Paravalvular sealing via extended cuff mechanisms

A prosthetic heart valve 300 may include a collapsible and expandable stent 306 having a proximal end 302, a distal end 304, an annulus section adjacent the proximal end, and a plurality of cells connected to one another in annular rows around the stent, a cuff 312 attached to the stent, and a sealing member 322 attached to the cuff and extending from a proximal end 313 of the cuff to a free edge 323. The sealing member 322 may be movable between an extended condition in which the free edge 323 is located proximally of the proximal end 302 of the stent 306, and an inverted condition in which the free edge is located distally of the proximal end of the stent and a first surface 324 of the sealing member confronts an outward-facing surface of the cuff. Various mechanisms for moving the sealing member 322 are also described.

BACKGROUND OF THE INVENTION

The present disclosure relates in general to heart valve replacement and, in particular, to collapsible prosthetic heart valves. More particularly, the present disclosure relates to devices and methods for positioning and sealing collapsible prosthetic heart valves within a native valve annulus.

Prosthetic heart valves that are collapsible to a relatively small circumferential size can be delivered into a patient less invasively than valves that are not collapsible. For example, a collapsible valve may be delivered into a patient via a tube-like delivery apparatus such as a catheter, a trocar, a laparoscopic instrument, or the like. This collapsibility can avoid the need for a more invasive procedure such as full open-chest, open-heart surgery.

Collapsible prosthetic heart valves typically take the form of a valve structure mounted on a stent. There are two common types of stents on which the valve structures are ordinarily mounted: a self-expanding stent or a balloon-expandable stent. To place such valves into a delivery apparatus and ultimately into a patient, the valve must first be collapsed or crimped to reduce its circumferential size.

When a collapsed prosthetic valve has reached the desired implant site in the patient (e.g., at or near the annulus of the patient's heart valve that is to be replaced by the prosthetic valve), the prosthetic valve can be deployed or released from the delivery apparatus and re-expanded to full operating size. For balloon-expandable valves, this generally involves releasing the entire valve, and then expanding a balloon positioned within the valve stent. For self-expanding valves, on the other hand, the stent automatically expands as the sheath covering the valve is withdrawn.

BRIEF SUMMARY OF THE INVENTION

Described herein is a prosthetic heart valve configured to be expanded proximate a native valve of a patient. The prosthetic heart valve may include a collapsible and expandable stent having a proximal end, a distal end, an annulus section adjacent the proximal end, and a plurality of cells connected to one another in a plurality of annular rows around the stent, a cuff attached to the annulus section of the stent and defining an outward-facing surface, a plurality of prosthetic valve leaflets attached to the cuff, and a sealing member attached to the cuff and extending from a proximal end of the cuff to a free edge. The stent may have a flow direction extending from the proximal end of the stent toward the distal end of the stent. The sealing member may be movable between an extended condition in which the free edge is located proximally of the proximal end of the stent, and an inverted condition in which the free edge is located distally of the proximal end of the stent and a first surface of the sealing member confronts the outward-facing surface of the cuff.

Also described herein is another prosthetic heart valve configured to be expanded proximate a native valve of a patient. The prosthetic heart valve may include a collapsible and expandable stent having a proximal end, a distal end, an annulus section adjacent the proximal end, and a plurality of cells connected to one another in a plurality of annular rows around the stent, a cuff attached to the annulus section of the stent and defining an outward-facing surface, a plurality of prosthetic valve leaflets attached to the cuff, and a sealing member attached to the cuff and extending from a proximal end of the cuff to a free edge. The stent may have a flow direction extending from the proximal end of the stent toward the distal end of the stent. The sealing member may be movable between an extended condition in which the free edge is located a first distance proximally of the proximal end of the stent, and a compressed condition in which the free edge is located a second distance proximally of the proximal end of the stent.

Also described herein is a method of expanding a prosthetic heart valve proximate a native valve of a patient. The prosthetic heart valve may include a stent having proximal and distal ends, a cuff attached to the stent, and a sealing member extending from a proximal end of the cuff to a free edge.

The method may include collapsing the prosthetic heart valve into a delivery device such that the sealing member is in an extended condition in which the free edge is located proximally of the proximal end of the stent, inserting the delivery device into a patient, advancing the delivery device proximate an annulus of the native valve, partially expanding the prosthetic heart valve in a selected position proximate the native valve, moving the sealing member from the extended condition to an inverted condition in which the free edge is located distally of the proximal end of the stent, and fully expanding the prosthetic heart valve.

Also described herein is a system including a delivery device and a prosthetic heart valve. The delivery device may include an operating handle and a catheter assembly. The catheter assembly may include a first shaft around which a compartment is defined, the first shaft being operatively connected to the operating handle, and a distal sheath at least partially surrounding the first shaft, the distal sheath being moveable between a closed condition covering the compartment and an open condition uncovering the compartment for deployment of the valve.

The prosthetic heart valve may be mounted in the compartment. The prosthetic valve may include a collapsible and expandable stent, a cuff, and a sealing member attached to the cuff. The stent may have a proximal end, a distal end, and an annulus section adjacent the proximal end, the stent having a flow direction extending from the proximal end toward the distal end. The cuff may be attached to the annulus section of the stent and may define an outward-facing surface.

The sealing member may extend from a proximal end of the cuff to a free edge, the sealing member being movable between an extended condition in which the free edge is located at a first location proximally of the proximal end of the stent, and a use condition in which the free edge is located at a second location distally of the first location and a first surface of the sealing member confronts the outward-facing surface of the cuff. The sealing member may have an energy storage element with a bias to move the sealing member toward the use condition. The catheter assembly may have a restraining member removably coupled to the sealing member to hold the sealing member in the extended condition against the bias of the energy storage element.

Also described herein is a system including a delivery device and a prosthetic heart valve. The delivery device may include an operating handle and a catheter assembly. The catheter assembly may include a first shaft around which a compartment is defined, the first shaft being operatively connected to the operating handle, and a distal sheath at least partially surrounding the first shaft, the distal sheath being moveable between a closed condition covering the compartment and an open condition uncovering the compartment for deployment of the valve.

The prosthetic heart valve may be mounted in the compartment. The prosthetic valve may include a collapsible and expandable stent, a cuff, and a sealing member attached to the cuff. The stent may have a proximal end, a distal end, and an annulus section adjacent the proximal end, the stent having a flow direction extending from the proximal end toward the distal end. The cuff may be attached to the annulus section of the stent and may define an outward-facing surface.

The sealing member may extend from a proximal end of the cuff to a free edge, the sealing member being movable between an extended condition in which the free edge is located at a first location proximally of the proximal end of the stent, and a use condition in which the free edge is located at a second location distally of the first location and a first surface of the sealing member confronts the outward-facing surface of the cuff. The catheter assembly may have an actuating filament having a portion removably coupled to the sealing member and configured to move the sealing member from the extended condition to the use condition when the portion of the actuating filament is moved toward the operating handle.

Also described herein is a system including a delivery device and a prosthetic heart valve. The delivery device may include an operating handle and a catheter assembly. The catheter assembly may include a first shaft around which a compartment is defined, the first shaft being operatively connected to the operating handle, and a distal sheath at least partially surrounding the first shaft, the distal sheath being moveable between a closed condition covering the compartment and an open condition uncovering the compartment for deployment of the valve.

The prosthetic heart valve may be mounted in the compartment. The prosthetic valve may include a collapsible and expandable stent, a cuff, and a sealing member attached to the cuff. The stent may have a proximal end, a distal end, and an annulus section adjacent the proximal end, the stent having a flow direction extending from the proximal end toward the distal end. The cuff may be attached to the annulus section of the stent and may define an outward-facing surface.

The sealing member may extend from a proximal end of the cuff to a free edge, the sealing member being movable between an extended condition in which the free edge is located at a first location proximally of the proximal end of the stent, and a use condition in which the free edge is located at a second location distally of the first location and a first surface of the sealing member confronts the outward-facing surface of the cuff. The catheter assembly may have an actuating filament removably coupled to a retaining element of the catheter assembly and configured to move the sealing member from the extended condition to the use condition when a portion of the actuating filament is moved toward the operating handle.

Also described herein is a system including a delivery device and a prosthetic heart valve. The delivery device may include an operating handle and a catheter assembly. The catheter assembly may include a first shaft around which a compartment is defined, the first shaft being operatively connected to the operating handle, and a distal sheath at least partially surrounding the first shaft, the distal sheath being moveable between a closed condition covering the compartment and an open condition uncovering the compartment for deployment of the valve.

The prosthetic heart valve may be mounted in the compartment. The prosthetic valve may include a collapsible and expandable stent, a cuff, a sealing member attached to the cuff, an expandable anchor portion having a generally cylindrical shape, and an actuating filament. The stent may have a proximal end, a distal end, and an annulus section adjacent the proximal end, the stent having a flow direction extending from the proximal end toward the distal end. The cuff may be attached to the annulus section of the stent and may define an outward-facing surface.

The sealing member may extend from a proximal end of the cuff to a free edge, the sealing member being movable between an extended condition in which the free edge is located at a first location proximally of the proximal end of the stent, and a use condition in which the free edge is located at a second location distally of the first location and a first surface of the sealing member confronts the outward-facing surface of the cuff. The actuating filament may extend between the free edge of the sealing member and the expandable anchor portion, the actuating filament configured to move the sealing member from the extended condition to the use condition when the expandable anchor portion is moved toward the operating handle.

Also described herein is a method of expanding a prosthetic heart valve proximate a native valve of a patient. The prosthetic heart valve may include a stent having proximal and distal ends, a cuff attached to the stent, and a sealing member extending from a proximal end of the cuff to a free edge.

The method may include collapsing the prosthetic heart valve into a delivery device such that the sealing member is in an extended condition in which the free edge is located proximally of the proximal end of the stent, inserting the delivery device into a patient, advancing the delivery device proximate an annulus of the native valve, expanding the prosthetic heart valve from a first diameter to a second diameter greater than the first diameter in a selected position proximate the native valve, and moving the sealing member from the extended condition to a use condition in which the free edge is located at a second location distally of the first location.

Various embodiments of the present disclosure will now be described with reference to the appended drawings. It is to be appreciated that these drawings depict only some embodiments of the disclosure and are therefore not to be considered limiting of its scope.

DETAILED DESCRIPTION

With conventional self-expanding valves, clinical success of the valve is dependent on accurate deployment and anchoring. Inaccurate deployment and anchoring of the valve increases risks, such as those associated with valve migration. Inaccurate deployment and anchoring may also result in the leakage of blood between the implanted heart valve and the native valve annulus, commonly referred to as perivalvular leakage (also known as “paravalvular leakage”). In aortic valves, this leakage enables blood to flow from the aorta back into the left ventricle, reducing cardiac efficiency and putting a greater strain on the heart muscle. Additionally, calcification of the aortic valve may affect performance and the interaction between the implanted valve and the calcified tissue is believed to be relevant to leakage, as will be outlined below.

Moreover, anatomical variations from one patient to another may cause a fully deployed heart valve to function improperly, requiring removal of the valve from the patient. Removing a fully deployed heart valve increases the length of the deployment procedure as well as the risk of infection and/or damage to heart tissue. Thus, methods and devices are desirable that reduce the need to remove a prosthetic heart valve from a patient. Methods and devices are also desirable that reduce the likelihood of perivalvular leakage due to gaps between the implanted heart valve and patient tissue.

As used herein, the term “proximal,” when used in connection with a prosthetic heart valve, refers to the end of the heart valve closest to the heart when the heart valve is implanted in a patient, whereas the term “distal,” when used in connection with a prosthetic heart valve, refers to the end of the heart valve farthest from the heart when the heart valve is implanted in a patient. When used in connection with devices for delivering a prosthetic heart valve or other medical device into a patient, the terms “proximal” and “distal” are to be taken as relative to the user of the delivery devices. “Proximal” is to be understood as relatively close to the user, and “distal” is to be understood as relatively farther away from the user. Also as used herein, the terms “generally,” “substantially,” “approximately,” and “about” are intended to mean that slight deviations from absolute are included within the scope of the term so modified.

When used to indicate relative locations within the aortic annulus, the aortic root, and the ascending aorta of a patient, the terms “above” and “below” are to be taken as relative to the juncture between the aortic annulus and the left ventricle. “Above” is to be understood as relatively farther from the left ventricle, and “below” is to be understood as relatively closer to the left ventricle.

When used to indicate relative locations within the prosthetic heart valve, the terms “longitudinal” and “vertical” are to be taken as the direction of the axis extending between the proximal end and the distal end of the heart valve, along the direction of intended blood flow; the term “flow direction” is to be taken as the direction from the proximal end to the distal end of the heart valve, along the direction of intended blood flow; and the terms “above,” “below,” “high,” and “low” are to be taken as relative to the proximal end of the prosthetic heart valve. “Above” and “high” are to be understood as relatively farther from the proximal end of the heart valve in the direction of intended blood flow, and “below” and “low” are to be understood as relatively closer to the proximal end of the stent in the direction of intended blood flow. When used to indicate relative locations within the prosthetic heart valve, the term “circumferential” is to be taken as the direction of rotation about the longitudinal axis of the stent.

The sealing portions of the present disclosure may be used in connection with collapsible prosthetic heart valves.FIG. 1shows one such collapsible stent-supported prosthetic heart valve100including stent102and valve assembly104as is known in the art. The prosthetic heart valve100is designed to replace a native tricuspid valve of a patient, such as a native aortic valve. It should be noted that while the embodiments herein are described predominantly in connection with their use with a prosthetic aortic valve and a stent having a shape as illustrated inFIG. 1, the valve could be a bicuspid valve, such as the mitral valve, and the stent could have different shapes, such as a flared or conical annulus section, a less-bulbous aortic section, and the like, and a differently shaped transition section.

Stent102may be formed from biocompatible materials that are capable of self-expansion, such as, for example, shape memory alloys, such as the nickel-titanium alloy known as “Nitinol” or other suitable metals or polymers. Stent102extends from proximal or annulus end130to distal or aortic end132, and includes annulus section140adjacent proximal end130, transition section141, and aortic section142adjacent distal end132. Annulus section140has a relatively small cross-section in the expanded condition, while aortic section142has a relatively large cross-section in the expanded condition. Annulus section140may be in the form of a cylinder having a substantially constant diameter along its length. Transition section141may taper outwardly from annulus section140to aortic section142.

Each of the sections of stent102includes a plurality of struts160forming cells162connected to one another in one or more annular rows around the stent. For example, as shown inFIG. 1, annulus section140may have two annular rows of complete cells162and aortic section142and transition section141may each have one or more annular rows of partial cells162. Cells162in aortic section142may be larger than cells162in annulus section140. The larger cells in aortic section142better enable prosthetic valve100to be positioned in the native valve annulus without the stent structure interfering with blood flow to the coronary arteries.

Stent102may include one or more retaining elements168at distal end132thereof, retaining elements168being sized and shaped to cooperate with female retaining structures (not shown) provided on the deployment device. The engagement of retaining elements168with the female retaining structures on the deployment device helps maintain prosthetic heart valve100in assembled relationship with the deployment device, minimizes longitudinal movement of the prosthetic heart valve relative to the deployment device during unsheathing or resheathing procedures, and helps prevent rotation of the prosthetic heart valve relative to the deployment device as the deployment device is advanced to the target location and the heart valve deployed.

Prosthetic heart valve100includes valve assembly104, preferably positioned in annulus section140of stent102and secured to the stent. Valve assembly104includes cuff176and a plurality of leaflets178that collectively function as a one-way valve by coapting with one another. As a prosthetic aortic valve, prosthetic heart valve100has three leaflets178. However, it will be appreciated that other prosthetic heart valves with which the sealing portions of the present disclosure may be used may have a greater or lesser number of leaflets178.

Although cuff176is shown inFIG. 1as being disposed on the luminal or inner surface of annulus section140, it is contemplated that cuff176may be disposed on the abluminal or outer surface of annulus section140or may cover all or part of either or both of the luminal and abluminal surfaces. Both cuff176and leaflets178may be wholly or partly formed of any suitable biological material or polymer such as, for example, polytetrafluoroethylene (PTFE), polyvinyl alcohol (PVA), ultra-high molecular weight polyethylene (UHMWPE), silicone, urethane, and the like.

Leaflets178may be attached along their belly portions to cells162of stent102, with the commissure between adjacent leaflets178attached to commissure features166. As can be seen inFIG. 1, each commissure feature166may lie at the intersection of four cells162, two of the cells being adjacent one another in the same annular row, and the other two cells being in different annular rows and lying in end-to-end relationship. Preferably, commissure features166are positioned entirely within annulus section140or at the juncture of annulus section140and transition section141. Commissure features166may include one or more eyelets that facilitate the suturing of the leaflet commissure to stent102.

Prosthetic heart valve100may be used to replace a native aortic valve, a surgical heart valve, a heart valve that has undergone a surgical procedure, or any other valve that is desired to be replaced. Prosthetic heart valve100may be delivered to the desired site (e.g., near or proximate a native annulus, near or proximate an annuloplasty ring or other repair device) using any suitable delivery device.

During delivery, prosthetic heart valve100is disposed inside the delivery device in the collapsed condition. The delivery device may be introduced into a patient using a transfemoral, transapical, transseptal, transradial, transsubclavian, transaortic or any other percutaneous approach. Once the delivery device has reached the target site, the user may deploy prosthetic heart valve100. Upon deployment, prosthetic heart valve100expands so that annulus section140is in secure engagement within the native annulus (or in engagement with an annuloplasty ring or other repair device). When prosthetic heart valve100is properly positioned, it works as a one-way valve, allowing blood to flow in an antegrade or flow direction, and preventing blood from flowing in the opposite direction.

Problems may be encountered when implanting prosthetic heart valve100. For example, in certain procedures, collapsible valves may be implanted in a native valve annulus without first resecting the native valve leaflets. The collapsible valves may have clinical issues because of the nature of the stenotic leaflets that are left in place. Additionally, patients with uneven calcification, bi-cuspid aortic valve disease, and/or valve insufficiency cannot be treated well, if at all, with the current collapsible valve designs.

The reliance on unevenly-calcified leaflets for proper valve placement and seating could lead to several problems, such as perivalvular leakage (“PV leak”), which can have adverse clinical outcomes. To reduce these adverse events, the optimal valve would anchor adequately and seal without the need for excessive radial force that could harm nearby anatomy and physiology.

PV leak may also be caused by the implantation of a valve having an expanded diameter that is too small relative to the native aortic annulus diameter, a prosthetic valve that is deployed in a tilted orientation relative to the native aortic annulus (such that the longitudinal axis of the valve and the native aortic annulus are misaligned), lack of full radial expansion of the valve due to the stent catching on calcific nodules in the native aortic annulus, and placing the valve at a non-optimal longitudinal position relative to the native aortic annulus (either too high or too low along the central axis of the native aortic annulus).

FIG. 2Ais a highly schematic cross-sectional illustration of prosthetic heart valve100disposed within native valve annulus250A. As seen in the figure, valve assembly104has a substantially circular cross-section which is disposed within the non-circular native valve annulus250A. At certain locations around the perimeter of heart valve100, gaps200A form between heart valve100and native valve annulus250A. Blood flowing through these gaps and past valve assembly104of prosthetic heart valve100can cause regurgitation and other inefficiencies which reduce cardiac performance. Such improper fitment may be due to suboptimal native valve annulus geometry due, for example, to calcification of native valve annulus250A or to unresected native leaflets.

FIG. 2Bis a similar cross-sectional illustration of prosthetic mitral valve100B disposed within native valve annulus250B. As seen in the figure, valve assembly104B has a substantially D-shaped cross-section that is disposed within irregularly-shaped annulus250B. At certain locations around the perimeter of heart valve100B, gaps200B form between heart valve100B and native valve annulus250B. Regurgitation and other inefficiencies may thus result after deployment of a prosthetic mitral valve. Though the following examples show aortic valves, it will be understood that the present devices and methods may be equally applicable to mitral and other heart valves.

FIGS. 3A-3Cillustrate prosthetic heart valve300in accordance with an embodiment of the disclosure. As can be seen inFIG. 3A, prosthetic heart valve300extends between proximal end302and distal end304, and may generally include stent306formed of a plurality of struts307, and valve assembly308having a plurality of leaflets310and cuff312.

Valve assembly308includes a generally cylindrical sealing member322that extends proximally from proximal end313of cuff312. The sealing member322may have smooth surfaces, rough or textured surfaces, or a combination of smooth surfaces with a rough or textured surface on one or more surfaces or surface portions to promote tissue ingrowth, which may improve sealing between the sealing member and the native patient anatomy. InFIG. 3A, sealing member322is shown in an extended condition. In some examples, sealing member322in its extended condition may extend between about 8 mm and about 16 mm proximally of proximal end302of stent306to free edge323.

One or more removable sutures330may extend through respective apertures in sealing member322adjacent its free edge323, and the free ends of each suture may extend proximally through a delivery device so as to be accessible to a user. In one example, one or more sutures330may be pulled by the user at the proximal end of the delivery device to move sealing member322from the extended condition (FIG. 3A) to an inverted condition (FIG. 3B), as will be described in greater detail below with reference toFIGS. 4E and 4F. In a variation, sutures330may be replaced with other filamentary elements that may extend between free edge323and the proximal end of the delivery device, such as at least one polymer wire, braided metal wire, Nitinol wire, cord, ribbon, or any other connecting member that may be used to pull sealing member322to an inverted condition (FIGS. 3B and 3C). In another variation (e.g.,FIGS. 10A-10C), one or more sutures330or other members may be pulled automatically during deployment of prosthetic heart valve300from a delivery device. A description of this variation is set forth in detail below.

InFIGS. 3B and 3C, sealing member322is shown in the inverted condition in which the sealing member may be annularly disposed around the abluminal surface of cuff312at proximal end302of stent306, such that a surface324of the sealing member that was facing radially outward from the longitudinal axis of stent306inFIG. 3Aconfronts the abluminal surface of the cuff. In other words, sealing member322is inverted and folded proximally over proximal end302of stent306. Proximal end313of cuff312where the cuff and sealing member322meet is disposed at the proximalmost junctions309aof the stent, and free edge323of sealing member322is disposed at or near upper junctions309bof the proximalmost struts307of stent306.

In the inverted condition, sealing member322may have a radius larger than that of the proximal end302of stent306, the larger radius of the sealing member being capable of filling gaps between prosthetic heart valve300and the native valve annulus and/or blocking blood flow through same.

To improve the capability of sealing member322to fill gaps between prosthetic heart valve300and the native valve annulus, sealing member322, and all of the other sealing members and rings described herein, may have an outward spring bias. Such an outward spring bias is preferably small enough that the sealing member may expand to different radial distances at some locations along the circumference of the sealing member than at other locations. The sealing member may expand a greater radial distance where there is minimal radial force applied to the sealing member from the native anatomy (i.e., at locations at which voids or gaps between stent306and the native anatomy are present, such as gaps200A shown inFIG. 2A). The sealing member may expand a lesser radial distance where there is greater radial force applied to the sealing member from the native anatomy (i.e., at locations at which there are no such voids or gaps).

Sealing member322may be formed of the same material as cuff312and may be formed integrally therewith from a single piece of material. Alternatively, sealing member322may be formed of the same material or a different material than cuff312that is sutured, glued or otherwise affixed to proximal end313of the cuff. In one example, sealing member322may be made of a thin tubular fabric material. In other examples, sealing member322may include thin porcine pericardial tissue between about 0.005 inches (127 μm) and about 0.007 inches (177.8 μm) in thickness, or ultra-high-molecular-weight polyethylene (UHMWPE) or polyethylene terephthalate (PET) fabric between about 0.003 inches (76.2 μm) and about 0.005 inches (127 μm) in thickness.

Alternatively, a variety of other materials may be used, including bovine tissue (e.g., glycerol impregnated or freeze dried), tissue with support structures therein, wire mesh, radiopaque wire, fabric, braided or woven fabric (e.g., polytetrafluoroethylene (PTFE), PET, or UHMWPE), fabric coated with PTFE or collagen, or a multi-layered composite of one or more of the aforementioned materials (e.g., a fabric and tissue composite). Any of the sealing rings or sealing members disclosed herein may be made of any one of the aforementioned materials or a combination thereof.

Sealing member322may be at least partially radiopaque, i.e., the sealing member may include one or more materials having enhanced visibility to a user under fluoroscopy. For example, sealing member322may be a fabric or wire mesh material having radiopaque fibers or may be comprised entirely of radiopaque fibers. Sealing member322may include radiopaque marker beads, a thin radiopaque wire, radiopaque paint, or may be impregnated with a radiopaque material such as silver, iodine, barium, platinum, or the like, such as by soaking the sealing member in a liquid including one or more of these chemicals. Any of the sealing members or sealing rings disclosed herein may include any one of the aforementioned radiopaque materials or a combination thereof.

Although the sutures330are described herein as extending through apertures in sealing member322adjacent its free edge323, the apertures need not be formed in the sealing member before the sutures are attached to the sealing member. The invention contemplates threading the sutures330directly through the material of sealing member322. For example, in an embodiment in which sealing member322is made of a fabric, sutures330may be threaded through gaps extending between fibers of the fabric, such that no additional apertures are created by the action of threading the sutures through the sealing member.

A method of inverting sealing member322during release of prosthetic heart valve300from distal sheath342of delivery device340(FIG. 4A) will now be described. Referring toFIG. 4A, prosthetic heart valve300is disposed in a compartment defined within distal sheath342of delivery device340, with the proximal end of the stent disposed adjacent distal tip344of the delivery device. InFIG. 4A, the compartment is slightly open, with distal end343of distal sheath342slightly spaced apart from distal tip344in the longitudinal direction L of delivery device340. As shown inFIG. 4B, distal sheath342has been withdrawn proximally in the longitudinal direction L, so that more of sealing member322has been uncovered and protrudes radially away from the longitudinal axis of delivery device340.

FIGS. 4C and 4Dshow distal sheath342withdrawn further in the proximal direction from distal tip344, so that the entire sealing member322has been uncovered and protrudes further radially away from the longitudinal axis of delivery device340. Removable sutures330can be seen inFIG. 4Dextending out of distal sheath342and through sealing member322at a location adjacent free edge323.

FIG. 4Eshows sealing member322being partially inverted relative to the extended condition shown inFIG. 4D. A user may begin to invert sealing member322by pulling on sutures330in the longitudinal direction L toward a proximal end (not shown) of delivery device340. Sutures330may extend from a location adjacent free edge323of sealing member322to the proximal end of delivery device340through a containment tube (not shown) extending within distal sheath342.

As can be seen inFIG. 4F, distal sheath342has been further withdrawn from the compartment, and sealing member322has been moved into the inverted condition. The proximal end302of stent306has been radially expanded, thereby tightening sealing member322against the stent and completing the inversion of the sealing member. After sealing member322has been inverted, a user may cut sutures330at the proximal end of delivery device340, and may pull one end of each suture until the suture withdraws from the apertures in sealing member322and from the delivery device.

In one example, in an embodiment in which sutures330are pulled automatically during deployment of prosthetic heart valve300from a delivery device, the sutures may remain in a patient with the cuff instead of being removed, which may help sealing member322maintain an inverted position under backpressure from blood flowing through the prosthetic heart valve. The backpressure may help pin sealing member322between stent306and the native anatomy of the patient, thereby anchoring the sealing member in place. In such an example, the sutures may be biodegradable.

Instead of a user cutting sutures330, the sutures may be released by a delivery device after sealing member322has been inverted. In a particular example, the delivery device may include a cutting mechanism that may be actuated by a user after sealing member322has been inverted to cut sutures330that may be removed from a patient along with the delivery device.

In another embodiment, sutures330may extend between sealing member322and a portion of a delivery device that may initially retain and later release the sutures from the delivery device. For example, such a portion may include a clip having an initial closed condition in which ends of sutures330are retained therein, and after sealing member322has been inverted, the clip may be opened by user actuation to release the sutures. In another example, such a portion may include a nitinol wire having an end extending out of a containment tube, the end of the wire having an initial hook-shaped condition (due to shape memory of the wire) in which ends of sutures330are retained thereon. After sealing member322has been inverted, the end of the wire may be retracted into the containment tube by user actuation to release the sutures. In such embodiments, at least a portion of sutures330may be left in the patient with the prosthetic heart valve300, and such a portion of the sutures may be biodegradable.

As shown inFIGS. 4A-4F, sealing member322is inverted before proximal end302of stent306has fully radially expanded. However, that need not be the case. In an alternative method of deployment, sealing member322may be inverted after proximal end302of stent306has fully radially expanded.

Other than sealing member322described above, all of the sealing members and sealing rings described herein have structures that may provide different surface areas and thicknesses of material at different longitudinal and circumferential positions relative to the stent to provide different advantages in sealing voids or gaps between the stent and the native anatomy when the heart valves are deployed into a patient. Such differences in surface areas and thicknesses of material at certain longitudinal and circumferential positions may make some sealing ring configurations preferable for certain native anatomies and other sealing ring configurations preferable for other native anatomies, depending on the anticipated locations of voids or gaps between a deployed prosthetic heart valve and the native anatomy. Such anticipated locations of voids or gaps between a deployed prosthetic heart valve and the native anatomy may be determined by a variety of methods, including imaging of the native anatomy before deployment of a prosthetic heart valve, for example.

FIGS. 5A and 5Billustrate heart valve300a, which is the same as heart valve300ofFIGS. 3A-3C, except that heart valve300aincludes a generally toroidal-shaped sealing ring325disposed adjacent free edge323of sealing member322a, which may permit prosthetic heart valve300ato achieve improved sealing against the native annulus and the native leaflets in some patients.

FIG. 5Ashows the inverted condition of sealing member322a, with sealing ring325attached to the sealing member at or near free edge323. Sealing ring325may be annularly disposed around the abluminal surface of stent306above proximal end302of the prosthetic heart valve (e.g., at a position that will lie within the native valve annulus when the prosthetic heart valve is deployed into a patient). Sealing ring325may have a radius larger than that of valve assembly308a, the larger radius of the sealing ring being capable of filling and/or blocking blood flow through gaps between prosthetic heart valve300aand the native valve annulus.

Sealing ring325may be formed of the same material as both sealing member322aand cuff312and may be formed integrally with both of these members from a single piece of material. In such an embodiment, sealing ring325may be a rolled end portion of sealing member322a. Cuff312, sealing member322a, and sealing ring325may be made of any one or more of the materials described above with respect to sealing ring322, such as, for example, a thin fabric material, thin porcine pericardial tissue, bovine tissue, tissue with support structures therein, braided or woven fabric, fabric coated with PTFE or collagen, or a multi-layered composite of one or more of the aforementioned materials.

Alternatively, sealing ring325may be formed of the same material or a different material than sealing member322athat is sutured, glued or otherwise affixed to sealing member322aadjacent free edge323. In such an embodiment, sealing ring325may be formed, for example, from a long, thin rectangle of material about 10 mm in width that is folded approximately in half longitudinally, and the opposed longitudinal edges may be stitched to one another to create a flattened tube about 4 mm in diameter. In other examples, such a flattened tube may be between about 2 mm and about 6 mm in diameter. The lateral ends of the flattened tube may be stitched to one another to create sealing ring325.

As can be seen inFIG. 5B, when sealing member322ais in the extended condition, sealing ring325is disposed on a surface326facing radially inward toward the longitudinal axis of stent306. When sealing member322ais moved to the inverted condition shown inFIG. 5A, using the method shown inFIGS. 4A-4Ffor example, surface326of the sealing member will face radially outward away from the longitudinal axis of stent306, and sealing ring325will face radially outward as well. When sealing member322ais in the extended condition (FIG. 5B), its typical condition when positioned within a delivery device, the entirety of sealing ring325lies below proximalmost junctions309aof stent306, enabling a smaller crimped profile to be achieved compared to when the sealing member is in the inverted condition (FIG. 5A).

Although sealing ring325is shown inFIGS. 5A and 5Bas having a circular cross-section, that need not be the case. Sealing ring325may be flattened in the flow direction, or it may have a cross-section that is square, rectangular, triangular, or other shapes. It is to be understood that all of the “sealing rings” described herein are not to be understood to be limited to having a circular cross-section. Any of the sealing rings described herein may be flattened in the flow direction, or they may have a cross-section that is square, rectangular, triangular, or other shapes.

FIG. 5Cillustrates heart valve300b, which is the same as heart valve300aofFIGS. 5A and 5B, except that heart valve300bincludes a second sealing ring327disposed adjacent sealing ring325. The presence of second sealing ring327along with sealing ring325may permit prosthetic heart valve300bto achieve improved sealing against the native annulus and the native leaflets in some patients.

When sealing member322ais in the inverted condition shown inFIG. 5C, second sealing ring327is disposed proximally of sealing ring325, between sealing ring325and proximalmost junctions309aof stent306, facing radially outward away from the longitudinal axis of the stent. When sealing member322ais in the extended condition (not shown), second sealing ring327is disposed distally of sealing ring325on surface326, facing radially inward toward the longitudinal axis of stent306.

In one example (not shown), second sealing ring327may be spaced apart from sealing ring325and positioned adjacent proximal end302of stent306when sealing member322ais in the inverted condition (e.g., at a position that will lie at least partially below the native valve annulus when the prosthetic heart valve is deployed into a patient). AlthoughFIG. 5Cshows sealing member322awith two sealing rings, the sealing member may include more than two sealing rings arranged sequentially along the sealing member.

Second sealing ring327may be formed of the same material as sealing member322a, and/or cuff312, and/or sealing ring325, and may be formed integrally with one or more of these members from a single piece of material. Alternatively, second sealing ring327may be formed of the same material or a different material than sealing member322a, and/or cuff312, and/or sealing ring325that is sutured, glued or otherwise affixed to sealing member322aadjacent sealing ring325. In such an embodiment, second sealing ring327may be formed, for example, from a long, thin rectangle of material about 10 mm in width that is folded approximately in half longitudinally, and the opposed longitudinal edges may be stitched to one another to create a flattened tube about 4 mm in diameter. The lateral ends of the flattened tube may be stitched to one another to create second sealing ring327.

When sealing member322bis in the extended condition (not shown), its typical condition when positioned within a delivery device, the entirety of both sealing ring325and sealing ring327lies below proximalmost junctions309aof stent306, enabling a smaller crimped profile to be achieved compared to when the sealing member is in the inverted condition (FIG. 5C). Although sealing rings325and327of prosthetic heart valve300bare shown inFIG. 5Cas having an identical structure, that need not be the case. In other embodiments, the two sealing rings may have structures that are different from one another, such as a combination of a flat toroidal sealing ring and a zig-zag sealing ring, such as sealing ring525eshown inFIG. 5Eand described below.

FIGS. 5D-5Gillustrate variants of sealing rings that may be used with prosthetic heart valves300aor300bin addition to or in place of the sealing rings shown inFIGS. 5A-5C. Each of sealing rings525d-525gshown inFIGS. 5D-5Gmay be formed in the same manner, attached to the sealing member in the same manner, and made of the same material or materials described above with reference to sealing rings325and327. Each of the sealing rings525d-525gmay be attached to a sealing member in any location along the longitudinal axis of the sealing member. A prosthetic heart valve, such as prosthetic heart valve300a, may include one of sealing rings525d-525g, or alternatively, the prosthetic heart valve may include two or more of the sealing rings, as shown inFIG. 5C.

FIG. 5Dshows sealing ring525din the shape of a bent or saddle-shaped toroid that alternates between peaks560dand valleys570daround the circumference of the sealing ring, the peaks and valleys being substantially evenly distributed about the circumference. As shown inFIG. 5D, sealing ring525dmay have two peaks560dand two valleys570d, but may have other numbers of peaks and valleys, such as three, for example, as will be described below with reference toFIGS. 6A and 6B.

FIG. 5Eshows sealing ring525ehaving a zig-zag shape that alternates between peaks560eand valleys570earound the circumference of the sealing ring, the peaks and valleys being substantially evenly distributed about the circumference. As shown inFIG. 5E, sealing ring525emay have nine peaks560eand nine valleys570e, but may have other numbers of peaks and valleys, such as three or six, for example. A sealing ring having a zig-zag shape may be stitched or otherwise attached to a cuff such that the sealing ring will generally follow the contour of the struts when the cuff is moved to an inverted condition such as that shown inFIG. 5A. However, in other embodiments, sealing ring525emay be attached to the cuff at other locations.

FIG. 5Fshows sealing ring525fhaving a zig-zag shape with alternating peak heights. Sealing ring525falternates between peaks560fand valleys570faround the circumference of the sealing ring, the peaks and valleys being substantially evenly distributed about the circumference. As shown inFIG. 5F, sealing ring525fmay have nine peaks560fand nine valleys570f, but may have other numbers of peaks and valleys, such as three or six, for example.

Peaks560finclude low peaks561that extend by a first height H1above valleys570fand high peaks562that extend by a second height H2above the valleys, the second height being greater than the first height. As shown inFIG. 5F, peaks560fmay include four low peaks561and four high peaks562, with one low peak separating adjacent ones of the high peaks. In other embodiments, there may be other numbers of high and low peaks. For example, a sealing ring having varying peak heights may include six low peaks and three high peaks, with two low peaks separating adjacent ones of the high peaks. In another example, a sealing ring having varying peak heights may include three low peaks and six high peaks, with two high peaks separating adjacent ones of the low peaks.

FIG. 5Gshows sealing ring525ghaving a toroidal shape, similar to the toroidal-shaped sealing ring325shown inFIGS. 5A and 5B. Sealing ring525ghas openings563in a top surface564thereof. Openings563may be round holes or may be holes having any other shapes or slits having any shape. Sealing ring525gmay be attached to a cuff of a prosthetic heart valve in a similar manner as that described above with reference to sealing ring325shown inFIGS. 5A and 5B.

When sealing ring525gis attached to a cuff of a prosthetic heart valve, openings563and top surface564will preferably face toward the distal end of the stent. When deployed in a patient, openings563may allow sealing ring525gto fill with blood, which may augment the ability of the sealing ring to seal against the native aortic annulus or other native tissue structures. Instead of or in addition to openings563, sealing ring525gmay include expanding materials within the interior of the sealing ring, such as polyacrylimide or other hydroscopic materials, PVA, shape memory foam, bovine gelatin or collagen, or the like. As these materials come in contact with blood, they expand, again augmenting the ability of the sealing ring to seal against the native tissue.

FIG. 5His a radial cross-section of sealing ring525hhaving features that may be incorporated into any of the sealing rings described herein. Sealing ring525hmay be formed in the same manner, attached to the cuff in the same manner, and made of the same material or materials as described above with reference to sealing rings325and327.

Top surface564of sealing ring525hmay be made of a porous material having many small openings563hthat are adapted to allow unidirectional blood flow into interior565of the sealing ring. Sealing ring525hmay have a bottom surface566without openings, and therefore may be substantially less permeable than top surface564. Bottom surface566may be made of a low-porosity material such as a tightly-woven fabric that may have a collagen or PVA coating, for example. Sealing ring525hmay be coated on the exterior of top surface564and/or bottom surface566with a material (e.g., Ag or a drug compound) to prevent a thrombus or infection from forming thereon. Blood that flows into interior565of sealing ring525hmay coagulate and/or in-grow into the material of sealing ring525h, which may help provide stiffness to the sealing ring in a radial direction.

FIGS. 6A-6Fillustrate prosthetic heart valve configurations that have embodiments of sealing rings that are variants of sealing ring325shown inFIGS. 5A and 5B, which sealing ring embodiments include stored energy elements in the form of springs that are configured to force portions of the outer edge of the sealing ring away from the cuff in locations at which voids or gaps between the stent and the native anatomy are present.

Each of sealing rings625a-625fshown inFIGS. 6A-6Fmay be formed in the same manner, attached to sealing member622in the same manner, moved to the inverted condition along with the sealing member in the same manner, and made of the same material or materials described above with reference to sealing ring325, with the exception of the addition of a stored energy element. Sealing rings625aand625c-625fmay each be attached to sealing member622in any position along the length of the sealing member. A prosthetic heart valve, such as prosthetic heart valve600, may include one of sealing rings625aor625c-625f, or alternatively, two or more of the sealing rings. Each of sealing rings625aand625c-625fmay be used to replace or to supplement sealing rings325and/or327in prosthetic heart valve300aor300b.

FIGS. 6A and 6Bshow sealing ring625ain the shape of a bent or saddle-shaped toroid similar to sealing ring525dshown inFIG. 5D, except that sealing ring625ahas three peaks660aand three valleys670asubstantially evenly distributed about the circumference of the sealing ring. Sealing ring625ahas a stored energy element in the form of coiled spring680athat extends continuously through the interior of the sealing ring or through substantial portions of the sealing ring.

At least partially due to the capability of spring680ato store energy, sealing ring625a(and the other sealing rings disclosed herein that incorporate spring elements) may have a spring bias that provides a force in a radially outward direction when the sealing ring is radially compressed. To provide this spring bias, each spring680a(and the other spring elements in the sealing rings disclosed herein) may be made from a material having a shape memory, such as nitinol wire or spring steel.

When prosthetic heart valve600is radially compressed inside a delivery device, spring680awill be under radial compression against its bias. When prosthetic valve600is initially released from the delivery device with sealing member622in the extended condition (not shown), sealing ring625awill be facing radially inward from the surface of the sealing member, and spring680awill radially expand according to the bias of the spring. When sealing member622is moved to the inverted condition shown inFIG. 6A, sealing ring625awill be facing radially outward from the surface of the sealing member, and spring680awill further radially expand so that outer edge628of sealing ring625awill move radially outward from inner edge629.

As shown inFIG. 6C, sealing ring625chas a plurality of stored energy elements in the form of springs680ccircumferentially spaced apart from one another about the interior of the sealing ring. Each spring680chas a first end681located at inner edge629of sealing ring625cand a second end682located at outer edge628. Each spring680cpreferably extends away from inner edge629in a direction substantially perpendicular to the flow direction through the stent to which sealing ring625cis attached. When a sealing member having sealing ring625cattached thereto is moved to an inverted condition such as that shown inFIG. 6A, second end682of each spring680cpreferably moves radially outward from inner edge629according to its bias, thereby pushing outer edge628of the sealing ring away from the inner edge. The springs680cmay each be flat leaf springs, or they may be portions of coil springs in the form of a spiral or a circular hoop. In embodiments where the springs680care in the form of a spiral or circular hoop, first end681and second end682of each spring are understood to be the portions of the spiral or circular hoop closest to inner edge629and outer edge628, respectively.

FIG. 6Dshows sealing ring625dthat is the same as sealing ring625cofFIG. 6C, except that each spring680dis oriented at an acute angle with respect to the circumference of the stent. When viewed from a top surface of sealing ring625d, as shown inFIG. 6D, springs680dmay be oriented in a clockwise direction about the longitudinal axis of the sealing ring from their first ends681to their second ends682. Alternatively, springs680dmay be oriented in a counterclockwise direction about the longitudinal axis of the sealing ring from their first ends681to their second ends682. The springs680dmay each be flat leaf springs, or they may be portions of coil springs in the form of a spiral or a circular hoop. In embodiments where the springs680dare in the form of a spiral or circular hoop, first end681and second end682of each spring are understood to be the portions of the spiral or circular hoop closest to inner edge629and outer edge628, respectively.

FIG. 6Eshows sealing ring625ethat is the same as sealing ring625aofFIGS. 6A and 6B, except that the stored energy element is in the form of leaf spring680ethat extends in at least one complete loop through the sealing ring, such that first end681and second end682of the spring overlap one another in the circumferential direction of the sealing ring. Similar to sealing ring625a, when a prosthetic valve having sealing ring625eis released from a delivery device and the sealing member is moved to the inverted condition shown inFIG. 6A, spring680ewill radially expand, such that outer edge628of the sealing ring moves radially outward from inner edge629according to the bias of the spring.

FIG. 6Fshows sealing ring625fthat is the same as sealing ring625eofFIG. 6E, except that leaf spring680fincludes ratchet element683that slidably couples either first end681or second end682of the spring to another portion of the spring. Ratchet element683includes first and second portions that move past one another to allow the leaf spring to radially expand, but that engage with one another to prevent the leaf spring from radially contracting. Similar to sealing ring625e, when a prosthetic valve having sealing ring625fis released from a delivery device and the sealing member is moved to the inverted condition shown inFIG. 6A, spring680fwill radially expand, such that outer edge628of the sealing ring moves radially outward from inner edge629according to the bias of the spring. Once spring680fhas expanded, it will substantially maintain its diameter due to the engagement of the first and second portions of ratchet element683, preventing the spring from re-collapsing to a smaller radial profile.

FIGS. 7A-7Cillustrate prosthetic heart valve700, which is the same as prosthetic heart valve300ofFIGS. 3A-3C, except that prosthetic heart valve700includes sealing member722that, rather than inverting, is configured to move from an extended condition shown inFIG. 7Bto a compressed or bunched condition shown inFIGS. 7A and 7Cwhich may permit prosthetic heart valve700to achieve improved sealing against the native annulus and the native leaflets in some patients. In the compressed condition, sealing member722may have a bunched shape somewhat resembling the bunched shape of a roman shade, in which peaks726droop to a position proximal of adjacent valleys724.

As can be seen inFIG. 7A, prosthetic heart valve700extends between proximal end702and distal end704, and may generally include stent706formed of a plurality of struts707, and valve assembly708having a plurality of leaflets and cuff712.

Valve assembly708includes a generally smooth sealing member722that extends from a proximal end713of cuff712. Proximal end721of sealing member722at which the cuff712and sealing member meet may be disposed at proximalmost junctions709aof stent706. In one example (not shown), proximal end721of sealing member722may be attached to cuff712and/or stent706between proximalmost junctions709aof stent706and upper junctions709bof the proximalmost struts of the stent. In other examples (not shown), proximal end721of sealing member722may be attached to cuff712and/or stent706anywhere along annulus section740of the stent, so that in the compressed condition, the sealing member may cover a portion of or all of the annulus section of the stent.

Sealing member722may include valley portions724and peak portions726that alternate in the longitudinal direction of stent706. A plurality of sutures730may extend through apertures732located within the valley portions. Sealing member722may include at least two sutures730, or a multitude of sutures spaced around the circumference thereof. Sutures730may extend from a location adjacent free edge723of sealing member722to the proximal end of a delivery device through a containment tube (not shown) extending within a distal sheath of the delivery device. When sealing member722is in the extended condition, shown inFIG. 7B, valley portions724and peak portions726may be generally flattened, such that the peak portions extend radially outward only a small distance relative to the valley portions.

In some embodiments, when sealing member722is in the extended condition, the valley portions724and peak portions726may be substantially completely flattened, so that the sealing member has a shape similar to the shape of sealing member322shown inFIG. 3A.

Removable sutures730may be pulled by a user to move sealing member722from the extended condition (FIG. 7B) to the compressed condition (FIGS. 7A and 7C). As the sutures are pulled by the user, free edge723of sealing member722is moved toward proximal end702of stent706. As free edge723moves distally, the material of sealing member722buckles at the locations of valley portions724and peak portions726, until the valley portions are pulled to a position adjacent one another with the peak portions extending radially outward therefrom. In the compressed condition of sealing member722shown inFIG. 7C, each peak726may droop below the adjacent proximal valley724. In other words, each peak726may have a central portion726athat extends proximally of the respective proximally adjacent valley724a.

In the extended condition of sealing member722shown inFIG. 7B, free edge723may be located a first distance proximally of proximal end702of stent706, and in the compressed condition of the sealing member shown inFIGS. 7A and 7C, the free edge may be located a second distance proximally of the proximal end of the stent, the first distance being greater than the second distance. Preferably, the first distance may be at least double the second distance. In other examples, the first distance may be at least triple the second distance, or the first distance may be at least quadruple the second distance.

Once sealing member722has been moved to the compressed condition, a user may cut sutures730at the proximal end of the delivery device, and may pull one end of each suture until the suture withdraws from apertures732in sealing member722and from the delivery device.

Similar to the alternative methods of deploying prosthetic heart valve300ahaving sealing member322ashown inFIGS. 4A-4F, sealing member722may be moved to the compressed condition either before proximal end702of stent706has fully radially expanded, or after the proximal end of the stent has fully radially expanded.

FIGS. 7D and 7Eillustrate sealing member722athat is a variant of sealing member722. In sealing member722a, apertures732through which removable sutures730extend are located between valleys724and peaks726of the sealing member. As a result, when sealing member722ais moved from the extended condition (FIG. 7D) to the compressed condition (FIG. 7E), the material of the sealing member buckles so that valleys724are located radially inward from apertures732, and peaks726are located radially outward from the apertures. In the compressed condition shown inFIG. 7E, sealing member722amay have a bunched shape somewhat resembling the bunched shape of a cellular shade, in which peaks726and valleys724may have a regular zig-zag pattern.

In the extended condition of sealing member722ashown inFIG. 7D, free edge723may be located a first distance proximally of proximal end702of stent706, and in the compressed condition of the sealing member shown inFIG. 7E, the free edge may be located a second distance proximally of the proximal end of the stent, the first distance being greater than the second distance. Preferably, the first distance may be at least double the second distance. In other examples, the first distance may be at least triple the second distance, or the first distance may be at least quadruple the second distance.

In a variant (not shown) of sealing members722and722ashown inFIGS. 7A-7E, the sealing members may be made of a material, such as a nitinol sheet, that is configured to move to the compressed condition shown inFIG. 7A, 7C, or7E when the material comes in contact with heat (e.g., the heat from a patient's bloodstream). In such a variant, sutures730may be omitted, because the sealing members can move from the extended condition to the compressed condition merely by retracting the distal sheath of the delivery device, without the need to pull on sutures.

In another variant (not shown) of sealing members722and722ashown inFIGS. 7A-7E, the sealing members may include one or more of any of the sealing rings shown and described above with reference toFIGS. 5A through 6F. Such sealing rings may extend circumferentially around an outwardly-facing surface of the sealing members722or722a.

Although the sutures730ofFIGS. 7A-7Eare described herein as extending through apertures in sealing member722and sealing member722a, the apertures need not be formed in the sealing member before the sutures are attached to the sealing member. The invention contemplates threading the sutures730directly through the material of sealing member722. For example, in an embodiment where sealing member722is made of a fabric, sutures730may be threaded through gaps extending between fibers of the fabric, such that no additional apertures are created by the action of threading the sutures through the sealing member.

In a variation, sutures730ofFIGS. 7A-7Emay be replaced with other filamentary elements, such as at least one polymer wire, braided metal wire, Nitinol wire, cord, ribbon, or any other connecting member that may be used to pull sealing member722to a compressed condition (e.g.,FIG. 7A, 7C, 7E.)

In another variant (e.g.,FIG. 8C), sutures730ofFIGS. 7A-7Emay be replaced with elastomeric elements that may automatically (i.e., without actuation by the user independent from actuation of the distal sheath) move sealing member722from the extended condition to the compressed condition during unsheathing of the valve. A description of this variation is set forth in detail below, with respect toFIG. 8C.

FIGS. 8A and 8Billustrate prosthetic heart valve800, which is the same as prosthetic heart valve300ofFIGS. 3A-3C, except that rather than having removable sutures330, prosthetic heart valve800includes retractable filaments830that are configured to shorten without being pulled by a user. Filaments830may extend along the outside surface of sealing member822and cuff812at spaced positions around the circumference of the sealing member from a proximal position832at which the filaments are attached at or adjacent free edge823of the sealing member to a position on stent806. Although filaments830are shown inFIGS. 8A and 8Bextending from proximal position832to distal position834at or near distal end804of stent806, that need not be the case. Distal position834at which filaments830are attached to stent806may be any location along the stent that will be located distally of free edge823of sealing member822when the sealing member moves to the inverted condition shown inFIG. 8B.

Filaments830may have an unstressed length and a shape memory such that, when a longitudinal force is applied to stretch the filaments to an extended length, the filaments have a spring bias that tends to shorten the filaments back to their unstressed length. Filaments830may be made from elastic sutures, for example, and preferably are made of a biocompatible material so that they may be left in a patient after the deployment of prosthetic heart valve800.

When prosthetic heart valve800is radially compressed within distal sheath842of delivery device840, sealing member822is radially compressed and held in the extended condition shown inFIG. 8Aby a frictional force acting between the distal sheath and the sealing member. In this extended condition, filaments830are stretched to their extended length so as to be under tension.

To move sealing member822from the extended condition to the inverted condition shown inFIG. 8B, the user may retract distal sheath842off of proximal end802of stent806, thereby removing the frictional force keeping the sealing member in the extended condition and filaments830at their extended length. Once distal sheath842is retracted, the tension in filaments830will cause them to shorten, thereby pulling free edge823of sealing member822in a distal direction and moving the sealing member to the inverted condition shown inFIG. 8B.

In an alternative embodiment, filaments830may be made from shrinkable nitinol, a shrinkable material that has a first extended length, and when the filaments are exposed to blood, the filaments shrink to a second contracted length less than the first extended length. In such an embodiment, the filaments830will not be under tension. Instead, when distal sheath842is retracted, filaments830will contact blood, and the resulting rise in the temperature of the filaments will cause them to shorten, thereby pulling free edge832of sealing member822in a distal direction and moving the sealing member to the inverted condition shown inFIG. 8B.

FIG. 8Cillustrates prosthetic heart valve800a, which is the same as prosthetic heart valve800, except that sealing member822ais configured to shorten to the compressed condition shown inFIGS. 7A-7E, rather than invert. When prosthetic heart valve800ais in an extended condition, it may look similar to the extended condition of prosthetic heart valve800shown inFIG. 8A. However, once the distal sheath of the delivery device is retracted off of proximal end802of stent806, filaments830will shorten as described above, thereby pulling free edge823of sealing member822ain a distal direction and moving the sealing member to the compressed condition shown inFIG. 8C.

Although filaments830are shown inFIG. 8Cextending from proximal position832to distal position834at or near distal end804of stent806, that need not be the case. Distal position834at which filaments830are attached to stent806may be any location along the stent that will be distal of free edge823of sealing member822awhen the sealing member moves to the compressed condition shown inFIG. 8C.

In an alternative embodiment (not shown), filaments830may be replaced with an elastomeric strip (and/or another energy storage element) stitched into or otherwise attached to sealing member822ain a tensioned state. In such an embodiment, the elastomeric strips will be under tension when sealing member822ais in the extended condition. When sealing member822aof prosthetic heart valve800ais unsheathed, the elastomeric strips may automatically contract, thereby moving sealing member822ato the compressed condition.

FIGS. 9A and 9Billustrate prosthetic heart valve900, which is the same as prosthetic heart valve800, except that sealing member922is biased to move to a rolled condition to form sealing ring925as shown inFIG. 9B, rather than to an inverted condition.

As can be seen inFIG. 9A, stent906may include a plurality of independent fingers911at spaced positions around the circumference of sealing member922, each finger extending proximally along sealing member922to a free end913at least 8 mm from one of proximalmost junctions909aof the stent. In other examples, each finger may extend proximally along sealing member922to a free end913at least mm from the proximalmost junction, or each finger may extend proximally along the sealing member to the free end at least 16 mm from the proximalmost junction. Free ends913of fingers911may be attached to sealing member922adjacent free edge923thereof. Fingers911may have a shape memory that tends to roll the fingers into the spiral shape shown inFIG. 9Bwhen the fingers are not being forced into a substantially straight configuration.

When prosthetic heart valve900is radially compressed within the distal sheath of a delivery device, sealing member922is radially compressed and held in the extended condition shown inFIG. 9Aby a frictional force acting between the distal sheath and the sealing member. In this extended condition, fingers911are straightened against their bias.

To move sealing member922from the extended condition to the rolled condition shown inFIG. 9B, the user may retract the distal sheath off of the proximal end902of stent906, thereby removing the force that is keeping the sealing member in the extended condition and fingers911in their straight configuration. Once the distal sheath is retracted, fingers911will assume the rolled condition, thereby rolling sealing member922outwardly in the direction of the distal end of stent906to form sealing ring925such that a distal surface923of the sealing ring is at substantially the same height as the proximalmost junctions909aof the stent.

As shown inFIG. 9B, sealing member922may be rolled into a generally toroidal-shaped sealing ring925near proximal end902of stent906(e.g., at a position that will lie at least partially below the native valve annulus when the prosthetic heart valve is deployed into a patient). Sealing ring925may be formed of one complete revolution of sealing member922, or of a series of revolutions (e.g., two, three or more revolutions of the sealing member).

Referring now toFIGS. 10A and 10B, an exemplary transfemoral delivery device10for collapsible prosthetic heart valves of the types described above (or other types of implantable medical devices) has catheter assembly16for delivering the heart valve to and deploying the heart valve at a target location, and operating handle20for controlling deployment of the valve from the catheter assembly. Delivery device10extends from proximal end12(FIG. 10B) to atraumatic tip14at the distal end of catheter assembly16. Catheter assembly16is adapted to receive a collapsible prosthetic heart valve (e.g., prosthetic heart valve300shown inFIGS. 3A-3C) in compartment23defined around inner shaft26and covered by distal sheath24.

Inner shaft26may extend through operating handle20and catheter assembly16to atraumatic tip14of the delivery device, and includes retainer25affixed thereto at a spaced distance from atraumatic tip14and adapted to hold a collapsible prosthetic valve in compartment23. Retainer25may have recesses80therein that are adapted to hold corresponding retention members of the valve. Inner shaft26may be made of a flexible material such as braided polyimide or polyetheretherketone (PEEK), for example. Using a material such as PEEK may improve the resistance of inner shaft26to kinking while catheter assembly16is tracking through the vasculature of a patient.

Distal sheath24surrounds inner shaft26and is slidable relative to the inner shaft such that it can selectively cover or uncover compartment23. Distal sheath24is affixed at its proximal end to outer shaft22, the proximal end of which is connected to operating handle20in a manner to be described below. Distal end27of distal sheath24abuts a proximally-facing abutment surface15of atraumatic tip14when the distal sheath is fully covering compartment23, and is spaced apart from the proximally-facing abutment surface15when the compartment is at least partially uncovered.

Operating handle20is adapted to control deployment of a prosthetic valve located in compartment23by permitting a user to selectively slide outer shaft22proximally or distally relative to inner shaft26, thereby respectively uncovering or covering the compartment with distal sheath24. In some examples, operating handle20is configured to repeatedly cover or uncover the compartment with distal sheath24. For example, compartment23may be uncovered to expose a valve and allow it to expand at a target location. Once at the location, the functionality and positioning of the valve may be examined prior to complete release of the valve. If the functioning or position of the valve is improper, distal sheath24may be advanced to cover the compartment and the valve may be redeployed in a different position or orientation.

Outer shaft22may be made of a flexible material such as nylon 11 or nylon 12, and may have a round braid construction (i.e., round cross-section fibers braided together) or a flat braid construction (i.e., rectangular cross-section fibers braided together), for example. The proximal end of inner shaft26may be connected in a substantially fixed relationship to outer housing30of operating handle20, and the proximal end of outer shaft22may be affixed to carriage assembly40that is slidable along a longitudinal axis of the handle housing, such that a user can selectively slide the outer shaft relative to the inner shaft by sliding the carriage assembly relative to the housing. A hemostasis valve28may be provided and may include an internal gasket adapted to create a seal between inner shaft26and the proximal end of outer shaft22.

Handle housing30includes a top portion30aand a bottom portion30b. The top and bottom portions30aand30bmay be individual pieces joined to one another as shown inFIG. 10B. Collectively, top and bottom portions30aand30bdefine elongated space34in housing30in which carriage assembly40may travel. Elongated space34preferably permits carriage assembly40to travel a distance that is at least as long as the anticipated length of the prosthetic valve to be delivered (e.g., at least about 20 mm, 45 mm, or 50 mm), such that distal sheath24can be fully retracted from around the prosthetic valve. Carriage assembly40has a body portion41with threaded rod36extending proximally therefrom along the longitudinal axis of housing30. Carriage assembly40may further include a pair of carriage grips42each attached to body portion41by a respective carriage grip shaft (not shown).

Handle housing30further defines a pocket37that extends through top portion30aand bottom portion30bfor receiving deployment actuator21. Deployment actuator21is internally threaded for selective engagement with threaded rod36. When deployment actuator21is in threaded engagement with threaded rod36, rotation of the deployment actuator in one direction (either clockwise or counterclockwise depending on the orientation of the threads on the threaded rod) causes the threaded rod to move proximally, at the same time pulling body portion41of carriage assembly40proximally through elongated space34, and pulling outer shaft22and distal sheath24proximally relative to inner shaft26. Similarly, when deployment actuator21is in threaded engagement with threaded rod36, rotation of the deployment actuator in the opposite direction causes the threaded rod to move distally through elongated space34, which pushes outer shaft22and distal sheath24distally relative to inner shaft26. When deployment actuator21is disengaged from threaded rod36, the threaded rod may be translated without rotation of the deployment actuator by a user grasping and moving carriage grips42.

Handle20may also include a resheathing lock adapted to limit the longitudinal movement of carriage assembly40proximally within handle housing30, thereby preventing the user from completing the deployment of a prosthetic valve unintentionally. The initial distance that carriage assembly40can travel before being limited by the resheathing lock may be about 80% to about 90% of the length of an exemplary 50 mm valve. Further details of the coupling assembly and embodiments of resheathing locks suitable for use with delivery device10are shown and described in co-pending and co-owned U.S. Patent Application Publication No. 2013/0297011, the disclosure of which is hereby incorporated by reference herein.

FIG. 10Cshows prosthetic valve300ofFIGS. 3A-3Ccoupled to delivery device10and having sealing member322in a partially inverted position. Delivery device10may include one or more removable sutures1030configured to automatically invert sealing member322of prosthetic heart valve300. Removable sutures1030may extend within a lumen of outer shaft22from compartment23to apertures46in carriage assembly40at which the proximal ends of the sutures may be connected. Sutures1030may take any of the forms and be made of any of the materials described above with respect to sutures330. Removable sutures1030may be connected at their distal ends to respective apertures in sealing member322adjacent its free edge323, and the free ends of each suture may extend proximally to operating handle20through outer shaft22of delivery device10.

Sutures1030may have proximal end portions1032that are connected to apertures46in carriage assembly40, thereby fixing the end portions of the sutures to the carriage assembly for movement therewith. End portions1032may be accessible for a user holding operating handle20to cut after inversion of sealing member322.

As shown inFIG. 10A, proximal end portions1032of sutures1030may be take the form of a single looped suture portion that extends around hemostasis valve28. In one example, proximal end portions1032of sutures1030may each terminate in a knot that is wider than the apertures46, such that the apertures may retain the proximal end portions in a fixed relationship to carriage assembly40. In another example, proximal end portions1032of sutures1030may be a single suture portion that extends between apertures46without extending around hemostasis valve28. In other examples, end portions1032of sutures1030may take any other form that permits a user access to the sutures for cutting and/or removal of the sutures from the delivery device10, and fixes the sutures to the carriage assembly40, so that the sutures may be pulled together with the carriage assembly.

To use operating handle20to deploy a prosthetic valve that has been loaded into the compartment23and covered by distal sheath24, the user may rotate deployment actuator21, causing carriage assembly40to slide proximally within elongated space34in housing30. Because distal sheath24is affixed to outer shaft22, which in turn is affixed to the carriage assembly40, and because inner shaft26is fixed to housing30, sliding the carriage assembly proximally relative to the housing will retract the distal sheath proximally from compartment23, thereby exposing and initiating deployment of the valve located therein.

Because end portions1032of sutures1030are affixed to carriage assembly40for movement therewith, as distal sheath24, outer shaft22, and the carriage assembly are moved proximally, the sutures pull free edge323of sealing member322in the longitudinal direction L toward proximal end12of delivery device10. This pulling of sutures1030causes sealing member322to automatically (i.e., without the user pulling the sutures independently of moving the carriage assembly) begin to move from the extended condition (FIG. 3A) to the inverted condition (FIG. 3B).

When the deployment procedure has reached a partial deployment of the valve, for example, deployment of about 80% of the length of the valve, the user can evaluate the position of the valve relative to the patient's aortic annulus and may be able to determine whether the valve is functioning properly. If repositioning or removal is desired, the user may resheath the valve, for example, by rotating deployment actuator21in the direction opposite that used for deployment. Such rotation will cause threaded rod36to progress distally through deployment actuator21until carriage assembly40has reached the starting position shown inFIG. 10B, thereby re-collapsing the expanded part of the valve as distal sheath24is moved distally over compartment and the partially deployed valve. With the valve resheathed, the user can reposition delivery device10and commence the deployment procedure once again or simply remove the valve from the patient.

Once the proper positioning of the valve relative to the aortic annulus has been assured, the user may complete the deployment process. The user can slide carriage assembly40proximally to complete the deployment of the valve by again rotating deployment actuator21in the first direction, thereby releasing the valve from catheter assembly16. With distal sheath24completely withdrawn from the compartment, and carriage assembly40at its proximalmost position (FIG. 10A), sealing member322will be in the inverted condition. After sealing member322has been inverted, a user may cut end portions1032of sutures1030that extend through apertures46of carriage assembly40. The user may then pull one end of each suture1030proximally until the suture withdraws from sealing member322and from apertures46of carriage assembly40.

Although the automatic sealing member inversion has been described above with respect to inverting the sealing member of prosthetic heart valve300ofFIG. 3A, that arrangement may be used to invert the sealing members of any of the other prosthetic heart valves described herein.

FIG. 11illustrates heart valve1100, which is the same as heart valve800ofFIGS. 8A and 8B, except that sealing member of1122of heart valve1100includes removable pegs1128that hold the sealing member in its initial extended condition until a user decides to move the sealing member to an inverted or contracted condition.

Prosthetic heart valve1100has energy storage elements1130that may be the filaments830described above. Energy storage elements1130may have an unstressed length and a shape memory such that, when a longitudinal force is applied to stretch the energy storage elements to an extended length, the energy storage elements have a spring bias that tends to shorten the energy storage elements back to their unstressed length. Energy storage elements1130may be made from elastic sutures or an elastomeric member, for example, and preferably are made of a biocompatible material so that they may be left in a patient after the deployment of prosthetic heart valve1100.

Removable pegs1128are configured to hold sealing member1122is its initial extended condition, such as the extended condition shown inFIG. 11. Pegs1128may be rigid reinforcements removably attached to sealing member1122that prevent the sealing member from folding to an inverted condition (e.g.,FIG. 8B) or a contracted condition (e.g.,FIG. 8C) until the pegs are detached from the sealing member by a user. Pegs1128are affixed to filaments1129(e.g., wires, sutures, or any of the other filamentary structures described above) that may extend from the pegs proximally to a delivery device handle, where they may be accessible for a user to pull.

Pegs1128may be removably coupled to sealing member1122, for example, by filaments such as sutures (not shown) that are configured to break when a threshold amount of force is applied thereto. One filament may couple a peg1128to sealing member1122adjacent free edge1123, and another filament may couple the peg to the sealing member adjacent proximal end1113of cuff1112. Alternatively, pegs1128may be removably coupled to sealing member1122by having each end of the peg engaged in a corresponding pocket (not shown) of the sealing member, for example, having one pocket adjacent free edge1123and another pocket adjacent proximal end1113of cuff1112. As shown inFIG. 11, filaments1129are affixed to the distal ends of pegs1128, however, in other embodiments, the filaments may be attached to other portions of the pegs.

When a user decides to move sealing member1122to an inverted condition (e.g.,FIG. 8B) or a contracted condition (e.g.,FIG. 8C), the user may grasp and pull the proximal ends of filaments1129in a proximal direction. The proximal force exerted on the pegs1128will detach the pegs from sealing member1122, thereby permitting energy storage elements1130to move the sealing member to the inverted or contracted position, in a manner similar to that described above with reference toFIG. 8B or 8C. Once pegs1128have been detached from sealing member1122, the user may advance the distal sheath of the delivery device (e.g., similar to the delivery device10shown inFIGS. 10A and 10B), at which point the pegs and the ends of filaments1129attached to the pegs are captured in the valve compartment, so that the pegs will not damage native tissue of the patient during withdrawal of the delivery device from the patient.

Pegs1128are preferably removed from sealing member1122before aortic end1132of prosthetic heart valve1100is fully radially expanded in order to eliminate the need to force the pegs between the aortic end of the valve and native tissue of the ascending aorta, potentially resulting in damage to the native tissue.

Although prosthetic heart valve1100is described as a variation of prosthetic heart valve800ofFIGS. 8A and 8B, prosthetic heart valve1100may alternatively be a variation of prosthetic heart valve900ofFIGS. 9A and 9B. In such a variation, the function of energy storage elements1130may be replaced by the energy storage function of independent fingers911, which have a shape memory that tends to roll the fingers into the spiral shape shown inFIG. 9Bwhen the fingers are not being held in a substantially straight configuration. In this variation, when pegs1128are detached from sealing member1122, independent fingers911will be free to assume a rolled condition according to their bias, rolling the sealing member to form a sealing ring (as shown inFIG. 9B).

FIGS. 12A-12Cillustrate prosthetic heart valve1200, which is a variation of prosthetic heart valve1100ofFIG. 11including a sealing member having an alternate version of the removable pegs. Prosthetic heart valve1200includes sealing member1222that has removable pegs1228that are configured to hold the sealing member in its initial extended condition (FIG. 12A) until a user decides to move the sealing member to a contracted condition (FIGS. 12B and 12C). Similar to pegs1128, pegs1228may be rigid reinforcements removably attached to sealing member1222that prevent the sealing member from folding to an inverted condition (e.g.,FIG. 8B) or a contracted condition (e.g.,FIG. 8C) until the pegs are detached from the sealing member by a user.

Prosthetic heart valve1200has energy storage elements that may be the same as those described above with respect toFIG. 11, although those energy storage elements are not shown inFIGS. 12A-12C. The energy storage elements are configured to move sealing member1222from its initial extended condition to its contracted condition.

Pegs1228are configured to hold sealing member1222is its initial extended condition, such as the extended condition shown inFIG. 12A. Similar to pegs1128, pegs1228may be removably coupled to sealing member1222, for example, by filaments such as sutures that are configured to break when a threshold amount of force is applied thereto, or by having each end of the peg engaged in a corresponding pocket of the sealing member.

Pegs1228are affixed to springs1229that may extend from the pegs proximally to their fixation to distal sheath24of a delivery device, such as delivery device10ofFIGS. 10A and 10B. Proximal end1221of each spring1229is affixed to distal sheath24, so that when the distal sheath is moved proximally by the user to deploy the prosthetic heart valve1200within a patient, the springs are stretched in the direction of the longitudinal axis of the distal sheath.

When the pulling force acting on pegs1228reaches a predetermined threshold amount, springs1229automatically (i.e., without the user pulling the springs independently of moving the distal sheath24) detach the pegs from sealing member1222, thereby permitting the energy storage elements to move the sealing member from the extended condition to the contracted condition, in a manner similar to that described above with reference toFIG. 8C. After pegs1228have been detached from sealing member1222, springs1229automatically pull the pegs into distal sheath24, as shown inFIG. 12C. Once pegs1228have been pulled into distal sheath24and the distal sheath has been moved to cover the valve compartment, the pegs will not damage native tissue of the patient during withdrawal of the delivery device from the patient.

Although prosthetic heart valve1200is shown as having a sealing member1222that is configured to move from an extended condition to a contracted condition similar to that shown inFIG. 8C, springs1229and pegs1228may also be used with prosthetic heart valves that are configured to move from an extended condition to an inverted condition, such as that shown inFIG. 8B.

FIG. 13Aillustrates prosthetic heart valve1300aand delivery device1310a, which is substantially the same as prosthetic heart valve300and delivery device10ofFIGS. 10A-10C. Delivery device1310aincludes sutures1330athat extend through catheter assembly1316afrom prosthetic heart valve1300ato handle1320a. Handle1320amay include a cutting mechanism (not shown) that is configured to cut end portions1332aof sutures1330aafter inversion of sealing member1322a. After end portions1332aare cut, a user may grasp one end of each suture1330aand pull the suture proximally to withdraw the suture from delivery device1310a.

FIG. 13Billustrates prosthetic heart valve1300band delivery device1310b, which is another variation of prosthetic heart valve300and delivery device10ofFIGS. 10A-10C. Delivery device1310bincludes sutures1330bthat extend through shaft1328within catheter assembly1316bfrom prosthetic heart valve1300bto handle1320b. Shaft1328, which may extend through catheter assembly1316b, may have a sharp distal end that is configured to cut sutures1330awhen the shaft is moved distally by a user after inversion of sealing member1322a. AlthoughFIG. 13Billustrates an example of a shaft1328having a sharp distal end, in other examples, the catheter assembly1316bmay include other types of cutting mechanisms. Portions of sutures1330amay remain in the patient with the prosthetic heart valve1300binstead of being removed. Such sutures1330amay be biodegradable.

FIGS. 14A and 14Billustrate a prosthetic heart valve1400that is a variation of prosthetic heart valve300ofFIGS. 3A-3C. Prosthetic heart valve1400has one or more filaments1430, each filament having a coiled portion1432extending through a respective aperture in sealing member1422adjacent its free edge1423. Each filament1430has a proximal end portion (not shown) at an end opposite the coiled portion1432. The proximal end portions of filaments1430may extend through a catheter assembly to an operating handle, such as operating handle20ofFIGS. 10A and 10B, where the proximal end portions may be available for grasping by a user. Coiled portions1432may each comprise a spring steel coil, or, for example, another filamentary element that has a shape memory.

When a user desires to invert sealing member1422from the extended condition ofFIG. 14Ato the inverted condition ofFIG. 14B, the user may grasp the proximal end portions of filaments1430and pull the end portions in a proximal direction. At first, the pulling of filaments1430will cause the sealing member1422to invert, because the force required to unwind coiled portions1432is sufficiently large that the coiled portions will not unwind while the sealing member inverts. The user may continue to pull the end portions proximally, which will cause the coiled portions1432to unwind and withdraw from the respective apertures in sealing member1422. Once the coiled portions1432have completely decoupled from sealing member1422, the user may withdraw filaments1430from the delivery device.

FIGS. 15A and 15Billustrate prosthetic heart valve1500and delivery device1510, which is a variation of prosthetic heart valve300and delivery device10ofFIGS. 10A-10C. Delivery device1510has one or more sutures1530, each suture having a distal end1532affixed to sealing member1522adjacent its free edge1523, and a proximal end1534. Each proximal end1534may include a loop with opening1536therein (FIG. 15B). In this embodiment, sutures1530remain in a patient with prosthetic heart valve1500instead of being removed. Such sutures1530may be biodegradable.

Delivery device1510includes spring arms1526each having a first end1527pivotally coupled to retainer1525and a second end1528remote from the first end. Second end1528of each spring arm1526has a hook feature that forms a radially-inwardly facing acute angle relative to the rest of the spring arm. When spring arms1526are covered by distal sheath1524, the spring arms are retained within recesses1529of retainer1525. When spring arms1526are uncovered by distal sheath1524, the second ends of the spring arms are configured to automatically (i.e., without actuation by the user independent from actuation of distal sheath1524) pivot away from the retainer according to their bias.

During deployment of prosthetic heart valve1500, after distal sheath1524has uncovered the prosthetic heart valve, sealing member1522is initially in the extended condition with distal sheath covering spring arms1526. In this initial condition, proximal ends1534of sutures1530are removably coupled to spring arms1526with second ends1528of the spring arms extending into openings1536of the sutures.

To invert sealing member1522, a user may move distal sheath1524proximally to uncover prosthetic heart valve1500, so that the heart valve self-expands in a radial direction. Since sutures1530extend along the outside surface of prosthetic heart valve1500, the radial expansion of the prosthetic heart valve will push central portions of the sutures radially outward from a longitudinal axis of the valve, thereby shortening the distance between distal end1532and proximal end1534of each suture1530. Since proximal end1534of each suture1530is coupled to delivery device1510by a respective spring arm1526, each distal end1532will be moved closer to its corresponding proximal end, thereby moving sealing member1522to the inverted condition shown inFIG. 15B.

To release sutures1530from delivery device1510, a user may move distal sheath1524further proximally to uncover spring arms1526, and the spring arms will automatically pivot outwardly so that second ends1528are spaced apart from retainer1525. Once spring arms1526have pivoted to the fully outward position shown inFIG. 15B, proximal end1534of each suture1530will slide off the hook feature at second end1528of the respective spring arm as a result of the continued tension applied to the sutures by the spring arms, thereby decoupling the sutures from the spring arms. Before delivery device1510is removed from the patient, the user may pivot spring arms1526back into recesses1529by moving distal sheath1524distally to cover the spring arms.

FIG. 16Aillustrates prosthetic heart valve1600aand delivery device1610a, which is a variation of prosthetic heart valve1500and delivery device1510ofFIGS. 15A and 15B. Delivery device1610aincludes one or more sutures1630a, each suture having a distal end1632aaffixed to sealing member1622adjacent its free edge1623, and a proximal end1634a. Each proximal end1634amay include a loop having an opening therein.

Delivery device1610aincludes lateral posts1626aeach having a first end1627aaffixed to retainer1625aand a second bulbous end1628aremote from the first end. The openings at proximal ends1634aof sutures1630apreferably have approximately the same diameter as the bulbous ends1628a, so that the proximal ends of the sutures won't fall off of the bulbous ends when lateral posts1626aare covered by distal sheath1624, but a small amount of pulling on the sutures will pull the sutures off of the lateral posts. Therefore, when lateral posts1626aare uncovered by distal sheath1624, proximal ends1634aof sutures1630aare free to slip off of the lateral posts if a radially-outward force is applied to the proximal ends of the sutures.

Although bulbous ends1628aare shown as having a bulb shape, any shape of second ends1628amay be used that can removably retain proximal ends1634aof sutures1630aon lateral posts1626awhile distal sheath1624is covering the lateral posts, and that can permit the proximal ends of the sutures to be easily pulled off of the lateral posts when the distal sheath uncovers the lateral posts.

During deployment of prosthetic heart valve1600a, after distal sheath1624has uncovered the prosthetic heart valve, sealing member1622is initially in the extended condition with the distal sheath covering lateral posts1626a. In this initial condition, proximal ends1634aof sutures1630aare removably coupled to lateral posts1626awith the bulbous ends1628aof the lateral posts extending through the openings of the proximal ends of the sutures.

To invert sealing member1622, a user may move distal sheath1624proximally to uncover prosthetic heart valve1600a, so that the heart valve self-expands in a radial direction. Since sutures1630aextend along the outside surface of prosthetic heart valve1600a, the radial expansion of the prosthetic heart valve will push central portions of the sutures radially outward from a longitudinal axis of the valve, thereby shortening the distance between distal end1632aand proximal end1634aof each suture1630a. Since proximal end1634aof each suture1630ais coupled to delivery device1610aby a respective lateral post1626a, each distal end1632awill be moved closer to its corresponding proximal end, thereby moving sealing member1622to the inverted condition shown inFIG. 16A.

To release sutures1630afrom delivery device1610a, once sealing member1622has inverted, the user may continue to move distal sheath1624proximally to uncover lateral posts1626a. The continued radially-outward force applied by prosthetic heart valve1600ato central portions of sutures1630awill push proximal ends1634aof the sutures off of lateral posts1626a, thereby decoupling the valve from delivery device1610a. In this embodiment, sutures1630aremain in a patient with prosthetic heart valve1600ainstead of being removed. Such sutures1630amay be biodegradable.

FIG. 16Billustrates a prosthetic heart valve1600bthat is a variation of prosthetic heart valve1600aofFIG. 16A. Prosthetic heart valve1600bis the same as prosthetic heart valve1600a, except that prosthetic heart valve1600bhas sutures1630bthat extend through openings1669in stent retaining elements1668during the path from free edge1623of sealing member1622to the retainer of a delivery device, such as delivery device1610aofFIG. 16A. Since sutures1630bextend through openings1669in stent retaining elements1668, when prosthetic heart valve1600bis uncovered and radially self-expands, the sutures may more easily maintain their circumferentially-spaced positions about the valve. Such a configuration may result in a more reliable and repeatable inversion of sealing member1622than the embodiment ofFIG. 16A. In such embodiment, when sutures1630bare detached as described above in the previous embodiment, the sutures remain attached to prosthetic heart valve1600band may biodegrade over time.

FIG. 16Cillustrates prosthetic heart valve1600cand delivery device1610c, which is another variation of prosthetic heart valve1500and delivery device1510ofFIGS. 15A and 15B. Delivery device1610chas one or more sutures1630c, each suture having a distal end1632caffixed to sealing member1622adjacent its free edge1623, and a proximal end1634c. Each proximal end1634cmay form a loop having an opening therein.

Delivery device1610cincludes one or more coiled filaments1626chaving a first end1627caffixed to retainer1625cand a second free end1628cat the end of the coil. The coiled filament1626cmay comprise a spring steel coil, or, for example, another filamentary element that has a shape memory.

During deployment of prosthetic heart valve1600c, sealing member1622is initially in the extended condition with distal sheath1624covering the valve. In this initial condition, proximal ends1634cof sutures1630care removably coupled to one or more coiled filaments1626cwith free ends1628cof the coiled filaments extending into the openings at the proximal ends of the sutures.

To invert sealing member1622, a user may move distal sheath1624proximally to uncover prosthetic heart valve1600c, so that the heart valve self-expands in a radial direction. Since sutures1630cextend along the outside of prosthetic heart valve1600c, the radial expansion of the prosthetic heart valve will push central portions of the sutures radially outward from the longitudinal axis of the valve, thereby shortening the distance between distal end1632cand proximal end1634cof each suture1630c. Since proximal ends1634cof sutures1630care coupled to delivery device1610cby one or more coiled filaments1626c, each distal end1632awill be moved closer to its corresponding proximal end, thereby moving sealing member1622to the inverted condition shown inFIG. 16C.

Once sealing member1622has inverted, the user may decouple proximal ends1634cof sutures1630cfrom the one or more coiled filaments1626cby pulling delivery device1610cin a proximal direction. Because the frictional force between prosthetic heart valve1600cand the native anatomy will be greater than the force required to unwind coiled filaments1626c, as the user pulls delivery device1610cproximally, the coiled filaments will unwind and withdraw from the openings in proximal ends1634cof sutures1630c, thereby decoupling the valve from the delivery device.

FIG. 17illustrates prosthetic heart valve1700, which is a variation of prosthetic heart valve1600cofFIG. 16C. Prosthetic heart valve1700is the same as prosthetic heart valve1600c, except that sutures1730include coiled links1726in a central portion thereof.

Each suture1730has a distal portion1730aextending between free edge1723of sealing member1722and a first end1727of a corresponding coiled link1726, and a proximal portion1730bextending between a second end1728of the corresponding coiled link1726and the retainer of a delivery device, such as delivery device1610c. The distal portion1730aof suture1730forms a loop having an opening therein that is configured to have first end1727of coiled link1726extend therethrough. Proximal portion1730bof suture1730also forms a loop having an opening therein that is configured to have second end1728of coiled link1726extend therethrough. Each coiled link1726may comprise a portion of a spring steel coil.

To ensure that link1726may disengage from distal portion1730aof suture1730to release prosthetic heart valve1700from a delivery device, second end1728of the link may be fixedly connected to proximal portion1730bof the suture, for example, using an adhesive. Alternatively, second end1728of link1726may form a closed loop or may incorporate a boss having a width greater than a diameter of the looped end of proximal portion1730bof suture1730, such that the proximal portion of the suture may be fixedly retained on the second end of the link.

The deployment of prosthetic heart valve1700is performed identically to the deployment of prosthetic heart valve1600cdescribed above, except that once sealing member1722has inverted, the user may decouple distal portions1730aof sutures1730from the corresponding coiled links1726by pulling the delivery device in a proximal direction. Because the frictional force between the prosthetic heart valve1700and the native anatomy will be greater than the force required to unwind first end1727of coiled links1726, as the user pulls the delivery device proximally, the first ends of the coiled links will unwind and withdraw from the openings in distal portions1730aof sutures1730, thereby decoupling the valve from the delivery device.

FIGS. 18A-18Cillustrate a prosthetic heart valve1800that is a variation of prosthetic heart valve300ofFIGS. 3A-3C. Prosthetic heart valve1800has stent portion1806configured to be deployed within the native aortic annulus of a patient, and an expandable anchor portion1801configured to be deployed within the ascending aorta as shown inFIG. 18C. Anchor portion1801may have covering1802made of a porous fabric suitable for tissue ingrowth, for example.

Prosthetic heart valve1800has one or more filaments1830(e.g., wires, sutures, or any of the other filamentary structures described above) each having a first end1831affixed to sealing member1822adjacent its free edge1823, and a second end1832affixed to anchor portion1801. When prosthetic heart valve1800is in its expanded state, anchor portion1801retains sealing member1822in its inverted condition via filaments1830extending between the anchor portion and stent portion1806. In one embodiment, filaments1830may take the form of sutures. Filaments1830may be biodegradable sutures that may dissolve once tissue ingrowth is sufficient to retain anchor portion1801and stent portion1806in their deployed locations.

During deployment of prosthetic heart valve1800, sealing member1822is initially in the extended condition shown inFIG. 18Awith the distal sheath of a delivery device (e.g., the delivery device10ofFIGS. 10A and 10B) covering stent portion1806and anchor portion1801. To deploy stent portion1806, a user may move the distal sheath proximally to uncover prosthetic heart valve1800, so that the heart valve self-expands in a radial direction, while anchor portion1801remains covered by the distal sheath.

To invert sealing member1822, the user may pull the delivery device in a proximal direction. Because the frictional force between stent portion1806and the native anatomy will be greater than the force required to invert sealing member1822, as the user pulls the delivery device proximally, sutures1830will move the sealing member to the inverted condition shown inFIGS. 18B and 18C.

Once sealing member1822has been inverted, the user may deploy anchor portion1801by continuing to move the distal sheath proximally to uncover the anchor portion, so that the anchor portion self-expands in a radial direction. Once anchor portion1801has been deployed, the delivery device may be removed from the patient.

Although various sealing structures have been described herein as “sealing rings,” it is to be understood that the term “sealing ring” as used herein may describe one or more discontinuous sealing structures that do not completely extend around the circumference of the stent of a prosthetic heart valve.

Although many of the embodiments herein have been described as having sutures, any of such sutures may be replaced with other filamentary elements, such as at least one polymer wire, braided metal wire, Nitinol wire, cord, ribbon, or any other connecting member that may be used to pull the corresponding sealing member to an inverted condition or a contracted condition.

In summary, the disclosure herein recites multiple embodiments. Described herein is a prosthetic heart valve configured to be expanded proximate a native valve of a patient. The prosthetic heart valve may include a collapsible and expandable stent having a proximal end, a distal end, an annulus section adjacent the proximal end, and a plurality of cells connected to one another in a plurality of annular rows around the stent, a cuff attached to the annulus section of the stent and defining an outward-facing surface, a plurality of prosthetic valve leaflets attached to the cuff, and a sealing member attached to the cuff and extending from a proximal end of the cuff to a free edge. The stent may have a flow direction extending from the proximal end of the stent toward the distal end of the stent. The sealing member may be movable between an extended condition in which the free edge is located proximally of the proximal end of the stent, and an inverted condition in which the free edge is located distally of the proximal end of the stent and a first surface of the sealing member confronts the outward-facing surface of the cuff; and/or

the sealing member in the extended condition may be located entirely below the proximal end of the stent; and/or

the sealing member in the inverted condition may extend continuously around a circumference of the stent; and/or

the prosthetic heart valve may also include a sealing ring attached to a second surface of the sealing member opposite the first surface, wherein in the inverted condition of the sealing member and in an expanded use condition of the stent, the sealing ring may have a diameter greater than a diameter of the proximal end of the stent; and/or

in the extended condition of the sealing member, the sealing ring may be located entirely proximally of the proximal end of the stent; and/or

the prosthetic heart valve may also include a stored energy element inside the sealing ring, wherein in the inverted condition of the sealing member the stored energy element is biased to provide a force to an outer edge of the sealing ring in a direction orthogonal to the flow direction when the outer edge is radially compressed; and/or

the stored energy element may include a spring that extends in at least one complete loop about a circumference of the sealing ring; and/or

the prosthetic heart valve may also include a plurality of retractable wires extending between a first position on the stent and a second position near the free edge of the sealing member, the retractable wires having a first length in the extended condition of the sealing member and a second length in the inverted condition of the sealing member, the second length being shorter than the first length.

Also described herein is another prosthetic heart valve configured to be expanded proximate a native valve of a patient. The prosthetic heart valve may include a collapsible and expandable stent having a proximal end, a distal end, an annulus section adjacent the proximal end, and a plurality of cells connected to one another in a plurality of annular rows around the stent, a cuff attached to the annulus section of the stent and defining an outward-facing surface, a plurality of prosthetic valve leaflets attached to the cuff, and a sealing member attached to the cuff and extending from a proximal end of the cuff to a free edge. The stent may have a flow direction extending from the proximal end of the stent toward the distal end of the stent. The sealing member may be movable between an extended condition in which the free edge is located a first distance proximally of the proximal end of the stent, and a compressed condition in which the free edge is located a second distance proximally of the proximal end of the stent; and/or

in the compressed condition of the sealing member and in an expanded use condition of the stent, the sealing member may have a diameter greater than a diameter of the proximal end of the stent; and/or

in the compressed condition of the sealing member and in an expanded use condition of the stent, the sealing member may have a plurality of alternating peaks and valleys extending in the circumferential direction of the stent, the peaks being located at a greater radial distance away from the stent than the valleys; and/or

in the compressed condition of the sealing member and in the expanded use condition of the stent, each of the peaks may have an adjacent valley proximal to at least a portion of the respective peak, and each of the peaks may have a central portion that extends proximally of the respective adjacent valley.

Also described herein is a method of expanding a prosthetic heart valve proximate a native valve of a patient. The prosthetic heart valve may include a stent having proximal and distal ends, a cuff attached to the stent, and a sealing member extending from a proximal end of the cuff to a free edge.

The method may include collapsing the prosthetic heart valve into a delivery device such that the sealing member is in an extended condition in which the free edge is located proximally of the proximal end of the stent, inserting the delivery device into a patient, advancing the delivery device proximate an annulus of the native valve, partially expanding the prosthetic heart valve in a selected position proximate the native valve, moving the sealing member from the extended condition to an inverted condition in which the free edge is located distally of the proximal end of the stent, and fully expanding the prosthetic heart valve; and/or

the sealing member in the extended condition may be located entirely proximally of the proximal end of the stent; and/or

the sealing member may include wires extending from the free end of the sealing member through the delivery device to a location outside the patient, and the moving step may include pulling the wires to move the free edge of the sealing member; and/or

the method may also include withdrawing the wires from the patient while leaving the prosthetic heart valve inside the patient; and/or

after the moving step, a first surface of the sealing member may confront an outward-facing surface of the cuff; and/or

the prosthetic heart valve may also include a sealing ring attached to a second surface of the sealing member opposite the first surface, and the moving step may include inverting the sealing ring from an inward-facing condition to an outward-facing condition in which the sealing ring has a diameter greater than a diameter of the proximal end of the stent; and/or

in the extended condition of the sealing member, the sealing ring may be located entirely proximally of the proximal end of the stent; and/or

the sealing member may include wires extending between a first position on the stent and a second position near the free edge of the sealing member, the collapsing step may include extending the wires to a first length, and the moving step may include contracting the wires to a second length shorter than the first length.

Also described herein is a system including a delivery device and a prosthetic heart valve. The delivery device may include an operating handle and a catheter assembly. The catheter assembly may include a first shaft around which a compartment is defined, the first shaft being operatively connected to the operating handle, and a distal sheath at least partially surrounding the first shaft, the distal sheath being moveable between a closed condition covering the compartment and an open condition uncovering the compartment for deployment of the valve.

The prosthetic heart valve may be mounted in the compartment. The prosthetic valve may include a collapsible and expandable stent, a cuff, and a sealing member attached to the cuff. The stent may have a proximal end, a distal end, and an annulus section adjacent the proximal end, the stent having a flow direction extending from the proximal end toward the distal end. The cuff may be attached to the annulus section of the stent and may define an outward-facing surface.

The sealing member may extend from a proximal end of the cuff to a free edge, the sealing member being movable between an extended condition in which the free edge is located at a first location proximally of the proximal end of the stent, and a use condition in which the free edge is located at a second location distally of the first location and a first surface of the sealing member confronts the outward-facing surface of the cuff. The sealing member may have an energy storage element with a bias to move the sealing member toward the use condition. The catheter assembly may have a restraining member removably coupled to the sealing member to hold the sealing member in the extended condition against the bias of the energy storage element; and/or

the restraining member may be a peg affixed to a wire, the wire extending through the catheter assembly to the operating handle; and/or

the restraining member may be a peg affixed to a second energy storage element that extends between the peg and the distal sheath, and the second energy storage element may be configured to store energy when the distal sheath is moved toward the operating handle; and/or the restraining member may be coupled to the valve by filaments that are configured to break when the distal sheath is moved toward the operating handle beyond a predetermined distance.

Also described herein is another system including a delivery device and a prosthetic heart valve. The delivery device may include an operating handle and a catheter assembly. The catheter assembly may include a first shaft around which a compartment is defined, the first shaft being operatively connected to the operating handle, and a distal sheath at least partially surrounding the first shaft, the distal sheath being moveable between a closed condition covering the compartment and an open condition uncovering the compartment for deployment of the valve.

The prosthetic heart valve may be mounted in the compartment. The prosthetic valve may include a collapsible and expandable stent, a cuff, and a sealing member attached to the cuff. The stent may have a proximal end, a distal end, and an annulus section adjacent the proximal end, the stent having a flow direction extending from the proximal end toward the distal end. The cuff may be attached to the annulus section of the stent and may define an outward-facing surface.

The sealing member may extend from a proximal end of the cuff to a free edge, the sealing member being movable between an extended condition in which the free edge is located at a first location proximally of the proximal end of the stent, and a use condition in which the free edge is located at a second location distally of the first location and a first surface of the sealing member confronts the outward-facing surface of the cuff. The catheter assembly may have an actuating filament having a portion removably coupled to the sealing member and configured to move the sealing member from the extended condition to the use condition when the portion of the actuating filament is moved toward the operating handle; and/or

the actuating filament may be configured to move the sealing member from the extended condition to the use condition when the entire actuating filament is pulled toward the operating handle; and/or

the actuating filament may be configured to move the sealing member from the extended condition to the use condition when the portion of the actuating filament is moved toward the operating handle by a first distance, and may be configured to decouple from the sealing member when the portion of the actuating filament is moved toward the operating handle by a second distance greater than the first distance; and/or

the actuating filament may include a coiled spring portion that is configured to unwind when the portion of the actuating filament is moved toward the operating handle by the second distance; and/or

the actuating filament may include a proximal portion operatively coupled to the distal sheath, and a distal portion operatively coupled to the sealing member, and the coiled spring portion may removably couple the proximal portion to the distal portion.

Also described herein is another system including a delivery device and a prosthetic heart valve. The delivery device may include an operating handle and a catheter assembly. The catheter assembly may include a first shaft around which a compartment is defined, the first shaft being operatively connected to the operating handle, and a distal sheath at least partially surrounding the first shaft, the distal sheath being moveable between a closed condition covering the compartment and an open condition uncovering the compartment for deployment of the valve.

The prosthetic heart valve may be mounted in the compartment. The prosthetic valve may include a collapsible and expandable stent, a cuff, and a sealing member attached to the cuff. The stent may have a proximal end, a distal end, and an annulus section adjacent the proximal end, the stent having a flow direction extending from the proximal end toward the distal end. The cuff may be attached to the annulus section of the stent and may define an outward-facing surface.

The sealing member may extend from a proximal end of the cuff to a free edge, the sealing member being movable between an extended condition in which the free edge is located at a first location proximally of the proximal end of the stent, and a use condition in which the free edge is located at a second location distally of the first location and a first surface of the sealing member confronts the outward-facing surface of the cuff. The catheter assembly may have an actuating filament removably coupled to a retaining element of the catheter assembly and configured to move the sealing member from the extended condition to the use condition when a portion of the actuating filament is moved toward the operating handle; and/or

a proximal end of the actuating filament may be removably coupled to the delivery device, and the actuating filament may be configured to move the sealing member from the extended condition to the use condition when the portion of the actuating filament is moved toward the proximal end of the actuating filament; and/or

the delivery device may also include a cutting tool configured to decouple at least a portion of the actuating filament from the retaining element, the portion of the actuating filament being biodegradable; and/or

the retaining element may be a pivotable arm configured to retain a proximal end of the actuating filament when the arm is covered by the distal sheath, and to release the proximal end of the actuating filament when the distal sheath is moved proximally to uncover the arm; and/or

the retaining element may be a post extending away from the first shaft in a lateral direction of the catheter assembly, the post being configured to retain a proximal end of the actuating filament when the post is covered by the distal sheath and configured to release the proximal end of the actuating filament when the distal sheath is moved proximally to uncover the post.

Also described herein is another system including a delivery device and a prosthetic heart valve. The delivery device may include an operating handle and a catheter assembly. The catheter assembly may include a first shaft around which a compartment is defined, the first shaft being operatively connected to the operating handle, and a distal sheath at least partially surrounding the first shaft, the distal sheath being moveable between a closed condition covering the compartment and an open condition uncovering the compartment for deployment of the valve.

The prosthetic heart valve may be mounted in the compartment. The prosthetic valve may include a collapsible and expandable stent, a cuff, a sealing member attached to the cuff, an expandable anchor portion having a generally cylindrical shape, and an actuating filament. The stent may have a proximal end, a distal end, and an annulus section adjacent the proximal end, the stent having a flow direction extending from the proximal end toward the distal end. The cuff may be attached to the annulus section of the stent and may define an outward-facing surface.

The sealing member may extend from a proximal end of the cuff to a free edge, the sealing member being movable between an extended condition in which the free edge is located at a first location proximally of the proximal end of the stent, and a use condition in which the free edge is located at a second location distally of the first location and a first surface of the sealing member confronts the outward-facing surface of the cuff. The actuating filament may extend between the free edge of the sealing member and the expandable anchor portion, the actuating filament configured to move the sealing member from the extended condition to the use condition when the expandable anchor portion is moved toward the operating handle; and/or

the anchor portion may comprise a covering including a porous material configured to receive tissue ingrowth; and/or

the sealing member may include a porous material configured to receive tissue ingrowth, and the actuating filament may be biodegradable.

Also described herein is a method of expanding a prosthetic heart valve proximate a native valve of a patient. The prosthetic heart valve may include a stent having proximal and distal ends, a cuff attached to the stent, and a sealing member extending from a proximal end of the cuff to a free edge.

The method may include collapsing the prosthetic heart valve into a delivery device such that the sealing member is in an extended condition in which the free edge is located proximally of the proximal end of the stent, inserting the delivery device into a patient, advancing the delivery device proximate an annulus of the native valve, expanding the prosthetic heart valve from a first diameter to a second diameter greater than the first diameter in a selected position proximate the native valve, and moving the sealing member from the extended condition to a use condition in which the free edge is located at a second location distally of the first location; and/or

the steps of expanding the prosthetic heart valve and moving the sealing member may be performed simultaneously; and/or

the step of moving the sealing member may be performed by removing a restraining member from the sealing member to permit an energy storage element of the sealing member to move the sealing member to the use condition; and/or

the step of moving the sealing member may be performed by moving a portion of an actuating filament toward an operating handle of the delivery device by a first distance; and/or

the method may also include decoupling the actuating filament from the prosthetic heart valve by moving the portion of the actuating filament toward the operating handle by a second distance greater than the first distance.