasculature (and through a sheath).

[0054] In other embodiments, different or additional portions of the capsule may have a reduced diameter relative to the remainder or middle portion of the capsule, thereby reducing the effective length of the capsule. For example, as shown in Figure 6, capsule 250 has both distal end portion 252 and proximal end portion 254 that, when in the delivery configuration, have a smaller outer diameter relative to the remainder or middle portion 256 of capsule 250. This may be made possible by device 206 having both distal and proximal end portions that are tapered or have a reduced diameter compared to the middle portion of device 206.

[0055] 6 , a first outer diameter 258 at a distal end (the end of distal end portion 252) and a second outer diameter 260 at a proximal end (the end of proximal end portion 254) of capsule 250 are each smaller than an outer diameter 208 of an intermediate portion 256 of capsule 250. As a result, capsule 250 has an effective length 262 that is shorter than an overall length 210 of capsule 250. In some embodiments, effective length 262 of capsule 250 is shorter than effective length 236 of capsule 220. As a result, delivery device 200 including capsule 250 may provide a reduced push-through force during delivery of device 206 to a target implantation site compared to a delivery device including capsule 220 ( FIG. 5 ) or capsule 202 ( FIG. 4 ).

[0056] In some embodiments, the amount of taper, minimum outer diameter (e.g., outer diameters 258 and 260), or length of the reduced diameter portion of capsule 250 may be the same or different at distal end portion 252 and proximal end portion 254.

[0057] In other embodiments, a capsule similar to capsule 220 and / or capsule 250 may have a reduced diameter portion only at its proximal end (e.g., only proximal end portion 254 has a reduced diameter relative to outer diameter 208). As described above, the size (e.g., diameter, length, and / or taper angle) of the capsule's reduced diameter portion may be determined by the shape or profile of device 206 in the radially compressed configuration. Thus, if device 206 tapers at both its distal and proximal ends in the radially compressed state, the delivery device capsule may resemble capsule 250 of FIG. 6, which has both tapered proximal and distal end portions. In another example, if device 206 tapers at only one of its ends (e.g., its distal end), the delivery device capsule may resemble capsule 220 of FIG. 5, which has a single tapered end (e.g., distal end portion 230). Additionally, the degree of angulation or amount of narrowing of the distal and / or proximal end portions of the capsule may be selected based on the shape or contour of the corresponding distal and / or proximal end portions of the radially compressed device 206. In this manner, the taper of the reduced diameter portion of the capsule may be adapted to follow the overall contour of the corresponding end portion of the device 206.

[0058] In some embodiments, capsules having an effective length that is shorter than the overall length (e.g., capsule 220 of FIG. 5 and capsule 250 of FIG. 6) can be configured to have a shorter effective length in a delivery configuration with device 206 disposed therein, but to have a wider distal end portion (e.g., a distal end portion having an outer diameter equal to or greater than outer diameter 208) when device 206 is loaded into the capsule and when the device is removed from the capsule (e.g., upon reaching the target implantation site). For example, before device 206 is loaded into the capsule, and after device 206 is revealed at the target implantation site by moving device 206 away from the capsule or retracting the capsule away from device 206, the capsule can assume a configuration similar to capsule 202 of FIG. 4.

[0059] In some embodiments, after device 206 is loaded into the capsule, the distal and / or proximal end portions of the capsule may be crimped, formed, or set into a smaller diameter delivery configuration (e.g., as shown in FIG. 5 or 6). In this manner, the capsule (e.g., capsule 220 or capsule 250) may be configured to have one or more smaller diameter (or tapered) ends in the delivery configuration and to expand to a wider diameter at least at the distal end during insertion and removal of the device into and from the capsule.

[0060] 7 and 8, distal end portion 230 of capsule 220 and distal end portion 252 of capsule 250 may include a plurality of elongated notches (or slots) 270 spaced apart from one another around the circumference of the distal end portion. Each notch 270 may extend from distal end 272 of the capsule to a portion where the distal end portion transitions to the remaining or intermediate portion of the capsule (e.g., having a larger outer diameter 208). The location of the proximal end of notch 270 in this portion of the capsule is labeled 274 in FIGS. 7 and 8.

[0061] In some embodiments, each notch 270 extends through the entire thickness of the capsule.

[0062] The notches 270 form a plurality of wings (or wedges) 276 of the capsule. For example, each wing 276 may be formed between two adjacent notches 270. Each wing 276 may extend from the distal end 272 to a position 274. In this manner, the wings 276 may be axially oriented relative to the central longitudinal axis 268 of the capsule and delivery device 200.

[0063] In some embodiments, the notches 270 may be spaced at regular intervals from one another around the circumference of the capsule. In other embodiments, the notches 270 may be spaced at irregular intervals around the circumference of the capsule. As a result, the vanes 276 may have the same or different sizes based on the spacing of the notches 270.

[0064] 7 and 8, each notch 270 may include an elongated end 271 extending from a distal end 272 to a location 274 and a more bulbous end 273 disposed at (e.g., at its proximal end) location 274. In some embodiments, by having a proximal end that is wider than the elongated end of notch 270, the wings formed by the notch may have improved flexibility (e.g., improved ability to radially expand and / or compress).

[0065] Prior to crimping or placing a capsule (e.g., capsule 220 or capsule 250) into a delivery configuration (as shown in FIGS. 5-8) in which the distal and / or proximal end portions are narrowed relative to the remainder or intermediate portion of the capsule, the distal end portion of the capsule may resemble the capsule in FIG. 4 or 9. In this pre-delivery (and pre-crimping) configuration, wings 276 may be expanded radially outward at distal end 272 such that the diameter of the capsule at distal end 272 is the same as, similar to, or greater than outer diameter 208 of the remainder of the capsule.

[0066] In some embodiments, when a capsule includes a narrowed proximal end, as shown in the capsules of Figures 6 and 8, the proximal end portion 254 may remain in a narrowed configuration before crimping the capsule, after crimping the capsule, and after deploying the prosthetic medical device from the capsule. Thus, in some embodiments, the narrowed proximal end portion 254 may not change shape / diameter because the narrowed shape does not affect the loading or removal of a device into or from the capsule 250. Thus, in some embodiments, only the distal end portion may include the wings 276 and notch 270, and the proximal end portion, even if configured to have a narrowed configuration, does not include the wings and notch (e.g., as shown in the embodiment of Figure 8).

[0067] In other embodiments, the narrowed proximal end may be configured to expand during removal of the device from the capsule.

[0068] After loading a prosthetic medical device (e.g., device 206, which in some embodiments may be a prosthetic heart valve) into a capsule (e.g., capsule 220 or 250), distal end portion 230 of capsule 220 or distal end portion 252 of capsule 250 may be crimped, compressed, or formed into its tapered or small-diameter delivery configuration (as shown in FIGS. 5-8 ). In some embodiments, crimping or compressing the distal end portion into the small-diameter delivery configuration may include forcing wings 276 radially inward toward central longitudinal axis 268 to form a tapered (or sloped or smaller-diameter) profile in distal end portion 230 or 252. Thus, in the delivery configuration, each wings 276 may angle radially inward from a wider proximal end 280 of wings 276 to a narrower distal end 278 of wings 276. The distal ends 278 of the plurality of wings 276 may form the distal end 272 of the capsule.

[0069] In some embodiments, capsule 220 or 250 may comprise a resilient, self-expanding (e.g., shape-memory) metallic or polymeric material (e.g., a nickel-titanium alloy such as Nitinol) as known in the art. For example, notches 270 may be created in distal end portion 230 or 252 of a cylindrical capsule (e.g., in an expanded profile, as shown in FIG. 4 ) to form wings 276. Wings 276 may then be crimped radially inward and shape-set (e.g., via heat treatment or another forming method) into a small-diameter delivery configuration (as shown in FIGS. 5-8 ). Alternatively, capsule 220 or 250 may comprise a plastically deformable material (e.g., stainless steel or a cobalt-chromium alloy), and wings 276 may be plastically deformed by crimping to assume a small-diameter delivery configuration.

[0070] In other embodiments, capsule 220 or 250 may comprise an elastomeric material (e.g., silicone) formed into a conical, tapered, or narrowed shape as shown in any of FIGS. 5-8 . In this embodiment, capsule 220 or 250 may not include notch 270. Alternatively, in some embodiments, elastomeric capsule 220 or 250 may include a groove or indentation, instead of notch 270, that forms a thin portion (e.g., an axially extending narrow groove) in the distal end portion of the capsule, improving the flexibility of the distal end portion of the capsule. In other embodiments, elastomeric capsule 220 or 250 may not include a groove, indentation, or notch; instead, the narrow portion (e.g., distal end portion) of the capsule may be configured to expand radially outward to an expanded configuration. For example, in some embodiments, the distal end portion of the capsule may comprise a thinner elastomeric material than the remainder of the capsule. As will be further described below, when the prosthetic medical device is deployed from the capsule, the elastomeric distal end portion 230 or 252 of the capsule can expand (or stretch) radially outward in response to the force of the prosthetic heart valve sliding axially outward from the distal end 272 of the capsule and through the distal end 272 of the capsule (e.g., as shown in FIG. 9).

[0071] 9, when capsule 220 (or, in other embodiments, capsule 250) is retracted away from device 206 (or device 206 is moved axially outward from the capsule) during the implantation procedure (e.g., after reaching the target implantation site), wings 276 expand radially outward due to the radially outward force of device 206 contacting the inner wall (or inner surface) of wings 276. As a result, wings 276 of distal end portion 230 reopen to the larger outer diameter 208 of the remainder of capsule 220. As shown in FIG. 9, notches 270 widen at their distal ends to accommodate this expansion.

[0072] 10 , capsule 220 (or, in other embodiments, capsule 250) may be disposed adjacent to and partially within the interior of delivery device nosecone 144 when in the delivery configuration. For example, the distal end of narrowed distal tip portion 230 may be inserted into an opening in the nosecone to form a relatively continuous outer surface between nosecone 144 and capsule 220. This configuration may result in a more atraumatic configuration during delivery of the prosthetic medical device to the target implantation site. As a result, degradation of the introducer sheath and / or the patient's anatomy during advancement of the delivery device distal end portion to the target implantation site may be reduced.

[0073] 11 shows a flow diagram of a method 300 for manipulating a capsule of a delivery apparatus configured to deliver a prosthetic medical device (e.g., a prosthetic heart valve) to a target implantation site within a patient. In some embodiments, the capsule can have a reduced effective length during delivery of the prosthetic medical device to the target implantation site (e.g., as shown in FIGS. 5-10).

[0074] Method 300 begins at 302 and includes forming a tapered, narrower diameter portion of the capsule at a distal end portion of a delivery device such that the outer diameter of the distal end portion narrows radially inward from a wider intermediate portion of the capsule, the capsule being configured to be disposed over the distal end portion of the delivery device and to cover and retain a radially compressed prosthetic medical device therein. In some embodiments, the method includes forming the tapered, narrower diameter distal end portion of the capsule at 302 after loading the radially compressed prosthetic medical device into the capsule. Thus, the distal end portion can be in a radially expanded configuration during loading of the device into the capsule.

[0075] In some embodiments, forming the tapered narrower diameter portion of the capsule at 302 includes moving distal ends of a plurality of vanes forming the distal end portion of the capsule radially inward so that they are positioned adjacent to one another to form the narrower diameter portion of the capsule, each vane of the plurality of vanes being spaced from adjacent vanes of the plurality of vanes by an axially extending notch in the distal end portion. The method may further include narrowing a plurality of notches positioned between and separating the plurality of vanes at 302, wherein each notch of the plurality of notches is positioned between two adjacent vanes of the plurality of vanes, and radially expanding the distal end portion includes widening each notch of the plurality of notches.

[0076] In some embodiments, forming the tapered narrower diameter portion of the capsule at 302 includes radially inwardly compressing the distal ends of the plurality of vanes into a radially compressed configuration to set the vanes in the radially compressed configuration, such that the distal ends of the plurality of vanes are maintained in the radially compressed configuration until a radially outward force is applied by the prosthetic heart valve to the inner surfaces of the plurality of vanes during retraction of the capsule.

[0077] In other embodiments, the step of forming the tapered narrower diameter portion of the capsule at 302 includes allowing the distal ends of the plurality of wings to be retracted radially inward to an undeformed resting state, and elastically deforming the plurality of wings to an expanded state in which the distal ends of the plurality of wings are spaced further apart around the circumference of the distal end portion in response to retracting the capsule away from the prosthetic heart valve.

[0078] At 304, after forming the tapered, narrower diameter portion of the capsule, the method includes advancing the distal end portion of the delivery device to the target implantation site through the introducer sheath and sliding the outer surface of the intermediate portion of the capsule along the inner surface of the introducer sheath while the outer surface of the distal end portion of the capsule remains spaced from the inner surface of the introducer sheath.

[0079] In one example, to implant a prosthetic valve into the native aortic valve via a transfemoral delivery approach, an introducer sheath is first inserted into the femoral artery. The distal end portion of the delivery device and the prosthetic valve are advanced through the introducer sheath, into and through the descending aorta, and around the aortic arch toward the native aortic valve. In some examples, the delivery device is manipulated to position the prosthetic valve within the native aortic valve.

[0080] At 306, the method includes, in response to reaching a target implantation site for the prosthetic medical device (e.g., the heart in the case of a prosthetic heart valve), retracting the capsule axially away from the prosthetic medical device to radially expand the distal end portion so that the outer diameter of the distal end portion is equal to or greater than the diameter of the intermediate portion of the capsule.

[0081] In some embodiments, the distal end portion comprises an elastically deformable material, and the step of retracting the capsule away from the prosthetic heart valve to radially expand the distal end portion so that the outer diameter of the distal end portion is equal to or greater than the diameter of the intermediate portion of the capsule at 306 comprises elastically deforming the distal end portion radially outward in response to a force of the prosthetic heart valve sliding axially outward from the distal end portion of the capsule through the distal end portion of the capsule.

[0082] In some embodiments, a proximal end portion of the capsule, located opposite the intermediate portion from the distal end portion of the capsule, tapers radially inward from the intermediate portion. In these embodiments, while the capsule is being retracted from the prosthetic medical device at 306, the proximal end portion can remain tapered radially inward relative to the remainder of the capsule, including the intermediate and distal end portions. Thus, in some embodiments, only the distal end portion of the capsule is configured to expand radially, and the proximal end portion can remain tapered radially inward because the prosthetic medical device (e.g., a valve) can exit the capsule from the distal end of the capsule (without having to pass through the proximal end of the capsule).

[0083] In this manner, by configuring the capsule of the delivery device to have a narrowed (or tapered or smaller diameter) distal end portion, a narrowed proximal end portion, or both narrowed distal and proximal end portions, the amount of outer surface of the capsule that may contact the inner surface of the introducer sheath and / or the patient's anatomy may be reduced. As described herein, including these narrowed ends reduces the effective length of the capsule. As a result, potential deterioration of the sheath or the patient's anatomy may be reduced, and the push-through force experienced by the user of the delivery device during the implantation procedure may be reduced. Thus, the user experience may be improved. Furthermore, by forming the capsule of a flexible material and / or configuring it to have elastically or plastically deformable wings (formed by spaced notches), a prosthetic medical device may be more easily loaded into and removed from the capsule while still allowing the capsule to have a reduced effective length in the delivery configuration.

[0084] Alternative Delivery Techniques The preceding description describes a method for implanting a prosthetic valve into a native aortic valve via transfemoral delivery using the disclosed delivery device. However, it should be understood that the disclosed delivery device can be used to deliver a prosthetic valve (or other type of implantable medical device) to other natural annulus of the heart (pulmonary, mitral, and tricuspid valves), to blood vessels communicating with the heart (pulmonary artery, inferior vena cava, or superior vena cava), or to other locations within the body using any of a variety of delivery techniques.

[0085] For example, a prosthetic valve may be implanted within the native aortic valve in a transapical procedure, whereby the prosthetic valve (on the distal end portion of a delivery device) is introduced into the left ventricle through a surgical opening in the chest and the apex of the heart, and the prosthetic valve is positioned within the native aortic valve. Alternatively, in a transaortic procedure, the prosthetic valve (on the distal end portion of a delivery device) is introduced into the aorta through a surgical incision in the ascending aorta, such as a partial J-sternotomy or right parasternal mini-thoracotomy, and then advanced through the ascending aorta toward the native aortic valve.

[0086] When implanting a prosthetic valve into the native mitral valve via a transseptal delivery approach, the prosthetic valve is mounted in a radially compressed state along the distal end portion of a delivery device. The prosthetic valve and distal end portion of the delivery device are inserted into the femoral vein and advanced into the inferior vena cava, through the inferior vena cava, into the right atrium, across the atrial septum (through a hole created in the atrial septum), into the left atrium, and toward the native mitral valve. Alternatively, the prosthetic valve may be implanted into the native mitral valve in a transapical procedure, whereby the prosthetic valve (on the distal end portion of the delivery device) is introduced into the left ventricle through a surgical incision in the chest and the apex of the heart, and the prosthetic valve is positioned within the native mitral valve.

[0087] When implanting a prosthetic valve within the native tricuspid valve, the prosthetic valve is mounted in a radially compressed state along the distal end portion of a delivery device. The prosthetic valve and distal end portion of the delivery device are inserted into the femoral vein and advanced into the inferior vena cava and through the inferior vena cava into the right atrium, and the prosthetic valve is positioned within the native tricuspid valve. A similar approach can be used to implant a prosthetic valve within the native pulmonary valve or pulmonary artery, except that the prosthetic valve is advanced through the native tricuspid valve into the right ventricle and toward the pulmonary valve / pulmonary artery.

[0088] Another delivery approach is the transatrial approach, whereby the prosthetic valve (on the distal end portion of the delivery device) is inserted through an incision in the chest and an incision made through the atrial wall (of the right or left atrium) to access one of the native heart valves. Atrial delivery can also be performed intravascularly, such as through the pulmonary veins. Yet another delivery approach is the transventricular approach, whereby the prosthetic valve (on the distal end portion of the delivery device) is inserted through an incision in the chest and an incision made through the wall of the right ventricle (typically at or near the base of the heart) to implant the prosthetic valve in the native tricuspid valve, native pulmonary valve, or pulmonary artery.

[0089] In all delivery approaches, the delivery device may be advanced over a guidewire previously inserted into the patient's vasculature and / or over an introducer sheath previously inserted into the patient's vasculature. Furthermore, the disclosed delivery approaches are not intended to be limiting. Any of the prosthetic valves disclosed herein may be implanted using any of a variety of delivery procedures and delivery devices known in the art.

[0090] Additional Examples of the Disclosed Technology In light of the above-described embodiments of the disclosed subject matter, the present application discloses additional examples, as listed below. It should be noted that one feature of an example in isolation, or two or more features of an example taken in combination, and possibly two or more features of an example taken in combination with one or more features of one or more additional examples, are also additional examples that fall within the scope of the present application disclosure. [Example]

[0091] 1. A capsule of a delivery device configured to deliver a prosthetic medical device to a target implantation site, the capsule having at least one end portion located at a proximal or distal end of the capsule, the end portion narrowing in diameter from a wider outer diameter at an intermediate portion of the capsule to a narrower outer diameter at an end of the at least one end portion spaced from the intermediate portion of the capsule, the at least one end portion configured to expand to the wider outer diameter in response to radially outward pressure from the prosthetic medical device during removal of the prosthetic medical device from inside the capsule. [Example]

[0092] The capsule of any example herein, particularly example 1, wherein the at least one end portion is a distal end portion located at a distal end of the capsule. [Example]

[0093] The capsule of any example herein, particularly example 1, wherein the at least one end portion is a proximal end portion located at a proximal end of the capsule. [Example]

[0094] 10. The capsule of any example herein, particularly Example 1, wherein at least one end portion is a distal end portion disposed at a distal end of the capsule and further comprises a proximal end portion disposed at a proximal end, the proximal end portion narrowing in diameter from a wider outer diameter to a narrower diameter at the proximal end. [Example]

[0095] The capsule of any example herein, particularly Example 4, wherein only the distal end portion is configured to expand to a wider outer diameter, and the proximal end portion is configured to remain in its constricted configuration. [Example]

[0096] The capsule of any example herein, particularly any one of Examples 1 to 5, wherein at least one end portion includes a plurality of elongated notches spaced apart from one another around the circumference of the at least one end portion and extending from an end of the at least one end portion to a portion of the capsule where the at least one end portion transitions to an intermediate portion of the capsule. [Example]

[0097] The capsule of any example herein, particularly example 6, wherein at least one end portion further comprises a plurality of wings formed by a plurality of notches, each of the plurality of wings being formed between two adjacent notches of the plurality of notches. [Example]

[0098] The capsule of any example herein, particularly Example 7, wherein each vane is axially oriented along the central longitudinal axis of the capsule and angled radially inward from a wider proximal end of the vane to a narrower distal end of the vane, the distal ends of the vanes forming an end of at least one end portion of the capsule spaced from a middle portion of the capsule. [Example]

[0099] The capsule of any example herein, particularly any one of Examples 6 to 8, wherein each notch comprises an elongated end extending from an end of the at least one end portion to a portion of the capsule where the at least one end portion transitions to a middle portion of the capsule, and a bulbous end disposed in the portion of the capsule where the at least one end portion transitions to the middle portion of the capsule. [Example]

[0100] The capsule of any example herein, particularly any one of Examples 1 to 9, comprising a resilient, self-expanding metallic or polymeric material. [Example]

[0101] The capsule of any example herein, particularly example 10, comprising a shape memory material comprising a nickel titanium alloy. [Example]

[0102] The capsule of any example herein, particularly any one of Examples 1 to 11, wherein at least one end portion of the capsule is configured to be plastically deformed or set into a delivery configuration in which the at least one end portion narrows relative to a middle portion of the capsule such that the end of the at least one end portion has a narrower outer diameter. [Example]

[0103] The capsule of any example herein, particularly any one of Examples 1 to 9, wherein the at least one end portion is configured to elastically deform from a delivery configuration in which the at least one end portion narrows relative to a middle portion of the capsule such that an end of the at least one end portion has a narrower outer diameter, to an expanded configuration in which the at least one end portion expands to a wider outer diameter. [Example]

[0104] The capsule of any example herein, particularly any one of Examples 1 to 9 and 13, wherein at least one end portion of the capsule comprises an elastomeric material that is deformed into a tapered shape narrowing in diameter from a wider outer diameter at a middle portion of the capsule to a narrower outer diameter at an end of the at least one end portion spaced from the middle portion of the capsule. [Example]

[0105] 14. The capsule of any of the embodiments herein, particularly any one of embodiments 1 to 14, wherein the capsule is configured to cover and encapsulate a prosthetic medical device in a radially compressed configuration, the radially compressed prosthetic medical device having at least one tapered end configured to surround at least one end portion. [Example]

[0106] 1. A delivery device comprising: an outer shaft; a nosecone coupled to a distal end of an inner shaft of the delivery device disposed within at least a portion of the outer shaft; and a capsule coupled to the distal end of the outer shaft proximal to the nosecone and configured to move axially relative to the nosecone, wherein the capsule comprises a cylindrical intermediate portion having a first outer diameter along its length; and end portions configured to move between the first and second configurations, wherein in the first configuration the end portion tapers radially inward from the intermediate portion such that the end portion has a reduced diameter relative to the outer diameter of the intermediate portion, and in the second configuration the end portion is expanded to have an expanded diameter that is greater than the reduced diameter. [Example]

[0107] The delivery device of any example herein, particularly example 16, wherein the expanded diameter is equal to or greater than the outer diameter of the intermediate section. [Example]

[0108] The delivery device of any example herein, particularly example 16 or 17, wherein the end portion is a distal end portion of a capsule. [Example]

[0109] The delivery device of any example herein, particularly example 18, wherein the distal end portion comprises a proximal end disposed adjacent to the intermediate portion and having an outer diameter equal to the outer diameter of the intermediate portion, and the distal end portion comprises a distal end spaced apart from the intermediate portion and having an outer diameter smaller than the outer diameter of the intermediate portion. [Example]

[0110] A delivery device as described in any of the examples herein, particularly example 19, wherein the distal end of the distal end portion is configured to be positioned within the proximal end of the nose cone in a delivery configuration of the delivery device in which the capsule covers the radially compressed prosthetic heart valve. [Example]

[0111] The delivery device of any example herein, particularly example 18, wherein the capsule further comprises a proximal end portion having an outer diameter the same as the outer diameter of the intermediate portion. [Example]

[0112] The delivery device of any example herein, particularly example 18, wherein the capsule further comprises a proximal end portion that tapers radially inward from the intermediate portion such that the proximal end portion has a reduced diameter relative to an outer diameter of the intermediate portion. [Example]

[0113] The delivery device of any example herein, particularly example 22, wherein the proximal end portion remains tapered radially inward from the intermediate portion when the distal end portion is in the second configuration. [Example]

[0114] A delivery device described in any embodiment herein, particularly any one of embodiments 16 to 23, wherein the end portion comprises a plurality of elongated notches spaced apart from one another around the circumference of the end portion and extending axially from an end of the end portion spaced apart from the intermediate portion to a transition between the end portion and the intermediate portion of the capsule. [Example]

[0115] A delivery device as described in any example herein, particularly example 24, wherein the end portion further comprises a plurality of wings formed by a plurality of notches, each of the plurality of wings being formed between two adjacent notches of the plurality of notches. [Example]

[0116] A delivery device as described in any example herein, particularly example 25, wherein each vane is axially oriented relative to the central longitudinal axis of the capsule and angled radially inward from a wider proximal end of the vane to a narrower distal end of the vane, the distal ends of the vanes forming the ends of an end portion of the capsule. [Example]

[0117] A delivery device as described in any example herein, particularly any one of Examples 24 to 26, wherein each notch includes a wider end located at the transition between the end portion and the intermediate portion and an elongated end extending between the wider end and the end of the end portion, and the width of the wider end is greater than the width of the elongated end. [Example]

[0118] The delivery device of any example herein, particularly any one of examples 16 to 27, wherein the capsule comprises a resilient, self-expanding metallic or polymeric material. [Example]

[0119] The delivery device of any example herein, particularly example 28, wherein the capsule comprises a nickel titanium alloy. [Example]

[0120] A delivery device described in any example herein, particularly any one of examples 16 to 27, wherein the end portion of the capsule comprises an elastomeric material configured to elastically deform between a first configuration and a second configuration. [Example]

[0121] The delivery device of any example herein, particularly any one of Examples 16 to 30, wherein the length of the portion of the capsule having a diameter equal to or greater than the outer diameter of the intermediate portion of the capsule is longer in the second configuration than in the first configuration. [Example]

[0122] A delivery device as described in any example herein, particularly any one of examples 16 to 31, wherein the capsule, when in the first configuration, is configured to cover and encapsulate the prosthetic heart valve in a radially compressed configuration, the radially compressed prosthetic heart valve having at least one tapered end configured to be surrounded by an end portion. [Example]

[0123] The method includes, in response to and during actuating a capsule of a delivery device axially away from a radially compressed prosthetic medical device disposed on the distal end portion of the delivery device, radially expanding a distal end portion of the capsule from a constricted configuration in which an outer diameter of the distal end portion is smaller than an outer diameter of an intermediate portion of the capsule to an expanded configuration in which an outer diameter of the distal end portion is equal to or greater than the outer diameter of the intermediate portion to reveal the radially compressed prosthetic medical device. [Example]

[0124] The method of any example herein, particularly example 33, wherein the step of radially expanding the distal end portion occurs while the proximal end portion of the capsule remains in a constricted configuration, wherein in the constricted configuration, the proximal end of the proximal end portion has an outer diameter that is smaller than the outer diameter of the intermediate portion. [Example]

[0125] The method of any example herein, particularly example 33 or 34, wherein the intermediate portion of the capsule is disposed between and adjacent to each of the distal and proximal end portions of the capsule. [Example]

[0126] The method of any example herein, particularly example 35, wherein in the constricted configuration, the distal end portion narrows in diameter along its length from a proximal end of the distal end portion disposed adjacent the intermediate portion of the capsule to a distal end of the distal end portion. [Example]

[0127] The method of any example herein, particularly example 35 or 36, wherein in the constricted configuration, the proximal end portion narrows in diameter along its length from a distal end of the proximal end portion disposed adjacent the intermediate portion of the capsule to a proximal end of the proximal end portion. [Example]

[0128] The method of any example herein, particularly any one of Examples 33 to 37, wherein the capsule is in a constricted configuration while advancing at least a distal end portion of the delivery device through the introducer sheath and the patient's inner lumen to a target implantation site for a prosthetic medical device disposed on the distal end portion of the delivery device within the capsule. [Example]

[0129] The method of any example herein, particularly example 38, wherein the prosthetic medical device is a prosthetic heart valve. [Example]

[0130] The method of any example herein, particularly any one of examples 33 to 39, wherein the step of radially expanding the distal end portion of the capsule includes separating distal ends of a plurality of wings spaced around the circumference of the distal end portion from one another and moving the distal ends of the plurality of wings radially outward. [Example]

[0131] The method of any embodiment herein, particularly embodiment 40, wherein separating and moving radially outward the distal ends of the plurality of vanes includes widening a plurality of notches in the distal end portions, each notch of the plurality of notches being disposed between two adjacent vanes of the plurality of vanes. [Example]

[0132] The method described in any of the examples herein, particularly example 40 or 41, wherein the step of radially expanding the distal end portion of the capsule corresponds to a radially outward force applied by the outer surface of the prosthetic medical device to the inner surface of the plurality of wings as the capsule is moved axially away from the prosthetic medical device across a larger diameter portion of the outer surface of the prosthetic medical device. [Example]

[0133] The method of any example herein, particularly any one of Examples 40 to 42, wherein the step of radially expanding the distal end portion of the capsule includes elastically deforming the plurality of wings such that the wings move radially outward to an expanded configuration in response to an outward radial force, and further includes returning the plurality of wings to a constricted configuration after the outward axial force is removed after moving the capsule away from the prosthetic medical device. [Example]

[0134] forming a tapered, narrower diameter portion of the capsule of a delivery device at the distal end portion of the capsule so that the outer diameter of the distal end portion narrows radially inward from a wider intermediate portion of the capsule, the capsule being positioned on the distal end portion of the delivery device and configured to cover and hold a radially compressed prosthetic heart valve therein; and upon reaching a target implantation site for the prosthetic heart valve, retracting the capsule axially away from the prosthetic heart valve and radially expanding the distal end portion so that the outer diameter of the distal end portion is equal to or greater than the diameter of the intermediate portion of the capsule. [Example]

[0135] The method described in any example herein, particularly example 44, further comprising, after the step of forming the tapered, narrower diameter portion of the capsule, advancing the distal end portion of the delivery device to the target implantation site through the introducer sheath and while sliding the outer surface of the intermediate portion of the capsule along the inner surface of the introducer sheath, while the outer surface of the distal end portion of the capsule remains spaced apart from the inner surface of the introducer sheath. [Example]

[0136] The method of any of the embodiments herein, particularly embodiment 44 or 45, wherein the step of forming the tapered narrower diameter portion of the capsule includes moving distal ends of a plurality of vanes forming the distal end portion of the capsule radially inward so that they are positioned proximal to one another to form the narrower diameter portion of the capsule, and each vane of the plurality of vanes is spaced from an adjacent vane of the plurality of vanes by an axially extending notch in the distal end portion. [Example]

[0137] The method of any example herein, particularly example 46, wherein the step of forming the tapered, narrower diameter portion of the capsule further includes narrowing a plurality of notches disposed between and separating the plurality of vanes, each notch of the plurality of notches being disposed between two adjacent vanes of the plurality of vanes, and radially expanding the distal end portion includes widening each notch of the plurality of notches. [Example]

[0138] The method of any of the embodiments herein, particularly embodiment 46 or 47, wherein the step of forming the tapered narrower diameter portion of the capsule includes radially inwardly compressing the distal ends of the plurality of vanes into a radially compressed configuration to set the vanes in a radially compressed configuration, such that the distal ends of the plurality of vanes are maintained in the radially compressed configuration until a radially outward force is applied by the prosthetic heart valve to the inner surface of the plurality of vanes while the capsule is being retracted. [Example]

[0139] The method of any of the embodiments herein, particularly embodiment 46 or 47, wherein the step of forming the tapered, narrower diameter portion of the capsule includes allowing the distal ends of the plurality of wings to retract radially inward to an undeformed, resting state, and elastically deforming the plurality of wings to an expanded state in response to retracting the capsule away from the prosthetic heart valve, in which the distal ends of the plurality of wings are spaced further apart from one another around the circumference of the distal end portion. [Example]

[0140] The method of any of the embodiments herein, particularly embodiment 44 or 45, wherein the distal end portion comprises an elastomeric material, and wherein retracting the capsule away from the prosthetic heart valve to radially expand the distal end portion so that the outer diameter of the distal end portion is equal to or greater than the diameter of the intermediate portion of the capsule comprises elastically deforming the distal end portion radially outward in response to a force of the prosthetic heart valve sliding axially outward from the distal end portion of the capsule and through the distal end portion of the capsule. [Example]

[0141] The method of any example herein, particularly any one of Examples 44 to 50, wherein a proximal end portion of the capsule, located opposite the intermediate portion from the distal end portion of the capsule, tapers radially inward from the intermediate portion, and while retracting the capsule away from the prosthetic heart valve, the proximal end portion remains tapered radially inward relative to the remainder of the capsule, including the intermediate portion and the distal end portion. [Example]

[0142] 1. A method comprising: forming a tapered, narrower diameter portion of the capsule of a delivery device at a distal end portion of the capsule such that the outer diameter of the distal end portion narrows radially inward from a wider intermediate portion of the capsule; wherein the capsule is positioned over the distal end portion of the delivery device and is configured to cover and hold a radially compressed prosthetic heart valve therein; and wherein the distal end portion of the capsule is configured to expand radially outward in response to radially outward pressure from the prosthetic heart valve during removal of the prosthetic heart valve from inside the capsule such that the outer diameter of the distal end portion along its length is equal to or greater than the diameter of the intermediate portion of the capsule.

[0143] In view of the many possible embodiments to which the principles of the disclosed technology may be applied, it should be recognized that the illustrated embodiments are merely preferred examples of the disclosed technology and should not be taken as limiting the scope of the claimed subject matter. Rather, the scope of the claimed subject matter is defined by the following claims and their equivalents. [Explanation of symbols]

[0144] 10 Prosthetic heart valves, prosthetic valves 12 frames 14 Valve-like structure 16 pillars 18 Apex 20 Inlet end, inflow end 22 Outflow end 24 pillars 26 Aperture 28 Pointed 30 Joint surface 32 Sutures 34 Inner skirt 36 Suture 100 Delivery device 132 Handle part 134 First shaft, outer shaft 136 Knob 138a Dials, buttons 138b Dials, buttons 140 Proximal end portion 142 Distal end section 144 Nosecone 146 Delivery Capsules 152 Second shaft, inner shaft 154 Guidewire 155 Proximal Port 200 Delivery device 202 capsules 204 outer shaft 206 Prosthetic Medical Devices 208 outer diameter 210 Length, total length 212 Inner diameter 220 capsules 222 Distal end section 224 Middle part 226 First Diameter 228 Second Diameter 230 Distal end section 232 narrower diameter 234 Outer surface 236 Effective Length 250 capsules 252 Distal end section 254 Proximal end portion 256 Middle part 258 First outer diameter 260 Second outer diameter 262 Effective Length 268 Central Longitudinal Axis 270 notches 271 Thin End 272 Distal end 273 More bulbous end 274 positions 276 Feather 278 Distal end 280 proximal end 300 ways

Claims

1. Forming a tapered, narrower diameter portion of the capsule at the distal end portion of a delivery device such that the outer diameter of the distal end portion narrows radially inward from a wider intermediate portion of the capsule, the capsule being positioned on the distal end portion of the delivery device and configured to cover and retain a radially compressed prosthetic heart valve therein. Including, wherein the distal end portion of the capsule is configured to radially expand in response to radially outward pressure from the prosthetic heart valve during removal of the prosthetic heart valve from inside the capsule such that an outer diameter of the distal end portion along its length is equal to or greater than a diameter of an intermediate portion of the capsule.

2. The method of claim 1, wherein the step of forming the tapered narrower diameter portion of the capsule includes moving distal ends of a plurality of vanes forming the distal end portion of the capsule radially inward so that they are positioned proximal to one another to form the narrower diameter portion of the capsule, and each vane of the plurality of vanes is separated from adjacent vanes of the plurality of vanes by an axially extending notch in the distal end portion.

3. The method described in claim 2, wherein the step of forming the tapered, narrower diameter portion of the capsule further includes narrowing a plurality of notches disposed between and separating the plurality of vanes, each notch of the plurality of notches being disposed between two adjacent vanes of the plurality of vanes, and each notch of the plurality of notches being configured to widen as the distal end portion expands radially.

4. A method as described in claim 2 or 3, wherein the step of forming the tapered narrower diameter portion of the capsule includes compressing the distal ends of the plurality of vanes radially inward into a radially compressed configuration and setting the vanes in the radially compressed configuration so that the vanes are maintained in the radially compressed configuration until a radially inward force is applied to the inner surfaces of the plurality of vanes by the prosthetic heart valve.

5. A method as described in claim 2 or 3, wherein the step of forming the tapered narrower diameter portion of the capsule includes allowing the distal ends of the plurality of vanes to retract radially inward to an undeformed resting state, and elastically deforming the plurality of vanes in response to radially inward pressure from the prosthetic heart valve to an expanded state in which the distal ends of the plurality of vanes are spaced further apart from one another around the outer circumference of the distal end portions.

6. A method as described in claim 2 or 3, wherein the distal end portion comprises an elastomeric material and is configured to elastically deform radially outward in response to the radially outward pressure from the prosthetic heart valve.

7. A method described in any one of claims 1 to 6, wherein a proximal end portion of the capsule, which is located on the opposite side of the intermediate portion from the distal end portion of the capsule, is tapered radially inward from the intermediate portion, and the proximal end portion is configured to remain tapered radially inward relative to the remainder of the capsule including the intermediate portion and the distal end portion during radial expansion of the distal end portion.

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